Monday report

U.S. Healthcare

Monday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Medicare drug plan premiums are expected to rise significantly next year due to rising costs and regulatory changes.
    • “A subsidy program that shielded seniors from rising monthly bills will be cut by about 40% in 2026.
    • “The premium increase will affect millions of seniors and may push more enrollees into Medicare Advantage plans.”
  • KFF tells us,
    • “Two new KFF analyses examine the latest data about Medicare Advantage, including trends in enrollment, premiums, out-of-pocket limits, supplemental benefits and prior authorization.
    • “The first analysis, focusing on enrollment trends, finds that 54% of eligible Medicare beneficiaries are enrolled in Medicare Advantage in 2025, though increases in enrollment slowed this year. One in five Medicare Advantage enrollees is in a special needs plan (SNP), reflecting a steady increase in recent years. And Medicare Advantage enrollment remains highly concentrated among a handful of insurance companies. 
    • “The second analysis finds that more than three quarters (76%) of enrollees in individual Medicare Advantage plans with prescription drug coverage pay no premium other than the Medicare Part B premium. The share of enrollees in plans offering a rebate against the Part B premium rose sharply from 12% in 2024 to 32% in 2025, but among these enrollees, about half are in plans that offer rebates of less than $10 a month while fewer (36%) are in plans that offer rebates of $50 or more per month. Prior authorization is most often required for expensive services such as skilled nursing facility stays (99%), Part B drugs (98%), inpatient hospital stays (acute: 96%; psychiatric: 93%) and outpatient psychiatric services (80%).” 
  • STAT News reports,
    • “No decision has been made on the future of an advisory panel [the U.S. Preventive Services Task Force] that decides which preventive care offerings, like cancer screenings, must be covered by insurers, a federal health department spokesperson said, after a [Wall Street Journal] report that health secretary Robert F. Kennedy Jr. is planning to oust all members. 
    • “But the report has alarmed the American Medical Association, which is calling on Kennedy to keep the panel’s members in place.” 
  • Modern Healthcare informs us,
    • “The Centers for Medicare and Medicaid Services wants to take another crack at creating a national provider directory in an effort to replace insurance company lists that are often riddled with errors.
    • “Health and Human Services Secretary Robert F. Kennedy Jr. and CMS Administrator Dr. Mehmet Oz touted the idea at a meeting with health information technology executives in June. In a later post on the social media platform X, CMS described its goal as a “dynamic, interoperable directory that connects the data CMS has with what the industry knows, so we all work from the same map.” * * *
    • “The insurance industry would support a national provider directory “grounded in a robust public-private partnership,” the trade group AHIP said in a statement. At the AHIP 2025 conference last month, executives from Centene, Cigna and Aetna parent company CVS Health said their companies have met with CMS to discuss the concept.”
  • and
    • “Top Trump administration health officials are expected to bring tech companies to the White House this week to roll out a plan to encourage more seamless sharing of healthcare data, according to people familiar with the matter.
    • “Health and Human Services Secretary Robert F. Kennedy Jr. and Centers for Medicare and Medicaid Services Administrator Mehmet Oz are expected to host executives at an event on Wednesday, said the people, who did not provide names of the attendees and asked not to be named because the details haven’t been made public.
    • “The plan was developed in coordination with the White House, building on a May effort by CMS to get public input on addressing barriers to sharing patient data.”
  • The American Hospital Association lets us know,
    • “The Substance Abuse and Mental Health Services Administration July 28 released its latest national survey on drug use and mental health. Among the findings, the percentage of adolescents aged 12 to 17 who had serious thoughts of suicide declined from 12.9% in 2021 to 10.1% in 2024. It also found a decline in adolescents who experienced a major depressive episode, dropping from 20.8% in 2021 to 15.4% in 2024. The survey also found that among the 61.5 million adults aged 18 or older in 2024 with any mental illness, 52.1% (32 million) received any mental health treatment in the past year. Among 14.6 million adults with serious mental illness in the past year, 70.8% (10.3 million) received mental health treatment. Due to changes to the survey questions and approach, not all estimates in the 2024 survey are comparable with 2023 and 2022 estimates, SAMHSA notes.” 
  • An HHS news release adds,
    • “The U.S. Department of Health and Human Services (HHS) has announced a $100M pilot funding opportunity to prevent, test for, treat, and cure Hepatitis C (HCV) in individuals with substance use disorder (SUD) and/or serious mental illness (SMI). This program is designed to support communities severely affected by homelessness and to gain insights on effective ways to identify patients, complete treatment, cure infections, and reduce reinfection by Hepatitis C (a liver disease caused by the Hepatitis C virus).
    • “HHS is delivering on our promise to the American people for a healthier, brighter future,” said HHS Secretary Robert F. Kennedy, Jr. “Through this pilot program, we are launching a comprehensive, integrated care model that not only cures HCV but also tackles critical risk factors like substance use, mental health challenges, and homelessness head-on.”
  • Beckers Hospital Review highlights five things to know about the foreign trade deals that the Trump administration has recently struck.

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has given Sarepta Therapeutics a green light to resume shipping its gene therapy Elevidys to some patients with Duchenne muscular dystrophy, a little over one week after demanding the company halt sales over safety concerns. 
    • “In a statement Monday evening, Sarepta said it would begin shipments to treatment sites “imminently.” The resumption applies only to Duchenne patients who can still walk, which typically describes individuals who are younger and whose disease hasn’t advanced as far.”
  • and
    • “The Food and Drug Administration has delayed its review of a Bayer therapy for hot flashes related to menopause, telling the drugmaker it needs additional to review the company’s application.
    • “In a Friday statement, Bayer said the FDA did not raise any concerns around “general approvability” of the drug, called elinzanetant. Still, the agency extended its decision deadline by three months.”
  • Per MedTech Dive,
    • “Johnson & Johnson’s Ethicon unit has corrected disposable surgical stapler cartridges over a fault related to one death and one injury, the Food and Drug Administration said Friday.
    • “The company wrote to customers in April after learning that devices may activate but not cut or staple tissue. Additional steps are needed to open and remove locked devices from tissue. 
    • “Ethicon designed the stapler to prevent lockout events from harming patients. Still, the FDA said the lockout problem could cause life-threatening hemorrhage, surgical delay and death.”

From the public health and medical research front,

  • The New York Times reports,
    • “A combination of healthy activities including exercise, nutritious diet, computer brain games and socializing can improve cognitive performance in people at risk for dementia, according to a large new study.
    • “The study, conducted in five locations across the United States over two years, is the biggest randomized trial to examine whether healthy behaviors protect brain health.
    • “It confirms that paying attention to things like physical activity and vascular risk factors and diet are all really important ways to maintain brain health,” said Dr. Kristine Yaffe, an expert in cognitive aging at the University of California, San Francisco, who was not involved in the study.
    • “The results were presented on Monday at the Alzheimer’s Association International Conference in Toronto and published in the journal JAMA.”
  • The Washington Post adds,
    • “Any amount of walking is good for your health but picking up the pace has significant benefits — and it’s never too late for someone to train to walk faster.
    • “In an analysis published in PLOS One earlier this month, researchers found that frail older adults who deliberately walked faster saw a meaningful improvement in the distance they could travel when instructed to walk for six minutes straight. (Frailty is an age-related syndrome that affects 5 to 17 percent of older adults and is characterized by fatigue, a loss of strength and unexplained weight loss.)
    • “The results show that regardless of your age, the intensity of your workout can lead to greater improvements in physical function, said Daniel Rubin, the lead author of the analysis and an associate professor of anesthesia and critical care at the University of Chicago.”
  • Per the National Academy of Medicine,
    • “With more than half a million people globally living beyond the age of 100, it is time to rethink how health professionals and educators view older adults and the aging process. “Redefining aging” begins with transforming the mindset of current and future health professionals through targeted education. This involves encouraging them to reconsider how they address the unique needs of older adults and identifying those who can drive this change. Educators, health professionals, administrators, and policymakers must collaborate to reshape systems and attitudes. Together, they can build a well‑trained workforce that is not only prepared but motivated to address the complexities of aging that may include chronic disease and functional decline but also opportunities for growth and innovation. The barriers to achieving a change in mindset and solutions for overcoming challenges prompt a call to action. This paper is an entreaty by a group of interprofessional educators passionate about ensuring all health professionals are trained to meet the complex needs of older adults.”
  • MedPage Today tells us,
    • “Chronic obstructive pulmonary disease (COPD) affects at least 4.5% of those 18-49 years old, according to an analysis of U.S. cohorts * * * as reported in NEJM Evidence.”
    • “The early COPD group was more likely to be hospitalized or die from chronic respiratory disease, to develop heart failure, and to die before 75 years of age from any cause.
    • “Having a definition for early COPD might allow for studies to find ways to treat the disease and reduce its impact.”
  • The AHA News informs us,
    • “Five pediatric flu deaths were reported to the Centers for Disease Control and Prevention last week, pushing the total to 266 for the 2024-2025 flu season, according to the latest data. The total is the highest reported in any non-pandemic flu season since the agency began reporting it in 2004. The CDC said 90% of reported pediatric deaths this flu season have happened to children who were not fully vaccinated against the flu.”
  • The American Medical Association lets us know what doctors wish their patients knew about the impact of caffeine.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Bristol Myers Squibb BMY and Bain Capital are forming a new biopharmaceutical company focused on therapies for autoimmune diseases.
    • The new company will be created with $300 million in financing led by Bain Capital, including funds from the Canada Pension Plan Investment Board.
    • The company will begin with five potential treatments for autoimmune diseases in-licensed from Bristol Myers Squibb, which will retain 20% equity in the new company. Bristol Myers Squibb will also be entitled to royalties and milestones from the potential treatments.
    • Biotech executive Daniel Lynch, currently chairman of the board at Xilio Therapeutics XLO, will lead the new company as chief executive.
  • Per BioPharma Dive,
    • “GSK is turning to a China-based biotechnology company in search of its next blockbuster medicine, announcing Monday a broad drug making alliance with Hengrui Pharma that could be worth billions of dollars.
    • “GSK will pay Hengrui $500 million upfront to start the alliance. In return, it will receive rights outside of the greater China region and Taiwan to an experimental drug for chronic obstructive pulmonary disease as well as the potential to develop up to 11 other therapies for respiratory illnesses, immune disorders or cancer. If a variety of milestones are met, the deal could be worth up to $12 billion, plus royalties, GSK said.”
  • Beckers Payer Issues offers us six prior authorization updates that Beckers has reported since June 23.
  • Per an NIH news release,
    • “Researchers at the National Institutes of Health (NIH) have developed an artificial intelligence (AI) agent powered by a large language model (LLM) that creates more accurate and informative descriptions of biological processes and their functions in gene set analysis than current systems.
    • “The system, called GeneAgent, cross-checks its own initial predictions—also known as claims— for accuracy against information from established, expert-curated databases and returns a verification report detailing its successes and failures. The AI agent can help researchers interpret high-throughput molecular data and identify relevant biological pathways or functional modules, which can lead to a better understanding of how different diseases and conditions affect groups of genes individually and together.”

Weekend Update

David Ermer–Congress, Generative AI, Medical / Rx research, U.S. Healthcare–

From Washington, DC

  • Roll Call discusses likely Senate activities this week.
  • Congress in the July 4, 2025, budget reconciliation act (§ 90101, at 291) did enact a law requiring OPM to place more internal controls over family member eligibility.
    • – No later than 12/31/25, OPM must develop a process by which any [ineligible] individual enrolled in, or covered under, a [FEHB or PSHB] shall be disenrolled or removed from enrollment in, or coverage under, that plan.
  • This requirement should include implementation of the HIPAA 820 standard enrollment roster transaction. 
    • – No later than July 3, 2026, OPM must issue regulations and implement a process to verify – (1) the veracity of any qualifying life event through which an enrollee seeks to add a member of family to his/her coverage; and (2) that, when an enrollee in the Program seeks to add a member of family to his/her coverage, including during any open season, the individual so added is a qualifying member of family with respect to the enrollee.
  • It would be sensible for OPM to implement a program similar to TRICARE’s DEERS program which places the reporting burden on the TRICARE enrollee. 
  • HIPAA Suite explains,
    • “The HIPAA 820 transaction set [which has been around since 2008] handles the [electronic] communication between a sponsor that is an entity that pays for someone’s health care, and another entity that manages health care benefits, such as an insurance company.
    • “For example, a large employer that has a contract with an insurance company or a government agency that handles social and health benefits will use the 820 transaction to manage premium payments. This information can either be very detailed and contain demographic information on each individual that is covered or just contain a summary of the payment for all members.
  • The HIPAA standard transaction law requires health plans to be able to process the HIPAA 820. What’s more nearly half of FEHB and PSHB enrollees have self only coverage.

From the public health and medical reseach front,

  • MedPage Today reports,
    • “For years, we’ve told our patients that human papillomavirus (HPV) vaccination works best when administered before sexual debut — and rightfully so. But what happens when a woman has already developed high-grade cervical dysplasia and undergoes surgical treatment?
    • Our recent study, published in The Lancet Regional Health – Europe, explored that very question. And the results were striking: women who received the HPV vaccine after surgical excision (conization) experienced a 74% reduction in recurrent high-grade cervical lesions (CIN2+), with the most dramatic benefit seen within the first 6 months after surgery.
  • and
    • “Cases of “Ozempic mouth” and “Ozempic teeth” have recently been described in the news, with most of the problems — inflammation affecting the gums, tooth decay, and even bad breath — linked to a dry mouth.
    • “All of the GLP-1 agonists that we use now cause changes in how everything is secreted in your GI tract,” Ann Marie Defnet, MD, who specializes in obesity medicine and bariatric surgery at Northwell Health’s North Shore University Hospital and Long Island Jewish Medical Center in New York City, told MedPage Today. And this “definitely has an impact on saliva.”
    • “People taking GLP-1 drugs also tend to be a bit dehydrated because they are often not hungry or thirsty, she noted.
    • “I haven’t seen too many horrible cases of periodontal disease, gingivitis, or anything like that, nor have I had any patients really complaining about dry mouth,” she noted. “But definitely I have patients all the time that [say], ‘Oh yeah, I can tell I’m dehydrated.'”
    • “Defnet said she believes some of the serious oral health issues that have been reported are likely representative of “more of a later stage issue with patients who maybe just aren’t staying hydrated in general.”
    • “One of the big things I always counsel my patients on is they just have to remember to continue to drink water, even if they’re not thirsty, even if they’re not hungry,” Defnet said. “That seems to help with all of these symptoms.”
  • The New York Times discusses “Coronary artery calcium testing [which] can reveal plaque in arteries, offering a more precise estimate of a patient’s risk [of having a heart attack]. Yet the test remains underused.”
    • “A brief and painless CT scan, it would show whether the fatty deposits called plaque were developing in the arteries leading to her heart.
    • “When plaque ruptures, it can cause clots that block blood flow and trigger heart attacks. The scan would help determine whether Ms. Hollander would benefit from taking a statin, which could reduce plaque and prevent more from forming.
    • “The test is used by more people every year,” said Dr. Michael Blaha, co-director of the preventive cardiology program at Johns Hopkins University. Calcium scans quadrupled between 2006 and 2017, his research team reported, and Google searches for related terms have risen even more sharply.
    • “Yet “it’s still being underused compared to its value,” he said.
    • “One reason is that although the test is comparatively inexpensive — sometimes up to $300, but often $100 or less — patients must pay for it out of pocket. Medicare rarely covers it, though some doctors argue that it should.”

From the U.S. healthcare business front,

  • Radiology Business lets us know,
    • “Physicians are increasingly exiting Medicare, according to new research published in JAMA Health Forum. 
    • “Radiology and other specialties have expressed concern in recent years that inadequate payment rates could push practices to close or stop accepting the federal program for seniors. Since 2001, Medicare reimbursements to physicians have fallen 33%, when adjusting for inflation, according to the American Medical Association. 
    • “Researchers recently sought to test this theory, analyzing 100% of fee-for-service Medicare Part B claims logged between 2010 to 2024. They found the share of physicians exiting Medicare increased “significantly” from 1.8% to 3.6% by the end of the study period. 
    • “The findings may reflect multiple factors, including the greater burden of new communication methods (e.g., portal messages) and demands for clinical documentation,” Hannah T. Neprash, PhD, and Michael E. Chernew, PhD, healthcare policy experts with the University of Minnesota and Harvard Medical School, respectively, wrote July 18. “More rapid growth in exit[s] among small practices likely contributes to consolidated physician markets, given that new physicians increasingly work for large practices.”
    • “Researchers excluded docs who on average billed for fewer than 100 Medicare claims annually. They defined an exit as the absence of any claims in the payment program for 12 consecutive months. Altogether, the study sample included over 791,000 physicians at an average age of nearly 45. Physician Medicare exits displayed a gradual increase from 2010-2013 before stabilizing between 2014-2016. They saw another gradual increase from 2017-2019 and then spiked amid the COVID-19 pandemic in 2020-2021 before returning to regular levels by 2023.” 
  • The boilerplate in an FEHB or PSHB brochure (meaning its OPM policy) reads,
    • If you are enrolled in Medicare Part B, a physician may ask you to sign a private contract agreeing that you can be billed directly for services ordinarily covered by Original Medicare. Should you sign an agreement, Medicare will not pay any portion of the charges, and we will not increase our payment. We will still limit our payment to the amount we would have paid after Original Medicare’s payment. You may be responsible for paying the difference between the billed amount and the amount we paid.
  • MedCity News informs us that “Sentara Health has rolled out Regard’s AI-powered chart review and discharge summary tool across all 12 of its hospitals [located in Virginia and North Carolina]. The tool has delivered consistent benefits when it comes to patient safety and documentation accuracy, said Joseph Evans, Sentara’s chief health information officer.

Friday report

David Ermer–CDC, Congress, COVID-19, No Surprises Act, Obesity, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Here is a link to OPM Director Scott Kupor’s second weekly blog post which is titled “Rightsizing with a purpose.”
  • The Wall Street Journal reports,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. is planning to remove all the members of an advisory panel that determines what cancer screenings and other preventive health measures insurers must cover, people familiar with the matter said.
    • “Kennedy plans to dismiss all 16 panel members of the U.S. Preventive Services Task Force because he views them as too “woke,” the people said.
    • “The White House has made a priority of targeting initiatives that promote diversity equity and inclusion, or DEI, in everything from artificial intelligence to health research grants.
    • “The task force has advised the federal government on preventive health matters since 1984. The Affordable Care Act in 2010 gave it the power to determine which screenings, counseling and preventive medications most insurers are required to cover at no cost to patients. The group, made up of volunteers with medical expertise who are vetted for conflicts of interest, combs through scientific evidence to determine which interventions are proven to work.
    • “The Supreme Court decided a case in June that centered on a task-force recommendation to cover HIV-prevention drugs. The employer plaintiffs in the case had argued that requiring them to cover such drugs for employees violated their religious rights and that the task-force members weren’t properly appointed. The high court ruled that the task- force appointments were constitutional, while highlighting that the Health and Human Services Secretary has the authority to remove the members of the panel at will.”
  • Per a Senate news release,
    • Today, U.S. Senators Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, Maggie Hassan (D-NH), and Roger Marshall, M.D. (R-KS) highlighted the importance of fully implementing the No Surprises Act, which protects patients from surprise medical bills and ensures they know the cost of care before receiving it. This bipartisan legislation was signed into law by President Trump in 2020 as part of his efforts to improve price transparency and lower health costs for American patients.
    • “Nearly five years ago, President Trump signed the No Surprises Act (P.L. 116-260) into law. This historic, bipartisan legislation protects patients from surprise medical bills and ensures that they know the cost of care before receiving it,” wrote the senators. “Ensuring that patients have transparent, personalized cost estimates for their health care is a bipartisan priority. Full implementation of both the good faith estimate and advanced explanation of benefits are critical to providing patients with the entirety of protections enacted under the No Surprises Act…We commend President Trump’s commitment to price transparency and stand ready to assist to ensure a successful and complete implementation of the No Surprises Act.”
    • Since the bipartisan legislation led by Senators Cassidy and Hassan was signed into law by President Trump in 2020, the No Surprises Act has protected American patients from more than 25 million surprise medical bills. This would not be possible without the work of the Departments of Health and Human Services, Labor, and the Treasury.
    • To build on this success, the senators are requesting rules to implement provisions in the law to give covered patients clear cost estimates before their scheduled medical care. To date, the good-faith estimate has been implemented for uninsured and self-pay patients. Additional rulemaking is needed to implement the good-faith estimate and the advanced explanation of benefits for covered patients. For a patient with insurance, providers and facilities are required to provide the good-faith estimate to the individual’s health plan or issuer of coverage, which in turn, must use the estimate to give the patient an advanced explanation of benefits outlining what the plan will cover and what the individual will owe out of pocket.
    • Read the letter here 
  • If Congress wants to improve the No Surprises Act, it should refine the dispute resolution process.
  • Healthcare Dive tells us,
    • “More than 200 telehealth and provider organizations are asking the Trump administration to hammer out regulation governing telehealth prescriptions of controlled substances before pandemic-era flexibilities expire at the end of the year. 
    • “In a letter sent to Terry Cole, the newly confirmed administrator of the Drug Enforcement Administration, the groups urged the administration to ensure a plan is in place by fall so patients can continue to receive remote prescriptions of controlled substances.
    • “The Biden administration proposed a framework for telehealth prescriptions just before President Joe Biden left office in January, but some industry groups have panned the proposed rule as too onerous for providers.”

From the public health and medical research front,

  • The U.S. Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many Southeast, Southern, and West Coast states. 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 young children 0-4 years old. COVID-19 model-based epidemic trends (Rt) and wastewater activity levels indicate that COVID-19 activity is increasing in many Southeast, Southern, and West Coast states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.”
  • The University of Minnesota’s CIDRAP adds,
    • “Emergency department visits rose 4.8% compared to the week before, mainly in children up to 4 years old. Test positivity rose slightly and is now at 5.3% nationally, with levels highest in the Southwest, followed by the South.
    • Wastewater SARS-CoV-2 detections remained at the low level and are highest in the West, with other regional hot spots, including Louisiana with very high activity and Florida with high activity.
    • “The CDC has not updated its variant proportion estimates since the middle of June owing to low numbers of sequences reported when the NB.1.8.1 subvariant was the most common. Variant proportions predicted from testing in international travelers during the same period suggested the XFG variant—one of many JN .1 offshoots— was most common. Both are considered variants under monitoring by the World Health Organization, which in late June said XFG seems to have a moderate growth advantage and a low risk of immune escape, though it added that confidence in its assessments were low because of recent expansion and low sequencing levels.”
  • The CDC also reports,
    • “Tetrahydrocannabinol (THC), a psychoactive substance found in Cannabis sativa plants, including varieties such as hemp, is increasingly being used in consumer products.
    • “During October 22–24, 2024, at least 85 persons, ranging from age 1–91 years, ate food from a restaurant in Wisconsin and experienced symptoms consistent with THC intoxication. The restaurant was in a building with a cooperative (i.e., shared) kitchen used by a state-licensed vendor who produced edible THC products. The restaurant mistakenly used THC-infused oil from the cooperative kitchen to prepare dough.
    • “Clinicians and public health practitioners should be alert to the possibility of mass THC intoxication events via food.
  • Doug Corley, MD, PhD, of The Permanente Medical Group, tells us why rising colon cancer rates—up 2% yearly in younger patients—demand earlier screening.
    • “Younger people are at increased risk compared to what they were,” said Doug Corley, MD, PhD, chief research officer for The Permanente Medical Group. Colorectal cancer “is a substantial problem, and it causes a lot of mortality … and morbidity.”
    • “The Permanente Medical Group is a part of the AMA Health System Member Program, which provides enterprise solutions to equip leadership, physicians and care teams with resources to help drive the future of medicine.
    • “Dr. Corley discussed the growing concerns about colon cancer in younger people, as well as how The Permanente Medical Group is helping these populations in a recent episode of “AMA Update.”
  • The American Hospital News lets us know,
    • “A report from AARP and the National Alliance for Caregiving released today found nearly 1 in 4 U.S. adults (63 million) are caring for an adult or child with a complex medical condition or disability. Over half of the caretakers are managing complex medical and nursing tasks like injections, wound care or medication management, though only 20% have training to do so.”
  • Per Medscape,
    • “Urgent care visits frequently result in inappropriate prescribing, with 12.4% leading to antibiotic fills, 9.1% to glucocorticoid fills, and 1.3% to opioid fills. Analysis of over 22.4 million urgent care visits revealed concerning patterns, including 40.8% of acute bronchitis visits resulting in inappropriate glucocorticoid prescriptions.” * * *
    • “Inappropriate prescribing in urgent care is influenced by clinician knowledge, patient demands, and lack of decision support. Antibiotic, glucocorticoid, and opioid stewardship programs are needed to reduce inappropriate urgent care prescribing and support long-term glucocorticoid and opioid deprescribing efforts,” wrote the authors of the study.”
    • “The study was led by Shirley Cohen-Mekelburg, MD, MS, Division of Gastroenterology and Hepatology and Institute for Healthcare Policy and Innovation, University of Michigan in Ann Arbor, Michigan. It was published online on July 21 in Annals of Internal Medicine.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Centene swung to a loss in the second quarter and offered a drastically reduced projection for full-year earnings, delivering a result even worse than Wall Street feared amid growing signs of a financial meltdown across the health-insurance industry.
    • “The managed-care company, which focuses on Medicaid, Affordable Care Act plans and Medicare, withdrew its earnings guidance for 2025 earlier this month, citing rising costs in Medicaid and problems in the ACA business. 
    • “Centene’s latest woes come after smaller competitor Molina Healthcare reduced its 2025 earnings projection for the second time in a month, and larger Elevance Health reported cost pressures as well. Industry bellwether UnitedHealth Group is set to report earnings next Tuesday, after earlier this year withdrawing its own guidance and replacing its chief executive. 
    • “The entire industry is contending with rising costs as well as a shifting membership and regulatory landscape across various lines of business that appear to have weakened insurers’ ability to predict the risks of the populations they enroll—a fundamental function.
    • Centene said in a conference call with analysts on Friday that it expects results to improve next year as it seeks higher payments and tightens its operations.” 
  • STAT News adds,
    • “Hospitals’ finances are strongly influenced by two factors: the prices they negotiate with insurers and how many patients they treat in their facilities. Right now, the latter does not appear to be the main driver of their strong profits. Inpatient and outpatient surgeries, which tend to be hospitals’ profit centers, were down slightly at both companies. Admissions barely budged. Another hospital chain, Community Health Systems, reported similarly underwhelming patient numbers this week. 
    • “It’s a different story among insurers, who say they’re being forced to shell out more money than usual for their members’ medical costs, particularly those who rely on Medicaid and Affordable Care Act plans. Elevance’s finance chief described what’s happening as a “market-wide morbidity shift,” meaning patients are sicker than the companies had expected when they priced their policies.
    • “One number may help explain why hospitals are faring well as insurers struggle: the amount of money hospitals make on each patient. In Tenet’s outpatient surgery business, revenue per case was up 8.3% year-over-year on a same-facility basis. In its hospital segment, that metric grew 5.2%. Tenet chalked that up to charging insurers higher prices — framed as patients having better-paying insurance — and its focus on offering higher-acuity services like cardiac care and orthopedics. At HCA, revenue per admission grew 4% year-over-year on a same-facility basis.”
    • “And consider which services are at issue for insurers. On the Medicaid front, Elevance said its members are using more home health, transportation, adult day care, and services to help them with daily activities like bathing and dressing. They’re also getting more behavioral health services and inpatient surgeries. As for people on ACA plans, the increase in care is concentrated among emergency room visits, behavioral health services, and high-cost drugs. 
    • “But on Friday, HCA said it’s seeing less demand for services among Medicaid patients.”
  • Here’s a link to a Beckers Hospital Review story about HCA’s second quarter earnings announcement.
    • “Nashville, Tenn.-based HCA Healthcare has reported “16 consecutive quarters of volume growth,” highlighting the strength of its diversified network of markets and services, CEO Sam Hazen said July 25 during the company’s second-quarter earnings call.
    • “The for-profit health system reported a 1.7% year-over-year increase in equivalent admissions for the second quarter and a 2.3% rise year-to-date. YTD managed care equivalent admissions — including the exchanges — increased 4%, in line with HCA’s expectations, according to CFO Mike Marks. Medicare grew 3%, slightly below the company’s expectations.
  • Per Beckers Payer Issues,
    • “With GLP-1 medication costs being a top concern for employers heading into 2026, UnitedHealthcare is addressing the challenge through its Total Weight Support program, aimed at improving weight loss outcomes for employees while managing the costs of medication adherence. 
    • “In our conversations and consultations with employers, they are all looking for solutions for their employees who are dealing with obesity and metabolic conditions that bring better value,” Rhonda Randall, DO, chief medical officer for UnitedHealthcare’s commercial business, told Becker’s. “Total Weight Support was put into the marketplace as a comprehensive solution for employers who are looking for that full-person approach to care for their beneficiaries and employees dealing with obesity.”
  • Mercer consulting offers detailed compliance consideration for GLP-1 drug coverage.

Thursday report

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, Patient safety, U.S. Healthcare–

From Washington, DC,

  • It’s worth noting that while the House of Representative has gone out of town for the August recess, the Senate will remain in session through next week.
  • The Wall Street Journal reports,
    • “Hospitals would be required to disclose how they make key decisions regarding extremely premature infants in a bill set to be introduced Thursday by Sen. Tom Cotton (R., Ark.).
    • “The legislation is in part prompted by a Wall Street Journal investigation last year that found mothers had been told no lifesaving measures were possible for their extremely premature infants, even though other hospitals nearby offered care for infants born at similar gestational ages.
    • “The Neonatal Care Transparency Act of 2025 would require hospitals to disclose publicly whether there is a minimal gestational age at which they offer active care for infants, rather than comfort measures before their death. While many hospitals require lifesaving measures to be given at 25 weeks’ gestational age or above, decisions on whether to attempt to save younger premature infants can vary by hospital or even doctor.”
  • Per Senate news releases,
    • “On Thursday, July 31, the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing on how to lower health costs and make health care more affordable for American patients.
      • “Title: Making Health Care Affordable: Solutions to Lower Costs and Empower Patients
      • “Date: Thursday, July 31, 2025
      • “Time: 10:00 AM ET/ 9:00 AM CT
      • “Location: 430 Dirksen Senate Office Building
      • “Click here to watch live”
  • and
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will hold a nomination hearing on Thursday, July 31, 2025, at 10:00 AM ET to consider Bryan Switzer to be a Deputy United States Trade Representative (USTR), Gustav Chiarello III to be an Assistant Secretary of Health and Human Services (HHS), Michael Stuart to be General Counsel of HHS and Derek Theurer to be a Deputy Under Secretary of the Treasury.
      • “Title: Hearing to consider nominees for USTR, HHS and Treasury
      • “Witnesses: Bryan Switzer; Gustav Chiarello; Michael Stuart; Derek Theurer
      • “Date: Thursday, July 31, 2025
      • “Time: 10:00 AM ET
      • “Location: 215 Dirksen Senate Office Building
      • “Witness testimony, opening statements and a live video of the hearing will be available on www.finance.senate.gov.”
  • The Society for Human Resource Management tells us,
    • “The annual employee contribution limit for dependent care flexible spending accounts (FSAs) is increasing by 50% beginning next year, a change employers will want to communicate to employees as open enrollment season gears up. 
    • “The massive tax law that President Donald Trump signed July 4, known as the One Big Beautiful Bill Act, raises the limit for the pretax benefit account used to pay for eligible dependent care services to $7,500 for single individuals and married couples filing jointly, up from $5,000, and $3,750 for married couples filing separately, up from $2,500. The increase is effective beginning Jan. 1, 2026.
    • “Industry experts have been pushing for a higher contribution limit for years, calling the new increase long overdue. Although other limits, such as for health savings accounts and medical FSAs, are indexed for inflation and usually increase nominally each year, that’s not the case for dependent care FSAs. The current limits have been in place since 1986, except for a temporary increase during the pandemic.
    • “The increase is a “game changer for both working parents and businesses,” said Sara Redington, co-founder of The Best Place for Working Parents (BP4WP), a Fort Worth, Texas-based organization that recognizes employers supporting working parents.”
  • Tammy Flanagan, writing in Govexec, discusses “Why federal retirements are spiking this year. A sharp rise in retirement claims may be tied to fear instead of planning. If you’re eyeing the exit, make sure you’re not rushing into something you’ll regret.”
  • Per STAT News,
    • “Everyone agrees that diet is important to good health. And yet fewer than a third of medical students receive the recommended minimum of 25 hours of nutrition education, and more than half report receiving no formal education on the topic at all. 
    • “That’s why health secretary Robert F. Kennedy Jr. may be pushing on an open door with his plans to require medical schools to include nutrition education in their curricula or else lose federal funding. 
    • “One of the things we’re gonna do at NIH is to really give a carrot and stick to medical schools across the country saying you gotta put in your first-year curriculum a really good, robust nutrition course,” he said in a video posted to his Instagram account earlier this month. 
    • “Medical experts who spoke with STAT noted that there is no standardized curriculum for nutrition, and that it’s not yet clear what specifics Kennedy may attach to funding or what training medical schools might have to cut back to make room for nutrition courses. But they were on board with Kennedy’s general goal, noting that many nutrition and food policy experts have been calling for this kind of change for years. A 2022 House of Representatives resolution on the need for better nutrition education also won bipartisan support. And some medical schools have already taken steps to strengthen their offerings on the subject.”

From the Food and Drug Administration front,

  • Fierce Pharma points out,
    • “Although Sarepta Therapeutics managed to defuse a brief stalemate with the FDA earlier this week, the U.S. drug regulator is reportedly going to put the company to work in order to affirm the safety of its Duchenne muscular dystrophy (DMD) gene therapy Elevidys.
    • “Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the company over a mounting string of controversies—to the FDA, Endpoints News reported Thursday, citing an unnamed senior FDA official.
    • “It’s unclear what sorts of studies Sarepta would need to run to get Elevidys back in the agency’s good graces, or whether the company might need to conduct a new clinical trial, Endpoints noted. The publication said it was unable to independently verify the internal FDA discussions alluded to by the official.
    • “That said, no one at the FDA thinks the treatment should return to market based on current data, an anonymous FDA official told Bloomberg.”
  • and
    • “Danish dermatology specialist Leo Pharma has scored an FDA approval that makes its JAK inhibitor cream Anzupgo (delgocitinib) the first therapeutic in the U.S. specifically indicated for chronic hand eczema (CHE).
    • “The endorsement covers adults with moderate to severe CHE for whom topical corticosteroids either have been inadequate or are not suitable. In September of last year, Anzpugo became the first topical treatment for the condition approved in Europe.
    • “Dermatologists hailed the approval as a long-awaited treatment option for a condition that is often overlooked despite it affecting 1 in 10 adults in the world. A recent study commissioned by Leo and conducted by Ipsos showed that more than half of nearly 200 dermatologists who were surveyed were frustrated by the lack of progress in the indication.
    • “They said current therapeutics for moderate to severe atopic dermatitis—which are often prescribed to treat CHE—don’t sufficiently translate as treatments for moderate to severe CHE.”
  • The American Hospital Association News lets us know,
    • “The Food and Drug Administration has identified a Class I recall of Edwards Lifesciences OptiSite Arterial Perfusion Cannula devices due to the potential for serious injury or death. Edwards identified incidents in which a 3mm to 4mm section of wire from the wire-reinforcement coil at the cannula tip was found to be exposed. The FDA said that some Femoral Arterial Cannula models are made of the same components as the OptiSite Arterial Perfusion Cannula models. Edwards has called for both products to be removed from wherever they are used or sold.”
  • Modern Healthcare reports,
    • “The Food and Drug Administration has classified Baxter’s recall of its Q-Link 13 mobile lift component as the most serious type, meaning it could lead to critical injuries or death if customers continue to use it.
    • “The Q-Link 13 is used with seven models of the company’s mobile lifts, which are used to move patients with limited mobility from one location to another or help with gait training.
    • “It’s an optional part that can be connected with a quick-release hook for sling bars, which hold the lifting sling. It could be attached incorrectly, possibly causing it to come loose and lead to a patient fall. This could result in serious injury to the patient or a caregiver trying to prevent the fall.
    • “This issue has potentially been associated with three serious injuries and one death, according to Baxter.”

From the judicial front,

  • The Northwest Arkansas Democrat Gazette reports,
    • “A federal judge on Wednesday said he will try to issue a ruling soon on whether a new state law banning pharmacies operated by out-of-state pharmacy benefit managers should be enjoined while the matter is being litigated in court.”
  • Govexec tells us,
    • “The Trump administration revealed to a federal court on Thursday the specific offices at which widespread layoffs were planned as of earlier this year, providing rare insight into the scale of its proposed reductions in force.” * * *
    • “The administration revealed the requests to the U.S. Court for the Northern District of California after Judge Susan Illston ordered their disclosure. Illston previously blocked the administration from moving forward with RIFs at all, but that injunction was overturned by the Supreme Court. The judge is now seeking to verify the legality of RIF plans on an agency-by-agency basis and sought information from 17 agencies the administration had told the Supreme Court were set to begin layoffs when Illston’s injunction took effect. 
    • “The Trump administration said the list in some cases undercounted the number of offices developing RIF plans and in others overcounted and has consistently maintained its plans were moving targets. An appeals court this week blocked another order from Illston requiring the administration to disclose to the court reorganization and RIF plans at every major agency, though those were not yet set to be made public.”  

From the public health and medical research front,

  • The AP reports,
    • “The fertility rate in the U.S. dropped to an all-time low in 2024 with less than 1.6 kids per woman, new federal data released Thursday shows.
    • “The U.S. was once among only a few developed countries with a rate that ensured each generation had enough children to replace itself — about 2.1 kids per woman. But it has been sliding in America for close to two decades as more women are waiting longer to have children or never taking that step at all. 
    • “The new statistic is on par with fertility rates in western European countries, according to World Bank data.
    • “Alarmed by recent drops, the Trump administration has taken steps to increase falling birth rates, like issuing an executive order meant to expand access to and reduce costs of in vitro fertilization and backing the idea of “baby bonuses” that might encourage more couples to have kids.
    • “But there’s no reason to be alarmed, according to Leslie Root, a University of Colorado Boulder researcher focused on fertility and population policy. 
    • “We’re seeing this as part of an ongoing process of fertility delay. We know that the U.S. population is still growing, and we still have a natural increase — more births than deaths,” she said.”
  • The Hill tells us,
    • “A new study suggests diets including eggs, especially the yolk, may help reduce the risk of Alzheimer’s disease.
    • “Published in The Journal of Nutrition, the study followed more than 1,000 U.S. adults and found that those who consumed more than one egg weekly had a 47 percent reduced risk of Alzheimer’s.
    • “Over an average follow-up of 6.7 years, 280 participants, or 27.3 percent, were diagnosed with Alzheimer’s dementia. Researchers found that 39 percent of the “total effect of egg intake” was linked to choline, a nutrient found in egg yolks known to support memory and brain function.
    • “Egg yolks also contain omega-3 fatty acids, which have neuroprotective benefits, further supporting brain health.”
  • The New York Times relates,
    • “Tens of millions of people in the United States struggle with obstructive sleep apnea, a condition that occurs when the throat muscles narrow during sleep, leading to temporary pauses in breathing that can cause people to snore and jolt awake, gasping for air.
    • “Poor sleep can leave people feeling exhausted, irritable and unfocused during the day. And if left untreated, sleep apnea can increase the risk for serious conditions like high blood pressure, Type 2 diabetes, heart attack and stroke.
    • “For decades, the primary treatment for sleep apnea has been continuous positive airway pressure (or CPAP). Before bed, those with the condition put on a face mask that is connected to a CPAP machine, which keeps the airway open by forcing air into it. The machines are effective, but many find them so noisy, cumbersome or uncomfortable that they end up abandoning them.
    • “Now, a more appealing option may be on the way, according to a news release from Apnimed, a pharmaceutical company focused on treating sleep apnea. On Wednesday, the company announced a second round of positive Phase 3 clinical trial results for a first-of-its-kind oral pill that can be taken just before bedtime to help keep a person’s airway open.” * * *
    • “Dr. Phyllis Zee, a sleep doctor and researcher at Northwestern Medicine who was not involved with the trial, said that if approved, the drug could transform the lives of many. That includes not only those who can’t tolerate CPAP machines, but also those who can’t — or prefer not to — use other interventions, such as other types of oral devices or weight loss medications. (Excess weight is a risk factor for sleep apnea.)”
  • Per STAT News,
    • “A Phase 3 study of AstraZeneca’s gefurulimab hit its primary and all secondary endpoints, teeing up talks with regulators about the potential blockbuster treatment for generalized myasthenia gravis, Fierce Biotech writes. AstraZeneca’s high hopes for the drug rest on the belief that the weekly, self-administered medicine can unlock an earlier, broader population than its existing gMG drug Ultomiris. In the study, people on gefurulimab performed significantly better on a gMG scale that assesses the ability to perform daily activities versus those on placebo, achieving the primary endpoint of the study.”
  • The U.S. Preventive Services Task Force released its Final Research Plan for Vision in Children Ages 6 Months to 5 Years: Screening.
  • Aunt Minnie adds,
    • “Changing national lung cancer screening guidelines in 2021 may have contributed to a surge in screening exams, but less lung cancer was detected in newly screened participants, and racial, ethnic, and sexual disparities persisted overall, according to a study published July 21 in the Journal of Thoracic Imaging.
    • “While numerous studies have examined the effects of the U.S. Preventive Services Task Force (USPSTF)’s 2021 lung cancer screening (LCS) guidelines on eligibility, this study focused on participation and lung cancer outcomes over the first 10 years of implementing an LCS program.” * * *
    • “Simply revising the guidelines increases eligibility but does not guarantee participation in LCS for these populations,” Lin and colleagues wrote. “These findings underscore the need for continued emphasis on active outreach and patient education efforts to promote LCS among racial and ethnic minority groups, as well as the further evaluation of how these initiatives impact participation and outcomes.”

From the U.S. healthcare business front,

  • Yahoo Finance lets us know,
    •  “Independence Blue Cross (IBX) is helping to improve recovery outcomes for its Medicare Advantage members after they leave the hospital and reduce costs with its Post-Acute Care Program. The program combines predictive analytics, proactive case management, and a focus on home-based recovery, to ensure members receive the right care at the right time after a stay at the hospital. Since its launch in July 2022, it has helped to improve CAHPS survey scores—a tool used to measure members’ experiences with health care services and strengthen health care in the U.S. It has also delivered $13 million in cost savings and earned the prestigious Blue Cross Blue Shield Association’s (BCBSA) North Star Award for its measurable impact.”
  • Per Beckers Payer Issues,
    • “Priority Health, the insurance arm of Grand Rapids, Mich. based Corewell Health, will become the governing member of Group Health Cooperative of Eau Claire, a Wisconsin-based health plan with more than 61,000 members.
    • “Both organizations expect the transaction to close by the end of 2025, pending regulatory approvals.
    • “The agreement will make Priority Health a four-state health plan with more than 1.3 million members across Michigan, Indiana, Ohio and Wisconsin.”
  • Per the AHA News,
    • “The AHA July 24 announced it is collaborating with health care technology leader Epic to help hospitals adopt tools that support the early detection and treatment of postpartum hemorrhage, a leading cause of maternal mortality. 
    • “The organizations have released a toolkit that includes dynamic risk assessments, clinical decision support and treatment guidance embedded in the electronic health record. With the proper permissions from applicable content providers, users of any EHR should be able to implement a similar set of tools. 
    • “The American Hospital Association and Epic share a deep commitment to improving health outcomes for moms and babies,” said Chris DeRienzo, M.D., AHA chief physician executive and a neonatologist. “This new collaboration amplifies our efforts to drive continuous improvement by sharing evidence-based resources to help reduce this tragic condition. It’s a natural extension of AHA’s Patient Safety Initiative, a collaborative data-driven effort to highlight and learn from patient safety progress at hospitals and health systems around the country.” 
    • “The AHA and Epic will support hospitals in their implementation journey with programming, resources and a space to learn from each other and engage with hospitals already seeing successful outcomes with items that are included in the toolkit.”
  • Healthcare Dive informs us,
    • “Labcorp has agreed to acquire certain ambulatory outreach laboratory assets from Community Health Systems, furthering an expansion push that has seen the testing services provider forge deals with a growing list of local and national health systems.
    • “The $195 million cash agreement with CHS includes patient service centers and in-office phlebotomy locations in 13 states, where Labcorp will assume some facility leases.
    • “Evercore ISI analyst Elizabeth Anderson, in a note to clients Tuesday, called the deal “very much in-line with [Labcorp’s] long-stated hospital management and outreach strategy where it continues to build a strong track record.”

Midweek update

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday report

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

From Washington, DC

  • Roll Call reports,
    • “No more votes are scheduled beyond Wednesday in the House, a change from the previous schedule that reflects a Rules Committee dispute over release of the Jeffrey Epstein case files that will prevent any rules for debate from coming to the floor.
    • “The House is expected to continue to consider legislation under suspension of the rules through Wednesday afternoon but won’t have any more floor votes on Thursday.
    • “That’s a shift from Monday night when Speaker Mike Johnson, R-La., told reporters that the chamber would remain in session through Thursday because of suspension votes and committee meetings.”
  • Because the House of Representatives is scheduled to be on an August recess until September 2, 2025, the House Appropriations Committee will not be taking up the FY 2025 Financial Services and General Government appropriations bill until September.
  • The American Hospital Association News tells us, “The House Ways and Means Subcommittees on Health and Oversight held a joint hearing today to discuss lessons learned, challenges and opportunities to improve the Medicare Advantage program,” and “The AHA today expressed support for the Medicare Mental Health Inpatient Equity Act, a bill that would eliminate the 190-day lifetime limit on inpatient psychiatric hospital services for Medicare patients.” 
  • STAT News adds,
    • “Members of a [House Energy and Commerce oversight committee] said Tuesday that they fear public trust in organ donation has been fractured after a federal report found that an organ procurement organization ignored signs of life in patients when authorizing attempted organ removals.
    • “The hearing followed a federal investigation by the Health Resources and Services Administration that found that a group responsible for overseeing the removal of organs from deceased patients and getting them to patients in need exhibited “concerning patterns of risk to neurologically injured patients.” * * *
    • “During Tuesday’s hearing, lawmakers sharply questioned and criticized the practices of Network for Hope, the OPTN, and UNOS in conducting oversight of patient safety. The OPTN had launched a separate investigation into Network for Hope that was closed without further action.” 
  • Govexec informs us,
    • “The new, Senate-confirmed head of the Office of Personnel Management, venture capital alum Scott Kupor, says that he wants to operationalize the focus on efficiency in his agency and throughout government, but that OPM won’t be taking orders from the Department of Government Efficiency.
    • “OPM is its own agency,” Kupor told reporters Monday when asked about its relationship with DOGE moving forward. “To the extent that they’re helpful in the overall goals and objectives we have, then we’re happy to partner with people, but we’re going to ultimately make the decisions that we think are in the best interests of OPM.” * * *
    • “The agency is down by 322 employees since the start of Trump 2.0, OPM says. Once voluntary separations are finalized by the end of the year, OPM will be down from 3,110 employees when Trump took office to about 2,000, or around one-third of the agency, according to OPM.” * * *
    • “Kupor, who only started the job last week, said that he may have to make up for some of those losses. The agency is looking at what gaps in service exist, which need to be filled, which can be made up for with technology and what was “nice to have,” but not essential.” * * *
    • “We’ve got to really just rethink our entire recruiting efforts,” Kupor said. “I want every really smart person in this country to wake up every day and say, ‘you know what, I want to go work for the government because I can work on super hard problems that are very complex.’”
  • The AHA News relates,
    • “The AHA yesterday responded to a request for information from the Centers for Medicare & Medicaid Services on price transparency policy, specifically the accuracy and completeness of hospitals’ machine-readable files. The AHA said that determining the accuracy and completeness of machine-readable file data is challenging given that exact rates do not exist in the way they were envisioned by the policy. In addition, the AHA said that additional enforcement of hospital price transparency requirements is not necessary due to CMS’ improved enforcement efforts.  
    • “The AHA encouraged CMS to instead focus its efforts on the information that will best help patients understand and compare their expected costs prior to care and on streamlining price transparency policies to remove complexity and administrative burden.”

From the Food and Drug Administration front,

  • MedPage Today points out,
    • “Women should be better informed about the potential risks of using selective serotonin reuptake inhibitors (SSRIs) during pregnancy, and these risks should be weighed against their benefits, most speakers on an FDA panel selected by Commissioner Marty Makary, MD, MPH, agreed on Monday.
    • “Up to 5% of women in pregnancy are on an antidepressant. Antidepressants like SSRIs can be an effective treatment for depression,” said Makary during his opening remarks, though he warned that SSRIs “may be unique” because of their potential interaction with pregnancy.
    • “Serotonin may play a crucial role in the development of organs of a baby in utero, specifically heart, brain, and even the gut,” he continued. “SSRIs have also been implicated in different studies to be involved in postpartum hemorrhage, pulmonary hypertension, and cognitive downstream effects in the baby, as well as cardiac birth defects.”
  • STAT News reports,
    • “Sarepta Therapeutics, the maker of a gene therapy for Duchenne muscular dystrophy that is being temporarily shelved because of safety concerns, faces an “arduous and treacherous path” to try to get it back onto the market, a senior Food and Drug Administration official told STAT, suggesting the treatment’s license could be revoked. 
    • “The official, who spoke to STAT on condition of anonymity, did not rule out the possibility that the therapy, Elevidys, could eventually be brought back on the market. But it would be difficult for Sarepta to prove that any new safety protocols could eliminate the risk of liver injuries — which have been tied to the deaths of two patients — the official added.”

From the judicial front,

  • The Chief Judge for the Southern District of Iowa federal court entered a preliminary injunction today against certain provisions of a recently enacted Iowa PBM reform law that interfere with operations of ERISA governed health plans based on ERISA’s preemption law. The 87-page decision is well reasoned and quite balanced. What’s good for ERISA preemption is good for FEHB Act preemption.
  • Healthcare Dive reports,
    • “Humana on Monday refiled its lawsuit against the federal government for allegedly miscalculating its Medicare Advantage quality scores for 2025, after its previous suit was dismissed on procedural grounds.
    • “The new suit in a Texas district court is slimmer than its predecessor, focusing on allegations that regulators improperly dinged its plans’ star ratings on the basis of three mishandled customer service phone calls. The original suit made broader arguments about the integrity of the star ratings system and review process.”

From the public health and medical research front,

  • Cigna, writing in LinkedIn, discusses “the importance of treating both mental and physical health together.
  • USA Today lets us know,
    • “About five million swimming pools, specifically above-ground pools, have been recalled for a potential drowning risk after nine children died in a 15-year span.
    • “The impacted models include 48-inch and taller above-ground pools sold over the past two decades under the brand names Bestway, Coleman, Intex, and Polygroup, according to a release from the U.S. Consumer Product Safety Commission
    • “The CPSC believes between 2007 and 2022, nine children under 3 years old drowned after gaining access to the pools via compression straps that wrap around the outside of the product, according to the release.
    • “These straps wrap around the pool on the outside of the supporting poles, and may create a foothold, allowing a child to access the pool and drown,” the release said.”
  • STAT News reports,
    • “People suffering from long Covid finally had reason for hope: A German biotech had repurposed a drug candidate initially meant for heart disease as a potential treatment and enrolled patients in a rare double-blind Phase 2 study. For some participants, the results were transformative. One patient told Betsy Ladyzhets of The Sick Times that thanks to the infusion, BC 007, “I have literally regained life.”
    • “But last fall, the biotech company Berlin Cures abruptly announced the trial results were a failure, that it was out of money, and that it was done researching BC 007 as a treatment for long Covid. The story serves as a case study in the difficulty of developing long Covid therapies, as well as a window into the real-world impacts the hope and pain that clinical trials can inspire as they ramp up and then suddenly vanish. However, the drug may still have a future. Read more.“
  • and
    • “People with diabetes who were just a little physically active in their leisure time reduced their risk of dying from any cause — and from cardiovascular disease in particular — compared to people who weren’t active at all, according to a new Annals of Internal Medicine study that followed more than 51,000 people for 21 years. That benefit showed up for people who met the American Diabetes Association’s recommended 150 minutes of moderate to vigorous exercise a week over at least three days, but it was also apparent for “weekend warriors” who hit 150 minutes in just two days, matching research in people without diabetes. “Insufficiently active” types whose activity fell short of the 150 minutes per week also fared better than those who did no exercise.”
  • Per Medscape,
    • “Patients treated with tirzepatide have a significantly increased likelihood of attaining combined key therapeutic targets in the control of type 2 diabetes (T2D) compared with semaglutide, a post hoc analysis of the phase 3 SURPASS-2 trial showed. 
    • “In this post hoc analysis, we showed that tirzepatide was superior to semaglutide in achieving standard and intensive goals in type 2 diabetes control,” said first author Ana Rita Leite, MD, of the Department of Endocrinology, Diabetes, and Metabolism, São João Local Health Unit, Porto, Portugal, in presenting the findings at ENDO 2025: The Endocrine Society Annual Meeting.
    • “All doses of tirzepatide were superior in achieving these goals compared with semaglutide 1 mg, and there was a dose-dependent increase in the number of therapeutic goals attained with higher doses of tirzepatide,” she said.”
  • Per Health Exec,
    • “Researchers at the University of Florida College of Medicine have made a surprising finding that they say could “wake up” the immune system to fight cancer, possibly leading to a universal vaccine. 
    • “According to an announcement, a new study showed that an experimental vaccine developed using mRNA technology boosted tumor resistance in mice, when compared to a cohort that was given standard anti-cancer drugs. 
    • “The results seem to indicate the mice given the vaccine developed an immune response that allowed them to more effectively resist cancerous tumors. The findings were published in Nature Biomedical Engineering. [1]
    • “The promising results have spurred interest in how humans would react to the mRNA vaccine, with the researchers hoping it could be used as a treatment, either by itself or in conjunction with surgery, radiation and chemotherapy.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Ahead of the company’s second-quarter earnings call Aug. 6, Oscar Health is slashing its full-year guidance by about half a billion dollars.
    • “The insurer is expecting a loss from operations of $200 million to $300 million just months after estimating earnings from operations of $225 million to $275 million, partly due to elevated utilization.
    • “Oscar’s medical loss ratio is also climbing to between 86% and 87%, more than 5% higher than initially proposed. Total revenue is projected to climb to no more than $12.2 million.
    • “Wakely, an actuarial firm analyzing claims submissions through the end of April for Affordable Care Act (ACA) marketplace carriers, determined marketplace risk scores have risen more than Oscar previously estimated. The company foresees a net loss of $228 million for the second quarter.
    • “We are taking appropriate pricing actions for 2026 that reflect higher acuity in the individual market, and we will continue to take steps to deliver for our members, partners, and shareholders,” said Oscar Health CEO Mark Bertolini in a statement. “Oscar has successfully navigated dynamic markets before, and we remain committed to our long-term strategy to bring more employees, individuals, and families healthcare choices that fit their needs through the individual market.”
  • Per Drug Channels,
    • “It’s time for Drug Channels’ annual update on drug pricing trends at the largest pharmaceutical manufacturers.
    • “This year’s review includes the following nine companies: Bristol Myers Squibb, Eli Lilly and Company, Genentech, GlaxoSmithKline, Johnson & Johnson, Sanofi, Takeda, Teva, and UCB. You can find links to each company’s data below.
    • “These data highlight divergent trends reshaping the gross-to-net bubble:
      • “Rebates, discounts, and other fees reduced the selling prices of brand-name drugs at the biggest drugmakers to less than half of their list prices.
      • “When accounting for all list price reductions, average brand-name drug prices declined at four manufacturers and increased at five others. 
      • “Gross-to-net difference in price changes ranged from −12.8% to +4.2%, reflecting significant differences in the manufacturers’ portfolio mix and pricing strategies.”
  • Fierce Health adds,
    • “Humana is accelerating its efforts to reform the prior authorization process through a series of new policies, following the broader insurance industry’s recent pledge to reduce and streamline prior auth requirements.
    • “By January 1, 2026, Humana will eliminate one-third of prior authorization requirements for outpatient services, including for diagnostic services across colonoscopies, transthoracic echocardiograms, and select CT scans and MRIs. 
    • “Under the same timeline, the company is committing to providing decisions within one business day on at least 95% of all complete electronic prior authorization requests. Currently, a decision is provided within one business day on more than 85% of outpatient procedures.
    • “Also in 2026, Humana will launch a new gold card program that waives prior authorization requirements for certain items and services for providers with a record of submitting 
    • coverage requests that meet medical criteria and specific outcomes metrics for members.”
  • Fierce Pharma tells us,
    • “With the threat of tariffs looming for medicines imported to the United States, AstraZeneca has unveiled a plan to invest $50 billion in the country by 2030. The centerpiece of the effort is a drug substance manufacturing facility—the highest-priced plant in company history—that will be located at a yet-to-be-determined site in Virginia.
    • “The massive investment is part of a push by the company to generate $80 billion in sales by the end of the decade, with 50% of the haul coming in the United States. Last year, the British/Swedish company reported revenue of $54 billion, with U.S. sales accounting for 42% of the figure.”
  • BioPharma Dive reports,
    • “French pharmaceutical giant Sanofi said Tuesday it will pay $1.15 billion to acquire the privately held London-based private biotechnology company Vicebio and its portfolio of experimental vaccines.
    • “Through the deal, Sanofi will gain a combination shot now in clinical testing for protection against respiratory syncytial virus and human metapneumovirus, or hMPV. Vicebio specializes in a vaccine technology it dubs “molecular clamp.”
    • “Per deal terms, Vicebio could also receive up to $450 million in additional payments based on achievement of developmental and regulatory milestones. The companies expect the acquisition to close in the fourth quarter.”

Monday report

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

From Washington, DC

  • Fierce Healthcare reports,
    • “The Department of Health and Human Services said Monday it has launched “a major initiative” to overhaul the nation’s organ transplant system.
    • “The announcement cites an investigation conducted earlier this year by the department’s Health Resources and Services Administration (HRSA) “that revealed disturbing practices by a major organ procurement organization.”
    • “The news also came a day after a New York Times report that vividly described the case of a patient taken off life support and declared dead, but whose heart and respiratory system were found to still be active after surgeons had made an incision into her chest to secure her organs for donation.”

From the Food and Drug Administration front,

  • BioPharma Dive poses and answers five questions about Sarepta, the FDA and a Duchenne gene therapy crisis.
  • STAT News adds,
    • “Sarepta Therapeutics said Monday evening it will pause all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, acceding to a request made by the Food and Drug Administration after several patient deaths.
    • “It’s a surprising reversal by Sarepta. The company had initially rejected the agency’s request, which was issued Friday. 
    • “Shipments will halt by close of business Tuesday evening, the company said.
    • “The decision wasn’t entirely in Sarepta’s control. On Monday, Children’s Hospital Los Angeles (CHLA) said it was pausing use of Elevidys while the drug is in regulatory limbo. “Patient safety is paramount at CHLA and the hospital has communicated its decision with affected patient families while it awaits any further determination by the FDA,” the hospital told STAT.” * * *
    • “Sarepta did not indicate how long the Elevidys suspension might last. Ritu Baral, a biotech analyst at Cowen, estimated 3-6 months, during which time the company will test a proposed immune-suppressing protocol designed to mitigate the serious liver toxicity caused by the gene therapy, and share those data with the FDA.” 
       
  • Fierce Pharma tells us,
    • “FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and Research (CDER) in veteran biotech executive George Tidmarsh, M.D., Ph.D.
    • “Tidmarsh takes over CDER after a lengthy career in biotech and academia that saw the development of seven FDA-approved drugs, the formation of several biopharma companies and the establishment of Stanford University’s Master of Translational Research and Applied Medicine (M-TRAM) program.
    • “Some of the biopharma companies that Tidmarsh had a hand in founding and leading include Metronome Therapeutics, Revelation Biosciences and Horizon Therapeutics, which has since been picked up by Amgen for $27.8 billion. He’s been stationed at his alma mater at Stanford University’s School of Medicine for the last 15 years, most recently serving as an adjunct professor of pediatrics and neonatology.”

From the public health and medical research front,

  • The American Medical Association lets us know what doctors wish their patients knew about bronchitis.
  • The New York Times reports,
    • “[U]sing genetic data from five million people, an international group of hundreds of researchers reports that it has developed an obesity risk score, known also as a polygenic risk score. It combines thousands of gene variants to estimate individuals’ predicted body mass indexes, which continue to be used by doctors to anticipate weight-related health dangers.
    • “The researchers showed that the scores can predict which young children are at risk of obesity as adults. And, in another test, they found that overweight and obese adults with high-risk scores quickly regain any weight that they lose with lifestyle programs.
    • “Their paper was published on Monday in the journal Nature Medicine.”
  • Per Health Day,
    • “Doctors should ask diabetic women at every visit about their intention to have a child, to make sure they get the appropriate care prior to conception, new guidelines say.
    • “This will help avoid miscarriages and birth defects among women who have diabetes before pregnancy, the authors write in the Journal of Clinical Endocrinology & Metabolism.
    • “We developed these guidelines as diabetes rates are rising among women of reproductive age and very few women with diabetes receive proper preconception care,” lead author Dr. Jennifer Wyckoff, an endocrinologist at the University of Michigan in Ann Arbor, said in a news release.”
  • and
    • “Hispanic people are more likely to develop peripheral neuropathy than white people, and it’s not clear why, a new study has found.
    • “Hispanic folks were 32% more likely than white people to have this nerve disorder even after accounting for known health, lifestyle and social risk factors, researchers reported July 16 in the journal Neurology.
    • “It is likely that unknown social risk factors exist for this population,” lead researcher Evan Lee Reynolds, an assistant professor at Michigan State University in East Lansing, said in a news release. “Identifying additional risk factors for Hispanic people should be the focus of future studies.”
  • The Washington Post reports,
    • “Children with twice the level of the antimicrobial chemical triclosan in their urine were 23 percent more likely to report eczema symptoms than those with lower concentrations, according to research published in the journal Environmental Health Perspectives.
    • “Triclosan was commonly found in antibacterial soaps and body washes before 2016, when the Food and Drug Administration restricted its use in consumer wash products after finding that it was no more effective than standard soap and water. However, according to the Cleveland Clinic, triclosan can still be found in some toothpastes, deodorants, cosmetics and detergents.”
  • Per BioPharma Dive,
    • “A potential multibillion-dollar drug is advancing to late-stage testing now that its developer, Alkermes, has in hand positive results from a smaller study focused on a certain kind of narcolepsy.
    • “According to Alkermes, the study found all three doses of its drug under evaluation were significantly better than a placebo at improving scores on a test that places participants in a quiet, dark, peaceful room and monitors how awake and alert they are. Alkermes described the results as clinically meaningful and said all the drug-treated groups achieved “normative wakefulness” — in this case, taking more than 20 minutes to fall asleep.
    • “All doses of the drug, previously dubbed ALKS 2680 and now named alixorexton, were also generally well tolerated. Alkermes said there were no so-called serious treatment-emergent adverse events. Nor were there any treatment-related safety signals seen in participants’ vital signs, or on liver, kidney and eye exams.”
  • Per Fierce Pharma,
    • “AstraZeneca is raising its defenses against Johnson & Johnson in a fierce competition in EGFR-mutated non-small cell lung cancer.
    • “Following an FDA approval last year based on a tumor progression benefit, AZ said Monday that its Tagrisso combination with chemotherapy extended patients’ lives compared with Tagrisso alone in first-line advanced EGFR-mutated NSCLC.
    • “The readout came from the final overall survival analysis of the phase 3 Flaura2 trial, which had previously shown that the Tagrisso-chemo combo reduced the risk of disease progression or death by 38% versus Tagrisso monotherapy. The latest update found that the combo’s overall survival improvement was statistically significant and clinically meaningful, AZ said.”

From the healthcare business front,

  • Fierce Healthcare reports,
    • “UnitedHealthcare is rolling out a new benefit to encourage preventive cancer screenings.
    • “The insurer’s new breast and colon cancer detection benefit will be available for eligible commercial plans starting Jan. 1, 2026. Through the program, UHC will cover members’ first diagnostic imaging tests for breast cancer and diagnostic tests for colon cancer.
    • “This closes a care gap, UHC said, as follow-up testing may not be classified as a preventive service, which can lead to costs the member does not expect. Rhonda Randall, D.O., chief medical officer of UHC’s commercial business, told Fierce Healthcare in interview that concerns about costs can lead patients to skip key preventive services.
    • “We wanted to do remove that real or perceived barrier for beneficiaries,” Randall said.
    • “For example, about half of routine colonoscopies identify polyps that lead to follow-up testing, and 11% of mammogram screenings lead to additional imaging tests, both of which can draw higher costs if the resulting diagnostics are not covered as preventive.
    • “Under the new benefit, both the initial preventive screenings and follow-up testing will be covered at in-network providers, the insurer said.”
  • Axio tells us, “Hospitals are steadily buying small physician practices and, in the process, driving up the price of care, a new National Bureau of Economic Research study shows.”
  • MedCity News relates
    • CMS proposed a 2.4% Medicare payment increase for hospitals’ outpatient departments and ambulatory surgery centers in 2026, along with a new two-tiered physician reimbursement structure based on participation in value-based care models. Provider groups are welcoming the short-term boosts, but they fear the changes don’t go far enough to address their long-term financial pressures.
  • Beckers Hospital Review offers nine statistics from Press Ganey’s 2025 patient experience report.
    • “Press Ganey found higher scores in patient experience across all care settings in 2025, and a few metrics distinguish top-quartile facilities from the rest, according to a July 21 report. 
    • “Experience isn’t just a reflection of care — it’s the new frontier of care delivery,” Patrick Ryan, chairman and CEO of Press Ganey, said in a July 21 news release. “The systems that will lead in the next decade are those that approach trust, communication, and consistency not as soft skills, but as hard strategy. Our data makes it clear: when organizations embed experience into the core of how they deliver safe, high-quality care, they earn lasting loyalty and drive better outcomes cross the board.”
  • Per Fierce Pharma,
    • “Since starting operations in North Carolina 30 years ago, Biogen has spent approximately $10 billion to bolster its manufacturing presence in the Tar Heel state.
    • “But that’s not enough for the Massachusetts-based biotech, which says it will spend $2 billion more over the next three years, adding factories and upgrades at its two sprawling campuses in the Research Triangle Park (RTP).
    • “The investment pledge comes as biopharma companies respond to tariff threats from President Donald Trump by touting manufacturing expansions in the U.S.
    • “Biogen said the investment will fuel the advancement of its “late-stage clinical pipeline,” and will include expansion of its antisense oligonucleotide (ASO) capabilities and infrastructure. ASOs are snippets of RNA and DNA used in the development and production of gene therapies and cancer treatments.”

Weekend update

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–

From Washington, DC

  • Roll Call discusses expected floor activities this week on Capitol Hill.
  • The House Financial Services and General Government Subcommittee of the House Appropriations Committee will meet on Monday July 21 to mark up its appropriations bill which includes OPM appropriations.
    • The bill includes the following FEHB Program measures
      • Ban on applying full federal cost accounting standards on FEHB and PSHB carriers (Sec. 611).
      • Banning abortion coverage except “where the life of the mother would be endangered if the fetus were carried to term, or the pregnancy is the result of an act of rape or incest. (Sec. 614, also known as the Hyde Amendment).
      • A contraception mandate with certain exceptions (Sec. 726) which has been modified by the Affordable Care Act’s contraception mandate.
      • A new ban for 2026 (Sec. 761) which reads as follows:
        • “None of the funds made available by this Act, or in any previous appropriation, may be provided for in 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.”
  • OPM Director Scott Kupor has begun writing a weekly blog about OPM. Here is a link to his first post which is worth reading. 
  • USA Today reports,
    • “Social Security recipients could get a 2.7% raise next year, up from last month’s estimate of 2.5%, based on the latest inflation report, according to a new estimate.
    • “The Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W), the index used to calculate the annual adjustment to Social Security benefits, gained 2.6% in June. Overall inflation rose 2.7%from May’s 2.4% increase. The Federal Reserve’s inflation goal is 2%.” * * *
    • [However,] Medicare Part B costs are rising several times faster than its average rate of increase in recent years.
    • “According to the 2025 Medicare Trustees annual report released in June [2025], the Medicare Part B premium for 2026, is expected to increase to $206.50 from $185.00 in 2025 for a jump of $21.50 per month, or 11.6%. That’s the largest Part B increase since 2022 when it rose 14.5%.” 
  • MedTech Dive informs us,
    • “A warning letter sent by the Food and Drug Administration to wearable company Whoop has sparked a debate on when wellness claims should be regulated as medical devices.
    • Whoop, a company selling a wearable wristband to track metrics such as sleep, heart rate and strain, received the warning letter on Monday for marketing a blood pressure insights feature without FDA authorization. 
    • “The feature provides daily systolic and diastolic blood pressure estimates by measuring heart rate variability during sleep. Whoop’s website states that the feature is intended to help users track blood pressure trends and have a deeper understanding of how blood pressure affects their wellness. The website also marketed the feature as an example of how Whoop is “delivering medical-grade health & performance insights,” according to the warning letter. 
    • “In a response posted Tuesday, one day after the letter was sent to the company, Whoop said it disagrees with the FDA’s assertion that the blood pressure feature should be reviewed as a medical device before being available in the U.S., claiming it is a wellness feature, not a medical device.
    • “This interpretation is also inconsistent with the 21st Century Cures Act, which clarifies that functions intended to promote a healthy lifestyle — and unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition — are excluded from the definition of a medical device,” a Whoop spokesperson wrote in an emailed statement.” 

From the public health and medical research front,

  • The New York Times reports,
    • “Across the United States, an intricate system of hospitals, doctors and nonprofit donation coordinators carries out tens of thousands of lifesaving transplants each year. At every step, it relies on carefully calibrated protocols to protect both donors and recipients.
    • “But in recent years, as the system has pushed to increase transplants, a growing number of patients have endured premature or bungled attempts to retrieve their organs. 
    • “Across the United States, an intricate system of hospitals, doctors and nonprofit donation coordinators carries out tens of thousands of lifesaving transplants each year. At every step, it relies on carefully calibrated protocols to protect both donors and recipients.
    • “But in recent years, as the system has pushed to increase transplants, a growing number of patients have endured premature or bungled attempts to retrieve their organs. 
    • “Circulatory death donation is different. These patients are on life support, often in a coma. Their prognoses are more of a medical judgment call.
  • The FEHBlog certainly will be taking another look at his living will.
  • NPR Shots tells us
    • “After about age 40, our brains begin to lose a step or two.
    • “Each year, our reaction time slows by a few thousandths of a second. We’re also less able to recall items on a shopping list.
    • “Those changes can be signs of a disease, like Alzheimer’s. But usually, they’re not.
    • “Both of those things, memory and processing speed, change with age in a normal group of people,” says Matt Huentelman, a professor at TGen, the Translational Genomics Research Institute, in Phoenix.
    • “Huentelman should know. He helps run MindCrowd, a free online cognitive test that has been taken by more than 700,000 adults.”
    • “About a thousand of those people had test scores indicating that their brain was “exceptional,” meaning they performed like a person 30 years younger on tests of memory and processing speed.
    • “Genetics played a role, of course. But Huentelman and a team of researchers have been focusing on other differences.” * * *
    • “Early results suggest that sleep and maintaining cardiovascular health are a good start. Other measures include avoiding smoking, limiting alcohol and getting plenty of exercise.”
  • New York Times Well lets us know “Want More Self-Control? The Secret Isn’t Willpower. People who can delay gratification and master their impulses thrive in life. And experts say that you can learn skills to rein in bad habits.”
  • The Wall Street Journal reports,
    • “Long contentious, chronic Lyme, as it is called by patient advocates, has gained more acknowledgment and investment by researchers after Covid-19 showcased how an infection can leave people with lingering symptoms that last months or longer. The virus’s aftermath looked strikingly similar to what some Lyme disease patients had been describing for years.
    • * * * “In May, the National Academies of Sciences, Engineering and Medicine published a report saying that research funders should put more emphasis on developing treatments for patients with lingering symptoms after Lyme disease, even as the root cause behind why patients experience the symptoms remains a mystery.” * * *
    • “Some laboratory researchers are investigating what might be behind the symptoms, including whether a molecule that the bacteria left behind could be driving inflammation. Newer trials are now looking at whether certain antibiotics or electrical nerve stimulation might help treat the condition, since persistent infection and immune-system or neural-network dysfunction are also theories doctors have proposed. Prior trials haven’t found a benefit to more antibiotics after initial treatment.
    • “We’re not just focusing on one mechanism but many different possible mechanisms as to why people might have persistent symptoms,” said Dr. Brian Fallon, director of the Lyme and Tick-Borne Disease Research Center at Columbia University and head of the Lyme-focused clinical trial network that launched in 2021. 
    • “Preventing tick bites remains a person’s best defense against Lyme and other tickborne diseases. People should avoid wooded and brushy areas with high grass, walk in the center of trails and cover up extremities, health officials say. Wearing insect repellent, checking your body for ticks and showering soon after being outdoors also help reduce the risk.”
  • Modern Healthcare relates,
    • “People are beginning to trust AI for getting their health information, according to survey data from the Annenberg Public Policy Center of the University of Pennsylvania. Nearly eight out of 10 U.S. adults say they’re likely to look online for the answer to a question about a health symptom or condition. Of who are using AI, 75% say that AI-generated responses provide them with the answer they need. Most Americans (63%) think AI-generated health information is reliable.”

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, Mental health care, NCQA, NIH, No Surprises Act, OPM, U.S. Healthcare–

From Washington, DC,

  • Govexec reports,
    • “President Trump created another new category of federal employee on Thursday evening, issuing an executive order to expand the number of political appointees who do not require Senate confirmation and will serve in policy-making or policy-advocating roles. 
    • ‘While presidents can already tap an uncapped number of appointees to serve in Schedule C positions, Trump noted those individuals serve in more narrow confidential or policy-determining roles. The new positions will therefore fill a gap that currently exists in federal appointments, the White House said. 
    • “The order is the latest in Trump’s effort to establish a tighter grip on the executive branch and its actions. He has already created Schedule Policy/Career, formerly known as Schedule F, which is similarly defined to Schedule G but reserved for career civil servants. Agencies are in the process of determining who qualifies for conversion to Schedule Policy/Career and those employees will become easier to fire for any reason.” 
  • Federal News Network tells us,
    • “The Postal Service’s new chief executive is defending the agency’s current operating model, at a time when the Trump administration considers challenging its independence.
    • “David Steiner, former FedEx board member and Waste Management CEO, began his tenure as postmaster general on Tuesday.
    • “Steiner told employees Thursday he supports keeping USPS independent from the executive branch and defended the 10-year reform plan of his predecessor, former Postmaster General Louis DeJoy.
    • “Steiner told employees in a video message on Thursday that, “I do not believe that the Postal Service should be privatized, or that it should become an appropriated part of the federal government.”
    • “I believe in the current structure of the Postal Service as a self-financing, independent entity of the executive branch,” Steiner said. “My goal for the Postal Service is to meet the financial and service performance expectations of our nation under this structure.”
  • The American Hospital Association News informs us,
    • “Health Insurance Marketplace insurers will propose a median premium increase of 15% for 2026, according to an analysis of preliminary rate filings published July 18 by the Peterson Center on Healthcare and KFF. It would be the largest hike in premiums since 2018, the report said. Factors cited for the increase include the scheduled expiration of enhanced premium tax credits and impacts from tariffs. The analysis found that the expiring tax credits would increase out-of-pocket premium payments by more than 75% on average, while tariffs could increase the cost of certain drugs, medical equipment and supplies.”
  • The Centers for Medicare and Medicaid Services shares highlights from its 2025 Quality Conference held earlier this month.
  • KFF, writing in Fierce Healthcare, criticizes the No Surprises Act. No law is perfect.

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to BioPharma Dive.
    • “Sarepta last month paused shipments for certain older Duchenne patients following the death from acute liver failure of a second teenager treated with the therapy, called Elevidys. The FDA subsequently began a formal investigation of Elevidys’ liver risks. 
    • “Reuters first reported news of the FDA’s request. FDA Commissioner Martin Makary told Bloomberg in an interview Friday that his agency is weighing whether to withdraw Elevidys from the market entirely. 
    • “The news comes on the heels of Sarepta reporting this week the death of a 51-year-old man who received an experimental gene therapy it’s developing for another kind of muscular dystrophy known as limb-girdle. The man died of complications from acute liver failure in June. 
    • “While the two treatments are constructed differently, they both use the same kind of engineered virus to deliver a replacement gene to the body’s muscles.”
  • The New York Times adds,
    • In a remarkable public dispute between drugmaker and regulator, the biotech company Sarepta Therapeutics is defying the Food and Drug Administration’s request that it halt distribution of its treatment for a deadly muscle-wasting disease.
    • In a news release on Friday evening, the agency said that it requested that the company voluntarily stop all shipments of the therapy, known as Ele­vidys, citing the deaths of three patients from liver failure who had taken the product or a similar therapy.
    • In its own news release later on Friday evening, Sarepta, which is based in Cambridge, Mass., said that it would continue to ship the treatment for patients who do not use wheelchairs. The company said its analysis showed no new safety problems in those patients and that it was committed to patient safety.
  • BioPharma Dive points out,
    • “A panel of medical experts called for the removal of warning labels on hormone therapy for menopausal women during a meeting convened Thursday by the Food and Drug Administration.
    • “Led by FDA Commissioner Martin Makary, the meeting focused on the benefits and risks of menopause hormone therapy, or MHT, which has become a controversial topic due to mixed study data.
    • “The panel, which consisted of 12 experts with various medical backgrounds, took a generally positive view of MHT and described situations in which patients experienced severe symptoms could not get access to treatment.”
  • Healthexec notes,
    • “The U.S. Food and Drug Administration announced a recall of multiple active glucose monitoring units manufactured by Dexcom due to a malfunction in the receivers. The speakers on these devices may fail to alert wearers when blood sugar levels become dangerously high or low. Typically, the monitors emit an alert sound; however, in Dexcom G6, G7, ONE and ONE+ products, reports indicate that the alarms do not always function properly.
    • “There have been at least 56 injuries associated with the error, the FDA said. However, no deaths have been reported.”
  • Reuters adds,
    • “The U.S. Food and Drug Administration approved a pre-filled syringe version of GSK’s (GSK.L)  blockbuster shingles vaccine Shingrix, providing patients a more convenient option to receive the shot, the company said on Thursday.”

From the judicial front,

  • Healthcare Dive reports,
    • “A Texas federal judge has dismissed Humana’s lawsuit against the federal government seeking to improve its Medicare Advantage star ratings, in a significant loss for the insurer.
    • “Humana sued the CMS in October 2024 to reverse its quality scores, arguing that the agency acted arbitrarily and capriciously in downgrading the ratings, which are tied to billions of dollars in reimbursement, for 2025.
    • “However, District Judge Reed O’Connor ruled on Friday that Humana failed to exhaust administrative remedies before filing its lawsuit. Humana said it is exploring further legal action.”
  • Bloomberg Law lets us know,
    • “A federal judge refused Friday to remove an order that halted US Health Secretary Robert F. Kennedy Jr. from carrying out mass firings and restructuring across health agencies. 
    • “The US District Court for the District of Rhode Island disagreed with the Justice Department’s request to lift the order due to pending stays in two other cases that challenge with government’s reduction-in-force. Those cases are McMahon v. New York , regarding layoffs at the Department of Education, and Trump v. AFGE, regarding President Donald Trump’s reorganization of the federal government.” * * *
    • “Defendants misguidedly argue that the Supreme Court’s recent grants of stays pending appeals” in those cases mean that the court should immediately reverse its July 1 decision granting plaintiffs’ preliminary injunction, Judge Melissa R. DuBose for the US District Court for the District of Rhode Island said in the order. * * *
    • “DuBose rejected the government’s request to stay pending the appeal.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is increasing in many Southeast, Southern, and West Coast states. 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 young children 0-4 years old. COVID-19 wastewater activity levels and model-based epidemic trends (Rt) indicate that COVID-19 infections are growing or likely growing in many Southeast, Southern, and West Coast states.
    • “Influenza
    • “RSV
      • “RSV activity is very low.
  • The University of Minnesota’s CIDRAP tells us,
    • “Only 35% to 40% of US pregnant women and parents of young children say they intend to fully vaccinate their child, per survey results from researchers at Emory University and the Centers for Disease Control and Prevention (CDC).
    • “For the two surveys, published as a research letter this week in JAMA Network Open, the investigators recruited 174 pregnant women and 1,765 parents from a nationally representative panel in April 2024 to answer questions about their intent to have their child receive all recommended vaccines by 18 months.
    • “Many parents in the US choose to delay or refuse vaccines that are recommended for their child from birth to age 18 months,” the study authors wrote. “Research is necessary to understand the value of intervening during pregnancy to proactively support parents with vaccination decisions before the birth of the child, as implementation of such interventions will require substantial engagement of health care professionals and entities outside of the pediatric care setting.”
  • Per an NIH news release,
    • “Sjögren’s disease is a chronic autoimmune condition affecting up to four million Americans, characterized by symptoms such as dry eyes and mouth, fatigue, and inflammation in various organs. Although it primarily affects women, men tend to face more severe complications. The disease can impact pregnancy outcomes and increase risk for lymphoma. Despite extensive research, its underlying causes remain unclear, and current treatments mainly aim to manage symptoms.
    • “Recent NIH-supported research using mouse models sheds new light on Sjögren’s disease, pointing to dysfunction in regulatory T cells and a heightened interferon gamma response as key drivers of disease symptoms. A drug called baricitinib, already approved for conditions such as rheumatoid arthritis, showed promising results in mice by reducing inflammation and restoring gland function. The similarities between mouse and human immune responses suggest that baricitinib could be a viable future treatment for people with Sjögren’s disease, offering hope for more targeted therapies ahead.”
  • The Washington Post reports,
    • “A baby’s sex may not be up to mere chance.
    • “A study published Friday in the journal Science Advances describes the odds of having a boy or girl as akin to flipping a weighted coin, unique to each family. It found evidence that an infant’s birth sex is associated with maternal age and specific genes.
    • “The findings challenge assumptions that birth sex is random. They mirror the results of similar studies in Europe that have also found that birth sex does not follow a simple 50-50 distribution.”

From the U.S. healthcare business front,

  • The New York Times reports,
    • “Prescription drug denials by private insurers in the United States jumped 25 percent from 2016 to 2023, according to a new analysis of more than four billion claims, a practice that has contributed to rising public outrage about the nation’s private health insurance system.
    • “The report, compiled for The New York Times by the health analytics company Komodo Health, shows that denial rates rose from 18.3 percent to 22.9 percent. The rejections went up across many major health plans, including the country’s largest private insurer, UnitedHealthcare.” * * *
    • “The analysis found that the most common reason for a drug claim to be rejected was that a refill had been requested “too soon,” before the patient was eligible for more medication.”
    • “Appropriate prescription drug denials can happen for numerous reasons, and many can be resolved within minutes,” said Greg Lopes, a spokesman for the Pharmacy Care Management Association, a trade group for pharmacy benefit managers.”
  • Beckers Payers Issues gives us a look inside the Humana-Mercy partnership “that’s shaping the future of health care.”
  • Behavioral Health Business tells us,
    • “Lyra Health, a national provider of mental health benefits for employers, has acquired Bend Health with the goal of strengthening its pediatric and neurodiversity capabilities. 
    • “Lyra’s acquisition of Madison, Wisconsin-based Bend Health was completed July 16. Exact terms of the deal were not disclosed in the press release.
    • “The move enables Lyra to utilize Bend Health’s collaborative care model and specialized providers to offer more comprehensive evaluations and virtual intensive outpatient care to its 20 million members.”
  • NCQA, writing in LinkedIn, discusses a new look for HEDIS that will arrive on August 1.

Thursday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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