Midweek Update

CDC

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.”

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.”

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%. 

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.”

Friday Factoids

David Ermer–CDC, Congress, COVID-19, Mental health care, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Govexec reports,
    • “Lawmakers on the Senate Appropriations Committee unveiled and unanimously advanced spending legislation Thursday effectively endorsing President Biden’s planned 2% average pay increase for federal workers in January, to the chagrin of federal employee groups and advocates.
    • “The committee moved four of the 12 fiscal 2025 appropriations bills Thursday, including the Energy and Water Development; Defense; Labor, Health and Human Services; and Financial Services and General Government Appropriations acts. That last bill is traditionally the avenue by which lawmakers seek to override a president’s alternative pay plan, and the committee’s draft is silent on most federal workers’ compensation rates, effectively endorsing the White House’s plan.” * * *
    • “With the GOP-controlled House Appropriations Committee’s version of the Financial Services and General Government spending package, advanced by the panel last month on a party-line vote, similarly endorsing the White House proposal, it is unlikely federal employees will see a raise larger than 2% next year.”
  • Bloomberg Law lets us know,
    • “The Biden administration failed to persuade the Fifth Circuit to reinstate rules making median network rates a primary consideration in deciding payment disputes under a law meant to prevent “surprise” medical bills. 
    • “In a Friday ruling, the appeals court upheld a lower court decision in favor of health-care providers that had vacated the regulations implementing the No Surprises Act from the Departments of Health and Human Services, Labor, Treasury, and Office of Personnel Management.
    • “Judge Jeremy Kernodle of the US District Court for the Eastern District of Texas had ruled in 2022 that the agencies didn’t abide by the text of the health-care benefits statute in issuing requirements that arbitrators must follow in payment dispute cases between medical providers and health insurers.
    • “The US Court of Appeals for the Fifth Circuit panel’s decision agreeing that the regulations violate the Administrative Procedure Act creates another significant setback for the government in its attempt to defend the rules governing the arbitration system from a spate of litigation.” * * *
    • “The DOL, HHS, and Treasury Departments did not immediately respond to requests for comment on the decision Friday.”
  • The National Committee for Quality Assurance has released information on its measurement year 2025 HEDIS measures.
    • “For Measurement Year 2025, NCQA added three HEDIS measures, retired four measures and made smaller changes across multiple measures. We also continue the transition to Electronic Clinical Data Systems (ECDS) reporting.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration on Thursday approved a new type of cellular medicine, clearing a therapy developed by the biotechnology company Adaptimmune for a rare soft tissue cancer called synovial sarcoma.
    • “The agency granted Adaptimmune’s therapy, formerly known as afami-cel and to be sold as Tecelra, an accelerated approval for use in some people with metastatic synovial sarcoma who previously received chemotherapy. Those people must have certain immune signatures and tumors expressing a protein, MAGE-A4, that Tecelra is designed to target.
    • “The FDA based its decision on Tecelra’s ability to spur tumor responses in about 43% of people who received it in a clinical trial, with responses lasting a median of about 6 months, according to the therapy’s new labeling. Adaptimmune has to confirm those benefits in an ongoing study to maintain the approval. The company expects to submit those results next year, executives said on a Friday conference call with analysts.”

From the public health and medical research front,

  • The Centers for Disease Control informs 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. 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
  • Calculated Risk adds, “COVID in wastewater is increasing – especially in the West and South.” 
  • STAT News tells us,
    • “Untreated vision loss and high LDL cholesterol have been added as two new potentially modifiable risk factors for dementia in a report released Wednesday by the Lancet Commission.
    • “These new additions join 12 other risk factors outlined by the commission, affiliated with University College London, in previous reports on dementia prevention, intervention, and care in 2017 and 2020. The other risk factors are lack of education, hypertension, physical inactivity, diabetes, social isolation, excessive alcohol consumption, air pollution, smoking, obesity, traumatic brain injury, and depression.
    • “The commission’s latest findings suggest more ways of preventing dementia than previously known, according to Gill Livingston, a professor of psychiatry at University College London and co-author on the report.
    • “A lot of surveys have asked people of 50 and above what illnesses they most are concerned about, and dementia tends to come up as the highest one,” Livingston said. “And yet there’s really quite a lot that we can do to change the scales and make it less likely.”
  • Per Fierce Healthcare,
    • “CVS Health has launched an environmental health impact program to help vulnerable Americans during extreme weather events.
    • “The program, already live for a few weeks, initially focuses on extreme heat. Using advanced environmental data analytics and patients’ medical and pharmacy data, CVS Health offers timely excessive heat alerts and outreach to at-risk patients up to a week before the event. The initiative will expand to encompass air quality events this fall. It is initially available to members of Aetna with the goal of expanding to pharmacies and MinuteClinics.” * * *
    • “Heat waves and our changing environment is just such a pressing public health threat. I don’t think it’s appreciated nearly as much as it should be,” Dan Knecht, M.D., chief clinical innovation officer for CVS Caremark, told Fierce Healthcare.” * * *
    • “Consulting with experts in climate change and public health, CVS Health determined a wet bulb temperature threshold in the mid-80s Fahrenheit. Ingesting third-party weather data, it determines regions that surpass the limit and uses its own algorithm to stratify Aetna members by their vulnerability to extreme heat. Care managers who are registered nurses then reach out by phone, using an evidence-based framework for navigating the conversations. They provide information on the symptoms of heat stroke, how to minimize heat exhaustion and local resources such as cooling centers. Many Oak Street Health centers, now owned by CVS Health, can be used as a safe space to gather during extreme temperatures, Knecht said.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Contract disputes between hospitals and health plans have become routine, but they tend to be local, affecting a handful of hospitals and the people in the surrounding communities.
    • “This latest one is different. It involves the country’s biggest private health insurer, UnitedHealthcare, and its biggest hospital chain, HCA Healthcare. If they can’t strike a deal on prices by Sept. 1, 38 hospitals and their affiliated physician groups and surgery centers across four states — Texas, Colorado, South Carolina, and New Hampshire — would become out-of-network for UnitedHealthcare members. * * *
    • “UnitedHealthcare spokesperson Cole Manbeck said in a statement that HCA issued notices to end its contracts in four markets and demanded “significant price hikes that are not affordable or sustainable.” Manbeck said UnitedHealthcare shares the goal of reaching an agreement that ensures continued access to providers. He added that the parties could reach an agreement in one market and not another. “It’s not all or nothing,” he said.”
  • Per Healthcare Dive,
    • “Private equity firms TowerBrook Capital Partners and Clayton, Dubilier and Rice entered into a definitive agreement to acquire R1 RCM for about $8.9 billion and take the company private, the revenue cycle management firm said Thursday. 
    • “TowerBrook currently controls around 36% of the company’s shares, according to a press release. Under the deal, which will take R1 private, TowerBrook and CD&R will buy the rest of the company’s outstanding stock for $14.30 per share.
    • “The acquisition comes months after another private equity firm, New Mountain Capital, offered to buy out other investors for $13.75 a share— a price some analysts thought undervalued R1.” 
  • and
    • “Amwell boosted its adjusted earnings outlook for 2024 as the telehealth vendor works to cut costs and rein in expenses.
    • “The company now expects adjusted earnings before interest, taxes, depreciation and amortization to be a loss between $150 million and $145 million. It previously estimated adjusted EBITDA losses between $160 million and $155 million.
    • “Amwell also narrowed its net loss in the second quarter. The virtual care vendor reported a loss of $49.9 million, compared with $92.5 million during the same period last year.”




Tuesday Tidbits

David Ermer–CDC, CMS, Medical / Rx research, Medicare, Mental health care, NIH, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Fierce Healthcare reports,
    • “The Centers for Medicare & Medicaid Services (CMS) is creating a voluntary demonstration program to support changes to Medicare Part D under the Inflation Reduction Act (IRA).
    • “The agency also finalized bid information for contract year 2025, with a base beneficiary premium increase of $2.08 for people with Part D.
    • “The IRA is designed to limit yearly premium increases from contract year 2024 to 2029. Because Part D and prescription drug plans can result in plan price variation for beneficiaries, CMS is creating the Part D Premium Stabilization Demonstration to “improve premium stability for participating stand-alone prescription drug plans,” according to a news release.
    • “This should result in a smoother rollout in how the IRA requires Medicare to support Part D prescription plans. The program will test whether even more financial requirements would improve the Part D program, a senior CMS official said Monday afternoon.”
  • Here is the link to the CMS fact sheet for the Part D demonstration project and bid information.
  • American Hospital Association News lets us know,
    • “The Centers for Medicare & Medicaid Services July 30 issued a final rule updating hospice payment rates for fiscal year 2025. Overall, CMS finalized a 2.9% net increase to payments compared with FY 2024. This includes a 3.4% market basket update and a 0.5 percentage point cut for productivity. As a result of this increase, the hospice payment cap will be increased from $33,494.01 to $34,465.34. CMS also finalized adoption of the most recent Office of Management and Budget statistical area delineations, which will affect the wage index used by some providers. In addition, the rule adopts a new patient-level data collection tool to replace the existing Hospice Item Set and also adds two new process measures beginning in FY 2028.”
  • Here is a link to the CMS fact sheet on the hospice payment rates.
  • The Washington Post informs us,
    • “The Centers for Disease Control and Prevention is launching a $5 million initiative to provide seasonal flu shots this fall to about 200,000 livestock workers in states hardest hit by the bird flu outbreak.
    • “Workers on poultry, dairy and pig farms are at greatest risk of being simultaneously exposed to seasonal flu and the H5N1 bird flu that has infected at least 172 dairy herds in 13 states, according to the Department of Agriculture. Such exposures raise the rare risk of the two viruses exchanging genetic material, a process known as reassortment, to create a new influenza virus that “could pose a significant public health concern by becoming more efficient at spread and potentially more severe,” Nirav Shah, CDC’s principal deputy director, said at a news briefing Tuesday. Widespread seasonal flu vaccination would reduce that risk, he said.
    • “Thirteen farmworkers have been infected in the outbreak. All had mild symptoms and recovered.
  • Per an HHS press release,
    • Today, the U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) released the results of the 2023 National Survey on Drug Use and Health (NSDUH), which shows how people living in United States reported their experience with mental health conditions, substance use and pursuit of treatment. The 2023 NSDUH report includes selected estimates by race, ethnicity and age group. The report is accompanied by two infographics offering visually packaged highlight data as well as visual data by race and ethnicity.
  • The press release includes key findings from the survey.
  • MedTech Dive tells us about how a “[p]atient shares a day in the life with diabetes at FDA’s first Home Health Hub meeting. The initiative, led by new CDRH Acting Director Michelle Tarver, is intended to improve health equity by including people’s living conditions in device design.”
  • The Assistant Secretary of Labor for Employee Benefit Security seeks in her blog to “raise awareness and break the silence surrounding minority mental health.
  • HHS’s Office for Civil Rights amended its Change Healthcare Cybersecurity Incident FAQ three to read as follows:
    • “3. Have Change Healthcare or UHG filed a breach report with HHS?
    • “A: Yes, on July 19, 2024, Change Healthcare filed a breach report with OCR concerning a ransomware attack that resulted in a breach of protected health information. Change Healthcare’s breach report to OCR identifies 500 individuals as the “approximate number of individuals affected”. This is the minimum number of individuals affected that results in a posting of a breach on the HHS Breach Portal. Change Healthcare is still determining the number of individuals affected. The posting on the HHS Breach Portal will be amended if Change Healthcare updates the total number of individuals affected by this breach. HIPAA breach reports filed on the HHS Breach Portal may be amended as the breach report form allows a filer to file an initial breach report or an addendum to a previous report.”
  • Per a press release from the U.S. Attorney for the District of Massachusetts,
    • “Burlington County Eye Physicians (BCEP), an ophthalmology practice with locations in New Jersey and Pennsylvania, and Dr. Gregory H. Scimeca, an ophthalmologist and the owner of BCEP, have agreed to pay $469,232 to resolve allegations that they submitted and caused the submission of false claims for payment for medically unnecessary transcranial doppler (TCD) tests to Medicare and the Federal Employee Health Benefit (FEHB) Program in violation of the False Claims Act. 
    • “A TCD test is a noninvasive diagnostic test that can be used to estimate the blood flow through certain blood vessels in the brain. Medicare and the FEHB Program reimburse healthcare providers for both performing the test and for interpreting the test results. When a physician does not perform the test, but interprets the results of the test, they only can bill for their professional services of interpreting the test. A physician cannot bill for interpreting the test when they merely review another physician’s interpretation of the results.”  

From the public health and medical research front,

  • The Washington Post reports,
    • “The suicide rate for U.S. children 8 to 12 years old has steadily climbed in the past decade and a half, with a disproportionate rise among girls, data released Tuesday by the National Institute of Mental Health shows.
    • “The findings, published in the journal JAMA Network Open, highlight pervasive issues regarding mental health that affect U.S. children daily, the study authors said.
    • “The authors of the study blame no single reason for the increase, but experts not involved in the study say the problem is multifaceted, citing technology, social media and guns as the main culprits.
    • “Between 2001 and 2022, 2,241 children ages 8 to 12 — known as preteens — died by suicide. While suicide rates were decreasing until 2007, they increased by about 8 percent each year from 2008 to 2022.
    • “From 2001 through 2007, 482 children ages 8 to 12 died by suicide at a rate of 3.34 per 1 million “preteens. From 2008 to 2022, the number of suicides in that age group rose to 1,759, with a rate of 5.71 per 1 million.”
  • Per STAT News,
    • “If millions of Americans no longer qualify for a statin or a blood pressure medication based on a new calculator updated to better predict their risk, that could lead to 107,000 more heart attacks and strokes over 10 years, a new study estimates.
    • “The research paper, published Monday in JAMA, is the second in two months drawing attention to widely used medicines designed to prevent the leading cause of death in the United States.
    • “The research is creating a buzz in cardiology circles while two medical societies formulate new guidelines to inform practice, weighing the new risk models and existing thresholds that trigger prescriptions.
    • “This is concerning that we could reverse eligibility for many millions of Americans,” Raj Manrai, assistant professor of biomedical informatics in the Blavatnik Institute at Harvard Medical School and senior author of the new study, said in an interview. “We really need to reexamine the other side of the equation here, which is how those risk estimates are going to be used by patients and physicians to decide who and when individuals receive preventative care, particularly statins and antihypertensive blood pressure medications.”
  • Per a National Institutes of Health (NIH) press release,
    • “A new global study sponsored by the National Institute of Allergy and Infectious Diseases has determined that cabotegravir, an antiretroviral medication used for HIV treatment, is safe for use before and during pregnancy. The study analyzed the pregnancy and infant outcomes of using long-acting injectable cabotegravir in more than 300 pregnant women. These findings fill an important knowledge gap that will help increase access to HIV treatment for cisgender women before, during, and after pregnancy.” 
  • NIH also posted a summary of recent medical research developments.
  • STAT News relates,
    • “A new study suggests that an older GLP-1 drug may help protect the brains of people with early Alzheimer’s disease, supporting the case for further research on the class of medications — originally developed for obesity and diabetes — in neurological diseases.
    • “The Phase 2 randomized trial, led by researchers at Imperial College London, tested Novo Nordisk’s liraglutide, the predecessor to Ozempic and Wegovy, in patients with early Alzheimer’s disease over one year. The study did not meet the primary endpoint of change on a measure of how much sugar the brain uses for energy, but it showed that patients on the drug had nearly 50% less shrinking in parts of the brain that control memory and learning and that treated participants had a slightly slower decline in cognitive function.”
  • CNN adds,
    • “A growing set of evidence suggests that using semaglutide could lead to decreased substance use, and a large new study shows a promising link between the medication and tobacco use. But experts emphasize that much more research is needed before using the medications off-label for smoking cessation.
    • “In a study published Monday in the journal Annals of Internal Medicine, researchers tracked the medical records of more than 200,000 people who started medications to treat type 2 diabetes, including nearly 6,000 people using semaglutide medications such as Ozempic.
    • “Over the course of a year, people who started using semaglutide were significantly less likely to have medical encounters for tobacco use disorders, prescriptions for medications for smoking cessation or counseling for smoking cessation than those who started other diabetes medications such as insulin and metformin.
    • “The study authors note that the reasons individuals might be less likely to seek medical treatment for tobacco use disorder vary widely; it could suggest that their tobacco use decreased or that they’ve become less willing to seek help to quit smoking, for example.”

From the U.S. healthcare business front,

  • Reuters points out,
    • “Four pharmaceutical companies involved in the first U.S. negotiations over prices for the Medicare program said they do not expect a significant impact on their businesses after seeing confidential suggested prices from the government for their drugs that will take effect in 2026.
    • “Top executives from Bristol Myers Squibb (BMY.N), opens new tab, Johnson & Johnson (JNJ.N), AbbVie (ABBV.N), and AstraZeneca (AZN.L), which have five of the 10 drugs chosen for the first wave of negotiations, described their newly informed views on quarterly conference calls.”
  • Modern Healthcare notes,
    • “Drug prices are expected to increase 3.81% next year, propelled by expensive cell and gene therapies and glucagon-like peptide agonists.
    • “The estimate from Vizient, a group purchasing organization, tops the company’s 2024 drug cost growth projection of 3.42%. Vizient uses recent provider purchasing data to forecast what hospitals and health systems might pay for drugs after discounts and rebates.”
  • The Wall Street Journal reports,
    • “Pfizer’s quarterly results beat Wall Street estimates and the drugmaker raised its outlook, denoting strong demand for its non-Covid products. * * *
    • “Pfizer’s revenue was boosted by several acquired products and recent commercial launches, which offset a decline from its Covid-19 vaccine Comirnaty, and unfavorable foreign currency translation. Excluding Covid products, revenue rose 14% on the year.
    • “Chief Financial Officer David Denton said this was the first quarter of top-line growth since the end of 2022, when Pfizer’s Covid-related revenues peaked.
    • “Pfizer Chief Executive Albert Bourla said in an interview the company is making progress on its strategy to drive growth and improve the company’s share price through dealmaking, including its $43 billion acquisition of cancer-maker; cost-cutting programs; and launching new medicines.
    • “We are progressing on all cylinders,” he said.”
  • Per STAT News,
    • “Shares of Merck fell 9% Tuesday after the company reported that in the second quarter, it saw a decrease in shipments of its HPV vaccine Gardasil in China, a significant market for the drug.
    • “The company brought in $2.48 billion in sales of Gardasil in the second quarter, slightly lower than estimates of $2.5 billion made by analysts polled by Visible Alpha.
    • “Despite the Gardasil hit, Merck raised guidance for full-year sales to $63.4 to $64.4 billion from the previously guided $63.1 to $64.3 billion. The company lowered guidance for full-year earnings, though, to $7.94 to $8.04 per share from the previously forecasted $8.53 to $8.65, due to expenses related to the acquisition of ophthalmology-focused biotech EyeBio.”
  • Per Healthcare Dive,
    • “Google will not renew its contract with Amazon’s primary care subsidiary One Medical, ending a longstanding agreement that gave Google employees access to discounted medical care, the companies confirmed to Healthcare Dive.
    • “The contract loss is a major blow for the provider. Google was One Medical’s largest customer, accounting for 10% of its revenue in 2020. That figure dipped slightly in 2021, after which One Medical stopped disclosing its finances publicly.
    • “The decision is not because One Medical was acquired by Google rival Amazon last year, a Google spokesperson said. The current contract will expire at the end of 2024.”
  • and
    • “Mental telehealth coverage has contracted slightly since the government declared an end to the COVID-19 public health emergency last year, according to a new study published in JAMA.
    • “The study, which analyzed over 1,000 outpatient mental health treatment facilities, found that publicly owned mental health treatment facilities were less likely to have adopted telehealth services at all, and more likely to have discontinued them after the Biden administration ended the COVID PHE, compared to privately owned facilities.
    • “The results come as lawmakers are considering whether to permanently expand telehealth flexibilities to providers this year, after the federal government enacted temporary policies that expanded access to telehealth services during the pandemic.”
  • The Washington Post gives us a heads up on the test run of drones to deliver cardiac care to patients in North Carolina.
    • “What if the first responder on the scene of a cardiac arrest were a drone carrying an automated external defibrillator?
    • “When every second counts, public safety professionals are increasingly eyeing drones — which can fly 60 miles an hour and don’t get stuck in traffic — to deliver help faster than an ambulance or EMT.
    • “Starting in September, 911 callers in Clemmons, N.C., may see a drone winging its way to those suffering a cardiac arrest. Under a pilot program operated jointly by the Forsyth County Sheriff’s Office, local emergency services, the Clinical Research Institute at Duke University and drone consulting firm Hovecon, drone pilots from the sheriff’s department will monitor 911 calls and dispatch drones.”
  • The Wall Street Journal lets us know,
    • “Theranos’s ambitions for a finger-prick blood test are finally being realized—by other companies.
    • “”Since May, needle-phobic people in Austin, Texas, have been able to visit pharmacies for routine medical tests on drops of blood squeezed from their fingertips, rather than the usual way of plunging a needle into a vein in the arm and drawing large vials of blood. 
    • The rise and fall of Theranos—the Silicon Valley startup that promised to revolutionize blood testing but ended dissolved, with its founder Elizabeth Holmes convicted of fraud—cast a pall over the idea that critical medical tests could be run on mere drops of blood.
    • “Demand for alternatives to standard blood draws never went away, however. And companies—including Becton Dickinson and Babson Diagnostics, which make the tests rolling out in Austin—have been working out technological kinks that foiled Theranos.”
    • FEHBlog observation: As the old saying goes, timing is everything.


Monday Roundup

David Ermer–CDC, Medicare, Mental health care, Obesity, OPM, SCOTUS, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • Kiplinger Private Finance reminds us,
    • “Beginning in 2025, people with Part D plans won’t have to pay more than $2,000 in out-of-pocket costs, thanks to a provision in the Inflation Reduction Act of 2022. The $2,000 cap will be indexed to the growth in per capita Part D costs, so it may rise each year after 2025. Part D enrollees will also have the option of spreading out their out-of-pocket costs over the year rather than face high out-of-pocket costs in any given month.”
  • The Part D EGWP benefit package is so generous for 2025 that it should sell itself. Given this juicy carrot, there is no reason why OPM chose to resort to the stick – prohibiting Part D EGBP opt outs from receiving the regular PSHBP prescription drug benefits. Hopefully, OPM will switch back to the carrot in the final PSHBP supplemental rule.
  • Govexec points out,
    • “Only 7% of the full-time civil service was under the age of 30 at the end of fiscal 2022 compared with 20% of the overall U.S. labor force, according to the Partnership. This shaky pipeline of young workers could exacerbate staffing shortages, as a 2022 White House document concluded that 30% of the federal workforce would be eligible to retire over the next five years.
    • “The underrepresentation also means that federal agencies could miss out on younger perspectives and talent, particularly from Generation Z (individuals born in the late ‘90s and early ‘00s). Gaurav Gupta — managing director of the consulting firm Kotter, which researches workforce transformation — argues that workplaces could greatly benefit from younger workers who have a “much higher propensity for change.” 
    • The article discusses approaches for attracting more Gen Zers to federal government service.
  • MedTech Dive reports,
    • “The Food and Drug Administration has approved Guardant Health’s Shield blood test as a primary screening option for colorectal cancer in average-risk adults age 45 and older, the company said Monday.
    • “Guardant is positioning the test, which can be completed during a routine doctor visit, as a more pleasant and convenient alternative to colonoscopy or stool-based tests that will encourage more people to undergo colorectal cancer screening.
    • “Shield can address a number of unscreened individuals (with a blood draw) for those not willing or unable to perform a colonoscopy or take a stool test,” Leerink Partners analyst Puneet Souda wrote in a report to clients. Still, Souda expects colonoscopy to remain the first-line screening choice of physicians based on clinical evidence, followed by Exact Sciences’ Cologuard stool test.”
  • Supreme Court journalist Amy L. Howe shares the Supreme Court’s October and November 2023 oral argument calendars. None of the scheduled cases directly impacts health plans as such.

From the public health and medical research front,

  • NBC News reports,
    • “The number of measles cases recorded this year is more than triple the total from all of last year — with five months still to go.
    • “According to data released Friday by the Centers for Disease Control and Prevention, 188 cases have been reported in 26 states and Washington, D.C. No deaths have been reported, but 93 people have been hospitalized — mostly children under 5 years old.
    • “The U.S. has seen 13 measles outbreaks this year, the largest of which took off at a migrant shelter in Chicago in March and was linked to more than 60 cases.
    • “This month, measles cases have been reported in Massachusetts, Michigan, Minnesota, New Hampshire, New York, Oregon and Vermont. Massachusetts’ case was the first in the state since early 2020.” * * *
    • “Experts attribute this year’s uptick to two main factors: declining vaccination rates in the U.S. and a rise in measles cases worldwide.
    • “Around 85% of the people who got measles this year were either unvaccinated or had an unknown vaccination status, according to the CDC. Many of the cases have been linked to international travel, meaning the disease was brought into the U.S. by travelers who were infected in other countries.”
  • STAT News tells us,
    • “With the number of U.S. dairy herds infected with H5N1 bird flu rising almost daily, fears are growing that the dangerous virus cannot be driven out of this species. That belief is amplifying calls for the development of flu shots for cows.
    • “Multiple animal vaccine manufacturers are reportedly at work trying to develop such products. And the U.S. Department of Agriculture is eagerly encouraging the effort, detailing in a notice last week what kinds of evidence would be needed to win licensing approval for cow vaccines.
    • “But a number of scientists question whether investing too heavily in this strategy is a wise approach at this point, given that there remain many outstanding questions about whether vaccinating cows would be an effective way of stopping spread of the virus in cattle in the first place. Some wonder whether farmers will be willing to absorb the costs of vaccines to prevent an infection they don’t currently view as a serious threat to their operations, or whether they would agree to the stringent post-vaccination surveillance that must go hand-in-glove with any attempt to use vaccines to solve this vexing problem.” * * *
    • “David Swayne, an avian influenza expert who worked for the USDA for nearly 30 years and is now a private consultant, agreed that vaccination of cows would have to be done as part of a more multifaceted response. “It’s not just about injecting a vaccine,” he said. “You need to then follow up to look serologically, and then you also need to follow up to make sure there’s no virus by testing, let’s say, bulk milk or something like that. Surveillance is really a critical part of any kind of vaccination program for a severe disease like [highly pathogenic avian influenza.]”
    • “Swayne acknowledged the concerns about the unanswered questions about how H5N1 is spreading in cows, but he said vaccine manufacturers should be working on vaccines while researchers are seeking those answers. Vaccines may be a necessary tool for controlling this disease in the future. “Instead of waiting until you answer all the questions on pathogenesis, it’s good to go ahead and start working on those vaccines now, so that when you get to the end, and you have all your answers, you’ve got the vaccines ready for that final step,” he said.”
  • Beckers Hospital Review lets us know,
    • “The FDA is warning healthcare providers of dosing errors associated with compounded versions of semaglutide, the active ingredient in Ozempic, Rybelsus and Wegovy.
    • “The agency has received reports of hospitalizations and adverse events tied to the issue, including gastrointestinal issues, fainting, headache, dehydration and acute pancreatitis, according to a July 26 update. 
    • “Most adverse events occurred when patients self-administered incorrect doses of weight loss drugs from multiple-dose vials, sometimes taking five to 20 times the intended amount. Several reports also involved clinicians miscalculating doses, resulting in patients receiving five to 10 times more than the intended dose. 
    • “The agency said patients’ inexperience with self-injections and confusion over different measurement units may have contributed to the errors. 
    • “FDA encourages health care providers and compounders to provide patients with the appropriate syringe size for the intended dose and counsel patients on how to measure the intended dose using the syringe,” the agency said in the update. “Additionally, health care providers should be vigilant when prescribing and administering compounded semaglutide, as there may be different concentrations available.”
    • “Learn more here.”
  • At this link, “KFF Examines the Latest Data on Calls, Texts, and Chats to the 988 National Suicide and Crisis Hotline, Two Years After Its Launch.” 

From the U.S. healthcare business front,

  • Per its website,
    • “”Community Health Systems (CHS) operates 71 acute-care hospitals and more than 1,000 other sites of care, including physician practices, urgent care centers, freestanding emergency departments, occupational medicine clinics, imaging centers, cancer centers and ambulatory surgery centers.”
  • Healthcare Dive adds,
    • “Community Health Systems grew same-store surgical volumes and outpatient volumes in the second quarter, helping the Franklin, Tennessee-based system trim losses for the second consecutive quarter. However, the system still posted a net loss of $13 million for the quarter.
    • “CHS attributed its improved financial position to an early “extinguishment” of debt, reduced expenses for contract labor and increased reimbursement rates.
    • “On an earnings call Thursday, CEO Tim Hingtgen said the results speak to CHS’ solid fundamentals, and said he believes the company can continue to improve in subsequent quarters. CHS raised the midpoint of its full-year EBITDA guidance by $10 million in light of the results.”
  • Per BioPharma Dive,
    • “An experimental heart drug from biotechnology company NewAmsterdam Pharma met its main goal in the first of several Phase 3 trials, but the results fell short of investor and analyst expectations.
    • “In the trial, people with an inherited condition called heterozygous familial hypercholesterolemia who received the drug alongside other medicines saw their levels of LDL, or “bad,” cholesterol fall by 36% after three months, when adjusted for placebo, and by 41% after one year. The drug, obicetrapib, reduced other markers of heart disease while its safety was “comparable to placebo,” the company said.
    • “On a conference call, NewAmsterdam CEO Michael Davidson said the results raise the company’s confidence in other ongoing studies. But shares fell by as much as one-third in premarket trading before opening down 4% Monday morning, as investors had anticipated more powerful cholesterol-lowering effects.”
  • American Hospital Association News points out,
    • “A fact sheet released July 29 by the Coalition to Strengthen America’s Healthcare features analysis from KNG Health Consulting that shows nearly half of all hospital emergency department visits occur after-hours (between 5 p.m. and 8 a.m.), when patient care options are limited. The analysis found that children are particularly more likely to receive care at an ED outside of normal business hours. It also found that of the 136 million ED visits in 2021, 18.1 million were in rural areas, and that 34.3 million visits that year were trauma related. The AHA is a founding member of the Coalition.”
  • That means over 100 million of the ED visits were not trauma related. What’s up with that?
  • Per Fierce Pharma,
    • “A month after a CDC panel narrowed its recommendations for who should receive vaccines to protect against respiratory syncytial virus (RSV), Airfinity has put numbers to the impact, reducing the projected market value in the United States by 64% by the end of the decade.
    • “The London-based healthcare analytics company has sliced the RSV market value for seniors in the US from $4.7 billion to $1.7 billion in 2030.” * * *
    • “Much still has to be decided related to RSV vaccines. Airfinity pointed out that “future dosing recommendations could change as long-term efficacy and safety data emerge.” With recommendations for a booster every two to three years, the U.S. market could increase in annual value to between $5.2 billion and $6.6 billion, Airfinity projects.”
  • The Washington Post reports,
    • “Almost half the counties in the United States lack a single cardiologist, according to a new study that puts the decades-long rural health-care crisis into sharp relief.
    • “Researchers at Brigham and Women’s Hospital in Boston looked at all 3,143 U.S. counties and found that just over 46 percent had no cardiologist, a finding senior author Haider J. Warraich called “truly shocking.”
    • “Compounding the problem, researchers discovered that risk factors for cardiovascular disease such as smoking, diabetes, obesity and high blood pressure “were actually more prevalent in the counties that did not have a cardiologist,” said Warraich, who spent several months in 2019 moonlighting as the only cardiologist in rural Randolph County, N.C.” * * *
    • “Alexander Razavi, a cardiology fellow at Emory University School of Medicine in Atlanta, said cardiologists may need to look beyond telemedicine to additional measures to reach rural communities. Cardiology practices that serve these areas, he said, might consider extending their hours or creating mobile examination units.
    • “We need to invest and provide resources to these communities,” Razavi said.”
  • Consumer Reports, writing in the Washington Post, lets us know how to know if claims made by health products are real or just hype. Check it out.


Friday Factoids

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

From Washington, DC,

  • Medical Economics alerts us,
    • “The hot seat in Washington, D.C., could get hotter for pharmacy benefit managers (PBMs) when the Federal Trade Commission (FTC) meets next week to discuss its recent report on the drug price middlemen.
    • “Meanwhile, a consortium of pharmacy groups is demanding federal lawmakers pass reforms they say are needed to regain control of the pharmaceutical market. A PBM trade group countered that legislators need a balanced and accurate discussion, not just repetition of claims of Big Pharma, which stands to benefit if PBMs lose their price bargaining power.
    • “As public discourse about PBMs at times rises to a clamor, the FTC announced its Aug. 1 open meeting will include a presentation on the Commission’s Interim Report on Pharmacy Benefit Managers (PBMs).”
  • FEHBlog note — PBMs do a more than negotiate prices with drug manufacturers and wholesalers. For example, PBMs also seamlessly process drug claims for consumers.  
  • Beckers Hospital CFO Report tells us,
    • “The U.S. economy saw a 2.8% increase in gross domestic product in the second quarter of 2024, reflecting a spike in consumer spending, nonresidential fixed investment and private inventory investment. 
    • “The first quarter saw GDP grow only 1.4%, according to the Bureau of Economic Analysis.
    • “Consumer spending also increased in goods and services. Healthcare, utilities, recreation services, and housing led service contributors. Motor vehicles and parts, furnishing and durable household equipment, gasoline and recreational goods led goods contributors.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention (“CDC”) announced today,
    • “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. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations are increasing, 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 CIDRAP adds,
    • “Nationally, wastewater detections of SARS-CoV-2 have been at the high level over the past few weeks, with the highest levels in Western states over the summer months. However, the CDC’s latest data show though detections in the West are still the highest in the nation, the level declined in the most recent reporting week.
    • “Wastewater detections are still rising steadily in the South. In the Midwest and Northeast, detections are still increasing, but at a slower pace.”
  • STAT News points out,
    • “The number of confirmed human infections with the bird flu virus associated with the ongoing outbreak in dairy cattle has risen to 13, the Centers for Disease Control and Prevention announced Thursday, as it confirmed three additional cases in Colorado. They are currently designated simply as H5 and not H5N1 because CDC labs are still working on typing the neuraminidase, the N number in the virus’ name, STAT’s Helen Branswell reports.
    • “The cases — one of which Colorado had previously announced as a “presumptive positive” — are in people who were culling infected poultry on a farm in the state. Genetic analysis of the virus in that poultry outbreak shows that it is similar to the virus circulating in cows; it’s believed this is one of several instances where H5N1 in cow herds has spilled over into nearby poultry operations. Of the 13 human cases, 10 have been detected in Colorado, which also has the highest number of reported infected dairy herds — 51, according to the state’s Department of Agriculture. Michigan and Texas have reported two and one human case, respectively.”
  • The Detroit Free Press reports,
    • “Liverwurst and several other deli meat products produced by Boar’s Head Provisions Co., Inc., based in Jarratt, Virginia, are being recalled because they may be contaminated with the Listeria monocytogenes bacteria, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) on Friday announced.
    • “Additional deli meat products produced on the same line and same day as the liverwurst are also being recalled because of potential listeria contamination.
    • “In total, more than 207,000 pounds of products are being recalled.
    • “The FSIS is concerned because some products may be in consumers’ refrigerators and in retail deli cases.”
  • MedPage Today discusses issues with the CDC’s bird flu virus vaccine.
  • Mercer Consulting explains why GLP-1 drug dislocation calls for a holistic approach to weight-loss.
  • U.S. News and World Report informs us,
    • “Cancer growth can be fueled by flecks of ancient viral DNA lodged into the genetics of modern humans, a new study says.
    • “Overall, about 8% of the human genome is made of bits of DNA left behind by viruses that infected our primate ancestors, researchers say.
    • “Called “endogenous retroviruses,” these DNA fragments have long been considered harmless junk littering the modern human genetic profile, researchers said.
    • “But new research shows that when reawakened, these ancient viral strands can help cancer survive and thrive, researchers reported July 17 in the journal Science Advances.
    • “What’s more, shutting up these viral voices from the past can make cancer treatments more effective, researchers found.
    • “Our study shows that diseases today can be significantly influenced by these ancient viral infections that until recently very few researchers were paying attention to,” said senior researcher Edward Chuong. He’s an assistant professor of molecular, cellular and developmental biology at the University of Colorado, Boulder’s BioFrontiers Institute.”

From the U.S. healthcare business front,

  • The Wall Street Journal looks at the drug shortage problem from the perspective of a courageous American who invested in a failing Amoxicillin plant located in Bristol, TN.
    • “A cavernous factory in northeastern Tennessee, by the Virginia border, is one of the last in the country that makes a vitally important medicine.
    • “Each day the USAntibiotics plant churns out a million doses of the crucial antibiotic amoxicillin that promise to cure Americans of everything from earaches to pneumonia—and ease a pressing shortage for children.
    • “But the plant’s prospects are dim. It can’t charge enough to cover overhead, because competitors sell their wares at bargain prices. USAntibiotics isn’t close to breaking even.
    • “It’s not for lack of trying,” said Rick Jackson, a health-staffing businessman who rescued the factory from near bankruptcy two years ago and has poured more than $38 million into purchasing and refurbishing it.
    • “The generic drug business has become a hostile environment for American companies. Prices for the often-critical medicines have dropped so low that it has become difficult for U.S. manufacturers to compete with companies overseas.”  * * *
    • “Jackson is holding out hope the federal government will help the plant. But if it doesn’t in the next year and a half, he said would shut the factory down.
    • “It’s not a failure yet,” Jackson said. “If there is a way to do it, we’ll figure it out.”
    • FEHBlog note – Hopefully the front-page WSJ article will help generate outside investment.
  • Per BioPharma Dive,
    • “Bristol Myers Squibb on Friday raised its forecast for revenue and profit per share this year after a second quarter in which sales of its older products and new drugs surpassed analyst expectations.
    • “The “beat and raise” followed similarly strong earnings reports this week from AstraZeneca, Roche, Sanofi and AbbVie, all of which upped either their revenue or profit estimates for 2024. Shares in Bristol Myers rose by nearly 9% in Friday morning trading on the news.
    • “Between April and June, Bristol Myers reported earning $12.2 billion in sales, 6% higher than Wall Street consensus forecasts. Second quarter earnings per share were $2.07 on an adjusted basis, 27% higher than estimated, according to Leerink Partners analysts.”Researchers have developed artificial blood vessels that could be as strong and durable as the real things, publishing their work in Advanced Materials Technologies.[1] The group hopes its work could go on to make a significant impact in care for heart bypass patients.
    • A team with the University of Edinburgh developed the synthetic vessels using 3D-printing technology. First, a “rotating spindle integrated into a 3D printer” was used to print grafts out of a water-based gel. Those grafts are then coated in biodegradable polyester molecules. 
    • If these “strong, flexible, gel-like tubes” can gain enough momentum among healthcare providers, lead author Faraz Fazal, PhD, and colleagues think many of the complications associated with removing human veins during bypass operations could be avoided altogether. 
    • “Our hybrid technique opens up new and exciting possibilities for the fabrication of tubular constructs in tissue engineering,” Fazal said in a statement. 
    • “The results from our research address a long-standing challenge in the field of vascular tissue engineering – to produce a conduit that has similar biomechanical properties to that of human veins,” added co-author Norbert Radacsi, PhD.
  • Cardiovascular Business reports,
    • “Researchers have developed artificial blood vessels that could be as strong and durable as the real things, publishing their work in Advanced Materials Technologies. The group hopes its work could go on to make a significant impact in care for heart bypass patients.
    • “A team with the University of Edinburgh developed the synthetic vessels using 3D-printing technology. First, a “rotating spindle integrated into a 3D printer” was used to print grafts out of a water-based gel. Those grafts are then coated in biodegradable polyester molecules. 
    • “If these “strong, flexible, gel-like tubes” can gain enough momentum among healthcare providers, lead author Faraz Fazal, PhD, and colleagues think many of the complications associated with removing human veins during bypass operations could be avoided altogether. 
    • “Our hybrid technique opens up new and exciting possibilities for the fabrication of tubular constructs in tissue engineering,” Fazal said in a statement. 
    • “The results from our research address a long-standing challenge in the field of vascular tissue engineering – to produce a conduit that has similar biomechanical properties to that of human veins,” added co-author Norbert Radacsi, PhD.”
    • FEHBlog note: Bravo.