Tuesday Tidbits

Federal employment benefits

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.”

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.”

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.”

Thursday Miscellany

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Office of Personnel Management tells us,
    • “OPM today released the 2024 OPM Federal Employee Viewpoint Survey (FEVS) results, the largest worldwide survey of government employees that annually tracks how employees view workforce management, policies, and new initiatives. This year’s results show steady improvement in nearly all areas and the highest-ever Employee Engagement Index (EEI) score since OPM began tracking the metric in 2010. The EEI assesses the critical aspects of an engaged workforce including perception of leadership, supervisors, and intrinsic work experience.” * * *
    • “For the full collection of data, see the OPM FEVS dashboard. This tool provides the public with a dynamic way to access and visualize governmentwide and agency-size survey results and trends of the past five years. New content in the 2024 dashboard release features inclusion of results by Federal Executive Board region and will enhance each Board’s ability to address specific challenges within their geographical area.   
    • “For more information on OPM FEVS methods, see the OPM FEVS Technical Report.”   
  • Federal News Network adds,
    • Many federal human capital experts have said receiving the results of FEVS each year is only the first step for long-term workforce planning. To actually make improvements for their employees, experts say agency leaders have to then analyze the FEVS results and make adjustments as necessary. Later this fall, the Chief Human Capital Officers (CHCO) Council plans to publish a FEVS “toolkit” including recommendations for how leaders can make changes based on FEVS, as well as strategies for action planning and better communication with employees.”
  • Tammy Flanagan, writing in Govexec, points out ten important facts about Medicare that folks approach age 65 need to know.
  • Federal News Network is offering a Federal Benefits Open Season feature
  • The American Hospital Association News lets us know,
    • “A report released Oct. 17 by the Senate Homeland Security Committee’s investigative subcommittee scrutinizes some of the nation’s largest Medicare Advantage insurers for their use of prior authorization and high rates of denials for certain types of care. The subcommittee sought documents and information from the three largest MA insurance companies — UnitedHealthcare, Humana and CVS — and investigated their practice of “intentionally using prior authorization to boost profits by targeting costly yet critical stays in post-acute care facilities.”  
    • “The report found that between 2019 and 2022, UHC, Humana and CVS denied prior authorization requests for post-acute care at far higher rates than other types of care. In 2022, UHC and CVS denied prior authorization requests for post-acute care at approximately three times higher than the companies’ overall denial rates, while Humana’s prior authorization denial rate for post-acute care was more than 16 times higher than its overall denial rate. The report also found increases in post-acute care service requests subjected to prior authorization and denial rates for long-term acute care hospitals, among other findings.”
  • In the past, such practices were praised as cost containment, a now forgotten policy.
  • Thompson Reuters delves into “HHS FAQs [that] elaborate on HIPAA Administrative Simplification Enforcement and Compliance.”

From the public health and medical research front,

  • The Washington Post reports the latest news about the ongoing massive meat recall over a Listeria concern.
    • The recalled products include about 11,765,285 pounds of ready-to-eat meat and poultry items [prepared by BrucePac] that have been sold at stores across the country, including Walmart, Target, Aldi, Trader Joe’s, Kroger, Publix, Wegmans and more.
    • Initially, the [USDA Food Safety and Inspection Service] FSIS said the recalled goods have the establishment numbers 51205 or P-51205 inside or under the USDA mark of inspection on their labels, but it cautioned later that some recalled products could bear a different number “due to further distribution and processing by other establishments.”
    • The FSIS is encouraging consumers to review a more than 340-page list of labels and products included in the recall. The list has images of labels with 7-Eleven, Amazon Kitchen, Boston Market, Dole, Taylor Farms, Giant Eagle and ReadyMeals branding, among several other name brands.
    • Among the recalled items are chicken-based salad bowls, wraps, sandwiches, burritos and pastas.
    • In an Oct. 15 update, the FSIS said that the recalled foods had been distributed to schools, in addition to restaurants and institutions, but that a school distribution list was not yet available. “These products should be thrown away or returned to the place of purchase,” it said.
  • The NIH Director Dr. Monica Bertagnolli writes in her blog,
    • “Proteins are vital to our bodies. They serve as structural building blocks for our tissues and organs and are responsible for their functioning in both health and disease. Genes, like recipes, contain instructions for making proteins. Usually, each essential protein is produced from a single gene. Now, new research shows that some bacteria can actually produce two or more proteins from a single gene by “flipping” underlying stretches of DNA.
    • “While scientists have long known that DNA inversions can occur in bacteria, this study is the first to describe these inversions, or “invertons,” within individual genes. What’s more, the findings, from research supported by NIH and reported in the journal Nature , suggest that this flipping happens more often than scientists suspected.
    • “The findings, from Ami S. Bhatt at Stanford Medical School in Stanford, CA, and her colleagues, may have important implications, not only for bacteria, but also for human health. For example, bacteria’s ability to flip genes and alter proteins on their surfaces may restrict the ability of our immune systems to recognize and effectively respond to infectious microbes. Invertons also likely play roles in how our microbiomes, the communities of microorganisms that live in and on us, develop and change within our bodies. Our microbiomes influence our metabolisms, immune responses, and more. * * *
    • “The researchers now want to investigate the mechanisms causing inversions. They expect that these findings are just the tip of the iceberg for understanding the role of invertons in bacteria’s ability to adapt and thrive. They also suggest that, as we learn more about links between this process in bacteria and human diseases, we might find ways to harness it for improving human health.”
  • The Wall Street Journal reports,
    • “Feel like it takes longer to recover from everything these days—whether it’s an injury or poor sleep? That’s the reality of what time is doing to our bodies.
    • “Researchers call our ability to bounce back from health stress “biological resilience.” Evidence suggests that it declines with age, driven by biological and other factors, including parenting, work stress, changes in exercise habits and menopause.
    • “Often, these stresses pile up from early life and can reach a tipping point in our 30s and 40s. 
    • “There are these moments where the whole system seems to undergo like a vibe shift,” says Dr. Heather Whitson, a geriatrician and clinical investigator who directs the Duke University Aging Center.
    • “These midlife declines in resilience parallel emerging science suggesting that aging itself doesn’t happen in a linear way, doctors and researchers say. A small study out of Stanford that looked at biomolecular shifts in the body found two aging “waves” appear to occur around ages 44 and 60. 
    • “While the Stanford study’s findings are difficult to generalize to the broader adult population, family-medicine doctors report seeing similar age-related changes in their patients. The first shift often happens for patients in their late 30s and early 40s, says Dr. Benjamin Missick, family medicine doctor at Novant Health in North Carolina.”
  • and
    • “Drugs such as Novo Nordisk’s blockbuster Ozempic can cut drug and alcohol abuse by up to 50% according to a new study, adding to mounting evidence that the drugs yield health benefits beyond diabetes and weight loss.
    • “In a study published Thursday in scientific journal Addiction, around 500,000 people with a history of opioid use disorder were analyzed, of which just more than 8,000 were taking either GLP-1 drugs such as Ozempic or the similar GIP class of drugs that Eli Lilly’s Mounjaro belongs to.
    • “GLP-1 drugs work by mimicking a gut hormone to control blood sugar and suppress appetite while GIP medications take a dual-target approach by mimicking both the GLP-1 hormone and a second gut hormone that is believed to enhance the drug’s effectiveness.
    • “The study found that those taking the drugs had a 40% lower rate of opioid overdose compared with those who didn’t.
    • “Similarly, an analysis of more than 5,600 people with a history of alcohol use disorder and who took the drugs showed they had a 50% lower rate of intoxication compared with those who didn’t take them.
    • “Our study… reveals the possibilities of a novel therapeutic pathway in substance use treatment,” the study’s lead researcher Fares Qeadan and co-authors of the research report Ashlie McCunn and Benjamin Tingey said.
  • Per BioPharma Dive,
    • “People with advanced Parkinson’s disease have a new treatment option, as the Food and Drug Administration on Thursday approved a combination therapy from AbbVie that’s designed to provide longer-lasting movement control.
    • “Parkinson’s is hallmarked by unintentional muscle movements like shaking or stiffness — the result of nerve cells progressively breaking down and dying. Two drugs, carbidopa and levodopa, have become mainstay treatments for the motor symptoms associated with the disease. AbbVie’s now-approved Vyalev pairs these medications together, but in a unique way.
    • “Vyalev uses “prodrug” versions of carbidopa and levodopa, meaning their therapeutic effects aren’t felt until they’re metabolized. Additionally, Vyalev is the first and only levodopa-based therapy given as a 24-hour infusion, similar to an insulin pump. That could be particularly useful for people with advanced Parkinson’s, who often have trouble swallowing pills because of their impaired motor function.”
  • HCP Live relates,
    • Low-dose oral food challenges in infants with allergies are safe, with skin symptoms as the most common reaction, and no cases of anaphylaxis reported.
    • The study supports early introduction of allergenic foods to build tolerance, aligning with guidelines for early peanut introduction.
  • Beckers Clinical Research notes,
    • “University of Pennsylvania and Children’s Hospital of Philadelphia researchers have developed the first mRNA Clostridioides difficile vaccine — and it’s shown promising results in animal models.
    • “The mRNA vaccine was found to protect against first-time C. diff infections and relapsing infections, promote clearance of existing C. diff bacteria in the gut and overcome deficits in host immunity to protect animals from infection, according to an Oct. 17 system news release. The study was published in Science and could pave the way for clinical trials.
    • “Researchers used the mRNA-LNP vaccine platform — the same that provided the COVID-19 vaccines — to create the C. diff vaccine.” 

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Elevance Health lowered its profit guidance for 2024 on Thursday as the insurer manages “unprecedented challenges” in its Medicaid business.
    • “The company expects net income per diluted share to be approximately $26.50, down from at least $34.05 it projected last quarter. 
    • “But CEO Gail Boudreaux said the increased costs pressuring its Medicaid segment would alleviate as states updated their payment rates to better match member acuity. “We remain confident in the long-term earnings potential of our diverse businesses as we navigate a dynamic operating environment and unprecedented challenges in the Medicaid business,” she said in a statement.” 
  • Modern Healthcare adds
    • “Elevance Health took a hit on its Medicare Advantage star ratings for 2025 and plans to do something about it, President and CEO Gail Boudreaux told investor analysts Thursday.
    • “The for-profit Blue Cross and Blue Shield licensee is the latest Medicare Advantage insurer to push back on the lower quality scores the Centers for Medicare and Medicaid Services announced last week. UnitedHealthcare parent company UnitedHealth Group already sued the agency and Humana is appealing to CMS before taking other actions.
    • “We have challenged our initial score with CMS and are considering all of our options,” Boudreaux said when announcing the company’s third-quarter financial results.”
  • Fierce Healthcare tells us,
    • “Evernorth has tapped Transcarent to power its Oncology Benefit Services offering, which aims to offer end-to-end support for cancer patients for the course of their care journey.
    • “The companies announced Thursday that the program is built on a digital platform that unites key cancer services across the patients’ medical and pharmacy benefits and connects them to a dedicated care team for personalized support and outreach.
    • “This digital platform makes it easier for employers to offer a “streamlined” experience to workers, according to the announcement. Through it, members can reach dedicated oncology nurse navigators who have an American Cancer Society Leadership in Oncology Navigation (ACS LION) certification, find and schedule appointments with cancer centers of excellence, connect to virtual care or have key drug consultations.
    • “Nurse navigators are also trained to provide support to the patients’ caregivers. They’re able to provide educational materials, assistance in appointment scheduling and answers to key questions.”
  • Beckers Hospital Review points out,
    • “Changing consumer trends and market dynamics are leading to hundreds of pharmacy store closures in the U.S.
    • “Brick-and-mortar locations are losing to mail-order and digital options, according to a J.D. Power study of pharmacy customers. Between 2023 and 2024, overall customer satisfaction in physical drug stores declined 10 points on a 1,000-point scale, and satisfaction scores for mail-order pharmacies increased six points.” 
  • “Deloitte research indicates that by ensuring virtual health offerings prioritize convenience and address consumer preferences, health systems could gain a competitive advantage.”
  • Per MedTech Dive,
    • “CMR Surgical won Food and Drug Administration authorization for its Versius robot with an initial indication for gallbladder removal surgery. CMR will partner with select hospitals as the first part of a multistage strategic plan to introduce the robot in the U.S.
    • “The authorization is the first granted through the FDA’s de novo pathway for a multiport, soft tissue general surgical robot, CMR said in a Monday announcement. The de novo process brings new medical devices to market that may serve as predicates for other 510(k) submissions.
    • “The company announced the milestone less than a week after it named Massimiliano Colella as interim CEO, replacing Supratim Bose, who stepped down for personal reasons after less than two years in the job.” 

Midweek Update

David Ermer–ACA, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, SDOH, U.S. Healthcare–

From Washington, DC

  • CBS News lets us know,
    • “The Biden administration says it has invoked the wartime powers of the Defense Production Act to speed rebuilding of a major American factory of intravenous fluids that was wrecked by Hurricane Helene last month. Damage to the plant in North Carolina has worsened a nationwide shortage of IV fluids, and hospitals say they are still postponing some surgeries and other procedures as a result. 
    • “Some 60% of the nation’s IV supplies had relied on production from the plant, run by medical supplier Baxter, before it was damaged by the storm.”
  • CMS released its “Final 2026 Actuarial Value Calculator Methodology.”
  • CMS announced,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), approved section 1115 demonstration amendments that allow, for the first time ever, Medicaid and Children’s Health Insurance Program (CHIP) coverage of traditional health care practices provided by Indian Health Service (IHS) facilities, Tribal facilities, and urban Indian organizations (UIO). Today’s action is expected to improve access to culturally appropriate health care and improve the quality of care and health outcomes for tribal communities in Arizona, California, New Mexico, and Oregon, and will support IHS, Tribal, and UIO facilities in serving their patients. 
    • “Traditional health care practices have been a way of life in many communities. And they are extremely important for American Indian and Alaska Native populations,” said HHS Secretary Xavier Becerra. “But, too often, health insurance does not cover them. With Medicaid and CHIP’s inclusion of traditional health care practices at certain IHS facilities, we are extending access to culturally appropriate, quality health care in Tribal communities.”
  • The Wall Street Journal reports,
    • “Novavax said federal regulators put a clinical hold on its application for a combination Covid-19 and influenza vaccine and stand-alone flu inoculation, sending shares down sharply.
    • “The vaccine maker on Wednesday said the Food and Drug Administration placed the hold because of a report of a “serious adverse event” of motor neuropathy in one clinical-trial participant outside the U.S., who received the vaccine in January of 2023.
    • “This participant was part of a Phase 2 trial for the combination vaccine that was completed in July 2023 and reported the adverse event in September of this year, the Gaithersburg, Md., company said.
    • “While we do not believe causality has been established for this serious adverse event, we are committed to working expeditiously to fulfill requests for more information from the FDA,” Novavax Chief Medical Officer Robert Walker said. “Our goal is to successfully resolve this matter and to start our Phase 3 trial as soon as possible.”
  • Reg Jones, writing in FedWeek, explains how court orders can impact federal retirement benefits.

From the public health and medical research front,

  • The Wall Street Journal tells us
    • “Frozen shoulder, a painful condition that immobilizes the shoulder joint, tends to strike midlife women.
    • “Treatments for frozen shoulder include steroid injections and physical therapy.
    • “Preliminary data suggests that hormone therapy might help prevent frozen shoulder in midlife women.”
  • and
    • “Scientists hope body tissues grown in labs will become a familiar sight in medicine. 
    • “Researchers around the world are working to grow heart valves, lungs and more from human cells. They have succeeded in bringing some to market such as knee cartilage and skin grafts, but advances for more complicated anatomy have been slow-going for years. 
    • “Now scientists are gaining ground in tissue engineering that could help a host of people who deal with circulatory-system problems.”
  • The American Medical Association offers “four steps to care for patients with prolonged symptoms of Lyme disease.”
  • BioPharma Dive notes,
    • “The Food and Drug Administration on Tuesday approved a new device to treat non-small cell lung cancer, Novocure’s Optune Lua, which creates electric fields that its manufacturer says disrupts malignant cell division. The FDA cleared the device for use with immunotherapy or chemotherapy in people whose cancer has spread and progressed following chemo.
    • “Approval was based on results from “Lunar,” a Phase 3 trial in which people who used the device with standard therapies had a 26% reduced risk of death over a median follow up of around 10 months. The results were controversial, however, because the trial included concurrent care with immunotherapies, which are typically used as a first-line treatment, as well as chemo.”
  • Per MedPage Today,
    • The long-term risk of distant recurrence for women with early breast cancer has declined significantly, a decades-long analysis of clinical trial data showed, largely a result of patients enrolling with lower-risk disease along with improved adjuvant therapy.
  • KFF discusses how “More Mobile Clinics Are Bringing Long-Acting Birth Control to Rural Areas.”
  • Per Health Day,
    • “Most Americans 50 and older don’t place much trust in health advice generated by artificial intelligence, a new survey finds.
    • “About 74% of middle-aged and senior Americans would have very little to no trust in health info generated by AI, the University of Michigan poll found.
    • “At the same time, these older adults have a lot of confidence in their ability to suss out bad info about health matters.
    • “Only 20% said they had little to no confidence they could spot misinformation about a health topic if they came across it.
    • “Among all older adults who’d scanned the web recently for health info, only 32% said it’s very easy to find accurate advice.
    • “Amid this lack of trust, our findings also highlight the key role that health care providers and pharmacists play as trusted health messengers in older adults’ lives, and even the role that friends or family with medical backgrounds can play,” said poll director Dr. Jeffrey Kullgren, an associate professor of internal medicine at the University of Michigan.”

From the U.S. healthcare business front,

  • Fierce Healthcare alerts us that U.S. News and World Report has released its Medicare Advantage and Part D plan ratings.
  • Beckers Hospital Review reports,
    • “UnitedHealth Group is seeing “unusually aggressive and high unit cost asks” from hospitals, CEO Andrew Witty said. 
    • “On an Oct. 15 call with investors, Mr. Witty said UnitedHealth wants to find a “new way of working with hospitals.” 
    • “We want to see less abrasion in the marketplace,” Mr. Witty said. “We believe that ought to come with more competitive rates in the marketplace.” 
    • “UnitedHealth reported its third-quarter earnings Oct. 15. CFO John Rex said medical costs rose in the third quarter, driven by increased pharmacy costs, Medicaid rates and an increase in coding intensity by hospitals.” * * *
    • “Mr. Witty told investors UnitedHealth wants to collaborate with hospitals to drive better value for the healthcare system. The company’s newly launched gold card program, which relaxes prior authorization requirements for some providers, is one example of this collaboration, Mr. Witty said. 
    • “The company is also seeking out partnerships with drug manufacturers to bring down prescription spending, Mr. Witty said. 
    • “Whether that be with drug companies that are interested in new ways of working to bring down costs, or whether that’s with hospital systems who want to work with us to reimagine what the patient experience, what the doctor experience is — [that’s] all part of bringing down the unit cost. Those are areas that are super important for the long run,” Mr. Witty said.” 
  • Per Fierce Pharma,
    • “With Gilead Sciences sprinting to a likely approval next year for its long-acting pre-exposure prophylaxis (PrEP) drug for HIV, the California company has a chance to one-up GSK. While the British company’s long-acting Apretude is injected every two months, Gilead’s answer is dosed just twice a year.
    • “Later this decade, GSK hopes to launch PrEP options that have four and six months of staying power. But, until then, it will do battle with Apretude (cabotegravir long-acting), which has just excelled in several real-world studies.
    • “In two real-world evidence studies of nearly 1,300 people, Apretude has shown better than 99% effectiveness in preventing HIV infections. GSK’s ViiV Healthcare unit also presented findings from the PILLAR implementation study, which show reductions in stigma and anxiety among users of the treatment. The new results are being presented Wednesday through Saturday in Los Angeles during IDWeek 2024.
    • “The results add to the positive momentum for Apretude, which was approved in December 2021 as the first long-acting PrEP option for HIV. The drug offers an alternative to daily pills such as Gilead’s Truvada and its follow-on Descovy.”
  • Investing.com relates,
    • “Aetna, a CVS Health company (NYSE: NYSE:CVS), has introduced a new health plan option called SimplePay Health, aimed at self-insured customers to potentially lower health care costs, enhance health outcomes, and streamline the health care experience. This plan offers a unique payment approach and tools for selecting high-quality health care providers.
    • “SimplePay Health, which is part of Aetna’s expanding portfolio, is designed to offer price certainty and simplicity for members. It features a copay-only structure with no deductibles or coinsurance, providing members with clear cost information for services prior to visits or treatments. The copay encompasses all aspects of a service, such as hospital visits or specialty services like labs.
    • “The plan claims to have resulted in a 60 percent increase in the use of top-quality providers and a 12 percent reduction in total care costs for employers and members. Members are equipped with an app to find providers based on cost and outcome quality, and they receive a single monthly statement summarizing all medical and pharmacy claims, similar to a credit card statement but with no interest and no payment due at the time of service.
    • “Aetna asserts that SimplePay Health enhances the overall health care experience by offering transparent cost insights and quality information to aid members in making informed decisions. Additionally, the plan includes a 0% interest rate line of credit benefit for paying balances, which is integrated into the medical plan.”

Monday Roundup

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, Medicare, Obesity, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • BioPharma Dive lets us know,
    • “The Food and Drug Administration has temporarily deflected a lawsuit alleging it violated federal law by removing Eli Lilly’s obesity and diabetes drugs Zepbound and Mounjaro from an agency shortage list. But in the process, the regulator agreed to evaluate objections from the companies selling compounded copycats of Lilly’s fast-selling medicines.
    • “A ruling issued Friday in the U.S. District Court for the Northern District of Texas permits the makers of compounded versions of tirzepatide, the active ingredient in Zepbound and Mounjaro, to temporarily keep selling their medicines. In the meantime, the FDA and a group of compounders, led by a trade group called the Outsourcing Facilities Association, will continue negotiations. They will file a status report on Nov. 21, according to court documents.
    • “The decision is the latest twist in a saga over the supply of so-called GLP-1 medicines like Zepbound, Mounjaro and Novo Nordisk’s Wegovy, which can help people quickly lose weight. Demand for the medicines has been so strong it’s outstripped supply, leading to manufacturing shortages that have made it possible for direct-to-consumer companies to step in and offer compounded alternatives.”
  • The National Academies of Science tells us,
    • “Most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences, the 2015 National Academies report Improving Diagnosis in Health Care found. Diagnostic errors are a contributing factor in approximately 10 percent of patient deaths.
    • “A recent workshop hosted by the National Academies explored some of the potential benefits and risks involved in using artificial intelligence and other digital tools to improve medical diagnoses.
    • “Daniel Yang, vice president of AI and emerging technologies at Kaiser Permanente and chair of the workshop planning committee, noted that his current role and his prior work in philanthropy have given him a front-row seat to witness “both the incredible opportunity and the perils of applying new technology to diagnosis.”
  • Kevin Moss writing in Federal News Network advises federal and postal employees and annuitants to “Choose wisely: Not all healthcare premiums are increasing.” Mr. Moss notes “Health plan premiums will rise by an average of 13.5% next year, marking the largest increase in recent memory.” The 13.5% increase is overstated because it assumes no enrollment changes occur in Open Season.
    • For 2025, 20% of the enrollment is moving to the PSHB Program which has somewhat lower premiums. It also should be understood that FEHB premiums have been increasing because OPM required FEHB carriers to cover GLP-1 drugs for obesity in January 2023 without any advance notice. At that point, FEHB plans could not raise their premiums for almost 12 months.
    • This expensive decision came on top of healthcare cost inflation which has afflicted the economy since 2022. While OPM did allow carriers to offer Part D EGWPs for 2024, relatively large cadres opted out which lowered the new savings. Fortunately, the number of opt outs should decrease for 2025 due to the attractive, expanded Part D 2025 benefit package.
  • Bloomberg reports,
    • “Blue Cross Blue Shield agreed Monday to pay $2.8 billion to resolve antitrust claims alleging hospitals, physician groups, and other healthcare providers were shortchanged on reimbursements.
    • “The payment is the largest in a healthcare antitrust case, the healthcare providers say in their motion for preliminary approval. In addition to the funds, the settlement provides for reforms to Blue Cross’s BlueCard program, which is the company’s system of electronic claims processing for providers throughout the US and abroad. * * *
    • “Blue Cross said in a statement Monday that “we deny the allegations made in the lawsuit. However, to reach a settlement and put years of litigation behind us, we have agreed to make some operational changes and a monetary payment to the provider class involved in the case.”
    • “The case is In Re Blue Cross Blue Shield Antitrust Litigation , N.D. Ala., No. 2:13-cv-20000, motion for preliminary approval 10/14/24.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Children and teenagers infected with the coronavirus are significantly more likely to develop Type 2 diabetes than their peers afflicted with other respiratory illnesses, according to research published Monday.
    • “As the public heads into another viral season, health experts said the findings highlight how the virus continues to reveal new ways to pose detrimental long-term consequences.
    • “Children were 50 percent more likely to be diagnosed with diabetes at the six-month mark if they had endured a coronavirus infection compared with children who had another respiratory infection, according to findings published in JAMA Network Open.
    • “The subset of patients in the study who were obese were 100 percent more likely to have a Type 2 diabetes diagnosis compared with their peers beset with other respiratory infections.”
  • STAT News informs us,
    • “When the U.S. health care system pivoted to meet Covid-19 in 2020, routine health visits and screenings where many cancer cases would have been caught didn’t happen. It wasn’t ideal, but many health experts thought that as the country opened back up, screenings would help “catch up” to these missed cases. A new paper published Monday in JAMA Network Open suggests that didn’t happen as quickly as experts had hoped.
    • “Instead, the new analysis suggests that cancer diagnoses recovered to pre-pandemic levels by the end of 2021 — but didn’t make up for any of the lost cases from earlier in the pandemic. That leaves a troubling mystery for epidemiologists, as it means experts still don’t know what happened with the roughly 130,000 cancer cases that were missed in 2020.
    • “It’s still an unwritten story as to what exactly is going on,” said Uriel Kim, a population health scientist at Case Western Reserve University and the lead author on the study.”
  • Per Beckers Hospital Review,
    • Effective Sept. 10, the FDA required healthcare facilities providing breast imaging services to notify patients of their breast density in mammography reports. Now, some experts are expressing concern over the new mandate, according to an Oct. 12 report from NBC News. 
    • The majority of concerns stem from the lack of guidance over how to proceed once a patient has been identified as having dense breasts, particularly recommendations on additional imaging procedures. 
    • “You cannot counsel an entire population of women with dense breasts with one policy that’s going to be appropriate for everybody,” Mark Pearlman, MD, emeritus professor at Ann Arbor-based University of Michigan Medical School, told NBC News.
  • The American Medical Association lets us know what doctors wish their patients knew about ADHD in children.
  • Per Healio,
    • “Researchers observed an increase in heart rate and atrial tachycardias as alcohol consumption increased in young adults.
    • “Some participants experienced notable arrhythmia episodes including atrial fibrillation.”
  • MedPage Today notes,
    • “More than $100 million could be saved annually on discarded lecanemab (Leqembi), a simulation study suggested.
    • “Current vial sizes may result in 5.8% of the Alzheimer’s disease drug being thrown away, representing $1,619 in wasted Medicare spending per patient per year, reported researchers led by John Mafi, MD, MPH, of the David Geffen School of Medicine at UCLA.
    • “This translates to an estimated $133 million to $336 million worth of lecanemab discarded every year, assuming uptake rates of 1.1% to 2.9%, Mafi and co-authors said in a JAMA Internal Medicine research letter.”
  • Consumer Reports, writing in the Washington Post, advises year-round use of sunscreen products by adults.
    • “You’ve probably heard that the sun does most of its dirty work on our skin when we’re children. Even though that myth was debunked decades ago, the idea persists. That may be why only 57 percent of people 55 and older use sunscreen when they’re in the sun, according to a March CR nationally representative survey of 2,000 U.S. adults. And 14 percent of older adults don’t take any steps to protect their skin from the sun.
    • “That’s a mistake. “Sun damage is cumulative,” says Henry Lim, a dermatologist at Henry Ford Health in Detroit. “If you continue to expose your skin to the sun’s ultraviolet rays, the damage will continue — no matter what age you are.”
    • “Taking action now can help protect your skin from further harm and possibly even reverse some damage. The first step: finding an effective sunscreen, one you don’t mind wearing every day.”

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “Hospitals across the United States are reeling from a shortage of IV fluids after Hurricane Helene struck a major manufacturing plant in North Carolina, prompting some to postpone elective surgeries and others to conserve supply by restricting use.
    • “The Food and Drug Administration formally declared a shortage for three fluid products Friday, allowing some hospitals and facilities to manufacture their own supply. The FDA last week had allowed shipments of IV fluids from other countries. But complications make it difficult to immediately end the shortage.
    • “Compounding facilities that typically don’t manufacture IV fluids need access to sterile water and supplies such as bags to make their own products. The American Hospital Association estimates less than a fifth of hospitals are able to do so.
    • “If you turn off a hospital supply of IV fluids, it’s like turning off the water supply to your house,” Chris DeRienzo, the hospital association’s chief physician executive, said. “We need to have a continuous, consistent flow to the hospitals, especially as we are walking into the winter respiratory virus season.”
  • The American Hospital Association News adds,
    • “As part of its regular updates on the IV solution supply disruption as a result of the temporary closure of a manufacturing plant in North Carolina, Baxter Oct. 14 launched a new webpage with resources that hospitals can use for product management and conservation strategies. The webpage contains resources from Baxter, the federal government and other groups. In addition, Baxter said shipments to the U.S. from two Baxter sites abroad that were already able to export products “started last week and more are on the way.” The AHA is continuing efforts on multiple fronts to provide updates and assist members related to the supply chain issues caused by damage from Hurricane Helene.
  • Beckers Payer Issues ranks payers by average Medicare Stars scores.
  • WTW explains why the annual enrollment period / open season is a perfect opportunity to build a more resilient workforce.
  • STAT News tells us,
    • “Biotech investors have been buzzing around new areas of drug development this year, such as the red-hot obesity market. But there’s one field that has seen an even more significant amount of activity: autoimmune diseases.
    • “Companies that are developing new medicines for autoimmune conditions, as well as other immune system disorders, have brought in more money and closed more deals so far this year than most other areas, including the cardiometabolic field, data from investment bank Oppenheimer show. (Oncology remains king when it comes to investment, driven in part by interest in new approaches like radiopharmaceuticals).
    • “In the first half of 2024, venture capitalists pledged more than $1.7 billion to companies developing treatments for conditions in which the body’s own immune system goes haywire, attacking healthy cells and tissues and causing widespread damage. If the trend continues, autoimmune companies could raise double the amount of money that they raised at the height of the biotech market in 2021, according to data compiled by HSBC.
    • “Ask investors why, and most will point to research that’s come out of a German academic laboratory in the last two years, showing that a treatment called CAR-T can potentially reset the immune system in patients with lupus and other conditions.  
    • “That was revolutionary in the field, because … it was unexpected data that no one had ever seen,” said Arjun Goyal, managing director at Vida Ventures. Others described it as an earthquake that shook people to attention. One executive told STAT that his wife, a rheumatologist specializing in lupus, commented that the research could put her out of work.”
  • Per MedTech Dive,
    • “Danish drugmaker Lundbeck has agreed to spend $2.6 billion acquiring a young biotechnology company with an experimental brain medicine that could become a blockbuster product.
    • “The acquisition, announced Monday, has Lundbeck paying $60 in cash for each outstanding share of Longboard Pharmaceuticals, a 54% premium to the biotech’s stock price Friday. The companies expect their deal to close before the end of the year.
    • “Should it go through, the deal would hand Lundbeck a possible treatment for a series of rare brain disorders characterized by seizures and developmental delays. There are more than 20 types of these disorders, known as developmental and epileptic encephalopathies, or DEEs. And according to Lundbeck, they affect around 220,000 people in the U.S., half of whom don’t have an approved therapy to try.
    • “Lundbeck thinks the answer to that problem lies in a Longboard drug called bexicaserin. The drug entered late-stage clinical testing last monthfor one of the more prominent DEEs, Dravet syndrome, and is also being evaluated against another, Lennox-Gastaut syndrome. But Lundbeck believes it has the ability to address all DEEs and estimates the peak annual sales potential could reach $1.5 billion to $2 billion.”

Friday Factoids

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, HSA, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare, Uncategorized–
  • Govexec observes “The Office of Personnel Management’s inspector general last month reported that the federal government’s dedicated HR agency faces taller tasks in the form of launching a health insurance program for postal workers and verifying enrollees’ eligibility for the Federal Employees Health Benefits Program.”
  • While Govexec accurately reflects the substance of the OIG’s report, the FEHBlog disagrees with the OIG conclusions for the following reasons —
    • The OIG and GAO focus on family member eligibility issues. FEHB carriers, or their underwriters, hold the FEHB Program’s insurance risk. The biggest eligibility issue is that OPM does not use the HIPAA 820 enrollment roster transaction which would allow carriers to electronically reconcile individual enrollees with the premiums. This remains a yawning internal gap for the FEHBP.
    • OPM intelligently is assigning Postal employees and annuitants to their appropriate PSHB plan this month. OPM is electronically notifying carriers about these enrollments and OPM is mailing notices to these folks about their enrollments which can be changed during Open Season. If OPM’s new enrollment system breaks down (see healthcare.gov in 2013), the FEHBlog is certain that OPM has a Plan B for making PSHB enrollment change. In the FEHBlog’s view, OPM’s plan provides a high likelihood that the PSHB will timely launch on January 1, 2025.
  • Sequoia reminds us,
    • “The Centers for Medicare and Medicaid Services (CMS) issued Final Rules on how and when civil monetary penalties may be imposed when Responsible Reporting Entities (RREs) fail to meet their Medicare Secondary Payer (MSP) reporting obligations.
    • “Under MSP rules, group health plans are required to submit certain information to CMS on plan participants that are dual enrolled in the group health plan and Medicare. By doing so, CMS can better identify when another party should pay primary, thereby avoiding unnecessary claims payment mistakes.
    • “Generally, a group health plan RRE is the insurer for fully insured plans and the third-party administrator (TPA) for self-funded plans. Employers are not likely to be an RRE, or otherwise have direct reporting obligations, unless as plan administrator they both self-fund and self-administer the plan. However, employers will need to provide any required information requested by the RRE (i.e., insurer or TPA) for them to accurately submit the reporting on the employer’s group health plan to CMS.
    • “Penalties against an RRE are up to $1,000 (as adjusted) per instance of noncompliance for each calendar day that a record is late, with a maximum annual penalty of $365,000 per instance. Penalties may be waived if RREs can show “good faith efforts” to report any records identified by CMS as being noncompliant. Also, CMS will apply a five-year statute of limitations on assessing civil monetary penalties for violations of mandatory reporting requirements.”
    • Important Dates
      • December 11, 2023: Effective date for the Final Rules.
      • October 11, 2024 / TODAY: Earliest date the provisions of the Final Rules will be applied.
      • October 11, 2025: Start date for compliance review and penalty enforcement.
      • April 1, 2026: CMS begins quarterly compliance audit; reviewing a random sample of 250 new records per quarter for a total of 1,000 records per year.
  • Bloomberg lets us know,
    • “Medicare patients changed to outpatient “observation status” after they were initially hospitalized now have a chance to appeal their reclassification under a rule finalized by the Biden administration on Friday. 
    • “The rule (RIN 0938-AV16) would implement a 2020 ruling by the US District Court for the District of Connecticut in a class action involving a dispute over Medicare’s obligation to pay for hospitalizations and long-term care for elderly patients.”
  • The Wall Street Journal reports,
    • “Teva Pharmaceuticals will pay $450 million to resolve allegations that the generic drug manufacturer submitted false claims and violated a federal law that prohibits the payment of kickbacks to generate federal healthcare business or induce patient referrals.
    • “The Justice Department on Thursday said the settlement amount was based on the company’s, whose U.S. headquarters is in Parsippany, N.J., ability to pay. As part of the settlement, there was no admission of wrongdoing on Teva’s part.
    • ‘Teva said it is pleased to put these matters in the past in order to focus on developing and providing access to medicines for patients who need them.”
  • The American Hospital Association News points out,
    • A survey released Oct. 9 and funded by the American Foundation for Suicide Prevention, the Suicide Prevention Resource Center and the National Action Alliance for Suicide Prevention, a public-private partnership whose members include the AHA, shows 63% of U.S. adults are aware of the 988 Suicide and Crisis Lifeline, a 6% increase from 2022. The survey also found that 71% of adults feel comfortable contacting a mental health hotline, while 15% said they have used one previously. Among other findings, 91% of U.S. adults perceive mental health as equal to or more important than physical health, but 49% feel that physical health is treated as more important.

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “COVID-19 activity is declining in most areas. Seasonal influenza is low nationally. Signs of increased RSV activity have been detected in the southeastern United States, including Florida, particularly 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.
      • “The new XEC variant is estimated to comprise 7-16% among circulating viruses as of October 12, 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 remains low. However, continuing signs of increased RSV activity have been detected in the southeastern United States, including Florida, particularly in young children.
    • “Vaccination
      • “Vaccinations to prevent fall respiratory viruses have started for the 2024-25 fall and winter virus season. RSV, influenza, and COVID-19 vaccines are available to provide protection.
  • The University of Minnesota’s CIDRAP tells us,
    • “The California Department of Public Health (CDPH) reported today that the US Centers for Disease Control and Prevention (CDC) has confirmed two of its latest probable H5 avian flu cases, as it reported another likely case based on state testing, which if confirmed would raise the state’s total to seven.
    • “California’s flurry of human cases is occurring amid an ongoing surge of outbreaks affecting the state’s dairy farms, which are concentrated in the Central Valley. Also today, the CDC shared the latest findings from genetic sequencing, which so far show no worrying changes.”
  • and
    • “Genetic sequencing has identified a second cluster of tecovirimat-resistant mpox infections in the United States—the first of its kind involving interstate spread. Researchers from the US Centers for Disease Control and Prevention (CDC) and partners from five affected states reported their findings yesterday in Morbidity and Mortality Weekly Report.
    • “The first Tpoxx-resistant cluster was identified in California in late 2022 and early 2023 in people who hadn’t previously been treated with the drug. The new report describes a new unrelated cluster among 18 people with no previous treatment across multiple states. * * *
    • “In vitro testing of seven samples showed resistance to Tpoxx. Whole-genome sequencing showed that the resistance mutations came from a common ancestor but were distinct from the earlier California cluster.
    • “Researchers said because not all viruses from mpox cases are sequenced, the findings likely underestimate the prevalence of the newly identified drug-resistant variant. They added that more surveillance is needed, as well as adherence to CDC Tpoxx use protocols. Also, they wrote that the findings underscore the need for more treatments for mpox, along with smallpox biothreat preparedness.”
  • Reuters reports,
    • “Roughly 15.5 million U.S. adults have attention-deficit hyperactivity disorder, and most of them struggle with gaining access to treatment for the condition, according to data from a U.S. study released on Thursday.
    • “Only about one-third of those reporting a diagnosis of ADHD said they had received a prescription for a stimulant drug used to treat it in the previous year, researchers reported in the U.S. Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.
    • “In addition, nearly three quarters of those with a prescription for a stimulant drug reported difficulty getting it filled because the medication was unavailable.
    • “Worldwide, around 2% to 5% of adults experience ADHD symptoms such as inattention, hyperactivity, and impulsivity. This study provides the first prevalence data on ADHD in U.S. adults since 2003.”
  • The Wall Street Journal informs us,
    • “The Food and Drug Administration approved Pfizer’s Hympavzi to prevent or reduce bleeding episodes in patients with certain kinds of hemophilia, the pharmaceutical company said.
    • “The approval is for patients with hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) without factor IX inhibitors, Pfizer said Friday.
    • “Hympavzi, also known as marstacimab, can be given subcutaneously every week for routine prophylaxis in patients aged 12 and up as an alternative to intravenous infusions that are often administered multiple times a week, Pfizer said.
    • “The FDA said the drug is the first non-factor and once-weekly treatment for hemophilia B. The agency said the approval provides “a new treatment option that is the first of its kind to work by targeting a protein in the blood clotting process.”
  • BioPharma Dive adds,
    • “The Food and Drug Administration on Thursday approved a new Roche drug for breast cancer. Called Itovebi, the drug has been cleared for use with Pfizer’s Ibrance and endocrine therapy in people whose HR-positive, HER2-negative breast tumors have a mutation called PIK3CA.
    • It’ll compete for market share with Novartis’ Piqray, another medicine targeting PIK3CA mutations. Itovebi is one of five drugs Roche aims to add to its portfolio of breast cancer treatments, which already includes the targeted therapies Herceptin, Perjeta and Kadcyla. 
  • Per Health Day,
    • “It’s never too late for a person to quit smoking, even if they’re elderly, a new study finds.
    • “Dropping the smokes even as late as 75 can meaningfully increase a person’s life expectancy, researchers reported recently in the American Journal of Preventive Medicine.
    • “Seniors aged 75 will lose on average more than four years of life if they keep smoking, compared to people who never smoked, researchers found.
    • “On the other hand, a 75-year-old smoker who quits has a 14% chance of gaining at least one extra year of life, and a 65-year-old smoker a 23% chance.
    • “And about 8% of those who quit at age 75 gain at least four years of life compared to those who keep smoking, researchers found.
    • “Quitting smoking is the single best thing anyone at any age can do to increase their life expectancy, researchers concluded.”

From the U.S. healthcare business front,

  • MedTech Dive relates,
    • “Fresenius Medical Care said Thursday it will increase its production of IV fluid and peritoneal dialysis (PD) products as the U.S. manages shortages due to Hurricane Helene’s effect on the supply chain.
    • “The company is maximizing production capacity at its international sites to help add supply amid an industrywide supply shortage of PD products and IV fluids, according to the update. Fresenius Medical Care is also exploring other options to address the shortage at the Department of Health and Human Services’ request.”
  • Beckers Payer Issues offer new payer game plans for improving women’s health.
  • Fierce Healthcare provides details on the latest Medicare Advantage star scores.
  • Modern Healthcare notes,
    • “Mary Beth Jenkins will become the president and CEO of University of Pittsburgh Medical Center Health Plan starting Jan. 1. 
    • “Jenkins was also named president of UPMC Insurance Services Division and an executive vice president of the system. She will succeed Diane Holder, who plans to retire Dec. 31 after 40 years with UPMC.
    • “Jenkins has been executive vice president of UPMC Insurance Services Division and chief operating officer of UPMC Health Plan since 2023. She joined Pittsburgh-based UPMC in 1998.” 
  • Optum offers HSA plans tips on personalized member communications strategies.

Thursday Miscellany

David Ermer–CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

In hurricane news,

  • The New York Times reports,
    • “The Daytona Beach plant that makes nearly a quarter of the IV fluids used in the United States is intact in the wake of Hurricane Milton’s tear across Florida, according to a company spokeswoman.
    • “The site, operated by B Braun Medical, gained prominence this week as a backup source for IV solutions because Hurricane Helene had flooded a major producer of the fluids in North Carolina and left hospitals from California to Virginia with diminishing supplies.
    • “Company workers and officials from the federal Administration for Strategic Preparedness and Response took pre-emptive measures before Milton arrived, loading trucks full of finished IV medical products to ship them out of the storm’s reach through the night Tuesday. 
    • “Allison Longenhagen, a company spokeswoman, said on Thursday that the manufacturing and distribution site at Daytona Beach was intact, and would reopen on Friday.”
  • Healthcare Dive adds,
    • Hurricane Milton hit Florida’s West Coast hard Wednesday night as a Category 3 storm, bringing torrents of rain and tornadoes that caused millions to lose power and triggered widespread destruction to roads and water and sewage services.
    • While the region’s hospitals were largely ready for storm due to legacy hurricane preparations, health systems are still grappling with critical infrastructure outages and are making “hour-by-hour” calculations on whether to evacuate more patients, according to Mary Mayhew, CEO and president of the Florida Hospital Association.
  • Per MedTech Dive,
    • “Baxter said Wednesday it would increase allocation levels of certain IV fluids as the U.S. manages supply shortages after the company’s largest manufacturing plant was damaged by Hurricane Helene.
    • “The company increased allocation levels of its “highest demand” IV fluids from 40% to 60% for direct customers and from 10% to 60% for distributors, effective Wednesday, according to the update. Baxter also increased the allocation level of IV solutions and nutrition products for designated children’s hospitals to 100%.
    • “Baxter said its goal is to restart production at the North Carolina facility in phases and “return to 90% to 100% allocation of certain IV solution product codes by the end of 2024.”

From Washington, DC,

  • Fierce Healthcare lets us know,
    • “Just 40% of Medicare Advantage prescription drug plans offered in 2025 achieved a score of four stars or higher, the Centers for Medicare & Medicaid Services (CMS) revealed Oct. 10.
    • “It is the third consecutive year the portion of MA plans offering four-star plans or greater decreased, with 68% of plans meeting the threshold in 2022. Last year 42% of plans achieved at least a four-star rating.
    • “Weighted by enrollment, 62% of enrollees are currently in contracts with a four-star rating or better. In 2022, 90% of enrollees were in at least a four-star plan.
    • “These star ratings impact the 2026-year quality bonus payments, which has significant financial repercussions to MA plans. They are rated on 40 measures in Medicare Advantage Prescription Drug (MA-PD) plans, 30 measures for MA plans and only 12 measures in solely prescription drug plans.
  • Federal News Network tells us,
    • “The final piece of the puzzle fell into place Thursday morning for calculating the 2025 cost-of-living adjustment (COLA) for Social Security and federal retirement benefits.
    • “Starting in January, many federal retirees will see a 2025 COLA of 2.5% added to their Social Security benefits and federal retirement annuities — but not everyone will receive the full adjustment.
    • “Retirees in the Federal Employees Retirement System (FERS) usually receive a smaller cost-of-living adjustment each year for their annuities, though the exact difference depends on how big the COLA is in a given year:
      • “COLA is over 3%: FERS annuitants receive 1% less than the full COLA
      • “COLA is between 2% and 3%: FERS annuitants receive a 2% COLA
      • “COLA is less than 2%: FERS annuitants receive the full COLA
    • For 2025, based on those specifications, FERS retirees will receive a “diet” 2025 COLA of 2% for their retirement benefits beginning in January.
  • Tammy Flanagan, writing in Govexec, provides “a checklist to help [federal and postal employees and retirees] prioritize as [they] sort through your federal retirement and insurance benefits.”
  • Modern Healthcare reports,
    • “Healthcare companies pursuing mergers and acquisitions will be required to submit additional information about their proposals under a final rule approved by the Federal Trade Commission Thursday.
    • “The final rule amends the Hart-Scott-Rodino Act form, which had not been updated for 46 years. When the rule goes into effect, likely early next year, healthcare companies involved in M&A proposals must list acquisitions that occurred within the last five years, disclose private equity and minority stakeholders with decision-making authority and report supplier relationships shared by the merging parties to the FTC, among other requirements.”
  • Bloomberg informs us,
    • Johnson & Johnson did not wrongly manipulate bankruptcy rules when it filed an insolvency case in Texas and not its home state of New Jersey, a federal judge ruled, increasing the odds the consumer health giant can settle claims its baby powder gave women cancer.
    • Judge Christopher Lopez said Thursday he’ll keep a J&J subsidiary in his Houston courtroom, dismissing claims the company improperly skirted a federal appeals court for New Jersey that has twice stopped its bid to end thousands of talc injury lawsuits. 
    • “I want to assure everyone that they are going to get a fair trial in front of me,” Lopez said.
    • J&J is offering more than $8 billion to settle the litigation, a proposal the company has said is supported by roughly 83% of the women who voted on it. The settlement is being offered through a corporate shell J&J created to absorb the cancer claims and file bankruptcy, a controversial legal tactic known as the Texas Two Step.
  • The American Hospital Association News points out,
    • “The Health Resources and Services Administration Oct. 9 announced it will award nearly $19 million to 15 states for identifying and implementing maternal health strategies. The funds are part of HRSA’s Enhancing Maternal Health Initiative and will support State Maternal Health Innovation programs to help identify key drivers of maternal mortality in each state, develop strategies and implement new interventions to address those issues. The state programs have implemented a range of interventions to address maternal health challenges, which include early identification and treatment of hypertension to reduce preeclampsia and other risks, providing mobile simulation trainings to prepare health care providers for a range of adverse labor events, expanding access to trainings to rural and frontier hospitals that do not have a dedicated obstetrics department, and creating resources to improve first responders’ ability to respond to patients with substance use disorder during and after pregnancy.”

From the public health and medical research front,

  • The International Foundation of Employee Benefit Plans lets us know,
    • “Today is World Mental Health Day, a time to recognize the importance of mental health and to reaffirm commitments to improving mental health through education, awareness and advocacy. Many plan sponsors look toward mental health trends to stay informed on strategies for their workforce. Read on for key takeaways from a recent International Foundation webcast on 2024 mental health trends.
    • “The after-effects of the COVID-19 pandemic have resulted in increases in mental health needs across North America. In a 2024 survey from Gallup, U.S. adults reported how they thought mental health issues are handled compared to physical health issues: 38% reported “much worse,” 37% reported “somewhat worse,” and 15% reported “about the same.” The same survey indicates a perception that mental health conditions, including depression and anxiety, have increased over the past five years.
    • “According to a report from SunLife Canada, employers are seeing a rise in mental health care costs, including short- and long-term disability claims. The increased costs are sparking conversations about mental health treatment and leading employers to improve their employee benefits offerings to address mental health care.”
  • Per a U.S. Department of Agriculture press release,
    • BrucePac, a Durant, Okla. establishment, is recalling approximately 9,986,245 pounds of ready-to-eat (RTE) meat and poultry products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    • The ready-to-eat meat and poultry items were produced from June 19, 2024, to October 8, 2024. These products were shipped to other establishments and distributors nationwide then distributed to restaurants and institutions. Information regarding product labels and the list of products will be provided when available.
    • The products subject to recall bear establishment numbers “51205 or P-51205” inside or under the USDA mark of inspection.
  • The American Hospital Association News notes,
    • “The National Institutes of Health Oct. 10 released results of a study that found that infection from COVID-19 in the first wave of the pandemic appeared to significantly increase the risk of heart attack, stroke and death for up to three years for unvaccinated individuals. When infected, those individuals had double the risk for cardiovascular events, and people with severe cases had nearly four times the risk. The study also is the first to show that increased risk of heart attack and stroke in people with severe COVID-19 may have a genetic component involving blood type. It is unclear if the risk of cardiovascular disease is or may be persistent for people who have had severe COVID-19 from 2021 to the present, NIH said.”
  • The Wall Street Journal reports,
    • “Researchers are making progress toward vaccines that train healthy people’s immune systems to eliminate signs of cancer before it develops. 
    • “Vaccines are in early trials for people with inherited genetic mutations that put them at a greater risk. Other shots are designed to destroy precancerous lesions to stop full-blown disease. 
    • “It’s the future of cancer prevention,” says Dr. Ajay Bansal, a gastroenterologist at the University of Kansas Cancer Center.” * * *
    • “Many consider cancer vaccines to be a form of immunotherapy, a kind of treatment that has revolutionized cancer care by using the immune system to beat back cancer cells. Some of those therapies release the brakes on the immune system. Cancer vaccines, by contrast, are meant to boost the immune response and direct it where to go.
    • “Cancer cells and even pre-cancer cells know how to hide from the immune system,” says Dr. Neeha Zaidi, a medical oncologist at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. “It needs that help from a vaccine.”
  • The National Institutes of Health’s Director, writing her in blog, tells us,
    • “Developing a new drug from scratch can take a decade or more. But sometimes promising treatment options come from repurposing existing drugs for completely different medical conditions. I’m happy to share a new example of this: a cancer drug called pomalidomide that was found in a clinical trial to be safe and effective for treating a blood disorder called hereditary hemorrhagic telangiectasia (HHT).
    • “HHT is an inherited blood vessel disorder that can cause excessive or even life-threatening bleeding. The disease is rare, affecting about 1 in every 5,000 people worldwide, but because HHT is poorly understood and often misdiagnosed, its true incidence is likely greater. Most people with HHT experience recurrent severe nosebleeds, often in combination with mental health disorders such as depression and post-traumatic stress disorder, as well as other health conditions. HHT can also worsen with age and impact quality of life.
    • “However, recent findings from an NIH-supported clinical trial, reported in the New England Journal of Medicine, show that daily treatment with pomalidomide in people with HHT led to a significant reduction in nosebleed severity. Compared to trial participants taking a placebo, those taking pomalidomide needed fewer blood or iron transfusions and reported improvements in their quality of life. Because of these results, the trial was stopped months ahead of schedule, having found sufficient evidence that the treatment was safe and effective.”
  • Per MedPage Today,
    • “Medicare annual wellness visits were associated with a 21% increase in mild cognitive impairment diagnoses.
    • “Those with a wellness evaluation received a diagnosis 76 days earlier than others.
    • “Findings suggest the Medicare wellness visit policy may help identify cognitive impairment earlier.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “CVS Health is moving ahead with expansion plans for Oak Street Health, even as the company reportedly considers a restructuring in the coming months.
    • “CVS is conducting a strategic review, according to media reports citing people familiar with the matter and is weighing options for separating some of the company’s businesses, which include its retail pharmacy, insurance arm Aetna, pharmacy benefit manager CVS Caremark and primary care provider Oak Street.
    • “A spokesperson said CVS is sticking with its previously announced expansion plan for Oak Street but did not respond to questions about how many clinics it has opened this year. As of August, Oak Street had opened 16 clinics in 10 states since December, with aggressive plans to open another 38 or so clinics by the end of the year.”
  • Per Fierce Healthcare,
    • “Henry Ford Health has launched a population health subsidiary to help manage high-risk patients’ conditions and reduce costs tied to preventable hospitalizations or readmissions.
      Troy, Michigan-based Populance is described by the nonprofit health system as an extension of the “dozens” of case management programs it and its insurance subsidiary, Health Alliance Plan, have designed over the past two decades.
    • “Those programs—often designed with value-based care strategies in mind—will be supported at Populance with health analytics capabilities to help spot and address high-risk patients, the system said.
    • “Because we know this approach to population health management works—for our patients, our members and our physicians—we want to make these services available to other physicians, health systems and health plans to create healthier, more equitable outcomes in all the communities we serve,” Robin Damschroder, president of value-based enterprise and chief financial officer at Henry Ford Health, said in a release.”
  • RAND issued a paper titled “The Expense of Heath Care Explained: What Americans Need to Know.”
    • “Health care costs remain a critical concern for policymakers, providers, and patients alike. As voters head to the polls, the effectiveness of recent policies like the No Surprises Act and Medicare drug price negotiations are just beginning to be felt. Meanwhile, other major concerns loom, including how to deal with massive consolidation across the health care industry, and the complex dynamics of drug pricing, as well as burnout and other forces leading to shortages of health care providers.
    • “We asked three experts on the economics of health care to explain some of the financial and public policy forces at work. Cheryl Damberg holds the distinguished chair in Health Care Payment Policy and is director of the RAND Center of Excellence on Health System Performance. Andrew Mulcahy is a senior health economist at RAND who focuses on payments for health care services and prescription drugs. Erin Taylor is a senior policy researcher at RAND who is currently co-project director of the evaluation of the Medicare Part D Senior Savings Model.”
  • Per BioPharma Dive,
    • Within the pharmaceutical industry, a multibillion-dollar race is underway to top Novo Nordisk’s and Eli Lilly’s in-demand obesity drugs.
    • Dozens of companies, large and small, have set out to test experimental medicines they claim could be more potent, convenient or have fewer side effects than Novo’s Wegovy and Lilly’s Zepbound. But those two companies are already hard at work with successors of their own.
    • The next six months figure to be an important preview. Data are expected for a number of drugs that are already, or are shaping up to be, contenders in this high-stakes competition. The readouts will be closely watched, as they will set expectations for how the obesity drug market — currently a duopoly between Lilly and Novo — will look in the future.
  • The article tells you what to expect.
  • The Washington Post reports,
    • “Amazon plans to expand its drug delivery business as the company seeks more ways to insinuate itself into the daily lives of everyday Americans. The move would see the largest online retailer in the United States compete more directly with pharmacy retailers like CVS and Walgreens.
    • “Next year, Amazon customers in 20 cities — including Dallas, Minneapolis and Philadelphia — will be able to get Amazon Pharmacy medications delivered by the company, Amazon Pharmacy VP Hannah McClellan Richards said Wednesday. And a growing number of those deliveries will be completed within less than 24 hours, the company said.
    • “Richards said Amazon will double the number of cities with same-day delivery of medications next year, in part by building pharmacies in existing same-day delivery facilities that are “integrated directly into Amazon’s core logistics network.”

Midweek Update

David Ermer–ACA, CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, OPM, U.S. Healthcare–

From Washington, DC,

  • The New York Times reports,
    • “Healthcare facilities across the west coast of Florida, from clinics to nursing homes, are temporarily shutting their doors and evacuating patients in preparation for Hurricane Milton’s potentially devastating landfall.
    • “Mandatory evacuation orders in Pinellas County, which includes Clearwater and St. Petersburg, affect about 6,600 patients at six hospitals, 25 nursing homes and 44 assisted living facilities, according to the order. Scores of medical clinics and dialysis centers across the region have also closed, including dozens of outpatient facilities operated by the BayCare, a health care network.
    • “The region’s only Level 1 trauma center, Tampa General Hospital, has deployed a temporary flood barricade that officials hope will stave off the storm surge. Most of the hospitals in the region that are still open have suspended elective operations or have stopped accepting new patients.
    • “University of Florida Health, which operates about a dozen hospitals across the state, had enough food, water and fuel to keep its facilities operating for 96 hours, according to Peyton Wesner, a spokesman.”
  • and
    • “U.S. officials approved airlifts of IV fluids from overseas manufacturing plants on Wednesday to ease shortages caused by Hurricane Helene that have forced hospitals to begin postponing surgeries as a way to ration supplies for the most fragile patients.
    • “The current shortage occurred when flooding coursed through western North Carolina and damaged a Baxter plant, which is now closed for cleaning. The plant makes about 60 percent of the United States’ supply of fluids used in IVs, for in-home dialysis and for people who rely on IV nutrition. They include premature babies in intensive care and patients who rely on tube feeding to survive.
    • “The situation could become even more dire now that Hurricane Milton is hitting Florida. On Tuesday, workers at B. Braun, makers of a fourth of the nation’s IV fluids, loaded trucks at the company’s plant in Daytona Beach with the medical bags and drove them north through the night to what they hoped would be a safer location.
    • “The Baxter plant, in Marion, N.C., and the B. Braun site in Daytona Beach manufacture about 85 percent of the nation’s supply of IV fluids. Experts on shortages have long pointed out the risk of such over-concentration of critical supplies, citing exposure to disasters like those now at hand. Even before the latest storm, supplies were tight and reflected a longstanding problem of how few companies are willing to produce crucial but low-cost and low-profit medical products.”
  • Here’s a link to an HHS Secretary letter to healthcare leaders about the IV fluid shortage, and Beckers Payer Issues offers five notes on insurer response to Hurricane Milton.
  • Kevin Moss, writing in Govexec, takes a closer look at 2025 FEHB premiums.
  • CMS has issued a memorandum with payment parameters guidance for the 2026 plan year
    • The 2025 maximum limit on cost sharing for FEHB and other group plans is $10.150 for self only coverage and $20,300 for other than self only coverage. These limits represent approximately a 10.3% increase over the 2025 maximum limits of $9,200 for self only coverage and $18,400 for other than self only coverage.
  • “The International Foundation of Employee Benefit Plans shares links to the final 1094-B, 1095-B, 1094-C, and 1095-C forms [and instructions] that employers, plan sponsors and group health insurers will use to report 2024 health coverage to plan members, and the IRS as required by the Affordable Care Act (ACA).” 
  • STAT News tells us,
    • “A new report from congressional budget experts this week estimated that it would cost Medicare an additional $35 billion over nine years if the program began covering GLP-1 drugs for obesity. But the report also noted that half of seniors who would qualify for obesity coverage already have access to the drugs for other conditions.”
  • The American Hospital Association News notes,
    • “The Centers for Medicare & Medicaid Services Oct. 9 released a request for information and a sample list of prescription drugs it intends to include under a proposed Medicare $2 Drug List Model. Under the model, people enrolled in a Part D plan would have access to these drugs for a low, fixed copayment no higher than $2 for a month’s supply per drug. The model would provide individuals more certainty about out-of-pocket costs for these generic covered drugs that would target common conditions such as high cholesterol and high blood pressure. The Center for Medicare and Medicaid Innovation’s model aims to test whether a simplified approach to offering low-cost, clinically important generic drugs can improve medication adherence, lead to better health outcomes and improve satisfaction with the Part D prescription drug benefit among Medicare beneficiaries and prescribers. It is also aligned with Executive Order 14087, “Lowering Prescription Drug Costs for Americans,” which directed the creation of new payment models to lower drug costs and promote access. Comments are due Dec. 9 through a CMS survey.”
  • KFF provides us with “A Current [Detailed] Snapshot of the Medicare Part D Prescription Drug Benefit.”
  • The Wall Street Journal reports,
    • “CVS Health filed a motion seeking to disqualify top Federal Trade Commission officials from participating in a case regarding some of its businesses over alleged bias against pharmacy benefit managers.
    • “The healthcare company said Chair Lina Khan, Commissioner Rebecca Kelly Slaughter and Commissioner Alvaro Bedoya through public statements show they have prejudged the matter at hand and that their participation would violate the due process rights of respondents Caremark Rx and Zinc Health Services.
    • “CVS specified that past statements made false assertions that are critical to the merits of the case, including that pharmacy benefit managers “control” drug pricing and patient access to drugs including insulin.
    • “Cigna Group, on behalf of Express Scripts and other of its businesses, also filed a motion seeking to disqualify Khan, Slaughter and Bedoya.
    • “UnitedHealth Group, who reportedly filed a similar motion, didn’t immediately respond to a request for comment.”

From the public health and medical research front,

  • STAT News points out,
    • “A trio of scientists who opened new doors in our understanding of the structure of proteins — the fundamental building blocks of biology — and even came up with ways to create new proteins won the Nobel Prize in chemistry Wednesday.
    • “The prize went to David Baker of the University of Washington, and to Demis Hassabis and John Jumper, who work at Google DeepMind in London. Baker will receive half the 11 million Swedish kronor (just over $1 million) prize, while Hassabis and Jumper will split the other half.” * * *
    • “Baker said he was sleeping when he received the Nobel call early Wednesday morning, as is often the case for laureates in the U.S. When he was told he had won the prize, his wife started yelling, drowning out the person on the phone. He had to go to another room so he could hear the rest of the call, he said. 
    • “Asked by one journalist to pick his favorite protein, Baker demurred, saying he didn’t want to identify just one. But he did highlight one that he and his colleagues had crafted that could potentially block the coronavirus behind Covid-19 from infecting cells, hinting at one of the applications of his discoveries that researchers are now pursuing. 
    • “I’ve been very excited about the idea of a nasal spray of little designed proteins that would protect against all possible pandemic viruses,” he said.”
  • Kudos to the recipients.
  • The American Medical Association tells us what doctors wish their patients knew about microplastics.
  • The National Cancer Institute shares its Cancer Information Highlights about “Breast Cancer | Jaw Necrosis | Leiomyosarcoma.”
  • Per National Institutes of Health press release,
    • “The National Institutes of Health has launched a nationwide consortium to address the dramatic rise in youth diagnosed with type 2 diabetes over the past two decades, a trend that is expected to continue. The effort aims to advance understanding of the biologic, social, and environmental drivers of youth-onset type 2 diabetes, with the goals of determining which children are at highest risk for developing the disease and how to better prevent, screen for, and manage type 2 diabetes in young people.
    • “Our children who are overweight or have obesity are at risk, but we don’t know how best to identify the children who will progress to type 2 diabetes,” said Rose Gubitosi-Klug, M.D., Ph.D., study lead, and chief of pediatric endocrinology at Case Western Reserve University/Rainbow Babies and Children’s Hospital, Cleveland. “This study will bring us closer to our goal of prevention of type 2 diabetes in future generations of youth.” * * *
    • “For more information about the study, known as DISCOVERY of Risk Factors for Type 2 Diabetes in Youth, please visit discovery.bsc.gwu.edu.”

From the U.S. healthcare business front,

  • The American Hospital Association News lets us know,
    • “The average annual premium for employer-sponsored family health coverage rose 7% in 2024 to $25,572, according to the latest KFF annual survey. It is the second consecutive year with a 7% increase. For workers who have an annual deductible for single coverage, the 2024 average is $1,787, similar to last year’s $1,735 and up 8% from 2019. The survey found that the amount workers’ pay toward annual premiums has increased less than 5% since 2019, which may be due to a tight labor market.”
  • Per Beckers Hospital CFO Report,
    • “Chicago-based CommonSpirit is “investing significantly in high-growth markets,” such as Arizona and Colorado, to ensure the long-term sustainability of the health system, CFO Dan Morissette said during the company’s investor call on Oct. 4.
    • “Last year, Centennial, Colo.-based Centura Health folded into CommonSpirit, which manages 20 hospitals and more than 240 care sites in Colorado, Kansas and Utah that were previously managed by Centura. 
    • “The news came shortly after CommonSpirit and Altamonte Springs, Fla.-based AdventHealth said they would end their Centura Health joint venture after 27 years, with each system directly managing their respective care sites in Kansas and Colorado. 
    • “Much of our focus in this market is on transition alignment and ambulatory care sites, as well as future inpatient growth to meet the rapidly expanding demand,” Mr. Morissette said. “We also announced a partnership with Kaiser in this market, which is an important new collaboration for us.Intentional capital deployment means taking a system-level approach to reviewing and 
    • “CommonSpirit is also diversifying its service line in these high-growth markets. Areas of focus include behavioral health, cancer care and outpatient care.”
  • Per Fierce Pharma,
    • “GSK has agreed to pay up to $2.2 billion to resolve approximately 80,000 lawsuits brought by users of Zantac who claimed the heartburn drug caused their cancer.
    • “The agreement frees the British pharma giant from litigating 93% of the state court cases it faced in the U.S., most of which had been consolidated in Delaware. The settlement was reached with 10 plaintiff firms with the agreement that GSK does not admit liability, the company said.
    • “With the deal, lawyers representing the plaintiffs are unanimously recommending that clients accept terms of the settlement, which is expected to be complete by the end of the first half of 2025, GSK said.
    • “The agreement is in line with a similar settlement Sanofi reportedly made earlier this year. The French pharma consented to pay $100 million to resolve roughly 4,000 Zantac claims, Bloomberg reported in April. That deal paid plaintiffs roughly $25,000 each. The GSK settlement comes to approximately $27,500 per claimant.
    • ‘In May of this year, Pfizer also settled approximately 10,000 Zantac lawsuits for an undisclosed figure. Pfizer had the rights to sell the antacid from 1998 to 2006.
    • “In addition to the $2.2 billion deal, GSK also said on Wednesday that it will pay $70 million to resolve a qui tam complaint filed by Connecticut-based laboratory Valisure, which first raised alarm bells about Zantac’s risks in 2019 during routine batch testing.”
  • Per MedTech Dive,
    • “The number of medical devices with artificial intelligence technology has risen sharply in the past decade. 
    • “The Food and Drug Administration has authorized 950 AI or machine learning-enabled devices as of Aug. 7, 2024, according to the agency’s database. While the FDA authorized the first AI-enabled device in 1995, the number of submissions has spiked in recent years.
    • “In 2015, the FDA authorized six AI medical devices. In 2023, the agency authorized 221 devices, according to data reviewed by MedTech Dive.
    • “The trend has been driven by more connected devices, more investment into AI and machine learning and growing familiarity with how software is regulated as a medical device, experts said in interviews.
    • “We’re definitely seeing huge increases in investment. There’s no doubt about that,” said Jennifer Goldsack, CEO of the Digital Medicine Society, an industry group for digital health.”