Monday report

HIPAA Privacy and Security Rules

Monday report

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

From Washington, DC,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Midweek update

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Friday report

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

Happy first day of Spring!!

From Washington, DC

  • Roll Call reports,
    • “Senators are sticking around Washington this weekend after a busy week on the Hill highlighted partisan divides, intraparty friction and growing tension between the two chambers. One thing is clear — everyone is ready for spring break.
    • “The Senate has largely been wrapped up in an extended debate on the GOP’s marquee voter ID legislation, dubbed the SAVE America Act. Debate on the bill began Tuesday and is anticipated to extend through the weekend, at least. 
    • “We’re in through this weekend,” Senate Majority Leader John Thune, R-S.D., said on Fox News on Friday morning. “There will be a vote on this bill. We will find out where everybody stands.” * * *
    • “After Senate appropriators of both parties held a face-to-face meeting Thursday with White House “border czar” Tom Homan — some of the first signs of progress in weeks — Thune set a deadline of next week for resolving the DHS funding standoff.”
  • Bloomberg Law relates,
    • “The Trump administration’s Medicare chief said the version of the program run by private insurers doesn’t do enough to control costs, raising questions about how much the US will pay companies in a crucial upcoming rate update.
    • “Chris Klomp, a top health official at the US Centers for Medicare and Medicaid Services, said the private Medicare Advantage program “does not sufficiently have control of costs,” in remarks at a STAT conference in New York on Thursday.”
  • STAT News adds,
    • “President Trump’s Medicare director said Thursday his team is considering a policy that would automatically enroll Medicare beneficiaries into Medicare Advantage plans, a controversial idea that was touted in the conservative Project 2025 policy blueprint. 
    • “Chris Klomp said the Centers for Medicare and Medicaid Services is mulling the feasibility of models that would either automatically enroll beneficiaries into the private form of Medicare or accountable care organizations, such as those that participate in the Medicare Shared Savings Program. Individuals could still opt into a different insurance arrangement. Right now, people who don’t make a choice are covered by traditional Medicare.
    • “Would either of those, in my view, be superior to a default enrollment into a fee-for-service arrangement, where there’s not this long-term, secular relationship between the beneficiary, the patient, and their provider? Yes,” Klomp said. 
    • “He made the comments in an interview with STAT reporter Mario Aguilar on the sidelines of STAT’s Breakthrough Summit East in New York.”
  • Health Affairs Forefront tells us,
    • “The only truly clear and formally stated goal of the MFN [most favored nation drug pricing] policies is to lower the prices that Americans pay for drugs. How can we begin to evaluate the extent and impact of this kind of change?
    • “It is notoriously difficult to know, precisely, what most Americans “pay” for drugs. We have a complicated system of confidential manufacturer rebates and arrangements with pharmacy benefit managers that often tie out-of-pocket payments to “list” prices that may or may not actually be paid by anyone. People far smarter than I have made careers of shedding light on the cost of drugs in the US, and ultimately, it will be up to them to track whether any person or entity ends up paying less for drugs (and for which drugs) than prior to the policies’ enactment. Until then, Observatory members are watching developments in a few key areas that could influence the reach of MFN policies in the US.
    • “First, they are watching the relationship of the MFN policies to the employer-based insurance market, which covers 160 million people, or more than 50 percent of those with health insurance in the US. To date, MFN policies have been announced for Medicare and Medicaid recipients and for individuals who purchase drugs out of pocket on TrumpRx. But even at discounted prices available through TrumpRx, many drugs will remain too costly for consumers unless they can use the insurance for which they already pay premiums.
    • “The reach of the new, “lower” prices will be limited if there isn’t a mechanism for those with employer-sponsored insurance to access those prices. Part of such “access” includes having purchases through TrumpRx (or other direct-to-consumer platforms) count toward the deductibles and out of pocket maximums that characterize private coverage. Without explicit mechanisms to enable this kind of accounting—or federal or state mandates to require it—the purchase of drugs at the MFN prices will likely be unappealing to more than half of the US population, significantly diluting the policies’ effectiveness and reach. Further, if employer-sponsored health plans cannot access the MFN prices, then those lower prices cannot be reflected in their overall premiums, which consistently rise far faster than both general inflation and wage growth with escalating pharmaceutical costs being an important contributor.”
  • and
    • “As reported by the Centers for Medicare and Medicaid Services (CMS) in supplemental tables and public use files, the volume of cases submitted into the [No Surprises Act Independent Dispute Resolution] IDR process continues to exceed all expectations and grew rapidly in the first six months of 2025. During that period, parties submitted 1.2 million new disputes to the IDR portal—more than double the volume of the first two quarters of 2024 when nearly 590,000 disputes were filed. This amounts to a total of 3.4 million disputes from 2022 through June 2025.
    • “And the number of disputes is only continuing to increase: Even more recent bi-monthly updates from CMS show that nearly 1.4 million cases were filed from July 2025 through December 2025. This has resulted in a whopping 4.8 million total cases through the end of 2025. As a reminder, federal officials expected approximately 17,000 disputes per year.” * * *
    • “Consistent with prior trends, providers continued to initiate (and win) the vast majority of disputes.” * * *
    • Four provider groups and provider representatives—mostly backed by private equity—initiated the majority of these disputes: HaloMD, Team Health, Radiology Partners, and SCP Health. HaloMD—a middleman organization that specializes in arbitration—initiated the most disputes, accounting for 17 percent of all disputes in the first quarter of 2025 and 22 percent of all disputes in the second quarter of 2025. For an organization that initiated a mere 1 percent of line-item claims in 2023, this is a rapid rise to prominence. The second most frequent initiator, Team Health, has long been a high-volume IDR participant and initiated 16 percent of all disputes in the first six months of 2025, a level that is consistent with prior years. Combined, the top four initiators accounted for more than half (56 percent) of disputes filed in the first two quarters of 2025.
    • Providers also won 88 percent of disputes—the highest provider win rate to date—as compared to 85 percent in 2024 and 81 percent in 2023. Radiology Partners prevailed most often, winning favorable IDR awards in 92 percent and 95 percent of its cases in the first two quarters of 2025, respectively. Team Health saw similar win rates of 94 percent across both quarters. HaloMD won slightly less often but still prevailed in 87 percent and 82 percent of its disputes in the first two quarters of 2025, respectively.
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Centers for Medicare & Medicaid Services (CMS) has finalized the Administrative Simplification; Adoption of Standards for Health Care Claims Attachments Transactions and Electronic Signatures Final Rule (CMS-0053-F).
    • “This groundbreaking final rule establishes the first-ever Health Insurance Portability and Accountability Act (HIPAA)-adopted standards for health care claims attachments, enabling the secure electronic exchange of health care claims-related supporting clinical documentation such as medical records, x-rays and imaging, clinical notes, telemedicine visit documentation and laboratory results.
    • “The rule also establishes requirements for electronic signatures to ensure health care claims attachment transactions are secure, authenticated, and compliant with federal standards.” * * *
    • “Health care providers and payers should begin preparing to implement the finalized standards. This final rule is effective on May 26, 2026. The compliance deadlines for all requirements in this rule are set for 24 months from the effective date of the final rule. Stakeholders are encouraged to review the rule and begin implementing the new standards promptly. The final rule can be viewed at: https://www.federalregister.gov/.” * * *
    • To view the final rule fact sheet, visit: https://www.cms.gov/newsroom/fact-sheets/administrative-simplification-adoption-standards-health-care-claims-attachments-transactions.
    • For more information, visit: https://www.cms.gov/priorities/key-initiatives/burden-reduction/administrative-simplification/hipaa/events-latest-news.
  • PCMA points out,
    • “The Pharmaceutical Care Management Association (PCMA) is urging the Labor Department to roll back a proposed rule aimed at boosting price transparency in pharmacy benefit management relationships now that Congress has passed industry reforms.”
  • Beckers Payer Issues informs us,
    • “Nine percent of people who had ACA Marketplace coverage in 2025 are now uninsured, with healthcare costs as a major reason many enrollees either switched Marketplace plans or dropped coverage, according to a KFF poll. 
    • “The KFF follow-up survey of Marketplace enrollees was conducted Feb. 12 to March 2 and included 1,117 U.S. adults who had Marketplace insurance in 2025. The sample was drawn entirely from respondents to KFF’s original 2025 Marketplace survey, which included 1,350 participants.”

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “The FDA issued a safety communication today warning of a potential increased risk of seizures tied to certain medications used to treat Parkinson’s disease.
    • “The agency will require manufacturers of carbidopa/levodopa products to update their labels with clearer warnings, to better inform patients and clinicians of this risk. The revised prescribing information will specify that these medications can cause vitamin B6 deficiency and vitamin B6 deficiency-associated seizures.
    • “The warning also instructs healthcare professionals to assess baseline vitamin B6 levels before initiating carbidopa/levodopa therapy and to monitor these levels periodically during treatment, supplementing with vitamin B6 as needed.”
  • MedTech Dive adds,
    • “Intuitive Surgical has recalled stapler reload cartridges after receiving reports of four serious injuries and one death.
    • “The Food and Drug Administration communicated the recall in an early alert Wednesday, one week after Intuitive asked customers to quarantine and return all affected and unused reloads.
    • “An Intuitive spokesperson said in an email to MedTech Dive that the company is still investigating the root cause of rare reports of incomplete staple lines when using the recalled 8 mm SureForm gray reload cartridges.”
  • Fierce Pharma relates,
    • “Rhythm Pharmaceuticals is switching up the tempo for its melanocortin-4 receptor (MC4R) agonist Imcivree. After its initial approval more than five years ago to treat certain patients with genetic-driven obesity, the drug is moving into a different and broader realm with an FDA nod for acquired hypothalamic obesity (HO). 
    • “Acquired HO, for which Imcivree is the first approved treatment, represents an “expanded thinking” on the weight-regulating MC4R pathway that Rhythm’s product targets, Chief Scientific Officer Alastair Garfield, Ph.D., explained in a recent interview with Fierce. 
    • “Until now, all of Imcivree’s approved uses have centered around specific genetic causes. HO, on the other hand, is a result of a hypothalamic injury such as a tumor or stroke that impairs the MC4R pathway and causes weight gain and insatiable hunger (hyperphagia).”
  • Per an FDA news release,
    • “As part of the U.S. Food and Drug Administration’s continuous quality improvement efforts, the agency today published a Federal Register Notice seeking public comment on the Commissioner’s National Priority Voucher pilot program. The agency also announced a public hearing on June 12, to allow stakeholders to present information and views about the program.
    • “The public hearing, consistent with 21 CFR § 15.1 et seq., will seek feedback about the program’s eligibility criteria, the voucher selection processes, sponsor responsibilities, pre-submission requirements, FDA review procedures, the role of the CNPV Review Council, and other aspects of program implementation.” * * *
    • “The June 12 public hearing will be held at the FDA’s White Oak Headquarters with both an in-person and virtual option for participation. The FDA panelists will include subject matter experts from the Office of the Commissioner, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Oncology Center of Excellence, as well as a presiding officer. Requests to speak are due by May 1. The FDA is also soliciting written comments until June 27. For more information about the hearing: https://www.fda.gov/news-events/commissioners-national-priority-voucher-cnpv-pilot-program-public-hearing-06122026.”

From the judicial front,

  • Fierce Healthcare reports,
    • “A federal judge has dealt a blow to the Trump administration’s push to restrict gender-affirming care for minors.
    • “Per the New York Times, Oregon [U.S.] District Court Judge Mustafa Kasubhai ruled Thursday that Department of Health and Human Services Secretary Robert F. Kennedy, Jr. overstepped his legal authority in issuing a declaration late last year that would bar hospitals from providing gender-affirming care to minors if they want to participate in Medicare and Medicaid.” * * *
    • “Restricting access to gender-affirming care for minors has been a key priority for the Trump administration, and NYT reports that legal experts believe Kasubhai’s decision will likely be appealed.”

From the public health, medical and Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. This unusual timing means that higher levels of RSV activity may continue into April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old. Seasonal influenza activity remains elevated nationally but is decreasing in most areas of the country. COVID-19 activity is decreasing in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is decreasing in most areas of the country.
    • “Influenza
      • “Overall seasonal influenza activity remains elevated nationally but is decreasing in most areas of the country. Influenza A activity continues to decrease while trends in influenza B activity vary by region.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. This unusual timing means that higher levels of RSV activity may continue into April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old.
    • Vaccination
      • “RSV is a leading cause of hospitalization among U.S. babies.
      • “To help keep babies safe from severe RSV, babies younger than 8 months of age should get protection in their first RSV season (which usually starts in the fall) in one of these ways:
        • “The pregnant mother gets the RSV vaccine during pregnancy, or
        • “The baby gets an RSV antibody (nirsevimab or clesrovimab) just before the start of the RSV season or soon after birth, if born during the season.
      • “A CDC report showed that these protections are working. During the 2024–25 RSV season, infant RSV hospitalization rates were reduced by up to half compared to rates during seasons before when RSV prevention products were available.
      • “Interim estimates for the 2025–26 seasonal influenza vaccine show getting the vaccine reduced the risk of flu-related doctor visits and hospitalizations, supporting CDC’s vaccination recommendations. For children and teenagers, the vaccine was 38%–41% effective at preventing doctor visits and 41% effective at avoiding hospitalizations for the flu. For adults aged 18 and older, it was 22%–34% effective at preventing doctor visits and 30% effective for preventing hospital stays. Read more here: MMWR.
      • “Talk to your doctor or trusted healthcare provider about what may be recommended for you and your family.”
  • The American Hospital Association News reports,
    • “The Centers for Disease Control and Prevention announced today that there are now 1,487 confirmed measles cases nationwide so far this year. The CDC said 5% of cases have been hospitalized, and no deaths have been reported. The vaccination status of 92% of cases is unvaccinated or unknown. The South Carolina measles outbreak, which began in October 2025 and is currently the largest outbreak of any state, is at 997 cases. Utah, which has the second-largest outbreak, is now at 443 cases.” 
  • Health Day points out,
    • “Psychedelic-assisted therapy (PAT) is no more effective than traditional antidepressants (TADs) for treatment of major depression, according to a review published online March 19 in JAMA Psychiatry.” 
  • Medscape explains how “New Nanoparticles Can Destroy Undruggable Cancer Proteins.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Current schizophrenia (SZ) medications treat symptoms such as hallucinations and delusions, but do little for cognitive symptoms, such as disorganized thinking or executive dysfunction. As a result, many patients are unable to work, rely on family for lifelong support, become homeless or, in some cases, experience suicidal thoughts and actions.
    • “A study in humans and mice, headed by a team at Northwestern University, has discovered a novel biomarker of schizophrenia that could also serve as a new drug candidate to treat cognitive symptoms of the disorder. Their research in a mouse model of schizophrenia showed that treatment with a synthetic protein, SEAD1, corrected overexcited brain circuits. “A lot of people with schizophrenia cannot integrate well into society because of these cognitive deficits,” said Peter Penzes, PhD, professor of neuroscience, pharmacology and psychiatry and behavioral sciences at Northwestern University Feinberg School of Medicine. “Our discovery could solve these challenges by establishing the basis of a revolutionary and completely novel treatment strategy through a tandem biomarker-peptide therapeutic approach.”

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

  • BioPharma Dive reports,
    • “Novartis will pay $2 billion up front to acquire a drug that could improve upon existing treatments for patients with a particular form of breast cancer.
    • “Through a deal announced Friday, Novartis will purchase Pikavation Therapeutics, a subsidiary of privately held, Delaware-based Synnovation Therapeutics. The buyout hands Novartis an experimental pill called SNV4818, which targets tumors driven to growth by mutations to the PIK3CA gene. Alterations to this gene are implicated in a wide variety of cancers, including an estimated 40% of patients whose breast tumors are hormone-receptor positive, but don’t express the protein HER2, according to Novartis.”
  • Healthcare Innovation relates,
    • “Mary Bacaj, president of value-based care at Conifer Health Solutions, recently spoke with Healthcare Innovation about misconceptions around preventive care. She argues [in the interview found in the article] that self-insured employers should take a multi-year approach to assessing ROI rather than taking a single-year snapshot.” Check it out.
  • Beckers Hospital Review identifies and discusses six healthcare systems which are innovating primary care models to expand care.
  • Kaufman Hall informs us,
    • “Healthcare bankruptcy filings decreased for a second consecutive year, according to a recent report from Gibbons Advisors. The report finds a 21% decline in bankruptcy filings year-over-year, with the bulk of the 45 filings in 2025 occurring in the first quarter. The bankruptcy activity appears to be tempering, adjusting to pre-pandemic trends. By sector, senior care and pharmaceuticals comprise about half of the bankruptcies, with hospitals only accounting for 13.6% of all healthcare bankruptcy filings in 2025.”
  • The Withum CPA and consulting firm delves into “Artificial Intelligence and the Rise of Duplicate Claims: What Plan Sponsors Should Understand.”
    • “Artificial intelligence is fundamentally changing how healthcare claims are generated, submitted, and processed. As these technologies mature, both claim volume and complexity are likely to increase, placing additional pressure on traditional payment-integrity controls.
    • “While duplicate and near-duplicate claims are a visible result of this shift, AI also affects other aspects of the payment-integrity lifecycle, including coding accuracy, claim edits, resubmission behavior, and post-payment recovery.
    • “For plan sponsors, the question is no longer whether AI will influence claims administration, but whether current oversight frameworks have evolved to address these broader changes. Understanding duplicate-claim risk, evaluating vendor controls across the payment-integrity continuum, and ensuring transparency are increasingly important for prudent fiduciary governance in an AI-driven claims environment.
    • “As AI continues to reshape healthcare billing and claims processing, plan sponsors should periodically reassess whether their oversight frameworks and vendor controls remain aligned with an increasingly automated claims environment.”

Tuesday Report

David Ermer–Congress, FDA, Federal employment benefits, HIPAA Privacy and Security Rules, HSA, Medical / Rx research, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports.
    • “The Congressional Budget Office last week put out an “are you sitting down?” report that projected the U.S. government will spend $1 trillion on interest payments for its debt this year. One. Trillion. Dollars. To finance its gigantic and growing debt. And it will only get worse from there.
    • “It also projected that the U.S. government will spend $1.853 trillion more than it brings in through revenue this year (that’s the budget deficit) and have an even wider gap in 2027. Talks of slashing spending and making difficult choices last year have given way to election-year spending-increase promises in 2026. Perhaps complicating matters more, DOGE never really caught on in 2025, and Republicans seem reluctant to repeat that experiment any time soon.
    • “Budget angst tends to come in waves, but the debt never stops growing. I wrote about the $13.7 trillion debt here in 2010. That was $25 trillion ago.”
  • and
    • “The [Homeland Security Department] shutdown enters Day 4, with little chance of an end in sight after Congress failed to reach a deal on immigration-enforcement policies.”
  • Federal News Network reminds us about the bipartisan federal employment bills brewing in Congress.
  • Last Friday, the HHS Office for Civil Rights posted model HIPAA notices of privacy practices that were update for the Part 2 changes.
  • Navia Benefits lets us know,
    • “Health Savings Accounts (HSAs) have traditionally been viewed as a tax-advantaged way to pay for out-of-pocket medical expenses. But today’s data tells a much bigger story: they can function as a powerful financial wellness tool.
    • “HSAs are increasingly operating like powerful long-term investment vehicles rather than just spending accounts. Yet misconceptions persist across the workforce, and employee education continues to lag. With rising healthcare costs and growing financial pressures, it is a good time to elevate the HSA conversation.
    • [Navia’s article] examines the triple tax advantages, workforce perception trends, and evidence-based insights to guide employers in maximizing HSA participation and value.

From the Food and Drug Administration front,

  • Per a Senate news release,
    • :U.S. Senator Bill Cassidy, M.D. (R-LA), chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a landmark report detailing legislative and regulatory reforms to modernize the Food and Drug Administration (FDA). These proposals aim to maintain American biomedical dominance and ensure patients have timely access to the latest lifesaving treatments. The HELP Committee’s recommendations are directly in line with President Trump’s mission to improve the health of American children and families.
  • Fierce Pharma tells us,
    • “Harmony Biosciences is rounding out the U.S. patient pool eligible for its sleep disorder pill Wakix after notching a pediatric nod from the FDA that positions the drug as a treatment for cataplexy in people ages 6 and older with narcolepsy.
    • “The new addition to Wakix’s label makes it the only non-scheduled treatment for both adult and pediatric narcolepsy patients in the U.S. with or without cataplexy. That non-scheduled classification represents an “important distinction that supports its clinical utility,” Harmony’s CEO, Jeffrey Dayno, M.D., commented in a press release. Cataplexy is a common symptom of narcolepsy that involves a sudden weakening of muscles, often when triggered by a strong emotion.”
  • and
    • “Two months after Johnson & Johnson’s Rybrevant Faspro picked up its first FDA approval, the subcutaneous lung cancer drug has scored a label expansion to be given monthly.
    • “On Tuesday, J&J touted a “simplified” monthly dosing regimen for the drug’s combination with lazertinib for the first-line treatment of epidermal growth factor receptor EGFR-mutated advanced non-small cell lung cancer. Previously, the combo was approvedas an every-two-week regimen.
    • “For weeks 1 through 4, patients must still receive weekly doses of Rybrevant Faspro. Beginning week 5, the doses can shift to monthly administration.”

From the judicial front,

  • The Wall Street Journal reports,
    • “Bayer BAYN is making a new multibillion-dollar push to resolve a years long legal nightmare over Roundup weedkiller.
    • “The German pharmaceutical and agriculture conglomerate on Tuesday said it proposed to settle a nationwide class-action lawsuit to resolve claims that its flagship herbicide causes cancer. The settlement plan includes setting aside more than $7 billion to fund payments over 21 years. 
    • “Law firms representing tens of thousands of plaintiffs filed a motion Tuesday seeking approval of the settlement. The proposal requires court approval in Missouri, where the bulk of Roundup cases are outstanding.” 

From the public health and medical / Rx research front,

  • Patient Care reports,
    • “New data from the 2026 Primary Care Scorecard highlight measurable associations between regular primary care access and improved outcomes for patients with chronic disease.
    • “In the interview, Morgan McDonald, MD, National Director for Population Health at the Milbank Memorial Fund and practicing primary care internist and pediatrician, outlined key findings relevant to frontline clinicians.
    • “Among adults with chronic disease, having a usual source of care was associated with:
      • 20% lower hospitalization rates
      • 54% lower total cost of care
    • “For children with chronic disease, reductions in emergency department visits and hospitalizations for ambulatory care–sensitive conditions—such as pneumonia and otitis media—were “cut roughly in half.”
    • “The report also reinforces primary care’s role in prevention. Nearly all adults with a usual source of care received preventive services for conditions such as cardiovascular disease and common cancers, compared with approximately two-thirds of adults without a regular source of care. Similar trends were observed in pediatric populations, including higher receipt of counseling related to nutrition, exercise, injury prevention, and obesity prevention.”
  • Infectious Disease Advisor tells us,
    • “Low rates of diagnostic testing for respiratory syncytial virus in adult outpatient settings may result in an underestimated disease burden, potentially impeding the effective use of novel vaccines and therapeutic interventions.” 
  • MedPage Today informs us,
    • “Health systems where most pregnant patients have a high or moderate risk for preeclampsia may benefit from universal dispensation of aspirin, results from a large cohort study suggested.
    • “The rate of preeclampsia with severe features at a Texas health system was a relative 29% lower after it implemented universal aspirin dispensation in prenatal care compared with the period when aspirin was not recommended, regardless of risk factors (5.2% vs 7.1%; OR 0.71, 0.66-0.78, P<0.001), Elaine Duryea, MD, of University of Texas Southwestern Medical Center in Dallas, reported here.”
  • Medscape points out the top ten triggers for pancreatic cancer which is “an often silent disease.”
  • STAT News reports,
    • “Compass Pathways on Tuesday disclosed results from two Phase 3 studies that support a potential approval of its psilocybin treatment for severe depression, but more detailed data are needed to determine how beneficial the drug would be for patients.
    • “In both trials, patients who received the company’s psychedelic medicine saw greater improvements on a measure of depression than the control group, Compass said in a press release. Its drug, called COMP360, could be the first psilocybin product on the market and the second psychedelic approved after Johnson & Johnson’s Spravato, a ketamine derivative.
    • “Taken together, the data “probably meets the bar for approval. It doesn’t shout out to you that this is miraculous,” said Jerry Rosenbaum, director of Massachusetts General Hospital’s Center for Neuroscience of Psychedelics, who was not involved with the study.”
  • and
    • Ocular Therapeutix said Tuesday that its experimental treatment, called Axpaxli, maintained vision with less frequent injections compared to a standard treatment for patients with a common cause of age-related blindness — achieving the primary goal of a late-stage clinical trial. 
    • “However, the difference in the durability of treatment between Axpaxli and the active control in the study was narrower than investors expected — a finding that may spark debate about Axpaxli’s commercial potential in wet age-related macular degeneration, where effective drugs are already approved.”
  • Fierce Pharma adds,
    • “Continuing the reinvention of its cancer drug Gazyva as a treatment for immune-mediated diseases of the kidney—which resulted in a lupus nephritis nod last fall—Roche is touting new data that could tee up the antibody for a world-first approval.
    • “In an early look at results from the late-stage Majesty study in adults with primary membranous nephropathy, Gazyva (obinutuzumab) helped significantly more patients achieve complete remission at the two-year mark compared with the immunosuppressant tacrolimus, Roche said in a Feb. 16 press release. 
    • “Gazyva’s performance enabled the trial to hit its primary endpoint, and key secondary endpoints further pointed to statistically significant and clinically meaningful outcomes on overall remission at Week 104 and complete remission at Week 76 of the study, the company said.” 
  • Genetic Engineering and BioTechnology News relates,
    • “Researchers headed by a team at the University of California, Irvine, Joe C. Wen School of Population & Public Health have built what they suggest is the first cell type-specific gene regulatory network (GRN) map for Alzheimer’s disease (AD), which shows how genes causally regulate one another across different types of brain cells affected by AD.
    • “The researchers developed a machine learning framework, SIGNET (Statistical Inference on Gene Regulatory Networks), which reveals cause-and-effect relationships rather than simple genetic correlations, and applied this to uncover key biological pathways that may drive memory loss and brain degeneration. Their results pointed to numerous influential “hub genes” that offer promising potential new targets for early detection and therapeutic intervention. The investigators say their methodology is also applicable to other complex diseases, including cancer.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Ongoing headwinds caused by elevated utilization and medical costs continued to drag major health plans in the fourth quarter, completing the story of a complex 2025 for the industry.
    • “The most profitable company for the full-year was UnitedHealth Group, with $12.05 billion in earnings for 2025. The healthcare giant had a sizable lead on the next-highest payer in terms of profitability, which was Cigna at just below $6 billion.
    • “However, the company posted just $10 million in profit for Q4, the lowest tally among payers that turned a profit in the quarter. In Q4, the company saw a medical loss ratio of 92.4%, which settled to 89.1% for the full year.”
  • Fierce Healthcare adds,
    • “CommonSpirit Health’s adjusted operating margin inched into the black during the three months ended Dec. 31 as the organization’s leadership touted “noticeable” quarter-to-quarter performance gains stemming from strong volumes and efficiency. 
    • “The 138-hospital Catholic nonprofit posted a $78 million operating loss (-0.8% operating margin) for the second quarter of its 2026 fiscal year; however, after normalizing for delayed income received through California’s provider fee program, the system reached a narrow operating income of $2 million (0.0% operating margin). 
    • “CommonSpirit also reported $456 million excess revenues over expenses after normalizing. A year prior and after adjustment, the organization had an operating income of $135 million (1.3% operating margin) and a $356 million bottom line, which it noted was bolstered by around $352 million of Federal Emergency Management Agency grant revenue.”
  • Per Beckers Hospital Review,
    • “Ontario, Calif.-based Prime Healthcare’s nonprofit public charity, Prime Healthcare Foundation, acquired Lewiston-based Central Maine Healthcare on Feb. 16.
    • “The foundation received Maine’s approval to acquire Central Maine Healthcare in late November after sharing plans to acquire it in January 2025. 
    • “The transaction comprises Lewiston-based Central Maine Medical Center, Bridgton (Maine) Hospital, Rumford Hospital, Rumford (Maine) Community Home, Auburn, Maine-based Bolster Heights Residential Care, Lewiston-based Maine College of Health Professions, Lewiston-based CMH Cancer Care Center, and more than 40 physician practices, according to a Feb. 16 news release.
    • “The Prime Healthcare Foundation comprises 21 hospitals across the U.S. following the acquisition, with more than $4 billion provided in charity care.” 
  • and
    • “Marshfield Medical Center-Wisconsin Rapids Campus will open to patients March 1.
    • “The campus includes the soon-to-open hospital and Marshfield Clinic Wisconsin Rapids Center, according to a Feb. 16 health system news release.
    • “The hospital will include inpatient beds, an emergency department, exam and procedure rooms, radiological services that include general x-ray, computed tomography and ultrasound, and on-site laboratory testing.”
  • and
    • “Telehealth company eMed has partnered with CVS Caremark to offer a GLP-1 benefit model that lets employers subsidize weight loss medications without covering the full cost, Axios reported Feb. 16. 
    • “The arrangement allows eligible employees to purchase GLP-1s online through eMed and receive weight management services including side effect management, weekly check-ins and blood testing. Employers can decide how much of the cost to subsidize, the report said.” 
  • Per Healthcare Dive,
    • “Amwell is projecting lower revenue in 2026 after the health technology firm divested assets, executives said during an earnings call Thursday. 
    • “The firm expects revenue from $195 million to $205 million this year. In comparison, the telehealth vendor and health tech firm brought in revenue of $249.3 million in 2025.
    • “The top line for 2026 is smaller, but it’s “primarily high-quality, high-upside, sticky revenue,” CEO Ido Schoenberg said on the call.”
  • Per MedTech Dive,
    • “Danaher said Tuesday it has agreed to acquire patient monitoring company Masimo for $9.9 billion to bolster its diagnostics franchise.
    • “Masimo will become a standalone business unit and brand within Danaher’s diagnostics portfolio, operating autonomously while strengthening Danaher’s offering in acute care settings, the companies said.
    • “Masimo’s advanced sensor technology and AI-enabled monitoring bring powerful new capabilities to our diagnostics portfolio,” Julie Sawyer Montgomery, Danaher’s executive vice president for diagnostics, said in a statement.
    • “The $180-per-share cash deal has been unanimously approved by both Masimo’s and Danaher’s boards, according to Masimo.”

Tuesday report

David Ermer–ACA, HIPAA Privacy and Security Rules, Medical / Rx research, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Govexec identifies the five biggest stories for federal agencies and employees to watch in 2026.
    • 1.) Renewed shutdown watch
    • 2.) Return of RIFs? 
    • 3.) The implementation of ‘Schedule F’ and other changes to the civil service
    • 4.) Agency reorganizations
    • 5.) Court battles 
  • Beckers Payer Issues informs us,
    • “More than 15.6 million people have enrolled in plans on federally run ACA exchanges so far, down from about 16 million at the same point last year, CMS Administrator Mehmet Oz, MD, said Dec. 23.
    • “Dr. Oz attributed the decline to efforts to address fraudulent enrollments, writing on X: “Notably, this small drop follows several important CMS actions over the past year to combat fraudulent and improper enrollments, which have already removed more than enough people from premium subsidies who are covered elsewhere to account for the modest enrollment change. That said, there is a politically motivated lawsuit that has paused critical actions to make sure Biden-era improper enrollments are fully knocked out.”
    • ‘Earlier in the open enrollment period, ACA enrollment was outpacing last year. CMS data published Dec. 5 showed nearly 5.8 million plan selections through late November, up about 7% year over year, though new consumer enrollment was down 4% as returning consumers drove the gains.”
  • According to a Competitive Enterprise Institute news release,
    • “A new Competitive Enterprise Institute (CEI) study explores a thriving pharmaceutical delivery system that offers consumers real choice and convenience. Independent pharmacies are doing well and still make up a sizable portion of retail pharmacies. At the same time, new approaches like mail-order pharmacies and combined telehealth and pharmacy offerings are making it easier and cheaper than ever for patients to obtain necessary medications. And these new innovative approaches are providing access to rural areas that lack physical pharmacies.
    • “Invaluable to this well-functioning system is the role of pharmacy benefit managers (PBMs). PBMs own and manage most mail-order pharmacies, negotiating drug prices and running an efficient distribution network. PBMs provide convenient, reliable drug delivery to patients, making it easier for patients to stick to their treatment plan.
    • “But some lawmakers at the state and federal levels fear that PBMs wield too much influence over products and services, and they want to ban PBMs from owning pharmacies, whether mail-order services or retail stores like CVS. Perhaps they have not considered that in some rural counties, the only pharmacy available would be in danger of closing under these laws—potentially leaving residents in those areas with no local options.
    • “There is little evidence to suggest that worries about PBM-owned pharmacies are justified, and consumers are already protected from anticompetitive practices by existing laws.
    • “Banning successful business models doesn’t protect consumers; it protects competitors from competition,” said study author and CEI senior fellow Jeremy Nighohossian. “When it comes to building a system that works better for consumers, the free market is the best medicine.”
  • Modern Healthcare reports,
    • “The Drug Enforcement Administration on Tuesday temporarily extended a rule allowing clinicians to prescribe controlled medications remotely through the end of 2026.
    • “The rule, which will take effect Thursday, gives clinicians the ability to remotely prescribe Schedule II-V controlled medications to patients. This latest extension marks the fourth time the rule has been renewed since it was implemented at the beginning of the COVID-19 pandemic.
    • “Under the rule, clinicians are able to prescribe controlled medications, such as Adderall and Xanax via telemedicine appointments, without an initial in-person examination. The rule was originally set to expire at the end of December.”
  • The Holland and Knight law firm lets us know,
    • “Recent changes to the HIPAA Privacy Rule require that healthcare providers update their Notice of Privacy Practices (“NPP”) by February 16, 2026. The changes are intended to align HIPAA with the revised regulations governing substance use disorder records in 42 CFR part 2 (“Part 2”). A redlined version of 45 CFR 164.520 showing the changes to the rule is available here here.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Influenza cases are rising sharply, heightening fears that a new strain will fuel a punishing flu season that is already outpacing last year’s.
    • “The flu has sickened an estimated 7.5 million people so far this season, according to weekly data from the Centers for Disease Control and Prevention released Tuesday. About 81,000 people have been hospitalized and 3,100 have died so far this flu season, the agency estimated, including eight children. That reflects a sharp increase from the week prior, in which the CDC estimated about 4.6 million cases, 49,000 hospitalizations and 1,900 deaths. 
    • “Roughly 25% of samples sent to clinical laboratories came back positive for the flu in the week ended Dec. 20, the CDC said. That is up from about 15% the week before. 
    • “The figures raised concerns of a particularly harsh flu season this winter. The contagious respiratory illness typically kills thousands of people in the U.S. each year, though that number can rise significantly in years with troublesome viral variants.” 
  • The University of Minnesota’s CIDRAP tells us,
    • “Measles cases nationwide have reached 2,012, the Centers for Disease Control and Prevention (CDC) reported last week, as outbreaks in Arizona and South Carolina continue to grow and three other states alert the public about airport exposures.
    • “The US total reflects 54 new cases, as the country teeters on the brink of losing its measles elimination status—which it earned in 2000—next month. This year’s total is the nation’s highest since 1992, when officials reported 2,200 cases. Coordinated vaccination efforts led to a precipitous drop in cases in the ensuing decades, but vaccine skepticism in recent years has spawned the disease’s resurgence.”
  • and
    • “Relative to uninfected control patients, those hospitalized with acute respiratory infections (ARIs) due to respiratory syncytial virus (RSV) or influenza were at substantially higher adjusted risk for all-cause death, heart attack, exacerbation of asthma and chronic obstructive pulmonary disease (COPD), and hospitalization for heart failure, researchers from vaccine maker GSK and the Analysis Group report.
    • “The retrospective study, published last week in Clinical Infectious Diseases, used claims data from October 2015 to June 2023 to compare clinical outcomes among US adults aged 50 and older hospitalized for RSV or flu with those of controls without ARI. The average ages in the RSV and flu cohorts were higher than those of controls (76.5 and 75.4 vs 69.5 years, respectively).
    • “Current evidence on longer-term RSV-ARI outcomes among adults aged ≥50 years is limited, with insufficient research comparing the impact of RSV-ARI hospitalization to an appropriate comparator population representing the long-term health outcomes these patients would have experienced without severe RSV disease,” the study authors wrote.”
  • The New York Times relates,
    • “Rarely does a single study change the course of gynecological history. But a clinical trial published this year in The New England Journal of Medicine did just that, seeming to close the door on one of the great enigmas of women’s health.
    • “Bacterial vaginosis, or B.V., is the most common vaginal infection worldwide. If you have a vagina, there’s a one-in-three chance you will have B.V. at some point in your life.
    • “For years, doctors have known that the bacteria associated with the condition could also be found on the penis. Yet on paper B.V. was just a vagina problem — it’s right there in the name, vaginosis. For 50 years, gynecology treated it as if it were solely a women’s issue, with ineffective treatments that left women vulnerable to re-infection.
    • “The New England Journal study changed that. The researchers followed 150 heterosexual couples in which the female partner had bacterial vaginosis. They treated the women with first-line antibiotics, and half the men with both oral and topical antibiotics. Within three months, they found, the partner treatment worked so well that they had to disband the study so all participants could be treated.”
  • Medscape points out,
    • “Rates of gestational diabetes (GD) in the US rose every year from 2016 to 2024, with a total 36% jump in that 9-year period, new data showed.
    • “The data, from nearly all first live singleton births recorded in the National Center for Health Statistics, also showed that GD rose among all racial and ethnic groups, but with significant differences among them.
    • “The dramatic GD rise “likely reflects several factors including increasing prevalence of prepregnancy overweight and obesity, older maternal age at first birth, and higher rates of metabolic risk factors entering pregnancy. The COVID-19 pandemic may have further contributed to these trends through disruptions in routine preventive care, reduced physical activity, increased psychosocial stress, and weight gain during the pandemic period,” study first author Emily L. Lam, medical student at Northwestern University, Chicago, told Medscape Medical News.”

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

  • Fierce Healthcare reports,
    • “Brooklyn, New York-based Maimonides Health is merging with New York City’s public health system NYC Health + Hospitals, the organizations announced Dec. 29.
    • “The merger is pending final legal and regulatory approval but is expected to be finalized by April, city officials said.
    • “The partnership is supported by $2.2 billion over five years from New York state to protect safety net healthcare in Brooklyn, officials said.”
    • “Maimonides Health is a Brooklyn healthcare system with three hospitals and more than 80 community-based sites. By partnering with the city, Maimonides will be reimbursed at a higher rate by Medicaid, bolstering its financial position, health system executives said in a press release. 
    • “The merger also allows Maimonides to adopt a new Epic electronic health record platform. Health system executives said the move to Epic would help improve care coordination and the organization’s ability to collect revenue. Maimonides patients will be able to access their health records online and contact their care team digitally through the portal.”
  • Per Beckers Health IT,
    • “Healthcare organizations are increasingly adopting artificial intelligence to improve efficiency and reduce administrative burden, but most remain cautious about deploying AI in high-risk clinical scenarios, a Dec. 29 KLAS Research report found.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, Employee Wellness Programs, FDA, Generative AI, HIPAA Privacy and Security Rules, Medical / Rx research, OPM, U.S. Healthcare, Wellness–

From Washington, DC,

  • The Washington Post reports,
    • “House Republicans unveiled a new health care proposal Friday as they aim to address concerns about rising health insurance costs just weeks before enhanced Affordable Care Act subsidies expire.
    • “The legislation would codify and expand health plans for small businesses, fund reductions of premiums for low-income people in the individual health insurance market and increase transparency in prescription drug pricing, according to House Republican leadership aides.
    • “The proposal would also allow for a separate vote on an extension of the premium ACA tax credits, which subsidize health insurance for most of the 24 million Americans who buy their coverage from the Obamacare Marketplace — the central demand Democrats and moderate Republicans have made in the recent health care debate.
    • “The House is expected to vote on the proposal next week before leaving Washington for a two-week holiday break. If passed, it is unclear if the proposal could succeed in the Senate, where it would require 60 votes to overcome a filibuster.”
  • FEHBlog observation — This week, the Democrat leadship in the Senate offered a three year extension extension of the Biden subsidies while the Republican leadership offered a new approach with no transistion period. Both offerings were doomed to fail. The FEHBlog hopes that cooler heads prevail over the next week.
  • Govexec relates,
    • “The House voted 231-195 on Thursday to pass legislation that would nullify President Trump’s efforts to strip more than 1 million federal workers of their collective bargaining rights, sending the measure over to the Senate, where its prospects are less rosy.
    • “Twenty Republican lawmakers broke ranks to support the Protect America’s Workforce Act (H.R. 2550) on the floor. Introduced by Reps. Jared Golden, D-Maine, and Brian Fitzpatrick, R-Pa., the measure effectively nullifies Trump’s March executive order barring unions at more than 40 federal agencies under the guise of national security and bars federal agencies from terminating any union contracts that were in place prior to the edict’s signature.”
  • The American Hospital Association News lets us know,
    • “The Centers for Medicare & Medicaid Services Dec. 11 announced the launch of the Make America Healthy Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence Model, a voluntary payment model that will fund up to 30 chronic disease prevention and health promotion proposals. The proposals must include evidence-based functional or lifestyle medicine interventions not covered by Original Medicare. Under the MAHA ELEVATE Model, CMS said it will evaluate necessary data on the cost and quality of such interventions to inform future decisions on the feasibility of including them in Original Medicare. The agency will release a funding notice in early 2026 for the first cohort, which will begin Sept. 1, 2026. The second cohort will begin one year later.”
  • The U.S. Office of Personnel Management announced today that it is seeking public comments on its plan to resurrect its FEHB and now also PSHB health claims data warehouse.
    • “OPM is collecting service use and cost data from FEHB and PSHB Carriers, including medical claims, pharmacy claims, encounter data, and provider data. This data will enable OPM to oversee health benefits programs and ensure they provide competitive, quality, and affordable plans. OPM requires Carriers to report necessary information and permit audits and examinations to manage the FEHB Program effectively. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule permits covered entities, including carriers, to disclose protected health information (PHI), including service use and cost data, to health oversight agencies, such as OPM, for oversight activities authorized under 45 CFR 165.512(d)(1).”
    • This is a legally flawed analysis. The FEHB Act, 5 U.S.C. Sec. 8910(b), states
      • “(b) Each contract entered into under section 8902 of this title shall contain provisions requiring carriers to—
      • “(1) furnish such reasonable reports as the Office determines to be necessary to enable it to carry out its functions under this chapter; and
      • “(2) permit the Office and representatives of the Government Accountability Office to examine records of the carriers as may be necessary to carry out the purposes of this chapter.”
    • Furnishing all claims data to OPM is a not a reasonable report in any sense of the English language, and the HIPAA Privacy Rule does not give health oversight agencies new data access rights. See Fed. Reg. 82,462, 82,528 (Dec. 28, 2000). OPM should head back to the drawing board for consultations with carriers.
    • The public comment deadline is February 10, 2026.
  • On a related note, per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is pleased to announce the 2026 CMS Burden Reduction Conference taking place February 25, 2026, from 9:00 a.m. to 1:00 p.m. ET. This year’s conference will be a hybrid event, with in-person programming at the Hubert H. Humphrey (HHH) Building in Washington, DC, and a fully supported virtual option for remote attendees. In-person attendance will be limited due to space.”
  • OPM should hold a similar event for overburdened FEHB and PSHB carriers.

From the Food and Drug Adminstration front,

  • Per Fierce Pharma,
    • “Amid a swell of regulatory successes in the myasthenia gravis arena this decade, Amgen is wading into the fray with a new indication for its monoclonal antibody Uplizna.
    • “Thursday, the FDA greenlighted Uplizna (inebilizumab) to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. After two loading doses, Uplizna for gMG is administered just twice a year, Amgen noted in a Dec. 11 press release.”
  • and
    • “After a three-decade drought of new antibiotics to treat gonorrhea, the FDA has signed off on two first-in-class oral treatments for the sexually transmitted infection (STI), which affects more than 80 million people around the world each year. 
    • “On Friday, the U.S. regulator green lit Innoviva’s Nuzolvence (zoliflodacin) for uncomplicated urogenital gonorrhea. The nod comes less than 24 hours after the agency granted an approval in the same indication to GSK’s Blujepa, which was already on the market for uncomplicated urinary tract infections following its approval in March.
    • “The endorsements are similar in that both therapies are indicated for those ages 12 and older where standard of care treatment is contraindicated or where patients are intolerant or unwilling to use the first line of treatment.”
  • Cardiovascular Business tells us,
    • “The U.S. Food and Drug Administration (FDA) has granted 510(k) market clearance to the enVast mechanical thrombectomy system from Texas-based Vesalio.
    • “The company said the system offers a new approach to clot capture and the removal of large thrombus burden (LTB) in patients undergoing primary percutaneous coronary intervention (PCI). Thrombectomy is used in the coronary arteries to quickly remove clots to restore blood flow following a heart attack to minimizing myocardial damage.
    • “With FDA clearance and the upcoming U.S. launch of enVast, we are proud to introduce a device that we truly believe redefines coronary thrombectomy,” Steve Rybka, CEO of Vesalio, said in a statement. “Clinical experience internationally has consistently demonstrated its safety and effectiveness in managing complex LTB situations.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old. Seasonal influenza activity continues to increase in most areas of the country. COVID-19 activity is low nationally.
    • “COVID-19
      • “COVID-19 activity is low nationally.
    • “Influenza
    • “RSV
      • “RSV activity is increasing in the Southeastern, Southern, and Mid-Atlantic areas of the country with emergency department visits and hospitalizations increasing among children 0-4 years old.
    • “Vaccination
      • “It is not too late to get vaccinated ahead of the holidays. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The American Hospital Association News adds,
    • “The Centers for Disease Control and Prevention Dec. 11 released a report that found last year’s version of the COVID-19 vaccine was 76% effective in preventing emergency department or urgent care visits for children ages 9 months to 4 years. It was 56% effective for those ages 5-17 years old. “These findings suggest that vaccination with a 2024–2025 COVID-19 vaccine dose provided children with additional protection against COVID-19–associated ED/UC encounters compared with no 2024–2025 dose,” the CDC wrote.”
  • The New York Times reports,
    • “To treat their pain, anxiety and sleep problems, millions of Americans turn to cannabis, which is now legal in 40 states for medical use. But a new review of 15 years of research concludes that the evidence of its benefits is often weak or inconclusive, and that nearly 30 percent of medical cannabis patients meet criteria for cannabis use disorder.
    • “The evidence does not support the use of cannabis or cannabinoids at this point for most of the indications that folks are using it for,” said Dr. Michael Hsu, an addiction psychiatrist and clinical instructor at the University of California, Los Angeles, and the lead author of the review, which was published last month in the medical journal JAMA. (Cannabis refers to the entire plant; cannabinoids are its many compounds.)”
  • The AP informs us,
    • “The U.S. suicide rate dropped slightly last year from some of the highest levels ever reported, preliminary data suggests. Experts say it’s hard to know exactly why, or whether the decline will continue.
    • “A little over 48,800 suicide deaths were reported in 2024, according to provisional data from the Centers for Disease Control and Prevention, roughly 500 fewer than the year before.
    • “The overall suicide rate fell to 13.7 per 100,000 people.”
  • The Washington Post relates,
    • “Solving a technical challenge that has stymied science for 40 years, researchers have built a robot with an onboard computer, sensors and a motor, the whole assembly less than 1 millimeter in size — smaller than a grain of salt.
    • “The feat, accomplished by a partnership of researchers at the University of Pennsylvania and University of Michigan, advances medicine toward a future that might see tiny robots sent into the human body to rewire damaged nerves, deliver medicines to precise areas, and determine the health of a patient’s cells without surgery.”
  • Per Healio,
    • “GLP-1 receptor agonists are not associated with increased risks for dry age-related macular degeneration or cataract development, according to two recently published studies.
    • “The data instead showed significantly reduced risk for cataracts, as well as lower risk for dry AMD, linked with the use of GLP-1s, according to Abhimanyu Ahuja, MD, an ophthalmology resident at the Oregon Health & Science University Casey Eye Institute, and colleagues.
    • “Other studies have demonstrated that these medications have anti-inflammatory and neuroprotective properties,” Ahuja told Healio. “We wondered whether they might influence the risk of conditions like macular degeneration or cataracts in older adults.”
  • Per MedTech Dive,
    • “AtriCure, whose devices are used to treat atrial fibrillation and related conditions, said Thursday the first procedures were performed in patients with its new dual energy platform.
    • “The system integrates pulsed field ablation with a radiofrequency ablation approach using the company’s cardiac clamp technology. Surgeons can use either method independently or in combination.
    • “The platform is not yet approved for use in any market. AtriCure said it expects to initiate a clinical trial in the coming year.”
  • Per Biopharma Dive,
    • “Arcus Biosciences will terminate work on a TIGIT-targeting cancer drug following a decision to cancel a Phase 3 trial because it didn’t appear likely to improve patients’ survival, the company said in a statement Friday.
    • “Called domvanalimab, the drug was being tested in combination with the immunotherapy zimberelimab and chemotherapy against Bristol Myers Squibb’s Opdivo and chemo in gastric and esophageal cancers that haven’t been treated before. Arcus said an independent data committee recommended ending the trial because the domvanalimab combination wasn’t likely to help patients live longer.
    • “The domvanalimab-based combination was the centerpiece of a partnership with Gilead Sciences that led the bigger company to buy a 33% stake in Arcus and pay $900 million just to secure rights.”

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

  • Healthcare Dive reports,
    • “Hospitals are managing series of cost, workforce and reimbursement challenges as they navigate uncertainty at the close of 2025 and beyond, according to a new report from Kaufman Hall.
    • “Health systems are attempting to mitigate the impact of tariffs and increasingly expensive supplies, according to Kaufman Hall’s 2025 Health System Performance Outlook report. At the same time, hospitals are trying to retain clinical staff and outsource other functions, according to the report.
    • “Only 30% of hospital leaders surveyed expect balance sheets to improve in 2026, while 30% expect them to lower and 40% projected little change. The split highlights how uncertain health systems feel about the future, especially from recent regulatory changes in the “Big Beautiful Bill” and the likely expiration of Affordable Care Act subsidies.”
  • Beckers Hospital Review relates,
    • “Dallas-based Tenet Healthcare reached a record high stock price of $218 on Nov. 25, capping off a transformative year that highlights investor confidence in the system’s ongoing shift toward specialty and outpatient care.
    • “As of Dec. 12, Tenet stock remained elevated at $199, up nearly 60% from $125 on Jan. 2. The spike reflects investor optimism around Tenet’s long-term strategy to transform into a value-based care enterprise anchored by its ambulatory business, United Surgical Partners International.
    • “In 2024, Tenet sold 14 hospitals for a combined $4.8 billion as part of a sweeping overhaul. The system now operates 50 acute-care hospitals while aggressively expanding its ambulatory surgery center footprint through USPI.”
  • Beckers Payer Issues tells us about 14 payer AI moves this year and “Turquoise Health has detailed its first comprehensive payer price transparency scores in its 2025 impact report, evaluating machine-readable file quality across 97 payers.” 

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.”