Thursday report

Federal employment benefits

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.” 

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.”

Midweek report

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

Simplicity is a virtue.

From Washington, DC,

  • Per a Senate news release,
    • “On Wednesday, July 15, [beginning at 10 am ET], the U.S Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a confirmation hearing on the nomination of Sean Kaufman to be Assistant Secretary for Preparedness and Response for the U.S. Department of Health and Human Services and Erica Schwartz to be Director of the Centers for Disease Control and Prevention.”
  • The Wall Street Journal reports,
    • “Rates for many Affordable Care Act plans rose by double digits this year. Insurers want to do the same next year.
    • “Some of the biggest Obamacare companies are seeking hefty premium increases for 2027, often for the second year in a row. In Washington state, Centene is asking for a 28% hike, after boosting rates by 35% in 2026. Blue Cross and Blue Shield of Illinois wants 15%—on top of a 28% increase this year.
    • “It is a stunning jump” when you add both years together, said Cynthia Cox, senior vice president at KFF, a health-research nonprofit. At the request of The Wall Street Journal, KFF analyzed the rate requests for the largest ACA plans by enrollment in 15 states where insurers’ 2027 filings have already become public, as well as the District of Columbia.” * * *
    • “KFF calculated the median increase across 77 publicly available ACA rate filings for 2027: 14%. For 2026, the median final rise across all ACA plans was 20%.   
    • “Insurers’ 2027 ACA rates have to be reviewed by regulators, and the premiums finalized in late summer might be different from these early requests.”
  • Beckers Payer Issues reports,
    • “CMS has rescinded a decade-old “fast-track” review process for certain Medicaid Section 1115 demonstration waiver extensions as the agency prepares to implement new federal budget neutrality requirements that take effect in 2027.
    • “The July 7 informational bulletin formally withdraws 2015 guidance that allowed eligible states to use an expedited review process when renewing some Section 1115 demonstrations.
    • “CMS said the change is necessary because new statutory requirements will require the agency’s chief actuary to certify that Medicaid demonstrations will not increase federal spending before they can be approved, renewed or amended beginning Jan. 1, 2027.” * * *
    • “CMS previously notified state Medicaid directors that it intends to propose new budget neutrality policies and expects to issue additional implementation guidance. The agency said it remains committed to working with states to support Medicaid and CHIP innovation while complying with the new statutory requirements.”
  • Federal News Network relates,
    • “The Trump administration is looking to tweak the rules for federal employees’ paid administrative leave. Recently proposed regulations from the Office of Personnel Management would give agencies more leeway to use paid leave, including during workforce reduction efforts. During 2025, agencies used administrative leave to implement the deferred resignation program, choosing to paying thousands of employees for several months not to work, in exchange for them agreeing to quit their jobs.”
  • and
    • Federal News Network interviews Tammy Flanagan about early retirement for federal law enforcement officers.
      • [I]n law enforcement, typically, you’ve got to retire by the time you’re 57. And sometimes that’s hard because they really love that career for the most part, and that’s their identity. So leaving that early sometimes can be a tough transition, not only financially, but also emotionally.
  • The American Hospital Association News informs us,
    • “The Department of Health and Human Services and the Centers for Medicare & Medicaid Services July 8 launched  a voluntary pledge that hospitals can sign related to their efforts on healthy food. Among other actions, the pledge asks that hospitals prioritize food options in alignment with the 2025-2030 Dietary Guidelines for Americans; ensure that inpatient meals meet individual nutritional needs; provide accessible nutrition education and resources to sustain healthy habits following discharge; and provide community-based nutrition programs to support healthier communities.” 

From the Food and Drug Administration front,

  • STAT News reports,
    • “The top contenders to lead the Food and Drug Administration have been sent to the White House for a final review and decision, according to a person familiar with the process.
    • “The finalists include Heidi Overton, a White House adviser; Jeffrey Vacirca, an oncologist and health system executive; and Stephen Ferrara, a health affairs official at the Defense Department.” * * *
    • “The advancement of the finalists suggests the highly anticipated decision is on the horizon, though the timing remains unclear.”
  • Politico discusses the FDA’s 2026 regulatory agenda which was released on July 3.

From the judicial front,

  • HealthExec reports,
    • “Once scheduled for the fall, the federal murder trial against the man accused of killing UnitedHealthcare CEO Brian Thompson will now begin in January, a judge determined last week.
    • “At the conclusion of a June 29 hearing, U.S. District Judge Margaret Garnett agreed with attorneys representing Luigi Mangione who argued the original date of Oct. 13 left little time to prepare a defense.
    • “A trial in New York on state charges of second-degree murder is set to begin first, with jury selection pegged for a Sept. 8 start date, followed by opening arguments on Oct. 13—the same day the federal trial was initially scheduled to begin. With it now pushed back, Mangione’s attorneys need only worry about the looming prospect their client could be spending the rest of his life in prison as a result of the first trial.”
  • Per a Justice Department news release
    • “The founder and former Chief Executive Officer (CEO) Ruthia He of Done Global Inc., a California-based digital mental health company, was sentenced today to six years in prison and a fine of $1 million for orchestrating a scheme that used her company’s technology platform, compensation structure, and clinical protocols to unlawfully distribute over 37 million pills of Adderall, defraud insurers of over $12 million, and obstruct the federal investigation that followed.”

From the public health and medical / Rx research front,

  • The Hill reports,
    • “As of Monday [July 6], the parasitic illness has spread to at least 18 states, with the most cases reported in Illinois, Michigan, New York and Texas.
    • “While exact numbers are unknown, the Michigan Department of Health and Human Services has reported 572 cases of cyclosporiasis as of July 4, and New York has reported more than 100. No exact numbers have been released for Illinois or Texas. Current figures are most likely an undercount, as most people who are sick don’t report it or go to a doctor unless it’s severe.
    • “Other states linked to the outbreak include Alaska, Colorado, Connecticut, Florida, Georgia, Louisiana, Massachusetts, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Virginia and Wisconsin.”
  • Health Day relates,
    • “Exercise can boost a smoker’s odds of successfully quitting, a new evidence review says.
    • “Smokers taking part in exercise programs were more likely to either quit or cut back on cigarettes, researchers reported recently in the Journal of Sport and Health Science.
    • “In fact, a single bout of exercise immediately reduces nicotine cravings for up to a half hour afterward, researchers found.
    • “Quitting smoking is one of the best things a person can do for their health, but it’s also one of the hardest,” lead investigator Ben Singh, a research fellow at Adelaide University in Australia, said in a news release.
    • “Many smokers want to quit, but the current approaches don’t work for everyone,” Singh said. “That’s why we need more strategies that people can incorporate into their daily lives at little or no cost.”
  • The New York Times discusses the medical problems created by parents refusing to protect their infants with an injection that resolves the Vitamin K deficiency with which all of us are born. It’s worth a read.
  • STAT News tells us,
    • “Could a lifesaving lung transplant strategy that contained the Covid-19 virus also save patients whose advanced lung cancer hasn’t spread? 
    • “That’s the question that inspired surgeons and oncologists at Northwestern Medicine to offer double lung transplants to patients who had run out of treatment options but whose late-stage cancer hadn’t left their lungs. People with late-stage lung cancer have not been transplant candidates before for two reasons: rates were high for cancer recurrence and low for survival.
    • “There are ethical considerations to weigh, too, when deciding how to allot donated organs.
    • “On Wednesday, the Northwestern team reported in JAMA that the 17 patients who received lung transplants after advanced but limited cancer fared better than 81 similar patients who continued standard immunotherapy, chemotherapy, or radiation treatments. Overall, the study followed 404 patients with end-stage pulmonary disease, including 98 with stage 4 lung cancer.
    • “After one year, through June 2025, all the lung cancer transplant patients had survived compared to 88% of patients transplanted without cancer. Among those 17 patients, by January 2026, there were four recurrences of cancer and two deaths unrelated to cancer — one from an infection and one from a blood clot. Among the 81 cancer patients getting standard care, 74 saw their cancers progress.”
  • Genetic Engineering and Biotechnology News informs us,
    • “It has long been known that brain gray matter plays a key role in multiple sclerosis (MS) disease progression and cognitive impairment, but because magnetic resonance imaging (MRI) has only been able to detect lesions in white matter, neither clinicians nor researchers have had a way to detect or monitor gray matter (cortical) lesions. And while many new drugs developed in the past decade can slow disease progression significantly, they primarily work on reducing white matter lesions.
    • “A University at Buffalo (UB)-led team now reports that it has found a way to use artificial intelligence to reveal these otherwise invisible cortical lesions by reviewing existing MRI scans. The researchers say the significance of finally being able to see what has been known as one of the most important indicators in MS disease progression cannot be overstated.”
  • Healio points out,
    • “Public health messaging had a longer-lasting impact on parents’ intent to vaccinate their children against HPV than AI chatbot interactions.
    • “Strategies to make both modalities more effective are needed.”
  • Per Fierce Healthcare,
    • “After thriving in the market for more than a decade as the only treatment for Dupuytren’s contracture and Peyronie’s disease, Keenova Therapeutics’ Xiaflex has excelled in a phase 3 trial that could set up the injectable biologic enzyme for approval in a third indication.
    • “The study of 436 patients with plantar fibromatosis achieved its primary endpoint, showing statistically significant and clinically meaningful reductions in pain versus placebo as measured by the Average Daily Pain Intensity on the Numeric Rating Scale (NRS).” * * *
    • “Plantar fibromatosis, which is also known as Ledderhose disease, causes lumps composed primarily of excess collagen to form in the connective tissue that supports the arch of the foot. It can cause pain, swelling, and difficulty walking. Based on claims data and projections, Keenova estimates that 300,000 people will see a healthcare provider for plantar fibromatosis in 2028.
    • “There is no medicine on the market specifically for plantar fibromatosis. Patients can get relief through radiation therapy or corticosteroid injections, with surgical interventions generally reserved as a last resort.” 
  • The Wall Street Journal reports,
    • “Some patients are using GLP-1 drugs to treat eating disorders like bulimia and binge-eating disorder.
    • “No major medical organization has endorsed GLP-1s for eating disorders, and drugmakers Novo Nordisk and Eli Lilly say they are not approved for this.
    • “Experts say widespread adoption is unlikely soon due to limited scientific data.”
  • Per MedTech Dive,
    • “Penumbra said Tuesday it has started a clinical trial that could support wider use of mechanical thrombectomy in a subset of stroke patients.
    • “The real-world prospective study is assessing Penumbra’s RED reperfusion catheter portfolio in patients with M2 occlusions.
    • “Penumbra, which Boston Scientific has agreed to buy for $14.5 billion, is assessing whether its computer-assisted vacuum thrombectomy and modulated aspiration tools improve outcomes.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “A newly released audit of UnitedHealth’s home visits for Medicare seniors found little evidence to support accusations that the program, called HouseCalls, drums up extra patient diagnoses to inflate UnitedHealth’s reimbursement from the federal government.
    • “UnitedHealth argued that the results vindicate HouseCalls, which has faced scrutiny from regulators and lawmakers focused on combating profiteering in Medicare Advantage, Medicare’s privatized sister program.
    • “About 96.6% of diagnoses that UnitedHealth found during the home visits were backed up by patients’ health records, according to the audit released Tuesday from FTI Consulting, which used the same review process as the government.
    • “That leaves 3.4% of diagnoses unsupported by medical information — three times lower than the error rate found by the CMS in its most recent audit of data in the privatized Medicare program.
    • “UnitedHealth said it reviewed FTI’s findings and that the lion’s share of diagnoses unsupported by medical records were backed up by other information like paid claims.”
  • and
    • “Data from consumer wearables are valuable in clinical care, and many physicians are using the information in their practice — but widespread adoption is hindered by limited workflow integration and other barriers, according to a survey published Wednesday by the American Medical Association. 
    • “Eighty-six percent of U.S. physicians reported they at least sometimes reviewed data from their patients’ wearables, like information on heart physiology, oxygen and breathing, and sleep, according to the report, which also interviewed doctors from Canada, France, Germany, Spain and the U.K.
    • “But only 6% of doctors in the U.S. said wearable data was integrated into clinical workflows, like the ability to import information into electronic health records. “We have all this data that’s available, but it’s actually not actionable because we don’t have a way to get it into clinical workflow,” AMA CEO Dr. John Whyte said in an interview.”
  • Modern Healthcare relates,
    • “Health insurance companies and third-party vendors offer arrangements to mitigate the costs of cell and gene therapies to employers.
    • “More than three-quarters of employers see gene therapies as a major challenge, yet 35% lack financial protection, a survey found.
    • “The Food and Drug Administration has approved cell and gene therapies for conditions such as blood cancers and neurodegenerative diseases.”
  • MedCity News adds,
    • “In Oncology, the Cost Problem Goes Beyond Predictability.
    • “Healthcare does not lack the data needed to better understand oncology costs. What it does lack is a consistent way to connect clinical progression with financial impact in a time frame that aligns with strategic planning.”
  • Beckers Payer Issues tells us,
    • “Memorial Hermann Health System plans to shut down its commercial health insurance business.
    • “The wind-down affects the Houston-based system’s HMO, PPO, and self-funded products for employers. On its website, the system said it would be difficult to reach the scale needed to sustainably provide value to members moving forward. The closure notice does not include the system’s Medicare Advantage business.
    • “This decision was made following a careful and comprehensive assessment of system assets and resources, including an evaluation of existing opportunities and future challenges amid sustained pressures on health system-owned health plans,” the system wrote.
    • “Current coverage will remain in effect, and providers can continue treating members through each plan’s termination date, which will vary by employer group. Groups whose plan year is set to renew before Dec. 1 will have the option to enroll in one additional year of coverage before the full closure.”
  • and
    • “Josh Michelson started serving as executive vice president and chief strategy and innovation officer for The Cigna Group, according to a recent LinkedIn post.
    • “A Cigna website said Mr. Michelson is responsible for steering the company’s long-term strategic direction, corporate innovation and The Cigna Group Ventures, the company’s venture capital branch.
    • “He joined Cigna in 2020 and was most recently a senior vice president and chief strategy and transformation officer for the company.”
  • Beckers Health IT notes,
    • “[The major electronic health records company] Epic named four executives who will take on expanded responsibilities following President Sumit Rana’s departure, according to a statement from Founder and CEO Judy Faulkner shared with Becker’s.
    • “Ms. Faulkner said Seth Howard, Mark Lipsky, Erv Walter and Garrett Adams are among a small group of leaders who will be adding to their responsibilities as the company moves forward without Mr. Rana.
    • “The statement did not detail the additional responsibilities these individuals would be taking on.” * * *
    • “Mr. Rana’s departure leaves a notable gap at the top of the nation’s largest EHR vendor. He was widely viewed as a potential successor to Ms. Faulkner, who is 82.”
  • Per Cardiovascular Business,
    • “Novo Nordisk is now working with Vivani Medical, a California-based biopharmaceutical company, to evaluate the potential of a long-lasting semaglutide implant. This is a non-exclusive agreement between the two companies. 
    • “Novo Nordisk, one of the world’s largest pharmaceutical companies, sells semaglutide under the brand name Wegovy. Vivani is known for its drug implants, which are designed to help patients benefit from life-changing medications without ever needing to inject or ingest them. 
    • “The goal of this partnership is to reduce the risk of non-adherence and ensure patients taking semaglutide can receive the care their physicians have determined they need. The implant in question, currently known as NPM-139, is being developed to help patients with chronic weight management. It utilizes Vivani’s proprietary NanoPortal technology and could help patients receive the maximum benefits of treatment with just one or two treatments per year.
    • “Vivani is also preparing the launch of a new first-in-human clinical trial that would randomize certain patients to either undergo treatment with an NPM-139 implant or receive semaglutide injections.”
  • Per MedTech Dive,
    • “Resmed has agreed to sell its MatrixCare software business for $490 million to private equity firm Frazier Healthcare Partners. The deal is meant to sharpen Resmed’s focus on sleep and breathing health devices and connected, home-based care.
    • “Divesting MatrixCare enables Resmed to reallocate capital and resources toward higher-growth opportunities and expansion of its digital health ecosystem, the company said Tuesday.
    • “The cash transaction is expected to close in the first quarter of Resmed’s fiscal 2027, which ends in September.”

Monday report

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

Simplicity is a virtue.

From Washington, DC,

  • STAT News reports,
    • “Clinical trial policy got caught up in the Trump administration’s attack on policies related to diversity, equity, and inclusion. Republicans in Congress would like to change that. 
    • “Days after Trump took office, the Health and Human Services Department began purging all references to DEI from the websites of its agencies. Those efforts were supposed to target DEI initiatives focused on hiring practices, communications, and social issues.
    • “But supporters of clinical trial diversity say the policy has nothing to do with DEI in that sense. Instead, it aims to ensure that clinical trials enroll people who are similar to the patients who would use the drugs and medical devices being tested. 
    • “Congressional Republicans seem to agree. Last month, the Republican-controlled House passed a bill, mostly along party lines, to fund the Food and Drug Administration. It was accompanied by a report that, while not legally binding, tells agency officials what congressional appropriators expected of them. 
    • “A section of that bill deals with trial diversity.
    • “The Committee encourages FDA to continue to implement legislation and policies requiring study sponsors to submit a diversity action plan for phase 3 studies of new drugs,” the report states.”
  • MedPage Today relates,
    • “I still have hope,” said Peggy Tighe, legislative counsel for the Regulatory Relief Coalition, a group of physician specialty organizations advocating for regulatory burden reduction in Medicare, when she was asked about the Improving Seniors’ Timely Access to Care Actopens in a new tab or window, which was approved last weekopens in a new tab or window by the House Energy and Commerce Health Subcommittee.
    • “The measure, which seeks more transparency and accountability from Medicare Advantage plans on their prior authorization decisions, must still be approved by the full Ways & Means and House Energy & Commerce committees before it hits the House floor for a vote.
    • “What’s different this year is that there is much more limited committee time and House floor time because of the … drama on the House floor and the paucity of votes,” Tighe said in a phone interview with MedPage Today. “So with everything else going on, I still have hope that we could pass this bill out of Energy & Commerce and Ways & Means before the August recess, but every day that Congress gets canceled, it makes it more difficult to find that time to accomplish what I think should be a very easy goal of passing legislation that is zero cost and widely supported.”
  • Per a 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 more than $281 million in funding opportunities for 15 grant programs.
    • “The investments will advance President Trump’s Great American Recovery Initiative by expanding access to a wide range of behavioral health services, including substance use disorder treatment, overdose prevention and response, mental health and suicide prevention, trauma-informed care, integrated care, recovery supports, first responder training, privacy education and workforce development.”
  • The American Hospital Association tells us,
    • “The AHA today sent a letter to the Office of the United States Trade Representative to ask that medications, medical devices and other healthcare equipment and supplies be exempted from proposed duties on goods from other nations. While “America’s hospitals and health systems support the administration’s goal of strengthening domestic manufacturing for drugs, medical devices, PPE and other essential medical supplies,” the AHA noted, “the U.S. healthcare system relies significantly on international sources for many drugs, devices, supplies, equipment and other products needed to both care for patients and protect our healthcare workers.”
  • Federal News Network informs us,
    • “An overhaul to the federal workforce’s performance management system is now set in stone, following a final rule the Office of Personnel Management released this week.
    • “Going forward, agencies will be limited in the share of employees they can rate highly in performance reviews. OPM’s final regulations, which are scheduled to publish Tuesday to the Federal Register, remove a previous ban on using forced distribution in the government’s performance management system.
    • “The final rule marks the largest overhaul of the government’s performance management system in decades. Agencies will have to be in compliance with OPM’s changes by Jan. 1, 2027. Once effective, the changes to performance management will apply across virtually the entire federal workforce.
    • “These changes are necessary to promote a culture of accountability and excellence across the federal workforce — one that reflects both the government’s evolving operational demands and its longstanding commitment to a merit-based civil service,” OPM said in the final rule.”
  • Other health plan related highlights from last Friday’s unified regulatory agenda.
    • A proposed rule [RIN 0938-AV95, to be published in December 2026] would propose requirements under the Mental Health Parity and Addiction Equity Act (MHPAEA) to clarify plans’ and issuers’ obligations, promote compliance, and reduce burden.
    • A long term plan [RIN 0945-AA22] to modify the Security Standards for the Protection of Electronic Protected Health Information (the Security Rule) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). These modifications will improve cybersecurity in the health care sector by strengthening requirements for HIPAA regulated entities to safeguard electronic protected health information to prevent, detect, contain, mitigate, and recover from cybersecurity threats. A final rule is expected to be published in July 2027.

From the public health and medical / Rx research front

  • The Washington Post explains “Why U.S. measles outbreaks have grown harder to extinguish.”
    • The nation is already nearing last year’s record case total, and experts say the virus is forcing doctors to relearn a disease many thought had been consigned to history.”
  • Beckers Hospital Review tells us that “Clinical cases of the drug-resistant fungus Candida auris more than doubled in the U.S. from 2022 to 2024, highlighting ongoing transmission in healthcare settings, according to a CDC study published July 2.” 
    • “C. auris is frequently resistant to antifungal drugs, can persist on patients’ skin and surfaces, and spreads readily in healthcare settings. Bloodstream infections caused by the fungus are associated with high mortality.
    • “The CDC said sustained infection prevention and control measures, including transmission-based precautions, environmental disinfection and communication of patients’ Candida auris status during transfers, remain essential to limiting further spread.”
  • The AP informs us,
    • “Doctors and others are sounding an alarm: More U.S. children have been drowning in recent years.
    • “When drowning occurs, seconds matter,” said Dr. Rohit Shenoi, the lead author of a recent American Academy of Pediatrics warning. “Quick rescue and resuscitation can mean the difference between life, death and lifelong disability.”
    • “About 4,000 to 5,000 Americans drown each year. Most are adults who die in natural bodies of water, such as lakes, ponds or oceans.
    • “But statistically speaking, drowning is a much larger danger to children. It’s the No. 1 cause of death for kids ages 1 to 4, and one of the top killers of children ages 5 to 14. The drowning rate is higher for white kids in the younger group, but much higher for Black, American Indian and Alaska Native children in the older group.
    • “Drownings of very young children sometimes occur in bathtubs. But most, like Stewie Leonard’s, occur in swimming pools.”
  • The American Medical Association lets us know what doctors want their patients to know about sunburn.
    • “Sunburns cause lasting skin damage. Learn the difference from sun poisoning, how to prevent burns and treat symptoms safely, and when to seek medical care.”
  • Health Day points out,
    • “Many people with long COVID suffer from “brain fog,” finding it difficult to remember things, think on their feet or pay attention.
    • “But this symptom can be addressed by rehab, according to a new study.
    • “Ten weeks of cognitive rehabilitation helped long COVID patients lift much of their brain fog, allowing them to achieve goals they’d set in their work and home lives, researchers reported July 1 in JAMA Network Open.”
  • Beckers Hospital Review notes,
    • “Active drug shortages in the U.S. climbed to 223 in the first quarter of 2026, the second consecutive quarterly increase. Buried in that count are dozens of manufacturer-specific dates — extended-use deadlines, promised “next delivery” windows, backorder recovery targets — that pharmacy teams are tracking lot by lot. Several of those dates land this month.
    • “[The article identifies] six hospital-use drugs with a shortage-related deadline in July, according to the FDA’s drug shortage database and its list of extended use dates.”

From the U.S. healthcare business front,

  • Beckers Hospital Review discusses “Kaiser Permanente’s partnership strategy and what comes next” and identifies “15 maternity service closures in 2026.”
  • Fierce Healthcare reports,
    • “For a month now, weekly prescriptions for Eli Lilly’s Foundayo have been hovering at around 20,000. In other words, three months into its market debut, the non-peptide GLP-1 receptor agonist was still at the same script level that Novo Nordisk’s Wegovy pill had achieved in two to three weeks post-launch.
    • “For the week ended on June 26, Foundayo’s total scripts dipped about 4% sequentially to 19,830, according to IQVIA data cited by Jefferies. During the same period, scripts were also down about 2% for oral Wegovy, reaching about 149,000.
    • “In a July 4 report, Jefferies analysts modeled about $71 million in U.S. sales during Foundayo’s debut quarter from April to June, versus the team’s previous estimate of $85 million in a June 26 report. Wall Street’s consensus currently has the number at $130 million. To reach its estimate, Jefferies used an illustrative calculation based on the IQVIA data, with certain assumptions regarding pricing, dosing and stocking.
    • “While Lilly still lags Novo on the oral GLP-1 battlefield, the Indianapolis pharma has maintained a majority 59.5% share of the overall obesity market, according to IQVIA’s prescription data.” 
  • The Wall Street Journal informs us,
    • Vertex Pharmaceuticals VRTX has agreed to purchase Crinetics Pharmaceuticals CRNX for $10 billion, adding a biopharmaceutical company that specializes in treatments for endocrine diseases to its portfolio that mainly includes cystic fibrosis therapies.
    • Vertex, a Boston-based biotechnology company, said it would acquire Crinetics for $85 a share in cash. The company pegged the value at $8.8 billion when accounting for net estimated cash acquired.
  • and
    • Novartis NOVN said it agreed to pay up to $1.5 billion for Myricx Bio, in a bid to bolster its portfolio amid industry competition for oncology drugs.
    • “The Swiss pharmaceutical company said it would purchase the privately held U.K.-based biotechnology firm, which is developing a new class of antibody-drug conjugates. Myricx Bio’s approach delivers differentiated cancer-killing mechanisms directly to tumor cells, Novartis said.
    • “Novartis will pay $1.1 billion upfront, with up to $400 million in potential additional payments. The deal, expected to close in the second half of 2026, is subject to regulatory approvals. Myricx Bio has a pipeline of antibody-drug conjugates that show pre-clinical efficacy and tolerability across tumor-associated antigens and cancer cell types, it said.”
  • BioPharma Dive adds,
    • “Drug developers making new medicines to treat autoimmune conditions and cancer made up more than 40% of the venture funding rounds in the first half of 2026, BioPharma Dive data show.
    • “Of the more than $9 billion that poured into venture-backed biotechnology companies from 26 highly active investors tracked by BioPharma Dive, a little more than $3.9 billion went toward immune and cancer drugmakers. About $2.1 billion of that figure alone was dedicated to that former bucket, in which many startups are working on experimental therapies for conditions such as lupus, atopic dermatitis and inflammatory bowel disease. A handful are developing drugs in these two fields simultaneously (and have been included in the funding totals for each).
    • “While exits might be concentrated in other research areas like obesity and cardiometabolic disorders, venture funding is likely to continue pouring into cancer and immunology because of a lack of “a time-sensitive element,” said Ben Zercher, a senior analyst at PitchBook.”

Wednesday report

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

Simplicity is a virtue.

HAPPY NATIONAL POSTAL WORKERS DAY!

From Washington, DC,

Plenty of news from the U.S. Office of Personnel Management today.

  • Per an OPM news release,
    • “Today, the US Office of Personnel Management (OPM) announced the “Last Day of Paper,” officially ending paper retirement processing for more than 95 percent of federal retirement applications and completing the agency’s transition to a fully digital retirement process.
    • “For decades, federal retirement applications relied on a paper-based process that required physical documents to move between agencies, payroll providers, and OPM’s Retirement Operations Center in Boyers, Pennsylvania. As of yesterday, nearly all retirement applications will be submitted and processed electronically through OPM’s Online Retirement Application (ORA), eliminating paper from the process and significantly reducing processing times.
    • “The milestone follows rapid adoption of ORA, which has processed more than 155,000 retirement applications over the past year after serving only a few hundred users during its initial rollout.” * * *
      • “As part of today’s milestone, OPM is also launching new capabilities designed to accelerate retirement processing, including:
      • “A new pre-retirement application that allows employees and agency HR offices to complete much of the retirement process before an employee’s separation date.
      • “Earlier processing of retirement applications while final payroll information is still being finalized, reducing unnecessary delays.
      • “A commitment to issue a retiree’s first pension payment within seven days of retirement for applicants who submit a complete retirement package by their separation date.”
  • FEHBlog observation – While OPM deserves credit for this accomplishment, the agency has not announced implementing the HIPAA standard transaction 820 which is an electronic enrollment roster that would allow carriers to reconcile premiums to individual enrollments. The HIPAA 820 has been around since 2012. Carrier systems must accept the HIPAA 820. What is the sense in collecting family member eligibility documents when no one currently knows whether the enrollee is paying the proper premium?
  • Govexec adds,
    • “The federal government’s 401(k)-style retirement savings program posted mixed results in June, ending two straight months of consistent growth.
    • “The Thrift Savings Plan’s S Fund, which is made up of small- and mid-size businesses, saw the best performance, gaining 4.34% last month. Since January, the S Fund has grown 18.41%.
    • “The fixed income (F) fund increased 0.25% last month, bringing its 2026 performance to 0.74%. And the G Fund, which is made up of government securities, increased by its statutorily mandated rate of 0.37%. So far this year, the G Fund has swelled 2.18%.
    • “But the I Fund was virtually flat in June, losing 0.03%. That brings the I Fund’s 2026 performance to 16.53%. And the C Fund’s common stocks fell 0.95%, bringing its gains since January down to 10.20%.”
    • The performance of other funds can be found in the article.
  • Another OPM news release tells us,
    • “The US Office of Personnel Management (OPM) today proposed sweeping reforms to modernize how agencies address poor performance, streamline disciplinary and removal procedures, and strengthen accountability across the federal workforce.
    • The proposed rule would require agencies to better equip supervisors with training on employee accountability while making it easier to address employee performance issues. Among other reforms, the proposal establishes a default 30-day Performance Improvement Plan (PIP), eliminates pre-PIPs that unnecessarily delay action, standardizes employee response periods for adverse actions, and modernizes Merit Systems Protection Board review of adverse action appeals by replacing the current checklist-based approach (called “the Douglas factors”) with a totality-of-the-circumstances standard.
    • This proposal is part of the Trump Administration’s broader effort to build a high-performing federal workforce that rewards excellence, recognizes strong performance, and holds employees accountable when performance falls short.” * * *
    • “The proposed rule will be published in the Federal Register and will be open for public comment. Read Director Kupor’s blog post on this here.”
  • OPM Director Scott Kupor added a second post to this Secrets of OPM blog today. The second post is titled “Measure what matters.”
    • “Last year, we postponed the Federal Employee Viewpoint Survey (FEVS) and critics were quick to claim that we at OPM did not believe in employee engagement surveys. That couldn’t be farther from the truth. * * *
    • So, today we announced that OPM will no longer centrally administer FEVS. As a centrally-administered system, it’s costly, doesn’t serve as a valuable management tool and fails to enable actionable results. That serves nobody well.
    • Instead, we have provided detailed guidance to agencies on how best to design surveys that meet their specific needs. That guidance includes a common set of core questions that every agency will ask—ensuring we preserve the ability to track government-wide trends and maintain a coherent thread of data across the federal workforce. The goal isn’t fragmentation; it’s better ownership. Agencies will have the flexibility to go deeper where their missions demand it, while OPM retains the visibility to understand the broader landscape and identify where systemic challenges require government-wide attention.”
  • Federal News Network reports,
    • “President Donald Trump said Monday [June 29] he will nominate Keith Sonderling to be the secretary of labor, elevating him from the agency’s acting director two months after Lori Chavez-DeRemer resigned amid abuse-of-power allegations.
    • “Sonderling, a lawyer who has held a variety of acting positions and leadership roles across Trump’s government, was previously the deputy labor secretary and a Republican member of the Equal Employment Opportunity Commission.
    • “Throughout his career, Keith has proven his dedication to delivering strong results for the Hardworking People of our Country, and I know he will do an incredible job in his new role,” Trump wrote in a Truth Social postannouncing Sonderling’s nomination.
    • Sonderling’s nomination is subject to Senate confirmation.
  • Fierce Healthcare relates,
    • “The Trump administration has officially launched its new “bridge” model that brings GLP-1 coverage for weight loss to Medicare beneficiaries.
    • “Eligible people enrolled in Medicare Part D can secure certain GLP-1 medications for weight loss or management at $50 each month. The program will remain in place through the end of 2027, the Centers for Medicare & Medicaid Services said in an announcement.
    • ‘Under the GLP-1 bridge, the feds will cover the cost of expanded coverage. Alongside this model, the agency also proposed a second approach—called Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth, or BALANCE—in which it would negotiate lower GLP-1 prices in exchange for standardized coverage options.
    • “Plans balked at the model, and CMS indefinitely delayed from a planned January 2027 start date. A similar model was implemented in Medicaid in May 2026.
    • “In a CMS announcement commemorating the model’s launch, Administrator Mehmet Oz, M.D., urged beneficiaries to reach out to their doctors to see if they’re eligible.
    • “For too long, many Americans have been unable to access these treatments because of cost,” Oz said.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is proposing new safeguards to ensure taxpayers aren’t on the hook for noncompliant Medicare providers and suppliers, continuing its campaign to crush fraud, waste, and abuse throughout its programs and hold bad actors accountable. The Calendar Year (CY) 2027 Home Health Prospective Payment System (PPS) proposed rule would strengthen CMS’ ability to recover improper payments and remove non-compliant providers and suppliers from Medicare, actions estimated to save approximately $82 million in annual savings, while also expanding access for patients receiving care at home and improving the timeliness of publicly reported home health agency quality information.”
    • * * * “The proposed rule also would update Medicare home health payment rates for CY 2027. At the same time CMS is strengthening oversight and crushing fraud, waste, and abuse, the agency is proposing targeted payment updates that support access to care for beneficiaries who rely on home health services. CMS is also proposing to continue to fulfill its statutory obligation to transition the Home Health PPS to the Patient-Driven Groupings Model in a budget-neutral manner. CMS estimates total Medicare payments to home health agencies would increase by approximately 2.4%, or $420 million, compared to CY 2026.” * * *
    • “To view a fact sheet on the proposed rule, visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2027-home-health-prospective-payment-system-proposed-rule-fact-sheet-cms-1844-p. 
    • “The proposed rule can be viewed on the Federal Register at: https://www.federalregister.gov/d/2026-13602.” 
       
  • Per a GAO news release,
    • “A leading cause of death in the U.S., suicide resulted in more than 49,000 deaths in 2023. That’s up by 31% from 2003.
    • “To help those at risk, the federal government set up the 988 Suicide & Crisis Lifeline. It offers support via call, text, and chat.
    • “Since the Lifeline’s inception in July 2022 through September 2025, we found:
      • “Call, text, and chat contact volume increased
      • “Call answer rates increased, while text and chat answer rates varied
      • “Average time to answer calls, texts, and chats varied
    • “We also found that the federal government set goals for the Lifeline. It collected data related to those goals and used it to assess its performance.”
  • HR Dive points out,
    • “The U.S. Equal Employment Opportunity Commission rescinded its affirmative action guidelines Tuesday, eliminating an interpretation that had persisted for 40 years.
    • “According to a June 30 statement, the guide and a related compliance manual “ran afoul” of Title VII of the Civil Rights Act of 1964 and more recent U.S Supreme Court rulings in the eyes of the commissioner. Almost three years ago to the day, the high court issued its decision in Students for Fair Admissions, Inc. v. Harvard, holding that race-conscious admissions practices at two universities were unconstitutional.” * * *
    • “The takeaway from the new plan should not be to “abandon lawful EEO efforts, but to ensure policies do not use protected characteristics as selection criteria,” management-side attorney Randi Hyatt, a partner at Whiteford, Taylor & Preston, said in an analysis.”

No Surprises Act News

  • Fierce Healthcare reports,
    • “Healthcare technology company Zelis rolled out an AI-native solution to help health plans manage Independent Dispute Resolution complexity under the No Surprises Act.
    • “Independent Dispute Resolution (IDR) is the process for adjudicating out-of-network claims created by 2020’s No Surprises Act (NSA).
    • “Zelis’ solution uses AI to automate payers’ workflows, from claim repricing, open negotiation, dispute prevention, case management and IDR resolution. The company unveiled the new solution as dispute volume, compliance requirements and process deadlines pressure payer operations, executives said.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent β thalassemia (TDT). This is the first gene therapy approved for patients aged 2 years and older with SCD.  
    • Casgevy has been previously approved for the treatment of patients aged 12 years and older with SCD with recurrent VOCs or TDT.  
    • “With today’s decision, pediatric patients as young as 2 years of age can now access a critical additional treatment option to treat these debilitating, life-threatening diseases,” said Karim Mikhail, B. Pharm., M.S., Acting Director of the Center for Biologics Evaluation and Research (CBER). “The FDA is committed to prioritizing and speeding up the review of products that address critical U.S health priorities through expedited review programs, including the FDA Commissioner’s National Priority Voucher (CNPV) Pilot Program. These initiatives are designed to advance therapies for diseases with significant unmet medical needs, enabling faster access to innovative treatments while upholding the FDA’s rigorous gold-standard requirements for safety and effectiveness.”  
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today commended the Drug Enforcement Administration’s (DEA) issuance of two Notices of Intent to begin the temporary scheduling process for certain kratom-related substances.
    • ‘One Notice of Intent addresses temporary placement of 7-OH above a specified threshold in Schedule I, while the second would temporarily place three synthetic 7-OH derivatives into Schedule I of the Controlled Substances Act (CSA):
      • “Mitragynine pseudoindoxyl (MP)
      • “Dihydro-7-hydroxymitragynine (MGM-15)
      • “The 9-fluoro derivative of 7-hydroxymitragynine (MGM-16)
    • “Concurrent with DEA’s Notice of Intent addressing 7-OH, the Office of the Assistant Secretary for Health (OASH) issued a Request for Information (RFI) on seeking public comment on the proposed 7-OH threshold level in the NOI. The request is limited to obtaining comments on whether: 1) there is additional scientific data to support the proposed or an alternative threshold level – specifically, what concentration or quantity of 7-OH in a product constitutes an imminent hazard to public safety; and 2) data exist supporting alternative measurement expressions for purposes of specifying the threshold level that is necessary to avoid an imminent harm to public safety.
    • “After the 30-day comment period for the RFI, OASH will provide comments submitted to the RFI public docket to the Attorney General for consideration. Once comments have been considered and at least 30 days have passed since the publication of the NOI, the Attorney General may then issue a temporary scheduling order placing 7-OH above a certain threshold in Schedule I. The CSA provides the Attorney General with the authority to issue a temporary scheduling order placing a substance in Schedule I of the CSA for two years, if such action is necessary to avoid an imminent hazard to public safety.”
  • Cardiovascular Business relates,
    • “Amgen is recalling nearly 935,000 bottles of ivabradine, a heart failure drug the company sells under the brand name Corlanor, due to the presence of a foreign substance. 
    • “The recall includes specifics lots of 5-mg and 7.5-mg Corlanor tablets manufactured in Italy and then distributed by Amgen throughout the United States. The drugs are packaged in 14- and 60-tablet bottles. Expiration dates range from July 2026 to December 2028.
    • “The U.S. Food and Drug Administration (FDA) has categorized this as a Class II recall, which means taking the drugs in question could cause “temporary or medically reversible adverse health consequences.”
    • “Amgen first received FDA approval for ivabradine in April 2015. The agency’s decision was largely based on data from the SHIFT trial, which included more than 6,500 patients randomized patients treated with ivabradine or a placebo. In 2021, researchers found that ivabradine could be used to treat symptoms associated with postural orthostatic tachycardia syndrome in COVID-19 patients.”
  • MedTech Dive adds,
    • “The Food and Drug Administration has reported 252 injuries were associated with Hologic’s BioZorb radiographic markers implanted in the breast and other soft tissue sites during medical procedures. No deaths were reported.
    • “The update comes almost two years after Hologic told customers to stop using the devices due to reports of adverse events such as pain, infection and device migration. At the time, Hologic said it had received 188 complaints associated with adverse events.
    • “In its latest communication, the FDA repeated Hologic’s instructions advising healthcare providers not to use the BioZorb markers. Patients should be monitored for signs of adverse events, but Hologic said there is no need to have an implanted marker removed from the body.”
  • Beckers Hospital Review tells us,
    • “Cisplatin, carboplatin, oxaliplatin and ifosfamide remain in active shortage, and manufacturers’ latest estimates show full resupply of some formulations will not arrive until October, according to updates posted by the American Society of Health-System Pharmacists. 
    • “The four chemotherapy drugs form the backbone of treatment for breast, lung, ovarian, testicular, bladder, and head and neck cancers. Becker’s previously reported that hospitals and cancer clinics working with group purchasing organization Premier received only 38% of their ifosfamide orders and about two-thirds of their cisplatin orders in recent weeks, prompting some healthcare organizations to space out doses and prioritize patients most likely to benefit from treatment.”
  • BioPharma Dive identifies “5 FDA decisions to watch in the third quarter of 2026.”
    • “A group of coming decisions could provide important insights into how flexible the agency is willing to be under new leadership.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “West Nile virus activity is starting earlier than it has in years, with the CDC warning it is now seeing the highest number of human cases of the nasty mosquito-borne disease since 2004.
    • ‘At least 48 cases had been reported as of Tuesday, and 38 have involved serious illness affecting the brain or nervous system. 
    • “For comparison, by the end of June, the Centers for Disease Control and Prevention usually sees only about 10 human cases. The earlier start could be problematic, as it extends the amount of time people could be exposed to the disease before the season dies down in colder months.” * * *
    • “Arizona has reported the highest number of cases in the country at 32. Maricopa County, the state’s most populous county, has reported 29 cases, including four deaths, already more than half of the case total it reported in all of 2025.”
  • Drug Topics relates
    • “Surveillance through June 2026 shows widespread, outbreak-driven measles transmission, with 93% of cases in unvaccinated/unknown-status individuals and 6% requiring hospitalization. 
    • “Erosion of kindergarten MMR coverage from 95.2% to 92.5% leaves hundreds of thousands susceptible, while subregional coverage can fall near 50%, enabling explosive outbreaks. 
    • “Utah’s large outbreak prompted enhanced monitoring, including wastewater-based detection, and recommendations for earlier MMR dosing (from 6 months) to mitigate infant risk. 
    • “Persistent misinformation and vaccine hesitancy necessitate motivational interviewing techniques (OARS, readiness rulers) and proactive pharmacist-led community engagement to rebuild trust and uptake.”
  • Managed Health Executive points out,
    • “Physical inactivity and racial and ethnic minority status emerged as the two strongest predictors of diabetes prevalence across U.S. counties in a new machine-learning analysis published in Diabetes/Metabolism Research and Reviews.
    • “The cross-sectional study, led by Nicolaas P. Pronk, Ph.D., of the HealthPartners Institute, set out to capture what the authors call the “multilevel ecology” behind diabetes, defined as the mix of broad structural forces and individual-level behaviors that impact diabetes development.”
  • Beckers Clinical Leadership lets us know about “Lung cancer screening, mortality and incidence — by state.”
    • “At 11%, California had the lowest up-to-date lung cancer screening rate in 2024, while Connecticut, Massachusetts and Pennsylvania had the highest rate at 28%, according to American Cancer Society data. 
    • “The national median rate for up-to-date lung cancer screening in 2024 was 18%.
    • “Lung cancer mortality and incidence remain highest in Kentucky and West Virginia, despite having above-average lung cancer screening rates.” 
  • Health Day tells us,
    • “Stepped alcohol treatment (SAT) offered via telehealth helps people with chronic liver disease (CLD) reduce alcohol consumption, according to a study published online June 24 in Hepatology.
    • “Derek D. Satre, Ph.D., from the University of California, San Francisco (UCSF), and colleagues evaluated the efficacy of telehealth SAT, which consisted of three motivational interviewing sessions followed by addiction medicine referral if no drinking reduction at month 3. One hundred fifty-seven adults with CLD and unhealthy alcohol use (>7 drinks/week or ≥4/day for women; >14/week or ≥5/day for men; or heavy episodic drinking) were randomly assigned to SAT (81 participants) or usual care (76 participants). 
    • “The researchers found that SAT had no difference in percentage of alcohol use below moderate level (primary outcome) versus usual care. However, SAT had greater reduction in drinks/week from baseline to month 3 and month 6 (estimates, −0.66 and −0.67, respectively) (secondary outcome). Compared to usual care, the six-month effect of SAT on alcohol use reduction remained significant when controlling for covariates. The 30-day abstinence rates were 29 percent for SAT and 18 percent for usual care at month 6. There was a positive association between baseline motivation to reduce alcohol use and treatment response.”
  • The latest NIH Research Matter covers the following topics:
    • “Alzheimer’s proteins in blood linked to midlife cognition 
      • “A study found that people in midlife with more Alzheimer’s-related proteins in their blood had worse cognitive function.
      • “The results suggest blood tests could one day help identify people who may benefit from early efforts to delay Alzheimer’s symptoms.”
    • “Genetic testing may benefit more patients with melanoma 
      • “Researchers found people diagnosed with melanoma at a young age or with multiple melanomas were more likely to carry a genetic mutation.
      • “The findings suggest that certain patients with melanoma could benefit from genetic testing to identify mutations and potential risk for other types of cancer.”
    • “Senescent cells mapped in human body over the lifespan
      • “Scientists located and classified senescent cells, a hallmark of aging, to begin building an atlas of these non-dividing cells in the human body.
      • “The atlas could help track how senescent cells drive age-related conditions and may inform treatment strategies for age-related diseases.”
  • The University of Minnesota’s CIDRAP notes,
    • “Vaccine myths are not new. They have circulated for decades, surviving retracted studies and countless public health campaigns. Now, a new poll suggests that, while relatively few Americans fully believe those falsehoods, many remain uncertain about them—a finding that suggests opportunities to counter vaccine misinformation.” * * *
    • “The poll found a strong association between trust in healthcare providers and vaccine attitudes, with adults who have a provider they trust being less likely to believe vaccine myths.
    • “Just under half of adults (46%) who do not have a trusted healthcare provider to answer questions about their health said it was “probably” or “definitely true” that more people have died from COVID vaccines than from COVID itself. That’s almost twice as many as those who reported having a trusted provider (24%). 
    • “Researchers noted that the relationship remained significant even after accounting for factors such as age, race and ethnicity, education, political affiliation, and insurance status.”
  • Per BioPharma Dive,
    • “Shares of Paris-based biotechnology company Abivax surged nearly 40% Tuesday following the release of supplementary Phase 3 data on its inflammatory bowel disease drug that cleared away investors’ concerns about increased cancer risk.
    • “Abivax said cancer rates seen across enrollees in its Phase 2 and Phase 3 trials were no higher than the “background” one seen in people with ulcerative colitis, which is higher than the general population in certain types of malignancies.
    • “The update from the second part of that Phase 3 trial — which enrolled people who didn’t respond to the drug or relapsed during the trial — added safety data that “appropriately addresses the key overhang facing the stock,” wrote Jefferies analyst Faisal Khurshid in a client note. Abivax followed the share price increase with an $800 million sale of its U.S. listed shares.”

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

  • Modern Healthcare reports,
    • “Brian Evanko, Cigna Group’s new chief executive officer, said he aims to put patients at the center of the company’s strategy. He’ll have to convince people struggling with rising healthcare costs that he’s serious — and persuade Wall Street that this strategy can be profitable. 
    • “That’s been a difficult balancing act for Cigna. Last year the company announced that it would phase out rebate payments from drug companies in many of its prescription plans, pulling back from a “middleman” practice the Trump administration has criticized.
    • “Cigna said this would lower patient costs and only temporarily shrink profits. But investors punished Cigna with its worst selloff in 17 years. Its shares still haven’t recovered.”
    • “It’s a tension Evanko will have to navigate beginning Wednesday when he becomes the public face of Cigna, a giant in medical insurance, prescription drug benefits and specialized pharmacy services. Insurers are under fire in Washington for high costs. Employer clients are balking at premium hikes. Patients are frustrated with spending-control tactics like prior approvals. And investors are wary that addressing those concerns could erode profits.
    • “Evanko said he’s focused on making Cigna more responsive to the 185 million people who use its healthcare services, the bulk of whom have prescription drug coverage managed by the business.
    • “For me, coming into the role, importantly, we’re going to put the customer at the center of everything we do, so being patient-first,” Evanko, 50, said in a recent interview at Bloomberg’s New York headquarters. “We see that as actually a strategic choice.”
  • Beckers Payer Issues relates,
    • “Hospitals and insurers have been fighting an AI billing war for the better part of two years, with providers deploying the technology to optimize and defend their coding, and payers using it to audit and push back.
    • “AI is placing pressure on cost through RCM tools, and we have seen those patterns in terms of service intensity, and cost per encounter going up,” UnitedHealthcare CEO Tim Noel said at a June media event attended by Becker’s. “It clearly has occurred, and that is a source and driver of trend. I don’t think that that’s going to be persistent. That’s a moment that we’re in that will get to saturation.”
    • “Revenue cycle executives and physicians have described the ongoing dynamic as an “AI arms race,” that has been adding administrative cost and friction on both sides. This month, PwC projected that employers’ medical cost trend will reach its highest level in 17 years in 2027, pointing to provider adoption of AI documentation and coding tools as one of five primary inflators. Nearly 70% of surveyed health plans ranked it among their top three concerns, and roughly 20% named it the single largest driver.
    • “Mr. Noel said UnitedHealthcare is already working to move beyond paid-claims data to understand “more upstream where these hot spots are.” 
    • “The global trends are the global trends, and there are some opportunities to address those in the moment, and we are,” he added. “But we also have to look for new sources of affordability moving forward.”
  • and
    • “Sustainability has become less about cutting costs and more about redesigning how healthcare delivers value. Becker’s asked several health plan leaders how they’re thinking about long-term sustainability, and the responses point to a shared shift away from volume-driven models toward outcomes, accountability, and member-centered design. From shifting social health programs toward measurable, evidence-based interventions to redesigning the consumer experience around choice and transparency, leaders are converging on the idea that sustainability isn’t a single initiative — it’s a durable operating model built for the long haul.
    • “The answers below reflect a range of strategies, from strengthening payer-provider partnerships and embedding AI into clinical decision-making to balancing financial discipline with health equity and community trust. Common threads emerge around reducing low-value care, building data infrastructure that supports proactive rather than reactive management, and designing systems flexible enough to adapt as member needs evolve. [In the article], healthcare leaders share how they’re positioning their organizations for what’s next.
  • Vizient discusses “From scale to orchestration: The new requirements for payer success.”
    • “For executive and board consideration:
      • “Evaluate strategic pathways, including independence, partnership, affiliation, or acquisition.
      • “Assess strengths and gaps across products, member diversification, scale, and market positioning
      • “Identify partners that align across strategy, governance, economics, and long-term objectives.
      • “Execute transactions and integrations with rigor and discipline.”
  • MedCity News considers,
    • “Healthcare’s Most Avoided Question: “How Much Exactly Do You Need, and What Will America Get in Return?”
      • “Before policymakers, employers, insurers, or taxpayers commit ever-larger sums to the system, an uncomfortable question deserves attention: How much additional capacity does healthcare actually need and what measurable outcomes should society expect in return?”
  • Modern Healthcare tells us,
    • “Allegheny Health Network closed its acquisition of Heritage Valley Health despite pushback from the Pennsylvania attorney general. 
    • “The deal adds Heritage’s two hospitals, dozens of clinics and 500 employed and affiliated physicians to the 16-hospital provider division of Highmark Health.
    • “A final order Friday from a federal court paved the way for the transaction’s close, with conditions. Last Wednesday, Pennsylvania Attorney General Dave Sunday (R) sued to block the transaction over potential anticompetitive effects. He claimed the acquisition could allegedly increase hospital and radiation oncology prices in Beaver County and Allegheny County.
    • “The order from U.S. District Court for the Western District of Pennsylvania Judge Maureen Kelly requires Allegheny Health to provide current services at the rebranded AHN Beaver Hospital – Heritage Valley and AHN Sewickley Hospital – Heritage Valley for at least five years and maintain an existing joint venture between Heritage Valley and UPMC Cancer Centers.
    • “In addition, Allegheny cannot terminate automatic renewal clauses in its insurer contracts for at least a year and it must pay Sunday $75,000 in legal fees, among other provisions.”
  • The Wall Street Journal informs us,
    • “Ipsen IPN said it agreed to buy Swiss biotechnology company Memo Therapeutics in a deal that could exceed 700 million euros ($799.6 million) and that seeks to expand the French drugmaker’s rare-disease portfolio.
    • “The move marks Ipsen’s second acquisition this week after its agreement to take over Kartos Therapeutics, a company developing a drug to treat a rare blood cancer, for up to $1.75 billion.
    • “Ipsen said it would pay 200 million euros initially and make deferred payments subject to certain development, regulatory approval and sales-based targets that could take the total price above 700 million euros.
    • “The deal focuses on Memo’s experimental drug potravitug for the treatment of nephropathy associated with BK polyomavirus, a complication in kidney transplant recipients, Ipsen said. The drug—which was granted fast-track designation from the U.S. Food and Drug Administration in 2023—is due to move to a mid- and late-stage clinical trial later this year, the company added.”
  • Fierce Healthcare points out,
    • “Patients are taking charge of their healthcare with artificial intelligence and other solutions, with 58% of U.S. patients researching symptoms before deciding whether to book an appointment, according to a new report from ZS Impact Institute. 
    • “The recent report drew insights from nearly 10,000 healthcare consumers and providers across the U.S., Germany and China. Researchers note the shift is consistent across healthcare systems, which they say points to a “broader breakdown in how patients seek and experience care globally.”
    • “Thirty-seven percent of U.S. respondents report using search engines for health information—94% of which find it helpful—and 18% report using AI. Eighty-nine percent of those using AI to find information report it being helpful.”
  • and
    • “Evernorth has unveiled a new specialty pharmacy program that leans on AI to support a better experience for patients with complex conditions.
    • “Called Pharmacy Forward, the program aims to use technology to drive more coordinated, connected care and to offer personalized supports in real time. Evernorth plans to launch the program first for Accredo Specialty Pharmacy customers, investing $100 million through 2028 in the project.
    • “The goal, according to an announcement from the company, is to allow care teams to spend more time on clinical and patient care, while also accelerating prescription processing and service responsiveness.
    • “Patients navigating complex health conditions need comprehensive, expert support, often during some of the most difficult moments in their lives,” said Matt Perlberg, president of the Evernorth Health Services pharmacy and care delivery businesses, including Accredo, and executive vice president of Customer Innovation for The Cigna Group, in the announcement.”
  • Beckers Health IT notes,
    • “Anthropic is launching an internal drug discovery program with a focus on neglected diseases that traditional pharmaceutical companies would not consider commercially attractive, CNBC reported June 30.
    • “At a June 30 event in San Francisco, Eric Kauderer-Abrams, Anthropic’s life sciences head, said the effort is designed to give the company firsthand experience in drug development as it builds AI tools for biopharma customers. Anthropic leaders framed the drug discovery program as a way to build credibility with the biopharma companies it hopes to win as Claude Science customers.
    • “Jonah Cool, Anthropic’s head of life sciences partnerships, said the focus on neglected diseases will run alongside the company’s broader push to create and sell AI tools to life sciences companies.”
  • Genetic Engineering and Biotechnology News adds,
    • “Anthropic has released Claude Science, an AI workbench for scientists that consolidates fragmented research tools, including over 60 scientific databases and connectors pre-configured for genomics, proteomics, structural biology, and more, into a single reasoning layer. The platform joins an increasingly crowded ecosystem of tech platforms specialized for biology and aims to accelerate scientific discovery by making domain expertise more accessible.
    • “Anthropic’s life science partners are delivering applications. Basecamp Research is targeting global public health, where drug-resistant infections play a role in nearly five million deaths per year. The London-based team has announced that its antibiotic design and vaccine target prediction EDEN models will now be available through Claude Science.
    • “A metagenomic foundation model, EDEN demonstrated a 97% success rate when designing functional peptides with high potency against World Health Organization (WHO) critical-priority and multidrug-resistant pathogens. The work was done in collaboration with César de la Fuente, PhD, presidential associate professor at the University of Pennsylvania.”

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.”

Monday report

David Ermer–Agentic & Generative AI, CDC, Congress, FDA, Federal employment benefits, Government Contracting, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Roll Call reports,
    • “The solstice this weekend marked the start of astronomical summer — and in Washington, D.C., that means the legislative clock is ticking.
    • “Lawmakers are eager to head home and campaign on a housing bill that’s nearing passage, but progress on several other issues has stalled, and it’s unclear whether a visit from President Donald Trump will break the logjam or cause further obstruction.”
  • Congress.gov finally has updated this week’s Committee hearings list. No hearings were held today. Of note,
    • Senate Committee on Homeland Security and Governmental Affairs
    • Wednesday, June 24, 2026
    • 9:30 AM (EDT) – Senate | 342 Dirksen Senate Office Building, Washington, D.C.
    • Open Hearing: Hearings to examine reforming the U.S. Postal Service’s business model.
    • Meeting Details
  • Federal News Network tells us,
    • “The Federal Regulatory Council is giving the federal community one more chance to speak up before the first set of major revisions to acquisition regulations becomes final.
    • “In Tuesday’s Federal Register, the FAR Council will release the first tranche of proposed rules for 17 sections of the FAR.
    • “Industry and government have largely seen these changes in the deviations, but there are additional differences or changes from what we have in deviations,” said an OMB official, who requested anonymity in order to discuss the proposed rules. “The general premise for each of the rules should already be familiar to most people. This is now to tell us where we missed something or how to refine a particular area.”
  • Kevin Moss, writing in Federal News Network, points out,
    • “Benjamin Franklin famously wrote, “In this world nothing can be said to be certain, except death and taxes.” If Flexible Spending Accounts had existed in his time, he might have added one more certainty: If you use an FSA, you’ll save money on your healthcare expenses.
    • “Yet despite rising healthcare costs and tighter budgets, most federal employees are leaving this guaranteed savings opportunity on the table. In fact, only one in five participate in the FSA program, meaning most employees are paying more than they need to.
    • “The good news? FSAs aren’t complicated, and you don’t have to be a benefits expert to take advantage of them.
    • “In this article, we’ll break down how they work, share a simple strategy to help you use one successfully (even if it’s your first time), and show why this is one of the easiest ways federal employees can immediately reduce their out-of-pocket healthcare costs.”
  • The FEHBlog heartily agrees with Mr. Moss.
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a coordinated department-wide effort [PDF, 2.10 MB]* to strengthen America’s leadership in clinical research, accelerate the development of lifesaving treatments, and ensure that patients have access to the most innovative therapies in the world.
    • “For decades, randomized clinical trials have served as the gold standard for evaluating the safety and effectiveness of new medical treatments. Yet in recent years, a growing share of early-stage clinical research has moved overseas, threatening America’s position as the global leader in biomedical innovation. Under President Trump’s leadership, HHS is taking decisive action to reverse that trend and make the United States the preferred destination for clinical research and medical discovery.”
  • Beckers Payer Issues relates,
    • “Earlier in June, the HHS Office of Inspector General published two reports shedding light on post-acute care denials and overturned appeals from Medicare Advantage organizations. AHIP is pushing back.
    • “The reports ignore serious, well-documented concerns about wide variations in the cost and quality of post-acute care and skilled nursing facilities. More than 35 million Americans actively choose MA because it provides them with better, more affordable care — including helping seniors transition to high-quality, clinically appropriate care settings to support their rehab and recovery,” an AHIP spokesperson said in a June 11 statement.
    • “AHIP cited previous OIG research from 2018 that raised concerns about spending and quality with post-acute care. Based on a sample, OIG estimated Medicare paid inpatient rehabilitation facilities across the country $5.7 billion for unnecessary or unreasonable beneficiary care. The news release also featured Stanford (Calif.) University research from 2022 on risks of skilled nursing facility overuse based on Medicare’s reimbursement approach.
    • “AHIP also pointed to a lack of context in the OIG reports. Administrative issues — including out-of-network providers, services excluded from coverage and missing documentation — could all contribute to denials, not just denials that did not meet medical necessity standards. AHIP said reports also excluded common rationales for overturned denials, such as providers’ offices adding information that was initially missing from a claim.
    • “When combined with timely clinical information from our provider partners, prior authorization supports safe, effective and affordable care,” a CVS spokesperson previously told Becker’s. “We review requests promptly, offer a clear appeals process and are leading the way for continuous patient-centered improvements.”
    • “AHIP commissioned insights from analytics firm Inovalon, finding that, compared to fee for service, MA patients had 30% fewer inpatient days and 71% fewer preventable hospitalizations.”

From the Food and Drug Administration front,

  • The American Hospital Association reports,
    • “The Food and Drug Administration June 22 announced multiple actions to help accelerate early- and late-stage drug development. The actions are part of a larger Department of Health and Human Services initiative announced June 22 on clinical research efforts, called Operation TrailBlazer. The FDA’s efforts include a request for information on a new drug pilot program that would shorten the period from drug identification to first-in-human studies and protect clinical trial participants. The program would create a network of qualified research institutions, including academic medical centers, healthcare networks, contract research organizations, regulatory advisors and other research organizations, to partner with sponsors and develop and review protocols for first-in-human clinical trials intended for new drug submissions to the FDA.” 
  • The Wall Street Journal relates,
    • “The Food and Drug Administration has agreed to reverse its rejection of Regenxbio’s RGNX experimental gene therapy for a rare and fatal brain disease, the company said, the latest about-face by the agency under new leadership.
    • “The FDA didn’t respond to requests for comment.” * * *
    • “Regenxbio’s Navsunli therapy targets Hunter syndrome, a rare genetic disease that causes irreversible brain damage and cell death, usually leading to death in a patient’s midteens. 
    • “The disease affects about 2,000 people worldwide—nearly all boys—and about 50 people are diagnosed a year in the U.S.
    • “Navsunli promises to replace a defective gene, allowing boys who take the drug to start producing a protein that prevents the buildup of harmful substances in the brain and tissues.”
  • MedTech Dive tells us,
    • “Johnson & Johnson’s Abiomed alerted physicians to a risk associated with eight instances of major bleeding in patients treated with its Impella heart pumps.
    • “The Food and Drug Administration, which posted an early alert notice about the issue Thursday, said Abiomed and its manufacturing partner, Oscor, wrote to users about the catheter introducer issue this month.
    • “Hospitals can continue to use existing inventory. However, physicians should consider a device exchange or using the repositioning sheath to minimize blood loss if they see a potential leak.”
  • and
    • “Zoll received a warning letter from the Food and Drug Administration citing quality concerns and problems with how the firm handles complaints. 
    • “The warning letter focused on MRI compatibility problems with some of Zoll’s portable ventilators. It also cited concerns with automated external defibrillators and electrodes used with the company’s defibrillators.
    • “Zoll, a subsidiary of Asahi Kasei that makes ventilators, defibrillators and other medical devices, received the warning letter on April 30, and the FDA posted the letter on Tuesday. The warning followed an inspection of Zoll’s facility in Chelmsford, Massachusetts, where the company is headquartered, between February and April 2025. 
    • “The FDA uses warning letters to flag significant violations after an inspection.”

From the public health and medical / Rx research front,

  • The AP reports,
    • “Utah has spent the past year fighting measles outbreaks — a grim milestone that could affect whether the United States can keep its measles-free designation. 
    • “More than 680 people have gotten sick since the state’s first outbreak began on June 20, 2025.
    • “Unlike measles outbreaks in Texas, South Carolina and Arizona, the spread in Utah has been tough to contain to one region — infecting undervaccinated communities in nearly every county. 
    • “Measles popped up in healthcare settings, big-box stores and restaurants, and youth sporting events. In February, an exposure at a state high school wrestling championship sparked at least 46 cases among attendees.” * * *
    • “More than 16% of the region’s kindergarteners were missing their measles vaccines in the last school year, according to state data. Statewide, 12.8% were missing their vaccine, putting the state far short of the 95% vaccination rate needed to prevent measles outbreaks.”
  • The American Medical Association lets us know what doctors want their patient to know about rib injuries.
    • “Rib injuries can range from bruises and stress injuries to fractures with overlapping symptoms.”
  • The Wall Street Journal tells us,
    • “Elementary school-age children are receiving GLP-1 weight-loss drugs such as Wegovy, despite that the medications aren’t being approved for obesity in this age group.
    • “Doctors prescribing GLP-1s to young children cite the severity of childhood obesity and its complications, seeing significant BMI decreases in some patients.
    • “Some doctors express concern about potential long-term effects on bone growth and brain development, while a guideline recommends medication only for children 12 and older.”
  • MedPage Today informs us,
    • “Adults ages 80 and older with unusually fast gait had about half the cognitive impairment risk as others, data from several studies suggested.
    • “Earlier research showed that super movers — people 80 and older who walk as fast as people 30 years younger — had a lower burden of disease, a healthier lifestyle, and a younger biological age.
    • “Findings suggested that mobility may reflect broad resilience across brain, cardiovascular, and muscle systems.”
  • and
    • “Previous research showed that combining the multicomponent blood-based biomarker Stockholm3 test with an MRI-targeted biopsy approach decreased overdetection of prostate cancers, while still detecting clinically significant cancers.
    • “In this analysis, the Stockholm3 test identified more clinically significant prostate cancers, while missing fewer cases, compared with standard PSA screening.
    • “These results support the use of the Stockholm3 test in the context of a risk-adapted screening approach, researchers said.”
  • and
    • “A major health system tested one multilevel approach to antithrombotic stewardship in the face of antiplatelet overprescribing among [direct oral anticoagulants] DOAC users.
    • “Antiplatelet use dropped following an initial educational outreach and a subsequent clinical pharmacist-facing electronic flag within a DOAC population management tool.
    • “The greatest benefit was observed in patients with stable [cornary artery disease] CAD, a group appropriate for antiplatelet deimplementation.”
  • STAT News notes,
    • “Pfizer said Monday that an experimental drug it hoped could replace a widely used chemotherapy in one of the most common forms of lung cancer fell short in a clinical trial.
    • “Expectations had been high that the drug, sigvotatug vedotin, could replace docetaxel, a chemotherapy initially approved in 1996. Last year Pfizer’s CEO, Albert Bourla, said on an earnings call the drug “could be a driver of growth later this decade.” In a note to investors in May, Leerink analyst David Risinger called the upcoming data readout a “major oncology catalyst” and said he had spoken to a doctor who was “optimistic” about its potential.” * * *
    • “The drug is an antibody-drug conjugate targeting integrin beta-6, a protein that is involved in tissue repair and is undetectable in normal cells but upregulated in cancer cells and is expressed in 90% of non-small cell lung cancer tumors. Pfizer was studying it compared to docetaxel in patients with locally advanced, unresectable, or metastatic non-squamous non-small cell lung cancer.
    • “But the drug did not result in a statistically significant improvement in overall survival over docetaxel. This was the study’s main goal, which means researchers will likely view other potentially encouraging conclusions from the clinical trial as requiring further proof.”

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

  • The Wall Street Journal reports,
    • “AbbVie agreed to acquire Apogee Therapeutics for about $10.9 billion to bolster its core immunology franchise.
    • “The deal includes Apogee’s experimental drug zumilokibart, a potential rival to Dupixent for moderate to severe atopic dermatitis.
    • “The acquisition, expected to close in the third quarter, will cut adjusted per-share earnings by 46 cents in 2027.”
  • STAT News adds,
    • “Pharma goes on a spending spree, snapping up biotechs in a hurry.
      • “M&A activity [like the AbbVie deal] has soared in the first half of the year.” * * *
      • “The amount of money put toward M&A in the first three months of 2026 was the highest seen since 2020, according to a report from PwC. 
      • “The flurry of M&A is also a welcome reprieve for biotech startup executives, who have struggled to finance their drug trials or early lab research, as well as venture capitalists searching for investment returns. It’s provided a lifeline to some biotech startups struggling to stay afloat.” 
  • Modern Healthcare relates,
    • “As the federal government expands access to weight-loss drugs for Medicare patients, Walmart and its Sam’s Club subsidiary are ramping up support services for beneficiaries who may be seeking the medications. 
    • “The Medicare GLP-1 Bridge program, which the Centers for Medicare and Medicaid Services is launching July 1, will allow eligible Part D beneficiaries access to certain GLP-1 drugs often used for weight management. 
    • “The retailers noted in a Monday news release Medicare patients may face hurdles understanding eligibility requirements, prescription coverage processes, provider documentation needs and pharmacy fulfillment options.
    • “The initiative, also launching July 1, will offer educational materials, consultations with pharmacists, assistance navigating government and healthcare resources, increased in-store support, digital health tools and connection to additional health services like vision care. 
    • “The retailer said in the release it is not responsible for eligibility determinations, coverage decisions and treatment recommendations.”
  • Beckers Hospital Review adds,
    • “CVS Health is expanding support services for patients using GLP-1 medications, including a new $50 monthly copay option for eligible Medicare beneficiaries and a $49 virtual weight management visit through MinuteClinic.
    • “CVS Pharmacy will begin participating in the CMS’ Medicare GLP-1 Bridge program July 1, according to a June 22 company news release. Established under agreements the Trump administration negotiated with Eli Lilly and Novo Nordisk in November, the program will set a $245 monthly Medicare price for Ozempic, Wegovy, Mounjaro and Zepbound, with patients paying $50 per month out of pocket. 
    • “The company also launched a new MinuteClinic virtual care offering available in 47 states and Washington, D.C. The service connects eligible adults ages 18-64 with licensed clinicians who can evaluate patients for weight loss treatment and, when clinically appropriate, prescribe FDA-approved GLP-1 medications. Visits cost $49 and do not require a recurring membership fee.
    • “CVS said the initiative also includes expanded pharmacist support and over-the-counter products designed to help patients manage common GLP-1 side effects and remain on therapy. The company plans to offer dedicated product displays in select stores focused on nausea, gastrointestinal discomfort, hydration and nutrition support.”
  • HR Dive notes,
    • “SHRM members are shaking up their prescription drug benefits strategies thanks to cost increases that are driven in part by a massive uptake of weight loss medications, analysts for the HR organization said during its 2026 annual conference on Tuesday.
    • “Specifically, GLP-1 drugs have become a “massive line item” for employers, said Kathryn Mayer, senior specialist, content at SHRM. The organization’s 2026 Employee Benefits Survey found that while close to half of the roughly 5,500 employer respondents covered GLP-1s for Type 2 diabetes management, only 15% did so for weight management.
    • “We’re finding that employers are struggling to fund GLPs,” said Calven Engstrom, a SHRM senior researcher. But given strong evidence of the drugs’ effectiveness and high demand from employees — a 2025 KFF poll found that 1 in 8 U.S. adults said they were currently taking a GLP-1 drug— organizations have to weigh competing interests.
    • “Many of these organizations are trying to balance employee health outcomes with the long-term affordability and sustainability of their typical health plan,” Engstrom said, adding that utilization rates for GLP-1s are probably among the most closely monitored by employers at the moment.”
  • Per a Fair Health news release,
    • “The national median total cost for a C-section for commercially insured patients staying in network is $19,911, and for vaginal delivery it is $15,728, according to FAIR Health’s Cost of Giving Birth Tracker. These figures reflect the national median allowed (in-network) amount for the procedures. 
    • ‘The Cost of Giving Birth Tracker is a free, interactive tool, updated today, that tracks the cost of giving birth state by state. Available on FAIR Health’s website fairhealth.org, the Cost of Giving Birth Tracker consists of heat maps that show state-specific and national median charge and allowed amounts for vaginal deliveries and C-sections. The tool draws on the national, independent nonprofit FAIR Health’s database of commercial healthcare claim records—the nation’s largest such repository, which is growing at a rate of more than four billion claim records a year.
    • “The Cost of Giving Birth Tracker includes inpatient and outpatient facility and professional costs. Services include the delivery itself (e.g., pharmacy, nursery, labor and delivery room, medical and surgical supplies, room and board for the mother), anesthesia, fetal nonstress tests, ultrasounds, laboratory work and a breast pump. The data come from the September 2025 release of the vaginal delivery and C-section FH® Total Treatment Cost benchmarks.”
  • Modern Healthcare informs us,
    • “Health systems are investing in remote patient monitoring despite reimbursement rates that often don’t cover technology and staffing costs.
    • “Providers are banking on remote monitoring programs’ long-term, less easily quantified benefits.
    • “Stanford Health Care, UMass Memorial Health, OSF HealthCare and others are using technology to keep an eye on patients outside hospital walls.”
  • Fierce Healthcare notes,
    • “Online portal messages sent to providers more than doubled between 2020 and 2025 as patients now have much more direct access to physicians. But there hasn’t been a corresponding drop-off in clinic visits as digital medicine is adding to clinicians’ workload rather than replacing in-person care, a new study finds.
    • “At least 12% of Americans now communicate with their healthcare providers about appointments, test results and ongoing treatments via secure online patient portals and health apps, according to a study led by researchers at NYU Langone Health and published today in the Journal of the American Medical Association (JAMA) online.
    • “Online portal messages jumped 153% from 2020 to 2025, from an average pace of 2.2 per year in early 2020 to 5.4 per year in late 2025. But these digital messages are not replacing in-office visits, which have returned to an average of between two and three per year per patient. In-person office visits saw a modest 17% increase, going from 2.37 to 2.77 per patient per year, during the study period.
    • “By contrast, total telephone calls decreased by 6% over the same period.”
  • and
    • “Nine months after announcing its seed funding round, Prosper AI banked $30 million to scale its agentic AI platform to power administrative tasks from patient scheduling to insurance verification and patient billing.
    • “While many voice AI companies focus on specific tasks, like patient scheduling or billing, Prosper AI was designed to manage the broader patient journey, according to executives. The platform answers patient calls, schedules appointments directly in the electronic health record, verifies insurance benefits, automates patient billing and contacts insurers on the phone when additional information is needed. 
    • “Prosper AI’s ambition is to build an AI workforce for healthcare operations teams, Xavier de Gracia, the startup’s co-founder and co-CEO, told Fierce Healthcare. Prosper AI first shared the funding news with Fierce Healthcare.
    • “We believe that three to five years from now, larger patient groups and health systems are going to have a layer of workforce that’s going to be AI, not only humans, and it’s going to complement the work that humans are doing, and we believe that EHRs are going to partner and are already partnering to build a layer on top of the electronic health record. Our vision is to be completely agentic.” 

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.” 

Thursday update

David Ermer–CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

  • Smart Brief reports,
    • “AHIP26: How data sharing, simplicity can improve care
    • “Panelists at the conference discuss the challenges that data fragmentation and siloing, as well as an unwieldy system, present — and offer solutions.”

From Washington, DC,

  • Govexec reports,
    • “A bipartisan trio of House lawmakers on Thursday reintroduced legislation aimed at expanding federal workers’ access to paid leave to handle illnesses and other circumstances not included in the 2019 law granting feds paid parental leave.
    • “The Comprehensive Paid Leave for Federal Employees Act, introduced by Reps. Don Beyer, D-Va., Brian Fitzpatrick, R-Pa., and Chrissy Houlahan, D-Pa., would grant federal employees up to 12 weeks of paid family leave each year to attend to a serious health condition or to care for a spouse, child or parent. The measure would also cover absences needed to help a family member who is the survivor of domestic violence, sexual assault or stalking, as well as to attend to a family member’s deployment into active duty military service.
    • “When Congress passed the 2020 National Defense Authorization Act, the House’s version included a provision providing 12 weeks of paid parental and family leave to feds. But during negotiations with the Senate, the measure was stripped down to remove the family leave portions, and feds became eligible for paid parental leave in October 2020.”
  • The Wall Street Journal reports,
    • “If you’re a senior, the Medicare plan you choose may have a major impact on whether you can get nursing-home care when you need it—and a new federal investigation shows the largest insurers had some of the highest denial rates.
    • “Medicare insurers had widely varying rejection rates for patients seeking nursing-home stays, as well as for long-term care hospitals and inpatient rehabilitation facilities, according to two new reports from the Office of Inspector General for the Department of Health and Human Services. * * *
    • “Appealing does appear to pay off: Of the 18% of patients who did appeal, nearly all of them were able to overturn the initial denial of skilled nursing care.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services June 11 released guidance detailing plans to implement new guidelines and standards for determining budget neutrality for Medicaid section 1115 demonstrations, which give states flexibility to design and test experimental approaches to Medicaid, including modifying eligibility, benefits, delivery systems and coverage, in ways not otherwise permitted under standard Medicaid authority. The guidance is intended to support implementation of a statutory requirement under the July 2025 reconciliation bill that the CMS Chief Actuary certifies that a demonstration is projected to be budget neutral, meaning it would not increase federal Medicaid spending relative to what expenditures would have been absent the demonstration. CMS said it plans to issue a rule with its proposed changes to budget neutrality.”
  • and
    • “The Centers for Medicare & Medicaid Services June 10 announced the establishment of a new Office of Health Technology and Products. CMS said the OHTP would modernize CMS healthcare technology and digital products, and transform platforms and services to support Medicare, Medicaid, the Children’s Health Insurance Program and other CMS-administered programs. The office will work closely with the CMS Chief Information Officer and be subject to CIO-led IT governance, cybersecurity, enterprise architecture, and capital planning and investment control responsibilities, among other areas. The OHTP will include new divisions, such as an Open Source Program group to develop policies and guidance around open-source frameworks, a Division of Data and Interoperability Platforms, and a Division of Policy responsible for the development of interoperability policies, regulations and sub-regulatory guidance. Additionally, the OHTP includes a Division of Core Products, responsible for the management and modernization of Medicare claims systems and provider-facing components such as the National Provider Directory. The OHTP and organizational changes became effective June 9.”
  • KFF explains how “Medicare Advantage Rebates Disadvantage Medicare’s Stand-Alone Drug Plan Market.
    • “Medicare Advantage Rebates Undermine Competition with Stand-Alone Drug Plans by Lowering Medicare Advantage Drug Plan Premiums.”
  • Beckers Hospital Review points out that “The 340B rebate fight escalates: 14 key developments.”
    • “From the first lawsuit to Lilly’s ultimatum: 18 months that reshaped the 340B program.”
  • Tammy Flanagan, writing in Govexec, discusses “Why Social Security’s funding gap matters to federal retirement.”
    • “Most federal employees under FERS rely on Social Security as part of retirement. The latest trustees report suggests the choices to preserve full benefits are getting tougher.”
  • Per a National Institutes of Health News release,
    • “National Institutes of Health (NIH) Director Jay Bhattacharya, M.D., today announced the selection of Raymond H. Jacobson, Ph.D., as the director of NIH’s Center for Scientific Review (CSR), which ensures expert and fair review of the tens of thousands of grant applications received by the agency each year. Dr. Jacobson will begin his role on June 14, 2026.
    • “Dr. Jacobson will continue strengthening NIH’s centralized peer review system so that we can continue backing the most scientifically meritorious research ideas in support of NIH’s mission,” said Dr. Bhattacharya. “His leadership will help ensure the first level of NIH review remains rigorous, fair, and transparent for all applicants.”
    • “Prior to his selection, Dr. Jacobson served as CSR’s acting director following the retirement of Dr. Bruce Reed. Dr. Jacobson helped guide NIH’s centralization of peer review, and as Acting Deputy Director of the NIH Office of Extramural Research in 2025, he advanced efforts to reduce administrative burden and address challenges faced by applicants. Additionally, he was the director of the CSR Division of Receipt and Referral beginning in December 2024, where he led efforts to simplify application receipt and referral policies.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “When millions of soccer fans descend on North America [beginning today] for the 2026 FIFA World Cup, they will bring more than team jerseys and national pride.
    • They will also bring the microbes that travel with people.
    • Public health officials have spent years preparing for the tournament, which is expected to draw visitors from more than 100 countries to the United States, Canada and Mexico. Although diseases such as Ebola and hantavirus have been in the headlines, public health experts say the diseases most likely to show up in clinics, emergency departments or urgent care centers are likely to be less exotic.
    • “Instead, their top concerns include measles, dengue, respiratory viruses and sexually transmitted infections that are already circulating. These diseases are likely to spread more easily as fans crowd into airports, hotels, stadiums and festivals.
    • “Measles is what I’m most worried about,” said Krutika Kuppalli, an infectious diseases physician and associate professor at UT Southwestern Medical Center in Dallas.
    • “Texas will host 16 World Cup matches in 2026 — more than any other state — with nine matches in the Dallas-Arlington area and seven in Houston. Dallas will host more matches than any other World Cup venue, including a semifinal. The first U.S. match is Friday, in Los Angeles, when the U.S. faces off against Paraguay.”
  • and
    • “Neuroscientist Miia Kivipelto’s life’s work has been about preventing dementia. Now, at 52, she has begun thinking more about her own vulnerability.
    • “Midlife is the time,” said Kivipelto, a neuroscientist who recently joined the Yale School of Nursing as the inaugural director of its Center for Aging Well in New Haven, Connecticut. “It’s the last best chance to lower risk.”
    • “The idea that dementia prevention may hinge on what people do in their mid-30s to their 60s is rapidly reshaping the field. Scientists increasingly believe the disease is driven not only by changes in the aging brain, but also by years of metabolic stress, inflammation and vascular damage accumulating across the body. Many researchers now think the biological process that leads to dementia begins 15 to 20 years before the first memory problems emerge. By the time symptoms become noticeable, the disease likely will already be well established.
    • “Neuroscientists now see midlife as a critical window when the brain becomes especially vulnerable to aging — but also more responsive to intervention. 
    • “The implications are profound: The ordinary habits of middle age may matter far more than scientists once realized, and cognitive decline may not be inevitable.”
  • Per a National Institutes of Health news release,
    • “A research consortium funded by the National Institutes of Health (NIH) has established a new framework to identify and catalog senescent cells – cells that stop dividing but remain active in the body. Because senescent cells accumulate with age and are thought to contribute to many age-related conditions, researchers are working to better understand the roles they play in health and disease. In a compendium of papers published in the June 11 issue of Cell, the consortium presents the first comprehensive atlas of senescent cells across the human body, a foundational step toward developing new therapies for age-related diseases.
    • ‘In healthy tissues, senescent cells support wound healing and serve as a defense mechanism by preventing the growth of tumors. They are normally cleared by the immune system, but as immune function declines with age, senescent cells accumulate in the body instead of being eliminated. Over time, these cells then release harmful signals that contribute to chronic disease and other age-related conditions. While removing these cells has been shown to diminish the impact of aging, their rarity and diversity have made them difficult to study.
    • “To address this challenge, the NIH Common Fund launched the Cellular Senescence Network (SenNet) program in 2021 to identify and characterize senescent cells across the human body.
    • “Through the new papers, researchers in the consortium are introducing the concept of “senotypes,” a new classification system that groups senescent cells based on where they are found in the body and the conditions surrounding them.
    • “By mapping where different senotypes are found and what makes them unique, we aim to build a more complete picture of senescent cells across the body,” said Nicole Kleinstreuer, Ph.D., NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives (DPCPSI), who leads the NIH Common Fund. “This knowledge could help researchers move toward more targeted therapies that focus on harmful cells while preserving beneficial ones.”
  • MedPage Today tells us,
    • “Research has suggested that consumption of sugar-sweetened beverages is linked to increased risks of certain cancers.
    • “A pooled analysis of 11 studies showed that sugar-sweetened beverage intake was not associated with overall liver cancer risk but was tied to increased risks of hepatocellular carcinoma and intrahepatic cholangiocarcinoma.
    • ‘Of note, there was no association between consumption of artificially sweetened beverages and liver cancer overall, or by subtype.
  • Health Day informs us,
    • “Sleep apnea might affect women worse than men.
    • “Women had similar outward symptoms of sleep apnea.
    • “However, they reported higher levels of side effects.”
  • STAT News lets us know,
    • “A targeted drug from Enliven Therapeutics induced molecular responses in nearly half of patients with advanced leukemia, including higher response rates in patients treated at an earlier stage of their disease.
    • “The updated early-stage study results reported Thursday for the Enliven drug, ELVN-001, compare favorably to a current blockbuster medicine sold by Novartis and an upstart experimental drug recently bought by Merck.” * * *
    • “Enliven has met with the Food and Drug Administration and received clearance to start a Phase 3 study later this year that will enroll patients with CML previously treated with one or more drugs. The study will compare ELVN-001 against a physician’s choice of currently approved CML drugs, excluding Scemblix.
    • “The company believes the addressable commercial market for ELVN-001 as a “second-line plus” treatment option for CML is worth $5 billion.”
  • Biopharma Dive adds,
    • “Takeda’s experimental autoimmune drug zasocitinib bested Bristol Myers Squibb’s marketed medicine Sotyktu in a head-to-head study in psoriasis, the company said Thursday.  
    • “Takeda didn’t provide detailed data but said that zasocitinib demonstrated statistical superiority against Sotyktu on all main and secondary study goals. After 16 weeks, zasocitinib helped completely eliminate the skin lesions in over a third of recipients, more than doubling what was seen with Sotyktu. It’s the second time Takeda’s drug has beaten an approved therapy, following positive results in a trial testing it against Amgen’s Otezla. 
    • “Zasocitinib is a newer kind of “TYK2 inhibitor,” a class of oral autoimmune medicines that have attracted significant industry investment in recent years. It’s become a star prospect for Takeda, which acquired the therapy from Nimbus Therapeutics for $4 billion upfront and started a series of high-stakes trials to establish its commercial potential. But zasocitinib is close to entering a crowded market that includes many other medications, among them a new pill from Johnson & Johnson.”
  • and
    • “An RNA drug Novartis acquired as part of its $12 billion bet on Avidity Biosciences succeeded in a trial of patients with a rare neuromuscular disease, Novartis said Thursday.
    • “Called delpacibart braxlosiran, the experimental drug met its primary biomarker endpoint in a Phase 1/2 study evaluating the treatment in a muscle-wasting disease known as facioscapulohumeral muscular dystrophy, or FSHD. The drug, a so-called “antisense oligonucleotide conjugate” or AOC, is designed to restore muscle function and help slow progression of the disease.
    • “Del-brax targets a gene called DUX4, which is expressed incorrectly in patients with FSHD.”

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

  • Modern Healthcare reports,
    • “Group healthcare costs are expected to rise 9% in 2027 as Americans use more services. 
    • “The growing use of expensive drugs, the proliferation of mental health issues and reimbursement pressures will drive healthcare cost inflation, according to a Thursday report from consultancy PwC.”
    • “Researchers spoke with actuaries at 27 health insurers that cover 103 million employer-sponsored members and 8 million Affordable Care Act enrollees to forecast healthcare inflation. 
    • “PwC projected an 8.5% increase for the individual market. In addition to the 2027 projections, the consultancy retroactively adjusted last year’s group cost growth estimate to 9% from 8.5% and the individual market projection to 8.5% from 7.5%.”
  • and
    • “U.S. companies plan to charge more for employee health plans next year, as soaring drug prices drive up insurance costs.
    • “Two-thirds of large companies expect to raise monthly premiums for employee health coverage through paycheck deductions in 2027, according to a survey of businesses with at least 500 employees by benefits consultancy Mercer. And about half (48%) of employers say they will make other changes, such as raising deductibles and copays, that will increase how much workers pay out of pocket for care.”
    • “It isn’t just employees who will be paying more. Health insurers are raising costs for employers, too, with the cost of group plans set to increase by more than 6% for the fourth year in a row, said Beth Umland, Mercer’s director of research. Annual increases previously hovered around 3% for more than a decade.
    • “Although employers initially tried to absorb those higher costs, they are beginning to pass them onto workers, Umland said. This year, employers expect to pay more than $18,500 per employee for health care benefits, a 6.7% increase from 2025 and the biggest jump in 15 years.”
  • MedCity News adds
    • “If you want to know where healthcare finance is headed, ask the people who lend hospitals money. 
    • “During a Tuesday panel at the HFMA Annual Conference in National Harbor, Maryland, two veteran healthcare credit analysts said they think the window for deliberate strategic action is closing faster than most health system leaders realize.
    • “We love incremental change in healthcare — it’s not going to work anymore,” said Kevin Holloran, senior director of nonprofit healthcare group at Fitch Ratings. “We’ve got to have some really bold thoughts and really bold moves if we’re going to be ready for 2030 and then beyond.”
    • “His urgency stems from a stark demographic reality. In 2030, the last of the Baby Boomer generation will officially reach age 65 and become Medicare-eligible. This is the same year that the most significant cuts from the federal budget reconciliation legislation will begin to bite.” * * *
    • “2030 scares me to death,” Holloran declared. “Right when you get fewer people in the workforce, you’re going to see your payer mix decline. You’re going to go from commercial to Medicare — and you’re not going to have enough people, as they’ve left the workforce.”
  • Healthcare Dive relates,
    • “Health plans are projecting commercial healthcare costs will rise 9% next year, driven in part by increased adoption of artificial intelligence billing tools by providers, according to a report released Thursday by professional services firm PwC.
    • “Nearly 70% of surveyed plans ranked providers’ use of AI documentation and coding products as a top three inflator next year, while about 20% called AI the number one inflationary trend. 
    • “Still, AI isn’t a major driver of growing healthcare costs compared with labor and supply cost inflation or increased healthcare utilization, said Glenn Hunzinger, U.S. health industries leader at PwC. “The ability to use technology and AI to more appropriately code or code things that they were never able to, that’s the trend we’re seeing,” he said. “It does have an impact on that 9%, albeit it’s not the biggest piece.”
  • Fierce Healthcare adds,
    • “Since launching eight years ago with an ambient medical transcription tool, Abridge has set is sights more broadly on building out a full-scale AI clinical assistant. The company is steadily developing tech and features to assist with billing, prior authorization and clinical decision making.
    • “Today, the company announced a major platform expansion to integrate payer and life sciences workflows. Described as an “AI-native clinician intelligence platform,” Abridge says it now connects care delivery, payment and evidence-based treatment.
    • “Abridge CEO and co-founder Shiv Rao, M.D., announced Thursday at an event in New York City that pharma giant Eli Lilly and Company made a strategic investment in the company to “support evidence-based care and research.” The financial details of the investment were not disclosed.”
  • Coviti points out,
    • “Improper use of modifier codes in radiology can lead to excessive billing, often misrepresenting radiology services and diminishing trust between providers and health plans. As new requirements and measures emerge, special investigative units (SIUs) should remain vigilant with claims analyses and proper documentation to reduce overpayments.
    • “This month’s edition of FWA Insights dives into outlier billing for modifier codes and excessive services in radiology, revealing the ramifications of medical coding discrepancies and providing practical steps to prevent fraud, waste, and abuse (FWA).”
  • Per an Institute of Clincal and Economic Research (ICER) news release,
    • “The Institute for Clinical and Economic Review (ICER) today released its revised Evidence Report assessing the comparative clinical effectiveness and value of vaccines for protection against Covid-19, including: Comirnaty® (Pfizer, BioNTech), Spikevax® (Moderna), mNexspike® (Moderna), and Nuvaxovid® (Sanofi).
    • “Covid-19 infections continue to occur year-round, sometimes leading to serious illness or death,” said ICER’s Chief Medical Officer, David Rind, MD, MSc. “For any preventive care, the goal is always to understand whether the potential benefits outweigh the potential harms. ICER evaluated the evidence for Covid-19 vaccines in 12 US sub-populations. Current evidence suggests that the greatest net benefit of Covid-19 vaccination is in pregnant women; infants aged 6 months to one year; and adults over the age of 65, with the net benefit increasing further with increasing age. Declining rates of serious Covid-19 year over year necessarily create some uncertainties. We hope this report will be a useful resource to policymakers and public health officials as they consider vaccination recommendations for Covid-19 for the 2026-2027 season.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC on June 25, 2026. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
    • “Register here to watch the live webcast of the virtual meeting.“
  • Fierce Healthcare tells us,
    • “Humana announced this week that it intends to divest its minority stake in Gentiva, the largest provider of end-of-life care in the country.
    • “The company said Wednesday that it has entered into a definitive agreement to sell off “all or substantially all” of its stake in Gentiva to a “consortium of investors.” The agreement puts the value of Humana’s stake in Gentiva at about $900 million, according to an announcement.
    • “Other financial terms related to the deal were not disclosed, and it’s expected to close in the third quarter of 2026, pending regulatory approval. Details on which investors are involved were also not made public.
    • “Humana said in the announcement that it plans to use the funds from the sale for “general corporate purposes,” and said it does not expect that the deal will have a material impact on its earnings for the year.”
  • BioPharma Dive informs us,
    • “Parabilis Medicines, a high-profile startup making medicines for “undruggable” targets, raised $670 million in an initial public offering on Wednesday, a record haul for a venture-backed biotechnology company.
    • “Parabilis boosted the size of its offering and ultimately sold 33.5 million shares at $20 apiece, eclipsing the amounts secured by Moderna in 2018 and Kailera Therapeutics earlier this year. It added another $75 million through a discounted private stock sale to new research partner Regeneron Pharmaceuticals.
    • ‘The IPO extends a streak this year for large new biotech stock offerings. So far in 2026 a dozen drugmakers have gone public and raised a median of about $300 million each, more than doubling the median total biotech startups secured in IPOs last year, according to BioPharma Dive data.” 
  • Per MedTech Dive,
    • “Danaher has completed its $9.9 billion takeover of Masimo, establishing itself as a competitor to Medtronic in the pulse oximetry market. 
    • “The completion of the purchase, which Danaher reported Wednesday, positions the company to start integrating Masimo in pursuit of more than $125 million of annual cost synergies and more than $50 million of annual sales synergies by the fifth full year after the deal closure.
    • “Masimo will slot into a diagnostics portfolio that features Radiometer, a Danaher business that specializes in blood gas analysis and other testing in acute care settings.”
  • and
    • “Insulet is developing an automated insulin delivery system that will be “completely different” than its competitors, Chief Medical Officer Trang Ly said in an interview after the American Diabetes Association’s Scientific Sessions. 
    • “The system, which Insulet calls “fully closed loop,” is for people with Type 2 diabetes and does not require carb-counting or insulin bolusing ahead of meals. Physicians also don’t need to program the starting settings, and dose titration is automated. 
    • “With our system there’s no bolusing at all. There’s actually no bolus button. … It’s completely different to what Medtronic and Tandem and everyone else is working on,” Ly said. “There are no settings for anyone to enter.” 
    • “Insulet shared results of its Evolution 3 study of the planned system at the conference on Saturday. The study built on previous results the company shared at another diabetes conference in March.”