Thursday Miscellany

Mental health care

Thursday Miscellany

David Ermer–CMS, FDA, Medical / Rx research, Medicare, Mental health care, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Per an HHS press release,
    • Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), is finalizing policies that continue to strengthen enrollee protections and guardrails to ensure Medicare Advantage and Medicare Part D (Part D) prescription drug plans best meet the needs of people with Medicare. The Contract Year (CY) 2025 Medicare Advantage and Part D final rule builds on existing CMS policies to promote competition, increase access to care, including important behavioral health services, and protect individuals from inappropriate marketing and prior authorization. * * *
    • [For example,] CMS is finalizing greater flexibility for Part D plans to substitute, more quickly, lower cost biosimilar biological products (biosimilars) for their reference products so that enrollees may have faster access to equally effective, but potentially more affordable, drug treatment options. * * *
    • View a fact sheet on the final rule at cms.gov/newsroom.
  • From the AHA News,
    • “Primary care providers who commit to practicing two years in a health professional shortage area can initially receive up to $75,000 in loan repayment under the National Health Service Corps Loan Repayment Program, $25,000 more than previously and the first significant increase in 30 years, the Health Resources and Services Administration announced April 4. Participants who extend their service beyond two years can receive additional funding under the program. HRSA also will offer up to $5,000 in additional loan repayment to participants who can demonstrate fluency in Spanish and commit to practice in a high-need area serving patients with limited English proficiency.”
  • The International Foundation of Employee Benefit Plans lets us know,
    • “The Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act (MHPAEA) requires group health plans that provide mental health or substance use disorder (MH/SUD) benefits to offer parity between coverage of physical health conditions and mental health conditions. The Department of Labor (DOL) Employee Benefits Security Administration (EBSA) enforces MHPAEA and reports annually to Congress on how agency investigators are working with plan sponsors and administrators to bring them into compliance.
    • “Recent DOL reports on MHPAEA enforcement indicate several pitfalls that self-funded plan sponsors and their administrative service providers should avoid in order to be compliant with mental health parity rules. A new priority in the 2023 report was impermissible exclusions of key treatments for MH/SUD.
    • One-Minute Summary
      • Recognize that autism spectrum disorder, opioid use disorder and eating disorders are mental health conditionsand therefore treatment of these disorders are mental health benefits covered by mental health parity laws.
      • Blanket exclusions of ABA therapy for autism spectrum disorder, nutritional counseling for eating disorders, and medication-assisted treatment (MAT) and medications for opioid use disorder (MOUD) are impermissible.
      • Methods that participants use to access care should be in parity. Prior authorization, gatekeepers such as EAP referrals and telehealth are impermissible barriers to access mental health benefits.
  • Per an OPM press release,
    • In the first week of the Biden-Harris Administration, President Biden revoked an Executive Order issued by the previous Administration that risked altering our country’s long-standing merit-based civil service system, by creating new excepted service schedule, known as “Schedule F,” and directing agencies to move potentially large swathes of career employees into this new excepted service status. This attempt would have stripped career civil servants of their civil service protections that ensure that decisions to hire and fire are based on merit, not political considerations.  
    • The [OPM] final rule [released today] advances these important policy goals by:  
      • Clarifying that the status and civil service protections an employee has accrued cannot be taken away by an involuntary move from the competitive service to the excepted service, or from one excepted service schedule to another. Once a career civil servant earns protections, that employee retains them unless waived voluntarily.  
      • Clarifying that the phrase “confidential, policy determining, policymaking, or policy-advocating” positions—a term of art to describe positions that lack civil service protections—means noncareer, political appointments. This rule prevents that exception from being misapplied to career civil servants.  
      • Establishing procedural requirements for moving positions from the competitive service to the excepted service and within the excepted service. This change both creates transparency and establishes an appeals process for federal employees when any such movement is involuntary and characterized as stripping employees of their civil service protections.   

From the public health and medical research front,

  • The Society for Human Resources Management tells us,
    • “Anxiety has skyrocketed in recent years, now becoming the top mental health issue plaguing workers, new data shows.
    • “An analysis of more than 300,000 U.S. cases from mental health provider ComPsych found that nearly a quarter of people (24 percent) who reached out to ComPsych for mental health assistance in 2023 did so to get help with anxiety.
    • “That makes anxiety the No. 1 presenting issue reported by U.S. workers, topping depression, stress, relationship issues, family issues, addiction and grief, ComPsych said.”
  • MedPage Today notes,
    • New U.S. hepatitis C infections dropped slightly in 2022, a surprising improvement after more than a decade of steady increasesopens in a new tab or window, federal health officials said Wednesday.
    • Experts are not sure whether the 6% decline is a statistical blip or the start of a downward trend. Seeing 2023 and 2024 data, when it’s available, will help public health officials understand what’s going on, said Daniel Raymond, director of policy at the National Viral Hepatitis Roundtable, an advocacy organization.
    • “We’ve had a decade of bad news … I am cautiously encouraged,” he said. “You always want to hope something like this is real, and a potential sign that the tide has turned.”
  • STAT News reports,
    • “The booming class of GLP-1 drugs that includes Ozempic and Wegovy is not only effective for diabetes and obesity, but is also showing early potential to help with conditions involving the brain, like mental health disorders, Alzheimer’s, and even, as new study results suggest — Parkinson’s disease.
    • “In a Phase 2 trial, patients with early Parkinson’s disease taking an older GLP-1 diabetes drug called lixisenatide experienced no worsening of motor symptoms over a year, in contrast to patients on placebo who did, according to the study, published Wednesday in the New England Journal of Medicine.
    • “The difference between the groups — as measured by a test looking at someone’s tremors and rigidity — was small, almost but not quite reaching what is deemed to be a clinically significant difference. Still, the authors said they were encouraged that patients on the drug did not get worse, and the findings add to a growing body of research that suggests this class of medications holds potential as a new way of addressing Parkinson’s, a slow-moving, debilitating disorder that currently lacks any treatments that can halt disease progression.”
  • and
    • “Moderna may be best known for its Covid-19 vaccine, but since its start, it’s always been set on developing therapies.
    • “It’s run into some hurdles as it’s pioneered turning mRNA — the strand of genetic material that’s at the heart of Moderna’s approach — into medicines. But the company’s vision of making cells into their own drug factories is showing signs of progress.
    • “On Wednesday, scientists reported interim results from an early study of Moderna’s most advanced rare-disease therapy, a treatment for propionic acidemia, a metabolic condition in which the body makes defective versions of enzymes that are required to break down fats and proteins. While the study primarily focused on safety and testing different doses, some patients — most of the participants were children — saw a reduction in the life-threatening metabolic emergencies that can crop up with the disease.
    • “And while most patients reported such side effects as fever and vomiting, they broadly wanted to stay on the drug even after the trial period wrapped up, according to the study, published in the journal Nature.”

From the U.S. healthcare business front,

  • American Hospital Association News informs us,
    • “Almost half of rural hospitals had negative total margins in 2022 and negative patient care margins both before and after the COVID-19 pandemic, according to a report prepared for the AHA by faculty at the Virginia Commonwealth University College of Health Professions. When provider relief funds are excluded from margins, the average total margin for rural hospitals was lower in 2022, the most recent year with data available, than in any year since 2017.” 
  • Mercer Consulting looks at the performance of exclusive provider organizations.
    • “We’re seeing growing adoption of network configurations that differ from the traditional broad PPO network. This might mean eliminating out-of-network benefits, offering a plan with a narrow network of high-performing providers, or both. According to our Survey on Health and Benefit Strategies for 2024, 24% of large employers (those with 500 or more employees) now offer a medical plan option with a High-Performance Network curated by a carrier. Most often, these are plans offered by a national carrier in which the providers are a subset of the carrier’s larger Preferred Provider Organization network and are selected based on quality and cost metrics. A few independent provider networks (for example, Centivo and Imagine Health) have gained some traction as well. The largest employers are moving the fastest – 38% of companies with 20,000 or more employees offer some type of high-performance network.” 
  • Healthcare Dive reports,
    • “Walmart is pushing back expansion plans for its health center superstores, as retail giants struggle to right-size their primary care networks.
    • “The company plans to open 22 health centers this year, according to a Walmart spokesperson. Previously, the retail giant said it would open more than 30 locations in 2024.
    • “Walmart plans to open 18 centers in Texas and another four in the Kansas City metro area, the spokesperson said. The clinic openings will start this month in Houston, and run throughout the fall.”
  • According to BioPharma Dive,
    • “Amylyx Pharmaceuticals is pulling from market one of the few approved treatments for ALS.
    • “Rarely do drugmakers voluntarily withdraw products. In Amylyx’s case, the decision comes just weeks after a large clinical trial meant to confirm the benefits of its medicine instead found it no better than a placebo at slowing the fatal, nerve-destroying disease.
    • “Starting Thursday, the medicine, which is sold as Relyvrio in the U.S. and Albrioza in Canada, will no longer be available for new patients. Those who are taking it and wish to continue may enter a free drug program. Additionally, a phase of that large trial that allows participants to continue on Relyvrio remains ongoing.”
  • MedTech Dive points out,
    • “The Food and Drug Administration granted de novo clearance to an AI tool to help clinicians predict and diagnose sepsis, the first time the agency has authorized such a tool.
    • “The Sepsis Immunoscore software, developed by Chicago-based Prenosis, provides a risk score for clinicians on a patient having or developing sepsis within 24 hours. The score is based on 22 parameters, including respiratory rate, blood pressure and white blood cell count. 
    • “Hospitals already use early sepsis detection tools, despite lacking FDA review. The agency clarified in a final guidance in 2022 that clinical decision support software that provides a risk score or probability of a condition should be regulated as a medical device.”

Monday Roundup

David Ermer–CDC, CMS, FDA, Medical / Rx research, Medicare, Mental health care, Obesity, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • American Hospital News tells us,
    • “The Centers for Medicare & Medicaid Services April 1 finalized proposed changes to Medicare Advantage plan capitation rates and Part C and Part D payment policies for calendar year 2025, which the agency estimates will increase MA plan revenues by an average 3.7% from 2024 to 2025.
    • “The notice implements expected changes to the Part C risk adjustment model that were finalized in the CY 2024 final rule and are being phased-in over three years, such as transitioning the model to reflect ICD-10 condition categories and using more recent data available for fee-for-service diagnoses and expenditures, in addition to providing technical updates to the methodology for CY 2025.
    • “It also finalizes technical updates to the Part C and D star ratings; includes certain adjustments to provide stability for the MA program in Puerto Rico; and implements changes to the standard Part D drug benefit required by the Inflation Reduction Act of 2022, including capping annual out-of-pocket costs for people with Medicare Part D at $2,000 in 2025.” 
  • Per an AHIP press release,
    • “Following the release of the final Medicare Advantage and Part D rate notice from the Centers for Medicare & Medicaid Services (CMS), AHIP President and CEO Mike Tuffin issued the following statement:
      • “These policies will put even more pressure on the benefits and premiums of 33 million Medicare Advantage beneficiaries who will be renewing their coverage this fall. It is important to note that the Medicare Advantage and Part D programs are already undergoing a number of significant regulatory and legislative changes. Moreover, the cost of caring for Medicare Advantage beneficiaries is steadily rising.
      • “Over the past several weeks, scores of bipartisan members of Congress and a diverse array of stakeholders have reinforced their strong support for Medicare Advantage. We appreciate these policymakers and organizations who stood up for the high-quality, affordable coverage and care seniors and people with disabilities count on in Medicare Advantage.”
    • “To view AHIP’s comment letter to CMS, click here.”
  • BioPharma Dive identifies five FDA decisions to watch in the second quarter of 2024, which began today.
  • Federal News Network tells us,
    • “The National Association of Letter Carriers tracks about 150 of these acts of heroism from its members every year. But each year, the union recognizes a select few for extraordinary acts of service.”The National Association of Letter Carriers tracks about 150 of these acts of heroism from its members every year. But each year, the union recognizes a select few for extraordinary acts of service.
    • “Some of NALC’s Letter Carrier Heroes of the Year put their own safety on the line to help save lives. Others led toy drives in their community and held annual charity concerts to make the holiday season extra special for families in need.
    • “NALC National President Brian Renfroe said letter carriers provide an essential service to their customers, and are the “eyes and ears of their communities.”
    • “No one knows our communities and our neighborhoods like letter carriers. We deliver on our routes six and even seven days a week. We get to know our customers. We get to know them better each and every day,” Renfroe said during an award ceremony last Wednesday.”
  • OPM offers a “Readout: OPM Director Kiran Ahuja Visits Houston to Tour NASA Space John Center and Deliver Remarks at the U.S. Customs and Immigration Services Naturalization Ceremony.”  
    • “Director Ahuja delivered remarks at a Naturalization Ceremony at the M.O. Campbell Educational Center. Ahuja welcomed 1,304 new citizens and presented certificates to members of the military and citizens with disabilities.   
      • “In her remarks, Ahuja shared her story and her parent’s journey to the United States, “I can still hear the pride in their voices when they spoke about coming to America and the opportunities this country opened for them. That gratitude led to a sense of purpose – to be engaged citizens; to always vote, because democracy is a gift that so many around the world live without; and to become meaningful part of the communities that we called home.”   
      • “Ahuja encouraged the group of newly naturalized citizens to be empowered by their diverse background and experiences, saying that “now that you’re here, know that you are every bit as important to America as America is to you. You are the future of this country – you will carry on the rich history of a nation made vibrant by the contributions of immigrant communities.”  
      • “Ahuja shared a note for those as new citizens looking to serve their communities and make an impact – stating, “there’s no better place to make a difference than the federal government.  We have influence in every sector and every corner of the country. Whatever your dream job is, there’s a version of it with the federal government. And no matter where you live, there are federal opportunities right there in your community.” 
  • Medscape calls attention to red flags to quicken ovarian cancer diagnosis.

From the public health and medical research front,

  • ABC News reports,
    • “Mpox, formerly known as monkeypox, cases are on the rise here in the U.S., with nearly double the number of infections compared to the same time last year, according to Centers for Disease Control and Prevention data.
    • “While the magnitude of the outbreak experienced in 2022 – where national cases topped 32,000 – is largely over, some high-risk groups need to continue taking precautions, experts say.
    • “Most of the cases that we’re seeing reported are either unvaccinated or under-vaccinated, meaning they either never received a vaccine, or they only got one dose,” Dr. Jenni McQuiston, deputy director of the CDC’s high consequence pathogens and pathology division told ABC News.
    • “The Jynneos vaccine comes in two doses and is recommended for those who have been exposed to someone with mpox as well as those who had a sex partner in the past 2 weeks who was infected. There are currently no recommendations for a booster. Locations offering the free vaccine can be found on the CDC website.
    • “Others eligible for the shot are those who identify as gay, bisexual, or a man who has sex with other men who have had more than one sexual partner or been diagnosed with more than one sexually transmitted disease in the past six months. Those with immune-compromising conditions, such as HIV, are also eligible.”
  • The American Medical Association tells us what doctors wish their patient knew about the contagious norovirus.
  • The Hill informs us,
    • “Sexually transmitted disease rates are rising among adults 55 years old and older, according to data from the Center for Disease Control and Prevention (CDC).
    • “Cases of gonorrhea have grown roughly sevenfold since 2010 among American adults older than 55, per the data.
    • “Meanwhile, the CDC numbers also show cases of chlamydia have more than quadrupled since 2010 among the same age group and syphilis cases in 2022 were nearly eight times higher.  
    • “Some researchers think STD rates are climbing in this age group because older adults are having more sex than in years past, according to reporting from The Washington Post. 
    • “On top of this, older adults rarely use protection, which increases the odds of spreading disease, according to a 2023 study published in peer-reviewed medical journal The Lancet. 
    • “This generation rarely considers using protection because they came of age at a time when sex education in school did not exist, HIV was virtually unheard of, and their main concern in seeking protection was to avoid pregnancy,” Janie Steckenrider, associate professor of political science at Loyola Marymount University and lead author of the study, writes.”
  • The Wall Street Journal reports,
    • “A person in Texas tested positive for avian influenza after exposure to dairy cattle presumed to be infected with the H5N1 bird flu, the Centers for Disease Control and Prevention said Monday. 
    • “The case marks the second known instance that a person in the U.S. has been infected with H5N1 bird flu. The person reported eye redness, or conjunctivitis, as their only symptom and is being treated with an antiviral drug. The human health risk of the bird flu remains low for the U.S. general public, the CDC said, but people with close, prolonged exposures to infected animals or their environments are at higher risk. 
    • “At this point, there’s nothing that suggests that there is any serious risk of a larger human outbreak,” said Dr. Tom Inglesby, director of the Johns Hopkins Center for Health Security. “I’m trying to understand why the cows are getting infected. That’s a really important scientific question right now.”
  • Health Day lets us know,
    • “U.S. rates of suicide by all methods rose steadily for adolescents between 1999 and 2020, a new analysis shows.
    • “During those two decades, over 47,000 Americans between the ages 10 and 19 lost their lives to suicide, the report found, and there have been sharp increases year by year. 
    • “Girls and minority adolescents have charted especially steep increases in suicides, said a team led by Cameron Ormiston, of the U.S. National Institute on Minority Health and Health Disparities.
    • “An overall increasing trend was observed across all demographics,” the researchers wrote in a study published March 29 in the journal JAMA Network Open.”
  • and
    • “There are sociodemographic disparities in human papillomavirus (HPV) vaccine uptake among 27- to 45-year-olds, according to a study published online March 28 in Human Vaccines & Immunotherapeutics.
    • “Natalie L. Rincon, from Duke University in Durham, North Carolina, and colleagues explored any sociodemographic disparities in HPV vaccine uptake among 27- to 45-year-olds using data from the 2019 National Health Interview Survey (9,440 participants).
    • “The researchers found that women had more than three times greater odds of vaccine uptake versus men (adjusted odds ratio [aOR], 3.58). Non-Hispanic Blacks were more likely (aOR, 1.36) and Hispanics were less likely (aOR, 0.73) to receive the vaccine, compared with non-Hispanic Whites. Lower odds of uptake were seen among individuals without a usual place of care (aOR, 0.72) and in those with lower educational levels (highs school: aOR, 0.62; some college: aOR, 0.83).
    • “Males are in particular need of increased knowledge of the vaccine. For oropharyngeal cancer, about 75 percent of new cases are in males,” lead author Nosayaba Osazuwa-Peters, M.D., also of Duke University, said in a statement. “As oral HPV is the primary cause of HPV-associated oropharyngeal cancer, providing the HPV vaccine to middle-aged individuals is undoubtedly an important strategy to decreasing risk of infection, persistence, and eventual HPV-associated oropharyngeal malignancy.”
  • MedPage Today notes,
    • “Dropping pack-years for lung cancer screening eligibility in favor of a simpler 20-year history of smoking could substantially increase the number of cancers detected and eliminate racial disparities as well, according to an analysis of smokers from two large cohort studies.
    • “Under current screening criteria from the U.S. Preventive Services Task Force (USPSTF), which call for a 20-pack-year history of smoking, researchers found that 58% of Black patients with lung cancer in the Southern Community Cohort Study (SCCS) would have been eligible for screening, compared with 74% of white patients with lung cancer in SCCS.
    • “But these percentages would increase to 85.3% and 82%, respectively, with the proposed 20-year duration of smoking criteria, “thus eliminating the racial disparity in screening eligibility,” reported Chi-Fu Jeffrey Yang, MD, of Massachusetts General Hospital in Boston, and colleagues in the Journal of Clinical Oncologyopens in a new tab or window.
    • “Additionally, an analysis of the Black Women’s Health Study (BWHS) showed a switch to the simpler requirement would have increased the percentage of Black women who qualified for screening from 43% to 64%.”
  • The Wall Street Journal relates,
    • “Behind the blockbuster success of drugs like Ozempic and Wegovy is a less-noticed phenomenon: Some people don’t lose much weight on them.
    • “There is wide variation in weight loss on these types of drugs, called GLP-1s. Doctors say roughly 10% to 15% of people who try them are “non-responders,” typically defined as those who lose less than 5% of their body weight. These patients, doctors say, don’t experience enough appetite reduction to result in significant weight loss.
    • “Researchers are studying why some people drop a lot of weight on them while others lose little. The answers might yield broader clues about weight loss and provide more insight into these medications, which have transformed the way Americans lose weight.
    • “Doctors believe some people might be resistant to the drugs as a result of genetic differences. Other possible reasons could include certain medical conditions and medications, how much weight a person lost before taking the drugs, and differences in how people metabolize them.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “The net prices that health plans paid for medicines — after subtracting rebates, discounts, and fees — fell by 2.8% in last year’s fourth quarter, the largest decline ever measured by SSR Health, a research firm that tracks the pharmaceutical industry and its pricing trends.
    • “A key reason for the big drop — which dwarfed the 0.4% decline seen at the same time a year earlier — was pricing pressure on the Humira treatment for rheumatoid arthritis and psoriasis. Over the past year, nine biosimilar versions of the medicine were launched by other companies seeking favorable placement on formularies, the lists of drugs for which health insurance coverage is available.
    • “As these companies battled to win placement, the Humira net price fell to roughly $29,800 at the end of last year from $48,000 at the end of 2022, a nearly 38% drop, the SSR analysis found. In fact, the entire category of rheumatoid arthritis medicines saw a 30% decline in annual net pricing, the largest such drop among all type of drugs. Meanwhile, net prices for psoriasis treatments fell nearly 10%. * * *
    • There were net price gains in two categories, however, which helped offset the declines elsewhere at the end of 2023. Notably, there was a 15.4% net price increase for GLP-1 medicines, which are used to treat diabetes and obesity. This group includes Wegovy and Ozempic, which are sold by Novo Nordisk, and Mounjaro and Zepbound, which are sold by Eli Lilly.
  • Beckers Hospital Review points out ten drugs now in shortage in the U.S.
  • The Wall Street Journal reports,
    • “Mental-health urgent-care sites are proliferating across the U.S. to treat the spiraling numbers of children and adults who need mental-health care and ease a shortage of therapists that has caused many people to wait months for appointments or go to the nearest emergency room to find help.
    • “The sites are starting to change the face of mental-health treatment, offering a much-needed alternative to emergency departments—long the first point of contact for people in mental-health straits—that have become strained by an increase in visits during the pandemic. 
    • “More than 20 mental-health urgent-care centers have opened in the past year alone from Colorado to Virginia. A letter published in the journal Psychiatric Services in 2021 identified 77 of the clinics across the U.S.”
    • “The sites can provide therapy and prescribe drugs or refer patients to a higher level of care if needed, said Katherine Du, a University of Pittsburgh School of Medicine student who was lead author on the letter. Some are run by hospitals, while others were established by private-equity firms. Many are in wealthy areas, but most accept Medicaid. 
    • “We want to get upstream to prevent the crisis,” said Dr. Aliya Jones, executive medical director of behavioral health at the Luminis Health Behavioral Health Urgent Walk-In Clinic in Lanham, Md., which opened in August 2022 and serves ages 4 and older.”
  • BioPharma Dive notes,
    • “The Food and Drug Administration has approved a first-of-its-kind drug for people with the rare and serious blood disease paroxysmal nocturnal hemoglobinuria, or PNH.
    • “Called Voydeya and owned by AstraZeneca, the drug is cleared for use as an add-on therapy to the standard PNH treatments, Ultomiris and Soliris, the pharmaceutical company already sells. It’s meant for the estimated 10% to 20% of people with PNH who still experience significant “hemolysis,” or premature destruction of red blood cells, despite treatment with those other drugs.
    • “The approval builds up a business AstraZeneca inherited when it bought Alexion Pharmaceutical for $39 billion in 2020. That deal established AstraZeneca as a player in rare disease research due to Ultomiris and Soliris, which are each approved for PNH as well as other conditions. The two drugs are among AstraZeneca’s top-selling products, generating more than $6 billion in combined sales in 2023.
    • “Alexion also had drugs in its pipeline, such as Voydeya, that were meant to defend against rising competition from companies like Novartis, Roche and Amgen. The company had acquired Voydeya, previously known as danicopan, when it bought Achillion Pharmaceuticals for nearly $1 billion in 2019.”

Monday Roundup

David Ermer–Cybersecurity, Federal employment benefits, Medicare, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • STAT News reminds us,
    • “The public will soon find out whether the federal government is willing to meet the health insurance industry’s demands and deposit more money into the bank accounts of next year’s Medicare Advantage plans.
    • “Budget officials within the Biden administration started reviewing final payment regulations for 2025 Medicare Advantage plans last week after more than 42,000 public comments rolled into the federal government’s inbox. Those rules will come out no later than April 1.
  • Becker’s Hospital CFO Report adds,
    • “Onerous” authorization requirements and high denial rates have health systems considering whether to drop Medicare Advantage plans, according to a report from the Healthcare Financial Management Association and Eliciting Insights. 
    • “HFMA Health System CFO Pain Points Study 2024” is based on a survey of 135 health system CFOs conducted in January. 
    • According to the report, 16% of health systems are planning to stop accepting one or more Medicare Advantage plans in the next two years. Another 45% said they are considering the same but have not made a final decision.
    • Health systems have been increasingly pushing back on Medicare Advantage. Chris Van Gorder, president and CEO of San Diego-based Scripps Health, told Becker’s last year that “it’s becoming a game of delay, deny and not pay.” Scripps terminated Medicare Advantage contracts effective Jan. 1 for its integrated medical groups. The medical groups, Scripps Clinic and Scripps Coastal, employ more than 1,000 physicians, including advanced practitioners. Mr. Van Gorder said the health system was facing an annual loss of $75 million on MA contracts.  
    • “Providers are going to have to get out of full-risk capitation because it just doesn’t work — we’re the bottom of the food chain, and the food chain is not being fed,” he said.
    • Despite tensions with some health systems, the Medicare Advantage program had a 95% quality satisfaction rating among enrolled members in 2023.
  • The FEHBlog notes that MA plans are subject to the Affordable Care Act’s medical loss ratio. The medical loss ration encourages health plans to make payments to providers.
  • FedSmith lets us know,
    • The Federal Salary Council (FSC) recently proposed adding about 15,000 federal employees to existing locality pay areas for 2025 from the “Rest of the U.S.” Being added to a locality pay area usually results in higher pay for impacted employees.
    • FSC is recommending the Pay Agent add Wyandot County, OH, to the Columbus, OH, locality pay area and Yuma County, AZ, to the Phoenix, AZ, locality pay area. These recommendations do not create new locality pay areas. In this case, they are adding employees to existing pay areas using various techniques to reduce employees in the “Rest of the U.S.” and add more to higher-paying locality pay areas.
    • A proposal from the Federal Salary Council does not mean a decision to make these additions is finalized. The recommendations have to be approved by the President’s Pay Agent. That approval usually follows, although not necessarily in the recommended time frame. Once the Pay Agent decides to move ahead, the Office of Personnel Management has to issue a proposed change in the Federal Register and a final decision in the Federal Register a few months later.
  • Reg Jones, writing in Fedweek, discusses “Survivor Annuity Benefits for Children of Deceased Federal Employees and Retirees.”
  • KFF discusses Medicare spending on GLP-1 drugs, like Ozempic, to treat diabetes.
    • “Gross spending on Ozempic alone increased from $2.6 billion in 2021 to $4.6 billion in 2022, pushing it to 6th place among the top-selling drugs in Medicare Part D that year, up from 10th place the year before.  
    • “The fact that covering GLP-1s under Medicare Part D for authorized uses is already making a mark on total Part D program spending could be a sign of even higher spending to come as Part D plans are now able to cover Wegovy for its heart health benefits, and if new uses for GLP-1s are approved.”
  • CNBC adds,
    • “Americans can’t seem to get enough of weight loss drugs despite their limited insurance coverage and roughly $1,000 monthly price tags before discounts. 
    • “But some patients are willing to pay more out of pocket for those treatments than others — and it’s strongly correlated to their annual income.
    • “That’s according to a recent survey from Evercore ISI that focused on GLP-1s, which include Novo Nordisk’s weight loss injection Wegovy and diabetes counterpart Ozempic.

From the public health and medical research front,

  • The American Medical Association advises its members about measles, now at 64 cases, and tells patient what doctors wish they knew about vasectomies.
  • Medscape shares five things to know about Adult Respiratory Syncytial Virus (RSV) Infection.
  • The Washington Post features a Consumer Reports article on maintaining kidney health. “Hydration and exercise are just two of the keys to reducing the risk of kidney disease.”
  • The Society for Human Resource Management offers nine mental health questions for employee engagement surveys.
  • CNN reports,
    • “Drugmaker Eli Lilly warned this week that two of its formulations of insulin would be temporarily out of stock through the beginning of April, citing a “brief delay in manufacturing.”
    • “The 10-milliliter vials of Humalog and insulin lispro injection will be in short supply at wholesalers and some pharmacies, Lilly said in a statement posted online Wednesday [March 20]. The company said that prefilled pen versions of those medicines are still available in the US and that it continues to manufacture the 10-milliliter vials “and will ship them as soon as we can.”

From the U.S. healthcare business front,

  • The Wall Street Journal relates,
    • “Hospitals are adding billions of dollars in facility fees to medical bills for routine care in outpatient centers they own. Once an annoyance, the fees are now pervasive, and in some places they are becoming nearly impossible to avoid, data compiled for The Wall Street Journal show. The fees are spreading as hospitals press on with acquisitions, snapping up medical groups and tacking on the additional charges. 
    • “The fees raise prices by hundreds of dollars for widely used and standard medical care, including colonoscopies, mammograms and heart screening. 
    •  “Hospitals say facility fees help offset the extra costs that they incur to meet federal regulations. “It’s not as simple as same services, across-the-board,” said Jason Kleinman, director of federal relations for the American Hospital Association.” * * *
    • “Lawmakers and Congress have proposed limiting fees covered by Medicare, which advisers to the federal insurer have unanimously recommended. Under a bill passed by the House in December, Medicare would no longer pay hospital facility fees for chemotherapy and other drugs infused by doctors in clinics off a hospital campus, saving about $3.7 billion over 10 years. 
    • “The American Hospital Association opposes limiting the fees, saying restrictions would cut revenue to hospitals already squeezed financially by high labor costs and inflation.”   
  • Beckers Hospital CFO Report adds,
    • “Kaufman Hall’s latest “National Hospital Flash Report,” which is based on data from more than 1,300 hospitals, outlined three key areas that separate high-performing hospitals’ and low-performing hospitals when it comes to their operating performances: 
      • “Outpatient revenue. In general, hospitals with higher and accelerating outpatient revenue are more profitable.
      • “Contract labor. Hospitals that quickly reduced their percentage of contract labor demonstrate improved operating profitability. In addition, hospitals that aggressively marched down contract labor costs were correlated to rising wage rates for full-time staff. Rising wage rates appeared to attract and retain full-time staff, which has allowed those hospitals to decrease contract labor more quickly, all of which has led to increased profitability, according to the report. 
      • “Average length of stay. A lower average length of stay corresponded with improved profitability. Hospitals that hyper-focused on patient throughput — which has led to appropriate and prompt patient discharge — have also proven this to be a solid financial strategy, according to the report.”
    • “Hospitals on the other end of the scale continue to struggle, with the poorest financially performing hospitals reporting negative margins from -4% to -19%, according to Kaufman Hall. Continuation of this level of performance is unsustainable and makes it impossible to reinvestment in community care.” 
  • Per BioPharma Dive,
    • “Novo Nordisk will pay as much as $1 billion to acquire RNA drug developer Cardior and its experimental treatment for heart failure, the companies announced Monday. 
    • “Cardior’s treatment, dubbed CDR132L, is currently being tested in a mid-stage study involving 280 people with heart failure who previously experienced a heart attack. Results are expected by September, according to a U.S. clinical trial database.
    • “In addition to that study, Novo said it plans to start another Phase 2 trial in heart failure patients whose heart muscle has become thick and stiff, also known as cardiac hypertrophy. Novo, which will pay an undisclosed upfront payment to Cardior per deal terms, expects the acquisition to close in the second quarter.”
  • and
    • “Abbvie is expanding its pipeline of inflammatory disease drugs, announcing Monday a small deal to acquire biotechnology company Landos Biopharma.
    • “Per the deal, Abbvie will buy Landos for $20.42 per share, or about $138 million. Abbvie has also agreed to pay a so-called contingent value right worth $11.14 per share, or another $75 million, if certain milestones are met. The upfront price represents a premium of about 155% to the closing price Friday of Landos stock.
    • “Landos is currently running a mid-stage trial of its lead drug, dubbed NX-13, in ulcerative colitis. Abbvie is also interested in NX-13’s potential in Crohn’s disease.”
  • Per Healthcare Dive,
    • “Change Healthcare said its largest claims clearinghouses would come back online over the weekend, more than a month after a cyberattack at the technology firm disrupted the healthcare sector. 
    • “More than $14 billion in charges have been prepared for processing, according to an update from parent company UnitedHealth Group on Friday. Change’s electronic payments platform has also been restored, and the company is working on payer implementations.”

Weekend Update

David Ermer–Congress, Generative AI, Medical / Rx research, Mental health care, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Govexec tells us,
    • “The Senate approved a $1.2 trillion spending package early Saturday shortly after a portion of the government was set to shut down, staving off the threat for the remainder of fiscal 2024. 
    • “The upper chamber moved to approve the measure after funding had lapsed, though shutdown procedures never commenced because an agreement was imminent. President Biden’s was expected to quickly sign the measure, which the House passed on Friday. The spending bill includes funding for the remaining parts of government that have not yet received full-year appropriations, including the departments of Defense, Treasury, Homeland Security, Labor, Health and Human Services, Education and State. 
  • Federal News Network notes,
    • “Congress is looking for details on federal telework as part of the latest government spending agreement — echoing months of return-to-office scrutiny from the House Oversight and Accountability committee.
    • “Among its many provisions, the agreement congressional appropriators reached Thursday for the back half of fiscal 2024 government spending bills lays out six new requirements on federal telework and return-to-office for federal employees.
    • “Within 90 days of the legislation’s enactment, the Office of Management and Budget will have to turn over all agencies’ return-to-office “action plans” outlined earlier this year, lawmakers said in an explanatory statement for the 2024 Financial Services and General Government bill.”
  • The House of Representatives and the Senate are on a two week long break. For those who are interested in an inside baseball approach, the Wall Street Journal examines the coalition government operating in the House of Representatives. Of course, the Democrats have a narrow majority in the Senate. All of that may change as a result of November’s national election.
  • OPM’s FEHB carrier conference will be held on Wednesday and Thursday this week.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Catherine, Princess of Wales, who Friday announced a cancer diagnosis, said she is getting preventative chemotherapy—a treatment that is given after surgery in hopes that it will increase the odds of a cure. 
    • “That the princess is undergoing preventative chemotherapy “suggests to me this is a curable cancer,” said Dr. Angela Jain, an assistant professor in the department of hematology and oncology at Fox Chase Cancer Center in Philadelphia. Jain and other doctors who spoke with The Wall Street Journal aren’t involved in Catherine’s care.
    • “Such chemotherapy, which oncologists call “adjuvant” therapy, is routinely given after surgical removal of a tumor for several months or for as long as a year, Jain said. Patients often get the treatment every two or three weeks. It doesn’t always stop the cancer from returning, but it can increase the odds of eliminating the disease.
    • “Not all cancers need chemo after surgery, but some do,” she said. “And usually you give that treatment with the hope and intention that this is a curable cancer, and chemo will reduce the risk of it coming back.” 
  • The Washington Post adds,
    • “In a recent panel at SXSW in Austin earlier this month, [Katie] Couric spoke about the rise in colorectal cancer. In particular, she hopes women better understand their risks. The risk of developing colorectal cancer is 1 in 23 for men and 1 in 25 for women, according to the American Cancer Society.  
    • “Women, especially younger women, believe this is an old man’s disease, and that’s simply not true,” she says. “Women are diagnosed with colorectal cancer as often as men. I think sometimes people get colons and prostates confused.”
    • “Less than half—44%—of Gen X women have gotten screened for colon cancer, and yet, “they are right in the sweet spot,” Couric says. And 43% of young women believe colon cancer is a men’s disease, of which nearly half think men are impacted two to three times as much as women, which is not correct, according to Medtronic, a health care technology company implementing AI in screening protocols.”  
  • and
    • “The Cancer Detectives,” a new American Experience documentary on PBS, tracks the fascinating and surprisingly frustrating backstory of the Pap smear, a cervical cancer screening test that’s now routine but was once anything but.
    • “The film takes viewers back to the days before Pap smears, a time when cervical cancer was rightfully feared by patients and doctors alike. A century ago, cervical cancer was a major killer of women. Early detection was impossible, and sexual stigma and shame kept women from discussing it.
    • “So it’s not surprising that when an immigrant physician from Greece, George Papanicolaou, nicknamed “Dr. Pap,” discovered a way to detect changes in cervical cells, his breakthrough was largely disregarded by the scientific community.
    • “It would take a massive public relations war against the unspeakable cancer to make the Pap smear a routine part of cervical cancer screening — a war waged in part by Black OB/GYN Helen Dickens, Japanese American illustrator Hashime Murayama and a group of women committed to cancer prevention.”
  • Fortune Well offers tips on how to stay in shape in your thirties, forties, and fifties. Gook luck.
  • The New York Times informs us,
    • “Most people, study after study shows, don’t take the medicines prescribed for them. It doesn’t matter what they are — statins, high blood pressure drugs, drugs to lower blood sugar, asthma drugs. Either patients never start taking them, or they stop.
    • “It’s a problem that doctors call nonadherence — the common human tendency to resist medical treatment — and it leads to countless deaths and billions of dollars of preventable medical costs each year.
    • “But that resistance may be overcome by the blockbuster obesity drugs Wegovy and Zepbound, which have astounded the world with the way they help people lose weight and keep it off. Though it’s still early days, and there is a paucity of data on compliance with the new drugs, doctors say they are noticing another astounding effect: Patients seem to take them faithfully, week in and week out.”
  • Per mHealth Intelligence,
    • “Using telehealth to provide palliative care support to rural family caregivers is a low-cost and feasible strategy for transitioning patients from hospital to home-based care, new research reveals.
    • “Conducted by researchers from the Mayo Clinic, Duke University, and the Minneapolis Veterans Affairs Health Care System, the study examines a telehealth-based palliative care support program for rural family caregivers who face challenges in accessing coordinated care for their loved ones during and after hospitalization. It also evaluated resource use, health system costs, and Medicare reimbursement pathways for this approach. Results were published in the American Journal of Hospice and Palliative Medicine.”
  • The MIT Technology News points out,
    • “Alex Zhavoronkov has been messing around with artificial intelligence for more than a decade. In 2016, the programmer and physicist was using AI to rank people by looks and sort through pictures of cats.
    • “Now he says his company, Insilico Medicine, has created the first “true AI drug” that’s advanced to a test of whether it can cure a fatal lung condition in humans. 
    • “Zhavoronkov says his drug is special because AI software not only helped decide what target inside a cell to interact with, but also what the drug’s chemical structure should be.”
  • From the Wall Street Journal,
    • “Elon Musk’s Neuralink introduced the first patient to receive its brain-computer implant, a 29-year-old diving-accident victim who showed during a livestream that he can now move a computer cursor using the device.
    • “In a nine-minute presentation streamed on Musk’s X platform Wednesday, Neuralink showed Noland Arbaugh directing the cursor around a screen to play a game of chess. Arbaugh said it feels like “using the force on a cursor,” referring to a concept from movies such as “Star Wars.” He said his surgery went well and he left the hospital after one day.
    • “Moving a computer cursor isn’t a big technical leap for brain-computer interfaces. An older brain chip first implanted in a human in 2004 also helped a paralyzed person move a cursor with only their thoughts. But the older chip must be attached to a device on the outside of the brain to transmit data, requiring wires protruding through the skin.
    • “Neuralink’s device transmits data wirelessly, and it can be used at home, outside of a laboratory setting.
    • “Another notable feature of Neuralink’s presentation was that Arbaugh was multitasking: playing chess while speaking about his experience getting the implant. Prior demonstrations of brain-computer interfaces have required dedicated attention to a particular task.”
  • and
    • “The more time you spend alone, the more likely you are to be lonely, right?
    • “Seems obvious. But it isn’t always true, according to a new study. For instance, it found that although, in general, those who spend the most time alone are the loneliest, that isn’t the case for young people; their time alone has little impact on how lonely they feel. What’s more, people who spend the least time alone tend to be slightly lonelier than those between the extremes. * * *
    • “Relationship status also was significant. Single people tended to spend more time alone than those in relationships and reported greater loneliness. Gender wasn’t a significant predictor of loneliness, the study found.
    • “The bottom line is that loneliness can’t simply be measured by the degree of a person’s social interaction.
    • “The degree of loneliness a person experiences is influenced by how much social interactions they have and by how much social interactions they feel they need,” Mehl says. “Beyond that, an important determinant of feelings of loneliness is the perceived meaning that a person derives from the social interactions they have.”

Friday Factoids

David Ermer–ACA, CDC, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, Mental health care, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “House lawmakers approved a $1.2 trillion package of spending bills Friday over significant Republican opposition in the GOP-led chamber—sending the bill to the Senate, where lawmakers were working to pass the measure by a midnight deadline to avoid a partial government shutdown.
    • “The House vote was 286 to 134, barely exceeding the two-thirds supermajority needed to approve the bill under a special procedure needed by House Speaker Mike Johnson (R., La.) to bypass internal GOP divisions in his razor-thin majority.” * * *
    • “With the House done with the measure, Senate Majority Leader Chuck Schumer(D., N.Y.) took steps to begin the process of considering the bills. This typically takes several days, but could happen within hours if all 100 senators agree to a quicker voting timeline. Funding is scheduled to run out for the Defense Department and several other agencies at 12:01 a.m. on Saturday, which would force them to shut down nonessential operations.
    • “President Biden has said he would sign the legislation.”
  • Beckers Payer Issues informs us,
    • “A group of Republican lawmakers are asking CMS to reconsider its proposed 2025 rates for Medicare Advantage. 
    • “Forty-five lawmakers signed a letter to CMS Administrator Chiquita Brooks-LaSure expressing concerns the proposed rates could lead health plans to cut benefits for older adults and harm the viability of the program. 
    • “It is baffling that CMS has proposed a nearly 0.2% cut to the Medicare Advantage insurer reimbursement rate for 2025,” the lawmakers wrote. 
    • “CMS proposed cutting benchmark payments for Medicare Advantage plans by 0.2% in 2025. The agency says plans should expect to see 3.7% higher revenue overall, with an MA risk score trend of 3.86% — the average increase in risk adjustment payments year over year — offsetting risk model revisions and a projected decline in star rating bonuses. 
    • “The insurance industry has decried the rate notice, calling it insufficient to cover rising medical costs among MA beneficiaries. Some insurers have said they will likely cut supplemental benefits for beneficiaries to offset decreasing benchmark payments.” 
  • The Centers for Medicare and Medicaid Services announced,
    • “Today, the U.S. Department of Health and Human Services (HHS) issued four new reports showing that President Biden’s efforts to strengthen the Affordable Care Act (ACA) are linked to historic gains in Americans’ health insurance coverage. Today’s announcements include a report from the Centers for Medicare & Medicaid Services (CMS) showing that over 21 million consumers selected or were automatically re-enrolled in health insurance coverage through HealthCare.gov and State-based Marketplaces during 2024’s Open Enrollment Period (OEP). Three reports from HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) highlight current enrollment trends, enrollment trends broken down by race and ethnicity, and how the ACA Marketplaces have evolved and strengthened during the first ten years. ASPE analysis shows that today over 45 million people have coverage thanks to the Affordable Care Act’s Marketplaces and Medicaid expansion.” 
    • People buy it because of the low price but do they use it effectively?

From the public health and medical research front,

  • The Centers for Disease Control inform us
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare remains elevated nationally but is decreasing across many areas of the country. This week, 9 jurisdictions experienced high or very high activity compared to 17 jurisdictions the previous week.
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week.
    • “Nationally, COVID-19 wastewater viral activity levels, which reflects both symptomatic and asymptomatic infections, is low.
    • “Reported on Friday, March 22nd, 2024.”
  • The New York Times considers “What’s Next for the Coronavirus? Scientists studying the virus’s continuing evolution, and the body’s immune responses, hope to head off a resurgence and to better understand long Covid.”
    • “We’re not in the acute phases of a pandemic anymore, and I think it’s understandable and probably a good thing” that most people, including scientists, have returned to their prepandemic lives, said Jesse Bloom, an evolutionary biologist at the Fred Hutchinson Cancer Center in Seattle.
    • “That said, the virus is still evolving, it’s still infecting large numbers of people,” he added. “We need to keep tracking this.”
  • That’s a reassuring statement.
  • The Wall Street Journal tells us,
    • “Grief is well recognized as a process people go through after losing a loved one. But less attention is paid to the grief of people with chronic illnesses and disabilities for the losses they’ve suffered. 
    • “The grief of those with chronic health issues—for the loss of capabilities, for changed or ruptured relationships, for changes in appearance, for the forced end of a career, or for former dreams for the future—can last for long periods and recur often, as losses and uncertainty become a constant feature of life.
    • “What’s the next thing that [my conditions are] going to take from me?” asks Andrew Gurza, a disability-awareness consultant who has cerebral palsy and chronic illness. “What’s the next thing that I’m not able to do anymore?”
    • “People who have intimate knowledge of the grief that comes with chronic health issues say it has a trajectory all its own—a trajectory that many mental-health professionals, friends and family often don’t understand. The idea that everyone goes through five stages of grief—denial, anger, bargaining, depression and acceptance—doesn’t ring true for many disabled people. Chronic illness, other disabilities and the grief they bring often run an unpredictable course, easing but then flaring up again, a cycle that can recur over time. * * *
    • “Mel Sebastiani, an end-of-life doula and former chaplain who is seeking diagnosis for her own neurological illness, says that with her clients, she emphasizes “deep listening and finding out what that person likes, misses—and [finding] a way to weave it back into their lives in a way that they can manage.” 
    • “For Sebastiani herself, that meant coping with new symptoms by switching from steep mountain-trail hikes to walks on the beach to collect and photograph sea glass and other natural treasures near her home in Rehoboth Beach, Del.  
    • “While grief will persist, it may not always be a negative or debilitating experience. “You can be in grief and be a strong person,” Sebastiani says.
    • “Grief is a powerful tool and coping mechanism to realize where you are in the moment, where your life is a reflection on your life in the past,” she says. “And it’s kind of a gift in that sense, because many healthy people never reflect on any of that.”
  • The International End of Life Doula Association discusses their profession.
    • “A doula can become involved any time in a person’s life. We offer support when people are impacted by a life changing illness, after a terminal diagnosis, when death is imminent, or even after a death—to help with light grief support. Sometimes family members or loved ones of the person dying seek support and guidance from end-of-life doulas.
    • “Doulas normalize deathcare by creating spaces to hold conversations leading to increased communication and increased spiritual and emotional well being. When individuals plan for death, they have autonomy over their decisions and are able to clearly define their end-of-life wishes with family and loved ones. While there are alternative names for end-of-life doulas like death doula, death midwife, death coach, end-of-life coach—we all seek to provide compassionate deathcare.”
  • Medscape lets us know,
    • “Use of statin drugs was associated with improved mortality in older nursing home residents, regardless of dementia status, a new study showed.
    • “The study is among the first to explore whether statin use in older nursing home residents offers a mortality benefit, especially among individuals with dementia, a group largely excluded from earlier statin trials.
    • “Investigators’ analysis of 4 years of data on nearly 300,000 nursing home residents revealed that statin use was associated with a 40% lower risk for all-cause mortality than statin nonuse in those without dementia and a 20% lower risk in those with dementia.
    • “These findings may provide evidence that supports the continued use of statins in older nursing home patients with multiple medical conditions,” lead author Julie Lorraine O’Sullivan, PhD, of the Charité – Universitatsmedizin Berlin, Freie Universität Berlin, German Center for Mental Health, Berlin, Germany, and colleagues wrote.
    • “The study was published online on February 27 in Neurology.”
  • and
    • “A new way of using artificial intelligence (AI) can predict breast cancer five years in advance with impressive accuracy — and unlike previous AI models, we know how this one works.
    • “The new AI system, called AsymMirai, simplifies previous models by solely comparing differences between right and left breasts to predict risk. It could potentially save lives, prevent unnecessary testing, and save the healthcare system money, its creators say.
    • “With traditional AI, you ask it a question and it spits out an answer, but no one really knows how it makes its decisions. It’s a black box,” said Jon Donnelly, a PhD student in the Department of Computer Science at Duke University, Durham, North Carolina, and first author on a new paper in Radiology describing the model.
    • “With our approach, people know how the algorithm comes up with its output so they can fact-check it and trust it,” he said.”
  • mHealth Intelligence relates,
    • “Direct-to-consumer (DTC) telehealth visits resulted in higher rates of antibiotic prescriptions for pediatric patients than telehealth visits conducted by primary care physicians (PCPs), according to a new study by UPMC.
    • “Published in JAMA Open Network, the study aimed to assess antibiotic prescriptions for pediatric acute respiratory tract infections during telehealth visits with PCPs compared with virtual visits conducted by commercial DTC telehealth companies.
    • “High rates of antibiotic prescriptions raise concerns about antibiotic resistance, which occurs when germs develop the ability to defeat the drugs designed to kill them. Antibiotic-resistant infections can be challenging to treat, often requiring second- and third-line treatments that can have harmful side effects. In some cases, these infections have no treatment options.”

From the Food and Drug Administration (FDA) front,

  • Per an FDA press release,
    • “Today, the FDA issued an emergency use authorization for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kilograms [about 88 pounds]). 
      Pemgarda is authorized for individuals:
      • “who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2; 
      • “and who have moderate-to-severe immune compromise due to a medical condition or due to taking immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. 
    • “For more information about Pemgarda and its authorization, please see the resources available on the FDA’s Emergency Use Authorization webpage.”
  • Per Medpage Today,
    • “The FDA approved label expansions for bempedoic acid (Nexletol) and bempedoic acid/ezetimibe (Nexlizet) so they can be used more broadly as cardiovascular prevention drugs, Esperion announced Fridayopens in a new tab or window.
    • “Based on the CLEAR Outcomes trialopens in a new tab or window, the two adenosine triphosphate (ATP) citrate lyase inhibitor drugs are now indicated for adults with either established atherosclerotic cardiovascular disease (CVD) or high risk for a CVD event to reduce the risk of myocardial infarction (MI) and coronary revascularization. Approval does not require patients to be on existing statin therapy.”
  • Per MedTech Dive,
    • “The Food and Drug Administration’s plan to expand oversight of laboratory-developed tests threatens to prevent or delay patient access to innovative diagnostics, industry groups warned in congressional testimony Thursday.
    • “The FDA’s final rule on LDT regulation, which could come as soon as April, has unleashed a fierce debate over how to protect the health and safety of patients by ensuring tests developed in a single laboratory are accurate and reliable but still reach the market quickly. The agency received nearly 7,000 comments on the proposed rule, which would broaden its authority to regulate the tests.
    • “Laboratory-developed tests really are the cutting edge when it comes to leading the foundational work for personalized medicine,” Susan Van Meter, president of the American Clinical Laboratory Association, told a House Energy and Commerce health subcommittee hearing. The Clinical Laboratory Improvement Amendments program certifies LDTs under the current regulatory framework.”

From the U.S. healthcare business front,

  • Beckers Hospital Review points out,
    • Jellico (Tenn.) Regional Hospital, a 25-bed critical access facility, closed March 9, making it the 36th rural hospital to shutter or no longer provide inpatient services since 2020, according to data compiled by the University of North Carolina’s Cecil G. Sheps Center for Health Services Research. 
    • The closures highlight the heightened financial challenges that rural hospitals face amid persisting workforce shortages, rising costs and leveling reimbursement. In addition, only 45% of rural hospitals now offer labor and delivery services, and in 10 states, less than 33% do, according to the Center for Healthcare Quality and Payment Reform.
    • The article lists the rural hospitals that have closed.
  • Per Fierce Healthcare,
    • “Uncomfortable waiting rooms. Revealing hospital gowns. Confusing insurance. Exhausting travel between appointments.
    • “These are just some reasons cancer is in desperate need of a rebrand, experts said at this year’s SXSW conference.
    • “Oncology was a major focus across multiple sessions, where clinicians and patient advocates called for better access to specialty care, more thoughtful communication with patients and continued collaboration across stakeholders.”
  • Per HR Dive,
    • “Seventy-one percent of senior finance leaders plan to give raises of at least 4% in 2024, outpacing inflation in most areas, according to the results of a survey by Gartner, Inc., which were released March 20. The majority (58%) said they intended to raise compensation by between 4% and 9% this year. 
    • “Compensation ranked second among the areas where leaders said they planned to increase budgets this year, beaten only by technology investments, which were a priority for 82% of the 296 CFOs and senior finance leaders surveyed in December. However, fewer leaders intended to award raises of 10% or more, the survey found. 
    • “Even with tighter economic policy and pressure from boards and investors on profitable growth and employee productivity, CFOs are outpacing inflation that has now almost returned to a neutral rate below 3%,” Alexander Bant, chief of research in the Gartner finance practice, said in a statement. “The fact that most CFOs are planning for pay growth that exceeds the level of inflation indicates how tight the labor market is right now and how important it is to find and retain top talent.”
  • Mercer Consulting informs us,
    • “Gen Z is redefining the employer-employee relationship and that includes how voluntary benefits are structured and offered.  
    • “By 2025, Gen Z (those born 1997−2021) will comprise 27% of the workforce, and this group has far different expectations than their older peers. With voluntary benefits supporting all aspects of total rewards, the right solutions can help solve the most pressing talent questions — including how to resonate with the newbies in the workplace. Mercer’s latest National Survey of Employer-Sponsored Health Plans found that as employers have broadened the range of voluntary benefits offered, a growing portion of their workers are choosing to enroll in them – 45% of eligible employees on average, up sharply from 36% in 2022. * * *
    • “Gen Z respondents in the survey were more likely than older workers to say that benefits are a reason to stay with their employer. Designing the right benefits program is a way to partner with Gen Z on improving their physical, mental and emotional health and their financial well-being — and it shows that their employer is listening and cares about their holistic experience.”   
  • Per Healthcare Dive,
    • “Consumers are willing to share their health data, but they’re becoming pickier about which entities they’ll provide that information to, according to a survey from consultancy and digital health venture capital firm Rock Health. 
    • “Ninety percent of respondents said they’d share their data with at least one healthcare entity, the survey found. While 64% reported they’d offer data to a doctor or clinician, only 7% would share with a technology company.
    • “Consumers were also willing to share data with fewer entities in 2023 compared with 2020. The wariness is a warning for the sector, as data sharing is key to informing new treatments, studying disease trends and training healthcare artificial intelligence models, the report said.” 

Thursday Miscellany

David Ermer–AHRQ, CDC, CMS, Congress, Cybersecurity, Electronic health records, FDA, HSA, Medical / Rx research, Medicare, Mental health care, NCQA, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Lawmakers released a more than $1.2 trillion, six-bill appropriations package early Thursday morning, less than 48 hours ahead of a Friday night deadline for this second and final wrapup measure for the fiscal year that began Oct. 1. 
    • “Both parties were touting “wins” in the package well before unveiling the massive 1,012-page bill, which had already won President Joe Biden’s blessing and pledge to sign it “immediately.” That, plus the lure of a two-week recess, should help get the package over the finish line, though it seems likely to slip past the 11:59 p.m. Friday cutoff for the current stopgap spending law.
    • “But lawmakers weren’t really sweating the prospect of a weekend funding lapse, given its limited impact on government operations — especially with Friday’s expected House passage likely to be a strong signal of congressional intent to keep the lights on.”
  • The bill includes appropriations for OPM (pages 247 – 250) and its Inspector General (page 250) plus the three now standard appropriations measures:
    • A prohibition against imposing full Cost Accounting Standards coverage on FEHB carriers. Division B, Section 611, page 268.
    • The Hyde amendment limiting FEHB coverage of abortions to cases “where the life of the mother would be endangered if the fetus were carried to term, or the pregnancy is the result of an act of rape or incest.” Division B, Section 613 and 614, pages 268 – 269.
    • A contraceptive prescription drug coverage mandate with conscience protections for FEHB plans and healthcare providers. Division B, Section 726, page 298.
  • The American Hospital Association News discusses HHS appropriations, which also are included in this bill.
    • “The House may vote on the measure Friday, with Senate action expected over the weekend. A short government shutdown may occur over the weekend, depending how long it takes both chambers to pass the measure and for President Biden to sign it into law.” 
  • Govexec points out “the nine biggest agency and program reforms in the final FY24 spending package.”
  • The Wall Street Journal scoops,
    • “Some Medicare members could get help paying for the popular new weight-loss drug Wegovy—as long as they have a history of heart disease and are using it to prevent recurring heart attacks and strokes.
    • “Medicare Part D drug-benefit plans—which are administered by private insurers—may cover anti-obesity medications if the drugs receive approval for an additional use that is considered medically accepted under federal law, the Centers for Medicare and Medicaid Services told The Wall Street Journal on Thursday. * * *
    • “Some Medicare members could get help paying for the popular new weight-loss drug Wegovy—as long as they have a history of heart disease and are using it to prevent recurring heart attacks and strokes.
    • “Medicare Part D drug-benefit plans—which are administered by private insurers—may cover anti-obesity medications if the drugs receive approval for an additional use that is considered medically accepted under federal law, the Centers for Medicare and Medicaid Services told The Wall Street Journal on Thursday.”
  • STAT News adds,
    • “Early data regarding the use of GLP-1 medications like Ozempic and Wegovy to treat addiction is “very, very, exciting,” Nora Volkow, the director of the National Institute on Drug Abuse, said Thursday.
    • “But even as she expressed enthusiasm for the new drugs’ potential, Volkow criticized pharmaceutical companies for neglecting a moral imperative to develop new addiction treatments — but acknowledged that the health system more broadly doesn’t incentivize drug companies to treat the U.S. drug crisis with urgency.”
  • The U.S. Preventive Services Task Force finalized its research plan for re-evaluating its September 2019 recommendations on the topic of medications to reduce the risk of breast cancer.
  • Beckers Health IT interviews Alexandra Mugge, chief health informatics officer at CMS, about the agency’s efforts “to expedite prior authorizations, through digitization and better data exchange, saving the healthcare industry $15 billion over a decade — in the hopes of one day having the decisions made instantaneously, right in the EHR.”

From the Food and Drug Administration front,

  • Per a press release,
    • “Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. It is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle.
    • “DMD denies the opportunity for a healthy life to the children it affects. The FDA is committed to advancing the development of new therapies for DMD,” said Emily Freilich, M.D., director of the Division of Neurology 1, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This approval provides another treatment option to help reduce the burden of this progressive, devastating disease for individuals impacted by DMD regardless of genetic mutation.”
  • MedTech Dive informs us,
    • Johnson & Johnson subsidiary Abiomed recalled its Impella left sided blood pumps for risk that the devices could perforate the heart during a procedure. The recall began on Dec. 27 with Abiomed updating its instructions for use.
    • The Food and Drug Administration identified the recall as a Class I event, the most serious type of recall, in a Thursday notice. The agency has received 129 reports of serious injuries, including 49 deaths, related to the problem. 
    • Abiomed’s Impella heart pumps, which are used to support the heart during procedures or during cardiogenic shock, were the subject of four Class I recalls last year, including the latest recall. The company also received an FDA warning letter for quality problems with Impella and software used in the device that had not been authorized by the agency.

From the public health and medical research front,

  • The CDC shares with us,
    • Data from the National Vital Statistics System
      • Life expectancy for the U.S. population in 2022 was 77.5 years, an increase of 1.1 years from 2021.
      • The age-adjusted death rate decreased by 9.2% from 879.7 deaths per 100,000 standard population in 2021 to 798.8 in 2022.
      • Age-specific death rates increased from 2021 to 2022 for age groups 1–4 and 5–14 years and decreased for all age groups 15 years and older.
      • The 10 leading causes of death in 2022 remained the same as in 2021, although some causes changed ranks. Heart disease and cancer remained the top 2 leading causes in 2022.
      • The infant mortality rate was 560.4 infant deaths per 100,000 live births in 2022, an increase of 3.1% from the rate in 2021 (543.6).
  • STAT News adds,
    • “The U.S. recorded 107,941 drug overdose deaths in 2022, according to a new federal report — a total that marks an all-time record but also shows signs that the country’s overdose rate may finally be leveling off after years of steady increase.
    • “The 2022 total marks only a slight increase from the drug death toll of 106,699 the year before, according to the Centers for Disease Control and Prevention. The flattening of drug death rates could provide a rare glimmer of hope amid the bleak U.S. drug crisis, which has seen overdose rates rise inexorably for the past two decades and especially during the Covid-19 pandemic.
    • “A large majority of those deaths were driven by the potent synthetic opioid fentanyl. Since emerging in the drug supply in the mid-2010s, fentanyl has increasingly come to dominate the U.S. illicit drug market. Even as fentanyl deaths have skyrocketed, the share of deaths involving other opioids — like heroin, methadone, and prescription painkillers — has decreased.”
  • The Washington Post reports,
    • “After once losing hope because of end-stage kidney disease, a 62-year-old man is now the first living person to receive a genetically edited kidney from a pig, according to doctors at Massachusetts General Hospital who performed the landmark surgery Saturday.
    • “Richard Slayman, whom doctors praised for his courage, is doing well after the four-hour surgery and is expected to be discharged from the Boston hospital soon, officials said.
    • “The advance, which builds on decades of work, gives hope to the hundreds of thousands of Americans who depend on dialysis machines to do the work of their failing kidneys. Each day, 17 Americans die awaiting a kidney transplant, a problem further complicated by unequal access given to Black and other patients. Doctors expressed hope that using pigs to vastly increase the supply of kidneys might correct the inequity.”
  • The Wall Street Journal lets us know,
    • “A new class of anticoagulant drugs on the horizon is taking fresh aim at one of cardiology’s toughest challenges: how to prevent blood clots that cause heart attacks and strokes, without leaving patients at risk of bleeding.
    • “At least a half-dozen experimental blood thinners are in development that inhibit a protein called factor XI, one of several blood factors that regulate how the body forms clots. * * *
    • “Any factor XI agent that reaches the market would likely represent an important advance over drugs called factor Xa inhibitors, a blockbuster class of medicines dominated by Eliquis and Xarelto. Since they were approved just over a decade ago, these drugs have supplanted warfarin as the standard-of-care anticoagulant to prevent stroke in patients with the heart-rhythm disorder atrial fibrillation as well as other indications.”
  • HealthDay informs us,
    • “About 1 in every 10 U.S. children ages 5 to 17 has been diagnosed with attention deficit hyperactivity disorder (ADHD), according to the latest government statistics.
    • “The data from the National Health Interview Survey covers the years 2020 through 2022 and came from in-person or phone interviews involving a representative sample of American homes.
    • “It found that 11.3% of school-age children have been diagnosed with ADHD, with boys more likely to have this diagnosis (14.5%) than girls (8%), according to report authors Cynthia Reuben and Nazik Elgaddal, of the National Center for Health Statistics (NCHS).
    • “ADHD is diagnosed more often among white children (13.4%) than Black youngsters (10.8%) or Hispanic (8.9%) kids, the survey also showed. 
    • “Family income seemed to matter, too:  As income levels rose, the rate of child ADHD diagnoses declined.”
  • WTW, an actuarial consulting firm, offers insights on hepatitis C, HPV vaccine and value based insurance design.

From the U.S. healthcare business front,

  • STAT News reports,
    • “The last decade has seen billions of dollars flow into digital health companies that promise to improve outcomes for the 38 million Americans living with type 2 diabetes. Their products aren’t cheap, but in the long term, they pitch to health plans and employers that these digital tools will help cut health care costs by preventing serious complications like amputation and kidney failure.
    • “A systematic review by the Peterson Health Technology Institute found, though, that digital tools used to manage diabetes with the help of finger-stick blood glucose readings don’t result in clinically meaningful improvements over standard care. As a result, they don’t reduce health care spending — they drive it up.
    • “Most of the solutions in this category do not deliver clinical benefits that justify their cost,” Caroline Pearson, executive director of the institute, told STAT. Despite finding that some populations may benefit, the report concludes that current evidence doesn’t support broader adoption for most products.”
  • Plan Sponsor notes,
    • “In the face of rising health care expenditures and out-of-pocket spending, average health savings account balances have also steadily increased since the COVID-19 pandemic, according to new data from the Employee Benefit Research Institute.
    • “The average HSA balance rose to $4,418 at the end of 2022 from $2,711 at the start of the year, the most recent data available in EBRI’s database, given that participants can still contribute to 2023 HSAs until taxes are due in April.
    • “Jake Spiegel, a research associate at EBRI, says he sees this trend continuing in 2023 and into the start of 2024 as well.
    • “EBRI’s analysis revealed two predominant factors associated with higher average account balances. The first was that age is strongly associated with higher HSA balances: the older the accountholder, the higher the average balance.”
  • Beckers Hospital Review lets us know,
    • “Change Healthcare said it has reinstated Amazon cloud services for two of its platforms a month into a cyberattack against the company.
    • “The UnitedHealth Group and Optum subsidiary said March 20 it restored Amazon Web Services from backups for Assurance, a claims and remittance management program, and claims clearinghouse Relay Exchange. Change said it rebuilt authentication services for the solutions on a new network with the help of cybersecurity firms Palo Alto Networks and Mandiant, a Google subsidiary. The company said it is also testing the security of the external-facing parts of those applications.”
  • Per the Society for Human Resource Management,
    • “Employees are experiencing more mental health struggles and overall negative feelings about their work, underscoring an “urgent need” for employers to take more aggressive measures to help with their benefits offerings.
    • “Employees are now more likely to experience negative feelings at work, including stress (12 percent more likely) and burnout (17 percent more likely) than they were pre-pandemic (2019), according to new data from MetLife. Employees are also 51 percent more likely to feel depressed at work than they were pre-pandemic as they face what the insurer calls a “complex macro environment and permacrisis state”—a state which has included the pandemic, persistent high inflation, international turmoil and war, and more.
    • “Those are among the findings in MetLife’s 22nd annual U.S. Employee Benefit Trends Study, released March 18—data indicating that employers may have to revisit benefits offerings to not only support employees, but retain them.”
  • HR Dive explains “How menopausal and other reproductive health benefits can help retain women” and “Data shows that fertility treatments are extremely valuable to workers who need them. Here’s why one people officer is working on integrating them.”
  • STAT News relates,
    • “Just as Pfizer spooked Wall Street after its record pandemic revenue came parabolically back to earth, BioNTech, the company’s Covid-19 vaccine partner, is now dealing with investor malaise of its own.
    • “Shares in the German firm fell about 5% yesterday, hitting a 52-week low, after the company reported disappointing financials. BioNTech’s cut of Covid vaccine revenue fell by about more than three-quarters last year, missing analyst estimates and leading the company to lower its projections for 2024.
    • “Now BioNTech, much like Pfizer, is making the case that its future in oncology will compensate for the rapid erosion in demand for Covid vaccines. The company has more than 20 cancer medicines in its pipeline, including late-stage treatments for tumors of the breast and lung that could hit the market in the next two years.”
  • Per Healthcare Dive,
    • “Walgreens-backed VillageMD sold 11 locations in Rhode Island to Boston-based medical group management firm Arches Medical Partners for an undisclosed sum, Arches said Wednesday.
    • “The practices, which include about 75,000 patients, joined Arches on March 2, according to VillageMD’s website. 
    • “The deal follows VillageMD clinic closures. The primary care chain recently exited Florida — once one of chain’s largest markets — and plans to withdraw from its home state in Illinois next month.”

Midweek Update

David Ermer–CMS, Congress, COVID-19, Cybersecurity, Employee Wellness Programs, FDA, Generative AI, Medical / Rx research, Mental health care, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Speaker Mike Johnson, R-La., and his top lieutenants on Wednesday morning moved to quell reservations among their conference about the emerging $1.2 trillion-plus final spending package headed for a vote likely on Friday, while their Democratic counterparts did likewise in a separate meeting.
    • “Appropriators were scrambling under a tight timeline to finish drafting the measure, which is taking longer than expected due to a last-minute decision to write a full-year Homeland Security bill. But Johnson told reporters after a GOP conference meeting that text is expected as soon as Wednesday afternoon.
    • “Other sources expected the bill drop to slip to Thursday, with the standard “reading out” of the DHS title, to catch any errors before posting, not even expected to begin until later Wednesday. But no matter: Lawmakers said they expect the chamber to vote as soon as Friday, regardless of a 72-hour review rule. * * *
    • “Final passage wouldn’t come until this weekend at the earliest, and senators are working to accommodate Sen. Susan Collins, R-Maine, who has never missed a vote but will be attending her mother’s funeral on Saturday. That could push votes off until Sunday or Monday, though few are worried at this point about the effects of such a brief funding lapse. 
    • “I don’t think we’ll do a [continuing resolution],” Johnson said.”
  • The American Hospital Association (AHA) News informs us,
    • “The House Energy and Commerce Committee March 20 unanimously passed AHA-supported legislation to reauthorize through 2029 the Dr. Lorna Breen Health Care Provider Protection Act (H.R. 7153), which provides grants to help health care organizations offer behavioral health services for front-line health care workers. The bill also would reauthorize a national campaign that provides hospital leaders with evidence-based solutions to support worker well-being. Without congressional action, the law will expire at the end of this year.”
  • and
    • “Congress should address any statutory constraints that prevent the Centers for Medicare & Medicaid Services and Department of Health and Human Services from adequately helping hospitals and other health care providers impacted by the Change Healthcare cyberattack, AHA said a letter submitted to the House Ways and Means Committee for a hearing March 20 with HHS Secretary Xavier Becerra on fiscal year 2025 funding for HHS.”
  • Govexec tells us,
    • “The top senator with direct oversight of the U.S. Postal Service is calling on its leadership to pause its overhaul of the agency’s mailing network due to potential impacts they are having on delivery, rejecting USPS assertions that is has provided transparency. 
    • “USPS should not continue its nationwide operational reforms until it can prove the changes will not negatively impact mail service, Sen. Gary Peters, D-Mich., who chairs the Senate Homeland Security and Governmental Affairs Committee, said in a letter to Postmaster General Louis DeJoy. Agency leadership said in response to the letter it has offered volumes of documents and many staff-level briefings to Congress, though Peters said USPS ignored many of his requests for additional information on its efforts and left Congress uncertain about the fallout that could befall postal customers.”
  • On March 18, 2024, the Office of Management and Budget’s Office of Information and Regulatory Affairs received for final regulatory review an OPM proposed rule with additional requirements and clarifications for the Postal Service Health Benefits Program (RIN 3206-AO59).
  • The AHA News tells us,
    • “U.S. health care organizations should immediately transition away from using certain unauthorized plastic syringes made in China by Jiangsu Caina Medical Co. and Jiangsu Shenli Medical Production Co., and should only use other plastic syringes made in China until they can transition to alternatives, the Food and Drug Administration announced March 19, citing potential quality and performance issues. The recommendations do not apply to glass syringes, pre-filled syringes, or syringes used for oral or topical purposes, FDA said. The agency advises health care providers to confirm the manufacturing location by reviewing the labeling, outer packaging, or contacting the supplier or group purchasing organization.”
  • The Assistant Secretary of Labor for Employee Benefit Security, Lisa M. Gomez, posted on her blog about “Health and Money Smarts for Women.”
  • Fierce Healthcare lets us know,
    • “The Employee Retirement Income Security Act, or ERISA, is turning 50 this year and lawmakers are curious to hear about how the law could be updated to increase coverage affordability and care access.
    • “Payers and providers, it turns out, have very different ideas on where Congress should focus its efforts.
    • “In response to the House Committee on Education and the Workforce’s January request for information, lobbying groups representing both sides of the industry weighed in on the act that outlines federal guidelines for employee benefit plans, including employer-sponsored group health plans.”
    • The article delves into these comments.
  • Newfront offers insights about 2024 RxDC reporting considerations. The reports are due June 1, 2025.
  • The Congressional Budget Office released a presentation about “The Federal Perspective on Coverage of medications to treat obesity. Assuming Congress allows Medicare to cover anti-obesity medications (AOM),
  • “The future price trajectory of AOMs is highly uncertain.
    • “CBO expects semaglutide to be selected for price negotiation by the Secretary of Health and Human Services within the next few years, which would lower its price (and potentially the prices of other drugs in the AOM class).
    • “CBO expects generic competition for semaglutide and tirzepatide to start in earnest in the second decade of a policy allowing Medicare Part D to cover AOMs.
    • “New AOMs are expected to become available. The new drugs might be more effective, have fewer side effects, or be taken less frequently or more easily than current medications. Those improvements could translate to higher prices, on average, even if prices decline for drugs that exist today.”
  • See also the Beckers Hospital Review article below on the next generation of AMOs.
  • Healthcare Dive tells us,
    • “The Medicare Advisory Payment Commission, which advises Congress on Medicare policy, is recommending boosting hospital payment rates by 1.5% in 2025 and base physician payment rates by 1.3% above current law, according to its annual report released Friday. 
    • “MedPAC suggested tying the rate of physician payment increasesmoving forward to the Medicare Economic Index, an annual measure of practice cost inflation. MedPAC suggested payments increase “by the amount specified in current law plus 50% of the projected increase in the MEI.”
    • “Provider groups, including the Medical Group Management Association and American Medical Association, have said the proposed payment increases are inadequate.”

From the public health and medical research front,

  • The Washington Post reports,
    • “More than two-thirds of young children in Chicago could be exposed to lead-contaminated water, according to an estimate by the Johns Hopkins Bloomberg School of Public Health and the Stanford University School of Medicine.
    • “The research, published Monday in the journal JAMA Pediatrics, estimated that 68 percent of children under the age of 6 in Chicago are exposed to lead-contaminated drinking water. Of that group, 19 percent primarily use unfiltered tap water, which was associated with a greater increase in blood lead levels.
    • “The extent of lead contamination of tap water in Chicago is disheartening — it’s not something we should be seeing in 2024,” lead author Benjamin Huynh, assistant professor of environmental health and engineering at the Johns Hopkins Bloomberg School of Public Health, said in a news release.”
  • The Wall Street Journal relates,
    • “Debi Lucas had a tremor in her arm. Her feet froze when she tried to walk and she fell into her coffee table, busting her lip. 
    • “She went to a neurologist who thought she had Parkinson’s disease. Doctors normally diagnose the neurodegenerative condition by symptoms. Lucas, 59, had them. 
    • “But the neurologist, Dr. Jason Crowell, couldn’t be sure. The symptoms might be related to a traumatic brain injury Lucas suffered in a car accident decades earlier, he thought. Or they might be from her medications. 
    • “To find an answer, Crowell turned to a new test: a skin biopsy that can detect an abnormal protein people with Parkinson’s have inside their nerves. He took samples of skin near her ankle, knee and shoulder and sent them to a lab. 
    • “The results confirmed that Lucas has Parkinson’s. The diagnosis was scary, but Lucas finally knew what was causing her symptoms. “I was glad to have a name on it,” she said. 
    • “The test sped her diagnosis, said Crowell, a movement-disorders neurologist at the Norton Neuroscience Institute in Louisville, Ky. “It just gives me more confidence,” he said. 
    • “The skin test is an important part of progress researchers are making against Parkinson’s, the second-most common age-related neurodegenerative condition, which is on the rise and a major driver of disability, dementia and death. The test Lucas received, made by CND Life Sciences, a medical technology company in Scottsdale, Ariz., is one of a few in use or development to allow doctors to diagnose Parkinson’s based on biology rather than symptoms that can take years to appear“.
  • Medscape explains “why a new lung cancer treatment is so promising.”
  • MedPage Today notes,
    • “The FDA has approved aprocitentan (Tryvio), making it the first endothelin receptor antagonist for the treatment of high blood pressure (BP), Idorsia Pharmaceuticals announced on Wednesday.
    • “The once-daily oral medication is indicated in combination with other antihypertensive drugs to lower BP in adult patients who do not have their BP controlled with other therapies.
    • “It is believed that some people may respond better to the drug’s novel mechanism, as aprocitentan is a dual endothelin receptor antagonist that works differently than conventional diuretics, renin-angiotensin-aldosterone system antagonists, calcium channel blockers, and beta-blockers used to lower BP.”
  • Beckers Hospital Review considers the three generations of weight loss drugs.
    • “Anita Courcoulas, MD, defines GLP-1s as “generation one;” dual GLP-1 and GIPs as the second; and a triple threat of GLP-1, GIP and GCGRs as the third generation of weight loss drugs. 
    • “Dr. Courcoulas is chief of Pittsburgh-based UPMC’s minimally invasive bariatric and general surgery program. She told Becker’s the next class of anti-obesity medications are finally reaching weight loss outcomes seen from gastric sleeve and bypass procedures, the two most common surgeries for trimming pounds. * * *
    • “Dr. Courcoulas said the biggest unknown is long-term durability of these medications, a concern other bariatric experts have raised. 
    • “She expects GLP-GIP-GCGR medications to gain approval and enter the U.S. market next year. 
    • “I think it’s very exciting to realize there are medications that are under investigation now that could come to market that could have even better weight loss results than the two drug [classes] we’re seeing now,” Dr. Courcoulas said.”
  • The National Institutes of Health announced,
    • “SARS-CoV-2, the virus that causes COVID-19, can damage the heart even without directly infecting the heart tissue, a National Institutes of Health-supported study has found. The research, published in the journal Circulation, specifically looked at damage to the hearts of people with SARS-CoV2-associated acute respiratory distress syndrome (ARDS), a serious lung condition that can be fatal. But researchers said the findings could have relevance to organs beyond the heart and also to viruses other than SARS-CoV-2.
    • “Scientists have long known that COVID-19 increases the risk of heart attack, stroke, and Long COVID, and prior imaging research has shown that over 50% of people who get COVID-19 experience some inflammation or damage to the heart. What scientists did not know is whether the damage occurs because the virus infects the heart tissue itself, or because of systemic inflammation triggered by the body’s well-known immune response to the virus.
    • “This was a critical question and finding the answer opens up a whole new understanding of the link between this serious lung injury and the kind of inflammation that can lead to cardiovascular complications,” said Michelle Olive, Ph.D., associate director of the Basic and Early Translational Research Program at the National Heart, Lung, and Blood Institute (NHLBI), part of NIH. “The research also suggests that suppressing the inflammation through treatments might help minimize these complications.”
  • and
    • “An investigational gene therapy for a rare neurodegenerative disease that begins in early childhood, known as giant axonal neuropathy (GAN), was well tolerated and showed signs of therapeutic benefit in a clinical trial led by the National Institutes of Health (NIH). Currently, there is no treatment for GAN and the disease is usually fatal by 30 years of age. Fourteen children with GAN, ages 6 to 14 years, were treated with gene transfer therapy at the NIH Clinical Center and then followed for about six years to assess safety. Results of the early-stage clinical trial appear in the New England Journal of Medicine. 
    • “The gene therapy uses a modified virus to deliver functional copies of the defective GAN gene to nerve cells in the body. It is the first time a gene therapy has been administered directly into the spinal fluid, allowing it to target the motor and sensory neurons affected in GAN. At some dose levels, the treatment appeared to slow the rate of motor function decline. The findings also suggest regeneration of sensory nerves may be possible in some patients. The trial results are an early indication that the therapy may have favorable safety and tolerability and could help people with the rapidly progressive disease.
    • “One striking finding in the study was that the sensory nerves, which are affected earliest in GAN, started ‘waking up’ again in some of the patients,” said Carsten G. Bonnemann, M.D., senior author and chief of the Neuromuscular and Neurogenetic Disorders of Childhood Section at the National Institute of Neurological Disorders and Stroke (NINDS), part of NIH. “I think it marks the first time it has been shown that a sensory nerve affected in a genetic degenerative disease can actually be rescued with a gene therapy such as this.”
  • Lifesciences Intelligence reports,
    • “Recently, JAMA Network Open published a study analyzing the association between a healthy diet, sleep duration, and type 2 diabetes (T2D) risk. The study data revealed that habitual short sleep duration was linked to an increased probability of T2D by as much as 41%.
    • “Using data on 247,867 individuals from the UK biobank, researchers divided patients into groups based on their sleeping habits. The stratified groups included normal (7–8 hours per night), mildly short (6 hours per night), moderately short (5 hours per night), and extremely short (3–4 hours per night).
    • “Across all study participants, only 3.2% were diagnosed with T2D; however, the adjusted hazard ratios revealed that the prevalence of T2D was higher among shorter sleep groups. More specifically, the increased probability of T2D was identified in those who slept 5 hours or less per night. Those in the moderate short sleep group were 16% more likely to have a T2D diagnosis. Additionally, those in the extremely short sleep group had a 41% greater likelihood of being diagnosed with T2D.”

From the U.S. healthcare business front,

  • BioPharma Dive relates,
    • “Orchard Therapeutics said Wednesday it will offer a new gene therapy to children with a rare, devastating disease at a record-setting wholesale price of $4.25 million. 
    • “The therapy, Lenmeldy, won Food and Drug Administration approval on Monday to treat patients with early-onset metachromatic leukodystrophy, or MLD. The disease, which most often attacks infants between six months and two years of age, robs patients of the ability to walk, talk and function in the world, killing most of its earliest victims within five years of onset.
    • “Lenmeldy’s price tag will leapfrog those of the two most expensive gene therapies available in the U.S. Sarepta Therapeutics sells its Elevidys treatment for Duchenne muscular dystrophy for $3.2 million, while CSL and UniQure’s hemophilia treatment Hemgenix costs $3.5 million.”
  • MedPage Today lets us know,
    • “Despite being a growing percentage of the physician workforce, women physicians continued to be paid less than their male colleagues, a strong body of evidence shows.
    • “While the gender pay gap decreased by 2% from 2021 to 2022 — from 28% to 26% — the gap was still significant, according to online networking service Doximity’s 2023 physician compensation reportopens in a new tab or window.
    • “Women doctors in 2022 earned nearly $110,000 less per year than men physicians, on average, after adjusting for specialty, location, and years of experience. Data from individual states have backed up this figure, too. For instance, in 2022, the Maryland State Medical Society conducted a survey and found that women doctors in Maryland are paid about $100,000 less annually than men.”
  • Beckers Hospital Review lists ten common issues in pharmacies.
  • United Healthcare updated its Change Healthcare cyberattack response website today.
  • HR Daily Advisor explains how companies are exploring the limitations of employee assistance plans amid the country’s mental health crisis.
  • Forbes reports,
    • “Medical diagnosis and procedure codes are so numerous and varied that Debbie Beall, manager of coding at Houston Methodist in Texas, needs a 49-person team to translate the medical notes written by the system’s 1,600 clinicians into the codes needed to bill insurers.
    • “There is a medical code for every imaginable scenario – from “burn due to water-skis on fire” to “spacecraft collision injuring occupant” — and their specificity determines how much the insurance companies pay. Each team member processes anywhere from 70 to 250 claims per day, depending on the complexity, she said. That’s why Beall is so excited about the possibility of using artificial intelligence to speed up the job.
    • “There’s no way I’m ever going to replace coders completely with an AI system,” Beall told Forbes. But for run-of-the-mill procedures performed multiple times a day in a hospital, like X-rays and EKGs? “Yes, an AI engine can do that.”
    • “Beall was one of the first dozen or so people to test a prototype of an AI-powered medical coding tool from electronic health records giant Epic Systems, which had $4.6 billion in revenue in 2022. Based on GPT-4, the large language model that powers the viral chatbot ChatGPT, Epic’s coding assistant prototype ingests and summarizes clinician notes and then tees up the “most likely” diagnosis codes and procedures codes, along with suggestions of “other potential codes,” according to mock ups viewed by Forbes that did not include real patient information. * * *
    • “While Epic has so far focused on using generative AI in back office functions, it has also been working on a patient-facing application that wouldn’t require human review. Krause told Forbes a tool that would help explain the patient’s bill, including their deductible and outstanding balance, could be rolled out by November. “We feel like that’s a fairly benign place to start. It’s not about healthcare at that point, but it’s really about their billing,” he said. “That’s not going to harm a patient in any way.”

   

Midweek Update

David Ermer–CMS, Cybersecurity, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Federal News Network builds on OPM’s March 12 press release about the Postal Service Health Benefits Program launch in January 2025.
  • STAT News calls attention to healthcare points that you might have missed in the President’s FY 2025 budget. For example,
    • “The budget proposes for the first time a change to the law that would let pharmacists fill prescriptions for brand-name biologics with biosimilars without doctor permission. The measure is part of the administration’s plan to lower drug costs. * * *
    • “Besides budget boosts for behavioral health services, research, and the 988 crisis hotline, the administration is asking Congress for legislative changes to make mental health care more accessible. Those include eliminating Medicare’s 190-day lifetime limit on psychiatric services in hospitals, which it estimates would cost the program $2.9 billion over 10 years. * * *
    • “Medicare would also have to cover three behavioral health visits without cost-sharing, a move that could cost $1.5 billion over a decade. Biden wants to extend this requirement to private insurers as well, at an estimated cost of $428 million over that time.”
  • HealthDay informs us,
    • The White House on Wednesday launched a nationwide call for more training and better access to the lifesaving opioid overdose drug naloxone.
    • Called the Challenge to Save Lives from Overdose, the initiative urges organizations and businesses to commit to train employees on how to use opioid overdose medications, to keep naloxone in emergency kits and to distribute the drug to employees and customers so they might save a life at home, work or in their communities.
    • “Today, we’re calling on organizations and businesses — big and small, public and private — across the country to help ensure all communities are ready to use this lifesaving tool to reduce opioid deaths,” the White House said in a fact sheet announcing the new initiative. “As the drug supply has gotten more dangerous and lethal, we’re asking allies to join us because we all must do our part to keep communities safe.”
  • The CDC is offering free webinars on the RxDC process on March 27 and April 3.

From the Change Healthcare situation front,

  • United Healthcare updated its Change Healthcare situation response website this afternoon.
  • The HHS Office for Civil Rights, which enforces the HIPAA Privacy and Security Rule, issued a Dear Colleague letter about the Change Healthcare situation and announced opening an investigation of UHC about cyberattack and its fallout.
  • The Congressional Research Service posted an insight report titled “The Change Healthcare Cyberattack and Response Considerations for Policymakers.’
  • The American Medical Association explained how providers can navigate the Change Healthcare situation.

From the public health and medical research front,

  • The New York Times reports,
    • “Early detection of colon cancer can prevent a majority of deaths from this disease, possibly as much as 73 percent of them. But just 50 to 75 percent of middle-aged and older adults who should be screened regularly are being tested.
    • “One reason, doctors say, is that the screening methods put many people off.
    • “There are two options for people of average risk: a colonoscopy every 10 years or a fecal test every one to three years, depending on the type of test.
    • “Or, as Dr. Folasade P. May, a gastroenterologist at UCLA Health puts it, “either you take this horrible laxative and then a doctor puts an instrument up your behind, or you have to manipulate your own poop.”
    • “But something much simpler is on the horizon: a blood test. Gastroenterologists say such tests could become part of the routine blood work that doctors order when, for example, a person comes in for an annual physical exam. * * *
    • “A study published on Wednesday in The New England Journal of Medicine found that a blood test searching for such [colon cancer] DNA called Shield and made by the company Guardant Health detected 87 percent of cancers that were at an early and curable stage. The false positive rate was 10 percent.
    • “But there is a caveat to the blood test: While it detects cancers, it misses most large polyps, finding just 13 percent of them. In contrast, the fecal test detects 43 percent and a colonoscopy finds 94 percent, Dr. Carethers said.
    • “While polyps are usually harmless, a few can turn into cancers, so doctors want to find all of them and remove them to prevent cancers from forming.”
  • The Department of Health and Human Services posted a fact sheet on in vitro fertilization across our country.
  • BioPharma Dive tells us,
    • “Merck on Wednesday announced plans to start clinical trials testing a newer version of its vaccine for human papillomavirus, or HPV, as well as a different regimen of the shot it currently sells.
    • “The trials are bids to improve upon vaccines Merck currently markets as Gardasil and Gardasil 9. One will test a shot meant to provide protection against more strains of HPV. The other will evaluate a single-dose regimen of Gardasil 9. Both studies should begin in the fourth quarter of this year. 
    • “Gardasil is approved for use against genital warts and to prevent several cancers caused by stains of HPV. The vaccine is one of Merck’s top-selling products and still growing. It generated $8.9 billion in sales in 2023, up 29% from the previous year.” 
  • STAT News informs us,
    • “For four decades, researchers and companies searched for ways to replace the broken blood-clotting genes that cause hemophilia, a multibillion dollar effort designed to turn a chronic, sometimes debilitating disease into a curable one. 
    • “But the first two gene therapies have so far been met with crickets. Only a handful of patients with hemophilia B, the rarer form of the disease, appear to have been treated worldwide since Hemgenix was approved in November 2022. After Roctavian was approved for hemophilia A last June, only three patients were treated through the rest of the year.
    • “The issue doesn’t appear to be access. Hemgenix and Roctavian, marketed by the Australian biotech CSL Behring and the San Francisco biotech BioMarin, are Malibu-mini-mansion expensive: $3.5 million and $2.9 million, respectively. But current hemophilia treatments can run over $1 million per year. So most insurers have been happy to pay the lump sum.
    • “​​You can’t blame the payers this time,” said Michael Sherman, former chief medical officer of the nonprofit insurer Harvard Pilgrim.” 
  • The National Cancer Institute posted research highlights.
  • The National Institutes of Health announced,
    • “Researchers at the National Institutes of Health (NIH) have discovered that symptoms of attention-deficit/hyperactivity disorder (ADHD) are tied to atypical interactions between the brain’s frontal cortex and information processing centers deep in the brain. The researchers examined more than 10,000 functional brain images of youth with ADHD and published their results in the American Journal of Psychiatry. The study was led by researchers at NIH’s National Institute of Mental Health and National Human Genome Research Institute. * * *
    • “The findings from this study help further our understanding of the brain processes contributing to ADHD symptoms—information that can help inform clinically relevant research and advancements.”
  • The Institute for Clinical and Economic Review published a “Final Evidence Report on Treatments for Paroxysmal Nocturnal Hemoglobinuria. — Independent appraisal committee voted that current evidence is not adequate to demonstrate a net health benefit for iptacopan over C5 inhibitor; committee voted that the evidence is adequate to demonstrate a net health benefit for add-on danicopan compared to C5 inhibitor alone.”
  • Medscape relates,
    • “Chronic smoking remains a major cause of premature mortality on a global scale. Despite intensified efforts to combat this scourge, a quarter of deaths among middle-aged adults in Europe and North America are attributed to it. However, over the past decades, antismoking campaigns have borne fruit, and many smokers have quit before the age of 40 years, enabling some case-control studies.
    • “Among those abstainers who made the right choice, the excess mortality attributable to smoking over a lifetime would be reduced by 90% compared with controls who continued smoking. The estimated benefit is clear, but the analysis lacks nuance. Is smoking cessation beneficial even at older ages? If so, is the effect measurable in terms of magnitude and speed of the effect? An article published online on February 8, 2024, in The New England Journal of Medicine Evidenceprovided some answers to these questions.”

From the HIMSS conference front,

  • Healthcare IT News reports “Samsung focuses on intuitive mobile tech and wearables at HIMSS24. These technologies can help cure healthcare worker burnout, patient confusion and inefficient communications between care teams, says a top exec and nurse.”
  • Forbes explains why AI is taking center stage at the conference.
    • “At the HIMSS conference in Orlando, healthcare leaders, including CIOs, CMIOs, CNIOs, and other C-suite members, were focused on AI as the central theme. They explored how healthcare organizations can better utilize their clinical data. They identified security, AI platforms, and workforce optimization as the three main areas for healthcare AI development.”
  • In related news, Health IT Analytics lets us know,
    • “Researchers from Mount Sinai have been awarded a four-year, $3 million grant from the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) to develop artificial intelligence (AI)-driven prediction models to flag risk of cardiovascular disease events in patients with obstructive sleep apnea.
    • “The American Heart Association (AHA) indicates that obstructive sleep apnea increases patients’ risk of cardiovascular disease, including coronary artery disease, hypertension and stroke. The use of continuous positive airway pressure (CPAP) machines is often prescribed to treat sleep apnea, but evidence to suggest the benefits of CPAP use in relation to cardiovascular event rates is limited.
    • “To bridge this gap, the research team will build machine learning (ML) tools to identify obstructive sleep apnea patients at high risk for atherosclerosis progression and cardiovascular events like stroke and heart attack.”

In other U.S. healthcare business news,

  • The Wall Stree Journal reports,
    • “People seeking a popular new weight-loss drug will have a new home-delivery option from a familiar name: Amazon.com.
    • “Amazon Pharmacy, which has sold prescription medicines online since 2020, will now handle some of the home delivery of anti-obesity therapy Zepbound and other Eli Lilly drugs that are ordered through the drugmaker’s new direct-to-consumer service, the companies said Wednesday.
    • “The service, called LillyDirect, connects patients with telehealth services specializing in obesity that can write prescriptions for Zepbound or another weight-loss drug. The service also arranges for a prescription to be processed and mailed directly to customers.” 
  • The Society for Human Resource Management notes,
    • “According to the latest Employer Costs for Employee Compensation report, released March 13 by the U.S. Bureau of Labor Statistics (BLS), employers spent 3.8 percent more on wages and benefits in December 2023 compared to September 2023.
    • “Total employer compensation costs for private-industry workers averaged $43.11 per hour worked in December 2023. Wages and salaries averaged $30.33 per hour worked and accounted for 70.4 percent of employer costs, while benefit costs averaged $12.77 per hour worked and accounted for the remaining 29.6 percent, according to the BLS report.
    • :That’s a significant jump from the total employer compensation costs for those same workers last fall, and one indicating that despite slowing compensation growth over the past year, bigger hikes are not yet over.”

Tuesday Tidbits

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

From Washington DC

  • Healthcare Dive informs us,
    • “The CMS rolled out several flexibilities on Tuesday that aim to help providers’ mounting financial challenges in the wake of the cyberattack against Change Healthcare.
    • “The agency instructed Medicare administrative contractors, who process claims for the government, to expedite provider requests to switch to new clearinghouses to get around the Change outage. CMS is also encouraging Medicare Advantage plans, Part D sponsors, and Medicaid and Children’s Health Insurance Program managed care plans to relax prior authorization requirements or offer advance funding. 
    • “The agency said providers can submit requests for accelerated payment to their Medicare administrative contractors for individual consideration.”
  • Fierce Healthcare adds,
    • “Availity, another clearinghouse, is used by Humana and Elevance Health. Humana CEO Bruce Broussard said a lot of business is shifting from Change to Availity.
    • “Elevance Executive Vice President and CFO Mark Kaye noted they’ve noticed providers have been able to adapt in the days after the cyberattack.
    • “Today, we’re about down to a 10% reduction relative to normal daily volumes,” said Kaye. “Some providers are now submitting claims directly to Availity, while others have switched their clearinghouse.”
  • Axios tells us that in the wake of the CDC’s recent decision to treat Covid like other respiratory illnesses,
    • “The HHS’s free COVID test program was suspended because of the lowering case rates after the winter respiratory season, though the agency may resume it in the future as needed.
    • “Orders for free tests placed on or before Friday will be delivered, per HHS.” 
  • Per an HHS press release,
    • “The Justice Department’s Antitrust Division, Federal Trade Commission (FTC) and Department of Health and Human Services (HHS) jointly launched a cross-government public inquiry into private-equity and other corporations’ increasing control over health care.
    • “Private equity firms and other corporate owners are increasingly involved in health care system transactions and, at times, those transactions may lead to a maximizing of profits at the expense of quality care. The cross-government inquiry seeks to understand how certain health care market transactions may increase consolidation and generate profits for firms while threatening patients’ health, workers’ safety, quality of care and affordable health care for patients and taxpayers.
    • “The agencies issued a Request for Information – PDF (RFI) requesting public comment on deals conducted by health systems, private payers, private equity funds and other alternative asset managers that involve health care providers, facilities or ancillary products or services. The RFI also requests information on transactions that would not be reported to the Justice Department or FTC for antitrust review under the Hart-Scott-Rodino Antitrust Improvements Act.”
  • The Food and Drug Administration announced,
    • “Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. Importantly, this system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition. “
  • The Congressional Research Service issued an In Focus report about the Federal Employee Paid Parental Leave Benefit.
  • The U.S. Office of Personnel Management announced,
    • Today, the National Aeronautics and Space Administration (NASA) and the U.S. Office of Personnel Management (OPM) welcomed its new class of next generation Artemis astronauts in a ceremony at the agency’s Johnson Space Center on Tuesday. The ten astronaut graduates are now eligible for flight assignments. The agencies also announced the opening for the next round of NASA astronaut applications.  

From the public health and medical research front,

  • The Washington Post reports,
    • “The mortality rate for U.S. women with breast cancer fell an estimated 58 percent from 1975 to 2019, according to research published in JAMA that credits the decline to advances in screening and treatments.
    • “Nearly half (47 percent) of the reduction was attributed to earlier and more effective treatment of those with Stage 1, 2 or 3 breast cancer. (With staging, generally the lower the number, the less the cancer has spread.)
    • “In addition, about 25 percent of the drop was attributed to improved mammography screening and about 29 percent to better treatment of metastatic breast cancer, meaning cancer that has spread.”
  • The Wall Street Journal points out,
    • “Novo Nordisk’s blockbuster weight-loss drug cuts the risk of kidney disease-related events in diabetic patients by 24%, according to a new clinical trial conducted by the Danish pharmaceutical company.
    • “Headline results from a five-year study of Semaglutide, which is marketed as Ozempic to treat diabetes, show that diabetic patients with chronic kidney disease saw a statistically significant and superior reduction in kidney disease progression, major adverse cardiovascular events and death, it added.
    • “The announcement follows October’s decision to stop the trial, known as FLOW, early thanks to successful results.
    • “Last year, a separate trial of Novo Nordisk’s obesity drug Wegovy showed that it cuts the risk of heart attacks and strokes.”
  • The National Institutes of Health adds,
    • “A weekly injection of semaglutide was safe and reduced the amount of fat in the liver by 31% in people with HIV and metabolic dysfunction-associated steatotic liver disease (MASLD), according to a presentation today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. This is the first clinical trial of semaglutide for MASLD in people with HIV. The research was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and conducted in the United States and Brazil by ACTG, a global clinical trials network focused on HIV and other infectious diseases. ACTG is funded by NIAID and collaborating NIH institutes. McGovern Medical School at UTHealth Houston also contributed funding for this study.
    • “Previously known as nonalcoholic fatty liver disease, MASLD is characterized by the accumulation of excess fat in the liver that is not caused by alcohol consumption or viral hepatitis. Over time, fat deposits may cause inflammation and cellular damage, and can result in cardiovascular and liver disease. MASLD also is associated with obesity, type 2 diabetes, and other metabolic disorders. It is the most common cause of chronic liver disease in the United States, and a leading reason for liver transplantation. An estimated 30-40% of people with HIV experience MASLD, slightly higher than the average among people without HIV.Semaglutide is an antidiabetic medication approved for use for the treatment of type 2 diabetes and an anti-obesity medication used for long-term weight management.”
  • Medscape relates,
    • “A new and deceptively simple advance in chronic stroke treatment could be a vibrating glove.
    • “Researchers at Stanford University and Georgia Tech have developed a wearable device that straps around the wrist and hand, delivering subtle vibrations (akin to a vibrating cellphone) that may relieve spasticity as well as or better than the standard Botox injections.
    • “The vibro-tactile stimulation can be used at home, and we’re hoping it can be relatively low cost,” said senior study author Allison Okamura, PhD, a mechanical engineer at Stanford University, Stanford, California.
    • “For now, the device is available only to clinical trial patients. But the researchers hope to get the glove into — or rather onto — more patients’ hands within a few years. A recent grant from the National Science Foundation’s Convergence Accelerator program could help pave the way to a commercial product. The team also hopes to expand access in the meantime through larger clinical trials with patients in additional locations.”
  • The New York Times reports,
    • “Determining whether someone has Alzheimer’s disease usually requires an extended diagnostic process. A doctor takes a patient’s medical history, discusses symptoms, administers verbal and visual cognitive tests.
    • “The patient may undergo a PET scan, an M.R.I. or a spinal tap — tests that detect the presence of two proteins in the brain, amyloid plaques and tau tangles, both associated with Alzheimer’s.
    • “All of that could change dramatically if new criteria proposed by an Alzheimer’s Association working group are widely adopted.
    • “Its final recommendations, expected later this year, will accelerate a shift that is already underway: from defining the disease by symptoms and behavior to defining it purely biologically — with biomarkers, substances in the body that indicate disease.
    • “The draft guidelines, Revised Criteria for Diagnosis and Staging of Alzheimer’s Disease, call for a simpler approach. That could mean a blood test to indicate the presence of amyloid. Such tests are already available in some clinics and doctors’ offices.”
    • “Someone who has biomarker evidence of amyloid in the brain has the disease, whether they’re symptomatic or not,” said Dr. Clifford R. Jack Jr., the chair of the working group and an Alzheimer’s researcher at the Mayo Clinic.
    • “The pathology exists for years before symptom onset,” he added. “That’s the science. It’s irrefutable.”

From the U.S. healthcare business front,

  • Becker’s Hospital Review lets us know,
    • “Danville, Pa.-based Geisinger appointed Terry Gilliland, MD, as the next president and CEO of Geisinger Health.
    • “Dr. Gilliland will succeed Jaewon Ryu, MD, JD, after he transitions to CEO of Risant Health, a nonprofit organization created by Kaiser Foundation Hospitals. Oakland, Calf.-based Kaiser Permanente agreed to acquire Geisinger last year as the first health system to join Risant, and the deal is waiting on regulatory approval.
    • “Geisinger’s board conducted an extensive search for Dr. Ryu’s successor.
    • “The role of leading Geisinger is unique,” said Heather Acker, chair of the Geisinger board of directors, in a news release. “It requires passion for our mission–to make better health easier for our patients and members across Pennsylvania; a drive to innovate care delivery; and a commitment to educating future caregivers. We are confident that Dr. Gilliland is the right person to lead Geisinger on our path forward.”
  • According to Fierce Healthcare,
    • “Insurance network coverage dramatically impacts whether a person remains in treatment for opioid use disorder, according to results shared by treatment provider Ophelia.
    • “A new study finds that nearly three-quarters (72.3%) of patients receiving opioid treatment through network insurance stayed in treatment for at least six months. Patients received telehealth treatment from Ophelia.”
  • Bloomberg reports,
    • “The US Department of Labor’s new worker classification rule is facing at least four lawsuits alleging the regulation is illegal, with less than a week before the new policy is set to go into effect.
    • “Freelance writers, a trucking company, and groups representing construction, financial services, and tech companies have filed four separate legal challenges in federal district court in Texas, Georgia, Tennessee, and Louisiana contending the new standard, which will make it harder for businesses to use independent contractors, violates the Administrative Procedure Act and departs from the text of the Fair Labor Standards Act. 
    • “The growing pile of lawsuits threatens to disrupt the Biden administration’s implementation of the new rule due to take effect March 11. The DOL says the regulatory update will better protect workers from misclassification, but the business community warns it could have major consequences for industries that rely on independent contractors to operate their services—like Uber Technologies Inc. and Lyft Inc., as well as the trucking, construction, and other sectors. 
    • “And the multi-district nature of the litigation also could lead to splits among the district and appellate courts, inviting potential US Supreme Court review.” 

Weekend update

David Ermer–Congress, Federal employment benefits, Mental health care, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

From Washington DC,

  • The Hill reports,
    • “Congressional leaders on Sunday finally revealed long-awaited bipartisan bills to fund parts of the government for most of the year, setting off a bicameral sprint to avert looming shutdown threat in less than a week.    
    • “The weekend rollout entails six full-year spending bills to fund a slew of agencies until early fall, including the departments of Agriculture, Interior, Transportation (DOT), Housing and Urban Development (HUD), Veterans Affairs (VA), Justice (DOJ), Commerce and Energy.   
    • “The 1,050-page bipartisan package includes more than $450 billion in funding for fiscal year 2024. Lawmakers have until Friday to pass the legislation or risk a partial government shutdown under a stopgap plan President Biden signed into law this week to buy more time for spending talks.” 
  • KFF discusses the work of the Consumer Financial Protection Bureau.
    • “When President Barack Obama signed legislation in 2010 to create the Consumer Financial Protection Bureau, he said the new agency had one priority: “looking out for people, not big banks, not lenders, not investment houses.”
    • “Since then, the CFPB has done its share of policing mortgage brokers, student loan companies, and banks. But as the U.S. health care system turns tens of millions of Americans into debtors, this financial watchdog is increasingly working to protect beleaguered patients, adding hospitals, nursing homes, and patient financing companies to the list of institutions that regulators are probing.
    • “In the past two years, the CFPB has penalized medical debt collectors, issued stern warnings to health care providers and lenders that target patients, and published reams of reports on how the health care system is undermining the financial security of Americans.
    • “In its most ambitious move to date, the agency is developing rules to bar medical debt from consumer credit reports, a sweeping change that could make it easier for Americans burdened by medical debt to rent a home, buy a car, even get a job. Those rules are expected to be unveiled later this year.”
  • Reg Jones, writing in FedWeek, explains FEHB coverage for children of federal and postal employees.
  • The Washington Post reports how “Yogurt makers may now claim that their products can reduce the risk of Type 2 diabetes, according to new guidance from the Food and Drug Administration — with some caveats.”

From the U.S. public health front,

  • The American Medical Association explains what doctors wish their patient knew about prostate cancer.
  • The Washington Post discusses how to recognize and address mild memory loss.
    • “More than occasional forgetfulness, MCI [mild cognitive impairment] causes problems that disrupt daily life but don’t make it impossible to function, said Ronald Petersen, director of the Mayo Clinic Alzheimer’s Disease Research Center and the Mayo Clinic Study of Aging. It is often but not always a precursor to dementia, he added.
    • “It’s a subtle condition,” said Petersen, who in 1999 led the first study differentiating patients with MCI from healthy subjects and those with dementia. If you miss a golf date once, no worries, he said, but if “that happened a couple of times last week and people in your family are starting to worry about you — well, that may be MCI.”
    • “With MCI, people can still drive, pay their bills and do their taxes — they just do so less efficiently,” Petersen said.
    • “A 2022 study in the journal Alzheimer’s & Dementia projected that 14.4 million people in the United States would have MCI in 2025, and 19.3 million in 2050. An American Academy of Neurology subcommittee estimated that about 1 in 10 people ages 70 to 74 had MCI, and 1 in 4 ages 80 to 84 in 2018. * * *
    • “Both patients and physicians need to be aware of the symptoms of cognitive decline,said Soeren Mattke, director of the Brain Health Observatory at the University of Southern California’s Dornsife Center for Economic and Social Research. “If you wait until someone’s obviously symptomatic — like they can’t find the door to the physician’s office — you’re going to be too late.”
  • Fortune Well offers advice about “7 habits that can help you lose weight—and keep it off—according to experts” and “4 expert-backed steps that will help you reach your fitness goals this year.”