FEHBlog

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.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front,

  • Federal News Network tells us,
    • “White House officials are contemplating a new cybersecurity executive order that would focus on the use of artificial intelligence.
    • “Federal cybersecurity leaders, convening at the Billington Cybersecurity Conference in Washington this past week, described AI as both a major risk and a significant opportunity for cyber defenders.
    • ‘White House Deputy National Security Advisor Anne Neuberger called AI a “classic dual use technology.” But Neuberger is bullish on how it could improve cyber defenses, including analyzing logs for cyber threats, generating more secure software code, and patching existing vulnerabilities.
    • “We see a lot of promise in the AI space,” Neuberger said. “You saw it in the president’s first executive order. As we work on the Biden administration’s potentially second executive order on cybersecurity, we’re looking to incorporate some particular work in AI, so that we’re leaders in the federal government in breaking through in each of these three areas and making the tech real and proving out what’s possible.”
  • Per a Labor Department Employee Benefit Security Administration press release,
    • “In its continuing effort to protect U.S. workers’ retirement and health benefits, the U.S. Department of Labor today updated current cybersecurity guidance confirming that it applies to all types of plans governed by the Employee Retirement Income Security Act, including health and welfare plans, and all employee retirement benefit plans.
      • “The new Compliance Assistance Release issued by the department’s Employee Benefits Security Administration provides best practices in cybersecurity for plan sponsors, plan fiduciaries, recordkeepers and plan participants. The release updates EBSA’s 2021 guidance and includes the following:
      • “Tips for Hiring a Service Provider: Helps plan sponsors and fiduciaries prudently select a service provider with strong cybersecurity practices and monitor their activities, as ERISA requires.
      • “Cybersecurity Program Best Practices: Assists plan fiduciaries and recordkeepers in mitigating risks. 
      • “Online Security Tips: Offers plan participants who check their online retirement accounts with rules for reducing the risk of fraud and loss.”
  • Cybersecurity Dive lets us know,
    • “The White House Office of the National Cyber Director launched a program Wednesday to help fill the gap of about 500,000 available cybersecurity jobs across the country. 
    • “Service for America, a program developed alongside the Office of Management and Budget and the Office of Personnel Management, is a recruitment and hiring push that will help connect Americans with available jobs in cybersecurity, technology and artificial intelligence. 
    • “The program’s major emphasis is to reach job candidates without traditional qualifications, such as computer science or engineering backgrounds. 
    • “Many Americans do not realize that a cyber career is available to them,” National Cyber Director Harry Coker Jr. said in a blog post released Wednesday. “There is a perception that you need a computer science degree and a deeply technical background to get a job in cyber.”
    • “In reality, Coker said people of all backgrounds can find well-paying jobs in cybersecurity, and the White House has been promoting efforts to connect a new generation of prospective candidates into those positions.”
  • and
    • “Marsh McLennan and Zurich Insurance Group on Thursday [September 5] issued a call for government intervention to help resolve the growing risk of catastrophic cyber events and a multibillion dollar gap in terms of what the current insurance market can absorb. 
    • “The cyber insurance market has seen significant growth in recent years, and is expected to exceed $28 billion in gross written premiums in 2027, more than double the amount written in 2023, according to a whitepaper released by the firms Thursday.  
    • “However, the companies warn a risk protection gap of about $900 billion exists between insured losses and economic losses due to cyberattacks. Many small- to medium-sized businesses are either underinsured or carry no coverage to protect against such losses.” 

From the cyber vulnerabilities and breaches front,

  • Per a Centers for Medicare Services press release,
    • “The Centers for Medicare & Medicaid Services (CMS) and Wisconsin Physicians Service Insurance Corporation (WPS) are notifying people whose protected health information or other personally identifiable information (PII) may have been compromised in connection with Medicare administrative services provided by WPS. WPS is a CMS contractor that handles Medicare Part A/B claims and related services for CMS.  
    • “The notification comes following discovery of a security vulnerability in the MOVEit software, a third-party application developed by Progress Software and used by WPS for the transfer of files in providing services to CMS. WPS is among many organizations in the United States that have been impacted by the MOVEit vulnerability. The security incident may have impacted PII of Medicare beneficiaries that was collected in managing Medicare claims as well as PII collected to support CMS audits of healthcare providers that some individuals who are not Medicare beneficiaries have visited to receive health care services.
    • “CMS and WPS are mailing written notifications to 946,801 current people with Medicare whose PII may have been exposed, informing them of the breach and explaining actions being taken in response.”
  • Cybersecurity Dive reports,
    • “Federal authorities in the U.S. and nine other countries warn that threat groups affiliated with Russia’s military intelligence service are targeting global critical infrastructure and key resource sectors, according to a joint cybersecurity advisory released Thursday. 
    • “Threat groups affiliated with a specialist unit of the Russian General Staff Main Intelligence Directorate have targeted government services, financial services, transportation systems, energy, and healthcare sectors of NATO members and countries in Europe, Central America and Asia, officials said in the advisory.
    • “To date, the FBI has observed more than 14,000 instances of domain scanning across at least 26 NATO members and several additional EU countries,” authorities said in the advisory. The attackers have defaced victim websites, scanned infrastructure, and exfiltrated and leaked stolen data.”
  • The Cybersecurity and Infrastructure Security Agency added three known exploited vulnerabilities to its catalog:
  • Dark Reading adds,
    • “This week the US Cybersecurity and Infrastructure Security Agency (CISA) warned about two new industrial control systems (ICS) vulnerabilities in products widely used in healthcare and critical manufacturing — sectors prone to attract cybercrime.
    • “The vulnerabilities affect Baxter’s Connex Health Portal and Mitsubishi Electric’s MELSEC line of programmable controllers. Both vendors have issued updates for the vulnerabilities and recommended mitigations that customers of the respective technologies can take to further mitigate risk.”
  • Per Cybersecurity Dive,
    • “Just over half of businesses in the U.S. and U.K. have been targets of a financial scam powered by “deepfake” technology, with 43% falling victim to such attacks, according to a survey by finance software provider Medius.
    • “Of the 1,533 U.S. and U.K. finance professionals polled by Medius, 85% viewed such scams as an “existential” threat to their organization’s financial security, according to a report on the findings published last month. Deepfakes are artificial intelligence-manipulated images, videos, or audio recordings that are bogus yet convincing.
    • “More and more criminals are seeing deepfake scams as an effective way to get money from businesses,” Ahmed Fessi, chief transformation and information officer at Medius, said in an interview. These scams “combine phishing techniques with social engineering, plus the power of AI.”

From the ransomware front,

  • Tech Radar points out,
    • “Research from Searchlight Cyber has shown the number of ransomware groups that operated in the first half of 2024 rose to 73, up from 46 in the same period of 2023. The findings suggest law enforcement’s efforts to curb cyber criminal groups have seen some success, especially in disrupting the operations of notorious group BlackCat, which has since dissolved.
    • “Groups were targeted by law enforcement in ‘Operation Cronos’, which facilitated the arrests of two people, took down 28 servers, obtained 1,000 decryption keys, and froze 200 crypto accounts – all linked to the infamous LockBit organization.
    • “Although the number of groups has risen, the number of victims has fallen, which indicates a potential diversification rather than growth of ransomware groups. Other Ransomware as a Service (RaaS) groups such as RansomHub and BlackBasta have become more active, complicating the landscape for cyber security.
  • Tripwire fills us in about Cicada ransomware.
  • ‘Per Cybersecurity Dive,
    • “A previously disclosed cyberattack at Halliburton disrupted parts of its operations and information was stolen in connection with the incident, the company said in a filing with the Securities and Exchange Commission Tuesday. 
    • “Halliburton discovered the attack in late August and immediately shut off certain services as a proactive measure. It continues to offer its products and services across the globe, the company said.
    • “The Houston company has incurred and will continue to incur certain expenses related to the attack. However, it does not expect the attack to have a material impact on its financial condition or results of operations.”

From the cybersecurity defenses front,

  • The Wall Street Journal reports,
    • “Cybersecurity professionals are reporting modest budget increases amid the need to defend against new hacking threats and secure emerging technologies such as artificial intelligence.
    • “Spending on cybersecurity is rising 8% this year, compared with 6% in 2023, according to a survey of chief information security officers published Thursday by cybersecurity consulting firm IANS and recruiting company Artico Search. The survey polled 755 CISOs from April into August, with 681 completing its budget section.
    • “Despite the small improvement, security spending is growing at a lower rate than the 17% increase in 2022. Still, the shift indicates a gradual recovery after companies slowed cyber spending and in some cases froze hiring after the pandemic, said Steve Martano, an Artico partner and IANS faculty member. 
    • “People are feeling more optimistic than they were six months ago,” Martano said, adding that more cybersecurity leaders are seeing small budget increases and there are signs the security job market will improve.”
  • Dark Reading offers a commentary on “How CISOs Can Effectively Communicate Cyber-Risk. A proximity resilience graph offers a more accurate representation of risk than heat maps and risk registers,and allows CISOs to tell a complex story in a single visualization.”
  • ISACA offers a commentary on “The Never-ending Quest: Why Continuous Monitoring is Crucial for Cybersecurity.”
  • If you work for or represent a small or medium sized HIPAA covered entity or business associate, you may want to “register for an introductory webinar [to held on September 10 at noon ET and September 11 at 3 pm] on the free Security Risk Assessment Tool (SRA Tool) hosted by Altarum with the U.S. Department of Health and Human Services Office for Civil Rights (OCR) and the Assistant Secretary for Technology Policy (ASTP). The webinar will also feature changes in SRA Tool version 3.5, available in September 2024.”
  • Security Week shares a discussion between CSOs Jaya Baloo from Rapid7 and Jonathan Trull from Qualys about the route, role, and requirements in becoming and being a successful CISO.

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.”

Thursday Miscellany

David Ermer–AHRQ, CMS, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Per an HHS press release,
    • “Today, leaders from the U.S. Department of Health and Human Services (HHS), the Office of National Drug Control Policy (ONDCP), and the Substance Abuse and Mental Health Services Administration (SAMHSA) joined recovery advocates to kick off observance of the 35th National Recovery Month at the second annual SAMHSA Walk for Recovery. The National Walk for Recovery supports and celebrates recovery from substance use and/or mental health conditions while reducing stigma.
    • “In addition to hosting the walk, SAMHSA published the Gallery of Hope which features over 250 visual art entries submitted to the Art of Recovery project. The gallery highlights the transformative impact of art on mental health and substance use recovery. * * *
    • “Recovery Month, observed every September since 1989, promotes evidence-based substance use disorder and mental health treatment and recovery support practices and serves as an opportunity to celebrate the achievements of tens of millions of people in recovery and reduce stigma surrounding substance use and mental health issues. Over 65 million people consider themselves in recovery from substance use and/or mental health issues according to the 2023 National Survey on Drug Use and Health (NSDUH), among adults 18 or older in America. SAMHSA’s National Recovery Month Toolkit is available online and features recovery resources, social media assets, and weekly themes and messaging.”
  • American Hospital Association News lets us know,
    • “The Centers for Medicare & Medicaid Services Sept. 5 published a list of participants for the Transforming Episode Accountability Model. TEAM is a mandatory payment model that will bundle payment to acute care hospitals for five types of surgical episodes. The AHA June 10 urged CMS to make the model voluntary, however the mandatory model was finalized in the CY 2025 Inpatient Prospective Payment System Final Rule.”
  • Per Fierce Pharma,
    • “A year after missing on a trial endpoint, Travere Therapeutics can breathe a sigh a relief. The FDA has converted Filspari’s conditional nod in the kidney disease IgA nephropathy (IgAN) into a full approval.
    • “As part of the conversion Thursday, the FDA has removed a specific urine protein level requirement from Filspari’s label. Now, the only condition for treatment with Filspari is that patients be at risk of disease progression.
    • The adjustment will allow Filspari to reach more patients who’re at lower risk of progression, Travere CEO Eric Dube, Ph.D., said in a recent interview. The company will be able to promote Filspari’s ability to preserve kidney function, and the full approval could give more doctors confidence to start using the drug, he added.
    • During a drug launch, “those later adopters oftentimes look for things like guidelines, support or advocacy from their peers, or in this case, also full approval,” Dube said. “So we do expect that there’s going to be a broader set of nephrologists prescribing.”
  • Federal News Network informs us,
    • “The Postal Service is bringing back a holiday surcharge for some of its package services, as the agency prepares for its busy year-end peak season.
    • “The new prices will take effect on Oct. 6, 2024, and will last through Jan. 19, 2025. USPS announced the return of the holiday surcharge in a press release Thursday.
    • “USPS waived the surcharge last year, in the hopes that that lower prices would help the agency capture a bigger share of the lucrative holiday package business from private-sector competitors like UPS, FedEx and Amazon.
    • “USPS said in a press release Thursday that the temporary price adjustment will “help cover extra handling costs to ensure a successful peak season.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “The California Department of Food and Agriculture Aug. 30 reported cows in three dairy herds tested positive for bird flu. No human cases were confirmed in association with this incident. Both the California Department of Health and the Centers for Disease Control and Prevention consider the risk of bird flu to the general public as low. As of yesterday, there have been 13 total positive cases of H5 bird flu in humans, according to the CDC.” 
  • The New York Times reports,
    • “The number of teenagers who reported using e-cigarettes in 2024 has tumbled from a worrisome peak reached five years ago, raising hopes among public health officials for a sustained reversal in vaping trends among adolescents.
    • “In an annual survey conducted from January through May in schools across the nation, fewer than 8 percent of high school students reported using e-cigarettes in the past month, the lowest level in a decade.
    • “That’s far lower than the apex, in 2019, when more than 27 percent of high school students who took the survey reported that they vaped — and an estimated 500,000 fewer adolescents than last year.
    • “The data is from the National Youth Tobacco Survey, a questionnaire filled out by thousands of middle and high school students that is administered each year by the Food and Drug Administration and the Centers for Disease Control and Prevention.”
  • The Washington Post points out,
    • “A new study adds to a growing body of evidence that Parkinson’s disease, long believed to have its origins in the brain, may begin in the gut.
    • “Gastrointestinal problems are common in patients with neurodegenerative disorders, to the point where a condition known as “institutional colon” was once thought to afflict those who lived in mental health institutions. In Parkinson’s disease, the entire gastrointestinal tract is affected, causing complications such as constipation, drooling, trouble swallowing and delayed emptying of the stomach. These symptoms often appear up to two decades before motor symptoms such as rigidity or tremor.
    • “People have, for the longest time, described Parkinson’s disease as a top-down disease — so, it starts in the brain and then percolates down to the gut, and that’s why patients have issues with their gastrointestinal tract,” said study author Subhash Kulkarni, an assistant professor at Beth Israel Deaconess Medical Center. “Another hypothesis suggests that, in many patients, it may be a bottom-up approach, where it starts in the gut and goes all the way up to the brain.”
    • “Kulkarni and his colleagues found that people with upper gastrointestinal conditions — in particular, ulcers or other types of damage to the lining of the esophagus, stomach, or upper part of the small intestine — were far more likely to develop Parkinson’s disease later in life. The study was published online Thursday in JAMA Network Open.”
  • The NIH Director writes in her blog,
    • “Each year in the U.S. there are about 18,000 new spinal cord injuries, which damage the bundle of nerves and nerve fibers that send signals from the brain to other parts of the body and can affect feeling, movement, strength, and function below the injured site. A severe spinal cord injury can lead to immediate and permanent paralysis, as our spinal cords lack the capacity to regenerate the damaged tissues and heal.
    • “So far, even the most groundbreaking regenerative therapies have yielded only modest improvements after spinal cord injuries. Now, an NIH-supported study reported in Nature Communications offers some new clues that may one day lead to ways to encourage healing of spinal cord injuries in people. The researchers uncovered these clues through detailed single-cell analysis in what might seem an unlikely place: the zebrafish spinal cord.
    • “Why zebrafish? Unlike mammals, zebrafish have a natural ability to spontaneously heal and recover after spinal cord injuries, even when the injuries are severe. Remarkably, after a complete spinal cord injury, a zebrafish can reverse the paralysis and start swimming again within six to eight weeks. Earlier studies in zebrafish after spinal cord injury found that this regenerative response involves many types of cells, including immune cells, progenitor cells, neurons, and supportive glial cells, all of which work together to successfully repair damage. * * *
    • “In future work, the researchers plan to conduct similar studies in the many other cell types known to play some role in spinal cord healing in zebrafish, including supportive glia and immune cells. They’re also continuing to explore how the activities they see in the zebrafish spinal cord compare to what happens in mice and humans. With much more study, these kinds of findings in zebrafish may lead to promising new ideas and even treatments that encourage neural protection, flexibility, and recovery in the human nervous system after spinal cord injuries.”
  • The “Institute for Clinical and Economic Review publishes Evidence Report on treatments for Transthyretin Amyloid Cardiomyopathy — Current evidence suggests that tafamidis and acoramidis provide a net health benefit when compared to no disease-specific therapy; these treatments would achieve common thresholds for cost-effectiveness if priced between $13,600 to $39,000 per year.” * * * “This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC on September 20, 2024.”
  • The U.S. Preventive Services Task Force posted a final research plan for “Early Allergen Introduction to Prevent Food Allergies in Infants: Counseling.
  • Per Reuters,
    • “There is no link between mobile phone use and an increased risk of brain cancer, according to a new World Health Organization-commissioned review of available published evidence worldwide.
    • “Despite the huge rise in the use of wireless technology, there has not been a corresponding increase in the incidence of brain cancers, the review, published on Tuesday, found. That applies even to people who make long phone calls or those who have used mobile phones for more than a decade.”
  • FEHBlog comment: Whew!
  • Per MedPage Today,
    • “Having a medical condition was associated with an increased risk of suicide in a dose-response-like manner, such that the higher the burden of disability, the higher the risk of suicide, according to an observational study in Denmark.
    • “An analysis of more than 6.6 million people found that nine medical condition categories including 31 specific conditions were associated with a statistically significant increased risk of suicide, with the exception of endocrine disorders, reported Søren Dinesen Østergaard, MD, PhD, of Aarhus University Hospital, and co-authors.
    • “The associations were most pronounced for gastrointestinal conditions (incidence rate ratio [IRR] 1.7, 95% CI 1.5-1.8), cancers (IRR 1.5, 95% CI 1.4-1.6), and hematological conditions (IRR 1.5, 95% CI 1.3-1.6), they wrote in JAMA Psychiatry.
    • “The risk was highest in the first 6 months following diagnosis and subsequently faded over time, although the risk after certain medical conditions remained elevated up to 15 years after onset.”

From the U.S. healthcare business front,

  • Beckers Payer Issues provides context to Modern Healthcare’s story in yesterday’s post about HCSC offering a no deductible plan design. It’s a trend.
  • Modern Healthcare adds today,
    • “Cigna Group CEO David Cordani underscored the booming state of the company’s health services business and outlined the unit’s potential growth opportunities during Morgan Stanley’s annual Global Healthcare Conference on Thursday.
    • “Cordani said the company sees opportunities to capitalize on the $400 billion specialty pharmacy market and to drive more business for its pharmacy benefit manager, Express Scripts.
    • “Cigna has been charting strong growth this year for its Evernorth Health Services business as it pulls out of the lucrative Medicare Advantage market, and it’s already seeing positive returns. Evernorth, which houses Cigna’s specialty pharmacy and pharmacy benefits businesses, generated more than 80% of its total revenue in the second quarter ended June 30.
    • “Cordani highlighted Evernorth’s successes as the segment announced another low-cost biosimilar product. Early next year, eligible members will have access to a biosimilar for Johnson & Johnson’s Stelara arthritis drug with no out-of-pocket cost at its specialty pharmacy. Cordani said the new offering could save each member $4,000 annually.”
  • Per Fierce Healthcare,
    • “Over the past several years, Humana has made significant strides in growing its senior-focused primary care business, and a new study highlights areas where it’s seeing success in this model.
    • “The study, conducted by the Humana Healthcare Research team along with Harvard researcher J. Michael McWilliams, M.D., Ph.D., digs into data from six senior-focused primary care organizations on more than 421,000 patients who were enrolled in Medicare Advantage coverage in 2021.
    • “It found that patients in these organizations had 17% more primary care visits across the board. This included 39% more visits among Black patients and 21% more among low-income patients, which can address disparities faced by these populations.
    • “The study also suggests that patients who are engaged with a senior-focused primary care model see better outcomes on multiple quality measures including cancer screenings, medication adherence and controlled blood pressure. The researchers did note that future analysis is necessary to refine these findings.”
  • Modern Healthcare notes,
    • “Ochsner Health is expanding its digital medicine program to offer weight management, the health system said Wednesday.
    • “Some [program] patients will have access to popular weight loss medications including glucagon-like peptide agonists, Ochsner said in a release. The digital medicine program has previously focused on patients with hypertension, Type 2 diabetes and hyperlipidemia.” * * * 
    • “Ochsner is the latest organization seeking to leverage the popularity of GLP-1 medications such as Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. GLP-1s have led many organizations to offer virtual weight management services, including Mayo Clinic. The Rochester, Minnesota-based organization said in January it’s testing a telehealth weight loss offering through its diet program.”  
  • Per Healthcare Dive,
    • “Henry Ford Health and Ascension will launch their joint venture in Michigan at the start of October, moving eight Ascension and Genesys hospitals and an addiction treatment center under the Henry Ford brand, the companies said on Wednesday.
    • “Detroit-based Henry Ford will double in size once the joint venture launches, growing its acute care footprint from five to 14 hospitals.
    • “The no-cash deal, announced nearly a year ago, is expected to create an organization with more than $10.5 billion in annual operating revenue. Henry Ford CEO Bob Riney will serve as the CEO of the new entity.”
  • and
    • “Female physicians and doctors who work in nonrural practices deliver more care via telehealth, according to a study published this week in Health Affairs. 
    • “The research also found differences in virtual care utilization by specialty. For example, 23% of psychiatrists delivered all or nearly all of their visits through telehealth, compared with fewer than 1% for physicians in all other specialties. 
    • “The findings offer insight into long-term patterns of telehealth utilization in the U.S. and help show how virtual care might be affecting care access and outcomes, the study authors wrote.”
  • Per Kauffman Hall,
    • Hospital financial performance remains strong this year, with continued stabilization in the month of July. Outpatient revenue and average lengths of stay showed signs of improvement.
    • The median Kaufman Hall Calendar Year-To-Date Operating Margin Index reflecting actual margins for July was 4.1%.
    • The recent [/July] issue of the National Hospital Flash Report covers these and other key performance metrics.
  • Per MedTech Dive,
    • “Abbott is working to integrate its newest continuous glucose monitor (CGM) with Beta Bionics’ automated insulin delivery (AID) system.
    • “The companies plan to connect Beta Bionics’ iLet Bionic Pancreas to Abbott’s Freestyle Libre 3 Plus CGM, according to the Wednesday announcement. Readings from the CGM will help iLet calculate insulin doses for automated delivery.
    • “Beta Bionics said the integration, which is scheduled to launch in the fourth quarter, will be the first of its kind for Freestyle Libre 3 Plus in the U.S. Abbott also has AID partnerships with Insulet and Medtronic.”

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.”

Tuesday’s Tidbits

David Ermer–Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • The Washington Post reports,
    • “The Supreme Court on Monday cleared the way for the Biden administration to strip millions of health care dollars from Oklahoma over its refusal to refer patients for abortions – a practice the state says would be at odds with its strict ban on terminating pregnancies.”
  • and
    • “As updated coronavirus vaccines hit U.S. pharmacy shelves, adults without health insurance are discovering the shots are no longer free, instead costing up to $200.
    • “The federal Bridge Access Program covering the cost of coronavirus vaccines for uninsured and underinsured people ran out of funding. * * *
    • At least 34 million doses of last year’s vaccine were administered to adults, according to the Centers for Disease Control and Prevention. Of those, 1.5 million were funded through the Bridge Access Program, * * *.
  • Per Federal News Network,
    • “The Department of Veterans Affairs’ hospitals are scoring higher than non-VA hospitals on two nationwide surveys that track patient satisfaction and care quality.
    • “Nearly 80% of VA medical facilities received a four or five-star rating in the most recent Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) conducted by the Centers for Medicare & Medicaid Services.
    • “By comparison, 40% of non-VA hospitals received those same star ratings. CMS based its latest HCAHPS scores on data collected between October 2022 and September 2023.
    • “HCAHPS measures patient satisfaction after they’re discharged from the hospital, and tracks 10 criteria — including staff communication and responsiveness, hospital environment of care, willingness to recommend the hospital, and overall hospital rating.
    • “This marks the ninth consecutive quarter in which VA facilities outperformed their non-VA counterparts on this scorecard.”
  • Reg Jones, writing in FedWeek, explains “how [a federal employee’s] retirement will be calculated when they retire.”

From the public health and medical research front,

  • CNN reports,
    • “Measuring the levels of three biomarkers in blood in midlife may give women a clearer picture of their risk of major cardiovascular events like heart attacks and strokes decades earlier than current risk calculators do, a new study suggests.
    • “When it comes to the worries that women have about their health, heart disease isn’t usually at the top of the list – but it probably should be.
    • “Heart disease is the No. 1 killer of women in the United States. In 2021, it was responsible for the deaths of more than 310,000 women, about 1 in every 5 female deaths, according to the US Centers for Disease Control and Prevention. About 80% of women ages 40 to 60 are living with at least one risk factor for coronary artery disease, research has found, but only about half of women recognize heart disease as their biggest health risk.
    • “Experts say that having better measures of risk earlier in life might help women take critical steps to improve their health before it’s too late.
    • ‘The tests highlighted in the study are not new. “These are widely available. It’s nothing more than checking off a box with a lab slip,” said study author Dr. Paul Ridker, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital. They are also inexpensive, he says, ranging from $10 to $12 per test.
    • “The study found that these three test results, considered together, could predict cardiovascular risk in seemingly healthy women as much as 30 years before a major cardiovascular event like a heart attack or stroke, a finding that Ridker said was astonishing.”
  • Per Health Day,
    • “In some people, new-onset depression may stem from the same buildup of toxic plaques in the brain that have long been linked to Alzheimer’s disease, according to a new study.
    • “Our findings provide additional support for depressive symptoms as an early feature of preclinical Alzheimer’s disease,” wrote a team led by Catherine Munro. She’s a neuropsychologist at Brigham and Women’s Hospital in Boston. 
    • “It’s not that depression caused Alzheimer’s disease, it’s just that Alzheimer’s disease pathology affecting this part of the brain resulted in depressive symptoms relatively early on in the course,” explained another expert, Dr. Marc Gordon, who wasn’t involved in the study.  
    • “He’s chief of neurology at Northwell’s Zucker Hillside Hospital in Great Neck, N.Y.”
  • Roll Call lets us know,
    • “Treating and screening for non-substance-related mental health disorders could help drive down overdoses, a new study by the Centers for Disease Control and Prevention found. 
    • “The study, published Thursday, found that of the 63,424 people who died from drug overdoses across 43 states and Washington, D.C. in 2022, 22 percent had a separate mental health disorder. Analyzing data from the CDC’s State Unintentional Drug Overdose Reporting System, the researchers found that the most common disorders were depression, anxiety and bipolar. 
    • “The authors noted the rates of mental health disorders are likely underestimated.” 
  • The New York Times adds that “Some researchers argue that the roles of social environment and personal choice have to be considered in order to make progress in treating people addicted to drugs.”
  • Per BioPharma Dive,
    • “Regulators in the U.S. and Europe recently determined that a popular group of drugs for weight loss and diabetes don’t heighten the risk of suicide. New data published in the Journal of the American Medical Association on Tuesday appear to back up those assessments, though researchers cautioned that there’s still more work to be done.
    • “The findings come from a pair of large, retrospective evaluations. One reviewed the effects of a so-called GLP-1 drug or another diabetes medication on the risk of suicide or other mental health problems in nearly 300,000 people in Sweden and Denmark. The other looked at the incidence of suicidal thoughts or depression symptoms in 3,600 study volunteers who received the obesity drug Wegovy or a placebo in studies Novo Nordisk ran to secure regulatory approval.
    • “Taken together, the two studies found there wasn’t a greater risk of suicide or poor mental health outcomes in people taking GLP-1s instead of a placebo or comparator drug. The results are notable, as millions of people already take these medicines to lower blood sugar and weight. Adoption is expected to climb in the years ahead as their use is broadened to include other conditions. But in an accompanying editorial, researchers warned that the findings are part of an “incomplete puzzle” that will require further study.”
  • and
    • “Shares in vaccine developer Vaxcyte soared by over 35% Tuesday after the company unveiled results from a large study testing its experimental pneumococcal shot which analysts described as a best-case scenario.
    • “Data from the Phase 1/2 trial showed Vaxcyte’s vaccine matched the effectiveness of Pfizer’s market-leading Prevnar 20 in protecting against 20 common strains of the bacteria that causes invasive pneumococcal disease, the company said.
    • “Vaxcyte’s shot covers an additional 11 strains than Prevnar 20, for a total of 31. The company plans to advance its vaccine into a Phase 3 trial program in adults. Initial data from the first study in that program could come by 2026, Vaxcyte said.”
  • Per a National Institutes of Health press release,
    • “The National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) has awarded grants for 10 projects to improve diagnostic tools for congenital and adult syphilis—conditions currently diagnosed with a sequence of tests, each with limited precision. 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—a crisis that prompted the U.S. Department of Health and Human Services (HHS) to establish a national taskforce to respond to the epidemic.  
    • “Syphilis antibiotics work, but antiquated testing makes it very difficult to ensure that people are appropriately diagnosed and fully treated,” said NIAID Director Jeanne M. Marrazzo, M.D., M.P.H. “Advanced diagnostics could streamline syphilis care and also enhance our ability to measure the efficacy of candidate syphilis vaccines and other prevention modalities.”

From the U.S. healthcare business front,

  • Beckers Payer Issues tells us five things to know about UnitedHealthcare’s gold card program, which kicks off on October 1.
  • Beckers Health IT offers four leadership predictions on the future of artificial intelligence in healthcare.
  • Beckers Hospital Review points out,
    • “Philadelphia-based Rite Aid has completed financial restructuring and successfully emerged from Chapter 11 bankruptcy after the U.S. drugstore chain filed for protection last October. It will now operate as a private company, according to a Sept. 3 news release. 
    • “Throughout its Chapter 11, the company has cut around $2 billion in debt and received around $2.5 billion in exit financing. The pharmacy retail chain has also closed more than 520 stores since filing for bankruptcy.
    • “Emergence is a pivotal moment in Rite Aid’s history, enabling it to move forward as a significantly transformed, stronger and more efficient company,” Jeffrey Stein, CEO and Chief Restructuring Officer of Rite Aid, said in the release.
    • “Mr. Stein also shared plans to step down as the company exits Chapter 11 protection after just under one year in the role. Matt Schroeder, CFO of Rite Aid, has been appointed CEO, according to another Sept. 3 news release.”
  • and
    • how 31 health systems rank by operating margins.
  • and
    • names the 20 hospitals with the lowest and highest heart failure rates. Interestingly, the lowest rates are often found in VA hospitals.
  • Per Fierce Healthcare,
    • “A monthslong contract dispute between HCA Healthcare and UnitedHealthcare has been resolved just hours before a Sept. 1 deadline would have interrupted network coverage for members in four states.
    • “Thirty-eight hospitals plus their affiliated locations and physician groups within HCA’s Texas, New Hampshire, South Carolina and Denver markets would have been affected had the industry juggernauts not struck an accord.
    • “After months of negotiations, we have reached agreement with UnitedHealthcare,” HCA Healthcare said in an emailed statement. “This means UnitedHealthcare plan members and their families will continue to have access to the convenient and quality healthcare they have come to expect from our care teams.”
  • and
    • “There’s no shortage of attention on rising pharmaceutical costs, but policymakers need to have the full picture of trends in this space to work off of, according to a new study.
    • “Researchers at the Bureau of Economic Analysis wanted to account for the role the pharmacy benefit manager-negotiated rebates play in drug pricing trends. They compared claims data with rebate estimates from 2007 to 2020 and found that retail pharmacy prices increased by 9.1% each year.
    • “Negotiated prices, however, instead grew by the more modest 4.3% per year, according to the study. In 2016, patient out-of-pocket spending also rose, while negotiated cost growth largely remained flat.
    • “Overall, the findings emphasize the importance of accurate measurement to inform policy discussions regarding prices in prescription drug markets,” the researchers wrote. “Given the data limitations, more work is needed to provide a complete and accurate picture of how pharmaceutical prices are changing in this sector of growing economic importance.”
  • Per MedTech Dive,
    • “Embecta received 510(k) clearance from the Food and Drug Administration on Friday for its first insulin patch pump.
    • “The device can be used by people with Type 1 or Type 2 diabetes and worn for up to three days. It includes a 300-unit insulin reservoir so that people with higher daily insulin needs can wear it for all three days.
    • “Embecta said Tuesday it plans to develop a closed-loop version of the pump for automated insulin dosing that it will submit to the FDA in the future.”

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.”