Thursday Report

From Washington, DC,
- Healthcare Dive summarizes the healthcare-related provisions of the various House committee budget reconciliation recommendations that the House Budget Committee will take up tomorrow.
- As promised, the Departments of Health and Human Services, Labor, and the Treasury released today a non-enforcement policy concerning the 2024 mental health parity amendments.
- “The Departments have requested that the ERIC litigation be held in abeyance while the Departments reconsider the 2024 [Mental Health Parity] Final Rule, including whether to issue a notice of proposed rulemaking rescinding or modifying the regulation through notice and comment rulemaking.
- The Departments will not enforce the 2024 Final Rule or otherwise pursue enforcement actions, based on a failure to comply that occurs prior to a final decision in the litigation, plus an additional 18 months. This enforcement relief applies only with respect to those portions of the 2024 Final Rule that are new in relation to the 2013 final rule. The Departments note that MHPAEA’s statutory obligations, as amended by the CAA, 2021, continue to have effect.
- The Wall Street Journal reports,
- “The Trump administration is planning to drop recommendations that pregnant women, teenagers and children get Covid-19 vaccines as a matter of routine, according to people familiar with the matter.
- “The Department of Health and Human Services, led by Secretary Robert F. Kennedy Jr., is expected to remove the Centers for Disease Control and Prevention’s recommendations for those groups around the same time it launches a new framework for approving vaccines, the people said.
- “The exact timing of the announcement wasn’t clear, the people said, though it was expected in the coming days.”
- Tammy Flanagan, writing in Govexec, discusses “Getting ready to retire. What you should do and how you should approach your retirement and health benefits planning before leaving federal service.”
From the FDA front,
- Per an HHS press release,
- “The U.S. Food and Drug Administration today is taking a major step to increase transparency and ensure the safety of chemicals in our food. The agency is launching a stronger, more systematic review process for food chemicals already on the market—especially those that concern consumers most.
- “No parent should ever worry about what’s in their child’s food,” said HHS Secretary Robert F. Kennedy, Jr. “We’re taking decisive action and using every authority we have to clean up the food supply and protect American families.”
- “Under the leadership of Secretary Kennedy and FDA Commissioner Martin A. Makary, M.D., M.P.H., the FDA will roll out several key actions over the coming months:
- “A modernized, evidence-based prioritization scheme for reviewing existing chemicals. A draft will be released for public comment soon.
- “A final, systematic post-market review process shaped by stakeholder input.
- “An updated list of chemicals under review, including BHT, BHA, and ADA. The FDA will also take steps to expedite its review of chemicals currently under review like phthalates, propylparaben, and titanium dioxide. FDA will continue to share information about the status of this work on its public website as part the agency’s push for greater transparency.”
- Fierce Pharma adds,
- “Six years after Merck bought out Peloton Therapeutics, the New Jersey drugmaker is not remaining stationary with the crown jewel of the deal.
- “On Wednesday, the FDA approved a third indication for Welireg (belzutifan), signing off on the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor to treat patients with rare pheochromocytoma or paraganglioma (PPGL) tumors in the endocrine system.
- “The approval covers patients 12 and older with locally advanced, unresectable or metastatic PPGL and makes Welireg the first oral treatment for advanced PPGL, per Merck.”
- Per MedPage Today,
- The FDA granted a first-ever approval for a first-line therapy for anal cancer to the PD-1 inhibitor retifanlimab (Zynyz), the agency announced Thursday.
- The approval stipulates use in combination with carboplatin and paclitaxel in newly diagnosed locally advanced/metastatic squamous cell carcinoma of the anal canal (SCAC) or as monotherapy for patients whose disease progressed on platinum-based chemotherapy.
- “Patients with inoperable, locally recurrent, or metastatic anal cancer have historically faced poor 5-year survival rates and limited treatment options,” said Marwan Fakih, MD, of City of Hope in Duarte, California, in a statement from drugmaker Incyte. “This approval marks an important advancement as it makes a new treatment approach available for this challenging disease.”
From the public health and medical research front,
- The Wall Street Journal tells us,
- “Health and Human Services Secretary Robert F. Kennedy Jr. has made combating chronic diseasea rallying cry as he looks to overhaul the health department and “Make America Healthy Again.”
- “So how healthy is America, historically? It isn’t that we used to be healthier, data show, but the biggest threats have changed.
- “The deadliest scourges in the U.S. were once infectious, with influenza and tuberculosis topping the list at the start of the 20th century. Better sanitation and advances in antibiotics and vaccines muzzled them, transforming Americans’ well-being. Medical innovations and antismoking campaigns then spurred decades of progress against heart disease and cancer.
- “But chronic diseases, persistent or long-lasting health conditions, are undermining that momentum, contributing to our stalled life expectancy over the past decade that trails behind that of other wealthy nations.
- “Much of the gap in life expectancy is due to deaths among working-age adults, says Dr. Steven Woolf, a life-expectancy researcher at the Virginia Commonwealth University.
- “Americans die earlier and are sicker than people in other high-income countries,” he said. “This has been true for a long time, and the trend is getting worse.”
- Health Day informs us,
- “More U.S. teenagers are getting weight-loss surgery, despite the discovery of new drugs like Ozempic/Wegovy that help people drop pounds surgery-free, a new study says.
- “Weight loss surgeries for teens increased 15% between 2021 and 2023, researchers reported earlier this month in The Journal of Pediatrics.
- “Further, much of the increase in weight-loss surgery is due to its increased popularity among Hispanic and Black teenagers, groups disproportionately affected by severe obesity compared to white teens, researchers said.
- “The number of U.S. adolescents having access to this treatment that we know is safe and effective is the highest it’s ever been, and hopefully it’s the start of a positive weight loss journey that will get them to better health,” lead researcher Sarah Messiah, director of the Child and Adolescent Population Health Program at UT Southwestern Medical Center, said in a news release.”
- Per Beckers Hospital Review,
- “Adult patients taking Wegovy saw a reduced risk of experiencing a major adverse cardiovascular event within the first three months of treatment, according to a secondary analysis of the drug’s clinical trial data, presented May 12 at the European Congress on Obesity.”
- Very good news from an NIH news release,
- “A research team supported by the National Institutes of Health (NIH) has developed and safely delivered a personalized gene editing therapy to treat an infant with a life-threatening, incurable genetic disease. The infant, who was diagnosed with the rare condition carbamoyl phosphate synthetase 1 (CPS1) deficiency shortly after birth, has responded positively to the treatment. The process, from diagnosis to treatment, took only six months and marks the first time the technology has been successfully deployed to treat a human patient. The technology used in this study was developed using a platform that could be tweaked to treat a wide range of genetic disorders and opens the possibility of creating personalized treatments in other parts of the body.
- “A team of researchers at the Children’s Hospital of Philadelphia (CHOP) and the Perelman School of Medicine at the University of Pennsylvania (Penn) developed the customized therapy using the gene-editing platform CRISPR. They corrected a specific gene mutation in the baby’s liver cells that led to the disorder. CRISPR is an advanced gene editing technology that enables precise changes to DNA inside living cells. This is the first known case of a personalized CRISPR-based medicine administered to a single patient and was carefully designed to target non-reproductive cells so changes would only affect the patient.
- “As a platform, gene editing — built on reusable components and rapid customization — promises a new era of precision medicine for hundreds of rare diseases, bringing life-changing therapies to patients when timing matters most: Early, fast, and tailored to the individual,” said Joni L. Rutter, Ph.D., director of NIH’s National Center for Advancing Translational Sciences (NCATS).”
- BioPharma Dive adds,
- “We are still in very early days,” said Rebecca Ahrens-Nicklas, an assistant professor of pediatrics at the University of Pennsylvania and study author. Doctors will monitor KJ’s progress and are considering other ways to evaluate the therapy’s effects without a biopsy.
- “Yet the findings could carry important implications for drug research. There are more than 7,000 rare diseases, many of which are so uncommon they’re unlikely to be profitable for any companies that develop treatments for them. Gene editing could be a powerful solution, but an expensive development path and slim sales prospects make such medicines tough investment propositions. A large number of biotechnology firms pursuing gene editing are struggling to survive.”
- Here is a link to the All of Us Research Project’s Medical Minutes.
- Per MedPage Today,
- “First-line treatment with nivolumab (Opdivo) and ipilimumab (Yervoy) significantly improved survival compared with lenvatinib (Lenvima) or sorafenib (Nexavar) for patients with unresectable hepatocellular carcinoma (HCC), the randomized phase III CheckMate 9DW trial showed.
- “Of more than 600 patients, median overall survival (OS) was 23.7 months with the PD-1 inhibitor and CTLA-4 inhibitor combination versus 20.6 months with single-agent tyrosine kinase inhibitors (HR 0.79, 95% CI 0.65-0.96, P=0.018), reported Peter R. Galle, MD, of the University Medical Center in Mainz, Germany, and colleagues.
- “Respective OS rates were 49% versus 39% at 24 months and 38% versus 24% at 36 months, they wrote in The Lancet.
- “The overall survival rates “are the longest and highest reported for the approved systemic treatments in this setting,” wrote Galle and colleagues, adding that the results “support nivolumab plus ipilimumab as a first-line treatment” in unresectable HCC.
- “Results of this trial led to the recent FDA approval of the combination as first-line treatment for adults with unresectable or metastatic HCC.”
- Per Fierce Pharma,
- “Merck’s Keytruda, with more than 40 approved indications, hasn’t yet been able to crack specifically into ovarian cancer. But with promising early results from a phase 3 study in certain patients, the checkpoint inhibitor may have found its place.
- “At a pre-specified interim analysis of Merck’s phase 3 Keynote-B96 trial, which is testing Keytruda plus chemotherapy with or without Roche’s Avastin in patients with platinum-resistant recurrent ovarian cancer, the drug showed “statistically significant and clinically meaningful” improvements in progression-free survival regardless of patients’ PD-L1 status, Merck reported on Thursday.
- “The trial compared the Keytruda regimen against placebo and chemotherapy, again with or without Avastin.”
- HHS’s AHRQ released a systematic review finding
- “No completed studies show if blood-based, multicancer screening tests help people compared with no screening or standard single-cancer screenings. We do not know if these tests save lives, reduce advanced cancers, or improve quality of life.
- “We found 20 studies covering 109,177 people that tested how accurate 19 different multicancer screening tests were. Thirteen of these studies had serious flaws in how they were conducted.
- “Accuracy varied widely based on:
- “What the tests measured and how researchers analyzed it,
- “How many and which types of cancers researchers tried to find,
- “Which types of people were tested, and
- “How the studies were designed.
- “We graded the strength of evidence for accuracy as insufficient, meaning we cannot draw firm conclusions.
- “We only found one study reporting on potential harms from multicancer screening tests. We graded the strength of evidence as insufficient for harms based on this single study.
- “Studies that will be completed in the next 2 to 4 years may give more information about whether multicancer screening tests work and whether they have harms.”
From the U.S. healthcare business front,
- Modern Healthcare reports,
- “Higher patient volumes were not enough to keep CommonSpirit Health in the black during its latest quarter.
- “Patient volumes soared across the country over the past couple of years due to a rebound in demand after the COVID-19 pandemic and overall population growth in fast-growing markets.
- “The trend largely boosted net patient revenue and helped pad bottom lines for many health systems. Volume growth is one part of CommonSpirit’s strategy to improve operating performance.
- “However, this year may bring a more complicated dynamic, given continued inflation, tariffs and federal funding uncertainty weighing on hospital finances.
- “Chicago-based CommonSpirit recorded a $42 million net loss in its third quarter, compared with $282 million in net income a year ago, according to financial documents published Thursday. Results are not adjusted for the California provider fee program, which would add supplemental payments if approved by the Centers for Medicare and Medicaid Services.
- “CommonSpirit said its financial results were impacted by expenses increasing at a faster rate than revenue, despite strong volumes, lower lengths of stay and higher productivity levels.”
- Beckers Hospital Review lets us know,
- “Texas Rural Hospital in Cleveland is set to reopen within the next week after it abruptly closed its doors the week of May 12 due to funding shortages, KIAH reported May 15.
- “The hospital’s lease agreement with Cleveland-based Emergency Hospital Systems, a community emergency hospital system, ended in March 2025. It then gained new ownership under HealCrest Network, a spokesperson for EHS said in a May 14 statement shared with Becker’s.
- “Hospital employees told KIAH that they did not receive pay on May 9; however, the hospital said it plans to repay them in the coming days.”
- and
- [Another article shows] “the adjusted expenses per inpatient day in 2023 for nonprofit, for-profit, and government hospitals in every U.S. state, based on the latest estimates provided by Kaiser State Health Facts.
- “The figures are based on information from the 2023 American Hospital Association Annual Survey. They are an estimate of the expenses incurred in a day of inpatient care and have been adjusted upward to reflect an estimate of outpatient service volumes, according to the KFF.
- “The foundation notes the figures are “only an estimate of expenses incurred by the hospital” for one day of inpatient care and do not substitute actual charges or reimbursement for care provided.
- “To see how expenses compare to one year prior, find 2022’s adjusted expenses per inpatient day here.
- National average
- Nonprofit hospitals: $3,288
- For-profit hospitals: $2,529
- State/local government hospitals: $2,857
- Per a press release,
- “Blue Cross and Blue Shield of Massachusetts, Inc. and Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc. (together, Blue cross) today reported a combined after-tax first quarter net income of $37 million on revenue of $2.6 billion (1.4% net margin). These results reflect an operating and other loss of $9.8 million (-0.4% operating margin) and investment income of $46.8 million.
- “The big story is that spending on medical and pharmacy services for our members remains elevated, at near historic highs,” said Chief Financial Officer Ruby Kam. “Two notable callouts in the first quarter involve higher spending due to the difficult flu season as well as the continued impact of high-cost GLP-1 medications.” Kam said the company projects operating and net losses for full-year 2025 and has implemented a comprehensive plan to improve its financial results. Last year, the company posted the worst operating loss in its 87-year history.
- “Blue Cross is the leading private health plan in Massachusetts with 3 million members.”
- Fierce Healthcare points out,
- “Earlier this month, pharmacy chain Rite Aid filed bankruptcy for the second time in less than two years, revealing that it would seek buyers for its retail locations.
- “In the Pacific Northwest, it’s garnering interest from pharmacy rival CVS Health, according to a report in Bloomberg. Rite Aid CEO Matthew Schroeder told employees on Thursday that CVS had made a bid on a large number of stores in Washington, Oregon and Idaho along with patient prescription data, according to a recording reviewed by the outlet.
- “If a deal were to go through, it would give CVS greater reach in a region where its presence is currently smaller, per the article.
- “Schroeder said that Rite Aid has also received bids on some of its assets from multiple other pharmacy groups, including Walgreens, Albertsons, Kroger and Giant Eagle, Bloomberg reported.”
- Per an Institute for Clinical and Economic Research news release,
- “Institute for Clinical and Economic Review Publishes Final Evidence Report on Treatment for Retinitis Pigmentosa. Independent appraisal committee voted that current evidence is adequate to demonstrate a net health benefit of sonpiretigene isteparvovec compared to usual care.”
- “Institute for Clinical and Economic Review Publishes Final Evidence Report on Treatment for Retinitis Pigmentosa. Independent appraisal committee voted that current evidence is adequate to demonstrate a net health benefit of sonpiretigene isteparvovec compared to usual care.”