From Washington, DC,

• Per an HHS news release.
  • “The U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) is holding the first Healthcare Advisory Committee meeting on May 18 at 2 p.m. The public meeting will focus on introducing Committee members, outlining the vision of the Committee and establishing Committee bylaws.
  • “The Healthcare Advisory Committee, was established earlier this year as a federal advisory body comprised of leaders from across the healthcare system to provide expert advice on improving, strengthening and modernizing U.S. healthcare. * * *
  • “The meeting will be held via a virtual webinar only and pre-registration is not required. Webinar details and full agenda will be made available at: https://www.cms.gov/priorities/healthcare-advisory-committee/overview
  • “To view the Federal Register Notice on the upcoming Healthcare Advisory Committee meeting, visit: https://www.federalregister.gov/public-inspection/2026-09444/hearings-meetings-proceedings-etc-healthcare-advisory-committee.”

• The American Hospital Association News adds,
  • “The Department of Health and Human Services Administration for Community Living has launched the first phase of its Health at Home Challenge, a competition to support community care networks that have partnered with health care providers supporting dually eligible Medicare and Medicaid beneficiaries. Each phase of the competition offers up to $2 million in prize funding for winning teams. The first phase, currently underway and continuing through July, will reward up to 10 teams for implementation strategies to scale comprehensive services that reach high numbers of dually eligible and near-dually eligible beneficiaries. The second phase will reward up to five teams for accelerating implementation of winning strategies from the previous phase. Phase three will reward up to three teams for demonstrating the scale and impact of the winning programs selected from phase two.”

• Federal News Network reports,
  • “Federal employee workplace disputes are coming under more scrutiny from a top committee Republican who argues that agencies have an “excessive reliance” on reaching case settlements rather than pursuing litigation.
  • “House Oversight and Government Reform Committee Chairman James Comer (R-Ky.) is raising concerns over what he described as high numbers of “sue-and-settle” cases involving federal employees. He suggested that if agencies litigated more cases, they would likely win more often.
  • “Comer’s letter, sent this week to the Office of Personnel Management, cited Merit Systems Protection Board data from fiscal 2005 to fiscal 2015 that showed during that time, 68% of federal employee cases reached settlements. And out of cases that were litigated, more than 80% of agency adverse action decisions were upheld.”

From the Food and Drug Administration front,

• The Wall Street Journal reports,
  • “Food and Drug Administration Commissioner Marty Makary resigned Tuesday after months of policy fights with top officials in the Department of Health and Human Services and the White House.
  • “His departure became official after President Trump signed off last week on a plan to fire Makary, The Wall Street Journal previously reported. Makary offered his resignation, effective Tuesday.
  • “Everybody wants that job,” Trump said. “Marty is a terrific guy and he’s going to go on and lead a good life. He was having some difficulty.” He added on his Truth Social platform that Kyle Diamantas, the deputy commissioner for food, would take over leading the agency in an acting capacity.
  • “The president also posted a text message from Makary that included his resignation and a list of what he considered his accomplishments, such as reducing drug-review times. “It’s been the honor of a lifetime to serve as your FDA Commissioner. I am forever grateful,” Makary said.”

• MedTech Dive reports,
  • “Artera has received Food and Drug Administration clearance for an artificial intelligence tool that predicts the likelihood of a certain form of breast cancer developing distant metastases.
  • “The clearance, which Artera disclosed Wednesday, covers technology that uses histopathology images and clinical variables to stratify patients into low- and high-risk groups.
  • “Insights into the risk of distant metastases could improve decisions about the use of treatments including chemotherapy, the company said.”
• and
  • “Johns Hopkins University spinoff Bayesian Health received 510(k) clearance for an artificial intelligence tool to help detect sepsis early.
  • “Sepsis is a life threatening response to infection. Detecting sepsis earlier can improve a patient’s chance for survival. Once a clinician suspects sepsis, the clock has been running, often for hours or even days, Bayesian Health founder and CEO Suchi Saria said in a Tuesday statement.
  • “Other Food and Drug Administration-authorized sepsis tools on the market require a physician to suspect sepsis first. Bayesian’s system, which uses electronic health records and AI, can detect sepsis nearly two to 48 hours faster than traditional methods, the company said.”

• The American Hospital Association notes,
  • “The Food and Drug Administration has identified a Class I recall of convenience kits by Aligned Medical Solutions that contain recalled Namic Angiographic Control Syringes by Medline.”

From the public health and medical / Rx research front,

• STAT News reports,
  • “Alcohol is wreaking havoc on U.S. public health. American society looks the other way.”
  • “Confronting heavy drinking could be one of the best ways to improve health and save lives.”
  • * * * “Of 178,000 deaths that occur each year from alcohol, roughly one-third are from causes like car crashes and alcohol poisoning. The rest are from cancer, heart disease, liver failure, and other chronic conditions that result from sustained heavy drinking. As far as drugs are concerned, alcohol’s toll is only outpaced by the prolonged damage of tobacco. 
  • :But though the U.S. has dramatically cut tobacco use, it has never made a serious effort to curb alcohol-related harms other than in the infamous era of Prohibition. Over twice as many Americans consumed alcohol in 2024 than used tobacco products, federal estimates suggest.” * * *
  • “Recent polls suggest drinking levels have reached historic lows in the U.S., with about half of adults abstaining. Last year, while much of the alcohol industry struggled against new headwinds, the nonalcoholic sector grew. Companies launched alcohol-free products and shifted their marketing to align with health-conscious customers. 
  • “Strikingly, there is little evidence that the mocktail trend is driving actual health improvements, experts told STAT. That may be because of lagging data. Or it may reflect how in many cases, market research suggests drinkers are adding nonalcoholic beverages to their rotation, rather than switching over entirely. The groups that could most benefit from cutting back, including heavy drinkers, may not be interested at all.
  • “Meanwhile, heavy and binge drinking — practices known to be particularly harmful to health — have remained at pandemic levels among key groups, including older adults and teenagers. Five million underage people used alcohol in 2024, and over half of those 12 to 20 years old engaged in binge drinking, defined as four or more drinks in one sitting for women, or five for men.”  

• The New York Times brings us up to date on recent developments in treating pancreatic cancer.

• MedPage Today relates,
  • “Despite improvements in survival, the incidence of stage IV breast cancer increased significantly from 2010 through 2021, according to a U.S. population-based cohort study.
  • “The age-adjusted incidence rate of de novo stage IV breast cancer significantly increased from 9.5 cases per 100,000 females in 2010 to 11.2 cases in 2021, an annual percentage change (APC) of 1.2% (95% CI 0.8-1.6), reported José P. Leone, MD, of the Dana-Farber Cancer Institute in Boston, and colleagues.
  • “Among males, there was also a statistically significant increase in stage IV incidence, from 0.12 cases per 100,000 in 2010 to 0.20 cases in 2021, an APC of 3.7% (95% CI 1.0-6.5), they noted in JAMA Network Open.
  • “Moreover, the incidence of stage IV breast cancer increased significantly across age groups and numerically across all races and ethnicities.”
• and
  • “Two non-pharmaceutical approaches for irritable bowel syndrome (IBS) feasibly offered patients symptom relief, according to research presented at the annual Digestive Disease Week meeting. 
  • “In a post-hoc analysis of a small single-arm trial, IBS patients’ mean scores on a 0-100 scale dropped from baseline for pain (37 to 21.6), discomfort (48.4 to 27.4), distention (54.8 to 30.9), and bloating (54.4 to 31.8) after 2 weeks of an oral, palatable elemental diet followed by a 2-week follow-up period, reported researchers led by Ali Rezaie, MD, of Cedars-Sinai Medical Center in Los Angeles.
  • “Even after reintroduction of a regular diet, “a 2-week elemental diet significantly improved abdominal pain and other IBS symptoms across subtypes using FDA-recommended responder endpoints,” Rezaie and colleagues wrote in their poster. “Larger, long-term studies are needed to confirm durability and understand how it works.”
  • “And in a sham-controlled randomized trial, people with IBS who used a virtual reality (VR) program to deliver cognitive behavioral therapy (CBT) reported greater symptom improvement after 8 weeks, with scores of 244.3 versus 295.6 with sham on a 0-500 scale where higher numbers indicate more severe symptoms (P=0.026), reported Christopher Almario, MD, of Cedars-Sinai Medical Center, and colleagues.”

• Health Day informs us,
  • “About 8,500 steps a day may be the sweet spot for keeping weight off after dieting, new research shows.
  • “The findings — recently published in the International Journal of Environmental Research and Public Health — are also scheduled for presentation this week at the European Congress on Obesity in Istanbul.
  • “The most important — and greatest — challenge when treating obesity is preventing weight regain,” said lead researcher Marwan El Ghoch, a professor in biomedical, metabolic and neural sciences at the University of Modena and Reggio Emilia in Italy. 
  • “Around 80% of people with overweight or obesity who initially lose weight tend to put some or all of it back on again within three to five years,” he said. “The identification of a strategy that would solve this problem and help people maintain their new weight would be of huge clinical value.”

• The Wall Street Journal lets us know,
  • “Novo Nordisk said certain patients on its higher-dose Wegovy shot lost 27.7% of their body weight on average in a trial.
  • “The Danish drugmaker said those patients who reacted faster to treatment by losing at least 15% of their weight after the first six months went on to achieve the nearly 28% total weight loss after about a year and a half.
  • “The company said the majority of the weight loss, around 84%, from using its Wegovy shots comes from losing body fat while preserving muscle function and improving muscle health.
  • “The data was presented at the European Congress on Obesity in Turkey.”

• Cigna Health, writing in LinkedIn, discusses how employers can take advantage of Mental Health Awareness Month.
  • “Key Takeaways
    • “Offering mental health benefits is not enough—employees need a clear, guided path to find, understand, and use them.
    • “Benefits literacy is a productivity lever—clear navigation can reduce delays in care and protect vitality.
    • “Small design moves—one starting point, steady education—make the difference between availability and utilization.”

• Fierce Healthcare considers “the broken pipeline of mental healthcare for LGBTQ teenagers.”

• Beckers Hospital Review identifies the sixteen hospitals recognized by HealthGrades for deserving Outstanding Patient Experience, Patient Safety Excellence, and America’s Best Hospitals distinctions for 2026.
  • The organization evaluated 3,020 hospitals that submitted at least 100 patient experience surveys to CMS’ Hospital Consumer Assessment of Healthcare Providers and Systems between January and December 2024. Hospitals were evaluated on patient survey data on 10 patient experience measures. Recipients of the outstanding patient experience award earned the highest overall experience scores.

• Fierce Pharma points out,
  • “Alkermes has chalked up a quick clinical win from its $2.37 billion acquisition of Avadel, reporting Tuesday that a phase 3 study of the sodium oxybate Lumryz met all primary and key secondary endpoints in a rare sleep disorder.
  • “The positive readout from the Revitalyz trial in idiopathic hypersomnia comes three months after Alkermes bagged Lumryz upon closing the Avadel buyout. By demonstrating its ability to significantly reduce daytime sleepiness and other symptoms, Lumryz is moving one step closer to helping Avadel investors realize the deal’s full value.”

From the U.S. healthcare business and artificial intelligence front,

• Yesterday, the FEHBlog linked to a Modern Healthcare article about Optum Rx’s decision to implement a “new pharmacy care model that fundamentally changes how pharmacy benefits are priced and delivered — replacing traditional approaches tied to drug prices set by manufacturers or prescription volume with a transparent, fee‑based structure offered to every Optum Rx PBM customer. Here is a link to OptumRx’s news release about this decision.

• Healthcare Dive adds,
  • “Employers are looking for a simpler pharmacy benefits model, particularly an approach that eliminates rebates to send savings directly to patients, according to a survey released last week.  
  • “More than 90% of employers surveyed agreed a rebate-free model would improve transparency into prescription drug prices, according to the research by communications and reputation management firm Penta Group for Evernorth Health Services, which operates the Express Scripts pharmacy benefit manager. 
  • “Additionally, 91% said an approach that removed rebates is easier to understand, and 90% reported it would improve employee satisfaction and drug affordability.” 

• Fierce Healthcare relates,
  • “Providence’s turnaround efforts are continuing to gain steam, securing the 51-hospital nonprofit a $111 million net operating income (1.5% operating margin) for the start of 2026 and its third consecutive quarter on the right side of zero. 
  • “Financial performance numbers released Monday afternoon showed a roughly $360 million year-over-year operating improvement, when it had logged a -3.5% operating margin. Compared to then, Providence grew its operating revenues by 4.1%, to nearly $7.5 billion, while shrinking its operating expenses by 0.9%, to a bit over $7.3 billion. 
  • “The numbers, Providence said, reflect “deliberate steps” it’s taken over the past couple of years to reverse longstanding losses and generally tighten up the ship as financial headwinds, such as Medicaid funding cuts, loom for providers. 
  • “These, the West Coast system said in a release, include “streamlining its leadership structure, reducing duplication of services, renegotiating commercial payer contracts and sharpening its focus on core services—including transferring ownership or partnering with others on non‑core services.” 

• Fierce Pharma tells us,
  • “Since Roche launched its long-acting eye disease medicine Vabysmo in 2022, Bayer and Regeneron have seen the impact on sales of their rival treatment Eylea, with the U.S. biotech taking a bigger hit.
  • “Bayer has managed to keep its annual Eylea sales relatively stable as they have toggled between 3.1 billion euros and 3.3 billion euros in each of the last four years. But that’s coming to an end this year as biosimilar competition is hitting the German company with full force.”
  • “In the first quarter (PDF), Bayer’s Eylea sales were down 24% year over year to 623 million euros ($731 million). They also declined sequentially by 11%. None of this is a surprise as Bayer has projected Eylea sales to drop 20% to 25% this year.”
  • “However, it wasn’t all bad news for Bayer’s Eylea franchise, as Chief Financial Officer Wolfgang Nickl cited “continued positive volume development” for Eylea’s longer-acting 8 mg formulation, which now accounts for 46% of the company’s overall Eylea sales.”
    
• Beckers Health IT informs us,
  • “Cleveland Clinic’s quantum computing program has moved from a pilot phase to a fully operational “innovation engine” integrated with AI, according to Lara Jehi, MD, chief research information officer at the health system.
  • “It’s been a whirlwind, and we’ve made much more progress — and much faster — than we originally anticipated,” Dr. Jehi told Becker’s.
  • “Cleveland Clinic started its quantum computing journey in 2023 when the organization formed a 10-year partnership with IBM to create a joint accelerator center to advance healthcare discoveries using AI and cloud computing. As part of that deal, IBM installed its first private-sector, on-premise quantum computing system in the U.S. at Cleveland Clinic. The quantum computer, dubbed IBM’s Quantum System One, is dedicated to healthcare research and was installed at the Lerner Research Institute on Cleveland Clinic’s main campus.”