Midweek Update

Medicare

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.”

Tuesday report

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

From Washington, DC,

  • KFF compares the healthcare provisions in the House of Representatives big, beautiful bill against the developing Senate version. Of note the Senate version does not include the House bill’s provisions expanding the utility of health savings accounts.
  • STAT News adds,
    • “The Medicare pay bump for doctors that was part of the House version of Republicans’ tax bill was dropped in the Senate’s version, released Monday evening. 
    • “The provision, which would boost doctors’ payment for treating Medicare patients by tying it to inflation, has long been a top priority for physician groups.” 
  • Federal News Network tells 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.”
  • Radiology Business reports,
    • “Radiology Partners has “significantly outmatched other provider groups” via the No Surprises Act, scoring wins at more than 600% of the initial “qualifying payment amount” offer, according to new research. 
    • “The Centers for Medicare & Medicaid Services recently released NSA data from the first half of 2024. As Radiology Business reported previously, industry giant Rad Partners was the No. 1 initiator of these disputes tied to out-of-network healthcare services, with 136,784 between January and July. Georgetown University researchers recently took a closer look at the data, publishing their findings June 11 in Health Affairs. 
    • “They highlighted RP’s significant payment wins via the “independent dispute resolution” (IDR) process in 2024. In Q1, the practice earned a median prevailing offer at 631% of the qualifying payment amount—essentially, the median contracted rate for a service in the same geographic region. These wins continued in Q2, with a median at 610% of QPA.  
    • “These high numbers highlight the disconnect between the two sides as they debate what constitutes a reasonable payment for [out-of-network] services,” Jack Hoadley, PhD, research professor emeritus with Georgetown’s Center on Health Insurance Reforms, and co-authors explained. “Providers believe the high volume of IDR disputes reflects inadequate payment by plans, exacerbated by possible manipulation of the [qualifying payment amount]. Plans respond that their QPAs are accurate and that providers should be willing to accept payments that align closely with in-network rates.”P

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “Embracing artificial intelligence. Taking on companies that make ultra-processed foods. And offering a fast-track to approve drugs the Trump administration views as a priority.
    • “Welcome to the new Food and Drug Administration as envisioned by Dr. Marty Makary, who is leading the agency under Health Secretary Robert F. Kennedy Jr. Both men have said they want to overhaul the agency, citing what they see as the FDA’s reputation for coziness with pharmaceutical companies.
    • “Makary’s goal is “to deliver more transparency, unleash innovation, eliminate conflicts and lower drug pricing,” said Calley Means, a White House adviser and ally of Makary’s.
    • “The changes are coming so swiftly, and often without input from career scientists, that Makary faces declining staff morale threatening to stymie his efforts. He must also contend with the administration’s staff cuts at the FDA, which have been partly undone but shrank the workforce nonetheless. And critics say Makary is playing fast and loose with the FDA’s commitment to world-class science.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans. The new voucher may be redeemed by drug developers to participate in a novel priority program by the FDA that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission.
    • “The new CNPV process convenes experts from FDA offices for a team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices. Clinical information will be reviewed by a multidisciplinary team of physicians and scientists who will pre-review the submitted information and convene for a 1-day “tumor board style” meeting.
    • “Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public,” said FDA Commissioner Marty Makary M.D., M.P.H. “As a surgical oncologist, we often made multidisciplinary decisions with a team of doctors on major life-and-death questions for patients, incorporating the latest medical studies in a 1-day tumor board-style discussion. This voucher harnesses that model to deliver timely decisions for drug developers.”  
  • Per Modern Healthcare,
    • “Taiwanese surgical robotics company Brain Navi Biotechnology said Tuesday the Food and Drug Administration approved its NaoTrac neurosurgical robot.
    • “It’s designed to assist with brain tumor biopsies, deep brain stimulation and other complex brain surgeries.”
  • Per Cardiovascular Business,
    • “Inquis Medical, a California-based medtech company focused on peripheral vascular treatments, has received U.S. Food and Drug Administration (FDA) clearance for its Aventus Thrombectomy System to be used to treat pulmonary embolism (PE).
    • “The Aventus Thrombectomy System, a next-generation mechanical thrombectomy device, was previously cleared to target blood clots in a patient’s peripheral arteries. This new expanded clearance paves the way for PE patients to be treated using the same technology.”
  • Per MedTech Dive,
    • “Zyno Medical has recalled infusion pumps that shipped with software that had not undergone verification and validation testing, the Food and Drug Administration said Monday.
    • “The company released the Z-800 pumps with incorrect software versions. The software created a risk of incorrect air-in-line detection and audio alarms that could cause serious harm.
    • “Zyno has not reported any serious injuries or deaths. The recall, which the FDA assigned to Class I, started eight months after Zyno removed Z-800 pumps from use over another software issue.”

From the State law front,

  • Healthcare Dive reports,
    • “Iowa passed a law last week that places limits on pharmacy benefit managers, joining a growing number of states cracking down on the drug middlemen in an effort to constrain rising prescription drug costs and protect rural pharmacies. 
    • “The legislation includes numerous provisions aimed at tamping down on PBMs’ “outsized control” over the pharmaceutical supply chain, Gov. Kim Reynolds said in a statement. That includes preventing PBMs from steering patients to particular pharmacies, equalizing reimbursement between pharmacies and reforming how PBMs are paid.
    • “However, some experts have raised concerns that the law could lead to higher costs for health plans and patients.”

From the judicial front,

  • Bloomberg Law reports,
    • “The FDA lawfully determined that Novo Nordisk A/S’s Ozempic drug shortage ended and that drug compounders can’t keep making copies of the weight loss medicine, a federal judge ruled. 
    • “Judge Mark T. Pittman for the US District Court for the Northern District of Texas agreed with the Food and Drug Administration that it lawfully removed semaglutide from the drug shortage list last year, granting on June 13 the agency’s motion for summary judgment against compounders. 
    • “The opinion is currently sealed but will eventually be redacted, according to the court’s docket.”
    • The case number is 4:25-cv-00174.

From the public health and medical research front,

  • Cardiovascular Business reports,
    • “Mayo Clinic in Rochester, Minnesota, is the No. 1 heart hospital in the United States, according to a data-based ranking published by Newsweek. Cleveland Clinic and its Miller Family Heart, Vascular & Thoracic Institute came in at No. 2, followed by Massachusetts General Hospital/the Corrigan Minehan Heart Center at No. 3, NYU Langone Hospitals – Tisch Hospital at No. 4 and Stanford Health Care/Stanford Hospital at No. 5.
    • “The ranking is part of a new America’s Best Hospitals for Specialize Care 2025 report.
    • “Newsweek and Statista partnered on the list, naming their Top 200 Hospitals for Cardiac Care. While 45% of each facility’s overall score was determined by a variety of hospital quality metrics, another 35% was determined by survey responses from U.S. healthcare professionals collected in early 2025. In addition, 15% of the overall scores was determined by patient satisfaction surveys, and the final 5% was based on Statista’s PROMs Implementation Survey.“
  • Per Health Day,
    •  “Rheumatoid arthritis (RA) has steadily increased around the world during the past three decades, a new AI-powered study reports.
    • “The autoimmune disease affected 17.9 million people worldwide in 2021, a 13% increase from 1990, researchers reported today in the Annals of the Rheumatic Diseases.
    • “Results indicate that the global burden of RA has been vastly underestimated, researchers concluded.
    • “Further, the research team projects that rheumatoid arthritis will continue to increase unless steps are taken to prevent it or treat existing cases.”
  • and
    • “A new breakthrough can help people with schizophrenia keep up with their psychiatric meds, researchers said.
    • “A pill taken just once a week, gradually releasing medicine from within the stomach, can greatly simplify the drug schedule faced by schizophrenia patients, researchers reported June 10 in the journal The Lancet.
    • “The newly developed pill maintains consistent levels of the psychiatric drug risperidone in patient’s bodies, and controlled their symptoms just as well as daily doses, results showed.
    • “We’ve converted something that has to be taken once a day to once a week, orally, using a technology that can be adapted for a variety of medications,” researcher Giovanni Traverso, an associate professor of mechanical engineering at MIT, said in a news release.”
  • Per Beckers Hospital Review,
    • “A study found that a once-daily pill called obicetrapib significantly lowered LDL cholesterol in patients at high risk for heart disease. 
    • ‘The clinical trial, published May 7 in The New England Journal of Medicine, enrolled 2,500 participants with either a history of atherosclerotic cardiovascular disease or familial hypercholesterolemia, all of which were already taking the maximum tolerated doses of other cholesterol-lowering drugs. 
    • “After 84 days, those taking NewAmsterdam Pharma’s obicetrapib saw their LDL levels drop nearly 30% while the placebo group experienced a slight increase. The cholesterol-lowering effect was consistent across the treatment group and the rate of side effects was similar among the two groups.”
  • MedPage Today discusses “What the MAHA Report Gets Right, and Wrong, on Nutrition. Time will tell the impact of ensuing policies on health.”
  • and lets us know
    • “A rheumatology trainee who went on TikTok to find information on her own condition may have uncovered a novel and possibly tectonic approach to treating fibromyalgia, her presentation here suggested.
    • “That experience led to an analysis of the massive TriNetX medical records database, which indicated that fibromyalgia patients who used glucagon-like peptide-1 (GLP-1) receptor agonist drugs were less likely to use opioids and to report pain, fatigue, and malaise compared with propensity-matched non-users, according to Nouran Eshak, MBChB, of the Mayo Clinic in Scottsdale, Arizona.
    • “The findings were strong enough, Eshak told attendees at the European Alliance of Associations for Rheumatology annual meeting, that clinicians should “consider using GLP-1 agonists in fibromyalgia patients when comorbidities such as obesity, diabetes, or sleep apnea are present.” Those are approved indications for such agents, and therefore patients would face fewer barriers to access.
    • “Still, these findings are no substitute for prospective data, such as from randomized trials, Eshak stressed.”
  • The NIH’s Reseach Matters covers the following topics this week — “Y chromosome loss and cancer | Cysteine and weight loss | Treating malaria in mosquitoes.”
  • Per Medscape,
    • “When canagliflozin (Invokana) was approved in 2013, the SGLT2 inhibitor was touted as a first in a new medication class that was, at the time, the only oral, once-daily medication to reduce blood glucose as well as body weight and systolic blood pressure.
    • “Since then, additional SGLT2 inhibitors have been approved (dapagliflozin, empagliflozin, bexagliflozin, and ertugliflozin), and the indications for prescribing the medications have expanded.
    • “The medications have gone from targeting glucose-lowering to also providing cardiac protection, including for diabetes-free patients with heart failure.
    • “Next, experts said, discussions will focus on other decisions, such as when and whether to prescribe the SGLT2 inhibitors with GLP-1 receptor agonists for the best outcomes.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Eli Lilly agreed to buy Verve Therapeutics for $1 billion, betting on the promise of one-and-done gene therapies to treat cardiovascular disease. 
    • “The deal announced Tuesday offers Verve stockholders $10.50 a share, plus a contingent value right worth another $3 a share. The non-tradeable CVR would pay out if the company’s experimental VERVE-102 treatment advances enough to dose a patient in a Phase 3 trial within 10 years of the transaction’s closing.
    • “Verve CEO Sekar Kathiresan and other top stockholders have already agreed to tender shares that represent about 17.8% of Verve’s outstanding stock and the gene editing company’s board recommends that all investors agree to the tender offer, Lilly said. A second-step merger will follow if needed. The companies expect to complete the transaction in the third quarter.”
  • The Wall Street Journal reports,
    • “Dozens of companies have pledged to build more manufacturing in the U.S. since President Trump took office. Generic drugmakers aren’t among them. 
    • “And they have no plans to change that anytime soon.
    • “Makers of generics—cheaper copies that make up 90% of Americans’ prescription medications—say further domestic investment is too risky in such a low-margin and unpredictable business, unless the government helps to steady the sector. 
    • “Drugmakers want more clarity from the Trump administration on the potential pharmaceutical tariffs, which some companies warn could lead them to close U.S. plants altogether. 
    • “Where’s the incentive?” said Richard Saynor, chief executive officer of Sandoz, whose U.S. slate of roughly 150 generic drugs range from blood thinners to antipsychotics. “You sell a packet of antibiotics more cheaply than a packet of M&M’s. That’s offensive, and we lose money doing that.”
  • and
    • “Fresenius Medical Care could end up benefiting from blockbuster obesity drugs, according to its chief executive, contrary to concerns that such treatments could be negative for the dialysis specialist.
    • “I believe [the effect] is neutral to positive, not negative,” Fresenius Medical Care’s Chief Executive Helen Giza said in an interview.
    • “Ozempic and others in the class of drugs known as GLP-1 have shown promise in clinical trials beyond their most common uses for diabetes and weight loss to treat heart, kidney and liver diseases, among a growing list of conditions. As signs of their potential emerged, investors raced to look for winners and losers.”
  • Per STAT News,
    • “A central theme in Humana’s plan for boosting Medicare Advantage profitability in the future is a strategy its peers have relied on for over a decade: coaxing members in for their annual wellness visits.”
  • Per Fierce Healthcare,
    • “Lark Health is rolling out a new, artificial-intelligence-enabled platform to manage the costs related to GLP-1s, and it has tapped a former insurance industry executive to lead the charge.
    • “Matthew Gibbs, who previously served as chief pharmacy officer at Blue Shield of California, will join Lark as president. In that role, he will spearhead the launch of LarkVantage, a platform designed to mitigate the challenges associated with utilization reviews for GLP-1s.”
  • Reuters informs us,
    • “Eli Lilly (LLY.N) will ship the two highest doses of its popular weight-loss drug Zepbound to cash-paying customers on its website starting early August, the U.S. drugmaker said on Monday.
    • “With the addition of the 12.5 milligrams and 15 mg doses, all approved doses of Zepbound will be available on the website in single-dose vials for $499 per month or less, regardless of insurance status, the company said.
    • “Lilly and rival Novo Nordisk (NOVOb.CO), opens new tab started offering vials at discounted prices on their respective websites to expand access and stave off competition from compounded versions or cheaper copies of their weight-loss drugs.
    • “The LillyDirect website was launched last year to help patients directly order some drugs.”

Tuesday report

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

From Washington, DC,

  • Politico reports,
    • “House Republicans have finalized changes to the party-line tax and spending package the chamber passed last month, to keep the bill in compliance with Senate rules. 
    • “An early copy of the amendment House Republicans plan to adopt this week, first obtained by POLITICO, would remove $2 billion for Pentagon military intelligence programs and strike policy that would have allowed mining in a protected wilderness in the Midwest, among other changes. By nixing items the Senate parliamentarian has flagged, the bill will retain its “privilege” and has a chance at passing the Senate without having to overcome the filibuster.
    • “House GOP leaders plan to adopt the tweaks on the floor Wednesday, according to House Majority Leader Steve Scalise. 
    • “So, the House doesn’t have to vote again on passage of the bill that was difficult to whip the first time, the changes will be adopted through a fast-track tactic. By approving a resolution this week to tee up floor debate on a separate bill, the House will be voting to amend the megabill before it is officially transmitted to the Senate.”
  • Fierce Pharma tells us,
    • “As President Donald Trump vows to bridge the drug pricing gap between the U.S. and other developed countries with his “most favored nation” (MFN) policy, Pfizer CEO Albert Bourla is calling for a U.S. government-led push to increase overall drug spending outside the U.S.
    • “While the exact mechanism of implementing MFN to reduce drug prices in the U.S. remains unclear, Bourla proposed (PDF) that other countries should spend a certain percentage of their GDP per capita on innovative medicines.
    • “Bourla laid out the concept Monday at the Goldman Sachs annual global healthcare conference, drawing a comparison to how members of the North Atlantic Treaty Organization (NATO) have agreed to commit 2% of their national GDP to defense spending.
    • “The U.S. is spending about 0.8% of GDP per capita on innovative drugs within 10 years of their launch, Bourla said. That’s higher than the 0.5% by Italy and Spain, or 0.4% in Germany, while the U.K. is spending about 0.3%, he said.” * * *
    • “To Bourla, reining in U.S. drug costs and increasing foreign countries’ expenditures are two sides of the same coin. In the U.S., it remains to be seen how the health department will enforce MFN, and Bourla said he doesn’t expect the industry will gain much clarity anytime soon.”
  • MedCity News opines,
    • “[P]olicy leaders overlook the fact that IVF is priced at around $20,000 per cycle because the system can’t expand to meet demand. Adding more insurance money will only inflate the queue, unless general insurers follow the lead of specialized fertility insurers that focus on actual outcomes; they have every incentive to keep costs controlled and success rates high. We risk repeating what happened in higher education, when the federal government expanded funding for college without restraining the total price. College prices continue to rise far faster than inflation. This is not a mistake we can afford with IVF.
    • “President Trump’s plan to fix IVF might look bold in a headline. In reality, it doesn’t create a single new embryology lab. It doesn’t hire one more specialist. It won’t change the fact that right now, only people with plenty of money can afford IVF, and throwing subsidies at a market that’s already bottlenecked only shifts who pays. If we keep ignoring capacity, we prolong the same heartbreak and keep IVF out of reach for many hopeful parents.
    • “We need more clinics, cutting-edge automation, and better oversight so clinics aren’t pressured to cut corners or limit embryo transfers just to stretch funding. We need a fundamental restructuring that rewards a successful pregnancy rather than a never-ending list of procedures.”
  • Per Beckers Payer Issues,
    • “Groups representing insurers are pushing back on proposed tighter regulations on Medicare Advantage coding. 
    • “Senate Republicans are considering targeted changes to Medicare Advantage as part of the sweeping “One Big Beautiful Bill.” Lawmakers are considering adding provisions of the No UPCODE Act to the package. 
    • “The bipartisan proposal was first floated by Sens. Bill Cassidy, MD, and Jeff Merkley in 2023, and would make changes to the risk-adjustment model MA plans use to bill the federal government and limit the ability to include old or unrelated medical conditions in the cost of care.”
  • Per a CMS news release,
    • “As he turns 65 on Wednesday, June 11, CMS Administrator Dr. Mehmet Oz is using his own Medicare enrollment experience to help Americans better understand how to sign up for Medicare and select the coverage that best fits their needs. Through a new video and social media series, Dr. Oz is walking future enrollees through simple steps they can take to get started—beginning with Medicare.gov.
    • Dr. Oz’s public service messages highlight key reminders for those approaching Medicare eligibility:
      • Start early to learn about options.
      • Enrollment paths may vary depending on whether someone is already receiving Social Security benefits or whether you are still working and have employer coverage.
        Use Medicare.gov to get clear, personalized guidance on enrollment and coverage.
      • To watch Dr. Oz’s messages, visit: 
        Dr. Mehmet Oz displays his Medicare card
  • JAMA Open informs us,
    • “The findings of a cross-sectional study suggest that although 988 has been contacted more than 16 million times since its launch [in July 2022], there remains opportunity to increase 988 use. For example, the past-year 988 contact rate of 23.7 per 1000 is less than half that of the rate of adult emergency department visits that include a mental health diagnosis (53.0 per 1000 population).4 Furthermore, there was regional and state-level variation in 988 use. This is consistent with state variation in funding for and legislative attention toward 988, both of which may affect awareness and use. Lower rates of 988 use in the South, which is more politically conservative than other regions, is also consistent with prior research showing less favorable attitudes toward 988 among Republicans than Democrats.
    • “Study limitations relate to 988 contacts being assigned to states according to area code, uncertainty about the 988 repeat contact rates, and state-level variation in the existence of other crisis lines that are not part of the 988 network. Despite these inherent data limitations, our findings suggest that there are opportunities to increase 988 use, especially in southern states.”

From the public health and medical research front,

  • Healio lets us know,
    • “Data show men were less likely to seek care for diabetes, HIV/AIDS and hypertension.
    • “More research is needed to track gender-related health risks and how they change over time, a researcher told Healio.”
  • MedPage Today points out,
    • “Active transportation modes in midlife — notably, cycling — were tied to a lower dementia risk over 13 years.
    • “Cycling was also associated with higher hippocampal volume.”
  • Cardiovascular Business reports,
    • “A nationwide data analysis found that nearly one-third of U.S. adults with hypertension may be eligible for therapy by two catheter renal denervation (RDN) devices cleared by U.S. Food and Drug Administration (FDA). However, the study’s authors noted that eligibility alone does not indicate which of the 35 million patients are most likely to benefit from the treatment. The study was published June 4 online in JACC: Interventions.[1]
    • “Co-author of the study Eric Secemsky, MD—a cardiologist and researcher from Beth Israel Deaconess Medical Center and Harvard Medical—and his team used data from the National Health and Nutrition Examination Survey (NHANES) to estimate the proportion of hypertension patients who meet the FDA’s criteria for consideration of RDN.
    • “The researchers then broke down how many patients would qualify for RDN using the same criteria of each study for the two approved devices. They also looked at how many patients would qualify under the Society for Cardiovascular Angiography and Interventions (SCAI) 2023 RDN position statement on patient selection and best practices.
    • “The authors found that on-medication, sham-controlled randomized trials had the most selective enrollment criteria, matching only about 2% of U.S. adults with hypertension. In contrast, U.S. single-arm registries and the SCAI 2023 position statement estimated a much larger potential eligibility, approaching 25 million Americans. This discrepancy underscores the challenge of generalizing highly selective trial results to a broader patient population in real-world settings.”
  • MedCity News lets us know,
    • “An experimental Metsera obesity drug led to an average 8.4% weight loss(Opens in a new window) in a small clinical trial, preliminary results that keep the biotech competitive in the crowded mix of companies pursuing a promising new metabolic target, but with the potential to offer less frequent dosing than its rivals.
    • “The drug, MET-233i, is a peptide engineered to activate amylin, a hormone that, like GLP-1, plays a role in regulating blood sugar and appetite. New York-based Metsera designed MET-233i with technology enabling the medication to last longer in the body.
    • “The 8.4% weight loss mark reported Monday was achieved by the 1.2 mg dose, the highest of four doses of the drug administered weekly for five weeks in a two-part Phase 1 study. Each part enrolled 40 participants. In the single-ascending dose portion of the study, in which a group of participants received just a single dose, the 1.2 mg dose led to an average 3.8% loss in body weight that was maintained for five weeks.”
    • “Metsera said its drug’s half-life of 19 days supports once-monthly dosing. That would be an advantage over the once-weekly dosing of the GLP-1 drugs currently available and the clinical-stage amylin drugs in development by other companies, such as Novo Nordisk, Roche, and AbbVie.”

From the U.S. healthcare business front,

  • Fierce Healthcare notes,
    • “Employers are aiming to be more strategic in how they administer benefits as costs continue to rise, according to a new survey from the consulting firm WTW.
    • “WTW released its latest Benefits Trends Survey on Tuesday and found that rising benefit costs were the largest factor driving the strategy around coverage for employers. In addition, employers ranked the financial pressures on budgets as the fourth-highest factor.
    • “Close to half (44%) of those surveyed said that they faced challenges in delivering on their health benefit strategies given rising costs, with 44% saying the same about wellness programs and 36% saying they faced challenges around leave offerings.
  • and
    • “The American Medical Association underwent its annual leadership change on Tuesday, inaugurating otolaryngologist Bobby Mukkamala, M.D. as the 180th president of the nation’s largest physician association. 
    • “The organization’s House of Delegates, composed of its member physicians and residents, also chose urologic surgeon William Underwood III, M.D., as its president-elect. Underwood will assume the presidency in June 2026. 
    • “Mukkamala is a Flint, Michigan-based physician who attended the University of Michigan Medical School and completed his residency at Loyola University Medical Center in Chicago. Mukkamala said in an interview with Fierce Healthcare in June 2024 that he hopes to work on prevention of chronic diseases rather than the “sick care” model that costs the health system millions.
    • “He will also continue the heavy-hitting physician group’s advocacy on increasing physician pay and easing the burden of prior authorization, two top concerns for physicians.” * * *
    • “Underwood, the new president-elect, has spent his 25-year career in Buffalo, New York as a urologic surgeon and doing robotic urologic surgery. He holds patents for discovering a biomarker in prostate cancer and has co-authored nearly 120 peer-reviewed publications, book chapters and published abstracts.” * * *
    • “It is an incredible honor to be chosen by my peers to represent physicians and the patients we serve at this critical moment for health care and medicine,” Underwood said in a statement. “The AMA is leading the way in fighting for a rational Medicare payment system, to rein in prior authorization, and reduce physician burnout. I will stand up to advocate for our profession in a way that will inspire, motivate, and activate physicians to join the AMA in our efforts to improve the health of our nation.”
  • Modern Healthcare reports,
    • “Mayo Clinic is investing in an ambient clinical artificial intelligence startup, the health system said Tuesday.
    • “The Rochester, Minnesota-based health system made an undisclosed investment and entered into a collaboration focused on ambient clinical intelligence with Hellocare.ai, a healthcare artificial intelligence and virtual care company.
    • “Mayo becomes the fourth major health system to invest in Hellocare.ai since April. The investment is an extension of Hellocare.ai’s $47 million Series A funding round that included support from a group of health systems including Cincinnati-based Bon Secours Mercy Health, Aurora, Colorado-based UCHealth, OSF Ventures, the corporate investment arm of OSF HealthCare.
    • “Hellocare has developed an AI-enabled software and hardware platform for hospitals and health systems featuring cameras and microphones mounted on patient room televisions to assist clinical staff with tasks such as ambient documentation and patient monitoring. The company also offers a virtual care solution that supports clinicians with rounds, medication checks and patient discharge.”
  • and
    • “Abbott and Tandem Diabetes Care announced Tuesday an agreement to combine Abbott’s upcoming dual glucose-ketone sensor with Tandem’s insulin delivery systems to create integrated diabetes solutions.
    • “The sensor is in development, but once it’s commercially available, it will be able to detect an early rise in ketone levels to help patients avoid diabetic ketoacidosis. The company expects the sensor to be available next year, according to a spokesperson.”
  • Per Beckers Hospital Review,
    • “Cleveland-based University Hospitals recorded a $49.7 million operating loss (-3% operating margin) in the first quarter of 2025, an improvement from a $74.6 million operating loss (-4.9% margin), according to its June 10 financial report.  
    • “The system reported total operating revenue of $1.7 billion for the three months ended March  31, a 9.7% increase year over year. University Hospitals said that revenue growth was driven by a $106 million increase in net patient service revenue. 
    • “Total operating expenses increased 7.6% year over year to $1.7 billion. The growth was primarily driven by increased labor costs and patient care supplies of $39 million and $51 million, respectively.

Tuesday Report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, Rx coverage, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.
  • This afternoon, the House of Representatives passed by voice vote the Esophageal Cancer Awareness Act, HR 3490.
    • “This bill requires the Government Accountability Office to report to Congress on (1) the impact of esophageal cancer-related health care spending under the Federal Employees Health Benefits Program (FEHBP) for federal employees and retirees diagnosed with esophageal cancer, and (2) how often FEHBP participants with a high risk of esophageal cancer undergo screenings according to established guidelines.” 
    • The bill honors the late Rep. Gerald Connelly (D VA) who died from the disease. The bill now heads to Senate.
  • The New York Times reports,
    • “President Trump on Tuesday ratcheted up pressure on Senate Republicans to quickly embrace and pass legislation carrying his domestic agenda, intensifying a battle inside the G.O.P. about what should be in the measure and how much it should cost.”
  • Govexec adds,
    • “The Trump administration plans to send its first spending cuts request to Congress on Tuesday, asking lawmakers to swiftly eliminate $9.4 billion in funding for the Corporation for Public Broadcasting and various foreign aid programs.
    • “The request for what are called rescissions allows the White House budget office to legally freeze spending on those accounts for 45 days while the Republican-controlled Congress debates whether to approve the recommendation in full or in part, or to ignore it.
    • “The proposal calls on lawmakers to eliminate $1.1 billion from the Corporation for Public Broadcasting, which provides funding for National Public Radio and the Public Broadcasting Service. That means NPR and PBS would lose their already approved federal allocations, if the request is approved by Congress.”
  • Fierce Healthcare points out,
    • “The Centers for Medicare and Medicaid Services plans to undertake several new health tech initiatives, senior leaders announced today at a closed meeting with stakeholders. 
    • “The Department of Health and Human Services held a meeting today to discuss health tech policy and its recent request for information on health tech initiatives. CMS seems to be moving ahead with some of the initiatives it asked stakeholders to provide feedback on in its RFI — among them a national provider directory and modern identity verification for Medicare beneficiaries.
    • “This comes as the HHS’ health IT office announced a new leader this morning, Thomas Keane, M.D. Keane spoke at the meeting of stakeholders today at the Hubert H. Humphrey building in Washington, D.C.” 
  • Healthcare Dive adds,
    • Thomas Keane, a software engineer and interventional radiologist, began his role as national coordinator [for health information technology] Monday, the spokesperson said. He previously worked at the ASTP and served as a senior advisor to the deputy secretary of the HHS, according to his biography on the agency’s website. 
  • Healthcare Dive also relates,
    • “The Trump administration rescinded guidance on Tuesday directing hospitals to perform abortions during medical emergencies, even in states with restrictive abortion bans. 
    • “The Biden administration published the guidance in 2022, shortly after Roe v. Wade was overturned, asserting doctors were required to perform emergency care, even if that included abortions, under the Emergency Medical Treatment and Labor Act. * * *
    • “The CMS now says that guidance “does not reflect the policy of this Administration.” The new guidance is effective May 29, and furthers an executive order from President Donald Trump seeking to remove regulatory red tape, the CMS said.” * * *
    • “Texas and Idaho, which have some of the nation’s most restrictive abortion bans, have repeatedly argued that there is no conflict between EMTALA and their policies, because both states allow abortion when the mother’s life is at risk.”

From the judicial front,

  • Modern Healthcare reports,
    • “A federal district court judge on Tuesday denied motions to dismiss complaints in two lawsuits against data analytics firm MultiPlan — now operating as Claritev — and a number of insurers.
    • “Judge Matthew Kennelly of the U.S. District Court for the Northern District of Illinois denied Claritev’s motion to dismiss complaints in two lawsuits involving federal and state antitrust and consumer protection claims.” * * *
    • “Both lawsuits allege Claritev colluded with insurers to reduce pay for out-of-network providers, violating state and federal antitrust laws under the Sherman Act.
    • “We remain confident in the strength of our legal position and look forward to presenting the facts as the case moves forward,” Claritev said in a statement Tuesday. “These lawsuits will only serve to increase healthcare cost for employers and patients. We will vigorously defend ourselves through the legal process while remaining focused on delivering value to our customers and the broader healthcare ecosystem.”
  • Per Healthcare Dive,
    • “Centene is being sued for wrongful death after one of its members died after failing to get the mental healthcare he needed because of the insurer’s inadequate provider networks, according to the lawsuit filed by the member’s mother.
    • “The suit, filed late May in the Superior Court of Maricopa County in Arizona, accuses Centene’s subsidiary in the state, Health Net, of maintaining “ghost networks” — wherein insurers say providers are in network that aren’t, inflating the care options available under their plans to the detriment of actual access.
    • “As a result, Centene violated state and federal laws requiring network accuracy and adequacy, according to the suit, which also accuses the St. Louis-based payer of negligence and fraud. Centene did not respond to a request for comment.”
  • Per MedTech Dive,
    • “The Food and Drug Administration did not appeal a recent U.S. District Court decision that set aside the agency’s final rule aimed at increasing its authority over laboratory developed tests, according to two lab industry groups.
    • “The 60-day window for the FDA to appeal the ruling by the U.S. District Court for the Eastern District of Texas expired over the weekend. The Association for Molecular Pathology supported the FDA’s move not to appeal.
    • “This decision should finally conclude the FDA’s unwarranted and overreaching attempts to assert regulatory authority over LDTs,” AMP President Jane Gibson said in an emailed statement.”

News from the American Society of Clinical Oncology’s conference

  • The New York Times reports,
    • “A group of 97 patients had longstanding multiple myeloma, a common blood cancer that doctors consider incurable, and faced a certain, and extremely painful, death within about a year.
    • “They had gone through a series of treatments, each of which controlled their disease for a while. But then it came back, as it always does. They reached the stage where they had no more options and were facing hospice.
    • “They all got immunotherapy, in a study that was a last-ditch effort.
    • “A third responded so well that they got what seems to be an astonishing reprieve. The immunotherapy developed by Legend Biotech, a company founded in China, seems to have made their cancer disappear. And after five years, it still has not returned in those patients — a result never before seen in this disease.
    • “These results, in patients whose situation had seemed hopeless, has led some battle-worn American oncologists to dare to say the words “potential cure.”
    • “The new study, reported Tuesday at the annual conference of the American Society of Clinical Oncology and published in The Journal of Clinical Oncology, was funded by Johnson & Johnson, which has an exclusive licensing agreement with Legend Biotech.”
  • Per Fierce Pharma,
    • “Though they are both multiple myeloma drugs with the same mechanism of action, Sanofi’s Sarclisa has had difficulty competing with Johnson & Johnson’s powerhouse Darzalex, largely because it reached the market five years later.
    • “But one advancement that could help Sanofi close some of the gap is its on-body delivery system for its CD38 antibody.
    • “Tuesday, at the American Society of Clinical Oncology annual meeting in Chicago, Sanofi presented data from two trials that showed Sarclisa administered subcutaneously (SC) from an investigational on-body injector (OBI) reduced treatment time and produced similar efficacy and safety compared to intravenous (IV) infusion.”
  • Per BioPharma Dive,
    • “An experimental, non-hormonal drug from Bayer can reduce the hot flashes and other menopausal side effects many women taking a common breast cancer therapy experience, according to results from a late-stage clinical trial run by the pharmaceutical company.
    • “The study, known as Oasis-4, is the fourth successful trial test of Bayer’s drug, called elinzanetant. Detailed data presented at the American Society of Clinical Oncology’s annual meeting Monday showed treatment reduced vasomotor symptoms in women receiving endocrine therapy to treat or prevent hormone receptor-positive breast cancer.”
  • and
    • “A Johnson & Johnson drug currently used for advanced prostate cancer can help keep the disease from progressing in men who are at earlier stages and have certain genetic mutations, according to newly unveiled data from a Phase 3 clinical trial.
    • “Results from this trial, named Amplitude, were released Tuesday at the American Society of Clinical Oncology’s meeting in Chicago. They could potentially expand the number of people able to receive J&J’s Akeega, a pill that combines the active ingredients from the medicines Zejula and Zytiga.”
  • The Wall Street Journal reports,
    • “Roche said Tecentriq combined with lurbinectedin shows significant survival benefits for patients with extensive-stage small cell lung cancer.
    • “The Swiss pharmaceutical company said Tuesday that late-stage trials showed the combination led to a 46% reduction in the risk of the disease progressing or death, and 27% reduction in the risk of death.
    • “The combination can be used a as a first-line maintenance treatment for people with the cancer following induction therapy with carboplatin, etoposide and Tecentriq, it said.
    • “The safety profile of the combination was consistent with the known safety profiles of Tecentriq and lurbinectedin, Roche said.”

In other medical research and public health news,

  • Cigna, writing in LinkedIn, explains why early detection is so important to fighting breast cancer.
  • The latest issue of the National Institutes of Health’s Research Matter covers “Customized gene therapy | Parents with substance use disorders | Ultra-processed food consumption.”
  • The New York Times discusses “Anorexia in Middle Age and Beyond. A growing number of older women are seeking treatment for eating disorders. Many have struggled without help for decades.”
  • MedCity News informs us,
    • “The World Health Organization estimates that about 10% of women and girls of reproductive age around the world — roughly 190 million people — suffer from chronic pain as a result of endometriosis. 
    • “Take this estimate with a grain of salt, though — it’s likely too low. The average diagnostic delay for endometriosis patients is eight years, driven in large part by the fact that the standard method used to diagnose the disease is an invasive surgical procedure.”
    • Boston-based biotech startup Heranova Lifesciences is working to address this problem by developing a non-invasive blood-based test. Just this spring, the company announced the LDT validation and U.S. launch of this product, which is called HerResolve. * * *
    • “The gold standard that doctors use to diagnose endometriosis is laparoscopy followed by histological confirmation. With this method, doctors put patients under anesthesia and perform a laparoscopy to look at the tissue and lesions growing outside the uterus — then, the doctor takes a tissue sample to confirm the diagnosis under a microscope.
    • “This method of testing is invasive — and not very quick. Heranova’s test seeks to address these issues by using machine learning to analyze a panel of biomarkers in a patient’s blood sample to determine whether or not they have endometriosis. 
    • “The test’s accuracy is on par with laparoscopy followed by histopathology, said Farideh Bischoff, Heranova’s chief medical officer.”
  • Per Health Day,
    • “Clinicians consider administration of human papillomavirus (HPV) vaccine as feasible at age 9 to 10 years, and parents appear to be receptive to discussing vaccination at this age, according to a study published online June 2 in Pediatrics.
    • “Caroline K. Tietbohl, Ph.D., from the University of Colorado and Children’s Hospital Colorado in Aurora, and colleagues conducted an explanatory sequential mixed-methods study as part of an ongoing randomized trial that compared initiation at ages 9 to 10 years (intervention) versus 11 to 12 years (control) across 17 practices in Colorado (nine intervention) and 16 practices in California (eight intervention). At one month after study initiation, practice clinicians were surveyed, and semi structured interviews were conducted at three months after study initiation.” * * *
    • “The results of our prospective trial will determine if initiating vaccination earlier increases vaccination completion rates, especially by age 13 years,” the authors write.
  • The Wall Street Journal reports,
    • People are more likely to get cancer as they age. Dr. Miriam Merad has an unconventional idea of how that might be reversed: using allergy drugs and other seemingly unlikely medications to damp a condition known as “inflammaging.”
    • The immunologist and oncologist has spent years examining malignant tumors to learn why people over age 50 account for nine in 10 cancer diagnoses in the U.S. She and her research team at the Icahn School of Medicine at Mount Sinai in New York City have homed in on an answer: the aging immune system. Their studies of individual immune cells in human lung tumors, as well as in old mice, have revealed how chronic, or pathogenic, inflammation in older people—dubbed inflammaging—interferes with the immune system and fuels cancer growth.
    • Merad and other researchers are testing whether existing anti-inflammatory medications usually used to fight rheumatoid arthritis or allergy conditions like asthma or eczema can slow cancer in older patients. They are also searching for new drugs. “Aging is something that we think we can transform,” says Merad, director of the Marc and Jennifer Lipschultz Precision Immunology Institute at Mount Sinai.”

From the U.S. healthcare business front,

  • Becker Payer Issues lets us know,
    • “Following a tumultuous period for UnitedHealth Group, new CEO and board chair Stephen Hemsley addressed investors on June 2, acknowledging the company’s recent shortcomings and detailing his plan to restore the high performance that investors and customers expect moving forward.
    • “Mr. Hemsley expressed a deep commitment to regaining trust through increased transparency, improved pricing strategies, and a renewed focus on internal operations, particularly at Optum Health and UnitedHealthcare. 
    • “We are well aware we have not fulfilled your expectations or our own,” he said. “We apologize for that performance and we are humbly determined to earn back your trust and your confidence.”
    • The article also provides eight notes on Mr. Hemsley’s talk.
  • STAT News adds,
    • UnitedHealth Group’s new CEO told investors that the company is reevaluating how it tallies Medicare Advantage patients’ diagnoses for reimbursement purposes, an issue currently under investigation by the Justice Department. 
    • Stephen Hemsley’s remarks during the company’s annual shareholder meeting on Monday signal a noteworthy shift: UnitedHealth is now publicly acknowledging potential issues with how it assesses the health of its Medicare Advantage members.” * * *
    • “Our management team has been working with urgency through a comprehensive and methodical review of our operations from end to end,” Hemsley said. “Digging into every part of the organization to evaluate how we have been performing and to improve that performance.”
  • Fierce Pharma notes,
    • “Medicare Part D beneficiaries can now tap into Amazon Pharmacy’s PillPack for pre-sorted medication packets, the retail giant announced on Tuesday.
    • “PillPack sorts a patient’s medications into personalized, tear-away packets that are labeled by date and time, which can make it easier to follow prescribed regimens. The expansion brings this service to more than 50 million Part D enrollees who take daily medications, Amazon said.
    • “Once eligible customers sign up for packets through PillPack, Amazon Pharmacy will coordinate needed refills to ensure prescriptions arrive on time.
    • “In addition to growing its reach in the Part D market, Amazon announced that it will roll out new services to support caregivers in managing medications for a family member or loved one.”
  • Modern Healthcare reports,
    • “Pyx Health, a digital mental health platform, on Tuesday announced its acquisition of FarmboxRx, a company that provides fresh produce food boxes to Medicare and Medicaid members.”
  • Beckers Hospital Review informs us that “Hospitals [are] push[ing] back on low Leapfrog grades.”
  • Per Fierce Healthcare,
    • “In January, H1 picked up provider data management software company Ribbon Health to broaden its reach into the health plan, provider system and digital health sectors.
    • “Five months later, the healthcare tech company has acquired Veda Data Solutions to build out its provider data and automation solutions for payers.
    • “Financial terms of the deal were not disclosed.
    • “Founded 10 years ago, Veda fixes bad provider data for healthcare organizations. Inaccurate and out-of-date health plan provider directories continue to be a thorny problem in healthcare and can make it difficult for patients to find a clinician when they need care.”

Tuesday Report

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

From Washington, DC

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

In Food and Drug Administration News,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Report

David Ermer–ACA, AHRQ, CDC, CMS, Congress, FDA, HSA, Medical / Rx research, Medicare, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The Senate has adjourned until next Monday with no sign of when the President’s nominee for OPM Director Scott Kupor will receive floor consideration. According to the Senate Executive Calendar, there are many nominees besides Mr. Kupor patiently waiting their turn.
  • Federal News Network offers an article about Wednesday’s House Oversight Committee markup and passage of its budget resolution.
  • Per a Senate press release,
    • “Today, U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, applauded the U.S. Department of Health and Human Services (HHS) and the National Institutes for Health (NIH) announcement of Generation Gold Standard, a new initiative to pursue a universal vaccine platform for viruses that are most likely to cause pandemics. HHS Secretary Kennedy and NIH Director Bhattacharya announced the initiative to protect people against multiple strains of widely contagious viruses through a beta-propiolactone (BPL)-inactivated, whole-virus platform.  
    • “Scientists have long considered universal vaccines as the Holy Grail solution to protect Americans from quickly mutating viruses,” said Dr. Cassidy. “I am glad that Secretary Kennedy and the Trump administration are prioritizing this important area of research so we can be better prepared to tackle tomorrow’s health threats.”
    • “According to HHS, the clinical trials for universal influenza vaccines are scheduled to begin in 2026, with Food and Drug Administration (FDA) approval targeted for 2029. The intranasal BPL-1357 flu vaccine, currently in advanced trials, is also on track for FDA review by 2029.”  
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services, through the Office of the Assistant Secretary for Health and Office of Population Affairs, released a comprehensive review, opens in a new tab of the evidence and best practices for promoting the health of children and adolescents with gender dysphoria. This review, informed by an evidence-based medicine approach, reveals serious concerns about medical interventions, such as puberty blockers, cross-sex hormones, and surgeries, that attempt to transition children and adolescents away from their sex.
    • “The review highlights a growing body of evidence pointing to significant risks—including irreversible harms such as infertility—while finding very weak evidence of benefit. That weakness has been a consistent finding of systematic reviews of evidence around the world.
    • “The review also fills a gap in the medical literature and existing clinical practice reviews with regard to the ethical aspects of pediatric medical transition. HHS believes that medical ethics should be central in this debate.”
  • The Internal Revenue Service announced
    • SECTION 2. 2026 INFLATION ADJUSTED ITEMS
      • “.01 Health Savings Account Inflation Adjusted Items.
        • “(1) Annual contribution limitation. For calendar year 2026, the annual limitation on deductions under § 223(b)(2)(A) for an individual with self-only coverage under a high– deductible health plan is $4,400. For calendar year 2026, the annual limitation on deductions under § 223(b)(2)(B) for an individual with family coverage under a high deductible health plan is $8,750.
        • “(2) High deductible health plan. For calendar year 2026, a “high deductible health plan” is defined under § 223(c)(2)(A) as a health plan with an annual deductible that is not less than $1,700 for self-only coverage or $3,400 for family coverage, and for which the annual out-of-pocket expenses (deductibles, co-payments, and other amounts, but not premiums) do not exceed $8,500 for self-only coverage or $17,000 for family coverage.”
  • OPM proposed a new rule
    • “The Office of Personnel Management (OPM) is proposing to remove the prohibition of a forced distribution of performance rating levels within the Senior Executive Service (SES) as well as eliminate diversity, equity, and inclusion (DEI) language within SES performance management regulations. Currently, agencies are prohibited from establishing quotas or limits on the number or proportion of the various rating levels assigned, meaning that each senior executive potentially can receive any rating based on their performance, irrespective of how other senior executives perform within the agency. However, governmentwide SES ratings data have consistently shown that virtually all SES receive the highest rating levels (i.e., levels 4 and 5) despite documented reports of SES failings. Removing the prohibition on forced distribution would allow agencies to establish and enforce limits on the highest SES rating levels, thereby increasing rigor in the SES appraisal process and leading to a more normalized distribution of SES ratings across the Federal Government.”
    • The FEHBlog estimates that the public comment period will end on June 2, 2025.
  • Tammy Flanagan, writing in Govexec, provides “a crash course in retirement planning. Let’s revisit my tips and resources for transitioning from employee to annuitant.”
  • Fierce Healthcare lets us know,
    • The Centers for Medicare & Medicaid Services (CMS) has launched the Fraud Detection Operation Center (FDOC) to fight waste, fraud and abuse, the agency announced this week.
    • Listed on a new webpage are a list of “recent success stories.” They include taking action against improper enrollment in Affordable Care Act (ACA) plans, cracking down on false billing of wound care services and scrutinizing “problematic activities” regarding hospice claims.
    • The page also claims it stopped payments to a provider who died 20 years ago as well removed 18 providers convicted of a “serious crime” for not meeting adequate standards.” ***
    • “The FDOC leverages the Fraud Prevention System (FPS), a system developed, built and operated by federal contractor Peraton. The FPS uses artificial intelligence and machine learning models to flag potentially fraudulent behavior by providers, allowing investigators to more easily see whether a provider should be funneled to the government’s case management system.”

From the Food and Drug Administration front,

  • Fierce Pharma tells us,
    • “Amid a slew of recent shake-ups at the FDA—including the agency’s reduction in force and high-profile leadership exits—the regulator is ushering in “radical” changes to how it signs off on new vaccines.
    • “Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure—a radical departure from past practices,” the Department of Health and Human Services (HHS) said in a statement to CNN. 
    • “It isn’t immediately clear which “new” vaccines will be affected by the policy. Flu and COVID-19 vaccine shots are updated annually to match the latest strains and variants, so manufacturers do indeed roll out new shots based on their existing platforms. For novel vaccines against completely new viral targets, placebo testing is a regular part of the R&D and regulatory review process.” * * *
  • Per BioPharma Dive,
    • “The Food and Drug Administration has asked Moderna for additional data before it will consider approving a combination shot the company developed for flu and COVID-19, the latest sign vaccines may face additional regulatory scrutiny under new agency leadership.
    • “Alongside first quarter earnings Thursday, the biotechnology company said a U.S. approval decision previously expected this year may now occur in 2026. Moderna filed for approval in 2024 based on a late-stage study showing the shot sparked immune responses against both viruses in adults 50 years of age or older. But the FDA has communicated that it will require Phase 3 flu efficacy data before issuing a clearance, Moderna said.”

From the judicial front,

  • Healthcare Dive reports,
    • “The Department of Justice is accusing three of the largest health insurers in the U.S. of paying brokers kickbacks for enrolling seniors in their Medicare Advantage plans.
    • “CVS unit Aetna, Elevance and Humana paid brokers eHealth, GoHealth and SelectQuote hundreds of millions of dollars in return for signing people up for their MA coverage from 2016 to 2021 — regardless of the plans’ suitability for those members’ needs, according to the DOJ’s complaint filed Thursday.
    • “Spokespeople for Humana and CVS said the companies are reviewing the DOJ’s complaint and did not provide detailed comment for this story, though CVS said it disagrees with the allegations. Elevance did not respond to a request for comment.”

From the public health and medical research front,

  • CBS News reports,
    • “Diabetes deaths in the U.S. have fallen to some of the lowest rates in years, according to new preliminary figures published by the Centers for Disease Control and Prevention, reversing a surge in mortality that was seen during the COVID-19 pandemic.
    • “There were 26.4 deaths per 100,000 people from diabetes, according to early death certificate data for the third quarter of 2024 published this month by the CDC’s National Center for Health Statistics. 
    • “Death rates from diabetes peaked in 2021, according to CDC figures, at 31.1 deaths per 100,000 people for that year. Diabetes was the eighth leading cause of death in 2021. The CDC says the link between COVID-19 and diabetes may be to blame for that increase. 
    • “Data show an increase in mortality rates for all people during the COVID-19 pandemic, and research shows that people with underlying conditions, including diabetes, are more likely to become very sick from COVID-19 and have a higher risk of hospitalization and death,” Christopher Holliday, head of the CDC’s Division of Diabetes Translation, told CBS News in a statement.
    • “Holliday added that research shows the pandemic may also have made it harder for Americans to properly manage the disease, ranging from interruptions to physical activity to disruptions to routine medical care diagnosing and treating the disease.”
  • MedPage Today adds,
    • While the incidence of breast cancer in young women has been increasing over the last 20 years, breast cancer deaths in this age group fell significantly between 2010 and 2020, researchers found.
    • Among women ages 20 to 49, incidence-based mortality declined from 9.70 per 100,000 women in 2010 to 1.47 per 100,000 in 2020, reported Adetunji Toriola, MD, PhD, MPH, of the Siteman Cancer Center at the Washington University School of Medicine in St. Louis, at the American Association for Cancer Research annual meeting in Chicago.” * * *
    • “While breast cancer mortality declined for each racial/ethnic group, rates differed substantially between groups.
    • “Black women had the highest incidence-based mortality in 2010 (16.56 per 100,000), and while that rate declined significantly over the next decade, these women still had the highest incidence-based mortality rate in 2020 (3.41 per 100,000).
    • “White women had the lowest incidence-based mortality in 2010 (9.18 per 100,000) and 2020 (1.16 per 100,000).
    • “Moreover, 5-year relative survival rates by race/ethnic group showed that rates exceeded 88.7% for most groups, except for Black women (82.4%). That discrepancy was similar for 10-year relative survival rates.
    • “There were significant declines in mortality among women aged 20 to 49 with breast cancer,” Toriola said during a press briefing. “However, there are still opportunities for improvements, especially in relation to eliminating disparities in survival.”
  • HCPLive informs us,
    • The burden of chronic kidney disease (CKD) attributable to physical inactivity increased significantly from 1990-2021, according to findings from a recent study
    • Leveraging data from the Global Burden of Disease (GBD) 2021, the study found that despite some regional declines in mortality rates, global CKD-related deaths and disability-adjusted life years (DALYs) have risen significantly, especially in low-sociodemographic index (SDI) regions, among older adults, and in females.1
    • “In recent years, low physical activity has become a major risk factor for noncommunicable diseases, contributing to the increased incidence of various chronic conditions, including diabetes, cardiovascular diseases, and CKD,” ZhenYi Zhao, of the School of Competitive Sports at Beijing Sport University in China, and colleagues wrote.
  • Per an NIH news release,
    • “The genes of male and female placentas have marked differences in how they are expressed, according to a study by researchers at the National Institutes of Health (NIH) and other institutions. These differences involve the presence or absence of tags on DNA known as methyl groups, which switch genes on or off without changing their structure. Understanding these DNA methylation patterns may inform future research on the higher risk for pregnancy complications involving male fetuses, such as stillbirth and prematurity, as well as later life health conditions that occur in adults who were born after a complicated pregnancy.”
  • The New York Times reports,
    • The happiness curve is collapsing.
    • For decades, research showed that the way people experienced happiness across their lifetimes looked like a U-shaped curve. Happiness tended to be high when they were young, then dipped in midlife, only to rise again as they grew old.
    • But recent surveys suggest that young adults aren’t as happy as they used to be, and that U-shaped curve is starting to flatten.
    • This pattern has shown up yet again in a new study, one of a collection of papers published on Wednesday in the journal Nature Mental Health. They are the first publications based on the inaugural wave of data from the Global Flourishing Study, a collaboration between researchers at Harvard and Baylor University.” * * *
    • “The study participants had relatively low measures of flourishing on average until age 50, the study found. This was the case in a number of countries, including the United Kingdom, Brazil and Australia. But the difference between the younger and older adults was largest in the United States, the researchers said.
    • “It is a pretty stark picture,” said Tyler J. VanderWeele, the lead author of the study and director of Harvard’s Human Flourishing Program. The findings raise an important question, he said: “Are we sufficiently investing in the well-being of youth?”
  • Healio relates,
    • “Individuals using e-cigarettes exclusively had a significantly elevated risk for COPD, whereas this was not found when assessing the risk for type 2 diabetes or heart failure, according to data published in Nicotine and Tobacco Research.
    • “For clinicians, these results offer helpful information about how e-cigarettes compare to regular cigarettes in terms of health risks,” John Erhabor, MD, MPH,research postdoctoral fellow at Johns Hopkins Medicine, told Healio. “While e-cigarettes may have fewer heart and metabolic risks than regular cigarettes, they are still tied to certain problems like COPD and possibly high blood pressure in some age groups.
    • “Doctors should take these differences into account when advising patients and make clear that switching completely from regular cigarettes to e-cigarettes may potentially lower health risks, but using both does not offer the same benefit,” Erhabor said.”
  • The American Medical Association News points out,
    • “The Health Resources and Services Administration announced its toll-free number (1-833-TLC-MAMA) and promotional toolkit are available in advance of Maternal Mental Health Awareness Week, May 5-11. Since its launch on Mother’s Day 2022, the hotline has received more than 54,173 calls and texts from individuals seeking help for themselves (73%) or on behalf of someone else (4%). The hotline is available in English and Spanish and offers interpreters in more than 60 languages.”
  • The U.S. Preventive Services Task Force released a final research plan for “Sexually Transmitted Infections: Behavioral Counseling.” The next step is a proposed recommendation.
  • STAT New warns,
    • The era of “tranq” may be ending.
    • “But tranq, as the powerful veterinary tranquilizer xylazine is known in the illicit drug supply, is being replaced at least in part by a dangerous new sedative: medetomidine. In the past year, the anesthetic has become an increasingly common element in the drug supply, with cities and states including Philadelphia, Pittsburgh, Chicago, and San Francisco reporting cases of medetomidine-involved overdoses.
    • “In Philadelphia in particular, reports of medetomidine have skyrocketed. When the city first began testing for the substance in May 2024, it found medetomidine in 29% of fentanyl samples analyzed, according to data from the city’s public health department. Six months later, medetomidine’s prevalence had increased threefold to 87% — while xylazine’s dropped from 100% early in the year to 42% in November.”
  • The CDC adds in a related report issued today,
    • Summary
    • What is already known about this topic?
      • Medetomidine is an increasingly common adulterant of illegally manufactured opioids.
    • What is added by this report?
      • During October 2024–March 2025, a total of 23 adult patients who used illegally manufactured opioids sought treatment within a health care system in Pittsburgh, Pennsylvania. All exhibited severe autonomic hyperactivity, and most required dexmedetomidine infusion and intensive care unit–level management. Medetomidine metabolites were detected in all 10 patients for whom retrospective analysis was performed, despite only two having detectable parent compound (medetomidine) on comprehensive urine drug screening.
    • What are the implications for public health practice?
      • Health care providers in regions where medetomidine has been detected in the drug supply should be prepared to manage a severe withdrawal syndrome among patients who use illegally manufactured opioids, even if drug testing for medetomidine is negative.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “CVS Health’s insurance division Aetna will stop offering plans for individuals on the Affordable Care Act exchanges in 2026, after the company projected big losses in the business this year.
    • “The news was announced in tandem with CVS’ first quarter results, which exceeded investor expectations and represent a turnaround for CVS’ beleaguered insurance business, analysts said. The Rhode Island-based healthcare company reported net profit of $1.8 billion — up 60% year over year — on revenue of $94.6 billion.
    • “CVS’ pharmacy benefit manager Caremark also reached an agreement with Danish drugmaker Novo Nordisk to give its weight loss drug Wegovy preferred access on Caremark’s standard formulary, which covers tens of millions of Americans. The deal should increase access to Wegovy at the expense of other therapies, such as Eli Lilly’s Zepbound.”
  • Fierce Pharma notes,
    • “Moderna is extending its cost savings program into 2027 and targeting a cash breakeven point sometime in 2028 as the larger U.S. vaccine market faces new uncertainties under the Trump administration.
    • “Moderna aims to reduce its GAAP operating costs by 1.4 billion to $1.7 billion between 2025 and 2027, the company announced Wednesday. The Massachusetts biotech now targets $4.7 billion to $5 billion in GAAP costs in 2027, versus $7.2 billion last year.
    • “On a Thursday conference call with investors, Moderna CFO Jamey Mock outlined a roadmap for the mRNA specialist to lower its cash operating costs from about $6.3 billion in 2024 to about $5.5 billion this year, and then further to $4.7 billion and $4.2 billion in the two subsequent years.
    • “Compared with cash operating costs, GAAP costs also include stock-based compensation for executives and asset value depreciation.”
  • The Leapfrog Group released its Spring 2025 hospital patient safety grades today.
  • Per MedTech Dive,
    • “GE Healthcare cut its 2025 adjusted earnings outlook to reflect an estimated 85-cent-per-share impact from tariffs, especially duties affecting trade with China, executives said on an earnings call Wednesday.
    • “CEO Peter Arduini said bilateral U.S. and China tariffs account for 75% of the total net impact.
    • “For the full year, GE Healthcare now expects adjusted earnings in a range of $3.90 to $4.10 per share, down from the prior estimate of $4.61 to $4.75.
    • “The revised outlook assumes that tariffs remain at the current elevated levels and that U.S. reciprocal tariffs on the rest of the world — announced April 2 — return to pre-pause rates on July 9. The forecast also assumes Mexico and Canada tariffs remain in place, with exemptions under the U.S.-Mexico-Canada Agreement continuing for all eligible imports.”
  • and
    • “Abbott has struck a deal to integrate data from its Libre continuous glucose monitors into Epic’s electronic health record systems in the U.S., the companies said Tuesday.
    • “The integration will connect Abbott’s data management software to Epic’s EHR systems. Linking the systems will allow clinicians to view glucose data captured by Libre devices within Epic. 
    • “The Epic integration could be the start of a broader Abbott initiative. Lisa Earnhardt, group president of medical devices for Abbott, said in a statement that the company aims to expand the integrated model to “other medical devices and connected care platforms in the future.”
  • Modern Healthcare reports,
    • “Medical weighing and measuring technology company seca launched the first compact, portable body composition scanner designed for primary care on Thursday.
    • “The mBCA Alpha scanner generates a detailed assessment of a patient’s body composition in 24 seconds, which includes percentages of fat, bone and muscle. Clinicians can use the information to spot early signs of excess body fat, age-related muscle decline and the impact medications like GLP-1s can have on the body, among other factors.
    • “Primary care physicians typically rely on weight and body mass indexing to determine a patient’s risk of chronic conditions such as obesity, diabetes, heart disease and metabolic syndrome. But body mass index doesn’t reflect muscle mass or fat distribution, which can vary significantly depending on age, gender and race, according to Nina Crowley, director of clinical education and partnerships at seca.
    • “The American Medical Association issued a policy update in June 2023 that called out body mass index as an imperfect way of measuring body fat in some populations and recommended it be used in conjunction with other screenings including body composition.
    • “Other imaging modalities like MRI and dual-energy X-ray absorptiometry can also provide information about a patient’s body composition, but Alpha can do it at a fraction of the cost, according to Crowley.”

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.

Midweek Report

David Ermer–CDC, COVID-19 vaccine, FDA, Government Contracting, Medical / Rx research, Medicare, Mental health care, NIH, U.S. Healthcare–

From Washington, DC,

  • Federal News Network interviews Stephanie Kostro, executive vice president for policy at the Professional Services Council about the re-write of the Federal Acquisition Regulation that the President announced in an April 16, 2025, Executive Order.
  • Federal News Network adds,
    • “After laying off employees as part of its reduction in force (RIF), the Office of Personnel Management is now circulating a handful of job announcements to impacted employees that are nearly identical to their previous roles — only in a different OPM component.
    • “In an internal email obtained by Federal News Network, OPM notified the impacted staff members on Monday of five vacancies in OPM’s Human Resources Solutions (HRS) office, which manages the software for USA Jobs, USA Staffing and other federal HR products and services.”
  • Fierce Healthcare tells us,
    • “The National Institutes of Health (NIH) will begin work on a comprehensive federal database of patient records to study autism and chronic disease, Director Jay Bhattacharya, M.D., Ph.D., announced Monday. 
    • “The commitment gives legs to Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.’s calls to find the root cause of childhood autism, which he calls an epidemic. The NIH appears poised to put federal resources to work to create a central, shareable resource for the researchers that undertake RFK Jr.’s call to action.”

From the judicial front,

  • Healthcare Dive informs us,
    • “U.S. Bankruptcy Judge Stacey Jernigan approved Prospect Medical Holdings’ plan to begin winding down operations at Crozer Health on Tuesday, after lawyers for the health system said an 18 months-long effort to find new buyers for the facilities was unsuccessful.
    • “Emergency departments at Crozer-Chester Medical Center and Taylor Hospital, both in Delaware County, Pennsylvania, are set to stop receiving patients by ambulance this week. They’ll continue to accept walk-in patients for up to a week after, according to the hospitals’ closure plan, which attorneys characterized as evolving.
    • “The closure plan faced significant pushback from county officials, nurses and nonprofits who warn that closing the facilities will force residents to travel farther for care and could risk lives.”
  • STAT News reports,
    • “Amid ongoing battles over alternate supplies of blockbuster weight loss drugs, Eli Lilly filed new lawsuits against four telehealth firms and their affiliates but is using a new line of attack — the drugmaker accused two of the companies of engaging in the corporate practice of medicine.
    • “To date, Lilly and its rival, Novo Nordisk, have filed dozens of suits against numerous companies involved in compounding versions of semaglutide and tirzepatide, the obesity and diabetes drugs known as GLP-1s. For the past three years, telehealth firms, compounding pharmacies, and med spas have partnered to manufacture, prescribe and distribute copies of the drugs while shortages existed. Those lawsuits alleged trademark infringement, false claims and unfair competition, but have so far yielded varying outcomes.
    • “This time, Lilly has alleged two companies, Mochi Health and Fella Health, engaged in the corporate practice of medicine, which refers to controlling and influencing prescribing decisions of health care providers. They purportedly did so with the help of affiliated medical groups and compounding pharmacies, according to separate lawsuits filed on Wednesday in the U.S. District Court for the Northern District of California.”

From the public health and medical research front,

  • The American Hospital Association News points out,
    • “U.S. births grew 1% in 2024 to 3.6 million, according to preliminary data from the Centers for Disease Control and Prevention. The cesarean delivery rate slightly increased to 32.4% in 2024, from 32.3% in 2023. The 2024 preterm birth rate was 10.41%, unchanged from 2023.”
  • and
    • “There have been 8,064 reported cases of whooping cough in the U.S. so far this year, according to the latest data from the Centers for Disease Control and Prevention. There were 3,835 cases at the same time in 2024.”
  • Per today’s American Medical Association’s Morning Rounds,
    • “The New York Times (4/22, Gross) reports that “neuroscientists have learned that estrogen is vital to healthy brain development but that it also contributes to conditions including multiple sclerosis and Alzheimer’s. Changes in estrogen levels – either from the menstrual cycle or external sources – can exacerbate migraines, seizures and other common neurological symptoms.” In the brain, “estrogen can bind directly to receptors within neurons and other cells, setting off a cascade of actions. It can also be broken down into metabolites, called neurosteroids, which exert their own far-reaching effects.” Researchers also know that estrogen “can modulate neuron firing, reduce inflammation, increase neuroplasticity, help turn glucose into energy, prevent plaque from building up and improve blood flow in the brain.” A recent review published in Brain Medicine suggests there are a “huge number of neurological diseases that can be affected by sex hormone fluctuations.”
  • The Wall Street Journal reports,
    • “Mounting evidence suggests that vaccination against the varicella zoster virus—which causes chickenpox in children and triggers shingles in adults—also protects the brain.  
    • “Several recent studies suggest that the vaccines reduce the risk of dementia in older adults, but key questions remain, including How the vaccines might work to stop or delay the condition, and whether the benefit is limited to people of a certain age. 
    • “The vaccines studied, Zostavax and Shingrix, both appeared to offer protection. 
    • “The latest study found that among 70- and 80-year-olds in Australia, people who were eligible to get the Zostavax shot were 1.8 percentage points less likely to get a dementia diagnosis in the next 7.4 years than those who were ineligible. The study was published in the journal JAMA Wednesday.”
  • Per a National Cancer Institute (NCI) news release,
    • “New immune-based treatments for kidney and pancreatic cancer have shown promising results in two small clinical trials. In both trials, the treatments appeared to prevent cancer from returning in patients who had successful surgery to remove their tumors.
    • “The treatments are called therapeutic cancer vaccines because they help the immune system eliminate an existing cancer. 
    • “In both trials, the treatments were made specifically for each patient based on intensive genetic analyses of their tumor samples collected during surgery. The analyses allowed the research teams to identify mutated proteins, known as neoantigens, on each patient’s cancer cells. These rogue proteins can act like an activated security alarm to the immune system, alerting it that the cancer cells are threats that should be killed. 
    • “For different reasons, however, this alarm system fails. The neoantigen-based treatments are designed to step into this breach, reinforcing to the immune system that any cells displaying these mutated proteins must be eliminated.
    • “In both studies, patients received multiple doses of their personalized treatments in the months following surgery. Giving the therapy after surgery is intended to kill any remaining cancer cells elsewhere in the body and potentially establish a small band of immune cells that can recognize and kill any cancer cells that pop up in the future.”
  • The NCI’s Cancer Information Highlights consider “Physical Activity | Dormant Cancer Cells | Young People with Advanced Cancer.”
  • Per STAT News,
    • “The young people who wanted to quit e-cigarettes didn’t necessarily think they were addicted. But they did think nicotine cravings were a problem. When they enrolled in a Massachusetts General Hospital trial, they told researchers they couldn’t study in the library or work at their desks for long before getting the urge to vape. “They really didn’t like that loss of control,” said Eden Evins, director of the Center for Addiction Medicine at Mass General.
    • “Using the oral pill varenicline in combination with behavioral counseling is the most effective way for young people to get that control back, according to the results of the study co-authored by Evins, published Wednesday in the Journal of the American Medical Association. Of participants ages 16 to 25, half of those who took varenicline for 12 weeks were able to abstain from e-cigarettes for the last month of that period, compared to 14% of the placebo group. After a total of six months, 28% of people in the varenicline group were still vape-free, compared to 7% of the placebo group.” 
  • Per Fierce Pharma,
    • “Akeso and Summit Therapeutics’ giant-killing, PD-1xVEGF bispecific antibody ivonescimab has posted another phase 3 trial win in lung cancer, this time as part of a chemotherapy combination. 
    • “An independent data monitoring committee has determined that the HARMONi-6 trial for the first-line treatment of advanced squamous non-small cell lung cancer (NSCLC) has met its primary endpoint of progression-free survival (PFS), Akeso said Tuesday.
    • “At the first pre-specified interim analysis of the 532-patient Chinese study, ivonescimab plus chemotherapy “decisively beat” BeiGene’s PD-1 inhibitor Tevimbra plus chemotherapy, Akeso said. The results—which will be presented at a medical conference later this year—were “statistically significant and clinically meaningful,” the Chinese company added.”
  • and
    • “Schizophrenia drug Cobenfy, a key component in Bristol Myers Squibb’s plan to navigate a transition period of major loss of exclusivity, has hit a phase 3 setback.
    • “Cobenfy as an adjunctive treatment to atypical antipsychotics failed to show superior efficacy versus placebo with atypicals when used in patients with inadequately controlled schizophrenia, according to results from the phase 3 Arise trial, Bristol Myers said Tuesday.
    • “The trial logged a numerical improvement, with adjunctive Cobenfy showing a 2-point reduction compared with placebo on the primary endpoint of reduction in the Positive and Negative Syndrome Scale (PANSS) total score at week 6. However, the number didn’t reach statistical significance. PANSS is a clinician-administered tool used to assess schizophrenia symptoms.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Healthcare spending continues to plague employers — but most aren’t yet taking sizable steps to curb costs.
    • “Nearly 85% of employers say surging healthcare prices are their biggest benefits challenge, according to a survey of about 1,800 plan sponsors nationwide published Wednesday from insurance brokerage and consulting company Lockton.
    • “Employers are bracing for healthcare costs to balloon 6%-8% this year, especially as workers seek more expensive specialty care.”
  • Becker Payer Issues adds,
    • “There may be a link between rising insurance premiums and increased utilization of services, particularly across the Medicare Advantage space.
    • “In its first quarter earnings report, UnitedHealth Group reduced its year-end earnings outlook amid rising use of physician and outpatient services among its Medicare Advantage membership and “unanticipated changes in the profile of Optum Health members.”
    • “One key insight that emerged from the company was a major rise in elective care activity, which was linked directly to the higher premiums faced by some of UnitedHealth’s group MA members. The company reported that among some public sector retiree groups, premiums had increased dramatically (in some cases by as much as $150 a month) from $50 to $200. Instead of disengaging from using their benefits, these members appear to have engaged more than usual.
    • “We’re seeing a significant and disproportionate increase in utilization largely within our public sector group retiree business. This population experienced the greatest year-over-year premium increases,” UnitedHealthcare CEO Tim Noel told investors. “We did assume that we would see some care activity level increases in this population, but we’re seeing far surpasses what we would have recently anticipated. And in that population as well, we are seeing more preventative care, more annual wellness visits, more in-home clinical assessments. The driver there is also really the follow-on care that results from that.”
  • Fierce Healthcare relates,
    • “Community Health Systems’ narrow first-quarter net loss landed right in line with Wall Street’s expectations, though the public for-profit hospital operator increased its net operating revenue on solid demand, according to financial results released Wednesday after market close.
    • “Even though healthcare providers are navigating significant change as our operating environment continues to evolve, we remain confident that our strategies are strengthening our operations and positioning the company for long-term success,” CEO Tim Hingtgen said in the results announcement.
    • “Net loss attributable to the company was $13 million (-$.10 per diluted share), an improvement over the $41 million loss (-$0.32) of the prior year’s first quarter—though the losses were narrower for both periods after adjustments (for impairment and loss on sale of business and related costs).
    • “Net operating revenues landed at $3.16 billion, just above expectations and a 0.6% year-over-year increase. On a same-store basis taking CHS’ recent divestitures into account, net operating revenues rose by 3.1%. Both of those came alongside a 1% decrease in total admissions and a 2.3% dip in adjusted admissions, but respective same store increases of 4% and 2.6%.”
  • MedTech Dive notes,
    • “Boston Scientific CEO Mike Mahoney told investors Wednesday the company expects an impact of about $200 million this year due to the Trump administration’s tariff policies, becoming the latest medtech company to forecast an impact of hundreds of millions of dollars.
    • “However, Boston Scientific, like others that have reported, still expects to perform well in 2025. Mahoney said Boston Scientific is “very bullish” on the year, and the firm raised its 2025 guidance from a growth range of 12.5%-14.5% on a reported basis to 15%-17%, even with the $200 million charge.”
  • Per KFF,
    • “The growing role of Medicare Advantage has been a defining feature of Medicare in recent years, with Medicare Advantage plans now covering more than half of all eligible Medicare beneficiaries. While most Medicare Advantage enrollees (and most people with Medicare overall) live in urban areas, as of 2024, most Medicare beneficiaries who live in the nation’s most rural counties are enrolled in traditional Medicare, not Medicare Advantage. This means that reliance on Medicare’s stand-alone prescription drug plans (PDPs) for coverage of the Medicare Part D prescription drug benefit is likely to be greater among Medicare beneficiaries living in the most rural parts of the country.”
  • MedPage Today lets us know,
    • “Novavax’s closely watched COVID-19 vaccine is on track for full approval after additional discussions with the FDA, the company said Wednesday.
    • “The news sent company shares soaring more than 21% in morning trading and appeared to resolve concerns that Trump administration officials might be holding up a decision on the shot.
    • “Novavax makes the nation’s only traditional protein-based COVID-19 vaccine. It is still being sold under emergency use authorization — unlike mRNA vaccines made by Pfizer and Moderna that have earned full FDA approval for certain age groups.”

Midweek Report

David Ermer–CDC, CMS, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Thought Catalog on Unsplash

From Atlanta, Georgia

  • MedPage Today brings us news from the April 15-16 ACIP meeting,
    • “Last June, CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended that all adults ages ≥75 years and adults ages 60 to 74 years who are at increased risk of severe RSV disease receive a single dose of RSV vaccine; the committee did not endorse one vaccine over another. That vote supplanted the committee’s earlier recommendation that adults ages 60 and older may receive RSV vaccination “after engaging in shared clinical decision making with their healthcare provider.”
    • Today, “[t]he ACIP voted 14-0, with one abstention, on Wednesday to recommend that high-risk patients ages 50 to 59 be vaccinated for respiratory syncytial virus (RSV) and also added a new option for meningococcal vaccination.
    • “I don’t think I can say it enough, but [we need] more studies in moderate-to-severe immunocompromised patients who are at highest risk for RSV disease,” ACIP member Mini Kamboj, MD, of Weill Cornell Medical College, in New York City, said after she voted for the recommendation. This is “a call to action,” she said.”
  • and
    • “The CDC’s vaccine advisors [also] are considering options that would narrow the recommendations for the fall COVID vaccine to only include groups at higher risk for severe illness.
    • Seasonal COVID shots are currently recommended for everyone 6 months and older, but CDC’s Lakshmi Panagiotakopoulos, MD, MPH, presented findings from a recent poll of the ACIP COVID-19 Work Group showing that 76% of its members supported a non-universal (risk-based) recommendation for the 2025-2026 respiratory virus season.
  • and
    • At its meeting on Tuesday, the [ACIP] considered whether the U.S. should move to single-dose human papillomavirus (HPV) vaccination instead of the currently recommended schedule.
    • At present, the U.S. recommends two doses of HPV vaccine if they are started before age 15, and three doses if they are started at age 15 or older, and for people who are immunocompromised. Routine vaccination starts at age 11 or 12 — though it can be started at age 9 — while catch-up vaccination is recommended through age 26. Shared clinical decision making is advised for those 27 to 45.
    • “However, global HPV vaccination schedules have shifted in recent years, with the World Health Organization recommending in 2022 a two-dose schedule for those 9 and older, with an option for a one-dose schedule for those between 9 and 20. The U.K. and Australia have adopted this schedule, too.”
  • and
    • “The number of cases reported in the ongoing measles outbreak in the southwestern U.S. is likely an undercount, according to the CDC scientist leading the response to the outbreak.
    • “We do believe there’s quite a large amount of cases that are not reported,” David Sugerman, MD, CDC’s senior scientist for the 2025 measles response, said during the Advisory Committee on Immunization Practices meeting on Tuesday.”

From the judicial front,

  • Federal News Network tells us,
    • “A federal judge on Tuesday issued a preliminary injunction that prevents the U.S. Department of Labor from requiring government contractors and grant recipients to certify they do not operate any diversity, equity and inclusion programs that run afoul of anti-discrimination laws until further order from the court.
    • “Judge Matthew Kennelly of the U.S. District Court for the Northern District of Illinois issued the ruling in response to a lawsuit filed by Chicago Women in Trades, a nonprofit dedicated to training and retaining women in skilled construction trades that receives several grants from the Department of Labor.
    • “The certification provision is a key part of President Donald Trump’s executive orders aimed at curbing DEI programs because contractors and grant recipients could be subjected to crippling financial penalties under the False Claims Act if they are found in violation of it.” * * *
    • “Kennelly had already issued a temporary restraining order against the Labor Department last month that was shorter in duration. His order is limited in scope because he declined to extend the injunction to other federal agencies beyond DOL.”
  • The American Hospital News informs us,
    • “A Minnesota state court April 15 dismissed a lawsuit filed by PhRMA challenging the state’s law protecting 340B pricing for contract pharmacy arrangements. The court ruled that the state law is not preempted by federal law, does not engage in unconstitutional extraterritorial regulation and that the law does not violate Minnesota’s Single Subject and Title Clause.
    • “The AHA filed an amicus brief in the case last year and filed others in similar cases for multiple states, in defense of those states’ 340B contract pharmacy laws.”
  • Beckers Payer Issues reports,
    • “CMS has denied an appeal from Humana to raise its 2025-star ratings, the company disclosed in an April 15 court filing. 
    • “Humana saw its Medicare Advantage star ratings drop significantly from 2024 to 2025, which will hurt the company’s 2026 revenues. Star ratings determine the bonuses CMS pays to MA plans. 
    • “Humana filed its lawsuit in October 2024 challenging the ratings in federal district court in Texas.”
  • In September 2019, WHYY, a Philadelphia PBS news outlet, reported
    • “Seventeen local defendants, including five medical professionals, are among those ensnared in a coordinated health care fraud enforcement action across Pennsylvania, New Jersey, New York, Connecticut and Washington, D.C., involving more than $800 million in loss and the distribution of over 3.25 million opioid pills in so-called pill mill clinics, the U.S. Justice Department said Thursday.”
    • A Justice Department press release states that on April 15, 2025, “a federal jury convicted a medical doctor [who was one of the medical professionals ensnared in September 2019], for his participation in conspiracies to commit health care fraud and wire fraud and to unlawfully distribute controlled substances.” Those crimes impacted FEHB plans, among other health plans.
  • Govexec points out,
    • As federal employees continue to face widespread layoffs, unions and advocacy groups on Wednesday launched a network to provide legal advice to government workers. 
    • The goal of the Rise Up: Federal Workers Legal Defense Network is to recruit attorneys to provide individual guidance to federal employees who fear losing their jobs or have already lost them. 
    • “Our network is already fighting back against illegal firings and other abuse of federal workers, but thousands of federal workers still need legal advice and representation,” according to the coalition’s website. “That means we need thousands of lawyers to help.” * * *
    • Federal employees can request legal assistance here.

In State government news,

  • STAT News reports,
    • “Arkansas Gov. Sarah Sanders has signed a first-in-the-nation law (HB 1150) that prohibits pharmacy benefit managers from operating both retail and mail-order pharmacies, a move designed to eliminate a conflict of interest that has been blamed for boosting the price of medicines and forcing independent pharmacies to close.
    • “At issue is an ongoing concern that the largest pharmacy benefit managers — which are controlled by CVS Health, Cigna, and UnitedHealth Group — favor their own pharmacy operations. Critics say that by doing so, these companies not only dominate the design of health plans for tens of millions of Americans but also distort the distribution and pricing for prescription medicines.” * * *
    • “The Arkansas bill has gone further than other states. The legislation would force the owners of the pharmacy benefit managers to make a choice — continue operating these industry middlemen or relinquish the right to run retail or mail-order pharmacies that operate in the state. By doing so, state lawmakers have argued they will reduce costs for state residents.”
  • KARK, a Little Rock television station, adds,
    • “CVS Health welcomes a good faith discussion with policy makers in Arkansas and across the country on ways to make medicine more affordable and accessible,” CVS shared in a statement. “Unfortunately, HB1150 is bad policy that accomplishes just the opposite: it will take away access to pharmacy care in local communities, hike prescription drug spending across the state by millions of dollars each year, and cost hundreds of Arkansans their jobs.”
    • “According to CVS, they have 23 pharmacies across the state. They also noted that this law will close more than 100 mail-order pharmacies in Arkansas.”

From the public health and medical research front,

  • Per BioPharma Dive, “New research kindles excitement around stem cell therapies for Parkinson’s Disease. Two studies published in Nature found stem cell-derived products can not only be safely transplanted into the brain but also show promising — albeit unproven — signs of efficacy.”
  • The National Academy of Sciences announced,
    • Oral health is an essential part of overall health, but issues around insurance coverage, workforce, and more, are leaving millions of Americans without sufficient oral health care. The @NASEM Health and Medicine Division hosted a workshop in November 2024 to address some of the barriers to care. Read a recap of the event here: https://tinyurl.com/5epd9rcs
  • Per MedCity News,
    • “Drugs have been the standard migraine treatment for decades. The severe headaches, nausea, and other problems associated with this common disorder now have a digital treatment option, a mobile app developed by prescription digital medicines startup Click Therapeutics.
    • “The FDA marketing authorization announced Tuesday permits use of the Click digital therapeutic for the prevention of episodic migraine in patients age 18 and older. Episodic migraine is defined as having fewer than 15 headache days per month. The Click migraine app, known in development as CT-132, does not replace migraine drugs. The FDA authorization covers use of the app as an adjunct to standard migraine treatments, which is how it was evaluated in clinical trials.
    • “Click’s research is based on mapping of the entire brain. The company has found faulty brain circuits implicated in many diseases, Chief Medical Officer Shaheen Lakan said in a 2023 interview. For various indications, the New York-based startup develops software that takes users through a series of tasks that have the effect of retraining and rewiring the brain over the course of weeks.”
  • Per Cancer Network
    • The incidence of pancreatic and colorectal adenocarcinoma has increased among young adults, highlighting a need for heightened awareness of this trend when evaluating younger patients with possible symptoms, according to findings from a retrospective cohort study published in JAMA Network Open.1
    • Findings from the trial revealed that a total of 275,273 patients with pancreatic adenocarcinoma were reported between 2000 and 2021, 51.8% of whom were male and 87.1% of whom were 55 years or older. An overall increasing incidence trend was noted, with the highest annual percentage change (APC) observed in those aged 15 to 34 years (4.35%; 95% CI, 2.03%-6.73%). The APC for the aforementioned age group was significantly higher than in those 55 years or older (1.74%; 95% CI, 1.59%-1.89%; P = .007) and those aged 35 to 54 years (1.54%; 95% CI, 1.18%-1.90%; P = .004).
  • Medscape lets us know,
    • “Can long-term physical activity influence mortality and biological aging? Researchers at the University of Jyväskylä in Jyväskylä, Finland, set out to answer this question and uncovered a surprising finding: Moderate physical activity had the most significant positive effect on longevity, reducing mortality by 7% over a 30-year period.
    • “Interestingly, higher levels of physical activity did not confer additional mortality benefits. The study was published in the European Journal of Epidemiology.”

From the U.S. healthcare business front,

  • Beckers Payer Issues tells us why “patient expectations will push healthcare to evolve by 2030, according to 21 payer executives.” 
  • Fierce Healthcare informs us,
    • “The Peterson Center on Healthcare released a new report that recommends policymakers narrow payment guidelines for a service they think could rocket spending in the public sector. 
    • “The costs of remote monitoring on Medicare have grown significantly in the years since the codes became available to providers, from $6.8 million in 2019 to $194.5 million in 2023. The services can be used for a host of chronic conditions that many Americans suffer from, including diabetes, hypertension and heart disease. 
    • “The Peterson Center takes issue with the increasing number of Medicare, Medicaid and Medicare Advantage patients who have been prescribed remote monitoring and the increasing amount of time their providers keep them using the technology. 
    • The report finds that chronic conditions only benefit from intense monitoring by providers for a short period of time, which varies by condition. Without additional guardrails, the report says public spending on remote monitoring could increase dramatically.
    • Under the current requirements for remote monitoring, CMS does not dictate which conditions should be monitored or for how long. Because CMS currently does not limit the amount of time that a provider can charge Medicare, Peterson calls them “forever codes.” 
    • The codes have only been in existence since 2019, but Peterson recommends policymakers steer providers towards high-value services and away from ongoing monitoring with no discernible clinical benefit.
  • Healthcare Dive notes,
    • “Ascension Health has inked a definitive agreement to acquire full ownership of a Texas hospital and its ancillary businesses from Community Health Systems for $460 million, the health system said Tuesday.
    • “Ascension Seton, a subsidiary of Ascension Texas, will purchase the remaining 80% stake in 126-bed Cedar Park Regional Medical Center. Although the system already owned a minority interest in Cedar Park, Ascension said acquiring full ownership would represent a “significant step” toward expanding medical services and care access in the Central Texas community.
    • “The deal is expected to close this summer, subject to regulatory approvals.
  • Per Modern Healthcare,
    • “The Permanente Medical Group and Northwest Permanente said Wednesday they have formed an affiliation.
    • “The medical groups will remain separate but will collaborate clinically and share innovations as part of the agreement. The groups will work together on telehealth, population health and workforce wellness, in addition to pursuing more subspecialty partnerships and scaling IT initiatives, a spokesperson said.” * * *
    • “The Permanente Medical Group and Northwest Permanente are independent, physician-led groups that partner with the Kaiser Foundation Health Plan to serve patients in Oregon, Washington and California. The Permanente Medical Group has nearly 10,000 physicians across 116 specialties, while Northwest Permanente has more than 1,300 physicians across 54 specialties. The groups collectively care for 5.2 million members.”
  • and
    • “Abbott Laboratories will make new investments in U.S. manufacturing, with the impact of tariffs on medical devices and diagnostics looming over the industry.
    • “It expects to spend $500 million on two facilities, located in Illinois and Texas, Abbott said in a statement Wednesday. The investments are to expand existing plants and boost U.S. research and development, a spokesperson said. The company will hire as many as 200 people in Illinois and as many as 100 people in Texas to support the work.”
  • Beckers Clinical Leadership relates,
    • “Mark Cuban’s latest move to disrupt the pharmaceutical supply chain is expanding — this time, tackling the injectable drug market through a new partnership with distributor Morris & Dickson.
    • “His company, Mark Cuban Cost Plus Drug Co., is partnering with Morris & Dickson, a full-line and specialty pharmaceutical distributor, to improve access to injectables nationwide. 
    • “The collaboration, announced April 14, aims to mitigate drug shortages, streamline procurement and provide equitable access to providers of all sizes. It also promotes sourcing flexibility by removing volume commitments, according to a news release.”

Monday Report

David Ermer–CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Obesity, U.S. Healthcare–
Photo by Sven Read on Unsplash
  • Paul Wolfowitz, writing in the Wall Street Journal, shares “Reflections on Lincoln 160 Years After His Murder. America’s greatest president had moral vision, strategic genius, and astounding eloquence.” RIP.
    • “Tuesday is the 160th anniversary of Abraham Lincoln’s assassination. That grim milestone invites speculation about what might have been had he lived to serve out his second term. It is also an occasion to reflect on what made Lincoln great—why his example still matters.
    • “Lincoln is the greatest American president not because he was perfect, but because he had so many leadership qualities crucial for confronting the challenges facing him. He combined moral vision with strategic genius, a rare mix for any political leader.” * * *
    • “So, I am grateful to Providence that we had a leader of Lincoln’s stature at a time of our greatest need. And so should we all be.”

From Washington, DC,

  • From an FTC news release,
    • “Today, the Federal Trade Commission launched a public inquiry into the impact of federal regulations on competition, with the goal of identifying and reducing anticompetitive regulatory barriers. The FTC launched this inquiry in response to President Trump’s Executive Order on Reducing Anticompetitive Regulatory Barriers. * * *
    • “In a Request for Information, the FTC invites members of the public to comment on how federal regulations can harm competition in the American economy. The RFI seeks to understand what federal regulations have an anticompetitive effect. Members of the public—including consumers, workers, businesses, start-ups, potential market entrants, investors, and academics—are encouraged to comment.
    • “The public will have 40 days to submit comments at Regulations.gov, no later than May 27, 2025. Once submitted, comments will be posted to Regulations.gov.
    • “Comments submitted to the U.S. Department of Justice Anticompetitive Regulations Task Force at Regulations.gov that contain information falling within the scope of the FTC’s RFI do not need to be resubmitted in response to the FTC’s RFI.” 
  • When will OPM invite deregulatory ideas from the public? Speaking of OPM,
  • Federal News Network tells us,
    • “The Office of Personnel Management faces a steep bill for employee relocation expenses, as it plans to bring staff working remotely back to the office.
    • “As part of its return-to-office plans, OPM is planning to spend nearly $42 million to relocate approximately 250 employees — spending about $166,000 per employee.
    • “The relocation cost per employee is higher than the annual salary of most federal employees, according to recent data analysis from the Pew Research Center. It also exceeds the maximum salary a career federal employee can receive under the General Schedule pay scale (not including locality pay). An OPM spokesperson declined a request for comment.
    • “OPM will pay certain mandatory relocation expenses. But the agency told employees in an April 4 email, first reported by Federal News Network, that “it is unlikely we will have the financial resources to relocate a significant number of employees who are greater than 50 miles from an OPM site.”
  • Govexec informs us,
    • “The Office of Personnel Management last week issued new guidance encouraging agencies to pay political appointees the maximum federal salary and removing career HR workers from the appointment process.
    • “The April 10 memo from acting OPM Director Charles Ezell to agency heads reminds them of the “great flexibility” they have when setting the pay of employees hired under Schedule C of the federal government’s excepted service, the portion of the federal workforce made up of low-level political appointees.
    • “Such flexibility is important to attract highly-qualified Schedule C employees to serve in important confidential, policy-determining, policy-making and policy-advocating roles,” Ezell wrote. “Well-qualified Schedule C employees are needed ‘to drive the unusually expansive and transformative agenda the American people elected President Trump to accomplish.’”
    • “The memo notes that Schedule C salaries cap out at $195,200. And it instructs agencies to “revoke delegations and sub-delegations” provided to agency HR employees as part of their work onboarding and vetting political appointees on behalf of the White House.”
  • Per an OPM news release,
    • “For the first time, U.S. Office of Personnel Management (OPM) personalized Retirement Booklets are now accessible online as digital downloads [at] servicesonline.opm.gov.”
  • MedTech Dive also points out,
    • “The Trump administration is investigating the effects of pharmaceutical imports on national security, disclosing Monday a probe that is likely to lay the foundation for sector-wide tariffs in the near future.
    • “The investigation, which was announced in a federal notice posted online, appears to be wide-ranging, covering branded and generic medicines, as well the active drug ingredients they contain. It will be conducted by the Department of Commerce under a legal authority known as Section 232, which President Donald Trump used earlier this year to expand duties on steel and aluminum.”
  • Per Beckers Clinical Leadership,
    • “CMS is proposing to modify several hospital quality measures and remove four others, including those focused on health equity and social drivers of health.
    • “The agency outlined the changes April 11 as part of its 2026 proposed rule for the Medicare payment systems that cover inpatient and long-term care hospitals.” 

From the judicial front,

  • Fierce Healthcare notes,
    • “Originally approved by the FDA in 1998, Amgen’s Enbrel is still sailing along without facing biosimilar competition in the United States. And unless a court rules otherwise, the Southern California company will retain its patent protection on the inflammatory disease medicine until 2029.
    • “Hoping to alter the timetable is Swiss generics and biosimilars specialist Sandoz, which has filed an antitrust lawsuit in federal court in Virginia claiming that Amgen has blocked competition to “unlawfully extend its monopoly,” according to the complaint.
    • “Amgen, according to the lawsuit, allegedly did this by purchasing patent rights from one of its competitors, Swiss pharma giant Roche, which was developing a product from the same drug class to compete with Enbrel. Without these patents, Enbrel would have been subject to competition from biosimilars—as was the case in Europe—by as early as 2016.
    • “Sandoz is seeking an injunction preventing Amgen from using the patent rights to block biosimilar competition. Sandoz wants to launch its Enbrel biosimilar Erelzi as soon as possible. The company also is pursuing treble damages, which could be tripled, according to antitrust law.”
  • and
    • “The Department of Justice will head to mediation with UnitedHealth Group and Amedisys April 18 as part of an ongoing antitrust lawsuit.
    • “Both companies are attempting to finalize a $3.3 billion merger, which was challenged under the Biden administration Nov. 12 for allegedly threatening competition in the home health and hospice industry. Now, mediation will occur Aug. 18, as signed by Magistrate Judge Susan Gauvey on April 10.” 

From the public health and medical research front,

  • The American Medical Association lets us know what doctors wish their patients knew about asthma. “Asthma can be life-threatening if you don’t get treatment. Two physicians, from Bayhealth and Rush University System for Health, share more.”
  • Cardiovascular Business relates,
    • “Following a Mediterranean-style diet that still leaves room for lean beef is associated with significant improvements in blood pressure (BP) and vascular health, according to new data published in Current Developments in Nutrition.
    • “The Mediterranean diet, named after the traditional eating habits of Greece and Italy, is based on whole grains, fruits, vegetables, legumes, nuts, seeds and olive oil. It primarily focuses on plant-based options, but does permits fish, seafood, poultry and dairy products to be eaten occasionally. 
    • “The Mediterranean diet is often viewed as one of the healthiest ways a person can eat. The team behind this latest analysis aimed to learn just how flexible these diets can be. If someone follows a Mediterranean-style diet, but wants to enjoy a little more meat, what does that mean for their cardiovascular health?
    • “Increasingly, the importance of customizing dietary choices to reflect personal preferences is recognized to promote sustained adherence to a healthy dietary pattern,” wrote first author Jennifer Fleming, PhD, an assistant teaching professor in the department of nutritional sciences at Penn State, and colleagues. “Therefore, although current dietary guidance consistently recommends limiting red meat, more clarity is needed about the amount of lean unprocessed red meat that can be incorporated into healthy dietary patterns that promote cardiovascular health.”
  • STAT News reports,
    • “Verve Therapeutics said initial data show that its investigational gene-editing therapy lowered cholesterol without inducing serious side effects, a positive step for the company after it paused development of an earlier treatment due to safety concerns.
    • “The early data from an ongoing Phase 1 study show that a single infusion of the therapy, called Verve-102, led to greater decreases in “bad” LDL cholesterol with higher doses, according to an announcement Monday. Among the four participants who received the highest dose of 0.6 mg/kg, they experienced an average 53% reduction in cholesterol.” * * *
    • “While the Verve-102 data are early, they move the company closer to its goal of using a one-time therapy to target a common condition that continues to be one of the leading killers in the developed world. The current chronic drugs that inhibit PCSK9 are not enough for patients with higher cholesterol, Verve argues, since patients often don’t take them consistently.”
  • The New York Times calls attention to a new study.
    • Middle-aged and older adults who sought hospital or emergency room care because of cannabis use were almost twice as likely to develop dementia over the next five years, compared with similar people in the general population, a large Canadian study reported on Monday.
    • When compared with adults who sought care for other reasons, the risk of developing dementia was still 23 percent higher among users of cannabis, the study also found.
    • The study included the medical records of six million people in Ontario from 2008 to 2021. The authors accounted for health and sociodemographic differences between comparison groups, some of which play a role in cognitive decline.
    • The data do not reveal how much cannabis the subjects had been using, and the study does not prove that regular or heavy cannabis use plays a causal role in dementia.
  • The Wall Street Journal considers whether long-Covid is rewriting the rules of aging. Brain decline alarms doctors. Millions of long-Covid patients continue to struggle with cognitive difficulties.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Pfizer is halting development of its experimental weight-loss pill, as the booming obesity drug market remains out of reach for the drug giant.
    • “The company said Monday the stoppage comes after it reviewed clinical data and a study subject developed a liver injury that might have been caused by the drug, called danuglipron.” 
  • The benefits consulting firm WTW offers a report titled “GLP-1 Drugs in 2025: Cost, access and the future of obesity treatment. “Employer health plans brace for another year of soaring costs as GLP-1 utilization continues to rise — per member per month spending on these medications nearly doubled each year since 2021.”
  • Per Beckers Payer Issues,
    • “Medicare Advantage plans spent $38 billion on non-Medicare benefits in 2024, according to a Medicare Payment Advisory Commission report. 
    • “The group, which advises Congress on Medicare issues, held a meeting April 10. According to a presentation, MA plans received $83 billion in rebates from the federal government. Plans used these rebates to cover non-Medicare, or supplemental, benefits. These benefits include hearing, vision and dental care alongside fitness reimbursements, over-the-counter allowances and other benefits. These rebates are also used to reduce cost sharing and provide prescription drug benefits. 
    • “According to MedPAC, current data on supplemental benefit use in MA is inadequate to determine the value the funding is providing.” 
  • Per Fierce Healthcare,
    • “Average physician pay rose 3.6% between 2023 and 2024, from $363,000 to $376,000—about in line with recent years but well behind increases from before the pandemic.
    • “That’s according to Medscape’s latest physician compensation report, which also highlighted particularly narrow increases in year-over-year compensation for primary care docs (1.4%, from $277,000 to $281,000) and specialists (1%, from $394,000 to $398,000).
    • “The annual survey also counted more specialties reporting pay drops than pay increases, as well as a shrinking percentage of doctors who feel fairly compensated and a widening of pay gaps across gender and racial and ethnic lines.”
  • Beckers Hospital Review adds,
    • “Annual average compensation for U.S. physicians in four medical specialties surpassed $500,000 in 2024, according to Medscape’s “Comparing Your Pay Against Your Peers’: Medscape Physician Compensation Report 2025.“
    • “Orthopedic specialists topped the list as the highest-paid physicians last year, while those practicing public health and preventive medicine reported the lowest earnings.
    • “With the exception of anesthesiology, all seven of the top-earning specialties in 2024 have consistently ranked among the 10 highest-paid specialties in each of the last five editions of the annual report.”