Happy Juneteenth

SCOTUS

Happy Juneteenth

David Ermer–CDC, FDA, Medical / Rx research, SCOTUS, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Fierce Healthcare tells us,
    • “At AHIP’s annual conference, the trade group told reporters they oppose the reconciliation bill moving through Congress because of the impacts it would have on Medicaid and the individual market.
    • “AHIP executives said they will continue to work with other prominent healthcare organizations to convince lawmakers to protect federal health programs and help Americans remain insured—both by avoiding the harshest cuts and changes to Medicaid and the Affordable Care Act and extending the ACA enhanced premium tax credits.
    • “We are working arm in arm with hospitals, with physicians, with nurses, with patient advocates to try to mitigate these provisions,” said CEO Mike Tuffin. The group is continuing to meet with lawmakers and Congressional staff members to warn of dangers, should the bill pass.”
  • Per an HHS news release,
    • “Today, at the urging of Vice President JD Vance, under the leadership of U.S. Health and Human Services Robert F. Kennedy, Jr., the National Institutes of Health (NIH) launched a five-year, $10 million research initiative to assess and address the long-term health outcomes stemming from the 2023 train derailment in East Palestine, Ohio.” * * *
    • The multi-disciplinary, community-focused series of studies that will focus on:
      • “Longitudinal epidemiological research to understand the health impacts of exposures on short- and long-term health outcomes including relevant biological markers of risk.
      • “Public health tracking and surveillance of the community’s health conditions to support health care decisions and preventive measures.
      • “Extensive, well-coordinated, communications among researchers, study participants, community stakeholders, health care providers, government officials, and others to establish a comprehensive approach to address the affected communities’ health concerns.
    • “Technical details, application information, and other background material to the public were released today. It is expected that a series of grants will be issued to analyze various types of studies and community activities. The deadline to submit research proposals is July 21. Research projects to start this fall. Learn more here.”

From the public health front,

  • The Washington Post reports this afternoon,
    • Three people have died, and more than a dozen others were hospitalized following an outbreak of listeria that has been linked to premade chicken fettuccine alfredo meals sold nationwide at Kroger and Walmart, federal health officials said Wednesday.
    • FreshRealm, the Texas-based food manufacturer that makes the packaged products, issued a voluntary recall on Tuesday of chicken fettuccine alfredo meals made before June 17 “out of an abundance of caution,” the company said in a statement Wednesday.
    • “FreshRealm is issuing this voluntary recall strictly as a precautionary step with a full commitment to public health and safety,” the company said.
    • The outbreak spans 13 states, including Florida, North Carolina, Texas and Virginia, according to the Food and Drug Administration.
  • Medscape informs us,
    • “The upcoming American Diabetes Association (ADA) 85th Scientific Sessions will focus on new and evolving weight-loss treatments for people with and without diabetes, along with new biological and technological approaches for managing type 1 diabetes (T1D).
    • “Late-breaking symposia will include data from trials of a once-monthly injectable for obesity treatment, a nonpeptide oral GLP-1 receptor agonist (RA), and a medication combining a GLP-“1 RA with another drug designed to augment fat loss while preserving lean mass. Other new findings at the meeting include the use of a GLP-1 RA in T1D and the latest data on stem cell-derived islet cell transplantation in T1D. And always, there’s much more.
    • “The meeting will take place from June 20 to 24, 2025, in Chicago. “This year again, it will be heavily focused on obesity but more on the next generation of obesity drugs. We’re progressing to therapy that may be more amenable to the patient, with less frequent dosing and greater convenience,” Marlon Pragnell, PhD, ADA’s vice president of research and science, told Medscape Medical News.”
  • The New York Times reports,
    • “A cutting-edge cancer therapy offers hope for patients with lupus
    • “Lupus can be debilitating and sometimes deadly for the 3 million people who have it. A treatment called CAR-T appears to stop it in its tracks.”
  • STAT News lets us know,
    • Reliable communication for people with paralysis is nearing reality. Researchers have now demonstrated that a brain-computer interface can reliably translate thoughts into speech, including matching a person’s intended tone and pitch. 
    • It is the second study in as many months to validate the concept’s safety and initial efficacy. The findings are welcome news for a field that has spent decades trying to transform brain activity into reliable communication for people with paralysis. 
    • “Ten years ago … we were talking about point-and-click-based communication for people with paralysis,” said David Brandman, a study co-author and neurosurgeon at the University of California, Davis. “And now we’re talking about creating a digital voice box.”
    • “The findings were published in Nature on June 12. Brandman and the rest of the team showed that a 45-year-old man with amyotrophic lateral sclerosis was able to speak after having a device implanted into his brain.” 

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • Aetna has big plans to revamp the way it interacts with providers and policyholders, President Steve Nelson said during the AHIP 2025 conference this week.
    • The CVS Health subsidiary aims to eliminate some prior authorization requirements, automate precertification approvals and partner with health systems in hopes of smoothing over often-contentious relationships.
    • “We are going through a cultural transformation,” Nelson said in an interview Tuesday at the health insurance industry trade group AHIP’s event, which ran Monday through Wednesday.
    • “The initiative is part of CVS Health’s recently announced $20 billion, decade-long plan to improve the digital experience for members and providers. The healthcare conglomerate’s commitment is part of the larger trend of health insurance companies working to build trust amid widespread industry criticism that erupted after the fatal shooting of UnitedHealthcare CEO Brian Thompson in December.”
  • Per Becker Hospital Review,
    • “A new report from Vizient highlighted the 10 drug shortages placing the most pressure on U.S. hospitals, with the injectable lorazepam topping the list for both general and pediatric facilities. 
    • “These shortages [which are listed in the article] span a range of essential drug categories, including sedatives, crash cart medications, pain management treatments and oncology treatments.”
  • Modern Healthcare adds,
    • “As of April, bad debt as a percentage of gross revenue had increased at a median 2.9% year over year, according to an analysis from consulting firm Kaufman Hall, which pulled data from about 700 hospitals.
    • “Bad debt refers to revenue that providers were expecting to receive from patients or payers, but did not end up collecting despite multiple attempts. Providers often write off these unpaid balances once they are deemed uncollectible. 
    • “The unpaid balances are separate from charity care, which is free or discounted healthcare offered to patients who cannot otherwise pay for treatment. 
    • “Many hospitals are reaping the benefits of higher volumes, but more patients do not necessarily translate into a stronger balance sheet. Much of the payoff depends on payer mix. Hospitals serving a larger portion of uninsured patients or patients covered by government payer plans tend to be more at risk for bad debt balances.”

Midweek Update

David Ermer–CDC, CMS, FDA, Medicare, OPM, Patient safety, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Kelly Sikkema on Unsplash

From Washington, DC,

  • Roll Call tells us,
    • “Higher health care costs and a law Congress passed last year to boost retirement benefits for public sector workers worsened the long-term outlook of Social Security and Medicare trust funds, according to annual reports released Wednesday by the programs’ trustees. 
    • “The trust funds for Medicare and Social Security benefits would be depleted faster than expected compared to last year’s estimates, losing the ability to provide full benefits to retirees in some cases years earlier than previously projected.
    • “The Hospital Trust Fund will only be able to pay 100 percent of scheduled benefits until 2033, three years earlier than the trustees reported last year, according to the trustee report. After that point, the program will only be able to pay 89 percent of total scheduled benefits, a summary says.” * * *
    • “The long-term combined outlook of the Social Security Old-Age and Survivors Insurance Trust Fund and Disability Insurance Trust Fund worsened slightly, speeding up by about three calendar quarters compared to last year’s projection, thanks largely to the passage of a law last year that boosts benefits for public sector retirees.
    • “Absent congressional action to shore up the program, the Social Security Old-Age and Survivors Insurance Trust Fund would lose the ability to pay full benefits to retirees starting in the first quarter of 2033, at which point benefits would face a 23 percent cut. That’s the same calendar year projected last year, but the estimated depletion date moved up three calendar quarters, the trustees said in the report. 
    • “If combined with the Disability Trust Fund, which would require congressional action, the Social Security Trust Fund could pay out full benefits until the third quarter of 2034, three quarters earlier than last year’s 2035 projection. At that point, retirees would see their benefits cut by 19 percent.” 
  • Federal News Network informs us,
    • “The Trump administration is attempting to address what it says are inflated numbers of high-performing federal employees, while also telling agencies to swiftly discipline or remove any feds deemed poor performers.
    • “In a memo published Tuesday, the Office of Personnel Management told agencies to begin adopting a new performance management system designed by the Trump administration. The new system attempts to more strictly delineate between different levels of employee performance and encourage agencies to rate fewer employees as high performers.
    • “For many decades now, performance management across the federal workforce has fallen short of what the American people should expect,” OPM Acting Director Charles Ezell wrote in Tuesday’s memo to agencies. “Too often, this has resulted in a lack of accountability and inflated performance ratings.”
    • “OPM began its reform efforts earlier this year by updating the performance standards and expectations for career members of the Senior Executive Service, as well as those in Senior Level, Scientific and Professional positions. Those performance expectations are now being broadened to cover nearly all career federal employees.”
  • Healthcare Dive notes,
    • “A nascent form of health coverage that creates an alternative gateway for employers to offer Affordable Care Act coverage to their workers is seeing rising uptake, especially among midsize to large employers.
    • “Adoption of individual coverage health reimbursement arrangements, or ICHRA plans, rose 34% from 2024 to 2025 among employers with 50 or more full-time employees, according to a new report from trade association the HRA Council.
    • “Still, the vast majority of ICHRA users remain companies with fewer than 20 employees, most of which are providing health coverage for the first time through the arrangements, the HRA Council said.”
  • Beckers Hospital Review ranks States by percentage of Medicaid births using a new KFF analysis.

From the judicial front,

  • The Wall Street Journal reports,
    • “The Supreme Court cleared the way for states to restrict gender-transition treatments for minors, rejecting arguments that Tennessee’s ban on puberty blockers and other medical therapies amounted to unconstitutional discrimination. 
    • “Wednesday’s decision, which broke 6-3 along ideological lines, was the latest setback for transgender rights, after several months in which the Trump administration has adopted policies that range from expelling transgender personnel from the military to halting educational funding for states or institutions that permit transgender athletes on women’s sports teams. 
    • “This case carries with it the weight of fierce scientific and policy debates about the safety, efficacy, and propriety of medical treatments in an evolving field,” Chief Justice John Roberts wrote for the court. “The voices in these debates raise sincere concerns; the implications for all are profound,” he continued, but the Constitution “does not resolve these disagreements. Nor does it afford us license to decide them as we see best.”
    • “That task, he wrote, was best left to the legislature.”
  • KFF adds,
    • “As a result of the decision, minors across the US will continue to see their access to gender affirming care determined at least in part based on where they live. However, access to these services is being debated in venues beyond the judiciary, including in Congress and by the Trump Administration. The Trump Administration has taken a range of actions aimed at limiting access to gender affirming care, especially for minors and Congress too has taken up the issue. The reconciliation bill still being finalized includes a prohibition on Medicaid covering gender affirming care in Senate and House-passed versions. These efforts will likely face, and some cases already have faced, litigation. While the ruling on this case is quite limited (narrowly focused on equal protection claims and Tennessee’s ban), it could have some bearing on the outcome of future challenges.”
  • Bloomberg Law reports,
    • “A Biden administration rule prohibiting health care providers from sharing reproductive healthcare information with law enforcement was invalidated by a federal judge Wednesday.
    • “Judge Matthew J. Kacsmaryk ruled that the US Department of Health and Human Services’ rule was contrary to law since it illegally limits state public health laws, impermissibly re-defines “person” and “public health,” and oversteps the authority delegated by US Congress, he said in an opinion.” * * *
    • “The case is Purl v. Dep’t of Health and Human Services, N.D. Tex., No. 2:24-cv-00228, 6/18/25.”
  • Per Beckers Payer Issues,
    • “A former Medicare Advantage executive has been found not guilty of healthcare fraud. 
    • “A jury found Kenia Valle Boza, the former director of Medicare risk adjustment analytics for HealthSun Health Plans, not guilty of one count of conspiracy to commit healthcare fraud and wire fraud, and three counts of major fraud against the U.S., according to court documents. 
    • “The Department of Justice alleged Ms. Boza orchestrated a scheme to submit fraudulent and false information to CMS to increase the reimbursement HealthSun received from the federal government. 
    • “The department declined to prosecute HealthSun, which was acquired by Elevance Health in 2017, because of the organization’s “prompt voluntary self-disclosure, cooperation, and remediation,” according to a 2023 news release. The company also agreed to pay $53 million in repayments to the government.” 

From the Food and Drug Administration front,

  • STAT News points out,
    • “Vinay Prasad will now hold three separate jobs at the Food and Drug Administration, solidifying his position as a top adviser to Commissioner Marty Makary.
    • “Prasad will serve as the agency’s chief medical and scientific officer, in addition to leading the center that regulates vaccines, gene therapies, and the blood supply, according to an internal memo obtained by STAT. Traditionally, the agency’s chief scientist and chief medical officer have been two distinct roles. 
    • “In this capacity, he will serve as a trusted advisor to the FDA Commissioner and other senior officials on cross-cutting and emerging medical and scientific issues impacting regulatory science and public health,” Makary wrote in the memo announcing the news to staff. The agency didn’t immediately respond to a request for comment.
    • “The role greatly expands Prasad’s purview, giving him explicit authority to oversee and weigh in on regulatory issues in any center. He will advise Makary on medical policy and regulatory decisions and represent the FDA at advisory committee meetings and external forums.”
  • The Wall Street Journal reports,
    • “FDA approved Gilead’s Yeztugo, a twice-yearly injectable PrEP drug, showing 99.9% effectiveness in trials.
    • “Analysts project Yeztugo sales to reach $1.6 billion in 2028, posing competition to GSK’s Apretude.
    • “Yeztugo, priced at $28,218 annually, offers improved HIV prevention uptake.”
  • Per MedTech Dive,
    • “A problem with Dexcom’s receivers for its glucose sensors may cause people to not get an audible alert for low or high blood sugar levels, the Food and Drug Administration said in an enforcement report posted Monday. More than 2 million devices are affected by the Class I recall, the highest risk category.
    • “The receiver, a handheld device that gives glucose readings, may not provide an audible alert due to a manufacturing problem. Dexcom said in a letter to customers that, as of May, it had received 56 reports of severe adverse events, such as seizure, loss of consciousness, and other hypoglycemic or hyperglycemic symptoms. All of the people recovered, the company said.
    • ‘The recall applies to receivers associated with Dexcom’s G7, G6, One and One+ CGMs. Dexcom is asking users to return the affected devices and is offering replacements.”
  • and
    • “Q’Apel Medical has recalled a device for removing blood clots in the brain over an issue linked to two injuries, the Food and Drug Administration said Tuesday.
    • “The company asked customers to return Hippo 072 Aspiration Systems and Cheetah Delivery Tools after receiving a warning letter in which the FDA raised concerns about the device’s tip.
    • “Using the recalled devices may have serious adverse health consequences including contractions or tears in the blood vessels and death, the FDA said.”
  • and
    • Centerline Biomedical has recalled guidewires used in vascular procedures over a fault that could cause serious injury or death, the Food and Drug Administration said Friday.
    • The company has asked customers to return devices from the affected lots because the coating can come off during the procedure and be left inside the patient.
    • No customers have reported serious injuries or deaths associated with the fault. The potential for serious harm led the FDA to publish a Class I recall notice.

From the public health and medical research front,

  • The Washington Post reports,
    • “A simple test of your balance, strength and flexibility, known as the sitting-rising test, could be an early indicator of how long you’ll live, according to a large-scale new study of mobility and mortality.
    • “The study, published Wednesday in the European Journal of Preventive Cardiology, looked at how well 4,282 men and women aged between 46 and 75 could lower themselves from a standing position to the floor and then stand back up again with as little assistance as possible from their hands, knees, furniture or human helpers.
    • “The test assesses “all the aspects of fitness that are not aerobic,” said Claudio Gil Araújo, the study’s lead author and research director at an exercise-medicine clinic in Rio de Janeiro, where the data were collected. Those aspects include muscular health, balance, flexibility and body composition, he said, each of which is important for longevity and health.”
  • The New York Times relates,
    • As Americans scramble to respond to rising rates of suicidal behavior among youth, many policymakers have locked in on an alarming metric: the number of hours a day that American children spend glued to a glowing screen.
    • But a study published on Wednesday in the medical journal JAMA, which followed more than 4,000 children across the country, arrived at a surprising conclusion: Longer screen time at age 10 was not associated with higher rates of suicidal behavior four years later.
    • Instead, the authors found, the children at higher risk for suicidal behaviors were those who told researchers their use of technology had become “addictive” — that they had trouble putting it down or felt the need to use it more and more. Some children exhibited addictive behavior even if their screen time was relatively low, they said.
  • Health Day lets us know,
    • “People with severe depression who receive electroshock therapy are significantly less likely to commit suicide, a new evidence review says.
    • “Electroconvulsive therapy (ECT) lowered the risk of death by suicide 34% among patients with severe depression, according to findings published June 13 in the journal Neuroscience Applied.
    • “Depression patients receiving ECT also had a 30% lower risk of death from any cause, researchers said.
    • “They said these benefits might be even greater than reflected, given that ECT has improved as a psychiatric treatment.
    • “Modern ECT appears to be more effective than it was in the past,” said lead researcher Dr. Timur Liwinski, a clinician scientist at the University of Basel in Switzerland.
    • “Since our analysis spans many decades, it’s likely that today’s ECT offers even stronger protection against suicide than the 34% reduction we identified overall,” Liwinski said in a news release.”
  • Per MedPage Today,
    • “A meta-analysis of 24 observational studies confirms excess risks of heart attack, stroke, and cardiovascular death among cannabis users.
    • “The report joins a growing body of evidence linking cannabis use to significant health harms.
    • “Nevertheless, the meta-analysis was unable to account for cannabis mode of administration, product potency, or intensity of use.”
  • Per STAT News,
    • “Scholar Rock said Wednesday that its investigational therapy helped preserve lean mass among patients taking a powerful weight loss drug, as concerns grow that patients taking new obesity treatments may be losing too much muscle.”
  • CBS News reports,
    • “At least 3% of measles cases confirmed so far this year have been in people who received two doses of the measles vaccine, meaning they were fully vaccinated, the Centers for Disease Control and Prevention says. 
    • “About three dozen of the nearly 1,200 measles infections in 2025 have been in people with two vaccine doses, the agency said Friday in its weekly update on cases. An additional 2% of cases were in people who received at least one dose of the measles vaccine.
    • “Many of the cases were in Texas, which on Tuesday counted a 21st confirmed measles case in someone with at least two doses of the vaccine.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports from the AHIP 2025 conference which concluded today in Las Vegas.
    • “Medicare Advantage has historically enjoyed bipartisan popularity, but, as the program has grown, so too has scrutiny of insurers’ practices.
    • “Mike Hoak, vice president of public policy at Humana, said this is a natural cycle for public programs like MA, where policymakers don’t want to see it fail or kill it outright but want to continue evolving it to ensure it works effectively. 
    • “There was a similar reappraisal of Medicare Part D, he said.
    • “There is a really bipartisan feeling amongst policymakers: ‘I love the program,’ and—for some of them, at least—’I’d like to see it grow, but it is time for some nips and tucks,'” Hoak said. “I think Medicare Advantage is at that inflection point right now.”
  • and
    • Cigna Healthcare’s chief medical officer, Amy Flaster, M.D., joined the insurer at a difficult time for the industry.
    • Flaster stepped into the CMO role in December as health plans grappled with a wave of public outcry and frustration following the murder of UnitedHealthcare CEO Brian Thompson. 
    • She said in the wake of the shooting and public conversation that followed, the insurer “took time to reflect” on what its customers and society as a whole were saying and used that as fuel to make several “commitments to better” that are powering the company’s work moving forward.
    • “I think it was also an interesting turning point at Cigna, where we heard a lot of feedback and loud voices coming from society, from our customers, wanting to see a better system that serves their needs more efficiently, more effectively,” Flaster said in an interview with Fierce Healthcare at AHIP 2025.
  • Per Healthcare Dive,
    • “Ascension has entered a definitive agreement to acquire ambulatory surgery provider Amsurg, the nonprofit health system said Tuesday.
    • “The deal, which Ascension expects to close later this year pending regulatory approval, will add more than 250 ambulatory surgery centers across 34 states to Ascension’s outpatient portfolio.
    • “A spokesperson for the health system declined to comment on the size of the deal. However, sources told Bloomberg that Ascension was paying $3.9 billion for the provider.” 
  • Per Beckers Hospital Review,
    • “Mark Cuban’s Cost Plus Drug Co. and virtual care provider 9amHealth have partnered to offer obesity medications through a new program targeting self-insured employers. 
    • “Under the partnership, 9amHealth will use low-cost oral obesity medications sourced from Cost Plus Drugs alongside branded GLP-1 drugs acquired through direct manufacturer deals, according to a June 17 news release from the company. 
    • “The medications are a part of a broader obesity treatment program that includes telehealth-based support from clinicians specializing in conditions such as diabetes, high blood pressure and high cholesterol. 
    • “The program is aimed at employers who are looking to expand weight management coverage for workers without relying on traditional pharmacy benefit managers, the release said.” 
  • and
    • “Hospital labor costs related to drug shortage management have significantly increased, from $359 million in 2019 to $894 million in 2024 — a nearly 150% increase, according to a Vizient report published June 17. 
    • “Vizient surveyed 132 of its clients to measure the financial toll of medication shortages. Respondents included pharmacy and procurement leaders at health systems, medical centers, children’s hospitals, critical access hospitals, specialty hospitals, clinics and ambulatory care facilities. 
    • “Pediatric facilities were particularly strained, as they monitored 25% more shortages and exceeded pharmacy budgets more often than general facilities. 
    • “Overall, hospitals and other healthcare facilities spent 20.2 million hours in 2024 managing these shortages. In 2019, that figure was 8.6 million hours. 
    • “To cope, most facilities shifted workloads onto already stretched staff, while only a fraction opted to hire additional pharmacy personnel,” the report said. “These findings underscore an urgent issue: Drug shortages aren’t just about supply — they’re draining time, money and an already fragile healthcare system.”

Weekend Update

David Ermer–CDC, CMS, Congress, Medical / Rx research, Obesity, SCOTUS, U.S. Healthcare–

Happy belated Flay Day!

From Washington, DC

  • The Daily Caller explains,
    • The Senate’s confirmation of Trump nominees as of June 5 outpaced the Biden administration by 16 nominees and the first Trump administration by 33 nominees, according to information compiled by the Senate GOP leadership-aligned Senate Republicans Communications Center (SRCC).
    • Still, nearly 100 nominees are awaiting floor consideration, according to the Senate executive calendar.
    • The backlog is due in part to Senate Democrats placing blanket holds on hundreds of Trump nominees, requiring the Senate to use finite floor time to confirm each civilian nominee individually through multiple roll call votes. As a result, nearly 60% of the votes taken in the Senate during the 119th Congress have been related to nominations, according to the SRCC.
  • Roll Call summarizes other Senate work during this short workweek here.
  • The Supreme Court will be issuing opinions on Wednesday June 18 this week.
  • Tammy Flanagan, writing in Govexec, asks “Think you’re ready to tap your TSP? Here’s what you might be missing. Before touching your Thrift Savings Plan funds, make sure you understand the rules—and the risks—you might not have planned for.”

From the public health and medical research front.

  • STAT News reports,
    • “Sarepta Therapeutics said Sunday that it was halting shipments of its Duchenne muscular dystrophy gene therapy for patients who can no longer walk, following the death of a second [male] person who received the treatment.
    • “Sarepta disclosed the first patient death — a 16-year-old boy — in March. Both occurred from acute liver failure, a side effect that has been seen with other gene therapies. The company said both patients were non-ambulatory, meaning their disease had progressed to the point they relied on a wheelchair. Most children with Duchenne lose the ability to walk by adolescence.
    • “The company said early Sunday it was working with experts to come up with an enhanced immunosuppressive regimen that could make the therapy, called Elevidys, safer for non-ambulatory patients. It said it would talk with the Food and Drug Administration about the the proposed regimen. 
    • “Sarepta also said it was pausing dosing in an ongoing clinical trial of Elevidys, called ENVISION, that’s focused on older ambulatory and non-ambulatory patients.” 
  • Per Fortune Well,
    • “Researchers at the University of California San Francisco have identified the U.S. regions, as defined by the Centers for Disease Control and Prevention, where dementia occurs most often.
    • “The large and comprehensive study, published in JAMA Neurology, examined data on more than 12.6 million veterans 65 and older enrolled in the Veterans Health Administration system; only 2% were women. 
    • “Researchers found the highest incidence in the Southeast (North Carolina, South Carolina, Georgia, Florida) and the lowest in the Mid-Atlantic states (Delaware, Maryland, Pennsylvania, Virginia, West Virginia, New Jersey, Washington D.C.).” 
  • The Washington Post informs us,
    • A common genetic variant is linked to a doubled dementia risk for older men, a recent analysis in Neurology suggests.
    • The study used data from Aspirin in Reducing Events in the Elderly (ASPREE), which followed elderly patients in the United States and Australia with no history of cardiovascular disease, dementia or cognitive decline between 2010 and 2017.
    • Researchers focused on 12,174 Australians of European ancestry over age 70, and looked for variants in the HFE gene. The gene is critical to regulating the body’s iron levels, and variants are common among people of European descent.
    • Those who carry two copies of the p.C282Y variant in the HFE gene can develop hemochromatosis, a condition that causes iron overload in the body, and resulting conditions such as liver cirrhosis, liver cancer, frailty, arthritis and dementia.
    • One in 3 people carry a gene variant called H63D, and 1 in 36 carry two copies, John Olynyk, a professor at the Curtin Medical Research Institute in Perth, Australia, says in a news release about the new study.
    • “Having just one copy of this gene variant does not impact someone’s health or increase their risk of dementia. However, we found having two copies of the variant more than doubled the risk of dementia in [previously healthy] men, but not women,” Olynyk says.
  • NPR offers “Advice for trying GLP-1 drugs for weight loss from a doctor who’s been there.”
  • The New York Times reports,
    • “Many older people embrace vaccines. Research is proving them right.
    • “Newer formulations are even more effective at preventing illnesses that commonly afflict seniors — perhaps even dementia.”
  • and
    • “Many Falls Are Preventable. These Tips Can Help. Small changes and good habits make a difference.”
  • The Wall Street Journal reports,
    • When Officer Chelsea Johnston came across a wanted felon one evening in May, Johnston jerked her cruiser in front of him, sprinted after him and tackled him to the ground. Still catching her breath, Johnston motioned for someone to step out of the cruiser: Joy Bogese.
    • “Thank God,” the man said. “It’s you.” 
    • Bogese, who served time for financial crimes that fed a heroin addiction, now spends many of her evenings in a police cruiser as a recovery specialist helping people with addiction get into treatment. The man asked Bogese to help him get into a drug-treatment program at the local jail, where Bogese occasionally facilitates groups. 
    • She is part of a growing effort in Chesterfield County’s [Virginia] fight against addiction. In this county of nearly 400,000, overdose deaths have dropped by half in a single year—about double the decline of the rest of the country—to levels seen before the crisis began in 2015.
    • The precipitous drops have astounded public officials and health-policy experts, who have traveled across the country in an attempt to learn the formula and replicate it. Governors, members of Congress and sheriffs from as far away as Alaska have all come through, along with an acting U.S. drug czar.
  • Per Medscape,
    • “A prospective study found that increased consumption of olive oil was associated with a reduced risk for breast cancer, particularly oestrogen receptor–negative (ER−) and human epidermal growth factor receptor 2–negative (HER2−) breast cancers. A systematic review revealed that case-control studies more frequently reported this protective association, whereas prospective studies did not report any association.”

From the U.S. healthcare business front,

  • Kauffman Hall points out,
    • Mehmet Oz, MD, the new CMS Administrator, in a Senate confirmation hearing, expressed support for exploring multi-year products for Medicare Advantage. While his remarks were made in the context of avoiding unnecessary member churn and associated elevated broker commissions, there are much broader ramifications of transitioning from single-year to multi-year health plan products. His remarks have sparked interest in the industry to explore this idea further.” * * *
    • “Multi-year health plan products have the potential to change a lot about how healthcare business models work today. Given the inherent complexity, it is likely to be a slow journey towards the destination. Even so, incumbent health insurers and risk-bearing providers would be well-advised to start strategizing and building / experimenting with prototypes to manage their risk of being disrupted by multi-year-native health plan innovators. The new administration has already shown that it can move with alacrity and is not afraid to be disruptive in the process. The shift to multi-year plans could come sooner than expected. Or it may not. But in any case, it is better to be prepared.”
  • The FEHB Program was offered on a multi-year basis for two years in the 1980’s although an Open Season was held between the two years in which there were no benefit changes.
  • The Washington Post reports, “Nurse practitioners step in as geriatrician ranks shrink. Nurse practitioners are not trying to replace doctors — they’re trying to meet patients’ needs, wherever those patients are, an expert said.”
  • Per MedTech Dive,
    • “Chris Scoggins is taking the helm of Abbott’s diabetes business at a busy time for the company and the diabetes tech industry. Scoggins was promoted to Abbott’s executive vice president of diabetes care in December. Since then, Abbbott has collaborated with insulin pump firms Tandem Diabetes Care and Sequel Med Tech to integrate its planned glucose-ketone sensor with their devices. 
    • “Scoggins spoke with MedTech Dive about the company’s strategic approach ahead of the American Diabetes Association’s Scientific Sessions in June.”
    • The article includes the interview.

Weekend update

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

From Washington, DC,

  • The Senate maintains a daily Executive Calendar. There are now eight nominees whose names were reported to the Senate floor before Scott Kupor. According to the unanimous consent resolution page in the front of the calendar, the Senate will consider tomorrow the nominations of the earliest reported nominee David Fotouhi (March 13) and two nominees reported in May after Mr. Kupor (April 9). The FEHBlog think that this is the pattern that the Senate leadership is following, which means that the Senate is likely to take up Mr. Kupor’s nomination later this month. 
  • Roll Call summarizes expected Congressional activities for this week here.
    • As Senate committees continue to release their proposals for the House-passed reconciliation package this week, the House plans to vote on President Donald Trump’s proposals to rescind foreign aid and other spending, including for public broadcasting.
    • “The rescissions request sent to Congress by the Trump Administration takes the federal government in a new direction where we actually cut waste, fraud, and abuse and hold agencies accountable to the American people,” House Majority Leader Steve Scalise, R-La., said in a statement.
  • The Supreme Court will be issuing another batch of opinions this coming Thursday.
  • Last Thursday, HR Dive tells us,
    • “A federal appeals court’s “background circumstances” requirement for majority-group plaintiffs who seek to prove job discrimination cuts against both Title VII of the 1964 Civil Rights Act and U.S. Supreme Court precedent, Justice Ketanji Brown Jackson wrote for a unanimous SCOTUS on Thursday.
    • “The court reversed the 6th U.S. Circuit Court of Appeals’ decision in Ames v. Ohio Department of Youth Services, which had dismissed a heterosexual woman’s claim that she was unlawfully passed over for a promotion in favor of a lesbian woman and subsequently demoted, after which a gay man was hired to fill her original role. The plaintiff alleged that those decisions constituted illegal discrimination on the basis of her sexual orientation, which the Supreme Court has said is a form of sex-based discrimination under Title VII.
    • “The 6th Circuit held that the plaintiff could not show background circumstances to support her suspicion that her employer discriminated against her on the basis of her status as a member of a majority group.
    • “Justice Jackson, however, wrote that such requirements flout the Supreme Court’s case law, which “makes clear that the standard for proving disparate treatment under Title VII does not vary based on whether or not the plaintiff is a member of a majority group.”
    • “The court vacated and remanded the case to the 6th Circuit for further proceedings.”
  • Federal News Network interviews Tammy Flanagan about “what retiring feds need to know about their benefits in transition.”
    • “Timing is everything when thinking about when to drop your retirement paperwork. Understanding what happens to your leave balances, health insurance, and survivor benefits can inform that decision. Hear with more on those key considerations is the Founder and Principal Retirement specialist at Retire Federal, Tammy Flanagan.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP informs us,
    • “A new gene-tracking study in Nature shows that mpox spread among people in Nigeria for 8 years before it sparked a global outbreak in 2022.
    • “Using genomic tracing, researchers from Nigeria, the United States, Cameroon, Ethiopia, and Belgium estimate that the ancestor of the clade 2 mpox virus (mpxv) that ignited an international outbreak beginning in May 2022 first emerged in southern Nigeria in August 2014 and spread to 11 Nigerian states before human infections were detected in 2017. 
    • “In light of the findings, the authors write, “We need improved surveillance in the wildlife population in the forest systems to better understand the transmission and maintenance of MPXV in animal hosts,” as well as better human surveillance.
    • “We could have very easily prevented the 2022 multi-country outbreak if countries in Africa were given better access to therapeutics, vaccines, and surveillance technologies,” says first author Edyth Parker, PhD, MPhil, a researcher with the Institute of Genomics and Global Health and with the International Biosecurity and Biosafety Initiative for Science, in a Scripps Research news release. “In a vulnerably connected world, we cannot neglect epidemics until they get exported to the Global North.”
  • Medscape offers these reports from the recent American College of Obstetricians and Gynecologists (ACOG) 2025 Annual Meeting.
    • Changing the prescribing protocol for low-dose aspirin (LDA) for preeclampsia prevention from risk-based to universal significantly increased aspirin use in pregnant patients, based on new data presented at the American College of Obstetricians and Gynecologists (ACOG) 2025 Annual Meeting.
    • The use of LDA to reduce the risk for preeclampsia has been well established as an inexpensive and simple intervention, but it has remained underutilized nationwide, said lead author Meryl Y. Grimaldi, MD, of SBH Health System, New York City, in an interview.
    • “Many of the patients we care for at SBH Health are at high risk for preeclampsia, but we wanted to ensure that our eligible patients received the benefits of this intervention,” said Grimaldi, who presented the study at the meeting.
  • and
    • “Clinicians need to discuss and offer all patients a variety of pain management options for in-office gynecologic procedures ranging from intrauterine device (IUD) insertion to biopsies, according to new guidance published by the American College of Obstetricians and Gynecologists (ACOG). The guidelines, published on May 15, are the first formal ones from ACOG to not only acknowledge the range of pain experiences that can be associated with different procedures but also to explicitly lay out recommendations for the conversations providers should have with their patients about what pain management options are available.
    • “This guidance speaks to more than just Ob/Gyns,” Co-Author Genevieve Hofmann, DNP, women’s health nurse practitioner and assistant professor of Ob/Gyn at the University of Colorado School of Medicine in Aurora, Colorado, said during a discussion with the press on May 17 at American College of Obstetricians and Gynecologists (ACOG) Annual Meeting in Minneapolis. “It speaks to any physician who’s providing these types of services and certainly to advanced practice registered nurses who work in women’s health and provide these services.”
  • Medscape adds,
    • Regeneron said on Monday [June 2, 2025,] its experimental drug helped patients preserve up to 51% of lean mass and lose more fat when used in combination with Novo Nordisk’s popular obesity drug Wegovy in a mid-stage trial. 
    • In the 599-patient study, those on Wegovy alone lost about 7.9 pounds of muscle, while those on a combination of Regeneron’s trevogrumab and Wegovy lost up to 4.2 pounds. 
    • The combination helped patients shed up to 11.3% of their body weight compared with 10.4% for those on only Wegovy. 
    • The results mark an early win for Regeneron in the race against nearly a dozen companies to develop obesity treatments that preserve muscle, as they vie for a share of the potential $150 billion weight-loss drug market. 

From the U.S. healthcare business front,

  • Medical Economics “spoke with Mark McClellan, M.D., Ph.D., director, Duke-Margolis Institute for Health Policy, and a former administrator at CMS, about why value-based care hasn’t been adopted more quickly.” and let us know that “New Marit Health data from May, 2025, reveal that physicians feel most satisfied where compensation aligns with cost of living, practice expectations and quality of life. These 10 states show that perceived fairness matters just as much as raw earnings.”
  • The Wall Street Journal reports,
    • Unexpected healthcare costs can arise in retirement, such as uncovered drugs, isolation and concierge care.
    • Medicare Part D may not cover all drugs, potentially leading to high out-of-pocket expenses for uncovered medications.
    • Retirees may face unexpected travel costs for medical care based on retirement location or feel compelled to pay for concierge medical care.
  • All PSHB plans and Most FEHB plans offer Medicare Part D plans which are integrated with the regular plan formulary, thereby reducing one of the Journal’s identified risks.
  • Per BioPharma Dive,
    • “Hiroyuki Okuzawa holds an enviable position. The veteran Daiichi Sankyo executive took over as the Japanese drugmaker’s new CEO two months ago and inherited a company whose cancer medicines have, over the past half-decade, won it three of the pharmaceutical industry’s largest licensing deals.
    • “One of those medicines, the antibody-drug conjugate Enhertu, again took the spotlight at the American Society of Clinical Oncology’s annual meeting here, showing potential to become part of standard therapy for the frontline treatment of advanced breast cancer. It did the same in 2022 and 2024.
    • “Okuzawa can point to Enhertu and four other antibody-drug conjugates Daiichi Sankyo’s developing with AstraZeneca and Merck & Co. as proof of the strength of its research laboratories. By 2030, the company plansto have these five “ADCs” approved across more than 30 tumor types, which would allow it to treat nearly 400,000 cancer patients each year.
    • “We’d like to become one of the most important players in oncology,” said Okuzawa, noting aspirations to crack the top 10 companies by cancer drug sales. “Our senior leaders are now talking about not only top 10, but maybe top 5. We’re very much confident in our ADCs.”
  • Per Fierce Healthcare,
    • Neuroscience technology company Brooklyn Health is using artificial intelligence to target a fundamental problem in neurology and psychiatry: the flawed approach to mental health outcomes measurement.
    • The startup aims to modernize mental health measurement and scoring in central nervous system (CNS) drug development, an area of CNS research that faces limitations in objectivity and standardization. 
    • “Clinical interviews, the standard for symptom assessment, are fundamentally unreliable and imprecise,” said Anzar Abbas, Ph.D., a neuroscientist and founder of Brooklyn Health, in an interview.
    • “Brooklyn’s platform uses AI and digital phenotyping methods it developed to evaluate the quality and scoring of clinical interviews in real time.” * * *
    • “Brooklyn’s current focus in on drug development and central nervous system clinical trials to improve outcome measurement, essentially, how well a drug is working. But the company has ambitions beyond clinical trials to support outcome measurement across all forms of behavioral health delivery, including in-clinic psychiatric care and virtual mental health platforms.” 
  • The Washington Post reports on a smartphone app Death Clock AI that predicts how many years a user has left before beginning to push daisies as they day.

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.” 

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.”

Midweek Update

David Ermer–CMS, Congress, FDA, Medical / Rx research, Mental health care, Obesity, OPM, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare–

From Washington, DC

  • Per a House Oversight Committee press release,
    • “As part of the budget reconciliation process, the House Committee on Oversight and Government Reform held a markup today and passed budget legislation that advances President Trump’s agenda and saves American taxpayers over $50 billion. The Committee will now finalize its section of the budget legislation and transmit it directly to the House Committee on the Budget, which will compile and present the final package for consideration by the U.S. House of Representatives.”
  • Govexec provides details on the markup here.
  • Federal News Network tells us,
    • “Agencies are facing a roughly two-week deadline to show the Trump administration how they plan to implement coming changes for probationary employees.
    • “By May 16, agencies are expected to report their plans for adding a new “affirmative” certification requirement for probationary employees. Agencies are also expected to detail how they intend to train supervisors and HR practitioners on the coming changes, according to new guidance the Office of Personnel Management published Tuesday.
    • “The guidance outlines more detailed expectations for agencies to update how they manage probationary periods following President Donald Trump’s executive order last Thursday. That order called for the creation of “Civil Service Rule XI” and added a hurdle for probationary employees to clear before they become tenured employees. Agencies will now be required to review and actively sign off on probationary workers’ continued employment before they can reach a tenured employment status.”
  • Per Healthcare Dive,
    • “House Republicans are calling on the Center for Medicare and Medicaid Innovation to rethink its priorities under the Trump administration, including by improving transparency with providers and focusing on payment models that save the government money.
    • “In a letter sent this week by Republicans on the House Ways and Means Committee to CMS Administrator Dr. Mehmet Oz and CMMI Director Abe Sutton, lawmakers said they were “concerned” with the innovation center’s track record of creating models that often don’t improve care quality or reduce costs. 
    • “The legislators added that CMMI has also “promoted a political agenda ahead of its Congressionally mandated purpose,” like focusing on health equity instead of cost savings.” 

From the Food and Drug Administration front,

  • STAT News points out,
    • “Nearly 12% of Americans still smoke cigarettes, the leading cause of preventable death nationwide. Yet there are only two medications authorized by the Food and Drug Administration to help them quit — the more effective of which, varenicline, can come with unsavory side effects like nausea that make people less likely to stick with treatment.
    • “A new pill with fewer side effects could soon be available from the Washington state-based biotech Achieve Life Sciences. The company plans to file for FDA approval of its drug, called cytisinicline, in June. 
    • “Rick Stewart, Achieve’s co-founder and CEO, told STAT that he expects the drug to be approved in mid-2026 and to launch in the U.S. by the end of that year. “This will be the first new drug for nicotine dependence in nearly 20 years,” he said.” 
  • Fierce Healthcare informs us,
    • “While Johnson & Johnson isn’t the first to secure FDA approval for an FcRn-blocking antibody in myasthenia gravis, the New Jersey drugmaker is confident that a broad label will land its product an enviable market position in the long run.
    • “The FDA on Wednesday approved J&J’s nipocalimab under the brand name Imaavy as a new treatment option for generalized myasthenia gravis (gMG). The green light, which J&J says covers the “broadest population of people living with gMG,” includes patients ages 12 and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive.
    • “Anti-AChR and anti-MuSK antibody-positive people make up more than 90% of the total antibody-positive gMG population, J&J estimates. All told, the company figures gMG—which causes the communication between the body’s nerves and muscles to break down—affects around 700,000 people worldwide.”
  • Per MedTech Dive,
    • “Medtronic has won Food and Drug Administration approval for the Omniasecure defibrillation lead, the company said Friday.
    • “The lead connects to an implantable defibrillator and treats potentially life-threatening types of irregular heart rhythm. Medtronic said Omniasecure is the world’s smallest defibrillation lead.
    • “The approval limits the use of the lead to the right ventricle. Medtronic shared data on placing the lead in the left bundle branch last week but has yet to win FDA approval in that setting.
  • MedCity News lets us know,
    • “Patients with the most severe form of a certain inherited disease have skin that is susceptible to wounds, some that never fully heal. For years, the only treatment was supportive care, including laborious and frequent changes of wound dressings covering much of the body. Biotechnology research in this disease, epidermolysis bullosa (EB), has pursued therapeutic options. A personalized treatment that Abeona Therapeutics makes from a patient’s own skin cells is now approved by the FDA, marking the agency’s third approval in this rare disorder in the past two years.
    • “The regulatory decision announced Tuesday covers the treatment of wounds in adults and children who have recessive dystrophic epidermolysis bullosa (RDEB). The therapy, known in development as prademagene zamikeracel, or pz-cel for short, will be marketed under the brand name Zevaskyn. Cleveland-based Abeona expects Zevaskyn will become available in the third quarter of this year.
    • “We have heard from the RDEB community that there is a persistent, unmet need to meaningfully heal RDEB wounds, especially those that are chronic and prone to infection,” CEO Vishwas Seshdari said during a Tuesday morning conference call. “Through a single application, Zevaskyn can provide people with RDEB the opportunity for significant wound closure and pain reduction in even the most severe wounds.”

From the judicial front,

  • Federal News Network relates,
    • “The U.S. Supreme Court said Wednesday that federal employees who also are in the military reserve must be paid the equivalent of their civilian salaries when called to active duty during national emergencies.
    • “The 5-4 decision could affect hundreds of thousands of people, ensuring that they don’t suffer financially when they temporarily leave one form of government service for another.
    • “The justices ruled in an appeal filed by an air traffic controller who spent about five years on active duty in the Coast Guard at a pay rate lower than what he earns as a Federal Aviation Administration employee.”
  • Reuters reports,
    • “Genetic testing company 23andMe agreed on Tuesday to allow a court-appointed overseer to take charge of ensuring customers’ genetic data remains protected during the company’s bankruptcy, settling a dispute with several U.S. states.
    • “Those states had argued the company was not taking data security seriously enough.
    • “U.S. Bankruptcy Judge Brian Walsh approved the agreement at a court hearing in St. Louis, Missouri, ordering the appointment of a consumer protection ombudsman who will be empowered to review 23andMe’s handling of customers’ genetic information and its security policies.”

From the public health and medical research front,

  • CNBC reports,
    • “Aon researchers found that within two years, improved health outcomes for patients who were taking GLP-1 drugs lowers the growth rate of medical care costs. 
    • “Aon looked at medical claims data for 139,000 U.S.-based workers with employer health coverage who took GLP-1 medications between 2022 and 2024.
    • “Since 2023, GLP-1s have driven up employer spending on drugs at a faster pace than high-priced specialty drugs used to treat cancer and autoimmune conditions, according to an Evernorth study.”
  • Beckers Hospital Review considers what is driving increased use of GLP-1 drugs among children.
  • Per Cardiovascular Business,
    • “Drinking champagne may be associated with significant cardiovascular benefits, according to a new study published in the Canadian Journal of Cardiology.
    • “The study identified dozens of lifestyle changes that may help lower a person’s risk of sudden cardiac arrest (SCA). Some of the changes—eating more fruit, losing weight—were straightforward, but a few of the research team’s findings were unexpected. Drinking champagne and/or white wine, for example, was linked to a reduced SCA risk. The same was also true for spending more time at a computer—though that may tell us more about education levels than screen time.
    • “These findings all come from a new exposome-wide association study (EWAS) out of China. The study’s authors explored the UK Biobank study, focusing on data from more than 500,000 patients. They then looked for associations between SCA and 125 different modifiable lifestyle factors.
    • “To our knowledge, all previous studies on the risk factors of SCA were hypothesis-driven and focused on a limited number of candidate exposure factors grounded in previous knowledge or theoretical frameworks,” wrote first author Huihuan Luo, PhD, a researcher with Fudan University in Shanghai, China, and colleagues. “This might lead to publication bias distorting summary conclusions and might increase the likelihood of false positive findings resulting from inter-related exposures. More importantly, the hypothesis-driven approach might miss important exposures or relationships beyond the predefined hypothesis. To tackle these limitations, a hypothesis-free, data-driven EWAS has emerged as a robust analytical framework for simultaneously exploring hundreds of exposures. This data-driven approach does not rely on previous knowledge and facilitates the identification of novel or underexplored associations.” * * *
    • Click here for the full study.
  • Per Medscape,
    • “People with osteoarthritis are more likely to be diagnosed with other pain-related comorbidities such as fibromyalgia, chronic fatigue syndrome (CFS), gout, and irritable bowel syndrome and psychological comorbidities such as depression, according to observational data presented at the World Congress on Osteoarthritis (OARSI) 2025 Annual Meeting.
    • “The study also found that all these five conditions were themselves associated with an increased risk for incident osteoarthritis, and in the case of fibromyalgia, there may be a causal association.
    • “Physiotherapist and epidemiologist Subhashisa Swain, MPH, PhD, of the Nuffield Department of Primary Care Health Sciences at the University of Oxford, Oxford, England, presented an analysis of data from the multicenter European Comorbidities in Osteoarthritis (ComOA) study, which is examining electronic health records to identify associations between 61 different comorbidities with osteoarthritis and the clusters and trajectories of those comorbidities and osteoarthritis.”
  • The New York Times offers guidance on hip exercises.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Humana beat earnings expectations for the first quarter and reaffirmed its 2025 guidance on Wednesday, after medical costs came in as predicted. It’s a positive development for the insurer, which has been rocked by higher spending in privatized Medicare plans and the safety-net Medicaid program.
    • “Humana attributed the results to higher Medicare and Medicaid premiums and membership growth in Medicare prescription drug plans and state contracts. Earnings were offset somewhat by an ongoing decline in Medicare Advantage membership after Humana culled underperforming plans to resuscitate margins this year.
    • “However, it’s still early in 2025, so Humana is remaining cautious when it comes to medical utilization, executives said. The payer’s outlook is also complicated by uncertainty stemming from its ongoing legal bid to improve MA quality ratings.”
  • The American Hospital Association News notes,
    • “The AHA April 30 released a report highlighting how hospitals and health systems continue to experience significant financial headwinds that can challenge their ability to provide care to their patients and communities. The report outlines the financial burden of heightened expenses hospitals have faced in recent years in caring for patients, as well as the increasing strain on the field.  
    • “It explains how hospitals have raised wages to recruit and retain staff amid workforce shortages and how Medicare and Medicaid continue to underpay hospitals for patient care as shortfalls worsen. Other findings include how practices of certain Medicare Advantage plans exacerbate hospitals’ financial burden, and that tariffs on medical imports could significantly raise costs for hospitals as nearly 70% of medical devices marketed in the U.S. are manufactured exclusively overseas. 
    • “This report should serve as an alarm bell that a perfect storm of rising costs, inadequate reimbursement, and certain corporate insurer practices are jeopardizing the ability of hospitals to deliver high-quality, timely care to their communities,” said AHA President and CEO Rick Pollack. “With so much at stake, policymakers must recommit to making preserving access to hospital care a national priority.” 
  • The Wall Street Journal reports,
    • “Trump’s executive order on drug prices is seen as a win for the pharmaceutical industry.
    • “Drugmakers spent millions lobbying against pharmacy-benefit managers (PBMs), blaming them for high drug prices.
    • “PhRMA funded various groups, including minority healthcare nonprofits, to criticize PBMs.”
  • Per Fierce Healthcare,
    • “UnitedHealth Group announced Tuesday that Patrick Conway, M.D., would take the helm of its Optum division.
    • “Conway, an insurance industry and health policy veteran, was previously the CEO of Optum’s pharmacy benefit management unit, Optum Rx. He also held leadership roles at the company’s healthcare delivery arm, Optum Health.
    • “Conway will step in as CEO of Optum on May 6. His prior work includes serving as the director of the Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services, which is responsible for developing critical payment models for government insurance programs.”
  • and
    • “Despite the poor financial performance of BetterHelp, whose revenue fell by 11% in Q1, Teladoc has grown its investment in virtual mental healthcare by acquiring UpLift in a $30 million all-cash transaction.
    • “The deal closed on April 30, the same day as Teladoc’s first quarter 2025 earnings call. The company fared worse than Wall Street expected in Q1, posting a net loss of $93 million, or $0.53 lost per share. Wall Street Analysts expected the company share price to decrease by $0.33.
    • “A significant upside to the acquisition is the new-found ability for BetterHelp customers to use insurance coverage for mental health services, a barrier that has kept some customers from signing up with the cash-pay mental health provider. UpLift will be included in the company’s BetterHelp reporting segment going forward, executives said.
    • “UpLift provides virtual mental health therapy, psychiatry and medication management services. It serves the health plan market and covers 100 million lives. It has a network of over 1,500 mental health providers.”
  • Per BioPharma Dive,
    • “Novartis will pay $800 million upfront to acquire Regulus Therapeutics, a San Diego biotechnology company that launched nearly two decades ago with plans to make drugs capable of targeting small strips of nucleic acid known as microRNA.
    • “Announced Wednesday, the acquisition will hand the Swiss pharmaceutical firm a drug prospect called farabursen, which recently completed a Phase 1b study in people with autosomal dominant polycystic kidney disease, or ADPKD.
    • “Per deal terms, Regulus shareholders will receive $7 in cash per share, a premium of more than 100% to the stock’s closing price Tuesday. Additionally, Novartis has committed to pay an additional $7 per share via a so-called contingent value right that’s linked to the achievement of an unspecified regulatory milestone.”
  • and
    • “Sales of BridgeBio’s new heart medicine Attruby blew past analyst expectations in the first quarter, as the company built by “science nerds” took on market behemoth Pfizer.
    • “Net product revenue reached $36.7 million in the period, surpassing the consensus analyst estimate of $12.6 million. The drug won Food and Drug Administration approval in November to treat a genetic condition known as transthyretin amyloidosis with cardiomyopathy.
    • “As of April 25, Attruby had 2,072 prescriptions written by 756 prescribers, BridgeBio said Tuesday after the market closed. That momentum built on encouraging numbers released in February and helped push the company’s shares up in early trading Wednesday.”
  • Per Beckers Hospital Review,
    • “Mark Cuban Cost Plus Drug Co. has secured another partnership targeting the specialty pharmaceutical market, according to an April 28 news release shared with Becker’s. 
    • “EverPharm, a specialty unit-dose medication company, is joining its portfolio with Cost Plus Drugs’ pricing model, which is the drug’s manufacturing cost plus a 15% markup and a $10 shipping and labor fee. On April 16, Cost Plus Drugs launched a similar partnership with Morris & Dickson, a full-line and specialty pharmaceutical distributor. 
    • “The partnership with EverPharm will roll out in phases, the release said, with an initial focus on offering key unit-dose medicines to pharmacies and healthcare providers through the Cost Plus Marketplace.” 

Tuesday Report

David Ermer–CDC, CMS, Congress, FDA, HSA, Medical / Rx research, Medicare, NIH, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC,

  • The International Foundation of Employee Benefit Plans let us know,
    • Over a dozen bills that would amend the Internal Revenue Code of 1986 to expand health savings accounts (HSAs) have been introduced in Congress this year, according to the International Foundation’s [article]. If enacted, the bills aim to change the disadvantages of HSAs and/or high-deductible health plans (HDHPs) that make them inaccessible or undesirable to some people. If enacted, some bills would allow more people to own HSAs, contribute more annually, and use HSA dollars for more items and services. Other bills would change HDHPs to allow more than preventive services, such as chronic disease treatments, to be covered before the deductible.
  • Per a Senate Finance Committee news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will hold a nomination hearing on Tuesday, May 6, 2025, at 10:00 AM to consider James O’Neill to be Deputy Secretary of the Department of Health and Human Services (HHS) and Gary Andres to be an Assistant Secretary of HHS.”  
  • Beckers Payer Issues offers five notes on the Trump Administration’s approach to Medicare Advantage so far.
  • Modern Healthcare adds,
    • “Leaders at the Centers for Medicare and Medicaid Services are exploring proposals to limit health insurers’ use of tactics that can delay medical care, people familiar with the discussions said. 
    • “The aim of the proposals would be to cut the number of medical procedures subject to “prior authorization,” meaning ones in which doctors have to fill out additional paperwork for ultimate approval. CMS is exploring making policies more uniform across different health insurance plans. 
    • “Another goal is automating coverage determinations so patients can get decisions faster, said the people, who weren’t authorized to speak publicly on the matter. The discussions are in preliminary stages, and the agency’s direction could change.”
  • Modern Healthcare also shares some health insurer associations’ deregulatory ideas offered to the Trump Administration.
    • “The Coalition Against Surprise Medical Billing, which includes the health insurance trade group AHIP and the Blue Cross Blue Shield Association, wants CMS to make the No Surprises Act out-of-network billing dispute resolution process more favorable to their members, it wrote the White House, HHS, the Treasury Department and the Labor Department last Tuesday.
    • “The Alliance of Community Health Plans, which represents insurers affiliated with nonprofit health systems, wants CMS to nix a variety of quality and performance reporting requirements, including for defunct programs such as the Medicare Advantage Value-Based Insurance Design model, which CMS shut down last year.
    • “The association also wants CMS to ease rules regarding beneficiary communications, such as requiring them to opt into digital communications. These mandates are the “epitome of administrative burdens,” Alliance of Community Health Plans President and CEO Ceci Connelly wrote to CMS April 9.”
  • MedPage Today’s editor in chief interviews the new FDA Commissioner Marty Makary, MD, here.

From the judicial front,

  • STAT News reports,
    • “The Supreme Court on Tuesday rejected hospitals’ argument that the federal government doesn’t pay them enough for treating low-income patients [by a 7-2 majority].
    • “The seven-justice majority instead sided with the Department of Health and Human Services’ interpretation of the law concerning disproportionate share hospital, or DSH, payments, which compensate hospitals for treating low-income patients. More than 200 hospitals brought the case, Advocate Christ Medical Center v. Kennedy, arguing the federal agency’s misreading of the law causes it to underpay them by well over $1 billion each year.” 

From the public health and medical research front,

  • The National Institutes of Health (NIH) announced,
    • adopting a new initiative to expand innovative, human-based science while reducing animal use in research. Developing and using cutting-edge alternative nonanimal research models aligns with the U.S. Food and Drug Administration’s (FDA) recent initiative to reduce testing in animals. While traditional animal models continue to be vital to advancing scientific knowledge, using new and emerging technologies can offer unique strengths that, when utilized correctly or in combination, can expand the toolbox for researchers to answer previously difficult or unanswerable biomedical research questions.
    • “For decades, our biomedical research system has relied heavily on animal models. With this initiative, NIH is ushering in a new era of innovation,” said NIH Director Dr. Jay Bhattacharya. “By integrating advances in data science and technology with our growing understanding of human biology, we can fundamentally reimagine the way research is conducted—from clinical development to real-world application. This human-based approach will accelerate innovation, improve healthcare outcomes, and deliver life-changing treatments. It marks a critical leap forward for science, public trust, and patient care.”
  • The current issue of NIH Research Matters covers the following topics: “Restoring speech after paralysis | CT scans and cancer risks | Visual information processing in the brain.”
  • Health Day tells us,
    • “A Kaiser Permanente colon cancer screening initiative put a huge dent in cancer cases and deaths over two decades, a new study says.
    • “The systematic outreach program doubled colon cancer screening rates, researchers are scheduled to report at the upcoming Digestive Disease Week meeting in San Diego.
    • “As a result, cancer cases were cut by a third and colon cancer deaths by half, researchers report.
    • “In addition, racial disparities in colon cancer outcomes nearly vanished as a result of the initiative, researchers said.
    • “By offering an effective screening approach equally to everyone, we were able to eliminate much of the disparity,” said lead investigator Dr. Douglas Corley, chief research officer with the Kaiser Permanente Division of Research in Northern California.
    • “Ten years ago, there were big gaps in cancer risk and death, especially among our Black patients,” he said in a news release. “Now, those differences are nearly gone.”
  • MedPage Today informs us,
    • “The addition of the pregnancy checkbox on death certificates in 2003 was responsible for most of the spike in maternal deaths since 2000.
    • “However, in 2021, adjusted maternal death rates peaked at 18.86 per 100,000 live births, in line with the COVID pandemic.
    • “Of note, both infant and fetal death rates per 1,000 live births declined across the study period.” * * *
    • “Our work is the first to quantitatively separate out the effect of change in data collection from actual trends in maternal mortality,” co-author Robin Park, MSc, also of the University of Oxford, told MedPage Today. “Adjusting for the change in data collection, we find that the rate of maternal mortality has been relatively constant since 2000.”
    • “Park noted that while the checkbox doesn’t change the definition of maternal death, “anecdotal evidence suggests that it makes coders more likely to add a maternal or pregnancy-related cause of death,” and thus it’s been difficult for researchers to “parse out the true trends from changes in data collection.”
  • Per MedTech Dive,
    • “Since its U.S. debut more than a year ago, pulsed field ablation continues to gain converts at a fast pace, with devices from Boston Scientific and Medtronic leading the way.
    • “The procedure is becoming physicians’ preferred ablation method for treating atrial fibrillation, an irregular rhythm that can lead to complications such as blood clots, stroke and heart failure. PFA delivers electrical pulses to targeted areas of the heart causing abnormal rhythms, offering a potentially safer approach than older treatments that use heat or extreme cold to ablate the tissue.
    • “In connection with the Heart Rhythm Society’s 2025 meeting in San Diego, which wrapped this weekend, Boston Scientific, Medtronic, Abbott and Johnson & Johnson all unveiled data supporting their devices.
    • “Truist analysts, in a note to clients Sunday, said physicians they spoke with at the event reported that the more efficient PFA procedures were allowing their institutions to perform at least 20% to 30% more cases.”

From the U.S. healthcare business front,

  • Per a news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of tirzepatide (Zepbound®, Eli Lilly & Co.) and semaglutide (Wegovy®, Novo Nordisk) for the treatment of obesity. ICER will also assess how these treatments affect additional obesity-related outcomes.
    • “The assessment will be publicly discussed during a meeting of the New England CEPAC in November 2025, 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.“
  • The Wall Street Journal reports,
    • “AstraZeneca’s core EPS rose to $2.49, revenue increased 10% to $13.59B, but shares fell over 4% amid legal challenges in China.
    • “The company reaffirmed its 2025 targets after oncology revenue grew 13% to $5.64B, driven by Tagrisso and Imfinzi.
    • “China revenue rose 3%, but the company faces potential fines in the country over alleged illegal drug imports.”
  • and
    • “Hims & Hers partners with Novo Nordisk to offer Wegovy for weight loss, with subscriptions starting at $599 a month.
    • “The collaboration includes clinical support and nutrition guidance via Hims & Hers’ platform and NovoCare Pharmacy.
    • “Novo and Lilly are partnering with telehealth providers amid competition in the weight-loss drug market.”
  • and
    • “Merck is investing $1 billion in a Delaware plant to expand its U.S. manufacturing, amid potential tariff concerns.
    • “The plant will produce biologic drugs and a new, easier-to-use version of Keytruda, the company’s blockbuster cancer drug.
    • “The facility is Merck’s first in-house U.S. site for Keytruda, ensuring domestic supply and creating at least 500 on-site jobs.”
  • Per Healthcare Dive,
    • “Universal Health Services reported earnings for the first quarter on Monday evening that came in below Wall Street’s expectations for revenue. The for-profit’s behavioral health business also underperformed compared to its acute care service line.
    • “Behavioral health adjusted admissions declined by 1.6% compared to the prior year, while acute care admissions grew by 2.4%. Executives blamed the leap year in 2024 and atypical winter weather in some markets for depressed patient days, noting adolescent behavioral care utilization rates were particularly impacted by weather-related school closures. 
    • “CEO Marc Miller told investors during a Tuesday morning earnings call that UHS could get its behavioral health unit back on track to grow patient day revenue by 2.5% to 3% by the end of the year. However, the executive declined to specify when investors could expect to see improvement and dodged questions about whether volumes are expected to improve in the second quarter or the back half of the year.”
  • Per Fierce Healthcare,
    • “Though it opted to stick with annual guidance numbers given in February, Tenet Healthcare’s “outstanding” first-quarter performance has the company pushing ahead on growth initiatives in the face of financial headwinds and policy uncertainties.
    • “Tuesday morning, the hospital and ambulatory surgical center operator shared a $406 million net income attributable to the company ($4.27 per diluted share) for the first three months of the year. Net operating revenues decreased year over year from $5.4 billion to $5.2 billion, largely reflecting hospital divestitures during the prior year.
    • “Its adjusted EBITDA of $1.16 billion was up 14% over the same period a year prior and “well above the high end of our guidance range,” Chief Financial Officer Sun Park said Tuesday.
    • “Tenet CEO Saum Sutaria, M.D., told analysts that the earnings growth stems from divesting low-margin facilities and recent years’ focus on operating discipline. It’s set the stage for Tenet to continue focusing on labor structure and supply standardization, to increase its operating leverage and to build out its portfolio of well-performing assets.”
  • and
    • “Telehealth company LifeMD bought assets from Optimal Human Health MD to accelerate its push into the women’s health market.
    • “The acquisition establishes a scalable clinical and operational foundation for a comprehensive virtual health program, set to launch this summer, focused on hormone health, bone density, metabolism and long-term wellness. LifeMD’s virtual women’s health platform will target areas such as menopause and osteoporosis.
    • “The company did not disclose financial details of the acquisition.”
  • Modern Healthcare reports,
    • “Dr. Shawn Griffin, president and CEO of URAC, has had a front row seat to AI’s evolution in healthcare and he’s worried there are not enough guardrails.
    • “There is an urgent need for standards to be developed and quickly, given the change in presidential administrations, said Griffin, who six years ago became the first physician to lead the nonprofit accreditation organization for hospitals, health plans, telehealth providers, pharmacies and other healthcare players.”
    • “Looking at the way that AI was coming into healthcare, we recognized that there was a need for some sort of verifiable standards to be implemented to protect patients and to look out for their best interests in this area that’s moving so fast,” Griffin said. “It’s been on our radar screen for a few years.”
    • In the fall, URAC plans to launch a healthcare AI accreditation program, making it one of several organizations initiating these specific types of accreditation programs.

Friday Report

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Patient safety, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Today, the Supreme Court held a conference of its justices at which the Court decided next steps with the Kennedy v. Braidwood Management case heard last Monday.
  • Bloomberg Law reports that following the conference,
    • “The Supreme Court ordered more briefing after arguments in a dispute over Obamacare’s preventative services mandate, which requires insurers to cover certain treatments like cancer screenings free of charge.
    • “In an order on Friday, the justices asked the parties to address whether the health secretary has the power to appoint the members of the US Preventive Services Task Force, which recommends services that should be covered under the Affordable Care Act. 
    • “The court wants to know “whether Congress has ‘by Law’ vested” the secretary with this authority.” * * *
    • “Additional briefs are due May 5. It’s rare but not unheard of for the court to request more briefing after a case has been argued.
    • “This occasionally occurs on issues that come up during argument if they weren’t initially briefed by the parties.”
    • FEHBlog note — That’s exactly what happened in the Braidwood Management case.
  • STAT News tells us,
    • “The federal health department is not creating a new registry of Americans with autism, a Department of Health and Human Services official said in a written statement Thursday. Instead, the official said, HHS will launch a $50 million research effort to understand the causes of autism spectrum disorder and improve treatments.
    • “The announcement arrives two days after National Institutes of Health Director Jay Bhattacharya announced the intent to create such a registry at an all staff meeting, kicking off a firestorm of panic and confusion among autism self-advocates and the broader research community. Much of the fear centered around Bhattacharya’s remarks that the government would pull health data from private sources, such as electronic health records maintained by health care providers, pharmacy data, insurance claims and even wearables like smart watches and fitness trackers.”
  • Science Soft Healthcare predicts that “”By the end of 2026, 25–30% of all medical visits in the United States will be conducted via telemedicine. Although the adoption rate of telemedicine has been low in 2024, it will grow considerably with regulatory support from the US Congress.”
    • “In 2023, telemedicine usage in mental health was over three times higher than in other medical specialties, according to Epic Research. We believe that the resilient demand for telemedicine in mental health indicates that the technology is here to stay.”
  • The American Hospital Association News informs us,
    • “The Food and Drug Administration published a notice from Amneal Pharmaceutical that said the company is recalling two lots of its Ropivacaine Hydrochloride Injection 500mg/100mL Infusion bags due to the products potentially containing inert polypropylene fibers. As of April 18, Amneal Pharmaceuticals said it received no reports of adverse events or injuries related to the recall. The recalled IV bags were distributed nationwide to wholesalers and distributors from April 23-Nov. 8, 2024.”

In other judicial news,

  • STAT News reports,
    • “Novo Nordisk has notched a major legal win against compounding pharmacies that make copies of its diabetes and obesity drug semaglutide, sold under the brand names Ozempic and Wegovy.
    • “A federal judge on Thursday ruled against a compounding trade group’s request for a preliminary injunction that would have prevented the Food and Drug Administration from taking action against its members for making copies of semaglutide.
    • “Compounding pharmacies are legally allowed to make versions of branded treatments if the drugs are deemed to be in shortage by the FDA. For the two years when Ozempic and Wegovy were recently in shortage, compounders rushed to make copies to meet the enormous demand for weight loss treatments. But when semaglutide was ultimately taken off the FDA’s shortage list in February, the compounding trade group, called the Outsourcing Facilities Association, quickly sued the agency, arguing that there were still in actuality shortages of the branded treatments.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today:
    • “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
    • “COVID-19
      • “COVID-19 activity continues to decline 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 continues to decline in most areas of the country.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults.
    • “Other Respiratory Illnesses
      • “Mycoplasma pneumoniae
        • Respiratory infections caused by the bacteria Mycoplasma pneumoniae have increased in some areas of the United States over the last few weeks as indicated by emergency department visits and test positivity. M. pneumoniae infections are generally mild but can sometimes be severe, causing what’s known as “walking pneumonia.” Most people will recover without medicine, but some need antibiotics to get better. Learn more: About Mycoplasma pneumoniae Infection | M. pneumoniae | CDC.
      • “Pertussis
        • “Reported cases of whooping cough (pertussis) continue to be elevated nationwide but preliminary case reports have been trending downward for the past several months. Whooping cough is very contagious and can spread easily from person to person. Babies younger than 1 year old are at highest risk of severe disease and complications. The best way to prevent complications from whooping cough is to get vaccinated. Learn more: About Whooping Cough | Whooping Cough | CDC.“
  • The University of Minnesota’s CIDRAP adds,
    • “Flu activity continues to ebb nationwide, with rates of influenza-like illness (ILI) dropping further last week, but flu-related deaths in children climbed to 204, up 6 from the previous week, the Centers for Disease Control and Prevention (CDC) said in its weekly update today.”
  • The AHA News lets us know,
    • “There have been 884 confirmed cases of measles nationwide so far this year, with cases reported by 29 states, according to the latest data from the Centers for Disease Control and Prevention. There have been 11 outbreaks, and 93% of confirmed cases (820 of 884) are outbreak-associated. The vaccination status of 97% of all cases is classified as “unvaccinated or unknown.”
    • “The CDC April 24 released a report that said increasing national and local measles, mumps and rubella vaccination coverage is essential to preventing measles cases and outbreaks. The report also said that cases this year are the second highest in 25 years. A JAMA study also released April 24 found that measles could become endemic again within another 25 years if current childhood vaccination rates remain the same.”
  • The University of Minnesota’s CIDRAP drills down on these measles statistics.
  • Eating Well reports,
    • “A recall on a popular brand of apple juice sold in 28 states was just announced, according to the Food and Drug Administration. This is due to a potential contamination with patulin, a mycotoxin that can cause internal organ damage when consumed in excess. Approximately 173,616 bottles are affected by this recall.
    • “The product impacted is Martinelli Apple Juice sold in its signature clear, round glass bottles with a white metal screw top lid. The recalled 10-ounce apple juice bottles were sold in 4-packs, contain a UPC of “0 41244 04102 2” and have a best-by date of December 5, 2026. They were sold at retail locations in the following states: Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia and Wisconsin.
    • “This recall was just classified as a Class II recall, meaning that drinking this apple juice can  “cause temporary or medically reversible adverse health consequences,” per the FDA.
  • Healio points out,
    • An estimated 24,499 people visited the ED for adverse events related to semaglutide in the 2 years after its approval for weight loss, according to a study published in Annals of Internal Medicine.
    • The most common symptoms included nausea, vomiting and diarrhea, which had been previously documented in clinical trials. However, researchers also discovered that 16% of ED visits involved hypoglycemia.
    • “What I see in clinical practice is that some patients end up in the ED due to these severe symptoms from semaglutide, and it is not recognized in the ED,” Pieter Cohen, MD, associate professor of medicine at Harvard Medical School and internist at Cambridge Health Alliance, told Healio. “It is really important to make sure we are asking our patients about the use of semaglutide when they have these symptoms, particularly since use is so prevalent these days.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Centene beat Wall Street expectations for earnings and revenue in the first quarter thanks to significant membership increases, especially in Affordable Care Act and Medicare prescription drug plans, according to results released Friday.
    • “Citing the strong enrollment, the St. Louis-based payer raised its revenue guidance and reiterated its earnings guidance for 2025.
    • “However, Centene signaled medical costs may also be increasing, raising the outlook for its full-year medical loss ratio — a marker of spending on patient care. Centene’s stock fell 7% in Friday morning trade following the results.”
  • Per BioPharma Dive,
    • “Gilead Sciences on Thursday reported $6.7 billion in revenue in the first quarter, missing consensus Wall Street estimates as its cancer drug sales fell short of analyst expectations.  
    • “Gilead’s oncology portfolio generated $758 million in sales over the first three months of the year, down about 4% compared to the same period in 2024. Slower-than-expected sales of Gilead’s breast cancer drug Trodelvy were the main culprit, though the company also blamed lower demand for a decline in cancer cell therapy revenue.
    • “Gilead’s HIV drug business, though, helped offset those losses, garnering $4.6 billion and climbing 6% year over year. The company expects further growth in the future, as by June 19 the Food and Drug Administration could significantly expand use of lenacapavir, a twice-yearly injectable medicine proven in testing to prevent HIV infections.
  • Beckers Payer Issues provides 101 things to know about Blue Cross Blue Shield.
  • Beckers Hospital Review offers a list of the 25 most expensive hospital drugs.
  • Fierce Healthcare tells us,
    • “HCA Healthcare reaffirmed its 2025 guidance following an opening quarter of solid care demand and better-than-expected earnings.
    • “The country’s largest for-profit health system announced Friday morning $1.61 billion of net income attributable to the company ($6.45 per diluted share) and revenues of $18.32 billion for the first quarter. Both are improvements over the prior year’s $1.59 billion ($5.93 per diluted share) and $17.34 billion.
    • “Adjusted EBITDA for the quarter was $3.73 billion, also up from $3.35 billion in the first quarter of 2024.”
  • Per Fierce Pharma,
    • “With the potential for pharmaceutical import tariffs spurring a rush of life sciences investments in the U.S., AbbVie is joining the trend with plans to spend billions in the country over the next decade.
    • “AbbVie aims to invest $10 billion in the U.S. through 2035 to support its current growth plans and expand into new areas like obesity, the Chicago drugmaker’s CEO, Rob Michael, said on a call with analysts Friday.
    • “AbbVie’s executives did not go into the fine details of the domestic investment plan on the call, though the company’s CFO Scott Reents noted that a portion of the sum will be earmarked to build four new U.S. production facilities devoted to active pharmaceutical ingredients (API), drug product, peptides and devices.”
  • and
    • “After unveiling a new drug substance facility in North Carolina in December, Amgen is doubling down on expanding its U.S. production presence with plans for a major upgrade at its plant in central Ohio.
    • “The new project represents the latest in a string of pharma investments in the U.S. as the Trump administration threatens to clamp down on the industry with sector-specific import tariffs.
    • “Amgen is plugging $900 million into an expansion of its biomanufacturing facility in New Albany, Ohio, the company said Friday. The project is expected to bring the total number of Amgen jobs in the state to 750 and increase the company’s overall investment in Ohio to more than $1.4 billion.”

Thursday Report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Mental health care, NIH, OPM, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The American Hospital Association (AHA) News lets us know,
    • “Senate Health, Education, Labor, and Pensions Committee Chairman Bill Cassidy, M.D., R-La., today released a report detailing findings from an investigation into how covered entities use and generate revenue from the 340B Drug Pricing Program. As part of his investigation, Cassidy requested information from hospitals, Federally Qualified Health Centers, contract pharmacies and drug manufacturers.  
    • “Cassidy said the “investigation underscores that there are transparency and oversight concerns that prevent 340B discounts from translating to better access or lower costs for patients,” and the report outlines potential reforms needed to improve the program to better serve patients.   
    • “In a statement shared with media, AHA President and CEO Rick Pollack said, “The AHA appreciates Senator Cassidy’s leadership on 340B issues. As his report correctly observes, the 340B program was created to help hospitals reach more eligible patients and provide more comprehensive services. Even this investigation — which the report recognizes was ‘limited in scope’ given the variety of 340B hospitals across the country — demonstrates that hospitals use 340B savings to provide financial assistance to low-income patients and to maintain programs that enhance patient services and access to care. In short, 340B is vital in advancing health in communities across the country.”  
  • The President signed an executive order strengthening probationary periods in the federal civil service. Here’s a link to a fact sheet.
  • Govexec tells us, “Ex-feds launch websites to help unemployed civil servants find new jobs. Many federal employees are looking for positions outside of government following reductions in force and the Trump administration’s push for workers to take separation incentives.”
  • Per a Drug Enforcement Administration news release,
    • DEA’s National Prescription Drug Take Back Day is your chance to rid your medicine cabinet of unneeded and unwanted medications. Start your spring cleaning this year on April 26 by visiting a collection site near you.
    • Mark your calendar for this upcoming event! Participating drop-off sites will be open from 10 a.m. to 2 p.m. (local time) on Saturday, April 26. Collection sites are located around the country and will be collecting:
      • Tablets
      • Capsules
      • Patches
      • Other solid forms of prescription drugs.
  • The U.S. Preventive Services Task Force posted for public comment a draft research plan for evaluating a measure regarding “Vision in Children Ages 6 Months to 5 Years: Screening.” The public comment deadline is May 21, 2025.
  • Per the AHA News,
    • “The Food and Drug Administration has identified a Class I recall of Q’Apel Medical 072 Aspiration System after the company submitted three device event reports that included a tip detachment, a vessel rupture and a vasospasm.”

From the judicial front,

  • Professor Katie Keith wrote an article in Health Affairs Forefront about the Kennedy v. Braidwood Management oral argument presented to the Supreme Court last Monday.
  • Fierce Pharma informs us,
    • “Halozyme is not holding back against Merck & Co. in the companies’ injectable Keytruda patent dispute, having now escalated a verbal warning into a lawsuit.
    • “In a lawsuit filed Thursday in a New Jersey federal court, Halozyme alleges that a proposed subcutaneous formulation of Merck’s popular cancer drug Keytruda infringes 15 of its patents.
    • “Those intellectual properties belong to a Halozyme patent family called Mdase, which covers a large group of modified human hyaluronidases. A hyaluronidase protein may allow for under-the-skin administration of otherwise intravenously infused drugs.
    • “Halozyme is seeking an injunction to block Merck’s planned commercialization of subcutaneous (SC) Keytruda, which is under FDA review with a decision expected by Sept. 23. The San Diego drug delivery expert is also asking for monetary relief and “an enhancement of damages,” because the alleged infringement is said to be willful, according to its complaint.
    • “Even though SC Keytruda has not reached the market, Merck opened itself to patent litigation after publicly laying out its intention to launch the product this year pending FDA approval.”

In State government news,

  • Mercer offers a roundup of selected state healthcare developments in the first quarter of 2025.

From the public health and medical research front,

  • CNN reports,
    • “The United States has seen progress in reducing certain cancer risks, as overall smoking rates remain on a decline. But for other risk factors, such as those tied to cervical cancer, there is room for improvement, according to a new American Cancer Society report.
    • “The prevalence of people smoking fell from about 14% in 2019 to 11% in 2023, according to the report published Wednesday in the journal Cancer Epidemiology, Biomarkers & Prevention. Cigarette smoking is known to significantly increase the risk of developing cancer. It’s estimated to cause about 1 out of every 3 cancer deaths in the US. * * *
    • “The prevalence of people being up-to-date on recommended cervical cancer screenings has dropped from 74.8% in 2019 to 73.4% in 2021 among ages 21 to 65, the report found, leaving more women at risk of not detecting disease early. The reported noted that the decrease is alarming as HPV vaccination rates have remained “statistically unchanged” in recent years. In 2023, 61.4% of adolescents ages 13 to 17 were up-to-date for the HPV vaccination series, similar to 61.7% in 2021 and up from 54.2% in 2019.
    • “HPV or human papillomavirus is a group of more than 150 viruses that can cause certain types of cancer. Spread primarily through sexual contact, most cases of HPV clear on their own within two years, but when the infection does not go away, health problems like cancer may occur – which is why preventing these infections with vaccination has been key.”
  • The National Cancer Institute announced,
    • “Researchers have discovered what appears to be a critical biological driver of the most common form of ovarian cancer. The discovery, they believe, could spearhead the development of approaches for finding ovarian cancer at its earliest stages or preventing the disease from taking hold in the first place.
    • “Multiple studies have shown that high-grade serous ovarian cancer arises from precancerous growths called serous tubal intraepithelial carcinoma (STIC) lesions in the fallopian tubes. These lesions can eventually travel into the ovaries and transform into full-blown tumors.
    • “In this new study, Lan Coffman, M.D., Ph.D., of the University of Pittsburgh School of Medicine, and her colleagues showed that STIC lesions appear to arise and turn into tumors in the ovaries with the assistance of a type of stem cell that they called high-risk mesenchymal stem cells (MSCs).
    • “These high-risk MSCs—which have specific characteristics that appear to help their cancer-fueling capabilities—were abundant in the tissue, or stroma, immediately underneath STIC lesionsExit Disclaimer in fallopian tube tissue samples from women without cancer. They were also sometimes present in normal tissue. 
    • “When the researchers implanted high-risk MSCs along with healthy fallopian tube cells into mice, some developed ovarian cancer, including, in some cases, metastatic cancer, the researchers reported March 14 in Cancer Discovery.
    • “It’s not yet clear if high-risk MSCs are the primary instigator that causes healthy fallopian cells to transform into high-grade serous ovarian cancer, Dr. Coffman said, but the group’s findings support the idea that these cells are intimately involved. 
    • “What we believe we’re seeing is that [high-risk MSCs] are a supportive ‘soil’ for cancer initiation,” she said.”
  • Beckers Hospital Review adds,
    • “Some early-onset colorectal cancers may be caused by exposure to a bacterial toxin within the first 10 years of life, according to a study published April 23 in Nature.
    • “An international research team, led by Ludmil Alexandrov, PhD, from the University of California San Diego, analyzed 981 colorectal cancer genomes from patients across 11 countries for the study.” 
  • STAT News points out “Studies zoom in on clues to why Lyme disease persists and which antibiotic to prescribe. Cellular debris lingering in the liver and and a penicillin relative are identified.”
  • The AHA News tells us,
    • “A study published April 8 by the Public Library of Science’s Journal of Global Public Health found that driving while infected with COVID-19 raises the risk of an accident by 25%. The study analyzed public health and transportation data from seven states from 2020-2023. The results showed a significant association between acute COVID-19 infections and an increase in vehicle crashes.”
  • The Wall Street Journal reports,
    • A new study by French researchers found that some combinations of food additives were associated with a higher risk of Type 2 diabetes.
    • Researchers found that combinations of emulsifiers, colors and sweeteners increased the diabetes risk beyond what could be explained by individual substances alone.
    • Food-industry representatives defended combinations of what they said were safe ingredients, which they said are important for food safety and quality.
  • WTW notes, “Therapeutic alliance, the bond between client and therapist, is a game-changer in mental health programs. Employers must focus on measuring to predict better results and reduce dropout rates.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Merck’s first-quarter net income increased, driven by Keytruda sales, reaching $5.08 billion, or $2.01 a share, up from $4.76 billion year-over-year.
    • Despite sales of Keytruda rising 4% to $7.2 billion, Merck cut its 2025 adjusted earnings projection, citing tariffs and a license agreement.
    • Sales of HPV vaccine Gardasil fell 41% due to lower Chinese demand, while animal-health product sales rose 5% to $1.6 billion.
  • and
    • “Roche’s Q1 sales beat estimates due to demand for drugs like Ocrevus and Hemlibra.
    • “Roche is boosting its U.S. manufacturing to avoid potential tariffs, investing $50 billion over five years.
    • “Roche maintains its full-year guidance, anticipating mid-single-digit sales growth.”
  • Healthcare Dive adds,
    • “Molina beat analyst expectations for earnings and revenue in the first quarter, with a topline of $11.1 billion, up 12% year over year, and net income of $298 million, down 1% year over year, according to results released Wednesday.
    • “The California-based insurer said its medical costs increased moderately in the quarter, mostly due to utilization of long-term supports and services, expensive drugs and behavioral health, along with more spending on seasonal illnesses like the flu. However, costs were generally in line with what Molina had predicted, a bright spot after UnitedHealth, the largest private insurer in the U.S., reported an unexpected spike in spending earlier this month.
    • “Molina’s results can be viewed as “good enough,” TD Cowen analyst Ryan Langston wrote in a note on the insurer’s first quarter performance.”
  • Per BioPharma Dive,
    • Sanofi’s first-quarter sales and profit exceeded analyst expectations, but the company held tight on its full-year guidance amid looming threats of new tariffs from the Trump administration and regulatory uncertainty.
    • Sales climbed 9.7% to 9.9 billion euros, or $11.3 billion, in the period, beating the consensus analyst estimate of 9.6 billion euros. Earnings for the core business rose almost 16% to 1.79 euros a share, topping the consensus expectation of 1.70 euros a share.
    • The French drugmaker benefited from the launch of new drugs and the continuing growth of Dupixent, a blockbuster medicine used to treat conditions including asthma, eczema and chronic obstructive pulmonary disease. The drug’s sales jumped 20% to 3.5 billion euros in the quarter, Sanofi said Thursday.
  • Per MedTech Dive,
    • Medtronic is seeking Food and Drug Administration clearance for an interoperable version of its latest insulin pump, an important step in the manufacturer’s collaboration with diabetes technology rival Abbott. 
    • Medtronic said on Thursday that it made two 510(k) submissions to the FDA: one for its MiniMed 780G insulin pump as an alternate controller enabled device, and another for its SmartGuard insulin dosing algorithm as an interoperable automated glycemic controller.
    • The clearances would allow Medtronic’s technology to be part of an automated insulin delivery system, which can adjust insulin dosing to patients based on real-time readings from glucose monitors, using components made by other companies.
  • and
    • Edwards Lifesciences maintained full-year financial forecasts on Wednesday, projecting sales of its heart valves would offset hits from tariff and acquisition costs.
    • First-quarter sales of transcatheter aortic valve replacements, Edwards’ largest business, were better than the company expected, executives said on an earnings call.
    • Edwards’ TAVR sales were stifled last year by capacity constraints as heart teams performed more mitral and tricuspid valve procedures with the company’s newest devices. Hospitals are now addressing capacity issues by expanding capabilities for handling increased volumes, said Larry Wood, group president of TAVR and surgical structural heart. 
  • Modern Healthcare reports,
    • “Health systems have been shouldering the cost of mobile integrated healthcare programs for at-risk patients, but some insurers may be ready to start picking up the tab as providers prove they can save money.
    • “UMass Memorial Health, Geisinger, Prisma Health and others that operate these at-home care programs say the service saves millions of dollars by preventing emergency room visits and rehospitalizations of chronically ill patients. Government and private insurers have been covering little to none of the cost, but that could be changing as systems get information to prove the programs are effective.”
  • Mobihealth News informs us,
    • San Francisco-based Hinge Health, a digital musculoskeletal care platform, announced it is partnering with Cigna Healthcare to offer the health insurance company’s self-insured clients access to Hinge’s digital musculoskeletal (MSK) care platform. 
    • Hinge offers individuals with MSK conditions access to a multidisciplinary care team, including health coaches, orthopedic surgeons and physical therapists, as well as to digital tools like surgery decision support.
    • The company also provides a pelvic health program tailored for women and Enso, its FDA-cleared wearable that delivers electrical pulses to help alleviate everyday pain.
    • Cigna’s members who choose to enroll will have access to Hinge Health through Cigna’s condition-specific care program Pathwell Bone & Joint Solution.
    • Hinge touts that it is now an MSK provider for the five largest national health plans in the U.S. by self-insured lives. 
  • Per Fierce Healthcare,
    • “Health insurers can’t lose sight of improvements to the consumer experience as they find ways to reduce and manage rising costs, according to a new report from Forrester.
    • “The analysts offered one broad takeaway for payers: “Cut costs, not corners.” They noted that the industry is at a key crossroads where it’s critical to improve consumer experience and boost trust and consider those challenges as they build strategies around cost.
    • “Health insurers must improve CX, build consumer trust, and find innovative ways to create more sustainable cost structures and better economics for customers,” they wrote. “But the thirst for cost efficiency can’t cloud insurers’ strategic visions to create better health outcomes.”
  • Per Fierce Pharma,
    • “With the threat of Trump administration’s tariffs swirling and biopharma companies bracing for impact, many are announcing their intention to strengthen their presence in the U.S.
    • “The latest to hop on the invest-in-USA bandwagon is Thermo Fisher Scientific. The Massachusetts-based producer of medical instruments, diagnostics and pharmaceuticals will spend an additional $2 billion in the U.S. over the next four years “strengthening American innovation, manufacturing and economic competitiveness,” the company said in a release.
    • “Three-quarters of the pledge will bolster Thermo Fisher’s manufacturing operations, while the remaining $500 million will expand its R&D efforts.”