Weekend Update

OPM

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.”

Happy Thanksgiving!

David Ermer–CDC, CMS, FDA, Medical / Rx research, Medicare, NIH, Obesity, OPM, Patient safety, U.S. Healthcare–

The FEHBlog will be back on Friday.

From Washington, DC,

Transition News

  • Govexec tells us,
    • “President-elect Trump has reached an agreement with the Biden administration that will allow his teams to deploy throughout federal government, ending a standoff that had blocked official presidential transition efforts taking place. 
    • “Transition staff assigned to each agency, known as landing teams or agency review teams, will now physically enter headquarters offices throughout government. Once there, they will meet with assigned career senior executive staff, receive already drafted briefings on agency activities and begin the process of exchanging information about existing projects and future priorities.”
  • STAT News reports,
    • “President-elect Trump has chosen Stanford University professor Jay Bhattacharya to lead the National Institutes of Health, his transition announced Tuesday.
    • “If confirmed by the Senate, Bhattacharya would be in charge of implementing the incoming Trump administration’s bold goals to reform the agency. 
  • The Wall Street Journal adds,
    • “Bhattacharya is both a doctor and economist who became known during the Covid-19 pandemic as a co-author of the Great Barrington Declaration, a document that called for ending lockdowns and isolating the vulnerable so that young, healthy people could get infected and build up immunity in the population. 
    • “Other doctors and public-health researchers, including then-infectious disease chief Dr. Anthony Fauci, criticized the document and said its approach was flawed and would lead to unnecessary deaths.”
  • The Hill notes,
    • “President-elect Trump’s choice for deputy secretary of Health and Human Services is Jim O’Neill, an investor and historically close associate of billionaire Peter Thiel, the president-elect said Tuesday.”

Medicare / GLP-1 Drug News

  • The American Hospital Association News informs us,
    • “The Department of Health and Human Services Nov. 26 issued a final rule that expands access to kidney and liver transplants for individuals with HIV by removing clinical research requirements. Specifically, the rule implements a stipulation under the HIV Organ Policy Equity Act, eliminating the need for approval from the clinical research and institutional review board for kidney and liver transplants between donors with HIV and recipients with HIV. The change was based on research showing the safety and effectiveness of such transplants, HHS said. The final rule is effective Nov. 27.
    • “In tandem with the final rule, the National Institutes of Health published a notice seeking public comment on a proposed revision to its research criteria for HOPE Act transplants of other organs, such as heart, lung and pancreas, with a 15-day comment period.”
  • and
    • “The Centers for Medicare & Medicaid Services Nov. 26 proposed changes to the Medicare Advantage and prescription drug programs for contract year 2026. Those changes would permit coverage of anti-obesity medications in the Medicare and Medicaid programs; fortify existing limitations on insurer use of internal coverage criteria and requirements for MA plans to provide coverage for all reasonable and necessary Medicare Part A and B benefits; and apply additional guardrails to insurer use of artificial intelligence to ensure it does not result in inequitable treatment or access to care. CMS also proposes to update MA and Part D plan medical loss ratio reporting requirements to improve oversight, align reporting with commercial and Medicaid reporting, and request additional information on MLR and vertical integration. 
    • “Among other provisions, the proposed rule would require MA plans to make provider directory information more widely available through the Medicare Plan Finder tool; limit enrollee cost sharing for behavioral health services to an amount that is no greater than Traditional Medicare; enhance CMS oversight of MA agent and broker marketing and communication materials; increase insurer reporting requirements related to insurer use of prior authorization and potential health equity implications; and add new requirements governing MA plan use of debit cards to administer enrollee supplemental benefits. Finally, the proposed rule would also codify several provisions in the Inflation Reduction Act, such as capping certain out-of-pocket costs in Medicare Part D, and other pharmacy-related provisions, such as new requirements for Part D sponsors on formulary inclusion and placement of generic drugs and biosimilars.” 
  • Here is a link to the CMS fact sheet about the Medicare Advantage and Part D proposed changes for 2026.
  • KFF already has issued a policy watch about CMS’s proposal to cover GLP-1 drugs for obesity under Medicare Part D and Medicaid beginning in 2026. The FEHBlog is surprised that CMS made this decision knowing that the Inflation Reduction Act has placed financial pressure on standalone Medicare Part D plans.
  • The Wall Street Journal notes,
    • The [GLP-1 drug] proposal, which would have to be finalized by the Trump administration, faces uncertain prospects.
  • In this regard, Beckers Hospital Review shares the recent comments of President-elect Trump’s nominee for HHS Secretary Robert F. Kennedy, Jr., concerning GLP-1 drugs.
  • The Wall Street Journal adds,
    • “Meantime, Mehmet Oz, the choice to run the Centers for Medicare and Medicaid Services, has said on X that the drugs “can be a big help. We need to make it as easy as possible for people to meet their health goals, period.” * * *
  • On a related note, MedCity News discusses “The Promise and Challenge of GLP-1 Medications: Ensuring ROI in Obesity Care.”

Federal Employment Tidbits

  • Federal News Network reports
    • “Federal Executive Boards are looking to expand their offerings to even more federal employees working outside of the Washington, D.C., region.
    • “After reporting successful training sessions, recruitment events and cost savings in the last fiscal year, the Office of Personnel Management sees an opportunity to extend FEBs’ reach to more than double the number of feds who can access the program’s resources.
    • “The expansion would now be possible, after the FEB program went a restructuring, as well as recently developing a new funding model, OPM said.
    • “This transformation is designed to enhance the FEBs’ effectiveness in fostering interagency collaboration, better serve the 85% of federal employees located outside Washington, D.C., and expand FEBs’ reach to areas with significant federal activity but no FEB presence,” OPM wrote in its fiscal 2023 FEB annual report, published earlier this month.”
  • FedWeek lets us know,
    • “Availability of telework has had a positive impact on recruitment and retention, a sampling of four agencies told GAO, but its effect on customer service and other agency operations is hard to gauge—and three of the four have done little to even try.
    • “The effect on productivity has become a major focus in the ongoing debate over agency telework levels that, although well below the peak of the pandemic period, remain high by historic measures. The GAO report, while not conclusive, adds information to a debate that may result in moves to restrict telework starting in January by the new Congress, the Trump administration, or both.”

FDA News

  • Per Fierce Pharma,
    • “In 2001, a Time Magazine cover story touted Novartis’ targeted leukemia treatment Gleevec (imatinib) as a new kind of “ammunition in the war against cancer.” Along with a picture of the Gleevec pills, Time exclaimed: “These are the bullets.”
    • “Twenty-three years later, patients no longer need to take a “bullet” to reap the benefits of imatinib as Shorla Oncology has scored an FDA approval for its strawberry-flavored drink version of the treatment. Dubbed Imkeldi, it becomes the first oral liquid form of imatinib, Shorla said in a press release.
    • “The therapy can help patients combat myelodysplastic syndrome/myeloproliferative disease (MDS/MPD), gastrointestinal tumors (GIST) and cancers such as chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).”
  • Per MedTech Dive,
    • “Zimmer Biomet said Monday that it received approval for a cementless partial knee replacement implant in the U.S.
    • “The Oxford Cementless Partial Knee launched in England in 2004. The device is established in Europe, where the company said it has a 60% market share, but will be the first product of its type available in the U.S. The orthopedic company plans to launch the implant in the first quarter of 2025.
    • “Zimmer has identified the device as a good fit for ambulatory surgical centers (ASC) and CEO Ivan Tornos has forecast the product will be one of the top three knee growth drivers in the U.S.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “A highly anticipated obesity-drug candidate from biotech Amgen helped patients shed a significant amount of weight in a mid-stage study but fell short of the loftier expectations of some investors. 
    • “Subjects taking Amgen’s MariTide lost 20% of their body weight compared with those who received placebos, Amgen said Tuesday. Analysts had generally expected the drug to achieve weight reduction of 20% or more.
    • “About 11% of subjects dropped out of the study because of side effects, the most common of which included nausea and vomiting.”
  • BioPharma Dive offers a tracker for obesity drug trials.
  • Beckers Hospital Review relates,
    • “A new study on asthma medication Singulair has raised concerns about its potential mental health side effects, USA Today reported Nov. 24. 
    • “The study, presented by the FDA at the American College of Toxicology meeting in Austin, Texas, found that the drug binds to multiple brain receptors linked to mood, cognition, sleep and impulse control. While the research does not confirm if this binding causes harmful side effects, experts warned it could be a significant concern. 
    • “Singulair, commonly prescribed for asthma and allergy symptoms, has been linked to severe neuropsychiatric issues, including anxiety, depression, hallucinations, irritability and suicidal thoughts, USA Today reported.
    • ‘In 2020, the FDA added a boxed warning to the drug, highlighting the risk of severe mental health side effects. Since its introduction in 1998, Singulair has been associated with dozens of suicides and other psychiatric disorders, with reports of adverse effects continuing into recent years. 
    • “Despite the new findings, the FDA said it will not immediately update the drug’s label. The agency also emphasized that more research is needed to fully understand the extent of the drug’s impact on the brain, according to the report.”
  • The National Institutes of Health shares news about “Sleep and heart healing | Liver-brain communication | Characterizing sensory nerves.”
  • Beckers Hospital Review offers a “‘straight-A’ hospital’s safety playbook.”

From the U.S. healthcare business front,

  • Fierce Healthcare points out,
    • “Pittsburgh-based health insurer and provider Highmark Health has brought in $529 million in net income through the first three quarters of the year, according to its latest financial details released Tuesday.
    • “That’s on $22.1 billion in revenue through the first nine months of 2024, along with $273 million in operating gain.
    • “Highmark said that its financial performance is driven by its health plans along with increased volumes at its Allegheny Health Network (AHN). As of Sept. 30, the AHN saw a 3% increase in inpatient discharges and observations as well as 7% more outpatient registrations compared to the same time last year.
    • “In addition, the AHN logged a 5% increase in physician visits and a 6% increase in visits to the emergency room.”
  • Modern Healthcare reports,
    • “Community Health Systems scrapped a $120 million deal to sell three Pennsylvania hospitals and related facilities to WoodBridge Healthcare.
    • “CHS and WoodBridge mutually decided to dissolve the agreement Friday due to WoodBridge’s inability to satisfy funding requirements, according to a Tuesday news release. Investment banking firm Zeigler was unable to sell the bonds needed to fund the acquisition, despite earlier indications of confidence in the bond sales, WoodBridge said in a separate release.”
  • Chief Healthcare Executive (11/22, Southwick) reported, “The majority of hospital and health care facility reviews on Yelp are negative, according to a new study.” Investigators found that “in March 2020, 54.3% of reviews on Yelp were positive, but that number has dropped to 47.9%” Chief Healthcare Executive adds, “Since the second half of 2021, positive reviews haven’t surpassed 50%.” The research was published in JAMA Network Open. Thanks, Covid.

Weekend Update

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medicare, OPM, U.S. Healthcare–

From Washington, DC,

  • The House of Representatives and the Senate are on District / State work breaks from Capitol Hill this week due to the Thanksgiving holiday.
  • The Hill offers backgrounds on the Food and Drug Administration commissioner, Centers for Disease Control director, and Surgeon General nominees that President-elect Trump announced Friday evening.
  • STAT News reports
    • “A conservative federal judge in Texas has ruled in favor of UnitedHealth Group, saying the federal government unlawfully factored in a “disputed” phone call to lower UnitedHealth’s Medicare Advantage ratings. 
    • “The Centers for Medicare and Medicaid Services will now have to revise UnitedHealth’s 2025 Medicare Advantage ratings by taking out the call center metric, and “immediately publish the recalculated star ratings in the Medicare Plan Finder,” Judge Jeremy Kernodle wrote in his ruling.”
    • Congrats UHG.
    • “Four other large Medicare Advantage insurers — Humana, Elevance Health, Centene, and Blue Cross Blue Shield of Louisiana — have also sued Medicare for downgrading their 2025-star ratings. The lawsuits from Humana and Centene similarly involve the government’s evaluation of their call centers.”
  • Federal News Network tells us,
    • “The Office of Personnel Management has a new leader to focus specifically on federal employees working in HR. Jeff Bardwell will be the first-ever senior executive to serve as the advisor for human resources workforce programs at OPM. In the new position, Bardwell will be tasked with developing and managing the direction of the HR workforce governmentwide. His work will likely include defining HR career paths and improving HR training and professional development opportunities. Bardwell previously spent 15 years working at the Department of Homeland Security.”

From the public health and medical research front,

  • The New York Times discusses how healthcare can unnecessarily take time away from senior citizens.
    • “[S]lowing the health care treadmill — an approach Dr. Montori has called “minimally disruptive medicine” — is possible.
    • “If doctors and clinics and health care systems paid attention to ways to lessen the burden, we’d all be better off,” Dr. Ganguli said. “And some are fairly simple.”
    • “One strategy: reducing what experts call “low-value care.” Her research has confirmed what critics have pointed out for years: Older people receive too many services of dubious worth, including prostate cancer screening in men over 70 and unneeded tests before surgery.”
  • Fortune Well shares “Tips and habits for getting a good night’s rest and boosting your health.”
  • The Wall Street Journal offers an obituary for “Janelle Goetcheus, the ‘Mother Teresa of Washington, D.C.,’ dies at 84. She felt a pull to practice medicine and a call to serve God—the two were always intertwined.
    • “Goetcheus [and her husband, a Methodist minister] spent the [last] half-century treating the unhoused in Washington, D.C. She helped open clinics, organizations and warm buildings to support and care for them. She also visited patients on park benches and in the street—treating people where they are was central to her mission.
    • “Sometimes called the “Mother Teresa of Washington, D.C.,” Goetcheus was best known for co-founding Christ House with a group that included her husband, the Rev. Allen Goetcheus. A “medical respite,” Christ House is a place where men who are no longer sick enough to be in a hospital, but don’t have an appropriate place to convalesce, can live while they recover. It was also the home where the couple raised their three children and where she died, Oct. 26, at the age of 84.” * * *
    • “We wanted to learn to be with people and not just to do for people,” Goetcheus said in the oral-history interview.”
    • RIP Dr. Goetcheus.

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “A growing number of companies have begun to offer employees access to menopause-related benefits in their health insurance, including paid time off, access to health providers knowledgeable about menopause, coverage of medication for menopause symptoms, and even altered work schedules and relaxed dress code options. These benefits are meant to help employees cope with symptoms such as hot flashes, depression and other physical discomforts.
    • “The benefits are designed to meet the needs of people dealing with menopause and of their employers, who are adding such coverage to help retain employees, many who have decades of experience, are in management and senior leadership positions or are in line for those posts.
    • “Among the companies offering a variety of menopause-related benefits are Microsoft, Genentech, Adobe and insurer Healthfirst.”
  • BioPharma Dive reports,
    • “The Food and Drug Administration has approved a new medicine for a deadly genetic heart condition, boosting its developer, BridgeBio Pharma, and teeing up a battle for control of a lucrative market targeted by several drugmakers.
    • “The agency on Friday cleared Attruby, known scientifically as acoramidis, for people with a cardiac form of transthyretin amyloidosis, a progressive disease that leads to heart failure and death.
    • “In testing, Attruby helped keep people alive and out of the hospital longer than those who’d received a placebo. Treatment was also associated with improvements in quality of life as well as markers of heart health.
    • “Notably, the drug is approved to prevent hospitalization or death resulting from heart complications of transthyretin amyloidosis with cardiomyopathy. Investors had been skeptical BridgeBio would earn such a distinction from regulators, leading to doubts about Attruby’scommercial prospects. 
    • “BridgeBio priced Attruby at just under $19,000 for a 28-day supply, translating to an annual list cost of about $244,000.”
  • McKinsey & Company considers what’s next for AI and healthcare.
    • In healthcare—with patient well-being and lives at stake—the advancement of AI seems particularly momentous. In an industry battling staffing shortages and increasing costs, health system leaders need to consider all possible solutions, including AI technologies. “Organizations are eager to use generative AI to help enhance how healthcare stakeholders work and operate,” write McKinsey’s Jessica Lamb and coauthors, “but some are still adopting a wait-and-see approach.” Where do you stand? Explore these insights to get up to date on AI and healthcare topics including: 
      • Adding artificial intelligence to nurses’ toolbox
      • Making coverage and cost information more understandable
      • AI impact on the payment integrity (PI) value chain
      • AI use cases in claims processing, enrollment, and underwriting.
  • HR Dive provides “a roundup of numbers from the last week of HR news — including the percentage of employers covering GLP-1s for obesity treatment [44%].”

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.

Thursday Miscellany

David Ermer–CDC, CMS, FDA, Generative AI, Medical / Rx research, Medicare, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “President-elect Donald Trump said he would nominate environmental lawyer and vaccine skeptic Robert F. Kennedy Jr. to serve as health and human services secretary, putting a noted critic of U.S. public policy atop the country’s vast health bureaucracy. 
    • “Kennedy has promised sweeping changes to food-and-drug regulation and government-funded scientific research, in recent days saying the Food and Drug Administration’s nutrition department needed to be eliminated and warning the agency’s employees to “pack your bags.”
    • “Kennedy, 70 years old, abandoned his independent presidential bid in August and endorsed Trump, promising that he and the Republican would work to “make America healthy again.”
    • “Kennedy said on social media after his nomination that “we have a generational opportunity to bring together the greatest minds in science, medicine, industry, and government to put an end to the chronic disease epidemic.”
  • Per an HHS press release,
    • “Today, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), announced a new nationwide campaign to raise public awareness of the National Maternal Mental Health Hotline (1-833-TLC-MAMA). The National Maternal Mental Health Hotline is a cornerstone of the Biden-Harris Administration’s broader efforts to improve maternal health and supports HRSA’s ongoing initiative to reduce maternal mortality and health disparities. While mental health conditions are the leading cause of pregnancy-related deaths, more than 80 percent of pregnancy-related deaths are preventable according to the Centers for Disease Control and Prevention (CDC).
    • “As part of the campaign, HHS will collaborate with companies and organizations such as retailers, grocers, pharmacies, and health and community associations to publicize mental health resources for moms and pregnant women in everyday locations. The first six Maternal Mental Health Champions announced today have thousands of locations and a broad presence in all 50 states, Washington, D.C., Puerto Rico, and the U.S. Virgin Islands. HRSA Deputy Administrator Jordan Grossman announced this campaign in conjunction with HRSA’s latest state Enhancing Maternal Health Initiative convening in Portland, Oregon.” * * *
    • “The National Maternal Mental Health Hotline is a safe space for pregnant women and new moms to get the emotional and mental health support they need, and we want to continue to reach even more pregnant women, new moms, and their loved ones with this vital support,” said HRSA Administrator Carole Johnson. “That’s why we are excited to partner with grocery stores, pharmacies, and other organizations to help get the word out about this important resource for in communities across the country.” * * *
    • “For more information on the National Maternal Mental Health Hotline and to download new promotional materials, visit: https://mchb.hrsa.gov/national-maternal-mental-health-hotline.”
  • Healthcare Dive lets us know,
    • “The Biden administration is moving to lessen the importance of a controversial metric used to calculate valuable Medicare Advantage star ratings that’s been at the center of recent lawsuits.
    • “UnitedHealthcare, Centene and Humana have all sued the government this fall for downgrading their quality scores based on assessments of their customer support centers. Payers argued the measure had an outsized impact on final star ratings, and it now seems regulators might agree.
    • “We have already put in place that [the call center metric] is going to have a smaller weighting on star ratings moving forward,” CMS Medicare Director Meena Seshamani said Wednesday at the Milken Institute’s Future of Health Summit in Washington, D.C.”
  • Federal News Network interviews OPM Director Rob Shriver about the Federal Employee Benefits Open Season.
  • Tammy Flanagan, writing in Govexec, identifies federal and postal employee “retirement decisions that require careful consideration since they cannot be changed.”
  • Federal News Network tells us,
    • “The Postal Service is reporting a deeper financial loss than it’s seen in recent years and is calling on Congress and the incoming Trump administration to address rising costs that are beyond its control.  
    • “USPS reported a $9.5 billion net loss for fiscal 2024, despite year-over-year growth in revenue and a reduction in its controllable expenses. The agency saw a $6.5 billion loss in FY 2023. 
    • “USPS officials said 80% of the agency’s losses come from fixed costs — including pension contributions for its retirees and workers’ compensation claims for employees injured on the job.  
    • “The agency will not seek to raise mail prices in January 2025, but it plans to keep setting higher prices each July and January after that, through the end of 2027.
    • “USPS projections show the agency will end FY 2025 with a $6.9 billion net loss for FY 2025 and is falling short of its “break-even” goal under a 10-year reform plan.” 

From the public health and medical research front,

  • STAT News reports,
    • “A Canadian teenager who is in critical condition after contracting H5N1 bird flu was infected with a version of the virus that is different from the one circulating in dairy cattle in the United States, Canadian authorities announced Wednesday.
    • “The National Microbiology Laboratory in Winnipeg confirmed the infection was indeed caused by the H5N1 virus. But genetic sequencing showed that it is of a genotype that has been found in wild birds, not the version that has been circulating in dairy cattle in the U.S. 
    • “Canada has been doing surveillance in dairy cows looking for the virus, but to date has not detected it in any herds.
    • “Bonnie Henry, British Columbia’s provincial health officer, told STAT in an interview that she’d been expecting these genetic sequencing results. “That’s what we’ve been seeing consistently,” she said.”
  • HCPLive informs us,
    • “Initiation of population-wide screening for chronic kidney disease (CKD) followed by treatment with conventional CKD therapy combined with sodium-glucose cotransporter-2 (SGLT2) inhibitors would be cost-effective for US adults when initiated at 55 years of age, according to findings from a recent study.
    • “Results showed screening every 5 years combined with SGLT2 inhibitors from 55-75 years of age would cost $128,400 per quality-adjusted life year (QALY) gained. While initiation of screening at 35 or 45 years of age produced larger population health benefits, these strategies incurred additional costs totaling> $200,000 per QALY gained.
    • “In the absence of effective CKD treatment options at the time, in 2012, the US Preventive Services Task Force found insufficient evidence to show screening and early detection of CKD improved clinical outcomes. However, the recent emergence of SGLT2 inhibitors as a practice-changing therapy for CKD has prompted clinical guideline organizations to update standard of care recommendations for CKD to include these medications.”
  • Per BioPharma Dive,
    • “PTC Therapeutics on Wednesday won Food and Drug Administration approval for Kebilidi, the first gene therapy cleared in the U.S. for direct administration to the brain.
    • “The treatment is designed for patients with aromatic L-amino acid decarboxylase, or AADC, deficiency, a condition that affects the way neurons transmit information to other cells. The potentially fatal disorder typically manifests in the first six months after babies are born and affects all aspects of their lives, both physical and mental.
    • “Kebilidi is designed to deliver a functioning DDC gene into the body, correcting the genetic defect that causes the disorder. It’s administered by a neurosurgeon in four infusions in one session.”
  • Healthcare Dive relates,
    • “Increased telehealth utilization wasn’t linked to more low-value services at primary care clinics, according to a study published this week in JAMA Network Open.
    • “The research found no association between practices that used high levels of telehealth and most types of low-value care, or services that have no clinical benefit for patients and rack up costs.
    • “The findings could reassure policymakers who have raised concerns that virtual care could increase unnecessary or wasteful services and drive-up healthcare spending, the study’s authors wrote.” 
  • The Wall Street Journal reports,
    • “Intermittent fasting probably isn’t the health hack you hoped it would be.
    • “More studies suggest the tactic can help you lose weight, but likely isn’t a silver bullet for other health improvements like lowering your inflammation levels or lengthening your lifespan. And some evidence suggests fasting can make it harder to build and retain muscle.
    • “People were hoping it was this magical thing that did amazing things for them,” says Krista Varady, a professor of nutrition at the University of Illinois Chicago who has been studying intermittent fasting for 20 years. “All it does is help people eat less.”

From the U.S. healthcare business front,

  • AHIP lets us know,
    • “With more than half of Americans – approximately 180 million people – receiving health care coverage through work, a new nationwide poll finds that a strong majority are satisfied with their current employer-provided plans (75%) and prefer to get their coverage through an employer rather than through the federal or state government (74%).
    • “The poll found that Americans’ satisfaction with employer-provided coverage is driven by the comprehensive coverage (49%), affordability (48%) and choice of providers (45%) their plans provide.” * * *
    • “The national survey of 1,000 people with employer-provided coverage was conducted online from July 10-19, 2024, with a margin of error of +/- 3%. 
      • “Click here to view the infographic.
      • “Click here to view the survey results.
      • “Click here to view a slide presentation of the survey results.”
  • Fierce Healthcare reports about the second day of its Fierce Health Payer Summit.
  • The FEHBlog took sometime today listening to the HCPLAN Summit, which was held in Baltimore. At the Summit, HCPLAN released the 2024 results of its Alternative Payment Models survey.
  • Adam Fein, writing in his Drug Channels blog, points out,
    • “Uh oh. As I predicted, the stand-alone Medicare Part D prescription drug plans (PDP) market is vanishing.
    • “For 2025, DCI’s exclusive analysis of Center for Medicare & Medicaid Services’ (CMS) data reveals that the number of PDPs will drop to a historic low. What’s more, the share of plans with a preferred cost sharing pharmacy network will fall to its lowest rate in more than 10 years. Check out the distressing charts below and our review of the remaining national players (Aetna, Cigna, Humana, UnitedHealthcare, and WellCare). 
    • “The destruction of the Part D market marks yet another unintended consequence of the Inflation Reduction Act of 2022 (IRA). The IRA makes PDPs less economically viable and will drive even more seniors into Medicare Advantage Prescription Drug (MA-PD) plans—despite the challenges facing those plans. The 2025 decline will occur even after CMS gifted $7 billion to PDPs to prevent a complete collapse of the 2025 market. 
    • “Legislate in haste. Repent in leisure.”
  • STAT News reports,
    • “In a move to safeguard the company’s dominant position in cancer, Merck said Thursday it will license a new cancer drug from LaNova Medicines, a Shanghai-based firm, for $588 million upfront and as much as $2.7 billion in potential milestone payments.
    • “The cancer immunotherapy Keytruda, Merck’s most important product and the best-selling drug in the world with $23 billion in annual sales, is set to lose patent protection and face competition from generic drugmakers as early as 2028, and investors are already fretting about what will happen at Merck when revenues from the medicine begin to decline.”
  • Healthcare Dive lets us know,
    • “A group of health systems, led by Boston-based Mass General Brigham, is hoping to solve that problem. 
    • “On Wednesday, the academic medical center launched the Healthcare AI Challenge Collaborative, which will allow participating clinicians to test the latest AI offerings in simulated clinical settings. Clinicians will pit models against each other in head-to-head competition and produce public rankings of the commercial tools by the end of the year.
    • “Participating health systems say that the chance to directly compare AI products is overdue.”
  • Per Fierce Healthcare,
    • “Blue Cross Blue Shield of Massachusetts members will benefit from an expanded partnership with Maven Clinic, a new doula pilot program and more caregiving support in collaboration with Cleo, the company announced Nov. 13.
    • “Its doula program, called Accompany Doula Care, connects “racially and ethnically diverse” members with a trained doula. The pilot will collect data to assess whether the program is adequately reaching members through the birthing timeline, including prenatal visits, in-person support during childbirth and postpartum visits.
    • “Black women experience higher levels of maternal morbidity, Blue Cross’ health equity report found.
    • “Eligible Blues members will also have access to Maven Clinic’s Menopause and Midlife Health program. This program can be utilized as a buy-up for self-insured accounts, a news release explains.”
  • and
    • “Amazon One Medical is rolling out a new service to provide Prime members access to clinical treatments for common health and lifestyle conditions like men’s hair loss and anti-aging skin care.
    • “The new service builds on Amazon One Medical’s existing Pay-per-visit telehealth service that offers healthcare for more than 30 common conditions.
    • “The new service offers a subscription plan with low, upfront monthly pricing for a clinical visit, treatment plan, and free medication delivery. The service initially focuses on five conditions: anti-aging skin care treatment, men’s hair loss, erectile dysfunction, eyelash growth, and motion sickness.
    • “Through this service, Prime members can get anti-aging skin care treatment from $10/month; men’s hair loss solutions from $16/month; ED treatment from $19/month; eyelash growth solutions from $43/month; and treatment for motion sickness from $2/use—using Prime Rx at checkout, the company said in a blog post Thursday.”

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.”