Midweek Update

CDC

Midweek Update

David Ermer–CDC, Congress, Medical / Rx research, NIH, No Surprises Act, OPM, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington DC,

  • The House Oversight and Accountability Committee held a hearing this morning titled “Oversight of Our Nation’s Largest Employer: Reviewing the U.S. Office of Personnel Management, Pt. II”. The witness was OPM acting Director Rob Shriver.
  • Here are links to the opening statements from the Chairman James Comer (R KY) and Mr. Shriver.
  • Here are links to articles about the hearing from Govexec and Federal News Network.
  • The FEHBlog attended the hearing and he heard Mr. Shriver mention a discussion with a member of Congress about a pending OPM legislative proposal. Here is a link to OPM’s March 24 publication on its FY 2025 legislative proposals. Here is a blurb on the discussed proposal (see p. 36):
    • Beginning in FY 2026, this proposal would allow OPM to access a capped amount of mandatory funding annually from the Employees Health Benefits Fund to develop and maintain eligibility and enrollment systems for PSHB and FEHB. The cap would start at $37 million in 2026 and gradually increase, for a 10-year cost of $474 million. This proposal would provide consistent, stable funding for continued operation of the PSHB eligibility and enrollment system and potential expansion to FEHB.
  • MedPage Today lets us know,
    • “Providing nutritious meals to vulnerable populations can save lives and curb healthcare costs, experts said during a hearingopens in a new tab or window of the Senate Health, Education, Labor, and Pensions (HELP) Subcommittee on Primary Health and Retirement Security on Tuesday.”Providing nutritious meals to vulnerable populations can save lives and curb healthcare costs, experts said during a hearingopens in a new tab or window of the Senate Health, Education, Labor, and Pensions (HELP) Subcommittee on Primary Health and Retirement Security on Tuesday.
    • “Poor nutrition is the top cause of death and disability in the United States … causing more harm than tobacco use, alcohol, physical inactivity, and air pollution,” said Dariush Mozaffarian, MD, DrPH, director of the Food is Medicine Institute at Tufts University in Boston.
    • “What that means, in reality, is that the inability to access healthy food is “literally lethal,” Mozaffarian said. And while thousands of Americans know their diets are making them sick, many feel powerless to fix the problem.
    • “Witnesses argued that food is medicine, which is why produce prescriptions, medically tailored meals, and counseling programs have been shown to substantially benefit patients with diabetes, depression, pain, and other chronic issues.'”
  • Health Affairs Forefront brings us up to date on No Surprises Act developments. Of note,
    • “On April 23, 2024, the Administration released a status update on implementation of the [Advanced Explanation of Benefits] AEOB requirement. The update included a summary of a September 2022 Request for Information (RFI), through which the Administration had sought recommendations on how to exchange data between payers and providers. The Administration received feedback on patient privacy concerns, how surprise billing protections should be represented in the AEOB, exemptions for small and rural providers, and support for underserved and marginalized populations. Most comments also advocated the testing of data standards in real-world settings prior to a national rollout of standards for the data exchange. 
    • “In addition to the RFI, HHS explained that it had studied the needs and capabilities of providers, payers, and third-party vendors such as electronic health records vendors, clearinghouses, and standards development organizations. HHS investigated different kinds of providers and payers to understand existing claims processes, communications channels, and potential financial and operational constraints. Digital service researchers recommended that the Administration propose a single data exchange standard for the receipt of [Good Faith Estimates] GFEs by payers and the transmission of AEOBs from payers to patients to implement those provisions efficiently. * * *
    • “Lastly, the Administration reported that it is “exploring opportunities to promote real-world testing of the implementation guide” being developed by a cost transparency workgroup. HHS emphasized the importance of working with industry partners “to implement an efficient process for creating meaningful protections for patients from unexpected medical bills.”

From the public health and medical research front,

  • MedPage Today tells us,
    • “A Michigan farmworker has been diagnosed with bird flu — the second human case associated with an outbreak in U.S. dairy cows.
    • “The patient had mild symptoms, Michigan health officials said in announcing the case Wednesday. The person had been in contact with cows presumed to be infected, and the risk to the public remains low, officials said.
    • “In a statement, the CDC noted that an initial nasal swab turned up negative for influenza, but an eye swab sent to the agency tested positive for influenza A(H5) virus. Similar to the other U.S. case reported earlier this year [in Texas], the Michigan patient only had eye symptoms.”
  • The Hill reports,
    • “HIV infections in men decreased by an estimated 12 percent in 2022 compared to 2018, according to the latest data from the Centers for Disease Control and Prevention (CDC), with the largest notable decline observed among the youngest age group.
    • “The data published in the CDC’s HIV Surveillance Supplemental Report found there was a 12 percent decrease in HIV incidence between 2018 and 2022 among boys and men aged 13 and older. Among those between the ages of 13 and 24, the drop was 30 percent. * * *
    • “HIV+Hepatitis Policy Institute lamented that while rates of new cases are dropping, they still remain high. The organization noted this current pace keeps the U.S. from reaching its goal of ending the HIV epidemic by 2030 and called for increased investment into this endeavor.”
  • The American Hospital Association News reports,
    • “The AHA May 22 released a new infographic and blog highlighting how increasing drug prices and shortages are jeopardizing patient access to hospital care and exacerbating challenges hospitals are experiencing. The documents show that in 2023 drug companies continued to introduce new drugs at record prices while existing drug prices skyrocketed and consistently outpaced general inflation. The median annual price for new drugs was $300,000, an increase of 35% from the prior year. In addition, the documents highlight how drug shortages were the highest in a decade, and managing drug shortages adds as much as 20% to hospitals’ drug expenses. 
    • “Though the problem of high drug prices is not a new issue for hospitals and health systems, the rate at which drug prices are increasing combined with the problem of drug shortages is becoming unsustainable for the field and having a direct impact on patient outcomes,” the blog notes. “Higher drug prices and increasing drug shortages mean more costs for hospitals and health systems to bear, further stretching their limited resources and ultimately jeopardizing patients’ access to needed care.”
  • The New York Times points out “Despite Setback, Neuralink’s First Brain-Implant Patient Stays Upbeat; Elon Musk’s first human experiment with a computerized brain device developed significant flaws, but the subject, who is paralyzed, has few regrets.”
  • Here’s a link to the National Cancer Institute’s latest Cancer Information Highlights.
  • Per MedTech Dive,
    • “Boston Scientific’s modular cardiac rhythm management system met pre-specified safety and efficacy endpoints in a pivotal clinical trial, the company said Saturday at the Heart Rhythm Society annual meeting.
    • “The company designed the system, which consists of an implantable defibrillator and leadless pacemaker, for people who are at risk of sudden cardiac death from ventricular arrhythmias that existing subcutaneous implantable cardioverter-defibrillators (ICDs) are unable to treat.
    • “J.P. Morgan analysts said Boston Scientific reported “good results” and “solid” safety data, with the trial beating the performance goals for communication success and pacing thresholds.”

From the U.S. healthcare business front,

  • Per Biopharma Dive
    • “Biogen is scooping up a closely held immunology startup to bring more diversity to a pipeline best known for neurology products.
    • “Per deal terms, Biogen will pay $1.15 billion in cash up front to acquire Human Immunology Biosciences, or HI-Bio, and as much as $650 million more if the startup’s lead drug achieves certain milestones. The medicine, felzartamab, has completed Phase 2 trials for two kidney conditions, with a third study ongoing.
    • “The acquisition won’t affect Biogen’s 2024 financial guidance, the company said Wednesday. It plans to finance the purchase with cash and possibly draw on a revolving credit agreement. Biogen expects the transaction to close in the third quarter.”
  • and
    • “Pfizer, already in the midst of an aggressive effort to trim spending, on Wednesday disclosed new plans to cut at least $1.5 billion in additional costs over the next several years. 
    • “The program is meant to reduce what Pfizer spends on producing its medicines and will include “operational efficiencies, network structure changes and product portfolio enhancements,” the company said in a securities filing. 
    • “Given the complexity in manufacturing and longer lead times required to make changes, this program will be a multi-phased effort,” Pfizer added. The $1.5 billion target, which Pfizer expects to be realized by the end of 2027, is associated with the program’s first phase.”
  • Beckers Payer Issues lists seven providers being acquired by payers in 2024.
  • Fierce Healthcare informs us,
    • “Mayo Clinic is partnering with Zipline to provide drone delivery service for medications and supplies directly to patients’ homes as part of its advanced hospital-at-home program.
    • “The health system will integrate Zipline’s Platform 2 drone system into its campuses in Jacksonville, Florida, and Rochester, Minnesota. Mayo Clinic will use Zipline’s zero-emission, autonomous drones for quick deliveries, the organizations announced Wednesday.
    • “Through the drone service, if a caregiver notices a need for an acute medical intervention, Zipline can deliver medications and supplies from the hospital to a person’s home within minutes.
    • “Mayo Clinic’s Advanced Care at Home model has since seen 2,600 patients to date.”

Tuesday Tidbits

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Obesity, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • MedPage Today tells us,
    • Senators and experts on Tuesday examined the range of tools that brand-name drug manufacturers have used to keep generic and biosimilar competition at bay — from patent thickets and product hopping to “pay-for-delay” settlements — and wrestled with how to prevent such abuses.
    • “Too often the prices charged by Big Pharma do not reflect a scientific advancement,” argued Sen. Dick Durbin (D-Ill.), during a Tuesday hearing of the Senate Committee on the Judiciary. “Rather, they’re the result of skilled lawyers manipulating the patent system and skirting our nation’s competition laws.”
  • The Department of Health and Human Services announced,
    • “The Biden-Harris Administration is committed to lowering health care costs, promoting innovation, and making sure that taxpayer investments result in advancements in biomedical research that are accessible to everyone across the country.
    • “Today, the National Institutes of Health (NIH) issued a first of its kind draft policy proposal to promote equitable access to products stemming from NIH-owned inventions. By requiring organizations partnering with the NIH through patent license agreements to outline detailed plans for patient access to drugs, biologics, vaccines, or devices developed from NIH-owned inventions, we are accelerating how breakthroughs in medical research originating from the NIH’s Intramural Research Program can translate into affordable and sustainable solutions for patients across the country. NIH has released a request for information and welcomes public input to inform this new policy.”
  • The American Hospital News informs us,
    • “The Centers for Medicare & Medicaid Services May 21 announced that individuals now have the option to file an Emergency Medical Treatment and Labor Act complaint directly with the agency, in addition to the traditional process of contacting state survey agencies. The new form is the latest in a series of new resources from CMS to help educate the public about EMTALA.” 

From the public health and medical research front,

  • Beckers Hospital Review points out,
    • “The CDC is asking health officials in all 50 states to continue monitoring the prevalence of influenza as H5N1 bird flu infections among poultry and livestock increase and have begun to prompt concern over the possibility of human-to-human transmission, according to a news release shared with Becker’s.”The CDC is asking health officials in all 50 states to continue monitoring the prevalence of influenza as H5N1 bird flu infections among poultry and livestock increase and have begun to prompt concern over the possibility of human-to-human transmission, according to a news release shared with Becker’s.
    • “As of May 21, there has only been one confirmed human infection of the current H5N1 outbreak in a dairy farm employee in Texas, but no evidence of human-to-human transmission.”
  • KFF adds a report titled “Who is at Risk Amid the H5N1 Influenza Outbreak? Characteristics and Health Coverage of Animal Production Workers.”
  • The Blue Cross Blue Shield Association lets us know,
    • “Despite the explosion in demand for weight loss drugs known as GLP-1s, 58% of patients discontinue use before reaching a clinically meaningful health benefit. This is the key finding from new researchreleased by the Blue Cross Blue Shield Association (BCBSA) and conducted by Blue Health Intelligence® (BHI) based on data from nearly 170,000 commercial health plan members since the first FDA approval for a weight-loss GLP-1 in 2014.  
    • “When patients take medication, we want it to be safe and effective,” said Razia Hashmi MD, MPH, FAAFP, vice president of Clinical Affairs at BCBSA. “This study shows most people are unlikely to see lasting benefits.  Unfortunately, weight loss isn’t as simple as filling a prescription.”
    • “In the largest study using commercial data to date on this topic, BHI’s assessment also found that 30% of patients discontinued use of the medications within the first month. 
    • “This study underscores how much more we have to learn about these medications,” said Kim Keck, president and CEO of BCBSA. “The science behind these drugs is moving faster than our ability to truly understand which patients will benefit, how to sustain their success and how to pay for them. If we don’t get it right, we will drive up costs for everyone with little to show for it.” 
  • STAT News reports,
    • “Hundreds of genetic variants can nudge someone’s risk of breast cancer up or down or towards a particular subtype. The studies identifying those gene variants, though, have largely involved people with European ancestry and thus give a less accurate picture of breast cancer risk for people who are not white.
    • “That’s beginning to change. Last week, researchers published a genome-wide association study on breast cancer in roughly 40,000 people of African descent in Nature Genetics, marking a leap forward in scientists’ knowledge of breast cancer genetics in people of African ancestry.
    • “Before we started this study in 2016, there were just several thousand cases for Black Americans. It was a very small number,” said Wei Zheng, the study’s senior investigator and a cancer epidemiologist at Vanderbilt University. This study combined data from dozens of other studies and included genetic data for thousands of new participants, making it the largest combined breast cancer genetics study done with people with African ancestry.
    • “Specifically, the study compiled data from about 30 different studies investigating breast cancer in African or African American people. About 18,000 of them had breast cancer, while the other 22,000 were healthy controls, and investigators were able to scour their genetic data for specific variations that seemed closely related to breast cancer. The statistical power that comes with such numbers enabled the team to make two key advances.
    • “First, the team found 12 loci, or locations in the genome, that showed a significant association with breast cancer. Of those, the team identified variants of three genes that appear to increase the risk of triple negative breast cancer, one of the most aggressive subtypes. Since everyone has two copies or alleles of each gene, that means someone could have anywhere between one and six risk-related alleles of these three genes. Those who had all six risk-related alleles had roughly double the chance of getting triple negative breast cancer than those who only had three. * * *
    • “The other advance came when the researchers used the data to build a breast cancer risk prediction model for people with African ancestry. Such models take into account hundreds of different genetic variants that can slightly push breast cancer risk up, adding them all up into a polygenic risk score.”
  • The Wall Street Journal relates,
    • GSK’s experimental drug for asthma met its goals in the latest trial, moving a treatment with potential annual peak sales of more than 3 billion pounds ($3.81 billion) closer to market.
    • The British pharmaceutical company’s depemokimab drug reduced asthma attacks in late-stage trials for patients with severe eosinophilic asthma, a form of the disease caused by high levels of white blood cells, GSK said Tuesday.
    • Depemokimab could be the first approved drug to allow a long-term dosing interval, requiring only two injections a year. This would benefit patients exposed to multiple therapies, the company said.
    • GSK plans to submit the drug for approval for severe asthma in the U.S. in the second half of the year.
  • Per MedTech Dive,
    • “The Food and Drug Administration is seeking examples of artificial intelligence and machine learning models that can identify and predict freezing of gait events related to Parkinson’s disease. 
    • “Freezing of gait is a temporary loss of forward movement while walking. These episodes affect people’s quality of life and daily activities, but they can be difficult to measure because they often happen when patients are outside of a clinic or hospital setting. 
    • “By testing these models against its own data, the FDA hopes to better understand the ability of these technologies to provide digitally derived endpoints that could help with early disease detection and prevention or support treatment and care in the home.” 
  • From the U.S. healthcare business front,
  • Milliman tells us, “In 2024, the cost of healthcare for a hypothetical American family of four in a typical employer-sponsored health plan is $32,066, according to the Milliman Medical Index (MMI).”
  • The Wall Street Journal reports,
    • “National drugstore chains, once resistant to the retail apocalypse that swept across the U.S., are finally succumbing to competition from online shopping and discount stores.
    • “About 3,000 fewer drugstores were open for business at the start of this year compared with the same period in 2019, according to analytics company RetailStat, which tracks 15 pharmacy chains. 
    • “CVS Health, Walgreens and Rite Aid have each closed hundreds of stores since the onset of the pandemic. Online shopping has been growing and offers customers a more convenient way to buy household staples. 
    • “Competition has also increased from discount retailers such as Walmart, grocers such as Aldi, and dollar stores, which all sell many of the same items at lower prices. The spread of beauty stores such as Sephora further siphoned customers from drugstore aisles. 
    • “Everybody’s gone after a component of their business,” said Henry Fonvielle, president of the real-estate company Rappaport.”
  • STAT News notes that “Reports of telehealth’s death have been greatly exaggerated.”
    • “Virtual care isn’t in trouble. What is in trouble are the aftermarket telehealth solutions that largely function as a virtual extension of our siloed, fragmented health care system. This specific application of virtual care, which we call Telehealth 1.0, has consistently failed to bring meaningful value to patients, clinicians, and purchasers.
    • “In that sense, its collapse is a welcome development. It’s a sign that the market discerns where the real value lies in virtual care, and it validates the evolution from transactional, one-off care to more sophisticated virtual-first models.”
  • Per Healthcare Dive,
    • “UnitedHealth-owned Optum Rx, one of the biggest pharmacy benefit managers in the U.S., is launching a new drug pricing model next year meant to make payers’ spending on pharmaceuticals more predictable.
    • “The model, called Clear Trend Guarantee, combines costs that used to be separated out, including retail pharmacy, home delivery, specialty drug and rebates, into one single per-member price, according to a Monday release.
    • “Clear Trend is value-based, meaning Optum Rx will share in any savings tied to patient outcomes created in the model.”
  • Per Fierce Healthcare,
    • “The Purchaser Business Group on Health has unveiled a new purchasing agreement that aims to improve maternal health.”The Purchaser Business Group on Health has unveiled a new purchasing agreement that aims to improve maternal health.
    • “Benefits experts at retail giant Walmart and technology company Qualcomm led the initiative as co-chairs, with the goal of establishing “a collective commitment among employers and public purchasers of healthcare” to address maternal health and birth equity, according to an announcement from PBGH.
    • “The agreement centers on five key principles: deploying evidence-based, coordinated models to ensure high-quality care; ensuring timely access; promoting equitable care built on cultural humility; transparency and accountability; and value-based care.
    • “It also establishes a consensus for employers and public healthcare purchasers as to what high-quality and high-value maternity care is and outlines expectations for both insurers and providers to follow to meet that bar.”
  • Per BioPharma Dive,
    • “A decade ago, as British drugmaker AstraZeneca fought off a hostile takeover bid by Pfizer, CEO Pascal Soriot made a big promise: The company, he said, would boost sales by nearly three-quarters to reach $45 billion by 2023.”A decade ago, as British drugmaker AstraZeneca fought off a hostile takeover bid by Pfizer, CEO Pascal Soriot made a big promise: The company, he said, would boost sales by nearly three-quarters to reach $45 billion by 2023.
    • “With that goal now successfully met, Soriot on Tuesday announced a plan to push the company even higher, setting a target of $80 billion in annual sales by 2030. A slate of new medicines in metabolic and autoimmune disease headline the plan, which also involves sustaining existing businesses in respiratory disorders and cancer.
  • Beckers Hospital Review calls attention to “Fortune and PINC AI’s “15 Top Health Systems” list released May 21.”
  • McKinsey & Company discusses what’s new in consumer wellness trends.

Friday Factoids

David Ermer–CDC, Congress, FDA, Generative AI, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Govexec tells us,
    • “The Office of Personnel Management on Thursday introduced a new form of paid leave designed for federal workers to use in connection with instances of domestic violence or other sexual or relationship-based trauma.
    • “In a memo to agency heads, acting OPM Director Rob Shriver said that although the federal government’s paid leave system “was not constructed with concepts of safe leave in mind,” the Biden administration is committed to protecting feds who have undergone relationship-based trauma and their families. * * *
    • “According to a new fact sheet on OPM’s website, the new safe leave will fall into a series of pre-existing leave categories, depending on what the federal employee intends to do while on leave.”
  • The Census Bureau announced,
    • “While the nation’s fastest-growing cities continue to be in Sun Belt states, new population estimates show that some of the top gainers are now on the outskirts of metropolitan areas or in rural areas.
    • “Today’s release of U.S. Census Bureau July 1, 2023, population estimates for cities and towns reveals geographic shifts in population growth compared to pre-pandemic July 1, 2019, estimates.
    • “The estimates also show that, on average, many small and midsize U.S. cities with populations under 50,000 saw relatively higher growth rates in 2023 than in 2019 before the pandemic hit while large cities generally grew at slower rates.
    • “Overall, the most populous cities continued to return to pre-pandemic trends thanks to increased growth rates and smaller population declines.”

From the public health and medical research front,

  • The Centers for Disease Control lets us know today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is low nationally. This week, no jurisdictions experienced moderate, high, or very high activity.
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are at low levels.
    • “Nationally, influenza test positivity decreased and RSV and COVID-19 test positivity remained stable at low levels compared to the previous week.
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, is minimal.”
  • CNN reports,
    • “Laboratory tests by the US Department of Agriculture haven’t found any H5N1 bird flu virus in raw beef, but they are a good reminder why eating rare hamburgers can be risky.”Laboratory tests by the US Department of Agriculture haven’t found any H5N1 bird flu virus in raw beef, but they are a good reminder why eating rare hamburgers can be risky.
    • “As part of a suite of tests conducted to check safe food handling advice after the detection of H5N1 bird flu virus in dairy cattle, the USDA recently mixed a substitute virus into ground beef and then cooked patties at varying times and temperatures.
    • “Researchers found none of the virus in hamburgers cooked to 145 degrees, roughly the temperature of a medium burger, or well-done burgers cooked to 160 degrees. They did, however, find some live virus in patties cooked to 120 degrees or rare, although the virus was present “at much, much reduced levels,” said Eric Deeble, acting senior adviser for highly pathogenic avian influenza at the USDA.
    • “Whether that small amount of virus could make someone sick is still an unknown.
    • “The USDA already advises consumers to cook ground beef to an internal temperature of 160 degrees, as measured with a food thermometer, to avoid infections from bacteria such as salmonella and E. coli, he noted.
    • “I don’t think that anybody needs to change any of the safe food handling or safe cooking practices that are already recommended,” Deeble said.”
  • BioPharma Dive lets us know,
    • “New data from two late-stage studies of an experimental Bayer drug show it reduced the frequency and severity of common symptoms of menopause, supporting the company’s case for seeking regulatory approval.
    • “The results were disclosed by Bayer Thursday and will be presented at this year’s annual meeting of the American College of Obstetricians and Gynecologists in San Francisco.
    • “Bayer shared the trials’ success in January, but didn’t reveal specific findings. The company also announced positive results from a third Phase 3 study in March, when it confirmed plans to file for marketing authorization of the drug.
    • “Known as elinzanetant, Bayer’s drug would, if approved, compete with a medicine from Astellas called Veozah, which is approved in the U.S. to treat moderate-to-severe vasomotor symptoms caused by menopause.”
  • The New York Times reports,
    • “When a patient with a severe traumatic brain injury is comatose, in intensive care, unresponsive and hooked up to a ventilator, but not brain-dead, when is the time to withdraw life support? A small study on the fates of people in such situations suggests that doctors and patients’ families may make better decisions if they wait even a few days longer than usual.
    • “Often, a doctor sits down with family members within 72 hours of the patient’s admission to intensive care to discuss the patient’s prognosis, and whether they want to keep their loved one alive, or to remove life support.
    • “Experts say that many doctors would describe the outlook as grim — most likely death or severe disability. Reported outcomes of patients who had severe traumatic brain injuries show that most times the decision is to remove life support. The patient dies.
    • “The researchers behind the new study say that their limited data suggests that doctors’ predictions so soon after the injury frequently are wrong.
    • “The study, published Monday in Journal of Neurotrauma, used a national database that included 1,392 traumatic brain injury patients.”
  • The Wall Street Journal points out that “A ‘Digital Twin’ of Your Heart Lets Doctors Test Treatments Before Surgery. Researchers create digital replicas of individual patients’ organs using data from exams and wearable devices: ‘You can run an infinite number of experiments’.”
    • “Kristin Myers, a mechanical engineering professor at New York’s Columbia University, is making digital copies of women’s uteruses and cervixes, hoping this can help in determining how a pregnancy will go. To do this, Myers uses an ultrasound to create 3-D computational models as part of an effort to someday solve the problem of preterm births. 
    • “The idea of digital twins in health is new,” she says. “We can offer better diagnoses. You can run an infinite number of experiments.”  
    • “At the National Cancer Institute, Emily Greenspan, a program director in the informatics and data science program, envisions a novel way to treat oncology patients. Instead of trying a drug and hoping it works, doctors would create a digital twin of the patient to predict how the disease would respond to a certain drug. 
    • “The institute has been working on creating virtual twins for best treatments of lung cancer, for instance. In the next five years the technology will likely become part of clinical decision-making, Greenspan says. 
    • “Predicting the best treatments and screening, these are blue-sky visions,” she said. “There is a lot of foundational research that’s needed.”
  • Amazing.

From the U.S. healthcare business front,

  • Beckers Payer Issues informs us,
    • “Employer adoption of ICHRAs is up 29% since 2023, according to a May 16 report from the HRA Council.
    • “ICHRAs, or individual coverage health reimbursement arrangements, allow employers to offer a defined tax-advantaged contribution used to reimburse premiums for an individual health plan purchased by an employee on their state’s ACA exchange.
    • “Key numbers:
      • “1. ICHRA adoption grew 29% year over year between 2023 and 2024.
      • “2. ICHRAs grew 84% among employers with 50 or more employees.
      • “3. Among employers surveyed, 83% were not able to offer health benefits until they offered an ICHRA or Qualifying Small Employer HRA. 17% of employers switched from traditional group coverage.
      • “4. The number of employees offered a defined contribution health benefit now exceeds 200,000, which does not include dependents — some estimates have said more than 500,000 people are enrolled.”
  • Per Fierce Healthcare,
    • “For women who experience musculoskeletal (MSK) and pelvic health issues, the decline in estrogen during menopause can not only worsen existing symptoms but also trigger new joint, muscle and pelvic health issues.
    • “Research shows 71% of women who go through menopause experience joint and muscle pain.
    • “Digital health company Hinge Health expanded its movement- and behavior-based care to help women alleviate common menopause symptoms such as hot flashes, joint and muscle pain and pelvic floor disorders.             
    • “As part of the new movement-based menopause support offering, a physical therapist-led care team provides individuals with personalized exercise therapy and behavior-based lifestyle modifications. The aim is to alleviate joint and muscle pain, maintain muscle mass and bone density, and address vasomotor symptoms like hot flashes and mood swings, according to the company.
    • “Regular physical activity can reduce the frequency and severity of some disruptive symptoms that occur with menopause,” said Tamara Grisales, M.D., an urogynecologist at Hinge Health. “Exercise-focused programs complement traditional treatments like Hormone Replacement Therapy, providing a holistic approach to managing menopause.”
  • Beckers Hospital Review notes,
    • “Walgreens will sell a low-cost, over-the-counter version of the opioid overdose antidote naloxone, the company said May 15. 
    • “The Walgreens-brand nasal spray medication will retail for $34.99, a lower price than other branded versions of the drug (Narcan) sold by the retailer. The naloxone spray is currently available online and will hit store shelves nationwide by the end of the month.”

Thursday Miscellany

David Ermer–AHRQ, CDC, Congress, FDA, Medical / Rx research, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Hill informs us,
    • “Blockbuster weight-loss drug Wegovy could bankrupt the U.S. health care system unless the price drops, according to a staff report released Wednesday from the office of Senate Health Committee Chair Bernie Sanders (I-Vt.). 
    • “Unless prices dramatically decline, Wegovy and weight loss drugs could push Americans to spend $1 trillion per year on prescription drugs, the report concluded.
    • “Pricing drugs based on their value cannot serve as a blank check, or the sole determinant for how we understand what to pay for essential goods,” the report stated. As important as these drugs are, they will not do any good for the millions of patients who cannot afford them.” 
    • “The report ups the pressure from Sanders on Danish drugmaker Novo Nordisk to lower the price of Wegovy and Ozempic.”
  • The good Senator has a point here. Drug manufacturers need a dose or two of price reasonableness.
  • STAT News reports,
    • “A House subcommittee on Thursday advanced legislation that would extend some pandemic-era telehealth policies in Medicare for two years, bringing the panel’s approach in line with another committee.
    • “During the pandemic, Congress extended flexibilities that changed what kinds of care Medicare beneficiaries could receive over telehealth and where. Originally, the House Energy and Commerce health subcommittee had considered a bill that would have enacted the policies permanently, but amended the legislation Thursday to pare it down to a two-year extension. The bill passed to the full committee unanimously on a 21-0 vote.
    • “The approach is in line with that of another panel, the House Ways and Means Committee, which passed a two-year extension earlier this month. Both bills include similar provisions that would pay for the extension in part through reforms to the way in which pharmacy middlemen operate.”
  • American Hospital Association News shares,
    • “The AHA shared a series of proposals to strengthen rural health care with the Senate Finance Committee for a hearing May 16 titled, “Rural Health Care: Supporting Lives and Improving Communities.” The proposals include policies promoting flexible payment options; ensuring fair, timely and adequate reimbursement; bolstering the workforce; and improving maternal health. During the hearing, several members focused on access to obstetric services and augmenting the number of medical residency slots awarded to rural hospitals. Jeremy P. Davis, MHA, president and CEO of AHA-member Grande Ronde Hospital in La Grande, Ore., and other health care leaders and policy researchers testified.”
  • The Department of Health and Human Services celebrates the Administration’s mental healthcare accomplishments.
  • The New York Times reports,
    • “The Food and Drug Administration on Thursday approved an innovative new treatment for patients with a form of lung cancer. It is to be used only by patients who have exhausted all other options to treat small cell lung cancer, and have a life expectancy of four to five months. * * *
    • “Each year, about 35,000 Americans are diagnosed with small cell lung cancer and face a grim prognosis. The cancer usually has spread beyond the lung by the time it is detected. * * *
    • “The drug tarlatamab, or Imdelltra, made by the company Amgen, tripled patients’ life expectancy, giving them a median survival of 14 months after they took the drug. Forty percent of those who got the drug responded.
    • “After decades with no real advances in treatments for small cell lung cancer, tarlatamab offers the first real hope, said Dr. Anish Thomas, a lung cancer specialist at the federal National Cancer Institute who was not involved in the trial.
    • “I feel it’s a light after a long time,” he added.”
  • Tammy Flanagan, writing in Govexec, discusses FEHB annuitant reactions to Part D EGWP offerings in various FEHB plans for 2024.
  • Federal News Network notes,
    • After a couple years of uncertainty, satisfaction among federal employees is beginning to rise at many agencies.
    • In a preview of the latest Best Places to Work in the Federal Government rankings, out of the top 10 agencies in each of the four categories — large, midsize and small agencies, as well as agency subcomponents — prioritizing employee engagement was the common thread, the Partnership for Public Service said.
    • “At a time when our nation faces both critical challenges and exciting opportunities at home and abroad, an engaged federal workforce is vitally important,” Max Stier, president and CEO of the Partnership for Public Service, said in a statement. “The top-ranked agencies have excelled at keeping their workforces engaged and motivated and, as a result, they are well positioned to deliver results for the public.” * * *
    • “The Environmental Protection Agency, Energy Department, Office of Personnel Management and National Credit Union Administration all moved up in the rankings and increased their overall scores.” 
  • The CDC is promoting its new and improved website.

From the public health and medical research front,

  • The New York Times informs us,
    • “With Pride events scheduled worldwide over the coming weeks, U.S. officials are bracing for a return of mpox, the infectious disease formerly called monkeypox that struck tens of thousands of gay and bisexual men worldwide in 2022. A combination of behavioral changes and vaccination quelled that outbreak, but a majority of those at risk have not yet been immunized.
    • “On Thursday, the Centers for Disease Control and Prevention warned of a deadlier version of mpox that is ravaging the Democratic Republic of Congo and urged people at risk to be vaccinated as soon as possible. No cases of that subtype have been identified outside Africa so far. But the escalating epidemic in Congo nevertheless poses a global threat, just as infections in Nigeria set off the 2022 outbreak, experts said.
    • “This is a very important example of how an infection anywhere is potentially an infection everywhere, and why we need to continue to improve disease surveillance globally,” said Anne Rimoin, an epidemiologist at the University of California, Los Angeles. * * *
    • “The C.D.C. is focusing on encouraging Americans at highest risk to become vaccinated before the virus resurges. The agency’s outreach efforts include engaging with advocacy groups and social media influencers who have broad appeal among the L.G.B.T.Q. community. In December, the agency urged clinicians to remain alert for possible cases in travelers from Congo.”
  • and
    • “Heart disease, diabetes and kidney disease are among the most common chronic illnesses in the United States — and they’re all closely connected.
    • “Adults with diabetes are twice as likely to have heart disease or a stroke compared with those who don’t have diabetes. People with diabetes — Type 1 and Type 2 — are also at risk of developing kidney disease. And when the kidneys don’t work well, a person’s heart has to work even harder to pump blood to them, which can then lead to heart disease.
    • “The three illnesses overlap so much that last year the American Heart Association coined the term cardiovascular-kidney-metabolic syndrome to describe patients who have two or more of these diseases, or are at risk of developing them. A new studysuggests that nearly 90 percent of American adults already show some early signs of these connected conditions.
    • “While only 15 percent of Americans meet the criteria for advanced stages of C.K.M. syndrome, meaning they have been diagnosed with diabetes, heart disease or kidney disease or are at high risk of developing them, the numbers are still “astronomically higher than expected,” said Dr. Rahul Aggarwal, a cardiology fellow at Brigham and Women’s Hospital in Boston and co-author of the study.
    • “The research suggests that people should pay attention to shared risk factors for these diseases early on — including excess body fat, uncontrolled blood sugar, high blood pressure and high cholesterol or triglyceride levels.”
  • BioPharma Dive points out,
    • “An experimental Roche drug helped people with obesity lose an average of nearly 19% of their body weight over six months, after adjusting for placebo, in an early-stage trial, the company said Thursday.
    • “Roche is awaiting additional data from a study of the drug, called CT-388, in people with diabetes as well as obesity. It also didn’t provide specifics on the drug’s side effect profile. CT-388 is currently only in a Phase 1 program involving 96 people. Larger and longer trials are needed before the company can ask the Food and Drug Administration for approval.
    • “Roche acquired CT-388 through a $2.7 billion acquisition of biotechnology startup Carmot Therapeutics in December. The deal was part of a rush by pharmaceutical companies to capture a share of a market estimated to be worth more than $100 billion annually by early next decade.”
  • and
    • “A once-weekly form of insulin being developed by Eli Lilly proved just as effective at controlling blood sugar in adults with diabetes as commonly used daily injections, according to results from two clinical trials that were released by the drugmaker Thursday.”A once-weekly form of insulin being developed by Eli Lilly proved just as effective at controlling blood sugar in adults with diabetes as commonly used daily injections, according to results from two clinical trials that were released by the drugmaker Thursday.
    • “Lilly is betting that its experimental drug, dubbed insulin efsitora alfa, could provide a longer-lasting and more convenient option than daily treatment for managing diabetes. 
    • “With efsitora, we have an opportunity to provide an innovative once-weekly solution that safely achieves and maintains A1C control, reduces treatment burden of traditional daily injections and potentially improves adherence for people with diabetes,” said Jeff Emmick, a senior vice president of product development for Lilly, in a statement on the trial results.” 
  • The National Institutes of Health Director, in her blog, discusses “Speeding the Diagnosis of Rare Genetic Disorders with the Help of Artificial Intelligence.”
  • The National Institutes of Health announced,
    • “People were more likely to develop a type of treatment-resistant hypertension when they experienced adverse effects of economic and social conditions that influence individual and group differences in health status, known as social determinants of health. Additionally, this risk was higher among Black American adults than white American adults, according to a study funded by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.”People were more likely to develop a type of treatment-resistant hypertension when they experienced adverse effects of economic and social conditions that influence individual and group differences in health status, known as social determinants of health. Additionally, this risk was higher among Black American adults than white American adults, according to a study funded by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.
    • “Factors linked to this increased risk included having less than a high school education; a household income less than $35,000; not seeing a friend or relative in the past month; not having someone to care for them if ill or disabled; lack of health insurance; living in a disadvantaged neighborhood; and living in a state with low public health infrastructure. Apparent treatment-resistant hypertension is defined as the need to take three or more types of anti-high blood pressure medication daily and is associated with an increased risk for stroke, coronary heart disease, heart failure, and all-cause mortality.”
  • The U.S. Preventive Services Task Force released a final research plan for “Unhealthy Alcohol Use in Adolescents and Adults: Screening and Behavioral Counseling Interventions.”
  • Beckers Hospital Review alerts us,
    • “In 2023, patient falls were once again the most common sentinel event reported by healthcare organizations, according to a May 15 report from The Joint Commission.
    • “The Joint Commission defines a sentinel event as a patient safety event that results in death, permanent harm, severe temporary harm or intervention required to sustain life.
    • “The accrediting body received 1,411 reports of sentinel events in 2023, on par with the volume reported in 2022. Only a small portion of all sentinel events are reported to The Joint Commission, meaning conclusions about the events’ frequency and long-term trends should not be drawn from the dataset, the organization said.
    • “In total, 96% of healthcare organizations voluntarily reported sentinel events. About 18% of events were associated with patient death, 8% with permanent harm or loss of function, 57% with severe temporary harm and 12% with unexpected additional care or extended healthcare stays.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “One reason U.S. inflation is still high: Increases in prices for procedures to prop open clogged arteries, provide intensive care for newborns and biopsy breasts.
    • “Hospitals didn’t raise prices as early in the pandemic as supermarkets, retailers and restaurants. But they have been making up ground since then. Their increases have contributed to stubbornly high inflation readings from the consumer-price index, which in April increased 3.4% from a year ago. 
    • “Hospital prices specifically jumped 7.7% last month from a year ago, the highest increase in any month since October 2010, the Labor Department said Wednesday. * * *
    • Economists said they expect higher hospital inflation to persist as recent years’ labor-market disruption continues to ripple through wages and health-insurance contracts. 
    • “We’re not expecting much slowing,” said Alan Detmeister, an economist for UBS. “This was a very large shock that we saw in the healthcare industry over Covid, and it takes years for those to pass through to the prices.”
    • Hospital price increases are responsible for about 23% of the growth in U.S. health spending each year, on average, according to an analysis by federal actuaries for the Journal. Health-insurance premiums last year shot up at the fastest rate in a decade. 
    • Premiums rise with health spending. Public employees in California saw premiums increase 11% this year, largely because of rising prices, which alone raised their premiums by 8%, said the California Public Employees’ Retirement System. 
  • Healthcare Finance adds,
    • The Centers for Medicare and Medicaid Services’ January [2024] expansion of the two-midnight rule to include Medicare Advantage plans has contributed to higher inpatient volumes and revenue growth in the first quarter of the year, according to a Strata Decision Technology report.
    • This is because inpatient services have higher reimbursement levels compared to outpatient services and the two-midnight rule concerns inpatient care.
  • Per Fierce Healthcare,
    • “Though held in check by inflation, Cleveland Clinic’s first-quarter operations trickled past last year’s tally thanks to a jump in volumes and revenues.
    • The nonprofit system reported this week a $50.2 million operating gain (1.3% operating margin), as opposed to the prior year’s $32.3 million (0.9% operating margin). Operating revenues rose 10.2% year over year to nearly $3.9 billion while operating expenses followed close behind with a 9.8% increase.
    • “Cleveland Clinic enjoyed “strong demand for both inpatient and outpatient services” during the quarter, management wrote in commentary on its operations. Compared to the prior year, acute admissions rose 6.7%, total surgical cases by 3.7% and outpatient evaluation and management visits by 3.9%.
    • “The system’s 9.4% increase in net patient service revenue was also boosted by rate increases among Cleveland Clinic’s managed care contracts that went into effect with the new year. Additionally, management wrote, “over the last few years, the system initiated national, regional and local revenue management projects designed to improve patient access throughout the system while striving to ensure the safety of patients, caregivers and visitors.”
  • According to Healthcare Dive,
    • “[Philadelphia based] Jefferson Health and [Allentown, PA, based] Lehigh Valley Health Network signed a definitive agreement Wednesday to merge. The health systems expect the deal to close later this summer, pending regulatory approval, according to a press release. Deal terms were not disclosed.”
  • Fierce Healthcare adds,
    • “UnitedHealth Group’s investments in affordable housing have topped $1 billion, with the program a keystone in its overarching strategy to address health equity and disparities.
    • “The company has made investments in housing since 2011 and, in that time, has supported the development of affordable and mixed income units across 31 states and the District of Columbia, creating more than 25,000 homes for people and families who face housing insecurity.
    • “The investments include direct funding from the company as well as those made through Low-Income Housing Investment Tax Credits and Community Reinvestment Act loans, UnitedHealth said. The company has backed both new development and rehabilitation for older locations in urban, suburban and rural markets. * * *
    • “UnitedHealth is tracking the health benefits of these investments and spent two years measuring outcomes against a baseline set by Stewards of Affordable Housing for the Future and the National Affordable Housing Trust. It found that people living in the properties it backed were more likely to receive annual checkups, with 95% having one in the past year.
    • “In addition, residents living in these locations reported better mental health compared to low-income individuals across the country.”

Tuesday Tidbits

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Govexec lets us know,
    • “The U.S. Postal Service is pausing some of the most controversial reforms to its mailing network as its leadership has agreed to the demands of a growing, bipartisan chorus in Congress. 
    • “The mailing agency has halted its plans to consolidate dozens of processing facilities until at least Jan. 1, 2025, ensuring the network overhaul is paused until after the upcoming presidential election in which millions of Americans will be voting by mail. A large swath of lawmakers across the ideological spectrum have called on Postmaster General Louis DeJoy to delay or cease the changes, some of which would shift the bulk of mail processing across state lines. 
    • “The decision marks a reversal for DeJoy, who just last week remained resolute in defending his vision as the only viable path forward for his agency. He called the issue an existential one, saying his reforms were “what we must continue to do to survive.” 
  • HHS’s Agency for Healthcare Research and Quality posted its March 2024 “NATIONAL HEALTHCARE QUALITY AND DISPARITIES REPORT CHARTBOOK ON PATIENT SAFETY.”
  • Per an FDA press release, “[o]n Monday [May 13], the FDA issued a safety communication to warn patients, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests due to an increased risk of false results. The FDA had also issued a Warning Letter to Cue Health after an inspection revealed that the company made changes to these tests and that the changes reduced the reliability of the test to detect SARS-CoV-2 virus.” 

From the public health and medical research front,

  • The Washington Post reports,
    • “The coronavirus has once again evolved, in a familiar echo of past years. Unlike earlier iterations of the virus, this new variant is not sparking widespread havoc.
    • “The Centers for Disease Control and Prevention said it is monitoring a variant called KP.2 and does not see evidence it causes more severe illness than other strains. Laboratory tests have shown that KP.2 is not causing a surge in infections or transmission, the agency said.
    • “The CDC has identified a second emergent variant, KP.1.1. But it is KP.2 that is leading the pack. Both new variants belong to a group of coronavirus variants dubbed “FLiRT” by scientists. The acronym was coined to describe a combination of mutations found in the spike protein of the SARS-CoV-2 virus. * * *
    • “KP.2 has symptoms similar to earlier versions of the virus, including fever, chills, cough and muscle or body aches.”
    • The current vaccines are effective against KP.2. [“H]ealth experts predict that the new formulation of the coronavirus expected for the fall could offer even stronger protection because it will probably be tailored to thwart the new variant.”
  • Beckers Hospital News informs us,
    • “On average, people taking Novo Nordisk’s weight loss drug Wegovy see a 10% reduction in weight, which is sustained for four years, according to findings from a major trial published May 13.  * * *
    • “Wegovy is tied to a 20% reduced risk of heart attacks and other cardiovascular events — a benefit that was seen across the board, irrespective of how much weight people lost.” 
  • STAT News adds,
    • “Novo Nordisk will test whether its GLP-1 drugs can help people with alcohol-associated liver disease, and, as part of that, will study if the treatments will change the amount of alcohol people drink.
    • “This appears to be the first time the company is getting involved in research to see if the booming class of GLP-1 diabetes and obesity drugs can affect substance consumption, a question that academic researchers have been probing but the pharmaceutical industry has so far avoided.
    • “The nine-month study will try three drugs alone and in combinations against placebo. The primary outcome being tested is change in liver scarring, or fibrosis, and one of the secondary outcomes is changes in alcohol consumption. The news of the study was first reported by Bloomberg.
    • “The medications that will be tested include the blockbuster semaglutide, sold as the diabetes drug Ozempic and obesity drug Wegovy, as well as CagriSema, a drug Novo is developing that combines semaglutide with the dual amylin and calcitonin receptor agonist cagrilintide. A third drug, NNC0194-0499, targets FGF-21, a hormone produced by the liver that plays a role in inflammation.”
  • NIH’s All of Us Program posted its latest newsletter.
  • Per an Institute for Clinical and Economic Research press release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of 3,4-Methylenedioxymethamphetamine-assisted psychotherapy (MDMA-AP; Lykos Therapeutics) for the treatment of post-traumatic stress disorder (PTSD). * * *
    • “Key Clinical Findings
    • “Although ICER attempted to explore the concerns raised about MDMA-AP and the MAPP trials, ICER was not able to assess the extent that bias influenced reporting of benefits or the frequency with which there may have been misreporting of harms. As such, ICER concluded that the current publicly available evidence is insufficient (“I”) to assess the overall net benefit of MDMA-AP. 
    • “Key Cost-Effectiveness Findings
    • “Given the “I” rating, the economic analyses of MDMA-AP in this Evidence Report are only exploratory analyses that provide insights into costs and benefits if it is assumed that the results of the MAPP trials are accurate. ICER did not calculate a health-benefit price benchmark for MDMA-AP.”
  • Benefitfocus released an “Employee Benefits Strategy Playbook for Mental Healthcare.

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “The majority of the nation’s leading for-profit hospital systems by revenue reported net gains during the first quarter led by stronger than expected inpatient volumes.
    • “The boost in inpatient volumes and associated revenue comes just a quarter after providers said they would be betting more heavily on outpatient services to drive growth. 
    • “Increases in inpatient revenues is an area to watch as providers weigh whether and how to adjust their portfolios. Community Health Systems, for example, has been on a selling spree recently in an attempt to deleverage its balance sheets, while HCA Healthcare, Tenet Healthcare and Universal Health Services are expanding services in key markets. 
    • “Should inpatient care utilization continue to rise over multiple quarters, it could influence hospitals’ capital spending, according to research notes from analysts.”
  • BioPharma Dive tells us,
    • “Biosimilars are gaining ground. The IRA could push them further next year.
    • “As commercial momentum builds, coverage incentives for the Medicare market are expected to favor biosimilars in 2025.”
  • Modern Healthcare reports,
    • Behavioral health provider Talkspace rolled out services Tuesday to 13 million Medicare members across 11 states and will expand to 33 million members nationwide by the end of the year.
    • Talkspace services are available to those with traditional Medicare in California, Florida, New York, Ohio, New Jersey, Virginia, Missouri, Maryland, South Carolina, New Mexico and Idaho. The company plans to offer services to Medicare Advantage members later on, as well.

Monday Roundup

David Ermer–CDC, Congress, Medical / Rx research, Obesity, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Fierce Healthcare tells us
    • “A slew of bills targeting enhanced access to care within rural communities have, to the applause of the hospital industry, passed through committee to the full House of Representatives.
    • “The rural care bills that made it through the Ways and Means Committee’s Wednesday markup broadly support the financial stability of designated Critical Access Hospitals (CAHs) and Rural Emergency Hospitals (REH) along with other smaller hospitals serving rural communities [, among other objectives discussed in the article].
    • “These included The Preserving Emergency Access in Key Sites Act of 2024 (PEAKS Act), which expands increased emergency ambulance services coverage for patients served by CAHs; The Rural Hospital Stabilization Act, which authorizes new grants funding for investments into CAHs, REHs and small rural hospitals staving off potential closure; and The Second Chances for Rural Hospitals Acts, which expands the eligibility requirements for low-volume hospitals that wish to become REHs.”
  • Per an HHS press release,
    • “Today, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced the winners of the FentAlert Challenge, which sought innovative ideas from U.S. youth, aged 14-18, to develop a community strategy to educate their peers about fentanyl and fake pills ― and prevent drug overdose deaths. The Challenge supports primary prevention efforts prioritized in the Department of Health and Human Services (HHS) Overdose Prevention Strategy, a key element of the Biden-Harris Administration’s Unity Agenda’s focus on beating the opioid crisis. The Challenge received almost 200 entries from across the country.
    • “The announcement launched National Prevention Week (NPW) (May 12-18), which celebrates the possibilities of prevention science and offers a platform to showcase substance use prevention activities across the country.”
  • Federal News Network lets us know,
    • “The nation’s top doctor is prescribing more attention to federal employees’ mental health and well-being.
    • But now in a hybrid work environment, that task has become remarkably more challenging, U.S. Surgeon General Vivek Murthy said.
    • “I do think that there are a lot of positives to having flexibility to be able to work from home — reduced commute times, time with family, being able to pick your kids up from school, be home for family dinner, while also not sacrificing your work,” Murthy said Thursday during a mental health and wellness event at the Office of Personnel Management. “But I think one of the things we also have to realize is that all of these choices come with trade-offs.”
    • “One of those trade-offs, he said, is that it can become harder to build social connections among coworkers — something that’s crucial for an agency’s operations overall.
    • “When people feel connected to other people in the workplace, that actually positively impacts their creativity, their productivity, and ultimately contributes to their engagement and retention,” Murthy said. “Creating opportunities for people to come back in person periodically, creating more intentional opportunities for people to be able to connect and learn about one another virtually, those become increasingly important when you’re in a hybrid work environment.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Do you know how old your heart is? And does it even matter? 
    • “More online calculators, wearable devices and medical tests are attempting to estimate your heart’s age. The companies and organizations behind the tools say that having insight into your heart health can prompt you to make lifestyle changes to help stave off cardiovascular disease down the road.
    • “It’s an extension of our newfound obsession with “biological age,” the concept that your body, or parts of it, can be physically aging faster or slower than your actual age. And that by knowing those ages, you can take control to live longer and healthier. 
    • “As for the heart, scientists say the tools can be a helpful jumping-off point for conversations with doctors about habit changes or medications before heart disease sets in. 
    • But you should take the results with a grain of salt, doctors and researchers say. The age calculations tend to be imprecise and don’t capture all of your possible risk factors, such as family history, air pollution, pregnancy complications or genetic variations. 
    • “It’s pretending to quantify something for you specifically that is just directionally true,” says Dr. Gregory Katz, a cardiologist at NYU Langone Heart. “It’s based on a true story, but it’s not actually a true story.”
  • Bloomberg Prognosis discusses “advances in treating brain cancer using different forms of immunotherapy — CAR-T, which uses engineered T-cells, and a messenger RNA-based therapeutic vaccine.”
  • Bloomberg also notes,
    • “Patients could wean themselves off blockbuster drugs such as Ozempic or Wegovy without piling the pounds back on, according to a scientific study.
    • “Data [from a small study] presented at the European Congress on Obesity in Venice, Italy on Sunday provides some of the first evidence that it could be possible to stop taking Novo Nordisk’s Ozempic or Wegovy and not regain any weight that has been lost — as long as a healthy lifestyle is maintained. * * *
    • “The Danish study of patients using semaglutide, which is the active ingredient in Ozempic and Wegovy, alongside a weight management program run through the Embla app, suggests that tapering the drug — instead of a hard stop — could potentially prevent weight regain. 
    • “However, just 353 patients were in the sample of patients who stopped semaglutide, which is a small study size. These patients had reached their target weight and reduced their semaglutide dose over nine weeks. Patients continued to lose weight as they tapered, losing an average of 2.1% over the nine weeks. * * *
    • “The combination of support in making lifestyle changes and tapering seems to allow patients to avoid regaining weight after coming off semaglutide,” said Henrik Gudbergsen, lead researcher and Embla’s chief medical officer, in a statement.”
  • STAT News informs us,
    • “Reluctance among dairy farmers to report H5N1 bird flu outbreaks within their herds or allow testing of their workers has made it difficult to keep up with the virus’s rapid spread, prompting federal public health officials to look to wastewater to help fill in the gaps.
    • “On Tuesday, the Centers for Disease Control and Prevention is expected to unveil a public dashboard tracking influenza A viruses in sewage that the agency has been collecting from 600 wastewater treatment sites around the country since last fall.
    • “The testing is not H5N1-specific; H5N1 belongs to the large influenza A family of viruses, as do two of the viruses that regularly sicken people during flu season. But flu viruses that cause human disease circulate at very low levels during the summer months. So the presence of high levels of influenza A in wastewater from now through the end of the summer could be a reliable indicator that something unusual is going on in a particular area.
    • “Wastewater monitoring, at least at this stage, cannot discern the sources — be they from dairy cattle, run-off from dairy processors, or human infections — of any viral genetic fragments found in sewage, although the agency is working on having more capability to do so in the future.”
  • The Washington Post offers Consumer Reports guidance on how to reduce your exposure to plastics in food (and elsewhere).

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Kaiser Permanente kicked off 2024 with $935 million of operating income (3.4% operating margin) and over $2.7 billion of net income when excluding a one-time, $4.6 billion net asset gain from its Geisinger Health acquisition, according to topline first-quarter numbers shared late Friday.
    • “The performance handily outpaces the $233 million operating income (0.9% operating margin) and $1.2 billion bottom line of last year’s opening quarter.
    • “Still, the integrated nonprofit noted that its operating income was still “below historical first-quarter trends leading up to the pandemic” due to industry-wide cost pressures around high utilization, care acuity and elevated goods and services expenses. The top of the year is typically bolstered by the timing of the open enrollment cycle, and then followed by steady revenue but rising expenses, the organization explained.”
  • RAND reports
    • “Prices paid to hospitals during 2022 by employers and private insurers for both inpatient and outpatient services averaged 254 percent of what Medicare would have paid, with wide variation in prices among states, according to a new RAND report.
    • “Some states (Arkansas, Iowa, Massachusetts, Michigan, Mississippi) had relative prices under 200 percent of Medicare, while other states (California, Florida, Georgia, New York, South Carolina, West Virginia, Wisconsin) had relative prices that were above 300 percent of Medicare.
    • “Even as the number of hospitals and insurance claims analyzed has grown across multiple rounds of the RAND Hospital Price Transparency Study the state-level average price has remained above 200 percent of Medicare—from 247 percent of Medicare prices in 2018 to 224 percent in 2020 and to 254 percent in 2022.”
  • Fierce Healthcare also points out
    • “Foley & Lardner released a new state survey of telehealth insurance laws that tracks the changes in the legal landscape from 2019, before the COVID-19 public health emergency, until April 2024.
    • “The survey includes key figures on each state’s telehealth commercial insurance coverage and payment/reimbursement laws.
    • “Nearly all states have adopted a telehealth statute as of April 2024. Of particular note is the number of states that expanded audio-only coverage, states that implemented coverage and payment parity for mental and behavioral health provided via telehealth, and states that passed reimbursement and parity laws.” 
  • Following up on Cybersecurity Saturday, Fierce Healthcare noted earlier today,
    • “Ascension said it is communicating with several government organizations and for the first time referred to its cybersecurity event as a “ransomware incident” in an update posted this weekend. 
    • “The 140-hospital health system said that it is still working to investigate and restore its systems—a process that is “making progress” but “will take time to complete” across each of its care sites. 
    • “In the meantime, the system said it has notified law enforcement and other government bodies including the FBI, the Cybersecurity and Infrastructure Security Agency (CISA) and the Department of Health and Human Services, among others.” 

Friday Factoids

David Ermer–CDC, Congress, COVID-19 vaccine, Employee Wellness Programs, FDA, Generative AI, Medical / Rx research, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Govexec reports,
    • “In the face of mounting pressure from lawmakers of all political stripes, watchdogs, stakeholders and even members of its own governing board, as well as another financial quarter in the red, leadership of the U.S. Postal Service is doubling down on its controversial plan to overhaul the agency. 
    • “USPS posted a net loss of $1.5 billion in the second quarter of fiscal 2024, though management noted that was trimmed to a $300 million loss after dispensing with costs outside of its control. USPS leaders boasted they have turned a $200 million profit in the first half of the fiscal year using that same metric, which marked a $600 million turnaround compared to the first six months of fiscal 2023.
    • “While First-Class mail volume has continued its longstanding decline, revenue grew in the quarter by nearly $500 million due in large part to the dramatic price increases USPS has instituted. The Postal Service has cut $100 million in costs, driven largely by a reduction in transportation expenses and slashing 9 million work hours. 
    • “On-time delivery of mail, however, has plummeted as USPS has instituted significant reforms to its network as laid out in Postmaster General Louis DeJoy’s 10-year Delivering for America plan.” 
  • HHS posted a fact sheet on new government efforts to reduce the impact of spread of avian flu H5N1
  • Senators John Fetterman (D PA) and Tina Smith (D MN) announced a bill, “the United States Senate Commission on Mental Health Act of 2024. The bill would establish a U.S. Senate Commission on Mental Health tasked with providing Congress and the president independent, expert policy recommendations to improve access to and affordability of mental health care services. * * * Full text of the bill can be found here.“

From the public health and medical research front,

  • The Centers for Disease Control tells us today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare continues to decrease across most areas of the country. This week, no jurisdictions experienced moderate, high, or very high activity.
    • “Nationally, emergency department visits with diagnosed influenza are decreasing. Emergency department visits with COVID-19 and RSV remain stable at low levels.
    • “Nationally, influenza and RSV test positivity decreased compared to the previous week. COVID-19 test positivity remained stable at low levels.
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, is minimal.”
  • STAT News reports “Harvard scientists unveil the most detailed map of the brain ever: ‘It’s an alien world inside your own head’”.
    • “On Thursday, [Dr. Jeffrey’ Lichtman and his partners unveiled the results of their [decade long] efforts in the prestigious journal Science, and also posted to the internet renderings of the human brain unlike any ever seen. They came complete with a program that allows viewers to move through a microscopic alien landscape so detailed Lichtman can’t resist waxing poetic when he talks about it.
    • “It’s an alien world inside your own head,” he said. “Neurons themselves are truly awe inspiringly beautiful. There’s no two ways about it.”
    • “True, the insights gleaned from the tiny sample have not yet unraveled the mysteries of autism, schizophrenia, or depression. They can’t yet explain the mechanics of human learning, memory, and personality on the cellular level. But they represent an important first step in that direction, and provide a tantalizing preview of the kind of insights we might see in the decades ahead.”
  • The Wall Street Journal reports,
    • “Bristol Myers Squibb said on Friday that its trial evaluating a combination of cancer treatments failed to meet its primary endpoint.
    • “The company’s trial was evaluating the cancer-drug Opdivo and concurrent chemoradiotherapy, followed by Opdivo plus Yervoy, the brand name for a monoclonal antibody, in treating unresectable, locally advanced non-small cell lung cancer. The trial’s primary endpoint was progression-free survival.
    • “Bristol Myers Squibb said it would fully evaluate the data and work with investigators to share results with the scientific community.
    • “Opdivo and certain combinations with Opdivo are approved treatments for eligible patients with non-small cell lung cancer.”
  • Per Fierce Healthcare,
    • “Cancer diagnoses are on the rise among younger adults, and a new guidebook seeks to arm employers with the tools necessary to tackle this issue.
    • “The Northeast Business Group on Health’s new toolkit highlights actions employers can take to proactively address growing rates for five types of cancer in their workforce: breast cancer, colorectal cancer, head and neck cancer, cancer of the reproductive organs and skin cancer.
    • “There’s a clear business case for putting a focus on cancer, as the cost of therapies continues to increase and patients often require treatment for the long haul, NEBGH Medical Director Mark Cunningham-Hill, M.D., told Fierce Healthcare.
    • “He said that many employers, especially larger firms, have established sophisticated and comprehensive wellness and health programs for their workers. But they can do more to “connect the dots” between those offerings and critical preventive care around cancer and conditions that increase risk factors, like obesity.”
  • USA Data relates,
    • One out of every 42 babies born in the United States in 2021 was conceived using IVF or other assisted reproductive technologies.  
    • Parents who started treatments in 2021 gave birth to 97,128 babies, a 49% increase from 2012. In 2021, 238,126 patients initiated 413,776 IVF or similar treatment cycles, up 135% from 2012. 
    • IVF was most common in Washington, DC, with 5.8% of babies conceived via IVF, Massachusetts (5.4%), and New Jersey (5.0%). Less than one percent of infants born in Puerto Rico were conceived via IVF (0.4%). Alabama (0.6%) and Arkansas (0.7%) also had low rates.  

From the U.S. healthcare business front,

  • The Kaiser Family Foundation released a “KFF Health Tracking Poll May 2024: The Public’s Use and Views of GLP-1 Drugs.” Here are the key finding from the poll:
    • “The latest KFF Health Tracking Poll finds that about one in eight adults (12%) say they have ever taken a GLP-1 agonist – an increasingly popular class of prescription drugs used for weight loss and to treat diabetes or prevent heart attacks or strokes for adults with heart disease – including 6% who say they are currently taking such a drug. The share who report ever taking these drugs rises to four in ten (43%) among adults who have been told by a doctor that they have diabetes, a quarter who have been told they have heart disease, and one in five (22%) who have been told by a doctor that they are overweight or obese in the past five years1. Public awareness of GLP-1 drugs has increased in the past year, with about one-third (32%) of adults now saying they have heard “a lot” about these drugs, up from 19% in July 2023.
    • “Most adults who have taken GLP-1 drugs say they took them to treat a chronic condition including diabetes or heart disease (62%), while about four in ten say they took them primarily to lose weight.
    • “About half (54%) of all adults who have taken GLP-1 drugs say it was difficult to afford the cost, including one in five (22%) who say it was “very difficult.” While most insured adults who have taken these drugs say their insurance covered at least part of the cost, even among insured adults about half (53%) say the cost was difficult to afford2.
    • “While 8% of adults ages 65 and older say they have taken a GLP-1 medication for a chronic condition, just 1% say they have ever taken a GLP-1 drug to lose weight, which may reflect Medicare’s lack of coverage for prescription drugs used for weight loss. Nearly four in ten (37%) adults ages 65 and older report being told by a doctor they are overweight or obese in the past five years.
    • “With Medicare currently prohibited by law from covering prescription drugs used for weight loss, six in ten adults say they think Medicare should cover the cost of these drugs when prescribed for weight loss for people who are overweight, including more than half of Democrats, independents and Republicans. Similar shares of the public continue to support Medicare coverage of these drugs for weight loss even after hearing arguments for and against this proposal.”
  • Per BioPharma Dive,
    • “Sanofi will pay vaccine maker Novavax $500 million and take a small equity stake in the Maryland-based company as part of a broad COVID-19 shot alliance, the companies announced Friday.
    • “Through the deal, Sanofi will gain rights to co-market Novavax’s protein-based COVID vaccine globally, excepting certain countries, and a license to combine it with Sanofi’s existing influenza shots. Sanofi will also hold a non-exclusive right to use Novavax’s soap bark tree-derived adjuvant in other products it develops.
    • “Starting next year, Sanofi will book sales of Novavax’s COVID shot and pay Novavax double-digit percentage royalties. The French pharmaceutical company will also support certain R&D, regulatory and commercial expenses.”
  • Per MedTech Dive,
    • “Tandem Diabetes Care is recalling a version of its t:connect app for iPhone because of a fault that could drain insulin pump batteries, the Food and Drug Administration said Wednesday.”Tandem Diabetes Care is recalling a version of its t:connect app for iPhone because of a fault that could drain insulin pump batteries, the Food and Drug Administration said Wednesday.
    • “After updating the app in February, Tandem received 224 injury reports in about two months. The reports related to an issue that caused the app to crash and relaunch, resulting in excessive use of Bluetooth and potentially draining the battery of the connected insulin pump.
    • “The FDA categorized the event as a Class I recall because of the life-threatening potential for pumps to deliver too little insulin. Tandem corrected the fault in an app update in March.”
  • The Wall Street Journal explains why “Getting Alzheimer’s treatment to those who need it poses particular challenges.” For example
    • “The problem isn’t this drug. Sure. It has risks, et cetera,” said Jason Karlawish, co-director, of the Penn Memory Center at the University of Pennsylvania. “But the problem was the drug and the system — namely with a system of care for its delivery.”
    • “Karlawish said his memory center infused its first patient with Leqembi on November 16. He said that in the six months since, the number of patients who have received the drug there has climbed into the double-digits, reaching roughly 50 people. That, he said, required setting up an infrastructure that “either didn’t exist or existed in bits that had to be put together.”
  • MedCity new points out,
    • “Navigation challenges are the top reason consumers stop seeing healthcare providers, while experience issues are the main reason consumers leave their health insurer, a new survey found.
    • “The Accenture report, released last week, surveyed more than 9,700 insured consumers and 8,000 consumers who sought or received care in the prior year. The survey is a follow-up to a 2021 report, which examined why people are loyal or not loyal to their payer or provider.
    • “We wanted to leverage our patient and member experience surveys to continue to track the state of consumerism in health care, assessing how providers and health insurers perform across a number of key touchpoints that drive selection, loyalty, value and ease of use,” said Sarah Sinha, a managing director in Accenture’s health business, in an email.”
  • Insurance Business tells us,
    • “Offering support across a variety of functions including customer service, claims processing, underwriting, and fraud detection, the capability of AI to analyze large datasets and process information will continue to revolutionize insurance.
    • “Nirmal Ranganathan, vice president of engineering, AI, at Rackspace Technology, spoke with Insurance Business on how insurance companies can take advantage of AI to generate cost savings across their businesses.”
    • Check it out.

Monday Roundup

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

From Washington, DC,

  • Govexec reports
    • “Weeks following the news that Office of Personnel Management Director Kiran Ahuja would step down, agency Deputy Director Rob Shriver has been appointed acting director of the federal government’s dedicated HR agency.
    • “Shriver announced the news in a post on LinkedIn. * * *
    • “According to the Vacancies Act, Shriver may serve as acting OPM director for 210 days, or until Dec. 2. If he is ultimately nominated to succeed Ahuja on a permanent basis, he likely will be able to remain in the acting director role during the Senate confirmation process, thanks to his service as her “first assistant” in a Senate-confirmed position.”
  • Federal News Network tells us,
    • “Highlighting the work federal employees and other civil servants perform, and especially noting their efforts in administrating pandemic recovery programs, President Joe Biden expressed his appreciation for public servants across the country. In keeping with tradition, the White House issued a proclamation that May 5 will mark the beginning of Public Service Recognition Week.
    • “PSRW is traditionally celebrated the first full week of May. Many federally-focused organizations, including the National Active and Retired Federal Employees Association, show appreciation for public servants during the month of May.”
  • Govexec adds,
    • “Sammie Tafoya, a foreign service officer assigned to Haiti, said she didn’t know what the State Department was when her African history professor encouraged her to apply to work there. 
    • “Whenever I wrote for his class, he said…‘I think what you are looking for — the idea of being able to push change and to be able to write to inform the people that have power to make policies — there’s actually an agency for that. It’s the State Department. It’s the Foreign Service,’” she said. 
    • “Tafoya is one of 25 finalists announced Monday for the Partnership for Public Service’s 2024 Service to America Medals. Nicknamed the Sammies after the award’s namesake, Samuel J. Heyman, who founded the nonpartisan organization, the program has been around since 2002 and honors excellence and innovation in the career federal service. 
    • “The finalists will be recognized at a reception on Thursday, and winners will be announced ahead of an awards ceremony on Sept. 11 at the Kennedy Center.  * * *
    • “A full list can be found here.” 
  • The Society for Human Resource Management informs us,
    • “On May 3, President Joe Biden vetoed a resolution to overturn the National Labor Relations Board’s (NLRB’s) joint employer rule. However, the rule has been blocked by a federal district court in Texas, and litigation might continue.
    • “Overcoming the veto by a two-thirds majority vote in the Senate and House of Representatives is unlikely. The resolution passed the House by a 206-177 vote on Jan. 12 and cleared the Senate by a 50-48 vote on April 10. SHRM had urged Biden not to veto the measure.”

From the public health and medical research front,

  • The New York Time reports,
    • “Scientists are proposing a new way of understanding the genetics of Alzheimer’s that would mean that up to a fifth of patients would be considered to have a genetically caused form of the disease.
    • “Currently, the vast majority of Alzheimer’s cases do not have a clearly identified cause. The new designation, proposed in a studypublished Monday, could broaden the scope of efforts to develop treatments, including gene therapy, and affect the design of clinical trials.
    • “It could also mean that hundreds of thousands of people in the United States alone could, if they chose, receive a diagnosis of Alzheimer’s before developing any symptoms of cognitive decline, although there currently are no treatments for people at that stage.
    • “The new classification would make this type of Alzheimer’s one of the most common genetic disorders in the world, medical experts said.”
  • and
    • “A new study, published Saturday in The Journal of the American Medical Association, revealed growing disparities in child death rates across racial and ethnic groups. Black and Native American youths ages 1 to 19 died at significantly higher rates than white youths — predominantly from injuries such as car accidents, homicides and suicides.
    • “Dr. Coleen Cunningham, chair of pediatrics at the University of California, Irvine, and the pediatrician in chief at Children’s Hospital of Orange County, who was not involved in the study, said the detailed analysis of the disparities documented “a sad and growing American tragedy.”
    • “Almost all are preventable,” she said, “if we make it a priority.”
  • The Wall Street Journal discusses efforts in the U.S. to eliminate cervical cancer using the HPV vaccine.
    • “Doctors are rallying around an audacious goal: eliminating a cancer for the first time. 
    • “Cervical cancer rates in the U.S. have dropped by more than half since the 1970s. Pap tests enable doctors to purge precancerous cells, and a vaccine approved in 2006 has protected a generation of women against human papillomavirus, a sexually transmitted infection that causes more than 90% of cervical cancers. 
    • “With this evidence that the disease is preventable, groups that have worked for decades to end polio and malaria are turning to cervical cancer, plotting to take cases down to null. The World Health Organization is urging countries to boost vaccination, screening and treatment. Doctors in the U.S. are working on a national plan.” 
  • Beckers Hospital Review lets us know,
    • “A 12-year-old boy is the first commercial patient in the world to receive an FDA-approved gene therapy for sickle cell disease, The New York Times reported May 6.
    • “Kendric Cromer is a 12-year-old boy from the suburbs of Washington, D.C., and the first to receive Lyfgenia, a gene therapy treatment created by Somerville, Mass.-based Bluebird Bio. Kendric’s treatment, which costs about $3.1 million, is covered by his family’s insurance. He underwent the first part of treatment at Washington, D.C.-based Children’s National Hospital, in which physicians removed his bone marrow stem cells, which Bluebird will genetically modify for his treatment. The modified cells will be returned in three months.
    • “The FDA gave two companies authorization to sell gene therapy to people with sickle cell disease, a genetic disorder that affects roughly 100,000 people, most of them Black. 
    • “Bluebird estimates it can only treat 85 to 105 patients each year with sickle cell or beta thalassemia, who can receive a similar gene therapy. Children’s National, meanwhile, said it can accept only 10 gene therapy patients a year.”
  • The American Medical Association points out “What doctors wish patients knew about osteoporosis.”
  • The National Institute for Mental Health updated its website about coping with traumatic events.
  • The Washington Post notes, Ultrasound technology is used in many ways. Addiction is the next frontier. The use of the high-frequency sound waves is also being adapted to treat Alzheimer’s disease, tumors and psychiatric disorders.

From the U.S. healthcare business front,

  • Fierce Healthcare offers a look at how “major payers fared in a Q1 dragged by a cyberattack, MA challenges,” and Beckers Payer Issues ranks major payers by first quarter 2023 and 2024 medical loss ratios.
  • Beckers Payer Issues discusses major Medicare Advantage insurer plans for 2025.
  • Healthcare Dive reports,
    • “Dallas-based Steward Health Care, the largest physician-led hospital operator in the country, filed for Chapter 11 bankruptcy this morning in the U.S. Bankruptcy Court for the Southern District of Texas, following months of financial struggles including missed payments to its landlord and vendors.
    • “Steward operates more than 30 hospitals across eight states, according to a spokesperson for the company. The filing marks the largest provider bankruptcy in decades, according to Laura Coordes, professor of law at the Sandra Day O’Connor College of Law at Arizona State University.” 

Friday Factoids

David Ermer–CDC, CMS, Congress, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • A Senate Finance Committee tells us,
    • “U.S. Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and Chair Ron Wyden (D-Oregon) released a legislative proposal to address persistent economic problems leading to shortages of generic medicines plaguing America’s health care system, including chemotherapy drugs and ADHD medications. * * *
    • “The proposal, released as a discussion draft, would establish a new program in Medicare for hospitals and physicians to incentivize transparent, reliable, and resilient purchasing practices across supply-chain participants, including by driving health care providers, intermediaries (such as group purchasing organizations, or GPOs) and drug manufacturers to meet ambitious, proactive standards in securing a sustainable, high-quality supply of essential medicines for patients from all walks of life. * * *
    • “A one-page summary of the discussion draft can be found here.
    • “A section-by-section summary can be found here.
    • “The legislative text can be found here.”
  • STAT News reports,
    • “Members of Congress appear poised to advance another short-term [two year] extension of pandemic-era telehealth flexibilities instead of permanently addressing the issue, seven sources familiar with the talks said.
    • “During the Covid-19 pandemic, lawmakers allowed Medicare patients to access telehealth services in more places and with a greater variety of providers than before, but some of those flexibilities are set to expire at the end of the year. The expiration is expected to be an impetus for a broader health care package in December, when other public health programs also run out. * * *
    • “The House Ways & Means Committee is planning to mark up a two-year telehealth policy extension next week, per five sources familiar with the planning. Politico first reported the markup. According to two sources, the markup will contain entirely new language than is in the dozen or so bills that have been circulated so far.”
  • The U.S. Office of Personnel Management’s final Postal Service Health Benefits Program (PSHBP) implementation rule appeared in the Federal Register’s Public Inspection list today. The final rule will be published in the Federal Register on Monday May 6.
    • “OPM is making several changes between the interim final rule and this final rule:
      • “In § 890.1604, OPM is clarifying the requirements to enroll in Medicare Part B by expressly providing that the exceptions referring to events occurring “as ofJanuary 1, 2025” includes events that occur on January 1, 2025.”
      • In § 890.1604, OPM is clarifying the requirements to enroll in Medicare Part B by expressly providing that the exceptions referring to events occurring “as of January 1, 2025” includes events that occur on January 1, 2025.
      • “Section 890.1604(c) is reserved in anticipation of future rulemaking. [FEHBlog note — This provision creates exceptions from the Medicare Part B enrollment mandate for certain PSHBP enrollees and family members.]
      • “In § 890.1604(e), OPM is clarifying that a Postal Service annuitant or their family member who is required to be enrolled in Medicare Part B must promptly notify OPM or the Postal Service, in writing, if they choose not to enroll in or to disenroll from Medicare Part B.
      • “In § 890.1604, OPM is removing reference to the Postal Service as the entity to receive documentation of overseas residency to qualify for an exception to the Part B enrollment requirement.
      • “In § 890.1606(e), OPM is correcting a typographical error by removing the word “the” before “January 1 of the next year.”
  • A proposed follow-up PSHBP rule is pending review at OMB’s Office of Information and Regulatory Affairs. OPM further explains in the preamble.
    • “Topics OPM plans to address in more detail in the proposed rule include: reconsideration of initial decisions concerning PSHB eligibility; application of the Medicare Part B requirement and associated exceptions in specific scenarios; allocation of Reserves credits; calendar year alignment of government contribution requirements; financial reporting and actuarial calculations; premium payment prioritization from the Postal Service Retiree Health Benefits Fund; and Medicare Part D integration.” 
  • CMS also released a No Surprises Act user guide for resubmission of certain IDR cases.
    • “This user guide provides an overview of the “Notice of IDR Initiation – Resubmission” web form and the steps for successfully completing and submitting the web form. This user guide is intended to assist parties who have submitted a dispute through the Federal Independent Dispute Resolution (IDR) process and received an email from Auto-Reply-FederalIDRQuestions@cms.hhs.gov with a link to the “Notice of IDR Initiation – Resubmission” web form.
    • “The “Notice of IDR Initiation – Resubmission” web form will be sent to the initiating party if the certified IDR entity’s eligibility review of a dispute determines that one or more of the dispute line items must be resubmitted because it was improperly batched or bundled. The initiating party must complete the “Notice of IDR Initiation – Resubmission” web form by the deadline specified in the email. The non-initiating party will not need to take any action.”

From the public health and medical research front,

  • The Centers for Disease Control informs us on May 3:
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare continues to decrease across most areas of the country. This week, no jurisdictions experienced moderate, high, or very high activity. Last week one jurisdiction experienced moderate activity. No jurisdictions experienced high or very high activity.
    • “Nationally, emergency department visits with diagnosed influenza are decreasing. Emergency department visits with COVID-19 and RSV remain stable at low levels.
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week.
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, remains low.”
  • NBC News reports,
    • “New research suggests patients with an average risk of colon cancer may only need to undergo a colonoscopy screening every 15 years instead of the recommended 10. 
    • “Swedish researchers found that waiting an extra five years after a first negative colonoscopy carried about the same risk of later having a colorectal diagnosis or dying from the disease as getting screened every 10 years. Extending screening time could reduce “unnecessary invasive examinations,” according to the study published Thursday in JAMA Oncology.  * * *
    • “In an editorial accompanying the new study, gastroenterologists suggested that future screening guidelines may safely be prolonged for some people, noting that “15 has the potential to be the new 10.” * * *
    • “We do not have enough gastroenterology doctors to do a colonoscopy every 10 years in everyone over 50,” said Dr. Otis Brawley, the Bloomberg distinguished professor of oncology and epidemiology at Johns Hopkins University, who was not associated with the new research. * * *. 
    • “Employing cheaper, less invasive screening methods 10 to 15 years after a negative colonoscopy could greatly reduce the number of missed screenings, said the study’s lead author, Dr. Mahdi Fallah, head of the Risk Adapted Cancer Prevention Group at the German Cancer Research Center in Heidelberg. 
    • “The best screening test is the one that is actually done. So, if a test like colonoscopy is unaffordable for a person, an alternative cheaper valid test is much better than no test at all,” said Fallah, who is also a visiting professor in the department of clinical sciences at Lund University in Sweden.”
  • The Institute for Clinical and Economic Review announced on May 2,
    • “[We] will assess the comparative clinical effectiveness and value of tabelecleucel (“tab-cel”, Pierre Fabre) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).
    • “The assessment will be publicly discussed during a meeting of the New England CEPAC in November 2024, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.“

From the U.S. healthcare business front,

  • Kaufmann Hall announced on May 2,
    • “[Hospital m]argins and volumes declined slightly in March, which may signal more challenges ahead. Hospital outpatient revenue also fell 5%, reflecting the competitive challenges of providing outpatient care.
    • “The median Kaufman Hall Calendar Year-To-Date Operating Margin Index reflecting actual margins for the month of March was 3.9%.
    • “The April issue of the National Hospital Flash Report covers these and other key performance metrics.
  • and
    • “Overall labor expenses and revenue continue to rise, and Q1 2024 data show that labor represented 84% of total expenses. The median investment/subsidy per provider increased 2% compared to Q1 2023.
    • “The [Q1] Physician Flash Report features the most up-to-date industry trends drawn from the same data physician groups use to track their finances and operations.”
  • Beckers Hospital Review compares Spring 2024 Leapfrog Hospital Safety Grades against CMS Star ratings for hospitals receiving high and low Leapfrog grades.
  • BioPharma Dive notes,
    • “Amgen shares soared by double digits Friday following its announcement an obesity drug it’s developing has shown enough promise to warrant advancing into late-stage testing.
    • “On an earnings call with analysts Thursday, CEO Robert Bradway said the company is “confident” in the drug’s “differentiated profile” following an internal review of interim Phase 2 study results. Full data are expected by the end of the year and should support a subsequent move into Phase 3 trials, executives said.
    • “Yet Amgen’s drug is likely at least two years away from regulators’ desks, by which time Eli Lilly and Novo Nordisk may already have successors to their weight loss medicines Wegovy and Zepbound. It will take even more time to accumulate data to prove the drug can protect heart health, a key claim for convincing commercial and federal insurers to reimburse for treatment.”
  • Healthcare Dive lets us know,
    • “Walgreens has inked a clinical trial deal with major German drugmaker Boehringer Ingelheim.
    • “Under the deal, Walgreens will find candidates who are overweight or have obesity or diabetes and connect them with a Phase III clinical trial for Boehringer’s GLP-1 drug survodutide, according to a release.
    • “Walgreens launched its clinical trials business in 2022 as part of the company’s broader pivot to health services. Since then, Walgreens has notched more than 35 clinical trials deals with life sciences companies, according to a spokesperson.”

Tuesday Tidbits

David Ermer–ACA, CDC, Congress, FDA, Medical / Rx research, NCQA, NIH, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DCm

  • The Wall Street Journal reports,
    • “House Democratic leaders said they would block any effort to remove Speaker Mike Johnson (R., La.), moving to protect the Republican leader from retaliation by his hard-right flank following the passage of a sweeping foreign-aid package that included funding for Ukraine.”
  • This is a smart move because accord to what the FEHBlog has been reading, the Democrats are likely to retake the House of Representatives in the fall election.
  • The Journal also relates,
    • “The Federal Trade Commission is challenging hundreds of pharmaceutical patent listings in an effort to smooth the path to more affordable alternatives to brand-name drugs—including blockbusters such as Ozempic and Victoza.
      • “The crackdown is the latest assault against what the agency regards as drugmakers’ patent ploys intended to stall generic competition.
      • “At issue is what is called the Orange Book, a document published by the Food and Drug Administration that lists patents relevant to brand-name pharmaceuticals. Under a law meant to encourage generics, if a generics maker can successfully challenge listed patents, it can be granted a period of exclusivity before other generics are approved. But a challenge to an Orange Book patent, should a brand-name manufacturer decide to fight in court, also delays a generic’s approval for 30 months.
      • “The FTC says that drugmakers needlessly list oodles of extra patents in the Orange Book, delaying generic alternatives and artificially keeping prices high.”
  • HealthLeaders Media adds,
    • “Medicare Part D saved nearly $15 billion over six years with the use of “skinny label” generics, a new report says.
    • “However, the program is imperiled by a lawsuit claiming patent infringement, researchers at Brigham and Women’s Hospital and Harvard Medical School said in a research letter published on Monday in Annals of Internal Medicine.
    • “The researchers are urging Congress to “reinforce the skinny-label pathway by creating a safe harbor that protects manufacturers engaged in skinny labeling from induced patent infringement laws.”
    • “Skinny labels permit the use of generics for conditions that are not specified by brand-name drug makers and allow the cheaper generics to enter the market before the patent of the brand-name drug expires. 
  •  The U.S. Preventive Services Task Force finalized a breast cancer screening recommendation today.
    • The Task Force now recommends that all women get screened for breast cancer every other year starting at age 40 [previously age 50 for USPSTF purposes and 40 for Affordable Care Act purposes] and continuing through age 74. This is a B grade. More research is needed about whether and how additional screening might help women with dense breasts stay healthy and on the benefits and harms of screening in women older than 75. These are I statements.
  • The New York Times adds,
    • “In 2009, the task force raised the age for starting routine mammograms to 50 from 40, sparking wide controversy. At the time, researchers were concerned that earlier screening would do more harm than good, leading to unnecessary treatment in younger women, including alarming findings that lead to anxiety-producing procedures that are invasive but ultimately unnecessary.
    • “But now breast cancer rates among women in their 40s are on the rise, increasing by 2 percent a year between 2015 and 2019, said Dr. John Wong, vice chair of the task force. The panel continues to recommend screening every two years for women at average risk of breast cancer, though many patients and providers prefer annual screening. * * *
    • “Weighing in again on a hotly debated topic, the task force also said there was not enough evidence to endorse extra scans, such as ultrasounds or magnetic resonance imaging, for women with dense breast tissue.
    • “That means that insurers do not have to provide full coverage of additional screening for these women, whose cancers can be missed by mammograms alone and who are at higher risk for breast cancer to begin with. About half of all women aged 40 and older fall into this category.”
  • For Affordable Care Act preventive services coverage purposes, HHS’s Human Resources and Services Administration, not the USPSTF, is the final decision maker regarding the scope of women’s healthcare preventive services.

From the public health and medical research fronts,

  • STAT News lets us know today.
    • “Research is still being done to determine if all pasteurization techniques — there are multiple approaches — inactivate the [H5N1] virus. But the findings so far are reassuring. Scientists at St. Jude Children’s Hospital in Memphis, Tenn., have reported that while they could find genetic evidence of the virus in milk bought in stores, they could not grow live viruses from that milk, suggesting pasteurization kills H5N1. * * *
    • “But given the concentration of virus that researchers are seeing in milk from infected cows, they believe that raw milk — milk that has not been pasteurized — is an entirely different story.
    • “If cows that produce milk destined for the raw milk market got infected with H5N1, people who consume that milk could drink a large dose of the virus, scientists say. Thijs Kuiken, a pathologist in the department of viroscience at Erasmus Medical Center in Rotterdam, the Netherlands, said he’s heard of concentrations that would be the equivalent of a billion virus particles per milliliter of milk. He told STAT he thought authorities should ban raw milk sales while the outbreak is underway.”
  • The Washington Post reports,
    • “Postpartum depression is a leading cause of maternal death, but its diagnosis and treatment is spotty at best, negligent at worst.
    • “Now San Diego-based start-up Dionysus Digital Health is pitching a blood test to check for the condition, even before symptoms appear. The company says it has pinpointed a gene linking a person’s moods more closely to hormonal changes. The test uses machine learning to compare epigenetics — how genes are expressed — in your blood sample with benchmarks developed during a decade of research into pregnant people who did and didn’t develop postpartum depression.
    • “Researchers at Dionysus’s academic partners, the Royal’s Institute of Mental Health Research and UVA Health, have published peer-reviewedpapers affirming their findings, and the company is partnering with the Department of Defense and the National Institutes of Health for clinical trials, with the eventual goal of making the $250 test widely available and covered by insurance.” 
  • The National Institutes of Health announced,
    • “Sleep apnea and low oxygen levels while sleeping are associated with epilepsy that first occurs after 60 years of age, known as late-onset epilepsy, according to a new study funded by the National Institutes of Health (NIH) and published in Sleep. The link was independent of other known risk factors for late-onset epilepsy and sleep apnea including hypertension and stroke. The findings may help to better understand the relationship between sleep disorders and late-onset epilepsy, as well as identify potential targets for treatment.
    • “There’s increasing evidence that late-onset epilepsy may be indicative of underlying vascular disease, or neurodegenerative disease, even potentially as a preclinical marker of neurodegenerative disease,” said Rebecca Gottesman, M.D., Ph.D., chief of the Stroke Branch at the NIH’s National Institute of Neurological Disorders and Stroke (NINDS), and an author on the study. “Compared to other age groups, older adults have the highest incidence of new cases of epilepsy – up to half of which have no clear cause. Sleep apnea is common among people with epilepsy, but the association is not well understood.”
  • and
    • “Researchers have discovered that the smooth muscle cells that line the arteries of people with atherosclerosis can change into new cell types and develop traits similar to cancer that worsen the disease. Atherosclerosis is characterized by a narrowing of arterial walls and can increase risk of coronary artery disease, stroke, peripheral artery disease, or kidney disorders. The findings, supported by the National Institutes of Health (NIH), could pave the way for the use of anti-cancer drugs to counteract the tumor-like mechanisms driving the buildup of plaque in the arteries, the major cause of cardiovascular disease.
    • “This discovery opens up a whole new dimension for our understanding about therapeutic strategies for the prevention and treatment of atherosclerosis,” said Ahmed Hasan, M.D., Ph.D., program director in the Division of Cardiovascular Sciences at the National Heart, Lung, and Blood Institute, part of NIH. “Previous research has suggested that atherosclerosis and cancer may share some similarities, but this association has not been fully described until now.”
  • The Wall Street Journal tells us,
    • “An emerging field of research called chrononutrition indicates that choosing the right foods and meal times may improve our sleep. Some key findings: Eat dinner early. Keep consistent schedules. And, yes, drink milk.
    • You already know that fruits, veggies and lean protein are good for your health. But they can boost your sleep, too. These foods are the basis for the Mediterranean diet, which research shows may improve sleep quality, reduce sleep disturbances and boost sleep efficiency—the amount of time you spend asleep when you are in bed.” 

From the U.S. healthcare business front,

  • Healthcare Dive informs us,
    • “Walmart is closing its network of health clinics after failing to make them profitable, in a major setback for the retail giant’s push into healthcare.”Walmart is closing its network of health clinics after failing to make them profitable, in a major setback for the retail giant’s push into healthcare.
    • “Walmart Health launched as a one-store pilot in Georgia in 2019, and has since grown to 51 centers in five states, along with a virtual care offering. Yet the network has shown recent signs of trouble: Earlier this month, Walmart decelerated its expansion plans for the centers, which offer inexpensive, fixed-cost medical services like primary and dental care.
    • “Walmart is now closing the clinics entirely due to a challenging reimbursement environment and escalating operating costs resulting in a lack of profitability, according to a Tuesday press release. * * *
    • “In the end of Walmart Health illustrates that size alone is not a recipe for success in providing health services, according to Forrester’s Trzcinski. Walmart is the largest retailer in the U.S., with revenue of $648 billion in its most recent fiscal year.
    • “Despite building out the clinics, Walmart didn’t invest in driving adoption, including through digital health and customer experience, Trzcinski said. That caused it to fall behind other retailers that are surging ahead, such as Amazon and CVS.”
  • Per BioPharma Dive,
    • “Eli Lilly raised its revenue forecast for the year by $2 billion as sales of its GLP-1 medicines for diabetes and obesity continue to climb rapidly amid surging demand.
    • “The Indianapolis drugmaker currently can’t make its drugs Mounjaro and Zepbound fast enough, indicating in an earnings statement Tuesday that sales growth will “primarily be a function of the quantity the company can produce and ship.”
    • “Lilly is expanding manufacturing and expects greater capacity in the second half of the year. Revenue from Mounjaro, which is sold for diabetes, totaled $1.8 billion in the first quarter, while Zepbound revenue hit $517 million in its first full quarter on the U.S. market as an obesity treatment.”
  • and
    • “Lilly and Novo [Nordisk] aim to maintain their current hold on the market. Both companies are testing several experimental drugs with the goal of launching oral versions or even more effective treatments than their current products.
    • “Novo is already close to completing a Phase 3 trial program testing an oral form of Wegovy. It also has in late-stage development a combination of Wegovy with a compound called cagrilintide that acts on a gut hormone called amylin.
    • “Lilly has two drugs in Phase 3: an oral GLP-1 dubbed orforglipron that is approaching key data readouts next year and an injectable treatment called retatrutide that stimulates GLP-1, GIP and a third hormone known as glucagon. Results in obesity are due in 2026.
    • “Lilly has four experimental drugs in Phase 1 or 2, while Novo has five.
    • “[Lilly and Novo] cover all the bases,” said Clive Meanwell, CEO of Metsera, a newly launched startup that has two obesity drugs in clinical testing. “Our belief is it’s going to be a portfolio play, with mix and match, with different clinical circumstances and different markets.”
    • The article discusses similar projects from other companies.
  • Beckers Payer Issues reports,
    • “CMS and the NCQA are extending the quality data submission deadline for health plans by two weeks due to “extraordinary circumstances” caused by the cyberattack on Change Healthcare in late February.
    • “Payers will now have until 5pm Eastern Time on June 28 to report their performance on Healthcare Effectiveness Data and Information Set (HEDIS) measures to the two organizations, according to an April 29 memo from CMS. * * *
    • “The Change Healthcare cyberattack has created unprecedented challenges to healthcare organizations across the country,” Eric Schneider, MD, EVP, Quality Measurement and Research Group at NCQA, said in a statement to Becker’s. “This disruptive incident, falling in the middle of the substantial effort and commitment required for quality reporting efforts, has significantly strained resources. Recognizing these extraordinary circumstances and in alignment with CMS, we are granting a deadline extension for the submission of HEDIS Measurement Year 2023 results.”