Weekend Update

Federal employment benefits

Weekend Update

David Ermer–Congress, Federal employment benefits, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • The deadline for Congress to take action on Fiscal Year 2025 appropriations is Friday December 20.
  • FedWeek lets us know,
    • “Rep. James Comer, R-Ky., is due to remain chairman of the Oversight and Accountability Committee for the 2025-2026 Congress.” * * *
    • “On the Senate side, another Kentucky Republican, Sen. Rand Paul, is set to become chairman of the Homeland Security and Governmental Affairs when the GOP takes control of that chamber.” * * *
    • “There has been no indication of a nominee for OPM director, but one potential candidate would be Michael Rigas, who was deputy director late in the first term and then acting director from March 2020 when the second of the directors confirmed in that administration resigned after disputes over the White House’s intent to move OPM’s policy functions directly under OMB. Rigas was not then nominated to become director, however.”
  • The Medicare open enrollment period ends this Saturday December 7, while the Federal Employees Benefits Open Season is scheduled to end the following Monday, December 9. It remains to be seen whether OPM will extend the first open season for the Postal Service Health Benefits Program as some have urged.
  • The FEHBlog urges OPM and PSHBP carriers to share with Postal Service annuitants over age 65 the substance of this Washington Post article about “How to take advantage of Medicare’s expanded drug benefit in 2025. “It will be easier to spread out Part D drug costs over the year, while the total annual cost of medicines will be capped at $2,000.” The new Medicare Part D features make Part D a viable alternative to folks who currently rely on manufacturer coupons.
  • The U.S. Attorney’s Office for the Southern District of Texas announced last Wednesday,
    • “A 53-year-old Sugar Land [Texas] man has agreed to pay $2,095,946 to resolve allegations he submitted false claims for the placement of electro-acupuncture devices, announced U.S. Attorney Alamdar S. Hamdani.
    • “Dr. Rajesh Bindal used the entity Texas Spine & Neurosurgery Center P.A. to conduct his medical practice. From March 16, 2021, to April 22, 2022, Bindal billed Medicare and the Federal Employees Health Benefits Program (FEHBP) for the surgical implantation of neurostimulator electrodes. 
    • “These are invasive procedures usually requiring use of an operating room. As a result, Medicare and the FEHBP pay thousands of dollars per procedure. 
    • “However, neither Bindal nor his staff performed these surgical procedures, according to the allegations. 
    • “Instead, patients allegedly received devices used for electro-acupuncture, which only involved inserting monofilament wire a few millimeters into patients’ ears and taping the device behind the ear with an adhesive. In some instances, a device sales representative or a physician assistant allegedly performed these placements, which were then billed as surgeries. All device placements took place in Bindal’s clinic, not a hospital or surgical center, and no incision was made on a patient. Most patients claimed the adhesive came loose and the device fell off on its own accord within a few days.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Many of the manufacturing jobs that are being moved overseas, replaced by automation or phased out of the American economy were mostly filled by men. As a result, other occupations traditionally dominated by women are now gaining a larger share of men, including elementary and middle-school teachers and customer-service representatives. 
    • “Still, nursing is a relative outperformer in the proportion of men joining what has long been considered a “pink collar” sector. The number of male registered nurses has increased from about 140,000 in 2000 to about 400,000 in 2023. This means that about 14% of nurses are now men, up from about 9% roughly two decades ago. 
    • “Economists at the Washington Center for Equitable Growth found that men who were becoming registered nurses tended to do so in their late 20s or early 30s rather than as their first job.”
  • and
    • “The obesity duopoly has been pierced as Amgen positions itself to have a drug on the market in a few years. While this adds competition to a market currently controlled by Eli Lilly and Novo Nordisk, it also reinforces the dominance of the makers of Wegovy and Zepbound.
    • “Amgen reported on Tuesday that its highly anticipated obesity-drug candidate, MariTide, helped patients shed around 20% of their body weight, though side effects such as nausea and vomiting were common. The company didn’t disclose detailed data, which is expected at a medical conference next year. If all goes well in a larger late-stage study, Amgen could have a drug on the market within a few years. 
    • “But what we already know suggests that Lilly and Novo Nordisk’s market leadership isn’t about to be upended. Not only did MariTide fail to outperform Lilly’s Zepbound, but both Lilly and Novo also have next-generation medications under development, with promising data showing even more impressive weight loss results.”
  • HR Dive tells us
    • “What employers should know now that the 2024 [Fair Labor Standards Act] overtime rule is vacated.
    • “One attorney cautioned against dropping workers’ recently changed nonexempt status too quickly or without careful consideration.”

Friday Factoids

David Ermer–CDC, CMS, COVID-19, Federal employment benefits, Medical / Rx research, Medicare, NIH, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC

  • Federal News Network points out three reasons why federal and postal employees and annuitants should consider their FEHB plan options before Open Season ends on December 9.
  • FedWeek updates its Open Season FAQs for the benefit of Postal employees and annuitants.
  • The Government Accountability Office released a report comparing employer sponsored plans against Affordable Care Act marketplace plans.
    • “In 2023, about 165 million individuals in the U.S. got their health coverage through an employer and about 16 million got coverage through Affordable Care Act Marketplaces.
    • “Comparing the costs of these plans isn’t straightforward. For example, people with employer-sponsored plans pay their premiums with pre-tax dollars. People with Marketplace plans pay their premiums with after-tax dollars. Other factors (e.g., geographic area, level of coverage) can also affect costs.
    • “We estimated that people with employer-sponsored plans had lower average premiums, but their average contributions to those premiums were higher than those in Marketplace plans.”
  • Beckers Payer Issues informs us,
    • “Some insurers are sounding the alarm that Medicare coverage of weight loss drugs could increase premiums. 
    • “On Nov. 26, CMS issued its proposed rule for Medicare Advantage plans in 2026. The rule included a proposal to allow the program to pay for weight loss drugs for individuals with obesity. 
    • “The coverage would also extend to Medicaid beneficiaries. The White House estimated more than 7 million people would be eligible for weight loss drugs if coverage is expanded. 
    • Ceci Connolly, president of the Alliance of Community Health Plans, called the proposal “irresponsible, without further analysis and stakeholder engagement.” 
    • “We are deeply concerned with the proposed coverage expansion of weight-loss drugs in Medicare and Medicaid,” Ms. Connolly said. “The excessive prices drugmakers command for GLP-1s have enormous cost consequences for consumers, taxpayers and employers.” 
    • “The organization represents 30 nonprofit health plans.”
  • STAT News reports,
    • “Bristol Myers Squibb has filed a lawsuit accusing the Biden administration of unlawfully preventing the company from using rebates to pay hospitals that participate in a federal drug discount program, the fourth large pharmaceutical company to attempt a change in payment terms in recent weeks.
    • “The drugmaker sought that move for its widely prescribed Eliquis blood thinner, but the U.S. Department of Health and Human Services maintained such a switch would violate federal law. The agency recently made the same determination in rejecting moves by Johnson & Johnson and Eli Lilly to change payment terms, both of which filed lawsuits. Sanofi also wants to change payment terms but has not filed a lawsuit.
    • ‘In its lawsuit, Bristol argued that the 340B Drug Discount Program is rife with waste and abuse. The program was created three decades ago to help hospitals and clinics care for low-income and rural patients. Drug companies that want to take part in Medicare or Medicaid must offer their medicines at a discount — typically, 25% to 50%, but sometimes higher — to participating hospitals and clinics.
    • “However, Bristol had an additional motive for filing its suit. Eliquis was selected by Medicare for price negotiations. And the agency wants manufacturers to ensure the 340B discount and maximum fair price under the Inflation Reduction Act are not applied to the same drug. By offering rebates instead of discounts, the company is trying to avoid this conundrum. J&J stated the same concern in its lawsuit.”

From the public health and medical research front,

  • The Wall Street Journal tells us,
    • “More than 1 in 4 people over age 65 fall each year. Earlier this month, the veteran TV host and comedian Jay Leno was one of them. Leno, 74, left his hotel near Pittsburgh looking for a bite to eat. It would have been a long walk to the restaurant, so he took a shortcut down a grassy hill. A tumble on the slope left him with a broken wrist and significant bruises to his face and entire left side. 
    • “Leno still managed to do his comedy act that night. He was luckier than many fall victims. Every year falls among older Americans result in about 3.6 million emergency room visits and 1.2 million hospital stays, at a cost of roughly $80 billion. Nationwide, 41,000 senior citizens die from falls annually, according to the Centers for Disease Control and Prevention. In recent years, prominent figures such as comedian Bob Saget, former Connecticut Sen. Joe Lieberman and Ivana Trump died after a fall.
    • “And despite progress in care and prevention techniques, a University of Michigan study found that the number of falls goes up about 1.5% every year. “It could be that efforts aren’t working—or that they are, by mitigating even worse potential injury risk in the population,” said Geoffrey Hoffman, a gerontologist at the University of Michigan. “Either way, more investment in prevention and funding for fall education and prevention programs would help.” 
    • “The CDC operates a program known as STEADI (Stopping Elderly Accidents, Deaths and Injuries) to assist healthcare providers in screening older patients for fall risk factors, such as a history of falls, vision problems, inadequate vitamin D intake and foot problems. In one common test, the patient must get up from a chair, walk 10 feet, turn around, walk back and sit down. If this takes more than 12 seconds, they are deemed to be at risk for a fall.
    • “Earlier this year, Rep. Carol Miller of West Virginia, a Republican, introduced legislation to make fall-risk assessment part of Medicare’s annual wellness benefit for all seniors. The bill, known as the SAFE Act, would also direct the Department of Health and Human Services to report annual statistics about falls to Congress.”
  • Medscape discusses new data supporting the most promising treatments for long Covid.
  • Per an NIH press release,
    • “Children of mothers who took certain antiseizure medications while pregnant do not have worse neurodevelopmental outcomes at age 6, according to a long-running study funded by the National Institutes of Health (NIH). The study was published in JAMA Neurology.
    • “Controlling seizures during pregnancy is an important part of prenatal care for women with epilepsy, but for years, the effects of newer antiseizure medications on their children was unknown,” said Adam Hartman, M.D., program director at NIH’s National Institute of Neurological Disorders and Stroke (NINDS). “One major component of this study was correlating the cognitive abilities of children with maternal blood levels of the drugs. This opens the door to future work and might inform better dosing strategies.”
    • “Treating epilepsy during pregnancy is challenging, as some antiseizure medications, primarily older drugs such as valproate, are known to cause serious birth defects and cognitive problems in children, including lower IQ and autism spectrum disorders. Newer antiseizure drugs that are widely used today are generally considered safe, but little is known about whether they affect cognition in children after fetal exposure.”
  • The Washington Post reports,
    • “A farm that supplies organic, pasture-raised eggs for Costco has issued a recall for more than 10,000 products sent to 25 retail locations in five southern states.
    • “Handsome Brook Farms said the eggs, which were sold in packs of 24 under the label of Kirkland Signature, could be contaminated with salmonella. The recalled eggs were sent to Costco stores in Alabama, Georgia, North Carolina, South Carolina and Tennessee, the farm said. The affected products were sent beginning Nov. 22 and bear the UPC 9661910680, along with the code 327 and a “use by” date of Jan. 5, 2025, printed on the side.
    • “Handsome Brook Farms, which is working with the Food and Drug Administration on the recall, said no one has reported being sickened by the eggs. Salmonella is a bacteria that can cause diarrhea, fever and abdominal cramps, according to the FDA. More severe cases can be fatal, and children, elderly people and those with weakened immune systems are more vulnerable to more acute infections.”
  • NBC News adds,
    • “An Arizona produce company is recalling all sizes of its whole, fresh American cucumbers in 26 states and parts of Canada because they could be contaminated with salmonella, it said.
    • “SunFed said in an announcement posted online Thursday by the Food and Drug Administration that cucumbers it sold from Oct. 12 to Nov. 26 were recalled because of the potential contamination, which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems.
    • “The recalled cucumbers were packaged in bulk cardboard containers marked with the SunFed label or in generic white boxes or black plastic crates with stickers naming the grower, according to the company.
    • “The produce was distributed in 26 states: Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Kansas, Maryland, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin.”
  • The CDC notes that “Due to the Thanksgiving holiday, the weekly respiratory virus data and summaries will not update on Friday, November 29, 2024. Data updates will resume on Monday, December 2, 2024.”  Lo siento.

From the U.S. healthcare business front,

  • Health Affairs Scholar lets us know,
    • As policymakers continue to grapple with rising health care costs and prices, understanding trends and variations in inpatient prices among hospital characteristics is an important benchmark to allow policymakers to craft targeted policies. In this study, we provide descriptive trends on variation in inpatient prices paid by commercial health plans stratified by hospital characteristics using data from Health Care Cost Institute’s employer-sponsored insured claims data.
    • Our analyses found evidence of considerable variation among inpatient price levels and growth among system affiliation and profitability. Prices among system-affiliated hospitals grew from $14,281.74 in 2012 to $20,731.95 in 2021, corresponding to a 45.2% increase during this period. On the other hand, prices among independent hospitals grew more slowly, from $13,460.50 in 2012 to $18,196.90 in 2021, corresponding to a 35.2% increase.
    • We did not observe a similar trend in growth rates among case mix index by hospital characteristics, implying that differential inpatient price growth is not driven by changes in case mix by hospital characteristics. Heterogeneity in hospital prices and price growth by type of hospital suggests that public and private policymakers aiming to rein in health spending should consider policies that address this variation.
  • Per BioPharma Dive
    • “For drug companies, predicting how much money a product will make is a risky endeavor. If the estimate ends up being far off, then investors may question how well a developer understands its own business or the markets in which it operates. That’s especially true when the prediction is too high.
    • “Analysts on Wall Street were therefore surprised last month to hear Intra-Cellular Therapies, which never much entertained this guessing game, say that its brain-rebalancing drug Caplyta would reach $5 billion in annual sales sometime in the next decade. This year alone, the New Jersey-based company expects $665 million to $685 million in net product sales from Caplyta. * * *
    • “Known scientifically as lumateperone, Caplyta is already approved to treat schizophrenia and bipolar depression and could be cleared for major depressive disorder as early as next year. Intra-Cellular licensedthe drug from Bristol Myers Squibb in 2005, just a few years after the company formed and right as big pharma really started backing away from neuroscience and psychiatry. Now, the company has about 530 sales reps and plans to expand again in preparation for the move into major depression.”
    • In the article, BioPharma Dive interviews Sharon Mates, Intra-Cellular’s founder and CEO.
  • Modern Healthcare reports,
    • “Tim Barry, the CEO of VillageMD, has left the company following a rocky few years mired by its failure to help execute on a healthcare push launched by majority-owner Walgreens Boots Alliance.
    • “It’s unclear exactly when Barry left the Chicago-based company, but VillageMD Chief Operations Officer Jim Murray replaced him “effective immediately,” assuming all day-to-day leadership responsibilities, spokeswoman Molly Lynch said in a statement to Crain’s today.
    • “VillageMD reaffirms its commitment to providing high-quality, accessible healthcare services for individuals and communities across the United States,” Lynch said. She declined to provide additional information about the transition.
    • “Barry co-founded VillageMD in 2013 as a primary care company focused on value-based care, growing to hundreds of locations across the country.”

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.”

Midweek Update

David Ermer–AHRQ, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, OPM, U.S. Healthcare, Uncategorized–
Photo by Tomasz Filipek on Unsplash

From Washington, DC

  • This afternoon the FEHBlog was listening to an OPM meeting about the PSHBP when someone mentioned a benefit administration letter. The FEHBlog realized that he was overdue in posting the 2025 FEHB and PSHBP Significant Plan Changes notices which appear under on OPM’s benefit administration letters page.
  • Kevin Moss, writing in Govexec, pitches the many advantages available to annuitants over age 65 who enroll in an FEHB or PSHB plan’s Medicare Part D EGWP for 2025. Mr. Moss warns readers about the income adjusted Part D premiums (IRMAA) and the Medicare bar against using manufacturer coupons. In the FEHBlog’s opinion, the combination of the Medicare Part D’s new features for 2025 — a $2000 out of pocket maximum and the Medicare Prescription Payment Plan — outclass manufacturer coupons and diminish the impact of IRMAA which in any case is much lower for Part D compared to Part B.
  • HUB International reminds us,
    • “Back in 2020, the Coronavirus Aid, Relief, and Economic Security (CARES) Act first allowed HDHPs to cover telehealth and other remote care services on a first dollar basis through the end of 2021. This was initially designed to make medical care accessible during the COVID-19 pandemic, when it may not have been for many in need.
    • “Congress first resurrected this relief in April 2022 after a three-month hiatus. This relief was scheduled to end on December 31, 2022, until Congress extended it once again. This second extension is now coming to an end for plan years beginning on or after January 1, 2025.”
  • The lame duck session of Congress could pass a law extending this benefit beyond 2024.
  • The U.S. Preventive Services Taskforce presented its 14th annual report to Congress on “High-Priority Evidence Gaps Across the Lifespan, in All Communities” today.

From the public health and medical research front,

  • MedPage Today tells us,
    • “Among adults with outpatient respiratory syncytial virus (RSV) infections across six RSV seasons, roughly one in 20 were hospitalized within 28 days, according to a large cohort study that used data from three health record databases.
    • “In the cohort of over 67,000 patients with outpatient medically attended RSV infections, hospitalization rates were 4.5% to 6.2%, and 6.5% to 8.5% in a high-risk subgroup, across the three databases, reported Joshua T. Swan, PharmD, MPH, of Pfizer in New York City, and colleagues in JAMA Network Open.
    • “High-risk features included age 65 and older, asthma, chronic obstructive pulmonary disease (COPD), and congestive heart failure (CHF). Across the patients in the three databases, comorbidity prevalence were 20% to 30.5% for COPD, 14.6% to 24.4% for CHF, 14.6% to 24.4% for asthma, and 14% to 54.5% for age 65 and over.
    • “Infection rates for RSV have been underestimated, partly due to underutilization of testing for the viruses, Swan and team noted. Although there are three available vaccines against RSV, there are few approved treatments for it.”
  • and
    • “Diagnoses of postpartum depression (PPD) increased significantly across all racial and ethnic groups and prepregnancy body mass index (BMI) categories over the past decade, according to a California-based cross-sectional study.
    • “An analysis of more than 400,000 pregnancies found that prevalence of PPD doubled from 2010 to 2021 (9.4% vs 19%), according to Darios Getahun, MD, PhD, MPH, of Kaiser Permanente Southern California in Pasadena, and co-authors.
    • “While rates increased across all groups, the largest increases were seen in those who identified as Asian and Pacific Islander (280% increase) and non-Hispanic Black (140% increase), they reported in JAMA Network Open.”
  • The National Cancer Institute released cancer information highlights about “B-Cell Lymphoma | Advanced Cancer | Skin Cancer and Darker Skin.”
  • Per Fierce Pharma,
    • “It was only last October that UCB’s up-and-coming immunology powerhouse Bimzelx first crossed the FDA finish line in psoriasis after an initial delay. Now with a new nod in hidradenitis suppurativa (HS), the drug seems to be carving the path to blockbuster land with five approved indications.
    • “Bimzelx, which is the first to selectively inhibit IL-17F as well as IL-17A, was cleared to treat adults with moderate to severe forms of the disease after proving it could help patients significantly reduce signs and symptoms of the condition. HS is characterized by chronic and recurring painful nodules, abscesses and pus-discharging fistulas that can have a major impact on quality of life.
    • “UCB is “thrilled” with the milestone, head of patient impact and chief commercial officer Emmanuel Caeymaex said in a company press release.”

From the U.S. healthcare business front,

  • Fierce Healthcare informs us,
    • “More than half of health system and health plan executives say AI is an immediate priority, and 73% are increasing their investments in the technology, a new C-suite survey finds.
    • “Many healthcare organizations are moving past early pilot successes to enterprise scaled solutions, but are balancing AI enthusiasm against pragmatism, according to the survey from Define Ventures of C-suite and senior executive leaders from more than 60 providers and payers.
    • “Define Ventures, a venture capital firm focused on early-stage health tech companies, conducted surveys and meetings with executives from 10 of the top 20 providers and three of the top 10 payers to check the industry’s pulse on AI adoption and investment. The survey took place from August through early November.”
  • Per BioPharma Dive,
    • “Pfizer on Wednesday said it will promote Chris Boshoff to chief scientific officer and president of research and development as the giant drugmaker struggles to win back the faith of investors.
    • “Boshoff will assume his new post on Jan. 1, succeeding Mikael Dolsten, who oversaw research at Pfizer for 15 years. The company announced Dolsten’s departure in July.
    • “Boshoff currently serves as chief oncology officer and is credited with delivering 24 approved new medicines and biosimilars during his 11-year tenure at the company. Boshoff has also worked as Pfizer’s head of development in Japan and as chief development officer for oncology and rare disease.”
  • Kauffman Hall discusses the misadventures of primary care.
  • Modern Healthcare reports,
    • “Three lawsuits filed against data analytics firm MultiPlan alleging antitrust law violations for reducing pay for out-of-network providers have been consolidated into one suit seeking class action status.
    • “The American Medical Association and the Illinois State Medical Society filed suit against the company in October in federal court in Illinois. Advanced Orthopedic Center, a medical practice in Poway, California filed its suit in June in federal court in New York. Orthopedic provider Dr. Curtis Robinson filed his suit in federal court in California.
    • “The complaints, all now in the U.S. District Court for the Northern District of Illinois, allege MultiPlan has contracts with 700 large insurers, which allows them to have unfair control of market rates for provider pay.” * * *
    • “A spokesperson for MultiPlan said the company intends to fight the allegations.

Tuesday Tidbits

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

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.”

Weekend Update

David Ermer–CDC, Congress, Federal employment benefits, OPM, U.S. Healthcare–

From Washington, DC

  • Decision Desk puts 2024 House election results at 220 Republicans to 213 Democrats while the AP count is 2018 Republicans to 212 Democrats. The total number of Representatives is 435, and a majority is 218 members.
  • Per Modern Healthcare,
    • “The Drug Enforcement Administration is set to once again extend a COVID-19 era rule that allows clinicians to remotely prescribe controlled medications, such as Adderall and Vicodin. 
    • “The DEA is set to publish a rule on Tuesday with the Health and Human Services Department that will temporarily extend providers’ ability to remotely prescribe Schedule II-V controlled medications via telemedicine to new and existing patients through Dec. 31, 2025. Current flexibilities were set to expire at the end of this year.”
    • “On Friday, an unpublished version of the rule was released on the Federal Register.” 
  • The Wall Street Journal offers an informative report on the federal civilian workforce.
    • “There are 2.3 million Americans working for the federal government in civilian jobs, a tally that has steadily climbed as control of the White House has shifted between parties and presidents. 
    • “They constitute less than 2% of the total U.S. workforce. They work as everything from nurses in Veterans Affairs hospitals and park rangers in Yellowstone to guards in federal prisons and the 19 employees of the Nuclear Waste Technical Review Board. About 80% of them work outside of the Washington, D.C., region.” * * *
    • “Roughly 70% of the civilian roles are in military- or security-related agencies. Veterans Affairs has the most civilian workers, mainly because it operates hundreds of hospitals and clinics. Homeland Security, created in 2002, is now the third largest. The Education Department, with 4,425 workers, is the smallest.”
  • Stars and Stripes updates us on the pilot program to improve access to healthcare for federal employees living and working in Japan. There are 11,000 federal employees living and working in Japan. The FEHBlog understands that the access problem occurs outside the Tokyo metropolitan area.
  • Per Legal Dive,
    • [Martine] Cicconi, a former special counsel in the Office of the White House Counsel, expects a “dynamic” regulatory environment over the next year. Following Trump’s election, she said the primary question she hears from corporate clients regards the fate of regulatory rules under Biden that remain in various stages of implementation.
    • These regulations tend to fall into four categories, Cicconi said.
      • Rules under consideration, not yet finalized. These will probably be subject to a regulatory pause by the incoming administration on Jan. 20.
      • Rules that are passed before Biden’s term ends, and within the past 60 days will be subject to the Congressional Review Act, Cicconi said. The next Congress, under Republican control in January, is likely to enjoin Biden rules with a joint resolution Trump would sign. 
      • Finalized agency rules that are still wending their way through litigation, including some that have been enjoined. The Trump administration is likely to stop defending many of the Biden rules, which would effectively end them. However, “in many of those challenges there are intervenors with authority to defend the rule going forward,” Cicconi noted.
      • That means rules that have survived court challenges and avoided being enjoined “will stay at least on the books” pending further administration action, she said.

From the public health and medical research front,

  • The New York Times reports,
    • “A person in California has tested positive for a form of mpox causing a widespread epidemic in Africa, the state’s Department of Public Health reported on Saturday. It is the first known case in the United States.
    • “The individual, who was not identified, had recently returned from East Africa. The patient was diagnosed in San Mateo County, just south of San Francisco, and was isolating at home.
    • “Officials at the California Department of Public Health and at the Centers for Disease Control and Prevention are reaching out to potential contacts of the patient for further testing.
    • “There is no evidence that this version of the mpox virus, called Clade Ib, is circulating in communities in the United States, C.D.C. officials said.”
  • and
    • “One person has died and 39 people have become ill in an E. coli outbreak linked to organic carrots, federal regulators said on Sunday.
    • “The infections were tied to multiple brands of recalled organic whole bagged carrots and baby carrots sold by Grimmway Farms, the U.S. Centers for Disease Control and Prevention said. Fifteen people have been hospitalized, according to the agency.
    • “Carrots currently on store shelves are unlikely to be affected by the recall but those in consumers’ refrigerators or freezers may be, the authorities said.
    • “If you have any recalled carrots in your home, throw them out or return them to the store,” the C.D.C. said.” * * *
    • “The carrots were sold under multiple brand names and at several retailers, including Trader Joe’s and Wegmans.
    • “The states with the most outbreaks were Minnesota, New York and Washington, according to the Food and Drug Administration.”
  • The Washington Post lets us know,
    • “Up to 10,000 lives could be saved each year by improving access to blood in the field, a group of surgeons said in a news conference last month.
    • “The event, which took place at an American College of Surgeons clinical conference in San Francisco, emphasized how faster access to blood could improve survival during emergencies.
    • “Despite evidence that carrying blood in the field can reduce deaths by preventing patients from bleeding to death, the surgeons said, blood is rarely available to emergency responders.
    • “The bad news is that only about 1 percent of [emergency medical services] vehicles, whether it’s ground or air, carry blood in the United States,” said John B. Holcomb, a trauma surgeon and professor at the University of Alabama at Birmingham. “About 10,000 lives a year could be saved if every ambulance in the United States had blood.”
  • NPR Shots informs us,
    • “A study of cells from 84 cadaver brains suggests that Alzheimer’s has two distinct phases, and that one type of neuron is especially vulnerable.
    • “There’s an early phase where there’s a very slow increase in the amount of pathology,” says Ed Lein, a senior investigator at the Allen Institute for Brain Science in Seattle, “then a more exponential phase where suddenly things get really bad.”
    • “The study also found evidence that a small subset of neurons known as somatostatin inhibitory neurons begin to die off during the early phase of Alzheimer’s, Lein and a team of nearly 100 other scientists report in the journal Nature Neuroscience.
    • “That was quite a surprise,” Lein says, because these neurons have received relatively little attention from Alzheimer’s researchers.
    • “The findings suggest that Alzheimer’s treatments are most likely to help early in the disease, and that one strategy might be to protect vulnerable inhibitory neurons.
    • “The results also show how scientists’ understanding of Alzheimer’s is being changed by new tools and techniques that can reveal detailed information about millions of individual brain cells.
    • “They’ve produced a picture of what’s going on that no one could have anticipated just a few years ago,” says Dr. Richard Hodes, who directs the National Institute on Aging, which played a key role in funding the research.”
  • Per Fortune Well,
    • “Everyone has a different relationship with exercise. You might be a fitness junkie, hitting the gym five days a week or training for a marathon to push your body’s limits. But for most Americans, physical activity takes a backseat to everything else going on in life. 
    • “Only 26% of men, 19% of women, and 20% of adolescents get enough activity to meet aerobic and muscle-strengthening guidelines, according to the Department of Health and Human Services. 
    • “If you’re one of the many people currently not hitting the minimum exercise recommendations—150 to 300 minutes of moderate-intensity physical activity a week—then you might be missing out on substantial gains in longevity and healthspan, according to a new study published in the British Journal of Sports Medicine.”

From the U.S. healthcare business front,

  • HR Dive tells us,
    • “A Texas federal judge on Friday struck down the U.S. Department of Labor’s recently expanded overtime rule nationwide, stripping overtime eligibility from an estimated 1 million workers, according to a court filing. 
    • “U.S. District Court Judge Sean Jordan ruled that “the 2024 Rule exceeds the Department’s authority and is unlawful.” The ruling vacates DOL’s overtime rule that changed the threshold at which workers qualified for overtime from $35,568 to $43,888 effective July 1 and would have raised it to $58,656 on Jan. 1, 2025, according to Littler attorneys.
    • “Jordan previously granted a preliminary injunction to the Texas state government days before the rule was to go into effect.”
  • Per Yahoo Finance, Optum has launched a website to present its defense against a federal antitrust lawsuit challenging an acquisition of Amedisys, a large home healthcare company. “The website notes that the home healthcare industry remains highly fragmented despite the growing market.”
  • The Wall Street Journal reports that “Makers of Ozempic, Zepbound fight to stop compounded copies of their drugs {when it is} unclear whether pharmaceutical companies can increase production enough.

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–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Washington Post reports,
    • “Republican lawmakers returned to Capitol Hill on Tuesday with some spring in their step.
    • After winning the presidency and the Senate majority, the party is on the cusp of regaining the House majority — and with it, a powerful governing trifecta in Washington.
    • “Though control of the House may not be called for days, GOP lawmakers will this week work on the assumption they’ve clinched it, pushing ahead with House leadership elections and shaping plans to reverse or overhaul much of the Biden administration’s domestic and foreign policy.
    • “Though control of the House may not be called for days, GOP lawmakers will this week work on the assumption they’ve clinched it, pushing ahead with House leadership elections and shaping plans to reverse or overhaul much of the Biden administration’s domestic and foreign policy.”
  • The Post must be tracking the AP results (214 – 206) because Decision Desk HQ has decided that the Republicans do have a majority of seats in the House (219 – 210, 218 being a majority).
  • The Wall Street Journal reports,
    • “President-elect Donald Trump picked Tesla CEO Elon Musk and biotech company founder Vivek Ramaswamy, a former Republican presidential candidate, to lead an effort to cut spending, eliminate regulations and restructure federal agencies.
    • “Trump said in a statement Tuesday night that Ramaswamy and Musk—the wealthiest person in the world, who oversees six companies including Tesla—would lead what the president-elect called the Department of Government Efficiency, or DOGE. The department’s mandate is to streamline government bureaucracy, the president-elect said.
    • “DOGE will operate outside of the federal government, Trump said, and will work with the White House Office of Management and Budget to implement its recommendations.” 
  • The American Hospital Association News lets us know,
    • “In comments Nov. 12 to majority and minority leaders of the House and Senate, the AHA requested that Congress act on key priorities for hospitals and health systems before the end of 2024. AHA urged Congress to continue providing relief from Medicaid Disproportionate Share Hospital Payment cuts; continue the Medicare-dependent Hospitals and Low-volume Adjustment programs that expire Dec. 31; reject site-neutral payment proposals; and pass the Improving Seniors’ Timely Access to Care Act (H.R. 8702/ S. 4532), legislation that would reduce the wide variation in prior authorization methods in the Medicare Advantage program.” * * * 
    • “AHA also urged Congress to extend the hospital-at-home waiver for five years through 2029; mitigate scheduled physician reimbursement cuts for 2025; and pass the Safety from Violence for Healthcare Employees Act (H.R. 2584/S. 2768), legislation that would provide federal protections from workplace violence for hospital workers, similar to protections for airport and airline workers.”
  • and
    • “The Centers for Medicare & Medicaid Services Nov. 12 released a report evaluating past and present approaches to rural health. It shares how previous CMS Innovation Center models focusing on rural health have been applied to recent model development. 
    • “The report also shares themes, concepts and next steps gathered from its rural health “Hackathon,” a series of events across the U.S. that brought experts together to brainstorm solutions to rural health challenges. The top themes highlighted a need for training, regulatory changes and collaboration to help improve access to care and support transformation. The report also outlines possible considerations for future Accountable Care Organization-focused and other models.
    • “CMS’ next intention is to issue a request for application to fill the 10 open spaces for its Rural Community Hospital Demonstration. The program was directed by Congress and requires a test of cost-based payment for Medicare inpatient services for rural hospitals with fewer than 51 beds that are ineligible for critical access hospital status.”
  • OPM issued a press release today about the ongoing Open Season while Govexec informs us,
    • “Retired and active federal employees find selecting a health care plan to be more confusing than creating a will, reading Shakespeare, learning a new language or navigating a divorce, according to a new survey from the National Active and Retired Federal Employees Association. 
    • “While the process may be complex, NARFE is urging current and former federal and postal employees to look at their options for health care insurance carriers and coverage plans during this year’s open season, which lasts from Nov. 11 through Dec. 9, especially in light of premium price increases next year that will be the largest in recent memory. 
    • “John Hatton, NARFE’s staff vice president of policy and programs, told Government Executive that enrollees could be missing out on thousands of dollars in savings. 
    • “We always recommend people to take a look at their options during open season to make sure they have the coverage that they need so they’re not paying more in out-of-pocket expenses later, but also to pay less in premiums if they don’t need the coverage that they currently have,” he said. 
    • “More than half of active federal employees (57%) and retired ones (55%) in NARFE’s survey annually review their health insurance options. For this year’s open season, 60% of current feds responded that they are planning on participating compared to 47% of retirees.” 
  • RAND shares survey results about U.S. veterans’ families, which should be of interest to FEHB carriers as the federal government wisely hire a lot of veterans.
  • Meanwhile, AHIP fact checks a Wall Street Journal article criticizing the Medicare Advantage program.
  • The New York Times reports,
    • “The Justice Department and four Democratic state attorneys general on Tuesday filed an antitrust lawsuit against the giant UnitedHealth Group in an attempt to block its $3.3 billion deal to take over Amedisys, a large home health company.
    • “Unless this $3.3 billion transaction is stopped, UnitedHealth Group will further extend its grip to home health and hospice care, threatening seniors, their families and nurses,” Jonathan Kanter, the assistant attorney general who heads the department’s antitrust division, said in a statement on Tuesday.“
  • The Wall Street Journal adds,
    • “Johnson & Johnson launched a legal challenge against a federal health agency blocking the company’s quest to tighten the way it provides lucrative drug discounts to hospitals.
    • “J&J filed a lawsuit in federal court in Washington on Tuesday against the heads of the U.S. Department of Health and Human Services and one of its agencies, seeking a court ruling that says J&J’s plan is legal and to prevent the agency from rejecting it.
    • “The lawsuit escalates the pharmaceutical industry’s fight to rein in the federal drug-discount program known as 340B. The program, created in 1992, requires drugmakers to provide steep discounts on outpatient drugs to hospitals and clinics that serve uninsured and low-income patients. 
    • “The pharmaceutical industry has argued that the 340B program has strayed from its original purpose of helping safety-net hospitals. Manufacturers say they sell medicines to covered hospitals at steep discounts, but some large hospitals mark up the prices charged to both uninsured patients and insurers.”

From the public health and medical research front,

  • The New York Times reports,
    • “After decades of unrelenting increases, rates of sexually transmitted infections in the United States are showing hints of a downturn.
    • “Diagnoses of gonorrhea dipped in nearly all age groups last year, compared with 2022, and new cases of syphilis and chlamydia remained about the same, according to data released on Tuesday by the Centers for Disease Control and Prevention.
    • “The results are not yet cause for celebration.
    • “Overall, more than 2.4 million new S.T.I.s were diagnosed last year, about a million more than the figure 20 years ago. Nearly 4,000 babies were diagnosed with congenital syphilis last year, and 279 of them were stillborn or died soon after.
    • “Still, experts said they were cautiously optimistic that a resurgent tide of infections was beginning to turn.”
  • Per a National Institutes of Health press release,
    • “Researchers at the National Institutes of Health (NIH) and their collaborators have discovered a new way in which RAS genes, which are commonly mutated in cancer, may drive tumor growth beyond their well-known role in signaling at the cell surface. Mutant RAS, they found, helps to kick off a series of events involving the transport of specific nuclear proteins that lead to uncontrolled tumor growth, according to a study published Nov. 11, 2024, in Nature Cancer.
    • “RAS genes are the second most frequently mutated genes in cancer, and mutant RAS proteins are key drivers of some of the deadliest cancers, including nearly all pancreatic cancers, half of colorectal cancers, and one-third of lung cancers. Decades of research have shown that mutant RAS proteins promote the development and growth of tumors by activating specific proteins at the cell surface, creating a constant stream of signals telling cells to grow.” * * *
    • “The study also found evidence that mutant RAS proteins perform this same function in other cancer types, suggesting that this mechanism may be a general feature of cancers with mutated RAS genes.
    • “The researchers believe their finding may have potential applications for the treatment of RAS-fueled cancers. They have started to look at how this function for RAS works in pancreatic cancer in particular because there are so few effective treatments for this type of cancer.
    • “New treatment combinations could one day be developed that take this new role for RAS into consideration,” Dr. [Douglas] Lowy said.”
  • Health Day tells us,
    • “Lives lost to obesity-related heart disease have nearly tripled over the past twenty years, a new study reports.
    • “Heart disease deaths linked to obesity increased 2.8-fold between 1999 and 2020, according to findings presented today at the American Heart Association’s annual meeting in Chicago.
    • “The increase occurred especially among middle-aged men, Black adults, Midwesterners and rural residents, researchers found.
    • “Obesity is a serious risk factor for ischemic heart disease, and this risk is going up at an alarming rate along with the increasing prevalence of obesity,” lead researcher Dr. Aleenah Mohsin, a post-doctoral research fellow at Brown University in Providence, R.I., said in a news release.” * * *
    • “The National Institute of Health has more on the health risks of obesity.”

From the U.S. healthcare business front,

  • Fierce Healthcare surveys the major payors’ third quarter financial results as the curtain falls on the third quarter announcement season.
  • Kaufmann Hall relates,
    • “Though most indicators were down, hospital performance remained relatively stable overall, according to September data. Both inpatient revenue and average lengths of stay increased.
    • “The recent issue of the National Hospital Flash Report covers these and other key performance metrics.”
  • and
    • “In the third quarter of this year, the median investment/subsidy per physician was $304,312—rising above $300,000 for the first time. Other expense metrics such as the total direct expense per provider FTE and labor as a percentage of total expenses increased.
    • “The Physician Flash Report features the most up-to-date industry trends drawn from the same data physician groups use to track their finances and operations.”
  • Per Modern Healthcare,
    • “Ochsner Health may expand its hospital-at-home program throughout the entire health system after successfully piloting a program in New Orleans, the nonprofit healthcare provider said Tuesday.
    • “Ochsner Health said in a news release the pilot, launched in March at Ochsner Medical Center-New Orleans, prevented either initial hospitalizations or 15-day hospital readmissions for 92% of the patients referred to the program through its emergency department and observation unit.
    • “The New Orleans-based health system offered the service through a partnership with myLaurel, a New York-based company that provides transitional and acute care to frail, elderly patients at home instead of a hospital. Patients received virtual and in-home visits from clinicians, along with lab work, medications, education about treatment plans and other services.”
  • and
    • “Cardinal Health has entered definitive agreements to acquire a majority stake in GI Alliance, a gastroenterology management services organization, and the entirety of Advanced Diabetes Supply Group, a diabetes medical equipment supplier. 
    • “Cardinal expects to acquire Advanced Diabetes Supply for an estimated $1.1 billion and 71% ownership of GI Alliance for an estimated $2.8 billion. Both deals are expected to close by early 2025, pending regulatory approvals.” 
  • STAT News relates
    • “23andMe, the genetics startup that has repeatedly captured the public imagination and then faced nearly fatal business challenges, announced Monday that it would halt its efforts to develop new medicines and lay off 40% of its workforce, focusing instead on selling genetic tests to consumers and using the resulting data for research.
    • “In closing its therapeutics division and laying off 200 people, 23andMe ended an audacious bet it made nearly a decade ago — that it could use the genetic data it had collected not only to assist drug companies but to become one itself.”
  • Per Healthcare Dive,
    • “General Catalyst released new details on its planned acquisition of Akron, Ohio-based Summa Health on Thursday, roughly one year after the venture capital firm said it was looking to buy a health system. 
    • “General Catalyst’s Health Assurance Transformation business, or HATCo, has signed a definitive agreement to purchase Summa for $485 million. The deal, alongside the health system’s current cash on hand, allows Summa to eliminate $850 million in debt — nearly all the debt the health system currently holds, according to Summa’s most recent financial results.
    • “HATCo is also pledging to spend $350 million over the first five years of its ownership to support routine operations and technology investments, plus another $200 million over seven years for “strategic and transformative” initiatives.” 
  • Per MedTech Dive,
    • “Johnson & Johnson said Tuesday it received an investigational device exemption (IDE) from the Food and Drug Administration to start a U.S. clinical trial for its Ottava surgical robot.
    • “The company said it will now prepare U.S. sites to receive Ottava systems, enroll patients and begin surgical cases as it focuses on training clinical trial investigators. J&J’s soft tissue robot will compete with Intuitive Surgical’s da Vinci system, which currently leads the market.
    • “The Ottava platform will incorporate J&J Ethicon surgical instruments designed for the robotic platform, the company said. Ottava will also have a digital system called Polyphonic that will connect surgical technologies, robotics and software, ultimately adding data and insights to support clinical decision making.”
  • and
    • “GE Healthcare has struck a deal to combine its Senographe Pristina mammography system with Radnet’s artificial intelligence-based Smartmammo workflow, the companies said Monday.
    • “The alliance positions GE to distribute Radnet software designed to help mammography centers view images, prioritize cases and support other steps in the workflow. The integration is the first part of a broader collaboration focused on imaging AI.
    • “Radnet CEO Howard Berger told analysts on an earnings call Monday that the mammogram systems “simply need a power source and a connection to the internet,” creating opportunities to image patients in “Walmart and mall locations.”

Weekend Update

David Ermer–CMS, Congress, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • Congress returns from the campaign trail on Tuesday to begin its lame duck session. Here is a link to this week’s Congressional Committee schedule. The continuing resolution funding the federal government expires on December 20, 2024.
  • The Federal Employee Benefits Open Season begins at 12:01 am ET Monday morning.
  • Here is a link to an Open Season advice column written by Ann Werts in FedSmith. Ms. Werts makes an interesting observation:
    • “Once you’ve determined what you’re going to compare in the plans you’re considering, there are a couple of great tools you can use to assist you. [Checkbook’s] guidetohealthplans.org is a 3rd party resource that enters the outline of coverage for every federal health plan each year. For a small subscription fee ($15.95), you can access their website to compare any set of plans. Some agencies pay for their employees to use it, so check first to see if it’s available directly through your agency. If not, you can use the code GUIDE20 to receive a 20% discount. 
    • “OPM also provides an online comparison tool. I find it more challenging to use because the output is a 17-column spreadsheet.” 
  • As Leonardo DaVinci observed, “Simplicity is the ultimate sophistication.” 
  • OPM has created an internet portal for Postal Service Health Benefit Plan enrollees to use to compare plans and select a plan. Every PSHBP enrollee should have received a letter about this process. The OPM website explains
    • “Thank you for your interest in the Postal Service Health Benefits Program!
    • “Open Season begins on November 11. To get coverage, please visit
    • “https://health-benefits.opm.gov. You can also call the PSHB Helpline at 844-451-1261.
    • “If you have technical issues with your Login.gov account, Login.gov operates a 24/7 contact center via phone or website contact form. Please visit login.gov/contact for more information.”
  • For those unfamiliar with login,gov, it’s an identity verification tool that the federal government uses with all Americans, not just PSHBP enrollees, to access IRS and Social Security portals as well as the PSHBP enrollment portal.
  • Here is a link to OPM’s public use files for FEHBP, PSHBP, and FEDVIP.
  • Kiplinger offers a better 2025 Medicare Parts B and D IRMAA chart compared to the ones in Friday’s CMS fact sheets plus more background on IRMAA.

From the public health and medical research front

  • Per Medscape
    • “Roux-en-Y gastric bypass (RYGB) produces maximal weight loss in patients with obesity compared with other surgical procedures and with weight loss drugs, according to a meta-analysis comparing the efficacy and safety of the different treatment options. 
    • “However, tirzepatide, a long-acting glucose-dependent insulinotropic polypeptide (GIP) receptor agonist and glucagon-like peptide-1 receptor agonist (GLP-1 RA), produces comparable weight loss and has a favorable safety profile, reported principal investigator Jena Velji-Ibrahim, MD, MSc, from Prisma Health–Upstate/University of South Carolina School of Medicine in Greenville. 
    • “In addition, there was “no significant difference in percentage total body weight loss between tirzepatide when comparing it to one-anastomosis gastric bypass (OAGB), as well as laparoscopic sleeve gastrectomy,” she said.” 
  • and
    • “Noninvasive surveillance with multitarget stool DNA testing or fecal immunochemical testing (FIT) could potentially match colonoscopy for reducing long-term colorectal cancer (CRC) incidence and mortality. It might also reduce colonoscopies by an estimated 15%-41%.
    • “The greatest reduction would likely be achieved by annual FIT-based surveillance, especially with FIT FOB-Gold at a threshold of at least 32 µg/g feces, according to findings from the Dutch MOCCAS study published in Gastroenterology.
    • “In this cross-sectional observational study, the multitarget DNA test outperformed FIT for detecting advanced precursor lesions, especially serrated polyps. According to long-term-impact mathematical modeling, however, DNA-based surveillance would be more costly than colonoscopy surveillance, whereas FIT would save costs.”

From the U.S. healthcare business front,

  • Altarum recently posted a report on trends in healthcare spending at the U.S. state level, including D.C. from 2019 through 2022.
  • Kaufmann Hall tells us,
    • After hearing reports from health systems about decreasing revenue capture from Medicare Advantage (MA) plans, this graphic dives into some of the trends driving this costly challenge providers are facing. MA plans’ popularity has swelled in recent years as seniors are drawn to the extra benefits and lower out-of-pocket costs. As a result, MA enrollees as a share of total inpatient days roughly doubled across all area types between 2015 and 2022. This trend has likely continued as MA penetration has only grown since 2022. This shift has been tough for providers because most MA plans require prior authorization for certain kinds of care, a burnout-driving and costly administrative demand for providers. Although the number of prior authorizations per MA enrollee has remained stable over recent years, providers are seeing more MA patients, leading to an increased burden. On top of that, the overall prior authorization denial rate jumped to 7.4% in 2022, after hovering around 5.7% for several years prior. These decisions can be overturned, but patients and providers often don’t file appeals, leading to higher rates of uncompensated care and lost revenues for providers. Unfortunately, these higher costs have brought many providers to a breaking point in contract negotiations with MA plans, leading to care disruptions that ultimately hurt patients the most.
  • Bloomberg Law reports,
    • “CVS Pharmacy Inc. and the former president of Cigna Corp.’s Express Scripts asked a federal judge to amend an injunction prohibiting her from joining CVS so that it expires at the same time as her noncompete agreement with Cigna.
    • “CVS notified Amy Bricker on Nov. 6 that it’s terminating her inactive employment status with the company, according to a motion the two filed Thursday in the US District Court for the Eastern District of Missouri. CVS and Bricker argued that fact materially changes the circumstances of the injunction because she “will not, even in the future, perform any active employment duties or responsibilities for CVS.
    • “Bricker’s termination followed a Nov. 6 quarterly earnings call where CVS publicly announced senior leadership changes.
    • “It “obviates any need” for the injunction, CVS and Bricker said, and “has the practical effect of interfering with Ms. Bricker engaging in gainful employment for longer than” the Cigna noncompete, which is set to expire Feb. 3.”