Tuesday report

COVID-19 vaccine

Tuesday report

David Ermer–CMS, Congress, COVID-19 vaccine, Employee Wellness Programs, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “The Trump administration released its ‘Make America Healthy Again’ strategy to improve children’s health.
    • “The strategy includes a vaccine framework, lenient approach to pesticides, and focus on processed foods and dyes.
    • “The FDA will modernize infant-formula nutrient requirements and increase testing for heavy metals and other contaminants.”
  • and
    • “President Trump signed an executive order to increase federal enforcement of pharmaceutical advertisements.
    • “The FDA is sending thousands of enforcement letters to drugmakers regarding misleading advertisements on multiple platforms.
    • “HHS wants to amend FDA guidance, closing a loophole allowing abbreviated descriptions of drug side effects in TV ads.”
  • Per a Congressional news release,
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, announced that the HELP Committee will hold a hearing next week on delivering President Trump’s mission to restore radical transparency at the Centers for Disease Control and Prevention (CDC). This is crucial to protecting the health of American children.
    • “At the hearing, the HELP Committee will hear from former CDC officials Susan Monarez, PhD, and Debra Houry, M.D., about the recent high-profile departures from the agency. The Committee is also planning to invite current officials at the Department of Health and Human Services to respond by speaking with Committee members at a future hearing.”
  • STAT News tells us,
    • “More than 160 U.S. lawmakers have urged the Trump administration to abandon a newly announced pilot program that would allow pharmaceutical companies to offer rebates for a small number of therapies to hospitals that participate in a federal drug discount program.
    • “At issue is the 340B discount program, which was created to help hospitals and clinics care for low-income and rural patients. Drug companies that want to take part in Medicare or Medicaid must offer their medicines at a discount — typically, 25% to 50%, but sometimes higher — to participating hospitals and clinics. Right now, drug companies generally provide the discounts at the time of purchase.” * * *
    • “The latest controversy has been over double discounts, an issue that can be traced, in part, to the Inflation Reduction Act, which allows Medicare to negotiate the prices of some drugs. The concern is a significant issue for drugmakers, since certain medicines, including big-selling heart and cancer treatments, have been selected by Medicare for price negotiations.
    • “The Inflation Reduction Act imposes a maximum fair price on drugs paid for by Medicare and obligates the companies to pay added inflation rebates in Medicare. But the requirement overlaps with 340B, because drugmakers must offer hospitals the lower of the maximum fair price or 340B price, and pay inflation rebates only on drugs not sold at the 340B price.”
  • The American Hospital Association is opposed to the rebate pilot.
    • “The AHA Sept. 8 urged the Federal Trade Commission and Antitrust Division of the Department of Justice to investigate several drug companies’ concerted efforts to impose rebate models within the 340B Drug Pricing Program, saying the actions may violate antitrust laws. 
    • “These drug companies sought to switch from providing ‘upfront discounts’ on 340B drugs to a model in which 340B hospitals must purchase even the costliest drugs at full price and then submit for a rebate,” AHA wrote. “If successful, this concerted effort would essentially obligate America’s safety-net hospitals to advance interest-free loans to the world’s largest and most profitable drug companies. This new ‘rebate model’ would inflict untold harm on hospitals, patients and communities. And for your purposes, the publicly available information suggests potential anticompetitive activity.”  
    • “The AHA letter details a timeline of many actions taken by several drug companies over a six-month period highlighting a potential antitrust conspiracy to limit 340B discounts.”
  • STAT News also informs us,
    • “Medicare is delaying implementation of a Biden-era rule that would have made Medicare Advantage plans notify members about their unused supplemental benefits — services such as vision and dental. 
    • “Medicare didn’t say how long it’s delaying implementation but disclosed in a notice late Monday that insurers had asked questions and sought technical guidance on the rule. The agency said it’s delaying implementation “for contract year 2026 and beyond” because of “logistical concerns.” 
  • Per a Government Accountability Office news release,
    • “When Medicare beneficiaries need medical devices or health care services, they can choose from among the items and services that Medicare has decided to cover. 
    • “Medicare sets time frames for determining coverage and meets its goals more than 80% of the time. However, the agency doesn’t systematically identify the reasons why some decisions are delayed, which may make it harder to improve timeliness.
    • ‘There are also concerns that Medicare isn’t transparent about how it prioritizes reviews of new coverage requests. Making this information available could improve the quality of requests.
    • “Our recommendations address these issues.”
    • Here is a link to the full report.
  • Federal News Network points out,
    • “Federal employees, on average, are waiting longer to see their retirement applications processed. New data from the Office of Personnel Management for August shows it takes an average of 70 days to process a claim from a retiring fed. But if retirement claims are coming to OPM in less than 60 days, those cases take on average 45 days to complete. At the same time, OPM received more than 9,400 retirement claims last month. OPM’s backlog of retirement claims dropped by 2,000 to 24,300.” 
  • Per MedTech Dive,
    • “Microbot Medical has received 510(k) clearance for its Liberty Endovascular Robotic System, the company said Monday.
    • “The Food and Drug Administration clearance positions Microbot to start marketing the single use, remotely operated robotic system for peripheral endovascular procedures.
    • “Siemens Healthineers launched a robotic system for peripheral vascular interventions in 2021 but withdrew from the market to focus on neurovascular procedures two years later.”

From the public health and medical/Rx research front,

  • The Washington Post reports,
    • “‘Kissing bug’ disease is now endemic in the [southern] U.S., CDC says. What is it?
    • “The U.S. is seeing a rise in Chagas disease, which is a life-threatening illness transmitted through “kissing bugs” known to bite human faces. Pets can be carriers.”
  • MedPage Today tells us,
    • “The monoclonal antibody romosozumab (Evenity) increased bone mineral density (BMD) in premenopausal women with idiopathic osteoporosis, according to a small, phase II open-label study.
    • “Among the 29 women enrolled, treatment with romosozumab was associated with a 15% gain in BMD in the lumbar spine, a 5.3% increase at the total hip, and a 5.4% increase at the femoral neck as measured by dual-energy x-ray absorptiometry at 1 year (all P<0.001), reported Lauren Lynch, MD, PhD, of Columbia University Irving Medical Center in New York City.”
    • “Increases in BMD at all three spots were significant by month 6 of treatment, she said at the American Society for Bone and Mineral Researchopens in a new tab or window annual meeting.
    • “Treatment with romosozumab was also tied to a 3.4% gain in trabecular bone score at 1 year (P<0.001).
    • “These promising data provide support for future randomized controlled trials that test romosozumab as a therapeutic option for premenopausal idiopathic osteoporosis,” said Lynch.”
  • Per Healio,
    • “Body composition measurements may be better predictors of colorectal cancer incidence than BMI.
    • “An evaluation of more than 9,000 postmenopausal women who had dual-energy X-ray absorptiometry-determined adiposity found those with higher visceral adipose tissue and android fat had greater risk for developing the malignancy. Those with increased subcutaneous adipose tissue, more closely related to BMI, did not.”
  • and
    • “The prevalence of mild, moderate and severe obstructive sleep apnea in U.S. adults are each expected to rise by 2050, according to results published in The Lancet Respiratory Medicine.
    • “By projecting a rise in OSA prevalence, the research helps fill a critical gap in public health planning and ensures that health systems, payers and policymakers can prepare for rising demand,” Carlos M. Nunez, MD, chief medical officer at Resmed, told Healio.”
  • The International Foundation of Employee Benefit Plans lets us know,
    • “Many people could benefit from a nudge to help them exercise more, improve their finances or get a recommended health screening.
    • “A recent report from the International Foundation of Employee Benefit Plans suggests that organizations that provide motivation in the form of incentives tend to have better participation in their wellness programs, likely leading to improvement in several workforce measures.
    • “Workplace Wellness and Financial Education: 2025 Survey Report uncovers insights into the types of wellness incentives organizations offer and their impact on program participation as well as overall worker wellness and organizational goals.
    • “More than four in ten (44%) survey respondents said they offer an incentive for at least one of their wellness initiatives. In addition, 19% said incentives are offered through a vendor or health care provider. Thirty-eight percent said they do not offer incentives.” 
  • Beckers Hospital Review identifies the states that vaccinate their populations the most and those that vaccinate their populations the least based on a Wallet Hub report published Sept. 9.

From the U.S. healthcare business front,

  • The American Hospital Association reports
    • A JAMA internal medicine study published Sept. 8 found that since the COVID-19 pandemic, Medicare Advantage beneficiaries have been experiencing longer hospital stays than those under Traditional Medicare. The study examined more than 89 million hospitalizations from 2017 to 2023 and found the average length of stay for MA admissions during that period increased from 6 to 7.1 days, while Traditional Medicare admissions grew from 5.8 to 6.3 days. The researchers noted that these trends “may reflect insurance-related discharge barriers” and that the results “are consistent with hospital industry reports.” They point to prior authorization or limited post-acute care networks as possible causes. 
  • The Wall Street Journal informs us,
    • Novartis agreed to buy Tourmaline Bio in a roughly $1.4 billion-dollar deal that boosts its cardiovascular drug pipeline with access to the targeted therapy drug pacibekitug.
    • The Swiss pharmaceutical company said Tuesday that it would offer Tourmaline Bio shareholders $48 a share, valuing the company at approximately $1.4 billion on a fully diluted basis. Tourmaline’s board has approved the deal.
    • Tourmaline Bio [which is based in Massachusetts] is a clinical-stage biopharmaceutical company developing pacibekitug which is a treatment option for atherosclerotic cardiovascular disease.
  • Per STAT News,
    • “Eli Lilly has developed artificial intelligence models that can help predict the behavior of potential drug candidates, based on the data the drugmaker has collected over the last two decades and at the cost of more than a billion dollars. Now, it’s opening up some of those models to biotech companies that want to use them to jumpstart their science.
    • “The only catch? Lilly wants to use data from those other companies to improve its models.”
  • Modern Healthcare tells us,
    • “The vast majority of UnitedHealthcare Medicare Advantage members will be enrolled in policies with high quality scores next year, parent company UnitedHealth Group announced Tuesday.
    • “UnitedHealthcare anticipates that 78% of its Medicare Advantage enrollees in 2026 will have plans in contracts that earned at least four out of five stars under the Star Ratings quality measurement program. That compares with 71% this year.
    • “The performance is consistent with expectations. UnitedHealth Group wrote in a filing to the Securities and Exchange Commission. The company also reaffirmed its full-year adjusted earnings outlook of at least $16 per share on revenues of $445.5 billion-$448 billion.”
  • Per Healthcare Dive,
    • “Mayo Clinic plans to close six of its clinics in Minnesota by Dec. 10 and reduce services at its Albert Lea hospital, the nonprofit provider said Monday.
    • “The health system will shutter clinics in Belle Plaine, Caledonia, Montgomery, North Mankato, St. Peter, and Wells and stop offering elective surgeries and procedures in ophthalmology, gynecology, endoscopy, orthopedics and podiatry at the hospital and clinic in Albert Lea.
    • “Mayo said it is consolidating services in part to address lower patient volumes and staffing shortages. Consolidating services will help the system “strengthen rural health care delivery and ensure safe, high-quality and sustainable care for generations to come,” Mayo said.”
  • Fierce Pharma reports,
    • “Amid a yearslong wave of enthusiasm and uptake for Eli Lilly and Novo Nordisk’s blockbuster obesity medicines, the drugs have scored a strong endorsement from an independent U.S. cost watchdog.
    • “In a draft report (PDF), the Institute for Clinical and Economic Review (ICER) determined the drugs are “highly cost-effective” because of their ability to help patients lose weight, reduce metabolic risk factors and address obesity-related health complications. The group specifically looked at Novo’s injectable semaglutide at the 2.4-mg dose, Novo’s investigational oral semaglutide 25-mg dose and Lilly’s injectable 15-mg dose of tirzepatide.
    • “After reviewing the health benefits of the medicines, the cost watchdog said the drugs met the mark on “commonly used cost-effectiveness thresholds.”
    • “Because treatment with all three drugs results in substantial weight loss and improvement in metabolic risk factors, we have high certainty that all three drugs have substantial net health benefit over lifestyle modifications alone,” ICER reviewers said in the report.”
  • Per Fierce Healthcare,
    • “Hospitals’ operating margins continued to soften through July as volumes remained strong, but spending on supplies and drugs inched upward, according to Kaufman Hall’s latest monthly performance report.
    • “The firm’s operating margin index of nationwide hospitals was a median 1.7% across seven months when including health system allocations for the cost of shared services and 5.3% when excluding those. That’s a low point for 2025 but still above hospitals’ performance during the same period in 2024.
    • “Looking at July alone, the index showed a 2.6% median operating margin with health system allocations and 6.2% without. In June, those were 3.4% and 7%, respectively.
    • “While performance has generally been strong this year, profitability has decreased slightly over the past few months,” Erik Swanson, managing director and data and analytics group leader with Kaufman Hall, said in a release.”
  • and
    • “Telehealth GLP-1 company Remedy Meds, founded in 2024, announced its intent to acquire health tech unicorn Thirty Madison for $500 million in an all-stock deal. 
    • “The deal will create a larger, multibrand platform across women’s, men’s and metabolic health, executives said. The deal also positions Remedy Meds as a more competitive player in the direct-to-consumer health space, up against Hims & Hers and Ro. 
    • “Thirty Madison was valued at $1 billion in June 2021, launching it to unicorn status. In the years since, the company has completed several mergers and acquisitions, including with women’s-health-focused company Nurx. 
    • “Remedy Meds is a relative newcomer compared with the company it plans to buy, having only been founded in January 2024. Its founder Haris Memon founded and sold a home goods company called Miracle Brands in July 2023 before entering the healthcare market.”
  • Per MedTech Dive,
    • “Senseonics has struck a deal to retake control of the commercialization and distribution of its implantable continuous glucose monitors, the company said Wednesday.
    • “Ascensia Diabetes Care is currently the exclusive worldwide distributor of the Eversense devices. That will change at the start of 2026, when Senseonics will resume responsibility.
    • “BTIG analysts said in a note to investors that the move shows “Senseonics is doubling down on its view that the one-year sensor will finally enable an inflection in patient demand for the implantable glucose monitor.”

Friday report

David Ermer–ACA, CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • This week’s blog post from OPM Director Scott Kupor concerns the value of incentives.
    • “Charlie Munger wasn’t talking about the federal General Schedule (GS) pay scale when he addressed a 1995 Harvard crowd on the critical role that incentives play in driving employee behavior, but he may as well have been. Because, unfortunately, 30 years later, his premonition remains true: how we pay federal employees remains one of the most critical – and backward – drivers of employee behavior.”
  • Bloomberg Law tells us,
    • “The Trump administration is rewriting the playbook for government hiring, allowing managers to select from a broader list of qualified candidates instead of having to choose from the top three scorers on a competitive exam.
    • “The new rule replaces the “rule of three,” under which civil service examiners narrow down a list of qualified applicants for a position while still giving the president and other senior officials the final say.
    • “The change will give hiring managers more latitude on which job candidates they exclude, allowing them to eliminate applicants if they’re passed over more than three times for the same position.’
  • Federal News Network informs us,
    • “Just three federal agencies, when combined, make up more than half of the total federal workforce reductions that have occurred so far under the Trump administration.
    • “The departments of Defense, Treasury and Agriculture have cut their staffing levels this year by a cumulative total of about 106,000 employees, according to data compiled by the non-profit Partnership for Public Service. That’s out of an estimated 199,000 federal employees governmentwide who have left their jobs since January, either voluntarily or by force.
    • “In terms of scale, the Defense Department has lost the most at 55,000 employees. The Treasury Department follows just after DoD with a loss of 30,000 employees — mostly from the IRS. And the Agriculture Department has 21,000 fewer employees, the Partnership found in its data report, which compiles findings from agency documents and media reports.”
  • Govexec considers how yesterday’s semi-annual regulatory agenda could impact federal employees.
  • STAT News reports,
    • “The Food and Drug Administration is now publishing complete response letters to drugmakers shortly after they are issued, marking a major shift in transparency into regulation by the agency. Yesterday, the FDA disclosed 89 previously unreleased CRLs from 2024 and 2025, including rejections for Replimune, Capricor Therapeutics, and Ultragenyx.
    • “Traditionally, it’s been up to companies to disclose the reasons for an FDA rejection, a process that critics contend can lead drugmakers to misrepresent what the agency said. In July, the agency announced its intention to release letters in “real time,” and published a batch of letters for drugs that had eventually won approval. Yesterday’s release went beyond that.”
  • The FDA adds, “Decision letters are accessible to the public as a centralized dataset at openFDA.”

From the public health and medical/Rx research front,

  • The Centers for Disease and Prevention announced today,
    • “COVID-19 activity is peaking in many areas of the country with elevated emergency department visits and hospitalizations nationally. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is peaking nationally. Emergency department visits for COVID-19 are elevated in children 0-4 and 5-17 years old. Hospitalizations are elevated in adults 65 years and older.
    • “Influenza
    • “RSV
      • ‘RSV activity is very low.
    • “Vaccination
      • “RSV immunization products will be available beginning in September across most of the continental United States. To protect against RSV-associated lower respiratory tract infections, all infants should receive either maternal RSV vaccination during pregnancy or a long-acting RSV monoclonal antibody, nirsevimab or clesrovimab.
      • “A CDC MMWR report published on August 28, 2025, outlines recommendations from the Advisory Committee on Immunization Practices (ACIP) regarding the use of clesrovimab for preventing severe RSV-related illness in infants. Clesrovimab could further increase access to and protection for infants in the 2025–26 respiratory virus season.”
  • Beckers Hospital Review points out steps that states are taking to override the FDA’s limited Covid vaccination recommendation which the CDC’s Advisory Committee on Immunization Practices (ACIP) will take up at a September 18-19 meeting.
  • Beckers Payer Issues adds that the “Massachusetts’ Division of Insurance and Department of Public Health has issued a bulletin Sept. 3 requiring insurance carriers to cover vaccines as outlined by the state, not just the CDC.”
  • The University of Minnesota’s CIDRAP lets us know,
    • “In a weekly update, the US Centers for Disease Control and Prevention (CDC) today [September 3] reported 23 more measles cases, lifting the country’s total to 1,431, the most since the country reached elimination status in 2000.
    • “For the first time, health officials divided out the cases confirmed in international visitors, which account for 18 of the national cases.
    • “The number of outbreaks remained the same, at 35, double the number for 2024. So far, 86% of cases are linked to outbreaks, compared to 69% last year. To date, 92% of patients were unvaccinated or have an unknown vaccination status. School-age kids are the most affected group, followed closely by adults ages 20 years and older.”
  • The New York Times identifies “6 More Things E.R. Doctors Wish You’d Avoid. Stay out of the emergency room with these tips.
    • “Last winter, I wrote about things emergency room doctors wish you’d avoid, and many more E.R. doctors wrote in to tell me what I had missed.”
      • “Never put your feet on the dashboard.
      • “Don’t forget your eyes when doing yardwork.
      • “And never mow the lawn in open-toed shoes.
      • “Watch out for the front burner.
      • “If you’re choking, forget about privacy.
      • “Don’t take another person’s prescription medication.”
  • The American Hospital Association News notes,
    • “A Health Affairs study published Sept. 2 found that less than 40% of Medicare beneficiaries with opioid use disorder received standard care in alignment with quality measures. Researchers analyzed Medicare enrollment, claims and encounter data to assess the extent to which beneficiaries with OUD received treatment in alignment with eight nationally recognized quality measures in 2020. The study found that Medicare Advantage performed worse than fee-for-service Medicare on six of eight measures, and that Medicare performed worse than Medicaid on all three comparable OUD quality measures available.
    • “The authors said a variety of initiatives could be used to improve OUD treatment for Medicare beneficiaries, including enhanced Medicare coverage, policies enabling more providers to treat beneficiaries with OUD, policies and programs to facilitate care connections following hospitalization or an emergency department visit, and initiatives encouraging beneficiaries to seek treatment.”
  • Medscape explains “Everything Patients Need to Know About Aging on GLP-1s.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “CVS Health is tapping into health system partnerships as it rapidly expands primary care offerings.
    • “CVS has added primary care services at more than 400 MinuteClinic sites across 12 states and Washington, D.C., in the last year or so, said Dr. Creagh Milford, interim president of retail health at CVS Health and president at CVS-owned Oak Street Health. The goal is to offer primary care at all MinuteClinic sites and build a payer-agnostic network to serve patients, he said.
    • “However, the strategy requires buy-in from residents, which isn’t a guarantee in all communities.
    • “The healthcare conglomerate has formed primary care clinical affiliations with three health systems to help with the primary care shift and is looking for more partners. Milford said several dozen conversations are underway about similar agreements. 
    • “We’re seeing a lot of traction,” Milford said. “One of the things that had been a challenge between MinuteClinic and our health system partners is, how do we better coordinate care?” 
    • “The clinical affiliations are another way for health systems to respond to physician shortages and expand access to care.
    • “CVS’ first primary care-driven affiliation was with Atlanta-based Emory Healthcare Network, which was announced in February. As part of the agreement, MinuteClinic offers in-network adult primary care at all 35 clinics in Georgia to most payers through Emory’s integrated network.” 
  • Per Cardiovascular Business,
    • “Congenital heart disease surgical procedures are relying more on 3D echocardiography as it is rapidly transforming the way congenital heart procedures are planned, guided and help manage patients afterwards. The technology is offering cardiac surgeons and interventional cardiologists clearer images, better communication, and safer procedures for even the smallest patients.
    • “3D echo captures the heart in real time and with the full structure of the heart. You can cut through with. So pre-surgical planning and it is now moving into the operating room. Because of the release of the pediatric 3D transesophageal echo (TEE) probes, we can characterize the valve tissues that the surgeons are repairing quite nicely,” explained Pei-Ni Jone, MD, FASE, director of the echocardiography laboratory at Lurie Children’s Hospital Heart Center, professor of pediatric cardiology, Northwestern University Feinberg School of Medicine, member of the American Society of Echocardiography (ASE) Board, and the chair of the ASE Pediatric and Congenital Heart Disease Council Steering Committee.
    • “She said 3D echo offers a surgical view of the valve non-invasively and it can visualize valve failures that happen in the operating room or help determine if a surgeon needs to go back on bypass to repair something.”
  • Per MedTech Dive,
    • “A clinical trial of Medtronic’s Hugo robot has met its primary effectiveness and safety endpoints, the company said Thursday.
    • “Physicians used the robotic-assisted surgery system to treat 193 patients. All of the surgeries were successfully completed. Two people had surgical safety events in the 30 days after treatment that were resolved without complication. 
    • ‘Medtronic has filed for authorization of the system in a urology indication and plans to expand into hernia repair later. The company will compete with Intuitive Surgical for the hernia market.”
  • The American Journal of Managed Care notes,
    • “Rideshare transportation for abnormal [fecal immunochemical test] FIT results can double colonoscopy completion rates, reducing [colorectal cancer] CRC cases and deaths significantly.
    • “The intervention is cost-saving, generating more than $330,000 savings per 1000 people screened due to earlier cancer detection.
    • “Early FIT screening, starting between ages 40 and 49 years, is crucial as CRC rates rise among younger populations.
    • “The study’s microsimulation model projects long-term CRC outcomes, supporting further trials to validate rideshare intervention effectiveness.”

Midweek report

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

From Washington, DC,

  • Beckers Health IT informs us,
    • “Federal lawmakers have introduced a bill to extend Medicare telehealth flexibilities and CMS’ hospital-at-home waiver.
    • “The Telehealth Modernization Act of 2025 would prolong the telehealth program through Sept. 30, 2027, and CMS’ reimbursement of acute hospital care at home through 2030. The measures otherwise expire Sept. 30.
    • “Telehealth is a vital part of our healthcare system, and we must ensure that it is available to patients who need it,” said U.S. Rep. Earl “Buddy” Carter, R-Ga., in a Sept. 2 news release. “By extending telehealth flexibilities for patients, we are making healthcare more accessible, regardless of their physical location.”
    • “Mr. Carter introduced the House bill with Rep. Debbie Dingell, D-Mich., while a companion Senate bill is being led by Sens. Tim Scott, R-S.C., and Brian Schatz, D-Hawaii. Nearly 50 health systems have called for the telehealth extension.”
  • Federal News Network reports,
    • “The Office of Personnel Management is taking a closer look at the details for implementing President Donald Trump’s proposal for a larger pay raise for federal law enforcement personnel next year.
    • “The announcement from OPM comes a couple days after Trump called for a 3.8% pay raise in 2026 for federal employees working in law enforcement jobs.
    • “Certain frontline law enforcement personnel are critical to implementing the President’s strategy to secure the border, protect our country and keep American citizens safe,” OPM said this week in new guidance. “Without special salary rates, the government may find it difficult to recruit and/or retain the number of these personnel needed to properly enforce our borders, uphold our immigration laws and protect law-abiding citizens.”
    • “It’s not yet clear which specific positions or how many law enforcement officials will be included in the new special salary rate. OPM said it plans to consult with the departments of Homeland Security, Justice and Interior to define which jobs will be eligible for the larger law enforcement pay raise next year.
    • “Generally, though, OPM said the upcoming special salary rate will cover agents in the Border Patrol and the Drug Enforcement Administration, criminal investigators at Immigration and Customs Enforcement (ICE), Secret Service personnel, officers at the Federal Protective Service and the FBI, and correctional officers at the Federal Bureau of Prisons — among several other groups.”
  • and
    • “After unveiling a series of immediate acquisition changes over the summer, the Trump administration is on track to debut a formal rulemaking to overhaul and streamline the Federal Acquisition Regulation, or the FAR, this fall.
    • “Larry Allen, the associate administrator for General Services Administration’s Office of Government-wide Policy, discussed the ongoing FAR revisions and the forthcoming rulemaking during AFCEA Bethesda’s “Health IT” conference in Washington on Wednesday.
    • “Under an April executive order, the White House Office of Federal Procurement Policy and the FAR Council are leading an effort to “return the FAR to its statutory roots, rewritten in plain language, and remove most non-statutory rules.”
    • “In recent months, the FAR Council has issued a series of “class deviations” for multiple parts of the FAR. Recent deviations have focused on prioritizing the use of governmentwide contracts and simplifying commercial acquisition.” * * *
    • “In follow-up guidance to the executive order, the Office of Management and Budget said the FAR Council will turn to formal rulemaking after it has posted model deviations for all FAR parts.”
  • It’s worth adding that reginfo.gov no longer carries an “under repair” warning and while the regulatory review pages are up to date, the regulatory agenda page still features the Fall 2024 edition.
  • Govexec considers whether FEGLI Option B is really the best life insurance choice? FEGLI plans remain a solid life insurance option for federal employees, but, depending on the coverage, it may also be wise to look to the private market.
  • Following up on yesterday’s FEHBlog, Beckers Hospital Review notes,
    • “A federal rule enabling real-time access to prescription drug pricing, coverage details and prior authorization requirements is set to take effect Oct. 1. 
    • “The regulation, finalized in July as part of the CMS Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System final rule, will require healthcare providers to use certified health IT systems to electronically submit prior authorization requests, check real-time prescription drug pricing during patient encounters and share electronic prescription data with pharmacies and insurers.”
  • Fierce Healthcare adds,
    • “The Department of Health and Human Services’ investigation unit and health IT offices are stepping up enforcement of information blocking committed by providers, health IT developers and health information exchanges, the department announced Wednesday. 
    • “The news comes as Trump’s HHS is trying to improve the flow of patient health information by securing voluntary commitments by 60 major healthcare and tech companies to advance interoperability. 
    • “A press release by HHS says Health Secretary Robert F. Kennedy Jr. has “directed increased resources” to investigate and enforce information blocking rules.
    • “The Office of the Assistant Secretary for Technology Policy (ASTP/ONC) has already begun to review reports of information blocking and provide technical assistance to HHS’ Office of the Inspector General to assist their investigations, Assistant Secretary Thomas Keane said in a statement.” 

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect. Through the RDEP process, sponsors will receive clearer guidance on the types of evidence that can be used to demonstrate substantial evidence of effectiveness.
    • “Drug developers – and the patients they hope to treat – deserve clear, consistent information from the FDA,” said FDA Commissioner Marty Makary, M.D., M.P.H.  “These principles ensure that FDA and sponsors are aligned on a flexible, common-sense approach within our existing authorities, and that we incorporate confirmatory evidence to give sponsors a clear, rigorous path to bring safe and effective treatments to those who need them most.”    
  • BioPharma Dive reports,
    • “Biohaven’s top executive said his team is well-prepared to sell a therapy that could be not only the first approved medicine for a group of rare brain diseases, but also the company’s first commercial product since it sold off its main revenue driver a few years ago.
    • “After some delays, the Food and Drug Administration is set to issue an approval verdict on this medicine sometime between October and the end of December. If cleared for market, the oral drug would be sold as Vyglxia and used to treat patients with spinocerebellar ataxia, a type of genetic disorder where the progressive erosion of nerve cells causes problems with movement, coordination and brain function.”
  • Per MedTech Dive,
    • “Medtronic has received an expanded label from the Food and Drug Administration to pair its MiniMed 780G insulin pump with a glucose sensor being developed by Abbott for Medtronic.
    • “Medtronic and Abbott will submit required compliance documentation for sensor integration and marketing in the coming weeks, finishing the regulatory process, the companies announced Tuesday.
    • “The FDA decision also expands the insulin pump to adults with Type 2 diabetes.”

From the public health and medical/Rx research front,

  • The American Hospital News tells us,
    • “The Centers for Disease Control and Prevention is predicting a similar combined number of peak hospitalizations from COVID-19, the flu and respiratory syncytial virus this upcoming respiratory virus season compared to last year’s, according to its 2025-26 outlook released Aug. 25. The agency is predicting higher peak weekly COVID-19 hospitalization rates this season, particularly if a variant with moderate immune-escape properties emerges.”
  • and
    • “The AHA Sept. 3 released a study conducted by KNG Health Consulting that found Medicare patients who receive care in a hospital outpatient department are more likely to come from geographically isolated and medically underserved communities and be sicker and more complex to treat than Medicare patients treated in independent physician offices. Specifically, the study found that Medicare patients who are seen in HOPDs — including those with cancer — are more likely to be from rural and lower-income areas, living with more severe chronic conditions, dually-eligible for both Medicare and Medicaid, previously hospitalized or cared for in a hospital emergency department, and under 65 and eligible for Medicare based on disability.”
  • The Wall Street Journal discusses how to get the new Covid vaccine.
  • NBC News adds,
    • “An over-the-counter nasal spray which has been used for years as a safe and effective treatment for seasonal allergies could potentially prevent Covid infections, according to clinical trial results released Tuesday.
    • “The antihistamine azelastine works as an antiviral against a range of respiratory infections, including influenza, RSV and the virus that causes Covid, a growing number of studies have shown.” * * *
    • “Our findings suggest azelastine could serve as a scalable, over-the-counter prophylactic against Covid, especially when community transmission is elevated or in high-risk settings such as crowded indoor events or travelling,” said Dr. Robert Bals, professor of internal medicine and pneumology at Saarland University and the study’s senior author.
    • “The trial had limitations, namely that the participants were all young and relatively healthy, he said. 
    • “Bals said that azelastine should not be seen as a replacement for vaccinations, and larger studies were needed before recommending it as a routine preventative measure for the general public, and especially vulnerable groups.”
  • Per a National Institutes of Health news release,
    • “Researchers funded by the National Institutes of Health (NIH) have found that a single injection of the antibiotic benzathine penicillin G (BPG) successfully treated early syphilis just as well as the three-injection regimen used by many clinicians in the United States and elsewhere. These findings from a late-stage clinical trial suggest the second and third doses of conventional BPG therapy do not provide a health benefit. The results were published today in The New England Journal of Medicine.
    • “Benzathine penicillin G is highly effective against syphilis, but the three-dose regimen can be burdensome and deter people from attending follow-up visits with their healthcare providers,” said Carolyn Deal, Ph.D., chief of the enteric and sexually transmitted infections branch of NIH’s National Institute of Allergy and Infectious Diseases (NIAID). “The new findings offer welcome evidence for potentially simplifying treatment with an equally effective one-dose regimen, particularly while syphilis rates remain alarmingly high.”
    • “Syphilis is a common sexually transmitted infection (STI) caused by the bacterium Treponema pallidum. The United States reported 209,253 total syphilis cases and 3,882 congenital syphilis cases in 2023, representing 61% and 108% increases over 2019 numbers, respectively. Without treatment, syphilis can result in neurological and organ damage as well as severe pregnancy complications and congenital abnormalities. Syphilis can also increase a person’s likelihood of acquiring or transmitting HIV.
    • “BPG is one of the few antibiotics known to effectively treat syphilis, and stockouts are common worldwide. The antibiotic is currently being imported to the United States to resolve a nationwide shortage.”
  • Per Beckers Hospital Review,
    • “Researchers have successfully used repurposed cancer drugs to target dormant breast cancer cells, aiding in the delay or prevention of recurrence, according to a study published Sept. 2 in Nature Medicine. 
    • “Researchers from Philadelphia-based University of Pennsylvania’s Abramson Cancer Center and Perelman School of Medicine enrolled 51 breast cancer survivors to identify and target the cells with existing cancer drugs.” * * *
    • “Read the full study here.” 
  • Per Healio,
    • “Nonsurgical treatments may offer long-term reductions in pain and disability for patients with chronic low back pain.
    • “Treatment options included cognitive behavioral therapy, mindfulness and exercise.”
  • Per Health Day,
    • “Guidelines recommend that preschoolers diagnosed with ADHD first get six months of behavioral therapy before drug therapy is initiated
    • “New research shows this rule is followed by U.S. doctors only about 14% of the time, and that could mean poorer outcomes for kids
    • “A lack of access to therapists is often cited as a reason for starting meds soon, but experts say there are ways around that.”

From the U.S. healthcare business front,

  • Fierce Pharma points out,
    • “After joining multiple other drugmakers on the U.S. investment bandwagon earlier this year, Gilead Sciences is providing further details on where it plans to channel its $32 billion pledge.
    • “Gilead has broken ground on a new pharmaceutical development and manufacturing hub at its headquarters in Foster City, California, the company said Tuesday.
    • “The new facility, which will reach five stories and cover 180,000 square feet, will serve the company’s technical development and manufacturing teams, leveraging a mix of digitalization, autonomous robotics and real-time digital monitoring. Additionally, the project is expected to boost Gilead’s capabilities and capacity around biologics, which the company described as a “central pillar” of its broader growth strategy.”
  • Beckers Hospital Review lets us know,
    • “Cincinnati-based TriHealth has completed the acquisition of Clinton Memorial Hospital, a 140-bed facility in Wilmington, Ohio, marking its sixth acute care hospital.
    • “The facility will be renamed TriHealth Clinton Regional Hospital and serve as a hub for the system’s specialized services, including women’s health, cancer, heart and vascular, neurosciences and stroke care.
    • “This new name will extend TriHealth’s brand promise to ‘see, to hear and to heal … delivering surprisingly human care’ to the residents of Clinton County,” TriHealth President and CEO Mark Clement said in a Sept. 2 news release. “And it will also affirm TriHealth’s commitment to invest in the hospital and expand services locally, establishing it as a regional hub for TriHealth’s exceptional, nationally recognized care.”
  • Fierce Healthcare reports,
    • “HonorHealth, an Arizona-based health system, is acquiring a number of Evernorth Care Group locations across Phoenix.
    • “Evernorth Care Group lists 18 centers offering integrated primary care services to nearly 80,000 patients throughout the metropolitan area. The clinics will become part of HonorHealth at the close of the deal, slated for January 2026, pending regulatory approvals.
    • “This acquisition enhances the services we offer and expands Valley residents’ access to care,” HonorHealth CEO Todd LaPorte said in the announcement. The financial terms were not disclosed.” 
  • Beckers Payer Issues relates,
    • “UnitedHealthcare’s prior authorization gold card program has seen a more than 40% increase in the number of qualifying provider groups in 2025, the company shared with Becker’s.
    • “Launched in October 2024, the program reduces prior authorization requirements in favor of advance notification for provider groups that consistently adhere to evidence-based care guidelines.
    • “Providers can lose gold-card status because of patient safety issues, failure to cooperate with quality and patient safety activities, failure to make timely responses to requests for information, or because they no longer meet program requirements. UnitedHealthcare conducts annual evaluations for gold card qualification, with determinations effective on Oct. 1 every year. 
    • “On Sept. 1, provider groups could begin viewing their program status in the UnitedHealthcare Provider Portal. Starting Oct. 1, additional groups will be eligible.”
  • and
    • “Economic uncertainty and policy changes from the current administration have changed the way health plans operate over the past year. Many have found workarounds to continue efficiency and growth.
    • “Becker’s connected with five leaders to learn their biggest accomplishments so far in 2025.”
    • Check it out.
  • Milliman has posted its “2025 Milliman Retiree Health Cost Index.”
  • McKinsey & Co. discusses “the quantum revolution in pharma: Faster, smarter, and more precise.”
    • “Quantum computing presents a multibillion-dollar opportunity to revolutionize drug discovery, development, and delivery by enabling accurate molecular simulations and optimizing complex processes.”
  • Radiology Business notes,
    • “Hospital- and private equity-affiliated radiology practices command significantly higher prices than their independent practice counterparts, according to new research published Tuesday. 
    • “Consolidation of imaging groups has accelerated in recent years, with limited evidence on how this change impacts economics within the specialty. Researchers with Brown University recently set out to understand how such M&A activity has changed prices for radiology services, sharing their findings in the Journal of the American College of Radiology (JACR). 
    • “They found a noteworthy gap, with negotiated professional prices for hospital-based radiology services about 43% higher than independents. That’s compared to about 16% higher for investor-backed radiologists versus others in private practice. 
    • “Our findings demonstrate significant differences in negotiated radiologic service prices by practice ownership, with hospital and PE-affiliated practices able to negotiate higher professional fees than independent practices,” corresponding author Yashaswini Singh, PhD, MPA, a healthcare economist and professor with the Providence, Rhode Island, institution, and colleagues concluded. “These results highlight the financial implications of ongoing consolidation in radiology and underscore the need for continued research into how these trends affect radiologists, insurers and patients.”

Thursday report

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

From Washington, DC,

  • The Washington Post reports,
    • “The White House on Thursday selected a top deputy of Health and Human Services Secretary Robert F. Kennedy Jr. to serve as acting head of the Centers for Disease Control and Prevention after a clash over vaccine policy ended in the departure of several agency leaders, according to two people familiar with the decision.
    • “The selection of Jim O’Neill, currently the deputy secretary of HHS, as interim leader of the CDC, potentially clears a path for Kennedy to continue his efforts to overhaul federal vaccine policy after the agency’s previous leader, Susan Monarez, balked at his requests.” * * *
    • “Pressed by lawmakers in his confirmation hearings in May about his public health beliefs, O’Neill said that he was a staunch supporter of vaccines.
    • “I’m very strongly pro-vaccine, I’m an adviser to a vaccine company, I support the CDC vaccine schedule,” he told senators in one exchange. But he also said that the federal government had overreached during the coronavirus response, and he criticized the Biden administration’s efforts to mandate coronavirus vaccines for federal workers.”
  • BioPharma Dive informs us,
    • “A federal vaccine panel recently remade by Health and Human Services Secretary Robert F. Kennedy Jr. will meet in September to discuss and potentially vote on recommendations for vaccines against COVID-19, hepatitis B and measles. 
    • A”ccording to a federal notice posted Thursday, the Advisory Committee on Immunization Practices will meet Sept. 18 and 19. A detailed agenda is not yet available, but the notice mentions that vaccines for respiratory syncytial virus may also be discussed. 
    • “The anticipated meeting will be the second by the reconstituted ACIP since Kennedy fired all 17 of its prior members and replaced them with seven hand-picked advisers. In the first, the new panelists appeared skeptical of evidence supporting COVID shots’ safety and efficacy and debated a controversial preservative that’s long been a target of vaccine skeptics despite data showing it to be generally safe.” 
  • Per a Congressional news release,
    • “Today, U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, called for the U.S. Department of Health and Human Services Advisory Committee on Immunization Practices (ACIP) to indefinitely postpone their September 18th meeting.
    • “Serious allegations have been made about the meeting agenda, membership, and lack of scientific process being followed for the now announced September ACIP meeting. These decisions directly impact children’s health, and the meeting should not occur until significant oversight has been conducted. If the meeting proceeds, any recommendations made should be rejected as lacking legitimacy given the seriousness of the allegations and the current turmoil in CDC leadership,” said Dr. Cassidy.”
  • Per another Congressional News release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will convene for a markup followed by a hearing on President Trump’s 2026 Health Care Agenda on Thursday, September 4. The markup will be held at 9:30 AM and will be immediately followed by the health care hearing at 10:00 AM.
    • “Secretary Kennedy has placed addressing the underlying causes of chronic diseases at the forefront of this Administration’s health care agenda,” said Crapo. “I look forward to learning more about the Department of Health and Human Services’ Make America Healthy Again actions to date and plans moving forward.”
  • The Congressional Research Service issued a report about “Expiring Health Provisions of the 119th Congress” while Healthcare Dive points out “top healthcare legislation to watch so far this year. Federal lawmakers have proposed dozens of bills targeting core healthcare issues, including 340B, Medicaid, AI and site-neutral payments.
  • The American Hospital Association News notes,
    • “The Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology Aug. 26 released a notice seeking comments on a proposed survey of health technology companies to assess implementation and experiences with information blocking, the 21st Century Cures Act and health care application programming interfaces. Comments must be submitted by Sept. 25.”
  • and
    • “The AHA Aug. 26 responded to a request for information as part of the introduction of the Healthy Moms and Babies Act, bipartisan legislation that seeks to improve maternal and child health by increasing services and support and coordinating care. The AHA responded to a request to provide feedback on how to incorporate a low-volume payment adjustment for home health models for pregnant and postpartum women. In response to the RFI from the bill’s co-sponsors, Sens. Chuck Grassley, R-Iowa, and Maggie Hassan, D-N.H., the AHA highlighted the financial and staffing challenges that rural hospitals face, among other issues, which can lead to obstetric unit closures and other reductions in labor and delivery services.”
  • Per Beckers Hospital Review,
    • The American Hospital Association sharply criticized a 340B rebate model pilot program from the Health Resources and Services Administration, an agency of HSS, warning the model threatens to undermine three decades of success under the existing 340B drug pricing program. 
    • In an Aug. 27 letter addressed to Thomas Engels, administrator of the HRSA, the AHA outlined serious concerns about the agency’s decision to shift from upfront discounts to a rebate model for select Medicare Part D drugs. 
    • The association also urged the agency to abandon the pilot, calling the model a “solution in search of a problem” that could harm safety-net hospitals. “There is no sound reason for HRSA to make such a profound change,” the letter stated. “We are confident that what it calls a ‘test’ will ultimately fail.” 
  • Tammy Flanagan, writing in Govexec, discusses “Important dates for Social Security and Medicare; Key milestones and deadlines every beneficiary should know.” 

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “The FDA approved the first-ever generic form of a GLP-1 receptor agonist specifically indicated for weight loss, Teva Pharmaceuticals announced Thursday.
    • “The generic form of liraglutide (Saxenda) is indicated for adults with obesity or overweight with at least one weight-related comorbidity in combination with diet and exercise, as well as for adolescents ages 12 to 17 who are over 132.2 lb with obesity.
    • “Liraglutide was first approved in 2014 for chronic weight management in adults, and this indication was expanded in 2020 to include teens.” * * *
    • “This is the first GLP-1 generic for weight loss, but other generics have been previously approved for type 2 diabetes, including liraglutide (Victoza) and exenatide (Byetta).”

From the public health and medical research front,

  • JAMA informs us,
    • “Question  Does partial heart transplant provide a safe and effective valve replacement option that also has capacity for growth in patients with congenital heart disease?
    • “Findings  In this case series of 19 patients who underwent partial heart transplant, all valves demonstrated functional durability and growth over time with maintenance immunosuppression. No patient experienced valve-related reintervention, and leaflet measurements confirmed true tissue growth.
    • “Meaning  Partial heart transplant appears to be a safe and feasible procedure that enables valve growth, representing a promising solution to overcome the limitations of current nongrowing valve replacement options.”
  • The New York Times writes about youngsters who successfully have received partial health transplants.
  • Per MedPage Today,
    • “A study of over 112,000 U.S. adults found that 14% started a GLP-1 receptor agonist after bariatric surgery.
    • “Timing of GLP-1 agent initiation after bariatric surgery varied, and optimal timing needs to be investigated further.
    • “Sleeve gastrectomy patients and those who regained more weight after surgery were more likely to start a GLP-1 agent.”
  • and
    • “Estradiol hormone therapy was associated with higher memory scores in postmenopausal women.
    • “Transdermal estradiol was linked with better episodic memory, while oral estradiol was tied to prospective memory.
    • “Alzheimer’s risk is higher in women and may be related to menopausal loss of neuroprotective sex steroids.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Novo Nordisk has taken the next step in selling its drugs directly to patients by pointing them to telehealth providers that can write prescriptions for its popular obesity medication Wegovy. The company now links to select virtual providers on the NovoCare direct-to-patient pharmacy website it launched earlier this year, joining other pharma giants that have leaned into direct sales through their own online portals. 
    • “These new direct-to-consumer medication sites combine telehealth access points with pharmacy fulfillment, coupons, and patient information — sometimes with exclusive cash-pay pricing. Eli Lilly launched LillyDirect in January 2024 and was followed by Pfizer’s patient-facing site PfizerForAll later in the year. Partnering with telehealth companies is growing as a pharma marketing tactic even as the practice has come under scrutiny from lawmakers and health policy experts who raise concerns it may create improper relationships between drugmakers and health care providers.”
  • The American Medical Association offers details on GLP-1 spending in the U.S.
  • Healthcare Dive reports,
    • “Walgreens is officially a private company after the troubled retailer’s $10 billion sale to private equity firm Sycamore Partners closed Thursday.
    • “Moving forward, Walgreens’ healthcare subsidiaries Shields Health Solutions, CareCentrix and VillageMD will operate as separate businesses. The Boots Group, Walgreens’ international retail pharmacy chain, will also be spun out, creating five standalone companies.
    • “Sycamore appointed retail veteran Mike Motz as Walgreens CEO, replacing current chief executive Tim Wentworth. Motz has formerly served as CEO of Staples U.S. Retail, a Sycamore portfolio company, and as president of Canada-based pharmacy chain Shoppers Drug Mart.” 
  • Modern Healthcare relates,
    • “Lewis Drug locations are set to become part of Sanford Health this fall, following a decades long partnership between the two organizations. 
    • “Lewis Drug, a retail pharmacy company, will continue to operate under its own brand, according to a Thursday press release. Its existing staff will be employed by Sanford Health. 
    • “The two organizations have a joint venture, Lewis Family Drug, comprised of 44 locations offering retail items and pharmacy services. Sanford Health operates clinics at 11 Lewis Drug locations. While there are no immediate plans for additional clinics after the deal is expected to be finalized this fall, Sanford is open to that possibility in the future, Nick Olson, executive vice president and chief financial officer of Sanford Health, said Thursday.”
  • and
    • “U.S. Digestive Health, a large gastroenterology practice in Southeastern Pennsylvania, has been sold by private equity firm Amulet Capital Partners to SCA Health, a subsidiary of UnitedHealth Group under the Optum umbrella. 
    • “The deal, completed in January with little public notice, shifts a network of about 150 physicians and 24 ambulatory surgery centers across Pennsylvania and Delaware to the nation’s largest health insurer. Financial terms were not disclosed.
    • “Amulet, based in Greenwich, Connecticut, formed U.S. Digestive in 2019 by consolidating three regional practices.” 
  • Per Beckers Payer Issues,
    • “The California and Texas medical associations are urging Cigna to rescind a new policy they say will increase administrative burdens and create a barrier to appropriate reimbursement.  
    • “Beginning Oct. 1, Cigna’s new Evaluation and Management Coding Accuracy policy will review CPT evaluation and management codes 99204-99205, 99214-99215, and 99244-99245 for billing and coding accuracy. Some services may be adjusted by one level when guidelines are not met. 
    • “To better align with the American Medical Association’s Evaluation and Management services guidelines, Cigna Healthcare will implement a new reimbursement and coding accuracy policy for E/M codes that are being inappropriately billed as a higher level,” a Cigna spokesperson told Becker’s. “This review will only apply to approximately 3% of in-network physicians who have a consistent pattern of coding at a higher E/M level compared to their peers. Claims will be individually reviewed for coding accuracy and payment may be adjusted by one level to meet AMA guidelines. Physicians may request reconsideration or appeal our decision if they feel the higher payment is appropriate.”

Midweek Update

David Ermer–CDC, CMS, COVID-19 vaccine, Generative AI, Government Contracting, Medical / Rx research, Medicare, No Surprises Act, OPM, Patient safety, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Meritalk reports,
    • “With the Office of Personnel Management (OPM) on track to lose one-third of its workforce by the end of the year, OPM Director Scott Kupor said on Tuesday that he’s looking to technology to help steady the agency during its ongoing restructuring.
    • “Kupor, who the Senate confirmed as OPM director last month, said that his team is currently conducting a “reprioritization” effort to determine the top critical areas for the agency to focus on – and whether or not they need more headcount to get the job done.
    • “There may be cases where maybe we actually are short people,” Kupor said during an Aug. 26 event hosted by Federal News Network.
    • “We’re not perfect, and I fully acknowledge that there just may be areas where we need to revisit. So, there will be, I’m sure, some places where we have cut deeper than was appropriate, and we’ll have to make some changes,” he said.
    • “Some of those hiring efforts could target fresh talent, but Kupor said the agency may also look to rehire some employees who chose to participate in the deferred resignation program.”
  • The Wall Street Journal reports at 8:35 pm ET Wednesday,
    • “Susan Monarez, the director of the Centers for Disease Control and Prevention, has been pushed out of the job, a senior Trump administration official said Wednesday.
    • “Monarez, who led the agency for less than a month, clashed with Health and Human Services Secretary Robert F. Kennedy Jr. and members of his staff, the official said. President Trump had nominated her to lead the CDC in March after dropping his first pick. Previously the agency’s acting director, Monarez was the first CDC head without a medical degree in more than 70 years.
    • “Lawyers for Monarez said in a statement that she has neither resigned nor received notification from the White House that she has been fired. They also said she will not resign. “When CDC Director Susan Monarez refused to rubber-stamp unscientific, reckless directives and fire dedicated health experts, she chose protecting the public over serving a political agenda,” they said. “For that, she has been targeted.”
    • “Three senior CDC leaders, including Dr. Debra Houry, the agency’s chief medical officer, submitted their resignations Wednesday, according to emails viewed by The Wall Street Journal.”
  • Healthcare Dive tells us,
    • “The process set up by the No Surprises Act to settle disputes between providers and insurers about out-of-network claims is generating billions of dollars in extra costs for the healthcare system — costs that could trickle down in the form of higher consumer premiums, according to a new analysis.
    • “Independent dispute resolution, or IDR, has created an estimated $5 billion in total costs between its inception in 2022 and the end of last year, according to the report published in Health Affairs on Monday. The high amount of claims, significant provider participation and lofty offer amounts are driving the spending, researchers found.
    • “The analysis raises questions for policymakers concerned about curbing healthcare costs. In particular, Washington should consider tackling the high volume of ineligible disputes clogging up the process — and scrutinize the role of private equity, given providers backed by the firms are responsible for an outsized portion of disputes, researchers said.”
  • FEHBlog note — The No Surprises Act arbitration which is supposed to resemble baseball arbitration fails to include the safeguards found in actual baseball arbitration like a hearing at which the parties have access to both offers and can debate them before the decisionmakers.
  • Fierce Healthcare informs us,
    • “The National Committee on Quality Assurance (NCQA) has launched an artificial intelligence working group to determine how to best measure performance of high-risk AI once it has been deployed by health plans and providers. 
    • “The 35-year-old organization runs a spate of quality measurement and reporting programs, like health plan accreditation and the Healthcare Effectiveness Data and Information Set (HEDIS) measures used by 90% of health plans, according to the Office of the Assistant Secretary for Planning and Evaluation. 
    • “The NCQA has convened more than 30 organizations to share their experiences using AI and help create standards for the technology. Some members of its AI working group are the American Academy of Family Physicians, America’s Health Insurance Plans, Blue Cross Blue Shield of Tennessee, the Community Care Plan, Covered California, the Kaiser Foundation Health Plan and United HealthCare.
    • “As the modality of care, as the channels of healthcare delivery continue to evolve, and as we continue to see a very evolving healthcare delivery landscape, we do want to take a very hard look at what additional things we can do to continue putting that lens on quality and putting quality front and center,” Vik Wadhwani, chief transformation officer at NCQA, said in an interview.”
  • Kushner & Co. reminds us that the time for circulating Medicare prescription drug creditable coverage notices is approaching. The deadline is October 15, 2025.
    • For 2025, with the Inflation Reduction Act lowering the out-of-pocket maximum to $2,000 (from $8,000 in 2024), many employer prescription drug plans—and especially those with High-Deductible Health Plans—may find that their plans are no longer creditable. Further, new changes for 2026 may also impact these notices. Be sure to check with your group medical plan insurance carrier or TPA [or PBM] to ensure you’re in compliance in determining whether your prescription drug plan is creditable or noncreditable.
  • The FAR Council today finalized the inflation adjustments to FAR thresholds which take effect on October 1, 2025. The key change for FEHB carriers is the following:
    • “The cost or pricing data threshold at FAR 15.403–4, for contracts awarded before July 1, 2018, increases from $750,000 to $950,000. For contracts issued on or after July 1, 2018, the threshold increases from $2 million to $2.5 million.”
    • 90 Fed. Reg. 41873 (August 27, 2025)
    • OPM’s FEHBAR treats this threshold as the subcontract preapproval threshold for experience rated carriers and the flow down trigger for the significant events clause. 48 C.F.R. Secs. 1652.222-70, 1652.244-70.

From the Food and Drug Administration (FDA) front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration authorized three new Covid-19 vaccines—from Pfizer and its partner BioNTech, and Moderna and Novavax—that target a variant of the coronavirus known as LP.8.1. This was the dominant circulating strain when FDA advisers picked a target in May. 
    • “The companies are expected to begin shipping doses to pharmacies and other vaccination sites within days. This is the fourth-year companies have updated Covid shots to target the primary variant that is circulating, in hopes the shots will better protect people from severe illness through the fall and winter months.
    • “In a change this year, the FDA cleared use of the updated vaccines in a smaller population. The three vaccines are cleared for everyone 65 and older, and for people in younger populations who have underlying conditions that put them at higher risk of severe Covid-19. 
    • “Pfizer’s vaccine was cleared for at-risk people ages 5 through 64, Moderna’s in at-risk people six months and older, and Novavax for at-risk people 12 and older.
    • “In previous years, U.S. health officials recommended the booster shots in most people six months and older, even if they didn’t have at-risk conditions.” * * *
    • “In deciding on vaccine coverage, health insurers typically follow recommendations by the Advisory Committee on Immunization Practices, or ACIP, which advises the CDC. They may also consider clinical recommendations from medical societies. 
    • “No meeting has been scheduled for ACIP to consider the new updated boosters. Kennedy fired all members of the ACIP in June and replaced them with people including some vaccine skeptics.
    • “A trade group for health-insurance companies, America’s Health Insurance Plans, said health plans will continue to follow requirements for ACIP-recommended vaccines.”
  • FEHBlog note — Indeed, the Affordable Care Act requires that health plans waive cost sharing for in-network administration of vaccines recommended by ACIP and confirmed by the CDC (or the HHS Secretary in the event of a vacancy in the CDC directorship.).
  • Cardiovascular Business adds,
    • “The U.S. Food and Drug Administration (FDA) is warning the public about a new safety issue associated with Johnson & Johnson MedTech’s Automated Impella Controller (AIC). 
    • “This latest alert was put in place after Johnson & Johnson MedTech received reports that some of the Pump Driver Circuit Assemblies of its AICs contain 25V-rated tantalum capacitors instead of the expected 35V-related tantalum capacitors. This can cause the pump’s performance to suffer, and there a risk of the pump stopping altogether and triggering an “Impella Failure” or “Impella Stopped. Controller Failure” alarm. 
    • “One patient death has been linked to this issue. 
    • “This alert covers a total of 69 AICs. Full lists of the affected product codes and serial numbers are available as part of the FDA’s advisory. Anyone with one of the affected devices is urged not to use it any longer. Instead, the device should be quarantined until additional information is made available.
    • “The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available,” according to the advisory.”

From the judicial front,

  • Bloomberg Law reports,
    • “Cigna Health & Life Insurance Co. reached a class-wide settlement in a family’s lawsuit saying the insurer breached its fiduciary duties by failing to maintain an up-to-date list of in-network medical providers.
    • “The parties reached a preliminary agreement after a mediation session with a retired judge and plan to file details of the deal for court approval by Sept. 19, they said in a status report docketed Monday in the US District Court for the Northern District of Illinois. The filing didn’t include details about the terms of the settlement.” * * *
    • “Judge Manish S. Shah allowed portions of the case to advance in February, saying the family has a viable fiduciary breach claim based on Cigna’s failure to properly resolve the matter in a way that didn’t force them to foot the bill. But Shah dismissed the family’s claim for wrongfully denied benefits under the Employee Retirement Income Security Act because Cigna correctly paid their benefits according to the terms of their health plan.”

From the public health and medical research front,

  • Fierce Healthcare lets us know,
    • “Advancements in technology, testing and imaging have transformed cancer detection and risk assessment, enabling them to be faster and more precise.
    • “But providing patients with a cancer risk score or identifying those at high risk is only one step in cancer prevention. Getting patients to act on their cancer risk and get supplemental screening is the next big leap, and CancerIQ is focused on closing this gap.
    • “The company, which offers healthcare providers a cancer-focused precision health platform, developed new capabilities to provide patients at elevated risk for cancer with “hyper-personalized” patient education, engagement and navigation support. The new features were built on insights from thousands of high-risk patient journeys and backed by behavioral science with the aim to drive sustained follow-through on supplemental screenings that detect cancer earlier, according to executives.
    • “The first release focuses on screening breast MRI, with plans to support additional patient populations, including those eligible for low-dose lung CT.”
  • BioPharma Dive reports,
    • “People with early breast cancer who were treated in a late-stage study with Eli Lilly’s drug Verzenio and standard hormone therapy lived longer than those given hormone therapy alone, the company reported Wednesday.
    • “The summary results come from Lilly’s monarchE study, which began in 2017 and enrolled more than 5,600 adults with high-risk breast cancer that tested positive for hormone receptors but negative for a protein called HER2. Lilly said the improvement in survival was “statistically significant and clinically meaningful.”
    • “The study previously met its main goal, showing the addition of Verzenio improved invasive disease-free survival — data that supported a 2021 approval in this treatment setting. The overall survival findings, which were a secondary endpoint, will be presented at an upcoming medical meeting, Lilly said.”
  • STAT News relates,
    • “Akeso, a Chinese biotech with a drug positioned to rival Merck’s megablockbuster Keytruda, has reported for the first time that the therapy can improve patient survival.
    • “The therapy, ivonescimab, showed a statistically significant survival benefit as a second-line treatment when combined with chemotherapy to treat non-small cell lung cancers. The patients’ cancers had progressed after getting therapies targeting EGFR, a protein that can drive tumor growth. 
    • “The company described the results of the Chinese trial as clinically meaningful in a report for the first half of the year released on Tuesday. But it didn’t delve into details, which Akeso plans to share at an upcoming medical conference.”
  • Per Fierce BioTech,
    • “Amylyx’s withdrawn-from-market Relyvrio has failed to make an impact on primary or secondary endpoints in a rare neurodegenerative disease, prompting the company to discontinue the program.
    • “Oral therapy Relyvrio, which Amylyx is again referring to as AMX0035, was tested in progressive supranuclear palsy (PSP), a fatal and rapidly progressing condition that impacts mobility, eye movements, swallowing and speech. Currently, there aren’t any approved treatments for the disease.”
    • “Amylyx’s phase 2/3b study was measuring AMX0035’s impact on disease progression and severity using a 28-item, condition-specific scale. The phase 2 portion of the trial found no difference in patients receiving AMX0035 compared to placebo at 24 weeks, according to an Aug. 27 company release.
    • “Given the results, the company has discontinued the phase 2b trial, plus a related open-label extension study. Amylyx has also terminated plans for the phase 3 portion of the study.”
  • Per Health Day,
    • ‘Few teens with depression receive treatment, with disparities seen based on residence, gender, and race, according to a study published online Aug. 20 in PLOS Mental Health.
    • “Su Chen Tan, from the University of Tennessee in Knoxville, and colleagues used data from adolescents (aged 12 to 17 years) with major depressive episodes (MDE) participating in the 2022 U.S. National Survey on Drug Use and Health to assess mental health service utilization by rurality, race/ethnicity, gender, age, health insurance coverage, and poverty level.
    • “The researchers found that 19.2 percent of adolescents experienced MDE, but only 47.5 percent received treatment within the past year. There were significantly lower odds of receiving specialist treatment for adolescents in rural areas versus their urban counterparts (adjusted odds ratio [aOR], 0.64). Further, odds of receiving telehealth services were significantly lower for rural adolescents (aOR, 0.64) but were significantly higher for adolescents with insurance (public insurance: aOR, 2.99; private insurance: aOR, 3.82). Compared with younger adolescents, older adolescents had lower odds of utilizing school-based services (aOR, 0.52). Female adolescents had greater odds of utilizing any mental health treatment than male adolescents (aOR, 1.59), while Black adolescents had significantly lower odds of utilizing any mental health treatment versus non-Hispanic White adolescents (aOR, 0.36).”
  • and
    • “Two-thirds of women in their child-bearing years have an increased risk for birth defects due to a lifestyle factor they can change, a new study says.
    • “These risk factors — low levels of vitamin B9 (folate), unmanaged diabetes or exposure to tobacco smoke — increase the odds of a serious birth defect in any child they might have, researchers said.
    • “Heart defects, cleft palates and defects of the brain and spinal cord are among the problems that could be headed off if women took steps to improve their health prior to pregnancy, researchers reported today in the American Journal of Preventive Medicine.”

From the U.S. healthcare business front,

  • Healthcare Dive points out Blue Shield of California names interim CEO Mike Stuart to permanent chief executive.
  • Beckers Payer Issues notes,
    • “AM Best has downgraded its outlook for the health insurance sector from stable to negative, citing escalating medical costs and increased utilization across government, commercial and ACA plans.
    • “The credit rating agency noted higher utilization of specialty drugs, increased physician visits, more inpatient admissions and a surge in behavioral health claims. The coding intensity of medical services has also increased, according to an Aug. 25 news release.”
  • STAT News reports,
    • “Dressed in red and black jackets reminiscent of Star Trek uniforms, the heads of Epic’s data and AI divisions, Phil Lindemann and Seth Hain, described an aspirational vision for artificial intelligence at the end of last week’s Epic UGM keynote. Using the data stored in Cosmos — Epic’s de-identified patient record research database — the company trained an AI model that can generate many possible future timelines for a patient, then tell the doctor which outcomes are most likely, like what might happen during a hospital stay, or if the patient might end up in the emergency department in the next year. 
    • “Just as a large language model can be trained once and then used to generate different kinds of text, like an email or a poem, without being specifically trained on how to write either emails or poems, Epic’s “large medical model,” trained on all sorts of medical events and outcomes, could replace individual predictive medical algorithms. If the model, which Epic calls CoMET — the Cosmos Medical Event Transformer — can achieve performance similar to machine learning algorithms specifically trained to predict readmissions or asthma attacks, “that’s a breakthrough in how we can get risk prediction embedded into clinical care,” said Lindemann.
    • “This idea isn’t entirely new. Researchers like Arkadiusz Sitek at Massachusetts General Hospital have built models that predict future patient medical events before. But, Sitek told STAT, the scale of CoMET is impressive and suggests this approach will work in a large population. Epic trained and evaluated its model on 115 billion medical events from 118 million unique patient records collected from January 2012 to April 2025. The work was detailed in a preprint posted last week with Microsoft and Yale researchers.”
  • FIerce Healthcare informs us,
    • “Four hospitals are sending heart failure patients home with a virtual care support team under a newly unveiled collaboration between the American Heart Association (AHA) and remote chronic disease monitoring platform Cadence.
    • “The American Heart Association Connected Care pilot program aims to reduce 30-day readmissions by addressing “critical gaps in heart failure care” that occur after heart failure patients leave the hospital.
    • “It will see the participating hospitals integrate program referrals into their discharge workflows. Enrolled patients are given and taught to use connected vital sign monitors, which a Cadence virtual care team uses to provide ongoing clinical support, adjust treatments or direct the patient to an in-person provider if necessary.
    • “Almost one in four heart failure patients are readmitted to the hospital within 30 days of discharge, and fewer than a fifth receive post-discharge medical therapies in line with clinical guidelines, according to study data cited in the announcement.”
  • Beckers Hospital Review identifies “five new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 

Friday report

David Ermer–CDC, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, OPM, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Here is a link to OPM Director Scott Kupor’s latest blog post which is titled “Supporting Agencies through Change.” Thanks, Director Kupor for keeping us abreast of your activities.
  • The Wall Street Journal reports,
    • “President Trump removed former congressman Billy Long as the commissioner of the Internal Revenue Service after less than two months in the job.
    • “Long is being replaced on an interim basis by Treasury Secretary Scott Bessent, a senior White House official said. Bessent is the latest leader of a federal bureau that has gone through a series of commissioners since the start of Trump’s second term. Long was sworn in as the commissioner in June. 
    • “Long said Trump is appointing him as ambassador to Iceland.” 
  • The American Hospital Association News tells us,
    • “President Trump Aug. 7 issued an executive order, “Improving Oversight of Federal Grantmaking,” requiring government agencies to review new and discretionary grants to ensure grant funding advances the administration’s policy priorities. Among other provisions, the order restricts agencies from funding programs that “fund, promote, encourage, or facilitate: (A) racial preferences or other forms of racial discrimination … (B) denial by the grant recipient of the sex binary in humans … (C) illegal immigration; or (D) any other initiatives that compromise public safety or promote anti-American values.” The executive order also encourages agencies to award grants to institutions with lower indirect cost rates, to a broad range of recipients rather than repeat players, and to include clear benchmarks for measuring progress and success, as well as a commitment to Gold Standard Science. Within 30 days, agencies will update the terms and conditions for new and existing discretionary grants, which may permit immediate termination of existing grants.”
  • and
    • “The U.S. Departments of Labor, Health and Human Services, and the Treasury announced Aug. 7 that they are reconsidering the definition of short-term, limited-duration insurance through a formal rulemaking process. Until new rules are finalized, the departments will not prioritize enforcement actions against insurers that do not fully comply with the 2024 definition, including related notice requirements.
    • “HHS encourages states to adopt a similar enforcement approach and will not penalize states that either follow this federal approach or apply their definitions of STLDI under state law.”
  • STAT News informs us,
    • “Federal health officials are citing an extensive list of studies purported to document harms caused by messenger RNA vaccines as scientific justification for canceling hundreds of millions of dollars in investment in the technology. 
    • “Health secretary Robert F. Kennedy Jr. provided only a brief explanation for the decision earlier this week, arguing the mRNA vaccines are not effective and not as safe as alternatives, and referencing a review of scientific research on mRNA by “experts,” without identifying them. On Friday, when asked if the Department of Health and Human Services had a scientific justification, a spokesperson provided a link to a 181-page list of studies compiled by a number of people, including a current Trump administration adviser who served in the president’s first administration and was the subject of controversy for pushing unproven Covid-19 treatments. 
    • “The other contributors are people who have all previously criticized Covid-19 public health interventions, such as lockdowns and mRNA vaccines. 
    • “Taken together, the studies cited generally appear to advance research that has been disputed by other scientists, who argue that mRNA vaccines are overwhelmingly safe.”

From the Food and Drug Administration front,

  • MedPage Today relates,
    • “The FDA on Friday granted accelerated approval to zongertinib (Hernexeos) for non-squamous non-small cell lung cancer (NSCLC) patients harboring HER2 tyrosine kinase domain (TKD) activating mutations.
    • “Approval of the tyrosine kinase inhibitor stipulates use in adults with unresectable or metastatic disease who have received prior systemic therapy and was based on results from the open-label, phase Ia/Ib Beamion LUNG-1 study.”
  • Fierce Pharma adds,
    • “After telegraphing an investigation in November, the FDA has moved to restrict the use of bluebird bio’s gene therapy Skysona in certain patients.
    • “The FDA has updated Skysona’s indication, allowing it to be used only in patients who do not have an available human leukocyte antigen (HLA)-matched donor for stem cell transplant. The one-time therapy is approved to treat cerebral adrenoleukodystrophy (CALD), a rare inherited neurological disorder in which the accumulation of harmful fatty acids in the bloodstream damages the protective myelin sheath around nerve fibers.
    • “The FDA decided that Skysona should not be used in patients with alternative treatment options due to concerns of an increased risk of blood cancer.” * * *
    • “Skysona, with a list price of $3 million per treatment, recorded no sales in the first three months of 2025. Beta-thalassemia therapy Zynteglo saw its sales rise to $26.3 million during the first quarter, compared with $18.6 million a year ago. The sickle cell disease gene therapy Lyfgenia brought in $12.4 million in sales during the period, while Vertex’s rival CRISPR-based treatment Casgevy pulled in $14.2 million.” * * *
    • “As commercial progress of the three gene therapies fails to impress and a debt payment nears its due date, bluebird bio recently sold itself to Carlyle and SK Capital Partners for $49 million, or $5 per share, following some investor resistance to a previous lower offer price.”
  • Per an FDA news release,
    • “I [FDA Commissioner Marty Makary] am pleased to announce that the nationwide shortage of sodium chloride 0.9% injection products, a form of intravenous (IV) saline, has officially ended. This marks a significant milestone for public health and reinforces the FDA’s commitment to ensuring Americans have consistent access to life-saving medical products.” * * *
    • “For other IV fluids still in shortage, the FDA is working closely with manufacturers and will continue to monitor the supply to help ensure patients have access to the medicines they need. The availability of reliable medical products is essential to patient care and the overall resilience of our healthcare system. Addressing this shortage has been a top priority for the FDA and aligns with the Trump Administration’s broader commitment to strengthening the U.S. drug and medical supply chain.”
  • MedTech Dive lets us know,
    • “Boston Scientific has updated the instructions for use for products deployed in the implantation of its Watchman heart device to reduce a risk associated with 120 serious injuries and 17 deaths.
    • “The Food and Drug Administration released an early alert about the update Wednesday. Sharing information from Boston Scientific, the FDA said implanting the heart device without controlling the patient’s breathing increases the risk of an air bubble getting into the vascular system.
    • “Patients are only at risk during the implant procedure. People who have a previously implanted Watchman device do not need additional management.”

From the judicial front,

  • The Wall Street Journal reports,
    • “[The prescription drug manufacturer] GSK will receive $370 million from a U.S. patent settlement between CureVac and BioNTech regarding mRNA-based Covid-19 vaccines.
    • “GSK will get an upfront cash payment of $320 million and a 1% royalty on future U.S. sales of related mRNA vaccine products.
    • “The settlement does not affect GSK’s ongoing patent litigation against Pfizer and BioNTech in the U.S. or Europe.”
  • Healthcare Dive reports,
    • “Healthcare bankruptcies dropped to a three-year low during the second quarter of 2025, according to a new report from Gibbins Advisors. Just seven companies with at least $10 million in liabilities filed for Chapter 11 protections, compared with 14 in the same period last year.
    • “The restructuring advisory firm predicts there will be 16% fewer filings this year compared to 2024, as less large healthcare companies and providers declare bankruptcy.
    • “However, the dip may be short lived. Challenging market conditions, including impacts from cuts to Medicaid, could hit providers’ bottom lines as early as 2026, potentially spurring a new wave of bankruptcies, according to Gibbins.”

From the public health and medical research front,

  • The JAMA Network reports,
    • “Although the average life expectancy in the US remains lower than before the COVID-19 pandemic, 2023 marked the second consecutive year of improvement, according to a new report from the US Centers for Disease Control and Prevention (CDC). The authors attributed increases in life expectancy across all groups to decreased mortality from COVID-19, heart disease, unintentional injury, cancer, and diabetes.
    • “The overall average life expectancy rose by almost a year between 2022 and 2023, from 77.5 years to 78.4 years. During this period, male life expectancy increased from 74.8 to 75.8, whereas female life expectancy increased from 80.2 to 81.1. The average female life expectancy has exceeded that of males for decades, but the size of this gap continues to fluctuate.
    • “When analyzed by race and ethnicity, life expectancy increased for all populations in 2023. The American Indian and Alaska Native population experienced the greatest jump in mean life expectancy, a 2.3-year rise from 67.8 to 70.1.”
  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many areas of the country. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “COVID-19 laboratory percent positivity is increasing nationally. Emergency department visits for COVID-19 are increasing among all ages. COVID-19 wastewater activity levels and model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in most states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.”
  • The University of Minnesota CIDRAP adds,
    • “Amid a slow but steady rise in COVID activity, SARS-CoV-2 wastewater detections last week rose from the low to the moderate level, with the highest levels in the West, followed by the South, where detections in Louisiana are at the very high level, the US Centers for Disease Control and Prevention (CDC) said today in its latest weekly data updates. 
  • and
    • “Today in JAMA Network Open, University of Michigan-led research suggests that the US 2023-24 mRNA COVID-19 vaccines were cost-effective for people older than 65 years and in certain situations for younger adults.” * * *
  • and
    • “A survey conducted in emergency departments (EDs) in eight US cities found that 86% of adult respondents were not up to date with recommended vaccines, and half had not even heard of one or more of these vaccines.
    • “But the results of the survey, conducted by a team of US researchers and published yesterday in Morbidity and Mortality Weekly Report, also found that nearly half of the respondents said they would be willing to get a missing shot if they were offered one during their ED visit, and most of those participants said they’d be willing to get all of their missing vaccines.
    • “The authors of the study say the findings indicate that screening for vaccine coverage in EDs, which millions of Americans rely on as their only source of healthcare, could help boost recommended vaccine uptake in populations that have no primary care provider, such as immigrants, the uninsured, and homeless people.”
  • Per JAMA Network,
    • “The tau protein is known to be ubiquitous in neurons. Its naturally unfolded and highly flexible character allows it to interact with many components in neurons, especially microtubules in axons, helping to give these elements structure and promote growth. But when tau undergoes certain abnormal biochemical modifications such as phosphorylation, the pliable protein can lose function and can misfold and aggregate, leading to the development of neurofibrillary tangles and contributing to neurodegeneration. That’s why high levels of phosphorylated tau (p-tau) serve as one of the two main fluid biomarkers for Alzheimer disease (AD)—and why it surprised researchers when they recently discovered that infants have levels of p-tau far higher than people with AD.
    • “I was used to just hearing ‘p-tau is Alzheimer disease,’” said Fernando Gonzalez-Ortiz, MD, PhD, of the University of Gothenburg in Sweden who published the recent findings with a team of international collaborators. “In the Alzheimer disease field, we are sometimes very focused on thinking that p-tau is one of the bad guys, like tau phosphorylation is a completely pathological process, but that is not the case.”
    • “Using blood samples from umbilical cords and data from the Norwegian Dementia Disease Initiation cohort, Gonzalez-Ortiz and his colleagues found that healthy newborns had serum concentrations of p-tau217, an AD biomarker, around 10 pg/mL, nearly 3 times higher than those measured in patients with AD.
    • “The observation, which appeared this June in Brain Communications, led Gonzalez-Ortiz to a question: “What does it mean that the baby can handle these high concentrations of p-tau, but the adult brain can’t?” * * *
    • “Maybe in the future, therapies that target the clearance mechanisms and then enhance clearance, in combination with antiamyloid therapies, might lead to not only getting rid of amyloid, but also to preventing aggregation of tau,” Gonzalez-Ortiz said.
    • “His team’s next step is to differentiate the forms of p-tau present in the infant samples. Villain noted that it could also be useful to test the ratio between p-tau and total tau in the specimens to understand whether infants simply have more tau in their bloodstream.”
  • The University of Minnesota CIDRAP relates,
    • “A study of adults hospitalized with community-acquired pneumonia (CAP) in Georgia and Tennessee shows that a sizable fraction of infections was caused by Streptococcus pneumoniae, including serotypes covered by recently approved vaccines, researchers reported yesterday in JAMA Network Open.
    • “The prospective active-surveillance study, led by researchers at Vanderbilt University Medical Center, analyzed data on patients with clinical and radiologic evidence of CAP at three hospitals in Georgia and Tennessee from 2018 through 2022.” * * *
    • “The authors note that the annual incidence of 43 hospitalizations per 100,000 adults extrapolates to 114,800 US hospitalizations for pneumococcal CAP each year, based on current population estimates.
    • “Results of this study demonstrate that pneumococcal CAP remains an important cause of hospitalizations in the US,” they wrote. “With vaccination as the primary preventive measure for pneumococcal pneumonia, improved pneumococcal vaccines with appropriate vaccination coverage could lessen the burden of severe pneumonia on the US population, especially among older adults.” 
  • The Wall Street Journal reports,
    • “With a 33-year high in U.S. measles cases, researchers are reviving the search for treatments because of falling vaccination rates.
    • “Biotechs and universities are developing drugs for vulnerable, unvaccinated people.
    • “Monoclonal antibodies could offer immediate immunity, benefiting newborns, the immunocompromised and vaccine skeptics, scientists say.”
  • Per Health Day,
    • “Automatically mailing a stool test kit to people’s homes might be the best way to boost colon cancer screening among younger adults, a new study says.
    • “More 45- to 49-year-olds went ahead with cancer screening when they received an unsolicited stool test kit in the mail, rather than having to actively opt into screening or choose a test, researchers reported Aug. 4 in the Journal of the American Medical Association.
    • “Removing the need for patients to actively opt into screening can lead to better outcomes, particularly when trying to engage younger, generally healthy adults who may not yet perceive themselves at risk for cancer,” senior researcher Dr. Folasade May said in a news release. She’s a gastroenterologist and cancer prevention researcher at the UCLA Health Jonsson Comprehensive Cancer Center.”

From the U.S. healthcare business front,

  • Modern Healthcare interviews Debra Sukin, president and CEO of Texas Children’s, about the impressive financial turnaround at Texas Children’s, the largest pediatric hospital system in the U.S.
    • “How did you make a turnaround happen?
      • “We set out to best address the redesign of our organizational structure and realign the leadership team. We began to chart a course, entity by entity, department by department, in terms of how we were going to achieve our strategic goals.
      • “I’m a very data-driven leader. Organizing the way that we look at data, share data and use data to make decisions became absolutely paramount. We could easily see all our respective entities and where there were opportunities for improvements, and most importantly, identify how we were going to look beyond just expense management. 
      • “It was also about growth. It was about homing in on those opportunities and treating additional patients who needed our care.” 
  • Fierce Healthcare adds,
    • “Ascension [Healthcare, another large health system,] is taking a more intentional approach to innovations with a new unit dedicated to exploring, vetting and deploying tech tools across the major nonprofit health system.
    • “The organization announced this week the launch of its Clinical Innovation Institute (CII), which Ascension Chief Clinical Officer Thomas Aloia, M.D., describes as an “umbrella” aggregating and presiding over other innovation and tech programs that were already active within Ascension.
    • “We are absolutely not starting from scratch,” he said. “I would say we’re driving at about 60 miles per hour, and this organizational backing and support is going to take us to drive even faster.”
  • Healthcare Dive lets us know,
    • “Community Health Systems has found a new buyer for its three-hospital portfolio in Pennsylvania, approximately nine months after a proposed sale of the same facilities to WoodBridge Healthcare collapsed.
    • “Hospital turnaround firm Tenor Health Foundation signed a letter of intent to acquire Regional Hospital of Scranton, Moses Taylor Hospital and Wilkes-Barre General Hospital, collectively Commonwealth Health System, last week, a CHS spokesperson told Healthcare Dive. 
    • “The hospitals have been hemorrhaging money in recent fiscal years, according to reports filed to the Pennsylvania Health Care Cost Containment Council. Lawmakers have previously expressed worry that CHS could close the facilities if they could not find a buyer, reducing patients’ access to care.” 
  • Per Fierce Healthcare,
    • “In its first public earnings call after its initial public offering in June, virtual chronic disease provider Omada Health reported $61 million in revenue, up 49% year over year. The company has added 52% more members since Q2 2024 for a total of 752,000 members.
    • “Omada went public in early June, at a valuation of $1.1 billion, during what has turned out to be a worse-than-expected year for digital health exits due to economic uncertainty and tariffs. Hinge Health, a virtual MSK solution, also went public in May and reported its Q2 earnings on Wednesday.
    • “Omada ties remote monitoring devices with coaching and AI to help consumers control their chronic diseases. The company treats diabetes, hypertension, obesity and musculoskeletal conditions and leans on its multi-condition approach to differentiate itself from competitors.” 

Thursday report

David Ermer–CDC, COVID-19 vaccine, FDA, Generative AI, Medical / Rx research, Medicare, Mental health care, Obesity, Rx coverage, SDOH, U.S. Healthcare–

From Washington, DC,

  • MedPage Today tells us,
    • “HHS Secretary Robert F. Kennedy Jr. last month quietly endorsed recommendations from his handpicked vaccine advisors that everyone in the U.S. ages 6 months and older receive a flu shot for the upcoming season.” * * *
    • “ACIP reaffirms the recommendations for routine annual influenza vaccination of all persons aged ≥6 months who do not have contraindications for the 2025-2026 season,” the ACIP page states. “With no current CDC Director and pending confirmation of a new CDC Director, this recommendation was adopted by the HHS Secretary on July 22, 2025, and is now an official recommendation of the CDC.”
    • “A new CDC director, Susan Monarez, PhD, is now in place. * * *
    • “Another ACIP recommendation from the June meeting earned an endorsement Aug. 4 from Monarez. ACIP called for infants younger than 8 months who were born during or entering their first respiratory syncytial virus (RSV) season who are not protected by maternal vaccination to receive one dose of clesrovimab (Enflonsia)opens in a new tab or window. The monoclonal antibody joins a similar long-acting shot, nirsevimab (Beyfortus),opens in a new tab or window as an option for this population.”
  • Beckers Hospital Reviews lets us know six things about the tariffs that took effect today.
  • Federal News Network informs us,
    • “The Postal Service’s board of governors is urging its regulator not to put limits on its ability to set higher mail prices, after posting another multibillion-dollar quarterly net loss.
    • “USPS posted a $3.1 billion net loss for the third quarter of fiscal 2025 — a greater loss than the $2.5 billion net loss it saw for the same period last year.
    • “But Postmaster General David Steiner said USPS is “on the right path,” under a 10-year reform plan launched by his predecessor, former Postmaster General Louis DeJoy.
    • “The strategy is sound. Now we have to execute,” Steiner said during a public meeting of the USPS Board of Governors on Thursday. “But we can’t execute unless all of our team is working together. We all need to be rowing the oars in the same direction.”
  • Healthcare Dive relates,
    • “Amwell has extended a contract with the Defense Health Agency to support virtual care at the military health system, one of the company’s most significant growth initiatives, for another year, the telehealth vendor said Tuesday. 
    • “However, the deal cut out deployments for Amwell’s behavioral health and automated care programs “due to budget restrictions being broadly enforced by the Department of Defense,” CEO Ido Schoenberg said during a second quarter earnings call on Tuesday. 
    • “The contract change led the telehealth firm to revise its guidance for 2025. Amwell now expects revenue from $245 million to $250 million this year, down from its previous outlook of $250 million to $260 million.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration Aug. 7 announced a new program to help improve the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of drug manufacturing facilities in the U.S. The program, called FDA PreCheck, was created in response to a May 5 executive order, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” which directs the FDA to streamline and accelerate the development of domestic pharmaceutical manufacturing by eliminating unnecessary or duplicative regulations and improving inspection processes. 
    • “The program consists of a two-phase approach to facilitate new manufacturing facilities. The first provides manufacturers with more frequent FDA communication during stages such as facility design, construction and pre-production. The second focuses on streamlining development of the chemistry, manufacturing and controls section of the drug application through pre-application meetings and early feedback.” 
  • Per BioPharma Dive,
    • “The Food and Drug Administration on Thursday lifted its recommendation to pause use of Valenva’s chikungunya vaccine Ixchiq in older adults but added new warnings about the shot’s risks and limited who is eligible to receive it.
    • “The FDA’s action follows a similar move by the European Medicines Agency, which had paused use along similar lines as the FDA. However, the U.S. regulator’s changes to Ixchiq’s labeling appear likely to curtail how broadly its used in the future.
    • “Vaccination with Ixchiq is not advisable for most U.S. travelers. For most U.S. travelers, the risk of exposure to chikungunya is low,” the updated label says.”
  • Per MedTech Dive,
    • “Tandem Diabetes Care flagged a problem with certain t:slim X2 insulin pumps where a wiring issue with certain devices’ speakers can cause them to malfunction and stop delivering insulin. 
    • “Tandem said it has received reports of 700 adverse events and 59 injuries. There have been no reports of death. The problem, if not addressed, presents the risk of hyperglycemia in people with diabetes. The company said in a Thursday announcement that it has also alerted the Food and Drug Administration and regulators outside of the U.S. 
    • “The company sent a letter to customers in July. The FDA has not yet posted the device correction in its recall database.”
  • Fierce Pharma adds,
    • “When Jazz Pharmaceuticals’ incoming CEO Renee Gala takes the reins at the drugmaker next week, she’ll have a brand-new launch to manage.
    • “Wednesday, the FDA approved Jazz’s Modeyso (dordaviprone) for patients ages 1 and older with H3 K27M-mutant diffuse midline glioma who have progressive disease following prior therapy. The drug, picked up in the company’s $935 million buyout of Chimerix earlier this year, is the first systemic therapy for those with the aggressive brain cancer.”

From the judicial front,

  • Healthcare Dive reports,
    • “UnitedHealth and Amedisys have agreed to a settlement with the Department of Justice, clearing the path for their $3.3 billion merger to go through.
    • “The settlement, filed with the Maryland district court on Thursday, requires UnitedHealth and Amedisys to divest certain businesses in order to placate the DOJ’s concerns that the merger is anticompetitive. Amedisys has also agreed to pay a $1.1 million civil penalty to the U.S. for not fully complying with regulators during the merger review process.
    • “Regulators’ tentative greenlight of the multibillion-dollar deal is a win for UnitedHealth, which originally proposed plans to acquire the home health and hospice provider in 2023. However, the merger has been tied up in litigation after the DOJ and four states sued to block it in November.”
  • Per Fierce Healthcare,
    • “The drug price negotiation program has withstood another procedural effort in striking down one of the Inflation Reduction Act’s most significant provisions.
    • “In the U.S. Court of Appeals for the 6th Circuit, a panel of judges upheld (PDF) a lower court’s decision to dismiss the lawsuit.
    • “A judge dismissed the lawsuit last year, saying most of the plaintiffs lacked standing to bring the case, but the U.S. Chamber of Commerce was able to file a new suit. The U.S. Chamber could now appeal to the Supreme Court, reported The Hill.”
  • The Hill adds,
    • “Federal judges in Texas and Connecticut on Thursday ruled against arguments challenging the constitutionality of the Medicare Drug Price Negotiation Program, delivering two more blows to the pharmaceutical industry this week after an appeals court upheld the dismissal of a similar case.
    • “In Connecticut, the U.S. 2nd Circuit Court of Appeals upheld (PDF) a decision granted by U.S. District Judge Michael P. Shea last year against pharmaceutical company Boehringer Ingelheim. The company’s diabetes medication Jardiance was among the first 10 drugs chosen for Medicare negotiations, and two more of its products were chosen for the following round of negotiations.”
    • “In Texas, U.S. District Judge David Alan Ezra dismissed the lawsuit brought forward by the trade group PhRMA with prejudice, closing the case.”

From the public health and medical research,

  • The Wall Street Journal reports,
    • “Ultraprocessed foods make up the majority of calories Americans are eating, according to a report released Thursday by the federal government. But there are signs this consumption might be declining.
    • “Sandwiches, baked goods, salty snacks and other ultraprocessed foods accounted for 55% of the calories Americans age 1 and older consumed from August 2021 to August 2023, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics study. 
    • “That proportion is getting smaller. For adults, the mean percentage of calories consumed from ultraprocessed foods fell 3 percentage points to 53% since 2018 and for children and teens, it fell nearly 4 percentage points to 61.9%, the report found.
    • “Statistically, the decline is significant,” said Anne Williams, a senior service fellow at the CDC and lead author of the report. For adults consuming around 2,000 calories a day, the drop between the 2017 to 2018 figures and the latest report translates to around 60 fewer calories a day coming from ultraprocessed foods on average, said Williams.
    • “Ultraprocessed foods have been linked to an array of health issues, including obesity, Type 2 diabetes, cancer, cardiovascular disease and depression. There isn’t a set definition for ultraprocessed foods but researchers consider them foods made with ingredients not normally found in a home kitchen, including high-fructose corn syrup and emulsifiers such as soy lecithin.”
  • MedPage Today adds,
    • “Eating French fries multiple times a week was associated with a higher risk of type 2 diabetes, though this wasn’t the case for baked, boiled, or mashed potatoes, researchers said.
    • “For every increment of three servings weekly of French fries, the rate of type 2 diabetes increased by 20% (95% CI 1.12-1.28), and for every increment of three servings weekly of total potato, the rate increased by 5% (95% CI 1.02-1.08), reported Walter Willett, MD, of the Harvard T.H. Chan School of Public Health in Boston, and colleagues.
    • “However, consumption of combined baked, boiled, or mashed potatoes was not significantly associated with risk of type 2 diabetes (pooled HR 1.01, 95% CI 0.98-1.05), they noted in The BMJ.
    • “Importantly, our substitution analysis showed that replacing all forms of potatoes — especially fries — with whole grains was linked to a lower risk of type 2 diabetes, whereas swapping them for white rice was associated with the opposite effect,” co-author Seyed Mohammad Mousavi, PhD, also of the Harvard T.H. Chan School of Public Health, told MedPage Today. “This reinforces that it’s not just about the potato itself, it’s about how it’s prepared and what foods it’s replacing in the diet.”
  • Genetic Engineering and BioTechnology News reports,
    • “Parkinson’s disease (PD) is the second-most common neurodegenerative disorder after Alzheimer’s and is caused by the degeneration of dopamine-producing neurons in the brain, leading to motor dysfunction, such as tremors and slowed movements.  
    • “Vamsi Mootha, MD, institute member at the Broad Institute, explains that a striking epidemiological association exists between heavy smoking and lowered PD risk. As smoking causes elevated carbon monoxide exposure which disrupts oxygen delivery by hemoglobin, he speculates that a low oxygen state in the brain may offer an unexpected protective mechanism against this incurable neurological disease that affects more than 10 million people worldwide. 
    • “In a new study published in Nature Neuroscience titled, “Hypoxia ameliorates neurodegeneration and movement disorder in a mouse model of Parkinson’s disease,” Mootha’s lab has now shown that low oxygen environments, similar to the thin air found at Mont Blanc, which reaches an elevation of approximately 16,000 feet, can successfully recover neuron function and alleviate motor symptoms in mice with Parkinson’s-like disease.:
    • * * * “The fact that we actually saw some reversal of neurological damage is really exciting,” said Mootha in a public release. “It tells us that there is a window during which some neurons are dysfunctional but not yet dead—and that we can restore their function if we intervene early enough.”
  • Health Day relates,
    • “Vaccination with the updated COVID-19 mRNA vaccine containing the severe acute respiratory syndrome coronavirus-2 Omicron JN.1 lineage [the fall 2024 vaccine] was not associated with an increased risk for 29 adverse events, according to a study published online July 28 in JAMA Network Open.
    • “Niklas Worm Andersson, M.D., Ph.D., from Statens Serum Institut in Copenhagen, Denmark, and colleagues examined the association between vaccination with JN.1-containing vaccines and the risk for 29 serious adverse events adapted from prioritized lists of adverse events of special interest to COVID-19 vaccines. Outcome rates during the first 28 days after JN.1-containing vaccine administration (i.e., the risk period) were compared to outcome rates during the remaining period.”
  • Per MedPage Today,
    • “Superagers — a group of adults over age 80 with the memory capacity of much younger people — maintained good brain morphology, tended to be gregarious, and appeared to be resistant to neurofibrillary degeneration and resilient to its consequences, more than two decades of research showed.
    • “In contrast to neurotypical peers who had age-related brain shrinkage, this group had a region in the cingulate gyrus that was thicker than younger adults, reported Sandra Weintraub, PhD, of Northwestern University Feinberg School of Medicine in Chicago, and colleagues.
    • “Superagers also had fewer Alzheimer’s-related brain changes, greater size of entorhinal neurons, fewer inflammatory microglia in white matter, better preserved cholinergic innervation, and a greater density of evolutionarily progressive von Economo neurons, Weintraub and colleagues wrote in a perspective piece in Alzheimer’s & Dementia.
    • “No particular lifestyle was conducive to superaging, the researchers said. Some superagers appeared to follow all conceivable recommendations for a healthy life. Others did not eat well, enjoyed smoking and drinking, shunned exercise, suffered stressful life situations, and did not sleep well.
    • “Superagers also did not seem to be medically healthier than their peers and took similar medications as they did. However, the superager group was notably sociable, relishing extracurricular activities. Compared with their cognitively average peers, they rated their relationships with others more positively. On a self-reported questionnaire of personality traits, they tended to endorse high levels of extraversion.
    • “It wasn’t the social and lifestyles aspects of superaging that surprised the researchers; it was “really what we’ve found in their brains that’s been so earth-shattering for us,” Weintraub said in a statement.”

From the healthcare artificial intelligence front,

  • Fierce Healthcare informs us,
    • “OpenAI released its most advanced reasoning model, GPT-5, which it touts as its most useful model for healthcare.
    • “The application of ChatGPT for healthcare played a leading role in the company’s Summer Update meeting on Thursday, during which it did live demos of the upgraded model. 
    • “Sam Altman, CEO of OpenAI, said health is one of the top reasons consumers use ChatGPT, saying it “empowers you to be more in control of your healthcare journey.” The company prioritized improving its healthcare features for this version of the product, Altman said. 
    • “GPT-5 will be available on the free version of the ChatGPT app, which means more consumers could start to rely on the product for assistance in making treatment decisions, understanding test results and determining what questions they should ask their doctors in the clinic.” 
  • Beckers Health IT points out,
    • “Oakland, Calif.-based Kaiser Permanente has been experimenting with AI in its patient portal, increasing patient engagement and experience in the process.
    • “The health system’s Southern California Permanente Medical Group, headquartered in Pasadena, launched the Kaiser Permanente Intelligent Navigator for its 4.9 million patients in October. The platform allows patients to chat with AI via a text box to book appointments and connect with the care they need.
    • “Care is local, but at the same time it’s virtual and it’s become a global commodity,” Khang Nguyen, MD, assistant executive medical director for care transformation at Southern California Permanente Medical Group and chief medical officer of care navigation for the Permanente Federation, told Becker’s. “So patients are really expecting artificial intelligence to support healthcare in a way that is supporting other industries, in the sense that people are able to describe what they want versus being given choices.” * * *
    • “In a study that evaluated nearly 3 million patient encounters using the AI between October and March, the tool detected urgent medical issues with 97.7% accuracy and recommended appropriate care paths with 88.9% accuracy. Patients successfully booked appointments more than half the time, compared to the industry average of 30%. The portal’s patient satisfaction scores went up by about 9%.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly shares plunged about 14% in midday trading Thursday after the company reported less-than-stellar results of a new study of an experimental anti-obesity pill that is expected to become a blockbuster.
    • “The pill helped people lose up to about 12% of their body weight after more than a year of treatment. The results could clear the way for the shot alternative to be on the market next year, but the magnitude of weight loss fell short of Wall Street expectations.
    • “The drugmaker also raised its earnings outlook for the year after revenue surged in its latest quarter on continued demand for its weight-loss and diabetes treatments.”
    • “The Lilly pill, orforglipron, is expected to become a big seller if regulators approve it for sale. Morgan Stanley analysts had said that under their bull-case scenario, the drug’s use for both obesity and diabetes could generate annual sales of up to $40 billion by 2033.
    • “Yet the latest clinical-trial results may dent some of that enthusiasm. The magnitude of weight loss fell short of what some analysts were predicting: 13% to 15% or more. 
    • “The Lilly pill is one of two that could hit the market within the next year or so, ushering in a new chapter of the weight-loss drug boom. Novo Nordisk has applied for regulatory approval of an anti-obesity pill version of its Ozempic and Wegovy, which could become available by the end of this year.”
  • Modern Healthcare relates,
    • “Aetna will end nearly 90 Medicare Advantage plans across 34 states in 2026, the company notified third-party sellers this week.
    • “The CVS Health subsidiary’s financial performance has represented a bright spot in the Medicare Advantage market compared with competitors such as UnitedHealth Group. This month, CVS Health raised its annual earnings guidance amid a $2 billion turnaround plan. The company cut the second-most plans in 2025, after Humana.
    • “The majority of the Medicare Advantage plans Aetna plans to eliminate next year are PPOs. Beginning in September, Aetna will stop paying commissions to brokers that enroll new members in these plans, according to a notice the company distributed to brokers on Monday.”
  • and
    • “UPMC and GoHealth Urgent Care have rebranded 81 urgent care centers as part of a joint venture between the two organizations. 
    • “The centers span Pennsylvania and West Virginia and offer care for non-life-threatening ailments, including flu, fever, earaches, insect bites, sprains, simple fractures and cuts requiring stitches. They will also offer virtual care options and are staffed with UPMC clinicians, according to a Thursday news release.
    • “The centers were previously owned by UPMC, including sites it acquired last month from MedExpress, another urgent care provider. Financial details of the joint venture were not disclosed.” 
  • Beckers Payer Issues adds,
    • “As major insurers pull back on their Medicare Advantage offerings, health system-owned plans told Becker’s they’re eyeing an opportunity to regain ground ahead of the annual enrollment season.” * * *
    • “I do think it’s an opportunity. Over time, the playing field is going to level somewhat, which is going to be a challenge for the nationals. For the community health plans, I think it’s going to be a benefit,” Rob Hitchcock, president and CEO of Intermountain’s Select Health, said.
    • “What you want is a healthy mix. You do want the national players to be strong, but you also want the community health plans to be strong,” he added.
  • NFP, an Aon company, discusses pharmacy deserts.
    • “A pharmacy desert is more than just a rural problem. It’s any area, urban, suburban or rural, where people lack reasonable access to a pharmacy. That usually means:
      • “More than one mile away in urban areas.
      • “Two miles in suburban areas.
      • “10 miles in rural regions.
    • “However, distance isn’t the only factor. Even if a pharmacy technically exists nearby, lack of public transportation, limited hours or closures of independent stores can make access nearly impossible, particularly for lower-income communities or those with mobility challenges.” * * *
    • “Pharmacy deserts are growing, and they have real consequences for employee health, equity and cost. While benefit consultants cannot control the closures, clients can guide their employees toward solutions that help their people stay healthy and protected, no matter where they live.”

Thursday report

David Ermer–CDC, CMS, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, SCOTUS, SDOH, U.S. Healthcare–

From Washington, DC,

  • On July 2, 2025, the U.S. Office of Personnel Management’s Inspector General issued a Flash Report titled “OPM’s Postal Service Health Benefits Program: Critical Resource Issues,” which Govexec discusses here. The FEHBlog believes and has repeatedly stated that the eligibility program for FEHB and PSHB could be vastly improved if OPM used the widely adopted HIPAA 820 Electronic Enrollment Roster Transaction. The HIPAA 820 transaction would allow carriers to promptly and systematically identify situations where no, or an incorrect, premium payments.
  • The American Hospital Association News reports,
    • Senior leaders from the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response, along with White House representatives, visited pharmaceutical company Phlow Corp.’s new production system that manufactures key starting materials, active pharmaceutical ingredients and finished dose forms for 15 medicines used in the U.S. health system. Phlow laboratories and manufacturing facilities are located in the Mid-Atlantic, keeping the complete manufacturing cycle contained in one region. HHS-ASPR and Phlow have collaborated since May 2020 to bring pharmaceutical supply chains into the U.S. and reduce dependency on foreign countries. China and India, for example, account for more than 70% of APIs and KSMs imported to the United States. 
  • Per an HHS news release,
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today unveiled its groundbreaking Functional Repair of Neocortical Tissue (FRONT) program, a transformative initiative to restore brain function and position the U.S. as the global leader in brain repair technology. The FRONT program aligns directly with the priorities set by President Trump and Secretary Robert F. Kennedy, Jr., demonstrating a strong commitment to innovation, public health, and the economic well-being of the American people.
    • “Millions of Americans are living with the damage caused by strokes and traumatic brain injuries. Current treatments are not enough. ARPA-H hopes to deploy regenerative medicine to transform the treatment of neurological diseases and relieve the suffering,” said HHS Deputy Secretary Jim O’Neill.
    • ‘The neocortex, the largest part of the brain, is critical for sensory perception, motor control, and decision-making. Damage to this area—due to conditions like stroke, traumatic injury, or neurodegeneration, such as Alzheimer’s disease—has long led to irreversible damage, leaving individuals dependent on costly therapies or caregivers. The FRONT program aims to change that, using cutting-edge neurodevelopmental principles and stem cell technology to regenerate brain tissue and restore lost functions.”
  • The Brown & Brown actuarial consulting firm helpfully summarizes here the employee benefit provisions of the One Big Beautiful Act.
  • CMS announced resources and flexibilities to address the public health emergency in the State of Texas.

From the judicial front,

  • Govexec reports,
    • “The federal judge who temporarily blocked the Trump administration from implementing mass layoffs before the Supreme Court intervened has suggested she still plans to litigate the legality of individual agency workforce reduction plans. 
    • “The high court this week struck down the injunction that impacted most major agencies, allowing the administration to move forward with widespread RIFs. New layoff notices have not gone out since that decision on Tuesday, but they are expected imminently at several agencies. The court made clear, however, that its ruling applied only to the overall finding of President Trump’s capacity to order staffing cuts and not to the legality of individual agency RIF plans. 
    • “The content of those individual plans “thus remains squarely at issue in this case,” California-based U.S. District Judge Susan Illston, whose original decision led to the RIF pause, said in a new order Wednesday evening.” * * *
    • “Attorneys for the Trump administration previously noted it had 40 RIF actions underway at 17 agencies that were paused by Illston’s injunction. The federal employee unions, local governments and non-profit organizations that originally brought the lawsuit issued an “urgent request” following the Supreme Court decision asking the administration to submit those plans to the court for a decision on their legality. Illston ordered the administration to reply to that request by Monday and suggested she agreed the plans should be submitted for examination. 
    • “The administration previously argued it could not release them because they were predecisional and subject to executive privilege, but the judge on Wednesday suggested that final decisions on the RIFs must have been made if her injunction had paused them from taking effect. She added the court was “not inclined” to allow for significant redactions.” 
    • Here is a Dropbox link to the Court’s order.
  • The New York Times adds,
    • “A federal judge on Thursday blocked the Trump administration from enforcing a contentious executive order ending birthright citizenship after certifying a lawsuit as a class action, effectively the only way he could impose such a far-reaching limit after a Supreme Court ruling last month.
    • “Ruling from the bench, Judge Joseph N. Laplante of the U.S. District Court for the District of New Hampshire said his decision applied nationwide to babies who would have been subject to the executive order, which included the children of undocumented parents and those born to academics in the United States on student visas, on or after Feb. 20.
    • “The Trump administration has fought to challenge the longstanding law, laid out in the Constitution, that people born in the United States are automatically citizens, regardless of their parents’ immigration status. Judge Laplante’s order reignites a legal standoff that has been underway since the beginning of President Trump’s second term.
    • “The judge, an appointee of President George W. Bush, issued a written order formalizing the ruling on Thursday morning. He also paused his order for seven days, allowing time for an appeal.”

From the Food and Drug Administration front

  • BioPharma Dive lets us know,
    • The Food and Drug Administration on Thursday granted full approval for Moderna’s COVID-19 vaccine Spikevax in children aged 6 months through 11 years who are at an increased risk for COVID disease.
    • The shot was previously available for these individuals under emergency use authorization. The company said it expects to have an updated version of its shot available in time for the 2025-2026 respiratory disease season.
    • In May, Health and Human Services Secretary Robert F. Kennedy Jr. announced that COVID vaccines would no longer be recommended for healthy children and pregnant people. The Centers for Disease Control and Prevention currently recommends shared clinical decision-making for healthy children.

From the public health and medical research front,

  • The American Journal of Managed Care tells us,
    • “Ovarian cancer mortality rates have declined, but disparities exist across age, race, and geographic regions, with older women and non-Hispanic White women having the highest rates.
    • “Despite treatment advances, late-stage diagnosis remains a barrier due to the lack of routine screening, resulting in low survival rates for advanced-stage ovarian cancer.
    • “Geographic disparities show the Northeast with the highest mortality rates, while both metropolitan and non-metropolitan areas experienced declines, with metropolitan areas showing a steeper decline.
    • “The study’s limitations include the absence of individual-level data on lifestyle factors, tumor histology, and treatment protocols, hindering causal conclusions.”
  • Radiology Business points out,
    • “Shared decision-making visits significantly boost patients’ adherence to low-dose CT lung cancer screening, according to new research published Wednesday. 
    • “Numerous studies have explored poor uptake of LDCT, with rates as low as 18% among eligible individuals.
    • “Researchers with the American College of Radiology’s Neiman Policy Institute recently explored whether “shared decision-making” visits—required by Medicare as part of CT referrals—can boost screening adherence. They found a clear correlation, with imaging rates nearly 27% higher than those who did not meet with their primary care provider to discuss their risks and benefits of lung cancer screening, according to the study results, published in Chest. 
    • “Shared decision-making is more than just a billing requirement—it’s a valuable opportunity to engage patients in informed, personalized discussions about screening,” study author Farouk Dako, MD, MPH, associate professor of radiology, with the Perelman School of Medicine in Philadelphia, said in a July 9 announcement from the Policy Institute. “There is an opportunity to leverage this new evidence in national campaigns to raise awareness of lung screening and the importance of prioritizing SDM in routine clinical care to improve early detection and outcomes for one of the deadliest forms of cancer.” 
  • Gen Edge relates,
    • Scientists have produced the first detailed characterization of the changes that weight loss (WL) causes in human adipose tissue (AT) by analyzing hundreds of thousands of cells from morbidly obese individuals undergoing weight loss surgery. They found a range of positive effects, including clearing out damaged, aging cells and increased metabolism of harmful fats.
    • The team, headed by William R Scott, PhD, at the MRC Laboratory of Medical Sciences and at Imperial College London, analyzed gene expression in more than 170,000 cells that made up the fat tissue samples from 70 people. They generated a high-resolution single-nucleus and spatial atlas of human AT in people with extreme obesity undergoing therapeutic weight loss and in healthy lean counterparts. The investigators suggest that their findings could help scientists better understand how weight loss leads to health improvements at a molecular level, which in the future could help to inform the development of therapies for diseases such as type 2 diabetes.
    • “We’ve known for a long time that weight loss is one of the best ways to treat the complications of obesity, such as diabetes, but we haven’t fully understood why,” Scott said. “This study provides a detailed map of what may actually be driving some of these health benefits at a tissue and cellular level.”
    • “Scott and colleagues reported on the study in Nature, in a paper titled “Selective remodeling of the adipose niche in obesity and weight loss,” in which they stated, “This rich representation of human AT biology and pathophysiology offers a valuable resource for mechanistic and therapeutic exploration.”
  • The New York Times considers “Just How Harmful Is Vaping? More Evidence Is Emerging. A new study that found high levels of heavy metals in popular nicotine vapes adds to concerns about the products.”
  • Per Fierce Pharma,
    • “Pfizer and Astellas are underlining the benefits of Xtandi as part of a combination therapy for certain patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with an overall survival win.
    • “The new data come from the companies’ phase 3 Embark study, which in 2023 led to the FDA approval of Xtandi in patients with nmHSPC with biochemical recurrence (BCR) at high risk of metastasis.
    • “In the trial, Xtandi was studied as a single agent and in combination with leuprolide against placebo and leuprolide. For the trial’s primary endpoint, the Xtandi combo delivered a statistically significant improvement in metastasis-free survival compared with placebo and leuprolide.
    • “At the time, the trial’s overall survival data were mature.
    • “Now, Xtandi plus leuprolide has proved it can, in fact, extend the lives of these patients, demonstrating a “statistically significant and clinically meaningful improvement” in overall survival, Pfizer announced in a July 10 press release.”

From the U.S. healthcare business front,

  • The WTW consulting firm discusses how to strategically manage health and wellness costs in 2025.
  • Healthcare Dive reports,
    • “UnitedHealth has tapped longtime insurance executive Mike Cotton to lead its Medicaid business, filling a role that has stood empty since the company reshuffled its executive team earlier this year, the company confirmed to Healthcare Dive.
    • “Meanwhile, Bobby Hunter, who leads the healthcare juggernaut’s Medicare division, is stepping up as CEO of government programs, with oversight of both Medicare and Medicaid.”
  • Fierce Healthcare notes,
    • “Health Care Service Corporation is launching the HealthSpring brand for its Medicare products after closing the deal to acquire Cigna’s Medicare plans.
    • “Plans under the HealthSpring label were included in the deal, and HCSC said in an announcement that it refreshed the brand identity for a national rollout. The insurer will offer its first plans under the HealthSpring umbrella later this year, pending needed regulatory approvals.”
  • Fierce Biotech informs us,
    • “AbbVie is paying Ichnos Glenmark Innovation (IGI) $700 million upfront for a next-generation rival to Johnson & Johnson’s Tecvayli, positioning the Big Pharma to advance a new option for multiple myeloma patients.
    • “The deal gives AbbVie rights to ISB 2001, a trispecific antibody that targets CD38, BCMA and CD3. J&J’s Tecvayli, Pfizer’s Elrexfio and Regeneron’s Lynozyfic hit BCMA and CD3. Adding CD38 to the mix could boost binding to tumor cells with low expression of BCMA and stop cancers from becoming resistant by downregulating the antigens.
    • “AbbVie has placed a high price on that potential, coughing up $700 million for a phase 1 candidate and offering up to $1.225 billion in development regulatory, and commercial milestones. In return, IGI has granted AbbVie rights to the trispecific across North America, Europe, Japan and Greater China.”

Weekend update

David Ermer–Congress, COVID-19 vaccine, FDA, Medical / Rx research, OPM, Telehealth, U.S. Healthcare–

From Washington, DC

  • Roll Call tells us what actions the Houses of Congress are expected to take this week.
  • The Supreme Court begins the last month of its October 2024 term this week. The Court plans to release new opinions on Thursday. SCOTUSblog keeps track of the Court’s decisions here.
  • The Trump Administration released its detailed FY 2026 budget proposal last Friday. The proposal includes the three traditional FEHB / PSHB appropriations provisions
    • The contraceptive coverage mandate (Sec. 721)
    • The abortion coverage restriction / Hyde amendment (Secs. 611, 612)
    • The prohibition on application of full Cost Accounting Standard coverage to FEHB carriers (Sec. 609)
  • The proposal adds the following new provision (Sec. 743)
    • “None of the funds made available by this Act or any other Act may be provided for insurance plans in the Federal Employees Health Benefits program to cover the cost of surgical procedures or puberty blockers or hormone therapy for the purpose of gender affirming care.”
  • Govexec adds,
    • The proposal [Sec. 743] comes just a week after House Republicans made a late change to their budget reconciliation package, which initially would have barred Medicaid or CHIP funds going toward pediatric gender affirming care, to ban federal funds going to those treatments for adults as well.
  • BioPharma Dive reports,
    • “The Food and Drug Administration has granted an approval to Moderna’s next-generation COVID-19 vaccine, but with limits that will restrict use to older adults and people with preexisting health conditions. The OK is the first since agency leadership rolled out new guidelines for COVID shot approvals.
    • The new vaccine, which Moderna will sell as mNexspike, is cleared for healthy adults 65 years and older and for individuals aged between 12 years and 64 years with one or more underlying “risk factors,” the company said Saturday.

From the judicial front,

  • Govexec tells us,
    • “An appeals court has allowed a pause on all layoffs at most major federal agencies to remain in place, rejecting the Trump administration’s bid to block a lower court’s injunction and likely sending the matter to the Supreme Court for final adjudication. 
    • “A ruling preventing most reductions in force and agency reorganizations from taking place will continue indefinitely after the U.S. Court of Appeals for the Ninth Circuit ruled—in a 2-1 decision—in favor of the unions, municipalities and advocacy groups that sued over the workforce reduction plans. The Trump administration brought the case on an emergency basis, seeking a stay of a district court ruling that had found President Trump likely acted outside his legal and constitutional powers.”
    • Here’s a link to the Court’s opinion.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “When facing down a cancer diagnosis, patients often ask: What can I do to help my own odds? 
    • “The answer, data increasingly shows, is to go back to the basics: exercise and a good diet. 
    • “A structured exercise program with a trainer helped colorectal cancer patients lower their risks of death and cancer recurrence after treatment, according to a study released Sunday at the American Society of Clinical Oncology’s annual conference in Chicago and published in the New England Journal of Medicine. 
    • “The study spanned more than a decade and is the first to answer conclusively in a controlled trial whether physical activity can improve cancer-related survival, the study’s authors said. Patients in the program had a 37% lower risk of death after eight years, compared with patients who only received educational information on exercise.”
  • The New York Times informs us,
    • “Breast cancer patients whose tumors have spread to other parts of their bodies live from scan to scan. Is their treatment working? Or will they learn their cancer is growing again?
    • “But a new study sponsored by the drug company AstraZeneca showed that there is an alternative: Instead of waiting for a scan to show that a cancer is growing, it’s possible to find early signs that the cancer is resisting the drugs that were controlling it.
    • “To do that, researchers used a blood test to find mutations in cancer cells that let the tumors defy standard treatments. Early detection allowed patients to be switched to a different drug that overcomes the mutated cancer. The result was to keep the cancers in check longer and allow patients to have more than an extra year without deteriorating quality of life.
    • “The study was reported Sunday at the annual meeting of the American Society of Clinical Oncology (ASCO) and published in The New England Journal of Medicine.”
  • Also from ASCO, Biopharma Dive relates,
    • “AstraZeneca and Daiichi Sankyo’s targeted cancer medicine Enhertu helped participants in a late-stage clinical trial with a type of advanced gastric cancer live longer than those who received a commonly prescribed, two-drug regimen involving chemotherapy.
    • “The finding, detailed Saturday at the American Society of Clinical Oncology’s annual meeting, gives physicians a clearer choice for when patients’ disease progresses after initial treatment.
    • “Data from the trial should also shore up AstraZeneca and Daiichi’s market position. Enhertu already won Food and Drug Administration approval for gastric cancer that’s positive for a protein called HER2 following first-line treatment with Herceptin, an older HER2-targeting medicine.”
  • The Washington Post lets us know about “four ways women are physically stronger than men. Strength is associated with brute force, but female bodies excel in resilience and other key areas.”
  • The New York Times Well suggests ten workouts that you can take on vacation.

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “Could you use some discreet help with birth control from a $14.99-a-month period-tracking app?
    • “How about a hands-free, wearable breast pump, for $549; a $299 wristband to soothe hot flashes; or an extra-slim, temperature-neutral, LED-lit speculum to bring to gynecologists’ appointments — part of a $125 kit including “comfy socks”?
    • “These products and more are part of a fast-growing industry known as “femtech” — high-tech solutions for women’s health needs — whose many female founders say they’re tackling age-old inequities.
    • “Investors have jumped in, growing the market from $40.2 billion in 2020 to a projected $75 billion this year. And that’s just for starters: A “ghost market” of strategies to address “profoundly underserved women’s health needs” could reap up to $360 billion, a venture capital firm reported in March.
    • “Many areas of women’s health — like menstrual pain, endometriosis, polycystic ovarian syndrome, preeclampsia, and menopause — have been overlooked for so long by traditional medicine that women have had to take these problems into their own hands and innovate,” said Elizabeth Gazda, CEO of Embr Labs, which makes the wristband to treat hot flashes. “And because these innovations are occurring at a time of expanding technological ability, with cloud computing and ubiquitous smartphone adoption, women’s health is now leapfrogging men’s health.”
  • In the same vein, Fortune Well interviews Midi Health’s CEO Joanne Strober.
    • The menopause care company, launched in 2021, has helped 200,000 women get support and care to manage menopause and is the fastest-growing virtual health care company for women in midlife. But CEO Joanna Strober admits that many women left their appointments wanting more guidance: How much fiber should I be eating? What’s the proper combination of melatonin and magnesium to improve sleep? How do I prevent cognitive decline?
    • Now, Strober hopes to give them an answer—and appeal to younger women. 
    • In an exclusive interview with Fortune, Strober shared the expansion plans for Midi Health with the launch of AgeWell, which she calls a “longevity roadmap grounded in women’s hormonal health” to improve women’s “strength” and “vitality.” 

Friday Report

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, NCQA, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash
  • The University of Minnesota’s CIDRAP tells us,
    • “The Centers for Disease Control and Prevention (CDC) yesterday updated its childhood immunization schedule with a revised recommendation on COVID-19 vaccines for healthy children.
    • “The changes partly reflect a new position on COVID vaccine recommendations for healthy children announced earlier in the week by Department of Health and Human Services Secretary Robert F. Kennedy Jr., though they do not go as far as Kennedy had suggested.
    • “The CDC childhood immunization schedule now says that healthy children ages 6 months to 17 years, when the parent expresses a desire for their child to vaccinated, “may receive COVID-19 vaccination, informed by the clinical judgement of a healthcare provider and personal preference and circumstances.” Previously, the agency had recommended COVID-19 vaccines for healthy children ages 6 months and older, based on the recommendation of the CDC’s Advisory Committee on Immunization Practices.” * * *
    • “[A]ccording to the CDC, shared clinical decision-making recommendations on the immunization schedule are required to be covered by private insurers [with no cost sharing when provided in-network] under the Affordable Care Act.
    • “The CDC is still recommending COVID vaccination for children ages 6 months to 17 years who are moderately or severely immunocompromised.”
  • Govexec informs us,
    • “The White House on Friday told the government’s top watchdog it will only cooperate when doing so does not impede its ability to carry out President Trump’s agenda, reigniting a feud that traces back to the president’s first term in office. 
    • “The letter, from Office of Management and Budget General Counsel Mark Paoletta to the Government Accountability Office, follows the watchdog last week finding the Trump administration violated federal spending laws by withholding money appropriated by Congress. Paoletta denied that the administration has flouted the Impoundment Control Act, the law that prohibits the executive branch from withholding congressionally appropriated funds for policy reasons. 
    • “The OMB official criticized GAO for asking too many questions of the White House, including the dozens of probes the watchdog has opened into potential illegal impoundments. Paoletta noted that GAO has around 50 “open engagements” with the budget office. 
    • “Not only does GAO exceed its statutory authority when it unhelpfully injects itself into an agency’s implementation of a program, GAO also hampers the Executive Branch’s ability to carry out its statutory mandates,” Paoletta said in the letter, which was first reported by The Washington Post. He added the legislative branch agency often attempts to substitute its “policy views for those of the president.” 
  • The American Medical Association News lets us know,
    • “The Government Accountability Office May 29 released a report recommending the Centers for Medicare & Medicaid Services target behavioral health services when auditing Medicare Advantage plans’ use of prior authorization. CMS said it currently does not target behavioral health services because they make up a small percentage of MA services, the report said.     
    • “The report describes selected MA organizations’ prior authorization requirements and use of internal coverage criteria for prior authorization decisions on behavioral health services. It also examines CMS’ oversight of the use of internal coverage criteria, among other issues. GAO said that CMS “would take the recommendation under advisement in the future.” 

In Food and Drug Administration news,

  • Per Healio,
    • “The FDA approved Tryptyr to treat the signs and symptoms of dry eye disease, according to a press release from Alcon.” * * *
    • “Many of my patients continue to face frustrating challenges with dry eye management, and there is a clear need for additional treatment options,” Marjan Farid, MD, professor of ophthalmology at the University of California, Irvine, said in the release. “Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of dry eye disease.” * * *
    • “Alcon expects a third quarter launch for Tryptyr in the U.S.”
  • Per HCPLive,
    • “The US Food and Drug Administration (FDA) has approved hydrocortisone (KHINDIVI) oral solution as a replacement therapy in pediatric patients aged 5 years and older with adrenocortical insufficiency.1
    • “Announced by Eton Pharmaceuticals on May 28, 2025, this approval marked the first FDA-approved oral solution formulation of hydrocortisone, designed to address administration and dosing accuracy in patients who may have difficulty swallowing pills or special administration needs.” * * *
    • “Adrenal insufficiency is a rare, serious condition characterized by decreased production of aldosterone and cortisol due to reduced adrenal gland function. It can present acutely in an adrenal crisis or chronically, and if not recognized, can lead to very high morbidity and mortality.2 In the release, Eton Pharmaceuticals estimated that more than 5,000 adrenal insufficiency patients are present in the US between the ages of 5 and 17.”

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, emergency department visits, and laboratory percent positivity are at very low levels.
      • Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home.
    • Influenza
    • RSV
      • RSV activity has declined to low levels.
  • The University of Minnesota’s CIDRAP adds,
    • “The US Centers for Disease Control and Prevention (CDC) in its weekly update today reported 42 measles cases, some tied to a large outbreak centered in West Texas and others linked to instances of community transmission or travel to other states or countries, lifting the nation’s total to 1,088 infections.
    • “Two more states reported their first cases this week, Iowa and Nebraska, putting the number of affected jurisdictions at 33. The number of outbreaks remained at 14, and 90% of cases are linked to outbreaks.” * * *
    • “The Texas Department of State Health Services (TDSHS) today reported 9 more cases in the West Texas outbreak, putting the total since January at 738. Though 35 counties have reported cases linked to the outbreak, only 7 still have ongoing transmission. 
    • “Like other states, Texas also continues to record measles cases from various sources that apparently aren’t linked to the larger outbreak, and today officials reported 8 more such infections, lifting that total to 32. 
    • “A few other states have reported cases linked to West Texas activity, but no new illnesses were reported in New Mexico or Oklahoma. On May 28, Kansas reported a total of 64 cases from 11 counties, 59 of them linked to an outbreak in the southwestern part of the state.’
  • CBS News reports,
    • “Hormel Foods Corporation is recalling over 256,000 pounds of canned beef stew nationwide due to potential contamination with wood fragments, according to federal health officials.
    • “In a recall notice posted Wednesday [May 28], the U.S. Department of Agriculture’s Food Safety and Inspection Service said the 20-oz. metal cans containing “Dinty Moore Beef Stew” were shipped to retail locations nationwide.
    • “The recalled products have a “FEB 2028” best by date, lot code “T02045” and establishment number “EST 199G” printed on the can. 
    • “The problem was discovered after the establishment notified FSIS that they had received three consumer complaints reporting pieces of wood in the beef stew product,” the notice read. 
    • “So far, there have been no confirmed reports of injury.”
  • The American Medical Association lets us know “what doctors wish patients knew about improving eye health.”
  • Health Day points out,
    • “Among U.S. youth, overdose deaths attributable to synthetic opioids alone are increasingly predominant, according to a study published online May 20 in Pediatrics.
    • “Megan Miller, M.P.H., from the New York University Grossman School of Medicine in New York City, and colleagues examined trends in overdose deaths involving combinations of synthetic opioids with benzodiazepine, cocaine, heroin, prescription opioids, and other stimulants. Findings were based on U.S. youth aged 15 to 24 years from 2018 to 2022 using the National Vital Statistics System multiple cause of death datasets.
    • “The researchers found that between 2018 and 2022, overdose death counts increased from 4,652 to 6,723 (10.85 to 15.16 per 100,000), with a slight decrease between 2021 and 2022. Deaths involving synthetic opioids only showed the largest increases (1.8 to 4.8 deaths per 100,000). Regardless of race, ethnicity, or sex, fatal synthetic opioid-only overdose rates were higher than polydrug overdose rates involving synthetic opioids since 2020. In 2022, rates of synthetic-only overdose deaths were 2.49- and 2.15-times higher among male versus female youth and among those aged 20 to 24 versus 15 to 19 years, respectively.”
  • and
    • “Heart disease, strokes and diabetes contribute to many dementia cases in the United States, but the risk is not equal everywhere, a new study says.
    • “Overall, more than a third (37%) of U.S. dementia cases are linked to eight conditions: diabetes, heart failure, atrial fibrillation, coronary artery disease, heart attack, stroke, high blood pressure and high cholesterol, researchers found.
    • “The South has the strongest link between these diseases and dementia, researchers reported recently in the journal Alzheimer’s & Dementia.
    • “A substantial number of dementia cases could be eliminated by mitigating modifiable cardiometabolic risk factors, especially in U.S. counties with a high risk of dementia attributed to these risk factors,” senior researcher Dr. Brad Racette said in a news release. He’s chair of neurology at Barrow Neurological Institute in Phoenix.”
  • Per a National Institutes of Health news release,
    • “A research team funded by the National Institutes of Health (NIH) has identified a diagnostic aid that has the potential to accurately predict the recurrence of diabetic foot ulcers that appear to be fully healed. By measuring the skin’s barrier function through a process known as trans-epidermal water loss, or TEWL, scientists were able to determine which wounds were more likely to reopen. TEWL measurements are a major factor in burn care, where deep layers of the skin are often damaged. The findings suggest that full restoration of skin barrier function should be incorporated into existing wound treatment standards to ensure complete wound closure and to better identify patients at risk of wound recurrence.
    • “This study is an important initial step to give clinicians treating diabetic foot ulcers a reliable diagnostic aid for the first time to assess an individual’s risk of ulcer recurrence,” said Teresa Jones, M.D. program director for the Division of Diabetes, Endocrinology, & Metabolic Diseases at NIH’s National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK). “Foot ulcers are such a confounding issue with diabetes and being able to determine which wounds are at highest risk for recurrence could save many lives and limbs.”  
  • NCQA, writing in LinkedIn, tells us,
    • The use of peer support is a growing trend for populations affected by mental health and substance use disorders. Peers—both paid and volunteer—have many of the same lived experiences as the people they serve, and can help them navigate the health care system, access treatment and overcome barriers to recovery.
    • Peers are another avenue of support in the behavioral care system—their shared experience related to mental health, addiction and recovery helps them build trust relationships. Many studies show the benefits of peer support: decreased days in inpatient care, increased engagement in outpatient treatment, reduced readmission rates and lower relapse rates.
    • “There’s a stigma associated with receiving mental health and substance use treatment,” says Chrissy Craig, MSPH, NCQA’s Senior Health Care Analyst. “Because of their lived experience, peers can connect with people who may not be ready to engage in traditional treatment approaches. They can build trust and encourage individuals to get the help they need.”
    • Recognizing the importance of peer support, NCQA has added it as an option for follow-up care in four HEDIS® measures:
      • Follow-Up After Emergency Department Visit for Substance Use (FUA).
      • Follow-Up After Hospitalization for Mental Illness (FUH).
      • Follow-Up After Emergency Department Visit for Mental Illness (FUM).
      • Follow-Up After High-Intensity Care for Substance Use Disorder (FUI) (MY 2026).
  • Per Health Leaders Media,
    • “An AI tool that can detect inflammation in the coronary artery could help clinicians diagnose heart disease much earlier, even decades before the patient shows any outward signs of distress.
    • “CaRi-Heart Technology, developed by Connecticut-based Caristo Diagnostics, was recently given its own Category III CPT code by the American Medical Association’s CPT Editorial Panel, an important step in the path to adoption after FDA approval and, just as important, payer reimbursement. The technology has also shown promising results in trials conducted in 2024 at five National Health Service hospitals in the UK, where reports indicate more than half of patients analyzed by the AI tool had their treatments changed.
    • “To clinicians, the tool could be a critical step forward in the diagnosis and treatment of heart disease, the leading cause of death in the country.”
  • The Wall Street Journal reports,
    • “Sanofi and Regeneron’s respiratory drug, itepekimab, showed mixed results in late-stage trials for COPD.
    • “One trial saw a statistically significant 27% reduction, while the other missed its primary goal with only a 2% reduction.
    • “Sanofi shares fell 7% and Regeneron shares dropped 12% after the results; future steps will be discussed with regulators.”
  • Per BioPharma Dive,
    • “A dual-acting drug developed by Summit Therapeutics and Akeso delayed tumor progression in a Phase 3 lung cancer trial but didn’t extend survival, complicating its potential path to approval in the U.S.
    • “When administered alongside chemotherapy, the drug, known as ivonescimab, reduced the risk of death or disease progression by 48% compared to chemotherapy alone in patients whose non-small cell lung cancer has a mutation in a gene called EGFR. However, a 21% reduction in death risk, specifically, didn’t meet the threshold for statistical significance, Summit said in a statement Friday.
    • “Summit intends to seek Food and Drug Administration approval based on the study results. Yet in its statement, the company indicated the timing of a filing is uncertain given the agency has made clear that a survival benefit is “necessary” to support a submission.”

Fromm the U.S. healthcare business front,

  • The actuarial consulting firm, Milliman, announced on May 27,
    • the release of the 2025 Milliman Medical Index (MMI), which measures healthcare costs for Americans covered by a typical employer-sponsored health insurance plan. Healthcare costs for the average person increased 6.7% in 2025, with pharmacy costs increasing by 9.7% and outpatient facility care costs rising 8.5%. Healthcare costs for a hypothetical family of four rose to $35,119.
    • “Pharmaceutical costs have been a leading driver of healthcare spending in recent years,” says Milliman Principal and Consulting Actuary Dave Liner. “This year, outpatient facility services and pharmacy costs together accounted for nearly 70% of the total cost increase. Much of the outpatient growth is linked to high-cost drugs administered in outpatient settings.”
    • In recognition of the MMI’s 20th anniversary, this edition includes a look back at how healthcare costs have evolved in the last 20 years. “Since we began publishing the MMI 20 years ago, healthcare costs for American families have nearly tripled,” says Milliman Principal and Consulting Actuary Deana Bell. “Annual growth has averaged 6.1%, far outpacing any other household expense. No other cost category has risen as steeply or as consistently over the past two decades. Outpatient facility care saw the largest increase of any category, rising 286% since 2005, reflecting the growing complexity of procedures now handled outside of inpatient settings.”
    • Read this year’s MMI.
  • An essayist writing in the Wall Street Journal, opines “America’s hospital-bed shortage is about to become a crisis. As new construction declines and occupancy rates soar, experts warn that hospitals may soon cease to function properly because of overcrowding.”
  • Modern Healthcare reports,
    • “Health systems, accountable care organizations and others are bringing extra staff and tracking technology into post-acute care to reduce hospital readmissions.
    • “Health systems, such as OSF Healthcare, and accountable care organizations, such as Provider Partners Connect Care are using remote patient monitoring equipment, electronic medical records software and additional staff to ensure patients don’t have a set-back that will send them back to the hospital. Readmissions add costs that ripple through the healthcare system and the Centers for Medicare and Medicaid Services penalizes hospitals and nursing homes for higher-than-predicted readmissions within 30 days of a hospital discharge.”
  • and
    • “UnityPoint Health, based in West Des Moines, Iowa, and MercyOne Siouxland Medical Center in Sioux City, Iowa, have signed a letter of intent for UnityPoint to acquire the medical center. The proposed agreement includes the hospital, its associated facilities, physician practices and home care services. The acquisition is expected to be finalized this summer, pending customary closing conditions.”
  • and
    • MDaudit, a cloud-based continuous risk monitoring platform that helps healthcare organizations reduce billing vulnerabilities and increase revenue, has entered into a definitive merger agreement to acquire Streamline Health Solutions, a provider of tools that help healthcare providers improve financial performance. The all-cash transaction is valued at approximately $37.4 million, including debt. The deal is expected to close in the third quarter.
  • Per Fierce Healthcare,
    • Women’s healthcare company Wisp has launched a diagnostics arm to offer low-cost testing at home for sexual and reproductive health, the company announced May 28. 
    • Wisp is an online platform that prescribes medication for a range of women’s health needs such as oral contraception, yeast infections, fertility, emergency contraception and some medication abortion. Women can pick up their prescriptions at the pharmacy on the same day as their request, following approval by a provider. Wisp also ships medications in discreet packaging. 
    • Wisp will now offer at-home tests for common sexually transmitted infections and free telehealth consultations for positive results, according to a release by the company. Patients will send completed urine tests or swabs to a partnered CLIA/CAP accredited laboratory and receive results in three to five business days. 
    • “The new model expands on Wisp’s direct-to-consumer telehealth platform and eliminates the need for patients to visit an in-person clinic to complete diagnostic testing. Patients can collect samples at home with tests sent in discreet packaging to maintain privacy in their healthcare and receive services entirely from home.”
  • and
    • “Talkspace inked a partnership with Amazon Pharmacy to streamline psychiatric medication fulfillment and home delivery for its members.
    • “It marks the first time a virtual behavioral health solution has integrated with Amazon Pharmacy, the companies said.
    • “Psychiatric patients of Talkspace can now have their medications fulfilled through Amazon Pharmacy and delivered to their homes for seamless medication management. Talkspace and Amazon Pharmacy tout the partnership will improve medication adherence for Talkspace members.” 
  • Per Healthcare Dive,
    • Best Buy reported $109 million in charges primarily linked to restructuring at the electronics retailer’s health unit in its first quarter, the company said in earnings released Thursday. 
    • The company began restructuring its health business after it recorded a non-cash goodwill impairment charge of $475 million in its fourth quarter ended Feb. 1, linked to a downward revision in the long-term financial projections for its health segment. 
    • The retailer partners with healthcare organizations to provide in-home health services, but the business has taken “longer to develop than we initially thought,” as providers grapple with financial challenges and the future of the federal government’s hospital at home waiver seems uncertain, Best Buy CEO Corie Barry said during a call with investors Thursday.