Friday report

OPM

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Federal News Network reports
    • “Nearly 12,000 new retirement claims entered the Office of Personnel Management’s systems last month. Coupled with OPM’s processing of about 17,000 retirement applications, the agency managed to reduce its inventory by several thousand claims. April was the first time OPM’s retirement backlog has dipped below 50,000 claims in more than five months. Currently, digital retirement claims are also being processed in about two-thirds the time of traditional paper applications.”
  • and
    • “Democrats are urging the Office of Personnel Management not to shut down the Combined Federal Campaign. In a letter to OPM this week, lawmakers warned that ending the CFC would be “disastrous” for hospitals, food banks and other organizations that receive charitable donations through the program. OPM recently decommissioned the CFC’s online donation portal, but the agency has not yet confirmed whether the program will be officially dismantled this year. CFC has been in operation since the Reagan administration, a program that lets federal employees contribute to charities around the world.”
  • The Wall Street Journal relates,
    • “The CDC is coordinating with the WHO on a hantavirus outbreak aboard the MV Hondius, despite the U.S. withdrawal from the WHO and CDC cuts.
    • “The U.S. formally withdrew from the WHO earlier this year, following President Trump’s executive order and criticism of its Covid-19 handling.
    • “The Trump administration reduced funding for CDC global health programs, shifting to a fee-for-service model for technical assistance.”
  • KFF Health offers more details on CMS’s Bridge program which will give eligible Medicare beneficiaries access to GLP-1 drugs for weight loss. The Bridge program runs from July 1. 2026, through December 31, 2027.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “President Trump has signed off on a plan to fire Food and Drug Administration Commissioner Marty Makary, according to people familiar with the matter, following a tumultuous period for the regulator that included clashes over vaping, abortion and drug policy.
    • ‘Makary, a former Johns Hopkins surgeon who became a frequent Make America Healthy Again surrogate on television news programs, is seen by other top administration leaders as struggling to manage his agency, sparring frequently with health department officials and at times with the White House. His tenure has also been dogged by the aftereffects of layoffs led by the Department of Government Efficiency and rapid turnover in the FDA’s leadership ranks. 
    • ‘He would become the latest top lieutenant fired under Health and Human Services Secretary Robert F. Kennedy Jr. since the ouster last summer of Centers for Disease Control and Prevention Director Susan Monarez and the February removal of HHS Deputy Secretary Jim O’Neill.
    • “Trump’s plan isn’t yet final and could change.”
  • The American Hospital Association News relates,
    • “The Food and Drug Administration has issued a Class I recall correction for certain Boston Scientific ACCOLADE pacemakers and cardiac resynchronization therapy pacemakers after identifying a software-related battery issue that could cause affected devices to enter Safety Mode and limit pacing functionality. The correction does not involve removing devices but requires clinicians to upgrade the pacemakers’ software to reduce the risk of premature battery depletion and early device replacement. According to the FDA, continued use of affected devices without the update could result in serious injury or death. Hospitals and clinicians are advised to review affected model and serial numbers, apply the software update during in office visits, monitor patients per manufacturer guidance and report adverse events through the FDA’s MedWatch program.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion-positive cholangiocarcinoma, an ultra-rare, aggressive cancer that forms in the bile ducts. 
    • “Bizengri is the first drug approved for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.
    • “This approval marks the seventh approval under the Commissioner’s National Priority Voucher (CNPV) pilot program.”
  • Fierce Pharma tells us,
    • “While Eisai and Biogen have already secured an FDA nod for a subcutaneous maintenance dose of their early Alzheimer’s disease drug Leqembi (lecanemab), the partners will have to wait a few months more for the regulator to weigh in on their proposed autoinjector initiation dose. 
    • “On Friday, the companies announced that the FDA has extended the review period for their application to advance their Leqembi Iqlik autoinjector as a starting dose for early Alzheimer’s patients. The three-month delay puts the FDA’s new target action date at Aug. 24, Biogen and Eisai said in a release.”
  • Beckers Hospital Review identifies seven prescription drugs now in shortage.
    • “Active drug shortages in the U.S. rose for the second consecutive quarter in 2026, reaching 223 in the first quarter, according to a recent report from the American Society of Health-System Pharmacists. Meanwhile, the FDA’s own database — which uses a narrower classification — lists 76 drugs currently in shortage, as of May 6.
    • “The database is updated daily to reflect manufacturing recoveries, regulatory actions and how shortages are classified — not solely day-to-day availability at the hospital level.”
  • Here’s a link to “Brown & Brown’s May 6, 2026, PharmaLogic® Spotlight [which] reviews evolving pharmacy dynamics and trends driving prescription drug use and cost to guide benefits decision-making.”
    • “Inside this PharmaLogic® Spotlight
      • “New Drug Approvals Influencing Benefits
      • “GLP-1 Developments
      • “Drug Importation/International Sourcing
      • “Generic and Biosimilar Use
      • “Shifts in Drug Pricing Models”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today:
    • “The amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is decreasing and has peaked in most regions of the country.
    • “Seasonal influenza activity is low.
    • “COVID-19 activity is low in most areas of the country.
    • “Nationally, wastewater activity levels for RSV, COVID-19 and influenza A are very low. Influenza B is not monitored in wastewater.”
  • The American Hospital Association News adds,
    • “The measles outbreak in Utah that began in June 2025 has grown to 638 cases as of May 5, according to the state’s Department of Health and Human Services. Of those, 441 have been reported this year. Nationally, there have been 1,842 confirmed measles cases in 2026, according to the Centers for Disease Control and Prevention. The vaccination status of 92% of cases is unvaccinated or unknown.”
  • Medscape reports,
    • “Once weekly semaglutide injections reduced alcohol consumption in patients with alcohol use disorder (AUD) and comorbid obesity.
    • “Results of the randomized controlled trial (RCT), the first, to the authors’ knowledge, to evaluate the GLP-1 receptor agonist (GLP-1RA) semaglutide in patients seeking treatment for AUD who had comorbid obesity also showed significant effects on multiple alcohol-related outcomes.
    • “These data, when added to the growing evidence, demonstrate the potential of GLP-1RAs as a novel treatment for alcohol use disorder,” the investigators, led by Mette Kruse Klausen, MD, Copenhagen University Hospital in Copenhagen, Denmark, wrote.
    • “However,” they added, “corroboration with larger RCTs in nonobese patients is needed to address its generalizability.”
  • and
    • “GLP-1 receptor agonists may alter absorption of oral medications due to delayed gastric emptying, affecting drug levels and efficacy. Notable interactions include oral contraceptives, levothyroxine, and dabigatran, necessitating careful monitoring and potential dose adjustments.”
  • Health Day relates,
    • “People recovering from surgery have an easy way to boost their odds of a successful recuperation — take a stroll.
    • “Every extra 1,000 steps a patient takes daily after surgery lowers their odds of complications, researchers reported May 6 in the Journal of the American College of Surgeons.
    • “This link between extra steps and better recovery applied across different types of procedures regardless of the patients’ overall health, researchers found.
    • “Researchers discovered this after tracking nearly 2,000 people undergoing inpatient surgery who wore activity trackers while undergoing inpatient surgery.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “UnitedHealthcare has begun paying some commercial claims instantly, bypassing the standard three to five day window associated with traditional ACH transactions, the insurer said May 4.
    • “Under the new system, eligible commercial claims payments are deposited immediately into providers’ bank accounts, with remittance data routed through clearinghouses to providers’ tax identification numbers.
    • “UnitedHealthcare did not specify which claims or plan types qualify for real-time payment. The payments are not processed through Optum and will not appear on the Optum Pay platform.
    • “Providers do not need to take action to receive the payments, but UnitedHealthcare said some may need to update reconciliation workflows.” 
  • Kaufmann Hall notes,
    • “Americans are increasingly making serious trade-offs that impact their health and daily lives to afford health expenses, according to a recent report from West Health-Gallup Center on Healthcare in America. About 30% of insured and 62% of uninsured Americans—across income brackets—have made at least one or more difficult trade-off: prolonging their prescription, skipping a meal, cutting back on utilities or borrowing money. A third reported postponing vacations and surgical and medical treatment alike. These trade-offs are not “nice to have.” Not taking medication as prescribed, skipping meals, cutting back on utilities especially during extreme weather, and delaying surgical and medical treatment carry serious medical risk for harm that leads to increased ED visits, readmissions, and other avoidable costly care that may impact hospitals and health systems.
  • MedCity News relates,
    • “As patient payment responsibility grows and becomes a larger part of the overall care experience, payment decisions need more visibility across the organization, not just in finance or IT. 
    • “Healthcare organizations should begin with a practical review that includes: which payment methods are accepted at every point of care, whether FSA, HSA, and Medicare card configurations are validated across systems, where declines are occurring and why, and how long it takes patients to move from statement to payment. 
    • “Payment friction isn’t always obvious. It shows up in extended accounts receivable timelines, increased billing inquiries, and patients who delay payment – not because they’re unwilling to pay, but because the process made it harder than it needed to be. As patients become responsible for more of the bill, consistency matters. The payment process should be predictable across settings and straightforward to navigate.
    • “Payment systems may not determine whether care is delivered. But as more financial responsibility shifts to patients, they increasingly influence how that care is experienced.”
  • Modern Healthcare tells us,
    • “Sanford Health is looking to expand its Minnesota network in one of the state’s fastest-growing regions. 
    • “Sanford and North Memorial Health signed a definitive agreement to add North Memorial’s two hospitals and affiliated facilities in northwest Minneapolis to Sanford’s 58-hospital footprint, according to a Friday news release. * * *
    • “Under the agreement, Sanford pledged to update emergency services at the financially strained safety-net hospital North Memorial Health Robbinsdale. Sanford also said it plans to help double the size of North Memorial Health Maple Grove Hospital by expanding emergency care, inpatient services, surgeries and labor and delivery care. 
    • “The proposed transaction is expected to close this year, pending customary regulatory approvals.”
  • Beckers Hospital Review points out,
    • “Between the fourth quarters of 2024 and 2025, emergency department length of stay decreased 13.4% even as volumes grew 4.2% and patient acuity rose, according to a May 6 report.
    • “The report is from Sg2, a healthcare analytics and consulting company at Vizient. Through its System of CARE Scorecard, Vizient measures hospital utilization, access, safety and cost efficiency each quarter. Its latest scorecard compared the fourth quarters of 2025 and 2024 for care coordination. 
    • “On a rolling year-over-year measure, ED length of stay declined 15.2% and volume increased 4.3%, according to the report. Vizient researchers hypothesized that improvements in throughput, shifting trends in patient mix or a combination of the two could be account for these findings.” 
  • Fierce Healthcare informs us,
    • “Amazon Pharmacy will make Novo Nordisk’s Ozempic pill available for home delivery, the company announced Thursday.
    • “Per the announcement, Amazon customers will be able to secure the oral GLP-1 medication via same-day delivery or pickup within minutes at its kiosks in short order. The drug, which is approved to manage blood sugar in individuals with type 2 diabetes, was originally sold as Rybelsus but was recently rebranded to Ozempic by Novo.
    • “Amazon said that making the drug available via its pharmacy will address “a critical access gap for the more than 36 million Americans living with type 2 diabetes.”
    • “Individuals with a prescription for oral Ozempic can order the drug through Amazon Pharmacy as well as access key availability and transparent pricing data, even if they are not Prime members, the company said. Pricing is as low as $25 per month with insurance coverage.”
  • The Wall Street Journal lets us know,
    • “Sandoz Group plans to launch its generic semaglutide in Canada and Brazil this year, following patent expiration in several countries.
    • “Sandoz Chief Executive Richard Saynor stated the generic weight-loss drug market size is unknown, with initial years focused on supply.
    • “Analysts forecast Sandoz’s generic semaglutide sales to reach $742.6 million in 2035, as the overall market expands.”
  • Per MedTech Dive,
    • “Stryker has completed the acquisition of Amplitude Vascular Systems, less than a month after the deal was announced. The financial terms were not disclosed.
    • “Amplitude has developed the Pulse intravascular lithotripsy platform to treat severely calcified arterial disease. The device uses pressure waves generated by carbon dioxide and delivered through a balloon catheter to fracture the calcium and expand narrowed vessels, restoring blood flow.
    • “Stryker said adding an IVL platform will strengthen its peripheral vascular portfolio, which includes the Inari Medical clot-removal business the company acquired last year for about $4.9 billion.”

Thursday report

David Ermer–FDA, Federal employment benefits, Generative AI, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Federal News Network reports,
    • “In the coming months, the Office of Personnel Management is expected to release a reworked version of its employee viewpoint survey that’s more focused on granular data and delivering realtime feedback.
    • “OPM Director Scott Kupor said his agency has been refining the survey to focus more on micro-level questions in order to more effectively gauge employee opinion.
    • “The goal is to get to a decision on what the kind of new survey format looks like so that we have time to do something over the course of this fiscal year for sure,” Kupor told Federal News Network in an interview Wednesday.”
  • Fedweek outlines the FEHB/PSHB eligibility rules for children.
    • “Both the Federal Employees Health Benefits program and Postal Service Health Benefits program, provide for coverage of spouses and children in their self plus one and family options. While enrollment changes typically happen during the open season each autumn, there are certain life events that involve adding children—for example from self plus one to self and family on the birth or adoption of a child.
    • “In both cases, it’s important to know who qualifies for coverage as a child, and when that may end.’
  • Thompson Reuters notes,
    • “QUESTION: We recall that the Affordable Care Act (ACA) requires insured group health plans to satisfy nondiscrimination rules similar to those that apply to self-insured plans under Code § 105(h) (the eligibility and benefit tests). What is the status of those rules? Are employers that sponsor insured plans required to comply with them, and if so, when?
    • “ANSWER: Under the ACA, insured group health plans generally must satisfy the nondiscrimination rules of Code § 105(h)(2), including “rules similar to” those in Code § 105(h) regarding nondiscriminatory eligibility, nondiscriminatory benefits, and controlled groups. The Code § 105(h) rules pre-date the ACA, prohibit certain discrimination in favor of highly compensated individuals, and apply only to self-insured health plans. The ACA applied similar requirements to insured plans, other than those that provide only excepted benefits or qualify for grandfathered status.
    • “Although insured group health plans initially were required to comply with the ACA nondiscrimination rules for plan years beginning on or after September 23, 2010, the IRS announced in Notice 2011-1 that compliance is not required until the agencies issue regulations or other guidance regarding how the rules apply to insured plans. To date, the agencies have not issued such regulations or guidance, so sanctions for failure to comply do not yet apply for insured plans. Note that the Code § 105(h) nondiscrimination rules continue to apply to self-insured health plans, including those that provide excepted benefits or are grandfathered. For example, the Code § 105(h) nondiscrimination rules continue to apply to health FSAs”.
  • Per an HHS news release,
    • “Today, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced an Interim Final Rule (IFR) extending, for one-year, the compliance dates that recipients of HHS funding must meet for conforming web content and mobile applications to specific accessibility standards under Section 504 of the Rehabilitation Act of 1973 (Section 504).
    • “Under the revised timeline:
      • “Recipients with 15 or more employees will now have until May 11, 2027, to comply.
      • “Recipients with fewer than 15 employees will now have until May 10, 2028, to comply.

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “After a surprise rejection at the beginning of 2026, the FDA has agreed to reconsider a T-cell therapy based on the same single-arm trial that the agency had previously found problematic.
    • “For Pierre Fabre Pharmaceuticals and Atara Biotherapeutics’ Ebvallo, the FDA agreed during a recent meeting that a single-arm study using an appropriate historical control “could serve as an adequate and well controlled study” in support of an application for approval, the two companies said Thursday.
    • “Pierre Fabre and Atara are aiming to get Ebvallo, also known as tabelecleucel or tab-cel, approved for patients with relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+PTLD) who have failed on an anti-CD20 regimen. Before the FDA, European regulators had already greenlighted the immunotherapy for the indication in 2022.”
  • MedPage Today adds,
  • and
    • “An investigational trivalent mRNA-based vaccine reduced confirmed flu illness by 26.6% through the end of the flu season compared with approved standard-dose vaccines in a randomized trial among adults ages 50 and older.
    • “The mRNA vaccine led to more adverse events, particularly injection-site pain and fatigue, but most were transient and mild without an excess of more serious risks.
    • “An FDA decision on approval is expected by August.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Using the blood of a 56-year-old woman vaccinated against measles, scientists have isolated a fighting force of four potent virus-blocking antibodies that could pave the way toward a treatment for people exposed to the highly contagious respiratory disease making a comeback in the United States.
    • “A safe, highly effective vaccine for measles has been available since the 1960s, and the U.S. officially eliminated the disease in 2000, with sporadic cases and outbreaks. But dropping vaccination rates have sparked large outbreaks in multiple states, and the country is edging closer to the virus spreading freely again—which puts more people at risk.
    • “New ways to block or treat measles would be particularly important for people who are immunocompromised and babies under the age of 1, because they are not eligible for the vaccine, leaving them unprotected amid a growing number of cases.
    • “Measles was a problem that was solved. Until it wasn’t solved anymore,” said Erica Ollmann Saphire, president of the La Jolla Institute for Immunology who led the study published Thursday in the journal Cell Host & Microbe. But she and other scientists stressed that this approach was not a substitute for a vaccine.
    • “The treatment is always going to be more expensive than the vaccine. It’s the best bang for your public-health buck — this is for people that couldn’t be vaccinated,” Saphire said.”
  • MedPage Today adds, “A new systematic review in The BMJ reported that current evidence did not support causal associations between aluminium adjuvanted vaccines and serious or long-term health outcomes.“
  • Infectious Disease Advisor notes,
    • “HIV pre-exposure prophylaxis (PrEP) uptake remains suboptimal among commercially-insured adolescents and young adults in the United States, highlighting the need for targeted interventions to address access barriers.”
  • The American Medical Association lets us know what doctors wish their patients knew about swimmer’s ear.
    • “Diving into pools or spending the day at the beach or lake can be the epitome of summer fun, but these aquatic adventures can also come with an unwelcome companion: otitis externa, commonly known as swimmer’s ear. This common affliction can sideline even the most dedicated water enthusiasts with its painful consequences. With the incidence of swimmer’s ear rising during the warmer months, understanding its causes, symptoms and prevention methods is essential for water enthusiasts of all ages.” 
  • The National Institute for Health Care Management’s May newletter discusses “Cancer Trends & Treatment Advancements”
  • Per BioPharma Dive,
    • “CellCentric, a biotechnology company developing an experimental drug for multiple myeloma, announced Wednesday it raised a $220 million Series D round to finance mid- and late-stage trials.
    • “Its lead drug, dubbed inobrodib, is an oral medicine that blocks a pair of proteins called “p300” and “CBP,” which in turn prevents the expression of certain key cancer-driving genes. CellCentric believes the treatment might be useful as an additive therapy across different lines of care in multiple myeloma. 
    • “The biotech is testing inobrodib in an all-oral combination involving Bristol Myers Squibb’s Pomalyst, as well as in conjunction with bispecific antibodies for myeloma such as Pfizer’s Elrexfio and Johnson & Johnson’s Tecvayli. It’s also evaluating use in a “maintenance” setting, where treatments are used to keep cancer from returning.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “Blue Shield of California debuted its virtual-first Virtual Blue healthcare plan just over three years ago. Now, the data is rolling in.
    • “The program began in 2023 through a collaboration with tech-enabled healthcare platforms Accolade — now owned by Transcarent — and TeleMed2U. The program has no out-of-pocket costs for visits with virtual-only providers, can often deliver same-day care and now has more than 150,000 members. Blue Shield is even tacking virtual primary care options onto its Trio HMO plan, expanding offerings into the individual market.
    • “Tim Lieb, Blue Shield of California’s senior vice president of commercial markets, recently joined the “Becker’s Payer Issues Podcast” to discuss Virtual Blue’s early strengths and challenges.”
  • Healthcare Dive relates,
    • “Nearly 8 in 10 employers report GLP-1 drugs are driving heightened healthcare costs at their companies, pushing some to consider dropping coverage of the pricey weight loss medications, according to a survey released Tuesday by the Business Group on Health.
    • “Only 72% of employers that cover GLP-1s for weight management said they’d likely maintain that coverage next year, while 10% reported they likely wouldn’t, according to the group, which represents employers that provide health coverage. 
    • “Additionally, 87% of respondents said new oral versions of GLP-1 drugs would result in higher demand for the medications, but only 9% predicted prices would decrease.”
  • and
    •  Providing hospital-level care in patients’ homes was linked to better clinical outcomes, suggesting hospital-at-home programs could serve as a safe and efficient alternative to traditional inpatient care, according to a study published this week in JAMA Network Open. 
    • Hospital at home was associated with decreased emergency department use within 30 days of discharge and lower in-hospital mortality, according to the research. But patients at hospital-at-home programs saw no significant difference in hospital readmissions within 30 days. 
    • Additionally, adoption of hospital at home across the country is uneven, with few rural facilities participating, researchers wrote. The findings “underscore the need to address practical and implementation challenges to broaden equitable access,” they said.
  • Per Healthcare Cost Institute news releases,
    • Health care spending can differ dramatically depending on where Americans live, with costs varying by more than twofold from one metro area to another, according to new findings from the Health Care Cost Institute (HCCI). Charleston, WV, tops the list of the highest spending markets, with annual costs more than twice those in places like Bakersfield, CA, one of the country’s lowest spending areas.
    • The new data comes from the Health Cost Landscape, HCCI’s updated interactive platform that compares health care spending, prices, service use, and market dynamics across 269 metro areas in 45 states. The tool gives a clear, local look at how health care markets function and where consumers are paying the most for care.
  • and
    • “The Transparency in Coverage (TiC) regulations have introduced unprecedented visibility into negotiated health care prices in the United States. By requiring insurers to publish machine-readable files containing payer–provider contracted rates starting in 2022, the policy has created a new data source for studying price variation. However, the scale, inconsistency, and missing information within the TiC data mean that rigorous methodological work is required before it can be used for research. This brief explores the nature of this data, how it is accessed and processed, and how it can be used for analysis, with a detailed walkthrough of a real example examining childbirth prices in Pennsylvania.” * * *
    • “Transparency in Coverage data represent a significant advancement in the availability of information on negotiated health care prices, offering researchers a new lens into variation across payers, providers, and markets. As demonstrated in the childbirth analysis in Pennsylvania, TiC data can be used to replicate and extend findings from traditional claims-based research, particularly in understanding the range and distribution of negotiated rates across payers and providers.
    • “At the same time, the value of TiC data depends heavily on the methods used to create an analytic dataset. The raw data are not inherently research-ready and require substantial processing, including careful service definition, data cleaning, provider and payer entity resolution, and restrictions to ensure comparability. Without these steps, analyses may not be replicable and risk reflecting the messiness of the raw data rather than meaningful differences in prices. Additionally, the absence of utilization data remains a fundamental limitation, requiring integration with external sources to fully assess spending and average prices.
    • “Overall, TiC data should be viewed as a powerful but incomplete resource. When used appropriately, they can provide important insights into health care pricing dynamics and market structure. As data quality improves and methods continue to evolve, TiC data are likely to become an increasingly valuable complement to claims data in health services research.”
  • Per Fierce Healthcare,
    • “Hims & Hers launched an artificial intelligence agent embedded in its platform to help interpret biomarker lab results and provide users personalized insights about their health.
    • “The company launched its direct-to-consumer lab testing program for health biomarker testing back in November. The new agent AI, Labs AI, has been available to some customers in beta testing and will roll out to all Labs customers over time, the company announced Thursday.
    • “Hims & Hers’ Labs offers access to 130 biomarker tests across 10 health areas, including heart health, metabolism, hormones, inflammation and stress, as part of its strategy to extend into prevention and health screening. The new AI care agent makes customers’ lab results clearer, more useful and easier to engage with, according to Patrick Carroll, M.D., Hims & Hers chief medical officer.”
  • and
    • “Ardent Health topped the market’s revenue and earnings estimates, touting Wednesday solid adjusted admission and labor spend numbers despite what has proved to be a tumultuous first quarter for hospitals. 
    • “The publicly traded for-profit logged $1.6 billion of total revenue, which was up 7% year over year and 1.3% above Zacks Investment Research’s consensus estimate. Net income was $40 million, or 28 cents per share, beating the consensus estimate of 18 cents per share. 
    • “Similar to other for-profit health systems’ reports from the past few weeks, executives acknowledged the impacts of a weak respiratory season and severe winter storms on Ardent’s business, particularly in Texas, Oklahoma and New Jersey. That led to a 1.1% year-over-year decline in admissions, though CEO Marty Bonick said during Wednesday’s earnings call that the company “acted swiftly to reschedule surgeries and adjust labor to align with volume, mitigating the impact on our performance.”
  • Per Fierce Pharma,
    • “With an eye on the lucrative U.S. market, Italy’s Angelini Pharma will acquire rare disease specialist Catalyst Pharmaceuticals and its potential blockbuster, Firdapse, for $4.1 billion.
    • “Rome-based Angelini, a family-owned private company established in 1919, is paying $31.50 per share for Florida-based Catalyst. It is a 3% premium on Catalyst’s share price at close yesterday and a 21% premium on its price on April 22 before market activity hinted at public knowledge that a sale was in the offing. Bloomberg reported the potential buyout on April 27, triggering another stock surge.”
  • Per MedTech Dive,
    • “Roche has agreed to acquire PathAI, a Boston-based digital pathology firm, for up to $1.05 billion.
    • “Roche plans to pay $750 million upfront and up to $300 million in additional milestone payments, according to a Thursday announcement. 
    • “The acquisition is expected to close in the second half of 2026, subject to customary closing conditions, including antitrust and regulatory approvals.”

Monday report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Medicare, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Per a Senate news release,
    • “The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee will hold two field hearings in Louisiana this week to discuss how Congress can make health care affordable and improve mental health and substance use disorder treatment. The Committee will hear from a variety of perspectives within the health care system, including patients, providers, and local subject matter experts.” * * *
    • “Title: Making Health Care Affordable Again Part 2: Perspectives from Employers, Patients, and Providers
    • “Date: Tuesday, May 5, 2026
    • “Time: 9:00 AM CT/10:00 AM ET
    • “Location: LSU Foundation Building, 3796 Nicholson Drive, Baton Rouge, LA
    • “Click here to watch this hearing live.”
  • The Wall Street Journal reports,
    • “Health Secretary Robert F. Kennedy Jr. is announcing steps that he said are aimed at helping wean some Americans off psychiatric medications, including antidepressants.
    • “Too many patients begin treatment without a clear understanding of the risks, and how long they will stay on these drugs, or how to come off them,” he said to an audience at an event hosted by the Make America Healthy Again Institute, a nonprofit, on Monday. “We are going to fix it.” 
  • Here is a link to the HHS news release about this announcement.
  • Per U.S. Office of Personnel Management news releases,
    • “The US Office of Personnel Management (OPM) today recognized Public Service Recognition Week, honoring the federal employees who serve the American people every day and highlighting the critical role public servants play in delivering results for taxpayers.
    • “Observed annually during the first full week of May, Public Service Recognition Week celebrates the dedication, professionalism, and impact of public servants across the federal government and at all levels of public service. This recognition also comes as OPM continues its work to strengthen the federal workforce through modern hiring, performance management, and workforce development initiatives.”
  • and
    • “The US Office of Personnel Management (OPM) today announced the expansion of access to USA Class, an artificial intelligence (AI)–enabled tool designed to accelerate the creation of federal position descriptions, to all federal agencies using USA Staffing at no additional cost.
    • “This move integrates USA Class directly into the federal government’s primary hiring platform, providing hiring managers and human resources professionals with modern tools to reduce administrative burdens and speed the hiring process.
    • “USA Class uses AI technology trained on thousands of existing federal position descriptions to help managers quickly generate structured draft duties and assist classifiers in aligning those duties with OPM classification standards. The tool is designed to strengthen collaboration between managers and classifiers, reduce rework, and significantly shorten timelines needed to prepare position descriptions, an essential first step in the hiring process.”
  • OPM Director Scott Kupot discusses the USA Class initiative in the latest post in his Secrets of OPM blog.
    • “Don’t get me wrong – hiring is still hard, and I don’t suspect AI will fully solve that problem in the near term. But we are using AI to streamline the tasks for which computers are very capable and free up time for HR professionals and hiring managers to focus on the people-facing aspects of recruiting and assessing candidates. More to come.”
  • Fierce Healthcare offers “A deeper dive into the ACCESS Model—Who’s participating, potential headwinds and how it could spur health plan adoption.”
    • “The CMS ACCESS Model creates a new category of Medicare Part B providers, ACCESS organizations, that can receive outcome-aligned payments for managing qualifying chronic conditions. The model shifts away from remote patient monitoring (RPM) and chronic care management (CCM) billing codes that offer payments for specific activities.
    • “This access model introduces an alternative approach, which is, you get rid of the billing codes altogether, and you have these new outcomes-aligned payments,” said Aneesh Chopra, chair of the Arcadia Institute.
    • “Chopra, who served as the first U.S. Chief Technology Officer, asserts that the ACCESS model redefines value-based care as it eliminates complexity and makes value-based care scalable.
    • “The use of AI technologies enables companies and providers to take a scarce resource—care management—and make it abundant, Chopra noted, to scale it to more patients living with chronic conditions.”
  • Healthcare Dive relates,
    • “The Department of Justice’s fraud division last week launched a strike force dedicated to rooting out healthcare fraud on the West Coast, as the Trump administration continues to double down on fraud enforcement across the country. 
    • “The West Coast Health Care Fraud Strike Force brings the DOJ’s healthcare fraud unit together with the U.S. attorney’s offices for Arizona, Nevada and the Northern District of California, to coordinate on cases in the region, according to a Thursday press release. 
    • “The strike force will bring increased enforcement resources to Northern California — one of the nation’s hubs for health technology development — and Arizona and Nevada, where the DOJ says healthcare fraud schemes are rising.” 

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Incyte is poised to expand the reach of its blockbuster JAK inhibitor Jakafi with a new once-daily, extended-release version that’s soon to hit pharmacy shelves. 
    • “The FDA signed off on Jakafi XR under the same indications as original Jakafi, allowing its use to treat intermediate or high-risk myelofibrosis, polycthemia vera and graft-versus-host disease. In a bioequivalence study, a single 55-mg Jakafi XR tablet exhibited consistent, day-long exposure comparable to a twice-daily 25-mg immediate-release Jakafi dose. 
    • The new version allows for expanded treatment options “without changing the well-established role of Jakafi in clinical practice,” Incyte’s CEO Bill Meury explained in a company release.”
  • and
    • “Along with partner Lannett, a subsidiary of China’s Sunshine Lake Pharma has brought a biosimilar of Sanofi’s insulin glargine Lantus to the U.S., adding a cheaper interchangeable option to the diabetes treatment landscape. 
    • “The green light makes Lannet and Sunshine’s product the first long-acting insulin from a Chinese company to win the FDA’s blessing. 
    • “The biosimilar will be sold under the brand name Langlara and is now FDA-approved to treat adult and pediatric patients with type 1 diabetes as well as adults with type 2 diabetes. Langlara also received an interchangeable designation from the FDA, meaning that it can be distributed by pharmacists in place of Lantus without sign-off from a physician.”   

From the judicial front,

  • Per a Department of Justice news release,
    • “Two men were sentenced today for their roles in a scheme to defraud Medicare, Medicaid, and private health insurance companies by submitting over $522 million in fraudulent claims for medically unnecessary genetic tests that were obtained through the payment of illegal kickbacks and bribes.
    • “Reyad Salahaldeen, 57, of Buford, Georgia, was sentenced to 151 months in prison after pleading guilty to conspiracy to commit health care fraud and wire fraud. Mohamad Mustafa, 28, of Duluth, Georgia, was sentenced to three years in prison after pleading guilty to paying health care kickbacks.
    • “Under the guise of health care, these two fraudsters attempted to steal more than half a billion dollars from taxpayers through a web of sham contracts, lies, and bribes,” said Colin M. McDonald, Assistant Attorney for the National Fraud Enforcement Division. “These schemes deplete America’s pocketbook and destroy the trust in medicine that patients deserve and demand. The Department of Justice will remain vigilant in our efforts to deter those defrauding the American people in the name of health care. I thank the prosecutors and our law enforcement partners at FBI and HHS-OIG who worked tirelessly for this just outcome.”

From the public health and medical / Rx research front,

  • A neurologist, writing in the Washington Post, tells us about “six ways to keep work stress from fueling headaches.”
  • The American Medical Association lets us know what doctors wish their patients knew about Lyme Disease.
    • “An early sign of Lyme disease is a bullseye rash from a tick bite. But symptoms can worsen if left untreated. Three infectious diseases physicians share more.”
  • Cardiovascular Business reports,
    • “Long-term antidepressant use may increase a person’s risk of sudden cardiac death (SCD), according to new findings published in Heart Rhythm.
    • “SCD frequently occurs without warning, often in individuals without previously diagnosed cardiovascular disease,” wrote first author Jasmin Mujkanovic, MD, a cardiologist with Copenhagen University Hospital, and colleagues. “It accounts for a significant proportion of cardiovascular mortality worldwide. Psychiatric disorders have previously been shown to be associated with SCD, with major depressive disorders having a twofold increased risk … Pharmacologic treatment of depression, with antidepressants among the most common pharmaceuticals prescribed, adds another layer of complexity.”
  • MedPage Today relates,
    • “Kids seen by primary care clinicians for acute respiratory tract infections were prescribed antibiotics less often during telemedicine visits versus in-person visits in a cross-sectional study.
    • “The difference was driven by more telemedicine diagnoses of viral infections and sinusitis versus more in-person diagnoses of acute otitis media and streptococcal pharyngitis.
    • “There were no significant differences between groups in antibiotic management guideline concordance, follow-up visits, or antibiotic prescription within 14 days after the initial visit.”
  • and
    • “A 10% increase in ultraprocessed food intake was tied to lower attention scores and greater dementia risk in a cross-sectional study.
    • “The relationships persisted even in people who followed a Mediterranean diet.
    • “No relationship emerged between ultraprocessed food intake and memory scores.”
  • Health Day informs us,
    • “Antibiotics don’t appear to increase a person’s risk of developing celiac disease, a new study says.
    • “Patients with celiac disease had a 24% higher odds of antibiotic use compared to healthy siblings or members of the general public, researchers reported recently in the journal Clinical Gastroenterology and Hepatology. 
    • “However, the odds of antibiotic use were even higher — 50% — among a group of people whose gut lining was normal, when they were compared to the general public, researchers said.
    • “These results indicate that earlier studies that linked celiac disease to antibiotics reflect a heightened awareness of the disorder, in which the gut becomes inflamed if a person eats gluten.
    • “We do not see a causal link between celiac disease and antibiotics,” said lead researcher Dr. Maria Ulnes, a pediatrician and doctoral student at the University of Gothenburg in Sweden.”
  • Radiology Business points out,
    • “A new 4D mammography technique could diagnose cancer with up to four times the precision of 3D digital breast tomosynthesis (DBT) exams. 
    • “That’s according to early data out of an ongoing first-in-human clinical trial at Baptist Health Hardin in Elizabethtown, Kentucky. The trial is testing the utility of the 4D mammography system developed by Calidar Inc.—a medical technology startup out of North Carolina. Calidar’s 4D system harnesses X-ray diffraction imaging to measure molecular-level signatures of disease; these tissue “fingerprints” could help providers diagnose breast cancer in its earliest stages, but current mammography systems do not have this capability. 
    • “Calidar has indicated that its 4D system also allows for exams to be completed more quickly, and at a reduced radiation dose compared to 2D and 3D scans.” 

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

  • Beckers Payer Issues explains,
    • “Healthcare more broadly has been focused on reaching consumers where they are at. Health systems have established virtual care partnerships, and prescription drugs are now more accessible via direct-to-consumer pathways.
    • “But health insurers have also been developing strategies to reach members more directly, such as through transparent pricing and shifts in product offerings.”
    • The article offers several examples.
  • The Wall Street Journal reports,
    • UCB said it agreed to buy Candid Therapeutics [which is based in San Diego, CA] for up to $2.2 billion, in a deal that seeks to bolster the Belgian pharmaceutical company’s pipeline of experimental treatments for autoimmune and inflammatory diseases.
    • Brussels-based UCB said Sunday that it would pay $2 billion upfront and up to $200 million subject to future targets to acquire Candid. Its latest acquisition follows a licensing agreement with China’s Antengene valued at up to $1.18 billion in March, and a deal to buy epilepsy-therapy developer Neurona Therapeutics for up to $1.15 billion last month.
    • Privately held Candid is developing a portfolio of experimental drugs to treat autoimmune and inflammatory diseases and its lead candidate, cizutamig, is a so-called bispecific antibody being tested in multiple early-stage clinical trials across a number of indications, UCB said.
  • Fierce Healthcare relates,
    • “UPMC and CommonSpirit’s talks to hand over a three-hospital system in eastern Ohio have progressed to a definitive agreement between the parties with a transaction expected to close in the fall. 
    • “Financial terms of the deal for CommonSpirit’s Trinity Health System were not disclosed, and a close would require regulatory clearances.
    • “Trinity Health System and UPMC share a commitment to providing top-tier care and serving the most vulnerable members of our community,” Dwayne Richardson, interim president of Trinity Health System, said in a Monday release announcing the agreement. “UPMC’s proven track record of community service and compassionate approach to care were key factors in our decision, and will significantly benefit our patients.”
    • “Trinity Health System includes facilities for urgent care, behavioral health and physician offices alongside its hospitals. The deal reflects a market expansion for UPMC, which is based in Pittsburgh, Pennsylvania and dominates the western half of that state with more than 40 hospitals and 800 outpatient sites.” 
  • Radiology Business notes,
    • “It may be more than anxiety and forgetfulness to blame for women missing their scheduled mammograms, according to new survey data. 
    • “Missed breast imaging appointments are not uncommon. In fact, prior research has suggested that breast imaging appointments account for the largest number of no-shows in imaging. This can be problematic for both practices and patients, experts explain in a new paper in Academic Radiology.” * * *
    •  
  • Healthcare Dive tells us,
    • “Healthcare bankruptcies rose in the first quarter after declining last year, according to a report released last week by restructuring advisory firm Gibbins Advisors.
    • “Twelve healthcare companies with liabilities of at least $10 million filed for Chapter 11 bankruptcy protection in the first quarter, up 33% from the fourth quarter of 2025. 
    • “Senior care firms and physician practices drove bankruptcies in the first quarter, with four filings each.” * * *
    • “The most common reason for missing an exam was forgetting about the appointment, cited by 35% of respondents. Financial and logistical issues, however, also represented a significant barrier for many; 19% indicated that financial hardship prevented them from attending their appointment, while another 20% said they did not have transportation to get to their exam. Notably, respondents who fell under lower income brackets most often cited issues with payments and transportation. Notably, around 30% of the patients who missed their appointment never rescheduled. 
    • “In terms of improving follow through, respondents suggested that more frequent reminders would be beneficial; the majority signaled that text message reminders were the most effective. Other suggestions included some form of payment assistance and transportation services.”  
  • Joanna Stern writing in the Wall Street Journal describes a personal experience with AI enhanced mammography.
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) posted a Protocol today outlining how it will conduct its second annual analysis titled the “Launch Price and Access Report,” which will examine launch prices and patient access for new FDA-approved treatments. This protocol was developed with input from a multi-stakeholder working group* consisting of patient and consumer advocates, clinicians, policy experts, payers, and life science companies. 
    • “In the upcoming report, to be released in October 2026, ICER will analyze launch price trends over four years (2022-2025). ICER is also conducting an in-depth review of newly launched drugs (July 2024 to June 2025 novel drug approvals) by:
      • “Evaluating the impact of pricing above ICER’s Health Benefit Price Benchmark (HBPB)† for drugs that ICER has previously reviewed.
      • “Evaluating patient access to newly launched drugs using real-world pharmacy and medical claims data, payer coverage policies, and direct patient surveys.
    • “The complete timeline for ICER’s Launch Price and Access report is available here.”
  • Fierce Pharma tells us,
    • “With three weeks of data on Lilly’s oral GLP-1 launch in obesity now on the books, the dimensions of Foundayo’s rollout—and its critical comparison to that of Novo Nordisk’s Wegovy pill—are coming into focus. 
    • “In its third week on the U.S. market, which ended April 24, Foundayo generated some 5,600 prescriptions, analysts at Jefferies wrote in a May 1 note to clients. That level of adoption is numerically lower than the stats recorded by the Wegovy pill in its third week, when prescriptions for the oral obesity med came in at around 26,100, per the note. 
    • “Nevertheless, almost all of Foundayo’s recorded performance stems from cash pay channels, according to the Jefferies team, with commercial access via insurance set to come online by the middle of this month, which will likely give Foundayo a substantial boost in uptake. 
    • “The team acknowledged that Foundayo’s reimbursement “appears to be ramping more slowly vs oral Wegovy’s.” 
    • “Overall, the analysts described Foundayo as “off to a solid start,” and estimate the drug will generate $146 million in the second quarter and $1.6 billion for all of 2026. That compares to consensus forecasts of $134 million and $1.2 billion, respectively.” 

Midweek update

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “The House took a major step toward providing funding for immigration enforcement agencies by adopting a Senate-backed budget resolution Wednesday evening.
    • “Now that both chambers have adopted the budget blueprint, lawmakers can move forward with a filibuster-proof reconciliation bill to provide around $70 billion in immigration enforcement funding. That money is designed to sustain the Immigration and Customs Enforcement and Customs and Border Protection agencies for the remainder of President Donald Trump’s term.
    • “The vote on the GOP-written resolution was 215-211, falling strictly along party lines. Rep. Kevin Kiley of California, a Republican-turned-independent from a swing district, voted “present.”
  • The Government Accountability Office released a report today finding
    • he Federal Employees Health Benefits program is the largest employer-sponsored health insurance program in the United States. The Office of Personnel Management is responsible for managing fraud risks in the program.
    • But OPM’s process for verifying whether health care providers were eligible to provide care under the program isn’t always working. For example, our data analyses identified claims from providers who were deceased or excluded from other federal programs for certain violations.
    • Our [fifteen] recommendations would improve OPM’s process for verifying health care provider eligibility and reduce risks to the program.
  • Fedweek relates,
    • In a memo issued on April 28, 2026, Office of Personnel Management (OPM) Director Scott Kupor advised federal agencies to exclude all employees in Schedule C and Schedule G General Schedule (GS) positions from the performance appraisal requirements under Subchapter I of Chapter 43 of Title 5, including requirements for performance standards, progress reviews, and annual ratings of record.
    • “This directive simplifies personnel management for these excepted-service political appointments, which are now treated as “at-will” roles where retention and removal do not hinge on formal performance ratings. 
    • “The memo clarifies that these employees operate outside the structured appraisal frameworks that apply to most competitive-service GS employees. They are excluded due to the confidential, policy-determining, policy-making, or policy-advocating nature of their positions.
    • “This latest memo is not a surprise, as it is a step in implementing [Schedule F] policies that have already been formulated.”
  • The Hill tells us,
    • “The Trump administration is no longer allowing federal funds to be used for purchasing or distributing test strips that can determine if street drugs have been mixed or cut with fentanyl or other contaminants, a reversal that comes amid the administration’s broader opposition to harm reduction practices. 
    • “In an open letter to federal grantees, the Substance Abuse and Mental Health Services Administration said it was ending the practice, which it has championed since 2021, because the strips are “intended for use by people using drugs.” 
    • “However, the notice emphasized that federal funds can still be used for test strips to be used by public health officials, law enforcement, medical workers and others in professional settings.  
    • “Test strips cost about $1 each and can detect drugs like fentanyl or animal tranquilizers like xylazine and medetomidine. Many states have legalized test strips in an effort to slow the number of overdose deaths.” 
  • The American Hospital Association News informs us,
    • “The Agency for Healthcare Research and Quality has issued a request for nominations for candidates to serve on the U.S. Preventive Services Task Force. While all nominees will be considered, AHRQ said it encourages nominations of physician specialists in anesthesiology/pain management, cardiology, endocrinology, family medicine, gastroenterology, hematology/oncology, internal medicine, obstetrics and gynecology, pediatrics, preventive medicine and radiology, as well as experts in health economics. The agency said it will also consider applications from physicians in specialties including but not limited to surgery, laboratory medicine/molecular pathology and clinical genetics. AHRQ is also seeking wide geographic representation and experience in diverse settings, including individuals with expertise in rural medicine. Nominations must be received by AHRQ electronically by May 23 to be considered for appointment beginning in June.”
  • Bloomberg Law adds,
    • “The Trump administration is appealing a federal district court order that temporarily blocked US Health Secretary Robert F. Kennedy Jr.’s changes to the nation’s childhood vaccine schedule.
    • “The US Department of Justice filed a notice Wednesday to appeal an order issued March 16 by Judge Brian Murphy of the US District Court for the District of Massachusetts that halted decisions made by a vaccine advisory panel earlier this year to drastically reduce the number of recommended shots for kids. 
    • “The appeal to the US Court of Appeals for the First Circuit challenges the judge’s decision to temporarily block Kennedy’s appointments of 13 members to the panel, the Advisory Committee on Immunization Practices, which helps determine which vaccines are covered by insurance and provided for free for some children.
    • “The committee was scheduled to convene on March 18-19 at the US Centers for Disease Control and Prevention headquarters, but the court ruled it can’t meet and the meeting was subsequently postponed.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration on Wednesday released the results of a major study examining the safety of infant formula sold in the U.S., finding that most products contained low or undetectable levels of contaminants including heavy metals.
    • “The findings come amid “Operation Stork Speed,” the Trump administration’s sweeping review of U.S. infant formula ingredients. Federal officials said the results reinforce that the nation’s infant formula supply is safe, while adding that the FDA will continue additional testing as part of its continuing monitoring and oversight efforts.
    • “We tested more infant formula than ever before, and the results are clear: most products meet a high safety standard—but even small exposures matter for newborns,” Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement.” * * *
    • “Although the results didn’t break down findings by specific companies, leading manufacturers welcomed the report.”
  • MedTech Dive relates,
    • “Medtronic received Food and Drug Administration approval for its next-generation mitral valve and has launched the device in the U.S., the company said Wednesday.
    • “Called Mosaic Neo, the bioprosthetic valve is designed to be implanted through sternotomy, which requires separating the breastbone to reach the heart, or through minimally invasive surgery.
    • “In addition, the first concomitant procedure was performed where the Mosaic valve was implanted alongside Medtronic’s Penditure left atrial appendage exclusion device, the company said. The Penditure clip is designed to close the left atrial appendage to help prevent clots from entering the bloodstream.”
  • Cardiovascular News informs us,
    • “The U.S. Food and Drug Administration (FDA) is warning the public about a potential safety issue with certain Relay Pro Thoracic Stent Grafts from Terumo Aortic. 
    • “These devices are used by interventional cardiologists and vascular surgeons to repair damaged or weakened sections of a patient’s thoracic aorta. However, Terumo Aortic has received multiple reports of the stent being unable to unclasp from the delivery system. When this happens, it can lead to significant risks, including death. As of April 23, in fact, three deaths have been directly linked to this issue.
    • “Difficulties in releasing the stent graft may result in delay of procedure, stent graft displacement, and an inability to release the stent graft,” according to the FDA’s warning. “This may require conversion to open surgical repair to release the clasp and can result in patient death. Please be advised that this failure mode can occur without prior warning and no device-based bailout method has been identified for this specific scenario.”
  • and
    • “Abbott has received U.S. Food and Drug Administration (FDA) clearance and CE mark approval for Ultreon 3.0, its next-generation coronary imaging platform.
    • “Ultreon 3.0, an update of the company’s Ultreon 2.0 technology, uses advanced artificial intelligence (AI) algorithms to capture and evaluate optical coherence tomography (OCT) images, delivering real-time guidance during percutaneous coronary intervention (PCI) procedures. OCT is a critical modality for the diagnosis, treatment and management of coronary disease. This platform was built to give clinicians detailed OCT images from inside the blood vessels. It then uses those images to assess the blockage being treated and make recommendations to the PCI operator on the selection and placement any stents.
    • “Ultreon 3.0 represents a pivotal step forward in how we treat and ultimately care for our patients,” Evan Shlofmitz, DO, director of interventional cardiology at St. Francis Hospital and Health Center in Roslyn, New York, said in a statement. “This next-generation platform, combining imaging and AI, doesn’t just improve upon existing technology—it leapfrogs it. By delivering greater clarity, speed, and clinical insight, Ultreon 3.0 accelerates the path to more confident clinician decision making and transformative patient care.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Marriage is linked to a lower risk of developing cancer, recent research found.
    • “A study of more than 4 million cancer cases in the U.S. found that cancer rates were about 68% higher among men who have never married compared with those who have. For never-married women, the relationship was even more pronounced, with cancer rates roughly 83% higher, according to research published recently in the journal Cancer Research Communications.
    • “Married people tend to have greater economic stability and better support systems, and they are more likely to stick with treatment, said Paulo Pinheiro, professor of cancer epidemiology at the University of Miami School of Medicine’s Sylvester Comprehensive Cancer Center and co-author of the findings. 
    • “Previous studies have found that married people who have cancer tend to get diagnosed earlier and have better survival rates. 
    • ‘The recent study looked at data collected between 2015 and 2022 encompassing more than 100 million people aged 30 or older from across 12 states. About 20% were unmarried.” 
  • Healio informs us,
    • “A large measles outbreak in South Carolina has ended after nearly 1,000 cases.
    • “More than 8,000 measles vaccinations were administered during the outbreak, which began in October.”
  • Health Day relates,
    • “Mail-in colon cancer kits can extend easy, affordable cancer screening to low-income folks, study shows
    • “People preferred returning test kits that look for cancer-related DNA
    • “That might be because the kits had more comprehensive support from their manufacturer, researchers said.”
  • Medpage Today tells us,
    • “Over 15 years, a moderately protein-restricted diet was tied to a lower risk of starting dialysis in patients with stages 3 or 4 chronic kidney disease.
    • “Associations with a 50% eGFR decline and all-cause mortality approached, but did not achieve, statistical significance.
    • “Findings support guideline-based care while emphasizing practicality, the researchers noted.”
  • Per an Institute for Clinical and Economic Review (ICER) news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of oveporexton (Takeda Pharmaceutical Co., Ltd.) for narcolepsy type 1.
    • “Current treatments for narcolepsy do not address the underlying cause of the condition, and many patients report incomplete relief from narcolepsy symptoms despite multiple medications,” said ICER’s Senior Vice President of Research, Foluso Agboola, MBBS, MPH.  “ICER’s analyses found that oveporexton, the first medication for narcolepsy type 1 that directly addresses the underlying cause of the condition, is effective in promoting wakefulness, improving quality of life, and appears to offer better health benefits than current options. Pricing choices that balance innovation rewards while addressing long-term value and patient access will be important topics at the public meeting.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC on May 14, 2026. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
    • “Register here to watch the live webcast of the virtual meeting.” * * *
    • “Oveporexton has not yet been approved by the FDA for narcolepsy type 1. The manufacturers have not yet announced a US price for the therapy if approved. ICER calculated a health benefit price benchmark (HBPB) between $50,400 and $59,400 per year.”

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

  • The Wall Street Journal reports,
    • “Humana reported lower first-quarter profit, with shares down 7.4% in premarket trading, due to lower 2026 Medicare Advantage Star Ratings.
    • “The company reiterated its full-year adjusted-earnings guidance but cut its nonadjusted earnings outlook to at least $8.36 a share.
    • “Humana incurred charges for a multiyear transformation program and faced higher medical costs, particularly from older people using services.”
  • Beckers Payer Issues relates
    • “Blue Cross NC recorded a net loss of $497.3 million in 2025, according to regulatory filings.
    • “The insurer posted a net income of $68.5 million in 2024 and $133 million in 2023.” * * *
    • ‘The company reported total assets of $7.2 billion as of year-end 2025, with capital and surplus of $3 billion. Medicaid was the company’s largest line of business by direct premiums written at $3.5 billion, followed by Medicare at $2.2 billion, the Federal Employees Health Benefits program at $1.8 billion, Medicare supplement at $397.4 million, and dental at $101.3 million.”
  • and
    • “BlueCross BlueShield of Tennessee recorded a net income of $168.4 million in 2025, a 62% decline from $446.8 million in 2024, according to regulatory filings.
    • “In its 2025 impact report, the insurer said 89 cents of every premium dollar collected last year was used to pay member claims, and medical and pharmacy claims payments have increased 25% over the past five years.
    • “The company reported total assets of $6.7 billion as of year-end 2025, with capital and surplus of $5.4 billion. Medicare was the company’s largest line of business by direct premiums written at $2.5 billion, followed by the Federal Employees Health Benefits program at $1.1 billion, dental at $172.6 million, Medicare supplement at $153.5 million, and vision at $37.4 million.”
  • Fierce Healthcare tells us,
    • “Teladoc Health reported a 2% decline in revenue in the first quarter, but the telehealth giant touted “meaningful progress” in scaling insurance coverage for its BetterHelp mental health business as a catalyst for future growth.
    • “The virtual care company reported Q1 revenue of $613.8 million compared to $629 million a year ago. Access fees revenue decreased 8% to $484.7 million.
    • “U.S. revenue dropped 6% to $491.5 million while revenue from international markets rose 17% to $122.3 million. The company’s integrated care segment revenue inched up 2% to $395.4 million and its BetterHelp segment saw revenue fall 9% to $218.4 million. Aside from access fee revenue, Teladoc Health reported “other revenue” jumped 25% to $129.2 million during the quarter.
    • “The company reported adjusted EBITDA of $58.2 million, essentially flat year-over-year, and the company narrowed its losses from a loss of $93 million in Q1 2025 to a net loss of $63.8 million, or $0.36 per share, in the most recent quarter.”
  • Beckers Hospital Review discusses “three barriers to GLP-1 adherence — and how systems are overcoming them.”
  • Health CIO informs us,
    • “Nearly 80% of provider-payer partnerships recognized in KLAS Research’s 2026 Points of Light report centered on value-based care workflows. That figure stood at 48% the year before. The shift signals that interoperability has graduated from differentiator to baseline expectation. Success in provider-payer collaboration will now hinge on whether shared data drives measurable financial and clinical outcomes.
    • “The report, released in April 2026 and produced through KLAS’s K2 Collaborative, profiles 24 award-winning partnerships. KLAS validated each through structured interviews conducted between September 2025 and February 2026. Of those 24 collaborations, 23 involved interoperability or clinical data exchange in some form. Federal mandates such as CMS-0057-F are accelerating adoption of FHIR-based APIs and HL7 Da Vinci implementation guides. As a result, payers and providers are moving toward standardized exchange that supports patient access, payer-to-payer transfers, and electronic prior authorization.”
  • BioPharma Dive points out,
    • “Teva Pharmaceutical is wagering up to $900 million on a biotechnology company built around a potential treatment for Tourette syndrome.
    • “Through an acquisition announced Wednesday, Teva will take control of privately held Emalex Biosciences and its drug ecopipam, which is in late-stage clinical testing. Ecopipam is meant to inhibit “D1,” a kind of dopamine-regulating protein that research suggests may play a role in the involuntary movements, or tics, associated with Tourette’s. The antipsychotics often used to treat this disorder target a different but related protein, D2.
    • “The companies expect their deal to close sometime between July and the end of September. Terms hold that Teva will pay $700 million up front and possibly as much as $200 million more if ecopipam hits certain commercial goals. Emalex shareholders will be eligible to receive sales-based royalties as well.”

Weekend update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC

  • The House Ways and Means Committee will hold a hearing with health system CEOs on April 28, 2026, at 10 am ET.
  • Roll Call offers more details on this week’s activities on Capitol Hill.
  • Federal News Network interviews NARFE Staff Vice President John Hatton about OPM’s ill-advised health claims data warehouse and the Postal Service’s decision to suspend making contributions toward their employee’s retirement benefits due to its cash woes.

From the public health and medical / Rx research front,

  • Health Exec reports,
    • “The more you maintain good physical fitness from your mid-40s to your mid-60s, the likelier you are to add years to your life and life to your later years. 
    • “So conclude researchers at Texas Tech University Health Sciences Center who tracked cardiorespiratory health in around 25,000 adults from midlife through elder stages. 
    • “The team, led by Clare Meernik, PhD, MPH, assessed participants’ fitness using a treadmill test until age 65. From that point on, the researchers used Medicare data to watch for and record the onset of 11 major chronic conditions such as heart disease, diabetes, kidney disease and cancer.
    • “The Journal of the American College of Cardiology published the results April 21.”
  • The FEHBlog noted on Friday that tick bites are increasing in the U.S. The Washington Post offers relevant advice. “Experts explained what to do if you find a tick attached to your skin, including how to remove it and document it, and when to seek medical advice.”
  • Building on another FEHBlog post from Friday, the Wall Street Journal explains what heart valve patients need to know before treatment.
  • Cardiovascular Business adds,
    • “New-onset postoperative atrial fibrillation (POAF) remains the most common complication following cardiac surgery, typically developing within four days of treatment. While it often resolves on its own, POAF is also associated with longer hospitalizations, higher healthcare costs and an increased risk of poor clinical outcomes, including long-term mortality.
    • “How can care teams work to minimize a patient’s risk of developing POAF? What is the best way to manage POAF once it develops? To answer those very questions, the Society of Thoracic Surgeons (STS) gathered a committee of cardiac surgeons, cardiologists, anesthesiologists and intensivists who specialize in POAF. The group reviewed years of data, including randomized trials and contemporary treatment guidelines, and landed on a total of 15 recommendations for reducing the risk of POAF after cardiac surgery. This included eight preventive strategies, three intraoperative techniques and four postoperative treatments.
    • “The committee’s report, first presented at the STS annual meeting in New Orleans, is now published in full in The Annals of Thoracic Surgery.

From the U.S. healthcare business front

  • Health Exec kindly offers five reasons not to (solely) blame insurance companies for what ails US healthcare.
    • High health insurance premiums are largely driven by high underlying healthcare costs. 
    • Health insurers don’t raise premiums to be mean, greedy or otherwise uncaring. 
    • As a share of premium revenues, health insurers’ profit margins are generally modest.
    • Prior authorization: A necessary ‘evil’ without which things would be worse. 
    • There’s enough blame to go around. 
  • Health Exec reports,
    • “TV viewers of a certain age have a hard time avoiding commercials hawking pharmaceutical and medical products. That category is the second-most heavily advertised on TV. Only entertainment is ahead of it. 
    • “And that’s just TV. Across all media, pharmaceutical companies are spending close to $10 billion per year on direct-to-consumer advertising in the U.S., MediaRadar reports. Only the entertainment industry spends more. 
    • “This kind of drug-pushing is legal, of course. But is it good for the health status of Americans?
    • “There are two schools of thought on that question. One defends a soft yes, the other a hard no. Both get a hearing in a slice of investigative journalism from KFF Health News in partnership with The New York Times.”
  • MedCity News notes
    • “Regeneron Pharmaceuticals’ Otarmeni is now approved for treating hearing loss from an ultra-rare genetic mutation found in an estimated 50 newborns per year. While Regeneron will offer this gene therapy for free, the approval came with a rare pediatric disease priority review voucher that the company can sell for hundreds of millions of dollars.”

Thursday report

David Ermer–ACA, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Patient safety, U.S. Healthcare–

From Washington, DC

  • The American Hospital Association News reports,
    • “The Senate April 23 adopted a budget resolution by a 50-48 vote, paving the way for a narrow reconciliation bill focused on immigration enforcement funding. Congressional Republicans are seeking to use the reconciliation process primarily to end the partial shutdown of the Department of Homeland Security. The resolution instructs the Senate Homeland Security and Governmental Affairs Committee, the Senate Judiciary Committee, and the House Homeland Security and Judiciary committees to write legislation by May 15 that provides up to $70 billion in funding.  
    • “The vote followed a lengthy “vote-a-rama” session overnight that consisted of multiple proposed amendments from Democrats that failed to pass. Both chambers must pass a common budget resolution to move forward with the reconciliation process. Legislative action is expected in the House as early as next week.”  
  • STAT News reports,
    • “President Donald Trump’s acting attorney general on Thursday signed an order reclassifying state-licensed medical marijuana as a less-dangerous drug, a major policy shift long sought by advocates who said cannabis should never have been treated like heroin by the federal government.
    • “The order signed by Todd Blanche does not legalize marijuana for medical or recreational use under federal law. But it does change the way it’s regulated, shifting licensed medical marijuana from Schedule I — reserved for drugs without medical use and with high potential for abuse — to the less strictly regulated Schedule III. It also gives licensed medical marijuana operators a major tax break and eases some barriers to researching cannabis.
    • “The Trump administration also said it was jump-starting the process for reclassifying marijuana more broadly, setting a hearing to begin in late June.”
  • The Wall Street Journal tells us “What to Know About the Health Risks of Marijuana.”
    • “Studies show the drug can exacerbate anxiety and teen use poses risks for developing brains.”
  • STAT News adds,
    • “President Trump heralded a drug pricing agreement with Regeneron on Thursday, closing the last of 17 deals initially sought by the White House last year.
    • “Regeneron, as part of the private deal, will reduce prices on drugs to Medicaid, provide cholesterol medicine Praluent on TrumpRx for $225, and invest $27 billion in drug development in the United States.”
  • Tammy Flanagan, writing in Govexec, lets us know,
    • “I was planning to write about the number of TSP millionaires for this week’s column — until I started getting messages from former federal employees, all who retired on September 30, 2025, and are still waiting for their retirement benefit from the Office of Personnel Management (OPM) to be finalized.
    • “It is not completely surprising that retirement processing has slowed down, and for some former employees, they continue to wait for their retirement benefits to be finalized. But for the employees who have reached out for assistance, many have not received any money since their last paycheck was received in October 2025.
    • “It has been almost six months with very little or, in some cases, no money and little communication to help them understand how long they will have to continue to wait.” * * *
    • “In my experience, retirement processing is less like flipping a switch and more like closing out a file with dozens of tabs. One missing document or unresolved question can stop forward progress.
    • “Common culprits include late or incomplete payroll certifications, missing service history, unposted deposits or redeposits for prior service, unresolved military service credit, periods of leave without pay that need to be documented, name discrepancies, incomplete beneficiary or survivor elections, or court orders that require special handling.
    • “None of these problems are rare, and when thousands of cases arrive at once, the odds go up that more people land in the exception pile.”
    • Tammy then make suggestion on steps to take.

From the Food and Drug Administration front,

  • Healthcare Dive reports,
    • “The CMS and the Food and Drug Administration have unveiled a new pathway to speed up Medicare coverage for certain breakthrough medical devices.
    • “The pathway, called the Regulatory Alignment for Predictable and Immediate Device, or RAPID, allows the two health agencies to work together, and with companies, during the device review process to speed up Medicare coverage for certain FDA-designated Class II and Class III breakthrough medical devices.
    • “The approach could enable Medicare national coverage and payment as soon as two months after a device has received market authorization, compared with approximately one year or more under the current system, according to the Thursday announcement.”
  • The Wall Street Journal relates,
    • “Children born deaf because of a rare condition can now take a drug to restore their hearing after a gene therapy was approved in the U.S., ushering in a new era for the treatment of an inherited form of hearing loss. 
    • “The Food and Drug Administration approved Regeneron Pharmaceuticals’drug Otarmeni for children born with a faulty gene that plays a role in hearing. It targets a rare condition affecting an estimated 20 to 50 newborns in the U.S. each year and could eventually be expanded to an even wider population if additional studies succeed.
    • “In my wildest dreams I never thought we’d be here in my lifetime,” said Lawrence Lustig, a hearing specialist at Columbia University Irving Medical Center who helped lead the trial.
    • “Regeneron said it would offer the drug free to people in the U.S.”
  • MedTech Dive tells us,
    • “Tandem Diabetes Care issued an urgent medical device correction for a software problem with its Mobi insulin pumps.
    • “The malfunction may cause insulin delivery to stop, causing high blood sugar if not addressed, the Food and Drug Administration said in a Wednesday recall notice. 
    • “Tandem sent a letter to customers in October notifying them of the fault and instructing them to update their pump software as soon as possible. Tandem had reported four serious injuries related to the problem as of Nov. 4.”

From the judicial front,

  • Modern Healthcare reports,
    • “The Federal Trade Commission has reached an agreement in principle with U.S. Anesthesia Partners to settle the government’s 2023 lawsuit. 
    • “The terms of the preliminary settlement are confidential so USAP can carry out the negotiations necessary to fulfill them, the FTC said in a Thursday news release.
    • “The agency in its original complaint claimed the anesthesiology group allegedly violated antitrust laws and reduced competition for anesthesia services in Texas. The preliminary settlement resolves the charges, the FTC said Thursday.” 
  • The New York Times points out “A $440,000 Breast Reduction: How Doctors Cashed In on a Consumer Protection Law.”
    • A law meant to end surprise medical billing accidentally created a multibillion-dollar industry that is making doctors richer.”
  • FEHBlog observation – This is happening. Why can’t Congress and the regulators fix the problem?

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Novo Nordisk will seek regulatory approval for its semaglutide pill to treat Type 2 diabetes in children and adolescents after a late-stage trial showed it significantly reduced blood sugar in 10- to 17-year-olds.
    • “The once-daily semaglutide pill is currently marketed as Rybelsus in the EU and U.S. to treat diabetes in adults and will be available in the U.S. as Ozempic pill later in the second quarter. It is not currently approved for use in children or adolescents.
    • “The Danish drugmaker said Thursday that oral semaglutide has the potential to be the first oral GLP-1 to demonstrate a superior reduction in blood sugar levels compared with a placebo in children and adolescents with Type 2 diabetes, while maintaining the well-tolerated safety profile seen across other semaglutide trials.
    • “Over the past two decades, the prevalence of Type 2 diabetes among children and adolescents has increased substantially, yet treatment options for this population remain limited, underscoring a significant unmet need,” said Martin Holst Lange, Novo Nordisk’s chief scientific officer and head of research & development.”
  • MedPage Today relates,
    • “An investigational benzamide antipsychotic significantly improved symptoms in hospitalized adults with acute schizophrenia in a phase II trial.
    • “The drug, N-methyl amisulpride, is similar to its predecessor, amisulpride, but has some key differences in dosing and side effects.
    • “Because of the 4-week trial duration, long-term treatment durability wasn’t evaluated.”
  • Genetic Engineering and Biotechnology News tells us,
    • “Diabetes affects over half a billion people globally. Along with direct consequences to those with the disease, it also contributes to and predisposes affected individuals to a host of other conditions. Specifically, it is a known contributing factor in the development of vascular disease, including peripheral artery disease. While therapies exist, they are not very effective, and peripheral artery disease can lead to restricted blood flow in peripheral limbs, which sometimes leads to amputation. Understanding the mechanism driving the connection at the tissue and cellular level has the potential to improve therapy options and the development of new treatments.
    • “Normal function of the peripheral vasculature requires communication and cooperation between the vascular endothelium and macrophages. “Monocytes patrol the vascular endothelium and remove damaged cells, and intimal-resident macrophages maintain a nonthrombogenic endothelial state,” wrote the authors of a study led by Zhen Chen, PhD, at City of Hope. They explained that under stress, macrophages can modulate vascular remodeling and in certain conditions, like cancer, they “can secrete inflammatory mediators to disrupt endothelial cell tight junctions and increase endothelial cell permeability.”
    • “The team decided to explore the cellular cross-talk between macrophages and endothelial cells, as well as the resulting vascular function, to better understand the mechanisms behind peripheral artery disease induced by diabetes.
    • “They published their work in a paper titled “Diabetes-induced TREM2–endothelial cell signaling impairs ischemic vascular repair” in Science Translational Medicine.“
  • Healio tells us,
    • “Influenza vaccination continues to protect children from influenza-related outpatient visits and hospitalizations, according to post-pandemic data published in Pediatrics.
    • “We have had really severe recent seasons for flu, particularly in children,” Samantha M. Olson, MPH, an epidemiologist in the CDC’s influenza division, told Healio in an interview. “This study really adds to the growing body of evidence showing how protective flu vaccines can be for infants, children and adolescents, and this includes even the most severe outcomes.”
  • and
    • “People taking GLP-1s had reduced risk for atrial fibrillation, regardless of whether they lost weight or how much they lost, according to findings presented at Heart Rhythm 2026.
    • “We were prompted to undertake this study by some encouraging data that … GLP-1 receptor agonists seem to have a favorable effect on reducing the incidence of atrial fibrillation, particularly in patients with metabolic risk factors,” Kenneth C. Bilchick, MD, MS, professor of cardiovascular medicine at the University of Virginia School of Medicine, who presented the findings, told Healio. “I think the results were expected, but they were even better than we thought they would be.”
  • Health Day informs us,
    • For many women, a sudden sneeze or a hearty laugh bring an unwelcome consequence: A small leak of urine. 
      Often dismissed as a normal part of aging or motherhood, new research suggests the real culprit may lie deep within the abdomen.
      A study from the Federal University of São Carlos (UFSCar) in Brazil found that hidden fat stored between internal organs is a major driver of stress-induced urinary incontinence.
      The research — published recently in the European Journal of Obstetrics & Gynecology and Reproductive Biology — suggests that where a woman carries her weight matters far more than the number on the scale.
      Stress urinary incontinence occurs when everyday actions like coughing, lifting or exercising put too much pressure on the bladder, causing urine to leak.
      “It’s that urinary leakage that occurs when pressure inside the abdomen increases and the pelvic floor can’t hold it in,” Patricia Driusso said in a news release. She’s a professor of physical therapy at UFSCar.

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

  • Healthcare Dive reports,
    • “Molina benefited from better controlled Medicaid spending in the first quarter, though steeper membership losses than expected raise questions about whether the insurer can keep costs in hand for the remainder of 2026.
    • “Molina posted better-than-expected first quarter earnings on Wednesday afternoon, sending the insurer’s stock up more than 10% in Thursday morning’s trade.
    • “Yet, unlike its peers UnitedHealth and Elevance, which both raised 2026 guidance after keeping medical spending in check, Molina elected to reaffirm its outlook.
    • “Executives said retaining the current 2026 guidance is prudent given it’s early in the year and the cost environment remains challenging. Still, they hinted Molina might update the outlook after the second quarter.”
  • Fierce Healthcare relates,
    • “Elevance Health’s top brass told investors Wednesday that the insurer is on pace to end the second quarter of 2026 with about 1.2 million members in its individual market plans.
    • “CEO Gail Boudreaux said on the company’s earnings call that the company saw “moderately stronger retention” in the Affordable Care Act segment through Q1, and that it was one of the contributing factors to its better-than-expected results in the quarter.
    • “The membership growth in the individual market plans reflected a shift toward bronze tier coverage following the expiration of enhanced premium tax credits at the beginning of this year, said Chief Financial Officer Mark Kaye. Part of why this trend contributed to lower medical costs is that utilization in these plans is frequently backloaded, he said.” * * *
    • “Kaye said that the company feels good about its position in the ACA market, and the shift to bronze tier plans has been positive in certain markets. However, the company is still taking a prudent approach to forecasting around the ACA market.”
  • Beckers Hospital Review identifies “eight health systems that recently had their outlooks upgraded by Fitch Ratings or Moody’s Investors Service in 2026.”
  • MedTech Dive tells us,
    • “Boston Scientific slashed its 2026 sales growth and earnings guidance on Wednesday as key businesses are facing challenges and setbacks.
    • “The medtech company expects full-year sales growth in a range of 7% to 8.5%, down from a range of 10.5% to 11.5% given in February. Boston Scientific also lowered its adjusted earnings per share guidance from a range of $3.43 to $3.49 to a range of $3.34 to $3.41.
    • “CEO Mike Mahoney told investors on an earnings call that the lowered guidance reflects challenges in several prominent businesses, including electrophysiology and the company’s Watchman franchise.
    • “This was a guide down that we, quite frankly, are not proud of, but we think it’s the right thing to do, and best reflects the current environment,” Mahoney said.”
  • Beckers Health IT informs us,
    • “OpenAI has introduced ChatGPT for Clinicians, offering free use of the tool to all verified U.S. physicians, nurse practitioners, physician assistants and pharmacists.
    • Here are [four] things to know from an April 22 news release and past Becker’s reporting:
      • “1. The AI developer said the solution can help clinicians with tasks like documentation, writing and medical research, freeing up time for patient care.
      • “2. OpenAI has previously launched ChatGPT for Healthcare, an enterprise solution for health systems, and ChatGPT for Health, a tool for users to ask health-related questions.
      • “3. The company also debuted HealthBench Professional⁠, a benchmarking application for three use cases: care consultation, documentation and writing, and medical research.
      • “4. OpenAI said its physician advisors review the AI’s healthcare responses “every few minutes” and before releasing ChatGPT for Clinicians tested nearly 7,000 conversations in their daily work, rating 99.6% of responses as accurate and safe.”
  • Healthcare Dive adds,
    • “The American Medical Association is urging Congress to create safety guardrails for artificial chatbots in mental healthcare, as Americans increasingly turn to the technology for health information and advice. 
    • “In letters sent Wednesday to the chairs of three congressional committees on digital health and AI, the major physician lobby said “well-designed, purpose-built” tools could help patients who would otherwise struggle to access mental healthcare, but that the lack of safety protocols poses serious risks.
    • “Privacy concerns, risks of emotional dependency on AI and reports the tools could encourage self-harm signal that “immediate attention is required to ensure these tools do not inadvertently harm individuals seeking mental health support or companionship,” AMA CEO Dr. John Whyte wrote.”

Monday report

David Ermer–CMS, Congress, COVID-19 vaccine, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Tomorrow at 11 am ET, the House Appropriations Committee will consider its subcommittee’s print of the appropriations bill for financial services and general government, including the Office of Personnel Management for the fiscal year ending September 30, 2027.
  • The subcommittee’s print includes the standard appropriations provisions exempting FEHB and PSHB carriers from full Cost Accounting Standards coverage (Sec. 611) and limiting abortion coverage to cases when carrying the fetus to term would endanger the mother’s life or the pregnancy results from rape or incest (the Hyde amendment, Secs. 613, 614). The bill (Sec. 761) also states “None of the funds made available by this Act, or in any previous appropriation, may be provided for in insurance plans in the Federal Employees Health Benefits program to cover the cost of surgical procedures or puberty blockers or hormone therapy for the purpose of gender affirming care.” The bill no longer includes the contraception mandate that OPM treated as overridden by the ACA’s contraception mandate. 
  • Federal News Network reports,
    • “The Office of Personnel Management and the General Services Administration — the federal government’s human resources office and landlord, respectively — are embarking on plans to move under one roof.
    • “GSA will temporarily relocate to OPM’s headquarters, the Theodore Roosevelt Federal Building, starting in July, while GSA’s 1800 F St. headquarters goes through a renovation.
    • “In December 2028, GSA will move back into its renovated headquarters, along with OPM. Once consolidation is complete, GSA says it will initiate an “accelerated disposal” of OPM’s old headquarters building.” * * *
      “The first Trump administration proposed merging OPM and GSA into a single agency, but ultimately walked away from those plans. In addition to managing a governmentwide real estate portfolio, GSA provides contracting and IT support to other federal agencies.
    • “OPM Director Scott Kupor said there are no talks of a possible merger of the two agencies.”
  • and
    • “House and Senate Democrats are urging the Office of Personnel Management to halt its plans for collecting detailed medical data on potentially millions of enrollees in the government’s health insurance programs.
    • “Citing “significant legal, ethical and security concerns,” two recent letters sent to Trump administration officials identified potential legal violations and the possibility of targeting enrollees across the Federal Employees Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) programs.
    • “The collection of broad, personally identifiable data regarding medical care and treatment raises concerns that OPM could target certain federal employees seeking vital health care services that the administration disagrees with on political grounds,” House Democrats on the Oversight and Government Reform Committee wrote in an April 17 letter, addressed to OPM and the Office of Management and Budget.
    • “This proposal is another step in the stated goal of traumatizing the federal workforce,” Senate Democrats, led by Sens. Adam Schiff (D-Calif.) and Mark Warner (D-Va.), wrote in a separate April 19 letter to OPM Director Scott Kupor. “We are deeply concerned this information will be used in employment actions, including actions related to hiring, suitability determinations, appeals, reductions in force, disability accommodation requests, labor-management relations and performance reviews.”
  • Roll Call adds,
    • “Senate Republicans plan to release their budget resolution and take a procedural vote as early as Tuesday, kicking off the cumbersome process for a reconciliation bill designed to help end the partial shutdown of the Department of Homeland Security.
    • “Senate Majority Leader John Thune, R.S.D., said Monday he hopes to confine the bill to the narrow mission of funding Immigration and Customs Enforcement and the Border Patrol. “
  • HR DIve relates,
    • “Secretary of Labor Lori Chavez-DeRemer resigned on Monday, she confirmed in a post to her official X account, ending her tenure after just over one full year leading the U.S. Department of Labor.
    • “Chavez-DeRemer’s departure followed recent reports that the agency’s inspector general had launched an investigation into her potential misconduct, including contact between her family and department staff. Similar previous inquiries reportedly led to the departure of employees including Chavez-DeRemer’s chief of staff and deputy chief of staff.
    • “Chavez-DeRemer said in her post Monday that under her watch, DOL “created new pathways to mortgage-paying jobs, prepared workers to excel in the age of AI, took steps to lower prescription drug costs, promoted retirement security, and so much more.” A White House spokesperson did not immediately respond to a request for comment.”
  • The American Hospital Association News tells us
    • “Centers for Medicare & Medicaid Services Administrator Mehmet Oz, M.D., and CMS Deputy Administrator and Director of Medicaid and CHIP Dan Brillman sat down with Bill Gassen, president and CEO of Sanford Health and AHA chair-elect, for a discussion about the changes that have occurred in CMS in the past year, as well as how they intend to move forward.  
    • Oz described the agency’s focus this year on working with insurers to reduce the need for prior authorizations. In addition, both Oz and Brillman spoke on the agency’s drive to reduce unnecessary spending; Oz estimated that 5% of CMS’ budget, or about $100 billion, is lost to fraud, waste and abuse.  
    • “Brillman spoke on the new community engagement standards that require most Medicaid recipients to perform a certain number of employment or volunteer hours to maintain their eligibility for benefits, which Brillman said provides “paths to prosperity” for beneficiaries, saying, “if we get someone a higher income so they no longer need services, that’s a win for all Americans.” 
    • “Technology, especially the use of artificial intelligence, was also acknowledged as an important advancement, with Oz saying that current technology offers “a generational opportunity to fix health care,” noting that “I do not see a way to make health care as great as it could be without AI.”  
    • “Oz spoke on last year’s Rural Health Transformation Fund, saying that the infusion of $50 billion over five years will have nationwide effects. “The learnings will accrue to urban centers,” he said. “[The fund] is creating a sandbox in rural areas, and what you learn will benefit all of you.” 

From the public health and medical / Rx research front,

  • Health Day reports,
    • “Reaching for the salt shaker could have long-lasting implications for your memory and brain health, a new study says.
    • “Higher sodium intake appears to affect episodic memory, the type of memory used to recall personal experiences and specific events from your past, researchers report in the June issue of the journal Neurobiology of Aging.
    • “This effect – which could cause one to forget anything from where they parked the car to their first day of school – occurred mainly among men, researchers found.
    • “No such associations were observed among women in the study, researchers said.”
  • The American Medical Association lets us know seven things patients should know about protein maxxing.
  • Healio relates,
    • “Prescriptions for direct-acting antivirals to treat hepatitis C virus in the U.S. have declined substantially since 2015 and remain well below the approximately 260,000 annual treatment courses needed to meet the target for elimination.
    • “Results of a national cross-sectional analysis showed annual treatment volume trending alongside HCV infection rate, rather than surpassing it.
    • “We’re roughly treating the same number of people each year as there are new infections,” Sanjay Kishore, MD, assistant professor at University of Virginia School of Medicine, told Healio. “We’re essentially just holding steady and not actually making any progress.” * * *
    • “I think we need to think creatively about using things like mobile clinics to take care of people. We need to really lean into telehealth on this issue, and we need to expand screening to places where people are getting addiction treatment. Maybe instead of a hospital, it’s a rehab facility or a syringe exchange. We need to make it easier to connect with clinicians and get treatment to meet people where they are.”
  • MedPage Today tells us,
    • “Adults whose type 2 diabetes was treated with GLP-1 receptor agonists were more than likely to develop cognitive impairment over 10 years than their counterparts not treated with GLP-1 agents, a propensity-matched retrospective study of nearly 65,000 patients suggested.”
  • and
    • “Lower hemoglobin levels were linked with higher dementia risk over 9 years of follow-up.
    • “Anemia was associated with elevated Alzheimer’s blood biomarkers including p-tau217 and neurofilament light chain.
    • “Dementia risk was highest when anemia coexisted with abnormal Alzheimer’s biomarkers.”
  • BioPharma Dive offers news from the annual meeting of the American Association for Cancer Research and informs us,
    • “An experimental autoimmune drug from Nektar Therapeutics helped people with alopecia areata who’d already responded to the treatment in a Phase 2 trial grow more hair as time went on, the company said Monday.
    • “The data released Monday measured hair regrowth after 52 weeks of treatment with the therapy, known as rezpegaldesleukin. Nektar disclosed last year that the therapy failed to show a statistically significant benefit over a placebo after 36 weeks. The company, though, blamed that result on the inclusion of four patients that shouldn’t have been eligible and said the findings supported additional development.”
  • Fierce Pharma points out,
    • “Sanofi’s protein-based vaccine Nuvaxovid has conquered Moderna’s next-generation messenger RNA shot mNexspike in a head-to-head trial assessing the tolerability of the two COVID vaccines.
    • “In the phase 4 double-blind, real-world study, which included 1,000 adult participants in the United States, Nuvaxovid showed statistically significant fewer side effects across all pre-specified endpoints.
    • “Symptomatic reactions with Nuvaxovid were both milder and shorter than with mNexspike. Additionally, less than 10% of those who received Nuvaxovid experienced severe side effects—such as fatigue, headache or fever which prevented them from conducting their daily activities—compared to 20% of those who got mNexspike. As for injection site symptoms such as pain, redness and swelling, they were more than 75% more frequent for those who received Moderna’s shot.”

From the U.S. healthcare business front,

  • ‘Per a Lockton news release,
    • “Lockton’s eighth annual survey of over 1,700 U.S. employers helps employers compare their benefit strategies with those of other employers -providing benchmark data, highlighting trends, and illuminating new ideas.
    • “As healthcare costs rise and economic pressures mount, cost is a defining reality for employers. The 2026 Lockton National Benefits Survey shows a rapid acceleration of a shift that first took hold last year – cost management decidedly the top priority vs the next ranked priority – attracting and retaining talent. The data shows how employers are searching for an answer to their need for cost containment solutions.
    • “To gain further insights into the 2026 survey findings, you can access the executive summary here.”
  • The Peterson / KFF Health System Trackers identifies recent trends in employer-based health coverage.
    • “Key takeaways include:
      • “In March 2025, 60.0% of the non-elderly, or about 165.6 million people, had employer sponsored insurance or ESI. 
      • “About four in five (80.4%) adult non-elderly workers worked for an employer that offered ESI to at least some employees, a share that has been consistent over recent years. 
      • “The share of workers eligible for ESI at their job declined slightly over the past few years, from 75.3% in March 2023 to 74.6% in March 2025. 
      • “Most eligible workers who do not take up ESI offered at work cite other coverage (63.0%) and cost (30.2%) as the reason.”  
  • Beckers Hospital Review tells us,
    • “As more care shifts outside hospital walls, health system leaders are rethinking how they plan, staff and structure their workforces to support a rapidly expanding ambulatory footprint.
    • “Outpatient services accounted for 57% of hospital revenues in 2024, up from 52% in 2020, according to the American Hospital Association. The AHA’s Sg2 forecasting model projects outpatient volumes will grow another 17% over the next decade. At the same time, many health systems are accelerating ambulatory investments in 2026 to support financial sustainability and expand access closer to home.”
  • MedCity News notes that “Expanding the CJR Model Is a Logical Step in Value Based Care, but Implementation Challenges Remain.”
    • “CMS is proposing to make its joint replacement bundled payment model mandatory nationwide. Experts say it is a logical step, but warn that mandatory participation could be challenging for hospitals to implement.”
  • Healthcare Dive relates,
    • “Physician burnout continues to decline across the U.S., a bright spot for an occupation plagued by heavy workloads, pervasive stress and high stakes. But the improvement is not equal across medical specialties, according to new data from the American Medical Association.
    • “The AMA surveyed thousands of physicians and found that 41.9% reported experiencing a burnout symptom in 2025, down from 43.2% in 2024 and 48.2% in 2023. The decline likely reflects employer efforts to reduce burnout, including by increasing job satisfaction, the medical association said.
    • “However, burnout rates vary significantly across specialties, and tend to be higher among doctors employed by hospitals, suggesting health systems could be doing more to ameliorate the phenomenon.”
  • Fierce Healthcare informs us,
    • “UnitedHealthcare is building on its work to support rural hospitals and will now exempt these facilities from most prior authorizations.
    • “The insurance giant said in an announcement on Monday that the shift will apply across all lines of business. In addition, UHC will accelerate payments by up to 50% for about 1,500 rural hospitals and all critical access hospitals across the country.”
  • and
    • “Just over two years ago, Highmark joined forces with Spring Health to launch a new mental well-being platform that made it far easier for members to access critical services.
    • “Now, the partners are offering a look at how that program has worked for members. In a paper published last month, researchers at Highmark reported that patients waited less than two days on average in 2025 to access an appointment.
    • “Spring’s platform is embedded directly into Highmark’s member app, and that integration was a key part of what made the program work, according to the analysis. Members can easily find mental well-being tools and complete a self-assessment upon connecting for the first time, which allows Spring to build a personalized approach.”
  • The Wall Street Journal points out,
    • “Eli Lilly struck a deal to acquire Kelonia Therapeutics for $3.25 billion upfront and up to $7 billion if certain milestones are reached. 
    • “Kelonia is developing a next-generation CAR-T therapy for multiple myeloma, which promises to transform treatment without chemotherapy.
    • “The acquisition positions Eli Lilly to enter a lucrative segment of the global cancer-drug market and bolster its cancer offerings.”
  • MedTech Dive adds,
    • “Medtronic said Monday it has closed the acquisition of CathWorks, a deal worth $585 million with potential undisclosed earn-out payments.
    • “The transaction, agreed to in February, continues a strategy of increasing acquisitions to strengthen the company’s leadership in its core businesses, Medtronic said.
    • “CathWorks’ FFRangio system uses artificial intelligence and computational science to assess the entire coronary tree from routine angiograms that image the blood vessels.”

Midweek update

David Ermer–ACA, CMS, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–

From Washington, DC,

  • OPM Director Scott Kupor added another post to his excellent Secrets of OPM blog today. This one is titled “Simplicity is a Virtue.” In the FEHBlog’s opinion, OPM should focus on simplifying its administration of the FEHB and PSHB programs.
  • The FEHBlog noticed on the following rulemakings currently under Office of Management and Budget review:
  • The FEHBlog is concerned about the OPM rule because OPM has not implemented the HIPAA 820 electronic enrollment roster transaction that would allow carriers to reconcile individual enrollees with their premiums. What is the sense of having a pristine family member list without knowing whether the enrollee is paying the correct premium. The HIPAA 820 also would give carriers earlier notice about enrollees who have left federal employment and annuitants who have passed away.
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced the 2026 KidneyX EMPOWER Prize Challenge, a $4 million national competition to accelerate innovation supporting living kidney donors and patients who depend on them. To further enhance nephrology care, HHS will also support data standardization and health information technology improvements across the kidney care ecosystem. The challenge will be run through the Kidney Innovation Accelerator (KidneyX).”
  • The Wall Street Journal reports,
    • “One in seven people who signed up for Affordable Care Act plans this year failed to pay after premium costs rose sharply, according to an analysis that provides the first comprehensive look at the impact of expiring federal subsidies. 
    • “Nationally, around 14% of those who enrolled in ACA plans this year didn’t pay their first monthly bill for January coverage. In some states, the share was a quarter or more, according to a new analysis from the actuarial firm Wakely Consulting Group, provided exclusively to The Wall Street Journal.
    • “It’s a big drop,” said Michelle Anderson, a Wakely consulting actuary. 
    • “Normally, the rate of falloff in ACA plan membership early in the year is in the midsingle-digit range.”

From the Food and Drug Administration front,

  • The Washington Post reports,
    • “The Food and Drug Administration is taking the first step toward potentially allowing compounding pharmacies to produce seven peptides that are currently restricted because of the agency’s previous warning over safety concerns.
    • “The agency’s expert advisory panel on pharmacy compounding is scheduled to discuss whether the peptides should be used in compounding for purposes for ulcerative colitis, wound healing, inflammatory conditions, obesity, insomnia and more, according to a Federal Register notice posted Wednesday announcing a late-July meeting.”

From the judicial front,

  • Bloomberg Law reports,
    • “A federal appeals court vacated an order rejecting a request to block a Maryland drug discount law, remanding the decision for review, in a victory for AbbVie Inc., Novartis AG, AstraZeneca Plc, and PhRMA.
    • “The US Court of Appeals for the Fourth Circuit ruled that a lower court “erred” when it denied the drugmakers’ motion for a preliminary injunction against Maryland’s H.B. 1056.
    • “The decision was driven by a recent order from the Fourth Circuit that upheld a block on West Virginia’s version of the contract pharmacy law, with the majority opinion stating that “West Virginia passed a materially similar statute, which this Court recently held is likely preempted”.

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Many scientists have contended that humans have evolved very little over the past 10,000 years.
    • A few hundred generations was just a blink of the evolutionary eye, it seemed. Besides, our cultural evolution — our technology, agriculture and the rest — must have overwhelmed our biological evolution by now.
    • “A vast study, published on Wednesday in the journal Nature, suggests the opposite. Examining DNA from 15,836 ancient human remains, scientists found 479 genetic variants that appeared to have been favored by natural selection in just the past 10,000 years.
    • “The researchers also concluded that thousands of additional genetic variants have probably experienced natural selection. Before the new study, scientists had identified only a few dozen variants.
    • “There are so many of them that it’s hard to wrap one’s mind around them,” said David Reich, a geneticist at Harvard Medical School and an author of the new study.” * * *
    • “Nandita Garud, a geneticist at the University of California, Los Angeles, who was not involved in the new study, said that unearthing natural selection over the past 10,000 years could do more than just illuminate our deep history.
    • “Scientists still don’t know much about how genetic variations influence our health. When they find a link between a genetic variant and a disease, Dr. Garud said, it will be important to see whether it has been favored by natural selection.
    • “That might give you a clue that this is important,” she said.”
  • The Wall Street Journal relates,
    • “Vertigo and dizziness, often caused by dislodged inner-ear crystals (BPPV), are common age-related problems increasing fall risk.
    • “Emergency-room visits for vertigo commonly result in unnecessary diagnostic tests and sedative medications, potentially worsening patient outcomes.
    • “Researchers are investigating links between BPPV and migraines, low vitamin D, and osteoporosis, while developing new rehabilitation treatments.”
  • Fierce Healthcare tells us,
    • “Behavioral health utilization increased substantially from 2018 to 2024, with anxiety disorder care fueling much of that growth, according to Trilliant Health. 
    • “The health data analytics and market research firm’s latest report outlines a 62.6% jump in behavioral health utilization, based on any visit associated with a behavioral health diagnosis code.
    • “Between 2008 and 2024, the prevalence of mental illness increased by almost 6 percentage points. About a quarter of adults had any mental illness in 2024, Trilliant found, though in adults 18-25 exhibit the highest prevalence both in terms of any mental illness (33%) and serious mental illness (16%). 
    • “Anxiety disorders accounted for the highest visit volume and experienced the fastest growth, up 89% from 2018 to 2024. Anxiety disorders in women aged 18-44 were also the highest utilization category in 2024. 
    • “It’s possible those figures are increasing because more screening is happening, acknowledged Trilliant Health Chief Research Officer Allison Oakes, Ph.D.”
  • Medscape adds,
    • “Utah’s pilot program using AI for psychiatric medication refills raises safety and compliance concerns. Critics argue it lacks transparency, proper research, and may violate FDA laws, emphasizing the need for licensed physician oversight.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Studying mice, researchers at Toronto’s Sinai Health have found that semaglutide—the active ingredient in popular weight loss drugs that mimic the gut hormone GLP-1—acts directly on a subset of liver cells to improve organ function, and does so independently of weight loss. The finding challenges long-held assumptions about how GLP-1 medicines work in the liver and could reshape how physicians treat metabolic liver disease.
    • “Headed by Daniel Drucker, MD, a senior investigator at the Lunenfeld-Tanenbaum Research Institute, the team reported on their findings in Cell Metabolism, in a paper titled “The weight-loss-independent hepatoprotective benefits of semaglutide are orchestrated by intrahepatic sinusoidal endothelial GLP-1 receptors.”\
  • Per Multiple Sclerosis News,
    • “People with diabetes are significantly more likely — with nearly 60% higher odds — to develop multiple sclerosis (MS) than those without the metabolic disease, which is marked by high blood sugar levels, according to a new systematic review and meta-analysis.
    • “A significant association was also observed specifically between type 2 diabetes, the most common form of the condition, and MS risk.
    • “The analysis did not, however, find clear evidence that MS increases the likelihood of developing diabetes.
    • “Current evidence indicates that [diabetes mellitus], specifically [type 2 diabetes], increases the risk of developing MS,” the researchers wrote. “However, a reverse association remains unconfirmed.”
  • Per MedPage Today,
    • “Primary care patients educated about Alzheimer’s disease blood-based biomarkers were generally willing to undergo tests and supported their use, survey data showed.
    • “After patients received a brief explanation of Alzheimer’s blood tests, 94.5% supported offering them to patients with memory complaints, and 85% said they were willing to complete a test if their clinician recommended it, reported Andrea Russell, PhD, of Northwestern University Feinberg School of Medicine in Chicago, and co-authors.
    • “Patients endorsed Alzheimer’s blood tests when they informed medical care (94.2%), were covered by insurance (93.4%), if comprehensive education was received prior to testing (88.5%), and if testing was easy or convenient (88.1%), Russell and colleagues wrote in Alzheimer’s & Dementiaopens in a new tab or window.”
  • Healio adds,
    • “High vitamin D levels in mid-life were associated with lower levels of tau protein in the brain more than a decade later, suggesting a possible modifiable risk factor for Alzheimer’s disease, according to findings in Neurology Open Access.
    • “Previously, it was known that low circulating vitamin D in later life is associated with an increased risk of cognitive impairment and clinical dementia,” Martin D. Mulligan, MBBCh, BAO, a researcher at the University of Galway in Ireland, told Healio.
    • “Most prior studies evaluating the association between vitamin D and cognitive function typically measured circulating vitamin D in older adults,” he continued. What our study adds is a focus on early mid-life.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “The increasing cost of medical care is driving more workers to forgo needed care or stop taking medications, ADP found in a recently released employee benefits survey. 
    • “Twenty-six percent of respondents said they’d skipped needed medical care for themselves or a family member due to out-of-pocket costs (compared to 21% in 2020), 22% have stopped taking or taken less medication (compared to 17% in 2020), and 15% declined vision or dental insurance so they could afford medical insurance. 
    • “The finding “points to the need for simpler plan design, clearer education and flexible options that reflect different budget preferences,” ADP observed. “Employers can play a stronger role in helping employees make cost-conscious choices without compromising care.”
  • Fierce Healthcare relates,
    • “Average physician pay rose about 3% between 2024 and 2025, from $374,000 to $386,000—outpacing the 2.7% U.S. core inflation rate that rounded out the year, a new annual report from Medscape found.
    • “Medscape’s 2026 Physician Compensation Report surveyed 5,916 physicians across more than 29 specialties. Total compensation numbers reflect base salary and incentive bonuses, plus other income sources like profit-sharing contributions, as reported by full-time physicians.
    • “Matthew Wells, Ph.D, a senior director at AGMA Consulting, called 2025 a “return to normalization” for physician compensation in the report and expects “consistency with increases” in the future. Driving factors cited by Wells include physician productivity in seeing more patients and improved technology-driven efficiency. 
    • “Fifty-three percent of all physicians report feeling fairly compensated, as opposed to last year’s report in which only 48% reported fair compensation—what the report notes was the “most dispirited response” it had seen in a decade of posing the question.” 
  • Beckers Hospital Review offers a non-exhaustive list of “32 health systems with strong operational metrics and solid financial positions, according to reports from credit rating agencies Fitch Ratings and Moody’s Investors Service released in 2026.”
  • and lets us know,
    • “The Illinois Health Facilities and Services Review Board approved Ontario, Calif.-based Prime Healthcare’s acquisition of Franciscan Health Olympia Fields (Ill.). 
    • “The 214-bed hospital is expected to transition to Prime on May 1, according to an April 14 news release shared with Becker’s. 
    • “Prime Healthcare entered an agreement in January to acquire the hospital and and Specialty Physicians of Illinois from Mishawaka, Ind.-based Franciscan Alliance. Prime said it plans to offer jobs to “substantially all employees” at Olympia Fields. 
    • “Olympia Fields is set to become Prime’s ninth Illinois hospital and 55th overall. In March 2025, the health system acquired eight Illinois facilities from St. Louis-based Ascension. Prime said that in the first year of ownership, it invested more than $104 million in the eight hospitals to enhance clinical care and operations, modernize infrastructure and expand service lines.” 
  • BioPharma Dive informs us,
    • “Beeline Medicines emerged from stealth Wednesday with plans to develop “precision therapies” for immune diseases, nearly a year after its backer Bain Capital teamed up with Bristol Myers Squibb to give five of the pharma’s experimental medicines a new home.
    • “Beeline’s pipeline is led by the licensed drug afimetoran, a daily oral treatment for systemic lupus erythematosus, a form of lupus, that targets a pair of receptor proteins which are responsible for regulating the immune system. At Bristol Myers, the drug had already been tested in a Phase 1b trial in a different form of lupus. A Phase 2 study is underway and is expected to be completed in the second half of this year, after which Beeline plans to launch “a pivotal development program.”
  • MedTech Dive adds,
    • “Avanos Medical has accepted a $1.27 billion go-private offer from American Industrial Partners, the company said Tuesday. 
    • “AIP agreed to pay a 72.1% premium to Avanos’ closing stock price on Monday. Avanos CEO Dave Pacitti told customers that AIP will back his company to strengthen its competitive position.  
    • “Avanos competes with businesses including Boston Scientific and Cook Medical for the specialty nutrition market, and rivals such as Medtronic and Stryker in the pain management space.”

Tuesday report

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Fierce Healthcare reports,
    • “A prominent physician voice in the House of Representatives has introduced a new bill that would compel insurers to apply the cost for drugs purchased from direct-to-consumer platforms to deductibles and out-of-pocket maximums.
    • “North Carolina Republican Greg Murphy, M.D., on Tuesday unveiled the Every Dollar Counts Act, a bill that aims to lower patients’ out-of-pocket costs for pharmaceuticals. Murphy, a consistent critic of insurers and pharmacy benefit managers, notes in an announcement that consumers have increasingly embraced DTC offerings as costs rise.
    • “Using these platforms, patients can often find prices that cost far less out-of-pocket, especially for branded drugs, per Murphy’s office.”
  • The American Hospital Association News adds,
    • “The AHA and dozens of other organizations April 14 sent a letter of support to Reps. Suzan DelBene, D-Wash., and Mike Kelly, R-Pa., for their introduction of the Chronic Care Management Improvement Act. The bill would waive beneficiary cost-sharing requirements for Medicare beneficiaries receiving chronic care management services. Beneficiaries are currently required to pay a 20% coinsurance fee to receive such services. “This cost-sharing requirement creates a barrier to care, as beneficiaries are being billed for services that do not always include interfacing with their provider, thus creating confusion for patients,” the organizations wrote. “Also, many of these beneficiaries consider any additional out-of-pocket expense for healthcare services untenable.”
  • CMS has posted MMSEA Section 111 GHP User Guide Version 7.8 – April 13, 2026 (PDF)
    • “The GHP User Guide * * * is your primary source for Section 111 GHP reporting requirements.”
  • OPM Director Scott Kupor has added a new post titled “Merit Matters” to his Secrets of OPM blog.
    • “If we want the best talent in the federal government – which I think we do – we should not refuse to hire college dropouts, unless dropping out of college is somehow representative of their ability to work successfully on behalf of the American people. And, if they are in fact world-class engineers, then we should pay them at the level at which they are performing versus force-fitting them into a lower pay level because they have no prior work experience.
    • “Once again, merit matters.”
  • Per an OPM news release,
    • “US Office of Personnel Management (OPM) Director Scott Kupor joined Fox News’ Saturday in America with host Kayleigh McEnany to highlight the launch of EarlyCareers.gov, a new initiative to recruit more early career Americans into federal service and strengthen the government’s talent pipeline.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Even as Eli Lilly gets underway with its next major obesity launch in Foundayo, an FDA document related to the oral treatment shows lingering reservations about multiple “unexpected serious” risks potentially related to the drug.
    • “In the FDA’s approval letter (PDF) for GLP-1 pill Foundayo, the agency tasks Eli Lilly with obtaining more information about the med’s potential link to major adverse cardiovascular events and drug-induced liver injury. In addition, the agency wants to gain more info about delayed gastric emptying associated with the drug and its potential effects in lactating women.
    • “In its assessment of the medicine’s data, the FDA “determined that only a clinical trial (rather than a nonclinical or observational study) will be sufficient to assess a signal of a serious risk of retained gastric contents and to identify an unexpected serious risk for major adverse cardiovascular events (MACE), drug-induced liver injury (DILI), and exposure to [Foundayo] during lactation,” the letter says.”
  • STAT News adds,
    • “In a bid toward greater transparency, the Food and Drug Administration sent reminder letters to more than 2,200 companies and researchers that they are required to report clinical trial results to a federal government database or they may face fines.
    • “FDA officials disclosed that an internal analysis found results were not submitted for nearly 30% of studies that were “highly likely” to fall under mandatory reporting requirements. The agency also noted that the letters were sent to companies and researchers associated with more than 3,000 registered trials, some of which were publicly funded.
    • “In explaining its move, the regulator acknowledged a long-standing complaint from researchers who have argued that without access to specific data, trial results cannot be easily duplicated, and this inhibits greater understanding of how medicines might work. They also contend this can adversely affect treatment decisions and health care costs.”
  • MedTech Dive relates,
    • “Medline is removing certain angiographic syringes from the market due to problems with the devices becoming loose or disconnected.
    • “Medline began the recall in February, and it was posted to the Food and Drug Administration’s website last week. The problem was the subject of a warning letter that Medline received in March, also recently posted to the FDA’s website.” 
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today issued a draft guidance for sponsors seeking approval of human gene therapy products involving genome editing technologies. When finalized, this guidance will provide recommendations for standardized methods for comprehensively assessing the safety of genome editing therapies to bring effective treatments to patients sooner.
    • “Genome editing holds extraordinary promise for treating previously incurable genetic diseases, and today’s announcement represents the FDA’s forward approach to drive innovation and advance the development of genome editing therapies,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This guidance provides sponsors with clear, scientifically-grounded recommendations for evaluating off-target editing risks using state-of-the-art sequencing technologies. We are serious about moving this ball forward.”  
    • “The draft guidance, issued by the Center for Biologics Evaluation and Research, supports the FDA’s framework for accelerating development of individualized therapies for ultra-rare diseases launched in February. The framework revolutionizes how the FDA engages with industry and promotes a path for transformative rare disease treatments.
    • “The “Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing” guidance provides specific recommendations on sequencing strategies, sample selection, analysis parameters, and reporting.”

From the judicial front,

  • Healthcare Dive reports,
    • “A federal [magistrate] judge has tossed an Elevance subsidiary’s lawsuit against billing intermediary HaloMD and several California-based providers alleging they’re abusing the out-of-network billing dispute process set up by the No Surprises Act.
    • “[Magistrate] Judge Karen Scott of the Central District of California dismissed the suit on Monday, finding that Anthem Blue Cross, Elevance’s California subsidiary, failed to prove that the companies were gaming the law’s independent dispute resolution, or IDR, in order to inflate their reimbursement.
    • “It’s a major win for HaloMD, which is facing similar lawsuits from Elevance in three other states and has found itself in hot water over its status as the No. 1 submitter of IDR disputes. The Texas-based company cheered the court’s decision, while Elevance said it plans to appeal.”
    • Yesterday, Anthem Blue Cross did appeal the court’s decision to the U.S. Court of Appeals for the Ninth Circuit.
  • Bloomberg Law reports,
    • “A Delaware judge threw out lawsuits seeking to link the heartburn drug Zantac to cancer, freeing makers of the product from facing trials in the state over the cases.
    • “Superior Court Judge Francis “Pete” Jones concluded Monday lawyers for ex-Zantac users couldn’t produce legitimate evidence backing up claims the over-the-counter product caused cancer. Zantac is currently made by French drugmaker Sanofi.” * * *
    • Because former Zantac owners GSK Plc, Pfizer Inc., Sanofi and Boehringer Ingelheim Pharmaceuticals already have settled thousands of Zantac suits over the last several years, it’s unclear how many Delaware cases will be dismissed by Jones’ order. GSK paid more than $2 billion in 2024 to resolve what it said was more than 90% of its pending cases.

From the public health and medical / Rx research front,

  • Fierce Healthcare reports,
    • “Seven in 10 U.S. adults gamble, according to a survey from the National Council on Problem Gambling (NCPG). Commercial gaming revenue broke records at $78.7 billion in 2025, with over $18 billion in tax revenue going into state and local coffers. All gaming segments, from casinos to sports betting to online games (iGaming), are growing. Throw in prediction markets, which allow users to speculate on the outcome of real-world events but are not legally considered gambling platforms, and the betting buffet becomes basically limitless. 
    • “This menu of options is creating an addiction crisis yet to be widely recognized by the public, policymakers and the healthcare sector, experts caution. Current national problem gambling prevalence is unknown due to a lack of research and funding dedicated to the issue. States that measure and publish their own prevalence rates see anywhere from 1% to 6%. Those most at risk include young adults, men and online gamblers. Gambling-related harms can be dire, from financial stress to co-occurring behavioral health conditions to suicide, which a fifth of individuals with gambling addiction attempt.
    • “To understand problem gambling, what’s driving it and efforts underway to address it, Fierce Healthcare talked to two dozen providers, researchers, advocates and regulators. This story is also based on a review of research, as well as exclusive data from Komodo Health analyzed on Fierce Healthcare’s behalf.
    • “It’s a small but mighty group of us that have been in this field, treating,” said Jody Bechtold, L.C.S.W., president of the International Problem Gambling and Gaming Certification Organization (IPGGC). “We call it the next opioid epidemic.” 
  • Healio tells us,
    • “The risk for subsequent fractures is similar for older adults, regardless of whether they had an initial major osteoporotic fracture or nonmajor osteoporotic fracture, researchers reported.
    • “In findings published in Journal of Bone and Mineral Research, researchers found that sustaining a major or nonmajor osteoporotic fracture raises the risk for subsequent fractures and mortality.”
  • Infectious Disease Advisor informs us,
    • “Rhinovirus and enterovirus are associated with severe clinical outcomes among hospitalized patients, including mechanical ventilation and death, highlighting the need for expanded respiratory virus surveillance among high-risk patient populations.”
  • MedPage Today points out,
    • “A dual deprescribing intervention for proton pump inhibitors (PPIs) targeting patients and their primary care doctors proved effective in reducing potentially inappropriate use, a cluster-randomized trial in France found.
    • “At 1 year, the combined approach — where patients got educational material about reducing PPI use mailed to them and their physicians received a letter detailing a deprescribing algorithm — resulted in twice as many patients cutting their PPI use in half (14.9%) versus usual care (7%) or physician-targeted intervention alone (7.7%, P<0.001 for both).
    • “The results underscore “the value of prioritizing patient-facing deprescribing strategies,” wrote researchers led by Jean-Pascal Fournier, MD, PhD, of Nantes Université in France, in JAMA Internal Medicineopens in a new tab or window. Furthermore, the interventions were not associated with a resurgence in gastroesophageal reflux disease (GERD) symptoms.
    • “PPIs in the U.S. are frequently prescribed for inappropriate indications and sometimes prescribed indefinitely, according to Fournier and colleagues.” * * * Potentially unnecessary PPI spending — reimbursements in 2015 hit $12 billion in the U.S.

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

  • Modern Healthcare reports,
    • “The Purchaser Business Group on Health, which represents large companies, launched a project to combine federally required data with claims data culled from its biggest members to provide insight into costs and quality in employer-sponsored health plans.
    • “This has the potential to supply employers with unprecedented access to healthcare pricing data that could help curb escalating employee health benefit costs, said Purchaser Business Group on Health President and CEO Elizabeth Mitchell.
    • “There is employer demand for this information that is unmet in the market,” Mitchell said during a Purchaser Business Group on Health webinar on healthcare transparency in February.
    • “The Purchaser Business Group on Health has found that normal market forces that should be expected to link prices to quality don’t function in healthcare. Prices often fluctuate wildly based more on the size and market power of health systems or insurers than on the quality of services rendered.
    • “For instance, its data reveal prices at hospitals in the same markets do not correlate with scores from the Leapfrog Group, which assesses hospital quality and safety. Often, low-rated hospitals charge more. Or the same hospital charges vastly different prices for the same procedures depending on the insurance plans, not any differences in the service.” 
  • and
    • “Health systems are increasing their investments in concierge medicine to meet patient demand and keep burned-out doctors practicing.
    • “Though typically a small percentage of a health system’s operations, concierge medicine — where patients pay thousands of dollars in membership fees for increased access to primary care physicians — helps diversify revenue and creates growth opportunities in new and existing markets.
    • “Still, it’s a controversial model that raises questions about equal access to care because it historically has appealed to wealthier, often older individuals looking for more personalized primary care. Health systems say patient demand has expanded beyond that demographic.”
  • Fierce Healthcare relates,
    • “Anthem and Mount Sinai have reached a new multi-year contract agreement, restoring coverage for thousands after the system went out-of-network last month.
    • “Anthem Blue Cross and Blue Shield of New York said in a statement Monday that the three-year deal returns Mount Sinai’s hospitals, physicians and other providers to its network. The health plan said that the contract “reflects both organizations’ commitment to delivering quality care while helping control healthcare costs for New York workers, families, employers and taxpayers.”
    • “The contract also includes updated reimbursement models that aim to reward quality and outcomes, while continuing to support accurate billing and payment.”
  • The Wall Street Journal lets us know ,
    • Healthcare giant Johnson & Johnson JNJ reported nearly 10% revenue growth for the latest quarter on strong cancer drug sales that offset a steep decline from one of its bestselling drugs, Stelara.
    • J&J said its first-quarter sales rose to $24.06 billion, topping the mean estimate of $23.62 billion from analysts surveyed by FactSet. Adjusted quarterly earnings also beat Wall Street expectations.
    • On the back of those results, the drug and medical-device maker boosted its full-year financial forecast. So far, disruptions from the war in Iran haven’t materially hurt J&J.
    • “There’s a lot of macro uncertainty out there,” J&J Chief Financial Officer Joseph Wolk said in an interview. “We think the fact that we’re not only maintaining but raising” the forecast is a sign of the company’s strength, he added.
    • J&J has been working to ensure consistent growth after losing patent protection for Stelara, a treatment for skin and digestive conditions. Competitors introduced lower-cost alternatives last year, leading to a 60% drop in first-quarter sales of the brand-name version of the drug.
    • Strong sales of J&J cancer medications like multiple-myeloma treatment Darzalex helped make up for those declines. The company’s cancer-drug sales rose more than 22% for the quarter. J&J is in a stronger position than some of its peers, which face even bigger patent cliffs in coming years.
  • BioPharma Dive tells us,
    • “Eli Lilly is again turning to dealmaking to boost its oncology portfolio, reaching a deal Tuesday to acquire a biotechnology company, CrossBridge Bio, that’s developing newer types of targeted cancer medicines.
    • “Lilly will pay up to $300 million in cash for CrossBridge, a Houston-based startup making antibody-drug conjugates for cancer. That total includes an unspecified upfront payout and subsequent payment tied to a development milestone, CrossBridge said in a statement.
    • “The deal hands Lilly technological capabilities that have become increasingly desirable to major pharmaceutical firms. Antibody-drug conjugates, or ADCs, are now a pillar of cancer care, a method of precisely delivering a toxic blow to malignant cells. Over 20 ADCs are currently available to treat tumors of the breast, lung, bladder and more. Many are working their way into earlier treatment lines, in some cases supplanting decades-old chemotherapy approaches.”
  • MobiHealth informs us,
    • “New York-based virtual women’s health provider Maven Clinic announced a strategic collaboration with care concierge company Wellthy to combine clinical care and caregiving support for employees.
    • “Maven Clinic is a digital reproductive health and family platform that offers fertility and family planning services, pregnancy and postpartum care, parenting and pediatric support, and menopause-related care.
    • ‘Wellthy offers a care concierge service that connects employees with care teams to help them navigate the healthcare system, including finding in-home support, understanding benefits, accessing legal resources and obtaining financial assistance.
    • “The company also offers Backup Care services to help employees find emergency care for family members, including daycares, on-site childcare facilities and other community-based programs.    
    • “The aim of Maven and Wellthy’s partnership is to help employees in the “sandwich generation, – those in the period of starting a family and caring for an older loved one – navigate the process from fertility, growing a family and overseeing eldercare.
    • “This partnership is about building a system that reflects how people live, with clinical care and caregiving support together in one place. When technology makes that support intuitive, you don’t just improve outcomes – you make it possible for people to ask for help in the first place,” Kate Ryder, founder and CEO of Maven Clinic, said in a statement.”
  • The Wall Street Journal informs us,
    • “Novo Nordisk NOVO.B said it would work with ChatGPT maker OpenAI on how to leverage artificial intelligence to discover new drugs, the latest AI partnership in the medical field as healthcare companies seek to harness the technology to get ahead of the competition.
    • “The Danish drugmaker said it would integrate OpenAI’s models across its operations to help its workforce analyze complex datasets and reduce the time it takes to move from research to delivering treatments to patients.
    • “The group said the partnership would boost efficiency across manufacturing, distribution, the supply chain and corporate, with pilot programs initially launching in research and development, manufacturing and commercial operations ahead of a full AI integration by the end of the year.” * * *
    • “Drugmakers are turning to AI companies and their increasingly powerful models to improve operations and cut repetitive tasks for employees, giving them more time to focus on R&D in a bet that advancements in the technology will help them identify promising new drugs and treatments.”
  • Modern Healthcare adds,
    • “Health systems and payers are making big investments in artificial intelligence to improve their operations by reducing administrative burden, beefing up clinical prediction capabilities and increasing access to care. 
    • “A case in point: This year alone, UnitedHealth Group is investing $1.6 billion into its AI efforts. Companies also are realigning executive roles by adding chief AI officers or adding AI responsibilities to C-suite executives overseeing data and innovation.” * * *
    • “Mike Baker, chief operating officer, UnitedHealthcare
    • “UnitedHealth Group, our parent, has embedded the use of AI across our business to simplify healthcare and improve how people access care, information and support. UnitedHealth Group is investing $1.6 billion this year with the aim of making experiences more personalized, reducing administrative friction for clinicians, increasing transparency around cost and coverage, and supporting better care decisions.” 

Monday report

David Ermer–CMS, Congress, FDA, Generative AI, HSA, Medicare, NIH, OPM, Rx coverage, U.S. Healthcare–

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.”
  • Bloomberg Law informs us,
    • “Senate Republicans aren’t planning to include Medicare and Medicaid changes in the next partisan spending package—instead focusing it largely on ending the partial government shutdown.
    • “Top Republicans plan to use a bill that advances through the simple-majority budget reconciliation process to fund immigration enforcement and US Border Patrol and would not require Democrats’ support.
    • “Though some Republicans have been pushing for including Medicare and Medicaid policies in the package, the narrow focus does not leave room for other priorities, Senate Majority Leader John Thune (R-S.D.) said Monday. He said budget instructions will not be sent to the Senate Finance Committee.” * * *
    • “But he didn’t rule out returning to other health care policies. For instance, he mentioned a provision blocking federal Medicaid payments from going to Planned Parenthood, which was included in the 2025 tax-and-spending law and sunsets in July, as a possible candidate for inclusion.”
  • 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.”