Midweek update

HIPAA Privacy and Security Rules

Midweek update

David Ermer–CDC, Congress, FDA, Federal employment benefits, Generative AI, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The government shutdown is over. Per the Wall Street Journal,
    • “The GOP-led House passed a spending package reopening the government and President Trump signed it into law late Wednesday, drawing to a close a record-long 43-day shutdown driven by Democrats’ demands to extend expiring healthcare subsides.
    • “The House approved the measure 222 to 209, largely along party lines, two days after the bill cleared the Senate.”
  • The Washington Post reports,
    • “Federal paychecks will begin going out Saturday, a senior administration official said, speaking on the condition of anonymity to discuss personnel matters.
    • “The deal will fund the government through Jan. 30, pass three appropriations bills, reverse more than 4,000 federal layoffs the Trump administration attempted to implement earlier in the shutdown and prevent future layoffs through the end of January. It will appropriate funding for the Supplemental Nutrition Assistance Program, also known as SNAP or food stamps, through September 2026.”
  • The Wall Street Journal discusses the secret meeting that led to this outcome.
    • “A group of centrist Democrats and an independent senator initiated talks with Senate Republicans to end the government shutdown, negotiating without Senate Minority Leader Chuck Schumer.
    • “The negotiations led to an agreement to reopen the government, but it divided Democrats as it didn’t guarantee the extension of expiring Obamacare health-insurance subsidies.
    • “Eight Democrats ultimately supported the deal, providing the critical votes needed to advance the measure to reopen the government with a 60-40 vote.”
  • Beckers Health IT tells us,
    • “Sen. Bill Cassidy, R-La., is pushing to tighten protections for health information gathered by wearable devices and mobile health apps, citing growing privacy concerns as the technology becomes more common, Politico reported Nov. 11.”
  • Per a Senate news release,
    • “On Wednesday, November 19, [at 10 am ET] the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing on the U.S. Organ Procurement and Transplantation Network (OPTN) and improving access to lifesaving organs.” * * *
    • “Click here to watch live.”
  • Per the Federal Register, the CDC’s Advisory Committee on Immunization Practices will meet on December 4 and 5, 2025.
    • “The agenda will include discussions on vaccine safety, the childhood and adolescent immunization schedule, and hepatitis B vaccines. The agenda will include updates on ACIP workgroups. Recommendation votes may be scheduled for hepatitis B vaccines. Vaccines for Children (VFC) votes may be scheduled for hepatitis B vaccines. Agenda items are subject to change as priorities dictate. For more information on the meeting agenda, visit https://www.cdc.gov/acip/index.html.” * * *
    • “The docket will be opened to receive written comments November 13 – 24, 2025. Written comments must be received no later than November 24, 2025.”
  • Neil Cain, writing in Govexec, discusses the Medicare Part B late enrollment penalty for folks enrolled in the FEHB program.

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration is unveiling a new blueprint for the regulation of bespoke drug therapies, announcing on Wednesday a way for these treatments to quickly get to market if they meet certain standards.
    • “Called the “plausible mechanism” pathway, the new framework is designed to help accelerate treatments for serious conditions that are so rare they may only affect individuals or handfuls of people and can’t feasibly be tested in randomized clinical trials. It was announced through an article authored by FDA Commissioner Martin Makary and top deputy Vinay Prasad and published Wednesday in the New England Journal of Medicine.
    • “Critics may contend that there is no need for an alternative pathway and that existing FDA operations are able to address bespoke, transformative therapies,” they wrote. “Unfortunately, the FDA has heard from patients, parents, researchers, clinicians, and developers that current regulations are onerous and unnecessarily demanding, provide unclear patient protection, and stifle innovation. We share this view.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP relates,
    • “Arizona and Utah reported an increase in measles case counts today, as did South Carolina, according to state dashboards. 
    • “The outbreak that straddles the Utah-Arizona border has now grown to 182 cases, and is the second largest measles outbreak this year following the West Texas outbreak, which sickened at least 762 people, with three deaths.” * * *
    • “The Upstate outbreak in South Carolina also grew, with eight more cases reported by the South Carolina Department of Public Health today. The state total is now 46.
    • “Six of the eight new patients are household members of previously identified patients. All new patients are in quarantine. 
    • “Two cases, however, occurred within the same household, but the source of infection is unknown.”
  • and
    • “A test-negative, case-control study across 14 hospitals in England finds that the respiratory syncytial virus (RSV) pre-F (Abrysvo) vaccine helps protect against related hospital admissions in older adults. 
    • “For the study, published in The Lancet Infectious Diseases, UK researchers identified 1,006 adults aged 75 to 79 hospitalized with acute respiratory illness (ARI) from October 2024 to March 2025. The participants were predominantly White, with a mean age of 80 years and had a high rate of chronic conditions such as heart and respiratory disease and immunosuppression. 
    • “The researchers noted that while the RSV vaccine has been shown to protect against all-cause RSV-associated hospital admissions, there’s limited data on the vaccine’s effectiveness against different RSV-associated illnesses and complications such as exacerbation of chronic illness.”
  • Per a November 11, 2025, City of Philadelphia news release,
    • “The Philadelphia Department of Public Health is notifying travelers and others who were at the Philadelphia International Airport Terminals A and B on Sunday, November 9, 2025, between 8:50 am and 4:00 pm of a possible measles exposure. The individual with measles was traveling through the airport. The Health Department is encouraging people who were exposed to check their vaccination status and watch for symptoms.”
  • Biopharma Dive reports,
    • “An antimalarial drug developed by Novartis could become the first novel treatment for the parasitic infection in more than two decades, following study results that showed it helped cure most people treated with it in a Phase 3 trial.  
    • “According to Novartis, the therapy, known in short as GanLum, was “non-inferior” to standard treatment in a trial evaluating it in 1,688 adults and children. By one analysis, the drug helped clear symptoms and signs of initial infection in 97% of recipients after 28 days, versus 94% among those receiving standard drugs. By another, that cure rate was as high as 99%. Novartis added that treatment appeared effective against drug-resistant parasites and was able to block disease transmission.
    • “The results cleared the World Health Organization’s 95% target and positions Novartis to seek approvals of GanLum “as soon as possible,” the company said in a statement Wednesday. If so, it would help combat growing resistance to a class of medicines, called “artemisinins,” that have been the gold standard for treating malaria since 1999.” 
  • The New York Times informs us,
    • “In a modern glass complex in Geneva last month, hundreds of scientists from around the world gathered to share data, review cases — and revel in some astonishing progress.
    • “Their work was once considered the stuff of science fiction: so-called xenotransplantation, the use of animal organs to replace failing kidneys, hearts and livers in humans.
    • “But as the scientists traded notes, it became ever more clear that it wasn’t fiction anymore. They were nearing breakthroughs that might help alleviate the shortage of donor organs plaguing every nation.
    • “Transplants with organs from genetically modified pigs, designed not to trigger rejection by the human body, have begun to show great promise. “The future is here,” said Dr. Muhammad M. Mohiuddin, the outgoing president of the International Xenotransplantation Association, which hosted the conference.”
  • Per Beckers Oncology,
    • “GLP-1 medication use was associated with lower mortality among colon cancer patients, according to a study published Nov. 11 in Cancer Investigation. 
    • “Researchers from the University of California San Diego used real-world clinical data from the University of California Health Data Warehouse to assess any association between GLP-1s and five-year mortality in 6,871 colon cancer patients.”
  • Per a JAMA Cardiology report,
    • “In this cross-sectional study among a nationally representative sample, chronic kidney disease (CKD) affected 1 in 7 US adults, yet fewer than 15% of adults with CKD were aware of their diagnosis. Although overall awareness increased modestly from 2011 to 2020, younger adults, women, and Hispanic adults experienced lowest awareness rates without improvement. These findings highlight a significant gap in CKD recognition and underscore the need for targeted strategies to improve awareness in the population.”
  • The Los Angeles Times reports,
    • “Food always powered Anahi Araiza through study sessions and cultural gatherings. But after putting on some weight in her college years, she decided to get serious about weight loss, often restricting her food consumption overall — and that’s when everything shifted.
    • “One day, I overate whatever calories or macros I established for myself,” says Araiza in a phone call. “Then it turned into a spiral where every single day I was unable to do anything but think about food.”
    • “After a while, she developed binge eating disorder (BED), which is defined as repeated episodes of binge eating, or eating large amounts of food quickly.””
    • “BED is the most common eating disorder in the United States, yet it is chronically underdiagnosed among Latino communities.”
  • Neurology Advisor lets us know that “Early Administration of Remote Electrical Neuromodulation Enhances Migraine Relief.”
  • Per Radiology Business,
    • “New research is raising questions pertaining to the effectiveness of a newer Alzheimer’s treatment that has been proven to reduce cognitive symptoms related to the disease. 
    • “Lecanemab, sold under the brand name Leqembi, was approved by the U.S. Food and Drug Administration in January 2023. The monoclonal antibody treatment treats early Alzheimer’s disease (AD) by essentially scrubbing the brain of amyloid-β (Aβ) plaques.   
    • “The drug’s approval was roundly celebrated at the time, as clinical trials suggested it could reduce Alzheimer’s-related cognitive decline by up to 27%. Post-approval data has been positive as well, but new research out of Osaka Metropolitan University in Japan is prompting new questions on the mechanisms that underlie the drug’s therapeutic effects. 
    • “Published in the Journal of Magnetic Resonance Imaging, the findings suggest lecanemab does not change the waste clearance function in the brains of AD patients in the short term. This could indicate that the medication does little to treat the nerve damage AD has inflicted on the glymphatic system, which clears waste from the brain, prior to starting the treatment.” “
  • Per Medscape,
    • “Statin therapy remains a cornerstone for primary and secondary prevention of major adverse cardiac events (MACEs) but prescribing based on patient phenotype identified through imaging may boost its effectiveness, according to a new study.
    • “While population-level primary-prevention trials have established the efficacy of statins, it remains unclear whether their benefit depends on the extent of underlying atherosclerotic disease. Our work addresses this evidence gap by assessing whether the treatment effect varies with disease characteristics,” lead investigator Bálint Szilveszter, MD, PhD, a researcher at the Semmelweis University Heart and Vascular Centre in Budapest, Hungary, wrote in an email to Medscape Medical News.
    • “Clarifying this relationship could enable more personalized and also intensified therapy,” Szilveszter added.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Key provider performance metrics appear steady in aggregate but are showing stark differences between hospitals and practices at the top and bottom of their class, according to a pair of new reports from Kaufman Hall.
    • “For hospitals, the firm’s operating margin index was 2.9% across nine months of 2025 (including health system allocations for the cost of shared services), a slight uptick from the 2.5% reflected through eight months. Splitting the report’s 1,300 nationwide hospitals into quartiles, however, showed a 14.7% year-to-date operating margin index among the top 25% of hospitals and a -1.8% year-to-date operating margin for the bottom quartile of hospitals.
    • “The gap between strong performers versus struggling hospitals continues to widen,” said Erik Swanson, managing director and data and analytics group leader with Kaufman Hall, said of the trend in a release.
    • “Broadly speaking, the overall margin improvement from August to September stemmed from greater volumes and per-adjusted-admission revenue gains and was partially mitigated by higher supply and drug costs, according to the firm’s monthly report. On a month-over-month basis, daily net operating revenue rose 4%, daily total expense rose 3% and daily adjusted discharges increased 2%.”
    • “As for practices, Kaufman Hall’s quarterly check-in highlighted, for the first time since the COVID-19 pandemic, a sequential decline in the median investment/subsidy per provider in medical groups. That metric—net patient service revenue minus total expense, then divided by provider full-time equivalents—was $237,911 in Q3, a 1% year-over-year increase but a minor dip from Q2’s $239,338.
    • “Similar to hospitals, however, Kaufman Hall found a disparity within the report’s sample of 200,000 providers. The investment/subsidy per provider at the 25th percentile was $141,371, but $325,634 at the 75th percentile.”
  • and
    • “The country’s largest for-profit hospital chain isn’t sitting on its hands when it comes to artificial intelligence.
    • “Speaking Wednesday morning at the 2025 UBS Global Healthcare Conference, HCA Healthcare Executive Vice President and Chief Financial Officer Michael Marks offered an update on key clinical, operational and administrative deployments of AI tools across the 191-hospital system.
    • “Broadly, I’m pleased with where we are,” Marks said. “We’re in early innings with this effort. We’re trying to be judicious in our allocation of resources and making sure that we’re getting either a clinical or a financial return on these investments as we scale them.”
    • “Clinical use cases are the steepest hill for AI due to the “inherent risks” around patient safety, the executive said, and as such are taking longer to roll out. Still, HCA has multiple projects aimed at improving patient safety and quality outcomes, among which is a partnership with Google to tighten the roughly 400,000 weekly shift handoffs between the system’s nurses.”
  • MedCity News considers “What Are the Biggest Mistakes Employers Make When Introducing Digital Mental Health Solutions? At the Behavioral Health Tech conference, panelists said employers often rush to adopt digital mental health tools without tailoring them to employee needs or effectively promoting their use.”
  • HR Dive informs us,
    • “Employers significantly misjudge how well their benefit offerings are meeting employee demands: While 75% believe their workforce is satisfied with what they offer, only 65% of employees agree, according to Aflac’s 2025-2026 benefits trend report.
    • “One noticeable misunderstanding involves communication, spring surveys of 1,002 employers and 2,000 employees across the U.S. found. Nearly 2 in 5 (37%) of employees said they want to talk to a real person to help with benefits enrollment, but only 28% of employers offer this option. Similarly, 32% of employees said they want one-on-one access to a benefit consultant, but only 28% of employers provide it.
    • “Employers are also out-of-touch with employee concerns about medical bills: 78% believe employees can handle this financial burden, but 44% of workers say they couldn’t cover $1,000 in unexpected health expenses. Almost 1 in 5 (19%) said they wouldn’t be able to afford $500 in healthcare costs.”

Monday report

David Ermer–CDC, Congress, COVID-19, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • The Roll Call informs us,
    • “Appropriators could finish drafting a compromise version of a three-bill spending package for fiscal 2026 in “two or three days” once the partial government shutdown is over, House Appropriations Chairman Tom Cole, R-Okla., said last week.
    • “The shutdown has stalled work on full-year appropriations for more than three weeks, but Cole said lawmakers in both chambers are close to finishing compromise drafts of the Agriculture, Legislative Branch and Military Construction-VA bills. Those can’t move forward, however, until the government reopens, he said.”
  • The Wall Street Journal adds,
    • “The nation’s largest federal workers’ union called for Congress to end the shutdown now in its fourth week, putting new pressure on Senate Democrats who have repeatedly blocked a Republican measure to reopen the government.
    • “It’s time to pass a clean continuing resolution and end this shutdown today,” said Everett Kelley, president of the American Federation of Government Employees, or AFGE, which represents more than 800,000 employees, referring to a short-term spending bill.
    • “Kelley called the situation an “avoidable crisis” that is harming families and communities. “Both political parties have made their point, and still there is no clear end in sight,” he said.
    • “The union’s demand—a clean continuing resolution—is the same approach the Republicans have urged Democrats to adopt for the past month, though AFGE didn’t mention either party by name. The union didn’t immediately reply to a request for comment.”
  • The Hill notes,
    • “Speaker Mike Johnson (R-La.) on Monday said House Majority Leader Steve Scalise (R-La.) is working with the chairs of three House committees to compile a Republican health care plan as the government shutdown nears the one-month mark and Democrats demand action on expiring ObamaCare subsidies.” * * *
    • “The heads of those House committees of jurisdiction involved in the health care plans would be Ways and Means Chair Jason Smith (R-Mo.), Energy and Commerce Chair Brett Guthrie (R-Ky.), and Education and Workforce Chair Tim Walberg (R-Mich.).”
  • The Defense Department issued a Federal Register notice describing TRICARE benefit changes for 2026.
  • Per an ERISA Industry Committee news release,
    • “The ERISA Industry Committee (ERIC) and employee benefit industry groups today urged The U.S. Departments of Labor, Health and Human Services, and Treasury (the Tri-Departments) to take immediate action to address severe negative consequences of the Independent Dispute Resolution (IDR) process under the No Surprises Act. Despite the Act’s clear goals of protecting patients from surprise medical bills and fostering fair payment negotiations, employers warn that certain providers have increasingly exploited the IDR process.” * * *
    • “The employers called on the Tri-Departments to take three immediate steps to restore the legitimacy of the IDR system, including:
      • Strengthen enforcement to ensure only eligible claims are submitted to IDR.
      • Increase transparency in arbitration decisions and require clear rationale when awards deviate from the qualified payment amount (QPA).
      • Penalize abuse by providers who repeatedly submit ineligible claims.
    • Read the entire employer letter here
  • Federal News Network tells us,
    • “Current and former federal employees affected by the massive 2015 Office of Personnel Management data breach may be losing their identity protection services in the coming year.
    • “IDX, the company providing these services since 2015, sent out emails earlier this month telling recipients of their identity protection services that they would have to renew on their own dime after receiving services for 10 years paid for by the government.
    • “IDX, which has held the identity protection and credit monitoring contract since 2015, sent at least three emails out over the last few weeks offering customers a discount to renew their subscriptions.”
  • Fierce Pharma notes,
    • “More and more, as momentum builds for the soon-to-be-blockbuster Winrevair, Merck’s $11.5 billion buyout of Acceleron in 2021 is looking like a savvy move.
      The FDA has signed off on a label update for the first-in-class activin signaling inhibitor, which was the key piece of the acquisition. The new approval adds language to the medicine’s label about its ability to reduce patients’ risk of hospitalization for pulmonary arterial hypertension (PAH), lung transplantation and death.
    • “Paving the way for the label update were results from the phase 3 Zenith trial, which enrolled 172 PAH patients at the highest risk of mortality—those in the World Health Organization Functional Class (FC) III or IV—and achieved its primary endpoint of time to clinical worsening to first morbidity or mortality event.
    • “Winrevair, added to maximum background therapy, reduced the risk of these events by 76% versus placebo. Patients in the trial’s treatment cohort received a subcutaneous dose of Winrevair every three weeks, and the median follow-up with patients was 10.6 months.”

From the public health and medical / Rx research front,

  • MedPage Today points out,
    • Hormel Foods is recalling nearly 4.9 million pounds of frozen boneless chicken it sold to restaurants, cafeterias, and other outlets after customers reported finding metal in the products, the U.S. Department of Agriculture (USDA) announced. (AP)
    • And a South Dakota company is recalling more than 2.2 million pounds of Korean barbecue pork jerky sold at Costco and Sam’s Club stores, again because the product may be contaminated with pieces of metal, USDA said. (AP)
  • The Hill relates,
    • “More than two years after the mpox outbreak in the U.S. was declared over, a new crop of cases in California has infectious disease experts on edge. 
    • “The mpox outbreak that spread through men who have sex with men was declared over at the start of 2023, though low-level transmission has persisted since then.” * * * 
    • “A collection of three unrelated mpox cases recently detected in California is raising concerns, as they were caused by a more infectious, more dangerous strain of the virus called clade I mpox.”
    • “Joseph Cherabie, a member of the HIV Medicine Association board of directors and assistant professor of infectious diseases at Washington University St. Louis, said it was “only a matter of time” before clade I mpox was detected in the U.S.” * * *
    • “If we learned anything from the 2022 outbreak, casual contact, and, you know, transmission through things like clothing, shared clothing, or sitting on the same seat in a subway or anything like that — that did not occur,” Cherabie said. “You need very close, intimate contact with these lesions. So that is why the predominant means of transmission previously was through sexual contact.”  
  • Your Local Epidemiologist writes in her Substack blog to which the FEHBlog subscribes,
    • “After an unusually quiet October for respiratory viruses, an RSV wave is starting to take hold. Flu remains remarkably low, and Covid-19 transmission is at one of the lowest points we’ve seen in months.
    • “Although CDC data remain paused because of the federal government shutdown, emergency department records compiled by PopHIVE show RSV activity is starting to climb, especially among children under four. This follows a familiar pattern: the virus first hits the youngest children (particularly those under one year) before spreading to adults, often about a month later.”
  • The American Medical Association tells us what doctors wish their patients knew about ovarian cancer prevention. “What is known about risk factors has not translated into practical ways to prevent most cases of ovarian cancer. Three ob-gyns share what to keep in mind.”
  • The New York Times reports,
    • “Surgeons removed a genetically modified pig kidney from a 67-year-old man last week, nearly nine months after he received the pioneering procedure at Massachusetts General Hospital in Boston, officials said on Monday. The kidney was removed “after a period of decreasing kidney function,” according to a statement from the hospital.
    • “The patient, Tim Andrews, lived with the pig kidney for a record-setting 271 days. He was the fourth person in the United States to receive a genetically modified pig kidney. The first two patients died shortly after their transplants; the third had her kidney removed after 130 days, when her body rejected the organ.
    • “Tim set a new bar in xenotransplantation,” the Mass General Brigham statement said, referring to the process of transplanting organs from one species into another.
    • “Mr. Andrews “will now resume dialysis and remain on the list for a human donor kidney,” the hospital added.
    • “The nation faces an acute shortage of human organs. More than 100,000 people are on waiting lists to receive an organ transplant; roughly 90,000 of them are awaiting kidneys.
    • “The shortage has prompted an effort to genetically modify pigs so that their organs can be safely transplanted into humans.”
  • Per MedPage Today,
    • “Surgery alone offered improved survival and a potential cure for select pancreatic cancer patients.
    • “Clear surgical margins and negative lymph node status were essential to better survival.
    • “The findings came from a registry database, not a randomized clinical trial.”
  • and
    • “Estetrol (E4) — one of four natural estrogens — significantly reduced the weighted weekly score of moderate-to-severe vasomotor symptoms in postmenopausal women, according to an analysis of two phase III trials.
    • “Among more than 1,200 women included in E4COMFORT I and E4COMFORT II, the weekly weighted score (WWS) of vasomotor symptoms (VMS), which combined the number and severity of hot flashes, decreased in all treatment arms, including placebo, reported Ekta Kapoor, MBBS, of the Mayo Clinic in Rochester, Minnesota, at the Menopause Society annual meeting
    • “Both examined doses of once-daily oral E4, 15 mg and 20 mg, resulted in greater and statistically significant reductions compared with placebo, and the 20-mg dose demonstrated the largest and earliest reductions, Kapoor reported.”
  • The Washington Post reports,
    • “A sweeping study found thousands of stillbirths occur without clear warning signs
    • “A study led by researchers at Harvard and Mass General Brigham shows stark socioeconomic divides and thousands of unexplained losses, even in seemingly healthy pregnancies.
    • “The study published Monday shows that nearly 30 percent of stillbirths occur in pregnancies that did not appear linked to any previously identified health or clinical risks. The study also found that stillbirth continues to fall unevenly along racial and socioeconomic lines, with Black families and poorer communities being hit hardest.”
    • “Mark Clapp, an obstetrician and maternal-fetal medicine specialist at Massachusetts General Hospital and one of the study authors, said better screening and monitoring are urgently needed.”
  • Per Health Day,
    • Lousy sleep might be an early warning sign for suicide risk among teenagers, a new study says.
    • Teenagers who didn’t get enough sleep on school nights or suffered from interrupted sleep had a significantly higher risk of suicide, researchers reported Oct. 23 in the journal Sleep Advances.
    • “Adolescents who experience difficulties maintaining and obtaining sufficient sleep are more likely to report a suicide attempt several years later,” said lead researcher Michaela Pawley, a doctoral candidate in psychology at the University of Warwick in the U.K.
    • “Poor sleep is not just a symptom of wider difficulties, but a significant risk factor in its own right,” Pawley said in a news release. “Addressing sleep problems could form a vital part of suicide prevention strategies.”
  • Per STAT News,
    • “Experimental CAR-T therapies from Cabaletta Bio and Bristol Myers Squibb have induced complete remissions in patients living with a severe inflammatory muscle disease, results from dual clinical trials being presented this week show. 
    • “The new data, while still preliminary, add to evidence reported over the past several years that personalized cell therapies — already used to treat blood cancers — may be curative for patients with serious autoimmune disorders.
    • “These are patients who take three-to-five medicines every day, every week, every month, at great cost both healthwise and financially,” said Steven Nichtberger, CEO of Cabaletta. With a one-time CAR-T treatment, “We’re showing we can eliminate all of those drugs, giving them the opportunity to no longer be patients. We are freeing them from their disease.” 
  • BioPharma Dive relates,
    • “Shares of Intellia Therapeutics lost nearly half their value Monday a serious safety event led the company to temporarily pause a pair of Phase 3 trials testing its gene-editing drug against the rare disease transthyretin amyloidosis.
    • “Intellia said it has stopped enrollment and dosing in both late-stage studies of the therapy, codenamed nexiguran ziclumeran or nex-z, while it works on new measures to ensure patient safety. The company plans to consult with regulators and independent experts to “develop a strategy to resume enrollment as soon as appropriate,” CEO John Leonard said in the statement.
    • “The enrollee, a man in his 80s and treated on Sept. 30, on Friday experienced a “grade 4” spike in liver enzymes that were concerning enough to require hospitalization. Prior to the stoppage, Intellia had already enrolled more than 650 people with the cardiomyopathy form of transthyretin amyloidosis in one trial and 47 with the polyneuropathy form in its other study.”
  • and
    • “An experimental medicine from BridgeBio Pharma succeeded in a late-stage study in a form of limb-girdle muscular dystrophy, positioning the company to engage U.S. regulators about a potential approval filing. 
    • “Study volunteers with that “type 2I/R9” form of limb-girdle and treated with the drug, BBP-418, had a roughly 17% improvement after three months in “αDG glycosylation,” an important marker of muscle stability and the trial’s main objective. That increase was sustained after 12 months, compared to no change on this measure among placebo-treated participants. No new or “unexpected” safety findings were observed, the company said Monday. 
    • “BridgeBio also said drug recipients had “statistically significant” and “clinically meaningful” improvements after a year in all key trial endpoints studied, including measures of walking ability and lung function. The company will discuss the results with the FDA later this year and intends to submit an approval application in the first half of 2026.” 

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Cigna’s Evernorth division is rolling out a rebate-free model for its pharmacy benefit manager, Express Scripts—meaning one of the industry’s “Big Three” is moving away from the oft-criticized approach.
    • “Cigna announced Monday morning that what it’s calling a “new era” for its PBM unit is built on three core elements: transparency, a better patient experience and greater support for community pharmacies. The company said that Evernorth will shift to a pass-through model, where discounts are available upfront to members.
    • “Cigna’s insurance arm, Cigna Healthcare, will adopt this model for its fully insured plans in 2027, and the more transparent model will be the standard offering for all of Express Scripts’ customers beginning in 2028.
    • “Pharmacy benefit managers have successfully driven down costs for Americans with generics and now with biosimilars,” said Adam Kautzner, president of Evernorth Care Management and Express Scripts, in the release. “In this new era of pharmacy benefits, we’re creating more choice for Americans by lowering the costs of expensive brand-name drugs while driving accelerated adoption of generics and biosimilars.”
    • “Our innovative model is a win-win for Americans and their employers—lower costs for Americans, real-time transparency for employers and renewed trust in pharmacy benefits for all,” Kautzner said.
    • Per the announcements, Evernorth estimates that the new model will save members an average of 30% each month on brand-name medications. It will lean on technology to compare pricing options for the patient and ensure they see the lowest cost when they pick up a prescription.
  • Brilliant.
  • Beckers Payer Issues lets us know,
    • “Blue Cross Blue Shield of Massachusetts is expanding its claims review process to address what it is describing as potential overcoding among physicians who routinely bill for high-complexity visits.
    • “The new policy takes effect for dates of service on or after Nov. 3 and applies to a small subset of clinicians whose billing patterns stand out from peers, BCBSMA told Becker’s.
    • “Under the program, BCBSMA will review evaluation and management claims from providers who consistently bill visits at the highest complexity levels (4 and 5) to ensure that the services billed match the severity of the conditions reported. Reimbursement may be reduced if the insurer decides that overcoding has occurred.
    • “BCBSMA estimates that 1% to 2% of primary care physicians and 3% to 4% of specialists in its network will be subject to the expanded process. Clinicians can submit additional documentation and appeal to have claims reinstated as originally billed.”
  • Per Medical Economics,
    • “Sites of care, price transparency, competition and consolidation all play a role in U.S. health care in 2025, and likely will in coming years.
    • “There also could be changes in store — and there should be, if the nation wants to improve the value of a vital service now accounting for almost 20% of America’s gross domestic produce, according to health care economic analyst Trilliant Health.
    • “The new report, “2025 Trends Shaping the Health Economy,” posits that the health care system is at a crossroads with a choice to make: find ways to improve outcomes and value from within, or face new external regulation that might not be what the sector wants.”
  • and
    • “A new KFF/Washington Post survey offers a detailed look at how American parents view their children’s health — and who they trust most for medical guidance. Conducted in summer 2025, the survey shows a nation largely united in concern over issues like mental health and diet, but deeply divided on vaccines, public health institutions and the balance between personal freedom and medical authority.
    • “For physicians, the results underscore a growing need to rebuild and reinforce trust at the point of care, as families increasingly navigate conflicting messages from social media, politics and federal agencies.
    • “Find an in-depth analysis of the survey’s findings here.”
  • Per Fierce Healthcare,
    • “Community Health Systems (CHS) announced Friday evening a new definitive agreement to sell three Pennsylvania hospitals to affiliates of Tenor Health Foundation, a recently formed nonprofit. 
    • “Early discussions on the deal and a signed letter of intent had been reported during the summer and confirmed at the time by company representatives. The deal is a second attempt for CHS to sell off its Commonwealth Health system after a prior purchase agreement with WoodBridge Healthcare was called off last year. 
    • “Involved in the transaction are the 186-bed Regional Hospital of Scranton, the 122-bed Moses Taylor Hospital and the 369-bed Wilkes-Barre General Hospital, as well as their affiliate sites.
    • “Financial terms of the deal are not being disclosed. CHS said in its announcement that a close is contingent on Tenor finalizing its funding, as well as on customary regulatory approvals.”   
  • Per Beckers Hospital Review,
    • “Nearly 75% of active drug shortages in the U.S. began in 2022 or earlier, with some persisting for more than five years.
    • “According to a report from the American Society of Health-System Pharmacists released in September, the number of active shortages declined to 214 in the third quarter of 2025 — the lowest since early 2018 and a steep drop from the record 323 reported in the first quarter of 2024. While the trend is improving, the ASHP warned that persistent shortages of commonly used medications, including lorazepam and triamcinolone injections, continue to disrupt care.
    • “Long-term shortages now account for most active disruptions, with the ASHP noting that nearly 75% began in 2022 or earlier. These prolonged gaps in supply often require health systems to modify treatment plans, locate alternatives and update clinical workflows.”

Friday report

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

From Washington, DC,

  • The FEHBlog was pleased to see that OPM Director Scott Kupor added his regular Friday post to his OPM blog today after adding an insightful special post yesterday about the combined federal campaign. This Friday’s post concerns artificial intelligence.
  • MedTech Dive reports,
    • “A bipartisan bill introduced in Congress this week aims to more accurately determine Medicare reimbursement for laboratories by tying payment rates for diagnostic tests to a not-for-profit commercial claims database.
    • “The legislation would reform the 2014 Protecting Access to Medicare Act, also known as PAMA, which the lab industry for years has argued created a process that sets reimbursement rates artificially low.
    • “Called the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act, the new bill would “dramatically improve” the data used to set rates for lab tests, the American Clinical Laboratory Association said Thursday.”
  • OPM released on the Federal Register’s Public Inspection List a final rule titled “Assuring Responsive and Accountable Federal Executive Management. Here’s the summary of the rule,
    • “The Office of Personnel Management (OPM) is issuing this final rule to remove the prohibition of a forced distribution of performance rating levels within the Senior Executive Service (SES) as well as eliminate diversity, equity, and inclusion (DEI) language within SES performance management regulations. Governmentwide SES ratings data have consistently shown that most SES receive the highest rating levels (i.e., Levels 4 and 5) despite documented reports of SES failings. Allowing agencies to limit the highest SES rating levels will increase rigor in SES appraisal and lead to a more normalized distribution of SES ratings across the Federal Government.
    • The rule will be published in the Federal Register on September 15.
  • Per an HHS news release.
    • “The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will hold a meeting on Thursday and Friday, September 18-19, 2025, in Atlanta, GA. * * *
    • “The meeting will be available to the public via live webcast. The link will be available Thursday morning on the ACIP website. 
    • “The September 18-19 meeting draft agenda will be available on the ACIP website.” 
  • The Groom Law Group lets us know,
    • “The HIPAA Security Rule requires covered entities, such as group health plans and health insurance issuers, as well as business associates, to perform a written “security risk assessment” of the potential risks and vulnerabilities to protected health information (“PHI”) maintained on their systems and applications. 
    • Yesterday [September 10], the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) released an updated version of the Security Risk Assessment Tool (“SRA Tool”), which is an easy-to-use interactive application that covered entities and business associates can use to create the required security risk assessment.  The SRA Tool guides users through the required security risk assessment process using a series of multiple-choice questions, providing references and guidance along the way.  The updated SRA Tool offers new features, including a glossary, tips, and a remediation report.  
    • The OCR and Assistant Secretary for Technology Policy will host live webinars with training sessions on September 15 at 12:00 p.m. ET and September 16 at 3:00 p.m. ET.  You can register for the training sessions here.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “The FDA is signaling fresh control over the promotion of copycat drugs under President Donald Trump’s executive order to rein in pharmaceutical advertising, staking a position in a regulatory gray area around so-called compounded products.
    • “On Tuesday, Trump’s executive order called for “action to ensure transparency and accuracy in direct-to-consumer prescription drug advertising.” 
    • “The Food and Drug Administration then sent hundreds of letters to drug companies warning of deceptive promotions, which included notices to online telehealth companies that market the compounded products, a spokesperson for the US Department of Health and Human Services said in an email. 
    • “The FDA is clearly looking to take a more aggressive stance with deceptive advertising practices, and that will include non-traditional targets,” said Melissa Wong, a life sciences attorney at Holland & Knight.”
  • STAT News tells us,
    • “Mark your calendars — the Food and Drug Administration will soon convene experts to discuss challenges around regulating mental health products that use artificial intelligence. The announcement arrives as a growing number of companies release chatbots powered by large language models with unpredictable output.
    • “Notice of the Nov. 6 meeting of the Digital Health Advisory Committee, published Thursday in the Federal Register, says newly released mental health products using AI pose “novel risks and, as mental health devices continue to evolve in complexity, regulatory approaches ideally will also evolve to accommodate these novel challenges.” 
    • “The agency has yet to provide clear guidance on how it plans to regulate these devices or what developers must do to show they are safe and effective. But it’s clear the risks are real, as I detailed in my story last week about ChatGPT and other generative AI tools driving users into delusional spirals. Read more from STAT’s Mario Aguilar.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive tool designed to facilitate the public’s ability to query real-time adverse event data on cosmetic products. The user-friendly platform allows users to download report listings or data sets, with reports being updated daily to include the most recent submissions.
    • “Today’s launch marks another step in the FDA’s modernization strategy, which includes radical transparency. It follows the agency’s recent announcement on real-time reporting of adverse event and medication errors data for drugs and therapeutic biologics.” * * *
    • Reports in this dashboard have not been verified by the FDA, and their publication does not indicate that the FDA has concluded the product caused the adverse event. Additionally, the FAERS data is not an indicator of the safety profile of the cosmetic product. To learn more, read the frequently asked questions.
  • On a related note, the Wall Street Journal discusses health concerns raised about gel manicures.

From the judicial front,

  • Fierce Pharma notes,
    • “It was another swing and a miss for the biopharma industry on Thursday, when a federal appeals court in Philadelphia unanimously rejected (PDF) a challenge by Novartis on the legality of the Inflation Reduction Act (IRA) Medicare price negotiation program.
    • “It was the second time this month that the U.S. Court of Appeals for the Third Circuit swatted away an IRA challenge from Big Pharma. Last week, the same three-judge panel turned back (PDF) an appeal from Bristol Myers Squibb and Johnson & Johnson, although that decision was split.
    • “Judge Thomas Hardiman, a George W. Bush appointee, registered a dissenting opinion in the appeal brought by BMS and J&J. The other judges on the panel are Joseph Biden appointee Arianna Freeman and Donald Trump appointee Peter Phipps.”
  • Beckers Payer Issues points out,
    • “The U.S. Bankruptcy Court for the Middle District of Florida has approved a bid from Humana’s CenterWell to acquire the assets of The Villages Health, the health system serving The Villages retirement community in Florida.
    • “TVH filed for Chapter 11 bankruptcy in July. The court’s Sept. 9 decision allows the organizations to move forward with the transaction, which is expected to close in the fourth quarter, pending regulatory approvals, according to a Sept. 9 news release.
    • “The deal will bring TVH’s eight primary care centers and two specialty care centers serving more than 55,000 patients under CenterWell. CenterWell operates as a payor-agnostic provider, so TVH patients will be able to continue using their current insurance plans after the transition.”

From the public health and medical/Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is peaking in many areas of the country with elevated emergency department visits and hospitalizations nationally. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is peaking nationally. “Emergency department visits for COVID-19 are highest in children 0-4 years old and elevated in children 5-17 years old and adults 65 years and older. Hospitalizations numbers are elevated in adults 65 years and older.”
    • “Influenza
    • “RSV
      • “RSV activity is very low.
    • “Vaccination
      • “RSV immunization products will be available beginning in September across most of the continental United States. To protect against RSV-associated lower respiratory tract infections, all infants should receive either maternal RSV vaccination during pregnancy or a long-acting RSV monoclonal antibody, nirsevimab or clesrovimab.
      • “A CDC MMWR report published on August 28, 2025, outlines recommendations from the Advisory Committee on Immunization Practices (ACIP) regarding the use of clesrovimab for preventing severe RSV-related illness in infants. Clesrovimab could further increase access to and protection of infants in the 2025–26 respiratory virus season.
      • “Recommendations for use of 2025-2026 seasonal influenza vaccine have also been published in CDC’s MMWR.”
  • The American Hospital News informs us,
    • “The flu hospitalization rate during the 2024-25 flu season was the highest since 2010-11, according to a report published Sept. 12 by the Centers for Disease Control and Prevention. For all age groups, flu hospitalization rates were 1.8 to 2.8 times higher than median historical rates. Like previous seasons, most hospitalized patients (89%) had one or more underlying medical conditions, nearly 17% were admitted to an intensive care unit, 6% received assistance from a mechanical ventilator and 3% died while in the hospital.
    • “Additionally, the CDC said 32% of hospitalized patients received a flu vaccine and nearly 85% received antiviral treatment. Children and adolescents aged 5-17 received the lowest proportion of antiviral treatment at approximately 62%. The CDC recommended that all individuals older than six months receive a flu vaccine annually.”
  • The New York Times adds that a “Rare but Serious Complication Shows Flu’s Potential Harm, Acute necrotizing encephalopathy, or A.N.E., can result from influenza or other infections, including Covid-19.”
  • Health Day notes that “Comorbidities are seen less often in severe respiratory syncytial virus (RSV) infection in infants younger than 3 months compared with older children, according to a study published online Sept. 9 in The Lancet Regional Health: Europe.”
  • Per the University of Minnesota’s CIDRAP,
    • “The Los Angeles County Department of Public Health (LADPH) yesterday urged residents to make sure family members are protected from measles following the death of a school-age child who was infected with the virus during infancy and developed a rare complication from the disease called subacute sclerosing panencephalitis (SSPE). Health officials said SSPE is typically fatal in people who were infected with measles during early life.” * * *
    • “In related news, the Georgia Department of Public Health today announced another measles case, which involves an unvaccinated Fulton County resident who has no known history of international travel. The patient is no longer infectious but may have exposed others from September 2 to September 11. 
    • “Some of the exposure locations include Georgia State University, a restaurant on multiple days, and soccer games and practices.”
  • Per a National Institutes of Health press release,
    • “According to a study funded by the National Institutes of Health (NIH), older Americans with chronic low back pain who received acupuncture had greater improvement in physical function and reduced pain than those who received usual medical care only, generally prescribed medications or physical therapy. Chronic low back pain is the leading cause of disability worldwide and affects over one-third of older adults in the United States. Treatment options range from pain-relieving drugs to complementary therapies, including acupuncture. There is an urgent need for safe, effective, and non-addictive pain management approaches.
    • “Of the different treatments we have for chronic low back pain, most have a somewhat modest effect. They often reduce pain by about a third at best and can help people function better,” said lead author Lynn L. DeBar, Ph.D., Kaiser Permanente distinguished investigator. “Our clinical results suggests that acupuncture is working as well as many things that are more familiar to people. We found that the size of this effect, while modest, was positive and sustained.”
  • The Washington Post relates,
    • “Exercising muscles pumps out substances that can suppress the growth of breast cancer cells, according to an important new study of exercise and cancer.
    • “The study, published last month, involved 32 women who’d survived breast cancer. After a single session of interval training or weightlifting, their blood contained higher levels of certain molecules, and those factors helped put the brakes on laboratory-grown breast cancer cells.
    • “Our work shows that exercise can directly influence cancer biology, suppressing tumor growth through powerful molecular signals,” said Robert Newton, the deputy director of the Exercise Medicine Research Institute at Edith Cowan University in Perth, Australia, and senior author of the new study.”
  • Per the AHA News,
    • “A Gallup report published Sept. 9 found that nearly 48 million Americans currently have or are being treated for depression. The total, which equals 18.3% of the population, has significantly increased since 2019 (12.5%). The rate increased to 13.8% in 2020 — the onset of the COVID-19 pandemic — and continued to sharply increase. Adults who report having been diagnosed with depression in their lifetime are at 28.5%, nearing the record high of 29% recorded in the first quarter of 2023. The report said that reduced stigma in seeking mental health treatment may partly explain rising depression diagnoses, as 70% of Americans now prefer that their doctor ask about both physical and mental health concerns.”
  • BioPharma Dive lets us know that “signs point to potential benefits of GLP-1s in oncology. Early academic research suggests various ways weight loss drugs could have an impact in cancer care.”

From the U.S. healthcare business front,

  • The Employee Benefits Reseach Institute informs us,
    • “There were 13.1 million individuals with health care claims having employment-based benefits in 2022. However, the use of health care services is far from evenly distributed across the population. In fact, a small portion of the population accounts for a disproportionately large share of health care spending. These “high users” often have significant and complex medical needs and usually require ongoing or intensive care for one or more medical conditions. This Fast Fact is the second in a series of EBRI Fast Facts related to the concentration of health care spending and examines health care spending among individuals in employment-based health plans with the top medical conditions.”
  • Willis Towers Watson calls attention to the fact that “high-cost claims are rising fast, driven by complex conditions and specialty drugs. Employers must shift to data-driven, clinically focused strategies to manage risk and improve outcomes.”
  • Milliman explains “how to build a long-range GLP-1 forecast with the goal of estimating when could commercial health plans see a plateau?”
    • “In recent years, new treatment options for type-2 diabetes and obesity have resulted in substantial changes in clinical guidelines and prescribing patterns. Commercial payers have experienced a recent surge in the utilization of glucagon-like-peptide-1 (GLP-1) medications. Also, approved indications are expanding, including those for sleep apnea and cardiovascular conditions. This white paper provides a framework for building a long-range forecast and can help employers covering these drugs understand how trends associated with these drugs may change over time.”
  • Per Health Affairs Forefront,
    • “Industry and HHS should collaborate to develop a voluntary standardized identifier for provider networks that is consistent across all segments of the health insurance markets. To accomplish this, we propose convening a working group within an accredited standards body or industry collaboration to define the details of the standard and oversee implementation.
    • “This article examines how the lack of standardized identifiers for provider networks creates many frustrations for consumers and other health care stakeholders. It also reviews the role that standardized identifiers and standards bodies play in developing seamless consumer experiences in other industries and the roles they could play in health care in assisting consumers and other stakeholders.”
  • Beckers Hospital Review warns,
    • “Seven-hundred and fifty-nine rural U.S. hospitals are at risk of closure due to financial problems, with about 40% of those hospitals at immediate risk of closure.
    • “The counts are drawn from the Center for Healthcare Quality and Payment Reform’s most recent analysis, based on hospitals’ latest cost reports submitted to CMS and verified as current through August 2025. The analysis identifies two distinct tiers of rural hospital vulnerability: those at risk of closure and those facing an immediate risk of closure.”

Monday update

David Ermer–CDC, CMS, Federal employment benefits, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, Mental health care, Obesity, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Per an OPM news release,
    • The U.S. Office of Personnel Management (OPM) today issued new government-wide guidance to ensure that performance awards are meaningfully targeted to the highest-performing federal employees. The updated policy directs agencies to strengthen performance management practices, normalize ratings, and reserve the largest awards and bonuses for employees who have demonstrated exceptional contributions to their agencyʼs mission. The guidance also encourages agencies to expand use of non-cash awards, such as time-off and quality step increases, and to recognize real-time accomplishments throughout the year
  • Per an HHS news release,
    • “Health and Human Services Secretary Robert F. Kennedy, Jr. visited the CDC headquarters in Atlanta today in response to Friday’s tragic gunfire attack that claimed the life of DeKalb County Police Officer David Rose. 
    • “CDC security led Secretary Kennedy on a tour of the Roybal Campus, pointing out shattered windows across multiple buildings, including the main guard booth. Health and Human Services Deputy Secretary Jim O’Neill and CDC Director Susan Monarez accompanied him on the tour. 
    • “Secretary Kennedy visited the DeKalb County Police Department, where he met with Police Chief Greg Padrick. Later, he met privately with the widow of Officer David Rose, who courageously gave his life in the line of duty. He offered his deepest condolences and reaffirmed the agency’s commitment to honoring Officer Rose’s bravery, sacrifice, and service to the nation.” 

From the judicial front,

  • It occurred to the FEHBlog this afternoon that we recently passed the August 7 deadline for the parties to submit a joint status report to the federal court considering a challenge to the Biden Administration’s 2024 mental health parity rule amendments.  
    • It turns out that the status report (Dropbox link) was timely submitted on August 7.
    • The parties reported,
      • “The Departments continue to consider whether to issue a notice of proposed rulemaking to revise or rescind the 2024 Rule and to determine when it would be appropriate to add a MHPAEA regulatory action to the agencies’ Semiannual Regulatory Agenda.
      • “Pursuant to the Court’s May 12, 2025, Minute Order, the parties will file another joint status report on or before November 5, 2025, to report on Defendants’ progress.” 
    • The most recent semi-annual regulatory report appearing on reginfo.gov is Fall 2024 dated 12/13/2024.
  • Fierce Healthcare reports,
    • “Hospital and health system groups are skeptical the Trump administration will have enough time to weigh and incorporate providers’ concerns before opening its 340B rebate pilot program up to drugmaker applicants. 
    • “In a letter sent to the Health Resources and Services Administration (HRSA), which oversees the controversial subsidy program, seven provider associations requested HRSA extend the timeline for stakeholder comments and give itself a broader window to consider public comments. 
    • “Specifically, the current timeline outlined by HRSA in late July requires comments on the program to be submitted by Sept. 8, and for drugmakers to submit their applications and rebate plans by Sept. 15. Approvals would be made by Oct. 15, and the pilot is slated to begin at the top of the year 
    • “Instead, the associations have floated a Sept. 15 comment period, an Oct. 20 manufacturer application deadline and a Nov. 3 approval date.
    • “With the fundamental changes a rebate model will impose on all 340B stakeholders, it is impossible for the agency to meaningfully consider, in just seven days, all the feedback it will surely receive,” the associations wrote in their letter (PDF). “Moreover, drug companies have spent years developing and preparing for a rebate model, but the agency’s current timeline would give 340B hospitals far less time to prepare.”

From the public health and medical research,

  • The American Medical Association lets us know what doctors wish their patients knew about joint injuries and treatment.
  • Consumer Reports, writing in the Washington Post, discusses “how to get more out of physical therapy. It can reduce pain, boost strength, get you as healthy as possible for surgery and more.”
  • Medscape lets us know what doctors wish their patients knew about “How High-Fiber Diets and Supplements Can Improve Health for Patients With Obesity.”
  • Per MedPage Today,
    • “Previous research on associations between prediabetes and mortality has produced conflicting results.
    • “This study found that prediabetes was statistically significantly associated with mortality only among adults ages 20 to 54 years.
    • “Mortality risk in younger adults could be due to metabolic or behavioral risk factors.” * * *
    • “Elizabeth Selvin, PhD, of Johns Hopkins Bloomberg School of Public Health in Baltimore, who was not involved in the study, told MedPage Today that the findings were “very consistent with [the 2019 study] demonstrating that prediabetes in older adults is not strongly associated with mortality.”
    • “Current definitions of prediabetes are very broad and they capture a lot of people who are not at high risk for poor outcomes, especially in old age,” she said. “In older ages, mild elevations in glucose are extraordinarily common and seem to reflect mild metabolic dysfunction corresponding with aging rather than severe hyperglycemia that leads to diabetes.”
  • BioPharma Dive reports,
    • “An experimental cancer vaccine fell short of its main objective in a Phase 3 trial in melanoma, causing shares of the shot’s developer, IO Biotech, to fall by double digits on Monday. 
    • “IO Biotech, however, still believes the vaccine performed well enough to warrant a potential approval consideration from U.S. regulators. The company noted how the study, which compared a regimen of its shot and Merck & Co.’s immunotherapy Keytruda to Keytruda alone, failed by the slimmest of margins. Executives also pointed to other analyses showing potentially stronger benefits among those who hadn’t previously received drugs like Keytruda or aren’t likely to respond to them. 
    • “It was a very narrow miss, just by a hair,” said Mai-Britt Zocca, IO’s CEO, on a Monday conference call with Wall Street analysts.
    • “Called Cylembio, IO’s cancer vaccine consists of engineered peptides that are supposed to provoke an immune response to certain proteins expressed on tumor cells. Those proteins are two of the immune “checkpoints,” PD-L1 and IDO1, long studied by drugmakers.”
  • and
    • “An experimental Novartis drug has succeeded against a tough-to-treat autoimmune condition, boosting the outlook for a multibillion-dollar acquisition the Swiss pharmaceutical company made last year. 
    • “According to Novartis, the drug, called ianalumab, met its main goal in two Phase 3 studies in Sjögren’s syndrome, a chronic and progressive immune disease. Novartis didn’t provide specifics, but said Monday that treatment with ianalumab led to statistically significant improvements in disease activity compared to a placebo in each trial, as measured by a widely used index evaluating symptoms. The drug was also “well tolerated” and demonstrated “a favorable safety profile,” the company said in a statement. 
    • “Novartis will share the findings at an upcoming medical meeting and submit them to global health regulators.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Kaiser Permanente closed its second quarter of the year with a billion dollars of operating income and a $3.3 billion bottom line—but operating headwinds on the horizon have leadership taking a hard look at the health system’s cost structure and potential efficiencies.
    • “The quarter’s performance is a step ahead of last year, when the integrated nonprofit reported $908 million of operating income and $2.1 billion in net income.
    • “It’s also a fair jump in the scale of Kaiser’s operations. Consolidated operating revenues and expenses during the most recent quarter were $32.1 billion and $31.1 billion, respectively, up from $29.1 billion and $28.2 billion in the second quarter of 2024. These reflect a 3.2% operating margin in the second quarter of 2025 and a 3.1% operating margin in the second quarter of 2024.
    • “Together with the year’s opening quarter, Kaiser now sits at about $63.9 billion of operating revenue and nearly $2 billion of operating income for the first half of the year. Kaiser said its operating income runs highest during the beginning of the year due to the timing of its health plan’s open enrollment”
  • Healthcare Dive tells us,
    • “Major for-profit hospital chains reported lower-than-expected volumes in second quarter earnings results, causing some to cut back on volume and earnings expectations for the year.
    • “Executives at the for-profit hospital chains — HCA Healthcare, Tenet Healthcare, Community Health Systems and Universal Health Services — attributed the volumes to different factors, from lower Medicaid admissions to a decline in consumer confidence, which impacted spending on healthcare services. 
    • “Softer volumes caused HCA, Tenet and CHS to lower their full-year outlooks for admissions. UHS did not report expectations for volume growth.”
  • Here are links to Kaufmann Hall’s June 2025 flash reports on hospitals and physicians, both of which were released today.
  • Beckers Hospital Review points out CMS’s 290 five star and 229 one star hospitals.
    • “Every year, CMS assigns star ratings to U.S. hospitals based on 46 hospital quality measures, which are divided into five categories: mortality, safety, patient experience, readmission rates, and timely and effective care. Data reporting periods range from July 2020 to December 2024, depending on the measure. The ratings were updated in July and released Aug. 6.” “
  • The American Journal of Managed Care informs us,
    • “Prescribing semaglutide in routine clinical practice was associated with meaningful—but smaller than seen in clinical trials—improvements in cardiovascular risk factors, along with an unexpected rise in non-drug health care spending, according to a new study published in JAMA Network Open.1
    • “Analyzing data from more than 23,500 adult patients across Yale New Haven Health System and Sentara Healthcare, researchers found that patients experienced an average 3.8% reduction in body weight and significant reductions in blood pressure (–1.5 mm Hg for diastolic; –1.1 for systolic), total cholesterol (–12.8 mg/dL), and hemoglobin A1c (HbA1C) at 13 to 24 months following their first semaglutide prescription. However, during the same time period, monthly health care expenditures rose by $80 per patient, not including the cost of semaglutide itself.
    • “These findings highlight a disconnect between clinical benefits and short-term cost savings, warranting caution when extrapolating trial-based projections to clinical settings,” the researchers said.”

Monday report

David Ermer–CDC, Congress, FDA, Federal employment benefits, HIPAA Privacy and Security Rules, Medical / Rx research, Obesity, U.S. Healthcare–
  • Govexec tells us,
    • “Last week, Senate Homeland Security and Governmental Affairs Committee Chairman Rand Paul, R-Ky., unveiled his panel’s portion of congressional Republicans’ budget reconciliation package, which aims to reduce federal spending to partially pay for extended tax cuts for the ultrawealthy and increased immigration enforcement. The measure abandoned a series of House-passed proposals to cut the retirement benefits of currently serving federal workers but would have required future federal hires to pay nearly 15% of their paychecks toward their retirement benefits if they wished to accrue civil service protections.
    • “But Sen. Jeff Merkley, D-Ore., top Democrat on the Senate Budget Committee, announced Sunday that the Senate parliamentarian had ruled that most of the Senate’s proposals governing federal benefits and workforce policies violated the Byrd rule, which aims to limit reconciliation measure—and its simple majority threshold for passage—to topics that are budgetary in nature.” * * *
    • “Provisions that would require a 60-vote majority to advance include the plan to require all new federal employees to pay 9.4% toward the Federal Employees Retirement System and to choose between paying an additional 5 percentage points toward FERS or serving as at-will employees; a requirement that federal employees challenging an adverse action before the Merit Systems Protection Board pay a $350 filing fee, as well as a proposal to charge federal employee unions for use of agency property and official time on a quarterly basis.
    • “The parliamentarian also said that a provision effectively giving the Trump administration “carte blanche” to reorganize federal agencies and lay off thousands of federal workers would similarly run afoul of the Byrd rule. Earlier this month, Senate Majority Leader John Thune told reporters that he would not consider overruling the parliamentarian as part of the bid to send the reconciliation package to President Trump’s desk by July 4.
    • “Still remaining in the package is a provision tasking the Office of Personnel Management with conducting an audit of enrollees in the Federal Employees Health Benefits Program to ensure family members remain eligible as dependents, and a requirement that the government charge a 10% fee on deductions from federal workers paychecks, such as unions dues and charitable contributions as part of the Combined Federal Campaign.”
  • The American Hospital Association News informs us,
    • “The Department of Health and Human Services June 23 announced an initiative coordinated with multiple health insurance companies to streamline prior authorization processes for patients covered by Medicare Advantage, Medicaid managed care plans, Health Insurance Marketplace plans and commercial plans. Under the initiative, electronic prior authorization requests would become standardized by 2027. HHS stated that these reforms complement ongoing regulatory efforts by CMS to improve prior authorization, including building upon the Interoperability and Prior Authorization final rule. 
    • “The plan is expected to make the prior authorization process faster, more efficient and more transparent, the agency said. Participating insurers pledged to expand real-time responses by 2027. HHS said that the insurers would also commit to reducing the volume of medical services subject to prior authorization by 2026, including those for common procedures such as colonoscopies and cataract surgeries. 
    • “During a news conference, HHS Secretary Robert F. Kennedy Jr. said unlike previous attempts by insurers, this initiative would succeed because the number of insurers participating represent 257 million Americans. “The other difference is we have standards this time,” he said. “We have … deliverables. We have specificity on those deliverables, we have metrics, and we have deadlines, and we have oversight.” 
    • “Mehmet Oz, M.D., CMS administrator, said that the pledge “is an opportunity for industry to show itself.” Sen. Marshall, R-Kan., said that Congress could pursue codifying at least some portions of the initiative in the future. 
    • “Additionally, participating insurers would honor existing prior authorizations during coverage transitions.” 
  • Here are links to AHIP and BCBSA announcements concerning this prior authorization development.
  • Think Advisor points out,
    • “Most Medicare programs use current premium revenue and government contributions to pay for their operations.
    • “One Medicare program, the Medicare Part A inpatient hospitalization program, is supposed to use the earnings on assets stored in a trust fund to cover some costs.
    • “Assets at the trust fund have fallen below $209 billion — less than the asset total at UnitedHealth or CVS Health.
    • ‘Medicare trustees say they now expect the trust fund to run dry in 2033. That’s down from a depletion year of 2036 included in last year’s report.
    • “But if the Part A trust fund runs dry, and Congress makes no changes, payroll taxes and premium revenue should be high enough to cover about 89% of the promised inpatient hospitalization benefits, according to the trustees.
    • “The trustees’ estimate of the share of promised benefits ongoing revenue can pay is unchanged from last year.”
  • HHS lets us know,
    • “On June 18, 2025, [as the FEHBlog noted at the time] the U.S. District Court for the Northern District of Texas issued an order declaring unlawful and vacating most of the HIPAA Privacy Rule to Support Reproductive Health Care Privacy at 89 Federal Register 32976 (April 26, 2024).
    • “With regard to the modifications to the HIPAA Privacy Rule Notice of Privacy Practices (NPP) requirements at 45 CFR 164.520, the court vacated only the provisions that were deemed unlawful, namely 164.520(b)(1)(ii)(F), (G), and (H).
    • “The remaining modifications to the NPP requirements are undisturbed and remain in effect, see Carmen Purl, et al. v. U.S. Department of Health and Human Services, et al., No. 2:24-cv-00228-Z (N.D. Tex. June 18, 2025).
    • “Compliance with the remaining NPP modifications is required by February 16, 2026. HHS will determine next steps after a thorough review of the court’s decision.”
    • In the FEHBlog’s view, it’s a safe bet that HHS will not appeal this decision.
  • BioPharma Dive notes,
    • “A top Food and Drug Administration official responsible for overseeing drug reviews is reportedly retiring from the agency, adding to an exodus of senior staff who have either left or been forced out by Trump administration leadership.
    • “Jaqueline Corrigan-Curay, who serves as acting head of the FDA’s Center for Drug Evaluation and Research, will depart next month, according to reports from Endpoints News, Stat News and other publications.
    • “Corrigan-Curay became acting CDER director after Patrizia Cavazzoni left the position shortly before the Trump administration took office. A physician and lawyer, Corrigan-Curay joined the FDA in October 2016 and was appointed principal deputy center director at CDER in 2021.”
  • Bloomberg Law reports,
    • “Republican Senator Bill Cassidy is seeking to delay a scheduled meeting of vaccine advisers selected by Health and Human Services Secretary Robert F. Kennedy Jr. out of concern they’re not sufficiently qualified.
    • “Cassidy, who’s from Louisiana and leads the Senate’s health committee, publicly called on the Trump administration to put off the meeting slated for Wednesday via a post on the social platform X on Monday.
    • “Wednesday’s meeting should not proceed with a relatively small panel, and no CDC Director in place to approve the panel’s recommendations,” posted Cassidy.” * * *
    • “Cassidy will run the hearing for President Donald Trump’s CDC director nominee, Susan Monarez, on Wednesday. That’s the same day that the vaccine advisers are expected to begin their meeting. 
    • “Spokespeople for CDC and HHS did not immediately respond to requests for comment.”

From the public health and medical research front,

  • Health Day reports,
    • “Hypertension is the most common chronic condition among adults aged 85 years and older, with prevalence higher among women than men, according to a report published in the June Health E-Stats, a publication of the National Center for Health Statistics.
    • “Yelena Gorina, M.P.H., and Ellen A. Kramarow, Ph.D., from the National Center for Health Statistics in Hyattsville, Maryland, used data from the 2022 and 2023 National Health Interview Survey to present estimates of the percentage of adults aged 85 years and older with 11 selected chronic conditions.
    • “The number of American adults aged 85 years and older was 6.1 million in 2023 and is projected to reach 13.7 million by 2040. The authors note that the most common of the selected chronic conditions reported were hypertension, arthritis, and high cholesterol among civilian noninstitutionalized adults aged 85 years and older (66.9, 55.9, and 46.5 percent, respectively). For both men and women, hypertension was the most common chronic condition reported, with a higher prevalence for women than men (68.9 versus 63.7 percent). The prevalence of arthritis was also higher for women than men (63.2 versus 44.2 percent), but men had a higher prevalence of high cholesterol (50.5 versus 44.0 percent), cancer (39.8 versus 28.6 percent), heart disease (31.5 versus 26.3 percent), and diabetes (19.3 versus 14.5 percent).”
  • The American Medical Association tells us what doctors wish their patients knew about thyroid cancer.
  • Beckers Hospital Review lists by state the 514 U.S. hospitals 514 hospitals with “a catheter associated urinary tract infection rate of zero, as based on the healthcare-associated infections dataset from CMS.”
  • The New York Times reports at length on the impact of the measles outbreak on healthcare providers and public health officials in rural America.
  • Consumer Reports, writing in the Washington Post, discusses “using cannabis for health problems It’s being used for everything from pain to insomnia. When it might help and when it won’t — in any case, don’t vape or smoke it.”
  • FiercePharma relates,
    • “Roche has demonstrated the power of combining two of oncology’s hottest modalities—bispecifics and antibody-drug conjugates (ADCs)—in a Lunsumio-Polivy regimen in large B-cell lymphoma (LBCL).
    • “The combination of the CD20xCD3 bispecific Lunsumio and the CD79b-directed ADC Polivy significantly reduced the risk of progression or death by 59% versus the traditional R-GemOx regimen in patients with previously treated LBCL who are not eligible for stem cell transplant. R-GemOx includes Roche’s own Rituxan and the chemotherapies gemcitabine and oxaliplatin.
    • “Patients in the Lunsumio-Polivy group went a median 11.5 months without disease progression versus 3.8 months for R-GemOx, according to the primary analysis of the phase 3 Sunmo study presented at the International Conference on Malignant Lymphoma.
    • “Roche said it will submit the trial results to global health authorities, including the FDA. While Lunsumio is currently approved as an intravenous infusion to treat follicular lymphoma, the Sunmo trial uses a subcutaneous formulation of the drug. Polivy, meanwhile, received the FDA’s approval as part of a combination for certain previously untreated patients with LBCL in 2023.”
  • The Wall Street Journal reports,
    • “Novo Nordisk’s new weight-loss drug helped patients lose even more weight on average than its current Wegovy blockbuster treatment, an early-stage trial showed, as the drugmaker races to develop the next generation of obesity medicines.
    • “The company’s drug, known as amycretin, helped patients lose over 24% of their weight, which compares with an average of about 17% for its Wegovy treatment.
    • “The drug mimics the same gut hormone as the Wegovy treatment to suppress appetite, delay stomach emptying and control blood sugar, but combines it with amylin, a hormone in the pancreas that also regulates appetite.
    • “The new treatment was administered as a once-weekly shot and a daily pill, with results showing that side effects were mostly in line with other obesity medications. Patients taking the amycretin injection lost an average of 24.3% of their weight when dosing up to a 60-milligram shot over 36 weeks of treatment, while those on the pill lost up to 13.1% over 12 weeks.” * * *
    • “The data was published in the Lancet and presented at the American Diabetes Association conference over the weekend. Novo Nordisk plans a late-stage trial for the new drug early next year.”
  • STAT News also reports from the American Diabetes Association meeting,
    • “An investigational therapy from Eli Lilly helped preserve lean mass and drive greater loss of fat in patients taking the popular obesity treatment Wegovy.
    • “In a Phase 2 trial, patients taking the highest-dose combination of Wegovy and the drug, called bimagrumab, lost 22% of their weight at 72 weeks. Ninety-three percent of that was fat mass, and the rest was lean mass. People taking Wegovy alone lost a smaller 16% of their weight, and 72% of that was fat mass, according to results that will be presented Monday at the American Diabetes Association meeting.”
  • and
    • “Amgen’s monthly obesity candidate led to substantial weight loss but a high rate of side effects and discontinuations in a mid-stage trial, results that support the company’s decision to use a slower dosing schedule to make the drug more tolerable in further testing. 
    • “In the Phase 2 study, patients with obesity taking the injectable drug, called MariTide, lost up to 16.2% of their weight in one year when taking into account all participants regardless of discontinuations. Patients lost up to 19.9% when analyzing only those who stayed on treatment.”
  • and
    • “Obesity drugs were first approved to treat type 2 diabetes, but there’s a growing movement to test them in type 1 diabetes, too. Research presented Monday at a large diabetes meeting showed some promise for this approach.
    • “Patients who took a GLP-1 drug fared better than those in a control group at keeping their blood glucose levels in a healthy range while also losing more weight than those who weren’t taking the drug.”
  • Per BioPharma Dive,
    • “One of the most closely watched clinical trials in the burgeoning field of psychedelics research has delivered results that, while positive, appear to have unnerved some investors.
    • “Sponsored by U.K.-based biotechnology company Compass Pathways, the trial enrolled 258 people with treatment-resistant depression. Participants were given either a placebo or the company’s proprietary version of psilocybin — a psychedelic compound found in many mushroom species — and evaluated for an initial period of six weeks.
    • “According to Compass, a single dose of its drug significantly reduced scores on a 60-point scale that healthcare providers use to gauge depressive symptoms.”
    • The article explains why investors were not impressed by these results.

From the U.S. healthcare business front,

  • Fierce Healthcare discusses the top ten nonprofit health systems by 2024 operating revenue, and points out
    • “Despite an uncertain regulatory environment and higher hold period for investments in healthcare, deal volumes remain steady.
    • “So says a new report from PwC. In addition to regulatory scrutiny, persisting valuation gaps between buyers and sellers have contributed to hesitation in the market. Nonetheless, deals continue to pace significantly ahead of pre-COVID levels—though are down from the boom years of 2020 to 2022. The three-year running average of the number of healthcare transactions weighs in at 1,375. 
    • “The subsector leading with the most deals (454) in the last 12 months was a group of services that includes contract research organizations, ambulatory surgical centers, home infusion care and medical office buildings. These deals represented more than $31 billion in value. In second place were physician groups (413 deals totaling $11.3 billion) followed by labs and diagnostics (110 deals worth $7.6 billion).”
  • and
    • “Concern about the cost of GLP-1s remains high, and a new study suggests it’s not uncommon for patients to overpay for these drugs.
    • “E-prescribing company DoseSpot released a study Monday that analyzed more than 100,000 prescriptions for GLP-1s and found they likely overpaid by a collective $10.2 million. Most (92%) of prescriptions included at the study could have been obtained at a lower price.
    • “The data were provided exclusively to Fierce Healthcare. The report said that the $10.2 million in savings extrapolated across the approximately 32 million individuals who currently take GLP-1 ones mean there’s an opportunity here for potentially billions in savings.
    • “The bulk of the savings identified in the study, or about $7 million, would have been generated by being in one of the manufacturers’ savings programs. Josh Weiner, CEO of DoseSpot, told Fierce Healthcare in an interview that stakeholders can do more to keep providers in the loop about what patients may be eligible for.”
  • The Wall Street Journal reports,
    • “Novo Nordisk ended its partnership with Hims & Hers, accusing it of illegally selling copycats of Wegovy and deceptive marketing.
    • “Hims & Hers accused Novo Nordisk of pressuring it to steer patients to Wegovy, regardless of whether it was the best option.
    • “Hims & Hers’ shares dropped after the deal was scrapped. Novo Nordisk will continue to make Wegovy available via telehealth.”
  • Beckers Health IT takes a look at Google Healthcare’s moves.
  • Per Healthcare Dive,
    • “Ohio’s attorney general has conditionally approved venture capital firm General Catalyst’s acquisition of Summa Health, according to a press release Wednesday. 
    • “General Catalyst’s Health Assurance Transformation subsidiary, or HATCo, and the Akron, Ohio-based health system must meet 10 conditions to allow the deal to move forward, including increasing the purchase price by $15 million in cash and an additional $15 million in equity to the surviving nonprofit foundation, according to a letter sent by Attorney General Dave Yost’s office. The equity interest can’t be sold for three years. 
    • “HATCo will also have to file a yearly report with the attorney general to show it’s complying with post-closing obligations, as well as provide notice of new deals that could trigger antitrust concerns.”
  • Per MedTech Dive,
    • “Illumina said Monday it agreed to acquire SomaLogic and other assets from Standard BioTools for $350 million in cash to expand in the proteomics market.
    • “The deal includes additional near-term payments of up to $75 million tied to performance milestones, plus royalties.
    • “Illumina said the acquisition of SomaLogic, a leader in data-driven technology, will advance the company’s multiomics strategy and strengthen the value of its NovaSeq X products.
    • “Illumina and SomaLogic have partnered closely for more than three years, and this combination increases our ability to serve our customers and accelerate our technology roadmap towards advanced biomarker discovery and disease profiling,” Illumina CEO Jacob Thaysen said in a statement.”

Midweek Report

David Ermer–Congress, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, NIH, Obesity, Rx coverage, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

From Washington, DC

  • The American Hospital Association News tells us,
    • “A Congressional Budget Office report released June 4 found that enactment of the fiscal year 2025 budget reconciliation bill, the One Big Beautiful Bill Act (H.R. 1), would lead to 10.9 million people becoming uninsured in 2034 due to significant changes to the Medicaid program and Affordable Care Act coverage. A follow-up letter from the CBO provides more detail on how these changes would impact the number of uninsured. The CBO also estimated that the bill would lower gross benchmark premiums for marketplace plans under the ACA by an average of 12.2%.”
  • Per a Senate news release,
    • On Wednesday, June 11, 2025, at 10:15 am the Senate Judiciary Committee will hold a hearing titled “23 and You, the Privacy and National Security Implications of the 23 and Me Bankruptcy.”
  • STAT News reports,
    • In a boost for Merck, a U.S. Patent and Trademark Office panel agreed to reconsider a patent granted to another company that could affect plans to broaden use of its franchise product, the Keytruda cancer treatment.
    • “The dispute with Halozyme Therapeutics occurs as Merck plans to sell a new injectable version of Keytruda that the company is betting will sustain a medicine that has accounted for nearly half of its sales. Patent protection for the treatment, which is currently administered intravenously and generated $29.5 billion in revenue last year, lapses in 2028.
    • “At issue before the PTO are certain enzymes called Mdase that Halozyme developed to enable the administration of drugs by injection. Last November, Merck petitioned the PTO to reconsider seven patents that were awarded to Halozyme, arguing they were overly broad and should not have been granted. The filing came a few months after the PTO granted one patent in particular.
    • “Patent challenges are almost a daily feature of behind-the-scenes jockeying in the pharmaceutical industry, but the battle over Keytruda is more closely watched than most since the stakes are so high for Merck. In March, the company asked the Food and Drug Administration to approve the injectable version, which would cut treatment time in half, and a decision is expected in September.”
  • Per an HHS new release,
    • “The U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announces the appointment of Paula M. Stannard as Director of the Office for Civil Rights. In this role, Director Stannard is the Department’s chief officer and adviser to Secretary Robert F. Kennedy, Jr. concerning the implementation, compliance, and enforcement of Federal health information privacy, security, and breach notification rules under the Health Insurance Portability and Accountability Act (HIPAA) as well as Federal civil rights, conscience, and religious freedom laws in HHS’ jurisdiction.
    • “I’m proud to welcome Paula back to HHS,” said Secretary Robert F. Kennedy, Jr. “She’s a proven public servant who delivered results during her time at HHS under both President Trump and President George W. Bush. Paula brings deep institutional knowledge, relentless focus, and an unwavering commitment to civil rights. Under her leadership, the Office for Civil Rights will drive forward President Trump’s bold civil rights agenda with clarity, energy, and purpose.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “Moderna Inc. has agreed to do a placebo-controlled trial of its new Covid vaccine that was recently approved by US regulators, Health and Human Services Secretary Robert F. Kennedy Jr. said Tuesday.
    • “In a post on X, Kennedy said he wanted to “address those of you who have anxieties” about the Food and Drug Administration’s limited approval of Moderna’s vaccine, which was cleared for a narrower segment of the population than prior shots. 
    • “Moderna declined to comment. As a condition for approving the new shot, the FDA required a future placebo-controlled study in adults ages 50 to 64 without high-risk conditions, according to agency documents.
    • “Kennedy said that “the FDA will monitor and collect data throughout the trial for every adverse outcome” and “scrutinize every aspect of the trial.”
  • Per a press release,
    • Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—announced today FDA clearance of its most significant technological advancement to date. The clearance includes an entirely new portable MRI scanner powered by the proprietary Optive AI™ software. This new system delivers the highest level of image quality, functionality, and usability to date, unlocking a new brain imaging paradigm for clinicians and their patients.
  • Per FiercePharma,
    • “Bayer has taken another step toward achieving its €3 billion peak sales estimate for androgen receptor inhibitor Nubeqa, scoring an FDA approval to expand its use to all patients with metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC).
    • “The label expansion comes three years after the FDA signed off on Nubeqa in combination with androgen deprivation therapy (ADT) and the chemotherapy docetaxel to treat patients with mCSPC. The new nod allows Nubeqa to be used along with ADT by those who can’t tolerate chemo.
    • “The FDA endorsement was based on results of a phase 3 trial, ARANOTE, which showed that Nubeqa significantly extended the time before tumor progression or death in patients with mCSPC compared with ADT alone. In the study of 669 patients who were randomized 2 to 1 to receive 600 mg of Nubeqa plus ADT or placebo plus ADT, Nubeqa reduced the risk of radiographic progression or death (rPFS) by 46%, allowing the trial to achieve its primary endpoint.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration has awarded Sarepta Therapeutics a new kind of fast pass that could help speed the reviews of certain gene therapy applications it brings to the regulator in the future.
    • “The so-called platform technology designation issued to Sarepta is meant to streamline the development and evaluation process for gene therapies using a specific delivery tool, a viral vector dubbed rAAVrh74. That component is part of multiple Sarepta programs, among them the already approved Duchenne muscular dystrophy gene therapy Elevidys.
    • “According to Sarepta, the designation is one of the first given to a drug program since the initiative was launched by the FDA. It enables Sarepta to use evidence previously gathered from studies involving the vector in future applications, though differences in how some of its newer gene therapies are manufactured may limit its usefulness.”
  • Per MedTech Dive,
    • “Smiths Medical has recalled infusion pumps to update the instructions to address three problems that could lead to serious injury or death. The devices are staying on the market. 
    • “The Food and Drug Administration, which published Class I notices about the recalls Tuesday, said issues with some CADD-Solis Ambulatory Infusion Pumps and CADD-Solis VIP Ambulatory Infusion Pumps could interrupt or delay treatment. Smiths has not reported any serious injuries or deaths related to the issues, but the FDA sees a risk of harm.” 

From the public health and medical research front,

  • STAT News reports,
    • “KJ Muldoon, the first infant treated with a personalized gene-editing drug, has been discharged from the hospital for the first time in his life, the Children’s Hospital of Philadelphia announced Tuesday. After 307 days at CHOP, KJ was dressed in what early studies suggest are the world’s smallest and cutest graduation cap-and-gown before leaving.
    • “It’s a promising sign for KJ, his family, and the therapy researchers built in just 6 months. Born with an ultra-rare disease that prevented his liver from breaking down ammonia, he was rushed to CHOP, where specialists kept him under strict monitoring to prevent ammonia from flaring and doing long-term damage. Typically, he would receive a liver transplant. Instead, scientists across the country teamed to devise a gene-editing treatment.
    • “KJ received the first of three doses at six months old. He’s now 10 months old. The hope is that, while not cured, he has been left with a far more mild version of his disease. Meanwhile, researchers are working on ways to scale his treatment for thousands of others.”
  • and
    • “Circulating tumor DNA blood tests are rapidly gaining popularity among oncologists for their potential to detect cancer recurrence and treatment resistance earlier than traditional imaging. But despite their promise, data presented at the annual ASCO meeting this week suggest that the clinical value of ctDNA tests is still unproven.
    • “While some trials hint at benefits, others lack conclusive survival outcomes — which raises concern about whether early interventions based on ctDNA actually improve patients’ lives.
    • “We need evidence to know the true value of these tests,” University of Pennsylvania cancer researcher Angela DeMichelle told STAT’s Angus Chen. “They have incredible potential to help people, but if we don’t do the studies and don’t do them the right way, we can hurt people.”
  • The American Journal of Managed Care adds,
    • A blood-based circulating tumor DNA (ctDNA) test detected colorectal cancer (CRC) with 79.2% sensitivity and 91.5% specificity, according to a recent prospective study. These findings suggest the investigational test may be a viable noninvasive screening option, although its ability to detect advanced precancerous lesions remains limited.
    • The population-based, observational study is published in JAMA.
    • “This study was designed as a large, prospective diagnostic accuracy evaluation of a blood-based CRC screening test, with blinded comparison to colonoscopy in an average-risk screening population,” wrote the researchers of the study. “It enrolled a geographically and demographically diverse cohort across 201 sites, approximating the racial and ethnic distribution of the US.”
    • “CRC is the second leading cause of cancer-related deaths globally, with more than 1.9 million new cases and 930,000 deaths estimated in 2020 alone. Increased access to screening options—including stool-based tests, visual exams, and emerging blood-based tests—can help detect CRC at its most treatable stages and reduce both incidence and mortality.”
  • Per Reuters,
    • “American teens are increasingly turning to the weight-loss drug Wegovy as more families and their doctors gain confidence in its use for young people with obesity, new data shared with Reuters shows.
    • “The average rate of teens beginning treatment with the highly effective Novo Nordisk (NOVOb.CO), opens new tab drug grew 50% last year to 14.8 prescriptions per 100,000 adolescents, according to an analysis by health data firm Truveta.”
  • Per Healio,
    • “Enrollment in a patient-delivered intervention allowed adults with overweight or obesity to better maintain weight loss than those receiving standard of care, according to trial findings published in JAMA Internal Medicine.
    • “In the CHAMPS randomized controlled trial, adults with overweight or obesity who previously lost at least 5% of their body weight with lifestyle intervention were randomly assigned to a weight-loss maintenance intervention led by fellow patients who previously lost weight or to standard of care weight maintenance led by a physician. Adults participating in the patient-led intervention were more successful at maintaining their body weight.”
  • Medscape notes,
    • “As part of treating the overall well-being of your patients, it may be beneficial to recommend nutritional counseling. More insurance carriers are providing this service as a benefit.
    • “When patients have conditions such as type 2 diabetes, high blood pressure, heart disease or obesity, suggesting nutritional counseling could help your patients become more informed about making healthier choices. More health insurance plans cover nutritional counseling, although some may only provide coverage for specific conditions.
    • “Integrating nutritional counseling into routine clinical practice is essential and necessary to achieving optimal health outcomes,” said Scott Isaacs, MD, adjunct assistant professor of medicine, Emory University, and president of the American Association of Clinical Endocrinology, who is based in Atlanta. “By ensuring that nutritional counseling is accessible, personalized, and supported by insurance, we empower our patients to prevent disease, effectively manage chronic conditions, and improve both quality of live and longevity.”
  • The Wall Street Journal reports,
    • “New research is helping to answer an important question about ultra-processed foods: Which ones might be healthier? 
    • “One reason many ultra–processed foods often lead us to eat big meals and heavy snacks is because of their texture, which makes them go down easily and quickly, according to a new study presented this week at a conference in Orlando, Fla., of the American Society for Nutrition.
    • “But some diets filled with ultra-processed foods don’t cause us to eat as much. People in the study who had a diet of slower-to-eat ultra-processed foods such as crunchy breakfast cereal and multigrain buns consumed an average of 369 fewer calories a day than when they were eating quick-to-eat ultra-processed foods such as commercially made smoothies and soft breads.
    • “Meals that are equally satisfying were eaten in different ways purely as a function of the way they’re textured,” said Ciarán Forde, a professor at Wageningen University in the Netherlands, who led the study.”
  • Per an NIH press release,
    • Researchers at the National Institutes of Health (NIH) have identified which brain circuits are vital for visual acuity and how they are affected by damaged retinal cells. While vision restoration therapies, such as stem-cell and gene therapies, aim to replace or repair damaged cells in the eye, it is critical to understand how brain circuits involved in vision are affected by retinal cell loss. Study results suggest that targeting these circuits may be necessary to achieve optimal recovery of visual function, and have significant implications for the development of future vision restoration therapies that address visual pathways beyond the retina. The study published today in The Journal of Neuroscience.
    • “A huge amount of progress has been made in repairing the eye, however little attention has been paid to the functional consequences beyond the eye,” said the study’s lead investigator, Farran Briggs, Ph.D., senior investigator at NIH’s National Eye Institute (NEI). “Brain circuits downstream of damaged or dying retinal cells in the eye may also undergo some loss of function following changes to their retinal inputs.”

From the U.S. healthcare business front,

  • Beckers Health IT lets us know about six things concerning “CVS Health’s $20B bet on integrated, tech-enabled care,” and five details about Mark Cuban’s pharmacy network.
  • Modern Healthcare reports,
    • “Despite tight budgets and other operational challenges, health systems are increasingly investing in replacement hospitals and sustainability, while maintaining a strong focus on outpatient facilities in construction and design projects.
    • “More than 53% of the construction and design firms that responded to Modern Healthcare’s 2025 Construction and Design Survey said the industry is growing, even as it faces financial headwinds such as funding limitations, inflation and recent tariffs.”
  • Per BioPharma Dive,
    • “Looking to defend its giant cardiometabolic health franchise, Eli Lilly is licensing a technology from Swedish biotechnology firm Camurus that promises to produce longer-acting medications.
    • “Camurus’ FluidCrystal technology is designed to methodically release a therapeutic drug substance into the body over a period of days or months. After an injection, the solution interacts with bodily fluids to transform into a liquid crystalline gel. The gel holds the active ingredient and then slowly degrades, releasing medicine.
    • “The deal includes an unspecified upfront payment as part of an initial package that may be worth as much as $290 million, Camurus said Tuesday. That figure also includes payments for reaching certain development and regulatory milestones. Another $580 million could be available for meeting sales goals, along with mid-single digit royalties for successful products.”
  • BioPharma Dive summarizes its reporters’ takeaways from the ASCO conference which ended yesterday.
  • Fierce Healthcare relates,
    • “DispatchHealth and Medically Home closed their merger deal on Wednesday, combining the forces of at-home care and hospital-at-home leaders.   
    • “Operating under the DispatchHealth brand, the combined company will provide three core service lines. Its hospital-alternative care service, also called hospital at home, provides inpatient hospital-level care at home. The company also provides emergency-level care, when appropriate, to help patients avoid ED visits. 
    • “The merger was announced in mid-March. In the coming months, the company will integrate Medically Home’s technology platform and clinical command center for use nationwide, the company said.
    • “The two leadership teams have combined. Jennifer Webster will continue as the CEO of DispatchHealth. Graham Barnes, who took over as CEO of Medically Home in August 2024, is departing to pursue new opportunities. Pippa Shulman, D.O., has assumed the role of chief medical officer, according to a press release.”

Monday Report

David Ermer–CDC, CMS, Congress, HIPAA Privacy and Security Rules, Medical / Rx research, Obesity, SCOTUS, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Federal News Network reports,
    • “Postmaster General Louis DeJoy will leave the Postal Service’s top job by the end of the day Monday, after he announced plans to leave the agency last month.
    • “I have today informed the Postal Service Board of Governors that today will be my last day in this role,” DeJoy said in a statement.
    • “DeJoy announced last month he was preparing to step down as postmaster general and urged the USPS Board of Governors to begin the search for his successor.
    • “Deputy Postmaster General Doug Tulino will lead USPS until its Board of Governors selects a new postmaster general.”
  • The Wall Street Journal informs us,
    • “President Trump nominated the acting director of the Centers for Disease Control and Prevention to lead the agency permanently, after dropping his first pick for the job.  
    • “Susan Monarez was named acting director of the CDC early in the Trump administration and has worked closely with Health Secretary Robert F. Kennedy Jr.’s leadership team to fight a measles outbreak in Texas.
    • “Dr. Monarez will work closely with our GREAT Secretary of Health and Human Services, Robert Kennedy Jr. Together, they will prioritize Accountability, High Standards, and Disease Prevention to finally address the Chronic Disease Epidemic and, MAKE AMERICA HEALTHY AGAIN!” Trump wrote Monday on Truth Social.
    • “Monarez has a Ph.D. in microbiology and immunology from the University of Wisconsin-Madison and subsequently studied at Stanford University.
    • “She would be the first CDC director without a medical degree in more than 70 years. She must be confirmed by the Senate.”
  • The Wall Street Journal also seeks to explain how the Medicaid program works in charts.
  • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) announced the Committee will mark up the nomination of Dr. Mehmet Oz to be Centers for Medicare and Medicaid Services (CMS) Administrator during an executive session on Tuesday, March 25, at 9:30 AM.” 

From the judicial front,

  • The Wall Street Journal lets us know,
    • “The Justice Department asked the Supreme Court on Monday to block a judge’s order requiring it to reinstate more than 16,000 federal employees, as administration officials vow to seek the justices’ intervention in clearing away lower-court rulings that have slowed Trump policies. 
    • “Earlier this month, a federal district judge in San Francisco ordered the government to reinstate probationary employees fired at a half dozen agencies under the Trump administration’s fast-moving plan to shrink the federal government. U.S. District Judge William Alsup found that the administration had failed to comply with legal procedures required for the layoffs. 
    • “Alsup’s order, and a similar one from a federal judge in Maryland, require agencies to offer the employees their jobs back while litigation over the legality of the layoffs proceeds. 
    • “In her Supreme Court brief, acting Solicitor General Sarah Harris argues that the case should have been thrown out of court because it was filed by labor unions and other organizations rather than the terminated employees themselves. Federal law requires government employees to raise complaints through an internal process before going to court, Harris said.” 
  • Bloomberg Law tells us,
    • “A group of former Wells Fargo employees failed to prove the bank neglected its fiduciary duties over its health plan’s prescription drug costs because they could not prove concrete harm, a federal judge in Minnesota ruled Monday.
    • “The workers sued in July in the US District Court for the District of Minnesota, alleging the plan paid excessive administrative fees and prescription drug prices compared to other large employer plans. Wells Fargo & Co. also violated the Employee Retirement Income Security Act by allowing pharmacy benefit manager Express Scripts to keep drug manufacturer rebates instead of passing them back to the plan, the employees argued.
    • “The high-profile case is part of a wave of legal challenges to rising employer health plan costs, with workers suing employers and employers suing their benefit administrators. The lawsuits follow legislative and regulatory changes strengthening transparency and fiduciary requirements for insurers and employers—scrutiny that is expected to continue from lawmakers and the Trump administration.
    • “The court agreed with the plaintiffs “in theory” that they could be injured by Wells Fargo’s PBM contract. But the former employees ultimately failed to prove standing because the plan covers a broad range of drugs beyond those cited in the complaint, and because the plan picks up costs after the plaintiffs hit their deductibles, the court concluded.
    • “There are simply too many variables in how Plan participants’ contribution rates are calculated to make the inferential leaps necessary to elevate Plaintiffs’ allegations from merely speculative to plausible,” Judge David T. Schultz wrote in his order dismissing the case.”
    • FEHBlog note — Judge Laura M. Provinzino wrote the decision, not Judge Schultz.

From the public health and medical research front,

  • The AP relates,
    •  “Tuberculosis continued to rise again in the U.S. last year, reaching its highest levels in more than a dozen years. 
    • “More than 10,300 cases were reported last year, an 8% increase from 2023 and the highest since 2011, according to preliminary data posted this month by the Centers for Disease Control and Prevention. 
    • “Both the number of cases and the rate of infections rose. Rates were up among all age groups, and 34 states reported an increase. 
    • “CDC officials say the rise is the mainly due to international travel and migration. The vast majority of U.S. TB cases are diagnosed in people born in other countries. Other illnesses that weaken the immune system and allow latent TB infections to emerge may also be at play.”
  • NBC News reports,
    • “Cervical cancer is one of the most preventable cancers, although recent research suggests that the United States is backsliding in efforts to detect the disease early, when it is most curable.
    • “A new study shows that the percentage of women screened for cervical cancer fell from 47% in 2019 to 41% in 2023.
    • “Rural women are 25% more likely to be diagnosed and 42% more likely to die from cervical cancer than women who live in cities, a trend that likely reflects lower screening rates in less populated areas, according to the study, published in JAMA Network Open this month.” 
  • Consumer Reports, writing in the Washington Post, explains “How to find a home health aide. Having the right person can make caring for a loved one much easier. Here are tips for finding and affording the help.”
  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have developed eye drops that extend vision in animal models of a group of inherited diseases that lead to progressive vision loss in humans, known as retinitis pigmentosa. The eye drops contain a small fragment derived from a protein made by the body and found in the eye, known as pigment epithelium-derived factor (PEDF).  PEDF helps preserve cells in the eye’s retina. A report on the study is published in Communications Medicine.
    • “While not a cure, this study shows that PEDF-based eye drops can slow progression of a variety of degenerative retinal diseases in animals, including various types of retinitis pigmentosa and dry age-related macular degeneration (AMD),” said Patricia Becerra, Ph.D., chief of NIH’s Section on Protein Structure and Function at the National Eye Institute and senior author of the study. “Given these results, we’re excited to begin trials of these eye drops in people.”

From the healthcare business front,

  • The Wall Street Journal reports,
    • “Novo Nordisk agreed to pay up to $2 billion for the rights to a developmental weight-loss and obesity drug from Chinese pharmaceutical company the United Bio-Technology (Hengqin) Co., as it looks to boost its pipeline of next-generation drugs.
    • “Novo Nordisk, which earlier Monday lost its crown as Europe’s most valuable company, said it signed an exclusive global licensing deal for UBT251, a drug that targets three different hormones to treat obesity, type 2 diabetes, and other diseases.
    • “The Danish pharmaceutical company will pay $200 million up front and potential milestone payments of up to $1.8 billion, as well as tiered royalties.
    • “Novo Nordisk has exclusive rights to develop, manufacture, and commercialize UBT251 globally, excluding the Chinese mainland, Hong Kong, Macau and Taiwan.
    • “UBT251 differs from Novo Nordisk’s current portfolio as it takes a three-pronged approach to weight-loss and blood-sugar control. It combines a GLP-1–the same class of drugs as Novo Nordisk’s blockbuster Wegovy and Ozempic–with GIP to reduce appetite and blood sugar, and glucagon to prevent low blood-sugar levels.”
  • The Wall Street Journal adds,
    • 23andMe has filed for bankruptcy but assures customers that their genetic data will remain protected and managed in accordance with applicable laws.
    • Consumers can delete their 23andMe account data and destroy any stored genetic material by following the instructions provided in the article [and quoted below].
    • In the event of a bankruptcy sale, consumer data may be sold as part of the transaction, but protections may be in place to ensure responsible handling of sensitive information.
      • “Log in to your 23andMe account and go to the “Settings” section of your profile. Then scroll to a section labeled “23andMe Data” at the bottom of the page. Click “View” next to “23andMe Data.” You can download your genetic data if you want a copy for personal storage.
      • “After that, scroll to the “Delete Data” section and click “Permanently Delete Data.” You will receive an email from 23andMe. Follow the link in the data to confirm your deletion request. 
      • “Some customers who tried to delete their data Monday said they received error messages. Those trying to resolve the issue reported long customer service wait times. A company spokesman didn’t immediately respond to requests for comment.”
  • Fierce Healthcare fills us in one the latest Match Day for medical school seniors.
    • “Match Day 2025 has come and gone with the largest-ever total of applicants and positions as well as upticks in primary care and emergency medicine.
    • “The 73-year-old National Resident Matching Program’s (NRMP’s) breakdown of the annual event also outlined ongoing interest in obstetrics and gynecology—despite shifting reproductive care policies in the wake of the Dobbs decision—and a jump in participation among non-U.S. citizen international medical graduates.
    • “Applicants learned of their matches at 12:00 p.m. ET on Friday.
    • “All told, there were 52,498 total applicants, up 4.1% over last year, competing for 43,237 positions, up 4.2%.”

  • Beckers Payer Issues ranks payers by 2025 Part D membership
    • “Centene’s Medicare Part D enrollment is nearing 8 million members.
    • “According to CMS enrollment data from March 2025, Centene leads the nation in Medicare Part D membership with 7.92 million enrollees. The company has gained nearly 1 million members since the end of 2024, when its Part D enrollment was 6.93 million.”

Midweek Report

David Ermer–CDC, FDA, Generative AI, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, NIH, Obesity, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Per HHS press releases,
  • and
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the U.S. Department of Health and Human Services (HHS), today released updated National Behavioral Health Crisis Care Guidance (National Guidance), comprised of three documents: 2025 National Guidelines for a Behavioral Health Coordinated System of Crisis Care; Model Definitions for Behavioral Health Emergency, Crisis, and Crisis-Related Services; and a draft Mobile Crisis Team Services: An Implementation Toolkit, which is being released today for public comment. The updated National Guidance now reflects the national transition to the 988 Suicide & Crisis Lifeline in 2022 and other progress and emerging needs related to behavioral health crisis care and provides a framework for transforming behavioral health crisis care systems in communities throughout the United States, at a time when the U.S. continues to face record high rates of suicide and overdose.”
  • and
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with South Broward Hospital District d/b/a Memorial Healthcare System (Memorial Healthcare System), a Florida health system, concerning a potential violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The settlement resolves litigation resulting from an investigation about a complaint alleging a lack of timely access to an individual’s protected health information (PHI). The HIPAA Right of Access provisions require that individuals or their personal representatives receive timely access to their health information for a reasonable cost. OCR’s investigation determined that Memorial Healthcare System failed to provide timely access within 30 calendar days. Memorial Healthcare System has agreed to pay $60,000. The agreement marks OCR’s 52nd Right of Access enforcement action.”
  • The American Hospital Association News informs us,
    • “The Department of Health and Human Services and Drug Enforcement Administration published a series of rules Jan. 15 related to telemedicine prescribing of controlled substances, including a special registration proposed rule and a final rule on telemedicine prescribing of buprenorphine. 
    • “The proposed rule for special registration outlines three types of registration to waive in-person visit requirements prior to virtual prescribing of controlled substances and a state registration for every state in which a patient is treated by the special registrant. Providers would need to apply for the special registrations. The DEA also proposes that providers be required to review nationwide prescription drug monitoring programs after three years. Comments on the proposed rule are due March 15. 
    • “The DEA’s final rule for the telemedicine prescribing of buprenorphine will enable practitioners to prescribe a six-month initial supply of Schedule III-V medications to treat opioid use disorder via audio-only telemedicine interaction without a prior in-person evaluation. Practitioners can then prescribe additional medication via other telemedicine encounters (real-time, two-way audio-visual) or after an in-person encounter. The agency finalized a stipulation that providers will need to complete a review of the PDMP for the state where the patient is located. Requirements for the special registration proposed rule would not apply to clinicians prescribing buprenorphine for OUD.”
  • and
    • “The Centers for Medicare & Medicaid Services announced Jan. 15 that 53.4% of people with Traditional Medicare are in an accountable care relationship with a provider, a 4.3% increase from last year. The agency said it is the largest increase since it began tracking accountable care relationships. 
    • “For 2025, CMS approved 228 applications for the Medicare Shared Savings Program, bringing the total number of accountable care organizations participating in MSSP to 476. Approved applicants included 55 new ACOs and 173 renewing or reentering ACOs, the most in the program’s history.  
    • “CMS said there was also a 16% increase from last year in federally qualified health centers, rural health clinics and critical access hospitals participating in the MSSP. In addition, 103 ACOs are continuing participation in CMS’ ACO Realizing Equity, Access, and Community Health Model, and 78 kidney contracting entities and 15 CMS Kidney Care First Practices are continuing participation in the Kidney Care Choices Model.”  
  • The Census Bureau has partnered with the Department of Defense to track how veterans fare in labor market when they return to civilian life. Check out their report.

From the Food and Drug Administration front,

  • The Wall Street Journal reports
    • “Eli Lilly said it received Food and Drug Administration approval for its treatment for moderate to severely active Crohn’s disease, an inflammatory bowel disease that causes chronic abdominal pain.
    • “The treatment, developed by the pharmaceutical company under the brand name Omvoh, is now approved to treat two types of inflammatory bowel disease in the U.S., the Indianapolis company said Wednesday. The drug was previously approved to treat ulcerative colitis in adults in October 2023.
    • “Omvoh’s approval as a treatment for Crohn’s disease was based on results from a study in which 53% of patients treated with the drug achieved clinical remission, and 46% of patients had visible healing of the intestinal lining, at one year.”
  • and
    • The Food and Drug Administration is banning the use of Red No. 3, an artificial dye linked to cancer in animals, from food and ingested drugs.
    • The move will impact thousands of food products on the market in the U.S., including Betty Crocker’s loaded mashed potatoes and MorningStar Farms plant-based bacon strips. It is even in products that aren’t red, such as Brach’s candy corn. 
    • Food manufacturers will have until early 2027 to reformulate products that use Red 3. Consumer advocates pushed the agency to revoke authorization for the additive after two studies linked it to cancer in male laboratory rats. 
  • Roll Call adds,
    • “The Food and Drug Administration unveiled a proposal on Wednesday to limit the amount of nicotine allowed in cigarettes and some other combustible tobacco products, a final step for the agency before the Trump administration takes over next week.
    • The FDA first announced it would pursue regulatory changes to maximum nicotine levels in combustible smoking products in 2022 in an effort to reduce the public health effects related to addiction and minimize youth uptake.
    • “The agency is seeking public comment on the rule, but the proposal’s fate is unclear given the coming change in administration.”
  • STAT News described the last two FDA steps along with Tuesday’s proposal putting nutrition labels on the front of food packages as springing into Making America Healthy Again.

From the judicial front,

  • Beckers Payer Issues lets us know that insurer lawsuits over Medicare Advantage Star ratings are piling up.
  • STAT News relates,
    • “After years of sparring, the Biden administration and Gilead Sciences have settled a contentious lawsuit over patents for a pair of HIV prevention pills in a case that raised questions about the extent to which government-funded research should lead to affordably priced medicines.
    • “At issue was a battle over patents for Truvada and a newer, upgraded version called Descovy — two highly effective and lucrative medications — as well as the role played by the federal government in making it possible to prevent transmission of a highly infectious disease that plagued the American public for decades.
    • “The Centers for Disease Control and Prevention, which had funded academic research into HIV prevention that later formed the basis for the pills, maintained that Gilead infringed its patent rights. The U.S. Department of Health and Human Services also contended that the company had refused to reach a licensing agreement despite several attempts to strike a deal.
    • “Gilead, however, maintained it had invented the pills and that the concept of using Truvada to prevent HIV was well-known by the time the CDC tried to obtain its patents. The company also insisted it negotiated in good faith with the government. After a May 2023 trial, a jury sided with Gilead, finding it did not infringe on patents held by the CDC and, moreover, that those patents were invalid. The Biden administration, which sought $1 billion in royalties, subsequently appealed the decision.
    • “In a statement, the company said Wednesday that it will receive a license to “certain” current and future patents concerning HIV prevention that “will protect Gilead’s freedom to operate for years to come.” Any additional terms were not disclosed, although a Gilead spokeswoman wrote to say the settlement does not contain any payments from Gilead or the federal government.”

From the public health and medical research front,

  • The Hill reports,
    • “Respiratory illnesses are spreading throughout the U.S., causing multiple states to see a spike in hospital visits. The latest data shows another virus, known as HMPV, has also been spiking in some parts of the country. 
    • “The Centers for Disease Control and Prevention previously confirmed it was monitoring a spike in cases of HMPV, or human metapneumovirus, in China’s northern provinces. The agency noted the cases of the virus, which is not new, were not a “cause for concern in the U.S.” and that rates of infection nationwide are at typical “pre-pandemic” levels.
    • “HMPV is considered relatively common, with most infected before age 5, according to Dr. Eileen Schneider, an epidemiologist with the CDC. It often circulates during flu season and causes symptoms similar to the common cold, including coughing, wheezing, congestion and shortness of breath.” * * *
    • “Across Iowa, Kansas, Missouri and Nebraska, more than 5.8% of tests submitted for HMPV tested positive through the first week of the year, data shows. That’s more than double the positivity rate across the next-highest region — Alaska, Washington, Oregon and Idaho — which sits at around 2.7%.” * * *
    • “HMPV is typically diagnosed based on symptoms, the Cleveland Clinic explains, and not testing, unless you have serious symptoms.
    • “There are no vaccines or treatment therapies for HMPV, which makes preventing the spread of HMPV especially important. Health experts recommend washing your hands often and avoiding contact with those who are infected with HMPV if possible.”
  • Becker Hospital Review tells us,
    • “The latest data from the American Society of Health-System Pharmacists reports that the active number of drug shortages in the U.S. has decreased to 271, down from a high of 323 in the first quarter of 2024. However, despite this decline, ongoing challenges continue to burden healthcare providers.” 
  • and
    • “Eli Lilly expects its experimental weight loss pill, orforglipron, to receive approval as early as next year, CEO David Ricks told Bloomberg Jan. 13.
    • “The company is preparing to release key late-stage trial data on the drug by mid-2025. The weight loss pill aims to compete with popular injectable treatments like Eli Lilly’s own Zepbound and Novo Nordisk’s Wegovy, which currently dominate the space. 
    • “If approved, orforglipron would offer a pill alternative to the current injectables, making it easier for patients to use while also addressing manufacturing challenges. 
    • “In mid-stage trials, the drug helped patients lose up to 14.7% of body weight, compared to just 2.3% for those who took a placebo.”
  • The National Cancer Institute points out,
    • “For people with a history of smoking, a diagnosis of lung cancer can cause feelings of guilt and shame due to the stigma that’s often associated with the disease. This stigma can hinder open communication between patients and health care providers and hinder patients’ use of tobacco cessation counseling. Researchers at Memorial Sloan Kettering Cancer Center have developed a training program to help health care providers reduce lung cancer–related stigma. In this interview, the trial’s leaders, Smita Banerjee, Ph.D., a behavioral scientist, and Jamie Ostroff, Ph.D., a psychologist, discuss the impact of stigma on people with lung cancer and an NCI-supported clinical trial that’s evaluating the training program.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports “As deadly fires continue to rage in Los Angeles, healthcare companies far and wide are stepping up to serve those affected. At least 24 people have died from the fires, and dozens remain missing.” Bravo.  
  • STAT News notes,
    • “When Eli Lilly last year started offering lower-priced vials of its blockbuster obesity drug Zepbound, which were previously sold in injectable pens, it framed the move as a way to expand patient access. But some experts weren’t convinced, noting that Lilly was only offering the lowest doses in vials, and the new prices, $399 or $549 a month, are still prohibitive for many patients.
    • “CEO Dave Ricks said Lilly is now considering expanding the vial offering. “We’d like to lower the entry cost, and we’d like to have more doses available. That’s not something we’re announcing today, but we see that as an option,” he said Tuesday at a taping of ”The Readout LOUD,” STAT’s biotech podcast.”
  • Kaufmann Hall shares its “Winter 2025 Kaufman Hall Report: Highlights from the 2024 Healthcare Leadership Conference.”
  • Per Healthcare Dive,
    • “Teladoc Health is joining an Amazon marketplace that aims to connect consumers with health benefits programs, the telehealth vendor said Monday.
    • “Now, eligible users can find and enroll in Teladoc’s diabetes, hypertension, pre-diabetes and weight management programs through Amazon’s Benefits Connector.
    • “The program could help drive enrollment in Teladoc’s chronic care offerings, executives said at the J.P. Morgan Healthcare Conference in San Francisco on Monday. “I wouldn’t count on it bringing revenue for us very quickly, but it is certainly something that we will continue to pursue in terms of growing our chronic care program,” Teladoc CFO Mala Murthy said.”
  • Medical Economics explains why 2024 was a ‘blockbuster year’ for concierge medicine.
  • Fierce Pharma offers news from the third day of JP Morgan healthcare conference.
  • Healthcare Dive discusses top healthcare technology trends in 2025. The shape of AI regulation will be uncertain under the Trump administration this year, while healthcare companies will continue bolstering cyber defenses to withstand increasing attacks, experts say.

FEHBlog Extra

David Ermer–ACA, CMS, FDA, Federal employment benefits, HIPAA Privacy and Security Rules, HSA, OPM, U.S. Healthcare–

From Washington, DC,

  • Federal News Network reports,
    • “President-elect Donald Trump has announced plans to nominate a new leader for the Office of Personnel Management.
    • “On Sunday evening, Trump’s team shared in a press email that Scott Kupor, currently a managing partner at venture capital firm Andreessen Horowitz, is the planned pick for OPM director in Trump’s second term.
    • “Scott will bring much needed reform to our federal workforce,” Trump said in a statement on Sunday.
    • “Prior to his current role at Andreessen Horowitz, Kupor served as chairman of the National Venture Capital Association from 2014 to 2018, according to his LinkedIn profile. Kupor has also worked as vice president and general manager of technology company Hewlett-Packard (HP) and held various other executive management roles in the private sector. * * *
    • “Kupor graduated Phi Beta Kappa from Stanford University with a bachelor’s degree in public policy with honors and distinction. He also holds a law degree with distinction from Stanford University and is a member of the State Bar of California.”
  • and
    • “President Joe Biden has finalized a 2% federal pay raise for the General Schedule, but the increases federal employees across the country will see when they open their first paycheck of 2025 will look a little different.
    • “That’s because the 2% federal pay raise is an average — it will vary slightly depending on where federal employees work and their locality pay area.
    • “Biden’s 2% raise includes a 1.7% across-the-board boost that most civilian employees on the General Schedule will get, as well as an average of a 0.3% locality pay adjustment. The 0.3% portion of the raise accounts for the variations in next year’s federal pay raise. Starting in January, some feds’ raises will be slightly above the 2% average raise, while others will see slightly less than the average.
    • “For 2025, the spread of raises ranges from a high of 2.35% in the San Francisco-San Jose-Oakland locality pay area, and a low of 1.88% in the Cleveland locality pay area, according to the General Schedule pay tables the Office of Personnel Management published Monday afternoon. Federal employees working in the national capital region will get a 2.22% raise next year.”
  • Bloomberg reports,
    • “The Biden administration on Monday withdrew a proposed rule that, if finalized, would have expanded access to birth control coverage offered under the Affordable Care Act.
    • “The ACA guarantees coverage of women’s preventive services, like birth control and contraceptive counseling, at no cost for women enrolled in group health plans or individual health insurance coverage. In 2018, new regulations expanded exemptions for religious beliefs and moral convictions that allow private health plans and insurers to deny coverage of contraceptive services.
    • “The [February 2, 2023] proposal—from the departments of Health and Human Services (RIN: 0938-AU94), Labor (RIN: 1210-AC13), and Treasury (RIN: 1545-BQ35)—would have removed the moral exemption waiver, but retained the current religious exemption, the Centers for Medicare & Medicaid Services said previously.”

In judicial news,

  • Reuters lets us know,
    • “A federal judge in Texas ruled that Democratic President Joe Biden’s administration likely exceeded its authority by issuing a rule strengthening privacy protections for women seeking abortions and for patients who receive gender transition treatments.
    • “U.S. District Judge Matthew Kacsmaryk in Amarillo on Sunday [December 22] agreed to block the U.S. Department of Health and Human Services from enforcing the rule against a Texas doctor who through lawyers at a conservative Christian legal group challenged the regulation as unlawful.
    • “The ruling by Kacsmaryk, who was appointed by Republican President-elect Donald Trump in his first term, issued the preliminary injunction a day before a Monday deadline for the doctor, Carmen Purl and her business to comply with the rule.”
    • FEHBlog observation: As noted in the article, the preliminary injunction applies only to the plaintiff.

In Food and Drug Administration news,

  • Per an FDA press release,
    • “Today [December 23], the U.S. Food and Drug Administration approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise.
    • “The FDA approved the first generic in this class of medications last month with the approval of a generic referencing Byetta (exenatide).
    • “Liraglutide injection and certain other GLP-1 medications are currently in shortage. The FDA prioritizes assessment of generic drug applications for drugs in shortage to help improve patient access to these medications.
    • “The FDA supports development of complex generic drugs, such as GLP-1s, by funding research and informing industry through guidance as part of our ongoing efforts to increase access to needed medications,” said Iilun Murphy, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Generic drugs provide additional treatment options which are generally more affordable for patients. Today’s approval underscores the FDA’s continued commitment to advancing patient access to safe, effective and high-quality generic drug products.”
  • STAT News reports,
    • “The FDA just approved Alyftrek, a once-daily medicine for a small slice of cystic fibrosis patients that carry certain mutations, including F508del. It’s a triple combination CFTR modulator that works across 31 other mutations, and outperformed Trikafta — another popular Vertex drug for cystic fibrosis — in its ability to reduce sweat chloride levels. This is the company’s fifth CFTR modulator to win U.S. approval.
    • “Vertex said that the drug offers simpler dosing for existing patients taking its drugs — but will be beneficial for an additional 150 U.S. patients with the disease, whose mutations are now treatable.”
  • Per Fierce Pharma,
    • “Undeterred by last year’s rejection and the recent approval of a close rival from Pfizer, Novo Nordisk has pushed its once-daily hemophilia injection across the regulatory finish line days before we hit 2025. 
    • “Late last week, Novo revealed that the FDA approved its tissue factor pathway inhibitor (TFPI) antagonist concizumab as a once-a-day treatment to prevent or curb the frequency of bleeding episodes in patients ages 12 and older who have hemophilia A or B with inhibitors.
    • “The prophylactic, which comes in prefilled, premixed pens for subcutaneous injection, will be marketed under the commercial title Alhemo, Novo said in a release.”

From the public health and medical research front,

  • Beckers Clinical Leadership offer five updates on the respiratory illness surge and six developments on bird flu as we head into the new year.
  • The American Medical Association fills us in on what doctors wish their patients knew about pneumonia.
  • Consumer Reports, writing in the Washington Post, relates “Things to do, and not to do, when you have a cut. Don’t “air it out.” Put down the hydrogen peroxide. Don’t bother with the antibiotic ointment. But do wash it and cover it.”

From the U.S. healthcare business front

  • Per Fierce Healthcare,
    • “Despite significant headwinds coming to bear over the past several years, healthcare executives are expecting a favorable 2025, according to a new survey from Deloitte.
    • “Deloitte’s Center for Health Solutions polled 80 C-level leaders at healthcare organizations, including 40 from health systems and 40 from health plans. Close to 60% said they believe the outlook for the coming year is favorable, increasing from 52% in last year’s survey.
    • “A majority (69%) said they believe revenues will grow in 2025, and 71% said they expect greater profitability.
    • “Two major themes emerged from executives in both sectors, according to Deloitte: growth and consumer affordability. In addition, insurance executives said they were gearing up for a year of regulatory change and new technological advancements, while health system leaders said they expect continued workforce challenges and enhancements to core business technologies.
  • Bloomberg reports,
    • “Republicans have a new chance to expand health savings accounts offered by employer plans when Congress reconvenes in 2025, revisiting a divisive policy that some Democrats support even as others denounce it as a tax break for the wealthy.
    • “Health savings accounts let high-deductible health plan enrollees use tax-free dollars on certain medical expenses. The money rolls over annually and can be invested tax-free for higher returns. Twenty-two percent of employers surveyed by the Kaiser Family Foundation offered HSA-eligible plans in 2024.
    • “Advocates see the tax-advantaged accounts as a vehicle to increase both health care access and conscious spending for high-deductible plan members, who pay more out-of-pocket before insurance kicks in. Lawmakers from both parties have proposed bills to allow patients to use HSAs for everything from gym memberships and menstrual products to funeral expenses and veterinary bills.” * * *
    • “Labeling HSAs as tools for the wealthy is a “mischaracterization,” said Johns Hopkins University accounting and health policy professor Ge Bai, pointing to data that show the majority of HSA holders live in zip codes where the median income is below $100,000. Loosening requirements around the accounts could be particularly useful for gig workers who lack insurance, she said.”
  • Beckers Hospital Review shares Mark Cuban’s plans for the new year.

Tuesday Tidbits

David Ermer–AHRQ, CDC, CMS, Electronic health records, Federal employment benefits, HIPAA Privacy and Security Rules, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Healthcare Dive lets us know,
    • “President-elect Donald Trump has nominated Dr. Mehmet Oz, a physician, TV personality and former Republican candidate for Senate, to run Medicare and Medicaid as administrator for the CMS.
    • “America is facing a Healthcare Crisis, and there may be no Physician more qualified and capable than Dr. Oz to Make America Healthy Again,” Trump said in his announcement on social media platform Truth Social.
    • “The CMS oversees the healthcare coverage of more than 160 million Americans, or around half the U.S. population, through Medicare, Medicaid, the Children’s Health Insurance Program and Affordable Care Act plans.”
  • Per an HHS press release,
    • “Today, the Surgeon General released a new report on health disparities related to tobacco use, which finds that despite the nation’s substantial progress in reducing cigarette smoking and secondhand smoke exposure in the overall U.S. population, that progress has not been equal for all population groups. Disparities in tobacco use persist by race and ethnicity, income, education, sexual orientation and gender identity, occupation, geography, behavioral health status, and other factors. Additionally, cigarette smoking and secondhand smoke exposure continue to cause nearly half a million deaths a year in the United States—nearly one in five of all deaths.
    • “This report expands upon the 1998 Surgeon General’s report on tobacco use among U.S. racial and ethnic groups to include data and trends by additional demographic factors and their intersection. This report also summarizes research on factors that influence tobacco-related disparities, and outlines actions everyone can take to eliminate these disparities and advance health equity in the United States.” * * *
    • “For Surgeon General’s report information and resources, including the full report, a report executive summary, a consumer guide, and fact sheets, visit www.SurgeonGeneral.gov
      or www.CDC.gov/EndTobaccoDisparities“
  • FedManager offers its take on the ongoing Federal Employee Benefits Open Season while Serving Those Who Serve delves into Medicare Part D EGWPs participating in the FEHB and PSHB Programs.
  • HealthITBuzz reflects on a “Year of Movement in Pharmacy Interoperabiilty.” The more electronic health record interoperability, the better, after all.
  • The American Hospital Association News tells us,
    • Data released Nov. 18 by the University of Pennsylvania found that 15% of U.S. adults are familiar with the 988 Suicide and Crisis Lifeline, a 1% increase from last year. Those individuals from the survey reported that they knew the number and correctly stated it when asked in an open-ended format. One percent of respondents inaccurately reported the number was 911, an improvement from 4% in 2023. The 988 hotline launched in July 2022.”
    • The FEHBlog wonders if 911 operators transfer appropriate calls to 988 operators.
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), announced a $100,000 civil monetary penalty against Rio Hondo Community Mental Health Center (“Rio Hondo”) in California. The penalty resolves an investigation into Rio Hondo over a failure to provide a patient with timely access to their medical records. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule’s right of access provisions require that individuals or their personal representatives have timely access to their health information (within 30 days, with the possibility of one 30-day extension) and for a reasonable, cost-based fee. OCR enforces the HIPAA Privacy Rule, which establishes national standards to protect individuals’ medical records; sets limits and conditions on the uses and disclosures of protected health information; and gives individuals certain rights, including the right to timely access and to obtain a copy of their health records.” * * *
    • “The Notice of Final Determination may be found at: https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/rio-hondo/notice-final-determination/index.html“

From the public health and medical research front,

  • The New York Times reports,
    • “If I drew you a graph that showed the death rate among American kids, you would see a backward check mark: Fewer kids died over the last several decades, thanks to everything from leukemia drugs to bicycle helmets. Then, suddenly, came a reversal.
    • “I first noticed this in 2021 while poking around in mortality data from the virus-ridden year before. It looked bad. I knew that kids who contracted Covid tended to fare better than older people, but was the virus killing them, too?
    • “Nope. It wasn’t the virus. It was injuries — mostly from guns and drugs. From 2019 to 2021, the child death rate rose more steeply than it had in at least half a century. It stayed high after that. Despite all of the medical advances and public health gains, there are enough injuries [from firearms, traffic, drugs and drowning] to have changed the direction of the chart.”
  • Consumer Reports, writing in the Washington Post, informs us about “microplastics, phthalates, BPA and PFAS. We encounter these potentially toxic materials in everyday life. Here’s the difference among them.”
  • BioPharma Dive let us know,
    • “An experimental under-the-skin injection of Merck & Co.’s cancer immunotherapy Keytruda showed similar characteristics as the current intravenous formulation in a Phase 3 clinical trial, the company said Tuesday.
    • “The drugmaker plans to discuss data from the trial, which it didn’t disclose in full, with the Food and Drug Administration and other regulators. The intravenous form of Keytruda is expected to lose U.S. patent protection in 2028, which would open the door to biosimilar competitors.
    • “Rival Roche has already gained FDA approval for a subcutaneous version of its competing immunotherapy Tecentriq, while Bristol Myers Squibb is awaiting an FDA decision on an under-the-skin injection of Opdivo. Merck could be as much as a year or more away from approval of subcutaneous Keytruda.”
  • and
    • “An experimental pill developed by Johnson & Johnson and Protagonist Therapeutics significantly cleared skin in most people with moderate-to-severe plaque psoriasis who enrolled in a Phase 3 trial run by J&J.
    • “Treatment with the drug, called icotrokinra, led to clear or almost clear skin in about two-thirds of participants after four months of testing. Just under half experienced a 90% or greater reduction in their scores on another measure of psoriasis plaque coverage and severity. Only 8% and 4%, respectively, of study participants on placebo hit those same marks.
    • “Responses to icotrokinra improved further through six months and, according to a Monday statement from J&J, a similar percentage of participants in both trial groups experienced side effects. The company plans to present detailed results at an upcoming medical meeting.”
  • The National Institutes of Health offers information about “Weight-loss surgery in teens | Sugar intake and chronic disease risk | Mapping cancer formation and spread.”
  • Per an NIH press release,
    • “Experts convened by the National Institutes of Health (NIH) have identified five elements of a brain-based condition that has emerged as a leading cause of vision impairment starting in childhood in the United States and other industrialized nations. Known as cerebral (or cortical) visual impairment (CVI), some estimates suggest that at least 3% of primary school children exhibit CVI-related visual problems, which vary, but may include difficulty visually searching for an object or person or understanding a scene involving complex motion. Their report, based on evidence and expert opinion, was published today in Ophthalmology.
    • “Lack of awareness about CVI is a large factor leading to it to be misdiagnosed or undiagnosed, which can mean years of frustration for children and parents who are unaware of an underlying vision issue and don’t receive help for it,” said report co-author, Lotfi B. Merabet, O.D., Ph.D., associate professor of ophthalmology, Massachusetts Eye and Ear and Harvard Medical School, Boston.
    • “Clarifying the factors for suspecting CVI should help build awareness and help eye care providers identify children for further assessment so they can benefit from rehabilitation and accommodation strategies as early as possible,” said report co-author, Melinda Y. Chang, M.D., assistant professor of clinical ophthalmology at the University of Southern California, Los Angeles.”
  • The Institute for Clinical and Economic Review (ICER) announced,
    • ICER will assess the comparative clinical effectiveness and value of tolebrutinib (Sanofi) for the treatment of secondary progressive multiple sclerosis (SPMS).
    • The assessment will be publicly discussed during a meeting of the CTAF in June 2025, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • ICER’s website provides timelines of key posting dates and public comment periods for this assessment.
  • The U.S. Preventive Services Task Force opened a public comment period of its Grade A recommendation that all pregnant women undergo early screening for syphilis infection. This recommendation confirms an earlier decision made in 2018. The public comment period ends on December 23, 2024.

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “UnitedHealth Group’s Optum Rx, CVS Health’s Caremark and Cigna’s Express Scripts have sued the Federal Trade Commission alleging the agency’s in-house case over insulin prices is unconstitutional.
    • “The companies, the three largest pharmacy benefit managers by market share, are suing to block the administrative proceedings, according to a complaint filed Tuesday in the U.S. District Court for the Eastern District of Missouri. The PBMs’ associated group purchasing organizations Emisar Pharma Services, Zinc Health Services and Ascent Health Services, respectively, are also plaintiffs in the case.” * * *
    • “The PBMs allege the FTC’s claims — which they deny — involve private rights that should be heard in a federal court and allege the administrative proceeding violates their due process rights under the Fifth Amendment.”
  • and
    • “Change Healthcare’s vital clearinghouse platform has been restored after a cyberattack on the UnitedHealth Group subsidiary caused unprecedented billing and payment disruptions for providers nationwide, the company announced on its status webpage.
    • “This is a big step for the technology company after its systems were taken offline following a February ransomware attack that caused widespread disruptions throughout the healthcare system. Change Healthcare operates as the largest clearinghouse for billing and payments in the U.S., processing 15 billion transactions annually and managing about one-third of patient records.” 
  • and
    • “CVS Health is the first company to earn a Health Equity Accreditation from URAC.
    • “The independent nonprofit accrediting organization said CVS was the first to apply to the program, which started in 2023.” * * *
    • “CVS’ social determinants of health dashboard — aimed at helping identify individuals who are at risk of poor outcomes and refer them to community-based programs and screening options — contributed to its accreditation, URAC said. The company’s work in addressing health-related cost and access barriers played a role too, according to URAC.”
  • Fierce Healthcare adds,
    • “Mike Pykosz, the former CEO of Oak Street Health, will leave CVS Health as part of the company’s latest leadership shake-up.
    • “CVS announced Tuesday that Sree Chaguturu, M.D., will step into the role of president for healthcare delivery alongside his existing title as chief medical officer. In the announcement, CEO David Joyner said that Pykosz let the company’s top brass know “earlier in the year that he planned to move on from the company and we appreciate him helping to lead a smooth transition.”
    • “As CMO, Chaguturu oversees CVS’ medical affairs organization and is responsible for clinical quality, patient outcomes, addressing access gaps and managing health costs across the enterprise. He was also previously the chief medical officer at CVS’ Caremark pharmacy benefit manager.”
  • Fierce Pharma identifies the 2024’s Fiercest Women in Life Sciences. Kudos to them!
  • KFF brings us up to date on the national IV fluid shortage created by Hurricane Helene.
    • “[H]ospitals are facing seasonal strains on their already limited IV fluid resources, said Sam Elgawly, chief of resource stewardship at Inova, a health system in the Washington, D.C., area.
    • “We’ve been very aggressive in our conservation measures,” Elgawly said, stressing that he does not believe patient care has been compromised. He told KFF Health News that across the system IV fluid usage has dropped 55% since early October.
    • “Elgawly called the shortage a crisis that he expects to have to continue managing for some time. “We are going to operate under the assumption that this is going to be the way it is through the end of 2024 and have adopted our demand/conservation measures accordingly,” he said.”
  • MedTech Dive tells us,
    • “The Food and Drug Administration alerted healthcare providers Friday about the safety and supply of Getinge/Maquet vessel harvesting devices.
    • “The letter to providers describes issues with Getinge/Maquet VasoView Hemopro Endoscopic Vessel Harvesting (EVH) Systems. Getinge recalled the devices in September after receiving 18 complaints about Hemopro 1.5 devices in four months, including reports of 17 serious injuries.
    • “The FDA letter addresses the injury reports and warns the removal of Hemopro 1.5 may interrupt the supply of EVH devices. The devices are now on the FDA’s device shortage list.”