Friday report

Uncategorized

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, Patient safety, U.S. Healthcare, Uncategorized–

Never forget.

The New York Times reports

  • “Mourners and dignitaries gathered this morning in Lower Manhattan to honor the thousands of people who were killed on this day 25 years ago, when terrorists crashed two airplanes into the World Trade Center, shaking America and the world. It took four hours for family members of the victims to read aloud the names of all of the nearly 3,000 people who lost their lives: Gordon M. Aamoth Jr.; Edelmiro Abad; Marie Rose Abad …
  • “Solemn ceremonies were also held at the Pentagon and in Shanksville, Pa., where the other hijacked planes crashed. At the Pentagon, President Trump spoke of American resilience: “Sept. 11 reminded us of the terrible power of hate,” he said. “The 25 years since have shown us the even greater power of the American spirit to endure and prevail and to win.”
  • “All four other living presidents attended the memorial in New York. Zohran Mamdani, the city’s first Muslim mayor, was also in attendance, despite a petition signed by thousands of people, including the family members of some victims, urging him to stay away.
  • “That ceremony began, as always, at 8:46 a.m., with a beat of silence honoring the moment when the first plane, American Airlines Flight 11, struck the North Tower. Five more silences marked the times when other flights crashed and buildings fell. But this year, a new, seventh moment of silence was observed, to mourn those who have died from cancer and other illnesses inflicted by the toxic dust they inhaled after the attacks.”

From Washington, DC,

  • Tammy Flanagan, writing in Govexec, tells us,
    • Every year, the anniversary of Sept. 11, 2001, brings back the same difficult truth: federal service is not always performed behind a desk, and risk does not always announce itself in advance. Sixty-nine federal employees were among those who died that day — including 62 at the Pentagon, three at the World Trade Center, three aboard Flight 93, one aboard Flight 77 at the Pentagon and one aboard Flight 175 at the World Trade Center. Many more reported for duty afterward to secure facilities, investigate the attacks, transport people, provide emergency assistance and help the country recover.
    • For their families, the lesson is not only one of remembrance. It is also a benefits lesson. If a civilian federal employee is injured, develops an occupational illness or dies because of federal employment, the Federal Employees’ Compensation Act may provide important protection.
    • FECA is the federal government’s workers’ compensation program for civilian employees, administered by the Labor Department’s Office of Workers’ Compensation Programs. It can pay for medical treatment, replace part of lost wages, provide compensation for permanent impairment and, in fatal cases, provide benefits to eligible survivors.
    • This is where many employees and families get into trouble: They know there are “benefits,” but they do not know which benefit applies, who administers it or what evidence is needed. A traumatic injury is generally tied to a specific incident during one workday or shift and is reported on Form CA-1. An occupational disease or illness develops over more than one workday or shift and is reported on Form CA-2. Wage-loss compensation is generally claimed separately, often with Form CA-7.
    • These distinctions are more than paperwork. They affect deadlines, agency responsibilities, medical documentation and how the claim is developed.
  • FEHBlog observation: While OWCP pays benefits before FEHB /PSHB plans for OWCP compensable illnesses and injuries, OWCP does not give the beneficiary an OWCP benefits ID card which would put the provider on notice to bill OWCP, not the FEHB/PSHB plan.
  • Healthcare Dive reports,
    • “The number of hospitals complying with price transparency rules is increasing. But more than half of facilities still aren’t posting full information about the cost of their services, according to the latest analysis from PatientRightsAdvocate.org.
    • “About 51% of U.S. hospitals aren’t fully complying with the rules, despite them taking effect more than half a decade ago, according to the patient advocacy group’s latest scorecard of 2,000 hospitals.
    • “Still, the roughly 49% of hospitals in compliance is up significantly from the last time PRA analyzed the industry in 2024, and is the highest rate since the group began tracking the issue in 2021. PRA chalked the improvement up to regulators stepping up enforcement.”
  • AHIP adds,
    • “Hospital spending makes up the largest share (40%) of health insurance premiums and continues to grow, now exceeding $1.6 trillion annually. One major driver of high hospital costs is that routine services are often reimbursed at substantially higher prices — sometimes up to 13 times more — in hospital outpatient departments (HOPDs) than in physician offices and other non-facility settings, even though the care is the same.” 
  • Beckers ASC Review tells us,
    • “Physician assistants and advanced practice registered nurses can now order every noninvasive colorectal cancer screening test Medicare covers, ending a long-standing physician-only requirement under a CMS coverage change.
    • “CMS authorized the expanded coverage in June when it finalized a decision memo revising the “Screening for Colorectal Cancer — Non-Invasive Biomarker Tests” national coverage determination, the American Academy of Physician Associates said in a Sept. 10 news release.
    • “The determination previously covered the tests only when a physician ordered them. CMS reopened it after new evidence emerged on stool-based RNA tests.
    • “PAs and APRNs may now order RNA-based stool tests, DNA-based stool tests, DNA-based blood tests and fecal occult blood tests.”
  • Beckers Hospital Review informs us,
    • “Johnson & Johnson will require 340B covered entities to submit claims-level data for its covered outpatient drugs starting Sept. 15, according to a notice the drugmaker sent to providers Sept. 4.
    • “Covered entities that don’t submit will receive at least two noncompliance notices and a notice of pricing suspension, with suspension beginning at least five business days after the final notice. J&J said 340B pricing will be restored within 10 business days once a covered entity submits compliant data.
    • “The policy applies to all covered entity types regardless of dispensing or administration location, inventory management system or payer coverage. J&J said it will continue to offer 340B pricing upfront at the time of purchase rather than moving to a rebate model, and that the policy supersedes claims-data provisions in a prior notice from February 2023.
    • “Covered entities must submit data within 45 days of a drug’s dispensation; a list of oncology, autoimmune and other specialty drugs, including Stelara, Darzalex and Tremfya, carries a 60-day window.” 

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

  • Federal New Network offers an interview with OPM Director Scott Kupor, and further reports
    • “Federal employees’ performance ratings will now be the top consideration during future reductions in force, as a final rule from the Office of Personnel Management takes full force this month.
    • “OPM’s final regulations, which became effective Sept. 2, mark a significant turning point in the way agencies develop RIF retention registers, which determine whether employees are retained, reassigned, demoted or separated during RIFs.
    • “Following the publication of the final rule in August, OPM detailed further expectations about the new system in guidance to agencies. During any future RIFs, agencies will have to rank employees using a point system directly tied to their performance ratings. An employee with a level 5 performance rating will receive seven points on the RIF register, while level 4 receives five points; level 3 receives three points; and levels 1 and 2 each receive zero points.
    • “Agencies will also place competitive service and excepted service employees on separate retention registers in any future RIFs. Within each list, employees will then be numerically ranked based on their performance levels, with points added for veterans’ preference. Tenure and seniority will be used only as tiebreakers between employees.”

From the Food and Drug Administration front,

  • The Pharmacy Times reports,
    • “The FDA approved leniolisib (Joenja; Pharming Healthcare) tablets for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in children aged 4 to 11 years who weigh at least 27 kg. The decision makes leniolisib the first FDA-approved treatment for children in this age and weight group with the rare genetic immune disorder.”
  • Cardiovascular Business relates,
    • “Emboline, a California-based medtech company, has received U.S. Food and Drug Administration (FDA) approval for its Emboliner Embolic Protection System. The device was built to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) procedures. This is seen as a way to reduce the risk of stroke, which clinicians have been battling since TAVR was first introduced, as well as other potential complications.
    • “We developed the Emboliner to address important unmet needs with existing embolic protection approaches for TAVR,” Scott Russell, president and CEO of Emboline, said in a statement. “We are excited to now be able to put the Emboliner in the hands of physicians so that they can offer a more comprehensive embolic protection solution for their patients. We are grateful to the clinical investigators whose partnership and feedback helped us reach this point.”
    • “The Emboliner device includes a self-expanding filter that covers all three cerebral vessels. The filter’s double-layer mesh captures debris without restricting blood flow in any way.
    • “Emboline plans on beginning its commercial launch of the newly approved device by the end of 2026.”
  • Fierce Pharma tells us,
    • “The FDA has delayed its approval decision for Exelixis’ oral kinase inhibitor zanzalintinib in combination with Roche’s Tecentriq for the treatment of patients with metastatic colorectal cancer (mCRC). 
    • “Exelixis explained in a Securities and Exchange Commission filing that the agency has asked for the extension while it awaits updated safety and efficacy data from the company. It means the biopharma should now expect a decision in March 2027 as opposed to the previous deadline of Dec. 3, 2026.”

No Surprises Act News

  • The American Hospital Association News tells us,
    • “The Departments of Health and Human Services, Labor, and the Treasury have added Physio Solutions, LLC as a new independent dispute resolution entity increasing the total to 17. IDR arbitrators help make payment determinations in disputes between providers, group health plans and health insurance issuers under the No Surprises Act.”
  • Beckers Payer Issues summarizes five other recent NSA updates for us.

From the judicial front,

  • Bloomberg Law reports,
    • “A federal judge blocked the Trump administration’s use of a question for federal job applicants that critics said amounted to a test of their political beliefs. 
    • “The Trump administration can no longer require thousands of government job seekers to say why the president’s policies are personally significant to them, and how they would further them if hired, according to a Friday ruling in the US District Court for the District of Massachusetts.” * * *
    • “While the ruling prevents the administration from using the question on job applications, O’Toole denied the unions’ request for a broader preliminary injunction barring the government from incorporating applicants’ answers or non-answers into hiring decisions. 
    • The case is AFGE v. Kupor, Office of Personnel Management, D. Mass., 25-13305-GAO, 9/11/26

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of September 11, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “COVID-19 activity is elevated and increasing nationally, but hospitalizations remain low.
    • “Rhinovirus/Enterovirus (RV/EV) and group A strep are increasing nationally.
    • “RSV activity and seasonal flu activity are low.”
  • The University of Minnesota’s CIDRAP adds,
    • “The number of confirmed US cases of measles has reached 3,294, fully 1,000 more than all of last year, the Centers for Disease Control and Prevention (CDC) noted in its weekly update today. 
    • “The total includes 160 new cases, most of them in Pennsylvania, the nation’s measles hot spot. The country has now seen five straight weeks of triple-digit increases.”* * *
    • “As noted in the data from the CDC map, cases in Wisconsin are also ramping up. In an update today, the Wisconsin Department of Health Services (DHS) confirmed 163 cases across the state so far this year. Four cases are new since September 8.” * * *
    • “Ohio this week confirmed 11 new cases, 133 total. In good news, Utah, which was a measles hot spot earlier this year, has gone more than three weeks without a confirmed case. Its case count stands at 518.”
  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention Sept. 10 released an advisory on a nationwide increase of reported human exposures to rabid or possibly rabid animals and rabies post-exposure prophylaxis administration errors. The CDC said it received 17% more rabies-related inquiries from July through August this year — including reports of mass exposure events — compared to the same period in 2025. The agency said that weekly pharmacy data as of Sept. 2 showed that utilization for the two rabies vaccines and two rabies immunoglobulins licensed in the U.S. increased by an estimated 33% and 76%, respectively, compared with the same period last year. The advisory includes recommendations for clinicians and healthcare facilities on rabies treatment and appropriate rabies PEP assessment and administration.”
  • The Wall Street Journal informs us,
    • “Public-health officials declared an end to a cyclosporiasis outbreak linked to iceberg lettuce that spread across the U.S. this summer.
    • “The outbreak has resulted in a total of 12,883 reported cases of the gastrointestinal food-borne illness across 21 states, the Centers for Disease Control and Prevention said Friday.
    • “Federal health officials have linked the outbreak to shredded iceberg lettuce from Taylor Farms, a major supplier of fresh produce to retailers such as Walmart, Costco Wholesale and Amazon.com’s Whole Foods Market, as well as restaurant chains including McDonald’s and Yum Brands’ Taco Bell.
    • “The CDC said the contaminated lettuce linked to the outbreak is no longer available in stores or restaurants, and the products’ best-by dates have passed. Recent infections linked to the outbreak have declined, with fewer than two infections per day on average in August compared to a peak of more than 1,000 daily infections, the CDC said.”
  • Health Day points out,
    • “Talking to a counselor before major surgery might boost seniors’ recovery following a procedure, a new study says.
    • “Mental health coaching before surgery can help reduce seniors’ risk of post-surgery anxiety and depression, researchers reported Sept. 9 in JAMA Network Open.
    • “The time around surgery is a window of both risk and opportunity,” lead researcher Joanna Abraham said in a news release.
    • “The stress of surgery can worsen anxiety and depression symptoms and affect patients’ recovery and overall health, but it also offers a critical opportunity to identify these concerns proactively and connect patients with the support they need,” said Abraham, a professor of anesthesiology at Washington University School of Medicine in St. Louis.”
  • Nature notes,
    • “Injected vaccines can raise an army of antibodies in the blood to stave off major illness, but don’t prevent infection at the points where respiratory viruses enter the body. Researchers hope that nasal vaccines could bolster protection at the moist mucosal barriers that line the respiratory tract, which could enable a person to rapidly ward off pathogens and prevent them from spreading a virus to others. A long line of failures demonstrates that developing a mucosal vaccine is a challenging task, but their promise is still enough to maintain commercial interest.”
  • Per Beckers Clinical Leadership,
    • “The rise of GLP-1 medications is one of the most consequential changes in obesity care in decades. Not surprisingly, bariatric surgery is feeling the impact. As patients gain access to powerful medications such as semaglutide and tirzepatide, fewer are immediately choosing an operation. The trend is real, but [as explained in the article,] the conclusion that GLP-1s will simply replace bariatric surgery misses the larger story.”

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

  • Beckers Hospital Review reports,
    • “Septicemia is the most expensive condition treated in hospitals, amounting to $60 billion in annual costs, a Healthcare Cost and Utilization Project report found. 
    • “The report, published February 2026, used 2022 data from the Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project on hospital costs of inpatient stays in nonfederal acute care hospitals. Using the 2022 HCUP National Inpatient Sample, the report found the distribution of costs by primary expected payer and the conditions that accounted for the largest percentage of payer’s hospital costs. Hospital charges were converted to costs using HCUP cost-to-charge ratios. Payers included Medicare, Medicaid, private insurance and self-pay/no charge. 
    • “The report found: 
      • “The aggregate hospital costs for 32.9 million hospital stays totaled $548.5 billion.
      • “The 20 most expensive conditions account for 46.8% of aggregate hospital costs in 2022, and amounted to 43.1% of all hospital stays.
      • “Septicemia accounted for 10.9% of aggregate costs for all hospital stays in 2022 across all payer groups — more than three times higher than the next most expensive condition: liveborn infants which accounted for 3.6% of aggregate costs.
      • “Among the most expensive conditions, liveborn infants were the most common reason for hospitalization at 10.6% of all hospital stays, followed by septicemia at 7.4%, heart failure at 3.3% and COVID-19 at 2.5%.
      • “Circulatory system conditions were the most frequent of the top 20 diagnoses for Medicare, private insurance or self-pay/no charge.
      • “Pregnancy and childbirth conditions were the most frequent among the top 20 conditions for Medicaid.”
  • and
    • “More than 150 independent rural hospitals across eight states have banded together into clinically integrated networks over the past three years, betting that shared scale, data and negotiating leverage can keep them out of the arms of consolidating systems and payers.
    • “The newest addition is the Show-Me High Value Network, a Missouri coalition of 23 independent hospitals that collectively serve more than 1.8 million residents across urban, rural and underserved communities. It joins a fast-growing map of rural high-value networks that includes: 
    • “Cibolo Health, a Texas-based consultancy that specializes in building rural hospital collaboratives, manages seven of the networks, including those in North Dakota, Minnesota, Ohio, Montana, Nebraska, Wisconsin and Kansas.”
  • and
    • “St. Louis-based Mercy recorded an operating income of $500.8 million (4.5% margin) for fiscal year 2026, up from $21.4 million (0.2% margin) in fiscal 2025, according to its Sept. 11 financial report.”
  • and
    • “Hershey, Pa.-based Penn State Health reported a $131.2 million operating gain on $5 billion in revenue for the fiscal year ended June 30, a significant improvement from the prior year, according to its audited financial statements.”
  • Beckers Payer Issues relates,
    • “Ujjwal Ratan has joined UnitedHealth Group’s consulting and analytics division, Optum Insight, as chief AI officer.
    • “In a Sept. 10 LinkedIn post, Mr. Ratan said his role is to enable Optum Insight to operate as a connected agentic network in healthcare.”
  • and
    • “Taft Parsons III, MD, is leaving his role as CVS Health’s chief psychiatric officer.
    • “Executives decide to try something different, and organizational structures and jobs change,” he said Sept. 11 on LinkedIn. “I’ve benefited from those changes more often than not, and I understand this is simply my turn to find another path toward improving healthcare.”
  • Beckers ASC Review tells us,
    • “National Healthcare Properties completed the sale of 30 primarily multi-tenant outpatient medical facilities for $198 million.
    • “The transaction represents the first tranche of its previously announced sale of 86 outpatient medical facilities for approximately $528 million, according to a Sept. 10 news release from the company. The remaining 56 facilities are expected to close in the fourth quarter of 2026.”
  • The Wall Street Journal points out,
    • “France’s Ipsen IPN is considering building a production site in the U.S., joining other European drugmakers looking across the pond when planning new investments.
    • “Discussions are ongoing,” Ipsen Chief Executive David Loew said in an interview. “No decision has been reached yet on exactly when, but this is certainly something that we are taking into consideration.”
    • “Loew said the next big plant the company builds will manufacture either its Dysport drug—a rival to AbbVie’s ABBV Botox—or a next-generation medicine called corabotase that is still under development.
    • “Many of the world’s top pharmaceutical companies pledged to make multibillion-dollar investments to bring manufacturing and other operations to the U.S. over the coming years, in a bid to mitigate tariff threats by the Trump administration. In addition to big companies like AstraZeneca and Roche, smaller drugmakers like Belgium’s UCB and Australia’s CSL also plan to invest in new U.S. facilities.”
  • Fierce Pharma lets us know,
    • “Both Novo Nordisk’s Wegovy pill and Eli Lilly’s Foundayo saw their highest total prescriptions so far over the past week as the companies’ oral obesity battle continues to play out.  
    • “According to IQVIA data cited by Citi, the Wegovy pill reached an approximate 183K total scripts for the most recent reporting period, versus 181K the week prior. Foundayo, for its part, climbed nearly 8% to reach 47.5K scripts. Citi analysts emphasized that IQVIA may still be missing some Foundayo prescriptions made through telehealth channels. 
    • “Meanwhile, using the last four weeks as a guide, total GLP-1 prescriptions have increased by 5.4%, compared to a 6.8% decline the prior year, the Citi team said. Citi analysts attributed the 12-percentage-point swing to the expansion of oral GLP-1 therapies, which is likely broadening access to the class and drawing in new patients.  
    • “Across the broader landscape, Lilly’s tirzepatide currently holds a nearly 57% share of the total GLP-1 market, compared to around 49.5% last year, while Novo’s semaglutide has stayed relatively flat at a 37% share, the analysts added.”  

Monday report

David Ermer–Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • Federal News Network reports,
    • “House lawmakers return to Washington on Monday with a short to-do list after five weeks back in their home districts. The first order of business is likely a vote on a stopgap spending bill designed to keep the federal government fully funded through early December, removing the possibility of a shutdown before the midterm elections.” * * *
    • “House Speaker Mike Johnson is expected to tee up the funding bill early in the week. The bill underwent some significant changes in the Senate, which made it more palatable for Democrats. It delays a proposed rule from the Office of Management and Budget that would give political appointees more power over the distribution of federal grants. It also includes language to ensure the administration can’t transfer funds to the Border Patrol.
    • “But a provision that delays for one month a federal ban on intoxicating hemp THC products has prompted criticism from many GOP lawmakers. As a result, GOP leaders will likely place the bill on a fast-track process that avoids a separate procedural vote. Suspension bills require a two-thirds vote to pass, meaning a significant number from both parties need to support the measure for it to pass and advance to Trump’s desk.
    • “Lawmakers are anxious to avoid the possibility of a shutdown as voters weigh their options going into November. The funding bill passed by a 90-6 vote in the Senate, showing that lawmakers from both political parties want to avoid a repeat of the two historic shutdowns that occurred this past year.”
  • The Wall Street Journal relates,
    • The Trump administration reached agreements for most-favored-nation drug pricing with nine pharmaceutical companies, including Teva Pharmaceuticals, Astellas Pharma, and BridgeBio.
    • The agreements provide for all state Medicaid programs to pay prices for prescription drugs that match the lowest prices paid by other developed nations, the White House said Monday, adding that the agreements also guarantee MFN pricing for all new medicines the companies bring to market.
    • The U.S. has now reached 26 such deals covering 89% of the branded drug market, the White House said.
    • The nine companies—which include Alcon, BeOne Medicines, CSL, Kyowa Kirin, Sun Pharma, and UCB—also agreed to collectively commit $19.6 billion to manufacturing in the U.S. in the near term, the White House said. Some of the companies also agreed to donate active pharmaceutical ingredients to a federal stockpile.
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), today announced on Overdose Awareness Day that it has awarded $77 million in new grant funding to strengthen substance use prevention, treatment and recovery, community mental health, suicide prevention, and crisis services. The announcement comes as National Substance Use Primary Prevention Month draws to a close, with more than $22 million of the funding supporting critical substance use prevention efforts in communities.
    • “Every American deserves the chance to live free from addiction and the devastation of untreated mental illness,” said HHS Secretary Robert F. Kennedy, Jr. “President Trump’s Great American Recovery is taking on these crises at their roots. We are investing in prevention, expanding access to effective treatment, strengthening crisis response, and helping communities intervene before tragedy strikes. Our goal is clear: save lives, restore families, and help more Americans achieve lasting recovery and better health.”
  • The Census Bureau tells us,
    • “The share of the world population age 65 and older is projected to nearly double from 10.5% to 19.6% between 2025 and 2060, according to a new report released today by the U.S. Census Bureau.
    • “An Aging World: 2025 finds that the global population is aging faster than ever before. Between 2020 and 2025, the proportion of the population age 65 and older exceeded the population age 5 and younger for the first time in recorded history.
    • “In 2025, the United States ranked the 48th oldest country out of 227, with 18.9% of its population age 65 or older. By 2060, older adults are projected to make up 23.4% of the U.S. population. Yet the United States will fall to 110th place globally because other countries are aging much more rapidly.”

From the Food and Drug Administration front,

  • MedTech Dive tells us,
    • “Boston Scientific plans to stop selling certain angiographic catheters after a manufacturing problem led the company to pull the devices from the market. 
    • “The medical device manufacturer sent a letter to customers last week instructing them to immediately stop using or distributing all Imager II Angiographic Catheters due to an issue that can increase the risk of the tip detaching. The Food and Drug Administration posted an early alert on Friday.
    • “Boston Scientific had reported two serious injuries associated with the problem as of July 16.”
  • Fierce Pharma informs us
    • “These are heady days for PharmaEssentia, a biotech that got its start 23 years ago in Taiwan, went public 10 years later and is now deepening the foothold of its first commercial product, Besremi.
    • “There’s a lot of electricity in the air in the organization right now,” Samuel Lin, PharmaEssentia’s Head of U.S. Global Operations, said in an interview with Fierce. “Sometimes you have to stop and pinch yourself a little bit.”
    • “The excitement ramped up on Monday as the FDA signed off on a key label expansion for Besremi, endorsing it as a treatment for the rare bone marrow disorder essential thrombocythemia (ET). 
    • “The label specifically covers adults with ET regardless of their genotype or disease status, including newly diagnosed patients who haven’t received cytoreductive therapy, according to an Aug. 31 release.”

From the public health and medical / Rx research front,

  • Healio reports,
    • “The United States’ death rate likely dropped to a record low last year, according to provisional CDC data.
    • “The National Center for Health Statistics (NCHS) released the report, which offers an early estimation of the deaths that occurred in 2025, in late July.” * * *
    • “The new data show that, in 2025, there were 3,094,593 deaths, and the overall mortality rate was 689.2 per 100,000 people — 4.6% lower than the 2024 rate of 722.1 per 100,000 people. The leading causes of death remained the same, though, with heart disease, cancer and unintentional injuries in the top three spots.
    • “In the 2025 provisional data, the age-adjusted mortality rate was 582.9 for women and 811.1 for men. It dropped for every age group. Additionally, the age-adjusted mortality rates were the highest in the Black non-Hispanic population at 869 per 100,000 and lowest for “the multiracial non-Hispanic population” at 187.3 per 100,000.” * * *
    • “Although nothing is confirmed, some experts have pointed to the decline in overdose deaths as a reason for the lowered mortality rate.”
  • The New York Times points out,
    • “It’s been two months since Ericka Ratliff, 55, fell ill with cyclospora, yet she is still dealing with sharp abdominal pains and sudden urges to go to the bathroom. “It’s very unpredictable,” she said, as if “my stomach is just extremely angry.”
    • “Ms. Ratliff, who lives in Adrian, Mich., has tried following a bland diet and eating small, frequent meals to quell her symptoms, but she said she worried that her gut would “never be the same again.”
    • “Research suggests that roughly 10 to 20 percent of people who get intestinal illnesses from bacteria, viruses or parasites will end up having symptoms, like diarrhea and abdominal pain, that can last for months or even years. This condition is called post-infection irritable bowel syndrome.
    • “It’s too soon to know whether Ms. Ratliff is dealing with post-infection I.B.S. But after the recent surge in cyclospora infectionsin the United States, along with other foodborne illness outbreaks linked to jalapeños, sprouts, frozen blueberries and more, some gastroenterologists worry that they may soon be seeing more patients with the condition.
    • “I’m expecting our clinics to be getting inundated,” said Dr. Baha Moshiree, a gastroenterologist and professor of medicine at Wake Forest University School of Medicine in North Carolina.”
  • and
    • “After the unpredictability of last year’s flu season, when a new variant of the virus spread widely and rapidly, infectious disease experts are hoping for a tamer fall and winter this year.
    • “Scientists look to countries like Australia, in the Southern Hemisphere, for clues about how the flu will play out. This year, the flu seems to be circulating in those regions at relatively moderate levels, and this year’s flu shots appear well matched to combat the virus. But it’s uncertain whether that will change as flu season unfolds in the Northern Hemisphere.
    • “I’m cautiously optimistic,” said Dr. Scott Roberts, an assistant professor of infectious diseases at the Yale School of Medicine, emphasizing “cautiously.”
    • “Doctors are also reassured that there are new options for vaccination against the flu, and that at-home tests have entered the market in recent years.”
  • Health Day relates,
    • “For people with asthma or COPD, reaching for a rescue inhaler too often may be a warning sign — not just for their lungs, but for their heart.
    • “It’s estimated nearly 1 in 5 asthma patients and 1 in 3 COPD patients overuse these products.
    • “Researchers analyzed real-world health data from more than 280,000 asthma and COPD patients in Belgium.
    • “They found frequent use of short-acting reliever inhalers, also called bronchodilators, was associated with a higher risk of cardiovascular disease and death, including heart failure, heart attack and ischemic stroke.”
  • and
    • “Integrated cognitive behavioral therapy (CBT) is effective for primary care patients with depression, according to a study published in the June issue of The Lancet Primary Care.
    • “Debbie Tallon, from University of Bristol in the United Kingdom, and colleagues evaluated the clinical effectiveness of integrated therapist-delivered CBT (consisting of combined one-to-one CBT delivered by instant messaging with an accredited CBT therapist and online resources) in reducing depressive symptoms for primary care patients. The analysis included 334 adults meeting depression criteria, randomly assigned to nine integrated CBT sessions through the INTERACT therapy platform or usual care.
    • “The researchers found that at six months, the mean Beck Depression Inventory score was significantly lower in the intervention group versus control (22.5 versus 27.4; adjusted difference in means, –4.4; effect size, 0.43). There were more adverse events in the intervention group (33 versus 21 in the control group), including serious adverse events (12 versus two in the control group). Self-harm (six patients) and referrals to a mental health team (six patients) were the most common. Of the serious adverse events, none were definitely or probably related to the intervention.”
  • The American Medical Association lets us know “what doctors want patients to know about sodium consumption.” 
    • Sodium isn’t just lurking in heavily salted snacks. Two physicians discuss where sodium resides and which choices to make to avoid it in excess.
  • tctMD tells us,
    • “People over age 70 with no history of cardiovascular disease see dramatic reductions in major adverse cardiovascular events when newly prescribed statin therapy for primary prevention, according to results of the STAREE trial.
    • “Compared with those given placebo, patients taking 40 mg of atorvastatin once daily had a 30% lower incidence of CV death, nonfatal MI, stroke, or coronary revascularization (6.0% vs 8.3%; P < 0.001) over the 6-year study period. There was, however, no difference between groups in the incidence of disability-free survival, defined as a composite of death from any cause, dementia, or persistent physical disability.
    • “In a media briefing here prior to the presentation at the European Society of Cardiology Congress 2026, lead author Sophia Zoungas, MBBS, PhD (The George Institute for Global Health, Sydney, Australia),  said the data answer important questions about the safety and efficacy of statins in older people.”
  • MedPage Today informs us,
    • “Nearly half of adults who started semaglutide (Wegovy) for obesity management stopped treatment within a year, a Danish cohort study showed.
    • “Among 157,822 first-time semaglutide initiators without diabetes, 49% discontinued treatment by 12 months, defined as a prescription gap of 60 or more days. Discontinuation steadily increased from 13% by 3 months, to 27% by 6 months, and 39% by 9 months.
    • “However, one in four discontinuers restarted therapy within 3 months, Aurélie Mailhac, MSc, of Aarhus University Hospital in Denmark, and co-authors reported in JAMA Network Open.
    • “These findings may reflect frequent temporary treatment interruptions or self-adjusted dosing below guideline-recommended levels,” they wrote.”
  • Per BioPharma Dive,
    • “Novartis and Bristol Myers Squibb have paused multiple trials evaluating their respective cell therapy programs against autoimmune conditions after observing inflammatory side effects in testing, the companies confirmed Monday afternoon.
    • “Novartis, which is testing a personalized cell therapy called rap-cel in a handful of autoimmune studies, found three cases of immune effector cell-associated hemophagocytic syndrome, a rare and possibly life-threatening reaction. The company said it initiated holds on those trials — which are evaluating rap-cel in lupus, myasthenia gravis, multiple sclerosis and more — on Aug. 24. Novartis is “engaged” with regulators and is reviewing the findings, according to a company spokesperson. 
    • “The temporary halt will allow for a more comprehensive review of the evolving clinical and safety data across the program,” the spokesperson wrote in an email to BioPharma Dive.”

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

  • Beckers Payer Issues reports,
    • “High deductible health plans may reduce how much people spend on healthcare in the short term, but they don’t appear to slow the rate at which that spending grows over time, according to a study of more than 324,000 commercially insured members published in the International Journal of Health Economics and Management.
    • “The study, published in May, was led by researchers at the University of Pennsylvania’s Wharton School and included co-authors from Analysis Group, the Elevance Health Public Policy Institute and Georgia State University.”
  • Beckers ASC Review adds,
    • “From a jointly built AI documentation tool with Abridge to three distinct growth partnership models, Oakland, Calif.-based Kaiser Permanente has spent the past few months navigating expansion, labor tension and legal exposure.”
  • Fierce Healthcare relates,
    • “It’s been nine months since the opening of the country’s largest all-electric acute care hospital in Irvine, California.
    • “UCI Health was already in the planning stages of its new Irvine campus when the University of California (UC) established a policy that no new or renovated buildings could burn fossil fuels for space and water heating. 
    • “The health system may have gotten an exemption as a healthcare facility. But leadership decided to push the boundaries of hospital design by going all-electric. The ambitious plan was not purely a cost-saving strategy. According to Tony Dover, UCI Health’s energy management & sustainability officer, it was a moral imperative.
    • “We were doing it because it was the right thing to do,” Dover told Fierce Healthcare. “It was for decarbonization, resilience, and we’re mitigating our pollution for the community that we serve.”
  • Healthcare Dive notes,
    • Name: Michael Grasher
    • Previous title: Chief financial officer, IFG Companies
    • New title: Chief financial officer, Teladoc Health
    • Teladoc has appointed Grasher as its CFO effective immediately, the telehealth firm announced Monday. He’s succeeding Mala Murthy, who departed in November after six years for another opportunity.
    • Grasher has more than three decades of experience across insurance and financial services, including more than 12 years as a chief financial officer.
  • Beckers Hospital Review tells us,
    • “Contract breaks between major health systems and certain Medicare Advantage insurers are continuing in 2026. Providers [listed in the article] dropping plans often cite prior authorization denials and slow reimbursement; in other cases, insurers are terminating the contracts themselves.
  • and
    • “Charlotte, N.C.-based Advocate Health recorded an operating income of $775.3 million (3.8% operating margin) during the first six months of 2026, down from $824.4 million (4.4% margin) during the same period last year, according to its Aug. 27 financial report.”
  • and
    • “Burlington, Mass.-based Tufts Medicine’s operating margin fell to -3.4% through the first nine months of fiscal 2026, compared with -2.3% during the same period a year earlier, as the health system’s CEO and CFO prepare to step down.
    • “Tufts reported an operating loss of $79.5 million on $2.4 billion in revenue for the nine months ended June 30, according to financial documents filed Aug. 28. That compares with an operating loss of $50 million on $2.2 billion in revenue during the same period in fiscal 2025.”
  • Beckers Clinical Leadership informs us,
    • “Internal medicine is the most in-demand physician specialty and locum tenens specialty, Doximity found.
    • “Doximity, a digital platform for U.S. medical professionals, released its 2026 Physician Compensation Report Aug. 25. The report surveyed physicians in June on how AI is changing physician careers and pay, and included salary data from the platform’s dataset of more than 23,000 responses collected in 2025, according to a company news release. To find the most in-demand jobs, the company analyzed tens of thousands of job postings across its network in 2025.
    • “Doximity also found the specialties with the highest demand for locum tenens. This is an increasingly popular way for physicians to supplement their income and practice with more flexibility, according to the report. 
    • “Three of the four most in-demand specialties and locum tenens were primary care specialties. Eight specialties appeared on both lists [found in the article]. 
  • and
    • “Three out of four physicians say they would accept lower pay in exchange for greater autonomy or work-life balance, a preference that has remained remarkably consistent over the past four years, according to a Doximity poll of nearly 1,000 physicians conducted in July 2026.
    • “The share of physicians willing to trade compensation for autonomy or work-life balance has held steady at 71% in 2023, 75% in 2024, 77% in 2025 and 76% in 2026. The preference is significantly stronger among women physicians at 86% compared with 71% of men, which has slightly widened compared to the prior year.”
  • The Wall Street Journal lets us know,
    • “Eli Lilly remains on a shopping spree, agreeing to pay up to $2.875 billion in cash for biotechnology company Merida Biosciences in a deal that bolsters the drugmaker’s immunology portfolio.
    • “Eli Lilly on Monday said privately held Merida is advancing a new class of precision therapeutics for serious autoimmune and allergic diseases, with its lead program in Phase 1 development for Graves’ disease and thyroid eye disease.
    • “The Merida deal continues a spate of acquisitions by the Indianapolis company, which is flush with cash from its market-leading weight-loss-drug franchise.”
  • The New York Times adds,
    • “Revolution Medicines set a sticker price of about $480,000 a year, or $663 a tablet, for its new pancreatic cancer drug — a cost that would have once been unthinkably high.
    • “Today, such prices are routine for cancer drugs.
    • “One cutting-edge CAR-T therapy now goes for $600,000 for a one-time infusion. A competitor, given the same way, is listed at $550,000. A daily pill for gastrointestinal cancer has a sticker price of $520,000 a year. A twice-daily pill for leukemia? It’s $430,000 a year.
    • “In 2024 alone, nine cancer drugs were approved and then introduced with sticker prices above $400,000 annually, according to a tally by the Institute for Clinical and Economic Review, which evaluates the value of medicines.
    • “That these prices have become commonplace would have been hard to imagine two decades ago, when even the prospect of a $100,000-a-year cancer drug evoked fierce criticism.
    • “But since then, cancer drug prices have steadily increased, with few constraints beyond what a company thinks the market will bear. The expense is borne by government programs like Medicare, employers, patients and Americans who pay taxes and health insurance premiums.”

Wednesday report

David Ermer–FDA, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

Quick Hits

  • Reuters adds,
    • “About 14% of employers in the United States have already or plan to drop GLP-1 drugs in 2027, as companies see ​rising healthcare costs, according to a survey released on Tuesday by the Business Group ‌on Health.
    • “Healthcare costs are set to increase 9.2% if employers do not make changes to manage costs in 2027, up from 8.5% in 2026, the group said. Two-thirds of employers surveyed said they saw rising utilization of ​the drugs.”
  • Healthcare Dive reports,
    • “The federal process for insurers and providers to settle disputes over out-of-network bills appears to be dramatically adding to U.S. healthcare spending, fueling calls for reform.
    • “That mechanism, set up by the No Surprises Act, has generated more than $22.4 billion in extra costs over just four years, according to new estimates from Georgetown University. That’s a significant acceleration from researcher’s past estimates of $5 billion in extra costs over the dispute resolution process’ first two years.
    • “But dispute volumes and total awards have continued to increase since — a worrying finding, given costs could push premiums up. The researchers urged policymakers to revisit the NSA.
  • The Wall Street Journal reports,
    • “For four decades, cancer researchers fought to disable a stubborn mutation that made pancreatic cancer a death sentence—to little avail. 
    • “Now, doctors have a medicine that targets the mutation. The Food and Drug Administration’s approval of the drug from Revolution Medicines on Wednesday marks a milestone in treatment of one of the most intractable kinds of tumors. 
    • “This is life-altering,” said Carla Kurkjian, an oncologist at Mercy Hospital in Oklahoma City, who wasn’t involved in the studies. “Not just for patients, as far as helping them extend their lives beyond anything we’d ever seen, but for us as physicians, to be able to have a different conversation than we’ve had for so long.”
    • “The drug, called Rasonque, helped subjects in a late-stage study live more than 13 months, nearly twice as long as those on chemotherapy alone. When presented at the world’s largest gathering of cancer researchers last spring, the results drew a nearly minute-long standing ovation.” 
    • “Yet the drug does have side effects, including a harsh rash across the body and gastrointestinal issues. Former Nebraska Sen. Ben Sasse, who went public in the spring with what he described as a significant reduction in his tumors while in a clinical trial of the drug, appeared on television with his face covered in red blotches.
    • “RevMed said the drug will cost $39,800 a month, or more than $477,000 a year.
    • “Wall Street expects Rasonque, which was approved for use in patients for whom other treatments failed, to be a big seller. The drug could generate more than $20 billion in annual sales, according to pharmaceutical commercial intelligence firm Evaluate, if the drug proves to work safely in earlier stages of the disease and with different types of cancers.”
  • The New York Times adds,
    • “The Food and Drug Administration’s approval on Wednesday of a new drug for pancreatic cancer marked the end of a long quest to develop a medicine that can hit one of cancer’s most elusive targets.
    • “Researchers hope the new drug is just the beginning, opening a new chapter in treatment for a range of cancer types.
    • “At least 79 drugs that take a similar approach are being tested in 238 clinical trials worldwide, according to one tally by academic researchers.
    • “Large drugmakers like Eli Lilly, Pfizer, Amgen and AstraZenecaare among the companies racing to develop their own medicines that work like the new drug, daraxonrasib, which is made by Revolution Medicines and will be sold as Rasonque.”
  • STAT News notes,
    • “The newer shingles vaccine has been turning heads since its link to lower dementia rates was reported two years ago. Now the same research team behind that observation has found an association between receiving the Shingrix shot and a reduced risk of heart disease.
    • “There have been signals before of cardiovascular benefits in people who got the newer, recombinant vaccine to prevent shingles, a painful, often serious flare-up in older people of the chickenpox virus from childhood. Those who got Shingrix were less likely than unvaccinated people to have heart attacks, strokes, or heart failure.” * * *
    • “Although the benefits are relatively small on an individual basis, millions of people receive shingles vaccination, meaning that even a small cardiovascular benefit could translate into a substantial number of cardiovascular events prevented at a population level,” Mark Russell, clinical senior lecturer and consultant rheumatologist of King’s College London, said in a statement shared by the Science Media Centre.” 

Weekend Report

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

Simplicity is a virtue.

From Washington, DC

  • The House of Representatives is on a District work break until August 31, 2026, and the Senate is on State work break until September 14, 2026.
  • The Western Journal discusses the federal government’s efforts to stop paying benefits to beneficiaries who have passed away. FEHB and PSHB plans, as private entities, cannot use the federal government’s Do Not Pay system. It obviously would be helpful if OPM used the HIPAA 820 enrollment roster transaction which would allow FEHB and PSHB plans to reconcile premiums payments with individual enrollees. The HIPAA 820 tranaction has been in use since 2012, and FEHB and PSHB plans are reportedly the only plans serving large employers that do not benefit from the HIPAA 820.

From the public health and medical / Rx research front

  • IFL Science reports,
    • “Currently, there are more COVID cases in [California] than there were during the winter season. It is thought that this is being driven by the mutated “cicada” variant.
    • “Known more formally as BA.3.2, the variant was first identified in southern Africa in 2024. Since then, it has spread around the world, having now been detected in least 32 countries, including Australia, Germany, and the US.
    • “The variant has caught the attention of virologists and researchers because it has more than 70 spike mutations compared to the original wild-type virus.” * * *
    •  “Our summer peak was much higher in 2025 than it was in the winter,” Dr. Erica Pan, director of the California Department of Public Health and the state public health officer, said in a briefing.
    • “Summer is really the bigger peak. So if you do have patients or loved ones who have not gotten the ’25-’26 vaccines, it is still effective and highly recommended, given this surge we’re starting to see.”
    • “It seems that the shift from bigger winter to summer peaks started to occur around 2024. While so far this has been more noticeable in California, there is also evidence for this trend emerging right across the country.
    • “Why it is happening, and if the trend will continue, is still unknown.
    • “What is known, however, is that the COVID vaccines are safe and effective. A newly formulated shot is expected in the coming fall, but those at an increased risk of the disease can get a booster shot earlier if needed.”
  • The American Medical Association lets us know,
    • “One case of measles is concerning. Thousands are a warning.
    • “Our nation is experiencing the largest measles resurgence in decades—even though we have had a vaccine for more than 60 years. This year’s case count has already surpassed the total reported in all of 2025, making 2026 the worst year for measles our country has experienced in decades.
    • “For many physicians, measles is something they have read about rather than seen firsthand. That is a testament to the success of vaccination. It is also a reminder that vaccine-preventable diseases return when vaccination rates decline.
    • “For all clinicians, this resurgence is more than a public health statistic. It is a reminder that conversations about vaccination remain among the most important forms of preventive care we provide”
  • PBS News adds,
    • “The nationwide cyclospora outbreak is very likely a result of sewage contaminationin the food supply, according to scientific researchers and public health officials.” * * *
    • “As floods and droughts occur routinely across the U.S. and around the world, sewage may overflow into bodies of water or be used directly on crops. That increases the risk that diseases, including protozoa such as cyclospora, which are transmitted through ingestion of fecal matter, may spread through food and water supplies.
    • “And because cyclospora oocysts mature in outdoor heat, it is possible that increasing temperatures, such as heat domes, could speed up their maturation, exposing more people to the infectious form of the parasite.
    • “Modern technology and techniques are capable of monitoring water quality, detecting harmful pathogens and eliminating them. Expanding monitoring of wastewater for protozoan diseases and other dangers can help prevent outbreaks and slow the spread of disease from sewage-contaminated water in the future.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Memories can survive even after the brain temporarily loses more than half of its synaptic connections, according to the results of a study in mice that challenge the long-held view that long-term memories depend on stable individual synapses. The researchers, headed by a team at Okinawa Institute of Science and Technology (OIST), and including teams at the University of Tsukuba, Exploratory Research Center on Life and Living Systems (ExCELLS), and National Institutes of Physiological Sciences, used a mouse model of artificial hibernation to examine structural mechanisms underlying memory retention.
    • Their findings indicate that memory may be preserved not through individual synapses, but through resilient patterns of neural architecture, including specific clusters of connected synapses that remain protected during widespread hibernation-associated brain remodeling. These preserved structural motifs could act as a “core memory trace,” allowing the brain to rebuild functional networks after major disruptions.
    • “Research lead Kazumasa Tanaka, PhD, head of OIST’s Memory Research Unit, said, “Previously, synaptic strengthening was thought to be key to memory recall, and that stronger synapses with larger dendritic spines were fundamental to long-term memory retention. Here, we show that not every synapse matters, and demonstrate instead the vital importance of engram architecture. The study indicates that small clusters of engram-engram synapses are preserved to enable accurate recall even after hibernation.”
    • “Tanaka is senior and corresponding author of the team’s published paper in Science, titled “Artificial hibernation reveals synaptic engram architecture associated with memory retention.”
  • Health Exec points out,
    • “Higher doses of semaglutide were associated with significantly lower cardiovascular risk in patients with pre-existing cardiovascular disease, while the amount of weight loss achieved did not appear to predict subsequent cardiovascular protection, according to a large real-world analysis. This was according to a new article in the journal Nature.[1]
    • “The findings raise the possibility that semaglutide’s cardiovascular effects extend beyond weight reduction. This adds to growing clinical data showing how GLP-1 drugs are having a positive impact on patient health separate from weight loss outcomes.
    • “The degree of weight loss surprisingly did not correlate with cardiovascular protection as measured by all-cause mortality or multiple individual incident disease diagnoses,” explained lead author Karthik Murugadoss, a data scientist with nference and its Metabolism Agentic Intelligence Atlas (MAIA) initiative. “In a direct comparison of semaglutide to other anti-diabetic medications, semaglutide was associated with reduced rates of multiple cardiovascular endpoints after treatment initiation.”
    • “He said the findings suggest a cardioprotective role of semaglutide which may be related to attained dose, but is not explained simply by the amount of weight loss achieved while on therapy.”

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

  • The Wall Street Journal reports,
    • “Patients, families and healthcare professionals are turning to AI tools to help identify rare and hard-to-diagnose diseases.
    • “A study published in a JAMA journal found that two AI chatbots suggested the correct rare-disease diagnoses more often than doctors did.
    • “Doctors and researchers caution that AI tools still make mistakes and are limited by a lack of digitized data for rare conditions.”
  • Beckers Payer Issues relates,
    • “Point32Health, the parent organization of Harvard Pilgrim Health Care and Tufts Health Plan, logged an adjusted net income of $68 million for the second quarter of 2026. 
    • “According to an Aug. 14 update shared with Becker’s, this profit was up from an adjusted net loss of $25 million during the same period in 2025.
    • “For the second quarter of 2026, operating income was $38 million. The operating loss in the second quarter of 2025 was $57 million.
    • “Point32Health had 1.9 million members during the second quarter of 2026, slightly down from 2 million members during the same time in 2025. Revenue was $2.3 billion for the second quarter of 2026, down about 4% year over year.”
  • and
    • “Health insurers denied between 12% and 18% of standard prior authorization requests across Medicare Advantage, Medicaid managed care and ACA marketplace plans in 2025, with wide variation among the largest payers, according to a KFF analysis published Aug. 13.
    • “CMS previously finalized a rule requiring certain insurers to publicly report prior auth metrics, including denial rates, processing times and appeal overturn rates. The first reports, covering 2025, were due March 31. The data is aggregated across all items and services, with no breakdown by service type, so there’s limited insight into what services are being approved or denied. Payers are also not required to report reasons for denials.
    • “The rankings below only cover standard prior auth requests and they don’t include data for prescription drugs (though CMS has proposed a rule to require that information to be public as well). Denial rates for urgent requests, which are included in KFF’s analysis, were slightly lower across all markets.
    • “Prior auth denials are rarely appealed, but when they are, a considerable share are overturned, including 67% for Medicare Advantage plans, 47% in Medicaid managed care and 43% in the ACA marketplace.”

Thursday report

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

Simplicity is a virtue.

From Washington, DC

  • Per a Department of Health and Human Service news release,
    • “The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today announced $102 million in New Access Points awards to significantly expand the reach of the Health Center Program. The awards represent the first major expansion of the Health Center Program since the first Trump Administration in 2019, supporting 158 new and existing health centers to establish 415 new sites and expand access to comprehensive primary care for nearly 1 million people nationwide.
    • “Strong primary care prevents disease and gives Americans greater control over their health,” said HHS Secretary Robert F. Kennedy, Jr. “This $102 million investment will bring high-quality care to nearly one million more Americans, expand prevention and nutrition services, and help communities tackle chronic disease at its roots. We are giving more Americans the tools to live healthier lives and Make America Healthy Again.”
    • “Learn more about the Health Center Program and find a health center near you.
    • “Visit the New Access Points webpage for more details on the program and a list of 2026 award recipients.”
  • Per a Government Accountability Office news release about a new report,
    • “National Crisis and Support Hotlines: Contact Volume Increased and Operations Remained Relatively Consistent in 2025
    • “GAO-26-109046. Published: Aug 13, 2026
    • “The federal government operates the following hotlines:
      • “Health and Human Services’ 988 Suicide & Crisis Lifeline provides 24/7 support to people in distress
      • “HHS’s National Maternal Mental Health Hotline provides emotional support to pregnant and postpartum women
      • “Veterans Affairs’ Veterans Crisis Line provides support to veterans, service members, and their families
    • In February 2025, the President issued an executive order aimed at reducing the size of the federal workforce. While HHS and VA reduced their staff, the hotlines’ operations and services remained mostly consistent, with an increase in chats, texts, and calls.
  • FEHBlog observation: While aware of the 988 line, he wants to call attention to the other two lines.

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

  • Federal News Network reports about, “FEHB and Medicare: Understanding how they work together in retirement.”
  • Fedweek explains “How FEDVIP Differs from FEHB in Retirement.”
  • Tammy Flanagan, writing in Govexec, advises “Before you take money out of your TSP, weigh these trade-offs.”
    • “A withdrawal can affect everything from your tax bill and Medicare premiums to how long your savings last and what your heirs receive.”
  • Federal News Network tells us,
    • “Following a year of sweeping staffing reductions, the Trump administration is laying the groundwork for agencies to ramp up recruitment efforts. The Office of Personnel Management has directed agencies to begin assembling “annual staffing plans” for fiscal 2027.”
  • Chief Data Officer Magazine informs us,
    • “The U.S. Office of Personnel Management (OPM) has directed federal agencies to make technology recruitment a key component of their fiscal year 2027 workforce plans. Guidance issued by OPM directs agencies to include dedicated hiring strategies for roles in artificial intelligence (AI), cybersecurity, software engineering, data science, digital services, and other technology fields in staffing plans due by Sept. 30.
    • “Agencies are also expected to assess how the adoption of modern technologies will affect workforce needs and align hiring accordingly.”
  • Federal News Network adds,
    • “The Merit Systems Protection Board is officially transitioning away some of its authority over adverse action appeal decisions. A new final rule from MSPB removes all references to the board’s prior jurisdiction over appeals due to firings or demotions during a reduction in force, probationary period or for a suitability-related reason. The adjustments at MSPB come after the Office of Personnel Management finalized rules to take over decisions in those three categories of workplace disputes. The change takes full effect in early September.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports.
    • “Novartis is recalling a single lot of valsartan, a blood pressure drug the company sells under the brand name Diovan, due to failed dissolution specifications. This means it is not dissolving correctly, which can impact the drug’s effectiveness. 
    • “The U.S. Food and Drug Administration (FDA) has categorized this as a Class II recall, meaning exposure to the drug may lead to “temporary or medically reversible adverse health consequences.” 
    • “Diovan is an angiotensin II receptor blocker used to treat hypertension and heart failure. It may also be prescribed to patients after a heart attack. This specific lot, AV5913C, includes packages of 90 160-mg tablets that expire in June 2027. The drugs were manufactured by Pantheon Manufacturing Services in Greenville, North Carolina, and distributed by Novartis Pharmaceutical Corp. in Hanover, New Jersey.”
  • Yahoo News relates,
    • “There’s an ongoing recall on a specific type of bladder medication distributed and prescribed nationwide, according to the U.S. Food and Drug Administration (FDA). This is due to an impurity issue.
    • “The medication being recalled is 25-milligram, 30-count bottles of mirabegron extended-release tablets manufactured by Zydus Lifesciences. The recalled bottles contain a lot code of “E408618,” an NDC of “70710-1159-3” and the expiration date “11/30/2026.” * * *
    • “Check your medication, and if you have the recalled product on hand, contact your pharmacy for a refund or replacement. Seek medical attention if you are experiencing any health concerns after consuming the affected pills.”
  • Reuters tells us,
    • “The U.S. FDA on Thursday approved Bristol Myers Squibb’s (BMY.N) oral combination treatment for patients ​with a rare form of blood cancer whose illness had relapsed or ‌not responded to other treatments, the health regulator said.
    • “The drug, iberdomide, with brand name Zenbexus, is given in combination with J&J’s (JNJ.N), opens new tab Darzalex and dexamethasone, a prescription medication used to reduce inflammation.” * * *
    • “The list price of Zenbexus is $29,500 ‌for ⁠a 28-day cycle, Bristol said. The company expects product availability within the coming weeks.”
  • The American Hospital Association News adds,
    • “The AHA Aug. 13 responded to a Food and Drug Administration request for input on the risks and benefits to health and safety associated with non-device software. Among its recommendations, the AHA supported the benefits of clinical decision support software and requested the FDA to permanently adopt flexibilities for CDS that generate only one clinical recommendation. The AHA also requested that the FDA clarify its general wellness guidance by providing additional resources on labeling and clarifying or removing references to allow non-device general wellness applications to make recommendations on escalation to a healthcare provider. Finally, the AHA encouraged the FDA to continue to update guidance, education and other materials to account for novel artificial intelligence applications, including generative AI. Input will support an agency report, as required under Section 3060 of the 21st Century Cures Act.”

No Surprises Act News

  • Following up on yesterday’s discussion of the U.S. Court of Appeals for the Fifth Circuit’s opinion about the calculation of qualifying payment amounts (“QPA”), the American Hospital Association tells us,
    • “A statement posted Aug. 13 on the Centers for Medicare & Medicaid Services website said that the agencies are reviewing the court’s opinion and judgement and anticipates issuing guidance shortly.” 
  • FEHBlog Observation: The Fifth Circuit is a victory for the majority of health care providers who accept the QPAs. No one can object to that outcome.
  • Beckers Hospital Review recounts “the never-ending No Surprises saga.”
    • “When President Trump signed the No Surprises Act into law in 2020, the straightforward premise was that patients should not be blindsided by massive emergency care bills from out-of-network physicians they never chose. On that front, the law has largely worked. 
    • “But the system Congress built to resolve payment disputes between insurers and providers has led to an increasingly expensive and bitter standoff that insurers say is driving up premiums, while physicians report waiting months to get paid. And employers, particularly the self-funded plans that cover the majority of commercially insured workers, say they’re the ones now stuck with a big chunk of the bill. In recent months, the courts, Congress and federal regulators have all been moving in different directions on exactly what to do about it.”

From the judicial front,

  • Beckers Hospital Review reports,
    • “The federal government has referred dozens of hospitals, pharmacy benefit managers and pharmacies to investigators over potentially fraudulent billing related to pediatric gender-affirming care.
    • “Vice President JD Vance referred hospitals and clinics identified in a new HHS report to the Justice Department, while HHS Secretary Robert F. Kennedy Jr. referred flagged organizations to HHS’ Office of Inspector General over “potentially anomalous billing patterns” identified through an analysis of insurance claims, according to an Aug. 13 news release.” * * *
    • “In the report, HHS shared its analysis of claims data spanning 2015 to 2025, identifying $47.6 million in claims for puberty-blocking drugs prescribed to patients 9 to 17 years old with endocrine disorder diagnoses, excluding precocious puberty. The patients also did not have a gender-related diagnosis documented. Of those claims, $42.6 million stemmed from an unspecified endocrine disorder diagnosis, the report said.” * * *
    • “The referrals mark the latest escalation in a federal crackdown on pediatric gender-affirming care that began shortly after President Donald Trump returned to office in January 2025. Some pediatric hospitals, most recently Hartford-based Connecticut Children’s Medical Center, have struck deals with the Justice Department and stopped providing gender-affirming care services.”
       
  • The Wall Street Journal relates,
    • “Luigi Mangione is expected to plead guilty Friday in a Manhattan federal court, where he is facing stalking charges in connection with the killing of UnitedHealthcare CEO Brian Thompson outside a Midtown hotel in 2024, people familiar with the matter said.
    • “The expected plea potentially resolves the federal case just a month before Mangione is scheduled to go to trial in New York state court on murder and other charges. But the people familiar with the matter cautioned that Mangione still could change his mind. And his defense team has abruptly shifted strategies previously.”

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “Arthritis in its many manifestations is among the most common chronic conditions, affecting some 53 million adult Americans, and its associated pain often impairs the ability to perform daily activities including work.
    • “The Healthy People 2030 initiative set a goal of reducing the prevalence of joint pain in the U.S. to about 52%.
    • “In this analysis of National Health Interview Survey data from 2023, moderate to severe joint pain was reported by 58% of those with arthritis, with no change from 2019 (57%) after adjusting for age distribution.”
  • and
    • “Estrogen-only menopausal hormone therapy was linked with reduced Alzheimer’s pathology in an autopsy study.
    • “Estrogen treatment was also tied to lower odds of dementia diagnosis.
    • “More than 20 years after the landmark Women’s Health Initiative trial, hormone replacement therapy remains controversial.”
  • Beckers Behavioral Health relates,
    • “A nationwide, evidence-based tobacco treatment program for cancer patients and survivors in the U.S. would save $12.32 billion in healthcare costs over 10 years, according to a study published July 14 in JCO Oncology Practice.
    • “Led by researchers from Houston-based University of Texas MD Anderson Cancer Center, the study projected 10-year survival trends and healthcare cost savings associated with a nationwide smoking cessation program targeted to 18 million U.S. cancer survivors.” * * *
    • “Read the full study here.” 
  • Healio adds,
    • “Exercise capacity, oxygen uptake and ventilation at peak exercise were significantly reduced in e-cigarette and conventional cigarette users vs. never smokers.
    • “Vascular function also followed this pattern.”
  • BioPharma Dive lets us know,
    • “Taiho Oncology and partner Cullinan Therapeutics said a targeted medicine they’re developing has succeeded in a Phase 3 trial in frontline lung cancer, with investigators halting the study at an early data check because of clearly positive results.
    • “Taiho and Cullinan have been testing that therapy, zipalertinib, alongside chemotherapy in the first-line setting in people whose lung tumors have a so-called exon 20 insertion in a gene called EGFR. They didn’t release detailed data, but on Wednesday said that the combination “demonstrated a statistically significant and clinically meaningful improvement” in progression-free survival, meeting a pre-planned threshold for unblinding the trial.
    • “The Food and Drug Administration is already reviewing zipalertinib as a second-line treatment and is expected to make a decision by Feb. 27. If approved, the drug will add to an already competitive market battle. Johnson & Johnson’s Rybrevant and AstraZeneca and Dizal’s Zegfrovy are both available, and another biotechnology company, ArriVent BioPharma, is expecting Phase 3 data later this year.”
  • and
    • “Boulevard Bio, a new startup co-founded by pioneering autoimmune disease researcher Georg Schett, officially launched Wednesday with $65 million in its coffers and three experimental drugs.
    • “One of those medicines is already in early testing. Called BLVD-101, that drug is a so-called bispecific antibody aimed at a pair of targets known to drive the progressive kidney condition IgA nephropathy.
    • “IgAN has become a popular target for drugmakers of late. In the last year, U.S. regulators have approved two drugs, Vera Therapeutics’ Trutakna and Otsuka Pharmaceutical’s Voyxact. A third from Vertex Pharmaceuticals could follow.”
  • Fierce Pharma notes,
    • “Roughly a year and a half after the approval of Vykat XR, a group of clinicians with deep ties to the Prader-Willi syndrome (PWS) community is flagging potential safety concerns about the rare disease med, acquired in Neurocrine’s $2.9 billion buyout of Soleno Therapeutics last spring.
    • “The package insert for Vykat XR (diazoxide choline)—a potassium channel activator that became the first drug approved to treat the sensation of insatiable hunger, or hyperphagia, in PWS in March 2025—already cites the risk of fluid overload, based on an increased incidence of edema seen during clinical trials. 
    • “Since becoming more widely available, additional reports of edema and related complications in patients taking Vykat XR have been posted to the FDA’s Adverse Event Monitoring System (AEMS), including seven reports of death and more than 100 other reports of serious adverse events, mostly tied to edema, respiratory and cardiac complications.
    • “The adverse event trend, which doesn’t establish that Vykat XR caused the events, was flagged in a statement (PDF) from PWS patient organizations the Foundation for Prader-Willi Research, the International Prader-Willi Syndrome Organization and Prader-Willi Syndrome USA. The issue was first reported by Stat News earlier on Wednesday.” 

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

  • The American Hospital Association News reports,
    • “A blog by Robyn Tessin, AHA director of policy, discusses the ways value-based care can meet patients’ needs, resulting in improved affordability and access to timely, coordinated care. “The promise of value-based care is a healthcare system that feels less like a collection of separate transactions and more like a connected journey centered on each patient,” Tessin writes. “No single payment model can solve every affordability challenge. But providers, policymakers, payers and patients can build on what is working — strengthening existing models such as [accountable care organizations], scaling innovations in care coordination and ensuring that the models’ financial incentives are meaningful for patients.” READ MORE 
  • Beckers Payer Issues adds,
    • “Mishawaka, Ind.-based Franciscan Alliance has partnered with Millennium Physician Group to expand value-based care and primary care access across Indiana.
    • “Fort Myers, Fla.-based Millennium is part of a national value-based care platform partially owned by Elevance Health.
    • “The partnership will combine Franciscan’s physician network with Millennium’s practice management, analytics and value-based care capabilities. Franciscan physicians will remain part of the health system’s physician network while gaining access to additional operational support, technology, care coordination resources and analytics.
    • “As Franciscan Alliance celebrates 150 years of serving Indiana, this partnership represents the next chapter in that mission,” Franciscan Alliance President and CEO Kevin Leahy said in an Aug. 12 news release. “By combining our trusted community presence with Millennium’s proven expertise in value-based care, we are strengthening our ability to expand access, enhance quality and deliver more affordable healthcare for generations to come.
    • “The organizations said the partnership is designed to reduce administrative burdens for physicians, improve clinical performance and strengthen chronic disease management and care coordination.”
  • Reuters relates,
    • “Novo Nordisk (NOVOb.CO) CEO Mike Doustdar said investors are underestimating the demand for differentiation among obesity drugs, ‌and that new treatment options like pills will keep it from becoming a winner-take-all battle with rival Eli Lilly.
    • “Novo was first to bring a highly effective GLP-1 weight-loss injection, Wegovy, to the U.S. market, but is under pressure to regain ground lost to Lilly’s (LLY.N) Zepbound in a business that ​analysts expect will be worth more than $100 billion a year by 2030.
    • “Doustdar, who took the helm at the Danish ​drugmaker a year ago, said that patients are just beginning to understand which GLP-1 drug is ⁠best suited to them, and he expects more segmentation as new medicines are approved. More than 100 million U.S. adults ​are classified as obese.
    • “Right now the investor community has thought this is supposed to be a zero-sum game between two players – ​there’s a loser and a winner,” Doustdar said in an interview with Reuters on Wednesday.
    • “As you foresee the future of GLP-1s and obesity and weight-loss drugs, it will not be Coke versus Pepsi. It will be Coke and Pepsi and Fanta and Dr Pepper and Red Bull. People are ​thirsty, and they can make their choices,” he said.”
  • Beckers ASC Review tells us,
    • “For much of the past decade, the story of physicians’ practice has moved decidedly away from independence. 
    • “Hospital and corporate employment of physicians climbed from 62% to 78% between 2019 and 2023, and private practice fell from 60% of physicians in 2012 to just 42% in 2024, according to data from the Government Accountability Office.
    • “But 2026 is producing early signs that the pendulum may be swinging back, not toward the traditional solo practitioner model, but toward a new one built around management services organizations, physician practice networks and other arrangements designed to help physicians reclaim ownership and autonomy without giving up the scale and capital that made employment attractive in the first place.”
  • Healthcare Dive informs us,
    • “Nonprofit hospitals and health systems rated by credit ratings agency Fitch raised their operating margins and extended their financial recovery last year, according to a Fitch Ratings report based on audited fiscal 2025 data.
    • “The median operating margin among 222 nonprofit providers rose to 1.5%, compared to 1.1% in 2024, according to the report, and gains were increasingly concentrated among more financially stable providers. 
    • “Still, Fitch warned that 2025 could prove to be an “operational peak” before Medicaid funding reductions and other policy changes begin to pressure hospital revenue more significantly in 2027. Financially unstable and Medicaid-dependent providers have less financial cushion to absorb the coming strain, according to the credit ratings agency.”
  • Fierce Healthcare points out,
    • “Aetna is seeing its value-based care efforts pay off in both preventive care metrics and cost savings, according to a new analysis from the company.
    • “The insurer compared (PDF) outcomes across 20 different measures for individuals in its Medicare Advantage plans between value-based models and fee-for-service, and found that the value-based arrangements supported better results across 17 of the included measures.
    • “For example, value-based care models far outpaced fee-for-service in managing blood sugar and high blood pressure. Under value-based care, 43% more members controlled their HbA1C and 34% had controlled blood pressure, according to the analysis.
    • “In addition, 20% more patients were screened for colorectal cancer under value-based care and there were 7% fewer hospitalizations. These providers also generated $315 million in savings during plan year 2023, 2.6% higher than fee-for-service providers.”
  • and
    • “Cedar, a patient financial platform for healthcare providers, launched an agentic artificial intelligence platform Thursday aimed at patient medical billing.
    • “Kora Platform is a suite of purpose-built AI agents that integrates with healthcare organizations’ existing electronic health records (EHRs), telephony and call center systems. Some of the capabilities included within the suite include autonomous inbound voice, autonomous outbound voice, two-way text and advanced reporting.
    • “We really want Kora Platform to be this agentic advocate that’s sitting in the pocket of every patient,” Cedar Chief Strategy Officer Dugan Winkie told Fierce Healthcare.”
  • The American Medical Association lets us know about “four AI prompts to help prepare for your doctor’s appointment.”
    • “Here are some top expert tips on how to use AI chatbots in a way that makes the most of your time in the exam room with your physician.”

Monday report

David Ermer–Uncategorized–

Simplicity is a virture.

From Washington, DC,

  • The American Hospital Association News reports
    • “The Senate’s budget resolution to set up a third reconciliation bill was released Aug. 7 by Sen. Ron Johnson, R-Wis., chairman of the Senate Budget Committee. It instructs 11 Senate committees to provide up to $150 billion in funding by Sept. 11. No healthcare committees received instructions. The House passed its budget resolution July 21. That version instructs the House committees on Administration, Agriculture, Armed Services and Intelligence to draft legislation that provides up to $95 billion in funding by Sept. 11.
    • “Legislators continue to focus their efforts on a reconciliation bill that would narrowly provide additional funding for defense, farm aid and election-related provisions. The House and Senate must pass an identical budget resolution before moving forward with a reconciliation bill. Additional legislative activity is expected in September when Congress returns to session.” 
  • The Wall Street Journal relates,
    • “President Trump signed a new executive order Monday calling for most children to receive fewer vaccines and made some of his most extensive comments yet linking childhood shots and autism—a connection that scientists have said is unfounded.
    • “The document Trump signed Monday is similar to a previous executive order to decrease the number of vaccines children receive. It also urges parents to spread out vaccines in more visits to pediatricians’ offices and encourages states to mandate fewer vaccines for school attendance. It calls for the measles, mumps and rubella vaccination to be given in separate shots rather than the combination shot commonly given in the U.S.
    • “The new executive order goes further than the prior effort by grouping vaccines into three buckets: those recommended for all children, those recommended only for high-risk children and those that are subject to “shared-decision making,” in which parents and doctors discuss risks and benefits for each child. Included in the final category are vaccines for Covid-19, the flu, hepatitis B and more.
    • “The order doesn’t explicitly link vaccines to autism, but the president did so in his remarks Monday at an Oval Office event.” * * *
    • “The order calls on Kennedy and a newly revived vaccine task force to, in the next 90 days, come up with new recommendations for the timing and sequencing of childhood vaccines and find alternatives to a common vaccine ingredient, aluminum. A study of more than one million children in Denmark last year found no link between aluminum in vaccines and childhood chronic diseases, but Kennedy denounced the study. Scientists have said children are exposed to more aluminum from daily life than they receive in vaccines.”
  • and
    • “The Trump administration took a partial step Monday toward Health Secretary Robert F. Kennedy Jr. promised food-system overhaul.
    • “Here’s what to know:
      • “Kennedy’s health department is asking food companies for more information about the substances they are putting into the U.S. food supply.” * * *
      • “The new proposed rule falls short of what some food-safety advocates have hoped for. Acting Food and Drug Administration Commissioner Kyle Diamantas said the notifications for new substances are mandatory, but it was unclear how the government will enforce the requirement. Food suppliers can still put new ingredients on the market before they notify regulators, Diamantas said.” * * *
      • “Health officials said stronger regulation—such as blocking companies from going to market before the FDA signs off on the safety of their ingredients—would require congressional action.” * * *
      • “Kennedy blames ultraprocessed food for many of America’s health woes, and in February promised to release a definition of ultraprocessed food by April. Such a move would allow the FDA to craft labeling rules based on the definition, he said. 
      • “The health department was widely expected to release the definition on Monday, but health officials said the draft was still being reviewed by other agencies.” 
  • Govexec tells us,
    • “The largely self-funded Postal Service is asking for “modest” annual funding from Congress, at least in the short term, to help the agency pay its bills. 
    • “USPS told lawmakers that it would run out of cash in early 2027, if it kept meeting all of its financial obligations. But the agency now expects to avoid a cash crisis for another few years by suspending its contributions to one of its employee retirement plans. 
    • “Agency leaders warn these extraordinary measures are just buying USPS more time to deal with what they consider a broken business model. 
    • “Postmaster General David Steiner said last Friday that USPS will seek a “relatively modest appropriation” from Congress, adding that those funds would “create a large return for the American economy.” 

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

  • An OPM news release offers a transcript of (OPM Director Scott Kupor[‘s conversation during] Greg Kelly Reports on Newsmax to discuss the Trump Administration’s efforts to restore merit-based hiring and strengthen accountability across the federal workforce.

From the Food and Drug Administration front,

  • The New York Times reports,
    • “Taylor Farms, which has been linked to a large outbreak of cyclosporiasis associated with iceberg lettuce in the United States, said on Sunday that it was voluntarily recalling several of its products made with fresh jalapeños that have been tied to a multistate salmonella outbreak.
    • “The recalled products include spicy guacamole, mango pico de gallo, taco dip and more than a dozen other Taylor Farms branded and unbranded products, the company said in a statement on its website. They were distributed across 26 states to major retailers — including Whole Foods, Trader Joe’s, Hannaford and Kroger’s — and have a “Best If Used By” date up to and including Aug. 16, 2026.”
  • STAT News relates,
    • “The Food and Drug Administration has rejected a radiopharmaceutical therapy because of manufacturing issues, halting what would have been a competitor for Novartis. 
    • “The drug, ITM-11, had been developed by ITM Isotope Technologies Munich SE, a long-standing player in the field. Radiopharmaceuticals are an emerging type of treatment designed to shoot radioactive isotopes directly at tumor cells.” * * *
    • “ITM has more than a dozen drugs lined up behind ITM-11, for glioblastomas, renal cell carcinoma, as well as prostate and ovarian cancers.
    • “The company plans to resubmit the ITM-11 application. “Our confidence in ITM-11’s therapeutic potential has not wavered, and we are committed to working closely with the FDA and our partners to address the items outlined in the CRL,” CEO Andrew Cavey said in a statement.” 
  • and
    • “Sanofi is experiencing shortages of two medicines used to treat Pompe disease, and the problem emerged shortly after the Food and Drug Administration warned the company over manufacturing issues at the Irish facility where the drugs are made.
    • “In recent days, the drugmaker has alerted patient groups and physicians in both the U.S. and Europe that supplies of Myozyme, an older standard of care, and Nexviazyme, a newer treatment, are dwindling due to what has been described as a bottleneck in the final manufacturing phase, as well as quality control issues at its Waterford plant.” * * *
    • “For now, it is not clear when normal supplies will return because Sanofi has indicated it could take months before production has sufficiently resumed and stabilized. But the shortage will continue to reverberate after that occurs, because it will likely take time for normal inventories to be rebuilt, according to a statement on the IPA website.”

From the judicial front,

  • Beckers Hospital Review reports,
    • “A federal judge has dismissed an antitrust lawsuit brought by compounding pharmacy Strive Specialties against Eli Lilly and Novo Nordisk.
    • “The ruling, filed Aug. 3 in the U.S. District Court for the Western District of Texas, found the company failed to plausibly allege a legally cognizable product market or a cognizable antitrust injury.
    • “Strive filed the lawsuit in January, accusing the drugmakers of using exclusive-dealing agreements with telehealth providers and public statements questioning compounded drugs’ safety to unlawfully restrict competition and limit patient access to compounded GLP-1 medications.
    • “The court found Strive’s compounded products cannot be considered reasonably interchangeable with Lilly and Novo Nordisk’s branded GLP-1 medications, because compounded versions are legally available only when a prescriber determines a branded drug is medically unsuitable for a specific patient. That determination is driven by necessity rather than ordinary consumer preference, the court ruled, undercutting Strive’s proposed cash-pay submarket and its broader GLP-1 market theory alike. Without a viable relevant market, the court found Strive’s Sherman Act and Clayton Act claims, including its challenge to Lilly and Novo Nordisk’s exclusivity arrangements with telehealth platforms, also failed.”
  • Health Exec relates,
    • “A newspaper reporter just got an exclusive peek inside a law-enforcement operation that most Americans—including the well-informed among us—know next to nothing about. He took notes and is sharing what he can. 
    • “The operation is the National Training Operations Center—NTOC, called “Noc” for short—of HHS’s Office of Inspector General (HHS-OIG). It’s largely hidden in plain sight for obvious reasons, but it’s a prime mover in the Trump administration’s ongoing crackdown on healthcare fraud. 
    • “The reporter is Chadwick Moore of the New York Post.” * * *
    • “Here are six telling observations the newshawk offers in his article, posted by the Post on Aug. 6. 
      • “More than a few agents are healthcare professionals who feel passionate about stopping healthcare fraud.” * * *
      • “The stealthy suburban facility features highly realistic mockups of medical offices—physical as well as virtual.” * * *
      • “Often the HHS-OIG anti-fraud team is not catching someone red-handed—they’re proving a negative.” * * *
      •  “A Faraday box is essential equipment for the team.” * * *
      • “HHS-OIG is exempt from HIPAA. * * *
      • “In cities where fraud is rampant, real patients are often part of the problem.” * * * 

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “Department of Health and Human Services Secretary Robert F. Kennedy Jr. Aug. 7 declared a public health emergency for Washington state to address the impacts of ongoing wildfires. This follows an emergency declaration approved by President Trump Aug. 4. Because of both a presidential declaration and a PHE, the loosening of certain regulatory requirements for Medicare, Medicaid and the Children’s Health Insurance Program is permitted under the Section 1135 waiver process. 
    • “The Administration for Strategic Preparedness and Response said it has sent regional staff to support Washington state officials and partners with the public health and medical response. The Washington State Hospital Association has also provided a series of resources to assist with response efforts.”
  • The American Medical Association News lets us know “what doctors want patients to know about tickborne illnesses.”
    • “Tickborne illnesses can start with a single bite. Know the signs, prevention steps and when to call a doctor to protect your health.”
  • ALS News Today relates,
    • “Traumatic brain injuries are often linked to a higher short-term mortality risk in patients with ALS [Lou Gehrig’s Disease].”
    • “The connection could suggest reverse causation, where early, undiagnosed ALS leads to falls and resulting head injuries.
    • “Further research is required to evaluate diagnostic timing and clarify the relationship between traumatic brain injury and ALS.”
  • Health Day tells us,
    • “Yoga may help relieve symptoms of irritable bowel syndrome 
    • “People with irritable bowel syndrome who practice yoga experience fewer digestive symptoms, as well as reduced anxiety and depression
    • “Researchers think yoga’s combination of movement, breathing and mindfulness activates the body’s ‘rest and digest’ response.”
  • MedPage Today points out,
    • “In 2024, the national incidence rate of type I diabetes was 24.0 per 100,000 persons under age 20, but state-level rates ranged from 17.0 to 27.8.
    • :The ratio of board-certified pediatric endocrinologists to patients with type 1 diabetes also varied widely.
    • :Three states had fewer than five pediatric endocrinologists per 1,000 patients under age 18; in contrast, Washington, D.C. had 46.4.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Targeted protein degradation is a therapeutic strategy that leverages the ubiquitin–proteasome system to eliminate disease-associated proteins—including those that have traditionally been considered undruggable.
    • “Protein degraders remove unwanted proteins from inside a cell by disposing of them using the cell’s built-in recycling system. Specifically, a molecular glue degrader binds an E3 ligase and redirects it to tag a disease-related protein for disposal.
    • “Now, investigators at Dana-Farber Cancer Institute have developed a platform for systematically discovering molecular glues that could become protein degradation drug candidates. The platform could help drug developers expand the range of disease-related proteins that can be therapeutically targeted for elimination via protein degradation. The platform also enabled their discovery of the first molecular glue degrader that is metabolically activated, suggesting that molecular glues could be more context dependent and potentially tunable than previously thought.
    • “The study was published in Nature in the paper, “DCAF11-dependent molecular glue degrader activated by glutathionylation.”
    • “This novel platform is an exciting scalable approach to the discovery of molecular glues that could help drive the significant expansion of molecular glue applications for the treatment of cancer and other diseases,” says Eric Fischer, PhD, professor of Biological Chemistry and Molecular Pharmacology at Harvard Medical School.”
  • STAT News notes,
    • “Tenax Therapeutics on Monday reported negative results from a late-stage clinical trial evaluating an experimental treatment for a type of heart failure associated with high blood pressure in the lungs.” * * *
    • “Despite the failed study, Tenax does not appear ready to give up on oral levosimendan. The company believes the drug may have a benefit for PH-HFpEF patients with more severe disease, based on pre-specified and post-hoc analyses of the LEVEL study. 
    • “Having reviewed the available trial results, I am encouraged we have a clear path forward,” said Tenax Chief Medical Officer Stuart Rich, in a statement.
    • “The company said it will meet with the Food and Drug Administration to discuss the LEVEL study results and potentially make changes to a second Phase 3 study already underway.”
  •  and
    • “Sionna Therapeutics said Monday that its experimental pill for cystic fibrosis did not show any benefit when added onto Vertex Pharmaceuticals’ Trikafta in a Phase 2 trial. 
    • “The company will no longer try to advance the drug, called SION-719, as an add-on therapy for CF patients. And it hinted at potential layoffs, saying it will “take actions to preserve capital while evaluating next steps.”

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

  • Fierce Pharma reports,
    • “Everything is bigger in Texas. And so it is with Bristol Myers Squibb’s $2.3 billion investment in a manufacturing campus in Houston, which comes in at more than twice the price the company estimated in a government application earlier this year.
    • “In May, the New Jersey pharma filed documents with the state of Texas to build a $1 billion, 600,000-square-foot complex, with an option to expand, in the Generation Park Management District in northeast Houston. It was one of several U.S. sites BMS was considering, the company said at the time.
    • “On Monday, BMS made it official in a statement saying it intends to employ nearly 500 at the facility, which will be built to “grow in scale, capability and workforce for decades to come.” It will support drug product and finished manufacturing from late development through launch, the company added, with plans to finish construction in 2030.” 
  • BioPharma Dive adds,
    • “Jazz Pharmaceuticals has agreed to buy a San Diego-based biotechnology company developing treatments for genetic epilepsies, through a deal that could be worth just over $1.3 billion.
    • “Terms hold that privately held Actio Biosciences will receive $820 million up front and be eligible for $500 million in additional payments if its research programs hit certain regulatory and sales milestones. The company’s most advanced drug is being tested against a rare form of epilepsy caused by mutations in a gene known as KCNT1.
    • “The companies expect to close their deal sometime in the final three months of the year. Concurrent with the closing, Actio will spin out a new private entity funded by existing investors and headlined by one of its other programs, an ion channel inhibitor in early-stage testing for a form of “Charcot-Marie-Tooth,” an uncommon neurological disease. Jazz said it will hold a minority stake in the spinout — an investment that, by focusing on rare diseases, “represents a strong strategic fit” for its long-term strategy.”
  • and
    • “The race to build pharma’s most powerful supercomputer gained a new entrant last month, when Bristol Myers Squibb said a newly expanded partnership with Nvidia would give it “the most powerful and energy-efficient single-owned Nvidia infrastructure in life sciences.”
    • “Bristol Myers is the latest large pharmaceutical company to stake an AI-computing superlative claim along those lines. Eli Lilly said in October it would work with Nvidia to build “the most powerful supercomputer owned and operated by a pharmaceutical company.” In March, Roche said an expanded Nvidia collaboration gave it “the pharmaceutical industry’s largest announced hybrid-cloud AI factory,” with more than 3,500 GPUs, or graphics processing units.”
  • Beckers Payer Issues identifies the ten insurers exiting the Affordable Care Act market next year (updated as of today).
  • Beckers Hospital Review points out the 17 health systems with credit rating upgrades and tells us,
    • “A July 21 Center for Healthcare Quality and Payment Reform analysis found 700 rural hospitals are at risk of closing across the U.S. In almost every state, at least some rural hospitals are at risk of closing, with the exception of four. 
    • “The report did not classify a single rural hospital in Delaware, Maryland, New Jersey or Utah as “at risk of closing” or “at immediate risk.”
    • “Becker’s connected with hospital association and state agency leaders in each of those states to discuss what they credit for this stability. Their responses point to geography, a mix of specific state payment policy and long-standing regional partnerships.” 
  • MedTech Dive informs us,
    • “IRhythm said Thursday it has struck a deal to buy VitalConnect for $287.5 million to add mobile cardiac telemetry capabilities. 
    • “VitalConnect sells a wearable device, VitalPatch, that monitors for 21 cardiac arrhythmias and several vital signs. The device lasts seven days, after which users can apply a new patch.
    • “IRhythm sells its own cardiac monitor and is working to secure clearance of a second device, but it has identified VitalPatch as a product that can unlock another part of the market.”  
  • Beckers Clinical Leadership notes,
    • “This year, CMS has implemented eight changes to the HCAHPS survey and scoring.
    • “The changes are part of CMS’ HCAHPS 2.0 launch, which began in 2025. Last year, CMS began allowing patients to fill out the HCAHPS survey online; sunset two survey administration options; added three submeasures for care coordination, restfulness and information about symptoms; extended the data-collection period from 42 to 49 days; ended regulation that prohibits patients’ loved ones from filling out the survey on their behalf; limited the number of supplemental items; and required hospitals to collect information about the language patients speak.
    • “The first results of the HCAHPS 2.0 rollout are due to be published any day, Rick Evans, strategic advisor at New York City-based NewYork-Presbyterian, said in an Aug. 6 column.”
  • Per Fierce Healthcare,
    • “Women’s health companies drew a record $1.55 billion in disclosed equity investment in 2025, up 41% from $1.1 billion in 2024, according to a recent report from W Group.
    • “The report, the organization’s first global women’s health investment report, was built on proprietary tracking of more than 500 funding stories and around 164 equity rounds, and it reveals a sector at its largest-ever scale, with capital reaching more companies, categories and countries than at any point on record, according to W Group, a data-first intelligence platform.
    • “Eighty-five companies raised equity in 2025, the highest single-year count ever recorded, and 10 rounds reached $50 million or more, double the number in 2024.” * * *
    • But the report’s central finding is not the headline number. It is that the money has stopped concentrating at the top. In 2024, the three largest rounds accounted for 41% of all disclosed capital; in 2025 that share fell to 32%, as funding to companies outside the top three grew 56% year over year. 
  • and
    • “Doximity is boosting artificial intelligence spending, viewing it as a significant catalyst for growth, and CEO Jeff Tangney is bullish that hospital adoption of enterprise AI platforms will ramp up.
    • :Doximity is a digital platform for U.S. medical professionals that offers workflow tools such as a telehealth solution, a clinician-to-patient dialer tool and digital faxing capabilities. Its paying customers include pharmaceutical manufacturers, health systems and medical recruiting firms.
    • “The company aims to become a leading AI platform for doctors with plans to scale its clinical AI suite, including its ambient notetaking tool Scribe and clinical AI assistant and medical search engine Ask. A year ago, Doximity acquired clinical AI company Pathway and then integrated Pathway’s datasets and its AI into its free Doximity GPT product to offer DoxGPT (now Ask).
    • “Healthcare AI will increasingly be purchased by hospitals rather than individual physicians, with companies winning on accuracy and trust of the AI, Doximity executives assert.”

Notable Deaths

  • The New York Times reports
    • “Maura Gillison once told an interviewer that she had wanted to be a doctor and a scientist since childhood. She trained in ballet, but as she grew, reaching a height of 6-foot-2, dance became an unlikely career path because she felt that it would draw too much attention to her height.
    • “Instead, she forged a trailblazing career as a medical oncologist and molecular epidemiologist, studying head and neck cancers. In the early 2000s, she was credited as the first researcher to show definitively that the human papillomavirus, or HPV — the most common sexually transmitted infection — caused the so-called oropharyngeal cancers of the throat, tonsils and base of the tongue.
    • “No head and neck medical oncologist has had a bigger impact on patients than Maura Gillison,” Dr. John V. Heymach, the chair of thoracic/head and neck oncology at MD Anderson Cancer Center in Houston, where Dr. Gillison conducted research beginning in 2017, said in an interview.
    • “Dr. Gillison died on June 21 at her childhood family home in Willoughby, Ohio, northeast of Cleveland. She was 61. The cause was a rare cancer of the small intestine, her husband Dr. David E. Symer, an oncologist, said.”
  • Beckers ASC relates,
    • “American College of Cardiology Past President Robert Frye, MD, has died at age 94 after a career spanning more than 70 years in medicine, the ACC announced Aug. 7. 
    • “Dr. Frye served as ACC president from 1991 to 1992 and spent more than 60 years practicing and teaching cardiology at Mayo Clinic in Rochester, Minn.
    • “Dr. Frye earned his medical degree from Vanderbilt University School of Medicine in 1956 and trained in residency at Johns Hopkins Hospital in Baltimore. He went on to become the first physician research fellow and clinical associate at the National Institutes of Health, recruited by Eugene Braunwald, MD, MACC.” * * *
    • Valentin Fuster, MD, PhD, MACC, who worked alongside Dr. Frye as the first Braunwald fellow at the NIH, said Dr. Frye “helped lay the foundation for a generation of clinical discovery that transformed” cardiovascular medicine.
  • RIP. The FEHBlog also encourages his readers to listen to Russ Roberts’ Econtalk discussion with former U.S. Senator Ben Sasse.
    • From the transcript
      • Ben Sasse: “So, to be pushing seven months when you had 90 days to live is pretty great. And, that’s because of the really wonderful experience of being on daraxonrasib, this new miracle drug at UCSF [UCSF] and a few other places, that’s a RAS [renin-angiotensin system] inhibitor. If you’re 80-something, pancreatic cancer might be environmental. If you’re 50 something, like I am, it’s almost always a genetic mutation. 89% of people have a RAS mutation. So, this new drug–there hadn’t been good news in pancreatic cancer in 40 years–this new drug essentially tries to inhibit the RAS mutation’s ability to toggle the on-off switches the wrong way.
      • “The great news is my tumors are down over 80% right now. The bad news is, it’s probably not going to be a cure for me because I presented so far along and so metastasized, but this drug is going to be super-interesting over the next two to ten years.
      • “My two rough byproducts right now of a really aggressive dose of chemo are a real hard time growing skin and hair, so my root follicles on my head are all kind of tingly and falling out and bleeding all the time. So, my scalp is real a bloody mess, but I have an amazing dermatological oncology team at MD Anderson>

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Cybersecurity, Uncategorized–

“We are in the Singularity.” Elon Musk

From the Project Glasswing front,

  • The Wall Street Journal reports,
    • OpenAI is pausing some activities involving an upcoming artificial-intelligence model, Astra, after internal evaluations led the company to conclude it “cannot rule out critical cyber capabilities,” the company said in a blog post on Friday [August 7, 2026]. 
    • The announcement of the slowdown, which represents one of the first times an AI developer has publicly held back model development due to security concerns, follows a series of loss-of-control incidents that have raised alarm among cyber defense professionals and AI-safety researchers. 
  • and
    • “Meta Platforms META  said that one of its artificial-intelligence models went rogue during cybersecurity testing, slipped onto the internet and hacked a third-party service, the latest in a drumbeat of disclosures that suggest such incidents are becoming widespread.
    • “The Instagram and Facebook owner said that one of its AI models was able to access the internet because of a “misconfiguration” in a hacking test conducted by a third-party AI testing company. 
    • “The same benchmark test, which aims to explore a model’s hacking capabilities, was behind some of several earlier autonomous AI hacking incidents involving Anthropic and OpenAI, according to a person familiar with the matter. * * *
    • “Irregular, the company that conducted tests for the three companies, said the incidents didn’t involve a sophisticated cyber action and said it had “no current open issues” related to its test environment. The San Francisco-based company said it is working on a white paper on best practices for containing AI models when running tests—dubbed evals—of their cybersecurity capabilities.
    • “The new case [reported August 6, 2026] is the latest proof that AI loss-of-control scenarios, once confined to science fiction and AI-safety experiments, are now a real-world issue.”
  • Cybersecurity Dive relates,
    • “An alliance of more than 100 tech companies and other organizations is proposing a safety reporting system for AI agents that the group says will help prevent rogue models from wreaking havoc on society.
    • “The Shared AI Findings Exchange (SAFE), crafted by a working group of the Open Secure AI Alliance, would establish mechanisms for collecting information about AI-related security incidents, sharing that information with affected organizations, identifying commonalities across incidents and publishing recommendations based on those lessons.”
  • Tech Times adds,
    • “ByteDance is pre-training an artificial intelligence model with up to 10 trillion total parameters — a scale that would make it the largest AI model ever built by a Chinese company and place it within striking distance of Anthropic’s Mythos system, the Financial Times reported Friday, citing people familiar with the matter. The headline figure is real and remarkable. What it does not tell you — what ByteDance has not disclosed and no outlet has yet asked — is how many of those parameters actually activate during any given query. At a scale like this, that distinction changes everything.”
  • FEHBlog observation; Ruh-roh.
  • Cyberscoop notes,
    • “As AI-generated code continues to be injected into all corners of the internet, concerns have risen about an expanding attack surface for malicious hackers to exploit.
    • “Some have argued that the enhanced cybersecurity capabilities of large language models could serve as a check, finding and fixing vulnerabilities nearly as fast as they’re created.
    • “But new research that tested the patching capabilities of two popular commercial models, OpenAI’s ChatGPT 5.5 and Anthropic’s Claude Opus 4.8, found that generative AI is more likely to create an exploitable patch or introduce entirely new bugs than close off a vulnerability.
    • “Researchers at 1Password tested the models ability to patch six “high-impact, high-complexity” CVEs, including the “Copy Fail” vulnerability, a kernel flaw that can give an attacker root access to Linux cloud environments. The overall success rate (or fully patching the vulnerability without introducing new problems), was less than a coin flip at 47%.
    • “Our research findings show that, in aggregate across a variety of scenarios, both Claude and ChatGPT had a low rate of successful patch generation, which we define as full remediation of all known exploit paths with no erroneous changes to application behavior,” wrote John Hoodlet, Axel Mierczuk and Spencer Michaels.

From the cybersecurity policy and law enforcement front,

  • Roll Call reports,
    • “The Senate easily passed a bipartisan continuing resolution early Saturday morning [August 8, 2026] likely easing the traditional September rush to head off a partial government shutdown in October.
    • “On a lopsided vote of 90-6, the Senate passed a measure that would extend current funding through Dec. 11, giving lawmakers about 10 extra weeks to complete full-year appropriations bills for fiscal 2027.
    • “But the bill still requires a vote in the House, which won’t be back in session until the first week of September. The House had passed a more bare-bones funding extension last month without many of the “anomalies,” or deviations in current spending, requested by the Trump administration.”
  • Federal News Network adds,
    • “The Senate’s bill to keep the government funded past the midterm elections would extend critical cybersecurity authorities and allow the Technology Modernization Fund to continue investing in agency tech projects. * * *
    • The Senate CR, unlike the House bill, would extend two cybersecurity authorities for the duration of the stopgap: the Cybersecurity Information Sharing Act of 2015 and the Federal Cybersecurity Enhancement Act of 2015. Both laws are set to expire after Sept. 30.
    • CISA 2015 provides privacy and liability protections to encourage companies to share data about cyber vulnerabilities and threats with government and each other. Cybersecurity leaders say those protections provide a critical underpinning to facilitate collaboration across government and industry. * * *
    • “Meanwhile, the Federal Cybersecurity Enhancement Act authorizes the Department of Homeland Security to deploy intrusion detection tools, like the long-running “EINSTEIN” service, across federal agencies.”
  • Cybersecurity Dive relates,
    • “National Cyber Director Sean Cairncross on Tuesday [August 4, 2026] said the Trump administration is working to strike a balance between responsible, secure development practices, while promoting growth and allowing the private sector to innovate. 
    • Cairncross, the opening keynote at the Black Hat USA 2026 cybersecurity conference, said the White House understands the growing safety concerns about AI, but recognizes the need to work collaboratively with the private sector. 
    • He warned that due to the current pace of innovation, an overly prescriptive regulatory regime could be obsolete within 48 hours of being implemented.  
    • “So what needs to be built is a flexible, adaptable structure that enables information sharing between industry and government,” Cairncross said. “So we can guarantee that this technology benefits everyone that it’s going to benefit but is used responsibly and securely.”
  • and
    • “Policymakers and business executives need to focus on basic cybersecurity resilience instead of getting distracted by flashy claims about AI-fueled hacking nightmares, a group of senior U.S. and allied government officials said on Wednesday.
    • “The immediate challenge is not runaway AI,” Jonathon Ellison, director for national resilience at the UK’s National Cyber Security Centre, said during a panel at the Black Hat 2026 cybersecurity conference here. “The immediate challenge is being resilient enough for the faster-paced environment that we are entering into, given the legacy issues that we are carrying.”
    • “Michael Duffy, the acting U.S. federal chief information security officer, said organizations needed to shift from a prevention-focused mindset to one that prioritizes continuity of services.
    • “Things will go down,” he said, and organizations need to prioritize their most important systems so they can continue delivering on their mission.
    • “The cybersecurity community, he added, needs “a new risk calculus for what it means to operate in a contested environment.”
  • The Wall Street Journal tells us,
    • “An outbreak of digital attacks on U.S. water plants is stoking fears across party lines that budget cuts at the federal government’s primary cybersecurity agency could leave the nation ill-equipped to thwart global hackers.
    • “We need a skilled cyber workforce at CISA,” Rep. Andrew Garbarino, a New York Republican, said about the Cybersecurity and Infrastructure Security Agency. Garbarino, who chairs the House homeland security committee, said Congress and the White House need to work together to ensure the agency has the staff and resources to protect critical infrastructure.” * * *
    • “In April, CISA’s annual budget was cut by $300 million, to $2.6 billion from $2.9 billion, reversing an annual growth rate of roughly 9% since the agency was launched in 2018. The shortfall has both Republican and Democratic lawmakers seeking ways to recharge the agency—for a start, by confirming a permanent director, a role vacant since January 2025. 
    • “Rep. Bennie Thompson (D., Miss.), ranking member on the Homeland Security committee, said he plans to propose legislation aimed at guiding the process of restaffing CISA. Thompson didn’t provide a timeline, saying he will also work with appropriations to restore the agency’s funding. Staff and budget cuts, he said, have “damaged our national security and set critical capabilities back years as the security environment is shifting under our feet.”
    • “An agency spokesperson said CISA is “constantly assessing our operational needs as the threat landscape evolves” and that Homeland Security recently approved new hiring in several mission critical positions.”
  • Cyberscoop informs us,
    • “A Canadian man pleaded guilty to playing a central role in one of the most far-reaching cyberattacks of 2024 — the widespread compromise of more than 165 Snowflake customer environments, resulting in massive data theft for extortion, the Justice Department said Wednesday [August 5, 2026]. 
    • Connor Moucka earned $495,000 by extorting his victims, offering stolen data for sale online, and in one case re-extorted a victim with stolen data of a government official and members of a then-former government official’s immediate family, authorities said.
    • Moucka and his alleged co-conspirators John Binns and Cameron Wagenius stole billions of sensitive records and received more than $2.5 million in extortion payments combined, according to prosecutors. Victims of the attack spree included AT&T, Ticketmaster, Advance Auto Parts and Santander.
  • and
    • “A longtime cybercriminal was sentenced to 16 years in prison for creating and running Ransom Cartel, a ransomware strain linked to attacks on at least 18 companies between 2021 and 2023, the Justice Department said Wednesday [August 5, 2026]. 
    • “Maksim Silnikau, a Belarusian national, actively participated in Russian-speaking cybercrime forums since at least 2005, and was a member of the cybercrime site Direct Connection from 2011 to 2016, officials said. The 40-year-old created Ransom Cartel and began recruiting participants from cybercrime forums in 2021. 
    • “Silnikau and his co-conspirators attempted to extort at least $5.2 million from victims during the multi-year scheme. 
    • “Victims included a group of law firms, medium-sized businesses, a small medical technology startup, educational institutions and large multinational corporations based in California, New York, Nebraska and elsewhere. Some of the victims’ operations were disrupted for several months, officials said.
  • HIPAA Journal points out,
    • “Over the past 18 months, many healthcare providers have settled class action lawsuits over their use of website tracking and analytics tools. The list continues to grow with a further five settlements recently announced [and discussed in the article]; however, class action lawsuits stemming from the use of tracking and analytics tools do not always result in settlements.
    • “A proposed class action lawsuit against CRH Healthcare, doing business as Peachtree Immediate Care in Georgia, that alleged violations of the federal Electronic Communications Privacy Act and asserted claims for negligence/negligence per se, breach of implied contract, breach of express contract, breach of fiduciary duty, and unjust enrichment, has been dismissed with prejudice.
    • “The judge ruled that the complaint was speculative, as the plaintiff failed to explain what damages had been suffered as a result of the defendant’s actions. The plaintiff has been given 14 days to file an amended complaint, or the lawsuit will be permanently dismissed. The decision shows that while tracking and analytics tools may result in disclosures of sensitive data to third parties, the plaintiff(s) must demonstrate that the disclosures resulted in a compensable injury.”

From the cybersecurity breaches and vulnerabilities front,

  • Healthcare Dive continues to track healthcare data breaches here.
  • For example, Bleeping Computer notes,
    • “Healthcare software company Unlimited Technology Systems reported that more than 3.8 million people were impacted by a data breach incident that occurred in October 2025.
    • ‘The organization submitted data breach notification samples to the authorities this year on July 1st without revealing the exact number of impacted individuals.
    • “An entry on the breach notification portal of the U.S. Dept. of Health and Human Services now shows that a company server was breached and data of 3,803,750 people was exposed to an unauthorized party.
    • “Unlimited Technology Systems is a software company specializing in providing financial and revenue cycle technology for specialty healthcare providers. According to its website, the firm serves 4,500 clinics and 6,500 specialty healthcare providers across the United States, and processes more than $70 billion in net healthcare charges annually.”
  • The Wall Street Journal reports,
    • “Federal agencies are investigating cyberattacks that targeted more than 30 water systems in Minnesota and utilities in several other states.
    • “Former national security officials say the attacks are consistent with Iran-linked activity, but President Trump rejected that idea.
    • “Small water utilities are vulnerable to hackers because they rely on internet-connected automation but often lack the funding to secure it.”
  • Cyberscoop adds,
    • “The U.S. Coast Guard said it is monitoring the aftermath of a cyberattack that disrupted gate operations at all three of North Carolina’s port facilities this week, though it offered few details as the investigation into the breach continues.
    • “A Coast Guard spokesperson told CyberScoop that the branch’s IT unit was coordinating with partner agencies while conducting the investigation. A spokesperson for CISA did not respond to CyberScoop’s inquiry by press time [on August 7, 2026]. 
  • Security Week points out,
    • “Thousands of data centers are at risk of compromise due to a 22-year-old vulnerability in Baseboard Management Controller (BMC) management processors, data center security firm Lava reports.
    • “Found in most server platforms, BMCs enable server management operations even without a working operating system and typically represent some of the most privileged control points in a data center.
    • “Through a BMC, administrators can power-cycle the host, perform firmware updates, make low-level platform configuration changes, read hardware sensors, and more, using several management surfaces, including the IPMI out-of-band protocol, the Redfish HTTPS-based management API, and a web-based administrative interface.
    • “In many implementations, these interfaces share the same user database. A credential that works for IPMI may also work for the web interface or Redfish API. This matters because the IPMI authentication process can expose information that enables offline password recovery,” Lava notes.”
  • To sum up, Cybersecurity Dive lets us know,
    • “Cyberattacks on operational technology have shifted in recent years from extortion and espionage to destruction, a trend that should alarm those tasked with defending outdated industrial equipment, experts said on Thursday.
    • “The panel discussion at the Black Hat USA cybersecurity conference here highlighted the plethora of risks facing U.S. critical infrastructure operators — many of them poorly staffed and funded — at a time of heightened geopolitical conflict.
    • “OT attacks are increasingly moving from targeting not just data but physical operations,” said Cheri Benedict, a cybersecurity and supply chain adviser at the White House’s Office of the Federal Chief Information Officer.
    • “There is a real desire and willingness to cause this impact at scale,” said Matthew Rogers, the operational technology cybersecurity lead at the Cybersecurity and Infrastructure Security Agency (CISA).”
  • and
    • “Cyberattacks on the healthcare industry have brought hospitals, clinics and other providers to a breaking point, researchers said on Friday.
    • “These are patient safety issues, and yet these types of attacks continue to increase,” Christian Dameff, the co-director of the University of California San Diego’s Center for Healthcare Cybersecurity, said during a presentation at the DEF CON conference here.
    • “The healthcare sector consistently ranks as one of hackers’ top targetsbecause of the sector’s financial constraints, supply-chain opacity and low tolerance for downtime. Cybercriminals have repeatedly broken into hospital chains and healthcare vendors, sometimes causing widespread disruptions and even jeopardizing patient safety.”
  • Cyberscoop adds,
    • “In less than four hours early Tuesday [August 4, 2026], an attacker compromised a GitHub maintainer account and unleashed a self-replicating piece of malware which injected malicious code into more than 440 distinct npm packages, according to multiple security firms. 
    • “The worm, built on the open-source Mini Shai-Hulud repository that TeamPCPpublished in May, was initially let loose in keyv, a data management interface software package with more than 600 million monthly downloads. The attacker spent the next 30 minutes compromising additional packages controlled by the same maintainer, including cacheable, flat-cache, file-entry-cache.
    • “The attack spread to other maintainers, eventually compromising more than 860 packages with a “combined total of over 2 billion monthly installs,” Ilyas Makari, malware researcher at Aikido Security, wrote in a blog post. 
    • “Wiz researchers told CyberScoop it hasn’t observed any new malicious packages since the initial wave moved through a massive footpoint of cloud and code environments in those first four hours.” 
  • Cybersecurity Dive tells us,
    • “Researchers have found fifteen previously unknown vulnerabilities that affect zero-touch provisioning in TP-Link Omada, which is widely used to provision network devices from a central location, according to a report by Forescout Research – Vedere Labs. 
    • “Small to medium-sized companies use the technology to rapidly set up routers and firewalls, which in some cases involves thousands of devices. The technology helps companies save considerable costs when deploying network devices, but it also offers attackers wide access to a lot of systems. 
    • “The research, presented Wednesday [August 5, 2026,] at the Black Hat USA conference in Las Vegas, shows that attackers can chain together vulnerabilities with previously disclosed flaws and infiltrate networks.”
  • and
    • “The malicious use of AI has rapidly accelerated to the point where some threat groups have embedded the technology across their cyber operations, according to a report released Monday [August 3, 2026,]by CrowdStrike. 
    • “China-nexus actors Vault Panda and Genesis Panda have used AI to exploit critical vulnerabilities within 24 hours after a proof-of-concept was disclosed. 
    • “Meanwhile a North Korea-nexus group tracked as Stardust Chollima was able to inject a malicious npm package into 131 trusted Mastra AI frameworks in a supply-chain attack, according to CrowdStrike researchers.” 
  • Per Bleeping Computer,
    • “The Greatness phishing-as-a-service (PhaaS) platform has expanded from credential phishing to adversary-in-the-middle attacks and device-code phishing targeting Microsoft 365 accounts.
    • “The platform has been active since at least mid-2022, targeting Microsoft 365 users in the United States, Canada, the UK, Australia, and South Africa.
    • “It evolved over the years and now targets multiple platforms, including Microsoft 365, iCloud, Yahoo, and Google Workspace.
    • “Currently, it is sold for $289 per month to cybercriminals over a Telegram channel with thousands of subscribers.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • “Ransomware extortion caused roughly three-quarters of business losses in the first half of 2026, the cyber insurance firm Resilience said in a recent report.
    • “At the same time, ransomware accounted for less than 6% of the incidents for which Resilience customers submitted claims, which the company said highlighted how “disproportionately costly” they are.
    • “Other data in the report highlight the importance of proper employee training and vigilant adherence to protocols such as regular backups.”
  • The Register adds,
    • “Ransomware attacks jumped nearly 20 percent in July, with UK firm Comparitech counting 799 incidents, up from 668 in June.
    • “Of those, 51 had been confirmed by victims. The tally makes July the second-busiest month of the year for ransomware, behind March, albeit just barely, when the firm recorded 805 attacks.
    • “The most interesting data after this surging month of attacks is the targets: While news of widespread cyberattacks targeting water infrastructure in the United States may be dominating security headlines lately, those attacks aren’t ransomware, and ransomware attacks on utility companies were actually down 44 percent last month.
    • “In addition to a decline in attacks on utilities, legal firms and government agencies also became less attractive targets, with attacks on those sectors down 31 percent and 11 percent, respectively, Comparitech said.
    • “On the other hand, ransomware attacks increased most heavily in July against finance companies, tech firms, pharmaceutical companies and medical billers, and the education sector, with rates up 71 percent, 62 percent, 46 percent and 44 percent, respectively. 
    • “Those numbers should come as no surprise given what pentesting firm DeepStrike reported about the most frequent payers of ransomware: Manufacturing, education, healthcare, and financial sector firms are the most likely to pay out a ransom, the firm says, with even the least likely (finance) still paying ransoms 51 percent of the time. Ripe targets, in other words.” 
  • Cyberscoop relates,
    • “Researchers said INC ransomware, one of the most active ransomware groups globally, has been the main attacker exploiting a pair of SonicWall zero-days soon after they were disclosed last month.
    • “The prolific ransomware-as-a-service operation wasn’t the first group to exploit the flaws, which were actively exploited for three weeks before the vendor disclosed and patched the defects July 14, but it has been the most assertive and concerning group to target and chain both vulnerabilities together for full access.
    • “Since public disclosure, INC ransomware has emerged as the most commonly named threat actor actively weaponizing this vulnerability chain,” Brett Deroche, director of incident response at Rapid7, told CyberScoop. “While Inc is the name driving the post-disclosure wave, we can’t attribute the full body of exploitation to INC specifically.” * * *
    • “The SonicWall vulnerabilities — CVE-2026-15409 and CVE-2026-15410 — are the latest in a series of security issues confronting the vendor’s customers, including actively exploited zero-days, previously disclosed defects, and an attack last year that allowed a state-sponsored threat group to steal the firewall configurations of every SonicWall customer.” 

From the cybersecurity business and defenses front,

  • The Wall Street Journal reports,
    • “Hasbro CFO Gina Goetter was abroad when a cyberattack hit the company this spring. The day started as planned, but her schedule was wiped clean a few hours later.  
    • “The team “knew something was wrong in the morning,” said Goetter, who is also the company’s COO. “By afternoon, they were aware that it was a breach.” 
    • “The toy and game maker discovered the intrusion in late March. Executives quickly pulled its entire SAP system, which tracks everything from financial to human-resource matters, offline to assess the damage. For three or four days, employees relied on manual workarounds to keep operations moving, forcing Hasbro to delay its first-quarter earnings. 
    • “Company leadership, however, refused to derail certain business operations. * * *Systems were restored faster than anticipated following the cyberattack, keeping costs lower than expected. Hasbro lost roughly $25 million in revenue because of the breach in the three months ended June 28, below the projected $40 million to $60 million hit. The swift recovery allowed the company to quickly terminate third-party legal and accounting support, often a significant part of the costs, according to Goetter.  “We came up faster, which helped,” she said.”
  • SC Media adds,
    • “No, 60% of small businesses don’t fail within six months of suffering a data breach.
    • “That widely circulated figure has been bouncing around for 15 years, but it’s dead wrong, security researcher Adrian Sanabria said Tuesday (Aug. 4) at the BSides Las Vegas hacker conference.” * * *
    • “Sanabria didn’t have any suggestions for companies that are short of cash when an attack or breach happens, other than to have a line of credit at the ready. But he pointed out that transparency and honesty go a long way toward restoring trust after a breach.
    • “Especially in healthcare, he said, “the more transparent you are, the less you’ll get sued for.”
      An audience member cited CrowdStrike as handling its devastating July 2024 bad-update incident very well, with the company leader’s same-day online mea culpa and subsequent apology tour to visit affected clients.
    • “Unfortunately, Sanabria said, many companies of every size still think it’s wiser to not disclose data breaches. That’s mainly out of fear of legal exposure, even though it’s clear that timely and full disclosure is the better policy.
      “Most of the reasons we have for keeping breaches quiet are not good reasons,” Sanabria said. “The model is there, and we know how to do it, but the lawyers won’t let us.”
  • Here’s a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

From Washington, DC,

  • The Senate remains in session this evening while it considers Senator Susan Collins substitute amendment #6732 to H.R.6500, the Senate’s legislative vehicle for a Continuing Resolution to fund the federal goverment from October 1, 2026, through December 11, 2026.
  • Roll Call adds,
    • “Sen. Bill Cassidy of Louisiana said Friday he intended to vote to confirm Todd Blanche to be attorney general, ending a weekslong back-and-forth with the White House to win over GOP holdouts.
    • “All eyes were on Cassidy’s Friday morning floor speech after his fellow Republican Sens. Susan Collins of Maine and Lisa Murkowski of Alaska announced they would vote against Blanche, citing myriad concerns such as the Epstein files, the so-called “anti-weaponization” fund and questions of his independence.
    • “With Sen. Mitch McConnell, R-Ky., still absent after a hospitalization, Senate Republicans could afford to lose only two votes in their ranks if all Democrats vote against Blanche. Had Cassidy not supported Blanche, Majority Leader John Thune, R-S.D., would lack the votes to confirm him before the August recess. Now he can move ahead and hold a final vote on the Senate floor.”
  • and
    • “A bipartisan bill aimed at combating hepatitis C is stalled in the Senate due to a high score from the Congressional Budget Office, the bill’s lead sponsor Bill Cassidy, R-La., said on Thursday.
    • “The bill, co-sponsored by Sen Chris Van Hollen, D-Md., proposes a national strategy to reduce hepatitis C infections by providing free medications and expanding testing for high-risk and vulnerable groups.
    • “Cassidy, chairman of the Senate Health, Education, Labor and Pensions Committee, is a former liver doctor who spent much of his career treating the disease and has said getting this bill across the finish line is a priority before he leaves Congress in January. But the measure has not advanced since its introduction in June 2025, despite bipartisan interest.
    • “There was a score on it that was a disappointing score, but there’s at least some conversations taking place by some with the CBO to get that re-scored,” Cassidy said Thursday afternoon.
    • “Cassidy’s office would not provide the exact figure for the bill’s estimated cost but did say it was higher than a related CBO estimate last Congress.”
  • Govexec points out, “The Senate on Friday confirmed in a 51-47 party-line vote multiple executive branch nominees, including several involved in government oversight and federal employee matters.” 
  • Per an August 5, 2026, AHIMA news release,
    • “AHIMA, a founding member of the Patient ID Now coalition, applauds the Senate introduction of the Patient Matching and Transparency in Certified Health IT (MATCH IT) Act of 2026 by Senators Mark Warner (D-VA) and Jim Banks (R-IN), a companion bill to H.R.2002 introduced in the US House of Representatives by Representatives Mike Kelly (R-PA) and Bill Foster (D-IL).
    • “The MATCH IT Act addresses the problem of patient misidentification within the healthcare ecosystem. The bill would create an industry standard definition for how patient match rates are measured and would improve standardization of patients’ demographic elements entered into certified health IT products to ensure patients are accurately matched with the correct medical record.”
  • FEHBlog observation: Congress should pass this bill.
  • Per an August 6, 2026, White House news release,
    • President Donald J. Trump and Vice President JD Vance are waging war on the fraudsters and scammers who have looted hardworking Americans for far too long.
    • Today, that war becomes fully transparent at fraud.gov — a new website where Americans can track every action, every takedown, and every dollar recovered as part of the unrelenting effort.
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Aug. 7 released a procedural notice on its new pathway to expedite access to certain Food and Drug Administration-designated Class II and Class III devices for Medicare beneficiaries. The Regulatory Alignment for Predictable and Immediate Device coverage pathway, or RAPID, is designed to reduce delays between FDA market authorization and Medicare national coverage determinations. CMS is accepting comments on the procedural notice for 60 days following publication in the Federal Register.”
  • Beckers Hospital Review reports,
    • “The U.S. economy lost 23,000 jobs in July, but healthcare kept adding positions, according to the Aug. 7 jobs report from the U.S. Bureau of Labor Statistics.
    • “Here are [three] things to know from the July jobs report:
      • 1. Healthcare employment continued its upward trend in July, adding 22,000 jobs, though that marked a slower pace than the average monthly gain of 36,000 over the prior 12 months.
      • 2. Hospitals were essentially flat in July, dipping by about 400 jobs after adding roughly 9,500 in June. 
      • 3. Ambulatory healthcare services drove most of the sector’s gains, adding 18,100 jobs, including 4,200 in offices of physicians and 4,600 in home health care services. Nursing and residential care facilities added 4,300 jobs. 
  • Per an August 7, 2026, U.S. Postal Service news release,
    • “The U.S. Postal Service today announced its financial results for the third quarter of fiscal year 2026 (Apr. 1, 2026 – Jun. 30, 2026). Controllable loss, which excludes certain expenses that are not controllable by management, was $1.0 billion for the quarter, compared to controllable loss of $1.6 billion for the same quarter last year.
    • “Net loss for the quarter under generally accepted accounting principles (GAAP) totaled $2.5 billion, compared to $3.1 billion for the same quarter last year. This $562 million decrease is attributed to an operating revenue increase of $1.1 billion along with a decrease in workers’ compensation of $416 million. These are partially offset by increases in retirement benefits of $324 million, retiree health benefits of $195 million, and compensation and benefits of $129 million.
    • “Our results this quarter reflect some progress relative to those areas of the business where we can exercise control, namely with revenue generation, cost control and service improvement,” said Postmaster General David Steiner. “Nevertheless, the Postal Service is today continuing to face a severe liquidity crisis, and our financial losses this quarter reflect systemic challenges inherent in our Congressionally established business model and regulatory framework. We are taking responsible steps to conserve cash to extend our operating window, but we require thoughtful legislative and other actions to establish a financially sustainable Postal Service capable of serving the American public far into the future.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “A Food and Drug Administration advisory committee meeting is scheduled for September to evaluate data for Grail’s Galleri multicancer early detection blood test.
    • “Grail launched Galleri as a laboratory developed test in 2021. Designed to detect signals from multiple cancers using a single blood sample, the MCED test hit a setback in February when a clinical trial missed its primary endpoint.
    • “CEO Josh Ofman told analysts on an earnings call this week that Grail continues to expect Galleri to receive FDA approval in the first part of 2027.”
  • Targeted Oncology tells us,
    • “The FDA has granted fast track designation to BI-1808, a first-in-class anti-TNFR2 antibody, for the treatment of advanced platinum-resistant ovarian cancer in combination with pembrolizumab (Keytruda), according to a news release from BioInvent International AB.”
  • Fierce Pharma informs us,
    • “Fresenius Kabi voluntarily recalled one lot of morphine sulfate injection due to a labeling mix-up with prefilled syringes of the opioid dilaudid that could trigger an overdose resulting in severe respiratory distress or death.
    • “The recall, issued in a letter dated Aug. 4 and posted to the FDA website, is for a single lot of morphine sulfate marketed as Simplist 2 mg/1 ml that was mislabeled and could contain a prefilled syringe of dilaudid 0.5 mg/0.5 ml.”

No Surprises Act News,

  • The American Hospital Association News reports,
    • “Guidance on the implementation timeline for the No Surprises Act independent dispute resolution operations final rule was released Aug. 7 by the Departments of Labor, Health and Human Services, and the Treasury, along with the Office of Personnel Management. The final rule, issued May 28, was designed to streamline communication between group health plans and health insurance issuers, providers and certified IDR entities, while clarifying timelines and processes. The guidance includes details on applicability dates of certain provisions associated with the final rule, including the stand-alone claim adjustment reason codes and remittance advice remark codes guidance.” 

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of August 7, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “Based on multiple data sources, COVID-19 activity is low in many regions but is increasing in the West and South.
    • “RSV activity is very low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV) and respiratory adenovirus are elevated nationally. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The American Hospital Association reports,
    • “A study published Aug. 5 by Nature found that COVID-19 infection can reactivate dormant, chronic viruses such as Epstein-Barr and cytomegalovirus. The study found that reactivation is correlated with the severity of the COVID-19 infection. The study included data from more than 1,100 hospitalized patients with COVID-19 and found reactivation of various Herpesviridae and Anelloviridae viruses. Researchers said that reactivation occurred frequently in “immunocompetent” individuals during severe illness.”
  • The University of Minnesota CIDRAP relates,
    • “Working-age adults living with long COVID feel less satisfied with life, experience less happiness, and have less hope, according to a study published this week in BMC Public Health. The paper highlights the association between having long COVID and poorer wellbeing. 
    • “The findings underscore that the burden of long COVID extends beyond clinical health outcomes to encompass how individuals evaluate and experience their lives,” wrote the authors, from Syracuse University in New York.
    • “Long COVID symptoms were significantly associated with lower levels of subjective wellbeing in a dose-dependent manner.”  
    • “The World Health Organization defines long COVID “as the continuation or development of new symptoms 3 months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least 2 months with no other explanation.”
  • and
    • “The Centers for Disease Control and Prevention (CDC) today confirmed 94 new measles infections—most of them in Pennsylvania—bringing the US total for the year to 2,465, the agency said in its weekly update.
    • “The numbers likely provide additional data to move the United States toward losing its measles elimination status this year. The nation gained that distinction in 2000, but  has now logged consecutive years of more than 2,200 measles cases (2,289 for all of last year). This year’s total is the highest since 1991.”
  • The Washington Post tells us,
    • “Michigan health officials say new cases of cyclosporiasis are declining in the state hit hardest by an outbreak that has sickened more than 12,000 people and left two dead in the state since June. 
    • “The state’s health department said new case reports are slowing and diarrhea-related emergency department visits are trending downward. The drop in cases prompted officials to lift their broad recommendation to avoid bagged salad mixes. But Michigan continues to recommend avoiding recalled lettuce from Taylor Farms de Mexico sourced from central Mexico.
    • “Michigan officials said they believe most of their exposures took place in late June to early July and that most contaminated produce is probably no longer available for consumption.
    • “Cyclospora infections typically cause symptoms about seven days after exposure, although symptoms can take up to 14 days to appear. The health department said residents can now return to routine food-safety guidance for handling and consuming produce, including lettuce and salad greens.”
  • The AP informs us,
    • “In the past year, the U.S. has seen a jump in frequent marijuana users going to the hospital with a nausea and vomiting condition, according to a report released Thursday.
    • “The abruptness and sustained magnitude of the increase” is largely due to the condition getting its own diagnosis code last fall, which is providing a more accurate picture of what was an underrecognized problem, the authors of the U.S. Centers for Disease Control and Prevention report wrote.
    • “Hospital emergency room diagnoses of the condition, cannabis hyperemesis syndrome, rose 16% from last October to May of this year, federal researchers found.
    • “The syndrome — seen in people who frequently use marijuana, especially smokers — is characterized by recurring nausea, uncontrollable vomiting and excruciating abdominal pain.
    • “Past research has suggested that an estimated 2.75 million Americans suffer from it each year, and that hospital emergency room visits have been rising as daily recreational marijuana use has increased.”
  • MedPage Today points out,
    • “Maintaining three key health factors during midlife — normal blood pressure, no diabetes, and not smoking — was associated with nearly 13 additional dementia-free years, a study of 12,000 people in the U.S. showed.
    • “Individuals who met these criteria at age 55 lived an average 30.1 more years dementia-free, reported Josef Coresh, MD, PhD, of NYU Langone Health in New York City, and co-authors.
    • “Conversely, those who smoked, had hypertension, and had diabetes at age 55 had dementia-free survival of only 17.5 years, Coresh and colleagues wrote in Neurology Open Accessopens in a new tab or window.”
  • and
    • “Low-fat vegan diets can help aid in weight loss, but the mechanisms behind this have been unclear.
    • “Adults on a low-fat vegan diet reduced dietary energy density by 30% compared with controls in a secondary analysis of a randomized trial.
    • “Reductions in dietary energy density were significantly associated with greater weight loss after adjusting for overall energy intake.”
  • Medscape adds,
    • “Adding coronary artery calcium (CAC) scoring to risk estimates helped better identify adults at lower and higher risk for atherosclerotic cardiovascular disease (ASCVD) events. People with no detectable CAC had lower observed risk, while those with CAC had higher observed risk, especially when the decision about starting a statin was uncertain.”
  • Healio notes,
    • “Adults with type 2 diabetes and established CVD had lower risk for CV events with tirzepatide [a/k/a Zepbound] compared with sitagliptin [a/k/a Januvia].
    • “Tirzepatide decreased risk for infections leading to hospital admission.
  • Per Genetic Engineering and Biotechnology News,
    • “For people with severe food allergies, avoiding a trigger food like peanuts or tree nuts can mean constant vigilance. Approximately 8% of children and 10.8% of adults in the United States experience some type of food allergy. Even trace exposures can provoke reactions, and while oral immunotherapy can raise the threshold for some patients, the protection often depends on continued treatment and is associated with disease relapse in many patients. A new study suggests that another route to food tolerance may run through the gut microbiome.
    • “In a small Phase I open-label trial (NCT02960074), researchers at Boston Children’s Hospital tested whether oral encapsulated fecal microbiome transplantation (FMT) could safely increase peanut tolerance in adults with peanut allergy. The work, published in Science Translational Medicine, also used mouse models to probe how donor gut microbes might help restore oral tolerance. The study is titled, “Fecal microbiome transplant in food allergy in humans and mice identifies a role for bile acid metabolites in oral tolerance.”
  • The Wall Street Journal adds,
    • “Artificial-intelligence systems have been displaying some eye-opening new abilities in recent weeks: breaking out of their enclosures, hacking other companies, lying to people. 
    • “And now, for the first time, an AI model has created a new virus. A whole family of them, in fact. 
    • “In a study published in the journal Science, researchers at Stanford University and elsewhere said they successfully directed an AI model to create a collection of simple viruses that only infect bacteria and pose no threat to humans.
    • “In an interview, two of the authors said their research could help develop designer viruses that could be used to eliminate drug-resistant bacteria, which according to the World Health Organization kill millions of people every year.
    • “If we develop responsibly, I think it can lead to tremendous benefits in human health,” said Brian Hie, a computational biologist at Stanford and an author of the study.”

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

  • Fierce Healthcare reports, “Insurers see positive results in managing health costs in Q2.”
    • “The health insurance industry weathered a rough 2025, and the turnaround for some companies through the midpoint has surprised even Wall Street analysts.”
  • Beckers Payer Issues adds,
    • “Clover Health posted a $28 million profit for the second quarter of 2026, according to a recent earnings filing.
    • “During the same period last year, Clover logged a $10.6 million loss. The company had its first profitable quarter in 2024.
    • “Total revenue for the second quarter of 2026 was $743.2 million, up nearly 56% year over year. The company attributed the improved results to membership growth and a disciplined approach to administrative spend.
    • “On June 30, Clover had 157,309 members. The company’s benefit-expense ratio dipped to 87.6% this past quarter from 88.4% during the same time in 2025.”
  • and
    • “CVS Health’s pharmacy benefit manager, CVS Caremark, is bringing on Keith Reynolds as chief growth officer.
    • “Chief Sales Officer Jim Fowler will transition into retirement, according to an Aug. 7 LinkedIn post from Mr. Reynolds.” 
  • Beckers Hospital Review relates,
    • “A number of healthcare organizations have recently closed medical departments or ended services at facilities to shore up finances, focus on more in-demand services or address staffing shortages.
    • [The article identifies] 52 department closures or services that are ending or have been announced, advanced or finalized that Becker’s reported since Jan. 1
  • Health Exec adds,
    • “When a nursing home closes down, the local population and press often perceive the move as a simple exit from the market due to failing fiscal health. But in about half the cases, additional forces are in play—and “closures” may be, in truth, do-overs of one kind or another. 
    • “Researchers at the University of Massachusetts fill out the picture with facts in a study published July 31 by JAMA Health Forum.
    • “Joohyun Chung, PhD, RN, and colleagues suggest understanding the dynamics behind nursing-home closings is important because such events can disrupt continuity of care, place additional burdens on remaining facilities and disproportionately affect vulnerable populations.” 
  • Fierce Pharma tells us,
    • “Injected weight loss drugs remain favored over newer oral treatments by a significant margin, with Eli Lilly’s Zepbound leading the pack, according to a survey of healthcare specialists by Spherix Global Insights.
    • “In the poll, which includes input from 185 specialists in the United States, 80% were highly satisfied with Zepbound, compared with 59% for Novo Nordisk’s rival injectable, Wegovy. Though it remains early in the launches of Novo’s oral version of Wegovy and Lilly’s GLP-1 pill Foundayo, 48% and 47% of those surveyed were highly satisfied with the newer products, respectively.”
  • and 
    • “Prescriptions for Eli Lilly’s Foundayo continue to build, jumping 16% sequentially to 34,219 the previous week, according to IQVIA data cited by Citi. The oral GLP-1 med has been on a roll lately as it appears to celebrate four weeks of consecutive growth in total scripts. However, as Citi noted, there’s still a potential gap in IQVIA’s capture of telehealth data, and it’s not clear how much of the scripts growth was from IQVIA getting better at including those data, or, if the actual growth was much faster in telehealth channels.
    • “This week, Lilly’s reported Foundayo sales for the second quarter—$98 million in total, including $67 million in the U.S.—disappointed many. As CEO David Ricks noted on an earnings call, Lilly began broad direct-to-consumer marketing to raise consumer awareness after securing commercial access across the three major pharmacy benefit managers in June. Besides, The Medicare GLP-1 Bridge program went live on July 1, offering coverage for certain weight-loss medications, including Foundayo, for a $50 copayment per month. Ilya Yuffa, president of Lilly USA and global customer capabilities, said the company is “starting to see an inflection point on Foundayo now.”
    • “As for Novo Nordisk’s Wegovy pill, total scripts recorded by IQVIA have been largely flat with small upticks in the past two weeks, having reached roughly 172K in the previous week. The oral version of semaglutide now makes up 35% of total Wegovy scripts, which take up about 40.6% of the U.S. obesity market share, as Lilly’s Zepbound remains the leader.” 
  • Fierce Healthcare informs us,
    • “Despite the rapid implementation of artificial intelligence solutions across the healthcare industry, many organizations are still working on establishing necessary infrastructures and governance foundations, a new report from UPMC’s Center for Connected Medicine and KLAS Research found.
    • “Ninety-three percent of respondents report that their organizations deploy third-party AI solutions, though only 44% have a dedicated data platform or environment for tool testing. But 92% of respondents report testing third-party tools prior to deployment.
    • “What’s emerging from this research is a clear recognition that implementation is only the first step,” said Rob Bart, M.D., UPMC chief medical officer, in a statement. “Health systems are now focused on building the governance structures, testing capabilities and organizational strategies necessary to ensure AI delivers meaningful and measurable value.”
    • “The “Validation and Trust: The Governance of AI Solutions at Health Systems” report drew insights from 27 healthcare leaders, including those from health systems and ambulatory care organizations.” 
  • Healio adds,
    • “Many patients report high comfort with health systems using AI-written portal messages, noting it gets them information quickly and reduces clinician workload.
    • “Their comfort comes with caveats, though. Patients want both clinician oversight and transparency that AI is being used.”

Friday report

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

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “The timeline is slipping for senators to strike a bipartisan deal on a short-term funding patch before their August recess as leadership struggles to work out the finer details.
    • “Senior appropriators had been hopeful of unveiling text before the weekend for a stopgap measure expected to keep the government funded into early December. But sources say leaders are now more likely to release text later this weekend or early next week amid snags over a federal grant rule and other add-ons.
    • “The Trump administration’s proposed rule would give senior political appointees greater influence over the grant approval process and has drawn pushback from appropriators on both sides of the aisle.
    • “Senate Appropriations Chair Susan Collins, R-Maine, noted Thursday that the rule has drawn considerable criticism from “a wide range of groups.”
    • “So, I hope we’ll take advantage of this opportunity to delay it,” she said. “But that’s up to the leadership. It’s obviously not a funding issue.”
    • “The grants dispute is among the last-minute hitches and “anomalies” that negotiators have said leadership is sorting through as senators aim for floor consideration next week.
    • “The Senate is currently scheduled to take a procedural vote Monday on the legislative vehicle for the continuing resolution that is needed to stave off a partial government shutdown on Oct. 1, when the new fiscal year begins.
    • “The House has already passed a Republican-crafted stopgap bill to extend current funding through Dec. 4. But senators say further “anomalies,” or deviations from current spending, are needed, noting the gap between add-ons requested by the White House and the House GOP’s bare-bones funding patch.”
  • Bloomberg Law relates,
    • “The Trump administration will increase Medicare payments for hospital services by 2.3%, or $2.1 billion in fiscal year 2027, according to a final rule released Friday.
    • “The final rule (RIN 0938-AV79) from the Centers for Medicare & Medicaid Services also includes a 2.2% reimbursement bump of $54 million for long-term care hospitals, along with several new hospital quality reporting measures.
    • “These include the adoption of quality measures for diabetes, deep vein thrombosis/pulmonary embolisms, quality care planning, and mortality rates. 
    • “The final rule also expands the agency’s Comprehensive Care for Joint Replacement (CJR) Model, which holds hospitals financially accountable for the quality and cost of hip, knee, and ankle replacements, through incentive payments
    • “The agency says the program has produced strong evidence of cost savings while maintaining quality of care. 
    • “The mandatory model will now be expanded nationwide beginning Jan. 1, 2028.”
  • Beckers Hospital Review points out nine things to know about today’s rule.
  • Here’s a link to CMS’s Fact Sheet on today’s rule.
  • The American Hospital Association News adds.
    • “The Centers for Medicare & Medicaid Services today finalized a 2.3% payment update for long-term care hospitals for fiscal year 2027 relative to FY 2026. This includes a 3.2% market basket update, reduced by a 0.9 percentage point productivity adjustment. In addition, CMS finalized its decision to freeze the outlier threshold at $78,936, the same level as FY 2026. For the LTCH Quality Reporting Program, CMS finalized the removal of two measures related to COVID-19 vaccination and a shortened data reporting timeline.
    • :In a statement shared with media today, Joanna Hiatt Kim, AHA’s vice president of payment policy, said, “[W]e remain concerned about continued inadequacies in the LTCH payment system that have contributed to declining patient volumes and the closure of facilities across the country, threatening access to care for medically complex patients. Although the AHA appreciates that CMS did not further raise the outlier threshold in this final rule, broader reforms are needed to support the LTCH field. We remain committed to working with the Administration and Congress to advance the AHA’s LTCH reform principles and promote a more sustainable payment framework that preserves patient access to LTCH services.”
  • The American Hospital Association News further informs us,
    • “The Department of Health and Human Services today issued a notice announcing a revised 340B Rebate Model Pilot Program, allowing qualifying drug manufacturers to use rebates rather than upfront discounts to effectuate the 340B ceiling price for certain drugs purchased by 340B covered entities. 
    • “In a statement shared with the media, AHA President and CEO Rick Pollack said, “The AHA is deeply concerned that HHS has chosen to move forward with a 340B Rebate Model Program despite the overwhelming evidence that it will impose massive new administrative and financial burdens on hospitals that serve America’s most vulnerable patients. The agency’s analysis dramatically understates the true costs of this program, ignoring the hundreds of millions of dollars in compliance expenses, cash-flow disruptions, and operational burdens that will inevitably divert scarce resources away from patient care. At a time when many hospitals are already under severe financial strain, this policy will force hospitals in rural and other underserved communities to spend more on bureaucracy and less on the services and care that patients depend on every day. As we continue to review today’s notice, the AHA is considering all available options to prevent this flawed program from going into effect.” 
    • “HHS’ Health Resources and Services Administration said the pilot is designed to test a rebate-based approach for a set of drugs while gathering information on program integrity, operational impacts and the interaction between the 340B program and Medicare’s Drug Price Negotiation Program. The pilot is limited to drugs included on the Centers for Medicare & Medicaid Services Medicare Drug Price Negotiation Selected Drug Lists for initial price applicability years 2026 and 2027. 
    • “Under the notice, manufacturers that wish to participate must submit plans to HRSA by Aug. 24. HRSA said it will make approval decisions by Sept. 24, and approved rebate models will take effect Jan. 1, 2027. Participating manufacturers must commit to the pilot for at least one year. “
  • Per an HHS news release,
    • ‘The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), announced today that it has awarded $73.2 million in grants to strengthen children’s mental health services, suicide prevention programs, and to expand assisted outpatient treatment (AOT) to those with serious mental illness.”
  • OPM posted in the Federal Register today direct final rules (previously known as interim final rules with opportunity for public comment)
    • FLSA Claims and Compliance
      • to update the provisions concerning Fair Labor Standards Act (FLSA) claims submissions to OPM.
      • DATES: This direct final rule (DFR) is effective September 29, 2026 unless significant adverse comment is submitted by August 31, 2026. If OPM receives significant adverse comment, OPM will publish a timely withdrawal in the Federal Register.
  • and
    • Procedures for settling claims
      • to update the provisions concerning administrative claims submissions to OPM.
      • DATES: This direct final rule (DFR) is effective September 29, 2026 unless significant adverse comment is submitted by August 31, 2026. If OPM receives significant adverse comment, OPM will publish a timely withdrawal in the Federal Register.
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today issued governmentwide guidance to departments and agencies on preparing Fiscal Year 2027 Annual Staffing Plans, advancing the Trump Administration’s efforts to modernize federal workforce planning, strengthen merit-based hiring, and ensure agencies are strategically positioned to deliver efficient, high-quality services to the American people.
    • “The guidance implements Executive Order 14356, Ensuring Continued Accountability in Federal Hiring, and provides agencies with a framework for conducting rigorous, bottom-up workforce planning that prioritizes mission-critical positions, modern technology talent, and early career hiring while improving governmentwide visibility into staffing needs.
    • “Annual Staffing Plans will require agencies to identify workforce needs based on mission requirements—not historical staffing levels—and reserve budget and positions for critical hiring priorities, including artificial intelligence, cybersecurity, software engineering, and other technology roles. The guidance also directs agencies to leverage governmentwide hiring initiatives such as US Tech Force and the Early Career Talent Network to improve hiring quality, reduce duplication, and accelerate recruitment across the federal government.”
  • Kevin Moss, writing in Federal News Network, explains “How a household with two federal employees can save on their FEHB premiums by enrolling self-only.”

From the Food and Drug Administration front,

  • Cure reports,
    • “The Food and Drug Administration (FDA) has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, a disease previously known as metastatic hormone-sensitive prostate cancer.
    • “The July 31 approval expands the use of Pluvicto to patients whose prostate cancer has spread but has not yet become resistant to hormone therapy. The treatment is intended for patients whose tumors express prostate-specific membrane antigen (PSMA), a protein found on many prostate cancer cells.”
  • MedTech Dive relates,
    • “Surgical robotics company MMI has received the Food and Drug Administration’s approval to expand an early feasibility study of microsurgery for Alzheimer’s disease.
    • “The REMIND study is evaluating the safety and feasibility of using MMI’s Symani robotic system in microsurgery procedures to re-establish drainage pathways in the deep cervical lymph nodes of patients with neurodegenerative disease. Patients in the trial also have confirmed lymphatic abnormalities.
    • “The FDA gave MMI the go-ahead to expand the number of people who can enroll in the study to 15, from up to five in the initial group, the company said Thursday.”
  • The American Journal of Managed Care lets us know,
    • “Late last week] six peptides received narrow advisory support for potential 503A Bulks List inclusion, an atypical outcome given FDA staff recommendations against all seven under review. 
    • “Legal compounding remains prohibited absent FDA acceptance and completion of proposed and final rulemaking; none of the substances is FDA-approved. 
    • “FDA reviewers cited short, underpowered studies insufficient for safety/efficacy across proposed indications, including limited BPC-157 trial data. 
    • “Committee reconstitution drew conflict-of-interest scrutiny, with increased representation from clinicians and businesses involved in prescribing, producing, or promoting peptides. 
    • “Payers should expect persistent cash-pay utilization and unregulated online procurement, necessitating rigorous medication reconciliation and adverse-event monitoring given sparse human safety data.”

From the judicial front,

  • Per a Justice Department news release,
    • “New York ophthalmology practices Mark D. Fromer, P.C. doing business as Fromer Eye Centers and Floral Park Ophthalmology P.C. have agreed to pay a total of $2.3 million to resolve alleged violations of the False Claims Act arising from their billing for trans-cranial doppler ultrasounds (TCDs) through a kickback arrangement with a third-party testing company. The Estate of Mark Fromer, the former owner of Fromer Eye Centers, also joined in the settlement with the practice. Both practices have agreed to cooperate with the Justice Department’s ongoing investigations of other participants in the alleged scheme.” * * *
    • “The claims resolved by the settlements are allegations only and there has been no determination of liability.“

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of July 31, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “Considering multiple data sources, COVID-19 activity is low and stable nationally but is beginning to show early signs of an increase in the West and South.
    • “RSV activity is very low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV) and respiratory adenovirus are elevated nationally. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The University of Minnesota CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) confirmed 53 new US measles cases this week, bringing the total for the year to 2,371 cases.
    • “All but 16 of the cases were locally acquired in 45 US jurisdictions, with the rest tied to international travel, the CDC said in its weekly update. There have been 37 new measles outbreaks reported this year, with 94% of cases associated with outbreaks (defined as three or more cases).” * * *
    • “Among the current measles hotspots is Pennsylvania, which has reported 31 new cases over the past seven days and now has 167 cases for the year, according to the Pennsylvania Department of Health. Officials in neighboring Ohio yesterday confirmed four new cases in unvaccinated individuals in Ashtabula and Tuscarawas counties. It’s Ohio’s third measles outbreak this year.”
  • The American Journal of Managed Care gives us “FAQs: Cyclospora Recovery, Treatment, and Outbreak Prevention Strategies.”
    • “Epidemiologic and traceback evidence implicates shredded iceberg lettuce from Taylor Farms de Mexico as the exposure source, despite a disclosed false-positive border test not changing investigation conclusions. 
    • “Symptom onset typically occurs about one week post-exposure and includes profuse watery diarrhea, anorexia, nausea, bloating, weight loss, and fatigue, while some infections remain asymptomatic. 
    • “Higher-risk groups include immunocompromised patients, older adults, and those with limited care access, who may need longer antibiotic courses and closer monitoring for dehydration and prolonged illness. 
    • “TMP-SMX is the treatment of choice but requires individualized risk–benefit assessment given adverse reactions and a clinically meaningful, though comparatively lower, association with C difficile. 
    • “Public health control relies on clinician/lab case reporting, standardized exposure questionnaires, and FDA traceback; absent whole-genome sequencing for Cyclospora, marker-based genotyping supports source identification.”
  • The Wall Street Journal adds,
    • “In the verdant fields of California’s Salinas Valley, Larry Cox is watching his lettuce wilt.
    • “Cox and his two sons run Coastline Family Farms, which supplies leafy greens to some of the country’s biggest restaurant chains and grocery stores. But this week, in the region known as America’s Salad Bowl, around 300,000 pounds of his romaine hearts were chopped and plowed back into the soil.
    • “There is no evidence that his, or any of the nation’s homegrown lettuce, was infected with the parasite behind an illness outbreak that has sickened thousands of people so far. Even so, that hasn’t stopped Cox’s dependable restaurant and grocery customers from cutting back on orders.
    • “Many growers are destroying the crops they can’t find buyers for. Since lettuce has about a 30-day growing cycle, farmers that are plowing their crops back into the ground are weighing whether to replant or dial back. 
    • “It is incredibly demoralizing,” Cox said. “I would’ve been better off taking a vacation in the South of France than planting the crop.”
  • USA Today relates,
    • “As electric bikes and scooters become an increasingly common way for young people to get around, injuries tied to the devices are climbing at an alarming rate.
    • “New research from Truveta, a health data and analytics firm supported by a coalition of 30 U.S. health systems, analyzed over 12,000 emergency room visits nationwide. The findings revealed that injury rates associated with e-bikes and e-scooters among children and adolescents surged 7.5-fold between January 2023 and May 2026, an increase compared to the rates seen in adults.
    • “ER visits related to e-bikes and e-scooters have increased by 671% for children and adolescents, said Karen Gilbert Farrar, PhD, lead researcher at Truveta. “Just to put that in context, that’s if one patient is was being seen in 2023, that’s now nearly eight patients in 2026.”
    • “The findings also highlight the severity of many crashes: more than one-third of injured patients suffered head or neck injuries. And nearly 7% of child and adolescent visits that were related to e-bike and e-scooter use involved traumatic brain injury, Farrar said.”
  • Health Day lets us know,
    • “E-cigarettes could be reshaping the future of cancer in the United States, by offering people a less-toxic option than smoking, a new study argues.
    • :Smokers are increasingly switching to vaping and other forms of nicotine use, researchers reported July 27 in the journal JNCI Cancer Spectrum.
    • :They’re also sticking with their vapes, rather than swapping back and forth with tobacco cigarettes, researchers found.
    • “Our results show that exclusive cigarette use is being replaced by exclusive use of other combustible products, mainly e-cigarettes, especially among young adults,” said lead researcher Kenneth Michael Cummings, in a news release.”
  • and
    • “Work stress could be eating away at the sleep of most middle-aged working folks, undermining their health, a new study says.
    • “Nearly 70% of a small group of people ages 50 to 66 experienced persistent sleepproblems, even though they had no history of sleep disorders, researchers reported July 28 in the journal Scientific Reports.
    • “Even more concerning, more than 9 out of 10 (92%) of the participants met the clinical threshold for a sleep disorder at least once during the yearlong study, researchers said.
    • “I was genuinely surprised by the sheer scale of sleep problems we uncovered in this otherwise undiagnosed group,” lead researcher Athanasios Tsanas said in a news release. He is a professor of digital health and data science at the University of Edinburgh in the U.K.”
  • BioPharma Dive tells us,
    • “A Novo Nordisk heart drug missed the main goal of a Phase 3 trial, failing to show it prevented heart attacks, strokes or cardiovascular death in people with hardened arteries or chronic kidney disease, the company said Friday.
    • “Called ziltivekimab, the drug is part of a sprawling clinical program involving three late-stage trials that have collectively enrolled more than 20,000 people. Two others, in people with heart failure or who’ve had an acute heart attack, are ongoing. Results are expected next year. They all aim to show lowering levels of an inflammatory protein called IL-6 can can reduce the risk of heart-related complications and death.
    • “Novo gained control of ziltivekimab through a 2020 acquisition of Corvidia Therapeutics, for which it paid $725 million up front and promised up to $2.1 billion in total payouts. Novo said it will take a “non-cash impairment charge” in the third quarter but will not need to change its operating profit forecasts.” 

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

  • Fierce Healthcare reports,
    • “Cigna executives offered investors a look at the progress the company has made in the rollout of its new Signature pharmacy benefits model, which moves away from traditional drug rebates.
    • “CEO Brian Evanko said during the company’s earnings call that the team is “making strong progress in the build-out” of the model. It will roll out to Cigna Healthcare’s fully insured plans in 2027, before a wider launch in 2028.
    • ‘In particular, the model is designed around the affordability of brand-name drug products, and the company projects that it could save members 30% per month on branded medications. Through Signature, tech platforms will surface the lowest price to the member at the pharmacy counter, even if that’s a cash-pay option or provided by a manufacturer’s direct-to-consumer programs.
    • “We see significant early interest from health plans and employers as we prepare for our broader market launch in 2028,” Evanko said. “At the same time, we’re adding value and winning business today, with 2027 representing one of our strongest selling seasons in recent years.”
  • and
    • “Alignment Healthcare delivered a strong second quarter, in what CEO John Kao said was supported by the deployment of its new artificial intelligence-powered stratification model.
    • “This advancement improved our ability to predict which members are going to be hospitalized,” Kao said. “Our model now accurately and dynamically predicts the 10% of members who will account for nearly 70% of hospital admissions over the next 30 days.” 
    • “Kao said the on the company’s Thursday earnings call it plans to “reinvest a portion” of savings to areas that produce “tangible, measurable returns,” including market expansions, branding and “deepening AI capabilities.
    • “Beyond its potential to unlock efficiencies in our cost structure, AI represents a meaningful opportunity to further enhance our care model and support providers,” Kao said. “Most importantly, our approach to AI is grounded in decades of clinical expertise and reinforces our commitment to high-quality care. This is further supported by a governance framework to ensure responsible use, human accountability, and equitable treatment of our members.” 
  • Healthcare Dive relates,
    • “Siemens Healthineers has struck a 10-year deal to support diagnostic imaging, cardiology and radiation oncology at Cleveland Clinic, the company said Thursday.
    • “Building on its 35-year relationship with the academic medical center, Siemens Healthineers will provide diagnostic imaging and therapeutic technologies, including magnetic resonance imaging, computed tomography, radiation oncology, interventional radiology and X-ray.
    • “Siemens Healthineers is expanding an existing team dedicated to Cleveland Clinic, adding on-site technicians and training personnel to its current group of more than 30 people.”
  • Beckers Hospital Review points out,
    • “A total of 438 urban hospitals closed across the U.S. between 2000 and June 2026, according to data shared with Becker’s from New Haven, Conn.-based Yale University’s Health Care Affordability Lab.
    • “Between 2001 and 2023, the period for which both openings and closures are fully tracked, urban hospitals posted a net gain of 11 nationally, with 396 openings and 385 closures. However, there were significant losses in individual states. New York lost a net 33 urban hospitals over that period, California lost 29 and Pennsylvania lost 24.
    • “The data covers general, short-term acute-care hospitals and excludes specialty facilities such as psychiatric, rehabilitation, children’s and VA hospitals. Urban and rural classifications follow the census-tract-level definition from the Health Resources & Services Administration’s Federal Office of Rural Health Policy.
    • “The tables [found in the article] show urban hospital net change by state from 2001 to 2023 and total urban closures by state from 2000 through June 2026. States with no urban hospital activity in the Yale dataset are not listed.
  • Fierce Pharma informs us,
    • “The small inflection point we noticed two weeks ago regarding Eli Lilly’s Foundayo does not appear to be a flash in the pan. Weekly total prescriptions for the small molecule reached 29,388, a new high for the oral GLP-1 receptor agonist after three weeks of consecutive growth, according to IQVIA data cited by Citi. 
    • “As IQVIA may be missing some scripts from telehealth channels, we will get a clearer picture of Foundayo’s launch progress when Lilly reports its second-quarter earnings on Wednesday, Aug. 5. Analysts at Jefferies have been modeling $71 million in U.S. sales for the quarter based on IQVIA data.
    • “Meanwhile, Novo Nordisk’s Wegovy pill remains far ahead in the oral GLP-1 race with total scripts also hitting a new record of about 171,700, according to Citi. The number represents 1.1% growth from its previous best recorded during the prior week.
    • “Coincidentally, the entire GLP-1 class also saw its total scripts grow 1.1% sequentially across diabetes and obesity uses. Lilly’s Zepbound regained some lost ground with total scripts up 1.9% week over week. That’s compared to Wegovy, which now makes up 40.6% of the obesity market after a 0.2% sequential decline in total scripts.” 
  • Per Fierce Healthcare,
    • “WellSpan Health inked an expanded multi-year partnership with artificial intelligence company Hippocratic AI, which expands AI-powered capacity across the network.
    • “Through the update, Hippocratic AI’s generative AI agent—Ana—will expand from handling inbound calls and primary care appointment scheduling to post-discharge follow-up and chronic disease check-ins.
    • “Initial workflows will focus on closing care gaps through outreach to patients with missed imaging appointments, executives say. Every new use of the AI agent will follow governance, safety and implementation structures in coordination with WellSpan teams.
    • “WellSpan Health CEO Roxanna Gapstur, Ph.D, said in a statement the future of the industry will “be shaped by the organizations that build the culture, governance and clinical capabilities” to utilize AI responsibly at scale.
    • “At WellSpan, we’ve been intentional about creating this foundation, so innovation advances safely, strengthens clinical excellence and earns trust,” Gapstur said. “Our expanded partnership with Hippocratic AI is an investment in the future of care — one that expands access, supports our care teams and creates a more personalized experience for every patient we serve.”

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

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

From the Food and Drug Administration front,

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

No Surprises Act news,

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

From the judicial front,

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

From the public health and medical/Rx research front,

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

From the U.S. healthcare business front,

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