Monday report

Mental health care

Monday report

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

Simplicity is a virtue.

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / research front,

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

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

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

Friday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, HSA, Medical / Rx research, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The House of Representatives Budget Committee lets us know,
    • “A new report from the Department of Health and Human Services’ Office of the Assistant Secretary for Planning and Evaluation (ASPE) finds reforms to Medicaid provider taxes and state-directed payments in The One Big Beautiful Bill will lower health care prices for Americans across the board.
    • “The report projects the reforms will reduce non-Medicaid health care prices by as much as 3.5 percent, generating between $502 billion and $875 billion in savings for taxpayers, families, and businesses over the next decade, with annual savings reaching $100 to $175 billion once the reforms are fully in place.
    • “The savings extend beyond Medicaid: ASPE estimates that every $100 billion in Medicaid savings produces another $29 billion in savings for Medicare and commercial coverage plans, which lowers health care costs and the tax burden for hardworking American families.”
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced that health systems represented by the past, current, and incoming chair of the American Hospital Association (AHA) have joined the Make Hospital Food Healthier Pledge, strengthening a nationwide effort to improve the quality of food served in America’s hospitals and reinforce the role of nutrition in patient care. Corewell Health in Michigan, Houston Methodist in Texas, and Sanford Health in South Dakota all signed onto the pledge.
    • “Hospitals cannot promote healing while serving food that contributes to chronic disease,” said HHS Secretary Robert F. Kennedy, Jr. “By joining this pledge, these health systems are putting nutrition where it belongs — at the center of patient care. We are working with hospitals across America to serve healthier food, improve patient health, and Make America Healthy Again.”
  • Fierce Healthcare reports,
    • “The Pharmaceutical Care Management Association announced Thursday that its members had reached an agreement with the feds to offer information on cash prices available through TrumpRx.
    • “The commitment encompasses nine of the industry’s leading pharmacy benefit managers, including the “Big Three” in CVS’ Caremark, UnitedHealth Group’s Optum Rx and Cigna’s Express Scripts. Other participants that have signed on include Elevance Health’s CarelonRx, Humana, MedImpact Healthcare Systems, Navitus Health Solutions, Prime Therapeutics, VtylOne and WellDyne.
    • “Members covered by these PBMs will be able to see costs for drugs purchased through TrumpRx when using their plan’s real-time benefit or other pricing tools, PCMA said.”
  • McKnight’s Homecare relates,
    • “In a new memo outlining the National Fraud Enforcement Division’s enforcement priorities in a variety of industries, the Department of Justice called out home health and hospice fraud as an area of focus in the healthcare sector.
    • “National healthcare expenditures are expected to grow from over $3 trillion a year to over $7 trillion, and estimates are that between 3–10% of that amount is lost to fraud,” the Aug. 13 memo from Colin M. McDonald, assistant attorney general, said. “Home health aide and hospice scams directly impact vulnerable elderly Americans and erode patient care.”
  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services Aug. 14 released a request for comments through the Office of the National Coordinator for Health IT on a proposed three-year generic clearance to collect routine customer feedback on service delivery and performance related to the Trusted Exchange Framework and Common Agreement. TEFCA is a nationwide network for health information sharing established by ONC to fulfill mandates under the 21st Century Cures Act. HHS said data collection under the clearance would be used to standardize monitoring and performance reports for TEFCA participants. Comments are due 30 days following publication in the Federal Register.”

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

  • Govexec reports,
    • “Federal wildland firefighters will soon have more opportunities to receive hazard pay in connection with their work fighting and preventing wildfires, thanks to newly finalized regulations from the Office of Personnel Management.
    • “Currently, federal firefighters are eligible for hazard pay—a 25% increase over their normal salary—only when working to extinguish an unplanned wildfire. But they do not receive this increased pay when working on prescribed burns, in which officials intentionally ignite decaying forest material in the hopes of mitigating the risk of an uncontrolled wildfire breaking out in the future.
    • “In a new rule published in the Federal Register Friday, OPM finalized its April proposal to expand firefighters’ access to hazard pay to include prescribed burns, effective Sept. 13. The regulation authorizes hazardous duty pay for prescribed burns for firefighters hired under the “General Schedule pay sale, as well as environmental differential pay for those serving under the Federal Wage System.
    • “But OPM noted that the new hazard pay will not be available for every activity associated with a prescribed burn.
  • Also in today’s Federal Register, OPM issued a new direct final rule. Here is the summary and comment information:
    • SUMMARY: Pursuant to the President’s direction in Executive Order 14410, Implementing Schedule Policy/Career in the Excepted Service, the Office of Personnel Management (OPM) is issuing a direct final rule to update and amend obsolete and outdated provisions of the
    • Civil Service Rules that do not substantively affect agency operations.
    • DATES: This rule is effective October 13, 2026, unless significant adverse comments are received by September 14, 2026. If significant adverse comments are received, OPM will withdraw the relevant provisions of this direct final rule.
  • Federal News Network relates,
    • “Retirement is supposed to be the payoff for decades of saving, planning and serving the federal government. But for some federal employees, the first year of retirement can bring surprises they never saw coming, whether that be a delayed pension, a tax bill that looks very different from what they expected, anxiety about spending the money they’ve saved for decades, and decisions that can affect a spouse’s benefits for years to come.
    • “On this episode of Fed Thread [which the article summarizes], we called back our three financial professionals—James Campbell of Federal Employees Benefit Association, Katelyn Murray of RJFS and Serving Those Who Serve, and Chris Campbell of CJC Wealth Management and the DC Society for Financial Awareness—to talk through the financial and psychological traps feds may encounter before or after their last day. Because retirement isn’t just the day your paycheck stops. It’s the beginning of a completely different financial system.”

From the Food and Drug Administration front,

  • The Washington Post informs us,
    • “About 1.5 million dozen white and brown cage-free eggs recalled for potential salmonella contamination have been upgraded to the U.S. Food and Drug Administration’s highest-risk warning. 
    • “The agency reclassified the recall of Midwest Poultry Services eggs to Class I due to the reasonable possibility that exposure to the product would cause serious health issues or death, it said in a safety alert. 
    • “Salmonella is a bacteria that can cause diarrhea, vomiting, fever and stomach pain.
    • “The eggs were available to consumers in Brookshire Grocery stores in Texas, Louisiana, Oklahoma, Arkansas, New Mexico and Mississippi. Other locations include Kroger stores in Texas and Louisiana, as well as other small retail outlets, the FDA said.”
  • The UPI reports,
    • “U.S. health officials said they have begun inspections at the Mexican processing plant of the U.S. food distributor Taylor Farms as they deal with a continuing cyclosporiasis outbreak that has spread across 17 states.
    • “The Food and Drug Administration and the Centers for Disease Control and Prevention announced Thursday they have “initiated an onsite inspection and sampling” at Taylor Farms de Mexico’s facility in Guanajuato, Mexico, located about 185 miles northwest of Mexico City.”
  • The University of Minnesota’s CIDRA adds,
    • “The best-if-used-by dates of recalled iceberg lettuce associated with the massive Cyclospora outbreak have passed, according to an update from the US Food and Drug Administration (FDA) yesterday. This means that Cyclospora-tainted Taylor Farms lettuce should no longer be available at stores and restaurants.” 
  • Radiology Business relates,
    • “The U.S. Food and Drug Administration has approved a new brain imaging agent targeted toward Alzheimer’s, drugmaker Lantheus announced Friday. 
    • “Tauklarify, also known as MK-6240, is a radiodiagnostic agent indicated for PET (positron emission tomography) imaging of adults. Ideal candidates have cognitive impairment, with physicians evaluating them for abnormal buildup of tau—twisted, insoluble protein fibers in brain cells—a potential sign of the neurodegenerative disease. 
    • “Bedford, Massachusetts-based Lantheus—which recently reached a deal to be sold to rival Curius for $8 billion—said the drug’s safety was tested in two clinical trials. Across over 1,700 subjects, researchers reported strong results, with only about less than 1% of subjects experiencing adverse reactions.”

No Surprises Act News

  • The Centers for Medicare and Medicaid Service posted a notice today (Dropbox link) about implementation of changes to the Independent Dispute Resolution Gateway required by a recent final rule.
    • “Organizations and individuals thatprocess disputes, represent parties, or submit IDR web forms in the current Federal IDR process must sign up to manage disputes in the IDR Gateway. If a party uses a third-party administrator or another organization to process disputes, the party does notneed to sign up for the IDR Gateway but must ensure the third-party administrator or organization responsible for managing dispute processing activities signs up for an IDR Gateway account.
    • “Details about signing up for the IDR Gateway are coming soon. Until then, continue using the Federal IDR web.” 

From the judicial front,

  • The Wall Street Journal reports,
    • “Luigi Mangione, whose coldblooded killing of an insurance executive on a Manhattan sidewalk rattled the nation and struck fear into Corporate America, pleaded guilty Friday to two federal stalking charges in the death of UnitedHealthcare leader Brian Thompson.
    • “On the morning of Dec. 4, 2024, I shot Mr. Thompson in Manhattan and he died,” Mangione solemnly told the judge during a court hearing.
    • “Mangione, wearing tan jail garb, told the judge that he spent years enduring severe pain, including a broken back, and witnessed others with similar experiences. He said that after learning of an investor conference, he emailed UnitedHealthcare, posing as an investor at a firm managing over $50 million in assets, to request information about it.
    • “Unlike my previous interactions with insurers, I received an immediate response within an hour,” Mangione added. He said he made part of a gun using a 3-D printer and planned the killing.
    • “U.S. District Judge Margaret Garnett said Mangione faces up to life in prison at his sentencing, which she set for December. Jamie McDonald, the U.S. attorney for the Southern District of New York, said after Friday’s hearing that his office intended to seek the maximum penalty, saying Mangione committed the crime in order to “draw public attention to his dislike of certain businesses.” 
    • “No grievance, political belief or ideological cause can ever justify murder,” McDonald said. “There can be no celebrity in assassination.”
  • FEHBlog observation: Well put observation, Mr. McDonald.
  • Healthcare Dive tells us,
    • “A patient advocacy group is going up against the most powerful doctor’s association in the U.S. in a bid to wrest away its ownership of U.S. medical codes and release them into the public domain.
    • “On Thursday, PatientRightsAdvocate.org sued the American Medical Association, challenging its copyright over the current procedural terminology, or CPT, billing code system, which shapes billions of dollars in healthcare payments every year.
    • “The goal of the lawsuit is to get the codes published online and let the public access them for free, the group, which lobbies for better price transparency in healthcare, said. Currently, the AMA charges licensing fees to retrieve and use CPT codes.”
  • FEHBlog observation — It’s no problem looking up CPT Codes on the internet.

From the public healh and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of August 14, 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.
    • “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’s CIDRAP reports,
    • “With 101 newly confirmed measles cases nationwide, the US total has now reached 2,566 this year, the Centers for Disease Control and Prevention (CDC) said today in its weekly update.
    • “This is the second straight week of about 100 new cases after previous weeks’ totals of about half that. Most this week’s cases are in Pennsylvania, though Ohio also saw a substantial increase. 
    • “The CDC noted 38 outbreaks, the same as last week. Last year saw 48 measles outbreaks, defined as three or more related cases. Total cases for all of 2025 reached 2,289, which was the most since 1991 until the country surpassed that level several weeks ago. 
    • “All but 16 of this year’s cases have been locally acquired, with the rest tied to international travel.
    • “Of the 2026 cases, 19% involve children age 5 and under, and 67% involve kids and teens. Seven percent of patients have been hospitalized, compared with 11% in 2025. Among all measles patients, 93% are unvaccinated or have unknown vaccine status.”
  • and
    • “A pair of new studies confirm that recently developed immunizations against respiratory syncytial virus (RSV) protect infants in their first year of life. 
    • “The research, including one study conducted in France and another in the United Kingdom, confirm that the immunizations are effective in the real world, not just in carefully supervised clinical trials”
  • MedPage Today relates,
    • “By this time of year, both the FDA and CDC normally have weighed in on fall respiratory virus vaccine recommendations. But given ongoing controversies over vaccination spurred by the Trump administration, a wrench has once again been thrown into the gears of that process.
    • “The FDA has done its part, making recommendations about vaccine composition for influenza vaccines in March, followed by recommendations for COVID shots in May. But the CDC’s Advisory Committee on Immunization Practices (ACIP) hasn’t done its part as it hasn’t held its March or June meetings this year.” * * *
    • But clinicians shouldn’t worry, because medical groups have stepped in to fill the gaps. The IDSA, the American Academy of Pediatrics (AAP), the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians (AAFP) have issued guidance on fall respiratory virus shots and more, as the Trump administration has also tried to make significant changes to the pediatric immunization schedule.
    • At the same time, insurers have pledged to cover all recommended vaccines without cost-sharing through the end of 2027, Richard Hughes IV, MPH, legal counsel for AAP, said in an email in June.
    • “There are some shades of gray, however, as the FDA approved the first mRNA flu shot (mFlusiva) from Moderna earlier this month. While the company has said its shot — approved for adults 50 and up — should be available for the upcoming 2026-2027 season, it’s unclear whether it will be written into recommendations.”
  • and
    • “GLP-1 agonists and bariatric surgery are top obesity treatments, raising questions of their combined efficacy.
    • “A retrospective study found that patients taking GLP-1 drugs before surgery achieved similar 12-month weight loss as non-users (24% vs 25%).
    • “Treatment groups had comparable outcomes on surgical complications and diabetes control.”
  • Health Exec informs us,
    • “Right now U.S. healthcare has almost everything it needs to eliminate one awful affliction—and then to adapt the resulting victory for going after many others.  
    • “All it would take to set the precedent is responsible AI deployment, attuned government leadership, cross-sector partnerships and generational investments.  
    • “That, and an orchestrated targeting of the low-hanging fruit at hand—cervical cancer.  
    • “The cure-in-waiting for this maddeningly preventable cancer represents a “breakthrough with a failure to follow through,” physician-researchers explain in an article published Aug. 13 in JAMA.  
    • “Erstwhile Surgeon General Special Advisor Adam Beckman, MD, MBA, and co-author Dave Chokshi, MD, MSc, believe cervical cancer is a prime candidate for first dibs because of its 90%-plus early-stage survival rate on top of the near-perfect efficacy of vaccines for human papillomavirus (HPV), which causes many if not most cervical cancers. 
    • “All that’s lacking is the will to “bridge the stubborn gap between what we know and what we do in public health and healthcare,” the researchers write.”
  • Health Day points out,
    • “Taking the stairs instead of the elevator may do more for your health than you think.
    • “A large study published in the American Journal of Cardiovascular Drugs found people who regularly climbed the stairs were 39% less likely to die from cardiovascular disease. And 24% less likely to die from any cause. Their odds of heart attack, stroke and heart failure were also lower.
    • “Taking the stairs is a practical and often overlooked way to build physical activity into daily life,” said senior author Dr. Vassilios Vassiliou, a professor of cardiac medicine at Norwich Medical School at the University of East Anglia in the U.K. “We wanted to better understand how this everyday activity could have life-saving potential.”
  • and
    • “Gambling is a powerful temptation for today’s college students, and those hooked have a greater risk of deeper mental health issues, a new study says.
    • “Student gambling frequently occurs alongside depression, anxiety and substance use, researchers reported recently in the International Journal of Mental Health and Addiction.
    • “What’s interesting about this study is even though mental health concerns were very prominent, students who tended to gamble more were more likely to be experiencing greater levels of problems among a sample that was already experiencing plenty,” said lead researcher Nicholas McAfee, director of the William Magee Center for AOD and Wellness Education at the University of Mississippi.
    • “Gambling is a real concern for college students, given the proliferation of online betting and prediction markets in the United States, researchers said in background notes.”

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

  • The International Foundation of Employee Benefit Plans reports,
    • “U.S. employers project a median health care cost increase of 10% for 2027, according to Health Care Costs Pulse Survey: 2027 Cost Trend, a new survey from the International Foundation of Employee Benefit Plans. A similar International Foundation survey conducted in 2025 also projected a 10% increase for 2026.” 
  • Healthcare Dive adds,
    • “Nearly 4 in 5 U.S. adults said either high insurance premiums or out-of-pocket spending were the most important problem in the healthcare system, according to a Commonwealth Fund survey released Thursday. 
    • “Affordability concerns crossed party and coverage lines. Premiums were the top problem for 45% of Republicans, 44% of Democrats and 42% of independents, while more than 8 in 10 adults with employer, individual or marketplace coverage — as well as uninsured adults — said either premiums or out-of-pocket costs were the biggest issue.
    • “Still, according to the survey, Americans are split over who’s best to tackle the problem. Most respondents said the federal government is best suited to solve high healthcare prices, while Republicans were more likely to say insurance companies were best to address the issue.”
  • FEHBlog observation — Consumers pay insurance premiums and cost sharing but evidently fail to understand that those costs are driven by hospital, doctors and pharmacy charges.
  • In that regards, The Washington Post relates,
    • Prescription drug prices recorded the biggest year-over-year drop in more than 60 years in July, a startling reduction experts chalked up to an array of factors, including more generics and discount GLP-1 weight-loss drugs. 
    • While overall costs for medical services continued to rise, prices for medicinal drugs fell 2.7 percent over the 12 months ending in July, the largest annual drop on record, according to Bureau of Labor Statistics data released Wednesday. Prescription drugs, part of the medicinal drug category, fell by 3.1 percent, the steepest annual decline since March 1963.
  • EBRI calls to our attention,
    • “Plan sponsors that wish to introduce or continue offering health savings account (HSA)-eligible health plans as part of their workplace benefit program can benefit from a long-term view of HSA accountholder behaviors. As such, the Employee Benefit Research Institute (EBRI) has undertaken a series of longitudinal studies from its HSA Database, examining trends in account balances, individual and employer contributions, distributions, invested assets, and account-owner characteristics from 2011‒2024. Such analysis can help plan sponsors, providers, and policymakers better understand strategies that can help improve employee financial wellness.”
    • “HSAs offer a triple tax advantage to accountholders, enabling them to stretch money they save for health care expenses further than they otherwise could. The tax benefits of HSAs are maximized when accountholders contribute the statutory maximum and minimize withdrawals for current medical expenditures — if they are able — and invest their HSA balances in assets other than cash. However, the majority of accountholders appear to use their HSAs to pay for current expenses and do not take complete advantage of the tax benefits HSAs offer. Average contributions are well below the statutory maximum, most accountholders take a distribution from their HSA, and relatively few accountholders invest. We do find that as time goes on, accountholders tend to take fuller advantage of the benefits HSAs offer. And, despite out-of-pocket spending on health care rising by 5.9 percent in 2024, average balances in HSAs increased, rising from $4,747 in the prior year to $5,532. Further, the share of accountholders who invest their HSAs has crept steadily upward since EBRI began analyzing its HSA Database, reaching 18 percent in 2024.”
  • Beckers Hospital Review tells us,
    • “Providence Health Plan will completely shut down after it was unable to reach a deal with a national insurer to operate its Medicare Advantage business.
    • “We are in discussion with regulators about this development and the broader wind-down of Providence’s health plan operations,” a spokesperson for the system told Becker’s. “We will share more details with our members and the public as we are able under applicable regulations.”
    • “In May, the Renton, Wash.-based health system said it would shutter most of its insurance business beginning in 2027 after operating more than 40 years as a regional payer and serving more than 440,000 members. 
    • “At the time, President and CEO Erik Wexler said state and federal regulations and consolidation among large insurers had left Providence “in an untenable situation” and unable to continue operating the health plan.”
  • and
    • “Cleveland Clinic recorded operating income of $245.6 million (5% operating margin) during the second quarter of 2026, down from operating income of $255.3 million (5.6% margin) during the same period last year, according to its Aug. 14 financial report.”
  • and
    • “New Orleans-based Ochsner Health recorded operating income of $32.5 million (0.8% operating margin) in the first half of 2026, up from an operating loss of $42.7 million (-1.1% margin) during the same period last year, according to its Aug. 13 financial report.” 
  • Beckers Physician Leadership points out,
    • “Hollywood, Fla.-based DermCare Management and Dallas-based U.S. Dermatology Partners have partnered to form one of the largest dermatology groups in the U.S. 
    • “The combined company will expand patient access, preserve physician autonomy, support national dermatology clinical trials, improve practice management support and unify culture, according to an Aug. 13 news release from DermCare Management. 
    • “DermCare Management partners with more than 270 dermatology practices, and U.S. Dermatology Partners supports a network of more than 120 locations across nine states.” 

Tuesday report

David Ermer–CDC, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The Washington Post reports about the President’s August 10, 2026, executive order on child vaccinations.
    • “Insurers probably would still cover childhood vaccines even if Trump administration officials change the schedule. 
    • “If this EO were to withstand legal scrutiny, it appears insurers should still cover recommended vaccines for free,” Jennifer Kates, a senior vice president at KFF, a health policy research and news organization, wrote in an email. She added that spacing the shots over multiple visits is already an option for parents. 
    • “Major insurers have also previously indicated they would continue to cover vaccines even in the face of potential changes. White House officials told reporters on Monday that they believed health insurers would continue to cover vaccines currently on the childhood immunization schedule regardless of whether recommendations change.”
  • STAT News relates,
    • “As of July 1, eligible Medicare beneficiaries may obtain these medications for a sharply discounted out-of-pocket cost of $50 per month. That is the headline many patients will hear and remember.
    • “What follows, however, is far more complicated. Eligibility depends on a detailed checklist of body mass index thresholds, specific combinations of chronic conditions, and prior treatment histories. Many patients will not absorb these details, and many clinics will need time and effort to interpret them.” * * *
    • “As a result, the administrative workload associated with GLP‑1 prescribing often rivals the clinical work itself, stretching already limited primary care resources and diverting attention from other critical aspects of chronic disease management.
    • “Each step introduces friction — points where patients may be delayed, confused, or lost in the process entirely. Programs that are difficult to navigate tend to benefit those with time, health literacy, and persistent advocacy while leaving behind those who are already at risk of poorer outcomes. A benefit that exists on paper is altogether different from access in practice.
    • “For clinicians, the burden is also real. Primary care is already stretched thin, managing rising patient complexity alongside mounting administrative demands. Many practices will absorb this new Bridge workload, driven, as always, by a commitment to their patients. But that commitment is not an unlimited resource. Each additional administrative layer adds to the strain on a specialty already facing workforce shortages, burnout, and declining morale.
    • “Faced with these demands, some private practices may decide that participation in the Bridge program is simply not sustainable.” 
  • MedTech Dive tells us,
    • “Orthopedics firms are shrugging off worries that a new, mandatory Medicare joint replacement model could drive down implant payments.
    • “The Centers for Medicare and Medicaid Services finalized the Comprehensive Care for Joint Replacement Expanded Model, called CJR-X, as part of its hospital inpatient payments rule at the end of July. CJR-X would go into effect in 2028, making hospitals responsible for more spending on joint replacement surgery and associated costs, including the hospital stay and follow-up care provided in the first 90 days of recovery. Hospitals may be eligible for an additional payment from Medicare, or may be required to repay a portion of a patient’s care, depending on quality and spending. Regulators expect the model to save the government $725 million over five years.”

From the Food and Drug Administration front,

  • Reuters reports,
    • “The U.S. Food and Drug Administration on Tuesday finalized guidance for preparation and ‌packaging of fresh-cut produce, recommending measures such as sanitation control, supplier verification and refrigeration to reduce the risk of foodborne illnesses.
    • “The guidance for ready-to-eat produce comes as ongoing outbreaks of cyclosporiasis and salmonella due to contaminated lettuce and jalapenos ​have sickened thousands of people in the United States.”
  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has finalized a new recall related to an issue with certain Johnson & Johnson MedTech introducer sheaths. 
    • “These devices are used to introduce Impella heart pumps to the bodies of patients. Johnson & Johnson MedTech and Oscor, the company’s manufacturing partner, received multiple reports of the sheaths leaking in ways that could result in access-site bleeding. 
    • “If leakage does occur, it would come from the device’s sidearm or under the sheath cap. This issue has only been seen with specific lots of 14 and 23 French introducer kits compatible with the Impella RP Flex with SmartAssist, Impella RP Set with SmartAssist, Impella 5.5 Set with SmartAssist, and Impella CP Set.”
  • and
    • “Bracco Imaging has secured U.S. Food and Drug Administration (FDA) clearance for VueJect, a new ultrasound contrast delivery system built specifically for cardiovascular imaging procedures. This represents the latest addition to Bracco’s contrast-enhanced ultrasound (CEUS) portfolio. 
    • “According to Bracco, VueJect was designed to improve workflow efficiency, provide consistency from one operator to the next and enable the continuous administration of ultrasound contrast agents such as Bracco’s Lumason.” 

From the judicial front,

  • The International Foundation of Employee Benefit Plans notes,
    • “The Federal Trade Commission’s settlements with Caremark Rx and Express Scripts could reshape how pharmacy benefit managers present pricing options to plan sponsors. While the PBMs denied allegations that they inflated insulin costs, the settlement orders require new standard offerings designed to increase transparency, limit member out-of-pocket costs and give plan sponsors clearer alternatives to rebate-driven pricing.
    • “A previous blog covered the FTC orders requiring Caremark Rx and Express Scripts to stop favoring high-list-price versions of drugs over identical low-list-price versions on their standard formularies. This post looks at the settlement terms most relevant to plan sponsors and members.”

From the public health and medical / Rx research front

  • The Washington Post reports,
    • “About 30,000 pounds of Argentine beef has been recalled by the U.S. Agriculture Department because it wasn’t inspected before entering the country. 
    • “The different cuts of raw beef from the company Corte Argentino USA were shipped to retailers and grocery distributors in Florida and Texas. The meat was produced from May 15 to May 20 and had freeze-by dates of Sept. 15-20. 
    • “The recalled meat included cuts of top sirloin and eye round.
    • “The Agriculture Department’s Food and Safety Inspection Service checks imported products for packaging, documentation, condition and contamination. The agency said no confirmed cases of illness have been linked to the products. 
    • “Consumers are advised not to eat the meat, and either discard it or return it for a refund.”
  • MedPage Today relates,
    • “The CDC on Tuesday warned doctors about the risk for severe arboviral neuroinvasive diseaseopens in a new tab or window in patients on B cell-depleting or modulating agents, calling out anti-CD20 monoclonal antibodies in particular.
    • “Published case reports indicate an overall mortality of about 40% for patients on anti-CD20 antibodies with arboviral neuroinvasive disease, and neurologic sequelae were common in survivors. The most common virus involved in the reports was West Nile, but severe cases also involved eastern equine encephalitis, Powassano, La Crosse, and others.
    • “In recent years, a novel clinical presentation of chronic, neurodegenerative encephalitis developing over months to years has been described in at least five patients receiving rituximab who were infected with an orthobunyavirus, including Jamestown Canyon virus, Cache Valley virus, or Potosi virus,” the CDC said in a Health Alert Network advisory.”
  • and
    • “Guidelines recommend individualizing HbA1c goals to health status in older adults with type 2 diabetes.
    • “A review of electronic health records found that most older adults with type 2 diabetes outside target HbA1c goals didn’t receive medication adjustments in the right direction.
    • “Only 17% of below-goal patients had their regimen deintensified, while 33% of above-goal patients had their treatment intensified.”
  • Beckers Hospital Review tells us,
    • “Researchers at Baltimore-based University of Maryland School of Medicine found approximately 5% of adults hospitalized with firearm injuries develop a bacterial infection, with most infections occurring during hospitalization.
    • “The study, published Aug. 3 in JAMA Network Open, used the Premier Healthcare Database to analyze 24,024 adults hospitalized with firearm injuries at 323 hospitals between January 2019 and May 2021. Bacterial infection was defined by positive culture results from any source and antibiotics initiated within 2 days of those results that were continued for at least four days or until discharge.”
  • Healio adds,
    • “Percentages of adolescents who engaged in suicidal thoughts and behavior fell from 2021 to 2025, according to the 2025 National Survey on Drug Use and Health.
    • “These are encouraging trends,” Brandon Johnson, MHS, MCHES, chief, suicide prevention branch, Substance Abuse and Mental Health.”
  • Cardiovascular Business informs us,
    • “Abdominal fat is a more accurate predictor of heart disease than body mass index (BMI) alone, according to new findings published in JACC.[1]
    • “BMI remains the most common way that clinicians determine if an individual is overweight or obese. The team behind this new analysis hoped to learn if taking waist circumference (WC) and waist-to-hip ratio (WHR) into account could lead to better assessments of a person’s risk of developing cardiovascular disease (CVD). 
    • “The study included data from more than 260,000 adults over the age of 20 years old. The median follow-up period was 20 years. 
    • “Among patients with a normal weight as determined bv BMI, 5% had a high WC and 18% had a higher WHR. Among overweight patients, 39% had a high WC and 40% had a high WHR. Finally, among obese patients, 9% had a low WC and 45% had a low WHR.”
  • The New York Times points out “The Best Healthy Eating Advice of 2026 (So Far).”
    • “Frozen yogurt is not exactly a health food.”
    • “Your diet influences your cancer risk.”
    • “Be wary of ‘low-carb’ diets.”
    • “The science of intermittent fasting isn’t as sound as you may think.”
    • “Oats are powerhouses of nutrition.”
    • “There is such a thing as too much protein.”
    • “You should probably try to get more fiber.”
    • “The dangers of alcohol start at one drink per day.”
    • “Don’t pass on peas.”
    • “Sipping warm water before breakfast has benefits, but is not a cure-all.”
  • The latest NIH Research Matters post covers the following topics,
    • Childhood screen detects mental health risks
      • Screening for home and family stresses may help identify children at risk for depression and sleep disorders that traditional adversity screening misses.
      • This type of screening could be used to identify and intervene with children at risk of mental health conditions.
    • Immune cells cross blood-brain barrier during human aging
      • “Researchers found that some of the brain’s immune cells are replaced by immune cells from bone marrow as people age.
      • “The findings suggest that scientists might one day be able to use immune cells born outside the brain to deliver therapies for brain disorders.”
    • Improving Parkinson’s disease treatment
      • “Researchers identified a drug candidate that enhanced effectiveness and reduced side effects of the standard Parkinson’s disease treatment in animal models.
      • “If the drug candidate proves effective in people, it could be an effective way to improve treatment for Parkinson’s disease.”
  • Health Day points out,
    • “Heart health appears to affect brain health among people with a genetic risk for Alzheimer’s disease, a new study says. 
    • “People whose hearts are pumping blood less effectively tend to have brains that are shrinking faster, researchers recently reported in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association.
    • “This is true among people who carry APOE-ε4, a genetic variant that is known to increase risk of Alzheimer’s, researchers said.
    • “Our findings suggest that even subtle reductions in cardiac function may have important implications for brain health, particularly among individuals at increased genetic risk for Alzheimer’s disease,” lead researcher Dr. Elizabeth Moore said in a news release. She’s a clinical fellow in neurology at Mass General Brigham in Boston.”
  • and
    • “If you have atrial fibrillation, or A-fib, getting moving may make a real difference.
    • “A-fib is an irregular heartbeat that raises the risk of stroke — and it affects an estimated 10.5 million adults in the U.S. Yet research shows that people with A-fib tend to be less active than the general population.
    • “A new study of more than 87,000 adults found that even a little physical activity was tied to better odds of avoiding stroke and death — and the benefits held up whether or not participants had A-fib.”
  • The New York Times lets us know,
    • “A.I. Is Finding Sperm Where Doctors Couldn’t
    • “New technology may make it easier for men with extremely low sperm counts to have biological children.”

From the U.S. healthcare business front

  • Beckers Hospital Review reports,
    • “Kaiser Permanente has committed up to $32 million to support the expansion of the Hope Emergency Center at Martin Luther King Jr. Community Hospital in Los Angeles.
    • “The commitment includes a $25 million charitable grant, the largest gift in the hospital’s history, along with the purchase and loan of a $7 million modular building to keep emergency care running during construction, according to an Aug. 11 news release. The funding will also support long-term improvements to emergency services in South Los Angeles.”
  • and
    • “Nonprofit systems expand into Pennsylvania as for-profits exit.” * * *
    • “The expansion of large nonprofit systems into Pennsylvania might suggest the state has become more attractive, but worsening conditions are leaving smaller hospitals with fewer options.
    • “I’d actually say it’s less attractive to expand [into Pennsylvania] than in the past,” Ben Gerber, CEO of Peak Health and senior vice president and chief strategy officer of WVU Medicine, told Becker’s. “But the hospitals there are running out of options, and they can’t survive on their own. They need partners with broader scale and capability.
    • “It’s not that it’s become more attractive for us; it’s that it’s become impossible for smaller health systems to continue standing, and someone’s got to step in.” 
  • Beckers Behavioral Health relates,
    • “Smithfield, N.C.-based Johnston Health has the lowest median emergency department visit time for psychiatric and mental health patients.
    • “Becker’s has compiled lists of hospitals and health systems with the shortest and longest emergency department visit times for psychiatric and mental health patients using CMS’ Timely and Effective Care-Hospital data. 
    • “The CDC tracks the median length of stay for ED patients as part of its “timely and effective care” measure set. The data was released May 13 and covers ED visits recorded from July 2024 through June 2025. Measures in this dataset apply to all adults and children treated in hospitals paid under either the inpatient or outpatient prospective payment systems. Learn more about the measures here.
    • “Most hospitals on the list of the shortest visit times are small community or critical access hospitals that may see lower annual ED volumes and patient acuities than facilities operating level 1 or 2 trauma centers. CMS does not include hospitals’ total ED volumes or case mix index in its dataset. To effectively assess ED performance, experts recommend benchmarking against a cohort of similar facilities.
    • [The article identifies] 20 hospitals and health systems with the shortest and longest median ED visit times before leaving the visit, along with the sample size.
  • Fierce Healthcare lets us know,
    • “Health insurers are under significant financial pressure, and the gap between the organizations that are adapting and those that are not is growing, according to a new report.
    • “HealthScape Advisors, an organization under Chartis, released its annual look at health plans’ financial performance and found that the number of plans posting an operating loss has increased over the past several years. In 2023, 54% of health plans reported an operating loss, and that grew to 70% in 2024.
    • “The number of insurers with an operating loss then rose a second time to 73% in 2025, according to the report.
    • “Operating losses are concentrated among regional plans and Blues plans, with 72% of regional insurers and 83% of Blues reporting one in 2025.”
  • MedTech Dive tells us,
    • “Teledyne Technologies said Monday it has agreed to buy Varex Imaging for about $1.1 billion. 
    • “Varex designs, manufactures and sells X-ray imaging components and other products for use in medical and industrial applications. 
    • “Teledyne provides digital imaging technologies for industrial, government and medical use but has minimal overlap between its portfolio and Varex’s products.”
  • Drug Channels blog informs us,
    • “The United States has almost 8,000 fewer retail pharmacies than it did in 2018, and more than 2,000 closed in 2025 alone. Rite Aid has liquidated. Walgreens is working through a multi-year plan to shutter hundreds of stores. CVS has trimmed hundreds more.
    • “Yet total U.S. prescription dispensing revenues for all dispensing formats reached a record $751 billion in 2025, up 10% from 2024.
    • “Record closures and record revenue in the same year may seem contradictory, but national totals obscure very different effects on the community. The impact of the retail pharmacy shakeout on patient access has become geographically K-shaped: dense markets can absorb pharmacy closures with little loss of patient access, while rural communities can lose their only nearby pharmacy.
    • “The economic pressures on pharmacies are similar across the country. The access consequences of a closure are not. [In the article,] we examine what is driving the shakeout and why geography determines which communities can absorb them.

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.”

Thursday report

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

Simplicity is a virtue.

From of a Washington, DC

  • The New York Times reports,
    • “The White House’s push to delay a ban on intoxicating hemp products that President Trump signed into law last year has snarled an otherwise straightforward effort to pass legislation that would lock in government funding through the fall before senators leave Washington on a summer recess.
    • “In an unusual display of defiance, a group of Republicans led by Senator Ted Budd of North Carolina was vowing to kill the hemp proposal that Senate leaders had tucked into the spending bill at the request of Mr. Trump.
    • “The measure would postpone the date the ban will go into effect, from November to Dec. 11.”
  • Beckers Hospital Review relates,
    • “Sens. Maggie Hassan, D-N.H., and Roger Marshall, R-Kan., introduced the Stop Superbugs Act on Aug. 4 alongside a Joint Economic Committee-Minority report estimating antimicrobial resistance costs the U.S. healthcare system at least $5.7 billion annually.”
  • Beckers Behavior Health adds,
    • Federal lawmakers have introduced or revived several bills this year [discussed in the article] aimed at expanding access to addiction and mental health treatment, from new Medicare coverage for residential opioid treatment to permanent funding for community behavioral health clinics.
  • The current president of the Infectious Diseases Society of America, Ronald Nahass, suggests in STAT News that “The U.S. needs a 9/11 Commission-style independent body to investigate Covid response.” The FEHBlog heartily agrees.
  • Beckers Payer Issues tells us,
    • “This fall, CMS will start sharing monthly utilization reports with Part D plans on how their enrollees are using the Medicare GLP-1 Bridge program.
    • “The agency said in an Aug. 5 memo that the reports will be organized at both the contract and plan level and will include claims-level data such as the date of service, drug dispensed, quantity, days supply, prescriber, fill number and beneficiary identifier. All Part D plans will be covered, except for PACE organizations, cost plans and private fee-for-service plans.
    • “CMS uses a central processor to handle prior authorization, claims adjudication and pharmacy reimbursement, meaning Part D sponsors don’t carry risk for GLP-1 drugs furnished through the demonstration. The utilization reports would give insurers a window into how their own members are using the program despite having no direct role in administering it.”
  • The Wall Street Journal adds,
    • “Amazon AMZN .com said patients with Medicare Part D prescription plans now have access to certain GLP-1 weight-loss medications through Amazon Pharmacy.
    • “Oral and injectable versions of Novo Nordisk’s NOVO.B  Wegovy and Eli Lilly’s LLY  Zepbound KwikPen and Foundayo pills will be available and cost $50 a month with free home delivery, Amazon said. It’s offering same-day delivery in more than 3,100 U.S. locations, and no Prime membership is required, the company added.
    • “The medications are available through the Medicare GLP-1 Bridge Program, a short-term federal initiative running through Dec. 31, 2027, that allows eligible Medicare Part D members who meet specific clinical criteria to access weight management prescriptions.” * * *
    • “Amazon Pharmacy manages the entire process, including verifying eligibility, handling prior authorizations, and initiating enrollment, once a clinician submits an electronic GLP-1 prescription, the company said. Customers need to link their Medicare information and Bridge insuranceplan to their account.
    • “Once a patient’s clinician sends the prescription, we take care of the rest and deliver their medication to their door,” said Tanvi Patel, vice president and general manager of Amazon Pharmacy.”

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

  • Govexec reports,
    • “President Trump is expected sometime this month to issue a plan to freeze federal employee pay in 2027, though if last year was any indication, it may not be that straightforward.
    • “When the White House published its fiscal 2027 budget proposal in April, the document, which normally lays out the administration’s pay plan for the following year, was silent on civilian compensation. The Office of Management and Budget later confirmed that Trump was in fact proposing “no pay increase” for 2027, while military service members would see between a 5% and 7% raise, depending upon their rank.
    • “Trump now has until the end of August to formalize his alternative pay plan for next year; otherwise, much larger automatic increases in locality pay would take effect, due to a formula in the 1990 Federal Pay Comparability Act that has been criticized by presidents of both parties since its enactment.”
  • Federal News Network explains how “OPM is preparing to take over federal employee appeals” as the FEHBlog has noted.
    • “OPM outlined significant changes in the new appeal adjudication process, including the loss of federal employees’ “categorical right” to a hearing.” 
  • Fed Agent informs us,
    • “Federal employees who file claims for back pay, unpaid overtime, unused leave, and other compensation issues will soon be required to submit them through the Office of Personnel Management’s (OPM) eFile system rather than by mail or email. 
    • “The changes could be especially relevant for law enforcement officers and other federal employees who file Fair Labor Standards Act (FLSA) overtime claims.
    • “In an updated rule for Procedures on Settling Claims, OPM said switching to an eFile system “will be used for all appeals and claims to allow for faster receipt facilitating OPM’s processing and review.”
    • “The new system will apply to a wide range of submissions, including claims filed by current and former federal employees, as well as claims submitted by beneficiaries of deceased federal employees and deceased veterans.”

From the FDA front,

  • The Wall Street Journal reports,
    • “Replimune Group said Thursday that the Food and Drug Administration has approved its therapy for advanced skin cancer, ending a regulatory saga that spanned three submissions and two rejections and was a flashpoint in the tenure of the agency’s last commissioner.
    • “Replimune’s drug, marketed as Tudriqev, is a genetically modified virus that doctors inject directly into tumors, where it is designed to kill cancer cells and trigger an immune response against tumors elsewhere in the body.
    • “The drug’s arduous journey through the FDA made it a poster child for the biotech industry’s criticism of the agency under former Commissioner Marty Makary. Replimune and other industry officials said the FDA, in its rejections, had reversed positions it had established in earlier meetings with the company.”
  • Targeted Oncology relates,
    • “The FDA granted accelerated approval to RP1 (vusolimogene oderparepvec; Tudriqev), an oncolytic virus therapy, in combination with nivolumab (Opdivo), for the treatment of advanced melanoma following progression on an anti–PD-1–containing regimen.
    • “The decision follows a July 30, 2026, meeting of the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC), which voted 10-3 in favor of the potential accelerated approval based on data from the phase 2 IGNYTE trial (NCT03767348). Despite the FDA raising concerns over the study design and clinical meaningfulness of the trial data, the committee supported the accelerated approval because of the unmet need in this setting, with the confirmatory IGNYTE-3 trial (NCT06264180) already underway to support regular approval.”

No Surprises Act News,

  • FHAS, a certifed independent dispute resolution entity, offers helpful guidance about implementing the NSA RARC codes in out-of-network electronic and paper claims.

From the judicial front,

  • Beckers Physician Leadership reports,
    • “A physician in Texas was sentenced to 12.5 years in prison for operating a medical clinic as an illegal pill mill. 
    • “Maryam Qayum, MD, owned, operated and was the sole prescriber at Recare Health Clinic in Houston. The clinic was operated as a cash-only pill mill, and Dr. Qayum issued prescriptions without a legitimate medical purpose, according to an Aug. 5 news release from the Justice Department. 
    • ‘Between 2022 and 2025, Dr. Qayum issued more than 3 million prescriptions for opioids including oxycodone and hydrocodone. Law enforcement shut down the clinic in 2025.”
  • Beckers Health IT relates,
    • “Health systems, insurers and AI companies are facing a wave of litigation in 2026 over how artificial intelligence is used to make or influence decisions about patient care, coverage and billing.”
    • The article discusses three such cases. 

From the public health and medical / Rx research front,

  • Health Exec identifies “Current and potential outbreaks to be aware of—and ready to talk about.”
  • Cardiology Business adds,
    • “The American College of Cardiology (ACC) has shared a new concise clinical guidance (CCG) detailing specific vaccine recommendations for adults and children with a history of cardiovascular disease (CVD).[1] The group reviewed its own evidence-based guidelines as well as updated resources developed by the American College of Physicians and U.S. Centers for Disease Control and Prevention. 
    • “Patients with heart disease face a higher risk of adverse outcomes, including hospitalization and death, following respiratory virus infection compared with the general population,” wrote first author Paul A. Heidenreich, MD, a cardiologist with Stanford University and chair of the CCG’s writing committee, and colleagues. “Additionally, the likelihood of infection after exposure may be elevated in this population.”
    • “Heidenreich et al. also emphasized that both randomized clinical trials and observational studies have consistently demonstrated the advantages of vaccination. Adverse side effects, the group added, are “exceedingly rare and are far outweighed by the demonstrated benefits.”  
  • MedPage Today notes,
    • “The U.S. Preventive Services Task Force recommends annual fecal immunochemical test screening starting at age 45 among average-risk adults to reduce the risk of death from colorectal cancer.
    • “In a retrospective population-based cohort study from Spain, fecal immunochemical test-based screening was linked to an ongoing decline in colorectal cancer mortality.
    • “Counterfactual analyses suggested a 41.7% relative reduction in mortality overall, a 46.2% relative reduction in those ages 50 to 69, and a 45.4% relative reduction in those ages 70 and older compared with projected trends without screening.”
  • The American Medical Association lets us know what doctors want their patients to know about hand, foot, and mouth disease.
  • The Washington Post reports,
    • “Hundreds of people in 27 states have been sickened in a salmonella outbreak linked to jalapeño peppers, including at Chipotle and Qdoba restaurants, the Centers for Disease Control and Prevention said.
    • “As of Tuesday, 345 cases had been reported with 36 people hospitalized, the agency said Wednesday. The cases, which date back to June 19, are expected to rise and expand to more states. 
    • “Twenty-seven “illness clusters” have been identified at Chipotle and Qdoba locations in seven states, the agency said, after health officials found that most of those who got sick reported eating in a Mexican-style restaurant. * * *
    • Neither restaurant is considered an ongoing risk, the CDC said. The distributor is recalling the affected peppers, and other businesses are being urged to check their stocks for recalled jalapeños and not sell or serve them, it said.
    • Salmonella bacteria, the most frequently reported cause of foodborne illness, can cause diarrhea, vomiting, fever and stomach pain.
  • Beckers Hospital Review relates,
    • “The CDC is tracking clinical cases of Candida auris in more than half of U.S. states this year, though the total number of infections from the deadly fungus is down from this time in 2025.
    • “The agency has recorded 3,302 clinical cases of Candida auris across 27 states through the week ending July 18, according to National Notifiable Diseases Surveillance System data. That’s down from 4,102 clinical cases reported over the same period in 2025.
    • “A separate CDC screening count, which tracks colonization detected before any illness develops, logged 3,130 cases across 23 states over the same period, essentially flat compared with 3,348 a year earlier.
    • ‘California leads all states in clinical cases with 826, followed by Texas with 391 and Ohio and Tennessee tied at 274 each. The screening count tells a different geographic story: Texas leads with 706 screening cases, followed by Michigan (503) and Illinois (366).”
  • Beckers Clinical Leadership adds,
    • “The Virginia Department of Health said Aug. 4 it has identified the state’s first locally acquired case of dengue.
    • “The patient lives in the Fairfax and Loudoun county area and had not traveled outside Virginia before falling ill.
    • “State officials traced the infection to an earlier traveler who had contracted dengue abroad. A local Aedes mosquito bit that infectious patient, then transmitted the virus to the second resident. The health department said it has found no evidence of continued local spread.
    • “The department called the overall risk of acquiring dengue in Virginia low.”
  • MedPage Today tells us,
    • “Anxiety and depression have been extensively studied in patients with inflammatory bowel disease (IBD), but research has rarely investigated the pre-diagnostic period.
    • “In a Swedish cohort study, the relative rate of any psychiatric disorder started to increase 2-3 years before IBD diagnosis, peaked soon after diagnosis, and rapidly decreased post diagnosis, but remained elevated at 10 years.
    • “This increased risk was mainly driven by major depressive disorders, anxiety disorders, and substance misuse.”
  • STAT News informs us,
    • “In the race for new ways to treat Alzheimer’s and other devastating neurologic diseases, the protein tau has become a tantalizing target for drug developers. A new study lends support to those efforts by describing a previously unknown role that tau plays in neurodegeneration — and suggesting a novel way researchers might block the protein’s activity.
    • “A team led by Stanford scientists found that tau can gum up the works of a cell’s mitochondria, its energy-producing powerhouse. The protein sends electrons flowing in the opposite direction of their usual microscopic relay race, a reversal that generates reactive oxygen species, cellular stress, and inflammation. Scientists found that blocking this phenomenon, known as reverse electron transport, reversed many of the harmful effects and improved learning and memory in flies and mice.
    • “Whether the same will hold true in people is for now unclear, though an analysis of human cells grown in the lab and patient brain tissue suggests blocking the retrograde flow of electrons could make neurons healthier. Two of the study’s authors have started a biotech startup to put this idea to the test. 
    • “The findings, published on Thursday in the journal Neuron, have implications for a range of so-called tauopathies, diseases marked by an abnormal buildup of tau, such as Alzheimer’s, Huntington’s, and frontotemporal dementia.”
  • Genetic Engineering and Biotechnology News points out,
    • Chronically infecting viruses—such as Epstein Barr, cytomegalovirus, and herpes virus—are ubiquitous in humans. Although their presence is often innocuous and asymptomatic, the viruses can reactivate during stress, and emerging evidence suggests that their reactivation may contribute to autoimmune disease and other chronic conditions. SARS-CoV-2 infection is known to reactivate some chronic viruses, yet the full extent of the effects is not well understood.
    • Now, a study including 15 biomedical research institutions across the United States, Boston Children’s Hospital researchers and their collaborators have discovered that COVID-19 reactivates certain dormant viruses in hospitalized patients. These findings expand understanding of chronically infecting viruses and could inform development of strategies to combat their reactivation.
    • “This work is published in a new study in Nature, entitled, “Virus reactivation in acute and long COVID-19.”
  • The New York Times notes,
    • “Novo Nordisk stunned the cardiology world last week when it announced that a large study it was running on an experimental drug for heart disease had failed. The drug, widely expected to be a blockbuster, was no better than a placebo.
    • “The drug, ziltivekimab, reduces inflammation, which is generally thought to be a cause of atherosclerosis. Stopping that inflammation was hoped to be a way to save lives.
    • “Now the drug’s failure is raising a troubling question. Is inflammation really a cause or is it just a marker of atherosclerosis, the way gray hair is a marker of aging?
    • “Cardiologists had mixed reactions to the news. Dr. Sanjay Kaul, a cardiologist at Cedars Sinai, quoted Thomas Huxley on X: “The great tragedy of science — the slaying of a beautiful hypothesis by an ugly fact.”

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

  • Health Exec points out,
    • “The latest lineup of America’s “best of the best” hospitals from US News & World Report is something of an embarrassment of riches for a few cities and health systems. 
    • “The list—which ranked hospitals numerically until 2023 but now presents 20 institutions alphabetically as an “honor roll”—names one health system three times.
    • “That would be Mayo Clinic, recognized for each of its operations in Rochester, Minn., Phoenix, Ariz., and Jacksonville, Fla. 
    • “Meanwhile New York City is home to three winning institutions—Mount Sinai, NewYork-Presbyterian and NYU Langone. 
    • “A few cities have two hospitals in the roll. These are Boston (Brigham and Women’s, Massachusetts General), Chicago (Northwestern, Rush) and Los Angeles (Cedars-Sinai, UCLA Ronald Reagan).
    • “The state with the most honorees is California, which has bragging rights to five—the two L.A. hospitals named above plus Stanford Health Care in Palo Alto, UC San-Diego Health in that city and UCSF Health in San Francisco.”
  • Beckers Hospital Review adds,
    • “The Emergency Nurses Association awarded a record-breaking 126 emergency departments with the 2026 Lantern Award.
    • “To receive a Lantern Award, EDs must submit a comprehensive application which measures how they excel in meeting challenges, including ED boarding, improving pediatric readiness and enhancing nurse professional development, according to a July 27 news release. ENA Lantern Award Committee reviews and scores applications based on evidence-based practices and innovation in emergency care. Learn more here. The Lantern Awards have been awarded annually since 2011.
    • “Last year, 96 hospitals received a Lantern Award.”
    • The article lists the 2026 awardees by State.
  • Beckers Hospital Review outlines the 23 hospital M&A transactions that have happened this year.
  • Beckers Payer Issues calls attention to “the thread running through payers’ and for-profit [health] systems’ Q2 earnings,” and tells us,
    • “Oscar Health’s membership as of June 30 was 2,963,002, up from 2,027,148 at the same time in 2025.
    • “The company reported net income of $361.8 million for the second quarter of 2026, up from a $228.4 million loss during the same period last year. Revenue was roughly $4.9 billion, up 70.4% year over year. Earnings from operations were $388.6 million versus a prior $230.5 million loss, driven by stronger underwriting performance, along with favorable prior period development.
    • “The insurer logged a medical loss ratio of 79.2% for the quarter, down from 91.1%. 
    • ‘The full-year 2026 outlook for earnings from operations is now $500 million to $700 million, a boost from $250 million to $450 million previously.”
  • BioPharma Dive reports,
    • “LifeMine Therapeutics, a biotechnology company led by serial entrepreneur Greg Verdine, said Thursday it raised $263 million in a pair of venture financings that will push a novel, protective treatment for organ transplants deeper into later clinical testing.
    • “To find that new drug, codenamed “LIFE-001,” LifeMine looked to a billion-year-old place: the fungal genome. It’s the same starting point that led to the first statin, penicillin, and a widely used immunosuppressant called cyclosporine. While these and many other medicines are derived from fungi, LifeMine has for years been working to make the discovery process more systematic and repeatable, amassing a database of genomic information in the hopes of uncovering promising drug prospects. 
  • MedTech Dive interviews “Medtronic’s George Murgatroyd [about] an advanced computing platform that works with the company’s Hugo robot will power AI algorithms that can assist surgeons as they operate.”

  • Beckers Physician Leadership notes,
    • “Aflac’s fourth annual Wellness Matters Survey found 76% of Gen Z and 63% of millennials now turn to artificial intelligence as their first line of primary healthcare, according to results released Aug. 4.
    • “The survey, conducted in March 2026 by Kantar Profiles among 2,000 employed U.S. adults ages 18 to 65, found AI use for healthcare drops sharply with age: 47% of all Americans surveyed use AI for health information, compared to 76% of Gen Z and 63% of millennials.
    • “The shift toward AI comes as younger workers skip in-person care. Sixty-five percent of Gen Z and 61% of millennials reported skipping routine checkups in the past year, compared to 47% of Gen X and 33% of baby boomers. Only 48% of Gen Z respondents have a primary care doctor, versus 87% of baby boomers.
    • “Emergency and urgent care use also rose among Gen Z, climbing to 62% in 2026 from 51% in 2025. Usage increased among Hispanic, Black, and Asian American respondents as well.
    • “Matthew Owenby, Aflac’s chief human resources officer and chief administrative officer, said younger Americans are substituting convenience for consistent care. “Young Americans are replacing in-person preventive care with the convenience and speed of digital health support,” Mr. Owenby said.”

Tuesday report

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

From Washington, DC,

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

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

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

From the Food and Drug Administration front,

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

From the public health and medical/Rx research front,

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

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

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

Monday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NCQA, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • STAT News reports,
    • “Senate leadership on Sunday released the text of a bipartisan government funding stopgap measure that would block the White House’s proposal to give political appointees control over federal research grants. 
    • “The continuing resolution would fund the government until Dec. 11. It would only block the Trump administration’s new grants proposal until that time, but it will be more difficult for Republicans to allow the White House’s plan to take effect now that they’ve agreed to blocking it, even if temporarily.” 
  • Roll Call adds,
    • “Just as Senate GOP leaders plan to begin moving several big-ticket items ahead of a planned August recess, President Donald Trump will head out west for a Los Angeles-area fundraiser and an economic speech in Las Vegas.
    • “Trump is set to return to Washington, D.C., Wednesday night — when the chamber could be a few votes away from a monthlong recess in a midterm election year. And the president’s recent statements, threats and willingness to shift on policy shows he’s capable of slowing things down.” * * *
    • “[Senate Majority Leader John] Thune has teed up an ambitious week as he tries to move several big-ticket measures while also freeing vulnerable GOP senators to get back home to campaign until mid-September. He wants to pass a continuing resolution to fund the government until Dec. 11, including a number of White House-requested priorities the House did not have when it passed its own continuing resolution before leaving for the summer last month.
    • “Also on Thune’s list: a cryptocurrency bill, over 70 executive branch nominations and a Russia sanctions bill largely crafted by the late Sen. Lindsey Graham, a South Carolina Republican and close Trump ally.”
  • and
    • “The Senate is back on track to consider acting Attorney General Todd Blanche’s nomination to lead the Justice Department permanently after two key GOP holdouts said they were “pleased” with a deal they struck. 
    • “The DOJ said in a statement posted Sunday night that it has “rescinded” a $1.8 billion “anti-weaponization” fund meant to compensate people targeted by the federal government. The fund was part of a settlement brokered by Blanche that resolved President Donald Trump’s $10 billion suit against the Internal Revenue Service tied to the release of his tax returns during his first term in office.
    • “It was enough to satisfy Sens. John Cornyn, R-Texas, and Thom Tillis, R-N.C., who expressed “gratitude” in a Monday statement and wrote, “We look forward to voting to advance his nomination out of the Senate Judiciary Committee soon.”
    • “The Judiciary panel is now scheduled to vote on Blanche’s nomination Tuesday morning, after canceling a meeting last week.”
  • Govexec relates,
    • “Federal employees and contractors whose sensitive personal data was stolen in the massive Office of Personnel Management breaches disclosed a decade ago would receive identity protection for the rest of their lives under new bicameral legislation.
    • “Senate Intelligence Committee Vice Chair Mark Warner, D-Va., and Del. Eleanor Holmes Norton, D-D.C., plan to introduce the RECOVER PII Act on Monday, aiming to prevent the federal government’s identity-protection program for victims from expiring Sept. 30, according to bill text first seen by Nextgov/FCW.” * * *
    • “Congress responded to the breach in a 2017 appropriations law by requiring OPM to provide victims with at least 10 years of complimentary identity protection and no less than $5 million in identity-theft insurance. The new bill would replace that limit with coverage lasting for the remainder of each affected person’s life while retaining the insurance requirement.
    • “We have a responsibility to stand by the federal workers who were put at risk through no fault of their own,” Warner said. “This legislation will ensure those affected continue to receive the identity protection they need, while helping better safeguard personal information from future exploitation.”
    • “The bill would also allow agencies to reimburse federal employees and contractors for privacy tools and services, such as those that remove or limit their personal information online. Agencies would decide whether to offer the reimbursements, which would not be limited to OPM breach victims and would come from their salary-and-expense budgets.”
  • Per Health and Human Services news releases,
    • U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today traveled to southwest Virginia as part of his “Take Back Your Health” tour to highlight Trump Administration’s efforts to expand addiction recovery, strengthen American agricultural and food supply chains, and recognize President Trump’s historic $50 billion Rural Health Transformation Fund.
    • “On Monday, Secretary Kennedy joined Congressman John McGuire for visits to Tranquility Grove Rehabilitation Center and the Virginia Tech Controlled Environment Agriculture Innovation Center. Under President Trump’s leadership, combating addiction and mental illness remains a national priority. The Administration is also advancing innovative agricultural technologies that strengthen domestic food production, improve supply chain resilience, and help deliver healthier food to the American people.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) today marked National Health Center Week by announcing that Health Resources and Services Administration (HRSA)-funded health centers served more than 32.7 million patients in 2025 — an increase of more than 350,000 patients from 2024 and the highest number of patients served in the Health Center Program’s 61-year history.”
  • Per a Centers for Medicare and Medicaid Service news release,
    • “The Centers for Medicare & Medicaid Services (CMS) recently hosted the one-year celebration of the Health Technology Ecosystem, bringing together leaders from the government, healthcare, and technology sectors to feature the significant progress made over the past year in advancing interoperability, improving health data sharing, and expanding patient access to digital health tools.
    • “The event featured remarks from U.S. Department of Health and Human Services (HHS) leadership, with speakers reflecting on Health Technology Ecosystem accomplishments during its first year, highlighted industry collaboration, and outlined priorities for the initiative’s next phase.” * * *
    • “The event concluded with a discussion of the next phase of the Health Technology Ecosystem and opportunities to expand industry participation. Leaders also introduced new areas for future collaboration, including real-time benefits, price transparency, advanced appointment scheduling, clinical trial matching, bulk HL7® Fast Healthcare Interoperability Resources (FHIR®) capabilities, and provider add-on services. CMS encouraged additional organizations to join the initiative as the Health Technology Ecosystem continues to evolve through collaboration across government and the private sector.”
    • “A recording of opening session highlights is available at: https://youtu.be/ATVSdE4cnVQ?si=03QLFmQ2tuRx7w-O
    • “The recording of the full event is available at: https://www.youtube.com/playlist?list=PLaV7m2-zFKpgncdcV8Wnzv42DQo2ZqkUD“
  • Per an NCQA blog post,
    • “The Healthcare Effectiveness Data and Information Set (HEDIS®) is continuously evolving to reflect clinical best practices and to support the needs of organizations that deliver and coordinate care.
    • “For HEDIS Measurement Year (MY) 2027, NCQA introduced several updates:
      • “Added 6 new measures.
      • “Updated 3 existing measures.
      • “Transitioned 1 measure to Electronic Clinical Data Systems (ECDS) reporting.
      • “Restructured ECDS-reported measures reorganized by clinical domain.
      • “Made minor adjustments made across multiple measures.”
    • “NCQA seeks feedback about the proposed retirement of select HEDIS measures for Measurement Year (MY) 2027. The ad hoc public comment period is open from August 3 to August 17. Read on to learn more about the measures proposed for retirement and visit our public comment webpage to submit your comments.
    • “The newest additions to HEDIS address follow-up after a positive colorectal cancer screening, prenatal syphilis screenings, person-centered outcome goals and the use of continuous glucose monitoring.”

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

  • Federal News Network reports,
    • “The Trump administration is giving agencies the green light to implement a new performance management system for federal employees — while also saying significant portions of those changes are “non-negotiable” with federal unions.
    • “In recent guidance issued to agencies, OPM detailed which aspects of the government’s new performance review system override collective bargaining obligations — and what is still subject to negotiation.
    • “Generally, the guidance narrows federal unions’ ability to bargain over performance appraisals. Any collective bargaining provisions that allow for grievances over performance ratings, or that would prevent agencies from using a forced distribution system, are now non-negotiable with unions, according to OPM’s memo.
    • “But some aspects of performance management are still negotiable, according to OPM, as long as they remain consistent with both the final rule and any applicable laws. Those include employees’ informal requests for a reconsideration of their rating; rules on awards and recognition programs; and feedback procedures between supervisors and employees.”
  • The AI Journal relates,
    • “ACI International Inc (NYSE: CACI) announced today that it will serve as one of Oracle’s technology partners for the U.S. Office of Personnel Management’s (OPM) Federal Human Resources Information Technology (HRIT) Modernization contract. Working alongside Oracle, Baker Tilly, and Deloitte on this 10-year contract worth nearly $400 million, CACI will modernize and consolidate disparate federal human resource systems into a single, secure, cloud-based platform for federal civilian employees, including HR professionals and leaders. The consolidation of federal HR systems into a single shared platform is expected to reduce taxpayer costs by more than 90 percent while improving efficiency, security, and service delivery across the government.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Novartis’ blockbuster radioligand therapy Pluvicto has cleared a key milestone on its quest to hit $5 billion in peak sales, securing a U.S. nod in an earlier form of prostate cancer that nearly doubles the number of patients that could benefit from the drug. 
    • “Late Friday, the FDA signed off on Pluvicto in tandem with an androgen receptor pathway inhibitor (ARPI) in patients with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC).”
  • Alzheimers’ News Today relates,
    • “The U.S. Food and Drug Administration (FDA) has granted fast track designation to remlifanserin, an experimental treatment that Acadia Pharmaceuticals is developing for hallucinations and delusions associated with Alzheimer’s disease psychosis.
    • “The FDA grants this designation to investigational medicines intended to treat serious conditions and fill an unmet medical need. Fast track status provides benefits such as more frequent communication with the FDA, with the goal of speeding a therapy’s development and review.
    • “FDA Fast Track designation for remlifanserin underscores the significant unmet need for new treatment options for people living with Alzheimer’s disease psychosis, a serious condition for which there are currently no FDA-approved therapies. This is an important milestone for the remlifanserin program,” Catherine Owen Adams, CEO of Acadia, said in a company press release.”
  • Parkinson’s News Today tells us,
    • “The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to sasineprocel (ANPD001), an experimental cell therapy to treat Parkinson’s disease.
    • “The designation, given to promising regenerative therapies (treatments that aim to replace or restore disease-damaged tissue) that could substantially improve care for serious diseases, provides developer Aspen Neuroscience with perks such as more intensive FDA guidance.
    • “This significant milestone highlights the transformative nature of sasineprocel as a potentially disease-modifying therapy for patients facing a serious disease with substantial unmet medical need,” Damien McDevitt, PhD, president and CEO of Aspen, said in a company press release.” 

From the judicial front,

  • Beckers Payer Issues reports,
    • “Five federal employees are suing U.S. Office of Personnel Management Director Scott Kupor over alleged sex discrimination due to the rollback of coverage for gender-affirming care.
    • “Plaintiffs, backed by the Human Rights Campaign Foundation, filed the lawsuit Aug. 3 in the U.S. District Court for the District of Columbia. The potential class action focuses on OPM’s coverage policy following a January 2025 executive order from President Donald Trump. The order said “sexes are not changeable,” and the country recognizes only male and female sexes.” * * *
    • “The lawsuit calls for two classes, one seeking injunctive relief and the other seeking damages. The complaint also requests retroactive coverage.”
  • STAT News relates,
    • “Sandoz agreed to pay $478.5 million to settle allegations by dozens of states and resellers of medicines that the company engaged in a widespread conspiracy to artificially inflate and manipulate prices of generic drugs and harmed consumers by reducing competition.
    • “Under one settlement, the company agreed to pay $400 million over seven years starting in 2027 to resolve all remaining claims by U.S. states in three pending cases and make an additional payment of about $50 million to states that settled earlier. Another $28.5 million will be paid to resolve all remaining class-action litigation brought by indirect resellers. Sandoz did not admit to any wrongdoing.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Two people have died in connection with the cyclosporiasis outbreak that has spread across the U.S. this summer, according to public-health officials in Michigan, marking the first deaths tied to the unusually large flare up of the food-borne illness.
    • “Both of the people had “significant underlying health conditions” that may have been exacerbated by cyclosporiasis and dehydration, Michigan’s Department of Health and Human Services said. It didn’t provide any additional information about the people who died but said cyclosporiasis deaths are uncommon in the United States.” * * *
    • “The Centers for Disease Control and Prevention said it has received reports of more than 6,700 laboratory-confirmed cases of cyclosporiasis, with another 11,500 suspected. Typically, the U.S. sees about 250 reported cases by this time of year.
    • “The exact source of the parasite remains unclear. Authorities have been probing various cyclospora outbreaks as if they are distinct, but it is possible they are related and investigators so far haven’t been able to connect them. Food-safety experts say the vast majority of fresh fruits and vegetables are still safe to eat.
    • “The largest outbreak has been linked to Taylor Farms’ shredded iceberg lettuce, which was sold at retailers including Taco Bell. On July 17, Taylor Farms said it was removing all iceberg lettuce sourced from central Mexico from the U.S. market. Taco Bell finished pulling potentially affected product from its supply chain on the same day. 
    • “Yum Brands, the parent company of Taco Bell, was in communication with Michigan public-health authorities weeks before the recall, according to emails the health department shared with The Wall Street Journal on Monday. 
    • “In an email to a Yum Brands employee on July 2, a state epidemiologist said the department had “a strong signal from our epidemiologic interviews that we need to continue to work with Taco Bell.” 
  • Fox Business relates,
    • “Marijuana is officially leading the pack for the most-used daily drug among Americans.
    • “New data from the 2025 National Survey on Drug Use and Health, from the Substance Abuse and Mental Health Services Administration (SAMHSA), reveals that there are 21.4 million daily or near-daily marijuana users in the U.S.
    • “This surpasses the 19.9 million people who smoke cigarettes and the 17.2 million who consume alcohol.” * * *
    • Although marijuana is now the most commonly used substance on a daily or near-daily basis, alcohol remains the most widely used substance overall. During the previous month, about 129 million people drank alcohol while 43.8 million used marijuana.
  • Cardiovascular Business tells us,
    • “Twenty years after its launch, the Get With The Guidelines-Heart Failure (GWTG-HF) registry from the American Heart Association (AHA) has grown into one of the nation’s most influential cardiovascular databases, helping accelerate the adoption of guideline-directed medical therapy (GDMT) while generating evidence that has reshaped heart failure care.
    • “Since its inception in 2005, the registry has collected more than 1.6 million patient records from more than 800 hospitals, representing about 60% of U.S. hospitals. The database has produced more than 150 peer-reviewed publications and is increasingly being used to support implementation science, registry-based clinical trials and long-term outcomes research.
    • “What started as a quality improvement initiative has led to substantially better processes of care and, most likely, improved survival, fewer symptoms and a tremendous learning platform,” Clyde W. Yancy, MD, MSc, chief of cardiology and professor of medicine at Northwestern University, said in a video interview with Cardiovascular Business.
    • “He added that the registry was created to solve a longstanding challenge in medicine: the fact that it often takes years for clinical evidence to truly influence changes in daily practice.” 
  • Drug Topics informs us,
    • “A survey study published in JAMA Network Open found that pregnant women and parents of young children generally prefer maternal respiratory syncytial virus (RSV) vaccination over infant RSV antibody shot administration as a means of protecting infants against RSV-associated hospitalization. The 2 concurrent national cross-sectional surveys, fielded in April 2024 among 174 pregnant women and 1765 parents of children aged 0 to 5 years, found that only about half of participants reported positive intentions toward either immunization option, underscoring a persistent gap between product availability and uptake.”
  • Fierce Healthcare lets us know,
    • “A new study evaluating the impact of virtual lactation support found it boosted maternal health and breastfeeding success outcomes. 
    • “The study evaluated SimpliFed, a virtual baby-feeding platform led by UMass Chan Medical School. Participants who completed three or more telelactation visits breastfed for nearly 16 weeks longer than those who did not engage with any visits. The impact was even more drastic for moms with mental health conditions, where average feeding duration increased by 24 weeks. The study, presented as a poster, is not yet published online.
    • “The researchers recruited a group of 200 participants from prenatal through postpartum. All were offered unlimited access to the SimpliFed platform for 12 months. Utilization was evenly split: a third did not complete any visits; a third completed one to two; and a third completed three or more.
    • “Dropping breastfeeding rates over time were common, mirroring national trends. Most participants, regardless of whether they engaged with SimpliFed, breastfed at one week postpartum; three-quarters did by six months; and about half did at 12 months. However, completing three or more SimpliFed visits led to longer duration of breastfeeding compared to others in the cohort.”
  • MedPage Today adds,
    • “A study of U.S. children found no evidence linking neonatal male circumcision with autism spectrum disorder, prospective data from the ECHO cohort showed.
    • “Among nearly 2,800 boys in 14 ECHO sites, 6% of those who were circumcised had autism compared with 9% of uncircumcised males, according to Monica McGrath, ScD, MHS, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, and co-authors.
    • “After adjusting for confounders, circumcision was not associated with an autism diagnosis (OR 0.83, 95% CI 0.59-1.17), McGrath and colleagues reported in JAMA Pediatrics.
    • “Stratifying data by region, preterm birth, and neonatal intensive care unit (NICU) admission yielded either an inverse or no association. Circumcision also was not associated with autism-related traits or behaviors.”
  • Beckers Hospital Review points out,
    • “Active U.S. drug shortages increased to 227 in the second quarter of 2026, marking the third consecutive quarterly increase, according to the American Society of Health-System Pharmacists. Nearly half of all new shortages this year involve medications made by a single manufacturer, a concentration that increases supply chain vulnerability, and the FDA’s database continues to reflect new discontinuations weekly.”
    • The article identifies the nine drugs most recently placed in shortage status.

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

  • The Wall Street Journal reports,
    • “AstraZeneca AZN shares fell sharply and Bristol Myers Squibb’sBMY  climbed, after media reports that the two drugmakers held merger talks.
    • “London-listed shares in AstraZeneca were down 6.4% in European morning trading. Meanwhile, Bristol’s shares were up 5.5% in U.S. premarket trading.
    • “The stock moves came after the Financial Times reported, citing unnamed sources, that AstraZeneca held discussions with Bristol about a tie-up in recent months, which could lead to a deal in the near future or fall apart.
    • “An AstraZeneca spokesman declined to comment, while Bristol didn’t respond to a request for comment.
    • “A potential deal between AstraZeneca and Bristol Myers Squibb would create a pharma giant with a combined market value of roughly $400 billion and more than $100 billion in annual sales.”
  • Beckers Hospital Review relates,
    • :Gaithersburg, Md.-based Adventist HealthCare recorded operating income of $18.2 million (3% operating margin) through the first six months of fiscal 2026, up from an operating loss of $205,000 (-0.1% margin) during the same period last year, according to its July 29 financial report.” * * *
    • “Among the system’s hospitals, Silver Spring, Md.-based White Oak Medical Center posted $11.9 million in operating income through Q2, up from a $2.8 million operating loss during the same period last year. Rockville, Md.-based Shady Grove Medical Center posted $16.5 million in operating income, up from $10.2 million. Fort Washington (Md.) Medical Center Medical Center posted a $1.2 million operating loss, widened from a $960,000 loss during the same period last year.”  
  • Beckers Behavioral Health tells us,
    • “Ochsner Behavioral Health Acadiana welcomed its first patients July 8, marking the official launch of a regional behavioral health network built jointly by Ochsner Lafayette (La.) General and Plano, Texas-based Oceans Healthcare. 
    • “The network pairs a newly built hospital in Lafayette with the former Oceans Behavioral Hospital Broussard, now renamed Ochsner Behavioral Health Acadiana-Broussard, giving the partners 100 inpatient beds across the two campuses under a single license — more than double the 38 beds they previously operated in the region.
    • “The logic behind the partnership, Oceans Healthcare COO Jeff Pritchard said, comes down to completing the continuum.
    • “Many patients come through the doors of a health system; they have ERs, they have hospitals, they have various clinics,” he said. “By forging a connection with them, we can create a path to those patients who need behavioral health support, so there’s no loss of care in the transition.”
  • Cardiovascular Business informs us,
    • “Cleerly, a Denver-based artificial intelligence (AI) company, has partnered with New York-based Allelica to launch the new Cleerly Polygenic Cardiovascular Risk Score Test. 
    • “Allelica specializes in polygenic risk scores (PRS) that predict a patient’s genetic risk of developing different diseases. Cleerly, meanwhile, its known for its AI-powered coronary CT angiography (CCTA) evaluations. Together, these two companies have collaborated on a new test designed to help physicians diagnose and manage heart patients with suspected coronary artery disease.
    • “Genetic risk and imaging answer two different questions for a physician,” James K. Min, MD, FACC, FESC, MSCCT, founder and CEO of Cleerly, said in a statement. “Inherited risk points to who is biologically predisposed to coronary disease, and our imaging analysis shows what is actually present inside the arteries. Bringing those two views together gives physicians a clearer, more individualized picture of each patient’s coronary risk.”
  • Per BioPharma Dive,
    • “Brain drug developers Supernus and Individor on Monday announced plans to merge, bringing together two companies specializing in drugs for central nervous system disorders that had combined revenues of $2 billion in 2025.
    • “Per deal terms, Supernus shareholders will receive 1.54 shares of Individor for every Supernus share they own, and Individor shareholders will receive a one-time $1 billion cash dividend before the deal’s close, financed by a $650 million loan and the combined companies’ cash on hand. After the close, the former Individor shareholders will own around 57% of the combined company and Supernus’ will own around 43%.
    • “Following the close, the company will be called Supernus, headquartered at Supernus’ Rockville, Maryland offices, and will be headed by its current CEO, Jack Khattar. Individor board member Tony Kingsley will become the combined company’s board chair. The board is expected to consist of eight members evenly split between Individor and Supernus.”
  • Per MedTech Dive,
    • “Global investment firm KKR said Monday it has agreed to buy device manufacturer Integer Holdings for about $5.7 billion.
    • “The companies expect to close the deal before the end of the year, at which point Integer would become a private company. Shares of Integer rose by nearly 20% to $121.21 Friday afternoon following a Wall Street Journal report that the two companies were nearing a deal.
    • “Integer, which bills itself as one of the largest global medical device contract development and manufacturing organizations, expects the acquisition would provide flexibility and long-term capital to invest in its capacity, technology and innovation.”

Friday report

David Ermer–Agentic & Generative AI, CDC, Congress, COVID-19, FDA, Medical / Rx research, Mental health care, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “Speaker Mike Johnson, R-La., defied expectations and kept his fractured conference together to pass several priority items before House members jetted home on Thursday to kick off a five-week recess. 
    • “But how much of that legislation their colleagues in the Senate will take up is a different question, as divisions continue to deepen.
    • “The House adopted a GOP-backed budget resolution along party lines on Wednesday, taking the first step toward passing a $95 billion reconciliation package that’s focused mostly on the Iran war. 
    • “But Senate Majority Leader John Thune, R-S.D. has remained lukewarm on such a package, especially if it includes certain aspects of the so-called SAVE America Act, which would require proof of citizenship to register to vote and photo ID at the polls. 
    • “I can’t count 50 right now on a budget resolution,” Thune told reporters on Thursday. He said the path to clearing the chamber’s so-called Byrd bath, which assesses compliance with reconciliation rules, “is still an open question.”
  • Beckers Clinical Leadership relates,
    • “HHS has rewritten the governing charters for the Advisory Commission on Childhood Vaccines and the National Vaccine Advisory Committee.
    • “The ACCV charter, filed July 21, removes the standalone designated federal officer section that appeared in the previous version, which specified that a full-time federal employee would approve meeting agendas, call meetings and maintain public-facing information on the committee’s activities.
    • “In its place, the new charter refers more broadly to “the federal official responsible for ACCV oversight” calling or approving meetings. The revised charter also adds a provision allowing that federal official, if appointed by the HRSA administrator, to serve as temporary chair if ACCV members have not selected a chair and vice chair. The ACCV advises the HHS secretary on the National Vaccine Injury Compensation Program, including changes to the Vaccine Injury Table and how the government collects and uses vaccine adverse event data.
    • “The revised NVAC charter adds duties not previously included in the panel’s purview, directing members to weigh what it terms “non-immunization strategies,” including healthy lifestyle and disease prevention initiatives, off-label use of already approved drugs and dietary supplements marketed for immune support.”
  • Govexex tells us,
    • “The National Active and Retired Federal Employees Association on Thursday said the Office of Personnel Management still has not sufficiently protected federal workers and retirees as part of a plan to collect claims-level health data in an effort to root out fraud.” * * *
    • “[I]n a letter to [OPM Director Scott] Kupor Thursday, NARFE National President William Shackelford said that while his organization appreciates the steps taken thus far to shield FEHBP and PSHBP participants’ identities, he remains troubled by OPM’s insistence that it be able to re-identify employees via their health records in the future. Under the Health Insurance Portability and Accountability Act, health care data should be not just pseudonymized, but de-identified entirely, he wrote.
    • “NARFE’s position is straightforward. OPM has moved in the right direction,” Shackelford wrote. “But we asked for de-identified data and OPM has offered pseudonymized data, and those are not the same commitment. Pseudonymization does not remove the risk that our members’ health information will be linked back to them; it makes that linkage a matter of OPM’s discretion, exercisable by whoever holds the relevant authority in any future administration.”
    • “Additionally, most of OPM’s reassurances about privacy and the data collection’s anti-fraud purpose exist solely within Kupor’s blog post, and not the proposal published in the Federal Register last month.”
  • Over 700 public comments were submitted by yesterday’s deadline. As the FEHBlog has noted, OPM is not giving FEHB and PSHB carriers and the OPM Inspector General credit for preventing most fraud, waste and abuse in these programs.
  • The American Hospital Association News informs us,
    • “The U.S. Trade Representative yesterday announced it is implementing a 10% or 12.5% tariff on 60 trading partners, which became effective today. These tariffs follow an investigation under Section 301 of the Trade Act of 1974 for lacking or failing to enforce a ban on goods produced with forced labor, according to the agency. Nations that the USTR said had made commitments to adopt and effectively enforce forced labor import prohibitions will receive a 10% tariff, while nations that the agency said had failed to adopt a forced labor import ban will receive a 12.5% tariff. The USTR notice outlines which products are excluded from the new tariffs, including products already subject to Section 232 tariffs, products qualifying under the U.S.-Mexico-Canada trade agreement and certain pharmaceuticals and pharmaceutical ingredients.”
  • and
    • “The Consumer Product Safety Commission yesterday announced it is modernizing the National Electronic Injury Surveillance System, the national database for tracking consumer product-related injuries. The CPSC said that it will replace its manual coding process, used since 1972, with an electronic data exchange through a Qualified Information Network. The new system, NEISS-Remodel, will expand the network to all 50 states, up from 36 under the previous system. NEISS-R is expected to become fully operational by the beginning of 2027.” 

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • It’s been over two months since Dr. Marty Makary stepped down from his post as FDA commissioner, and there has yet to be visible progress toward naming his permanent successor. The gap in leadership is sparking concerns among industry watchdogs that pharma could lack clear guidance on federal priorities for weeks or months to come.
    • The Trump administration has yet to name a nominee to replace acting commissioner Kyle Diamantas — and there are currently multiple hurdles in front of any confirmation process. In particular, the Senate isn’t going to be around much in the coming months. 
  • The Wall Street Journal relates,
    • “Biohackers, longevity enthusiasts and alternative medicine doctors want the peptide BPC-157. Now compounders may be one step closer to lawfully providing it. 
    • “The Food and Drug Administration’s Pharmacy Compounding Advisory Committee voted in favor of easing restrictions on six of seven peptides up for consideration, following strong warnings from the agency’s scientists. It’s now up to the FDA to decide whether to greenlight the drugs for compounding pharmacies to make—and pave the way for a peptide gold rush.
    • * * * “The committee voted against one peptide called Emideltide, evaluated for opioid withdrawal, chronic insomnia, and narcolepsy. David Pope, a pharmacist who voted affirmatively for other peptides, voted “no” on this one, citing a complex regimen and “potentially dangerous downstream consequences.”
  • USA Today tells us,
    • “Consumers will soon have a new over-the-counter pain relief option that combines Tylenol with naproxen, an anti-inflammatory medication.
    • “The Food and Drug Administration on July 24 approved the non-prescription combination of 650 mg of Tylenol (acetaminophen) and 220 mg of naproxen sodium.
    • “The non-opioid tablet can be used by adults and children aged 12 and ​older for temporary relief of headaches, back pain, muscle aches, toothache, menstrual cramps and minor pain from arthritis, the FDA said.
    • ‘Kenvue, which owns Tylenol, said the tablet combination will soon be available for purchase without a prescription at major retailers.”
  • Fierce Pharma informs us,
    • “With all eyes on Tavneos’ seemingly precarious approval status in the U.S., Amgen is advancing plans to defend the ANCA-associated vasculitis (AAV) drug it inherited in its $3.7 billion buyout of ChemoCentryx. 
    • “The California pharma on Thursday submitted data and analyses to the FDA to help secure a hearing in hopes of keeping Tavneos on the U.S. market. The package includes a third-party re-evaluation of the med’s controversial pivotal trial, real-world evidence and patient and HCP testimonials.
  • Cardiovascular Business lets us know,
    • “Penumbra is recalling specific lots of its RED 68 Perfusion Catheter due to an ongoing safety concern. 
    • “The U.S. Food and Drug Administration (FDA) has ruled that this is a Class II recall. This means using the device without following the manufacturer’s recommendations could lead to “temporary or medically reversible adverse health consequences.” 
    • ‘The recall was put in place due to a risk of the catheters fracturing. Penumbra has said “manufacturing issues” are to blame, but the company is still investigating the issue to learn more.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of July 24, 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) is elevated nationally. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The American Hospital Association News reports,
    • “There have been 2,318 confirmed measles cases in the U.S. so far this year, the most in the country since 1991, according to the latest data from the Centers for Disease Control and Prevention. There were 2,289 cases in 2025. Cases this year have been reported by 45 jurisdictions. The CDC said that 93% of cases are outbreak-associated. The vaccination status of 93% of cases is unvaccinated or unknown. The agency said that 7% of cases this year have been hospitalized, lower than last year’s figure of 11%.”
  • The Washington Post offers an opportunity to check out your county’ measles vaccination rates for kindgarteners.
    • “The share of U.S. counties where 95 percent or more of kindergartners were vaccinated against measles — the number doctors say is needed to achieve overall protection for the class, known as “herd immunity” — has dropped from 50 percent before the pandemic to 28 percent, according to The Post’s examination of the public records from 44 states and the District of Columbia.”
  • The Wall Street Journal tells us,
    • “Public-health officials are investigating four additional states as part of a multistate cyclospora outbreak linked to iceberg lettuce that they warn could be even broader.
    • Illinois, Kansas, Oklahoma and Pennsylvania are the latest states added to the investigation, the Centers for Disease Control and Prevention said Friday. The health agency said last week it was investigating the outbreak in Indiana, Kentucky, Michigan, Ohio and West Virginia. 
    • “The CDC said epidemiologic data continued to show the outbreak stemmed from the consumption of iceberg lettuce from Taylor Farms. Nearly 2,000 people who ate food from Taco Bell have been sickened in those nine states during the outbreak, the agency said. Nearly 100 people have been hospitalized. 
    • “The iceberg-lettuce outbreak might be even broader than what health authorities have found. The authorities are investigating a number of food-related outbreaks, including several involving cyclospora, a parasite that causes explosive diarrhea. For now, the authorities are probing the various cyclospora outbreaks as if they are distinct, but it is possible they are related and investigators so far haven’t been able to connect them.”
  • and
    • “Warmer winters and changes in land use are driving ticks carrying Lyme disease and alpha-gal syndrome into new areas such as Ohio and Michigan.
    • “In 2025, Lyme disease cases jumped more than 60% in Ohio and almost 80% in Michigan as blacklegged tick populations expanded.
    • “Lone-star ticks, which cause the meat allergy alpha-gal syndrome, are established in 19 counties in Ohio and five in Michigan.”
  • The New York Times points out,
    • “The same chemical process that turns a baking cake golden brown is at work aging your body’s cells. Over decades, your tissues, baking steadily at 98.6 degrees, slowly accumulate compounds called advanced glycation end products, or AGEs, as sugars interact with protein and fat in the bloodstream. The buildup of AGEs is a hallmark of the aging process, making tissues like collagen sticky and rigid and causing inflammation that can lead to heart disease, eye damage, kidney disease and diabetes.
    • “Researchers have tried unsuccessfully to develop medications that can stop AGEs from forming. But a new study, published on July 16 in the journal Nature Communications, describes a different tack: Scientists created an enzyme that cleans one of the most common AGEs from human tissue, helping to turn back the clock even after the aging compounds have settled in the body. This cleanse can help repair the tissue and has the potential to allow cells to act younger.
    • “It’s a small step in this bigger direction, because aging is very complicated,” said Aaron Cravens, a founder and the chief executive of Revel Pharmaceuticals, which developed the new enzyme, and the lead author of the study. “It’s the first time, I think, that anyone in the field has shown at the structural level that you can actually reverse some of these changes.”
  • MedPage adds,
    • “Exceptional memory at age 80 and beyond was not due simply to good genes, an analysis of prospective data suggested.
    • “The study assessed outcomes for superagers — people 80 or older with episodic memory at least as good as adults 20 or 30 years younger — and cognitively average controls.
    • “Genotype distributions and APOE status did not differ between groups, reported Ignazio Stefano Piras, PhD, of the Translational Genomics Research Institute at City of Hope in Phoenix, and co-authors.
    • “Neither APOE nor any of three polygenic risk scores predicted whether a person would be a superager, Piras and colleagues wrote in Alzheimer’s Research & Therapy. Results were similar after accounting for global non-European or African ancestry.”
  • Health Day informs us,
    • “About 50% to 88% of children with autism experience motor skill challenges
    • “Organized sports — especially martial arts and aquatic training — can improve motor skills
    • “Consistently large improvements were seen in balance, coordination, overall motor skills and object control.”
  • and
    • “Increases in a problematic social media use may contribute to worsening attention-deficit/hyperactivity disorder (ADHD) symptoms during adolescence, particularly among boys, according to a study published online July 17 in JAMA Network Open.”
  • The Wall Street Journal notes,
    • “Ipsen said its drug Bylvay missed the primary objective in a late-stage clinical trial for biliary atresia, a rare liver disease affecting babies.
    • “Bylvay missed the study’s primary objective of showing an improvement in native liver survival rates compared to a placebo, Ipsen said.
    • “Ipsen said biliary atresia, the leading cause of pediatric liver transplants, has no approved therapeutic options beyond surgery or transplant.”
  • Per BioPharma Dive,
    • “Sanofi is calling it quits on an experimental eczema drug that it had seen as a potential successor to its blockbuster medication Dupixent, according to a Friday announcement.
    • “Sanofi had said in January that it intended to seek clearance of the drug, amlitelimab, in atopic dermatitis despite mixed late-stage study results and signs of possible safety concerns. On Friday, though, the French pharmaceutical firm said that, during a pipeline review, it found that the “totality of efficacy and safety evidence generated to date” doesn’t support further development of amlitelimab in that indication.
    • “Sanofi’s decision follows a recent move by Amgen and Kyowa Kirin to shelve a similar experimental medicine. The pharma company will continue testing amlitelimab in celiac disease, though, and is slated to reveal data from a mid-stage study by the end of the year.”

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

  • Fierce Healthcare reports,
    • “HCA Healthcare on Friday affirmed its earlier warnings about Affordable Care Act (ACA) exchange subsidies fallout, telling analysts that patients who dropped off marketplace plan coverage due to increased premiums have “migrated almost one for one” to uninsurance. 
    • “The country’s largest for-profit brought in $20.23 billion in second-quarter revenue, up 8.7% year-over-year, net income of $1.69 billion, up 2.8%, and adjusted EBITDA of $4.027 billion, up 4.6%, according to financial results published Friday morning. The company also reported diluted earnings per share increasing 11.6% to $7.62 per share.
    • “In particular, a payer mix shift driven by increased uninsured volumes had an “unfavorable impact” on income of approximately $400 million before income taxes, above its estimates from earlier in the year.”
  • and
    • “Clinician-led artificial intelligence platform Anterior and health tech company Stellarus entered a strategic partnership Thursday to tackle automating prior authorizations.
    • “The partnership aims to support providers through automating tasks—such as case research and policy application—to allow teams to focus on complex determinations. The companies say providers will receive quicker, first-time approvals, ultimately giving members quicker care access. 
    • “Stellarus provides the healthcare technology platform, integration expertise and operational experience to help health plans put AI into practice, while Anterior brings leading clinical AI to automate the research, documentation and policy application that support prior authorization,” said Vanessa Colella, Stellarus president and CEO.”
  • and
    • “Addressing healthcare’s biggest challenges will require payers and providers working together.
    • “That’s why the team at Aetna has spent the past several years investing in ways to bridge those trust gaps and better unite the two sides of the industry that are often at odds. And a new survey suggests that work is paying off.
    • “Morning Consult polled 723 provider executives across multiple disciplines on Aetna’s behalf, and found an average provider trust score of 6.1 on a scale of one to 10. By comparison, a similar poll conducted in the first quarter found a 5.4 trust score.”
  • Modern Healthcare relates,
    • “Surgery Partners plans to sell its ownership interest in two Idaho hospitals to Intermountain Health.
    • ‘The proposed transaction, which values the facilities at an estimated $1.15 billion, would include Surgery Partners’ Idaho Falls Community Hospital and Mountain View Hospital, also in Idaho Falls, along with affiliated clinics.
    • “Surgery Partners is expected to receive about $795 million in the transaction, according to a Friday news release.”
       
  • MedTech Dive tells us,
    • “Edwards Lifesciences reported strong sales of its heart valves in the second quarter and outlined several upcoming catalysts expected to maintain solid growth rates, starting with an anticipated Medicare coverage expansion.
    • “Sales were better than the company expected for transcatheter aortic valve replacement devices, Edwards’ largest product line, as well as newer repair and replacement treatments for mitral and tricuspid diseases, due to increasing clinical demand, executives said on a Thursday earnings call.
    • “CEO Bernard Zovighian tied TAVR demand to growing evidence backing earlier use of the procedure to treat aortic stenosis patients and predicted the “durable” momentum would support the company’s 10% total sales growth target long term.”
  • Fierce Pharma informs us,
    • “After a post-[July 4th] holiday lull, prescriptions for GLP-1s have more than bounced back. Weekly prescriptions for Novo Nordisk’s Wegovy pill and Eli Lilly’s Foundayo reached new highs during the previous week, collecting 169,800 and 26,760, respectively, according to IQVIA data cited by Citi. The two oral drugs’ previous records were about 161.5K and 24.3K, respectively. 
    • “Other GLP-1 drugs also enjoyed a boost, as total GLP-1 scripts across obesity and diabetes increased 6.6% sequentially, according to Citi.
    • “Against this backdrop, Lilly’s oral Foundayo seemed to enjoy a small inflection point, with a total 24,303 scripts notably breaking away from its roughly 20K level in the prior five weeks.  
    • “Meanwhile, joining the bigger trend, Wegovy pill scripts dropped to 147.5K during the week, versus about 153K the prior week or 161.5K at its peak. But the contribution of the oral version to the overall Wegovy scripts remained stable at around a third, per Citi’s note.” 

Tuesday report

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

Simplicity is a virtue.

From Washington, DC,

  • The Washington Post tells us,
    • “The House passed a stopgap bill to fund the government into December in an effort to avoid another government shutdown weeks before the midterms, but the effort faces an uphill climb in the Senate.
    • “The resolution, which would fund the government through Dec. 4, passed 220-205. 
    • “House Speaker Mike Johnson (R-Louisiana) pushed the measure to preempt a showdown with Democrats in the fall over government funding as lawmakers are unlikely to meet a Sept. 30 deadline ahead of the new fiscal year.” * * *
    • “Senate Majority Leader John Thune (R-South Dakota) said he’ll bring a bipartisan agreement to fund the government to the floor before the August break. That measure would then need to be approved by the House when lawmakers return at the end of August before it goes to Trump’s desk.”
  • Per a Department of Health and Human Services news release,
    • “The U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) today deferred more than $1 billion in federal Medicaid payments to California and Minnesota as the states submit additional documentation supporting certain high-risk Medicaid claims. The action advances the Trump administration’s effort to combat fraud, waste, and abuse in Medicaid and safeguard federal taxpayer dollars.” * * *
    • “CMS is deferring approximately $867.5 million in federal Medicaid payments to California and $199 million to Minnesota after focused financial reviews identified claims that require additional review before federal matching funds are released. These are payment deferrals (not permanent funding cuts) and both states will have the opportunity to provide documentation showing the claims meet federal Medicaid requirements.
    • “Additionally, under Secretary Kennedy’s direction, HHS and the HHS Office of Inspector General continue to exercise exclusion authorities as a critical tool to remove bad actors from Medicare and Medicaid programs — and, in many cases, permanently bar them from returning.”
  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services today released a proposed rule that would update Medicaid provider tax policies included in the July 2025 reconciliation law and change how the agency determines whether certain healthcare taxes comply with federal requirements. States commonly use provider taxes to help finance Medicaid. CMS said the proposed changes are intended to ensure those taxes are not structured in a way that effectively guarantees providers receive their tax payments back. 
    • “The proposal would replace the current 6% indirect hold harmless threshold with state- and provider class-specific thresholds based on taxes enacted and imposed as of July 4, 2025, and would implement a phased reduction in allowable thresholds for Medicaid expansion states beginning in fiscal year 2028. The rule proposes revised interpretations of “enacted” and “imposed” taxes as described in CMS’ preliminary guidance issued Nov.14, 2025. CMS also proposes to sunset the current alternative “75/75” compliance test and establish a new provider tax class, “Services of Health Insurers,” bringing existing state taxes on health insurers under CMS oversight. 
    • “Comments are due 60 days after publication in the Federal Register.” 
  • Govexec relates,
    • “The Office of Personnel Management is set to propose new rules this week implementing a 2022 law aimed at reforming retirement benefits for federal first responders who are injured during their service and forced to pursue jobs elsewhere in government.
    • “Federal workers in professions like law enforcement and firefighting participate in the federal government’s defined benefit retirement program on an accelerated basis—in exchange for paying more toward their pensions each paycheck, they become eligible for their full annuity once they have served 20 years and reached age 50. They are also subject to mandatory retirement at age 57.
    • “But if a federal first responder is injured on the job and unable to continue in their current role, they lose access to the accelerated retirement timeline, despite the increased payments they have already made along the way.
    • “A proposed rule set for publication Wednesday in the Federal Register would implement the First Responder Fair RETIRE Act, a 2022 law aimed at fixing this flaw. The legislation allows first responders forced to take a job elsewhere in the federal government to continue to pay accelerated contributions and reach retirement when they originally planned. And it grants feds the chance to be refunded the extra half-percentage point of their salary that went toward retirement if they leave federal service altogether prior to reaching retirement age.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “The FDA added eight new members to an advisory committee slated to review whether pharmacies can legally market peptides, after criticism the panel is stacked with those tied to peptide-related businesses and clinics.
    • “The panelists were added as temporary voting members to the Pharmacy Compounding Advisory Committee, which is scheduled to convene Thursday and Friday to evaluate whether seven unapproved peptides can be reclassified to allow pharmacies to legally manufacture them. The committee will consider whether to reverse a 2023 Biden-era decision that nearly 20 peptides pose safety risks and can no longer be legally compounded.
    • “The temporary members include clinical researchers, professors of medicine, and pain and substance use experts.
    • “They seem considerably more qualified and less conflicted than the others who were added recently,” Peter Lurie, a former FDA associate commissioner, now the president of the Center for Science in the Public Interest, said in an email. “The new members are mostly confined to certain peptides, not the case for the earlier nominees.”
  • MedTech Dive relates,
    • “Philips received 510(k) clearance for a new version of its pulse oximeter clip sensor that the company says is accurate across a broad range of skin tones. 
    • “The reusable clip sensor has optical refinements to improve signal quality and measurement consistency and support reliable oxygen saturation measurements across diverse patient populations and clinical conditions, the company said in the Tuesday announcement. 
    • “Medtech firms have sought to update their pulse oximetry technology after several studies raised concerns about the devices being less accurate for people with dark skin pigmentation. The Food and Drug Administration issued updated testing recommendations for pulse oximeters in a 2025 draft guidance, but has not finalized it.”

From the judicial front,

  • The American Hospital Association News reports,
    • “The U.S. District Court for the District of Columbia July 21 upheld a lower court’s decision that Section 340B of the Public Health Service Act does not permit drug companies to impose proposed rebate models on 340B purchasers unless the Secretary of the Department of Health and Human Services approves. The court did not weigh in on the lawfulness of the department’s proposed rebate program or any other version of a rebate model that it could approve.  
    • “The manufacturers’ reading would also counterintuitively let manufacturers, rather than the Secretary, take the lead in administering the 340B Program, rendering the Secretary’s role largely reactive,” the court explained. “Put simply, the statute places the Secretary, not the manufacturers, in the driver’s seat of this important program.” 
  • FEHBlog observation: By upholding a lower court’s decision, the article is referring to an initial decision by a Magistrate Judge.
  • BioPharma Dive relates,
    • “Novo Nordisk is suing its biggest obesity drug rival, alleging on Tuesday that Eli Lilly is engaging in deceptive advertising by intentionally using outdated studies to compare the higher doses of its medicines to lower doses of Novo’s products.
    • “Filed in a New Jersey [U.S.] District Court, the lawsuit follows a cease-and-desist order in which Novo asked Lilly to take down the advertisements. Lilly hasn’t, so the Danish drugmaker is seeking a permanent injunction to get the ads pulled and for Lilly to “conduct a corrective advertising campaign.” Lilly countered in a statement that the advertising is “truthful, it is transparent, and it is grounded in the most direct scientific evidence available.”
    • “The lawsuit comes as Lilly has gotten the upper hand in a high-stakes battle for market share. Lilly’s medicine, Zepbound, recorded $4 billion in sales in the first quarter of 2026 compared with the 18.2 billion krone, or $2.7 billion, generated by Novo’s Wegovy. The turf war escalated this year with both companies launching obesity pills that could extend the reach of weight-loss medicines.”
  • Per a Department of Justice news release,
    • “A foreign national was arrested yesterday on criminal charges related to his orchestration of a scheme to defraud Medicare over half a billion dollars for unnecessary genetic testing.
    • “Khalid Satary, 54, was charged by indictment in 2019 in the Eastern District of Louisiana as part of one of the largest health care fraud schemes ever charged by the Department of Justice. According to the indictment and court documents, from 2016 to 2019, Satary owned and operated several diagnostic testing laboratories throughout the United States that billed Medicare for expensive and medically unnecessary genetic tests. Satary allegedly conspired with dozens of patient recruiters, telemarketing call centers, and telemedicine companies to utilize deceptive marketing campaigns and illegal kickbacks and bribes to generate cancer genetic test samples that reimbursed between $10,000 to $20,000 per sample. Through his laboratories, Satary billed Medicare for over $547 million. He also allegedly paid millions of dollars in illegal kickbacks and bribes to doctors and patient recruiters. In connection with the indictment, the government seized 16 bank accounts and restrained real estate from Satary.”

From the public health and medical / Rx research front,

  • Phrma reports,
    • “A new study published in The Lancet offers some of the strongest real-world evidence to date that vaccination against human papillomavirus (HPV) is saving lives.” * * *
    • “Researchers say these findings indicate that eliminating cervical cancer is now an achievable goal. But that progress depends on maintaining timely and high vaccination rates with policies that support coverage and access to vaccines.
    • “The new findings, drawing on population-level disease surveillance, show that HPV vaccination is changing what is possible in cancer prevention.
    • “Policymakers should support policies that preserve access and help ensure families can get recommended vaccines without unnecessary barriers.”
  • Medscape adds,
    • More than 80% of patients with early Alzheimer’s disease (AD) treated with lecanemab (Leqembi, Eisai/Biogen) in routine practice remained clinically stable or improved over an average of 17 months of treatment, an interim analysis of the real-world LEADER study showed.
    • The real-world safety profile of the antiamyloid therapy was consistent with the drug’s US prescribing information, with most amyloid-related imaging abnormalities (ARIA) being asymptomatic and mild.
  • The AP relates,
    • “Road deaths are declining in the U.S. and worldwide, but lower-income countries aren’t experiencing much of the improvement, according to a study published Monday.
    • “Global rates of road injuries and deaths each fell more than 30% between 1990 and 2023, according to the study published in Lancet Public Health, which noted the progress varied from country to country.
    • “Pedestrian and vehicle occupant deaths rose over that time in six countries — including the United States. However, more recent data shows road deaths fell in the U.S. in 2024 and 2025.”
  • The New York Times tells us,
    • “Diet is one of the most important factors shaping health, but it’s surprisingly difficult for researchers to figure out what people eat.
    • “Researchers’ usual tools, like food frequency questionnaires or asking people to recall what they ate the day before, are tedious and expensive, said Christopher Gardner, a nutrition scientist at Stanford. Such efforts depend on people being candid and accurate; people forget about 15 to 20 percent of what they ate after a few days.
    • “It’s one of the reasons that nutrition research is so difficult and why the best evidence comes from small metabolic chamber studies, Dr. Gardner said. In such studies, researchers essentially “incarcerate someone,” he added. “They can’t leave. You cook the food for them, you slide it under the door, you know if they didn’t finish it.”
    • ‘But a new study, published today in the Proceedings of the National Academy of Sciences, points to a treasure trove of nutrition data: sewage. Using wastewater in North Carolina, researchers searched for traces of food DNA that had survived digestion. For less than a penny a person, they identified hundreds of foods that had been consumed — like chocolate, lettuce, turkey, blueberries, black pepper — and could even infer the socioeconomic profile of a community.”
  • The Wall Street Journal informs us,
    • “When Molly Taylor started taking Mounjaro in the fall of 2024, she marveled at the speed of results. She wasn’t overweight, but she hadn’t been comfortable in her body. Now, she could eat whatever she wanted, just in smaller portions, and people were complimenting her looks. She no longer felt self-conscious. 
    • “Then her mindset began to shift. 
    • “I gradually started to worry about what I was eating, how many calories were in it, if it was going to stop me from losing more weight,” said the 23-year-old nanny, who is studying to be a nurse in London. “I think that’s when I was starting to develop anorexia.” 
    • “GLP-1s have been hailed as miracle drugs, their rise leading to critical breakthroughs in America’s fight against obesity. Roughly 13 million Americans are now on them, according to research from JPMorgan published in February. The drugs mimic naturally occurring hormones to suppress appetite and cravings and make people feel full. For those who’ve struggled with restrictive eating and anorexia, that can be a tantalizing proposition—and a dangerous one. 
    • “Anorexia kills a higher percentage of patients than any other eating disorder, and it is the second most deadly mental illness after opioid addiction, according to data compiled by the nonprofit National Association of Anorexia Nervosa and Associated Disorders.”
  • Cigna Healthcare, writing in LinkedIn, points out,
    • “Mental health challenges rarely arrive as a single, dramatic moment. More often, they accumulate quietly—sleep gets lighter, patience gets shorter, motivation slips, and everyday tasks start to take more effort than they used to. People may still be showing up and getting things done, but with less ease, less connection, and lower reserves.
    • “Telehealth and evidence-based mental health apps can make care easier to access and easier to stick with. When support fits more naturally into real life, people are more likely to seek help sooner. That often shows up at work as steadier attention, clearer communication, more consistent follow-through, and fewer days of simply pushing through.” * * *
    • “Telehealth and mental health apps won’t solve every problem, but they can make it easier to get help sooner and stay with it. For many common needs, the evidence suggests remote therapy can be as effective as in-person care, and structured digital programs can reinforce skills between sessions. In practice, that can make day-to-day life feel more manageable.”
  • MedPage Today offers us “The Roadmap to DSM-6 — A look at conflicts of interest in the formation of psychiatry’s playbook.”
  • Health Day notes,
    • “Snoring at night might not just disrupt a partner or pets; it could also impact memory function and dementia risk.
    • “A new study in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Associationexamined the link between obstructive sleep apnea (OSA), memory and dementia risk. Researchers used cognition testing on adults aged 40 to 77 to compare people with and without the sleep disorder.
    • “Those with untreated OSA had worse cognition and memory function. They also had an increased dementia risk. 
    • “If the sleep apnea was treated, however, that changed. Adults who managed their apnea had brain testing results on par with adults without it.”
  • Per Radiology Business,
    • “A significant number of incidental breast masses are overlooked on CT scans of the chest, which could potentially lead to delays in diagnosis and treatment, researchers caution. 
    • “A new Academic Radiology analysis of incidentally detected cancers suggests that up to two-thirds of visible breast masses on emergency chest CTs go unnoticed by readers. At once center, such misses resulted in significant delays in cancer diagnosis, up to 33 months in some cases.  
    • “Although emergency chest CT scans are usually completed for other clinical indications, experts involved in the study say they present an opportunity to catch cancer earlier. However, visible lesions on these scans often are overlooked. 
    • “In recent years, especially with the COVID-19 pandemic, a significant increase in CT use in emergency departments has been observed,” Olgun Sahin, MD, with the Department of Radiology, Izmir City Hospital in Turkey, and colleagues explained. “The increasing number of chest CT scans is assumed to lead to a corresponding increase in the detection of incidental breast cancers. However, despite this increased detection potential, published data on clinical practice is striking. A retrospective study by Park et al. revealed that 64.3% of incidental breast cancers were missed in initial chest CT reporting. Similarly, Abougazia et al. recently reported 67.9% of such cases.” 
  • Per Fierce Pharma,
    • “Detailed phase 3 results suggest the two-drug combination of Gilead Sciences’ lenacapavir and Merck & Co.’s islatravir has what it takes to become the first complete weekly pill for the treatment of HIV.
    • “Two Islend clinical trials confirmed that a once-weekly, single-tablet combination of islatravir and lenacapavir (ISL/LEN) matches daily treatments like Gilead’s Biktarvy at maintaining HIV viral suppression, according to data slated for presentation at the 26th International AIDS Conference in Rio de Janeiro, Brazil. 
    • “Positioned to become the first complete weekly oral HIV treatment, ISL/LEN combines a major scientific leap with the promise of meeting diverse patient needs, Jared Baeten, M.D., Ph.D., Gilead’s clinical development lead in virology, said in an interview with Fierce Pharma.”
  • Per BioPharma Dive,
    • “Agios Pharmaceuticals has decided not to further develop one of its more closely watched medicines as a treatment for sickle cell disease due to disappointing results from a mid-stage clinical trial.
    • “The drug, called tebapivat, “did not demonstrate the level of differentiation required to support continued development,” Agios said in a statement. Tebapivat has been billed as a “next-generation” version of another Agios medicine, mitapivat, which is already approved for use in two blood disorders. These drugs work by activating the “pyruvate kinase” enzyme that’s essential for the health and survival of red blood cells.”

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

  • Modern Healthcare reports,
    • “Hospital systems are improving care transitions to help offset an expected decline of post-acute providers. 
    • “Systems are preparing for fewer post-acute referral partners, which could increase their costs, reduce revenue and slow patients’ recovery after a hospital stay. Home health, skilled-nursing, rehabilitation and hospice facilities are the focus of a sweeping fraud crackdown that has stripped some post-acute providers of their Medicare eligibility. Also, in May, the Centers for Medicare and Medicaid Services announced a six-month moratorium on new Medicare enrollment of hospices and home health agencies.
    • “The increased oversight threatens to exacerbate persistent inpatient discharge delays that are limiting access to care. Hospital systems have not experienced additional care transition hurdles yet, and executives hope expanding workforce strategies and new technology will blunt any impact.”
  • Fierce Healthcare relates,
    • “Nonprofit health systems AdventHealth and Intermountain Health announced plans Tuesday to bring Denver-area hospitals and ambulatory sites under a new, to-be-formed joint venture. 
    • “The pair have signed a letter of intent and expect to have a definitive agreement in hand “in the coming weeks” as they pursue an early 2027 close. 
    • “The proposed entity would comprise eight hospitals—five from AdventHealth and three from Intermountain—as well as “dozens” of their affiliated medical practices, clinics, urgent care and emergency centers. These represent the entirety of AdventHealth’s presence in the area, and all but one of Intermountain’s local hospitals (Intermountain Health Saint Joseph Hospital, in Denver, being the exception).”
  • and 
    • “Cardinal Health is pursuing two tuck-in acquisitions to expand its home care business.
    • “The pharmaceuticals and specialty products distributor announced on Monday it had agreed to buy AdaptHealth Corp’s diabetes health business unit and medical supply provider Strive Medical in separate deals worth $360 million.
    • “The deals will accelerate Cardinal Health’s at-home solutions’ growth strategy, the company said.”
  • and
    • “Amazon Pharmacy is collaborating with digital prescription platform eNAvvi to provide clinicians with real-time medication information and delivery options through its e-prescribing workflow.
    • “The partnership allows providers to see current pricing and stock for prescriptions, including cash pricing versus estimated insurance copays, and shows how quickly medications will reach patients, the companies said. The goal of the partnership is to support medication adherence and increase access for patients, especially for those in “pharmacy deserts.”
    • “eNavvi CEO Simon Chang said in a statement the collaboration “fundamentally changes what physicians can see and do at the moment of prescribing.”” 
  • The Wall Street Journal tells us,
    • “[The Swiss drug maker] Novartis returned to sales growth in the second quarter, reporting net sales of $14.41 billion.
    • “Core operating profit for Novartis was flat at $5.94 billion, beating analyst expectations of $5.31 billion.
    • “Novartis expects core operating profit to decline by a low single-digit percentage this year as it faces the worst patent cliff in its history.”
  • Healthcare Dive informs us,
    • “As employers grapple with worker demand for GLP-1 drugs for weight loss, 1 in 5 employers recommend employees use their FSA, HSA or integrated HRA to acquire them, according to new research from the International Foundation of Employee Benefit Plans.
    • “While most employers don’t cover GLP-1s for weight loss, many try to support workers in other ways, said Carey Wooton, associate vice president of education at the International Foundation; nearly three-quarters provide disease management and case management, more than 6 in 10 offer nutritional counseling, and a similar share cover bariatric surgery.
    • “Cost remains a major impediment to coverage. GLP-1s for weight loss represented 11.4% of annual claims for corporations in 2025, up from 6.9% in 2023, the report found.”
  • Alan Fein, writing in his Drug Channels blog, discusses “2025 Gross-to-Net Realities at Eight Top Drugmakers: The Net Pricing Drug Channel Emerges.”
  • MedTech Dive lets us know,
    • “Medtronic on Tuesday said it has developed an application for its Hugo surgical robot that enables the use of artificial intelligence to support decision-making during procedures.
    • “The Touch Surgery Aide platform incorporates Nvidia’s computing infrastructure and runs Medtronic’s AI application, called Instrument Exit Point, or IEP. The application has received Food and Drug Administration clearance, Medtronic said.
    • “Medtronic will offer an early look at the new platform this week at the Society of Robotic Surgery meeting in Florida.”

Monday update

David Ermer–Congress, FDA, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • House Majority Leader Stephen Scalise lets us know,
    • On Tuesday, [July 21] the House will meet at 10:00 a.m. for morning hour and noon for legislative business. First votes expected: 1:30 p.m. Last votes expected: 8:30 p.m. * * *
    • Legislation Considered Pursuant to a Rule:
    • Begin Consideration of H.R. 8800 – National Defense Authorization Act for Fiscal Year 2027 (Sponsored by Rep. Rogers (AL) / Armed Services Committee)
    • H.R. 6955 – Main Street Capital Access Act (Sponsored by Rep. Hill / Financial Services Committee)
    • H.R. 9770 – Continuing Appropriations Act, 2027 (Sponsored by Rep. Cole / Appropriations Committee)
  • Beckers Hospital Review reports,
    • “TrumpRx, the federal direct-to-consumer drug discount website President Donald Trump launched Feb. 5, reaches its six-month mark Aug. 5. The site has grown from 40 branded drugs at launch to 92 in July, with more than 600 generics added in May. But that catalog still covers fewer than 12% of the more than 800 brand-name drugs made by the 17 manufacturers that signed most-favored-nation pricing deals with the administration, according to an NPR analysis of an FDA drug database published July 16.” * * *
    • “Health policy researchers told NPR that TrumpRx is most useful for uninsured and underinsured cash-paying patients, particularly those seeking fertility treatment or obesity medications that insurance frequently excludes. That is not the majority of prescription drug users. Insured patients are often better off checking their copay first, a caveat TrumpRx displays on the site.”
  • Beckers Payer Issues adds,
    • “Basing Medicaid drug prices on what other wealthy countries pay could save 47 states and the District of Columbia a combined $8.6 billion — about 35% of net spending on the drugs studied — according to research published July 15 in JAMA.
    • “The analysis, led by Thomas Hwang, MD, of Boston-based Brigham and Women’s Hospital, modeled the CMS Generating Cost Reductions for US Medicaid, or GENEROUS, model
    • “Under most-favored-nation pricing, drugmakers give participating state Medicaid programs added rebates whenever Medicaid’s net price surpasses the price paid abroad. 
    • “CMS announced the voluntary model in November 2025 and launched it in January. It will run five years, and 17 pharmaceutical companies had agreed to participate, as of May, in exchange for protection from pharmaceutical tariffs.”
  • Per a Government Accountability Office news release,
    • “The Office of Personnel Management has undergone significant workforce changes in the last 2 years.
    • “Between December 2024 and March 2026:
      • OPM’s staff decreased by 35%
      • The agency eliminated 10 offices
      • 57% of employees who left OPM had 11 or more years of service—representing a loss of institutional knowledge
    • “These changes risk worsening pre-existing skills gaps we previously recommended OPM address. In addition, the OPM Office of the Inspector General identified the agency’s workforce reduction as a top management challenge for 2026, citing immediate gaps in operational capacity.”
  • A guest author, Kevin Hennecken (LinkedIn link), added a post (OPM link) to the OPM Director’s Secrets of OPM blog. He discusses the Tech Force that OPM is developing under the Dirctor’s leadership.

From the Food and Drug Administration front,

  • The Washington Post reports,
    • “The Food and Drug Administration said Sunday that a laboratory finding showing cyclospora contamination in a sample of shredded iceberg lettuce supplied by Taylor Farms de Mexico was a false positive. 
    • “But the agency did not back away from its conclusion that the company remains linked to a multistate outbreak of cyclosporiasis through its traceback investigation. 
    • “FDA’s traceback investigation and outbreak data continue to converge on shredded iceberg lettuce from Taylor Farms locations in central Mexico,” the agency said on social media Monday afternoon. It said there was “overwhelming epidemiological data” to support the voluntary recall.” * * *
    • “Federal and state investigators continue to examine thousands cases of cyclosporiasis nationwide. Michigan on Monday reported more than6,000 cases.
    • “It may not be just Taco Bell, it may not be just Taylor Farms, it may not be just lettuce,” said Barbara Kowalcyk, director of George Washington University’s Institute for Food Safety and Nutrition Security. “Lots of products carry the risk of being contaminated with cyclospora.”
    • “Other products could still be implicated, Kowalcyk said. “Next week it could be something else. It could be blueberries or raspberries or basil… or a food vehicle that we haven’t identified as a way of transmitting this pathogen,” she said. “The bottom line is this investigation is not over. It’s not just Taco Bell. It’s probably not just iceberg lettuce.”
  • The New York Times adds,
    • “The leading suspect, it seemed, was the cilantro.
    • “Weeks before an outbreak of cyclosporiasis, now traced at least in part to iceberg lettuce, laid low thousands of Americans this summer, the New York City Health Department investigated a smaller outbreak. Testing labs and doctors notified the city that people were coming down with the intestinal illness, which is caused by a parasite and can result in explosive diarrhea and other types of gastric distress.
    • “The New York investigation back in April — one of multiple case clusters the city’s disease detectives have pursued this year — led to cilantro.
    • “But how exactly do health authorities figure out how people got sick?
    • “City officials shared details of the cilantro case with The New York Times. The city’s work is only one link in a chain that also involves state and federal disease surveillance efforts, but it helps illustrate how complicated it can be to pinpoint sources of contamination in a global food-supply system. The C.D.C. says it is continuing to investigate cyclosporiasis cases unrelated to the iceberg lettuce contamination.
    • “So far this year, 442 cases of cyclosporiasis have been diagnosed in the city — far above the average of 216 cases for an entire year during the period 2019 to 2024.”
  • MedTech Dive relates,
    • “Resmed has contacted customers about a ventilator issue linked to five serious injuries, the Food and Drug Administration said Wednesday.
    • “A subset of Astral 100 and Astral 150 ventilators can inadvertently enter a fail-safe state and stop delivering therapy, creating a risk of serious injury or death.
    • Resmed informed customers of the issue on June 25, asking them to continue using the devices with precautions. The FDA shared the message in an early alert notification last week.

No Surprises Act News

  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services released guidance July 17 on new remittance advice remark codes required for use following updates to the No Surprises Act independent dispute resolution process. RARCs are standardized codes that convey information about claims processing. The guidance specifies circumstances in which group health plans and health insurance issuers offering group or individual health insurance coverage must use each RARC and technical instructions to facilitate usage. CMS said that plans and issuers can continue to use claim adjustment reason codes they consider most appropriate for any claim adjustment. The RARCs specified apply for items and services furnished on or after Jan. 1, 2027.”

From the judicial front,

  • Bloomberg Law reports,
    • “Anthropic PBC and a group of authors received final approval Monday of their $1.5 billion settlement to end a copyright class action over the AI company’s downloading of millions of pirated books, $122 million of which will go to the authors’ attorneys and litigation costs.
    • “The pact is the largest copyright class action settlement in US history and one of the first deals in the dozens of similar lawsuits pending against AI giants including OpenAI Inc., Meta Platforms Inc., and Google. It provides about $3,100 per author of more than 480,000 works Anthropic downloaded from pirate libraries Library Genesis and Pirate Library Mirror.
    • “As of April, claims for 440,490 of the works have been filed.
    • “The deal “provides meaningful relief” to the authors and publishers given the potential range of relief, “especially since further litigation would likely be complex, expensive, lengthy, and risky,” said Judge Araceli Martinez-Olguin of the US District Court for the Northern District of California.
    • “Success at trial was not assured, and a loss would have left the Class with no recourse.”

From the public health and medical / Rx research front,

  • Cardiovascular Business reports,
    • “More than 56% of U.S. adults between the ages of 30 to 79 years old are now eligible to start undergoing statins, according to new findings published in JAMA.
    • “Those numbers are based on the new dyslipidemia guidelines published in March by the American College of Cardiology, American Heart Association and several other leading medical societies.[2] The 2026 guidelines included several major changes, the researchers noted. The age range targeted for treatment broadened from 40–75 to 30–79, for example, and clinicians started focusing on 30-year risk instead of just 10-year risk. 
    • “What do these updates mean for patient care? According to the team’s analysis, many more patients—approximately 21.5 million—are now eligible for statins. 
    • “The shift to a longer view of cardiovascular disease risk is a sea change for doctors in counseling patients,” lead author Timothy S. Anderson, MD, a primary care physician and health quality researcher with the University of Pittsburgh School of Medicine, said in a statement. “We wanted to better understand the potential population-health effect of this shift.”
  • The American Medical Association lets us know what doctors want their patients to know about Crohn’s Disease.
    • “Crohn’s disease is a condition that can affect any part of the digestive system. While it affects people throughout their lives in different ways, more treatment options are now available. Physicians are also finding promising lifestyle adjustments to help with the disease.”
  • Health Day tells us,
    • “Higher levels of testosterone in girls during puberty are associated with mental health symptoms such as depression and anxiety.
    • “Testosterone increases were more significant than other hormonal changes, including estrogen.
    • “Hormones can impact the brain before puberty becomes physically apparent.”
  • and
    • “Heart-healthy vegetables may differ for men and women
    • “Men benefit most from legumes, while women benefit most from cruciferous vegetables, research shows
    • “Even one daily serving is linked to better health.”
  • The Wall Street Journal adds,
    • “An American Heart Association statement says drinking up to five cups of coffee a day is safe for most adults and might benefit heart health.
    • “Consuming three to five eight-ounce cups of coffee daily is linked to a lower risk of heart disease, stroke and Type 2 diabetes.
    • “The potential benefits of coffee can be diluted or eliminated by adding sugar, syrups and creamers with high saturated fat.”
  • Genetic Engineering and Biotechnology News relates,
    • “A vaccine to prevent pancreatic cancer, targeting common KRAS mutations, was found to be safe and stimulated KRAS-specific T-cell responses in 90% of study participants who were at high risk of developing pancreatic ductal adenocarcinoma (PDAC), according to Phase I clinical trial results. After a median follow-up of 16.5 months, none of the participants developed pancreatic cancer, and some of the precancerous lesions shrank or stopped growing. “The study represents the first proof of concept for the use of vaccines for interception of pancreatic cancer in human patients.
    • “The findings are published in Cancer Discovery, in the paper, “First-in-human Testing of a Mutant KRAS Vaccine for Pancreatic Cancer Interception in High-risk Cohorts.”

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

  • AHIP reports today that “Health Plans Are on Track to Streamline Prior Authorization.”
  • Beckers Payer Issues introduces the leader of the BCBS affiliate in every state and five AI execs driving health insurers’ strategies
  • Healio relates,
    • “Variation in facility fees was linked to significant differences in cost of cardiology services with major national insurers, according to a study published in JAMA Network Open.
    • “Facility fees varied by nearly $30,000 for certain cardiology procedures, with UnitedHealthcare and Blue Cross Blue Shield having the highest facility prices and Aetna consistently having the lowest, researchers reported.”
  • BioPharma Dive tells us,
    • “Nearly four times as many Americans are taking a GLP-1 weight loss drug now compared to two years ago. But about 20% still aren’t using an FDA-approved medicine, despite efforts to curb compounded copycats, according to a recent Gallup survey. The number could be even higher. Another 12% weren’t sure if they were using a brand-name medication.
  • and
    • “Tempus AI said Monday it has agreed to buy Personalis for $1.5 billion. 
    • “Fremont, California-based Personalis makes a molecular residual disease test for cancer. Tempus expects the acquisition will allow it to better support patients around cancer diagnostics, treatment selection, recurrence and monitoring. 
    • “The planned purchase follows recent interest in blood-based cancer tests across the medtech industry. Abbott in March closed its $21 billion purchase of Exact Sciences, Guardant’s colon cancer blood test received UnitedHealth coverage, and Freenome recently shared results of a pivotal study of its blood-based screening for colorectal cancer.”
  • STAT News adds,
    • “It’s officially a trend. For the third time in nine months, a pharma company has announced that it is assembling the largest AI supercomputer in the life sciences industry. This time, it is Bristol Myers Squibb.” * * *
    • “The Princeton, N.J.-based company’s move to own its AI infrastructure, announced on Monday, is the latest in a string of pharma bets on AI data centers. In October 2025, Eli Lilly announced it was building pharma’s largest AI data center with over 1,000 of what was then NVIDIA’s latest processors. In March, Roche announced it had the “greatest announced GPU footprint available to a pharmaceutical company” with 2,176 processors on its premises in the U.S. and Europe, plus more available in the cloud for a total of over 3,500 processors. Now BMS says it is increasing its AI computing capacity more than tenfold to become the “most powerful” AI buildout in pharma, though executives declined to specify a number of processors.”
  • Cardiovascular News informs us,
    • “Heartflow had a busy four days at SCCT2026, the annual meeting of the Society of Cardiovascular ComputedTomography (SCCT). The company’s advanced artificial intelligence (AI) technologies were at the heart of multiple presentations, for example, and it officially launched a new staging tool based on total plaque volume (TPV) calculations.
    • “Heartflow’s AI software turns coronary CT angiography (CCTA) images into personalized 3D models of the heart. With tools like Plaque Analysis and Roadmap Analysis, the company’s Heartflow One platform helps care teams explore, evaluate and manage a patient’s coronary health. 
    • “Heartflow technology was featured in eight different clinical studies presented at SCCT2026, providing an in-depth look at the cardiovascular health of more than 36,000 adult patients. DECIDE, for example, focused on registry data from nearly 12,000 symptomatic patients with zero coronary artery calcium (CAC) scores. These individuals would have typically been categorized as zero-risk patients, but researchers found that approximately one-half of the cohort actually did present with non-calcified plaques that were missed by the original CAC score.
    • “While coronary calcium scoring has been a helpful foundational tool, relying on calcium scoring alone leaves a diagnostic gap for clinicians, particularly regarding high-risk non-calcified plaque,” investigator Vincent L. Sorrell, MD, co-director of the Cardiovascular Research Priority Area at the Gill Heart and Vascular Institute at University of Kentucky HealthCare, said in a statement. “The DECIDE data demonstrate that Heartflow’s TPV-based staging unmasks important cardiovascular disease in over half of symptomatic patients who present with a calcium score of zero. This enhances our ability to accurately identify at-risk individuals and optimize preventive management based on a more precise understanding of their actual disease burden.”