Thursday report

Rx coverage

Thursday report

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

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The House Budget Committee July 16 passed a budget resolution by a 20-14 vote along party lines during a markup, paving the way for a new reconciliation bill that is narrowly focused on providing additional funding for defense, farm aid and election-related provisions. The budget resolution instructs the House Committees on Administration, Agriculture, Armed Services, and Intelligence to draft legislation by Sept. 11 that provides up to $95 billion in funding. The resolution does not include a request for committees to offset the increase in spending, and no committees with a healthcare jurisdiction received instructions. The budget resolution could be considered by the full House next week. The House and Senate must pass an identical budget resolution before moving forward with a reconciliation bill.”
  • Roll Call offers more detailed on this budget resolution process here.
  • STAT News relates,
    • “A Senate vote to halt a Medicare pilot that uses artificial intelligence to approve or deny care failed along party lines on Thursday.
    • “Republicans voted to block consideration of a Democratic-led measure, which would have stopped the Trump administration from employing prior authorization in original Medicare, where the practice is rarely allowed. The vote was 46 to 50.
    • “The White House had pushed back against the Democratic bill. Medicare officials gave a handout to lawmakers’ offices on Tuesday outlining what they say are the benefits of the test, known as WISeR.”
  • Per a Senate news release,
    • “U.S. Senators Bill Cassidy, M.D. (R-LA), Chairman of the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee, and Bernie Sanders (I-VT), Ranking Member of the HELP Committee, applaud the unanimous vote in the Senate to pass the Older Americans Act (OAA). The bill supports the health, independence and dignity of older adults across the nation.” * * *
    • “The bipartisan reauthorization of the Older American Act marks a major step forward in strengthening the nation’s commitment to older adults. The legislation expands critical nutrition, health and community-based services. It reauthorizes OAA programs through fiscal year 2030 and makes improvements to better support family caregivers and direct care workers, Tribal seniors and those with disabilities in their communities.”
  • Per a House of Representatives news release,
    • “Large hospital systems and insurance companies will be required to be more transparent about their prices and financing practices while seniors and patients living in rural and underserved communities will have more access to better health care under [a boatload of] legislation approved by the Ways and Means Committee. Among the policies advanced by the Committee are reforms that will force health insurers and providers to be more open and honest about the cost of care before a patient undergoes treatment. Insurance companies that provide Medicare Advantage plans will also be required to disclose more information about their companies’ finances – including revenues and administrative spending – provide clearer guidelines for how they utilize the prior authorization process, and update and streamline that process to ensure seniors get timely access to care.
    • “In addition to ensuring patients have the information they need to make more informed health care decisions, the Committee also approved legislation to expand and protect access to care in rural and underserved communities – including remote patient monitoring services and anesthesia services – as well as legislation to provide long-term care sooner for the sickest patients who need it. For seniors in nursing homes, legislation approved by the Committee will ensure essential caregivers, like a family member, can enter and provide care – even during a designated emergency when other visitation rights might be suspended.”
  • The Centers for Medicare and Medicaid Services discusses the steps that agency is taking to strengthen Original Medicare and further announced
    • “On July 16, 2026, the Centers for Medicare & Medicaid Services (CMS) issued program guidancethat provides interested parties with detailed processes and requirements for manufacturer effectuation of the maximum fair price (MFP) in 2028. Sections 11001 and 11002 of the Inflation Reduction Act of 2022 (IRA) (P.L. 117-169) establish the Medicare Drug Price Negotiation Program (hereinafter the “Negotiation Program”) to negotiate MFPs for certain high expenditure, single source drugs and biological products. The program’s requirements are described in sections 1191 through 1198 of the Social Security Act (hereinafter “the Act”), as added by sections 11001 and 11002 of the IRA and subsequently amended.
    • “This draft guidance sets forth policies regarding manufacturer effectuation of the MFP in 2028 for selected drugs payable under Part B and/or covered under Part D. The Medicare Drug Price Negotiation Program: Final Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price in 2026, 2027, and 2028(“final guidance for initial price applicability year 2028”) established the MFP effectuation policies for 2026, 2027, and 2028 for selected drugs covered under Part D and such policies currently remain in effect. When issued later this year, the final guidance will supersede for 2028 only the sections of the final guidance for initial price applicability year 2028 with respect to MFP effectuation for selected drugs covered under Part D that are included and updated herein.”  
  • The American Hospital Association News adds,
    • “The Centers for Medicare & Medicaid Services July 16 announced nationwide implementation of a new risk-based survey review process for high-performing nursing homes. CMS pilot tested the RBS process in more than 100 facilities in 22 states beginning in 2023. The initiative includes the addition of an icon on higher performing facilities in CMS’ Care Compare tool. CMS said the approach would reduce time required and staff members needed to conduct standard recertification surveys at higher performing facilities. All nursing homes will continue being surveyed at least every 15 months. While the RBS process would be available to all qualifying nursing homes, state agencies and CMS may still opt to use the traditional long-term care survey process based on concerns regarding residents’ health and safety, such as complaint reports, CMS said.  
    • “Approximately 12% of all nursing facilities will initially qualify for the new risk-based survey. To qualify, a nursing home must meet criteria quarterly, including a five-star overall rating on the Care Compare website, accurate data submission to CMS, zero citations indicating harm or substandard care quality in the previous survey cycle, and no recent ownership changes. CMS said that survey implementation is scheduled to begin in September following state agency training. Designations for high-performing facilities in the Care Compare tool are also expected to begin in September.”
  • Per a Health and Human Services Department news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today joined U.S. Department of Agriculture (USDA) Secretary Brooke Rollins at Tampa General Hospital to celebrate the hospital’s signing of the Trump Administration’s Dietary Guidelines for Americans.” * * *
    • “Secretary Kennedy also toured Tampa General Hospital’s cafeteria, where Chef Zakarian redesigned the menu in 2025 around the principle that food is medicine.”
  • Federal News Network tells us,
    • “Dozens of House and Senate Democrats are demanding answers from the Trump administration on its implementation of Schedule Policy/Career — a move that’s already affecting thousands of career federal employees and may be poised for expansion.
    • “A letter sent to the White House on Wednesday, obtained exclusively by Federal News Network, called for details about exactly how many positions were reclassified last month, and whether the administration plans to add to the list of those stripped of their civil service protections.
    • “Lawmakers argued that the White House has not provided enough information on who has been affected and why, compounding their concerns about Schedule Policy/Career. Signed by 53 Democrats, the letter launches an inquiry into the reach and impact of the new employment classification, while warning that the policy will politicize and undermine the federal workforce.” * * *
    • “The White House is facing a July 31 deadline to respond to the congressional demands. The White House and the Office of Personnel Management did not immediately respond to Federal News Network’s requests for comment.”
  • Meanwhile, OPM Director Scott Kupor added a post to his Secrets of OPM blog about GPPA.
    • “Then-actor Ronald Reagan immortalized the phrase – “Just win one for the Gipper” – in his 1940 portrayal of George Gipp, a young Notre Dame football player who died in 1920 after a big Notre Dame win. The phrase was Gipp’s dying words to his legendary coach Knute Rockne.
    • “In the Reagan movie, Rockne recounts the story of Gipp’s heroism and selflessness to rile up his team at halftime during a tied game against Army. Notre Dame prevailed over Army and the player who scores the winning touchdown proudly proclaims: “That’s one for the Gipper.”
    • “Reagan later popularized the phrase as part of his various political campaigns, culminating with his 1988 Republican National Convention speech endorsing former Vice President George Bush: “But, George, just one personal request: Go out there and win one for the Gipper.”
    • “Ok, back to reality.
    • “This week, OPM launched a new, modernized version the Guide to Processing Personnel Actions (affectionately known as “GPPA”). And, truth be told, I’ve been waiting with bated breath to release this post – if only to bastardize Gipp’s famous words.”
  • Tammy Flanagan, writing in Govexec, explains “why Social Security’s uncertainty is becoming a federal workforce issue.”
    • A bipartisan proposal would force Congress to confront Social Security’s long-term finances, with significant implications for retirement planning under FERS.
  • The Wall Street Journal reports,
    • “The federal government is cracking down on companies that provide ketamine for consumers to take at home, as concerns grow about misuse, adverse effects and deaths.  
    • “The Drug Enforcement Administration has ongoing multiple investigations into “bad actors” prescribing the powerful mind-altering drug online, according to a person familiar with the probes.
    • ‘In late June, the Food and Drug Administration sent warning letters to 14 online marketers citing “significant violations” and ordering them to stop selling their ketamine products. 
    • “FDA has identified significant risks associated with unapproved ketamine products, especially in the absence of appropriate medical supervision,” the agency wrote in the letters to marketers whose websites include ketaminetroches.com and legitketaminesuppliers.com. “The easy availability of unapproved and misbranded ketamine products via the internet puts U.S. consumers at risk for serious adverse events.”
  • FYI, according to the Journal of Accountancy, the Internal Revenue Service, effective July 1, 2026, released
    • “Announcement 2026-11 modified Notice 2026-10. It revised the optional standard mileage rates for computing the deductible costs of operating an automobile for business, medical, or moving expense purposes and for determining the reimbursed amount of these expenses that is deemed substantiated.
    • “The American Automobile Association reported that the average price for regular gasoline was $2.819 a gallon on Jan. 8, and $3.890 on July 15, an increase of 38%.
    • “The revised standard mileage rates, effective July 1, are: 76 cents per mile for business, an increase from 72.5 cents, and 23.5 cents per mile for medical and moving purposes, up from 20.5 cents per mile for each. The mileage rate that applies to the deduction for charitable contributions is fixed under Sec. 170(i) of the Internal Revenue Code at 14 cents per mile.
    • “All other provisions of Notice 2026-10 remain in effect.”

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has approved enlicitide, a new oral PCSK9 inhibitor from Merck, to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia. The approval covers patients presenting with heterozygous familial hypercholesterolemia (HeFH) as well. 
    • “This is first time an oral PCSK9 inhibitor has been approved by the FDA to lower LDL-C. All PCSK9 inhibitors on the market today are injectable—an oral option that does not require needles could make a significant impact on patient care.
    • ‘Merck is selling enlicitide under the brand name Lipfendra. Patients take a 20-mg tablet of the drug once per day in addition to following a heart-healthy diet and regularly exercising. 
    • “By harnessing the innovative science of PCSK9 inhibitors and novel macrocyclic peptide technology, Lipfendra was designed to significantly lower LDL-C in the form of a convenient once-daily pill,” Dean Y. Li, MD, PhD, president of Merck Research Laboratories, said in a statement. “This is a pivotal moment as we bring the first U.S. FDA-approved oral PCSK9 inhibitor to adults with high LDL-C, offering patients an important new option. We’re proud of our work with regulators on this rigorous and efficient review process.” 
  • The Washington Post adds,
    • “These [oral PCSK9 inhibitor] drugs are an important line of defense for people whose cholesterol won’t come down enough with a statin alone. 
    • “Some patients do not respond well to a statin, which is the standard, low-cost treatment for high cholesterol. In many cases that is because of a condition called hypercholesterolemia, an inherited disorder. 
    • “Other patients may not be able to tolerate the side effects of a statin, which can cause muscle pain, weakness and headaches, as well as gastrointestinal issues.
    • “There are some patients who can’t tolerate statins, or they can’t tolerate statins at a high enough dose to achieve their LDL goals,” Michos said. “The reality is there’s a huge unmet need — lots of patients out there who are not at their goal.”
    • “And for people who don’t want to inject themselves, the new pill presents an alternative.”
  • The article delves into related topics, like potential side effects.
  • Bloomberg notes,
    • “Merck priced the drug at $10.50 a day [or approximately $3800 annually], a level that should provide broad access regardless of insurance, including the majority of Medicare patients with coinsurance requirements, spokesperson Julie Cunningham said in an email.
    • “The medicine will likely have other competition. AstraZeneca Plc is also developing a cholesterol pill, with studies showing it halved levels of so-called bad LDL cholesterol in a mid-stage trial last year.”
  • The Lupus Foundation tells us,
    • “The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to EMD Serono’s investigational drug, enpatoran, for the treatment of systemic lupus erythematosus (SLE) in those with active cutaneous skin manifestations. This designation is given only to therapies that show early promise for serious conditions and signals the FDA’s commitment to speeding up their development and review. This announcement marks a significant milestone for the lupus community, as there are currently no approved targeted therapies specifically for lupus skin manifestations.

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Investigators have linked shredded iceberg lettuce supplied to Taco Bell restaurants by Taylor Farms [based in Salinas, Calif.] as a potential source of contamination in the outbreak of a parasitic illness that has sickened thousands in United States, according to two individuals familiar with the investigation.
    • “The two spoke on the condition of anonymity to share details of the ongoing investigation.
    • “This summer’s outbreak of cyclosporiasis has been largely concentrated in southeastern Michigan, where more than 4,300 cases have been reported and at least 100 people have been hospitalized as of Thursday.”
  • FEHBlog observation: Taylor Farms sells its prepackaged salad products in Dripping Springs Texas where the FEHBlog lives so he expects that its products are widely offered. Stay clear of pre-packaged lettuce. Heads of lettuce are less expensive anyway.
  • The New York Times explains
    • “The New York Times publishes maps that track air quality and wildfire smoke nationwide. Fire.AirNow.Gov also show the air quality index in a given area, which can help you determine if you should limit the amount of time you spend outdoors [due principally to the Canadian wildfires].
    • “Air Quality Index values above 100 mean that outdoor air may be unsafe for people who are at higher risk of getting sick. (More on that below.) The Centers for Disease Control and Prevention has said that some people could experience health effects at levels between 151 and 200, and that these might be more serious for high-risk people. Levels over 200 are considered “very unhealthy” for anyone. An AQI between 301 and 500 means pollution levels are hazardous, and even more likely to cause health issues.”
  • The article offers additional information about protecting your health in smoky conditions.
  • Health Day relates,
    • “Obesity prevalence has risen substantially since 1999 and now affects more than 40 percent of U.S. adults and 20 percent of U.S. youths, according to a study published online July 6 in Circulation.
    • “Anum S. Minhas, M.D., from Johns Hopkins University in Baltimore, and colleagues used data from a median of 8,687 participants from each cycle of the National Health and Nutrition Examination Survey between 1999 and 2023.
    • “The researchers found significant increases in the prevalence of obesity (30 to 41 percent), severe obesity (5 to 10 percent), and abdominal obesity (48 to 61 percent) among adults (aged 20 years and older). These increases were seen for all adult age groups; adults 40 to 59 years old had the highest prevalence of overall obesity at the end of the study period. Women had higher end-point prevalence estimates than men for severe obesity (13 versus 7 percent) and abdominal obesity (70 versus 51 percent). Across survey cycles, non-Hispanic Black adults consistently had the highest prevalence of obesity, severe obesity, and abdominal obesity versus other race and ethnicity groups. Similar trends were seen in youths (younger than 20 years), with increases in prevalence estimates of obesity (15 to 22 percent), severe obesity (1 to 3 percent), and abdominal obesity (21 to 27 percent) during the study period.”
  • MedPage Today tells us,
    • :Epidural analgesia during labor was not linked with neonatal neurological morbidity or other adverse neonatal and pediatric outcomes.
    • “Epidurals are the most effective pain relief in labor but their impact on neonatal health remains understudied.
    • “This study was among Scottish women, who opt for epidural analgesia at far lower rates than U.S. women.”
  • Healio informs us,
    • “The weekend warrior-style exercise pattern may effectively lower risk for development of cardiometabolic disease among people with hypertension, according to a study published in the Journal of the American Heart Association.
    • “Achieving the majority of guideline-recommended physical activity over the weekend reduced risk for first cardiometabolic disease to a similar level vs. those who reach their goal throughout the week, researchers reported.”
  • and
    • “A highly sensitive blood test can detect signs of pancreatic cancer that standard methods often miss, according to results of a prospective cohort study.
    • “Digital droplet polymerase chain reaction (ddPCR) analysis performed upon diagnosis of localized disease detected KRAS-mutant circulating tumor DNA (ctDNA) nearly four times more often than more widely used next-generation sequencing, with results strongly predicting survival.
    • “Administration of ddPCR after chemotherapy or surgery also detected traces of ctDNA with the key genetic mutation at considerably higher rates, suggesting it more effectively identifies patients with residual disease who are at greater risk for recurrence.”
  • Cardiovascular Business points out,
    • “As transcatheter aortic valve replacement (TAVR) gains more and more momentum as a go-to treatment option, many patients with severe aortic stenosis are still missing out on the procedure. Can advanced artificial intelligence (AI)algorithms make a difference? 
    • “That was the question behind ALERT, a clinical trial presented at ACC.26 and simultaneously published in JACC.[1] Lead author Wayne B. Batchelor, MD, a veteran interventional cardiologist and president of Inova’s medicine service line, and colleagues aimed to learn if AI software from Chicago-based Tempus could be used to alert clinicians when suspicious findings turn up on a patient’s echocardiography results. 
    • “Batchelor is participating in an upcoming webinar to discuss ALERT at length and explore the potential impact AI-enabled clinician alerts can have on patient care.” * * *
    • “Cardiovascular Business and Medtronic are hosting the free webinar on Wednesday, July 22, at 6 p.m. ET. A live Q&A session will follow the presentation.
    • “Click here to register or view additional details.”
  • and
    • “A surgeon in Michigan has performed the world’s first single-port robotic mitral valve repair, highlighting a new minimally invasive treatment option for leaky mitral valves. 
    • “The surgery typically requires a five-port technique. This new single-port approach, however, saves patients a lot of pain and helps them recover much more quickly. Rakesh M. Suri, MD, DPhil, regional director of cardiac surgery robotics and innovation at Corewell Health William Beaumont University Hospital, performed the procedure.
    • “For two decades, we’ve worked to make heart surgery safer and less invasive,” Suri said in a statement. “With single-port robotic surgery, we can now repair the heart through one small robotic port and a tiny access incision—streamlining the procedure, reducing complexity and enhancing safety—ultimately delivering a better experience and better outcomes for patients.”
    • “The patient undergoing this historic procedure was Patrick O’Brien, a 60-year-old male and longtime Corewell Health patient.”  
  • Per BioPharma Dive,
    • “Veradermics on Wednesday delivered another research win for its experimental baldness drug, showing it can help women with mild-to-moderate pattern hair loss.
    • “The pill, known as VDPHL01, is an extended-release version of minoxidil, sold for decades under the brand name Rogaine. Veradermics theorized that prolonging exposure to the medicine would allow more consistent and intense hair growth while avoiding spikes of drug concentration that can cause side effects.
    • “The new Phase 2 study followed 28 women who took the pill either once or twice a day. Results across both groups were similar, with a mean increase of about 23 hairs per square centimeter after six months of treatment. Importantly, a majority of participants and researchers reported seeing improvement at the earliest check-in point of two months, Veradermics said.” 

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

  • The Wall Street Journal reports,
    • “UnitedHealth Group reported results well above analysts’ expectations and substantially raised its earnings projection for the year, moves likely to bolster Wall Street’s belief in the healthcare company’s financial turnaround.’ * * *
    • “The announcement comes a little more than a year after Chief Executive Officer Stephen Hemsley returned to the top job, promising major changes after a financial meltdown.
    • “For the second quarter of 2026, UnitedHealth reported net income of $5.48 billion, or $6.04 a share. That compared with net income of $3.41 billion, or $3.74 a share, a year earlier.
    • “On the back of that strength, UnitedHealth raised its guidance for full-year adjusted earnings to a range of $19.50 to $20 a share, from a prior floor of $18.25. The FactSet consensus was $18.49.
    • “It’s almost like we’re doing a reset on guidance,” said Wayne DeVeydt, UnitedHealth’s chief financial officer, in an interview. The company had been cautious about expectations after the first quarter, but now feels that the trends it saw then are durable, he said.”
  • Beckers Payer Issues adds,
    • “UnitedHealthcare is joining the choir of insurers calling for an overhaul of the No Surprises Act’s arbitration system.
    • “The IDR process is not working, certainly not as Congress intended it, and it needs to be reformed,” Dan Kueter, CEO of the insurer’s employer and individual business, said on UnitedHealth Group’s second-quarter earnings call July 16.
    • “Mr. Kueter said the independent dispute resolution process is “being exploited by select providers and select geographies,” adding about 50 basis points of incremental cost trend in 2026 and now accounting for at least 100 basis points of total commercial cost at the company.
    • “According to the insurer, upwards of 40% of claims that enter the IDR process are ineligible, and roughly 60% of arbitration cases are brought by just five entities, a concentration Mr. Kueter said marks a shift from prior years. When arbiters side with out-of-network providers, the average payout is now 11 times what Medicare would pay, with some determinations reaching 30 times Medicare rates, he said.”
  • Beckers Health IT points out,
    • “CVS Health wants to position itself as the primary data host for the Trump administration’s push on healthcare interoperability, CEO David Joyner told Politico in a July 16 interview.
    • “Mr. Joyner, who oversees a company spanning pharmacies, primary care clinics and health insurer Aetna, said fragmented data systems keep patients from making informed care decisions. He argued that opening up data access, paired with artificial intelligence, would let CVS serve as a connective layer between hospitals, pharmacies and health plans.
    • “The company’s Health100 app is central to that strategy. Mr. Joyner described it as a personal health assistant that uses AI to suggest alternatives to emergency room visits and coach patients through care decisions.
    • “Mr. Joyner’s remarks come as the Trump administration has stepped up scrutiny of health information blocking and pushed health IT developers, insurers and other industry actors toward more open data-sharing practices.
    • “Affordability is also driving the strategy. CVS Health needs to be “part of the solution as opposed to the problem,” Mr. Joyner told Politico, pointing to hospitalization utilization and drug manufacturer pricing as the largest drivers of healthcare costs ahead of the midterms.”
  • The Wall Street Journal relates,
    • “Eli Lilly LLY has struck a deal to buy mental-health-focused AtaiBeckley ATAI  for an initial $2.8 billion, continuing the drugmaker’s recent buying spree.
    • “Eli Lilly on Thursday said it would pay $6.75 a share in cash for AtaiBeckley, a 26% premium to Wednesday’s closing price of $5.36 for the New Yorkclinical-stage biopharmaceutical company.
    • “The deal also includes contingent value rights worth up to an additional $1 billion, or $2.50 a share, tied to AtaiBeckley’s pipeline of therapeutics for mental-health conditions, including psychedelic therapies such as its lead program BPL-003, which is aimed at providing relief from treatment-resistant depression, Eli Lilly said.
    • “The contingent value rights bring the total potential deal value to $3.8 billion, or $9.25 a share.”
  • Fierce Healthcare tells us,
    • “GE HealthCare and a six-hospital New York nonprofit health system have struck a 10-year, $500 million strategic partnership that will outfit the provider’s facilities with advanced imaging, AI and other technologies.
    • “The deal with Catholic Health, referred to by GE HealthCare as a Care Alliance, is among the medical technology company’s largest such partnerships to date and is expected to result in new service line expansions as well as improved care, the partners said in their Thursday morning announcement. 
    • “It’s slated to add more than 1,300 new pieces of technology across over 40 hospital and outpatient sites, about half of which will arrive within the agreement’s initial three years. The first rollouts will hit care sites “within months,” per the announcement, and include contrast-enhanced mammography, diagnostic imaging capabilities for multiple modalities and maternal-infant care monitoring tools.”
  • Beckers Hospital Review informs us,
    • “New York City-based NYU Langone Health is adding two physician practices in Palm Beach County, Fla., as the system builds a larger ambulatory care campus in West Palm Beach.
    • “NYU Langone Medical Associates—Palm Beach Gardens opened earlier this month, according to a July 15 health system news release. The practice offers internal medicine, cardiology, rheumatology, orthopedics, gynecology and gastroenterology. Three physicians are joining the location: Madina Ray, MD, relocating from NYU Langone Hospital—Brooklyn to provide rheumatologic services; Sterling McClain, DO, for gynecologic services; and Rami Elkhechen, MD, who is moving his existing South Florida sports orthopedic practice to the new site.
    • “A second location, NYU Langone Medical Associates—Boynton Beach, will open in September, offering internal medicine, urology and gynecology.
    • “With each new location, we are making it easier for patients across Palm Beach County to access the comprehensive, coordinated care they need close to home,” Oren Cahlon, MD, executive vice president, vice dean for clinical affairs and strategy, and chief clinical officer at NYU Langone, said in the release.”
  • and
    • “Drug costs are emerging as one of hospitals’ fastest-growing expense categories, outpacing labor and other nonlabor costs as organizations continue to navigate a challenging financial environment, according to Kaufman Hall’s latest “National Hospital Flash Report.”
    • “Nationally, drug expense per adjusted discharge increased 11% compared to 2023, one of the largest increases among major hospital expense categories. Drug expense per calendar day also rose 5% year over year and 25% compared to 2023, exceeding the growth rate for labor and total operating expenses.
    • “The trend is especially pronounced at the nation’s largest hospitals.”
  • and
    • “Ambulatory surgery center operator Amsurg has acquired five North Carolina-based endoscopy centers. 
    • “The newly acquired facilities are located in the eastern and central portions of the state and provide patients with a team-based approach to managing acute and  chronic gastrointestinal conditions, according to a July 14 news release. 
    • “Each of the five centers will continue providing high-quality care while benefiting from Nashville, Tenn.-based AmSurg’s operational expertise, clinical resources and growth support, according to the release.
    • “The acquisitions come just over a month after Amsurg was acquired by St. Louis-based Ascension in a deal valued at about $3.9 billion. As a condition of FTC approval, six divested Amsurg facilities are being picked up by Optum subsidiary SC Affiliates, adding to UnitedHealth’s already sizable ASC network.”
  • and
    • “Rochester, Minn.-based Mayo Clinic has deployed roughly 150 AI models across its health system, CNN reported July 16. 
    • “The tally, according to Matthew Callstrom, MD, a radiologist and medical director of the health system’s generative AI program, spans tools built with partners including Microsoft and Scale AI, drawing on Mayo Clinic’s patient records and research. 
    • “One example, a documentation tool called Record Time, was developed with Scale AI to help physicians parse patient files before visits. Alexander Ryu, MD, an internal medicine physician and vice chair of innovation for Mayo Clinic’s Department of Medicine, told the publication the tool saves him five to 30 minutes of prep time per patient by organizing records chronologically and surfacing key details.
    • “Mayo is also running a clinical trial testing whether AI can flag early-stage pancreatic cancer, a disease often not caught until it has spread.” 

Tuesday report

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

Simplicity is a virtue

From Washington, DC

  • Roll Call reports,
    • “Sen. Darline Graham took the oath of office Tuesday to fill the vacancy left by the unexpected death of her older brother, four-term Republican Sen. Lindsey Graham. The late Graham died Saturday night at age of 71 of an aortic dissection, according to preliminary findings by the D.C. medical examiner.”
  • and
    • “Speaker Mike Johnson narrowly freed the floor from another standstill Tuesday — but it’s not clear how long the good feeling will last.
    • “The House adopted a rule for floor debate in a 215-211 vote after GOP leaders won over key holdouts by promising a markup of border security legislation before the August recess and taking steps to graft a voter ID bill onto a spending measure.
    • “With such a slim majority, leadership can only afford to lose a few Republican votes for party-line measures.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is proposing transformational reforms to Medicare’s physician payment and value-based care programs that would expand accountable care, modernize physician payment, reduce administrative burden, and help shift the healthcare system’s focus from treating illness to preventing it.
    • “The proposals would make Medicare accountable care organizations (ACOs) easier to join and more rewarding to participate in, transition clinicians away from traditional Merit-based Incentive Payment System (MIPS) reporting toward more meaningful value-based care pathways, and update physician payment policies to better reflect modern clinical practice. Together, these reforms would strengthen primary care, improve patient outcomes, and support Medicare’s long-term sustainability.
    • “We’re proposing some of the most significant Medicare reforms in recent years to strengthen primary care, expand accountable care, and modernize physician payment,” said CMS Administrator Dr. Mehmet Oz. “These changes would make it easier for clinicians to focus on prevention, improve coordination for patients, and ensure Medicare rewards better outcomes rather than more services.” * * *
    • “To view the CY 2027 Physician Fee Schedule proposed rule, please visit: https://www.federalregister.gov/public-inspection/current
    • “To view the related Quality Payment Program fact sheet, please visit: https://d2g5m5leph8kam.cloudfront.net/s3fs/s3fs-public/2026-06/2027-qpp-proposed-rule-factsheet.pdf
    • “For a fact sheet on the CY 2027 Physician Fee Schedule proposed rule, please visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2027-medicare-physician-fee-schedule-proposed-rule
    • “For a fact sheet on the proposed Medicare Shared Savings Program changes in the CY 2027 PFS proposed rule, please visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2027-medicare-physician-fee-schedule-proposed-rule-cms-1848-p-medicare-shared“
  • Radiology Business adds,
    • “Physicians with greater clinical knowledge are less likely to order low-value imaging and other unnecessary healthcare services, according to new research published Monday. 
    • “These wasteful tests and treatments—such as imaging for an uncomplicated headache, which provides no benefit to the patient—continue plague the U.S. healthcare system. Each year, the country spends an estimated $100 billion on low-value services, experts write in JAMA Internal Medicine. 
    • “Researchers recently aimed to better understand how higher physician knowledge might help to curb healthcare waste.  They utilized the American Board of Internal Medicine’s Longitudinal Knowledge Assessment to measure clinician know-how, matching it against IM’s ordering of 25 different low-value services including medical imaging. 
    • “Lead author Jonathan L. Vandergrift, MS, and colleagues found a clear connection, with high-knowledge docs less likely to order unnecessary scans.”
    • “These findings suggest an important question for further study: If those who scored lower in the first year increase their knowledge, and therefore their score, over time, will they then order fewer low-value services?” Vandergrift, a senior health services researcher at the ABIM, said in a news announcement July 13. “We hope to learn more about whether the healthcare system may cut unnecessary costs through education and assessments that steer clinicians toward higher-value care that provides the most benefit to patients.”
       
  • The American Hospital Association relates,
    • “The Health Resources and Services Administration announced that 340B covered entities purchased $100 billion in outpatient drugs under the federal 340B Drug Pricing Program in calendar year 2025. This represents an approximate 22% increase from CY 2024, which had sales of about $81.4 billion. HRSA partly attributed the growth to increased shifts from inpatient to outpatient care, a rise in innovative therapies and increases in drug pricing. Of the $100 billion in CY 2025 sales, 340B hospitals accounted for nearly 87%, or about $87 billion.”
  • Per a Government Accountability Office news release,
    • “In recent years, Medicare’s spending on hospice has nearly doubled. We looked at this spending and found that the way Medicare pays for hospice care could be costing taxpayers billions more than it should. 
    • “Today’s WatchBlog post looks at our new report about inefficiencies in Medicare’s payments.”

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “The FDA has approved Sanofi’s subcutaneous Sarclisa Escena in combination with standard-of-care regimens for patients with multiple myeloma across all existing indications of the intravenous formulation, making it the first anticancer treatment administered through an on-body injector.
    • “Sarclisa Escena is administered through Sanofi’s on-body injector and is the first multiple myeloma treatment in the U.S. available through both an on-body injector and manual subcutaneous administration, according to a July 10 news release.”
  • Cure relates,
    • “The Food and Drug Administration (FDA) on July 14, 2026, granted traditional approval to Retevmo (selpercatinib) for adults and children 2 years of age and older with locally advanced or metastatic solid tumors that carry a RET gene fusion, as identified by an FDA-approved test.
    • “To be eligible, patients must have seen their cancer progress on or after prior systemic treatment, or have no satisfactory alternative treatment options available.
    • “The approval marks an upgrade from the accelerated approval Retevmo previously received for this indication — first for adult patients in 2022 and later extended to pediatric patients ages 2 and older in 2024. Traditional approval is granted when a drug’s clinical benefit has been confirmed through additional clinical evidence.”
  • MedTech Dive reports,
    • “Medtronic is removing from the market certain lots of a catheter used to place pulmonary valves, the Food and Drug Administration said in a Monday recall notice.
    • “The affected devices have an increased risk that the distal tip may detach from the delivery catheter system, requiring another procedure to remove the tip. As of May 14, Medtronic had not reported any serious injuries or deaths associated with the issue, according to the FDA notice.
    • “A Medtronic spokesperson said in an emailed statement to MedTech Dive that the problem is limited to certain delivery systems and does not involve the valve itself. Medtronic has resolved the underlying manufacturing problem, so future shipments will not be affected by the recall, the spokesperson wrote.”

From the judicial front,

  • Healthcare Dive reports,
    • “CVS Health’s Caremark has reached a settlement with the Federal Trade Commission requiring notable changes to the pharmacy benefit manager’s business practices, including that Caremark prefer the lowest-cost drugs on its standard formularies and pass through savings negotiated with drugmakers to clients.
    • “The settlement announced by the FTC on Tuesday puts to bed regulators’ allegations that Caremark preferred more expensive versions of insulin in order to increase its rebates, driving up prices for the lifesaving diabetes drug. The FTC lodged the suit against Caremark, along with fellow PBM giants Express Scripts and Optum Rx, in 2024.
    • “Express Scripts settled with the FTC in February while Optum Rx is still finalizing an agreement with the antitrust agency.”
    • “The terms of CVS’ settlement are very similar to those secured with Express Scripts. The deal prevents the drug middleman from discriminating against cheaper drugs in its standard formularies for commercial clients, and requires it to provide a standard offering to plan sponsors that doesn’t include rebates.
    • “It requires Caremark to include any purchases a patient makes through TrumpRx, President Donald Trump’s online drug marketplace, towards the deductible in certain health plans, once regulatory changes make that possible. The settlement also includes a number of transparency provisions.
    • However, the CVS deal includes a new wrinkle meant to assuage concerns that the healthcare behemoth leverages its market power to prevent independent pharmacies from working with rival pharmacy hubs, third-party companies that provide a range of digital pharmacy services.
    • “The settlement prevents CVS from foreclosing hub service providers [FEHBlog provided link], and will create a monitor to ensure its compliance, according to the FTC.”
  • Modern Healthcare reports,
    • “The U.S. Justice Department (DOJ) sent civil investigative demands to lawyers in private litigation against Claritev [formerly known as Multiplan], escalating its antitrust probe.
    • A federal judge in June 2025 rejected Claritev’s bid to dismiss the private suits, keeping the cases alive.
    • The DOJ also has a separate ongoing antitrust investigation into one of Claritev’s major insurer clients.
  • Reuters relates,
    • “A coalition of public health organizations, pediatricians and parents sued the U.S. Food and Drug Administration on Tuesday, challenging a ​new policy that allow some manufacturers to sell vapes and ‌nicotine without the legally required license.
    • “The lawsuit, filed in U.S. District Court in Maryland, targets FDA guidance issued in May. The guidance states the agency would ​not prioritize enforcement against certain unauthorized e-cigarettes and nicotine pouch ​products if the companies have marketing applications under review.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Michigan state health officials are narrowing in on lettuce as a possible culprit in the rapidly expanding explosive-diarrhea outbreak, though federal authorities say they are still working to confirm a specific food source as the cause.
    • “Donald Prater, the Food and Drug Administration’s acting deputy commissioner for food, said lettuce is one of multiple produce items under investigation as officials race to identify the outbreak’s origins.
    • “Top health officials in Michigan said bagged, prewashed salad kits could be a particular risk, based on the state’s review of cases.
    • “The early signals are telling us that lettuce does seem to be implicated,” said Dr. Natasha Bagdasarian, the state’s chief medical executive.
    • “Michigan is the hardest hit by the cyclospora parasite, with more than 3,300 cases as of Tuesday, more than double the number on Friday.”
  • The American Hospital Association News adds,
    • “The Centers for Disease Control and Prevention July 14 released an advisory on the growing cyclosporiasis cases across the U.S. The advisory said that the agency received reports of 1,645 confirmed domestic cases across 34 states and is aware of more than 5,100 cases that require further analysis for confirmation. The CDC said that of 1,645 case-patients with available information, 9% (141) were hospitalized and no patients have died. The advisory includes recommendations for clinicians on how to diagnose and treat patients with cyclosporiasis, and for facilities on how to disinfect healthcare settings. The CDC is working with the Food and Drug Administration and state and local health departments to identify the cause of the illness. The CDC said that because cyclosporiasis is often underdiagnosed and underreported, the actual total of illnesses is likely higher than what has been reported.”
  • Healio relates,
    • “Alcohol consumption and smoking were identified as the two strongest common risk factors for breast cancer and atrial fibrillation globally, according to data published in the Journal of the American Heart Association.
    • “Reducing alcohol intake and smoking behaviors to the level at which risk is smallest, nearly one-third of breast cancer cases and 12% of AF cases could be prevented, the researchers wrote.
    • “One of the most surprising aspects of our findings was how common both breast cancer and atrial fibrillation/flutter diagnoses were among women ages 55 and older in high-income regions, which highlights the influence of lifestyle,” Shu Wang, MD, PhD, director of the Breast Disease Center at Peking University People’s Hospital in Beijing, said in a press release. “This is the first study combining global data with machine learning to show the relationship between the conditions, their location across the world and the shared risk factors of these two conditions.”
  • STAT News adds,
    • “STAT’s interviews with more than 100 experts — including current and former government officials, doctors, public health advocates, substance use researchers, people in recovery, and addiction treatment leaders — identified a dozen ways the U.S. could chip away at its alcohol epidemic.” Here are the first six:
      • Screen early and often
      • “Add ‘nudges’ to health system
        • “Health systems can do their part to boost screening and treatment by adding alcohol questionnaires, including the well-validated and quick AUDIT-C test, to clinician workflows.”
      • “Get creative with funding
        • “STAT’s reporting finds that fixing the country’s alcohol epidemic will require smarter investments and clear guidance from federal health officials.”
      • “Get the word out
        • “HHS could also reinvest in public messaging about the health risks of alcohol, such as the defunct “Drink Less, Be Your Best” campaign.” 
      • “Overhaul payment 
        • “In the clinic, payment continues to be a barrier to detection and treatment of alcohol-related problems. While health care reforms in the past two decades have boosted reimbursement for mental health treatment, including substance use disorder work, physicians say parity is still not enforced well enough.”
      • “Dive into data
        • “Even without spending more on alcohol interventions, the country could use information it already has, plus a bit of cleverness, to tackle the issue.” 
  • The National Institutes of Health’s Research Matters covers the following topics in its latest post:
    • “Brain-computer device helps man speak
      • “A man unable to talk due to paralysis successfully used a brain-computer interface system at his home to speak.
      • “This technology could become a practical communication tool for people who can’t talk because of problems with their muscles.”
    • “Sleep and exercise may reduce mutation-driven inflammation 
      • “Lifestyle factors may reduce inflammation caused by some mutations in blood stem cells, according to an analysis of human and mouse data.
      • “The results suggest improving sleep and exercise may curb the health consequences of this inflammation.”
    • “Fructose and glucose trigger different brain responses
      • “Scientists found the sugars glucose and fructose affect hunger-controlling brain cells and food preferences in mice differently.
      • “The study suggests that similar nutrients can signal to the brain through distinct pathways and have different effects on appetite.”
  • MedCity News explains
    • “How AI Can Support Better Mental Health Outcomes — With Humans at the Center.
      • “Mental health care does not need to become less human to become more effective. The most effective (and responsible) path forward is one built on partnership.”
  • Genetic Engineering and Biotechnology News tells us,
    • “Researchers at University College London (UCL) Great Ormond Street Hospital for Children (GOSH) have built a new lab model of infant lungs to show why respiratory syncytial virus (RSV) makes infants so much sicker than adults, and to allow them to test new treatments. The miniature model of a baby’s airways was created using pediatric airway cells, blood vessel cells, and neutrophils (a type of white blood cell that acts as the immune system’s primary response to infection).
    • “Studies using the new model suggest that future therapies for RSV should target both the virus and its immune response to ensure babies get the best possible outcomes. Research lead Claire Smith, PhD, at UCL Great Ormond Street Institute of Child Health, said, “This model allows us to watch early immune responses unfold and study them in a human setting that reflects the infant airway. That’s something animal models often struggle to capture, especially when it comes to age-specific effects.
    • “Senior and corresponding author Smith and colleagues reported on their findings in Nature Communications in a paper titled “Neutrophil myeloperoxidase as a functional biomarker for RSV severity: implications for in vitro therapeutic screening.” In their report they concluded, “These findings identify neutrophil–epithelial interactions as a useful target for intervention and support the use of physiologically relevant human models to accelerate the development of therapies that limit immunopathology while preserving antiviral defense.”
  • BioPharma Dive informs us
    • “Detailed findings from a closely watched clinical trial hint that a new kind of drug may offer similar benefits as approved medicines in early Alzheimer’s disease, a result that could boost the outlook for a long-studied but unproven area of scientific research.
    • “The mid-stage “Celia” trial explored whether a Biogen drug codenamed BIIB080 would be any better than a placebo at slowing the mental or functional decline of Alzheimer’s patients showing early signs of cognitive impairment. Unlike in-use therapies such as Eli Lilly’s Kisunla and Biogen and Eisai’s Leqembi, which target harmful “amyloid” proteins, BIIB080 works by gumming up the genetic instructions cells use to create another Alzheimer’s-linked protein called tau.”
  • Fierce Pharma adds,
    • “Huyabio has scored a win in the largest oncology study it has undertaken in its 22 years, as its oral histone deacetylase (HDAC) inhibitor HBI-8000 has succeeded in combination with Bristol Myers Squibb’s Opdivo in a phase 3 trial of patients with advanced skin cancer.
    • “The study, which included 404 melanoma patients across 15 countries, achieved its primary endpoint, as the combo produced a clinically meaningful improvement in progression-free survival. 
    • “Those who received HBI-8000 plus Opdivo remained alive and without their disease worsening for a median of 11.7 months, compared to a median of 7.4 months for those who were given Opdivo plus placebo. The 58% improvement was deemed statistically significant.”  

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

  • The Wall Street Journal reports,
    • “HCA Healthcare lowered its 2026 financial guidance following payer mix shifts due to health insurance exchanges.
    • “The company said the payer mix shift was driven by an increase in uninsured patients who had lost coverage on health insurance exchanges.
    • “HCA estimated that the payer mix shift had an unfavorable impact on income before income taxes of about $400 million during the second quarter.” * * *
    • “The company said it anticipates adjusted Ebitda for the second quarter of roughly $4.03 billion, and revenue for the three months of about $20.23 billion. That compared with $3.85 billion and $18.61 billion a year earlier, and is below the $4.47 billion and $19.47 billion in revenue that analysts polled by FactSet had penciled in.” * * *
    • “The company said it did see positive factors during the quarter, including growth in admissions, equivalent admissions and emergency room visits, increased benefit from Medicaid Supplemental Payment Programs and improved expense trends.”
  • Beckers Hospital Review relates,
    • “Madison, Wis.-based UW Health has reached an agreement with Marshfield Medical Center-Beaver Dam (Wis.) to bring the medical center into the health system.
    • “The hospital is part of Marshfield (Wis.) Clinic Health System, which merged with Sioux Falls, S.D.-based Sanford Health in January 2025 to create a 56-hospital, nonprofit integrated system that operates as Sanford Health. 
    • “Marshfield Medical Center-Beaver Dam is an integrated medical campus that comprises a hospital, skilled nursing facility and independent senior living apartments. The hospital also runs two assisted living facilities and primary care clinics, according to a July 13 UW Health news release shared with Becker’s.” 
  • and
    • “Little Rock, Ark.-based Baptist Health acquired Magnolia (Ark.) Regional Medical Center on July 12. 
    • “With the close of the acquisition, the 25-bed facility has been rebranded as Baptist Health Medical Center-Magnolia. 
    • “Magnolia became Baptist Health’s 14th hospital and the second acquired in less than one month. On June 14, Baptist completed its acquisition of South Arkansas Regional Hospital, a 151-bed hospital based in El Dorado. 
    • “Baptist Health signed a definitive agreement to acquire the Magnolia hospital in April.” 
  • Fierce Healthcare tells us,
    • “The American Medical Association (AMA) announced Tuesday a new interoperability initiative aimed at supporting electronic prior authorizations by better connecting clinical terminology to its Current Procedural Terminology (CPT) administrative coding.
    • “The professional association said Tuesday it will be developing and deploying SNOMED CT— a structured set of descriptive terms that serve as a shared medical vocabulary for computer systems—to CPT terminology mappings. Doing so will ultimately create a foundation for “scalable automation” to streamline workflows, improve data exchange and foster more efficient and quicker prior authorization outcomes, AMA said.
    • “Moreover, it aligns with the upcoming Jan. 1, 2027 Centers for Medicare & Medicaid Services (CMS) FHIR-based prior authorization compliance deadline.”
  • Fierce Pharma informs us,
    • “Nearly a decade after spinning out its Chinese research hub to form Dizal Pharmaceutical, AstraZeneca is paying up to $1.5 billion to buy a piece of the pipeline, securing exclusive global rights for the biotech’s oral EGFR lung cancer drug Zegfrovy (sunvozertinib).
    • “The total deal value is split between $600 million in upfront payment, up to $400 million in development milestones and another $500 million tied to certain sales milestones, according to a disclosure (Chinese, PDF) to the Shanghai Stock Exchange. Dizal is also entitled to tiered, up to low-double-digit royalties based on Zegfrovy’s global sales.
    • “The deal comes about a month after Dizal detailed positive phase 3 data for Zegfrovy in first-line non-small cell lung cancer with EGFR exon 20 insertion mutations at the 2026 American Society of Clinical Oncology annual meeting.
    • “In the global Wu-Kong28 trial, Zegfrovy significantly reduced the risk of disease progression or death by 35% compared with platinum-based chemotherapy.” 
  • and
    • “Insulet’s wearable insulin patch Omnipod may be able to seamlessly control insulin delivery for patients with diabetes, but it can’t fill all mental health-related treatment gaps on its own. To broaden its network of personalized care offerings, the company is teaming up with mental health platform Calm to roll out a host of holistic “Mind in Range” resources. 
    • “Insulet and Calm’s free-to-access mindfulness tools, launched Tuesday, July 14, are specifically tailored to the diabetes community and include short meditations, a breathing exercise and a new Calm Sleep Story narrated by fashion model Lila Moss, a diabetes patient and advocate. The collaboration marks Calm’s first integrated content partnership with a medtech company and aims to “normalize conversations” around mental health care in diabetes management, while also making mindfulness “simple and accessible,” Insulet explained in a release.” 
  • Beckers Hospital Review points out,
    • “Amazon Pharmacy is collaborating with eNavvi, a digital prescribing platform, to integrate real-time medication pricing, availability and home delivery options into clinicians’ e-prescribing workflow. 
    • “The integration gives clinicians visibility into medication costs by comparing cash prices with estimated insurance copays while automatically applying eligible manufacturer discounts, according to a July 14 news release. It also provides real-time inventory information and delivery estimates, allowing providers to make prescribing decisions based on medication availability and delivery timelines.
    • “The move builds on Amazon Pharmacy’s ongoing delivery expansion, which is on track to reach 4,500 U.S. cities and towns by the end of 2026. The company has also leaned into GLP-1 access, expanding Zepbound KwikPen availability through same-day delivery earlier this year. 
  • Beckers Health IT lets us know,
    • “OpenEvidence outperformed Claude Opus 4.8, Gemini 3.1 Pro and GPT-5.5 on real-world clinical questions in a new physician-graded study, contradicting a June Nature Medicine paper that foundgeneral-purpose AI models beat specialized clinical tools.
    • “The study, posted June 27 as a preprint on arXiv, has not yet been peer-reviewed. It had 149 practicing physicians across 36 states rate AI answers to 620 real point-of-care questions drawn from OpenEvidence’s platform, plus 187 questions from the HealthBench benchmark, judging responses on accuracy, clinical utility, source quality, verifiability and completeness.
    • “OpenEvidence posted positive win margins on all five dimensions, with differences ranging from 25 to 39 percentage points over the three general-purpose models. Claude Opus 4.8 and Gemini 3.1 Pro scored near parity with each other, while GPT-5.5 recorded the lowest win rates on every axis.”
    • “The results stood in contrast to a Nature Medicine study published June 12, which found GPT-5.2, Gemini 3.1 Pro and Claude Opus 4.6 outperformed OpenEvidence and Wolters Kluwer’s UpToDate Expert AI. OpenEvidence has since asked Nature Medicine to retract that study, alleging flawed methods; the journal has pointed the company to its formal rebuttal process instead. * * *
    • “The competing results leave hospital and health system leaders with conflicting independent evidence on how general-purpose AI models compare with specialized clinical decision support tools as adoption of both accelerates.”

Monday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, No Surprises Act, Obesity, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The Wall Street Journal reports,
    • “South Carolina Gov. Henry McMaster named Darline Graham Nordone, the sister of the late Sen. Lindsey Graham of South Carolina, to serve as an interim replacement in the Senate in the aftermath of the longtime lawmaker’s death. 
    • “President Trump had told McMaster, a Republican, that an appointment of Graham Nordone “would be a fabulous tribute to Lindsey, who loved her dearly!” Graham Nordone will serve out the remainder of her late brother’s term, which ends in early January.
    • “McMaster said Graham “took care of his little sister in years long departed. It’s my honor to ask his little sister, Darline Graham, to finish his work for him now.”
    • “Graham Nordone said, “Lindsey has always been there for me, and now I will be there for him.”
  • Fierce Healthcare relates,
    • “Insurers expect to issue $759.2 million in medical loss ratio rebates this year, according to a new analysis.
    • “The report is based on data reported by payers to states and compiled by analytics firm Mark Farrah Associates. An analysis of the data from KFF projects that total rebates paid out since their 2012 launch will rise to $15.1 billion after 2026 payments are made later this year.” * * *
    • “The estimated 2026 rebate tally is the lowest since 2018, when insurers paid $706.7 million in rebates, according to the KFF report. Rebate payments peaked in 2020 at $2.5 billion.” * * *
    • “The average simple loss ratio—which does not account for taxes or quality improvements like the MLR used to calculate rebates—was 93% in 2025, meaning plans spent 93% of their premium income on claims on average.” 
  • Healthcare Dive tells us,
    • “The oversight office of the HHS said it generated about $5.6 billion in monetary impact from fighting fraud, waste and abuse in federal health programs between October and March.
    • “The HHS Office of Inspector General also said it kicked over 1,200 people and entities off federal programs and pursued enforcement actions against people accused of running sham hospices and requesting improper Medicaid payments for autism behavioral therapy services, among others.
    • “The updates, part of a report compiled every six months for Congress, outlined the Trump administration’s healthcare enforcement priorities, adding that the HHS would focus on rooting out fraud in Medicaid and Medicare Advantage.”
  • Gilsbar, an insurance brokerage, offers information about recent revisions to the IRS Form 720 which is used to pay the annual PCORI fee.

From the Food and Drug Administration front,

  • Psychdelic Alpha reports,
    • “This morning, FDA issued its final guidance on psychedelic clinical investigations and announced a September public hearing “on the potential future therapeutic use of psychedelic drugs” and an associated request for comments. (We provided a detailed breakdown of the final guidance, as well as coverage of the planned hearing, in our Pα+ article: FDA Issues Final Psychedelics Guidance, Schedules September Hearing on the Future of Psychedelic Therapies.)
    • “Then, this afternoon, HHS and VA announced that they have entered into a five-year Memorandum of Understanding (MOU) “to strengthen collaboration on the research, clinical development, and responsible deployment to veterans suffering from serious mental health conditions of potential future rapid-acting psychedelic drug products if approved by the Food & Drug Administration.”
  • The Pharmacy Times relates,
    • “The FDA approved a new starting dosage regimen for the subcutaneous formulation of lecanemab-irmb (Leqembi; Eisai, Biogen), marking the first time patients can begin treatment with home administration either by themselves or by their caregiver,
    • “Lecanemab is an amyloid beta-directed antibody that targets and removes beta-amyloid from the brain. There is no evidence that lecanemab restores or reverses lost memories or cognitive function, but it is proven to reduce both cognitive and functional decline in patients, according to the Alzheimer’s Association.” 
  • Fierce Pharma tells us,
    • “In what GSK says represents a potential way to transform treatment for patients with certain types of rectal cancer, the company’s Jemperli has met the main goal of a phase 2 trial, teeing up an application with the FDA.
    • “Interim results from the phase 2 AZUR-1 study showed a “meaningful and sustained” clinical complete response rate for Jemperli at 12 months in stage 2/3 mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer, GSK said Monday.
    • ‘Without going into specifics, GSK said its PD-1 inhibitor showed a “substantial improvement” compared to historical experience with existing treatment options. The company now plans to share the data with global health authorities, including with the FDA under an accelerated approval pathway.”  

No Surprises Act news

  • Benefits Pro reports,
    • “Federal regulators today [July 10] said they are setting up a renewal process for the organizations that help health care providers and health care payers resolve No Surprises Act billing disputes.
    • One part of the new recertification process for the No Surprises Act “independent dispute resolution entities” could involve assessments of IDR entities’ fairness.
    • “Something officials may consider when looking at an recertification application is the ability of the IDR entity to “provide rationales for payment determinations meeting regulatory requirements,” according to a new set of answers to frequently asked questions about the IDR entity recertification process.
    • “Application reviewers will also look at an entity’s ability to handle a high volume of dispute assignments quickly and the entity’s ability to handle cases “accurately in accordance with statutory and regulatory timelines,” officials say.” * * *
    • “Regulators will post a list of the entities seeking recertification each week.”
  • Fierce Healthcare relates,
    • “A payer-backed group has launched a campaign challenging a bill that would build on the No Surprises Act.
    • “The Coalition Against Surprise Medical Billing (CASMB) announced on Monday that its “six-figure” campaign urges lawmakers to reject the No Surprises Act Enforcement Act, or H.R. 4710. This legislation, they argue, would “reward the actors misusing the [independent dispute resolution] process.” * * *
    • “The ad says that the No Surprises Act was passed “with good intentions,” but that Congress should focus future efforts on closing loopholes that allow for IDR abuse.”

From the judicial front,

  • The Wall Street Journal reports,
    • “A federal appeals court revived more than 500 lawsuits that allege Tylenol and generic acetaminophen can cause attention-deficit hyperactivity disorder or autism if taken during pregnancy.
    • “The Second U.S. Circuit Court of Appeals in Manhattan ruled that a trial judge had erred by excluding expert medical witnesses, offered by the plaintiffs, who were expected to testify that there was a link between Tylenol use during pregnancy and neurodevelopmental disorders such as autism and ADHD. The 3-0 decision sends the case back to the lower court for further proceedings.”
  • Healthcare Dive relates,
    • “More insurers are filing lawsuits in an attempt to hike their Medicare Advantage quality scores after a court decision earlier this year exposed federal regulators to a new line of legal attacks.
    • “SCAN Health Plan and Alignment Healthcare both sued the CMS in D.C. district court last week, arguing regulators robbed them of higher star ratings in the privatized Medicare program.” * * *
    • “The lawsuits from SCAN and Alignment — which are both represented by the law firm Latham & Watkins — allude to larger calls for reform and cite MedPAC’s censure of the star ratings system.
    • “The Star Ratings program went off the rails years ago,” reads SCAN’s complaint. “The system is undeniably broken.”
  • Beckers Payer Issues tells us,
    • “A federal judge has dismissed with prejudice a lawsuit from Blue Cross Blue Shield of Georgia that accused medical billing company HaloMD and two physician groups of conspiring to defraud the insurer through the No Surprises Act’s arbitration process.
    • “The insurer, part of Elevance Health, alleged in May 2025 that HaloMD, Sound Physicians Emergency Medicine of Georgia and Hospitalist Medicine Physicians of Georgia submitted false attestations of dispute eligibility, flooded the independent dispute resolution system with large volumes of ineligible disputes using AI to overwhelm program safeguards, and submitted inflated payment offers, including some that exceeded the providers’ own billed charges.
    • “In his July 10 decision, Judge Thomas Thrash Jr. wrote that the court lacked jurisdiction over most of the counts and ruled that the racketeering, state-law, ERISA and deceptive trade practice claims were “collateral attacks” on the arbitration determinations. 
    • “It is highly improbable to infer from these facts that there is a vast conspiracy of providers and IDREs that have conspired to defraud the Plaintiff of millions of dollars in thousands of NSA IDR proceedings over many years,” Judge Thrash wrote. “It is highly plausible to infer that the Plaintiff engages in a consistent practice of submitting lowball offers to out-of-network providers in an effort to maximize its profits.”

From the public health and medical / Rx research front,

  • Healio reports,
    • “There are now cyclosporiasis cases in more than half of U.S. states. 
    • “The outbreak will eventually “burn” itself out even if a source is not found, an expert said.” * * *
    • “For insight into the current surge, Healio checked in with David O. Freedman, MD, FIDSA, professor emeritus of infectious diseases at the University of Alabama at Birmingham.
      • “Healio: Are all the cyclosporiasis warnings warranted or is this outbreak overhyped? 
      • “Freedman: On a national basis, for healthy people, the odds of any illness are still relatively low. Hospitalization, if ill, is extremely rare in normal hosts and care is noninvasive, involving mostly intravenous fluids and initiation of the antibiotic course. No deaths have occurred to date.
      • “The word outbreak refers to rates of illness above a normal year. On a national basis the annual average number of cases is about 3,000, which we have not reached yet, although official reports take several weeks to catch up with individual cases submitted. This is partly due to diminished CDC capacity at the national level. A small number of individual states, notably Michigan, are now reporting case numbers at the outbreak level.
      • “Healio: Can you explain why it is so important to find a source for the outbreak?
      • “Freedman: It is likely that only a portion of the total cases are the result of a single source contamination event at a farm, processing plant or distribution center. The rest of the cases will be due to the dozens of small contamination events that occur each summer in the U.S.
      • “Finding one or a few major contamination events will greatly diminish subsequent case numbers. However, it is important to remember that the incubation period from ingestion to illness is 1 to 2 weeks, so even after identification of a source, the process of withdrawing the product from the supply chain, educating the public to avoid products already in homes and waiting for incubating cases to manifest will take several weeks.
      • “Healio: Do you feel the outbreak will only continue to spread until a source for it is identified? 
      • “Freedman: Not necessarily. Outbreaks like this tend to burn themselves out as shown by the baseline seasonality that runs from May to August. Contaminated products that entered the processing chain early in the season may have been grown under different circumstances than products entering later in the season.”
  • Bloomberg Law reports
    • “New York City officials identified dozens of buildings with Legionnaires’ bacteria in Manhattan’s Upper East Side, closing in on the source of an outbreak that has infected at least 46 people and hospitalized 22.
    • “The New York City Health Department tested the cooling towers of 183 buildings in neighborhoods encompassed by three zip codes — 10028, 10128 and 10075 — that are among the city’s wealthiest and most densely populated. Of the 31 with signs of bacterial contamination, 19 already have been cleaned, officials said on a call with reporters Friday. The remainder are set to be cleaned by Saturday [July 11].
    • “Officials sought to reassure those who live in or have visited the area in recent weeks, pointing out that they would have already been exposed to the bacteria and noting that most people don’t fall ill from it.
    • “It’s safe for folks to drink water, to bathe to shower to cook and to use their air conditioner,” NYC Health Commissioner Alister Martin said.”
  • Health Day tells us,
    • “U.S. Sen. Lindsey Graham, 71, died Saturday of an aortic dissection, a sudden tear in the body’s main artery
    • “The condition is often fatal; about half of patients reach the hospital, and roughly half of those survive
    • “High blood pressure is the leading risk factor, and sudden severe chest or back pain is the key warning sign.”
  • and
    • “Weight-loss meds are transforming obesity treatment.
    • “But when it comes to heart health, exercise may still be the game changer.
    • “The study shows that while medication supports weight maintenance, it is exercise — with or without medication — that improves vascular health,” said researcher Signe Torekov, a professor of biomedical sciences at the University of Copenhagen in Denmark.”
  • MedPage Today adds,
    • “A network meta-analysis backed weight-loss benefits with several GLP-1 receptor agonists, with less certainty for newer-generation agents.
    • “Two GLP-1 drugs were also associated with reduced heart failure risk, while subcutaneous semaglutide stood alone in being tied to a reduced risk of all-cause mortality and myocardial infarction.
    • “The evidence was less certain for a reduction in kidney failure or an improvement in quality of life beyond a subjective threshold.”
  • STAT News informs us,
    • “Health secretary Robert F. Kennedy Jr. is pressing forward with his effort to help Americans stop taking psychiatric drugs, a medical practice known as deprescribing.
    • “Earlier this month, dozens of mental health professionals met with federal health officials to map out forthcoming clinical guidance they hope will help providers instruct patients on how to come off of antidepressant medications. While the Department of Health and Human Services has discussed plans to hold such a meeting, the outlines of the discussion haven’t been reported.
    • “During those talks, they reviewed guidance from European nations and worked on recommendations for nonmedication-based options for patients to address their mental health, such as therapy. A senior HHS official said they discussed gaps in the research around deprescribing SSRIs, including the side effects a person may experience, which vary depending on the drug and how long the person was on it, and how to recognize the difference between those side effects and a return of a patient’s depressive symptoms.”
  • MedPage adds,
    • “Modifiable dementia risk factors varied widely from country to country and a one-size-fits-all approach to dementia prevention will not work everywhere, data from 14 countries and regions showed.
    • “Both differences and similarities emerged in a global analysis of risks for 214,000 older adults, reported Emma Nichols, PhD, of the University of Southern California in Los Angeles, at the Alzheimer’s Association International Conference.
    • “Low education was a prevalent dementia risk factor for 85.6% of people in China compared with 12.0% of Americans, Nichols said. Obesity was a risk factor for 44.9% of older adults in the U.S., but only 13.3% of people in India.
    • “Despite differences in prevalence, similar factors — like cardiovascular risks (high cholesterol, hypertension, and diabetes) or risky behaviors (smoking and drinking) — tended to cluster together. Poor hearing, poor vision, and low education also co-occurred frequently.
    • “Risk factors often overlapped, with more than 50% of individuals having at least two risk factors, Nichols pointed out. In 11 countries and regions, the prevalence of at least four risk factors exceeded 20%.
    • “The findings were published in Lancet Healthy Longevity.
  • The CDC posted updated Core Elements of Outpatient Antibiotic Stewardship.
    • “Outpatient antibiotic stewardship programs promote appropriate antibiotic use to improve patient care and help combat antimicrobial resistance.
    • “The Core Elements of Outpatient Antibiotic Stewardship Programs provides a framework to improve antibiotic use and guide stewardship efforts for health systems, outpatient facilities, and prescribing clinicians.
    • “The guidance includes an assessment tool for evaluating stewardship efforts, a resource for measuring antibiotic use, and fact sheets that tailor stewardship strategies to specific outpatient settings.”
  • Per Health Day,
    • “Half as many young adults are misusing Adderall, Ritalin and other ADHD medications these days to help them remain alert at study or work, a new evidence review says.
    • “Misuse of ADHD stimulant meds among adults under 30 fell from 7.5% in 2016 to 3.7% in 2023, researchers report in the Journal of Clinical Psychopharmacology.
    • “We found a rapid drop in misuse of these medications, largely driven by a decline in Adderall misuse among young adults,” lead researcher Margaret Maglione said in a news release. She’s a project leader with the Southern California Evidence Review Center at the Keck School of Medicine of USC.”
  • Per MedTech Dive,
    • “Freenome said its updated blood-based colorectal cancer screening test met its primary and secondary endpoints in a pivotal validation study. Called SimpleScreen CRC, the new test showed improvement over an earlier version, particularly in detecting precancerous lesions. 
    • “Abbott, which inked a collaboration agreement with Freenome last August to bring SimpleScreen CRC to market, will commercialize the test when it gains Food and Drug Administration approval, Freenome said Thursday.
    • “The latest study results set up Abbott to be the dominant player in colorectal cancer screening, Evercore ISI analysts said in a note to clients.”

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

  • Healthcare Dive reports,
    • “Hospital dealmaking remained hot during the second quarter of 2026, extending a merger and acquisition rebound that has lately seen more mid-to-large independent systems in pursuit of financial security and growth, according to a new report. 
    • “Healthcare advisory firm Kaufman Hall, in its latest quarterly M&A report, tallied 18 new hospital transaction announcements from April through June. That’s well ahead of the eight logged during the same window last year, and comfortably above the average posted by the sector across the 2020s. 
    • “Total transacted revenue was $7.7 billion for the most recent quarter, which the firm noted was a major rebound from the $1.4 billion a year prior but falls well short of most prior years.” * * *
    • “Joining the M&A report was new hospital operating data from May suggesting a slight downturn in margins both month-to-month and compared to last year.
    • “Among the 1,300 hospitals Kaufman Hall taps for its monthly sector benchmarks, the firm reported a calendar year-to-date operating margin index of 2.9%, and a single-month operating margin index of 2.7% (both including health system allocations for the cost of shared services).
    • “The former of those reflects a 6% pullback from April’s data, and a 4% dip from May a year prior. The latter, year-to-date margin is a 5% decline from the preceding year as of the same point.” 
  • The American Hospital Association relates,
    • AHA Chair Marc Boom, M.D., presented three AHA awards during the 2026 Leadership Summit, recognizing hospitals and health systems for innovation, advancing health and excellence. See the news releases for more details on the winners and honorees.  
      • The 2026 Foster G. McGaw Prize for Excellence in Community Service, recognizing healthcare organizations for commitment to community service through programs that make communities healthier and more vital, was presented to Sky Lakes Medical Center in Klamath Falls, Ore.  
      • The 2026 Quest for Quality Prize, honoring hospitals and health systems that exemplify excellence in delivering high-quality, safe and patient-centered care, was presented to the Ralph H. Johnson VA Health System in Charlotte, N.C. 
      • The 2026 Circle of Life Award, recognizing outstanding programs in palliative and end-of-life care, was presented to Erie County Medical Center of Buffalo, N.Y., and the Geriatrics and Extended Care Hospice and Palliative Medicine Team of Orlando VA Health Care System in Orlando, Fla. 
  • Beckers Payer Issues tells us,
    • “Rejections of initial brand-name prescription attempts increased from 24.3% in 2018 to 40.7% in 2024, according to a July 9 JAMA study.
    • “Researchers from Baltimore-based Johns Hopkins Bloomberg School of Public Health and the American Enterprise Institute led the study. Looking across various types of coverage, they reviewed 1.17 million people’s pharmacy claims data for more than 2 million prescription attempts for brand-name drugs that lack generic alternatives. 
    • Here are six other things to know from the study:
      • 1. Overall, between 2018 and 2024, 32% of initial fill attempts were rejected.
      • 2. Of that share, the rejected molecule was ultimately filled within 90 days in 38.6% of cases, and a different drug in the same therapeutic class was filled for 13%. However, 48.4% had no medication filled in the same therapeutic class within that window.
      • 3. For those who ultimately received the same molecule or a therapeutic substitute, treatment was delayed an average of 12.2 days after that initial rejection.
      • 4. While 68% of the requests were paid after the initial fill attempt, 14.8% were rejected due to a formulary exclusion and 17.2% due to required prior authorization or step therapy.
      • 5. Rejections were steepest among exchange and Medicaid managed care plans, at 48.7% and 49.8%, respectively.
      • 6. Rejection rates were lower among Medicare plans.
  • Beckers Health IT informs us
    • “Technology services company UST is integrating Anthropic’s Claude into CarePath, a platform providers and payers use to run claims processing, care management and member services.
    • “Claude connects CarePath directly to underlying claims and care systems, turning fragmented health data into recommended next steps for care teams, per a July 9 Anthropic news release. Every action Claude recommends routes to a person for approval before it reaches a member, and the integration operates within the data controls healthcare requires.” * * *
    • “The company [UST] is betting that pairing Claude’s reasoning capabilities with human-approval workflows can move AI-led decisions out of pilot programs and into the production systems regulated industries depend on.”
  • Fierce Healthcare points out,
    • “Venture capital funding for digital health startups is on an upswing, fueled by an AI-powered rebound following a post-pandemic reset in 2023.
    • “Digital health companies raised $7.4 billion in the first half of 2026, up $1 billion compared to the first half of 2026 ($6.4 billion raised), according to Rock Health’s analysis of digital health deals in the first half of 2026. There were 244 deals in H1 2026. Investors poured $3.2 billion into the sector in Q2, just shy of Q1’s $4.2 billion.
    • “Building on trends from last year and into Q1 this year, capital is concentrating among a small number of megadeals as venture capital investors place their bets on innovative digital health companies, Rock Health researchers Ashwini Nagappan, Jason Lei and Maddie Knowles wrote.”

Friday report

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

Simplicity is a virtue.

From Washington, DC

  • Federal News Network reports
    • “Federal retirement processing times are slowing down. During June, it took the Office of Personnel Management an average of 108 days to process a retirement claim, according to the agency’s latest data release. Processing times for digital-only applications averaged 96 days. That’s a full 30 days longer than the previous month’s average. But at the same time, OPM’s retirement claim inventory in June was the lowest it’s been all year, coming in at just under 34,000 pending applications. OPM received close to 9,000 new claims last month and processed nearly 13,000.(June 2026 retirement processing statistics – Office of Personnel Management)
  • FEHBlog observation: It’s hardly surprising that a slow down occurred during last month’s big processing system change.
  • Federal News Network adds
    • “There’s room for improvement in the Office of Personnel Management’s efforts to prevent improper retirement payments. OPM’s use of manual processes and delays in payment suspensions are hampering the ability to mitigate improper retirement payments. A recent report from OPM’s inspector general office recommends that the agency tighten its timeline and transition to digital tools to help identify and prevent overpayments or underpayments to federal retirees. Officials in OPM’s retirement services division say discussions are ongoing to automate various surveys and projects associated with improper payment prevention.(Evaluation of OPM Retirement Services’ efforts to identify and prevent improper payments – OPM Office of Inspector General)”
  • The American Hospital Asssociation News relates,
    • “The Health Resources and Services Administration has announced new funding available to healthcare providers in rural areas through the Small Health Care Provider Quality Improvement Program. Up to 20 grantees may be awarded up to $250,000 each to providers, such as critical access hospitals, rural health clinics or networks of small rural providers, to build programs that collect and use clinical data and evidence-based approaches to improve healthcare quality, particularly focused on improving chronic disease outcomes. The grant also is intended to be used to strengthen the skills and collaboration of the billing and coding staff in coordination with the front-line clinical staff. Applications must be submitted by Aug. 6, 2026.”
  • Fierce Healthcare informs us,
    • “Participants in the ACO REACH program generated nearly $1 billion in savings in 2024, according to new performance data from the Trump administration.
    • “The Centers for Medicare & Medicaid Services released its latest look at program performance on Thursday, which found $988.3 million in net savings for the federal government from the accountable care program. Gross savings, before accounting for benchmark discounts and shared savings arrangements, were $2.5 billion, according to the report.
    • “Net shared savings payments to the ACOs totaled $1.5 billion, for a shared savings rate of 4.2%.
    • Most of the 115 ACOs participating in REACH for 2024 earned shared savings, according to the report. Just 19 ACOs, or 17%, posted a net loss, while 96 organizations, or 83%, earned savings.
    • The participating ACOs also generally maintained high performance on quality, CMS said, with 49 organizations qualifying for the high performance pool that allows them to earn additional financial benefits. This pool was first offered for the 2023 program year, CMS said.
    • The ACO REACH model is set to conclude at the end of 2026, and the Center for Medicare and Medicaid Innovation will transition to a new model called Long-Term Enhanced ACO Design (LEAD) beginning on Jan. 1.

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration July 10 released a proposed rule that would modernize drug establishment registration requirements, with implications for pharmaceutical manufacturers and health systems that depend on a stable medication supply chain. The proposal would create a streamlined registration process for distributed manufacturing operations that use a “hub-and-spoke” model, allowing qualifying networks to register as a single establishment rather than registering each manufacturing unit separately.
    • “The rule would also clarify registration and drug listing requirements for certain foreign manufacturers, including facilities that produce active pharmaceutical ingredients destined for the U.S. market through intermediary facilities. FDA officials said the change would improve visibility into upstream supply chains and strengthen the agency’s ability to identify and respond to potential safety and quality concerns.”
  • Fierce Pharma informs us,
    • “The increasingly more popular combination of Padcev and Keytruda has expanded its bladder cancer territory once again.
    • “Thanks to an FDA nod on July 10, Padcev and Keytruda have become the first muscle-invasive bladder cancer (MIBC) treatment that does not require considerations over the patient’s eligibility for cisplatin-based chemotherapy. 
    • “The latest go-ahead allows the combo as neoadjuvant treatment before surgery, followed as adjuvant treatment after surgical removal of the bladder in MIBC, building on a previous perioperative indication that was limited to cisplatin-ineligible patients. 
    • “The inclusive MIBC label adds to the Padcev-Keytruda combo’s well-established profile in metastatic bladder cancer. It arrives more than a month earlier than the FDA’s target decision date of Aug. 17 under an already accelerated priority review timeline. “
  • and
    • “The third time is not the charm for Hengrui Pharma and Elevar Therapeutics’ star-crossed combination of camrelizumab and rivoceranib at the FDA.
    • “U.S. regulators have declined to approve the anti-PD-1/VEGFR combo for a third time as a first-line treatment for liver cancer, Hengrui and Elevar’s parent company, HLB Group, said in separate announcements Friday.
    • “The problem, again, is manufacturing. Only this time, the complete response letter (CRL) stemmed from deficiencies the FDA had identified in April at the plant producing rivoceranib, also known as apatinib, unlike the previous two rejections, which centered on Hengrui’s camrelizumab facility, according to the Chinese pharma. The rivoceranib manufacturer had passed an inspection by EU authorities in 2025, it noted.
    • “Still, three CRLs do not necessarily mean three strikes and you’re out for Hengrui and Elevar.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of July 10, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is very low in most areas of the country. Emergency department visits and hospitalizations for RSV are low but remain highest among infants and children younger than 4 years old.
    • “COVID-19 activity is low and stable nationally but is beginning to increase from low in a few areas of the country.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV), a respiratory virus that can cause illnesses such as croup, is elevated nationally. Rhinovirus/enterovirus (RV/EV), which often cause cold-like respiratory illness, are also elevated nationally but is going down. Whooping cough (pertussis) is still circulating.”
  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) confirmed 61 new US measles cases today and 2,231 for the year, as Virginia has become the country’s latest hot spot.
    • “Last year the CDC recorded 2,289 infections for the entire year, so the nation is just 58 cases short of that as we pass the midpoint of the year. The 2025 total was the most since 1991, and the United States is now on track to lose its measles elimination status that it gained in 2000.
    • “All but 13 of this year’s cases were locally acquired, with the rest related to travel outside the country. Of the total, 20% of infections are in children age 5 and under, and 70% involve kids and young adults to age 19. Six percent of patients have been hospitalized, compared with 11% in 2025. Among all measles patients, 93% are unvaccinated or have unknown vaccine status. 
    • “No measles deaths have been reported this year, compared with three in 2025.”
  • The American Hospital Association News relates,
    • “The Centers for Disease Control and Prevention has reported 843 cases of cyclosporiasis across 31 states, with 86 people hospitalized. State health departments are reporting higher case numbers than the CDC, which works to confirm the cases reported to it. Michigan has announced that it is investigating 1,562 cases, with 44 people hospitalized. No deaths have been reported, and investigators haven’t identified a source.”
  • The New York Times adds,
    • “How to Stay Safe From the Severe Stomach Bug That’s Going Around
      • “Cyclospora, a parasite that causes intestinal illness, is sickening many people across the United States. Health experts have tips for avoiding infection.”
      • “Past cyclospora outbreaks in the United States have mainly been linked to fresh produce, including raspberries, basil, cilantro, fruit mixes, snow peas, snap peas, lettuce and salad mixes. They have been caused by both imported and domestic fruits and vegetables and those prepared at home and in restaurants, said Donald Schaffner, chair of the food science department at Rutgers University.
      • “Because the cause of the recent infections is unknown, the best way to prevent illness is to follow standard hygiene and food safety practices, said Dr. Adam Ressler, an infectious disease physician with Michigan Medicine.
      • Always wash your hands with soap and water after using the bathroom and before preparing food, Dr. Moore said. Alcohol-based hand sanitizers do not kill cyclospora, he said, but soap and water does.
      • “Rinsing fruits and vegetables with water is always a good practice, Dr. Moore said. Some cyclospora may still cling to contaminated produce after rinsing, but it will reduce their numbers and in turn can reduce your risk of getting sick or make the illness less severe, he said.
      • “Cleaning produce with vinegar or other solutions is generally no more effective than doing so with running water, Dr. Schaffner said.”
  • Cardiovascular Business tells us,
    • “Data on the potential relationship between cannabis use and cardiovascular disease (CVD) remain mixed. Some studies have linked cannabis to an increased risk of heart attack and ischemic stroke, for example, but the current evidence is far from consistent. 
    • “With cannabis legalization skyrocketing in the United States, the team behind a new analysis in Trends in Cardiovascular Medicine hoped to explore the latest evidence and provide a fresh look at this important topic.[1]
    • “Compared with respiratory or psychiatric outcomes, the cardiovascular consequences of cannabis remain poorly established,” wrote first author Ahmed K. Mahmoud, MD, a cardiovascular health researcher with Mayo Clinic, and colleagues. “This highlights the urgent need for prospective studies and clinical trials to more clearly define cardiovascular risk.”
  • The University of Minnesota’s CIDRAP informs us,
    • “A new study finds that the antiviral drug Paxlovid can safely be used by children aged 6 and older.
    • “The study, published recently in Pediatrics, found Paxlovid, which combines the drugs nirmatrelvir and ritonavir, is safe for children who weigh at least 44 pounds who have mild to moderate COVID-19 but are at risk of developing severe disease.
    • “Paxlovid is approved by the US Food and Drug Administration in children at least 12 years old who weigh at least 88 pounds.
    • “The study included 75 children 6 to 17 years old who received at least one dose of Paxlovid. One group received a lower dose and the other a higher dose. 
    • “Researchers found that both doses were safe and well-tolerated, with no serious adverse events. In 90% of participants in both groups, blood concentrations of the drug reached levels that have been shown to have antiviral effects in adults.”
  • BioPharma Dive points out,
    • “An experimental drug GSK licensed from Hansoh Pharma has succeeded in a late-stage study in China, boosting the outlook for a therapy the British pharmaceutical company has already advanced into a series of large global trials. 
    • “GSK said Friday that the antibody-drug conjugate risvutatug rezetecan, or ris-rez, improved survival in people with advanced or relapsed small cell lung cancer when compared to standard treatment, meeting the trial’s main objective. The company didn’t provide specifics, but said that the drug was associated with “statistically significant and clinically meaningful improvements” in survival compared to that typical treatment, the chemotherapy topotecan. Riz-rez also produced “consistent benefits” across secondary study measures, including delaying tumor progression, according to GSK.” 

From the U.S. / worldwide healthcare business front,

  • The Wall Street Journal reports,
    • “Asset-management firm Apollo Global Management APO  agreed to buy a minority stake in Bayer’s BAYN  long-acting reversible contraceptives business for €3 billion, or $3.43 billion, the companies said.
    • “German pharmaceutical company Bayer said it secured €3 billion in equity capital, as part of an agreement with Apollo for its managed funds and affiliates to obtain a minority stake in a new entity. The newly established entity will hold Bayer’s long-acting reversible contraceptives business.
    • “Bayer will retain a majority stake in and full operational control over the business, it said.
    • “The long-acting contraceptives business focuses on methods that prevent pregnancy for a long period of time, such as the intrauterine device, according to Bayer’s website.”
  • Modern Healthcare relates,
    • “Health systems and insurers are trying to minimize poorly executed handoffs between post-acute facilities and home care providers that are costing them millions of dollars in hospital readmissions.
    • “CenterWell, Optum and Banner Health are using a combination of technology, staffing and their own post-acute operations to ensure patients receive timely and consistent care as they transition from skilled nursing facilities to home following a hospital stay.” 
  • Fierce Pharma tells us,
    • “The launch of Eli Lilly’s Foundayo remains “muted,” with weekly prescriptions flat over the last five weeks, analysts from Jefferies said in a July 10 note. The analysis is based on data collected by IQVIA.
    • “In the 13th week of Foundayo’s launch, IQVIA reported 19,550 prescriptions, down for the third straight week after peaking at Week 10 with 21,648 prescriptions. The figure also comes in significantly shy of the Week 13 launch of Novo’s Wegovy pill (more than 105K scripts) and Lilly’s injected obesity treatment Zepbound (59K), but ahead of Novo’s injected Wegovy (13K).
    • “Meanwhile, weekly scripts for Wegovy pill ticked slightly upward sequentially to about 153K, although they still lag behind the drug’s peak of more than 161K.
    • “Jefferies points out that CVS was the last of the big three PBMs to provide coverage of Foundayo, starting on June 1. By contrast, Wegovy had full coverage at the first week of its launch.
    • “While Jefferies’ $71 million quarterly sales projection for Foundayo sits significantly below Wall Street consensus of $130 million, the team still believes that the Lilly med can reach the consensus revenue estimate of $1.2 billion for 2026.”
  • Kaufmann Hall informs us,
    • “Most U.S. adults who use social media engage with health-related content, including sharing health information, according to a study published last month in JAMA. This includes joining online health communities and sharing personal or general health information, with more than one in five adults making health decisions based on what they see online. However, many adults also doubt the accuracy of health information on social platforms. This suggests a public health problem: social media has become a major health information channel, but one built for engagement rather than reliability. This comes as healthcare organizations explore “influencer engagement” as a way to introduce credible information into spaces where patients already are, and where trust is being shaped.”

Notable Death

  • The Wall Street Journal reports,
    • “For decades, oncologists blamed cancers of the mouth and throat on excessive use of tobacco or alcohol. It was typically an old man’s disease.
    • “Starting in the 1980s, they were shocked to see more of these so-called oropharyngeal cancers in people—often young or middle-aged men—who had little or no history of drinking or smoking. A few oncologists suggested those might be caused by the human papillomavirus, or HPV, just as cervical and some other cancers are. But most scoffed at that idea.
    • “In the late 1990s, Maura Gillison, a doctoral student at Johns Hopkins University who was then in her early 30s and little known in the field, sought to resolve the debate. She competed with other researchers for access to scarce tissue samples from human tumors and led a team analyzing them for clues. That work led to a 2000 article in the Journal of the National Cancer Institute demonstrating that HPV-related cases were very different from those related to tobacco or alcohol—and less deadly.”
    • “Gillison, who died June 21 at the age of 61, built on that work with more studies, describing how HPV-related cancers required different treatment—typically less aggressive than the intensive chemotherapy and radiation applied to many non-HPV cancers. These findings saved lives and spared patients from needless treatments and side effects, cancer specialists say.”
  • RIP

Thursday report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Federal employment benefits, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • STAT News reports,
    • ‘ARPA-H, the U.S.’ “moonshot” agency for health research, announced Thursday that it will spend up to $160 million to push forward custom gene editing treatments for a spate of rare diseases. 
    • ‘The program, called THRIVE, will back seven different teams pursuing various groups of conditions affecting different organ systems. 
    • “Each team has a deadline of starting clinical trials by year three of the program, although some may start much sooner.” * * *
    • “Each of the groups will work with a partner, such as a biotech company or contract manufacturer, or multiple partners to assure they can manufacture the program to Food and Drug Administration standards.”
  • Beckers Hospital Review relates,
    • “Peptides have become one of the most closely watched regulatory questions in healthcare this summer, with a federal advisory committee vote set for July 23-24 that could reshape what’s legally available to prescribers, wellness clinics and patients nationwide.
    • “What are peptides?
      • Peptides are short chains of amino acids that often serve as signaling molecules for physiological functions in the body, including tissue repair, metabolism and inflammation. Some peptides, like insulin and semaglutide, the active ingredient in Ozempic and Wegovy, are FDA-approved drugs. Others — including BPC-157, TB-500 and a handful of others marketed for injury recovery, weight loss, sleep and anti-aging — have circulated for years through wellness clinics, medical spas and online retailers without ever being FDA-approved or added to the list of substances legally allowed in pharmacy compounding. 
      • “That distinction matters because of how compounding law works. Under Section 503A of the Food, Drug and Cosmetic Act, a licensed pharmacy can only compound a drug for an individual patient using a bulk substance if it’s FDA-approved, has a recognized USP monograph, or appears on the FDA’s 503A Bulks List. If a peptide isn’t on that list, pharmacies generally can’t legally compound it — which is exactly the question now in front of regulators. 
    • “The upcoming vote 
      • “The FDA’s Pharmacy Compounding Advisory Committee meets July 23-24 to decide whether seven peptides should be added to the 503A bulks list: BPC-157, KPV, TB-500 and MOTs-C, Emideltide (also called DSIP), Semax and Epitalon. The committee’s recommendation is non-binding, but the FDA has historically followed it.”
  • Tammy Flanagan, writing in Govexec, explains OPM’s new all-digital federal retirement benefit application process.
  • Per an HHS news release,
    • “President Donald J. Trump signed an Emergency Declaration for the Northern Mariana Islands and the Territory of Guam, and Secretary Robert F. Kennedy, Jr. has declared a public health emergency to address the consequences of Typhoon Bavi. Under these circumstances, the Secretary has also exercised the authority to waive sanctions and penalties against a covered hospital that does not comply with the following provisions of the HIPAA Privacy Rule:
      • the requirements to obtain a patient’s agreement to speak with family members or friends involved in the patient’s care. See 45 CFR 164.510(b).
      • the requirement to honor a request to opt out of the facility directory. See 45 CFR 164.510(a).
      • the requirement to distribute a notice of privacy practices. See 45 CFR 164.520.
      • the patient’s right to request privacy restrictions. See 45 CFR 164.522(a).
      • the patient’s right to request confidential communications. See 45 CFR 164.522(b).
    • “When the Secretary issues such a waiver, it only applies: (1) in the emergency area and for the emergency period identified in the public health emergency declaration; (2) to hospitals that have instituted a disaster protocol; and (3) for up to 72 hours from the time the hospital implements its disaster protocol. When the Presidential or Secretarial declaration terminates, a hospital must then comply with all the requirements of the Privacy Rule for any patient still under its care, even if 72 hours has not elapsed since implementation of its disaster protocol.”

From the Food and Drug Administration front,

  • USA Today reports,
    • “If headlines about heavy metals in tampons raised concerns, the Food and Drug Administration says there’s some reassuring news.
    • “A new agency study found trace amounts of metals including arsenic, cadmium and lead in tampons sold in the U.S., but concluded the levels released during use are too low to pose a health risk.
    • “The findings are the FDA’s latest response to a widely publicized 2024 study that detected metals in popular tampon brands and sparked questions about possible health effects. After analyzing 11 tampon products from six brands, FDA researchers found that while metals can be detected in the products, exposure during normal use remains far below levels considered harmful.”
  • MedTech Dive informs us,
    • “Johnson & Johnson has won Food and Drug Administration approval for a catheter that delivers radiofrequency and pulsed field energy to treat atrial fibrillation.
    • “The approval, which J&J disclosed Wednesday, covers the Dual Energy Thermocool Smarttouch SF Platform. J&J already had approval for a single, radiofrequency energy version of the device.
    • “Integrated into the company’s Carto mapping system, the dual-energy catheter is part of J&J’s push to leverage its electrophysiology strength to reverse market share losses triggered by PFA.”
  • The American Hospital Association News relates,
    • “The Food and Drug Administration has issued an early alert for specific lots of BD ChloraPrep Applicators by Medline because of a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. Medline has instructed impacted customers to remove the recalled convenience kits from where they are used or sold. The company said that other components within the convenience kits may still be used.” 
  • BioPharma Dive cautions,
    • “The regulatory gears in the U.S. are increasingly creaking under the weight of new, complex drug technologies and intensifying overseas clinical trials competition from countries like China and Australia.
    • “Now, the Department of Health and Human Services is making moves to speed early drug research under a new plan dubbed Operation Trialblazer. The blueprint, which involves initiatives at multiple federal agencies, including the Food and Drug Administration and the National Institutes of Health, focuses on modernizing regulations and processes, improving patient access and participation, and enhancing the use of data and technology to streamline the regulatory process.
    • “It’s the latest in a series of actions aimed at supporting drug research. But whether the new reforms will make a meaningful impact is an open question.” 

From the judicial front,

  • Fierce Healthcare reports,
    • “CVS Health and its embattled Omnicare unit have agreed to pay $440 million to the Department of Justice to satisfy a nearly $950 million judgment against the company as part of an ongoing fraud case.
    • “In April 2025, a federal jury ruled that Omnicare submitted more than 3.3 million fraudulent prescription claims between 2010 and 2018, earning $135.6 million in overpayments as a result. Then, in July 2025, a judge ordered Omnicare to pay $948.8 million in fees and damages as part of the case.
    • “In the new court docs, CVS said that it has agreed to make an initial $130 million payment within 14 days of the agreement’s effective date. The remaining $310 million must be paid out by March 15, 2028.
    • “The agreement with DOJ is contingent on the closure of Omnicare’s sale to GenieRx Holdings, according to the filing. As it navigated the legal fallout of the False Claims Act case, Omnicare filed for bankruptcy in September 2025, and CVS announced plans to sell to GenieRx in May of this year.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Annual cancer cases are projected to rise considerably worldwide by 2050, according to a World Health Organization report on cancer published Wednesday. With its assessment, the United Nations body tempered optimism about improvements in cancer surveillance and treatment and warned that global health care inequities are driving further cases and deaths. 
    • “Around 20.6 million people were diagnosed with cancer in 2024, according to the findings. That number could reach 35 million a year by 2050.
    • “The new cases will disproportionately appear in lower-income countries with poorer access to cancer surveillance and treatment, according to the report.” * * *
    • “In the United States, the rate of new cases has generally been stable in recent years, according to the National Institutes of Health. The WHO report predicts that cancer rates will increase in all regions across the world, though the biggest increases are projected in Africa and the Eastern Mediterranean region.”
  • Health Day adds,
    • “More men die from cancer than women, and a new study suggests one potential reason why.
    • “Men are more likely than women to be diagnosed with advanced cancer that has spread to other parts of the body, researchers report in the July issue of the journal Cancer Epidemiology, Biomarkers & Prevention.
    • “That means their cancer is being detected too late, when it’s tougher to treat and more likely to be fatal, researchers said.
    • “We know that, overall, males are more likely than females to die from many types of cancer. We also know that cancer stage at diagnosis is a key predictor of cancer survival,” lead researcher Beth Maclin, a postdoctoral fellow at the National Cancer Institute in Bethesda, Maryland, said in a news release.” * * *
    • “My overall message is that everyone should go to the doctor regularly,” Maclin said. “Don’t delay seeing a doctor if you notice something has changed in your body.”
  • The AP relates,
    • “Nearly 1,000 people in Michigan have been diagnosed with a parasitic infection that can cause weeks of watery diarrhea, making it the largest such outbreak in state history and one of the nation’s largest in years.
    • “No deaths have been reported and the source of the cyclospora infections hasn’t been identified. Meanwhile, investigations into similar illnesses have been going on in 28 other states, including in Ohio, where people just across the Michigan border are also becoming sick.
    • “Michigan officials first announced the outbreak last week, when they were aware of more than 170 cases — all in the southeastern corner of the state — since June 22. Michigan usually identifies only about 50 cases each year.
    • “On Wednesday, the state reported the number had grown to 992, including about 40 hospitalizations. Just across the state line, Lucas County, Ohio, reported 306 cases as of Wednesday. Northwest Ohio has seen more than 500 cases.
    • “Cyclospora surges can be tricky to investigate, and food poisoning sources can be hard to establish. But “there is clearly a linked outbreak happening right now,” Dr. Natasha Bagdasarian, Michigan’s chief medical executive, told The Associated Press on Wednesday.”
  • MedPage Today tells us,
    • “Chronic kidney disease prevalence held steady at around 14.8% over the last decade, despite treatment advances.
    • “This translated to an estimated 36 million affected U.S. adults, based on national health survey data.
    • “The prevalence of diabetes-related chronic kidney disease increased during the period spanning 2013-2014 to 2021-2023.” * * *
    • “This means single-organ care is no longer enough, said [Sophie] Claudel [, MD]. Based on the data, a growing proportion of the population may be at risk for progressive cardiovascular-kidney-metabolic (CKM) syndrome.
  • Healio informs us,
    • “GLP-1s may prevent adverse outcomes in patients with peripheral artery disease and diabetes, according to data published in the Journal of the American Heart Association. 
    • “Researchers reported that GLP-1 receptor agonist use among patients with PAD and diabetes was associated with lower risk for mortality, hospitalization, revascularization and amputation compared with those prescribed metformin.
    • “Obesity and PAD, including chronic limb-threatening ischemia, are linked to increased inflammation, poor blood vessel function, insulin resistance, oxidative stress and faster hardening of the arteries,” Akiva Rosenzveig, MD, cardiology fellow at Cleveland Clinic, said in a press release. “These results indicate GLP-1 [receptor agonists] can help reduce inflammation, improve blood vessel function and manage blood sugar levels.”
  • Medscape adds,
    • “The FDA approved Zepbound (tirzepatide) in December 2024 for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in patients with obesityafter research showed that the medication improved outcomes in these patients.
    • “Sleep apnea is among the most common sleep disorders. It occurs when the airways relax and block breathing during sleep. Patients may repeatedly stop breathing, leading to disrupted sleep, snoring, and excessive sleepiness during the day.
    • “Now new research has shown that certain patients seem to benefit more than others from the medication. Patients with the most severe sleep apnea along with those who are younger and have less severe obesity experienced nearly twice the reduction in symptoms compared to those who are older and have more severe obesity.”
  • Fierce Pharma points out,
    • “In a first for the neurotoxin market, Ipsen announced Thursday that its Dysport has hit the goals in two phase 3 trials for the prevention of both episodic and chronic migraines.
    • “While AbbVie’s market-leading Botox has been approved by the FDA to prevent headaches in patients with chronic migraine since 2010, Dysport is now the first botulinum toxin to also report positive phase 3 results in episodic migraine, according to Ipsen.
    • “The readouts come from studies in Ipsen’s Beond program, comprising 1,510 patients, split between C-Beond (chronic) and E-Beond (episodic). Both trials have met their primary endpoints, showing a statistically significant reduction in monthly migraine days versus placebo.
    • “Together, these findings position Dysport as a potential first-in-class treatment for a broad migraine population,” Ipsen’s global head of R&D, Christelle Huguet, Ph.D., said in a July 9 statement.
    • “Ipsen will review the full data and prepare for regulatory filings, including with the FDA, a company spokesperson told Fierce Pharma.” 
  • BioPharma Dive lets us know,
    • “A nucleic acid-based medicine from AstraZeneca and Ionis Pharmaceuticals missed its main objective in a big study of people with a deadly heart condition in a major setback with notable ramifications for multiple other drugmakers. 
    • “In a pair of statements, the companies said that when compared to a placebo in people with transthyretin-mediated amyloid cardiomyopathy, or ATTR-CM, their drug, eplontersen, didn’t significantly reduce the risk of death or recurrent cardiovascular events after 140 weeks. Eplontersen had no treatment effect among participants already receiving a commonly used “stabilizer” medication. A 29% risk reduction was observed in people who weren’t getting those drugs, AstraZeneca and Ionis said.
    • “The companies didn’t provide additional study details, only noting that the drug was “well tolerated” and showed positive signs on multiple other secondary study measures. Those specifics will be presented at a medical meeting in August. “
  • and
    • “Roche said Thursday it’s discontinuing two Ionis-partnered drugs for Huntington’s disease after clinical setbacks, with one missing its main trial goal and the other suspended because of a safety worry.
    • “A Phase 2 test of the antisense oligonucleotide tominersen “did not meet its efficacy objective” in spite of having a significant impact on biological disease signs, Roche said in a letter to patient groups. Meanwhile, enrollees in a Phase 1 trial of a drug codenamed RG6496 won’t receive a second dose because animal safety testing revealed that it “cannot be given chronically with repeated doses,” Roche said.
    • “The Swiss pharmaceutical giant had once before suspended a late-stage trial of tominersen because it didn’t appear to be helping patients. Roche forged ahead with a hypothesis that younger and less-advanced patients might benefit, but now that pathway has hit a dead end.”
  • Per Genetic Engineering and BioTechnology News,
    • “A landmark Phase I/II clinical study led by researchers at Skåne University Hospital and Lund University has shown that transplanting stem-cell-derived dopamine progenitor cells into the brain is feasible. Eight patients with Parkinson’s disease (PD) received transplants of STEM-PD, a cryopreserved, off-the-shelf dopaminergic progenitor product derived from human pluripotent stem cells. The three-year Phase I/II, open-label, multicenter, single-arm, dose-escalation study identified no serious side effects linked to the transplanted cells during the first year of follow‑up.
    • “The possibility of replacing dopamine neurons that are lost in Parkinson’s disease has been a long-standing goal in the field,” said Malin Parmar, professor of cellular neuroscience at Lund University, and lead of the STEM-PD program. “The findings represent an important milestone for regenerative medicine approaches in Parkinson’s disease and support continued clinical development of stem cell-based therapies.”
    • “Results from the study were reported by Parmar and colleagues in Nature Medicine. In their paper, titled “Human embryonic stem cell-derived dopaminergic cells for Parkinson’s disease: a Phase I/II open-label trial,” the team wrote, “In conclusion, particularly in the context of other recently published trials using human PS cell-derived dopaminergic cell therapies for PD, these findings further support the continued development of this therapeutic approach, including evaluation of the STEM-PD product in larger patient cohorts.”

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

  • Healthcare Dive reports,
    • “CVS’ insurance division Aetna has a finally gotten a handle on medical spending after a turbulent few years, according to the healthcare giant’s chief executive.
    • “We’ve got, I think, our arms around how to project and predict where healthcare costs are going, and making sure we’re pricing our products accordingly,” CVS CEO David Joyner said at an event hosted by the Economic Club in Washington, D.C., on Thursday.
    • “Joyner’s comments — which come about a month before CVS is scheduled to report second quarter results — are likely a welcome signal for investors that Aetna can continue recent progress on controlling spending.” * * *
    • “The biggest challenge for CVS isn’t managing members’ costs: It’s policy uncertainty out of Washington, Joyner said.
    • “I spend a lot of my time, both at the federal level and in the states, trying to help educate and also describe what are the real drivers of healthcare costs, and then making sure that we play an active role to help with members of Congress,” the CEO said.”
  • Fierce Healthcare relates,
    • “UnitedHealthcare is rolling out a new benefit option aimed at making it easier for employers to offer more personalized wellness programs.
    • “Called Lifestyle Spending Accounts (LSAs), the benefit allows employers to offer a stipend that members can put toward wellness solutions. The LSAs are integrated with UnitedHealth’s UHC Store, which is a digital storefront where members can purchase select health and wellness programs at a discount.
    • “The accounts exist alongside health savings accounts or flexible spending accounts, allowing individuals to purchase health and wellness generally not available under HSAs or FSAs, UnitedHealthcare said.”
  • Benefits Pro tells us,
    • “Both the levels and growth of health care spending from 2005 to 2023 were greatest among Americans with the highest incomes, according to a new report in Health Affairs.
    • “Among the lowest income quintile, spending grew more rapidly just after 2014 but declined from 2018 to 2023. By contrast, spending in the highest income quintile grew more rapidly in recent years. As a result, the difference in age and health status-adjusted spending between the highest and lowest income quintiles declined after implementation of the Affordable Care Act subsidies but increased more recently. The adjusted per capita spending difference in 2023 was more than $4,700.
    • “If spending continues its most recent trajectory, that difference will continue to grow,” the report said. “These spending patterns were driven largely by outpatient and prescription drug spending, which tend to be more discretionary than inpatient and emergency department spending. Prescription drug spending showed a particularly pronounced recent divergence for the top income quintile. Recent spending growth was most evident in the population younger than age 65, which has more variation in insurance coverage, affecting both service use and prices.”
  • Psychology Today lets us know,
    • “Mental health leave [under federal and state leave acts] has sharply increased in the U.S. since the pandemic.
    • “Women, especially caregivers, account for the majority of mental health leaves.
    • “Access to mental health leave highlights structural inequalities in the workplace.
    • “Early, ongoing treatment with an established provider can support the mental health leave process.”
  • Per Smart Brief,
    • “Healthcare AI’s next challenge isn’t adoption. It’s reliability
    • “Healthcare has reached a point where the challenge with AI is not adoption but ensuring it is accountable and dependable post-deployment, writes Sina Bari, vice president of healthcare and life sciences AI at iMerit.”
  • Per MedTech Dive,
    • “Stereotaxis said Thursday it finalized the acquisition of French surgical robotics company Robocath.
    • “Announced in April, the deal is valued at up to $45 million and brings together two robot developers focused on endovascular interventions, which are performed inside blood vessels.
    • “Combining the companies’ expertise will speed development of next-generation robotic technologies for electrophysiology, interventional cardiology and neurointerventions, the companies said.”
  • Per Fierce Pharma,
    • “Unexpectedly catapulted into global fame as a COVID-19 vaccine maker, BioNTech is on the verge of returning to its oncology roots with potentially its first commercial cancer drug. Yet, to Chief Commercial Officer Annemarie Hanekamp, the upcoming launch is less of a standalone milestone than a strategic springboard for a far more critical pipeline product. 
    • “Backed by positive phase 2 data and an ongoing confirmatory phase 3 trial, BioNTech is readying its Duality Biologics-partnered antibody-drug conjugate (ADC) trastuzumab pamirtecan (T-Pam) for submission with the FDA for previously treated HER2-expressing endometrial cancer. 
    • “If approved, the drug will compete with AstraZeneca and Daiichi Sankyo’s blockbuster HER2 ADC, Enhertu, which boasts a pan-tumor indication. Challenging the market leader, however, is not BioNTech’s end goal for T-Pam.
    • “This is not about competing head to head with Enhertu and overtaking them,” Hanekamp said in a recent interview with Fierce Pharma. “We’re very realistic, and we know in the oncology space, first-mover advantage matters. They’ve been in the market for a while, it’s an amazing drug, and we don’t claim to be all that differentiated versus Enhertu.”
    • “Instead, Hanekamp views T-Pam as a “strategic launch,” an exercise to “run water through the pipes” and test BioNTech’s commercial infrastructure in oncology.”

Tuesday report

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

Simplicity is a virtue

From Washington, DC,

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

From the Food and Drug Administration front

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Pre-holiday weekend report

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

Simplicity is a virtue

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

From Washington, DC,

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

No Surprises Act news

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Thursday Report

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

Simplicity is a virtue.

From Washington, DC,

  • STAT News reports,
    • “The chair of the Senate health committee introduced a bill to restrict a federal drug discount program known as 340B that has been lucrative for nonprofit hospitals.
    • “The bill by Sen. Bill Cassidy (R-La.) comes as hospitals face attacks on their bottom lines, especially in Medicaid. The tax bill that Republicans passed last summer significantly decreased the federal government’s share of Medicaid costs and is expected to reduce the number of people on Medicaid. Hospitals also face the prospect of legislation that would lower hospital payments to levels charged by doctor offices, an idea known as site-neutral payments.” * * *
    • “Cassidy’s bill would implement many pharmaceutical-industry backed restrictions on the program. It would allow drugmakers to give hospitals retroactive rebates, instead of the upfront discounts that hospitals prefer. Hospitals could insist on receiving upfront discounts, but only if they pass them on to patients. They’d also need to establish a sliding-fee scale for prescription drugs, effectively sharing some of the discounts with low-income and uninsured patients.” * * *
    • “Similarly, the bill would place restrictions on the contract pharmacies that hospitals use to administer the discounts. Hospitals would be limited to five contract pharmacies, which would be required to be located in a 340B entity’s service area. The bill also would define conditions for contract pharmacies to participate in the 340B program.” * * *
    • “There are also transparency measures in the bill. Hospitals would have to annually report profits from the drug discount program, the number and types of patients who received 340B drugs, and details of charity care they offer.”
  • The Whistleblower Network News relates,
    • “Sen. Chuck Grassley (R-Iowa) is calling on the Office of Personnel Management (OPM) to revise a proposed government-wide nondisclosure agreement, warning that the draft form could discourage federal employees from reporting waste, fraud, and abuse.
    • “On May 27, OPM, the federal government’s chief human resources agency and personnel policy manager, published a notice seeking public comment on a proposed nondisclosure agreement for use by federal agencies with new and existing employees. According to OPM, the proposed form is intended to standardize confidentiality obligations across the federal government and protect non-public, confidential and proprietary information obtained through official duties.
    • “Grassley, who chairs the Senate Judiciary Committee and co-founded the Senate Whistleblower Protection Caucus, warned that the draft does not go far enough to ensure federal employees understand that the agreement cannot override their whistleblower rights. In a letter to OPM Director Scott Kupor, Grassley urged the agency to update the draft NDA to include the full anti-gag provision required by federal law. Grassley also framed the issue as one implicating federal employees’ constitutional rights.”
  • The Wall Street Journal tells us “What to Know About the Government’s $6.5 Billion Healthcare Fraud Crackdown.”
    • “An $865,000 Bulgari necklace, $600,000 spent on vehicles and more are detailed in documents.”
  • The American Hospital Association News tells us,
    • “The House Energy and Commerce Subcommittee on Health June 25 held a markup session on bills regarding healthcare price transparency, illicit drugs and prior authorization. Bills considered by the subcommittee included the Lower Costs, More Transparency Act (H.R. 9393), legislation that would codify existing price transparency regulations for hospitals and health plans; the Prices on the Wall Act (H.R. 9390), a bill that would require hospitals to post pricing physically on their walls; and the Improving Seniors’ Timely Access to Care Act (H.R. 3514), an AHA-supported measure that would reduce variation in prior authorization methods used for Medicare Advantage plans. 
    • “The AHA provided comments to the subcommittee June 10 for a hearing discussing some of the proposals from today’s markup. All of the bills considered June 25 were advanced to the full committee for consideration.”
  • Bloomberg Law informs us,
    • “Out-of-network doctors are winning drastically higher arbitration payouts for planned procedures under a law protecting patients from unexpected emergency bills, according to data from insurer Elevance Health Inc.
    • “Over the last two years, median arbitration awards won by out-of-network doctors for the most common billing codes for planned procedures are 53 times the in-network rate, the insurer said in a paper shared with Bloomberg Law. Elevance said doctors are exploiting a loophole under the No Surprises Act meant to exclude procedures where patients knowingly consent to paying for out-of-network care.” * * *
    • “The No Surprises Act is largely intended to protect patients when they need emergency care at out-of-network hospitals. But it also allows doctors to file arbitration disputes for in-network procedures where the secondary physician, such as an anesthesiologist, is out-of-network. Doctors are prohibited from balance-billing in those situations unless the patient signs a specific waiver acknowledging the additional costs.
    • “Planned procedures made up around 60% of Elevance’s “independent dispute resolution” awards, and the amounts dwarfed those won for emergency care. Overall, arbitration awards for provider groups filing the most disputes are three to nine times higher than in-network benchmarks. Elevance’s data, by contrast, show that doctors performing planned procedures were winning awards 53 times the in-network benchmark rate.”
  • The FEHBlog who represents a payer (not Elevance) in these No Surprises Act cases seconds Elevance’s contention. What’s more an out-of-network primary surgeon can use the No Suprises Act process as long as the surgery occurs in an in-network facility.
  • Per an AHIP news release,
    • “Recent polls show that rising healthcare costs are a top concern for Americans across the political spectrum and voters strongly support common-sense policy solutions to address the root causes driving the healthcare affordability crisis.
    • “New polling data from the Century Foundation underscores the breadth of bipartisan support for policy solutions: 
      • “Two-thirds of voters said that the federal government should make “stop[ping] hospitals from charging excessive prices” their top priority – more than any other policy proposal.
      • “Support for reining in hospitals’ ever-higher prices is decisive across partisan and demographic lines, including 71% of Democrats, 66% of Republicans and 75% of rural voters.
      • “Six in 10 voters said reining in surprise medical billing by providers should be a top priority – the second-highest priority of all proposals tested.
    • “Voters’ bipartisan concerns are well-grounded in the data. Healthcare costs are rising faster than inflation, driven by unchecked growth in the price of hospital care, physician services and prescription drugs. Americans’ premiums and out-of-pocket costs directly reflect these rising costs.”
  • Tammy Flanagan, writing in Govexec, points out, at the conclusion of a longer article
    • “Even as Medicare and FEHB premiums continue to rise, many retirees still find the combination worthwhile when plans include cost-sharing waivers, rebates or Medicare Advantage structures that shift more costs away from point-of-care spending. Higher-income retirees subject to IRMAA face a sharper calculation: higher fixed premiums today versus potential exposure to higher out-of-pocket costs later. For many, the decision is less about optimization than risk tolerance over time.”

From the Food and Drug Administration front,

  • The New York Times reports,
    • “Doctors treating cancer patients nationwide are facing a shortage of essential generic chemotherapy drugs, a situation that many fear could lead to widespread rationing.
    • “The shortages stem from manufacturing problems, shipping delays and decisions by some companies to stop producing the medications, according to the Food and Drug Administration.
    • “The decades-old medicines are challenging to make in sterile plants and command a very low price in the United States. But they are considered among the most effective treatments for some cancers without more targeted options, including some breast, lung, and head and neck cancers. * * *
    • “From a systemwide policy change, not a single thing has changed,” said Laura Bray, the executive director of Angels for Change, a nonprofit that works to alleviate drug shortages. “It’s time for Washington to get involved and help the citizens of the United States ensure that we have lifesaving medicine.”
  • Fierce Pharma relates,
    • “After 35 years of research and development in pharmaceutical products, Ionis began marketing its drugs for the first time in 2024.
    • “While the company’s maiden voyage into commercialization has progressed “remarkably smoothly,” according to CEO Brett Monia, Ph.D., those efforts will now ratchet up to a new level with the FDA approval of Tryngolza to treat severe hypertriglyceridemia (sHTG).
    • “With the nod, Ionis advances from selling two rare disease drugs to marketing a product that could be used by millions of potential patients.
    • There is no other drug on the market designed specifically to treat sHTG or to combat its accompanying bouts with pancreatitis, which can land patients in the hospital for extended stays and be life-threatening.” * * *
    • “In anticipation of the approval, Ionis’ launch team has been in place since February, promoting Tryngolza to endocrinologists, cardiologists and lipid specialists for FCS while also educating them on sHTG.   
    • “The physicians are just chomping at the bit, waiting to prescribe Tryngolza for their sHTG patients since they manage so many of them,” Monia said.” 

From the judicial front,

  • The Wall Street Journal reports,
    • “The [U.S.] Supreme Court on Thursday ruled for Bayer in its fight against claims that it failed to warn consumers that Roundup causes cancer, boosting the company’s efforts to resolve costly litigation over its popular weedkiller. 
    • “In a 7-2 decision, the court said the pharmaceutical and agriculture company can’t be held liable under state law for failing to warn about the alleged risk when a federal regulator—the Environmental Protection Agency—didn’t require the product to carry a warning label.” * * *
    • “In a statement, a Bayer spokesperson said Thursday’s decision was “good for science, farmers, and industries that depend on regulatory clarity for innovation. It should help significantly contain the Roundup litigation after nearly a decade of legal battles.”
    • “It is a significant victory for Bayer Chief Executive Bill Anderson, who took over the German conglomerate in 2023 with a mandate to help steer it through the litigation. Securing a win at the Supreme Court, along with its proposed settlement, are crucial parts of the company’s strategy to finally move past the long-running Roundup litigation woes.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Here’s another reason to cover up in the thick of tick season this summer: There is a bite that can leave you allergic to burgers, bacon and steak.
    • “That’s right—Lyme disease isn’t the only health threat ticks can pose. More people are learning about alpha-gal syndrome, a potentially life-changing allergy linked to the lone-star tick.
    • “The condition triggers a red-meat allergy. In some cases, it also causes an allergy to dairy and other products or medication derived from mammals (think gelatin).
    • “And lone-star ticks are on the move, thanks to climate change and burgeoning white-tailed deer populations. They are moving beyond their traditional base in the Southeast and south-central U.S., pushing farther north and west. 
    • “The ticks are especially common in coastal areas, such as Martha’s Vineyard off the coast of Massachusetts and Suffolk County in New York. And no, despite their name, the ticks didn’t originate in Texas. They are called that because of a single white dot on their backs that looks like a single star.” * * *
    • “An added problem: Some doctors believe cases are still being missed. After all, until recently many healthcare providers knew little about the condition caused by lone-star tick bites.
    • “A 2023 CDC report found that 42% of healthcare providers had limited knowledge of alpha-gal syndrome and 35% weren’t confident in their ability to diagnose it. 
    • “Patients say misdiagnosis of the syndrome is common and diagnoses can be delayed. That’s because allergic reactions often take place three to six hours after eating the culprit. Among common misdiagnoses: irritable bowel syndrome.”
  • Contemporary Pediatrics tells us,
    • “Researchers found evidence that childhood influences may contribute to 85 adult health diagnoses, including tobacco use disorder, heart disease, digestive disorders, and urinary conditions.
    • “Later age at menarche may serve as a marker of childhood environmental or acquired factors that affect long-term health outcomes.
    • “Findings support the need for greater research into childhood determinants of adult disease and potential prevention strategies across the lifespan.”
  • MedPage Today informs us,
    • “Most in-vitro fertilization (IVF) add-on treatments have little to no evidence of benefit.
    • “Many patients rely on social media and IVF clinic websites for information about them, which may be overhyped.
    • “Better information for patients, and trials of benefits and harms of add-ons are needed.”
    • * * * For example, “[f]our add-ons seemed to have no effect on live birth rates:
      • “EmbryoGlue: OR 1.12, 95% CI 0.91-1.37, P=0.29; seven RCTs; low-certainty evidence
      • “Preimplantation genetic testing for aneuploidy: OR 1.16, 95% CI 0.91-1.47, P=0.23; five trials; moderate certainty
      • “Endometrial receptivity testing: three trials; meta-analysis not undertaken; moderate certainty
      • “Corticosteroids: OR 0.95, 95% CI 0.70-1.27, P=0.71; two trials; moderate certainty.”
  • and
    • “Use and misuse of GLP-1 receptor agonists were common in people with eating disorders, interim results of an ongoing cross-sectional study suggested.
    • “Among over 400 people with eating disorders, 32.1% said they have used GLP-1 drugs, and 22% reported current use, wrote Nicholas C. Peiper, PhD, MPH, of the University of Louisville in Kentucky, and co-authors in a research letter in JAMA Psychiatry.opens in a new tab or window
    • “Notably, 10.1% said they have misused the medications, and 9.9% reported using noncommercial compounded products.”
  • Healio notes,
    • “Omega-3 fatty acids may not deliver benefits for cognitive function on their own, according to a study published in eBioMedicine.
    • “The results show the need for a multimodal approach to preventing dementia in older adults, one that simultaneously addresses physical inactivity, vascular health and other risk factors, Hussein Yassine, MD, director of the USC Center for Personalized Brain Health, and colleagues wrote.”
  • Cardiovascular Business lets us know,
    • “Oral nicorandil can reduce the risk of contrast-associated acute kidney injury (CA-AKI) when patients with renal dysfunction undergo percutaneous coronary intervention (PCI), according to new research published in Circulation: Cardiovascular Interventions.[1] The greatest impact was seen in patients receiving three high doses of the medication per day.
    • “Nicorandil is currently indicated for the treatment of angina. Because it is associated with improved hemodynamics in addition to anti-oxidant and anti-apoptotic benefits, the team behind this study hoped to learn more about its potential effect on high-risk PCI patients who present with renal dysfunction.
    • “Researchers focused on more than 600 patients with renal dysfunction who underwent PCI from 2022 to 2025. While approximately one-third of those patients received 5 mg of nicorandil three times per day, another one-third received 10 mg of nicorandil three times per day. The remaining patients received no nicorandil and served as the study’s control group.
    • “Overall, the rates of CA-AKI within 72 hours were 8.7% for the high-dose group, 10.9% for the conventional dose group and 19.8% for the control group. High-dose nicorandil was linked to a 61% relative risk reduction without significantly increasing the risk of adverse events.”
  • Per BioPharma Dive,
    • “Biotechnology startup RQ Bio has snagged a nine-figure funding round to support development of a drug it believes to be capable of providing broad, long-lasting protection against seasonal influenza.
    • “The London-based biotech said Wednesday it raised 85.5 million pounds, or $115 million, to advance a program known as RQB01. Currently in preclinical testing, the therapy has an undisclosed “differentiated dual mechanism” targeting parts of the virus that remain unchanged even after mutations. RQ Bio claims this approach could help ward off flu-related illness from a variety of different strains, with a single dose providing protective effects that persist for a full season.
    • “The financing round was led by Frazier Life Sciences, included participation from founding investor LifeArc Ventures, and involved other well-known firms such as Forbion and EQT Life Sciences.”

From the U.S. healthcare business front,

  • HealthLeaders reports,
    • “PwC projects a 9.0% commercial medical cost trend for group plans in 2027, driven by structural inflators like AI-enabled documentation tools, rising specialty pharmacy costs, and IDR payments. 
    • “As payers aggressively deploy AI-driven pre-payment reviews to combat rising costs, providers are automating their defenses, creating an expensive administrative arms race that fails to lower systemic costs for the consumer.
    • “To navigate this financial squeeze without alienating their communities, health systems must shift away from back-end collections and prioritize transparent, empathetic pre-service financial clearance.”
  • Beckers Payer Issues relates,
    • “Optum is speaking with multiple large New York health systems to sell some specialties in the state, the company confirmed to Becker’s June 24.
    • “The UnitedHealth Group subsidiary is considering the sale of certain specialties, including orthopedics, general surgery and urology. The specialties are affiliated with Optum Medical Care and Crystal Run Healthcare, which Optum purchased in 2023.
    • “We are in discussions with several large health systems across New York regarding the transition of certain specialty services with the goal to keep that care local,” Jon Nasser, MD, CEO of Optum New York and New Jersey, said in a statement shared with Becker’s. 
    • ‘Optum has already signed or is negotiating letters of intent with the interested health systems. The company aims to reach agreements and close sales by the end of 2026.”
  • and
    • “Walgreens will begin supporting eligible Medicare beneficiaries through the new Medicare GLP-1 Bridge program at about 8,000 pharmacies when the initiative launches July 1.
    • “More than 56 million patients in the Medicare network may be eligible for the program, according to a June 25 news release. Walgreens pharmacists will help patients navigate eligibility requirements, answer questions about participating medications and provide ongoing support during treatment. Free delivery will be available in most states for select oral GLP-1 tablets, as well.
    • “Walgreens joins CVS Health, Walmart and Sam’s Club in supporting the Medicare GLP-1 Bridge program. CVS said it will offer expanded pharmacist support, a $49 MinuteClinic virtual weight management visit and a $50 monthly copay option for eligible Medicare beneficiaries. Walmart and Sam’s Club said they will provide pharmacist consultations and educational resources through nearly 5,000 pharmacy locations.”
  • Beckers Hospital Review tells us,
    • “Orlando Health Watson Clinic Lakeland (Fla.) Highlands Hospital is scheduled to open July 8 after more than six years of construction and planning.
    • “The more than $500 million facility is the first hospital opening in Lakeland in over a century, and Orlando Health’s 50th facility in Florida, including clinics, freestanding emergency departments, hospitals, and institutes, according to a June 25 news release shared with Becker’s. 
    • “Orlando Health Watson Clinic Lakeland Highlands Hospital has hired 1,500 employees, and is offering full scholarship programs to full- and part-time staff. The 558,233-square-foot facility has seven floors, 206 patient beds, 49 emergency room beds and sits on nearly 80 acres.
    • “The hospital has eight labor and delivery beds, 28 postpartum rooms and two cesarean section operating rooms. In the next few months, it will open a neonatal intensive care unit that comprises 12 beds for babies who need specialized postbirth care.”
  • Radiology Business adds,
    • “The University of Pittsburgh Medical Center recently held a ribbon cutting for an $8 million new interventional radiology suite. 
    • “UPMC Williamsport, a 224-bed acute care hospital, said the relocated IR facility seeks to bring minimally invasive care closer to home for patients in north central Pennsylvania. The upgraded suite now includes two state-of-the-art labs, equipped with next-generation imaging systems. 
    • “UPMC said the scanners will allow radiologists to visualize blood vessels and internal structures in real time. There, they’ll deliver procedures including stent placements and balloon angioplasties with “greater accuracy and control.” 
    • “This investment reflects UPMC’s ongoing commitment to expanding access to advanced, high-quality care across north central Pennsylvania,” Luke Klingler, director of the health system’s Heart and Vascular Institute, said in an announcement June 17. “The new interventional radiology suite strengthens our ability to meet the evolving needs of our communities by enhancing clinical capabilities, supporting multidisciplinary collaboration, and ensuring patients can receive leading-edge, minimally invasive care close to home.”
  • MedCity News informs us,
    • “Michigan-based insurer Priority Health has teamed up with Garner Health, a digital platform that steers patients to high-performing doctors to lower costs, the companies announced on Wednesday.
    • “Priority Health serves 1.4 million members in Michigan, Indiana, Ohio and Wisconsin. The new partnership will support both self-funded and fully funded employer groups, and will become available starting August 1.
    • ‘The partnership seeks to make it easier for Priority Health’s members to find high-quality physicians in their area. Garner Health has a dataset of over 60 billion medical records that helps identify the best quality doctors. When members choose high-performing providers through Garner’s dataset, their employer then covers most or all of their out-of-pocket costs. This incentivizes employees to choose better doctors and lowers costs for employers by avoiding unnecessary procedures.”
  • Per Fierce Healthcare,
    • “Virtual care platform First Stop Health unveiled an expansion of its Healthy Weight Program amid increasing GLP-1 demand and subsequent healthcare plan costs.
    • “The program integrates weight management, including GLP-1 prescriptions when appropriate, directly into its primary care model. New to the program is a cash-pay access option for employers who do not currently cover GLP-1 prescriptions and a managed coverage program for those who do offer coverage. 
    • “The goal isn’t simply weight loss — it’s improving metabolic health and reducing long-term health risk,” said Cole Barfield, M.D., First Stop Health chief medical officer, in an emailed statement to Fierce Healthcare. 
    • “Barfield said the virtual care platform aids “employers on either side of the coverage decision” by “combining clinically appropriate prescribing with primary care, dietitians, health coaches, and diabetes educators who support sustainable behavior change.” 
    • “Medication can be transformative, but it works best when it’s part of a real care relationship focused on the whole person,” Barfield said.”

Thursday report

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

Simplicity is a virtue.

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

From Washington, DC.

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Weekend Update

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

Simplicity is a virtue.

From Washington, DC,

  • The Hill reports,
    • “The Supreme Court is in its final sprint.
    • “President Trump’s agenda is on the line as the justices dash to hand down their remaining decisions by their self-imposed deadline of the end of June. 
    • “With 20 argued cases left, the court’s pace is exactly on par with this time last term. 
    • “But among those remaining cases are potentially seismic decisions on birthright citizenship, presidential firing power, transgender athletes, mail ballots and more. 
    • “The next opinions are expected Thursday.”
  • FedScoop reports,
    • “The Trump administration is already trying to bring talent from industry into the government via its U.S. Tech Force program, but the next step could be putting federal workers on exchanges to companies, according to remarks from an Office of Personnel Management official Thursday.
    • “During a panel at a federal technology-focused conference, Kevin Hennecken, senior advisor to the director at OPM and leader of the Trump administration’s Tech Force hiring effort, mentioned the agency’s interest in such a program as a way of helping train federal workers. 
    • “Something OPM has been focused on is “creating more pathways for people to sort of experiment going to the private sector for periods of time and coming back,” Hennecken said. “I think that can also be quite helpful, just to expose them to some different ways of getting things done.”
  • Per a June 11, 2026, HHS news release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), today announced $40 million in funding opportunities for eight grant programs that will advance President Trump’s Great American Recovery Initiative by preventing addiction, strengthening the behavioral health workforce, and supporting efforts to address mental illness and prevent suicide.”

From the Food and Drug Administration front,

  • Fox Business reports,
    • “The Food and Drug Administration (FDA) has classified a recall of more than 900 cases of Alfredo sauce at its highest risk level after a supplier recalled a dry milk powder ingredient used in the product due to potential salmonella contamination.
    • The FDA designated the recall as a Class I event, its most serious classification, meaning there is a reasonable probability that use of or exposure to the product could cause serious adverse health consequences or death.
    • The recall affects 913 cases of Alfredo sauce packaged in 3-pound, 7-ounce sealed poly bags and 12 bags per case, according to an FDA enforcement report.
  • STAT News relates,
    • “The Food and Drug Administration on Friday approved teplizumab, a type 1 diabetes drug developed by Sanofi, for children aged 8 and older with stage 3 diabetes. 
    • “The drug was selected to go through a speedy review program launched last year by former FDA Commissioner Marty Makary, but the agency missed its goal date of April 21 to deliver a decision.” * * *
    • “Teplizumab, or Tzield, is a monoclonal antibody that aims to delay the progression of type 1 diabetes. The FDA first approved the drug to delay the onset of stage 3 diabetes in adults, and in children ages 8 and older with stage 2 disease. In April, the FDA expanded that approval to allow children as young as 1 year old to take the medication.
    • “The FDA cleared the drug under the accelerated approval pathway based on the surrogate endpoint of higher C-peptide levels. Sanofi will have to verify and describe clinical benefits for type 1 diabetes patients in follow-up studies.” 

From the judicial front,

  • Fierce Healthcare reports,
    • “On the heels of a legal challenge from CVS, Express Scripts has also sued to challenge Tennessee’s new pharmacy benefit management law.
    • “Under the law, PBMs would be barred from also owning pharmacies in the state. In its complaint, Express Scripts says that policy would not just impact retail pharmacies but would force its parent company, Evernorth, to shutter an Accredo specialty pharmacy center based in Memphis.
    • “Closing that facility, the company said, could cost thousands of jobs. And broadly speaking, the law could lead to pharmacy deserts in rural areas, where more than a third of its residents currently live.
    • “It could also limit access to home delivery services, the PBM said. Express Scripts Pharmacy shipped more than 2 million prescriptions to people in the Volunteer State last year alone.
    • “Other services that could be impacted by the law include fertility pharmacies, through which Express Scripts affiliates supported thousands of Tennesseans, the company said.
    • “Express Scripts argues that “shortsighted law” is unconstitutional and cannot be enforced, according to an announcement.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “A relentless measles outbreak in Utah has been spreading for nearly a year, putting the U.S. on a path to losing the measles-elimination status it earned more than two decades ago. 
    • “Fueling the nearly 12-month outbreak: more parents opting not to vaccinate their children for school; infections hitting communities statewide; and lenient public-health policies on quarantining exposed students.
    • “Utah’s streak of 679 cases is the latest and longest-lasting of a series of measles outbreaks in the U.S. since early last year. The Centers for Disease Control and Prevention is in the process of assessing whether any outbreaks lasted more than 12 months, which is a determinant of whether the U.S. would lose its status as a country that eliminated measles as of 2000.
    • “State health officials suspect there has been continuous spread since at least August. Utah’s outbreak has proved trickier to stop than other recent streaks of measles cases.” 
  • Medscape tells us,
    • “In adults with obesity and without diabetes, using GLP-1s vs other antiobesity medications was significantly associated with a decreased risk for osteoporosis, major osteoporotic fractures, degenerative disk disorders, and osteoarthritis.” * * *
    • “GLP-1s are uniquely positioned to achieve sustained weight loss without compromising — and possibly enhancing — bone integrity. They may be particularly suitable for individuals with preexisting risk factors for osteoporosis or degenerative joint disease, in whom other obesity agents may exacerbate skeletal fragility. Incorporating bone health assessment into obesity management may aid in optimizing therapeutic selection and improving comprehensive patient care,” the authors wrote.”
  • Healio informs us,
    • “At 2 years, crinecerfont demonstrated favorable effects on weight, body composition and insulin resistance in adults with classic congenital adrenal hyperplasia, researchers reported at ENDO 2026.
    • “In addition, crinecerfont (Crenessity, Neurocrine Biosciences) was associated with stable or improved bone age progression in children and adolescents with classic congenital adrenal hyperplasia (CAH), according to results from another ENDO 2026 presentation.”
  • and
    • “In patients with obesity, exercise as assessed by wearable-measured activity declined after they initiated GLP-1 receptor agonist therapy, according to findings presented at ENDO 2026.
    • “GLP-1 receptor agonists are now used by millions of adults for weight loss, and we know from prior work that exercise is critical for preserving lean muscle and sustaining long-term weight reduction,” Sajana Maharjan, MD, from the department of internal medicine at HSHS St. John’s Hospital in Springfield, Illinois, told Healio. “What was missing was an objective answer to a basic question: Do patients actually become more active as they lose weight on these drugs? Most prior studies relied on self-reported activity. The NIH All of Us Research Program, which links electronic health records with Fitbit data, gave us a chance to answer that question with wearable-measured activity in the same patients before and after starting therapy.” * * *
    • “Exercise needs to be actively prescribed alongside GLP-1 therapy, not assumed to follow from weight loss,” Maharjan told Healio. “Practically, that means structured exercise counseling at the time of initiation, a strong emphasis on resistance training to protect lean muscle, and physical therapy or pain management referrals for patients with joint or muscle pain. Our findings also suggest that men may need more targeted support, since they showed the steepest declines. Wearables themselves can play a useful role in tracking progress and keeping activity goals in front of patients over time. GLP-1 medications reduce not only fat but also lean muscle mass, which makes maintaining physical activity even more important during treatment. Patients who lose weight without staying active risk losing strength and function alongside the fat loss they came in for.”
  • and
    • “In patients being treated for hypertension, those taking a GLP-1 receptor agonist had higher rates of hypotensive events compared with those not taking one, researchers reported at ENDO 2026.
    • “I began to notice multiple patients in clinic who were started on GLP-1s (by me and others) who were complaining of lightheadedness, dizziness and fainting. They had low blood pressure on my examination,” Micah J. Eimer, MD, associate chief medical officer in the division of cardiology at Northwestern Medicine, told Healio. “Hypotension is the most dreaded potential side effect of treating hypertension and actually far more dangerous. The results were confirmatory to our clinical suspicion.” * * *
    • “Eimer told Healio that “blood pressure needs to be monitored in patients who are taking GLP-1s at the initiation of therapy and during dose escalation. Patients should also be warned about signs of low blood pressure so that they can report them. I am particularly worried about the risk to patients who obtain GLP-1s without direct and ongoing clinical supervision.”
  • The Wall Street Journal point out,
    • “New research indicates the brain can truly multitask by rewiring its circuitry with practice.
    • “A study in the Journal of Cognitive Neuroscience showed participants’ brains could automate tasks by offloading them from the prefrontal cortex to the temporal cortex.
    • “Automation requires extensive repetition, making effortful tasks easier and less attentionally demanding, study co-authors said.”
  • Per Fierce Pharma,
    • “In a plenary session at the 2026 European Hematology Association (EHA) annual meeting in Stockholm, Johnson & Johnson brought to the world stage a reminder of its status as a leading developer of multiple myeloma treatments. 
    • “The company spotlighted results from its MonumenTAL-3 phase 3 study, which added its GPRC5D bispecific antibody, Talvey, to the mainstay melanoma drug Darzalex Faspro in patients with relapsed or refractory multiple myeloma who had tried at least one prior line of therapy. When used with or without Bristol Myers Squibb’s Pomalyst (pomalidomide), the regimen cut the risk of disease progression or death by up to 72% and proved a clinically meaningful reduction of up to 53% in the risk of death compared with standard Darzalex Faspro, Pomalyst and dexamethasone (DPd), J&J said in a June 13 press release. 
    • “The trial showed a progression-free survival rate of up to 81.3% for the Talvey combos after 24 months compared with the standard-of-care regimen’s 51.2%, and an overall survival rate of up to 89.2% compared with 79.1% for DPd.”

From the U.S. healthcare business,

  • The Wall Street Journal reports on the future of healthcare technology.
    • “New scientific advances are poised to shift healthcare toward earlier disease prediction and prevention within the next five to 10 years.
    • “Blood tests, AI tools, and GLP-1 drugs are emerging for early detection and prevention of Alzheimer’s and heart disease.
    • “New therapies aim to regenerate damaged joints for arthritis and detect breast cancer recurrence earlier using circulating tumor DNA.”
  • MedCity News relates,
    • “Ascendiun CEO Paul Markovich recently launched a national policy reform movement called Worthy. During an interview at AHIP 2026, he shared four key policy efforts that Worthy is promoting.
      • “1. Digital health records: Markovich is proposing getting every American a comprehensive, real-time digital health record that can personalize their care. He said this would save over $300 billion in administrative costs throughout the system. Much of the healthcare system is currently run on outdated technology and fax machines.
      • “2. Change the way healthcare is paid for: The healthcare industry needs to transition to paying for outcomes versus the fee-for-service model.
      • “3. Make prescription drugs affordable: The price of pharmaceutical drugs has been growing at levels that aren’t sustainable for the public, Markovich said. He called for efforts to ensure intermediaries aren’t rewarded for selling a higher volume of more expensive drugs.
      • “4. Put the healthcare system on a budget: Markovich is calling for putting healthcare organizations on a budget and implementing financial consequences for missing budget targets. He argued that hospitals, in particular, are paid more to do more, incentivizing them to conduct more tests, scans, keep people overnight, etc. This eventually leads to more inflation. Instead, Markovich proposes reimbursing hospitals a fixed amount on a monthly basis and adjusting it for the risk of the population and the size of the population.”
  • and
    • “Rocket Pharmaceuticals sold its rare disease pediatric priority review voucher for $180 million, cash that the company will use to support a pipeline now led by a gene therapy in development for a rare, inherited disease with no FDA-approved therapies.
    • “Rocket announced the voucher sale on Friday. The Cranbury, New Jersey-based gene therapy developer did not disclose who purchased the voucher, saying only in a regulatory filing that the buyer was “a large pharmaceutical company.”
    • “The FDA awarded the voucher in March alongside the accelerated approval of Rocket’s Kresladi, the first gene therapy for leukocyte-adhesion deficiency type 1 (LAD-1), an inherited immunodeficiency that can become fatal to babies. Such vouchers may be applied to another eligible rare disease therapy, cutting the standard 10-month review down to six months. But vouchers are transferable and many recipients choose to sell them.”
  • A commentator observes in MedCity News,
    • “In the Age of AI, Interoperability Isn’t Enough: Why Healthcare Needs Shared Understanding, Not Just Shared Data.”
    • ‘The industry needs a framework that can translate clinical nuance into a consistent, trusted representation across systems and use cases.” * * *
    • “Today, we rely on localized definitions of quality and accuracy shaped by providers’ current manual coding guidelines, individual workflows, and historical practices. The result is predictable: subjectivity. Agreement on accuracy across coders hovers around 50%, even among experienced and fully certified coders. In that environment, interoperability alone cannot deliver alignment.
    • “What is needed is a layer above interoperability, an objective framework for context and quality that establishes shared understanding. This framework does not eliminate variation; it normalizes it, creating a consistent and trusted output across clinical, operational, and financial use cases.
    • “Also, the framework must be uniformly administered. Acting as a compliance engine, this layer ensures that codes are not only technically correct but appropriate across use cases, clinical, financial, and analytical. When that standard is met, codes become more than billing artifacts; they become a reliable representation of patient history and a consistent entry point into the broader clinical record, regardless of where the data originated. Over time, this reduces friction across the system, including audits, denials that are ultimately reversed, and the burden of prior authorization.”