FEHBlog

Tuesday Tidbits

David Ermer–AHRQ, COVID-19, FDA, Federal employment benefits, HSA, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Federal News Network reports on the Postal Service Health Benefits Program supplemental rule creating a Medicare Part D EGWP mandate for Postal annuitants over 65, other than those living abroad.
  • While the FEHBlog thinks that the new, improved 2025 version of Medicare Part D is a good deal for FEHB and PSHB annuitants over age 65, even for those with the IRMAA tax or manufacturer coupons, the FEHBlog objects to the OPM mandate because it penalizes annuitants who opt out of the Plan’s Part D EGWP by barring them from the Plan’s prescription drug benefits without any premium reduction. Although FEHB plans do include penalties for failing to use hospital pre-certification, for example, those penalties top out at $500. Prescription drugs represent 24 cents out of every healthcare dollar according to AHIP. If Congress had intended that OPM impose such a hefty penalty, it would have said so in the Postal Reform Act. The law, however, is silent.
  • FedSmith offers advice on the upcoming Open Season while FedWeek explains the pros and cons about FEHB / PSHP high deductible plans with health savings accounts.
  • Per a CMS press release,
    • “The Centers for Medicare & Medicaid Services (CMS) announced today that the Medicare Shared Savings Program (Shared Savings Program) continues to save Medicare money while supporting high-quality care. The Shared Savings Program yielded more than $2.1 billion in net savings in 2023 — the largest savings in the Shared Savings Program’s history. In addition, Shared Savings Program Accountable Care Organizations (ACOs) are providing higher-quality care and supporting policies CMS has adopted to enhance primary care, expand access to accountable care to underserved communities, and prioritize quality care for common chronic conditions.
    • “In 2023, ACOs in the Shared Savings Program earned shared savings payments (also known as performance payments) totaling $3.1 billion, the highest since the program’s inception more than 10 years ago.  In addition, ACOs scored better on many quality measures than other types of physician groups and continued to demonstrate quality improvement. ACOs led by primary care clinicians had significantly higher net per capita savings than ACOs with a smaller proportion of primary care clinicians. These results continue to underscore how important primary care is to the success of the Shared Savings Program.”
  • Healthcare Dive tells us,
    • “Oracle Health will apply to become a Qualified Health Information Network under the federal government’s health data exchange framework, the technology giant said Monday. 
    • “TEFCA, or the Trusted Exchange Framework and Common Agreement, uses QHINs — which can represent dozens or hundreds of health systems, public health agencies, payers and health IT vendors — to support health information sharing, according to the HHS’ Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT.
    • “To get official designation, QHINs have to complete technology and security testing and agree to the data sharing rules before being onboarded. TEFCA went live in December with five QHINs, and two more organizations were approved early this year.”

From the public health and medical research front,

  • Fierce Pharma informs us,
    • “A small tweak in the dosing regimen of Eli Lilly’s Alzheimer’s disease drug Kisunla has reduced brain swelling of patients in a trial, the company said Tuesday.
    • “In the phase 3 study, 14% of patients who were on the altered dosing plan experienced brain swelling (ARIA-E) events at Week 24 versus 24% of those who received the standard dosing of Kisunla, which was approved by the FDA in July.
    • ‘The difference adds up to a 41% reduction in ARIA-E and could lead to a label change and help convince doctors to prescribe the anti-amyloid therapy, which is competing with another Alzheimer’s drug in its class, Eisai and Biogen’s Leqembi.”
  • Per MedTech Dive,
    • “Edwards Lifesciences’ Early TAVR trial results showed asymptomatic patients with severe aortic stenosis had better outcomes after transcatheter aortic valve replacement than under routine clinical surveillance.
    • “Analysts said the positive data could help Edwards reaccelerate growth in its TAVR business, where sales have slowed in recent quarters. The data were presented Monday at the Cardiovascular Research Foundation’s Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium and published simultaneously in The New England Journal of Medicine.
    • “The study is the first randomized, controlled trial to look at early intervention with TAVR as a strategy in patients with asymptomatic severe aortic stenosis, according to Edwards. The study was funded by Edwards.”
  • Per a company press release,
    • “Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) today announced that its double-blind, randomized, placebo-controlled global Phase 3 study, Stopping COVID-19 pRogression with early Protease InhibitOr treatment – Post Exposure Prophylaxis (SCORPIO-PEP), met its primary endpoint. Once-daily ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”) demonstrated a statistically significant reduction in the proportion of participants with symptomatic SARS-CoV-2 infection after exposure to household contacts with COVID-19 when compared to placebo. Specifically, the primary endpoint assessed COVID-19 symptoms onset through Day 10. Ensitrelvir was well tolerated by study participants and no new safety concerns were identified.
    • “Ensitrelvir is an investigational oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease. Ensitrelvir was granted Fast Track designation by the U.S. Food and Drug Administration in 2023 for the treatment of COVID-19. In Japan, ensitrelvir, known as Xocova®, received emergency regulatory approval in 2022 and full approval in March 2024 for the treatment of COVID-19. Ensitrelvir was also made available in Singapore based on the Special Access Route application in 2023. It remains an investigational drug outside of Japan and Singapore.
    • “COVID-19 remains an important public health priority, yet there are currently no oral antiviral medications approved for post-exposure prophylactic use. There is a need for convenient, preventive approaches to protect ourselves and those close to us from contracting SARS-CoV-2,” said Simon Portsmouth, MD, FRCP, Senior Vice President, Head of Clinical Development. “These data demonstrate a new potential for post exposure prophylactic use of ensitrelvir, expanding on the breadth of clinical and real-world evidence that establish its activity in those infected with SARS-CoV-2.”
  • AHRQ’s Medical Expenditures Panel Survey lets us know,
    • Among adults who reported ever having COVID-19, 13.7 percent reported ever having long COVID.
    • Women were more likely than men to report ever having long COVID (16.5% vs. 10.5%).
    • Adults aged 18-34 were less likely than all other age groups to report ever having long COVID (9.8% vs. 13.5%-17.9%).
    • Adults living in high-income households were less likely to report ever having long COVID (11.0%) than those living in middle-income households (15.6%), low-income or near poor households (17.4%), and those living in poor households (17.2%).
    • Adults living in a metropolitan statistical area reported lower rates of ever having long COVID than those living outside of a metropolitan statistical area (12.7% vs. 19.7%).
  • MedPage Today points out,
    • “Elevated body mass index (BMI) in children and young adults was associated with an increased risk of post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID, a large retrospective cohort study suggested.
    • “Those with obesity had a 25.4% increased risk of long COVID (relative risk [RR] 1.25, 95% CI 1.06-1.48) and those with severe obesity had a 42.1% increased risk (RR 1.42, 95% CI 1.25-1.61) compared with children and young adults who had healthy weight, reported Yong Chen, PhD, of the University of Pennsylvania in Philadelphia, and colleagues.
    • “Similarly, there was an increased likelihood of encountering any manifestation of potential long COVID symptoms and conditions among those with obesity (RR 1.11, 95% CI 1.06-1.15) and severe obesity (RR 1.17, 95% CI 1.14-1.21), they said in JAMA Network Openopens in a new tab or window.
    • “To our knowledge, this retrospective cohort study is the first and the largest to explore the association of BMI status with PASC among the pediatric population,” Chen and co-authors wrote. “The findings suggest that PASC may lead to poorer long-term quality of life, affecting physical health, educational achievement, and social development; this underscores the importance of early identification, prevention, and targeted interventions to mitigate these risks.”
  • The U.S. Preventive Services Task Force (USPSTF) has opened for a public comment the following recommendations:
    • Population: Pregnant or postpartum persons and women of reproductive age
    • Recommendation: The USPSTF recommends that clinicians screen for intimate partner violence (IPV) in pregnant and postpartum persons and women of reproductive age. See the “Practice Considerations” section for information on evidence-based multicomponent interventions and for information on IPV in men.
    • Grade: B
      Population: Older or vulnerable adults
      Recommendation The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for caregiver abuse and neglect in older or vulnerable adults. See the “Practice Considerations” section for additional information.
      Grade: I (inconclusive)
    • “In 2018, the USPSTF recommended that clinicians screen for IPV in women of reproductive age and provide or refer women who screen positive to ongoing support services. The USPSTF also concluded that the evidence was insufficient to assess the balance of benefits and harms of screening for abuse and neglect in all older or vulnerable adults. The current draft recommendation statement is consistent with the 2018 recommendation. To highlight that the evidence base focused on pregnant and postpartum persons, the USPSTF emphasized this population in this draft recommendation statement. For abuse of older or vulnerable adults, the term “caregiver” was added before abuse or neglect when appropriate to clarify when the focus was on screening for abuse or neglect perpetrated by a caregiver or someone they trust.”
    • The public comment deadline is November 25, 2024.
  • Healio relates that “A modified screening with additional questions about suicidal ideation was better at predicting suicide attempts among adolescents than the standard questionnaire, according to findings published in JAMA Network Open.“
  • The Wall Street Journal notes,
    • “In Appalachia, in the heart of one of the earliest and deadliest waves of the opioid crisis, doctors at West Virginia University’s Rockefeller Neuroscience Institute are conducting a radical experiment. Using focused ultrasound waves, they are resetting cells inside the brain’s reward center, the nucleus accumbens. They hope the procedure can treat addictions ranging from drugs like opioids and methamphetamine to gambling and eating. 
    • “While neuroscientists have long defined addiction as a brain disease, tools to fight the U.S. drug crisis that is behind 100,000 overdose deaths a year have changed little in decades. Most treatment involves medications like methadone and buprenorphine to replace other opioids, or naltrexone to block the part of the brain that feels pleasure from alcohol or opioids. For many addictions, counseling and abstinence-based 12-step programs remain the go-to treatment. 
    • “At RNI’s 30-patient residential-treatment program, more than two-thirds of patients relapse within the first few weeks. Many illicit drugs, including meth and cannabis, don’t have any prescription medications to treat the addiction.
    • “Now, the institute’s trial using ultrasound is a peek at a future that treats the physical brain, rather than using medication or behavioral approaches to alter outcomes. “We need to inject technology into this,” said Dr. Ali Rezai, a neurosurgeon and executive chair at the institute.
    • “The RNI team is also studying a pill that monitors vital signs and releases overdose-reversal medication automatically in people who overdose. In another trial, they are monitoring the heart rates, emotions, sleep and cravings of thousands of drug users who are helping to train artificial intelligence to predict a relapse before it occurs, so that recovery coaches can intervene.”   

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Pfizer PFE punched back against activist investor Starboard Value on Tuesday, delivering positive quarterly results.
    • “The pharmaceutical company raised its revenue outlook for the year to between $61 billion to $64 billion, up from $59.5 billion to $62.5 billion previously. It also raised its guidance on adjusted annual earnings per share to a range of $2.75 to $2.95, up from $2.45 to $2.65. 
    • “The encouraging third quarter comes as Pfizer faces pressure from activist investor Starboard, which says poor investments in research and dealmaking have helped destroy billions of dollars in market capitalization. The latest earnings highlight Pfizer’s third consecutive quarter with positive results—a bright spot that could bolster the drugmaker, and Chief Executive Albert Bourla’s efforts to revamp the company. 
    • ‘Pfizer also beat Wall Street’s expectations on quarterly sales and earnings. The company reported sales totaling $17.7 billion, driven by Covid-19 products and cancer medicines, up from the $14.9 billion forecast by analysts surveyed by FactSet. The Covid-19 antiviral Paxlovid generated $2.7 billion in quarterly sales, while its Covid-19 vaccine Comirnaty sold $1.4 billion, both topping analyst forecasts.”
  • Modern Healthcare informs us,
    • “CVS Health’s MinuteClinic is becoming an in-network primary care provider for select Aetna plan members.
    • “Aetna commercial, individual and family health plan members in San Antonio, Houston, Atlanta and south Florida have the option to use MinuteClinic as an in-network primary care provider, with members in North Carolina becoming eligible in the coming weeks, said Dr. Creagh Milford, retail health president at CVS Health.
    • “CVS has been investing in staffing, technology and training at its MinuteClinic sites for months to expand primary care services in certain markets chosen based on patient density, demographics and existing services in those areas, Milford said.
    • “We’re seeing a lot of growth in the model,” Milford said. “Our ambition is to move the patient perception and the payer perception from one of an episodic, acute care model toward a longitudal, relationship-based primary care model.”
    • “CVS is in talks with other health plans to grow the MinuteClinic primary care approach, he said.”
  • STAT News tells us,
    • “More than a year has passed since Dana-Farber Cancer Institute dumped Mass General Brigham for a rival hospital chain, but the state’s biggest health care system is making a push now to say when it comes to cancer care, MGB’s still got it.
    • “Beginning in 2028, Dana-Farber will end its long and nationally acclaimed adult oncology partnership with Brigham and Women’s Hospital. Instead, it will team up with Beth Israel Deaconess Medical Center to open a new freestanding 300-bed, $1.68 billion cancer hospital in the Longwood Medical Area.
    • “Dana-Farber’s announcement of the divorce in September 2023 stunned executives at the Brigham and rocked the hyper-competitive hospital industry. But now MGB is fighting back by creating what it calls the Mass General Brigham Cancer Institute, which the health system is trumpeting in an intensive marketing campaign.
    • “The institute won’t be a freestanding hospital. But it will, for the first time, combine the expertise and resources of MGB’s two flagship hospitals, Massachusetts General Hospital and the Brigham, whose cancer operations were previously separated by a firewall because of the latter’s partnership with Dana-Farber.
    • “What really started as a disruptive event a year ago, saying that Dana-Farber will be exiting after a few years, has now become a new opportunity for us to rethink how we deliver care,” O’Neil Britton, chief integration officer for MGB, said Monday at a round-table discussion at Massachusetts General Hospital with reporters.”
  • Per Fierce Pharma,
    • “Exactly three years after an initial FDA green light for the third-line treatment of leukemia, Novartis’ Scemblix has won an accelerated approval to treat newly diagnosed patients.
    • “Tuesday, the FDA cleared Scemblix to treat patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. The first-line nod marks an important step for the Gleevec follow-up on its way toward reaching the company’s peak sales projection of $3 billion. 
    • “Only about 15% of Ph+ CML patients reach the third-line treatment setting, Victor Bulto, Novartis’ U.S. president, noted in an interview with Fierce Pharma. 
    • “The Swiss drugmaker has its work cut out in this use. While Scemblix has quickly become the standard of care in third-line Ph+ CML because of a lack of alternative treatments, the first-line market will feature a couple hurdles for the new entrant.”
  • Per BioPharma Dive,
    • “Paragon Therapeutics, a biotechnology company creator with a web of spinouts, is taking a new startup public to develop an emerging type of cancer immunotherapy.
    • “The startup, Crescent Biopharma, on Tuesday announced a reverse merger with GlycoMimetics, a struggling, publicly traded developer of oncology and inflammatory disease drugs. In support of the deal, the combined company has raised $200 million in financing from 17 major investment firms — among them Fairmount and Venrock Healthcare Capital Partners — and expects that money to keep it operating through 2027.
    • “The new company will take the Crescent name, be about 97% owned by Crescent stockholders, and be led by the startup’s interim CEO and Fairmount venture partner Jonathan Violin. Its chief goal will be to advance a group of cancer medicines led by a dual-pronged immunotherapy that simultaneously targets the proteins PD-1 and VEGF.
    • “Study results in September showed that approach could improve upon standard immunotherapy treatments, like Merck & Co.’s Keytruda. Drugs targeting PD-1 and VEGF have since drawn the interest of an array of biotech companies, of which Crescent is the latest to emerge.”
  • and
    • “GSK will pay $300 million to acquire a bispecific antibody from Shanghai-based Chimagen Biosciences that it believes has the potential to treat autoimmune diseases like lupus.
    • “The drug, which is currently in Phase 1 testing for cancer in the U.S. and China, is what’s known as a “T cell engager.” It binds to two cell surface proteins called CD19 and CD20, which GSK notes could help deplete malfunctioning B cells.
    • “In a Tuesday statement, GSK said it plans to begin a Phase 1 trial of Chimagen’s drug sometime next year, assuming the proposed licensing deal clears customary regulatory review.”

Monday Roundup

David Ermer–CMS, Congress, FDA, Federal employment benefits, HSA, Medical / Rx research, Medicare, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Govexec offers a commentary on why federal and postal employees should consider a high deductible plan with a health savings account in the upcoming Open Season.
    • The FEHBP misses his CareFirst HDHP/HSA when Medicare became his primary health insurer at the end of 2019. The FEHBlog likes Medicare. He wonders whether the November 5 election is causing CMS to delay announcing Medicare premiums and cost sharing for 2025. Congress should pass a law requiring CMS to release this information before the beginning of the annual Medicare Open Enrollment on October 15.
  • Beckers Hospital Review lets us know,
    • Baxter has received FDA approval to extend the shelf life of more than 50 intravenous and irrigation products by up to 12 months, now allowing for a 24-month expiry from products made before September 2024, according to an Oct. 28 news release from the company. 
    • Here are four other IV shortage updates: 
      • A completed temporary bridge has already moved more than 825 truckloads of finished products from Baxter’s North Cove, N.C. facility. A second bridge is set to open in early November. 
      • Baxter anticipates restarting its primary IV solutions line the week of Oct. 28, aiming to begin distribution of new products by mid- to late November, the release said. 
      • Nine Baxter plants are supplementing North Cove’s output to stabilize supply levels in the U.S. 
      • Conservation efforts for IV and peritoneal dialysis solutions remain crucial, with Baxter’s supporting healthcare systems on product management strategies, according to the release. 
  • Federal News Network tells us,
    • “Agencies with higher employee satisfaction scores are also getting top marks on their performance.
    • “Research from the Partnership for Public Service finds agencies that received the highest internal customer experience scores also ranked high on the Federal Employee Viewpoint Survey.
    • “Brandon Lardy, the Partnership’s senior manager for data science and Strategy, said the study is part of its ongoing work to produce customer experience metrics on par with FEVS data or its Best Places to Work in the Federal Government ranking.”
  • The Wall Street Journal reports,
    • “The Biden administration took steps to alleviate shortages of cancer drugs for children, part of a final push for one of the president’s domestic priorities: reducing the nation’s cancer burden.
    • “The federal government is testing a new way to prevent treatment disruptions for seven pediatric cancer drugs by improving communication between hospitals, nonprofits and wholesalers. Shortages of cancer medicines regularly plague hospitals and patients, sometimes forcing them to delay or change care. 
    • “No one in this country should struggle for access to the treatment they need, but kids and families facing cancer in particular,” said Danielle Carnival, an adviser to Biden who leads his “Cancer Moonshot” effort.” 

From the public health and medical research front,

  • STAT News reports,
    • “If one can point to anything good about the H5N1 bird flu outbreak in dairy cattle — to be honest, there’s nothing good about this situation — it’s the timing. Transmission of the virus through U.S. dairy herds took off when last winter’s flu season was effectively over, making the job of looking for people infected with H5N1 an easier task in theory, though there have been plenty of human hurdles impeding those efforts.
    • “But in the months since the outbreak was first detected, the spread of the virus in cows has not been contained, with infections reported in 380 herds in 14 states so far. Now, with cold and flu season looming, it is likely to become significantly more difficult for the country’s public health departments to track the virus. 
    • “If one can point to anything good about the H5N1 bird flu outbreak in dairy cattle — to be honest, there’s nothing good about this situation — it’s the timing. Transmission of the virus through U.S. dairy herds took off when last winter’s flu season was effectively over, making the job of looking for people infected with H5N1 an easier task in theory, though there have been plenty of human hurdles impeding those efforts.
    • “But in the months since the outbreak was first detected, the spread of the virus in cows has not been contained, with infections reported in 380 herds in 14 states so far. Now, with cold and flu season looming, it is likely to become significantly more difficult for the country’s public health departments to track the virus.”
  • Beckers Hospital Review names the ten most health and the ten least health cities in our country.
    • “Detroit leads the list of cities with the least healthy populations, while San Jose, Calif., has the healthiest residents, according to a new ranking published Oct. 28 by Forbes Advisor, a financial services and personal finance website affiliated with Forbes.
    • “In making its determination, Forbes Advisor compared the 46 most populated U.S. cities with available data across eight metrics. Metrics ranged from the number of heart disease deaths per 100,000 residents to the percentage of adults who report physical inactivity.
    • “Data for the analysis comes from the City Health Dashboard and the Census Bureau. Read more about the methodology here.”
    • Austin, Texas, where the FEHBlog lives, is listed as the city with the second healthiest population, following San Jose, California.
  • Consumer Reports, writing in the Washington Post, discuss “seven winning dietary supplements for sleep, bone health and more. As for which brands, the key is choosing products that have been verified to be free of contaminants and to contain what their labels claim.”
  • Per National Institutes of Health press releases,
    • “A study from researchers at National Institutes of Health (NIH) and their collaborators revealed a significant genetic risk factor for kidney disease in people from Ghana and Nigeria. Their study demonstrated that having just one risk variant in a gene known as APOL1 can significantly increase the risk of developing kidney disease. APOL1 is important for the immune system and variants of the gene are linked to increased risk of chronic kidney disease. The study is published in the New England Journal of Medicine and was conducted by researchers from the Human Heredity and Health in Africa (H3Africa) Kidney Disease Research Network.
    • “Previous research established that genomic variants in APOL1 increase the risk of developing chronic kidney disease among African Americans. However, not much is known about how these genomic variants affect people from West African countries, where many African Americans derive genetic ancestry. Studying how these genomic variants contribute to chronic kidney disease in West Africans and people with West African ancestry can also help inform the risk of kidney disease in many Americans.”
  • and
    • “A highly pathogenic avian influenza (HPAI) H5N1 virus, isolated from the eye of a farm worker who became infected through contact with dairy cows, was lethal in mice and ferrets infected in a high-containment laboratory environment, according to a new study in Nature. The study investigators also found that the virus isolated from the worker, who experienced mild inflammation of the cornea (conjunctivitis), could be transmitted through the air between separated ferrets and might be capable of binding to and replicating in human respiratory tract cells.
    • “The virus isolated from the worker is called huTX37-H5N1 and has a mutation (PB2-E627K) frequently seen in avian influenza viruses that replicate in mammals, typically making virus replication more efficient. These mutations underscore the need for continued monitoring and evaluation of viruses from the current H5N1 outbreak.
    • “The study also showed that a bovine H5N1 virus is susceptible to the antiviral drugs favipiravir and baloxavir marboxil (brand name Xofluza) of the polymerase inhibitor class, as well as the neuraminidase inhibitor zanamivir. The virus is less sensitive to oseltamivir (Tamiflu), another neuraminidase inhibitor.” * * *
    • “In summary, this study characterizes the huTX37-H5N1 isolate, finding that it may be capable of replicating in cells of the respiratory tract in humans, that it is pathogenic in mice and ferrets, and that it is capable of being transmitted by the respiratory route in ferrets. The authors note that “based in these observations, every effort should be made to contain HPAI H5N1 outbreaks in dairy cattle to limit the possibility of further human infections.”
  • From the U.S. healthcare business front,
  • AHIP shows us where our healthcare dollar goes.
  • For experience rated FEHB plans, which serve the vast majority of subscribers, the profit is less than one cent of each dollar. Other FEHB plans can enjoy the 2.4 cents profit.
  • Beckers Hospital Review points out “50 things to know about hospital consolidation and what consolidation means for the future of healthcare.
  • Per Fierce Healthcare
    • “Leaders at UnitedHealth Group and Amedisys are set to meet with the Department of Justice this week in hopes of avoiding a potential attempt to block their $3.3 billion merger deal, according to media reports.
    • “Bloomberg reported that the “last rites” meeting is generally the last step before regulators decide to intervene in a deal or not. It’s possible that the antitrust enforcers will allow the two companies to move forward with the deal with some changes that address competition concerns, according to the article.
    • “People familiar with the matter told Bloomberg there has been no definitive decision to challenge the deal. The DOJ will need to make a choice by the end of the month, based on an arrangement with UHG and Amedisys, according to the article.”
  • and
    • “Elevance Health plans to acquire home health company CareBridge in a deal that’s reportedly worth $2.7 billion.
    • “Elevance CEO Gail Boudreaux told investors on the company’s earnings call earlier this month that the company’s Carelon division “recently” entered into a deal to acquire CareBridge. 
    • “Further details on the transaction have not yet been disclosed. The Nashville Business Journal, where CareBridge is based, reported that Elevance Health would pay $2.7 billion for the home health company. The article called CareBridge the “fastest growing” company in the Tennessee city.
    • “On the call, Boudreaux said that CareBridge will “serve as the foundation for Carelon’s home health business, and we’re excited to continue to serve all its customers and members.” CareBridge provides value-based care in the home and community for people with complex and chronic conditions.”
  • and
    • “Universal Health Services (UHS) beat analysts’ estimates for third-quarter revenue as its top line grew 11% from 3.963 billion to reach $3.96 billion thanks to solid growth by its acute care hospitals and behavioral health care services.
    • “A year ago, UHS brought in $3.56 billion in revenue in the third quarter of 2023.
    • “The King of Prussia, Pennsylvania-based for-profit health system reported that adjusted admissions rose 1.5% from a year ago. Meanwhile, the total number of days patients stayed increased by 2% as compared to the same period in 2023.” * *
    • “The company also saw net revenue per adjusted admission rise by 7% while net revenue per adjusted patient day increased by 6.5% as compared to the third quarter of 2023. Net revenue from hospital services rose by 9.2% during the third quarter of 2024.
    • “UHS has approximately 96,700 employees and, through its subsidiaries, operates 27 inpatient acute care hospitals and 333 inpatient behavioral health facilities as well 40-plus outpatient facilities and ambulatory care access points. UHS also has an insurance offering and a physician network.”
  • Per Healthcare Dive,
    • “Providence is expanding its presence in the home care market after the nonprofit health system agreed to launch a joint venture this week with home care provider Compassus.
    • “The JV, which will be called Providence at Home with Compassus, will offer home health, hospice, community-based palliative care and private duty caregiving services. 
    • “Compassus will manage operations, according to a press release. The JV will operate 24 home health locations in Alaska, California, Oregon and Washington, and 17 hospice and palliative care locations in Alaska, California, Oregon, Texas and Washington. There’s no timeline yet on when the parties might finalize the proposed JV, and the deal is still pending regulatory review in Oregon.”
  • The Wall Street Journal reports,
    • “AbbVie has agreed to buy Aliada Therapeutics, a biotechnology company backed by Johnson & Johnson, for $1.4 billion in cash in a deal that adds a potential therapy for Alzheimer’s disease to AbbVie’s neuroscience pipeline.
    • “AbbVie on Monday said Aliada’s lead investigational asset, ALIA-1758, is an anti-pyroglutamate amyloid beta antibody that uses a novel blood-brain barrier-crossing technology and is in development for the treatment of the memory-robbing disease.” * * *
    • “The deal is slated to close by the end of the year.”

Weekend Update

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, SCOTUS, U.S. Healthcare–

From Washington, DC

  • Congress remains on the campaign trail until the lame duck session begins November 12.
  • On October 7, the Supreme Court invited the Solicitor General to file a brief in a Tenth Circuit ERISA preemption case, Mulready v. PCMA, No. 23-1213, expressing the views of the United States. The case bears on FEHB preemption of state PBM laws regulating PBM contracts with FEHB carriers. Because the national election will result in a new President on January 20, 2024, it’s likely that the Solicitor General will not submit a brief in this case until next Spring.
  • Beckers Payer Issues offers a useful perspective on HHS OIG and other investigative reports alleging that Medicare Advantage plans game the Medicare program by arranging for plan nurses to visit plan members to conduct health risk assessments.
    • “In a statement published Oct. 24, Mary Beth Donahue, president and CEO of the Better Medicare Alliance, said the report “paints a misleading picture of in-home health assessments.” 
    • “The Better Medicare Alliance is backed by major insurers. 
    • “Medicare Advantage is designed to achieve a better overall understanding of individuals’ health, and in-home assessments are a crucial part of this model,” Ms. Donahue said. “This information ensures seniors get the resources they need. We have supported codified best practices for these assessments and will continue to do so.” 
    • “In an Oct. 24 statement, AHIP, the trade association representing insurers, said CMS did not concur with key recommendations in the OIG’s report. 
    • “The agency did not concur with recommendations from the OIG to restrict payments for diagnoses found during in-home visits. 
    • “In its statement, AHIP said that health risk assessments are “one of many tools” MA plans use to identify chronic conditions and prevent these conditions from becoming more serious. 
    • “Whether they occur in the patient’s home or in a clinical office setting, the HRA offers an opportunity for the health plan and provider to obtain a complete evaluation of the patient’s physical, behavioral, and mental health needs, medications, health risks, and environmental factors that affect health,” the association said.” 
  • Cardiovascular Business tells us,
    • “Medtronic has received U.S. Food and Drug Administration (FDA) approval for its new Affera mapping and ablation system with the Sphere-9 catheter, an all-in-one electrophysiology offering capable of pulsed field ablation (PFA) and radiofrequency (RF) ablation. The system was approved to treat persistent atrial fibrillation (AFib) and cavotricuspid isthmus-dependent atrial flutter. It previously received CE mark approval in March 2023.
    • “Medtronic is now the first company to offer two FDA-approved PFA systems for the treatment of AFib. The company’s PulseSelect PFA system gained FDA approval in December 2023. 
    • “The Sphere-9 catheter at the heart of this system includes a 9 mm lattice tip designed to deliver wide-area circumferential ablations. It can provide either pulsed field or RF energy, a feature that puts more treatment options at the fingertips of operators than other commercially available PFA offerings. 
    • “The significance of this innovative technology should be underscored; Affera is a game changer for treatment of AFib and atrial flutter,” Vivek Reddy, MD, director of cardiac arrhythmia services for the Mount Sinai Health System in New York City and a known leader in ablation technologies, said in a statement. “The Affera system provides physicians with one safe, effective and efficient solution to this common and increasing problem in heart disease that needs optimized solutions for patients. With a short learning curve for experienced physicians, the possibilities are boundless for the treatment of AFib.”

From the public health and medical research front,

  • The AP reports,
    • “McDonald’s announced Sunday that Quarter Pounders will again be on its menu at hundreds of its restaurants after testing ruled out beef patties as the source of the outbreak of E. coli poisoning tied to the popular burgers that killed one person and sickened at least 75 others across 13 states.
    • “The U.S. Food and Drug Administration continues to believe that slivered onions from a single supplier are the likely source of contamination, McDonald’s said in a statement. It said it will resume selling the Quarter Pounder at affected restaurants —- without slivered onions — in the coming week.
    • “As of Friday, the outbreak had expanded to at least 75 people sick in 13 states, federal health officials said. A total of 22 people had been hospitalized, and two developed a dangerous kidney disease complication, the Centers for Disease Control and Prevention said. One person has died in Colorado.”
  • Fortune Well identifies 17 factors that may play a role in whether a person suffers a stroke.
    • Stroke rates are rising, with over half a million Americans having a first stroke every year. But up to 80% of strokes may be preventable, which is why it’s so important to understand and mitigate your risk factors.
    • That’s according to the American Stroke Association, which this week released its first new clinical guidelines for strokes in a decade. 
  • Fortune Well also shares four lessons about “leadership, parenting, and setbacks” that the UPS Stores president learned from suffering a severe heart attack at age 47.
    • “Sarah Casalan remembers several clear details from the night of her heart attack two years ago: First, she kept thinking she had indigestion from the hamburger she’d made herself for dinner the night before, though it was unusual, considering her “iron stomach.” But then she felt so awful that she lay on the bathroom floor, sweaty and nauseous, for over an hour—and found she could not get up.
    • “That was when the alarm bells went off, though I couldn’t, even at that moment, imagine I was having a heart attack,” says Casalan, president of the UPS Store Inc. and a single mom to two boys who were 6 and 7 at the time. After all, she was just 47, active, and in generally good health. “And why would I think I was having a heart attack without chest pain?” 
    • “Casalan eventually got herself up and to her mom, who happened to be visiting that night, and from there “it was a total of about five minutes between the realization that I could be having a heart attack to unconsciousness.” Turns out she was suffering from full blockage in her left ascending artery—prompting a heart attack known as a “widowmaker”—which has just a 12% survival rate outside of hospitals for women. (Doctors have since theorized that it could’ve been brought on by having had an “overly inflamed” heart after a bout with COVID.)”
  • Per Medscape,
    • “A new study provides real-world evidence to support the potential repurposing of glucagon-like peptide 1 receptor agonists (GLP-1 RAs), used to treat type 2 diabetesand obesity, for prevention of Alzheimer’s disease (AD). 
    • “Adults with type 2 diabetes who were prescribed the GLP-1 RA semaglutide had a significantly lower risk for AD compared with their peers who were prescribed any of seven other antidiabetic medications, including other types of GLP-1 receptor–targeting medications. 
    • “These findings support further clinical trials to assess semaglutide’s potential in delaying or preventing AD,” the investigators, led by Rong Xu, PhD, with Case Western Reserve School of Medicine, Cleveland, Ohio, write. 
    • “The study was published online on October 24 in Alzheimer’s & Dementia.”
  • and
    • “For patients with metabolic dysfunction–associated steatotic liver disease (MASLD) and diabetes, treatment with a glucagon-like peptide 1 receptor agonist (GLP-1 RA) may protect against progression to cirrhosis and mortality; however, the protective benefits do not extend to patients who already have cirrhosis, a new study found.”
  • The Wall Street Journal reports,
    • “Imagine being able to control a computer with your thoughts—even more easily and quickly than using your hands. That is the goal of Precision Neuroscience. Using brain-computer interfaces, it aims to transform the lives of people with physical challenges.
    • “The Wall Street Journal’s Rolfe Winkler spoke with Michael Mager, co-founder and chief executive of Precision Neuroscience, and Benjamin Rapoport, the company’s co-founder and chief science officer. [The article provides] edited excerpts of their discussion at the annual WSJ Tech Live conference.

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “HCA Healthcare took a $50 million financial hit in the third quarter due to the impacts of the back-to-back hurricanes Helene and Milton, which slammed facilities in North Carolina, Georgia and Florida.
    • “The for-profit health system told investors on Friday morning that it expects to feel the effects of the two storms in the fourth quarter as well, with additional hurricane-related costs likely to be between $200 million and $300 million, according to a press release.
    • “HCA noted that these projections do not account for insurance recoveries it may receive.” 
  • ‘Beckers Payer Issues tell us,
    • “Eighteen insurers have exited Medicare Advantage markets for 2025, with more than 1.8 million people currently enrolled in plans that will not exist next year, according to OliverWyman.
    • “Market exits by Humana, Aetna, and UnitedHealthcare collectively affect nearly 70% of those 1.8 million individuals.
    • “It’s important to highlight that these plan exits reflect members who will not be automatically moved into other products, even if one was available,” OliverWyman analysts wrote. “While these plan exits may seem alarming, carriers in many of these markets have introduced new products or have other products that members can switch to for 2025.”
  • Per Beckers Hospital Review,
    • ‘U.S. Bankruptcy Court Judge Christopher Lopez approved the sale of seven Dallas-based Steward Health Care hospitals to Healthcare Systems of America, an affiliate of Glendale, Calif.-based American Healthcare Systems during an Oct. 25 court hearing.
    • “Steward sought Chapter 11 protection May 6 and has been working to sell its 31 hospitals.
    • “The Steward hospitals are Houston-based St. Joseph Medical Center, Port Arthur-based Medical Center of Southeast Texas, Coral Gables (Fla.) Hospital, Hialeah (Fla.) Hospital, Miami-based North Shore Medical Center, Lauderdale Lakes, Fla.-based Florida Medical Center and Hialeah, Fla.-based Palmetto General Hospital. 
    • “Healthcare Systems of America has been interim manager of the hospitals and Steward’s West Monroe, La. -based Glenwood Regional Medical Center since Sept. 11.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Federal News Network tells us,
    • “The White House’s lead regulatory office is reviewing a proposed rule that would upgrade the cybersecurity protections required under the Health Insurance Portability and Accountability Act (HIPAA).
    • “The White House Office of Information and Regulatory Affairs (OIRA) received the proposed rule on Oct. 18.
    • The changes to the HIPAA security rule will “improve cybersecurity in the health care sector by strengthening requirements for HIPAA regulated entities to safeguard electronic protected health information to prevent, detect, contain, mitigate, and recover from cybersecurity threats,” according to a rule abstract published by OIRA.
    • “OIRA is charge of reviewing major agency rulemakings before they are published. Once the HIPAA updates clear White House review, the Department of Health and Human Services would be able to release the Notice of Proposed Rulemaking for public comment.”
  • Here’s the entry in reginfo.gov
    • AGENCY: HHS-OCR. RIN: 0945-AA22. Status: Pending Review. Request EO Meeting
      TITLE: Proposed Modifications to the HIPAA Security Rule to Strengthen the Cybersecurity of Electronic Protected Health Information
      STAGE: Proposed Rule. SECTION 3(f)(1) SIGNIFICANT: Yes. RECEIVED DATE: 10/18/2024
      LEGAL DEADLINE: None  
  • Fedscoop tells us,
    • “The Biden administration published its anticipated national security memo on artificial intelligence Thursday, establishing a roadmap that aims to ensure U.S. competitiveness with adversaries on the technology, while still upholding democratic values in its deployment. 
    • “Specifically, the memo details more responsibilities for the Department of Commerce’s AI Safety Institute, directs agencies to evaluate models for risks and identify areas in which the AI supply chain could be disrupted, outlines actions to streamline acquisition of AI used for national security, and defines new governance practices for federal agencies through a new framework.
    • “In remarks on the memo delivered Thursday at National Defense University, National Security Advisor Jake Sullivan highlighted the potential AI has for the country’s national security advantage but spoke in dire terms about taking action.
    • “The stakes are high,” Sullivan said. “If we don’t act more intentionally to seize our advantages, if we don’t deploy AI more quickly and more comprehensively to strengthen our national security, we risk squandering our hard-earned lead.”
  • Per a NIST announcement,
    • “NIST has released an initial public draft (ipd) revision of Special Publication (SP) 800-131A, Transitioning the Use of Cryptographic Algorithms and Key Lengths.
    • “NIST provides cryptographic key management guidance for defining and implementing appropriate key-management procedures, using algorithms that adequately protect sensitive information, and planning for possible changes in the use of cryptography because of algorithm breaks or the availability of more powerful computing techniques. This publication provides guidance on transitioning to the use of stronger cryptographic keys and more robust algorithms.
    • “This revision proposes a) the retirement of ECB as a confidentiality mode of operation and the use of DSA for digital signature generation and b) a schedule for the retirement of SHA-1 and the 224-bit hash functions. This draft also discusses the transition from a security strength of 112 bits to a 128-bit security strength and to quantum-resistant algorithms for digital signatures and key establishment.
    • “The public comment period is open through December 4, 2024. See the publication details for a copy of the draft and instructions for submitting comments.”
  • The Wall Street Journal reports,
    • “Four tech companies settled federal cases over allegations they misled investors about the extent to which they were compromised in the 2020 SolarWinds hack. 
    • “Avaya Holdings, Check Point Software Technologies, Mimecast and Unisys didn’t admit wrongdoing in separate deals with the U.S. Securities and Exchange Commission, which found their financial disclosures played down what the companies knew about how their systems were affected by breached SolarWinds software. 
    • “Unisys agreed to pay a penalty of $4 million, and the other three companies will pay about $1 million each.
    • “In a breach disclosed in 2020, which the U.S. later attributed to Russia, hackers slipped malicious code into software from Austin, Texas-based SolarWinds. Thousands of customers inadvertently downloaded the malware. Moscow has denied involvement.”

From the cybersecurity vulnerabilities and breaches front,

  • Cyberscoop lets us know,
    • “The Change Healthcare data breach in February affected 100 million Americans, the company told the Health and Human Services Department this week, making it the biggest breach of health care data ever reported to U.S. regulators.
    • “The development is the latest ripple in what was already an unprecedented attack, one in which the company paid a $22 million ransom, resulted in estimated losses of more than $1 billion and attracted the attention of policymakers who have sought new rules for the industry.
    • “Change Healthcare notified HHS about the updated number, with the company previously stating only that “a substantial proportion of people in America” were affected. HHS posted about the new figure it in its own update Thursday. HHS’s Office of Civil Rights is conducting an investigation of the breach.
    • “The previous record for victims of a breach in the sector was the Anthem breach of 2015, which impacted nearly 79 million Americans and resulted in the company paying a $16 million settlement to HHS.”
  • Cybersecurity Dive adds,
    • “Attackers are actively exploiting a critical zero-day vulnerability in Fortinet’s network and security management tool FortiManager, according to security researchers and federal authorities. The earliest exploitation was on June 27, and at least 50 organizations across various industries have been impacted to date, Mandiant said in a Wednesday blog post.
    • “Fortinet disclosed active exploitation of CVE-2024-47575, which has a CVSS score of 9.8, in a security advisory Wednesday. Hours later, the Cybersecurity and Infrastructure Security Agency added the CVE to its known exploited vulnerabilities catalog. Fortinet did not say how many customers are impacted or when it became aware of CVE-2024-47575 and active exploitation.
    • “The exploitation observed thus far appears to be automated in nature and is identical across multiple victims,” Mandiant Consulting CTO Charles Carmakal said in a Wednesday post on LinkedIn. “However, with most mass exploitation campaigns, we often observe targeted follow-on activity at some victims.”
  • Dark Reading informs us,
    • “Russia’s premiere advanced persistent threat group has been phishing thousands of targets in militaries, public authorities, and enterprises.
    • “APT29 (aka Midnight Blizzard, Nobelium, Cozy Bear) is arguably the world’s most notorious threat actor. An arm of the Russian Federation’s Foreign Intelligence Service (SVR), it’s best known for the historic breaches of SolarWinds and the Democratic National Committee (DNC). Lately, it has breached Microsoft’s codebase and political targets across Europe, Africa, and beyond. Russia’s premiere advanced persistent threat group has been phishing thousands of targets in militaries, public authorities, and enterprises.
    • “APT29 embodies the ‘persistent’ part of ‘advanced persistent threat,'” says Satnam Narang, senior staff research engineer at Tenable. “It has persistently targeted organizations in the United States and Europe for years, utilizing various techniques, including spear-phishing and exploitation of vulnerabilities to gain initial access and elevate privileges. Its modus operandi is the collection of foreign intelligence, as well as maintaining persistence in compromised organizations in order to conduct future operations.”
  • Per Bleeping Computer,
    • “Cisco fixed a denial-of-service flaw in its Cisco ASA and Firepower Threat Defense (FTD) software, which was discovered during large-scale brute force attacks against Cisco VPN devices in April.
    • ‘The flaw is tracked as CVE-2024-20481 and impacts all versions of Cisco ASA and Cisco FTD up until the latest versions of the software.
    • “A vulnerability in the Remote Access VPN (RAVPN) service of Cisco Adaptive Security Appliance (ASA) Software and Cisco Firepower Threat Defense (FTD) Software could allow an unauthenticated, remote attacker to cause a denial of service (DoS) of the RAVPN service,” reads the CVE-2024-20481 security advisory.”

From the ransomware front,

  • Dark Reading points out,
    • “Nearly 400 US healthcare organizations have been infected with ransomwarethis fiscal year, compromising private information, disrupting facilities, and putting lives at risk, according to a study released this week.
    • “The average payment that these organizations have reported paying has gone up to roughly $4.4 million and is costing facilities up to $900,000 in downtime, putting healthcare among ransomware’s most lucrative target sectors.
    • “The disruption that healthcare operations face when hit with ransomware attacks doesn’t just affect hospitals either. It also impacts clinics and doctors in adjacent areas, which absorb displaced patients in these emergencies.” * * *
    • According to the study, ransomware has become such a pronounced issue for the healthcare sector because of its track record of complying with the bad actors and making ransom payments. But since these organizations are dealing with literal life and death issues, they are usually willing to pay millions of dollars to avoid any disruption of care and the data that support it.
  • Cyberscoop relates,
    • “Ransomware developers are used to their malware being detected. Once defenses against it have been built, they revise and update their code to circumvent those defenses. Then developers deploy an updated version in renewed attacks, often with increased sophistication, to evade detection and achieve their malicious objectives.
    • “That cycle has started anew with the Qilin ransomware-as-a-service operation, according to a new report from the cybersecurity firm Halcyon about the group’s updated and upgraded variant. 
    • “Researchers at the firm warned Thursday that “Qilin.B” is a “more advanced” ransomware variant that boosted encryption and evasion techniques to the big game hunters’ arsenal.
    • “Qilin.B’s combination of enhanced encryption mechanisms, effective defense evasion tactics, and persistent disruption of backup systems marks it as a particularly dangerous ransomware variant,” the report noted.”
  • Per Cybersecurity Dive,
    • “Ransomware attacks hit at least 30 organizations using SonicWall firewalls running firmware affected by a critical vulnerability the vendor disclosed and patched two months ago, security researchers at Arctic Wolf Labs said Thursday.
    • “SonicWall disclosed and patched the improper access control vulnerability, CVE-2024-40766, which has a CVSS score of 9.3, on Aug. 22. Arctic Wolf Labs said it began observing Akira and Fog ransomware variant intrusions involving the affected SSL VPN feature of SonicWall firewalls in early August.
    • “We have observed a significant increase in activity consistent with attempted intrusions since August, with spikes in activity typically occurring during non-business hours,” Bret Fitzgerald, senior director of global public relations at SonicWall, said Thursday via email.”
  • Bleeping Computer alerts us,
    • “The BlackBasta ransomware operation has moved its social engineering attacks to Microsoft Teams, posing as corporate help desks contacting employees to assist them with an ongoing spam attack.
      “Black Basta is a ransomware operation active since April 2022 and responsible for hundreds of attacks against corporations worldwide.
      “After the Conti cybercrime syndicate shut down in June 2022 following a series of embarrassing data breaches, the operation split into multiple groups, with one of these factions believed to be Black Basta.”

From the cybersecurity defenses front,

  • Cybersecurity Dive reports,
    • “Microsoft Chair and CEO Satya Nadella asked for the board to reduce part of his annual compensation package to account for his role in how the company prepared for malicious cyberattacks that led to an overhaul of its internal security culture. 
    • “Nadella received more than $79 million in total compensation in fiscal 2024, which included a base salary of $2.5 million, about $71.2 million in stock awards and $5.2 million in non-equity incentive plan compensation, according to a filing with the Securities and Exchange Commission. The total included almost $170,000 classified as other compensation. 
    • “However, Nadella “asked the board to consider departing from the established performance metrics and reduce his cash incentive to reflect his personal accountability for the focus and speed required for the changes that today’s cybersecurity threat landscape showed were necessary,” according to a letter included in the filing from the compensation committee at Microsoft.” 
  • Per Bleeping Computer,
    • Apple created a Virtual Research Environment to allow public access to testing the security of its Private Cloud Compute system, and released the source code for some “key components” to help researchers analyze the privacy and safety features on the architecture.
    • The company also seeks to improve the system’s security and has expanded its security bounty program to include rewards of up to $1 million for vulnerabilities that could compromise “the fundamental security and privacy guarantees of PCC.”
    • Private Cloud Compute (PCC) is a cloud intelligence system for complex AI processing of data from user devices in a way that does not compromise privacy.
  • Cybersecurity Dive shares Gartner’s four ways AI could impact employees, workflows.
  • Here is a link to Dark Reading’s CISO Corner.
  • An ISACA commentator discusses “How the Emerging Technology Landscape is Impacting Cybersecurity Audits.”
  • “In a conversation with The Regulatory Review, Penn Medicine Chief Privacy Officer Lauren Steinfeld discusses how health care systems work to comply with regulations on data privacy.”
  • Tripwire shares “Advanced Tips for Leveraging the NIST Cybersecurity Framework for Compliance.”

Friday Factoids

David Ermer–ACA, CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Obesity, U.S. Healthcare–

From Washington, DC

  • NBC 10 Buffalo NY reports
    • Capital District Physicians’ Health Plan (CDPHP) will no longer be offering its plan for Federal Government employees. A spokesperson for CDPHP said this affects about 6,000 members.
    • “At the beginning of 2024, due to compounding regulations and rising administrative costs, CDPHP made the difficult decision to exit the Federal plan at the end of this plan year,” said the spokesperson. “Federal plan employees will need to select a new plan/carrier during this year’s Open Season.”
    • The FEHBlog remembers an OPM FEHB carrier conference which featured a CDPHP speaker due to the quality of the Plan’s services.
    • OPM does pile benefit and administrative costs on FEHB carriers. The straw that may have broken the camel’s back was OPM’s January 2023 mandate to cover GLP-1 drugs for obesity. That unexpected cost still reverberates in FEHB premiums today.
    • The FEHBlog is not saying that OPM should not have mandated GLP-1 drugs for obesity. The FEHBlog is saying that OPM should have put that mandate in a call letter for benefit and rate proposals so that plans could build the cost into their premiums as federal procurement law requires.
  • The OPM Inspector General weighed in again on the Postal Service Health Benefits Program implementation process.
  • The Miller and Chevalier law firm lets us know,
    • “On October 17, 2024, the Internal Revenue Service (IRS) issued Notice 2024-75 to expand preventive care benefits permitted by a high deductible health plan (HDHP) under section 223(c)(2)(C) of the Internal Revenue Code. The guidance states that over-the-counter (OTC) contraceptives and male condoms, types of breast cancer screenings beyond mammography, and certain types of diabetes care all qualify as preventive care.” * * *
    • “Notice 2024-75 is generally effective for plan years that begin on or after December 30, 2022.”
    • “In related concurrent guidance, the IRS issued Notice 2024-71, which provides a safe harbor for amounts paid for condoms by use by the taxpayer, spouse, or dependent under section 213(d) of the Code. “
  • The American Hospital Association tells us,
    • “The Centers for Medicare & Medicaid Services Oct. 25 launched a preview of health coverage options available through the Open Enrollment Period for the HealthCare.gov marketplaces, set to open on Nov. 1. The Administration also announced Deferred Action for Childhood Arrivals recipients will be eligible to enroll in a marketplace plan and may be eligible for other benefits to lower health insurance out of pocket costs. As part of this year’s open enrollment, CMS updated the HealthCare.gov webpage and made it mobile-friendly to ease the enrollment process. The ACA marketplace open enrollment runs from Nov. 1 to Jan. 15.”
  • Here is a link to the related CMS fact sheet.
  • Per JD Supra,
    • “On October 15, Maryland Attorney General Anthony G. Brown announced that his office reached a $27 million settlement with Precision Toxicology to resolve allegations that it submitted false claims to government health programs for medically unnecessary urine drug tests and provided illegal kickbacks to physicians.
    • “Precision Toxicology, headquartered in San Diego, CA, is one of the nation’s largest urine drug testing laboratories. According to the fact recitation in the settlement documents, Precision allegedly submitted false claims for drug tests to Medicare, Medicaid, TRICARE, the Federal Employees Health Benefits Program (FEHBP), and the Department of Veterans Affairs (VA) for a period of approximately 10 years. The drug test claims submitted to the programs were allegedly medically unreasonable and unnecessary. Specifically, Precision allegedly utilized nonallowable blanket orders for urine drug tests without physician authorization and offered free point-of-care drug test cups to physicians in exchange for referrals, in violation of the Anti-Kickback Statute.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is declining in most areas. Minimal seasonal influenza activity is occurring nationally. Signs of increased RSV activity have been detected in the southeastern United States, particularly in young children. Respiratory infections caused by the bacterium Mycoplasma pneumoniae have increased in the United States, especially in young children.
    • “COVID-19
      • “Nationally, COVID-19 activity has continued declining in most areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels. Nationally, COVID-19 infections are predicted to be growing slowly from a low level.
      • “The XEC variant is predicted to increase to 14-22% among circulating viruses as of October 26, 2024. Because XEC is recombined from two JN.1 lineage viruses, the 2024-2025 COVID-19 vaccines that already include JN.1 strains are still expected to provide protection. Similarly, there are no impacts currently expected on tests, treatments, or symptoms at this time. For additional information, please see CDC COVID Data Tracker: Variant Proportions. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity is low. However, signs of increased RSV activity have been detected in the southeastern U.S., particularly in young children.
    • “Vaccination
  • The University of Minnesota’s CIDRAP adds,
    • Wastewater detections [of the COVID virus] remain at low levels nationally, but detections tracking a bit higher in the West and Midwest compared to other regions, according to CDC data. Similarly, WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, said its monitoring has the nation at the medium level, with a downward trend over the past 3 weeks. It said the South and West are now in the low category.
  • The Food and Drug Administration informs us,
    • “Today, the FDA updated the advisory for the outbreak of E. coli O157:H7. A specific ingredient has not yet been confirmed as the source of the outbreak, but most sick people report eating McDonald’s Quarter Pounder burgers. Investigators are working to determine if the slivered onions or beef patties on Quarter Pounder burgers are the likely source of contamination. McDonald’s has temporarily stopped using Quarter Pounder slivered onions and beef patties in affected states. Diced onions and other types of beef patties used at McDonald’s have not been implicated in this outbreak. Additionally, Taylor Farms has initiated a voluntary recall of some onions sent to food service customers. Customers who are impacted have been contacted directly. As of Oct. 24, 75 people infected with the outbreak strain of E. coli O157:H7 have been reported from 13 states. Illnesses started on dates ranging from Sept. 27, 2024, to Oct. 10, 2024. Of 61 people with information available, 22 have been hospitalized and two people developed hemolytic uremic syndrome, a serious condition that can cause kidney failure. One death has been reported from an older adult in Colorado. Of the 42 people interviewed, all 42 (100%) report eating at McDonald’s and 39 people report eating a beef hamburger. Consumers who have already eaten at McDonald’s and have symptoms of E. coli infection should contact their health care provider to report their symptoms and receive care immediately. The FDA is working closely with the U.S. Department of Agriculture, the Food Safety and Inspection Service, the Centers for Disease Control and Prevention and state partners to determine if the slivered onions or beef patties on Quarter Pounder burgers are the likely source of contamination. Additional information will be published in the advisory as it becomes available.” 
  • The American Medical Association offers “top health tips that pediatricians want parents to know.”
  • Per Fierce Pharma,
    • “Despite recent concerns from the FDA about potential off-label use and antimicrobial resistance, Dublin-based Iterum Therapeutics has scored a green light for its oral antibiotic sulopenem.
    • “Sulopenem, which will now go by the commercial moniker Orlynvah, was approved by the FDA Friday to treat uncomplicated urinary tract infections (uUTIs) caused by E. coli, Klebsiella pneumoniae or Proteus mirabilis in adult women who have limited or no alternative antibacterial treatment options.
    • “The FDA nod—Iterum’s first—marks the second approval this year for a uUTI medicine after two decades of stagnation in the field. It also represents the first U.S. approval for an oral penem—a class of antibiotics.
    • “Back in April, the FDA approved Utility Therapeutics’ Pivya (pivmecillinam). The penicillin antibiotic underpinning Utility’s drug had never before been cleared in the U.S., despite being approved in Europe for more than 40 years.”
  • Medscape tells us,
    • “The incidence of atrial fibrillation (AF) is on the rise, and recent joint guidelines from the American College of Cardiology and American Heart Association (ACC/AHA) stress the role of primary care clinicians in prevention and management.
    • “One in three White and one in five Black Americans will develop AF in their lifetime, and the projected number of individuals diagnosed with AF in the United States is expected to double by 2050.
    • “Cardiologists who spoke to Medscape Medical News said primary care clinicians can help control AF by focusing on diabetes and hypertension, along with lifestyle factors such as diet, exercise, and alcohol intake.
    • “It’s not just a rhythm abnormality, but a complex disease that needs to be addressed in a multidisciplinary, holistic way,” said Jose Joglar, MD, a professor in the Department of Internal Medicine at the UT Southwestern Medical Center in Dallas and lead author of the guidelines.
    • Joglar said primary care clinicians can play an important role in counseling on lifestyle changes for patients with the most common etiologies such as poorly controlled hypertension, diabetes, and obesity.”
  • STAT News lets us know,
    • “For people with obesity, surgeries that shrink, reshape, or otherwise alter the anatomy of the stomach have long reigned supreme as the surest way to weight loss. But in the last few years, with the approval of GLP-1 drugs like Wegovy and Zepbound, more and more people are opting for obesity medicines over gold-standard surgical treatments. 
    • “On a population level, among a subset of commercially insured individuals, that is the tradeoff that is happening” said Thomas Tsai, the lead author of a new study that looked at health records of 17 million privately insured Americans with obesity. It found that between 2022 and 2023, as prescriptions for GLP-1 drugs more than doubled, rates of bariatric surgery fell by 25.6%.
    • “The findings, published Wednesday in JAMA Network Open, mark a sharp turnaround from trends over the last decade, and spell an uncertain future for hospitals and clinics that derive a significant portion of their revenues from such procedures.”

From the U.S. healthcare business front

  • Beckers Payer Issues relates,
    • “Centene reported $713 million in net income in the third quarter, per its earnings report published Oct. 25.
    • “Total revenues in the third quarter were $42 billion, up 10.5% year over year.
    • “Total net earnings in the third quarter were $713 million, up 52% since the same period last year.
    • “The company reaffirmed its year-end adjusted EPS guidance of greater than $6.80.
    • ‘The company’s medical loss ratio was 89.2% in the third quarter and 87% during the same period last year.”
  • Per Healthcare Dive,
    • “Medicaid payment rates have yet to catch up with rising costs in the safety-net insurance program. However, conservative planning — along with business growth — yielded a surprisingly positive third quarter for health insurer Molina, according to analysts.
    • “Molina beat Wall Street expectations for earnings and revenue with a topline of $10.3 billion in the quarter, up 21% year over year, thanks in part to higher premiums. Profit of $326 million was up 33% year over year.
    • “Molina appears to be “beating the odds again” in Medicaid, Jefferies analyst David Windley said in a note on the payer’s results.”
  • Beckers Hospital Review points out that “Nashville, Tenn.-based HCA Healthcare posted an operating income of $1.9 billion (10.9% operating margin) in the third quarter of 2024, up from an operating income of $1.6 billion (10.1% margin) over the same period last year, according to its Oct. 25 financial report.”
  • Per MedTech Dive,
    • “Baxter plans to restart its highest throughput manufacturing line for IV solutions within the next week, “barring any unanticipated developments,” the company said on Thursday.
    • “Baxter is working to restore production at a North Carolina plant that makes about 60% of the U.S. supply of IV fluids, and is an important supplier of peritoneal dialysis solutions, according to the American Hospital Association.
    • “The company still has not shared a timeline for restoring full production at the facility after it was flooded by Hurricane Helene in early October. Baxter’s goal is to begin resuming production in phases by the end of the year.”
  • The Washington Post offers an interview with JC Scott, president and CEO of the Pharmaceutical Care Management Association (PCMA), the PBM trade association.
  • Beckers Payers Issues shares executive opinions on “opportunities payers can seize next year.”
  • Per Healthcare Dive,
    • “Cost management company MultiPlan is facing yet another lawsuit for allegedly conspiring to underpay providers — this time, from the largest physician association in the United States.
    • “The American Medical Association’s complaint, filed Thursday in an Illinois district court, accuses MultiPlan of colluding with major health insurers to set artificially low reimbursement rates for out-of-network care, forcing providers to accept payments that often don’t cover their operating costs.
    • “The litigation, which asks the judge for an injunction requiring MultiPlan to halt the illegal practices, is the latest in a long string of suits against the company. Congress is also scrutinizing MultiPlan, which denies the allegations.”

Thursday Miscellany

David Ermer–Uncategorized–

From Washington, DC

  • OPM’s supplemental Postal Service Health Benefits Program final rule was published in the Federal Register today.
  • The FEHBlog is disappointed that OPM is pursuing a modified version of its Part D opt out penalty when 2025 Medicare Part D benefits are so obviously generous. Everyone should put more effort into promoting the advantages of 2025 Part D benefits, e.g., $2000 out of pocket maximum.
  • The FEHBlog also is disappointed that OPM is declining to share Medicare coordination of benefits information, such as Medicare beneficiary identifiers, with FEHB and PSHB carriers when for 35 years the FEHB Act has required OPM in combination with HHS to provide carriers with a Medicare coordination of benefits database. 5 U.S.C. Sec. 8910(d).
  • Govexec encourages federal employees to consider enrolling in a high deductible FEHB plan for 2025 so that they can enjoy the triple tax-free benefits of a health savings account.
  • Reg Jones writing in FedWeek discusses vesting in the federal retirement system.
  • Per an HHS press release,
    • Today, HHS Secretary Xavier Becerra released the following statement in response to new fluid supply increases from Baxter, Inc.:
    • “I am encouraged by reports that Baxter anticipates restarting the highest throughput manufacturing line at Baxter’s North Cove facility next week – sooner than originally expected. There’s more to do, including meeting regulatory requirements of the product manufactured on the restarted line, but this is good news for partners and patients. This progress is the result of a strong public-private partnership. We have quickly facilitated the import of product from six facilities around the world. We have made it easier for hospitals to produce their own IV fluid during the shortage. And HHS will continue to use all necessary authorities to bolster supply and mitigate impact to patients. I want to thank everyone for their continued work on this important part of the recovery process.”

From the public health and medical research front,

  • A “USDA/HHS Fact Sheet [explains the new actions that the] Biden-Harris Administration [is taking] * * * to Halt the Spread of Bird Flu, including in California and Washington.
  • The New York Times adds,
    • “A Missouri resident who shared a home with a patient hospitalized with bird flu in August was also infected with the virus, federal officials reported on Thursday.
    • “But symptomatic health care workers who cared for the hospitalized patient were not infected, testing showed. The news eased worries among researchers that the virus, H5N1, had gained the ability to spread more efficiently among people.
    • “Still, the number of human cases is rising in the United States. California said this week that it had confirmed 15 human cases of bird flu. Washington State has reported two poultry workers who are infected and five others presumed to be positive.
    • “There are 31 confirmed cases in the country, but experts have said the figure is likely to be an undercount. “Additional cases may be found as investigations continue,” Dr. Nirav Shah, the principal deputy director of the Centers for Disease Control and Prevention, said at a news briefing on Thursday.”
  • The AP reports,
    • “A California-based produce company was the source of fresh onions linked to a deadly E. coli food poisoning outbreak at McDonald’s, officials with the restaurant chain said Thursday. Meanwhile, other fast-food restaurants — including Taco Bell, Pizza Hut, KFC and Burger King — pulled onions from some menus.
    • “McDonald’s officials said that Taylor Farms, of Salinas, California, sent onions to one distribution facility, which led the fast-food chain to remove Quarter Pounder hamburgers from restaurants in several states. McDonald’s didn’t say which facility it was.
    • “An outbreak tied to the burgers has sickened at least 49 people in 10 states, including a person who died, federal health officials have said. Investigators said they were focused on slivered onions as a potential source of the infections.” * * *
    • “Officials with the U.S. Food and Drug Administration did not confirm that the agency is investigating Taylor Farms. A spokesperson said Thursday that the agency is “looking at all sources” of the outbreak.”
  • ABC News tells us,
    • “Thousands of bottles of a popular antidepressant medication are being recalled due to the presence of what the National Library of Medicine describes as a toxic chemical, according to a notice from the U.S. Food and Drug Administration.
    • “The recall involves the medication duloxetine, which is sold under the brand name Cymbalta, according to the FDA’s notice of the voluntary recall, which began Oct. 10.
    • “Duloxetine is part of a class of drugs known as SNRIs, or selective serotonin/norepinephrine reuptake inhibitors, that are used to treat anxiety, depression and other mood disorders, according to the FDA.”
  • NIH Director, Dr. Monica Bertagnolli, writes in her blog,
    • “You’ve surely seen fruit flies in your kitchen, perhaps hovering around a bowl of citrus fruits or over a glass of wine. While these insects might not seem especially brainy, typical fruit fly behaviors depend on a complex brain that’s wired to solve many of the same problems human brains do. Their nervous systems and brains must pick up on tempting scents and send the right signals through their bodies to move from one place to another to find food. Fruit flies form long-term memories, engage in social interactions with other fruit flies, and navigate over long distances. Though smaller than a poppy seed, the fruit fly brain is packed with hundreds of thousands of neurons and millions of neural connections all wired precisely to make those behavioral feats possible.
    • “Now, a scientific team supported by the NIH Brain Research Through Advancing Innovative Neurotechnologies® Initiative, or The BRAIN Initiative®, has unveiled the first complete map, or connectome, of every neural connection within the brain of an adult female fruit fly. This important milestone in brain science, reported in nine papers in Nature, details more than 50 million connections between nearly 140,000 neurons. As the first complete map of a connectome of any adult animal, it offers critical information about how complex brains are wired to send and receive signals underlying normal brain functions.” * * *
    • “While there’s still a lot to learn about how the human brain is wired and how it works, the fruit fly connectome serves as an important step toward developing the tools and capabilities required for mapping larger-brained animals and, eventually, the human brain, with its more than 80 billion neurons and 100 trillion connections. The connectome and the many exciting discoveries and developments yet to come will be critical for bringing much needed advances in understanding and one day treating a wide range of human brain disorders, including Alzheimer’s disease, Parkinson’s disease, severe depression, and addiction.”

From the U.S. healthcare business front,

  • Beckers Hospital Review shares information on Health Grade awards for hospital special care.
  • The American Journal of Managed Care informs us,
    • “Value-based care prioritizes patient outcomes and cost reduction, requiring alignment of reimbursement models and financial sustainability management.
    • “Private insurers are reforming payment models, but aligning specialty care with value-based goals remains challenging.
    • “Financial pressures and data integration are key hurdles in transitioning to value-based care, necessitating innovative partnerships.
    • “Educating patients about value-based care options is essential to reduce unnecessary emergency department visits and improve care outcomes.”
  • and
    • “Social determinants of health significantly influence health care costs across Medicare, Medicaid, and private insurance programs.
    • “Educational attainment and social isolation notably affect Medicaid expenditures, with higher costs linked to lower education and increased isolation.
    • “Neighborhood quality and economic stability are key factors in Medicare spending, impacting costs based on access to parks and financial confidence.
    • “Medical discrimination and debt collection contact are associated with increased private insurance expenditures.
    • “Integrating SDOH into policy could help manage healthcare costs and promote health equity, though challenges persist in implementation.”
  • Ken Kaufmann from Kaufmann Hall opines that “Changing American Demographics Make Hospital Operations Harder,” and he offers some ideas to help hospitals out.

Midweek Update

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC

  • On Wednesday morning, OPM’s supplemental Postal Service Health Benefits Program final rule was posted on the Federal Register’s Public Inspection List. The Federal Register version of the rule is being published on Thursday October 24, a week or so earlier than expected.
  • The final rule maintains OPM’s proposed exclusion of Part D eligible Postal annuitants from their PSHB plan’s prescription drug benefits in the event that they opt out of their Plan’s Part D EGWP benefits. A Part D EGWP integrates the Plan’s benefits with Medicare Part D benefits.
  • A Part D EGWP member subjected to the Part D EGWP penalty continues to pay the full employee / annuitant premium for FEHB coverage.
  • On the brighter side, the final rule does prohibit PSHB plans from auto enrolling Part D eligible annuitants who live overseas because they cannot receive Medicare Part D coverage. OPM also created an opportunity for Postal annuitants to reverse course and join the Part D EGWP if they realize that opting out was a mistake. See 89 Fed. Reg. 85012, 85022.
  • MedPage Today reports,
    • “The CDC’s Advisory Committee on Immunization Practices (ACIP) on Wednesday endorsed additional doses of COVID vaccine for high-risk groups and recommended lowering the age for adult pneumococcal vaccination from 65 to 50 years.
    • “In an update to recommendations from June in three unanimous votes, ACIP recommended a second dose of the 2024-2025 COVID vaccine for adults ages 65 and older, as well as people ages 6 months to 64 years who are moderately or severely immunocompromised, and additional (three or more) doses for people ages 6 months and older who are moderately or severely immunocompromised under shared clinical decision making.
    • “The advisors also voted 14-1 to recommend a pneumococcal conjugate vaccine (PCV) for all PCV-naive adults ages 50 and older.
    • “Shortly after the ACIP meeting, CDC Director Mandy Cohen, MD, MPH, endorsed the new COVID vaccine and pneumococcal vaccine recommendations.”
  • BioPharma Dive adds,
    • “The Food and Drug Administration on Tuesday expanded the approval of Pfizer’s RSV vaccine Abrysvo to include adults aged 18 to 59 years who are at an increased risk of disease from respiratory syncytial virus.
    • “The vaccine was previously cleared in adults aged 60 years and older, as well as in pregnant women who are between 32- and 36-weeks’ gestation. With the latest expansion granted by the FDA, Pfizer claims its vaccine now holds the “broadest” indication for adults.
    • “In June, the Centers for Disease Control and Prevention tightened its guidance for RSV vaccination in older adults and delayed making recommendations for adults younger than 60. Advisers to the CDC are set to discuss RSV vaccine data this week but aren’t scheduled to vote on guidance for younger adults.”
  • Healthcare Dive lets us know,
    • “Centene is suing the federal government over its 2025 Medicare Advantage star ratings, the latest in a string of lawsuits from health insurers looking to protect their scores — and the valuable revenue they represent.
    • “The lawsuit filed Tuesday in a Missouri district court accuses the HHS of mishandling a “secret shopper” call meant to assess the quality of Centene’s customer call center, and unfairly including that call in the insurer’s ratings.
    • “Several of Centene’s plans received lower scores as a result, which could cost the insurer $73 million in revenue and cause enrollees to leave the plans — “staggering consequences” from a single call, according to the suit. Centene is requesting the judge order the CMS to recalculate its ratings without including the disputed call.”

From the public health front,

  • NBC News’ Today Show offers updated details on the McDonald’s E. coli outbreak.
  • NBC News reports,
    • Not having — or losing — your sense of smell may be linked to changes in breathing that could lead to depression, social isolation or other mental and physical health problems, a new study suggests. It’s more evidence of how important this often neglected olfactory sense is. 
    • A new analysis of breathing data from 52 volunteers over a 24-hour period revealed that people with a normal sense of smell had little spikes, or “sniffs,” during each breath that were not seen in those with no sense of smell, according to the report published in Nature Communications on Tuesday.” * * *
    • “The main takeaway from the study is better insight into some of the mental issues that some Covid patients who have lost their sense of smell experience, said the study’s lead author, Lior Gorodisky, a Ph.D. candidate in the brain sciences department at the Weizmann Institute of Science in Rehovot, Israel.” * * *   
    • “The little inhalations during a breath, known as the “sniff response,” are something that most of us experience unconsciously every day, Gorodisky said. Those little sniffs tell our brains about good and bad smells. “When you go to a bakery or a flower field, once your brain has sensed the good smell of a pastry or a flower, you immediately take a deeper breath,” Gorodisky said.”
        
  • The National Cancer Institute’s latest Cancer Information Highlights concern “Easing Money Troubles | Cachexia | Nutrition.”
  • Per an NIH press release,
    • “The National Institutes of Health (NIH) has launched a proof-of-concept precision medicine clinical trial to test new treatment combinations targeting specific genetic changes in the cancer cells of people with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The trial, funded by NIH’s National Cancer Institute (NCI), aims to accelerate the discovery of more tailored treatments for these aggressive cancers of the blood and bone marrow.
    • “NCI is uniquely positioned to conduct this type of study, which is one of a series of NCI precision medicine trials that are helping pave the way for more personalized treatment of cancer,” said W. Kimryn Rathmell, M.D., Ph.D., director of NCI. “By making these trials available to patients in communities around the country, we bring cutting edge science to people where they live and ensure that what we learn from our study participants can benefit patients like them in the future.”  * * *
    • “Learn more about myeloMATCH and the sub-studies that are currently open.”

From the U.S. healthcare business front,

  • Beckers Hospital Review identifies Healthgrades’ 50 top hospitals for surgical care, by state. 
  • Fierce Healthcare tells us,
    • “Sanford Health and Marshfield Clinic Health System have signed a merger agreement, the health systems announced on Wednesday, after first revealing their intent to combine in July.
    • “The systems said the combining would enable them to significantly improve the quality of care available to people living in the rural Midwest. Should the merger complete, the combined health system’s revenue would be about $10 billion.
    • “Sanford is the largest rural health system in the United States, including 45 hospitals, 211 clinics and more than 160 senior living centers. The Sioux Falls, South Dakota-based provider employs 2,900 physicians and advanced practice providers.
    • “Marshfield, meanwhile, has 60 clinics, 11 hospitals and a children’s hospital. It employs more than 1,700 providers, according to the announcement.
    • “Each also operates a health plan, and combined membership would top 425,000, the health systems said. * * *
    • “The deal is expected to close by the end of the year.”
  • Healthcare Dive informs us about “Executives from Amazon, Walgreens, Blue Shield of California and PhRMA [who] weighed in on how to fix the much-scrutinized pharmacy benefit manager model during HLTH 2024.”

Tuesday’s Tidbits

David Ermer–ACA, AHRQ, CDC, Congress, FDA, HSA, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • OMB’s Office of Information and Regulatory Affairs disclosed it has completed its work on OPM’s supplemental Postal Service Health Benefits rule. That rule now should appear in the Federal Register’s public inspection list shortly. The rule by the way is not on today’s list.
  • The International Foundation of Employee Benefit Plans tells us,
    • The Internal Revenue Service (IRS) released annual inflation adjustments for more than 60 tax provisions in Revenue Procedure 2024-40. Many of these adjustments affect employee benefits.
    • For example,
      • Health flexible spending cafeteria plans. For the taxable years beginning in 2025, the dollar limitation for employee salary reductions for contributions to health flexible spending arrangements rises to $3,300, increasing from $3,200 in tax year 2024. For cafeteria plans that permit the carryover of unused amounts, the maximum carryover amount rises to $660, increasing from $640 in tax year 2024.
      • HSA/HDHP changes were announced before the call letter responses were due at the end of May 2024.
  • The Wall Street Journal adds,
    • “The brackets that determine how much Americans pay in taxes each year are moving up by their smallest amount in a few years.
    • “It will take more income to reach each higher tax bracket after the roughly 2.8% inflation adjustment for 2025, the Internal Revenue Service said Tuesday. The annual adjustments are based on formulas tied to inflation.
    • “This year’s adjustments slightly outpace the current inflation rate, which has been cooling. Still, average hourly earnings rose 4% from a year earlier in September, the Labor Department said.”
  • Per an HHS press release,
    • “Today, the Department of Health and Human Services (HHS), through the Office of Assistant Secretary for Planning and Evaluation (ASPE), released new data showing that nearly 1.5 million people with Medicare Part D saved nearly $1 billion in out-of-pocket prescription drugs costs in the first half of 2024 because of the Biden-Harris Administration’s Inflation Reduction Act. Thanks to the Inflation Reduction Act, some people with high drug costs have their out-of-pocket drug costs capped at around $3,500 in 2024. Next year that cap lowers to $2,000 for everyone with Medicare Part D. The report shows that if the $2,000 cap had been in effect this year, 4.6 million enrollees would have hit the cap by June 30 and would not have to pay any more out-of-pocket costs for the rest of the year.”
    • “To view the full ASPE issue brief, “Medicare Part D Enrollees Reaching the Out-of-Pocket Limit by June 2024” visit: https://aspe.hhs.gov/reports/medicare-part-d-oop-cap“
  • KFF offers a data note.
    • “Overall, just under half of individuals with job-based health coverage are enrolled as a dependent on a family member’s plan (47%). The likelihood of enrolling as a dependent decreases with age. Nearly all children (ages 0-17) with employer-sponsored coverage are enrolled as dependents, usually on a parent’s plan. Young adults, particularly those ages 18-25, are more likely to be covered as dependents than adults overall (72% vs. 32%).
    • “The Affordable Care Act (ACA) requires most employer plans allow young adults to remain on a parent’s plan until age 26. Before the ACA, employers typically limited dependent eligibility for young adults to an age less than 26 and often imposed additional eligibility requirements. This provision of the ACA maintains considerable popularity and has been credited with reducing the uninsured rate among young adults. In 2024, 56% or 19.3 million young adults aged 18-25 were covered on an employer-sponsored plan (Figure 1).
    • “As young adults age, a greater share of those with employer coverage transitions from dependent coverage to being policyholders. For instance, while a majority of 18 and 19-year-olds with employer-sponsored coverage are still covered as dependents, the proportion decreases among those aged 24 and 25 (93% vs. 50%) (Figure 2).”
  • Seeking Alpha lets us know,
    • “Sen. Dick Durbin (D-Ill.), chairman of the Senate Judiciary Committee, has sent letters to Pfizer and Eli Lilly regarding the two drug giants’ relationships with telehealth platforms.
    • “Durbin is seeking to find out whether the two pharmaceutical companies are violating federal anti-kickback laws, according to the letters.
    • “Both Pfizer and Lilly this year launched websites for consumers to find out about their medications, as well as links to talk to a physician online that can prescribe them and an online pharmacy to get prescriptions filled. Pfizer’s is called PfizerForAll, while Lilly’s is name LillyDirect.
    • “Durbin, along with Sens. Bernie Sanders (I-Vt.), Elizabeth Warren (D-Mass.), and Peter Welch (D-Vt.), argue that these setups are designed to push consumers to particular drugs “and create the potential for inappropriate prescribing that can increase spending for federal health programs.”
    • “Regarding Pfizer’s platform, the senators say the ease of getting meds prescribed “creates the impression that any patient interested in a particular medication can indeed receive it with just a few clicks, and the appearance of Pfizer’s approval that these chosen telehealth providers can ensure a patient receives the given medication.”
  • It strikes the FEHBlog as strange that these legislators are attacking the drug manufacturers for disintermediating the middlemen.
  • Fierce Pharma reports
    • “With Johnson & Johnson sweetening the pot and mustering up the support of 83% of those who claim that the company’s talc products caused their cancer, it had appeared that the sides were speeding toward a resolution of the litigation through J&J’s third bankruptcy attempt.
    • “But the U.S. Department of Justice (DOJ) has called a foul.
    • “In federal bankruptcy court in Houston, Texas, the U.S. Trustee program—the DoJ’s unit that oversees bankruptcy cases—has filed a motion (PDF) to dismiss a Johnson & Johnson subsidiary’s Chapter 11 bid to settle the 60,000-plus talc lawsuits.”
  • MedTech Dive lets us know,
    • “The Food and Drug Administration on Tuesday named Michelle Tarver as the permanent director of the agency’s device center, first reported by Stat and confirmed by MedTech Dive.
    • “Tarver was appointed as acting director of the Center for Devices and Radiological Health in July, when longtime leader Jeff Shuren stepped down. 
    • “FDA Commissioner Robert Califf emphasized Tarver’s “passion about data, science, medicine, and the evidence” and work to build collaboration and transparency at the agency, in an email to staff announcing the new director’s appointment viewed by MedTech Dive.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “Four workers at a commercial egg farm in Washington tested presumptively positive for H5N1 bird flu, the Washington State Department of Health announced Oct. 20. These are the first presumed human cases in the state. The individuals experienced mild symptoms and Benton-Franklin Health District officials have forwarded test samples to the Centers for Disease Control and Prevention for final confirmation and analysis. Washington is the sixth state with human H5N1 infection, which has caused outbreaks in poultry, dairy cattle and wildlife. The CDC considers the risk of H5N1 bird flu to the general public to be low.”
  • The New York Times tells us,
    • “New guidelines for preventing strokes spell out for the first time the risks faced by women, noting that pre-term births and conditions like endometriosis and early menopause can raise the risk.
    • “Prior guidelines tended to be sex-agnostic,” said Dr. Brian Snelling, director of the stroke program at Baptist Health South Florida’s Marcus Neuroscience Institute, who was not involved in writing the guidelines.
    • “Now we have more data about sex-specific subgroups, so you’re able to more appropriately screen those patients.”
    • “The focus of the recommendations by the American Stroke Association, published on Monday in the journal Stroke, is primary prevention — the effort to prevent strokes in individuals who have never had one. It represents the first such update in a decade, and it’s the playbook by which millions of Americans will be cared for.”
  • BioPharma Dive reports about “RNA editing: emerging from CRISPR’s shadow. Early study data from Wave Life Sciences suggests how editing RNA may yield viable medicines. Large and small drugmakers say such results are just the start.”
    • “RNA editing is a fast growing corner of the biotechnology sector. About a dozen companies, from privately held startups to established biotech firms, are pursuing the technology. One already has early, but promising, clinical trial results. Others could follow soon. And large pharmaceutical companies, such as Eli Lilly, Roche and Novo Nordisk, have taken an interest.
    • “RNA editing’s proponents say it may be safer and more flexible than DNA editing. Those advantages, they contend, will enable RNA editing to address more diseases, including common conditions that are now beyond genetic medicine’s reach.
    • “It has all the features of a technology that could leapfrog other editing technologies,” said Michael Ehlers, a general partner at Apple Tree Partners and the CEO of RNA editing startup Ascidian Therapeutics.”
  • The U.S. Preventive Services Task Force has opened for public comment its Grade B recommendation that doctors “provide or refer pregnant and postpartum persons to interventions that support breastfeeding.” This is a confirmation of a 2016 Grade B recommendation. The public comment period is open until November 18, 2024.
  • Per Food Navigator
  • The Centers for Disease Control and Prevention issued the following alert today.
    • CDC, FDA, USDA FSIS, and public health officials in multiple states are investigating an outbreak of E. coli O157:H7 infections. Most people in this outbreak are reporting eating the Quarter Pounder hamburger at McDonald’s before becoming sick. It is not yet known which specific food ingredient is contaminated.
    • McDonald’s is collaborating with investigation partners to determine what food ingredient in Quarter Pounders is making people sick [mostly in Colorado and Nebraska]. McDonald’s stopped using fresh slivered onions and quarter pound beef patties in several states while the investigation is ongoing to identify the ingredient causing illness.
  • The Washington Post reports,
    • TreeHouse Foods has expanded an earlier recall of frozen waffles to include all its griddle products, including Belgian waffles and pancakes, over possible listeria contamination.
    • Though no illnesses have been reported, TreeHouse Foods has previously said that the breakfast products were widely distributed throughout the United States and Canada, primarily as private-label offerings by Walmart, Target, Tops, Harris Teeter, Publix and other large merchants.
    • The suspected contamination was discovered through routine testing at a manufacturing facility in Ontario, according to the company announcement.
    • “We are working with our retail customers to retrieve and destroy the recalled products, and encourage consumers to check their freezers for any of the products subject to the recall and dispose of them, or return them to the place of purchase for a refund,” the company said in an unsigned email.

From the U.S. healthcare business front,

  • OptumRx discusses its efforts to “automate prior authorization process for prescription drugs to improve the patient and provider experience.”
  • MedTech Dive brings us up to date on what happened at the MedTech Conference held last week in Canada.

Monday Roundup

David Ermer–ACA, CDC, FDA, Medical / Rx research, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • Today, the Affordable Care Act (ACA) regulators issued ACA FAQ 68 and a related HHS fact sheet. This letter addresses ongoing preventive care coverage issues separate from the proposed ACA rule, also issued today along with an HHS fact sheet, to expand contraceptive coverage with no cost sharing to include the OTC contraceptive pill and more.  The proposed rule will be open for public comment for sixty days after publication in the Federal Register. Government actions like the proposed rule, in the FEHBlog’s opinion, are a principal cause of skyrocketing medical costs.
  • Govexec reports,
    • “More than 200,000 U.S. Postal Service employees will receive a nearly 5% pay raise over the next year if its largest letter carriers’ union agrees to the new contract its leaders have negotiated with agency management. 
    • “The employees will also have more opportunities for overtime and be able to reach the top slots of their pay scales more quickly, the National Association of Letter Carriers said of their new tentative agreement. The contract must still be approved by NALC members before it goes into effect. A failure to ratify the deal would likely result in arbitration. 
    • “The agreement would cover the period from May 2023 into November 2026, meaning the first two of the three scheduled 1.3% wage increases would apply retroactively. Employees would also receive a series of cost-of-living adjustments, the first three would also be paid retroactively and total around $2,300. 
    • “After almost 20 months of tireless negotiations, we are pleased to reach a fair agreement that rewards our members for their contributions to the Postal Service and their service to the American people,” NALC President Brian Renfroe said.” 
  • MedTech Dive informs us,
    • “Boston Scientific received Food and Drug Administration approval for Farawave Nav, a treatment for paroxysmal atrial fibrillation (AFib) that enables cardiac mapping and pulsed field ablation (PFA) therapy with a single integrated catheter.
    • “In tandem, the company gained 510(k) clearance for new software, called Faraview, to provide visualization for cardiac ablation procedures with its Farapulse PFA system, the medical device maker said Friday. Boston Scientific will immediately launch the Farawave Nav ablation catheter and Faraview software in the U.S. 
    • “In a race among medtech companies in the PFA space, Boston Scientific is now the first with mapping-integrated PFA, “a meaningful technology step-forward,” Stifel analyst Rick Wise said Sunday in a note to clients.”
  • and
    • “The Food and Drug Administration updated the recall notice for a Boston Scientific product that blocks blood flow.
    • “Boston Scientific recalled the product, Obsidio Conformable Embolic, in February in response to a problem then linked to seven injuries and two deaths. On Friday, the FDA updated its Class I recall notice, reporting an additional two deaths and eight injuries.
    • “The FDA provided the new information after Boston Scientific on Oct. 11 updated its instructions for use for the device, which stayed on the market after the recall. While the prior alert warned of risks for lower gastrointestinal (GI) bleeding, the revised instructions reflect evidence of risks when the product is used anywhere in the GI area.”

From the public health and medical research front,

  • Health Day tells us,
    • “Walking pneumonia cases are surging among young children in the United States, federal health officials warn.
    • “Bacterial infections caused by Mycoplasma pneumoniae increased in the United States since late spring and have remained high,” a statement issued Friday by the U.S. Centers for Disease Control and Prevention noted. “The proportion of patients discharged from emergency departments with a diagnosis of M. pneumoniae-associated pneumonia or acute bronchitis has been increasing over the past six months, peaking in late August.”
    • “The worst rates of the illness have been seen in young children ages 2 to 4, according to the agency.
    • “The increase in children ages 2–4 years is notable because M. pneumoniae historically hasn’t been recognized as a leading cause of pneumonia in this age group,” the CDC added.”
  • NBC News informs us,
    • “Since 2000, breast cancer incidence among Asian American and Pacific Islander women under 50 years old has increased by 50%, more than 2% every year since 2012, according to a new report from the American Cancer Society.
    • “Asian American and Pacific Islander women in this age cohort had the second-lowest rate of breast cancer among all racial groups in 2000. They now have the highest rate alongside white women, about 86 per 100,000.
    • “Breast cancer is still more common the older we get, but it’s alarming to see younger women being diagnosed,” said Dr. Helen Chew, director of the clinical breast cancer program at UC Davis Health.
    • “Breast cancer has risen sharply among younger Asian American women in the past quarter-century due in part to acculturation and greater awareness around screenings, though experts say more research is required to determine exact causes for specific ethnic groups.
    • “Asian women like Huang have a higher prevalence of dense breasts, meaning there are more glands and tissue than fat, than women of other races, likely due to genetic factors and lower body mass indexes, experts say. And women with dense breasts are four times as likely to develop breast cancer as those with fatty breasts, an issue experts say needs more awareness.”
  • MedPage Today points out,
    • “The American Heart Association and the American Stroke Association updated guidelines for the primary prevention of stroke, emphasizing primary care screening, lifestyle management, and risk factor control.
    • “The guideline, published in Stroke, replaced the 2014 version to guide management for individuals with no prior history of stroke.
    • “This guideline is important because new discoveries have been made since the last update 10 years ago. Understanding which people are at increased risk of a first stroke and providing support to preserve heart and brain health can help prevent a first stroke,” said writing group chair Cheryl Bushnell, MD, MHS, of Wake Forest University School of Medicine in Winston-Salem, North Carolina, in a press release.
  • The Wall Street Journal relates,
    • “Novo Nordisk’s once-daily pill to treat type 2 diabetes has shown it cuts the risk of heart attacks and strokes in patients by up to 14%, according to a new trial.
    • “Rybelsus is an oral form of semaglutide, the active ingredient in the company’s blockbuster Ozempic and Wegovy diabetes and weight-loss drugs, and was tested in the trial on diabetic patients who also suffered from established cardiovascular disease and/or chronic kidney disease.
    • “Approximately one in three adults with type 2 diabetes also have cardiovascular disease; therefore, it is crucial to have therapies that can address both conditions,” said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk.
    • “The company said the drug appeared to have a safe and well-tolerated profile in line with previous oral semaglutide trials and showed it reduces the risk of major cardiovascular events such as cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.
    • “Novo Nordisk expects to file for regulatory approval of a label expansion for Rybelsus in both the U.S. and European Union around the turn of the year.”
  • The American Medical Association lets us know what doctors wish their patients knew about childhood obesity.
  • Consumer Reports discusses urinary tract infections that afflict older folks.
  • The Institute for Clinical and Economic Review published a Final Evidence Report on Treatments for Transthyretin Amyloid Cardiomyopathy.
    • An independent appraisal committee voted that current evidence is adequate to demonstrate superior net health benefits for tafamidis, acoramidis, and vutrisiran when compared to no disease-specific therapy; tafamidis and acoramidis would achieve common thresholds for cost-effectiveness if priced between $13,600 to $39,000 per year.

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Technology giant Amazon is partnering with a high-profile provider to expand its primary care offerings.
    • “Amazon One Medical will collaborate with Cleveland Clinic to open a primary care office in 2025, with plans for additional locations over the next few years, the organizations said Monday.
    • “We’re starting small with a couple of locations, … then we’ll see where it takes us,” said. Dr. Tomislav Mihaljevic, CEO and president at Cleveland Clinic. “We’re continuously evaluating potential partnerships, and this is the one that just rose to the top of what we think is the right thing for our patients.”
    • “Facilities will be staffed by One Medical clinicians. Although walk-in care will be publicly available, only One Medical members will be able to make appointments online or access telehealth, among other services.
    • “The affiliation will enable One Medical members to access specialty care at Cleveland Clinic via patient referrals, the organizations said.”
  • Per MedTech Dive,
    • “Intuitive Surgical is on track to take the da Vinci 5 robot from a limited rollout to a broader launch in mid-2025.
    • “Intuitive placed 110 da Vinci 5 systems in the third quarter, up from 70 in the second quarter, bringing the total installed base to 188, executives said on an earnings call Thursday. Customers so far have completed more than 12,000 procedures with the new platform over about the past six months, they added.
    • “Da Vinci 5 installations are “well ahead of lofty buy-side expectations,” said BTIG analyst Ryan Zimmerman. “Limited launch or not, that’s a lot of [da Vinci 5] demand,” the analyst wrote in a note to clients after the call. BTIG estimated the number of cases completed with da Vinci 5 equals nearly 32 procedures per system per quarter.”

Weekend Update

David Ermer–Congress, Medical / Rx research, Medicare, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

From Washington, DC

  • Congress remains on the campaign trail until the lame duck session begins on November 12.
  • Modern Healthcare reports,
    • “Humana Inc. sued U.S. health agencies seeking to reverse a cut to crucial Medicare quality ratings, linked to billions of dollars in revenue, that sent the company’s stock tumbling this month.
    • “The lawsuit argues that the U.S. Medicare program was “arbitrary and capricious” in how it calculated the metrics for Humana’s health plans. The scores, known as star ratings, are linked to billions in bonus payments in future years.
    • “The case was filed Friday in federal court in the Northern District of Texas before Judge Reed O’Connor, who has frequently ruled in favor of plaintiffs challenging government regulations.” 

From the public health and medical research front,

  • The Washington Post reports,
    • “The simple difference in the genetic code — two X chromosomes vs. one X chromosome and one Y chromosome — can lead to major differences in heart disease. It turns out that these genetic differences that usually distinguish women from men influence more than just sex organs and sex assigned at birth — they fundamentally alter the way cardiovascular disease develops and presents. * * *
    • “Women are more likely to die after a first heart attack or stroke than men. Women are also more likely to have additional or different heart attack symptoms that go beyond chest pain, such as nausea, jaw pain, dizziness and fatigue. It is often difficult to fully disentangle the influences of sex on cardiovascular disease outcomes vs. the influences of gender.
    • “While women who haven’t entered menopause have a lower risk of cardiovascular disease than men, their cardiovascular risk accelerates dramatically after menopause.
    • In addition, if a woman has Type 2 diabetes, her risk of heart attack accelerates to be equivalent to that of men, even if the woman with diabetes has not yet gone through menopause. Further data is needed to better understand differences in cardiovascular disease risk among nonbinary and transgender patients.
    • “Despite these differences, one key thing is the same: Heart attack, stroke and other forms of cardiovascular disease are the leading cause of death for all people, regardless of sex or gender.”
  • STAT News lets us know,
    • “Pascal Geldsetzer and his team looked at nearly 300,000 electronic health records gathered randomly from people born between 1925 and 1942, comparing those on either side of the birthday cut-off date. They found that individuals who received the vaccine, called Zostavax, had a 20% lower risk of later developing dementia. The single shot had no impact on a host of other health outcomes common in older people, including heart disease, lung infections, and cancer. When his team began looking at other places with similar vaccine rollouts, including the U.K. and Australia, they kept finding shingles shots were protecting people’s brains. 
    • “Wherever we look, we see this strong signal,” Geldsetzer said. “We’re looking at a causal effect. And it’s specific to dementia. There is something clearly going on here.”
    • “The idea that viral infections can play a role in at least some dementia cases goes back decades. But it’s still controversial in the Alzheimer’s field, where scientists who raised the possibility have faced frustrating, even career-ending obstacles to pursuing their research. In the last decade though, the connections between pathogens and dementia have been slowly strengthening, as more and more researchers and funders begin to take the idea more seriously. 
    • “Like most fields there is an orthodoxy; in Alzheimer’s disease it’s not infectious agents,” said Paul Harrison, a professor of psychiatry at Oxford University. “But I’ve always viewed it as very intriguing.” * * *
    • “For the past few years, a team Harrison leads has been combing through millions of electronic health records to understand how Covid-19 affects the brain. They’ve published several influential studies showing how rates of mood disorders, strokes, and dementia alarmingly increase following infection, risks that stay elevated for years. Harrison realized he could use this same massive medical database to look for a link between a newer version of the shingles vaccine and dementia incidence. 
    • ‘The results of their analysis of health records from 200,000 Americans, published in Nature Medicine in July, showed that Shingrix — the recombinant shingles vaccine approved in the U.S. in 2017 — decreased the risk of developing dementia in the six years following its approval by 17%, compared to people who’d received Zostavax, an older, less effective shingles shot. Compared to people who’d received shots against other infections (like flu and tetanus), Shingrix vaccination cut dementia risks by up to 25%.”
  • Fortune Well discusses the public health implications of food dyes.

From the U.S. healthcare business front,

  • The Wall Street Journal considers why health insurers keep getting slammed with higher costs.
    • “[W]hat seems to have unnerved investors is how, after consecutive quarters of disappointing results, insurers still don’t seem to have a full understanding of what is going on or when it will improve. Many will choose to wait on the sidelines until the fog clears.”
  • Modern Healthcare notes,
    • “The HLTH 2024 conference kicked off Sunday, Oct. 20, in Las Vegas at the Venetian Expo Center, where all sorts of innovative companies from the healthcare industry will connect to share strategies, network and discuss their thoughts on the future. Speakers and presenters this year include leaders from Kaiser Permanente, Nvidia, Oracle, Walgreens and many more plus special appearances by Dr. Jill Biden, Halle Berry and Lenny Kravitz.”
  • Legal Dive tells us,
    • “Expect to spend twice as long preparing a filing under the Hart-Scott-Rodino merger review process under final guidelines released by the Federal Trade Commission and Department of Justice, an analysis says. 
    • “What typically took about 37 hours to comply with will likely take closer to 70 hours, Freshfields attorneys say in a memo on what in-house counsel can look forward to once the guidelines take effect, slated for mid-January. 
    • “The time, cost, and burden on all filing parties will increase significantly,” the attorneys say in their Oct. 16 analysis. “And [the increased burden] almost certainly underestimates the time required for strategic transactions.”
  • HR Dive informs us,
    • “As the global workforce continues to evolve, talent acquisition and retention will shift toward personalized employee experiences and expectations rather than typical rewards and physical work locations, according to an Oct. 11 report based on EY’s 2024 Work Reimagined Survey.
    • “For instance, 38% of employees said they’re likely to quit in the next year, which will require company flexibility and a plan for talent flow. This means untethered culture, expanded rewards and agile skill building will become more prevalent, the report found.
    • “Previous iterations of this survey showed the lenses through which employers and employees viewed the working world: employers driven mostly by cyclical concerns and employees fueled by structural transformation of how, where and why they work,” EY experts wrote. “Those lenses appear to be fracturing, as old thinking is shown as too rigid to navigate new terrain.”
    • “Instead, organizational success will rely on five dimensions: talent health and flow; work technology and generative AI; total rewards priorities; learning, skills and career pathways; and culture and workplaces. EY calls the combination a “Talent Advantage.”