Thursday Report

COVID-19

Thursday Report

David Ermer–Congress, COVID-19 testing, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Modern Healthcare reports,
    • “Senate Republicans are considering cuts to Medicare spending to help pay for Donald Trump’s signature legislative package.
    • “The GOP lawmakers are proceeding cautiously as they expand their search for savings to a popular health insurance program nearly all Americans rely upon in retirement, presenting the move as an effort to root out waste, fraud and abuse. That includes cutting payments to health insurance companies that run private Medicare plans.”
  • The Wall Street Journal adds,
    • “Humana, the second-biggest Medicare insurer, has told congressional staffers that it will support moves that would curtail billing practices worth billions in extra payments to the industry, according to staffers and a document viewed by The Wall Street Journal.
    • “The stance by a leader in the Medicare Advantage business—in which insurers offer privately run Medicare plans—represents an important development in a growing debate over how the companies are paid in the $460 billion program.
    • “Insurers get paid more for covering sicker patients in Medicare Advantage, giving companies an incentive to record more diagnoses. Humana has told congressional staffers that it is willing to back new limits on lucrative payments insurers can gain from diagnoses recorded by nurse practitioners who visit millions of enrollees in their homes, according to a one-page policy overview shared with congressional staffers.
    • “After the Journal published this article Thursday morning, the biggest Medicare insurer, UnitedHealth Group, posted a statement saying that it too would support a new limit on the use of diagnoses from home visits.”
  • Healio points out,
    • HHS has ended a government-funded program that distributed free COVID-19 tests to community organizations, a department spokesperson confirmed to Healio.
    • “With COVID-19 behaving more like the seasonal flu — rising and falling through the year — and tests widely available at retail stores nationwide, continued federal distribution is a significant waste of taxpayers’ dollars,” the spokesperson said. “The COVID-19 pandemic is over.” * * *
    • “The program differed from the mail-based program that was started and stopped several times throughout the pandemic and provided U.S. residents the opportunity to get free COVID-19 tests delivered directly to their homes.”
    • “HHS is in the process of purchasing a supply of tests that can distinguish between COVID-19 and influenza to have on hand for emergencies.”
  • Tammy Flanagan, writing in Govexec, discusses “Should you stay, or should you go? 10 tips for navigating your federal retirement decision. What to consider—financially and emotionally—before leaving government service.”

From the public health and medical research front,

  • Chief Healthcare Executive tells us,
    • Two years ago, the American Diabetes Association and The Leapfrog Group announced that they were joining forces to recognize hospitals for providing excellent care to patients with diabetes.
    • Now, the groups are announcing honors for a second batch of recipients, and they’re recognizing more than twice as many hospitals.
    • The American Diabetes Association and the Leapfrog Group have announced 36 hospitals as 2025 Recognized Leaders in Caring for People Living with Diabetes. A year ago, the groups recognized 17 hospitals [which are listed in the article].
    • The organizations say they want to give public recognition to hospitals, but they are also highlighting the importance of providing proper care for patients with diabetes.
    • Nearly one-third of patients admitted to hospitals (30%) are diagnosed with diabetes. Some of those are patients that are being treated in the hospital for another illness or injury.
  • The New York Times reports,
    • “The technology that powered Covid vaccines may also lead scientists to a cure for H.I.V. Using mRNA, Australian researchers said they were able to trick the virus to come out of hiding, a crucial step in ridding the body of it entirely.
    • “The research, published last week in Nature Communications, is still preliminary, and so far, has been shown to be successful only in a lab. But it suggests that mRNA has potential far beyond its use in vaccines as a means to deliver therapies against stubborn adversaries.
    • “Short for messenger RNA, mRNA is a set of instructions for a gene. In the case of Covid vaccines, the instructions were for a piece of the coronavirus. In the new study, they are for molecules key to targeting H.I.V.
    • “Dr. Sharon Lewin, director of the Cumming Global Center for Pandemic Therapeutics in Melbourne, who led the study, called mRNA a “miraculous” tool “to deliver things that you want into places that were not possible before.”
  • STAT News adds,
    • “People with diabetes who were taking GLP-1 drugs had a low but elevated risk of an age-related eye disease that can sometimes lead to blindness, a new observational study concludes, adding to a short list of concerns about eye health in people taking the powerful medications.
    • “The research, published Thursday in JAMA Ophthalmology, found that after one year, more than twice as many people on GLP-1 drugs developed neovascular age-related macular degeneration compared to similar people who were not taking the drugs. The risk was 0.2% in people taking GLP-1s and 0.1% in those who didn’t. Participants, drawn from health records of nearly 140,000 patients in Canada, were matched for socioeconomic status and a long list of conditions in addition to diabetes.” * * *
    • “Seeing such a clear signal in our study was striking,” co-author Reut Shor of the University of Toronto told STAT. “The absolute risk remains low, but the advanced form of AMD is a condition with serious implications for vision and quality of life. So a doubling of risk is clinically meaningful, particularly for vulnerable populations like older adults who may already be at elevated baseline risk.”
  • Per Health Day,
    • “A quality improvement strategy can improve electronic health record-based screening for depression and anxiety in people with epilepsy, according to a study published online April 16 in the Journal of Clinical and Translational Science.
    • “Heidi M. Munger Clary, M.D., M.P.H., from the Wake Forest University School of Medicine in Winston-Salem, North Carolina, and colleagues developed an implementation strategy for anxiety and depression screening among people treated at an epilepsy center. Implementation outcomes were evaluated five months postimplementation compared to two three-month preimplementation time frames.”
  • and
    • Dietary patterns seem to be associated with depressive symptoms, according to a study published online June 3 in BMJ Nutrition, Prevention & Health.
    • Gabriella Menniti, M.D., from Unity Health Toronto, and colleagues conducted a cross-sectional study using National Health and Nutrition Examination Survey 2007 to 2018 data to examine the association between restrictive dietary patterns and depressive symptoms stratified by sex and body mass index.
  • Per MedPage Today,
    • High blood pressure (BP) awareness increasingly slipped under the radar since the COVID-19 pandemic, according to nationally representative health data.
    • Results from National Health and Nutrition Examination Survey (NHANES) cycles, spanning the years 2013 to 2023, showed no improvement in the proportion of adults having hypertension, diabetes, and high cholesterol who self-reported being unaware and never diagnosed. In fact, hypertension awareness stood out for trending significantly in the wrong direction:
      • Adults with hypertension not realizing it: 14.6% in 2013-2014 to 17.8% in 2021-2023
      • Adults with diabetes not realizing it: 27.5% to 28.9%
      • Adults with high total cholesterol not realizing it: 11.5% to 11.9%
    • “Given declining cardiometabolic health in young adults, it is concerning that approximately one in three with hypertension, two in five with diabetes, and one in four with a high cholesterol level are unaware of having these conditions. Policy efforts to address these gaps in awareness are needed to prevent future cardiovascular events,” wrote Rishi Wadhera, MD, MPP, MPhil, of Beth Israel Deaconess Medical Center and Harvard T.H. Chan School of Public Health in Boston, and colleagues in JAMA Cardiology“

From the U.S. healthcare business front,

  • Beckers Hospital Review informs us,
    • “Nonprofit hospitals are seeing margins improve as patient demand for care soars, according to Kaufman Hall’s “National Hospital Flash Report” released June 5.
    • “Kaufman Hall, a Vizient company, analyzed data from 1,300 hospitals collected by Strata Decision Technology for its monthly report.
    • “Hospital performance from January to April outpaced the first four months of 2024, largely driven by patient volume and hospital efficiency,” said Erik Swanson, managing director and group leader, data and analytics, at Kaufman Hall. “Operating room minutes, ED visits and inpatient revenue are trending upward, demonstrating a strong demand for services. A decline in average length of stay indicates that hospitals are triaging, treating, and discharging patients effectively and appropriately.”
  • Modern Healthcare reports,
    • “Nineteen critical access hospitals in Nebraska have formed a clinically integrated network, the third coalition of its kind created over the past three months.
    • “The Nebraska High Value Network aims to give rural hospitals the scale to lower costs, invest in new technology, improve treatment and expand value-based contracts while remaining independent. The network, announced Thursday, follows similar alliances in Montana, Ohio, Minnesota and North Dakota.” * * *
    • “Cibolo Health, the rural health advisory firm that helped launch these hospital collaborations, will manage daily operations of the Nebraska High Value Network. The network will include clinical and business integration committees led by member hospital executives who will oversee quality and administrative initiatives.”
  • Beckers Clinical Leadership lets us know,
    • “The District of Columbia has the most physicians per 100,000 population, while Idaho has the fewest specialist physicians and Nevada has the fewest primary care physicians per 100,000, KFF data found.
    • “KFF used data from Redi-Data to find the number of MD and DO active state-licensed physicians as of April 2025. Becker’s used Census data from 2025 to find the population of each state.
    • “There are 535,542 primary care physicians and 570,655 specialist physicians in the U.S. this year.
    • “[The article includes a chart with] the number of primary care and specialist physicians per 100,000 people in each state and the District of Columbia.”
  • Per MedTech Dive,
    • “Johnson & Johnson CFO Joseph Wolk, at the Bernstein investor conference last week, tempered the company’s expectation that it would suffer a $400 million tariff impact this year.
    • “Wolk gave the update after the U.S. and China reached a temporary agreement to pause escalating tariff rates between the two countries for 90 days.
    • “Weeks before the pause, J&J had predicted on an April’s earnings call that it would incur tariff-related costs of about $400 million this year, primarily affecting its medtech business.
    • “But Wolk, at the Bernstein conference, suggested the forecasted tariff hit could change in the future.
    • “Just based on the retaliatory China tariffs that we had in our $400 million assessment, that probably cuts the $400 million down to $200 million,” Wolk said, responding to a question about the shifting tariffs landscape. That does not include any impact that could result from the Trump administration’s Section 232 investigations, he said. The Trump administration has launched special investigations into the pharmaceutical and semiconductor industries that could lead to tariffs.
    • “In addition, Wolk noted, tariffs between the U.S. and Europe remain in flux.” 

Weekend update

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

From Washington, DC

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday Report

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

In Food and Drug Administration news,

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

From the public health and medical research front,

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

Fromm the U.S. healthcare business front,

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

Midweek update

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Mental health care, No Surprises Act, SCOTUS, Telehealth, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Washington, DC,

  • Bloomberg Law tells us,
    • US Health Secretary Robert F. Kennedy Jr.’s decision to pull the Covid-19 vaccine from the CDC’s recommended immunization list for healthy children and pregnant women means health plans must navigate whether to keep providing coverage for the shot. * * *
    • “Kennedy’s announcement in a video posted on X appeared to skip recommendations from the Advisory Committee on Immunization Practices, a panel of outside medical experts who guide the CDC on vaccine policy and vote for any new or updated recommendations to the schedule.
    • “The ACIP holds weight because the Affordable Care Act and the Inflation Reduction Act tie coverage in the commercial and Medicaid markets to the committee’s recommendations, attorneys say. That committee also votes on whether vaccines should be added to the federal Vaccines for Children program, which provides vaccines to children who can’t to afford them. 
    • “The panel is currently scheduled to meet starting June 26 to consider Covid-19 vaccines.
    • “The HHS did not respond to request for comment on further details of the announcement.”
  • Fierce Pharma informs us,
    • “While the Trump administration’s threat of pharmaceutical import tariffs and most favored nation (MFN) drug pricing has weighed heavily on the pharmaceutical industry in recent months, many branded drugmakers are well-positioned to handle the pressures.
    • “That was the perspective offered in a new report by S&P Global, which suggests that many global pharma companies can endure pricing pressures, trade duties and more, and that some of the most concerning policies floated by President Donald Trump are unlikely to materialize as planned.
    • “Still, Trump’s ambition to impose a most favored nation (MFN) drug pricing policy—which would attempt to close the gap between the costs of U.S. drugs and those in other countries—would be “highly negative” to branded drugmakers’ credit quality if enacted, the S&P team cautioned.”

In Food and Drug Administration news,

  • BioPharma Dive lets us know,
    • “Abbott said Tuesday it received Food and Drug Administration approval for the Tendyne transcatheter mitral valve replacement system to treat calcium buildup in the ring that supports the heart valve.
    • “The device is available for patients with severe mitral annular calcification who are not candidates for open heart surgery or transcatheter mitral valve repair.
    • “Abbott’s MitraClip system for mitral valve repair competes with Edwards Lifesciences’ Pascal repair device. The rivals are now set to compete in mitral valve replacement: Edwards won Europe’s CE mark last month for the Sapien M3 transfemoral system and expects U.S. approval in 2026.”
  • and
    • “Boston Scientific said Wednesday it plans to end worldwide sales of its transcatheter aortic valve replacement systems, citing regulatory hurdles. The company will discontinue its Acurate Neo2 and Acurate Prime TAVR systems, which are sold in Europe, and will not pursue Food and Drug Administration approval for the devices. 
    • “Boston Scientific said in a regulatory filing that the decision followed recent discussions with regulators, adding that the products faced increased requirements to maintain approvals in global markets and to obtain approvals in new regions.”

From the judicial front,

  • Yesterday, the U.S. Solicitor General filed with the Supreme Court a requested amicus brief recommending that the Court not review a U.S. Court of Appeals for the 10th Circuit decision that overrode parts of Oklahoma’s PBM reform law based on ERISA and Medicare preemption. The Supreme Court is likely to make a ruling on this issue next month. The FEHBlog is happy about this development.
  • Modern Healthcare reports,
    • “An Elevance Health subsidiary is suing the billing dispute consulting company HaloMD and two hospital-based Georgia providers, alleging they conspired to exploit the No Surprises Act.
    • “Blue Cross Blue Shield Healthcare Plan of Georgia, which operates under Elevance Health’s Anthem brand, filed the suit in the U.S. District Court for the Northern District of Georgia on Tuesday. The company alleges HaloMD and its out-of-network clients inappropriately won higher reimbursements through the No Surprises Act’s independent dispute resolution, or IDR, system.
    • “Defendants procured improper payments from [Blue Cross Blue Shield of Georgia] on thousands of disputes. Indeed, nearly 70% of disputes on which defendants received an IDR payment determination were clearly ineligible for the process. Since 2024, defendants’ scheme has caused millions of dollars in damages, and it continues to harm [Blue Cross Blue Shield of Georgia], employer plan sponsors and other managed care companies,” the insurer wrote in its complaint.
    • “Elevance Health estimates it spent $5.9 million on excess reimbursements and IDR fees from Jan. 3, 2024, to April 29, 2025.”
    • Unquestionably the IDR system needs to become more transparent to the parties.

From the public health and medical research front,

  • ABC News relates,
    • “About a month ago, the rate of new measles cases was accelerating at a seemingly unprecedented rate with more than 100 infections being confirmed every week.
    • “However, over the last couple of weeks, the rate of newly confirmed cases appears to be slowing.
    • “The Centers for Disease Control and Prevention (CDC) confirmed an average of 22 weekly cases over the last two weeks.
    • “Even in western Texas, which had been driving most new cases in the U.S., about 11 cases have been confirmed since May 23.
    • “Public health experts told ABC News they believe measles cases are slowing down due to a mix of vaccination, a build of natural immunity and people staying home when sick.”
  • The Washington Post points out,
    • “Scores of researchers have produced new tools that can deliver genes and selectively activate them in hundreds of different cell types in the brain and spinal cord, a breakthrough that scientists hope advances them toward developing targeted therapies to treat neurodegenerative diseases such as ALS, Parkinson’s disease and Alzheimer’s.
    • “The discoveries, made through the National Institutes of Health’s BRAIN initiative, show with unprecedented clarity and precision how neural cells work together, but also how diseases disrupt their tight choreography. The insight offers the promise that doctors may one day treat diseases by manipulating dysfunctional cells.
    • “Looking ahead, with sustained investment, the advances we can achieve in understanding consciousness — and in repairing neurological and neuropsychiatric disorders — will be nothing short of life-changing,” Gord Fishell, a professor of neurobiology at Harvard Medical School and one of the scientists involved in the discoveries, said in an interview for the BRAIN webpage. “This will revolutionize both our grasp of how the brain works and our ability to treat currently intractable conditions.”
  • Per MedPage Today,
    • “Self-reported maternal mental health declined in recent years, as did maternal physical health, though less drastically, a cross-sectional study suggested.
    • “After adjustments for secular changes in sociodemographic groups, “excellent” physical health decreased by 4.2 percentage points, “excellent” mental health decreased by 12.4 percentage points, and “fair/poor” mental health increased by 3.5 percentage points from 2016 to 2023, reported Jamie Daw, PhD, of the Columbia University Mailman School of Public Health in New York City, and colleagues in JAMA Internal Medicine.
    • “Daw told MedPage Today that this decline in mental health was even greater than what she and her team were expecting to find. Recent research has focused on the impacts of the COVID-19 pandemic on mental health, but this study indicated that the downward population-level trends were happening before 2020.
    • “This is not just a pandemic story — it’s much broader than that,” Daw said. “This study helps us expand our thinking about when we should be caring about the health of mothers, and in pointing out that it is well beyond the perinatal period.”
  • and
    • “For patients with major depression, there was a clinically meaningful but not statistically significant improvement in the primary endpoint with 20-mg azetukalner.
    • “There were significant improvements in secondary endpoints.
    • “A phase III trial of azetukalner in major depressive disorder is now underway.”
  • The McKinsey Health Institute discusses how “the advent of weight management drugs such as GLP-1s have brought the treatment of obesity to the forefront of public attention, provoking a larger opportunity to work toward metabolic health for all.”

From the U.S. healthcare business front,

  • HHS’s Agency for Healthcare Research and Quality notes,
    • “In 2022, the top 1 percent of people ranked by their healthcare expenditures accounted for 21.7 percent of total healthcare expenditures, while the bottom 50 percent accounted for less than 3 percent.
    • “People with the top 1 percent of expenses had an average of $147,071 in healthcare expenditures in 2022, which was lower than in 2021.
    • “People ages 65 and older and non-Hispanic Whites were disproportionately represented in the above median expenditure tiers.
    • “Ambulatory events, inpatient stays, and prescribed medicines each accounted for about 30 percent of healthcare expenses for people with the top 5 percent of expenses.
    • “Over three-quarters of expenses for people with the top 5 percent of expenses were paid for by private insurance or Medicare.
    • “Among adults in the top 5 percent expenditure tier, 75.1 percent had two or more of the AHRQ-designated priority conditions.”
  • MedCity News tells us,
    • “Most large employers plan to uphold their well-being benefits in 2025 even though they’re facing increasing healthcare costs and global economic headwinds, according to a recent survey from the Business Group on Health.
    • “The Business Group on Health is a nonprofit advocacy organization for large employers. The survey included responses from 131 employers that employ 11.2 million people across the world. Conducted in January and February, it follows another Business Group on Health survey that projected healthcare costs to rise nearly 8% in 2025, the highest increase in over a decade.
    • “The new survey found that 73% of employers plan to maintain their well-being programs in 2025, while 20% will be expanding their programs. The remainder will either decrease their well-being programs or are unsure.” 
  • Fierce Healthcare informs us,
    • “Customer satisfaction with health plans is on the decline, and the gap between the highest and lowest performers is getting wider, according to a new report.
    • “J.D. Power released its annual study looking at consumers’ attitudes toward commercial health plans, which found that the average satisfaction score for this market is 563 on a 1,000-point scale. But there is notable variation in scores based on geography and plan, with a high of 594 and a low of 523.
    • “The J.D. Power report said this means plan members in different parts of the country are having different experiences and finding varied value in their coverage.
    • “Member experience is a critical differentiator for employers and plan sponsors, with 20% of employers saying they switched plans due to low satisfaction among employees. Plans that separate themselves from the pack have invested in engagement, education and service, according to the study.”
  • STAT News lets us know,
    • “A new digital health care marketplace, launched last week, has a good amount of Amazon in its DNA. General Medicine, with $32 million in funding, came out of stealth with three former Amazon employees as co-founders and investors, a business model that could compete with Amazon’s One Medical — and behind the scenes, a current senior Amazon executive. 
    • “The former employees, including the founders of PillPack — the pharmacy company that Amazon bought in 2018 for about $750 million and grew into Amazon Pharmacy — bill General Medicine as a “one-stop shop for expert care” that connects patients to its own telehealth medical practices and to outside care. Sunita Mishra, Amazon Health Services’ chief medical officer, is the physician owner of one of those practices and advised the company early on, General Medicine and Mishra confirmed.”
  • Modern Healthcare reports,
    • “ChristianaCare plans to assume operations of five Crozer Health outpatient facilities in Pennsylvania after submitting the highest bid of $50.3 million. 
    • “The auction was held as Prospect Medical Holdings, Crozer’s parent company, seeks to sell the system’s assets after filing for Chapter 11 bankruptcy protection in January. The sale to Wilmington, Delaware-based ChristianaCare is subject to court approval, according to a Wednesday news release. 
    • “The sale includes two facilities in Glenn Mills, Pennsylvania as well as single facilities in Havertown, Broomall and Media, Pennsylvania. ChristianaCare said it is evaluating the programs and services offered at each location to determine what will be continued, expanded or revamped.”
  • Per Beckers Hospital Review,
    • “Secaucus, N.J.-based Hudson Regional Health, a four-hospital system, has been created as part of the final step in CarePoint Health’s bankruptcy exit.
    • “U.S. Bankruptcy Judge Kate Stickles approved the plan April 17, which went into effect May 22. The system comprises Secaucus-based Hudson Regional Hospital, Jersey City-based Christ Hospital, Hoboken (N.J.) University Medical Center and Bayonne (N.J.) Medical Center, and more than 70 affiliated locations, according to a May 27 Hudson Regional Health news release shared with Becker’s.”
  • “and provides a list of ten new shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.” 

Tuesday Report

David Ermer–CDC, CMS, Congress, COVID-19, Electronic health records, Generative AI, Medical / Rx research, Medicare, Mental health care, Obesity, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC

  • Federal News Network interviews Bloomberg Government deputy news director Loren Duggan about what’s next for the Big Beautiful Bill Act.
  • Per a Senate press release,
    • Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) joined Sens. John Cornyn (R-Texas) and Amy Klobuchar (D-Minn.) to introduce the Don’t Sell My DNA Act to safeguard consumers’ sensitive genetic data during corporate bankruptcy proceedings.
    • The Don’t Sell My DNA Act strengthens consumer privacy protections by:
      • Modernizing the Bankruptcy Code to include genetic information in the definition of “personally identifiable information”;
      • Requiring written notice and affirmative consumer consent prior to the use, sale or lease of genetic information during bankruptcy proceedings; and
      • Requiring the trustee or debtor in possession of genetic information to permanently delete any data not subject to a sale or lease.
    • “Consumers should feel confident that any personal information shared with a public company isn’t up for grabs when that company files for bankruptcy,” Grassley said. “This bill would fill gaps in current law to help safeguard consumers’ genetic information and ensure Americans’ DNA isn’t treated like any other financial asset.”
  • The American Hospital Association lets us know,
    • Department of Health and Human Services Secretary Robert F. Kennedy Jr. May 27 announced in a post on X that the Centers for Disease Control and Prevention would no longer recommend the COVID-19 vaccine for healthy children and pregnant women. 
  • Per Fierce Healthcare,
    • “The Centers for Medicare & Medicaid Services (CMS) Innovation Center announced Monday it is extending three tracks within the Kidney Care Choices (KCC) Model through 2027.
    • “Starting in performance year 2026, the model’s financial methodology and participation options will be modified to “improve model sustainability,” the agency said. However, one KCC Model track will be shuttered a year early at the end of December.
    • “The KCC Model has 93 participants, and implementation first began in January 2022. The most recent participants were announced Jan. 15.”
  • The Equal Employment Opportunity Commission announced last week
    • The EEOC collects workforce data from employers with more than 100 employees (lower thresholds apply to federal contractors). Employers meeting the reporting thresholds have a legal obligation to provide the data; it is not voluntary.  * * *
    • The 2024 EEO-1 Component 1 data collection opened on Tuesday, May 20, 2025. The deadline to file the 2024 EEO-1 Component 1 report is Tuesday, June 24, 2025.
    • “As part of EEOC Acting Chair Lucas’ efforts to identify continued cost savings for the American public, there will be a shorter collection period during which filers may submit their 2024 reports. The collection period will not extend beyond the Tuesday, June 24, 2025 “Published Due Date” deadline. Additionally, beginning with the 2024 EEO-1 Component 1 data collection, all communications sent to filers will be electronic.” * * *
    • “Filers should visit the dedicated EEO-1 Component 1 website at www.eeocdata.org/eeo1
      to access the EEO-1 Component 1 Online Filing System (OFS), to find supplementary resource materials such as the 2024 EEO-1 Component 1 Instruction Booklet and 2024 EEO-1 Component 1 Data File Upload Specifications, and to get the latest updates. Filers needing additional assistance can access the Filer Support Team Message Center upon logging into the OFS.”

In Food and Drug Administration News,

  • The American Hospital Association News tells us,
    • “The Food and Drug Administration has identified a Class I recall of certain lots of BD esophagogastric balloon tamponade tubes due to the potential for serious injury or death. BD said it became aware of some users encountering challenges removing the plastic plugs from the rubber lumen to inflate the balloons. BD and their subsidiary C.R. Bard Urology and Critical Care sent all affected customers a letter with updated use instructions. There have been two serious injuries, and one death associated with the issue.”
  • Per Fierce Pharma,
    • Despite facing ongoing legal pressure from its rival United Therapeutics, Liquidia has successfully landed a pair of long-awaited FDA approvals for its dry powder formulation of treprostinil.
    • The FDA has cleared treprostinil—also known by the trade name Yutrepia—to improve exercise ability in adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
  • and
    • The FDA has also approved Sanofi’s meningococcal vaccine MenQuadfi for use in infants as young as 6 weeks, multiple news outlets reported Tuesday. The shot was already cleared to protect against four prolific strains of meningococcal bacteria in individuals as young as 2 years and older.
    • The FDA based its decision on data from three phase 3 trials that found MenQuadfi worked as well as GSK’s rival meningococcal vaccine Menveo when given with other routine vaccines in children between the ages of 6 weeks to 19 months, Reuters pointed out. Sanofi’s trials enrolled more than 6,000 participants.
  • BioPharma Dive reports,
    • “A patient who received an experimental gene therapy developed by Rocket Pharmaceuticals has died following treatment, the company disclosed Tuesday.
    • “According to Rocket, the patient experienced what’s known as capillary leak syndrome, where plasma and proteins seep from blood vessels into surrounding tissue, and later died from an acute systemic infection.
    • “The Food and Drug Administration ordered the study’s halt Friday, while Rocket works with clinical trial monitors and other experts to investigate the cause. The company said it is focusing on a “novel immune suppression agent” it recently added to a pre-treatment preparatory regimen.”

From the judicial front,

  • The American Medical Association informs us,
    • “In a win for the nation’s youth—and all Americans’ health—the U.S. Supreme Court has ruled (PDF) that the Food and Drug Administration (FDA) did not act in an arbitrary and capricious manner when it told applicants that they could not put certain flavored e-cigarette liquids on the shelf.
    • “The unanimous decision overturned a 5th U.S. Circuit Court of Appeals ruling. Had that appellate-court ruling been allowed to stand, companies could have marketed products that clearly were designed to appeal to children, with names such as “Jimmy the Juice Man Peachy Strawberry,” “Suicide Bunny Mother’s Milk and Cookies,” “Pink Lemonade,” “Iced Pineapple Express” and “Killer Kustard Blueberry.”
    • “Justice Samuel A. Alito Jr., who wrote the opinion for the court, said the FDA did not act arbitrarily and capriciously when it denied the companies’ applications for premarket approval of the tobacco products. The companies challenged the agency’s decision arguing that, among other things, that the FDA didn’t give them fair notice about the evidentiary and comparative requirements used during the application stage and that the agency had changed its position on scientific evidence. 
    • “The high court remanded the case to the 5th Circuit to review other legal arguments, so this is not the end of the litigation, but it is a favorable step forward. The 5th Circuit’s decision was an outlier among the federal circuits that have considered similar cases.”
  • Per Govexec,
    • “At least one agency’s staff impacted by the mass dismissals of probationary workers can pursue their reinstatements as a class, the panel that hears federal employees’ challenges to firings has for the first time ruled, creating a new path for sweeping reversals of those terminations. 
    • “Hundreds of recently hired and subsequently fired employees at the Homeland Security Department will be part of a class action alleging their dismissals were unlawful after a Merit Systems Protection Board administrative judge granted the request. The DHS ruling was the first to come down after a consortium of lawyers filed similar challenges on behalf of fired probationary employees at 20 federal agencies. 
    • “I find that a class appeal is the fairest and most efficient way to adjudicate the appeal and that the putative class counsel and named appellants will adequately represent the interests of the parties,” said Sara Snyder, the chief administrative judge for MSPB’s western regional office.” 

From the public health and medical research front,

  • CBS News reports,
    • Cases of the new COVID-19 variant NB.1.8.1, linked to a large surge in China, have been detected in multiple locations across the United States, according to the Centers for Disease Control and Prevention. The earliest cases in the U.S. date back to late March and early April, and were detected through a screening program at airports for arriving international travelers.
    • “CDC is aware of reported cases of COVID-19 NB.1.8.1 in China and is in regular contact with international partners,” a CDC spokesperson said in a statement last week.
    • The spokesperson said that, so far, too few U.S. sequences have been reported of NB.1.8.1 to be included in the agency’s variant estimates dashboard.
    • But hospitalizations abroad have raised questions about the new variant, its symptoms and more.
    • Answers to those questions may be found in the CBS News article.
  • ABC News adds,
    • “More than five years after the first cases of COVID-19 were detected in the United States, hundreds of people are still dying every week.
    • “Last month, an average of about 350 people died each week from COVID, according to data from the Centers for Disease Control and Prevention (CDC).” * * *
    • “The experts said there are a few reasons why people might still be dying from the virus, including low vaccination uptake, waning immunity and not enough people accessing treatments.” * * *
    • “CDC data shows that those aged 75 and older currently have the highest rate of COVID-19 deaths at 4.66 per 100,000.”
  • The American Medical Association let us know what doctors wish their patients knew about lung cancer screening.
  • The Washington Post relates,
    • “Engagement with digital technology was associated with a 58 percent reduced risk of cognitive impairment in people middle-aged and older, according to a study in the journal Nature Human Behavior.
    • “Researchers conducted a systematic review of 57 studies to see whether exposure to technology has helped or harmed cognition among the first generation of adults with prolonged exposure to digital devices such as smartphones, tablets and computers. The studies involved more than 411,000 adults with an average age of 69.
    • “The analysis revealed that technology could play a role in preserving brain function, not worsening it, said co-authors Jared Benge, a clinical neuropsychologist at the University of Texas at Austin’s Dell Medical School, and Michael Scullin, an associate professor of psychology and neuroscience at Baylor University.”
  • Per Medscape,
    • “Herpes simplex virus 1 (HSV-1) infection is associated with an increased risk of developing Alzheimer’s disease (AD), but treating the viral infection may offer protection, a new study found.
    • “In a matched case-control study of nearly 700,000 older adults, HSV-1 was more common in those with AD, and antiviral therapy for HSV-1 was associated with a lower risk of developing AD.
    • “However, the authors and outside experts cautioned that no firm conclusions can be drawn from this observational study and called for more research.
    • “The study was published online on May 20 in BMJ Open. It was funded by Gilead Sciences, which is actively involved in the research and development of treatments for HSV.”
  • The Wall Street Journal points out,
    • Good posture improves circulation, respiration, digestion and bladder function. It also enhances cognitive ability and mood.
    • To improve posture, become aware of your body position, stand against a wall to align yourself, and perform dynamic stretching exercises.
    • Upright posture is associated with confidence, self-esteem, and reduced anxiety. Physical therapists can help develop personalized plans to improve posture.

From the U.S. healthcare business front,

  • Fair Health released today a claims-based analysis of GLP-1 drugs and obesity. Beckers Hospital Review summarizes this analysis here.
  • The Wall Street Journal considers the price outlook for GLP-1 drugs used to treat obesity.
  • Fierce Pharma tells us,
    • “After a fourth quarter in which revenue boomed throughout the biopharma industry, there were reversals for several drugmakers in the first three months of 2025. 
    • “The companies that took the biggest hits were in the United States, where there is already considerable angst in the industry over the tariff threats and drug price-slashing aspirations of President Donald Trump, along with the unsettling prospects of having a pharma adversary, Robert F. Kennedy Jr., heading up the Department of Health and Human Services.
    • “Among the top 25 revenue companies in the industry in Q1, there were seven that saw year-over-year sales declines, all from the U.S. Viatris took the biggest hit at 11%, followed by Pfizer (-8%), Organon (-7%), Bristol Myers Squibb (-6%), Regeneron (-4%), Merck (-2%) and Gilead (-0.3%).”
  • Per BioPharma Dive,
    • “Eli Lilly is wagering up to $1 billion on a private biotechnology company developing new, non-opioid pain drugs that have already caught the attention of other large pharmaceutical firms.
    • “Per an announcement Tuesday, Lilly plans to acquire SiteOne Therapeutics in an all-cash deal. The companies aren’t disclosing how much money is being exchanged upfront or when they expect the transaction to close. But, if SiteOne’s research programs hit certain regulatory and commercial goals, the amount paid to its shareholders could reach that 10-figure mark.”
  • and
    • “Biogen is partnering with RNA drug developer City Therapeutics to develop a better way of reaching an unspecified target that “mediates key central nervous system diseases.” Biogen will pay City, a startup that launched publicly late last year, $16 million in upfront fees and invest another $30 million in convertible notes that could later become a minority stake. “With this effort, we are further expanding the modalities in our R&D toolbox to potentially reach our targets of interest more precisely by adding an RNAi-based approach,” Biogen research head Jane Grogan said in a statement.”
  • Per an Institute for Clinical and Economic Review news release,
    • “ICER today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of apitegromab(Scholar Rock Holdings), nusinersen (Spinraza®, Biogen), onasemnogene abeparvovec-xioi (Zolgensma®, Novartis), and risdiplam (Evrysdi®, Genentech) for spinal muscular atrophy (SMA).
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.”
  • Beckers Health IT discusses why Texas Health is taking a loss on its hospital at home program and summarizes Medscape’s list of telehealth friendly states which Utah leads.
  • Beckers Clinical Leadership identifies the 24 U.S. hospitals that have received the American Nurses Credentialling Center’s Magnet with Distinction award. “The Magnet with Distinction program was created as a special designation to celebrate hospitals and healthcare organizations that exceed scoring thresholds required to earn Magnet recognition.”
  • The Wall Street Journal reports,
    • “AI-powered ambient-listening technology is expanding in healthcare, documenting doctor-patient encounters.
    • “AI scribes save doctors time on documentation, reducing burnout and improving focus on patients, according to pilot programs.
    • “Concerns exist around patient privacy, data security and costs, but patient feedback has been largely positive.”
  • Fierce Healthcare offers insights into how Anthem Blue Cross is growing its behavioral health network in California.
    • “The insurer’s network is built on partnerships with multiple organizations, with recent additions including Headway, Rula and Octave. Through its relationship with these firms, the insurer is seeking to make it simpler for members to find providers that meet their unique needs.
    • “Through Headway, the insurer connects employers and plan members with personalized services. Rula, meanwhile, makes it easier for members to schedule an appointment with one of the more than 10,000 providers in its network.
    • “Octave, similarly, is built to make it simple for members to find a provider across multiple specialties, backgrounds and evidence-based approaches, according to the announcement.”
  • NIST explains for those interested how an MRI machine works.

Friday Report

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, NCQA, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Federal News Network tells us,
    • “The Office of Personnel Management is taking a second bite at the apple to modernize its human resources platform.
    • “OPM released a new request for proposals on Thursday through the General Services Administration schedules program for a secure, cloud-based software-as-a-service (SaaS) human capital management (HCM) platform.
    • “The objective of this acquisition is to deploy an integrated, enterprise-wide core HR platform—powered by a secure, FedRAMP-authorized SaaS solution—that consolidates key human capital functions, including personnel management, time and attendance, leave, benefits administration, learning and performance management and workforce analytics,” the RFP states. “The platform must enable seamless interoperability with critical external systems (e.g., USA Staffing, GSA Payroll, eOPF, eHRI, LMS, and benefits systems) and eliminate the data and process gaps currently affecting onboarding, pay accuracy, personnel action sequencing, leave eligibility and audit reporting.”
    • “The solicitation says the platform will be used for OPM’s workforce of 2,000 to 3,000 people.”
  • Fierce Healthcare informs us,
    • “The Centers for Medicare & Medicaid Services (CMS) revealed several updates to the ACO REACH program in 2026, though the model’s long-term future remains unclear.
    • “The CMS said it is making changes to the model based on preliminary data on 2023 performance (PDF), which found that standard accountable care organizations saved $197.5 million in aggregate that year. New entrant ACOs, meanwhile, generated $36.8 million in aggregate savings, reducing gross spending at higher rates that standard organizations.
    • “In addition, high-needs ACOs reduced spending by $2.3 million in the aggregate, according to the preliminary report. The CMS is set to release full data on ACO REACH later this year.
    • “The proposed changes come in a confusing environment for ACOs, which have pushed the agency to outline plans for the ACO REACH program, currently set to expire in 2026.”
  • The American Hospital Association News let us know,
    • “AHA May 23 submitted recommendations to the Department of Justice and Federal Trade Commission in response to the agencies’ requests for information on unnecessary or burdensome anticompetitive regulations. “[T]he U.S. health care system imposes a bewildering array of regulations on hospitals and health systems, adding significant administrative costs, disincentivizing pro-competitive arrangements, and promoting vertical consolidation of large commercial insurers to the detriment of patients and providers across the country,” AHA Deputy General Counsel Julie Rapoport Schenker wrote in the letters to the agencies. The AHA’s recommendations included addressing regulations that foster anticompetitive conduct by insurers and limit the ability of hospitals and health systems to thrive in a competitive free market, among others.” 

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP points out,
    • “Excess deaths in the United States kept rising even after the peak of the COVID-19 pandemic, with more than 1.5 million in 2022 and 2023 that would have been prevented had US death rates matched those of peer countries, estimates a Boston University (BU)-led study today in JAMA Health Forum.
    • “The data show a continuation of a decades-old trend toward increasing US excess deaths, mainly among working-age adults, largely driven by drug overdoses, gun violence, auto accidents, and preventable cardiometabolic causes, the researchers say.
    • “The US has been in a protracted health crisis for decades, with health outcomes far worse than other high-income countries,” says lead and corresponding author Jacob Bor, ScD, said in a BU news release. “This longer-run tragedy continued to unfold in the shadows of the COVID-19 pandemic.”
  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza, COVID-19, and RSV activity is low.
    • “COVID-19
      • “COVID-19 activity has declined to low levels nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home.
    • “Influenza
    • “RSV
      • “RSV activity has declined to low levels in most areas of the country.”
  • The New York Times reports,
    • “Cancer screening poses a quandary for women with dense breast tissue. They’re at elevated risk for breast cancer, but mammograms often miss tumors buried in dense breasts — and insurers often resist paying for additional scans that may help find the masses.
    • “Now a large study comparing various types of scans has found that mammography enhanced with iodine-based dye can detect three times as many invasive cancers in dense breast tissue as ultrasound.
    • “And so-called contrast-enhanced mammography can find tumors that are much smaller than those found by regular mammography. M.R.I.s are better at detecting more tumors than standard mammograms, the study found but are considerably more expensive.
    • “The scans were given to women with dense breast tissue who had already undergone mammograms that hadn’t turned up any abnormalities.”
    • “Contrast-enhanced mammography needs to become standard of care for women with dense breasts,” if they are at high risk of developing breast cancer, said Dr. Fiona J. Gilbert, a professor of radiology at the University of Cambridge’s School of Clinical Medicine. She is lead author of the study, which was published Wednesday in The Lancet.”
  • NCQA offers via LinkedIn a White Paper, Webinar and a New HEDIS Measure for Asthma Awareness Month, which is May.
    • “The HEDIS MY 2026 measure set will include a new measure focused on asthma, Follow-Up After Acute Care Visits for Asthma (AAF-E). Patients with uncontrolled asthma are more likely to seek care for acute exacerbations, rather than focusing on preventive care. The new measure focuses on the patient-clinician relationship as encouraging treatment adherence and efficacy. Guiding patients toward non-acute care—and clinicians with whom they have a trusted relationship—may help improve asthma outcomes.”
  • The Wall Street Journal delves into “new tests [that] promise to reveal the secrets in your blood. A wave of diagnostic tests—some here, some coming—can identify cancer and Alzheimer’s at earlier stages and predict flare-ups of other conditions.”
  • Per HCPLive,
    • “Semaglutide demonstrated notable protective effects on osteoporosis and gout in people with obesity and type 2 diabetes (T2D) in a new cohort study.
    • “The impact of newer anti-obesity medications on skeletal health remains incompletely understood, particularly in populations with varying metabolic profiles,” lead investigator Jo-Ching Chen, Chung Shan Medical University Hospital, Taichung, Taiwan, and colleagues wrote.
    • “Chen and colleagues conducted a 5-year cohort study examining skeletal health outcomes in people with obesity and T2D receiving semaglutide vs conventional glucose-lowering medications (sitagliptin, empagliflozin, glipizide), and obese individuals without T2D receiving semaglutide vs traditional anti-obesity medications (Contrave, phentermine, Qsymia).”
  • Per Fierce Pharma,
    • “After meeting the mark alongside Keytruda in PD-L1-positive breast cancer earlier this year, Gilead Sciences’ antibody-drug conjugate Trodelvy has impressed in a solo showing in a similar indication.
    • “In the late-stage Ascent-03 trial, Trodelvy bested standard-of-care chemotherapy at extending the time before disease worsening or death in certain patients with previously untreated metastatic triple-negative breast cancer (TNBC).
    • “The study specifically assessed the TROP2-targeted ADC in patients who aren’t candidates for PD-1 or PD-L1 inhibitors, either because their tumors don’t express the PD-L1 protein or because the patients are ineligible.
    • “The “highly statistically significant and clinically meaningful” improvement on the progression-free survival metric allowed the study to meet its primary endpoint, Gilead said. The company will discuss the Ascent-03 results with regulators and plans to present detailed results from the trial at an upcoming medical meeting.”

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • “The nation’s leading nonprofit healthcare providers struggled financially during the quarter ended March 31.
    • “Most of the major systems, including Kaiser Permanente, Mass General Brigham, Cleveland Clinic, Mayo Clinic, Ascension and Providence, recorded operating margins that were flat or lower than this time last year, despite growing patient volumes.
    • “The results come as analysts have been sounding the alarm with escalating urgency about how headwinds, including market volatility and policy changes in Washington, could harm provider finances.” 
  • Beckers Health IT explains “two ways Amazon is changing healthcare, per CEO Andy Jassy.”
  • Per Health Leaders,
    • “A recent Experian Health survey shows steady improvement in access to care but suggests a disconnect between patients and providers on digital tools.
    • “Providers continue to face challenges with capacity constraints and staffing shortages.
    • “Patients call for better pricing estimates and self-scheduling tools.”
  • Healthcare Innovation lets us know,
    • Aligning itself with new strategies coming out of the Center for Medicare and Medicaid Innovation, the Health Care Payment Learning & Action Network (HCPLAN) announced it will launch four new initiatives focused on healthcare choice and competition, patient empowerment, preventative care, and technology-enabled healthcare, while discontinuing its alternative payment model measurement effort, which had been funded by CMMI.
    • The HCPLAN is a group of public and private healthcare leaders that was formed to provide thought leadership, strategic direction, and ongoing support to accelerate the adoption of alternative payment models (APMs) and accountable care.
    • Since its launch in 2015, the HCPLAN APM Measurement Effort has monitored the shift of U.S. healthcare from fee-for-service to APMs. The 2024 APM Measurement Effort results demonstrated the continued growth in APM adoption and initiatives to enhance patient access, affordability, and quality of care. As part of its efforts to advance the availability and reduce the cost of key data needed to improve care, the HCPLAN will explore alternative pathways for the continuation of this effort.
  • MedTech Dive explores “Why Medtronic plans to spin out its diabetes business. While some analysts questioned why Medtronic would leave a fast-growing market, others backed the company’s plan to focus on segments with higher margins.”
  • Per Fierce Healthcare,
    • “Pharmacy benefit manager WellDyne is partnering with Waltz Health to bring greater transparency to its specialty pharmacy clients.
    • “WellDyne is teaming up with Waltz as well as Mark Cuban Cost Plus Drugs as part of its broader member routing strategy, which surfaces real-time alerts and smart prompts that can help its members find the most affordable medication option for them.
    • “The PBM’s tech stack also uses automated algorithms to adjudicate claims in the background and let members know when they may be able to achieve savings. The technology optimizes claims across different touch points including retail, home delivery, discount cards and other avenues.
    • “Rich Wipperfurth, chief commercial officer for WellDyne, said traditional models are also built on simplicity but in a way that steers the member toward preferred distribution channels, pharmacies and other sources.
    • “WellDyne wants to inject more choice back into the equation, Wipperfurth said.”

Thursday Report

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • President Trump’s “big, beautiful bill” squeezed through the House after a late scramble to get rival factions on board. Next it goes to the Senate, where GOP lawmakers are already making demands and party leaders will once again need to bridge sharp disagreements.
    • The more than 1,000-page bill passed the House early Thursday morning after Speaker Mike Johnson (R., La.) found a recipe that satisfied just enough lawmakers, who approved the measure by just one vote after an all-night session. Now Senate Republican leader John Thune (R., S.D.) needs to line up enough support within his own narrow majority—without making changes that fracture the fragile House agreement and derail the party’s hopes to finish the bill by its July 4 target.
  • Federal News Network explains,
    • “Four of the six provisions on federal benefits cuts that originated from Republicans on the House Oversight and Government Reform Committee remain in the House-passed version of the bill, which now heads to the Senate for consideration. But notably, the proposed change to a “high-5” annuity calculation is no longer on the table. The provision was struck from the reconciliation legislation prior to the House’s passage of the bill.
    • “Oversight committee Democrats, as well as Rep. Mike Turner (R-Ohio), led efforts to remove the “high-5” proposal from the reconciliation bill. Rep. Stephen Lynch (D-Mass.) proposed an amendment to strike the “high-5” provision, which was ultimately adopted.
  • Tammy Flanagan, writing in Govexec, answers frequently asked questions about federal retirement.
  • The American Hospital Association (AHA) News tells us,
    • “Food and Drug Administration Commissioner Marty Makary testified May 22 before the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies on the discretionary budget proposal for fiscal year 2026. The proposal includes $93.8 billion for the Department of Health and Human Services, which oversees the FDA. The allocation is a 26.2% reduction from the FY 2025 enacted level.”  
  • The House of Representatives and the Senate left Washington DC today for a weeklong District/State work break following Memorial Day next Monday. The Senate Majority Leader announced his plans to file additional cloture motions for Presidential nominees when the Senate returns to Capitol Hill on June 2. That list does not include the President nominee for OPM Director Scott Kupor.
  • The AHA News informs us,
    • “The White House May 22 released its Make America Healthy Again report that focuses on childhood chronic disease. The report highlights findings from the MAHA Commission related to poor diet, exposure to environmental chemicals, lack of physical activity, stress and overmedicalization. The report lists a series of recommendations and next steps for research, including studies on nutrition, lifestyle interventions and precision toxicology. In parallel, the commission will develop a strategy to be released in August.”
  • The Washington Post assesses the report here.
  • The AHA News adds,
    • “The Departments of Labor, Health and Human Services, and the Treasury May 22 released several new guidance documents and requests for information on price transparency, following the February executive orderon the same subject. As part of this package, CMS released new guidance on calculating the estimated allowed amount values in the hospital machine-readable files. Whenever possible, hospitals should use the average dollar amount received over the last 12-month period (or less, if the payment methodology was only used for part of the year), which should be derived from the electronic remittance data. If there is no historic data, hospitals should use the expected payment amount, encoded as a dollar figure. This replaces previous guidance which allowed hospitals to use a code of nine number nines to signify that there was not sufficient historic data for that item or service over the last year. CMS also released an RFI on hospital price transparency accuracy and completeness. Comments are due July 21. The AHA plans to submit comments.  
    • “The departments also released a FAQ document, announcing that a new standard format for the insurer machine-readable files will be released Oct. 1, 2025. The new format aims to reduce the file size of the insurer files by decreasing duplicative data. In addition, the departments issued an RFI on improving prescription drug price transparency as part of the Transparency in Coverage, or insurer transparency rule.”

From the Food and Drug Administration front,

  • Per BioPharma Dive,
    • “Advisers to the Food and Drug Administration have recommended COVID-19 vaccine makers continue to target their shots to the so-called JN.1 coronavirus strain for the upcoming fall and winter seasons, maintaining guidance they gave last year.
    • The advisory committee convened Thursday for the first time under the Trump administration, meeting two days after FDA leadership unveiled new guidelines for COVID vaccine approvals. All nine members of the panel voted in favor of targeting shots to the JN.1 family of variants.
    • The FDA doesn’t have to follow the panel’s advice but usually does.”
  • STAT News adds,
    • “In another sign of growing scrutiny over Covid-19 vaccines, the Food and Drug Administration has asked the two makers of mRNA vaccines to widen the age range of boys and young men that their labels say are at risk for a rare side effect causing heart inflammation.
    • “The letters, first reported by CBS News, asked Moderna and partners Pfizer and BioNTech to make updates to safety information based on new studies of myocarditis or pericarditis or both after vaccination. Both reactions are rare and known to occur most often in young men within a week after the second shot in the two-dose Covid-19 vaccine regimen, according to the Centers for Disease Control and Prevention. Most cases were mild, causing no more than brief chest pain.”
  • Per MedTech Dive,
    • “Stryker has received 510(k) clearance for a minimally invasive back pain treatment, positioning it to challenge Boston Scientific for the market. 
    • “The Food and Drug Administration clearance, which Stryker disclosed Monday, covers the use of the OptaBlate basivertebral nerve ablation system to provide relief for low back pain.
    • “Stryker is entering a growing market. Boston Scientific’s rival device, which it acquired for $850 million upfront in 2023, “grew strong double digits” in the first quarter, CEO Mike Mahoney told investors in an April earnings call.”
  • Per Fierce Pharma,
    • “While GSK’s Nucala may not have earned the distinction of becoming the first FDA approved biologic for chronic obstructive pulmonary disease (COPD), the British drugmaker is confident its IL-5 antibody still has a major role to play in tackling the traditionally tough-to-treat respiratory condition.
    • “Now, following an unexpected delay earlier this month, the company has a fresh FDA green light to put its thesis to the test.
    • “The FDA on Thursday approved Nucala as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype.” 
  • and
    • “In a somber end to an FDA advisory committee’s two-day scouring of multiple drugmakers’ oncology data, Pfizer’s pitch to expand Talzenna into a broader prostate cancer population has failed to impress.
    • “Late Wednesday, eight outside experts on the FDA’s Oncologic Drugs Advisory Committee delivered a unanimous 8-to-0 ‘No’ vote on the question of whether Pfizer’s PARP inhibitor Talzenna has a favorable benefit-risk profile in metastatic castration-resistant prostate cancer (mCRPC) patients without homologous recombination repair (HRR) gene mutations.
    • “Patients without HRR mutations make up the majority of the mCRPC patient population at about 70%, according to briefing docs released ahead of the meeting.”

From the judicial front,

  • Healthcare Dive tells us,
    • “A bankruptcy judge on Wednesday approved Rite Aid’s pharmacy asset sales to a variety of buyers, including some of the bankrupt drugstore chain’s rivals.
    • “Financial details were not disclosed, and sale documents redacted purchase prices for Rite Aid’s assets, which went to retail pharmacy chains like CVS and Walgreens, along with grocers Albertsons, Kroger and Giant Eagle and other buyers.” * * *
    • “The liquidation is a growth opportunity for CVS, already the nation’s largest drugstore chain with more than 9,000 pharmacies. The Woonsocket, Rhode Island-based company purchased prescription files from 625 Rite Aid stores in 15 states and fully acquired 64 brick-and-mortar Rite Aid locations in Idaho, Oregon and Washington.”
  • The Associated Press reports,
    • “The Supreme Court’s conservative majority on Thursday declined to reinstate independent agency board members fired by President Donald Trump, endorsing a robust view of presidential power.” * * *
    • “The court’s action essentially extended an order Chief Justice John Roberts issued in April that had the effect of removing two board members who Trump fired from agencies that deal with labor issues, including one with a key role for federal workers as Trump aims to drastically downsize the workforce.
    • “Neither agency has enough appointed members to take final actions on issues before them, as Trump has not sought to appoint replacements.”
    • “The decision Thursday keeps on hold an appellate ruling that had temporarily reinstated Gwynne Wilcox to the National Labor Relations Board and Cathy Harris to the Merit Systems Protection Board.”
  • Bloomberg Law points out,
    • “A federal district court judge in California said she will likely extend a freeze on President Donald Trump’s plan to lay off thousands of federal workers, dealing another blow to his unprecedented overhaul of the federal workforce. 
    • “Judge Susan Illston of the US District Court for the Northern District of California at a Thursday hearing said she is inclined to grant a preliminary injunction halting the layoffs while the case proceeds, temporarily protecting the jobs of thousands of federal workers.” 

From the public health and medical research front,

  • NBC News reports,
    • “New data from Truveta, a health care and analytics company, shows that the percentage of 6-month-old babies in Texas getting their measles vaccination in April increased by more than 30 times the prior year’s average.
    • “That means parents aren’t just getting the vaccine early, they’re getting it as early as they can,” Nina Masters, a senior scientist at Truveta and part of the research team, said in an interview with NBC News.
    • “Typically, the MMR is given in two doses, around a child’s first birthday, and again around the time a child enters kindergarten, at age 4 or 5. One dose is 93% effective at preventing measles, according to the Centers for Disease Control and Prevention. A second dose increases protection to 97%.”
  • Per Fierce Pharma,
    • “Roche, hoping to carve out a standard-of-care spot for its PI3K inhibitor Itovebi, now has another leg to stand on with new evidence that shows the drug can extend the lives of certain patients with breast cancer.
    • “Adding Itovebi to Ibrance and Faslodex slashed the risk of death by 33% in patients with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer that has grown during or after hormone therapy treatment. The data, to be presented at the American Society of Clinical Oncology’s (ASCO’s) annual meeting, come from Roche’s pivotal phase 3 INAVO120 trial. 
    • “In the 325-patient study, Roche’s Itovebi triplet combination kept patients alive for a median of 34 months compared to 27 months for those who took a placebo along with Ibrance and Faslodex.”
  • and
    • “Roche’s plan to bolster Tecentriq’s position in small cell lung cancer with Jazz Pharmaceuticals’ Zepzelca has paid off. But the pair’s success leaves room for improvement for future contenders.
    • “Adding Zepzelca on top of Tecentriq as maintenance treatment of first-line extensive-stage small cell lung cancer (ES-SCLC) significantly reduced patients’ risk of death by 27% compared with Tecentriq alone, according to data from the phase 3 IMforte trial.
    • “Patients who received the combo lived a median 13.2 months, versus 10.6 for those who got Tecentriq alone. The results will be presented at the 2025 American Society of Clinical Oncology annual meeting.”
  • STAT News relates,
    • “Merus said Thursday that a combination of its experimental drug petosemtamab with the checkpoint inhibitor Keytruda has kept 79% of patients with newly diagnosed metastatic head and cancer alive for at least one year, according to a new analysis of a mid-stage clinical trial. 
    • “The survival data are only a snapshot. Merus, a Dutch biotech, will need to complete a larger, randomized study to prove more definitively that its drug can extend the lives of patients with head and neck cancer beyond the ability of current treatments. But for now, the preliminary survival results are encouraging and matched the expectations of investors.
    • “Merus released the new petosemtamab data ahead of a presentation next week at the annual meeting of the American Society of Clinical Oncology.”
  • Per BioPharma Dive, “AI tool could help doctors ID breast cancers vulnerable to Enhertu. Tumors with low- and ultra-low levels of a protein called HER2 are treatable with Enhertu, but harder to identify. New research shows AI can improve diagnosis.”
  • Per a National Institutes of Health news release,
    • “National Institutes of Health (NIH) scientists have developed a new surgical technique for implanting multiple tissue grafts in the eye’s retina. The findings in animals may help advance treatment options for dry age-related macular degeneration (AMD), which is a leading cause of vision loss among older Americans. A report about the technique published today in JCI Insight.
    • “In diseases such as AMD, the light-sensitive retina tissue at the back of the eye degenerates. Scientists are testing therapies for restoring damaged retinas with grafts of tissue grown in the lab from patient-derived stem cells. Until now, surgeons have only been able to place one graft in the retina, limiting the area that can be treated in patients, and as well as the ability to conduct side-by-side comparisons in animal models. Such comparisons are crucial for confirming that the tissue grafts are integrating with the retina and the underlying blood supply from a network of tiny blood vessels known as the choriocapillaris.
    • “For the technique, investigators designed a new surgical clamp that maintains eye pressure during the insertion of two tissue patches in immediate succession while minimizing damage to the surrounding tissue.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health insurance companies initially declined to pay more than one dollar for every $10 providers submitted in claims last year, an increase from 2023.
    • “Payers in 2024 initially denied 11.8% of dollars associated with hospital-based claims, according to a report from consultant Kodiak Solutions. That compares with 11.53% of dollars denied in 2023.
    • “The company examined data from its revenue cycle analytics platform used by more than 2,100 hospitals and 300,000 physicians. It categorized any initial bill that commercial, Medicaid and Medicare insurers initially rejected, or requested more information for, as a denial.
    • “Insurers often overturned their initial denials and ended up paying nearly 97% of dollars requested, according to the report.”
  • Reuters informs us,
    • “Median annual list price for new drugs over $370,000 in 2024
    • “72% of new drugs in 2024 for orphan diseases
    • “Drugmakers emphasize value, offer savings programs amid rising list prices.”
  • The International Foundation for Employee Benefit Plans shares its survey of GLP-1 drug coverage and expenses among employer sponsored plans.
  • Fierce Pharma notes,
    • “It’s plainly apparent that Novo Nordisk has had May 22 circled its calendar since February, when the FDA began the countdown for compounders to stop selling their versions of semaglutide.
    • “Now that the day has come, the Danish drugmaker is capitalizing on the chance to steer more patients toward its branded offerings.
    • “Self-paying patients new to Wegovy can access a one-month supply of the obesity blockbuster for $199 through June 30, Novo announced on Thursday. After that, the drug will go for its standing price of $499 a month for cash-paying customers, which was discounted in March from a previous price tag of $650 per month.”
  • Fierce Healthcare relates,
    • “Shares of Hinge Health jumped 22% above the initial public offering price in the company’s New York Stock Exchange debut on Thursday, bringing its market capitalization to more than $3 billion.
    • “The physical therapy company’s stock opened at $39.25 on Thursday and closed at $37.56, up 17% from its $32 per share IPO price. Hinge Health’s IPO has been closely watched given the recent stagnation in the exit markets and signals a potential upswing in the public investor market.”
  • Becker Hospital Review announced,
    • “Northern Light Inland Hospital and its associated clinical services in Waterville, Maine, will officially close May 27, marking the end of operations for the facility that has been gradually winding down since the closure was announced earlier this year.
    • “The hospital’s emergency department will stop accepting new patients at 12 p.m. on May 27. All remaining clinical services will cease at 5 p.m. the same day, the health system said in a May 22 news release.”

Tuesday Report

David Ermer–CDC, Congress, COVID treatment, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC,

  • Following up on yesterday’s post about the House budget reconciliation bill, Govexec informs us,
    • “According to the latest draft of the bill, published early Monday morning, Republicans have ditched the plan to effectively un-grandfather employees hired prior to 2014 into paying more of their paychecks toward their retirement benefits.
    • “On the FERS supplement, which can amount to one-third of a federal retiree’s income until they turn 62, lawmakers expanded an exemption for federal workers who are required to retire early, such as air traffic controllers and federal law enforcement personnel, to cover all such employees, regardless of whether they actually are forced out because they hit the mandatory retirement age. The implementation date, previously set on the date of the bill’s enactment, has been shifted to Jan. 1, 2028, and language now exists clarifying that federal employees may maintain eligibility for the supplement provided they are “entitled” to it prior to 2028.
    • “The latest draft also delays the change in federal retirees’ annuity calculations from the high-3 to high-5 average salary model by one year, to Jan. 1, 2028.”
  • KFF posted a summary of Medicaid provisions in the House budget reconciliation bill.
  • Roll Call reports,
    • “President Donald Trump urged the House GOP to stop negotiating and pass his “big, beautiful” filibuster-proof reconciliation bill Tuesday, with sharp words for blue-state Republicans pushing for more tax relief and conservatives seeking additional spending cuts.
    • “In an appearance during the weekly GOP conference meeting, Trump told conservatives to lay off Medicaid, scolded blue-state Republicans for rejecting a $30,000 cap on state and local tax deductions and urged the party to increase the country’s borrowing limit through the rest of his term, members leaving the meeting said. * * *
    • “Trump’s visit did little to move the needle in support of the bill, leaving leadership where they started the week: trying to strike a balance between steeper cuts needed to satisfy conservatives without alienating centrists, and finding space for more SALT relief.
    • “Republicans can afford to lose no more than three GOP votes and pass the partisan legislation.
    • “After the meeting, Speaker Mike Johnson said he was ready to convene the holdouts in smaller groups to try to reach a deal.”
  • Per a Congressional press release,
    • “Congressman Gerald E. Connolly (D-VA) and Congressman James Comer (R-KY), the Ranking Member and Chairman of the House Committee on Oversight and Government Reform respectively, introduced the Esophageal Cancer Awareness Act, bipartisan legislation to commission a Government Accountability Office (GAO) study on gaps in screening and prevention of esophageal cancer. 
    • “Esophageal Cancer is quickly on the rise, touching the lives of tens of thousands of Americans – including mine,” said Ranking Member Connolly. “It is vital that we all do our part to raise awareness and push for more research and more effective prevention efforts. I am immensely grateful to my colleague, Chairman Comer, for joining me in introducing this important legislation today. Together, we will fight to end esophageal cancer, bringing hope to thousands of American families.” * * *
    • “Text of the legislation is available here.”
  • The American Hospital Association News tells us,
    • Secretary of Health and Human Services Robert F. Kennedy Jr. May 20 appeared before the Senate Appropriations Committee for a hearing to testify on the discretionary budget proposal for fiscal year 2026.
      • Roll Call offers more details on the hearing.
  • and
    • “The Department of Health and Human Services May 20 announced it has identified specific pricing targets for pharmaceutical manufacturers to meet to satisfy requirements of the Trump administration’s executive order allowing consumers to make direct purchases from drug manufacturers at “most favored nation” pricing, the lowest cost paid for the same medications in an Organization for Economic Co-operation and Development country with a gross domestic product per capita that is at least 60% of the U.S. GDP per capita.”
      • Beckers Hospital Review calls attention to six things to know about this announcement.

From the Foord and Drug Administration front,

  • The Wall Street Journal points out,
    • “The Trump administration released a more stringent set of guidelines for approving Covid-19 vaccines, requiring more evidence for new shots for healthy adults and children.
    • “Any new Covid vaccines for many children and adults will be required to undergo randomized, controlled trials before receiving Food and Drug Administration approval, FDA Commissioner Dr. Marty Makary and the agency’s new vaccines chief, Dr. Vinay Prasad, wrote Tuesday in the New England Journal of Medicine. The agency expects that it will be able to approve the shots for adults older than 64 and high-risk groups based on antibody testing but will encourage drugmakers to conduct more randomized trials for those shots too.”
  • MedPage Today notes,
    • The FDA warned that some people develop severe itching, or pruritus, after stopping long-term use of the antihistamines cetirizine (Zyrtec) or levocetirizine (Xyzal).
    • Prescribing information for the oral allergy drugs — which are taken daily and sold both in prescription and over-the-counter (OTC) forms — will be updated to warn about the post-discontinuation risk. The itching typically occurs within a few days of stopping the products.
    • “Restarting the medicine resolved pruritus in most individuals, and tapering off the medicine after restarting it resolved symptoms in some who tried this approach,” the FDA said in its safety communication.”
  • Fierce Pharma adds,
    • “Roche looks unlikely to be able to move its DLBCL drug Columvi earlier in the treatment sequence after experts in an FDA advisory committee joined the agency in questioning the regional imbalance of clinical trial data. What’s more, both FDA Commissioner Martin Makary, M.D., and longtime FDA oncology chief Richard Pazdur, M.D., have a new message for drug developers.
    • “A panel of experts on the FDA’s Oncologic Drugs Advisory Committee voted 8 to 1 Tuesday that results from Roche’s phase 3 Starglo trial are not applicable to a U.S. patient population. The trial evaluated the combination of Columvi and the chemotherapy regimen GemOx in second- or later-line transplant-ineligible DLBCL. 
    • “A patient representative cast the only yes vote.”
  • MedTech Dive announced the creation of an online database that tracks FDA approval of medical devices that incorporate artificial intelligence.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The Covid-19 virus in the U.S. has largely faded from view. But it hasn’t faded away. 
    • “National wastewater data shows low Covid-19 activity, according to the Centers for Disease Control and Prevention. The weekly reported Covid-19 deaths in April were slightly down compared with the same time a year earlier, federal data shows. Still, more than 300 Covid-19-related deaths were reported weekly as recently as mid-April. 
    • “Some infectious-disease specialists said they expect more cases this summer, as there have been somewhat regular summertime increases in the past. Others cautioned that Covid-19 can still surprise us, more than five years after it spurred a global pandemic that killed more than 1.2 million Americans. 
    • “It is at our lowest levels it has been since the beginning of the pandemic,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “Our challenge is we don’t know what that means for tomorrow.” 
  • Per MedPage Today,
    • “The use of antibiotics in patients hospitalized with non-severe COVID-19 was not associated with better outcomes, a large retrospective cohort study found.
    • “Among more than half a million U.S. patients with COVID, those given antibiotics on their first day of hospitalization had a slightly higher rate of deterioration or death compared with those who didn’t receive antibiotics (20.8% vs 18.4%), reported researchers led by Michael Pulia, MD, PhD, of the University of Wisconsin-Madison.
    • “The difference didn’t meet criteria for being of clinical significance. However, a propensity-matched analysis did show a significantly higher odds of poor clinical outcomes for those who received antibiotics (OR 1.03, 95% CI 1.01-1.05, P=0.003), according to findings published in JAMA Network Open.
    • “Hopefully, studies like this raise the bar for antibiotic initiation in patients with confirmed COVID-19, even if they are sick enough to require hospital admission,” Pulia told MedPage Today.
    • “Pulia noted that there’s often a lot of uncertainty as to whether a patient hospitalized with COVID also has a bacterial infection, so physicians may prescribe antibiotics to be safe. “Hopefully, studies like this will reduce this uncertainty and improve judicious antibiotic use, thus helping in the fight against antibiotic resistance,” he said.”
  • The New York Times discusses “A New System Aims to Save Injured Brains and Lives. Nearly 100 neurology experts collaborated on the creation of a new method of evaluating patients with traumatic brain injuries.”
  • The latest National Institutes of Health’s (NIH) Research Matters covers “Cancer trends in younger people | Measuring biological age | Brain rewiring in motor learning.”
  • Per a NIH news release,
    • For the first time, researchers at the National Institutes of Health (NIH) identified patterns of metabolites in blood and urine that can be used as an objective measure of an individual’s consumption of energy from ultra-processed foods. Metabolites are left after the body converts food into energy, a process known as metabolism. Scientists used these data to develop a score based on multiple metabolites, known as a poly-metabolite score, that has the potential to reduce the reliance on, or complement the use of, self-reported dietary data in large population studies. The findings appeared May 20, 2025, in PLOS Medicine.   
    • “Limitations of self-reported diet are well known. Metabolomics provides an exciting opportunity to not only improve our methods for objectively measuring complex exposures like diet and intake of ultra-processed foods, but also to understand the mechanisms by which diet might be impacting health,” said lead investigator Erikka Loftfield, Ph.D., M.P.H., of NIH’s National Cancer Institute.”
  • MedPage points out,
    • “Dementia incidence fell among Medicare beneficiaries from 2015 to 2021, but prevalence rose.
    • “Incidence was higher for Black beneficiaries than any other racial or ethnic group.
    • “Those living in socioeconomically deprived neighborhoods had the highest incidence and prevalence.”
  • FYI, “Prevalence differs from incidence in that prevalence includes all cases, both new and preexisting, in the population at the specified time, whereas incidence is limited to new cases only.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
  • STAT News lets us know,
    • “Developers of digital mental health treatments now have fresh economic data to help make the case for broader coverage of their apps.
    • “Companies selling Food and Drug Administration-cleared apps for the treatment of psychiatric and other conditions have long struggled with adoption by patients, providers, and payers for many reasons. Clinical evidence supporting these prescription digital therapeutics has gradually improved, but policymakers and insurers have been hesitant to open the path to reimbursement too quickly.” * * *
    • “In a new report, the Peterson Health Technology Institute (PHTI) finds that Rejoyn, an app for depression from Otsuka Precision Health, and DaylightRx, an app for anxiety from Big Health, warrant further adoption because their clinical trials show strong evidence of benefits. Both apps are intended to be used alongside ongoing mental health treatment, and in most cases, the institute found the apps will save money.” * * *
    • “Elsewhere, advocates from the American Telemedicine Association’s advocacy arm, ATA Action, are preparing to brief lawmakers about data showing that Germany’s broad expansion of coverage for digital apps resulted in 234 million euros in spending from 2020 to 2024. The report, produced by Germany’s National Association of Statutory Health Insurance Funds, also found 861,000 total app activations. That’s a cost of about 271 euros per use.”
  • Fierce Healthcare adds,
    • “Employers are continuing to invest in their well-being programs, but they will be raising the bar for what’s expected from their vendors.
    • “The Business Group on Health released a survey looking at employer strategies around well-being initiatives, polling 131 firms that employ 11.2 million people collectively. The employers represent multiple sizes and geographies, with 60% being multinational.
    • “The survey found that 93% of employers intend to either maintain or expand their well-being programs for 2025. Most (73%) said they will keep their existing offerings, while 20% said they will grow.
    • “In tandem, 94% of those surveyed said they will be increasing the expectations they have for well-being program vendors to show improvements to outcomes. Jim Winkler, chief strategy officer for the Business Group, said during a media briefing that this isn’t a new trend but that employers are simply turning up the heat on these vendors.”
  • Per Institutes for Clinical and Economic Review news releases,
    • The Institute for Clinical and Economic Review (ICER) posted a Protocol today [May 19] outlining how it will conduct a new annual analysis titled the “Launch Price and Access Report,” which will examine launch prices and patient access for new FDA-approved treatments. This protocol was developed with input from a multi-stakeholder working group consisting of patient and consumer advocates, clinicians, policy experts, payers, and life science companies.”
  • and
    • The Institute for Clinical and Economic Review (ICER) announced today [May 20] that it will assess the comparative clinical effectiveness and value of cytisinicline (Achieve Life Sciences) for smoking cessation [which is the first new smoking cessation drug for many years].
    • The assessment will be publicly discussed during a meeting of the Midwest CEPAC in January 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • ICER’s website provides timelines of key posting dates and public comment periods for this assessment. 
  • Reuters reports,
    • “Online weight-loss company Noom has begun offering smaller doses of compounded versions of Novo Nordisk’s (NOVOb.CO) Wegovy as the U.S. drugs regulator clamps down on mass production of copies of the in-demand medicine.
    • “Noom will offer its version of compounded semaglutide – the active ingredient in Wegovy and diabetes drug Ozempic – as part of a program personalized for patients, which it says will comply with changing U.S. Food and Drug Administration regulations.”
  • Beckers Payer Issues informs us,
    • “CVS Health has named Creagh Milford, DO, as president of Oak Street Health.
    • “Dr. Milford has been with CVS since 2021, most recently serving as president of retail health. 
    • “I’m excited to start a new chapter at CVS Health as President of Oak Street Health, where I have the honor of developing and executing business strategy to further grow the organization,” he wrote on Linkedin on May 19. “As a practicing physician, I am passionate about providing consumer-centric primary care to patients — and Oak Street Health shares that passion, resulting in better experiences and outcomes for the older adults we serve.”

Weekend Update

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

From Washington, DC

  • The House Budget Committee will resume consideration of the budget reconciliation bill tonight at 10 pm ET.
  • The New York Times reports that “The Food and Drug Administration on Friday approved the Novavax Covid-19 vaccine, but only for older adults and for others over age 12 who have at least one medical condition that puts them at high risk from Covid.”

From the public health and medical research front,

  • The New York Times further reports,
    • “Surgeons in Southern California have performed the first human bladder transplant, introducing a new, potentially life-changing procedure for people with debilitating bladder conditions.
    • “The operation was performed earlier this month by a pair of surgeons from the University of California, Los Angeles, and the University of Southern California on a 41-year-old man who had lost much of his bladder capacity from treatments for a rare form of bladder cancer.
    • “I was a ticking time bomb,” the patient, Oscar Larrainzar, said on Thursday during a follow-up appointment with his doctors. “But now I have hope.”
    • “The doctors plan to perform bladder transplants in four more patients as part of a clinical trial to get a sense of outcomes like bladder capacity and graft complications before pursuing a larger trial to expand its use.”
  • and
    • “Kristin Kramer woke up early on a Tuesday morning 10 years ago because one of her dogs needed to go out. Then, a couple of odd things happened.
    • “When she tried to call her other dog, “I couldn’t speak,” she said. As she walked downstairs to let them into the yard, “I noticed that my right hand wasn’t working.”
    • “But she went back to bed, “which was totally stupid,” said Ms. Kramer, now 54, an office manager in Muncie, Ind. “It didn’t register that something major was happening,” especially because, reawakening an hour later, “I was perfectly fine.”
    • “So she “just kind of blew it off” and went to work.
    • “It’s a common response to the neurological symptoms that signal a T.I.A., a transient ischemic attack or ministroke. At least 240,000 Americans experience one each year, with the incidence increasing sharply with age.” * * *
    • “Now, a large epidemiological study by researchers at the University of Alabama at Birmingham, published in JAMA Neurology, points to another reason to take T.I.A.s seriously: Over five years, study participants’ performance on cognitive tests after a T.I.A. drops as steeply as it does among victims of a full-on stroke.” * * *
    • “An accompanying editorial by Dr. Eric Smith, a neurologist at the University of Calgary, was pointedly headlined “Transient Ischemic Attack — Not So Transient After All!”
  • Medscape adds,
    • Is it time for universal screening for atrial fibrillation (AF), the most commonly treated type of arrhythmia that sets people up for strokes?
    • The question is important. While estimates of prevalence vary, a recent study found AF affects about 4% of the adult population or about 10 million in the United States. More than 795,000 people in the United States have a strokeeach year, and AF is blamed for 1 in 7.
    • For now, however, US organizations that issue guidelines and many leading cardiologists agree: It’s not yet warranted and may result in anticoagulation overtreatment, along with what they call the “nontrivial” risk for bleeding from that treatment.
    • However, it’s definitely a stay tuned situation, as researchers continue to investigate whether widespread screening can reduce the number of strokes in the broad population, others look at the role of “smart” technology, and still others focus on subsets of the population that might benefit most from routine screening.
  • The Washington Post points out,
    • “Eating an unhealthy diet is tied to an earlier first period, a new analysis suggests.
    • “The study linked a girl’s first menstrual period — a milestone known as menarche — to what she ate, showing ties between potentially inflammatory diets rich in processed and refined foods, red meat and beverages such as soda and an earlier onset of menstruation.
    • “Published in Human Reproduction, the study looked at 7,530 participants in the Growing Up Today Study, an ongoing study that evaluates factors thought to influence health across a lifetime. Participants enrolled in 1996 and 2004 and answered questionnaires about diet and activity, general health, family history, demographic factors and when they got their first period.
    • “Researchers assessed participants’ diets using two rubrics: the Alternative Healthy Eating Index, a score based on participants’ adherence to a healthy diet, and the Empirical Dietary Inflammatory Pattern, which identifies diets linked to inflammation. These potentially inflammatory diets are higher in processed foods, beverages like soda and juice, and red meat.
    • “Ninety-three percent of participants started their period during the study, at a median age of 13.1 years. But the age of menarche varied among participants with different diets. Overall, having a healthier diet predicted later menarche, and those who ate the healthiest diet were 8 percent less likely to get their first period in the next month. The association remained after researchers adjusted for body mass index, height and neighborhood socioeconomic status.”

From the U.S. healthcare business front,

  • The Wall Street Journal let us know,
    • “A government crackdown on cheaper copies of Ozempic and similar diabetes and weight-loss drugs was intended to shut the door on that booming market.
    • “It hasn’t exactly worked out that way. 
    • “Instead, some compounding pharmacies and telehealth companies that make the copies have found new ways in. They are making and selling dosages slightly different from the standard, FDA-approved amounts or including additives such as vitamins B3 and B12. Others have changed how the drug is taken, switching from injectables to under the tongue drops or pills.
    • “These providers are relying on a law that allows bespoke versions of drugs that are unavailable commercially. Though some patients report delays in receiving the compounded medications, many are still getting them—at least for now—said patients and industry professionals. 
  • MedTech Dive tells us,
    • “Siemens Healthineers said Wednesday it is investing $150 million to expand production in the U.S.
    • “Siemens is relocating manufacturing operations for its radiation oncology business Varian from Mexico to the U.S. The company said the change will add around 50 jobs in California.
    • “The company is also building a 60,000 square foot “Experience Center” in North Carolina, investing $141 million in a research and innovation district that it has been involved with since 2023.”

Friday Report

David Ermer–CDC, Congress, COVID-19, FDA, Federal employment benefits, Generative AI, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “House Republican spending hawks blocked the party’s giant tax-and-spending bill on Friday, delivering President Trump a setback over disagreements on Medicaid, clean-energy tax breaks and budget deficits.
    • “The holdouts—Reps. Chip Roy of Texas, Ralph Norman of South Carolina, Josh Brecheen of Oklahoma and Andrew Clyde of Georgia—stopped the Budget Committee from advancing the legislation, which leaders hope to pass by the full House next week. The panel failed to move the bill on a 16-21 vote, with those four Republicans and Rep. Lloyd Smucker (R., Pa.) joining all Democrats in opposition. Smucker, who backs the measure, said he voted no for procedural reasons, so he can call for a revote later.
    • “Budget Committee Chairman Jodey Arrington (R., Texas) said lawmakers were close to agreements on making changes to win the necessary votes. The committee scheduled its session to resume at 10 p.m. Sunday.”
  • and
    • “The U.S. lost its last triple-A credit rating.
    • “Moody’s Ratings downgraded the U.S. government on Friday, citing large fiscal deficits and rising interest costs.
    • “Runaway budget deficits mean U.S. government borrowing will balloon at an accelerating rate, pushing interest rates up over the long term, Moody’s said. The firm said in a March report that fiscal weakness looked set to continue even under analysts’ best-case scenarios.”
  • Modern Healthcare adds,
    • “Long-sought legislation to monitor and restrict how pharmacy benefit mangers operate could finally pass — if Republicans can move their sweeping budget bill that includes a string of those provisions.
    • ‘New PBM measures are tucked into the bill advanced Wednesday by the House Energy and Commerce Committee, which aims to cut more than $880 billion in spending, including $625 billion from Medicaid. The restrictions have long been championed by Health Subcommittee Chair Buddy Carter (R-Ga.), who was a pharmacist before becoming a congressman.”
  • Per Govexec
    • “The Trump administration is abiding by a court order to pause layoffs across most federal agencies, but it is still finding ways to shrink the federal workforce through involuntary means. 
    • “The Housing and Urban Development Department has begun once again firing its probationary employees—those recently hired or promoted—through a process distinct and separate from a reduction in force. Other agencies, including the Labor Department and National Science Foundation, meanwhile, are walking back recent RIFs due to a court-issued temporary restraining order. 
    • “That order specifically prevented agencies from issuing layoffs or taking any action to implement their Agency RIF and Reorganization Plans, which were mandated by the Office of Management and Budget and the Office of Personnel Management earlier this year. Agencies that were on the cusp of implementing RIFs, such as the Interior Department, have put those plans on ice at least until the restraining order is set to expire after May 23.”
  • FedWeek called our attention to this OPM benefits administration letter about “Family Member Eligibility Verification Updates and Enrollment Processing.”
  • Fierce Pharma informs us,
    • “On the heels of a production-tinged executive order earlier this month, the Trump administration is doubling down on efforts to boost medicine manufacturing in the U.S.
    • “In a new public-private partnership spearheaded by the administration, the Department of Health and Human Services’ (HHS’) Administration for Strategic Preparedness and Response (ASPR) and the Defense Advanced Research Projects Agency (DARPA) are linking up with several universities and companies in a bid to improve manufacturing for essential medicines using technologies such as artificial intelligence, machine learning and informatics.
    • “The project, dubbed Equip-A-Pharma, will allow the federal agencies to work directly with Battelle Memorial Institute and Aprecia, Bright Path Laboratories, Rutgers University and Mark Cuban’s Cost Plus Drugs as the partners strive to boost domestic manufacturing of eight drugs and their active pharmaceutical ingredients, the ASPR said in a Thursday press release.”
  • STAT News reports,
    • “Optum, the health data and care provider division of UnitedHealth Group, is developing a way to calculate how sick Medicare patients are through artificial intelligence, instead of relying solely on diagnosis codes submitted by physicians.
    • “Ken Cohen, a physician and Optum’s executive director of translational research, said Thursday at a conference organized by America’s Physician Groups that he was working with the Duke-Margolis Institute for Health Policy on this “next generation” of Medicare risk coding using AI.”

From the FDA front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is for the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease.
    • “Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “Knowing that 10% of people aged 65 and older have Alzheimer’s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.”
  • STAT News adds,
    • “Jason Karlawish, a professor of medicine at the University of Pennsylvania who specializes in Alzheimer’s research, said that “used right, this is a test that could really help to improve the diagnostic experience.”
    • “But with the availability of easier-to-use tests, there’s always the risk of “some frisky prescribing habits,” Karlawish said. Particularly in the field of Alzheimer’s, where just a small number of doctors are trained to treat the increasingly common condition, “the outcome can be inappropriate prescribing of the tests because a lot of people have a desire to get it, but not a lot of clinicians know how to properly use it.”
    • “The test should only be used to help diagnose people who have confirmed cognitive impairment, and there’s a risk some doctors may skip the step of confirming, as it’s “much easier to order a test than it is to talk to a patient,” Karlawish said. 
    • “Still, “in the history of Alzheimer’s disease, this is a big day,” he said. “The notion 10 years ago that there’d be a blood test that detects the pathologies of Alzheimer’s was a bit of a science fiction fantasy kind of story, and now here it is FDA-approved and ready for clinical practice.”
  • Reuters points out,
    • “The U.S. Food and Drug Administration has approved Amneal Pharmaceuticals’ (AMRX.O), opens new tab self-administered migraine drug, giving way to a quick and more convenient treatment option for patients.
    • “The treatment, branded as Brekiya, delivers a single dose of the drug called dihydroergotamine mesylate via an autoinjector. It is approved for the treatment of acute cases of migraine and severe, one-sided pain in the head called cluster headaches in adults, the drugmaker said on Thursday.”

From the judicial front,

  • The American Hospital Association News informs us,
    • “A U.S. district court judge for the District of Columbia May 15 ruled the Department of Health and Human Services must preapprove the use of 340B “rebate models” before they can be implemented, which the department has not yet done for any of the models pursued by the plaintiff drug companies. 
    • “Judge Dabney Friedrich issued the ruling in a case brought by a number of drug companies, finding that when the statute says that in implementing price reductions, “any rebate or discount” taken into account shall be “as provided by the Secretary,” it means that HHS has the authority to approve or reject the proposed rebate models. “Put another way, the statute contemplates that the Secretary may ‘have as a condition’ or ‘stipulate’ how any rebate or discount is accounted for in the price ultimately paid by covered entities.” * * *
    • “HHS recently announced that it will be “in a position to provide guidance” about the drug industry’s proposed use of “rebate models” by the end of May.”

From the public health and medical research front.

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza, COVID-19, and RSV activity is low and declining.
    • “COVID-19
      • “COVID-19 activity has declined to low levels nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
      • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home.
    • “Influenza
    • “RSV
      • “RSV activity has declined to low levels in most areas of the country.”
  • The University of Minnesota CIDRAP notes,
    • “The US measles picture grew by 23 cases this week, according to today’s update from the Centers for Disease Control and Prevention (CDC).
    • “A total of 1,024 confirmed measle cases have been reported from 31 jurisdictions, with 14 outbreaks (defined as 3 or more related cases). Ninety-two percent of confirmed cases are outbreak-associated.
    • “Of the cases, 96% have occurred in people who are either unvaccinated or have unknown vaccination status, and 128 (13%) of case-patients have been hospitalized, including 69 children under the age of 5. Three deaths have been confirmed to date, including two in unvaccinated school-aged children.” * * *
    • “The CDC notes on its measles outbreak page that one the reasons for more measles activity is because MMR coverage among kindergartners is now below 95%—the level needed to maintain elimination status. Two doses of the MMR vaccine are 97% effective at preventing measles, and one dose is about 93% effective.”
  • The American Journal of Managed Care lets us know,
    • “Higher dietary inflammatory index (DII) scores are significantly associated with an increased risk of Alzheimer disease–related death among American adults, according to a study published in Experimental Gerontology.
    • “Although the exact mechanisms of Alzheimer disease remain unknown, accumulating evidence suggests that chronic inflammation plays a key role in its pathogenesis and progression. In particular, past research shows that neuroinflammation accelerates neuronal damage, synaptic loss, and cognitive decline observed in patients with Alzheimer disease.
    • “Anti-inflammatory diets can alleviate neuroinflammation in patients with Alzheimer disease by reducing systemic inflammation through several immune pathways in the brain and indirectly through the gut microbiome and body circulation pathways. Therefore, the researchers emphasized that an anti-inflammatory diet may constitute a beneficial nutritional approach in Alzheimer disease management.”
  • The Wall Street Journal reports
    • “Electricity is gaining traction as a potential treatment for diseases like cancer and rheumatoid arthritis.
    • “Companies like Novocure and SetPoint Medical are developing devices that use electricity to treat diseases.
    • “Clinical trials show promise, with devices extending survival for some cancer patients and improving arthritis symptoms.”
  • STAT News adds,
    • “Leading oncologists said this week that artificial intelligence will one day be as integrated into cancer care as it is in smartphones and self-driving cars — and that this is a change we should welcome.
    • “Their comments, made at STAT’s Breakthrough Summit West on Wednesday, reflected an optimistic view for how the health care system can use AI across nearly all aspects of cancer care, from matching patients with clinical trials to predicting how they might fare on a given treatment. Some of this work is already happening. The panelists noted that AI has the potential to offer deep expertise across a growing number of precisely defined cancer indications, and that the technology can generate insights research focused on individual hypotheses might miss.”

From the U.S. healthcare business front,

  • Beckers Hospital Review relates,
    • “Cleveland Clinic reported an operating income of $52.8 million (1.3% margin) in the first quarter, up slightly from $50.2 million (1.3% margin) in the same period last year, according to financial documents published May 16.”
  • and
    • “Phoenix-based Banner Health reported an operating income of $142.4 million (3.6% margin) in the first quarter, up from an $89.3 million operating gain (2.4% margin) in the first quarter of 2024, according to financial documents published May 15.”
  • Healthcare Dive reports,
    • “Rite Aid is selling more than 1,000 pharmacies to rival drugstore operators as the beleaguered “pharmacy chain limps through bankruptcy processes for a second time.
    • Rite Aid said it was formally pursuing sales of “substantially all of its assets” earlier this month. Now, healthcare companies CVS Health and Walgreens, along with grocery stores Albertsons, Kroger and Giant Eagle, are among the buyers snapping up Rite Aid stores, the company said on Thursday.
    • “CVS is one of the biggest buyers, agreeing to acquire prescription files from 625 Rite Aid locations in 15 states in areas where it already has a presence, along with fully buying and operating 64 stores in Idaho, Oregon and Washington. The sales are subject to approval by a New Jersey bankruptcy court, which is scheduled to hold a hearing on May 21 regarding the transactions.”
  • Fierce Healthcare tells us,
    • “More than 6 in 10 survey respondents say they expect their healthcare organizations to see higher revenue from value-based care arrangements this year than in 2024, according to a joint report from the National Association of Accountable ACOs and health tech company Innovaccer.
    • “The report surveyed 168 executive and clinical leaders at health systems, accountable care organizations, specialty providers, federally qualified health centers and other delivery organizations.
    • “The findings indicate a growing reliance on VBC programs for some organizations. A significant segment, 30%, of organizations said a quarter of their revenue is tied to VBC contracts. More than 20% indicated at least half of their revenue is derived from fully capitated or downside risk contracts.
    • “Three-fourths of respondents believe further financial support would propel VBC adoption more.”
  • The Wall Street Journal reports,
    • “Novo Nordisk CEO Lars Fruergaard Jorgensen is stepping down after eight years in the role.
    • “The move follows market challenges, a share-price decline, and pressure from its controlling foundation.
    • “Former CEO Lars Rebien Sorensen will join the board amid concerns about losing ground to Eli Lilly.”