Weekend Update

Congress

Weekend Update

David Ermer–Congress, FDA, Medical / Rx research, Obesity, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • The House of Representatives and the Senate are in session this week on Capitol Hill for Committee business and floor voting. Punchbowl News adds,
    • “It’s the last time this will happen until the week of Sept. 14, nearly two months from now.
    • “The Senate will be in through Aug. 7, while members of the House are leaving for five weeks starting on Thursday. Yes, it’s only mid-July, but the House won’t be back until Aug. 31.”
  • Noteworthy Committee hearings include:
    • House Committee on Oversight and Government Reform
    • Wednesday July 22, 2026 10:00 AM Local Time | 2154 Rayburn House Office Building, Washington, D.C.
    • Markup: the Full Committee to consider the following: 1) H.R. 6610, Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act]; 2) H.R. 9720, D.C. Taxing Authority Review Act; 3) H.R. 9725, Restoring Integrity and Efficiency to Inspector General Oversight Act of 2025; 4) H.R. 9643, Comment Integrity and Management Act; 5) H.R. 9741, To name the DC Tuition Assistance Grant program the “Eleanor Holmes Norton District of Columbia Tuition Assistance Grant Program”; 6) Several postal naming measures.
    • Related Items: H.R.8359 , H.R.9741 , H.R.8945 , H.R.9643 , H.R.9725 , H.R.4283 , H.R.8326 , H.R.6610 , H.R.8999 ,H.R.9026 , H.R.6006 , H.R.9720 , H.R.9570 , H.R.7365 , H.R.8419
    • Meeting Details
      • The FEHBlog expects that this anti-competitive FEHB bill HR 6610 would increase the cost of prescription drugs in the FEHB and PSHB programs.
      • The meeting details note;
        • H.R. 6610, Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act]
          • A.Summary
            • The bill proscribes terms, requirements, and prohibitions for the Federal Employee Health Benefit (FEHB) program plan contracting with Pharmacy Benefit Managers (PBMs). Specifically, the bill requires PBMs to reimburse pharmacies and effectively apply the amount of pharmaceutical manufacturer rebates to the amount beneficiaries pay for respective prescription drugs. The bill prohibits PBMs from “steering” beneficiaries towards certain pharmacies and imposes noncompliance penalties, subject to specified hearing and appeals processes.
          • B. Amendments
            • The Chairman will offer an ANS.
    • Senate Committee on Health, Education, Labor, and Pensions
      • Thursday July 23 9:47 AM (EDT) – Senate | 430 Dirksen Senate Office Building, Washington, D.C.
      • Open Business Meeting: Business meeting to consider the nominations of Sean Kaufman, of Georgia, to be Assistant Secretary for Preparedness and Response, Erica Schwartz, of Florida, to be Director of the Centers for Disease Control and Prevention, both of the Department of Health and Human Services, and Keith Sonderling, of Florida, to be Secretary of Labor.
      • Related Items: PN1129 , PN932 , PN937-3
      • Meeting Details

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Taylor Farms said that the Food and Drug Administration has apologized after the agency walked back an earlier statement that the parasite linked to an outbreak affecting thousands of people had been detected on a sample of its lettuce.
    • “The FDA on Sunday said it has yet to identify the presence of cyclospora on samples of lettuce from the company despite recent tests. The agency now deems the detection that it reported Saturday a false positive after laboratory experts reviewed the sample results.
    • “Taylor Farms, which supplies some of the country’s biggest retailers and restaurants, makes a range of products from salad kits to vegetable blends. Government agencies had linked shredded iceberg lettuce—served at locations of the restaurant chain Taco Bell—to reports of foodborne-illness in five states. The company said it initiated a recall “in an abundance of caution” of its iceberg lettuce grown and processed in central Mexico. Many of its other products remain on store shelves.”
  • FEHBlog observation: Huh? Have cyclospora cases been dropping since the recall?

From the public health and medical / Rx research front.

  • WABC News in New York City reports,
    • “Officials have released new information about the second person who has died in connection to the ongoing Legionnaires’ disease outbreak on the Upper East Side.” * * *
    • “As of Saturday night, 72 people have been diagnosed with Legionnaires’ disease, and nine people are hospitalized in association with this cluster.
    • “The tragic announcement comes just days after the city revealed more than 45 additional positive tests for Legionella bacteria linked to cooling towers on the Upper East Side.
    • “So far, they have ordered a total of 76 buildings to clean their cooling towers as they work to contain the ongoing outbreak.
    • “Legionnaires’ disease is treatable but 10% of people will die due to complications from the illness, according to the U.S. Centers for Disease Control and Prevention.”
  • Medscape relates,
    • “An imaging-derived measure, the sarcopenic obesity index, predicted heart failure, cardiovascular death, and all-cause mortality better than traditional body composition measures such as BMI and waist-based ratios, capturing the combined burden of excess adiposity and low muscle mass.”
  • Beckers Behavioral Health tells us about “24 new behavioral health study findings to know,”

From the U.S. healthcare business front,

  • Beckers Hospital Review provides us with 10 things to know about the hospital profitability divide.
  • Beckers Physician Leadership points out
    • “More than 63% of physicians are already working in locum tenens or considering taking on a locum tenens role within the next five years, according to a report from Doximity.” Locus tenems means temporarily filling in for other clinicians to maintain continuity of care. Specialized staffing companies manage these fill ins for hospitals and medical practices.

Friday report

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

Simplicity is a virtue.

From Washington, DC

  • Politico reports,
    • “House GOP leaders released text Friday for a bill to fund the vast majority of the federal government from the start of the next fiscal year on Oct. 1 until after the midterm elections — bypassing the bipartisan appropriations process and daring Democrats to pick a shutdown fight months before voters head to the polls.
    • “Speaker Mike Johnson said Thursday he plans to put the legislation on the floor next week.
    • “The measure would fund the government through Dec. 4 and, as Republican leaders promised, would not include additional policy riders or unrelated provisions.”
  • Roll Call offers a wrap up of this week’s activities on Capitol Hill.
  • STAT News relates,
    • “Pretty much everyone who cares about public health agrees that it’s a good idea to help people quit smoking, the No. 1 cause of preventable death in the U.S. Doctors may soon get some extra encouragement to lend a hand, thanks to proposed changes in Medicare’s physician fee schedules.
    • “Physicians who offer counseling on quitting cigarettes or other tobacco products during visits with patients would get a 19% increase in reimbursement, according to a few paragraphs buried in the 1,592-page document released this week. The same adjustment would also apply to assessments of, and interventions for, alcohol and substance misuse during doctors’ visits.
    • “Given the evidence supported role these services play in preventing and managing chronic disease […] we believe that valuation should more accurately reflect the clinical intensity and work associated with these time-based services,” the proposal from the Centers for Medicare and Medicaid Services explains. Comments on the proposal are due Sept. 14. 
    • “The prioritization of cessation as a service is long overdue, and we’re very excited about it,” said Anne DiGiulio, the American Lung Association’s senior director of nationwide tobacco cessation and health policy.”
  • Health Day adds,
    • “For people assigned to smoking very low nicotine-content cigarettes (VLNCs), there is minimal evidence for compensation for reduced nicotine levels, according to a review published online July 15 in JAMA Network Open.
    • “Rachel L. Denlinger-Apte, Ph.D., M.P.H., from the Wake Forest University School of Medicine in Winston-Salem, North Carolina, and colleagues examined whether people who smoke may increase their smoking to compensate for the reduced nicotine levels when smoking VLNCs for prolonged periods. Data were obtained from 17 randomized controlled trials published between 2010 and 2024, representing 5,500 adolescents and adults who smoked cigarettes daily or nondaily. A subset of 2,454 participants from seven trials were included in the pooled meta-analysis.”
  • Food Dive relates,
    • “The FDA’s acting head of food on Tuesday [July 14] admitted crafting its highly anticipated definition of ultraprocessed foods is proving “quite challenging,” though he added it’s still a “priority” for the agency.
    • “Just because it’s a tough challenge, it doesn’t mean it’s something that we should shy away from,” Donald Prater, FDA’s acting deputy commissioner for food, said during a keynote at the IFT First conference in Chicago.
  • Genetic Engineering and Biotechnology News adds,
    • “Ketogenic diets, originally developed in the 1920s to treat epilepsy, have been adapted in the past few decades as a strategy to lose weight or increase lifespan. This type of diet (a high percentage of fat, low percentage of carbohydrates, and normal or reduced amounts of protein) forces the body to burn fatty acids for energy in place of carbohydrates such as glucose. Burning these lipids produces ketone bodies—primarily β-hydroxybutyrate (BHB) and acetoacetate—as byproducts of fatty acid metabolism. The impact of ketogenic diets on the gastrointestinal tract remains poorly understood.
    • “In recent years, scientists investigated whether this type of diet might affect the development of cancer. While some research has shown that the diet may protect against the development of colon cancer, a new study suggests that in the small intestine, a ketogenic diet may increase the risk of cancer—with a mechanism through fatty acid oxidation rather than ketone metabolism.”
    • “This work appears in Nature in the paper, “Ketogenic diet mediates intestinal tumorigenesis through lipids not ketones.”

From the Food and Drug Administration,

  • Fierce Pharma reports,
    • “With two approved medicines to treat primary immunoglobulin A nephropathy (IgAN) and a third therapy in phase 3 testing, Novartis is on its way to cornering the market for the indication.
    • “On Friday its first drug to hit the market for IgAN, Fabhalta, gained a full blessing from the FDA, with the U.S. regulator converting the drug’s accelerated approval into a traditional nod. Fabhalta is now endorsed to slow kidney function decline in adult IgAN patients who are at risk for disease progression. 
    • “The original, speedy IgAN approval for the first-in-class factor B complement inhibitor came two years ago to reduce proteinuria.”
  • Cardiovascular Business relates,
    • “The U.S. Food and Drug Administration (FDA) has shared updated recommendations about recalled thoracic stent grafts. Customers were previously told they could still use the devices as long as they were aware of the risk and knew how to respond if an issue occurred. Now, however, the FDA is emphasizing that these devices should be returned to the manufacturer and not be used to treat any other patients.”

From the judicial front,

  • Healthcare Dive reports,
    • “A federal judge has temporarily halted provisions of a rule from the Trump administration meant to reshape the Affordable Care Act exchanges days before they were scheduled to go into effect.
    • “On Thursday, a Maryland district court determined the coalition of cities and provider groups that filed a lawsuit challenging the rule would suffer “irreparable harm” from the policies, including the expansion of bare-bones catastrophic coverage and stricter verification of enrollees’ eligibility for subsidies.
    • “The stay is a victory for insurers, given it staves off further disruption to the already destabilized ACA marketplaces. However, the relief may be short-lived, as some of the policies codified in the GOP’s “Big Beautiful Bill” will be enacted in 2028.”

From the public health and medical / Rx research front,

  • The Centers for Medicare and Medicaid Services announced today,
    • “As of July 17, 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 very low and stable nationally but is beginning to show early signs of an increase, mainly in the South.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV), a respiratory virus that can cause illnesses such as croup, is elevated nationally. Rhinovirus/enterovirus (RV/EV) activity is elevated in some regions. Whooping cough (pertussis) continues to circulate at lower levels compared to post-pandemic peaks.”
  • The University of Minnesota’s CIDRAP reports,
    • “With 29 newly confirmed cases, the the US measles total is just 29 cases short of last year’s sobering total, the Centers for Disease Control and Prevention (CDC) said in an update today.
    • “The CDC announced 2,260 confirmed cases so far in 2026, all but 15 of them locally acquired. The total for all of last year was 2,289 infections, which was the most since 1991. The country could lose its measles elimination status this fall, which it gained in 2000.
    • Of the 2,260 cases for the year, 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 10% 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.”
  • MedPage Today adds,
    • “Declining U.S. vaccination rates have led to a resurgence in large measles outbreaks.
    • “Two papers examining South Carolina and Utah’s outbreak showed that hypoxemia and pneumonia were the most common conditions leading to hospitalization for measles.
    • “In the South Carolina report, two of 13 hospitalized patients developed measles encephalitis, a life-threatening complication that can cause brain damage.”
  • The American Hospital Association points out,
    • “A Centers for Disease Control and Prevention report released July 16 found that wastewater surveillance failed to detect an internationally circulating measles genotype that accounted for about 5% to 10% of U.S. measles cases in 2025, highlighting potential challenges of using wastewater surveillance as a public health tool. The report said that of two unrelated measles cases reported to the Wisconsin Department of Health Services in February 2026, wastewater surveillance detected one case before the case was reported. The second, caused by the international B3 genotype, was undetected. Public health officials later released a modified laboratory procedure that improved the detection of the B3 genotype. The CDC said that wastewater testing should be standardized and revalidated against circulating viruses and supported by publicly available whole-genome sequencing data.”
  • The Washington Post reports,
    • “Taylor Farms announced Friday that it is “voluntarily removing all iceberg lettuce sourced from central Mexico from the U.S. market,” after federal investigators identified some of the lettuce it provided to Taco Bell restaurants as linked to one of the largest U.S. outbreaks of cyclosporiasis this summer. 
    • “The company said in a statement that it made the decision based on information provided by the Food and Drug Administration, whose investigators had traced the outbreak to “a specific independent farm” representing less than 1 percent of the U.S. iceberg lettuce supply. The company added that it would remove all iceberg lettuce from the region indefinitely “out of an abundance of caution.”
    • “The company said no other Taylor Fresh Foods products across the country are impacted. It said no Taylor Farms branded salad kits contain iceberg lettuce.” * * *
    • “Other companies have begun to respond to a parasite-borne illness that has sickened thousands, and the federal health investigation has widened beyond Taco Bell restaurants. Sysco, one of the world’s largest food suppliers, on Thursday voluntarily stopped distributing certain iceberg lettuce products from Mexico after the agency said it was tracing where the contaminated lettuce may have been distributed throughout the food supply.”
  • The Wall Street Journal explains “What to Know About the Cyclosporiasis Outbreak and How to Stay Safe”
    • “More than 30 states have reported cases of the illness. Taco Bell’s lettuce is linked to cases in at least five states.” * * *
    • “Norovirus is a highly contagious virus that can cause vomiting and diarrhea, but it typically comes on within 12 to 48 hours of exposure and lasts one to three days. 
    • “Cyclospora, on the other hand, can cause weeks of relapsing diarrhea where someone gets sick, feels better, and then gets sick again, said Caitlin Rivers, director of the Center for Outbreak Response Innovation and an associate professor at the Johns Hopkins Bloomberg School of Public Health. “It lasts much longer than a stomach bug where you’re sick for a day and you bounce back.” 
    • “Another big difference: Many foodborne illnesses, like norovirus, are highly infectious and spread between humans through something as simple as touching a doorknob. 
    • “One piece of good news: Cyclosporiasis is rarely contagious between people.” 
  • The Washington Post tells us,
    • “Plumes of thick, toxic wildfire smoke from fires burning in Canada are billowing into the United States. The phenomenon, where smoke blots out the blue sky overhead, making the air appear milky-white or even orange, has become a relatively regular fixture of summers where out-of-control wildfires in the West bring noxious smoke downwind.” * * *
    • “There’s essentially a west-to-east conveyor belt that’s pumping high-altitude smoke eastward. That’s because the smoke is surfing the jet stream, a river of swiftly moving winds in the upper atmosphere. The jet stream is cresting around a ridge of high pressure parked over the central states.
    • “The smoke is also being steered by persistent troughing, or areas of low pressure, east of the Hudson Bay in northern Quebec. That counterclockwise-spinning low induces northwesterly winds, which are winds that blow from the northwest and pump the smoke in a southeast direction.
    • “That brings surface-level smoke into the Lower 48 in copious quantities. Medium-range weather models suggest a similar pattern continues into late July, meaning smoke will continue taking this trajectory.” * * *
    • “As of early Friday morning, Chicago, Detroit, D.C. and New York City were the most polluted major cities in the world — exceeding Delhi and Kolkata, India; Jakarta, Indonesia; and most major cities in China.”
  • Kaufmann Hall notes,
    • “Less than half of adults in rural communities have had a routine medical visit or cancer screening in the past year, according to a recent survey by the Prevent Cancer Foundation. The broader survey of U.S. adults found that half of all respondents expressed concerns and confusion about the cost of medical screenings. Nearly 15% of respondents also expressed concerns about the costs of follow-up appointments and lost wages. The news comes as the American Association for Cancer Research’s latestprogress report finds that declines in cancer death rates have been slower among rural residents than those living in urban areas.”
  • The Wall Street Journal journalist lets us know “I Tested My Blood for Microplastics. I Got a Number, but Few Answers.
    • “Plastics are accumulating in our bodies, but scientists aren’t sure how bad that is for our health.”
    • “Microplastics are ubiquitous. Bottled water and processed food are big culprits. So is clothing, furniture and just about everything else.
    • “It’s hard to find things that are not made of plastic,” says Phoebe Stapleton, an associate professor in the department of pharmacology and toxicology at the Ernest Mario School of Pharmacy at Rutgers University. 
    • “And they get into our bodies through both ingestion and inhalation. There hasn’t been a tissue or organ in the body where microplastics haven’t been found. Lungs, heart, kidneys, liver, brain, testicles, the fluid in our eyes, and ovaries—all have microplastics, says Stapleton.
    • “No wonder there’s more interest in testing. The blood test has been commercially available since 2023. I purchased it for $135 through Bryan Johnson’s longevity health site, Blueprint.” 
  • STAT News informs us,
    • “For the last year, a small California startup has been making extraordinary claims about the ability of its technology to potentially treat Duchenne muscular dystrophy — and maybe a slew of other genetic diseases, too.
    • “The company, Sonothera, does not yet have clinical data. But it’s presented data in animals so stunning that other experts can’t quite wrap their minds around it.” * * *
    • “The technology in question is ultrasound — yes, the same technology used for imaging pregnancies. Sonothera is using it to deliver replacement genes into the muscles of mice and monkeys.
    • “The approach marks a radical departure in the gene-therapy field, which has long relied on viruses to ferry genes into cells. Those viruses, while occasionally powerful, have severe drawbacks. They can only deliver genes of a certain size and can only be administered once, after which patients develop immunity. If the first treatment didn’t get enough of the gene to enough cells — well, you’d better have some other fix.” * * *
    • “Answers may come soon in clinical trials. Sonothera’s backers point to multiple pieces of supporting evidence, including improved muscle function in mice. And the company is still optimizing its therapy. 
    • “For humans, Sonothera’s goals are far more modest than what was achieved in some of its studies: a 15% increase in dystrophin, while creating protein in at least 20% of a patient’s muscle fibers.”
  • Per BioPharma Dive,
    • “GSK is discontinuing trials of an experimental chronic cough medicine it bought in a $2 billion deal three years ago, announcing Friday that camlipixant had failed to meet nearly all of the goals in two Phase 3 trials. The British pharmaceutical giant said the “limited efficacy demonstrated is unlikely to transform patient care.”
    • “The termination closes a blockbuster opportunity for GSK, which hoped to add camlipixant to a portfolio of respiratory drugs that includes asthma and COPD treatments like Trelegy and Anoro. The company said it is continuing Phase 2 trials in people with irritable bowel syndrome.
    • “Camlipixant’s failure follows that of two others in the “P2X3 antagonist” class that were developed by Bayer and Merck & Co, the latter of which spent more than $500 million to gain control of its drug. The setback also clears away a threat to Trevi Therapeutics, which is advancing a different type of treatment in chronic cough.”
  • and
    • “Merck & Co.’s partner Kelun-Biotech said its experimental medicine sac-TMT helped patients with a form of lung cancer stave off disease progression better than a standard regimen including chemotherapy in a new Phase 3 study.
    • “The trial, conducted in China, included patients with locally advanced or metastastic non-squamous non-small cell lung cancer whose tumor cells don’t have enough of a protein called PD-L1. When working properly, PD-L1 helps the immune system focus on killing diseased cells instead of healthy ones. But too much or too little of this protein can throw the system off kilter.
    • “Kelun previously saw success with sac-TMT in PD-L1-positive patients and is now tackling the “negative” patients who represent what it calls a “therapeutic bottleneck.” Sac-TMT is the first so-called antibody drug conjugate to succeed in a Phase 3 study of this patient population in combination with an immunotherapy like Keytruda, Kelun said Tuesday [July 14].”

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

  • Beckers Hospital Review reports,
    • “Vascular surgery is projected to have the highest shortages of physicians, the Health Resources and Services Administration’s National Center for Health Workforce Analysis found.
    • “The HRSA workforce simulation model assesses the adequacy of the nation’s projected workforce supply for 35 physician specialties from 2023 through 2038.
    • “Across all specialties, there is a projected shortage of 141,160 full-time equivalent physicians by 2038. Only five of the 35 physician specialties are expected to see a surplus of workers. The shortages in some specialties can be mitigated by increasing the use of nurse practitioners and physician assistants, according to the center.”
  • and 
    • “Novant Health is the latest health system to launch round-the-clock virtual primary care that uses AI to assess patients before connecting them with a clinician, joining at least seven other systems offering similar 24/7 care models.”
    • The article lists seven other health systems using this model.
  • and
    • The pandemic revealed a demand for telehealth, forcing the healthcare industry to rethink how and where care could be delivered. 
    • Patients and providers alike discovered that high-quality care doesn’t have to mean an in-person visit. Hospitals, health systems and healthcare companies rapidly expanded their telehealth offerings accordingly.
    • The momentum hasn’t slowed, and today’s telehealth landscape is defined by smarter platforms, broader access and solutions designed to bring expert care directly to patients regardless of geography, mobility, or circumstance. 
    • [The article lists] 272 telehealth companies to know. 
  • STAT News relates,
    • “Every day, doctors turn to specialized calculators to make decisions about their patients’ care. Kidney performance? There’s a calculator for that. Chance of a successful vaginal birth after a previous C-section? There’s a calculator for that. 
    • “Medicine has accumulated hundreds of these clinical scores and decision-making tools, and their numbers continue to grow along with the scale of clinical data. But just because a calculator exists doesn’t mean doctors should always trust its output. 
    • “In clinical practice, a lot of the tools that we use, we genuinely have no idea how limited it is in its validation,” said health systems researcher and gastroenterologist Shazia Siddique. That is why MDCalc, the company Siddique joined last year, is launching a quality-rating system to apply to the more than 800 clinical tools and calculators that doctors use through its site.”
  • Per Fierce Pharma,
    • “Following the Independence Day holiday, the overall GLP-1 market was down 5.1% week over week as measured by total prescriptions across obesity and diabetes uses, according to IQVIA data cited by Citi.
    • “In the obesity field specifically, total scripts for Eli Lilly’s Zepbound shrank by 3.1% sequentially to a little below 660K, while Novo Nordisk’s Wegovy dipped 4.4% to about 448.5K.
    • “Against this backdrop, Lilly’s oral Foundayo seemed to enjoy a small inflection point, with a total 24,303 scripts notably breaking away from its roughly 20K level in the prior five weeks.  
    • “Meanwhile, joining the bigger trend, Wegovy pill scripts dropped to 147.5K during the week, versus about 153K the prior week or 161.5K at its peak. But the contribution of the oral version to the overall Wegovy scripts remained stable at around a third, per Citi’s note.” 
  • Per BioPharma Dive,
    • “Cash-strapped biotechnology company Jasper Therapeutics has gained a financial lifeline through a merger with a privately held immune drug developer.
    • “Jasper said Thursday it has completed an all-stock acquisition of Kira Pharmaceuticals and, alongside that deal, raised $132 million in a private stock offering. The new funding will enable Jasper, which had just $14 million in cash at the end of March, to operate through the second half of 2028. The combined company will retain the Jasper stock ticker, but have a bigger pipeline that now includes two immune disease drugs Kira has been developing.” 

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.” 

Midweek report

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

Simplicity is a virtue.

From Washington, DC,

  • Fedweek reports,
    • “Although it is only mid-July, time is running short for Congress to act on bills to fund federal agencies after the September 30 end of the current fiscal year, as well as on the annual must-pass defense authorization bill.
    • “While schedules are subject to change, after next week Congress is scheduled to be in session only four weeks in September until the week after the November elections. Of the dozen regular appropriations bills, the House has passed just [three] and the Senate none.
    • “Typically, in such a scenario Congress would extend current funding levels until sometime in November or even December to buy more time. However, the record-setting shutdown of last fall and the DHS-only shutdown of earlier this year have shown that both Congress and the White House are willing to allow funding to lapse in pursuit of budgetary and program goals.”
  • Healthcare Dive relates,
    • “Physicians billing Medicare would see a pay dip next year as part of a sweeping reimbursement rule that also aims to increase provider participation in accountable care organizations and overhaul quality reporting.” * * *
    • “Provider groups slammed the proposal, arguing that the payment cut would destabilize physician practices and limit investment in primary care.
    • “The updates “fall well short of what it actually costs our members to deliver care,” said Dr. Jerry Penso, president and CEO of the American Medical Group Association.”
  • Fierce Healthcare adds,
    • “New legislation introduced in the House by leaders of both parties’ doctors caucuses takes a crack at providers’ long-requested overhaul of annual physician payment adjustments.
    • “The Patients First Act (PDF of bill text) would eschew the year-to-year reimbursement formula established under 2015’s Medicare Access and CHIP Reauthorization Act (MACRA) to instead tie physician reimbursement to an inflationary measure. The formula would take the Medicare Economic Index and subtract one percentage point. The approach answers years of alarm from physicians and medical groups that the costs of running a practice have grown far faster than reimbursement.
    • “We often talk about expanding access to high-quality care, but without meaningful Medicare reimbursement reform, that mission becomes nearly impossible to achieve,” Rep. John Joyce, M.D., R-Pennsylvania, one of the bill’s cosponsors, said in a statement. “Putting patients ahead of politics, we worked together to develop this comprehensive legislation to address a system that has for far too long undermined patient access to affordable, physician driven care within their communities.” * * *
    • “Jerry Penso, M.D., president and CEO of The American Medical Group Association (AMGA), said the trade group was particularly encouraged by the inflation-tied pay updates and formal rulemaking requirement for mandatory models.  “We appreciate this physician-led policymaking process, as these members of Congress know firsthand how federal policies impact medical practices,” Penso said.”
  • Roll Call lets us know,
    • “A bipartisan pair of House members is introducing legislation aimed at treating millions of Americans of a deadly-but-curable liver disease, the culmination of a yearslong push from public health advocates.
    • “The bill, sponsored by Reps. Mariannette Miller-Meeks, R-Iowa and Diana DeGette, D-Colo., would create a national hepatitis C elimination program to expand testing and treatment especially for people least likely to access it, including those who are incarcerated, uninsured, low-income, or receiving care through the Indian Health Service.
    • “The legislation would also direct the federal government to enter into five-year subscription agreements with at least one drug manufacturer to purchase unlimited hepatitis C treatments at a fixed price. That could make a big difference in expanding access to the drug, which can cost tens of thousands of dollars per course of treatment.
    • “Hepatitis C is beatable. We have the tools to eliminate it, and this bill puts them within reach of the Americans who need them most,” Miller-Meeks said in a statement.”
  • STAT News tells us,
    • “Medicare regulators on Tuesday proposed to ban vendors from providing remote patient monitoring services on behalf of doctors, a major policy change for a rapidly growing care model that’s been the subject of increasing scrutiny.
    • “Medicare has covered remote patient monitoring since 2018, and payments ballooned to over $500 million in 2024. The proposed change follows widespread concern from the health department’s watchdog, academics, and insurers that the current remote monitoring system is paying for low-value services. If finalized, the rule would impact a large percentage of remote monitoring care as it’s delivered today.”
    • “The update comes as the Trump administration moves to rein in fraud and wasteful spending in the Medicare program. The Centers for Medicare and Medicaid Services also recently launched an alternative model to pay for digital health services. 
    • “Currently, health systems and other primary care providers are allowed to bill when they use a vendor to help patients manage conditions using data collected at home. In one common use case, a vendor’s clinical staff can keep tabs on a patient’s home blood pressure readings and provide guidance to help get a patient’s hypertension under control. If needed, the patient can be referred back to their doctor. 
    • “The proposed change, included in a draft fee schedule from CMS, would require the remote monitoring services to be performed by clinical staff employed by the health care provider billing Medicare.”  
  • Fierce Healthcare adds,
    • “The Centers for Medicare and Medicaid Services has joined lawmakers who have questioned the role of the American Medical Association’s (AMA’s) Current Procedural Terminology (CPT) in government healthcare.
    • “Tuesday’s Calendar Year 2027 Physician Fee Schedule proposed rule included, among other policy proposals, a call for public comment “on a number of areas regarding the influence of the CPT coding system and AMA process on physician payment policy as part of the Secretarial priority to Make America Healthy Again.” * * *
    • “CMS asked the public to describe any evidence of “harms or challenges associated with AMA’s monopoly over CPT-4 licenses,” and whether the development of new codes is based on identified medical necessity. The agency also asked for input on any potential alternatives to the AMA’s standards and processes, and floated the Internal Classification of Diseases, 10th Revision (ICD-10) procedure code as an option worth considering.”
  • Per the American Hospital Association News,
    • “The AHA July 15 responded to a request for information from the Centers for Medicare & Medicaid Services on the Affordable Care Act’s Essential Health Benefits framework, which creates the guardrails for defining comprehensive insurance coverage. The AHA supported updating the EHBs to reflect a changing healthcare landscape but cautioned CMS against changes to the EHBs that would dilute coverage, noting that affordability cannot be measured by premiums alone and that adequate coverage is essential for true affordability.”
  • and
    • “The Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, and the Department of Health and Human Services July 15 released a request for information on topics regarding Clinical Laboratory Improvement Amendments of 1988 regulations. Topics include breath testing, laboratory processes and procedures, emergency preparedness, biosafety and biosecurity, cybersecurity and specialty testing areas. The agencies will accept comments through Sept. 14.”
  • Per a U.S. Office of Personnel Management news release,
    • “The US Office of Personnel Management (OPM) today announced the launch of the Guide to Processing Personnel Actions (GPPA) Navigator, a new digital tool that modernizes how federal Human Resources (HR) professionals access and apply personnel action guidance.
    • “The GPPA Navigator transforms decades of document-based guidance into an intuitive, searchable digital experience, giving more than 40,000 federal Human Resources specialists across government faster access to the codes, authorities, and policy guidance needed to process personnel actions accurately and consistently.
    • “The launch coincides with OPM’s comprehensive review and modernization of the Guide to Processing Personnel Actions, which streamlined content, removed outdated material, and incorporated recent policy updates to better serve today’s federal workforce.”

From the Food and Drug Administration front,

  • Fierce BioTech reports,
    • “After pausing a controversial policy to publicly release drug rejection letters in April, the FDA today confirmed that the pause has been lifted and that more documents will be coming down the line.
    • “A spokesperson for the Department of Health and Human Services told Fierce last week that the policy to release complete response letters (CRLs) in real-time had been temporarily suspendedin April, the first time the pause was confirmed. Mere days later, the agency dropped a new batch of 14 CRLs, raising questions about the policy’s status.
    • “FDA will continue to proactively publish appropriately redacted CRLs, building on the batch released on July 10,” the spokesperson told Fierce today.”
  • Reuters relates,
    • “The U.S. FDA has approved Celcuity’s (CELC.O) drug for an advanced form ​of breast cancer, the regulator said on Tuesday, making it the ‌company’s first product to gain market entry.
    • “The Food and Drug Administration’s approval was based on ​late-stage data showing the drug, gedatolisib, branded as Revtorpyk, when combined with ​Pfizer’s (PFE.N) Ibrance and fulvestrant, reduced the risk of disease progression or ⁠death by 76% compared with fulvestrant alone.”

From the U.S. public health and medical / Rx research front,

  • STAT News reports,
    • “Sen. Lindsey Graham’s death Saturday at age 71 following an aortic dissection has focused attention on the life-threatening condition. Details about his diagnosis and treatment are not available while a final death certificate is pending, but experts agree on both how serious it is and how suddenly it erupts after a long prelude.” * * *
    • “Echocardiograms and CT scans offer a picture of blood vessel health, with guidelines based on vessel width dictating when surveillance should begin. Surgery can correct the problem, but it’s a major, high-risk operation to replace the weakened aorta with a graft. Another option is a minimally invasive repair that threads a stent into the artery to close the torn vessel lining. 
    • The challenge is determining who might benefit.
    • That’s where AI might help, Cardiologist Eric Topol, who is also director of the Scripps Research Translational Institute, said, something scientists are exploring. 
    • “We are terribly weak at predicting who is going to progress from a widened aorta into a dissection, unfortunately. Where AI could make a huge contribution is to help pinpoint the people at risk because we waste a lot of imaging, putting people through all these MRIs and CTs and echoes on a frequent basis and only a very small proportion of those actually go ahead and have a dissection,” he told STAT. “Our ability to discriminate is very weak. And we need help.” 
  • Cardiovascular Business adds,
    • High cholesterol and other modifiable risk factors are responsible for a vast majority of deaths from ischemic heart disease (IHD) in the United States, according to a new analysis published in JAMA Cardiology. There has been progress in recent decades, researchers noted, but there is still a lot of work to do. 
    • “U.S. IHD mortality declined between 1980 and 2010 due to improved prevention and treatment,” wrote first author Catherine P. Benziger, MD, a cardiologist with Essentia Health, and colleagues. “Since 2010, this trend has slowed or reversed in most states due to plateaus in risk factor improvements, shifting risk factor exposures and fewer treatment advances.”
    • To learn more about the current state of this trend, Benziger et al. reviewed data from the Global Burden of Disease Study 2023. Overall, the group found that there were 473,000 IHD-related deaths in the United States in 2023. This is a significant improvement in many ways; IHD mortality was down 58.7% from 1990 to 2023 and down 19% from 2010 to 2023. However, the team’s research also identified a number of statistics that show just how much more work there is still to do when it comes to combatting these modifiable risks.
    • “One key takeaway from this analysis is the fact that modifiable risks were responsible for 88.7% of deaths from IHD. The encouraging news is that 127,000 fewer IHD deaths were linked to modifiable risk factors in 2023 than in 1990—and that comes at a time where the U.S. population has increased and grown older. Tobacco use, lead exposure and air pollution were all associated with a significantly lower number of IHD deaths in 2023, highlighting progress the country has made over the years. 
    • “The less encouraging news is the fact that some metabolic risks are on the rise, including high body mass index (BMI) and high fasting plasma glucose.”
    • “Current guidelines recommend screening at age 35 years and sooner if overweight or obesity is present, yet less than half of eligible U.S. adults report glucose testing, potentially due to issues including healthcare access, clinician guideline familiarity or patient care-seeking practices,” the authors wrote. “Glycemic and blood pressure control among U.S. patients with diabetes declined from the late 2000s onwards after a decade of progress in the late 1990s to early 2000s.”
       
  • The New York Times notes,
    • According to a New York Times analysis of provisional mortality data from the Centers for Disease Control and Prevention, the [illegal] drug death rate in Arizona last year overtook West Virginia’s for the first time since the proliferation of prescription painkillers in the late 1990s. Arizona and New Mexico now have the highest rate of drug deaths in the contiguous United States.
    • The rising drug deaths in the Southwest are in sharp contrast to the large-scale decline that has returned the U.S. drug death rate to its pre-Covid level. The reasons for this decline are still a matter of debate. 
  • CNN relates
    • “A yearly physical is the standard preventive measure for adults, but many Gen Z patients are forgoing regular doctor appointments.
    • “More than 1 in 4 young adults don’t have a primary care provider, according to a recent national survey by the Ohio State University Wexner Medical Center.
    • “For Gen Zers who do have a physician, most skip scheduled checkups or don’t schedule them: Only 47% of 18- to 29-year-olds said they have had an annual wellness visit in the past year, according to the survey findings, released June 29.” * * *
    • “An annual visit isn’t just about today’s health — it helps identify future risks, keeps preventive care on schedule and gives you a trusted clinician who knows your medical history and can help navigate health concerns, be they physical health or mental health concerns, as they arise,” said CNN wellness contributor Dr. Leana Wen, an emergency physician and clinical associate professor at George Washington University, in an email to CNN. Wen was not involved in the study.”
  • MedPage Today tells us,
    • “CDC survey data showed a 27% decline in healthcare-associated infections in U.S. hospitals from 2015 to 2023.
    • “The drop was driven primarily by declines in C. difficile infections, central catheter-associated bloodstream infections, and catheter-associated urinary tract infections.
    • “Meanwhile, the researchers said there was still room for improvement regarding surgical-site infections and infections not associated with devices or procedures.”
  • and
    • “Very high levels of plasma phosphorylated tau 217 (p-tau217), a marker of amyloid burden in the brain, predicted future risk of cognitive impairment among older adults who were initially unimpaired, a multicohort study suggested.
    • “Using different plasma assays and definitions of cognitive impairment across six cohorts, a “consistent pattern” emerged: those with very high p-tau217 had an estimated 38% risk of cognitive impairment over 5 years and an estimated 78% risk over 10 years, reported Rachel Buckley, PhD, of Mass General Brigham in Boston, at the Alzheimer’s Association International Conferenceopens in a new tab or window. The findings were published simultaneously in JAMAopens in a new tab or window.
    • “P-tau217 provided predictive information beyond amyloid PET, suggesting it may capture aspects of Alzheimer’s disease biology not explained by amyloid plaques alone, Buckley said.”
  • Reuters points out,
    • “Potential signs of frailty in older adults taking Eli Lilly’s GLP-1 obesity drug Zepbound may signal relatively high risks for adverse outcomes, according to a large study that underscores concerns about how best to monitor seniors as U.S. Medicare expands access to GLP-1 therapies.
    • “In general, frailty-associated conditions ‌such as malnutrition, dehydration and loss of muscle mass and strength developed only rarely and the results should not discourage appropriate use of Zepbound, known chemically as tirzepatide, ‌or Novo Nordisk’s GLP-1 drug Wegovy, also known as semaglutide, in older adults, the study’s researchers said. Instead, they encouraged closer follow-up of older patients taking the medicines.”
  • KFF Health News informs us,
    • “Thousands of Americans who undergo a common knee surgery might be making their problems worse rather than better.
    • “Researchers who followed patients for 10 years after they received either the actual procedure, arthroscopic knee surgery to trim degenerative cartilage tears, or merely “sham surgery” — a skin incision — for knee pain, found that the surgery provided little or no benefit and was, in fact, associated with accelerated osteoarthritis and higher rates of reoperation. That generally meant a total knee replacement.
    • “I don’t know how I would defend this procedure at all,” said one of the study’s authors, Teppo Järvinen, an orthopedist and the head of the Finnish Centre for Evidence-Based Orthopaedics. “What has been shown dramatically is that patients who have this procedure have more pain — they do worse. All the scores pointed in the same direction.”
    • “Järvinen said the Finnish study, published in April in the New England Journal of Medicine, was the first to show the surgery left many patients worse off. Though the study was small, the results were compelling, he said, because his team picked the patients “most likely to benefit.”
    • “The study does not apply to cartilage tears incurred from an acute pain-causing injury. It included subjects middle-aged or older who were experiencing knee pain and whose MRIs showed cartilage tears.”
  • Health Day adds,
    • “About 5 million Americans are thought to be using an opioid painkiller to ease their chronic pain. 
    • “A new study suggests that the safest route to reducing use of the powerful drugs is best left up to the patient.
    • “For patients, I think the data are reassuring that if opioids are tapered the right way, meaning a patient-centered approach, people can significantly reduce their opioid doses without having increased pain long term,” said study lead author Beth Darnall. She’s a professor of anesthesiology, perioperative and pain medicine at Stanford University in California.
    • “The study was published recently in the Annals of Internal Medicine and involved more than 500 adult patients.” * * *  
    • “The findings are in line with current U.S. Centers for Disease Control and Prevention (CDC) guidelines, which support a patient-driven approach to tapering off opioids for chronic pain.”
    • “The study does not apply to people who have developed an addiction to the powerful painkillers.”
  • Radiology Business lets us know,
    • “New PET imaging findings could help explain why some patients continue to experience lingering side effects from long COVID. 
    • “The analysis, which is published in eBioMedicine, indicates that individuals who have been diagnosed with the disease display significantly decreased dopamine neuron integrity on brain scans. Experts believe this could have something to do with why many continue to struggle with fatigue and lack of focus and motivation. 
    • “Our findings provide compelling evidence that long COVID involves the loss of dopamine-releasing neurons,” said study author Jeffrey Meyer, MD, PhD, senior scientist at the Brain Health Imaging Center in Toronto. “This kind of injury is well known to produce symptoms like lack of motivation and motor slowing, and may contribute to memory difficulties in other neurological conditions. Our results suggest a similar process is occurring in long COVID.” 
  • Genetic Engineering and Biotechnology News notes,
    • “An international team of scientists report that they have successfully mapped the cells and genes that regulate bone formation and loss and discovered the critical role that blood vessel cells play in bone health. By combining genomic sequencing with data from half a million individuals, the research team identified hundreds of previously unknown genes that govern bone health and revealed cells surrounding blood vessels as one of the drivers of bone repair.
    • “The study “Multiscale analysis and functional validation of the cellular and genetic determinants of skeletal disease” is published in Nature Genetics. The team says its findings fundamentally enhance our understanding of skeletal disease. It is hoped the discovery will enable the development of new therapies to rebuild lost bone, offering hope to almost half of all individuals over 50 living with rare and common skeletal conditions such as osteoporosis, osteoarthritis and osteogenesis imperfecta, as well as those with rare bone disorders and cancers that spread to bone.
    • “Most people don’t realize that bones are constantly changing; the human body replaces its skeleton every 10 years or so,” said Peter Croucher, PhD, professor at the Garvan Institute of Medical Research in Australia. “This is a hugely important process, but until now we’ve had a limited understanding of the cells and mechanisms that control this turnover of bone. “Most of the drugs now available focus only on halting bone disease, rather than rebuilding lost bone, which is really important for reversing damage.”
  • Per STAT News,
    • “In a new study published in Science Translational Medicine on Wednesday, researchers say they have uncovered how Epstein-Barr virus launches immune responses that lead to the inflammation and nervous system damage seen in people with multiple sclerosis. 
    • “It’s very nice now to be able to understand more about the underlying mechanisms of how EBV likely causes MS,” said lead author Kjetil Bjornevik, an assistant professor of epidemiology and nutrition at the Harvard T.H. Chan School of Public Health. The findings, researchers hope, could help with the development of EBV vaccines or antiviral medications that could prevent or manage MS symptoms without the major side effects of commonly used immunosuppressants. 
  • Per Fierce Pharma,
    • “Merck & Co.’s almighty Keytruda has become the first PD-1 inhibitor to show a benefit as a single agent for the front-line treatment of a subtype of endometrial cancer.
    • “Keytruda significantly improved progression-free survival over platinum-based chemotherapy in patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer. The patients had either received no systemic chemotherapy or experienced recurrence more than six months after completing prior adjuvant therapy.
    • “On its other dual primary endpoint, the Keynote-C93 trial also recorded an immature trend toward improvement in overall survival at the interim analysis. The trial is ongoing, with plans to evaluate the endpoint in the future. 
    • “The positive readout sets Keytruda up to be a new chemo-free option in first-line dMMR endometrial cancer, Brian Slomovitz, M.D., from Mount Sinai Medical Center and the study’s principal investigator, noted in a July 15 release. Merck now plans to share the results with regulatory authorities.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Elevance Health is shrinking its Medicaid business, worried about future profits in the beleaguered safety-net insurance program.
    • “The insurer is leaving Washington, D.C.’s Medicaid market this summer, and plans to exit additional Medicaid markets over the next 18 months, executives said during a call to discuss Elevance’s second quarter financial results Wednesday morning.
    • “It’s the latest example of insurers exiting underperforming markets to try to recoup margins after a difficult few years.” * * *
    • “Elevance largely delivered in the second quarter, outperforming Wall Street’s revenue and earnings expectations and boosting its 2026 earnings guidance on the strength of the results.
    • “Elevance brought in $1.5 billion in net income in the quarter, down more than 16% year over year, on operating revenue of $49.8 billion, up 1% year over year. Revenue rose thanks to Elevance hiking premiums in its health insurance plans and higher sales from Carelon.”
  • The Wall Street Journal relates,
    • “Johnson & Johnson raised its 2026 sales forecast to a range of $100.8 billion to $101.4 billion, up from its prior projection.
    • “The company increased its full-year adjusted earnings guidance to between $11.60 and $11.75 a share.
    • “Second-quarter sales rose 6.6% to $25.31 billion, driven by growth in both the pharmaceutical and medical device businesses.”
  • and
    • “Boehringer Ingelheim reported first-half net sales of 15.8 billion euros, up 16% when adjusted for currency changes.
    • “Sales of the company’s top-selling diabetes drug, Jardiance, rose to 5.7 billion euros from 4.3 billion euros in the year-earlier period.
    • “Boehringer Ingelheim is gearing up to file for U.S. approval of survodutide, its new obesity medicine.”
  • and
    • “Eli Lilly is losing to rival Novo Nordisk in the weight-loss pill market, capturing only about 11% of prescription volume for new pills.
    • “Doctors say patients prefer Novo Nordisk’s Wegovy pill over Lilly’s Foundayo because study data shows it leads to greater average weight loss.
    • “Lilly’s launch was also slowed by the time it took to secure reimbursement coverage from major pharmacy-benefit managers.”
  • Beckers Hospital Review tells us,
    • “Registered nurses in California earn the highest median pay in the country, while nurses in Alabama earn the least, according to data released May 15 by the Bureau of Labor Statistics.
    • [Included in the article] are the median hourly and annual wages for registered nurses in all 50 states and Washington, D.C., based on May 2025 data from the BLS Occupational Employment and Wage Statistics program, listed in descending order by annual wage. Nationally, registered nurses earned an annual median wage of $97,550, according to the BLS.
  • MedTech Dive offers an interview with “Jorge Garces, who joined Abbott to oversee scientific strategy for cancer diagnostics after it acquired Exact Sciences, discusses the future of the field, about Abbott’s cancer diagnostics vision: ‘There’s always a hunger to make these tests better.”
  • Fierce Healthcare informs us,
    • “Judi Health is continuing on its rebranding journey and announced on Wednesday that its pharmacy benefit management arm will now operate as Judi Rx.
    • “Previously known as Capital Rx, Judi’s PBM has operated on a transparent model for nearly a decade. Demand for new and alternative options in this market has grown as healthcare costs escalate, and Judi’s combined PBM and pharmacy benefit administrator clientele has grown to include more than 50 million lives across Medicare, Medicaid and commercial.
    • “In a June study backed by Judi, Employee Benefit News found that most organizations switching to a transparent PBM jumped ship from one of the legacy “Big Three” companies that have historically dominated this space.
    • “Alongside the Capital Rx rebrand, Judi announced that it will launch Judi Care, which represents its medical, dental and vision solutions, along with Judi Cloud, which allows for the licensure of its proprietary technology.”

Tuesday report

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

Simplicity is a virtue

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Monday report

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

Simplicity is a virtue.

From Washington, DC,

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

From the Food and Drug Administration front,

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

No Surprises Act news

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Weekend update

David Ermer–Agentic & Generative AI, Congress, Medicare, Obesity, U.S. Healthcare–

Simplicity is a virtue.

“National Simplicity Day on July 12 honors transcendentalist Henry David Thoreau, a man who advocated a life of simplicity. A man of many talents and skills, Thoreau was a supporter of living the simple life and encouraging others to do the same.”

Clarity Benefit Solutions offers the following pledge; “I pledge to make a conscious effort to simplify the administration, service, and user experience for benefits this year because I believe in the value and power of simplicity in a complicated world. Let’s let simplicity be our new normal.”

OPM should make good on this pledge by adopting the June 2026 recommendations that the AFHO trade association offered.

From Washington, DC,

  • Roll Call discusses this week’s anticipated events on Capitol Hill.
  • 24 Wall St reminds FEHB annuitants,
    • Skipping [Medicare] Part D for two years locks in a permanent 24% monthly surcharge worth roughly $113 annually on top of any plan premium.
    • The surcharge grows every year because it tracks the national base premium, which jumped 6% in 2026 alone, compounding lifetime costs into the thousands.
    • A 63-day gap without creditable coverage triggers the penalty even with no medications, making enrollment in the cheapest Part D plan the only sure defense.

From the U.S. public health and medical / Rx research front.

  • The Cleveland Clinic Newsletter tells us,
    • “As thousands of the world’s leading Alzheimer’s researchers, clinicians, and policymakers convene this week in London for the Alzheimer’s Association International Conference 2026, we have an opportunity to change the course of history for women’s health by focusing on women’s brains.
    • “For too long, women’s health has been compartmentalized into reproductive health, breast cancer, heart health and bone health. Missing from the conversation has been a focus on the organ that regulates every part of a woman’s body: the brain. That must end. Women’s health is brain health, and brain health is the core of women’s health.
    • “Women make up nearly two-thirds of those diagnosed with Alzheimer’s. Women are also far more likely to provide the unpaid care that keeps families and care systems from collapse. Yet women’s brains remain largely under-studied, under-discussed, and underprioritized in research, risk reduction and care.”
    • “The world can no longer afford to ignore [these issues].”
  • Onco Daily relates.
    • ‘Breast cancer incidence is increasing rapidly among Asian American, Native Hawaiian, and Pacific Islander women in the United States, with especially concerning trends in early-onset disease, distant-stage diagnosis, and aggressive molecular subtypes.
    • “A new population-based study published in JAMA Network Open examined invasive breast cancer incidence trends from 2000 to 2022 across disaggregated Asian American, Native Hawaiian, and Pacific Islander ethnic groups.
    • “The study included 148,608 Asian American, Native Hawaiian, and Pacific Islander females diagnosed with invasive breast cancer using National Cancer Institute SEER Program data from 14 US states.
    • “The findings challenge the older assumption that breast cancer incidence is uniformly lower among Asian American populations. They also show why grouping Asian American, Native Hawaiian, and Pacific Islander communities into one category can hide important differences in risk, stage, and subtype.”
  • The American Heart Association informs us,
    • “Gum disease bacteria may spur calcium buildup in the heart’s aortic valve, leading to a common and serious heart valve disease, according to preliminary, independent research presented at the American Heart Association’s Basic Cardiovascular Sciences Scientific Sessions 2026. The meeting, in Boston, July 13-16, 2026, is one of the largest meetings globally dedicated to fundamental and translational research in cardiovascular science.
    • “According to the American Heart Association, calcific aortic valve stenosis (CAVS) occurs when the aortic valve thickens and calcifies, restricting blood flow from the heart to the rest of the body. In early stages, there may be no symptoms; however, as the condition progresses, it can cause fatigue, chest pain, shortness of breath, fainting, heart failure and sometimes premature death. Standard treatment for severe CAVS is valve replacement surgery.
    • “This study identifies a potential biological pathway linking chronic oral gum disease and infection to calcific aortic valve stenosis.” * * *
    • “The American Heart Association’s Healthy Smiles, Healthy Hearts™ initiative provides dental care teams with professional education highlighting the connection between oral health and heart health, a standard blood pressure screening and referral guide for patients in dental settings, and educational materials for patients to help improve both their oral and heart health.
    • “The study has limitations because its findings have not been confirmed in people. The researchers have started a clinical study to further evaluate the link between gum disease and CAVS.”
  • U.S. Medicine points out,
    • “A top priority for researchers who study aging is how to identify and treat frailty, even though there are no established therapeutic interventions for the condition.
    • “That’s why a new study of U.S. veterans is considered so important. It found that initiation of statins was associated with a significantly lower risk of incident frailty or death among the older participants, including those who were pre-frail at baseline.
    • “There are currently no approved medications specifically to prevent frailty,” explained lead author Saadia Qazi, DO, MPH, MSc, a cardiologist at the VA Boston Healthcare System and in the Division of Aging in Mass General Brigham’s Department of Medicine. “Our findings suggest that statins may offer an important opportunity to reduce the risk of frailty and help people preserve their health and independence as they age.”

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

  • Out of the Beltway informs us, “The Economist surveys recent research and concludes, “An ageing society might not cost too much.”
    • “Spending on health care depends on how much it costs to provide and how much treatment is needed. Generally, the former has increased over time. Economists attribute this to Baumol’s cost disease, diagnosed by William Baumol, an American economist. Technologically intensive sectors (think of manufacturing or software development) get more productive. Labour-intensive service sectors do not. A doctor’s consultation takes roughly as long as it did a century ago. Yet physicians’ pay must match increases in faster-growing skilled industries, or all the doctors will go to work in tech. (Baumol pointed out that a string quartet still took 45 minutes to perform a Schubert work,but was paid vastly more than when the composer was alive.) […]
    • “Two new papers from the National Bureau of Economic Research, a repository of economic thought, suggest that the vision of health care gobbling up tax revenues may not come to pass. In the first, David Cutler and Lev Klarnet, both of Harvard University, observe that in 2024 America spent $1trn less on health care than official forecasts from 2010. The second is by Liran Einav, of Stanford University, and Amy Finkelstein, of the Massachusetts Institute of Technology (MIT). Using a survey of users of Medicare, America’s system of health insurance for the old, they find that, whereas expected lifetime spending on Social Security (ie, pensions) rose by 14% between 1993 and 2017, the expected cost of Medicare increased by only 6%. That is partly because elderly Americans have been collecting their pensions for longer but spending less time seriously ill.
    • “The papers point to improvements on both sides of the equation. Start with the cost of providing health care in hospitals. Messrs Cutler and Klarnet point out that, between 2000 and 2010, it consistently rose by around 2.3 percentage points above inflation—but that later something changed. Between 2011 and 2024 hospital costs rose by only 0.5 percentage points more than overall prices. Technology has played a role. Technological improvements in health care come in two types: some are adopted because economies get richer and can afford to treat new things; others make it cheaper to provide the same outcomes. For much of the past century, the first type dominated the second. Now, it seems the second type has taken over. Baumol’s cost disease turned out to be curable.”
  • McKinsey and Co. considers that “The consumer is changing fast. Four trends—the tech-driven path to purchase, the health revolution, the experience economy, and the resourceful consumer—will redefine the sector. Will brands keep up?”
  • MedCity News notes that “Healthcare and AI are in Need of Relationship Counseling.”
    • “Performing well in controlled settings is only part of the picture, the harder question is whether AI is being integrated into clinical workflows in ways that keep responsibility, authority, and accountability properly aligned.”
  • The Wall Street Journal reports.
    • “Eating-disorder therapists say patients are increasingly using chatbots for diet and exercise advice, sometimes challenging professional guidance.
    • “Therapists warn that chatbot advice delivered without clinical context can be dangerous and delay vital treatment for eating disorders.
    • “AI companies say they are working to improve how their models recognize and respond to signs of disordered eating.’

Notable Death

  • The Frederick (MD) News Post reports,
    • “Martha Lillard had just turned 5 when she was diagnosed with polio and depended on an iron lung to live. She died June 26 in Oklahoma, the last U.S. polio patient who used the machine, her sister said. She was 78.
    • “They told her she wasn’t supposed to live past 20 years old,” Lillard’s younger sister, Cindy McVey, told The Associated Press on Friday. “She had the enthusiasm and the drive to continue living and make the best of her life.” * * *
    • “McVey described her sister as artistic and creative. She wrote poems and composed songs. She wrote her own obituary, which is now posted online by a funeral home. She described being a Humane Society volunteer. “She was an avid Beagle lover and assisted in animal rescue as a cross poster on Facebook,” Lillard wrote.”
  • RIP


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.”

Tuesday report

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

Simplicity is a virtue

From Washington, DC,

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

From the Food and Drug Administration front

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

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.”