FEHBlog

Monday Roundup

David Ermer–Generative AI, NIH, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The FEHBlog travelled back to DC yesterday,
  • Per a Department of Health and Human Services press release,
    • “Today, the U.S. Department of Health and Human Services’ (HHS) Health Resources and Services Administration (HRSA) announced a combined investment of $15 million over four years through the Rural Maternity and Obstetrics Management Strategies (Rural MOMS) Program to improve maternal health in rural communities and a new program focused on strengthening maternal care and reducing disparities in the Delta region (within Alabama, Arkansas, Illinois, Kentucky, Louisiana, Mississippi, Missouri, and Tennessee). HRSA Deputy Administrator Jordan Grossman highlighted these strategic investments today in Flagstaff, AZ, during the third state convening of HRSA’s Enhancing Maternal Health Initiative.”
  • The NIH Director in her blog tells us,
    • The NIH Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative has expanded scientists’ understanding of the human brain in recent years, offering fascinating insights into the ways that individual cells and complex neural circuits interact dynamically to enable us to think, feel, and act. But neuroscientists still have much more to learn about how our brains are put together at the most fundamental, subcellular level.  
    • As a step in that direction, in a new study supported in part by the NIH BRAIN Initiative and reported in the journal Science , researchers have created the most detailed nanoscale resolution map ever produced of a cubic millimeter of brain tissue, about the size of half a grain of rice. * * *
    • While there is plenty still left to uncover, the findings offer proof-of-principle that it’s possible to visualize the brain at this very detailed level. This is crucial groundwork for new research now supported by the BRAIN Initiative Connectivity Across Scales (BRAIN CONNECTS) program. BRAIN CONNECTS will develop and scale up tools to produce an equally detailed map of a complete mouse brain, which is about 1,000 times larger than the human brain fragment. The researchers now hope their 3D map and others like it will be put to work to understand both normal and disordered brain function more fully.

From the public health and medical research front,

  • The AMA News lets us know what doctors wish their patients knew about the measles.
  • NIH announced.
    • “In a proof-of-concept study, researchers at the National Institutes of Health (NIH) have developed an artificial intelligence (AI) tool that uses routine clinical data, such as that from a simple blood test, to predict whether someone’s cancer will respond to immune checkpoint inhibitors, a type of immunotherapy drug that helps immune cells kill cancer cells. The machine-learning model may help doctors determine if immunotherapy drugs are effective for treating a patient’s cancer. The study, published June 3, 2024, in Nature Cancer, was led by researchers at the National Cancer Institute’s (NCI) Center for Cancer Research and Memorial Sloan Kettering Cancer Center in New York. NCI is part of the National Institutes of Health. * * *
    • “The researchers noted that larger prospective studies are needed to further evaluate the AI model in clinical settings. They have made their AI model, called Logistic Regression-Based Immunotherapy-Response Score (LORIS), publicly available at https://loris.ccr.cancer.gov. The tool estimates the likelihood of a patient responding to immune checkpoint inhibitors based on data on the six variables described above.”
  • Health Day tells us,
    • “About one in eight U.S. seniors will be treated for a traumatic brain injury, typically during a fall, a new study finds.” About one in eight U.S. seniors will be treated for a traumatic brain injury, typically during a fall, a new study finds.
    • “Medicare data shows that about 13% of seniors suffered a severe concussion during an average follow-up period of 18 years, researchers report.
    • “Although these injuries can be treated, they increase the risk of serious conditions like dementia, Parkinson’s disease, seizures, heart disease, depression and anxiety, they added.
    • “The number of people 65 and older with TBI is shockingly high,” said senior researcher Dr. Raquel Gardner, a neurologist with the Sheba Medical Center in Israel.”
  • Healio points out,
    • “Statin therapy was tied to a 5-year CVD risk reduction in adults aged 75 years and older.”Statin therapy was tied to a 5-year CVD risk reduction in adults aged 75 years and older.
    • “Statin use did not increase the risk for major adverse events, such as liver dysfunction.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Nonprofit hospital margins hit 4.3% in April, up 33% year over year, according to Kaufman Hall’s “National Hospital Flash Report” released June 3.”Nonprofit hospital margins hit 4.3% in April, up 33% year over year, according to Kaufman Hall’s “National Hospital Flash Report” released June 3.
    • “Kaufman Hall examined data from 1,300 hospitals in Syntellis Performance Solutions’ database and found that while hospital margins are improving overall, so is the gap between the highest and lowest performing hospitals. The best performing hospitals had a margin of 28.9%, compared to -16.1% for the worst performing hospitals. * * *
    • “Of note, the data revealed:
      • “1. Outpatient revenue increased 10% year over year in April.
      • “2. Average length of stay dropped 4% year over year in April.
      • “3. Emergency department visits increased to hit pre-pandemic levels.”
  • BioPharma Dive informs us,
    • “An experimental GLP-1 pill helped people with obesity lose significantly more weight than a placebo over three months, according to summary results revealed by developer Structure Therapeutics Monday.
    • “Structure’s drug led to an average reduction in body weight of 6.2% over placebo. One-third of those on the drug, dubbed GSBR-1290, lost 10% or more of their body weight, compared to zero of those given placebo.”
  • Per MedTech Dive,
    • “BD has agreed to buy Edward Lifesciences’ critical care group for $4.2 billion in cash, ending Edwards’ plan to spin off the business.
    • “In a Monday announcement, BD highlighted the group’s patient monitoring technologies and artificial intelligence-enabled clinical decision products that will add to BD’s existing businesses. Edwards’ critical care unit grew revenue by 8.5% year over year to $928.1 million in 2023.
    • “RBC Capital Markets analyst Shagun Singh said the deal would streamline Edwards. “Notably, the transaction creates a pure-play structural heart company positioning them for strategic initiatives that could further create shareholder value,” Singh wrote in a note to investors.”

Weekend Update

David Ermer–Congress, COVID-19, Medical / Rx research, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Washington, DC

  • Forbes columnist Avik Roy writes about good and bar Congressional efforts to control drug pricing.

From the American Society of Clinical Oncology (ASCO) conference currently being held in Chicago,

  • STAT News reports
    • “In patients with stage 3 lung cancer where a particular genetic mutation is present in the tumor, taking AstraZeneca’s cancer-fighting pill Tagrisso reduced the chance that disease would progress by 84%.
    • “This will be practice changing as soon as this becomes available,” said David R. Spigel, chief scientific officer of the Sarah Cannon Research Institute at a press conference announcing the results at the annual meeting of the American Society of Clinical Oncology. “This will be how patients are treated wherever they can get access to this drug.”
  • and
    • The cancer drug Enhertu stalled the growth of tumors by more than a year, significantly longer than standard chemotherapy did in women with the most common form of metastatic breast cancer — a clinical trial result that once again promises to rewrite the rules for the treatment of the disease.
    • The makers of Enhertu, Daiichi Sankyo and AstraZeneca, said the new data, if cleared by regulators, could shift the way physicians treat hormone receptor-positive, metastatic breast cancer, and create a new standard of care in which patients with breast tumors that express even the faintest amount of HER2 protein can benefit.
    • “It’s not an overestimation to say that trastuzumab deruxtecan is the most potent drug ever developed for breast cancer,” said Paolo Tarantino, a medical oncologist at the Dana-Farber Cancer Institute, using the scientific name for Enhertu. “It does come with side effects that we’re learning to manage, but with that said, I’ve never seen data like what’s being reported here.”
    • The results, from a Phase 3 study called Destiny-Breast06, were presented Sunday at the annual meeting of the American Society of Clinical Oncology.
  • and
    • Comfort can be delivered to patients with advanced cancer virtually just as well as in person, according to a new study presented on Sunday at the American Society of Clinical Oncology annual meeting in Chicago.
    • That’s welcome news to palliative care experts who have, in many cases, preferred the convenience and efficacy of telehealth sessions for both themselves and their patients since the Covid-19 pandemic forced virtual visits.

In other public health and medical research news,

  • The Wall Street Journal seconds STAT News by reporting
    • “There is more hope than ever for people diagnosed with the deadliest cancer. 
    • “Declines in smoking and the advent of screening and newer drugs have transformed the outlook for patients with lung cancer, once considered a death sentence. Progress against the disease has propelled the drop in overall cancer deaths in the U.S. over the past three decades.
    • “And there is more to gain. More patients can fend off the disease for months or years with targeted or immune-boosting drugs, [e.g., Tagrisso] results released this weekend at a top cancer conference showed. That includes patients with forms of the disease that are notoriously tough to treat.”
  • Fortune Well offers the “best science-backed strategies for a strong mind as you age.
  • The New York Time helps readers distinguish among spring allergies, the common cold, and Covid. This article reminded the FEHBlog that the Covid public health emergency ended a year ago last month.

From the U.S. healthcare business front,

  • “Fortune Well informs us a “longevity scientist’s three surprising predictions for the growing industry of healthy aging. The longevity scientist is “Alina Su, CEO of precision medicine and health tech company Generation Lab, at Fortune’s Brainstorm Health conference in Dana Point, Calif., last week. 
  • The Washington Post explains how “author and hospitality guru Chip Conley wants to replace the midlife crisis with a midlife renaissance.”
    • “In his book “Learning to Love Midlife: 12 Reasons Why Life Gets Better With Age,” Conley, 63, asks: “What if we could reframe our thinking about the natural transition of midlife not as a crisis, but as a chrysalis — a time when something profound awakens in us, as we shed our skin, spread our wings, and pollinate our wisdom to the world?”

 

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front,

  • Federal News Network tells us,
    • “The Biden administration, having struggled in some cases to set cybersecurity requirements for critical infrastructure, sees a new plan for minimum cyber standards coming together by early 2025.
    • “That’s according to Caitlin Durkovich, special assistant to the president and deputy homeland security advisor for resilience and response. During an event on Thursday hosted by the ICS Village, Durkovich spoke about the Biden administration’s efforts to implement a recently signed national security memorandum on critical infrastructure security.
    • “One of the reasons that we pushed so hard to make sure this NSM was signed out when it was, was so we had some runway to drive the implementation,” Durkovich said. “The president essentially signed it 270 days until the end of his first term. We wanted that first term to be able to implement the majority of actions.”
  • The Wall Street Journal reports,
    • “The U.S. Department of Health and Human Services doesn’t want to get caught flat-footed by the next healthcare hack. 
    • “The agency is leading work to create a map of the cybersecurity risks inherent in having a single technology supplier dominate a particular aspect of the market, a threat known as a single point of failure. The concern comes after a cyberattack on UnitedHealth Group’s Change Healthcare unit early this year produced cascading effects on health claims, freezing millions of dollars in payments. The repercussions took care providers, regulators and lawmakers by surprise.”
  • Yesterday, HHS added the following guidance to its Change Healthcare cyberattack FAQs:
    • “Covered entities affected by the Change Healthcare breach may delegate to Change Healthcare the tasks of providing the required HIPAA breach notifications on their behalf.
    • “Only one entity – which could be the covered entity itself or Change Healthcare – needs to complete breach notifications to affected individuals, HHS, and where applicable the media.
    • “If covered entities work with Change Healthcare to perform the required breach notifications in a manner consistent with the HITECH Act and HIPAA Breach Notification Rule, they would not have additional HIPAA breach notification obligations.
    • “The new and updated FAQs on the Change Healthcare Cybersecurity Incident may be viewed at: https://www.hhs.gov/hipaa/for-professionals/special-topics/change-healthcare-cybersecurity-incident-frequently-asked-questions/index.html.”

From the cyber vulnerabilities and breaches front,

  • The Cybersecurity and Infrastructure Security Agency (CISA) added the following known exploited vulnerabilities to its catalog this week:
  • Cybersecurity Dive adds,
    • The National Institute of Standards and Technology expects to clear the towering backlog of unanalyzed vulnerabilities in the National Vulnerability Database by the end of September, the agency said in a Wednesday update.
    • NIST scaled back its activities on the NVD program in mid-February following a change in interagency funding support and a staggering deluge of CVE disclosures. The agency reported an all-time high of 33,137 vulnerabilities last year, according to Flashpoint research.
    • To help clear the logjam, the agency awarded a cybersecurity analysis and email support contract to Maryland-based Analygence for $865,657 to support the processing of incoming vulnerabilities for the NVD, according to USAspending.gov. “We expect to begin performance the week of June 3,” Analygence COO Tom Peitler said via email.
  • HHS’s Health Sector Cybersecurity Coordination Center posted a “Healthcare Sector DDoS Guide.”
    • “A Distributed-Denial-of-Service (DDoS) attack is a type of cyber attack in which an attacker uses multiple systems, often referred to as a botnet, to send a high volume of traffic or requests to a targeted network or system, overwhelming it and making it unavailable to legitimate users. With the number of attacks increasing every year, they can come at any time, impact any part of a website’s operations or resources, and lead to massive amounts of service interruptions and huge financial losses. In the health and public health (HPH) sector, they have the potential to deny healthcare organizations and providers access to vital resources that can have detrimental impact on the ability to provide care.
    • “Disruptions due to a cyber attack may interrupt business continuity by keeping patients or healthcare personnel from accessing critical healthcare assets such as electronic health records, software based medical equipment, and websites to coordinate critical tasks. As such, this comprehensive DDoS guide is intended for target healthcare audiences to understand what DDoS attacks are; what causes them; types of DDoS attacks with timely, relevant examples; and mitigations and defenses against a potential attack.”

From the ransomware front,

  • Beckers Hospital Review lets us know,
    • “Most attacks on U.S. healthcare are coming from Russia, ABC affiliate KGTV reported May 28. 
    • “John Riggi, national advisor for cybersecurity and risk at the American Hospital Association, told the publication that ransomware attacks targeting hospitals have increased by more than 300%, with most of these attacks coming from Russia.
    • “The Russian government refuses to cooperate with U.S. law enforcement on these issues, therefore providing them safe harbor,” he told the news outlet.
    • “Mr. Riggi noted that ransomware gangs have also been identified operating in China, North Korea and Iran.
    • “The hacking groups most actively targeting healthcare as of April 2024 were LockBit, BlackCat/ALPHV and BianLian, according to HHS’ Health Sector Cybersecurity Coordination Center, or HC3.”
  • CSO adds,
    • “Two weeks ago, the UK National Crime Agency and the US Department of Justice announced unmasked the Russian national alleged to be the creator and administrator of the LockBit ransomware program.
    • “Now, cybersecurity company NCC Group reports that for the first time in eight months, LockBit has also been overtaken by Play as the world’s top ransomware gang, with 32 attacks in April compared to LockBit’s 23 attacks.”
  • Bloomberg informs us,
    • “It’s time to formally stop ransom payments.
    • “That’s the argument that a top cybercrime researcher — one who until recently staunchly opposed such a ban — made to scores of threat intelligence experts who gathered last week in a darkened basement ballroom at a hotel not far from the US Capitol.
    • “Banning ransom payments is an extreme step but it also might be the least bad option available to us,” Allan Liska, a threat analyst at the cyber firm Recorded Future, told the crowd. * * *
    • “On stage, Liska said he’s aware of the counter arguments: A ban won’t work to stop attacks, and blocking companies paying ransoms will do them harm. But, he said, what companies are doing now hasn’t stopped attacks either. While blocking payments might hurt some companies, so do the breaches themselves, he said. 
    • “Afterwards, Liska told me he was “dragged kicking and screaming” into opposing ransom payments. The unrelenting pace of attacks last year convinced him that it was time to take a radical step. 
    • “It’s not because I think it’s a good idea. It’s because, right now, nothing else has worked and we need to do something,” he said. “I don’t know what else it could possibly be.”

From the cyber defenses front,

  • Cyberscoop relates,
    • “A coalition of international law enforcement agencies carried out what they said was the “largest ever” operation to counter botnet and dropper malware by taking down or disrupting more than 100 servers, seizing 2,000 domains and identifying nearly 70 million euros earned by one of the main suspects in the case. 
    • “Officials with Europol announced early Thursday that “Operation Endgame” targeted droppers — malware used to get other malware onto a system — used extensively to facilitate a range of consequential cybercrimes, including IcedID, SystemBC, Pikabot, Smokeloader, Bumblebee and Trickbot.
    • “As part of the operation, authorities made one arrest in Armenia and three in Ukraine, and eight suspects linked to the activities and wanted by Germany will be added to Europe’s Most Wanted list, Europol said in its statement.”
  • Modern Healthcare reports,
    • “Healthcare’s cybersecurity challenges have shined a light on how the industry has failed to protect patient data by not dedicating enough resources to address the problem.  
    • “Health systems and insurers are dealing with the aftermath of the industry’s latest large-scale ransomware attacks on St. Louis-based Ascension, UnitedHealth Group’s Change Healthcare and Chicago-based Lurie Children’s Hospital, among others. Conversations are happening over whether organizations should be bringing in outside consultants or hiring more employees, executives say.
    • “Do we have enough people? Do we need consulting help to accelerate resiliency projects and testing? Those are the conversations going on right now,” said James Case, chief information security officer at Jacksonville, Florida-based Baptist Health. “The current climate is causing us to bubble those conversations to the top, and whether we should get help one way or another.”  
  • Here’s a link to Dark Reading’s CISO Corner.

Friday Factoids

David Ermer–AHRQ, CDC, COVID-19, FDA, Medicare, Mental health care, NCQA, No Surprises Act, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Bloomberg News reports,
    • “Federal agencies are aiming to issue final regulations this year that aim to make the arbitration process more efficient for No Surprises Act health care payment disputes, an IRS official said.
    • “The regulations are a priority for the Treasury, Labor, and Health and Human Services departments, said IRS Office of Chief Counsel Senior Technician Reviewer Kevin Knopf during a Thursday panel at the Federal Bar Association’s Insurance Tax Seminar.
    • “The proposed rules aim to reduce certain administrative fees tied to participating in an independent dispute resolution system that arbitrates clashes between medical providers and health insurers over payments. They also aim to clarify requirements to prove that a dispute is eligible for the dispute resolution process.” 
  • The Department of Health and Human Services (“HHS”) announced,
    • “Today, on National Heat Awareness Day, the U.S. Department of Health and Human Services (HHS) is launching a new tool to help communities prepare for extreme heat and prevent heat-related illness, especially among those most at risk. The Heat and Health Index (HHI) is the first nationwide tool to provide heat-health outcome information at the ZIP code level. The HHI will help state and local officials identify communities, at the zip code level, most likely to experience negative health outcomes from heat, ensure that outreach and medical aid reach the people who need it most, and help decision-makers prioritize community resilience investments.”
  • The National Committee for Quality Assurance released a fact sheet about Mental Health Awareness Month, which ended today.
  • HHS’s Agency for Health Research and Quality tells us,
    • “As we round out Older Americans Month, it is crucial that we continue to recognize the significant contributions of older adults and the urgent need to transform and improve their healthcare. Our current system is ill-equipped to meet the complex needs of older adults, who often contend with multiple chronic conditions. This inadequacy leads to fragmented and sub-optimal care, resulting in poor health outcomes, avoidable adverse events, hospitalizations, institutionalization, and increased costs. 
    • “To meet these challenges, AHRQ remains committed to using its research capabilities to build the evidence base and identify solutions ready for action. To do so, the agency has released a Special Emphasis Notice to announce its strong interest in funding health services research to improve care quality for older adults.  Research proposals for enhancing service access, delivery, organization, and equitable distribution are welcome. In particular, AHRQ seeks research to address critical questions related to the development, implementation, evaluation, and scalability of person-centered models of care to optimize older adults’ physical and mental health, functional status, and overall well-being.” 
  • BioPharma Dive informs us,
    • The Food and Drug Administration on Friday approved a third vaccine for respiratory syncytial virus, clearing a shot from biotechnology company Moderna one year after granting a green light to vaccines from GSK and Pfizer.
    • The vaccine, dubbed mResvia, is for the prevention of disease caused by respiratory syncytial virus, or RSV, in adults 60 years of age and older. Experts from the Centers for Disease Control and Prevention are expected to meet next month to provide recommendations on the shot’s use. Moderna had said it expects the vaccine to be available in time for the fall immunization season in the U.S.
  • The Centers for Disease Control (CDC) adds,
    • “The RSV vaccine is not currently an annual vaccine, meaning people do not need to get a dose every RSV season. Currently, CDC recommends only a single dose of RSV vaccine for adults ages 60 and older, using shared clinical decision-making. Additional surveillance and evaluation activities are ongoing to determine whether older adults might benefit from receiving additional RSV vaccines in the future. So far, RSV vaccines appear to provide some protection for at least two RSV seasons.”

From the public health and medical research front,

  • HHS posted a “Fact Sheet: In Response to H5N1, HHS and USDA Focus on Protecting Farmworkers.” For more information on the ongoing response, please visit FDA, CDC, and USDA’s ongoing H5N1 update pages.
  • STAT News reports,
    • “There are a lot of reasons why updated data on Pfizer’s Lorbrena, a treatment for non-small cell lung cancer, might not seem to be a big deal. The results are an update on the clinical trial that resulted in the Food and Drug Administration granting Lorbrena full approval in 2021, so in a sense they are not even that new. For Pfizer investors, Lorbrena isn’t that big a deal, either. The medicine, for patients whose lung tumors have particular genetic mutations, generated only $575 million last year — an amount that is up 57% from the year prior, but that still constitutes only 1% of the drug giant’s annual sales.
    • “But there is one number that makes the Lorbrena data quite eye-catching: In the updated data, the daily pill decreased the risk that cancer would progress or that a patient would die by 81% over five years.
    • “That’s a stunning number, especially when one considers that Lorbrena was not being compared to an inert placebo but to Xalkori, another Pfizer targeted cancer drug.
    • “Put a different way, 60% of the patients who received Lorbrena were alive and had not seen their tumors progress in the five years of the study, compared to 8% who received Xalkori.
    • “The data are being presented at the annual meeting of the American Society of Clinical Oncology and published in the Journal of Clinical Oncology.“
  • BioPharma Dive informs us,
    • “People with chronic myeloid leukemia, a simmering cancer of the bone marrow, are often treated with one of several targeted drugs that, over the past two decades, have helped to substantially prolong survival from the disease.
    • “Study results revealed Friday suggest that Scemblix, the newest of those therapies, can be both safer and more effective, potentially supporting wider use of it as an initial treatment. The results are from a late-stage clinical trial run by Scemblix’s maker, Novartis, and will be presented at the American Society of Clinical Oncology’s annual meeting.
    • “In the trial, dubbed ASC4FIRST, Scemblix led to treatment responses in significantly more participants than did other targeted drugs, which included the mainstay therapy Gleevec as well as more recently introduced medicines. Additionally, more people given Novartis’ drug experienced what’s called a “deep molecular response,” which over time can be considered a remission and allow treatment to be stopped.
    • “Study researchers also reported “markedly favorable safety and tolerability” for Scemblix, compared to Gleevec and the other so-called kinase inhibitors it was tested against.”
  • Medscape notes,
    • A personalized diet, created by integrating microbiome analysis with artificial intelligence (AI) algorithms, is a promising approach to the management of irritable bowel syndrome(IBS) symptoms, leading to enhanced symptom relief and greater gut microbiome diversity than a standard low–fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet, new research suggests.
  • and
    • “About 9 out of 10 people will have a genetic difference in their DNA that can impact how they respond to common medications,” said Emily J. Cicali, PharmD, a clinical associate at the University of Florida College of Pharmacy, Gainesville, Florida.
    • “Cicali is the clinical director of UF Health’s MyRx, a virtual program that gives Florida and New Jersey residents access to pharmacogenetic (PGx) tests plus expert interpretation by the health system’s pharmacists. Genetic factors are thought to contribute to about 25% or more of inappropriate drug responses or adverse events, said Kristin Wiisanen, PharmD, dean of the College of Pharmacy at Rosalind Franklin University of Medicine and Science in North Chicago, Illinois.
    • “Pharmacogenetics helps consumers avoid drugs that may not work well for them or could cause serious adverse events. It’s personalized medicine,” Cicali said.
    • “Through a cheek swab or blood sample, the MyRx program — and a growing number of health system programs, doctors’ offices, and home tests available across the United States — gives consumers a window on inherited gene variants that can affect how their body activates, metabolizes, and clears away medications from a long list of widely used drugs.”
  • The Wall Street Journal recounts the experiences of readers months after stopping GLP-1 drug treatment.

From the U.S. healthcare business front,

  • The Employee Benefit Research Institute relates.
    • According to findings of the Employee Benefit Research Institute (EBRI)/Greenwald Research Consumer Engagement in Health Care Survey, most plan enrollees are satisfied with their health plan, but high-deductible health plan (HDHP) enrollees are less likely to be extremely or very satisfied than traditional plan enrollees.
    • HDHP and traditional plan enrollees are both satisfied with the quality of care received and choice of doctors.
    • Differences in overall satisfaction may be driven by cost sharing. HDHP enrollees are less likely than traditional plan enrollees to be extremely/very satisfied with out-of-pocket expenses for prescription drugs and other health care services.
  • Beckers Hospital Review reports,
    • “The Justice Department has rejected bankrupt Dallas-based Steward Health Care’s suggested auction timeline for its physician group Stewardship Health to be sold to UnitedHealth Group’s subsidiary Optum. 
    • “In a May 28 bankruptcy court filing, obtained by Becker’s, Brian Boynton, principal deputy attorney general for the justice department, detailed how the debtor-in-possession financial deal between Steward and its landlord Medical Properties Trust interferes with the health system’s “obligation to comply with the United States’ antitrust review” of the Stewardship Health, Optum deal and should not be approved.”
  • and calls attention to an American Hospital Association report identifying the inpatient and outpatient services that are biggest money losers for hospitals.
  • Healthcare Dive points out,
    • “Most of the nation’s leading nonprofit healthcare providers reported progress toward financial recovery during earnings for the quarter ended March 31.
    • “However, improvements varied widely by health system, and the industry at large has a long way to go before it is back to profitability levels enjoyed pre-pandemic — if it fully rebounds at all, analysts told Healthcare Dive.
    • “Nonprofits struggled with cost challenges, confirming reports from analysts at credit rating agencies Moody’s Ratings and Fitch Ratings that predicted expenses, particularly labor costs, would continue to vex providers in 2024.
    • “Analysts also expected this year to bring a bifurcated financial recovery for the sector, where health systems that could successfully contain costs would recover more quickly.
    • “With early financial data now in for 2024, that expectation appears to be playing out.”

Thursday Miscellany

David Ermer–CDC, CMS, Medical / Rx research, Mental health care, NIH, Telehealth, U.S. Healthcare, Wellness–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Department of Health and Human Services announced,
    • Today the U.S. Department of Health and Human Services, through its Administration for Community Living, released “Aging in the United States: A Strategic Framework for a National Plan on Aging – PDF.” The report lays the groundwork for a coordinated effort – across the private and public sectors and in partnership with older adults, family caregivers, the aging services network, and other stakeholders – to create a national set of recommendations for advancing healthy aging and age-friendly communities that value and truly include older adults. The national plan on aging will advance best practices for service delivery, support development and strengthening of partnerships within and across sectors, identify solutions for removing barriers to health and independence for older adults, and more. Developed by leaders and experts from 16 federal agencies and departments working together through the Interagency Coordinating Committee (ICC) on Healthy Aging and Age-Friendly Communities, the report also reflects input from community partners and leaders in the aging services network.
  • The Assistant Secretary of Labor for Employee Benefit Security, Lisa Gomez, reminds us,
    • “May is Mental Health Awareness Month, reminding us of the critical need to prioritize mental well-being – especially in the workplace where many spend a significant portion of their time. Did you know that more than 1 in 5 adults in America live with a mental illness? Mental health issues can affect job performance, relationships and overall well-being. Understanding your rights and support systems can make a world of difference. 
    • “Here are three actions you can take to get the mental health care you deserve through your job-based health plan: 
    • “Use your benefits: * * * For more information, read our publication “Understanding Your Mental Health and Substance Use Disorder Benefits.”
    • “Don’t take no for an answer: * * * You also can look at our publication “Filing a Claim for Your Benefits” for steps to help navigate this process. 
    • “Contact the Department for help:  Know that support for your mental health journey is available – you don’t have to go through it alone. One source of support is found by contacting a benefits advisor with the Department’s Employee Benefits Security Administration at askebsa.dol.gov or by calling 1-866-444-3272 for assistance with any questions or problems you encounter when trying to use the mental health and substance use disorder benefits under your job-based health plan. The benefits advisors can help you understand your rights, your health plan and its appeal process.”
  • The American Hospital News lets us know,
    • “The Centers for Disease Control and Prevention May 29 published a blog co-authored by AHA, the National Institute for Occupational Safety and Health and the Agency for Healthcare Research and Quality, highlighting efforts by federal agencies and the hospital field to address the mental health and well-being of health care workers following incidents of workplace violence. The blog contains several resources, such as AHA’s Hospitals Against Violence Initiative, the Building a Safer Workplace and Community infographic, and information about #HAVhope Friday on June 7 * * *.
  • HR Dive informs us,
    • “Employers run afoul of federal law when they fire someone for not disclosing a disability during a job interview or for waiting until after they were hired to ask for an accommodation, the U.S. Equal Employment Opportunity Commission warned in a May 21 lawsuit.
    • “Per the complaint in EEOC v. All Day Medical Care Clinic, LLC, on her first day of work, a scheduling assistant for a Maryland-based healthcare provider notified the CEO she had a vision impairment and needed a magnifier and Zoomtext software as an accommodation. The CEO allegedly advised her that things would have been different if she’d mentioned her disability and accommodation needs during her interview and told her to leave, according to court documents.
    • “The EEOC sued the healthcare provider for allegedly violating the Americans with Disabilities Act. Under the ADA, “job applicants do not need to reveal their disabilities before being hired,” Debra Lawrence, regional attorney for the EEOC’s Philadelphia district office, explained in a press release. “When an employer penalizes an employee for not raising issues of disability and reasonable accommodation, it is requiring the employee to reveal information the employee legally does not have to divulge,” Lawrence said. All Day Medical Care did not respond to a request for a comment prior to press time.”

From the public health and medical research front,

  • The New York Times reports,
    • “A third farmworker in the United States has been found to be infected with bird flu, heightening concerns about an outbreak among dairy cattle first identified in March.”A third farmworker in the United States has been found to be infected with bird flu, heightening concerns about an outbreak among dairy cattle first identified in March.
    • “The worker is the first in this outbreak to have respiratory symptoms, including a cough, sore throat and watery eyes, which generally increase the likelihood of transmission to other people, federal officials said on Thursday.
    • “The other two people had only severe eye infections, possibly because of exposure to contaminated milk.
    • “All three individuals had direct exposure to dairy cows, and so far none has spread the virus to other people, Dr. Nirav Shah, principal deputy director of the Centers for Disease Control and Prevention, said at a news briefing.”
  • The National Institutes of Health announced,
    • “Using a combination of cutting-edge immunologic technologies, researchers have successfully stimulated animals’ immune systems to induce rare precursor B cells of a class of HIV broadly neutralizing antibodies (bNAbs). The findings, published today in Nature Immunology, are an encouraging, incremental step in developing a preventive HIV vaccine.”
  • The Institute for Clinical and Economic Review released,
    • “its revised Evidence Report assessing the comparative clinical effectiveness and value of ensifentrine (Verona Pharma) for the treatment of chronic obstructive pulmonary disease (COPD).”its revised Evidence Report assessing the comparative clinical effectiveness and value of ensifentrine (Verona Pharma) for the treatment of chronic obstructive pulmonary disease (COPD).
    • “COPD is a common cause of severe respiratory problems,” said ICER’s Chief Medical Officer, David Rind, MD. “People with COPD can experience persistent shortness of breath and fatigue that can significantly affect their daily activities. Current evidence shows that ensifentrine decreases exacerbations when used in combination with some current inhaled therapies and is well-tolerated by patients, but there are uncertainties about how much benefit it may add to unstudied combinations of inhaled treatments.” * * *
    • “Key Clinical Findings“Key Clinical Findings
      • “ICER does not have significant concerns about harms with ensifentrine. We have high certainty that ensifentrine added to maintenance therapy, compared with maintenance therapy alone, results in at least a small net health benefit, and may result in substantial net health benefit (“B+”). We have somewhat greater certainty in the benefits when ensifentrine is added to the regimens studied in the clinical trials than when added to optimized modern inhaler therapies for COPD.
    • “Key Cost-Effectiveness Findings
      • “Ensifentrine has not yet been approved by the FDA, and the manufacturer has not announced a US price if approved. ICER has calculated a health-benefit price benchmark (HBPB) for ensifentrine to be between $7,500 to $12,700 per year.”
  • The Centers for Medicare Services is contemplating moving coverage of PreExposure Prophylaxsis using Antiviral Therapy to prevent HIV infection from Medicare Part D to Medicare Part B.
  • The Wall Street Journal relates,
    • “Screens are inherently harmful to our sleep, right?
    • “It isn’t that black and white, some sleep experts now say.
    • “Spurred by recent research, sleep scientists and doctors are rethinking the conventional wisdom. In some cases, they are backing away from dogmatic approaches such as cutting out screens two hours before bedtime. And they are questioning how much the dreaded “blue light” actually delays sleep.
    • “It is becoming more evident that the tech in and of itself isn’t always the problem,” says Shelby Harris, a clinical psychologist specializing in behavioral sleep medicine in New York. “We need to figure out how to tailor the recommendations to the person.”
  • Mercer Consulting discusses “Help for opioid addiction: Some progress, much more to do.” 

From the U.S. healthcare business front,

  • Beckers Payer Issues shares the views of 32 payer executives about changes to healthcare delivery in the next ten years. For example,
    • Bruce Rogen, MD. Chief Medical Officer of Cleveland Clinic Employee Health Plan: Longitudinal patient records on each patient accessible by providers caring for the patient having a complete history of clinical data sourced from multiple EMRs and across payers and over time going back years if not decades.
    • AI platforms that are able to access the longitudinal patient record to engage the patient in preventive care, filling gaps in care, managing medication refills, enhancing medication compliance, and obtaining prior authorization from payers when indicated.
    • Teams of healthcare providers using the longitudinal patient record and the AI platforms to provide care anywhere and everywhere (hospital, post-acute, home care, remote, virtual) and focusing on prevention. The team includes physicians, nurses, navigators, care coordinators, pharmacists, social workers, behavioral health psychologists and counselors, community healthcare workers and home care workers.
    • Ilan Shapiro, MD. Chief Health Correspondent, Medical Affairs Officer and Senior Vice President at AltaMed (Los Angeles): In 10 years, healthcare delivery will likely be more patient-centric and value-based, with AI technology playing a crucial role in both treatment and prevention of illnesses. Patients will be incentivized for proactive wellness steps, fostering a culture of health promotion. Nationwide care coordination will be streamlined, reducing constraints and enhancing accessibility. This transformation will empower patients and healthcare teams, ensuring that care is brought back to the community level.
  • Per FierceHealthcare
    • “Well-being programs continue to be a central focus for employers, and they’re evolving the reach of these offerings into new areas such as the social determinants of health, according to a new survey.
    • “The Business Group on Health and Fidelity Investments released their annual look at employers’ strategies around wellness on Wednesday, and found nearly all of the 160 surveyed firms said they view well-being programs as a being key to their overall strategy. These employers said they intend to continue funding these programs at current levels.
    • “In addition, more than half (51%) said they plan to build out their well-being programs to tackle social needs in the next three to five years.”
  • The Wall Street Journal examines the connection between private equity investments and growing healthcare costs.
    • “Consolidation is as American as apple pie.
    • “When a business gets bigger, it forces mom-and-pop players out of the market, but it can boost profits and bring down costs, too. Think about the pros and cons of Walmart and “Every Day Low Prices.” In a complex, multitrillion-dollar system like America’s healthcare market, though, that principle has turned into a harmful arms race that has helped drive prices increasingly higher without improving care. 
    • “Years of dealmaking has led to sprawling hospital systems, vertically integrated health insurance companies, and highly concentrated private equity-owned practices resulting in diminished competition and even the closure of vital health facilities. As this three-part Heard on the Street series will show, the rich rewards and lax oversight ultimately create pain for both patients and the doctors who treat them. Belatedly, state and federal regulators and lawmakers are zeroing in on consolidation, creating uncertainty for the investors who have long profited from the healthcare merger boom.”
  • STAT News considers the lack of consensus over the meaning of value-based care. Sigh.
    • “Mai Pham, president of the Institute for Exceptional Care, said her benchmark for success is not how health care providers are feeling. It’s what is actually happening to the nation’s health, and the status quo in her view is unacceptable. Life expectancy among Americans has plateaued, and life expectancy for Americans in the prime years of their lives is falling. This trend, Pham noted, started before the Covid-19 pandemic, and it’s happening across races and geography.
    • “It’s difficult to say whether value-based care has been a success. Medicare has tried a broad range of programs and strategies, each of which has involved a broad range of organizations. Some have done well, others have not.
    • “So it’s not a binary answer,” Pham said. “What I would say is that it has not lived up to the hype.”
  • mHealth Intelligence tells us,
    • “Though telehealth use skyrocketed among United States adults with private health insurance during the COVID-19 pandemic, new research reveals that rural residents utilized telehealth less than their urban peers.
    • “The research, published by the AARP Public Policy Institute last week, examined changes in telehealth use from 2019 to 2021 among people younger than 65 enrolled in private, employer-sponsored health insurance plans.”

Midweek Update

David Ermer–CDC, Congress, COVID-19 vaccine, Generative AI, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • The New York Times reports,
    • “The chairmen of two Senate committees overseeing health policy, concerned about companies “padding their own profits” at the expense of patients, are looking into the practices of a data analytics firm that works with big insurers to cut payments to medical providers.
    • “The firm, MultiPlan, recommends what it says are fair payments for medical care, but the firm and the insurers can collect higher fees when payouts are lower. This business model could “result in an improper conflict of interest,” the chairmen of the two committees, Ron Wyden of Oregon and Bernie Sanders of Vermont, wrote in a letter to the firm’s chief executive that was released on Tuesday.
    • “The senators called on MultiPlan to meet with the committees’ staffs to discuss an investigation last month by The New York Times that found the firm’s pricing tools could leave patients with unexpectedly large bills when they see doctors outside their health plans’ networks.”
  • Govexec tells us,
    • “The Office of Personnel Management last week gave agencies a reminder that as campaign season approaches, officials should be vigilant against efforts to “burrow” political appointees into career positions in the federal government’s competitive and Senior Executive services.
    • “In a memo to agency heads, OPM’s associate director for merit system accountability and compliance Mark Lambert and associate director for workforce policy and innovation Veronica Hinton addressed the controversial practice, which is legal, albeit with a strict set of regulations to ensure political appointees are qualified for career roles they’re lined up for.”
  • KFF introduced,
    • “A new KFF resource—Health Policy 101—explains the basics on a wide range of topics about health programs and policy in the United States, such as Medicare and Medicaid, the Affordable Care Act, health care costs and affordability, women’s health issues, and the politics of health care. Health Policy 101 chapters are available online and can be downloaded in PDF format. The “101” was created to serve as a mini “textbook” for faculty and students interested in health policy. Dr. Drew Altman, KFF’s president and CEO, is the editor of the 101 series.”

From the public health and medical research front,

  • MedPage Today informs us,
    • “The updated monovalent XBB.1.5 COVID-19 vaccines were effective against Omicron subvariants circulating during the most recent respiratory virus season, but their effectiveness waned over time, according to a brief report.
    • “The three vaccines updated to target the SARS-CoV-2 XBB.1.5 subvariant — Moderna’s and Pfizer-BioNTech’s mRNA vaccines and the Novavax vaccine — were 66.8% effective against hospitalization at 4 weeks, decreasing to 57.1% after 10 weeks, wrote Dan-Yu Lin, PhD, of the UNC Gillings School of Global Public Health in Chapel Hill, North Carolina, and colleagues.
    • “Vaccine effectiveness against infection was about 52% after 4 weeks, decreasing to 33% after 10 weeks, and to 20% after 20 weeks, the New England Journal of Medicineopens in a new tab or window correspondence showed.
    • “We expected these vaccines to be effective, especially against hospitalization and death. We also expected the effectiveness to decline over time,” Lin told MedPage Today. “However, we didn’t know beforehand the levels of effectiveness or the duration of protection.”
  • The Wall Street Journal shares the view of readers who have used GLP-1 drugs.
    • “Hundreds of readers responded in the comments space and by email to Bradley Olson’s essay about his experience using a GLP-1 drug for weight loss. Readers shared stories about their own attempts to lose weight, journeys that often took place over the course of decades and included nonmedicinal strategies before the advent of GLP-1 drugs. Our readers made overwhelmingly positive comments about the medications, and in general found that the transformational impact of the GLP-1 drugs made such difficulties as getting prescriptions filled and side effects bearable. Some readers who have struggled to lose weight wrote that they found inspiration in Olson’s essay to consider trying a medical solution.” 
  • Per BioPharma Dive,
    • “A new kind of antidepressant eased symptoms and improved sleep among adults enrolled in a large Phase 3 trial, Johnson & Johnson, the drug’s developer, said Wednesday.
    • “J&J is studying the drug, called seltorexant, as an “adjunctive” therapy to background treatment with other antidepressants like SSRIs. The company’s trial enrolled adults with major depressive disorder as well as insomnia, which often accompanies depression and isn’t well treated by SSRIs.
    • “J&J didn’t disclose detailed data in its Wednesday statement. But the company did share the trial met all of its primary and secondary goals, noting the improvement in depressive symptoms among seltorexant-treated participants at study day 43 was both statistically significant and clinically meaningful.”
  • The New York Times dives into recent research on the sense of taste.
    • “The perception of taste is a remarkably complex process, starting from that first encounter with the tongue. Taste cells have a variety of sensors that signal the brain when they encounter nutrients or toxins. For some tastes, tiny pores in cell membranes let taste chemicals in.
    • “Such taste receptors aren’t limited to the tongue; they are also found in the gastrointestinal tract, liver, pancreas, fat cells, brain, muscle cells, thyroid and lungs. We don’t generally think of these organs as tasting anything, but they use the receptors to pick up the presence of various molecules and metabolize them, said Diego Bohórquez, a self-described gut-brain neuroscientist at Duke University. For example, when the gut notices sugar in food, it tells the brain to alert other organs to get ready for digestion.”
  • Healio lets us know,
    • “Women who get an epidural during delivery appear to have a marked reduction in serious complications the first few weeks after giving birth, a new study shows.
    • “A painkilling epidural can reduce risk by 35% in women for complications like heart attack, heart failure, blood infection and hysterectomy that can occur as a result of delivery, researchers reported May 22 in the BMJ.
    • “And the risk declines even more for women with known risk factors for these complications such as obesity, other health problems or prior delivery, researchers said.
    • “For those women, an epidural can reduce their risk of complications by 50%, compared to a 33% risk reduction in those without such factors.
    • “And women delivering preterm had a risk reduction of 47%, results show.”
  • and
    • “Researchers found that a questionnaire successfully identified patients with STIs who can be safely evaluated for penicillin allergy by skin test or by a two-step graded oral challenge, according to a study.
    • “Providers caring for clients with STIs are often faced with clients reporting a history of penicillin allergy (up to 15% of clients). Penicillin remains the drug of choice for the treatment of all stages of syphilis,” Rebecca A. Lillis, MD, associate professor at the Louisiana State University School of Medicine, told Healio.
    • “Ceftriaxone is the drug of choice for treatment of gonorrhea and often avoided in clients who report a penicillin allergy, resulting in suboptimal care,” she said.”
  • The National Institutes of Health announced,
    • “A team of researchers funded by the National Institutes of Health have generated the first complete chromosome sequences from non-human primates. Published in Nature(link is external), these sequences uncover remarkable variation between the Y chromosomes of different species, showing rapid evolution, in addition to revealing previously unstudied regions of great ape genomes. Since these primate species are the closest living relatives to humans, the new sequences can provide insights into human evolution.”

From the U.S. Healthcare business front,

  • Per Fierce Healthcare,
    • “A significant gap exists between health plans that have the highest consumer experience scores and those with the lowest, according to a new survey from J.D. Power.
    • “The consumer insights firm released its annual look at commercial health plans and found that overall satisfaction lands at a score of 595 out of 1,000 points, an increase of three points from 2023’s survey. However, the analysts found a 79-point gap between plans with the highest and lowest scores.
    • “Further, plans with the best consumer satisfaction ratings are getting better, while the lowest-performing plans are sliding. Scores at the highest performers increased by 20 points, while lower scores declined by eight points.
    • “In many cases, employer-sponsored health insurance is consumers’ primary window into the healthcare system,” said Christopher Lis, Ph.D., managing director of global healthcare intelligence at J.D. Power, in a press release. “Access to care, cost of care, chronic condition management—the central pillars of the consumer healthcare experience—are all heavily influenced by commercial health plans.”
  • and
    • “The proportion of hospitals meeting the Office of the National Coordinator for Health IT’s (ONC’s) bar for interoperability rose substantially from 2018 to 2023, though a focus on day-to-date data exchange will be necessary to fill some remaining gaps.
    • “According to a recent data brief from ONC, 7 in 10 nonfederal acute care hospitals reported either “routinely” or “sometimes” engaging in all four measured domains of electronic health information interoperability: sending data (92%), receiving data (87%), querying data from outside their organization (84%) and integrating outside data into their records without manual entry (78%).
    • “The 70% top line is an improvement from the 23% of 2014 and the 46% of 2018. Interoperability remained flat at 70% from 2022 to 2023, though the ONC noted that its surveys for the two years were fielded nearly back-to-back to catch up following pandemic polling delays.”
  • Beckers Payer Issues points out,
    • “UnitedHealth Group is running around 500 use-case applications for AI across the organization, CEO Andrew Witty told investors. 
    • “Speaking at a conference on May 29, Mr. Witty said some of the company’s AI efforts are “low-hanging” opportunities aimed at speeding up administrative processes. 
    • “It’s not Einstein opportunities,” he said. “These are relatively straightforward. Some of them are already underway. They play out in areas like speed, allowing call handlers to deal with issues faster than they used to.” 
    • “Heather Cianfrocco, CEO of Optum, told investors Optum’s AI efforts are focused in two areas. 
    • “One is administrative support, particularly for clinicians, giving clinicians time back at home or in the office,” Ms. Cianfrocco said. “The second area I would highlight is identifying disease progression, or emerging disease, faster.” 

 

Tuesday Tidbits

David Ermer–Congress, Federal employment benefits, Medical / Rx research, NIH, Obesity, OPM, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • FedWeek informs us that
    • “Congress has started to craft the appropriations bills and the annual DoD authorization bill, the key measures for decisions on the upcoming year’s federal employee raise and on workplace policy changes.
    • “While it’s generally expected that none of those measures will be enacted into law before the elections — when Congress returns next week from its current recess, it will have only nine scheduled working weeks before November — the measures for the meantime will serve to stake out positions. * * *
    • “The primary bill affecting federal workplace policies, the financial services-general government measure, is set for voting next week at the subcommittee level and the following week for at the committee level.”
  • Federal News Network tells us,
    • “The Office of Personnel Management is working to address a spike in fraudulent activity on hundreds of accounts in a flexible spending account (FSA) program for federal employees.
    • “Several hundred federal employees currently enrolled in FSAFEDS have experienced recent fraudulent activity on their accounts. Scammers have used the employees’ personal information to either create new, fraudulent FSAs, or otherwise make fraudulent reimbursement claims on existing FSAs. * * *
    • “The fraudulent activity in FSAFEDS is relatively limited in scope, since it’s affecting just a few hundred federal employees’ accounts. In total, the scammers have managed to shore up a couple hundred thousand dollars, Politico first reported last week.
    • “Since becoming aware of the fraud, HealthEquity has already taken additional security measures by implementing Login.gov requirements and setting up dual-factor authentication for federal employees to be able to log in to their FSAFEDS accounts. * * *
    • “Agency benefits officers and payroll providers are advising federal employees who use FSAFEDS to review and verify their leave, earnings, and FSA account statements. If employees notice any suspicious charges or activity, they can call FSAFEDS at 877-372-3337.”
  • The Congressional Research Service posted a Legal Sidebar titled “HHS Finalizes Rule Addressing Section 1557 of the ACA’s Incorporation of Title IX” of the Education Amendments of 1972.
  • Newfront reminds us,
    • “IRS Notice 2023-70 adjusts the Patient-Centered Outcomes Research Institute (PCORI) fee to $3.22 per covered individual for health plan years ending on or after October 1, 2023 and before October 1, 2024, which includes 2023 calendar plan years. This represents a $0.22 per covered individual increase from last year’s PCORI fee (from $3.00).
    • “The annual PCORI fee must be reported and paid to the IRS by July 31, 2024, via the second quarter Form 720.”
  • The American Hospital Association News reports,
    • “A coalition of 230 national associations, including the AHA, submitted a letter the week of May 20 to the Federal Trade Commission requesting a stay on the Sept. 4 effective date of the Non-Compete Clause Final Rule to allow for judicial review.
    • “Under Section 705 of the Administrative Procedure Act, agencies ‘may postpone the effective date of action taken by it, pending judicial review’ when ‘justice so requires,'” the letter notes. “We strongly encourage you to exercise this power on the Noncompete Rule as FTC and other agencies recently have on other rulemakings.”
    • “The organizations said a lack of FTC guidance on key pieces of the rule, such as what it means to be in a policymaking position or how the FTC will apply its functional test, has created substantial uncertainty for businesses and employees nationwide. The final rule is currently being challenged in court by several parties, including the U.S. Chamber of Commerce. A decision is expected this summer.”
  • Mercer Consulting discusses how Part D enhancements for 2025 may impact Part D creditable coverage reporting, an OPM requirement for FEHB carriers.
    • “One of the outstanding questions that was addressed by CMS guidance is what the standard Part D coverage actuarial value will be for testing creditable coverage. Helpfully, CMS guidance provided that “discounts paid by manufactures are not included in the [Part D] plan paid amount when making a determination about creditable coverage.”
    • “This helpful clarification confirmed Mercer’s original interpretation that while it may be somewhat harder for some group health plans to pass creditable coverage testing, the passing threshold is not as drastic of an increase as many initial outside reports originally suggested.
    • “In addition, CMS clarified that it will continue to permit use of its 2009 creditable coverage simplified determination methodology, without modification to the existing parameters, for 2025 for group health plan sponsors not applying for the retiree drug subsidy. CMS will re-evaluate the continued use of the existing simplified determination methodology, or establish a revised one, for 2026 in future guidance.”

From the public health and medical research front,

  • The National Institutes of Health lets us know,
    • “Feeding children peanut products regularly from infancy to age 5 years reduced the rate of peanut allergy in adolescence by 71%, even when the children ate or avoided peanut products as desired for many years. These new findings, from a study sponsored and co-funded by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID), provide conclusive evidence that achieving long-term prevention of peanut allergy is possible through early allergen consumption. The results were published today in the journal NEJM Evidence.
    • “Today’s findings should reinforce parents’ and caregivers’ confidence that feeding their young children peanut products beginning in infancy according to established guidelines can provide lasting protection from peanut allergy,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H. “If widely implemented, this safe, simple strategy could prevent tens of thousands of cases of peanut allergy among the 3.6 million children born in the United States each year.”
    • “The new research findings come from the LEAP-Trio study, which builds on the seminal results of the Learning Early About Peanut Allergy (LEAP) clinical trial and the subsequent LEAP-On study, both sponsored and co-funded by NIAID.”
  • The HHS OIG issued a report on the inclusiveness of NIH-funded studies.
    • “What OIG Found
      • Two-thirds of the clinical trials in our sample had inclusive enrollment plans, but one-third did not plan to include all racial and ethnic groups.
      • Slightly more than half of clinical trials in our sample were missing required information that would explain the planned target population.
      • Most completed clinical trials in our sample missed planned enrollment targets for underrepresented groups.
      • NIH monitors clinical trial enrollment but has had limited success spurring improvement.
    • W”hat OIG Recommends
      • Hold researchers accountable for clearly describing the rationale for planned study population, as required by NIH policy.
      • Develop additional ways of supporting researchers in meeting inclusion enrollment targets.
      • Promptly take steps to align NIH’s demographic data collection and reporting with the revised OMB requirements and obtain more precise clinical trial inclusion enrollment data.
    • “NIH concurred with the three recommendations.”
  • STAT News reports “Heat waves associated with increased risk of preterm birth in the U.S.”
    • “A new investigation, published on Friday in JAMA Network Open, confirmed the link to early deliveries at a massive scale, in a large cohort study capturing over half of the births that occurred in the United States between 1993 and 2017. Its results shed light on the way existing health inequities may be exacerbated by a worsening climate.
    • “The study looked at more than 53 million singleton births that occurred in the 50 most populous cities in the U.S. during the hottest months of the year. Looking back at heat waves between May and September, researchers counted preterm births (between 28 to 37 weeks of gestation) and early births (between 37 and 39 weeks) within four to seven days of the spike. During that period, there were 2.15 million preterm births, and 5.8 million early births.
    • “After a heat wave, which the study defined as four consecutive days in which the mean temperature was higher than the local 97.5th percentile, preterm births increased by 2%, and early births by 1%. But the distribution of these adverse outcomes was uneven: Mothers who were 29 or younger, had a lower level of education, and belonged to a minority ethnic or racial group saw a 4% increase in preterm births, and a 3% increase in early deliveries.”
  • Medscape seeks to untangle the complex relationship between obesity and cancer.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Merck & Co. is close to a $1.3 billion deal to buy Eyebiotech, a move that would push the big drugmaker into the large and growing market for eye-care. “Merck & Co. is close to a $1.3 billion deal to buy Eyebiotech, a move that would push the big drugmaker into the large and growing market for eye-care. 
    • “Under the terms, Merck would pay the $1.3 billion in cash upfront to acquire the closely held biotech, according to people familiar with the matter. Merck could make an additional $1.7 billion in milestone payments for the company, which goes by the name EyeBio.
    • “The deal could be announced as early as Wednesday, the people said. Merck’s venture arm was an investor in EyeBio. 
    • “EyeBio’s lead drug, Restoret, is in development to treat eye conditions including a form of age-related macular degeneration that leads to blurred vision and potentially blindness. In older people with the disease, known as Wet AMD, a part of the retina wears down, and fluid leaks from blood vessels.” 
  • and
    • “Cancer Is Capsizing Americans’ Finances. ‘I Was Losing Everything.’
    • “Higher drug prices, rising out-of-pocket costs and reduced incomes create economic strain for many patients.”
  • Per BioPharma Dive,
    • “Johnson & Johnson is adding to its portfolio of dual-targeting antibody drugs, announcing on Tuesday a deal to acquire an experimental skin disease medicine for $1.25 billion.
    • “Per deal terms, J&J will buy Yellow Jersey Therapeutics, a spinout newly created by the drug’s developer, Swiss biotechnology startup Numab Therapeutics. The acquisition hands J&J a drug known as NM26 that’s ready for Phase 2 testing in atopic dermatitis, a form of eczema.
    • “In a statement, J&J said NM26 has the potential to offer “distinctive benefits” versus existing treatments for atopic dermatitis, which include Sanofi and Regeneron’s Dupixent and AbbVie’s Rinvoq. The drug targets two proteins, IL-4Ra and IL-31, that are linked to inflammatory diseases.”
  • STAT News relates,
    • “An experimental drug from Insmed Incorporated successfully reduced lung problems among patients with an airway disease in a closely watched Phase 3 trial, sending the company’s share price soaring early Tuesday. 
    • “The drug, brensocatib, reduced so-called pulmonary exacerbations by roughly 20% versus placebo in patients with bronchiectasis, hitting the trial’s primary endpoint. The trial, called the ASPEN study, tested two dosages of the drug, and the company said both significantly cut rates of pulmonary exacerbations.” 
  • Beckers Hospital Review notes,
    • “Novo Nordisk is contesting Sen. Bernie Sanders’ calls to reduce the list prices of Ozempic and Wegovy in the U.S., Bloomberg reports.  
    • “In late April, the Senate Health, Education, Labor, and Pensions Committee, chaired by Mr. Sanders, launched an investigation into Novo Nordisk’s list pricing for GLP-1 drugs. This followed research showing that Ozempic could be manufactured for less than $5 per month, significantly lower than the U.S. list price of nearly $1,000 for a monthly supply.
    • “Mr. Sanders requested information from Denmark-based Novo Nordisk by May 8, but the drugmaker requested an extension to submit its responses. 
    • “In a letter issued to Mr. Sanders May 24, Novo Nordisk said it is prepared to work with lawmakers to address “systemic issues so that everyone who can benefit from its medicines is able to get them,” but argued that focus on its list prices for the drugs is misplaced since it retains about 60% of the list price of Ozempic and Wegovy in the U.S. after rebates and fees are paid to middlemen, Bloomberg reports. 
    • “Novo Nordisk also said that focusing on the cost disparity is unfair because the development of the GLP-1 drugs required billions in upfront investment. The drugmaker said it spent over $10 billion to develop the GLP-1 medicines and that, “under current market conditions, the company expects that net prices will continue to decline for both Ozempic and Wegovy,” Bloomberg reports.”
  • and
    • “Johns Hopkins University Bloomberg Center recently awarded a team of researchers $300,000 to aid them in a “first-of-its-kind” drug supply chain dashboard. 
    • “On May 21, the Washington, D.C.-based college announced $15 million in funding for 40 projects. One of the winning projects is “The Johns Hopkins Drug Supply Chain Data Dashboard: Improving Data Transparency and Increasing Resiliency in the U.S. Pharmaceutical Supply Chain.”
    • “The dashboard “will provide timely insights to tackle drug shortages and supply chain disruptions,” according to Tinglong Dai, PhD, a Johns Hopkins professor of operations management and business analytics who is part of the research team.”
  • HR Dive points out that the recent Fair Labor Standards Act overtime rule changes effective on July 1, 2024. HR Dive shares some its articles about this rule.

Happy Memorial Day!

David Ermer–ACA, CDC, Congress, COVID-19, Medical / Rx research, Obesity, U.S. Healthcare, Uncategorized–

From Washington, DC —

  • Congress is not in session this week of Memorial Day.
  • FEHB and for the first time PSHBP plans must submit their 2025 benefit and rate proposals no later than this coming Friday May 31.
  • The No Surprises Act RxDC reporting deadline for the 2023 calendar year is this coming Saturday, June 1.

From the public health and medical research front,

  • The Washington Post warns us,
    • “Summer offers a reminder of why covid is unlike the flu, a more predictable fall and winter respiratory virus. Coronavirus ebbs and flows throughout the year, and hospitalizations have always risen in summer months when people travel more and hot weather drives people indoors. For now, covid activity is low nationally, the CDC said Friday. The number of Americans dying of covid is less than half what it was a year ago, with a death toll around 2,000 in April. The virus poses a graver threat to the severely immunocompromised and elderly. But it can still surprise younger healthy people, for whom a bout of covid can range from negligible sniffles to rarer long-term debilitating effects. * * *
    • “The CDC and health authorities continue to promote the coronavirus vaccine, last updated in fall 2023 for a subvariant no longer in circulation, as the best form of protection against the disease. Just 23 percent of adults have received a dose of the latest vaccine, the CDC estimates. Experts say the existing formula should still confer protection against severe illness from the FLiRT variants. People 65 and older qualify for a second dose, but only 7 percent have received two shots.”
  • The Post also lets us know,
    • “When asked, 75 percent of survey respondents said they felt mental health conditions are identified and treated worse than physical health issues, according to a new survey from West Health and Gallup.
    • “The poll surveyed a random sample of 2,266 U.S. adults 18 and older. In addition to perceptions about treatment, the survey also gauged mental health conditions among participants. Of the respondents: 51 percent reported experiencing depression, anxiety or another mental health condition in the previous 12 months. * * *
    • “The main barriers, according to those surveyed, were affordability and difficulty in finding an adequate provider. Participants also cited shame and embarrassment as keeping them from treatment. This was particularly felt among participants who had experienced a mental health issue in the past year: 74 percent of those respondents thought people with mental health conditions are viewed negatively. 
    • “Additionally, 75 percent of adults 65 or older thought mental health conditions carry a negative stigma, but 53 percent of the participants felt psychological counseling or therapy is “very effective” or “effective.” Fewer adults felt medication was effective.”
  • Fortune Well tells us,
    • “Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders of childhood, and it’s usually diagnosed in kids. But ADHD tends to be underdiagnosed in women and people of color, which can lead to some people reaching adulthood before realizing they may have the condition.” 
    • The article delves into the signs and symptoms of ADHD in adults and treatment options.
  • Fortune Well also considers,
    • “Could Ozempic be the answer to a longer life?
    • “It’s the question many scientists are asking about the controversial drug, a glucagon-like peptide-1 receptor agonist (GLP-1), as some research suggests it could help humans age with less chronic diseases. The same goes for glucose-dependent insulinotropic peptide receptor agonists (GIP) such as Zepbound and Mounjaro, leaving some experts to start seeing them as potential longevity pills and considering how in the future they can be prescribed safely to more people, especially as rates of obesity continue to rise.
    • “The singular most effective and consistent way of extending lifespan in animals is caloric restriction,” says Dr. Douglas Vaughan, a professor of medicine at Northwestern University and director of the Potocsnak Longevity Institute. “That’s been demonstrated to work on everything from worms to flies to mice to monkeys. If you can find a way to get people to chronically reduce their caloric intake, it sort of makes sense that it might have an effect on aging. It’s probably not as simple as that and there could be unexpected effects of these drugs that might negate or prevent the anti aging effect, but it’s a great hypothesis and it needs to be tested rigorously.”

From the U.S. healthcare business front,

  • Fierce Healthcare notes,
    • “Elevance Health’s philanthropic arm is launching a new initiative that aims to provide loans to small businesses and other organizations in a bid to address health equity.
    • “The Elevance Health Foundation has made a $10 million commitment to the “impact investing” effort, according to an announcement. The loans offered through the program will be offered at below Prime rates, and the partners will deploy the funds to address key social needs like access to care, food insecurity and health disparities.
    • “The foundation also intends to seek out purpose-driven businesses that may not be able to access traditional banking, particularly those owned by women and people of color, who can impact equity in their communities.
    • “Shantanu Agrawal, chief health officer at Elevance Health, told Fierce Healthcare that the foundation has historically offered grant-based programs, which does limit the reach of its work to non-profit organizations. The team “took a step back” and examined other ways it could invest in communities before landing on this loan program, he said.”
  • The Wall Street Journal reports that
    • “the debt-collection spree is an example of how some hospitals in recent years have become more aggressive in recouping bills from the estimated more than 15 million Americans who have medical debt. The issue can be particularly acute in rural areas like Pratt, where residents are more likely to be older and uninsured, and hospitals are under financial stress. 
    • “A nationwide increase in debt-collection cases has drawn scrutiny from some attorneys and judges who say they eat up court and law-enforcement resources. In nine states with easy-to-access court data, debt cases—including those for medical bills, credit cards, and auto and student loans—made up 29% of civil dockets in 2013, compared with 42% in 2021; debt claims were the most common civil cases in 13 of 16 states that year, according to the nonprofit Pew Charitable Trusts.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front,

  • Cybersecurity Dive tells us,
    • “An HHS agency revealed a new cybersecurity program Monday [May 20, 2024,] that aims to better safeguard hospitals as the healthcare sector faces increasing cyber threats that can derail patient care. 
    • “The initiative, which comes out of the Advanced Research Projects Agency for Health, will invest more than $50 million to build a software suite that could automatically scan model hospital environments for vulnerabilities that could be exploited by hackers and quickly develop and deploy fixes.
    • “The project seeks to help hospitals keep their vast array of internet-connected devices up to date, preventing attacks and subsequent technology outages that can last for weeks and threaten patient safety.”
  • American Hospital News adds,
    • “The Universal PatchinG and Remediation for Autonomous DEfense (UPGRADE) program will proactively evaluate potential vulnerabilities by probing for weaknesses in software. When it detects a threat, a patch could be automatically developed, tested and deployed with minimal interruption to hospital devices. 
    • “We applaud HHS’ recognition of the unique challenges and systemic nature of vulnerability management in health care,” said John Riggi, AHA’s national advisor for cybersecurity and risk. “The research which will be empowered through the ARPA-H funding will yield technical solutions which should be applied strategically to help secure the entire sector. It is clear, health care is a critical infrastructure sector, which must not be left to defend itself on its own through uncoordinated and uneven capabilities. Continuing ransomware attacks on the health care sector represent an urgent national security, public health and safety issue. The UPGRADE program is an innovative and welcomed ‘whole of nation’ approach, which will combine the expertise of the health care sector and government experts.” 
  • Cybersecurity Dive informs us,
    • Providers are still looking for clarification on whether they’ll have to report or notify patients about data breaches stemming from the cyberattack against Change Healthcare earlier this year.
    • In a letter sent to HHS Secretary Xavier Becerra Monday [May 20, 2024], more than 50 organizations — including the American Medical Association, the College of Healthcare Information Management Executives and the American Health Information Management Association— urged the federal government to publicly confirm that Change could manage data breach reporting and notification requirements, since the technology firm and major claims processor experienced the breach. 
    • UnitedHealth Group, Change’s parent company, has previously said it would handle reporting for customers whose data may have been exposed — which could be a huge swath of Americans.
  • Bloomberg Law reports,
    • “Companies working with the US government may be required to start protecting their data and technology from attacks by quantum computers as soon as July.
    • “The National Institute for Standards and Technology, part of the Department of Commerce, will in July stipulate three types of encryption algorithms the agency deems sufficient for protecting data from quantum computers, setting an internationally-recognized standard aimed at helping organizations manage evolving cybersecurity threats. 
    • “The rollout of the standards will kick off “the transition to the next generation of cryptography,” White House deputy national security adviser Anne Neuberger told Bloomberg in Cambridge, England on Tuesday [May 21, 2024]. Breaking encryption not only threatens “national security secrets” but also the way we secure the internet, online payments and bank transactions, she added.”
  • The National Institute of Standards and Technology (NIST), announced on May 20, 2024,

From the cyber vulnerabilities and breaches front,

  • Cybersecurity Dive notes yesterday,
    • “On the eve of Memorial Day weekend, threat researchers and incident response teams are quietly preparing for the risk of malicious activity when staffing is minimal and millions of workers will be on the road. 
    • “Critical industries have faced a series of threats from criminal ransomware gangs or nation-state actors for much of 2024, and the unofficial summer kickoff weekend is a prime opportunity for malicious attacks. 
    • “We see attacks and attempted intrusions every day,” Scott Algeier, executive director of the IT-ISAC, said via email.
    • “While there is no specific threat information pointing to a Memorial Day event, “attackers are also aware of the calendar and know that security teams tend to operate with reduced staffing on weekends and holidays,” Algeier said.
    • “While there is no specific threat information pointing to a Memorial Day event, “attackers are also aware of the calendar and know that security teams tend to operate with reduced staffing on weekends and holidays,” Algeier said.”
  • HHS’s Health Sector Cybersecurity Coordination Center (HC3) has issued its April 2024 cybersecurity vulnerability bulletin.
    • In April 2024, vulnerabilities to the health sector have been released that require attention. This includes the monthly Patch Tuesday vulnerabilities released by several vendors on the second Tuesday of each month, along with mitigation steps and patches. Vulnerabilities for April are from Palo Alto, Ivanti, Microsoft, Google/Android, Apple, Mozilla, Cisco, SAP, VMWare, Adobe, Fortinet, and Atlassian. A vulnerability is given the classification of a zero-day when it is actively exploited with no fix available, or if it is publicly disclosed. HC3 recommends patching all vulnerabilities, with special consideration given to the risk management posture of the organization.
  • HC3 also issued a useful PowerPoint presentation titled “Business Email Compromise (BEC) & Healthcare.”
  • The Cybersecurity Infrastructure Security Administration added the following new known exploited vulnerabilities to its catalog:
  • Dark Reading reports yesterday that “Google Discovers Fourth Zero-Day in Less Than a Month; The tech company has rolled out fixes for a type confusion vulnerability that has already been exploited by malicious actors.”
  • Cyberscoop adds
    • “An aggressive, nebulous ring of young cybercriminals linked to a string of recent high-profile breaches is made up of approximately 1,000 people, a senior FBI official said Friday. 
    • “In remarks Friday at the cybercrime-focused Sleuthcon conference, Bryan Vorndran, assistant director of the FBI’s Cyber Division, described the group best known as Scattered Spider as a “very, very large, expansive, disbursed group of individuals,” many of whom don’t know each other directly. 
    • “Scattered Spider emanates from an online community known as “the Com.” The group is also tracked by cybersecurity firms as “0ktapus” or UNC3944, and Vorndran’s remarks provide the best number yet for the total size of the hacking crew.  
    • “Scattered Spider has breached a who’s-who of big-name companies, including the casino giant MGM Resorts and the identity management company Okta. Made up of mostly native English speakers in the United States and the United Kingdom, Scattered Spider is classified as a top three cybersecurity threat, alongside China and Russia’s foreign intelligence agency, Vorndran said.” 

From the cybersecurity defenses front,

  • Modern Healthcare lets us know
    • A recent string of massive healthcare cybersecurity breaches has put data security leaders on edge. 
    • Health system cybersecurity executives are looking at their biggest points of weakness in the aftermath of large-scale breaches at St. Louis-based health system Ascension, UnitedHealth Group’s Change Healthcare and Chicago-based Lurie Children’s Hospital
    • Recent incidents have shined a light on some of the most significant vulnerabilities at health systems. Here are four of the biggest, according to experts.. 
      • Lack of Shared Organizational Goals
      • Third party Vendor Risks
      • Multi-factor Authentication Misses
      • Slow Response Time
  • Similarly MedCity News points out,
    • “During a fireside chat at MedCity News’ INVEST conference, Nitin Natarajan — deputy director at the Cybersecurity and Infrastructure Security Agency (CISA) — shared some key ideas that people need to understand about the current state of cybersecurity in the healthcare industry. For instance, he reminded us that things won’t get better overnight, and that cybersecurity requires an all-hands-on deck approach.”


 

Friday Factoids

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, U.S. Healthcare–

Photo by Sincerely Media on Unsplash

From Washington, DC

  • The U.S. Office of Personnel Management’s proposed supplemental Postal Service Health Benefits Program (PSHBP) rule appears in todays’ Federal Register. The public comment deadline is June 24.
  • The proposed rule includes a requirement that PSHBP annuitants eligible for Medicare Parts A or B must participate in their PSHB plans’ Medicare Part D EGWP. Those who opt out will not be eligible for their PSHB plans’ regular prescription drug benefits. Here is a link to the proposed rule’s preamble where OPM lays out it thought process.
  • Healthcare Dive tells us,
    • “The House Budget Committee met Thursday to discuss the impact of healthcare mergers and acquisitions on cost, quality and access and arrived at a bipartisan consensus: Something needs to be done to halt the rampant pace of consolidation before it inflates medical costs further.
    • “What, exactly, remains unclear, though lawmakers and witnesses during the hearing expressed support for standardizing Medicare payments between hospital-owned outpatient sites and independent physician offices for the same services.
    • “Such site-neutral policies are “very bipartisan,” testified Sophia Tripoli, the senior director of health policy at patient advocacy group Families USA. “It is a no brainer.”
    • “Congress has been increasingly interested in tamping down on healthcare consolidation amid a mountain of evidence it increases costswithout a corresponding increase in care quality, harming Americans’ ability to access and afford medical care. After a merger, hospitals can jack up their prices anywhere from 3% to 65%, according to a Rand review from 2022.
    • “We just can’t afford to have this continued increase in prices,” said Rep. Ron Estes, R-Kan., during the hearing.”
  • BioPharma Dive lets us know,
    • “A top Food and Drug Administration official on Friday again advocated for the speedy approval of gene therapies for rare diseases. But he didn’t drop any clues on where the agency stands on a coming decision to possibly broaden use of one of them, a Duchenne muscular dystrophy treatment the regulator cleared last year.
    • “At a meeting hosted by the patient advocacy group CureDuchenne, Peter Marks, head of the FDA office that reviews gene therapies, said the agency’s thinking has changed in recent years to become more patient focused. That mindset has led it to more aggressively look for ways to speed the development of rare disease gene therapies.
    • “Although we’re a regulatory agency,” he said, the regulations “have to ultimately serve getting products to patients. So we’re trying to focus on the patient, and use that to negotiate the regulations to get there as rapidly as possible.”
    • “Those comments build on points Marks has made before. Last year, at a meeting held by a different advocacy group, he advocated for flexibility in reviewing rare disease gene therapies while fighting off criticism about accelerated approvals, which allow drugmakers to bring therapies to market based on interim measures of benefit. On Friday, he again threw support behind speedy clearances, noting that they are a “very important” tool in bringing forward rare disease treatments.”
  • Tammy Flanagan writes in Govexec about “What is the retirement age for federal employees?”

From the public health and medical research front,

  • The Centers for Disease Control informs us today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare remains low nationally.
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are at low levels.
    • “Nationally, COVID-19, influenza, and RSV test positivity remained stable at low levels compared to the previous week.
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, is minimal.”
  • STAT News reports
    • “Stroke prevalence has been climbing over the past decade, reversing a steady decline among all Americans while rising the most among adults under 65, a new CDC analysis reports.
    • “Strokes still strike more adults older than 65, but the increase at younger ages mirrors another recent turnaround: rates of heart failure deaths, which had been dipping, are rising the most in adults under 45.
    • “The rising prevalence comes even though medicines to tamp down such risk factors as hypertension and high cholesterol, as well as technologies to treat strokes, are much more available in wealthier countries like the U.S. than elsewhere around the world.
    • “Stroke rates in the United States had fallen by 3.7% during a five-year stretch ending in 2010, but they headed back up by 7.8% through 2022. The increase was nearly double — 15% — for adults younger than 65. Thursday’s Morbidity and Mortality Weekly Report broke it down further to a jump of 14.6% among adults age 18 to 44 and 15.7% among those age 45 to 64.”
  • and
    • “Novo Nordisk’s Ozempic cut the risk of death in a trial of patients with type 2 diabetes and chronic kidney disease, suggesting it may offer some added benefits over other classes of drugs approved to treat this population.
    • “Specifically, the diabetes drug cut the risk of cardiovascular-related deaths by 29% and all-cause deaths by 20%. Given the study parameters, this implies that over three years, 39 people would need to be treated to prevent one death from any cause, according to new results presented Friday at a meeting of the European Renal Association and published in the New England Journal of Medicine.
    • “Ozempic also lowered the risk of major heart complications — including cardiovascular-related death, heart attack, or stroke — by 18%, driven primarily by the reduced rate of heart-linked death.
    • “The full results of this trial, called FLOW, affirm the primary result reported earlier this year that Ozempic reduced the risk of major kidney events — including kidney failure, reduction in kidney function, or death from kidney or heart causes — by 24%.”
  • The New York Times relates,
    • “Colorectal cancer rates are rapidly rising among adults in their 20s, 30s and 40s, and the most common warning sign for the disease is passing blood in the stool, according to a new scientific review.
    • “Rectal bleeding is associated with a fivefold increased risk of colorectal cancer, according to the new analysis, which looked at 81 studies that included nearly 25 million adults under 50 from around the world.
    • “Abdominal pain, changes in bowel habits and anemia are other common warning signs of the disease and should not be ignored, said the researchers, who published the paper on Thursday in the journal JAMA Network Open.”

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Eli Lilly plans to spend another $5.3 billion building production capacity for its popular obesity and diabetes drugs, responding to immense demand for the medicines with what it claims is now the largest investment of its kind in U.S. history.
    • “The commitment announced by Lilly Friday adds to $3.7 billion the drugmaker already planned to invest in a manufacturing site it’s constructing in Lebanon, Indiana, some 30 miles from its corporate headquarters in Indianapolis.
    • “The site will help Lilly make the active drug ingredient tirzepatide, which is in its weight loss shot Zepbound and diabetes treatment Mounjaro. Despite pressing hard to expand manufacturing capacity, Lilly has so far had trouble keeping the drugs in steady supply. Certain dose strengths of both products are currently listed as in shortage by the Food and Drug Administration, with limited availability at least through the end of June.”
  • Beckers Behavioral Health points out,
    • “UnitedHealth Group’s Optum has acquired Plymouth, Minn.-based CARE Counseling, the Star Tribune reported May 23. 
    • “CARE Counseling has 10 locations in the Minneapolis area, and employs over 200 clinicians. 
    • “Expanding and diversifying our behavioral health care delivery capabilities through this combination will build on a strong foundation of patient-centered, high-quality and affordable care in an environment that supports and enables the talented clinicians delivering these critical services,” UnitedHealth Group told the Star Tribune. “We look forward to working with CARE Counseling to build on their deep roots in the community.”
  • Reuters reports,
    • “CVS Health Corp (CVS.N), opens new tab has been seeking a private equity partner to fund growth at Oak Street Health, a primary care provider it bought a year ago, Bloomberg News reported on Thursday.
    • “The company has been working with financial advisers to help find capital to back new clinics that will be opened by Oak Street, the report said, citing people familiar with the matter.
    • “The deliberations are in a preliminary stage and the structure could change, while there is no guarantee a deal will be reached, according to the report.”