FEHBlog

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front,

  • Fedscoop reports,
    • “Chris DeRusha is exiting his role as federal chief information security officer after more than three years on the job, the Office of Management and Budget confirmed Tuesday [May 14].
    • “DeRusha, who was appointed to the federal CISO position in January 2021, played a critical role in the development of the White House’s artificial intelligence executive order, in addition to the Biden administration’s 2021 executive order on cybersecurityand the corresponding national cybersecurity strategy and implementation plan.  * * *
    • “As the federal CISO, DeRusha oversaw the 25-member council of his chief information security officer peers and spearheaded the protection of federal networks, while also managing agencywide implementation of multifactor authentication and supporting the coordination of the nation’s broader cybersecurity as the deputy national cyber director. 
    • “DeRusha will also leave behind that role, the Office of the National Cyber Director confirmed.”
  • Cyberscoop adds,
    • “[T]op official at the Cybersecurity and Infrastructure Security Agency, Eric Goldstein, is stepping down from his role at the agency next month.”[T]op official at the Cybersecurity and Infrastructure Security Agency, Eric Goldstein, is stepping down from his role at the agency next month.
    • “As executive assistant director for cybersecurity, Goldstein has had his hands in many of CISA’s major undertakings, from its goal of pressuring companies into making their products secure during the design process to issuing emergency directives for agencies to shoring up defenses against vulnerabilities.”
  • Cyberscoop also offers an interview with Mr. Goldstein.
  • The CISA Director Jen Easterly discusses the “ninth iteration of the national cyber exercise, Cyber Storm. The planners, representing private industry, federal, state, and international government partners, managed an exercise that spanned across the globe to simulate a coordinated cyberattack targeting critical infrastructure. * * * Outcomes from Cyber Storm IX will be published later this year at Cyber Storm: Securing Cyber Space | CISA.

From the cyber vulnerabilities front,

  • Cybersecurity Dive reports,
    • The threat from nation state cyber adversaries with ties to Russia and China is growing more sophisticated and dangerous, National Cyber Director Harry Coker Jr. warned Tuesday [May 14]. International cooperation is required to defend common economic and national security interests, he said in a keynote speech at CyberUK 2024 in Birmingham, England.
    • Coker said Russia has enhanced its capabilities since the beginning of the Ukraine invasion in 2022, which has helped it gain success on the battlefield. 
    • “The Russian cyber threat in 2024 marks a new standard of aggression, persistence and operational agility,” Coker said.
  • The Cybersecurity and Infrastructure Security Agency (CISA) added six known exploited vulnerabilities to its catalog this week.
    • On May 13 —
      • CVE-2024-4671 Google Chromium in Visuals Use-After-Free Vulnerability
    • On May 14 —
      • CVE-2024-30051 Microsoft DWM Core Library Privilege Escalation Vulnerability
      • CVE-2024-30040 Microsoft Windows MSHTML Platform Security Feature Bypass Vulnerability
    • On May 15 —
      • CVE-2014-100005 D-Link DIR-600 Router Cross-Site Request Forgery (CSRF) Vulnerability
      • CVE-2021-40655 D-Link DIR-605 Router Information Disclosure Vulnerability
      • CVE-2024-4761 Google Chromium V8 Out-of-Bounds Memory Write Vulnerability

From the Ascension Healthcare breach front,

  • Here’s a link to the Ascension website about its May 8 “cybersecurity event.”
  • Cybersecurity Dive tracks the state by state impact of the event here.
  • The hospital community is praising Ascension for its transparency per Beckers Hospital Review.
  • Notwithstanding the kudos, Healthcare Dive reports,
    • “Ascension is staring down two proposed class-action lawsuits just one week after a cyberattack took systems offline across its 140-hospital portfolio, forcing the nonprofit system to divert ambulances and pause elective care.
    • “In complaints filed in the District Courts of Illinois and Texas plaintiffs allege Ascension acted negligently by failing to encrypt patient data and said the attack leaves them “at a heightened risk of identity theft for years to come.”
    • “Ascension has not said the attack compromised patient data. However, an investigation remains ongoing.

From the ransomware front,

  • IT Pro examines the Black Basta ransomware variant.
    • “CNN reported that Black Basta was the variant of ransomware used [against Ascension] while Healthcare IT security group Health-ISAC said the group has recently accelerated attacks against the healthcare sector.
    • “In the past month, at least two healthcare organizations, in Europe and in the United States, have fallen victim to Black Basta ransomware and have suffered severe operational disruptions. Taking these latest developments into consideration, Health-ISAC has assessed that Black Basta represents a significant threat to the healthcare sector,” it said.
  • Cybersecurity Dive adds,
    • Microsoft researchers warn that a financially-motivated hacker has misused the company’s Quick Assist client management tool since mid-April in social-engineering attacks, ultimately leading to the deployment of Black Basta ransomware, according to a blog post released Wednesday [May 15]. With Quick Assist, users can remotely connect Windows or macOS with another person.
    • The attacks began using voice phishing, also known as vishing, and led to malicious use of remote-monitoring tools like ScreenConnect or NetSupport Manager, according to Microsoft. The hackers also deployed malware, including Cobalt Strike or Qakbot, before launching the Black Basta ransomware.
    • The disclosure came less than a week after the FBI and Cybersecurity and Infrastructure Security Agency warned about Black Basta ransomware being deployed in hundreds of attacks against critical infrastructure and healthcare worldwide.
  • Cybersecurity Dive further notes,
    • “Remote-access tools were the primary intrusion point for ransomware attacks, accounting for 3 in 5 attacks last year, cybersecurity insurance firm At-Bay said Wednesday [May 15] in a report.
    • “Attackers primarily targeted perimeter-access tools in 2023, but shifted their focus from remote desktop protocol to targeting self-managed VPNs. These on-premises VPNs were linked to more than 3 in 5 ransomware attacks where remote access was the initial entry vector, according to At-Bay.
    • “Attackers go after the same things. If you have a city that has walls around it, you’re going to go after the gate because the gate is a weaker point than the actual wall,” Rotem Iram, At-Bay founder and CEO, said last week at an Axios event on the sidelines of the RSA Conference in San Francisco.”
  • Tech Target offers National Security Agency views on the ransomware front while Politico reports on what happens after a ransomware attack is discovered.
  • Here’s a link to Bleeping Computer’s The Week in Ransomware.

From the cybersecurity defenses front,

  • Here’s a link to Dark Reading’s CISO Corner.
  • Cybersecurity Dive reports,
    • “A once volatile cyber insurance market has stabilized considerably as new companies have entered an increasingly competitive market, helping lower premium costs and raise coverage limits, according to S&P Global Ratings research released last week.
    • “Insurance companies have evolved underwriting methods by incorporating sophisticated tools to assess potential cyber risk with more flexibility and personalization, according to S&P. 
    • “Municipal governments have made significant advances in their ability to manage cyber risk and respond to malicious attacks, too, S&P found. After years of foregoing expensive commercial policies, these local organizations are now incorporating cyber risk coverage, while smaller governments in many cases are joining cyber risk pools.”

Friday Factoids

David Ermer–CDC, Congress, FDA, Generative AI, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Govexec tells us,
    • “The Office of Personnel Management on Thursday introduced a new form of paid leave designed for federal workers to use in connection with instances of domestic violence or other sexual or relationship-based trauma.
    • “In a memo to agency heads, acting OPM Director Rob Shriver said that although the federal government’s paid leave system “was not constructed with concepts of safe leave in mind,” the Biden administration is committed to protecting feds who have undergone relationship-based trauma and their families. * * *
    • “According to a new fact sheet on OPM’s website, the new safe leave will fall into a series of pre-existing leave categories, depending on what the federal employee intends to do while on leave.”
  • The Census Bureau announced,
    • “While the nation’s fastest-growing cities continue to be in Sun Belt states, new population estimates show that some of the top gainers are now on the outskirts of metropolitan areas or in rural areas.
    • “Today’s release of U.S. Census Bureau July 1, 2023, population estimates for cities and towns reveals geographic shifts in population growth compared to pre-pandemic July 1, 2019, estimates.
    • “The estimates also show that, on average, many small and midsize U.S. cities with populations under 50,000 saw relatively higher growth rates in 2023 than in 2019 before the pandemic hit while large cities generally grew at slower rates.
    • “Overall, the most populous cities continued to return to pre-pandemic trends thanks to increased growth rates and smaller population declines.”

From the public health and medical research front,

  • The Centers for Disease Control lets us know today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is low nationally. This week, no jurisdictions experienced moderate, high, or very high activity.
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are at low levels.
    • “Nationally, influenza test positivity decreased and RSV and COVID-19 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.”
  • CNN reports,
    • “Laboratory tests by the US Department of Agriculture haven’t found any H5N1 bird flu virus in raw beef, but they are a good reminder why eating rare hamburgers can be risky.”Laboratory tests by the US Department of Agriculture haven’t found any H5N1 bird flu virus in raw beef, but they are a good reminder why eating rare hamburgers can be risky.
    • “As part of a suite of tests conducted to check safe food handling advice after the detection of H5N1 bird flu virus in dairy cattle, the USDA recently mixed a substitute virus into ground beef and then cooked patties at varying times and temperatures.
    • “Researchers found none of the virus in hamburgers cooked to 145 degrees, roughly the temperature of a medium burger, or well-done burgers cooked to 160 degrees. They did, however, find some live virus in patties cooked to 120 degrees or rare, although the virus was present “at much, much reduced levels,” said Eric Deeble, acting senior adviser for highly pathogenic avian influenza at the USDA.
    • “Whether that small amount of virus could make someone sick is still an unknown.
    • “The USDA already advises consumers to cook ground beef to an internal temperature of 160 degrees, as measured with a food thermometer, to avoid infections from bacteria such as salmonella and E. coli, he noted.
    • “I don’t think that anybody needs to change any of the safe food handling or safe cooking practices that are already recommended,” Deeble said.”
  • BioPharma Dive lets us know,
    • “New data from two late-stage studies of an experimental Bayer drug show it reduced the frequency and severity of common symptoms of menopause, supporting the company’s case for seeking regulatory approval.
    • “The results were disclosed by Bayer Thursday and will be presented at this year’s annual meeting of the American College of Obstetricians and Gynecologists in San Francisco.
    • “Bayer shared the trials’ success in January, but didn’t reveal specific findings. The company also announced positive results from a third Phase 3 study in March, when it confirmed plans to file for marketing authorization of the drug.
    • “Known as elinzanetant, Bayer’s drug would, if approved, compete with a medicine from Astellas called Veozah, which is approved in the U.S. to treat moderate-to-severe vasomotor symptoms caused by menopause.”
  • The New York Times reports,
    • “When a patient with a severe traumatic brain injury is comatose, in intensive care, unresponsive and hooked up to a ventilator, but not brain-dead, when is the time to withdraw life support? A small study on the fates of people in such situations suggests that doctors and patients’ families may make better decisions if they wait even a few days longer than usual.
    • “Often, a doctor sits down with family members within 72 hours of the patient’s admission to intensive care to discuss the patient’s prognosis, and whether they want to keep their loved one alive, or to remove life support.
    • “Experts say that many doctors would describe the outlook as grim — most likely death or severe disability. Reported outcomes of patients who had severe traumatic brain injuries show that most times the decision is to remove life support. The patient dies.
    • “The researchers behind the new study say that their limited data suggests that doctors’ predictions so soon after the injury frequently are wrong.
    • “The study, published Monday in Journal of Neurotrauma, used a national database that included 1,392 traumatic brain injury patients.”
  • The Wall Street Journal points out that “A ‘Digital Twin’ of Your Heart Lets Doctors Test Treatments Before Surgery. Researchers create digital replicas of individual patients’ organs using data from exams and wearable devices: ‘You can run an infinite number of experiments’.”
    • “Kristin Myers, a mechanical engineering professor at New York’s Columbia University, is making digital copies of women’s uteruses and cervixes, hoping this can help in determining how a pregnancy will go. To do this, Myers uses an ultrasound to create 3-D computational models as part of an effort to someday solve the problem of preterm births. 
    • “The idea of digital twins in health is new,” she says. “We can offer better diagnoses. You can run an infinite number of experiments.”  
    • “At the National Cancer Institute, Emily Greenspan, a program director in the informatics and data science program, envisions a novel way to treat oncology patients. Instead of trying a drug and hoping it works, doctors would create a digital twin of the patient to predict how the disease would respond to a certain drug. 
    • “The institute has been working on creating virtual twins for best treatments of lung cancer, for instance. In the next five years the technology will likely become part of clinical decision-making, Greenspan says. 
    • “Predicting the best treatments and screening, these are blue-sky visions,” she said. “There is a lot of foundational research that’s needed.”
  • Amazing.

From the U.S. healthcare business front,

  • Beckers Payer Issues informs us,
    • “Employer adoption of ICHRAs is up 29% since 2023, according to a May 16 report from the HRA Council.
    • “ICHRAs, or individual coverage health reimbursement arrangements, allow employers to offer a defined tax-advantaged contribution used to reimburse premiums for an individual health plan purchased by an employee on their state’s ACA exchange.
    • “Key numbers:
      • “1. ICHRA adoption grew 29% year over year between 2023 and 2024.
      • “2. ICHRAs grew 84% among employers with 50 or more employees.
      • “3. Among employers surveyed, 83% were not able to offer health benefits until they offered an ICHRA or Qualifying Small Employer HRA. 17% of employers switched from traditional group coverage.
      • “4. The number of employees offered a defined contribution health benefit now exceeds 200,000, which does not include dependents — some estimates have said more than 500,000 people are enrolled.”
  • Per Fierce Healthcare,
    • “For women who experience musculoskeletal (MSK) and pelvic health issues, the decline in estrogen during menopause can not only worsen existing symptoms but also trigger new joint, muscle and pelvic health issues.
    • “Research shows 71% of women who go through menopause experience joint and muscle pain.
    • “Digital health company Hinge Health expanded its movement- and behavior-based care to help women alleviate common menopause symptoms such as hot flashes, joint and muscle pain and pelvic floor disorders.             
    • “As part of the new movement-based menopause support offering, a physical therapist-led care team provides individuals with personalized exercise therapy and behavior-based lifestyle modifications. The aim is to alleviate joint and muscle pain, maintain muscle mass and bone density, and address vasomotor symptoms like hot flashes and mood swings, according to the company.
    • “Regular physical activity can reduce the frequency and severity of some disruptive symptoms that occur with menopause,” said Tamara Grisales, M.D., an urogynecologist at Hinge Health. “Exercise-focused programs complement traditional treatments like Hormone Replacement Therapy, providing a holistic approach to managing menopause.”
  • Beckers Hospital Review notes,
    • “Walgreens will sell a low-cost, over-the-counter version of the opioid overdose antidote naloxone, the company said May 15. 
    • “The Walgreens-brand nasal spray medication will retail for $34.99, a lower price than other branded versions of the drug (Narcan) sold by the retailer. The naloxone spray is currently available online and will hit store shelves nationwide by the end of the month.”

Thursday Miscellany

David Ermer–AHRQ, CDC, Congress, FDA, Medical / Rx research, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Hill informs us,
    • “Blockbuster weight-loss drug Wegovy could bankrupt the U.S. health care system unless the price drops, according to a staff report released Wednesday from the office of Senate Health Committee Chair Bernie Sanders (I-Vt.). 
    • “Unless prices dramatically decline, Wegovy and weight loss drugs could push Americans to spend $1 trillion per year on prescription drugs, the report concluded.
    • “Pricing drugs based on their value cannot serve as a blank check, or the sole determinant for how we understand what to pay for essential goods,” the report stated. As important as these drugs are, they will not do any good for the millions of patients who cannot afford them.” 
    • “The report ups the pressure from Sanders on Danish drugmaker Novo Nordisk to lower the price of Wegovy and Ozempic.”
  • The good Senator has a point here. Drug manufacturers need a dose or two of price reasonableness.
  • STAT News reports,
    • “A House subcommittee on Thursday advanced legislation that would extend some pandemic-era telehealth policies in Medicare for two years, bringing the panel’s approach in line with another committee.
    • “During the pandemic, Congress extended flexibilities that changed what kinds of care Medicare beneficiaries could receive over telehealth and where. Originally, the House Energy and Commerce health subcommittee had considered a bill that would have enacted the policies permanently, but amended the legislation Thursday to pare it down to a two-year extension. The bill passed to the full committee unanimously on a 21-0 vote.
    • “The approach is in line with that of another panel, the House Ways and Means Committee, which passed a two-year extension earlier this month. Both bills include similar provisions that would pay for the extension in part through reforms to the way in which pharmacy middlemen operate.”
  • American Hospital Association News shares,
    • “The AHA shared a series of proposals to strengthen rural health care with the Senate Finance Committee for a hearing May 16 titled, “Rural Health Care: Supporting Lives and Improving Communities.” The proposals include policies promoting flexible payment options; ensuring fair, timely and adequate reimbursement; bolstering the workforce; and improving maternal health. During the hearing, several members focused on access to obstetric services and augmenting the number of medical residency slots awarded to rural hospitals. Jeremy P. Davis, MHA, president and CEO of AHA-member Grande Ronde Hospital in La Grande, Ore., and other health care leaders and policy researchers testified.”
  • The Department of Health and Human Services celebrates the Administration’s mental healthcare accomplishments.
  • The New York Times reports,
    • “The Food and Drug Administration on Thursday approved an innovative new treatment for patients with a form of lung cancer. It is to be used only by patients who have exhausted all other options to treat small cell lung cancer, and have a life expectancy of four to five months. * * *
    • “Each year, about 35,000 Americans are diagnosed with small cell lung cancer and face a grim prognosis. The cancer usually has spread beyond the lung by the time it is detected. * * *
    • “The drug tarlatamab, or Imdelltra, made by the company Amgen, tripled patients’ life expectancy, giving them a median survival of 14 months after they took the drug. Forty percent of those who got the drug responded.
    • “After decades with no real advances in treatments for small cell lung cancer, tarlatamab offers the first real hope, said Dr. Anish Thomas, a lung cancer specialist at the federal National Cancer Institute who was not involved in the trial.
    • “I feel it’s a light after a long time,” he added.”
  • Tammy Flanagan, writing in Govexec, discusses FEHB annuitant reactions to Part D EGWP offerings in various FEHB plans for 2024.
  • Federal News Network notes,
    • After a couple years of uncertainty, satisfaction among federal employees is beginning to rise at many agencies.
    • In a preview of the latest Best Places to Work in the Federal Government rankings, out of the top 10 agencies in each of the four categories — large, midsize and small agencies, as well as agency subcomponents — prioritizing employee engagement was the common thread, the Partnership for Public Service said.
    • “At a time when our nation faces both critical challenges and exciting opportunities at home and abroad, an engaged federal workforce is vitally important,” Max Stier, president and CEO of the Partnership for Public Service, said in a statement. “The top-ranked agencies have excelled at keeping their workforces engaged and motivated and, as a result, they are well positioned to deliver results for the public.” * * *
    • “The Environmental Protection Agency, Energy Department, Office of Personnel Management and National Credit Union Administration all moved up in the rankings and increased their overall scores.” 
  • The CDC is promoting its new and improved website.

From the public health and medical research front,

  • The New York Times informs us,
    • “With Pride events scheduled worldwide over the coming weeks, U.S. officials are bracing for a return of mpox, the infectious disease formerly called monkeypox that struck tens of thousands of gay and bisexual men worldwide in 2022. A combination of behavioral changes and vaccination quelled that outbreak, but a majority of those at risk have not yet been immunized.
    • “On Thursday, the Centers for Disease Control and Prevention warned of a deadlier version of mpox that is ravaging the Democratic Republic of Congo and urged people at risk to be vaccinated as soon as possible. No cases of that subtype have been identified outside Africa so far. But the escalating epidemic in Congo nevertheless poses a global threat, just as infections in Nigeria set off the 2022 outbreak, experts said.
    • “This is a very important example of how an infection anywhere is potentially an infection everywhere, and why we need to continue to improve disease surveillance globally,” said Anne Rimoin, an epidemiologist at the University of California, Los Angeles. * * *
    • “The C.D.C. is focusing on encouraging Americans at highest risk to become vaccinated before the virus resurges. The agency’s outreach efforts include engaging with advocacy groups and social media influencers who have broad appeal among the L.G.B.T.Q. community. In December, the agency urged clinicians to remain alert for possible cases in travelers from Congo.”
  • and
    • “Heart disease, diabetes and kidney disease are among the most common chronic illnesses in the United States — and they’re all closely connected.
    • “Adults with diabetes are twice as likely to have heart disease or a stroke compared with those who don’t have diabetes. People with diabetes — Type 1 and Type 2 — are also at risk of developing kidney disease. And when the kidneys don’t work well, a person’s heart has to work even harder to pump blood to them, which can then lead to heart disease.
    • “The three illnesses overlap so much that last year the American Heart Association coined the term cardiovascular-kidney-metabolic syndrome to describe patients who have two or more of these diseases, or are at risk of developing them. A new studysuggests that nearly 90 percent of American adults already show some early signs of these connected conditions.
    • “While only 15 percent of Americans meet the criteria for advanced stages of C.K.M. syndrome, meaning they have been diagnosed with diabetes, heart disease or kidney disease or are at high risk of developing them, the numbers are still “astronomically higher than expected,” said Dr. Rahul Aggarwal, a cardiology fellow at Brigham and Women’s Hospital in Boston and co-author of the study.
    • “The research suggests that people should pay attention to shared risk factors for these diseases early on — including excess body fat, uncontrolled blood sugar, high blood pressure and high cholesterol or triglyceride levels.”
  • BioPharma Dive points out,
    • “An experimental Roche drug helped people with obesity lose an average of nearly 19% of their body weight over six months, after adjusting for placebo, in an early-stage trial, the company said Thursday.
    • “Roche is awaiting additional data from a study of the drug, called CT-388, in people with diabetes as well as obesity. It also didn’t provide specifics on the drug’s side effect profile. CT-388 is currently only in a Phase 1 program involving 96 people. Larger and longer trials are needed before the company can ask the Food and Drug Administration for approval.
    • “Roche acquired CT-388 through a $2.7 billion acquisition of biotechnology startup Carmot Therapeutics in December. The deal was part of a rush by pharmaceutical companies to capture a share of a market estimated to be worth more than $100 billion annually by early next decade.”
  • and
    • “A once-weekly form of insulin being developed by Eli Lilly proved just as effective at controlling blood sugar in adults with diabetes as commonly used daily injections, according to results from two clinical trials that were released by the drugmaker Thursday.”A once-weekly form of insulin being developed by Eli Lilly proved just as effective at controlling blood sugar in adults with diabetes as commonly used daily injections, according to results from two clinical trials that were released by the drugmaker Thursday.
    • “Lilly is betting that its experimental drug, dubbed insulin efsitora alfa, could provide a longer-lasting and more convenient option than daily treatment for managing diabetes. 
    • “With efsitora, we have an opportunity to provide an innovative once-weekly solution that safely achieves and maintains A1C control, reduces treatment burden of traditional daily injections and potentially improves adherence for people with diabetes,” said Jeff Emmick, a senior vice president of product development for Lilly, in a statement on the trial results.” 
  • The National Institutes of Health Director, in her blog, discusses “Speeding the Diagnosis of Rare Genetic Disorders with the Help of Artificial Intelligence.”
  • The National Institutes of Health announced,
    • “People were more likely to develop a type of treatment-resistant hypertension when they experienced adverse effects of economic and social conditions that influence individual and group differences in health status, known as social determinants of health. Additionally, this risk was higher among Black American adults than white American adults, according to a study funded by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.”People were more likely to develop a type of treatment-resistant hypertension when they experienced adverse effects of economic and social conditions that influence individual and group differences in health status, known as social determinants of health. Additionally, this risk was higher among Black American adults than white American adults, according to a study funded by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.
    • “Factors linked to this increased risk included having less than a high school education; a household income less than $35,000; not seeing a friend or relative in the past month; not having someone to care for them if ill or disabled; lack of health insurance; living in a disadvantaged neighborhood; and living in a state with low public health infrastructure. Apparent treatment-resistant hypertension is defined as the need to take three or more types of anti-high blood pressure medication daily and is associated with an increased risk for stroke, coronary heart disease, heart failure, and all-cause mortality.”
  • The U.S. Preventive Services Task Force released a final research plan for “Unhealthy Alcohol Use in Adolescents and Adults: Screening and Behavioral Counseling Interventions.”
  • Beckers Hospital Review alerts us,
    • “In 2023, patient falls were once again the most common sentinel event reported by healthcare organizations, according to a May 15 report from The Joint Commission.
    • “The Joint Commission defines a sentinel event as a patient safety event that results in death, permanent harm, severe temporary harm or intervention required to sustain life.
    • “The accrediting body received 1,411 reports of sentinel events in 2023, on par with the volume reported in 2022. Only a small portion of all sentinel events are reported to The Joint Commission, meaning conclusions about the events’ frequency and long-term trends should not be drawn from the dataset, the organization said.
    • “In total, 96% of healthcare organizations voluntarily reported sentinel events. About 18% of events were associated with patient death, 8% with permanent harm or loss of function, 57% with severe temporary harm and 12% with unexpected additional care or extended healthcare stays.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “One reason U.S. inflation is still high: Increases in prices for procedures to prop open clogged arteries, provide intensive care for newborns and biopsy breasts.
    • “Hospitals didn’t raise prices as early in the pandemic as supermarkets, retailers and restaurants. But they have been making up ground since then. Their increases have contributed to stubbornly high inflation readings from the consumer-price index, which in April increased 3.4% from a year ago. 
    • “Hospital prices specifically jumped 7.7% last month from a year ago, the highest increase in any month since October 2010, the Labor Department said Wednesday. * * *
    • Economists said they expect higher hospital inflation to persist as recent years’ labor-market disruption continues to ripple through wages and health-insurance contracts. 
    • “We’re not expecting much slowing,” said Alan Detmeister, an economist for UBS. “This was a very large shock that we saw in the healthcare industry over Covid, and it takes years for those to pass through to the prices.”
    • Hospital price increases are responsible for about 23% of the growth in U.S. health spending each year, on average, according to an analysis by federal actuaries for the Journal. Health-insurance premiums last year shot up at the fastest rate in a decade. 
    • Premiums rise with health spending. Public employees in California saw premiums increase 11% this year, largely because of rising prices, which alone raised their premiums by 8%, said the California Public Employees’ Retirement System. 
  • Healthcare Finance adds,
    • The Centers for Medicare and Medicaid Services’ January [2024] expansion of the two-midnight rule to include Medicare Advantage plans has contributed to higher inpatient volumes and revenue growth in the first quarter of the year, according to a Strata Decision Technology report.
    • This is because inpatient services have higher reimbursement levels compared to outpatient services and the two-midnight rule concerns inpatient care.
  • Per Fierce Healthcare,
    • “Though held in check by inflation, Cleveland Clinic’s first-quarter operations trickled past last year’s tally thanks to a jump in volumes and revenues.
    • The nonprofit system reported this week a $50.2 million operating gain (1.3% operating margin), as opposed to the prior year’s $32.3 million (0.9% operating margin). Operating revenues rose 10.2% year over year to nearly $3.9 billion while operating expenses followed close behind with a 9.8% increase.
    • “Cleveland Clinic enjoyed “strong demand for both inpatient and outpatient services” during the quarter, management wrote in commentary on its operations. Compared to the prior year, acute admissions rose 6.7%, total surgical cases by 3.7% and outpatient evaluation and management visits by 3.9%.
    • “The system’s 9.4% increase in net patient service revenue was also boosted by rate increases among Cleveland Clinic’s managed care contracts that went into effect with the new year. Additionally, management wrote, “over the last few years, the system initiated national, regional and local revenue management projects designed to improve patient access throughout the system while striving to ensure the safety of patients, caregivers and visitors.”
  • According to Healthcare Dive,
    • “[Philadelphia based] Jefferson Health and [Allentown, PA, based] Lehigh Valley Health Network signed a definitive agreement Wednesday to merge. The health systems expect the deal to close later this summer, pending regulatory approval, according to a press release. Deal terms were not disclosed.”
  • Fierce Healthcare adds,
    • “UnitedHealth Group’s investments in affordable housing have topped $1 billion, with the program a keystone in its overarching strategy to address health equity and disparities.
    • “The company has made investments in housing since 2011 and, in that time, has supported the development of affordable and mixed income units across 31 states and the District of Columbia, creating more than 25,000 homes for people and families who face housing insecurity.
    • “The investments include direct funding from the company as well as those made through Low-Income Housing Investment Tax Credits and Community Reinvestment Act loans, UnitedHealth said. The company has backed both new development and rehabilitation for older locations in urban, suburban and rural markets. * * *
    • “UnitedHealth is tracking the health benefits of these investments and spent two years measuring outcomes against a baseline set by Stewards of Affordable Housing for the Future and the National Affordable Housing Trust. It found that people living in the properties it backed were more likely to receive annual checkups, with 95% having one in the past year.
    • “In addition, residents living in these locations reported better mental health compared to low-income individuals across the country.”

Midweek Update

David Ermer–Congress, COVID-19, FDA, Medical / Rx research, Medicare, Obesity, Telehealth, U.S. Healthcare–

From Washington DC

Photo by Thought Catalog on Unsplash
  • Fierce Healthcare tells us,
    • “U.S. Senators Sheldon Whitehouse and Bill Cassidy want to reform how primary care providers get paid through Medicare, and they also want to hear from the healthcare industry about the best way to do it.
    • “Whitehouse, a Democrat from Rhode Island, and Cassidy, a physician and Republican from Louisiana, introduced a bipartisan bill, the Pay PCPs Act, S. 4338, on Wednesday to better support and improve pay for high-quality primary care providers. 
    • “The legislation serves as a marker for future primary care legislation and is intended to solicit feedback on a number of important policy questions, the lawmakers said. * * *
    • “Whitehouse and Cassidy also issued a request for information for feedback on policy questions. Feedback can be submitted to physician_payment@cassidy.senate.govuntil July 15, 2024.”
  • Govexec informs us about a mark-up of federal employee telework bills at a Senate Homeland Security and Governmental Affairs committee meeting today.
  • Barrons reports,
    • “Social Security recipients could receive a 3.2% raise next year, according to an estimate based on Wednesday’s inflation result. * * *
    • “The Social Security Administration will announce the actual COLA for 2025 in October, once inflation data from the third quarter are complete. The raise will be equal to the percentage gain in the average level of CPI-W for the third quarter of 2024 from the average for the same period in 2023.
    • “In their annual report, the Medicare Trustees estimated that the standard monthly Part B premium could rise to $185 next year, a 5.9% increase from this year’s $174.70. Part B premiums, which are automatically deducted from Social Security checks, are one of the fast-growing costs in retirement, [independent consultant Mary] Johnson says.
  • Plan Sponsor lets us know,
    • “The ERISA Advisory Council voted during a meeting Wednesday to focus its attention on issues related to welfare plan claims and appeals and qualified default investment alternatives. The council will study these issues and make recommendations to the Employee Benefit Security Administration later this year as per its mandate from the Department of Labor. * * *
    • “Members also considered a review of pension death audit service providers in light of the Central States and Special Financial Assistance controversy in which the Central States pension fund received $127 million in SFA funds for 3,479 dead participants. This error occurred because the plan did not have access to the Social Security death master file and the money was repaid. Since death audit providers also lack access to the DMF, there was concern among some members about how an auditor can certify a death audit at all.”
    • In the FEHBlog’s opinion, it is dumbfounding that pension and health benefit plans are not allowed access to the DMF.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The U.S. saw a slight decline in the number of new overdose deaths last year, marking a rare improvement in a still-raging national fentanyl crisis, preliminary federal data show. 
    • “There were about 107,500 overdose deaths in 2023, down 3% from the year before and the first decline in five years, according to estimates from the Centers for Disease Control and Prevention. One factor was fewer deaths pegged to opioids including the nation’s deadliest drug, the potent synthetic fentanyl, the CDC’s preliminary numbers show. 
    • “It’s the direction we want to be going,” said Mary Sylla, director of overdose prevention policy and strategy at the National Harm Reduction Coalition, which advocates for measures such as easy-to-access medicine to reverse overdoses.
    • “I just hope we can continue the trend, and I hope we double-down on the evidence-based interventions that save peoples’ lives,” Sylla said.”
    • FEHBlog note — Amen to that.
  • The Centers for Disease Control announced,
    • “Approximately 4,000 unintentional drowning deaths occur annually in the United States, and demographic disparities exist.
    • “Compared with unintentional drowning death rates in 2019 (pre–COVID-19 pandemic), rates were significantly higher during 2020, 2021, and 2022, with highest rates among children aged 1–4 years, non-Hispanic American Indian and Alaska Native persons, and non-Hispanic Black or African American persons. National survey data revealed that 55% of U.S. adults have never taken a swimming lesson, and swimming lesson participation differed by demographic characteristics.
    • “The U.S. National Water Safety Action Plan provides recommendations for drowning prevention actions, including increasing access to basic swimming and water safety skills training for all persons, which could reduce disparities in unintentional drowning deaths.”
    • FEHBlog observation — Focus on training children aged 1-4 years.
  • MedPage Today notes,
    • “Patients hospitalized with COVID-19 were more likely to die than those hospitalized with influenza during the fall and winter of 2023-2024, according to an analysis of Veterans Affairs data.
    • “Among over 11,000 patients hospitalized for either illness during this past fall and winter, 5.7% of patients with COVID-19 died within 30 days of admission versus 4.24% of patients with influenza, reported Ziyad Al-Aly, MD, of the VA St. Louis Health Care System, and colleagues.
    • “After adjusting for variables, the risk of death in people hospitalized for COVID-19 was 35% higher (adjusted HR 1.35, 95% CI 1.10-1.66), the authors detailed in a research letter in JAMA.”
  • Cardiovascular Business adds,
    • “Heart failure (HF) patients who received a COVID-19 vaccine are significantly less likely to be hospitalized for HF symptoms or die for any reason, according to new data presented at Heart Failure 2024, a scientific congress of the European Society of Cardiology (ESC). 
    • “The analysis included data from more than 651,000 adult Korean residents with HF. The average patient age was 69.5 years old, and 50% were men. Approximately 83% of patients were fully vaccinated against COVID-19, meaning they received two or more doses of an approved vaccine. 
    • “The study’s authors compared 73,559 vaccinated patients with 73,559 unvaccinated patients, matching them 1:1 according to age, sex, comorbidities and other relevant patient attributes. The median follow-up period was six months. 
    • “Overall, COVID-19 vaccination was associated with an 82% lower risk of all-cause mortality, 47% lower risk of hospitalization for HF and 13% lower risk of testing positive for COVID-19. Vaccinated patients also had lower rates of stroke, heart attack, myocarditis/pericarditis and venous thromboembolism during that six-month period.”  
  • Beckers Hospital Review points out,
    • “Ozempic, Mounjaro and other GLP-1s do not increase the risk of surgical complications, according to research published May 14 in Diabetes, Obesity and Metabolism. 
    • “Nearly a year after the American Society of Anesthesiologists recommended patients skip a dose of their GLP-1s — which are medications approved for Type 2 diabetes and weight loss — because of regurgitation and aspiration risks, a review of 130 million patient records found no increased risk. 
    • “GLP-1s can delay gastric emptying, which can minimize the effect of normal fasting rules before elective surgeries. Soon after the ASA published the guidance, surgery departments across the U.S. updated their preoperative care processes to align with the guideline.” 
  • The Washington Post reports,
    • “The Food and Drug Administration this week moved to expand screening for potentially lethal cervical cancer by allowing women to collect test samples themselves, a move that reproductive health advocates view as crucial to stamping out the preventable disease.
    • “For the first time, women will be able to gather samples for testing in private rooms inside offices of primary-care doctors, at urgent-care clinics and even pharmacies — an advance that could presage home testing.
    • “Advocates hope the method will make it easier for women of color and those living in rural and underserved communities to screen for human papillomavirus — HPV — which can lead to a cancer that afflicts 11,000 each year. It comes as the National Cancer Institute has ramped up study of self-collection, partnering with 25 medical schools and cancer centers across the country to gauge use of collecting vaginal samples at home and at health-care facilities. * * *
    • “The collection method was greenlit for the previously approved HPV test Onclarity, manufactured by BD (Becton, Dickinson and Company). The test is expected to be available in summer and will be part of a study of self-collection, the company said in a news release Wednesday.
    • “Roche also received sign off for the self-collection method for its cobas HPV Test, and has been collaborating with the NCI’s study, the company said in a news release. * * *
    • “This literally just opens up another option for a different demographic of people that might not feel comfortable, that might not have access [and] may not have time” to get tested otherwise, said Irene O. Aninye, chief science officer for the Society for Women’s Health Research, a group focused on advancing women’s health and promoting research.”
  • STAT News relates,
    • “Eisai and Biogen said today that they’ve filed an application with the FDA to sell their Alzheimer’s drug Leqembi through an autoinjector for maintenance dosing. That means patients would first go through an initiation phase with the current regimen of IV infusions, but then transition into weekly injections for maintenance.
    • “If approved, this would be a significantly more convenient option for patients, since infusions require patients once every two weeks to travel to a medical facility and receive the infusion for an hour.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Chicago-based CommonSpirit is pushing for change in the dynamics of payer-provider relationships and is “taking a firm stance on contract renewals so payers absorb a share of inflation,” management said in financial documents published May 15. 
    • “The 142-hospital system said one of the most critical levers for health systems to maintain financial stability is to receive the revenue and cash flow they are entitled to for services provided. 
    • “The news comes shortly after CommonSpirit split with Anthem Blue Cross Blue Shield of Colorado. The breakup, which affects commercial and Medicare Advantage members, means 11 of CommonSpirit’s hospitals and more than 40,000 of its patients in the state are now out of network with the insurer. 
    • “It was never our intent to leave the Anthem Blue Cross Blue Shield network, only to work together in good faith toward a balanced agreement,” CommonSpirit said in a statement on its website. 
    • “The system said that it is willing to continue working toward a new agreement with Anthem but its previous proposals “failed to offer terms that fairly reimburse for services provided to its members, and equitably cover the burden to get reimbursed timely and accurately.”
  • Per Fierce Healthcare,
    • “Uber Health will begin rolling out a new solution designed for caregivers this summer, the company announced at its annual product event Wednesday. 
    • “Uber Caregiver will allow individuals to add a caregiver to their Uber profile. That caregiver can then see and spend that person’s health benefits on eligible services, request rides to doctors’ appointments or order groceries. The caregiver will get real-time updates along the way and have access to a chat feature to communicate with the Uber driver as needed.
    • “Individuals will need to use the Uber app to participate. Uber also offers a way for those who need help to request a ride by calling 1-833-USE-UBER from a phone with texting capabilities. The phone line also supports some health benefits cards.”
  • and
    • “Digital maternal health company Babyscripts announced a partnership Tuesday with Lyft Healthcare to offer sponsored rides for people who are pregnant or postpartum and face barriers to transportation.
    • “Though Babyscripts is a digital-first, tele-maternal health company, it acknowledges that pregnant individuals also need in-person care. 
    • “Access is one of the biggest challenges to maternal health and infant health—and a patient’s outcomes can come down to whether or not they go to their doctor appointments,” Anish Sebastian, CEO and co-founder of Babyscripts, said in a statement.”

Tuesday Tidbits

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Govexec lets us know,
    • “The U.S. Postal Service is pausing some of the most controversial reforms to its mailing network as its leadership has agreed to the demands of a growing, bipartisan chorus in Congress. 
    • “The mailing agency has halted its plans to consolidate dozens of processing facilities until at least Jan. 1, 2025, ensuring the network overhaul is paused until after the upcoming presidential election in which millions of Americans will be voting by mail. A large swath of lawmakers across the ideological spectrum have called on Postmaster General Louis DeJoy to delay or cease the changes, some of which would shift the bulk of mail processing across state lines. 
    • “The decision marks a reversal for DeJoy, who just last week remained resolute in defending his vision as the only viable path forward for his agency. He called the issue an existential one, saying his reforms were “what we must continue to do to survive.” 
  • HHS’s Agency for Healthcare Research and Quality posted its March 2024 “NATIONAL HEALTHCARE QUALITY AND DISPARITIES REPORT CHARTBOOK ON PATIENT SAFETY.”
  • Per an FDA press release, “[o]n Monday [May 13], the FDA issued a safety communication to warn patients, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests due to an increased risk of false results. The FDA had also issued a Warning Letter to Cue Health after an inspection revealed that the company made changes to these tests and that the changes reduced the reliability of the test to detect SARS-CoV-2 virus.” 

From the public health and medical research front,

  • The Washington Post reports,
    • “The coronavirus has once again evolved, in a familiar echo of past years. Unlike earlier iterations of the virus, this new variant is not sparking widespread havoc.
    • “The Centers for Disease Control and Prevention said it is monitoring a variant called KP.2 and does not see evidence it causes more severe illness than other strains. Laboratory tests have shown that KP.2 is not causing a surge in infections or transmission, the agency said.
    • “The CDC has identified a second emergent variant, KP.1.1. But it is KP.2 that is leading the pack. Both new variants belong to a group of coronavirus variants dubbed “FLiRT” by scientists. The acronym was coined to describe a combination of mutations found in the spike protein of the SARS-CoV-2 virus. * * *
    • “KP.2 has symptoms similar to earlier versions of the virus, including fever, chills, cough and muscle or body aches.”
    • The current vaccines are effective against KP.2. [“H]ealth experts predict that the new formulation of the coronavirus expected for the fall could offer even stronger protection because it will probably be tailored to thwart the new variant.”
  • Beckers Hospital News informs us,
    • “On average, people taking Novo Nordisk’s weight loss drug Wegovy see a 10% reduction in weight, which is sustained for four years, according to findings from a major trial published May 13.  * * *
    • “Wegovy is tied to a 20% reduced risk of heart attacks and other cardiovascular events — a benefit that was seen across the board, irrespective of how much weight people lost.” 
  • STAT News adds,
    • “Novo Nordisk will test whether its GLP-1 drugs can help people with alcohol-associated liver disease, and, as part of that, will study if the treatments will change the amount of alcohol people drink.
    • “This appears to be the first time the company is getting involved in research to see if the booming class of GLP-1 diabetes and obesity drugs can affect substance consumption, a question that academic researchers have been probing but the pharmaceutical industry has so far avoided.
    • “The nine-month study will try three drugs alone and in combinations against placebo. The primary outcome being tested is change in liver scarring, or fibrosis, and one of the secondary outcomes is changes in alcohol consumption. The news of the study was first reported by Bloomberg.
    • “The medications that will be tested include the blockbuster semaglutide, sold as the diabetes drug Ozempic and obesity drug Wegovy, as well as CagriSema, a drug Novo is developing that combines semaglutide with the dual amylin and calcitonin receptor agonist cagrilintide. A third drug, NNC0194-0499, targets FGF-21, a hormone produced by the liver that plays a role in inflammation.”
  • NIH’s All of Us Program posted its latest newsletter.
  • Per an Institute for Clinical and Economic Research press release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of 3,4-Methylenedioxymethamphetamine-assisted psychotherapy (MDMA-AP; Lykos Therapeutics) for the treatment of post-traumatic stress disorder (PTSD). * * *
    • “Key Clinical Findings
    • “Although ICER attempted to explore the concerns raised about MDMA-AP and the MAPP trials, ICER was not able to assess the extent that bias influenced reporting of benefits or the frequency with which there may have been misreporting of harms. As such, ICER concluded that the current publicly available evidence is insufficient (“I”) to assess the overall net benefit of MDMA-AP. 
    • “Key Cost-Effectiveness Findings
    • “Given the “I” rating, the economic analyses of MDMA-AP in this Evidence Report are only exploratory analyses that provide insights into costs and benefits if it is assumed that the results of the MAPP trials are accurate. ICER did not calculate a health-benefit price benchmark for MDMA-AP.”
  • Benefitfocus released an “Employee Benefits Strategy Playbook for Mental Healthcare.

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “The majority of the nation’s leading for-profit hospital systems by revenue reported net gains during the first quarter led by stronger than expected inpatient volumes.
    • “The boost in inpatient volumes and associated revenue comes just a quarter after providers said they would be betting more heavily on outpatient services to drive growth. 
    • “Increases in inpatient revenues is an area to watch as providers weigh whether and how to adjust their portfolios. Community Health Systems, for example, has been on a selling spree recently in an attempt to deleverage its balance sheets, while HCA Healthcare, Tenet Healthcare and Universal Health Services are expanding services in key markets. 
    • “Should inpatient care utilization continue to rise over multiple quarters, it could influence hospitals’ capital spending, according to research notes from analysts.”
  • BioPharma Dive tells us,
    • “Biosimilars are gaining ground. The IRA could push them further next year.
    • “As commercial momentum builds, coverage incentives for the Medicare market are expected to favor biosimilars in 2025.”
  • Modern Healthcare reports,
    • Behavioral health provider Talkspace rolled out services Tuesday to 13 million Medicare members across 11 states and will expand to 33 million members nationwide by the end of the year.
    • Talkspace services are available to those with traditional Medicare in California, Florida, New York, Ohio, New Jersey, Virginia, Missouri, Maryland, South Carolina, New Mexico and Idaho. The company plans to offer services to Medicare Advantage members later on, as well.

Monday Roundup

David Ermer–CDC, Congress, Medical / Rx research, Obesity, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Fierce Healthcare tells us
    • “A slew of bills targeting enhanced access to care within rural communities have, to the applause of the hospital industry, passed through committee to the full House of Representatives.
    • “The rural care bills that made it through the Ways and Means Committee’s Wednesday markup broadly support the financial stability of designated Critical Access Hospitals (CAHs) and Rural Emergency Hospitals (REH) along with other smaller hospitals serving rural communities [, among other objectives discussed in the article].
    • “These included The Preserving Emergency Access in Key Sites Act of 2024 (PEAKS Act), which expands increased emergency ambulance services coverage for patients served by CAHs; The Rural Hospital Stabilization Act, which authorizes new grants funding for investments into CAHs, REHs and small rural hospitals staving off potential closure; and The Second Chances for Rural Hospitals Acts, which expands the eligibility requirements for low-volume hospitals that wish to become REHs.”
  • Per an HHS press release,
    • “Today, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced the winners of the FentAlert Challenge, which sought innovative ideas from U.S. youth, aged 14-18, to develop a community strategy to educate their peers about fentanyl and fake pills ― and prevent drug overdose deaths. The Challenge supports primary prevention efforts prioritized in the Department of Health and Human Services (HHS) Overdose Prevention Strategy, a key element of the Biden-Harris Administration’s Unity Agenda’s focus on beating the opioid crisis. The Challenge received almost 200 entries from across the country.
    • “The announcement launched National Prevention Week (NPW) (May 12-18), which celebrates the possibilities of prevention science and offers a platform to showcase substance use prevention activities across the country.”
  • Federal News Network lets us know,
    • “The nation’s top doctor is prescribing more attention to federal employees’ mental health and well-being.
    • But now in a hybrid work environment, that task has become remarkably more challenging, U.S. Surgeon General Vivek Murthy said.
    • “I do think that there are a lot of positives to having flexibility to be able to work from home — reduced commute times, time with family, being able to pick your kids up from school, be home for family dinner, while also not sacrificing your work,” Murthy said Thursday during a mental health and wellness event at the Office of Personnel Management. “But I think one of the things we also have to realize is that all of these choices come with trade-offs.”
    • “One of those trade-offs, he said, is that it can become harder to build social connections among coworkers — something that’s crucial for an agency’s operations overall.
    • “When people feel connected to other people in the workplace, that actually positively impacts their creativity, their productivity, and ultimately contributes to their engagement and retention,” Murthy said. “Creating opportunities for people to come back in person periodically, creating more intentional opportunities for people to be able to connect and learn about one another virtually, those become increasingly important when you’re in a hybrid work environment.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Do you know how old your heart is? And does it even matter? 
    • “More online calculators, wearable devices and medical tests are attempting to estimate your heart’s age. The companies and organizations behind the tools say that having insight into your heart health can prompt you to make lifestyle changes to help stave off cardiovascular disease down the road.
    • “It’s an extension of our newfound obsession with “biological age,” the concept that your body, or parts of it, can be physically aging faster or slower than your actual age. And that by knowing those ages, you can take control to live longer and healthier. 
    • “As for the heart, scientists say the tools can be a helpful jumping-off point for conversations with doctors about habit changes or medications before heart disease sets in. 
    • But you should take the results with a grain of salt, doctors and researchers say. The age calculations tend to be imprecise and don’t capture all of your possible risk factors, such as family history, air pollution, pregnancy complications or genetic variations. 
    • “It’s pretending to quantify something for you specifically that is just directionally true,” says Dr. Gregory Katz, a cardiologist at NYU Langone Heart. “It’s based on a true story, but it’s not actually a true story.”
  • Bloomberg Prognosis discusses “advances in treating brain cancer using different forms of immunotherapy — CAR-T, which uses engineered T-cells, and a messenger RNA-based therapeutic vaccine.”
  • Bloomberg also notes,
    • “Patients could wean themselves off blockbuster drugs such as Ozempic or Wegovy without piling the pounds back on, according to a scientific study.
    • “Data [from a small study] presented at the European Congress on Obesity in Venice, Italy on Sunday provides some of the first evidence that it could be possible to stop taking Novo Nordisk’s Ozempic or Wegovy and not regain any weight that has been lost — as long as a healthy lifestyle is maintained. * * *
    • “The Danish study of patients using semaglutide, which is the active ingredient in Ozempic and Wegovy, alongside a weight management program run through the Embla app, suggests that tapering the drug — instead of a hard stop — could potentially prevent weight regain. 
    • “However, just 353 patients were in the sample of patients who stopped semaglutide, which is a small study size. These patients had reached their target weight and reduced their semaglutide dose over nine weeks. Patients continued to lose weight as they tapered, losing an average of 2.1% over the nine weeks. * * *
    • “The combination of support in making lifestyle changes and tapering seems to allow patients to avoid regaining weight after coming off semaglutide,” said Henrik Gudbergsen, lead researcher and Embla’s chief medical officer, in a statement.”
  • STAT News informs us,
    • “Reluctance among dairy farmers to report H5N1 bird flu outbreaks within their herds or allow testing of their workers has made it difficult to keep up with the virus’s rapid spread, prompting federal public health officials to look to wastewater to help fill in the gaps.
    • “On Tuesday, the Centers for Disease Control and Prevention is expected to unveil a public dashboard tracking influenza A viruses in sewage that the agency has been collecting from 600 wastewater treatment sites around the country since last fall.
    • “The testing is not H5N1-specific; H5N1 belongs to the large influenza A family of viruses, as do two of the viruses that regularly sicken people during flu season. But flu viruses that cause human disease circulate at very low levels during the summer months. So the presence of high levels of influenza A in wastewater from now through the end of the summer could be a reliable indicator that something unusual is going on in a particular area.
    • “Wastewater monitoring, at least at this stage, cannot discern the sources — be they from dairy cattle, run-off from dairy processors, or human infections — of any viral genetic fragments found in sewage, although the agency is working on having more capability to do so in the future.”
  • The Washington Post offers Consumer Reports guidance on how to reduce your exposure to plastics in food (and elsewhere).

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Kaiser Permanente kicked off 2024 with $935 million of operating income (3.4% operating margin) and over $2.7 billion of net income when excluding a one-time, $4.6 billion net asset gain from its Geisinger Health acquisition, according to topline first-quarter numbers shared late Friday.
    • “The performance handily outpaces the $233 million operating income (0.9% operating margin) and $1.2 billion bottom line of last year’s opening quarter.
    • “Still, the integrated nonprofit noted that its operating income was still “below historical first-quarter trends leading up to the pandemic” due to industry-wide cost pressures around high utilization, care acuity and elevated goods and services expenses. The top of the year is typically bolstered by the timing of the open enrollment cycle, and then followed by steady revenue but rising expenses, the organization explained.”
  • RAND reports
    • “Prices paid to hospitals during 2022 by employers and private insurers for both inpatient and outpatient services averaged 254 percent of what Medicare would have paid, with wide variation in prices among states, according to a new RAND report.
    • “Some states (Arkansas, Iowa, Massachusetts, Michigan, Mississippi) had relative prices under 200 percent of Medicare, while other states (California, Florida, Georgia, New York, South Carolina, West Virginia, Wisconsin) had relative prices that were above 300 percent of Medicare.
    • “Even as the number of hospitals and insurance claims analyzed has grown across multiple rounds of the RAND Hospital Price Transparency Study the state-level average price has remained above 200 percent of Medicare—from 247 percent of Medicare prices in 2018 to 224 percent in 2020 and to 254 percent in 2022.”
  • Fierce Healthcare also points out
    • “Foley & Lardner released a new state survey of telehealth insurance laws that tracks the changes in the legal landscape from 2019, before the COVID-19 public health emergency, until April 2024.
    • “The survey includes key figures on each state’s telehealth commercial insurance coverage and payment/reimbursement laws.
    • “Nearly all states have adopted a telehealth statute as of April 2024. Of particular note is the number of states that expanded audio-only coverage, states that implemented coverage and payment parity for mental and behavioral health provided via telehealth, and states that passed reimbursement and parity laws.” 
  • Following up on Cybersecurity Saturday, Fierce Healthcare noted earlier today,
    • “Ascension said it is communicating with several government organizations and for the first time referred to its cybersecurity event as a “ransomware incident” in an update posted this weekend. 
    • “The 140-hospital health system said that it is still working to investigate and restore its systems—a process that is “making progress” but “will take time to complete” across each of its care sites. 
    • “In the meantime, the system said it has notified law enforcement and other government bodies including the FBI, the Cybersecurity and Infrastructure Security Agency (CISA) and the Department of Health and Human Services, among others.” 

Weekend update

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

Happy Mothers’ Day!!

From Washington, DC,

  • Roll Call informs us,
    • “Six months after the launch of the Biden administration’s “birthing friendly” designation for hospitals, advocates are questioning the next steps for the tool aimed at incentivizing better care for patients. 
    • “Beginning last fall, hospitals that achieved the designation received an icon on Care Compare, a federal website aimed at helping consumers pick health care providers. 
    • “But it’s not difficult for hospitals to receive the designation, with 2,225 — that is, most eligible hospitals — having received it as of April. 
    • “Of the nearly 1,000 acute care hospitals that didn’t get the designation, more than 800 said they didn’t provide delivery or labor care. 
    • “And only 135 didn’t get the designation because they didn’t meet the requirements of participating in a statewide or national perinatal quality improvement collaborative program.”  

From the public health and medical research front,

  • STAT News reports,
    • “Rick Slayman, the first man to receive a kidney transplant from a genetically engineered pig, has died, according to a statement from his family and Massachusetts General Hospital, where he underwent the historic operation in March.
    • “Our family is deeply saddened about the sudden passing of our beloved Rick but take great comfort knowing he inspired so many,” his family said in the statement released Saturday evening.
    • “The hospital did not say how or when Slayman died. A spokesperson declined to provide further information, citing “privacy issues.”
    • “We have no indication that [Slayman’s death] was the result of his recent transplant,” Mass. General said in the statement. * * *
    • “Slayman’s family also thanked his team of doctors, “who truly did everything they could to help give Rick a second chance.”
    • “Their enormous efforts leading the xenotransplant gave our family seven more weeks with Rick, and our memories made during that time will remain in our minds and hearts,” they said.”
    • RIP and thanks for your courage, Mr. Slayman.
  • The Washington Post lets us know,
    • “A recent analysis found poor survival rates after bone fractures in older adults, with fewer than a third of men and half of women surviving five years after a fracture.
    • “Published in JBMR Plus, the study looked at a cohort of 98,474 Ontario residents age 66 and older who suffered fractures to parts of the body associated with osteoporosis between January 2011 and March 2015. The patients were grouped into sets based on the fracture site and matched to patients with a similar demographic profile but no bone breaks during the study period.
    • “The fracture cohort was mostly female (73 percent), and the median age at fracture was 80. In the year before the fracture, up to 45 percent of the women and 14 percent of the men had been treated for osteoporosis.
    • “The analysis revealed that those within a year of a hip, vertebral or proximal non-hip, non-vertebral fracture were at the highest risk of death. The survival probability was lower for the oldest patients.”
  • STAT News tells us,
    • “An ambitious effort to cure HIV with CRISPR genome editing fell short in an early clinical trial, investigators announced Friday morning.
    • “In the study, run by Excision BioTherapeutics, researchers tried to use the gene editing tool to address a chief reason HIV has been so hard to cure. While antiviral drugs can clear patients of replicating virus, HIV is able to worm its way into a patients’ own DNA in certain cells. If the patient ever stops taking medicines, those cells start pumping out HIV particles and the infection roars back.
    • “Researchers hoped they could send CRISPR to those cells and, by cutting the HIV DNA lurking there at two spots, slice out the virus. In the Phase 1 trial, investigators administered the treatment to five patients. They then took three of them off conventional antiviral treatment.
    • “In all three patients, the virus soon rebounded and they needed to resume antiviral therapy.
    • “Their approach did not work,” said Fyodor Urnov, director of technology and translation at the Innovative Genomics Institute.”
  • Fortune Well explains,
    • Parenting brings many joys, but sleep deprivation is not one of them. So, it’s no wonder that moms and dads are willing to take some drastic measures—in the form of sleep medications—when it comes to getting their kids down for the night.
    • New survey results from Sleep Doctor reveal that 79% of parents have given their child a substance to get them to sleep—with 66% using melatonin, 35% using Benadryl, and 20% turning to prescription sleep aids. Others reported using everything from herbal and over-the-counter aids to CBD, THC, and even alcohol. * * *
    • “Parents are desperate, they’re tired, they’re juggling so many things … and a child having difficulty sleeping just piles onto that,” says Dr. Nilong Vyas, pediatrician, public health specialist, and board-certified sleep expert working closely with Sleep Doctor, which conducted the survey of 1,201 parents in April. * * *
    • “Still, Vyas tells Fortune, “Ideally it’s better to change [bedtime] behaviors and modify them so a child can learn to fall asleep independently, without the need of supplements.”
  • The Wall Street Journal considers how helpful are mental health chatbots.
    • “Interest in mental-health chatbots is rising, fueled by advances in AI’s ability to conduct sophisticated conversations. But how much therapy can they really provide?
    • “Chatbots are still no substitute for a human therapist, researchers say. Not only do some of these tools have trouble helping patients in crisis, they don’t always offer a sufficient level of personalization or provide advice that is guaranteed to be accurate.
    • “Yet researchers are homing in on some of the supporting roles that chatbots and artificial intelligence could play in mental-health care. For instance, chatbots are showing promise in helping people determine whether they need care and connecting them to the proper resources, in lifting people’s moods and in practicing skills taught in cognitive-behavioral therapy. 
    • “There’s an enormous need for innovation in mental-health care,” says Olga Troyanskaya, a computer-science professor and AI expert at Princeton University, who leads Princeton Precision Health, an interdisciplinary initiative that aims to use technology to improve healthcare. At the same time, she says, it’s also important to balance enthusiasm with caution, especially when it comes to using artificial intelligence in mental health.”
  • The Journal also offers general advice on how to talk with a chatbot.

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front,

  • Cybersecurity Dive reports,
    • “The Biden administration plans to pursue a liability framework to hold the software industry accountable for insecure software, according to administration officials and documents released by the Office of the National Cyber Director this week. 
    • “Federal officials said they have taken steps toward a long-stated goal of shifting the security burden away from technology users and onto the industry. 
    • “The administration wants to pursue a plan to create incentives that will help enable long-term investment in cybersecurity and resilience, Nick Leiserson, assistant national cyber director for cyber policy and programs, said during a panel Monday [May 6] at the RSA Conference in San Francisco.
    • “Leiserson cautioned the objective was not to create a liability framework for the purposes of opening up the software industry to lawsuits.
    • “That’s not the point,” Leiserson said during the panel discussion. “The point is to secure investments in secure software development.”
  • and
    • “The Biden administration plans to launch aggressive actions to enhance cyber resilience across key critical infrastructure sectors, including the healthcare and water sectors, which were the targets of significant threat activity in recent months, according to a report released Tuesday by the Office of the National Cyber Director.
    • “The U.S. wants to speed the flow of intelligence sharing and facilitate closer cooperation with the private sector. The administration also plans to enhance its ability to proactively disrupt threat activity and take down malicious actors. 
    • “We are in the midst of a fundamental transformation in our nation’s cybersecurity,” National Cyber Director Harry Coker Jr., said in a statement. “We have made progress in realizing an affirmative vision for a safe, prosperous and equitable digital future, but the threats we face remain daunting.”
  • In that regard, Govinfosecurity adds,
    • “As the Department of Health and Human Services works on a proposed update to the HIPAA Security Rule this year, regulators are also ratcheting up enforcement efforts – including resuming long-dormant HITECH Act HIPAA audits, said Melanie Fontes Rainer, director of HHS’ Office for Civil Rights. * * *
    • “HHS OCR plans by the end of the year to publish a proposed update to the HIPAA Security Rule to better reflect the evolution of technology and healthcare delivery that’s occurred over the last two decades since the regulations were first issued, she said.
    • “The beauty of the HIPAA Security Rule is that it’s 20 years old – it is technology-neutral, and it’s scalable. So we’re still able to use it and enforce the law vigorously,” she said in a video interview with Information Security Media Group. 
    • “But at the same time, “the downside of the HIPAA Security Rule is that it’s 20 years old and doesn’t reflect how we receive healthcare today,” she adds. “That’s why we’re taking a look at it to make sure we’re building into it practices – like end-to-end encryption – and things like that.”
  • Cyberscoop reports,
    • The U.S. and British governments on Tuesday [May 7] identified Dmitry Yuryevich Khoroshev as the leader, developer and administrator of the LockBit ransomware operation, one of the most prolific and profitable cybercriminal syndicates in recent years.
    • Khoroshev, a Russian national, has been LockBit’s main administrator and developer since at least September 2019 continuing through the present, U.S. federal prosecutors said in an indictment unsealed Tuesday. Since its inception, LockBit has been used in attacks against more than 2,500 targets in at least 120 countries, leading to at least $500 million in ransom payments to Khoroshev and his affiliates and “billions of dollars in broader losses, such as revenue, incident response, and recovery,” the Department of Justice said in a statement.
  • Dark Reading points out that at the RSA Conference “CISA courted the private sector to get behind CIRCIA Reporting Rules. New regulations will require the private sector to turn over incident data to CISA within three days or face enforcement. Here’s how the agency is presenting this as a benefit to the entire private sector.”

From the cyber breaches and vulnerabilities front,

  • Cyberscoop reports,
    • Ascension, a health care system with 140 hospitals in 19 states and Washington, D.C., and tens of thousands of employees and affiliated providers, detected a “cyber security event” Wednesday [May 8] that has caused a “disruption to clinical operations,” the company said. 
    • Major impacts to medical services have been reported in multiple states, including Kansas, Florida and Michigan, including some patients being diverted to other hospitals and lack of access to digital records.
    • “We have to write everything on paper,” one physician in Michigan told the Detroit Free Press. “It’s like the 1980s or 1990s.”
  • Dark Reading adds,
    • “The provider has temporarily paused non-emergency medical procedures and appointments, and some hospitals are diverting emergency medical services. Patients were advised to bring relevant medical information to appointments due to system limitations.
    • “We are actively supporting our ministries as they continue to provide safe, patient care with established downtime protocols and procedures,” a company statement said. “It is expected that we will be utilizing downtime procedures for some time.”
    • “The organization has tapped incident response help from Mandiant for investigation and remediation efforts. It is unknown if any patient data was exposed in the attack.
    • “We are working to fully investigate what information, if any, may have been affected by the situation,” Ascension said. “Should we determine that any sensitive information was affected, we will notify and support those individuals in accordance with all relevant regulatory and legal guidelines.”
  • Cybersecurity Dive tells us,
    • “The FBI and Cybersecurity and Infrastructure Security Agency urged software companies to eliminate directory traversal vulnerabilities from their products, citing a rise in attacks against critical industries, including hospitals and school operations, in a secure by design alert released Thursday. 
    • “The agencies are seeking industry action following two recent campaigns where threat groups engaged in extensive exploitation activity. The agencies referenced a path traversal vulnerability in ConnectWise ScreenConnect, listed as CVE-2024-1708, and a vulnerability in the file upload functionality of Cisco AppDynamics Controller, listed as CVE-2024-20345.
    • “In total, directory traversal or path traversal vulnerabilities were identified in 55 different cases listed on CISA’s Known Exploited Vulnerabilities catalog, according to the alert.”

From the ransomware front,

  • American Hospital Association News informs us,
    • “The Federal Bureau of Investigation, Cybersecurity and Infrastructure Security Agency, Department of Health and Human Services, and Multi-State Information Sharing and Analysis Center May 10 released a joint cybersecurity advisory to provide information on Black Basta, a ransomware variant whose actors have encrypted and stolen data from at least 12 out of 16 critical infrastructure sectors, including the health care and public health sector.”
  • Bleeping Computer’s The Week in Ransomware is back this week.

From the cybersecurity defenses front,

  • Cybersecurity Dive calls attention to the fact that “Officials see a real change in Microsoft’s security plans: financial accountability. CISA Director Jen Easterly pointed to Microsoft’s decision to link security to executive compensation as a meaningful signal of its priorities.”
  • Tech Target offers “five tips for building a cybersecurity culture at your company.”
  • Dark Reading considers the future path of CISOs while the ISACA Blog notes “A Better Path Forward for AI By Addressing Training, Governance and Risk Gaps.”
  • Finally, SC Media dives into the cybersecurity insurance market.

Friday Factoids

David Ermer–CDC, Congress, COVID-19 vaccine, Employee Wellness Programs, FDA, Generative AI, Medical / Rx research, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Govexec reports,
    • “In the face of mounting pressure from lawmakers of all political stripes, watchdogs, stakeholders and even members of its own governing board, as well as another financial quarter in the red, leadership of the U.S. Postal Service is doubling down on its controversial plan to overhaul the agency. 
    • “USPS posted a net loss of $1.5 billion in the second quarter of fiscal 2024, though management noted that was trimmed to a $300 million loss after dispensing with costs outside of its control. USPS leaders boasted they have turned a $200 million profit in the first half of the fiscal year using that same metric, which marked a $600 million turnaround compared to the first six months of fiscal 2023.
    • “While First-Class mail volume has continued its longstanding decline, revenue grew in the quarter by nearly $500 million due in large part to the dramatic price increases USPS has instituted. The Postal Service has cut $100 million in costs, driven largely by a reduction in transportation expenses and slashing 9 million work hours. 
    • “On-time delivery of mail, however, has plummeted as USPS has instituted significant reforms to its network as laid out in Postmaster General Louis DeJoy’s 10-year Delivering for America plan.” 
  • HHS posted a fact sheet on new government efforts to reduce the impact of spread of avian flu H5N1
  • Senators John Fetterman (D PA) and Tina Smith (D MN) announced a bill, “the United States Senate Commission on Mental Health Act of 2024. The bill would establish a U.S. Senate Commission on Mental Health tasked with providing Congress and the president independent, expert policy recommendations to improve access to and affordability of mental health care services. * * * Full text of the bill can be found here.“

From the public health and medical research front,

  • The Centers for Disease Control tells us today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare continues to decrease across most areas of the country. This week, no jurisdictions experienced moderate, high, or very high activity.
    • “Nationally, emergency department visits with diagnosed influenza are decreasing. Emergency department visits with COVID-19 and RSV remain stable at low levels.
    • “Nationally, influenza and RSV test positivity decreased compared to the previous week. COVID-19 test positivity remained stable at low levels.
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, is minimal.”
  • STAT News reports “Harvard scientists unveil the most detailed map of the brain ever: ‘It’s an alien world inside your own head’”.
    • “On Thursday, [Dr. Jeffrey’ Lichtman and his partners unveiled the results of their [decade long] efforts in the prestigious journal Science, and also posted to the internet renderings of the human brain unlike any ever seen. They came complete with a program that allows viewers to move through a microscopic alien landscape so detailed Lichtman can’t resist waxing poetic when he talks about it.
    • “It’s an alien world inside your own head,” he said. “Neurons themselves are truly awe inspiringly beautiful. There’s no two ways about it.”
    • “True, the insights gleaned from the tiny sample have not yet unraveled the mysteries of autism, schizophrenia, or depression. They can’t yet explain the mechanics of human learning, memory, and personality on the cellular level. But they represent an important first step in that direction, and provide a tantalizing preview of the kind of insights we might see in the decades ahead.”
  • The Wall Street Journal reports,
    • “Bristol Myers Squibb said on Friday that its trial evaluating a combination of cancer treatments failed to meet its primary endpoint.
    • “The company’s trial was evaluating the cancer-drug Opdivo and concurrent chemoradiotherapy, followed by Opdivo plus Yervoy, the brand name for a monoclonal antibody, in treating unresectable, locally advanced non-small cell lung cancer. The trial’s primary endpoint was progression-free survival.
    • “Bristol Myers Squibb said it would fully evaluate the data and work with investigators to share results with the scientific community.
    • “Opdivo and certain combinations with Opdivo are approved treatments for eligible patients with non-small cell lung cancer.”
  • Per Fierce Healthcare,
    • “Cancer diagnoses are on the rise among younger adults, and a new guidebook seeks to arm employers with the tools necessary to tackle this issue.
    • “The Northeast Business Group on Health’s new toolkit highlights actions employers can take to proactively address growing rates for five types of cancer in their workforce: breast cancer, colorectal cancer, head and neck cancer, cancer of the reproductive organs and skin cancer.
    • “There’s a clear business case for putting a focus on cancer, as the cost of therapies continues to increase and patients often require treatment for the long haul, NEBGH Medical Director Mark Cunningham-Hill, M.D., told Fierce Healthcare.
    • “He said that many employers, especially larger firms, have established sophisticated and comprehensive wellness and health programs for their workers. But they can do more to “connect the dots” between those offerings and critical preventive care around cancer and conditions that increase risk factors, like obesity.”
  • USA Data relates,
    • One out of every 42 babies born in the United States in 2021 was conceived using IVF or other assisted reproductive technologies.  
    • Parents who started treatments in 2021 gave birth to 97,128 babies, a 49% increase from 2012. In 2021, 238,126 patients initiated 413,776 IVF or similar treatment cycles, up 135% from 2012. 
    • IVF was most common in Washington, DC, with 5.8% of babies conceived via IVF, Massachusetts (5.4%), and New Jersey (5.0%). Less than one percent of infants born in Puerto Rico were conceived via IVF (0.4%). Alabama (0.6%) and Arkansas (0.7%) also had low rates.  

From the U.S. healthcare business front,

  • The Kaiser Family Foundation released a “KFF Health Tracking Poll May 2024: The Public’s Use and Views of GLP-1 Drugs.” Here are the key finding from the poll:
    • “The latest KFF Health Tracking Poll finds that about one in eight adults (12%) say they have ever taken a GLP-1 agonist – an increasingly popular class of prescription drugs used for weight loss and to treat diabetes or prevent heart attacks or strokes for adults with heart disease – including 6% who say they are currently taking such a drug. The share who report ever taking these drugs rises to four in ten (43%) among adults who have been told by a doctor that they have diabetes, a quarter who have been told they have heart disease, and one in five (22%) who have been told by a doctor that they are overweight or obese in the past five years1. Public awareness of GLP-1 drugs has increased in the past year, with about one-third (32%) of adults now saying they have heard “a lot” about these drugs, up from 19% in July 2023.
    • “Most adults who have taken GLP-1 drugs say they took them to treat a chronic condition including diabetes or heart disease (62%), while about four in ten say they took them primarily to lose weight.
    • “About half (54%) of all adults who have taken GLP-1 drugs say it was difficult to afford the cost, including one in five (22%) who say it was “very difficult.” While most insured adults who have taken these drugs say their insurance covered at least part of the cost, even among insured adults about half (53%) say the cost was difficult to afford2.
    • “While 8% of adults ages 65 and older say they have taken a GLP-1 medication for a chronic condition, just 1% say they have ever taken a GLP-1 drug to lose weight, which may reflect Medicare’s lack of coverage for prescription drugs used for weight loss. Nearly four in ten (37%) adults ages 65 and older report being told by a doctor they are overweight or obese in the past five years.
    • “With Medicare currently prohibited by law from covering prescription drugs used for weight loss, six in ten adults say they think Medicare should cover the cost of these drugs when prescribed for weight loss for people who are overweight, including more than half of Democrats, independents and Republicans. Similar shares of the public continue to support Medicare coverage of these drugs for weight loss even after hearing arguments for and against this proposal.”
  • Per BioPharma Dive,
    • “Sanofi will pay vaccine maker Novavax $500 million and take a small equity stake in the Maryland-based company as part of a broad COVID-19 shot alliance, the companies announced Friday.
    • “Through the deal, Sanofi will gain rights to co-market Novavax’s protein-based COVID vaccine globally, excepting certain countries, and a license to combine it with Sanofi’s existing influenza shots. Sanofi will also hold a non-exclusive right to use Novavax’s soap bark tree-derived adjuvant in other products it develops.
    • “Starting next year, Sanofi will book sales of Novavax’s COVID shot and pay Novavax double-digit percentage royalties. The French pharmaceutical company will also support certain R&D, regulatory and commercial expenses.”
  • Per MedTech Dive,
    • “Tandem Diabetes Care is recalling a version of its t:connect app for iPhone because of a fault that could drain insulin pump batteries, the Food and Drug Administration said Wednesday.”Tandem Diabetes Care is recalling a version of its t:connect app for iPhone because of a fault that could drain insulin pump batteries, the Food and Drug Administration said Wednesday.
    • “After updating the app in February, Tandem received 224 injury reports in about two months. The reports related to an issue that caused the app to crash and relaunch, resulting in excessive use of Bluetooth and potentially draining the battery of the connected insulin pump.
    • “The FDA categorized the event as a Class I recall because of the life-threatening potential for pumps to deliver too little insulin. Tandem corrected the fault in an app update in March.”
  • The Wall Street Journal explains why “Getting Alzheimer’s treatment to those who need it poses particular challenges.” For example
    • “The problem isn’t this drug. Sure. It has risks, et cetera,” said Jason Karlawish, co-director, of the Penn Memory Center at the University of Pennsylvania. “But the problem was the drug and the system — namely with a system of care for its delivery.”
    • “Karlawish said his memory center infused its first patient with Leqembi on November 16. He said that in the six months since, the number of patients who have received the drug there has climbed into the double-digits, reaching roughly 50 people. That, he said, required setting up an infrastructure that “either didn’t exist or existed in bits that had to be put together.”
  • MedCity new points out,
    • “Navigation challenges are the top reason consumers stop seeing healthcare providers, while experience issues are the main reason consumers leave their health insurer, a new survey found.
    • “The Accenture report, released last week, surveyed more than 9,700 insured consumers and 8,000 consumers who sought or received care in the prior year. The survey is a follow-up to a 2021 report, which examined why people are loyal or not loyal to their payer or provider.
    • “We wanted to leverage our patient and member experience surveys to continue to track the state of consumerism in health care, assessing how providers and health insurers perform across a number of key touchpoints that drive selection, loyalty, value and ease of use,” said Sarah Sinha, a managing director in Accenture’s health business, in an email.”
  • Insurance Business tells us,
    • “Offering support across a variety of functions including customer service, claims processing, underwriting, and fraud detection, the capability of AI to analyze large datasets and process information will continue to revolutionize insurance.
    • “Nirmal Ranganathan, vice president of engineering, AI, at Rackspace Technology, spoke with Insurance Business on how insurance companies can take advantage of AI to generate cost savings across their businesses.”
    • Check it out.

Thursday Miscellany

David Ermer–Congress, COVID-19 vaccine, Federal employment benefits, HSA, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “The House overwhelmingly voted to table Rep. Marjorie Taylor Greene’s attempt to oust Speaker Mike Johnson on Wednesday night, with nearly all Republicans and most Democrats coming to Johnson’s rescue.
    • “The final tally was 359-43, with 11 Republicans and 32 Democrats voting against the motion to table Greene’s resolution. Seven Democrats voted “present.”
  • The Society for Human Resource Management tells us,
    • “The annual limit on HSA contributions for self-only coverage in 2025 will be $4,300, a 3.6 percent increase from the $4,150 limit in 2024, the IRS announced May 9. For family coverage, the HSA contribution limit will jump to $8,550, up 3 percent from $8,300 in 2024.
    • “The jump in the contribution limits is significantly less than the roughly 7 percent increase seen from 2023 to 2024.
    • “The IRS did not yet release the 2025 catch-up contribution for savers age 55 and older. It currently stands at $1,000 for 2024, unchanged from 2023.
    • “Meanwhile, for 2025, a high-deductible health plan (HDHP) must have a deductible of at least $1,650 for self-only coverage, up from $1,600 in 2024, or $3,300 for family coverage, up from $3,200, the IRS noted. Annual out-of-pocket expense maximums (deductibles, co-payments and other amounts, but not premiums) cannot exceed $8,300 for self-only coverage in 2025, up from $8,050 in 2024, or $16,600 for family coverage, up from $16,100.
    • “The IRS also announced that the excepted-benefit HRA limit will be $2,150 in 2025, up from $2,100.”
  • Here’s a link to the IRS announcement.
  • Fierce Healthcare points out,
    • “The U.S. Department of Justice announced Thursday it has established a new task force to take on healthcare monopolies and collusion.
    • “The task force, called HCMC for short, will guide the division’s enforcement strategy and policy approach in healthcare, including by facilitating policy advocacy, investigations and, where warranted, civil and criminal enforcement in healthcare markets, the agency said in a press release.”
  • Govexec lets us know,
    • “The Office of Personnel Management continued to make gains in its backlog of federal employees’ pending retirement applications, though progress has begun to slow.
    • “The federal government’s dedicated HR agency processed 7,647 claims in April. That marks a sharp decrease from the 10,711 claims handled in March but remains above the 6,901 new claims OPM received last month.
    • “Overall, the backlog of pending claims ticked down to 16,077 by the end of April, a decrease of roughly 750 from March’s backlog of 16,823. The federal government’s retirement backlog has fallen 23% since January, but remains short of OPM’s “steady state” goal of 13,000 pending claims.”
  • Fedweek explains the circumstances under which an FEHB enrollee can make coverage changes outside of Open Season. Meanwhile, Reg Jones wraps up his series on FEGLI coverage.

From the public health and medical research front,

  • “U.S. Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a white paper detailing proposals to improve the National Institutes of Health (NIH). Last year, Cassidy requested feedback from stakeholders on policies Congress could consider to modernize NIH.  * * * Read the full white paper here.  
  • The NIH Director in her blog lets us know,
    • “Precision oncology, in which doctors choose cancer treatment options based on the underlying molecular or genetic signature of individual tumors, has come a long way. The Food and Drug Administration has approved a growing number of tests that look for specific genetic changes that drive cancer growth to match patients to targeted treatments. The NCI-MATCH trial, supported by the National Cancer Institute, in which participants with advanced or rare cancer had their tumors sequenced in search of genetic changes that matched them to a treatment, has also suggested benefits for guiding treatment through genetic sequencing. But there remains a need to better predict treatment responses for people with cancer.
    • “A promising approach is to analyze a tumor’s RNA in addition to its DNA. The idea is to not only better understand underlying genetic changes, but also learn how those changes impact gene activity as measured by RNA sequencing data. A recent study introduces an artificial intelligence (AI)-driven tool, dubbed PERCEPTION (PERsonalized single-Cell Expression-based Planning for Treatments In ONcology), developed by an NIH-led team to do just this.1 This proof-of-concept study, published in Nature Cancer, shows that it’s possible to fine-tune predictions of a patient’s treatment responses from bulk RNA data by zeroing in on what’s happening inside single cells.”
  • NIH announced,
    • “Starting people with opioid use disorder on extended-release, injectable naltrexone (XR-naltrexone) within five to seven days of seeking treatment is more effective than the standard treatment method of starting within 10-15 days, but requires closer medical supervision, according to results from a clinical trial(link is external) supported by the National Institutes of Health’s (NIH) National Institute on Drug Abuse (NIDA). Published in JAMA Network Open, the findings suggest that this rapid treatment protocol could make XR-naltrexone more viable as a treatment option for opioid use disorder, which continues to take lives at an alarming rate.
    • “When someone is ready to seek treatment for opioid use disorder, it is crucial that they receive it as quickly as possible,” said Nora Volkow, M.D., NIDA director. “This study paves the way for more timely care with one of the three medications for opioid use disorder we have available, better supporting people in their ability to choose the treatment option that will work best for them.”
  • The U.S. Preventive Health Task Force made available for public comment a draft research plan about the “Early Introduction of Allergens to Prevent Food Allergies in Infants: Counseling.” The comment period ends on June 5, 2024.
  • The Institutes for Clinical and Economic Review
    • “released a Draft Evidence Report assessing the comparative clinical effectiveness and value of imetelstat (Geron Corporation) for the treatment of anemia in myelodysplastic syndrome (MDS).
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.”
    • The comment deadline is June 10, 2024.
  • The Wall Street Journal explores the quest for treatments to keep weight off after taking blockbuster drugs such as Ozempic and Wegovy. Reading the article makes the FEHBlog think that that the drug manufacturers put the cart before the horse.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Some 23% of what patients owe is collected by hospitals before treatment, according to an analysis of first-quarter data this year from 1,850 hospitals by Kodiak Solutions, a healthcare consulting and software company. For the same period in 2022, the figure was 20%.
    • “They are seeking advance payment for nonemergencies, they say, because chasing unpaid bills is challenging and costly. Roughly half the debt hospitals wrote off last year was owed by patients with insurance, the Kodiak analysis found.
    • “We need those patients who are able to pay to do so,” said Leslie Taylor, a spokeswoman for University of Arkansas for Medical Sciences, which owns one general hospital in Arkansas and will—after discussing with doctors—reschedule some procedures until patients can pay.
    • “For patients, the hospitals say, knowing the cost ahead of service gives them the opportunity to comparison-shop and avoid getting walloped with a huge bill unexpectedly. * * *
    • “Still, finding money for treatment is a challenge for many American households. Half of adults say they can’t afford to spend more than $500 on medical care should they be suddenly sick or injured, a survey by health policy nonprofit KFF found. They would need to borrow. 
    • “In addition, determining how much a patient will owe can be tricky. How much each patient pays depends on their health plan, its deductible or other out-of-pocket costs and the prices the plan negotiated with a hospital to pay.” 
  • Fierce Healthcare relates that doctors are trying to add a CPT code for prior authorization which would give them health plan reimbursement for this administrative services.
  • MedTech Dive alerts us that “Surgical robots are ‘gift that will keep on giving,’ ortho firms say. Stryker, Zimmer and Globus reported double-digit sales growth in their robot segments and outlined plans for new products.”
    • “Orthopedics companies posted record robot sales in the first quarter, even as they plan new product launches in the second half of 2024.
    • “Stryker reported record installations of its Mako surgical robot in the first quarter, although it didn’t share an exact number. Jason Beach, Stryker’s vice president of finance and investor relations, said the company has seen “really good results” from direct-to-consumer ads promoting the surgical robot to people who might consider a hip or knee replacement.” 
  • Per BioPharma Dive,
    • “AstraZeneca will no longer manufacture or supply its COVID-19 vaccine Vaxzevria, announcing Tuesday it is voluntarily withdrawing the shot due to a “decline in demand,” a spokesperson wrote in an email to BioPharma Dive. 
    • “Prior to the announcement, the company had already taken steps to pull Vaxzevria from the market in Europe. It submitted a withdrawal request there in March which took effect on May 7. 
    • “The decision to withdraw the vaccine comes just after the company reported plummeting yearly sales for Vaxzevria, and reportedly admitted in court documents that the shot can cause a rare side effect that leads to a combination of blood clots and low platelet levels. AstraZeneca didn’t mention safety concerns as a reason for the vaccine’s withdrawal, however.”