From Washington, DC,

• Roll Call reports,
  • “Five months after announcing his esophageal cancer diagnosis, Virginia Rep. Gerald E. Connolly said Monday that he won’t seek a 10th term and also plans to step down as the top Democrat on the House Oversight and Government Reform Committee.
  • “The sun is setting on my time in public service,’’ Connolly, 75, said in a message to his constituents in Virginia’s 11th District. “With no rancor and a full heart, I move into this final chapter full of pride in what we’ve accomplished together over 30 years.” * * *
  • “Until his permanent successor on the committee is chosen, Connolly has asked Massachusetts Rep. Stephen F. Lynch to cover for him as the panel’s top Democrat, Politico reported Monday.”
  • Best wishes, Congressman.
    
• STAT News tells us,
  • “In keeping with the Trump administration’s quest to slash spending at the federal health department, it’s hired a famously thrifty technology entrepreneur to lead Medicare. 
  • “As the CEO of health IT company Collective Medical, Chris Klomp flew bargain-priced Frontier Airlines and once boasted about sleeping in rental cars and crummy motels on business trips. The office snacks were from Costco. The penny-pinching didn’t stop after the bootstrapped company raised nearly $50 million from blue chip investors like Kleiner Perkins. One morning, Klomp arrived at the company’s headquarters just outside Salt Lake City, his 1960’s teal Ford pickup loaded full of printer paper that was on sale at Staples.” * * *
  • “Under Klomp’s watch, crucial decisions will be made about the direction of Medicare. They include whether to rein in abusive coding and denials practices by private Medicare Advantage plans that cover a majority of enrollees, whether to reform how Medicare pays doctors and hospitals, and whether it will pay for a new breed of obesity medications. Because of Medicare’s reach, other insurers often follow its lead on payments and other policies, putting Klomp in a position to significantly influence the entire American health care system.”

• Healio adds,
  • “Medicare Part D coverage of obesity medications could lead to a large increase in health care costs due to the prices of the drugs, according to data from a microsimulation model published in JAMA Health Forum.
  • “As Healio previously reported, CMS decided to not move forward with a previously proposed rule to have Medicare begin covering obesity medications in the 2026 calendar year, though the agency said it could reconsider the proposal in future rulemaking.
  • “If Medicare were to cover obesity medications, however, there could be huge financial implications, according to David D. Kim, PhD, assistant professor of medicine and public health sciences at University of Chicago. 
  • “Our finding is that obesity drugs [would be] a pretty substantial cost, [about] $47 billion over the next 10 years,” Kim told Healio. “These are important numbers, because a lot of people say that GLP-1s will save a lot of money in health care because obesity is a risk factor for many other conditions. … Our paper highlighted that in some sense, GLP-1s do save money, but not enough to offset the high prices of the medication.”

• BioPharma Dive lets us know,
  • “Novavax claims it can surmount the latest regulatory hurdle hindering its quest to win full U.S. clearance of its COVID-19 vaccine, saying Monday it believes its application is still approvable pending an agreement with the Food and Drug Administration on a postmarketing clinical trial.
  • “Last week, Novavax revealed the agency had requested what’s known as a postmarketing commitment to further study the shot in clinical tests. On Friday, The Wall Street Journal reported the FDA had asked Novavax to conduct an additional randomized clinical trial, which would be a costly and time-consuming additional step for the company.
  • “A spokesperson for Novavax, contacted by BioPharma Dive Friday, said the company “cannot comment on the details of the request” while engaging with the FDA. It’s unclear when exactly the agency wants Novavax to complete the study.”

From the judicial front,

• Modern Healthcare reports,
  • “Elevance Health is facing a second lawsuit accusing it of maintaining inaccurate provider directories, also known as “ghost networks.”
  • The plaintiffs are three people covered under New York state employee health benefits who allege that Elevance Health division Carelon Behavioral Health misrepresented providers as in-network, causing them financial harm. The attorneys are seeking class-action status.” * * *
  • Pollock Cohen and Walden Macht Haran & Williams filed the lawsuit against Elevance Health subsidiary Anthem Blue and Cross Blue Shield of New York in the U.S. District Court for the Southern District of New York.
  • “The Elevance Health plaintiffs allege Carelon Behavioral Health, which administers mental health benefits to state and municipal employees enrolled in the New York State Health Insurance Program’s Empire Plan, misled policyholders seeking mental healthcare.”

From the public health and medical research front,

• STAT News reports,
  • “A clinical trial run by the National Cancer Institute seems to confirm that a single dose of the vaccine used to prevent infection with the human papilloma virus is just as effective as two — and, therefore, also helps to prevent cancer.
  • “The result could transform efforts to reach the three-quarters of children globally who should receive the vaccines but don’t. The shots prevent cervical cancer and also anal, penile, and some head-and-neck cancers. Worldwide, 350,000 women die from cervical cancer, the most common HPV cancer.
  • “I think we can all agree that one dose and two doses of … these fantastic vaccines work really well,” said Aimée R. Kreimer, the NCI investigator who presented the new data here Monday at the annual meeting of the American Association for Cancer Research. “We’re really excited about these results.”
  • “In developed countries, including the U.S., two doses of the vaccines are currently recommended. But in the clinical trial, whether one dose or two doses were used, the results were equivalent, according to the study of 20,000 girls between ages 12 and 16 in Costa Rica who were followed for 4 1/2 years. In all cases, the estimated efficacy of the vaccines was upwards of 97%.”

• Per MedPage Today,
  • “Another benefit of GLP-1 receptor agonist (RA) use may be protection from persistent atrial fibrillation (Afib or AF) after ablation, according to a large Veterans Affairs database.
  • “New initiators of these drugs in 2015-2022 — specifically people with type 2 diabetes (T2D), obesity, and active Afib — showed significant improvement in their time to first hospitalization for Afib, Afib-related procedures (cardioversion/ablation), or all-cause mortality over a median 3 years of follow-up (HR 0.87, 95% CI 0.68-0.96) when compared against controls getting a DPP-4 inhibitor (DPP4i) or sulfonylurea.
  • “Accounting for mortality as competing risk, the Afib burden trended numerically in favor of the GLP-1 RA group (HR 0.85, 95% CI 0.61-1.03), noted Varun Sundaram, MD, PhD, MSc, of Case Western Reserve University in Cleveland, in his presentation of the TRANSFORM-AF study at the Heart Rhythm Society annual meeting.
  • “This is an exciting study for people with AF, T2D, and obesity along with the clinicians treating them. This retrospective study suggests there is a cardioprotective effect of GLP-1RA compared to DPP4i in hard AF endpoints,” commented James Lo, MD, PhD, of Weill Cornell Medicine/New York-Presbyterian Hospital in New York City.

• Medical News Today warns us,
  • “A multi-decade study finds that the damage done by smoking, heavy drinking, and being physically inactive begins at a far younger age than previously understood.
  • “Although the unwanted health consequences of these habits over the long term are well-known, the research offers evidence that their negative impact, though not as severe, actually occurs over the short term.
  • “Participants in the study were assessed for depression, sense of well-being, metabolic risk, and sense of healthfulness, all of which suffered as a result of smoking, drinking, and being inactive.
  • “While it is no surprise that a lifetime of smoking, heavy drinking, and physical inactivity is a recipe for ill health later in life. 
  • “Now, a new study finds that these habits can result in health issues as young as the age of 36, including their influence on mental health.
  • “The findings of the study were recently published in the Annals of Medicine.”

• Health Day adds,
  • “Risk factors for dementia could start taking their toll as early as a person’s 20s and 30s, a new study says.
  • “Younger adults who carry known risks for dementia performed worse on memory and thinking tests between ages 24 and 44, researchers report in the May issue of the journal The Lancet: Regional Health Americas.
  • “The findings lay the groundwork for early detection of Alzheimer’s disease and dementia, researchers say.
  • “This is the first study to look at risk factors of dementia and Alzheimer’s disease in a large group of generally healthy younger adults, researchers say.
  • “Previously, research on Alzheimer’s disease risk factors has focused on individuals aged 50 and older,” lead researcher Allison Aiello, a professor of epidemiology at the Columbia University Aging Center, said in a news release.
  • “These new results show that well-established risk factors and blood biomarkers for dementia appear to start affecting cognitive function even before middle age, Aiello said.
  • “These risk factors include education level, gender, blood pressure, cholesterol, exercise and body mass index, a measure of body fat based on height and weight, results show. All these are measured using a Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) score.”

• The American Medical Association tells us what doctors wish their patients knew about insomnia.

• Benefits Pro relates,
  • “According to researchers, the survey reveals a possible cognitive dissonance: Americans know they should schedule a preventive care screening or wellness visit, but their behavior often suggests otherwise. For 65% of Americans, experiencing a health scare is what made them realize they need to be more proactive about their health. Attitudes about preventive care are often counterintuitive, however, as many of those who believe they will be diagnosed with cancer are more likely to delay screenings (62% vs. 42%).
  • “Many avoid going to the doctor instead of doing what they can to avoid a health scare or detect a problem early,” Tom Morey, Aflac’s senior vice president and chief actuary, said in a statement while also noting his own health crisis that kept him away from work for nearly two years and in and out hospitals for 18 months. “It starts with making preventive care a priority and taking steps toward establishing a trusted relationship with a primary care doctor. Personally, this helped me to feel more confident, more in control of my health, and more empowered to deal with an illness that, otherwise, may have gone undetected.”

• Health Day also informs us,
  • “Breast cancer patients fare better if they continue to exercise during their treatment, and a new program can help women get the activity they need to boost their odds, researchers say.
  • “The Comprehensive Oncology Rehabilitation and Exercise (CORE) program assesses women’s physical activity needs based on the stage to which their cancer has progressed, researchers reported today in the journal Cancer.
  • “More than 3 in 5 patients (62%) completed their referral to an exercise program designed to meet their specific needs, researchers said.
  • “CORE may serve as a model workflow algorithm aimed to integrate both exercise and rehabilitation services from time of diagnosis and beyond,” senior researcher Adriana Coletta, an investigator at the University of Utah’s Huntsman Cancer Institute, said in a news release.”

• Consumer Reports, writing in the Washington Post, points out,
  • “You often hear that fish is brain food. True, but so are eggs, pork loin and Brussels sprouts. That’s because they’re rich in choline, a nutrient related to B vitamins.
  • “Choline is critically important for a variety of body and brain functions,” says Ramon Velazquez, an assistant professor at the Arizona State University-Banner Neurodegenerative Disease Research Center in Tempe. It’s part of all cell membranes, and in recent years there’s been increasing evidence linking it to better cognitive function and even a lower risk of Alzheimer’s disease. But about 90 percent of people don’t get enough of it.”

From the U.S. healthcare business front,

• Modern Healthcare reports,
  • “Most Blue Cross and Blue Shield companies lost money last year as rising Medicaid and Medicare costs squeezed their bottom lines.
  • “The vast majority of 31 Blues companies reported weaker operating margins as membership declined and medical and pharmaceutical costs rose, according to an analysis of state financial filings that Mark Farrah Associates performed for Modern Healthcare.
  • “Across the Blues, operating margin fell 3.2 percentage points from a 0.3% gain in 2023 to a 2.9% loss in 2024. Just eight Blues companies reported positive operating margins last year.
  • “That contrasts with the annual margin growth enjoyed by national, publicly traded insurers. For-profit insurers average operating margin rose 1.6 percentage points to 2.4% in 2024, according to the health data analytics firm.”

• Beckers Payer Issues tells us fifty things to know about UnitedHealth Group.

• Fierce Healthcare relates,
  • “While health plans are not likely to feel the most acute effects from the Trump administration’s tariffs, they face downhill impacts from market volatility and rising costs, according to a new analysis from Fitch Ratings.
  • “The report examines the way tariffs could affect multiple types of insurance and estimates that health insurers in particular face moderate exposure to the slower economic growth and financial performance that are more indirect results of the tariffs.
  • “Health plans benefit in this particular case from the vast majority of their operations being domestic. However, while that suggests the impacts will be fairly limited in the short term, the effects would ramp up should the tariffs remain in place for an extended period, or if they evolve to be more restrictive.
  • “As an example, tariffs on pharmaceutical products would also likely lead to short-term cost pressures on insurers, according to Fitch.”

• FiercePharma notes,
  • “Ending a 20-year-plus drought, Merck & Co.’s Keytruda demonstrated that its use around surgery can reduce the risk of certain head and neck cancers from returning.
  • “Continuous use of Keytruda—both before and after surgery—reduced the risk of recurrence or death by 27% in patients with stage 3 or 4a, resected, locally advanced head and neck squamous cell carcinoma (HNSCC), according to results from the phase 3 Keynote-689 trial presented at the American Association for Cancer Research Annual Meeting 2025.
  • “In the study, Keytruda was added to postoperative radiotherapy with or without chemo. Investigators compared the perioperative Keytruda regimen with the sans-Keytruda standard treatment.
  • “Keynote-689 marks the first positive trial in more than two decades in resected locally advanced HNSCC, making Keytruda the first PD-1 inhibitor to mount such a benefit.”

• Per BioPharma Dive,
  • “Merck KGaA has agreed to buy biotechnology company SpringWorks Therapeutics, announcing Monday a $3.9 billion deal after months of negotiations over an acquisition.
  • “The German pharmaceutical firm will pay $47 per SpringWorks share, a small premium to the stock’s closing price Friday but 17% higher than the $40.28 it closed at on Feb. 7, the last trading day before reports emerged of the companies’ discussions.
  • “SpringWorks has developed two drugs that are approved in the U.S. to treat rare tumors. Ogsiveo is cleared for adults with desmoid tumors, while Gomekli won the Food and Drug Administration’s OK in February for adults and children with neurofibromatosis type 1 who experience symptoms from a type of benign tumor.”

• Per MedTech Dive,
  • “Medtronic has filed for Food and Drug Administration approval of its Hugo soft tissue robotic surgery system with a urologic indication, marking a major step in its bid to compete with Intuitive Surgical. The company said Saturday that it made the submission in the first quarter of 2025. 
  • “Medtronic also completed enrollment in hernia and benign gynecology studies and received approval to start a trial in oncologic gynecology procedures. The studies will support submissions for additional U.S. indications for the robot.
  • “Data from the company’s investigational device exemption study for the Hugo robot in urologic surgery, presented at the American Urological Association annual meeting, met the primary goals for safety and effectiveness, according to Medtronic.”