Weekend Update

Rx coverage

Weekend Update

David Ermer–Congress, Medical / Rx research, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Both Houses of Congress will be taking their August recess until September 9.
  • Per Senate press releases,
    • “Sen. Bernie Sanders (I-Vt.), Chairman of the Senate Committee on Health, Education, Labor, and Pensions (HELP), today introduced legislation to address the long COVID crisis that is affecting more than 22 million adults and 1 million children across the United States – and millions more around the globe. The Long COVID Research Moonshot Act of 2024 provides $1 billion in mandatory funding per year for 10 years to the National Institutes of Health (NIH) to support long COVID research, the urgent pursuit of treatments, and the expansion of care for patients across the country.”
    • “Read the bill text, here. 
    • “Read the summary, here. 
    • “Read the section-by-section, here.”
  • and
    • “U.S. Senator Angus King (I Maine) is introducing legislation to ensure Maine people have access to affordable and preventative mental health and behavioral healthcare services. The Primary and Behavioral Healthcare Access Act would require private insurance plans to cover three annual primary care visits, and three annual outpatient mental health or outpatient substance use disorder treatment visits, without charging a copayment, coinsurance, or deductible-related fee. This commonsense legislation would cover private insurance under Affordable Care Act (ACA) and employer-sponsored plans.
    • “Congresswoman Lauren Underwood (D-IL) has introduced a companion bill in the House of Representatives.”
  • Per an HHS press release,
    • “On August 1, 2024, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a civil monetary penalty of $115,200 collected against American Medical Response (AMR), a provider of emergency medical services across the United States. The civil monetary penalty was the result of an investigation based on a complaint that AMR had failed to provide a patient with timely access to their medical records. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule’s right of access provisions require that individuals or their personal representatives have timely access to their health information (within 30 days, with the possibility of one 30-day extension) and for a reasonable, cost-based fee.” * * *
    • “View the Notice of Proposed Determination and Notice of Final Determination – PDF.
    • “Read about OCR’s guidance on the HIPAA right of access.”

From the public health and medical research front,

  • NPR Shots lets us know,
    • “A key protein that helps assemble the brain early in life also appears to protect the organ from Alzheimer’s and other diseases of aging.
    • “A trio of studies published in the past year all suggest that the protein Reelin helps maintain thinking and memory in ailing brains, though precisely how it does this remains uncertain. The studies also show that when Reelin levels fall, neurons become more vulnerable.
    • “There’s growing evidence that Reelin acts as a “protective factor” in the brain, says Li-Huei Tsai, a professor at MIT and director of the Picower Institute for Learning and Memory.
    • “I think we’re on to something important for Alzheimer’s,” Tsai says.”
  • The Washington Post informs us,
    • “People living with chronic pain are more likely than their peers without pain to need mental health treatment, yet less likely to get it, a new analysis suggests.
    • “The study, published in the journal PAIN, relied on data from the 2019 National Health Interview Survey, which tracked population-wide health in the United States by surveying a nationally representative sample of about 32,000 adults.”
  • The American Medical Association tells us about what doctors wish their patient knew about “summer finger bumps.”

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “Urgent care or ER? With ‘one-stop shop,’ hospitals offer both under same roof.
    • “Hospitals are partnering with a private-equity-backed company to offer emergency and urgent care in one building. Patients may not realize prices vary between the services.”
      • “UF Health is one of about a dozen health systems in 10 states partnering with Intuitive Health to set up and run hybrid ER-urgent care facilities. More are in the works; VHC Health, a large hospital in Arlington, Va., plans to start building one this year.
      • “Intuitive Health was established in 2008 by three emergency physicians. For several years, the company ran independent combination ER-urgent care centers in Texas.
      • “Then, Altamont Capital Partners, a multibillion-dollar private equity firm based in Palo Alto, Calif., bought a majority stake in Intuitive in 2014.
      • “Soon after, the company began partnering with hospitals to open facilities in states including Arizona, Delaware, Indiana and Kentucky. Under their agreements, the hospitals handle medical staff and billing while Intuitive manages administrative functions — including initial efforts to collect payment, checking insurance and taking co-pays — and nonclinical staff, said Thom Herrmann, CEO of Intuitive Health.”
  • Forbes tells us,
    • “CVS Health is rolling out a new store format in several U.S. markets that includes Oak Street Health’s senior-focused health centers “side-by-side” a pharmacy, the healthcare company said.
    • “What began as a pilot project in Houston last year is now beginning a national expansion, starting with three Chicago locations that are among about 25 Oak Street Health centers that will be alongside a CVS pharmacy in reformatted former drugstores by the end of 2024. The new format is being deployed this year in several other markets including New York City, Dallas-Fort Worth and Columbus, Ohio. Another 11 of the new formats with Oak Street health centers alongside a pharmacy will open in 2025.”
  • Per Fierce Pharma,
    • “As growth in Vertex’s cystic fibrosis portfolio buoys the company amid the launch of gene therapy Casgevy, the company is feeling confident enough to boost its revenue outlook for the year.
    • “After collecting $2.65 billion in second-quarter revenues, representing a 6% uptick from last year’s second quarter, Vertex lifted its full-year sales guidance to a range of $10.65 billion to $10.85 billion. The new forecast adds $100 million on either end of the company’s prior guidance.
    • “The new numbers reflect expectations for continued cystic fibrosis growth and Casgevy’s uptake in its approved indications and markets, the company said in a release.
  • Per HR Dive,
    • “U.S. employers are planning for 3.5% raises in 2025, according to Payscale’s most recent salary budget survey. 
    • “The anticipated salary increase rates vary by industry, Payscale found. On the upper end, government, and engineering and science workers will see raises above 4.5% and 4.2%, respectively. Meanwhile, retail, customer service and education workers can expect raises of just 3.1%, Payscale said.
    • “Given the stabilization of inflation and the easing of labor market conditions, we’re seeing a slight reduction in planned salary increases for 2025, though figures are still above the 3% pre-pandemic baseline that employees have come to expect,” said Ruth Thomas, chief of research and insights at Payscale, in a statement.”

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.

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.”

Friday Factoids

David Ermer–CDC, COVID-19, Cybersecurity, Federal employment benefits, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Govexec reports,
    • “The Office of Personnel Management on Thursday encouraged federal agencies to conduct their own analyses to correct potential pay disparities within their workforces.
    • “In 2021, President Biden signed a sweeping executive order aimed at improving diversity, equity, inclusion and accessibility at federal agencies, including provisions requiring the creation of a governmentwide strategic plan on the issue and that the OPM director consider banning the use of past salary history to set pay during the hiring process. OPM followed through on that edict earlier this year.
    • “In a memo to agency heads Tuesday, acting OPM Director Ron Shriver highlighted OPM’s governmentwide study of pay gaps in the federal workforce, which found that in 2022, the gender pay gap was 5.6%, meaning women on average earned about 94 cents for every dollar male federal workers earned. The figure marks a slight improvement over the 2021 gender pay gap of 5.9% and is significantly better than the nationwide gender pay disparity of 16%.
    • “Shriver directed that federal agencies that operate their own pay systems governing at least 100 employees must now conduct the same review of pay policies that OPM did for the General Schedule, Federal Wage System and Senior Executive Service workforces. And he encouraged all agencies to conduct their own gap analyses to search for pay disparities along gender or racial and ethnic lines affecting their own workforces, regardless of pay system.”
  • HHS’s Administration for Strategic Preparedness and Response announced,
    • “awards totaling $18.5 million to two U.S. companies to expand the nation’s manufacturing of key starting materials and active pharmaceutical ingredients needed to make essential medicines. The awards are the first through ASPR’s BioMaP-Consortium, a public-private partnership established in January 2024.
    • “ASPR is committed to expanding our nation’s domestic manufacturing infrastructure,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “Today’s announcement advances our efforts to build resilient U.S.-based supply chains for pharmaceutical ingredients and mitigate risk and reliance on foreign supplies. Having this capability in the U.S. is critical for our emergency preparedness.”
    • “California-based Antheia will receive approximately $11 million to support U.S.-based production of pharmaceutical ingredients, and Virginia-based Capra Biosciences will receive approximately $7.5 million to leverage its bioreactor platform to manufacture three active pharmaceutical ingredients.” 
  • Mercer Consulting projects that for 2025 the health flexible spending account contribution limit will increase by $100 from $3200 to $3300 and the carryover limit will increase from $640 to $660.”

From the public health and medical research front,

  • The CDC tells us today
    • Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in many areas.
    • COVID-19
      • Many 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+. CDC will continue to closely monitor trends in COVID-19 activity.
    • Influenza
    • RSV
      • Nationally, RSV activity remains low.
    • Vaccination
  • The University of Minnesota’s CIDRAP notes,
    • Along with the CDC’s report of high wastewater levels of SARS-CoV-2, WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, notes that detections are in the high category, with no significant trend up or downward over the past 3 weeks. It said all regions of the country are in the high category, except for the Midwest, which is at the medium level.
  • STAT News adds,
    • “STAT spoke with experts in infectious disease, virology, and public health to find out what people need to know about this summer’s Covid surge.
    • “One key message: Despite the increase in cases, the protection people have built up thanks to rounds of vaccination and prior infections is still sparing the vast majority of people from severe illness.”
    • “Once you really get a decent immunity, you may get the virus again, but you’re probably not going to get very sick from it,” said Aaron Glatt, chair and professor of medicine at Mount Sinai South Nassau.”

From the U.S. healthcare business front,

  • The American Hospital Association News lets us know,
    • “A non-malicious global technology outage that began in the early morning of July 19 is continuing to affect many industries and is having varying effects on hospitals and health systems across the country. The outage was caused by a faulty software update issued by the cybersecurity firm CrowdStrike, which is widely used by businesses and government agencies that run on Microsoft computers. 
    • “CrowdStrike is actively working with customers impacted by a defect found in a single content update for Windows hosts,” the organization posted on its website early today. “Mac and Linux hosts are not impacted. This is not a security incident or cyberattack. The issue has been identified, isolated and a fix has been deployed. We refer customers to the support portal for the latest updates and will continue to provide complete and continuous updates on our website. We further recommend organizations ensure they’re communicating with CrowdStrike representatives through official channels.
    • “CrowdStrike’s webpage includes more information about the issue and workaround steps organizations can take. The Cybersecurity and Infrastructure Security Agency also posted an alert on the incident.” 
  • The Hill reports,
    • “After peaking during the COVID-19 pandemic, physician burnout has dipped under 50 percent for the first time in four years, but doctors say working conditions in the medical field remain far from ideal. 
    • “A survey published by the American Medical Association (AMA) this month found that 48.2 percent of physicians in 2023 experienced at least one symptom of burnout, down nearly 15 percent from when this metric peaked in 2021. 
    • “Reported job satisfaction rose from 68 percent to 72.1 percent between 2022 and 2023, while job stress dropped in the same time frame, going from 55.6 percent to 50.7 percent. 
    • “It’s good news and it’s bad news,” Steven Furr, president of the American Academy of Family Physicians, told The Hill. “It’s good news that the numbers have gone down but still they’re higher than what we’d like them to be.” 
    • “The AMA has tracked physician burnout rates since 2011 along with the Mayo Clinic and Stanford Medicine. Prior to the pandemic, burnout rates ranged from 43.9 percent in 2017 to 54.4 percent in 2014.” 
  • mHealth Intelligence points out,
    • “Telehealth visits at United States hospitals skyrocketed during the COVID-19 pandemic, rising 75 percent between 2017 and 2021; however, adoption was uneven, with hospitals citing challenges to electronic health information exchange, according to a new study.
    • “Published in the Journal of General Internal Medicine, the study examined US hospitals’ adoption of telehealth before and during the pandemic, aiming to provide targeted policy implications.” * * *
    • “The researchers found that telehealth encounters increased from 111.4 million in 2020 to 194.4 million in 2021, a 75 percent jump. Additionally, hospitals offering at least one form of telehealth increased from 46 percent in 2017 to 72 percent in 2021.
    • “However, the adoption was not uniform across hospitals. Larger, nonprofit, and teaching hospitals were more likely to adopt telehealth than their counterparts. Notably, the study found no significant telehealth adoption disparities between hospitals in urban and rural areas.
    • “Further, more than 90 percent of hospitals allowed patients to view and download medical records, but only 41 percent permitted online data submission. One-quarter (25 percent) of hospitals identified certified health IT developers, such as EHR vendors, as frequent culprits in information blocking.
    • “Most US hospitals also reported challenges in exchanging health information electronically, with 85 percent citing barriers related to vendor interoperability.
    • “The researchers concluded that comprehensive policy interventions are necessary to address telehealth adoption and other IT-related disparities across the US healthcare system.”

Monday Roundup

David Ermer–CDC, Congress, COVID treatment, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Reuters reports,
    • “Democratic U.S. Senate aides will meet with Novo Nordisk executives on Tuesday to discuss fallout from its decision to stop selling one of its long-acting insulins in the country, two sources familiar with the meeting told Reuters.
    • “Novo Nordisk (NOVOb.CO), opens new tab will meet with the aides for Senators Jeanne Shaheen, Raphael Warnock, and Elizabeth Warren. In April, the lawmakers wrote to the company expressing alarm at its decision, announced in November, that it would permanently discontinue Levemir by the end of 2024.
    • “Novo said it has given patients enough time to switch to other options, according to a May letter seen by Reuters. The company is unaware of plans for drug manufacturers to produce a biosimilar version of the insulin, the letter said, adding Novo would not assert any patent against such a version.
    • “The sources declined to be named citing the sensitivity of the matter.”
  • STAT News lets us know,
    • “For now, the doctor groups are lobbying [Congress] in unison toward the same goal of increasing the pot of money for physician services, which stood at about $71 billion in 2022, or 16% of Medicare fee-for-service spending. A Medicare spokesperson said that number is expected to reach about $90 billion this year. Doctors would also like to get credit for saving money by keeping patients out of the hospital.
    • “Those demands would pit doctors against others in the health care system, including hospitals, because Congress typically requires that increases in Medicare spending be paid for by cuts elsewhere in the program. That’s a heavy lift. Congress has been considering equalizing certain Medicare payments between hospitals and physicians’ offices to save money, but that site-neutral policy has faltered.
    • “That’s not the only thing working against doctors. If Congress increases spending on physician services, seniors’ Medicare Part B premiums will go up, according to the nonpartisan research arm of Congress. Congress could prevent premiums from increasing, but that would add to the government tab.
    • “For those reasons, doctor lobbyists privately doubt Congress will meaningfully increase physician pay rates overall, leaving doctors to fight over how a fixed sum of money should be split up.
    • “Courtney Savage, founder of Savage Health Policy, said she sees signs of trouble ahead for specialists. Republicans and Democrats in the Senate want to boost primary care pay. Sens. Bill Cassidy (R-La.) and Sheldon Whitehouse (D-R.I.) unveiled a plan to “improve the adequacy of pay for primary care providers in Medicare.” Two days later, Senate Finance Committee Chair Ron Wyden (D-Ore.) and the committee’s ranking Republican, Idaho’s Sen. Mike Crapo, published their plan to improve chronic care, which would likely favor primary care doctors, too.”
  • In this regard, the American Hospital News tells us,
    • The AHA July 15 commented to Sens. Sheldon Whitehouse, D-R.I., and Bill Cassidy, R-La., responding to a request for information based on the Pay PCPs Act, legislation designed to improve support and pay for primary care providers. The AHA expressed concerns that its proposed hybrid per-member-per-month and fee-for-service payment structure in the physician fee schedule for primary care could result in payment cuts, and that there may be variation in the PMPM depending on the type of provider. The bill also has language implying that there is latitude for the PMPM to not be risk-adjusted and possibly restrict what could be included in the risk adjustment, AHA said. 
    • The AHA voiced support for a provision in the legislation that would reduce beneficiary cost-sharing for primary care services by 50% under the hybrid payment model. The association also shared principles for Congress to consider when designing alternative payment models to make participation more attractive for potential participants.
  • Per Axios,
    • “The Centers for Medicare and Medicaid Services last week proposed creating three new payment codes that would allow physicians to get paid for incorporating digital therapies into patients’ mental health treatment, starting in 2025. 
    • “The codes would only apply to products approved by the Food and Drug Administration.
    • “Insurers have so far been reluctant to pay for apps, video games and other therapeutic software. There isn’t long-term data on the effectiveness, and differences in the therapies make it difficult to standardize billing.
    • “The first company to get FDA clearance for a digital therapy, Pear Therapeutics, declared bankruptcy last year after struggling to secure insurance coverage for its products.”

From the public health and medical research front,

  • The AHA News points out,
    • “The Centers for Disease Control and Prevention July 14 announced four confirmed human cases of H5N1 bird flu among farm workers who were working at a Colorado poultry facility. The agency is also aware of a fifth presumptive-positive case, which is pending confirmation. All of the workers who tested positive reported having a mild illness, with symptoms that include conjunctivitis, eye tearing, fever, chills, coughing, sore throat and a runny nose. The CDC said they believe a risk to the public remains low.” 
  • STAT News adds,
    • The announcement of the fourth [H5N1 bird flu] case, on the eve of the July 4 holiday, led Adam Kucharski, the co-director of the Centre for Epidemic Preparedness & Response, at the London School of Hygiene and Tropical Medicine, to ask on the social platform X: “What’s the plan?”
    • Kucharski posed a bunch of hypotheticals — What if there are clusters of cases? Cases among people who haven’t had contact with cows? Cases exported to other countries? — to convey the point that a mere four years after the start of the worst pandemic since the 1918 Spanish Flu, the world does not appear to be grappling with the fact that H5 virus spreading in cows could lead to H5 virus spreading in people.
    • “What, here in 2024, is the plan for dealing with an outbreak of a potentially pandemic pathogen like H5N1?” he asked.”
  • Medscape notes,
    • “Parkinson’s disease (PD) and dementia with Lewy bodies are currently defined by clinical features, which can be heterogeneous and do not capture the presymptomatic phase of neurodegeneration.
    • “Recent advances have enabled the detection of misfolded and aggregated alpha-synuclein protein (synucleinopathy) — a key pathologic feature of these diseases — allowing for earlier and more accurate diagnosis. This has led two international research groups to propose a major shift from a clinical to a biological definition of the disease.
    • “Both groups emphasized the detection of alpha-synuclein through recently developed seed amplification assays as a key diagnostic and staging tool, although they differ in their approaches and criteria.” * * *
    • “Commenting for Medscape Medical News, James Beck, PhD, chief scientific officer at the Parkinson’s Foundation, said the principle behind the proposed classifications is where “the field needs to go.”
    • “Right now, people with Parkinson’s take too long to get a confirmed diagnosis of their disease, and despite best efforts, clinicians can get it wrong, not diagnosing people or maybe misdiagnosing people,” Beck said. “Moving to a biological basis, where we have better certainty, is going to be really important.”
  • The New York Times reports, “Families pay thousands of dollars to store their children’s stem cells with the hope of a healthier future. But the cells are rarely useful, and sometimes contaminated.” No bueno.
  • A STAT News journalist observes,
    • If you read Derek Lowe — and come on, you must read the bearded chemist who has been blogging about pharma for two decades — you’ve already thought about ibuzatrelvir, Pfizer’s potential heir to Paxlovid, which would be given as a single pill and potentially without that metallic taste.
    • “I read this eagerly, but I had another question that I asked virologist Michael Mina when he posted Derek’s article on X. How do we test it?
    • “Plenty of people still get Covid and die from it. But I’ve been watching clinical trials of Paxlovid and other antivirals. And these drugs keep failing in studies. Even Paxlovid worked best when it was given to high-risk people who have not been vaccinated. Shionogi’s Paxlovid follow-up recently failed in a large study.“Plenty of people still get Covid and die from it. But I’ve been watching clinical trials of Paxlovid and other antivirals. And these drugs keep failing in studies. Even Paxlovid worked best when it was given to high-risk people who have not been vaccinated. Shionogi’s Paxlovid follow-up recently failed in a large study.
    • “It’s very hard to prove an antiviral drug works, a problem that has long dogged Tamiflu. The benefit only shows up if people are at very high risk, or if the study is very big. Otherwise, it just appears the drug is reducing symptoms a very tiny bit.
    • “On this, David Boulware of the University of Minnesota had one perspective: Shionogi’s drug failed because regulators wanted its study to contain too few high-risk patients. But my suspicion is that getting better Covid drugs will be less a problem of chemistry than of clinical trials. This is part of why we don’t have more monoclonal antibodies against new strains. Paxlovid sales have come in higher than many analysts were expecting so far this year. Maybe that will encourage drug.” companies to solve this problem.
  • The Washington Post and Consumer Reports explain “what to do when you need medical care fast,”
    e.g., self-triage.
  • Per MedPage Today,
    • “A mammography screening decision aid with information about the benefits and harms of screening increased the percentage of average-risk women in their 40s who wanted to delay mammography, according to a national online survey.
    • “Before viewing the decision aid, 27% of women ages 39 to 49 preferred to delay screening. The decision aid raised that percentage to 38.5%, reported Laura Scherer, PhD, of the University of Colorado in Aurora, and colleagues.
    • “The survey also showed a narrower majority of women preferred to undergo mammography at their current age after viewing the decision aid (57.2% vs 67.6% beforehand) and more preferred to wait until age 50 (18% vs 8.5%).
    • “As to what information shifted their view, 37.4% of women surveyed said they found the information about overdiagnosis in the decision aid “surprising,” and 28.1% said it differed from what their doctor had told them, Scherer and colleagues reported in the Annals of Internal Medicine.
    • “While the U.S. Preventive Services Task Force (USPSTF) recommends biennial screenings starting at age 40 years — compared with a previous recommendation that screening begin at 50 — it “endorses informed choice and shared decision making at all levels of its recommendations,” Scherer’s group wrote.
    • “However, “a lack of language promoting informed choice in the guideline itself may create confusion among clinicians about whether they should discuss both screening benefits and harms with patients or instead provide only information that maximizes screening uptake,” they added.”

From the U.S. healthcare business front,

  • AIS Daily reports,
    • “Blue Shield of California caught the attention of the industry last August when it announced a switch to a pharmacy benefits model using five vendors. While some insurers and plan sponsors have considered a similar move following Blue Shield’s revelation, benefits consultants tell AIS Health that most payers continue to have a traditional arrangement where one PBM handles all pharmacy-related activities. They add that Blue Shield’s so-called unbundled approach could be difficult to manage and may not achieve significant cost savings.”
  • Per Fierce Pharma,
    • “While patent cliffs are looming for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a research note from Morgan Stanley.
    • “In the July 11 report, the analysts calculate that products losing exclusivity through 2030 are generating a combined $183.5 billion in annual sales, with Amgen, Bristol Myers Squibb and Merck facing the most exposure of their revenue.
    • “Meanwhile—citing company financial reports and data from Visible Alpha and FactSet—Morgan Stanley estimates that Big Pharma has $383.1 billion of firepower available for dealmaking. The companies sitting on the most dry powder are Johnson & Johnson, Merck and Novo Nordisk, the analysts said.
    • “We continue to see the conditions as generally favorable for bolt-on M&A as large-cap pharma companies have balance sheet capacity and a need to acquire outer-year revenue,” the Morgan Stanley team, led by Terence Flynn, Ph.D., wrote.”
  • BioPharma Dive offers a chart with “Years of expiration for principal patents protecting the top 30 pharmaceutical products by 2023 sales.”
  • Beckers Hospital Review discloses the gender breakdown of physicians across the fifty states and DC.
  • Per MedCity News, “Walgreens’ Finances Are in Dire Straits — But All Hope Is Not Lost. Walgreens’ financial performance is still rocky, but experts agree there is a good chance that CEO Tim Wentworth can lead the company to recovery. To make this happen, Walgreens will have to let go of its retail clinic dreams and focus more on making its core pharmacy business as strong as possible.”

Weekend Update

David Ermer–Congress, Medical / Rx research, Obesity, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Fierce Healthcare discusses a Senate Special Committee on Aging hearing about healthcare price transparency held last Thursday July 11.
    • “If consumers or business departments received a major charge on their monthly statements with no pricing breakdown or itemized receipts, many would demand more information if not outright refuse to pay.
    • “But that’s not the case in healthcare, where unexpected fees billed from insurers and hospitals and multiplicative markups are delivered after the fact and with little explanation.
    • “That was the message senators heard loud and clear during a Thursday morning hearing of policy researchers and purchasers of commercial insurance for employees and union members.” * * *
    • [Ranking Member Sen. Mike} Braun [R Ind.] kept the legislative focus squarely on price transparency, highlighting a bipartisan package he brought with Sens. John Hickenlooper, D-Colorado; Bernie Sanders, I-Vermont; Chuck Grassley, R-Iowa; and Tina Smith, D-Minnesota, earlier this year.
    • That bill, the Health Care PRICE Transparency Act 2.0 [S. 1130], received the explicit support of multiple witnesses and other price transparency advocacy groups whose written comments were entered into the hearing’s record. It would impose data sharing standards, require negotiated rates and cash prices on machine-readable files rather than estimates, increase maximum annual noncompliance penalties and give group health plans the right to audit and review claims data.

From the public health and medical research fronts,

  • MedPage Today discusses four exceptional papers from JAMA Open Forum.
    • Item 1: Smartphone App Decreases Distracted Driving
    • Item 2: Vaping and Secondhand Nicotine Exposure in Kids
    • Item 3: New Data Adds Confidence to RSV Vaccine Safety During Pregnancy
    • Item 4: Mental Health Care Access Via Telehealth Decreased After the COVID Emergency Period.
  • The Washington Post points out
    • “A study published in the journal Alcohol: Clinical & Experimental Research looked at the reasons young adults give for not drinking, which researchers say could help in crafting public health messaging aimed at reducing alcohol abuse.
    • “Researchers focused on 614 participants who took online surveys about their alcohol use from mid-February to mid-May 2022. Participants were an average of 21.5 years old, and the majority were White (64.5 percent) and male (54.2 percent). About 65 percent were college students.
    • “Among the respondents, 49.9 percent said they were moderate drinkers, with 31.5 percent reporting binge drinking five to nine drinks in a row in the prior two weeks and 18.6 percent reporting “high-intensity drinking” of 10 or more drinks on a day in the previous two weeks, researchers at the University of Michigan’s Institute for Social Research and Texas State University report. The study was funded by the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse.”
  • The Wall Street Journal warns,
    • “With their fitness-influencer endorsements and wellness sheen, energy drinks have become more appealing to women. They’ve also become a go-to for teenage girls and young women with eating disorders.  
    • “Overconsumption of low-cal, highly caffeinated energy drinks is on the rise among young women with unhealthy eating and exercise habits, say doctors at more than a dozen of the nation’s top hospitals and eating-disorder treatment centers. Taking in too much caffeine can cause serious health problems, especially for people who aren’t eating enough, doctors say.   
    • “Brands like Celsius and Alani Nu pitch themselves as fitness aids, and, in the case of Celsius, claim to boost metabolism and burn fat. Attaining a toned body, the brands’ social-media posts suggest, looks as easy as sipping a can of the sparkling sugar-free beverages before a sweat sesh.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “The rural hospital collaborative in North Dakota has secured two value-based contracts with commercial insurers and more are expected this year, building momentum for those considering similar alliances.
    • “Cibolo Health in October created the Rough Rider High-Value Network comprised of 23 critical access hospitals in North Dakota. The rural hospital advisory firm has since helped launch a similar venture in Minnesota and is in early talks to expand the model in several other states, CEO Nathan White said.
    • “The Rough Rider network inked a Medicare shared savings contract with CVS Health and a contract with Blue Cross Blue Shield of North Dakota that includes quality-based payments and shared savings, White said. Other payers are interested in Medicare Advantage and accountable care organization contracts, he added.”
  • Healthcare Dive lets us know,
    • “Geisinger will begin a $880 million expansion of its Danville, Pennsylvania-based medical center next year, with plans to include a new 11-story medical tower, the system said Tuesday.
    • “The project will include a larger emergency department, expanded intensive care units and operating suites, as well as private rooms for each patient.
    • “The Risant Health-owned nonprofit plans to execute the expansion in phases, with a target completion date of 2028.” 
  • HR Dive informs us,
    • “With the Great Resignation far in the rearview mirror, companies now are facing another challenge: what to do when employees stay.
    • “The U.S. quit rate — often used as a measure of turnover — has remained steadily at 2.2% for the past seven months, according to the Bureau of Labor Statistics’ Job Openings and Labor Turnover Summary released July 2. 
    • “The lull in employee exits is the perfect time for employers to work on succession planning and enhancing their value proposition, according to Lauren Geer, senior vice president and chief human resources officer of IAC, a holding company to media and internet brands including Dotdash Meredith, Care.com and Angi.
    • “It’s quieter now, but I don’t think we can rest on our laurels by any means or pat ourselves on the back for what a great job we’re doing retaining our employees,” Geer said. “Now’s the time to get the house in order, because I do think there’ll be a time when the employee market picks up.” 

Friday Factoids

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

From Washington, DC,

  • Per a Congressional press release,
    • “U.S. Sen. Chuck Grassley (R-Iowa) today applauded the enactment of the bipartisan Maternal and Child Health Stillbirth Prevention Act, a bill [(H.R. 4581)] he championed alongside U.S. Rep. Ashley Hinson (R-Iowa) and U.S. Sens. Bill Cassidy (R-La.) and Jeff Merkley (D-Ore.). The law will help curb infant mortality by enabling evidence-based stillbirth efforts to qualify for federal funding.
    • “Stillbirth prevention researchers and advocates will now have more resources to advance their work. Especially given modern medical and technological capabilities, no family should have to endure the heartbreak of a stillbirth. Many thanks to everyone – Iowa organizations in particular – who’s had a hand in advancing our commonsense bill into law. Today’s win will have a domino effect for expectant families nationwide, for years to come,” Grassley said.  
    • “Today is a huge milestone in our fight to end stillbirth, the unexpected loss of a baby after more than 20 weeks of pregnancy. I am proud to have worked with so many incredible advocates, many of whom have endured the heartbreak of stillbirth, to bring this vital legislation across the finish line and expand federal resources for stillbirth prevention. I thank President Biden for signing this bipartisan legislation into law, and I will continue my work to improve maternal health care access for more healthy moms and healthy babies,” Hinson said. “
  • Fierce Pharma lets us know,
    • “Thursday, the Senate unanimously the bipartisan Affordable Prescriptions for Patients Act [(S. 150)], which looks to limit the number of patents drugmakers can assert in litigation on individual biological products. The bill aims to fight “patent thicketing,” a tactic the branded drug industry uses to delay or thwart competition.
    • “Patent thicketing occurs when drug companies stack secondary drug patents to create a complex web of intellectual property that’s hard for generic or biosimilars developers to navigate. AbbVie, for example, was able to keep its top-selling immunology drug Humira from U.S. competition for two decades by leveraging a web of 250 patents, patient access group Patients for Affordable Drugs Now (P4ADNow) said in a press release.
    • “This long-overdue legislation would promote competition and lower prices for patients without standing in the way of innovation, and I urge my colleagues in the House to pass it as soon as possible,” bill sponsor Sen. John Cornyn, R-Texas, said in a statement. 
    • “Reining in patent thickets would create $1.8 billion in taxpayer savings over the span of a decade, the Congressional Budget Office has forecast.”
  • AXIOS reports
    • “The Biden administration on Wednesday rolled out its latest election-year initiative on women’s health, proposing standards that would require the hospital industry to invest billions in maternity care improvements to remain in Medicare. * * *
    • “Hospitals would have to keep basic resuscitation equipment available in labor and delivery rooms, document maternal health training for staff and have written policies for transferring patients to other hospitals.
    • “All hospitals offering emergency services — even if they lack an obstetrics unit — would be required to have proper protocols and supplies for emergency deliveries and other needs.
    • “Hospitals not following these standards could eventually be booted from the Medicare and Medicaid programs.”
  • The American Hospital Association News adds,
    • “An infographic released by the University of Minnesota Rural Health Research Center highlights the decline of maternity care access in rural counties across the U.S. from 2010-2022, finding that nearly 59% of rural counties did not have any hospital-based obstetric services as of 2022.
    • “Researchers categorized rural counties based on population as micropolitan (having a town of 10,000-50,000 residents) and non-core (without a town of at least 10,000 residents). They found that micropolitan counties with hospital-based obstetric care declined from about 81% in 2010 to nearly 74% in 2022. Noncore counties declined from 34% in 2010 to nearly 26% in 2022.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP tells us,
    • “Respiratory illness viruses as a whole remain at low levels, but many parts of the countries are experiencing consistent increases in COVID-19 activity, which has been trending upward from very low levels, the US Centers for Disease Control and Prevention (CDC) said today in its latest updates.
    • “Test positivity, emergency department (ED) visits, and hospitalizations—the main markers the CDC uses to gauge virus activity—are all rising, especially in both seniors and the western states. * * *
    • “The percentage of ED visits for COVID, considered an early indicator, rose 23.5% last week compared to the week before. Levels were higher in the West and the South than in the rest of the country.” * * *
    • “The dashboard at WastewaterSCAN a national wastewater monitoring system based at Stanford University in partnership with Emory University, shows SARS-CoV-2 detections at the high level, especially in the West, South, and East, with an upward trend over the past 21 days.
    • “In its latest variant update, posted on July 6, the CDC said the proportion of KP.3 detections continues to rise, up from 31.3% to 36.9% over the 2-week monitoring period. KP.3 is one of the JN.1 offshoots with mutations that allow it to better evade immunity from earlier infection or vaccination.” 
  • Per Fierce Pharma,
    • “Trials have already shown that Novo Nordisk’s semaglutide can cut the risk of cardiovascular events and kidney disease. Now a study from the University of Oxford indicates that the company’s semaglutide type 2 diabetes drug Ozempic can reduce the risk of dementia compared with another popular diabetes medicine.
    • “The research—which was designed to demonstrate if Ozempic could cause neurologic problems—showed instead that it produced a 48% decline in dementia when compared to Merck’s type 2 diabetes drug Januvia (sitagliptin).” * * *
    • “Prior studies have determined that diabetics have a greater risk of developing dementia. Those with type 2 diabetes are at an elevated risk for Alzheimer’s, according (PDF) to studies cited by the Alzheimer’s Association.” * * *
    • “Elsewhere, Lilly’s GLP-1/GIP therapy tirzepatide—which is the compound used to manufacture its type 2 diabetes drug Mounjaro and obesity treatment Zepbound—was recently shown to lower blood pressure. Researchers are still studying whether many of these benefits accrue from the treatment or from the weight loss they provide.”
  • The National Institutes of Health announced,
    • Using health data from almost 213,000 Americans who experienced reinfections, researchers have found that severe infections from the virus that causes COVID-19 tend to foreshadow similar severity of infection the next time a person contracts the disease. Additionally, scientists discovered that long COVID was more likely to occur after a first infection compared to a reinfection. The study, funded by the National Institutes of Health’s (NIH) Researching COVID to Enhance Recovery (RECOVER) Initiative, is published in Communications Medicine.
    • “About 27% of those with severe cases, defined as receiving hospital care for a coronavirus infection, also received hospital care for a reinfection. Adults with severe cases were more likely to have underlying health conditions and be ages 60 or older. In contrast, about 87% of those who had mild COVID cases that did not require hospital care the first time also had mild cases of reinfections.
    • “Reinfections were defined as having occurred at least two months after a first infection. They were found to occur most frequently when omicron variants were circulating in late 2021 and early 2022. Waning immunity and increased exposure to the coronavirus, including the highly-infectious variants, likely accounted for the uptick.
    • “Scientists also discovered that regardless of the variant, long COVID cases were more likely to occur after a first infection compared to a reinfection.”
  • The Wall Street Journal reports,
    • “Human lifespan has a limit and we might have reached it.
    • “S. Jay Olshansky, who studies the upper bounds of human longevity at the University of Illinois Chicago, believes people shouldn’t expect to live to 100. Most, he contends, will reach between 65-90.
    • “Biology is holding us back, Olshansky said. Human evolution favors growth and reproduction, not living to excessive ages. As people grow older, their cells and tissues accumulate damage. Breakdowns of one kind or another happen more frequently and get increasingly difficult to repair. Scientists believe there are likely many genes that affect lifespan. Aging is a complex process that isn’t well-understood.
    • “Olshansky knows his viewpoint isn’t popular. 
    • “The longevity business is booming. People are flocking to longevity meetings and taking compounds they hope will extend their lives. Investors are backing scientists researching techniques to reprogram cells to a younger state with the goal of restoring functions that diminish with age. Longevity influencers argue that if they can live long enough, scientific breakthroughs will keep them going indefinitely.” * * *
    • “Jan Vijg, chair of genetics at Albert Einstein College of Medicine in the Bronx, reached a similar conclusion from a different angle. He has studied the maximum verified age the oldest people died at in different countries. The maximum age at death increased gradually at least from the 1950s until the 1990s, when it appeared to plateau.
    • “He isn’t surprised that Jeanne Calment, a French woman who died in 1997 at 122, still holds the world record of the oldest verified age at death. There are now hundreds of millions more people who have reached old age under optimal conditions—benefiting from clean water, antibiotics, improved treatments for top killers such as heart disease and cancer, and healthier lifestyles. 
    • “If lifespan had no limit, some of those centenarians would have broken Calment’s record by now, he argued.” 
    • “It seems this is the end,” Vijg said.

From the U.S. healthcare business front,

  • Beckers Clinical Leadership identifies the 94 emergency departments across our country that the Emergency Nurses Association has recognized “for their commitment to quality, safety and a healthy work environment.”
  • Per Fierce Pharma,
    • “Even through an onslaught of biosimilar launches that began early last year, AbbVie’s big-selling Humira has been able to retain most of its lucrative market. Still, though, the drug’s star power is on the decline.
    • “Biosimilar manufacturer Samsung Bioeps has tracked the impact of Humira biosim launches in its latest market report, finding that Humira’s slice of the market has dropped to 82%.
    • “Sandoz’ Hyrimoz, under its Cordavis co-label, is responsible for “most biosimilar gains,” according to the report. Cordavis is CVS Health’s new biosimilar subsidiary, which launched with Hyrimoz as its first product.
    • “Back in April, CVS Caremark removed branded Humira from its national commercial formularies, causing Hyrimoz prescriptions to skyrocket, analysts at Evercore ISI noted at the time. Through April 25, Hyrimoz was responsible for 82% of Humira biosimilar prescriptions, IQVIA data revealed. The successful launch has so far pushed Sandoz to revenue gains of 6% during the first quarter.”
  • The Wall Street Journal arranged for a palliative medicine doctor to write an essay about dying at home. It’s worth a look.
    • Research suggests that 70% of Americans want to die at home. More seem to be doing so, at least partly owing to the Covid-19 pandemic. In a study of where people died in 32 countries between 2012 and 2021, published in Lancet’s eClinicalMedicine in January, the authors found a rise in home deaths in most countries, including the U.S., during the pandemic, which they largely interpreted as progress.
    • The truth is more complicated. Now, 10 years into my career as a palliative medicine physician, I know that there is much more to a “good” death than its location. Presuming a home death is a success obscures important questions about the process: Did this person die comfortably? Did their caregivers have the resources and guidance they needed? Was dying at home a choice or simply the only option?

Midweek update

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

From Washington, DC,

  • The American Hospital Association (“AHA”) News tells us,
    • “The House Appropriations Committee July 10 voted 31-25 to approve legislation that would provide $185.8 billion in funding for the departments of Labor, Health and Human Services, and Education in fiscal year 2025, an 11% cut below the prior fiscal year. * * *
    • “The bill would also prohibit any funding from being used to implement or enforce the final rule issued by the Administration relating to minimum staffing levels for long-term care facilities.
    • “The full House may consider the bill in August.”
  • The AHA News also reports on several CMS/HHS rule makings that occurred today.
    • “The Centers for Medicare & Medicaid Services July 10 released its calendar year 2025 proposed rule for the physician fee schedule. The rule proposes to cut the conversion factor by 2.8%, to $32.36 in calendar year 2025, as compared to $33.29 in CY 2024. This reflects the expiration of the 2.93% statutory payment increase for CY 2024; a 0.00% conversion factor update under the Medicare Access and Children’s Health Insurance Program Reauthorization Act; and a .05% budget-neutrality adjustment.” * * *
    • “CMS will accept comments on the proposed rule through Sept. 9.” 
      • Here is a link to the CMS fact sheet on the proposed rule plus a link to the CMS fact sheet on proposed rule’s shared savings program.
      • Per Fierce Healthcare,
        • “In statements quickly released after the proposed rule dropped, frustrated physician and industry groups contrasted the “dangerous” baseline reimbursement cut against financial pressures weighing on practices.”
    • “The Centers for Medicare & Medicaid Services July 10 issued a proposed rule that would increase Medicare hospital outpatient prospective payment system rates by a net 2.6% in calendar year 2025 compared to 2024. This includes a proposed 3.0% market basket update, offset by a 0.4 percentage point cut for productivity.” * * *
    • “CMS will accept comments on the proposed rule through Sept. 9.” 
      • Here is a link to the CMS fact sheet on the proposed rule.
      • STAT News adds,
        • “The federal government will not modify regulations that dictate how hospitals publish their prices for consumers, ignoring pleas from patient advocates who have said hospitals still are not fully complying with the 3-year-old law.
        • “The Biden administration on Wednesday proposed an annual rule that sets payment rates for hospitals. This document is where the government has in the past rolled out changes to the so-called hospital price transparency rule, but the Biden administration did not address the issue in this edition.
      • Per Fierce Healthcare,
        • “In reaction statements, industry groups like the American Hospital Association (AHA) and hospital group purchasing organization Premier said that the “inadequate” pay update proposal and called for an upward adjustment in the final version of the rule.”
    • “The Department of Health and Human Services July 10 released a proposed rule designed to improve health information sharing and interoperability. The Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule includes two sets of certification criteria designed to enable health information technology for public health and payers to be certified under the Office of the National Coordinator for Health Information Technology’s Health IT Certification Program. The criteria would improve public health response, advance value-based care delivery and focus on standards-based application programming interfaces to improve end-to-end interoperability between health care providers and public health organizations or payers. 
    • The rule proposes a new set of certification criteria to support the technical requirements included in the Centers for Medicare & Medicaid Services’ Jan. 2024 Interoperability and Prior Authorization final rule to facilitate electronic prior authorization. The proposed rule also responds to patient, provider and other communities’ concerns about patient privacy and care access by expanding exceptions and clarifying the definitions of information blocking. HHS plans to publish the notice in the Federal Register with a 60-day comment period.
  • Following up on yesterday post about the FTC interim staff report on its PBM investigation, the Wall Street Journal reports,
    • “The Federal Trade Commission is preparing to sue the largest three pharmacy-benefit managers over their tactics for negotiating prices for drugs including insulin, after a two-year investigation into whether the companies steer patients away from less-expensive medicines. 
    • “The agency plans to file lawsuits taking aim at business practices related to rebates brokered with drug manufacturers, people familiar with the matter said. The FTC is also investigating the role that insulin manufacturers play in the negotiations, one of the people said.”
  • STAT News adds,
    • “The lawsuits are expected to focus on the controversial role of rebates, according to the source, who spoke on condition of anonymity. These are paid by drugmakers to PBMs to win favorable placement on formularies, which are the lists of medicines covered by health plans. In general, drugmakers argue they must raise prices to compensate for rebates, while PBMs maintain drug companies raise prices to boost profits.”
  • Bloomberg provides context to the situation by noting
    • “States and municipalities have also filed suits against both pharmacy benefit managers and drugmakers alleging that they drove up insulin costs for public-sector health plans. Many of those cases have been consolidated in a New Jersey federal court managing the litigation.”
  • Federal New Network digs into Fed Scope and discovers, among other things, that “Nearly half of all civilian feds are new hires since 2019. Agencies hired more than 1 million federal employees since October 2019, and it’s almost an even split between competitive and excepted service.”

From the public health and medical research front,

  • The New York Times reports,
    • “A 54-year-old New Jersey woman who was the second person to receive a kidney transplanted from a genetically modified pig, and who lived with the organ for 47 days, died on Sunday, surgeons at NYU Langone Health announced on Tuesday.
    • “The patient, Lisa Pisano, was critically ill, suffering from both kidney failure and heart failure. She received the pig kidney on April 12, just eight days after implantation of a mechanical heart pump.
    • “Surgeons were forced to remove the kidney on May 29 after it was damaged by inadequate blood flow related to the heart pump. After the explantation, Ms. Pisano resumed kidney dialysis but eventually was transitioned to hospice care.
    • “Ms. Pisano made medical history as the first person with a heart pump who is known to have also received an organ transplant. Patients with kidney failure are usually ineligible to receive a heart pump because of the high risk of dying.”
    • RIP, Ms. Pisano.
  • CNN tells us,
    • “An estimated 72 million women in the United States have skipped or delayed a recommended health screening, according to a new survey. This poll, conducted by Gallupfor medical technology company Hologic, found that 90% of women acknowledged the importance of regular health screenings — but more than 40% have skipped or delayed a test.
    • “Women have trouble prioritizing their own health, the survey found, with over 60% of women responding that it was hard to make their own health a priority. The numbers are particularly striking among younger women; 74% of women in Generation Z and 70% of millennials said it was hard to prioritize their health, compared with 52% of baby boomers and 39% of the Silent Generation.
    • The journalist also interviews CNN wellness expert Dr. Leana Wen about these findings.
  • Healio informs us,
    • “[R]esearchers utilized National Violent Death Reporting System (NVDRS) data to assess the number, circumstances and characteristics of violence-related deaths in 2021.
    • “Overall, there were 68,866 fatal incidents involving 70,688 deaths that occurred in 48 states and Washington, D.C. Among the deaths:
      • 58.2% were suicides;
      • 31.5% were homicides;
      • 8.2% were deaths of undetermined intent that could have been due to violence;
      • 1.3% were deaths due to “legal intervention,” like law enforcement using deadly force in the line of duty; and
      • less than 1% were unintentional firearm deaths.
    • “Nguyen and colleagues also found that 59.2% of deaths involved firearms.
    • “Among suicide victims, when the circumstances were known (84.4%), the suicide was often preceded by mental health conditions, as 49% of victims were currently diagnosed with a mental health problem and 29.2% experienced a depressed mood at the time of death.” * * *
    • “Violence is preventable and reducing deaths in communities is possible with evidence-based approaches,” the researchers wrote.
    • “They added that such interventions can include “social-emotional learning programs, enhanced parenting skills and family relationships, treatment for persons at risk for suicide, and treatment to prevent reattempts.”
  • and
    • “Patients with chronic kidney disease or transplant should have ongoing access to telehealth to help manage care, according to results of a qualitative meta-analysis. 
    • “One group in need of telemedicine services is chronic kidney disease (CKD) and transplant patients,” Christopher D. Manko, BS, of the Geisinger Commonwealth School of Medicine in Scranton, Pennsylvania, wrote with colleagues. They added, “[P]atients need frequent appointments to manage all related conditions. Similarly, transplant patients need close monitoring of the grafted organ and immunosuppressant therapy.” But Manko and colleagues noted that “prior systematic reviews focused on telehealth and eHealth interventions in dialysis patients have shown conflicting results with potential benefits [and] more adequately powered prospective studies are needed.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Fourth time’s the charm? Sanford Health is hoping so.
    • “Less than a year after scrapping its proposed merger with a Minnesota health system— its third failed deal since 2019 — South Dakota’s Sanford is attempting a new, multibillion-dollar mashup. The $7 billion, 45-hospital system plans to absorb Marshfield Clinic Health System, a $3 billion system of 11 hospitals across Wisconsin and northern Michigan.
    • “The proposed deal would make Sanford Marshfield’s parent company, creating a 56-hospital system with Sanford’s name, CEO, and headquarters in Sioux Falls, S.D. The combined system would have about 56,000 employees, 4,300 doctors and advanced practice providers, two health plans with more than 425,000 members, specialty pharmacies, and research institutions. The systems said they plan to close the deal by the end of the year.
    • “Sanford CEO Bill Gassen told STAT in an interview that Sanford and Marshfield are a good fit not only from a regulatory perspective — they have no overlapping coverage areas — but more importantly, from a cultural one. He said both nonprofit systems strive to deliver world-class care in rural areas. They both want strong physician leaders. They both have big health plans. They both do research and train doctors.”
  • Bloomberg relates,
    • “Purdue Pharma LP secured a two-month window to negotiate a new pact with members of the Sackler family as the OyxContin maker and its owners brace for a potential wave of civil opioid lawsuits after the US Supreme Court scuttled an earlier $6 billion settlement.
    • “Judge Sean Lane said during a Tuesday court hearing in New York that he’d extend for 60 days an injunction that, for years, has paused opioid litigation against the billionaire family while Purdue, government authorities and victims lawyers attempted to effectuate the earlier settlement.
    • “Advisers who negotiated the earlier deal will attempt to cut a new agreement during the two-month window that complies with the Supreme Court’s ruling. Such a settlement, if successful, would likely compensate victims and provide billions of dollars to fund programs to combat the nation’s opioid addiction crisis.” 
  • Healthcare Dive lets us know,
  • and
    • offers more insights into the 2024 Medicare Advantage star rating changes that CMS made recently in response to court decision.
  • The New York Times points out that “In Constant Battle With Insurers, Doctors Reach for a Cudgel: A.I. As health plans increasingly rely on technology to deny treatment, physicians are fighting back with chatbots that synthesize research and make the case.”
  • ICD-10 Monitor asks us whether we are ready for the new ICD-10 diagnosis codes that take effect October 1, 2024.
  • Drug Channel peers into its crystal ball to project prescription drug spending in 2032.

Tuesday Tidbits

David Ermer–AHRQ, Congress, Medical / Rx research, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • This morning, the Federal Trade Commission released an interim staff report on its ongoing investigation of prescription benefit managers. The report was favorably received by Senators Wyden and Grassley. Healthcare Dive summarizes the report here.
  • The FEHBlog recalls when around 2009 the State of New York went after UnitedHealthcare for offering a for profit service that provided usual, reasonable and customary rates for out-of-network providers. In a legal settlement, UnitedHealthcare transferred the service to a new not-for-profit company called Fair Health. Meanwhile most health plans had switched to the Medicare Part RBRVS pricing as base for its UCR reimbursements. Nevertheless, Fair Health is still around.
  • Today, the American Hospital Association News tells us,
    • “An op-ed published July 9 in Modern Healthcare written by AHA President and CEO Rick Pollack and Catholic Health Association President and CEO Sr. Mary Haddad discusses why nonprofit hospitals need positive margins. The commentary piece seeks to add important context and education to the conversation around nonprofit hospitals’ community benefit, tax-exempt status and other issues, arguing that positive margins are necessary to maintain basic services and advance care for all patients and communities 24/7. “Barely making ends meet or operating at a financial loss should never be the goal or an acceptable status quo for any nonprofit healthcare organization,” Pollack and Haddad write. “It’s not just bad economics; it also impedes institutions’ ability to deliver services and improve health outcomes.”
  • If the regulators are considering taking a page out of the Fair Health playbook, consider this finding from a USC-Brookings report issued last September:
    • “Pre-tax operating margins for the three largest PBMs averaged a bit more than 4% of their revenues in 2022. Since PBMs’ revenues encompass both the administrative fees charged to PBMs and payers’ net payments for claims, this implies that even completely eliminating PBMs’ margins [a no-no] would only modestly reduce payers’ drug-related costs. Achieving larger reductions would require reducing the revenue captured by pharmacies or, particularly, manufacturers. Ultimately, the amount of revenue that manufacturers capture depends principally on the extent of intellectual property protections related to drugs and whether and how the prices that drug manufacturers receive are regulated.”
  • The healthcare industry is complex, to say the least, and there are no simple answers.

From the public health and medical research front,

  • “Did you know that the U.S. Preventive Services Task Force (Task Force) has a free app called Prevention TaskForce? This app can help healthcare professionals identify which screenings, counseling interventions, and preventive medications are right for their patients. It includes all current Task Force recommendations and can be searched by specific patient characteristics, such as age, sex/gender, and selected behavioral risk factors. Download the app, on mobile or desktop, to find the preventive services that can help keep your patients healthy.”
    • “For more information and to download the app, click here.”
  • STAT News reports,
    • “In a long-awaited study, patients in Australia will soon receive an IV infusion designed to transform their own immune cells into swarms of cancer-fighting drones.
    • “The trial, announced on Tuesday by Interius Biotherapeutics, will be the first to test what’s known technically as in vivo CAR-T therapy. Researchers have long hoped the approach could provide a potentially cheaper, safer, and more scalable version of the cell therapies that are curative for some blood cancer patients but remain out of reach for many. 
    • “Interius received regulatory clearance on June 28 and will dose up to 30 patients, beginning in the fall. It beat out several competitors, including one with over $1 billion in funding, to the first-in-human trial.  
    • “There are absolutely people alive out there today that would not have been without the CAR technology,” said Dora Mitchell, Interius’ senior vice president for operations. But the therapy is still only delivered in some places in the U.S. and Europe and almost nowhere else. “The vision that catalyzed the formation of Interius was: can we bring this to the masses?”
  • Healio informs us,
    • “There is insignificant evidence to support recommendations that children with autism will benefit from intensive interventions, according to the results of a meta-analysis published in JAMA Pediatrics.
    • “One of the study’s authors told Healio that in reviewing standard intervention recommendations for autism in children, she found that one recommended that children receive at least 20 hours or up to 40 hours of intensive intervention per week.
    • “This recommendation originated initially from a quasi-experimental study conducted in the ’80s that, although remarkable for the time, was flawed,” Micheal P. Sandbank, PhD, director of The Brain and Language Lab at the University of Texas at Austin, told Healio. “There have been additional studies since then, but most were quasi-experimental and compared intensive intervention with different uncontrolled supports, failing to isolate the effect of intensity specifically from the effect of providing a systematic and comprehensive intervention approach.”
  • The Washington Post explains what to know about six popular home tests for urinary tract infections, menopause, allergies, colon cancer, A1c blood sugar and thyroid conditions.

From the U.S. healthcare business front,

  • Beckers Hospital CFO report informs us,
    • “Average hospital margins year to date remained steadfast in May at 3.8%, according to Kaufman Hall’s “National Hospital Flash Report,” released July 9.
    • “Hospital financial performance remained relatively unchanged during the month of May, and the rate of change slowed for margins and other key performance indicators, which reflects stabilization,” wrote Erik Swanson, senior vice president at Kaufman Hall.
    • “The stabilization is a positive sign for hospitals after ending the year with average margins at 1.9%. The average hospital margin shot up in January to 4.6% and then decreased slightly in February and March.
    • “From April to May, the monthly average operating margin index dipped from 4.2% to 3.7%. Operating margins increased 23% year to date over the same period last year.”
  • BioPharma Dive reports,
    • “Pfizer’s top scientist Mikael Dolsten is stepping down after leading the drugmaker’s research and development for the past 15 years, a period that includes Pfizer’s remarkable success developing a COVID-19 vaccine but ends with the company at a crossroads.
    • “On Tuesday, Pfizer said it has begun searching for a successor to Dolsten, who in 2010 became chief scientific officer as well as R&D head. The process is expected to last “probably through early next year,” Pfizer said.
    • “Dolsten will help with the search and continue to serve in his current position until a successor is in place and “any necessary transition is complete,” according to Pfizer.”

Friday Factoids

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

From Washington, DC,

  • Federal News Network tells us,
    • “Although the federal workforce on the whole is relatively diverse, much of that diversity is condensed on the lower end of the General Schedule.
    • “It’s a demographic trend that has persisted for years, but there may be a few early signs of change, according to a July 1 workforce report from the Partnership for Public Service that uses data from FedScope.
    • “Data from fiscal 2023 shows that 60% of the federal workforce is white, 19% of federal employees are Black and 10% are Hispanic. By comparison, for the nationwide workforce, 76% of employees are white, 13% are Black and 19% are Hispanic.
    • “Breaking down diversity by GS level, the Partnership’s data report shows that white federal employees make up a much larger portion of the workforce at GS-7 and up through the Senior Executive Service, taking up many mid- and top-level technical roles as well as many supervisory positions.” * * *
    • “The long-time workforce trend is beginning to change, albeit slowly, the Partnership said. Between 2022 and 2023, the percentage of people of color in the SES rose 1%, from 25% to 26%.
    • “Similar trends occur when breaking down the workforce by gender. Overall, women make up 45% of the federal workforce, while men comprise 55%. But again, men make up a larger portion of higher-level GS positions as well as SES roles. There appears to be a similar trend toward a more equal balance between men and women in the SES, the Partnership’s report showed.”
  • STAT News informs us,
    • “A federal judge ruled against Boehringer Ingelheim’s challenge to the new Medicare drug price negotiation program, handing the pharmaceutical industry its latest in a string of legal losses.
    • “The company had argued before the U.S. District Court of Connecticut that the drug pricing law was unconstitutional under four different parts of the Constitution, and also that Medicare officials had violated procedural laws. Judge Michael Shea ruled against Boehringer Ingelheim on each point in a decision published late Wednesday.
    • “Boehringer Ingelheim did not immediately respond to a request for comment on the ruling. The company’s diabetes drug Jardiance was one of the first medicines selected for the negotiation program.
    • “Federal judges have also ruled against drugmakers including AstraZeneca, Bristol Myers Squibb, and Johnson & Johnson, and trade groups including the brand-drug lobby PhRMA and the U.S. Chamber of Commerce in their lawsuits challenging the law.”
  • HR Dive lets us know,
    • “A Texas federal judge on Wednesday granted a tax services firm’s motion for a preliminary injunction of the Federal Trade Commission’s nationwide ban on noncompete agreements in employment contracts and has stayed its effective date for the plaintiffs.
    • “Judge Ada E. Brown of the U.S. District Court for the Northern District of Texas held that FTC violated the Administrative Procedure Act and exceeded its statutory authority by issuing the ban, which she said has a “substantial likelihood” of being found arbitrary and capricious.
    • “Brown said the injunction is limited in scope to the plaintiffs and plaintiff-intervenors named in the suit; it is not a nationwide injunction. She added that the court would rule on the merits of the agency’s action on or before Aug. 30, 2024.”

From the public health and medical research front,

  • The Centers for Disease Control announced today,
    • “Summary
      • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in some areas.
    • “COVID-19
      • “Some areas of the country are experiencing consistent increases in COVID-19 activity, including increases in COVID-19 test positivity and emergency department visits and increases in rates of COVID-19–associated hospitalizations among adults 65+ at several sites. However, nationally COVID-19 activity remains low. Recent increases in activity level are from very low levels in April and May 2024, when they were lower than at any time since March 2020. CDC will continue to closely monitor trends in COVID-19 activity.
    • “Influenza
    • “RSV
      • Nationally, RSV activity remains low.
    • “Vaccination
  • The New York Times adds,
    • “Many of us associate Covid with respiratory issues. But some people who get sick with the virus never experience a sore throat, coughing or body aches, said Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco. Certain people end up feeling more like they have food poisoning than anything else.
    • “That’s because coronavirus is “like throwing a bomb in your body,” said Dr. Ken Cadwell, a professor of medicine at the University of Pennsylvania who studies how Covid affects the gut. “You’re going to feel that in multiple different organs, not just the lungs.”
    • The article offers tips on how to spot Covid symptoms.
  • The Washington Post discusses cancerphobia in an era when cancer deaths have been falling and provides cancer prevention tips.
  • The Food and Drug Administration announced,
    • “On Wednesday, the FDA updated the advisory for the investigation of Salmonella illnesses linked to cucumbers. The FDA and CDC, in collaboration with state and local partners, are investigating a multistate outbreak of Salmonella Africana and Salmonella Braenderup infections with 449 illnesses in 31 states and the District of Columbia.
    • “While originally reported as two separate outbreaks, CDC and FDA combined these two outbreak investigations as they shared several similarities, including when and where illnesses occurred, the demographics of ill people, and the foods they reported eating before they became sick.
    • “Laboratory, epidemiological, and traceback data have determined that cucumbers from Bedner Growers, Inc., of Boynton Beach, Florida, are a likely source of illnesses in this outbreak; however, this grower does not account for all the illnesses in this outbreak. Bedner Growers, Inc.’s cucumber growing and harvesting season is over. There is no product from this farm on the market and likely no ongoing risk to the public.”
  • Per MedPage Today,
    • “GLP-1 receptor agonists lowered the risk of several obesity-associated cancers, a retrospective analysis of electronic health records suggested.
    • “Compared with insulin, GLP-1s were associated with a lower risk for developing 10 of 13 cancers in people with type II diabetes, reported Nathan Berger, MD, of the Case Western Reserve University in Cleveland, and colleagues in JAMA Network Open.
    • “No decrease in cancer risk was associated with GLP-1 receptors compared with metformin.
    • “This study adds to the growing body of evidence supporting the pleiotropic effects of GLP-1 receptor agonists on cancer prevention, including obesity-associated cancers,” co-author and medical student Lindsey Wang, also of Case Western Reserve University School of Medicine, told MedPage Today. (Berger passed away before the study was published.)
  • Per Healio,
    • “Many women aged 75 years and older are aware of the importance of breast cancer screening and desire to continue screening regardless of health status or age, according to a scoping review published in BMC Women’s Health.
    • “Very few studies have been undertaken to understand the motivations of women to screen or to establish screening participation rates among women aged 75 and older,” Virginia Dickson-Swift, PhD, senior research fellow at the Violet Vines Centre for Rural Health Research at La Trobe Rural Health School at La Trobe University, Australia, and colleagues wrote. “This is surprising given that increasing age is recognized as a key risk factor for the development of breast cancer, and that screening is offered in many locations around the world every 2 years up until age 74 years.” * * *
    • “Decision aids may be effective in improving knowledge of the benefits and harms of breast screening as many women reported poor knowledge, according to the authors. A pilot study of eight women in the U.S. utilizing decision aids demonstrated that 62.5% of women planned to continue receiving mammography. In this study, agreeing that their physician would recommend mammography dropped from 80% to 62.5% after exposure to the decision aid. These results suggest that decision aids might result in fewer women continuing breast cancer screening beyond age 75 years.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Pharmaceutical giant AbbVie paid health care providers roughly $145.7 million last year to promote its drugs, according to a STAT analysis of newly released government data.”
    • “The massive sum spent by AbbVie, the maker of the mega blockbuster anti-inflammatory drug Humira, is the most a pharmaceutical company has spent on marketing to doctors since such data became available in 2017. The figure includes compensation for consulting and other services like speaking fees, lodging and travel for doctors, and meals, as well as a small number of payments made directly to hospitals.
    • “The payments, made public by the Centers for Medicare and Medicaid Services, provide an insight into AbbVie’s marketing in the immediate aftermath of the company losing its monopoly on Humira, which dominated the company’s balance sheets for the better part of the last two decades. The payments show that the company is being far more aggressive in targeting doctors than competitors of comparable size.
    • “Pfizer, whose revenues are on par with AbbVie’s, spent roughly $32 million last year. Merck spent about $22 million. These totals don’t include subsidiaries that are reported separately from their parent companies.”
  • Managed Care Executive assures us that notwithstanding this colossal effort, biosimilars to Humira are gaining market share due to PBM actions and legal changes.
  • PCMA points out various PBM efforts to reach out to the rural community.
  • The Wall Street Journal suggests that the Walmart model does not work in healthcare.
    • “To put it bluntly, primary care is hard,” said Stephanie Davis, an analyst at Barclays. The problem for Walmart, said Craig Garthwaite, a strategy professor at Northwestern University, is that in medicine you can’t really build economies of scale by driving the costs of such things as purchasing and advertising down to charge lower prices and gain market share. In a doctor’s office, your big-ticket costs are the people: A family physician might make something like $250,000, while a nurse practitioner is paid around $150,000. 
    • “None of that is scalable,” he said. “Each one of those doctors can only work eight to 10 hours a day. So you can’t run the business the same way.” * * *
    • “That doesn’t mean that there isn’t plenty of money to be made from the doctor’s office. But the value won’t come from charging a flat fee for, say, an annual checkup. Instead, for large companies, the doctor needs to be a conduit for capturing value elsewhere. Big hospital systems have been at this for a long time. They acquire or join with doctor groups to control patient traffic to higher-margin procedures. A primary-care doctor controlled by New Jersey-based Atlantic Health System, for instance, might refer a patient to a urologist within that same system.  
    • “That approach really hasn’t helped patients. Instead, it has raised the cost of care, giving giant hospitals billions of dollars in additional revenue.” 
  • Similarly, mHealth Intelligence examines the limitations of the current telehealth market.