Midweek Update

U.S. Healthcare

Midweek Update

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

From Washington, DC,

  • The Washington Post reports,
    • “The White House on Wednesday backed proposals to permanently stiffen penalties on synthetic-drug traffickers, monitor machines used to make fentanyl pills and close a loophole that allows criminal groups to easily ship drugs in packages.
    • “President Biden announced the initiatives as state and federal officials from both political parties grapple with how to curb a drug epidemic that has killed more than 300,000 people during his administration.
    • “The crisis is fueled by fentanyl, the potent synthetic opioid manufactured by Mexican criminal groups and smuggled into the United States. Border security has proved to be a political flash point, with Republicans hammering the White House about the failure to stop fentanyl from entering the country.”
  • American Hospital News informs us,
    • “At a Capitol Hill briefing July 31, hospital and health care leaders shared strategies and stories highlighting the importance of passing the Safety from Violence for Healthcare Employees Act (H.R. 2584/S. 2768), bipartisan legislation that would provide federal protections against violence to hospital workers.  
    • “The panel featured: Mark Boucot, president and CEO of Potomac Valley Hospital in Keyser, W.Va., and Garrett Regional Medical Center in Oakland, Md.; Rachel Culpepper, DNP, RN, general medicine service line director at Indiana University Health West Hospital in Avon, Ind.; and James Phillips, M.D., an emergency room physician in Washington, D.C. and chair of disaster medicine at the American College of Emergency Physicians. Sen. Joe Manchin, I-W.Va., author of the Senate bill, also delivered remarks.  
  • and
    • “The Centers for Medicare & Medicaid Services July 31 issued a final rule for fiscal year 2025 for the skilled nursing facility prospective payment system, which will increase aggregate Medicare spending by 4.2% or $1.4 billion compared to FY 2024. This reflects a 3% market basket update, a 1.7 percentage-point increase to counter the agency’s market basket error in FY 2023, and a 0.5 percentage point cut for productivity. CMS also revised its regulations regarding its nursing home enforcement authority to allow the agency to impose additional financial penalties on facilities where health and safety deficiencies are identified.”
  • and
    • The Centers for Medicare & Medicaid Services July 31 released the fiscal year 2025 final rule for inpatient rehabilitation facilities, which will update IRF payments by an estimated 3% overall (or $300 million) in FY 2025. This includes a 3.5% market basket update, which is reduced by a 0.5 percentage point cut for productivity. However, IRF payments will be further decreased by an estimated 0.2% ($20 million) due to the updated outlier threshold. 
  • and
    • “The Centers for Medicare & Medicaid Services July 31 issued the final rule for the inpatient psychiatric facility prospective payment system for fiscal year 2025. CMS will increase IPF payments by a net 2.5%, equivalent to $65 million, in FY 2025. This increase includes a market-basket update of 3.3% minus a productivity adjustment of 0.50 percentage points; it also accounts for an update to the outlier threshold so that estimated outlier payments will remain at 2.0% of total payments, resulting in a 0.3% decrease to aggregate payments.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), announced more than $68 million in Ryan White HIV/AIDS Program funding to provide family-centered medical care and essential support services for women with low incomes, infants, children, and youth with HIV. This announcement supports and advances the Biden-Harris Administration’s National HIV/AIDs Strategy.” * * *
    • “HRSA’s Ryan White HIV/AIDS Program provides a comprehensive system of HIV primary medical care, medication, and needed support services to more than 560,000 people with HIV who have low incomes. The program focuses on tailoring approaches to best meet people with HIV and their communities where they are and addressing factors, like access to food, childcare, housing, and transportation that directly affect the ability of patients to enter and stay in care.”  
  • Govexec informs us,
    • “The Senate Homeland Security and Governmental Affairs Committee on Wednesday unanimously advanced legislation codifying recent changes to the federal hiring process stressing applicants’ skills and experience over educational attainment.” * * *
    • “By a 10-1 vote, the panel [also] moved legislation expanding the list of federal positions in which employees are “further restricted” from partisan political activity under the Hatch Act. Sen. Rand Paul, R-Ky., was the lone dissenter.
    • “The bill (S. 4656), introduced by Sen. Chuck Grassley, R-Iowa, and Committee Chairman Gary Peters, D-Mich., would add employees of agency offices of inspectors general to the Hatch Act’s list of employees with additional guard rails on political activity, alongside other oversight agencies like the Office of Special Counsel and Merit Systems Protection Board and national security organizations like the National Security Agency and FBI.”

From the public health and medical research front,

  • STAT News lets us know,
    • “Patients with early Alzheimer’s disease treated with a medication developed by Eisai and Biogen for up to three years experienced less cognitive decline than what’s expected of untreated patients based on historical data, according to new study results reported Tuesday. The manufacturers said the data support long-term, continuous use of the drug.
    • “The three-year benefit seen in patients provided Leqembi remains modest — a 31% slowing of cognitive decline, slightly more than a 27% slowing previously seen in an 18-month placebo-controlled trial. It’s still unclear if the new data will convince doctors to use Leqembi continuously, or if the treatment’s benefit is clinically meaningful for patients, experts told STAT. * * *
    • “Eisai’s argument for continuing Leqembi treatment contrasts with Lilly’s approach to its [similar FDA approved] drug Kisunla. Lilly argues that once amyloid is cleared in treated patients, they can stop the therapy, making Kisunla a more convenient option, and potentially less expensive compared to continuous dosing.”
  • MPR points out,
    • “The Food and Drug Administration (FDA) has approved Zunveyl (benzgalantamine) for the treatment of mild to moderate dementia of the Alzheimer type in adults.” * * *
    • “The approval of Zunveyl is a pivotal moment in the fight against Alzheimer disease as it is only the second oral AD treatment to be approved in more than a decade,” said Michael McFadden, CEO of Alpha Cognition. “Zunveyl was designed to address a critical need for a tolerable and effective treatment that can potentially enhance patients’ daily lives with improved long-term outcomes.”
    • Zunveyl is supplied as 5mg, 10mg, and 15mg delayed-release tablets. The product is expected to be available in the first quarter of 2025. 
  • The National Cancer Institute posted its latest Cancer Information Highlights.
  • At this link, Beckers Hospital Reviews points out “eight new shortages to know about, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists”

From the U.S. healthcare business front,

  • Per Beckers Payer Issues,
    • “Humana reported $679 million in net income in the second quarter of 2024. 
    • “The company published its second quarter earnings report July 31. In Q2 2023, Humana posted $959 million in net income.
    • “Total revenue in the second quarter was $29.5 billion, up 10.4% year over year. 
    • “Humana’s medical loss ratio was 89% in the second quarter.”
  • Modern Healthcare notes,
    • “An unexpected spike in inpatient utilization during the latter half of the quarter, which continued into July, dinged Humana’s finances. Executives cited the effects of the two-midnight rule, which requires insurers to cover inpatient stays when providers expect patients to remain in the hospital for at least two midnights. The company expects this trend to persist through 2024.”
  • Healthcare Dive adds,
    • “Medicare Advantage giant Humana expects to lose a “few hundred thousand” members in its marquee business next year, after seriously shrinking its benefits and exiting markets for 2025 in a bid to boost profits, the insurer disclosed Wednesday.
    • “It’s the first time Humana has estimated membership losses from culling its plans, and squares with past guesses from market watchers. MA margins should improve as a result, setting Humana on the path to a long-term target of at least 3%, management told investors on a call. Currently, analysts peg Humana’s MA margin as basically flat, as the Kentucky-based payer has been rocked by rising medical costs among seniors in the privately run Medicare plans.
    • “However, Humana also expects to emerge from 2024 stronger from a membership perspective than it previously thought. The insurer now expects to add 225,000 MA members this year, up from its previous forecast of 150,000 new lives.”
  • Per Fierce Healthcare,
    • “In its first quarter with new CEO Chuck Divita, national telehealth provider Teladoc Health posted a net loss of $838 million in Q2 that included a nearly $800 million impairment charge attributed to falling expectations for its virtual mental health solution, BetterHelp.
    • “Teladoc is withdrawing its 2024 outlook, and its three-year business outlook based on its Q2 losses. It now expects low single-digit year-over-year revenue growth for 2024. BetterHelp’s revenue in Q2 decreased 9% from Q2 2023, to $265 million.
    • “Amid slowing growth in recent quarters with a saturated telehealth market and the abrupt departure of longtime CEO Jason Gorevic in April, the company’s net loss skyrocketed in Q2 2024 to $837.7 million, or $4.92 per share, compared to a loss of $65 million, or $0.40 per share, during the same quarter a year ago.” * * *
    • “Divita said transitioning BetterHelp to accept insurance is the next logical step for the company. Customers that leave the platform cite high out-of-pocket costs and lack of insurance coverage, he noted.
    • “BetterHelp expects to have the technical capabilities for insurance coverage by year-end and expects insurance contracting to roll out over the course of 2025.”
  • Per BioPharma Dive,
    • “GSK on Wednesday lowered its forecast for vaccine sales this year, citing inventory changes and shifting retail prioritization in the U.S. for its shingles shot Shingrix.
    • “The British pharmaceutical company now expect sales from its vaccines division to increase by low to mid-single digit percentages, down from the high single digit to low double-digit growth it predicted in May.
    • “Shingrix, now one of GSK’s top products, earned 832 million pounds, or about $1.1 billion, in the second quarter, down from the first three months of the year but up year to date. Sales of Arexvy, the company’s new vaccine for respiratory syncytial virus, totaled 62 million pounds as demand eased along expected seasonal patterns.”
  • Per MedTech Dive,
    • “Stryker set another record in the second quarter for installations of its Mako orthopedic robot, ahead of two planned launches of spine and shoulder features later this year.  
    • “As you’ve seen, quarter after quarter, our Mako installations are very high. That leads to future strong demand for hips and knees,” Stryker CEO Kevin Lobo told investors on Tuesday. 
    • “This is the third quarter in a row where management has noted record installations, BTIG analyst Ryan Zimmerman said in a research note. 
    • “The results drove more than 14% sales growth in Stryker’s “other orthopedics” segment to $136 million.”
  • This link provides an explanation of how the Mayo Clinic uses the Mako orthopedic robot in hip and knee replacement surgeries.
  • Per MedPage Today,
    • “Trust in physicians and hospitals decreased sharply during the COVID-19 pandemic, and higher levels of trust were tied to greater odds of getting vaccinated for COVID-19 or influenza, according to a survey study of U.S. adults.
    • “Among over 400,000 unique respondents, the proportion of adults who agreed they had “a lot of trust” in physicians and hospitals declined from 71.5% in April 2020 to 40.1% in January 2024, reported Roy Perlis, MD, MSc, of Massachusetts General Hospital in Boston, and colleagues in JAMA Network Open. * * *
    • In regression models, factors associated with lower trust as of the spring and summer of 2023 included being 25 to 64 years of age, female gender, lower educational level, lower income, Black race, and living in a rural setting. Even when the researchers controlled for partisanship, these associations persisted. * * *
    • “We as physicians and public health officials can talk until we’re blue in the face about things like vaccination and other public health behaviors,” Perlis commented. “But if people don’t trust us, it doesn’t matter — we’re talking to ourselves.” * * *
    • “Perlis and his team also gathered information about why respondents had low levels of trust. Participants with the two lowest levels of trust identified the following reasons: financial motives over patient care (35%), poor quality of care and negligence (27.5%), influence of external entities and agendas (13.5%), and discrimination and bias (4.5%).”
  • FEHBlog observation: Wow.
  • The Society for Human Resource Management tells us,
    • “After an unexpected surge in pay and benefits in the first quarter, labor costs have slowed down in the second quarter but still remains robust.
    • “The Employment Cost Index (ECI) increased 0.9% in the second quarter of the year, new data finds, after rising 1.2% last quarter, according to Bureau of Labor Statistics data released July 31. Wages and salaries increased 0.9% and benefit costs increased 1% from March 2024. Many economists forecasted that the ECI would rise 1%.
    • “Year over year, compensation costs in the U.S. for civilian workers—including pay and benefits—rose 4.1%, down slightly from the 4.2% year-over-year rise in the first quarter of 2024. Meanwhile, compensation for state and local government workers is up 4.9%.
    • “Wages and salaries grew 4.2% for the 12-month period ending in June 2024 and rose 4.6% for the 12-month period ending in June 2023, according to the BLS. Benefit costs grew 3.8% over the year and rose 4.2% for the 12-month period ending in June 2023.” * * *
    • “Although wage growth appears to be slowing, it’s still robust, said Sydney Ross, junior economic researcher at SHRM.
    • “As shown in the recent JOLTS report, employers are still dealing with a tight labor market and persistent talent shortages across key industries,” she said. “This means there will be more competition between employers for skilled talent, especially for those in specialized industries.”

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.


Weekend Update

David Ermer–Congress, Medical / Rx research, Mental health care, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Washington, DC,

  • While the House of Representatives has begun its August recess, the Senate will continue Committee business and floor voting this week.
  • Roll Call notes,
    • “The Department of Veterans Affairs is facing a nearly $15 billion combined budget shortfall this fiscal year and next, and congressional Republicans are crying foul at the last-minute notification about a funding crisis lawmakers have little time to try to fix.
    • “VA officials told lawmakers on July 15 that the agency needs $2.9 billion in mandatory spending for veterans’ pensions and other benefits to cover a gap for the remaining months of the fiscal year ending Sept. 30. And they need another $12 billion in discretionary medical care funds for next year on top of what was provided in a March appropriations package or in the fiscal 2025 House and Senate Military Construction-VA bills.
    • “The notification came after the House passed its fiscal 2025 Military Construction-VA bill on June 5, and after the Senate Appropriations Committee marked up its version on July 11.” * * *
    • “According to agency officials, the crux of the issue is increased demand for health care services amid implementation of a 2022 law that expanded access for veterans exposed to burn pits and other toxins while serving in combat zones. Previously, veterans who got sick needed to prove their illnesses were directly tied to their military service; now, the presumption is such diseases are service-connected. [FEHBlog note — The cost of VA treatment for service-connected medical issues cannot be passed along to the FEHBP or other health plans.}
    • “Over the last 365 days, 412,867 veterans have enrolled in VA care — a 27 percent increase compared to the previous year, VA press secretary Terrence Hayes said Thursday.” * * *
    • “It’s not clear how lawmakers will move to address the shortfall.”

From the public health and medical research front,

  • The New York Times reports
    • “Scientists have made another major stride toward the long-sought goal of diagnosing Alzheimer’s disease with a simple blood test. On Sunday [July 28], a team of researchers reported that a blood test was significantly more accurate than doctors’ interpretation of cognitive tests and CT scans in signaling the condition.
    • “The study, published Sunday in the journal JAMA, found that about 90 percent of the time the blood test correctly identified whether patients with memory problems had Alzheimer’s. Dementia specialists using standard methods that did not include expensive PET scans or invasive spinal taps were accurate 73 percent of the time, while primary care doctors using those methods got it right only 61 percent of the time.” * * *
    • “The results, presented Sunday at the Alzheimer’s Association International Conference in Philadelphia, are the latest milestone in the search for affordable and accessible ways to diagnose Alzheimer’s, a disease that afflicts nearly seven million Americans and over 32 million people worldwide. Medical experts say the findings bring the field closer to a day when people might receive routine blood tests for cognitive impairment as part of primary care checkups, similar to the way they receive cholesterol tests.”
  • An author writes an opinion column in the Washington Post about visiting happy to chat park benches in London, England where she opened up with strangers thereby boosting her Vitamin S.
    • “There’s some science to this. Paul van Lange, a Dutch psychologist, labels the phenomenon “Vitamin S.” His research shows that strangers often confide in each other: “Most of our relationships include a power dynamic even if we’re unaware of it. But two strangers on a bench are equal and equally vulnerable,” he told me. And strangers don’t carry the risk of spilling our secrets to the rest of our social network. Van Lange’s studies also show that these interactions can promote mental well-being, explaining why my bench chats were such a mood booster.
    • “But Vitamin S has other benefits, too. Talking to strangers is like an exercise — we need to practice it regularly or risk losing the muscle for it. This “mental fitness” is bolstered when our brains use infrequently activated neural networks to converse with strangers.”
  • The idea has crossed the pond to the U.S.
  • The Post also discusses the summertime risks of having a pedicure.
    • “David Murgueytio had his first pedicure about two years ago in a Rockville, Md., nail salon. It also was his last.
    • “The pedicurist pushed his cuticles back with a sharp little scooped tool — “he dug in deep — and it hurt,” he says. The next morning, the big toe on his right foot was red and swollen. Two weeks later, when he finally went to a doctor, the toe had turned an alarming shade of dark green — “nearly black,” he says, “and I could hardly walk.”
    • “Murgueytio, 40, a personal trainer from Clarksburg, Md., recovered after a 14-day course of antibiotics and a warning from his doctor about taking too long to be seen, risking an infection that could spread to the rest of his body. He learned his lesson. “I’m doing my own toes now,” he says.” * * *
    • “With summer underway, it’s often tempting to go barefoot, especially at the pool or beach. This can be risky after a pedicure if the cuticles have been recently cut or trimmed, experts say.
    • “I wouldn’t walk through the sand barefoot,” says Adam Friedman, professor and chair of dermatology at the George Washington University School of Medicine and Health Sciences. “Little particles of sand can get in, causing irritation and inflammation, and introducing bacteria and other microorganisms.” (This is true for any open cuts or wounds, not just from pedicures.)”
  • Fortune Well also discusses how much water adults should drink daily.
    • “Water is essential for your body’s survival,” says Crystal Scott, registered dietitian-nutritionist with Top Nutrition Coaching. “It helps regulate your temperature, transports nutrients, removes waste, lubricates your joints and tissues, and it also plays a crucial role in maintaining the delicate balance of electrolytes and fluids in your body.” * * *
    • “The National Academy of Science, Engineering and Medicine recommends an average daily water intake of about 125 ounces for men and about 91 ounces for women. If you’re not filling up a water bottle to exactly that amount every day, you’re probably still close or even over, because you also get water from food, says Scott.
    • “You can get a lot of hydration from foods like celery, oranges, strawberries, watermelon, and cucumbers,” she says. “All are hydrating foods that can actually help supplement your water intake.” * * *
    • “For the majority of the population, the bigger issue is getting enough water. While it’s helpful to keep tabs on actual ounces, the best indicator of whether you’re well hydrated is your body. When you don’t get enough water, your body will show certain signs.
    • “Urine color is a really great indicator of hydration status,” says Scott. If your toilet water is pale yellow or clear after you pee, you’re golden. Dark yellow or amber colored urine are signs your body needs fluids.”
    • “When in doubt, go to the spout.”

From the U.S. healthcare business front,

  • In MedPage Today, an emergency room physician explains the phenomenon of “induced demand” as applied to emergency facilities.
    • Induced demand is economist-speak for the concept that building more of something in high demand can actually increase demand for that thing.  * * *
    • Today, U.S. emergency departments (EDs) face a conundrum [similar to highway traffic congestion] — seemingly limitless demand for emergency services. Beginning in 2012, the annual number of ED visits nationally jumped from 131 to 150 million in just 7 years, easily outstripping population growth. A recent study in California found that from 2011 through 2019, ED visits increased 23.4% while the state’s population grew by only 5%. * * *
    • “During my 20 years as a frontline emergency medicine physician, my healthcare organization has added both a hospital and an urgent care to my service area, created additional shifts at each of our facilities, and ramped up the speed at which physicians treat patients. After a decade of well-intended capacity expansion, our ED volumes remain at an all-time high. In the context of a national healthcare worker shortage, staffing often becomes the rate-limiting step that ultimately kills further expansion attempts. As the authors of the UC Davis study gamely note, “ED expansion alone does not appear to be an adequate solution to ED crowding.” * * *
    • “[O]ne effective approach to decreasing traffic relies on the concept that one of the most effective deterrents to congestion is congestion itself. Posting highway travel times sets realistic expectations and helps drivers make wiser decisions about whether it’s worth it to continue their trip. * * * This may be what the Academic College of Emergency Physicians (ACEP) was thinking when it proposed posting wait times and triaging low acuity patients to a non-ED setting.” * * *
    • “A proliferation of alternate care options such as urgent care and telemedicine appointments now make this concept of redistributed flow all the more realistic.”
  • MedTech Dive interviewed “Stacey Churchwell, general manager of Medtronic’s cardiovascular diagnostics and services business, to discuss the company’s integration of AI algorithms for detecting abnormal heart rhythms into its insertable cardiac monitors (ICMs). The miniature devices — the latest version is about a third the size of a triple A battery — are implanted under the skin in a patient’s chest to help diagnose abnormal heart rhythms such as atrial fibrillation (AFib).” 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.

Thursday Miscellany

David Ermer–CDC, Congress, Medical / Rx research, NCQA, Obesity, U.S. Healthcare–

From Washington, DC,

  • Govexec reports,
    • [On Monday July 21, the House of Representatives passed] “the Billion Dollar Boondoggle Act, was already approved by the Senate in March. 
    • “It would require agencies to report annually to Congress about their projects that are more than five years behind schedule or are $1 billion or more over budget. 
    • “Specifically, the measure would require an explanation for the delay or cost increase as well as a justification for any award, incentive fee or other type of bonus awarded with respect to the project. 
    • “It’s a bad day for boondoggles, but a very good one for taxpayers!” bill sponsor Sen. Joni Ernst, R-Iowa, said in a statement following House passage.” 
  • and
    • “The House also cleared the GOOD Act, which would mandate agencies to post their guidance documents online in a single location on the day they are issued. 
    • “Unfortunately, agency guidance documents are difficult to find, leaving Americans and small businesses guessing, and oftentimes struggling, to comply with the law. The Guidance Out of Darkness Act rights this wrong by requiring federal agencies to be transparent about interpretations of the law through publishing guidance in an easily accessible, online location,” said House Oversight and Accountability Chairman James Comer, R-Ky., who also sponsored the bill, in a statement. “Laws should not be implemented based on guidance that’s kept in the dark.”
    • “It also would require agencies to publish previously issued guidance documents that are still in effect to the same website.”
    • This bill now goes to the Senate for consideration.
  • Govexec also informs us,
    • “The Office of Personnel Management on Thursday finalized new regulations intended to ensure that federal workers who are temporarily promoted are paid appropriately for the duration of their detail.” * * *
    • “The new rule will go into effect on Aug. 26. In a memo to agency HR directors, OPM Associate Director for Workforce Policy and Innovation Veronica Hinton sought to reassure agencies that the new rule only applies in certain circumstances, providing an FAQ on the issue.”
  • The Washington Post tells us,
    • “A Senate committee Thursday formally opened a bipartisan investigation into Steward Health Care, the nation’s largest physician-led hospital system, and voted to subpoena the company’s CEO, alleging that Steward executives had mismanaged the system’s finances and put patient care at risk.
    • “Steward, a for-profit company that owns 31 hospitals across the country, is in bankruptcy proceedings and has been seeking to sell its hospitals. Community leaders and health workers in states served by Steward’s facilities, such as Massachusetts, have blamed Steward leaders for extravagant paydays even as hospitals struggled to meet mortgage payments and cover other expenses. The Justice Department also has been probing the company over allegations of fraud.”
    • “Senators on the Health, Education, Labor and Pensions Committee echoed those concerns Thursday and said Steward warranted a national spotlight on Capitol Hill, accusing the hospital system’s leaders of “outrageous corporate greed” that harmed access to medical services, such as spending nearly $100 million on a pair of private jets. Lawmakers on the committee have been investigating the system for months.”

From the public health and medical research front,

  • The Washington Post relates,
    • “A twice-yearly injection could help prevent HIV infections, according to the results of a new study described by medical experts as a breakthrough.
    • “In a randomized trial involving more than 5,000 young women and girls in South Africa and Uganda, none of those who received the prevention shots contracted HIV. The results were published in the New England Journal of Medicine on Wednesday.
    • “This appears to be a new breakthrough for HIV prevention. If these injections can be widely distributed at low cost, it would dramatically reduce the risk of new HIV infections worldwide,” said Sarah Palmer, co-director of the Center for Virus Research at the Westmead Institute for Medical Research in Sydney, who was not involved in the peer-reviewed study. “It is especially encouraging this research focused on young women in Africa who are so highly at-risk for HIV infection.” * * *
    • “The shots were produced by drugmaker Gilead Sciences, which funded the trial, and some of the researchers were Gilead employees. Lenacapavir, sold under the brand name Sunlenca, is approved as a treatment for HIV infections in the United States. The goal of the trial was to prove its safety and efficacy for the prevention of infection in adolescent girls and young women. A separate trial for men is underway.”
  • ‘The New York Times reports,
    • “For the more than 310,000 women diagnosed with breast cancer every year, no matter how well the treatment goes, there is always a lingering fear. Could the disease come back, even years later? And what if it comes back in the other breast? Could they protect themselves today by having a double mastectomy?
    • “A study has concluded that there is no survival advantage to having the other breast removed. Women who had a lumpectomy or a mastectomy and kept their other breast did just as well as women who had a double mastectomy, Dr. Steven Narod of Women’s College Hospital in Toronto and his colleagues reported, using U.S. data from more than 661,000 women with breast cancer on one side.
    • “In the study, published in JAMA Oncology on Thursday, the researchers added that most women did very well — the chance of cancer in the other breast was about 7 percent over 20 years.
    • “But the study’s results may not apply to women who have a gene variant, BRCA1 or BRCA2, which greatly increases their cancer risk. For the 1 in 500 American women with this variant, cancer researchers agree that it’s worth considering a double mastectomy.” * * *
    • “Dr. Angela DeMichele, a professor of medicine and co-leader of the breast cancer program at the University of Pennsylvania “says she carefully explains to patients that they have a real choice in treatment — they don’t have to have a double mastectomy.
    • “Many women, she said, assume that the more surgery they have, the more likely they are to be cured. So, they want both breasts removed.
    • “She tells them that removing the second, healthy breast does not prevent cells from their newly diagnosed cancer from spreading to other organs and to bones. “That is why chemotherapy and hormonal therapies are so important,” she tells patients. “They are designed to kill these cells.”
  • Per Beckers Hospital Review,
    • “A newly tested combination therapy showed a higher rate of survival compared to chemotherapy alone, according to a study published July 24 in The New England Journal of Medicine.
    • “Researchers from academic institutions including Mayo Clinic in Rochester, Minn., and the Dana-Farber Cancer Institute in Boston, conducted a clinical trial testing the combination therapy of blinatumomab plus chemotherapy on the survival rates of patients with B-cell precursor acute lymphoblastic leukemia.” * * *
    • “These results are encouraging and establish a new standard of treatment for people with BCP-ALL. The addition of blinatumomab to chemotherapy reduced the risk of leukemia recurrence and death by nearly 60%,” Mark Litzow, MD, lead study author and hematologist at the Mayo Clinic Comprehensive Cancer Center, said in a July 24 news release from the Mayo Clinic.” 
  • and
    • “About 28% of knee and hip replacements are performed on people younger than 55 and the trend is expected to grow, U.S. News & World Report reported July 24.
    • “By 2030, people younger than 65 are expected to account for 52% of hip replacements and 62% for total knee replacements, according to research presented at the American Academy of Orthopedics’ annual meeting in 2023. Researchers utilized data from 5,153 patients in the American Joint Replacement Registry that had a total hip arthroplasty performed between 2012 and 2020.
    • “Many of those younger adults are former athletes.”
  • The American Medical Association lets us know what doctors wish their patients knew about pink eye.
  • The Hill notes,
    • “Teen births declined 69 percent from 2000 to 2022, according to newly released federal data, but racial and ethnic disparities continue to exist.  
    • Births declined at similar rates across all races, but Black, Native American and Hispanic teenagers still had higher birth rates in 2022 than white, non-Hispanic teens, according to the data from the Centers for Disease Control and Prevention. 
  • U.S. News and World Report adds,
    • “For the first time in two decades, the infant mortality rate in the United States has risen, new government data shows.
    • “In a report released Thursday by the U.S. Centers for Disease Control and Prevention, researchers found that more than 20,500 babies died in 2022 before the age of 1. Overall, there were 5.6 infant deaths for every 1,000 live births, a 3% increase from the year before.
    • “Infant health is one of the most important public health indicators that we have,” Amanda Jean Stevenson, a demographer and assistant professor of sociology at the University of Colorado Boulder, told CNN.
    • “The fact that [infant mortality rates] are not continuing to decrease is a very big deal. Even flat infant mortality rates are not good,” she added. “We need to see these numbers going down — and fast — because they are far too high.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Hospitals are finally emerging from the pandemic’s lasting disruption to labor markets, adding nurses and other critical workers who left the market or job hopped for higher pay. 
    • “HCA Healthcare and Tenet Healthcare, two of the nation’s largest hospital and surgery-center companies, reported this week their hospitals are busy and are expected to stay that way through the year. Hiring has opened up services they had closed because of the pandemic and a tight labor market, company executives say.
    • “In totality, the strength in the hospital segment has been significant,” said Dr. Saum Sutaria, Tenet’s chief executive, on a call with analysts after the company posted its earnings this week. “We feel optimism about the demand that we see.”
  • In that regard, Healthcare Dive points out,
    • “Tenet Healthcare reported second-quarter earnings Wednesday that beat analysts’ estimates, drawing in a net income of $259 million on strong demand for outpatient services. 
    • “The Dallas-based provider raised its full-year guidance again following the results. Tenet was the only major for-profit provider to raise its full-year forecast following first-quarter earnings.
    • “Tenet now expects to bring in $3.8 billion to $4 billion in adjusted earnings before interest, taxes, depreciation and amortization — a $300 million increase over previous projections.” 
  • and
    • “Universal Health Services posted a second quarter net income of $289.2 million on Thursday and modestly revised its full-year revenue guidance up by 0.3% to 1%.
    • “However, CFO Steve Filton said on the company’s earnings call that acute care hospitals experienced a “moderation of demand” for services during the quarter, with adjusted admissions increasing 3.4% year over year and surgical growth “flattening out.” 
    • “The King of Prussia, Pennsylvania-based health system reported progress on controlling expenses — notably physician fee costs, which have plagued the system for multiple quarters. Executives called further cost controls critical to UHS’ efforts to get back to pre-pandemic operating margins.”
  • Per Beckers Hospital Review,
    • “St. Louis-based Ascension has taken another step in its effort to reorganize its portfolio — a strategy designed to enhance operating performance and ensure sustainability.
    • “The latest transaction is in the Midwest. Ontario, Calif.-based Prime Healthcare has entered into an asset purchase agreement with Ascension to acquire hospitals and care sites in Illinois.”
  • and
    • “Optum is closing clinics in multiple states and laying off 524 employees across California.
    • “According to regulatory documents filed July 18, the UnitedHealth Group company will terminate the California employees from Sept. 16 through January 2025 at clinic and administrative office locations in Hayward, Glendora, Montbello, Covina, Pasadena, Long Beach, Los Angeles, Irvine, Beaumont, Redlands, Highland, El Segundo, and Cerritos. The layoffs include some remote employees in other states.”
  • Healthcare Dive further notes,
    • “Investors came into second-quarter earnings for Molina concerned about how challenges in its core Medicaid business might affect the insurer. However, Molina exceeded Wall Street’s expectations for earnings and revenue in finances released aftermarket Wednesday.
    • “Molina reported revenue of $9.9 billion, up almost 19% year over year thanks to the insurer winning new Medicaid contracts and growing its existing businesses. Net income of $301 million was down slightly year over year due to an increase in spending on Medicaid beneficiaries, but still better than analyst forecasts.
    • “Medicaid pressures should ameliorate over the back half of the year, Molina executives told investors on a Thursday morning call. Molina is also open to additional M&A, despite coming off two recent acquisitions, and plans to stand up a new business to oversee its growth strategy in dual-eligible Medicare and Medicaid plans.”
  • Per Beckers Payer Issues,
    • “CareFirst Blue Cross Blue Shield credits a critical partnership with achieving top-tier results for Type 2 diabetes care. 
    • “CareFirst partnered with Ryse Health, a chain of clinics in the Washington, D.C. and Baltimore areas, focused exclusively on managing diabetes. CareFirst members who received care at Ryse Health clinics had, on average, scores in the 95th percentile for several HEDIS measures.
  • and
    • “UnitedHealth Group will invest $25 million for housing for veterans experiencing homelessness and low and middle-income individuals. 
    • “The grant will go to the Community Solutions Large Cities Housing Fund, a $135 million fund backed by Kaiser Permanente, Wells Fargo and other large donors. The fund directly acquires apartment units. Half of these units are reserved for individuals transitioning out of homelessness, including veterans, according to a July 24 news release.” 
  • Per BioPharma Dive,
    • “Viking Therapeutics shares soared by more than 30% early Thursday after the company told investors it’s moving an experimental obesity drug into Phase 3 testing earlier than expected and exploring more convenient dosing.
    • “The medicine, dubbed VK2735, has already shown promising results in a Phase 2 trial released in February. In that study, patients lost as much as 15% of their body weight after 13 weeks of treatment with the drug, findings that suggest Viking’s option might be a future threat to blockbuster obesity medications sold by Novo Nordisk and Eli Lilly.
    • “Analysts expected the next step would be a Phase 2b trial. But late Wednesday, Viking said it’s moving directly to Phase 3 after a meeting with Food and Drug Administration officials. The company also plans to study monthly injections for the medicine, potentially offering another advantage over the once-weekly products available now.”
  • and
    • “Roche is best known for the cancer drugs that still account for much of its drug revenue. But the Swiss pharmaceutical giant spent much of its latest quarterly earnings call fielding questions about a pair of experimental weight loss medicines that have fast become important to its future growth.
    • “Roche last year acquired those medicines in a $2.7 billion deal for biotechnology company Carmot Therapeutics. One, CT-388, is an injectable therapy, while the other, CT-996, is a pill. Since May, both have since shown the potential in early trials to spur significant weight loss, adding billions to Roche’s market value and making the company a surprise player in one of the most lucrative areas of drug research.
    • “It’s going to be a huge market,” CEO Thomas Schinecker said on a conference call. “By 2035, about 50% of the world’s population will be obese.”


Midweek update

David Ermer–CDC, CMS, Congress, Federal employment benefits, Medical / Rx research, Medicare, OPM, Telehealth, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC,

  • At long last, the federal employee press is publicizing the Part D opt out penalty found in the proposed supplemental Postal Service Health Benefits (PSHB) Program rule.
  • Federal News Network reports, “There’s a catch in USPS insurance program for Medicare-eligible retirees. USPS annuitants who opt out of Medicare Part D will lose underlying prescription drug coverage, according to OPM’s [proposed] regulations.” Those opt out annuitants will continue to pay the full premium.
  • OPM reads the PSHB law as only offering Part D EGWP benefits to Part D eligible annuitants in the PSHBP. There is no underlying Rx coverage according to the agency’s FAQs. That statutory interpretation puts federal employees who live overseas in quite a pickle because Part D coverage is not available outside the United States.
  • In any case, it’s the FEHBlog’s legal opinion that the opt out penalty may not survive judicial review in our post-Chevron era, and because the penalty is roughly 20% of the premium, annuitants may be incented to bring a lawsuit challenging the penalty. Time will tell.
  • Govexec tells us,
    • “The Office of Personnel Management is opening a channel to provide federal employees affected by Hurricane Beryl to obtain emergency paid leave.  FEHBlog note: Beryl hit Houston TX hard.
    • “Acting OPM director Robert Shriver said in a July 19 memo that the agency had established an emergency leave transfer program, by which other federal employees may donate unused annual leave to impacted employees through the creation of agency leave banks. 
    • “Through the agency leave banks, impacted employees “who are adversely affected by a major disaster or emergency, either directly or through adversely affected family members, and who need additional time off from work” can utilize donated leave without having to use their own.” 
  • Per Fierce Healthcare,
    • “The Centers for Medicare & Medicaid Services (CMS) has released new data on risk adjustment payments for 2023.
    • “The agency said (PDF) insurers participating on the Affordable Care Act’s exchanges will pay $10.3 billion as part of the risk adjustment program. Risk adjustment state transfers as a percent of premiums declined from 2022, according to the report.
    • “This trend is likely driven by shifts in the risk pools, according to CMS, which are likely impacted by ongoing insurer expansion into new regions.”
  • The American Hospital Association News informs us,
    • “The Substance Abuse and Mental Health Services Administration July 24 announced it is awarding $45.1 million in grants toward various behavioral health initiatives. The funding includes $15.3 million specifically planned to support children through mental health services in schools, services for those who have experienced traumatic events, and services specific to those at risk for or with serious mental health conditions.” 
  • Roll Call reports,
    • “House leaders canceled votes scheduled for next week as the GOP majority struggles to pass its fiscal 2025 appropriations bills.
    • “The decision to scrap next week’s session came a day after Republican leaders had to yank the Energy-Water spending bill from the floor amid growing doubts they could muster enough votes to pass it with their razor-thin majority. * * *
    • “GOP leaders all week had been mulling the possibility of sending members home early rather than remain in session next week as previously scheduled. Speaker Mike Johnson, R-La., said Wednesday that the decision to cancel votes next week wasn’t a direct result of problems with the appropriations bills.
    • “It’s not related to that. We’ve had a tumultuous couple of weeks in American politics and everybody’s, to be honest, still tired from our convention, and it’s just a good time to give everybody time to go home to their districts and campaign a little bit. We’ll come back and regroup and continue to work on this.”
    • “Johnson also said funeral arrangements for Rep. Sheila Jackson Lee, D-Texas, who died last weekend after a battle with pancreatic cancer, would pose logistical challenges next week. Johnson said a lot of members would want to attend the events, to be held in Houston, which could keep members away from Washington for three days.”
  • Per a Senate press release,
    • “Senate Finance Committee Chair Ron Wyden, D-Ore., and five senators today introduced a bill to apply criminal penalties to rogue insurance brokers who are changing Americans’ Affordable Care Act (ACA) marketplace plans without their knowledge or consent, and take other steps to strengthen consumer health insurance protections. * * *
    • “The one-pager is available here. A summary of the bill is available here. The bill text is available here.”

From the public health and medical research front

  • ABC News relates,
    • “So far, only 25 cases of West Nile virus have been reported in 14 states, according to data from the Centers for Disease Control and Prevention. This is lower than the 117 cases reported at the same time last year. * * *
    • “Mosquitoes typically become infected with the virus after feeding on infected birds and then spread it to humans and other animals, the federal health agency said. Cases typically begin rising in July and are highest in August and September, CDC data shows.
    • “The majority of people with the virus do not have symptoms, but about one in five will experience fever along with headaches, body aches, joint pain, diarrhea, vomiting or a rash. Most symptoms disappear but weakness and fatigue may last for weeks or months.
    • “About one in 150 will develop severe disease leading to encephalitis, which is inflammation of the brain, or meningitis, which is inflammation of the membranes that surround the brain and spinal cord — both of which can lead to death. So far this year, 11 of the 25 cases have resulted in neuroinvasive disease, according to the CDC.
    • “There are currently no vaccines or specific treatments available for West Nile virus. The CDC recommends rest, fluids and over-the-counter medications. For those with severe illness, patients often need to be hospitalized and receive support treatments such as intravenous fluids.
    • “To best protect yourself, the CDC suggests using insect repellant, wearing long-sleeved shirts and pants, treating clothing and gear and taking steps to control mosquitoes. This last step includes putting screens on windows and doors, using air conditioning and emptying out containers with still water.”
  • The New York Times adds,
    • “As the bird flu outbreak in dairy cows has ballooned, officials have provided repeated reassurances: The virus typically causes mild illness in cows, they have said, and because it spreads primarily through milk, it can be curbed by taking extra precautions when moving cows and equipment.
    • “A new study, published in Nature on Tuesday, presents a more complex picture.
    • “Some farms have reported a significant spike in cow deaths, according to the paper, which investigated outbreaks on nine farms in four states. The virus, known as H5N1, was also present in more than 20 percent of nasal swabs collected from cows. And it spread widely to other species, infecting cats, raccoons and wild birds, which may have transported the virus to new locations.
    • “There’s probably multiple pathways of spread and dissemination of this virus,” said Diego Diel, a virologist at Cornell University and an author of the study. “I think it will be really difficult to control it at this point.” * * *
    • Although many infected cows did recover on their own, the researchers found, two farms reported a spike in cow deaths. On the Ohio farm, 99 cows died over the course of a three-week outbreak, a mortality rate roughly twice as high as normal.
    • “I think the potential for this virus to cause very serious disease has been downplayed a bit,” said Richard Webby, an influenza expert at St. Jude Children’s Research Hospital, who was not involved in the new study. “That has probably hurt the response.”
    • “Still, Dr. Diel noted, the cause of these deaths remains unknown. “Whether the mortality observed in those cases was due directly to influenza or whether the influenza infection led to a secondary bacterial infection, I think that’s a question that remains to be answered,” he said.”
  • Per BioPharma Dive,
    • “An experimental gene therapy from Pfizer succeeded in a Phase 3 study of people with hemophilia A, overcoming safety concerns that had put the trial on hold for almost a year.
    • “The treatment, giroctocogene fitelparvovec, is a one-time infusion designed to help patients produce a protein called Factor VIII that’s needed for normal blood clotting. Currently, people with hemophilia A use infusions of Factor VIII to prevent bleeding episodes.
    • “In the AFFINE study, researchers followed 75 patients for at least 15 months after they received Pfizer’s therapy. Study participants had fewer bleeding episodes and higher levels of Factor VIII, compared with standard prophylactic treatment before the infusion, Pfizer said Wednesday. Only one treated patient returned to prophylactic infusions.”
  • Healio notes that “In a single-center cohort of patients with heart failure and obesity, weight-loss surgery led to improved clinical outcomes including reduced BMI and HbA1c and less reliance on diuretics, researchers reported.”
  • mHealth Intelligence reports,
    • “There has been a “notable jump” in the percentage of employers offering deductibles of $4,000 or more — from 36% to 45% — according to a survey of more than 6,000 employers conducted by employee benefits firm Alera Group. 
    • “More companies are also offering qualified high-deductible health plans (up from 47% to 52%), Alera Group found. The survey also found, perhaps unsurprisingly, that 4 in 5 medical plans experienced a rate increase over the past year.
    • “Employers appear to be managing increased costs by providing more choices, with more than half of large employers offering three or more plan options. More employers are also exploring self-funding, Alera Group found.”

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “Humana’s CenterWell is planning to open 23 clinics at Walmart locations in four states, the company announced Wednesday.
    • “The health clinics will operate in space that previously held Walmart’s own clinics, according to the announcement. CenterWell intends to have the locations across Florida, Georgia, Missouri and Texas fully equipped, staffed and opened by the first half of 2025.
    • “The locations will operate under both the CenterWell and Conviva brands, providing senior-focused primary care. CenterWell is the fastest-growing senior-focused primary care provider in the nation, Humana said.”
  • Per Healthcare Dive,
    • “S&P Global Ratings analysts have downgraded Walgreens Boot Alliance by two notches, to ‘BB’ from ‘BBB-’, which puts the drugstore company into speculative-grade territory.
    • ‘Analysts Diya Iyer and Hanna Zhang cited guidance for the year “notably below” their expectations, and said “material strategic changes, limited cash flow generation, and large maturities in coming years are key risks to the business.”
    • “The company is struggling in its retail business as well as its pharmacy operations, they said in a Friday client note. In the U.S., margins are taking a hit on the pharmacy side from reimbursement pressure and on the retail side from declining sales volume and higher shrink. They expect Walgreens’ S&P Global Ratings-adjusted EBITDA margin to decline more than 100 basis points this fiscal year, dipping below 5%, from 6% last year, though the company’s cost cuts will counter that somewhat.”
  • MedTech Dive points out the top five medtech deals in the first half of 2024.
  • Per HR Dive,
    • “There has been a “notable jump” in the percentage of employers offering deductibles of $4,000 or more — from 36% to 45% — according to a survey of more than 6,000 employers conducted by employee benefits firm Alera Group. 
    • “More companies are also offering qualified high-deductible health plans (up from 47% to 52%), Alera Group found. The survey also found, perhaps unsurprisingly, that 4 in 5 medical plans experienced a rate increase over the past year.
    • “Employers appear to be managing increased costs by providing more choices, with more than half of large employers offering three or more plan options. More employers are also exploring self-funding, Alera Group found.”

    Tuesday Tidbits

    David Ermer–Congress, Electronic health records, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–
    Photo by Patrick Fore on Unsplash

    From Washington, DC

    • Modern Healthcare reports,
      • “Lawmakers and executives from three major pharmacy benefit managers presented diametrically opposing views at a heated Capitol Hill hearing Tuesday, as major bills aimed at reining in the organizations remain stalled in Congress. 
      • “Members of the House Committee on Oversight and Accountability blamed the highly concentrated PBM industry for raising drug prices and running independent pharmacies out of business, while leaders from CVS Caremark, Express Scripts and Optum Rx all countered that the sector in fact lowers prices and supports local pharmacies.
      • “The hearing accompanied the committee’s release of a report detailing what its investigators characterized as abuses by the three large companies.”
    • Govexec lets us know,
      • “A federal employee group within the Justice Department last week made its final pitch to the federal government’s dedicated HR agency to boost the federal government’s coverage of in vitro fertilization and other assisted reproductive technology through the Federal Employees Health Benefits Program.
      • “The Department of Justice Gender Equality Network, an employee association representing nearly 2,000 workers at the Justice Department, sent acting Office of Personnel Management Director Rob Shriver three dozen testimonials from members describing the hardships they endured while trying to conceive. The move comes amid OPM’s final round of negotiations with insurance carriers over what FEHBP plans will cover next year.”
    • Federal News Network tells us,
      • “More than 15 years in the making, plans to update the federal pay system for blue-collar government employees are finally gaining some traction.
      • “A proposal to reform the Federal Wage System (FWS) has moved into the early stages of the government’s rulemaking process, the Federal Prevailing Rate Advisory Committee (FPRAC) announced during a public meeting Thursday morning.
      • “The proposal, if finalized, would amend the federal pay system for blue-collar government workers, more closely aligning it with the locality pay areas for the General Schedule (GS). An estimated 15,000 blue-collar feds would see their pay rates increase.”
    • Fierce Healthcare informs us,
      • “Walgreens has received $25 million in grant funding to conduct a decentralized clinical trial assessing how well a person vaccinated against COVID-19 is protected from future infections. 
      • “The award funding comes from a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), embedded in the U.S. Department of Health and Human Services. The partnership is BARDA’s first with a major retail pharmacy. Walgreens will conduct a phase IV observational clinical study, using COVID vaccine data, to assess correlates of protection, known as responses to a vaccine that predict how well a vaccinated person will be protected from future infections, using COVID-19 vaccine data.
      • “The initiative’s goal is to increase access to clinical trials. Currently, participants in a vaccine clinical trial often travel to hospitals, universities or other central locations that are far from their homes. Taking a decentralized approach through a geographically diverse retailer like Walgreens can help reach patients where they are and enable the collection of real-world data, the organizations said. The partners also hope that learning what aspects of decentralized clinical trials work for vaccine correlates of protection studies can help drive future studies at scale.”
    • The Office of National Coordinator for Health Information Technology issued a standards bulletin that is “a companion to the USCDI v5 standard document published in July 2024. This issue provides background of USCDI v5 and the new data classes and elements that support improved patient care and advance the Administration’s goals of equity, diversity, and access to health care.”
    • The Food and Drug Administration announced,
      • On Monday, [July 22,] the FDA approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. Norethindrone acetate and ethinyl estradiol, the main ingredients in Femlyv, have been approved in the U.S. for the prevention of pregnancy as a swallowable tablet since 1968.
      • “Femlyv is the first FDA approved dissolvable birth control pill, designed for individuals who have trouble swallowing their medication,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. “There are many variables that might cause someone to have difficulty swallowing. This drug provides another treatment option and expands access to this form of contraception for individuals who may have experienced those challenges.”
      • The most common adverse reactions to Femlyv are headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain. See full prescribing information for additional information on the safety and effectiveness of Femlyv.

    From the public health and medical research front,

    • The American Hospital Association News relates,
      • “The Department of Health and Human Services July 23 released an amendment to a 2013 emergency declaration under the Food, Drug and Cosmetic Act that broadens the scope in which the agency can help facilitate certain medical countermeasures in response to a public health emergency such as a pandemic. The amendment now applies to pandemic influenza A viruses and others with pandemic potential, such as the current H5N1 strain of bird flu that has infected cattle and subsequently humans in some states. Previously, the declaration specifically covered just the H7N9 strain of bird flu. The declaration would allow the Food and Drug Administration to extend the expiration date of certain medical products and allow HHS to issue an emergency use authorization for unapproved drugs, devices or products, among other actions.”
    • Per BioPharma Dive,
      • “An experimental Merck & Co. drug designed to protect infants from illness caused by respiratory syncytial virus succeeded in a late-stage trial, the company said Tuesday.
      • “In a statement, Merck said the therapy, an antibody called clesrovimab, met its main safety and efficacy objectives in a placebo-controlled trial involving more than 3,600 healthy or preterm infants. Those goals included the incidence of RSV-associated lower respiratory infections requiring medical attention over the course of five months, compared to placebo, as well as the percentage of patients experiencing certain types of adverse events.
      • “A spokesperson told BioPharma Dive in an email that clesrovimab met a key secondary measure by reducing the risk of hospitalization from RSV in the trial. But the company didn’t provide specifics on that result or the rest of the study findings, which will be presented at a future medical meeting. In the meantime, Merck plans to share the data with global health authorities.”
    • Per National Institutes of Health press releases,
      • “Long-acting injectable cabotegravir (CAB-LA) was safe and well tolerated as HIV pre-exposure prophylaxis (PrEP) before and during pregnancy in the follow-up phase of a global study among cisgender women. The analysis of outcomes from more than 300 pregnancies and infants will be presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
      • “Cisgender women experience biological changes and social dynamics that can increase their likelihood of acquiring HIV during pregnancy and the postnatal period, and we need to offer them evidence-based options when they may need them most,” said Jeanne Marrazzo, M.D., M.P.H., director of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID). “These data provide reassurance about long-acting injectable cabotegravir for HIV prevention during pregnancy.”
    • and
      • “A single laboratory-based HIV viral load test used by U.S. clinicians who provide people with long-acting, injectable cabotegravir (CAB-LA) HIV pre-exposure prophylaxis (PrEP) did not reliably detect HIV in a multi-country study. In the study, a single positive viral load test was frequently found to be a false positive result. However, a second viral load test with a new blood sample was able to distinguish true positive results from false positive results for all participants whose initial viral load test was positive. The findings were presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
      • “We are still learning how to optimize the package of services that accompany long-acting PrEP, including HIV testing,” said Jeanne Marrazzo, M.D., M.P.H., director of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID). “The viral load testing findings observed in this study illuminate performance gaps in the current U.S. HIV testing algorithm for injectable cabotegravir PrEP.”
    • and
      • “Researchers at the National Institutes of Health (NIH) found that an artificial intelligence (AI) model solved medical quiz questions—designed to test health professionals’ ability to diagnose patients based on clinical images and a brief text summary—with high accuracy. However, physician-graders found the AI model made mistakes when describing images and explaining how its decision-making led to the correct answer. The findings, which shed light on AI’s potential in the clinical setting, were published in npj Digital Medicine.  The study was led by researchers from NIH’s National Library of Medicine (NLM) and Weill Cornell Medicine, New York City.
      • “Integration of AI into health care holds great promise as a tool to help medical professionals diagnose patients faster, allowing them to start treatment sooner,” said NLM Acting Director, Stephen Sherry, Ph.D. “However, as this study shows, AI is not advanced enough yet to replace human experience, which is crucial for accurate diagnosis.”
    • Per MedPage Today,
      • “Patients with dementia may instead have hepatic encephalopathy (HE) and should be screened with the Fibrosis-4 (FIB-4) index for cirrhosis, one of the main causes of the condition, new research suggests.
      • “The study of more than 68,000 individuals in the general population diagnosed with dementia between 2009 and 2019 found that almost 13% had FIB-4 scores indicative of cirrhosis and potential HE.
      • “The findings, recently published online in The American Journal of Medicine, corroborate and extend the researchers’ previous work, which showed that about 10% of US veterans with a dementia diagnosis may in fact have HE.”

    From the U.S. healthcare business front,

    • Healthcare Dive reports,
      • “HCA Healthcare reported second-quarter earnings that handily beat Wall Street expectations.
      • “The Nashville, Tennessee-based operator posted $17.5 billion in revenue, a net income of $1.5 billion and a 5.8% increase in same facility admissions. During a call Tuesday, HCA’s executive team attributed the company’s success to broad demand for services and an ability to manage expenses.
      • “HCA updated its full-year revenue guidance following the results. It now expects to draw between $69.8 billion and $71.8 billion, up from the originally forecast $67.8 billion to $70.3 billion.”
    • Modern Health points out,
      • “Molina Healthcare said Tuesday it is expanding into Connecticut through an agreement to acquire EmblemHealth subsidiary ConnectiCare Holding Co., for $350 million.
      • “The Farmington, Connecticut-based health insurer has approximately 140,000 members in marketplace, Medicare and other health insurance plans across the state, according to a news release. Molina said the purchase price represents a quarter of ConnectiCare’s $1.4 billion in expected 2024 revenue. The company said it will fund the deal with cash on hand and plans to close it in the first half of 2025.
      • “The ConnectiCare purchase is part of Long Beach, California-based Molina’s strategy to develop stable revenue streams and deploy capital more efficiently, President and CEO Joe Zubretsky said in the news release.
      • “The deal is Molina’s second acquisition this year. In January it completed the purchase of Bright Health Group’s California Medicare Advantage business for $425 million.”
    • Beckers Hospital Review identifies fifteen health systems that are dropping certain Medicare Advantage plans and notes,
      • Medicare Advantage accounted for around 1 in 4 inpatient hospitals days in 2022, according to a report from KFF published July 23.  * * *
      • In rural and micropolitan counties, the share of inpatient days from Medicare Advantage enrollees doubled between 2015 and 2022. 
      • Read more here. 
    • Behavioral Health Business discusses virtual applied behavioral therapy.
      • “It’s no secret that there is a steep supply-and-demand issue for applied behavior analysis (ABA) services nationwide. 
      • “The industry is relatively new, which means the pool of qualified professionals is still small compared to the need. There are less than70,000 board-certified behavior analysts in the U.S. Still, autism impacts 1 in 36 children, according to the CDC. 
      • “Many of those qualified clinicians are prioritizing flexibility in the workplace and turning to telehealth.”

    Monday Roundup

    David Ermer–ACA, CDC, CMS, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–
    Photo by Sven Read on Unsplash

    From Washington, DC,

    • Healthcare Dive reports,
      • “The Biden administration is making it harder for insurance agents and brokers to change people’s plans on the federal Affordable Care Act marketplace following mounting consumer complaints about unauthorized changes.
      • “On Friday, the CMS announced agents can’t make changes to a consumer’s enrollment in the federal exchanges unless they’re already associated with that consumer. If agents and brokers are unassociated, they have to take additional steps to update a consumer’s marketplace enrollment — even with that consumer’s consent, according to the notice.
      • “Unassociated brokers will have to have a three-way call with the beneficiary and the marketplace’s call center, or have the beneficiary change their enrollment themselves through HealthCare.gov or another approved portal. The changes, which don’t apply to the 18 states (and Washington, D.C.) that run their own insurance marketplaces, took effect immediately.”
    • Per an HHS press release,
      • “The Biden-Harris Administration’s Kids Online Health and Safety Task Force, co-led by the U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Department of Commerce’s (DOC) National Telecommunications and Information Administration (NTIA), released a new report today with recommendations and best practices for safer social media and online platform use for youth. The recommendations in the report, Online Health and Safety for Children and Youth: Best Practices for Families and Guidance for Industry, underscore the Administration’s efforts to address the ongoing youth mental health crisis and support the President’s Unity Agenda for the nation. Task Force members also committed to future actions, including providing more resources for kids, teenagers and families, guidance for pediatricians and conducting more research.”
    • Healthcare Innovation lets us know,
      • “On July 17, the Office of the National Coordinator for Health IT (ONC) released the agency’s latest Data Brief and Quick Stat. According to ONC’s survey findings, 64 percent of U.S. hospitals plan to participate in TEFCA™, the Trusted Exchange Framework and Common Agreement. The agency notes that “This is an increase over 2022, when 51 percent of U.S. hospitals said they planned to participate.”
      • “Other findings:
        • “Approximately 7 out of 10 hospitals that participated in national networks or health information exchanges (HIEs) planned to participate in TEFCA, compared to 4 out of 10 hospitals that did not participate in either type of network.
        • “Hospitals with more resources, such as those that are larger, non-critical access, and affiliated with health systems, indicated greater awareness and had higher levels of planned participation in TEFCA when compared to smaller, critical access, and independent hospitals with fewer resources.
        • “The percent of hospitals that were aware of TEFCA but did not know if they would participate decreased from 23% to 9% from 2022 to 2023.”
      • FEHBlog Note — TEFCA is the government’s backbone for the healthcare electronic medical records system.

    From the public health and medical research front,

    • The Washington Post reports,
      • “More than 40 percent of women said they skipped or delayed a screening recommended by a health professional, according to a recent survey by Gallup for the medical technology company Hologic.
      • “In the survey of 4,001 adult women across the United States, 90 percent of respondents agreed that it is important to get regular preventive health screenings for cancer, heart disease, sexually transmitted infections and other key health conditions. But 43 percent also said they skipped or delayed a recommended screening, including for breast cancer, cervical cancer and colorectal cancer.
      • “The respondents cited multiple reasons for doing so: anxiety about medical tests, pain concerns, cost, lack of time or not believing a screening was necessary.
      • “In addition, only 42 percent of the participants said they were “very confident” about which health screenings they needed. Many women also had trouble finding pertinent information, with 31 percent of Gen Z women saying it was hard for them to find relevant health information.”
    • Medscape tells us,
      • “Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.
      • “A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.” * * *
      • “Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” said Millennium Health Chief Clinical Officer Angela Huskey, PharmD, in a press release.”

    From the U.S. healthcare business front,

    • Fierce Healthcare names the most influential minority executives in healthcare. Kudos to that group.
    • Beckers Payer Issues points out recent physician hires to executive roles at payer organizations.
    • Fierce Healthcare informs us,
      • “Embattled Steward Health Care has canceled auctions for its hospitals in Ohio and Pennsylvania after it did not receive qualified bids for those facilities, according to a court filing.
      • “The health system said in a document filed Sunday with bankruptcy court in Texas that it is working to determine alternatives for those facilities and expects to make an announcement at a later date. It had initially set a bid deadline for June 24 for these assets, which was later pushed back to July 15.
      • “Steward filed for chapter 11 bankruptcy in the Southern District of Texas in May.”
    • Fierce Healthcare also relates,
      • “Cigna has created a new impact fund that aims to address health disparities commonly impacting local communities.
      • “The insurer’s philanthropic arm, the Cigna Group Foundation, will operate the Cigna Group Health Equity Impact Fund. Through the program, Cigna will contribute $9 million over the next three years to tackle disparities and inequities across priority states.
      • “According to an announcement, the program will initially focus in Houston, Texas and Hartford, Connecticut. By drilling down to these specific communities, Cigna said it can “optimize” the level of assistance needed to put toward the unique equity challenges they’re facing.”

    Weekend update

    David Ermer–CDC, Congress, Medicare, U.S. Healthcare–

    From Washington, DC,

    • The House Oversight and Accountability Committee will hold its third hearing on prescription benefit managers this Tuesday July 23 at 10 am.
    • Over the past two weeks —
      • Tammy Flanagan, writing in Govexec, offered tips on creating a smooth transition from federal employee to federal annuitant.
      • Kevin Moss, writing in the Federal Times, discusses the pros and cons of paying for both FEHB and Medicare Part B coverage. He summarizes as follows:
        • “The main reason to not consider enrolling in Part B is the cost of the extra premium. For federal annuitants that are not subject to IRMAA, adding Part B will most likely be worth it. Having Part B gives you the option to see doctors outside of the plan network and if you enroll in an FEHB plan that waives some out-of-pocket costs or consider MA plans offered by FEHB plans, you could see a reduction in your total healthcare spending.
        • “For federal annuitants that are subject to IRMAA, most of the benefits of enrolling in Part B will erode by having to pay more. This is especially true if your income places you in the second tier or higher of IRMAA and you expect that level of income throughout your retirement.”
      • The FEHBlog points out that the IRMAA tax is temporary because incomes usually subside in retirement below the IRMAA relatively high thresholds while the Medicare Part B late enrollment penalty is forever.

    From the public health and medical research front,

    • Fortune Well lets us know,
      • “As U.S. health officials investigate a fatal outbreak of listeria food poisoning, they’re advising people who are pregnant, elderly or have compromised immune systems to avoid eating sliced deli meat unless it’s recooked at home to be steaming hot.”
      • “The U.S. Centers for Disease Control and Prevention didn’t mandate a food recall as of early Saturday, because it remains unclear what specific products have been contaminated with the bacteria now blamed for two deaths and 28 hospitalizations across 12 states. This means the contaminated food may still be in circulation, and consumers should consider their personal risk level when consuming deli meats.
      • “Federal health officials warned on Friday that the number of illnesses is likely an undercount, because people who recover at home aren’t likely to be tested. For the same reason, the outbreak may have spread wider than the states where listeria infections have been reported, mostly in the Midwest and along the U.S. eastern coast.
      • “The largest number known to get sick — seven — were in New York, according to the CDC. The people who died were from Illinois and New Jersey.
      • “Of the people investigators have been able to interview, “89% reported eating meats sliced at a deli, most commonly deli-sliced turkey, liverwurst, and ham. Meats were sliced at a variety of supermarket and grocery store delis,” the CDC said.”
    • The Wall Street Journal reports,
      • “How much drinking is bad for you?
      • “Though more people are calling themselves sober-curious or are trying zero-proof replacements for alcohol, drinking is a regular part of social life for most of us. A coupe of champagne can add fun to a celebration. A cocktail can take the edge off a tough day. And a cold beer can liven up a sports game. 
      • “Yet scientists’ warnings about the potential health problems of even small amounts of alcohol are growing more dire. For moderate drinkers, it can be hard to know what’s actually OK to consume: Is two a day that much worse than one? Are two drinks over a week the same as two in a day? 
      • “Averaging no more than about one drink a day is relatively low risk, according to scientists who study alcohol. They warn the risk of cancer rises significantly when you exceed that. Studies have suggested that alcohol contributes to about half a dozen types of cancers, including breast and colorectal, as well as heart and liver disease, among other conditions.” 
    • MedPage Today reports,
      • “U.S. health officials on Friday said a new study in Michigan suggested the bird flu virus is not causing asymptomatic infections in people, while also announcing two new human cases in Colorado.
      • “Last month, the Michigan Department of Health and Human Services launched a study of workers who were around cows sickened by the bird flu. The researchers drew blood from 35 people.
      • “One goal was to determine if there were people who never had any symptoms but did have evidence of past infections. None of the blood testing showed antibodies that would indicate infections with the highly pathogenic avian influenza (HPAI) A(H5N1) virus circulating among dairy cattle and poultry, the CDC reported on Friday.
      • “The lack of antibodies to avian influenza A(H5N1) virus suggests these people were not previously infected with an avian influenza A(H5N1) influenza virus,” the agency said. “These data are consistent with other dataopens in a new tab or window demonstrating the seroprevalence to HPAI A(H5N1), even among workers with known exposures, is low.”
      • “Many of the workers did show antibodies to seasonal flu, which was used as a control virus in the study. Researchers will continue to sample workers, and the data will be analyzed and prepared for a peer-reviewed publication, the CDC said.
    • Per Medscape,
      • “One in five children (20.2%) who have an older sibling with autism spectrum disorder (ASD) are likely to be diagnosed with the disorder as well, according to a study published in Pediatrics.
      • “When a baby had more than one older sibling with autism, the family recurrence rate rose to 36.9%, the study found. * * *
      • “Dr Ozonoff’s team found that sex and race played a part in likelihood of recurrence. Younger siblings of females with ASD were much more likely to develop the disorder (34.7%) than siblings of boys (22.5%). And male younger siblings were more likely to have ASD than girls (25.3% vs 13.1%).”