Midweek report

Patient safety

Midweek report

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

From Washington, DC

  • Bloomberg Law notes,
    • Gender-affirming care will no longer be covered for federal workers in 2026, according to a letter the Trump administration sent to insurance carriers. * * *
    • The announcement, dated Aug. 15, cements the administration’s expected move to halt gender-affirming care following President Donald Trump’s January executive order to enforce laws based on a person’s biological sex. The exclusion likely tees up legal challenges under Title VII of the 1964 Civil Rights Act and Section 1557 of the Affordable Care Act, both of which contain anti-discrimination protections.
    • “This discriminatory policy denying medical care to government employees and their dependents is not only cruel—it is illegal,” Omar Gonzalez-Pagan, Lambda Legal counsel and health-care strategist, said in a statement. “The federal government cannot simply strip away essential healthcare coverage from transgender employees while providing comprehensive medical care to all other federal workers.”
  • The American Hospital Association News points out,
    • “A JAMA study published Aug. 18 found that plan design changes by Medicare Part D insurers, particularly for Medicare Advantage plans, following passage of the Inflation Reduction Act of 2022 could lead to higher cost sharing for some beneficiaries who do not reach the $2,000 out-of-pocket maximum for prescription drug coverage in 2025. Researchers said policies prevented premium increases in 2025, but Part D plans may have responded by increasing deductibles or medication cost sharing. The study found mean deductibles for MA plans decreased from $153 in 2019 to $66 in 2024, before sharply increasing to $228 for 2025. Additionally, the proportion of MA beneficiaries with coinsurance for preferred brand-name drugs ranged from 0.8% to 2.5% from 2019 to 2024, before increasing to 27.7% in 2025.”
  • BioPharma Dive tells us,
    • “A much-anticipated report from the Make America Healthy Again Commission was postponed earlier this month. But nestled within leaked documents is a strategy that reveals more about health leaders’ goals, including potential new oversight of pharma’s direct-to-consumer advertising practices.
    • “DTC advertising has long been a target of Health and Human Services Secretary and MAHA leader Robert F. Kennedy Jr. While Congress has taken some interest in passing a ban on those ads, real reform hasn’t gained momentum.” * * *
    • “Listed under “policy reforms” within the draft, the focus on DTC advertising states that the FDA, HHS, the Federal Trade Commission and Department of Justice would “increase oversight and enforcement” under current laws for DTC prescription drug advertising violations. Instead of focusing on all media platforms, the agencies will “prioritize the most egregious violations,” such as those by social media influencers and telehealth companies.”
  • AP reports,
    • “When the Food and Drug Administration needs outside guidance, it normally turns to a trusted source: a large roster of expert advisers who are carefully vetted for their independence, credentials and judgment.
    • “But increasingly, the agency isn’t calling them.
    • “Instead, FDA Commissioner Marty Makary has launched a series of ad hoc “expert panels” to discuss antidepressants, menopause drugs and other topics with physicians and researchers who often have contrarian views and financial interests in the subjects.”

From the judicial front,

  • Beckers Payer Issues informs us,
    • “A federal judge has approved a $2.8 billion settlement resolving antitrust claims brought by healthcare providers against the Blue Cross Blue Shield Association and its independent entities, ending more than a decade of litigation.
    • “The settlement was approved Aug. 19 and covers a class of millions of hospitals, physician practices, and other providers nationwide who accused the Blues of conspiring to divide up markets to avoid competing with one another, which allegedly drove up costs and reduced reimbursements.
    • “Under the agreement, about $1.78 billion will be distributed to healthcare facilities, while $152 million is earmarked for medical professionals. The settlement also implements structural reforms valued at more than $17 billion, including how BCBS plans process claims, and how they communicate, contract with, and make payments to providers. The settlement applies to providers who treated BCBS members between July 2008 and October 2024.”
  • Per Healthcare Dive,
    • “A federal judge has vacated a Biden-era rule that would have curbed Medicare Advantage plans’ payouts to agents and brokers.
    • “On Monday, Judge Reed O’Connor of the Texas Northern District Court ruled that the CMS overstepped its authority in trying to cap payments to MA sales organizations beyond direct compensation, and in prohibiting contracts that incentivize brokers to steer seniors to specific plans.
    • “CMS may only regulate how compensation is used, not engage in ratemaking,” O’Connor wrote in his decision. It’s a loss for smaller plans, which argue that the status quo benefits larger and wealthier insurers, and a setback for efforts to curb predatory marketing in the privatized Medicare program.”
  • and
    • “Elevance has lost a legal bid to improve its Medicare Advantage quality ratings for 2025.
    • “On Monday, a Texas federal judge threw out the insurer’s suit and offered a biting indictment of Elevance’s legal argument, saying it relied on distorted math.
    • “The lower star ratings will cost Elevance at least $375 million in bonus payments and rebates.”
  • Per a U.S. Justice Department news release,
    • “Troy Health, Inc. (Troy), a North Carolina-based provider of Medicare Advantage, Medicare Part D, and Dual Eligible Special Needs Plans, has entered into a non-prosecution agreement with the Department of Justice to resolve a criminal investigation into a health care fraud and identity theft scheme involving the use of artificial intelligence and automation software to illegally obtain Medicare beneficiary information and fraudulently enroll beneficiaries into its Medicare Advantage plans.
    • “Troy told low-income Medicare beneficiaries that it would use new technologies, including its proprietary artificial intelligence platform, to improve patient health outcomes,” said Acting Assistant Attorney General Matthew Galeotti of the Justice Department’s Criminal Division. “Instead, the company misused patient data to enroll beneficiaries in its Medicare Advantage plan without their consent. Today’s resolution reflects the Criminal Division’s emerging focus on corporate enforcement in the health care space and holding both individuals and companies accountable when they defraud our medical system to enrich themselves at the expense of the American taxpayer.”
  • Per a news release from the U.S. Attorney for the Northern District of California,
    • “American Psychiatric Centers, Inc., doing business under the name Comprehensive Psychiatric Services (CPS), has agreed to pay $2.75 million to resolve allegations that CPS violated the False Claims Act by submitting false claims to government healthcare payors for certain psychotherapy services.
    • “CPS, which is headquartered in Walnut Creek, Calif., provides behavioral medicine services for individuals and families in the State of California.  Since at least 2015, CPS and its healthcare providers have submitted claims to government payors using Current Procedural Terminology codes 90833 and 90836, which are “add-on” codes to be used when psychotherapy services are performed in conjunction with an evaluation and management visit, and which require specific documentation.
    • “The settlement announced today resolves the government’s allegations that, from Jan. 1, 2015, through Dec. 31, 2022, CPS submitted fraudulent claims using these add-on codes in instances where its healthcare providers either had not provided the services described by those codes or had failed to sufficiently document that such services had been provided.  CPS will pay $2,615,569.32 to the United States and $134,430.68 to the State of California. * * *
    • “False claims increase costs and undermine the integrity of our federal health care programs, including the Federal Employees Health Benefits Program,” said Derek M. Holt, Special Agent in Charge, the U.S. Office of Personnel Management Office of the Inspector General (OPM OIG). “We support the work of our law enforcement partners and colleagues to investigate fraudulent medical billing that wastes taxpayer dollars.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of August 19, 2025, a total of 1,375 confirmed measles cases were reported by 42 jurisdictions: Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, Nebraska, New Jersey, New Mexico, New York City, New York State, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin, and Wyoming.
    • “There have been 35 outbreaks reported in 2025, and 87% of confirmed cases (1,190 of 1,375) are outbreak-associated. For comparison, 16 outbreaks were reported during 2024 and 69% of cases (198 of 285) were outbreak-associated.”
  • Per Medscape,
    • “The experimental drug obicetrapib, a potent oral cholesteryl ester transfer protein (CETP) inhibitor, significantly slowed Alzheimer’s disease (AD) biomarker progression over 12 months in patients with cardiovascular disease, new research showed.
    • “Results revealed the drug led to a 20% improvement in levels of phosphorylated tau 217 (p-tau217) — an important indicator of AD pathology — in patients carrying the apolipoprotein E (APOE4) allele. About 65% of people with AD are APOE4 carriers.
    • “The treatment was already shown to reduce LDL cholesterol and increase HDL cholesterol in patients with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH).
    • “It’s encouraging to have a drug that treats cardiovascular disease and treats or prevents AD, study investigator Philip Scheltens, MD, PhD, professor of neurology and founder of the Alzheimer’s Center, Amsterdam University Medical Center, Amsterdam, the Netherlands, told Medscape Medical News.“
  • Per the University of Minnesota’s CIDRAP,
    • “Non-White US Lyme disease patients with Medicaid or Medicare coverage were more likely than their White peers to be female, hospitalized at diagnosis, diagnosed outside of primary care and the summer months, and to have disseminated disease (more widespread in the body), per a new study by Pfizer scientists co-developing a vaccine against the tick-borne infection with Valneva.
    • “From 2016 to 2021, the researchers analyzed claims-based data from 15 Lyme-prevalent states and Washington, DC, on Medicaid beneficiaries 18 years and younger and 19 and older and Medicare fee-for-service beneficiaries younger than 65 and 65 and older. 
    • “The findings were published Monday in Emerging Infectious Diseases.”
  • Medscape also calls attention to five things to know about cervical cancer.
  • Per the AHA News,
    • “B. Braun Medical has voluntarily recalled two lots of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL IV fluids due to particles inside the container, according to the Food and Drug Administration. The company said there have been no reports of serious injury, death or other adverse events associated with the issue. B. Braun said affected products should be returned to the company and not be destroyed.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health insurance companies are looking to cut costs by ranking providers like they tier pharmaceuticals.
    • “Last week, HealthPartners announced plans to offer large employers its Simplica NextGen Copay, a plan that sets fixed copays by provider and eliminates coinsurance and deductibles. CVS Health subsidiary Aetna is rolling out Aetna Informed Choice, a new plan for employers based on its variable copay plan, a spokesperson said in an email. In February, Blue Cross and Blue Shield of Minnesota launched a new investment arm focused on developing tools for its variable copay plan, Coupe Health.
    • “There’s been a resurgence in them,” said Katherine Hempstead, senior policy officer at the Robert Wood Johnson Foundation, a healthcare research philanthropy. 
    • “Variable copay plans are part of the tide of alternative health plans that have emerged in recent years, promising to help employers save costs without shifting more of the expenses to employees by raising deductibles. Like high-deductible plans, variable copay plans operate on the assumption that giving consumers “skin in the game” will drive them to select the most cost-effective service. High-deductible plans often raise costs for patients and insurers because high upfront costs drive patients to forego preventive care or drugs needed to manage their condition, worsening their health, according to a 2018 study by the University of Southern California Leonard D. Schaeffer Center Institute for Public Policy and Government Service. 
    • “The variable copay plans are constructed similarly to a tiered provider network, a long-standing health insurance benefits design that gives members the option of seeing the full array of providers but lowers cost-sharing if enrollees choose the preferred clinicians. 
    • “These are not new and not shiny,” said Sabrina Corlette, co-director of the Georgetown University Center on Health Insurance Reforms.”
  • Per Beckers Hospital Review,
    • Rochester, Minn.-based Mayo Clinic recorded an income from current activities of $380 million (7.1% margin) in the second quarter of 2025 quarter, down from $449 million (8.9% margin) during the same period last year, according to its Aug. 18 financial report. 
    • Total operating revenue was $5.3 billion for the three months ended June 30, up from $5 billion during the same period last year. Mayo’s net patient service revenue was $4.5 billion, an 8.6% increase year over year. The system attributed the growth to strong outpatient, surgical and hospital volumes, as well as increased service demand. 
  • and
    • “Somerville, Mass.-based Mass General Brigham recorded an operating income of $74.4 million (1.3% operating margin) in the third quarter of 2025, up from $47.2 million (0.9% margin) during the same period last year, according to its Aug. 15 financial report. 
    • “The system reported total operating revenue of $5.8 billion for the three months ended June 30, a 12% increase year over year. Patient care revenue totaled $3.7 billion, an 8% increase year over year. The system said this reflected a 3% increase in acute care discharges. Premium revenue increased 19% year over year to $671 million.”
  • Modern Healthcare adds,
    • Hospital costs are growing as an increasing number of sicker patients visit the emergency department, according to a new report.
    • “The average cost of an inpatient stay rose 4.8% from mid-2023 to early 2025, according to the latest national data from Sg2, a data analytics company owned by group purchasing organization Vizient. At academic medical centers, per-case cost growth nearly doubled the rate of expense inflation at community hospitals between the first quarters of 2022 and 2025.
    • “Most people arriving at emergency departments require immediate attention, which may help explain why treatment costs are increasing. Hospitals are having a tough time keeping up with demand for care as the population ages, leading to overcrowded ERs and full inpatient units. 
    • “Providers are expected to get even busier over the next 10 years, potentially creating more care backlogs, according to the report.” 
  • Beckers Hospital Review also shares RN median hourly rates by state.
    • “Median hourly base pay for registered nurses varies across states, with RNs in California earning the most, according to SullivanCotter’s “2025 Health Care Staff Compensation Survey Report.”
    • “The survey, released in July, covers nearly 2.5 million healthcare employees across over 2,660 participating organizations, including more than 800,000 individual RNs, licensed practical nurses and nursing managers.”
  • MedTech Dive offers an interview with Josep Solà, the CEO of Aktiia, whose company received In July, FDA authoriz[ation for] the first over-the-counter cuffless blood pressure monitor.
  • and tells us
    • “Venture capital investment in medtech surged at the start of 2025, prompting PitchBook to forecast a strong year ahead for funding in the sector after several sluggish years.
    • “The market data research firm counted 11 rounds worth at least $100 million each, and $4.1 billion in total venture capital funding in the first quarter alone. Brain implant startup Neuralink’s $650 million Series E financing, announced in June, was a standout as momentum continued in the second quarter.
    • “In a steady stream of private financings this summer, heart devices have been a focus. In July, Kardium announced it raised $250 million as it prepares to launch its pulsed field ablation system for atrial fibrillation, and Field Medical brought in another $35 million to study PFA in ventricular tachycardia.”
  • Beckers Hospital Review relates,
    • “Walgreens Specialty Pharmacy, which earned $25.9 billion last year from U.S. prescription revenue, has expanded its limited distribution drug portfolio to 265 medications, the company said Aug. 19. 
    • “Limited distribution drugs are specialty medications that have complex regimens, high costs and/or special handling requirements. Therapies for chronic diseases and cancers are typically administered at specialty pharmacies. These medications account for about 75% of drugs in development, according to Walgreens. 
    • “The company’s specialty pharmacy added leukemia drug Imkeldi (imatinib), HIV preventive Yeztugo (lenacapavir) and chronic skin condition treatment Imkeldi (imatinib) to its network.” 

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, NCQA, NIH, OPM, Patient safety, U.S. Healthcare–

From Washington, DC,

  • OPM Director Scott Kupor, who is a lawyer, posted his latest blog entry today. The post is titled “Building Momentum Through Legal Wins.”
  • STAT News reports,
    • “US Health Secretary Robert F. Kennedy Jr.’s regulatory roadmap shows the Trump administration plans to continue efforts scaling back on gender-affirming care, advancing its Make America Healthy Again agenda, and restructuring how it grapples with Covid-19 vaccines.
    • “The US government on Friday posted the semi-annual regulatory agenda that details planned rulemaking for the Department of Health and Human Services, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, and other federal health agencies.
    • “The agenda was originally posted online Friday morning but later was removed and replaced with an “under maintenance” message. The Office of Management and Budget’s press office did not immediately respond to an email seeking comment.”
  • The reginfo.gov website on which the semi-annual regulatory agenda is posted still says “The system is under maintenance. It will be back shortly” at 6 pm ET.
  • OPM circulated a last minute 2026 benefit change via this carrier letter (Dropbox link).
    • “For Plan Year 2026, chemical and surgical modification of an individual’s sex traits through medical interventions (to include “gender transition” services) will no longer be covered under the FEHB or PSHB Programs. This exclusion expands upon Carrier Letter 2025-01a and applies regardless of age.”
    • The letter also describes exceptions to this rule.
  • The Hill informs us,
    • “By the end of 2025, the Trump administration likely will have shed around 300,000 workers, Office of Personnel Management Director Scott Kupor told Reuters on Thursday.
    • “The mass departures, which Kupor claimed were largely accounted for by voluntary buyouts rather than firings, would constitute a 12.5 percent reduction of the federal workforce from when President Trump was inaugurated in January.”
  • Federal News Network reports,
    • “The Office of Personnel Management has officially canceled this year’s version of the signature survey that assesses governmentwide satisfaction and engagement levels of federal employees.
    • “In a memo distributed to agency chief human capital officers on Friday afternoon, obtained by Federal News Network, OPM said after initially only delaying the survey, it has now fully scrapped plans to conduct the 2025 Federal Employee Viewpoint Survey.”
  • The American Hospital Association tells us,
    • “The Centers for Medicare & Medicaid Services Innovation Center Aug. 12 released an FAQ on the Wasteful and Inappropriate Service Reduction Model, a six-year technology-enabled prior authorization program pilot. CMS will partner with third-party entities to implement the program for a specified list of services delivered to patients with Original Medicare. The FAQs address patient rights, the coverage review process for beneficiaries and providers, safeguarding against inappropriate denials, protecting patient data and more. The model begins Jan. 1.”
  • and
    • “The Health Resources and Services Administration has awarded more than $15 million in grants to 58 rural health organizations for four-year projects as part of the Federal Office of Rural Health Policy’s Rural Health Care Services Outreach program. The awardees must use innovative, evidence-informed models to address health care needs unique to their communities that are designed to expand access to care and improve health outcomes. The projects will be conducted by a local network of partnering organizations that may include rural hospitals, community-based organizations, health departments, schools, health centers, rural health clinics, academic institutions and other local and state entities.  
  • NCQA, writing in LinkedIn, informs us,
    • “NCQA and The Praxis Project are collaborating on a perinatal measure development project to create, validate and implement an actionable set of measures that align health plans toward improving perinatal health. The project team is developing up to eight new measures for potential inclusion in HEDIS® (Healthcare Effectiveness Data and Information Set) and in other national accountability programs.
    • “Currently, the teams are seeking testing partners—health plans, health systems, state agencies, community-based organizations, Federally Qualified Health Centers, birth centers—to help evaluate the feasibility, validity, reliability and usability of the new measures through a learning network, beginning this fall.”

From the Food and Drug Administration front,

  • BioPharma Dive lets us know,
    • “The Food and Drug Administration granted full approval to a first-of-its-kind treatment for recurrent respiratory papillomatosis, a rare and potentially life-threatening condition caused by persistent HPV infections. Thursday’s clearance of Precigen’s Papzimeos, an immunotherapy that helps clear HPV-infected cells, was based on study results showing a little more than half of drug recipients didn’t need surgery within a year of therapy. Center for Biologics Evaluation and Research director Vinay Prasad, who rejoined the FDA this week, described the approval as proof “randomized trials are not always needed to approve medical products.”
  • Cardiology Business reports,
    • “The U.S. Food and Drug Administration (FDA) is warning the public about ongoing safety issues with a series of cannulae used to vent the left side of the heat during cardiopulmonary bypass surgery procedures. The agency’s alert includes dozens of lots of Medtronic’s DLP Left Heart Vent Catheters with malleable bodies and vented connectors. 
    • “The FDA put this early alert in place after receiving multiple reports of the catheters “resisting shape retention when being bent.” The devices were specifically designed to be easy to bend, holding their shape in a way that helps clinicians work in safe, efficient manner. When the devices fail to retain their shape, however, it can cause delays in care while a replacement catheter is located. 
    • “If the issue is not identified prior to use and the clinician uses the cannula, it may lead to abrasion and perforation (cuts),” according to the FDA’s advisory. “Perforation of critical heart tissue may potentially lead to death if it is complicated, unnoticed or untreated.”
    • “This issue has been linked to three serious injuries as of July 28. No patient deaths have been reported.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many areas of the country. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is going up across the country. Emergency department visits for COVID-19 are increasing among all ages. COVID-19 wastewater activity levels and model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in most states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.”
  • The University of Minnesota’s CIDRAP lets us know,
    • New survey data from the Centers for Disease Control and Prevention (CDC) shows that uptake of two vaccines routinely recommended for teens increased last year, while coverage with another recommended shot remained flat.
    • The data from the 2024 National Immunization Survey-Teen, published yesterday in Morbidity and Mortality Weekly Report, show that, among 16,325 US adolescents aged 13 to 17 years, coverage with more than one dose of the tetanus, diphtheria, and acellular pertussis (Tdap) vaccine increased from 89.0% in 2023 to 91.3% in 2024. Coverage with one or more dose of the quadrivalent (four-strain) meningococcal conjugate vaccine (MenACWY) rose from 88.4% to 90.1%.
    • Coverage with one or more Tdap dose was 90% or higher in 39 states, while coverage with one or more MenACWY dose was 90% or higher in 30 states. The survey also found that coverage with other recommended and catch-up vaccines increased in 2024, including the meningococcal group B vaccine (up 4.5 percentage point among 17-year-olds); the measles, mumps, and rubella vaccine (a 1.3-percentage-point increase in 13- to 17-year-olds with 2 or more doses); and the hepatitis B vaccine (a 1.3-percentage-point increase in teens with 3 or more doses).
    • “These findings highlight progress in public health activities to improve vaccination coverage,” CDC researchers wrote.
    • “Human papillomavirus (HPV) vaccine coverage among teens remained unchanged for the third straight year, however, with 78.2% having received one or more doses and 62.9% reporting they were up to date with the HPV vaccine. Coverage with one or more HPV vaccine doses was 80% or higher in 26 states and the District of Columbia.”
  • MedPage Today relates,
    • “Genetic susceptibility accounts for 20% of ovarian cancer risk, and risk-reducing bilateral salpingectomy remains the gold standard for prevention.
    • “In this study, about 24% of patients with high-grade serous ovarian cancer had missed opportunities for risk-reducing surgery before cancer diagnosis.
    • “Among the women with a first-degree family history of ovarian cancer, 43.2% had mutations that increased susceptibility to ovarian cancer.”
  • and
    • “A BMJ guideline put patient risk into the equation for assessing the suitability of SGLT-2 inhibitors and GLP-1 receptor agonist drugs for type 2 diabetes.
    • “Their use in type 2 diabetes was only strongly recommended for people at higher risk of cardiovascular and kidney complications.
    • “Meanwhile, these costly medications continue to be used more and more in the U.S. for a variety of indications.”
  • The AHA News points out,
    • “The American Heart Association and American College of Cardiology Aug. 14 released new guidelines on high blood pressure prevention, suggesting earlier treatment can reduce the risk of cognitive decline and dementia, as well as cardiovascular disease, stroke and kidney disease. The new guidelines replace those issued in 2017 and include new or updated recommendations for medication options and managing high blood pressure before, during and after pregnancy. The guidelines also reinforce the importance of healthy lifestyle behaviors such as eating a nutritious diet, being physically active, and maintaining or achieving a healthy weight.”
  • Per an NIH news release,
    • “Scientists at the National Institutes of Health (NIH) successfully reduced the severity of late-onset Tay-Sachs (LOTS) disease in human cell cultures and a mouse model by using a novel gene-editing treatment. LOTS is a rare form of Tay-Sachs disease, with signs and symptoms such as muscle weakness, loss of coordination, muscle spasms, and sometimes loss of mental function beginning in late childhood to adulthood. Similar disorders for which this breakthrough has implications include GM1 gangliosidosis, Sandhoff disease, Niemann-Pick disease, Krabbe disease and Gaucher disease.
    • “LOTS is a genetic disorder caused by a mutation in the HEXA gene that causes a deficiency of an enzyme that is critical to breaking down a fatty substance in the brain, known as GM2 ganglioside. The buildup of this fatty substance damages nerve cells in the brain and spinal cord. The amount of enzyme still being produced by the body affects the severity of the disease and the age of onset. By deploying the correction to the HEXA gene, scientists were able to increase the activity of the enzyme, known as beta-hexosaminidase A, delay symptom onset and significantly extend lifespan in the mouse model.
    • “With LOTS, a slight correction will go a long way. This editing may only need to increase enzyme activity by about 10% to keep symptoms from getting worse, and improve their quality of life,” said paper author Dr. Richard Proia of NIH’s National Institute of Diabetes and Digestive and Kidney Diseases. “We’ve figured out that opening the door to increased enzyme activity is possible, now we have to figure out how to do it in a person.”

From the U.S. healthcare business front,

  • Reuters reports,
    • “Shares of UnitedHealth Group (UNH.N), opens new tab surged nearly 14% on Friday after billionaire Warren Buffett’s Berkshire Hathaway (BRKa.N), opens new tab bought 5 million shares of the company, providing a shot in the arm for investors who think the health conglomerate will turn around under its new CEO.
    • “The shares have lost nearly half their value in the last year as the company struggled to adapt to rising healthcare costs and changes to government reimbursement plans that affected its health insurance and Optum patient care businesses.”
  • The Wall Street Journal relates,
    • “Nike co-founder Phil Knight and his wife, Penny Knight, are donating $2 billion to Oregon Health & Science University’s Knight Cancer Institute—the largest known single gift to a U.S. university, coming at a time when colleges’ public funding is under siege.
    • “The gift will roughly double the size of the cancer center, expanding its capacity to treat patients and conduct research. 
    • “The effort will be led by Dr. Brian Druker, a cancer-research pioneer known for developing Gleevec, a drug that transformed the survival of patients with chronic myeloid leukemia, a cancer of the blood and bone marrow. Druker, an OHSU professor who led the Knight Cancer Institute as chief executive officer until December, will return as the organization’s president. 
    • “We couldn’t be more excited about the transformational potential of this work for humanity,” the Knights said in a news release Thursday.”
  • Per Beckers Hospital Review,
    • “Hospitals and health systems are preparing for a rise in high-risk pregnancies, even as many labor and delivery units shut down. 
    • “Vizient company Sg2 projected that the proportion of high-risk pregnancies will accelerate alongside a rise in obesity-related comorbidities, including high blood pressure and diabetes. 
    • “Baptist Medical Center Jacksonville, part of Jacksonville, Fla.-based Baptist Health, is expanding its labor and delivery services in preparation for a 14.5% increase in high-risk pregnancies over the next decade, NPR affiliate WUSF reported Aug. 14. 
    • “The conundrum is this: Multiple health systems and hospitals are ending labor and delivery services, citing a decrease in birth rates, financial challenges and a workforce shortage. And although the national birth rate is declining, neonatal ICU admissions are increasing.
    • “There are a few factors contributing to the trend, including better survival rates of premature infants, an advancing maternal age and a rise in chronic maternal conditions. 
    • “In response to this trend, a different system of the same name, Little Rock, Ark.-based Baptist Health, announced in June an effort to improve maternal and children health outcomes for high-risk pregnancies. The initiative is Nashville, Tenn.-based Vanderbilt University’s Maternal Infant Health Outreach Worker Program, which targets economically disadvantaged and geographically isolated communities.” 
  • Per MedTech Dive,
    • “Oracle Health is releasing a new artificial intelligence-backed electronic health record, months after the technology giant first teased the “next generation” system.
    • “The EHR allows clinicians to use voice commands to access information, like a patient’s latest lab results or a list of current medications, cutting down the amount of time providers spend navigating through health records, the technology giant said in a press release Wednesday. 
    • “The AI-backed product is now available for ambulatory providers in the U.S., pending certification by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT, Bharat Sutariya, SVP and chief health officer at Oracle Health, told Healthcare Dive. Oracle plans to launch functionality for the acute care market in 2026.” 

Friday report

David Ermer–CDC, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, OPM, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Here is a link to OPM Director Scott Kupor’s latest blog post which is titled “Supporting Agencies through Change.” Thanks, Director Kupor for keeping us abreast of your activities.
  • The Wall Street Journal reports,
    • “President Trump removed former congressman Billy Long as the commissioner of the Internal Revenue Service after less than two months in the job.
    • “Long is being replaced on an interim basis by Treasury Secretary Scott Bessent, a senior White House official said. Bessent is the latest leader of a federal bureau that has gone through a series of commissioners since the start of Trump’s second term. Long was sworn in as the commissioner in June. 
    • “Long said Trump is appointing him as ambassador to Iceland.” 
  • The American Hospital Association News tells us,
    • “President Trump Aug. 7 issued an executive order, “Improving Oversight of Federal Grantmaking,” requiring government agencies to review new and discretionary grants to ensure grant funding advances the administration’s policy priorities. Among other provisions, the order restricts agencies from funding programs that “fund, promote, encourage, or facilitate: (A) racial preferences or other forms of racial discrimination … (B) denial by the grant recipient of the sex binary in humans … (C) illegal immigration; or (D) any other initiatives that compromise public safety or promote anti-American values.” The executive order also encourages agencies to award grants to institutions with lower indirect cost rates, to a broad range of recipients rather than repeat players, and to include clear benchmarks for measuring progress and success, as well as a commitment to Gold Standard Science. Within 30 days, agencies will update the terms and conditions for new and existing discretionary grants, which may permit immediate termination of existing grants.”
  • and
    • “The U.S. Departments of Labor, Health and Human Services, and the Treasury announced Aug. 7 that they are reconsidering the definition of short-term, limited-duration insurance through a formal rulemaking process. Until new rules are finalized, the departments will not prioritize enforcement actions against insurers that do not fully comply with the 2024 definition, including related notice requirements.
    • “HHS encourages states to adopt a similar enforcement approach and will not penalize states that either follow this federal approach or apply their definitions of STLDI under state law.”
  • STAT News informs us,
    • “Federal health officials are citing an extensive list of studies purported to document harms caused by messenger RNA vaccines as scientific justification for canceling hundreds of millions of dollars in investment in the technology. 
    • “Health secretary Robert F. Kennedy Jr. provided only a brief explanation for the decision earlier this week, arguing the mRNA vaccines are not effective and not as safe as alternatives, and referencing a review of scientific research on mRNA by “experts,” without identifying them. On Friday, when asked if the Department of Health and Human Services had a scientific justification, a spokesperson provided a link to a 181-page list of studies compiled by a number of people, including a current Trump administration adviser who served in the president’s first administration and was the subject of controversy for pushing unproven Covid-19 treatments. 
    • “The other contributors are people who have all previously criticized Covid-19 public health interventions, such as lockdowns and mRNA vaccines. 
    • “Taken together, the studies cited generally appear to advance research that has been disputed by other scientists, who argue that mRNA vaccines are overwhelmingly safe.”

From the Food and Drug Administration front,

  • MedPage Today relates,
    • “The FDA on Friday granted accelerated approval to zongertinib (Hernexeos) for non-squamous non-small cell lung cancer (NSCLC) patients harboring HER2 tyrosine kinase domain (TKD) activating mutations.
    • “Approval of the tyrosine kinase inhibitor stipulates use in adults with unresectable or metastatic disease who have received prior systemic therapy and was based on results from the open-label, phase Ia/Ib Beamion LUNG-1 study.”
  • Fierce Pharma adds,
    • “After telegraphing an investigation in November, the FDA has moved to restrict the use of bluebird bio’s gene therapy Skysona in certain patients.
    • “The FDA has updated Skysona’s indication, allowing it to be used only in patients who do not have an available human leukocyte antigen (HLA)-matched donor for stem cell transplant. The one-time therapy is approved to treat cerebral adrenoleukodystrophy (CALD), a rare inherited neurological disorder in which the accumulation of harmful fatty acids in the bloodstream damages the protective myelin sheath around nerve fibers.
    • “The FDA decided that Skysona should not be used in patients with alternative treatment options due to concerns of an increased risk of blood cancer.” * * *
    • “Skysona, with a list price of $3 million per treatment, recorded no sales in the first three months of 2025. Beta-thalassemia therapy Zynteglo saw its sales rise to $26.3 million during the first quarter, compared with $18.6 million a year ago. The sickle cell disease gene therapy Lyfgenia brought in $12.4 million in sales during the period, while Vertex’s rival CRISPR-based treatment Casgevy pulled in $14.2 million.” * * *
    • “As commercial progress of the three gene therapies fails to impress and a debt payment nears its due date, bluebird bio recently sold itself to Carlyle and SK Capital Partners for $49 million, or $5 per share, following some investor resistance to a previous lower offer price.”
  • Per an FDA news release,
    • “I [FDA Commissioner Marty Makary] am pleased to announce that the nationwide shortage of sodium chloride 0.9% injection products, a form of intravenous (IV) saline, has officially ended. This marks a significant milestone for public health and reinforces the FDA’s commitment to ensuring Americans have consistent access to life-saving medical products.” * * *
    • “For other IV fluids still in shortage, the FDA is working closely with manufacturers and will continue to monitor the supply to help ensure patients have access to the medicines they need. The availability of reliable medical products is essential to patient care and the overall resilience of our healthcare system. Addressing this shortage has been a top priority for the FDA and aligns with the Trump Administration’s broader commitment to strengthening the U.S. drug and medical supply chain.”
  • MedTech Dive lets us know,
    • “Boston Scientific has updated the instructions for use for products deployed in the implantation of its Watchman heart device to reduce a risk associated with 120 serious injuries and 17 deaths.
    • “The Food and Drug Administration released an early alert about the update Wednesday. Sharing information from Boston Scientific, the FDA said implanting the heart device without controlling the patient’s breathing increases the risk of an air bubble getting into the vascular system.
    • “Patients are only at risk during the implant procedure. People who have a previously implanted Watchman device do not need additional management.”

From the judicial front,

  • The Wall Street Journal reports,
    • “[The prescription drug manufacturer] GSK will receive $370 million from a U.S. patent settlement between CureVac and BioNTech regarding mRNA-based Covid-19 vaccines.
    • “GSK will get an upfront cash payment of $320 million and a 1% royalty on future U.S. sales of related mRNA vaccine products.
    • “The settlement does not affect GSK’s ongoing patent litigation against Pfizer and BioNTech in the U.S. or Europe.”
  • Healthcare Dive reports,
    • “Healthcare bankruptcies dropped to a three-year low during the second quarter of 2025, according to a new report from Gibbins Advisors. Just seven companies with at least $10 million in liabilities filed for Chapter 11 protections, compared with 14 in the same period last year.
    • “The restructuring advisory firm predicts there will be 16% fewer filings this year compared to 2024, as less large healthcare companies and providers declare bankruptcy.
    • “However, the dip may be short lived. Challenging market conditions, including impacts from cuts to Medicaid, could hit providers’ bottom lines as early as 2026, potentially spurring a new wave of bankruptcies, according to Gibbins.”

From the public health and medical research front,

  • The JAMA Network reports,
    • “Although the average life expectancy in the US remains lower than before the COVID-19 pandemic, 2023 marked the second consecutive year of improvement, according to a new report from the US Centers for Disease Control and Prevention (CDC). The authors attributed increases in life expectancy across all groups to decreased mortality from COVID-19, heart disease, unintentional injury, cancer, and diabetes.
    • “The overall average life expectancy rose by almost a year between 2022 and 2023, from 77.5 years to 78.4 years. During this period, male life expectancy increased from 74.8 to 75.8, whereas female life expectancy increased from 80.2 to 81.1. The average female life expectancy has exceeded that of males for decades, but the size of this gap continues to fluctuate.
    • “When analyzed by race and ethnicity, life expectancy increased for all populations in 2023. The American Indian and Alaska Native population experienced the greatest jump in mean life expectancy, a 2.3-year rise from 67.8 to 70.1.”
  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many areas of the country. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “COVID-19 laboratory percent positivity is increasing nationally. Emergency department visits for COVID-19 are increasing among all ages. COVID-19 wastewater activity levels and model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in most states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.”
  • The University of Minnesota CIDRAP adds,
    • “Amid a slow but steady rise in COVID activity, SARS-CoV-2 wastewater detections last week rose from the low to the moderate level, with the highest levels in the West, followed by the South, where detections in Louisiana are at the very high level, the US Centers for Disease Control and Prevention (CDC) said today in its latest weekly data updates. 
  • and
    • “Today in JAMA Network Open, University of Michigan-led research suggests that the US 2023-24 mRNA COVID-19 vaccines were cost-effective for people older than 65 years and in certain situations for younger adults.” * * *
  • and
    • “A survey conducted in emergency departments (EDs) in eight US cities found that 86% of adult respondents were not up to date with recommended vaccines, and half had not even heard of one or more of these vaccines.
    • “But the results of the survey, conducted by a team of US researchers and published yesterday in Morbidity and Mortality Weekly Report, also found that nearly half of the respondents said they would be willing to get a missing shot if they were offered one during their ED visit, and most of those participants said they’d be willing to get all of their missing vaccines.
    • “The authors of the study say the findings indicate that screening for vaccine coverage in EDs, which millions of Americans rely on as their only source of healthcare, could help boost recommended vaccine uptake in populations that have no primary care provider, such as immigrants, the uninsured, and homeless people.”
  • Per JAMA Network,
    • “The tau protein is known to be ubiquitous in neurons. Its naturally unfolded and highly flexible character allows it to interact with many components in neurons, especially microtubules in axons, helping to give these elements structure and promote growth. But when tau undergoes certain abnormal biochemical modifications such as phosphorylation, the pliable protein can lose function and can misfold and aggregate, leading to the development of neurofibrillary tangles and contributing to neurodegeneration. That’s why high levels of phosphorylated tau (p-tau) serve as one of the two main fluid biomarkers for Alzheimer disease (AD)—and why it surprised researchers when they recently discovered that infants have levels of p-tau far higher than people with AD.
    • “I was used to just hearing ‘p-tau is Alzheimer disease,’” said Fernando Gonzalez-Ortiz, MD, PhD, of the University of Gothenburg in Sweden who published the recent findings with a team of international collaborators. “In the Alzheimer disease field, we are sometimes very focused on thinking that p-tau is one of the bad guys, like tau phosphorylation is a completely pathological process, but that is not the case.”
    • “Using blood samples from umbilical cords and data from the Norwegian Dementia Disease Initiation cohort, Gonzalez-Ortiz and his colleagues found that healthy newborns had serum concentrations of p-tau217, an AD biomarker, around 10 pg/mL, nearly 3 times higher than those measured in patients with AD.
    • “The observation, which appeared this June in Brain Communications, led Gonzalez-Ortiz to a question: “What does it mean that the baby can handle these high concentrations of p-tau, but the adult brain can’t?” * * *
    • “Maybe in the future, therapies that target the clearance mechanisms and then enhance clearance, in combination with antiamyloid therapies, might lead to not only getting rid of amyloid, but also to preventing aggregation of tau,” Gonzalez-Ortiz said.
    • “His team’s next step is to differentiate the forms of p-tau present in the infant samples. Villain noted that it could also be useful to test the ratio between p-tau and total tau in the specimens to understand whether infants simply have more tau in their bloodstream.”
  • The University of Minnesota CIDRAP relates,
    • “A study of adults hospitalized with community-acquired pneumonia (CAP) in Georgia and Tennessee shows that a sizable fraction of infections was caused by Streptococcus pneumoniae, including serotypes covered by recently approved vaccines, researchers reported yesterday in JAMA Network Open.
    • “The prospective active-surveillance study, led by researchers at Vanderbilt University Medical Center, analyzed data on patients with clinical and radiologic evidence of CAP at three hospitals in Georgia and Tennessee from 2018 through 2022.” * * *
    • “The authors note that the annual incidence of 43 hospitalizations per 100,000 adults extrapolates to 114,800 US hospitalizations for pneumococcal CAP each year, based on current population estimates.
    • “Results of this study demonstrate that pneumococcal CAP remains an important cause of hospitalizations in the US,” they wrote. “With vaccination as the primary preventive measure for pneumococcal pneumonia, improved pneumococcal vaccines with appropriate vaccination coverage could lessen the burden of severe pneumonia on the US population, especially among older adults.” 
  • The Wall Street Journal reports,
    • “With a 33-year high in U.S. measles cases, researchers are reviving the search for treatments because of falling vaccination rates.
    • “Biotechs and universities are developing drugs for vulnerable, unvaccinated people.
    • “Monoclonal antibodies could offer immediate immunity, benefiting newborns, the immunocompromised and vaccine skeptics, scientists say.”
  • Per Health Day,
    • “Automatically mailing a stool test kit to people’s homes might be the best way to boost colon cancer screening among younger adults, a new study says.
    • “More 45- to 49-year-olds went ahead with cancer screening when they received an unsolicited stool test kit in the mail, rather than having to actively opt into screening or choose a test, researchers reported Aug. 4 in the Journal of the American Medical Association.
    • “Removing the need for patients to actively opt into screening can lead to better outcomes, particularly when trying to engage younger, generally healthy adults who may not yet perceive themselves at risk for cancer,” senior researcher Dr. Folasade May said in a news release. She’s a gastroenterologist and cancer prevention researcher at the UCLA Health Jonsson Comprehensive Cancer Center.”

From the U.S. healthcare business front,

  • Modern Healthcare interviews Debra Sukin, president and CEO of Texas Children’s, about the impressive financial turnaround at Texas Children’s, the largest pediatric hospital system in the U.S.
    • “How did you make a turnaround happen?
      • “We set out to best address the redesign of our organizational structure and realign the leadership team. We began to chart a course, entity by entity, department by department, in terms of how we were going to achieve our strategic goals.
      • “I’m a very data-driven leader. Organizing the way that we look at data, share data and use data to make decisions became absolutely paramount. We could easily see all our respective entities and where there were opportunities for improvements, and most importantly, identify how we were going to look beyond just expense management. 
      • “It was also about growth. It was about homing in on those opportunities and treating additional patients who needed our care.” 
  • Fierce Healthcare adds,
    • “Ascension [Healthcare, another large health system,] is taking a more intentional approach to innovations with a new unit dedicated to exploring, vetting and deploying tech tools across the major nonprofit health system.
    • “The organization announced this week the launch of its Clinical Innovation Institute (CII), which Ascension Chief Clinical Officer Thomas Aloia, M.D., describes as an “umbrella” aggregating and presiding over other innovation and tech programs that were already active within Ascension.
    • “We are absolutely not starting from scratch,” he said. “I would say we’re driving at about 60 miles per hour, and this organizational backing and support is going to take us to drive even faster.”
  • Healthcare Dive lets us know,
    • “Community Health Systems has found a new buyer for its three-hospital portfolio in Pennsylvania, approximately nine months after a proposed sale of the same facilities to WoodBridge Healthcare collapsed.
    • “Hospital turnaround firm Tenor Health Foundation signed a letter of intent to acquire Regional Hospital of Scranton, Moses Taylor Hospital and Wilkes-Barre General Hospital, collectively Commonwealth Health System, last week, a CHS spokesperson told Healthcare Dive. 
    • “The hospitals have been hemorrhaging money in recent fiscal years, according to reports filed to the Pennsylvania Health Care Cost Containment Council. Lawmakers have previously expressed worry that CHS could close the facilities if they could not find a buyer, reducing patients’ access to care.” 
  • Per Fierce Healthcare,
    • “In its first public earnings call after its initial public offering in June, virtual chronic disease provider Omada Health reported $61 million in revenue, up 49% year over year. The company has added 52% more members since Q2 2024 for a total of 752,000 members.
    • “Omada went public in early June, at a valuation of $1.1 billion, during what has turned out to be a worse-than-expected year for digital health exits due to economic uncertainty and tariffs. Hinge Health, a virtual MSK solution, also went public in May and reported its Q2 earnings on Wednesday.
    • “Omada ties remote monitoring devices with coaching and AI to help consumers control their chronic diseases. The company treats diabetes, hypertension, obesity and musculoskeletal conditions and leans on its multi-condition approach to differentiate itself from competitors.” 

Midweek report

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–
  • Fedsmith lets us know,
    • “The summer of 2025 experienced an unusually high surge in incoming retirement claims, starting in May and continuing into June. This surge can be largely attributed to the significant number of federal employees who have left federal service through various programs, including deferred resignation, Voluntary Early Retirement Authority (VERA), and others.
    • “According to OPM, approximately 154,000 federal employees have resigned under the deferred resignation program, and OPM Director Scott Kupor said recently that he anticipates the total federal workforce reduction to be at least double that number in the near future.”
  • Per an OPM press release,
    • The U.S. Office of Personnel Management (OPM) today announced that registration is now open for its innovative Executive Development Programs, designed specifically for Senior Executives Service (SES), GS-15, and GS-14 leaders.
    • These programs are closely aligned with President Trumpʼs new Executive Core Qualifications (ECQs) for senior executives, ensuring participants develop the critical competencies needed for todayʼs federal leadership roles.
    • By focusing on these updated standards, OPM is empowering leaders to deliver meaningful results and advance the mission of government agencies nationwide, drive President Trumpʼs ambitious agenda, and improve performance and accountability across the federal government. The program is highlighted by training videos from key Trump Administration leaders and distinguished career Senior Executives.
  • The American Hospital Association News tells us,
    • “A new analysis published Aug. 6 by the Peterson Center on Healthcare and KFF found that Health Insurance Marketplace insurers will propose a median premium increase of 18% for 2026. A previous analysis reported 15% based on preliminary findings. The new findings were examined from individual market filings, which provide additional details and are publicly available. The proposal more than doubles last year’s 7% median proposed increase.
    • “Insurers are citing the increase on higher prescription drug costs as well as labor costs, inflation, the scheduled expiration of enhanced premium tax credits and impacts from tariffs. The report found that the expiring tax credits would increase out-of-pocket premium payments by more than 75% on average, while tariffs could increase costs of certain drugs, medical equipment and supplies. Final rates will be determined in late summer.”
  • Bricker Graydon informs us,
    • “As employers increasingly struggle with rising health plan costs, the IRS has provided some good news.  Recently, the IRS announced that the Affordable Care Act (ACA) affordability threshold will increase to 9.96% of household income for plan years starting in 2026.  This is an increase from the 9.02% that applied to 2025.  This significant increase means employers have more room to potentially increase the employee portion of premiums for 2026. 
    • “The ACA affordability percentage is used to determine if ACA employer penalties may apply to employer-provided coverage. An employer’s health coverage will be considered affordable as long as the employee’s required contribution for the lowest-cost, self-only coverage does not exceed 9.96% of their income (or an IRS-approved safe harbor equivalent, such as the W-2, rate-of-pay, or federal poverty line methods). For example, under the federal poverty line safe harbor, monthly employee contributions will need to remain below approximately $129.89 in 2026.”

From the Food and Drug Administration front,

  • The University of Minnesota’s CIDRAP points out,
    • “Clarametyx Biosciences said this week that its investigational antibody treatment for cystic fibrosis patients plagued by chronic bacterial lung infections will receive priority review and development incentives from the US Food and Drug Administration (FDA).
    • “The company said in a press release that the FDA had granted CMTX-101, a monoclonal antibody designed to rapidly collapse bacterial biofilms, Fast Track and Qualified Infectious Disease Product (QIDP) designations under the Gaining Antibiotic Incentives Now Act. The two designations mean Ohio-based Clarametyx will get more frequent interactions with the agency, an expedited review process and potentially accelerated approval, and an additional 5 years of market exclusivity if CMTX-101 is approved.”
  • Cardiovascular Business reports,
    • “Boston Scientific’s Watchman device is associated with a heightened risk of air embolism events if the implant procedure is performed without positive pressure-controlled ventilation, according to the U.S. Food and Drug Administration (FDA). Air embolism is a rare, but potentially fatal complication that occurs when air enters the bloodstream and creates a blockage in a patient’s blood vessel. 
    • “According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk of negative left atrium pressure and air ingress,” according to a new FDA advisory. “This risk is especially prevalent in patients with preexisting low left atrial pressure, hypovolemia and partial upper airway collapse.”
    • “The FDA emphasized that air embolism can lead to “severe outcomes, including life-threatening or fatal consequences.” 
    • “Because of this risk, which has been associated with 120 serious injuries and 17 deaths as of July 30, Boston Scientific is updating the assembly instructions of several access systems used to implant the Watchman device in patients with nonvalvular atrial fibrillation.”
  • and 
    • “The U.S. Food and Drug Administration (FDA) is sharing additional details about a safety issue with certain Boston Scientific defibrillation leads. 
    • “According to the agency, some of the company’s single- and double-coil Reliance defibrillation leads coated with expanded polytetrafluoroethylene (ePTFE) have been associated with a potential risk of rising low-voltage shock impedance (LVSI). This issue, linked to calcification, may make the devices less effective as time goes on.
    • “The most common harm is early lead replacement, and the most serious harm is death or need for cardiac resuscitation due to non-conversion of a sustained ventricular arrhythmia from a reduced shock energy due to high impedance,” according a new FDA advisory. “As of July 24, Boston Scientific has reported 386 serious injuries and 16 patient deaths associated with this issue.”
    • “The FDA is still reviewing the situation. At this time, the agency has not determined if this is a Class I recall. The goal of this early alert is to provide details as quickly as possible.” 

From the judicial front,

  • MedTech Dive relates,
    • “The Federal Trade Commission has moved to block Edwards Lifesciences’ planned acquisition of JenaValve Technology, citing concerns that the deal threatens to reduce competition in the market for devices to treat aortic regurgitation.
    • “The agency alleged that over two days in July 2024, Edwards signed agreements to acquire both JenaValve and JC Medical, the two leading companies competing to bring transcatheter aortic valve replacement devices to market to treat the potentially fatal heart condition. Edwards closed the acquisition of JC Medical in August 2024.
    • “The FTC said Edwards’ proposed $945 million acquisition of JenaValve would combine the only two companies conducting U.S. clinical trials for a TAVR aortic regurgitation, or TAVR-AR, device.
    • “The deal threatens to reduce competition in the TAVR-AR market, likely resulting in reduced innovation, diminished product quality, and potentially increased prices for consumers,” the agency stated in a federal court complaint.
    • “The commission voted 3-0 to issue an administrative complaint and seek a temporary restraining order and a preliminary injunction to halt the transaction pending an administrative proceeding. The complaint and injunction request were filed in the U.S. District Court for the District of Columbia.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP relates,
    • “In a weekly update today, the US Centers for Disease Control and Prevention (CDC) reported 23 more measles cases, bringing the national total for the year to 1,356 cases, the most since the United States achieved measles elimination in 2000.
    • “One more state reported cases, Wisconsin, lifting the number of affected states to 41. Three more outbreaks were reported, putting the nation’s total at 32 for the year. For comparison, the country had 16 outbreaks for all of 2024. 
    • “Of confirmed illnesses this year, 87% were part of outbreaks, compared with 69% for 2024. And of infected patients, 92% were unvaccinated or had unknown vaccination status. Though about 65% of cases occurred in children, 34% were recorded in adults ages 20 years and older.”
  • NBC News reports,
    • “A second person has now died and more than 50 people have fallen ill as part of a growing Legionnaires’ cluster in Harlem, city health officials reported Monday.
    • “The disease was initially detected on July 25; since then, two people have died and 58 people have been diagnosed, the New York City Health Department revealed in its latest update.
    • “Legionnaire’s, a type of pneumonia, is caused by the bacteria Legionella, which grows in warm water. The cases from the cluster have been found in five Harlem ZIP codes: 10027, 10030, 10035, 10037 and 10039, along with the bordering communities, according to health officials.
    • “If you’re in those ZIP codes that have demonstrated exposure, then we want you to monitor your symptoms and get to a healthcare provider as soon as you can so you can get access to antibiotics, because it is treatable,” said Dr. Tony Eyssallenne, the deputy chief medical officer for the city’s Health Department.”
  • STAT News notes,
    • “Hundreds of wildfires burning across the Canadian provinces of Manitoba and Saskatchewan are pushing smoke across Canada and the American northeast. Canadian towns close to the wildfires are experiencing the worst of the smoke pollution, but even here in Boston, there was a brief ground stop at the airport Monday due to smoke and haze. 
    • “It’s getting better, but here’s a reminder: 
      • “Wildfire smoke is particularly harmful to kids’ respiratory health. One study found that a 10-unit increase of fine particulate matter from wildfire smoke was associated with a 30% spike in pediatric admissions for respiratory problems. “It’s quite a big bit of a difference,” the lead author said.
      • “Researchers have found that people who live in areas with high levels of fine particulate matter could have a greater risk of developing dementia, with a particularly strong link seen between the condition and exposure to wildfire emissions. Still, there are a lot of questions remaining about other long-term effects.
      • “In California, between 2008 and 2010, somewhere between 52,480 and 55,710 people died prematurely due to chronic exposure to wildfire smoke. The economic impact of those deaths was at least $432 billion.”
  • Per the AHA News,
    • “The Centers for Disease Control and Prevention Aug. 5 announced a new campaign educating youth ages 12-17 on substance use, mental health and how they are connected. The campaign includes facts about drugs, including prescription medications, and how they can lead to addiction and other health problems. It also includes tips and resources to help improve mental health and recognize the link between mental health and substance use.”
  • The Washington Post reports,
    • “Seven years of investigation by scientists at Harvard Medical School has revealed that the loss of the metal lithium plays a powerful role in Alzheimer’s disease, a finding that could lead to earlier detection, new treatments and a broader understanding of how the brain ages.
    • “Researchers led by Bruce A. Yankner, a professor of genetics and neurology at Harvard Medical School, reported that they were able to reverse the disease in mice and restore brain function with small amounts of the compound lithium orotate, enough to mimic the metal’s natural level in the brain. Their study appeared Wednesday in the journal Nature.
    • “The obvious impact is that because lithium orotate is dirt cheap, hopefully we will get rigorous, randomized trials testing this very, very quickly,” said Matt Kaeberlein, former director of the Healthy Aging and Longevity Research Institute at the University of Washington, who did not participate in the study. “And I would say that it will be an embarrassment to the Alzheimer’s clinical community if that doesn’t happen right away.”
    • “Yankner, who is also the co-director of the Paul F. Glenn Center for Biology of Aging Research at Harvard, said: “I do not recommend that people take lithium at this point, because it has not been validated as a treatment in humans. We always have to be cautious because things can change as you go from mice to humans.” He added that the findings still need to be validated by other labs.”
  • Per MedPage Today,
    • “Most therapies for low back pain provide only short-term relief; it’s unclear, however, whether benefits from cognitive functional therapy (CFT) may last longer.
    • “Investigators in this study performed 3-year follow-up with participants in a 6-month trial of CFT versus usual care.
    • “Compared with usual care, patients receiving CFT either with or without biofeedback for 6 months continued to show more improvement after 3 years.”
  • Per Beckers Hospital Review,
    • “Healthcare experts are calling for the end of routine use of diphenhydramine, the active ingredient in a common allergy medication, sold as Benadryl, citing safety concerns that outweigh benefits, CNN reported Aug. 1. 
    • “It’s time to move on. For every single indication that people are using diphenhydramine, there are better drugs that are more effective at treating the symptoms people are trying to treat with fewer side effects,” said Anna Wolfsen, MD, an allergist at Massachusetts General Hospital in Boston. “I’ve had patients where I worried that diphenhydramine was impairing their ability to drive or fully participate in their daily lives.”
    • “The widely used, first-generation antihistamine is commonly used to treat allergies. However, other second-generation antihistamines, including brand names such as Claritin, Zyrtec and Allegra, offer the same or better relief with fewer side effects, experts told CNN.” 

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Hinge Health beat investor expectations on revenue in the digital musculoskeletal care company’s first public earnings results.
    • “Revenue increased 55% year over year to $139.1 million in the second quarter, the firm said in earnings released Tuesday. 
    • “The digital health company reported an operational loss of $580.7 million, compared with $17.6 million last year, driven by a stock-based compensation expense largely related to Hinge’s recent IPO, a spokesperson told Healthcare Dive.”
  • STAT News tells us,
    • “Exact Sciences announced on Wednesday that it acquired the rights to a blood-based colon cancer screening test from rival firm Freenome.
    • “Exact is paying Freenome $75 million for exclusive rights in the United States to current and future versions of the Bay Area company’s test, which is currently under review by the Food and Drug Administration. Freenome is eligible for up to $700 million in additional milestone payments.
    • “The deal ratchets up Exact’s intense competition with Guardant Health, which received FDA approval last year for its own blood-based colon cancer test.
    • “Exact had been developing its own blood-based colon cancer test. Last year, the company reported promising initial results from a study of more than 3,000 samples. But on Wednesday, the company disclosed that additional testing showed that the liquid biopsy test wasn’t quite accurate enough to win Medicare reimbursement. Instead, Exact will now look to market Freenome’s test to patients, pending approval.” 
  • Per Fierce Healthcare,
    • “Days after decreasing full-year guidance by about half a billion dollars, Oscar Health missed earnings projections for the second quarter.
    • “The insurer posted a higher-than-anticipated loss per share of 89 cents, according to estimates by FactSet, reported Sherwood News.
    • “Oscar also recorded a net loss of $228 million, one quarter after having a net profit of $275 million. The insurer saw quarterly revenues hit $2.86 billion and its medical loss ratio (MLR) climb to 91.1%.
    • “The stark jump from a MLR of 79% was due to an increase in market morbidity in the Affordable Care Act exchanges, leading to a net risk adjustment transfer accrual, CEO Mark Bertolini told investors.”
  • and
    • “Blue Shield of California is teaming up with Gemini Health to roll out a new member tool that offers greater transparency at the pharmacy counter.
    • “The tool, called Price Check My Rx, will be available in the insurer’s existing member app, allowing members to see in real time the out-of-pocket price for any new or refilled prescriptions submitted by their provider and covered under their pharmacy benefits.
    • “When the prescription is submitted electronically, the platform will send the member a push notification that prompts them to look at the pricing details and explore alternatives, including low-cost options, if they prefer. Jigar Shah, chief marketing and strategy officer for Blue Shield, told Fierce Healthcare that the tool fits within the payer’s broader goal of simplifying the patient experience.”
  • The Wall Street Journal reports,
    • “Novo Nordisk’s Wegovy sales jumped 67% in the second quarter, despite generic competition in the U.S. market.
    • “The company reduced its full-year guidance due to the impact of copycat versions of its diabetes and obesity drugs.
    • “Outgoing CEO Lars Fruergaard Jorgensen expressed confidence in future growth under incoming CEO Maziar Mike Doustdar.”
  • BioPharma Dive adds,
    • “Scientists at Nxera Pharma have worked for the past year to develop a pipeline of wholly owned obesity drug candidates that the Tokyo and Cambridge, U.K.-based pharmaceutical company unveiled Wednesday. Chief among the seven new programs is an oral GLP-1 agonist that Nxera says is based on “differentiated chemistry” and is distinct from a compound it discovered together with Pfizer under a research alliance. Coincidentally, Pfizer disclosed Tuesday it discontinued development of that compound, a decision Nxera said was made “due to a portfolio decision.” 
  • Per MedTech Dive,
    • “BD is investing more than $35 million to expand production of prefilled flush syringes at a facility in Columbus, Nebraska, the company said Monday.
    • “The investment will add around 50 jobs at the site and equip BD to make hundreds of millions of additional units a year to meet growing demand from U.S. hospitals and health systems.
    • “BD framed the spending as part of an ongoing commitment to its Posiflush line, which has seen it invest more than $80 million to expand production of the syringes over the past three years.”

Midweek report

David Ermer–FDA, HSA, Medical / Rx research, Medicare, NIH, OPM, Patient safety, U.S. Healthcare–
  • Fedscoop interviews the new OPM Director Scott Kupor.
  • Kevin Moss, writing in Govexec, discusses how to avoid Medicare Part B late enrollment penalties.
  • The Wall Street Journal informs us,
    • “A Trump administration effort to block all funding that flows to outside health researchers was scrapped Tuesday evening after senior White House officials intervened, people familiar with the matter said. The funds—billions of dollars to study diabetes, cancer and more—are set to flow again, the people said.”
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services July 30 announced the creation of a “digital health ecosystem” that includes partnerships with health care organizations and technology companies, including Amazon, Anthropic, Apple, Google, and OpenAI. The initiative includes an interoperability framework with a goal of making health information easier to share between patients and providers. During an event at the White House, CMS announced voluntary criteria for data exchange to make data more accessible for health information networks and exchanges, electronic health records and technology platforms. More than 60 companies, including networks, payers, providers and app vendors signed pledges for the interoperability framework and agreed to meet certain objectives in the first quarter of 2026. The initiative will use secure digital identity credentials to obtain medical records from CMS-aligned networks that meet the agency’s data sharing criteria. Applications will be used to assist in delivering services such as diabetes and obesity management, conversational AI assistants and tools to replace paper intake forms with digital check-in methods.” 
  • Beckers Clinical Leadership points out four things to know about “a July report from HHS’ Office of Inspector General [concluding that’ hospitals failed to capture 49% of patient harm events because staff either did not consider them harmful or were not required to disclose them.”
  • BenefitsFocus shares HSA/HDHP trend identified by Benefitfocus’ 2025 Report.
    • “Benefitfocus found that Gen Z workers had the highest HSA-eligible HDHP participation relative to Millennials, Gen Xers, and Baby Boomers, and while overall participation in HDHP plans dipped slightly across all generations in 2025, Benefitfocus’ data showed that HSA-eligible HDHP participation increased among Gen Zers at a greater clip compared to Millennials, Gen Xers, and Baby Boomers from 2024 to 2025. 
    • “Benefitfocus also found that Gen Z workers had the lowest health care utilization. This makes some sense considering the fact that Gen Z are younger, and it’s likely that the younger you are, the less health care you may need to utilize. 
    • “However, Benefitfocus suggests that Gen Zers are under-utilizing health care because there is a gap in understanding (1) the benefits that are available to them, and also, (2) the various engagement tools that can help them access these benefits. 
    • “To this latter point, there are various tools and different programs that employers can deploy (1) to “engage” Gen Zers and (2) to better help Gen Zers understand that accessing high-value, cost-effective health care services (like preventive care, Telehealth services, and also Direct Primary Care services) is available to them for both short-term and long-term health needs.” 
  • Route 50 informs us,
    • “The Federal Communications Commission voted last week to require text messages to the 988 suicide and mental health crisis hotline to be georouted to local crisis centers based on where they are sent from.
    • “Previously, texts to 988, also known as Lifeline, had been routed to crisis centers based on the area code of the texter’s phone number. Mental health and crisis counseling experts had long warned the FCC that the discrepancy could limit Lifeline’s ability to connect those in crisis with local resources.”

From the Food and Drug Administration front,

  • Fierce Healthcare notes,
    • “Following the departure of Vinay Prasad, M.D., former head of the Center for Biologics Evaluation and Research (CBER), the FDA has already tapped someone else to temporarily fill his shoes.
    • “Freshly appointed Center for Drug Evaluation and Research (CDER) leader George Tidmarsh M.D., Ph.D., will now take on the role of acting director of CBER as well, according to an internal letter from FDA Commissioner Marty Makary, M.D., to staffers that was viewed by Fierce.
    • “Both departments fall under the FDA’s umbrella, with CDER covering most small-molecule and biological therapeutics while CBER oversees vaccines, cell and gene therapies and other blood products.”
    • “Tidmarsh is a veteran biotech executive who stepped into his federal leadership role at the beginning of last week.”

From the public health and medical research front,

  • STAT News reports,
    • “After patients go into remission, there may still be undetected cancer cells lying dormant through the body. Years or even decades after remission, these cells might activate and cause metastatic lesions in these patients. Certain respiratory infections, including the flu and Covid-19, may be among the triggers for this awakening, according to a new study.
    • “The study, which combined mouse experiments and epidemiological data, focused on breast cancer and was published Wednesday in Nature. It found the immune system’s response to viral infections in the lungs might be contributing to this cancer cell activation. The epidemiological analyses also found that patients in breast cancer remission were more likely to develop lung metastases if they tested positive for Covid.
    • “Taken together, experts told STAT that the findings reveal new insights on how metastatic disease occurs, although they also cautioned that the findings are early and may not yet be generalizable to all cancer types or even all subtypes of breast cancer.
    • “It’s an exciting link between acute infections and a reactivation of these dormant cells that can lead to cancer progression,” John Alcorn, an immunology professor at the University of Pittsburgh who was not involved in the study, told STAT. “Something that we once thought of as a two-week problem really has far-reaching effects beyond that.”
  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have shown for the first time that a type of human papillomavirus (HPV) commonly found on the skin can directly cause a form of skin cancer called cutaneous squamous cell carcinoma (cSCC) when certain immune cells malfunction. cSCC is one of the most common cancers in the United States and worldwide. Previously, scientists believed HPV merely facilitated the accumulation of DNA mutations caused by ultraviolet (UV) radiation, usually the primary driver of cSCC. The findings were published today in The New England Journal of Medicine.
    • “This discovery could completely change how we think about the development, and consequently the treatment, of cSCC in people who have a health condition that compromises immune function,” said Andrea Lisco, M.D., Ph.D., of NIH’s National Institute of Allergy and Infectious Diseases (NIAID). “It suggests that there may be more people out there with aggressive forms of cSCC who have an underlying immune defect and could benefit from treatments targeting the immune system.”
    • “There are many different types of HPV, each tending to infect cells in a particular tissue and part of the body. The types of HPV found mostly on the skin—beta-HPV—are considered benign members of the skin microbiome that typically do not integrate into the DNA of skin cells. This contrasts with the alpha types of HPV, known to integrate into the DNA of mucous membrane cells and directly cause cancer of the genitals, anus, head and neck.”
  • The National Institute of Standards and Technology’s Taking Measure blog explains “How Nature’s Symmetry Might Help Us See Early Warning Signs of Cancer.”
  • Health Day reports,
    • “A dementia diagnosis typically arrives more than three years after the onset of symptoms
    • “That time lag jumps to an average of more than four years for folks battling early-onset dementias
    • “As drugs to fight dementias emerge, spotting the disease early will be crucial, researchers say.”
  • Also per STAT News,
    • “The decades-long push to develop an HIV vaccine has been riddled with setbacks. But researchers reported on Wednesday that they have managed to circumvent one of the longstanding challenges to developing protective shots against this complex and crafty virus.
    • “Scientists used a messenger RNA-based vaccine to reliably trigger antibodies that block viral infection in people and monkeys. The key, they found, was to use a vaccine that hid a portion of a key protein complex that pokes out of HIV’s surface, concealing a region that usually distracts the immune system from mounting a protective response. Only 4% of participants given a vaccine that exposed this part of the viral surface produced antibodies that could block infection; that jumped to 80% when this region wasn’t visible to the immune system.
    • “While researchers found that the vaccines they tested were generally safe and well tolerated, 6.5% of study participants developed hives, a finding also seen in another mRNA-based HIV vaccine study. These cases improved when participants took antihistamines, but scientists are looking into why this happened and how to avoid it.
    • “The findings were described in a pair of papers published in Science Translational Medicine. The authors note that this is the first time an HIV vaccine candidate has sparked antibodies that can neutralize infection in a large percentage of subjects.”
  • Per Medical Economics,
    • “Teens who regularly use e-cigarettes are just as likely to become cigarette smokers as their peers were in the 1970s, according to a new study co-led by researchers at the University of Michigan.
    • “The findings, published in the journal Tobacco Control, come despite dramatic declines in overall teen cigarette use over the last five decades. The study, a collaboration between the University of Michigan, Penn State University, and Purdue University, reveals that teenagers who had never used e-cigarettes had less than a 1-in-50 chance of smoking cigarettes weekly. In contrast, those who had tried e-cigarettes faced more than a 1-in-10 chance, while consistent e-cigarette users had nearly a 1-in-3 chance of also reporting cigarette use.
    • “The use of e-cigarettes and the proliferation of e-cigarettes have really disrupted those awesome trends and improvements,” said Jessica Mongilio, research fellow at the U-M School of Nursing and one of the study’s lead researchers. “For kids who have never used e-cigarettes, we do see those historic declines in risk. But for kids who do use e-cigarettes, it’s almost as if all of those policies and all of those perceptions have done nothing, and they’ve got a really high risk of smoking cigarettes.”
  • The Wall Street Journal reports,
    • “The use of ultrapotent synthetic opioids called nitazenes are spreading in Europe.
    • “Nitazenes, often from China, are mixed into heroin and other drugs. Even trace amounts can cause fatal overdoses, authorities warn.
    • “The U.S. has seen nitazenes in drug seizures, and the DEA warns Mexican cartels could use their relations with China-based suppliers to obtain nitazenes.” * * *
    • “The most common street nitazenes are roughly 50 to 250 times as potent as heroin, or up to five times the strength of fentanyl. They are likely much more prevalent than official statistics suggest, due to limited testing. Authorities say official death tolls are almost certainly undercounts.”

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Humana raised its 2025 guidance alongside the release of second quarter results that beat analyst expectations on Wednesday. It’s a bright spot for investors in the health insurance sector following dismal reports from other payers.
    • “Executives attributed the outperformance to higher-than-anticipated prescription volumes and more lucrative drugs dispensed in Humana’s pharmacy services division. The company also benefited from higher revenue in its insurance segment from unexpectedly strong Medicare Advantage membership retention.
    • “In addition, medical costs — though elevated — remained generally in line with what Humana had planned for coming into 2025, the company said. Humana’s stock was up 6% in Wednesday morning trading following the results.”
  • and
    • “Certain Universal Health Services growth targets for 2025 are looking less achievable after the for-profit health system reported another quarter of lackluster admissions on Monday.
    • “Behavioral health volumes in the second quarter were essentially flat, with adjusted admissions rising just 0.4%. It’s an improvement from last quarter, when behavioral health volumes declined. However, executives now consider UHS’ plans to grow adjusted behavioral patient days by 2.5% to 3% a long-term target, instead of a 2025 goal.
    • “CEO Marc Miller said one of the reasons UHS’ patient day target has remained “elusive” is payers’ growing preference for outpatient care, a trend that hasn’t favored UHS’ inpatient-heavy portfolio. To be competitive in the long term, UHS plans to focus capital spending on outpatient projects, building 10 to 15 freestanding behavioral health facilities per year.”
  • Fierce Healthcare points out,
    • “Teladoc Health announced its second-quarter earnings Tuesday, which revealed a 2% decline in revenue for the company. The company performed roughly 1% better than Wall Street analysts anticipated. 
    • “Teladoc reported $631.9 million in total revenue for the quarter that ended June 30, and a net loss of $32.7 million, or $0.19 per share. In the same quarter a year ago, the company posted a net loss of $838 million after it was hit with a $790 million goodwill impairment charge related to its virtual mental health offering, BetterHelp.
    • “Teladoc’s adjusted EBITDA margin was $69.3 million, down 23% year over year. Citigroup, Goldman Sachs Group, Bank of America and Truist Financial reduced their target prices for Teladoc in early July, MarketBeat noted.
    • “The integrated care portion of the business was the lone division with upside in the second-quarter earnings results. Integrated care brought in $391.5 million, up 4% compared to the same period last year. Its adjusted EBITDA margin was 14.7%.
    • “BetterHelp garnered $240.4 million in revenue, down 9% year over year. The tele-mental health brand had an adjusted EBITDA margin of 4.9%.” 
  • Beckers Hospital Review notes “Where hospital margins are climbing [and] dropping the most.”
    • “Margin growth or decline varied by region and hospital size. Here is the breakdown:
      • “South: 6.1 percentage points
      • “Midwest: 2.5 percentage points
      • “Northeast: 1.6 percentage points
      • “West: -2.2 percentage points
      • “0 to 25 beds: -1 percentage points
      • “100 to 199 beds: 4.2 percentage points
      • “300 to 400 beds: 0.8 percentage points
      • “500 or more beds: -0.2 percentage points’
  • The Wall Street Journal Bankruptcy Pro publication reports on “Hospital Failures Following Private-Equity Payouts Leave Patients, Taxpayers in Lurch. Communities where Steward Health Care and Prospect Medical had hospitals that closed are trying to fill gaps in healthcare and government budgets.”
  • WTW consulting’s Pulse offers the latest news on GLP-1 drugs.
    • “Utilization will continue to rise. A robust pipeline of new GLP-1 drugs later this year and in 2026 will bring more competition with the potential to drive lower unit costs.
    • “Government price negotiations for Medicare Part D plans could also put downward pressure on GLP-1 drugs in the commercial market.
    • “The drugs will likely gain other uses this year including metabolic dysfunction associated steatohepatitis, heart failure and peripheral artery disease, which will also contribute to more utilization.”

Monday report

David Ermer–CDC, CMS, FDA, Generative AI, Medical / Rx research, Medicare, NIH, Obesity, Patient safety, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Medicare drug plan premiums are expected to rise significantly next year due to rising costs and regulatory changes.
    • “A subsidy program that shielded seniors from rising monthly bills will be cut by about 40% in 2026.
    • “The premium increase will affect millions of seniors and may push more enrollees into Medicare Advantage plans.”
  • KFF tells us,
    • “Two new KFF analyses examine the latest data about Medicare Advantage, including trends in enrollment, premiums, out-of-pocket limits, supplemental benefits and prior authorization.
    • “The first analysis, focusing on enrollment trends, finds that 54% of eligible Medicare beneficiaries are enrolled in Medicare Advantage in 2025, though increases in enrollment slowed this year. One in five Medicare Advantage enrollees is in a special needs plan (SNP), reflecting a steady increase in recent years. And Medicare Advantage enrollment remains highly concentrated among a handful of insurance companies. 
    • “The second analysis finds that more than three quarters (76%) of enrollees in individual Medicare Advantage plans with prescription drug coverage pay no premium other than the Medicare Part B premium. The share of enrollees in plans offering a rebate against the Part B premium rose sharply from 12% in 2024 to 32% in 2025, but among these enrollees, about half are in plans that offer rebates of less than $10 a month while fewer (36%) are in plans that offer rebates of $50 or more per month. Prior authorization is most often required for expensive services such as skilled nursing facility stays (99%), Part B drugs (98%), inpatient hospital stays (acute: 96%; psychiatric: 93%) and outpatient psychiatric services (80%).” 
  • STAT News reports,
    • “No decision has been made on the future of an advisory panel [the U.S. Preventive Services Task Force] that decides which preventive care offerings, like cancer screenings, must be covered by insurers, a federal health department spokesperson said, after a [Wall Street Journal] report that health secretary Robert F. Kennedy Jr. is planning to oust all members. 
    • “But the report has alarmed the American Medical Association, which is calling on Kennedy to keep the panel’s members in place.” 
  • Modern Healthcare informs us,
    • “The Centers for Medicare and Medicaid Services wants to take another crack at creating a national provider directory in an effort to replace insurance company lists that are often riddled with errors.
    • “Health and Human Services Secretary Robert F. Kennedy Jr. and CMS Administrator Dr. Mehmet Oz touted the idea at a meeting with health information technology executives in June. In a later post on the social media platform X, CMS described its goal as a “dynamic, interoperable directory that connects the data CMS has with what the industry knows, so we all work from the same map.” * * *
    • “The insurance industry would support a national provider directory “grounded in a robust public-private partnership,” the trade group AHIP said in a statement. At the AHIP 2025 conference last month, executives from Centene, Cigna and Aetna parent company CVS Health said their companies have met with CMS to discuss the concept.”
  • and
    • “Top Trump administration health officials are expected to bring tech companies to the White House this week to roll out a plan to encourage more seamless sharing of healthcare data, according to people familiar with the matter.
    • “Health and Human Services Secretary Robert F. Kennedy Jr. and Centers for Medicare and Medicaid Services Administrator Mehmet Oz are expected to host executives at an event on Wednesday, said the people, who did not provide names of the attendees and asked not to be named because the details haven’t been made public.
    • “The plan was developed in coordination with the White House, building on a May effort by CMS to get public input on addressing barriers to sharing patient data.”
  • The American Hospital Association lets us know,
    • “The Substance Abuse and Mental Health Services Administration July 28 released its latest national survey on drug use and mental health. Among the findings, the percentage of adolescents aged 12 to 17 who had serious thoughts of suicide declined from 12.9% in 2021 to 10.1% in 2024. It also found a decline in adolescents who experienced a major depressive episode, dropping from 20.8% in 2021 to 15.4% in 2024. The survey also found that among the 61.5 million adults aged 18 or older in 2024 with any mental illness, 52.1% (32 million) received any mental health treatment in the past year. Among 14.6 million adults with serious mental illness in the past year, 70.8% (10.3 million) received mental health treatment. Due to changes to the survey questions and approach, not all estimates in the 2024 survey are comparable with 2023 and 2022 estimates, SAMHSA notes.” 
  • An HHS news release adds,
    • “The U.S. Department of Health and Human Services (HHS) has announced a $100M pilot funding opportunity to prevent, test for, treat, and cure Hepatitis C (HCV) in individuals with substance use disorder (SUD) and/or serious mental illness (SMI). This program is designed to support communities severely affected by homelessness and to gain insights on effective ways to identify patients, complete treatment, cure infections, and reduce reinfection by Hepatitis C (a liver disease caused by the Hepatitis C virus).
    • “HHS is delivering on our promise to the American people for a healthier, brighter future,” said HHS Secretary Robert F. Kennedy, Jr. “Through this pilot program, we are launching a comprehensive, integrated care model that not only cures HCV but also tackles critical risk factors like substance use, mental health challenges, and homelessness head-on.”
  • Beckers Hospital Review highlights five things to know about the foreign trade deals that the Trump administration has recently struck.

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has given Sarepta Therapeutics a green light to resume shipping its gene therapy Elevidys to some patients with Duchenne muscular dystrophy, a little over one week after demanding the company halt sales over safety concerns. 
    • “In a statement Monday evening, Sarepta said it would begin shipments to treatment sites “imminently.” The resumption applies only to Duchenne patients who can still walk, which typically describes individuals who are younger and whose disease hasn’t advanced as far.”
  • and
    • “The Food and Drug Administration has delayed its review of a Bayer therapy for hot flashes related to menopause, telling the drugmaker it needs additional to review the company’s application.
    • “In a Friday statement, Bayer said the FDA did not raise any concerns around “general approvability” of the drug, called elinzanetant. Still, the agency extended its decision deadline by three months.”
  • Per MedTech Dive,
    • “Johnson & Johnson’s Ethicon unit has corrected disposable surgical stapler cartridges over a fault related to one death and one injury, the Food and Drug Administration said Friday.
    • “The company wrote to customers in April after learning that devices may activate but not cut or staple tissue. Additional steps are needed to open and remove locked devices from tissue. 
    • “Ethicon designed the stapler to prevent lockout events from harming patients. Still, the FDA said the lockout problem could cause life-threatening hemorrhage, surgical delay and death.”

From the public health and medical research front,

  • The New York Times reports,
    • “A combination of healthy activities including exercise, nutritious diet, computer brain games and socializing can improve cognitive performance in people at risk for dementia, according to a large new study.
    • “The study, conducted in five locations across the United States over two years, is the biggest randomized trial to examine whether healthy behaviors protect brain health.
    • “It confirms that paying attention to things like physical activity and vascular risk factors and diet are all really important ways to maintain brain health,” said Dr. Kristine Yaffe, an expert in cognitive aging at the University of California, San Francisco, who was not involved in the study.
    • “The results were presented on Monday at the Alzheimer’s Association International Conference in Toronto and published in the journal JAMA.”
  • The Washington Post adds,
    • “Any amount of walking is good for your health but picking up the pace has significant benefits — and it’s never too late for someone to train to walk faster.
    • “In an analysis published in PLOS One earlier this month, researchers found that frail older adults who deliberately walked faster saw a meaningful improvement in the distance they could travel when instructed to walk for six minutes straight. (Frailty is an age-related syndrome that affects 5 to 17 percent of older adults and is characterized by fatigue, a loss of strength and unexplained weight loss.)
    • “The results show that regardless of your age, the intensity of your workout can lead to greater improvements in physical function, said Daniel Rubin, the lead author of the analysis and an associate professor of anesthesia and critical care at the University of Chicago.”
  • Per the National Academy of Medicine,
    • “With more than half a million people globally living beyond the age of 100, it is time to rethink how health professionals and educators view older adults and the aging process. “Redefining aging” begins with transforming the mindset of current and future health professionals through targeted education. This involves encouraging them to reconsider how they address the unique needs of older adults and identifying those who can drive this change. Educators, health professionals, administrators, and policymakers must collaborate to reshape systems and attitudes. Together, they can build a well‑trained workforce that is not only prepared but motivated to address the complexities of aging that may include chronic disease and functional decline but also opportunities for growth and innovation. The barriers to achieving a change in mindset and solutions for overcoming challenges prompt a call to action. This paper is an entreaty by a group of interprofessional educators passionate about ensuring all health professionals are trained to meet the complex needs of older adults.”
  • MedPage Today tells us,
    • “Chronic obstructive pulmonary disease (COPD) affects at least 4.5% of those 18-49 years old, according to an analysis of U.S. cohorts * * * as reported in NEJM Evidence.”
    • “The early COPD group was more likely to be hospitalized or die from chronic respiratory disease, to develop heart failure, and to die before 75 years of age from any cause.
    • “Having a definition for early COPD might allow for studies to find ways to treat the disease and reduce its impact.”
  • The AHA News informs us,
    • “Five pediatric flu deaths were reported to the Centers for Disease Control and Prevention last week, pushing the total to 266 for the 2024-2025 flu season, according to the latest data. The total is the highest reported in any non-pandemic flu season since the agency began reporting it in 2004. The CDC said 90% of reported pediatric deaths this flu season have happened to children who were not fully vaccinated against the flu.”
  • The American Medical Association lets us know what doctors wish their patients knew about the impact of caffeine.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Bristol Myers Squibb BMY and Bain Capital are forming a new biopharmaceutical company focused on therapies for autoimmune diseases.
    • The new company will be created with $300 million in financing led by Bain Capital, including funds from the Canada Pension Plan Investment Board.
    • The company will begin with five potential treatments for autoimmune diseases in-licensed from Bristol Myers Squibb, which will retain 20% equity in the new company. Bristol Myers Squibb will also be entitled to royalties and milestones from the potential treatments.
    • Biotech executive Daniel Lynch, currently chairman of the board at Xilio Therapeutics XLO, will lead the new company as chief executive.
  • Per BioPharma Dive,
    • “GSK is turning to a China-based biotechnology company in search of its next blockbuster medicine, announcing Monday a broad drug making alliance with Hengrui Pharma that could be worth billions of dollars.
    • “GSK will pay Hengrui $500 million upfront to start the alliance. In return, it will receive rights outside of the greater China region and Taiwan to an experimental drug for chronic obstructive pulmonary disease as well as the potential to develop up to 11 other therapies for respiratory illnesses, immune disorders or cancer. If a variety of milestones are met, the deal could be worth up to $12 billion, plus royalties, GSK said.”
  • Beckers Payer Issues offers us six prior authorization updates that Beckers has reported since June 23.
  • Per an NIH news release,
    • “Researchers at the National Institutes of Health (NIH) have developed an artificial intelligence (AI) agent powered by a large language model (LLM) that creates more accurate and informative descriptions of biological processes and their functions in gene set analysis than current systems.
    • “The system, called GeneAgent, cross-checks its own initial predictions—also known as claims— for accuracy against information from established, expert-curated databases and returns a verification report detailing its successes and failures. The AI agent can help researchers interpret high-throughput molecular data and identify relevant biological pathways or functional modules, which can lead to a better understanding of how different diseases and conditions affect groups of genes individually and together.”

Thursday report

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

From Washington, DC,

  • It’s worth noting that while the House of Representative has gone out of town for the August recess, the Senate will remain in session through next week.
  • The Wall Street Journal reports,
    • “Hospitals would be required to disclose how they make key decisions regarding extremely premature infants in a bill set to be introduced Thursday by Sen. Tom Cotton (R., Ark.).
    • “The legislation is in part prompted by a Wall Street Journal investigation last year that found mothers had been told no lifesaving measures were possible for their extremely premature infants, even though other hospitals nearby offered care for infants born at similar gestational ages.
    • “The Neonatal Care Transparency Act of 2025 would require hospitals to disclose publicly whether there is a minimal gestational age at which they offer active care for infants, rather than comfort measures before their death. While many hospitals require lifesaving measures to be given at 25 weeks’ gestational age or above, decisions on whether to attempt to save younger premature infants can vary by hospital or even doctor.”
  • Per Senate news releases,
    • “On Thursday, July 31, the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing on how to lower health costs and make health care more affordable for American patients.
      • “Title: Making Health Care Affordable: Solutions to Lower Costs and Empower Patients
      • “Date: Thursday, July 31, 2025
      • “Time: 10:00 AM ET/ 9:00 AM CT
      • “Location: 430 Dirksen Senate Office Building
      • “Click here to watch live”
  • and
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will hold a nomination hearing on Thursday, July 31, 2025, at 10:00 AM ET to consider Bryan Switzer to be a Deputy United States Trade Representative (USTR), Gustav Chiarello III to be an Assistant Secretary of Health and Human Services (HHS), Michael Stuart to be General Counsel of HHS and Derek Theurer to be a Deputy Under Secretary of the Treasury.
      • “Title: Hearing to consider nominees for USTR, HHS and Treasury
      • “Witnesses: Bryan Switzer; Gustav Chiarello; Michael Stuart; Derek Theurer
      • “Date: Thursday, July 31, 2025
      • “Time: 10:00 AM ET
      • “Location: 215 Dirksen Senate Office Building
      • “Witness testimony, opening statements and a live video of the hearing will be available on www.finance.senate.gov.”
  • The Society for Human Resource Management tells us,
    • “The annual employee contribution limit for dependent care flexible spending accounts (FSAs) is increasing by 50% beginning next year, a change employers will want to communicate to employees as open enrollment season gears up. 
    • “The massive tax law that President Donald Trump signed July 4, known as the One Big Beautiful Bill Act, raises the limit for the pretax benefit account used to pay for eligible dependent care services to $7,500 for single individuals and married couples filing jointly, up from $5,000, and $3,750 for married couples filing separately, up from $2,500. The increase is effective beginning Jan. 1, 2026.
    • “Industry experts have been pushing for a higher contribution limit for years, calling the new increase long overdue. Although other limits, such as for health savings accounts and medical FSAs, are indexed for inflation and usually increase nominally each year, that’s not the case for dependent care FSAs. The current limits have been in place since 1986, except for a temporary increase during the pandemic.
    • “The increase is a “game changer for both working parents and businesses,” said Sara Redington, co-founder of The Best Place for Working Parents (BP4WP), a Fort Worth, Texas-based organization that recognizes employers supporting working parents.”
  • Tammy Flanagan, writing in Govexec, discusses “Why federal retirements are spiking this year. A sharp rise in retirement claims may be tied to fear instead of planning. If you’re eyeing the exit, make sure you’re not rushing into something you’ll regret.”
  • Per STAT News,
    • “Everyone agrees that diet is important to good health. And yet fewer than a third of medical students receive the recommended minimum of 25 hours of nutrition education, and more than half report receiving no formal education on the topic at all. 
    • “That’s why health secretary Robert F. Kennedy Jr. may be pushing on an open door with his plans to require medical schools to include nutrition education in their curricula or else lose federal funding. 
    • “One of the things we’re gonna do at NIH is to really give a carrot and stick to medical schools across the country saying you gotta put in your first-year curriculum a really good, robust nutrition course,” he said in a video posted to his Instagram account earlier this month. 
    • “Medical experts who spoke with STAT noted that there is no standardized curriculum for nutrition, and that it’s not yet clear what specifics Kennedy may attach to funding or what training medical schools might have to cut back to make room for nutrition courses. But they were on board with Kennedy’s general goal, noting that many nutrition and food policy experts have been calling for this kind of change for years. A 2022 House of Representatives resolution on the need for better nutrition education also won bipartisan support. And some medical schools have already taken steps to strengthen their offerings on the subject.”

From the Food and Drug Administration front,

  • Fierce Pharma points out,
    • “Although Sarepta Therapeutics managed to defuse a brief stalemate with the FDA earlier this week, the U.S. drug regulator is reportedly going to put the company to work in order to affirm the safety of its Duchenne muscular dystrophy (DMD) gene therapy Elevidys.
    • “Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the company over a mounting string of controversies—to the FDA, Endpoints News reported Thursday, citing an unnamed senior FDA official.
    • “It’s unclear what sorts of studies Sarepta would need to run to get Elevidys back in the agency’s good graces, or whether the company might need to conduct a new clinical trial, Endpoints noted. The publication said it was unable to independently verify the internal FDA discussions alluded to by the official.
    • “That said, no one at the FDA thinks the treatment should return to market based on current data, an anonymous FDA official told Bloomberg.”
  • and
    • “Danish dermatology specialist Leo Pharma has scored an FDA approval that makes its JAK inhibitor cream Anzupgo (delgocitinib) the first therapeutic in the U.S. specifically indicated for chronic hand eczema (CHE).
    • “The endorsement covers adults with moderate to severe CHE for whom topical corticosteroids either have been inadequate or are not suitable. In September of last year, Anzpugo became the first topical treatment for the condition approved in Europe.
    • “Dermatologists hailed the approval as a long-awaited treatment option for a condition that is often overlooked despite it affecting 1 in 10 adults in the world. A recent study commissioned by Leo and conducted by Ipsos showed that more than half of nearly 200 dermatologists who were surveyed were frustrated by the lack of progress in the indication.
    • “They said current therapeutics for moderate to severe atopic dermatitis—which are often prescribed to treat CHE—don’t sufficiently translate as treatments for moderate to severe CHE.”
  • The American Hospital Association News lets us know,
    • “The Food and Drug Administration has identified a Class I recall of Edwards Lifesciences OptiSite Arterial Perfusion Cannula devices due to the potential for serious injury or death. Edwards identified incidents in which a 3mm to 4mm section of wire from the wire-reinforcement coil at the cannula tip was found to be exposed. The FDA said that some Femoral Arterial Cannula models are made of the same components as the OptiSite Arterial Perfusion Cannula models. Edwards has called for both products to be removed from wherever they are used or sold.”
  • Modern Healthcare reports,
    • “The Food and Drug Administration has classified Baxter’s recall of its Q-Link 13 mobile lift component as the most serious type, meaning it could lead to critical injuries or death if customers continue to use it.
    • “The Q-Link 13 is used with seven models of the company’s mobile lifts, which are used to move patients with limited mobility from one location to another or help with gait training.
    • “It’s an optional part that can be connected with a quick-release hook for sling bars, which hold the lifting sling. It could be attached incorrectly, possibly causing it to come loose and lead to a patient fall. This could result in serious injury to the patient or a caregiver trying to prevent the fall.
    • “This issue has potentially been associated with three serious injuries and one death, according to Baxter.”

From the judicial front,

  • The Northwest Arkansas Democrat Gazette reports,
    • “A federal judge on Wednesday said he will try to issue a ruling soon on whether a new state law banning pharmacies operated by out-of-state pharmacy benefit managers should be enjoined while the matter is being litigated in court.”
  • Govexec tells us,
    • “The Trump administration revealed to a federal court on Thursday the specific offices at which widespread layoffs were planned as of earlier this year, providing rare insight into the scale of its proposed reductions in force.” * * *
    • “The administration revealed the requests to the U.S. Court for the Northern District of California after Judge Susan Illston ordered their disclosure. Illston previously blocked the administration from moving forward with RIFs at all, but that injunction was overturned by the Supreme Court. The judge is now seeking to verify the legality of RIF plans on an agency-by-agency basis and sought information from 17 agencies the administration had told the Supreme Court were set to begin layoffs when Illston’s injunction took effect. 
    • “The Trump administration said the list in some cases undercounted the number of offices developing RIF plans and in others overcounted and has consistently maintained its plans were moving targets. An appeals court this week blocked another order from Illston requiring the administration to disclose to the court reorganization and RIF plans at every major agency, though those were not yet set to be made public.”  

From the public health and medical research front,

  • The AP reports,
    • “The fertility rate in the U.S. dropped to an all-time low in 2024 with less than 1.6 kids per woman, new federal data released Thursday shows.
    • “The U.S. was once among only a few developed countries with a rate that ensured each generation had enough children to replace itself — about 2.1 kids per woman. But it has been sliding in America for close to two decades as more women are waiting longer to have children or never taking that step at all. 
    • “The new statistic is on par with fertility rates in western European countries, according to World Bank data.
    • “Alarmed by recent drops, the Trump administration has taken steps to increase falling birth rates, like issuing an executive order meant to expand access to and reduce costs of in vitro fertilization and backing the idea of “baby bonuses” that might encourage more couples to have kids.
    • “But there’s no reason to be alarmed, according to Leslie Root, a University of Colorado Boulder researcher focused on fertility and population policy. 
    • “We’re seeing this as part of an ongoing process of fertility delay. We know that the U.S. population is still growing, and we still have a natural increase — more births than deaths,” she said.”
  • The Hill tells us,
    • “A new study suggests diets including eggs, especially the yolk, may help reduce the risk of Alzheimer’s disease.
    • “Published in The Journal of Nutrition, the study followed more than 1,000 U.S. adults and found that those who consumed more than one egg weekly had a 47 percent reduced risk of Alzheimer’s.
    • “Over an average follow-up of 6.7 years, 280 participants, or 27.3 percent, were diagnosed with Alzheimer’s dementia. Researchers found that 39 percent of the “total effect of egg intake” was linked to choline, a nutrient found in egg yolks known to support memory and brain function.
    • “Egg yolks also contain omega-3 fatty acids, which have neuroprotective benefits, further supporting brain health.”
  • The New York Times relates,
    • “Tens of millions of people in the United States struggle with obstructive sleep apnea, a condition that occurs when the throat muscles narrow during sleep, leading to temporary pauses in breathing that can cause people to snore and jolt awake, gasping for air.
    • “Poor sleep can leave people feeling exhausted, irritable and unfocused during the day. And if left untreated, sleep apnea can increase the risk for serious conditions like high blood pressure, Type 2 diabetes, heart attack and stroke.
    • “For decades, the primary treatment for sleep apnea has been continuous positive airway pressure (or CPAP). Before bed, those with the condition put on a face mask that is connected to a CPAP machine, which keeps the airway open by forcing air into it. The machines are effective, but many find them so noisy, cumbersome or uncomfortable that they end up abandoning them.
    • “Now, a more appealing option may be on the way, according to a news release from Apnimed, a pharmaceutical company focused on treating sleep apnea. On Wednesday, the company announced a second round of positive Phase 3 clinical trial results for a first-of-its-kind oral pill that can be taken just before bedtime to help keep a person’s airway open.” * * *
    • “Dr. Phyllis Zee, a sleep doctor and researcher at Northwestern Medicine who was not involved with the trial, said that if approved, the drug could transform the lives of many. That includes not only those who can’t tolerate CPAP machines, but also those who can’t — or prefer not to — use other interventions, such as other types of oral devices or weight loss medications. (Excess weight is a risk factor for sleep apnea.)”
  • Per STAT News,
    • “A Phase 3 study of AstraZeneca’s gefurulimab hit its primary and all secondary endpoints, teeing up talks with regulators about the potential blockbuster treatment for generalized myasthenia gravis, Fierce Biotech writes. AstraZeneca’s high hopes for the drug rest on the belief that the weekly, self-administered medicine can unlock an earlier, broader population than its existing gMG drug Ultomiris. In the study, people on gefurulimab performed significantly better on a gMG scale that assesses the ability to perform daily activities versus those on placebo, achieving the primary endpoint of the study.”
  • The U.S. Preventive Services Task Force released its Final Research Plan for Vision in Children Ages 6 Months to 5 Years: Screening.
  • Aunt Minnie adds,
    • “Changing national lung cancer screening guidelines in 2021 may have contributed to a surge in screening exams, but less lung cancer was detected in newly screened participants, and racial, ethnic, and sexual disparities persisted overall, according to a study published July 21 in the Journal of Thoracic Imaging.
    • “While numerous studies have examined the effects of the U.S. Preventive Services Task Force (USPSTF)’s 2021 lung cancer screening (LCS) guidelines on eligibility, this study focused on participation and lung cancer outcomes over the first 10 years of implementing an LCS program.” * * *
    • “Simply revising the guidelines increases eligibility but does not guarantee participation in LCS for these populations,” Lin and colleagues wrote. “These findings underscore the need for continued emphasis on active outreach and patient education efforts to promote LCS among racial and ethnic minority groups, as well as the further evaluation of how these initiatives impact participation and outcomes.”

From the U.S. healthcare business front,

  • Yahoo Finance lets us know,
    •  “Independence Blue Cross (IBX) is helping to improve recovery outcomes for its Medicare Advantage members after they leave the hospital and reduce costs with its Post-Acute Care Program. The program combines predictive analytics, proactive case management, and a focus on home-based recovery, to ensure members receive the right care at the right time after a stay at the hospital. Since its launch in July 2022, it has helped to improve CAHPS survey scores—a tool used to measure members’ experiences with health care services and strengthen health care in the U.S. It has also delivered $13 million in cost savings and earned the prestigious Blue Cross Blue Shield Association’s (BCBSA) North Star Award for its measurable impact.”
  • Per Beckers Payer Issues,
    • “Priority Health, the insurance arm of Grand Rapids, Mich. based Corewell Health, will become the governing member of Group Health Cooperative of Eau Claire, a Wisconsin-based health plan with more than 61,000 members.
    • “Both organizations expect the transaction to close by the end of 2025, pending regulatory approvals.
    • “The agreement will make Priority Health a four-state health plan with more than 1.3 million members across Michigan, Indiana, Ohio and Wisconsin.”
  • Per the AHA News,
    • “The AHA July 24 announced it is collaborating with health care technology leader Epic to help hospitals adopt tools that support the early detection and treatment of postpartum hemorrhage, a leading cause of maternal mortality. 
    • “The organizations have released a toolkit that includes dynamic risk assessments, clinical decision support and treatment guidance embedded in the electronic health record. With the proper permissions from applicable content providers, users of any EHR should be able to implement a similar set of tools. 
    • “The American Hospital Association and Epic share a deep commitment to improving health outcomes for moms and babies,” said Chris DeRienzo, M.D., AHA chief physician executive and a neonatologist. “This new collaboration amplifies our efforts to drive continuous improvement by sharing evidence-based resources to help reduce this tragic condition. It’s a natural extension of AHA’s Patient Safety Initiative, a collaborative data-driven effort to highlight and learn from patient safety progress at hospitals and health systems around the country.” 
    • “The AHA and Epic will support hospitals in their implementation journey with programming, resources and a space to learn from each other and engage with hospitals already seeing successful outcomes with items that are included in the toolkit.”
  • Healthcare Dive informs us,
    • “Labcorp has agreed to acquire certain ambulatory outreach laboratory assets from Community Health Systems, furthering an expansion push that has seen the testing services provider forge deals with a growing list of local and national health systems.
    • “The $195 million cash agreement with CHS includes patient service centers and in-office phlebotomy locations in 13 states, where Labcorp will assume some facility leases.
    • “Evercore ISI analyst Elizabeth Anderson, in a note to clients Tuesday, called the deal “very much in-line with [Labcorp’s] long-stated hospital management and outreach strategy where it continues to build a strong track record.”

Tuesday report

David Ermer–CDC, Congress, FDA, Medical / Rx research, OPM, Patient safety, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The FEHBlog watched the closing of today’s Senate session. He learned that late tomorrow morning the Senate will vote to invoke cloture on the nomination of Scott Kupor to be OPM Director for a four-year term and if cloture is invoked the Senate will vote to confirm Mr. Kupor’s nomination tomorrow afternoon.
  • Govexec tells us,
    • “President Trump on Monday extended his administration’s hiring freeze of all federal civilian positions for another three months, leaving in place the moratorium into the start of fiscal 2026.
    • “The freeze, which the president initially ordered on Jan. 20, the day he took office, prevents the hiring of civilian employees at federal agencies for either vacancies or new positions. The initial executive order was set to run through April 20 and was subsequently extended until July 15.
    • “As with previous orders, the freeze exempts positions related to immigration enforcement, national security or public safety, as well as the components of the Executive Office of the President. The order also reiterated that roles will be filled to protect the “provision of Social Security, Medicare, or veterans’ benefits.” Despite the carveouts, the Defense Department continues to operate under a partial hiring freeze of its own for civilian personnel.” 
  • Per MedTech Dive,
    • “Boston Scientific said Monday it gained Food and Drug Administration approval for use of its Farapulse pulsed field ablation system in people with persistent atrial fibrillation, broadening the pool of patients eligible for the treatment.
    • “Farapulse has become a significant growth driver for Boston Scientific as physicians embrace the technology for its potential safety benefits over traditional cardiac ablation methods to treat AFib, an irregular heartbeat that increases stroke risk.
    • “The label expansion, for both the Farawave and Farawave Nav PFA catheters, was backed by evidence from the first phase of the Advantage AF clinical trial, which met its primary safety and effectiveness goals.”
  • Cardiovascular Business adds,
    • “Boston Scientific has received an expanded approval from the U.S. Food and Drug Administration (FDA) for its Farapulse Pulsed Field Ablation (PFA) System. More U.S. heart patients are now eligible to be treated with the technology than ever before.
    • “The Farapulse PFA system first gained FDA approval to treat patients with symptomatic, paroxysmal atrial fibrillation (AFib) back in January 2024. This new approval covers patients with symptomatic, persistent AFib that is resistant to drug treatment. 
    • “Backed by clinical evidence and our global commercial experience, this update advances our efforts to further shape the future of AFib treatment with safe and effective ablation technologies,” Brad Sutton, MD, chief medical officer of AFib solutions for Boston Scientific, said in a statement. “We look forward to studying the system in new clinical trials, including patients in need of re-do ablations and those with more complex arrhythmias, which account for a large portion of the procedures today still using thermal ablation.”

From the judicial front,

  • The Wall Street Journal reports,
    • “The Supreme Court on Tuesday lifted a halt on President Trump’s plan to shrink the federal workforce, clearing the way for potential mass layoffs. 
    • “In February, Trump issued an executive order aimed at drastically reducing the government’s workforce “by eliminating waste, bloat, and insularity.” The order directed heads of agencies to work with the Department of Government Efficiency on hiring decisions and developing plans for layoffs. In May, a federal judge in San Francisco blocked it from taking effect
    • “The high court, in an unsigned order on Tuesday, said it had based its decision on the legality of Trump’s executive order, and didn’t rule on whether any reorganization plans broke the law.  
    • “The Government is likely to succeed on its argument that the Executive Order and Memorandum are lawful,” the court said. 
    • “Justice Ketanji Brown Jackson dissented, accusing the court of greenlighting legally dubious actions.” * * *
    • “Justice Sonia Sotomayor on Tuesday wrote separately to concur with the court’s decision to lift the halt, noting that the plans themselves weren’t before the high court. She said the district court could still consider the legality of the layoff plans.”
       
  • Fedweek adds,
    • OPM said “hundreds of thousands” of federal employees accepted deferred resignation offers while confirming that “tens of thousands” are facing layoffs in pending RIFs.
    • OPM made that statement in the first—although not exact—accounting of the government-wide impact of those offers, and touted a reduction in the federal employee count on its FedScope site to just under 2.29 million through March, down by some 23,000 from last September.
    • “In addition, hundreds of thousands more workers will drop off the rolls in October 2025, when workers depart the federal government as part of the Deferred Resignation Program; and tens of thousands of employees who have received reduction-in-force or termination notices remain on government payrolls due to court orders that the administration is now challenging,” the OPM said prior to Tuesday’s SCOTUS decision siding with the White House.
  • Per Fierce Healthcare,
    • “Southwest Airlines is buckling up to join in on a long-running legal battle surrounding an alleged price-fixing scheme involving generic medicines in the U.S.
    • “In a 730-page lawsuit filed in federal court in Pennsylvania, the airline targets dozens of drugmakers and argues the companies “deprived the public” of the benefits of cheaper generic drugs by fixing the price of their meds since at least 2009. Among the generic defendants named are Teva Pharmaceutical Industries, Sandoz, Dr. Reddy’s Laboratories, Lupin and Apotex.
    • “The scheme cost Southwest, a large employer that self-funds its employee health plans, “hundreds of millions of dollars” and caused “substantial injury” to its business, the company claims in the recently unsealed lawsuit.” * * *
    • “American Airlines and Target are among other large employers that have sued the group of generic drugmakers. The companies filed a joint lawsuit in the same court back in April 2024, Bloomberg Law reported at the time. 
    • “The issue is also playing out in pending multi-district litigation grouping more than 20 separate lawsuits that date back to 2016. A handful of drugmakers, including Sandoz, Apotex, and Sun Pharma, have so far agreed to multi-million dollar settlements to resolve their end of the claims.” * * *
    • “Southwest, for its part, cited the federal government’s prosecution efforts in its own case. At least seven companies have admitted to criminal wrongdoing, according to the Department of Justice, and have agreed to fork over hundreds of millions of dollars in fines, civil penalties and restitution.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention July 7 announced it is streamlining H5N1 bird flu updates with its routine influenza data given the low public health risk and lack of person-to-person spread. Data on the number of people monitored and tested for bird flu will be reported monthly.
    • “Bird flu detection data in animals will no longer be reported on the CDC website; instead, it will be publicly available on the U.S. Department of Agriculture website.”
  • and
    • “A study published July 7 by JAMA found children’s health has significantly worsened from 2007 to 2023. Researchers studied changes in child mortality; chronic physical, developmental and mental health conditions; obesity; sleep health; early puberty; limitations in activity; and physical and emotional symptoms. Researchers said the findings highlight the need to identify root causes for the decline in health.”
  • Beckers Clinical Leadership lets us know eight things to know about the JAMA report on children’s health.
  • STAT News reports,
    • “Female hearts are different from male hearts, down to their cell populations and up to the thickness of their walls, making cardiovascular care far from one-size-fits-all. There’s a growing appreciation that heart attack symptoms occur on a spectrum. Women may not have the classic crushing chest pain that men do; they may feel a subtler, wider discomfort that can delay care. 
    • “There’s another potentially deadly, dramatic difference. Men are much more likely than women to suffer sudden cardiac arrest, but when female athletes do collapse on the playing field from sudden cardiac arrest, they are less likely than male athletes to be resuscitated right away, despite coaches, trainers, or teammates watching on the sidelines. That’s a disparity women share outside sports events with people of color, whose chances of receiving life-saving help from bystanders are even lower. 
    • “Across disciplines, scientists are arguing for the importance of studying sex differences throughout biomedical research. Sports medicine researchers are also bringing new attention to women, from young competitors in the spotlight to older amateurs trying to stay active.” “
  • Beckers Hospital Review points out,
    • “Mississippi had the highest mortality rate across all cancer types between 2018 and 2022, according to data published by the American Cancer Society. 
    • “The American Cancer Society used data from the North American Association of Central Cancer Registries to calculate mortality rates per 100,000 people for each state and each cancer type.
    • “Read the states with the highest cancer incidence, by type, here.”
  • and
    • “A commonly prescribed medication used to counteract lung cancer therapy side effects could be minimizing a cancer treatment’s efficacy, according to research from Los Angeles-based Keck Medicine of USC. 
    • “To evaluate how baseline steroid use can affect immune checkpoint inhibitor therapy, researchers analyzed clinical outcomes of 277 patients with non-small cell lung cancer. Corticosteroids, a frequently prescribed steroid to treat side effects common to this type of lung cancer, was associated with worse outcomes, the study found. 
    • “Among 88 patients at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., and 189 at the University of Southern California in Los Angeles who received immune checkpoint inhibitor therapy, 21 were taking steroids at the start of ICI therapy. Compared to those not taking corticosteroids, these patients experienced a higher number of negative effects. 
    • “The study, published July 7 in Cancer Research Communications, found a worse overall response rate and shorter overall survival and progression-free survival rates among lung cancer patients taking the steroid concurrent with ICI therapy. 
    • “Additionally, higher doses of corticosteroids severely affected ICI therapy and patient outcomes more than small or medium doses.”
  • Per Health Day,
    • “Some women have expressed concerns about the risk of breast cancer associated with using hormone therapy to treat symptoms of menopause like hot flashes and night sweats, and now, new research suggests that one type of hormone therapy might increase your risk if you’re younger than 55.
    • “Women in this age group who were treated with estrogen plus progestin were more likely to develop breast cancer than those not on hormone therapy, researchers report in The Lancet Oncology.
    • “On the other hand, women younger than 55 given estrogen alone, without progesterone, had a lower risk of breast cancer, results show.
    • “Hormone therapy can greatly improve the quality of life for women experiencing severe menopausal symptoms or those who have had surgeries that affect their hormone levels,” lead author Katie O’Brien, an epidemiologist with the National Institute of Environmental Health Sciences, said in a news release.”
  • Per BioPharma Dive,
    • “Biotech and pharma companies are searching for ways to “hijack” the cell’s waste disposal systems in hopes of making more effective drugs.”
  • and
    • “Glucotrack, which is developing a glucose monitor that is implanted through a minimally invasive surgery, said the small study met safety and performance goals.”

From the U.S. healthcare business front,

  • Risk and Insurance reports,
    • “Medical stop loss claims are undergoing significant shifts as cancer diagnoses remain dominant across all deductible levels while million-dollar claims have doubled in frequency over four years, driven by expensive treatments and rising disease prevalence among younger populations, according to analysis by QBE.” * * *
    • “View the full report here.”
  • Check out Adam J. Fein who writes in Drug Channels,
    • “The 2025 launch of biosimilars to Johnson & Johnson’s Stelara (ustekinumab) marks another turning point in pharmacy benefit dynamics. But unlike the chaotic rollout of Humira biosimilars, pharmacy benefit managers (PBMs) came prepared.
    • “Private label strategies, aggressive pricing, and exclusive formulary deals have transformed what might have been a slow-crawling biosimilar introduction into a full-on pricing war. As with Humira, the reality of biosimilar economics is far messier—and more revealing—than the policy narratives suggest.
    • “In this post, I examine how the major PBMs—and some of the smaller ones—are handling Stelara biosimilars, what’s changed since the Humira experience, and why their strategies reflect the growing dominance of private-label rebating schemes.”
  • Beckers Hospital Review calls attention to “18 health systems that recently had their outlooks upgraded by Fitch Ratings or Moody’s Investors Service in 2025, and considers the state of virtual nursing
    • “Virtual nursing has continued to expand since bursting onto the scene a few years ago. But has the care model lived up to its promise?
    • “Health system leaders told Becker’s that virtual nursing still has room to grow but has had positive benefits for the industry thus far.
    • “While virtual nursing has proven effective at boosting patient outcomes and satisfaction, its broader adoption faces significant barriers: high implementation costs, complex regulatory policies and the challenge of integrating new hospital workflows,” said Zafar Chaudry, MD, senior vice president and chief digital, AI and information officer of Seattle Children’s.”
  • Per Fierce Healthcare,
    • “Nearly all states saw declines in the number of acute care hospitals offering obstetric services between 2010 through 2022, with seven states seeing a quarter or more of their hospitals dropping obstetric care, according to new analysis.
    • “The shutdowns were spread across urban and rural hospitals alike, but more pronounced in the latter. Twelve states lost obstetric services among a quarter or more of their hospitals, and by 2022, there were eight states in which more than two-thirds of all rural hospitals did not offer obstetric care, researchers found.” * * *
    • “Rural hospital obstetrics closures exceeded more than 40% in Pennsylvania (46.2%), South Carolina (46.2%), West Virginia (42.9%) and Florida (40%) between 2010 and 2022. Urban hospital closure percentages were less pronounced among individual states, with Rhode Island (28.6%), Oklahoma (27.6%) and Hawaii (25%) leading the way.
    • “Three states—Delaware, Utah and Vermont—had no hospital obstetric service losses during the study window, as opposed to the seven (Iowa; Oklahoma; Pennsylvania; Rhode Island; South Carolina; Washington, D.C.; and West Virginia) that saw cuts among a quarter or more of their hospitals. Rural-urban divides were also spotted within individual states, such as New Hampshire, where 36.4% of rural hospitals lost obstetrics as opposed to zero urban hospitals.
    • “Access to obstetric care is a key determinant of health outcomes among mothers and infants, the researchers wrote. The study’s findings could be a resource for policymakers and others to craft targeted, state-level interventions addressing access disparity.”
  • and
    • “Humana’s senior-focused primary care unit is set to acquire The Villages Health, which provides care to the large Florida-based retirement community.
    • “The Villages Health filed for bankruptcy last week as it seeks to undergo a strategic restructuring designed to “preserve the business’s day-to-day operations and further enhance patient care.” Humana’s CenterWell has entered a “stalking horse” agreement to buy TVH’s assets, according to an announcement.
    • “Finalizing the sale will require a court order after an auction process that accepts additional bids. As it navigates the sale and bankruptcy proceedings, The Villages Health said it will continue to operate as normal, with the goal of averting disruptions to patient care.
    • “As CenterWell is payer-agnostic, current TVH patients are “expected” to be able to maintain the relationship with their existing providers, according to the release.”

Monday update

David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The FEHBlog noticed today that the Speaker of the House of Representatives has declared this week to be a District work week for members of the House. As a result, the previously scheduled House Committee meetings have been cancelled or postponed.
  • Fierce Healthcare reports,
    • “Congress has made permanent a pandemic-era telehealth provision for millions of Americans with high-deductible health plans.
    • “In its massive tax package signed into law on July 4, Congress included a last-minute provision to allow employer-sponsored health plans to offer covered telehealth services before employees meet their deductibles.
    • “Under high deductible health plans, patients typically have to pay out of pocket for healthcare services until they meet their deductible, with an exception for preventive care services. 
    • “Now, employers will be able to offer digital healthcare services to their employees for little to no out-of-pocket cost. The telehealth safe harbor policy also allows employers to waive copays for digital health. 
    • “Congress extended the tax provision multiple times throughout the COVID-19 pandemic to allow commercially insured patients the option to receive care from anywhere. The policy was allowed to lapse at the end of 2024 when it did not make it into the end-of-year healthcare package. 
    • “The telehealth safe harbor policy in reconciliation applies to all plan years beginning after December 31, 2024.”
  • MedPage Today tells us,
    • With the CDC director’s chair still empty, HHS Secretary Robert F. Kennedy Jr. endorsed recommendations made months ago by former members of the Advisory Committee on Immunization Practices (ACIP) to expand access to respiratory syncytial virus (RSV) vaccination, as well as to add a new option for meningococcal vaccination. * * *
    • “A notice this [past] week appeared on the CDC’s website, which details the recommendations from the April ACIP meeting: “With no current CDC Director and pending confirmation of a new CDC Director this recommendation was adopted by the HHS Secretary on June 25, 2025, and is now an official recommendation of the CDC.”
    • The new RSV recommendation calls for a single dose of vaccine for adults age 50 to 59 years who are at increased risk of severe RSV disease. 
    • “The CDC also endorsed the previous ACIP members’ recommendation that GSK’s pentavalent Neisseria meningitidis (groups A, B, C, W, and Y) vaccine (Penmenvy) may be used when both the MenACWY and MenB vaccine are indicated at the same visit. That recommendation applies to healthy people ages 16 to 23 years “when shared clinical decision-making favors administration of MenB vaccine.” The recommendation also covers people age 10 years or older “who are at increased risk for meningococcal disease (e.g., because of persistent complement deficiencies, complement inhibitor use, or functional or anatomic asplenia).” Committee members also voted to include the shot in the Vaccines for Children program.”
  • The Washington Post informs us,
    • “The Department of Veterans Affairs said Monday [July 7] that it will no longer be forced to conduct a large reduction in workforce, unlike several other federal agencies that were forced to make mass layoffs because of the Trump administration’s U.S. DOGE Service.
    • “In a news release, VA said that it was on pace to reduce its total staff by nearly 30,000 employees by the end of this fiscal year, a push that the department said eliminates the need for a “large-scale reduction-in-force.” The announcement marks a significant reversal for the Trump administration, which had planned for months to cut VA by roughly 83,000 employees, according to plans revealed in an internal memo circulated to agency staffers in March.” 
  • MedTech Dive lets us know,
    • “The U.S. plans to charge up to 70% tariffs on imports from some countries starting Aug. 1 as President Donald Trump’s 90-day pause on his country-specific reciprocal duties nears its expiration date.
    • “Starting Monday at noon EST, the U.S. will send letters detailing tariff rates for specific trading partners that have yet to reach a tariff deal with the Trump administration before the pause ends July 9, the president said Sunday. Trump told reporters Friday that the rates would range between 10% and 70%.
    • “The U.S. is specifically focused on “18 important trading relationships,” Treasury Secretary Scott Bessent said on CNN’s “State of the Union” Sunday. He also indicated that countries that do not reach deals in the next few days will return to the tariff rate Trump first outlined as part of the president’s global reciprocal tariff announcement April 2.
    • “President Trump’s going to be sending letters to some of our trading partners, saying that, if you don’t move things along, then, on August 1, you will boomerang back to your April 2 tariff level,” Bessent said.”
  • The American Hospital Association (AHA) News relates,
    • The National Institutes of Health July 3 announced that all NIH-funded research published in scientific journals must be made publicly accessible immediately upon release, accelerating a policy originally set to begin in December. Previously, many NIH-funded studies in journals were password-protected and not widely available to nonsubscribers.

From the judicial front,

  • Healthcare Dive reports,
    • “Six medical groups and a pregnant physician have sued Health and Human Services Secretary Robert F. Kennedy Jr. and his principal deputies over changes made to federal COVID-19 vaccine recommendations.
    • Filed Monday, the lawsuit argues that Kennedy’s directive, which removed guidelines recommending COVID vaccination for pregnant people and healthy children, is unlawful and “a pressing public health emergency that demands immediate legal action and correction.”
    • “The Directive is but one example of the Secretary’s agenda to dismantle the longstanding, Congressionally-authorized, science- and evidence-based vaccine infrastructure that has prevented the deaths of untold millions of Americans,” the suit states.
    • “Plaintiffs include the American Academy of Pediatrics, the American Public Health Association, the Infectious Diseases Society of America and several other groups.”
    • The case is captioned American Academy of Pediatrics v. Kennedy, Case No. 1:25-cv-11916 (D. Mass.).

From the public health and medical research front,

  • Last Wednesday, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced, 
    • “Kraft Heinz Foods Company, a Newberry, S.C., establishment, is recalling approximately 367,812 pounds of fully cooked turkey bacon products that may be adulterated with Listeria monocytogenes (Lm). The turkey bacon was produced from April 24, 2025, through June 11, 2025. The following products are subject to recall [view labels]:
      • “12-oz. vacuum-packed packages of “Oscar Mayer Turkey BACON ORIGINAL” and universal product code (UPC) “071871548601” printed on the packaging under the barcode,”use by” dates ranging “18 JUL 2025” to “02 AUG 2025,” and lot code “RS40.”
      • “36-oz. packages containing three 12-oz. vacuum-packed packages of “Oscar Mayer Turkey BACON ORIGINAL” and universal product code (UPC) “071871548748” printed on the packaging under the barcode, “use by” dates ranging “23 JUL 2025” to “04 SEP 2025,” and lot codes “RS19,” “RS40,” or “RS42.”
      • “48-oz. packages containing four 12-oz. vacuum-packed packages of “Oscar Mayer Turkey BACON ORIGINAL” and UPC “071871548793” printed on the packaging under the barcode and “use by” dates ranging “18 JUL 2025” to “04 SEP 2025,” and lot codes “RS19,” “RS40,” or “RS42.”
    • “The products subject to recall bear the USDA mark of inspection on the front of the label. These items were shipped to retail locations nationwide and some were exported to the British Virgin Islands and Hong Kong.” * * *
    • “FSIS is concerned that some products may be in consumers’ refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.”
  • Per Axios.
    • “It’s not food, it’s not chewing tobacco and it’s not gum — though it might look like it when you see it — but it is becoming America’s new addictive obsession.
    • “Sales of Zyn nicotine pouches are soaring, prompting the tobacco company that makes them to scramble to boost U.S. production to meet demand.” * * *
    • “Threat level: The product is addictive because nicotine is addictive.
      • “But it does not cause cancer since it doesn’t contain tobacco, whose harmful chemicals are carcinogenic. As a result, advocates say nicotine pouches can serve as a safer alternative to smoking.
      • “Philip Morris International U.S. CEO Stacey Kennedy argued that nicotine is “misunderstood” and contains “cognitive benefits.”
      • “You have to be able to separate out the misconceptions of what causes harm — and nicotine is probably one of the most misunderstood compounds, because many people believe that nicotine is responsible for smoking-related disease, and it’s not,” Kennedy said in an interview.
    • Yes, but: Tobacco industry watchdogs say products that contain nicotine, such as pouches and e-cigarettes, can serve as a gateway to smoking, especially for teens.
  • Per MedPage Today,
    • “Parent nudges and clinician feedback/audits boosted HPV vaccination uptake and completion.
    • “Adolescents with the most economic disadvantage, rural kids, and Black children saw the least benefit.
    • “More research is needed to tailor interventions to improve HPV vaccine uptake and completion for these groups.”
  • The American Medical Association lets us know what doctors wish their patients knew about hyperthyroidism.
  • Consumer Reports, writing in the Washington Post, points out “What to eat to protect your aging muscles. The foods you choose are as important as exercise for getting and staying strong.”
  • BioPharma Dive informs us,
    • After a delay due to “resource constraints,” the Food and Drug Administration on Monday [July 7] approved Kalvista Pharmaceuticals’ pill Ekterly to treat swelling attacks in people with the rare disorder hereditary angioedema.
    • Ekterly is the first oral drug to treat hereditary angioedema, or HAE, attacks, competing with shots like Firazyr from Takeda and Ruconest from Pharming. Analysts have estimated Ekterly, Kalvista’s first marketed drug, could bring in $600 million a year in U.S. sales at its peak.
    • The FDA delayed the decision beyond its June 17 deadline, Kalvista said, because of a “heavy workload and limited resources.” While Kalvista awaited its decision, the FDA granted approval to another HAE drug, CSL’s Andembry, a preventive shot that won’t compete directly with Ekterly.
  • STAT News reports,
    • “Apogee Therapeutics said Monday [July 7] that its experimental antibody treatment alleviated the signs and symptoms of atopic dermatitis, a common inflammatory skin condition, far more than a placebo — achieving the efficacy goals of a mid-stage clinical trial.
    • “In a side-by-side comparison, the Apogee drug, called APG777, showed similar skin-clearance rates compared to two antibody treatments already on the market: Sanofi and Regeneron’s Dupixent and Ebglyss from Eli Lilly. 
    • “APG777 was designed to be injected quarterly or twice-yearly, which, if proven in later clinical trials, would make it more convenient than the twice-monthly and monthly injections required for its competitors.” 
  • and
    • “Cogent Biosciences said Monday that its experimental drug reduced the symptoms of a chronic immune disorder called indolent systemic mastocytosis. The results mean the drug achieved the goals of a Phase 3 study, but a comparison to a rival treatment from Blueprint Medicines remains muddled. 
    • “In its study, Cogent’s drug, called bezuclastinib, showed a 24-point improvement in a patient-reported symptoms score, compared to a 15-point improvement for participants given a placebo. The nine-point difference was statistically significant. 
    • “Indolent systemic mastocytosis is the most common form of an immune system disorder that causes allergic-like skin reactions, gastrointestinal and neurological symptoms, fatigue, and generalized pain.” 

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Molina Healthcare warned higher medical costs will hit earnings this year, adding to Wall Street worries.
    • “New legislation will shrink the number of insured, especially Medicaid, creating uncertainty for insurers.
    • “Insurers are seeing that rising mental-healthcare use and costly drugs, like weight-loss medications, increase spending.”
  • Per MedPage Today, “Obesity Drug Prices Are Dropping, but Getting a Steady Supply Remains a Challenge — Insurance coverage remains inconsistent.”
  • Beckers Hospital Review lets us know,
    • “A new study suggests that the introduction of a real-time prescription benefit tool did not lead to meaningful changes in prescription spending or medication use among Medicare Advantage beneficiaries during its first year of implementation. 
    • “The analysis, published in JAMA Network Open, examined more than 2.8 million beneficiaries and compared patients treated with access to the tool to those without it. The tool, integrated into EHRs in 2019, helps provide clinicians with real-time cost and coverage information at the point of prescribing. 
    • “Despite hopes that the tool would lower out-of-pocket costs and increase prescription adherence by guiding prescribers toward lower cost alternatives, the study found no significant difference in total prescription spending, out-of-pocket costs or number of prescription fills between the two groups.” 

Tuesday report

David Ermer–ACA, AHRQ, CMS, Congress, FDA, Medical / Rx research, NIH, Patient safety, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump is urging Republicans to get their “one big, beautiful bill” to his desk by July 4. That’s just a week from Friday, and lawmakers still face a series of hurdles and headaches on issues ranging from artificial intelligence to deficit spending to rural hospitals.
    • “Senate GOP leaders are revising their version in advance of potential votes later this week, searching for a mix that can garner a majority in the chamber, which is divided 53-47. Anything that gets through the Senate must pass the House, which is divided 220-212 in Republicans’ favor; any subsequent House changes would require another Senate vote. Lawmakers are scheduled to leave Washington for a recess next week but signaled they were prepared to stay to finish the bill.”
  • The American Hospital Association News tells us,
    • “Secretary of Health and Human Services Robert F. Kennedy Jr. today appeared before the House Energy and Commerce Subcommittee on Health for a hearing to testify on the HHS fiscal year 2026 budget proposal, which requests $94.7 billion.”  
  • Modern Healthcare informs us,
    • Prescription drug middlemen should end the complicated system of drug rebates before the government steps in to change it, Medicare and Medicaid chief Mehmet Oz said Tuesday.
    • The remarks signal the Trump administration may revive attempts to eliminate the payments drugmakers send to pharmacy benefit managers after prescriptions are filled. In his first term in 2019, President Donald Trump considered regulations that would have eliminated that system, but officials abandoned them before they went into effect.
    • “There’s a possibility that we have a window now where the three big PBMs might actually consider doing away with the rebate-slash-kickback system,” Oz told a meeting hosted by Transparency-Rx, a coalition of smaller PBMs committed to more open pricing. The three largest companies in the industry, CVS Health Corp., UnitedHealth Group and Cigna Group, handle about 80% of US prescriptions.” * * *
    • “Oz met with large insurers about separate issues on Monday. The insurers voluntarily committed to reduce the use of preapprovals for medical care, and Oz said that there could be an opportunity for insurers to take similar voluntary action to change how they pay for medicines.”
  • Healthcare Dive also discusses the CMS Administrator’s presentation at this meeting with a focus on drug price transparency.
  • Federal News Network lets us know,
    • “Rep. Robert Garcia was elected the top Democrat on the powerful House Oversight Committee on Tuesday, charting a new direction for the party’s opposition to congressional Republicans and President Donald Trump’s administration.
    • “Garcia, of California, won the job overwhelmingly in a closed-door vote of the House Democratic caucus. He beat out Rep. Stephen Lynch of Massachusetts, 150-63.”
  • Fierce Healthcare summarizes the public comments submitted in response to the May 13, 2025, CMS and National Coordinator of Health IT RFI “on how to ease data exchange among the healthcare ecosystem for patients, providers, payers, vendors and value-based care organizations.”
  • Fierce Healthcare also points out,
    • “While major provider organizations welcomed insurers’ pledge earlier this week to reform prior authorization, these groups withheld praise without yet seeing the efforts bear fruit.
    • “Bobby Mukkamala, M.D., president of the American Medical Association, said in a statement that patients and physicians both will need to see the promises made yield significant results to ease the headaches around prior auth.
    • “Mukkamala said that many of the elements of Monday’s pledge echo a 2018 consensus statement from major payer and provider organizations, such as reducing the number of required prior authorizations, preserving the continuity of care for the patient and expanding automation.
    • “He said the AMA will “closely monitor” the rollout of the prior authorization changes and continue to work with regulators and legislators on this issue.”
  • The U.S. Preventive Services Task Force today gave a Grade B to “screening women of reproductive age, including those who are pregnant and postpartum for intimate partner violence.” The USPSTF also “concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening for caregiver abuse and neglect in older or vulnerable adults [Grade I]. Both grades are consistent with the conclusions that the USPSTF reached in 2018 following a similar analysis.
  • MedPage Today adds,
    • “Expanding eligibility criteria for lung cancer screening to include 20-year smoking history without requiring a certain number of pack-years yielded a relative 28% increase in the number recommended for screening.
    • “The number of lung cancers identified would have increased by a relative 17%.
    • “The increase in detection was particularly seen among women and Black persons, groups with under-detection by current criteria.”
  • Per PR Newswire,
    • “More than 1.3 million women in the U.S. enter menopause every year. Menopause affects every woman—but not every woman gets the care, clarity, and support she deserves. A new national program, “Menopause for All,” intends to change that and will launch in Baltimore, MD and Washington, D.C., on June 28th and 29th, respectively.
    • “The National Menopause Foundation, a leading patient advocacy organization dedicated to empowering women with the knowledge and resources they need to navigate menopause through igniting community and harnessing science, has teamed up with Perry, a pioneering digital health platform transforming perimenopause care through expert-led community support, evidence-based education, and training of health care professionals. Together, they believe menopause care should be local, personal, and accessible.
    • From trusted medical professionals and wellness experts to culturally sensitive support groups, the Menopause for All program will help women and their families connect with resources in their own local communities—because navigating menopause shouldn’t be done alone or in the dark.
    • Menopause for All events are free and open to the public, but space is limited. On Saturday, June 28, 2025, the event will be held at Enoch Pratt Free Library, 400 Cathedral Street in Baltimore, MD from 1:30-4:30 p.m. On Sunday, June 29, 2025, the event will be held at the Hill Center at the Old Navy Hospital, 921 Pennsylvania Avenue, SE Washington, D.C., from 2:30-5:30 p.m.
    • “Our expert-led sessions will provide women with practical, scientifically-backed guidance and real solutions ensuring every woman has the care and support she deserves,” added Claire Gill, founder and President of NMF. “We’re grateful to our presenting sponsor [and FEHB, PSHB and FEDVIP carrier] Government Employees Health Association (G.E.H.A) and supporting sponsor Clearblue for their commitment to advancing women’s midlife health.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “The FDA has blessed AstraZeneca and Daiichi Sankyo’s Datroway to treat patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). The accelerated nod—which could hinge upon verification of clinical benefit in a confirmatory trial—applies to patients who have received prior EFGR-related treatment and platinum-based chemotherapy.
    • “The label expansion comes five months after Datroway secured its first FDA nod, for patients with previously treated metastatic, HR-positive, HER2-negative breast cancer. With the nod, Datroway becomes the first TROP2-directed therapy in the U.S. for NSCLC.
    • “Addressing disease progression in patients with advanced EGFR-mutated lung cancer after prior targeted therapy and chemotherapy is very challenging with limited later-line treatment options available,” Jacob Sands, M.D., of the Dana-Farber Cancer Institute and an investigator in two trials that paved the way for the latest approval, said in a June 23 press release.”
  • STAT News relates,
    • “A sutureless device for peripheral nerve repair could be available on the market in the coming months.
    • “The Food and Drug Administration has authorized a polymer-based device developed by medical technology company Tissium. The authorization, announced Tuesday, will give physicians a new method for treating peripheral nerve injuries.
    • “This approval is really a game-changer for patients with peripheral nerve injuries,” said Jeffrey Karp, a Tissium co-founder who developed the device’s technology. “For the first time, surgeons now have a sutureless, bio-inspired option that can really simplify the procedure while improving outcomes.”
  • Per Cardiovascular Business,
    • “The U.S. Food and Drug Administration (FDA) has announced an expansion of an earlier Medtronic recall, now issuing a new Class 1 recall for Medline Industries’ procedure kits that contain Medtronic aortic root cannulas. The recalls indicate that there may be excess material in the male luer, which could potentially lead to serious adverse events, including procedure delays, neurological deficits, strokes, or even death.”
  • Per Health Exec,
    • “In what is being referred to as a recall, the U.S. Food and Drug Administration (FDA) released a notice on behalf of GE HealthCare for a line of its Carestations due to a risk the ventilation systems may not work properly. Despite the serious risk of death or injury caused by inadequate respiration, the problem has been isolated and can be fixed with updated use instructions. 
    • “Although no devices have been removed from care settings, this recall has been designated a Class I by the FDA, reserved for the most serious issues. Luckily, no injuries or deaths have been reported. 
    • “The systems are typically used to aid with anesthesia in patients of all ages. They can be found in many hospitals and surgery centers across the country.” 

From the public health and medical research front,

  • MedPage Today tells us,
    • “Over the last two decades, U.S. neonatal mortality has generally declined, though not all leading causes of death followed this trend.
    • “There were 283,696 neonatal deaths from perinatal complications, with the top leading causes being disorders related to short gestation and low birth weight; maternal complications of pregnancy; and complications of placenta, cord, and membranes.
    • “Mortality due to slow fetal growth and fetal malnutrition increased annually, and mortality from maternal complications and bacterial sepsis of the newborn remained stable.”
  • Per Endocrinology Advisor,
    • “Individuals with celiac disease or thyroid disease have a significantly increased risk of developing type 1 diabetes (T1D), according to study findings published in Diabetes, Obesity and Metabolism.”
  • Per Pulmonology Advisor,
    • “Obstructive sleep apnea (OSA) is highly prevalent in those age 50 years and older, but manifests differently by race/ethnicity and sex, with the most rapid-eye-movement (REM) sleep respiratory events in Black women and the highest oxygen saturation (SpO2) levels in Mexican American women. These were among study findings published in the Annals of the American Thoracic Society.”
  • BioPharma Dive lets us know,
    • “A targeted lung cancer drug from Nuvalent led to tumor responses in about half of people who previously received at least one therapy like it, and 44% of those who had received at least two similar medicines, according to results from a clinical trial the company shared Tuesday.
    • “The study of Nuvalent’s drug, zidesamtinib, involves people whose metastatic non-small lung cancer has alterations in the gene ROS1. In addition to past treatment with so-called tyrosine kinase inhibitors, some participants had also received chemotherapy beforehand. Nuvalent will use the data to support a U.S. approval application for these “pre-treated” patients, which it expects to complete in the third quarter.
    • ‘Nuvalent is also studying zidesamtinib in ROS1-positive lung cancer patients who haven’t yet been treated and is discussing with the Food and Drug Administration the possibility of a “line-agnostic expansion” for the drug. A similar medicine from Nuvation Bio was approved this month for patients regardless of whether they’d previously been given a tyrosine kinase inhibitor.”
  • Per Healio,
    • “COPD mortality rates varied across North Carolina, often correlating with access to care and other risk factors, according to a pair of posters presented at the American Thoracic Society International Conference.
    • “What we’re looking at is your risk of COPD mortality based on your ZIP code,” Alexa M. Zajecka, MD, a first-year pulmonary critical care fellow at East Carolina University Medical Center, told Healio.”
    • “The researchers noted that although COPD is a leading cause of mortality and that North Carolina has one of the highest COPD-related death rates in the United States, there has been little research into its spatial clustering at the local level.” 
  • Gen Edge reports,
    • Amyotrophic lateral sclerosis (ALS) remains one of the most devastating and biologically elusive neurodegenerative diseases. Despite decades of research, its underlying mechanisms are still not fully understood. The condition presents a complex and highly variable interplay of genetic mutations, environmental factors, and cellular dysfunctions that differ widely across patients. This heterogeneity has slowed the development of effective diagnostics and therapeutics, leaving researchers to chase a moving target across a fragmented molecular landscape.
    • Yet much of ALS research still relies on static models—snapshots of a disease in motion. The condition unfolds dynamically, impacting multiple neural and non-neural cell types in real time. Capturing that progression requires lifelike systems that can replicate ALS as it unfolds in the human body. Without that, critical windows for intervention may remain hidden in plain sight.
    • “In a new study published in Cell Stem Cell titled, “An organ-chip model of sporadic ALS using iPSC-derived spinal cord motor neurons and an integrated blood-brain-like barrier,” researchers at Cedars-Sinai have developed a dynamic ALS model using patient-derived stem cells. This system may help uncover both the causes of ALS and new therapeutic targets.”
  • Per an NIH Intramural Research Program release,
    • It seems like every news report touting the health benefits of a daily glass of wine is soon followed by another that claims consuming any amount of alcohol harms health. While the jury is still out on this issue for younger individuals, a recent IRP study suggests that alcohol consumption may accelerate the typical age-related erosion of the cardiovascular system

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “It is becoming more difficult for insured and uninsured Americans to access affordable healthcare services, according to a new report from S&P Global Ratings.
    • “The United States spends more on healthcare services than any other country by any metric, according to the report. As of 2023, an individual could expect average out-of-pocket annual healthcare costs to run them an average of $6,159 annually and ancillary costs to account for approximately 6% of their average annual income before taxes.
    • “Efforts to rein in healthcare spending thus far have been mixed, and recent cost pressures could cause costs to climb further still, according to the report. Should headwinds continue, providers may be forced to make tough choices about what services they offer and where.”
  • and
    • “Ascension CEO Joseph Impicciche will retire at the end of the year, the nonprofit health system announced Tuesday.
    • “The health system’s board of directors has appointed President Eduardo Conrado to succeed Impicciche, effective Jan. 1, 2026.
    • “Ascension said it has been preparing for Impicciche’s departure for some time, adding the executive will be “actively engaged” in Conrado’s transition.”
  • Per BioPharma Dive,
    • “Perceptive Xontogeny Venture Funds and venBio Partners are contributing up to $40 million to a spinout of genetic medicine maker Lexeo Therapeutics to that will aim to advance drugs for heart conditions.
    • “The new biotech will focus on RNA-based medicines for genetically mediated cardiac conditions using a non-viral delivery method, according to a Tuesday announcement from Lexeo.
    • “Under the agreement, Lexeo will hold double-digit percentage equity in the new company, and could receive future milestone payments, royalties and opt-in rights to its programs.”
  • MedCity News informs us,
    • “Cohere Health, a clinical intelligence company, launched a new solution called Review Assist, which speeds up medical necessity reviews for health plans, the company announced on Monday.
    • “Boston-based Cohere Health provides AI-powered prior authorization solutions to help improve the relationship between payers and providers. The new tool is meant to help health plan clinical staff with prior authorization reviews, which are often extremely burdensome, according to the company. The typical process requires reviewers to analyze hundreds of pages of clinical records in order to determine if a patient procedure is medically necessary.
    • “Review Assist operates within existing utilization management workflows. It uses Cohere’s AI and large language models to analyze unstructured and structured clinical data and provide actionable insights for reviewers, as well as links to its source for this information. In addition, it has an AI chatbot that can answer questions for the reviewer and find additional insights.”
  • and describes Cigna Healthcare’s six new digital tools to improve the customer experience.
  • Per Beckers Health IT,
    • “Amazon One Medical and Edison, N.J.-based Hackensack Meridian Health continue to open clinics across New Jersey to expand access to primary care.
    • “The two organizations joined forces in 2023 to co-open the offices and make Hackensack a specialty care referral partner of Amazon One Medical.
    • “We hope to have 20 or maybe even more of these types of centers,” Hackensack CEO Robert Garrett said at a ribbon-cutting of the latest clinic June 17 covered by NJBiz. “It’s so well-needed. We’re going to be looking at different locations throughout the state of New Jersey in terms of where we think there’s a need for greater access to care.”
  • Modern Healthcare reports,
    • Current Health cofounder Chris McGhee has reacquired the at-home care company from Best Buy Co.
    • Financial details of the transaction were not disclosed.
    • “McGhee is returning as Current’s CEO. Former Chief Technology Officer Stewart Whiting and other former team members are also returning, according to a Tuesday announcement on the company’s website.”