Thursday Miscellany

Medicare

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.”

Midweek Update

David Ermer–CDC, CMS, FDA, Medical / Rx research, Medicare, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The President, joined by Sen. Bernie Sanders (I Vt) made remarks on the success of their efforts to lower the cost of medicine inhalers.
  • MedPage today tells us that the CDC Director, Dr. Mandy Cohen, spoke at the World Vaccine Congress.
    • “Although the risk to humans is very low, the case of the Texas farmworker apparently contracting pathogenic avian influenza A (H5N1) from a cow illustrates the importance of data collection, CDC Director Mandy Cohen, MD, MPH, said Tuesday.
    • “We need to continue to invest in data, in lab capacity, in our ability to respond to health threats, and we need a talented workforce,” Cohen said here at the World Vaccine Congress. In the realm of modernizing data collection, she added, “We cannot solve problems we don’t see.”
  • The Washington Post adds,
    • “Officials have said the risk to human health remains low. But the CDC has warned that people with unprotected exposure to infected birds or other animals, including livestock, are at greater risk of infection.
    • “People should also avoid uncooked or undercooked food, unpasteurized milk and raw cheese, according to the CDC. Cooking eggs or poultry to an internal temperature of about 165 degrees Fahrenheit generally “kills bacteria and viruses, including bird flu viruses,” it says. Backyard chickens or pet chickens are at risk if they come in contact with wild birds carrying the virus.
    • “Human symptoms of bird flu include eye redness, fever, coughing, sore throat, muscle or body aches, headaches, fatigue, shortness of breath or difficulty breathing. Diarrhea, nausea, vomiting or seizures are less common, the CDC said.”
  • Per an FDA press release,
    • Today, the U.S. Food and Drug Administration approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis; adults with acute bacterial skin and skin structure infections (ABSSSI); and adult and pediatric patients three months to less than 18 years old with community-acquired bacterial pneumonia (CABP).
    • “The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Zevtera will provide an additional treatment option for a number of serious bacterial infections,” said Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research. “The FDA will continue our important work in this area as part of our efforts to protect the public health.”
  • Per a National Safety Council press release,
    • Driving is the leading cause of work-related death each year in the United States, with nearly 40% of deaths on the job occurring on American roads according to the U.S. Bureau of Labor Statistics. A major contributing factor to road deaths each year, including work-related fatalities, is distracted driving, which takes thousands of lives on the country’s roads annually and leaves even more people seriously injured. 
    • To address this heartbreaking reality and the need for key stakeholders to come together on these intersecting safety topics, the Occupational Safety and Health Administrationand the National Safety Council are convening a panel discussion on the critical role employers play in roadway safety, Roadway Safety is Workplace Safety: The Need to Eliminate Distracted Driving, on April 10 during Distracted Driving Awareness Month.  * * *
    • The event takes place at the U.S. Department of Labor at 2:30 p.m. (ET) April 10. It is open to the public. Register to attend in person or virtually.

From the public health and medical research front,

  • The New York Times reports,
    • “The first patient to receive a kidney transplanted from a genetically modified pig has fared so well that he was discharged from the hospital on Wednesday, just two weeks after the groundbreaking surgery.
    • “The transplant and its encouraging outcome represent a remarkable moment in medicine, scientists say, possibly heralding an era of cross-species organ transplantation [or xenotransplant].
    • “Two previous organ transplants from genetically modified pigs failed. Both patients received hearts, and both died a few weeks later. In one patient, there were signs that the immune system had rejected the organ, a constant risk.
    • “But the kidney transplanted into Richard Slayman, 62, is producing urine, removing waste products from the blood, balancing the body’s fluids and carrying out other key functions, according to his doctors at Massachusetts General Hospital. * * *
    • “Whether Mr. Slayman’s body will eventually reject the transplanted organ is still unknown, Dr. Klassen noted. And there are other hurdles: A successful operation would have to be replicated in numerous patients and studied in clinical trials before xenotransplants become widely available.”
  • Health Day lets us know,
    • “Research offers a new reason to avoid vaping: It may raise your heart failure risk
    • “People who vaped had a 19% higher odds for the debilitating disease
    • “The risk held even after accounting for other heart risk factors or substance use.”
  • Medscape tells us,
    • “Nontraditional risk factors such as migraine and autoimmune diseases have a significantly greater effect on stroke risk in young adults than traditional risk factors such as hypertension, high cholesterol, and tobacco use, new research showed.
    • “The findings may offer insight into the increased incidence of stroke in adults under age 45, which has more than doubled in the past 20 years in high-income countries, while incidence in those over 45 has decreased.
    • “Investigators believe the findings are important because most conventional prevention efforts focus on traditional risk factors.
    • “The younger they are at the time of stroke, the more likely their stroke is due to a nontraditional risk factor,” lead author Michelle Leppert, MD, an assistant professor of neurology at the University of Colorado School of Medicine, Aurora, Colorado, said in a news release.
    • “The findings were published online on March 26, 2024, in Circulation: Cardiovascular Quality and Outcomes.”

From the U.S. healthcare business front,

  • MedCity News highlights health plan industry association concerns about Monday’s Medicare Advantage rate announcement.
  • Per Biopharma Dive,
    • “Genmab said Wednesday it’s agreed to pay $1.8 billion for ProfoundBio, gaining access to the biotechnology startup’s technology for developing antibody-drug conjugates, or ADCs.
    • “ProfoundBio’s portfolio includes Rina-S, a newer type of ADC it claims to be a potentially best-in-class medicine. The drug is designed to target tumors that express a protein called folate receptor alpha and is currently in Phase 2 testing for ovarian cancer and certain other types of solid tumors. 
    • “The all-cash transaction is expected to close by the end of June. The Danish drugmaker said the purchase will result in extra expenses this year as the company takes on responsibility for developing Rina-S and other ProfoundBio experimental medicines. It expects to update investors on its financial outlook upon releasing second-quarter earnings.”
  • MedPage Today informs us,
    • “More than $12 billion in payments were made from industry to physicians from 2013 to 2022, an analysis of payment data showed.
    • “Over this time period, 85,087,744 payments with a total value of $12.13 billion were made by industry to 826,313 physicians, with 93.8% of these payments associated with one or more marketed medical products, reported Andrew Foy, MD, of the Penn State Milton S. Hershey Medical Center in Hershey, Pennsylvania, and colleagues in a JAMAopens in a new tab or window research letter. * * *
    • “The top three drugs related to industry payments in the U.S. during the study period were rivaroxaban (Xarelto), apixaban (Eliquis), and adalimumab (Humira), with $176.34 million, $102.62 million, and $100.17 million in associated payments, respectively. The top medical devices related to industry payments were the da Vinci Surgical System, Mako SmartRobotics, and CoreValve Evolut, with $307.52 million, $50.13 million, and $44.79 million in associated payments, respectively.
    • “Top-paid specialties included orthopedic surgery, which received a total of $1.36 billion, neurology and psychiatry at $1.32 billion, and cardiology at $1.29 billion. Pediatric surgery and trauma surgery received the lowest sum of payments.
    • “Within each specialty, payments to the median physician ranged from $0 to $2,339, while the mean amount paid to the top 0.1% of physicians ranged from $194,933 for hospitalists to $4,826,944 for orthopedic surgeons. * * *
    • “The Physician Payments Sunshine Act established OpenPayments, a national repository of industry payments to physicians run by the Centers for Medicare & Medicaid Services.”
  • Per Fierce Healthcare,
    • “CVS Health is aiming to bolster the pharmacy workforce with new scholarship and tuition assistance programs for people looking to enter the field.
    • “The company’s new PharmD assistance program will be available to all graduates who intern with CVS as of April 30, according to an announcement, and they’re eligible to apply for an award of up to $20,000 applicable to their final year of tuition. 
    • “CVS said it plans to grow the program in the fall and will make it available to interns in their last two years of pharmacy training, offering up to $20,000 toward each of those years while they intern for the company. The program will also provide participants opportunities throughout the year to “obtain valuable experience before starting their post-graduate professional career in pharmacy,” CVS said.”

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.”

Thursday Miscellany

David Ermer–CDC, CMS, COVID-19, Medical / Rx research, Medicare, NCQA, No Surprises Act, Obesity, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Per HHS press releases, HHS issued the following proposed rules released today (links are to fact sheets);
    • a proposed rule to update Medicare payment policies and rates for the Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) for fiscal year (FY) 2025,
  • and
    • a proposed rule (CMS-1810-P) that would update Medicare hospice payments and the aggregate cap amount for fiscal year (FY) 2025,
  • and
    • “a proposed rule that would update Medicare payment policies and rates for skilled nursing facilities under the Skilled Nursing Facility Prospective Payment System (SNF PPS) for fiscal year (FY) 2025.” 
  • Here is the fact sheet for the Departments of Health and Human Services (HHS), Labor, and the Treasury (collectively, the Departments) final rules regarding short-term, limited-duration insurance (STLDI) and independent, noncoordinated excepted benefits coverage under the Affordable Care Act released today. 
  • Per the American Medical Association News,
    • The Office of Management and Budget March 28 released its final updated standards for Federal agencies on maintaining, collecting and presenting data on race and ethnicity. Last updated in 1997, the revised Statistical Policy Directive Number 15 is the product of an OMB Interagency Technical Working Group on Race and Ethnicity Standards. While SPD 15 does not mandate race and ethnicity data collection by federal agencies, it requires federal agencies to adhere to standardized data definitions, collection and presentation practices wherever they do collect or use such data. Among other changes, the revised SPD 15 requires that race and ethnicity be collected using a single question with multiple responses, superseding OMB’s previous requirement to collect Hispanic ethnicity as a separate question. In addition, SPD 15 adds a category for Middle Eastern or North African (MENA) as a minimum reporting category and requires federal agencies to collect more detailed information on race and ethnicity beyond the seven minimum reporting categories. However, agencies may request and receive exemptions from OMB in instances where the potential benefit of more detailed data do not justify the additional burden to the agency or the public, or where the collection of more detailed data would threaten privacy or confidentiality. 
    • The updated SPD 15 is effective immediately. However, federal agencies have until March 28, 2029, to bring existing data collection and reporting activities into compliance with the updated SPD 15 and must submit action plans to OMB on how they will comply with the requirements by Sep. 28, 2025.
  • OPM made a passing reference to this guidance today on the second day 0f the OPM carrier conference.
  • The Labor Department’s Office of Federal Contractor Compliance Programs issued “Updated Annual Hiring Benchmark and New Benchmark Resources” for the veteran’s affirmative action in employment law that applies to FEHB carriers.

From the public health and medical research front,

  • Mercer discusses weight management in the era of GLP-1 drugs.
  • The NIH Director, in her blog, points out that an “Immune Checkpoint Discovery Has Implications for Treating Cancer and Autoimmune Diseases.”
  • The Washington Post reports,
    • “Diabetes, air pollution and alcohol consumption could be the biggest risk factors for dementia, study has found.
    • “Researchers compared modifiable risk factors for dementia — which is characterized by the impairment of memory, thinking and reasoning — and studied how these factors appear to affect certain brain regions that are already particularly vulnerable to Alzheimer’s disease and schizophrenia.
    • “The research, based on brain scans of nearly 40,000 adults, between ages 44 and 82, in Britain was published Wednesday in Nature Communications.”
  • Health Day informs us,
    • “Some folks struggling with obesity appear to be hampered by their own genes when it comes to working off those extra pounds, a new study finds.
    • “People with a higher genetic risk of obesity have to exercise more to avoid becoming unhealthily heavy, researchers discovered.
    • “Genetic background contributes to the amount of physical activity needed to mitigate obesity. The higher the genetic risk, the more steps needed per day,” said senior researcher Douglas Ruderfer, director of the Center for Digital Genomic Medicine at Vanderbilt University Medical Center in Nashville, Tenn.”
  • MedPage Today lets us know,
    • “For adults who are immunocompromised, the updated 2023-2024 COVID-19 vaccine reduced risk of hospitalization compared with not getting the shot, according to CDC data.
    • “Vaccine effectiveness against hospitalization was 38% in the first 7 to 59 days after receipt of the updated monovalent XBB.1.5 COVID vaccine, and 34% in the 60 to 119 days after receipt, reported Ruth Link-Gelles, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, and colleagues in the Morbidity and Mortality Weekly Report.
    • “However, despite the positive effect, only 18% of people in this high-risk population had received the updated COVID vaccine, “representing a missed opportunity to prevent severe COVID-19,” the authors wrote.”
  • Medscape notes,
    • “Starting an exercise regimen with others can be a powerful fitness motivator, and new research spotlights the strategy’s particular importance for older adults.
    • “In a randomized clinical trial in JAMA Network Open, older adults who talked with peers about their exercise program were able to increase and sustain physical activity levels much better than those who focused on self-motivation and setting fitness goals.
    • “Such self-focused — or “intrapersonal” — strategies tend to be more common in health and fitness than interactive, or “interpersonal,” ones, the study authors noted. Yet, research on their effectiveness is limited. Historically, intrapersonal strategies have been studied as part of a bundle of behavioral change strategies — a common limitation in research — making it difficult to discern their individual value.
    • “We’re not saying that intrapersonal strategies should not be used,” said study author Siobhan McMahon, PhD, associate professor and codirector of the Center on Aging Science and Care at the University of Minnesota, in Minneapolis, Minnesota, “but this study shows that interpersonal strategies are really important.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The first major U.S. health insurers have agreed to start paying for the popular anti-obesity drug Wegovy for certain people on Medicare with heart-related conditions.
    • “CVS Health,  Elevance Health, and Kaiser Permanente said they would cover 
    • “Novo Nordisk’s Wegovy for the use of reducing the risk of heart attacks and strokes in people who have cardiovascular disease, meet body-weight criteria and are covered by a Medicare drug-benefit plan.
    • “Elevance, which operates many Blue Cross and Blue Shield health plans, also said it would extend coverage to people insured by a commercial plan.
    • “Some of the plans, including Kaiser Permanente’s, are making the coverage change effective immediately, while others, including those served by Elevance, will do so in the coming weeks.”
  • Axios informs us,
    • “The federal process for resolving billing disputes for out-of-network care has to date yielded payouts well above what Medicare and most in-network private insurers would pay providers, according to a new Brookings Institution analysis provided first to Axios. 
    • “Why it matters: That could lead to downstream effects like higher premiums — quite the opposite of what Congress intended when it passed a law banning surprise medical bills in 2020.
    • “What they found: Brookings analyzed Centers for Medicare and Medicaid Services data on arbitration decisions to settle disputed claims during the first half of 2023. 
    • “Researchers specifically focused on emergency care, imaging and neonatal and pediatric critical care.
    • “Across the three categories, median payouts were at least 3.7 times what Medicare would pay, Brookings found. 
    • “For emergency care and imaging, the median decision was at least 50% higher than the most generous payments commercial plans historically made, on average, for in-network care. 
    • “Similar estimates weren’t available for neonatal and pediatric critical care.
    • “The analysis concludes that there is a “realistic possibility” that the law will wind up raising in-network prices and, in turn, premiums.
    • “That’s the opposite of what the Congressional Budget Office predicted would happen.”
  • Interesting study but its conclusion is undercut by the fact that many providers accept the qualifying payment amount the the plans initially pay under the No Surprises Act.
  • Per Healthcare Dive,
    • Walgreens reported an almost $6 billion net loss in the second quarter, according to financial results released Thursday. Nearly all of that sum was attributable to the declining value of a single play: VillageMD, the primary care chain into which Walgreens has poured billions of dollars, but which has generated disappointing returns to date.
    • Walgreens was forced to write down VillageMD’s value after its financial team flagged a mismatch in the subsidiary’s value as recorded in its balance sheet and its value in the market, CFO Manmohan Mahajan told investors on a Thursday morning call. That discrepancy led Walgrens to record a $5.8 billion goodwill impairment charge.
  • and
    • “UCI Health has completed its $975 million purchase of four Southern California hospitals from Tenet Healthcare, the academic health system said Tuesday. Tenet announced the sale in February as part of an ongoing effort to fund debt repayment.”
  • and
    • “Ascension has signed a definitive agreement to divest three hospitals and an ambulatory surgical center in northern Michigan to MyMichigan Health, the health systems said Tuesday. 
    • “The deal includes Ascension St. Mary’s in Saginaw, Ascension St. Joseph in Tawas City, Ascension St. Mary’s in Standish and ambulatory surgery center and emergency department Ascension St. Mary’s Towne Center in Saginaw. Related care sites and physician practices are also included. 
    • “Ascension has recently sold other hospitals as the nonprofit expands its ambulatory and telehealth footprint.”

Midweek Update

David Ermer–Congress, Federal employment benefits, Medicare, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • From a Senate press release,
    • Today, Senator Rick Scott and Senator Tom Carper announced the bipartisan FEHB Protection Act to stop fraud within the Federal Employee Health Benefits (FEHB) program, the largest employer-sponsored health insurance program in the country which covers eight million federal employees, retirees and family members. The FEHB Protection Act will codify Government Accountability Office (GAO) and Office of Inspector General (OIG) recommendations to require the Office of Personnel Management (OPM) to verify eligibility before adding family members, additionally, the bill requires an audit and removal of those ineligible for the program to ensure taxpayer dollars are used wisely and program benefits are protected for truly eligible individuals. This legislation follows a study conducted by the GAO at Senator Scott’s request, which revealed that OPM’s mismanagement of the FEHB program allowed ineligible individuals to obtain employer-sponsored health coverage at the hefty price tag of approximately $1 billion in taxpayer dollars every year.
    • The FEHBlog doubts the accuracy of GAO’s projection because half of the FEHB enrollment is self only and FEHB family sizes are notoriously small. In any case, this approach will not solve the problem because OPM reports enrollment actions and premiums separately even though using the HIPAA 820 electronic enrollment roster transaction would allow carriers to confirm receipt of premium for each enrollee systematically.
  • From the American Hospital Association News,
    • The Centers for Medicare & Medicaid Services March 27 finalized a rule proposed in 2022 to standardize Medicaid and CHIP enrollment and renewal processes and make it easier for eligible children and adults to stay covered. According to CMS, the final rule eliminates CHIP waiting periods, annual and lifetime coverage limits and the practice of locking children out of coverage if a family is unable to pay premiums; improves the transfer of children from Medicaid to CHIP when a family’s income rises; gives individuals at least 15 days to provide additional information when applying for the first time and 30 days to return documentation when renewing coverage; prohibits conducting renewals more often than every 12 months; and prohibits in-person interviews for older adults and those with disabilities. The rule takes effect 60 days after publication in the April 2 Federal Register.
  • and
    • The Centers for Medicare & Medicaid Services March 27 released the fiscal year 2025 proposed rule for inpatient rehabilitation facilities, which would update IRF payments by an estimated 2.8% overall (or $280 million) in FY 2025. This includes a 3.2% market basket update, which is reduced by a 0.4% productivity adjustment. IRF payments would be further decreased by an estimated $25 million due to the proposed update for outlier payments.
  • and
    • The Department of Health and Human Services’ Administration for Strategic Preparedness and Response and Centers for Medicare & Medicaid Services this week released a guide to health plan resources for health care providers impacted by the Change Healthcare cyberattack, including health plan contact information, noting in an accompanying letter that many providers continue to face significant disruptions as a result of the cyberattack or difficulty getting information from health plans about prospective payments and other flexibilities. The letter also encourages providers to review HHS’ voluntary cybersecurity performance goals.
  • It is worth adding that the United Healthcare Group updated its Change Healthcare Cyberattack response page today.

From the public health front,

  • The Washington Post reports,
    • “On Monday, government leaders in Puerto Rico declared a dengue epidemic after a spike in cases of the mosquito-borne disease hit the island.
    • “From the start of the year through March 10, there were 549 cases, including 341 hospitalizations and 29 severe cases, according to the most recent data provide by the Puerto Rico Department of Health. Cases are concentrated in cities including San Juan, Bayamon, Guaynabo and Carolina.
    • “Between 2010 and 2020, more than 30,000 dengue cases were reported from four U.S. territories, with Puerto Rico reporting the most. In 2012, Puerto Rico reported 199 deaths, which was the last time the commonwealth declared a dengue epidemic.”
  • The Wall Street Journal ponders,
    • “How closely should you be tracking your blood-sugar levels? * * *
    • “Soon, people without diabetes will be able to buy a monitor without needing to cajole a doctor into prescribing them one. The Food and Drug Administration recently approved the over-the-counter sale of a continuous glucose monitor, also known as a CGM. The devices allow people to continuously monitor their blood sugar levels.
    • “People who obsess over their health data or have an unhealthy relationship with food should avoid CGMs, most doctors say. Users might misinterpret normal glucose fluctuations as unhealthy, causing anxiety and prompting them to restrict certain foods. It isn’t clear that healthy patients would benefit from using a CGM over the long term.
    • “However, people at higher risk of developing diabetes, and those who are interested in working with their doctors to make lifestyle changes, might find it helpful. The technology could spot early signs of insulin resistance, possibly helping otherwise healthy people avoid Type 2 diabetes, some doctors say. 
    • “If we identify these patients sooner, we can suggest lifestyle modifications as well as maybe the initiation of weight-loss medications,” says Dr. Brenda Dorcely, an endocrinologist at NYU Langone Health.” 

Tidbits from the OPM FEHB carrier conference

  • The FEHBlog attended OPM’s virtual FEHB carrier conference today. Here are some tidbits.

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Beleaguered health system Steward Health Care has agreed to sell its physician network, Stewardship Health, to healthcare behemoth UnitedHealth Group for an undisclosed sum, according to documents filed with Massachusetts regulators on Tuesday.
    • “Under the deal, UnitedHealth’s care delivery subsidiary Optum Care would acquire Steward’s nine-state footprint of primary care providers and clinicians. It will also acquire all of Stewardship’s stock. 
    • “The Health Policy Commission, an independent Massachusetts agency tasked with monitoring state healthcare spending, will have 30 days to assess the potential impact of a Optum-Steward deal on healthcare costs, quality and access, HPC director David Seltz said in a statement. Already, some legislators and health M&A experts are urging a close review of the transaction, citing antitrust concerns.”
  • Per MedTech Dive,
    • “Johnson & Johnson is in talks to acquire Shockwave Medical, The Wall Street Journal reported Tuesday, citing people familiar with the matter.
    • “A deal could come in the next few weeks. However, the report noted that talks could fall through, or another company could pick up Shockwave. J&J and Shockwave both told MedTech Dive they do not comment on market rumors or speculation.
    • “Shockwave makes medical devices that break up calcium deposits in coronary arteries using sound pressure waves, a technique called intravascular lithotripsy (IVL).”
  • Beckers Payer Issues offers an interview with Aetna’s chief medical officer about managed care lessons from Medicaid to Medicare.

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.”

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.”

Tuesday Tidbits

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Generative AI, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, U.S. Healthcare–
Photo by Maddy Weiss on Unsplash

Happy First Day of Spring!

From Washington, DC,

  • The Wall Street Journal reports,
    • “Lawmakers who are finishing writing six annual spending bills have resolved a last-minute roadblock over border funding, setting the stage for Congress to review and approve the legislation on a tight timeline that could take them to the brink of a partial government shutdown this weekend. 
    • “Congressional negotiators late Monday reached a deal on the provisions within the Department of Homeland Security’s funding bill. That bill got caught in an 11th-hour tangle with the White House over border spending, which has become a top issue in many swing states during the 2024 presidential-election year.
    • “In a statement Tuesday morning, Speaker Mike Johnson (R., La.) said an agreement has been reached on the Homeland Security funds, and House and Senate committees have begun drafting bill text to be “prepared for release and consideration by the full House and Senate as soon as possible.”
    • “President Biden said Tuesday that a path on the remaining funding legislation had been finalized and he would sign the measure immediately when it gets to his desk.”
  • Per a House Budget Committee press release,
    • “Today, the House of Representatives advanced House Budget Committee legislation, H.R. 766, the Dr. Michael C. Burgess Preventative Health Savings Act (PHSA), to the Senate by a voice vote. 
    • “The historic accomplishment marks the first time in history that a bipartisan bill with sole Budget Committee jurisdiction has been brought to the Floor under a suspension of the House rules. * * *
    • “One of the major barriers to deploying modernized and innovative policies that would unequivocally curb the cost of health care is the antiquated process used for calculating congressional cost estimates on proposed health care legislation.
    • “Congressional scorekeepers have traditionally focused solely only on the short-term valuation of a policy rather than capturing the long-term economic impact.
    • “But today, with passage of H.R. 766, that changes. This bill seeks to improve the methodology of Congress’ broken budgetary process by providing policymakers with a more accurate cost estimate of the long-term cost savings from preventive health care policies.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced a new voluntary model that empowers primary care providers in eligible Accountable Care Organizations (ACOs) to treat people with Medicare using innovative, team-based, person-centered proactive care. A key part of the Biden-Harris Administration’s efforts to further promote competition in health care, the ACO Primary Care Flex Model (ACO PC Flex Model) will provide a one-time advanced shared savings payment and monthly prospective primary care payments (PPCPs) to ACOs. The advanced shared savings payments provide ACOs with needed resources and flexibility to cover costs associated with forming an ACO (where relevant) and administrative costs for required model activities. PPCPs will be distributed by ACOs to primary care practices, giving them improved resources and flexibility to provide care that best suits individuals’ needs.” * * *
    • “The ACO PC Flex Model is a five-year voluntary model that will begin on January 1, 2025. CMS is planning to select approximately 130 ACOs to participate in the model. Organizations interested in participating must first apply — either as new ACOs or renewing ACOs — to the Shared Savings Program. Shared Savings Program Applications are open May 20, 2024 – June 17, 2024. The ACO PC Flex Model Request for Applications (RFA) is planned to be released in the second quarter of 2024.
    • “For Frequently Asked Questions about the Primary Care Flex Model, please visit: https://www.cms.gov/priorities/innovation/innovation-models/aco-primary-care-flex-model/faqs.
    • “For a fact sheet on the model, please visit: https://www.cms.gov/files/document/aco-pc-flex-fs.pdf – PDF.”
  • Yesterday, HHS’s Office for Civil Rights offered guidance to HIPAA covered entities and business associates about their use of online tracking technologies.
    • “Compliance with the Security Rule helps lower the risk of unauthorized access to ePHI collected through a regulated entity’s website or mobile app that could lead to harm to individuals. Therefore, OCR is prioritizing compliance with the HIPAA Security Rule in investigations into the use of online tracking technologies. OCR’s principal interest in this area is ensuring that regulated entities have identified, assessed, and mitigated the risks to ePHI when using online tracking technologies and have implemented the Security Rule requirements to ensure the confidentiality, integrity, and availability of ePHI. OCR investigations are fact-specific and may involve the review of technical information regarding a regulated entity’s use of any tracking technologies. OCR considers all of the available evidence in determining compliance and remedies for potential noncompliance.”
  • The U.S. Preventive Services Task Force issued the following final recommendation today:
    • “For children and adolescents younger than 18 years without signs and symptoms of or known exposure to maltreatment: The evidence is insufficient to assess the balance of benefits and harms of primary care interventions to prevent child maltreatment. [Grade I]”
  • Beckers Payer Issues discusses what fifteen insurers and trade associations explored with Biden Administration officials yesterday about the Change Healthcare situation.
    • During the meeting, stakeholders discussed how progress has been made in reestablishing claims processing systems, though small, rural and safety-net providers specifically are still reporting issues with cash flow.
    • Many healthcare organizations will require third-party certification of Change’s cybersecurity before reconnecting to its systems, in which UnitedHealth was urged to provide a timeframe around. Payers were also asked to analyze their internal data to determine which providers need more support and to engage with them directly.
    • According to Reuters, payers said they would accelerate payments to Medicare and Medicaid providers, along with providing loans to Medicaid providers.”
  • Here is a link to the HHS readout from this meeting.
  • The U.S. Postal Service reminded its retirees with Part A only about the opportunity to enroll for Medicare Part B with no late enrollment penalty during a special enrollment period beginning April 1, 2024. The Postal Service is picking up the late enrollment penalty cost. This is a good deal.
    • “The one-time PSHB SEP is from April 1, 2024, to Sept. 30, 2024. Individuals eligible for the PSHB SEP will receive notification by U.S. Mail™ in March 2024.
    • “All required information must be returned in the envelope provided and postmarked by Sept. 30, 2024.”
  • The Food and Drug Administration announced,
    • “On Monday, the FDA launched a new portal for patients, consumers and health care professionals to report potential drug shortage issues directly into CDER’s NextGen system without creating a NextGen account. 
    • “Since 2017, NextGen has been a way for regulated industry to communicate with the FDA, including submitting information on shortages, discontinuations, and anticipated supply disruptions. Non-industry stakeholders without a NextGen account previously reported information about potential shortages to the FDA’s Drug Shortages Staff by email. The new public portal allows anyone to submit shortage information through an online form directly into NextGen.  
    • “Expanding access to NextGen’s shortage reporting beyond regulated industry will allow for greater consistency and ease of reporting by outside stakeholders, and greater efficiency in tracking and responding to these reports.” 

From the public health and medical research front,

  • MedPage Today informs us,
    • “Investigation of an early signal for stroke associated with COVID-19 bivalent vaccines turned into suspicion of high-dose or adjuvanted flu shots instead, based on a large U.S. population-based study.
    • “When researchers inspected a large Medicare database, they found no evidence of a significantly elevated risk for stroke at 1-21 days or 22-42 days after vaccination with either of the mRNA COVID vaccines distributed for the 2022-2023 respiratory season when compared with the 43-90 day control window, reported researchers led by Yun Lu, PhD, a statistician of the FDA in Silver Spring, Maryland.
    • “There was a significant excess of nonhemorrhagic stroke for people with concomitant administration of Pfizer-BioNTech’s bivalent vaccine plus a high-dose or adjuvanted influenza vaccine during the 22-42 days risk window (risk difference of 3.13 out of 100,000 doses); and a significant excess of transient ischemic attack for people with concomitant administration of Moderna’s bivalent COVID vaccine plus a high-dose or adjuvanted influenza vaccine during the 1-21 days risk window (risk difference of 3.33 out of 100,000 doses).
    • “But the researchers found that people with administration of a high-dose or adjuvanted influenza vaccine alone (without concomitant COVID vaccination) had an elevated risk for the combined outcome of nonhemorrhagic stroke or transient ischemic attack in both the 1-21 days risk window (risk difference of 1.65 per 100,000 doses) and 22-42 days risk window (risk difference of 1.60 per 100,000 doses).
    • “This finding suggests that the observed association between vaccination and stroke in the concomitant subgroup was likely driven by a high-dose or adjuvanted influenza vaccination,” the investigators reported in JAMA.”
  • Medscape lets us know,
    • “The US Food and Drug Administration (FDA) has cleared the twiist automated insulin delivery (AID) system (Sequel Med Tech, LLC; Manchester, NH) for people aged 6 years or older with type 1 diabetes. 
    • “The system comprises a novel insulin pump developed by Sequel’s research and development partner DEKA and uses the FDA-cleared Tidepool Loop algorithmthat was originally developed through patient-led, open-source initiatives.
    • “The twiist AID system has the capacity to work interchangeably with different integrated continuous glucose monitors (iCGMs), and Sequel will announce their initial iCGM partner closer to market launch, Sequel CEO and co-founder Alan Lotvin, MD, told Medscape Medical News. 
    • “It is the first AID system that directly measures volume and flow of insulin delivery, which enables it to rapidly detect obstructions or occlusions, usually within about 20 minutes, Lotvin explained. “

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Elevance Health has inked a deal to acquire Kroger Specialty Pharmacy.
    • “The grocery chain announced Monday that an agreement is in place, saying it’s expected to close in the back half of 2024 pending regulatory approvals. Elevance intends to add Kroger Specialty Pharmacy to its CarelonRx business, which houses its pharmacy benefit management services.
    • “Financial terms of the sale were not disclosed.”
  • Per BioPharma Dive,
    • “AstraZeneca is the latest large pharmaceutical company to make a sizable bet on radiopharmaceutical drugs for cancer, agreeing on Tuesday to acquire longtime biotechnology partner Fusion Pharmaceuticals in a deal worth up to $2.4 billion.
    • “AstraZeneca will acquire all of Fusion’s shares for $21 apiece, or about $2 billion. The British drugmaker could add another $3 per share via a financial instrument known as a “contingent value right” if Fusion meets an unspecified regulatory milestone. Should Fusion hit that mark, the buyout would be worth $2.4 billion.” 
  • Beckers Health IT offers six takeaways from last month’s HIMSS conference.

Happy Pi Day!

David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, Medicare, Rx coverage–
Photo by Taso Katsionis on Unsplash

From Washington, DC

  • The bipartisan leadership of the Senate Finance Committee are pressing Congress for prescription benefit manager reform.
    • Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo R-Idaho, today renewed their call for the passage of their bipartisan legislation to crack down on pharmacy benefit managers (PBMs) and their shadowy tactics that are driving up the cost of prescription drugs and forcing pharmacies across the country to close their doors.
    • Ahead of a press conference this morning where Senators Wyden and Crapo were joined by pharmacy and patient advocates to press for PBM reform, the Senators sent a letter to their Finance Committee colleagues reaffirming their commitment to getting their legislation across the finish line as soon as possible this Congress.
  • FEHBlog observation — Read this Brookings Institution article to understand why the Senator’s position may be overwrought.
  • STAT News reports,
    • “Novo Nordisk’s newly won permission to market the heart benefits of its obesity drug Wegovy could provide a backdoor way to expand access to the drug for people on Medicare, experts told STAT.
    • “Currently, Medicare is prohibited by law from covering medications for obesity treatment alone. While companies that manufacture wildly popular anti-obesity medications and their allies haven’t been successful in lobbying Congress to change the law, the Food and Drug Administration’s move could give doctors an avenue to prescribe the medications to some Medicare patients.
    • “Wegovy’s new label indicates that the drug can be used to reduce the risk of major heart complications for people who are overweight or obese and have existing heart disease, Novo said in a statement Friday.
    • “This is definitely… an opportunity for patients with both cardiovascular disease and obesity to potentially get this drug when they couldn’t get it just for obesity alone,” said Juliette Cubanski, deputy director of the Program on Medicare Policy at KFF.”
  • MedPage Today tells us,
    • “The FDA granted accelerated approval to resmetirom (Rezdiffra) as the first treatment for adults with noncirrhotic non-alcoholic steatohepatitis (NASH), also now referred to as metabolic dysfunction-associated steatohepatitis (MASH).
    • “A once-daily oral agent, resmetirom is a liver-directed thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH; the drug is specifically indicated for NASH patients with moderate to advanced liver fibrosis, consistent with stages F2 to F3 fibrosis, and should be used along with diet and exercise, according to the agency.
    • “Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage,” said Nikolay Nikolov, MD, of FDA’s Center for Drug Evaluation and Research, in a statement. “Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise.”
    • “A result of non-alcoholic fatty liver disease (NAFLD) progression, NASH can lead to liver fibrosis and dysfunction, raising the risk of transplant and hepatocellular carcinoma. The condition is often associated with hypertension and diabetes.
    • “According to some estimates, 6 million or more Americans have NASH with stages F2 to F3 fibrosis, a number only expected to increase in the coming years.”
  • Healthcare IT News fills us in on an interesting conversation between the Deputy Coordinator of Health Information Technology and the CDC Director at the HIMSS conference in Orlando.

From the public health and medical research front,

  • The New York Times reports,
    • “Teen pregnancy increases the chances that a young woman will drop out of school and struggle with poverty, research has shown. Teenagers are also more likely to develop serious medical complications during pregnancy.
    • “Now a large study in Canada reports another disturbing finding: Women who were pregnant as teenagers are more likely to diebefore their 31st birthday. The trend was observed among women who had carried teen pregnancies to term, as well as among those who had miscarried.
    • “The younger the person was when they became pregnant, the greater their risk was of premature death,” said Dr. Joel G. Ray, an obstetric medicine specialist and epidemiologist at St. Michael’s Hospital in Toronto and the first author of the study. It was published in JAMA Network Open on Thursday.
    • “Some people will argue that we shouldn’t be judgmental about this, but I think we’ve always known intuitively that there’s an age that is too young for pregnancy,” he added.
  • The Washington Posts informs us,
    • “A new study calls into question the extent of the maternal mortality crisis in the United States, which has long posted a disproportionately high rate of maternal deaths compared with peer nations.
    • “Data classification errors have inflated U.S. maternal death rates for two decades, according to the study published Wednesday in the American Journal of Obstetrics & Gynecology. Instead of the maternal death rate more than doubling since 2002, it has remained flat, researchers found.
    • “There has been a lot of alarm and apprehension surrounding the fact that some of these reports show a threefold increase in maternal mortality, and that is not what we found. We found low and stable rates,” said K.S. Joseph, the study’s lead author and professor in the departments of obstetrics and gynecology and the School of Population and Public Health at the University of British Columbia in Vancouver. * * *
    • “Some experts say the study’s biggest takeaway is the persistent racial disparities, with many pregnant Black people experiencing more medical complications involving Caesarean sections, postpartum hemorrhaging and preterm births. However the data is calculated, the pattern remains the same, said Colleen Denny, an associate professor in the department of obstetrics and gynecology and director of family planning at NYU Langone Hospital as well as a fellow of the American College of Obstetricians and Gynecologists.
    • “We should be targeting a lot of our public outreach to focus on conditions that are affecting patients of color while they’re pregnant,” said Denny, who was not involved with the study.”

From the cybersecurity front,

  • UHC updated its Change Healthcare cyberattack response website today.
    • “Palo Alto Networks Unit 42 experts are on the ground, collaborating diligently with UnitedHealth and their partners to restore operations and ensure a swift and secure resolution following the recent disruption. To date we have reviewed and protected a large majority of infrastructure, including the server and application space, and assisted in bringing critical services back online that allowed for more than 9 million prescriptions to be filled.” 
  • The American Hospital Association News lets us know,
    • “The Centers for Medicare & Medicaid Services March 13 released additional information on the Medicare accelerated and advance payments that hospitals, physicians and others impacted by the Change Healthcare cyberattack may apply for through their Medicare Administrative Contractors. According to CMS, the MACs aim to review requests and notify most providers/suppliers of the outcome of their request within five business days of receipt.
  • Aetna provides a good example of the information that other carriers are sharing with their network providers and members about the Change Healthcare situation.

From the U.S. healthcare business front,

  • EBRI offers new research about health savings accounts.
    • “HSA balances continued to increase over the course of the year, despite higher spending on health care. Continuing a trend observed post-COVID-19 pandemic, patient spending on health care increased in 2022. Still, average end-of-year HSA balances were higher than average beginning-of-year balances. Average balances increased at an even faster rate in 2022, conditional on those accounts receiving either an employee or employer contribution over the course of the year. 
    • “Accounts that received an employer contribution saw higher total contributions and were more likely to invest. Employers seeking to help their workers engage with their HSAs may find employer contributions to be a useful tool, as accountholders who received an employer contribution on their behalf had higher average total contributions and were more likely to invest. Our analysis indicates, however, that these accountholders were also more likely to take more frequent and larger distributions. 
    • “Most accountholders took a distribution in 2022. More than half of the HSAs in EBRI’s database saw a distribution in 2022, and the average distribution was $1,868. 
    • “Relatively few HSAs are invested. One of the largest advantages HSAs offer is the ability to invest assets within the account. However, our analysis reveals that only 13% of accountholders invested their HSAs in assets other than cash. 
    • “Age and tenure play a major role in HSA utilization. Consistent with previous findings, accountholder age — as well as accountholder tenure — is closely related to average balances, contributions, and distributions, as well as the propensity to invest. On average, older accountholders contributed more to their HSAs, had higher balances, more frequently took distributions, and had a higher likelihood of investing at least some portion of their HSA in assets other than cash.”
  • McKinsey and Co. shares its report on the future of Medicare Advantage.
    • “The Medicare Advantage program is undergoing its biggest shifts in more than two decades. Payers can take steps now to mount a strategic, agile response as the changes unfold.”

 

Tuesday Tidbits

David Ermer–COVID-19, Cybersecurity, Electronic health records, FDA, Generative AI, Medical / Rx research, Medicare, NIH, Obesity, OPM, Patient safety, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Because this is the FEHBlog, the lede tonight necessarily is OPM’s announcement naming the carriers who are currently prepared Postal Service Health Benefit Program benefit and rate proposals. Good luck to them all.
  • FedWeek notes,
    • “President Biden has issued an open letter to federal employees thanking them for their “tireless service on behalf of our country.”
  • and
    • “While seeking a January 2025 raise of 2 percent (see related story), the White House’s fiscal 2025 budget proposal cites several initiatives related to federal pay.
    • “In addition to year-to-year pay increases, the Administration is pursuing structural reforms to enhance the competitiveness of the Federal pay system,” it says.
  • Reg Jones, writing in Fedweek, fills us in on benefits available upon the death of a federal employee or annuitant.
  • The Department of Health and Human Services provided a readout from “Biden-Harris Administration Convening with Health Care Community Concerning Cyberattack on Change Healthcare. Leaders from HHS, White House, DOL, and the health care community convened to discuss ways to mitigate harms to patient and providers caused by the cyberattack.”
  • The Food and Drug Administration “advised consumers in Some Medicines and Driving Don’t Mix to make sure they know if their prescription or over-the-counter medication can cause side effects that may make it unsafe to drive. Most medications won’t affect consumers’ ability to drive safely or operate other heavy machinery, but some do.”
  • The Buck consulting firm points out why “maintaining creditable coverage may prove difficult for some employer sponsored plans in 2025.”
  • STAT News discusses the treatment impact of new federal methadone rules.
    • “The federal government is reforming methadone care for the first time in over two decades. But how far do the changes actually go?
    • “To many methadone clinics, the Biden administration’s recent refresh of the rules governing opioid treatment programs represents an unprecedented opportunity to offer care that is more compassionate and responsive to patients’ needs. To many patient advocates, however, it simply nibbles around the edges. 
    • “The reality is likely somewhere in between: It will depend, in large part, on whether state-level regulators embrace the changes, and whether individual clinics actually implement them. In reform-oriented states, and at patient-centered clinics, the new rules could make a world of difference for people seeking addiction treatment.” 
  • The Office of National Coordinator for Healthcare Information Technology, Micky Tripathi, in his blog, looks forward to “HTI-2 & ONC’s Commitment to Furthering the Vision of Better Health Enabled by Data.”

From the public health and medical research front,

  • BioPharma Dive reports,
    • “Roche’s experimental Alzheimer’s disease drug trontinemab showed “best-in-class” potential based on its ability to quickly clear clumps of amyloid protein from the brains of patients enrolled in a small clinical trial, the company said Monday.
    • “A majority of patients receiving the highest dose of the drug, which is specially designed to penetrate brain tissue, saw their amyloid levels drop below detectable levels after 12 weeks, Roche executives said in an investor presentation on the pharmaceutical giant’s neurology pipeline.”
  • Reuters tells us, “Pfizer  said on Tuesday its drug, Adcetris, extended survival in patients with the most common type of lymphoma in a late-stage study, bolstering efforts to expand the use of the treatment gained through its $43 billion purchase of Seagen [in 2023].
  • MedPage Today lets us know,
    • “Pragmatic implementation of an automated online behavioral obesity treatment program that included 9 months of active maintenance helped people with overweight or obesity lose a clinically significant amount of weight by 12 and 24 months, a randomized trial showed. * * *
    • “This pattern persisted at 24 months, reported J. Graham Thomas, PhD, of the Weight Control and Diabetes Research Center in Providence, Rhode Island, and colleagues in JAMA Internal Medicine.
    • “This study shows that a fully automated online obesity treatment program can produce beneficial results for many patients in real-world primary care settings,” Thomas told MedPage Today. “We were encouraged to find that the online weight-loss program performed just as well in real-world primary care practices as it does in our previous highly controlled clinical trials.”
    • “These patients lost weight “at rates comparable” to those seen in studiesopens in a new tab or window in which the researchers were completely hands-on in every aspect of the program, he added.
    • “Because the treatment program is online and fully automated, Thomas said it is quite practical for widespread implementation across primary care practices. “The data show that the primary care clinicians were able to implement the program independently, and patients were able to use it successfully.”
  • Beckers Hospital Review adds,
    • “Hospital transplant departments have strict cutoffs for patients with higher body mass indexes because of the increased risk of complications, but GLP-1s such as Ozempic and Wegovy are helping more patients be eligible for surgery. 
    • “Potential transplant donors and diabetic patients who otherwise would not be able to undergo surgery because of their BMI are now quickly dropping weight. Popular GLP-1s, including Ozempic, and GLP-1s and glucose-dependent insulinotropic polypeptides, such as Mounjaro and Zepbound, are dramatically helping these weight loss efforts.” 
  • Medscape cautions,
    • “Novo Nordisk’s CEO on Friday said the company was working with authorities in several countries to tackle counterfeit versions of its popular diabetes drug Ozempic, as new reports emerge of patient harm across the world.
    • “This is something we take very seriously,” Lars Fruergaard Jorgensen, CEO of the Danish drugmaker, told Reuters. * * *
    • “Jorgensen, echoing comments from the FDA’s Califf, also said compounded semaglutide in the United States was a serious health issue, and that the raw materials, or active pharmaceutical ingredients (API), for these products were coming from unregulated facilities in Asia and elsewhere. 
    • “We don’t know them, and we have really no insights or ability to understand what the API is in a certain compounded product,” he said.
    • “While fake drugs often do not contain any of the medication advertised, compounded drugs are custom-made medicines that are based on the same ingredients as branded drugs. Because Wegovy and Ozempic are in short supply, they can be legally produced by licensed pharmacies in the U.S.
    • “Further reports obtained by Reuters through FOIA requests show that one person died last year from abnormal blood clotting after taking a drug that was advertised as compounded semaglutide. Three others suffered severe vomiting and nausea, sensory loss in their legs, and a drop in blood platelet levels.”
  • The U.S. Census Bureau announced,
    • “An additional 573,000 people died in the United States during the first year of the COVID-19 pandemic but “excess mortality” at the national level masks substantial variations by state, age, sex, and race and ethnicity, according to new U.S. Census Bureau research recently published in Demography.
    • “Excess mortality” refers to deaths from any cause above what is expected from recent mortality trends.
    • “This research shows the pandemic widened the mortality gap between the nation’s Black and White populations and completely erased the mortality advantage of the Hispanic population in relation to the non-Hispanic White population.”
  • The National Institutes of Health announced‘,
    • “Two phase 2 clinical trials to test the safety and effectiveness of three treatments for adults with autonomic nervous system dysfunction from long COVID have begun. The autonomic nervous system acts largely unconsciously and regulates bodily functions, such as heart rate, digestion and respiratory rate. Symptoms associated with autonomic nervous system dysfunction have been among those that patients with long COVID say are most burdensome. The trials are part of the National Institutes of Health’s Researching COVID to Enhance Recovery (RECOVER) Initiative, a nationwide research program to fully understand, diagnose and treat long COVID. Other RECOVER phase 2 clinical trials testing treatments to address viral persistence and neurological symptoms, including cognitive dysfunction (like brain fog), launched in July 2023. * * *
    • “People 18 years of age and older who are interested in learning more about these trials can visit https://trials.RECOVERCovid.org/autonomic or ClinicalTrials.gov and search identifier NCT06305793, NCT06305806 and NCT06305780. Please do not contact the NIH media phone number or email to enroll in these trials.”
  • The Wall Street Journal warns,
    • “Ultra-processed foods may not only affect our bodies, but our brains too.
    • “New research suggests links between ultra-processed foods—such as chips, many cereals and most packaged snacks at the grocery store—and changes in the way we learn, remember and feel. These foods can act like addictive substances, researchers say, and some scientists are proposing a new mental-health condition called “ultra-processed food use disorder.” Diets filled with such foods may raise the risk of mental health and sleep problems. 
    • “The science is still early and researchers say there is a lot they don’t know. Not all ultra-processed foods are equal, some scientists say, adding that some might be good for you. A diet high in ultra-processed foods has been linked with obesity, Type 2 diabetes, cancer and cardiovascular disease, but researchers are still figuring out exactly why, beyond calorie counts and nutrient composition. 
    • “Makers of foods such as processed meats and muffins defend their products, and note that there isn’t a consistent, universally accepted definition of ultra-processed food.”

From the HIMSS Conference in Orlando,

  • HIMSS offers an article about “Google Cloud’s debut of new genAI advancements for healthcare at HIMSS24. In total, the company is offering its cloud clients updates to Vertex AI Search, Healthcare Data Engine and MedLM, designed to improve patient care.”

From the U.S. healthcare business front,

  • HR Dive reports,
    • “Nearly half of U.S. workers don’t have the benefits they need at work, according to the results of a survey by Perceptyx, an employee experience company. Of the 1,500 full-time employees surveyed, 59% said they had “benefits envy” of friends’ and family members’ healthcare coverage.
    • “When it comes to benefits equity, the survey found that medical, maternity and mental health are the “magic trifecta,” Emily Killham, senior director of people analytics, research and insights at Perceptyx, said. “When employees have access to all three, women and men feel equally that their needs are met.”
    • “Yet 53% of those surveyed said they don’t have mental health coverage, 51% don’t have maternity leave, and 25% don’t have any medical benefits, per the results.”
  • Beckers Hospital Review informs us,
    • “Healthgrades recognized 832 hospitals with its 2024 Patient Safety Excellence Awards and Outstanding Patient Experience Award. Only 79 of those hospitals received both awards. 
    • “The dual recipients spanned 27 states. Texas had the most dual recipients with 13 honorees — including four Baylor Scott and White Health and four Houston Methodist hospitals.”
    • The article lists the dual recipients.
  • Beckers Payer Issues relates,
    • “Selective contracting with primary care physicians may be one factor behind lower per-patient expenses in Medicare Advantage, a study published in the March edition of Health Affairs found. 
    • “The study examined 4,456,037 traditional Medicare patients who visited 151,679 primary care physicians. The physicians who participated in Medicare Advantage networks had $433 lower costs per patient than the regional average of physicians. 
    • “The quality measures for physicians participating in Medicare Advantage were similar to the regional average, the study found. 
    • “Physicians who did not participate in any MA networks cost $1,617 more per patient per year than those participating in MA networks, and they had lower quality measures. 
    • “The findings suggest that “managed care tools, particularly selective contracting with primary care physicians” contribute to lower costs in Medicare Advantage, the authors concluded. Though the differences in cost are most likely attributable to differences in practice style, that could also serve as a mechanism for plans to select healthier patients, the authors wrote.” 
  • Health Payer Intelligence adds,
    • “The average Medicare Advantage premium has remained low and stable, with many beneficiaries choosing plans with a zero-dollar monthly premium, according to data from eHealth, Inc.
    • “eHealth’s seventh annual Medicare Index Report includes data from over 190,000 applications for Medicare insurance products submitted to eHealth during the annual enrollment period for 2024 coverage.
    • “The average monthly premium for Medicare Advantage plans chosen by eHealth customers for 2024 is $9, the same as last year and up slightly from $6 in 2022. The popularity of plans with zero-dollar premiums contributed to the low average.”
  • HealthDay informs us,
    • “The cost to American families of caring for a child with a mental health condition jumped by almost a third between 2017 and 2021.
    • “It now costs an average $4,361 more per year for a U.S. family to care for a child with a mental health condition, compared to families without such children, a new study has found.”