Midweek report

Electronic health records

Midweek report

David Ermer–Congress, COVID-19, Electronic health records, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • FedWeek reports,
    • “OPM has sought to allay privacy concerns about its plan to access detailed medical information on FEHB/PSHB enrollees, with one of the organizations that raised such concerns—the National Active and Retired Federal Employees Association—cautiously optimistic that OPM is addressing them.
    • “In a Federal Register notice posted in December, but which only drew attention months later in April, OPM proposed to gain access to carriers’ records including office visits, treatment, prescriptions and other medical information, without a requirement that they withhold personally identifying information.” * * *
    • “He said that OPM’s inspector general’s office—which has access to such information for its audits of health plans and carriers—“will provide an encrypted copy of that data to OPM – but only after stripping out names, social security numbers, phone numbers, addresses (except for ZIP codes), and other personally identifiable data. The only member-level PII fields that will remain in the data that OPM receives will be our member’s ZIP codes, year of birth, and their member ID.”
    • “He said that OPM further will replace the member ID with random numbers and characters and that the data “will remain in a secure, separate environment, encrypted at rest and protected with our IT security best practices.”
  • FEHBlog note: At least for HIPAA privacy rule purposes, an anonymous identifier cannot be based on an actual ID number as OPM plans. Moreover, to avoid re-identification, OPM should arrange for a third party to create the anonymous identifier properly and then arrange for the OIG to insert the anonymous identifier into the claims records before they are sent to OPM.
  • Per a Senate news release,
    • “Today the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee voted to favorably report several bills making health care more affordable and accessible to American families. During the markup, U.S. Senator Bill Cassidy, M.D. (R-LA), Chairman of the HELP Committee, led Republicans in rejecting Ranking Member Bernie Sanders’ (I-VT) attempt to sabotage the bipartisan bills with toxic poison pill amendments.
    • “I understand why Americans are frustrated with Congress. If we want Congress to work, we have to make it work,” said Dr. Cassidy. “I want part of my legacy [to be] he tried to preserve the institution. But that is a responsibility of us all.”
    • “I appreciate my colleagues’ efforts and will continue to work with Republicans and Democrats to enact a pro-patient, pro-family agenda,” continued Dr. Cassidy.
    • “The Charlotte Woodward Organ Transplant Discrimination Prevention Act, Healthy Start Reauthorization Act, Stem Cell Therapeutic and Research Reauthorization Act, EARLY Act Reauthorization, Accelerating Access to Critical Therapies for ALS Act, and the Biosimilar Red Tape Elimination Act passed unanimously as amended in an en bloc vote. The Medication Affordability and Patent Integrity Act also passed in a 16-6 vote.”
  • The American Hospital Association News relates,
    • The Department of Health and Human Services June 17 announced it will provide more than $700 million in funding for initiatives on mental illness, addiction and homelessness. Funding opportunities include $96 million for the Safety Through Recovery, Engagement, and Evidence-based Treatment and Support Program, or STREETS; $223.1 million for comprehensive community-based behavioral healthcare programs; $238.6 million for the 988 Suicide and Crisis Lifeline; $80 million for substance use prevention, treatment and recovery initiatives; and more than $70 million for mental health services and support programs. 
  • Beckers Hospital Review tells us,
    • “The Trump administration has begun enforcing federal information-blocking regulations against healthcare organizations that fail to provide patients with access to and exchange of their electronic health information, Politico reported June 17.
    • “Thomas Keane, assistant secretary for technology policy at HHS, told the publication that the agency has stepped up enforcement of data-sharing requirements as part of broader efforts to improve healthcare accessibility and affordability.
    • “Congress directed HHS to address information blocking through the 21st Century Cures Act, which was enacted in 2016. Rules implementing the law were finalized in 2020, and penalties were established in 2024.” * * *
    • “We have started issuing notices of nonconformity to information blockers,” Mr. Keane said. “We’ve had people come back to us and tell us: ‘Yes, we were information blocking.’” Mr. Keane said healthcare organizations may have financial or competitive incentives not to share patient information, but federal law requires health information to be shared for the benefit of patients.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in patients 5 years of age and older. Approved in time for the 2026–2027 flu season, this approval reflects the Trump Administration’s commitment to increasing the availability of generic drugs.
    • “Today’s approval marks a meaningful milestone for the treatment of influenza,” said Iilun Murphy, M.D., Director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research. “Expanding patient access to drugs and improving their ease of use are critical public health imperatives, particularly given that influenza alone accounts for millions of illnesses in the U.S. each year.”
    • “Generic baloxavir marboxil tablets may be used for:
      • ‘Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours, and who are otherwise healthy or at high risk of developing influenza-related complications; and
      • “Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza.”
  • MedPage Today adds,
    • “The FDA approved oral tebipenem pivoxil (Utebzi) as the first oral carbapenem antibiotic to treat complicated urinary tract infections (UTIs), the agency announced on Wednesday.
    • “Tebipenem pivoxil is indicated for complicated UTIs, including pyelonephritis, caused by the susceptible microorganisms Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca, and Enterococcus faecalis, in adults who have limited or no alternative oral treatment options.” * * *
    • “Tebipenem pivoxil should be available to U.S. patients by the end of 2026, GSK said.”
  • BioPharma Dive tells us,
    • “UniQure, the Netherlands-based biotechnology company, intends to formally ask the Food and Drug Administration to approve its for Huntington’s disease gene therapy now that the two parties are more aligned on the closely watched treatment.
    • “UniQure said Wednesday that, during a recent meeting, FDA staff agreed three years of data gathered from a key trial of the therapy would be enough to support an approval application. As such, the company expects to file one sometime between July and the end of September. The FDA has requested another trial be conducted to confirm the treatment’s effects and, according to the UniQure, the agency wants to make sure both sides see eye to eye on this study’s design before a marketing application gets submitted.”
  • The American Hospital Association News informs us,
    • “The Food and Drug Administration June 16 announced that a nationwide shortage of stereotactic breast biopsy needles is expected to last through the end of March 2027. The FDA said the shortage is due to a manufacturing disruption and that clinical management adjustments may be required for patients needing a breast biopsy. Healthcare providers are recommended to conserve their use of stereotactic breast biopsy needles. The agency said that Hologic issued a customer letter Jan. 2 that said all lots of its Brevera Breast Biopsy System Disposable 9 Gauge Needle were being removed due to a risk of metal and plastic particles being dislodged from the device during use.” 

From the judicial front,

  • Healthcare Dive reports,
    • “OhioHealth has reached a proposed settlement with state and federal regulators over allegations that the Columbus, Ohio-based system strong-armed insurers into anticompetitive contracts.
    • “The deal announced Tuesday voids problematic OhioHealth contracts and prevents the system from seeking such terms in the future, according to the Department of Justice.
    • “OhioHealth, which has maintained its contracting practices are legal, did not have to admit wrongdoing as part of the settlement. The system also will not pay any penalties or fines.”
  • Fierce Healthcare tells us,
    • “The Pharmaceutical Care Management Association has joined some of the nation’s largest pharmacy benefit managers in challenging Tennessee’s new law governing the industry.
    • “The Volunteer State’s new policy would prevent PBMs from also owning or being affiliated with pharmacies operating in the state. State lawmakers argue that the law would bring greater transparency and fairness to the market, particularly to support independent pharmacies.
    • “CVS Health, parent company of “Big Three” PBM Caremark, was the first to sue over the law in late May, with Express Scripts following suit late last week.”
  • The Wall Street Journal relates,
    • Luigi Mangione will mount a psychiatric defense at his New York state trial for the killing of UnitedHealthcare Chief Executive Brian Thompson, a judge said Wednesday.
    • During a hearing in state court in Manhattan, Judge Gregory Carro said the lawyers discussed the defense strategy at a sealed proceeding earlier this month. The judge said defense lawyers intend to argue that Mangione killed the insurance executive due to an extreme emotional disturbance at the time. * * *
    • The state trial of Mangione, 28 years old, is scheduled to begin on Sept. 8. A psychiatric defense would significantly alter the nature of the trial because his lawyers would acknowledge he killed Thompson, but argue he did it because he was emotionally disturbed. If a jury agrees with that argument, his murder charge would be downgraded to manslaughter, resulting in a shorter potential prison term.
    • Mangione faces headwinds at trial, including a journal found in his backpack that prosecutors will likely use to argue that he planned the murder for months. “Extreme emotional disturbance is about a loss of self-control for which there was a reasonable explanation or excuse,” said Gary Galperin, a former prosecutor in Manhattan who now teaches at Cardozo School of Law. “The classic case is, you come home and find your spouse in bed with someone else.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “During the most recent respiratory virus season, the risk of hospitalization was higher for influenza than for COVID-19, per a US Department of Veterans Affairs (VA) study of nearly 13,000 patients.
    • “The authors, from the VA Saint Louis Health Care System, noted that while COVID-19 was tied to a substantially greater risk of hospitalization than flu early in the pandemic, data showed an increase in flu cases and hospitalizations in 2025-26 compared with previous seasons.
    • “The findings were published last week in The Lancet Infectious Diseases.
    • “However, population-level metrics reflect both infection frequency and disease severity and cannot alone determine the relative clinical severity of one pathogen versus another,” they wrote. “A head-to-head comparison of hospitalisation risk among infected individuals—which isolates disease severity from differences in infection frequency—has not been undertaken for the 2025–26 influenza season.”
  • Health Day relates,
    • “Folks are told that once you start taking Ozempic or Zepbound, you’ll need to stay on them to maintain the drugs’ benefits.
    • “But patients prescribed such GLP-1 drugs are more likely to stop them and then restart use later than was previously assumed, according to research presented Sunday at the Endocrine Society’s annual meeting in Chicago.
    • “We found that about 4 in 10 patients stopped their GLP-1 medication within the first year, and nearly 6 in 10 had stopped by the end of two years,” based on insurance records from more than 60,000 Americans with type 2 diabetes, said study investigator Sainikhil Sontha. He’s a research associate at Boston University School of Public Health.
    • “However, not everyone who stopped taking their GLP-1 remained off it.
    • “More than half of those who stopped restarted therapy within a year (42%), and nearly two-thirds did so within two years (58%),” Sontha said in a university news release. “This suggests that for many patients, these medications aren’t being abandoned permanently; use is more start-and-stop than most people assumed.”
  • and
    • Solid organ transplant survival is improving, but organ shortages persist, according to a study published in the July issue of the Journal of the American College of Surgeons.
  • and
    • “At-home blood pressure monitoring can lower risk of heart attack and stroke
    • “People participating in a remote monitoring program had a 34% lower risk of heart attack, stroke and heart disease
    • “Their readings were forwarded to a doctor, who kept tabs on their blood pressure.”
  • The Washington Post lets us know,
    • “As a doctor, I tell people to do these 4 things to reduce age-related muscle loss
    • “Resistance training, protein and recovery remain the most powerful tools for preserving strength and independence later in life.”
  • The latest NIH Research Matters covers the following topics:
    • Immune system may attack nervous system in some Long COVID patients
      • “Researchers linked antibodies that attack the body’s nervous system to some neurological symptoms of Long COVID.
      • “The results may point to possible treatments for some people with Long COVID.”
    • Depression screening using video games
      • “A study suggests that the unconscious way the brain assesses rewarding experiences is miscalibrated in patients with depression. 
      • “Game-like tasks to measure this mechanism could help doctors screen patients more quickly for depression.”
    • AI tool could speed antibiotic development
      • “Researchers developed and tested a system to improve the antibacterial effects of existing compounds.
      • “This system could help quickly create new antibiotics to overcome antibiotic resistance.”

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

  • The Wall Street Journal delves into state of the U.S. healthcare business.
  • Beckers Hospital Review ranks 40 health systems based on their first quarter 2026 operating margins, and tells us,
    • “Nashville, Tenn.-based Ascension Saint Thomas has broken ground on a $148.5 million hospital and healthcare campus in Clarksville, Tenn., expanding its presence in one of the state’s fastest-growing regions. 
    • “The 96-acre campus will include a full-service hospital that will open with 44 inpatient beds and expand to 132 beds as demand grows. The hospital will be St. Louis-based Ascension’s 19th in Tennessee, according to the health system’s website. 
    • “The hospital will offer emergency care, inpatient surgery, cardiology, neurosciences, women’s health, neonatal intensive care, oncology and orthopedic services. The broader campus will also feature physician offices, an inpatient rehabilitation hospital, outpatient surgery, advanced imaging and specialty ambulatory care services.”
  • BioPharma Dive informs us,
    • “Jazz Pharmaceuticals is enlisting the help of AbCellera in a bid to develop next-generation T-cell-engaging medicines to treat solid tumors.
    • “As part of a deal announced Wednesday, Jazz will pay AbCellera $56 million up front in exchange for discovery work and early-stage preclinical research on two programs. AbCellera also committed to start a third discovery program within 12 months, which will trigger another $28 million payment, and may undertake two additional projects if both companies agree.
    • “If Jazz exercises options for development, AbCellera could earn as much as $792 million more per program in fees and payments for reaching certain development, regulatory and commercial milestones. AbCellera would also be eligible for royalties, should any approved medications come out of the collaboration.”
  • Fierce Healthcare points out,
    • “Fitness wearable company Whoop announced Wednesday a partnership with health platform HealthEx that allows users to connect their medical records directly within the Whoop app, combining medical history with biometric data.
    • “The companies say the partnership “responds to a growing need” for “more connected health experiences” for users. The new integration allows various factors—such as chronic conditions, recent procedures and more—to be considered alongside tracking metrics, like performance and sleep. 
    • “Whoop has always focused on turning data into meaningful insights,” said Alex Vannoni, Whoop’s head of healthcare product, in a statement. “This partnership extends that approach by bringing medical history into the Whoop experience, giving members a more complete view of their health and enabling even more personalized, relevant coaching, grounded in who they are, not just what happened on a given day.”
    • “The integration is enabled by the Whoop AI and My Memory features. The artificial intelligence-driven My Memory feature, announced last month, allows users to provide context to manage personalized coaching.”
  • Beckers Payer Issues notes,
    • “Payers often work with employers, but they have to keep their own staff happy, too. 
    • “Amid a climate of payers across the country cutting jobs, Centene recently confirmed it is offering buyouts to most employees as its ACA business contracts. Against that backdrop, employee morale and retention have become pressing priorities for health plan leaders.
    • “Becker’s spoke with Sidecar Health’s chief people officer, Alex Coonce, and Elevance Health’s chief human resources officer and executive vice president, Ryan Craig, to learn about the biggest concerns for today’s health plan employees — and how each company is tackling them.”

Thursday report

David Ermer–CDC, CMS, Congress, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, Patient safety, U.S. Healthcare, Uncategorized–

Simplicity is a virtue.

A commenter, Patrick Morselli, accurately observed in response to the OPM Director’s blog post that “Simplicity has a high cost in most organizations. Feels like the hardest work is undoing complexity other smart people left behind.”

From Washington, DC

  • The Wall Street Journal reports,
    • “Senate Republicans broke with President Trump over his administration’s plan to create a $1.8 billion settlement fund to pay people who claim political persecution, with widespread opposition forcing party leaders Thursday to abandon votes on immigration-enforcement funding and send lawmakers home early for their Memorial Day break.
    • “The “anti-weaponization” fund is a Trump priority, after he alleged for years that his supporters, including those prosecuted over the Jan. 6, 2021, attack at the Capitol, had been targeted unfairly by the Biden administration. But its creation has run into blowback in the Senate, and the immigration-enforcement bill gave senators leverage to dig in their heels.
    • “I don’t like the fund at all,” said Sen. John Curtis (R., Utah), who added he didn’t think any guardrails could fix it. Sen. Thom Tillis (R., N.C.), a frequent target of Trump criticism who is retiring, called it a “payout pot for punks.”
    • “With no resolution in sight, Senate Majority Leader John Thune (R., S.D.) sent senators home for their weeklong Memorial Day recess, putting the Republican-led Congress on course to miss Trump’s deadline to have the Immigration and Customs Enforcement and Border Patrol measure on his desk by June 1.”
  • Healthcare Dive relates,
    • “Lawmakers are mulling reform of how Medicare pays physicians, concerned that insufficient reimbursement in the federal insurance program is incentivizing consolidation and increasing healthcare costs.
    • “Physician pay has declined over the past two decades when accounting for inflation, spurring independent providers to be acquired by hospital systems rather than go it alone, provider witnesses told representatives during a House Energy and Commerce subcommittee hearing Wednesday. And representatives agreed that’s a concern.
    • “Making sure that independent physician practices stay open […] is one of the most critical ways we can ensure competition and drive down costs,” said Rep. Kim Schrier, D-Wash.”
  • The American Hospital Association adds,
    • “Rep. Randy Feenstra, R-Iowa, introduced the Rural Maternity Options for Medical Support Act on May 19. The bill would guarantee that beds used solely for labor and delivery are not counted toward the 25-bed limit for critical access hospitals. The bill is co-sponsored by Reps. Darin LaHood, R-Ill., Jill Tokuda, D-Hawaii, and Kim Schrier, D-Wash. 
    • “New and expecting moms deserve access to high-quality labor and delivery services,” said Lisa Kidder Hrobsky, AHA senior vice president for advocacy and political affairs. “The Rural Maternity Options for Medical Support Act of 2026 strengthens access to maternal health services for mothers in rural areas by ensuring that higher volume critical access hospitals have labor and delivery beds available, even if their other patient beds are full. The AHA appreciates Rep. Feenstra’s leadership to support critical access hospitals and families across the nation.” 
  • and
    • “The House Education and Workforce Committee May 21 unanimously passed the Transparency in Billing Act (H.R. 8684). The bill would require off-campus hospital outpatient departments to obtain a separate unique health identifier and include it on all claims for services billed to commercial group health plans or their enrollees. The legislation would prohibit the health plan from paying the claim and the hospital from collecting payment from the plan enrollee if the claim excludes the identifier, and it would impose civil monetary penalties on hospitals that violate the requirement. 
    • The AHA has previously opposed this policy, saying that hospitals are already transparent about the location of care delivery on their bills and that it would create a significant administrative burden to providers and the health care industry at large.” 
  • Fierce Healthcare tells us,
    • “Health and Human Services Secretary Robert F. Kennedy Jr. removed two key leaders of the U.S. Preventive Services Task Force (USPSTF), a key advisory panel that offers guidance on preventive services, according to media reports.
    • ‘Vice chairs John Wong, M.D. and Esa Davis, M.D. were dismissed from the task force in letters sent to them by Kennedy on May 11, The New York Times reported on Wednesday, citing copies of the letters obtained by reporters. STAT, CNN, Politico and The Hill also reported the terminations, citing the letters.” * * *
    • “The terminations leave the panel with just eight sitting members. Five other members saw their terms expire at the start of this year, and Kennedy did not replace them, and the previous chair, Michael Silverstein, departed on his own, STAT reported.”
  • Federal Network News informs us,
    • “Shane Stevens, the top official for the Office of Personnel Management’s healthcare and insurance arm, is stepping down from his role, Federal News Network has learned.
    • “Stevens, a political appointee, has been serving as associate director of healthcare and insurance at OPM since last summer. He announced in an email Thursday afternoon that he is voluntarily resigning, effective immediately.”
  • Best wishes, Mr. Stevens. Thanks for your service.
  • Tammy Flanagan, writing in Govexec, lets us know “what federal employees get wrong about divorce and retirement.”
    • “Errors involving survivor benefits, health coverage and court orders can create financial problems years after a marriage ends.”
  • FedWeek explains “Insuring Children at College and Federal Benefits Considerations (with a Checklist).”

From the Food and Drug Administration front,

  • Radiology Business reports,
    • “Medtronic is recalling more than 18,000 surgical devices due to a risk of contamination. The recall includes certain lots of the company’s Gundry and DLP retrograde cannulae, which are cardiopulmonary bypass vascular catheters used to perform open heart surgeries.
    • “This recall was put in place due to the potential of a sterile barrier breach. Only certain lots of these devices are included in the recall.
    • ‘The U.S. Food and Drug Administration (FDA) has ruled this as a Class II recall. This means the agency believes these devices could cause “temporary or medically reversible adverse health consequences.”
  • STAT News relates,
    • “Wearable maker Whoop has not resolved a dispute with the Food and Drug Administration over a blood pressure feature the company launched last year, according to a top health executive at the company. 
    • “FDA warned Whoop last July over the feature that gives users a daily estimate of their systolic and diastolic blood pressure, saying that it’s a medical device that requires agency review. Whoop argues that the feature is exempt from FDA review because it is intended for wellness purposes.” * * *
    • “The dispute between FDA and Whoop turned up the heat in a simmering debate about how the agency ought to oversee low-risk products. Proponents of deregulation argue that the time and expense required for FDA authorization impede innovation and that FDA review is unnecessary to ensure the safety of many products that potentially benefit consumers.”

From the judicial front,

  • Federal News Network reports,
    • “Some federal employees may now have an easier time qualifying for disability retirement benefits, following a recent precedential decision from the U.S. Court of Appeals for the Federal Circuit.”
    • “In April, the court ruled that federal employees’ disability retirement applications cannot be denied solely based on a lack of “objective” medical evidence. The ruling applies in cases where federal employees have already been removed from their jobs due to a “medical inability to perform.”
    • “Objective documentation, like lab tests or prescription lists, can support an argument but cannot be the sole basis for denying claims, the court said. “Subjective” medical evidence, like a diagnosis based on self-described symptoms, must also be considered. If employees’ disability retirement claims rely on subjective evidence, they won’t automatically be denied benefits.
    • “The decision last month overturned a 2024 ruling from the Merit Systems Protection Board, which had upheld the Office of Personnel Management’s denial of a disability retirement application from a former OPM employee in 2016.”
  • The New York Times relates,
    • “The Justice Department announced charges on Thursday against 15 people for attempting to defraud Minnesota Medicaid and other social service programs in the state of more than $90 million. 
    • “Top officials, including Robert F. Kennedy Jr., the health and human services secretary, and Mehmet Oz, head of the Centers for Medicare and Medicaid Services, appeared in Minneapolis to announce the charges. “The fraud here in Minnesota is shocking,” said Colin McDonald, an assistant attorney general overseeing the administration’s crackdown on fraud.
    • “Among the defendants are an owner and an employee of autism clinics, who are charged with submitting $46.6 million in fraudulent claims to Medicaid, the public health plan that covers low-income people. Additional defendants were charged with filing bogus claims to Medicaid for other services, including those that assist disabled people with obtaining housing and living independently.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The world’s most popular weight-loss and diabetes drugs are linked to a powerful new possible benefit: better outcomes for cancer patients. 
    • “A suite of four new studies suggest that people taking so-called GLP-1 drugs like Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro saw reductions in tumor progression, lower overall chance of death and less risk of developing breast cancer.
    • “It’s really provocative that they showed, in several cancers, that people who took these drugs seem to have a lower risk of their cancer returning,” said Dr. Jennifer Ligibel, a breast oncologist at the Dana-Farber Cancer Institute who wasn’t involved in any of the studies.
    • “One study from researchers at the Cleveland Clinic Cancer Institute tracked more than 10,000 patients with early-stage cancers who started GLP-1 drugs after diagnosis and compared their disease progression to those on a different diabetes medication. Those on GLP-1s were less likely to see their cancer spread.
    • “In lung cancer patients, the rate of progression to advanced disease was cut roughly in half—10% in GLP-1 users versus 22% in the comparison group. Breast cancer patients showed a similar pattern, with progression rates of 10% versus 20%. Colorectal and liver cancers also showed statistically significant reductions.”
  • and
    • “An investigational drug developed by Eli Lilly LLY  delivered clinically meaningful weight loss in a trial, the company said as it looks to expand its obesity treatment portfolio amid soaring demand.
    • “Lilly said Thursday that retatrutide, designed to be taken once a week, met the primary endpoint in a phase 3 clinical trial, as well as key secondary endpoints.
    • “According to Ania Jastreboff, a Yale School of Medicine professor and lead investigator for the trial, every dose of retatrutide assessed resulted in clinically meaningful weight reduction for nearly all participants. On average, those with severe obesity on the highest dose lost 30% of their body weight over two years, Jastreboff added.
    • “The trial evaluated the therapy’s efficacy and safety on adults who are overweight and had other medical conditions such as type 2 diabetes, chronic pain and cardiovascular issues.
    • “More results will be shared later this year, Lilly added.”
  • Healio adds,
    • “Studies show that GLP-1 receptor agonists have significant potential for treating glaucoma, diabetic retinopathy and other eye diseases, but important nuances remain to be investigated, according to a review published in BMC Ophthalmology.
    • “Although GLP-1 RAs have revolutionized metabolic disease management, their potential therapeutic role in ocular diseases — particularly those driven by shared metabolic and inflammatory pathways — remains underexplored,” Yu Luo, of Beijing University of Chinese Medicine, and colleagues wrote. “Their multifaceted neuroprotective properties and anti-inflammatory mechanisms present a distinctive therapeutic opportunity for ophthalmic pathologies, potentially offering direct ocular benefits beyond systemic metabolic control.”
  • and
    • “Adults with obesity achieved greater long-term weight loss if they partook in a nutrition plan designed for rapid weight loss compared with one designed for gradual weight loss, according to trial data.
    • “Line Kristin Johnson, RD, PhD, senior researcher at Vestfold Hospital Trust in Norway, said there has been debate among researchers regarding whether rapid weight loss leads to worse long-term outcomes for people with obesity. In findings from a randomized pragmatic trial presented at the European Congress on Obesity, Johnson and colleagues found implementing a calorie-restricted eating pattern for rapid weight loss can induce a larger decrease in body weight at 1 year than a gradual weight-loss eating pattern.”
  • Endocrinology Advisor points out,
    • “Life-course body size progression, particularly transitioning from a thinner childhood body size to adult obesity, significantly increases risks for stroke, coronary artery disease, and heart failure.”
  • Healio also notes,
    • “Only a third of cancer survivors receive advice on weight control and improving their diet from health care professionals, and less than half are informed about the benefits of physical activity.
    • “Individuals who do receive advice on losing weight, salt and fat intake, and exercise are three to eight times more likely to engage in healthy behaviors than those who did not.
    • “We need more effort to deliver lifestyle behaviors to patients,” Chao Cao, PhD, MPH, instructor in the department of medical oncology at Dana-Farber Cancer Institute, told Healio.”
  • Fierce Pharma tells us,
    • “Phase 3 data for Merck & Co. and Kelun-Biotech’s antibody-drug conjugate sacituzumab tirumotecan (sac-TMT) suggest the race is heating up to establish a new standard of care in first-line non-small cell lung cancer.
    • “According to an abstract released ahead of the ASCO 2026 annual meeting, combining the TROP2-directed ADC with Keytruda slashed the risk of disease progression or death by a major 65% compared with Keytruda alone in treatment-naïve, PD-L1-positive NSCLC. The p-value is below 0.0001, suggesting high statistical significance.
    • “Key overall survival results, which will underpin regulatory considerations in first-line NSCLC, were not mature at the Sept. 29, 2025, data cutoff, but a strong trend with a preliminary 45% improvement in favor of the combo arm was observed.” 
  • Per MedPage Today,
    • “Undetected attention deficit-hyperactivity disorder (ADHD) was not uncommon among adults hospitalized after traffic accidents, according to a cross-sectional study from the Dominican Republic.
    • ‘Among 95 adults admitted for traffic-related injuries without a prior diagnosis, more than a third (34.7%) screened positive on the Adult ADHD Self-Report Scale, reported Amanda Abreu, MD, of the Universidad Iberoamericana in Santo Domingo, Dominican Republic.
    • “High-risk driving behaviors — including violations, mistakes, and slips — were more common among adults who screened positive (66.6% vs 30.6%, P=0.0016), she reported at the American Psychiatric Association annual meeting.
    • “We’re not saying that ADHD alone caused the accidents, nor are they unsafe drivers, but these findings suggest that this is a really vulnerable population we should look into, and we should help protect,” Abreu said.”
  • and
    • “Low-risk pancreatic cystic lesions were found to be associated with a long-term risk of pancreatic cancer in a retrospective cohort study.
    • “The incidence rate of pancreatic cancer among patients with pancreatic cystic lesions was higher than that of the general population (1.89 vs 0.14 per 1,000 person-years).
    • ‘Over a quarter of patients were diagnosed with pancreatic cancer more than 5 years after detection of lesions, suggesting longer-term follow-up is needed to avoid missed diagnoses.”
  • Per the Wall Street Journal,
    • “New French research links natural food color additives to increased risks of Type 2 diabetes and cancer, similar to synthetic dyes.
    • “Beta-carotene, curcumin and anthocyanins used as color additives were linked to a higher risk of Type 2 diabetes. Beta-carotene used as a food coloring was also linked to breast cancer.
    • “The findings challenge the Trump administration’s push for natural dyes and food companies’ shift away from artificial colors.”
  • Per BioPharma Dive,
    • “BioMarin is looking to expand the use of its top-selling medicine, Voxzogo, with positive study results released Wednesday.
    • I’n 2021, Voxzogo became the first drug approved to improve growth in children with achondroplasia, the most common form of dwarfism. The new results pertain to a related condition called hypochondroplasia that generally presents in less severe ways and might not be noticed until later in a child’s life.
    • ‘In the Phase 3 trial, researchers found participants given Voxzogo were growing faster than those who received a placebo. After a year, the Voxzogo patients also had significant increases in standing height and arm span, a key finding that could help children function better in daily tasks and retain more independence.”

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

  • Managed Healthcare Executive reports,
    • ‘For the average person, healthcare costs rose 7.9% in 2026 to $8,460, which is the highest annual increase in more than a decade, according to the 2026 Milliman Medical Index
      (MMI). For a hypothetical family of four, healthcare costs reached $37,824, Milliman found. The Milliman Medical Index measures healthcare costs covered by a typical employer-sponsored health insurance plan.”
    • “The increase reflects structural forces that are not going away, Milliman Principal and Consulting Actuary Deana Bell said in a news release. “Outpatient costs have quadrupled for the MMI’s family of four since the MMI was first published in 2005, with much of the trend exacerbated by delivery system consolidation, specialty drug growth, and site-of-care shifts.”
  • Beckers Hospital Review relates,
    • “The National Council of State Boards of Nursing found the District of Columbia has the most licensed nurses per capita, while Utah is the state with the fewest for the second year in a row.
    • “The organization created a course of nursing licensure statistics in the U.S. and its territories. The data was compiled using the NCSBN’s database and Nursys, an electronic information system where regulatory bodies enter licensure data. All of the council’s 58 members shared licensure data, which amounted to 6,903,665 registered and practical nurses — up from 6,870,362 last year.
    • ‘According to the data, Wyoming and Vermont had the fewest licensed nurses in their states overall, at 9,620 and 13,528, respectively. Meanwhile, California and New York had the most licensed nurses at 708,141 and 610,207, respectively.” 
  • Healthcare Dive tells us,
    • “Nonprofit health system Providence is throwing in the towel on the majority of its health insurance businesses, citing the difficulty of running a regional health plan amid regulatory pressures and rising costs.
    • “Starting next year, Providence, which covers about 440,000 people in a handful of western states, will no longer offer Medicaid, Affordable Care Act or employer-sponsored plans, the Renton, Washington-based system announced on Wednesday.
    • ‘The decision comes as Providence attempts to shore up its financial footing and refocus on delivering care. Still, the company plans to maintain its Medicare Advantage operations through a partnership with a national carrier, according to the release.”
  • Modern Healthcare tells us,
    • “Sutter Health and Allina Health have moved a step closer to joining forces.
    • “Sacramento, California-based Sutter and Minneapolis-based Allina said Thursday they signed a definitive agreement to form a $26 billion combined system with 39 hospitals. The agreement follows a letter of intent announced in March. The proposal is on track to close by the end of the year pending customary regulatory approval, the organizations said in a news release.” 
  • BioPharma Dive informs us,
    • “Eli Lilly has snagged Engage Biologics, a biotechnology company that aims to deliver genetic medicines without viral payloads, in a deal worth up to $202 million.
    • “Lilly said Wednesday it has acquired the preclinical biotech in an all-cash deal, including an undisclosed upfront payment, with the possibility of future payouts based on research, development and commercialization milestones. The acquisition gives Lilly non-viral DNA delivery technology, dubbed the “Tethosome” platform.
    • “We believe that the combination of Engage’s platform with Lilly’s significant capabilities will meaningfully accelerate development of new genetic therapies,” Will Olsen, co-founder and CEO of Engage, said in a statement.”
  • Fierce Healthcare lets us know,
    • “Electronic medical record (EMR) company Canvas Medical launched Canvas Studio Thursday, a no-code interface that allows clinicians and other healthcare professionals to build custom EMR workflows.
    • “Canvas Medical CEO Adam Farren told Fierce Healthcare the company was “serving a market” for software developers to customize workflows for end users within its ONC-certified EHR platform. 
    • “What Studio does is replace the developer with an AI agent, so that the end user, the clinician or administrative staff user, can directly customize and extend Canvas themselves using the agent,” Farren said.”
  • and
    • “Employers are set to significantly increase their use of AI in health benefits, a new survey shows, even as they continue to face barriers to rolling out the tech.
    • “WTW polled 312 employers with about 4.6 million workers for the 2026 AI Use in Health and Benefits Survey, and found that 72% of those surveyed plan to embed AI into their benefits programs in the next two years. By comparison, only 20% said they are currently doing so.
    • “The employers cited several key areas where they see AI likely supporting benefits at work, such as improved communication, cited by 68%, and data insights and analytics, noted by 59%. In addition, 57% of those surveyed said AI would likely support greater personalization.
    • “Jeff Chandler, North America commercialization leader for Health & Benefits at WTW, said in a press release that these top priorities are all “areas where AI can materially improve how benefits teams make decisions and support employees.”

Monday report

David Ermer–CDC, Electronic health records, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The Washington Post reports,
    • “President Donald Trump on Monday announced that about 600 low-cost generic drugs would be available through TrumpRx.gov, a government website aimed at helping Americans purchase medications at discounted prices. 
    • “By incorporating this massive catalog of low-cost generics at TrumpRx.gov, consumers will now have one source to ensure that they’re getting the lowest possible cost on their prescription,” Trump said in a presentation at the Eisenhower Executive Office Building.”
  • Federal News Network relates
    • “HHS sends RIF notices to dozens of staff it missed during office-wide layoffs last year.
    • “Meanwhile, HHS is looking to convert hundreds of senior positions to a rebranded version of the “Schedule F” classification for federal employees.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a reorganization of its Office for Civil Rights (OCR), the Department’s law enforcement agency charged with enforcing laws protecting civil rights, conscience and religious freedom, and health information privacy and security. The reorganization returns OCR to a program-based structure that aligns OCR’s three critical substantive areas with three distinct subject-matter divisions: the Conscience and Religious Freedom Division, the Civil Rights Division, and the Health Information Privacy, Data, and Cybersecurity Division.
    • “This reorganization restores the HHS Civil Rights Division and the Conscience and Religious Freedom Division and strengthens the Office for Civil Rights’ ability to defend religious liberty, enforce conscience protections, and combat unlawful discrimination,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “Under President Trump’s leadership, HHS will defend these rights with clarity, accountability, and resolve.”
    • “This reorganization reinstitutes a structure that rightly prioritizes civil rights and conscience and religious freedom alongside health information privacy and security,” said HHS Office for Civil Rights Director Paula M. Stannard. “All three areas are deserving of subject-matter expertise and distinct senior executive leadership for OCR to best serve the American people.”
  • The American Hospital Association News adds,
    • “Most hospital outreach laboratories must report private payer clinical diagnostic laboratory data for services furnished during the first six months of 2025 to the Centers for Medicare & Medicaid Services by July 31, the agency announced. This includes Healthcare Common Procedure Coding System codes, associated private payer rates and volume data. CMS previously sent letters to hospitals, which the agency believes have outreach laboratories that are likely required to report their data. CMS also has a guide and other resources for hospital outreach laboratories to determine whether and how they must report.” 

From the Food and Drug Administration,

  • The Wall Street Journal reports,
    • “AstraZeneca AZN said it received U.S. approval for a new hypertension treatment, getting the green light to launch a drug the U.K. pharmaceutical company expects to generate multibillion-dollar annual sales at its peak.
    • “The drug, known until now as baxdrostat, will be marketed under the brand name Baxfendy, the company said Monday. The approval expands AstraZeneca’s cardiovascular, renal and metabolism portfolio shortly after diabetes drug Farxiga—its biggest product in that therapeutic area and the bestselling medicine in the company’s history—went off patent in the U.S.
    • “AstraZeneca said that Baxfendy treats hypertension in a new way by targeting aldosterone, a hormone that raises blood pressure.
    • “Ruud Dobber, executive vice president of AstraZeneca’s biopharmaceuticals business, said the approval brings a new treatment to a disease that has had little therapeutic progress for the past two decades.”
  • Fierce Pharma relates,
    • “Enhertu’s market conquest is continuing apace. Already tracking at $5 billion in annual sales, the star antibody-drug conjugate from Daiichi Sankyo and AstraZeneca has secured FDA approval to treat early breast cancer, further encroaching on Roche’s Kadcyla territory.
    • “The FDA has simultaneously greenlighted Enhertu for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer, the two companies said Friday [July 15, 2026]. The adjuvant nod came nearly two months ahead of schedule, as the FDA had originally targeted a decision by July 7.”
  • The New York Times tells us,
    • “A California dairy company has issued a recall for five ice cream flavors, warning customers that some tubs may be contaminated with metal.
    • “The company, Straus Family Creamery, recalled some of its organic ice cream, which was sold in 17 states since May 4. It said it ordered the recall because of “the potential presence of metal foreign material,” without giving further details.
    • “The warning applies to its vanilla bean, strawberry, cookie dough, Dutch chocolate and mint chip flavors with specific “best-by” dates in late December 2026.
    • “It did not say how many tubs were affected but said the issue was with a “small number of production runs.”
  • Health Day informs us,
    • “The U.S. Food and Drug Administration (FDA) has approved an AI-powered early warning system to detect sepsis, one of the deadliest infections for hospital patients.
    • “The tool, developed at Johns Hopkins University (JHU), detects sepsis hours faster than doctors. It has already reduced deaths by nearly 20% in dozens of hospitals across the United States, JHU reports.
    • “Pre-suspicion screening is what creates lead time, and lead time is what changes outcomes in sepsis,” said Suchi Saria, director of JHU’s AI & Healthcare Lab. “Once a clinician already suspects sepsis, the clock has been running — often for hours or even days.”

From the judicial front,

  • Bloomberg Law reports,
    • “The US Supreme Court turned away appeals from six pharmaceutical companies seeking to topple the Medicare drug price negotiation program that’s led to billions of dollars in discounts on top-selling treatments.
    • “Making no comment, the justices on Monday refused to hear a variety of constitutional arguments against a program created in 2022 by President Joe Biden’s Inflation Reduction Act. The court rejected separate appeals from units of AstraZeneca Plc, Johnson & Johnson, Bristol Myers Squibb Co., Novartis AG, Novo Nordisk A/S and Boehringer Ingelheim Pharmaceuticals Inc.
    • “The rebuffs leave in force a program the US government said in November will produce a 71% discount on Novo Nordisk’s blockbuster Ozempic and Wegovy drugs for Medicare patients starting in 2027. The Trump administration said that round of discounts, covering 15 drugs, will mean $12 billion in savings compared with 2024 list prices.
    • “The cases at the high court involved the previous year’s negotiated discounts, which covered 10 drugs and took effect in January. The Centers for Medicare and Medicaid Services said in 2024 that the deals would reduce out-of-pocket costs by $1.5 billion this year.”
  • Per a Justice Department news release,
    • “A New York man was sentenced today to 37 months in prison for conspiring to launder nearly $1.5 million in illicit health care fraud proceeds through multiple domestic and global banks on behalf of a Transnational Criminal Organization (Organization).
    • “According to court documents, Elnar Zarbailov, 42, of Staten Island, New York, and dual citizen of the United States and Azerbaijan, was a fixer and money launderer for the foreign-based  Organization that spearheaded the largest health care fraud case ever prosecuted by the Department of Justice, as uncovered by Operation Gold Rush. The Organization, based in Russia and elsewhere, orchestrated a multi-billion-dollar health care fraud and money laundering scheme to target, exploit, and steal from Medicare and private health insurance companies.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “The CDC announced Monday that an American tested positive for Ebola this weekend while working in Congo and is being transported to Germany for treatment along with six other Americans who are high-risk contacts. 
    • “The Centers for Disease Control and Prevention also is enhancing public health screening and traveler monitoring amid a growing Ebola outbreak, and non-U.S. passport holders face entry restrictions if they have been to Uganda, the Democratic Republic of Congo or South Sudan in the previous 21 days.
    • “To the American public, the risk to the United States remains low,” said Satish Pillai, CDC Ebola response incident manager. “Travelers to the region should avoid contact with sick people, report symptoms immediately, and follow our travel guidance.”
  • Health Exec points out,
    • “A healthcare research firm that provides trend analysis to stakeholders released a new report that examined usage of behavioral health services post-COVID, showing that demand and utilization for mental healthcare and addiction mitigation have intensified since the pandemic.
    • “According to the data from Trilliant Health, while the utilization of care related to emotional health, mental health, autism, and alcohol and drug dependency stand at new highs since the COVID lockdowns, outcomes may not be improving.
    • “Using publicly available data on utilization, provider numbers and demand, Trilliant’s data paints a picture of a mental healthcare system that is overburdened. From 2018 to 2024, the group reports that the number of behavioral health visits jumped 62.6%, standing at 1,346 visits per 1,000 people.
    • “People seeking care for anxiety led the trend, accounting for 89.3% of growth. Women aged 18-44 made up the majority of that cohort. However, Trilliant noted that childhood developmental disorders—autism, attention deficit disorder, speech problems and other issues including anxiety—including attempted self-harm, have risen nearly 48% over 20 years, from 2004-2024.”
  • Health Day adds,
    • Many older adults see cannabis as a more effective or nonpharmaceutical option to manage sleep, pain, or mental health, according to a study published online May 8 in JAMA Network Open.
    • Rebecca K. Delaney, Ph.D., from the University of Utah Intermountain Health Department of Population Health Sciences in Salt Lake City, and colleagues explored the motivations of older adults in Colorado interested in purchasing edible cannabis products to improve sleep, pain, or mental health concerns, as well as the perceived benefits and drawbacks of different cannabinoid profiles. The analysis included 169 interview participants aged 60 years and older.
  • The New York Times relates,
    • “A study of insurance claims for 1.8 million children found that the number of families raising mental health issues at visits to general practitioners rose sharply over a decade, with anxiety by far the fastest-growing complaint.
    • “The study, which was published on Monday in the journal JAMA Network Open, found that the number of pediatric visits rose to 9.7 percent in 2023 from 5.7 percent in 2014.
    • “The study included all insurance claims for children from ages 1 to 18 in Massachusetts, for a total of more than 1.8 million children. Visits were counted as mental health visits if a diagnostic code was included in the claim, either because the child or the family raised the issue or because the child screened positive for mental health symptoms during the visit.
    • “Visits for anxiety rose by more than 250 percent during that period, to 6.1 percent in 2023 from 1.7 percent in 2014.”
  • The American Medical Association lets us know “nine things patients should know about taking creatine.”
    • “The ‘Health vs. Hype’ AMA podcast explores what creatine is, its association with bodybuilders, and whether it’s safe for the general public.”
  • Medpage Today tells us,
    • “A course of azithromycin for preschoolers who presented to the emergency department (ED) with wheezing didn’t improve their symptoms, the AZ-SWED trial showed.
    • :Among children, ages 18-59 months, the 5-day sum of scores on the Asthma Flare-up Diary for Young Children (ADYC) did not differ significantly compared with placebo in either those who initially tested positive for pathogenic bacteria (median 9.59 vs 9.72, P=0.70) or those who tested negative (9.30 vs 9.10, P=0.69). ADYC scores range from 5-35 points, with higher scores indicating more severe symptoms.
    • “While the trial was stopped early for futility — reducing the statistical power of the trial — it was sufficient to show that “a moderate or large true effect is implausible,” Richard M. Ruddy, MD, of the University of Cincinnati College of Medicine, reported at the American Thoracic Societyannual meeting in Orlando. The findings were published simultaneously in the New England Journal of Medicine.”
  • and
    • “The 2025/2026 seasonal COVID vaccination was associated with a roughly 50% reduced risk for illness up to 9 weeks post-vaccination, especially in older Canadian adults, according to an interim analysis by the Canadian Sentinel Practitioner Surveillance Network. The seasonal vaccine, which was specifically formulated to target the LP.8.1 variant, also appeared to offer protection from other strains.
    • “An important aspect of the 2025/2026 season was the simultaneous circulation of influenza and other respiratory viruses, which suggested the need to consider the role that respiratory virus co-circulation might play in estimating vaccine effectiveness (VE).
    • “This year, we were especially interested to check the effects of co-circulating respiratory viruses (eg, influenza and respiratory syncytial virus [RSV]) since COVID circulated at only low levels through the current season,” lead author Danuta M. Skowronski, MD, epidemiology lead for influenza and emerging respiratory pathogens at the BC Centre for Disease Control in Vancouver, told Medscape News Canada.”
  • The American Journal of Managed Care points out,
    • “A retrospective VA cohort (2006–2019) compared ≥75-year-olds with adenoma vs no adenoma at ages 65–75 using registry and National Death Index outcomes. 
    • “Ten-year CRC incidence and CRC death were statistically higher with prior adenoma, but absolute differences were small and clinically overshadowed by competing non-CRC mortality. 
    • “Frailty stratification showed progressively lower CRC incidence and sharply higher non-CRC death, with severe frailty demonstrating <1% CRC versus 82% non-CRC death. 
    • “Advanced adenoma status did not significantly alter CRC risk, and follow-up colonoscopy rates after 75 were not higher among patients later developing CRC. 
    • “Generalizability is limited by a 98% male veteran population, reinforcing the need for confirmatory analyses in cohorts with greater female representation.”
  • Per BioPharma Dive
    • “An experimental cancer immunotherapy from Regeneron failed a late-stage study in melanoma in a surprise setback for the big biotechnology company’s oncology business.
    • “A regimen involving the prospect, fianlimab, and Regeneron’s marketed medicine Libtayo didn’t significantly delay cancer progression compared to Merck & Co.’s Keytruda in patients with unresectable metastatic melanoma. A high-dose combination held tumors in check for a median of 11.5 months, compared to 6.4 months for Keytruda recipients, a difference that narrowly missed statistical significance.
    • “Regeneron didn’t provide additional details but will present them at a future medical meeting. Another Phase 3 study testing fianlimab against Opdualag, a similar cancer immunotherapy sold by Bristol Myers Squibb, is ongoing. Company shares fell by double digits early Monday, erasing billions of dollars in market value.”

From the U.S. healthcare business front

  • Kauffman Hall reports,
    • Key Takeaways
      • March was the best month for hospitals in 2026 so far, despite mixed volumes. Month-over month discharges rose while patient days fell, indicating increased focus on improving average length of stay and a continued shift to outpatient care.
      • Operating margins improved month-over-month but remain below 2025. While bad debt and charity care declined month-over-month, gross revenue continues to outpace net, highlighting eroding payor mix.
      • Expenses declined in March, yet remain elevated year-over-year. Favorable improvements across the board are likely correlated to the decrease in average length of stay. However, drug expenses remain a primary driver of expense growth year-to-date.
      • Two notable outliers emerged in otherwise steady regional trends. The Northeast saw margin improvement, despite historical underperformance, while the West experienced the most dramatic increase in drug expense.
    • To view more insights on trends affecting hospitals and steps you can consider taking to address them, download the latest issue of the National Hospital Flash Report.
  • Beckers Payer Issues notes,
    • “Blue Cross and Blue Shield of Massachusetts reported a net income of $59.6 million in the first quarter of 2026, a return to profitability after back-to-back annual losses in 2024 and 2025.
    • “The insurer posted revenue of $2.6 billion in the first quarter, reflecting a 2% net margin. Operating and other income came in at $17.4 million (0.6% operating margin), with investment income contributing $42.2 million.
    • “The company attributed the improved results to disciplined cost management, a milder-than-expected flu season and changes to its coverage of GLP-1 medications.
    • “Our first-quarter results reflect the challenging but necessary actions we’ve taken over the past year, including pricing our benefit plans to their true cost, identifying medical and pharmacy spending that doesn’t add value for our members, and keeping rate increases to our provider network at or below the state benchmark,” CFO Ruby Kam said May 15.”
  • Fierce Healthcare relates,
    • “Now three quarters into its fiscal year, Ascension has chopped down its operating losses by more than half and more than tripled its bottom-line gain. 
    • “The nonprofit system reported Friday a $203 million operating loss (-1.1% operating margin) for the nine months ended March 31, 2026, improving on the $466 million operating loss (-2.3%) for the prior fiscal year. 
    • “Both its total operating revenue and operating expenses dipped from the prior year due to a slew of divestitures. The former declined by 7.2% to $18.1 billion while the latter fell by 8.1% to $18.3 billion; on a same-facility basis, total operating revenue grew 9.3% while expenses increased 5.7%.” 
  • Healthcare IT News explains “How one practice combines in-clinic, telehealth and in-home care.”
    • “Dr. Payam Zamani is a practicing family medicine physician and founder and CEO of My Dr Now, one of the largest primary care providers in the Southwest. It’s designed as a hybrid in-person/telehealth/in-home health system.”
    • “When patients engage earlier and follow through consistently, the health system operates more efficiently, My Dr Now’s physician CEO reports: “This is not about technology for its own sake, it’s about designing care delivery around real life.”
  • Modern Healthcare tells us,
    • “Oregon gave the green light for Compassus to acquire a 50% stake in Providence’s home health and hospice operations across the state.
    • “After more than a year of review, Oregon Health Authority’s Health Care Market Oversight program said in a Friday news release it approved the joint venture with conditions.
    • “The Oregon deal is expected to close in the fall, Providence said in an email.”
  • and
    • “RWJBarnabas Health has opened a $7 million food-is-medicine hub to take on chronic disease, making it a potential standard bearer in the Make America Healthy Again movement.
    • “Last week, the New Jersey academic health system opened Harvest — an 8,000-square-foot facility in Newark that is a combination food bank, commercial kitchen and classroom. The center is designed to teach people living in nearby food deserts how to eat healthier and provide them with the food to do it.”
  • Health System CIO informs us,
    • “Epic added 77 acute care hospitals in 2025 while Oracle Health shed 56, according to the new KLAS report, “US Acute Care EHR Market Share 2026.” The five-year picture is even starker. Epic has gained a net 568 hospitals since 2021 while Oracle Health has lost 173. In total, the report covers EHR contracts executed from January through December 2025. Epic now holds 43.7% of acute care hospital market share and 56.9% of beds. Oracle Health, meanwhile, sits second at 21.9% of hospitals and 20.4% of beds, followed by Meditech at 14.7% and 12.5%.” * * *
    • “Hospitals impacted by EHR decisions fell about 40% from 2024 as buyers shifted investment toward AI and operational efficiency tools.”
  • Per MedTech Dive,
    • “Boston Scientific said Monday it has invested $1.5 billion to acquire a 34% equity stake in MiRus, a company developing a balloon-expandable transcatheter aortic valve replacement system.
    • “The agreement gives Boston Scientific an exclusive option to acquire the MiRus TAVR system, subject to additional payments and the completion of certain clinical and regulatory milestones. Boston Scientific said it may opt to acquire the rest of the TAVR business for additional cash payments totaling $3 billion.
    • “The deal comes about a year after Boston Scientific stopped selling its Acurate Neo2 and Acurate Prime TAVR devices, which were CE-marked in Europe, and ended plans to pursue approvals in the U.S. and other locations.”

Monday report

David Ermer–CDC, CMS, Electronic health records, FDA, Federal employment benefits, Medicare, No Surprises Act, OPM, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Per an HHS news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. visited Ohio this week as part of his “Take Back Your Health” tour. He met with the CEOs of the Cleveland Clinic, University Hospitals, and MetroHealth—three of the nation’s leading health systems—following a tour of the Cleveland Clinic. He also visited a Head Start program, a regenerative farm, and an addiction recovery facility, spoke at the City Club of Cleveland, and spent an afternoon at Summa Health. The tour highlighted the Secretary’s commitment to a prevention-first approach to healthcare as the pathway to Make America Healthy Again.
    • “Across Ohio, I saw communities move beyond symptom management and confront the root causes of disease head-on,” said Secretary Kennedy. “From visiting local programs to meeting with the CEOs of the Cleveland Clinic, University Hospitals, MetroHealth, and Summa Health, we are aligning leaders at every level around a prevention-first approach to reverse the chronic disease epidemic and deliver on President Trump’s mandate to Make America Healthy Again.”

  • FedSmith points out,
    • “In late 2025, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for Contract Year 2027, outlining significant changes to Medicare Advantage (Part C) and the Medicare prescription drug program (Part D).
    • “While many federal retirees rely on FEHB coverage, Medicare decisions—especially around Part B and Part D—remain one of the most important and misunderstood planning areas. This proposed rule signals where Medicare is heading next—and what federal retirees should be watching now.”
    • The article explains these changes.
  • Federal News Network reports,
    • “Despite some hiring occurring across agencies, overall employment in the federal government is continuing to decline. That’s according to the latest jobs report from the Bureau of Labor Statistics. BLS reported that in April, federal employment numbers decreased by another 9,000 jobs. Since peaking in October 2024, the federal sector’s numbers are now down by 11.5%, or 348,000 jobs.” 
  • STAT News relates,
    • “Two years ago, my old pal Rachel Cohrs Zhang and I reported how Medicare’s actuaries predicted the new Alzheimer’s drug Leqembi would cost the program $3.5 billion in 2025. It turns out that prediction was way off.
    • “Through the first three quarters of 2025, Medicare spent $139 million on Leqembi (made by Eisai and Biogen) and $74 million on Kisunla (a newer one made by Eli Lilly), federal data show. Together, that equals $213 million across 19,000 patients, and would be around $280 million for the entire year — a small fraction of the original estimate. Uptake for the drugs has been so muted that Medicare is not forecasting significant spending on them in 2026 or 2027.
    • “Predicting the myriad health care needs for a pool of 70 million older adults and people with disabilities is not an easy task. But neurologists and policy experts told me the lower-than-expected spending lines up with the challenges that have faced the Alzheimer’s drugs since their approvals: The intravenous medications are not easy to administer and require a lot of imaging; the population of patients who are eligible is limited; and the drugs continue to have little meaningful benefits while carrying a risk of severe side effects like brain bleeding.
    • Read Bob Hermans’ new story to learn more
  • and
    • “Changes to the no surprise billing law’s controversial arbitration process could come at any moment. Doctors and other providers are getting a lot more face time with the federal officials writing the regulations, my colleague Tara Bannow reports in a new story.
    • “Health insurers say providers are abusing the system by ramming through high volumes of ineligible cases. Providers claim insurers are not paying up when they lose and don’t give enough information. Ultimately, providers are winning more than 80% of cases, getting arbitration awards that are three to nine times the in-network rates. 
    • Read Tara’s story to find out the lobbying pitches from R1, Radiology Partners, the Blues, and employer groups.”

From the Food and Drug Administration front,

  • Beckers Hospital Review tells us,
    • “The fate of FDA Commissioner Marty Makary, MD, remained unclear May 11 after multiple news outlets reported May 8 that President Donald Trump had signed off on a plan to oust him — reports the president publicly waved off the same day.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced it is soliciting input on efforts with respect to drug repurposing to help address unmet medical needs across a range of diseases and conditions. 
    • “Identifying potential new uses—such as a new indication or a new population—for FDA-approved drugs can help accelerate the availability of treatments by using existing knowledge about the drugs, including a drug’s safety profile. This request for public input is part of a broader FDA initiative to update the labeling of FDA-approved drugs, when supported by sufficient evidence, to ensure that information in the labeling is clinically meaningful for health care providers and patients and scientifically up to date.”
  • MedPage Today informs us,
    • “The FDA on Friday [May 8] issued guidance for manufacturers collecting postmarketing data on the safety of approved drugs and biologics in pregnancy, with the goal of better understanding potential risks for the pregnant patient and fetus.
    • “Currently many medical products may be recommended to pregnant women by healthcare providers in spite of the fact that data from the clinical trials used for FDA approval were insufficient to assess safety during pregnancy,” Tracy Beth Hoeg, MD, PhD, the agency’s top drug regulator, said in a press release “This guidance provides specific recommendations about how postmarketing data can be leveraged and studies can be designed so clinicians and the public can be better informed about product safety and pregnancy-related risks can be more promptly identified.”
  • NBC News reports,
    • “The Food and Drug Administration removed the black box warning from hormone replacement therapies late last year, and recently, the most insured type, the estrogen patch, has been in short supply amid a boom in the therapy’s popularity.
    • “it’s unclear when supplies will rebound. Meanwhile, there are other options for hormone replacement therapy.”
  • Fierce Pharma lets us know,
    • “Argenx is poised to expand the reach of its generalized myasthenia gravis (gMG) treatment Vyvgart and subcutaneous Vyvgart Hytrulo with an expanded FDA nod that covers a wider pool of disease serotypes. 
    • “The label expansion now covers “all serotypes of adult patients living with gMG,” including anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive and triple seronegative gMG, argenx said. In the company’s phase 3 Adapt Seron study, the overall population of Vyvgart-treated patients experienced “rapid, significant and sustained improvements” in symptoms including speech, vision, physical function and other disease measures.” 
  • and
    • Roche’s intravenous-infused relapsing-remitting multiple sclerosis (RRMS) treatment Ocrevus scored a pediatric indication from the FDA, clearing the therapy for patients 10 and older and introducing a new treatment option to the underserved population. 
    • The agency based its approval on a clinical trial comparing Ocrevus to Novartis’ Gilenya (fingolimod), which was until now the only FDA-approved pediatric RRMS treatment. In the study, Ocrevus proved noninferiority to Gilenya in reducing patients’ annualized relapse rate and superiority in reducing new or enlarging T2 lesions and gadolinium-enhancing T2 lesions. 

From the public health and medical / Rx research front,

  • The Wall Street Journal shares what the Journal “knows about hantavirus drugs and vaccines in development.”
  • The New York Times reports,
    • “For about a decade, scientists have had remarkable success curing some blood cancers by modifying a patient’s own immune cells to recognize and kill the malignant cells.
    • “That same approach may help control H.I.V., among the wiliest of viruses, scientists will report on Tuesday. After a single infusion of immune cells engineered to recognize the virus, two people in a new study have suppressed their H.I.V. to undetectable levels, one of them for nearly two years.
    • “The data is scheduled to be presented at a gene therapy conferencein Boston, but the researchers shared an early copy with The New York Times.
    • “The treatment is years, if not decades, from being widely available, but the study offers what scientists call “proof of concept,” and the tantalizing hope that a single shot could one day offer lifelong relief from H.I.V.
    • “It is inspiration and a potential road map to get to where we need to go,” said Dr. Steve Deeks, an H.I.V. expert at the University of California, San Francisco, who led the trial.
    • “Other scientists were enthusiastic about the milestone.”
  • Radiology Business relates,
    • “Vigilance is needed to ensure patient safety in pediatric MR imaging, experts warn in new research published Friday by JACR. 
    • “Safety events remain relatively common in pediatric imaging, though most do not result in significant patient harm. However, these occurrences have the potential for serious consequences for patients, their parents or guardians, and MRI staff. 
    • ‘The conclusions are based on an analysis of safety data from five leading pediatric hospitals, spanning 2017 to 2022. Over the course of five years, there were about 146 pediatric MRI safety incidents that occurred, out of nearly 541,000 scans conducted. 
    • “Although uncommon, MRI safety incidents do occur in Zone IV of pediatric imaging departments,” corresponding author Jonathan R. Dillman MD, MSc, with the Department of Radiology at Cincinnati Children’s Hospital, and colleagues concluded. “While most cause no serious harm, their persistence and potential for catastrophic outcomes highlight the need for continued vigilance and ongoing safety improvements.”
    • “Zone 4 refers to the MRI scanner room, which presents the greatest risk of harm for both patients and staffers.” 
  • Med City News considers “Why We’re Still Finding Cancer Too Late>’
    • “The truth is there are ways to understand our cancer risk more precisely than we do today, and there are tools to manage it. What’s missing is awareness, access, and a system built to help us use these tools before something goes wrong.” * * *
    • “Healthcare innovators are shifting how we define and assess cancer risk, but education on evidence-based screening and risk-reduction practices needs to be front and center alongside these efforts so fewer people will ever have to say, “I wish I knew earlier.” Just like treatment options, prevention is not “one size fits all,” but a highly personalized approach. Individuals today can understand their risk of cancer far more clearly than any prior generation and, with the right information, resources, and support, can take powerful steps to reduce it. It won’t happen automatically. Our system is built to react to disease rather than anticipate it, which means personalized prevention rarely starts unless providers and patients help initiate it. 
    • “Instead of waiting for a cancer diagnosis, it’s time to ask the question: “What is this patient’s personal risk of cancer, and what can we do, starting now, to lower it and increase their chances of catching it early?”
  • A National Institutes of Health press release adds,
    • “Findings from a study supported in part by the National Institutes of Health (NIH) have identified a new model for predicting outcomes for hypertrophic cardiomyopathy (HCM), a heart condition with a prevalence of 1 in 500 people and a frequent cause of sudden cardiac death. Specifically, the findings demonstrate that incorporating prospective data including clinical history, imaging, and blood biomarker data into risk assessment can improve prediction of adverse cardiac events in people with HCM.
    • “The large, international study, called the Hypertrophic Cardiomyopathy Registry, was initially funded by NIH’s National Heart, Lung, and Blood Institute (NHLBI). The findings were published in JAMA.
    • “Current risk prediction guidelines for hypertrophic cardiomyopathy are imperfect, as they predict only sudden cardiac death, and not heart failure or other fatal and nonfatal cardiac adverse events,” said Christopher Kramer, M.D., a principal investigator of the study and cardiologist at the Heart and Vascular Center of the University of Virginia Health System. “This study is a major advance in that it provides evidence that incorporating these additional assessment methods better predicts risk of adverse outcomes.”
  • Health Day tells us,
    • “People hospitalized for opioid overdose have a higher rate of subsequent OD than previously thought, a new study says.
    • “Previously, it was estimated that about 6% of people who survived an opioid overdose wound up with a repeat overdose during the following year.
    • “But new results indicate that 21% experience a repeat OD after an emergency department visit for opioid overdose, researchers reported May 7 in the Journal of the American Medical Association.
    • “Patients’ risk of death also increased alongside their number of additional overdoses, the study found.
    • “Increased use of powerful synthetic opioids like fentanyl are fueling the rising risk of repeat overdose, researchers said.”
  • and
    • “Exposure therapy can successfully protect preschool children from peanut allergies, a new study says.
    • “Children ages 1 to 3 fed small amounts of peanut daily slowly became accustomed to them, researchers reported May 6 in The Lancet Regional Health Europe.
    • “All children who followed the protocol achieved the goal of eating three and a half peanuts without experiencing an allergic reaction, and most were able to consume up to 25 peanuts,” researcher Caroline Nilsson said in a news release. Nilsson is an associate professor of clinical science and education at the Karolinska Institute in Sweden.
    • “We consider the treatment to be safe if it is carried out under controlled conditions in a healthcare setting,” she said.”
  • MedPage Today points out,
    • “Human papillomavirus (HPV) vaccination rates varied substantially across and within U.S. regions, according to estimates in a retrospective, cross-sectional analysis, suggesting targeted interventions should focus on the needs of individual states.
    • “Comparing adolescents ages 13-17 years across the country against Alabama — where the 21% without at least one dose of the HPV vaccine approximates the national goal — several Northeast states did significantly better, including Rhode Island (adjusted OR 3.05, 95% CI 1.40-6.66), Massachusetts (aOR 2.19, 95% CI 1.24-3.88), and New Hampshire (aOR 1.72, 95% CI 1.03-2.88).
    • “Several Southern states significantly lagged Alabama in likelihood of HPV vaccination, including Mississippi (aOR 0.41, 95% CI 0.26-0.65), Georgia (aOR 0.45, 95% CI 0.27-0.76), Oklahoma (aOR 0.46, 95% CI 0.30-0.72), Kentucky (aOR 0.55, 95% CI 0.35-0.87), and West Virginia (aOR 0.56, 95% CI 0.36-0.87), reported Chinenye Lynette Ejezie, PhD, of Towson University in Maryland, and colleagues in a JAMA Pediatricsopens in a new tab or window research letter.”
  • Genetic Engineering and Biotechnology News informs us,
    • “For decades, physicians and scientists have thought that metformin, a biguanide drug that is prescribed for millions of people worldwide for type 2 diabetes (T2D), mainly targets the liver to suppress glucose production. A Northwestern University-led study in mice has now found that this “wonder drug” instead acts primarily on the gut, and prevents glucose levels from rising in the blood by driving glucose utilization inside cells lining the intestine.
    • “The research found that metformin slows mitochondrial energy production in gut cells by inhibiting mitochondrial complex I in the intestinal epithelium. This then “co-opts” the intestines to function as a glucose sink, forcing the intestine to metabolize extra sugar. The study also found that another biguanide drug, phenformin, and the structurally unrelated supplement berberine, which is known as “nature’s Ozempic,” appear to engage the same pathway in the gut as does metformin.
    • “The preclinical findings could help to explain several gut-related clinical effects in people who take metformin and suggest that modulating mitochondrial metabolism in the gut may represent an effective strategy for controlling blood sugar. “Metformin essentially helps the intestine suck the glucose out of the bloodstream, which further highlights that the gut plays a major role in regulating blood sugar levels,” said corresponding author Navdeep Chandel, PhD, professor of biochemistry and molecular genetics at Northwestern University Feinberg School of Medicine.”

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

  • Fierce Healthcare reports,
    • “Kaiser Permanente’s first-quarter operating performance took a step back in 2026 compared to the year prior, though investments and other sources of income picked up the slack to push the large integrated nonprofit’s bottom line past $2 billion. 
    • “The system reported operating income of $711 million for the quarter, or a 2.1% operating margin, in a Friday evening press release. It had logged $932 million in operating income, or a 2.9% operating margin, in the first three months of 2025.
    • “The organization’s performance came on the back of $34.6 billion in consolidated operating revenue, a roughly 8.7% year-over-year increase, and $33.9 billion of operating expenses, a 9.6% year-over-year increase.
    • “Though it grew in scale, Kaiser noted that it and its subsidiary Risant Health “continue to manage elevated costs in care delivery while taking steps to improve efficiency and maintain affordability.” 
  • and
    • “Omada Health reported revenue of $78 million in the first quarter, up 42% year over year as the company continues to expand its commercial reach and is seeing traction from its big investments in GLP-1 capabilities.
    • ‘The virtual chronic care provider reported strong adoption of its GLP-1 Care Track program while the company also continues to successfully sell multiple chronic condition programs to its existing customer base of employers and health plans, executives said during the company’s Q1 earnings call on Thursday.
    • “Q1 was the strongest first quarter in Omada’s history; on members, on revenue, on gross margin and on adjusted EBITDA,” Steven Cook, Omada Health’s chief financial officer, said during the earnings call. “Over the past year, we have been building capabilities to position Omada for durable growth, prescribing infrastructure, AI-empowered care delivery and an expanding set of GLP-1 and cardiometabolic solutions.”
  • Modern Healthcare relates,
    • “UnitedHealth Group Inc. said it will move away from having profits in its pharmacy benefits unit linked to the list prices of medications, the latest shift to address longstanding criticisms of its business model.
    • “Optum is UnitedHealth’s services arm. UnitedHealth’s Optum Rx unit helps determine which drugs are covered by health insurance plans, including UnitedHealthcare’s and others, and what prices patients must pay to access them. The company handled about 1.7 billion prescriptions last year.
    • “Optum Rx plans to shift to what a top executive called a more transparent fee structure that gives clients clarity into the money it gets from drugmakers. The way those details have been determined has been shrouded in secrecy, leading to claims that Optum Rx benefits from higher drug prices. The new approach is designed to refute those criticisms.” * * *
    • “We want our earnings based on service to the client,” Optum Chief Executive Officer Patrick Conway said in an interview. “We do not want any of those earnings tied to the list price of drugs, period.”
    • “The shift is expected to be complete by the end of next year, Conway said. It’s part of a series of changes the company is making to transform a business model that’s faced criticism from regulators, employers and lawmakers.”
  • The Wall Street Journal tells us,
    • “AstraZeneca is inching closer to its goal of reporting $80 billion in revenue by 2030 as the U.K. drugmaker pushes further into the U.S. and develops new oncology, rare disease and weight-loss drugs.
    • “The pharmaceutical giant has made progress on a pipeline of more than 25 medicines, each expected to generate more than $1 billion in revenue by the close of the decade, Chief Financial Officer Aradhana Sarin said. AstraZeneca hopes those drugs, along with new U.S. manufacturing investments and a direct listing of its shares in New York, will fuel growth.
    • “Revenue has been on the upswing since the company set its $80 billion target in 2024, with 2025 coming in at $58.74 billion. That was up from $45.81 billion in 2023, the year before it set the 2030 target.”
  • Beckers Health IT informs us,
    • “Whoop is rolling out new features to include virtual clinician visits and EHR integration.
    • The Boston-based fitness wearable company announced the updates May 8, positioning the new offerings as part of its broader shift from fitness and performance tracking toward clinical-grade health support, according to a Whoop news release.
    • “The new offerings include live, on-demand video consultations with licensed clinicians, which are expected to launch in the U.S. this summer. Whoop said the feature will allow members to connect with clinicians directly through the app, using months of biometric data, and when available, bloodwork and medical history, to provide a more comprehensive understanding of a member’s health.
    • “Whoop also announced plans to support electronic health record syncing through a partnership with HealthEx. The integration will allow members to access clinical information, including diagnoses, medications and procedures, directly within the app.”
  • Healthcare Dive notes,
    • “An influential group that advises Congress on Medicaid is recommending increasing transparency into artificial intelligence-backed prior authorization and boosting human oversight over automated pre-approvals for care. 
    • “The recommendations come as states and the federal government say they have limited insight into payers’ use of the technology in the safety-net insurance program, which can make it challenging for regulators to monitor for data bias or inaccuracies, analysts said during the meeting.”
  • Tech Target adds,
    • “The Workgroup for Electronic Data Interchange launched a free directory for organizations seeking testing partners for the CMS Advancing Interoperability and Improving Prior Authorization Final Rule (CMS-0057-F), in advance of the Jan. 1, 2027, compliance deadline. WEDI encouraged all organizations impacted by the rule to post their information on the directory and use it to test APIs with eligible partners.
    • “CMS-0057-F requires entities to implement certain HL7 FHIR APIs: Prior Authorization, Payer-to-Payer, Patient Access and Provider Access. The Prior Authorization API can identify documentation requirements for prior authorization approval, while the Payer-to-Payer API enables the exchange of claims and encounter data. The Patient Access API allows patients to access their health information, and the Provider Access API allows payers to share patient data with in-network providers.” * * *
    • “Organizations that want to test can complete a questionnaire that includes contact information, specific APIs available for testing and a link to their website. Organizations can also look for testing partners using the directory and contact the organizations they want to test with. The directory will display summaries of completed testing.
    • “At the time of publication, six entities had posted their information on the directory: Wellmark, Mayo Clinic, Veradigm, Blue Cross Blue Shield of Michigan, NextGen Healthcare and ZeOmega.”


Thursday report

David Ermer–CDC, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Federal News Network reports,
    • “The Postal Service is temporarily suspending payments to a governmentwide pension plan, after warning Congress that it’s less than a year away from running out of cash.
    • “USPS told the Office of Personnel Management on Thursday that it will hold off paying its contributions to the Federal Employees Retirement System (FERS), a move that’s expected to conserve cash in the near term.
    • “The mail agency, which has posted billion-dollar net losses almost every year since 2007, has relied on these extraordinary measures before to conserve cash.”
  • and
    • “The Postal Service received approval to add a temporary surcharge to most of its standard package shipping options. The Postal Regulatory Commission approved an 8% across-the-board price increase for its core package and shipping services. The surcharge will go into effect on April 26 and will remain in place until Jan. 17, 2027. USPS said the surcharge is necessary to keep up with higher fuel and transportation costs. Before this, USPS only added a package surcharge during its busy holiday peak season, which runs from October through December.”
  • OPM Director Scott Kupor explains how to chart your HR career path in his latest Secrets of OPM blog post which is available on Substack.
  • Tammy Flanagan writing in Govexec discusses “How to ensure your federal retirement benefit is correct.”
    • “OPM processed more than 33,000 retirement claims in early 2026. Learn how your FERS benefit is calculated and how to verify your creditable service.”
  • Federal News Network adds,
    • “More than 55,000 federal retirement applications are still pending finalization at the Office of Personnel Management. That’s after OPM managed to shave off about 10,000 applications from its total case inventory last month. During March, OPM received close to 15,000 incoming retirement applications, but processed over 22,000. Roughly half of those claims were completed digitally through OPM’s new processing system, which OPM said can finalize retirements at about double the speed as the traditional system.”

From the census front,

  • Per a U.S. Census Bureau news release,
    • “The nation turns 250 this year and Americans’ median age — the age at which half of the population is younger and half is older — continues to rise, climbing from 39.2 in 2024 to 39.4 in 2025.
    • “We use population estimates released today to examine changes in the U.S. age structure by sex from 2001, when the median age was 35.6, to 2025.
    • “One striking shift is that while women continued to outnumber men at older ages, the gap between the sexes narrowed in the past 25 years.
    • “In 2001, there were 70.6 males for every 100 females age 65 and older. By 2025, the ratio had increased substantially to 81.6.
    • “The gap among those age 80 and older narrowed even more dramatically — from 50.9 males per 100 females in 2001 to 68.3 in 2025.
    • “Mortality rates for older men have been decreasing faster than for women and, as a result, men’s share of the older population has increased,” said Marc Perry, senior demographer in the U.S. Census Bureau’s Population Division. “But the mortality gap between men and women is still there. In fact, the current mortality rate for men age 65 and older is roughly where the equivalent rate for women was 50 years ago.”
  • The Wall Street Journal reports,
    • “The nation’s fertility rates hit record lows in 2025 as childbearing continued to shift toward older women, according to new federal data released Thursday. For the sixth straight year, the number of children born in the U.S. remained at roughly 3.6 million.
    • “The number of births per 1,000 women ages 15 to 44—the general fertility rate—reached a record low of 53.1 in 2025, according to provisional data from the Centers for Disease Control and Prevention. The rate has mostly headed down since 2007, a prerecession peak when millennial women started to enter their prime childbearing years.
    • “One long-term trend driving the slide: a sharp decrease in birthrates for teens and women in their 20s. In 2025, birthrates for women in their late 30s exceeded those for women in their early 20s for the first time.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “Despite a mandate from the Trump administration to remove barriers for health artificial intelligence companies, the Food and Drug Administration has denied a proposal that would have made it easier for large developers of AI-enabled medical devices to put their products on the market.”
  • Modern Healthcare reports,
    • “The Food and Drug Administration has sent a warning letter to Medline Industries over reported issues with syringes used in cardiac procedures and the company could face regulatory action if the issues are not corrected.
    • “The company received the letter March 25 following a December inspection of its facility in Glen Falls, New York. The agency said the Namic angiographic control syringes, which are packaged into Medline’s cardiovascular procedure kits, were disconnecting from the hub that controls the flow of fluids. The letter was made public Tuesday.”
    • “In the warning letter, the agency said there were 221 complaints about the syringes and 177 medical device reports, including one involving air being injected into a patient and another exposing a clinician to a biohazard.”
  • MedTech Dive relates,
    • The Food and Drug Administration’s device center launched an innovation challenge Tuesday to give patients access to home medical devices to reduce hospital readmissions.
    • The Center for Devices and Radiological Health plans to select nine devices from different manufacturers by Dec. 4 for the challenge. Selected companies will have opportunities for early engagement with the FDA, including feedback to help refine device design and testing, and the chance to demonstrate their technology at FDA research facilities. 
    • The program, called the Reducing Readmissions through Device Innovation for the Home Innovation Challenge, is part of the device center’s Home as a Healthcare Hub initiative, which started in 2024. The initiative is intended to support innovation for medical devices used in the home, while considering diverse perspectives and people’s living environments.
  • and
    • “Philips sent an urgent field safety notice to customers in March instructing them to no longer use non-pneumatic nebulizers, including vibrating mesh nebulizers, with its Trilogy Evo ventilators.
    • “The Food and Drug Administration posted the action in its database last week as a Class I recall. It applies to Philips’ Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal and Trilogy EV300 ventilators.
    • “A Philips spokesperson wrote in an email to MedTech Dive that the ventilators may be used safely by following the revised instructions.”
  • Radiology Business tells us,
    • “Experts are sounding the alarm on a newly approved use of dermal filler in the décolleté area, citing concerns over its potential effect on breast cancer screening exams. 
    • “Radiesse, manufactured by Merz Aesthetics, is a subdermal filler used to smooth wrinkles and decrease the visibility of fine lines. The U.S. Food and Drug Administration on April 8 approved its use for the décolleté area—the upper chest above the breasts—in adults 22 and older. 
    • “The filler contains hydroxylapatite microspheres, which may be visible on medical imaging. Given the location of the implant and its close proximity to imaged area, experts are concerned it could affect the visibility of breast tissue on mammograms, masking small lesions. Experts voiced these concerns to the FDA during an advisory meeting about the product last August. 
    • “As a breast imager, my focus is to find a cancer as small as possible,” Sandra Shuffett, MD, of Baptist Health Medical Group in Lexington, Kentucky, explained during the panel. “That is my concern, with the fillers potentially obscuring a cancer on a mammogram until it grows larger and then requires more serious treatment.” 
    • “Merz Aesthetics has refuted these claims, maintaining the safety and efficacy of the product. As a precautionary measure, however, the FDA is requesting that the company conduct a postmarket assessment of 30 individuals to determine whether the filler affects breast imaging. The study will require participants receiving the injections to undergo baseline breast imaging before completing three filler treatments six weeks apart; they will complete additional breast imaging one month after all the treatments have been administered.” 

From the public health, medical and Rx research front,

  • Per an Epic news release,
    • “Epic Research now monitors health conditions across the U.S. at the county level and publishes Health Alerts when elevated rates are detected. The alerts use statistical models applied to real-world medical records to detect when the rate of a health condition in a county is higher than expected. Each alert is reviewed by the Epic Research team before it is published.
    • “You can view active Health Alerts here. You can also subscribe to receive Health Alerts by email. Subscribers receive new alert notifications when an elevated rate is first detected in a state and weekly summaries of all active, new, and resolved alerts.”
  • NBC News reports,
    • “Regular exercise and about seven hours of sleep a night could protect brain health in the long term, a study published Wednesday in the journal PLOS One found. Long bouts of sedentary behavior may increase dementia risk.
    • “It’s the latest data to show that people don’t need elaborate and expensive longevity hacks to stay mentally sharp as they age. Simple lifestyle changes could reduce a person’s risk of late-onset dementia by as much as 25%, according to the study. 
    • “About 1 in 9 people in the United States will develop Alzheimer’s disease, according to the Alzheimer’s Association, meaning a person’s overall risk is about 11%. With the suggested changes in lifestyle, the average person’s risk decreases to about 8%.
    • “The reduction is “fairly comparable to the effect sizes sometimes seen with medications for chronic diseases,” said Akinkunle Oye-Somefun, a researcher at York University in Toronto, who led the study. 
    • “Breaking up longer periods of sitting had the greatest effect, the study found.” 
  • MedPage Today adds,
    • “People who followed a high-quality plant-based diet had a lower risk of Alzheimer’s disease and other dementia, while those with a low-quality plant-based diet had a higher risk, prospective data showed.
    • “At baseline, people who ate the most plant foods overall had a 12% lower risk of dementia over nearly 11 years of follow-up compared with those who ate the least (HR 0.88, 95% CI 0.85-0.92), reported Song-Yi Park, PhD, of the University of Hawaii at Manoa in Honolulu, and co-authors.
    • “However, not all plant-based diets performed equally well. People with a high-quality plant-based diet at baseline had a lower dementia risk (HR 0.93, 95% CI 0.89-0.97), while those with a low-quality plant-based diet had a higher dementia risk (HR 1.06, 95% CI 1.01-1.10), Park and colleagues wrote in Neurology.”
  • BioPharma Dive relates,
    • “Invivyd said Thursday it has discovered and is preparing for human testing an antibody drug for measles, infections of which have spiked as of late in the U.S. due in part to rising vaccine hesitancy.  
    • “The Connecticut-based biotechnology company also provided an update for its lead program, an antibody for COVID-19 prevention, alongside its plans for the new drug’s development. Invivyd sees the antibody, known as VMS063, as a possible treatment for the disease or a preventive option for those who can’t, or won’t, get vaccinated. 
    • “VMS063 uses a similar strategy as approved antibody drugs for respiratory syncytial virus, which work by latching onto a surface “fusion” protein and blocking entry into cells. Invivyd said VMS063 could be the “first precision therapy” for measles and address the “immunity gap” emerging due to lower vaccination rates.” 
  • Health Day notes,
    • “In pediatric patients, influenza vaccine effectiveness (VE) varied across 2021 to 2024 seasons, but did help prevent influenza-associated hospitalizations and outpatient visits, according to a study published online April 6 in Pediatrics.” * * *
    • “Our study shows influenza VE ranged, but overall, was effective at preventing influenza-associated hospitalizations and outpatient visits in children aged 6 months to 17 years,” the authors write. “Higher pediatric influenza vaccine coverage could amplify the benefits of vaccination among children.”
  • Genetic Engineering and Biotechnology News tells us,
    • “The biological connection between a pregnant woman and her developing baby—the human maternal–fetal interface—is a specialized, transient organ composed of uterine cells from the mother and fetal cells that acts as a barrier, supports fetal growth, and maintains the mother’s health. The cellular complexity of the maternal-fetal interface has limited scientists’ ability to study how healthy pregnancies develop and why complications arise. The underlying cellular, molecular, and spatial programs of the interface—which forms about a week after fertilization and lasts until birth—has remain incompletely defined.
    • “Now, the human maternal–fetal interface has been mapped in unprecedented detail by scientists at the University of California, San Francisco (UCSF), revealing new cell types and providing insights into conditions such as preeclampsia, preterm birth, and miscarriage.
    • “By examining this tissue cell by cell across pregnancy, we can begin to understand both normal development and what may go wrong,” said Susan J. Fisher, PhD, professor of obstetrics, gynecology, and reproductive sciences at UCSF.”
  • Endocrinology Advisor notes,
    • “Elevated BMI in infancy and early childhood has a nearly null effect on pubertal timing. In contrast, high BMI in mid-childhood (starting around 6 years of age) and late childhood shows a strong, direct association with earlier onset.”

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

  • STAT News reports,
    • “At first blush, it might seem like Charleston, W.Va., New York, N.Y., and Janesville, Wis., have little in common. 
    • “But those three metros were flagged in a new report as having some of the country’s highest per-person health care spending. And there are other surprises, too. Three metros in California — a state known for its high prices — are among the lowest spenders, and two in West Virginia are among the highest. 
    • “The Health Care Cost Institute, a nonprofit, independent research group, released the report today along with a new data tool called Health Cost Landscape, which allows users to search for specific U.S. metro areas and examine the factors behind health spending there.  
    • “The tool and accompanying report rely on 1.3 billion medical claims from 2018 to 2022 from employer-sponsored health plans, representing more than 38 million people with employer sponsored insurance each year. 
    • “The fact that there’s not a consistent theme among the 10 highest and lowest spending metros speaks to the “irrationality” of health care spending in the U.S., said Katie Martin, HCCI’s CEO. Spending will always be a combination of price and utilization, but figuring out why each region landed on the list requires drilling down into its specific characteristics.” 
  • KKaufman Hall released its National Hospital Flash Report for February 2026.
    • “Key Takeaways
      • “Cost pressures are driving a tenuous financial outlook. Hospital expenses are elevated in early 2026 compared to 2025, while revenues are pressured by an eroding payer mix and remain below sustainable levels.
      • “Hospital performance is bifurcating. There is significant variation in hospital performance by size, geography, and market position.
      • “Softer, uneven volumes reflect shifting care patterns. Patient days have softened in early 2026 while the average length of stay remains relatively steady, reflecting both demographic shifts and changes in where care is delivered.
      • “Outpatient revenue is rising in early 2026. Outpatient care offers significant benefits to both patients and health systems, though hospitals must manage both revenue dilution and a greater concentration of high-acuity patients as a result.”
  • Kaufman Hall also posted its “M&A quarterly activity report: Q1 2026.”
    • “The Q1 2026 trends reflect an industry undergoing transformation. Health systems are repositioning by withdrawing from underperforming or non-core markets, building capital to invest in new capabilities, proactively seeking partners to increase resilience or enhance access to care and services, and placing big bets on new combinations of resources and capabilities. A return to more robust levels of deal-making is a sign that organizations remain well aware of the need to seek combinations and partnerships to face the challenges and opportunities that lie ahead.”
  • Fierce Healthcare tells us,
    • “Advocate Health notched a strong 2025 with more revenue, patients, operating income and bottom line gains than the year prior. 
    • “The nation’s third-largest nonprofit health system reported Wednesday over $38.9 billion in total revenue during the year ended Dec. 31, 2025, a nearly 12% increase over the year before. 
    • “Total expenses rose a hair slower, by about 11%, to $37.4 billion, leaving the organization with more than $1.5 billion in operating income (4.0% operating margin). It had reported a $1.2 billion operating income (3.5% operating margin) in 2024.” 
  • Beckers Hospital Review points out four hospitals that closed in the first quarter of 2026.
  • The Wall Street Journal reports,
    • “Eli Lilly’s Foundayo weight-loss pill is now available in the U.S. following the Food and Drug Administration’s approval.
    • “The drug is available through Eli Lilly’s direct sales platform, telehealth providers, and is shipping to retail pharmacies.
    • “Foundayo’s starting dose costs $149 a month, matching the price of Novo Nordisk’s competing GLP-1 pill.”
  • Beckers Hospital Review adds,
    • “Novo Nordisk’s recently approved high-dose Wegovy formulation has entered the U.S. market and is available for $399 per month for self-paying patients, the drugmaker said April 7. 
    • “In March, the FDA approved Wegovy HD, a 7.2-mg injection of semaglutide, as a weight loss medication. Prior to the approval, the highest dose of injectable Wegovy was 2.4 milligrams. 
    • “Wegovy HD’s launch comes days after the FDA approved Eli Lilly’s GLP-1 pill, Foundayo, which is the second FDA-approved GLP-1 pill for weight loss — the first is Novo Nordisk’s Wegovy pill. 
    • “Novo Nordisk’s direct-to-consumer platform offers self-paying patients to fill injectable Wegovy prescriptions for $199 per month’s supply of the 0.25-, 0.5-, 1-, 1.7- or 2.4-mg dosages. Wegovy HD is offered for $399 per month’s supply.” 
  • Per Fierce Healthcare,
    • “Humana is teaming up with digital health company b.well Connected Health to make it easier for members to access their health data across multiple providers, health plans, pharmacies and digital health apps. 
    • “The partnership aligns with a broader push by the Trump administration to give patients easier access to their health information.
    • “As part of the partnership with b.well, Humana will also be able to access its members’ data in real-time at the point of claims processing and securely respond to data requests from providers and other health plans, supporting care coordination and quality improvement, the insurer said in an April 9 press release.”
  • and
    • “Amazon is expanding its health conditions program with two recently announced partnerships focusing on nutrition therapy and sleep care. 
    • “The retail giant launched its Health Benefits Connector program in January 2024, which aims to help connect customers with virtual care benefits. Teladoc, Rula Health, Talkspace, Omada Health and Hinge Health are several of the organizations involved with the program.
    • “The most recent to join is virtual sleep clinic Dreem Health.
    • “Eligible customers can enroll in the care provider’s sleep services, which include sleep diagnostics using Sunrise Group’s FDA-approved home sleep test. Dreem Health will be the first sleep health provider on the platform, according to the April 9 announcement. 
    • “Artificial intelligence-driven nutrition therapy platform Berry Street also announced March 31 it would be joining Amazon’s program. The platform has a network of more than 1,500 registered dietitians providing nutrition therapy for weight loss, diabetes, cardiovascular disease and maternal health.”
  • MedTech Dive informs us,
    • “One year after President Donald Trump’s “Liberation Day” declaration in a White House Rose Garden ceremony unleashed a tariff policy targeting top U.S. trading partners, medtech companies are still absorbing the shocks.
    • “Tariffs on imports from China, Mexico, Canada, the European Union and other key trade partners were meant to boost domestic manufacturing, but in the medtech sector, where integrated global supply chainsdesigned for efficiency can take years to establish, reshoring has not been the primary response. That’s in contrast to the pharmaceutical industry and certain other sectors, where companies are pouring billions of dollars into building new production facilities in the U.S.
    • “To manage the extra expenses brought by tariffs, medtech companies have tried to avoid raising prices for hospitals and health systems or cutting R&D budgets, according to industry advisers and analysts. Instead, they are accelerating efforts to drive down costs across their organizations.
    • “They have to find levers elsewhere,” said Glenn Hunzinger, PwC’s U.S. health industries leader. “They’re not passing the prices on to customers. They’re just bearing the brunt of it and trying to find efficiency, which was always the focus.”

Tuesday report

David Ermer–CDC, Congress, Electronic health records, FDA, Generative AI, Medical / Rx research, NIH, No Surprises Act, OPM, U.S. Healthcare–

From Washington, DC,

  • Tomorrow, the House of Representatives will vote on the appropriations bill that funds the FEHB and PSHB, among other programs, H.R. 7006 – Financial Services and General Government and National Security, Department of State, and Related Programs Appropriations Act, 2026
  • Beckers Hospital Review tells us whether the ACA healthcare premium subsidies stand.
  • Fierce Healthcare adds,
    • “The Trump administration has released a new update on enrollment on the Affordable Care Act’s exchanges, with signups lagging notably behind figures for the 2025 plan year.
    • “Per the latest snapshot report, nearly 22.8 million people have signed up for coverage across the exchanges through Jan. 3. By comparison, 23.6 million people had enrolled in ACA plans through Jan. 4, 2025, according to a report from a year ago.
    • “Of that total, the Centers for Medicare & Medicaid Services said 2.8 million individuals are new enrollees, while nearly 20 million are returning customers. Close to 15.6 million people signed up for coverage through Healthcare.gov, and 7.2 million used a state-based exchange, according to the report.
  • Beckers Payer Issues provides us with eleven No Surprises Act updates.
  • BenefitsLink calls our attention to a November 2025 IRS notice that provides for inflation adjustments to qualifying payment amounts issued in 2026 under the No Surprises Act. According to BenefitsLink, the notice was not well publicized.
  • Milliman assesses “Medicare drug price negotiation: Navigating the next wave of maximum fair prices.”
  • BioPharma Dive adds,
    • AbbVie is the latest among more than a dozen of the world’s largest drugmakers to sign a drug pricing deal with the White House, announcing late Monday a deal to invest $100 billion in U.S. pharmaceutical research and manufacturing and lower some product costs in return for tariff relief. 
    • As with the many other deals revealed between the Trump administration and large pharma companies, the agreement is short on details as well as its potential impact on AbbVie’s earnings. AbbVie only said that it will provide “low prices” to Medicaid and boost efforts to sell through a government portal widely used medicines like Humira, Alphagan, Combigan and Synthroid — all of which are off-patent and face competition from lower-cost biosimilars or generics. 
  • Per an HHS news release,
    • The U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) today announced the appointment of two new members to the CDC Advisory Committee on Immunization Practices (ACIP). These appointments reflect the commitment of Secretary Robert F. Kennedy, Jr. to transparency, gold standard science, and diverse expertise in guiding the nation’s immunization policies. In June 2025, Secretary Kennedy reconstituted ACIP to restore public trust in vaccines.
    • The new members are Adam Urato, MD, and Kimberly Biss, MD.
  • MedPage Today offers backgrounds on the new members.
  • Federal News Network notes that “A sea of challenges opens up with 105,000 feds retiring.”
    • “The one-year drop in the number of GS-14s and GS-15s across government is causing some to be concerned about the future of federal management.”

From the Food and Drug Administration front,

  • MedTech Dive points out,
    • “Medtronic said Monday it received 510(k) clearance from the Food and Drug Administration for an app to connect its smart insulin pens with a glucose sensor made by Abbott.
    • “The app, called MiniMed Go, provides alerts for missed insulin doses, a dose calculator and guidance on what to do if a person misses a dose. It also includes software reporting for providers.
    • “The pairing is part of a partnership Medtronic struck in 2024 for Abbott to make an integrated continuous glucose monitor sold exclusively by Medtronic.”

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “The five-year survival rate for all cancers in the U.S. has reached 70% for the first time, according to a report published Jan. 13 by the American Cancer Society. The study analyzed diagnosed cases of cancer in the U.S. from 2015-2021. Among the findings, the study said that since the mid-1990s, there have been notable gains in the survival rates for more fatal cancers, such as myeloma (from 32% to 62%), liver (7% to 22%) and lung cancers (15% to 28%). The cancer mortality rate declined by a total of 34% since peaking in 1991, averting 4.8 million deaths since then.”
  • and
    • “A study released Jan. 12 by the Journal of the American College of Cardiology analyzed the current state of heart health in the U.S., highlighting the burden of disease, quality of care and mortality trends of risk factors and conditions that can lead to heart disease. The study found no change in the prevalence of hypertension among U.S. adults from 2009-2023 but found that hypertension-related cardiovascular deaths nearly doubled from 23 per 100,000 in 2000 to 43 per 100,000 in 2019. The prevalence of diabetes in U.S. adults increased from 11.9% in 2009-2010 to 14.1% in 2021-2023. Deaths related to type 2 diabetes increased from 30.4 per 100,000 adults in 2009 to 54 per 100,000 adults in 2023. The study analyzed other risk factors and conditions such as obesity, cigarette smoking and stroke, among others.”
  • STAT News adds,
    • “46% of U.S. counties don’t have a cardiologist. ARPA-H’s new agentic AI program could bring them specialized care.”
      • “The Agentic AI-Enabled Cardiovascular Care Transformation (ADVOCATE) program will support the development of Food and Drug Administration-authorized full-stack solutions that use agentic artificial intelligence to autonomously provide specialty care for every American living with advanced heart disease.”
  • The Washington Post explains how to know when to keep your kids out of school.
  • Per Genetic Engineering and BioTechnology News,
    • “Tahoe Therapeutics, Arc Institute, and Biohub have each made a multi-million dollar commitment to fill the massive data gap for virtual cell models. The teams exclusively told GEN Edge that more than 120 million single cell data points across 225,0000 perturbations will be generated using Tahoe’s Mosaic technology for mapping how drug molecules interact with biology.
    • “All three organizations lead a field that builds AI models trained on transcriptome data to predict how cell gene expression changes with cell states. In therapeutics, these virtual cells could gleam insight into new drugs capable of shifting cells from “diseased” to “healthy” with fewer off target effects.” 

From the J.P. Morgan Healthcare Conference,

  • Healthcare Dive reports
    • “JPM26: Dr. Oz, CMS leaders make their pitch to hospitals, payers on Trump admin healthcare policies.
  • and
    • “JPM26: CommonSpirit CEO teases new divestures, outlines AI wins and pitfalls”
  • Fierce Pharma offers a potpourri of biopharma stories from day 2.
  • STAT News adds,
    • It will be hard for OpenEvidence to top its 2025. The company announced nearly $500 million in funding last year and seemingly overnight became a go-to tool in the medical profession. A slide during the company’s Monday JPM presentation claims that queries to the company’s clinical evidence chatbot grew from 2.6 million in 2024 to 17.9 million in December 2025, with well over 100 million queries for the year.
    • “The company also revealed it will be launching “medical super-intelligence.” What does that mean? Katie Palmer explains in a new story.”

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

  • Beckers Hospital Review reports,
    • San Antonio-based University Health is investing $1.7 billion in a five-year expansion, including two new community hospitals and two multispecialty clinics.
  • and
    • “Skilled nursing facility operating capacity dropped by 5% in the U.S. between 2019 and 2024, according to a study published Jan. 12 in JAMA Internal Medicine.” 
  • STAT New relates,
    • “Illumina became a genomics juggernaut by developing machines that could read large amounts of DNA accurately and quickly. But the company’s betting the next phase of its growth will be accelerated by helping customers better understand genetic data and apply it to drug development.
    • “The San Diego firm took a step in that direction on Tuesday, when it unveiled what it says will be the world’s largest dataset of its kind, the Billion Cell Atlas. The atlas is based on the results of turning on or off genes across 200 cell lines, including lines used to study heart disease, neurologic disorders, immune conditions, and cancer.”
    • “Data on how these genetic perturbations affect cells could in principle help drug companies validate drug targets or create “virtual cells,” artificial intelligence-powered models of cell behavior. Thus far, Illumina has generated data from about 150 million cells and expects to reach a billion by the end of the year. The company’s already offering the atlas as a resource for pharmaceutical companies, with Merck, AstraZeneca, and Eli Lilly as its first customers. Several others have expressed interest, too, according to CEO Jacob Thaysen.”
  • Per MedCity News,
    • “If there’s any single company that understands or should understand the value of health data and its importance in patients’ lives, it’s Wisconsin-based EHR company Epic.
    • “And yet, while the company announced a whole host of future AI efforts last August, including a digital companion for patients called Emmie, it was OpenAI — which announced ChatGPT Health last week — that has actually given people the power to query their medical records and gain insights. Anthropic is announcing a similar capability for Pro and Max users of its Claude generative AI platform. Like Epic, other companies that demonstrated an understanding of that broad patient need also missed the boat.
    • “But in an interview on Friday, Epic’s chief medical officer pushed back on the notion that this was a “missed opportunity” for the EHR company.
    • “I would categorize it, instead of a missed opportunity, as thoughtfully developed over multiple years on top of other non-AI MyChart development and AI that’s actually going to be more thoughtful and tuned to your medical history and your personal medical care,” declared Dr. Jackie Gerhart, also a practicing family physician and vice president of clinical informatics.
    • “Gerhart, who has been with Epic for seven years, and another Epic R&D expert took some pains to describe how the company is developing the capabilities of Emmie, the digital concierge, deeply embedded within the EHR and able to not only handle simple queries like “create an exercise plan”or “explain my lab results” but also nudge you to do the things that you should do for better health.”

Midweek update

David Ermer–ACA, AHRQ, CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Medical / Rx research, Medicare, OPM, Patient safety, SDOH, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The Wall Street Journal reports
    • “The Senate plans two healthcare votes Thursday: one on a GOP bill that would put as much as $1,500 a year into health savings accounts in lieu of providing subsidies to cover premiums, and the second on a Democratic plan that extends ACA subsidies for three years. Neither is expected to reach the 60 votes needed to advance, but the willingness of some Republicans to consider any form of ACA extensions has opened the door to possible talks if the partisan measures fail.
    • “In the House, Speaker Mike Johnson (R., La.) said Republicans plan to put on the floor next week a package of healthcare proposals that doesn’t include extending subsidies. But other lawmakers see an ACA extension as the only way to prevent widespread pain ahead of the 2026 midterms and get a GOP-led Congress in position to make more sweeping changes.
    • “Rep. Jim Jordan (R., Ohio)—a onetime leader of the hard-line House Freedom Caucus—argued in a closed-door House Republican meeting that the party needed its own plan to temporarily extend the subsidies in tandem with more sweeping changes. If they didn’t, he warned, conservatives could be sidelined by centrists’ push to bring their own ACA extension to the floor.
    • “There’s a whole list of good things that we need to put in the legislation,” Jordan said in an interview. “But we also need to recognize reality, which is the cliff is coming in 21 days, and we have members who are very concerned about that. I think we all are.”
  • The Hill adds,
    • “The House on Wednesday easily passed the annual defense policy bill, sending the mammoth, $900 billion measure to the Senate ahead of the year-end deadline.
    • “The measure, known as the National Defense Authorization Act (NDAA), passed the lower chamber by a vote of 312-112. Ninety-four Democrats and 18 Republicans opposed the bill.
    • “The NDAA, a traditionally bipartisan bill that lays out defense priorities for the next year, would increase pay for service members, provide some military aid to Ukraine, restrict U.S. investment in China and fully repeal sanctions on Syria, among other things.”
  • Axios points out,
    • “Lab testing companies including giants Quest Diagnostics and LabCorp are pressing Congress to stop hundreds of millions of dollars of Medicare cuts for diagnostic tests that are due to take effect at the end of January.” * * *
    • “A 15% reduction to Medicare payments for nearly 800 lab tests is set to take effect Jan. 31, followed by additional cuts in following years.
    • “The change stems from 2014 legislation that aimed to align Medicare reimbursements for lab tests more closely with commercial payments.
    • “Medicare cuts that previously went into effect from the legislation cost labs nearly $4 billion over three years. Since then, the diagnostics industry has successfully argued the cuts are based on incomplete and outdated pricing information.” * * *
    • “Federal budget analysts previously used the Consumer Price Index as a proxy for lab payments. That measurement showed that delaying the changes appeared to save Medicare money. 
    • But the analysts have changed their model and now estimate that delaying the payment cuts will add to Medicare costs.”
  • Govexec tells us,
    • “The heads of the Office of Management and Budget and the Office of Personnel Management unveiled plans Wednesday to build a single information technology platform to manage all human capital data across the federal government. 
    • “In a joint memo, OMB Director Russ Vought and OPM Director Scott Kupor described a two-year plan to transition the federal government’s collection of disparate human resources networks onto a single system dubbed Federal HR 2.0.
    • “For too long, the Federal Government has lacked what is taken for granted at any other organization — a single system of record for personnel management. Instead, the Federal Government spends an inordinate amount each year on numerous costly, duplicative, and outdated core human capital management (“Core HCM”) systems,” the memo said. 
    • “As part of the plan, the memo said OMB and OPM officials will lead efforts “to procure a modern, best-in-class commercial Core HCM system” for governmentwide adoption by fiscal 2028.”
  • The Journal of Accountancy informs us,
    • “The IRS provided guidance Tuesday on new tax benefits for health savings accounts (HSAs) that include allowing bronze and catastrophic plans to be considered HSA-compatible under Sec. 223.
    • “The changes, which were part of H.R. 1, P.L. 119-21, commonly known as the One Big Beautiful Bill Act, generally expand the availability of HSAs under Sec. 223 and were outlined in Notice 2026-05.” * * *
    • “The IRS guidance also covered:
      • “Telehealth and remote care services: H.R. 1 made permanent the ability to receive telehealth and other remote care services before meeting the HDHP deductible while remaining eligible to contribute to an HSA, effective for plan years beginning on or after Jan. 1, 2025.
      • “Direct primary care (DPC) service arrangements: Beginning Jan. 1, 2026, an otherwise eligible individual enrolled in certain DPC service arrangements may contribute to an HSA. In addition, they may use their HSA funds tax-free to pay periodic DPC fees.”
    • “The IRS is seeking comments on Notice 2026-05 by March 6, 2026.”
  • Per Fierce Pharma,
    • “For more than two years, the U.S. Federal Trade Commission has been taking certain drugmakers to task over their alleged listing of “improper” patents in an FDA registry, a practice the agency says thwarts generic competition. 
    • “Now, after several prior wins with the effort, the agency is celebrating once again as Teva has agreed to remove more than 200 patents from FDA records, according to a Dec. 10 announcement.
    • “Following pressure from the FTC, Teva has asked the FDA to delist patents on certain products for asthma, diabetes, chronic obstructive pulmonary disease and for epinephrine autoinjectors, the FTC said. The removals from the FDA’s Orange Book registry will “pave the way for greater competition for generic alternatives” to more than 30 products, the agency explained.” * * *
    • “The AHA Board of Trustees has engaged WittKieffer to conduct a national search for Pollack’s successor as part of a planned transition. Pollack will remain fully engaged until the transition is complete.
    • “Recognizing Pollack’s commitment to the association, the AHA Board last month voted to bestow on him the title of AHA President and CEO Emeritus for when the transition is complete.”
  • The American Medical Association announced,
    • “AHA President and CEO Rick Pollack today announced his plans to retire by the end of 2026. A 43-year veteran of the association, Pollack has served as its chief executive for the past decade.
    • “Under Pollack’s leadership, the AHA steered hospitals through the COVID-19 pandemic, securing critical resources and regulatory flexibility to keep hospitals and health systems open and caring for patients during the most challenging public health crisis of recent time. Pollack launched bold initiatives to strengthen the health care workforce, advance quality and patient safety, and fortify cybersecurity defenses through partnerships with the FBI and other government agencies.
  • Per a Department of Justice news release,
    • “United States Attorney David Metcalf announced today that Recovery Centers of America (RCA) has agreed to pay $1,000,000 to resolve allegations that it failed to comply with provisions of the Controlled Substances Act (CSA) that are designed to prevent the diversion of controlled substances for illegal uses, and an additional $1,000,000 to resolve allegations that it violated the False Claims Act (FCA) by billing the government for drug and alcohol treatment services that it failed to adequately provide.
    • “The United States’ allegations under the CSA arise from audits and investigations the Drug Enforcement Administration (DEA) conducted at RCA facilities in Pennsylvania and Maryland between 2019 and 2024. Based on those audits and investigations, the United States contends that RCA dispensed controlled substances in an unlawful manner, that certain controlled substances were missing from the company’s records, and that the company failed to comply with additional recordkeeping requirements of the CSA.
    • “In addition, the United States alleges that, at certain facilities during a period from 2017 through 2019, RCA violated the FCA by billing the Federal Employees Health Benefits Program and Medicaid for the care of beneficiaries to whom it failed to provide and document the requisite treatment services.” * * *
    • “The resolution obtained in this matter was the result of a coordinated effort among the United States Attorney’s Office for the Eastern District of Pennsylvania, the DEA, the Office of Personnel Management Office of Inspector General, and the Department of Health and Human Services Office of Inspector General.
    • “The matter was handled in the U.S. Attorney’s Office for the Eastern District of Pennsylvania by Assistant U.S. Attorneys Peter Carr and Charlene Keller Fullmer and former auditor Dawn Wiggins.
    • “The claims resolved by the settlement are allegations only; there has been no determination of liability.“

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has cleared the first medicine under its new National Priority Voucher program, approving a U.S.-manufactured version of a decades-old antibiotic.
    • “GSK originally developed the drug, Augmentin XR, and won FDA approval for it in 2002. The British company then struck a deal in 2010 to sell its U.S. penicillin business, including its Augmentin franchise, to the generic drugmaker Dr. Reddy’s Laboratories. A Bristol, Tennessee, plant that was part of that deal is now operated by USAntibiotics, which won the priority voucher.
    • “FDA Commissioner Martin Makary trumpeted the approval as a boon for crucial supply chains of medications that often end up in shortages. The move “will strengthen domestic manufacturing and increase our national security,” Makary said in a statement Tuesday.”
  • Fierce Pharma adds
    • “The FDA has issued its stamp of approval to a new, cell-based option to treat Wiskott-Aldrich syndrome (WAS), marking the first therapy of its kind for the rare disease and making Italy’s Fondazione Telethon the first nonprofit to usher a gene therapy across the regulatory finish line in the U.S.
    • “Branded as Waskyra, the drug is specifically indicated for children 6 months and older, as well as adults who have a mutation in the WAS gene. To be eligible for the ex vivo gene therapy, patients must have no available human leukocyte antigen-matched related stem cell donor and be cleared for hematopoietic stem cell transplantation, the FDA said in its Dec. 9 announcement.
    • “Today’s approval is a transformative milestone for patients with Wiskott-Aldrich syndrome, offering the first FDA-approved gene therapy that uses the patient’s own genetically corrected hematopoietic stem cells to treat the disease,” director of the FDA’s Center for Biologics Evaluation and Research (CBER) Vinay Prasad, M.D., said in a release.”
  • and
    • “A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and labeling for those meds.
    • The document (PDF) finalizes a draft guidance issued by the agency in April 2024 and replaces a previous guidance on the topic that was initially published in 2020.
    • Differences from last year’s draft version are minimal, including only an addition in the introduction that its recommendations “apply regardless of the medium of the communication (e.g., paper, digital)” and a few extra lines about considerations for comparisons between biosimilars and their reference products, along with “editorial changes for consistency, readability, and clarity,” per the FDA.”
  • Per Beckers Health IT,
    • “The FDA has qualified the first AI-based drug development tool to support metabolic dysfunction-associated steatohepatitis clinical trials.
    • “The cloud-based tool, AI-Based Histologic Measurement of NASH (AIM-NASH), is designed to assist pathologists in assessing liver biopsy images, according to a Dec. 8 news release. It evaluates disease activity by scoring steatosis, hepatocellular ballooning, lobular inflammation and fibrosis according to the NASH Clinical Research Network scoring system.
    • “AIM-NASH uses AI to analyze digital images of liver tissue, but human pathologists remain responsible for interpreting the results. They review the entire slide and AIM-NASH output before accepting or rejecting the scores.”
  • BioPharma Dive notes,
    • “Vinay Prasad and two other officials within the Food and Drug Administration office regulating many genetic medicines have outlined a stricter approval framework for the next CAR-T cell therapies developed for cancer. In an article published Monday in the Journal of the American Medical Association, the trio wrote that newer CAR-T treatments need to extend survival, or the time before a type of event occurs, in randomized, controlled trials. The control groups in those studies must also take into account the existing standard treatments, including other approved CAR-T therapies, and prove superior unless “adequately justified and discussed” with the FDA. The new protocol represents a higher approval bar for CAR-T therapies, which, historically, have been cleared based on their ability to induce responses in single-arm studies.” 

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) today said the United States has 1,912 confirmed measles cases so far in 2025, an increase of 84 cases since last week and a bad sign as holiday gatherings, travel, and indoor activities is set to pick up in the final weeks of the year. 
    • “In January 2026, the United States is at risk of losing its measles elimination status because of ongoing transmission chains from a West Texas outbreak that began early last year and sickened roughly 800 people. The country first gained elimination status in 2000. 
    • “Eighty-eight percent of cases in the United States this year are outbreak-associated, and there have been 47 outbreaks recorded. Last year, 16 outbreaks were reported during 2024 and 69% of cases (198 of 285) were outbreak-associated.
    • “Currently Utah, Arizona, and South Carolina are seeing large outbreaks that since Thanksgiving have pushed state totals well past 100 cases. Those outbreaks have been marked by exposures at schools and churches in communities with low vaccination levels.”
  • STAT News relates,
    • “Federal health officials on Wednesday [December 10] expanded an outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since the company began production in March 2022.
    • “The U.S. Food and Drug Administration said investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever made.
    • ‘The outbreak now includes at least 51 infants in 19 states. The new case definition includes “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release,” according to the U.S. Centers for Disease Control and Prevention. The most recent illness was reported on Dec. 1.
    • “No deaths have been reported in the outbreak, which was announced Nov. 8.
    • “Previously, health officials had said the outbreak included 39 suspected or confirmed cases of infant botulism reported in 18 states since August. That’s when officials at California’s Infant Botulism Treatment and Prevention Program reported a rise in treatment of infants who had consumed ByHeart formula. With the expanded definition, the CDC identified 10 additional cases that occurred from December 2023 through July 2025.”
  • and
    • “While extensive studies have found Covid-19 vaccines to be safe, effective, and to have saved millions of lives during the pandemic, these shots come with a rare but real risk of inflamed heart muscle, or myocarditis. Scientists on Wednesday reported that they have identified a pair of immune signals they believe drive these cases — and offered early evidence that these signals can be blocked.
    • Researchers sifted through previous Covid vaccine studies and identified a pair of immune signaling molecules, or cytokines, present at higher levels in the blood of vaccine recipients with myocarditis: CXCL10 and interferon-gamma (IFN-γ). The authors found that these signals could also be triggered in the lab when immune cells were exposed to the Pfizer and Moderna Covid vaccines, or when mice were inoculated.
    • “Scientists found that using antibodies to block CXCL10 and IFN-γ reduced signs of cardiac stress in vaccinated mice and in cardiac spheroids, three-dimensional growths of human cells meant to mimic some aspects of the heart’s structure and function. The authors also found they could block the cytokines’ effects with genistein, a compound found in soybeans and other legumes that has been linkedto reduced inflammation.
    • “The findings, published in the journal Science Translational Medicine, come as messenger RNA vaccines face scrutiny from the Trump administration and some lawmakers. That has forced researchers studying these shots to strike a tricky balancing act between reporting new insights on adverse events while making clear that the shots are safe overall.
    • “I want to emphasize this is very, very rare. This study is purely to understand why. In those rare cases, what’s going on? People talk about it, and here we provide a mechanism,” said Joe Wu, director of Stanford Cardiovascular Institute and the study’s senior author.”
  • Medscape tells us,
    • “As women age, they face several health risks related to the menopause transition. Treating these risk factors, which include obesity and high blood pressure, can reduce the risks for diabetes, cardiovascular disease (CVD), and other health problems.
    • “These risks also can be driven by age-related changes that occur around the time of menopause, said Marie K. Christakis, MD, MPH, assistant professor of obstetrics and gynecology and menopause and mature women’s health at the University of Toronto in Toronto, during a presentation at the Diabetes Canada and Canadian Society of Endocrinology and Metabolism (CSEM) Professional Conference 2025.
    • “Women at midlife are in what I term a cardiovascular storm,” she said. “More than 42% of American women between ages 40 and 59 years have a BMI over 30, and the prevalence of obesity is higher among women between ages 40 and 59 years. Generally, menopause occurs naturally between ages 46 to 54 years, and central adiposity is a particular issue.” 
  • MedPage Today notes,
    • “In a large phase III trial of adjuvant treatment for early-stage breast cancer, the investigational oral drug giredestrant reduced the risk of invasive disease recurrence by 30% versus standard endocrine therapy.
    • “Among more than 4,000 patients with hormone receptor (HR)-positive disease, 3-year invasive disease-free survival (IDFS) rates reached 92.4% with the next-generation oral selective estrogen receptor antagonist and degrader (SERD), as compared with 89.6% with standard of care (HR 0.70, 95% CI 0.57-0.87, P=0.0014).”
    • “The findings of the lidERA Breast Cancer trial mark the first benefit with a novel endocrine agent in early breast cancer in 20 years, not since the approval of aromatase inhibitors (AIs) in the 2000s, said Aditya Bardia, MBBS, MPH, of the University of California Los Angeles.
    • “Overall, the results support giredestrant as a potential standard endocrine option for patients with hormone receptor-positive breast cancer,” said Bardia, who presented the findings here at the San Antonio Breast Cancer Symposium.”
  • Fierce Pharma adds,
    • “Pfizer has rolled out detailed trial data suggesting Tukysa could be part of a new first-line treatment to delay the progression of HER2-positive breast cancer.
    • “The current standard of care for the disease includes induction chemotherapy in combination with Roche’s Herceptin and Perjeta, followed by a chemo-free maintenance phase with the two HER2 antibody drugs. Now, Pfizer has shown that adding Tukysa during the maintenance stage can improve patient outcomes.
    • “Specifically, addition of Tukysa to first-line maintenance therapy significantly reduced the risk of progression or death by 35.9%, according to investigator-assessed results from the phase 3 HER2CLIMB-05 trial, which were presented at the San Antonio Breast Cancer Symposium. Patients who received the Pfizer small molecule went 8.6 months longer without tumor progression, reaching 24.9 months at the median.
  • and
    • “A year after a clutch of major pharmas threw their weight behind a new campaign devoted to addressing the serious health disparities facing Black breast cancer patients, “Care for HER” has been shown to have a tangible positive impact on patients’ lives.
    • “Touch, The Black Breast Cancer Alliance and Unite for HER—the two nonprofit organizations behind the program—presented a study about that impact at the San Antonio Breast Cancer Symposium on Wednesday.
    • “The research centers ran a survey of 57 participants in the Care of HER program, all Black women who have been diagnosed with breast cancer, 93% of whom said they’d used the program’s resources.”
  • Per Cardiovascular Business,
    • “Intravascular lithotripsy (IVL) is a viable treatment option for patients with diabetes undergoing percutaneous coronary intervention (PCI), according to new findings published in The American Journal of Cardiology.[1]
    • “While IVL has demonstrated favorable procedural and clinical outcomes in general populations with calcified lesions, its performance in patients with diabetes mellitus remains insufficiently characterized,” wrote senior author Jose M. Montero-Cabezas, MD, PhD, a cardiologist with Leiden University Medical Center in The Netherlands, and colleagues. “Given the unique anatomical and pathophysiological features of coronary artery disease in diabetic patients, such as medial calcification, longer lesion length, and more frequent multivessel disease, there is a clear need to specifically evaluate the efficacy and safety of IVL in this higher-risk population.”
    • “Montero-Cabezas et al. tracked data from nearly 600 patients who underwent PCI with IVL from May 2019 to September 2024. All data came from the BENELUX-IVL registry, an international database open to all IVL patients. Patients with missing data were excluded.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “CVS plans to launch a first-of-its-kind healthcare engagement platform, banking that perennial gripes about poor access and navigation will incentivize both consumers and rival companies to sign on.
    • “The platform will include data and services offered by CVS’ different health businesses — and those of participating industry partners. The goal is to create an integrated healthcare experience for consumers, hopefully enhancing their experience with the industry, lowering costs and improving outcomes, CVS executives said Tuesday during the healthcare giant’s investor day in Hartford, Connecticut. 
    • “CVS is also banking that the platform will also be a source of revenue by driving consumers to CVS products and services they might not know about otherwise.”
  • Kaufman Hall announced,
    • “Hospital volumes remained strong in October, while average length of stay declined, translating to a dip in net revenue per discharge. Bad debt and charity care continue to rise, and staffing levels are tightening.
    • “The recent issue of the National Hospital Flash Report covers these and other key performance metrics.”
  • The American Journal of Managed Care lets us know,
    • “As states and federal programs accelerate the shift to value-based care, a new national survey suggests clinicians face a widening gap between policy expectations and the tools available to meet them.
    • “Tracking patient progress emerged as the biggest barrier—more than insurance—for mental health and primary care clinicians adapting to outcome-based payment models, according to October 2025 survey findings released by Twofold Health, an artificial intelligence (AI) clinical notetaking platform.”
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of sibeprenlimab (Voyxact®, Otsuka Holdings Co., Ltd.), atacicept (Vera Therapeutics, Inc.), and delayed-release budesonide (“Nefecon”, Tarpeyo®, Calliditas Therapeutics AB) targeting abnormal complexes of immunoglobulin for IgA nephropathy.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.
    • “On December 17, as part of ICER’s Early Insights Webinar Series, ICER’s Chief Medical Officer, David Rind, MD, will present the initial findings of this draft report. This webinar is exclusively available to all users of the ICER Analytics platform; registration for the webinar is now open.
    • “The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on January 14, 2026.”
  • Per MedTech Dive,
    • “Teleflex has struck deals to sell its acute care, interventional urology and OEM businesses for a combined $2.03 billion, the company said Tuesday.
    • “Montagu and Kohlberg, two private equity firms, are buying the OEM business for $1.5 billion. Intersurgical, an anesthesia and respiratory care medtech company, is buying the acute care and interventional urology businesses for $530 million.
    • “Needham analysts said in a note to investors that the total sale price is at the low end of their estimates. Yet RBC Capital Markets analysts told investors they view the update positively.”
    • * * * “Selling the units will leave Teleflex focused on its vascular access, interventional and surgical businesses. The company picked the businesses as the focus of its ongoing operations because they serve attractive, primarily hospital-focused end markets. Teleflex framed the split as a way to simplify its operating model and manufacturing footprint.”

Friday Report

David Ermer–ACA, CDC, Congress, Electronic health records, FDA, Government Contracting, OPM, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “A dispute over a Trump administration plan to consolidate federal firefighting operations may be close to resolution, in a sign of modest progress toward Senate passage of a major fiscal 2026 spending package.
    • “Sen. Tim Sheehy, R-Mont., said Thursday he was prepared to release his hold on the Interior-Environment bill, a prime candidate for the “minibus” spending package, after cutting a deal to remove language that threatened to delay, if not derail, the firefighting reorganization.
    • “Sheehy, a former firefighting pilot and founder of an aerial firefighting and aerospace services company, is a key backer of the plan and rejected any effort to delay it.
    • “But we’ve cleared that language, so we should be good now,” he said.” * * *
    • “While Sheehy’s hold on the spending package may be lifted, Thune continued to negotiate with several other Republicans who have their own holds as they push for various causes, including a concern from some conservatives that spending levels are too high.
    • “Thune, R-S.D., told reporters Thursday that negotiators were still working “through the concerns that our members have,” but added he’s hopeful they “can land something soon.”
    • “A lot of conversations going on around that, but we just need to — we’ve got to get on the package of bills,” Thune said.
    • “Thune wants to add some combination of the Commerce-Justice-Science, Interior-Environment, Labor-HHS-Education and Transportation-HUD bills to the Defense bill in a package he could bring to the floor in coming days.”
  • Fierce Healthcare adds,
    • “As Congress continues to debate next steps on the Affordable Care Act’s enhanced subsidies, insurers are urging legislators to consider an extension with additional program integrity measures in place.
    • “AHIP said in a statement Wednesday that “common sense” steps to promote integrity can help mitigate the risks related to fraudulent enrollment in ACA plans or subsidies. The commentary comes after analysts at the Government Accountability Office were largely able to enroll in coverage and in the tax credits using fake profiles.
    • “GAO notes in the report that when the Centers for Medicare & Medicaid Services took steps to address fraudulent enrollments by improving identity verification and implementing three-way calls to stymie broker misbehavior, which have already had an impact on reducing unauthorized activity, AHIP said.
    • “With open enrollment underway and 24 million Americans facing the largest-ever spike in healthcare costs in 2026, Congress should take bipartisan action to preserve the health care tax credits and further strengthen program integrity,” AHIP said.”
  • The American Hospital Association News tells us,
    • “The Advisory Committee on Immunization Practices Dec. 5 recommended individual-based decision-making for parents deciding whether to give the hepatitis B vaccine, including the birth dose, to infants born to women who test negative for the virus. If not receiving the vaccine at birth, ACIP recommended infants receive the initial dose no earlier than 2 months of age. However, ACIP made no change to the existing Centers for Disease Control and Prevention recommendations to vaccinate infants born to women who test positive for the virus or have an unknown virus status. The recommendations also maintain consistency with all current health coverage options for payment, according to the Department of Health and Human Services. ACIP’s recommendations must be formally adopted by the director of the CDC before becoming part of the CDC immunization schedule.”
  • The Wall Street Journal explains what the ACIP recommendations means for readers.
    • “Under these recommendations, parents who wish to have their infants vaccinated at birth, if the mother isn’t infected with hepatitis B, will be able to do so after discussing it with their doctor. Doctors might face additional hurdles in administering the vaccine at birth for some families, including additional time spent counseling. 
    • “Insurers will likely still cover the shots if administered earlier than recommended. AHIP, a group representing insurers, said its members will cover vaccines recommended by ACIP through Sept. 1 until the end of 2026. Insurers typically handle coverage decisions yearly.”
  • Healthcare Dive lets us know,
    • “The HHS on Thursday released its plan to deploy and centralize artificial intelligence use within the agency, as part of a broader push by the Trump administration to cut costs and adopt the technology in the federal government.
    • “The agency said it will prioritize sharing AI resources among HHS departments, create a governance structure for new tools and promote use of the technology for public health initiatives.
    • “Although the strategy is internally focused to start, HHS said it will collaborate with the private sector and identify “priority” conditions and health issues that could be addressed with AI tools.” 
  • FedWeek calls to our attention a hiccup in the relatively new PSHBP Open Enrollment system that may require enrollee work arounds.

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a voluntary pilot designed to promote access to certain digital health devices while safeguarding patient safety.
    • “Developed by the FDA’s Center for Devices and Radiological Health (CDRH), the pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use to improve patient outcomes in cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.
    • “We are piloting an approach to encourage the use of digital technologies that meet people where they are,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This pilot supports innovative tools and a health care delivery model that could improve care for millions of Americans managing chronic disease.”
  • Per MedTech Dive,
    • “Advisers to the Food and Drug Administration on Wednesday voted 15-0 against use of Johnson & Johnson’s V-Wave shunt for heart failure patients not helped by medications.
    • “Members of the circulatory system devices panel were unanimously opposed to recommending approval of the implant based on effectiveness and its benefit-risk profile. On the question of safety, the panelists voted 9-6 in favor of the device.
    • “J&J is pursuing premarket approval for the heart shunt. Although advisory committees provide recommendations to the FDA, the agency makes the final decisions.
    • “Following the vote, a J&J spokesperson said the company is reviewing the FDA advisory panel’s recommendation for additional clinical evidence on the device.
    • “We will continue to work closely with the FDA, clinicians and other stakeholders to determine next steps,” the spokesperson wrote in an email.”

From the public health and medical/Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old. Seasonal influenza activity is increasing with the largest increase seen among children and young adults and in the northeastern and mountain west areas of the country. COVID-19 activity is low nationally.
    • “COVID-19
      • “COVID-19 activity is low nationally.
    • “Influenza
      • “Seasonal influenza activity is increasing with the largest increase seen among children and young adults and in the northeastern and mountain west areas of the country.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.
    • “RSV
      • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old.
    • “Vaccination
      • “It is not too late to get vaccinated ahead of the holidays. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The University of Minnesota’s CIDRAP adds
    • “Although this year’s flu season could be challenging, fewer adults have been vaccinated against influenza, a new study shows.
    • “Much less than half of US adults have been immunized against any respiratory virus, according to a survey of 1,015 adults released this week by the National Foundation for Infectious Diseases (NFID).
    • “Just 34% of adults have gotten a flu shot; 25% have had a COVID-19 shot; 8% have received a vaccine to prevent pneumococcal disease, caused by bacteria that can lead to pneumonia, meningitis, and sepsis; and 6% have been vaccinated against respiratory syncytial (RSV), a leading cause of hospitalization in infants and older adults.
    • “New data from IQVIA, which provides health care statistics, show similar declines over the past year. Retail pharmacies have seen falling numbers of vaccinations for three major respiratory viruses:
      • “34% decline in RSV vaccinations
      • “27% drop in COVID-19 vaccinations
      • “6% reduction in flu shots
    • “Pneumococcal vaccinations are the one bright spot in IQVIA’s data, with vaccinations rising 27% in the past year. The uptick is likely due to the Centers for Disease Control and Prevention’s (CDC’s) decision last year to lower the age at which people are eligible for pneumococcal vaccine from 65 to 50, said Robert Hopkins, NFID’s medical director.
  • Beckers Clinical Leadership tells us,
    • “Twelve percent of nearly 3,000 norovirus tests during the week ending Nov. 22 came back positive — a notable increase from the 6.82% positivity rate three months earlier, according to CDC data. 
    • “During the week ending Aug. 23, 6.82% of 4,034 norovirus tests were positive. A CDC system that tracks viral activity in the U.S. shows a 12% positivity rate among 2,825 norovirus tests, as of Nov. 22, the most recent data available.” 
  • Per Medscape,
    • “A newly cleared point-of-care test will enable rapid identification of whooping cough, according to a press release from manufacturer Roche.
    • “The molecular test uses the cobas liat system and earned an FDA clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for the detection of Bordetella infections, including pertussis.
    • “The CLIA waiver means that the test is approved for use in settings outside of a traditional lab, including a doctor’s office or pharmacy, and is considered sufficiently simple that it can be performed by healthcare personnel without extensive medical training.
    • “The test is currently available and provides polymerase chain reaction (PCR) results after approximately 15 minutes at the point of care, according to the company. Early symptoms of pertussis are similar to other respiratory illnesses, and a quick-turn test can confirm a diagnosis and facilitate timely treatment to prevent further spread of illness and protect patients from severe complications.”
  • and
    • “Current cardiac screening tools used to prevent myocardial infarction (MI) failed to identify nearly half of people who are at risk for MI, according to a new study. Those patients had low or borderline risk as per both standard and newer risk calculators for atherosclerotic cardiovascular disease (ASCVD). Most developed symptoms within 48 hours before the event, and many would not have been recommended statins or further testing if evaluated 2 days earlier.”
  • MedPage Today informs us,
    • “In a French cohort, the incidence of all-cause mortality among those who received a first dose of an mRNA COVID vaccine was 0.4% after a median follow-up of 45 months, compared with 0.6% of those who were unvaccinated.
    • “After standardizing characteristics between the two groups, all-cause mortality incidence was 25% lower in those who had received a COVID shot.
    • “Vaccinated people were 74% less likely to die in a hospital because of COVID-19 compared with those who weren’t vaccinated.”
  • and
    • “Three ancillary studies to the U.S. POINTER trial collectively demonstrated that a structured 2-year lifestyle intervention for older adults at increased risk of cognitive decline led to better overall health.
    • “In main results from the U.S. POINTER trial released in July, two lifestyle interventions — one structured, the other self-guided — improved cognitive scores in over 2,000 older adults, said Rema Raman, PhD, of the University of Southern California in Los Angeles, who co-chaired a symposium at the Clinical Trials on Alzheimer’s Disease (CTAD) annual meeting.
    • “Both 2-year interventions in U.S. POINTER encouraged physical activity, cognitive activity, healthy diet, social engagement, and cardiovascular health monitoring, but they differed in structure, intensity, and accountability.
  • Per Health Day,
    • “Your brain health might be linked to how well your kidneys are working, a new study says.
    • “People with impaired kidney function have higher levels of proteins in their blood that are linked to Alzheimer’s disease, researchers reported Dec. 4 in the journal Neurology.
    • “Our study found that when the kidneys are not functioning properly, there may be higher levels of Alzheimer’s biomarkers in the blood,” lead researcher Dr. Francesca Gasparini, a geriatrician with the Karolinska Institutet in Stockholm, Sweden, said in a news release.
    • “While we did not find that having reduced kidney function increased the risk of developing dementia, we did find that impaired kidney function may accelerate the onset of dementia in people who have higher levels of biomarkers.,” Gasparini said. “This highlights the need for doctors to consider kidney function when interpreting results of Alzheimer’s biomarkers in the blood.”
  • STAT News reports,
    • “Boehringer Ingelheim this week provided more details about a late stage clinical trial of an app designed to treat under-addressed symptoms of schizophrenia and revealed the company is preparing to submit the app to the Food and Drug Administration for clearance.
    • “Developed with Click Therapeutics, the app, CT-155, is a 16-week treatment that adapts key elements of established face-to-face psychosocial treatments for schizophrenia as an adjunct to antipsychotic drug treatment. Schizophrenia affects millions of people in the U.S. and is commonly associated with psychotic behavior and delusions. However, there are other common and often serious negative symptoms, including lack of motivation and the inability to experience pleasure, for which there are no approved drugs.”

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

  • Tech Target relates,
    • “Navigating an evolving regulatory landscape is top-of-mind for healthcare payers heading into 2026, with health plan executives saying changing requirements stemming from the Trump tax law has driven new priorities, according to a new HealthEdge report.
    • “The report, based on survey responses from 550 health plan executives in the United States, also flagged rising costs, better member engagement, investment in artificial intelligence (AI) and more collaborative payer-provider relationships as key priorities.”
  • McKinsey & Co. points out,
    • “Women in the United States face steeper barriers to healthcare than men, causing preventable suffering and costing billions each year. The health of women—encompassing the entire care continuum and extending beyond reproductive and sexual health—represents an approximately $50 billion missed annual opportunity for health systems nationally. Addressing the gap in women’s healthcare requires a fundamental transformation in care delivery, with preventive care playing a pivotal role to ensure accessibility, continuity, and comprehensive care.”
  • BioPharma Dive notes,
    • “Hemophilia gene therapies are struggling on the market, even as innovation soars. The business case for hemophilia gene therapy still isn’t adding up due to persistent market barriers.”
  • Per Fierce Healthcare,
    • “It’s been just over a year since Oura announced a partnership with Medicare Advantage insurer Essence Healthcare, and, now, the partners are looking to continue building on that foundation.
    • “The partnership initially launched for Essence’s PPO plan members, and, over the course of the year, grew into HMO plans as well. Saria Saccocio, M.D., chief medical officer for Essence, told Fierce Healthcare that a third of members who were eligible for an Oura ring chose to sign up, and two-thirds of that group was willing to share biometric data with the insurer.
    • “She said the effort began with sleep health and, over time, has shown members are improving their sleep scores. That’s translating to other areas as well, such as an increase in the amount of time engaging in light exercise.
    • “It’s that level of awareness and nudge that I think is helping improve the overall health of our members,” Saccocio said.”
  • and
    • “Wellvana has struck a 20-year affiliation with Mercy that will offer the system’s nonemployed primary care physicians and advanced practice providers participation in value-based care.
    • “The arrangement will give those independent clinicians access to Wellvana’s electronic-health-record-integrated practice tools and clinical and operational care teams, which the new partners say will reduce administrative burdens and help coordinate patient care.
    • “The providers’ participation in value-based arrangements will also bring financial incentives for better patient outcomes within Mercy’s service area and across Medicare, Medicare Advantage and commercial plans, they said. The organizations expect their clinically integrated network to be among the country’s largest.
    • “Mercy has built one of the nation’s most respected systems, and together we’re creating sustainable paths for independent providers to see the rewards of accountable care,” Wellvana CEO Susan Diamond said in Thursday’s announcement. “The more we grow participation in value-based care, the more patients and communities benefit from a better, more connected health experience.”
  • The Wall Street Journal offers readers six questions to ask their doctors before their doctors use AI to record their visits.

Tuesday report

David Ermer–CDC, CMS, Electronic health records, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • Federal News Network reports,
    • “Federal employees will be able to contribute more to their Thrift Savings Plan accounts next year. The IRS increased the maximum annual contribution limit to $24,500, which is a $1,000 increase over 2025. Additionally, employees aged 50 or older can save more money through their catch-up contributions. And if employees are aged 60 to 63, they can save even more with a higher catch-up contribution of $11,250. (IRS increases annual TSP savings limit for 2026 – IRS)”
  • The Wall Street Journal tells us,
    • “Calley Means, a confidant to health secretary Robert F. Kennedy Jr., is taking a permanent post in the Trump administration, where he is expected to serve as a bridge between the Make America Healthy Again movement and President Trump’s broader MAGA coalition.
    • “Means, who earlier this year served in a temporary role at the White House, has been tapped to be a senior adviser in Kennedy’s Department of Health and Human Services, charged with helping to ensure the success of the MAHA movement’s policy goals, according to people familiar with the matter.
    • “As of Tuesday, Means was listed in the department’s personnel directory—which is public—as a senior adviser in the office of Assistant Secretary for Health Brian Christine.”
  • Per an AHIP news release,
    • “Health plans contribute to the health and economic stability of communities throughout America. A new comprehensive report from AHIP offers a detailed state-by-state view of health coverage and underscores the indispensable role of health plans in communities nationwide. 
    • “Health plans support the health and well-being of Americans in all 50 states by delivering high-quality coverage and doing everything they can to shield consumers from the rising cost of care,” said Mike Tuffin, AHIP’s President and CEO.
  • The American Hospital Association News notes,
    • “The AHA and the Federation of American Hospitals Nov. 18 released a study conducted by Dobson | DaVanzo, underscoring the threat to patient care by expanding physician-owned hospitals in rural communities. The study found that if a new POH opens in the same market as a full-service rural hospital, the full-service hospital’s financial stability would be negatively affected as the POH would siphon off healthier and commercially insured patients, risking access to care and community jobs. 
    • “Full-service hospitals across the country are struggling, and rural hospitals are particularly vulnerable to headwinds. … Removing restrictions on POHs, which are notorious for selectively picking the healthiest and wealthiest patients and allowing them to open near full-service rural hospitals will jeopardize access to 24/7 care in rural America,” write Don May, FAH executive vice president of policy, and Ashley Thompson, AHA senior vice president of public policy analysis and development, in an accompanying blog.” 
  • The Centers for Medicare and Medicaid Services released today a new edition of the Section 111 user guide for group health plans, which term includes FEHB and PSHB plans.

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration has approved a new medication for a rare genetic condition in a decision that represents a long-awaited milestone for the drug’s developer, biotechnology company Arrowhead Pharmaceuticals. 
    • “The agency on Tuesday cleared the therapy, Redemplo, for familial chylomicronemia syndrome, or FCS, a rare condition that disrupts the body’s ability to break down fats in the bloodstream. It’s been specifically approved for use alongside a diet to help reduce levels of those fats, or triglycerides, in adults with FCS. The drug is self-administered via a subcutaneous injection once every three months.” 

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Health officials on Monday linked for the first time the measles outbreak that began in Texas with another in Utah and Arizona, a finding that could end America’s status as a nation that has eliminated measles.
    • “The news came in a phone call, a recording of which was obtained by The New York Times, among officials from the Centers for Disease Control and Prevention and state health departments.
    • “The chain of transmission began in January, in a conservative Mennonite group on the western edge of Texas and spread to Oklahoma and New Mexico.
    • “Countries lose their elimination status after 12 months of sustained transmission. If the outbreak cannot be extinguished by January, the anniversary of the first cases in Texas, the United States will lose what is known as “elimination status” as determined by the World Health Organization, which it has had for 25 years.”
  • Beckers Hospital Review informs us,
    • “Influenza activity remains low but is increasing across the U.S., according to the CDC’s latest FluView report. 
    • “The agency updated data on flu trends Nov. 14, offering the first national snapshot of respiratory virus activity since September. The update follows a nearly two-month blackout in national reporting, during which states had to pause dashboard updates or rely on internal data amid the federal government shutdown.
    • “Less than 1% of ED visits were flu-related, a figure that remained relatively stable compared to the previous week. However, flu-related ED visits are rising among children. The virus accounted for about 1% of visits among children 4 and younger, and 1.3% among those ages 5-17. 
    • “Nationally, 1,665 patients with laboratory-confirmed influenza were admitted to the hospital, up slightly from the previous week. Overall, flu activity remains low, with all states reporting “minimal” or “low” activity. 
  • NBC relates,
    • “While the average age for being diagnosed with heart disease in the United States is typically in the mid-60s for men and early 70s for women, the factors, such as high blood pressure, diabetes and bad cholesterol levels, can start years, sometimes decades, earlier. 
    • “A new online heart risk calculator could help younger adults learn whether they’re likely to develop heart disease, as much as 30 years in the future, according to a study published in the Journal of the American College of Cardiology on Monday. That’s a significantly longer time period compared with traditional screenings, including the Framingham risk calculator or the ASCVD Risk Estimator Plus, which measure a 10-year risk for people ages 40 and older. 
    • “This tool was motivated by helping younger adults understand their long-term risk for heart disease,” said senior study author Sadiya Khan, the Magerstadt professor of cardiovascular epidemiology at Northwestern University Feinberg School of Medicine. “We all procrastinate, but prioritizing health has to start today — and can with this tool.”
  • Per CNN Health,
    • “Starting prenatal care after the first trimester of pregnancy appears to be a growing yet dangerous trend in the United States, according to a new report.
    • “The report, released Monday by the infant and maternal health nonprofit March of Dimes, says that only about 75% of babies last year were born to mothers who started prenatal care in the first trimester of pregnancy.
    • “We’ve always known that getting that prenatal care started early is important,” said Dr. Michael Warren, March of Dimes’ chief medical and health officer. He added that now, in the United States, it’s moving in the “wrong direction.” * * *
    • “The new March of Dimes report gives the United States a D+ grade for having a preterm birth rate of 10.4% for the third year in a row.
    • “Sadly, I actually have to say that there was nothing that surprised us” in the new report, said Divya Sooryakumar, the vice president of programs and impact of the maternal health nonprofit Every Mother Counts, who was not involved in the report.”
  • BioPharma Dive points out,
    • “With new, positive data in hand, Merck & Co. plans to move its cardiovascular drug Winrevair into late-stage testing as a treatment for a condition often caused, at least in part, by high blood pressure.
    • “This condition — known as heart failure with preserved ejection fraction, or “HFpEF” — is common, affecting more than half of the roughly 6.7 million people in the U.S. believed to be living with heart failure. In these people, the heart’s main pumping chamber stiffens over time due to a variety of possible factors, including age, obesity and hypertension. While the chamber still pumps a “normal” amount of blood, patients with HFpEF can experience fatigue, shortness of breath, as well as life-threatening health complications.”
    • “The Food and Drug Administration has already approved several medicines for HFpEF, among them AstraZeneca’s Farxiga, Novartis’ Entresto, and Eli Lilly and Boehringer Ingelheim’s Jardiance. Merck has been trying to expand that list with Winrevair, a first-of-its-kind therapy that works by regulating signals from “activin” proteins that spur cell growth and division. In heart failure, the over-production of certain cells, molecules and proteins can harden the organ and impair its function.
    • “On Tuesday, Merck announced Winrevair had hit the main goal of a mid-stage clinical trial that enrolled 164 adults with high blood pressure in their pulmonary arteries caused by HFpEF.” 
  • and
    • “An experimental pill from Roche succeeded in a Phase 3 trial in early-stage breast cancer, helping prevent recurrence for longer than standard hormone therapies when administered after surgery in people with a common form of the disease.
    • “Roche didn’t provide specifics, but said that its drug, known as giredestrant, successfully extended disease-free survival compared to hormone therapy in people with ER-positive, HER2-negative breast cancer following surgical removal of a tumor. A “clear positive trend” was also observed on survival, though Roche said it’s too early to tell whether treatment clearly extended lives. 
    • “Giredestrant is part of a new class of oral “selective estrogen receptor degraders,” or SERDs, that aim to supplant a decades-old injectable therapy. So far, these drugs have largely only proven helpful for a particular subset of patients with advanced disease. Roche’s medicine is the first so far to show a benefit in the “adjuvant” setting, though others are also in late-stage testing.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Former Food and Drug Administration Commissioner Scott Gottlieb, M.D., is joining the board at industry giant UnitedHealth Group.
    • “The company announced the move Tuesday, with CEO and Board Chair Stephen Hemsley saying Gottlieb’s “exceptional healthcare career in both the public and private sectors” will bring valuable insight to the company.
    • “He is an innovator who constantly advocates for a more integrated healthcare approach supported by the latest technology,” Hemsley said. “We welcome his deep expertise and thought leadership as we strive to help people live healthier lives and make the health system work better for everyone.”
    • “Gottlieb served as the FDA Commissioner from 2017 to 2019, and during his tenure, he focused on transparency, patient safety and promoting competition. He took on the opioid epidemic and youth tobacco use during his time at the agency.”
  • Healthcare Dive adds,
    • “Optum Health, the care delivery arm of UnitedHealth, has tapped Krista Nelson as its new CEO effective immediately. Nelson announced the C-suite reshuffling via LinkedIn last week. 
    • “The executive has worked for UnitedHealthcare, UnitedHealth’s payer arm, off and on since 2009, according to her LinkedIn. Nelson was last responsible for overseeing the growth of government programs before switching over to UnitedHealth’s health services division Optum
      in May, when she was tapped as COO of Optum Health.
    • “Now, Nelson replaces Dr. Patrick Conway as the chief executive of Optum Health. Conway has been CEO of Optum since May and CEO of Optum Health since June.
    • “Conway will remain in his post as CEO of Optum following the reshuffling, according to his LinkedIn.”
  • Per Fierce Healthcare,
    • “Cigna Healthcare has unveiled Clearity, a new, copayment-only health plan designed to promote transparency and predictability.
    • “The new plan leans on Cigna’s in-house suite of artificial intelligence tools to make it easier for enrollees to make decisions for their care by arming them with critical information such as upfront pricing and verified patient reviews within a simple digital experience.
    • “The plan features a tiered copay model that does away with deductibles and coinsurance, Cigna said. Employers that select Clearity as an option can choose from five different packages with different cost-sharing options that don’t require narrowing networks or restricting access.
    • “Each package includes four in-network tiers and one out-of-network tier, according to the announcement.”
  • and
    • “Employers expect to see health benefits rise by 6.7% in 2026, reaching more than $18,500 per employee on average, according to a new report.
    • “Analysts at Mercer estimate that health costs in 2025 reached an average of $17,496 for each employee, growth of 6%. That’s a rate that outpaced inflation and wage growth, according to the report.
    • “The increase was driven by a sharp spike in prescription drug spending, which increased by 9.4% on average for large employers, or firms with at least 500 employees. Within that, large employers were more likely to cover GLP-1 drugs for weight loss this year, with 49% offering coverage compared to 44% in 2024.”
  • Per Fierce Pharma,
    • “Only days after revealing an unsolicited buyout bid from Lundbeck, Avadel—which has already signed an agreement to sell itself to Alkermes—has officially determined that the Lundbeck offer is sweeter.
    • “After “discussions and negotiations” with Lundbeck and separate consultations with its advisors, Avadel on Monday confirmed that it views the Lundbeck deal as a “superior company proposal.”
    • “The distinction is important because under Avadel’s existing transaction agreement with Alkermes, the latter company now has five business days to “discuss or negotiate in good faith” any potential amendments to its prior offer. Back in October, the companies got together on a $2.1 billion buyout agreement.
    • “Avadel says Lundbeck’s offer is worth up to $2.4 billion. The proposal features a $21-per-share upfront payment plus a contingent value right worth up to $2 per share based on future sales performance of Avadel’s narcolepsy drug Lumryz and pipeline candidate valiloxybate.”
  • Beckers Hospital Review lets us know,
    • “Novo Nordisk is temporarily offering doses of Type 2 diabetes drug Ozempic and weight loss medication Wegovy for $199, the drugmaker said Nov. 17. 
    • “Between Nov. 17 and March 31, self-paying patients of Wegovy or Ozempic can order their first two months’ worth of the medications for $199 per month, Novo Nordisk said. The discount applies to the two lowest doses, 0.25 and 0.5 milligrams, which are the recommended dosages for the first two months. 
    • “Following the first two months of treatment, self-paying patients will be eligible to order Wegovy or Ozempic for $349 per month. On Nov. 6, Novo Nordisk and the U.S. government reached a pricing agreement to sell Ozempic and Wegovy for $245 through Medicare and Medicaid, with a $50 copay for patients. The monthly prices will be $350 through TrumpRx, a direct-to-consumer website set to launch in early 2026. 
    • “GoodRx, Costco, WeightWatchers, CVS and other pharmaceutical retailers will participate in the offering.” 
  • The Wall Street Journal adds,
    • “The trillion-dollar club has become crowded with mostly tech names riding the AI boom. Eli Lilly LLY might soon join them for a far different reason: the weight-loss bonanza.
    • “Crucially, Lilly’s trajectory doesn’t hinge on artificial-intelligence sentiment or cloud-spending cycles that investors are suddenly questioning. In fact, it could even benefit from an investor rotation away from technology into other sectors. Its staying power above a $1 trillion market value will come down to two questions: how quickly it can expand the obesity-drug market and how completely it can dominate it. 
    • “On both fronts, its future looks promising. This year, Lilly has moved sharply ahead, securing Medicare access while widening its lead over Wegovy maker Novo Nordisk NOVO.B. That is why investors shouldn’t assume the rally stops at a trillion. 
    • “The key thing to remember is that—much like the AI boom—the GLP-1 surge is still in its infancy. Lilly only began selling its weight-loss drug Zepbound in late 2023, and the Food and Drug Administration only declared an end to a supply shortage of obesity drugs last year. As production has scaled up and new clinical data has emerged, Zepbound has pulled ahead of Wegovy. Despite Zepbound’s later launch, Lilly now captures a clear majority of new obesity-drug prescriptions, a sharp shift in market dynamics.”
  • Per Beckers Payer Issues,
    • “Medica plans to purchase certain contracts and assets from UCare as the latter’s legacy business winds down operations next year, the two companies said Nov. 17.
    • “We have the opportunity to build upon both Medica’s strengths and UCare’s legacy, allowing Minnesotans to continue to have a health care experience that ensures they feel cared for,” Medica CEO Lisa Erickson said.
    • “The agreement encompasses UCare’s Medicaid and ACA businesses that cover more than 300,000 Minnesotans. The transaction is expected to wrap during the first quarter of 2026. Individuals in UCare’s 2026 Medicaid and individual and family plans will still receive services without interruption.”
  • Per MedTech Dive,
    • “Medtronic’s pulsed field ablation business took off last quarter as competition in the space continues to heat up nearly two years after products first launched.
    • “PFA sales grew by more than 300% year over year in the U.S. and outside the U.S. in the second quarter of Medtronic’s fiscal 2026, according to materials released ahead of Tuesday’s earnings call. The company did not report specific sales figures.
    • “The technology fueled growth for the company’s overall cardiac ablation solutions business, or CAS, where sales increased by 71% year over year organically in the fiscal second quarter. Medtronic’s CAS business is steadily climbing as PFA adoption continues: The unit’s sales grew by nearly 50% and 30% in the company’s previous two fiscal quarters.”

From the artificial intelligence and electronic health records front,

  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a new $2 million Caregiver Artificial Intelligence Prize Competition to support the 1 in 4 Americans serving as caregivers for older adults and people with disabilities.
    • “This initiative through HHS’ Administration for Community Living (ACL) recognizes the millions of caregivers who support aging relatives and loved ones with disabilities. Their compassion and commitment form the backbone of America’s long-term care system, helping older adults and people with disabilities live with dignity and independence at home and in their communities.” * * *
    • “For updates on the competition, visit ACL’s Caregiver AI Prize Competition page.”
  • Fierce Healthcare reports,
    • “Aetna is rolling out a new artificial-intelligence-powered, conversational tool designed to make it easier for members to understand and navigate their health and benefits.
    • “The AI assistant is embedded in the insurer’s website and member app to readily answer questions that they may have about benefits and coverage, with session awareness that makes the experience feel less like a traditional chatbot. And members do not need to use healthcare jargon to secure answers, according to the company.
    • “For example, a member is told by their doctor that they need surgery. They can ask the assistant about their coverage for the procedure and receive a full and personalized breakdown of their costs and options, including estimates for fees and copayments.”
  • Healthcare Dive relates,
    • “Humana and Epic are partnering to speed patient appointment check-in and coverage verification for Medicare Advantage beneficiaries, the companies said Tuesday. 
    • “The new features are included in the electronic health record vendor’s payer platform, which allows insurance details from Humana to be automatically shared with providers before patients arrive at appointments, according to a press release. 
    • “The collaboration is an early result of an initiative from the Trump administration that aims to boost health data sharing and reduce repetitive, paper-based processes in healthcare, the companies said.” 
  • Beckers Health IT tells us,
    • “Oakland, Calif.-based Kaiser Permanente recently completed one of the largest EHR consolidations in healthcare history, migrating about 40 million patient records.
    • “In early 2025, the 40-hospital system merged 12 instances of its Epic EHR into two: in its Northern California and Southern California markets. In each case, the health system transferred roughly 20 million patient records with less than three hours of downtime and no canceled appointments or delayed procedures.”
    • The article also features a Beckers interview with “Neil Cowles, chief information and technology officer of Kaiser Permanente, to learn more.”

Midweek update

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Generative AI, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–

From Washington, DC,

  • Federal News Network reports,
    • “The Trump administration is calling on Congress to pass a four-month stopgap spending bill, in order to avoid a government shutdown, according to congressional appropriators.
    • “House Appropriations Committee Ranking Member Rosa DeLauro (D-Conn.) said in a statement Tuesday that the Trump administration is seeking a continuing resolution through Jan. 31, 2026.
    • “The administration is seeking a longer CR than some lawmakers previously considered. But the House and Senate aren’t close to getting 12 spending bills for fiscal 2026 through the normal appropriations process.”
  • The American Hospital Association adds,
    • “The House Appropriations Committee Sept. 9 advanced the fiscal year 2026 appropriations bill for the Departments of Labor, Health and Human Services, Education, and related agencies by a 35-28 vote. The bill provides a total discretionary allocation of $108 billion for HHS, representing roughly $7 billion or 6% below the FY 2025 enacted level. Within that total, the Health Resources and Services Administration was allocated $7.4 billion, marking an $880 million decrease. The agency was provided $1.3 billion for workforce initiatives, a $37 million decrease, and $515 million for rural health, marking a $150 million increase. 
    • “Additionally, the bill maintains funding for the Hospital Preparedness Program ($65 million), Children’s Hospitals Graduate Medical Education ($395 million), National Institutes of Health ($47 billion), as well as other key initiatives within the health care workforce, behavioral health and maternal and child health programs.”  
  • Roll Call informs us,
    • “Democrat James Walkinshaw won Tuesday’s special election for Virginia’s 11th District to fill the unexpired term of his former boss, the late Democratic Rep. Gerald E. Connolly.
    • “Walkinshaw, a Fairfax County supervisor, was leading Republican Stewart Whitson, an Army veteran and former FBI official, 75 percent to 25 percent, when The Associated Press called the race at 7:36 p.m. Eastern time. 
    • “Walkinshaw’s win was expected in the deep-blue Northern Virginia district, which encompasses the Washington, D.C., suburbs heavily populated by federal workers.” * * *
    • “Once Walkinshaw is sworn in, House Republicans will hold 219 seats to 213 for Democrats, with three vacancies that will be filled by upcoming special elections. 
    • “A special election in Arizona’s 7th District will take place later this month to elect a successor to the late Democratic Rep. Raúl M. Grijalva, who died in March from complications of his cancer treatment. There will also be special elections in Texas’ 18th District for the seat of the late Democratic Rep. Sylvester Turner and in Tennessee’s 7th District, where the Republican incumbent, Mark E. Green, resigned in July for a private sector job.”
  • The Wall Street Journal reports,
    • “U.S. population growth will slow to a crawl over the next few decades as fertility rates decline and net immigration shrinks because of stricter enforcement, the Congressional Budget Office said Wednesday. 
    • “Deaths are now projected to exceed births in 2031. Just eight months ago, CBO had projected that threshold wouldn’t be crossed until 2033.  
    • “By 2055, the U.S. population will be about 367 million, up from 350 million today. In January, CBO had projected a 2055 population of 372 million. From 1975 through 2024, U.S. population growth averaged 0.9% annually. By the early 2050s, according to the latest projections, population growth will effectively be zero.” 
  • Bloomberg Law tells us,
    • “The share of individuals in the US lacking health coverage held steady at 8%, or roughly 27 million people, in 2024, according to data the US Census Bureau released Tuesday.
    • “The data show fluctuations in the uninsured rate for different demographics, although the numbers were not considered statistically significant. Working-age Black Americans’ uninsured rate ticked up from 11.1% to 12.3%, while Hispanic Americans’ uninsured rate dipped from 23.6% to 23%. Foreign-born workers were more than twice as likely to lack health insurance as native-born workers.
    • “Coverage through public programs dropped 0.8 percentage points to 35.5%, driven by a 1.3 percentage point reduction in Medicaid enrollment. Medicaid coverage totaled 17.6% in 2024, while Medicare accounted for 19.1%.
    • “Private market coverage covered 66.1% of Americans, with 53.8% covered by their employer. Private coverage increased 0.7 percentage points, fueled by an increase in the individual market.
    • “The individual market covered 10.7% of Americans in 2024. Of that, the Affordable Care Act exchanges accounted for 4.3%.”
  • Modern Healthcare reports,
    • “A little over a month before the annual enrollment period, the Centers for Medicare and Medicaid Services is urging Medicare Advantage insurers to make significant changes to how they present their offerings to beneficiaries.
    • “Perhaps most notably, CMS will incorporate provider network lists into the Medicare Plan Finder tool enrollees use to select plans, it notified insurers last month. The agency is simultaneously developing a national provider directory that will not be ready in time for the 2026 Medicare Advantage and Part D sign-up campaign, which runs Oct. 15-Dec. 7.
    • “CMS also intends to add more details about Medicare Advantage supplemental benefits and a prescription drug pricing search tool powered by artificial intelligence.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA), and U.S. Customs and Border Protection (CBP) today announced the seizure of 4.7 million units of unauthorized e-cigarette products with an estimated retail value of $86.5 million – the largest-ever seizure of this kind. The seizures were part of a joint federal operation in Chicago to examine incoming shipments and prevent illegal e-cigarettes from entering the country.
    • “Almost all the illegal shipments uncovered by the operation originated in China. FDA and CBP personnel determined that many of these shipments contained vague and misleading product descriptions with incorrect values, in an apparent attempt to evade duties and the review of products for import safety concerns.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “The FDA is planning to call on the health-care industry and consumers to provide information on the benefits of switching a prescription drug to over-the-counter, the agency’s drug chief said Tuesday.
    • “What we want people to do is focus on the benefit that we can provide to society by that switch,” George Tidmarsh, director of the Center for Drug Evaluation and Research, said at a regulatory conference held by the Consumer Healthcare Products Association.
    • “I encourage industry to really focus, in the broadest way, on the benefit of the switch,” Tidmarsh added. “Not just the specifics of that, but the impact broadly in the health-care system.” 
    • “The agency will announce the request for information in the Federal Register, the drug chief said.
    • “Switching a prescription drug to over-the-counter is a highly regulated process that widens the range of medicines available to consumers.”
  • Per the AHA News,
    • “The Food and Drug Administration Sept. 10 released draft guidance on non-opioid treatments for treating chronic pain and reducing prescription opioid misuse. The guidance includes regulatory considerations regarding the categorization of multiple chronic pain conditions versus individual chronic pain indications; the design of clinical trials that ensure safety and efficacy; the evaluation of non-opioid drugs to avoid, reduce or eliminate opioid use; and the inclusion of statistical principles, patient-reported outcomes and use of expedited programs to support non-opioid drug development. The FDA is accepting comments on the guidance for 60 days following publication in the Federal Register.”
  • BioPharma Dive lets us know,
    • “The Food and Drug Administration on Tuesday approved a drug-device combination for bladder cancer that its developer, Johnson & Johnson, claims represents “a new, potentially practice-changing approach.”
    • “The treatment, which J&J will sell as Inlexzo, is a medical device that releases the chemotherapy gemcitabine into the bladder. It’s approved for use in people whose disease hasn’t yet spread but doesn’t respond or stopped responding to a commonly used immunotherapy. Historically, those patients have had have their bladders surgically removed.
    • “J&J executives have predicted Inlexzo will achieve blockbuster sales, and highlighted how the company’s internal sales estimates are more than three times higher than Wall Street’s predictions. “We really think that we’ve got a winner there,” Jennifer Taubert, the head of the company’s pharmaceuticals business, said on a conference call in July.”
  • Genetic Engineering and Biotechnology News adds,
    • “There are multiple different types of drugs available for the treatment of Alzheimer’s disease: cholinesterase inhibitors to treat symptoms from mild to severe, and disease-modifying immunotherapies to remove amyloid plaques and slow disease progression. In addition, vaccines that aim to clear the amyloid-beta plaques that accumulate in the brains of Alzheimer’s patients—or the neurofibrillary tangles formed by abnormal tau proteins—have been an area of active study.
    • “Now, a vaccine moves one step closer to approval. The Swedish biopharmaceutical company Alzinova recently announced that the FDA has approved the company’s Investigational New Drug (IND) application for its planned Phase II clinical study with the vaccine candidate ALZ-101 for Alzheimer’s disease. The company’s clinical development specializes in the treatment of Alzheimer’s disease, at the starting point of attacking toxic amyloid-beta oligomers.” * * *
    • “ALZ-101, a vaccine that stimulates the production of antibodies against the toxic Aβ oligomers, is Alzinova’s lead candidate. The company ran a first-in-human clinical study to evaluate the safety and immunogenicity of the oligomer-specific therapeutic vaccine ALZ-101 and released favorable data from part A of its Phase Ib clinical trial in November 2023.”

From the public health and medical/Rx research front,

  • ABC News reports,
    • “The United States death rate decreased by 3.8% in 2024 as COVID fell out of the top 10 leading causes of death for the first time in four years, new provisional federal data shows.
    • “The overall rate declined from 750.5 per 100,000 people in 2023 to 722 per 100,000, according to the report from the Centers for Disease Control and Prevention’s National Center for Health Statistics (NCHS).
    • “This marks the lowest death rate recorded since 2020, during the first full year of the COVID-19 pandemic and follows declines that began in 2022.
    • “The report also found that overall deaths fell from 3.09 million in 2023 to 3.07 million in 2024.
    • “Additionally, the report showed the three leading causes of death stayed the same from 2023 to 2024, with heart disease as the leading cause, followed by cancer and unintentional injury, respectively.
    • “‘It’s pretty noteworthy that COVID-19 fell off the top 10 and suicide, which had been had fallen off in recent years, is … ranked again,” Farida Ahmad, corresponding author of the report and health scientist at NCHS, told ABC News. “I think that’s a pretty interesting finding given where we spent the last five years.”
    • “Ahmad said fewer deaths from COVID in 2024 compared to 2023 may be a reason behind the 3.8% decline.”
  • STAT News points out,
    • “Many Americans take a dark view of nicotine. The stimulant, which occurs naturally in tobacco plants, is what makes cigarettes so addictive, with smoking responsible for 490,000 American deaths each year. When people try to quit smoking, it’s often cravings for nicotine, and the surge of dopamine it releases in the brain, that foil their attempts.
    • “In this sense, nicotine is responsible for many health problems. But public health experts say that while nicotine poses risks, some nicotine products are safer than cigarettes — and they worry popular misconceptions about the chemical’s effect on the body are doing more harm than good. 
    • “A majority of people in the U.S. wrongly believe that nicotine is the substance in cigarettes that causes cancer. In fact, “the harm from smoking comes from the burning of the ingredients in a cigarette, not from the nicotine itself,” said Jamie Hartmann-Boyce, a health policy researcher at the University of Massachusetts Amherst. More than 70 carcinogens have been identified in the cigarette smoke produced by the combustion of tobacco, which can damage people’s DNA and lay the groundwork for cancer.
    • “For many years, cigarettes were the main way that most Americans consumed nicotine. That meant it wasn’t a big problem from a public health perspective if people conflated the dangers of smoking with the dangers of that particular chemical, so long as that helped deter them from lighting up.
    • “Now, thanks to the more recent introductions of smoke-free options like e-cigarettes and nicotine pouches, “we are in a totally different landscape when it comes to commercial nicotine products,” Hartmann-Boyce said.”
  • The University of Minnesota’s CIDRAP notes,
    • “One more measles case has been reported in Wisconsin’s Oconto County measles outbreak. The new case raises the state’s total to 25. All 25 cases have been in unvaccinated individuals, and 2 people have required hospitalization.  
    • “The Centers for Disease Control and Prevention (CDC) has posted its weekly measles update, and 23 more cases have been recorded since last week, raising the national total to 1,454. There are two more outbreaks, raising the total number of outbreaks to 37. Eighty-six percent of cases reported this year are linked to outbreaks.”
  • and
    • “A new survey of more than 21,000 US adults shows that those who reported food insecurity had a 73% higher chance of reporting post–COVID-19 condition, or long COVID. 
    • “The study was published yesterday in JAMA Network Open and adds to a growing body of literature that links food insecurity with delayed or forgone medical care, worsened mental health, and racial disparities during the COVID-19 pandemic, the authors said. This is the first known study to link food insecurity to long COVID.”
  • Per MedPage Today,
    • “The American Academy of Family Physicians (AAFP) split with federal health officials and recommended that all U.S. adults get an updated COVID-19 vaccine for the upcoming respiratory virus season.
    • “In particular, people 65 years or older, those at increased risk for severe outcomes, and anyone who has never received a COVID-19 shot before should be prioritized for vaccination, AAFP said.
    • “The move follows recent recommendations from the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG), which broke with federal COVID-19 vaccine guidance for children and pregnant women.”
    • “History shows us that vaccines have eradicated diseases that were disabling and deadly in the past, and we can keep it that way, if we continue to vaccinate,” Margot Savoy, MD, the AAFP’s chief medical officer, said in a statement. “AAFP’s recommendations are closely aligned with other medical societies to ensure continuity for both patients and physicians.”
    • :Like the recent AAP guidance, AAFP says that all children ages 6 to 23 months should be vaccinated against COVID-19. For children and teens ages 2 to 18 years, clinicians should use a risk-based, single-dose approach, according to the new recommendations. The AAFP said it supports immunization access for any family wanting COVID-19 vaccination.
    • The AAFP also recommends that women who are pregnant at any stage or lactating should get a COVID-19 shot, in line with ACOG’s recent recommendations.
  • The Washington Post reports,
    • Persistent sleeplessness may be far worse than a passing annoyance — gradually unraveling memory and mental sharpness, according to new research.
    • A study published Wednesday in Neurology, the journal of the American Academy of Neurology, identifies a troubling link: Older people who have chronic insomnia appear more likely to experience accelerated aging of the brain. These changes are revealed in both cognitive tests and imaging scans showing the altered structure of the brain.
    • The research involved 2,750 cognitively healthy adults with an average age of 70. The participants, who were tracked on average for 5.6 years, underwent annual testing of executive functioning, visual-spatial reasoning and other dimensions of cognition.
  • Per Beckers Hospital Review,
    • “A study found that GLP-1 drugs are associated with a lower risk of fractures, including hip and osteoporotic fractures. 
    • “The research, led by scientists from China and published in Acta Diabetologica, analyzed more than 490,000 adverse event reports from the FDA’s Adverse Event Reporting System between 2004 and 2022. Of the reports, 99,000 involved GLP-1 receptor agonists. 
    • “The study found that compared to other diabetes medications, GLP-1 receptor agonists had the lowest reporting odds ratio of any fracture-related adverse events, at 0.44. 
    • “The trend surfaced across fracture types, including osteoporotic and hip fractures. Among individual GLP-1 receptor agonist drugs, albiglutide showed the most pronounced reduction in fracture risk, researchers said.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “U.S. businesses are facing the biggest health-insurance cost increases in at least 15 years, after already-steep boosts in recent years that have pushed the annual expense for family coverage high enough to equal the price of a small car.
    • “Costs for employer coverage are expected to surge about 9.5% in 2026, according to an estimate from Aon, while an employer survey by WTW suggested 9.2%. Both benefits-consulting firms’ projections, which were provided exclusively to The Wall Street Journal, would represent the fastest rate of increase since at least 2011, when the price tags for employer coverage were far lower than the recent average of roughly $25,500 for a family plan.
    • “Other employer surveys conducted this year have generated similar findings—sharp hikes in health-coverage spending for next year, on top of two years of significant increases.”
  • Modern Healthcare reports,
    • “Kaiser Permanente and Renown Health signed an agreement to form a joint venture to operate a health plan and ambulatory care services in Nevada. 
    • “As part of the deal, Kaiser would acquire a majority stake in Renown’s insurance arm, Hometown Health, which has more than 73,000 members. Kaiser plans to start offering health plan coverage in northern Nevada as Kaiser Permanente Nevada with an open enrollment period late next year, according to a Wednesday news release.
    • “Kaiser Permanente Nevada would also open ambulatory sites with Renown in the Reno, Nevada, area. 
    • “The deal is expected to close in early 2026, pending regulatory approval.
    • “If approved, the joint venture would mark Oakland, California-based Kaiser’s expansion into Nevada. Kaiser already has more than 12.6 million health plan members in eight states and Washington, D.C.”
  • and
    • “Dr. Craig Albanese, CEO of Duke University Health System, will step down from his role to become president of integrated care and coverage for Kaiser Permanente effective Sept. 29.”
  • STAT News tells us,
    • Lilly “has signed a collaboration agreement with Remedium Bio to develop gene therapies for obesity and type 2 diabetes, Remedium said yesterday.
    • “This is part of a movement by pharma companies to develop longer-lasting treatments for obesity, which they argue will be more attractive to patients than the current therapies that are injected once a week. Novo Nordisk, along with Wave Life Sciences and Arrowhead Pharmaceuticals, have been studying the potential of using RNA-interference to treat obesity.
    • “However, it’s not yet clear how feasible it would be to create a long-lasting treatment for obesity, much less one that is a one-time therapy. Some experts also fear an over-medicalized approach to addressing the issue of high obesity rates. (We wrote about all that in an earlier story here.)
  • Per MedTech Dive,
    • “Boston Scientific has agreed to buy Elutia’s two bioenvelope products for $88 million, the companies said Tuesday.
    • “The agreement will give Boston Scientific control of Elupro and Cangaroo, devices designed to promote wound healing to prevent complications after pacemaker or defibrillator implantation. 
    • “Elupro and Cangaroo compete with Medtronic’s TYRX. BTIG analysts said in a note to investors that they believe “the Elupro bioenvelope may offer clinical and handling advantages over TYRX.”
  • Per Fierce Healthcare,
    • “Oracle Health is using its data and technology muscle to move out ahead in the healthcare AI arms race.
    • “Electronic health record companies are moving quickly to integrate AI tools into their platforms as advances with agentic AI open up new opportunities to tackle clinical workflows along with revenue cycle, patient communications and even clinical trial recruitment.
    • “Oracle, which owns EHR company Cerner (now Oracle Health), touted its latest AI capabilities for providers and AI-powered EHR features Thursday morning during its Health and Life Sciences Summit in Orlando, Florida.
    • “The data and technology company is putting more focus on its AI, data and cloud capabilities as rival Epic is also ramping up its AI tech within its EHR while also extending its reach to payers, life sciences and medical device companies.”
  • Radiology Business adds,
    • “Experts are pushing for new generalist radiology artificial intelligence models that move beyond single tasks and consolidate image interpretation assistance into one total package. 
    • “Scientists made their case in an editorial published Tuesday by Radiology, noting that narrow AI solutions suffer from financial limitations such as unsustainable price scaling and market fragmentation. Generalist AI could address these and other clinical and operational challenges, producing comprehensive reports that reduce radiologist effort and “unlock new value propositions.” 
    • “Recent advancements such as foundational models—trained on diverse datasets and adaptable to a wide range of downstream tasks with minimal training—pave the way for this method.”