Midweek update

Telehealth

Midweek update

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

From Washington, DC,

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

From the public health and medical research front

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

From the U.S. healthcare business front,

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

    Tuesday Tidbits

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

    From Washington, DC

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

    From the public health and medical research front,

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

    From the U.S. healthcare business front,

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

    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.”

    Thursday Miscellany

    David Ermer–CDC, Congress, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, Telehealth, U.S. Healthcare–
    Photo by Josh Mills on Unsplash

    From Washington, DC,

    • Modern Healthcare reports,
      • “A powerful Senate committee plans to commence a bipartisan investigation into the Steward Health Care meltdown next week.
      • “The Senate, Health, Education, Labor and Pensions Committee will convene next Thursday for a vote to officially kick off a probe into the insolvent Dallas-based health system. Steward Health Care Chair and CEO Dr. Ralph de la Torre will be subpoenaed to testify at a hearing Sept. 12, HELP Committee Chair Bernie Sanders (I-Vt.) and ranking member Dr. Bill Cassidy (R-La.) said in a news release Thursday.
      • “Given the serious harm and uncertainty Steward’s bankruptcy and financial arrangements are having on hospitals, patients and healthcare workers throughout the country, Dr. de la Torre has given us no choice but to compel him to testify at this hearing,” Sanders and Cassidy said.
      • “De la Torre declined to attend a HELP Committee hearing last month and a subcommittee session in April.
      • “We have a number of questions to ask Dr. de la Torre about the bankruptcy of Steward Health Care and the financial arrangements leading up to its insolvency. It is time for Dr. de la Torre to answer them before Congress and the American people,” Sanders and Cassidy said.
    • Federal News Network informs us,
      • “The Office of Personnel Management will soon be reopening enrollments into the government’s Flexible Spending Account program, FSAFEDS.
      • “OPM previously suspended all new enrollments in the program after a recent surge in fraudulent activity that impacted hundreds of federal employees with Flexible Spending Accounts. OPM’s inspector general said the suspension came “out of an abundance of caution,” and to try to prevent further fraud in the program.
      • “Enrollments in FSAFEDS, including any enrollments based on Qualifying Life Events (QLEs), will reopen Aug. 1, OPM wrote in an email to agency benefit officers Thursday afternoon, shared with Federal News Network. Also beginning Aug. 1, the program will transition to a “.gov” website domain, FSAFEDS.gov, rather than the current domain, FSAFEDS.com.
      • “Enrollees who missed a QLE deadline due to the pause on enrollments should still be able to make modifications once the enrollment pause is lifted, OPM said. Employees who are in that situation will have to call FSAFEDS at 877-372-3337 to request a change to the effective date for the QLE.
      • “Additionally, federal employees will be able to get reimbursed for any claims that were incurred after the effective date for the QLE, OPM said.
      • “OPM is also taking more long-term steps to address security concerns in FSAFEDS, including transitioning to Login.gov, the government’s platform for accessing government benefits and services online.”
    • Per Govexec,
      • “The Office of Personnel Management wants federal agencies to let it know how many senior executives, scientific/professionals and other senior-level personnel they estimate they will need for the next two years.
      • “OPM outlined its biennial review of agency executive allocations in a July 10 memorandum, calling on agency and department heads to examine their potential Senior Executive Service needs through fiscal 2026 and 2027 and how they may have changed. 
      • “The biennial review, which is required by statute, will give agencies until Nov. 22 to fully outline their anticipated SES needs, but they must also detail the projections of their position needs in their Senior Level and Scientific/Professional pay systems by Aug. 23. 

    From the public health and medical research front,

    • Beckers Hospital Review tells us,
      • “The highest numbers of breast and cervical cancer deaths are found mostly in southeastern states, according to new data from the “2024 State Scorecard on Women’s Health and Reproductive Care” released July 18 by The Commonwealth Fund.
      • “The analysis is based on 2021-22 data from publicly available sources. Learn more about the methodology here.
      • “Alabama, Arkansas, Delaware, the District of Columbia, Indiana, Kentucky, Louisiana, Mississippi, Missouri, Nevada, Oklahoma, Tennessee and West Virginia had 23.2 to 27.8 breast and cervical cancer deaths per 100,000 female population, the highest numbers in the country.”
    • The NIH Director, in her weekly blog, lets us know,
      • “Alzheimer’s disease is currently the seventh leading cause of death in the U.S. While your likelihood of developing Alzheimer’s-related cognitive impairment increases with age, risk for this disease and age of its onset depend on many factors, including the genes you carry. An intriguing new study suggests that having just one copy of a protective gene variant may be enough to delay cognitive impairment from this devastating disease in individuals who are otherwise genetically predisposed to developing early-onset Alzheimer’s dementia.
      • “The findings, from a study supported in part by NIH and reported in The New England Journal of Medicine, offer important insights into the genetic factors and underlying pathways involved in Alzheimer’s dementia. While much more study is needed, the findings have potential implications for treatments that could one day work like this gene variant does to delay or perhaps even prevent Alzheimer’s dementia.”
    • The Washington Post reports,
      • “If you want to increase your odds of living a long and healthy life, watch less television and become more physically active, because even a small amount of physical activity can improve overall health, according to an observational study published last month in JAMA Network Open.
      • “While there have been many studies showing that moderate to vigorous physical activity is associated with healthy aging, researchers wanted to know if light physical activity compared with sedentary behaviors also improves healthy aging, and if not, how can people’s time be reallocated.
      • “They found that replacing a sedentary behavior such as watching TV with even low-intensity activity — such as standing or walking around while cooking or washing clothes — increased one’s odds of healthy aging. And at work, replacing some of the time spent sitting with simple movements such as standing or walking around the office can improve health.
      • “These findings indicate that physical activity need not be high intensity to potentially benefit various aspects of health, which have especially important public health implications as older people tend to have limited physical ability to engage in moderate-to-vigorous physical activity,” Molin Wang, an associate professor in epidemiology at the Harvard T.H. Chan School of Public Health and an author of the study, wrote in an email.”
    • Per Medscape,
      • “An analysis based on a massive database of US electronic health records (EHRs) adds to evidence favoring the safety of glucagon-like peptide 1 (GLP-1) medications, finding no increased risk for many neurologic and psychiatric ailments when semaglutide was compared with other diabetes drugs.
      • “Riccardo De Giorgi, MD, DPhil, of the University of Oxford, Oxford, England, and colleagues published their research in eClinicalMedicine.”
    • Bloomberg informs us,
      • “Opioids. They’re a public-health pariah, leading to more than 80,000 overdose deaths a year. Patients worry they’ll get addicted to them. Doctors want nothing to do with them. And politicians of all stripes are calling for less dangerous options for treating pain.
      • “We are looking for absolutely anything that’s not an opioid,” says Seth Waldman, an anesthesiologist and director of pain management at Hospital for Special Surgery, a top orthopedic medicine center.
      • “Against that backdrop, the success of a safer painkiller would seem assured. A new drug, which Vertex Pharmaceuticals Inc. is developing, has been hailed as a scientific breakthrough because it treats pain without entering the brain, where opioids create addicts. The drug, suzetrigine, met its goal this year in pivotal trials for acute pain and is poised to become the first new class of pain medication in more than two decades.
      • “But all that may not be enough to loosen the grip opioids have on American medicine. Despite their dismal reputation, they have two powerful things going for them: They’re cheap, and they work. The number of opioid prescriptions has been cut by half over the past decade, but some 130 million are still doled out each year.” * * *
      • “Vertex is betting the nonaddictive properties of its drug will make it an attractive alternative to opioids. But it isn’t leaving anything to chance. Knowing it faces an uphill battle commercially, the company last year boosted its lobbying spending almost 50%, to more than $3 million. Vertex is pressing Congress for new policies that remove “structural impediments” blocking access to opioid alternatives, says Stuart Arbuckle, its chief operating officer.
      • “Vertex has scored at least one legislative victory: The No Pain Act, which goes into effect next year, provides an extra Medicare reimbursement to hospitals that prescribe alternatives to opioids. Another bill introduced this year in Congress would prohibit step therapy and limit how much Medicare patients pay out of pocket for non-opioids.
      • “Other types of new drugs face this cost hurdle, too. The rollout of new contraceptives or antibiotics has been hampered by insurers guiding doctors and patients to older, less pricey meds. The difference is that those generics haven’t been declared a public-health emergency.”
    • Mercer Consulting points out “four things employers need to know about summer heat.”
    • The New York Times reports,
      • “A daily dose of a widely used antibiotic [doxycycline] can prevent some infections with syphilis, gonorrhea and chlamydia, potentially a new solution to the escalating crisis of sexually transmitted infections, scientists reported on Thursday.
      • “Their study was small and must be confirmed by more research. Scientists still have to resolve significant questions, including whether S.T.I.s might become resistant to the antibiotic and what effect it could have on healthy gut bacteria in people taking it every day.
      • “The approach would be recommended primarily to people at elevated risk of sexually transmitted infections during certain periods, said Dr. Jeffrey Klausner, an infectious diseases physician at the University of Southern California who was not involved in the new work.
      • “The number of people who are really going to be offered this and take this is still very small,” he said. “In general, the more choices we have for people, the more prevention options we have, the better.”

    From the U.S. healthcare business front,

    • Per Fierce Pharma,
      • “GoodRx is joining forces with drugmaker Boehringer Ingelheim to make its Humira biosimilar adalimumab available at an affordable price.
      • “The pharmaceutical company will offer citrate-free adalimumab-admb at a cash price available only on GoodRx, according to an announcement. This will allow anyone with a prescription to obtain the drug at one of 70,000 pharmacies nationwide, even if they’re uninsured.
      • “Beginning on July 18, Boehringer and GoodRx will offer high-concentration and low-concentration formulas of the drug in auto-injectors or pre-filled syringes at a price of $550 per two pack. The companies said that this is a 92% discount compared to a Humira prescription.”
    • Per Beckers Hospital Review,
      • “The FDA is allowing Mark Cuban Cost Plus Drug Co. to temporarily import a syphilis drug that has been in shortage for more than a year. 
      • “Penicillin G benzathine injection fell into low supply in April 2023, and since then, clinicians have been rationing the product. In January, the FDA issued a temporary authorization for French drugmaker Laboratoires Delbert to import penicillin G benzathine. 
      • “On July 17, the FDA updated its post on the drug’s shortage. To address the scarcity, the agency cleared Cost Plus Drugs to import the medication from Laboratórios Atral.
      • “The Portugal-based drug company will export two presentations of Lentocilin (benzathine benzylpenicillin tetrahydrate), according to FDA documents.
      • “Cost Plus Drugs is selling this medication to healthcare businesses for less than $15, the company said in July 17 post on X.” 
    • Segal Consulting relates,
      • “The average stop-loss coverage premium increase is 9.4 percent for the nearly 240 health plans in Segal’s 2024 national medical stop-loss dataset.”
      • “The average includes groups that increased specific stop-loss deductible levels and/or aggregating specific stop-loss deductibles resulting in an overall reduced rate action. The average premium increase for groups that maintained similar specific stop-loss benefit levels as the prior year is 11.5 percent.”
    • Per Fierce Healthcare,
      • “Telehealth giant Teladoc is partnering with startup Brightline to extend virtual mental healthcare services for children, adolescents and their families.
      • “Through the partnership, members under the age of 18 will have access to Brightline’s behavioral health solutions through Teladoc’s virtual “front door,” the companies said.
      • “The collaboration with Brightline builds on Teladoc’s existing mental health offerings and expands access to care to members of all ages, a Teladoc spokesperson said.”
    • Beckers Hospital Review identifies seven U.S. hospitals that have received brain tumor care certification by the Joint Commission.
      • Chippenham and Johnston-Willis Hospital, Richmond, VA
      • Hackensack (N.J.) University Medical Center Hackensack
      • Jewish Hospital, Cincinnati, OH
      • Pitt County Memorial Hospital, Greenville, N.C.
      • Santa Barbara (Calif.) Cottage Hospital
      • St. Vincent Hospital and Health Care Services, Indianapolis, IN
      • Texas Health Harris Methodist Hospital – Fort Worth, TX
    • Healthcare Dive lets us know,
      • “Humana has made a minority investment in Healthpilot, a company that aims to help beneficiaries choose Medicare plans, the insurer said Wednesday. Financial terms of the deal weren’t disclosed.
      • “Healthpilot uses an artificial intelligence model to recommend Medicare Advantage, Medicare supplement and prescription drug plans based on enrollee information.
      • “Healthpilot will continue to recommend plans options from other payers following the investment, Humana said in the release. 

    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.” 

    Thursday Miscellany

    David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, NIH, Obesity, SDOH, Telehealth–

    From Washington, DC,

    • Govexec informs us,
      • “The Senate on Thursday made progress on advancing bipartisan spending bills for fiscal 2025, though members of both parties acknowledged significant divisions remain between the two sides. 
      • “The chamber’s Appropriations Committee approved three of the 12 annual funding measures Congress must pass each year—those funding the departments of Agriculture and Veterans Affairs, as well as the legislative branch—in unanimous, 27-0 votes. While that marked a significant step forward in the fiscal 2025 process and an accomplishment that has eluded the panel’s House counterpart—which has advanced its bills to date only along partisan lines—the Senate could not come to a bipartisan agreement on how much money to allocate for the remaining nine funding measures.”
    • and
      • “The Senate on Wednesday voted 55-37 to confirm Anne Wagner as the third member of the Federal Labor Relations Authority, finally bringing the agency’s political leadership to nearly full strength.
      • “Similar to the National Labor Relations Board’s role overseeing collective bargaining in the private sector, the FLRA governs labor-management relations at federal agencies, with a three-member board that settles unfair labor practice complaints and other disputes between unions and management.” * * *
      • “Federal employee unions rejoiced at the news that the FLRA’s board was now fully staffed. The last 18 months of deadlock between [Colleen Duffy] Kiko and FLRA Chairwoman Susan Tsui Grundmann has meant the board could only rule in noncontroversial cases.”
    • The American Hospital Association News lets us know,
      • “The Senate Committee on Health, Education, Labor and Pensions held a hearing July 11 on medical debt. The AHA submitted a statement for the hearing that highlighted how the quality of insurance coverage is a driver of medical debt, saying that coverage for many patients is either insufficient or unavailable. The AHA discussed hospital and health system efforts offering financial and other assistance, and that hospitals absorb billions of dollars in losses for patients who cannot pay their bills, mainly due to inadequate commercial insurance coverage. To address the issue, the AHA urged Congress to restrict the sale of high-deductible health plans to individuals with the ability to afford the associated cost-sharing; prohibit the sale of health-sharing ministry products and short-term limited-duration plans that go longer than 90 days; and lower the maximum out-of-pocket cost-sharing limits, among other changes.”
      • That’s nuts, and it’s worth adding that all of the witnesses, except for one, were from the creditor side. Here’s a link to the American Enterprise Institute testimony.
    • The AHA News adds,
      • “The Centers for Medicare & Medicaid Services July 10 announced there will be 133 participants representing 772 practices for its new Making Care Primary Model. Participants in this voluntary model are from Colorado, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Carolina and Washington. The model, which began July 1 and will run through 2034, seeks to improve care management and care coordination, enable primary care clinicians to partner with health care specialists, and use community-based connections to address patients’ health needs as well as their health-related social needs such as housing and nutrition.”
    • and
      • “The Centers for Medicare & Medicaid Services recently released results of an air ambulance qualifying payment amount calculations audit on Aetna Health in Texas. The report found that Aetna used practices that did not comply with federal requirements, and strongly recommended corrective actions. Specifically, the report found that Aetna failed to “properly calculate the QPA by using claim paid amounts instead of contracted rates, and counting each claim as its own contracted rate, even when the claims were for the same amounts for the same item or service and to the same provider of air ambulance services.” Aetna may also be subjected to future audits.”

    From the public health and medical research front,

    • The Washington Post reports,
      • “Research into chronic conditions affecting women is significantly lacking, and the National Institutes of Health and other agencies should do more to investigate issues that lead to worse medical treatment for women, a new report from the National Academies of Sciences, Engineering and Medicine says.
      • “Women are disproportionately affected by chronic illnesses, including Alzheimer’s disease and depression, according to the study requested by NIH’s Office of Research on Women’s Health and published Wednesday.
      • “But inadequate research in women’s health “hinders a comprehensive understanding of the impact on women” of these and other chronic illnesses, the report’s authors write. Further research is needed, particularly for Black women, who are more likely to die of a chronic illness than White women, the study says.”
    • and
      • “Nearly 1 in 10 people infected with the coronavirus during pregnancy developed long covid, according to a study published Thursday in the journal Obstetrics and Gynecology.
      • “Thursday’s study, which highlights the consequences of the virus during pregnancy, suggests long covid is more prevalent among people infected while pregnant than in the population overall. As many as 7 percent of Americans report having symptoms associated with long covid, according to a 2022 report from the Centers for Disease Control and Prevention. Some surveys suggest a far higher incidence of long covid in the general population.” * * *
      • “I was initially surprised at the prevalence of long covid in this population,” said Torri Metz, one of the study’s lead authors and a maternal-fetal medicine specialist at University of Utah Health. “It really drew my attention to the fact I need to have this on my radar when I am seeing patients.”
    • NBC News informs us,
      • “A key mystery behind one of the most common autoimmune diseases may finally have an answer.
      • “Researchers at Northwestern Medicine and Brigham and Women’s Hospital say they’ve discovered a root cause of lupus, a disease that affects hundreds of thousands of people in the U.S. 
      • “Scientists have long suspected that a person’s genetics or hormones may predispose them to lupus, and that the disease may be triggered by environmental factors like a previous viral infection or exposure to certain chemicals.
      • “Now, a study published Wednesday in the journal Nature outlines a clear pathway for how the disease likely develops, pointing to abnormalities in the immune systems of people with lupus.”
    • Neurology Advisor points out,
      • “The prevalence of stroke has increased by 14.6% from 2011 to 2022 among individuals aged 18 to 44 and 15.7% among those aged 65 and younger in the United States, according to a report published in Morbidity and Mortality Weekly Report.
      • “Researchers assessed trends in stroke prevalence between 2011 and 2022, using data from the Behavioral Risk Factor Surveillance System (BRFSS), a state-based surveillance system administered to noninstitutionalized civilian adults in the US in collaboration with the Centers for Disease Control and Prevention (CDC). * * *
      • “Age-standardized prevalence of stroke increased from 2.7% in 2011 to 2013 to 2.9% in 2020 to 2022, marking a 7.8% (95% CI, 4.9%-10.8%) increase in overall stroke prevalence. The researchers noted the highest stroke prevalence (7.7%; 95% CI, 7.5%-7.9%) among individuals aged 65 and older and the lowest prevalence (0.9%; 95% CI, 0.8%-1.0%) among individuals aged between 18 and 44 years.
      • “Stroke was observed to be highest (5.3%; 95% CI, 4.7%-5.9%) among the American Indian or Alaska Native group and lowest among the Asian group (1.6%; 95% CI, 1.2%-2.0%).
      • “With regard to educational level, individuals with a high-school diploma had the highest stroke prevalence (5.2%; 95% CI, 4.8%-5.4%) and those with a college degree or higher had the lowest stroke prevalence (1.7; 95% CI, 1.6%-1.8%).”
    • STAT News relates,
      • “Researchers from the American Cancer Society and International Agency for Research on Cancer estimate 40% of all cancer cases in the United States in people 30 and up were due to “potentially modifiable risk factors,” including cigarette smoking, physical inactivity, consumption of processed meat, viruses, excess body weight, alcohol drinking and more. Data was from 2019 in order to avoid the influence of the pandemic, when cancer diagnoses declined because of delayed care. The results were published in the American Cancer Society’s journal, CA: A Cancer Journal for Clinicians.” * * *
      • “In the study, alcohol was associated with seven cancers: oral cavity, pharynx, larynx, colorectum, and female breast, as well as squamous cell carcinoma in the esophagus, and hepatocellular carcinoma in the liver. Beyond those, “there is accumulating evidence” that alcohol can cause other cancers, such as pancreatic cancer, said lead author Farhad Islami, senior scientific director of cancer disparity research at ACS (which funded the study). 
      • “The increased risk is because of the alcohol in alcoholic beverages, not the type of beverage,” he said. A standard alcoholic beverage in the United States has about 14 grams of pure ethanol. That looks like one 12-ounce serving of 5% ABV beer, a 5-ounce serving of 12% ABV wine, 8-10 ounces of 7% ABV hard seltzer, or 1.5 ounces of 40% ABV liquor. Research suggests the higher a person’s consumption, the higher the risk of cancer.”
    • Here is a link to the NIH Director’s blog titled this week “Sequencing Technique Detects Earliest Signs of Genetic Mutations Underlying Cancer, Aging, and More”
    • The National Institutes of Health announced,
      • “Early findings from a small clinical trial provide evidence that a new cellular immunotherapy approach may be effective in treating metastatic solid tumors. In the trial, researchers from the National Institutes of Health (NIH) genetically engineered normal white blood cells, known as lymphocytes, from each patient to produce receptors that recognize and attack their specific cancer cells. These initial findings are from people with metastatic colorectal cancer who had already undergone multiple earlier treatments. The personalized immunotherapy shrank tumors in some patients and was able to keep the tumors from regrowing for up to seven months. The findings were published July 11, 2024, in Nature Medicine.” * * *
      • “Colon cancer is just one of many solid tumors the researchers are studying. The trial is still ongoing and includes patients with different types of solid cancers.
      • “It’s just the very beginning of converting normal lymphocytes into cells capable of treating the common solid cancers,” Dr. Steven A. Rosenberg, a co-leader of the study, said. “What this study shows is that it’s possible. Once you know it’s possible, you work to improve it.”
    • Here is a link to the All of Us Program’s latest Medical Minutes.

    From the U.S. healthcare business front,

    • Beckers Hospital Review tells us,
      • “As more older adults opt for Medicare Advantage plans, reimbursement fights between hospitals and insurers are increasingly centered around those contracts.
      • “According to data shared with Becker’s by FTI Consulting, there were 20 reimbursement disputes between hospitals and insurers that made headlines somewhere in the country during the second quarter, the same amount as the first quarter and slightly lower than the same period in 2023, when 24 contract disputes were reported in national or local media.
      • “Notably, a record number of Q2 disputes (15 of 20) involved Medicare Advantage plans, and 30% of disputes failed to reach a timely agreement, meaning tens of thousands of patients were left without in-network coverage. FTI has tracked media reports regarding negotiations over reimbursement rates during each quarter since early 2022.”
    • BioPharma Dive reports,
      • “On Thursday, the pharmaceutical giant [Pfizer] said it is advancing a once-daily version of an experimental and closely watched medicine called danuglipron. Pfizer based the decision on results from a small clinical trial of healthy volunteers that’s been evaluating how the body interacts with danuglipron. Studies designed to find the optimal dose of the medicine are scheduled for later this year.
      • “Umer Raffat, an analyst at the investment firm Evercore ISI, speculates that with its update Thursday, Pfizer is “likely buying time” to see more data from a backup once-daily drug it’s been developing. “Candidly, the trial that just wrapped up never answered the question on” what dose would be effective enough to compete, he wrote in a note to clients.
      • “In that backdrop, the judicious thing to do from [the] Pfizer perspective was to not overcommit — and that’s exactly what they did today,” Raffat added. They “didn’t kill [danuglipron], they said it may move forward, but not right to [Phase 3].”
    • Beckers Payer Issues adds,
      • “As insurers continue to face major financial pressures related to covering weight loss drugs, many are steering more patients toward bariatric surgery to achieve similar results.
      • “Insurance companies are seeing that they’re getting more reliable outcomes and savings in the long run if they pay for someone to have bariatric surgery,” Christine Ren Fielding, MD, told Becker’s. Dr. Ren Fielding is a professor of surgery at NYU School of Medicine, the director of the NYU Langone Weight Management Program and chief of the system’s division of bariatric surgery.
      • “If you’re a responder to appetite control caused by a GLP-1, then there’s another treatment option that will do exactly the same thing: bariatric surgery. That includes Lap-Band, sleeve gastrectomy, and gastric bypass,” she said. “Bariatric surgery is the old-fashioned way. Insurers are now putting up barriers for people who want to be covered for GLP-1s and taking down barriers for people who want to have surgery.”
    • STAT News informs us,
      • “The Food and Drug Administration rejected Novo Nordisk’s weekly insulin for the treatment of diabetes in a rare setback for the pharmaceutical giant.
      • “The agency has requests related to the manufacturing process and the use of the insulin specifically in type 1 diabetes patients, Novo said in a statement Wednesday. The company, which had submitted an application for the drug for both type 1 and type 2 patients, said it does not expect to be able to fulfill the requests this year.”

    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.

    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.

    Monday Roundup

    David Ermer–CMS, COVID-19 vaccine, Medical / Rx research, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare, Uncategorized–
    Photo by Sven Read on Unsplash

    Happy Bobby Bonilla Day!

    “The calendar has turned to July 1, and that means one thing: It’s time for Mets fans everywhere to wish each other a Happy Bobby Bonilla Day! Why? On Monday, 61-year-old Bobby Bonilla will collect a check for $1,193,248.20 from the New York Mets, as he has and will every July 1 from 2011 through 2035.”

    The FEHBlog is not a Mets fan. It’s a fun story.

    From Washington, DC,

    • The American Hospital Association News reports,
      • “Changes to the Centers for Medicare & Medicaid Services’ Hospital Price Transparency Rule took effect July 1. Going forward, hospitals are required to use a standard machine-readable file format, which includes some new data elements, such as the negotiated rate methodology and an accuracy and completeness statement.”  
    • Per an HHS press release,
      • “Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), announced more than $200 million to support 42 programs across the country aimed at improving care for older Americans, including those experiencing Alzheimer’s disease and related dementias.”
      • “HRSA’s Geriatrics Workforce Enhancement Program will train primary care physicians, nurse practitioners, and other health care clinicians to provide age-friendly and dementia-friendly care for older adults.  The program also focuses on providing families and other caregivers of older adults with the knowledge and skills to help them best support their loved ones.” * * *
      • “For a full list of award recipients, visit: https://bhw.hrsa.gov/funding/apply-grant/gwep-awardees.”
    • The Washington Post lets us know,
      • “The Federal Trade Commission has opened an investigation into Teva Pharmaceuticals, citing the company’s refusal to take down about two dozen patents for its asthma and COPD inhalers, according to confidential agency documents reviewed by The Washington Post.
      • “The FTC last week sent a civil investigative demand — effectively a subpoena — ordering Teva to provide internal communications, analysis and financial data related to the contested patents listed in a federal registry known as the Orange Book. The agency has argued that pharmaceutical companies such as Teva have wrongly made minor tweaks to their products to keep patents in the Orange Book and fend off generic competition. Teva charges hundreds of dollars for inhalers in the United States that the company sells for a fraction of the price overseas.
      • “Teva has until July 24 to cooperate with the FTC’s demand.”
    • The New York Times reports,
      • “The Supreme Court on Monday gave companies more time to challenge many regulations [under the Administrative Procedure Act], ruling that a six-year statute of limitations for filing lawsuits begins when a regulation first affects a company rather than when it is first issued.
      • “The ruling in the case — the latest in a series of challenges to administrative power this term — could amplify the effect of the blockbuster decision last week overturning a foundational legal precedent known as Chevron deference, which required federal courts to defer to agencies’ reasonable interpretations of ambiguous statutes. That decision imperils countless regulations, particularly on the environment, and advances a longstanding goal of the conservative legal movement.
      • “The vote was 6 to 3, split along ideological lines. Justice Amy Coney Barrett, writing for the conservative majority, rejected the government’s argument that the time limit to sue begins when an agency issues a rule.
      • FEHBlog note — The Supreme Court has completed its October 2023 term.

    From the public health and medical research front,

    • Per an NIH press release,
      • “A Phase 1 trial testing the safety of an experimental nasal vaccine that may provide enhanced breadth of protection against emerging variants of SARS-CoV-2, the virus that causes COVID-19, is now enrolling healthy adults at three sites in the United States. The National Institutes of Health (NIH) is sponsoring the first-in-human trial of the investigational vaccine, which was designed and tested in pre-clinical studies by scientists from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) Laboratory of Infectious Diseases.” * * *
      • “The study aims to enroll 60 adult participants, ages 18 to 64 years old, who previously received at least three prior doses of an FDA-approved or -authorized mRNA COVID-19 vaccine. The trial sites are Baylor College of Medicine, Houston; The Hope Clinic of Emory University, Decatur, Georgia; and New York University, Long Island. Hana M. El Sahly, M.D., at the Baylor College of Medicine Vaccine Research Center, is leading the study.” * * *
      • “More information about the trial is available at clinicaltrials.gov using the identifier NCT06441968.”
    • MedPage Today informs us,
      • “Getting an mRNA COVID-19 shot during the first trimester of pregnancy didn’t lead to an increased risk of major structural birth defects, a multisite retrospective cohort study found.
      • “Major structural birth defects occurred in 1.48% of infants after a first-trimester vaccination and in 1.41% of those without a first-trimester vaccination (adjusted prevalence ratio 1.02, 95% CI 0.78-1.33), Elyse Kharbanda, MD, MPH, of the HealthPartners Institute in Bloomington, Minnesota, and colleagues reported in JAMA Pediatrics.”
      • “Additionally, secondary analyses revealed that there were no significant differences between groups when birth defects were grouped by organ system.
      • “These findings should provide reassurance to pregnant people and their obstetric care practitioners,” the authors concluded.”
    • The Washington Post relates,
      • “People with leg amputations were able to control their prosthetic limbs with their brains in a significant scientific advance that allows for a smoother gait and enhanced ability to navigate obstacles, according to a study published Monday in the journal Nature Medicine.
      • “By creating a connection between a person’s nervous system and their prosthetic leg, researchers at the K. Lisa Yang Center for Bionics at MIT and Brigham and Women’s Hospital paved the way for the next generation of prostheses.
      • “We were able to show the first full neural control of bionic walking,” said Hyungeun Song, first author of the study and a postdoctoral researcher at MIT.”
    • Beckers Hospital Review points out,
      • “The national supply of the cancer drug cisplatin now exceeds demand, FDA Commissioner Robert Cailiff, MD, said June 28. 
      • “The drug, which treats multiple cancers, had been in shortage since February 2023. The shortage occurred after the FDA halted imports from Intas Pharmaceuticals’ manufacturing plant in India in late 2022 due to quality issues. In May 2023, 70% of cancer centers lacked sufficient cisplatin supply, according to a report from the National Comprehensive Cancer Network. 
      • “Low supplies of cisplatin and other cancer drugs have complicated treatments for many patients, with some U.S. cancer centers still struggling to maintain adequate supplies.” 
    • The Washington Post and Consumer Reports identify cures for constipation.
    • BioPharma Dive calls attention to ten clinical trials to watch in the second half of 2024.

    From the U.S. healthcare business front,

    • Mercer explains why healthcare cost – and volatility – has CFOs worried. 
      • “As we head towards the third quarter of 2024, top concerns around health programs are affordability for both employees and employers, the potential impact of GLP-1s on cost trends, and the increased volatility in claims. For fully insured sponsors, claims volatility makes it difficult to predict cost from year to year, while self-insured sponsors may also experience the effects of claims volatility within a given year. Healthcare trends have been impacted by broader economic inflationary pressures with a lag, and the environment will remain challenging for some time to come. While we expect medical cost trends to be similar to last year’s, we see growing cost pressure from prescription drugs, which account for approximately one-third of total health plan costs.”
      • The article compiles Mercer’s findings from a survey of eighty CFOs.  
    • Beckers Hospital Review notes,
      • “If current trends continue, Michael Murphy, PharmD, said all payers will come to recognize pharmacists as healthcare providers by the end of the decade. 
      • “Dr. Murphy, the American Pharmacists Association’s adviser for state government affairs, said there has been “an explosion” of health plans increasing coverage for pharmacists’ services. In a June 26 blog post, he said momentum is building among commercial plans and state Medicaid fee-for-service and managed care plans. 
      • “Pharmacists are being enrolled as providers in much the same way that health plans enroll physicians, nurse practitioners and physician assistants,” Dr. Murphy said. “Pharmacists are also billing for their services in similar ways as other providers. Often, pharmacists submit the same billing codes that other healthcare providers submit for a comparable visit.”
    • STAT News reports,
      • “For 15 years, a formidable CEO-CFO duo often called “the two Tonys” ushered their St. Louis-based health system through a period of explosive growth, adding hospital after hospital until it became one of the country’s biggest health systems.
      • “The year after former CEO Anthony Tersigni and former finance chief Anthony Speranzo stepped down, their sprawling empire of roughly 140 hospitals underwent the ultimate stress test: the Covid-19 pandemic. Ascension has lost almost $4 billion on operations from fiscal 2020 through fiscal 2023, triggering deals to offload almost 30 hospitals. Just last week, Ascension said it would sell its remaining five hospitals in Alabama.
      • “They are going hard on the expense side,” said Stephen Infranco, managing director and head of the nonprofit health care team at S&P Global. “It’s a wait and see approach to how successful it is.”
      • “In a statement, Ascension spokesperson Sean Fitzpatrick said reviewing the hospital portfolio is an ongoing exercise at Ascension. “We are constantly looking for opportunities to prudently prune and grow our care delivery system in an effort to best serve patients in our communities,” he said.”
    • Per Fierce Healthcare,
      • “Amedisys, a large home health provider, plans to divest a number of care centers to an affiliate of VitalCaring Group in advance of its planned merger with UnitedHealth Group later this year.
      • “VitalCaring also acquired some UnitedHealth Group care centers in the deal, according to a filing with the U.S. Securities and Exchange Commission on Friday.
      • “The completion of the divestiture hinges on the closing of the merger between Amedisys and UnitedHealth Group, which is expected to close in the second half of 2024, Amedisys said in the SEC filing.” * * *
      • “This news is unsurprising and relatively on schedule,” wrote Matt Larew, a healthcare research analyst and partner at William Blair in an analyst note. “In May, a report originally surfaced that UnitedHealth and Amedisys were working with regulators on a divestment package of over 100 locations and a short time after it was reported that VitalCaring had emerged as the buyer.”
    • Per Healthcare Dive,
      • “Health technology startup Fabric is acquiring Walmart’s telehealth assets as the retailer exits its healthcare delivery business. 
      • “Fabric, which offers patient intake, care navigation and telehealth services, said Friday it purchased Walmart’s MeMD for an undisclosed amount. MeMD, which Walmart acquired in 2021, provides virtual behavioral, urgent and primary care benefits for 30,000 corporate partners and five million members.
      • “Walmart said in April it would close its healthcare business, citing a challenging reimbursement environment and growing operational costs that limited profitability.”
    • and
      • “Amazon is folding its telehealth marketplace into primary care chain One Medical, unifying its healthcare delivery services under a single brand — and placing One Medical in front of the eyes of engaged telehealth customers, potentially creating a new source of subscriptions.
      • “Amazon is rebranding the marketplace, previously called Amazon Clinic, to Amazon One Medical Pay-Per-Visit. The service, which automatically connects patients to a provider via virtual video or messaging for a flat fee, is also getting more affordable.
      • “Messaging visits are $29, down from around $35, and video visits are $49, down from $75.”

    Friday Factoids

    David Ermer–AHRQ, CDC, Congress, Employee Wellness Programs, Medical / Rx research, Telehealth, U.S. Healthcare–
    Photo by Sincerely Media on Unsplash

    From Washington, DC,

    • STAT News reports,
      • “A House panel is exploring holding a vote on scaled-back versions of two major health care bills that would expand Medicare’s coverage of cancer screening tests and hugely popular weight loss drugs, five sources familiar with the planning told STAT. * * *
      • The two pieces of legislation are the Treat and Reduce Obesity Act, which would allow Medicare to cover obesity drugs and enable more health care providers to provide intensive behavioral therapy for obesity to Medicare patients, and the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, which would allow Medicare to cover multi-cancer blood tests to screen healthy people for cancer. * * *
      • “Full Medicare coverage for both items has broad bipartisan support, but the expansion has been hampered by the likely exorbitant price tags to the federal government. If the House Ways and Means Committee is able to scale back the measures to a more palatable price point, it could increase their chance of passage.
      • “It is unclear how the bills could be limited to decrease their cost, and whether such pared-down proposals could achieve the bipartisan support that would be necessary to make the bills candidates for inclusion in a health care package that’s expected at the end of the year.”
    • BioPharma Dive informs us,
      • “Peter Marks is again at the center of a controversial Food and Drug Administration decision on a gene therapy for Duchenne muscular dystrophy. Twice now, the high-ranking FDA leader has pushed aside objections from agency reviewers to grant an approval to Sarepta Therapeutics’ treatment for the muscle-wasting condition.
      • “On Thursday, the FDA substantially broadened use of that treatment, called Elevidys. The decision makes Elevidys available to approximately 80% of people in the U.S. with Duchenne, which has limited treatment options and no cure. The agency also converted Elevidys’ accelerated approval to full, securing its place on the market. Previously, Elevidys was only approved for a specific group of boys 4 or 5 years of age.
      • “[D]ocuments published by the FDA expose a rift within the agency over Elevidys. Three FDA review teams and two top officials recommended Sarepta’s application be rejected due to insufficient and conflicting clinical data. They were overruled by Marks, head of the FDA center that reviews gene therapies, who found the results supportive enough to broaden Elevidys’ label. It’s now cleared for Duchenne patients over the age of 4 with mutations to a specific gene, regardless of whether they can still walk.
      • “I come to a different conclusion regarding the overall interpretation of the data,” Marks wrote in a memo. * * *
      • “The lasting impact of the approval will likely shape the FDA and gene therapy space for some time,” wrote Tim Lugo, an analyst at the investment bank William Blair, in an investor note Thursday. “We believe a more patient focused and less adversarial FDA review process is likely to continue across several areas in the agency, especially for heterogenous and deadly diseases with few good treatment options.”
    • This morning, the 5th Circuit issued in its opinion in a case challenging the authority of the U.S. Preventive Services Task Force (USPSTF) to make binding preventive services recommendations under the Affordable Care Act. The Court agreed with the lower court that USPSTF members are principal officers of the U.S. due to the binding nature of their recommendations. (HHS argued unsuccessfully that they were inferior officers.). Under the Constitution, the President must appoint principal officers with the advice and consent of the Senate. 
    • The Court granted relief to the individual plaintiffs but rejected the district court’s grant of universal injunction against enforcement of USPSTF recommendations since ACA enactment. The Court remanded the case to the district court for further proceedings.
    • The political ball is in the Biden Administration’s court.

    From the public health and medical research front,

    • The Centers for Disease Control tells us,
      • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in some areas.
      • “COVID-19
        • “COVID-19 test positivity has increased to 6.6% from 5.4% in the previous week. Emergency department visits for COVID-19 are also increasing nationally. Wastewater viral activity is showing increases in some states. We also estimate that COVID-19 infections are growing or likely growing in 39 states and territories, declining or likely declining in 0 states or territories, and are stable or uncertain in 10 states and territories, based on CDC modeled estimates of epidemic growth. KP.3 and LB.1 are projected to continue increasing as proportions of the variants that cause COVID-19 (CDC COVID Data Tracker: Variant Proportions).
      • “Influenza
      • “RSV
        • “Nationally, RSV activity remains low.
      • “Vaccination
    • Health Day lets us know,
      • “A medication used to manage type 2 diabetes has been found effective in treating sleep apnea.
      • “The worldwide clinical trial demonstrates that tirzepatide significantly lowers breathing interruptions during sleep, a key indicator of the severity of a patient’s obstructive sleep apnea (OSA).
      • “Tirzepatide is one of the class of blockbuster GLP-1 medicines, sold as Mounjaro to fight diabetes and as Zepbound to help with weight loss.
      • “This study marks a significant milestone in the treatment of OSA, offering a promising new therapeutic option that addresses both respiratory and metabolic complications,” said study leader Dr. Atul Malhotra, director of sleep medicine at UC San Diego Health. * * *
      • “The findings, published June 21 in the New England Journal of Medicine, add to evidence that a drug targeting both apnea and obesity is better than treating either condition on its own. Researchers said the drug therapy improved other aspects related to OSA, such as improving weight. Some patients, however, had mild stomach issues.”
    • Medscape notes, “Individuals on an intermittent-fasting and protein-pacing (IF-P) diet had fewer gastrointestinal symptoms and increased diversity in gut microbiota than those on a calorie-restricted (CR) Mediterranean-style diet in a small, randomized trial.”
    • The Assistant Secretary of Labor for Employee Benefit Security writes in her blog that “For Men, Taking Care of Your Family Means Taking Care of Yourself.”

    From the U.S. healthcare business front,

    • Beckers Hospital Review reports,
      • “Risant Health, a nonprofit formed under Oakland, Calif.-based Kaiser Permanente, has signed a definitive agreement to acquire Greensboro, N.C.-based Cone Health.
      • “The news comes less than three months after Risant acquired its first health system, Danville, Pa.-based Geisinger Health. 
      • “If the transaction closes, Cone Health will operate independently as a regional and community-based health system under Risant, which supports organizations with technology and services to improve outcomes and lower care costs in diverse business models.
      • “Cone Health’s impressive work for decades in moving value-based care forward aligns so well with Risant Health’s vision for the future of healthcare. Their longstanding success and deep commitment to providing high-quality care to North Carolina communities make them an ideal fit to become a part of Risant Health,” CEO, Jaewon Ryu, MD, said in a June 21 news release. “We will work together to share our industry-leading expertise and innovation to expand access to value-based care to more people in the communities we serve.” 
      • “Cone Health includes four acute-care hospitals, a behavioral health facility, three ambulatory surgery centers, eight urgent care centers and more than 120 physician practices, according to its website. It has more than 13,000 employees and over 700 physicians, along with 1,800 partner physicians.” 
    • Per Healthcare Dive,
      • “Steward Health Care this week pushed back the auction timeline for the sale of its physician group and about half of its hospitals — less than a week before bids were due.
      • “The delay impacts the sale of Arizona and Massachusetts hospitals as well as the St. Joseph Medical Center in Texas. The new deadline for bids is July 15, with an auction following July 18 and a proposed sales hearing on July 31. Steward did not change the timeline for the sale of its other assets.
      • “One expert told Healthcare Dive it was “very possible” Steward would delay the sale timeline again if creditors agreed it was the best business move — especially since the company just re-upped its debtor-in-possession financing, which provides cash to fund operations through restructuring.”
    • and
      • “Telehealth use declined across most sociodemographic groups from 2021 to 2022, according to a survey published Thursday by the National Center for Health Statistics.
      • “Thirty-seven percent of adults reported using telemedicine in the past 12 months in 2021, compared with just over 30% in 2022.
      • “Researchers noted the decline across nearly all groups studied, including sex, family income, education and region. Women, adults with at least a college degree and people living in more urban areas were more likely to use telehealth in 2022.” 
    • Per Fierce Healthcare,
      • “An innovation council brought together some of the nation’s largest health plans to raise issues and look for ways to improve complex processes, including credentialing and provider data management.
      • “It’s one of the first times payers have sat down together to solve these pain points, CAQH CEO Sarah Ahmad told Fierce Healthcare in an interview. The health plan representatives met in-person just one day before AHIP 2024 kicked off in Las Vegas last week.
      • “You don’t see that in healthcare these days,” said Ahmad, whose company assembled the leaders.
      • “CAQH is a provider data management company that works on the provider side to credential and handle directory management, and on the member side to handle coordination of benefits.”
    • HR Dive offers five stories on the rise of wellness benefits.