Friday Factoids

Congress

Friday Factoids

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association (AHA) News tells us,
    • “Sens. Chuck Schumer, D-N.Y., Susan Collins, R-Maine, and Bob Casey, D-Pa., Sept. 11 introduced the SEPSIS Act, legislation which would task the Centers for Disease Control and Prevention with building on its current efforts addressing sepsis care. New efforts would include an education campaign about addressing sepsis in hospitals, improving pediatric sepsis data collection, sharing information with the Department of Health and Human Services on data collection, including the Centers for Medicare & Medicaid Services on sepsis quality measures, and the development and implementation of a sepsis outcome measure. The bill also includes a voluntary recognition program for hospitals which maintain effective sepsis programs or improve their programs over time.”  
  • The University of Minnesota’s CIDRAP lets us know,
    • “A National Academies of Sciences, Engineering and Medicine report recommends five actions to transition the National Wastewater Surveillance System (NWSS)—developed as a response to the COVID-19 pandemic—to a forward-looking version for both endemic and emerging pathogens.
    • “The paper, released yesterday, is the second and final report by the Academies’ Committee on Community Wastewater-Based Infectious Disease Surveillance done at the behest of the Centers for Disease Control and Prevention (CDC).
    • “The CDC launched the NWSS with the US Department of Health and Human Services to centralize the detection and quantification of pathogen biomarkers that people shed into the sewer system.
    • “Whereas clinical laboratory testing tracks individual cases of infection, sampling and analysis at the wastewater treatment plant level (termed community-level wastewater surveillance) provide aggregate data from the homes, businesses, and other institutions that share a common sewer system,” the committee wrote.”
  • CMS has launched a public facing website and posted a consumer fact sheet about the Medicare Prescription Payment Plan which will take effect January 1, 2025.
  • Healthline offers a projection of 2025 IRMAA brackets applicable to Medicare Parts B and D coverage for higher income beneficiaries.
  • Tammy Flanagan, writing in Govexec, offers thirteen things to know about long-term care planning.

From the public health and medical research front,

  • The Centers for Disease Control and Prevention posted their weekly summary concerning respiratory illnesses in the U.S. today.
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in most areas.
    • “COVID-19
      • “COVID-19 activity remains elevated nationally, but there are continued signs of decline in many areas. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+ and children under 2 years. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • RSV
      • “Nationally, RSV activity remains low.
    • Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines was low for children and adults for the 2023-24 respiratory illness season. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.”
  • Ruh roh. The New York Times reports,
    • “Someone who lived with a Missouri resident infected with bird flu also became ill on the same day, the Centers for Disease Control and Prevention reported on Friday.
    • “The disclosure raises the possibility that the virus, H5N1, spread from one person to another, experts said, in what would be the first known instance in the United States.
    • “On Friday night, C.D.C. officials said that there was “no epidemiological evidence at this time to support person-to-person transmission of H5N1,” but that additional research was needed.
    • “The coincidental timing of the illnesses, especially outside flu season, concerned independent experts. H5N1 has been known to spread between close contacts, including those living in the same household.
    • “And neither the initial patient nor the household contact had any known exposure to the virus via animals or raw milk.
    • “Neither patient has been identified, and details are scant. The household contact was not tested, so officials cannot be sure that the individual actually was infected with the bird flu virus.”
  • More ruh roh. Health Day points out,
    • “U.S. obesity rates keep rising, with 1 in every 5 people in every state reported to be obese in 2023
    • “In 23 states, 35% or more of the population is now obese
    • “Tackling unhealthy weight gain as early as childhood may be key to turning these numbers around.”
  • The NIH Director cheers us up by writing in her blog,
    • In Parkinson’s disease, neurons in parts of the brain gradually weaken and die, leading people to experience worsening problems with movement and other symptoms. While the causes of this disease aren’t fully known, studies have suggested the Parkinson’s brain lacks fuel to power dopamine-producing neurons that are essential for movement. When too many of those neurons are lost, Parkinson’s disease symptoms appear. But what if there was a way to boost energy levels in the brain and stop the neurodegenerative process in its tracks?
    • While the findings are preliminary, an NIH-supported study reported in Science Advances takes an encouraging step toward this goal. The key element, according to the new work, is an energy-producing enzyme known as phosphoglycerate kinase (PGK1). In fact, these latest preclinical findings in models of the disease suggest that boosting this enzyme in the brain even slightly may be enough to restore energy and afford some protection against Parkinson’s disease.
    • The team, led by Timothy Ryan and Alexandros Kokotos , Weill Cornell Medicine, New York City, was inspired by recent discoveries suggesting an unexpectedly important role for PGK1 in protecting the normal function of neurons. They knew PGK1 plays an essential role in the pathway through which cells use glucose to generate and store energy in the form of adenosine 5′-triphosphate (ATP) molecules. The surprise came when studies showed the drug terazosin, which is used to treat high blood pressure and enlarged prostate, has an unexpected side effect: it enhances PGK1 activity, although perhaps weakly. * * *
    • “For the approximately one million Americans with Parkinson’s disease today, current treatments help to relieve symptoms but don’t stop the disease from progressing. These new findings raise the possibility that terazosin or drugs that enhance PGK1 activity even more may fuel the brain, helping to protect essential dopamine-producing neurons to treat or even prevent Parkinson’s disease, as well as other neurodegenerative conditions where PGK1 may play a role.”
  • Per an NIH press release,
    • “The National Institutes of Health (NIH) has established a pandemic preparedness research network to conduct research on high-priority pathogens most likely to threaten human health with the goal of developing effective vaccines and monoclonal antibodies. Currently, many of the diseases caused by these pathogens have no available vaccines or therapeutics, and investing in this research is key to preparing for potential public health crises—both in the United States and around the world. NIH’s National Institute of Allergy and Infectious Diseases (NIAID) expects to commit approximately $100 million per year to fund the program, pending the availability of funds.
    • “The Research and Development of Vaccines and Monoclonal Antibodies for Pandemic Preparedness network—called ReVAMPP—will focus its research efforts on “prototype pathogens,” representative pathogens from virus families known to infect humans, and high-priority pathogens that have the potential to cause deadly diseases. By studying specific prototype pathogens, scientists will build a knowledge base that could be applied to other related viruses. For example, NIAID’s earlier work on the Middle East respiratory syndrome coronavirus (MERS-CoV) played a crucial role in understanding and developing safe and effective treatments and vaccines for SARS-CoV-2, the virus that caused the COVID-19 pandemic. The ReVAMPP network will study viruses from virus families that have caused human disease for millennia—many of which have the potential to become pandemic threats in the future.
    • “In the wake of the COVID-19 pandemic and ongoing outbreaks of emerging infectious diseases, the need for robust pandemic preparedness is evident,” said NIAID Director Jeanne M. Marrazzo, M.D., M.P.H. “The ReVAMPP network will enable researchers to fill key knowledge gaps and identify strategies to develop safe and effective medical countermeasures for targeted virus families before the need becomes critical.”
  • STAT News reports,
    • “A new drug — approved by regulators last month — has shown it can delay tumor progression, meaning patients could get more years to work and travel and be with their families before subjecting themselves to the rigors of the more pernicious treatments, which can lead to a range of health and cognitive problems. It is one of the first major brain tumor breakthroughs in decades.
    • “It gives you more time to do the things you love to do and lets you live a more normal life,” said [a patient], who enrolled in the trial that led to the approval of the drug, called Voranigo and developed by the privately held French firm Servier.
    • “Taken as a daily pill, Voranigo, or vorasidenib, is a signal to researchers and other pharmaceutical companies that success in this field is possible. It’s also the first targeted therapy designed specifically for this brain cancer, homing in on a genetic mutation that drives tumor formation and bringing the type of the success seen in lung and breast cancers to among the most difficult-to-treat tumors. 
    • “The drug, which has a list price of nearly $480,000 a year, is approved for patients with specific types of brain tumors — gliomas and astrocytomas — that are categorized as grade 2, a few thousand of which are diagnosed every year in the U.S. (Brain tumors are graded on a scale of 1 to 4, with higher grades indicating tumors that are more aggressive.) It’s also only meant for people who have particular mutations in one of two related genes, known as IDH1 or IDH2, who account for the large majority of low-grade glioma patients. Now, researchers are starting to test it in combination with other treatments in more advanced brain cancers. 
    • “I was in the field for 38 years, and when you can count the number of approved drugs on one hand, you know you’ve got a difficult disease to treat,” said Mark Gilbert, who recently retired as chief of the National Cancer Institute’s neuro-oncology branch.” 

From the U.S. healthcare business front,

  • The New York Times reports,
    • Boar’s Head announced on Friday that it would indefinitely shut down the troubled Virginia deli meat plant that it acknowledged had caused a deadly listeria outbreak, killing nine people and sickening dozens more in 18 states.
    • The company also said it had identified liverwurst processing as the source of contamination and would permanently discontinue the product.
    • “Given the seriousness of the outbreak, and the fact that it originated at Jarratt, we have made the difficult decision to indefinitely close this location,” the company said in a statement posted on its website Friday. The shutdown affects about 500 workers in Jarratt, Va., a small rural town whose economic livelihood largely depended on the plant’s business.
  • Per Fierce Healthcare,
    • “Employers are bracing for a third straight year with health benefit costs increasing more than 5%, according to a new report from Mercer.
    • “The organization released preliminary findings from its annual National Survey of Employer-Sponsored Health Plans and found that the total health benefit cost for individual employees is expected to increase by 5.8% in 2025. This accounts for any cost-reduction initiatives that employers may take on.
    • “The survey, based on responses from 1,800 employers across the country, estimates that with no cost-reduction efforts, expenses would increase by 7% per worker.”
  • and
    • “Elevance Health has entered into a deal to acquire Indiana University Health Plans, the company’s Anthem Blue Cross unit announced this week.
    • “Should the deal close, IU Health Plans will operate as part of Anthem in the Hoosier State, according to the press release. Financial terms of the sale were not disclosed.
    • “IU Health Plans provides Medicare Advantage plans to 19,000 people across 36 counties and has a 4.5-star rating from the Centers for Medicare & Medicaid Services. It also has 12,000 fully insured commercial plan members, according to the release.” * * *
    • “The parties expect the deal to close at the end of 2024.”
  • Per Beckers Hospital Review,
    • “Oakland, Calif.-based Kaiser Permanente received approval from the San Jose (Calif.) planning commission during a Sept. 11 meeting to move forward with plans to demolish its existing San Jose Medical Center and build a new hospital.
    • “Kaiser Permanente San Jose is excited about this new facility, which will provide greater access to high-quality care and medical services to our members and patients in the greater San Jose community,” a spokesperson for Kaiser shared with Becker’s in a Sept. 12 statement. 
    • “The project, which the health system shared initial plans for in February, would demolish the current 250,000-square-foot hospital and develop a new 685,000-square-foot hospital, central utility plant and a five-level parking garage, resulting in the addition of around 800 new employees.
    • “It would also increase bed count from 247 to 303, according to project highlights during the meeting.” 
  • Per Healthcare Dive,
    • “Steward Health Care exited a federal bankruptcy court hearing on Wednesday absolved of billions of dollars in outstanding lease agreements and with a plan to keep the majority of its remaining hospitals open.
    • “Under the deal, Steward’s landlord, Medical Properties Trust, will forgive approximately $7.5 billion in outstanding obligations and allow Steward to receive $395 million in proceeds from a recent hospital sale in Florida in order to pay its lenders and unsecured creditors, according to testimony from the health system’s chief restructuring advisor, John Castellano.
    • “In exchange, Steward will waive its rights to pursue lawsuits against the real estate investment trust.”
  • Per Fierce Pharma,
    • “When Roche’s Genentech gained approval for Ocrevus in 2017, the first-in-class infused drug quickly became the best-selling treatment in a crowded multiple sclerosis (MS) market. Three years later, Novartis’ next-in-class Kesimpta stole some of Ocrevus’ thunder, offering a convenience edge with its once-monthly, at-home prefilled injection. 
    • “Now, Genentech has responded with a new formulation as the FDA has endorsed a subcutaneous version of Ocrevus. While it can’t match the at-home convenience of Kesimpta, subcutaneous Ocrevus Zunovo, with its twice-a-year, under-the-skin dosing regimen, provides an attractive option.
    • “This is something than can be provided in clinics and doesn’t require people to go to an infusion center,” David Jones, Genentech’s medical director for MS, said in an interview. “This will expand access to individuals who may not be able to access Ocrevus now, especially for reasons like geography or rural setting, individuals that might have challenges with their healthcare provider.”
    • “Ocrevus Zunovo can be injected in 10 minutes, compared to the two-plus hours needed for an infusion of the drug. For patients who experience side effects, the intravenous infusion can take up to four hours.” 
  • and
    • “It’s better late than never for an FDA approval for the first subcutaneous PD-L1 inhibitor, which was doled out to Roche’s Tecentriq Hybreza after manufacturing delays derailed the company’s initial launch plans last year.
    • “The agency was originally slated to issue its verdict on Tecentriq in its under-the-skin formulation last September but the drug’s manufacturing processes needed updating, Roche’s delivery technology partner Halozyme Therapeutics said in a filing at the time. The tweaks, which a Roche spokesperson said were made in response to the FDA’s evolving requirements, were expected to wrap up in 2023 to support a 2024 launch. The world-first approval for the formulation came in the U.K. last year. 
    • “Now, the therapy has been cleared for use in the U.S. in all of the Tecentriq adult formulation’s indications, including types of lung, liver, skin and soft tissue cancers. The new version uses Halozyme’s Enhanze drug delivery tech to subcutaneously inject the product over seven minutes, compared to the 30 to 60 minutes needed for an IV infusion.
    • “By enabling subcutaneous administration for a cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration,” Roche’s chief medical officer and head of global product development Levi Garraway, M.D., Ph.D., said in a press release.”

Thursday Miscellany

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, OPM, Patient safety, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “Two U.S. senators are aiming to crack down on deceptive or misleading online promotion of weight-loss and other prescription drugs by telehealth firms and social-media influencers who profit from their posts.
    • “New bipartisan legislation proposed by Sens. Dick Durbin (D., Ill.) and Mike Braun (R., Ind.) would authorize the Food and Drug Administration to warn and potentially impose costly fines on those who post false information online about medicines or omit important information about a drug’s safety risks.
    • “One impetus for the bill, according to a Senate aide, is the 2024 reporting by The Wall Street Journal about how social media has fueled demand for Ozempic and Wegovy from Novo Nordisk as well as other drugs used for weight loss. The Journal found that posts on platforms such as TikTok, YouTube and Instagram often omit information about difficult side effects, and that some influencers and companies profit from the posts.”
  • Healthcare Dive informs us,
    • “Top executives at major pharmacy benefit managers are standing behind recent testimony on the Hill that put them in hot water with the chair of the powerful House Oversight Committee.
    • “Chair James Comer, R-Ky., accused Patrick Conway, the CEO of UnitedHealth’s Optum Rx; Adam Kautzner, the president of Cigna’s Express Scripts; and David Joyner, the president of CVS’ Caremark, of lying during a July hearing, and gave them until Wednesday to correct their statements or face potential fines or jail time.
    • “Optum Rx, Caremark and Express Scripts have responded to Comer and declined to change any testimony, the companies confirmed. The House Oversight Committee is “reviewing the PBMs’ written responses as well as the additional documents and information they provided,” according to a spokesperson.”
  • Per Fierce Healthcare,
    • “Steward Health Care CEO Ralph de la Torre, M.D., defied a subpoena to testify before Congress Thursday morning, leading heads of the investigating committee to promise civil enforcement and criminal charges for the executive.
    • “During the summer, the Senate Committee on Health, Education, Labor and Pensions (HELP) had voted to issue its first subpoena in over 40 years. Chairman Bernie Sanders, D-Vermont, said at the time that de la Torre needed to “explain to Congress the financial chicanery that made him extremely wealthy while the hospitals he managed went bankrupt.”
    • “Sanders and Committee Ranking Member Bill Cassidy, M.D., R-Louisiana, said Thursday that de la Torre’s legal team suggested he would be in attendance until they received a letter eight days ago. The letter informed the committee that he would not be attending out of concern that his testimony could harm the company’s ongoing bankruptcy proceedings. His legal counsel also suggested that the senators planned to turn their hearing into a “pseudo-criminal proceeding.”
    • “The committee overruled the letter a day later and told de la Torre to show up anyway. He did not.”
  • American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention Sept. 12 released a rural health strategic plan which includes the agency’s key priorities, objectives and outcomes in rural health for the next five years. The CDC’s priorities include advancing results-based engagement with partners and communities to address rural health challenges, strengthening rural health infrastructure and the workforce, advancing rural health science and improving rural health preparedness and response capacity. As part of the fiscal year 2023 Congressional appropriations, CDC created an Office of Rural Health to coordinate its growing rural health portfolio across the agency.”
  • Per HHS press releases,
    • “Today, the Department of Health and Human Services (HHS), through the Office of the Assistant Secretary for Health (OASH) and the Health Resources and Services Administration (HRSA), announce a Notice of Proposed Rulemaking (NPRM) to amend the regulations implementing the National Organ Transplant Act of 1984. * * *
    • “The proposed rule change, if finalized, would remove clinical research and institutional review board (IRB) requirements for transplantation of kidney and livers from donors with human immunodeficiency virus (HIV) to recipients with HIV. The proposed rule, Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act, is based on rigorous analysis of clinical data.
    • “If the proposed rule is finalized, HHS expects this rule will allow a larger number of transplant centers to conduct HOPE Act kidney and liver transplants and will help reduce the stigma and health disparities associated with HIV. 
    • “Public comments on the NPRM are due 30 days after publication of the NPRM in the Federal Register on October 15, 2024, at 11:59 PM ET. The NPRM may be viewed or downloaded at: Federal Register: Public Inspection: Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act.”
  • and
    • “Today, the U.S. Department of Health and Human Services, through the Office of Research Integrity (ORI), finalized the 2024 Public Health Service (PHS) Policies on Research Misconduct. This rule updates the 2005 regulation and clarifies requirements for addressing research misconduct in PHS-funded research.” * * *
    • “The research landscape has changed over the past 20 years with new technology, scientific advances, and globalization, which increases the need for ORI to remain nimble and collaborative. ORI is committed to keeping up with the needs of the research community,” said ORI Director Sheila Garrity. “The Final Rule aims to adapt to our current time, support our colleagues in the research community, and fortify ORI’s role in fostering research integrity and preserving public trust in science for future generations.”
    • “The Final Rule takes effect January 1, 2025, and becomes applicable on January 1, 2026. In the coming months, ORI plans to release sample policies and guidance to help prepare PHS-funded entities. The Final Rule can be found here https://www.federalregister.gov/public-inspection/2024-20814/public-health-service-policies-on-research-misconduct.”
  • FedWeek discusses the all-important Five-Year Rule which generally is a prerequisite for continuing FEHB and FEGLI coverage into federal retirement.

From the public health and medical research front,

  • STAT News reports,
    • “Disease investigators have not been able to determine how a person in Missouri with no known exposures to animals or poultry became infected with an H5 bird flu virus, the principal deputy director of the Centers for Disease Control and Prevention said Thursday.
    • “But Nirav Shah said the ongoing investigation has turned up no evidence of onward spread of the virus, suggesting this case may turn out to be a one-off infection that defies explanation.
    • “Here’s the bottom line: Our influenza surveillance system is designed to find needles in haystacks,” Shah said at a news briefing. “Here in this case, we found such a needle, but we don’t know how it got there. Our investigation continues, and we will keep everyone updated as we learn more.”
  • and
    • “Gilead said Thursday that its twice-yearly antiviral reduced the risk of HIV infections by 96% compared to an expected rate of infection in a second pivotal trial, paving the way for the likely approval of the drug for pre-exposure prophylaxis, or PrEP.
    • “The study, which enrolled cisgender men, transgender women, transgender men, and gender nonbinary individuals who have sex with partners assigned male at birth, also showed that the antiviral, called lenacapavir, was 89% more effective than a daily pill called Truvada.
    • “Specifically, two out of the 2,180 participants taking lenacapavir contracted HIV, while nine out of the 1,087 individuals in the Truvada group did.
  • The New York Times reports,
    • One dozen of 36 cinnamon products tested by a consumer group contained elevated levels of lead, according to a study released on Thursday that reinforced concerns about metals in foods after tainted cinnamon applesauce poisoned dozens of children last year.
    • The study, by Consumer Reports, documented levels that were far lower than the amounts discovered last year.
    • The Consumer Reports team tested the spice and found high levels in lead in 12 items sold at discount stores and ethnic markets, with lead levels reaching 3.5 parts per million. New York, the only state with tough lead standards in spices, recalls spices — among them curry powder, chili powder, cumin and five-spice powder — with more than one part per million of lead. Consumer Reports advised that people throw out items with that amount.
  • The American Hospital Association News lets us know,
    • “The AHA Sept. 12 released a new report that found hospital and health system performance on key patient safety and quality measures was better in the first quarter of 2024 than it was prior to the COVID-19 pandemic, and that hospitals made these improvements while caring for patients with more significant health care needs.  
    • “Hospitals and health systems are continuously working to advance patient safety and quality — which is always the hospital field’s top priority,” said AHA President and CEO Rick Pollack. “This report shows hospitals have made significant improvements on pre-pandemic performance in key patient safety outcomes. Hospitals’ commitment to improving patient outcomes and enhancing the patient experience continues to drive these efforts forward.”  
       
  • Beckers Hospital Review points out,
    • “Among 95 patients who are overweight or obese, an experimental daily pill from Novo Nordisk reduced their mean body weight by 13.1%, NBC News reported Sept. 10. 
    • “Novo Nordisk, the manufacturer of Ozempic, Wegovy, and other popular GLP-1 drugs, shared the phase 1 trial results at the European Association for the Study of Diabetes annual meeting. 
    • “The Denmark-based company recruited 124 patients and randomly assigned them either a placebo or its daily pill candidate, amycretin, to take for 12 weeks. Amycretin is a GLP-1 and protein-based unimolecular amylin, according to an abstract on the association’s website. 
    • “The trial’s primary endpoint was the number of treatment-emergent adverse events — which were found to be mild to moderate — and body weight changes were a key exploratory endpoint. The weight reduction results are “remarkable,” according to the abstract.
  • Per MedPage Today,
    • “The FDA warned that fezolinetant (Veozah), a hormone-free pill for moderate to severe hot flashes caused by menopause, could cause rare but serious liver injury.
    • “If women experience any signs or symptoms suggesting liver injury, they should stop fezolinetant, the agency said. Symptoms include new-onset fatigue, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or right upper quadrant pain.
    • “Treatment discontinuation may prevent worsening liver injury and may potentially return liver function to normal, the FDA explained.”
  • Per an NIH press release,
    • “National Institutes of Health (NIH) researchers and collaborators have found that being a carrier for sickle cell disease, known as having sickle cell trait, increases the risk of blood clots, a risk that is the same among diverse human populations that may not traditionally be associated with sickle cell disease. The study provides estimated clinical risks for people with sickle cell trait, which can inform clinical practice guidelines. Researchers examined the largest and most diverse set of people with sickle cell trait to date, which includes data from over 19,000 people of various ancestral backgrounds with sickle cell trait.  
    • The study, published in Blood Advances was led by researchers at National Human Genome Research Institute (NHGRI), part of NIH, The Johns Hopkins University School of Medicine, Baltimore, and the company 23andMe, South San Francisco, California.  * * *
    • “This study, therefore, provides important insights about patterns of venous blood clots and suggests a unique mechanism of blood clotting in people with sickle cell trait,” said Rakhi Naik, M.D., clinical director for the Division of Hematology at Johns Hopkins University, Baltimore, who co-led the study. “Knowing the risks of blood clots in people with sickle cell trait is important for situations such as surgeries or hospitalizations, which add to the risk of developing serious blood clots.” 
    • Over 2 million people in the United States have sickle cell trait. People with sickle cell trait have one copy of the genomic variant that causes sickle cell disease, a genetic condition that causes red blood cells to become rigid and sticky, which blocks blood flow. While people with sickle cell trait typically do not have any associated health complications, they are carriers for sickle cell disease. In rare cases, sickle cell trait has been found to be a risk factor for health complications such as muscle breakdown, presence of blood in the urine and kidney disease.  
  • Per Healio,
    • “Nearly one in 20 adults in the U.S. are estimated to have atrial fibrillation, many more than previous studies had indicated, according to new data out of the University of California, San Francisco.
    • “Atrial fibrillation doubles the risk of mortality, is one of the most common causes of stroke, increases risks of heart failure, myocardial infarction, chronic kidney disease and dementia, and results in lower quality of life,” Jean Jacques Noubiap, MD, PhD, postdoctoral scholar at University of California, San Francisco, said in a press release. “Fortunately, atrial fibrillation is preventable, and early detection and appropriate treatment can substantially reduce its adverse outcomes.”
  • The Institute for Clinical and Economic Review announced the release of a Draft Evidence Report on Treatment for Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease. The Public comment period now open until October 8, 2024; Requests to make oral comment during public meeting also being accepted.

From the U.S. healthcare business front,

  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones.
    • Once installed and customized to the user’s hearing needs, the Hearing Aid Feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.” 
  • McKinsey and Company explain why the U.S. physician shortage isn’t going anywhere.
  • STAT News reports,
    • “A new [medical debt relief model] pioneered in North Carolina shows how hospitals could make money off of a larger national program.
    • “In North Carolina, hospitals are set to collect billions in federal money to cancel patients’ medical debt and implement new policies to help prevent debt from accumulating in the first place. The funding comes as part of the state’s Medicaid expansion.
    • “Hospitals have significant political power to work federal programs to their advantage, and the template opens the door to other creative ways to use taxpayer funds to pay providers for medical debt. Read the full case study here.”
  • Beckers Payer Issues notes,
    • “Anthem Blue Cross Blue Shield is requesting payments from some providers it alleges falsified patients’ medical records when prescribing Ozempic, Bloomberg reported Sept. 12. 
    • “A spokesperson for Elevance Health, which owns Anthem BCBS, told Bloomberg it contacted a small number of providers about repayments for Ozempic prescribed to their patients. In some cases, the amount of repayment requested was more than $1 million. 
    • “Representatives for Elevance told Bloomberg that Anthem BCBS only covers Ozempic for patients with Type 2 diabetes. The drug is not approved by the FDA for weight loss, but is often prescribed off-label for that purpose.” 
  • Per Becker’s Hospital Review,
    • “A Wilmington, Del.-based physician has agreed to pay more than $1 million to settle allegations he violated the False Claims Act by ordering medically unnecessary durable medical equipment for Medicare and Federal Employees Health Benefits Program patients. 
    • “Vishal Patel, MD, referred patients for more than 1,750 orthotic devices between February 2018 and April 2019, according to a Sept. 11 Justice Department news release. The department alleged that Dr. Patel had no medical relationship with these patients and the referrals were based on brief reviews of their medical charts. 
    • “Medicare and the Federal Employees Health Benefits Program paid more than $400 on average for each device, according to the release. The patient files were provided to Dr. Patel by RediDoc, a telemedicine company whose owners pleaded guilty in 2022 to their roles in a $64 million fraud scheme. 
    • “The claims resolved by Dr. Patel’s settlement are only allegations and there has been no determination of liability, according to the release.”  

Midweek Update

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

From Washington, DC,

  • Roll Call reports,
    • “Speaker Mike Johnson’s plan to tie a six-month spending extension to a voting restriction bill pushed by former President Donald Trump was stymied Wednesday as the Louisiana Republican was forced to pull the package from the floor schedule.
    • “Johnson announced his decision midday in the face of certain defeat instead of pushing forward with the planned vote around 4:30 p.m. He said GOP leaders would continue to work on the package to try to shore up votes over the weekend, in hopes of bringing it back to the floor as soon as next week.
    • “The whip is going to do the hard work and build consensus. We’re going to work through the weekend on that,” Johnson told reporters shortly before the House convened at noon. “No vote today because we’re in the consensus-building business here in Congress. With small majorities, that’s what you do. …We’re having thoughtful conversations, family conversations, within the Republican conference, and I believe we’ll get there.”
    • “Despite vowing to push forward with the current text, the speaker and his allies will likely need to pivot to a new strategy to avoid a partial government shutdown at the end of the month — or wait and see if the Senate will take action to move its funding extension to mid-December.”
  • Per Healthcare Dive,
    • “More than 300 telehealth and provider organizations are urging Congress and the Biden administration to extend pandemic-era virtual prescribing flexibilities for controlled substances before they expire at the end of the year.
    • “In letters sent to Congressional leaders Tuesday, the groups asked lawmakers to pass a two-year extension of the flexibilities, which allowed clinicians to prescribe some controlled substances via telehealth without an in-person evaluation. The organizations, who want the extension included in an end-of-year legislative package, also pushed the White House to work with the Drug Enforcement Administration and other agencies to avoid an expiration of the telehealth prescribing changes.
    • “The groups argue the window for proposing a new rule is rapidly closing, and an extension would give regulators more time to figure out how to balance access to care and drug enforcement.”
  • Federal News Network discusses FEHB coverage of GLP-1 weight loss drugs.
  • Reg Jones, writing in FedWeek, explains the scope of retiree benefits for Benefits for those with less than a full federal career.
  • KFF posted “a new KFF analysis finds that federal spending on Medicare Advantage bonus payments will total at least $11.8 billion in 2024, a decrease of $1 billion from last year.” 

From the public health and medical research front,

  • NBC News reports,
    • “The number of pregnant women forced to travel farther to deliver their babies — or go without prenatal care entirely — is growing.
    • “A March of Dimes report published Tuesday found that over a third of U.S. counties (35.1%) are what the group calls “maternity care deserts,” meaning they don’t have a single doctor, nurse, midwife or medical center specializing in maternity care.
    • “More than 2.3 million women of childbearing age lived in one of these counties in 2022, when the data was collected for the new report, up from 2.2 million in 2020.
    • “The number of babies born in these counties also rose, from 146,000 to more than 150,000. 
    • “It’s getting worse over time,” said Ashley Stoneburner, lead report author and director of applied research and analytics at the March of Dimes.”  * * *
    • “States in which pregnant women had to travel the farthest to seek medical maternity care included Alaska, Hawaii and Montana.”
  • The New York Times informs us,
    • “About one in six adults — and about a quarter of adults younger than 30 — use chatbots to find medical advice and information at least once a month, according to a recent survey from KFF, a nonprofit health policy research organization.
    • “Supporters hope A.I. will empower patients by giving them more comprehensive medical explanations than a simple Google search might. “Google gives you access to information. A.I. gives access to clinical thought,” said Dave deBronkart, a patient advocate and blogger.
    • “Researchers know very little about how patients are using generative A.I. to answer their medical questions. Studies on this topic have been largely focused on hypothetical medical cases.
    • “Dr. Ateev Mehrotra, a public health researcher and professor at Brown University who studies patient uses for A.I. chatbots, said he doesn’t think experts have grasped just how many people were already using the technology to answer health questions.
    • “We’ve always thought that this is something coming down the pipe, but isn’t being used in big numbers right now,” he said. “I was quite struck by such a high rate” in the KFF survey.”
  • The National Cancer Institute posted its most recent cancer information highlights on the following topics: “Young Adults | Ancient Viruses | Cell Therapy.”
  • Per a National Institute of Health press release,
    • “Newborns who had an atypical pattern of metabolites were more than 14 times as likely to die of sudden infant death syndrome (SIDS), compared to infants who had more typical metabolic patterns, according to a study funded in part by the National Institutes of Health. Metabolites are molecules produced by the body’s various chemical reactions. Researchers found that infants who died of SIDS had a specific pattern of metabolites compared to infants who lived to their first year. The researchers believe that checking for this pattern could provide a way to identify infants at risk for SIDS. The study was conducted by Scott Oltman, M.S., of the University of California San Francisco School of Medicine, and colleagues. It appears in JAMA Pediatrics.
    • “SIDS is the sudden, unexplained death of an infant younger than 1 year of age that remains unexplained after a complete investigation.​ From more than 2 million infants born in California, researchers compared newborn screening test results of 354 SIDS cases to those of 1,416 infants who survived to at least one year old. The state screens all its newborns for many serious disorders. Test results include checking for metabolites that are markers for disorders and conditions. In the study, infants identified with the highest risk metabolic profile involving eight metabolites were 14.4 times more likely to have SIDS than infants with the lowest risk metabolic profile.
    • “The authors say that testing for metabolic patterns may provide a way to identify infants at risk for SIDS soon after birth, which could inform efforts to reduce SIDS risk. Similarly, research on the biochemical pathways that produce the metabolites linked to SIDS may yield insights into the causes of SIDS and ways to reduce its risk. NIH funding for the study was provided by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).”
  • Per Fierce Healthcare,
    • “Remote physiologic monitoring company Cadence released data showing that rural patients at Lifepoint Health clinics who took part in Cadence’s Type 2 diabetes and hypertension programs had better outcomes than their urban counterparts.
    • “The data are a result of the companies’ three-year partnership. Brentwood, Tennessee-based Lifepoint is deploying remote monitoring throughout its 60 community hospital campuses, more than 60 rehabilitation and behavioral health hospitals and more than 250 other sites of care. Together, they are serving 4,600 patients. About two-thirds of patients in the remote monitoring programs for diabetes and hypertension lived in rural or underserved areas.
    • “The data, released Wednesday by Cadence, show that 10% more patients achieved their target blood glucose level in rural areas than patients in urban areas—63% compared to 53%—and they achieved better blood glucose reduction.”
  • Per BioPharma Dive,
    • “Sanofi and Regeneron plan to make a second attempt at expanding use of their blockbuster drug Dupixent to people with a chronic skin condition that causes hives.
    • “The Food and Drug Administration rejected the companies’ initial application in chronic spontaneous urticaria, or CSU, last year, requesting additional efficacy data to support the new use. On Wednesday, Sanofi and Regeneron said they now have the results they need to try again and said they plan to submit a new application to the FDA by the end of the year.
    • “The trial, known as LIBERTY-CUPID Study C, enrolled patients with CSU who had uncontrolled symptoms and were taking antihistamines. Patients who added Dupixent to their treatment regimen had almost a 50% reduction in itch and urticaria activity scores, compared with those who received a placebo, Sanofi and Regeneron said.”

From the U.S. healthcare business front,

  • Beckers Hospital Review ranks 36 health systems by second quarter 2024 revenue.
  • ALM Benefits Pro tells us, “U.S. employer health plan medical spending has been rising more quickly for the plan enrollees who rank in the top 10% in terms of claims than for other enrollees, researchers report in a new paper published by the American Journal of Managed Care.”
  • Modern Healthcare reports,
    • “Aetna is leaning into technology it believes will alleviate patient and provider headaches from burdensome utilization management rules, Chief Medical Officer Dr. Cathy Moffitt said.
    • “To expedite care and reduce administrative obstacles, the health insurance company intends to automate about one-third of preapproval requests from providers this year, Moffitt, also a senior vice president at parent company CVS Health, said in an interview. But Aetna is walking a fine line as health insurers face backlash over how they incorporate technologies such as algorithms and artificial intelligence into the preapproval process.”
  • and
    • “Steward Health Care received approval from a U.S. Bankruptcy Court judge to sell three of its Florida hospitals to Orlando Health in a $439 million deal. 
    • “Orlando Health, the highest bidder for the facilities, is acquiring Melbourne Regional Medical Center, Rockledge Regional Medical Center and Sebastian River Medical Center, all in Florida, according to a Tuesday court filing.”
  • Per Fierce Healthcare,
    • “More Kaiser Permanente members in Colorado will soon be able to visit CommonSpirit Health hospitals for their inpatient and emergency care, the nonprofit giants announced Tuesday.
    • “Beginning “in early 2025,” Kaiser will integrate physicians and other employees into four Metro Denver area hospitals—St. Anthony Hospital in Lakewood, St. Anthony North Hospital in Westminster, Longmont United Hospital in Longmont and OrthoColorado Hospital (an orthopedic and spine specialty hospital) in Lakewood.
    • “Physicians who will be working at these centers under the strategic partnership will include hospitalists and surgeons alongside specialists such as cardiologists and pulmonologists, according to the announcement.”

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • BioPharma Dive reports
    • The U.S. House of Representatives voted Monday to approve legislation that would restrict U.S. companies from working with five China-based biotechnology firms on clinical development, research and manufacturing, in an attempt to secure the pharmaceutical supply chain.
    • The Biosecure Act passed 306-81 under a procedure used to pass relatively noncontroversial legislation. It was left out of a large Department of Defense bill that cleared the House in June, but may yet need to be included in a Senate version of that defense bill for it win support in that chamber.
    • The legislation would prohibit the federal government from contracting with the five “companies of concern” or any biotech that has a contract with those companies. Drugmakers with current contracts would have until 2032 to allow those deals to expire before being subject to the law.
  • Roll Call and Govexec bring us up to date on FY 2025 appropriations measures under consideration on Capitol Hill.
  • Govexec tells us,
    • “A bipartisan pair of lawmakers on Tuesday filed a discharge petition seeking to force a vote on the House floor on a measure that would eliminate a pair of controversial tax rules that reduce the retirement benefits of some ex-government workers.
    • “Reps. Abigail Spanberger, D-Va., and Garret Graves, R-La., are the lead sponsors of the Social Security Fairness Act (H.R. 82), a measure introduced last year that would eliminate Social Security’s windfall elimination provision and government pension offset.” * * *
    • “Though the bill has widespread support in Congress among both parties—with more than 300 cosponsors in the House alone—the chamber’s leadership has balked at allowing the bill to receive a floor vote. If Spanberger and Graves can secure at least 218 signatures among House lawmakers, they can then force such a vote to take place.”
  • FedWeek reminds us,
    • “September 30 is the end of the “special enrollment period” in which Postal Service retirees eligible for Medicare Part B but not currently enrolled in it may elect that coverage without the standard penalty for enrolling more than three months beyond first eligibility, which typically is on turning age 65.” * * *
    • “Further information on the special enrollment period is here.
    • “Meanwhile, the announcement of plans, coverage terms and premium rates in both the FEHB and the PSHB for 2025 is just ahead. That announcement commonly comes in late September or early October, with fuller information provided just ahead of the open season for enrolling or changing current enrollments, which this year will run November 11-December 9.”
  • Newfront poses a Q&A,
    • “Question: What steps do employers need to take to ensure their coverage meets the ACA affordability standard in 2025?
    • “Short Answer: The 2025 ACA affordability threshold increases to 9.02%. The easiest way to ensure affordability in 2025 is to meet the federal poverty line affordability safe harbor by offering at least one medical plan option (that provides minimum value) for which the monthly employee-share of the premium for employee-only coverage does not exceed $113.20. Otherwise, employers will need to calculate the applicable affordability threshold under one of the other safe harbor approaches, which are based on employee compensation levels.”
  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), recently awarded $68 million in grants for suicide prevention and mental health care programs. Addressing the U.S. mental health crisis and preventing suicide are top priorities of the Biden-Harris Administration and part of President Biden’s Unity Agenda.
    • “Every September we recognize Suicide Prevention Month as a time to raise awareness—to remind those struggling that they are not alone and that there is hope. Many people who have experienced suicidal thoughts are alive today because they got help,” said HHS Secretary Xavier Becerra, “The Biden-Harris Administration is deeply committed to expanding and improving suicide prevention in order to save lives. That is why we launched the 988 Suicide & Crisis Lifeline two years ago and why we continue to invest in suicide prevention programs that help save lives across this country.”
  • The Census Bureau posted its report with 2023 statistics on health insurance coverage in the United States based on information collected in the Current Population Survey Annual Social and Economic Supplement (CPS ASEC).
    • “Of the subtypes of health insurance coverage, employment-based insurance was the most common, covering 53.7 percent of the population for some or all of the calendar year, followed by Medicaid (18.9 percent), Medicare (18.9 percent), direct-purchase coverage (10.2 percent), TRICARE (2.6 percent), and VA and CHAMPVA coverage (1.0 percent).
    • “While the private coverage rate was statistically unchanged between 2022 and 2023, the employment-based coverage rate declined by 0.7 percentage points to 53.7 percent in 2023. At the same time, the rate of direct-purchase coverage increased by 0.3 percentage points to 10.2 percent in 2023.”

From the public health and medical research front,

  • Modern Healthcare reports,
    • “Cost, wait times, transportation problems and negative interactions with healthcare professionals are driving U.S. women to delay medical care or skip it altogether, according to a recent Deloitte survey.
    • “Half of the approximately 1,000 women who responded to the consultancy’s 2024 Health Care Consumer Survey said they had forgone care in the past year, compared with 37% of men, Deloitte said in a report Tuesday.
    • “Deloitte paired the results of its survey — which asked a representative sample of roughly 2,000 people in February 2024 about how everyone in the country could have quality medical care — with an analysis of claims data. It found that although women require on average almost 10% more health services than men, they’re about 35% more likely to say they’ve skipped or delayed care.”
  • JD Supra offers “5 Tips for Employers to Prepare for Cold, Flu, and COVID Season.”
  • The Centers for Disease Control and Prevention suggest five actions that communities can take to reduce suicides.
  • Per National Institutes of Health press releases,
    • “A scientific team supported by the National Institutes of Health (NIH) has created a preclinical blood test to identify adults most likely to develop severe respiratory conditions, including chronic obstructive pulmonary disease (COPD). The blood test analyzes 32 proteins that scientists determined accurately predicted an adult with an increased likelihood for requiring medical care for or dying from severe respiratory illness. The risk score was based on lung health data collected from nearly 2,500 U.S. adults over a 30-year period. The findings were published in the American Journal of Respiratory and Critical Care Medicine(link is external).
    • “We are still not ready for this test to be used in practice, but it’s a promising advance,” said James P. Kiley, Ph.D., director of the Division of Lung Diseases at NIH’s National Heart, Lung, and Blood Institute (NHLBI), which funded the study. “It consolidates insights from decades of breathing tests and medical evaluations into a single tool that has the potential to identify patients at risk for severe disease and complications.”
  • and
    • “Providing optional syphilis tests to most people seeking care at a large emergency department led to a dramatic increase in syphilis screening and diagnosis, according to a National Institutes of Health (NIH)-supported study of nearly 300,000 emergency department encounters in Chicago. Most people diagnosed had no symptoms, which suggests that symptom-based testing strategies alone could miss opportunities to diagnose and treat people with syphilis. The results were published today in the journal Open Forum Infectious Diseases.
    • “The Centers for Disease Control and Prevention (CDC) estimates that adult and congenital syphilis cases increased by 80% and 183% respectively between 2018 and 2022. Improved syphilis diagnosis strategies will be essential for reaching populations such as pregnant women and people with limited access to health care. The optimal model for syphilis screening has not been identified, particularly for preventing congenital syphilis. Previous literature supports targeted emergency department syphilis screenings based on clinical factors such as active symptoms or pregnancy. However, the screening criteria used in those models would not capture most people whose syphilis is asymptomatic.”
  • Here is a link to NIH’s Research Matters report covering “Deep brain stimulation for Parkinson’s | Brain-computer interface for speech | Glucose metabolism and Alzheimer’s disease.”
  • Per STAT News,
    • “The first late-stage trial of a GLP-1 drug in young children with obesity showed the treatment helped lower body mass index. But the findings also raise questions about whether obesity medications, some of which are currently approved for teenagers, should also be given to children at such a young age.”
  • Per Medscape
    • “Sustained participation in a community-based structured exercise program is linked to a reduced risk for all-cause hospitalization among older adults, but the benefits varied by gender {favoring women], according to a new study.”
  • Ruh roh. Bloomberg Prognosis lets us know,
    • “I [the reporter] was exposed to Covid at a family get-together in upstate New York last month. Two days later, I woke up feeling awful — sniffles, fatigue and fever. So I swabbed both nostrils with the last Covid test in our cabinet. 
    • “To my great surprise, it was negative, and I went back to sleep. When I tested again two days later, it turned positive in seconds. I started to wonder: Are home Covid tests bad at detecting the latest variants?
    • “The short answer is no, the doctors I spoke with told me. But that answer comes with a big caveat. It turns out the way the immune system interacts with the virus these days means home tests may not turn positive until several days after you get sick.”
  • More ruh roh. The New York Times reports,
    • “Two years before a deadly listeria outbreak [earlier this year], U.S. inspectors warned that conditions at a Boar’s Head plant posed an “imminent threat” to public health, citing extensive rust, deli meats exposed to wet ceilings, green mold and holes in the walls.
    • ‘But the U.S. Agriculture Department did not impose strict measures on the plant, in Jarratt, Va., which could have ranged from a warning letter to a suspension of operations.
    • “Since then, other inspections found that many of the problems persisted, but again, the plant continued to process tons of beef and pork products, including liverwurst.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “More providers are opting out of contracts with Medicare Advantage plans as national insurers reconfigure their networks, leaving patients in limbo.
    • “Medicare Advantage enrollment and profitability surged in recent years as a growing number of seniors sought plans with minimal copays and extra benefits not offered in traditional Medicare. However, Medicare Advantage enrollment growth has slowed and insurance companies’ earnings per member have declined over the past year as insurers grapple with stiffer competition, higher medical costs and utilization, lower reimbursement rates and stricter regulatory oversight.” * * *
    • “This is just the start of insurers’ squeeze on Medicare Advantage markets and provider contracts, the effects of which will grow as Medicare Advantage enrollment is expected to account for about 60% of all Medicare membership by 2030, consultants, analysts and policy experts said.
    • “This is the first year that MA plans have really hammered hospitals, and I think it will get uglier,” industry consultant Paul Keckley said.
    • “Health systems have walked away from in-network agreements or looked to scale up as a buffer and negotiating tool.”
  • and
    • “The American Medical Association released its updated list of Current Procedural Terminology codes for 2025, adding 270 new universal codes used for billing healthcare services and reimbursing providers.
    • “The organization announced 420 updates to its list Tuesday, with several revisions and additions for genetic testing, digital health services like remote patient monitoring and care involving artificial intelligence.”
  • Even more ruh roh. The American Hospital Association News complains,
    • “Hospitals and health systems are seeing significant increases in administrative costs, including due to burdensome practices by commercial insurers that often delay and deny care for patients, according to a new report released Sept. 10 by the AHA. 
    • “Many hospitals and health systems are forced to dedicate staff and clinical resources to appeal and overturn inappropriate denials, which alone can cost billions of dollars every year,” the report notes. 
    • “Among other findings, the report highlights recent data from Strata Decision Technology showing that administrative costs alone account for more than 40% of total expenses hospitals incur in delivering care to patients. In addition, between 2022 and 2023, care denials increased an average of 20.2% and 55.7% for commercial and Medicare Advantage claims, respectively.” 
  • Per Fierce Healthcare,
    • “UnitedHealth Group’s Optum Rx will join its peers in the big three pharmacy benefit managers by pulling Humira from some of its preferred formularies, according to a report from Reuters.
    • “Instead, it will recommend a cheaper biosimilar as the preferred option beginning Jan. 1, 2025, according to the article. Amgen’s Amjevita biosimilar will be among the options.
    • “CVS Health’s Caremark announced similar steps in April, and Cigna’s Express Scripts unit followed suit in August. Prescriptions for Sandoz’s Hyrimoz biosimilar spiked after CVS removed Humira from its major commercial formularies, according to a report in Stat.
    • “Reuters reported that UnitedHealth will continue to offer Humira coverage until the biosimilars are awarded an interchangeable designation from the Food and Drug Administration, which is expected in 2025.”

Monday Roundup

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

From Washington, DC,

  • Today, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury released a 500+ page long final rule significantly modifying the regulations governing the federal mental health and substance use disorder parity rule.
  • The agencies explain that the rule generally becomes applicable to health plans and issuers on the first day of the plan year beginning next year. The rule also specifies exceptions as to which the applicability date falls in 2026, but trust the FEHBlog, it’s hard to figure out what takes effect next year.
  • The Labor Department is holding an introductory webinar on September 19, 2024, at 2 pm ET. You can register at this link.
  • “AHIP, the Association of Behavioral Health and Wellness (ABHW), the Blue Cross Blue Shield Association (BCBSA), and The ERISA Industry Committee (ERIC) react to the Tri-Departments’ final mental health and substance use disorder parity rule released today.”
    • “The final Mental Health Parity and Addiction Equity Act (MHPAEA) rule will have severe unintended consequences that will raise costs and jeopardize patients’ access to safe, effective, and medically necessary mental health support. With nearly 50 million Americans experiencing a mental illness, there’s no question that addressing the shortage of mental health providers must be a top priority. There are proven solutions to increase access to mental health and substance use disorder care, including more effectively connecting patients to available providers, expanding telehealth resources and improving training for primary care providers. However, this rule promotes none of these solutions. Instead of expanding the workforce or meaningfully improving access to mental health support, the final rule will complicate compliance so much that it will be impossible to operationalize, resulting in worse patient outcomes.” 
    • “The organizations support the intent of mental health parity and are committed to strengthening compliance. We recognize that the Tri-Departments made changes to the proposed rule in response to public comments. However, this rule goes beyond the intent of the 2008 Mental Health Parity law, and we are concerned that it will negatively impact health outcomes, quality, and, ultimately, the cost of care.”
  • The FEHBlog heartily agrees with these organizations.
  • Fierce Healthcare adds,
    • “As ERIC evaluates this rule and assesses the implications for its member companies, we will consider all possibilities to prevent further harm to employer offering behavioral health benefits, and the employees and families who count on them—up to and including litigation,” said Mellissa Bartlett, senior vice president of health policy for ERIC.”
  • The American Hospital Association (AHA) News points out,
    • “The AHA Sept. 9 urged the Centers for Medicare & Medicaid Services to work with Congress on providing a pay increase for physicians in 2025 and develop a long-term plan for sustainable physician payment. AHA expressed its concerns to CMS while commenting on the agency’s calendar year 2025 physician fee schedule proposed rule, in which the proposed payment update would reduce payments approximately 2.8% from CY 2024 levels.”
  • Healio adds,
    • “A letter from AMA’s executive vice president called for CMS to be “fully transparent” on the impact that payment cuts in the 2025 Physician Fee Schedule will have on patients and physicians. * * *
    • “[This] proposed rule is silent on the impact of the growing gap between what Medicare pays for care and what it costs to provide that care,” the letter said. “A chorus of authorities on the Medicare program has expressed concern about the ability of patients to continue receiving high-quality care as physician payments erode.”
    • “Physician payments have declined by 29% from 2001 to 2024, the release noted.”
  • The AHA News further notes,
    • “A [federal] district court in Baltimore Sept. 5 ruled against drug companies and PhRMA, denying their attempt to obtain a preliminary injunction against 340B pricing for contract pharmacy arrangements in Maryland, according to Reuters. The AHA filed amicus briefs defending Maryland’s law against this drug industry challenge July 29 and Aug. 2, in addition to similar briefs filed in Missouri Aug. 29 and West Virginia Aug. 16.”
       
  • Govexec announces the 2024 winners of the ‘Oscars’ of government service. Kudos to them.

From the public health and medical research front,

  • Per Health Day,
    • “An epidemic of high blood pressure is occurring in young adults and children in the United States, a pair of new studies show.
    • “Nearly a quarter of people ages 18 to 39 have high blood pressure, with readings above the healthy level of 130/80, the first study found.
    • “Blood pressure is even a problem for school-age children, according to the second study. Nearly 14% of children ages 8 to 19 have elevated or high blood pressure, researchers found.
    • ‘Both studies were presented Friday at the American Heart Association (AHA) scientific sessions in Chicago. Such research should be considered preliminary until published in a peer-reviewed journal.
    • “The prevalence of hypertension in young adults is stark, and social determinants of health amplify the risk for hypertension and subsequent premature cardiovascular disease,” said Dr. Bonita Falkner, chair of the writing committee for the AHA’s 2023 scientific statement on pediatric hypertension.”
  • Consumer Reports writing in The Washington Post informs us,
    • “If you spot a blacklegged tick crawling up your leg — or worse, attached to your skin — you might be worried about getting Lyme disease. That’s reasonable because Lyme is the most commonly reported illness spread by ticks. But it is far from the only one: The blacklegged ticks that carry Lyme can spread at least six different illnesses.
    • “The tick-borne illness babesiosis is one of the next most common after Lyme. And it is on the rise, especially in the Northeast, according to a 2023 report by the Centers for Disease Control and Prevention.
    • “Babesiosis is less common than Lyme disease but tracks in the same areas,” said Paul Auwaerter, a professor of medicine and clinical director of the division of infectious diseases at the Johns Hopkins University School of Medicine in Baltimore. And it’s worth knowing about because it can be serious, especially for people who are immunocompromised, he said.”
  • The Wall Street Journal warns that American men are eating too much meat for their own good.
  • The Food and Drug Administration has created a website that discusses how much caffeine is too much.
  • STAT News reports,
    • “Relay Therapeutics disclosed encouraging results for its key breast cancer drug and plans to advance the experimental treatment, called RLY-2608, to a late-stage clinical trial, the biotech firm said on Monday.” * * *
    • “The new data come from an open label phase 1/2 trial on RLY-2608 combined with fulvestrant, an endocrine therapy for breast cancer, showing a third of patients with measurable disease responded to the treatment. The data were put out in a press release from Cambridge, Mass.-based Relay, and haven’t been published in a peer reviewed journal.
    • “RLY-2608 works on cancers that carry mutations in a gene called PIK3CA, which encodes a piece of the PI3K-alpha protein. This molecular pathway helps to control cell growth and division, and errors in it can drive a variety of cancers including breast cancer. It’s one of the most common mutations driving cancers and is implicated in 20% to 40% of breast cancer cases. 
    • “There are two approved drugs targeting this pathway, alpelisib or Piqray from Novartis and capivasertib or Truqap from AstraZeneca. Relay hopes its treatment will have an advantage over the existing therapies through improved efficacy or less toxicity.”
  • Per BioPharma Dive,
    • “An experimental weight loss pill developed by biotechnology company Terns Pharmaceuticals helped some people with obesity lose more than 5% of their body weight in a small Phase 1 trial, supporting plans to move the drug into mid-stage testing next year, the company said Monday.
    • “Trial volunteers who received the highest tested dose of Terns’ drug lost nearly 5 percentage points more weight than those who received a placebo over 28 days, the company said. Two-thirds lost over 5% of their body weight, suggesting the effects could be more substantial if the drug were to be taken over a longer period of time.
    • “The trial results indicate Terns could become a competitor in the race to develop pills for obesity. Injectable drug from Novo Nordisk and Eli Lilly currently dominate the market, but they and others, among them Pfizer and Roche, are vying to develop oral alternatives.”

From the U.S. healthcare business front,

  • Fierce Healthcare announced for the second year its Fierce 50 composed of “the people and companies who are driving meaningful change in healthcare, pharma and biotech.” Kudos to them.
  • STAT News reports,
    • “Apple on Monday announced a new Apple Watch feature that will warn users they may have sleep apnea. It’s the latest advance in the company’s decade-long effort to sell its wearable as a tool that can help people live healthier lives.
    • “Additionally, the company announced more hearing health features for its wireless earbuds. The company’s AirPods will be able to conduct a hearing test and later this fall will be able to be used as a “clinical grade over-the-counter hearing aid,” Apple’s vice president of health Sumbul Desai said in a prerecorded announcement video.” * * *
    • “Christine Lemke, the CEO of consumer health data company Evidation Health, said that a wearable’s sensors are probably best suited to screening rather than definitive diagnosis. 
    • “Still, she said, “It’s impactful to receive a proactive alert to explore this more with your physician. This seems like a moment in time where the sensors are good enough to provide valuable information for pre-screening purposes.”
  • Per Fierce Healthcare,
    • “Labor costs and availability were major pain points for hospital and health system operations during the pandemic but finally look to be leveling out even as demand for care services remains high, Fitch Ratings wrote in a recent report.
    • “Wage growth among hospitals had spiked in late 2021 and through much of 2022, when year-over-year average hourly earnings hovered at or above 8%, per U.S. Bureau of Labor Statistics cited in the agency’s report.
    • “During that time, hospitals had ramped up their salary offerings “to reverse persistently high turnover and external contract labor use,” Fitch wrote in its report.
    • ‘From January through July of this year, that same metric has now fallen to an average of about 3%, which is also above the 4.2% average of 2023.”

Weekend update

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

From Washington, DC

  • The Wall Street Journal observes,
    • “Mike Johnson’s tightrope walk to remain House speaker starts this coming week.
    • “The Louisiana Republican needs to pass a short-term spending bill to keep the government funded, avoid sparking open GOP rebellion, keep the Republican majority in the November election and then get colleagues to line up behind him in January. It is a tall order even for Johnson, who defied expectations by navigating the House through a series of sticky intraparty battles after stepping into the role of speaker when Kevin McCarthy was ousted last year.
    • “Right now, I’m solely focused on finishing the legislative session strong and protecting and growing our majority,” Johnson said in an interview, adding that he was preparing a “very aggressive” first 100 days of the next Congress. “When time comes to run for speaker, I intend to run, and I expect that I’ll be leading again.”

From the public health and medical research front,

  • STAT News reports,
    • “For years, Merck’s drug Keytruda has dominated cancer immunotherapy, racking up dozens of approvals, extending the lives of patients, and bringing in billions of dollars to the pharma giant. But detailed data presented by Summit Therapeutics on Sunday demonstrated that the company’s experimental therapy has done what no other has done before: beat Keytruda in a head-to-head late-stage trial in lung cancer.
    • “The Summit drug, an antibody called ivonescimab, reduced the risk of tumor progression by 49% compared to Keytruda, according to data released here at the World Conference on Lung Cancer. At the median, patients treated with ivonescimab went 11.1 months before their tumors began to grow again compared to 5.8 months for patients on Keytruda.”  * * *
    • “The Phase 3 study, called HARMONi-2, was conducted by Akeso, a Chinese company that invented ivonescimab and licensed it to Summit. Researchers enrolled nearly 400 patients with previously untreated, advanced non-small cell lung cancer. 
    • “Summit doesn’t plan to use the trial, conducted exclusively in China, to file for U.S. approval given the Food and Drug Administration’s wariness of such studies. But the biotech said in a press release Sunday that, based on the results, it plans to start a global trial early next year dubbed HARMONi-7 that will compare Keytruda and ivonescimab in patients with metastatic non-small cell lung cancer who have high levels of PD-L1.”
  • The Washington Post seeks to explain “how bird flu spreads, milk and egg safety and more.”
    • “Each time there is highly pathogenic avian influenza outbreak, it triggers concerns that the virus could mutate to infect humans more readily and start spreading from person to person.
    • T”hat happened with swine flu in 2009, when pigs became simultaneously infected with avian influenza and human influenza. The two viruses exchanged their genetic material inside the pigs, allowing the bird flu to use the genetic blueprint from the human flu to spread among people.
    • “Such a pandemic cannot be predicted because this exchange of genetic material is a random event.
    • “If anything, the odds are against it,” Schaffner said, noting that bird flu strains are circulating all the time and do not pose a risk to humans. Although the strain has infected some mammals — including mink, causing an outbreak at a Spanish farm in October 2022 — “that doesn’t necessarily mean it’s going to pick up the capacity to spread to humans,” he said.
  • The Washington Post also points out,
    • Only 61 percent of U.S. 13-to-17-year-olds have been fully vaccinated against the human papillomavirus (HPV), according to research published last month by the Centers for Disease Control and Prevention. The finding was based on vaccination records of over 16,500 adolescents obtained via the 2023 National Immunization Survey-Teen. The goal was to determine rates for the four routine adolescent vaccines: for tetanus-diphtheria-pertussis (Tdap), meningitis (MenACWY), HPV and the flu.” * * *
    • “Since the HPV vaccine has been in use in the United States, HPV infections and cervical pre-cancers have significantly dropped, said Cassandra Pingali, the study’s lead author. In the 2023 vaccination survey, about 77 percent of adolescents had received at least one dose of the HPV vaccine, while only 61 percent had completed the vaccination series. Though HPV vaccination numbers steadily increased until 2022, coverage has stalled for the second consecutive year.
    • “Of the surveyed adolescent vaccinations, HPV lags behind other routine shots. Research from the American Academy of Pediatrics suggests that many parents of adolescents are hesitant to vaccinate because of a lack of knowledge, fears about safety or their child not being sexually active.”
  • The New York Times asks us to
    • “welcome a new metric: the body roundness index. B.R.I. is just what it sounds like — a measure of how round or circlelike you are, using a formula that takes into account height and waist, but not weight.
    • “It’s a formula that may provide a better estimate of central obesity and abdominal fat, which are closely linked to an increased risk of developing Type 2 diabetes, hypertension and heart disease, unlike fat stored on the buttocks and thighs.
    • “A paper published in JAMA Network Open in June was the latest in a string of studies to report that B.R.I. is a promising predictor of mortality. B.R.I. scores generally run from 1 to 15; most people rank between 1 and 10. Among a nationally representative sample of 33,000 Americans, B.R.I. scores rose between 1999 and 2018, the new study found.
    • “Those with B.R.I. scores of 6.9 and up — indicating the roundest bodies — were at the highest risk of dying from cancer, heart disease and other illnesses.
    • “Their overall mortality risk was almost 50 percent greater than those with B.R.I.s of 4.5 to 5.5, which were in the midrange of the sample, while those with B.R.I. scores of 5.46 to 6.9 faced a risk that was 25 percent higher than those in the midrange.
    • “But those who were least round were also at elevated risk of death: People with B.R.I. scores under 3.41 also faced a mortality risk that was 25 percent higher than those in the midrange, the study found.
    • “The paper’s authors suggested the lower scores, seen mostly in those 65 and older, might have reflected malnutrition, muscle atrophy or inactivity.”

Friday Factoids

David Ermer–CDC, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Obesity, U.S. Healthcare–

From Washington, DC,

  • Federal News Network tells us,
    • “House Republicans are leading a supplemental funding bill to address a multi-billion-dollar budget crunch at the Department of Veterans Affairs.
    • “Leaders of the House Appropriations and House VA committees introduced a bill Friday that would give the VA $3 billion to ensure the department can keep paying benefits to veterans for the rest of the fiscal year.
    • “The Veterans Benefits Continuity and Accountability Supplemental Appropriations Act would ensure the VA has enough funding to keep paying veterans’ compensation, pension and readjustment benefits for the rest of fiscal 2024.
    • “The emergency funding bill, however, does not address a $12 billion shortfall the VA anticipates for fiscal 2025.” * * *
    • “The supplemental spending bill would require the VA to give Congress regular updates on the status of funds needed to pay veterans’ benefits until the end of fiscal 2026.
    • “The bill would also require the VA’s inspector general office to issue a report on the root causes of the VA’s budget shortfall.”
  • Per an FDA press release,
    • “Today, the FDA issued a draft guidance “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle”. This guidance, when finalized, is intended to provide recommendations on how patient preference information might be collected and shared with the FDA and potentially be considered in FDA decision-making processes. It also provides recommendations on designing patient preference studies that may provide reliable scientific evidence. On Oct. 15, 2024, the FDA will host a webinar for industry and other parties interested in learning more about the draft guidance. Please submit comments under docket number FDA-2015-D-1580 at www.regulations.gov by Dec. 5, 2024, to ensure the FDA considers comments before it begins work on the final version of the guidance.”
  • Healthcare Dive lets us know,
    • “The Federal Trade Commission is urging Indiana to block a hospital merger that antitrust regulators say will raise costs and lead to worse outcomes for patients.
    • “On Thursday, the FTC submitted a comment with the Indiana Department of Health asking it to oppose the combination of Union Hospital and Terre Haute Regional Hospital on the state’s western border — two hospitals that proposed their merger under a controversial certificate that opponents say allows problematic mergers to pass regulatory review.
    • “Union’s proposed acquisition of Terre Haute Regional — a facility owned by mammoth for-profit hospital operator HCA Healthcare — will likely increase hospital costs while negatively impacting healthcare services in Indiana, the FTC argued in its letter. It could also depress wages for registered nurses in the state.”
  • The American Journal of Managed Care informs us,
    • “The trend of food insecurity persists in the United States, with food insecurity, food expenditures, and need of assistance all reported in the country throughout 2023, according to a a new report from the US Department of Agriculture (USDA).
    • “The USDA defines food insecurity as either have a reduced quality, variety, or desirability of diet or having multiple indications of disrupted eating patterns and reduced food intake. Food insecurity is different than hunger according to the USDA, as hunger is a physiological condition that comes as a result of food insecurity whereas food insecurity itself is an economic and social condition that indicates uncertain or limited access to food.
    • “The new report found that 13.5% of households in the US were food insecure, totaling approximately 18 million households. Food insecurity in this context was defined as households who had difficulty providing enough food for their residents at some point during the year. The percentage increased from 2022 when it was 12.8%, from 2021 when it was 10.2%, and 2020 when it was 10.5%.1Low food security was reported in 5.1% of households in the country, which wasn’t different from the 2022 number but an increase from 3.8% reported in 2021. This food insecurity led to disrupted eating patterns through the year.
    • “A total of 8.9% of households with children were food insecure, which is similar to the 8.8% reported in 2022 but higher than the 6.2% reported in 2021. A total of 1.0% of households reported children experiencing very low food security, which is similar to the 1.0% reported in 2022 and 0.7% reported in 2021. Skipping a meal, not eating for a whole day due to lack of resources, and children being hungry was common in these households.”
  • Tammy Flanagan, writing in Govexec, discusses how to prepare for retirement as a federal employee.

From the public health and medical research front,

  • STAT News reports,
    • “A person in Missouri who didn’t report any contact with animals has tested positive for H5 bird flu, the state’s Department of Health and Senior Services and the Centers for Disease Control and Prevention said Friday. It’s not yet clear if the person was infected with the same virus strain that’s causing the ongoing outbreak among dairy cattle.
    • “The individual, who had been hospitalized on Aug. 22, had a number of underlying health issues. The person has since recovered and has been released, the state said in its statement.
    • “The CDC said this is the first case of H5 bird flu detected through the country’s national flu surveillance system, and the first H5 case in an individual without occupational exposure to infected cows or poultry.
    • “While news of an H5 infection in a person without known exposures to infected animals is unsettling, experts who spoke with STAT cautioned that it is too early to jump to any conclusions.”
  • The Centers for Disease Control and Prevention issued its weekly summary on respiratory illnesses in the U.S.
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in most areas.
    • “COVID-19
      • “COVID-19 activity remains elevated nationally, but there are continued signs of decline in many areas. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+ and children under 2 years. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • ‘Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines was low for children and adults for the 2023-24 respiratory illness season. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.
    • “Season Outlook
      • “CDC expects the upcoming fall and winter virus season will likely have a similar or lower peak number of combined hospitalizations from COVID-19, influenza, and RSV compared to last year. However, peak hospitalizations from all respiratory viruses remain likely to be substantially higher than they were before the emergence of COVID-19. COVID-19 activity this fall and winter will be dependent on the progression of the ongoing summer COVID-19 wave. Influenza and RSV seasons generally begin in October, although they can vary in timing and burden. Read the entire 2024-2025 Respiratory Season Outlook here.
      • “CDC will update this outlook every two months during the fall and winter virus season and if there are big changes in how COVID-19, flu, or RSV are spreading.”
  • The University of Minnesota’s CIDRAP adds,
    • “New research from a randomized controlled trial presented at the European Respiratory Society (ERS) Congress in Vienna, Austria, this week suggests that simple saline nasal drops can reduce the length of the common cold in children by 2 days, according to an ERS news release.
    • “The authors also said using saline nasal drops can reduce forward transmission often virus to household members.”
  • The Wall Street Journal reports
    • “The Food and Drug Administration starting Sept. 10 will require that women nationwide be notified whether their mammograms reveal dense breast tissue. Mammography reports will also encourage women to speak with doctors about their breast density and personal risk.
    • “Nearly 40 states already require that women be notified about dense breast tissue. But there isn’t consensus on what to do with such results. Many doctors encourage women with dense tissue to consider additional tests including an ultrasound or MRI. Others say further tests could lead to unnecessary procedures. Some aren’t caught up on the trade-offs.
    • “The U.S. Preventive Services Task Force, a government-backed group that sets guidance on screening and preventive care, says there isn’t enough evidence to recommend more testing. And insurance coverage for ultrasounds or MRIs varies by state and insurer. 
    • “It’s a very challenging, patchwork landscape,” said Dr. Wendie Berg, a radiologist and breast-imaging researcher at the University of Pittsburgh. “And it’s hard to see women who could have had a better outcome and just didn’t know.” 
  • Healio adds,
    • “Less than three in 10 women are aware that a healthy diet can help reduce the risk for breast cancer, according to a recent survey.
    • “Public education programs on breast cancer have focused on mammograms, which play a vital role, but are not enough,” Neal Barnard, MD, president of the Physicians Committee for Responsible Medicine (PCRM), said in a press release. “It is essential to empower people with steps they can take to protect themselves, and a healthy diet is at the top of the list.”
  • Per BioPharma Dive,
    • “GSK on Friday said its Nucala medicine succeeded in a Phase 3 study of patients with chronic obstructive pulmonary disease, offering the British drugmaker another shot at an expanded approval for the drug
    • “The trial, known as MATINEE, included COPD patients suffering from chronic bronchitis and/or emphysema who were already taking inhaled therapies and showed evidence of a certain type of inflammation. Adding Nucala to the patients’ treatment regimens significantly reduced disease exacerbations compared with placebo, GSK said.
    • “Researchers followed the progress of patients in the study for as long as two years, GSK said. The company didn’t release detailed data on safety or efficacy but said the preliminary results on side effects were consistent with previous research on Nucala.”

From the U.S. healthcare business front,

  • The Peterson-KFF Health System Tracker projects that “In the private insurance market, 57.4 million adults under 65 could be potentially eligible for GLP-1 drugs.”
    • “These broad estimates indicate the potential number of non-elderly adults who meet the clinical criteria for GLP-1 drugs, although employers and insurers may have more restrictive eligibility standards for coverage. Additionally, because many people with diabetes or who are overweight may control their condition with diet, other medications and therapies, or choose to not seek treatment, not all people who meet these clinical criteria would use GLP-1 drugs. This analysis of survey data finds that over 40% of adults under 65 with private insurance could be indicated for a GLP-1 drug though relatively few have a claim, suggesting that a much smaller share seeks treatment through healthcare providers. Therefore, the potential market size for GLP-1 drugs suggests the broadest possible impacts on private insurance premiums and health system spending.”
  • Not surprisingly, Beckers Hospital Review points out,
    • Pharmaceutical company Eli Lilly may become the first healthcare company to hit a market value of $1 trillion, according to a Sept. 5 CNBC report. 
    • This growth is fueled by the company’s popular weight loss and diabetes drugs, Zepbound and Mounjaro. When discussing its second-quarter results in August, company officials said the two drugs accounted for almost 40% of Eli Lilly’s total sales.
    • Eli Lilly’s current market value is close to $900 million, as of this writing.
  • STAT News reports,
    • “Private equity firms are leading the buyout of R1 RCM, a major provider of billing and administrative services for hospitals and physician groups. But R1’s hospital customers — some of the biggest systems in the country — were influential in steering the company to that outcome.
    • “Ascension, a nonprofit Catholic health system, is R1’s largest client and biggest shareholder through an investment fund with private equity firm TowerBrook Capital Partners. Throughout the process of taking R1 private, Ascension and TowerBrook had no intention of giving up their ownership of R1, according to new financial disclosures from R1. TowerBrook ultimately partnered with private equity firm Clayton, Dubilier & Rice on the $8.9 billion deal.
    • “The company’s other largest customers — the nonprofits Intermountain Health, Providence, and Sutter Health and the for-profit Lifepoint Health — also supported Ascension and TowerBrook preparing a takeover offer to rival New Mountain Capital. New Mountain is a private equity firm and R1’s second-largest shareholder. It started the R1 sweepstakes in February by offering to buy the company at $13.75 per share.”
  • Speaking of New Mountain Capitol, Healthcare Dive notes,
    • “New Mountain Capital is combining three of its portfolio companies to create a new payment accuracy firm for health plans, the private equity firm said Thursday.
    • “The deal will merge The Rawlings Group, an analytics firm that finds third parties responsible for paying medical claims, the payment integrity platform of health tech provider Apixio and overpayment identification firm Varis. 
    • “David Pierre, previously the chief operating officer of home healthcare company Signify Health, will head up the newly combined company.”

Midweek update

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

From Washington, DC

  • Roll Call reports,
    • “Speaker Mike Johnson is prepping a stopgap funding extension ahead of this month’s deadline that combines some red meat for conservatives with policies that lawmakers in both parties will likely find attractive.
    • “According to sources familiar with the discussions, the Louisiana Republican’s plan would pair a six-month continuing resolution with House-passed legislation aimed at ensuring noncitizens can’t vote in federal elections.
    • “The length of the stopgap measure, if enacted, would ensure that lawmakers won’t get jammed with a lame-duck omnibus package right before Christmas, while punting final spending decisions into the new year and a new Congress — possibly with more GOP leverage to shape the outcome.
    • “In addition, the measure is expected to include a one-year extension of farm bill programs that would otherwise expire Sept. 30, since neither chamber’s multiyear reauthorization package has reached the floor and won’t be reconciled by the deadline.
    • Billions of dollars to address shortfalls in Department of Veterans Affairs programs identified by the department over the summer as well as in the Federal Emergency Management Agency’s main disaster relief account will be included as well, according to sources familiar with the talks.
    • “The current plan is to take up the measure next week when the House returns from its summer break. At least in theory, that would give a reluctant Senate time to make tweaks and send back a new version before the Sept. 30 deadline to avert a partial government shutdown.”
  • Per Modern Healthcare,
    • “Steward Health Care Chief Executive Officer Ralph de La Torre has informed senators he won’t participate in an upcoming hearing probing the hospital operator’s failure until after its bankruptcy has concluded.
    • “Lawyers for de la Torre also said in a Wednesday letter to Bernie Sanders, a Vermont independent, that members of the Senate health committee which Sen. Sanders chairs are attempting to turn an upcoming Sept. 12 hearing “into a pseudo-criminal proceeding in which they use the time, not to gather facts, but to convict Dr. de la Torre in the eyes of public opinion.” The Senate committee in a bipartisan vote authorized the investigation and subpoena of de la Torre to testify.
    • Sanders’ office did not immediately respond to a request for comment.
  • and
    • “Telehealth industry and mental health groups are scrambling amid fears the Drug Enforcement Administration is poised to place strict limits on remote prescribing of controlled substances such as Adderall and Vicodin.
    • “The legal authority for clinicians to prescribe DEA-regulated medications through platforms such as Talkiatry expires in less than four months, and the law enforcement agency has moved slowly to issue a final rule after the draft version released last year triggered protests from providers and telehealth companies.
    • “Anxiety among telehealth stakeholders soared last Wednesday, when Politico Pro reported the DEA intends to produce a regulation that would narrow the list of drugs that remote providers can prescribe and require them to verify that patients aren’t seeking medicines to misuse them. That report is unconfirmed and was attributed to an unnamed former DEA official.”
  • Per Healthcare Dive,
    • “The three biggest U.S. drug distributors have agreed to pay $300 million to health plans to settle lawsuits over their role in perpetuating the deadly opioid epidemic.
    • “McKesson, Cardinal and Cencora have already shelled out billions to resolve claims that their actions made it easier for people to access highly addictive pain medication. The latest suits brought by health insurers and benefits plans argue the drug distributors’ actions forced them to cover overprescribed pills, along with treatment for their members with opioid use disorder that they would not have had to pay for otherwise.
    • “The settlement — which does not require the distributors to admit wrongdoing — was disclosed Friday in an Ohio federal court, and still requires a judge’s approval.”
  • Govexec informs us that, “The USPS inspector general found that despite accurately forecasting air demand and adequately staffing for its busiest period, the agency still saw some on-time delivery and inventory delays.”

From the public health and medical research front,

  • MedPage Today tells us,
    • “During the first season of use, respiratory syncytial virus (RSV) vaccination among older adults was associated with a substantially reduced risk of hospitalization, a test-negative, case-control study indicated.
    • “In adults 60 and over, vaccine effectiveness from October 2023 to March 2024 against RSV-associated hospitalization reached 75% (95% CI 50-87), according to researchers led by Diya Surie, MD, of the CDC in Atlanta.
    • “As reported in JAMA, effectiveness remained similar when estimated with inverse probability of vaccination weighting to balance for potential confounders (79%, 95% CI 56-90), and when analyzed across age groups: at 75% (95% CI 31-91) for adults ages 60 to 74 years and 76% (95% CI 40-91) for those age 75 and older.”
  • The New York Times lets us know,
    • “Experts say most people should get vaccinated [against the flu] between mid-September and late October. The C.D.C. recommends getting your shot by the end of October at the latest.
    • “Generally speaking, your immunity peaks a week or two after a flu shot. Even after it peaks, protection lasts five or six months. This is typically enough protection to get you through flu season, which tends to begin in October and end in March or April.
    • “There are some exceptions to those recommendations. Experts said pregnant women in their third trimester should get vaccinated now to confer flu immunity on their newborns.
    • “Some children between 6 months and 8 years old need two flu shots, four weeks apart. This includes children who have never gotten a flu shot, who have only received one dose or who have an unknown vaccination history. Experts say that for young children, an initial course of two doses provokes the best immune response to flu. Alicia Budd, the team lead of the influenza division at the C.D.C.’s National Center for Immunization and Respiratory Diseases, said children who need two doses can get their first shot now.”
  • Per the Haymarket Medical Network,
    • “Cigar and pipe smoking are independently associated with lower aryl-hydrocarbon receptor repressor gene methylation, which is linked to increased mortality and poor respiratory health outcomes, according to study findings published in Thorax.”
  • and
    • “Patients with respiratory tract infections were significantly more likely to receive antibiotic prescriptions in virtual vs in-person urgent care visits, with the higher prescription volume in virtual settings primarily driven by sinusitis diagnoses.” 
  • The Wall Street Journal reports,
    • “The rate of preeclampsia and other disorders in pregnancy related to high blood pressure more than doubled between 2007 and 2019. “It’s no longer a rare finding,” said Dr. Sadiya Khan, associate professor of medicine at Northwestern University Feinberg School of Medicine. They complicate about 1 in 7 pregnancies a year, she said.
    • “They’re part of what’s become a crisis in healthcare for pregnant women and new mothers in America. The U.S. rate of maternal deaths is the highest among high-income nations and has risen since 2018, even excluding a spike during the Covid-19 pandemic. The rate was 22.3 deaths per 100,000 live births in 2022, up from 17.4 in 2018, according to the Centers for Disease Control and Prevention.
    • “About two-thirds of maternal deaths occur postpartum—a period researchers and doctors increasingly refer to as the “fourth trimester.” Researchers say that postpartum home visits by medical staff and guaranteed paid leave are more common in other high-income nations than in the U.S., factors that can help prevent deadly complications.
    • “Cardiovascular causes—including preeclampsia—were behind about a third of U.S. maternal deaths in 2020. Doctors don’t know why for sure, but possible risk factors include poor diet, obesity, older age and stress. More young people are in worse heart health than in previous generations, said Khan, a cardiologist. Other top causes of maternal death include suicides, drug overdoses and hemorrhages.”
  • and
    • “Please clean the microwave! 
    • “That lunchroom advice has been put to the test by researchers who looked for bacteria inside microwave ovens and found a surprisingly diverse ecosystem that is resistant to the appliances’ heat.
    • “It’s not the same thing to warm up fish or pasta, and then to warm up these tiny microorganisms that may be mixed with some fat in a very thin layer on top of this glass tray that is inside the microwave,” said Manuel Porcar, a researcher at the University of Valencia and chief executive of Darwin Bioprospecting Excellence, a Spanish biotechnology firm.” * * *
    • “The kitchen microwaves had a greater mass of microbes, they found, while the laboratory microwaves hosted greater diversity. 
    • “To rid a microwave of the germs, Porcar said using soap or diluted bleach will do the trick.
    • “Microwaves are as clean or as dirty as the surface of your kitchen table,” he said. “This means that you must not forget to clean it.”
    • “The findings were published in August in the journal Frontiers in Microbiology.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health Care Service Corp. is offering large employers a simplified healthcare plan that doesn’t include any deductibles or coinsurance and incentivizes using providers with “the highest-quality, cost-effective health outcomes,” the Chicago-based parent of Blue Cross & Blue Shield of Illinois announced today.
    • “The streamlined alternative plan for large, national self-funded health insurance calls for members to select their providers and receive an upfront estimate of what out-of-pocket costs to expect. At the time of service, the patient pays nothing, but instead receives a bill at the end of the month, HCSC said in a press release.”
  • and
    • “Humana previewed its Medicare Advantage strategy for the coming plan year, including a decision to quit 13 counties where performance has been unsatisfactory, at the Wells Fargo Healthcare Conference on Wednesday.
    • “The Medicare Advantage heavyweight, which had 6.2 million members in those plans as of the second quarter, expects to lose a few hundred thousand enrollees in 2025 as it prioritizes profitable markets, Chief Financial Officer Susan Diamond told investors at the event in Everett, Massachusetts.
    • “In addition to leaving those 13 counties, Humana will offer fewer plans in some other areas, Diamond said. About 560,000 members will have to choose new policies for 2025, most of whom will have other Humana plans available to them, she said.
    • “The exit itself is positive in the sense that those plans were not contributing. And so just exiting, even if we don’t retain the members, is positive,” Diamond said.”
  • and
    • “Companies that have profited from the largesse of Medicare Advantage insurers seeking to lure customers with generous perks are looking ahead to a tough 2025.
    • “Humana and CVS Health subsidiary Aetna are among those signaling that curtailing supplemental benefits such as transportation, fitness memberships, in-home support services, and vision, dental and hearing coverage will be a key part of their strategies to restore margins in a business troubled by high costs and a more restrictive regulatory environment.”
  • Per Fierce Healthcare,
    • “After weathering a few years of COVID-19 interruptions, hospitals are now riding a wave of strong demand for acute care services.
    • “Second-quarter earnings from several major health systems have outlined year-over-year gains across several patient volume metrics. Industrywide data reports have outlined a similar demand recovery trend, as well as the accompanying revenue gains.
    • ‘But the recovery can’t and won’t last forever, warned Tenet Healthcare CEO Saum Sutaria, M.D.. Once hospitals and health systems have made it to the other end of the upturn—likely sometime after 2025, he predicted—it’ll be the organizations that grew their service lines or expanded their capacity without increasing their cost base “as aggressively” that find long-term success. 
    • “While the industry is benefitting from a lot of this demand—and probably some of the financial benefit from the expansion of the exchanges … due to redetermination—ultimately, the discipline around operating efficiency when you end up in a normal demand environment is what’s going to allow you to grow earnings,” the CEO said Wednesday at the 2024 Wells Fargo Healthcare Conference. “That has always been the case in this industry, and I think it will always be the case.”
  • Per Beckers Hospital Review,
    • “Epic reported $4.9 billion revenue last year while expanding its market share, growing the Cosmos database and adding artificial intelligence-driven capabilities, according to CNBC.
    • “The company would have around $45 billion valuation based on S&P 500’s sub-index of software and services companies, but CEO Judy Faulkner is sticking to Epic’s first two commandments: “do not go public” and “do not be acquired.”
  • Health Affairs disclosed,
    • “The rising price of branded drugs has garnered considerable attention from the public and policy makers. This article investigates the complexities of pharmaceutical pricing, with an emphasis on the overlooked aspects of manufacturer rebates and out-of-pocket prices. Rebates granted by pharmaceutical manufacturers to insurers reduce the actual prices paid by insurers, causing the true prices of prescriptions to diverge from official statistics. We combined claims data on branded retail prescription drugs with estimates on rebates to provide new price index measures based on pharmacy prices, negotiated prices (after rebates), and out-of-pocket prices for the commercially insured population during the period 2007–20. We found that although retail pharmacy prices increased 9.1 percent annually, negotiated prices grew by a mere 4.3 percent, highlighting the importance of rebates in price measurement. Surprisingly, consumer out-of-pocket prices diverged from negotiated prices after 2016, growing 5.8 percent annually while negotiated prices remained flat. The concern over drug price inflation is more reflective of the rapid increase in consumer out-of-pocket expenses than the stagnated inflation of negotiated prices paid by insurers after 2016.”

Weekend update

David Ermer–Congress, Medical / Rx research, No Surprises Act, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

Happy Labor Day!

From Washington, DC,

  • The Hill reminds us that Congress will return to Capitol Hill for on September 9 for “a three-week sprint, during which lawmakers will face key legislative deadlines and work to push their political messages before departing again for campaign season.”
  • Federal New Network points out,
    • “OMB issued its annual Circular A-11 update in late July and the 1,079-page tome is filled with dates and instructions for how agencies should put the final touches on their 2026 budget requests.
    • “Digging deeper into the primer, agencies will find an extensive treatise on everything from improving customer experience to managing federal real property to updated requirements for using evidence and evaluation in programs. * * *
    • OMB told agencies to prepare for a 3% civilian pay raise as part of their 2026 budget planning.
  • September is the month that OPM announces the next year’s FEHB maximum government contribution and FEHB plans can start sharing their premium news publicly. Back in the day, the announcement was known as the Labor Day press release. However, the announcement has slipped over the past 40 years to the end of the month. With the big Postal Service Health Benefits Program launch set for January 1, OPM may make the announcement earlier in September 2024. It will be interesting to see how FEHB and PSHB premiums compare to one another.
  • Bloomberg has an article about an 11th Circuit No Surprises Act case worth noting.  This air ambulance claim dispute case involves a situation where the IDR arbitrator ruled in favor of the insurer, Kaiser Permanente, and the provider has challenged the arbitration award in federal court. The provider lost at the district court level and has appealed to the 11th Circuit. Here are links to KP’s appellee brief and AHIP’s amicus brief. 

From the public health and medical research front,

  • Per a National Institutes of Health press release,
    • “Research supported by the National Institutes of Health (NIH) has found that measuring two types of fat in the bloodstream along with C-reactive protein (CRP), a marker of inflammation, can predict a woman’s risk for cardiovascular disease decades later. These findings, presented as late-breaking research at the European Society of Cardiology Congress 2024, were published in the New England Journal of Medicine.
    • “We can’t treat what we don’t measure, and we hope these findings move the field closer to identifying even earlier ways to detect and prevent heart disease,” said Paul M. Ridker, M.D., M.P.H., a study author and the director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital, Boston.”
  • The American Medical Association offers advice on how to encourage communities to control hypertension.
  • Fierce Pharma lets us know,
    • “With the heart failure (HF) patient population rapidly expanding, the timing is right for Bayer’s Kerendia (finerenone). The non-steroidal mineralocorticoid receptor antagonist (MRA) was approved three years ago for chronic kidney disease (CKD) associated with Type 2 diabetes but the bulk of its market potential lies with its ability to treat HF.
    • “Four weeks ago, the company revealed that it had scored a victory in the 3 FINEARTS-HF trial. Now Bayer is putting numbers to the claim, unveiling data from the trial that showed Kerendia reduced the risk of cardiovascular death, as well as well as first and recurrent HF events by 16% compared to placebo in patients with mildly reduced (HFmrEF) or preserved ejection fraction (HFpEF).
    • “Kerendia is the first non-steroidal MRA to meet a primary composite cardiovascular endpoint in a phase 3 trial investigating HF patients with a left ventricle ejection fraction (LVEF) of more than 40%, the company said.
    • “Bayer presented the data at the European Society of Cardiology (ESC) event, Sunday in London. The results also were published Sunday in the New England Journal of Medicine.
    • “It is important to remember that there have been very few medications that have demonstrated a definitive therapeutic benefit for patients with HFmrEF and HFpEF, so we believe these results provide new insights for health care teams and patients alike, especially given the reduction in clinical endpoints like death and hospitalization and improvements in patient-reported symptoms,” Alanna Morris, Bayer’s senior medical director of US Medical Affairs, explained in an email.”
  • The Washington Post and Consumer Reports suggest treatments for sleep apnea other than the CPAP machine.
  • The New York Times reports,
    • “[While] dialysis can prolong the lives of patients with kidney failure, * * * a new study published in the journal Annals of Internal Medicine analyzed data from a simulated trial involving records from more than 20,000 older patients (average age: about 78) in the Veterans Health Administration system. It found that their survival gains were “modest.”
    • How modest? Over three years, older patients with kidney failure who started dialysis right away lived for an average of 770 days — just 77 days longer than those who never started it.
    • “I think people would find that surprising,” said Dr. Manjula Tamura, a nephrologist and researcher at Stanford and a senior author of the study. “They would have expected a greater difference.”
  • The Wall Street Journal notes,
    • “A Sanofi experimental drug for multiple sclerosis delayed disability progression in a late-stage trial, but failed to reduce episodes of new or worsening symptoms compared to an existing treatment in other clinical studies.
    • “The French pharmaceutical company said Monday that results of the clinical trials for tolebrutinib, a drug candidate taken orally and being evaluated as a treatment of various forms of multiple sclerosis, will pave the way for discussions with regulators about potentially bringing the drug to market.
    • “Sanofi’s multiple sclerosis drug Aubagio lost patent protection in key markets last year and the company has been working on a new class of drugs to treat the neurodegenerative disease, which results in accumulation of irreversible disabilities over time. Sanofi sees disability accumulation as a significant unmet medical need for patients with the disease. * * *
    • “The company said the drug met the primary goal of a phase 3 trial by delaying disability progression in patients with non-relapsing secondary progressive multiple sclerosis, a type of the disease in which patients have stopped experiencing confirmed relapses—episodes of new or worsening symptoms—but their disability continues to increase over time.”

Thursday Miscellany

David Ermer–CDC, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, OPM, U.S. Healthcare–

From Washington, DC,

  • AARP tells us,
    • “By 2029, more than 4 million people with a Medicare drug plan who do not receive the program’s low-income subsidy will hit the annual [$2000 out of pocket cost] ceiling and see savings when they go to fill their prescriptions, according to a new report published by AARP. * * * [The new cap takes effect January 1, 2025.] * * *
    • “The amount of money each person will save under the new law [the Inflation Reduction Act (IRA)}will vary depending on the medications a person takes and how much they have to pay for them. An estimated 1.4 million adults with a Medicare prescription drug plan who reach the new out-of-pocket cap between 2025 and 2029 are expected to see an average annual savings of $1,000 or more, the AARP report shows. More than 420,000 Medicare Part D enrollees will save $3,000-plus.”
    • This is one on many reasons why FEHB annuitants with Part A or B coverage should consider enrolling in an FEHB Part D EGWP plan or Medicare Advantage with Prescription Drugs (MAPD) plan for 2025. Of course, under OPM’s proposed rule, PSHB annuitants would lose their PSHB drug coverage if they opt out of participating in a Part D EGWP plan or an MAPD for 2025. The FEHBlog does not understand why OPM finds it necessary to create an opt out penalty in view of the generous Part D benefits available next year.
  • Fierce Pharma points out a report finding that the IRA’s provisions intended to juice the sales of biosimilar drugs to hospitals has had limited impact so far.
  • Per a Congressional press release,
    • “House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) today [August 28] is calling on the CEOs of three major Pharmacy Benefit Managers (PBMs)—CVS Caremark, Express Scripts, and Optum Rx—to correct the record for statements made during their appearance before the House Oversight Committee at a hearing titled, “The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part III: Transparency and Accountability.”
    • “‘At the House Oversight Committee’s hearing, the PBM chief executives made statements that contradict the Committee’s and the Federal Trade Commission’s findings about the PBMs’ self-benefitting practices that jeopardize patient care, undermine local pharmacies, and raise prescription drug prices. The chief executives for CVS Caremark, Express Scripts, and Optum Rx claimed they do not steer patients to PBM-owned pharmacies. The executives also made claims contradicting the Committee’s and FTC’s findings regarding contract negotiations, contract opt outs, and payments to pharmacies.”
    • The PBM replies are due by September 11, 2024. 
  • Tammy Flanagan, writing in Govexec, fills us in on Social Security survivor benefits.
  • Per a HRSA press release,
    • “Today, the Health Resources and Services Administration (HRSA) announces that for the first time in the 40-year history of the Organ Procurement and Transplantation Network (OPTN), the OPTN Board of Directors—the governing board that develops national organ allocation policy—is now separately incorporated and independent from the Board of long-time OPTN contractor, the United Network for Organ Sharing (UNOS). HRSA has awarded an OPTN Board Support contract to American Institutes for Research to support the newly incorporated OPTN Board of Directors. 
    • “These critical actions to better serve patients by breaking up the monopoly that ran the nation’s organ allocation system are part of the OPTN modernization plan announced by HRSA in March 2023. Prior to these steps, the national body responsible for developing organ allocation policy for the country—the OPTN—and the corporate entity contracted to implement the policy—UNOS—shared the exact same Board of Directors. The new board support contractor will be accountable to HRSA and will organize a special election for a new OPTN Board of Directors with a focus on eliminating conflicts of interest and ensuring that data, evidence, and the voices of clinical leaders, scientific experts, patients, and donor families are driving action and accountability. Moving forward, no member of the OPTN Board can sit on an OPTN vendor’s board of directors.”
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration announced a final rule that raises the minimum age for certain restrictions on tobacco product sales. These requirements are in line with legislation signed in December 2019 that immediately raised the federal minimum age of sale of tobacco products in the United States from 18 to 21 years of age. Once implemented, the requirements are expected to help decrease underage tobacco sales.  
    • “Beginning Sept. 30, retailers must verify with photo identification the age of anyone under the age of 30 who is trying to purchase tobacco products, including e-cigarettes. Previously, this requirement applied to anyone under the age of 27. It’s important for retailers to request and examine photo IDs to verify age from anyone under 30, regardless of appearance, as research has shown that it is difficult for retailers to accurately determine the age of a customer from appearance alone. 
    • “Additionally, starting Sept. 30, retailers may not sell tobacco products via vending machine in facilities where individuals under 21 are present or permitted to enter at any time. Previously, this prohibition applied to facilities where individuals under 18 were present or permitted to enter at any time. These, and the other changes made by the final rule, aim to maximize the public health impact of the original December 2019 legislation.”
  • The American Hospital Association lets us know,
    • “The U.S. Department of Health and Human Services will not appeal its loss in American Hospital Association v. Becerra. The AHA, joined by the Texas Hospital Association, Texas Health Resources, and United Regional Health Care System, last November sued HHS to bar enforcement of a new rule adopted in guidance by the Office for Civil Rights titled “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates,” which prevented hospitals and health systems from using standard third-party web technologies that capture IP addresses on key portions of their public-facing webpages. A federal district court in the Northern District of Texas June 20 held that the OCR bulletin’s new rule “was promulgated in clear excess of HHS’s authority under HIPAA.” HHS Aug. 29 officially withdrew its notice of appeal, finalizing the AHA’s victory in this case.”

From the public health and medical research front,

  • The New York Times reports,
    • “The death toll of people who consumed products tainted with listeria that have been linked to Boar’s Head deli meats has risen to nine over the last three weeks, the Centers for Disease Control and Prevention said on Wednesday.
    • “In total, 57 people have been hospitalized because of the bacteria in the outbreak that started in May, the C.D.C. said. 
    • “As a result of the outbreak, the company has recalled millions of pounds of meat. The recall includes about 70 products — including those made from ham, beef and poultry — that were manufactured at its plant in Jarratt, Va. The recall mostly affects products that are sliced at the deli counter, the company said in a statement on its website.
    • “The six new deaths are one person from Florida, one person from Tennessee, one from New York, one from New Mexico and two people from South Carolina, according to health officials.”
    • “The C.D.C. is warning people not to eat the recalled deli meats. Health officials are telling consumers to check their fridges for any recalled Boar’s Head products. (The C.D.C. is telling people to look for “EST. 12612” or “P-12612” inside the USDA mark of inspection on the product labels. Some of the products have sell-by dates that last until October 2024.)”
  • The Wall Street Journal informs us,
    • “Shingles, also called herpes zoster, is a viral infection caused by the reactivation of the virus that also causes chickenpox. The virus remains dormant in the body of anyone who’s ever had chickenpox, and can reactivate at any time.
    • “Most of us think shingles is an old person’s disease and don’t even think about it until our 60s or 70s, especially since the vaccine was long recommended for people aged 60 and over. But the reality is, it can strike at any time, triggered by stress—physical or psychological—and it is often very painful. The good news is it’s often milder at younger ages.
    • “Starting in 1998, shingles rates increased across all ages for nearly two decades, including for those in their 40s, according to Centers for Disease Control and Prevention data. Rates have stabilized somewhat recently but remain higher than the 1990s.” * * *
    • “The CDC doesn’t advise getting the shingles vaccine until you’re 50 or older, at which time people typically have no out-of-pocket cost.
    • “Typically younger people experience milder cases of shingles and are less likely to develop postherpetic neuralgia, or neuropathic pain in the area where you had shingles, which can last months.
    • “But people under 50 who are immunocompromised are more at risk of developing shingles, and the CDC recommends vaccination for those people, provided they are age 18 or over.
    • “It’s unclear how long the shingles vaccine protects against infection. Doctors say it seems to offer good protection for at least up to a decade. Currently the CDC doesn’t recommend getting a booster after the initial two-shot regimen.”  
  • The National Institutes of Health Director writes in her blog,
    • “When someone receives an inactive sugar pill for their pain, the expectation of benefit often leads them to experience some level of pain relief. Researchers have long known that this placebo effect is a very real phenomenon. However, the brain mechanisms underlying the placebo effect for pain have been difficult for researchers to understand.
    • “Now, findings from an intriguing NIH-supported study in mice published in Nature offer insight into how this powerful demonstration of the mind-body connection works in the brain. Furthermore, the researchers identified a previously unknown neural pathway for pain control and suggest that specifically activating this pathway in the brain by other means could one day offer a promising alternative for treating pain more safely and effectively than with current methods, including opioids.” * * *
    • “While the experience of pain is exceedingly complex, and this research is in mice, the researchers expect that these findings will have relevance to people. The next step is to explore the role of activity in this newly discovered pain pathway in humans’ experience of the placebo effect. The hope is that with continued study it may one day be possible to target this brain area using small molecules or neural stimulation as a potentially more effective and safer means to ease pain compared to current methods.”
  • The National Cancer Institute posted its most recent cancer information highlights.
  • Cardiovascular Business points out,
    • “Artificial intelligence (AI) is being used more and more to perform opportunistic screening of computed tomography (CT) scans for a variety of diseases. This is believed to be one way care teams can potentially change the course of preventive care in the near future, and it has been a growing topic at radiology and cardiology conferences in recent years. 
    • “One study study presented at the Society of Cardiovascular CT (SCCT) 2024 meeting led by Brittany Nicole Weber, MD, PhD, director of the Cardio-Rheumatology Clinic at Brigham and Women’s Hospital, is shedding light on the potential of using opportunistic screening in CT scans to detect cardiovascular disease (CVD). This study explored the use of the HealthCCSng AI algorithm developed by Nanox, which was cleared by the FDA in 2021 to identify coronary artery calcium (CAC) in CT scans originally performed for noncardiac reasons. Weber said this strategy could significantly improve early detection and intervention in patients at risk for cardiovascular events. Coronary calcium is a marker of coronary disease on imaging and can be seen in any types of CT scans of the chest. The software can identify and quantify the calcium burden to risk stratify a patient without human intervention.
    • “Patients with autoimmune disorders are at a significantly higher risk for cardiovascular disease, largely due to systemic inflammation. However, many of these patients are not receiving the preventive therapies they need,” Weber explained in an interview with Cardiovascular Business.” 

From the U.S. healthcare business front,

  • Kauffman Hall reports,
    • “Kaufman Hall’s National Hospital Flash Report showed another month of solid performance through the first half of 2024 with a 4.1% operating margin year to date, continuing a trend of stronger performance that began in late 2023. It’s as if a light bulb turned on and has stayed on, setting up 2024 to be a better year than 2023.
    • “Before we declare victory, there are few noteworthy caveats.
      • “First, not all margins are created equally. While the month-over-month median shows improvement, the median change in margin is down, suggesting an uneven distribution of the improvement. About two-thirds of hospitals in the data through 2023 showed no change in operating margin compared to 2019. Many hospitals are running hard but running in place. This means that the improvement in the margin rests on the herculean shoulders of the remaining one third that are doing well—really well, in fact—to drive the national median up.
      • “Second, the Flash report typically reflects only a hospital’s acute care operations. If one were to add in physician enterprises and other similar non-acute care operations that negatively impact performance, margins would decline by about 200 basis points. This would bring our Calendar Year 2023 median of 2.7% in line with FY 2023 rating agency medians, which reported breakeven results.
    • “Notwithstanding these caveats, performance through the first half of 2024 suggests much improved results for full 2024. 
  • Per the Wall Street Journal,
    • “Luxury hotels such as the Waldorf Astoria, renowned for offering impeccable service to clientele, are now catering to an unexpected cadre of VIPs: newborns and their parents.
    • “Postnatal-wellness centers, modeled after ones in Taiwan and Korea, are popping up in American cities, quietly ensconced within tony hotels. For up to $1,500 per night, families leave the hospital and head to a retreat or check in for R & R later. They indulge in recovery, coaching in newborn care and pampering.
    • “Perhaps the most coveted service, however, is the 24-7 nursery staff, affording new parents that elusive treasure: sleep.”
  • Beckers Payer Issues provides seven payer executive answers to the question — what are the most dangerous trends facing payers? For example,
    • “Jen Truscott. Senior Vice President of Aetna Clinical Solutions (Hartford, Conn.):  According to the National Council on Aging, 80% of adults aged 65 and older have two or more chronic conditions. Many older adult patients seek care for health complications long after they have arisen. Care management can improve outcomes for health plan members when these programs are proactive and personalized, yet coordinated care is not utilized to its full extent across the U.S. To combat this, health plans should increase their emphasis on holistic care, effective care management programs and the power of value-based care. Our data show that four in 10 Aetna members changed their behavior — including reducing avoidable emergency room visits, improving medication adherence and choosing more cost-effective sites of care — due to our care management programs proactive outreach.”
  • HR Dive relates,
    • “Three in five U.S. workers reported living paycheck to paycheck, according to PNC Bank’s second annual Financial Wellness in the Workplace Report. And 31% of the more than 1,000 workers surveyed said they would like early access to their paycheck. 
    • “Meanwhile, 78% of the more than 500 U.S. employers surveyed said their workers were financially stressed, up from 71% in 2023. But access to financial planning benefits doubled from the previous year, jumping from 14% to 28%. 
    • “Three out of 10 workers of any generation and 4 out of 10 Generation Z workers with student loan debt report being “at a standstill” while they pay it off.”