Monday Report

HSA

Monday Report

David Ermer–ACA, CDC, CMS, Congress, FDA, HSA, Medical / Rx research, Obesity, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Hill reports,
    • “Top Republicans are signaling progress in government funding talks as leaders look to clinch a deal ahead of a looming Friday deadline. 
    • “House Appropriations Chair Tom Cole (R-Okla.) told reporters Monday that the “differences are narrowing” between all sides as they try to hash out the last significant funding deal in the divided Congress.
    • “It’s both between the House and the Senate and Republicans and Democrats. So, they’re both institutional differences, and there are partisan differences,” Cole said. But he added “there are a lot fewer of them than there were 24 hours ago.” * * *
    • “Pressed about the status of health care as leaders look to tie up loose ends in the CR, House Majority Leader Steve Scalise (R-La.) said Monday there are “big discussions on all of the remaining items.”
    • “But we’re trying to get it wrapped up,” he said. 
    • “According to a source familiar, a package of key health policies is expected to be attached to the stopgap funding bill. It will likely include a two-year extension of telehealth flexibilities for Medicare, as well as an overhaul of pharmacy benefit managers’ business practices.” 
  • Fierce Healthcare adds,
    • “Pharmacy benefit manager reform is included in a larger-than-anticipated healthcare package, but the PBM lobby is fighting the legislation at the eleventh hour.
    • “Lawmakers appear to have agreed to a lame-duck healthcare package which, in addition to PBM reform, will include key program extensions.
    • “As of last weekend, the package included an increase to the Medicare physician fee schedule of 2.5% for one year, bonuses to alternative payment models and a reauthorization of the SUPPORT Act for dealing with the opioid crisis.
    • “PBM policies will be used as budgetary offsets. The legislation would ban spread pricing in Medicaid, ensure Part D plan sponsors delink PBM fees from the price of a drug and includes other transparency requirements.
    • “The end-of-year health care package accompanying the Continuing Resolution has morphed into a massive 400-page bill that includes provisions that would undermine the role that PBMs play in lowering costs and providing choices for employers in the prescription drug marketplace,” said the PBM trade lobby, the Pharmaceutical Care Management Association (PCMA), in a statement Dec. 16. “The health care provisions included in the latest draft, as reported in the media, risk increasing costs for health plan sponsors, like employers and labor unions, patients, and families, and hiking up premiums for seniors.”
  • One Digital informs us that “Congress passed the Paperwork Reduction Act and the Employer Reporting Improvement Act, each of which modify the ACA’s provisions on 1094 and 1095 tax form reporting. President Biden is expected to sign both acts into law, significantly altering ACA reporting requirements.”
    • “The Paperwork Reduction Act amends the ACA by no longer requiring employers and health insurance providers to send tax forms to the covered individuals under their health plan. Previously employers and/or insurance providers had to send 1095-B/1095-C tax form to each covered individual showing proof of minimum essential coverage. Now, those forms must only be sent when requested by the covered individual. If a covered individual requests a form, the form must be provided by January 31 or 30 days after the date of the request, whichever is later. Employers and insurance providers must inform covered individuals of their right to request a form.”
    • “The Employer Reporting Improvement Act codifies IRS regulations that allow for an individual’s date of birth to be substituted if the individual’s Tax Identification Number is not available. The Act also amends the ACA to incorporate IRS regulations allowing employers and insurance providers to offer 1095-B and 1095-C tax forms to individuals electronically.
    • Additionally, and more importantly to employers, the Act requires the IRS to give large employers at least 90 days to respond to 226-J letters that issue a proposed employer shared responsibility payment. Previously, employers had only 30 days to respond. Finally, the Act establishes a six-year statute of limitations for collecting these payments.”
       
  • The Plan Sponsor Council of America tells us,
    • “The ERISA Advisory Council (EAC) voted on and approved 12 recommendations for the Department of Labor (DOL) to improve health insurance claim denials and related appeals. These reforms range from better oversight of AI determinations to requiring payouts for prior approvals.
    • “Lisa Gomez, head of the Employee Benefit Security Administration (EBSA), described these proposed reforms today as “strangely and somewhat tragically timely, with the events of last week,” in reference to the killing of UnitedHealthcare CEO Brian Thompson in Manhattan on Dec. 4.”
    • Due to the Affordable Care Act, ERISA appeal procedure changes embedded in regulations typically apply to FEHB carriers.
  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services Dec. 16 published a final rule implementing certain provisions related to information blocking exceptions. The rule revises defined terms related to protecting access to care for purposes of the information blocking regulations.
    • “The agency adopted select provisions first proposed in August as part of the much larger Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) rule. The adopted provisions are designed to address concerns from patients, health care providers and other stakeholders regarding patient privacy, access to care, preferences for electronic health information sharing, and methods for achieving a balance between certainty and flexibility for entities involved in enhancing EHI interoperability and exchange.
    • “The finalized “Protecting Care Access Exception” would allow entities to restrict EHI sharing under certain conditions to mitigate the risk of legal repercussions for patients, providers or care facilitators involved in lawful reproductive health services. The provisions will be effective immediately when published Dec. 17 in the Federal Register.
    • “This is the second rule in less than a week containing policies originally included in the proposed HTI-2 rule. As such, additional provisions of the HTI-2 rule, including prior authorization application programming interfaces, United States Core Data for Interoperability Version 4 standards and public health interoperability requirements — which are currently under review by the White House Office of Management and Budget — could be published soon.”
  • and
    • “The Centers for Medicare & Medicaid Services Dec. 15 announced an extension to Dec. 18 for enrollment in federally facilitated marketplace coverage that begins Jan. 1. This applies to the 31 states that use HealthCare.gov for signups. Those consumers previously had until Dec. 15 to enroll for a full year of coverage. Individuals who enroll for 2025 coverage after Dec. 18 will have their plans begin Feb. 1. Individuals in Washington, D.C., and the 19 states that operate their own state-based marketplaces are advised to visit their state website for deadlines and effective dates for their coverage.”
  • and
    • “The Health Resources and Services Administration last week directed Sanofi to cease implementation of its 340B rebate proposal immediately and to inform HRSA of its plans no later than Dec. 20 in order to provide adequate notice to covered entities.
    • “By way of this correspondence, HRSA provides warning that this unapproved credit proposal violates Sanofi’s obligations under the 340B statute, and HRSA expects Sanofi to cease implementation of it,” wrote HRSA Administrator Carole Johnson.
    • “The letter says that the proposal, if implemented, would violate Sanofi’s obligations under the 340B statute and subject Sanofi to potential consequences, such as termination of Sanofi’s Pharmaceutical Pricing Agreement and civil monetary penalties.
    • “In its Nov. 22 letter to 340B covered entities, Sanofi said it would be effectuating 340B discounts via the new credit model as of Jan. 6, 2025, for disproportionate share hospitals, critical access hospitals, rural referral centers and sole community hospitals.”
  • Govexec points out,
    • “The Office of Personnel Management is set to publish a final rule Tuesday that would finally implement provisions of a seven-year-old law aimed at reducing agencies’ ability to put federal workers accused of misconduct on prolonged stints of administrative leave.
    • “In 2016, Congress enacted the Administrative Leave Act as part of the 2017 National Defense Authorization Act. The law tries to reduce agencies’ reliance on placing federal workers who are under investigation into employment limbo—paid but unable to work—for long stretches of time. It also updated the government’s policies on weather and safety leave.
    • “Though OPM proposed regulations to implement all of the law’s provisions in 2017, only the provisions governing weather and safety leave actually made it across the finish line. But earlier this year, the environmental advocacy group Public Employees for Environmental Responsibility sued the HR agency seeking to force it to act.
    • “In a final rule set for publication Tuesday in the Federal Register, OPM formally implemented the 2016 law’s restrictions on administrative leave. While the new rule will be effective Jan. 17, 2025, agencies have until October to comply with the new restrictions on administrative leave.”

In Food and Drug Administration news,

  • MedTech Dive relates
    • Zimmer Biomet received Food and Drug Administration clearance for a new stemless shoulder implant, called Osseofit.
    • The implant is shaped to match the anatomy of patients’ humerus, or upper shoulder bone, while preserving as much of their healthy bone as possible in total shoulder replacement procedures. Zimmer announced the clearance on Friday.
    • CEO Ivan Tornos highlighted stemless shoulder implants as a meaningful growth driver for the orthopedics company in an Oct. 30 investor call.
  • Per Fierce Pharma
    • “The FDA has blessed two previously approved medicines—one a cream and the other an injection—to treat atopic dermatitis (AD). Both products now will be available to a significantly larger patient population as roughly 26 million in the U.S. have the disorder, which is also known as eczema.
    • “Organon’s Vtama, a topical cream originally approved for plaque psoriasis in 2022, is now cleared to treat AD, the company said early Monday. The nod came three months after New Jersey-based Organon acquired the product in a $1.2 billion takeover of Dermavant. 
    • “Similarly, the FDA gave a thumbs-up to Galderma’s Nemluvio to treat AD. The drug, a monthly subcutaneous injection, was previously endorsed by the U.S. regulator for prurigo nodularis.” 
  • and
    • “After seven decades with no advances in the treatment of the genetic disorder classic congenital adrenal hyperplasia (CAH), Neurocrine Biosciences has scored FDA approval for its first-in-class, twice-daily oral medicine Crenessity (crinecerfont).
    • “The blessing came nearly two weeks before its FDA target date and is termed as “paradigm shifting” by the San Diego-based company. The selective oral corticotropin-releasing factor type 1 receptor (CRF) antagonist can be used by CAH patients ages 4 and older.
    • “Serving as an add-on to glucocorticoid replacement therapies, Crenessity reduces excess adrenocorticotropic hormone (ACTH) and downstream adrenal androgen production, allowing for glucocorticoid dose reduction.”
  • Cardiovascular Business alerts us,
    • “The U.S. Food and Drug Administration (FDA) and Boston Scientific today sent an urgent alert to patients and healthcare providers about the potential need for early device replacement of some Accolade pacemakers.
    • The company announced a recall for a subset of its Accolade devices because of an increased risk of permanently entering the safety mode. This has limited functionality, making the device unable to properly regulate the heart’s rhythm and rate. Most of the activations have occurred during follow-up office or hospital visits when the devices are interrogated for data.
    • There have been two reported patient deaths in pacemaker dependent patients after the devices went into safety mode in an ambulatory outpatient medical setting. Boston Scientific said about 70% of safety mode events occurred during in-office interrogations from a Latitude programmer, and the remaining incidents took place in an ambulatory setting.
    • “The risk of harm may be greater when safety mode occurs in an ambulatory setting, as patients are not in a monitored clinical environment,” the company said in its recall notice.
  • Beckers Hospital Review adds,
    • “The FDA has recalled more than 233,000 bottles of antidepressant duloxetine, sold by Rising Pharmaceuticals, due to a potential cancer risk. 
    • “The recall, issued Dec. 5, was prompted by the discovery of a nitrosamine impurity, N-nitroso-duloxetine in the capsules which exceeds the FDA’s safety threshold. 
    • ‘The FDA has classified the recall as a Class II risk, its second most severe classification. The recall affects 233,000 bottles of duloxetine, which is used to treat conditions such as depression and generalized anxiety disorder. 
    • “The FDA also recalled 7,107 bottles of duloxetine capsules distributed by Towa Pharmaceutical Europe in October for similar concerns about nitrosamine impurities.” 

From the public health and medical research front,

  • MedPage Today reports,
    • “CDC could not confirm what was suspected to have been the first H5N1 bird flu case linked to raw milk.
    • “The patient, a child in Marin County, California, experienced fever and vomiting after drinking raw milk, as reported last week. The child initially tested positive for influenza A, with the local lab unable to find evidence of person-to person transmission between the child and her family members.
    • “The State Laboratory and the CDC conducted additional testing, “but due to low levels of viral RNA, they were unable to confirm whether the influenza A virus present was H5N1 (avian influenza) or seasonal influenza,” according to the Marin County public health department.”
  • The Washington Post tells us,
    • “Nearly a quarter of U.S. adults reported living with chronic pain in 2023, according to a recent report from the Centers for Disease Control and Prevention.
    • “Just over 24 percent (24.3 percent) of survey respondents said they experienced chronic pain either most days or every day, the CDC said, and nearly 9 percent of adults had “high-impact chronic pain” in the previous three months, meaning their pain frequently limited their life or work activities.” * * *
    • “Chronic pain and pain that often restricts life or work activities, referred to in this report as high-impact chronic pain are the most common reasons adults seek medical care, and are associated with decreased quality of life, opioid misuse, increased anxiety and depression, and unmet mental health needs,” co-authors Jacqueline W. Lucas and Inderbir Sohi wrote in a data brief on the numbers.”
  • Beckers Hospital Review adds,
    • “In 2023, the United States saw a slight decrease in obesity prevalence among adults, according to research findings published Dec. 13 in JAMA. 
    • “Amid projections of increasing obesity rates over the next decade, researchers from Boston Children’s Hospital and Optum Life Sciences analyzed body mass index data from 2013 to 2023. The dataset included nearly 48 million BMI measurements from 16.7 million nonpregnant adults. 
    • “Between 2013 and 2022, mean population BMI and obesity rates rose annually. Both figures slightly declined in 2023, the study found. 
    • “The researchers suggested this change could be due to weight loss GLP-1s such as semaglutide (Wegovy) and “pandemic-associated demographic and behavior changes.”
  • A recent National Health Statistics Reports shares characteristics of older Americans who fulfilled physical activity guidelines in 2022.
  • The American Medical Association lets us know what doctors wish their patients knew about hand, foot, and mouth disease.
  • MedPage Today notes,
    • “Diets higher in inflammatory foods were tied to an increased incidence of dementia in older adults, longitudinal data from the Framingham Heart Study Offspring cohort showed.
    • “Over 13 years of follow-up, higher Dietary Inflammatory Index (DII) scores averaged across three time points were linearly associated with an increased incidence of all-cause dementia (HR 1.21, 95% CI 1.10-1.33, P<0.001), reported Debora Melo van Lent, PhD, of UT Health San Antonio in Texas, and co-authors.
    • “Similarly, higher DII scores were linearly associated with an increase in Alzheimer’s disease dementia (HR 1.20, 95% CI 1.07-1.34, P=0.002), the researchers reported in Alzheimer’s & Dementia. Findings were adjusted for demographic, lifestyle, and clinical covariates.
    • “Although these promising findings need to be replicated and further validated, our results suggest that diets that correlate with low DII scores may prevent late-life dementia,” van Lent and colleagues noted.”
  • To that end, Consumer Reports, writing in the Washington Post, discusses “four ways to reduce inflammation for better health. It’s thought to be an underlying cause of diabetes, heart disease and more. Diet and lifestyle can help you control it.”
  • Per a press release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness of tabelecleucel (“tab-cel”®, Pierre Fabre) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).
    • “ICER’s report on this therapy was the subject of the November 2024 public meeting of the New England CEPAC, one of ICER’s three independent evidence appraisal committees. 
    • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations 
  • STAT News reports,
    • “Just over a year ago the PREVENT calculator to predict cardiovascular risk was released by the American Heart Association. It was acclaimed for improving on a 2013 model that didn’t take into account companion conditions such as kidney disease or type 2 diabetes, or include people from more diverse backgrounds.
    • “PREVENT soon drew attention for its potential to reduce the number of Americans eligible to receive widely prescribed cholesterol-lowering statins, projected in two analyses published in June and July. 
    • “A less noted change was the addition of heart failure to conditions estimated by the risk calculator, alongside the traditional targets of heart attack and stroke. Heart failure is a serious illness that means the heart can no longer pump blood through the body as well as it should. It’s different from diseases that narrow blood vessels that feed the heart or brain.
    • “Heart failure has no cure, making it more urgent to identify who’s at risk. PREVENT allows that risk to be estimated using information typically collected in a regular primary care visit.”

From the U.S. healthcare business front,

  • Reuters reports,
    • “Powerful weight-loss drugs are expanding use of U.S. health care as patients starting prescriptions are diagnosed with obesity-related conditions or take the drugs to become eligible for other services, health records and discussions with doctors show.
    • “An exclusive analysis of hundreds of thousands of electronic patient records by health data firm Truveta found slight, but measurable, increases in first-time diagnoses of sleep apnea, cardiovascular disease, and type 2 diabetes within 15 days of an initial prescription for a GLP-1 weight-loss drug between 2020 and 2024.
    • “In addition to obesity-related conditions, some patients are being prescribed the drugs to lose weight and become eligible for services, including organ transplants, fertility treatments or knee replacements, according to interviews with seven doctors and five other health experts.
    • “This is a population that previously felt stigmatized by health care providers and often didn’t return. But now that they’re actually seeing themselves get healthier, asking clinicians questions and engaging more, I do think we’re seeing new patients,” said Dr. Rekha Kumar, a New York endocrinologist and obesity medicine specialist.”
  • McKinsey and Company explore how the healthcare industry can weather current challenges.
    • “The healthcare industry has been buffeted by a growing number of challenges over the past few years. This turbulence struck provider organizations in 2022, while payers were initially sheltered from the storm (Exhibit 1). But conditions became more difficult for payers in 2023, which has continued into this year, and there’s limited respite on the horizon. Unlike the widespread challenges the provider and payer sectors have faced, the picture for pharmacy services has been more nuanced. Some organizations have been propelled by tailwinds from pharmaceutical innovation and new delivery models, while others have battled headwinds from increased regulatory scrutiny. The healthcare services and technology (HST) sector, in contrast, has benefited from continued demand for data, analytics, and software. Along with pressures on earnings, the healthcare sector has also faced challenges in the capital markets, with deal activity in 2024 lower than 2023, according to McKinsey analysis.”
  • Per the American Hospital Association News,
  • Healthcare IT News tells us “74% of hospital leaders say virtual nursing will become integral to acute care. A nurse expert [in the article] discusses the results of a new survey from AvaSure showing that, while virtual nursing has yet to gain traction in acute inpatient care, it holds much promise – and already is showing results that benefit both nurses and the bottom line.”
  • A recent National Health Statistics Report examines under age 65 enrollment in high deductible and consumer driven health plans in the U.S.
  • Per HR Brew,
    • “Despite a softening job market, US employers are expected to grant merit increases of 3.3% to non-unionized employees in 2025—the same rate as this year, according to a report by Mercer.
    • “It’s not surprising to us to see employers really kind of keeping up with the part of what they had done in the prior year,” said Jack Jones, principal consultant at Mercer. “I think what it shows is employers are still prioritizing the investment in their talent.”
    • “Next year, employers are expected to increase their total salary budgets—which includes money for promotions and adjustments to reach equity—to 3.7%, excluding unionized workers. The increase was 3.6% for this year. About one-tenth (9.3%) of employees are expected to receive promotions next year, compared to 8% in 2024.
    • “However, Jones noted the numbers could change because only 20% of the more than 850 organizations surveyed had finalized their budgets. Still, most organizations (69%) don’t expect to adjust their initial projections.”

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, HSA, Medical / Rx research, Mental health care, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The Washington Post reports,
    • “In a flurry of Friday night announcements, President-elect Donald Trump said he had selected Scott Bessent, a financier who embraced MAGA, to head the Treasury Department; Russell Vought, a Project 2025 contributor, to run the White House budget office again; and Rep. Lori Chavez-DeRemer (R-Oregon) [who lost her bid for re-election] for labor secretary. The president-elect also said he had selected Janette Nesheiwat, a Fox News contributor, to serve as surgeon general; and former congressman Dave Weldon to head the Centers for Disease Control and Prevention.”
  • The HHS, Labor, and Treasury Secretaries are the principal Affordable Care Act regulators while the Office for Management and Budget carriers a lot of weight with the Office of Personnel Mangement.
  • The American Hospital Association News tells us,
    • “The AHA and 22 other organizations Nov. 22 urged Congress to pass an end-of-year health care package that includes action on alternative payment models and a scheduled physician payment cut. The organizations requested an extension of Medicare’s Advanced Alternative Payment Model incentive payments, ensure that APM qualifying thresholds remain attainable and replacement of a scheduled cut to Medicare physician payments with an update reflective of inflationary pressures.
    • “These payment reforms have generated more than $28 billion in gross savings for Medicare over the past decade,” the organizations wrote. “The Centers for Medicare & Medicaid Services (CMS) recently released results showing that the Medicare Shared Savings Program and [Accountable Care Organization] REACH Model, the largest APMs in Medicare, generated $2.8 billion in net savings for the Medicare program in 2023, while improving patient access and quality.”  
  • HHS’s HRSA shares information on federal government spending to improve rural healthcare.
  • Per MedTech Dive,
    • “The Food and Drug Administration’s medical device center unveiled Thursday a pilot program meant to speed up notices to the public about potentially high-risk product recalls.
    • “The pilot aims to improve the time between when the FDA first knows about certain corrective actions on products and when the public and healthcare providers are notified. The actions include when companies remove products from the market, correct products or update use instructions due to potentially high safety risks.
    • “The program will provide “early alerts” of potentially high-risk device removals or corrections related to cardiovascular, gastro renal, general hospital, obstetrics and gynecology and urology, according to the FDA’s Center for Devices and Radiological Health. The center added, “At this time, there is no change to any other recall process or recall communication timelines for other areas.”
    • “Michelle Tarver, the new CDRH director, said in a statement that the program is meant to increase transparency.”
  • Kevin Moss writing in Federal News Network offers an Open Season checklist for federal employees while FedWeek shares “11 FAQs: Open Season & PSHB/FEHB Switchover.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is stable or declining in most areas. Seasonal influenza activity remains low nationally. RSV activity is elevated and continues to increase in the southern, central, and eastern United States, particularly in young children. Respiratory infections caused by the bacterium Mycoplasma pneumoniae remain elevated among young children in the United States.
    • “COVID-19
      • “Nationally, COVID-19 activity is stable or 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. COVID-19 activity is low with no meaningful changes in infection levels predicted.
      • “CDC expects that the 2024-2025 COVID-19 vaccine will work well for currently circulating variants. 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
      • “RSV activity is elevated and continues to increase in the southern and eastern United States. Activity is low in the rest of the country but increasing in the central and western United States. Emergency department visits and hospitalization rates are increasing in young children in the southern, central, and eastern United States.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections afforded by vaccines.”
  • The University of Minnesota’s CIDRAP tells us,
    • “The US Centers for Disease Control and Prevention (CDC) said today that its tests have confirmed H5N1 avian flu in California’s recent suspected case, involving a child who had no known exposure to infected animals.
    • “Also, California announced another confirmed H5 case in a dairy farm worker. The new developments lift the state’s total to 29 human cases of H5 avian flu and the national total since the first of the year to 55.” * * *
    • “The child is recovering, and all family members tested negative for H5 avian influenza but positive for the same common respiratory virus as the child. Contact tracing continues, and there is no sign of human-to-human spread.
    • “Investigation into the child’s exposure to H5N1 is still under way, the CDC said.”
  • The New York Times reports,
    • “The number of deaths caused by alcohol-related diseases more than doubled among Americans between 1999 and 2020, according to new research. Alcohol was involved in nearly 50,000 deaths among adults ages 25 to 85 in 2020, up from just under 20,000 in 1999.
    • “The increases were in all age groups. The biggest spike was observed among adults ages 25 to 34, whose fatality rate increased nearly fourfold between 1999 and 2020.
    • “Women are still far less likely than men to die of an illness caused by alcohol, but they also experienced a steep surge, with rates rising 2.5-fold over 20 years.
    • “The new study, published in The American Journal of Medicine, drew on data from the Centers for Disease Control and Prevention.”
  • A Wall Street Journal reporter observes
    • “After years of pushing the benign myth that a glass of wine a day is good for the heart, it seems the medical establishment has abandoned hedonists and pleasure seekers. Is there a safe amount of alcohol? It turns out no. 
    • “For this and other more amorphous reasons, I have noticed increasing numbers of people around me are sober-ish. They drink only socially or only two glasses of wine a week or only in restaurants. They are not willing to give up drinking entirely, which feels like too vast and depressing a surrender of life’s pleasures. So they make rules for themselves. 
    • “Someone I know has a new ritual of drinking a nonalcoholic beer with nuts on her terrace. Another friend told me that she used to drop by for drinks at friends’ houses in the evenings, and now it is just as often tea.”
  • Medscape discusses the side effects of GLP-1 drugs.
    • “Just a few years after some TikTok videos spiked the demand, one in eight US adults has tried Ozempic (semaglutide) or another drug in its class. Glucagon-like peptide 1 (GLP-1) receptor agonist medications have revolutionized obesity medicine.
    • “But they’re not without problems. In the early days of the social media craze, news reports often featured patients whose gastrointestinal side effects sent them to the emergency room (ER).
    • “It happened a lot then. Patients didn’t want to complain because they were losing weight, and they wound up in the ER with extreme constipation or a small bowel obstruction,” said Caroline Apovian, MD, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.
    • “But that’s not really happening now,” she added.
    • “Research backs up her assertion: A recent clinical review of studies found that many patients still experience side effects, but only at a mild to moderate level, while the dosage increases — and the unpleasantness tapers with time. Roughly 7% of patients discontinue the medications due to these symptoms.”
  • KFF provides findings from its 2024 Women’s Health Survey concerning contraception.
  • Medical Economics informs us,
    • “More than one in five U.S. adults, which equates to 59.3 million people, were living with mental illnesses in 2022, yet just more than half of them (50.6%) had received treatment in the previous year. A new study, from West Health and Gallup, uncovered that 70% of Americans would prefer to be asked about both their physical health and their mental health during appointments with their primary care providers (PCPs).
    • ‘The West Health-Gallup Survey on Mental Health in America reported that 65% of men and 76% of women hoped to discuss both physical and mental health with their PCPs. The survey also found that 66% of U.S. adults have been asked about their mental health by their PCPs or family practitioners, whereas 32% of adults said that had never happened. Women were more likely than men (71% compared to 60%) to be asked about mental health.”
  • The University of Minnesota’s CIDRAP lets us know,
    • “Yesterday, the US Centers for Disease Control and Prevention (CDC) closed its investigation into the multistate Listeria outbreak tied to Boar’s Head deli meat after 61 cases and 10 deaths were reported.”
  • The Food and Drug Administration announced,
    • “On Thursday, the FDA updated the outbreak advisory for E. coli O21:H19 infections linked to organic whole and baby carrots supplied by Grimmway Farms. The retail-packaged organic whole carrots were in stores for purchase from August 14 through October 23, 2024. The organic baby carrots have different best-if-used-by-dates ranging from September 11 through November 12, 2024. The update includes information about recalled product being distributed to markets outside the United States and additional recalls from companies that may have used or repackaged recalled carrots from Grimmway Farms. FDA’s investigation remains ongoing.”
  • The Washington Post reports,
    • “The Detroit-based Wolverine Packing Co. recalled more than 167,000 pounds of ground beef products because of concerns that the meat may be contaminated with E. coli, according to the U.S. Department of Agriculture. The recall affects fresh products that have a use-by date of Nov. 14 and frozen products whose labels contain a production date of Oct. 22, officials said.
    • “On Nov. 13, Minnesota’s Department of Agriculture alerted the Food Safety and Inspection Service, an agency of the USDA, about a group of people who had consumed ground beef before they fell ill.
    • ‘On Nov. 20, a ground beef sample collected by Minnesota officials tested positive for E. coli O157. Federal officials determined that the products from Wolverine Packing Co. were linked to the people who had become sickened in Minnesota.
    • “At least 15 patients have been identified, and the onset of their infections range from Nov. 2 to Nov. 10, the USDA said. At least two have been hospitalized, according to Minnesota officials.
    • “The recalled products have the establishment number EST. 2574B inside the USDA mark of inspection. The items were shipped to restaurant locations nationwide, according to officials.
    • Some products may be in restaurant refrigerators or freezers, officials said.
    • “Restaurants are urged not to serve these products.”

From the U.S. healthcare business front,

  • HR Dive relates,
    • “Insurers are projecting medical costs will increase globally in 2025 — by about 10.4%, according to WTW’s 2025 Global Medical Trends Survey.
    • “Specifically in the U.S., insurers project a 10.2% increase in 2025, up from 9.3% this year.
    • “Notably, WTW researchers said that public healthcare systems worldwide have been overwhelmed due to high demand and low resources, which has led to people turning to private providers.”
  • Health Leaders Media discusses an Oschner Health program with myLaurel which offers value-based medical care at home.
    • “Billing arrangements are a key difference between CMS’ Acute Hospital Care at Home program and Ochsner Health’s Acute Care at Home program.
    • “The Acute Care at Home program features virtual visits with physicians, nurses, and care managers as well as in-person visits with paramedics.
    • “By reducing hospital admissions and readmissions, the Acute Care at Home program is decreasing total cost of care.”
  • Investment News reports,
    • “Despite the benefits of health savings accounts as tax-advantaged retirement savings tools, employees are largely using them to meet current healthcare expenses, according to a new survey by the Plan Sponsor Council of America.
    • “The 2024 HSA Survey, sponsored by HSA Bank, reflects responses from more than 500 employers and shows modest growth in account balances and contributions. However, it also highlights a need for greater education around the long-term benefits of HSAs.
    • “While 90 percent of eligible employees had an HSA in 2023 and three-quarters made contributions, few are leveraging them for retirement planning.
    • “Among other key insights, the survey found that only one-third of employers educate workers about using HSAs as part of their retirement strategies, and fewer than 30 percent allow participants to view their HSA balances alongside retirement accounts for a more holistic view of savings. Less than 10 percent of employers mirror HSA investment options with those available in their 401(k) plans, though interest in doing so has grown.”
  • The Wall Street Journal reports,
    • “An industry fight against lucrative drug discounts for hospitals is intensifying as another drugmaker joins the battle: Sanofi.
    • “The pharmaceutical company plans to change its policy on how it gives discounts to certain hospitals. Sanofi will require institutions to provide pharmacy and medical claims information before receiving federally mandated discounts. The company sent a letter, which was viewed by The Wall Street Journal, to hospitals outlining its new model on Friday, according to people familiar with the matter. 
    • “The French company’s plan, which would take effect early next year, comes as the industry escalates its efforts to rein in the federal program known as 340B. Eli Lilly and Johnson & Johnson this month filed separate lawsuits against the federal government for rejecting the companies’ plans to tighten the way they provide the discounts to hospitals in the program.” 
  • Per BioPharma Dive,
    • “Medtronic received Food and Drug Administration clearance for its new InPen smart insulin pen app that can recommend corrections for missed or inaccurate insulin doses at mealtime.
    • “The authorization paves the way for the launch of Medtronic’s Smart MDI system, which combines InPen with the Simplera continuous glucose monitor (CGM), the company said Wednesday. 
    • “With the clearance, Medtronic said Smart MDI will be the first system on the market to provide personalized insights on when and how much insulin to dose in real-time for people who take multiple daily injections.”

Monday Round up

David Ermer–CDC, FDA, Federal employment benefits, Generative AI, HSA, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Federal News Network Interviews Consumer Checkbook’s Kevin Moss “on how a little planning can offset rise in premium costs” when selecting an FEHB or PSHB plan for 2025.
  • KFF examines Plan Offerings, Premiums and Benefits in Medicare Advantage Plans During the Medicare Open Enrollment Season for Coverage in 2025.
  • The American Hospital Association tells us,
    • “To recognize National Rural Health Day Nov. 21, AHA has released a blog and infographic that address challenges in accessing rural behavioral health care and approaches to solving them, respectively. From Nov. 18-22, AHA will honor our rural workforce by sharing rural health content through AHA Today, social media and other channels.” 
  • The Congressional Research Service released a Focus report about the qualified medical expenses that health savings account (“HSA”) holders can use the HSA to pay.
  • BioPharma Dive lets us know,
    • “Massachusetts-based Syndax Pharmaceuticals won Food and Drug Administration approval Friday for a new kind of drug to treat an aggressive form of leukemia in adults and some children.
    • “The oral drug, which Syndax will sell as Revuforj, is the first of its type, a class of compounds known as menin inhibitors. It’s cleared for patients one year or older who have relapsed or refractory acute leukemia that harbors a specific mutation: translocations in the lysine methyltransferase 2A, or KMT2A, gene.
    • ‘People with this type of leukemia are more likely to relapse and have a median overall survival of less than one year. Syndax plans to launch two doses of the drug, which it priced at about $475,000 per year before rebates or discounts, later in November. A lower dose for patients who weigh less will be available next year.”

The public health and medical research front,

  • The New York Times reports,
    • “One of the first warnings came in a paper published in 2021. There was an unexpected rise in pancreatic cancer among young people in the United States from 2000 to 2018. The illness can be untreatable by the time it is discovered, a death sentence.
    • “With publication of that report, by Dr. Srinivas Gaddam, a gastroenterologist at Cedars-Sinai Medical Center, researchers began searching for reasons. Could the increase be caused by obesity? Ultraprocessed foods? Was it toxins in the environment?
    • “Alternatively, a new study published on Monday in The Annals of Internal Medicine suggests, the whole alarm could be misguided.
    • “The authors of the paper, led by Dr. Vishal R. Patel a surgical resident at Brigham and Women’s Hospital in Boston, did not dispute the data showing a rising incidence. They report that from 2001 to 2019 the number of young people — ages 15 to 39 — diagnosed with pancreatic cancer soared. The rate of pancreatic surgeries more than doubled in women and men.
    • “The problem is that the expected consequence of such a rise in cancers did not occur. With more pancreatic cancers in young people, there should be more pancreatic cancer deaths. And there were not. Nor were more young people getting diagnosed with later-stage cancers. Instead, the increase was confined to cancers that were in very early stages.
    • “Many cancers will never cause harm if left alone, but with increasingly sensitive tools, doctors are finding more and more of them. Because there usually is no way to know if they are dangerous, doctors tend to treat them aggressively. But they would never have shown up in death statistics if they had not been found.
    • “It’s the hallmark of what researchers call overdiagnosis: a rise in incidence without a linked rise in deaths.”
  • STAT News informs us
    • “At the Milken Institute’s Future of Health Summit on Thursday, researchers and health care executives talked about efforts to detect cancers earlier, save lives, and get to the root of why cancers have begun to rise in this population. 
    • “The big question is always why,” said Kimryn Rathmell, director of the National Cancer Institute. “We need to understand the variation so that we can begin to understand which parts are related to obesity, diet and exercise; which ones are more related to sun exposure, smoking, alcohol — the risk factors that are well-known to us, but may have a variation in how they’re being consumed or exposed in younger people today.” * * *
    • “Since cancer is still rare among younger adults, people are likely to get negative test results. That “runs the risk of people, by the time they get older, kind of shrugging their shoulders and saying, ‘Well, I’ve been doing this for 10 years, why should I keep doing it?’” said Harlan Levine, president of health innovation and policy at the City of Hope.
    • “Part of the solution, the group agreed, is to develop more efficient, targeted tests that can detect cancers earlier on. Mohit Manrao, the head of U.S. oncology at AstraZeneca, noted that the company has recently developed an AI tool that can use biomarkers from common hospital tests to predict the likelihood that a person will get a disease, including some cancers, before a doctor would be able to make a diagnosis.
    • “It’s also important to expand outreach to populations that haven’t had access to it in the past. Black women, for example, have a lower incidence of breast cancer than white women but 40% higher chance of dying from it.”
  • and
    • “Lipoprotein(a) is a risk factor for cardiovascular disease you may not hear about in your annual physical. Like LDL, or “bad” cholesterol, too much of the LDL-like particle can create plaque that clogs arteries, creating potential blockages that lead to heart attacks or strokes. It’s also implicated in aortic stenosis, when the aortic valve narrows, pinching blood supply to the rest of the body.
    • “But unlike cholesterol, Lp(a) does not surrender to statins or respond to a healthier lifestyle of improved diet and more physical activity. Its levels are determined by your genes, putting the estimated 1 in 5 people who have high levels at a two- or threefold higher risk than people without what’s called the most common genetic dyslipidemia. In the United States, that would mean 64 million people are at risk and 1.4 billion people worldwide.
    • “At the American Heart Association’s scientific sessions Monday, researchers presented Phase 2 data on two treatments for elevated Lp(a): an oral drug called muvalaplin and an RNA-silencing injection called zerlasiran. Both studies were also published in JAMA and include several of the same co-authors, led by Steven Nissen of the Cleveland Clinic and Stephen Nicholls of Monash University.
    • “These two new reports add to the growing evidence in at least five different drug programs directed for lowering Lp(a) that the agents are potent, capable of 80% reduction or more, with durable effects over extended treatment,” said Eric Topol, cardiologist and geneticist and director of the Scripps Research Translational Institute. He was not involved in either study. “Most of the programs are siRNA injectables but one here is oral, which is encouraging, more practical, and may be less expensive.”
  • Per Medscape,
    • “Artificial intelligence (AI) helps produce echocardiograms more quickly and efficiently, with better-quality images and less fatigue for operators, shows the first prospective randomized controlled trial of AI-assisted echocardiography.
    • “The Japanese study used Us2.ai software, developed from an 11-country research platform and supported by the Singapore Agency for Science, Technology and Research. This system and another newly developed AI system, PanEcho — developed at the Yale School of Medicine in New Haven, Connecticut, and the University of Texas at Austin — can automatically analyze a wide range of structures, functions, and cardiographic views. Studies of these two systems were presented at the American Heart Association (AHA) Scientific Sessions 2024.“
  • Per MedPage Today,
    • “More than half of all adults in the U.S. are eligible for semaglutide (Ozempic, Wegovy, Rybelsus), researchers estimated.
    • “Among 25,531 participants in the National Health and Nutrition Examination Survey (NHANES) from 2015 to 2020, 8,504 were eligible for semaglutide, representing an estimated 136.8 million adults across the country. All met the criteria for at least one of three indications that the drug is currently approved for — diabetes, weight management, or secondary cardiovascular disease (CVD) prevention, reported Dhruv S. Kazi, MD, MSc, of Beth Israel Deaconess Medical Center in Boston, and colleagues.”
  • The Washington Post adds,
    • “From August 2021 to August 2023, 4.5 percent of adults in the United States had undiagnosed diabetes, the Centers for Disease Control and Prevention says in a recent report. And a little over 11 percent of U.S. adults had been diagnosed with the condition as of the same time period, the CDC says.” * * *
    • “The study looked at how total, diagnosed and undiagnosed diabetes differed across demographics including age, weight and educational attainment. Undiagnosed diabetes prevalence increased with age. For example, about 1.3 percent of adults ages 20 to 39 with diabetes were undiagnosed vs. 5.6 percent of those 40 to 59. Among those 60 and older, some 6.8 percent of people with diabetes had not been diagnosed.”
  • The American Medical Association shares “what doctors wish patients knew about sciatica.”
  • Per BioPharma Dive,
    • “A single infusion of a CRISPR therapy developed by Intellia Therapeutics showed promising signs of stabilizing a heart disorder caused by the rare disease transthyretin amyloidosis, buoying the company’s hopes of finding success in late-stage clinical trials.
    • “Phase 1 study data from 36 people with the cardiomyopathy form of transthyretin, or ATTR, amyloidosis showed Intellia’s gene editing treatment sharply and durably lowered levels of the ATTR protein that misfolds and gathers in the toxic clumps that characterize the disease.
    • “Prior trial results, in fewer people and across shorter periods of time, had already shown Intellia’s therapy capable of reducing ATTR protein. The new findings, which were published Friday in The New England Journal of Medicine, show those reductions appeared to translate to stability or improvement on several markers of cardiac disease progression, too.”
  • Per a National Institutes of Health press release,
    • “Researchers from the National Institutes of Health (NIH) have developed an artificial intelligence (AI) algorithm to help speed up the process of matching potential volunteers to relevant clinical research trials listed on ClinicalTrials.gov. A study published in Nature Communications(link is external) found that the AI algorithm, called TrialGPT, could successfully identify relevant clinical trials for which a person is eligible and provide a summary that clearly explains how that person meets the criteria for study enrollment. The researchers concluded that this tool could help clinicians navigate the vast and ever-changing range of clinical trials available to their patients, which may lead to improved clinical trial enrollment and faster progress in medical research.
    • “A team of researchers from NIH’s National Library of Medicine (NLM) and National Cancer Institute harnessed the power of large language models (LLMs) to develop an innovative framework for TrialGPT to streamline the clinical trial matching process. TrialGPT first processes a patient summary, which contains relevant medical and demographic information. The algorithm then identifies relevant clinical trials from ClinicalTrials.gov for which a patient is eligible and excludes trials for which they are ineligible. TrialGPT then explains how the person meets the study enrollment criteria. The final output is an annotated list of clinical trials—ranked by relevance and eligibility—that clinicians can use to discuss clinical trial opportunities with their patient.
    • “Machine learning and AI technology have held promise in matching patients with clinical trials, but their practical application across diverse populations still needed exploration,” said NLM Acting Director, Stephen Sherry, PhD. “This study shows we can responsibly leverage AI technology so physicians can connect their patients to a relevant clinical trial that may be of interest to them with even more speed and efficiency.”
    • “To assess how well TrialGPT predicted if a patient met a specific requirement for a clinical trial, the researchers compared TrialGPT’s results to those of three human clinicians who assessed over 1,000 patient-criterion pairs. They found that TrialGPT achieved nearly the same level of accuracy as the clinicians.”
  • Per Healio,
    • “Most people at high risk for lung cancer have not discussed screening for the disease with their clinician or have even heard of the test, according to a research letter published in JAMA Network Open.
    • “The findings come despite lung cancer screening demonstrating effectiveness at identifying cancer and reducing related mortality outcomes, a researcher pointed out.
    • “We’ve got a screening test that works. It works as well, if not better, than breast and colorectal cancer screening in terms of mortality reduction. It’s one of the most life-saving things we have for a cancer that kills more people than either of those two combined,” Gerard A. Silvestri, MD, MS, FCCP, a professor of medicine at the Medical University of South Carolina (MUSC) and the study’s senior author, said in a press release.
    • “Silvestri and colleagues noted that physician-patient communication is vital for the uptake of lung cancer screening, which only 18% of eligible patients are up to date on, according to a prior study published in JAMA Internal Medicine.”

From the U.S. healthcare business front,

  • Healthcare Dive reflects,
    • “Despite growing revenues, most major insurers saw their profits from offering health plans shrink in the third quarter as pressures in government programs stretched into the back half of the year.
    • “In Medicare Advantage, seniors are still utilizing more healthcare than insurers expected when pricing their plans. And in Medicaid, states’ payment rates continue to land well below the cost of caring for beneficiaries in the safety-net programs, payers say.
    • “Those forces coalesced to hit insurers, slamming some — notably, CVS-owned Aetna and Humana — while swatting others. Aetna was particularly affected, posting the steepest year-over-year drop in operating profit by a wide margin.
    • “Only two insurers — Cigna and Molina — reported a year-over-year increase in operating profit from insurance arms: Cigna, because most of its members are in commercially insured plans, which shelters the payer from headwinds in government plans; and Molina due to risk corridors that absorbed the worst of unexpected cost trends, and rate updates from Medicaid states. 
    • “Yet overall, medical loss ratios — an important metric of spending on patient care — increased 3.3 percentage points year over year when averaged across the seven major publicly traded payers. That’s a major leap. Again, Aetna saw the most drastic change — and management warned investors the MLR could increase further, from 95.2% this quarter to 95.5% in the fourth.”
  • The Wall Street Journal adds,
    • “CVS Health is adding four new members to its board in an agreement with Glenview Capital Management, a hedge fund that pushed for changes at the healthcare company.
    • “The new members include Glenview Chief Executive Larry Robbins, as well as three other executives with health-sector and financial experience. The board’s total membership will be 16 with the new additions.
    • ‘Robbins and CVS Executive Chairman Roger Farah said the company and the investor had agreed to cooperate. 
    • “The board members that are joining bring unique skills, they’ll be additive to the existing board, and we expect to work collaboratively,” Farah said in an interview.”
  • Beckers Hospital Review offers eight predictions about hospital financial stability in 2025 based ona a November 13 report issued by Moody’s Investor Services.
  • Modern Healthcare reports,
    • “Ascension Wisconsin plans to close a hospital in Waukesha and consolidate a few lines of service among other facilities in the southeast region of the state.
    • “The Waukesha “micro-hospital,” which offers emergency and low-acuity care services, is slated to shut down in January, said Ascension Wisconsin Senior Director of External Relations Mo Moorman on Monday.
    • “The facility is part of a joint venture between Glendale-based Ascension Wisconsin and micro-hospital developer Emerus, which staffs and manages the location. The decision to close was due to consistently low patient volumes, Moorman said.
    • “Other facilities run by the joint venture will not be affected.”

Midweek Update

David Ermer–CDC, Congress, Federal employment benefits, Generative AI, HSA, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Roll Call reports,
    • “Sen. John Thune [R SD] on Wednesday was elected the next Senate majority leader, as Republicans are set to take over the chamber in January — and with a demanding President-elect Donald Trump poised to return to power.
    • “Having defeated Texas Sen. John Cornyn and Florida Sen. Rick Scott, the fourth-term South Dakotan will replace Mitch McConnell of Kentucky in January as the chamber’s top Republican. McConnell had held the top GOP spot since taking his party’s leadership reins in early 2007, making him minority leader in six Congresses and majority leader in three Congresses.
    • “Thune defeated Cornyn 29-24 on the day’s second ballot, with Scott eliminated from contention after the first ballot, according to a source inside the Capitol’s Old Senate Chamber, where Republicans chose their next leader.
    • “Senate Republicans also selected Sens. James Lankford, R-Okla., as Republican Conference vice chair; Shelley Moore Capito, R-W.Va., as Republican Policy Committee chair; John Barrasso, R-Wyo., as assistant majority leader; Tim Scott, R-S.C., as National Republican Senatorial Committee chair; and Tom Cotton, R-Ark., as Republican Conference chair.”
  • Tuesday night, the AP results for control of the House now stand at 218 Republicans vs. 208 Democrats with 218 seats constituting a majority. Decision Desk HQ already had awarded control of the House to the Republicans, 219 Republicans vs. 211 Democrats.
  • Federal News Network lets us know,
    • “The House passed the Social Security Fairness Act Tuesday evening in a vote of 327 to 75, bringing the removal of the Windfall Elimination Provision and the Government Pension Offset closer than ever to reality.
    • “Social Security’s WEP and GPO have been around for decades. The two provisions reduce and, in some cases, fully cancel out Social Security benefits for Civil Service Retirement System annuitants and other public sector employees who have worked in state and local government, as well as their spouses, widows and widowers.
    • “The House’s vote came after Reps. Abigail Spanberger (D-Va.) and Garret Graves (R-Pa.), the original cosponsors of the reintroduced Social Security Fairness Act, filed a discharge petition in September to try to push the bill toward a vote. About one week later, the petition reached the 218-signature threshold needed to force the bill to the House floor.” * * *
  • OPM yesterday released a fact sheet titled OPM Highlights its Key Actions under Biden Administration’s AI Executive Order.
  • Govexec tells us,
    • “The Office of Personnel Management reported a slight increase in the backlog of pending federal employee retirement claims in October, though still a marked improvement from the same period last year.
    • “OPM received 6,872 new retirement requests from departing federal workers last month, an increase of around 1,250 more claims than in September. Though OPM cleared 6,458 claims—itself an increase of around 150 claims from the previous month—the backlog ticked up by around 400 cases to 14,908. OPM’s goal is a “steady state” of 13,000 pending retirement claims.
    • “Despite that, the average time it takes to process a retirement claim fell from 63 to 62 days, as measured on a monthly basis.” * * *
    • Now the legislation faces its next hurdle: passage in the Senate. The Senate’s companion to the Social Security Fairness Act currently has 62 cosponsors. * * *
    • “Unlike the House, the Senate does not have a discharge petition procedure — the strategy that Spanberger and Graves used to force the floor vote in the House.
    • “In the Senate, we have the votes to defeat a filibuster, but it has to be brought to a vote,” John Hatton, NARFE’s staff vice president of policy and programs, told The Federal Drive with Tom Temin. “But somebody may object to proceeding, which could cause a two-week or so delay in getting it through.”
  • Per a government press release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the U.S. Department of Health and Human Services (HHS), announced today the launch of the Behavioral Health Workforce Career Navigator, designed to help current and aspiring behavioral health professionals identify state requirements for a range of behavioral health careers. The navigator supports President Biden and Vice President Harris’ commitment to expanding America’s behavioral health workforce, a key element of the Administration’s Unity Agenda for the Nation.”

From the public health and medical research front,

  • National Institutes of Health Director Dr. Monica Bertagnolli writes in her blog, about “Advancing a Whole-Person Approach to Women’s Health Research.”
    • “NIH has committed $200 million in fiscal year 2025 to supporting cross-cutting research focused on the health needs of women. We also issued a Notice of Special Interest to highlight our interest in receiving project applications on diseases and conditions that impact women differently, disproportionately, and uniquely across nearly all NIH Institutes and Centers. We are already considering close to 300 new applications for women’s health research projects.
    • “The whole-person approach to women’s health allows researchers and clinicians to address unique needs throughout a woman’s lifetime and to provide a more complete picture of women’s health. It also must be integrated into all stages of the research process—from identifying innovative research questions, to producing impactful scientific and clinical results, to developing ways to equitably adopt new treatments. It begins with science that convenes researchers and clinicians from different disciplines to accelerate progress through combined efforts and knowledge. The White House Initiative on Women’s Health Research calls for this comprehensive approach, renewing NIH’s commitment to research that addresses the needs of women everywhere. It demands that we approach this work with urgency, putting women and their lived experiences at its center of a focus on translating insights from biology and society into better health.
    • “Links:
  • The Washington Post reports,
    • “A Canadian teenager infected with bird flu — that country’s first case involving a locally acquired infection — is in critical condition and experiencing difficulty breathing, health officials said Tuesday.
    • “The previously healthy British Columbia teen went to a hospital emergency room Nov. 2 with initial symptoms of pink eye, fever and cough, conditions common to many respiratory illnesses, Bonnie Henry, provincial health officer, said during a news conference. The teen was sent home.
    • “But after the patient’s condition deteriorated, the teen was admitted to BC Children’s Hospital in Vancouver late Friday.
    • “So far, no one who came into contact with the teen has fallen ill.” * * *
    • “On Wednesday, the Public Health Agency of Canada confirmed the H5N1 diagnosis in the teen and said genomic sequencing indicates the virus is related to the bird flu viruses from the ongoing outbreak in poultry in British Columbia, which is related to wild birds.”
  • STAT News informs us,
    • “U.S. drug overdose deaths are plummeting, putting the country on pace for its first year with fewer than 100,000 overdose deaths since 2020 — a powerful, if bleak, symbolic milestone.
    • “Reported drug deaths fell nearly 17% during the 12-month period ending in June, to 93,087, according to new statistics released this week by the Centers for Disease Control and Prevention. 
    • “The epidemic’s toll remains immense but is substantially lower than the 111,615 lives lost to overdose during the 12 months ending in June 2023. Fentanyl, the potent illicit opioid that now dominates the U.S. illicit drug supply, contributed to a large majority.” 
  • Per Health Day,
    • “Even as the pressures of the pandemic began to ebb, Americans’ growing dependence on alcohol did not, a troubling new study shows.
    • “Two years into the globe-altering health crisis, the percentage of Americans who consumed alcohol — which had already spiked between 2018 and 2020 — inched even further up in 2021 and 2022. Not only that, but more folks reported heavy or binge drinking, the findings published Tuesday in the Annals of Internal Medicine revealed.
    • “Our results provide national data to draw further attention to the potential alcohol-related public health effects that may remain from the pandemic,” the researchers wrote in their research. “Potential causes of this sustained increase include normalization of and adaptation to increased drinking due to stress from the pandemic and disrupted access to medical services.” 
  • Per MedTech Dive,
    • “Livanova said Monday a trial of its obstructive sleep apnea (OSA) implant met its primary safety and efficacy endpoints, positioning the company to seek approval once the analysis is complete.  
    • “The randomized trial linked Livanova’s aura6000 to improvements on measures of OSA severity and blood oxygen after six months of treatment with the hypoglossal nerve stimulator. The hypoglossal nerve controls the tongue muscles.
    • “Leerink Partners analysts said the results were largely in line with outcomes seen in a trial of Inspire Medical Systems’ rival device. The analysts see ways that Livanova could differentiate its device but said the company “may have a difficult time breaking into the sleep apnea market.”
  • Fierce Pharma points out,
    • “Following an impressive data drop this summer highlighting the potential for Eli Lilly’s tirzepatide to stave off progression to Type 2 diabetes in prediabetic patients, the Indianapolis-based drugmaker is laying out full results from its longest completed study of the dual GIP/GLP-1 receptor agonist to date.
    • “In the three-year SURMOUNT-1 trial, tirzepatide curbed the risk of disease progression to Type 2 diabetes by 94% versus placebo in adult prediabetes patients who were obese or overweight, Lilly said in a release Wednesday. The number represents a pooled result from three tirzepatide doses (5 mg, 10 mg and 15 mg) studied in the trial.
    • “Putting those results into perspective, one new case of diabetes could be prevented for every nine patients treated with tirzepatide, which is marketed in the U.S. as Mounjaro for Type 2 diabetes and as Zepbound for obesity, Lilly said.
    • “Overall, nearly 99% of patients on tirzepatide remained diabetes-free at the end of the trial’s 176-week treatment period, the company added. 
    • ‘Further, at the 193-week mark, which followed a 17-week off-treatment follow-up period, only 2.4% of patients on Lilly’s drug were diagnosed with Type 2 diabetes compared to 13.7% of patients in the study’s placebo cohort.
  • Beckers Hospital Review identifies “nine new drug shortages to know, according to databases compiled by the FDA and the American Society of Health-System Pharmacists.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Self-funded employer clients of Aetna have access to SimplePay Health, a new healthcare plan design that provides employees and other plan members with essentially an interest-free line of credit to pay for care and requires no out-of-pocket costs due at the time of service, Aetna said in a Oct. 15 press release.
    • “The plan requires only copays for medical services and prescription drugs up to the plan member’s out-of-pocket maximum, with no deductibles or coinsurance costs. Each plan member is mailed a monthly statement — which Aetna compared to a credit card statement — that summarizes all medical and pharmacy claims from the prior 30 days.
    • “Payment terms are generally chosen by the plan sponsor, Amie Benedict, president, diversified commercial solutions at Aetna, said in an email to HR Dive, but payment plans are generally between 12 to 18 months long. “SimplePay will work with members requiring longer payment periods,” Benedict said.” * * *
    • “Aside from SimplePay, UnitedHealthcare company Surest also offers a plan model to self-funded employers without coinsurance or deductibles.
    • “Jim Winkler, chief strategy officer at the Business Group on Health, said in an interview that SimplePay, Surest and similar products are designed to curate a set of preferred healthcare providers and encourage plan members to use these providers by keeping down out-of-pocket costs.
    • “This is especially the case for “shoppable” care, or care that is neither urgent nor emergency in nature and for which employees can select from a variety of providers, Winkler said. “In these shoppable moments, these programs are designed to ensure that the right choice is the easy choice.”
  • Fierce Healthcare fills us in on the first day of its Fierce Health Payer Summit here in beautiful Austin Texas.
  • Corporate Synergies exposes “The Myths Preventing Employees from Embracing HSA-Qualified Plans.”
  • Per BioPharma Dive,
    • “BioNTech is buying into one of the hottest areas of oncology, agreeing to pay $800 million to acquire China-based Biotheus and, with it, a type of drug some analysts think could rival Merck & Co.’s dominant immunotherapy Keytruda.
    • “The deal will hand BioNTech full global rights to a dual-targeting drug that’s designed to block two proteins: the PD-L1 “checkpoint” targeted by Keytruda and another called VEGF that’s coopted by tumors to fuel their growth.
    • “This specific type of “bispecific antibody” is newly on drugmakers’ radar screens after Summit Therapeutics wowed the cancer field with data showing its drug ivonescimab outperformed Keytruda in a head-to-head lung cancer trial.”

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.”

Tuesday’s Tidbits

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

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.

Friday Factoids

David Ermer–CDC, FDA, HSA, Medical / Rx research, Mental health care, NIH, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association News reports,
    • “The U.S. Supreme Court June 28 overturned a 1984 ruling in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., which required courts to defer to federal agencies to interpret ambiguous laws. Decided by a 6-3 vote [written by Chief Justice Roberts], the Court held:
    • “Chevron is overruled. Courts must exercise their independent judgment in deciding whether an agency has acted within its statutory authority, as the Administrative Procedure Act requires. Careful attention to the judgment of the Executive Branch may help inform that inquiry. And when a particular statute delegates authority to an agency consistent with constitutional limits, courts must respect the delegation, while ensuring that the agency acts within it. But courts need not and under the APA may not defer to an agency interpretation of the law simply because a statute is ambiguous.”
  • FEHBlog observation: In short, the Supreme Court’s sensible, prospective decision creates a level playing field for American businesses and other citizens challenging administrative actions.
  • Fierce Healthcare tells us,
    • “Attorney General Merrick Garland announced Thursday [June 27, 2024,] a two-week operation in which 193 people across the country, including 76 licensed healthcare providers, were charged for their alleged participation in healthcare fraud schemes.
    • “The 145 cases highlighted by the Department of Justice (DOJ) involved over $2.75 billion of intended losses and $1.6 billion in actual losses, Garland said. Among allegations highlighted by the DOJ were medically unnecessary amniotic wound grafts, diverted HIV medications, online distribution of Adderall and other telemedicine schemes.
    • “As healthcare fraud schemes continue to evolve, so will the Justice Department’s investigative and prosecutorial strategies,” Garland said during a Thursday press conference. “Our messages to those seeking to exploit patients and defraud government programs is clear: You cannot hide your crimes. We will find you, and we will hold you accountable.”
  • Kauffman Hall reports,
    • “In late April, the Centers for Medicare & Medicaid Services (CMS) established new staffing standards for long-term care (LTC) facilities, mandating a minimum of 3.48 hours of nursing care per patient per day, with 33 minutes of that care from a registered nurse, at least one of whom must be always on site. The rule is slated to go into effect in two years for urban nursing homes and three years for rural nursing homes, with some facilities able to apply for hardship exemptions. 
    • “Although about one in five LTC facilities nationwide currently meet these staffing standards, staffing levels vary greatly by both state and facility ownership profile. In 28 states, fewer than a quarter of LTC facilities meet the new standards, and in eight states fewer than 10% of facilities are already in compliance. 
    • “Facilities in Texas are the least ready, with only 4% meeting the new staffing minimums. In terms of ownership structure, only 11% of for-profit facilities—which constitute nearly three quarters of all LTC facilities nationwide—have staffing levels that meet the new staffing minimums. 
    • “The Government Accountability Office projects this new rule will cost LTC facilities $43B over the first ten years, a significant expense at a time when recruiting and retaining nursing talent is already challenging. 
    • “Citing the risk of mass closures from facilities unable to comply, nursing home trade groups are suing to stop the mandate from going into effect, and there is also a bill advancing in the House that would repeal the staffing ratios. That bill is backed by the American Hospital Association, which fears the mandate “would have serious negative, unintended consequences, not only for nursing home patients and facilities, but the entire health continuum.”
  • HR Dive reminds us,
    • “While there’s still a small chance it could be blocked, the first step of the U.S. Department of Labor’s overtime final rule is set to go into effect Monday — raising the minimum salary threshold for overtime from $35,568 to $43,888.
    • “Almost every workplace should be prepared with needed adjustments, but there are still a few last-minute actions HR should undertake if they haven’t to protect their organizations, Victoria Lipnic, partner at Resolution Economics and former EEOC commissioner, and Jonathan Segal, partner at Duane Morris LLP, said at a Monday panel at the Society for Human Resource Management’s annual conference.”
    • The three items are explained in the article. 

From the public health and medical research front,

  • The Centers for Disease Control informs us,
    • “Summary
      • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in some areas.
    • COVID-19
      • During April and May 2024, COVID-19 activity was lower than at any time since the start of the pandemic. Recent increases need to be considered from that baseline. This includes increases in COVID-19 test positivity and emergency department visits, suggesting growth in COVID-19 activity across several states, and increases in rates of COVID-19–associated hospitalizations among adults 65+ at some Western sites. While there are indications for the potential start of a summer surge, nationally COVID-19 activity remains low. CDC will continue to monitor to see if these recent increases persist.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
    • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remained low for children and adults for the 2023-24 respiratory illness season. COVID-19 vaccines continue to be recommended and can provide a layer of protection.”
  • The Hill lets us know,
    • “The CDC recommended [on June 27, 2024] that all Americans 6 months and older receive the flu vaccine, noting that it will offer protection against the against H1N1, H3N2, and a B/Victoria lineage virus.
    • “And during the 2023-24 flu season, more than 44,900 people are estimated to have died from flu complications.
    • “The CDC emphasized that it was safe to receive the flu and COVID shots at the same time.”
  • Per MedTech Dive,
    • “Cepheid said Thursday it received de novo authorization for the only molecular test in the U.S. to detect hepatitis C virus RNA directly from fingerstick blood samples. 
    • “The Food and Drug Administration authorization positions healthcare professionals to diagnose hepatitis C at the point of care. The agency said that patients could be diagnosed and treated at the same healthcare visit.
    • “Cepheid’s authorization establishes special controls, clearing other companies to bring similar tests to market in the U.S. via the 510(k) pathway.” 
  • Fierce Pharma points out,
    • “After scoring approval as the world’s first pneumococcal disease vaccine made specifically for adults earlier this month, Merck’s Capvaxive passed the next test in its bid to take on Pfizer and its dominant Prevnar franchise.
    • “At a meeting this week, the CDC’s Advisory Committee on Immunization Practices (ACIP) gave a unanimous vote, with one abstention, in favor of the vaccine in millions of adults. Specifically, the vaccine experts recommended the shot for adults 65 and older who have not yet received a pneumococcal conjugate vaccine, plus for those 19 to 64 with certain underlying medical conditions or other risk factors.
    • “Adults 19 years old and up who have started their pneumococcal vaccine series with Pfizer’s Prevnar 13 but have not received all of the recommended Merck’s Pneumovax 23 doses are also included in ACIP’s endorsement.
    • “The ACIP vote recognizes the clinical profile of Capvaxive for adults in the U.S., and we look forward to the CDC’s final, published recommendations,” Merck’s chief medical officer Eliav Barr, M.D., said in a press release.
    • “Capvaxive protects against 21 serotypes of the bacterial infection that comprise 84% of the pneumococcal disease contracted by adults 50 and older, according to epidemiologic data from the CDC. Pfizer’s leading pneumococcal disease vaccine, Prevnar 20, protects against 20 serotypes that comprise 52% of the disease in that population.
  • The Institute for Clinical and Economic Review announced yesterday,
    • “ICER released a Final Evidence Report assessing the comparative clinical effectiveness and value of MDMA-assisted psychotherapy (MDMA-AP; Lykos Therapeutics) for the treatment of post-traumatic stress disorder (PTSD).
    • “ICER’s Chief Medical Officer David Rind, MD stated:
      • “PTSD can be a severe condition affecting nearly all aspects of an individual’s life, and many current therapeutic options are insufficient for many people with PTSD. Despite two randomized trials of MDMA-AP, functional unblinding in the trials and additional concerns around trial design and conduct led to ICER concluding that the publicly available evidence is insufficient to assess the balance of benefits and harms. It was encouraging to learn that FDA is investigating such issues, including those brought to light at our Public Meeting.”
    • “For every report, ICER follows a process that includes numerous opportunities for stakeholders to engage and be involved throughout its development. Our reports always begin with an initial scoping phase, followed by development of a Draft Evidence Report. We consider all of the public comments on the Draft Evidence Report as we put together the revised Evidence Report, which is discussed at a public meeting with patients, clinical experts, manufacturers, payers, and policy experts. After that public discussion, we release the Final Evidence Report.”
  • Per Health Day,
    • “An immunotherapy/chemotherapy combo drug can help early-stage breast cancer patients remain cancer-free following treatment, a new trial shows.
    • “The combo drug, Kadcyla, is already approved to treat patients with advanced HER2-positive breast cancer, researchers said.
    • “The new results show that stage 1 breast cancer patients who received Kadcyla stayed free of invasive cancer five years after treatment.
    • “One year of [Kadcyla] after surgery for patients with a stage 1 HER2-positive cancer leads to outstanding long-term outcomes, making it a reasonable treatment approach for select patients,” said senior study author Dr. Sara Tolaney, chief of breast oncology at Dana-Farber Cancer Institute in Boston.”
  • and
    • “Just 25% of people battling opioid use disorder are getting medications aimed at helping them quit and potentially avoid an overdose, new data shows.
    • “Boosting access to proper treatment might save countless lives.
    • “In 2022, 81,806 opioid-involved overdose deaths were reported in the United States, more than in any previous year,” noted a team led by Deborah Dowell, chief medical officer at the U.S. Centers for Disease Control and Prevention’s Division of Overdose Prevention.
    • “Dowell and her colleagues looked at data collected for 2022 as part of the National Survey on Drug Use and Health. The survey involved almost 57,000 adults.”
  • The National Institutes of Health adds,
    • “Results from a national survey indicate that many Americans, 61%, are unaware that primary care physicians can prescribe medications for opioid use disorder, and 13% incorrectly believed that they could not. The survey, funded by the National Institutes of Health (NIH), also found that 82% of the people who reported ever misusing prescription or illicit opioids expressed comfort in going to their primary care physicians for medications for opioid use disorder. Among those who had not misused opioids, a majority, 74%, reported they would be comfortable referring their loved ones to primary care for these medications.
    • “Notably, Black American respondents were most likely to incorrectly believe they could not receive medications for opioid use disorder via primary care, pointing to an important disparity in information that may further impede access to treatment. The findings suggest there is an important opportunity to increase awareness of these treatments and how to access them – using efforts that employ culturally specific strategies to reach different groups. Decades of research have shown the overwhelming benefit of existing medications for opioid use disorder, such as buprenorphine and methadone.
    • “Primary care is often people’s first point of contact in the health care system and can serve as a crucial setting to talk about addiction and receive lifesaving medications,” said Nora D. Volkow, M.D., Director of NIH’s National Institute on Drug Abuse (NIDA). “We need to provide education and support so that patients feel empowered to seek help from their primary care physician, and their doctors feel prepared to help them.”
  • Behavioral Health Business explains why “Feeding Disorder Treatment Programs Are Urgently Needed for Children with Autism.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Optum will not bid on Steward Health Care’s physician group, Stewardship Health, during the bankrupt health system’s upcoming auction, a Massachusetts state official has confirmed.
    • “The news is a major setback for Steward, which has repeatedly identified selling Stewardship as critical for its financial stabilization. 
    • “Steward took out $150 million in loans to fund the transaction in February. Its attorneys have claimed during federal bankruptcy proceedings that the sale proceeds would be enough to cover debts to certain lenders and, as recently as June 13, the Dallas-based system tied $75 million of new debtor-in-possession financing — which funds operations during restructuring — to the successful completion of a Stewardship sale.
    • “While Steward hammered the importance of selling Stewardship, it only had one public buyer at the table: UnitedHealth-owned Optum. 
  • and
    • “Amwell is implementing a reverse stock split to avoid being kicked off the New York Stock Exchange, the telehealth vendor said Friday. 
    • “The company has struggled to reach profitability, and its stock price has declined precipitously since entering the public markets in 2020. In April, the telehealth company received a warning notice from the NYSE that its stock was trading below minimum standards, closing at less than $1 per share for 30 consecutive days. 
    • “The company’s board of directors approved a 1-for-20 reverse stock split, a maneuver that consolidates the number of existing shares of stock to boost its share price. The split will be effective at market close on July 10.”
  • MedCity News shares expert observations on recent acquisitions by Kaiser Permanente’s Risant Health subsidiary.
    • “Is Risant Health the rising star of scalable, profitable value-based care models for health systems?
    • “It’s a little early to break out the champagne and toast to the company’s success, but it might soon be time to start thinking about ordering some flute glasses should a celebration be in order.”
  • Beckers Payer Issues notes,
    • “Blue Cross and Blue Shield of Rhode Island is eliminating nearly 65% of prior authorization requirements for primary care providers by early 2025. 
    • “BCBSRI reviewed data to identify some of the most common orders that create additional work for PCPs. Radiology and cardiology services lead the list of requirements being cut, and the changes will apply across commercial and Medicare plans, according to a June 27 news release. * * *
    • “BCBSRI removed all prior authorization for outpatient behavioral services in 2018. Other payers such as UnitedHealthcare, Cigna, BCBS Michigan, Point32Health and Aetna have all reduced prior authorization requirements recently.”
  • The Employee Benefits Research Institute presents an EBRI Issue Brief titled “The Impact of Expanding Pre-Deductible Coverage in HSA-Eligible Health Plans on Medication Adherence.”
    • “IRS Notice 2019-45 allows health savings account (HSA)-eligible health plans the flexibility to cover 14 drug classes and other health services used to prevent the exacerbation of chronic conditions prior to meeting the plan deductible. In this Issue Brief, we used claims data to quantify the effect of expanding pre-deductible coverage on medication adherence among enrollees with certain chronic conditions. We found some evidence that expanding pre-deductible coverage in HSA-eligible health plans increased medication adherence in 2022, but not earlier.”

Thursday Miscellany

David Ermer–Congress, FDA, HSA, Medical / Rx research, NIH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Following up on the House Appropriations subcommittee’s approval of the Financial Services and General Government bill yesterday, Fedweek notes,
    • “By taking no position on a raise, the measure effectively endorses President Biden’s proposal for a 2 percent increase in January. That would follow the practice of most recent years of allowing the recommendation to take effect by default, and would result in the smallest raise since the 1 percent paid in January 2021. The measure however does continue longstanding language tying raises for wage grade employees to those of GS employees in an area, even though the two pay systems operate under separate locality-based rules.”
  • The Washington Post reports “Biden wants hospitals to report data on gunshot wounds.”
    • “The Biden administration is enlisting America’s doctors to help combat gun violence.
    • “About 160 health-care executives and officials have been invited to the White House today and Friday to promote public health solutions to the epidemic. A top priority, I’m told: The White House wants hospital emergency departments to collect more data about gunshot injuries their physicians treat, as well as routinely counsel patients about the safe use of firearms.”
  • Healthcare Dive informs us,
    • “A federal judge ruled Wednesday Novant Health can move forward with its plans to purchase two North Carolina hospitals from Community Health Systems, despite a request from the Federal Trade Commission to stall the deal.”A federal judge ruled Wednesday Novant Health can move forward with its plans to purchase two North Carolina hospitals from Community Health Systems, despite a request from the Federal Trade Commission to stall the deal.
    • “The antitrust agency sued to block the deal in January, claiming it would decrease competition and drive up consumer prices in the greater Lake Norman, North Carolina, area by allotting Novant more than 65% control of the region’s inpatient market.
    • “U.S. district judge Kenneth Bell denied the FTC’s request for an injunction, saying the hospitals are likely to shutter absent a deal.”
  • On a related note, the Wall Street Journal continues its series on hospital consolidation.

From the public health and medical research front,

  • The Washington Post reports
    • “A 59-year-old male resident of Mexico died after being infected with a bird flu subtype never before confirmed to have spread to humans, the World Health Organization said Wednesday.”
    • “The man, who suffered from other underlying health conditions, had no known exposure to poultry or other animals before being formally diagnosed by a laboratory with the H5N2 subtype of avian flu. The case marks the first time a human has been confirmed to be infected with this subtype, and the first time an avian H5 virus was confirmed in a person in Mexico.
    • “Due to the constantly evolving nature of influenza viruses, WHO continues to stress the importance of global surveillance,” WHO said in a statement. “This case does not change the current WHO recommendations on public health measures and surveillance of influenza,” it added, rating current risks to the general population as “low.”
  • and
    • “‘Unusual’ cancers emerged after the pandemic. Doctors ask if covid is to blame.”‘Unusual’ cancers emerged after the pandemic. Doctors ask if covid is to blame.
    • “It’s not a new idea that viruses can cause or accelerate cancer. But it will probably be years before answers emerge about covid and cancer.”
  • Mercer Consulting offers bird flu considerations for employers.
  • The NIH Director in her blog relates,
    • “The ability to communicate using only your thoughts might sound like the stuff of science fiction. But for people who don’t have the ability to speak or move due to injury or disease, there’s great hope that this may one day be possible using brain-computer interfaces (BCIs) that can “read” relevant brain signals and translate them into written or spoken words. A research team has made a preliminary advance in this direction by showing for the first time that a computerized brain implant can decode internal speech with minimal training.
    • “In the new NIH-supported study, researchers implanted such a device in a brain area known to be important for representing spoken words called the supramarginal gyrus in two people with tetraplegia, a condition marked by full body paralysis from the neck down due to cervical spinal cord injury. The researchers found that the device could decode several words the participants “spoke” only in their minds. While we are far from using such a device to decode whole sentences or even phrases, and the exact mechanisms of internal speech are still under study, the findings, reported in Nature Human Behavior , are notable because it had been unclear whether the brain signals involved in thinking words could be reproducibly translated. * * *
    • “While there is much more to learn about how to decode internal speech more reliably across individuals, the findings offer proof-of-concept for a high-performance internal speech BCI. The new research adds to a growing portfolio of rapidly advancing technologies supported by the BRAIN Initiative that could one day routinely restore the ability to communicate for those who can no longer speak or even move, including people with brain injuries, paralysis, or diseases such as amyotrophic lateral sclerosis (ALS).”
  • Per BioPharma Dive,
    • “Expert advisers to the Food and Drug Administration will need to weigh whether Eli Lilly’s experimental Alzheimer’s disease drug donanemab is widely effective or should be restricted only to people who have deposits in their brains of a toxic protein called tau, according to documents released Thursday ahead of a key regulatory meeting next week.
    • “The FDA will also ask its advisers to provide guidance on whether and when it’s safe for people to stop taking donanemab based on reductions in another toxic protein called amyloid, as well as on the risks of mild brain swelling that can result from donanemab and other drugs of its type.”The FDA will also ask its advisers to provide guidance on whether and when it’s safe for people to stop taking donanemab based on reductions in another toxic protein called amyloid, as well as on the risks of mild brain swelling that can result from donanemab and other drugs of its type.
    • “If approved, donanemab would be the third amyloid-targeted drug to launch. Biogen has withdrawn the first, called Aduhelm, after much controversy and few sales. Eisai, along with Biogen, more recently won approval of a second, called Leqembi, which brought in sales of $19 million in the first quarter.”

From the U.S. healthcare business front,

  • Health Affairs offers advice to employers about how to help employees reduce their healthcare costs.
    • “Employers, and especially small employers, may have limited ability to affect the direct causes of increasing spending—notably high prices. However, they do have some options that could lower the burden of out-of-pocket costs for their employees. Employers could partner with insurers to use more innovative cost-sharing structures in the health insurance benefits offered to their employees. In addition, they could increase the use of benefit designs that distribute costs more equitably, which may improve affordability for low- to middle-income workers.”
  • HR Dive tells us,
    • “In an era when retirement is frequently at the forefront of ageism, diversity and benefits conversations, older adults now make up a larger share of American workforce members over the age of 55. The Employee Benefit Research Institute found that adults aged 65 and older made up 29.5% of the workforce in 2023, compared to an estimated 23% in 2000.
    • “Additionally, EBRI noted that the share of Hispanic workers aged 55 and older more than doubled, with the share of older White workers dropping from about 87% to 81%.
    • “The changing demographic characteristics of the older workforce are “important considerations for employers to understand, as older workers and a more diverse work force calls for additional or new answers to the optimal design of employee benefit plans,” Craig Copeland, director of wealth benefits at EBRI, said in a release.”
  • EBRI also released a Fast Facts publication informing us that “HSAs Reduce Use of Outpatient Services and Prescription Drugs, Increase Use of Inpatient Services; Overall Spending Unaffected.”