Midweek Update

CMS

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.”

Tuesday Tidbits

David Ermer–ACA, CMS, FDA, Generative AI, Medical / Rx research, Obesity, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Per HHS press releases
    • Today, the Biden-Harris Administration, through the U.S. Department of Health and Human Services (HHS)’s Centers for Medicare & Medicaid Services (CMS), announced policies for the Affordable Care Act Marketplaces that make it easier for low-income people to enroll in coverage, provides states the ability to increase access to routine adult dental services, and sets network adequacy standards for the time and distance people travel for appointments with in-network providers. Finally, the rule will standardize certain operations across the Marketplaces to increase reliability and consistency for consumers. The 2025 [ACA] Notice of Benefit and Payment Parameters final rule builds on the Administration’s previous work expanding access to quality, affordable health care and raising standards for Marketplace plans nationwide.
  • and
    • Today, the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) released new research showing how key Inflation Reduction Act provisions will lower costs for women enrolled in Medicare, including nearly 30 million women enrolled in Part D. Also, today, HHS announced that the Centers for Medicare & Medicaid Services (CMS) responded to counteroffers from all manufacturers participating in Medicare drug price negotiations – which the Inflation Reduction Act made possible – and invited them to participate in further discussions.
  • and
    • Today, the U.S. Department of Health and Human Services (HHS) released a white paper highlighting steps HHS has taken to prevent and mitigate drug shortages and proposing additional solutions for policymakers to consider. Drug shortages have occurred in the nation’s health care system for several decades, largely due to market failures and misaligned incentives. With today’s white paper, HHS offers solutions and stands ready to work with Congress to ensure no patient faces the devastating consequences of drug shortages or goes without needed medicines.
  • With respect to the 2025 Notice of Benefit and Payment Parameters, here is a link to the CMS fact sheet and a related ACA FAQ 66.
    • “FAQ 66 puts large group market plans (all FEHB plans are large market plans) and self funder ERISA plans on notice that the regulators will be subjecting these plans and the small group and individual market plans to a new rule applying the prohibition against lifetime and annual dollar limits to prescription drugs classified as essential health benefits.  
    • “Under the law, large group market and self funded ERISA plans must select a state benchmark to apply this limit to essential health benefits other than prescription drugs. For 2025, the EHB prescription drugs also must be considered.” 
  • CMS posted the Final 2025 Actuarial Value Calculator Methodology.
  • CMS also issued an update to its Section 111 Group Health Plan User Guide. The update seeks to prevent overlapping drug records.

From the public health and medical research front,

  • Health Affairs Forefront gives us access to “The CMS Innovation Center’s Strategy To Support Person-Centered, Value-Based Specialty Care: 2024 Update.”
  • STAT News reports,
    • “An AI algorithm to detect heart failure, embedded in a digital stethoscope, earned clearance from the Food and Drug Administration on Tuesday. The goal is to help primary care doctors more easily identify the often-hidden condition.
    • “The stethoscope is the result of a collaboration between Mayo Clinic researchers, who built the algorithm, and the startup Eko Health, which built the hardware. Mayo Clinic is an investor in Eko, which has raised $128 million over the past six years. Eko’s stethoscopes currently use two predictive AI algorithms: one for atrial fibrillation and one for structural heart murmur. The difference with heart failure, though, is how much more difficult it is for doctors to catch. 
    • Nearly 6.5 million Americans have heart failure, meaning their hearts are unable to pump blood properly. The illness is typically visible via heart ultrasounds, or echocardiograms, but these tests are expensive. Catching the condition early and non-invasively at a primary care checkup could save lives. 
    • “We’re moving from what’s human visible to what’s almost human invisible,” said Connor Landgraf, CEO of Eko Health. “The signals that we’re identifying in the heart sounds in an ECG are so subtle that humans wouldn’t even be able to pick them up.”
  • Beckers Hospital Review tells us,
    • “Among nearly 1 million patients who underwent upper or lower endoscopy procedures, those prescribed GLP-1s, such as Ozempic or Wegovy, were 33% more likely to experience aspiration pneumonia than other patients. 
    • “This finding was detailed in a study conducted by researchers at Los Angeles-based Cedars-Sinai. The risk of GLP-1 patients aspirating and regurgitating under anesthesia was first addressed in June 2023, when the American Society of Anesthesiologists recommended halting a patient’s last dose before an elective surgery. 
    • “The recommendation was based on anecdotal evidence at the time, and physicians across the U.S. soon implemented new perioperative workflows. Now, data from January 2018 through December 2020 shows an association between GLP-1 use and aspiration pneumonia, or pneumonia caused by foreign objects entering the lungs, according to a Cedars-Sinai news release.
    • “The researchers considered other variables that could affect surgery outcomes, the release said. Results were published March 27 in Gastroenterology.”
  • MedPage Today lets us know,
    • “A few simple interventions boosted flu vaccine uptake for patients waiting at the emergency department [ED], according to the cluster-randomized, controlled PROFLUVAXED trial.
    • “People in ED waiting areas who consented to view a 3-minute video with a scripted message, read a one-page flyer, and have a short discussion with an ED clinician about the flu vaccine had a 30-day follow-up vaccination rate of 41% versus 15% among patients that received no messaging about the vaccine.
    • “Even just asking people in the ED “Would you accept the influenza vaccine in the emergency department today if your doctor asked you to get it?” resulted in a 30-day vaccination rate of 32%, Robert Rodriguez, MD, of the University of California San Francisco, and colleagues reported in NEJM Evidence.”
  • The Washington Post and Consumer Reports discuss “What to know about 6 important blood tests for your health.”

From the U.S. healthcare business front,

  • Fierce Healthcare informs us,
    • “Kaiser Permanente’s Risant Health has closed its acquisition of Geisinger Health, notching the first step on its ambitious plan to form a multisystem, multiregional value-based care organization.
    • “Oakland, California-based Kaiser Permanente announced the deal alongside the formation of Risant Health and its broader strategy nearly a year ago. The acquisition has been approved by state and federal regulatory agencies and closed March 31, Kaiser Permanente said in a Tuesday release.
    • “Danville, Pennsylvania-based Geisinger, which runs 10 hospitals, was highlighted as an ideal inaugural partner for the budding value-based care platform due to the system’s experience running a roughly 600,000-member health plan.
    • “Through Risant Health, we will leverage our industry-leading expertise and innovation to increase the country’s access to high-quality and evidence-based health care, which we know improves care quality and the patient and member experience,” Kaiser Permanente CEO Greg A. Adams, who is also the board chair of Risant Health, said in Tuesday’s announcement. “We will also learn and benefit from Geisinger and the additional health systems that become part of Risant Health in the future, to help them grow in new ways, be more affordable and bring value-based care to more people.”
    • “Jaewon Ryu, M.D., Geisinger’s president and CEO since 2019, is now stepping into the role of Risant Health CEO, according to the announcement. Terry Gilliland, M.D., will fill Ryu’s post at Geisinger once the transition is complete.”
  • and
    • “Intermountain Health shuttered Saltzer Health, a multispecialty group the system acquired less than four years ago, after it failed to find a buyer for the provider.
    • “Based in southwest Idaho, Saltzer Health had been one of the state’s oldest and largest primary care groups. in operation for 63 years, the company had 450 employees and clinicians spread across 11 locations.” 
  • Per Biopharma Dive,
    • “Abbott said Tuesday it received the Food and Drug Administration’s approval to market a transcatheter device for repairing the tricuspid valve in patients who are unable to withstand open-heart surgery.
    • “The go-ahead from the FDA paves the way for Abbott’s Triclip repair system to compete in the U.S. against Edwards Lifesciences’ recently approved transcatheter tricuspid valve replacement device, Evoque.
    • “Triclip uses the same clip-based technology to treat tricuspid regurgitation as Abbott’s Mitraclip for mitral valve regurgitation, a device the company has credited with driving double-digit growth in its structural heart business.”
  • USA Today reports,
    • “Costco and its low-cost health care partner are expanding into weight-loss management.
    • “Costco will begin offering its members in the U.S. access to a weight loss program through Sesame, a health care marketplace, Sesame exclusively told USA TODAY. The service, which will cost $179 every three months, is scheduled to become available April 2.”
  • Medical Economist notes,
    • “Data exchange, or interoperability, among electronic health records (EHRs) is getting easier but still has a long way to go before primary care doctors are completely satisfied with it, a new study concludes. * * *
    • “Broken down by information type, the highest level of satisfaction—34%– was ability to receive lab reports from external organizations. The lowest level—21%—was for information on preventive care. Overall, 11% said they were not at all satisfied with at least half the information types they received, about 25% reported they were very satisfied with at least half the information types and 11% were very satisfied with all the information types.
    • “Fewer than one in ten (8%) said information from EHR developers different from their own was very easy to use, compared with 38% who said data from the same EHR developer was very easy to use.
    • “The authors say their findings highlight the need for different initiatives to improve interoperability depending on the challenges faced by different physician populations. For example, physicians serving vulnerable populations said they often lack the resources to address patients’ social needs, and thus could benefit from initiatives making it easier for them to join an exchange network.”
    • “Taken together,” they conclude, “these data suggest a need for diverse and targeted approaches to complete progress toward universal, high-value interoperability.”

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.”

Thursday Miscellany

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Update

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

   

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.

Friday Factoids

David Ermer–CDC, CMS, COVID-19, FDA, Generative AI, Medical / Rx research, NIH, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

Beware the Ides of March. Wm. Shakespeare

From Washington, DC,

  • STAT News reports
    • “A panel of expert advisers to the Food and Drug Administration on Friday voted in favor of expanding the use of CAR-T therapy in blood cancer, despite concerns about the powerful treatment’s side effects.
    • “The group voted 11-0 that the benefits of Carvykti, a CAR-T medicine from Johnson & Johnson and Legend Biotech, outweighed its risk for patients with multiple myeloma whose disease has persisted despite initial treatment. The same panel voted 8-3 in favor of Abecma, from Bristol Myers Squibb and 2seventy Bio, for multiple myeloma patients who’ve received at least two lines of therapy. Currently both medicines are approved only for patients who have been treated for myeloma with four or more medications.”
    • “In clinical trials, each drug proved to significantly delay disease progression compared to standard therapy. But zooming in on the data, the FDA observed an alarming imbalance of deaths in the early months of both studies, finding that more patients in the CAR-T group died of myeloma or side effects than those receiving the standard of care.
    • “That’s a legitimate concern, panelists said, but one that is outweighed by the potential for a single dose of CAR-T to help patients live without the need for regular, taxing cancer treatment.”
  • MedTech Dive notes,
    • “Intuitive Surgical said Thursday it received 510(k) clearance from the Food and Drug Administration for a fifth-generation robotic surgery system intended to help the company keep its dominant market share in the face of looming competition.
    • “The da Vinci 5 system incorporates features that surgeons have long sought, such as feedback that simulates the feel of the patient’s body tissue, a smaller physical footprint in the operating room, and better console ergonomics.
    • “The improvements “can help drive incremental demand for the system and raise the bar for competition in the future,” William Blair analyst Brandon Vazquez said Friday in a note to clients.”
  • One Digital offers its thoughts about “How will the Inflation Reduction Act of 2022 Impact Employer-Sponsored Group Health Plans in 2025?”
    • It’s not good news, and the FEHBlog doesn’t understand why CMS is making life so difficult for plan sponsors, e.g.,
      • “[T]he Centers for Medicare and Medicaid Services (CMS) released Draft CY 2025 Part D Redesign Program Instructions on January 31, 2024. These instructions, which are still in draft form, noted that one of the methods previously used by a majority of plan sponsors to determine the creditable nature of their plans, the creditable coverage simplified determination methodology, would no longer be a “valid method to determine whether an entity’s prescription drug coverage is creditable or not.”

From the public health and medical research front,

  • The Centers for Disease Control informs us,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is elevated across many areas of the country. This week, 16 jurisdictions experienced high or very high activity compared to 22 jurisdictions previous week.
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.
    • “Influenza test positivity increased slightly nationally. COVID-19 and RSV test positivity decreased compared to the previous week.
    • “Nationally, COVID-19 wastewater viral activity levels, which reflects both symptomatic and asymptomatic infections, has decreased to low.
    • “Reported on Friday, March 15th, 2024.“
  • STAT News gives us good news,
    • “A series of new studies are raising hopes that CAR-T, a process in which treatments are made by genetically editing a patient’s own white blood cells, can eventually be used to treat an incurable and deadly type of brain cancer, called glioblastoma multiforme, or GBM.
    • “In the most dramatic result, from a three-person study conducted by researchers at Massachusetts General Hospital, a 72-year-old man saw his tumor shrink 18.5% in just two days and then decrease further over the next two months until it was 60% smaller than when treatment began. That’s notable because glioblastoma is a cancer where drugs can normally only prevent a tumor from growing. Researchers say the results, published in the New England Journal of Medicine on Wednesday, do not mean the treatment is ready to be used widely but give reason to think they are on the right track.”
  • Healio calls our attention to a study on the benefits of bariatric surgery.
    • Bariatric surgery was associated with reductions in body weight, blood pressure, total cholesterol, triglycerides, glucose and HbA1c.
    • Adults who underwent surgery reduced their 10-year Atherosclerotic cardiovascular disease ASCVD risk by 34.4%.
  • The National Institutes of Health’s Director, in her blog, discusses a study suggesting that during sleep, a neural process helps clear the brain of damaging waste.
    • “We’ve long known that sleep is a restorative process necessary for good health. Research has also shown that the accumulation of waste products in the brain is a leading cause of numerous neurological disorders, including Alzheimer’s and Parkinson’s diseases. What hasn’t been clear is how the healthy brain “self-cleans,” or flushes out that detrimental waste.
    • “But a new study by a research team supported in part by NIH suggests that a neural process that happens while we sleep helps cleanse the brain, leading us to wake up feeling rested and restored. Better understanding this process could one day lead to methods that help people function well on less sleep. It could also help researchers find potential ways to delay or prevent neurological diseases related to accumulated waste products in the brain.
    • “The findings, reported in Nature, show that, during sleep, neural networks in the brain act like an array of miniature pumps, producing large and rhythmic waves through synchronous bursts of activity that propel fluids through brain tissue. Much like the process of washing dishes, where you use a rhythmic motion of varying speeds and intensity to clear off debris, this process that takes place during sleep clears accumulated metabolic waste products out.”

From the U.S. healthcare business front,

  • MedTech Dive lets us know,
    • “Most U.S. hospital executives expect low- to mid-single-digit increases in procedure volumes this year, according to a survey conducted by BTIG analysts.
    • “The forecast, which reflects the resolution of staff shortages at most surveyed sites and a small overall rise in capital equipment budgets, could benefit Boston Scientific, Medtronic and Stryker, the analysts wrote Wednesday in a note to investors.
    • “Robotic surgery jumped up the list of spending priorities, climbing from sixth to third place year over year. The change is a “good sign” for Intuitive Surgical, the analysts said, although the forecast of a continued slump in bariatric procedures has negative implications for the company.”
  • Per Fierce Healthcare,
    • “Medicare households are spending far more on healthcare than other households, according to a new KFF analysis.
    • “Researchers analyzed data from the 2022 Consumer Expenditure Survey, tracking spending trends between 2013 and 2022. At the end of that window, health-related expenses in Medicare households averaged $7,000, or 13.6% of total household spending.
    • “By comparison, non-Medicare households spent on average 6.5% of their total on health-related expenditures, or $4,900.
    • “Healthcare expenses included insurance premiums, medical services, prescription drugs and medical supplies like crutches, hearing aids and eyeglasses.”
  • From Healthcare IT News, a Gartner expert points to AI and hospital-at-home as the biggest emerging technologies at HIMSS24. Veronica Walk, senior director analyst, healthcare and life sciences, at the consulting giant offers an end-of-the-week look at the emerging technologies at the conference that provider organization C-suite executives must grasp. Check it out.
  • Fierce Healthcare discusses why payers and providers continue to tussle over Change Healthcare cyberattack response. Hint: The reason is money.

Midweek Update

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

From Washington, DC,

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

From the Change Healthcare situation front,

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

From the public health and medical research front,

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

From the HIMSS conference front,

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

In other U.S. healthcare business news,

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

Weekend Update

David Ermer–CDC, CMS, Congress, Cybersecurity, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

From Washington, DC,

  • Reuters adds, “U.S. President Joe Biden will put forth his proposed U.S. spending plan [tomorrow] March 11, according to the White House Office of Management and Budget.”
  • Today, the Department of Health and Human Services posted a letter to healthcare leaders about the Change Healthcare cyberattack.
    • We urge insurance companies and other payers to:
      • Make interim payments to impacted providers. Larger payers in particular have the balance sheet stability to advance payments. Payers have the opportunity to stop-gap the cash flow concerns by stepping in with bridge payments [FEHBlog note — assuming that the payer doesn’t rely on Change Healthcare for backend claims processing.}
      • In particular, for Medicaid plans, consider making interim payments to impacted providers.
      • Ease the administrative burden on providers by simplifying electronic data interchange requirements and timelines and by accepting paper claims. 
      • Pause prior authorizations and other utilization management requirements; use all available leeway on deadlines.
  • The Washington Post further reports,
    • “Federal health officials on Saturday said they would offer emergency funding to physicians, physical therapists and other professionals that provide outpatient health care, following a cyberattack that crippled the nation’s largest processor of medical claims and left many organizations in financial distress.
    • “The Centers for Medicare and Medicaid Services also announced that it would make advance payments available to suppliers that bill through Medicare Part B, which serves a wide array of health-care organizations. Officials had previously announced a similar program to make emergency payments available for hospitals that had been ensnared by the Feb. 21 hack of Change Healthcare, a unit of UnitedHealth Group, and have struggled to get paid for more than two weeks. The emergency funds represent upfront payments made to health-care providers and suppliers based on their expected future claims. * * *
    • “It’s going to help significantly,” added Farzad Mostashari, the CEO of Aledade, the nation’s largest network of independent physician practices. Mostashari had previously warned that as many as 25 percent of physician practices were in financial distress.”

From the public health and medical research front,

  • According to the Centers for Disease Control,
    • “Activity Levels Update:
      • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is elevated across many areas of the country. This week, 20 jurisdictions experienced high or very high activity compared to 26 jurisdictions previous week.
      • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.
      • “Influenza test positivity remained stable nationally. COVID-19 and RSV test positivity decreased compared to the previous week.
      • “Nationally, COVID-19 wastewater viral activity levels, which reflects both symptomatic and asymptomatic infections, has decreased to moderate.
    • “Reported on Friday, March 8th, 2024.“
  • Fortune Well offers advices on pregnancy in advance maternal age (at age 35 or older).
  • The Washington Post tells us,
    • “Tai chi, a gentle Chinese martial art involving slow movements, outperformed moderate aerobic exercise in lowering blood pressure in a recent clinical trial.
    • “An analysis, published in JAMA Network Open, tracked 342 18- to 65-year-olds with prehypertension, or blood pressure that is slightly higher than normal, between late July 2019 and mid-January 2022. * * *
    • “These findings support the important public health value of Tai Chi to promote the prevention of cardiovascular disease in populations with prehypertension,” the researchers conclude. Other research continues to explore the potential benefits of tai chi. The exercises are associated with better balance, fall reduction, and benefits for patients with conditions such as arthritis and fibromyalgia.”
  • Bloomberg discusses measles prevention practices for adults born after 1957.
    • “[Katrine Wallace, an epidemiologist at University of Illinois Chicago] says, adults are sufficiently protected from the measles if one of these four things applies to you:
      • “You had measles at some point in your life.
      • “You were born before 1957.
      • “You’ve had two doses of a measles-containing vaccine if you spend time in a high-risk setting for transmission, like schools or hospitals. 
      • Y”ou’ve had one dose of a vaccine if you don’t spend time in high-risk settings. 
      • “Kids and teens need one or two doses for protection depending on their age.” 
    • If you aren’t sure whether you’ve been vaccinated or had the measles, you can get what’s called an MMR titer test, which is available commercially at various labs for about $129, Wallace advises.
  • The Wall Street Journal delves into the development of individual body organ tests.
    • “Measuring organ age is the latest frontier in the world of biological age, the idea that your body’s physical age can be different from its chronological one. For example, a 50-year-old man hypothetically might have physical health that more closely resembles that of a 53-year-old, with, say, a 51-year-old heart and a 54-year-old brain.
    • “Knowing the age of your organs might one day help you prevent and treat disease. In theory, if you knew that your heart was aging too fast, you could take steps to ward off heart disease.
    • “Heart aging predicts future heart disease, and brain aging predicts future dementia,” says Hamilton Oh, one of the paper’s lead authors and a graduate student at Stanford.
    • “Walking into your doctor’s office and getting a simple test to determine your organ age is likely still a ways off, but the concept is gaining interest among researchers, doctors and people focused on their own longevity and health. Scientists caution that more research is needed before such a technology might be ready for mainstream use. Some also say that parts of the recent study made too many assumptions.”

From the U.S. healthcare business front,

  • The Dispatch informs us,
    • “A 2021 study published by the RAND Corporation found that, even after rebates and other discounts, U.S. prescription drug prices were, on average, nearly twice as high as those in countries including Canada, France, Germany, Japan, and the United Kingdom. A 2024 study, also conducted by the RAND Corporation for the Office of the Assistant Secretary for Planning and Evaluation, similarly found that 2022 drug prices in the U.S. were nearly three times higher than those in the 33 Organisation for Economic Co-operation and Development (OECD) countries used in the comparison.
    • “However, the study also found that, on average, unbranded generic drugs were about a third cheaper in the U.S. than in other comparison countries, meaning Americans are actually paying less for these drugs than they would elsewhere. “This finding suggests that robust price competition in U.S. unbranded generic markets continues to drive savings for consumers and health care payers relative to spending on these drugs in other countries,” the study said. Even though generic drugs make up 90 percent of U.S. prescription volume, the substantially higher cost for brand-name drugs still results in a higher average cost for all drugs in the U.S. than elsewhere, according to the report.”
  • HR Dive lets us know,
    • “Judge J. Campbell Barker of the U.S. District Court for the Eastern District of Texas vacated the National Labor Relations Board’s joint employer rule late Friday. The rule was set to go into effect Monday.
    • “The new rule would be “contrary to law” and “arbitrary and capricious,” Barker ruled. The court had been considering a legal challenge brought in November by the U.S. Chamber of Commerce, along with other business groups. 
    • “Federal agencies and employers now await a possible court decision on the U.S. Department of Labor’s independent contractor rule, also set to go in effect Monday.”