FEHBlog

Midweek Update

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

From Washington, DC,

  • Kevin Moss, writing in Govexec, explains the pros and cons of Medicare Part D coverage for FEHB annuitants over age 65. The key point is that for 2025 the Medicare Part D out of pocket maximum is $2000. Also, Part D members with higher Part D cost sharing can spread out the Part D cost sharing over the plan / calendar year using Medicare Part D’s new Medicare Prescription Payment Plan (MPPP). The MPPP savings coupled with the $2000 out of pocket max could make Part D valuable for folks who otherwise would use manufacturer coupons.  
  • Although not discussed in the Govexec article, Postal Service Health Benefit (PSHB) annuitants over age 65 generally will be required to use the PSHB plan’s Part D EGWP. Those who opt out are ineligible for the PSHB plan’s regular Rx benefits, and there’s no concomitant premium reduction. We are waiting for OPM’s final supplemental PSHB rule which will include the Part D opt out penalty details.
  • Politico discusses a Biden Harris administration initiative to subsidize standalone Part D plans with a a $15 per Part D member payment to stabilize Part D premiums in consideration of these significant Part D improvements. The article observes,
    • “The Part D market has two types of plans. One is a standalone plan that only offers drug coverage, and the other is coverage included in a privately run Medicare Advantage plan that covers other health services.
    • “Medicare Advantage plans can absorb higher costs better than a standalone option, according to a 2023 analysis from the consulting firm Avalere Health.
    • “Since a Medicare Advantage plan offers a wide array of both medical and drug benefits, it can spread out the cost impact. Standalone plans do not have such flexibility, and the law is causing some to exit the market.”
  • It’s worth noting that Part D EGWPs absorb the basic Part D premium typically charged to the Medicare beneficiary. Part D EGWPs do not absorb the extra IRMAA tax on high income Medicare beneficiaries.
  • Last week, the Centers for Medicare and Medicaid Services released 2025 enrollment and disenrollment guidance for Medicare Advantage and Part D plans.
  • KFF adds,
    • “Among the 167 million people with employer-sponsored insurance in 2022, 3.4 million used at least one of the first 10 drugs identified for Medicare price negotiations, according to a new KFF analysis. Medicare is expected to release the negotiated drug prices, which will go into effect in 2026, by no later than September 1, 2024.
    • “The most used drug for people with employer-sponsored health insurance was Jardiance, a drug used to treat diabetes and heart failure, which was taken by more than 911,000 enrollees.
    • In the future, the Medicare program will negotiate prices for additional drugs, which millions more people with employer coverage could also be taking. As the policy currently stands, lowering drug prices in Medicare has no direct effect on private insurance plans, and the indirect effects are still unclear. Some argue lower negotiated prices in Medicare will result in higher prices in private insurance plans, while others suggest Medicare prices could serve as a benchmark and lead to savings.
    • “The full analysis and other data on health costs are available on the Peterson-KFF Health System Tracker, an online information hub dedicated to monitoring and assessing the performance of the U.S. health system.”
  • Per HHS press releases,
    • “This week, the Africa Centres for Disease Control and Prevention (Africa CDC) declared the mpox clade I outbreak a Public Health Emergency of Continental Security, and the World Health Organization (WHO) declared this outbreak a Public Health Emergency of International Concern. The United States government supports those declarations. The United States will continue to work closely with African governments, Africa CDC and WHO to ensure an effective response to the current outbreak and to protect the health and lives of people of the region.” * * *
    • “The risk to the general public in the United States from clade I mpox circulating in the DRC is very low, and there are no known cases in the United States at this time. Due to efforts over the last nine months, the United States is well prepared to rapidly detect, contain, and manage clade I cases should they be identified domestically. The United States has a robust surveillance system in place, including through clinical testing and wastewater analysis. We continue to encourage those at high risk to get vaccinated with the JYNNEOS mpox vaccine, which has been demonstrated to be safe and highly effective at preventing severe disease from mpox. Those who have already had clade II mpox or are fully vaccinated against mpox are expected to be protected against severe illness from clade I mpox.
    • “CDC has issued an updated Health Alert Network advisory urging clinicians to consider clade I mpox in people who have been in DRC or neighboring countries in the previous 21 days; clinicians are also asked to submit specimens for clade-specific testing for these patients if they have symptoms consistent with mpox. Given the geographic spread of clade I mpox, the U.S. CDC issued an updated Travel Health Notice on Aug. 7, 2024, recommending travelers to DRC and neighboring countries practice enhanced precautions.”
  • and
    • “The federal interagency National Integrated Heat Health Information System (NIHHIS) today released a National Heat Strategy for 2024-2030. The strategy aims to promote proactive coordination related to heat planning, response, and resilience. * * *
    • “For more information on the National Heat Strategy, please click here – PDF. To learn more about HHS’ climate change-related efforts, please visit HHS’ Office of Climate Change and Health Equity. To find more information about the federal government’s heat-related initiatives and resources, please visit heat.gov.”
  • STAT News informs us,
    • “The Food and Drug Administration on Wednesday approved a new treatment for primary biliary cholangitis, an autoimmune liver disease mainly affecting women that causes decreased liver function, debilitating itching, and fatigue.
    • “The drug, called Livdelzi, will be sold by Gilead Sciences, following the $4.3 billion acquisition of CymaBay Therapeutics, its developer, earlier this year.
    • “Regulators cleared Livdelzi for patients with primary biliary cholangitis, or PBC, that doesn’t respond adequately to initial treatment with a commonly used medicine. Gilead estimates there are approximately 130,000 people in the U.S. who are impacted by PBC, of which about 30,000 to 40,000 don’t respond to first-line therapy.
    • “Competition will come primarily from two drugs: Ipsen’s Iqirvo, which won FDA approval in June; and an older medicine called Ocaliva, developed by Intercept Pharma and recently acquired by Alfasigma, an Italian pharmaceutical firm.
    • “There’s still a real need out there for patients with PBC today, despite all the new arrivals. We believe Livdelzi can make a real difference for these people,” said Gilead Chief Commercial Officer Johanna Mercier.”

From the public health and medical research front,

  • The American Hospital Association News lets us know,
    • “The Centers for Disease Control and Prevention Aug. 13 issued an advisory alerting of an uptick of cases of parvovirus B19 across the U.S. Parvovirus B19 is a seasonal respiratory virus spread by respiratory droplets through symptomatic or asymptomatic individuals. Many people are asymptomatic, but immunocompetent children and adults with symptomatic disease typically develop a biphasic illness, CDC said. The first phase lasts approximately five days and includes symptoms of fever, myalgia and malaise, which develop about a week after infection. During the second phase, children often develop a facial rash which may be followed by reticulated body rash or joint pain one to four days later. For immunocompetent adults, the most common symptoms of parvovirus B19 disease typically occur during the second phase and include a reticular rash on the trunk and joint pain. Parvovirus B19 infection could also lead to adverse health outcomes among people without pre-existing immunity who are pregnant, immunocompromised or have chronic hemolytic disorders.”
  • Here is a link to the National Cancer Institute’s latest cancer information highlights.
  • Per National Institutes of Health press releases,
    • “Two National Institutes of Health (NIH)-supported trials of an experimental malaria vaccine in healthy Malian adults found that all three tested regimens were safe. One of the trials enrolled 300 healthy women ages 18 to 38 years who anticipated becoming pregnant soon after immunization. That trial began with drug treatment to remove malaria parasites, followed by three injections spaced over a month of either saline placebo or the investigational vaccine at one of two dosages. Both dosages of the vaccine candidate conferred a significant degree of protection from parasite infection and clinical malaria that was sustained over a span of two years without the need for a booster dose—a first for any malaria vaccine. In an exploratory analysis of women who conceived during the study, the vaccine significantly protected them from malaria in pregnancy. If confirmed through additional clinical trials, the approach modeled in this study could open improved ways to prevent malaria in pregnancy.
    • “Spread by Anopheles mosquitoes, malaria parasites, including those of the species Plasmodium falciparum (Pf), can cause illness in people of any age. However, pregnant women, infants and very young children are especially vulnerable to life-threatening disease. Malarial parasitemia in pregnancy is estimated to cause up to 50,000 maternal deaths and 200,000 stillbirths in Africa each year.  
  • and
    • “National Institutes of Health (NIH) researchers discover that while artificial intelligence (AI) tools can make accurate diagnoses from textbook-like descriptions of genetic diseases, the tools are significantly less accurate when analyzing summaries written by patients about their own health. These findings, reported in the American Journal of Human Genetics, demonstrate the need to improve these AI tools before they can be applied in health care settings to help make diagnoses and answer patient question.” * * *
    • “For these models to be clinically useful in the future, we need more data, and those data need to reflect the diversity of patients,” said Dr. Ben Solomon [,the study’s senior author]. “Not only do we need to represent all known medical conditions, but also variation in age, race, gender, cultural background and so on, so that the data capture the diversity of patient experiences. Then these models can learn how different people may talk about their conditions.”
    • “Beyond demonstrating areas of improvement, this study highlights the current limitations of large language models and the continued need for human oversight when AI is applied in health care.
    • “These technologies are already rolling out in clinical settings,” Dr. Solomon added. “The biggest questions are no longer about whether clinicians will use AI, but where and how clinicians should use AI, and where should we not use AI to take the best possible care of our patients.”
  • The Washington Post reports,
    • For many, middle age is associated with midlife crises and internal tumult. According to new research, it is also when the human body undergoes two dramatic bouts of rapid physical transformation on a molecular level.
    • In a new study, scientists at Stanford University tracked age-related changes in over 135,000 types of molecules and microbes, sampled from over 100 adults. They discovered that shifts in their abundance — either increasing or decreasing in number — did not occur gradually over time, but clustered around two ages.
    • “Obviously you change throughout your entire life. But there are two major periods when there are lots of changes: One is when people hit their mid-40s, and one is they hit their 60s,” said Michael Snyder, a geneticist at Stanford University who co-wrote the study, in a phone interview. On average, the changes clustered around the ages of 44 and 60.” * * *
    • “The exact reason these molecular changes cluster at the mid-40s and 60s is unclear. But the study’s authors say their findings show that from your 40s, people stand to gain particular benefits from taking care of their health. This includes getting regular medical check ups — at least twice a year once you hit your 40s, Shen suggested — as well as making lifestyle adjustments.”
  • Reuters tells us,
    • “The U.S. Department of Agriculture said on Tuesday it will expand bird-flu testing of beef entering the food supply as part of its response to the ongoing outbreak among dairy cattle, adding that U.S. beef and dairy products remain safe to consume.
    • ‘USDA officials, in a call with reporters along with staff from other U.S. health agencies, said the tests will begin in mid-September and urged livestock workers to remain vigilant.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Elevance and its private equity partner have officially introduced their care delivery platform, called Mosaic Health, after teasing the joint venture earlier this spring.
    • “Mosaic is comprised of two of Clayton, Dubilier and Rice’s primary care portfolio companies — Apree Health and Millennium Physician Group — along with the care delivery and enablement assets of Elevance’s health services division Carelon.
    • “However, Mosaic is launching without Carelon’s advanced primary care platform, according to the announcement on Wednesday. Carelon’s assets will join Mosaic subject to ongoing regulatory approvals. An Elevance spokesperson did not respond to a request for comment on the timeline of approvals.”
  • Per MedTech Dive,
    • “Otsuka’s digital health subsidiary has launched its first product, an app-based treatment for major depressive disorder. 
    • “The app, called Rejoyn, is available only by prescription and is intended to be used in addition to medications. It consists of a six-week program with cognitive behavioral therapy-based video lessons and exercises for identifying emotions. Otsuka announced the launch on Tuesday.
    • “Sanket Shah, president of the Japanese pharmaceutical company’s new Otsuka Precision Health subsidiary, said the treatment was priced at $50 on a cash-pay basis, with the goal of making it accessible. “This is, to be honest, not going to make money,” Shah said in an interview. “We have to put the investment into this to build this out because we do believe in the [digital therapeutics] model and digital solutions and using technology to really help patients.” 
  • Per Fierce Healthcare,
    • “Startup Abridge has notched its largest partnership to date as Kaiser Permanente is making the company’s AI-powered medical note-taking app available to more than 24,000 doctors across its system.
    • “The integrated nonprofit is rolling out Abridge’s technology at 40 hospitals and more than 600 medical offices in eight states and Washington, D.C., the organization announced Wednesday. The health system’s clinical staff includes 24,600 physicians and 73,600 nurses.
    • “Kaiser Permanente’s venture arm also is one of Abridge’s investors. The company, founded in 2018, has raised $212.5 million to date, including a $150 million series C funding round in February.
    • “The health system has worked with Abridge over the past year to implement the AI-based medical documentation technology. Desiree Gandrup-Dupre, senior vice president of care delivery technology services at Kaiser Permanente, said it was the largest implementation to date of ambient listening technology.
    • “At Kaiser Permanente, we have a long history of successfully deploying proven technologies on a broad scale, as we continue to provide health care and services when, how, and where our patients need it,” Gandrup-Dupre said in a statement.
    • “The goal is to help doctors reduce time spent on administrative tasks, allowing them to be more present with patients during medical visits, Kaiser Permanente executives said.”
  • Morningstar points out,
    • “The Social Security cost-of-living adjustment for 2025 could shrink in 2025 from this year’s 3.2% increase as inflation cools. 
    • “COLA could be 2.6% in 2025, according to Mary Johnson, an independent Social Security and Medicare analyst and former analyst with the Senior Citizens League. The new forecast compares to her forecast in July that called for a 2.7% increase. 
    • “The 2.6% increase would be the lowest COLA since 2021, but average for the past 20 years, Johnson said.”

Tuesday Tidbits

David Ermer–Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • Per a Senate press release,
    • “U.S. Senator Sherrod Brown (D-OH) announced [on August 12, 2024] the introduction of legislation to make it easier for workers without 4-year college degrees, including veterans, to get federal jobs, and to promote hiring based on workers’ skills rather than the degree they attain.
    • “The Federal Jobs for STARs Act would make federal jobs more accessible for non-degree-holders by taking steps to reduce or remove unnecessary educational requirements and making it easier for Ohioans to search on USAJOBS.com for jobs that match their experience and skills.
  • Federal News Network lets us know,
    • “New instances of fraud in the government’s Flexible Spending Account program, FSAFEDS, are dwindling. But the investigation into the issue remains ongoing. In total, fraudulent activity in the Office of Personnel Management benefits program has now cost more than $1 million. OPM has been working with FSAFEDS vendor HealthEquity to secure impacted federal employee accounts and add security measures to the program. OPM’s inspector general office is also working with the FBI to look into the issue further. But OPM said there’s so far no evidence of the FSAFEDS systems being compromised.”
  • Per a CMS press release,
    • “CMS is encouraging pharmacies and other affected parties to prepare now for the expected transition of coverage from Medicare Part D to Medicare Part B for Preexposure Prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. We expect to release the final National Coverage Determination (NCD) in late September 2024. Coverage under Part B will begin once we release the final NCD.
    • “Do you have questions about pharmacy enrollment?  We’re going to answer your questions so you can prepare your pharmacy for Part B coverage of PrEP for HIV during Pharmacy Enrollment Office Hours on Thursday August 22 from 3:30-4:30 pm ET. 
    • “Register for this webinar. After you register, you’ll receive a confirmation email with information about joining the webinar.”
  • The American Hospital Association News informs us,
    • “The AHA Aug. 13 commented to the Medicare Payment Advisory Commission in anticipation of the commission’s 2024-2025 cycle. The AHA urged MedPAC to carefully consider the negative consequences for beneficiaries, providers and communities if Medicare payments to 340B hospitals are cut; reconsider its pursuit of inpatient rehabilitation facility-skilled nursing facility site-neutral payment policy; support updates to physician reimbursement that more adequately account for inflation; and recommend repealing in-person visit requirements for tele-behavioral health services.

From the public health and medical research front,

  • MedCity News tells us,
    • “There are more than 123 million people in the U.S. living with obesity, and this prevalence is largely due to a lack of access to care, environmental factors, stigma and inadequate coverage, according to a new report. Tackling these issues will take a “multifaceted approach,” the report states.
    • “The publication was released last week in the American Journal of Managed Care and was funded by the Diabetes Leadership Council, a nonprofit patient advocacy organization. The researchers conducted an internet search of relevant studies and government reports.
    • “Our goal is to ensure that people are getting the right treatment at the right time for them. And we understand that this looks differently for everybody … and not everyone fits the same mold,” said Erin Callahan, chief operating officer of Diabetes Leadership Council and Diabetes Patient Advocacy Coalition, in an interview. “So our goal is to ensure that people are well cared for and have equitable access to the things they need along any part of their medical journey.”
  • Cardiovascular Business notes,
    • “Over the past few decades, research has clearly shown that there are distinct characteristics of ischemic heart disease in women that are not seen in men. While women often need tailored diagnostic approaches for diagnosis and treatment, the one-size-fits-all approach using the male heart disease presentations as the standard of care has likely impacted female mortality in terms of cardiac deaths, which is the No. 1 killer in the world for both men and women.
    • “Emily Lau, MD, director of the Cardiometabolic Health and Hormones Clinic at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School, shed light on the critical issue of gender differences in chest pain imaging evaluations in sessions at the American College of Cardiology (ACC) 2024 meeting earlier this year. She spoke with Cardiovascular Business about her presentation.
    • “Women are more likely to present with non-obstructive coronary disease,” Lau explained. “This means they may not have significant blockages in their arteries, but they still experience symptoms of heart disease.”
  • Beckers Hospital Review points out,
    • “Adverse drug reactions [affecting the skin] are a known risk of antibiotic use, but it has been unclear which drug classes carry the highest risk — until now. 
    • “To crack at this mystery, researchers in Toronto analyzed two decades worth of data on hospitalizations and emergency department visits for serious skin reactions in older adults, according to a study published Aug. 8 in JAMA. They compared the results for each drug class to macrolides. 
    • “Among the 21,758 older adults, the antibiotics most strongly associated with serious skin conditions were sulfonamides, cephalosporins, nitrofurantoin, penicillins and fluoroquinolones. 
    • For the 2,852 hospitalized patients, the average length of stay was six days, 9.6% required transfer to a critical care unit and 5.3% died in the hospital. 
    • “When clinically appropriate, the researchers recommended prescribers use lower-risk antibiotics.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Kaiser Permanente reported a $2.1 billion net gain in the second quarter, representing a solid end to the nonprofit hospital and health plan’s financial performance in the first half of its fiscal year, according to an analyst.
    • “Kaiser’s operating margin rose to 3.1%, up from 2.9% the same time last year. The Oakland, California-based health system reported an operating income of $908 million as revenues grew at a faster clip than expenses.
    • “The second quarter marked the first time Geisinger Health’s financial performance was fully integrated into Kaiser’s earnings. While Kaiser did not break out Geisinger’s results, one analyst estimated the system contributed up to $2 billion in revenue during the quarter.”
  • and
    • “Orthopedics device company Stryker said Monday it has reached an agreement to acquire Care.ai, a company that offers artificial intelligence-based tools for hospitals. The Orlando, Florida-based startup makes patient monitoring, virtual rounding and AI-assisted decision support tools based on a network of sensors. 
    • “Stryker did not immediately respond to questions about the price or timing of the acquisition.
    • “The acquisition comes about two weeks after Stryker CEO Kevin Lobo forecast a “very active deal pipeline” for the second half of the year.”
  • Per Fierce Healthcare,
    • “Steward Health Care has agreed to sell its physicians network, Stewardship Health, to Rural Healthcare Group, which is owned by a private equity group.
    • “The embattled health system signed a definitive agreement to sell Stewardship, one of the largest primary care provider organizations in the country, for a proposed purchase price of $245 million, according to court documents filed in federal bankruptcy court Aug. 12. The court documents (document 1953 and 1954) can be found on an online portal set up for court filings and other restructuring information about Steward Health Care.
    • “RHG, an affiliate of PE firm Kinderhook Industries, will buy Stewardship through Brady Health Buyer, a company set up by Kinderhook to complete the transaction, according to court documents.
    • “Kinderhook offered $245 million in cash for Stewardship, according to court documents.
    • “The sale is subject to bankruptcy court and regulatory approval.”
  • Per BioPharma Dive,
    • “Galderma on Tuesday said the Food and Drug Administration has approved its antibody drug Nemluvio for adults with prurigo nodularis, a chronic skin condition characterized by intense itch.
    • “A subcutaneous injection, Nemluvio works by blocking cellular signaling via a cytokine called IL-31. Results from two Phase 3 clinical trials showed treatment helped to reduce itch intensity, clear skin and improve sleep, compared to a placebo.
    • “In an email, Galderma declined to disclose the price it plans to charge for Nemluvio. The company said the drug will be available in the coming weeks.” 
  • Per MedTech Dive,
    • “Medtronic said Monday it received Food and Drug Administration approval for deep brain stimulation (DBS) technology that is implanted while the patient is under general anesthetic.
    • “Surgeons traditionally perform DBS procedures, a treatment for medical conditions like epilepsy and Parkinson’s disease, while the patient is awake. However, a series of studies have shown there may be benefits to putting the patient to sleep for the procedure.
    • “Medtronic said it is the first company to receive FDA approval to offer DBS surgery while a patient is asleep or awake. U.S. surgeons have used DBS devices off-label in asleep patients for years.”
  • and
    • “Baxter has agreed to sell its Vantive kidney care business to private equity firm Carlyle Group for $3.8 billion, the companies said Tuesday. Carlyle is partnering with Atmas Health in the investment. 
    • “Carlyle formed Atmas Health in 2022 with healthcare executives Kieran Gallahue, Jim Hinrichs and Jim Prutow to focus on acquiring assets in the medical technology, life science tools and diagnostics sectors. Gallahue will become chairman of Vantive, working with Vantive CEO Chris Toth.
    • “Baxter will target annual operational sales growth of 4% to 5% after the Vantive transaction is complete.”
  • Per Stat News,
    • “The unwinding of Illumina’s ill-fated acquisition of Grail earlier this year left investors and the genomics community with a pressing question: What kind of company is Illumina going to be going forward?
    • “CEO Jacob Thaysen on Tuesday made clear that the sequencing firm, which controls about 80% of the current DNA-sequencer market, is essentially returning to its traditional role of creating instruments for researchers in academia, the biopharma industry, and health care settings.”
  • The Wall Street Journal examines the state of the hospital at home business. “Institutions say it is safe and opens hospital beds, but policymakers fear it’s too pricey and lacks strict standards.”
  • Risk & Insurance alerts us that “Employers are expanding comprehensive wellbeing programs to meet employee needs, while adopting varied cost management strategies amid rising health and drug costs, a Gallagher benchmarking report finds. * * * View the complete benchmark report, including breakouts by region and employer size, on Gallagher’s website.” 

Monday Roundup

David Ermer–CDC, Congress, COVID-19, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Govexec reports,
    • “A new initiative from the Biden administration aims to quell a varied series of consumer “headaches” by reducing their extraneous time and processes, including for federal employees trying to file health insurance claims.
    • “Detailed in a memo Monday, the “Time Is Money” initiative would touch upon processes across multiple industries that the White House deemed deliberate, time-consuming and burdensome for consumers, such as procuring refunds, canceling subscriptions and filing insurance claims.”  * * *
    • “The memo also outlined plans by the Office of Personnel Management to make it easier for employees on the Federal Employees Health Benefits and Postal Service Health Benefits plans to submit out-of-network claims online, would provide them with better information about which providers are in-network and how to appeal claim denials. 
    • “The proposed OPM requirements are part of a larger proposal within the initiative that would focus on streamlining the insurance claims process, with the Labor and Health and Human Services secretaries calling on insurance carriers to simplify their claims process and move it online, while also improving information access and call center times.” * * *
    • OPM officials were unable to respond by press time to questions about how and when the requirements will be rolled out. 
  • The FEHBlog doubts that many people submit health insurance claims. Dental claims may be a different story.
  • Here’s a link to an HHS and Labor Secretary message to health insurer CEOs about the new initiative.
  • Federal News Network points out six federal workforce bills pending in Congress that are worth tracking.

From the public health and medical research front,

  • STAT News lets us know,
    • “The Centers for Disease Control and Prevention issued a new risk assessment of the H5N1 bird flu virus circulating in dairy cows on Friday, increasing slightly its estimate of the chance it poses of triggering a pandemic.
    • “The new assessment, developed using the CDC’s influenza risk assessment tool or IRAT, gauged the risk the virus might someday cause a pandemic at 5.79, up from a previous score of 5.12 from an assessment of a related virus conducted in April 2023. Both numbers are within what the CDC tool terms a “moderate” risk of 4.0 to 7.9. Some swine influenza viruses and the H7N9 bird flu virus have scored higher than this version of H5N1 using the IRAT process.” * * *
    • “Vivien Dugan, director of the CDC’s influenza division, cautioned that the IRAT is a tool for government planning purposes, and isn’t meant to gauge the risk for the public. The agency still characterizes the risk H5N1 poses to the general public as low.”
  • Per an NIH press release,
    • “A National Institutes of Health (NIH)-supported study has found that routine lab tests may not be useful in making a long COVID diagnosis for people who have symptoms of the condition. The study, part of NIH’s Researching COVID to Enhance Recovery (NIH RECOVER) Initiative and published in the Annals of Internal Medicine, highlights how challenging it can be to identify and diagnose a novel illness such as long COVID.” * * *
    • “Future work will use RECOVER’s biobank of cohort samples such as blood and spinal fluid, to develop more novel laboratory-based tests that help us better understand the pathophysiology of long COVID,” said Kristine Erlandson, M.D., professor of medicine-infectious disease at the University of Colorado Anschutz Medical Campus, Aurora.”
  • BioPharma Dive tells us,
    • “Pfizer on Monday said its RSV vaccine Abrysvo led to strong immune responses in immunocompromised adults given the shot in a late-stage study.
    • “The results came from a sub-study of a Pfizer-run Phase 3 trial testing two doses of Abrysvo in adults at risk of severe lower respiratory tract disease associated with respiratory syncytial virus, or RSV. Vaccination was well-tolerated, Pfizer said, and led to a “strong neutralizing response” against RSV subtypes A and B.
    • “The data add to evidence of the effectiveness of Abrysvo, which faces competition from GSK’s rival vaccine Arexvy and Moderna’s mResvia, which gained Food and Drug Administration approval in May.”
  • Beckers Hospital Review informs us,
    • “Labels for GLP-1 medications, like Ozempic and Mounjaro, might see more approved uses as researchers study the drugs’ effects on sleep apnea, dementia and other health issues. Meanwhile, oncologists are looking at a GLP-1 role in cancer care.
    • “Several studies have shown the therapies — currently approved for Type 2 diabetes and weight loss — can diminish the risk of multiple cancers:
      • “Compared with Type 2 diabetes patients taking insulin, those who took the medications were less likely to develop 10 of 13 obesity-related cancers, one study found. 
      • “In another study of Type 2 diabetes patients, GLP-1 users saw a decreased risk of colorectal cancer than those who took insulin, metformin, SGLT2 inhibitors, sulfonylureas and thiazolidinediones. 
      • “Both bariatric surgery and GLP-1 use reduced the risk of obesity-related cancers in a retrospective analysis, according to data presented at the American Society of Clinical Oncologists meeting in June. Post-surgery, the risk declined 22%; with GLP-1s, the risk fell 39%. 
    • “The results are promising, but oncologists will need to see more research before they change their practices.”
  • Per Health Day,
    • “Folks can overcome their genetic risk for type 2 diabetes through healthy diet and regular exercise, a new study says.
    • “A healthy lifestyle reduced the risk of type 2 diabetes by 70% among a group of people with a high genetic likelihood of developing the metabolic disorder, researchers found.
    • “In fact, healthy behaviors had a greater impact on their risk than it did for people with a low genetic propensity for type 2 diabetes, results showed. A healthy diet and exercise had a statistically insignificant impact on the diabetes risk of those with low-risk genetics, researchers found.
    • “Nevertheless, “these findings encourage everyone to make lifestyle changes that promote health,” said lead researcher Maria Lankinen, a lecturer in nutrition with the University of Eastern Finland.
    • “That’s because all participants tended to achieve better blood sugar control and lost weight if they engaged in a healthy lifestyle, researchers said.”
  • The Wall Street Journal notes,
    • “Multiple servings of milk, cheese or yogurt have long been a staple of American nutrition advice. Now a growing number of researchers and doctors say you need less dairy than you think, and maybe even none at all.
    • “The U.S. government, which recommends that adults eat three servings of dairy a day, is taking a fresh look at its guidance. A committee of scientific advisers is analyzing diets with lower amounts of dairy to study what happens to people’s nutrient levels. That is the first step toward possibly changing the recommendation in the next update of the country’s dietary guidelines. Other countries already recommend less dairy than the U.S. does.
    • “The problem? Dairy-rich diets have been linked to increased risks of cardiovascular diseaseand certain cancers in some studies. Foods like ice cream, full-fat cheese and pizza are high in calories and saturated fat. 
    • “However, the research isn’t clear-cut. Some studies link dairy foods to a lower risk of heart disease, some cancers and Type 2 diabetes. When it comes to milk, scientists can’t agree on whether full fat or skim is better. 
    • “Long story short: Go ahead and enjoy your Greek yogurt and that mozzarella in your caprese salad. Just don’t have too much; some experts say one serving a day—one cup of yogurt or 1.5 ounces of the cheese—is good.” 
  • The New York Times warns us,
    • “Even light drinking was associated with an increase in cancer deaths among older adults in Britain, researchers reported on Monday in a large study. But the risk was accentuated primarily in those who had existing health problems or who lived in low-income areas.
    • “The study, which tracked 135,103 adults aged 60 and older for 12 years, also punctures the long-held belief that light or moderate alcohol consumption is good for the heart.
    • “The researchers found no reduction in heart disease deaths among light or moderate drinkers, regardless of this health or socioeconomic status, when compared with occasional drinkers.
    • “The study defined light drinking as a mean alcohol intake of up to 20 grams a day for men and up to 10 grams daily for women. (In the United States, a standard drink is 14 grams of alcohol.)
    • “We did not find evidence of a beneficial association between low drinking and mortality,” said Dr. Rosario Ortolá, an assistant professor of preventive medicine and public health at Universidad Autónoma de Madrid and the lead author of the paper, which was published in JAMA Network Open.
    • “On the other hand, she added, alcohol probably raises the risk of cancer “from the first drop.”

From the U.S. healthcare business front,

  • Healthcare Dive tells us,
    • “U.S. nonprofit hospitals and health systems’ median days of cash on hand hit a 10-year low in 2023, falling below 200 days for the first time in a decade, according to a report from S&P Global Ratings.
    • “Cash flow did not meaningfully improve from 2022 to 2023, the report said. However, operating expenses grew only modestly at 5%, following a steep 17% growth rate in 2022.
    • “While the sector is making incremental progress toward financial recovery, performance metrics are still below providers’ financial targets. The authors also noted a growing gap between the sector’s top performers and weaker providers.”
  • The American Journal of Managed Care examines “Hospitals’ Strategies to Reduce Costs and Improve Quality: Survey of Hospital Leaders.”
    • “Takeaway Points
    • “A decade after the implementation of value-based payment models, little is known about the strategies hospitals currently use to improve outcomes and reduce costs.
    • “On average, across 20 strategies in 4 domains—inpatient, post-acute, outpatient, and community resources for vulnerable patients—hospitals reported having implemented between 65% and 89% of the strategies queried.
    • “A higher proportion of hospitals participating in bundled payments implemented interventions aimed at reducing post-acute care compared with other hospitals (78.3% vs 37.6%; P < .0001), but patterns were otherwise similar.
  • Beckers Hospital Review looks into why Kaiser Permanente is having success with its retail clinics located inside Target stores in southern California.
  • Beckers Payer Issues explores UnitedHealthcare’s approach to consumerism in 2024.
  • Fierce Healthcare reports,
    • While customer satisfaction with mail order pharmacies is continuing to grow, brick-and-mortar pharmacies are falling behind, according to a new survey from J.D. Power.
    • The firm’s annual Pharmacy Survey found that retail pharmacies saw overall satisfaction scores decrease by more than 10 points, while scores for mail order pharmacies grew by six. The survey found that consumers visiting brick-and-mortal facilities are facing long-wait times and issues in ordering prescriptions, which is worsening the experience.
    • What brick-and-mortar pharmacies do best is communicate clearly with consumers, according to the survey, with 89% of customers indicating that messages from the pharmacist were offered clearly and understood.
    • However, there’s a trust gap. Only 51% said they view their pharmacist as trustworthy, and the same percentage said prescriptions were filled quickly.
    • Building that trust is critical to improving the consumer experience, Christopher Lis, managing director of global healthcare intelligence at J.D. Power, told Fierce Healthcare in an email interview.
    • [T]here is room for improvement for mail order pharmacies as well, the study found. While the key factor consumers enjoy is the convenience of ordering prescriptions, just 18% of consumers said that their pharmacy has a well-designed digital experience.
  • Per Fierce Pharma,
    • “Ascendis Pharma should be well prepared for the U.S. launch of its hormone replacement therapy for hypoparathyroidism, which was approved on Friday by the FDA.
    • “After all, the company was initially set to bring the drug to the market 15 months ago before the FDA rejected it with a surprise complete response letter (CRL). Then three months ago, Ascendis again was ready to roll before the U.S. regulator said it needed an additional three months to make its decision.
    • “Finally, Copenhagen-based Ascendis is now good to go with once-daily Yorvipath (palopegteriparatide), also known as TransCon PTH, which is the first FDA-approved product for hypoparathyroidism in adults.
    • Ascendis expects the initial supply to be available in the first quarter of next year with the potential to move the launch up to the fourth quarter this year, as the company has requested FDA approval to commercialize doses it has already made.
  • and
    • “With Gilead Sciences’ stated focus to grow in oncology, the company’s recent quarterly updates have placed a heavy emphasis on its developments in the cancer space. But, with a unique pre-exposure prophylaxis (PrEP) offering for HIV that could “redefine” the market, the drugmaker is touting lofty ambitions there, too.
    • “After scoring an FDA approval for Sunlenca (lenacapavir) to treat multidrug-resistant HIV, Gilead launched the drug at end of 2022. The drug’s every-six-month dosing schedule has yet to show its full potential given that it must still be paired with other daily drugs to form a complete regimen. The indication isn’t exactly a major sales driver, as Sunlenca’s approved patient population represents just 2% of adults with HIV.
    • “That approval was just “the beginning of the rest of this journey,” Gilead’s vice president of clinical development Jared Baeten, M.D., Ph.D., said in an interview at the time. Now, the company is looking to another milestone late next year with the planned commercial launch of Sunlenca as a long-acting PrEP med, CEO Daniel O’Day said on Gilead’s second-quarter earnings call.” 

Weekend Update

David Ermer–CDC, Congress, COVID-19, Medical / Rx research, OPM–

From Washington, DC,

  • The House of Representatives and the Senate are on District / State work breaks until September 9.
  • Federal News Network reports,
    • “After more than a year of pressure building in Congress, lawmakers now have more answers on federal telework levels, return-to-office policies and office space plans from the White House.
    • “In a report the Office of Management and Budget sent to Congress Friday afternoon, shared with Federal News Network, the Biden administration released details on agencies’ varying policies and approaches to where and how federal employees work, as well as federal real estate holdings and plans to improve office space utilization.
    • “While noting that more than half of the federal workforce is not able to telework at all, OMB reported that agencies are on average exceeding the administration’s 50% in-the-office goal for telework-eligible feds. Governmentwide, roughly 61% of the work hours that telework-eligible federal employees performed have been in person, according to time and attendance data OMB collected from the 24 CFO Act agencies during two pay periods in May.
    • “Also based on agencies’ time and attendance data, OMB reported that out of about 2.2 million federal employees:
    • “About 54% of federal employees worked fully in person due to the nature of their work
    • “About 46% of federal employees were eligible for telework
    • “About 10% of federal employees worked fully remotely.

From the public health and medical research front,

  • Per NPR Shots,
    • “Four years after SARS-CoV2 sparked a devastating global pandemic, U.S. health officials now consider COVID-19 an endemic disease.
    • “At this point, COVID-19 can be described as endemic throughout the world,” Aron Hall, the deputy director for science at the CDC’s coronavirus and other respiratory viruses division, told NPR in an interview.
    • “That means, essentially, that COVID is here to stay in predictable ways. 
    • “The classification doesn’t change any official recommendations or guidelines for how people should respond to the virus. But the categorization does acknowledge that the SARS-CoV2 virus that causes COVID will continue to circulate and cause illness indefinitely, underscoring the importance of people getting vaccinated and taking other steps to reduce their risk for the foreseeable future.” * * *
    • “We’re going to have to continue to live with COVID,” says Caitlin Rivers, an epidemiologist at the Johns Hopkins Center for Health Security. “It’s one more thing people have to deal with. It’s another reason your kids might miss school, or you might miss work or another thing to think about when planning gatherings. We’re stuck with it.”
  • The Washington Post lets us know,
    • “Mammogram callbacks are common — about 10 out of every 100 womenare told they need more imaging after an initial screening, according to the American College of Radiology — but can be scary, especially if you have to wait for an appointment. The vast majority of the callbacks, however, turn out to be false alarms, according to the American Cancer Society. Fewer than 1 in 10 women who return for more imaging have cancer.
    • “Women should never ignore a callback, which usually involves more extensive pictures, known as a diagnostic mammogram, and sometimes will require a sonogram and biopsy, experts say. Early detection of breast cancer usually means less-invasive treatment and high survival, more than 90 percent five years out, experts say.
    • “Callbacks happen frequently and with good reason, because we want to be sure,” says Karen E. Knudsen, chief executive officer of the American Cancer Society. “Most of the time, nothing is wrong. But if you get a callback, make the appointment.”
  • and
    • “Women who have not been very physically active over the years were 40 percent more likely to experience a fall when they reached their 70s, according to new research published in the British Journal of Sports Medicine.
    • “The study involved over 11,700 participants (with an average age of 54) in the Australian Longitudinal Study on Women’s Health, which has been following the health of over 57,000 Australian women in four different age cohorts.
    • “For this study, which lasted 18 years, women born from 1946 to 1951 reported every three years how much exercise they had been getting. That level of weekly physical activity participation was based on the total of three types of exercise: walking briskly and moderate and vigorous leisure activity. When participants were age 68 to 73, they were also asked about falls and related injuries they had experienced.”
  • Fortune Well offers tips on how to improve your chances of becoming a SuperAger.
    • “Some people have won the longevity lottery—they are among the lucky few known as SuperAgers. 
    • “In a relatively new field, researchers are examining what contributes to people in their 80s and 90s having stronger brain power than their peers. Many are wondering if those findings can be distilled into a longevity routine or pill to help everyone become a SuperAger. Is it possible to increase your odds of becoming a SuperAger? 
    • “It’s not inevitable that we will become disabled and sick as we get older. What we’re learning from these unique individuals is that it is biologically plausible for us to live long and healthy,” says Dr. Sofiya Milman, the director of the Human Longevity Studies at Einstein’s Institute for Aging Research and the lead investigator of the SuperAgers Family Study, which has enrolled 550 SuperAgers since 2022. “Once we know what causes longevity, that it’s not a disease, we can then create therapies that will promote that biological longevity, and ultimately, that’s the goal of what we’re doing.” 

From the U.S. healthcare business front,

  • Per HR Dive,
    • “Employers may continue to use the most recent Form I-9 until May 31, 2027, U.S. Citizenship and Immigration Services said last week, extending the document’s expiration date.
    • “HR professionals must ensure they’re using the form with an Aug. 1, 2023, edition date, according to the agency. Newly downloaded forms will bear the new expiration date but employers may — for now — continue using any previously downloaded or printed forms bearing the previous July 31, 2026, expiration date. 
    • “Either form may be used until its respective expiration date,” USCIS said in a statement. However, “[e]mployers are encouraged to update their electronic Forms I-9 systems to use the [2027] expiration date as soon as possible and must do so no later than July 31, 2026,” it said.
  • Per Legal Dive,
    • “States and local governments should prohibit employers from using non-disclosure and non-disparagement agreements to keep employees from speaking out about sexual and other types of harassment, the American Bar Association says.
    • “NDAs … have effectively resulted in silencing people who experience sexual assault, sexual harassment, and other forms of harassment and discrimination in the workplace, preventing accountability for those who commit these harms and allowing the behavior to persist,” the ABA says.” * * *
    • “The resolution comes at a time when employers could be turning to NDAs even more if a nationwide ban on noncompete agreements takes effect this fall. The Federal Trade Commission passed the ban, but it faces court challenges, one of which has resulted in a partial stay. 
    • “Should the ban take effect, employers are likely to lean more heavily on other types of agreements, like non-disparagement agreements and other types of NDAs, to protect their interests from employees who leave to work for a competitor or to start a competing business.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the CrowdStrike outage front,

  • Dark Reading reports,
    • The CrowdStrike update that hobbled businesses, disrupted consumer travel plans, and took French and British broadcasters offline has predictably led to a host of lawsuits filed by investors and customers of both CrowdStrike and other affected companies.
    • Yet the incident could lead to another destination: software liability.
    • The overall consensus among legal experts is that CrowdStrike is likely protected by its terms and conditions from reimbursing customers for more than they paid for the product, limiting its software liability in what the company now refers to as “the Channel File 291 Incident.” However, the fact that affected businesses and consumers have little recourse to recover damages will likely lend momentum to legislation and state regulations to hold firms responsible for such chaos, says Chinmayi Sharma, associate professor of law at Fordham University.
  • Cybersecurity Dive lets us know,
    • “A mismatched software update in CrowdStrike’s Falcon sensor led to the crash that caused a global IT outage of millions of Microsoft Windows systems on July 19, the company said Tuesday. 
    • “CrowdStrike, in a root cause analysis report, said the Falcon sensor expected 20 input fields in a rapid response content update, but the software update actually provided 21 input fields. The mismatch resulted in an out-of-bounds memory read, leading to the system crash. 
    • “We are using lessons learned from this incident to better serve our customers,” CrowdStrike CEO George Kurtz said in a statement Tuesday. “To this end, we have already taken decisive steps to prevent this situation from repeating, and to help ensure that we – and you – become even more resilient.”
  • and
    • “CrowdStrike is in talks to acquire Action1, a Houston-based patch management and vulnerability specialist. The agreement being discussed would value the company at nearly $1 billion, according to a memo sent to Action1 employees. 
    • “Action1 Co-Founder and CEO Alex Vovk sent a memo to employees Wednesday confirming the discussions, after speculation around the talks gained within the company. A spokesperson for Action1 confirmed the authenticity of the memo to Cybersecurity Dive Friday. 
    • “This proves that Action1 is in a rapidly growing market and explains why Action1 is experiencing hypergrowth and is on track to soon reach $100M AAR,” Vovk wrote in the memo.” 

From the cybersecurity policy front,

  • Per Cybersecurity Dive,
    • “For Cybersecurity and Infrastructure Security Agency Director Jen Easterly the doomed CrowdStrike software update that took global IT systems and networks offline last month holds a “big lesson” for critical infrastructure.
    • “The CrowdStrike incident was such a terrible incident,” Easterly said Wednesday during a media briefing at Black Hat, but “it was a useful exercise, like a dress rehearsal for what China may want to do to us.”
    • “The outage was not the result of a malicious act, but rather a basic field input error that caused an out-of-bounds memory read. Yet, to Easterly, the widespread chaos it caused offers a clear example of what could occur if China-affiliated attackers make good on its efforts to cause systemic disruption to U.S. critical infrastructure.
    • “When Easterly learned of the outage, around 2 a.m. on July 19: “What was going through my mind was ‘oh, this is exactly what China wants to do.’”
  • Per Cyberscoop,
    • “Jen Easterly, the head of the Cybersecurity and Infrastructure Security Agency, told attendees at the Black Hat security conference on Thursday that delivering major improvements in computer security will require a sea change in how companies approach building software. 
    • “Amid an epidemic of breaches, Easterly laid the blame squarely at the feet of the technology industry. “We don’t have a cybersecurity problem. We have a software quality problem,” she said. 
    • “We have a multi-billion dollar cybersecurity industry because for decades, technology vendors have been allowed to create defective, insecure, flawed software,” Easterly said in her remarks.
    • “To address that issue, Easterly and CISA have launched a secure by design pledge, the signatories of which commit to a series of principles to improve the security of how products are developed and deployed. Easterly said 200 companies have now signed that pledge since its launch in March.”   
  • To that end, this week, CISA and the FBI posted their “Secure by Demand Guide: How Software Customers Can Drive a Secure Technology Ecosystem.” Here’s a link to the federal government’s Internet Complaint Center supplement guidance on this effort.
  • Cyberscoop also tells us,
    • “A year after asking the hacker community how they can better help protect the open source software that is the foundation of the digital economy, the White House is looking to better secure the ecosystem through a new office dedicated to study such components in critical infrastructure.
    • “The Office of the National Cyber Director released new details Friday on several projects aimed at securing open source software. The report comes a year after the office asked attendees at DEF CON in 2023 to contribute to a request for information around how to better focus on securing open source software.
    • “The new office runs out of the Department of Homeland Security and will examine the prevalence of open source software present in critical infrastructure and how to secure it, said Nasreen Djouini, senior policy advisor at the Office of the National Cyber Director. The program will have the support of the Department of Energy’s national labs, including at Los Alamos and Lawrence Livermore.”

From the cybersecurity vulnerabilities and breaches front,

  • Again, per Cyberscoop,
    • “An Israeli cybersecurity firm has identified a zero-day vulnerability affecting major web browsers that could allow attackers to bypass normal browser security measures and potentially breach local networks.
    • “The flaw, discovered by Oligo Security, was found in how browsers handle network requests. 
    • “In summary, devices read IP addresses to connect users to websites, with 0.0.0.0 serving as a placeholder until a real address is assigned. Oligo researchers found that a would-be attack can exploit how browsers like Apple’s Safari, Google’s Chrome and Mozilla’s Firefox handle queries to 0.0.0.0, redirecting them to other addresses such as ‘localhost,’ which is typically private. 
    • “This exploit allows attackers to access private data by sending requests to 0.0.0.0. Attackers could then perform all types of nefarious actions, gaining unauthorized access and executing remote code on locally running programs, which could impact development platforms, operating systems and internal networks.
    • Oligo has dubbed the vulnerability “0.0.0.0 day,” and wrote in a blog post that it considers it to be “far-reaching, affecting individuals and organizations alike.”
  • Here are the known exploited vulnerabilities that CISA added to its catalog this week,
  • Security Week points out,
    • The US cybersecurity agency CISA on Thursday informed organizations about threat actors targeting improperly configured Cisco devices.
    • The agency has observed malicious hackers acquiring system configuration files by abusing available protocols or software, such as the legacy Cisco Smart Install (SMI) feature. 
    • This feature has been abused for years to take control of Cisco switches and this is not the first warning issued by the US government. 

From the ransomware front,

  • Per a CISA press release,
    •  “CISA—in partnership with the Federal Bureau of Investigation (FBI)—released an update to joint Cybersecurity Advisory #StopRansomware: Royal Ransomware, #StopRansomware: BlackSuit (Royal) Ransomware. The updated advisory provides network defenders with recent and historically observed tactics, techniques, and procedures (TTPs) and indicators of compromise (IOCs) associated with BlackSuit and legacy Royal activity. FBI investigations identified these TTPs and IOCs as recently as July 2024.
    • “BlackSuit ransomware attacks have spread across numerous critical infrastructure sectors including, but not limited to, commercial facilities, healthcare and public health, government facilities, and critical manufacturing.
    • “CISA encourages network defenders to review the updated advisory and apply the recommended mitigations. See #StopRansomware for additional guidance on ransomware protection, detection, and response. Visit CISA’s Cross-Sector Cybersecurity Performance Goals for more information on the CPGs, including additional recommended baseline protections.”
  • Per Bleeping Computer,
    • ‘​On Tuesday (August 6], IT and phone systems at McLaren Health Care hospitals were disrupted following an attack linked to the INC Ransom ransomware operation.
    • “McLaren is a non-profit healthcare system with annual revenues of over $6.5 billion, which operates a network of 13 hospitals across Michigan supported by a team of 640 physicians. It also has over 28,000 employees and works with 113,000 network providers throughout Michigan, Indiana, and Ohio.
    • “While McLaren Health Care continues to investigate a disruption to our information technology system, we want to ensure our teams are as prepared as possible to care for patients when they arrive,” a statement on the health system’s website reads.”

From the cybersecurity defenses front,

  • Dark Reading writes about how
    • “Enterprises are implementing Microsoft’s Copilot AI-based chatbots at a rapid pace, hoping to transform how employees gather data and organize their time and work. But at the same time, Copilot is also an ideal tool for threat actors.
    • “Security researcher Michael Bargury, a former senior security architect in Microsoft’s Azure Security CTO office and now co-founder and chief technology officer of Zenity, says attackers can use Copilot to search for data, exfiltrate it without producing logs, and socially engineer victims to phishing sites even if they don’t open emails or click on links.
    • The article explains how to avoid such attacks.

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration turned down an ecstasy-based drug.
    • “The agency rejected use of the drug, known as MDMA, along with mental-health therapy in the treatment of post-traumatic stress disorder.  It asked Lykos Therapeutics, which had sought the approval, to test the drug therapy further, the company said Friday.
    • “The decision is a setback for decades of efforts to legalize psychedelics and a disappointment for veterans advocates and other groups that have been seeking a new, better medicine for treating the 13 million Americans with post-traumatic stress.
    • “Yet it isn’t a surprise, after FDA staff and expert advisers raised questions about the studies evaluating whether the MDMA drug from Lykos Therapeutics worked safely.
    • “Lykos said the FDA told the company it couldn’t approve the drug therapy based on the data submitted to date. The company said it would ask the FDA to reconsider its decision, as well as to discuss the agency’s recommendations for submitting another application.”
  • The Washington Post adds,
    • “The Food and Drug Administration on Friday approved a nasal spray for serious allergic reactions to food, medications and insect stings, marking the first needle-free treatment for such conditions.
    • “The epinephrine nasal spray is administered as a single dose in one nostril and will serve as a critical alternative to treating emergency allergic reactions without an injection, the agency said.
    • “The two-milligram spray, called Neffy, is designed to block allergic reactions, including a serious condition called anaphylaxis, which can happen within seconds or minutes of being exposed to an allergen.
    • “The decision introduces an alternative to auto-injector devices such as the EpiPen for blocking severe allergic reactions. It also vindicates the approach of Neffy manufacturer ARS Pharmaceuticals, which pitched its product as a superior way of treating anaphylaxis that overcomes people’s hesitation to inject themselves or someone else. Anaphylaxis can cause constriction of the airway.”

From the public health and medical research front,

  • The Centers for Disease Control tells us,
    • “Summary
      • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity has increased in most areas.
    • “COVID-19
      • “Most areas of the country are experiencing consistent increases in COVID-19 activity, with substantial increases in the southern United States. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
  • The University of Minnesota’s CIDRAP adds,
    • Wastewater detections continue to rise steadily and are now at the very high level. Levels continue to trend upward in all US regions and are highest in the West, followed by the South and Midwest. Test positivity for COVID is still rising and is at 17.6% nationally, up 1.2% compared to the previous week. Test positivity is highest in the region that includes Texas and surrounding states. 
  • and
    • “Among US children born in the past 30 years, childhood vaccines have prevented an estimated 508 million cases of illness, 32 million hospitalizations, and 1.1 million deaths, resulting in direct savings of $540 billion and societal savings of $2.7 trillion, according to a study yesterday in Morbidity and Mortality Weekly Report.
    • “Researchers from the Centers for Disease Control and Prevention (CDC) analyzed data since 1994, when the US Vaccines for Children (VFC) program was launched to cover the cost of vaccines for children whose families might not be able to afford them. They assessed the impact of routine childhood immunizations among both VFC-eligible and non–VFC-eligible children born from 1994 to 2023 for nine vaccines: diphtheria and tetanus toxoids and acellular pertussis vaccine; Haemophilus influenzae type b conjugate vaccine; poliovirus vaccines; measles, mumps, and rubella vaccine; hepatitis B vaccine; varicella vaccine; pneumococcal conjugate vaccine; hepatitis A vaccine; and rotavirus vaccine.”
  • Health Day lets us know,
    • “U.S. doctors should be on the lookout for a more severe strain of mpox that is spreading widely in parts of Africa, federal health officials warned Wednesday.
    • “The alert, issued by the U.S. Centers for Disease Control and Prevention, came just hours after the World Health Organization’s Director-General Dr. Tedros Adhanom Ghebreyesu tweeted that he will be gathering a group of advisers to decide whether the mpox outbreak in Africa should be declared a public health emergency of international concern.
    • “Cases of what is known as the clade 1 strain of mpox haven’t yet been reported outside of central and eastern Africa, the CDC noted in its alert. But the likelihood of additional spread prompted the agency to recommend that doctors in this country consider this more dangerous strain of mpox in patients who have recently been in the Democratic Republic of Congo (DRC) or any neighboring country (Angola, Burundi, Central Africa).
    • “Still, “due to the limited number of travelers and lack of direct commercial flights from DRC or its neighboring countries to the United States, the risk of clade I mpox importation to the United States is considered to be very low,” the CDC added.”
  • The American Hospital Association News alerts us,
    • “The AHA yesterday sent a Special Bulletin to members notifying them of concerns by the American Red Cross, America’s Blood Centers and the Association for the Advancement of Blood and Biotherapies about the nation’s low supply of blood levels. Each of those organizations is urging individuals to donate to boost supplies. The blood groups said this summer’s record heat, as well as recent disruptions in blood collections in the Southeast United States — including a cyberattack on OneBlood and the Tropical Storm Debby — have created additional challenges for blood collection. The AHA is urging its members to ask their communities to donate blood.”
  • Medscape offers a commentary explaining why “Sex, Marriage, Race, Education: Four Factors Account for 18 Years of Life Expectancy.”
  • The FEHBlog post about a link to a Cleveland Clinic press release was missing the following quote from the document.
    • “New Cleveland Clinic research shows that consuming foods with erythritol, a popular artificial sweetener, increases risk of cardiovascular events such as heart attack and stroke. The findings, from a new intervention study in healthy volunteers, show erythritol made platelets (a type of blood cell) more active, which can raise the risk of blood clots. Sugar (glucose) did not have this effect.
    • “Published in Arteriosclerosis, Thrombosis and Vascular Biology, the research adds to increasing evidence that erythritol may not be as safe as currently classified by food regulatory agencies and should be reevaluated as an ingredient. The study was conducted by a team of Cleveland Clinic researchers as part of a series of investigations on the physiological effects of common sugar substitutes.” * * *
    • “I feel that choosing sugar-sweetened treats occasionally and in small amounts would be preferable to consuming drinks and foods sweetened with these sugar alcohols, especially for people at elevated risk of thrombosis such as those with heart disease, diabetes or metabolic syndrome,” [lead researcher] Dr. [Stanley] Hazen advises. “Cardiovascular disease builds over time, and heart disease is the leading cause of death globally. We need to make sure the foods we eat aren’t hidden contributors.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Merck & Co. has struck a deal worth up to $1.3 billion to buy an investigational drug targeting B-cell associated diseases.
    • “Merck on Friday said it will pay an initial $700 million to acquire full global rights to clinical-stage bispecific antibody CN201 from privately held biotechnology company Curon Biopharmaceutical.
    • “Merck said CN201 is currently in studies in patients with relapsed or refractory non-Hodgkin’s lymphoma and B-cell acute lymphocytic leukemia.
    • “The Rahway, N.J., drugmaker said it plans to evaluate CN201 as a treatment for B-cell malignancies and to investigate its potential to provide a novel, scalable option for the treatment of autoimmune diseases.
    • “Merck said Curon also is eligible to receive up to $600 million in milestone payments associated with the development and regulatory approval of CN201.
    • “The company said it expects to complete the acquisition in the third quarter, adding that it will book a pretax charge of about $750 million, reflecting the upfront payment and other related costs.”
  • and
    • “Novo Nordisk had a big head start in the race to dominate the weight-loss market. But Eli Lilly is catching up fast.
    • “The two companies’ divergent earnings reports this week showed that Indianapolis-based Lilly is moving faster than its Denmark-headquartered counterpart in the race to win the GLP-1 war.” 
  • Healthcare Finance notes,
    • “Johns Hopkins Health Plans is wading further into the artificial intelligence waters with a partnership meant to ensure member compliance with the No Surprises Act.
    • “By adopting InsightPro from MDI NetworX, Johns Hopkins Health Plans (JHHP) is addressing what it sees as an issue surrounding the No Surprises Act: While the law created transparency for patients and protection against unexpected billing, it also brought new compliance requirements that left many health plans “scrambling,” according to Johns Hopkins.
    • “Ryan O’Donnell, chief operating officer for Johns Hopkins Health Plans, called the technology “innovative” and said it would ensure members have accurate, up-to-date provider information, and would promote trust in the company’s services.”
  • Kaufmann Hall posted an infographic on the state of American medical debt.
    • About 8% of American adults have at least some medical debt, although this percentage is much higher among certain populations including those in poor health, the uninsured, and Black Americans. The 14% of Americans who owe over $10K carry over three-quarters of the nation’s total medical debt burden. In contrast, the nearly 50% of Americans who owe less than $2K are responsible for just 5% of the medical debt total. Reporting changes recently implemented by the three major credit rating agencies have reduced the impact of medical debt on other aspects of consumers’ financial health, but mostly for smaller medical debtholders. By excluding medical debt in collections for less than a year as well as medical debt of less than $500 from appearing on credit reports, the share of Americans whose medical debt affects their credit score has dropped to 5%. 

Thursday Miscellany

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Fierce Healthcare lets us know,
    • “The Department of Health and Human Services’ technology office dropped a new proposed rule on Thursday that would require healthcare entities that contract with HHS to use government-certified health information technology. 
    • “One group said the proposed rule could expand ASTP/ONC’s scope beyond setting standards for electronic health records (EHRs) to include data systems used by public health entities and insurers’ information systems. The proposed rule could potentially impact the regulation of artificial intelligence and cybersecurity in healthcare, a source said.
    • “The  Office of the Assistant Secretary of Technology Policy’s proposed rule, “Acquisition Regulation: Information Technology; Standards for Health Information Technology” proposes that health IT meet ONC standards requirements when: solicitations and contracts issued by or on behalf of HHS entities involve implementing, acquiring or upgrading health IT where individually identifiable health information (IIHI) is exchanged; and, health IT is used by healthcare providers, health plans, or health insurance issuers under HHS contracts.
    • “The proposed rule would also include healthcare providers who have been eligible to participate in CMS’s health IT-focused incentive programs.”
  • MedTech Dive tells us,
    • “The Centers for Medicare and Medicaid Services shared a final notice on Wednesday for a new pathway to cover breakthrough medical devices. 
    • “The pathway, called Transitional Coverage for Emerging Technologies (TCET), is intended to expedite Medicare coverage of new medical devices. On average, it takes about five years after a device is authorized by the Food and Drug Administration to gain national Medicare and commercial insurance coverage, according to a survey by the Stanford Byers Center for Biodesign. 
    • “The CMS plans to accept up to five candidates per year for the TCET pathway, with the goal of finalizing a national coverage determination within six months of FDA market authorization for technologies that are accepted. The devices must have the FDA’s breakthrough designation, meaning they provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions.
    • “Medtech lobbying firm Advamed pushed back on the five devices per year cap. CEO Scott Whitaker said in a Thursday statement that the limit “demonstrates clearly to Congress the need for greater resources at CMS” and the exclusion of diagnostics from the pathway is “disappointing.” 
  • The Congressional Research Service posted a legal sidebar titled “Private Equity Investments in Healthcare: Selected Enforcement Issues.”
  • STAT News reports,
    • “A federal judge [who sits on the bench of the U.S. District Court for the Southern District of Ohio] on Thursday tossed out a U.S. Chamber of Commerce lawsuit challenging Democrats’ drug pricing law.”
    • “The decision is yet another loss for the pharmaceutical industry and its allies, which have filed lawsuits across the country arguing that the Inflation Reduction Act, which created a drug price negotiation program in Medicare, is unconstitutional. So far, they have lost every one.” * * *
    • “Because the case wasn’t filed in the correct court, Judge Newman didn’t address substantive issues about whether the law is constitutional or not.
    • “Medicare officials are expected to release the outcome of the price negotiations for the first 10 drugs in the program by Sept. 1.”
  • Per Federal Network News,
    • “The Postal Service is seeing steady growth in revenue, but not enough to outpace its substantial operating costs.
    • “USPS saw a $2.5 billion net loss for the third quarter of fiscal 2024 — higher than the $1.7 billion net loss it saw for the same period last year.
    • “USPS reported $18.8 billion in revenue this quarter — 1% higher than revenue for the same quarter last year. It’s also the agency’s fourth consecutive quarter of revenue growth.
    • “However, the agency also saw a more than 4% increase in its operating costs, which grew to more than $21 billion for the quarter.
    • “Postmaster General Louis DeJoy said Thursday that USPS plans to accelerate efforts to cut costs and boost revenue.”

From the public health and medical research front,

  • The Hill reports,
    • “Fewer U.S. adults today say it is important to get children vaccinated than in recent years, according to a Gallup poll published Wednesday.
    • “In the July survey, only 40 percent of U.S. adults said it is “extremely important” for parents to vaccinate their children, a marked decline from the 58 percent who said the same in 2019 and the 64 percent who said the same in 2001.
    • “The drop over the last two decades is similarly stark when tracking the combined percentage who said vaccinating children is either “extremely” or “very” important. Taken together, 69 percent of U.S. adults hold this view now, down from 84 percent in 2019 and from 94 percent in 2001.” * * *
    • “The poll included phone interviews conducted July 1-21, with 1,010 adults. The margin of error is 4 percentage points.”
  • The New York Times points out,
    • “Scientists have developed a new weapon against H.I.V.: a molecular mimic that invades a cell and steals essential proteins from the virus.
    • “A study published in Science on Thursday reported that this viral thief prevented H.I.V. from multiplying inside of monkeys.
    • “The new therapeutic approach will soon be tested in people, the scientists said. Four or five volunteers with H.I.V. will receive a single injection of the engineered virus. “This is imminent,” said Leor Weinberger, a virologist at the University of California, San Francisco, who led the new study.” * * *
    • “Asher Leeks, a virologist at Yale University who was not involved in the research, said that it represented a big step forward in the study of so-called cheating viruses. Researchers have been investigating them for decades, but only in recent years have scientists like Dr. Weinberger tried turning them into medical treatments.”
  • Per a Cleveland Clinic press release,
    • New Cleveland Clinic research shows that consuming foods with erythritol, a popular artificial sweetener, increases risk of cardiovascular events such as heart attack and stroke. The findings, from a new intervention study in healthy volunteers, show erythritol made platelets (a type of blood cell) more active, which can raise the risk of blood clots. Sugar (glucose) did not have this effect.
    • Published in Arteriosclerosis, Thrombosis and Vascular Biology, the research adds to increasing evidence that erythritol may not be as safe as currently classified by food regulatory agencies and should be reevaluated as an ingredient. The study was conducted by a team of Cleveland Clinic researchers as part of a series of investigations on the physiological effects of common sugar substitutes. * * *
    • “I feel that choosing sugar-sweetened treats occasionally and in small amounts would be preferable to consuming drinks and foods sweetened with these sugar alcohols, especially for people at elevated risk of thrombosis such as those with heart disease, diabetes or metabolic syndrome,” Dr. Stanley Hazen advises. “Cardiovascular disease builds over time, and heart disease is the leading cause of death globally. We need to make sure the foods we eat aren’t hidden contributors.”
  • The Wall Street Journal reports,
    • “Millions of people are flocking to drugs like Ozempic and Wegovy to lose weight and treat health problems. Doctors say one group that could benefit from the drugs is missing out: seniors.
    • “For older people, these medications can help in ways that go beyond losing weight, physicians say. Fewer pounds can lead to more mobility and better balance, allowing older people to become more active. That can boost mood, overall health, and sometimes makes the difference between walking freely or using a wheelchair or cane. 
    • “Doctors say they’re hearing more from older people who are interested in taking the drugs. However, seniors face [Medicare] insurance hurdles to get the drugs covered. And doctors note that older people need to be careful about losing muscle mass when on the drugs, as well as possible interactions with other medications.    
    • “Nine percent of people 65 and older reported taking GLP-1 medications, such as Ozempic, Wegovy and Zepbound, compared with 19% of people ages 50 to 64, according to a May KFF poll.
    • “These drugs would really benefit seniors but there’s always these additional worries,” says Dr. Sun Kim, an associate professor in the division of endocrinology at Stanford University School of Medicine. “I think sometimes we prioritize the risk over benefit when people get older.” 
  • and
    • “Doctors are now capable of saving the lives of babies born at 22 weeks and, in rare cases, a week earlier, with improved techniques to help tiny lungs develop and protect fragile skin and organs. Hospitals with extensive experience resuscitating extremely premature babies report survival rates as high as 67% for babies born at 22 weeks.
    • “Some U.S. hospitals aren’t sufficiently equipped or capable of pulling off the new advances. Others have chosen not to offer the care, saying it is likely to fail, is expensive—typically more than $100,000 a child, and sometimes much more—and subjects tiny, fragile infants to needless pain and the risk of long-term disabilities. 
    • “Instead, they often provide comfort care: wrapping the newborn in a blanket, placing it on the mother’s chest and sometimes giving medicines to ease the child’s final moments.
    • “The difference can be a matter of life or death for the roughly 8,000 infants born between 22 and 24 weeks gestation in the U.S. each year.
    • “Doctors agree that babies born at 25 or 26 weeks can and should be treated as long as they don’t have other complications, while those born at 20 weeks or less are too small to save.
    • “In between is a “gray zone,” as doctors call it, where newborns’ fate can depend on which hospital happens to be delivering.”
  • STAT News tells us,
    • “Since its emergence in 2020, Covid has jumbled the list of the 10 leading causes of deaths in the United States. It roared into third place in 2020 but has now fallen to 10th place, the National Center for Health Statistics reported Thursday. 
    • “Heart disease and cancer remained the first and second leading causes of death, followed by unintentional injuries as No. 3. Overall, deaths in 2023 were 6.1% lower than 2022.
    • “We’re going in the wrong direction for heart disease. We’re going a tad in the right direction for cancer,” said Eric Topol, founder and director of the Scripps Research Translational Institute. A cardiologist and geneticist, he was not involved in the analysis. “A lot of things that are highest on this list, there’s a lot of things we can do to prevent them. And hopefully we’ll keep seeing the numbers come down. But if you just look at pre-pandemic to now, it’s not a good trend.”
  • Per Healio,
    • “The Simplera Continuous Glucose Monitor features a one-hand, two-step insertion process for the sensor that does not require additional tape.
    • “The [recently] FDA-approved device is part of Medtronic’s smart multiple daily injection system.

From the U.S. healthcare business front,

  • The Wall Street Journal relates,
    • “Eli Lilly shares jumped after the drugmaker reported earnings that trumped analyst estimates and hiked its annual outlook.
    • “Lilly has become one of the most valuable companies listed in the U.S. due to the popularity of its medications used for obesity.
    • “Quarterly sales for diabetes drug Mounjaro totaled more than $3 billion, while weight-loss injection Zepbound, which launched late last year, rang in at $1.2 billion. Both figures beating analysts’ estimates.
    • “The strong quarter was boosted in part by additional supply of the drugs, which had been in shortage, as well as favorable pricing, Lilly said. Mounjaro prices were higher in the U.S., partly because of increased availability of the drug and lower use of savings card programs.”
  • Following up on a post from yesterday, BioPharma Dive informs us,
    • “[Mounjaro and Zepbound] are available in all dosage forms in the U.S. What that means is we can bill orders as they’re received,” said Lilly CEO David Ricks on an earnings conference call Thursday. “That does not mean that any pharmacy, or certainly every pharmacy, has all 12 dosage forms sitting on their shelves.”
    • “Ricks cautioned that, despite the change in status on the FDA’s shortage list, patients may still have to wait a few days to pick up their prescriptions.
    • “There’s not an abundance of supply. It’s more of a real-time fulfillment situation,” Ricks said. “But product is flowing and it’s flowing at a pretty high rate.”
    • “Still, he added, “the end pharmacy experience will continue to be choppy.”
  • Forbes adds,
    • “More doses of Novo Nordisk’s popular weight loss drug Wegovy are back in stock in the U.S. after years of shortages, according to the FDA, days after all dosage levels of Eli Lilly’s rival injection Zepbound became available. They’re part of a promising and growing class of drugs called GLP-1 agonists, but shortages are set to persist as pharmaceutical companies struggle to ramp up production.”
  • STAT News notes,
    • “As for-profit Tenet Healthcare slims its hospital portfolio, it found an unlikely buyer for its Alabama hospitals: Florida’s Orlando Health.  
    • “Orlando Health draws more than $6 billion in annual revenue and has a profit margin that surpasses most of its peers. A hospital system executive system leader said crossing state lines to buy five Birmingham-area hospitals is part of its focus on serving the Southeastern U.S., even though most of its 17 existing hospitals are still in Florida. 
    • “It’s not at all surprising that a multi-billion dollar health system would have ambitions of expanding beyond its home state. That’s especially true as hospital systems continue to merge at a breakneck pace, increasingly jumping across multiple states to do so. Meanwhile, study after study concludes that hospitals use their newfound market power to drive up prices.”
  • Per Beckers Hospital Review
    • “As the Medicare Advantage landscape evolves, the success of health systems hinges on their ability to adapt and excel in key areas such as star ratings and appropriate coding. 
    • “Health systems’ greatest opportunity is to enter into full-risk arrangements with health plans, shifting the focus from managing illness to maintaining wellness. However, many systems have not made the necessary investments to thrive in this value-based care model, often missing out on its potential benefits and driving ambivalence toward the MA program, according to SCAN Group CEO Sachin Jain, MD.”
  • Fierce Healthcare adds,
    • “Centene is exiting six states through its WellCare Medicare Advantage (MA) subsidiary next year, investment bank Stephens has revealed.
    • “Those six impacted states are Alabama, Massachusetts, New Hampshire, New Mexico, Rhode Island and Vermont, with approximately 12,600 members affected in New Mexico, the most of any state.
    • “In Vermont, Centene accounts for about 9% of the market share in the state. All told, all market exits will impact around 37,300 members and about 3% of Centene’s current MA membership, a research note from Stephens showed.
    • “Notably, CVS and UnitedHealthcare both maintain presences across each impacted market,” the brief said.
    • ‘The insurer will still offer its prescription drug plans in these states. Centene commands the most market share for standalone Part D in the country at 29%, data from the Centers for Medicare & Medicaid Services show.
  • Per Healthcare Dive,
    • “Walgreens is considering a full sale of its stake in VillageMD, after pouring billions of dollars into the unprofitable primary care chain. The decision, disclosed Wednesday in a securities filing, is a sharp reversal to the pharmacy behemoth’s past commitment to building out its healthcare delivery offerings.
    • “Walgreens is “currently evaluating a variety of options” in light of VillageMD’s “substantial ongoing and expected future cash requirements,” the company said in the 8-K. “These options could include a sale of all or part of the VillageMD businesses, possible restructuring options and other strategic opportunities.”
    • :If Walgreens offloads VillageMD entirely, it would be a step up from management’s previous plans for the value-based medical chain. In June, Walgreens said it would reduce ownership in VillageMD but not eliminate it entirely.”
  • STAT News lets us know,
    • “Digital Therapeutics developer Big Health this week received Food and Drug Administration clearance for SleepioRx, a prescription treatment for insomnia.
    • “Big Health already sells a wellness version of the app, called Sleepio, to employers and health plans that make the product available to their members. The app delivers a specialized type of cognitive behavioral therapy for insomnia and the company boasts that it is backed by dozens of studies.”
  • Per BioPharma Dive,
    • “Sarepta Therapeutics’ yearly financial outlook and quarterly earnings, including sales of Elevidys, its gene therapy for Duchenne muscular dystrophy, have fallen well short of Wall Street expectations.
    • “Sarepta reported Wednesday afternoon that Elevidys sales totaled roughly $122 million between April and June, down from the previous quarter and about $20 million below consensus estimates. Overall product sales of about $361 million, and 2025 revenue projections of $2.9 billion to $3.1 billion, were also lower than analysts anticipated.
    • “Still, executives assured investors that sales should soon climb following the recent decision by the Food and Drug Administration to substantially expand use of Elevidys. The market opportunity ahead of Sarepta is “absolutely massive,” said Dallan Murray, the company’s executive vice president and chief customer officer on a conference call. Sarepta shares initially fell by double digits before rebounding Thursday morning.”
  • Per MedTech Dive,
    • “Zimmer Biomet said Wednesday it agreed to buy Orthogrid Systems, a medtech company that makes artificial intelligence-based surgical guidance systems for total hip replacement. 
    • “Salt Lake City-based Orthogrid uses fluoroscopy imaging to help surgeons track the position of an implant during a hip procedure. It also has two other Food and Drug Administration-cleared solutions for hip preservation and trauma surgeries. 
    • “By using fluoroscopy instead of CT scans, Orthogrid can offer real-time navigation and a more efficient workflow for operating rooms.
    • “The solution will add to Zimmer’s current suite of tools for hip surgery. The company has its own hip application paired with its Rosa surgical robot that also uses fluoroscopy imaging. Zimmer additionally has a co-marketing agreement with HipInsight, which uses Microsoft Hololens 2 glasses to help surgeons visualize a patient’s pelvic anatomy during surgery. 
    • “By comparison, Stryker’s Mako total hip application uses CT imaging, while J&J’s Velys hip navigation uses fluoroscopy.”   

Midweek Update

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, Medicare, OPM, U.S. Healthcare, Uncategorized–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Govexec reports,
    • “Federal agencies have not implemented roughly half of the 428 recommendations that the Government Accountability Office has made to improve preparedness following the COVID-19 pandemic, which has killed 1.2 million Americans. 
    • “In a report published on Aug. 1, the watchdog reviewed its oversight work concerning COVID-19 and the approximately $4.65 trillion Congress provided in response. GAO found that agencies haven’t addressed 220 of its recommendations. 
    • “Reflecting on federal agencies’ emergency response actions and our recommendations can reveal lessons from the COVID-19 pandemic for federal agencies. These lessons can help federal agencies identify actions that successfully facilitated the implementation of the federal response and should be incorporated into future emergency response plans. Other lessons can help federal agencies identify weaknesses in their response to the pandemic and identify areas for improvement,” GAO investigators wrote.”
  • Per an HHS press release,
    • “Today, to mark National Health Center Week, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), awarded nearly $9 million to 18 HRSA-funded health centers to improve access to life-saving cancer screenings in underserved communities. Health centers will partner directly with National Cancer Institute-Designated Cancer Centers to expedite patient access to cancer care and treatment. These awards advance the Biden Cancer Moonshot mission to prevent 4 million cancer deaths by 2047 and end cancer as we know it. This effort builds on work supported by the 21st Century Cures Act to expand use of proven cancer prevention and early detection strategies to reduce cancer risk in all populations.”
  • Federal News Network tells us about OPM telework guidance issued today.
    • “In the federal government’s case, remote work is distinct from telework. Federal employees with remote work agreements perform their job duties at a location away from their normal work site without the expectation of regularly returning to that site. In contrast, federal employees with telework agreements, by OPM’s definition, can perform their work away from the office — but are still expected to come to the worksite “on a regular and recurring basis.”
    • “OPM’s new guidance doesn’t change the definitions for federal remote work or telework, which are set in law, but rather provides additional clarifying guidance on how agencies should approach their workplace arrangements moving forward. In the document, OPM details what factors agencies should consider as they hammer out their remote work posture — both as it currently exists, as well as what it will look like in the future.
    • “The guidance builds on the Office of Management and Budget’s April 2023 memo that called on agencies to strike a balance between in-person work and telework, as well as 2021 OPM guidance that told agencies to weave telework and remote work into their workforce culture. Following those documents, OPM said human capital leaders and other senior executives asked for additional guidance on how to ensure agencies are relatively consistent as they consider changes to their remote work arrangements.
    • “OPM said it’s still up to each agency to determine the right balance for workplace flexibilities, such as remote work, for their employees. Agencies can decide if they want to offer remote work in the first place. They also have the authority to determine how they’d like to use the flexibility, and what positions are potentially good candidates for the alternative workplace arrangements.”

From the public health and medical research front,

  • American Hospital Association lets us know,
    • “The Centers for Disease Control and Prevention has updated respiratory syncytial virus vaccination recommendations for adults 60 and older. Adults aged 60-74 at increased risk for RSV and all aged 75 and older are recommended a single dose of the GSK, Pfizer or Moderna vaccine. Individuals who previously received a dosage should not seek another.” 
  • The New York Times reports,
    • “When exposed to a virus, the human body marshals the immune system to fend off the intruder. Sometimes, the defense goes awry, and the body mistakenly turns against itself instead of the attacker.
    • “This sort of friendly fire drives multi-inflammatory syndrome in children, or MIS-C, a mysterious condition that in rare cases strikes children who have had a severe bout of Covid-19, according to a new study.
    • “In a subset of children with the syndrome, immune cells become confused by the similarity between a protein carried by the coronavirus, and one found throughout the human body, said Joseph DeRisi, an infectious disease expert and the president of the Chan Zuckerberg Biohub in San Francisco, who led the study. This phenomenon is called molecular mimicry, Dr. DeRisi said.
    • The study was published on Wednesday in the journal Nature. The results offer the first direct proof that Covid-19 sets off an autoimmune reaction that leads to MIS-C.”
  • The Wall Street Journal alerts us,
    • “Antidepressants are one of several classes of medications that can make people more vulnerable to heat by tampering with the body’s internal thermostat or interfering with its cooling strategies. Others include antipsychotics, diuretics, stimulants and heart medications such as beta blockers and ACE inhibitors. 
    • “The risk is growing during longer, more frequent heat waves: Last summer was the hottest on record, and this one is setting records, too. The rate of emergency-room visits for heat-related illnesses was higher last summer than in the previous five.” * * *
    • “Many of these drugs are associated with an increased risk of heat-related hospitalizations, a study published in 2020 in the journal PLOS One found. But the extent to which these drugs pose risks isn’t well studied, said Dr. Soko Setoguchi, an epidemiologist at Rutgers University who co-wrote the study. Setoguchi said people should avoid heat, not their medication.”
  • Beckers Hospital Review informs us,
    • “Neuralink, a company co-founded by Elon Musk, has successfully implanted a second brain-computer interface device into a human subject, Nature reported Aug. 6.
    • “During a podcast released Aug. 2, Mr. Musk said the new implant is functioning well, with around 400 of its 1,042 electrodes actively transmitting signals from the person’s brain.
    • “Although details regarding the recipient or the specifics of the surgery were not disclosed, Mr. Musk said the individual, similar to the first recipient, suffers from a spinal cord injury. 
    • “The procedure comes after Neuralink’s first patient had a number of threads on the implant retracted from his brain shortly after the surgery.”
  • and
    • “New York City-based Hospital for Special Surgery has the lowest hospital wide readmission rate, according to CMS’s Unplanned Hospital Visits database.
    • “The data, released July 31, is based on provider data for hospital return days, including unplanned readmission measures in 2022.”
    • The article lists “the 10 hospitals with the highest and lowest hospital wide readmission rates, along with their respective scores.”
  • STAT News notes,
    • “Novo Nordisk is pulling its regulatory submissions to expand the use of its obesity drug Wegovy for a common type of heart failure, saying that waiting for more data on cardiovascular outcomes could bolster its case.
    • “Trials of Wegovy in the condition, heart failure with preserved ejection fraction (or HFpEF), have primarily looked at the drug’s effects on symptoms and physical function. The company plans to reapply to expand Wegovy’s label early next year when it has more data on complications such as hospitalizations and cardiovascular-related deaths, Martin Lange, Novo’s head of development, said Wednesday on an earnings call.” 
  • Per a National Institutes of Health press release,
    • “A National Institutes of Health (NIH)- supported study has found race- and sex-based differences in the increased chances of survival from people who received bystander cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest. Average survival benefits for cardiac arrest, when the heart suddenly stops beating, could be three times as high for white adults compared to Black adults and twice as high for men compared to women. The findings published in Circulation.
    • “CPR saves lives — that, we know,” said Paula Einhorn, M.D., a program officer at NIH’s National, Heart, Lung, and Blood Institute (NHLBI). “Yet the disparities revealed in this research show we need to do more to understand how to ensure equitable outcomes for all patients needing CPR. We’re hoping new insights will lead to better survival * * *.” * * *
    • “Prior research already found inequities in the frequency with which bystander CPR was being performed in Black and Hispanic individuals compared to white individuals, and with women compared to men in public places. In response, CPR training awareness and programs have expanded nationally, as have online courses. Mannequins resembling a woman’s body have also been designed.
    • “Evaluating access to and the effectiveness of different types of CPR trainings could be one way to identify differences in survival outcomes and inform solutions, according to researchers. For example, future studies could inquire about whether a bystander received online or in-person training; if they practiced on women mannequins or models with black or brown skin; if multiple bystanders were around, which may indicate a person had additional support; and what kind of support from emergency dispatchers they had — and for how long — which may reveal whether a person was receiving CPR instructions for the first time. Since the arrival times of emergency medical responders were fairly similar among groups, the researchers don’t believe this factored into outcomes observed in the study. Future studies could also explore the role that underlying health conditions may have in the survival outcomes of those who needed CPR.”

From the U.S. healthcare business front,

  • MedCity News reports,
    • “Hospital finances seem to be stabilizing overall — but a closer look shows that there is a widening gap between the highest- and lowest-performing organizations, according to a report released by Kaufman Hall this week.
    • “For the report, Kaufman Hall examined data from more than 1,300 hospitals. It showed that hospitals’ year-to-date operating margin index held steady at 4.1% in June for the second month in a row.” * * *
    • “Kaufman Hall also released another report on healthcare finances this week, with this one showing that rising labor costs are here to stay.: * * *
    • “This aligns with recent research from Strata Decision Technology, which showed that healthcare providers’ labor expenses grew by 5.2% while their non-labor costs rose by 3.3% from June 2023 to June 2024. This resulted in a 4.8% increase in overall expenses during the 12-month period, according to the report.” 
  • Healthcare Dive adds
    • “Tenet Healthcare will sell its majority ownership in Birmingham, Alabama-based Brookwood Baptist Health for about $910 million to Orlando Health, the health system said Monday.
    • “The sale, which is expected to close in the fall of this year, includes 70% of Tenet’s interest in the five-hospital system, as well as affiliated physician practices and other related operations. 
    • “The deal continues Tenet’s streak of divestitures as it looks to deleverage its portfolio. This year, the system has sold nine hospitals to Novant Health, UCI Health and Adventist Health for a combined after-tax profit of $3 billion.”
  • Beckers Payer Issues discusses payer efforts to defend affiliated prescription benefit managers.
  • The Wall Street Journal reports
    • “CVS Health’s Medicare business continued to struggle in the second quarter, fueling yet another cut to its full-year earnings outlook, a new $2 billion cost-cutting plan and the departure of a top executive. 
    • “CVS bet big on attracting seniors to its Aetna Medicare Advantage health plans last year, adding one million new people to its insurance rolls in 2024. But the gamble began backfiring in the first quarter of the year as seniors used more healthcare services than in the past and the government has become stingier in how much it pays private insurers. 
    • “On Wednesday, CVS said the pressures continued into the second quarter. The company reported total revenue of $91.2 billion in the quarter, up 2.6% from a year ago, and driven in large part by growth in its Medicare and commercial insurance businesses. 
    • But much of the sales increase was eaten up by higher medical costs, and adjusted earnings per share of $1.83 in the quarter were down 17.2% from last year. 
  • Beckers Payer Issues adds,
    • “Medicare Advantage costs could rise in the second half of 2024, CVS Health CEO Tom Cowhey told investors. 
    • “On an Aug. 7 call, Mr. Cowhey said costs in inpatient care, dental and pharmacy all rose toward the end of the second quarter. The company’s guidance for the rest of the year reflects that costs in the second half of the year could be higher than the first, the CFO said.” * * *
    • “Revenues in the company’s health benefits segment are down 40% year over year. The company ousted Aetna President Brian Kane over the financial results. Ms. Lynch and Mr. Cowhey will oversee Aetna’s day-to-day operations until a successor is named.” 
  • Per BioPharma Dive,
    • “Novo Nordisk shares tumbled 7% in early trading Wednesday after the company reported lower-than-expected revenue from its blockbuster obesity franchise.
    • “Even as revenue from Wegovy and Ozempic continued to soar, the second-quarter numbers failed to reach the high expectations set by Wall Street, analysts said. Sales of the so-called GLP-1 obesity drugs were about 9% below consensus estimates, according to analysts with the investment bank Jefferies.
    • “Overall revenue for the second quarter was “borderline in line with expectations,” Stifel analyst Eric Le Berrigaud wrote in a note to clients. But the fact that older products in Novo Nordisk’s portfolio helped offset the disappointing results for obesity drugs “is not so reassuring in the long term,” he wrote. The company’s “sales composition is not good.”
  • and
    • “The first medicine approved for a liver disease known as MASH is off to a faster launch than Wall Street analysts expected, according to quarterly results disclosed Wednesday by developer Madrigal Pharmaceuticals.
    • “Madrigal said its drug Rezdiffra, which was approved by the Food and Drug Administration in March and became available the following month, generated $14.6 million in U.S. sales in the second quarter. As of June 30, more than 2,000 patients were on treatment and coverage policies were in place for more than 50% of people with commercial health insurance, the company said.
    • “While only an early snapshot, the results surpassed consensus analysts estimates of about $4 million and have encouraged Madrigal to commercialize Rezdiffra in Europe on its own. An approval decision there is expected next year. “We’re still in the early stages, but we are confident that we’re building the foundation needed to create a blockbuster medicine,” CEO Bill Sibold told analysts.”

Tuesday Tidbits

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Per a Senate press release,
    • “Lawmakers are calling on the Government Accountability Office (GAO) to review the Medicare Part D Premium Stabilization Demonstration recently announced by the Centers for Medicare & Medicaid Services (CMS), noting its dubious legality and the danger it poses to health care affordability for seniors.  The effort comes as part of a letter to GAO from U.S. Senate Finance Committee Ranking Member Mike Crapo (R-Idaho), U.S. House Ways and Means Committee Chair Jason Smith (R-Missouri) and U.S. House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Washington).
    • “Through new taxpayer-financed policy adjustments, the demonstration seemingly intends to deflate seniors’ premiums that are otherwise slated to increase dramatically following the counterintuitive, haphazardly-written Inflation Reduction Act’s drug price provisions.  However, the agency has not produced any budgetary analysis and appears to lack a clear statutory basis or credible research goals for the proposal.  Crapo, Smith and McMorris Rodgers request GAO review the demonstration’s legality under section 402 of the Social Security Amendments of 1967; what budgetary analysis CMS undertook in developing the demonstration; and the estimated budgetary impact of the demonstration.”
  • FedWeek discusses similarities and differences between the House and Senate appropriations bills concerning federal workforce issues. For example,
    • “Both of the appropriations bills meanwhile would continue several long-running workplace policies that must be renewed annually. These include a general requirement that FEHB plans cover prescription contraceptives but not abortion; a ban on training not directly related to an employee’s official duties; and a ban on studying commercial type federal jobs for possible contracting-out.”
  • Reg Jones, writing in FedWeek, explains the nuts and bolts of FEHB coverage of young adult children.
  • Govexec informs us,
    • “The federal government’s dedicated HR agency reported a slight uptick in its backlog of pending federal employee retirement claims for the second straight month in July.
    • “Last month, the Office of Personnel Management reported that it received 6,451 new retirement requests, a decrease of roughly 450 cases from June. But despite increasing its output by more than 300 cases, processing 5,994 claims was not enough to stop the backlog from climbing from 15,340 in June to 15,797 last month.
    • “OPM’s goal is a “steady state” backlog of 13,000 pending claims in any given month. Since the backlog hit an eight-year low of 14,035 in May, the backlog has increased by nearly 1,800 cases.
    • “As a result, the monthly average processing time for a federal worker’s retirement request has increased from 61 days in May to 65 at the end of last month. Measured since the beginning of fiscal 2024 last October, the average wait time has remained static at 61 days since March.”

From the public health and medical research front,

  • The New York Times reports,
    • “In 2021, a survey by the Centers for Disease Control and Prevention on teen mental health focused on a stark crisis: Nearly three in five teenage girls reported feeling persistent sadness, the highest rate in a decade.
    • “But the newest iteration of the survey, distributed in 2023 to more than 20,000 high school students across the country, suggests that some of the despair seen at the height of the pandemic may be lessening.
    • “Fifty-three percent of girls reported extreme depressive symptoms in 2023, down from 57 percent in 2021. For comparison, just 28 percent of teenage boys felt persistent sadness, about the same as in 2021.
    • “Suicide risk among girls stayed roughly the same as the last survey. But Black students, who reported troubling increases in suicide attempts in 2021, reported significantly fewer attempts in 2023.” * * *
    • “For young people, there is still a crisis in mental health,” said Kathleen Ethier, head of the C.D.C.’s adolescent and school health program. “But we’re also seeing some really important glimmers of hope.”
  • WorldatWork informs us
    • “Current events and uncertainty about what the future holds is causing anxiety to increase at an alarming rate among U.S adults, according to the American Psychiatric Association’s 2024 mental health poll. This year’s version of the annual APA poll showed 43% of surveyed adults feel more anxious than they did last year, up from 37% in 2023 and 32% in 2022.
    • “According to the poll, which surveyed more than 2,200 adults, people are particularly anxious about current events, with 77% citing the economy as their greatest worry, while 73% of adults are anxious about the 2024 presidential election and 69% are anxious about gun violence.
    • “Other anxiety-inducing topics cited in the survey include safety related to family, self and identity; issues related to health; the ability to pay bills; climate change; the opioid epidemic; and advances in technology impacting day-to-day life. Americans also cited issues such as stress, sleep and social connections as contributing factors to their mental health.”
    • The article explains steps employers can take to help their employees with such problems.
  • The Wall Street Journal reports on an encouraging new approach to rotator cuff surgery that is based on the tooth structure of python snakes.
    • “When it comes to rotator cuff tendon tears, surgeons are trying to repair soft tissue back to bone, which is really stiff,” said Iden Kurtaliaj, lead author of the paper and a former biomedical engineering graduate student at Columbia. “So, if python snakes are capable of grasping soft tissue without tearing through it, [we thought] ‘Can we apply this concept to rotator cuff repairs?’”
    • “The device attaches to the shoulder bone and the tendon like a python grabs its prey, according to Kurtaliaj. In early experiments, the implant doubled the strength of repairs compared with commonly used suture restoration.”
    • The approach needs more refinement and government approval before it’s ready for prime time.
  • The New York Times lets us know,
    • “The United States spent $43 billion annually on screening to prevent five cancers, according to one of the most comprehensive estimates of medically recommended cancer testing ever produced.
    • “The analysis, published on Monday in The Annals of Internal Medicine and based on data for the year 2021, shows that cancer screening makes up a substantial proportion of what is spent every year on cancer in the United States, which most likely exceeds $250 billion. The researchers focused their estimate on breast, cervical, colorectal, lung and prostate cancers, and found that more than 88 percent of screening was paid for by private insurance and the rest mostly by government programs.
    • “Dr. Michael Halpern, the lead author of the estimate and a medical officer in the federally funded National Cancer Institute’s health care delivery research program, said his team was surprised by the high cost, and noted that it was likely to be an underestimate because of the limits of the analysis.
    • “For Karen E. Knudsen, the chief executive of the American Cancer Society, the value of screening for the cancers is clear. “We are talking about people’s lives,” she said. “Early detection allows a better chance of survival. Full stop. It’s the right thing to do for individuals.”
  • The Wall Street Journal warns us,
    • “Drinking water is crucial for preventing dehydration and keeping the body functioning, particularly in the heat of the summer. But consuming too much over a short period can lead to health problems including disorientation, nausea, vomiting and, in severe cases, seizures or death.
    • “Overhydration could be a growing issue, some researchers say, as more people train for endurance competitions like marathons, heat waves become more frequent and reusable water bottles become a staple of everyday life. The message of staying hydrated is so ubiquitous that 40-ounce, stainless-steel tumblers have become status symbols. 
    • “People have this fear that they’re always dehydrated or underhydrated and they need to fix that regularly,” said Colleen Muñoz, director and co-founder of the Hydration Health Center at the University of Hartford. “That’s probably not usually the case.”
    • “Water intoxication isn’t as well-known as dehydration. That can make it difficult to pinpoint the cause of symptoms, which can be similar to those associated with heat exhaustion or heat stroke, said Rayven Nairn, senior dietitian for student health and well-being at Johns Hopkins University.” 
  • Per a National Institutes of Health press release,
    • “A new study from the NIH National Institute of Neurological Disorders and Stroke on the occurrence of active epilepsy in sexual and gender minorities (SGM) highlights the importance of health disparities research. It found that SGM individuals—those who identify as gay, lesbian, bisexual, queer, transgender, non-binary, or gender-diverse—are twice as likely to report active epilepsy compared to their non-SGM counterparts. “Active epilepsy” means a person has been diagnosed with epilepsy and has had more than one seizure in the past year or is currently taking anti-seizure medication.” 

From the U.S. healthcare business front,

  • Per Beckers Payer Issues,
    • “Premiums for plans on the ACA marketplace will rise 7% on average in 2025, according to an analysis from Peterson-KFF Health System Tracker published Aug. 5. 
    • “Most insurers participating in the marketplace requested premium increases between 5% and 10%. Around 15% of plans requested rate decreases, and less than 10% requested rate increases higher than 15%. 
    • “The report analyzed public reports insurers made requesting premium increases. Several insurers said GLP-1 drugs, including Ozempic and Wegovy, are one of the things driving premium increases. 
    • “The pharmacy trend, especially cost, is heavily influenced by the impact of GLP-1 drugs and their use in diabetes treatment as well as the expectation for continued use with the approval for expanded indications,” Priority Health, a Michigan insurer, wrote.”
    • “Read the full report here.“
  • Per Beckers Hospital Review,
    • “Becker’s has compiled a list of the hospitals patients are most likely to recommend in every state using [recent] Hospital Consumer Assessment of Healthcare Providers and Systems data from CMS.
    • “CMS shares 10 HCAHPS star ratings based on publicly reported HCAHPS measures. The recommended hospital star rating is based on patients’ responses to the question, “Would you recommend this hospital to your friends and family?” Hospitals must have at least 100 completed HCAHPS surveys in a four-quarter period to be eligible for a star rating. Learn more about the methodology here.”
  • and
    • “More than 700 rural U.S. hospitals are at risk of closure due to financial problems, with more than half of those hospitals at immediate risk of closure.  
    • “The latest analysis from the Center for Healthcare Quality and Payment Reform, based on CMS’s July 2024 hospital financial information, reveals the financial vulnerability of rural hospitals in two categories: risk of closure and immediate risk of closure.
    • “In the first category, nearly every state has hospitals at risk of closure, measured by financial reserves that can cover losses on patient services for only six to seven years. In over half the states, 25% or more of rural hospitals face this risk, with nine states having a majority of their rural hospitals in jeopardy.
    • “The report also analyzes hospitals facing immediate threat of closure meaning financial reserves could offset losses on patient services for two to three years at most. Currently, 360 rural hospitals are at immediate risk of shutting down due to severe financial difficulties.”
    • The article breaks down by U.S. state and DC the number of hospitals in each category.
  • Per BioPharma Dive, “Through a new deal, Roche has exclusive rights to Sangamo molecules designed to repress the gene that makes “tau,” a protein many scientists view as a main driver of Alzheimer’s.”
  • MedTech Dive reports,
    • “Labcorp has received de novo authorization for a kitted, pan-solid tumor liquid biopsy test, the company said Friday.
    • “The product, PGDx elio plasma focus Dx, is a targeted blood test that profiles 33 cancer genes.
    • “Securing Food and Drug Administration authorization expands the cancer portfolio that Labcorp has built since buying Personal Genome Diagnostics (PGDx) for $450 million in 2022.”
  • MedCity News lets us know,
    • “Bayer’s Kerendia, already FDA approved in one cardiometabolic indication, now has data from a pivotal test that support expanding the drug’s label to heart failure.
    • “In preliminary results reported Monday, Bayer said Kerendia reduced cardiovascular death and hospitalizations in heart failure patients, meeting the main goal of the Phase 3 clinical trial. The company did not release specific figures detailing the reductions, but said it will present the clinical data next month during the European Society of Cardiology Congress, which will be held in London. Bayer added that it plans to meet with the FDA to discuss a submission seeking regulatory approval for the drug in heart failure.”

Monday Roundup

David Ermer–CMS, COVID-19, FDA, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Per an HHS press release,
    • “Today, to mark National Health Center Week, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA) released new data showing over 31 million total patients served at HRSA-funded health centers in 2023—an increase of 2.7 million since 2020.
    • “Community health centers play a pivotal, and growing, role in America’s health care system. They are especially important in our effort to reduce health care disparities in underserved communities,” said HHS Secretary Xavier Becerra. “More than 31 million people across the country – in every U.S. state, territory, and the District of Columbia – depend on health centers, making them a vital resource. The Biden-Harris Administration wants all Americans to have access to high-quality primary health care services, regardless of a patient’s ability to pay, and community health centers help make that possible.”
  • Beckers Hospital Review delves into the final Medicare acute inpatient prospective payment rule for fiscal year 2025 which was publicized last week.
  • The Wall Street Journal reports,
    • “Studies being used to decide whether the U.S. should authorize an ecstasy-based drug for traumatized patients missed serious side effects and were marked by bias.
    • “The Food and Drug Administration is expected within days to decide whether to approve the drug, known as MDMA, for treatment of post-traumatic stress disorder. Approval would be a milestone in decades of efforts to decriminalize the use of psychedelics. 
    • “Three people who were subjects in the studies told The Wall Street Journal that their thoughts of suicide worsened during or after testing, but their downward slides weren’t captured in trial data and therefore not reflected in the final results.” * * *
    • “FDA staffers have questioned the quality of the study results. Experts advising the agency recommended against approval, saying more safety and effectiveness evidence was needed. The Institute for Clinical and Economic Review, a nonprofit that reviews drugs and their prices, said the evidence was incomplete.
    • “The FDA told its advisers that it is looking into allegations of study misconduct and missing side effects. It told the Journal that it can’t comment on investigations until they are final, but its findings will be incorporated into its decision on the Lykos treatment.
    • “Problems with the trials mean the FDA might not be able to assess whether the treatment is safe and effective for everyone, or just some people, said experts advising the agency and bioethicists who spoke to the Journal about its findings.”

From the public health and medical research front,

  • USA Today lets us know,
    • “The KP.3.1.1 COVID-19 variant is the dominant strain of the virus, the latest projections from the Centers for Disease Control and Prevention (CDC) show.
    • “The agency’s Nowcast data tracker, which displays COVID-19 estimates and projections for two-week periods, projects the KP.3.1.1 variant accounting for 27.8% of positive infections, followed by KP.3 at 20.1% in the two-week stretch starting July 21 and ending Aug. 3.
    • “The KP.3.1.1 variant is very similar to other circulating variants in the United States. All current lineages are descendants of JN.1, which emerged in late 2023,” Rosa Norman, a spokesperson at the CDC, previously told USA TODAY.
    • “At this time, we anticipate that COVID-19 treatments and vaccines will continue to work against all circulating variants. CDC will continue to monitor the severity of variants and will monitor vaccine effectiveness.”
  • Bloomberg reports,
    • “Some CVS Health Corp. pharmacies are selling out of at-home Covid tests as a summer surge in infections drives up demand.
    • “As of Friday afternoon [August 2], CVS’s website showed that all brands of tests were out of stock at many locations in cities including Houston, Austin and Reno, Nevada. 
    • “The company said that 91% of its stores have at least one brand of test in stock. While the company “has seen an uptick in purchases” of the tests, it’s “quickly sending product to impacted stores,” a spokesperson said in an email.”
  • Per MedPage Today,
    • “Intermittent calorie restriction improved executive function and memory measures in cognitively intact older adults, an exploratory pilot study suggested.
    • “The 8-week randomized clinical trial of 40 overweight, cognitively normal older adults with insulin resistance examined the effect of two interventions — a 5:2 intermittent fasting plan versus a “healthy living” diet based on portion control and calorie reduction guidelines from the U.S. Department of Agriculture — on brain health. The 5:2 intermittent fasting group had 2 days of food intake of 480 calories/day (two meal replacement shakes), and 5 days of a healthy living diet.
    • “Both interventions improved executive function and memory, with intermittent fasting showing better results on certain cognitive measures, said Dimitrios Kapogiannis, MD, of the National Institute on Aging (NIA) and the Johns Hopkins University School of Medicine in Baltimore, in a poster presented at the Alzheimer’s Association International Conference.” * * *
    • “Many people think that eating a healthy diet or following an intermittent fasting regimen are good ways to stave off cognitive decline during aging, but our study actually provided supporting evidence,” Kapogiannis told MedPage Today.
    • “Our study lays the groundwork for larger clinical trials that will examine a variety of dietary interventions that will help people have good brain health and live healthier, longer lives,” he said.”
  • Beckers Clinical Leadership informs us,
    • “More than half of patients hospitalized and treated for pneumonia receive differing diagnoses during their stays, according to a study published in Annals of Internal Medicine. 
    • “Researchers from the University of Utah Health and the nearby VA Healthcare System, both based in Salt Lake City, measured the rates of concordance and discordance in pneumonia diagnoses. They followed three states: initial diagnosis in the emergency department, initial chest image reports and discharge diagnosis. 
    • “Among more than 2 million admissions at VA hospitals across the U.S., 36% of patients were admitted with a pneumonia diagnosis but not a corresponding discharge diagnosis. Another 33% had a discharge diagnosis of pneumonia but not an admission diagnosis. The study focused on admissions between 2015 and 2022.” * * *
    • “In conclusion, the authors of the latest study said physicians and patients should be aware of this high level of uncertainty about pneumonia diagnoses.

From the U.S. healthcare business front,

  • The Peterson/KFF Health System Tracker considers what drives health spending in the U.S. compared to other countries.
    • “The United States spends significantly more on healthcare than comparable countries do, and yet has worse health outcomes. Much of the national conversation has focused on spending on retail prescription drugs and insurer profits and administrative costs as key drivers of health spending in the United States. The Inflation Reduction Act, signed into law by President Biden in 2022, includes several provisions aimed at lowering the cost of these prescription drugs. While it is true that many brand-name retail prescription drugs are priced higher in the U.S. than in peer countries, health spending data indicates that other spending categories – particularly hospital and physician payments – are primary drivers of the U.S.’s higher health spending.” 
  • Risk and Insurance points out,
    • “Only about half of U.S. employers effectively manage health care costs, with nearly all organizations experiencing health plan premium increases, according to Gallagher’s 2024 U.S. Physical & Emotional Wellbeing Report.
    • “The report, which surveyed 3,552 organizations, found that employers ranked the high costs of medical services (68%) and specialty drugs (44%) as their top health care cost management challenges.” * * *
    • “Access the report on Gallagher’s website.”
  • Per BioPharma Dive,
    • “All doses of tirzepatide, the drug Eli Lilly sells as Zepbound for obesity and Mounjaro for diabetes, are now available in the U.S. after months of shortages made the in-demand medicine hard to obtain.
    • “Two dose strengths of Zepbound and another two of Mounjaro had been listed in short supply on a database maintained by the Food and Drug Administration as recently as early last week, before the agency updated the drug’s status to available on Friday.
    • “Lilly reports second quarter earnings on Thursday, when sales and supply of tirzepatide are likely to be the main focus of analyst questions. The company in April raised its financial forecasts for the year by $2 billion due to revenue growth for Zepbound and Mounjaro, which together brought in $2.3 billion between January and March.”
  • Per Healthcare Dive,
    • “Walgreens has once again cut its stake in drug distributor Cencora as the struggling pharmacy chain looks to boost funding.
    • “The Illinois-based retailer announced last week it was selling more shares in Cencora for roughly $1.1 billion in proceeds. The sales lower Walgreens’ stake in Cencora to approximately 10% from 12%.
    • “Walgreens said it will use the money to pay down debt and to fund its operations as it continues to pivot to a health services strategy.”
  • Per MedTech Dive,
    • “Johnson & Johnson said Friday [August 2] it launched Velys Spine, a surgical robot and standalone navigation platform. 
    • “The 510(k)-cleared system, which J&J developed with eCential Robotics, is designed to provide guidance on the placement of screws in freehand and robotic-assisted spine surgeries. 
    • “J&J’s Depuy Synthes plans to make the system available commercially in the first half of 2025. The system will join other Velys offerings J&J has cited as a growth driver in its hip and knee businesses.”
  • Per Fierce Healthcare,
    • “Steward Health Care will lay off about 1,200 workers in Massachusetts by the end of the month as it moves to close two hospitals in the state.
    • “The health system will let go 753 employees at its Carney Hospital and 490 workers at its Nashoba Valley Medical Center, according to a Worker Adjustment and Retraining Notification (WARN) report filed with state regulators on July 29.
    • “On Thursday, a federal judge cleared the way for embattled Steward Health Care to close Carney Hospital and Nashoba Valley Medical Center by the end of August. Those are two of the eight hospitals that the health system operates in the Bay State.”
  • and
    • “For the first time as a public company, Clover Health is announcing its first quarterly net profit, the company said ahead of its second quarter earnings call.
    • “Clover declared a net income of $7.2 million and an adjusted EBITDA of $36.2 million, both figures a substantial improvement year-over-year.
    • “I am delighted that our performance continues to validate Clover’s differentiated, technology-centric approach to healthcare, driven by our insurance offering and its ability to generate meaningful returns while leading with physician-choice for our members,” said Clover Health CEO Andrew Toy in a statement. “Through our Clover Assistant technology and integrated care management platform, we aim to empower physicians to improve clinical outcomes and lower the total cost of care for people with chronic diseases. This allows us to partner with a much wider range of physicians than other plans.”
    • “Insurance revenue also soared 11% higher year-over-year to $349.9 million due to member retention and growth, whereas the company’s medical cost ratio (MCR) improved to 71.3%, down from 77.9% the quarter before.”
  • and
    • “Cigna unveiled the first round of grant winners in a program announced earlier this year that seeks to address the rising tide of mental health needs among youth.
    • “The funding will be distributed to 22 awardees, Cigna said on Monday. For close to half of the recipients, it’s the first time they’re securing funding from Cigna or its philanthropic arm, the Cigna Group Foundation, according to an announcement.
    • “Cigna said it will distribute $9 million as part of the program. The organizations will focus on tackling post-pandemic stress and distress among kids aged five to 18, according to the release. There will be a particular emphasis on outreach in schools or related settings, Cigna said.”