Scheduling note: Because one of the FEHBlog’s children is getting married on May 1, there will be no Friday report this week.

From Washington, DC,

• Federal News Network reports,
  • “President Donald Trump swiftly signed a bipartisan legislation Thursday to fund much of the Department of Homeland Security, but not its immigration enforcement operations, shortly after the package won final approval in the House, ending the longest agency shutdown in history.” * * *
  • “The White House had urged Congress this week to act, warning that the money Trump tapped to temporarily pay TSA and other workers through executive actions was drying up.” * *
  • “With the budget resolution now adopted by the House and Senate, lawmakers will next draft the actual $70 billion ICE and Border Patrol funding bill, with voting expected in May. 
  • “Trump has said he wants it on his desk by June 1.”
    
• The Wall Street Journal reports,
  • “President Trump is withdrawing his nomination of healthy-food advocate Dr. Casey Means to serve as U.S. Surgeon General, after it became clear that the champion of his administration’s Make America Healthy Again agendawas unable to secure support in the Senate for confirmation.
  • “The president said Thursday that he instead would nominate Dr. Nicole B. Saphier, the director of breast imaging at Memorial Sloan Kettering Cancer Center Monmouth and a former Fox News contributor, for the role. * * *
  • “Trump’s new nominee, Saphier, has supported Kennedy’s efforts to probe the cause of rising autism rates in the U.S., but has expressed some criticism of his approach. “Mr. Kennedy’s commitment to addressing the autism epidemic is a welcome change. But as a physician, mother and medical journalist, I am deeply concerned—not with Mr. Kennedy’s intent, but with his methods,” Saphier wrote last year in a Wall Street Journal opinion column.”
  • “She is also a supporter of the MMR vaccine and has publicly cited studies showing no link between the vaccine and autism. Saphier has praised Trump for delivering Covid-19 vaccines through Operation Warp Speed, but criticized mandates under the Biden administration that she says undermined confidence in the vaccine.”
    
• STAT News adds,
  • “The Food and Drug Administration has named Katherine Szarama as the acting director of the Center for Biologics Evaluation and Research, which regulates vaccines, gene therapies, and the blood supply. 
  • “A Health and Human Services official confirmed the move, which was first reported by Politico, to STAT. 
  • “She is replacing Vinay Prasad, who left the agency on Thursday after a tumultuous tenure during which he issued a series of controversial decisions on rare disease drugs and vaccines. FDA Commissioner Marty Makary said in March that Prasad would return to the University of California San Francisco. 
  • “Szarama joined the FDA at the end of last year to serve as Prasad’s deputy. She trained as a biophysicist at Johns Hopkins and the Karolinska Institutet. Later, she worked as a research analyst at the Centers for Medicare and Medicaid Services, a director of clinical trials at Arnold Ventures, and a program manager at the Advanced Research Projects Agency for Health, according to her LinkedIn profile.” 

• Per a CMS news release,
  • “Following overwhelming interest from prescription drug manufacturers, the Centers for Medicare & Medicaid Services (CMS) is extending the application deadline for drug manufacturers to apply to the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model. The deadline extension to June 11, 2026, from April 30, 2026, provides interested drug manufacturers, particularly those that are small to mid-sized, with more time to engage with the CMS Innovation Center, review participation information and prepare their application to join the model.
  • “Additionally, CMS is extending the deadline for drug manufacturers to enter into participation agreements from June 30, 2026, to July 17, 2026. Companies that manufacture at least one drug and that participate in the Medicaid Drug Rebate Program are eligible to apply to participate in the GENEROUS Model, which is intended to offer improved and streamlined access for state Medicaid programs to participating manufacturers’ products. 
  • “Interested drug manufacturers that wish to schedule a meeting with CMS about their potential participation in the model should contact generousmodel@cms.hhs.gov.” 

• Tammy Flanagan, writing in Govexec, helpfully “sorts through Medicare myths in federal retirement decisions.”
  • “Common assumptions about Part B, IRMAA and FEHB coordination can obscure how coverage and costs actually play out over time.” Check it out.

From the Food and Drug Adminstration front,

• Per FDA news releases,
  • “The U.S. Food and Drug Administration today approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with dementia due to Alzheimer’s disease in adults. The drug is the first FDA-approved treatment for this condition that is not an antipsychotic. FDA initially approved Auvelity in 2022 to treat major depressive disorder in adults.
  • “This approval represents a significant advancement in our ability to help patients and families dealing with one of the most challenging aspects of Alzheimer’s disease,” said FDA Commissioner Marty Makary, M.D., M.P.H. “With today’s action, patients and their families have access to an additional important treatment for complications of this devastating disease.”
  • “Agitation is a common and distressing symptom in patients with Alzheimer’s disease dementia, characterized by excessive motor activity, or verbal or physical aggression. It can significantly impact quality of life for patients and caregivers.”  * * *
  • “The FDA granted breakthrough therapy designation and priority review designation for this action. The approval of Auvelity for agitation associated with dementia due to Alzheimer’s disease was granted to Axsome Therapeutics.”
• and
  • “The U.S. Food and Drug Administration today announced it is proposing to exclude semaglutide, tirzepatide, and liraglutide on the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances. 
  • “The 503B bulks list identifies bulk drug substances that outsourcing facilities may use in compounding under the conditions of section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In most cases, outsourcing facilities cannot compound drugs using bulk drug substances unless the substance appears on the 503B bulks list, or the compounded drug is on the FDA’s drug shortage list at the time of compounding, distribution, and dispensing. 
  • “After evaluating the nominations for these three substances, the FDA did not identify a clinical need for outsourcing facilities to compound semaglutide, tirzepatide, and liraglutide from bulk drug substances. 
  • “When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This action reflects our responsibility to protect patients and preserve the integrity of the drug approval process while continuing to provide a transparent, science-based pathway for public input.”
    
• Healio tells us,
  • “The FDA approved Breztri Aerosphere, a single-inhaler triple therapy, as a maintenance treatment for patients aged at least 12 years with asthma, according to a press release from AstraZeneca.” * * *
  • “Notably, Breztri Aerosphere is already FDA approved as a maintenance treatment for patients with COPD.”
    
• MedTech Dive informs us,
  • “The Food and Drug Administration has recommended that users of Trividia Health’s True Metrix devices switch to other methods of testing their blood glucose. 
  • “Officials made the recommendation on Tuesday because the devices show the same error code when a patient has very high blood glucose or when there is a problem with the test strip.
  • “Trividia has recalled millions of owners’ booklets and systems instruction documents in response to the problem. The meter, test strips and control solution remain on the market.”

From the public health and medical / Rx research front,

• Beckers Clinical Leadership reports
  • “The CDC sent an alert to state and local health departments April 27, warning that additional measles cases are expected over the next few months.
  • “With continued measles transmission in areas across North America and expected increases in international and domestic travel and large events during spring and summer, additional measles cases are anticipated in the coming months,” the alert said.” 

• Radiology Business points out,
  • “Nearly half of women eligible for breast cancer screening are confused on when exactly they should begin said screenings, according to new survey data. 
  • “The survey was the result of a collaboration between the Ohio State University Comprehensive Cancer Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. It was distributed in early April and included a sample of more than 1,000 women. Responses revealed that 44% of participants still believe they should begin breast cancer screening starting at age 50. While this assumption is in line with prior recommendations, the U.S. Preventive Services Task Force updated its guidelines in 2024 to recommend women at average risk undergo biennial screening starting at age 40.”

• The Washington Post points out,
  • “Some physicians and researchers have argued for years that emotional dysregulation is not peripheral to ADHD but a central, overlooked part of the condition. Yet this symptom does not appear in the formal diagnostic criteria for ADHD in the manual that doctors use to classify mental disorders. That gap has left clinicians without a clear way to categorize what they’re seeing: Are these children best understood as having severe anxiety, as being on the autism spectrum, or as something else entirely? Or does ADHD itself need to be more broadly defined?
  • “A study published in JAMA Psychiatry this year analyzing 1,154 brain scans of children and adolescents offers fresh evidence for reevaluating the medical establishment’s definition of the disorder.
  • “The researchers grouped three forms of ADHD identified in the imaging into familiar — and one less familiar — categories: predominantly inattentive; predominantly hyperactive/impulsive; and a more severe, combined presentation marked by emotional dysregulation or difficulty managing and responding to emotions in a controlled, appropriate way.
  • “The findings are part of a broader shift: Advances in brain imaging are pushing scientists beyond symptom-based labels toward biologically grounded classifications of neurological conditions — an approach already reshaping autism research, where a study published last year identified four distinct subtypes.”

• STAT News relates,
  • “Body mass index has its limitations, but for now it’s the metric medicine often defaults to when predicting weight-related health problems. A new tool promises to better define who’s at risk for obesity complications, based on measures that include BMI but also family history, diet, current illness, and socioeconomic factors culled from medical records.” * * *
  • “We really wanted to have an integrated model that enables us to look at not one, but 18 different obesity-relevant complications,” Claudia Langenberg, co-author of a study about the new model published Thursday in Nature Medicine, said in a media briefing Tuesday. She is director and professor of medicine and population health at Precision Healthcare University Research Institute of Queen Mary University of London.
  • “The new tool, called OBSCORE, stratifies 10-year risk for different outcomes at 5.7%, 1.8%, 0.9%, 0.4%, and 0.1% for death from, for example, cardiovascular causes. 
  • “What needs to happen next is to take this very helpful score and to incorporate it, as the team have done, with evidence from trials to show that people are not only at risk, but estimate what their capacity to benefit is — and then the cost-effectiveness of intervention,” co-author Nick Wareham, co-director of the Institute of Metabolic Science at the University of Cambridge, said at the briefing.”
  • “Experts not involved in the study praised its ambition to predict obesity’s serious ramifications, but they differed on how well this step toward early recognition and refined response might play out.”
    
• The Washington Post informs us,
  • “A drug taken by thousands of Americans to improve longevity might have an unexpected side effect, a study has found. It may blunt some of the health benefits of exercise.
  • “The drug, rapamycin, is approved by the Food and Drug Administration to prevent organ-transplant rejection in people. But recent studies in yeast, flies and mice showed that relatively low doses of the drug often increase the creatures’ lifespans, prompting many longevity enthusiasts to start using it off-label to extend their lifespans.
  • “The new study, published this month in the Journal of Cachexia, Sarcopenia and Muscle, is among the first to look at interactions between rapamycin and exercise. The researchers anticipated rapamycin would enhance the effects of exercise, while also initiating health improvements of its own.”
  • “But the results surprised them, said Brad Stanfield, a physician and researcher in Auckland, New Zealand, who led the study. The sedentary, older people taking a low dose of rapamycin once a week during the study wound up gaining less strength and physical function from an exercise program than other volunteers of the same age who were taking a placebo. They also developed more aches, fatigue and, in one case, a serious infection.
  • “These findings resonate because, exercise is the most effective way to improve health and longevity as we age. “It is important to understand how potential health span-extending drugs” such as rapamycin “interact with other health span-extending treatments like exercise,” said Benjamin Miller, who studies aging and metabolism at the Oklahoma Medical Research Foundation in Oklahoma City. He was not involved with the new study.
  • “Since exercise is the benchmark,” he continued, “we do not want to inhibit its potential benefits.”
    
• Health Day tells us,
  • “Screening for dementia doesn’t appear to stress out seniors’ families
  • “Family members whose seniors received screening were no more anxious than those who didn’t 
  • “However, screening alone did not lead to family members better prepared for caregiving.”

From the healthcare business and artificial intelligence front,

• The Wall Street Journal reports,
  • “Cigna Group will exit the Affordable Care Act market next year, the latest sign of turmoil in a business that has been hit hard by the loss of federal subsidies.
  • “Cigna will be the second major health insurer to leave the rapidly shrinking ACA market, after CVS Health’s Aetna stopped offering plans at the start of this year.” 

• Modern Healthcare adds,
  • [Cigna] reported first-quarter profit ahead of Wall Street estimates and lifted its outlook for the year as healthcare expenses in its medical plans came in lower than forecasts.
  • Adjusted earnings of $7.79 a share topped the average analyst estimate in a Bloomberg survey. Cigna nudged its 2026 profit outlook up by 10 cents a share to at least $30.35, the company said in a statement Thursday. A key gauge of medical costs was more favorable than Wall Street expected. 
  • The results extend a string of favorable reports from US health insurers for the start of 2026. Cigna’s medical plan business drove the company’s earnings, while the company’s Evernorth health services segment, which includes the largest US drug benefits manager, powered revenue growth. Selling, general and administrative expenses declined from a year ago.

• Fierce Healthcare relates,
  • “Tenet Healthcare topped its earnings expectations for the year’s first quarter, with CEO Saum Sutaria, M.D., crediting the company’s long-term strategy and “old-fashioned discipline” in the face of volume disruptions plaguing providers in the opening months of 2026.
  • “The company’s net income for the quarter was $8.01 per diluted share ($702 million), or a market consensus-beating 10.6% year-over-year increase to $4.82 per share after adjustments (including over $400 million received from the early severance of a revenue cycle contract with CommonSpirit Health). Net operating revenues increased 2.8% year over year to $5.37 billion, falling short of the market’s consensus estimate.
  • “Executives said they were pleased with the performance of both major segments of Tenet’s business, its ambulatory surgery business and its hospitals.” 
• and
  • “Parsley Health, a functional medicine provider, is now in-network with all major commercial insurers nationwide.
  • “The company’s in-network reach spans plans covering 150 million lives, including Aetna, Cigna, UnitedHealthcare, Blue Cross Blue Shield, Humana and Centene. Eligible services covered include provider visits, diagnostic testing and prescriptions. Parsley members must pay an annual non-covered program fee of $1,500 for wraparound support.
  • “The announcement builds on Parsley’s phased expansion into insurance over the past two years, which began in New York and then California. Today’s nationwide expansion represents a tenfold increase in coverage, per the company. The company offers healthcare via telehealth nationwide or in-person in Los Angeles and New York City.” * * *
  • “Functional medicine aims to look at the whole person and get under the hood of symptoms to identify and address root causes of disease. Parsley takes a multidisciplinary approach, with members getting a care team of board-certified doctors, registered nurses, functional nutritionists, care coordinators, member experience advisors and access to the digital platform to track progress, access data and more. Members also get unlimited messaging with their care team.” 
    
• The Wall Street Journal tells us,
  • “Booming sales of weight-loss shots fueled strong revenue and profit growth for Eli Lilly LLY  in the latest quarter, as robust consumer demand helped offset falling prices for the drugs.
  • “The results blew past Wall Street expectations, and Lilly raised its forecast for full-year 2026 sales and profit.” * * *
  • “The results cement the Indianapolis company’s dominance in the anti-obesity drug market as it seeks to extend that to weight-loss pills. Lilly released its new weight-loss pill Foundayo this month, competing with Novo Nordisk’s Wegovy pill, which came out in January.
  • “Early prescription data showed a slower start for Lilly’s pill than for Novo Nordisk’s, but analysts predict Lilly’s pill will eventually be a big seller.
  • “Both companies think there is a large, untapped market for pill versions of weight-loss drugs, because some people don’t like needles or find pills more convenient.”
• and
  • “Merck reported higher first-quarter sales and raised its full-year earnings guidance as demand for its flagship Keytruda cancer drug continues to grow.
  • “Sales rose 5% to $16.29 billion, boosted by 12% growth for Keytruda. Wall Street had expected $15.85 billion, according to FactSet.
  • “The company has been adding to its portfolio as it braces for Keytruda to lose the protection of its main U.S. patent, which expires in 2028, opening the door for lower-cost versions to compete.
  • “Last year, the FDA approved a form of Keytruda administered by injection rather than intravenously, which could help the company offset the impact of the patent expiration. Merck has said the new form of the drug, called Qlex, provides greater convenience as it can be offered in a wider variety of settings and can be given in one minute every three weeks as opposed to a 30-minute IV infusion.
  • ‘In the first quarter, the company recorded $128 million in Qlex sales.”
• and
  • “Bristol Myers Squibb BMY posted higher first-quarter revenue boosted by its portfolio of newer treatments for heart and blood conditions.
  • “The biopharmaceutical company on Thursday posted a profit of $2.68 billion, or $1.31 a share, compared with $2.46 billion, or $1.20 a share, a year earlier.
  • “Stripping out certain one-time items, adjusted per-share earnings were $1.58, ahead of the $1.42 anticipated by analysts, according to FactSet.
  • “Revenue rose 3% to $11.49 billion. Analysts surveyed by FactSet forecast revenue of $10.93 billion.
  • “Sales in Bristol Myers Squibb’s growth portfolio rose 12%, driven by Camzyos, Breyanzi and Reblozyl. The drugs are designed to treat heart disease, lymphoma and blood disorders, respectively.”

• Health Exec notes “six things the hospital-at-home model needs to scale up nationally.”
  
• Beckers Payer Issues calls attention to “five ways insurers are betting big on AI.”
  • “Payers have been experimenting with internal and member-facing capabilities, while grappling with health system AI use, as well. As insurers build upon their substantial investments and weigh how humans can stay “in the loop,” here is where that money is actually going.”