Midweek update

Rx coverage

Midweek update

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

From Washington, DC,

  • Roll Call reports,
    • “Senate Republicans say they are working on a bipartisan health package to lower drug and health insurance costs, a development that’s news to some Democrats who remain skeptical that their GOP colleagues will work with them.
    • “Sen. Bill Cassidy, R-La., is leading the talks, with a particular focus on more transparency from pharmacy benefit managers, so-called upcoding practices in Medicare Advantage and other health items.
    • “A group of Republican senators, including Lisa Murkowski of Alaska, are pushing to extend expiring health insurance subsidies for people who buy their own insurance on the marketplaces.
    • “Republicans are tight-lipped about the package, which is in the very early stages, said Sen. Michael D. Crapo, R-Idaho, who chairs the Senate Finance Committee.
    • “We’re going to have PBM legislation that hopefully will remain bipartisan, and there have been a number of other initiatives. I’m not going to start singling things out,” Crapo said Tuesday. “We are discussing everything that people want to look at as issues,” including Medicare Advantage, a private alternative to traditional Medicare, adding that he was disappointed certain changes weren’t addressed in the reconciliation package.”
  • Healthcare Dive offers more details on Tuesday’s Senate hearing about the Medicare Advantage program.
  • Mercer tells us,
    • “The Affordable Care Act (ACA) benchmark for determining the affordability of employer-sponsored health coverage will increase significantly for the 2026 plan year according to IRS Rev. Proc. 2025-25 — to 9.96% of an employee’s household income up from the 2025 plan-year level of 9.02%. This affordability percentage can affect individuals’ eligibility for federally subsidized coverage from a public exchange, as well as employers’ potential liability for shared-responsibility (or “play or pay”) assessments.” * * *
    • “Employers should review the required employee contribution for 2026 coverage if they plan to meet the ACA’s affordability limit under the applicable safe harbor. For the many plans using the FPL affordability safe harbor, the considerations differ for calendar- and non-calendar-year plans.”
  • Modern Health lets us know,
    • “Medicare may soon test a plan to equalize reimbursements for outpatient services regardless of where the care is provided.
    • “This foray into so-called site-neutral payment would begin next year and focus on physician-administered medications such as chemotherapy drugs. Hospitals would get paid less than they are now for providing those services.
    • “The plan, contained in the Hospital Outpatient Prospective Payment System proposed rule for 2026 that the Centers for Medicare and Medicaid Services issued last Tuesday, reflects growing interest in setting uniform Medicare rates for services across settings.”
  • The American Hospital Association New informs us,
    • The White House July 23 released an action plan with a series of more than 90 policy recommendations to expand the use of artificial intelligence. The plan follows a directive from the administration’s Jan. 23 executive order, “Removing Barriers to American Leadership in Artificial Intelligence.” The policy recommendations are aligned across three pillars — accelerating innovation, building American AI infrastructure, and leading in international diplomacy and security. The action plan recommends the launch of sector-specific efforts, including health care, to convene stakeholders to accelerate the development and adoption of national standards for AI systems. It also calls for testing AI system pilots in real-world settings across health care and other sectors through regulatory sandboxes and AI centers of excellence.
    • Other policy recommendations include removing onerous federal regulations that hinder AI development and deployment; expediting permits for building data centers and semiconductor facilities; expanding AI literacy and skills for education and workforce training; and bolstering critical infrastructure cybersecurity pertaining to AI.
  • and
    • “The Department of Health and Human Services July 23 announced it is recommending the removal of thimerosal from all U.S. flu vaccines. The announcement follows a recommendation last month by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The FDA posted a webpage yesterday allowing drug companies to indicate their interest in participating in a pilot voucher program that aims to cut product review times down to just one to two months. The agency will be choosing five companies in the first round.
    • “The FDA announced last month that it would launch this program to reward companies whose actions align with certain policy priorities, including addressing unmet public health needs, beefing up domestic production of drugs, and delivering more innovative cures.
    • “The webpage states that another “program priority” is increasing affordability, such as lowering drug prices in line with President Trump’s most favored nation policy.
    • “Critics say the voucher program raises concerns that the FDA is injecting politics into drug review decisions that should be centered around science, and that one to two months is not a sufficient amount of time to review new drugs.”
  • Per BioPharma Dive,
    • “Roche is pausing sales of the Duchenne gene therapy Elevidys in some countries outside the U.S. after partner Sarepta Therapeutics agreed Monday to a Food and Drug Administration request to do the same in the U.S.
    • “Roche said Wednesday it is temporarily and voluntarily halting shipments of the treatment in countries that reference the FDA’s approval of Elevidys in their local decision. The Swiss pharmaceutical company markets the gene therapy outside the U.S. under a 2019 alliance with Sarepta and will continue to ship Elevidys in countries that don’t rely on FDA decisions.
    • “The FDA asked Sarepta to stop shipping Elevidys following the deaths from acute liver failure of two teenagers treated with it earlier this year. Both Sarepta and Roche maintain the benefit-risk balance to treatment remains positive in younger patients who can still walk.”
  • Fierce Pharma points out,
    • “Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company’s multiple myeloma ambitions with a glimmer of hope.
    • “Following last week’s negative feedback from the FDA’s Oncologic Drugs Advisory Committee (ODAC), the agency was scheduled to make the final call on the drug’s use in patients with multiple myeloma who have received at least one prior line of therapy by July 23. 
    • “Now, the FDA has pushed back its decision date to Oct. 23, tacking on extra time to “review additional information provided in support of the application,” GSK announced Wednesday.”
  • The AHA News notes,
    • “The Food and Drug Administration July 22 released an early alert for Novum IQ large volume infusion pumps by Baxter. The company stated that the pump has potential for under infusion when transitioning to a higher flow rate. The FDA said Baxter has reported 79 serious injuries and two deaths associated with the issue as of June 27.”

From the judicial front,

  • Federal News Network reports,
    • “Details of the imminent reductions in force and staffing reorganizations planned across government will remain under wraps after an appeals court blocked a judge’s order for a list of those plans to be released.
    • “The Ninth Circuit Court of Appeals granted the Trump administration’s request for an emergency stay on U.S. District Court Judge Susan Illston’s order for the government’s lawyers turn over the dozens of RIF plans they said are ready for implementation.
    • “The appeals court’s decision means agencies can still move forward with any planned RIFs and staffing reorganizations without needing to divulge that information either to the court or to the public, at least for the time being.”
  • Per Bloomberg Law,
    • “Neurological Surgery Practice of Long Island, PLLC sued the Health and Human Services, Labor, and Treasury departments in April 2023, alleging the agencies failed to establish and enforce procedures to resolve surprise billing disputes as required by Congress under the No Surprises Act. The law requires insurers and doctors to resolve unexpected out-of-network bills through arbitration, rather than billing the patient.”
    • The district court ruled against the provider, and today the U.S. Court of Appeals for the Second Circuit affirmed (Dropbox link) the district court’s ruling (No. 24-1884).

From the public health and medical research front,

  • CBS News reports,
    • “Rich’s Ice Cream is recalling 110,292 cases of frozen dessert products across 23 states due to potential listeria contamination, which can lead to serious illness.
    • “The recall, which was first initiated in June, was recently updated to a Class II threat, meaning the product “may cause temporary or medically reversible adverse health consequences,” the U.S. Food and Drug Administration says.
    • “According to federal health officials, the products were distributed to Alabama, Arizona, California, Florida, Georgia, Illinois, Iowa, Louisiana, Massachusetts, Montana, Nebraska, Nevada, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin. They were also sold in Nassau, Bahamas.” * * *
    • “Customers can visit the Rich’s Ice Cream website for more information on product labels.”
  • The University of Minnesota informs us,
    • “Amid ongoing record post-elimination measles activity in the United States, four states have reported more measles cases, including Colorado, Iowa, New Mexico, and Wyoming.
    • “Meanwhile, in its weekly update, the US Centers for Disease Control and Prevention (CDC) added 10 more cases to the national total, which has now reached 1,319 cases.
    • “In early July, the United States passed its previous post-elimination record of measles cases, and though cases in the West Texas outbreak have declined steadily, smaller outbreaks and travel-linked cases continue to push the nation’s total higher. The surge in US measles activity is part of a global rise in cases made worse by dropping childhood immunization rates.
    • “The CDC said the number of affected states remained at 40, with the number of outbreaks holding at 29. So far, 87% of the nation’s cases are connected to outbreaks and 92% of affected patients are unvaccinated or have unknown vaccination status. Children ages 5 to 19 years old are the most affected age group, followed closely by adults ages 20 and older.”
  • Per STAT News,
    • “The H5N1 bird flu virus has historically extracted a heavy toll when it infects humans, with nearly half of confirmed cases ending in death over the past three decades. But of the 70 cases reported in the United States over the past 18 months, only a single death occurred, leaving experts puzzled at how to explain the phenomenon.
    • “A new study published Wednesday adds weight to an argument that the immunity people have developed to the virus that caused the most recent flu pandemic, an H1N1 virus that emerged in 2009, has induced some cross-protection that may be making it harder for H5N1 to infect people, and mitigating the severity of the ensuing disease when such infections occur.
    • “The paper, published in the journal Science Translational Medicine, reports on a number of studies done in ferrets, the closest animal model for what happens when humans are infected with influenza. It showed that while H5N1 is lethal to ferrets with no immunity to influenza, animals that have previously been infected with influenza A — either H3N2 or H1N1 — appear to have some protection when they are later exposed to the bird flu virus. The protection is particularly strong with H1N1.
    • “Seema Lakdawala, one of the authors of the study, said the findings provide hope that, should H5N1 — long considered a major pandemic threat — acquire the ability to spread easily to and among humans, the resulting pandemic might not be as disastrous as people have feared.”
  • MedPage Today tells us,
    • “A meta-analysis pooled data on dose-response associations between daily steps and a broad range of health outcomes.
    • “Increasing daily step counts above 2,000 was associated with risk reductions in mortality and cardiovascular, cancer, and other outcomes.
    • “A goal of 5,000 to 7,000 steps per day [not 10,000 steps] was deemed appropriate for achieving good health.”
  • HCPLive points out,
    • “A study found no significant differences in IBS symptom severity between gluten, wheat, and sham challenges, questioning the role of these ingredients as triggers.
    • “Despite findings, many patients continued a gluten-free diet, indicating psychological factors may influence symptom perception and dietary choices.”
  • HHS, FDA and USDA discuss their approach to ultra-processed food here.

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Molina Healthcare is seeing sustained pressure as the insurer released its second quarter financial results.
    • “For the full year, the company anticipates a floor of $16.90 per diluted share and adjusted earnings to be at least $19.00 per diluted share. Earlier this month, the insurer warned medical cost pressures would affect adjusted earnings, lowering its target to $21.50 to $22.50 per share.
    • “Molina’s stock has dipped about 4% in after-hours trading.
    • “The current earnings pressure we are experiencing results from what we believe to be a temporary dislocation between premium rates and medical cost trend which has recently accelerated.,” said CEO and President Joseph Zubretsky in a statement. “We are still performing near our long-term target ranges, and nothing has changed our outlook for the long-term performance of the business.”
    • “Adjusted net income for the quarter is $5.48 per diluted share, similar to its preview from early July, for a decrease of 6% year-over-year.”
  • MedCity New tells us,
    • “Aeroflow Health, a health tech company, has teamed up with Cigna to provide virtual nutrition services to its members nationally, the company announced (Opens in a new window)on Tuesday.
    • “Asheville, North Carolina-based Aeroflow Health was founded in 2001 and offers an array of medical devices covered by insurance. The company has four lines: Aeroflow Breastpumps, Aeroflow Diabetes, Aeroflow Sleep and Aeroflow Urology. In addition to medical devices, it provides education and consultations. The company has partnerships with more than 1,000 insurance plans.
    • “Through the partnership with Cigna, Aeroflow Health will serve Cigna members who would “most benefit from nutrition interventions,” such as new mothers, those with diabetes or those with a chronic disease, according to the announcement. These patients will have access to registered dietitians, who can create personalized meal plans and provide tips to support their goals, such as boosting breast milk production, losing weight, reducing cholesterol or lowering the risk of heart disease.”
  • Healthcare Dive relates,
    • “Tenet Healthcare raised its 2025 financial guidance on Tuesday after releasing second-quarter earnings that showed year-over-year growth in revenue and adjusted earnings before interest, taxes, depreciation and amortization.
    • “The hospital operator now expects between $20.95 billion and $21.25 billion in revenue for 2025 on net income of $1.3 billion to $1.4 billion. Previously, Tenet projected $20.6 billion to $21 billion in revenue and $1.1 billion to $1.2 billion in income.
    • “Still, Tenet declined to answer questions on a Tuesday morning call with investors about the future financial impacts from the recently enacted “One Big Beautiful Bill” and potentially expiring Affordable Care Act exchange premium tax credits. Tenet’s stock declined about 15% by market close on Tuesday.”
  • Per Fierce Healthcare,
    • “Community Health Systems (CHS) shared word that it beat Q2 consensus estimates for both revenue and earnings, as well as news that CEO Tim Hingtgen will retire later this year.
    • “The public for-profit logged net operating revenues of $3.13 billion for the quarter, above the $3.02 billion estimate. That’s a 0.2% dip from the second quarter of 2024 though same-store net operating revenues rose 6.5%, reflecting divestitures the company underwent during the past year.
    • “The revenues outline a 7.4% year-over-year decline in admissions and an 8.3% decline in year-over-year admissions. However, same-store admissions rose by 0.3% while same-store adjusted admission fell by 0.7%.
    • “Net income attributable to stockholders was $282 million ($2.09 per share), as opposed to the $13 million net loss (-$0.10 per share) a year prior. Those decrease to a $0.05 net loss per share for Q2 2025 and $-0.17 net loss per share for Q2 2024 when excluding adjusting items related to early extinguishment of debt and asset sales.”
  • Beckers Hospital Review lets us know how health systems are staying ahead of drug shortages, and
    • “Pfizer and Bristol Myers Squibb have launched a direct-to-patient program offering their blood thinner Eliquis at a 40% discount for cash-paying patients. 
    • “The list price for Eliquis (apixaban) is $606 for a 30-day supply, but through the new program, the discounted price is approximately $242. More than 15 million Americans have prescriptions for Eliquis, according to a July 17 news release from Bristol Myers Squibb.” 
  • Optum, writing in LinkedIn, discusses the connection between AI and Rx benefits.
  • Per a news release, the Institute for Clinical and Economic Review (ICER) has issued its Draft Evidence Report on Treatment for Non-Cystic Fibrosis Bronchiectasis. The public comment period is now open until August 19, 2025; Requests to make oral comment during public meeting also are being accepted.
  • Per BioPharma Dive,
    • “A new biotechnology company debuted Wednesday with a hefty bankroll and an immunotherapy approach it claims has the potential to treat an array of tough-to-reach solid tumors.
    • “Called Dispatch Bio, the startup was formed in 2022 through a collaboration between Arch Venture Partners and the Parker Institute for Cancer Immunotherapy and built around technologies from scientific labs in Pennsylvania and California. It has since raised $216 million and developed a lead program that’s expected to enter clinical testing next year.
    • “Dispatch aims to deliver to cancer cells a sequence for a unique type of protein flag, known as an antigen, that it says can draw in specially engineered immune cells it plans to administer afterwards. The company believes its approach could yield a “universal” solid tumor treatment.”
  • and
    • “Abivax’s shares soared more than 500% on Wednesday after the company released positive Phase 3 results for its experimental ulcerative colitis medicine.
    • “The Paris-based biotech conducted two studies of its drug, obefazimod, in patients with moderately to severely active ulcerative colitis who didn’t receive enough relief from prior therapies. The 50 milligram dose of the medicine achieved a pooled 16.4% placebo-adjusted clinical remission rate at week 8, better than what was reported in Phase 2 testing, Abivax said late Tuesday.
    • “Researchers are now conducting a 44-week maintenance trial that should yield topline results in the second quarter of next year. If those results are also positive, Abivax plans to submit applications to U.S. and European regulators in the second half of 2026.”

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC

  • Per a Congressional press release,
    • “Congressman Raja Krishnamoorthi (D-IL) and Congresswoman Diana Harshbarger (R-TN) introduced [on July 15, 2025] the Fair Pharmacies for Federal Employees Act, legislation to protect federal employees and retirees from anti-competitive practices by pharmacy benefit managers (PBMs) and insurers. Under the bill, the Office of Personnel Management (OPM) is prohibited from contracting with entities in the Federal Employee Health Benefits Program (FEHBP) that both manage prescription drug benefits and own or control a pharmacy. The federal government administers and oversees the largest employer-based health care system in the country. By implementing comprehensive reform at the federal level, a proven model will be created that will lower health care costs across the board beyond the federal workforce and reach millions of Americans impacted by anti-competitive practices used by PBMs.” * * *
    • “The full text of the legislation is available here.”
  • This proposal would be very disruptive to the FEHB Program’s prescription drug benefits. Indeed, the FEHB Program’s prescription drug benefits would benefit from deregulation. 
  • Federal News Network reports,
    • “Employee departures at the Office of Personnel Management are contributing to the agency’s ongoing challenges with addressing fraud risks in the Federal Employees Health Benefits program.
    • “A new report from the Government Accountability Office dug into whether OPM had considered assessing various factors that create risks for fraud in the government’s health insurance program for federal employees. But partially due to recent staffing vacancies, OPM was unable to provide a clear answer.
    • “OPM officials “could not explain or provide documentation as to whether these inherent risks were considered as part of the assessment process, and why the resulting fraud risk profile does not address these risks,” GAO wrote on Thursday.
    • “Amid the overhauls that have taken place in OPM’s internal workforce over the last several months, agency officials who were previously responsible for conducting fraud risk assessments have left their jobs, according to GAO’s report.”
  • FEHB carriers, which hold the insurance risk, bear the laboring oar on fraud risk assessments. Carriers work closely with the Office of Inspector General.
  • STAT News informs us,
    • “The Trump administration is opening the floodgates for more surgeries to be done in outpatient facilities like ambulatory surgery centers, proposing a Medicare policy that could accelerate the shift away from hospital-based care. 
    • “The administration is aiming to scrap Medicare’s list of 1,700 procedures that the program will only pay for in inpatient settings. Medicare officials unveiled their decision to eliminate the so-called inpatient only list in a proposed rule on Tuesday, reprising an effort from the first Trump administration. 
    • “The agency had already removed common surgeries like hip and knee replacements from the list in recent years, but it said that getting rid of it entirely will give patients more choices and allow doctors to use their professional judgment to decide where procedures should take place. 
    • “Doctors, for their part, raised a number of concerns with the change, noting that it could jeopardize insurance coverage for inpatient surgeries and raise out-of-pocket costs for patients. But far and away their main issue with eliminating the list was the potential to endanger patients if the shift happens too quickly and with the wrong patients.
    • “I wouldn’t say that most doctors are going to be cowboys about it, but they may be working in health systems where they say, ‘Hey we want to get x-percent of these procedures done in the outpatient setting,’” said Andrew Ibrahim, an associate professor of surgery at the University of Michigan. “There may be nudges from their health system or the way their practice is set up.” 
  • The Washington Post reports,
    • “Partnerships between telehealth companies and pharmaceutical giants Pfizer and Eli Lilly raise concerns about conflicts of interest and inappropriate prescribing, according to a Senate investigation released Thursday.
    • “The report by offices of several Democratic senators said the arrangements appear intended to steer patients to medications manufactured by those companies, which maintain websites touting drugs and providing links directing them to doctors who can prescribe them.
    • “Such partnerships undermine the independent medical judgment of doctors, who may default to prescribing medications first instead of exploring other options and potentially “glossing over the comprehensive evaluation necessary for high-quality patient care,” concluded the report from the offices of Sens. Dick Durbin (D-Illinois), Bernie Sanders (I-Vermont), Elizabeth Warren (D-Massachusetts) and Peter Welch (D-Vermont).
    • “In statements, Eli Lilly and Pfizer said their online portals are meant to make it easier for patients to navigate health care and they do not pressure clinicians to prescribe their drugs.”
  • Per a CMS press release,
    • “The Centers for Medicare & Medicaid Services (CMS) continue to crush fraud, waste, and abuse in America’s healthcare programs by stopping duplicative enrollment in government health programs, with the potential to save taxpayers approximately $14 billion annually.
    • “A recent analysis of 2024 enrollment data identified 2.8 million Americans either enrolled in Medicaid or the Children’s Health Insurance Program (CHIP) in multiple states or simultaneously enrolled in both Medicaid/CHIP and a subsidized Affordable Care Act (ACA) Exchange plan. 
    • “CMS is taking action to ensure individuals are only enrolled in one program and to stop the federal government from paying multiple times for these individuals to receive health coverage. In addition, as a result of the One Big Beautiful Bill Act, CMS now has new tools to prevent the federal government from paying twice for the same person’s care—saving billions and restoring integrity to the system.”
  • The American Hospital Association News adds,
    • “The Centers for Medicare & Medicaid Services July 17 issued two letters to states regarding policies on continuous eligibility and workforce initiatives. The agency said it does not anticipate approving new or extending existing section 1115 demonstration authorities, which expand continuous eligibility. Additionally, CMS said it does not anticipate approving new or extending existing Medicaid-funded workforce initiatives for training or employment-related activities.”
  • Govexec tells us,
    • “In his first public memo since his Senate confirmation last week, Office of Personnel Management Director Scott Kupor wrote that due to the 2023 Supreme Court case Groff v. DeJoy, which held that employers must demonstrate “substantial increased costs” if they deny an employee’s religious accommodation request, federal agencies should work to honor such requests from their employees.
    • “Agencies are encouraged to adopt a generous approach to approving religious accommodations, prioritizing employee needs while maintaining operational efficiency,” Kupor wrote. “Further, federal agencies must adhere to the requirements of Title VII [of the 1964 Civil Rights Act] and the Groff clarification of the ‘undue hardship’ standard when addressing religious accommodation requests.”
    • “Agencies may use a number of workplace flexibilities to address an employee’s religious accommodation request, including telework, compensatory time off, flexible and maxiflex work schedule, and both paid and unpaid leave. Telework in particular can be useful to accommodate observing—or preparing to observe—a religious holiday or sabbath observance, to engage in religious fasting or other time-specific prayer observances.”
  • Tammy Flanagan, writing in Govexec, lets us know that “OPM’s digital retirement application is live. What that means for feds planning to retire. The new electronic retirement system promises a faster, more accurate process, but some users are still adjusting to the change.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “In a surprise, advisers to the Food and Drug Administration on Thursday voted that the risks tied to a blood cancer drug from GSK outweighed the benefits it had demonstrated in trials, as concerns about sometimes serious eye-related side effects and questions about the dose the company selected dominated a hearing.
    • “The FDA is set to decide whether to approve the drug, called Blenrep, by as soon as next week. The agency often follows its advisers’ recommendations but does not have to.”
  • The AHA News relates,
    • “The Food and Drug Administration July 15 announced a recall by Sandoz on certain lots of cefazolin, due to the lots being mislabeled as penicillin G potassium. The FDA said the inadvertent administration of cefazolin following a recommended dosage of penicillin G potassium could pose serious and potentially life-threatening health consequences. Sandoz has not received any reports of adverse events or injuries related to the mislabeling but has received a complaint of the mislabeled product being administered to a patient.” 
  • Per MedTech Dive,
    • “Integra Lifesciences has recalled cranial drills over a defect linked to 10 injuries, the Food and Drug Administration said Wednesday.
    • “The company has asked customers to return Codman cranial perforators because they may break apart during use, causing the device to become lodged in the patient’s skull or injure the brain.
    • “Integra began the recall months after the FDA sent a warning letter to three facilities that make products including cranial perforators.” 

From the judicial front,

  • Fierce Healthcare reports,
    • “A new lawsuit brought by 20 Democratic attorneys general says a recent final rule by the Centers for Medicare & Medicaid Services (CMS) will make it unfairly difficult to obtain health insurance through the Affordable Care Act (ACA).
    • “The lawsuit mirrors a challenge by three cities and liberal advocacy groups earlier this month. Plaintiffs in both cases say the regulation will cause up to 1.8 million people to lose coverage, starting in 2026. Many more will see premiums increase and out-of-pocket costs soar.
    • “Thursday’s suit (PDF) also takes issue with a provision in the rule, finalized in June, barring federal funds toward gender-affirming care services as an essential health benefit under the ACA.
    • “The states hope to delay the rule from taking effect in August.”

From the public health and medical research front,

  • The AP reports,
    • “Health officials in Illinois and North Dakota say their states’ measles outbreaks are over, pointing to a continuing slowdown of measles spread in the U.S. during vaccine-preventable disease’s worst year since 1991.
    • “Wednesday’s national case count stood at 1,309 — 21 new cases in a week, according to the U.S. Centers for Disease Control and Prevention. Last week, the U.S. passed the total count for 2019, when the country almost lost its status of having eliminated measles. 
    • “A vast majority of this year’s cases are from Texas, where a major outbreak raged through the late winter and spring. Other states with active outbreaks — which the CDC defines as three or more related cases — include Arizona, Colorado, Georgia, Iowa, Kansas, Kentucky, Michigan, Missouri, Montana, New Mexico, Oklahoma and Utah. 
    • “There have been three deaths in the U.S. this year, and all were unvaccinated: two elementary school-aged children in West Texas and an adult in New Mexico.”
  • The Washington Post relates, “Flesh-eating bacteria has killed 4 in Florida. Here’s what to know. Four people in Florida have died this year after contracting Vibrio vulnificus. Though rare, infections can require intensive care or limb amputation.”
  • The International Foundation of Employee Benefit Plans offers detailed advice on how to improve GI health in the workforce.
  • The National Science Foundation points out “AI that delivers smarter glucose predictions without compromising privacy.”
  • Per MedCity News,
    • “Over the past decade, employer-sponsored healthcare has undergone a significant transformation. Mental health solutions are finally mainstream. Fertility benefits are expanding. Women’s health has received overdue attention and innovation. Yet amid this evolution, one critical area remains largely ignored: men’s health.
    • “More than 88% of working-age men have unmet preventive, reproductive, and hormonal health needs. Despite making up half the workforce, men are falling through the cracks of today’s benefits strategies, often suffering in silence, delaying care, and showing up at the doctor’s only when it’s too late.
    • “For employers, this is more than a missed opportunity. It’s a growing liability financially, operationally, and culturally. Men’s health must be redefined not just as a clinical issue, but as a strategic business lever.”
  • Per STAT News,
    • “After a decade-long rise in suicide rates among young Americans — and with depression diagnoses soaring in this age group during the pandemic — the U.S. surgeon general issued a report in 2021 warning about the “devastating” state of youth mental health. The American Psychological Association declared it a “crisis.”It was part of a prolonged advocacy campaign to raise awareness about the problem and possible solutions, and finally, in 2022 and 2023, there were signs of success: Suicide rates for teens and young adults began to fall.
    • “Meanwhile, another demographic has gone largely overlooked. The people most at risk from suicide aren’t those in crisis in adolescence or midlife, but men age 75 and older. Some 38.2 deaths per 100,000 among men age 75 to 84 are by suicide, which increases to 55.7 among those over 85, according to data from CDC — more than 16 times the suicide rate for women in the same age group. Researchers are calling for a public health effort, much like the one to treat youth mental health, to help address suicide in older men.”
  • and
    • “Expert guidelines that clinicians across the country use to assess the risk of preeclampsia in pregnant women may be ineffective.
    • “The recommendations designed by the U.S. Preventive Services Task Force do not accurately predict risk of developing the condition and lead to nonspecific treatment guidance for the majority of patients, researchers found in a study published Thursday in JAMA Network Open. The findings have implications for reforming risk guidelines and increasing personalized care.
    • “This is a valuable, descriptive study,” Molly McAdow, a maternal-fetal medicine specialist at Yale New Haven Hospital, said. “There is certainly an opportunity for us to do better with a more stringent screening test.”
  • Per Health Day,
    • “Doctors might be overlooking a common cause of high blood pressure.
    • “New guidelines recommend screening for primary aldosteronism.
    • “Too much of the hormone aldosterone causes low potassium and high sodium, leading to high blood pressure.”
  • and
    • “Bedtime dosing with antihypertensive medication yields better nocturnal blood pressure control and improved circadian rhythm, according to a study published online July 9 in JAMA Network Open.”
  • Beckers Hospital Review relates,
    • “Pfizer is warning physicians that it expects a new shortage of Bicillin L-A, a long-acting penicillin injection that is currently the single recommended treatment for syphilis during pregnancy, CNN reported July 16. 
    • “The drugmaker’s alert follows a July 10 recall of certain lots found to contain floating particles, which Pfizer traced to faulty stoppers from an outside vendor. The company said no adverse reactions have yet been reported. 
    • “We have identified the root cause to be associated with stoppers supplied from an external vendor and are implementing the appropriate corrective and preventative actions,” the company said in a statement to the news outlet. “We fully recognize the importance of this medicine for patients and are working as quickly as possible to resolve the matter.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Elevance on Thursday became the fourth major health insurer to lower or scrap its profit forecast, and executives warned things are going to get worse for the embattled sector before they get better. 
    • “Like its peers, Elevance said its members are getting a lot more care than the company had projected. For Elevance, the uptick is more pronounced in its Affordable Care Act business, but it’s also happening in Medicaid. The company lowered its full-year profit outlook by 13% to account for the higher costs, which are also baked into the plans it’ll sell in 2026. 
    • “We recognize that revising guidance for the second consecutive year is disappointing,” Gail Boudreaux, Elevance’s CEO, said on the company’s earnings call. “We remain committed to transparency and strong execution as we continue to navigate unprecedented cost trends affecting multiple lines of business.” 
  • Modern Healthcare lets us know,
    • “Group healthcare costs are expected to increase by 8.5% in 2026.
    • “PricewaterhouseCoopers’ Health Research Institute based its forecast published Thursday on policy changes, expensive medications including glucagon-like peptide agonists, higher rates of behavioral health claims and increased use of artificial intelligence, among other factors.
    • “For PwC’s annual report, researchers spoke with actuaries at 24 different health insurers covering 125 million employer-sponsored members and 12 million Affordable Care Act members to forecast healthcare inflation. In addition to the predicted 8.5% jump in costs for the group market, the consultancy projected a 7.5% increase for the individual market.”
  • The Wall Street Journal reports
    • “The drugmakers Bristol-Myers Squibb and Pfizer plan to sell the widely used blood thinner Eliquis directly to patients at a discounted cash price—a move that follows the Trump administration’s pressure on the industry to cut drug prices.
    • “The companies, which have a joint venture that markets Eliquis, said the new service will allow uninsured or underinsured patients to buy the pill at more than 40% off the current list price starting Sept. 8. The service will provide direct shipping of the drug to patients in the U.S.
    • “The BMS-Pfizer Alliance is committed to increasing patient access and affordability, which is why we are launching this direct-to-patient offering for Eliquis,” said Bristol-Myers Chief Executive Christopher Boerner.” * * *
    • “Eliquis has a list price of $606 for a 30-day supply but will now offer a discounted cash price of $346 a month.”
  • BioPharma Dive notes,
    • “Abbott lowered its sales forecast for the year, citing a drop in diagnostic testing. CEO Robert Ford told investors on Thursday that the company is seeing a drop-off in COVID-19 testing sales, challenges in China’s core laboratory market and a reduction in U.S. foreign aid funding for HIV testing, with a combined impact of more than $1 billion. 
    • “The company reduced its 2025 organic sales growth forecast to a range of 6% to 7%, from the previous forecast of 7.5% to 8.5% shared in the first quarter.
    • “Even with those billion dollars, we’re still forecasting high single-digit growth and absorbing the impact of tariffs,” Ford said.” 
  • Beckers Hospital Review calls attention to “10 healthcare billing fraud cases that Becker’s has reported on since June 30.”
  • The Institute for Clinical and Economic Review posted today
    • “a revised Evidence Report assessing the comparative clinical effectiveness of nusinersen (Spinraza®, Biogen), onasemnogene abeparvovec-xioi (Zolgensma®, Novartis), and risdiplam (Evrysdi®, Genentech) for spinal muscular atrophy (SMA). ICER is also assessing the comparative clinical effectiveness and value of apitegromab (Scholar Rock Holdings) for SMA.”
    • “SMA, in its most common forms, has been a devastating degenerative neurologic disease of infants and children,” said ICER’s Chief Medical Officer, David Rind, MD. “Disease modifying therapies and newborn screening have dramatically altered the course of disease and represent one of the great medical success stories in the past decade. However, we still have important uncertainties about how best to utilize these therapies to provide maximal benefits to those affected.” * * *
    • “ICER evaluated the cost-effectiveness of apitegromab only because it will most likely be used as an add-on therapy to nusinersen or risdiplam. Apitegromab has not yet been approved by the FDA for SMA, and the manufacturers have not yet announced a US price for the therapy if approved. 
    • “ICER has calculated a health benefit price benchmark (HBPB) to be between $4,600 and $30,200 per year.” * * *
    • “This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC on August 1, 2025. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”

Midweek update

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

From Washington, DC

  • The U.S. Office of Personnel Management has posted a bio of its new Director Scott Kupor.
  • USA Today reports,
    • “President Donald Trump signed a law that extends tougher prison sentences for fentanyl trafficking, surrounded by relatives of people who died from overdoses and lawmakers who approved the bill.
    • “Today we strike a righteous blow to the drug dealers, narcotic traffickers and criminal cartels,” Trump said. “We take a historic step toward justice for every family touched by the fentanyl scourge.”
    • “The law places fentanyl on the Drug Enforcement Administration’s list of most serious drugs with no accepted medical use and a high potential for abuse. The list includes drugs such as heroin, cocaine and LSD. Fentanyl has been temporarily assigned to the Schedule 1 category since 2018. The law makes the designation permanent.
    • “The law also makes permanent mandatory minimum penalties of five years in prison for trafficking 10 grams of fentanyl and 10 years for 100 grams.”
  • Per a Senate news release,
    • “Sens. Chuck Grassley (R-Iowa) and Maggie Hassan (D-N.H.) reintroduced the Healthy Moms and Babies Act to improve maternal and child health care across the nation. The maternal health crisis in the United States particularly affects those living in rural America and women of color. Grassley previously chaired the Senate Finance Committee and continues to serve as a committee member, alongside Hassan.
    • “The legislation builds on Grassley and Hassan’s longstanding efforts to improve maternal and child health by delivering high-quality coordinated care, supporting women and babies with 21st century technology and taking other steps to reduce maternal mortality.” * * *
    • “Additional information on the Grassley-Hassan Healthy Moms and Babies Act is available below:
  • STAT News informs us,
    • “Doctors for decades have been paid using rates developed largely under the advice of the industry’s main lobbying group, the American Medical Association. Experts have railed against the system for decades, calling it complex and filled with self-interested factions that ultimately favor surgeons and higher-priced specialists over primary care clinicians. 
    • “Medicare’s proposal for 2026 would create a so-called “efficiency adjustment” that would reduce payment by 2.5% for thousands of procedures and diminish some of the influence held by the AMA’s advisers, known as the Relative Value Scale Update Committee, or the RUC. 
    • “This is probably one of the most controversial components of this rule,” said Shari Erickson, a top official with the American College of Physicians, which mostly lobbies for primary care doctors. “It is sort of continuing to chip away at some of the concerns that many have raised about the RUC and the power that they’re viewed as having.”
    • “The result is that family medicine doctors and other primary care physicians would see the highest average increases in their payments, per Medicare’s estimates. Dermatologists, gastroenterologists, general surgeons, neurosurgeons, ophthalmologists, orthopedic surgeons, pathologists, and radiologists would experience some of the biggest net decreases to their Medicare pay.
    • “Importantly, the agency would exempt services that are based on time — for example, routine 15- and 30-minute visits performed by primary care physicians. More broadly, Medicare is using the savings from these cuts to bump up the “conversion factor” that dictates the payment rates for all physician services.
    • “Michael Abrams, managing partner of health care strategy firm Numerof & Associates, said this would help fix what’s been a “very serious issue” for decades: the pay imbalance between primary and specialty care.” 
  • The Government Accountability Office released a report on comparative clinical effectiveness research this week.
    • “Comparative clinical effectiveness research compares the success and outcomes of available treatment options for various diseases and conditions. Findings from this research can provide important information on more effective treatments. The Department of Health and Human Services shares these research findings with the public and helps to apply the findings in health care settings.
    • “But we found that HHS hasn’t done a thorough evaluation of these activities. Completing an evaluation will help to show if HHS’s efforts are promoting evidence-based care and, ultimately, improving health outcomes.
    • “Our recommendation [to HHS] addresses this issue.”
  • From the judicial front,
    • Fierce Healthcare lets us know,
      • “Blue Cross and Blue Shield of Kansas City has improperly reduced payments for inpatient services in coordination with third-party vendors, a lawsuit from AdventHealth Shawnee Mission Medical Center alleges.
      • “The hospital claims Blue KC uses clinical validation audits to reject medical diagnoses and declare them “invalid” under “secret and dubious criteria,” in violation of state and federal law, the lawsuit (PDF) says. Blue KC, allegedly, has not paid more than $2 million owed to the AdventHealth hospital after invalidating more than 350 medical diagnoses.
      • “At the crux of the plaintiff’s argument is Blue KC’s relationship with third-party care platforms for providers and payers. The health system has never approved of Blue KC’s relationship with vendors performing clinical validation audits, yet AI technology can supplant a physician’s opinion. Vendors used by Blue KC have publicly touted its AI technology in the past.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced it is revoking, or proposing to revoke, 52 food standards after concluding they are obsolete and unnecessary. The 52 standards are for canned fruits and vegetables, dairy products, baked goods, macaroni products and other foods.
    • “Today’s actions are the first results from the agency’s ongoing analysis of its portfolio of over 250 food Standards of Identity (SOI) to make sure they are useful, relevant and serve consumers in the best possible way. The removal of these standards is in alignment with broader efforts to ensure that HHS is directing resources to where they’re most needed – delivering better outcomes for the American people.”
  • Per Fierce Pharma,
    • “The FDA is raising efficacy questions over Lundbeck and Otsuka’s proposed combination of their Rexulti with Viatris’ Zoloft as a treatment for post-traumatic stress disorder (PTSD).
    • “For an upcoming meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee, the agency is asking an expert panel to weigh in on whether results from an exploratory phase 2 trial and a positive phase 3 study can overcome negative findings from a second phase 3 of the combination.
    • “Discordant results” from the two phase 3 trials have FDA reviewers worried, especially since the agency said it was unable to identify an explanation for the differing outcomes despite “extensive exploratory analyses.”

From the public health and medical research front,

  • Health Day tells us,
    • “Folks using GLP-1 weight loss drugs like Ozempic are more likely to suffer from severe acid reflux, a new study says.
    • “People with type 2 diabetes were more likely to suffer from gastroesophageal reflux disease (GERD) if they were prescribed a GLP-1 drug compared to those taking sodium-glucose cotransporter-2 (SGLT-2) inhibitors, researchers reported today in the Annals of Internal Medicine.
    • “We estimated that most GLP-1 (drugs) increased risk for GERD,” concluded the research team led by Laurent Azoulay, an associate professor with the Jewish General Hospital’s Center for Clinical Epidemiology in Montreal, Canada.
    • “The risk for serious GERD-related complications was higher among smokers, people with obesity and folks with existing stomach problems, researchers said.
    • “Although our findings need to be corroborated in other studies, clinicians and patients should be aware of a possible adverse effect of GLP-1 (drugs) on GERD,” researchers noted.”
  • BioPharma Dive reports,
    • “In experimental, dual-acting obesity drug from Hengrui Pharma and biotechnology startup Kailera Therapeutics succeeded in a Phase 3 trial in China, positioning the companies to seek approval there and to begin global late-stage testing.
    • “The drug, a once-weekly injection dubbed HRS9531, spurred about 18% weight loss in treated participants after 48 weeks, roughly 16% more than those given a placebo. Nearly 9 in 10 people given HRS9531 lost at least 5% of their body weight and over 44% achieved at least 20% weight loss, the companies said Tuesday.
    • “Hengrui and Kailera didn’t disclose specific safety data, only noting that most treatment-emergent adverse events were mild to moderate and gastrointestinal-related. Detailed results will be presented at a future medical meeting. Hengrui will file an approval application in China, while Kailera will initiate global studies that involve higher doses and a longer treatment duration, the startup’s CEO, veteran executive Ron Renaud, said in the statement.”
  • Cardiovascular Business relates,
    • “Vitamin D supplements can help patients reduce their risk of developing cardiovascular disease (CVD), according to a new analysis in Nutrients.[1] In fact, the team behind the new study argued that prior research finding no connection between vitamin D and CVD was flawed.  
    • “The global prevalence of CVD for 2025 was estimated at 598 million, and global CVD deaths at 20.5 million,” wrote first author William B. Grant, PhD, with the Sunlight, Nutrition, and Health Research Center in San Francisco. “Thus, finding ways to reduce the risk of CVD is warranted. There has been a long-standing debate regarding the role of vitamin D in reducing the risk of CVD.”
    • “Grant et al. did note that many randomized controlled trials (RCTs) have found that vitamin supplements fail to reduce cardiovascular risks when compared to a placebo. However, the team added, several other kinds of stories have told another story—and there is a reason for this difference.
    • “RCTs are used for medications to evaluate the use of drugs to prevent and treat diseases,” they wrote. “These drugs are not found in nature, whereas vitamin D is. Additionally, pharmacological agents have narrow dose–response curves. In contrast, nutrients are threshold agents and have broader and often S-shaped dose–response curves.”
  • and
    • “A new-look polymer heart valve is associated with encouraging one-year outcomes in patients undergoing surgical mitral valve replacement (SMVR), according to new data presented at New York Valves 2025 and published in the Journal of the American College of Cardiology.[1]
    • “The Tria mitral valve from Utah-based Foldax is built using LifePolymer, a proprietary material that does not include any animal tissue. Both the frame of the valve and its leaflets are robotically generated to match the patient’s native mitral valve.
    • “The valve made headlines in early June when it was approved for commercial use in India. This represented the first time a polymer heart valve had ever gained such an approval anywhere in the world.”
  • Per a National Institutes of Health press release,
    • “A scientific team supported in part by the National Institutes of Health (NIH) has developed a new, ultra-high-resolution brain imaging system that can reconstruct microscopic brain structures that are disrupted in neurological and neuropsychiatric brain disorders. The new system is a significant advance over conventional magnetic resonance imaging (MRI) scanners that cannot visualize these tiny but clinically important structures.
    • “The system, called the Connectome 2.0 human MRI scanner, overcomes a significant hurdle for neuroscientists: being able to bridge different brain regions and probe tiny structures necessary to define the “connectome,” the complex matrix of structural connections between nodes in the nervous system, and to do it noninvasively in living humans.
    • “This research is a transformative leap in brain imaging – pushing the boundaries of what we can see and understand about the living human brain at a cellular level,” said John Ngai, Ph.D., Director of NIH’s Brain Research Through Advancing Innovative Neurotechnologies® Initiative, or The BRAIN Initiative®. “The new scanner lays essential groundwork for the BRAIN CONNECTSprogram’s ultimate goal of developing a wiring diagram for the human brain.”
    • “The scanner is innovative in two major ways: it fits snugly around the heads of living people, and it has many more channels than typical MRI systems. These advances greatly increase the signal-to-noise ratio of the system, providing much sharper images of very small biological brain structures than previously possible. These technical upgrades will enable scientists to map human brain fibers and cellular architecture down to nearly single-micron precision to study how subtle changes in cells and connections relate to cognition, behavior, and disease.”
  • Per a National Institute of Standards and Technology news release,
    • “In an effort to foster progress in cancer research, the National Institute of Standards and Technology (NIST) is releasing detailed and comprehensive data about the entire genetic content of a pancreatic cancer cell. Scientists can use it to research tumors, improve cancer diagnostic tests, and develop new cancer treatments.
    • “The NIST data on this cancer genome — that is, the full set of genetic instructions from the cell, including the mutations that caused the disease — is several terabytes in size. The genome came from a 61-year-old pancreatic cancer patient who explicitly consented to making the genetic code of her cancer cells publicly available for research and clinical use.”
  • Per STAT News,
    • “One in five individuals who receive a kidney transplant experience a rejection episode within a year. A new approach to donor-recipient matching could help change that.
    • “Mismatches between donors and recipients in SIRP-alpha, an immune cell surface receptor, could contribute to transplant rejection, researchers report in a study published Wednesday in Science Translational Medicine.
    • “What’s groundbreaking about it is that innate immune cells, immune cells that we have not necessarily associated with sensing the graft and attempting to reject it, are now in the center of the rejection battle,” said Fadi Lakkis, a study co-author and professor of nephrology at Stanford University.”
  • and
    • “Ten years ago, U.K. policymakers gave the green light to a pioneering reproductive technology meant to spare children from being born with types of rare but sometimes fatal diseases caused by genetic mutations in the powerplants of cells. The method involved combining not just the genes of a mother and father to produce an embryo, but a bit of DNA from a third person as well. 
    • “On Wednesday, the team in England that has been performing the technique reported that eight healthy babies have been born so far, highlighting that the approach reduced the risk of children inheriting disease-causing mutations in the pieces of DNA contained in our mitochondria. The results, published in a pair of papers in the New England Journal of Medicine, have been long awaited as the first large test of the approach, which is known as mitochondrial replacement therapy or mitochondrial donation. 
    • “All the children are well and continue to meet developmental milestones,” Bobby McFarland, a professor of pediatric mitochondrial medicine at Newcastle University and one of the experts behind the research, told reporters at a press conference in London Wednesday.”
  • and
    • “An oral capsule can efficiently deliver liquid mRNA therapy directly to the gut, a possible new delivery mechanism for mRNA vaccines, a new study finds.
    • “In the study published in Science Translational Medicine on Wednesday, researchers said they successfully used RNACap, a capsule engineered to prevent stomach acids from degrading liquid mRNA therapy to treat inflammatory bowel disease. Once the capsule was in the gut, they used normal stomach contractions to release the mRNA therapy.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “ChristianaCare and Virtua Health are exploring a potential merger that would yield an eight-hospital nonprofit regional health system spanning 10 New Jersey, Delaware, Pennsylvania and Maryland counties.
    • “The systems have signed a nonbinding letter of intent to explore the deal; they announced Wednesday but did not give a timeline for when the combination could be executed. The resulting entity would have almost 30,000 employees, more than 600 sites of care and over $6 billion in annual revenues.
    • “At a time of great uncertainty in health care, ChristianaCare and Virtua Health have the foresight and courage to explore what is possible,” Janice Nevin, M.D., president and CEO of ChristianaCare, said in the announcement. “We are excited to take this bold step to double down on our mission, multiply our excellence and ensure our legacy of high-quality care in our local communities for generations to come.
    • “Together, we aim to create an integrated regional health system built on human connection, clinical excellence and a deep commitment to all people in the communities we serve,” Virtua Health President and CEO Dennis Pullin said.”
  • BioPharma Dive informs us,
    • “Johnson & Johnson on Wednesday reported quarterly prescription drug sales that for the first time surpassed $15 billion, highlighting the strength of the pharmaceutical company’s portfolio during a year in which its formerly top-selling drug lost market exclusivity.
    • “Second quarter sales for J&J’s pharmaceuticals business reached $15.2 billion between April and June, nearly 4% higher than the same period last year on an operational basis. Overall second quarter sales were up 4.6% on the same basis to total $23.7 billion, beating Wall Street forecasts.
    • “J&J now expects higher operational growth for 2025, increasing the midpoint of its guidance range for both adjusted sales and earnings per share.”
  • MedTech Dive relates,
    • “Quest Diagnostics is planning to offer laboratory testing based on Fujirebio Diagnostics’ recently Food and Drug Administration-authorized Alzheimer’s disease blood test.
    • “In May, Fujirebio’s in vitro diagnostic became the first blood test to aid in the diagnosis of Alzheimer’s cleared by the FDA. Quest, which disclosed its plans for the IVD last week, launched a laboratory-developed test for similar biomarkers in April.
    • “The clinical lab plans to make Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test available for use by physicians and researchers this summer.”
  • KFF issued a report about “The Uncertain Future of “Medicare’s Stand-Alone Prescription Drug Plan Market and Why It Matters.”
    • “Ahead of Medicare’s annual mid-year announcement about the national average premium for Part D prescription drug coverage in 2026 and other plan details, two questions loom large for the insurers that sponsor Part D stand-alone prescription drug plans (PDPs) and the 23 million people in traditional Medicare who are currently enrolled in these plans: Will the Trump administration continue Medicare’s Part D premium stabilization demonstration for a second year, and what will the PDP market look like in 2026 and in subsequent years? The answer to the first question could determine whether monthly PDP premiums remain at a relatively affordable level and whether PDP availability remains stable in 2026. The answer to the second question has larger implications for the viability of traditional Medicare as an option for beneficiaries nationwide but especially for beneficiaries who live in rural areas. This is because rural Medicare beneficiaries are more likely to be enrolled in traditional Medicare and rely more on drug coverage from stand-alone PDPs than Medicare Advantage plans.”
  • The Brown & Brown consulting firm explains why employers and health plans should be paying attention to surgical centers of excellence.
  • Per Fierce Healthcare,
    • “Employers have spent several years taking steps to avoid shifting healthcare costs to workers, but as expenses continue to rise, some firms are looking to change course, a new survey shows.
    • “Analysts at Mercer polled 711 employers (PDF), including large and small firms, and found that 51% said they are either likely or very likely to shift costs to employees for their 2026 plans. That’s up from 45% who said the same for 2025, according to the survey.
    • “Of that group, 19% said they were very likely to shift costs and 33% said they were likely to do so in 2026, the survey found. For 2025, 14% of employers said very likely and 31% said likely.
    • “Employers’ healthcare costs grew 4.5% in 2024 and are expected to increase by an average of 5.8% this year, according to Mercer. That figure accounts for cost-saving measures, but costs could rise by an estimated 8% if employers take no action.”

Tuesday report

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

From Washington, DC,

  • The FEHBlog watched the closing of today’s Senate session. He learned that late tomorrow morning the Senate will vote to invoke cloture on the nomination of Scott Kupor to be OPM Director for a four-year term and if cloture is invoked the Senate will vote to confirm Mr. Kupor’s nomination tomorrow afternoon.
  • Govexec tells us,
    • “President Trump on Monday extended his administration’s hiring freeze of all federal civilian positions for another three months, leaving in place the moratorium into the start of fiscal 2026.
    • “The freeze, which the president initially ordered on Jan. 20, the day he took office, prevents the hiring of civilian employees at federal agencies for either vacancies or new positions. The initial executive order was set to run through April 20 and was subsequently extended until July 15.
    • “As with previous orders, the freeze exempts positions related to immigration enforcement, national security or public safety, as well as the components of the Executive Office of the President. The order also reiterated that roles will be filled to protect the “provision of Social Security, Medicare, or veterans’ benefits.” Despite the carveouts, the Defense Department continues to operate under a partial hiring freeze of its own for civilian personnel.” 
  • Per MedTech Dive,
    • “Boston Scientific said Monday it gained Food and Drug Administration approval for use of its Farapulse pulsed field ablation system in people with persistent atrial fibrillation, broadening the pool of patients eligible for the treatment.
    • “Farapulse has become a significant growth driver for Boston Scientific as physicians embrace the technology for its potential safety benefits over traditional cardiac ablation methods to treat AFib, an irregular heartbeat that increases stroke risk.
    • “The label expansion, for both the Farawave and Farawave Nav PFA catheters, was backed by evidence from the first phase of the Advantage AF clinical trial, which met its primary safety and effectiveness goals.”
  • Cardiovascular Business adds,
    • “Boston Scientific has received an expanded approval from the U.S. Food and Drug Administration (FDA) for its Farapulse Pulsed Field Ablation (PFA) System. More U.S. heart patients are now eligible to be treated with the technology than ever before.
    • “The Farapulse PFA system first gained FDA approval to treat patients with symptomatic, paroxysmal atrial fibrillation (AFib) back in January 2024. This new approval covers patients with symptomatic, persistent AFib that is resistant to drug treatment. 
    • “Backed by clinical evidence and our global commercial experience, this update advances our efforts to further shape the future of AFib treatment with safe and effective ablation technologies,” Brad Sutton, MD, chief medical officer of AFib solutions for Boston Scientific, said in a statement. “We look forward to studying the system in new clinical trials, including patients in need of re-do ablations and those with more complex arrhythmias, which account for a large portion of the procedures today still using thermal ablation.”

From the judicial front,

  • The Wall Street Journal reports,
    • “The Supreme Court on Tuesday lifted a halt on President Trump’s plan to shrink the federal workforce, clearing the way for potential mass layoffs. 
    • “In February, Trump issued an executive order aimed at drastically reducing the government’s workforce “by eliminating waste, bloat, and insularity.” The order directed heads of agencies to work with the Department of Government Efficiency on hiring decisions and developing plans for layoffs. In May, a federal judge in San Francisco blocked it from taking effect
    • “The high court, in an unsigned order on Tuesday, said it had based its decision on the legality of Trump’s executive order, and didn’t rule on whether any reorganization plans broke the law.  
    • “The Government is likely to succeed on its argument that the Executive Order and Memorandum are lawful,” the court said. 
    • “Justice Ketanji Brown Jackson dissented, accusing the court of greenlighting legally dubious actions.” * * *
    • “Justice Sonia Sotomayor on Tuesday wrote separately to concur with the court’s decision to lift the halt, noting that the plans themselves weren’t before the high court. She said the district court could still consider the legality of the layoff plans.”
       
  • Fedweek adds,
    • OPM said “hundreds of thousands” of federal employees accepted deferred resignation offers while confirming that “tens of thousands” are facing layoffs in pending RIFs.
    • OPM made that statement in the first—although not exact—accounting of the government-wide impact of those offers, and touted a reduction in the federal employee count on its FedScope site to just under 2.29 million through March, down by some 23,000 from last September.
    • “In addition, hundreds of thousands more workers will drop off the rolls in October 2025, when workers depart the federal government as part of the Deferred Resignation Program; and tens of thousands of employees who have received reduction-in-force or termination notices remain on government payrolls due to court orders that the administration is now challenging,” the OPM said prior to Tuesday’s SCOTUS decision siding with the White House.
  • Per Fierce Healthcare,
    • “Southwest Airlines is buckling up to join in on a long-running legal battle surrounding an alleged price-fixing scheme involving generic medicines in the U.S.
    • “In a 730-page lawsuit filed in federal court in Pennsylvania, the airline targets dozens of drugmakers and argues the companies “deprived the public” of the benefits of cheaper generic drugs by fixing the price of their meds since at least 2009. Among the generic defendants named are Teva Pharmaceutical Industries, Sandoz, Dr. Reddy’s Laboratories, Lupin and Apotex.
    • “The scheme cost Southwest, a large employer that self-funds its employee health plans, “hundreds of millions of dollars” and caused “substantial injury” to its business, the company claims in the recently unsealed lawsuit.” * * *
    • “American Airlines and Target are among other large employers that have sued the group of generic drugmakers. The companies filed a joint lawsuit in the same court back in April 2024, Bloomberg Law reported at the time. 
    • “The issue is also playing out in pending multi-district litigation grouping more than 20 separate lawsuits that date back to 2016. A handful of drugmakers, including Sandoz, Apotex, and Sun Pharma, have so far agreed to multi-million dollar settlements to resolve their end of the claims.” * * *
    • “Southwest, for its part, cited the federal government’s prosecution efforts in its own case. At least seven companies have admitted to criminal wrongdoing, according to the Department of Justice, and have agreed to fork over hundreds of millions of dollars in fines, civil penalties and restitution.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention July 7 announced it is streamlining H5N1 bird flu updates with its routine influenza data given the low public health risk and lack of person-to-person spread. Data on the number of people monitored and tested for bird flu will be reported monthly.
    • “Bird flu detection data in animals will no longer be reported on the CDC website; instead, it will be publicly available on the U.S. Department of Agriculture website.”
  • and
    • “A study published July 7 by JAMA found children’s health has significantly worsened from 2007 to 2023. Researchers studied changes in child mortality; chronic physical, developmental and mental health conditions; obesity; sleep health; early puberty; limitations in activity; and physical and emotional symptoms. Researchers said the findings highlight the need to identify root causes for the decline in health.”
  • Beckers Clinical Leadership lets us know eight things to know about the JAMA report on children’s health.
  • STAT News reports,
    • “Female hearts are different from male hearts, down to their cell populations and up to the thickness of their walls, making cardiovascular care far from one-size-fits-all. There’s a growing appreciation that heart attack symptoms occur on a spectrum. Women may not have the classic crushing chest pain that men do; they may feel a subtler, wider discomfort that can delay care. 
    • “There’s another potentially deadly, dramatic difference. Men are much more likely than women to suffer sudden cardiac arrest, but when female athletes do collapse on the playing field from sudden cardiac arrest, they are less likely than male athletes to be resuscitated right away, despite coaches, trainers, or teammates watching on the sidelines. That’s a disparity women share outside sports events with people of color, whose chances of receiving life-saving help from bystanders are even lower. 
    • “Across disciplines, scientists are arguing for the importance of studying sex differences throughout biomedical research. Sports medicine researchers are also bringing new attention to women, from young competitors in the spotlight to older amateurs trying to stay active.” “
  • Beckers Hospital Review points out,
    • “Mississippi had the highest mortality rate across all cancer types between 2018 and 2022, according to data published by the American Cancer Society. 
    • “The American Cancer Society used data from the North American Association of Central Cancer Registries to calculate mortality rates per 100,000 people for each state and each cancer type.
    • “Read the states with the highest cancer incidence, by type, here.”
  • and
    • “A commonly prescribed medication used to counteract lung cancer therapy side effects could be minimizing a cancer treatment’s efficacy, according to research from Los Angeles-based Keck Medicine of USC. 
    • “To evaluate how baseline steroid use can affect immune checkpoint inhibitor therapy, researchers analyzed clinical outcomes of 277 patients with non-small cell lung cancer. Corticosteroids, a frequently prescribed steroid to treat side effects common to this type of lung cancer, was associated with worse outcomes, the study found. 
    • “Among 88 patients at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., and 189 at the University of Southern California in Los Angeles who received immune checkpoint inhibitor therapy, 21 were taking steroids at the start of ICI therapy. Compared to those not taking corticosteroids, these patients experienced a higher number of negative effects. 
    • “The study, published July 7 in Cancer Research Communications, found a worse overall response rate and shorter overall survival and progression-free survival rates among lung cancer patients taking the steroid concurrent with ICI therapy. 
    • “Additionally, higher doses of corticosteroids severely affected ICI therapy and patient outcomes more than small or medium doses.”
  • Per Health Day,
    • “Some women have expressed concerns about the risk of breast cancer associated with using hormone therapy to treat symptoms of menopause like hot flashes and night sweats, and now, new research suggests that one type of hormone therapy might increase your risk if you’re younger than 55.
    • “Women in this age group who were treated with estrogen plus progestin were more likely to develop breast cancer than those not on hormone therapy, researchers report in The Lancet Oncology.
    • “On the other hand, women younger than 55 given estrogen alone, without progesterone, had a lower risk of breast cancer, results show.
    • “Hormone therapy can greatly improve the quality of life for women experiencing severe menopausal symptoms or those who have had surgeries that affect their hormone levels,” lead author Katie O’Brien, an epidemiologist with the National Institute of Environmental Health Sciences, said in a news release.”
  • Per BioPharma Dive,
    • “Biotech and pharma companies are searching for ways to “hijack” the cell’s waste disposal systems in hopes of making more effective drugs.”
  • and
    • “Glucotrack, which is developing a glucose monitor that is implanted through a minimally invasive surgery, said the small study met safety and performance goals.”

From the U.S. healthcare business front,

  • Risk and Insurance reports,
    • “Medical stop loss claims are undergoing significant shifts as cancer diagnoses remain dominant across all deductible levels while million-dollar claims have doubled in frequency over four years, driven by expensive treatments and rising disease prevalence among younger populations, according to analysis by QBE.” * * *
    • “View the full report here.”
  • Check out Adam J. Fein who writes in Drug Channels,
    • “The 2025 launch of biosimilars to Johnson & Johnson’s Stelara (ustekinumab) marks another turning point in pharmacy benefit dynamics. But unlike the chaotic rollout of Humira biosimilars, pharmacy benefit managers (PBMs) came prepared.
    • “Private label strategies, aggressive pricing, and exclusive formulary deals have transformed what might have been a slow-crawling biosimilar introduction into a full-on pricing war. As with Humira, the reality of biosimilar economics is far messier—and more revealing—than the policy narratives suggest.
    • “In this post, I examine how the major PBMs—and some of the smaller ones—are handling Stelara biosimilars, what’s changed since the Humira experience, and why their strategies reflect the growing dominance of private-label rebating schemes.”
  • Beckers Hospital Review calls attention to “18 health systems that recently had their outlooks upgraded by Fitch Ratings or Moody’s Investors Service in 2025, and considers the state of virtual nursing
    • “Virtual nursing has continued to expand since bursting onto the scene a few years ago. But has the care model lived up to its promise?
    • “Health system leaders told Becker’s that virtual nursing still has room to grow but has had positive benefits for the industry thus far.
    • “While virtual nursing has proven effective at boosting patient outcomes and satisfaction, its broader adoption faces significant barriers: high implementation costs, complex regulatory policies and the challenge of integrating new hospital workflows,” said Zafar Chaudry, MD, senior vice president and chief digital, AI and information officer of Seattle Children’s.”
  • Per Fierce Healthcare,
    • “Nearly all states saw declines in the number of acute care hospitals offering obstetric services between 2010 through 2022, with seven states seeing a quarter or more of their hospitals dropping obstetric care, according to new analysis.
    • “The shutdowns were spread across urban and rural hospitals alike, but more pronounced in the latter. Twelve states lost obstetric services among a quarter or more of their hospitals, and by 2022, there were eight states in which more than two-thirds of all rural hospitals did not offer obstetric care, researchers found.” * * *
    • “Rural hospital obstetrics closures exceeded more than 40% in Pennsylvania (46.2%), South Carolina (46.2%), West Virginia (42.9%) and Florida (40%) between 2010 and 2022. Urban hospital closure percentages were less pronounced among individual states, with Rhode Island (28.6%), Oklahoma (27.6%) and Hawaii (25%) leading the way.
    • “Three states—Delaware, Utah and Vermont—had no hospital obstetric service losses during the study window, as opposed to the seven (Iowa; Oklahoma; Pennsylvania; Rhode Island; South Carolina; Washington, D.C.; and West Virginia) that saw cuts among a quarter or more of their hospitals. Rural-urban divides were also spotted within individual states, such as New Hampshire, where 36.4% of rural hospitals lost obstetrics as opposed to zero urban hospitals.
    • “Access to obstetric care is a key determinant of health outcomes among mothers and infants, the researchers wrote. The study’s findings could be a resource for policymakers and others to craft targeted, state-level interventions addressing access disparity.”
  • and
    • “Humana’s senior-focused primary care unit is set to acquire The Villages Health, which provides care to the large Florida-based retirement community.
    • “The Villages Health filed for bankruptcy last week as it seeks to undergo a strategic restructuring designed to “preserve the business’s day-to-day operations and further enhance patient care.” Humana’s CenterWell has entered a “stalking horse” agreement to buy TVH’s assets, according to an announcement.
    • “Finalizing the sale will require a court order after an auction process that accepts additional bids. As it navigates the sale and bankruptcy proceedings, The Villages Health said it will continue to operate as normal, with the goal of averting disruptions to patient care.
    • “As CenterWell is payer-agnostic, current TVH patients are “expected” to be able to maintain the relationship with their existing providers, according to the release.”

Monday update

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

From Washington, DC,

  • The FEHBlog noticed today that the Speaker of the House of Representatives has declared this week to be a District work week for members of the House. As a result, the previously scheduled House Committee meetings have been cancelled or postponed.
  • Fierce Healthcare reports,
    • “Congress has made permanent a pandemic-era telehealth provision for millions of Americans with high-deductible health plans.
    • “In its massive tax package signed into law on July 4, Congress included a last-minute provision to allow employer-sponsored health plans to offer covered telehealth services before employees meet their deductibles.
    • “Under high deductible health plans, patients typically have to pay out of pocket for healthcare services until they meet their deductible, with an exception for preventive care services. 
    • “Now, employers will be able to offer digital healthcare services to their employees for little to no out-of-pocket cost. The telehealth safe harbor policy also allows employers to waive copays for digital health. 
    • “Congress extended the tax provision multiple times throughout the COVID-19 pandemic to allow commercially insured patients the option to receive care from anywhere. The policy was allowed to lapse at the end of 2024 when it did not make it into the end-of-year healthcare package. 
    • “The telehealth safe harbor policy in reconciliation applies to all plan years beginning after December 31, 2024.”
  • MedPage Today tells us,
    • With the CDC director’s chair still empty, HHS Secretary Robert F. Kennedy Jr. endorsed recommendations made months ago by former members of the Advisory Committee on Immunization Practices (ACIP) to expand access to respiratory syncytial virus (RSV) vaccination, as well as to add a new option for meningococcal vaccination. * * *
    • “A notice this [past] week appeared on the CDC’s website, which details the recommendations from the April ACIP meeting: “With no current CDC Director and pending confirmation of a new CDC Director this recommendation was adopted by the HHS Secretary on June 25, 2025, and is now an official recommendation of the CDC.”
    • The new RSV recommendation calls for a single dose of vaccine for adults age 50 to 59 years who are at increased risk of severe RSV disease. 
    • “The CDC also endorsed the previous ACIP members’ recommendation that GSK’s pentavalent Neisseria meningitidis (groups A, B, C, W, and Y) vaccine (Penmenvy) may be used when both the MenACWY and MenB vaccine are indicated at the same visit. That recommendation applies to healthy people ages 16 to 23 years “when shared clinical decision-making favors administration of MenB vaccine.” The recommendation also covers people age 10 years or older “who are at increased risk for meningococcal disease (e.g., because of persistent complement deficiencies, complement inhibitor use, or functional or anatomic asplenia).” Committee members also voted to include the shot in the Vaccines for Children program.”
  • The Washington Post informs us,
    • “The Department of Veterans Affairs said Monday [July 7] that it will no longer be forced to conduct a large reduction in workforce, unlike several other federal agencies that were forced to make mass layoffs because of the Trump administration’s U.S. DOGE Service.
    • “In a news release, VA said that it was on pace to reduce its total staff by nearly 30,000 employees by the end of this fiscal year, a push that the department said eliminates the need for a “large-scale reduction-in-force.” The announcement marks a significant reversal for the Trump administration, which had planned for months to cut VA by roughly 83,000 employees, according to plans revealed in an internal memo circulated to agency staffers in March.” 
  • MedTech Dive lets us know,
    • “The U.S. plans to charge up to 70% tariffs on imports from some countries starting Aug. 1 as President Donald Trump’s 90-day pause on his country-specific reciprocal duties nears its expiration date.
    • “Starting Monday at noon EST, the U.S. will send letters detailing tariff rates for specific trading partners that have yet to reach a tariff deal with the Trump administration before the pause ends July 9, the president said Sunday. Trump told reporters Friday that the rates would range between 10% and 70%.
    • “The U.S. is specifically focused on “18 important trading relationships,” Treasury Secretary Scott Bessent said on CNN’s “State of the Union” Sunday. He also indicated that countries that do not reach deals in the next few days will return to the tariff rate Trump first outlined as part of the president’s global reciprocal tariff announcement April 2.
    • “President Trump’s going to be sending letters to some of our trading partners, saying that, if you don’t move things along, then, on August 1, you will boomerang back to your April 2 tariff level,” Bessent said.”
  • The American Hospital Association (AHA) News relates,
    • The National Institutes of Health July 3 announced that all NIH-funded research published in scientific journals must be made publicly accessible immediately upon release, accelerating a policy originally set to begin in December. Previously, many NIH-funded studies in journals were password-protected and not widely available to nonsubscribers.

From the judicial front,

  • Healthcare Dive reports,
    • “Six medical groups and a pregnant physician have sued Health and Human Services Secretary Robert F. Kennedy Jr. and his principal deputies over changes made to federal COVID-19 vaccine recommendations.
    • Filed Monday, the lawsuit argues that Kennedy’s directive, which removed guidelines recommending COVID vaccination for pregnant people and healthy children, is unlawful and “a pressing public health emergency that demands immediate legal action and correction.”
    • “The Directive is but one example of the Secretary’s agenda to dismantle the longstanding, Congressionally-authorized, science- and evidence-based vaccine infrastructure that has prevented the deaths of untold millions of Americans,” the suit states.
    • “Plaintiffs include the American Academy of Pediatrics, the American Public Health Association, the Infectious Diseases Society of America and several other groups.”
    • The case is captioned American Academy of Pediatrics v. Kennedy, Case No. 1:25-cv-11916 (D. Mass.).

From the public health and medical research front,

  • Last Wednesday, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced, 
    • “Kraft Heinz Foods Company, a Newberry, S.C., establishment, is recalling approximately 367,812 pounds of fully cooked turkey bacon products that may be adulterated with Listeria monocytogenes (Lm). The turkey bacon was produced from April 24, 2025, through June 11, 2025. The following products are subject to recall [view labels]:
      • “12-oz. vacuum-packed packages of “Oscar Mayer Turkey BACON ORIGINAL” and universal product code (UPC) “071871548601” printed on the packaging under the barcode,”use by” dates ranging “18 JUL 2025” to “02 AUG 2025,” and lot code “RS40.”
      • “36-oz. packages containing three 12-oz. vacuum-packed packages of “Oscar Mayer Turkey BACON ORIGINAL” and universal product code (UPC) “071871548748” printed on the packaging under the barcode, “use by” dates ranging “23 JUL 2025” to “04 SEP 2025,” and lot codes “RS19,” “RS40,” or “RS42.”
      • “48-oz. packages containing four 12-oz. vacuum-packed packages of “Oscar Mayer Turkey BACON ORIGINAL” and UPC “071871548793” printed on the packaging under the barcode and “use by” dates ranging “18 JUL 2025” to “04 SEP 2025,” and lot codes “RS19,” “RS40,” or “RS42.”
    • “The products subject to recall bear the USDA mark of inspection on the front of the label. These items were shipped to retail locations nationwide and some were exported to the British Virgin Islands and Hong Kong.” * * *
    • “FSIS is concerned that some products may be in consumers’ refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.”
  • Per Axios.
    • “It’s not food, it’s not chewing tobacco and it’s not gum — though it might look like it when you see it — but it is becoming America’s new addictive obsession.
    • “Sales of Zyn nicotine pouches are soaring, prompting the tobacco company that makes them to scramble to boost U.S. production to meet demand.” * * *
    • “Threat level: The product is addictive because nicotine is addictive.
      • “But it does not cause cancer since it doesn’t contain tobacco, whose harmful chemicals are carcinogenic. As a result, advocates say nicotine pouches can serve as a safer alternative to smoking.
      • “Philip Morris International U.S. CEO Stacey Kennedy argued that nicotine is “misunderstood” and contains “cognitive benefits.”
      • “You have to be able to separate out the misconceptions of what causes harm — and nicotine is probably one of the most misunderstood compounds, because many people believe that nicotine is responsible for smoking-related disease, and it’s not,” Kennedy said in an interview.
    • Yes, but: Tobacco industry watchdogs say products that contain nicotine, such as pouches and e-cigarettes, can serve as a gateway to smoking, especially for teens.
  • Per MedPage Today,
    • “Parent nudges and clinician feedback/audits boosted HPV vaccination uptake and completion.
    • “Adolescents with the most economic disadvantage, rural kids, and Black children saw the least benefit.
    • “More research is needed to tailor interventions to improve HPV vaccine uptake and completion for these groups.”
  • The American Medical Association lets us know what doctors wish their patients knew about hyperthyroidism.
  • Consumer Reports, writing in the Washington Post, points out “What to eat to protect your aging muscles. The foods you choose are as important as exercise for getting and staying strong.”
  • BioPharma Dive informs us,
    • After a delay due to “resource constraints,” the Food and Drug Administration on Monday [July 7] approved Kalvista Pharmaceuticals’ pill Ekterly to treat swelling attacks in people with the rare disorder hereditary angioedema.
    • Ekterly is the first oral drug to treat hereditary angioedema, or HAE, attacks, competing with shots like Firazyr from Takeda and Ruconest from Pharming. Analysts have estimated Ekterly, Kalvista’s first marketed drug, could bring in $600 million a year in U.S. sales at its peak.
    • The FDA delayed the decision beyond its June 17 deadline, Kalvista said, because of a “heavy workload and limited resources.” While Kalvista awaited its decision, the FDA granted approval to another HAE drug, CSL’s Andembry, a preventive shot that won’t compete directly with Ekterly.
  • STAT News reports,
    • “Apogee Therapeutics said Monday [July 7] that its experimental antibody treatment alleviated the signs and symptoms of atopic dermatitis, a common inflammatory skin condition, far more than a placebo — achieving the efficacy goals of a mid-stage clinical trial.
    • “In a side-by-side comparison, the Apogee drug, called APG777, showed similar skin-clearance rates compared to two antibody treatments already on the market: Sanofi and Regeneron’s Dupixent and Ebglyss from Eli Lilly. 
    • “APG777 was designed to be injected quarterly or twice-yearly, which, if proven in later clinical trials, would make it more convenient than the twice-monthly and monthly injections required for its competitors.” 
  • and
    • “Cogent Biosciences said Monday that its experimental drug reduced the symptoms of a chronic immune disorder called indolent systemic mastocytosis. The results mean the drug achieved the goals of a Phase 3 study, but a comparison to a rival treatment from Blueprint Medicines remains muddled. 
    • “In its study, Cogent’s drug, called bezuclastinib, showed a 24-point improvement in a patient-reported symptoms score, compared to a 15-point improvement for participants given a placebo. The nine-point difference was statistically significant. 
    • “Indolent systemic mastocytosis is the most common form of an immune system disorder that causes allergic-like skin reactions, gastrointestinal and neurological symptoms, fatigue, and generalized pain.” 

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Molina Healthcare warned higher medical costs will hit earnings this year, adding to Wall Street worries.
    • “New legislation will shrink the number of insured, especially Medicaid, creating uncertainty for insurers.
    • “Insurers are seeing that rising mental-healthcare use and costly drugs, like weight-loss medications, increase spending.”
  • Per MedPage Today, “Obesity Drug Prices Are Dropping, but Getting a Steady Supply Remains a Challenge — Insurance coverage remains inconsistent.”
  • Beckers Hospital Review lets us know,
    • “A new study suggests that the introduction of a real-time prescription benefit tool did not lead to meaningful changes in prescription spending or medication use among Medicare Advantage beneficiaries during its first year of implementation. 
    • “The analysis, published in JAMA Network Open, examined more than 2.8 million beneficiaries and compared patients treated with access to the tool to those without it. The tool, integrated into EHRs in 2019, helps provide clinicians with real-time cost and coverage information at the point of prescribing. 
    • “Despite hopes that the tool would lower out-of-pocket costs and increase prescription adherence by guiding prescribers toward lower cost alternatives, the study found no significant difference in total prescription spending, out-of-pocket costs or number of prescription fills between the two groups.” 

Monday report

David Ermer–CMS, Congress, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare–

From Washington, DC.

  • The Wall Street Journal reports,
    • “Senate Republicans trudged through a marathon session Monday, aiming to pass the party’s “big, beautiful bill” and move the legislation one step further toward President Trump’s desk ahead of lawmakers’ self-imposed July 4 deadline.
    • “Voting on amendments and procedural motions started midmorning and dragged through the day as Republican leaders worked to find a balance of policies that could pass both the Senate and later the House. Trump spoke with congressional leaders by phone, and the White House said it was confident that the bill was on track even as its fate and final content remained uncertain.” * * *
    • “A final Senate vote could come late Monday or early Tuesday. If it passes, the measure would then move back to the House, where Republicans have a 220-212 majority. Moderate House Republicans argue that the Senate cut Medicaid too deeply. Others warn that the Senate is violating the House’s target that keeps tax cuts at most $2.5 trillion larger than spending cuts.” 
  • Modern Healthcare reports,
    • “Home health companies stand to lose more than $1 billion in Medicare payments under a proposed rule the Centers for Medicare and Medicaid Services published Monday.
    • “The proposed changes would represent a decrease of 6.4%, or $1.14 billion, in Medicare payments to home health agencies in 2026 compared with 2025, CMS said in a fact sheet.
    • “The proposed home health prospective payment system update includes a 2.4%, or $425 million, increase, which is offset by a 3.7%, or $655 million, decrease reflecting a proposed behavior adjustment required by statute. It also includes a 4.6%, or $815 million, decrease that reflects a proposed temporary adjustment and an estimated 0.5%, or $90 million, decrease based on a proposed update to the fixed dollar loss ratio.”
  • Per a CMS announcement,
    • “On June 30, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update payment rates and policies under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2026. This proposed rule would also update the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2026 and proposes to update requirements for the ESRD Quality Incentive Program (QIP).
    • “For CY 2026, CMS is proposing to increase the ESRD PPS base rate to $281.06, which CMS expects would increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 1.9%. The CY 2026 ESRD PPS proposed rule also includes a proposed payment adjustment for certain non-labor costs for ESRD facilities located in Alaska, Hawaii, and the United States (U.S.) Pacific Territories. 
    • “CMS is proposing shortening the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) survey to 39 questions, removing 23 questions, and eliminating three health equity reporting measures from the ESRD QIP. Additionally, CMS is seeking input on health IT use in dialysis facilities; and input on future measure concepts. CMS also is proposing the early termination of the ESRD Treatment Choices Model.”
  • The public comment deadline for both rules is sixty days after publication in the Federal Register.
  • Per another CMS announcement,
    • “The Justice Department today announced the results of its 2025 National Health Care Fraud Takedown, which resulted in criminal charges against 324 defendants, including 96 doctors, nurse practitioners, pharmacists, and other licensed medical professionals, in 50 federal districts and 12 State Attorneys General’s Offices across the United States, for their alleged participation in various health care fraud schemes involving over $14.6 billion in intended loss. The Takedown involved federal and state law enforcement agencies across the country and represents an unprecedented effort to combat health care fraud schemes that exploit patients and taxpayers.
    • “Demonstrating the significant return on investment that results from health care fraud enforcement efforts, the government seized over $245 million in cash, luxury vehicles, cryptocurrency, and other assets as part of the coordinated enforcement efforts. As part of the whole-of-government approach to combating health care fraud announced today, the Centers for Medicare and Medicaid Services (CMS) also announced that it successfully prevented over $4 billion from being paid in response to false and fraudulent claims and that it suspended or revoked the billing privileges of 205 providers in the months leading up to the Takedown. Civil charges against 20 defendants for $14.2 million in alleged fraud, as well as civil settlements with 106 defendants totaling $34.3 million, were also announced as part of the Takedown.
    • “Today’s Takedown was led and coordinated by the Health Care Fraud Unit of the Department of Justice Criminal Division’s Fraud Section and its core partners from U.S. Attorneys’ Offices, the Department of Health and Human Services Office of Inspector General (HHS-OIG), the Federal Bureau of Investigation (FBI), and the Drug Enforcement Administration (DEA). The cases were investigated by agents from HHS-OIG, FBI, DEA, and other federal and state law enforcement agencies. The cases are being prosecuted by Health Care Fraud Strike Force teams from the Criminal Division’s Fraud Section, 50 U.S. Attorneys’ Offices nationwide, and 12 State Attorneys General Offices.”
  • The Washington Post shares some details about the Takedown.
  • The GAO issued a report today titled “Highlights of a Forum: Reducing Spending and Enhancing Value in the U.S. Health Care System.”
    • “Health care spending per capita is higher in the U.S. than in any other high-income country. Yet, people living in the U.S. don’t live as long in comparison and are more likely to die of conditions that can be prevented or treated.
    • “To find ways to help address this disparity, we convened a forum in October 2024. Experts from government, academia, and industry identified changes to the health care system that could lower costs and improve patients’ outcomes. These include improving primary care, expanding the health care workforce, and reforming health care pricing and payments.”

From the judicial front,

  • The Supreme Court accepted the Solicitor General’s recommendation by declining to review a U.S. Court of Appeals for the 10th Circuit pro-ERISA preemption opinion captioned PCMA v Mulready (S. Ct. No 23-1213). What’s good for ERISA preemption is good for FEHB preemption.

From the public health and medical research front,

  • Health Day reports,
    • “A person’s body fat percentage provides a better estimate of their risk for early death than their body mass index (BMI), a new study says.
    • “People with a high body-fat percentage were 78% more likely to die within 15 years from any cause and 3.6 times more likely to die from heart disease, researchers reported June 24 in the Annals of Family Medicine.
    • “On the other hand, BMI — an estimate of body fat based on height and weight — was not associated with a statistically significant higher risk of death from any cause, researchers found.
    • “Waist circumference also proved to be more accurate than BMI in assessing the risks posed by excess weight, researchers added.
    • “This is a game changer for body composition assessment,” lead researcher Arch Mainous III, a professor of health services, management and policy at the University of Florida, said in a news release.”
  • The American Medical Association lets us know what doctors wish patients knew about cosmetic dermatology.
  • Endocrinology Advisor tells us, “Compared with self-monitoring, continuous glucose monitoring did not improve obstetric or neonatal outcomes among women with gestational diabetes.”
  • Per Medscape,
    • The American College of Gastroenterology (ACG) has issued updated guidance on the management of Crohn’s disease (CD) that reflects the surge in development of therapeutic options available since 2018, when the last guideline was published.
    • These newer treatment options include interleukin-23 (IL-23) blockers risankizumab, mirikizumab, and guselkumab; the anti-IL-12/23 agent ustekinumab; the Janus kinase inhibitor upadacitinib; and the anti-integrin vedolizumab.
    • The intent of the guideline is to suggest “preferable approaches” to CD management established through “interpretation and collation of scientifically valid research, derived from extensive review of published literature,” said the writing group, led by Gary Lichtenstein, MD, director, Inflammatory Bowel Disease Center, Hospital of the University of Pennsylvania, Philadelphia.
  • Per a National Institutes of Health press release,
    • “Scientists at the National Institutes of Health (NIH) have found that two common types of hormone therapy may alter breast cancer risk in women before age 55. Researchers discovered that women treated with unopposed estrogen hormone therapy (E-HT) were less likely to develop the disease than those who did not use hormone therapy. They also found that women treated with estrogen plus progestin hormone therapy (EP-HT) were more likely to develop breast cancer than women who did not use hormone therapy. Together, these results could help to guide clinical recommendations for hormone therapy use among younger women.
    • “The two hormone therapies analyzed in the study are often used to manage symptoms related to menopause or following hysterectomy (removal of uterus) or oophorectomy (removal of one or both ovaries). Unopposed estrogen therapy is recommended only for women who have had a hysterectomy because of its known association with uterine cancer risk.
    • “Hormone therapy can greatly improve the quality of life for women experiencing severe menopausal symptoms or those who have had surgeries that affect their hormone levels,” said lead author Katie O’Brien, Ph.D., of NIH’s National Institute of Environmental Health Sciences (NIEHS). “Our study provides greater understanding of the risks associated with different types of hormone therapy, which we hope will help patients and their doctors develop more informed treatment plans.”
  • The Wall Street Journal reports,
    • “Moderna said Monday its seasonal influenza vaccine candidate, mRNA-1010, showed superior efficacy in a Phase 3 study that compared it with a licensed standard-dose seasonal flu vaccine in adults aged 50 years and older.
    • “MRNA-1010 achieved the most stringent superiority criterion prespecified in the study protocol, with a relative vaccine efficacy of 26.6% in the overall study population, Moderna said.
    • “Subgroup analyses confirmed a consistently strong relative vaccine efficacy point estimate across age groups, risk factors and previous influenza vaccination status, it said. In participants aged 65 years and older, mRNA-1010 demonstrated a relative vaccine efficacy of 27.4%.
    • “The severity of this past flu season underscores the need for more effective vaccines,” Moderna Chief Executive Stephane Bancel said.”
  • BioPharma Dive points out the top 10 clinical trials to watch in the second half of 2025.
    • “Expected readouts in obesity, lung cancer and atopic dermatitis headline a series of study results that could give the biotechnology sector a boost in another down year.”

From the U.S. healthcare business front,

  • Beckers Payer Issues relates,
    • “Clear answers to questions are the top driver of members’ experience with their insurers, according to a report from Forrester. 
    • “The research firm scored insurers on the brand experience index, which measures customers’ and noncustomers’ brand perception, and customer experience index, which rates customer service and loyalty. 
    • “The health insurance industry had the lowest overall consumer ratings of the 10 industries studied by Forrester. 
    • “Based on consumer responses, Forrester rated answering questions with clear answers as the top driver of customer experience. Across the industry, 60% of consumers said their insurer answered questions clearly. CareFirst BlueCross BlueShield, the industry leader in this category, scored 71%. 
      • “Here are the five other key drivers of total experience for insurers, and insurers’ average scores, according to Forrester:
      • “Keeps personal and financial information secure: 54% 
      • “Helps manage care: 53% 
      • “Offers needed healthcare plans and services: 59% 
      • “Resolves problems on the first call: 56% 
      • “Has a website that meets customers’ needs: 58%” 
  • Modern Healthcare reports,
    • “OptumRx is removing prior authorization mandates for more drugs. 
    • “So far this year, the pharmacy benefit manager has eliminated reauthorizations for 140 medications patients use to treat chronic conditions, the UnitedHealth Group subsidiary said in a news release Monday. Insurance companies and PBMs require patients and clinicians to obtain reauthorizations for some drugs in cases of long-term safety concerns or potential dosing changes. Beginning Tuesday, OptumRx will cut prior authorizations for another 60 medications that treat seven chronic conditions, including HIV, high cholesterol, hypertension and and others. 
    • “Eliminating reauthorization requirements for established and effective treatments underscores our commitment to make these needed drugs more accessible, which also supports better health outcomes,” Dr. Sumit Dutta, chief medical officer, said in the release.”
  • OptumRx, writing in LinkedIn, discusses taking action against drug price hikes.
  • Healthcare IT News notes, “Taking a patient history upfront via telemedicine has been very fruitful for the high-demand specialty provider [the Kennedy-Krieger Institute]. By combining history via virtual care with a then more limited in-person visit, care can be delivered more efficiently to more patients.”
  • Per Beckers Hospital Review,
    • “Nearly 800 rural U.S. hospitals are at risk of closure due to financial problems, with about 40% of those hospitals at immediate risk of closure.
    • “The count is drawn from the Center for Healthcare Quality and Payment Reform’s most recent analysis, based on hospitals’ latest cost reports submitted to CMS and verified as current through June 2025. The analysis identifies two distinct tiers of rural hospital vulnerability: those at risk of closure and those facing an immediate risk of closure. * * *
    • [The article] includes a state-by-state listing of the number of rural hospitals at risk of closure in the next six to seven years and at immediate risk of closure over the next two to three years. 
  • BioPharma Dive reports,
    • “Abbvie has agreed to acquire cell therapy developer Capstan Therapeutics in a deal worth up to $2.1 billion, the companies announced Monday. 
    • “The acquisition will hand AbbVie access to technology developed by Capstan that uses small fatty spheres known as lipid nanoparticles to deliver into the body genetic instructions able to engineer specific cells. It’s an ambitious scientific approach that blends the science behind CAR-T cell therapy with that of messenger RNA vaccines.
    • “Capstan is a few weeks removed from dosing the first patient in a Phase 1 trial of its lead drug candidate, which it’s testing as treatment for B cell-mediated autoimmune diseases. Dubbed CPTX2309, the therapy is designed to reprogram immune T cells to target a protein called CD19 that’s commonly found on B cells.”

Midweek report

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

From Washington, DC

  • Roll Call tells us,
    • “House Republicans rescued their “big, beautiful” reconciliation bill from an early death in the Senate Wednesday by passing a measure deleting various provisions that would have violated Senate budget rules.
    • “To avoid a stand-alone vote on the fixes, automatic adoption of the resolution correcting the engrossment of the House reconciliation bill was embedded in a rule needed for floor debate of an unrelated bill that would cancel $9.4 billion in foreign aid and public broadcasting funds. The House adopted the rule on a nearly party-line vote of 213-207.
    • “Rules Chairwoman Virginia Foxx, R-N.C., said during floor debate that no new provisions were added to the reconciliation bill. She said the corrections measure only deleted some provisions for technical reasons “to make sure this big, beautiful bill has its day in the Senate.”
  • The American Hospital Association News informs us,
    • “The Senate Health, Education, Labor, and Pensions Committee today released its text for the budget reconciliation bill. The text includes one health care provision, which would fund cost-sharing reduction payments to insurers in Affordable Care Act marketplaces. It also includes several policies related to student loan and repayment programs, including the termination of the Grad PLUS loan program effective July 1, 2026, and a change to the Public Service Loan Forgiveness Program for new borrowers that would not allow medical or dental residents to count their time in residency as qualifying payments for loan repayment.” 
  • STAT News reports,
    • “Senate health committee Chair Bill Cassidy (La.) is the latest Republican to take an interest in legislation that would tie U.S. brand drug prices to lower prices in other wealthy countries, according to seven people following the issue.” * * *
    • “Trump last month announced plans for pushing U.S. drug prices down to foreign levels, and more details are supposed to be forthcoming. However, it’s not clear that the administration could pressure drugmakers into matching the prices they charge abroad, which are typically much lower, without Congress passing a law that requires them to do so.” * * *
    • “After Trump’s announcement, Sen. Josh Hawley (R-Mo.) also introduced a bill with Sen. Peter Welch (D-Vt.) that would base U.S. prices on what other countries pay. 
    • “Cassidy’s bill would apply to Medicare prices, while the Hawley/Welch bill would apply to all retail drugs, not just those for which Medicare pays. 
    • “The Cassidy bill would instruct Medicare to claw back what it is owed when drugmakers charge prices that are higher than the foreign reference prices. It sets criteria for the countries that would be used to set prices, and Medicare would maintain that list. 
    • ‘The Hawley/Welch bill enforces its requirement for lower prices with civil monetary penalties that are 10 times the difference between the U.S. list price and the average price of the drug sold in Canada, France, Germany, Japan, Italy, and the United Kingdom.”    
  • The Washington Post reports,
    • Health and Human Services Secretary Robert F. Kennedy Jr. named eight people to the influential federal panel that recommends vaccines to Americans Wednesday, elevating several vaccine critics days after he purged the group’s entire membership.
    • His picks for the Advisory Committee on Immunization Practices include a well-known pediatric infectious diseases expert and at least two people who have criticized the use of mRNA coronavirus vaccines. Some of the more notable selections include Martin Kulldorff, the co-author of the Great Barrington Declaration * * * and Vicky Pebsworth, who has been listed on the board of the nation’s oldest anti-vaccine group.
    • “All of these individuals are committed to evidence-based medicine, gold-standard science, and common sense,” Kennedy said in a Wednesday X post announcing the picks. “They have each committed to demanding definitive safety and efficacy data before making any new vaccine recommendations.”
    • “The other new members are Joseph R. Hibbeln, a psychiatrist; Retsef Levi, a professor of operations management; Robert W. Malone, a biochemist; Cody Meissner, a pediatrician; James Pagano, an emergency medicine physician; Michael Ross, a professor of obstetrics and gynecology.”
  • Federal News Network relates,
    • “More than 460 laid-off employees at the nation’s top public health agency received notices Wednesday that they are being reinstated, according to a union representing the workers.
    • “The U.S. Department of Health and Human Services confirmed reinstatement notices went out to the former Centers for Disease Control and Prevention employees but provided few details.
    • “About 2,400 CDC employees lost their jobs in a wave of cuts across federal health agencies in early April, according to a tally at the time.” * * *
    • “An estimated 200 of the reinstated workers are based in the CDC’s National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention, HHS officials confirmed. Staffers at a CDC lab that does testing for sexually transmitted diseases are being brought back, said one CDC employee who wasn’t authorized to discuss what happened and spoke to The Associated Press on condition of anonymity.
    • “Also reinstated are an estimated 150 employees at the CDC’s National Center for Environmental Health, including people staffing a lab that works on lead poisoning, according to the union and employees.”
  • Per Fierce Pharma,
    • “Nine years after selling Medivation to Pfizer for $14 billion, David Hung, M.D., is going toe to toe with the New York drugmaker and two other pharma giants in a lung cancer field.
    • “Hung’s Nuvation Bio has won FDA approval for Ibtrozi, or taletrectinib, to treat patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). With the nod, Ibtrozi will go up against existing medicines from Pfizer, Bristol Myers Squibb and Roche.
    • “ROS1 is a well-established subset of NSCLC. As it stands, Roche’s Rozlytrek is largely duking it out with BMS’ Augtyro, while Pfizer’s first-generation tyrosine kinase inhibitor (TKI) Xalkori gradually falls out of favor.
    • “However, ROS1 NSCLC has not been viewed as a major market opportunity, with combined Rozlytrek and Augtyro sales reaching roughly $200 million in 2024 despite their additional uses in NTRK gene fusion-positive solid tumors.
    • “But Hung believes Ibtrozi boasts a unique profile that could allow the next-generation TKI to reach new heights. For their part, analysts at Jefferies see potential for the Nuvation drug to become a blockbuster.”

From the public health and medical research front,

  • STAT News points out,
    • “Deaths from alcohol-related liver diseases have been rising for years — and at an accelerated rate for groups including women, young adults, and Indigenous people. New data suggest a surge in deaths in the early months of the pandemic has continued in subsequent years. 
    • “The study presents a discouraging picture of the nation’s liver health. Between 2018 and 2022, the most recent year for which mortality data are available, the annual percentage change in alcohol-associated liver disease deaths was nearly 9%, compared to 3.5% between 2006 and 2018. 
    • “Men still made up the bulk of these deaths, with 17 deaths per 100,000 people. But women’s death rates sped up, jumping up to 8 deaths from 3 per 100,000 people in the time period studied. On average, the annual percent change in women’s mortality was 4.3% — nearly twice that of men. Researchers also highlight a worsening trend of sudden and dangerous liver inflammation appearing in young people.
    • “While alcohol-associated liver disease (ALD) mortality was relatively stable from 1999 to 2006, it’s been on the rise since then, and has worsened especially since 2018, according to findings published Wednesday in JAMA Network Open. Experts know the pandemic had something to do with that change, since studies suggest people drank more during the Covid era. But new data, and the continuing influx of younger patients with severe illness, further troubles liver doctors and public health researchers. 
    • “It puts numbers to what we’re seeing in the hospital, in the clinic,” said Brian Lee, a hepatologist and liver transplant specialist at Keck Medicine of USC who was not involved with the study.”
  • The American Journal of Managed Care lets us know,
    • “In the process of recovering from COVID-like symptoms, mental health and well-being took close to 3 times as long to recover compared with physical health, according to new research published online today. These new data from December 2020 through the end of August 2022 show that although physical health tends to bounce back by 3 months after symptoms became apparent, mental well-being can take up to 9 months to reach a comparable level of recovery.
    • “In Open Forum Infectious Diseases, these findings and additional data from the CDC’s INSPIRE project (Innovative Support for Patients with SARS-CoV-2 Infections Registry; NCT04610515) shed new light on recovery after COVID-like symptoms.1 The study authors also highlight that up to 1 year after infection, close to 20% of patients continued to report a reduced health-related quality of life (HRQOL) vs before their self-reported COVID-like symptoms, and that there is potential for underestimation of other illnesses because of this; among their study population, health recovery recovered to a higher level for those who reported COVID-like symptoms vs those who tested negative.
    • “For patient prognostics, we found somewhat more pronounced recovery (i.e., return to the optimal HRQOL) for those in the COVID+ group compared to the COVID− groups, after adjustment,” the study authors wrote. Their results speak to the need for ongoing vigilance on the part of health care providers toward their patients’ mental health throughout recovery and to tailor care strategies accordingly.”
  • Per MedPage Today,
    • “CT colonography, also known as virtual colonoscopy, reduced the incidence of colorectal cancer by up to 75% versus no screening, while stool DNA testing reduced the incidence by 59%.
    • “Stool testing was cost-effective relative to no screening, while CT colonography was actually cost saving.
    • “CT colonography should be considered a legitimate first-line screening option along with stool testing and optical colonoscopy.”
  • Per Medical News Today,
    • As people are living longer, there is a greater emphasis on healthy aging. 
    • Diet is one aspect that can contribute to healthier aging.
    • A new study found that consuming more foods and beverages rich in flavonoids may help lower a person’s risk of certain aspects of unhealthy aging, such as frailty and poor mental health.
    • Flavonoids are found in a variety of fruits, vegetables, and plant-based foods, such as: 
      • Berries like blueberries and raspberries; Citrus fruits like oranges and grapefruit; Dark chocolate; Fruits such as peaches and bananas; Green and black tea; Leafy greens such as kale and spinach; Red wine; Vegetables such as peas, onions, and tomatoes
  • The Washington Post relates,
    • “With a silly smile and frilly gills, the axolotl has wriggled its way into the hearts of millions, becoming a popular aquarium pet and pop culture icon in video games, children’s books and toy stores.
    • “But this adorable species of salamander is also helping researchers investigate a serious medical mystery: Could the human body be coaxed to regrow a severed arm or leg?
    • “Scientists are turning to the axolotl because it is an expert at regeneration. After losing a limb, an adult axolotl can grow it back fresh and new.
    • “In a study published in the journal Nature Communications on Tuesday, scientists used axolotls genetically engineered to glow in the dark to understand the molecular underpinnings of this amazing trait.
    • “This species is special,” said James Monaghan, a Northeastern University biologist who led the research. They’ve “really become the champion of some extreme abilities that animals have.”
  • GenEdge reports,
    • “Scientists at the Max Planck Institute for Metabolism Research have identified a network of nerve cells that may be responsible for a reduction in feelings of hunger that may be felt as a result of smelling food, in mice. The team discovered a direct connection from the nose to a group of nerve cells in the brain that are activated by the smell of food and, when activated, trigger a feeling of fullness in lean mice, but not in obese mice. The discovery may suggest that treating obesity might require different advice about smelling food before a meal based on a person’s weight.
    • “Our findings highlight how crucial it is to consider the sense of smell in appetite regulation and in the development of obesity,” said study lead Sophie Steculorum, PhD, research group leader at the Max Planck Institute for Metabolism Research. “Our study shows how much our daily-lives’ eating habits are influenced by the smell of food. Since we discovered that the pathway only reduces appetite in lean mice, but not in obese mice, our study opens up a new way to help prevent overeating in obesity.”
  • The Wall Street Journal reports,
    • “Some health-obsessed Americans believe the next antiaging therapeutic already exists—in the medicine cabinets of millions of diabetes patients.
    • “The widely used class of drugs, called SGLT2 inhibitors and sold under brand names such as Jardiance and Farxiga, have been on the market for over a decade as Type 2 diabetes medications. They have also gained regulatory approval to treat conditions like heart failure and kidney disease. 
    • ‘Recently, though, the drugs have emerged as a hot topic on popular health podcasts and Reddit forums for longevity enthusiasts, many of whom don’t suffer from any of those conditions. Instead, they are adding SGLT2 inhibitors to a roster of hacks they hope will help them live healthier for longer—or in other words, increase their healthspan.” * * *
    • “This is probably the drug class of our era,” says Dr. Timothy Gong, section physician leader for heart failure and transplant cardiology at Baylor University Medical Center, who has researched SGLT2 inhibitors. “You see cardiologists, nephrologists, endocrinologists, even general internists as well, just getting so excited.”
    • “Gong says he wouldn’t be surprised to take an SGLT2 inhibitor one day, once they are studied more, though he’s free from heart issues and diabetes. Yet it’s too early to prescribe it for longevity benefits in otherwise healthy patients. 
    • “I don’t think that the evidence is strong enough yet for us to be able to say that,” he says.” 

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Risant Health CEO Dr. Jaewon Ryu said the new nonprofit system is making progress rolling out the first wave of its value-based care platform.
    • “The system is growing quickly, having completed two acquisitions in the past year-and-a-half. Oakland, California-based Kaiser Permanente launched Risant in early 2024 with the acquisition of Geisinger Health, followed by another deal in December to buy Cone Health. Kaiser formed Risant as a separate entity to acquire health systems and create a national value-based care network.
    • “As Risant expands, it is implementing a gameplan for value-based care throughout its footprint, ranging from primary care guidelines to technological tools that can help improve patient care.”
  • The Pharmacy Times discusses “The Role of Pharmacists in Cardiovascular Health: A Collaborative Approach to Treatment, Counseling, and Nutrition.”
  • Per Fierce Healthcare,
    • NeuroFlow, a behavioral health tech company, has launched a suite of analytics tools to help payers and providers understand population risk.
    • BHIQ is a standalone product built on the analytics work NeuroFlow has already routinely been doing for years. It leverages existing data, like historical EHR, claims and pharma data, to predict the behavioral health needs of a population or a patient. It also helps organizations understand the efficacy of their interventions. NeuroFlow piloted BHIQ with a number of partners including commercial payers, Medicaid and Medicare Advantage plans and ACOs. 
    • “This certainly is not meant to be a replacement to a diagnostic tool, and it’s not meant to diagnose issues,” NeuroFlow CEO Chris Molaro told Fierce Healthcare. “It’s more of a compass to help point them in the right direction and give them insight into where there may be risk—and then stratify that risk.” 
    • “BHIQ is meant to complement NeuroFlow’s other offerings, though it can be purchased separately. Compared to the company’s product for measurement-based care, which draws on patient-reported outcomes questionnaires, BHIQ does not require patients to download an app or respond to surveys. This means organizations have another pathway for data analysis.”
  • and
    • “Alternative pharmacy benefit manager and administrator Capital Rx is acquiring Amino Health, a care navigation company.
    • “The acquisition, the company said, will allow Capital Rx to offer a better member-facing experience to complement its unified claims platform on the back end.” * * *
    • “Amino Health CEO John Asalone positions the company as helping large, self-insured employers (often Fortune 100 companies) lower their costs through a sleek interface helping members search for top-rated providers, view integrated cost estimates, uncover prescription drug savings and book appointments easily. This allows members to not only search by medical provider or procedure but also search for drugs like GLP-1s.”
  • and
    • “Blue Shield of California has teamed up with Zocdoc for members to more easily schedule in-person appointments with providers in their health plan network, the companies announced on Wednesday. 
    • “Zocdoc connects consumers with primary care providers and specialists and to see their schedules and book appointments digitally. Blue Shield of California is bringing that seamless digital experience to its members to facilitate access to covered providers. 
    • “The new feature is available through Blue Shield of California’s searchable provider directory on its website. With the last-mile infrastructure provided by Zocdoc, members can immediately see the participating providers’ availability and book an appointment.”

Monday report

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

From Washington, DC,

Photo by Sven Read on Unsplash
  • The Wall Street Journal reports,
    • “Senate Majority Leader John Thune (R., S.D.) is trying to release this week a revised version of President Trump’s “big, beautiful bill.”
    • “But as he races to pass the legislation ahead of Republicans’ self-imposed July 4 deadline, he has got about as many problems as there are GOP senators, with lawmakers battling over the additional borrowing and spending cuts that will be used to finance tax relief, plus spending on the border and military.
    • “The House in May passed its own version by a one-vote margin, and Trump has urged the Senate to move the multitrillion-dollar bill quickly. But GOP senators want changes, and lawmakers disagree over the depth of cuts to Medicaid, clean-energy tax credits and nutrition assistance, with some seeking to protect their own states’ interests and others accusing colleagues of not taking federal deficits seriously.”
  • The American Hospital Association News tells us,
    • “The White House June 6 issued a memorandum directing the Secretary of the Department of Health and Human Services “to take appropriate action to eliminate waste, fraud, and abuse in Medicaid, including by ensuring Medicaid payments rates are not higher than Medicare, to the extent permitted by applicable law.” In the memo, the administration expresses its view that rapid growth in state directed payment programs [“SPDs”] is a threat to the nation’s long-term stability, and that the “imbalance between Medicaid and Medicare payment rates under these programs jeopardizes access to care for seniors.”  
    • “The memo is in addition to the ongoing congressional reconciliation deliberations, which also include provisions impacting SDPs.”
  • Per HHS news releases,
    • “Jim O’Neill was sworn in today [June 9, 2025] as the Deputy Secretary of Health and Human Services by Secretary Robert F. Kennedy, Jr. With decades of experience at the intersection of health care, technology, and public service, O’Neill will help Kennedy oversee an agency that includes the National Institutes of Health, the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, the Administration for Children and Families, and many others.
    •  “Jim O’Neill’s extensive experience in Silicon Valley and government makes him ideally suited to transition HHS into a technological innovation powerhouse. He will help us harness cutting-edge AI, telemedicine, and other breakthrough technologies to deliver the highest quality medical care for Americans,” said Secretary Kennedy. “As my deputy, he will lead innovation and help us reimagine how we serve the public. Together, we will promote outcome-centric medical care, champion radical transparency, uphold gold-standard science, and empower Americans to take charge of their own health.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) today took a bold step in restoring public trust, links to an external website, opens in a new tab by totally reconstituting the Advisory Committee for Immunization Practices (ACIP), an advisory committee that makes recommendations on the safety, efficacy, and clinical need of vaccines to the Centers for Disease Control and Prevention (CDC). Under the leadership of HHS Secretary Robert F. Kennedy, Jr., the agency removed the 17 sitting members of the ACIP committee and will replace them with new members currently under consideration.” * * *
    • “ACIP will convene its next meeting, links to an external website June 25 through June 27 at CDC headquarters in Atlanta.”

From the Food and Drug Administration front,

  • Per Fierce Pharma,
    • “As several pharma juggernauts prepare for the upcoming respiratory syncytial virus (RSV) season, the FDA has blessed Merck’s entrant. 
    • “The monoclonal antibody, clesrovimab, will be known commercially as Enflonsia and will challenge Sanofi and AstraZeneca’s blockbuster Beyfortus.
    • “Enflonsia has been approved to prevent lower respiratory tract disease from RSV in children who are born during or entering their first RSV season, the U.S. regulator said in a social media post. The nod arrived one day ahead of the agency’s target decision date.” * * *
    • “Meanwhile, Sanofi and AZ have been unchallenged with Beyfortus as the lone prophylactic RSV antibody for children. The drug generated sales of 1.7 billion euros ($1.8 billion) last year. In 2023, reports emerged that demand for the antibody outstripped early supply.
    • “Also Monday, Sanofi said that it and partner AZ have already manufactured as many doses of Beyfortus as they supplied last year and that production remains ongoing. The companies added that they will begin shipping early in the third quarter.
    • “Enflonsia has delivered trial results that suggest it can compete with Beyfortus.” 
  • and
    • “A new era of hypertension treatment is on the horizon for U.S. patients with the FDA approval of George Medicines’ Widaplik, a three-in-one pill that can serve as an initial treatment to help lower blood pressure.
    • “The drug combines established high blood pressure meds telmisartan, amlodipine and indapamide and is the first triple-combination therapy to boast a label from the FDA that allows its use as an early treatment, helping patients who may need multiple drugs to achieve blood pressure goals with one fell swoop. 
    • “Its three dosing options—one low dose and two standard doses—can deliver the benefits of a triple-combo approach “early in the treatment pathway with an established safety profile and good tolerability,” according to a June 9 press release from George Medicines.”
    • “The drug is specifically approved for patients who are likely to need more than one medicine to achieve blood pressure goals.”
  • and
    • “When it comes to the use of PD-1 inhibitors in stomach cancer, the FDA has put its money where its mouth is.
    • “After questioning the benefits of checkpoint inhibitors in stomach cancer cases without PD-L1 expression, the FDA has moved to restrict the use of Merck & Co.’s and Bristol Myers Squibb’s immunotherapies in those patients.
    • “BMS’ Opdivo, used in combination with chemotherapy, is now allowed in advanced or metastatic gastric, gastroesophageal junction (GEJ) and esophageal cancers only among patients whose tumors express PD-L1. Simultaneously, the approval for a combination of Opdivo and BMS’ Yervoy in first-line esophageal squamous cell carcinoma has also been limited to PD-L1-positive disease.
    • “Similarly, the label for Merck’s Keytruda in gastric, GEJ and esophageal cancers has been narrowed to PD-L1-positive tumors as well. The amendment to Keytruda’s gastric or GEJ adenocarcinoma uses only touches HER2-negative disease in this situation because the drug’s HER2-positive approvals in those settings had already been narrowed to PD-L1-positive cases in March.
    • “The revised indications reflect the patient populations for whom the drugs have favorable risk-benefit assessments, the FDA said in two separate letters (PDFs) sent to the drugmakers late May.”
  • Per MedTech Dive,
    • “Baxter has recalled its Novum IQ large volume pump in response to an under-infusion risk linked to one serious injury report, the Food and Drug Administration said Friday.
    • “Baxter is keeping the pumps on the market and updating the instructions to advise users on how to prevent the devices from infusing up to 50% less than the set amount. More than 34,500 units are affected across the U.S. and Canada, according to a recall database entry. 
    • “Variability of 10% or more can put infants at risk of dehydration, inadequate drug therapy and nutrition and insufficient blood infusion, the FDA said, leading to serious harm and death.”

From the judicial front,

  • Fierce Healthcare tells us,
    • “The leading organization representing pharmacy benefit manager companies is now also suing Arkansas officials over its new law banning PBMs from owning pharmacies. 
    • “Joining the Pharmaceutical Care Management Association (PCMA) in the lawsuit as a plaintiff is alternative PBM and founding member of TransparencyRx, Navitus Health Solutions. The lawsuit was filed in the Eastern District of Arkansas against the Arkansas State Board of Pharmacy.”
    • “Express Scripts and CVS Health had sued state officials at the end of May.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Health officials are investigating a salmonella outbreak linked to eggs from August Egg Co. and sold under several brands.
    • “As of June 5, 79 people had been reported infected with the outbreak strain, with at least 21 hospitalizations, the Centers for Disease Control and Prevention said.
    • “The CDC, the Food and Drug Administration and state officials are investigating.
    • “August Egg, of Hilmar, Calif., recalled 1.7 million dozen brown cage-free and brown certified organic eggs.
    • “The eggs were distributed at stores including Walmart, Ralphs, Safeway, Save Mart, FoodMaxx, Lucky, Smart & Final, Raleys and Food 4 Less. Brands include Clover, First Street, Nulaid, O Organics, Marketside, Raleys, Simple Truth, Sun Harvest and Sunnyside.
    • “The eggs were available from various retailers in California and Nevada. Additionally, they were sold at Walmart locations in Washington, Arizona, Wyoming, New Mexico, Nebraska, Indiana and Illinois.”
  • The American Medical Association lets us know what doctors wish their patients knew about myocarditis.
  • Beckers Hospital Review shares information from an “American Cancer Society [study that] used data from the North American Association of Central Cancer Registries to calculate incidence rates per 100,000 people for each state and each cancer type” over the period 2017 through 2021. Kentucky had the highest incidence rate.
  • MedPage Today points out,
    • “Participation in a cervical cancer screening program in a safety-net health system more than doubled when patients received at-home test kits by mail rather than just a telephone reminder to get screened, a randomized trial showed.
    • “Six months after initial contact, 17.4% of patients invited by telephone to attend a clinic-based screening had participated in the program as compared with 41.1% of those who had an at-home test for human papillomavirus (HPV) mailed to them. The participation rate increased to almost 50% among patients who received the home test kit and a follow-up phone call from a patient navigator. More than 80% of screening participants in the two self-collection groups, returned the home test kit as opposed to being tested in a clinic.
    • “The results suggest that use of self-collection test kits could be considered in safety-net settings with low participation in cervical cancer screening programs, reported Jane R. Montealegre, PhD, of the University of Texas MD Anderson Cancer Center in Houston, and co-authors in JAMA Internal Medicineopens in a new tab or window.
    • “Too many women, especially those who are uninsured, live in rural areas, or come from marginalized and underserved communities, aren’t getting screened for cervical cancer,” Montealegre said in a statement. “These results show that self-collection testing could be a solution to increasing access to screening and, in turn, reducing the burden of cervical cancer in the U.S.”
  • and
    • “More widespread and consistent use of pre-exposure prophylaxis (PrEP) has the potential to dramatically reduce the incidence of HIV in the U.S., but substantial barriers to PrEP remain, particularly access, stigma, and non-HIV specialist physicians’ knowledge of the growing slate of options.
    • “New PrEP options on the horizon may help alleviate some of these barriers as physician awareness also increases. 
    • “There’s data from contraception [studies] that if you have more choice, the uptake is higher overall,” Matthew Spinelli, MD, of the University of California San Francisco, told MedPage Today. “PrEP is highly effective, and if the populations that need it had access to it, we would see the end of the HIV epidemic.” 
  • The Wall Street Journal relates,
    • “For patients with a rare type of blood cancer, treatment might finally be coming out of the Dark Ages.
    • “People with the chronic condition polycythemia vera make too many red blood cells, thickening their blood and increasing the risk for clots, heart attacks or strokes. The main treatment consists of regular blood draws—essentially bloodletting—to keep the disease in check.
    • “But a new drug from Protagonist Therapeutics and Takeda can slow down a patient’s production of red blood cells and nearly eliminates the need for phlebotomies, new data show, potentially reducing patients’ fatigue and other consequences of routine blood draws.
    • “I think that this drug would really be groundbreaking for patients,” said Dr. Bart Scott, a professor at Fred Hutchinson Cancer Center in Seattle, who treats patients with polycythemia vera and had some who enrolled in the drugmakers’ trial. “The time for leeches is over.” * * *
    • “The 52-week [trial] data is expected around the spring of 2026, and Takeda plans to file for Food and Drug Administration approval after that, said Dr. Phuong Khanh Morrow, head of the oncology therapeutic area at Takeda.”
  • Per BioPharma Dive,
    • “An experimental cholesterol-lowering pill from Merck & Co. succeeded in a pair of late-stage studies, the company said Monday [June 9, 2025].
    • “In one study, Merck’s drug, enlicitide, was tested against a placebo in people already taking statins and who have either an inherited condition that causes high cholesterol or are at risk of atherosclerosis. The second trial evaluated enlicitide against other oral therapies, such as ezetimibe, in people on statins and with abnormally high levels of fats in the blood.
    • “Merck didn’t provide specifics but said in both cases enlicitide met all of its study objectives and demonstrated “statistically significant and clinically meaningful reductions” in LDL-C, or “bad” cholesterol, without any important differences in the number of adverse events. Details will be presented at a future medical meeting. Company shares climbed 2% in early trading Monday.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “The healthcare industry added 62,000 jobs in May, exceeding the sector’s average monthly gain of 44,000 workers over the past year, according to a new report from the U.S. Bureau of Labor Statistics released Friday [June 6, 2025]. 
    • “Employers added 30,000 hospital jobs, 29,000 ambulatory healthcare services roles and 6,000 skilled nursing positions last month, according to the report. 
    • “The monthly jobs data demonstrates continued strong demand for healthcare workers, despite broader economic uncertainty and reports of some health systems freezing hiring or implementing layoffs.”
  • Beckers Payer Issues notes, “Many insurers are asking for double-digit rate increases in 2026 for the individual and small group exchange markets as they face a potential expiration of enhanced premium tax credits and rising costs.”
  • Modern Healthcare reports,
    • “Dr. Bobby Mukkamala’s is tapping into decades of medical experience, as well as his recent time as a patient with a brain tumor, as he begins his one-year term as American Medical Association president.
    • “Healthcare runs in the family. His father is a retired radiologist, his mother a retired pediatrician and his wife is a obstetrician-gynecologist.
    • “In an interview, the Flint, Michigan-based otolaryngologist said he plans to focus on physician shortages related to burnout and the uptick in non-physician caregivers. He also plans to address the hoops most patients have to jump through to receive adequate care, an experience made clear to him late last year when he was diagnosed with a brain tumor. Most of the tumor was removed in surgery and he is receiving treatment for the residual 10%.”
  • Beckers Hospital Review informs us,
    • Detroit-based Henry Ford Health recorded an operating income of $77.5 million (2.4% operating margin) in the first quarter of 2025, down from an operating income of $98.5 million (4.5% margin) during the same quarter in 2024, according to its May 28 financial report.  
  • and
    • Pittsburgh-based Allegheny Health Network recorded an operating income of $7.7 million (0.6% operating margin) in the first quarter of 2025, up from an operating loss of $31.3 million (-2.5% margin) during the same period last year, according to its May 29 financial report. 
  • and also
    • lists “seven drug new shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 

Friday report

David Ermer–AHRQ, CDC, Congress, COVID-19, Employee Wellness Programs, FDA, Medical / Rx research, Mental health care, OPM, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The American Hospital Association (AHA) News reports,
    • “Sens. Chuck Schumer, D-N.Y., Susan Collins, R-Maine, and Andy Kim, D-N.J., June 5 reintroduced the SEPSIS Act, legislation which would task the Centers for Disease Control and Prevention with continuing its efforts addressing sepsis care. The agency’s work would include an education campaign about addressing sepsis in hospitals, improving pediatric sepsis data collection, sharing information with the Department of Health and Human Services on data collection, and developing and implementing a sepsis outcome measure.
    • “The bill would also require a report on a sepsis outcome measure and a congressional briefing on the CDC’s sepsis activities. Additionally, the legislation includes a voluntary recognition program for hospitals that maintain effective sepsis programs or improve their programs over time.”
  • and
    • “The House June 4 passed the AHA-supported SUPPORT Act (H.R. 2483) by a 366-57 vote. The legislation reauthorizes key prevention, treatment and recovery programs for patients with substance use disorder, including programs to support the behavioral health workforce.”
  • Federal News Network tells us,
    • “More federal employees filed retirement papers with the Office of Personnel Management in May than in the last three months. OPM said it received more than 15,000 claims last month, driving the backlog up over 21,000. The processing time for these retirement claims remain consistent at 49 days on average in May and 52 days on average for the entire 2025. The increase in applications comes as OPM is requiring agencies to send retirement paperwork only in digital formats by July 15. OPM launched two new tools this week to improve the retirement services process. One is a new platform for agency HR and payroll providers and another to modernize the Electronic Official Personnel Folder (eOPF) platform.”
  • CMS shared “Federal Independent Dispute Resolution (IDR) Technical Assistance for Certified IDR Entities and Disputing Parties –June 2025 — Topic: Errors Identified After Dispute Closure.”
  • BenefitFocus discusses “Health Care Transparency 2.0 – What Might We See in Forthcoming Transparency Regulations.”

From the Food and Drug Administration front,

  • Per BioPharma Dive, “FDA meeting gives window into gene therapy field’s angst. Gene therapy experts and advocates warning of the sector’s many challenges found a receptive audience in FDA leadership at a regulatory forum Thursday.”
  • Per MedTech Dive,
    • “Medtronic is recalling certain tracheostomy tubes because of the risk that the devices could dislodge, causing an emergency where the patient cannot breathe or their airway is blocked, according to a Thursday Class I recall notice from the Food and Drug Administration. 
    • “The company sent a notice to customers on Feb. 26 asking them to quarantine and return all unused tubes from the affected lot. The recall applies to the Shiley adult flexible tracheostomy tube with taperguard cuff reusable inner cannula.
    • “Medtronic began the recall after receiving reports from customers that the flange used to secure the device may become disconnected. Patient harm was reported in some cases, but no deaths have been reported to date, a company spokesperson wrote in an email Thursday.”
  • BioPharma Dive relates,
    • “Vera Therapeutics lost nearly a third of its market value Friday after Otsuka Pharmaceutical presented late-stage study data on a rival drug it’s developing for the kidney disease IgA nephropathy. At a medical meeting, Otsuka said its therapy, sibeprenlimab, led to a 51% reduction in proteinuria, a key marker of kidney health, after nine months of treatment. Though cross-trial comparisons can be misleading, Vera’s therapy led to a 42% reduction in proteinuria compared to placebo at a similar timepoint in its own Phase 3 study, causing investors to sell off company shares. Still, some analysts defended Vera. Jefferies’ Farzin Haque cautioned not to “overinterpret the data” and argued the two datasets “are not clinically or statistically different for commercial uptake.” The Food and Drug Administration could approve Otsuka’s drug by Nov. 28. On Monday, Vera said it intends to file an accelerated approval application in the fourth quarter.”

From the judicial front,

  • Beckers Hospital Review informs us,
    • “The CEO of a healthcare software company was convicted by a federal jury for his role in operating a platform that generated fraudulent physicians’ orders to defraud Medicare and other payers out of more than $1 billion.
    • “Gary Cox, 79, of Maricopa County, Ariz., was the CEO of Power Mobility Doctor Rx (DMERx), an internet-based platform that generated fraudulent orders for unnecessary orthotic braces, pain creams and other items, according to a June 3 Justice Department news release.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • Seasonal influenza, COVID-19, and RSV activity is low.
    • COVID-19
      • COVID-19 wastewater activity is low and emergency department visits and laboratory percent positivity are at very low levels.
    • Influenza
    • RSV
      • RSV activity has declined to low levels.
  • The AHA News lets us know,
    • “There have been 1,168 confirmed cases of measles across 33 states as of June 6 this year, according to the latest data from the Centers for Disease Control and Prevention. This year’s figure is more than four times higher than the 2024 total of 285 cases. There have been 17 outbreaks this year, and 89% of confirmed cases (1,040 of 1,168) are outbreak-associated. The vaccination status of 95% of all cases is classified as “unvaccinated or unknown.” 
  • Of note, Health Day warns us,
    • “An afternoon snooze might seem appealing to middle-aged folks and seniors, but these naps could carry a high cost.
    • “People with certain types of napping patterns have a greater risk of an early death, researchers are slated to report at an upcoming meeting of the American Academy of Sleep Medicine (AASM).
    • “People who slept longer during the day, had irregular daytime sleep patterns, or slept more around midday and early afternoon were at greater risk, even after accounting for health and lifestyle factors,” lead researcher Chenlu Gao, a postdoctoral research fellow at Massachusetts General Hospital in Boston, said in a news release.
    • “The findings call into question the whole concept of the “power nap.”
  • HHS’s AHRQ posted a report about “Management of Suicidal Thoughts and Behaviors in Youth: A Systematic Review.”
  • Per HR Dive,
    • “Work can either fuel employee well-being or become a source of strain for employees already stressed out by economic volatility and political tension, according to a May 12 survey of employee mental health by Inmar Intelligence.
    • “Of the 1,000 U.S. full- and part-time employees who responded to the May 12 survey, 34% said their job positively impacts their mental health, while 33% reported a negative impact, Inmar found.
    • “This near-even split reinforces the importance of thoughtful leadership and inclusive workplace design to support the full spectrum of employee needs,” the business technology firm stated in a May 29 post.”
  • Cardiovascular Business reports,
    • “Heart surgeons with the WVU Heart and Vascular Institute have made a bit of history, performing the world’s first robotic explant of a transcatheter aortic valve replacement (TAVR) device and subsequent aortic valve replacement.
    • “The group already has plenty of experience breaking new ground in the field of robotic-assisted surgery. They developed a robotic aortic valve replacement (RAVR) technique that is now being used all over the world and performed the world’s first robotic aortic valve replacement and coronary artery bypass (RAVCAB) procedure in 2024.
    • “This latest breakthrough started when Thelma Hyer, a 67-year-old female patient, presented with a failing TAVR valve in addition a leaky mitral valve. She had received her TAVR valve just four years prior, but premature structural valve degeneration had already made a full replacement necessary.
    • “Vinay Badhwar, MD, executive chair of the WVU Heart and Vascular Institute, initially recommended open-heart surgery to remove the failing TAVR valve and then replace her aortic and mitral valves. However, Hyer and her family had hesitations due to her history of scoliosis and arthritis. Badhwar then proposed using robotics as an alternative. 
    • “The technology had never been used in this exact way before, but Badhwar was confident in the abilities of both his team and the robotic surgery platform. The group developed a plan, talked it over with the patient, and went forward with the robotic procedure in late May. 
    • “The operation—including the TAVR explant and the replacement of both heart valves—appears to have been a success. Hyer was discharged after less than a full week of observation.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Omada Health shares jumped after the company made its public-market debut, propelled by Americans’ renewed focus on how weight affects physical health.
    • “Shares of the virtual healthcare platform climbed 35% to $25 on Friday, at one point hitting a high of $28, above the initial offering price of $19. The price gives it a market valuation of around $1.4 billion.
    • “The gains are a sign investors are willing to invest in newly public companies after a volatile stock market pushed some companies like payments platform Klarna to delay its IPO filing. Stablecoin issuer Circle opened on Thursday at $69, more than double its offering price, and was recently trading at $119.15. Hinge Health HNGE 0.83%increase; green up pointing triangle, another digital health company, opened in May at $39 after offering a $32 price.
    • “Omada is trading publicly after 14 years of providing support to patients with weight-related chronic illnesses. Leadership sees the current moment as the perfect time for an IPO, as GLP-1 drugs such as Ozempic, Wegovy and Mounjaro have sparked renewed focus on health problems that can stem from obesity, President Wei-Li Shao said.
    • “We’re entering this unique moment in time where there’s a convergence between what we’ve been working on for over a decade, and then also what society is increasingly caring about,” Shao said.”
  • Becker Hospital Review discusses ten key transactions that created Ascension 2.0.
    • “Over the last 16 months, St. Louis-based Ascension has sold or consolidated about 35 hospitals across the country as it revamps its hospital portfolio, operating model and overall financial performance.
    • “Despite reporting a $466 million operating loss (a -2.4% margin) for the nine months ending March 31, 2025, the Catholic nonprofit system has made notable strides in improving its liquidity position. That progress is largely attributed to the successful collection of accounts receivable that had temporarily spiked due to two major cybersecurity incidents — the May 2024 ransomware attack and the February 2024 Change Healthcare cyberattack.
    • “Since the fourth quarter of fiscal 2024 — the three months ending June 30, 2024 — Ascension has improved recurring operating performance by $1.4 billion, while increasing patient volumes and same-facility revenue.”
  • Beckers Health IT tells us,
    • “California-based Stanford Health Care is piloting an internally developed, AI-backed software designed to revolutionize clinician interaction with the EHR.
    • “Nigam Shah, MBBS, PhD, chief data science officer at Stanford Health Care, is leading the development team for ChatEHR, which allows clinicians to ask questions, request summaries and pull specific information from a patient’s medical record. ChatEHR is built directly into Stanford’s EHR to maximize clinical workflow.
    • “The pilot is available to a small cohort of 33 physicians, nurses and physician assistants. The technology is secure and designed for information gathering; not medical advice.
    • “ChatEHR, which has been in development since 2023, facilitates a more streamlined and efficient way for clinicians to interact with patient records.
    • “This is a unique instance of integrating [large language model] capabilities directly into clinicians’ practice and workflow,” said Michael Pfeffer, MD, chief information and digital officer at Stanford Health Care and School of Medicine, in a news release. “We’re thrilled to bring this to the workforce at Stanford Health Care.”
  • Drug Store News informs us,
    • “Walmart has become the first retailer to scale its drone delivery to five states with its recently announced service expansion in Atlanta, Charlotte, Houston, Orlando and Tampa. The new service will launch at 100 stores throughout Arkansas, Florida, Georgia, North Carolina and Texas, in addition to current operations in Northwest Arkansas and the Dallas-Fort Worth area.
    • “As we look ahead, drone delivery will remain a key part of our commitment to redefining retail,” said Greg Cathey, SVP, Walmart U.S. transformation and innovation. “We’re pushing the boundaries of convenience to better serve our customers, making shopping faster and easier than ever before.”
    • “Continued Cathey: “This expansion of our drone delivery service marks a significant milestone in that journey. As the first retailer to scale drone delivery, Walmart is once again demonstrating its commitment to leveraging technology to enhance our delivery offerings with a focus on speed.” 

Midweek Report

David Ermer–Congress, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, NIH, Obesity, Rx coverage, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

From Washington, DC

  • The American Hospital Association News tells us,
    • “A Congressional Budget Office report released June 4 found that enactment of the fiscal year 2025 budget reconciliation bill, the One Big Beautiful Bill Act (H.R. 1), would lead to 10.9 million people becoming uninsured in 2034 due to significant changes to the Medicaid program and Affordable Care Act coverage. A follow-up letter from the CBO provides more detail on how these changes would impact the number of uninsured. The CBO also estimated that the bill would lower gross benchmark premiums for marketplace plans under the ACA by an average of 12.2%.”
  • Per a Senate news release,
    • On Wednesday, June 11, 2025, at 10:15 am the Senate Judiciary Committee will hold a hearing titled “23 and You, the Privacy and National Security Implications of the 23 and Me Bankruptcy.”
  • STAT News reports,
    • In a boost for Merck, a U.S. Patent and Trademark Office panel agreed to reconsider a patent granted to another company that could affect plans to broaden use of its franchise product, the Keytruda cancer treatment.
    • “The dispute with Halozyme Therapeutics occurs as Merck plans to sell a new injectable version of Keytruda that the company is betting will sustain a medicine that has accounted for nearly half of its sales. Patent protection for the treatment, which is currently administered intravenously and generated $29.5 billion in revenue last year, lapses in 2028.
    • “At issue before the PTO are certain enzymes called Mdase that Halozyme developed to enable the administration of drugs by injection. Last November, Merck petitioned the PTO to reconsider seven patents that were awarded to Halozyme, arguing they were overly broad and should not have been granted. The filing came a few months after the PTO granted one patent in particular.
    • “Patent challenges are almost a daily feature of behind-the-scenes jockeying in the pharmaceutical industry, but the battle over Keytruda is more closely watched than most since the stakes are so high for Merck. In March, the company asked the Food and Drug Administration to approve the injectable version, which would cut treatment time in half, and a decision is expected in September.”
  • Per an HHS new release,
    • “The U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announces the appointment of Paula M. Stannard as Director of the Office for Civil Rights. In this role, Director Stannard is the Department’s chief officer and adviser to Secretary Robert F. Kennedy, Jr. concerning the implementation, compliance, and enforcement of Federal health information privacy, security, and breach notification rules under the Health Insurance Portability and Accountability Act (HIPAA) as well as Federal civil rights, conscience, and religious freedom laws in HHS’ jurisdiction.
    • “I’m proud to welcome Paula back to HHS,” said Secretary Robert F. Kennedy, Jr. “She’s a proven public servant who delivered results during her time at HHS under both President Trump and President George W. Bush. Paula brings deep institutional knowledge, relentless focus, and an unwavering commitment to civil rights. Under her leadership, the Office for Civil Rights will drive forward President Trump’s bold civil rights agenda with clarity, energy, and purpose.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “Moderna Inc. has agreed to do a placebo-controlled trial of its new Covid vaccine that was recently approved by US regulators, Health and Human Services Secretary Robert F. Kennedy Jr. said Tuesday.
    • “In a post on X, Kennedy said he wanted to “address those of you who have anxieties” about the Food and Drug Administration’s limited approval of Moderna’s vaccine, which was cleared for a narrower segment of the population than prior shots. 
    • “Moderna declined to comment. As a condition for approving the new shot, the FDA required a future placebo-controlled study in adults ages 50 to 64 without high-risk conditions, according to agency documents.
    • “Kennedy said that “the FDA will monitor and collect data throughout the trial for every adverse outcome” and “scrutinize every aspect of the trial.”
  • Per a press release,
    • Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—announced today FDA clearance of its most significant technological advancement to date. The clearance includes an entirely new portable MRI scanner powered by the proprietary Optive AI™ software. This new system delivers the highest level of image quality, functionality, and usability to date, unlocking a new brain imaging paradigm for clinicians and their patients.
  • Per FiercePharma,
    • “Bayer has taken another step toward achieving its €3 billion peak sales estimate for androgen receptor inhibitor Nubeqa, scoring an FDA approval to expand its use to all patients with metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC).
    • “The label expansion comes three years after the FDA signed off on Nubeqa in combination with androgen deprivation therapy (ADT) and the chemotherapy docetaxel to treat patients with mCSPC. The new nod allows Nubeqa to be used along with ADT by those who can’t tolerate chemo.
    • “The FDA endorsement was based on results of a phase 3 trial, ARANOTE, which showed that Nubeqa significantly extended the time before tumor progression or death in patients with mCSPC compared with ADT alone. In the study of 669 patients who were randomized 2 to 1 to receive 600 mg of Nubeqa plus ADT or placebo plus ADT, Nubeqa reduced the risk of radiographic progression or death (rPFS) by 46%, allowing the trial to achieve its primary endpoint.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration has awarded Sarepta Therapeutics a new kind of fast pass that could help speed the reviews of certain gene therapy applications it brings to the regulator in the future.
    • “The so-called platform technology designation issued to Sarepta is meant to streamline the development and evaluation process for gene therapies using a specific delivery tool, a viral vector dubbed rAAVrh74. That component is part of multiple Sarepta programs, among them the already approved Duchenne muscular dystrophy gene therapy Elevidys.
    • “According to Sarepta, the designation is one of the first given to a drug program since the initiative was launched by the FDA. It enables Sarepta to use evidence previously gathered from studies involving the vector in future applications, though differences in how some of its newer gene therapies are manufactured may limit its usefulness.”
  • Per MedTech Dive,
    • “Smiths Medical has recalled infusion pumps to update the instructions to address three problems that could lead to serious injury or death. The devices are staying on the market. 
    • “The Food and Drug Administration, which published Class I notices about the recalls Tuesday, said issues with some CADD-Solis Ambulatory Infusion Pumps and CADD-Solis VIP Ambulatory Infusion Pumps could interrupt or delay treatment. Smiths has not reported any serious injuries or deaths related to the issues, but the FDA sees a risk of harm.” 

From the public health and medical research front,

  • STAT News reports,
    • “KJ Muldoon, the first infant treated with a personalized gene-editing drug, has been discharged from the hospital for the first time in his life, the Children’s Hospital of Philadelphia announced Tuesday. After 307 days at CHOP, KJ was dressed in what early studies suggest are the world’s smallest and cutest graduation cap-and-gown before leaving.
    • “It’s a promising sign for KJ, his family, and the therapy researchers built in just 6 months. Born with an ultra-rare disease that prevented his liver from breaking down ammonia, he was rushed to CHOP, where specialists kept him under strict monitoring to prevent ammonia from flaring and doing long-term damage. Typically, he would receive a liver transplant. Instead, scientists across the country teamed to devise a gene-editing treatment.
    • “KJ received the first of three doses at six months old. He’s now 10 months old. The hope is that, while not cured, he has been left with a far more mild version of his disease. Meanwhile, researchers are working on ways to scale his treatment for thousands of others.”
  • and
    • “Circulating tumor DNA blood tests are rapidly gaining popularity among oncologists for their potential to detect cancer recurrence and treatment resistance earlier than traditional imaging. But despite their promise, data presented at the annual ASCO meeting this week suggest that the clinical value of ctDNA tests is still unproven.
    • “While some trials hint at benefits, others lack conclusive survival outcomes — which raises concern about whether early interventions based on ctDNA actually improve patients’ lives.
    • “We need evidence to know the true value of these tests,” University of Pennsylvania cancer researcher Angela DeMichelle told STAT’s Angus Chen. “They have incredible potential to help people, but if we don’t do the studies and don’t do them the right way, we can hurt people.”
  • The American Journal of Managed Care adds,
    • A blood-based circulating tumor DNA (ctDNA) test detected colorectal cancer (CRC) with 79.2% sensitivity and 91.5% specificity, according to a recent prospective study. These findings suggest the investigational test may be a viable noninvasive screening option, although its ability to detect advanced precancerous lesions remains limited.
    • The population-based, observational study is published in JAMA.
    • “This study was designed as a large, prospective diagnostic accuracy evaluation of a blood-based CRC screening test, with blinded comparison to colonoscopy in an average-risk screening population,” wrote the researchers of the study. “It enrolled a geographically and demographically diverse cohort across 201 sites, approximating the racial and ethnic distribution of the US.”
    • “CRC is the second leading cause of cancer-related deaths globally, with more than 1.9 million new cases and 930,000 deaths estimated in 2020 alone. Increased access to screening options—including stool-based tests, visual exams, and emerging blood-based tests—can help detect CRC at its most treatable stages and reduce both incidence and mortality.”
  • Per Reuters,
    • “American teens are increasingly turning to the weight-loss drug Wegovy as more families and their doctors gain confidence in its use for young people with obesity, new data shared with Reuters shows.
    • “The average rate of teens beginning treatment with the highly effective Novo Nordisk (NOVOb.CO), opens new tab drug grew 50% last year to 14.8 prescriptions per 100,000 adolescents, according to an analysis by health data firm Truveta.”
  • Per Healio,
    • “Enrollment in a patient-delivered intervention allowed adults with overweight or obesity to better maintain weight loss than those receiving standard of care, according to trial findings published in JAMA Internal Medicine.
    • “In the CHAMPS randomized controlled trial, adults with overweight or obesity who previously lost at least 5% of their body weight with lifestyle intervention were randomly assigned to a weight-loss maintenance intervention led by fellow patients who previously lost weight or to standard of care weight maintenance led by a physician. Adults participating in the patient-led intervention were more successful at maintaining their body weight.”
  • Medscape notes,
    • “As part of treating the overall well-being of your patients, it may be beneficial to recommend nutritional counseling. More insurance carriers are providing this service as a benefit.
    • “When patients have conditions such as type 2 diabetes, high blood pressure, heart disease or obesity, suggesting nutritional counseling could help your patients become more informed about making healthier choices. More health insurance plans cover nutritional counseling, although some may only provide coverage for specific conditions.
    • “Integrating nutritional counseling into routine clinical practice is essential and necessary to achieving optimal health outcomes,” said Scott Isaacs, MD, adjunct assistant professor of medicine, Emory University, and president of the American Association of Clinical Endocrinology, who is based in Atlanta. “By ensuring that nutritional counseling is accessible, personalized, and supported by insurance, we empower our patients to prevent disease, effectively manage chronic conditions, and improve both quality of live and longevity.”
  • The Wall Street Journal reports,
    • “New research is helping to answer an important question about ultra-processed foods: Which ones might be healthier? 
    • “One reason many ultra–processed foods often lead us to eat big meals and heavy snacks is because of their texture, which makes them go down easily and quickly, according to a new study presented this week at a conference in Orlando, Fla., of the American Society for Nutrition.
    • “But some diets filled with ultra-processed foods don’t cause us to eat as much. People in the study who had a diet of slower-to-eat ultra-processed foods such as crunchy breakfast cereal and multigrain buns consumed an average of 369 fewer calories a day than when they were eating quick-to-eat ultra-processed foods such as commercially made smoothies and soft breads.
    • “Meals that are equally satisfying were eaten in different ways purely as a function of the way they’re textured,” said Ciarán Forde, a professor at Wageningen University in the Netherlands, who led the study.”
  • Per an NIH press release,
    • Researchers at the National Institutes of Health (NIH) have identified which brain circuits are vital for visual acuity and how they are affected by damaged retinal cells. While vision restoration therapies, such as stem-cell and gene therapies, aim to replace or repair damaged cells in the eye, it is critical to understand how brain circuits involved in vision are affected by retinal cell loss. Study results suggest that targeting these circuits may be necessary to achieve optimal recovery of visual function, and have significant implications for the development of future vision restoration therapies that address visual pathways beyond the retina. The study published today in The Journal of Neuroscience.
    • “A huge amount of progress has been made in repairing the eye, however little attention has been paid to the functional consequences beyond the eye,” said the study’s lead investigator, Farran Briggs, Ph.D., senior investigator at NIH’s National Eye Institute (NEI). “Brain circuits downstream of damaged or dying retinal cells in the eye may also undergo some loss of function following changes to their retinal inputs.”

From the U.S. healthcare business front,

  • Beckers Health IT lets us know about six things concerning “CVS Health’s $20B bet on integrated, tech-enabled care,” and five details about Mark Cuban’s pharmacy network.
  • Modern Healthcare reports,
    • “Despite tight budgets and other operational challenges, health systems are increasingly investing in replacement hospitals and sustainability, while maintaining a strong focus on outpatient facilities in construction and design projects.
    • “More than 53% of the construction and design firms that responded to Modern Healthcare’s 2025 Construction and Design Survey said the industry is growing, even as it faces financial headwinds such as funding limitations, inflation and recent tariffs.”
  • Per BioPharma Dive,
    • “Looking to defend its giant cardiometabolic health franchise, Eli Lilly is licensing a technology from Swedish biotechnology firm Camurus that promises to produce longer-acting medications.
    • “Camurus’ FluidCrystal technology is designed to methodically release a therapeutic drug substance into the body over a period of days or months. After an injection, the solution interacts with bodily fluids to transform into a liquid crystalline gel. The gel holds the active ingredient and then slowly degrades, releasing medicine.
    • “The deal includes an unspecified upfront payment as part of an initial package that may be worth as much as $290 million, Camurus said Tuesday. That figure also includes payments for reaching certain development and regulatory milestones. Another $580 million could be available for meeting sales goals, along with mid-single digit royalties for successful products.”
  • BioPharma Dive summarizes its reporters’ takeaways from the ASCO conference which ended yesterday.
  • Fierce Healthcare relates,
    • “DispatchHealth and Medically Home closed their merger deal on Wednesday, combining the forces of at-home care and hospital-at-home leaders.   
    • “Operating under the DispatchHealth brand, the combined company will provide three core service lines. Its hospital-alternative care service, also called hospital at home, provides inpatient hospital-level care at home. The company also provides emergency-level care, when appropriate, to help patients avoid ED visits. 
    • “The merger was announced in mid-March. In the coming months, the company will integrate Medically Home’s technology platform and clinical command center for use nationwide, the company said.
    • “The two leadership teams have combined. Jennifer Webster will continue as the CEO of DispatchHealth. Graham Barnes, who took over as CEO of Medically Home in August 2024, is departing to pursue new opportunities. Pippa Shulman, D.O., has assumed the role of chief medical officer, according to a press release.”