Monday report

From Washington, DC,

  • The Washington Post lets us know,
    • “The White House will make the case Monday to Congress — and to voters — that it has developed a strategy to address frequent frustrations involving U.S. medical care, such as too few physicians and too much paperwork.
    • “The Trump administration casts its physician-focused agenda as a fix for a strained health care system — pointing to a $50 billion funding program for rural health it contends will boost the number of doctors in remote areas, efforts to reduce payment distortions that favor hospitals rather than doctors, and regulatory changes intended to speed insurance approvals for tests and follow-up care.
    • “Together, these reforms will enable faster, more affordable, and higher-quality physician services for Americans,” the White House writes in the Economic Report of the President [WhiteHouse.gov link], an annual document previewed with The Washington Post and set to be transmitted to Congress on Monday.
    • “The economic report, which does not offer new proposals, is best understood as a distillation of White House economists’ thinking ahead of this year’s midterm elections, in which voters’ frustrations regarding health care costs and access are set to play a central role. Past administrations have often used the report, which is written by the president’s Council of Economic Advisers, as a messaging document to rally support for their initiatives. This year’s report addresses health care affordability, a key focus for President Donald Trump and his advisers, and says it is working to “unleash” more competition in health care markets to lower costs and improve quality.”
  • Beckers Hospital Review reports,
    • “CMS on April 10 proposed a 2.4% pay increase for hospitals under the fiscal 2027 Inpatient Prospective Payment System, but hospitals are concerned that the update does not keep pace with the mounting financial challenges.
    • “CMS has proposed another inadequate update to inpatient payment rates, another extremely high productivity cut, and reductions to disproportionate share payments — in the face of rising need for care and higher uninsured rates,” Ashley Thompson, the American Hospital Association’s vice president of public policy analysis and development, said in an April 10 statement. 
    • “Beth Feldpush, America’s Essential Hospitals’ senior vice president of policy and advocacy told Becker’s in an April 11 statement that the proposed DSH payment cuts “fails to acknowledge the growing number of uninsured individuals due to recent Congressional actions.” 
    • ‘Charlene McDonald, president and CEO of the Federation of American Hospitals, said in an April 10 statement that CMS’ proposal is a step in the right direction, but added it “does not negate the compounding effects of rising inflation, record levels of uncompensated care and a growing uninsured population.”
    • “National hospital group leaders also raised concerns about another aspect of the proposal: the introduction of the first mandatory nationwide episode-based payment model.”
  • Fierce Healthcare informs us,
    • “The Centers for Medicare and Medicaid Services picked 150 digital health companies and healthcare providers to participate in the launch of its tech-enabled chronic care model.
    • “The Center for Medicare and Medicaid Innovation (CMMI) announced in December the Advancing Chronic Care with Effective Scalable Solutions (ACCESS) Model as a 10-year payment program to encourage the use of technology to treat chronic diseases. CMS aims for the ACCESS Model to provide stable, recurring payments for technology used to treat diabetes, hypertension, chronic kidney disease, obesity, depression and anxiety. The model will help pay for telehealth software, wearables and wellness apps that address the conditions.
    • “The CMMI plans to use outcome-aligned payments to cover the cost of technology for Medicare providers if a patient with a qualifying chronic condition achieves clinically significant outcomes, such as lowering their blood pressure.” 
  • Citeline points out,
    • An April 1, 2026, proposal [Federal Register link] from the US Treasury Department would allow whistleblowers who alert the government to certain financial crimes to collect 10%-30% of any monetary penalties collected, creating a new risk for healthcare firms – especially those with overseas business partners. The public comment period ends on June 1, 2026.

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “For the first time, the FDA has approved generics for AstraZeneca’s Type 2 diabetes blockbuster Farxiga. The U.S. regulator has given thumbs up to 14 companies, including Teva, Sandoz and a host of Indian drugmakers including Aurobindo, Biocon, Cipla, Lupin and Zydus to produce 5 mg and 10 mg tablets of dapagliflozin.
    • “The treatment is indicated for glycemic control and to reduce the risk of hospitalization for heart failure for those with Type 2 diabetes who also have established cardiovascular disease or multiple cardiovascular risk factors.Farxiga generated sales of $8.5 billion last year, including $1.7 billion in the U.S.
    • “The FDA originally approved the SGLT2 inhibitor in 2014. Generic versions of Farxiga became available (PDF) in the U.K. and Japan in the second half of last year.”
  • and
    • “From a negative phase 3 readout and a seemingly tightening regulatory climate to a grueling three-month review extension, the path for Travere Therapeutics in its first-in-disease bid was anything but certain. Yet, the company has defied the odds, securing Filspari a landmark FDA approval in focal segmental glomerulosclerosis (FSGS) and delivering the first treatment for the rare kidney disease.
    • “Monday’s FDA approval makes Filspari the first therapy specifically indicated for FSGS, a condition that represents a $1 billion-plus sales opportunity, according to Leerink Partners analysts. The drug was originally approved in 2023 for the treatment of IgA nephropathy, another kidney disease.
    • “FSGS is estimated to affect more than 40,000 patients in the U.S. The disorder is characterized by scarring in the kidney’s filtering units as protein keeps leaking into the urine, often leading to further disease progression and kidney failure, sometimes quite rapidly.” 
  • Cardiovascular Business relates,
    • “Anumana, a Massachusetts-based artificial intelligence (AI) company co-founded by nference and Mayo Clinic, has received U.S. Food and Drug Administration (FDA) clearance for a new algorithm designed to detect signs of cardiac amyloidosis (CA). This represents Anumana’s second FDA clearance in just two weeks, highlighting the company’s growing impact in the world of cardiovascular care. 
    • “CA is a life-threatening condition that often leads to heart failure complications, but it remains critically underdiagnosed. Anumana sees this clearance as a way to help care teams identify CA early so patients can receive timely treatment.
    • “The newly cleared algorithm, which previously received the FDA’s breakthrough device designation, was designed to evaluate standard 12-lead electrocardiograms (ECGs) and flag patients at increased risk of CA. 
    • “Each of our FDA-cleared algorithms addresses a specific and frequently missed cardiovascular condition, and cardiac amyloidosis represents an important addition to that portfolio,” Maulik Nanavaty, CEO of Anumana, said in a prepared statement. “The more conditions we can identify from a single ECG, the more valuable the test becomes in clinical practice. That’s what Anumana is working toward with each new clearance as we continue to advance our rigorous clinical evidence approach.”

From the census front,

  • The Wall Street Journal reports,
    • “The first of the youth-obsessed baby boomers turn 80 this year, including President Trump, and they want to shake up old age.
    • “Having reached octogenarian levels, a generation that shaped much of our past is shaping the future of aging for themselves and those who follow. They want better healthcare and housing, cures for dementia and a say in when to die. New professions and products will appear. Their massive spending will shift and innovators will follow.
    • “They are reinventing old age,” says Joseph Coughlin, director of the Massachusetts Institute of Technology AgeLab. Unlike the patient Silent Generation, boomers had high expectations and used their sheer numbers as well as financial and political clout to make them happen, which isn’t necessarily a bad thing.
    • “If you don’t have expectations of getting better, then you simply become satisfied with what is,” says Coughlin.”

From the public health and medical / Rx research front,

  • NBC News reports,
    • “Protein-hungry shoppers are buying more meat with their health top of mind. Health experts, however, wish they’d think beyond the butcher counter.” * * *
    • “Meat is indeed packed with protein, but it comes with some well-established health drawbacks.
    • “Saturated fat we’ve known about for decades,” said Dr. Sarah C. Hull, a cardiologist at Yale Medicine. It’s common in red meat and contributes to increasing LDL cholesterol levels, hardening the blood vessels and, in turn, raising the risk of heart attack or stroke.” * * *
    • “Hull said that many common plant-based proteins are particularly high in fiber, which 95% of Americans don’t get enough of, and they’re generally associated with better overall health outcomes than animal proteins. Her research suggests that increased consumption of certain plant-derived nutrients may help counter some negative effects of red meat and ultra-processed foods.”
  • Health Day relates,
    • “Influenza vaccination may offer cardiovascular protection even when it does not prevent infection, according to a study published online April 2 in Eurosurveillance.” * * *
    • “Hospital admissions for heart attack and stroke were more frequent in the first week after testing positive for influenza than during any other period in the year before and after their test,” the authors write. “This increased risk was about half as high among people who tested positive for influenza but had received the influenza vaccine that season.”
  • and
    • “Children with ADHD are more apt to have a bright future if they’re diagnosed in their early elementary years rather than as high schoolers, a new study says.
    • “Kids diagnosed with ADHD at an earlier age are more likely to have better grades and go on to college, researchers reported April 8 in JAMA Psychiatry. They’re also less likely to drop out of school.
    • “ADHD diagnosis during the first years of school was associated with better school performance, more academic track choices and lower probability of school dropout,” concluded the research team led by Lotta Volotinen, a doctoral researcher at the University of Helsinki in Finland.
    • “The findings support the recommendations for earlier diagnosis, and screening for ADHD before age 12 years should be considered,” the team wrote.”
  • The American Medical Association lets us know “what doctors wish patients knew about managing food allergies.”
    • Once a food allergy is diagnosed, learning how to avoid triggers, recognize warning signs and when to seek medical care are key. Two physicians share more.
  • Per Cardiology Advisor,
    • “Maternal stroke is associated with significantly higher rates of maternal mortality and severe delivery complications, including cardiac arrest and acute renal failure.”
  • Per Pulmonology Advisor,
    • “The increased risk for asthma attacks among those using marijuana was consistent regardless of whether individuals vaped or smoked cannabis or did both.”
  • Per an Oregon State University news release,
    • “Researchers at Oregon Health & Science University have uncovered a key reason why immunotherapy has largely failed in pancreatic cancer — and identified a promising strategy to overcome that resistance. 
    • “The study, published in the journal Immunity, shows that pancreatic tumors actively reshape their immune environment by co‑opting regulatory immune cells that normally shut down tumor-killing cells. By reprogramming those cells, the research reveals a potential pathway to make immunotherapy effective against one of the deadliest and most treatment‑resistant cancers. 
    • “Pancreatic cancer is incredibly resistant to most therapies,” said the study’s senior author, Katelyn Byrne, Ph.D., assistant professor of cell, developmental and cancer biology in the OHSU School of Medicine and member of the OHSU Brenden‑Colson Center for Pancreatic Care. “Even when we know the immune system is capable of long‑lasting protection, it’s been very difficult to get that response to work in this disease.” 
    • “In the new study, Byrne and team tested an experimental immunotherapy in mouse models known as agonistic CD40, which works differently from standard checkpoint inhibitors. Rather than targeting a single immune signal, the therapy broadly activates the immune response upstream. 
    • “Byrne said the researchers were surprised to find out that activating the immune system this way didn’t just stimulate tumor‑killing cells — it also reprogrammed regulatory T cells, converting them from immune suppressors into cells that support anti‑tumor activity. 
    • “We didn’t expect this,” Byrne said. “The therapy doesn’t directly target Tregs, but as a secondary effect of turning on the immune response, those Tregs changed their behavior. Cells that were shutting down the immune reaction suddenly started supporting tumor killing.” 
    • “The team’s findings help explain one reason why many immunotherapies haven’t worked in pancreatic cancer and point to a possible solution: Treatments may need to both turn on the immune system and overcome the tumor’s own ability to shut it down.” 
  • Per an NIH news release,
    • “A National Institutes of Health (NIH)-funded research team has discovered an enhanced CRISPR gene-editing system that could enable targeted delivery inside the human body — a key step toward broader clinical use. Researchers identified a naturally occurring enzyme, Al3Cas12f, that is small enough to fit into adeno-associated virus vectors, a leading targeted delivery method for gene therapies. They then engineered an enhanced version that dramatically improved gene-editing performance in human cells. 
    • “The advance addresses a major limitation in CRISPR technology. Commonly used gene-editing proteins are too large for targeted delivery systems, restricting clinical applications to cells modified outside the body, such as blood and bone marrow. 
    • “Smart delivery of gene editing systems is a powerful notion with broad clinical implications, and this basic science finding takes us a significant step toward that future,” said Erica Brown, Ph.D., acting director of NIH’s National Institute of General Medical Sciences (NIGMS).” 
  • BioPharma Dive adds,
    • “Revolution Medicines said Monday its experimental pancreatic cancer drug hit every goal at an early checkpoint in a Phase 3 trial, helping people who got it live nearly twice as long as those who got standard chemotherapy.
    • “Enrollees who got daraxonrasib lived a median of 13.2 months after treatment, compared with 6.7 months for those who got chemo, a finding that equates to a 60% reduction in the risk of death among those who got the experimental drug. Daraxonrasib achieved its other objectives at an interim look at the results, findings so striking that the company ended the trial early. Revolution enrolled people whose metastatic pancreatic cancer had returned after an earlier treatment.
    • “The Food and Drug Administration has already awarded daraxonrasib a “national priority” voucher that could help Revolution gain an approval within weeks of an official submission. Revolution shares rose nearly 40% in early trading, adding $7 billion to the company’s already hefty valuation.”
  • BioPharma Dive also informs us,
    • “An experimental therapy from Allogene helped eliminate signs of cancer better than standard treatment in a Phase 3 trial in first-line large B-cell lymphoma, results suggesting the biotechnology company may have found a role to use donor-derived cell therapy against the deadly blood cancer.  
    • “After 45 days of treatment, seven of the 12 patients given Allogene’s therapy in the study were negative for “minimal residual disease,” meaning that diagnostic tests could no longer detect signs of cancer. By comparison, only 2 of 12 placebo recipients hit that mark, a roughly 42-percentage-point difference that clears an important bar published literature has suggested is crucial for delaying a relapse. 
    • “The results come from an early “futility” analysis. Allogene is enrolling 220 people in the study and expects to report in 2027 results showing whether treatment staved off cancer’s return.
  • and
    • “In experimental drug from Spyre Therapeutics helped lower signs of disease activity and improve remission rates in a Phase 2 study of people with ulcerative colitis. 
    • After 12 weeks of treatment, patients who received “SPY001” in the trial had a statistically significant, 9.2-point reduction on a scoring system that assesses the severity of their disease, meeting the study’s primary objective. Notably, treatment was also associated with a 40% remission rate and a 51% improvement on endoscopic imaging. One severe adverse event was reported — chest pain in a 68-year-old male with a history of cardiovascular disease — but was deemed unrelated to treatment.
    • Spyre said the findings were “clinically meaningful” and support SPY001’s “best-in-class profile.” The drug is one of multiple therapies the company is evaluating in Phase 2 trials in inflammatory bowel disease. Proof-of-concept data for two other therapies in the trial are expected later this year. Data from a placebo-controlled portion of the study are on track for 2027.” 
  • Per Fierce Pharma,
    • “Eli Lilly has chalked up another victory in the chronic lymphocytic leukemia (CLL) space, as its BTK inhibitor Jaypirca delivered its fourth positive phase 3 readout in the blood cancer. 
    • “Monday, Lilly said its phase 3 Bruin CLL-322 trial in patients with previously treated CLL or small lymphocytic lymphoma (SLL) has met its primary endpoint. In an industry first, the study showed that adding Jaypirca to a fixed-duration regimen of venetoclax and rituximab significantly extended progression-free survival (PFS) compared with the standard combo alone. 
    • “As Lilly pointed out, Bruin CLL-322 is the first phase 3 in CLL to utilize and outperform a venetoclax-based regimen. Roche and AbbVie sell venetoclax, an oral BCL-2 inhibitor, under the brand name Venclexta.” 

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

  • Beckers Payer Issues reports,
    • “Houston-based Memorial Hermann Health System and BCBS Texas agreed on a contract April 11, bringing the health system back in network.
    • “The agreement ensures “access to quality care at cost-effective prices,” BCBS Texas said in an April 13 statement shared with Becker’s. It covers both commercial and Medicare Advantage members. The previous contract expired April 1, affecting commercial members. The health system had beenout of network for Medicare Advantage plans since Jan. 1.”
  • Fierce Healthcare offers a look at how Evernorth’s new Delaware specialty pharmacy facility highlights a broader care coordination approach.
  • Beckers Hospital Reports ranks 83 health systems by their most recent revenue.
    • “Revenue growth continued across the hospital industry in 2025, with many of the nation’s largest health systems posting mid- to high-single-digit gains fueled by stronger patient volumes, improved payment rates and the expansion of ambulatory and pharmacy operations. 
    • “But the gains were far from uniform. Some systems grew revenue by double digits through mergers, acquisitions and new payer arrangements, while others saw declines as they shed hospitals and restructured their portfolios.”
  • and tells us,
    • “The world’s two main GLP-1 drug manufacturers, Eli Lilly and Novo Nordisk, are taking different approaches with rolling out their recently approved GLP-1 pills for weight loss. 
    • “Two oral GLP-1s, two very different commercial strategies. Health systems operating metabolic programs or making formulary decisions need to understand both.
    • “While both companies offer their recently approved GLP-1 pills through pharmacies and direct-to-consumer platforms that circumvent pharmacy benefit managers, they are diverging in other routes. 
    • “Eli Lilly is betting on retail and digital access, as it’s offering its weight loss GLP-1 pill through GoodRx, telehealth firm Ro and same-day delivery with Amazon Pharmacy
    • “By contrast, Novo Nordisk launched a Wegovy subscription program through WeightWatchers, LifeMD, Ro and Hims & Hers — with which the drugmaker previously had a strained relationship. With the 12-month subscription plan, Novo Nordisk said patients can save up to $600 per year on the Wegovy pill.” 
  • and informs us,
    • “Large language models may help identify drug safety signals in clinical notes, though their performance remains below thresholds required for clinical decision support.
    • “Researchers evaluated three models — GPT-3.5, GPT-4 and GPT-4o — using clinical notes from 100 patients at Nashville, Tenn.-based Vanderbilt Health, 70 patients at the University of California—San Francisco and 272 patients from seven Roche-sponsored trials, according to an April 6 Vanderbilt news release.
    • “For detecting immune-related adverse events at the patient level, GPT-4o achieved F1 scores of 56%, 66% and 62% across the respective datasets. The F1 score reflects how well a model balances correctly identifying real safety issues while avoiding false alarms. At the individual note level, the model reached an average F1 score of 57% across 667 notes.
    • “An F1 score of 90% or more is considered excellent, while 80% or higher may support clinical decision-making.”
  • STAT News points out,
    • “Every day, more than 40 million people ask ChatGPT about health care, according to OpenAI. They’re asking questions about diet, exercise, insurance — and in some cases, serious symptoms that would typically get discussed on a 911 call or in a doctor’s office.
    • “For some health systems, that’s creating an imperative. A small number of hospitals are trying to recapture some of those clinical conversations from commercial large language models like ChatGPT, Claude, and Gemini. They’re implementing their own patient-facing chatbots, ones that draw directly from their existing medical records and can funnel patients toward care in their own system. 
    • “Hartford HealthCare this week will launch PatientGPT, a chatbot engineered by clinical AI company K Health, to its patients in Connecticut. Two health systems — California-based Sutter Health and Reid Health, serving Indiana and Ohio — have announced pilot versions of Emmie, the chatbot built by medical record mammoth Epic. The list is likely to grow rapidly.
    • “Health systems need to do this, either through a vendor or building it themselves,” said Mount Sinai chief AI officer Girish Nadkarni, the senior author of a recent study that found ChatGPT Health missed high-risk emergencies when used to triage patients.”
  • The Wall Street Journal cautions,
    • “The artificial intelligence gold rush is rapidly drying up the supply of computing power, leading to product issues and reliability problems.
    • “Anthropic experiences frequent outages and limits user token usage, while OpenAI scrapped its Sora app to free up compute.
    • “CoreWeave raised prices over 20% and extended contracts, as spot-market Nvidia GPU rental costs rose 48% in two months.” * * *
    • “All of it points to a classic problem that has popped up in technology booms throughout history, from the 19th-century railroad expansion to the telecom and internet explosion of the early 2000s. Demand is growing far faster than companies are able to access resources and build out infrastructure. Historically, price increases have been among the only ways to address a supply crunch, but such a move could be perilous for frontier AI companies, which are in a ferocious competition to gain users.”
  • Per MedTech Dive,
    • “Stryker said Monday that it has agreed to buy intravascular lithotripsy firm Amplitude Vascular Systems. The companies did not disclose the terms of the acquisition. 
    • “Intravascular lithotripsy is a procedure to treat artery disease. Boston-based Amplitude Vascular Systems, or AVS, uses pressure waves generated by carbon dioxide through a balloon catheter to break up calcified plaque.
    • “The acquisition is expected to bolster Stryker’s peripheral vascular portfolio once AVS’ device is cleared in key markets.”
  • and
    • “GE HealthCare has provided an update on the integration of its bkActiv intraoperative ultrasound technology with Medtronic’s Stealth AXiS surgical navigation system.
    • “The integrated product is now available commercially, GE HealthCare said Thursday. Medtronic said it had integrated bkActiv into Stealth AXiS when the surgical system received regulatory clearance last month.
    • “Integrating the technologies gives surgeons real-time ultrasound images, helping them to assess mid-procedure anatomy changes that could affect the preoperative plan.”

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