Monday Report

Telehealth

Monday Report

David Ermer–ACA, CDC, CMS, Congress, FDA, HSA, Medical / Rx research, Obesity, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Hill reports,
    • “Top Republicans are signaling progress in government funding talks as leaders look to clinch a deal ahead of a looming Friday deadline. 
    • “House Appropriations Chair Tom Cole (R-Okla.) told reporters Monday that the “differences are narrowing” between all sides as they try to hash out the last significant funding deal in the divided Congress.
    • “It’s both between the House and the Senate and Republicans and Democrats. So, they’re both institutional differences, and there are partisan differences,” Cole said. But he added “there are a lot fewer of them than there were 24 hours ago.” * * *
    • “Pressed about the status of health care as leaders look to tie up loose ends in the CR, House Majority Leader Steve Scalise (R-La.) said Monday there are “big discussions on all of the remaining items.”
    • “But we’re trying to get it wrapped up,” he said. 
    • “According to a source familiar, a package of key health policies is expected to be attached to the stopgap funding bill. It will likely include a two-year extension of telehealth flexibilities for Medicare, as well as an overhaul of pharmacy benefit managers’ business practices.” 
  • Fierce Healthcare adds,
    • “Pharmacy benefit manager reform is included in a larger-than-anticipated healthcare package, but the PBM lobby is fighting the legislation at the eleventh hour.
    • “Lawmakers appear to have agreed to a lame-duck healthcare package which, in addition to PBM reform, will include key program extensions.
    • “As of last weekend, the package included an increase to the Medicare physician fee schedule of 2.5% for one year, bonuses to alternative payment models and a reauthorization of the SUPPORT Act for dealing with the opioid crisis.
    • “PBM policies will be used as budgetary offsets. The legislation would ban spread pricing in Medicaid, ensure Part D plan sponsors delink PBM fees from the price of a drug and includes other transparency requirements.
    • “The end-of-year health care package accompanying the Continuing Resolution has morphed into a massive 400-page bill that includes provisions that would undermine the role that PBMs play in lowering costs and providing choices for employers in the prescription drug marketplace,” said the PBM trade lobby, the Pharmaceutical Care Management Association (PCMA), in a statement Dec. 16. “The health care provisions included in the latest draft, as reported in the media, risk increasing costs for health plan sponsors, like employers and labor unions, patients, and families, and hiking up premiums for seniors.”
  • One Digital informs us that “Congress passed the Paperwork Reduction Act and the Employer Reporting Improvement Act, each of which modify the ACA’s provisions on 1094 and 1095 tax form reporting. President Biden is expected to sign both acts into law, significantly altering ACA reporting requirements.”
    • “The Paperwork Reduction Act amends the ACA by no longer requiring employers and health insurance providers to send tax forms to the covered individuals under their health plan. Previously employers and/or insurance providers had to send 1095-B/1095-C tax form to each covered individual showing proof of minimum essential coverage. Now, those forms must only be sent when requested by the covered individual. If a covered individual requests a form, the form must be provided by January 31 or 30 days after the date of the request, whichever is later. Employers and insurance providers must inform covered individuals of their right to request a form.”
    • “The Employer Reporting Improvement Act codifies IRS regulations that allow for an individual’s date of birth to be substituted if the individual’s Tax Identification Number is not available. The Act also amends the ACA to incorporate IRS regulations allowing employers and insurance providers to offer 1095-B and 1095-C tax forms to individuals electronically.
    • Additionally, and more importantly to employers, the Act requires the IRS to give large employers at least 90 days to respond to 226-J letters that issue a proposed employer shared responsibility payment. Previously, employers had only 30 days to respond. Finally, the Act establishes a six-year statute of limitations for collecting these payments.”
       
  • The Plan Sponsor Council of America tells us,
    • “The ERISA Advisory Council (EAC) voted on and approved 12 recommendations for the Department of Labor (DOL) to improve health insurance claim denials and related appeals. These reforms range from better oversight of AI determinations to requiring payouts for prior approvals.
    • “Lisa Gomez, head of the Employee Benefit Security Administration (EBSA), described these proposed reforms today as “strangely and somewhat tragically timely, with the events of last week,” in reference to the killing of UnitedHealthcare CEO Brian Thompson in Manhattan on Dec. 4.”
    • Due to the Affordable Care Act, ERISA appeal procedure changes embedded in regulations typically apply to FEHB carriers.
  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services Dec. 16 published a final rule implementing certain provisions related to information blocking exceptions. The rule revises defined terms related to protecting access to care for purposes of the information blocking regulations.
    • “The agency adopted select provisions first proposed in August as part of the much larger Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) rule. The adopted provisions are designed to address concerns from patients, health care providers and other stakeholders regarding patient privacy, access to care, preferences for electronic health information sharing, and methods for achieving a balance between certainty and flexibility for entities involved in enhancing EHI interoperability and exchange.
    • “The finalized “Protecting Care Access Exception” would allow entities to restrict EHI sharing under certain conditions to mitigate the risk of legal repercussions for patients, providers or care facilitators involved in lawful reproductive health services. The provisions will be effective immediately when published Dec. 17 in the Federal Register.
    • “This is the second rule in less than a week containing policies originally included in the proposed HTI-2 rule. As such, additional provisions of the HTI-2 rule, including prior authorization application programming interfaces, United States Core Data for Interoperability Version 4 standards and public health interoperability requirements — which are currently under review by the White House Office of Management and Budget — could be published soon.”
  • and
    • “The Centers for Medicare & Medicaid Services Dec. 15 announced an extension to Dec. 18 for enrollment in federally facilitated marketplace coverage that begins Jan. 1. This applies to the 31 states that use HealthCare.gov for signups. Those consumers previously had until Dec. 15 to enroll for a full year of coverage. Individuals who enroll for 2025 coverage after Dec. 18 will have their plans begin Feb. 1. Individuals in Washington, D.C., and the 19 states that operate their own state-based marketplaces are advised to visit their state website for deadlines and effective dates for their coverage.”
  • and
    • “The Health Resources and Services Administration last week directed Sanofi to cease implementation of its 340B rebate proposal immediately and to inform HRSA of its plans no later than Dec. 20 in order to provide adequate notice to covered entities.
    • “By way of this correspondence, HRSA provides warning that this unapproved credit proposal violates Sanofi’s obligations under the 340B statute, and HRSA expects Sanofi to cease implementation of it,” wrote HRSA Administrator Carole Johnson.
    • “The letter says that the proposal, if implemented, would violate Sanofi’s obligations under the 340B statute and subject Sanofi to potential consequences, such as termination of Sanofi’s Pharmaceutical Pricing Agreement and civil monetary penalties.
    • “In its Nov. 22 letter to 340B covered entities, Sanofi said it would be effectuating 340B discounts via the new credit model as of Jan. 6, 2025, for disproportionate share hospitals, critical access hospitals, rural referral centers and sole community hospitals.”
  • Govexec points out,
    • “The Office of Personnel Management is set to publish a final rule Tuesday that would finally implement provisions of a seven-year-old law aimed at reducing agencies’ ability to put federal workers accused of misconduct on prolonged stints of administrative leave.
    • “In 2016, Congress enacted the Administrative Leave Act as part of the 2017 National Defense Authorization Act. The law tries to reduce agencies’ reliance on placing federal workers who are under investigation into employment limbo—paid but unable to work—for long stretches of time. It also updated the government’s policies on weather and safety leave.
    • “Though OPM proposed regulations to implement all of the law’s provisions in 2017, only the provisions governing weather and safety leave actually made it across the finish line. But earlier this year, the environmental advocacy group Public Employees for Environmental Responsibility sued the HR agency seeking to force it to act.
    • “In a final rule set for publication Tuesday in the Federal Register, OPM formally implemented the 2016 law’s restrictions on administrative leave. While the new rule will be effective Jan. 17, 2025, agencies have until October to comply with the new restrictions on administrative leave.”

In Food and Drug Administration news,

  • MedTech Dive relates
    • Zimmer Biomet received Food and Drug Administration clearance for a new stemless shoulder implant, called Osseofit.
    • The implant is shaped to match the anatomy of patients’ humerus, or upper shoulder bone, while preserving as much of their healthy bone as possible in total shoulder replacement procedures. Zimmer announced the clearance on Friday.
    • CEO Ivan Tornos highlighted stemless shoulder implants as a meaningful growth driver for the orthopedics company in an Oct. 30 investor call.
  • Per Fierce Pharma
    • “The FDA has blessed two previously approved medicines—one a cream and the other an injection—to treat atopic dermatitis (AD). Both products now will be available to a significantly larger patient population as roughly 26 million in the U.S. have the disorder, which is also known as eczema.
    • “Organon’s Vtama, a topical cream originally approved for plaque psoriasis in 2022, is now cleared to treat AD, the company said early Monday. The nod came three months after New Jersey-based Organon acquired the product in a $1.2 billion takeover of Dermavant. 
    • “Similarly, the FDA gave a thumbs-up to Galderma’s Nemluvio to treat AD. The drug, a monthly subcutaneous injection, was previously endorsed by the U.S. regulator for prurigo nodularis.” 
  • and
    • “After seven decades with no advances in the treatment of the genetic disorder classic congenital adrenal hyperplasia (CAH), Neurocrine Biosciences has scored FDA approval for its first-in-class, twice-daily oral medicine Crenessity (crinecerfont).
    • “The blessing came nearly two weeks before its FDA target date and is termed as “paradigm shifting” by the San Diego-based company. The selective oral corticotropin-releasing factor type 1 receptor (CRF) antagonist can be used by CAH patients ages 4 and older.
    • “Serving as an add-on to glucocorticoid replacement therapies, Crenessity reduces excess adrenocorticotropic hormone (ACTH) and downstream adrenal androgen production, allowing for glucocorticoid dose reduction.”
  • Cardiovascular Business alerts us,
    • “The U.S. Food and Drug Administration (FDA) and Boston Scientific today sent an urgent alert to patients and healthcare providers about the potential need for early device replacement of some Accolade pacemakers.
    • The company announced a recall for a subset of its Accolade devices because of an increased risk of permanently entering the safety mode. This has limited functionality, making the device unable to properly regulate the heart’s rhythm and rate. Most of the activations have occurred during follow-up office or hospital visits when the devices are interrogated for data.
    • There have been two reported patient deaths in pacemaker dependent patients after the devices went into safety mode in an ambulatory outpatient medical setting. Boston Scientific said about 70% of safety mode events occurred during in-office interrogations from a Latitude programmer, and the remaining incidents took place in an ambulatory setting.
    • “The risk of harm may be greater when safety mode occurs in an ambulatory setting, as patients are not in a monitored clinical environment,” the company said in its recall notice.
  • Beckers Hospital Review adds,
    • “The FDA has recalled more than 233,000 bottles of antidepressant duloxetine, sold by Rising Pharmaceuticals, due to a potential cancer risk. 
    • “The recall, issued Dec. 5, was prompted by the discovery of a nitrosamine impurity, N-nitroso-duloxetine in the capsules which exceeds the FDA’s safety threshold. 
    • ‘The FDA has classified the recall as a Class II risk, its second most severe classification. The recall affects 233,000 bottles of duloxetine, which is used to treat conditions such as depression and generalized anxiety disorder. 
    • “The FDA also recalled 7,107 bottles of duloxetine capsules distributed by Towa Pharmaceutical Europe in October for similar concerns about nitrosamine impurities.” 

From the public health and medical research front,

  • MedPage Today reports,
    • “CDC could not confirm what was suspected to have been the first H5N1 bird flu case linked to raw milk.
    • “The patient, a child in Marin County, California, experienced fever and vomiting after drinking raw milk, as reported last week. The child initially tested positive for influenza A, with the local lab unable to find evidence of person-to person transmission between the child and her family members.
    • “The State Laboratory and the CDC conducted additional testing, “but due to low levels of viral RNA, they were unable to confirm whether the influenza A virus present was H5N1 (avian influenza) or seasonal influenza,” according to the Marin County public health department.”
  • The Washington Post tells us,
    • “Nearly a quarter of U.S. adults reported living with chronic pain in 2023, according to a recent report from the Centers for Disease Control and Prevention.
    • “Just over 24 percent (24.3 percent) of survey respondents said they experienced chronic pain either most days or every day, the CDC said, and nearly 9 percent of adults had “high-impact chronic pain” in the previous three months, meaning their pain frequently limited their life or work activities.” * * *
    • “Chronic pain and pain that often restricts life or work activities, referred to in this report as high-impact chronic pain are the most common reasons adults seek medical care, and are associated with decreased quality of life, opioid misuse, increased anxiety and depression, and unmet mental health needs,” co-authors Jacqueline W. Lucas and Inderbir Sohi wrote in a data brief on the numbers.”
  • Beckers Hospital Review adds,
    • “In 2023, the United States saw a slight decrease in obesity prevalence among adults, according to research findings published Dec. 13 in JAMA. 
    • “Amid projections of increasing obesity rates over the next decade, researchers from Boston Children’s Hospital and Optum Life Sciences analyzed body mass index data from 2013 to 2023. The dataset included nearly 48 million BMI measurements from 16.7 million nonpregnant adults. 
    • “Between 2013 and 2022, mean population BMI and obesity rates rose annually. Both figures slightly declined in 2023, the study found. 
    • “The researchers suggested this change could be due to weight loss GLP-1s such as semaglutide (Wegovy) and “pandemic-associated demographic and behavior changes.”
  • A recent National Health Statistics Reports shares characteristics of older Americans who fulfilled physical activity guidelines in 2022.
  • The American Medical Association lets us know what doctors wish their patients knew about hand, foot, and mouth disease.
  • MedPage Today notes,
    • “Diets higher in inflammatory foods were tied to an increased incidence of dementia in older adults, longitudinal data from the Framingham Heart Study Offspring cohort showed.
    • “Over 13 years of follow-up, higher Dietary Inflammatory Index (DII) scores averaged across three time points were linearly associated with an increased incidence of all-cause dementia (HR 1.21, 95% CI 1.10-1.33, P<0.001), reported Debora Melo van Lent, PhD, of UT Health San Antonio in Texas, and co-authors.
    • “Similarly, higher DII scores were linearly associated with an increase in Alzheimer’s disease dementia (HR 1.20, 95% CI 1.07-1.34, P=0.002), the researchers reported in Alzheimer’s & Dementia. Findings were adjusted for demographic, lifestyle, and clinical covariates.
    • “Although these promising findings need to be replicated and further validated, our results suggest that diets that correlate with low DII scores may prevent late-life dementia,” van Lent and colleagues noted.”
  • To that end, Consumer Reports, writing in the Washington Post, discusses “four ways to reduce inflammation for better health. It’s thought to be an underlying cause of diabetes, heart disease and more. Diet and lifestyle can help you control it.”
  • Per a press release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness of tabelecleucel (“tab-cel”®, Pierre Fabre) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).
    • “ICER’s report on this therapy was the subject of the November 2024 public meeting of the New England CEPAC, one of ICER’s three independent evidence appraisal committees. 
    • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations 
  • STAT News reports,
    • “Just over a year ago the PREVENT calculator to predict cardiovascular risk was released by the American Heart Association. It was acclaimed for improving on a 2013 model that didn’t take into account companion conditions such as kidney disease or type 2 diabetes, or include people from more diverse backgrounds.
    • “PREVENT soon drew attention for its potential to reduce the number of Americans eligible to receive widely prescribed cholesterol-lowering statins, projected in two analyses published in June and July. 
    • “A less noted change was the addition of heart failure to conditions estimated by the risk calculator, alongside the traditional targets of heart attack and stroke. Heart failure is a serious illness that means the heart can no longer pump blood through the body as well as it should. It’s different from diseases that narrow blood vessels that feed the heart or brain.
    • “Heart failure has no cure, making it more urgent to identify who’s at risk. PREVENT allows that risk to be estimated using information typically collected in a regular primary care visit.”

From the U.S. healthcare business front,

  • Reuters reports,
    • “Powerful weight-loss drugs are expanding use of U.S. health care as patients starting prescriptions are diagnosed with obesity-related conditions or take the drugs to become eligible for other services, health records and discussions with doctors show.
    • “An exclusive analysis of hundreds of thousands of electronic patient records by health data firm Truveta found slight, but measurable, increases in first-time diagnoses of sleep apnea, cardiovascular disease, and type 2 diabetes within 15 days of an initial prescription for a GLP-1 weight-loss drug between 2020 and 2024.
    • “In addition to obesity-related conditions, some patients are being prescribed the drugs to lose weight and become eligible for services, including organ transplants, fertility treatments or knee replacements, according to interviews with seven doctors and five other health experts.
    • “This is a population that previously felt stigmatized by health care providers and often didn’t return. But now that they’re actually seeing themselves get healthier, asking clinicians questions and engaging more, I do think we’re seeing new patients,” said Dr. Rekha Kumar, a New York endocrinologist and obesity medicine specialist.”
  • McKinsey and Company explore how the healthcare industry can weather current challenges.
    • “The healthcare industry has been buffeted by a growing number of challenges over the past few years. This turbulence struck provider organizations in 2022, while payers were initially sheltered from the storm (Exhibit 1). But conditions became more difficult for payers in 2023, which has continued into this year, and there’s limited respite on the horizon. Unlike the widespread challenges the provider and payer sectors have faced, the picture for pharmacy services has been more nuanced. Some organizations have been propelled by tailwinds from pharmaceutical innovation and new delivery models, while others have battled headwinds from increased regulatory scrutiny. The healthcare services and technology (HST) sector, in contrast, has benefited from continued demand for data, analytics, and software. Along with pressures on earnings, the healthcare sector has also faced challenges in the capital markets, with deal activity in 2024 lower than 2023, according to McKinsey analysis.”
  • Per the American Hospital Association News,
  • Healthcare IT News tells us “74% of hospital leaders say virtual nursing will become integral to acute care. A nurse expert [in the article] discusses the results of a new survey from AvaSure showing that, while virtual nursing has yet to gain traction in acute inpatient care, it holds much promise – and already is showing results that benefit both nurses and the bottom line.”
  • A recent National Health Statistics Report examines under age 65 enrollment in high deductible and consumer driven health plans in the U.S.
  • Per HR Brew,
    • “Despite a softening job market, US employers are expected to grant merit increases of 3.3% to non-unionized employees in 2025—the same rate as this year, according to a report by Mercer.
    • “It’s not surprising to us to see employers really kind of keeping up with the part of what they had done in the prior year,” said Jack Jones, principal consultant at Mercer. “I think what it shows is employers are still prioritizing the investment in their talent.”
    • “Next year, employers are expected to increase their total salary budgets—which includes money for promotions and adjustments to reach equity—to 3.7%, excluding unionized workers. The increase was 3.6% for this year. About one-tenth (9.3%) of employees are expected to receive promotions next year, compared to 8% in 2024.
    • “However, Jones noted the numbers could change because only 20% of the more than 850 organizations surveyed had finalized their budgets. Still, most organizations (69%) don’t expect to adjust their initial projections.”

Thursday Report

David Ermer–ACA, CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, OPM, Telehealth, U.S. Healthcare–

Healthcare Dive shares observations and news about yesterday’s murder of United Healthcare’s CEO Brian Thompson.

Yahoo News delves into the investigation of Mr. Thompson murder by the New York City Police Department. The FEHBlog has the utmost confidence that this investigation will end with at least one arrest.

From Washington, DC

  • Federal News Network informs us,
    • “Enrollees in the new Postal Service Health Benefits program will have a few extra days of Open Season to review their plan options and make changes to their benefits for plan year 2025.
    • “The Office of Personnel Management officially extended Open Season for PSHB participants until Dec. 13, Federal News Network has learned. Participants in the Federal Employees Health Benefits program and other federal benefits programs will still see Open Season end on the original Dec. 9 deadline.
    • “OPM said the transition to the new PSHB program is “a big change” for enrollees, and it’s extending Open Season by four days to give Postal employees, annuitants and their family members additional time to look at plans and make changes as they see fit.
    • “We feel it is important to extend Open Season for customers of the PSHB program to give them ample time to shop for plans and change their elections if they want to,” OPM said.
  • Tammy Flanagan, writing in Govexec, discusses Open Season and tax savings.
  • Politico reports,
    • “The House is losing several health policy leaders after this Congress, and they’ll likely want to make their mark in their last two months on Capitol Hill.
    • “While Congress negotiates its end-of-year legislative package, some key departing lawmakers are rallying to pass projects before their terms end — although expectations for a health care package are low. Historically, Congress has sometimes shown a willingness to give outgoing lawmakers a win.”
    • Politico shares the legacy goals of the retiring House members.
  • Among the bills for possible inclusion in the lame duck health care package is S. 1339, Pharmacy Benefit Manager Reform Act. The Congressional Budget Office issued a report on this bill today.
  • The Washington Post informs us,
    • “A bipartisan group of senators grilled Food and Drug Administration officials Thursday on the agency’s failure to more tightly regulate ultra-processed foods and food dyes, highlighting a key part of the health agenda promoted by Robert F. Kennedy Jr.
    • “Kennedy, President-elect Donald Trump’s controversial pick to lead the sprawling Department of Health and Human Services, which oversees the FDA, has blamed the nation’s surge of chronic disease and declining life expectancy on ultra-processed foods — a position that aligns with Sen. Bernie Sanders (I-Vermont), who convened the hearing as chairman of the Senate health committee.
    • “Congress and the FDA have allowed large corporations to make huge profits by enticing children and adults to consume ultra-processed food and beverages loaded up with sugar, salt and saturated fat,” Sanders said Thursday, pointing to the billions of dollars the food-and-beverage industry spends on advertising.”
  • Govexec notes,
    • “The leaders of President-elect Trump’s new advisory panel aiming to slash government spending, Elon Musk and Vivek Ramaswamy, met with Republican lawmakers at the Capitol on Thursday in what leaders pitched as an informational session to share ideas. 
    • “Congressional Republicans and a handful of Democrats have embraced Trump’s Department of Government Efficiency, which will function as a non-governmental commission, and on Thursday were eager to share their ideas for identifying areas for cuts. Some Republicans cautioned, however, that the advisory panel must work through the appropriate channels and win congressional support for their initiatives. 
    • “Nearly every House and Senate member that emerged from the various meetings called them productive and suggested a unifying idea supported by both lawmakers and Trump’s designated efficiency czars: recalling teleworking employees back to the office.”  
  • Per Department of Health and Human Services press releases,
  • and
    • “Today, the U.S. Department of Health & Human Services (HHS), Office for Civil Rights (OCR), issued a “Dear Colleague” letter – PDF to help federally funded health care providers, plan grantees, and others better understand their civil rights obligations under the new final rule on Section 1557 of the Affordable Care Act (“Section 1557”).  
    • “Section 1557 provides nondiscrimination protections by requiring covered entities (e.g., recipients of Federal financial assistance, programs administered by HHS, and entities established under Title I of the Affordable Care Act (ACA)) to provide language assistance to individuals with limited English proficiency (LEP) or disability.”
  • Modern Healthcare reports,
    • “Hospitals have expanded their legal push for the federal government to boost Medicare reimbursement.
    • “More than 500 hospitals last week sued the Health and Human Services Department for allegedly miscalculating a 40-year-old Inpatient Prospective Payment System base reimbursement rate that providers say has lowered years of subsequent Medicare payments to hospitals. The lawsuit is the latest in a series of similar complaints that allege the Health and Human Services Department must increase Medicare inpatient pay.
    • “Each lawsuit challenges different batches of denied requests to amend reimbursement rates, but the arguments are largely the same. Hundreds of millions of dollars are at stake, providers allege. If the federal government changes the inpatient base pay rate, hospitals stand to not only recoup money from prior fiscal years but also increase future reimbursement rates.”
  • The American Hospital Association News tells us,
    • “A $2.8 billion settlement from Blue Cross Blue Shield to health care providers resolving a 12-year antitrust lawsuit received preliminary approval yesterday from the U.S. District Court for the Northern District of Alabama. The settlement will also “significantly improve how Providers will interact with the Blues, bringing more transparency and efficiency to their dealings, and increase Blue Plan accountability,” according to the court filing. 
    • “The lawsuit alleged that BCBS member companies violated antitrust laws by agreeing to allocate markets via exclusive service areas and fixing prices paid to health care providers through the organization’s BlueCard Program.”
  • and
    • “Approximately 988,000 consumers who currently do not have health insurance coverage through the individual marketplace have signed up for a 2025 health plan through the federally facilitated Health Insurance Marketplace, the Centers for Medicare & Medicaid Services announced yesterday. Nearly 4.4 million returning consumers have selected 2025 plans. The open enrollment period began Nov. 1 and continues through Jan. 15.”
    • The deadline for January 1, 2025, enrollments is December 15, 2024. Later enrollments will begin on February 1, 2025.
  • and
    • “The Food and Drug Administration yesterday released recommendations for streamlining the approval process for medical devices that use artificial intelligence. The guidance recommends information to include in a predetermined change control plan as part of a marketing submission for a medical device using AI. The PCCP should include a description of the device’s planned modifications; methods to develop, validate and implement the modifications; and an assessment of the modification’s impacts. FDA will then review the PCCP within the submission to ensure the device’s safety and effectiveness without needing additional marketing submissions for each modification.” 

From the public health and medical research front,

  • The Washington Post reports,
    • “Scientists from the Scripps Research Institute are reporting that it would take just a single mutation in the version of bird flu that has swept through U.S. dairy herds to produce a virus adept at latching on to human cells, a much simpler step than previously imagined.
    • “To date, there have been no documented cases of one human passing avian influenza to another, the Scripps scientists wrote in their paper, which was published Thursday in the journal Science. The mutation they identified would allow the virus to attach to our cells by hitching itself to a protein on their surface, known as the receptor.
    • “William Schaffner, a professor of infectious diseases at Vanderbilt University Medical Center who did not participate in the study, called the research “sobering,” adding, “I had not known it would take just one mutation in the virus for it to attach itself to the receptors on human cells.
    • “However, he stressed that the H5N1 virus has been active for 20 years and “has multiplied billions upon billions upon billions of times and the spontaneous mutation that the authors describe,” has not been found, despite intense surveillance.
    • “Yoshihiro Kawaoka, a professor of virology at the University of Wisconsin, who was not involved in the latest research but has studied bird flu extensively, said that statistically, the mutation probably already exists in H5N1-infected cows and humans, given that 1 in 10,000 infectious particles of the influenza virus is a mutant.
    • “James C. Paulson, one of the paper’s authors, and several other top scientists agreed that it is statistically likely the mutation has occurred in the H5N1 virus but stressed that it has yet to be detected, and other barriers remain before the virus could be transmitted from one person to another. Paulson is a professor in the Department of Molecular Medicine at Scripps.”
  • The National Institutes of Health Director, Dr. Monica Bertagnolli, writes in her blog,
    • “Your memories of life experiences are encoded in collections of neurons in the brain that were active at the time the event took place. Later, those same patterns of neural activity are replayed in your mind to help stabilize your memories of past events. But new research suggests those memories aren’t fixed. An NIH-supported study in male mice reveals how an older memory can be “refreshed” and altered by association with newer events.
    • “The findings, reported in Nature , show that a memory of a recent negative event can become linked to the memory of a neutral event that took place days earlier, changing the way it’s remembered. This provides important insight into what we know about how the brain updates and reorganizes memories based on new information. These findings could also have implications for our understanding of neurobiological processes that might occur in the brain in memory-related mental health conditions like post-traumatic stress disorder (PTSD), when people feel stress or fear even in situations that present no danger.” *. * *
    • “Although these findings were obtained in a mouse model, according to the researchers, the study results suggest that our brains may integrate memories to form a cohesive understanding of real-world experiences in ways that offer stability and flexibility. These insights suggest that memories of the past are constantly updated and refreshed by new experiences in ways that may help us function in a world marked by constant change.
    • “The findings also suggest that negative experiences can lead us to fear seemingly unrelated places or events in ways that are detrimental. This may help to explain why for people with PTSD, exposure therapy—in which people work to overcome fears through gradual exposures to them in a safe environment—can stop being effective. The hope is that findings like these might shed light on potential new ways to treat PTSD and related disorders.”
  • Per an NIH press release,
    • “Improvements in cancer prevention and screening have averted more deaths from five cancer types combined over the past 45 years than treatment advances, according to a modeling study led by researchers at the National Institutes of Health (NIH). The study, published Dec. 5, 2024, in JAMA Oncology, looked at deaths from breast, cervical, colorectal, lung, and prostate cancer that were averted by the combination of prevention, screening, and treatment advances. The researchers focused on these five cancers because they are among the most common causes of cancer deaths and strategies exist for their prevention, early detection, and/or treatment. In recent years, these five cancers have made up nearly half of all new cancer diagnoses and deaths.
    • “Although many people may believe that treatment advances are the major driver of reductions in mortality from these five cancers combined, the surprise here is how much prevention and screening contribute to reductions in mortality,” said co-lead investigator Katrina A. B. Goddard, Ph.D., director of NCI’s Division of Cancer Control and Population Sciences. “Eight out of 10 deaths from these five cancers that were averted over the past 45 years were due to advances in prevention and screening.”
    • “A single prevention intervention, smoking cessation, contributed the lion’s share of the deaths averted: 3.45 million from lung cancer alone. When considering each cancer site individually, prevention and screening accounted for most deaths averted for cervical, colorectal, lung, and prostate cancer, whereas treatment advances accounted for most deaths averted from breast cancer.
    • “To reduce cancer death rates, it’s critical that we combine effective strategies in prevention and screening with advances in treatment,” said W. Kimryn Rathmell, M.D., Ph.D., director of NCI. “This study will help us understand which strategies have been most effective in reducing cancer deaths so that we can continue building on this momentum and hopefully increase the use of these strategies across the United States.”
  • The AP adds,
    • “Many moms-to-be opt for blood tests during pregnancy to check for fetal disorders such as Down syndrome. In rare instances, these tests can reveal something unexpected — hints of a hidden cancer in the woman.
    • “In a study of 107 pregnant women whose test results were unusual, 52 were ultimately diagnosed with cancer. Most of them were treated and are now in remission, although seven with advanced cancers died.
    • “They looked like healthy, young women and they reported themselves as being healthy,” said Dr. Diana Bianchi, the senior author of the government study published Wednesday in the New England Journal of Medicine.
    • “Of the discovered cancers, lymphoma blood cancers were the most common, followed by colon and breast cancers.
    • “The blood test is called cell-free DNA sequencing. It looks for fetal problems in DNA fragments shed from the placenta into the mother’s bloodstream. It also can pick up DNA fragments shed by cancer cells.”
  • NBC News relates,
    • “Prescription fills for blockbuster weight loss medications in the U.S. more than doubled in 2024, even with limited insurance coverage and high out-of-pocket costs for the treatments.
    • “That’s according to new data from drug savings company GoodRx, which examined fill trends and spending patterns for weight loss drugs such as Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound.
    • “It offers more evidence of the insatiable demand for a buzzy class of medications called GLP-1 and GIP agonists, which have hefty list prices of roughly $1,000 per month before insurance or savings cards.”
  • More on prevention from Physicians’ Weekly,
    • “People with type 2 diabetes mellitus (T2DM) face a high risk of cardiovascular disease (CVD), but the timing of this elevated risk before diagnosis is not well understood.  
    • “Researchers conducted a retrospective study to examine CVD occurrence up to 30 years before and 5 years after a diagnosis of type 2 diabetes.  
    • ‘They included individuals diagnosed with type 2 diabetes in Denmark (2010 and 2015) n=127,092 and matched comparisons n=381,023. Conditional logistic regression was used to compute ORs for the prevalence of CVD in the 30 years before diagnosis, and Cox proportional hazards regression models to calculate HRs for 5-year CVD incidence after diagnosis.  
    • ‘The results showed that, in the 30 years before diagnosis, 14,179 (11.2%) individuals with type 2 diabetes and 17,871 (4.7%) comparisons experienced CVD. The odds of CVD were higher for individuals with type 2 diabetes, ranging from 2.18 (95% CI: 1.91-2.48) in the earliest period (25-30 years before diagnosis) to 2.96 (95% CI: 2.85-3.08) in the latest period (less than 5 years before diagnosis). After diagnosis, the 5-year CVD incidence was higher for individuals with type 2 diabetes (HR: 2.20; 95% CI: 2.12-2.27).  
    • “They concluded that individuals with type 2 diabetes experienced twice the number of CVD events compared to matched controls, starting up to 30 years before diagnosis, suggesting that early preventive strategies may be necessary.”  

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly said it would invest $3 billion to expand a recently acquired manufacturing facility to meet growing demand for its diabetes and weight-loss medicines.
    • “The drugmaker said the Kenosha County, Wis., plant expansion would extend the reach of its injectable-product manufacturing and add 750 jobs. The facility already employs around 100 people.
    • “Overall, the expanded facility would focus on manufacturing injectable medicines, device assembly and packaging for medicines across multiple therapeutic areas, the Indianapolis company said.
    • “The decision comes months after Lilly resolved shortages for its weight-loss and diabetes drugs, Zepbound and Mounjaro. Lilly’s rival, Novo Nordisk, has been expanding its production capacity to resolve shortages.”
  • Per Fierce Healthcare,
    • “Amazon has added digital musculoskeletal care company Hinge Health to its health conditions program, a service it rolled out in January to help connect customers with virtual care benefits.
    • “Hinge Health is the first digital musclosketal platform to join Amazon Health Services’ offering that aims to help people discover and enroll in digital health programs available through their employer or health plan at no additional cost.
    • “It marks the fourth company to join Amazon Health Services’ digital health benefits program, following Omada Health, as its first launch partner, Talkspace and behavioral health company Rula Health.”
  • Per Fierce Pharma,
    • “AstraZeneca has picked off another label expansion for its cancer blockbuster Imfinzi (durvalumab) as the FDA has blessed the PD-L1 inhibitor for limited-stage small cell lung cancer (LS-SCLC) patients who have not had disease progression after concurrent chemotherapy and radiation treatments.
    • “With the nod, Imfinzi becomes the first immunotherapy for LS-SCLC, an aggressive form of the disorder with a survival rate between 15% and 30% after diagnosis. The subtype includes roughly 30% of all SCLC cases. It often recurs and progresses rapidly despite initial response to standard-of-care chemo and radiation treatment.
    • “The approval is backed by results from the ADRIATIC trial which showed that, compared to placebo, Imfinzi extended patients’ lives by 27% among those who had not progressed following chemoradiotherapy. The estimated median overall survival was 55.9 months for Imfinzi versus 33.4 months for placebo.”
  • BioPharma Dive points out,
    • “Inside every human cell are thousands of snippets of genetic code that serve as the directions for creating proteins. And over the past four years, a small biotechnology company has been trying to prove that, by looking closely enough at this assembly of instructions, it can find new ways to treat diseases like Alzheimer’s, Parkinson’s and multiple sclerosis.
    • “The company, Muna Therapeutics, now has a nod of confidence from one of the world’s largest drugmakers, as it announced on Thursday a collaboration with GSK that could ultimately be worth hundreds of millions of dollars.
    • “Per deal terms, Muna will analyze brain tissue samples from a variety of sources, from healthy individuals to Alzheimer’s patients to centenarians with and without cognitive impairment. The company will then use different technologies to determine where protein instructions are (or aren’t) in those tissues, with the goal being to identify and validate new targets for Alzheimer’s drugs.”
  • RAND Healthcare shares its key findings on telehealth policy.

Monday Roundup

David Ermer–CDC, CMS, FDA, Medical / Rx research, SCOTUS, Telehealth, U.S. Healthcare–

From Washington, DC,

Photo by Sven Read on Unsplash
  • Govexec tells us,
    • “The U.S. Postal Service said it is well positioned to handle a blitz of mail and packages ahead of the holiday season, though it will confront its busiest time of the year after once again hiring fewer seasonal employees. 
    • “USPS will bring on just 7,500 temporary workers to help the agency complete processing and delivery efforts, with employees having started as early as October and staying on as late as mid-January. That is down slightly from its target of 10,000 hires last year and precipitously from 45,000 in 2021. Postal management has maintained that its efforts to convert nearly 200,000 part-time staff to full-time, career employees over the last several years has mitigated its need to onboard seasonal workers. “
  • The American Hospital Association News lets us know,
    • “More than 496,900 consumers who currently do not have health insurance coverage have signed up for a 2025 health plan through the federally facilitated Health Insurance Marketplace, the Centers for Medicare & Medicaid Services reported last week. They join over 2.5 million returning consumers who selected plans for 2025 during the open enrollment period. Open enrollment began Nov. 1 and continues through Jan. 15. Last year, 21.4 million people signed up for coverage.” 
  • Per an HHS press release,
    • “The Administration for Strategic Preparedness and Response (ASPR), part of the U.S. Department of Health and Human Services, today announced two additional Defense Product Act (DPA) Title III Active Pharmaceutical Ingredient (API) investments focused on solving ongoing drug shortages. These new investments seek to rebuild and protect the U.S. public health supply chain as an essential part of national defense.” * * *
    • “Under DPA Title III, ASPR’s Office of Industrial Base Management and Supply Chain (IBMSC) will provide $32.4 million to Manus Bio, Inc., a private company in Waltham, Massachusetts, to expand its facilities for the production of key starting materials for essential medicines. Manus will utilize biomanufacturing and incorporate a continuous flow process which enables automated multi-step chemical synthesis. Manus has developed a suite of optimized microbial chassis which gives access to more than 150,000 natural products, known as bioalternatives, including terpenoids, polyketides, phenylpropanoids, and flavonoids.  
    • “ASPR IBSMC also will provide up to $12 million to Antheia, Inc., a private pharmaceutical ingredient manufacturer located in Menlo Park, California. Antheia’s biomanufacturing platform leverages bioengineering and computational biology to produce critical drug substances in an efficient and scalable one-step fermentation process. Antheia will focus on key starting materials and APIs used in the production of essential medicines.”
  • KFF considers “how [a bunch of] pending health-related lawsuits could be impacted by the incoming Trump Administration.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Bird flu, a virus that can also affect humans, has been discovered in a batch of raw milk sold in California store refrigerators, state regulators said Sunday. While there have been no reported illnesses in this most recent case, it comes just a few days after a child tested positive for bird flu for the first time in U.S. history.
    • “A batch of whole raw milk from Raw Farm that has a “best by” date of Nov. 27, 2024, has been recalled after Santa Clara County health officials detected bird flu in a sample purchased for testing, the California Department of Public Health said in a news release. The farm is in Fresno County.
    • “Retailers have been notified to pull the product from their refrigerator racks, the state health department said. Consumers who may have it in their homes are advised not to drink it.”
  • MedPage Today adds,
    • “Last week, it was reported that an infant died from a Listeria infection in an outbreak tied to ready-to-eat-meat products. Meanwhile, recalls continue after an outbreak of Escherichia coli from bagged organic carrots led to 15 hospitalizations and a death.
    • “What seems like a marked rise in reports of foodborne illnesses in recent months may not be an illusion — but experts say the reasons behind a presumed increase may be more related to how we track these outbreaks than the outbreaks themselves.”
  • The American Medical Association explains what doctors wish their patients knew about peripheral artery disease.
  • Consumer Reports, writing in the Washington Post, tells us “Sugar substitutes are everywhere. How safe are they to eat? Manufacturers are responding to growing demand by using non-sugar sweeteners to replace some or all of the sugar in many foods and drinks.”
  • Per STAT News,
    • “Alector Therapeutics said Monday that its Phase 2 trial for an experimental Alzheimer’s antibody failed, dealing a blow to what had been one of the leading dark horse approaches to treating the neurodegenerative disease.
    • “The drug, called AL002, is designed to activate a group of surveilling neuronal immune cells called microglia. It was among several efforts, now in or nearing clinical trials, predicated on the notion that modulating the brain’s immune system could slow the degenerative disease. 
    • “In the 381-person trial, however, patients who received AL002 didn’t decline more slowly than patients who were on placebo, as measured by a scale called the Clinical Dementia Rating Sum of Boxes. Alector said the trial also failed to show an effect on secondary measures of cognition and function, or on biomarkers associated with the disease, such as amyloid levels.”
  • Per Fierce Pharma,
    • “Incyte’s previously disclosed phase 3 win in relapsed or refractory follicular lymphoma (R/R FL) sent the company racing to file an expansion bid for its Monjuvi (tafasitamab) by year-end. Now, a clearer picture of the drug’s success in the patient population has been revealed courtesy of a research paper published ahead of this year’s American Society of Hematology Annual Meeting & Exposition.
    • “In the phase 3 inMIND study, Monjuvi—added to Bristol Myers Squibb’s Revlimid and Roche’s Rituxan—triggered a 57% reduction in the risk of disease progression, relapse or death in R/R FL patients compared with those who were treated with placebo, Revlimid and Rituxan, according to the paper.
    • “Researchers determined a median investigator-assessed progression free survival of 22.4 months for the treatment arm versus 13.9 months for the control group. The benefits in progression-free survival were consistent across subgroups, the researchers said.”
  • and
    • “After a recent failed showing in a breast cancer subgroup raised doubts around AstraZeneca’s Truqap, the first-in-class AKT inhibitor is making inroads in a prostate cancer subtype.
    • “High-level results from the company’s ongoing CAPltello-281 phase 3 study demonstrated that a combination of Truqap, Johnson & Johnson’s Zytiga and androgen deprivation therapy (ADT) delivered statistically significant and clinically meaningful improvements on the trial’s primary endpoint of radiographic progression-free survival (rPFS), AZ said on Monday.
    • “The trial compared the regimen versus the standard-of-care Zytiga and ADT in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC), a specific type of prostate cancer with a particularly poor prognosis, AZ said in its Monday press release.”
  • Per BioPharma Dive,
    • “Adding Merck & Co.’s new cardiovascular drug Winrevair to background therapy helped people with severe lung hypertension stay alive and avoid invasive medical care longer than those who only received background therapy, the company said Monday.
    • “Data from the ZENITH trial could potentially expand use of a drug that’s now forecast to earn $5 billion a year at its peak. A trial steering committee stopped the trial early at an interim checkpoint because data indicated the Winrevair combination clearly outperformed placebo, Merck said.
    • “Merck obtained Winrevair in 2021 with its $11 billion acquisition of Acceleron in 2021. The pharmaceutical company is looking for sales of heart disease drugs to drive growth in coming years as its biggest seller, the cancer treatment Keytruda, loses market exclusivity later in the decade.”
  • and
    • “An experimental, muscle-preserving drug from Biohaven fell short of its goal in a Phase 3 study of people with spinal muscular atrophy, but showed enough promise in its effects on body composition that the company plans to advance it as a treatment for obesity.
    • “A regimen of Biohaven’s drug, taldefgrobep alfa, and a standard SMA therapy didn’t significantly improve motor function after 48 weeks compared to treatment with a typical SMA medicine and placebo. Biohaven didn’t provide full study data in a Monday statement, but claimed it found “efficacy signals” in certain subgroups and plans to discuss potential paths forward in SMA with U.S. regulators.
    • “Treatment was associated with positive changes on body composition, Biohaven said. The “overall strength and consistency” of those findings has encouraged the company to “rapidly advance” the drug into a placebo-controlled Phase 2 trial in obesity by the end of the year.”

From the U.S. healthcare business front,

  • The Washington Post discusses at length hospital and emergency care at home programs.
  • Fierce Pharma informs us,
    • “After six straight quarters in which Eli Lilly or Novo Nordisk achieved the highest year-over-year revenue growth among the top companies in the biopharma industry, there was a new champion in the third quarter—and it was a major surprise.
    • “With a 32% increase in sales, Pfizer delivered the No. 1 bump among large drugmakers in the period, topping the sales growth figures for Novo (21%) and reigning champion Lilly (20%).
    • Pfizer’s performance came during a remarkable quarter of revenue growth for the industry. Of the industry’s top 20 companies by sales, nine posted double-digit increases and just three saw declines. This contrasts, for example, to the first quarter of 2023, when Novo at 27% was the only company with a double-digit increase in sales and was among only six of the top 20 drugmakers that had a year-over-year (YOY) revenue boost.”
  • Beckers Hospital Review warns that 705 rural hospitals are at risk of closure and discusses the ongoing legal battle between GLP-1 drugmakers and compound pharmacies.
  • MedCity News interviews Nworah Ayogu, head of healthcare impact at Thrive Capital, who suggests three mindset shifts that providers should adopt in order to succeed at consumer driven care.
  • Modern Healthcare reports,
    • “Mount Sinai Health System has opened a $100 million building dedicated to artificial intelligence.
    • “The Hamilton and Amabel James Center for Artificial Intelligence and Human Health is dedicated to the research and development of AI tools that can be used across the eight-hospital system, Mt. Sinai said Monday.
    • “The facility is housed in a 65,000-square-foot building on New York City’s Upper East Side near the system’s main campus. It will centralize Mount Sinai’s AI efforts in genomics, imaging, pathology, electronic health records and clinical care.”
  • MedTech Dive relates,
    • “Boston Scientific said Monday it has agreed to acquire Intera Oncology, which makes treatments for liver tumors primarily caused by metastatic colorectal cancer.
    • “Newton, Massachusetts-based Intera developed the Intera 3000 hepatic artery infusion (HAI) pump and chemotherapy drug floxuridine, both of which are approved by the Food and Drug Administration.
    • “The companies did not disclose the terms of the deal. Boston Scientific expects the acquisition to close in the first half of 2025, subject to closing conditions.”
  • Per Fierce Healthcare,
    • “Teladoc Health launched an artificial-intelligence-enabled technology that allows hospital staff to virtually detect when a patient is at risk of falling from a hospital bed. The solution, unveiled Monday and called Virtual Sitter, is now commercially available.
    • “Hospitalized patients may be at risk of falling from their hospital beds for innocuous reasons, such as needing to use the bathroom, leaning to get a cup of water or to reach a phone and contact family. Nearly 1 million hospitalized patients experience falls each year, and 30% result in lasting injuries, Teladoc Health cited in a press release.
    • “The Virtual Sitter uses AI to detect when a patient performs a movement that puts them at risk of falling. Using computer vision, the Virtual Sitter technology detects when the patient moves beyond set spatial boundaries. Teladoc’s advanced AI can distinguish the patient from other people in the room, can determine whether the patient is sitting up or lying down to determine risky movements, and tracks limb movements.
    • “On the other end of the Virtual Sitter is a hospital-trained, nonclinical staff person who can safely monitor up to 25% more patients with the technology. The AI movement detection alerts the remote staff member when a patient crosses the boundaries of the Bounding Box or moves in a risky fashion.”

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, HSA, Medical / Rx research, Mental health care, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The Washington Post reports,
    • “In a flurry of Friday night announcements, President-elect Donald Trump said he had selected Scott Bessent, a financier who embraced MAGA, to head the Treasury Department; Russell Vought, a Project 2025 contributor, to run the White House budget office again; and Rep. Lori Chavez-DeRemer (R-Oregon) [who lost her bid for re-election] for labor secretary. The president-elect also said he had selected Janette Nesheiwat, a Fox News contributor, to serve as surgeon general; and former congressman Dave Weldon to head the Centers for Disease Control and Prevention.”
  • The HHS, Labor, and Treasury Secretaries are the principal Affordable Care Act regulators while the Office for Management and Budget carriers a lot of weight with the Office of Personnel Mangement.
  • The American Hospital Association News tells us,
    • “The AHA and 22 other organizations Nov. 22 urged Congress to pass an end-of-year health care package that includes action on alternative payment models and a scheduled physician payment cut. The organizations requested an extension of Medicare’s Advanced Alternative Payment Model incentive payments, ensure that APM qualifying thresholds remain attainable and replacement of a scheduled cut to Medicare physician payments with an update reflective of inflationary pressures.
    • “These payment reforms have generated more than $28 billion in gross savings for Medicare over the past decade,” the organizations wrote. “The Centers for Medicare & Medicaid Services (CMS) recently released results showing that the Medicare Shared Savings Program and [Accountable Care Organization] REACH Model, the largest APMs in Medicare, generated $2.8 billion in net savings for the Medicare program in 2023, while improving patient access and quality.”  
  • HHS’s HRSA shares information on federal government spending to improve rural healthcare.
  • Per MedTech Dive,
    • “The Food and Drug Administration’s medical device center unveiled Thursday a pilot program meant to speed up notices to the public about potentially high-risk product recalls.
    • “The pilot aims to improve the time between when the FDA first knows about certain corrective actions on products and when the public and healthcare providers are notified. The actions include when companies remove products from the market, correct products or update use instructions due to potentially high safety risks.
    • “The program will provide “early alerts” of potentially high-risk device removals or corrections related to cardiovascular, gastro renal, general hospital, obstetrics and gynecology and urology, according to the FDA’s Center for Devices and Radiological Health. The center added, “At this time, there is no change to any other recall process or recall communication timelines for other areas.”
    • “Michelle Tarver, the new CDRH director, said in a statement that the program is meant to increase transparency.”
  • Kevin Moss writing in Federal News Network offers an Open Season checklist for federal employees while FedWeek shares “11 FAQs: Open Season & PSHB/FEHB Switchover.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is stable or declining in most areas. Seasonal influenza activity remains low nationally. RSV activity is elevated and continues to increase in the southern, central, and eastern United States, particularly in young children. Respiratory infections caused by the bacterium Mycoplasma pneumoniae remain elevated among young children in the United States.
    • “COVID-19
      • “Nationally, COVID-19 activity is stable or declining in most areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels. COVID-19 activity is low with no meaningful changes in infection levels predicted.
      • “CDC expects that the 2024-2025 COVID-19 vaccine will work well for currently circulating variants. For additional information, please see CDC COVID Data Tracker: Variant Proportions. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “RSV activity is elevated and continues to increase in the southern and eastern United States. Activity is low in the rest of the country but increasing in the central and western United States. Emergency department visits and hospitalization rates are increasing in young children in the southern, central, and eastern United States.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections afforded by vaccines.”
  • The University of Minnesota’s CIDRAP tells us,
    • “The US Centers for Disease Control and Prevention (CDC) said today that its tests have confirmed H5N1 avian flu in California’s recent suspected case, involving a child who had no known exposure to infected animals.
    • “Also, California announced another confirmed H5 case in a dairy farm worker. The new developments lift the state’s total to 29 human cases of H5 avian flu and the national total since the first of the year to 55.” * * *
    • “The child is recovering, and all family members tested negative for H5 avian influenza but positive for the same common respiratory virus as the child. Contact tracing continues, and there is no sign of human-to-human spread.
    • “Investigation into the child’s exposure to H5N1 is still under way, the CDC said.”
  • The New York Times reports,
    • “The number of deaths caused by alcohol-related diseases more than doubled among Americans between 1999 and 2020, according to new research. Alcohol was involved in nearly 50,000 deaths among adults ages 25 to 85 in 2020, up from just under 20,000 in 1999.
    • “The increases were in all age groups. The biggest spike was observed among adults ages 25 to 34, whose fatality rate increased nearly fourfold between 1999 and 2020.
    • “Women are still far less likely than men to die of an illness caused by alcohol, but they also experienced a steep surge, with rates rising 2.5-fold over 20 years.
    • “The new study, published in The American Journal of Medicine, drew on data from the Centers for Disease Control and Prevention.”
  • A Wall Street Journal reporter observes
    • “After years of pushing the benign myth that a glass of wine a day is good for the heart, it seems the medical establishment has abandoned hedonists and pleasure seekers. Is there a safe amount of alcohol? It turns out no. 
    • “For this and other more amorphous reasons, I have noticed increasing numbers of people around me are sober-ish. They drink only socially or only two glasses of wine a week or only in restaurants. They are not willing to give up drinking entirely, which feels like too vast and depressing a surrender of life’s pleasures. So they make rules for themselves. 
    • “Someone I know has a new ritual of drinking a nonalcoholic beer with nuts on her terrace. Another friend told me that she used to drop by for drinks at friends’ houses in the evenings, and now it is just as often tea.”
  • Medscape discusses the side effects of GLP-1 drugs.
    • “Just a few years after some TikTok videos spiked the demand, one in eight US adults has tried Ozempic (semaglutide) or another drug in its class. Glucagon-like peptide 1 (GLP-1) receptor agonist medications have revolutionized obesity medicine.
    • “But they’re not without problems. In the early days of the social media craze, news reports often featured patients whose gastrointestinal side effects sent them to the emergency room (ER).
    • “It happened a lot then. Patients didn’t want to complain because they were losing weight, and they wound up in the ER with extreme constipation or a small bowel obstruction,” said Caroline Apovian, MD, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.
    • “But that’s not really happening now,” she added.
    • “Research backs up her assertion: A recent clinical review of studies found that many patients still experience side effects, but only at a mild to moderate level, while the dosage increases — and the unpleasantness tapers with time. Roughly 7% of patients discontinue the medications due to these symptoms.”
  • KFF provides findings from its 2024 Women’s Health Survey concerning contraception.
  • Medical Economics informs us,
    • “More than one in five U.S. adults, which equates to 59.3 million people, were living with mental illnesses in 2022, yet just more than half of them (50.6%) had received treatment in the previous year. A new study, from West Health and Gallup, uncovered that 70% of Americans would prefer to be asked about both their physical health and their mental health during appointments with their primary care providers (PCPs).
    • ‘The West Health-Gallup Survey on Mental Health in America reported that 65% of men and 76% of women hoped to discuss both physical and mental health with their PCPs. The survey also found that 66% of U.S. adults have been asked about their mental health by their PCPs or family practitioners, whereas 32% of adults said that had never happened. Women were more likely than men (71% compared to 60%) to be asked about mental health.”
  • The University of Minnesota’s CIDRAP lets us know,
    • “Yesterday, the US Centers for Disease Control and Prevention (CDC) closed its investigation into the multistate Listeria outbreak tied to Boar’s Head deli meat after 61 cases and 10 deaths were reported.”
  • The Food and Drug Administration announced,
    • “On Thursday, the FDA updated the outbreak advisory for E. coli O21:H19 infections linked to organic whole and baby carrots supplied by Grimmway Farms. The retail-packaged organic whole carrots were in stores for purchase from August 14 through October 23, 2024. The organic baby carrots have different best-if-used-by-dates ranging from September 11 through November 12, 2024. The update includes information about recalled product being distributed to markets outside the United States and additional recalls from companies that may have used or repackaged recalled carrots from Grimmway Farms. FDA’s investigation remains ongoing.”
  • The Washington Post reports,
    • “The Detroit-based Wolverine Packing Co. recalled more than 167,000 pounds of ground beef products because of concerns that the meat may be contaminated with E. coli, according to the U.S. Department of Agriculture. The recall affects fresh products that have a use-by date of Nov. 14 and frozen products whose labels contain a production date of Oct. 22, officials said.
    • “On Nov. 13, Minnesota’s Department of Agriculture alerted the Food Safety and Inspection Service, an agency of the USDA, about a group of people who had consumed ground beef before they fell ill.
    • ‘On Nov. 20, a ground beef sample collected by Minnesota officials tested positive for E. coli O157. Federal officials determined that the products from Wolverine Packing Co. were linked to the people who had become sickened in Minnesota.
    • “At least 15 patients have been identified, and the onset of their infections range from Nov. 2 to Nov. 10, the USDA said. At least two have been hospitalized, according to Minnesota officials.
    • “The recalled products have the establishment number EST. 2574B inside the USDA mark of inspection. The items were shipped to restaurant locations nationwide, according to officials.
    • Some products may be in restaurant refrigerators or freezers, officials said.
    • “Restaurants are urged not to serve these products.”

From the U.S. healthcare business front,

  • HR Dive relates,
    • “Insurers are projecting medical costs will increase globally in 2025 — by about 10.4%, according to WTW’s 2025 Global Medical Trends Survey.
    • “Specifically in the U.S., insurers project a 10.2% increase in 2025, up from 9.3% this year.
    • “Notably, WTW researchers said that public healthcare systems worldwide have been overwhelmed due to high demand and low resources, which has led to people turning to private providers.”
  • Health Leaders Media discusses an Oschner Health program with myLaurel which offers value-based medical care at home.
    • “Billing arrangements are a key difference between CMS’ Acute Hospital Care at Home program and Ochsner Health’s Acute Care at Home program.
    • “The Acute Care at Home program features virtual visits with physicians, nurses, and care managers as well as in-person visits with paramedics.
    • “By reducing hospital admissions and readmissions, the Acute Care at Home program is decreasing total cost of care.”
  • Investment News reports,
    • “Despite the benefits of health savings accounts as tax-advantaged retirement savings tools, employees are largely using them to meet current healthcare expenses, according to a new survey by the Plan Sponsor Council of America.
    • “The 2024 HSA Survey, sponsored by HSA Bank, reflects responses from more than 500 employers and shows modest growth in account balances and contributions. However, it also highlights a need for greater education around the long-term benefits of HSAs.
    • “While 90 percent of eligible employees had an HSA in 2023 and three-quarters made contributions, few are leveraging them for retirement planning.
    • “Among other key insights, the survey found that only one-third of employers educate workers about using HSAs as part of their retirement strategies, and fewer than 30 percent allow participants to view their HSA balances alongside retirement accounts for a more holistic view of savings. Less than 10 percent of employers mirror HSA investment options with those available in their 401(k) plans, though interest in doing so has grown.”
  • The Wall Street Journal reports,
    • “An industry fight against lucrative drug discounts for hospitals is intensifying as another drugmaker joins the battle: Sanofi.
    • “The pharmaceutical company plans to change its policy on how it gives discounts to certain hospitals. Sanofi will require institutions to provide pharmacy and medical claims information before receiving federally mandated discounts. The company sent a letter, which was viewed by The Wall Street Journal, to hospitals outlining its new model on Friday, according to people familiar with the matter. 
    • “The French company’s plan, which would take effect early next year, comes as the industry escalates its efforts to rein in the federal program known as 340B. Eli Lilly and Johnson & Johnson this month filed separate lawsuits against the federal government for rejecting the companies’ plans to tighten the way they provide the discounts to hospitals in the program.” 
  • Per BioPharma Dive,
    • “Medtronic received Food and Drug Administration clearance for its new InPen smart insulin pen app that can recommend corrections for missed or inaccurate insulin doses at mealtime.
    • “The authorization paves the way for the launch of Medtronic’s Smart MDI system, which combines InPen with the Simplera continuous glucose monitor (CGM), the company said Wednesday. 
    • “With the clearance, Medtronic said Smart MDI will be the first system on the market to provide personalized insights on when and how much insulin to dose in real-time for people who take multiple daily injections.”

Thursday Miscellany

David Ermer–CDC, CMS, FDA, Generative AI, Medical / Rx research, Medicare, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “President-elect Donald Trump said he would nominate environmental lawyer and vaccine skeptic Robert F. Kennedy Jr. to serve as health and human services secretary, putting a noted critic of U.S. public policy atop the country’s vast health bureaucracy. 
    • “Kennedy has promised sweeping changes to food-and-drug regulation and government-funded scientific research, in recent days saying the Food and Drug Administration’s nutrition department needed to be eliminated and warning the agency’s employees to “pack your bags.”
    • “Kennedy, 70 years old, abandoned his independent presidential bid in August and endorsed Trump, promising that he and the Republican would work to “make America healthy again.”
    • “Kennedy said on social media after his nomination that “we have a generational opportunity to bring together the greatest minds in science, medicine, industry, and government to put an end to the chronic disease epidemic.”
  • Per an HHS press release,
    • “Today, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), announced a new nationwide campaign to raise public awareness of the National Maternal Mental Health Hotline (1-833-TLC-MAMA). The National Maternal Mental Health Hotline is a cornerstone of the Biden-Harris Administration’s broader efforts to improve maternal health and supports HRSA’s ongoing initiative to reduce maternal mortality and health disparities. While mental health conditions are the leading cause of pregnancy-related deaths, more than 80 percent of pregnancy-related deaths are preventable according to the Centers for Disease Control and Prevention (CDC).
    • “As part of the campaign, HHS will collaborate with companies and organizations such as retailers, grocers, pharmacies, and health and community associations to publicize mental health resources for moms and pregnant women in everyday locations. The first six Maternal Mental Health Champions announced today have thousands of locations and a broad presence in all 50 states, Washington, D.C., Puerto Rico, and the U.S. Virgin Islands. HRSA Deputy Administrator Jordan Grossman announced this campaign in conjunction with HRSA’s latest state Enhancing Maternal Health Initiative convening in Portland, Oregon.” * * *
    • “The National Maternal Mental Health Hotline is a safe space for pregnant women and new moms to get the emotional and mental health support they need, and we want to continue to reach even more pregnant women, new moms, and their loved ones with this vital support,” said HRSA Administrator Carole Johnson. “That’s why we are excited to partner with grocery stores, pharmacies, and other organizations to help get the word out about this important resource for in communities across the country.” * * *
    • “For more information on the National Maternal Mental Health Hotline and to download new promotional materials, visit: https://mchb.hrsa.gov/national-maternal-mental-health-hotline.”
  • Healthcare Dive lets us know,
    • “The Biden administration is moving to lessen the importance of a controversial metric used to calculate valuable Medicare Advantage star ratings that’s been at the center of recent lawsuits.
    • “UnitedHealthcare, Centene and Humana have all sued the government this fall for downgrading their quality scores based on assessments of their customer support centers. Payers argued the measure had an outsized impact on final star ratings, and it now seems regulators might agree.
    • “We have already put in place that [the call center metric] is going to have a smaller weighting on star ratings moving forward,” CMS Medicare Director Meena Seshamani said Wednesday at the Milken Institute’s Future of Health Summit in Washington, D.C.”
  • Federal News Network interviews OPM Director Rob Shriver about the Federal Employee Benefits Open Season.
  • Tammy Flanagan, writing in Govexec, identifies federal and postal employee “retirement decisions that require careful consideration since they cannot be changed.”
  • Federal News Network tells us,
    • “The Postal Service is reporting a deeper financial loss than it’s seen in recent years and is calling on Congress and the incoming Trump administration to address rising costs that are beyond its control.  
    • “USPS reported a $9.5 billion net loss for fiscal 2024, despite year-over-year growth in revenue and a reduction in its controllable expenses. The agency saw a $6.5 billion loss in FY 2023. 
    • “USPS officials said 80% of the agency’s losses come from fixed costs — including pension contributions for its retirees and workers’ compensation claims for employees injured on the job.  
    • “The agency will not seek to raise mail prices in January 2025, but it plans to keep setting higher prices each July and January after that, through the end of 2027.
    • “USPS projections show the agency will end FY 2025 with a $6.9 billion net loss for FY 2025 and is falling short of its “break-even” goal under a 10-year reform plan.” 

From the public health and medical research front,

  • STAT News reports,
    • “A Canadian teenager who is in critical condition after contracting H5N1 bird flu was infected with a version of the virus that is different from the one circulating in dairy cattle in the United States, Canadian authorities announced Wednesday.
    • “The National Microbiology Laboratory in Winnipeg confirmed the infection was indeed caused by the H5N1 virus. But genetic sequencing showed that it is of a genotype that has been found in wild birds, not the version that has been circulating in dairy cattle in the U.S. 
    • “Canada has been doing surveillance in dairy cows looking for the virus, but to date has not detected it in any herds.
    • “Bonnie Henry, British Columbia’s provincial health officer, told STAT in an interview that she’d been expecting these genetic sequencing results. “That’s what we’ve been seeing consistently,” she said.”
  • HCPLive informs us,
    • “Initiation of population-wide screening for chronic kidney disease (CKD) followed by treatment with conventional CKD therapy combined with sodium-glucose cotransporter-2 (SGLT2) inhibitors would be cost-effective for US adults when initiated at 55 years of age, according to findings from a recent study.
    • “Results showed screening every 5 years combined with SGLT2 inhibitors from 55-75 years of age would cost $128,400 per quality-adjusted life year (QALY) gained. While initiation of screening at 35 or 45 years of age produced larger population health benefits, these strategies incurred additional costs totaling> $200,000 per QALY gained.
    • “In the absence of effective CKD treatment options at the time, in 2012, the US Preventive Services Task Force found insufficient evidence to show screening and early detection of CKD improved clinical outcomes. However, the recent emergence of SGLT2 inhibitors as a practice-changing therapy for CKD has prompted clinical guideline organizations to update standard of care recommendations for CKD to include these medications.”
  • Per BioPharma Dive,
    • “PTC Therapeutics on Wednesday won Food and Drug Administration approval for Kebilidi, the first gene therapy cleared in the U.S. for direct administration to the brain.
    • “The treatment is designed for patients with aromatic L-amino acid decarboxylase, or AADC, deficiency, a condition that affects the way neurons transmit information to other cells. The potentially fatal disorder typically manifests in the first six months after babies are born and affects all aspects of their lives, both physical and mental.
    • “Kebilidi is designed to deliver a functioning DDC gene into the body, correcting the genetic defect that causes the disorder. It’s administered by a neurosurgeon in four infusions in one session.”
  • Healthcare Dive relates,
    • “Increased telehealth utilization wasn’t linked to more low-value services at primary care clinics, according to a study published this week in JAMA Network Open.
    • “The research found no association between practices that used high levels of telehealth and most types of low-value care, or services that have no clinical benefit for patients and rack up costs.
    • “The findings could reassure policymakers who have raised concerns that virtual care could increase unnecessary or wasteful services and drive-up healthcare spending, the study’s authors wrote.” 
  • The Wall Street Journal reports,
    • “Intermittent fasting probably isn’t the health hack you hoped it would be.
    • “More studies suggest the tactic can help you lose weight, but likely isn’t a silver bullet for other health improvements like lowering your inflammation levels or lengthening your lifespan. And some evidence suggests fasting can make it harder to build and retain muscle.
    • “People were hoping it was this magical thing that did amazing things for them,” says Krista Varady, a professor of nutrition at the University of Illinois Chicago who has been studying intermittent fasting for 20 years. “All it does is help people eat less.”

From the U.S. healthcare business front,

  • AHIP lets us know,
    • “With more than half of Americans – approximately 180 million people – receiving health care coverage through work, a new nationwide poll finds that a strong majority are satisfied with their current employer-provided plans (75%) and prefer to get their coverage through an employer rather than through the federal or state government (74%).
    • “The poll found that Americans’ satisfaction with employer-provided coverage is driven by the comprehensive coverage (49%), affordability (48%) and choice of providers (45%) their plans provide.” * * *
    • “The national survey of 1,000 people with employer-provided coverage was conducted online from July 10-19, 2024, with a margin of error of +/- 3%. 
      • “Click here to view the infographic.
      • “Click here to view the survey results.
      • “Click here to view a slide presentation of the survey results.”
  • Fierce Healthcare reports about the second day of its Fierce Health Payer Summit.
  • The FEHBlog took sometime today listening to the HCPLAN Summit, which was held in Baltimore. At the Summit, HCPLAN released the 2024 results of its Alternative Payment Models survey.
  • Adam Fein, writing in his Drug Channels blog, points out,
    • “Uh oh. As I predicted, the stand-alone Medicare Part D prescription drug plans (PDP) market is vanishing.
    • “For 2025, DCI’s exclusive analysis of Center for Medicare & Medicaid Services’ (CMS) data reveals that the number of PDPs will drop to a historic low. What’s more, the share of plans with a preferred cost sharing pharmacy network will fall to its lowest rate in more than 10 years. Check out the distressing charts below and our review of the remaining national players (Aetna, Cigna, Humana, UnitedHealthcare, and WellCare). 
    • “The destruction of the Part D market marks yet another unintended consequence of the Inflation Reduction Act of 2022 (IRA). The IRA makes PDPs less economically viable and will drive even more seniors into Medicare Advantage Prescription Drug (MA-PD) plans—despite the challenges facing those plans. The 2025 decline will occur even after CMS gifted $7 billion to PDPs to prevent a complete collapse of the 2025 market. 
    • “Legislate in haste. Repent in leisure.”
  • STAT News reports,
    • “In a move to safeguard the company’s dominant position in cancer, Merck said Thursday it will license a new cancer drug from LaNova Medicines, a Shanghai-based firm, for $588 million upfront and as much as $2.7 billion in potential milestone payments.
    • “The cancer immunotherapy Keytruda, Merck’s most important product and the best-selling drug in the world with $23 billion in annual sales, is set to lose patent protection and face competition from generic drugmakers as early as 2028, and investors are already fretting about what will happen at Merck when revenues from the medicine begin to decline.”
  • Healthcare Dive lets us know,
    • “A group of health systems, led by Boston-based Mass General Brigham, is hoping to solve that problem. 
    • “On Wednesday, the academic medical center launched the Healthcare AI Challenge Collaborative, which will allow participating clinicians to test the latest AI offerings in simulated clinical settings. Clinicians will pit models against each other in head-to-head competition and produce public rankings of the commercial tools by the end of the year.
    • “Participating health systems say that the chance to directly compare AI products is overdue.”
  • Per Fierce Healthcare,
    • “Blue Cross Blue Shield of Massachusetts members will benefit from an expanded partnership with Maven Clinic, a new doula pilot program and more caregiving support in collaboration with Cleo, the company announced Nov. 13.
    • “Its doula program, called Accompany Doula Care, connects “racially and ethnically diverse” members with a trained doula. The pilot will collect data to assess whether the program is adequately reaching members through the birthing timeline, including prenatal visits, in-person support during childbirth and postpartum visits.
    • “Black women experience higher levels of maternal morbidity, Blue Cross’ health equity report found.
    • “Eligible Blues members will also have access to Maven Clinic’s Menopause and Midlife Health program. This program can be utilized as a buy-up for self-insured accounts, a news release explains.”
  • and
    • “Amazon One Medical is rolling out a new service to provide Prime members access to clinical treatments for common health and lifestyle conditions like men’s hair loss and anti-aging skin care.
    • “The new service builds on Amazon One Medical’s existing Pay-per-visit telehealth service that offers healthcare for more than 30 common conditions.
    • “The new service offers a subscription plan with low, upfront monthly pricing for a clinical visit, treatment plan, and free medication delivery. The service initially focuses on five conditions: anti-aging skin care treatment, men’s hair loss, erectile dysfunction, eyelash growth, and motion sickness.
    • “Through this service, Prime members can get anti-aging skin care treatment from $10/month; men’s hair loss solutions from $16/month; ED treatment from $19/month; eyelash growth solutions from $43/month; and treatment for motion sickness from $2/use—using Prime Rx at checkout, the company said in a blog post Thursday.”

Weekend Update

David Ermer–Congress, COVID-19, Federal employment benefits, Medical / Rx research, Mental health care, OPM, Telehealth, U.S. Healthcare–

From Washington, DC,

  • As we all know, the national election is Tuesday. The current Congress will return to Capitol Hill the following Tuesday November 12, to begin its lame duck session. The new Congress will begin on January 3, 2025.
  • In anticipation of the Federal Employee Benefits Open Season that begins on November 11, OPM has posted 2025 FEHBP and FEDVIP plan comparison tools on its website.
  • Modern Healthcare reports,
    • “Elevance Health is the latest Medicare Advantage insurer to dispute its star ratings quality scores in court.
    • “The health insurance company filed suit against the federal government in the U.S. District Court for the Northern District of Texas on Thursday. According to Elevance Health, the Centers for Medicare and Medicaid Services improperly assessed its quality performance, costing the insurer $375 million in bonus payments. The company won a case regarding its 2024-star ratings on different grounds, which led the agency to recalculate scores across the program.
    • “Elevance Health wants the court to order CMS to redo its ratings and to provide insurers with the data to “validate the 2025-star ratings calculations and future star ratings calculations,” according to its lawsuit. The insurer also seeks reimbursement the court deems appropriate.”

From the public health and medical research front,

  • CBS News asks and answers “Do I have COVID, the flu or something else? 2024 symptoms and testing to know.”
  • The New York Times lets us know,
    • “More than 80 percent of emergency departments in United States hospitals are not fully prepared for pediatric cases, a new study finds, despite the fact that children make up about 20 percent of visits each year.
    • “The new analysis, published Friday in the journal JAMA Network Open, estimated that if every emergency department in the United States had the core features of “pediatric readiness,” more than a quarter of the child deaths that follow E.R. visits could be prevented, a figure that equates to thousands of young lives each year.
    • “Even in the most ill-prepared states, the cost to ready every emergency room would be less than $12 per child living there, the researchers found.
    • “You can now find your state and see: How many children who would otherwise die could we expect to save if we implemented universal pediatric readiness at a high level?” said Dr. Craig Newgard, who was the lead author on the paper, and is the director of the Center for Policy and Research in Emergency Medicine at Oregon Health & Science University.”
  • The Washington Post informs us,
    • “Migraine is a surprisingly common problem, affecting an estimated 15 percent of the global population. Scientists don’t know how triggers lead to attacks but have made some progress in treatment: The latest drugs, inhibitors of a body signaling molecule called CGRP first approved for use in 2018, have been a blessing for many. For others, not so much. And it’s not clear why.”
    • * * * “Despite some failures, CGRP’s successes show that there’s hope for new medicines. CGRP has really paved the way,” says Andrew Russo, a neuroscientist at the University of Iowa in Iowa City who described CGRP as a new migraine target for the Annual Review of Pharmacology and Toxicology in 2015. “It’s a very exciting time for the field.”
  • Fortune Well informs us,
    • “Binge drinking is prevalent across generations, but the dangerous habit is growing among one age group in particular. 
    • “Long associated with college students, binge drinking, defined as having four or more drinks within two hours at least five times per month for women (five drinks for men) is on the rise among older adults. According to The National Survey on Drug Use and Health, 20% of adults aged 60 to 64, reported binge drinking in the last month. For those older than 65, the prevalence of binge drinking is 12%—a rate that has been increasing over the last decade, while binge drinking rates among young adults 18 to 25 have been going down.” * * *
    • “For more education on how to assess your—or a family member’s—drinking habits, visit the NIAAA Healthcare Professional’s Core Resource on Alcohol.”

From the U.S. healthcare business front,

  • Per Legal Dive,
    • “Pennsylvania’s attorney general sued Prospect Medical Holdings and its former parent company, alleging mismanagement by the hospital chain caused two hospital closures and widespread disruptions to patient care.
    • “The lawsuit Tuesday argues Prospect broke the terms of its 2016 purchase agreement of four-hospital system Crozer Health, which required Prospect to keep all acute care hospitals open for at least 10 years.
    • ‘In the suit, Attorney General Michelle Henry asks for a preliminary injunction barring Prospect from closing more hospitals and requests an official receiver step in and manage Crozer Health.”
  • Modern Healthcare tells us,
    • “Zoom, a company that rose to prominence during the COVID-19 pandemic, is looking to expand its presence in healthcare through artificial intelligence. 
    • “The company recently announced plans to incorporate ambient AI documentation technology from digital health company Suki in its clinical platform. Zoom plans to use the ambient AI technology, which turns a recording of a doctor-patient conversation into usable clinical notes in the electronic health record, for virtual and in-person visits. 
    • “It’s the latest move in healthcare from the video teleconferencing company, which has offered telehealth services since 2018.”
  • Per HR Dive,
    • “While the median salary increase stayed at 4% in 2024, average increases dropped from 4.3% to 3.9%, according to survey results collected by Salary.com from more than 1,000 HR professionals in the U.S. and Canada.
    • “The drop is due to fewer companies doling out higher raises, Salary.com found; only 14% of companies gave out raises between 5% and 6.9%, compared with 25% of companies in the previous survey. Additionally, more companies — 38% in 2024, compared to 25% in 2023 — returned to “typical” salary increases in the 3% to 3.9% range.
    • “Last year, we noted that salary increases might be at a peak, even with 4 percent becoming the norm,” Andy Miller, vice president of compensation consulting at Salary.com, said in an Oct. 29 news release. “While 4 percent remained the median in 2024, further analysis suggests a shift is happening.”

Happy Halloween

David Ermer–CMS, COVID-19, Electronic health records, FDA, Medical / Rx research, Medicare, NIH, Obesity, Telehealth, U.S. Healthcare–
Photo by Toa Heftiba on Unsplash

From Washington, DC,

  • Tammy Flanagan, writing in Govexec, answers Federal Benefits Open Season questions from readers.
  • Bloomberg reports,
    • “The [U.S. Court of Appeals for the] Third Circuit [sitting in Philadelphia] Wednesday wrestled with the constitutionality of a government drug price negotiation plan, hearing arguments from three drugmakers and the Biden administration over alleged industry harm and violations of property and speech. 
    • “Drugmakers Johnson & Johnson, Bristol-Myers Squibb Co., and AstraZeneca PLC took their challenge against the US government’s Medicare Drug Price Negotiation Program to the US Court of Appeals for the Third Circuit. The plan, created under President Joe Biden’s landmark Inflation Reduction Act, is part of the administration’s efforts to rein in high prescription drug costs by allowing the government to negotiate prices for certain drugs with manufacturers.” 
    • This is the first federal appellate court oral argument on this issue.

From the public health and medical research front,

  • Dr. Monica Bertagnollo, the NIH Director, writes in her blog,
    • “In 2021, NIH launched the Researching COVID to Enhance Recovery (RECOVER) Initiative , a nationwide research program, to fully understand, diagnose, and treat Long COVID. We continue to learn more about this condition, in which some people experience a variety of symptoms for weeks, months, or even years after infection with SARS-CoV-2, the virus that causes COVID-19. But we’re still working to understand the underlying reasons why people develop Long COVID, who is most likely to get it, and how best to treat or prevent it.
    • “Studies have shown that for some people, SARS-CoV-2 doesn’t completely clear out after acute infection. Scientists have observed signs that the virus may persist in various parts of the body, and many suspect that this lingering virus, or remnants consisting of SARS-CoV-2 protein, may be causing Long COVID symptoms in some individuals. Now, in a new study supported by RECOVER, scientists found that people with Long COVID were twice as likely to have these viral remnants in their blood as people with no lingering symptoms. The findings, reported in Clinical Microbiology and Infection, add to evidence that Long COVID may sometimes stem from persistent infection or SARS-CoV-2 protein remnants.” * * *
    • “More study is needed to understand the causes of Long COVID symptoms in people who test negative for persistent infection, the researchers note. They are conducting follow-up studies in even more people with Long COVID, including those with compromised immune systems. They hope to learn more about what causes some people to be at higher risk for retaining some SARS-CoV-2 protein remnants and Long COVID.”
  • Per an NIH press release,
    • “Young people with severe obesity who underwent weight-loss surgery at age 19 or younger continued to see sustained weight loss and resolution of common obesity-related comorbidities 10 years later, according to results from a large clinical study funded by the National Institutes of Health (NIH).
    • “Study participants with an average age of 17 underwent gastric bypass or sleeve gastrectomy weight-loss surgery. After 10 years, participants sustained an average of 20% reduction in body mass index (BMI), 55% reduction of type 2 diabetes, 57% reduction of hypertension, and 54% reduction of abnormal cholesterol. Both gastric bypass and sleeve gastrectomy had similar results.
    • “The 55% reduction in type 2 diabetes was much higher than the rates observed in adults after weight-loss surgery (18% at seven years and 12.7% at 12 years) in a recently published NIH-funded study.
    • “Type 2 diabetes tends to progress more rapidly when it occurs in young people, and these findings demonstrate the greater health benefits and durability of bariatric surgery in youth than would be expected in similarly treated adults.”
  • JAMA Open Network tells us,
    • Question  How have autism diagnosis rates changed over time among children and adults seeking care from a network of health systems in the US?
    • Findings  In this cross-sectional study of electronic US health and insurance claims records for over 9 million individuals per year from 2011 to 2022, relative increases in autism diagnosis rates were greatest among young adults compared with all other age groups, female compared with male individuals, and some racial and ethnic minority groups compared with White individuals among children but not adults.
    • Meaning  Patterns of increase in autism diagnosis rates reflect a need for expanded health care services and continued research on sociodemographic disparities among this growing population.
  • The Institute for Clinical and Economic Review published an Evidence Report on Treatment for Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease
    • Current evidence suggests that tabelecleucel provides a substantial net health benefit when compared to usual care; treatment would achieve common thresholds for cost-effectiveness if priced between $143,900 to $273,700 per treatment cycle. * * *
    • “EBV+ PTLD is a rare and often fatal cancer associated with solid organ transplant and stem cell transplant,” said ICER’s Vice President of Research Foluso Agboola, MBBS, MPH. “Unfortunately, approximately half of EBV+ PTLD cases are refractory to initial treatment or relapse, resulting in a poor prognosis. The limited evidence on tabelecleucel suggests that it provides important clinical benefits in patients with relapsed refractory EBV+ PTLD, extending survival for patients who otherwise do not usually survive beyond a few weeks to months, with few harms.” 
    • “This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC on November 14, 2024. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”
  • STAT News informs us,
    • After spending decades fixated on a single hypothesis, Alzheimer’s researchers are increasingly searching for new ways to combat the devastating neurologic disease. One such approach — precisely targeting the brain with magnetic pulses — got a boost when mid-stage trial data was presented Thursday.
    • Scientists reported that patients with mild or moderate Alzheimer’s who received the therapy, known as transcranial magnetic stimulation (TMS), experienced a 44% slowing in their rate of disease progression after a year compared to those given a sham intervention, which mimicked the procedure but delivered no treatment. That finding, which was the study’s main endpoint and was statistically significant, was based on a commonly used disease metric known as Clinical Dementia Rating sum of boxes (CDR-SB).” * * *
    • “But outside experts were quick to caution that the new results, announced at the Clinical Trials on Alzheimer’s Disease conference in Madrid, should be taken with a grain of salt. That’s because the findings come from a small Phase 2 trial conducted at a single medical center in Italy, with 32 patients completing the trial. Sinaptica, a private biotech in Cambridge, Mass. that is developing the treatment and sponsored the trial, is now planning a larger, multicenter pivotal study in hopes of confirming its findings.”

From the U.S. healthcare business front,

  • The American Hospital News lets us know,
    • “Baxter announced Oct. 31 that it has restarted its North Cove, N.C. facility’s highest-throughput IV solutions manufacturing line, which normally accounts for nearly 25% of the site’s total production and approximately 50% of its one-liter IV solutions — the most commonly used size by hospitals and clinics. The earliest new products could begin shipment is late November, Baxter said. The company is continuing to assess and repair equipment at the facility and is working with the Food and Drug Administration to resume operation in phases. Baxter said it does not have a timeline on when production at the facility will be restored to pre-Hurricane Helene levels.” 
  • Healthcare Dive relates,
    • “Cigna CEO David Cordani threw cold water on speculation that the health insurer is interested in acquiring rival Humana during a call with investors on Thursday.
    • “Despite reports earlier this fall that the two payers had reopened deal talks, Cigna plans to use excess cash to buy back shares, Cordani said while discussing Cigna’s third quarter results.
    • “Cigna handily beat Wall Street expectations in the quarter with revenue of $63.7 billion, up 30% year over year after strong demand for specialty drugs spurred growth in its health services division. However, an investment loss of $1 billion tied to the waning value of primary care chain VillageMD drove Cigna’s profit down to $739 million, compared to $1.4 billion same time last year.”
  • Risk & Insurance points out,
    • “Employers that implement strategies like value-based drug formularies and tiered provider networks are experiencing lower health care costs, according to a survey by the National Alliance of Healthcare Purchaser Coalitions.
    • “The survey, which included responses from 188 employers, sheds light on the ongoing challenge of rising health care costs and the various approaches being taken to address this issue, which has significant implications for both businesses and employees.”
  • Modern Healthcare informs us,
    • “Steward Health Care completed the $245 million sale of its physician group, Stewardship Health, to private equity-owned Rural Healthcare Group.
    • “As part of the transaction, Kinderhook Industries, the private equity firm that owns Rural Healthcare Group, plans to rebrand the combined company as Revere Medical, Kinderhook said Thursday in a news release. The acquisition adds about 5,000 employed and affiliated Stewardship physicians across nine states to Revere’s network of 17 primary care clinics in Tennessee and North Carolina.
    • “Revere plans to invest in Stewardship infrastructure and technology and has pledged to allow patients to stay with their doctors, according to the release.
    • “The Stewardship team is excited for this next chapter with Revere Medical as it provides a committed partner focused on quality care and improving the clinic experience for providers, clinic teams, and patients,” Dr. Joseph Weinstein, president of Stewardship, said in the release.
    • “The Stewardship sale is one of the last remaining transactions in Steward’s Chapter 11 bankruptcy restructuring.”
  • Per Fierce Healthcare,
    • “Optum Rx is rolling out a slate of new programs that seek to support independent pharmacies in managing costs and more complex patient needs.
    • “The first offering under this initiative is Optum’s new Independent Pharmacy Network, which is available as an add-on for its pharmacy benefit management clients. In contracts that select this option, independent and community pharmacies will receive 5% higher reimbursements for generics and 0.2% higher for branded drugs.
    • “The PBM said this program follows other changes enacted to support independent pharmacies; for instance, it does not collect direct and indirect remuneration, or DIR, fees and removed clawbacks for independent facilities.”
  • and
    • “Teladoc Health had a better quarter than Wall Street expected, posting $640.5 million in revenue and losing less per share than expected, at $0.19. Quarterly revenue decreased by 3% from 2023 and was down slightly from Q2’s $642.4 million.
    • “In the Q3 earnings call, Teladoc executives stressed the stability of the U.S. virtual care segment, which has gained millions of users since last year. It called BetterHelp a “company in transition,” as the company pivots hard to offset the cost of a $790 million impairment charge in the second quarter.
    • “BetterHelp, Teladoc’s virtual mental health solution, continue to drag down its performance as the segment’s revenue fell 10% year-over-year, coming in at $256.8 million in Q3.”
  • Per Fierce Pharma,
    • “Bristol Myers’ $1.5 billion restructuring initiative that runs through 2025 may not be the end of the company’s ongoing efficiency push. 
    • “BMS management is “reviewing overall spending and prioritizing investments that will deliver the best long-term returns,” CEO Chris Boerner, Ph.D., said during a call Thursday. The New Jersey-based pharma is on track to deliver on its existing $1.5 billion cost-saving target by the end of next year, the CEO confirmed.
    • “We see the drive for greater operational excellence as a continuous process,” Boerner continued. “As such, we are exploring opportunities to further improve productivity and efficiency over the coming quarters.”
    • “Later during the call, CFO David Elkins said BMS is “continuing to look for efficiencies in our cost base, and you’ll continue to hear more about that.”
  • Per BioPharma Dive,
    • “Sales of GSK’s top-selling vaccines fell sharply during the third quarter amid lower demand, sending shares in the British pharmaceutical company down 3% in U.S. trading Wednesday.
    • “GSK, which had downgraded its vaccine sales forecasts in July, did so again Wednesday in reporting earnings for the third quarter. The company now expects vaccine sales to decline by low single digits versus last year.
    • “During the third quarter, sales of GSK’s shingles vaccine dropped by 7% compared to the same period in 2023, while sales of its shot for respiratory syncytial virus, Arexvy, plunged by 72% year over year.
    • “In a presentation, GSK attributed the drop of Arexvy to several factors, including a narrower recommendation from the Centers for Disease Control and Prevention, prioritization of COVID vaccinations in the U.S. and lower rates of RSV infections this season.
    • “The decline mirrored that of Pfizer’s competing vaccine Abrysvo, sales of which came in lower this quarter compared to last year’s. Pfizer also cited the CDC recommendation, which focuses on vaccination for adults 75 years or older, as well as those between 60 and 74 years who are at higher risk of disease. Previously, the CDC had urged all adults 60 and older — for whom both Arexvy and Abrysvo are approved — to discuss vaccination with their doctor.”
  • Per Healthcare Dive,
    • “Oracle will launch a new artificial intelligence-backed electronic health record next year, the technology giant said Tuesday.
    • “The EHR will allow clinicians to use voice for navigation and search. It will also integrate the company’s clinical AI agent and tools for data analysis and tracking patient flow through the hospital.
    • “The new record marks a major health initiative for Oracle, which acquired EHR vendor Cerner for more than $28 billion in 2022. “This isn’t a refurbished Cerner EHR,” Seema Verma, executive vice president and general manager of Oracle Health and Life Sciences, said during the Oracle Health Summit on Tuesday. “Because in this day and age, you can’t leverage modern technology by bolting new innovation to something built in the 1990s.”

Friday Factoids

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

From Washington, DC

  • An HHS fact sheet lets us know,
    • ‘Following storm damage from Hurricane Helene at Baxter International Inc.’s facility in North Carolina, the U.S. Department of Health and Human Services (HHS) and its subagencies continue taking action to support access to intravenous (IV) fluids, including ensuring restoration of key production sites, protecting products, and opening imports, in partnership with manufacturers, distributors, hospitals, and other stakeholders. As a result of these steps, hospitals have 50% more product available to them now compared to right after the hurricane. Baxter has moved and begun distributing more than 450 truckloads of product from their North Carolina facility over the past 10 days and is already importing additional product from their foreign plants. FDA acted quickly to conduct scientific and regulatory assessments to help facilitate the temporary importation of 23 different IV and peritoneal (PD) fluids from five Baxter facilities around the world. Baxter communicated that supply availability is continually improving, and they expect to further increase customer allocations to 90%-100% of historical levels for many IV solution product codes no later than the end of the year. These supply improvements, combined with increased output from other manufacturers, will help hospitals get more of the product they need over the coming weeks.
    • ‘HHS, Food and Drug Administration (FDA), the Administration for Strategic Preparedness and Response (ASPR), and the Centers for Disease Control and Prevention (CDC) continue to use all available authorities to protect patients, support supply, and keep stakeholders informed, in partnership with manufacturers, distributors, hospitals, and other stakeholders. Additionally, HHS is announcing additional information about the airlift of Baxter products into the U.S. from international facilities, with first flights scheduled for October 19.‘
  • The New York Times reports,
    • “The Veterans Affairs Department is investigating whether Acadia Healthcare, one of the country’s largest chains of psychiatric hospitals, is defrauding government health insurance programs by holding patients longer than is medically necessary, according to three people with knowledge of the inquiry.
    • “The investigation, led by the agency’s inspector general, comes three weeks after Acadia told investors that it was facing scrutiny for its admissions practices from several other federal investigators, including prosecutors in Manhattan and a grand jury in Missouri. The company, which relies on government insurance programs like Medicare and Medicaid for much of its revenue, said it was also expecting to receive inquiries from the Securities and Exchange Commission and other agencies.
    • “Acadia told investors that it was “fully cooperating with authorities and, at this time, cannot speculate on whether the outcome of these investigations will have any impact on its business or operations.” The company has denied claims that it was improperly holding patients and has said that all decisions about care are made by licensed medical professionals.”
  • STAT News informs us,
    • “Prescription medicines purchased in the U.S. under a controversial government discount program amounted to $63 billion in 2023, a 23.4% increase from the previous year, according to the Health Resources & Services Administration, which oversees the program.
    • “The data mark a steady rise in sales under the 340B Drug Discount Program, which requires drugmakers to offer discounts that are typically estimated to be 25% to 50% — but could be higher — off all outpatient drugs to hospitals and clinics that primarily serve lower-income patients. There are more than 12,000 entities participating in the program, a number that has grown substantially.
    • “Since it began more than 30 years ago, the program has ballooned and fed into the national clash over the cost of medicines. Some $38 billion in prescription medications were purchased under the 340B program in 2020, for instance, which was up from $16.2 billion in 2016. And this fast-paced trajectory has triggered a battle between the pharmaceutical and hospital industries.”

From the public health and medical research front

  • The Center for Disease Control and Prevention announced,
    • “COVID-19 activity is declining in all areas. Minimal seasonal influenza activity is occurring nationally. Signs of increased RSV activity have been detected in the southeastern United States, particularly in young children. Respiratory infections caused by the bacterium Mycoplasma pneumoniae have increased in the United States, especially in young children.
    • “COVID-19
      • “Nationally, COVID-19 activity has continued declining in all areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels.
      • “The XEC variant is estimated to comprise 7-16% among circulating viruses as of October 12, 2024. Because XEC is recombined from two JN.1 lineage viruses, the 2024-2025 COVID-19 vaccines that already include JN.1 strains are still expected to provide protection. Similarly, there are no impacts currently expected on tests, treatments, or symptoms at this time. For additional information, please see CDC COVID Data Tracker: Variant Proportions. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • Nationally, RSV activity is low. However, signs of increased RSV activity have been detected in the southeastern U.S., particularly in young children.
    • Vaccination
  • The University of Minnesota’s CIDRAP adds,
    • “CDC wastewater tracking shows that [COVID] viral levels remain low, with levels currently highest in the northeast. The latest data from WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, show that detections are in the medium category nationally, with a downward trend over the last 3 weeks. It said the South and West are currently at the low level.”
  • The AP tells us,
    • “Teen smoking hit an all-time low in the U.S. this year, part of a big drop in the youth use of tobacco overall, the government reported Thursday.
    • “There was a 20% drop in the estimated number of middle and high school students who recently used at least one tobacco product, including cigarettes, electronic cigarettes, nicotine pouches and hookahs. The number went from 2.8 million last year to 2.25 million this year — the lowest since the Centers for Disease Control and Prevention’s key survey began in 1999.
    • “Reaching a 25-year low for youth tobacco product use is an extraordinary milestone for public health,” said Deirdre Lawrence Kittner, director of CDC’s Office on Smoking and Health, in a statement. However, “our mission is far from complete.”
    • “A previously reported drop in vaping largely explains the overall decline in tobacco use from 10% to about 8% of students, health officials said.”
  • The UMN CIDRAP mentions,
    • “Including preset treatment orders in the electronic medical records of children with ear infections dramatically improved compliance with antibiotic treatment guidelines, researchers reported at IDWeek 2024.
    • “In a study conducted at the University of Colorado/Children’s Hospital Colorado, researchers analyzed data on 34,324 children aged 61 days to 18 months who visited emergency and urgent care centers in the health system for acute otitis media (AOM) from January 2019 to September 2023. Their aim was to assess the effectiveness of a bundled intervention for AOM that included an electronic health record (EHR) order set (implemented in April 2021) that pre-selected a 5-day antibiotic course for children 24 months and older and a local clinical care pathway (implemented in December 2022) that encouraged observation and pain management for children with non-severe AOM. 
    • “Presenting author Joana Dimo, DO, a doctoral fellow at the University of Colorado, said the bundle was developed to address a common problem in antibiotic prescribing for AOM: while most cases (up to 75%) resolve without antibiotics, most children receive antibiotics, often for longer than needed.
    • “We noticed at our institution that children were being prescribed a lot of antibiotics for ear infections, and that the duration of antibiotics was longer than we thought necessary,” Dimo said at a press briefing.”
  • Per Fierce Pharma,
    • “After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy.
    • “The FDA on Friday gave Vyloy (zolbetuximab) the thumbs-up as a first-line treatment for adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive.
    • “With the green light, Vyloy becomes the first U.S.-approved anti-CLDN18.2 drug. The transmembrane protein, also known as Claudin-18.2, has become a red-hot target in the oncology field, ginning up interest from the likes of AstraZeneca, Leap Therapeutics, Legend, Moderna and other companies.
    • ‘Friday’s approval specifically covers Vyloy in combination with fluoropyrimidine- and platinum-containing chemotherapy. Patients must have the CLDN18.2 positivity of their tumors confirmed through testing, and, to that end, the FDA has simultaneously approved a new companion diagnostic from Ventana Medical Systems and Roche.”
  • Per BioPharma Dive,
    • “An experimental antibody drug developed by Merck & Co. significantly reduced the incidence of disease due to respiratory syncytial virus infections as well as related hospitalizations in infants, the company said Thursday.
    • “Called clesrovimab, the antibody met all the goals of a Phase 2b/3 study testing it in more than 3,600 healthy pre- and full-term infants. A dose of clesrovimab lowered RSV disease incidence by 60%, and RSV-associated hospitalizations by 84%, compared to placebo through five months post-treatment.
    • “While three RSV vaccines are approved in the U.S. for older adults, only one antibody drug — Sanofi and AstraZeneca’s Beyfortus — is cleared for all infants entering their first RSV season. If approved, clesrovimab would compete with Beyfortus.”
  • and
    • “Gilead will no longer sell its combination drug Trodelvy to treat bladder cancer, announcing Friday it had agreed with the Food and Drug Administration to withdraw it following negative trial results.
    • “The FDA granted Trodelvy accelerated approval for bladder cancer in 2021, based on results that found it shrank tumors in people whose disease had progressed following treatment with chemotherapy and immunotherapies like Merck & Co.’s Keytruda. But a confirmatory study, titled TROPiCS-04, failed to show the medicine helped people live longer.
    • “Trodelvy’s withdrawal is one of several conditional approvals that have been rescinded in recent years, most notably among the “PD-1” class of drugs that includes Keytruda and Bristol Myers Squibb’s Opdivo. The Trodelvy decision, however, came months after negative trial results, a sign the FDA has become more vigilant about resolving so-called “dangling” accelerated approvals.’

From the U.S. healthcare business front,

  • Healthcare Dive tells us,
    • “CVS Health replaced CEO Karen Lynch on Thursday as the healthcare and pharmacy giant’s financial challenges mount.
    • “CVS’ new chief executive is David Joyner, a company veteran who most recently headed up CVS’ pharmacy benefit manager Caremark. Lynch, who held the top spot at CVS since 2021 and previously led insurer Aetna, stepped down “in agreement with the company’s Board of Directors,” according to a release. 
    • “The company also pulled earnings guidance provided last quarter due to higher medical costs in its Aetna health benefits segment. CVS’ stock fell more than 7% in early morning trade Friday following the news.”
  • The Wall Street Journal adds,
    • “Roger Farah, chairman of CVS’s board of directors, will also become executive chair.” * * *
    • “Joyner and Farah said in an interview with the Journal that CVS will now move forward intact. 
    • “We believe that we have a really important part to play in terms of simplifying and delivering a better healthcare experience for this country,” Joyner said. CVS’s assembled assets will allow it “to actually deliver on the promises that we’ve made, and now it’s all about execution.” * * *
    • “CVS will also report that medical costs are still running higher than expected, an issue that has come up in other insurers’ recent reports. Aetna’s medical loss ratio, or the share of premiums spent on healthcare costs, will be around 95.2%, compared with analysts’ expected 91.1%.”
  • Modern Healthcare reports,
    • “Cigna Group has revived efforts to combine with its smaller rival Humana Inc. after merger talks fell apart late last year, according to people familiar with the matter. 
    • “The two health insurance giants have held informal discussions recently about a potential deal, said the people who asked to not be identified because the talks aren’t public. The discussions are in early stages, they added.
    • Cigna is looking to close the sale of its Medicare Advantage business in the coming weeks before committing to any other transactions, one of the people said.
  • Beckers Hospital Review lets us know,
    • “Shifting care from in-person to virtual settings could reduce total medical claims spending by 2.3% to 3.1%, according to an Oct. 17 study from Solera Health.
    • “The research analyzed longitudinal medical claims data from 50 million commercially insured U.S. adults. The study first identified patients eligible for virtual care based on an outpatient visit for a qualifying diagnosis over a six-month period. Researchers then reviewed the previous 12 months of claims to assess whether patients’ conditions were uncomplicated or complex, followed by a 12-month forward analysis to evaluate whether their conditions remained controlled or became uncontrolled after their initial in-person visit. 
    • “According to estimates from CMS on private insurer spending in 2022, this shift to virtual care could result in cost savings of over $50 billion each year.”
  • Per Fierce Healthcare,
    • “Cancer continues to be employers’ biggest treatment cost, driving up healthcare spending. 
    • “Costs for cancer-related medical services and drugs are expected to reach nearly $250 billion in the U.S. by 2030—a 34% increase since 2015, according to a study by the American Association for Cancer Research.
    • “And, while oncology accounts for only 1% of claims volumes, it makes up 15% of the overall employer healthcare spend, according to a report by The Mahoney Group.
    • “Health tech company Color Health is doubling down on its play for employer-sponsored cancer care, building on its work with the American Cancer Society (ACS) to offer comprehensive cancer management.
    • The company developed a fully integrated virtual cancer clinic for employers, unions and health plans that is designed to support individuals from screening and early detection through diagnosis, treatment and survivorship.
    • “Color, a platform for large-scale care delivery, is rolling out its virtual cancer clinic to more than 45 employers, health plans and unions across the country. The offering will be made available to customers starting January 2025.”

Thursday Miscellany

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

From Washington, DC,

  • The Office of Personnel Management tells us,
    • “OPM today released the 2024 OPM Federal Employee Viewpoint Survey (FEVS) results, the largest worldwide survey of government employees that annually tracks how employees view workforce management, policies, and new initiatives. This year’s results show steady improvement in nearly all areas and the highest-ever Employee Engagement Index (EEI) score since OPM began tracking the metric in 2010. The EEI assesses the critical aspects of an engaged workforce including perception of leadership, supervisors, and intrinsic work experience.” * * *
    • “For the full collection of data, see the OPM FEVS dashboard. This tool provides the public with a dynamic way to access and visualize governmentwide and agency-size survey results and trends of the past five years. New content in the 2024 dashboard release features inclusion of results by Federal Executive Board region and will enhance each Board’s ability to address specific challenges within their geographical area.   
    • “For more information on OPM FEVS methods, see the OPM FEVS Technical Report.”   
  • Federal News Network adds,
    • Many federal human capital experts have said receiving the results of FEVS each year is only the first step for long-term workforce planning. To actually make improvements for their employees, experts say agency leaders have to then analyze the FEVS results and make adjustments as necessary. Later this fall, the Chief Human Capital Officers (CHCO) Council plans to publish a FEVS “toolkit” including recommendations for how leaders can make changes based on FEVS, as well as strategies for action planning and better communication with employees.”
  • Tammy Flanagan, writing in Govexec, points out ten important facts about Medicare that folks approach age 65 need to know.
  • Federal News Network is offering a Federal Benefits Open Season feature
  • The American Hospital Association News lets us know,
    • “A report released Oct. 17 by the Senate Homeland Security Committee’s investigative subcommittee scrutinizes some of the nation’s largest Medicare Advantage insurers for their use of prior authorization and high rates of denials for certain types of care. The subcommittee sought documents and information from the three largest MA insurance companies — UnitedHealthcare, Humana and CVS — and investigated their practice of “intentionally using prior authorization to boost profits by targeting costly yet critical stays in post-acute care facilities.”  
    • “The report found that between 2019 and 2022, UHC, Humana and CVS denied prior authorization requests for post-acute care at far higher rates than other types of care. In 2022, UHC and CVS denied prior authorization requests for post-acute care at approximately three times higher than the companies’ overall denial rates, while Humana’s prior authorization denial rate for post-acute care was more than 16 times higher than its overall denial rate. The report also found increases in post-acute care service requests subjected to prior authorization and denial rates for long-term acute care hospitals, among other findings.”
  • In the past, such practices were praised as cost containment, a now forgotten policy.
  • Thompson Reuters delves into “HHS FAQs [that] elaborate on HIPAA Administrative Simplification Enforcement and Compliance.”

From the public health and medical research front,

  • The Washington Post reports the latest news about the ongoing massive meat recall over a Listeria concern.
    • The recalled products include about 11,765,285 pounds of ready-to-eat meat and poultry items [prepared by BrucePac] that have been sold at stores across the country, including Walmart, Target, Aldi, Trader Joe’s, Kroger, Publix, Wegmans and more.
    • Initially, the [USDA Food Safety and Inspection Service] FSIS said the recalled goods have the establishment numbers 51205 or P-51205 inside or under the USDA mark of inspection on their labels, but it cautioned later that some recalled products could bear a different number “due to further distribution and processing by other establishments.”
    • The FSIS is encouraging consumers to review a more than 340-page list of labels and products included in the recall. The list has images of labels with 7-Eleven, Amazon Kitchen, Boston Market, Dole, Taylor Farms, Giant Eagle and ReadyMeals branding, among several other name brands.
    • Among the recalled items are chicken-based salad bowls, wraps, sandwiches, burritos and pastas.
    • In an Oct. 15 update, the FSIS said that the recalled foods had been distributed to schools, in addition to restaurants and institutions, but that a school distribution list was not yet available. “These products should be thrown away or returned to the place of purchase,” it said.
  • The NIH Director Dr. Monica Bertagnolli writes in her blog,
    • “Proteins are vital to our bodies. They serve as structural building blocks for our tissues and organs and are responsible for their functioning in both health and disease. Genes, like recipes, contain instructions for making proteins. Usually, each essential protein is produced from a single gene. Now, new research shows that some bacteria can actually produce two or more proteins from a single gene by “flipping” underlying stretches of DNA.
    • “While scientists have long known that DNA inversions can occur in bacteria, this study is the first to describe these inversions, or “invertons,” within individual genes. What’s more, the findings, from research supported by NIH and reported in the journal Nature , suggest that this flipping happens more often than scientists suspected.
    • “The findings, from Ami S. Bhatt at Stanford Medical School in Stanford, CA, and her colleagues, may have important implications, not only for bacteria, but also for human health. For example, bacteria’s ability to flip genes and alter proteins on their surfaces may restrict the ability of our immune systems to recognize and effectively respond to infectious microbes. Invertons also likely play roles in how our microbiomes, the communities of microorganisms that live in and on us, develop and change within our bodies. Our microbiomes influence our metabolisms, immune responses, and more. * * *
    • “The researchers now want to investigate the mechanisms causing inversions. They expect that these findings are just the tip of the iceberg for understanding the role of invertons in bacteria’s ability to adapt and thrive. They also suggest that, as we learn more about links between this process in bacteria and human diseases, we might find ways to harness it for improving human health.”
  • The Wall Street Journal reports,
    • “Feel like it takes longer to recover from everything these days—whether it’s an injury or poor sleep? That’s the reality of what time is doing to our bodies.
    • “Researchers call our ability to bounce back from health stress “biological resilience.” Evidence suggests that it declines with age, driven by biological and other factors, including parenting, work stress, changes in exercise habits and menopause.
    • “Often, these stresses pile up from early life and can reach a tipping point in our 30s and 40s. 
    • “There are these moments where the whole system seems to undergo like a vibe shift,” says Dr. Heather Whitson, a geriatrician and clinical investigator who directs the Duke University Aging Center.
    • “These midlife declines in resilience parallel emerging science suggesting that aging itself doesn’t happen in a linear way, doctors and researchers say. A small study out of Stanford that looked at biomolecular shifts in the body found two aging “waves” appear to occur around ages 44 and 60. 
    • “While the Stanford study’s findings are difficult to generalize to the broader adult population, family-medicine doctors report seeing similar age-related changes in their patients. The first shift often happens for patients in their late 30s and early 40s, says Dr. Benjamin Missick, family medicine doctor at Novant Health in North Carolina.”
  • and
    • “Drugs such as Novo Nordisk’s blockbuster Ozempic can cut drug and alcohol abuse by up to 50% according to a new study, adding to mounting evidence that the drugs yield health benefits beyond diabetes and weight loss.
    • “In a study published Thursday in scientific journal Addiction, around 500,000 people with a history of opioid use disorder were analyzed, of which just more than 8,000 were taking either GLP-1 drugs such as Ozempic or the similar GIP class of drugs that Eli Lilly’s Mounjaro belongs to.
    • “GLP-1 drugs work by mimicking a gut hormone to control blood sugar and suppress appetite while GIP medications take a dual-target approach by mimicking both the GLP-1 hormone and a second gut hormone that is believed to enhance the drug’s effectiveness.
    • “The study found that those taking the drugs had a 40% lower rate of opioid overdose compared with those who didn’t.
    • “Similarly, an analysis of more than 5,600 people with a history of alcohol use disorder and who took the drugs showed they had a 50% lower rate of intoxication compared with those who didn’t take them.
    • “Our study… reveals the possibilities of a novel therapeutic pathway in substance use treatment,” the study’s lead researcher Fares Qeadan and co-authors of the research report Ashlie McCunn and Benjamin Tingey said.
  • Per BioPharma Dive,
    • “People with advanced Parkinson’s disease have a new treatment option, as the Food and Drug Administration on Thursday approved a combination therapy from AbbVie that’s designed to provide longer-lasting movement control.
    • “Parkinson’s is hallmarked by unintentional muscle movements like shaking or stiffness — the result of nerve cells progressively breaking down and dying. Two drugs, carbidopa and levodopa, have become mainstay treatments for the motor symptoms associated with the disease. AbbVie’s now-approved Vyalev pairs these medications together, but in a unique way.
    • “Vyalev uses “prodrug” versions of carbidopa and levodopa, meaning their therapeutic effects aren’t felt until they’re metabolized. Additionally, Vyalev is the first and only levodopa-based therapy given as a 24-hour infusion, similar to an insulin pump. That could be particularly useful for people with advanced Parkinson’s, who often have trouble swallowing pills because of their impaired motor function.”
  • HCP Live relates,
    • Low-dose oral food challenges in infants with allergies are safe, with skin symptoms as the most common reaction, and no cases of anaphylaxis reported.
    • The study supports early introduction of allergenic foods to build tolerance, aligning with guidelines for early peanut introduction.
  • Beckers Clinical Research notes,
    • “University of Pennsylvania and Children’s Hospital of Philadelphia researchers have developed the first mRNA Clostridioides difficile vaccine — and it’s shown promising results in animal models.
    • “The mRNA vaccine was found to protect against first-time C. diff infections and relapsing infections, promote clearance of existing C. diff bacteria in the gut and overcome deficits in host immunity to protect animals from infection, according to an Oct. 17 system news release. The study was published in Science and could pave the way for clinical trials.
    • “Researchers used the mRNA-LNP vaccine platform — the same that provided the COVID-19 vaccines — to create the C. diff vaccine.” 

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Elevance Health lowered its profit guidance for 2024 on Thursday as the insurer manages “unprecedented challenges” in its Medicaid business.
    • “The company expects net income per diluted share to be approximately $26.50, down from at least $34.05 it projected last quarter. 
    • “But CEO Gail Boudreaux said the increased costs pressuring its Medicaid segment would alleviate as states updated their payment rates to better match member acuity. “We remain confident in the long-term earnings potential of our diverse businesses as we navigate a dynamic operating environment and unprecedented challenges in the Medicaid business,” she said in a statement.” 
  • Modern Healthcare adds
    • “Elevance Health took a hit on its Medicare Advantage star ratings for 2025 and plans to do something about it, President and CEO Gail Boudreaux told investor analysts Thursday.
    • “The for-profit Blue Cross and Blue Shield licensee is the latest Medicare Advantage insurer to push back on the lower quality scores the Centers for Medicare and Medicaid Services announced last week. UnitedHealthcare parent company UnitedHealth Group already sued the agency and Humana is appealing to CMS before taking other actions.
    • “We have challenged our initial score with CMS and are considering all of our options,” Boudreaux said when announcing the company’s third-quarter financial results.”
  • Fierce Healthcare tells us,
    • “Evernorth has tapped Transcarent to power its Oncology Benefit Services offering, which aims to offer end-to-end support for cancer patients for the course of their care journey.
    • “The companies announced Thursday that the program is built on a digital platform that unites key cancer services across the patients’ medical and pharmacy benefits and connects them to a dedicated care team for personalized support and outreach.
    • “This digital platform makes it easier for employers to offer a “streamlined” experience to workers, according to the announcement. Through it, members can reach dedicated oncology nurse navigators who have an American Cancer Society Leadership in Oncology Navigation (ACS LION) certification, find and schedule appointments with cancer centers of excellence, connect to virtual care or have key drug consultations.
    • “Nurse navigators are also trained to provide support to the patients’ caregivers. They’re able to provide educational materials, assistance in appointment scheduling and answers to key questions.”
  • Beckers Hospital Review points out,
    • “Changing consumer trends and market dynamics are leading to hundreds of pharmacy store closures in the U.S.
    • “Brick-and-mortar locations are losing to mail-order and digital options, according to a J.D. Power study of pharmacy customers. Between 2023 and 2024, overall customer satisfaction in physical drug stores declined 10 points on a 1,000-point scale, and satisfaction scores for mail-order pharmacies increased six points.” 
  • “Deloitte research indicates that by ensuring virtual health offerings prioritize convenience and address consumer preferences, health systems could gain a competitive advantage.”
  • Per MedTech Dive,
    • “CMR Surgical won Food and Drug Administration authorization for its Versius robot with an initial indication for gallbladder removal surgery. CMR will partner with select hospitals as the first part of a multistage strategic plan to introduce the robot in the U.S.
    • “The authorization is the first granted through the FDA’s de novo pathway for a multiport, soft tissue general surgical robot, CMR said in a Monday announcement. The de novo process brings new medical devices to market that may serve as predicates for other 510(k) submissions.
    • “The company announced the milestone less than a week after it named Massimiliano Colella as interim CEO, replacing Supratim Bose, who stepped down for personal reasons after less than two years in the job.” 

Midweek update

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, Medical / Rx research, NIH, OPM, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Tomasz Filipek on Unsplash

From Washington, DC,

  • NBC News informs us,
    • “House Republicans on Wednesday defeated their own plan to avert a government shutdown at the end of the month, with the party divided over the length of a short-term funding bill and what, if anything, should be attached to it.
    • “It was an embarrassing blow to Speaker Mike Johnson, R-La., who had yanked the same funding package off the floor last week amid growing GOP defections, only to watch it collapse on Wednesday in a vote that seemed doomed from the start.
    • “The vote was 202-220 with two members voting present. In all, fourteen Republicans voted against the package and three Democrats voted for it.
    • “Thirteen days before money runs out for the federal government, there is still no bipartisan plan to stave off a shutdown. While the GOP-led House could try again, the focus now likely shifts to the Senate, where leaders in both parties agree a shutdown would be disastrous weeks before the election.”
  • Govexec adds,
    • “Legislation to cover a $3 billion shortfall in veterans’ benefits through the end of the month passed the House Tuesday, three days before benefits could be disrupted.  
    • “Lawmakers passed the Veterans Benefits Continuity and Accountability Supplemental Appropriations Act by voice vote Tuesday evening, sending it to the Senate ahead of a Friday deadline to ensure the Veterans Affairs Department can process benefit payments for 7 million veterans. * * *
    • “Senate Veterans’ Affairs Committee Chairman Jon Tester, D-Mont., said in a statement Tuesday that it was critical that the Senate move with haste to pass the legislation.”
  • STAT News reports,
    • “A House committee on Wednesday advanced legislation that would extend Medicare telehealth flexibilities, and a home hospital program adopted during the pandemic, the final step before the bills face a vote by the full House of Representatives.
    • “Congress in 2022 extended pandemic-era flexibilities about where and what kinds of care Medicare enrollees could receive over telehealth. The two-year telehealth extension unanimously passed on Wednesday by the House Energy & Commerce Committee is very similar to bills advanced in May by Commerce’s health subcommittee and the House Ways & Means Committee. 
    • “The two bills set up the House position heading into negotiations with the Senate on extending the telehealth policies, which expire at the end of December.” 
  • Per Federal News Network,
    • “House Democrats are pushing harder to try to help federal employees more easily access IVF treatments. A new bill, called the Right to IVF Act, rolls together four previous bills all aiming to broaden fertility coverage nationwide. Part of the legislation would require carriers in the Federal Employees Health Benefits Program to increase their coverage of IVF for FEHB enrollees. The Democrats who introduced the bill are calling for a House floor vote, but so far, the legislation has no Republican co-sponsors.(Right to IVF Act – Reps. Gerry Connolly (D-Va.), Susan Wild (D-Pa.), Rick Larsen (D-Wash.) and Rosa DeLauro (D-Conn.))”
  • and
    • “Federal benefits for health and retirement are a major recruitment and retention influence for employees, especially for early-career talent.
    • “Women as well as individuals in younger generations ranked the importance of federal benefits more highly than older or male employees, according to the results of the 2023 Federal Employee Benefits Survey (FEBS) from the Office of Personnel Management, obtained exclusively by Federal News Network.
    • “The benefits stemming from the Federal Employees Health Benefits (FEHB) program and the paid parental leave program are particularly important to younger generations of employees, OPM’s survey showed. Specifically, 94% of millennial and Gen Z respondents said the FEHB was either “important” or “extremely important” to them, compared with 84% of baby boomers and older generations who gave the same response.
    • “It is clear that these major benefit programs have an impact on both recruiting and retaining talent in the federal government, making it critical to continuously improve these benefits to meet employee needs,” OPM wrote in the survey results.”
  • A commentator writing in Real Clear Health commends the FEHB Program for being a catalyst for change in women’s health care and suggests three improvements:
    • Provide solutions for perimenopause and menopause
    • Provide a safety net for caregivers, and
    • Provide enhanced family planning and maternal care.
  • Mercer Consulting offers FAQs on the Supreme Court’s recent Loper Bright decision.
    • “The US Supreme Court overturned a 40-year-old principle of administrative law known as the Chevron deference doctrine (Loper Bright Enterprises et al. v. Raimondo, Secretary of Commerce, et al.). That doctrine required courts to defer to administrative agencies’ reasonable interpretation of a federal law that is silent or ambiguous. Now, federal courts must exercise independent judgment when determining the best interpretation of a statute and cannot simply defer to agency interpretations, even when they are reasonable. This will likely increase courts’ scrutiny of federal agency regulations that are subject to legal challenges. These FAQs provide high-level information about the case and its potential impact on employee benefit plans and their sponsors. Also, this Mercer US Health News 15-minute video highlights the practical implications of this opinion on employer-sponsored health plans.”

From the public health and medical research front,

  • MedPage Today lets us know,
    • “The new COVID-19 variant XEC may overtake others in circulation to become dominant in the coming months, experts said but will not prompt a meaningful change in symptoms or vaccine response.” * * *
    • “XEC represents a fairly minor evolution relative to the SARS-CoV-2 diversity currently in circulation, and is not a highly derived novel variant such as those that were granted Greek letters,” like Alpha, Delta, and Omicron, Francois Balloux, PhD, a computational biologist at University College London and director of the UCL Genetics Institute, said in a Science Media Centre statement.
    • “Experts noted that while XEC may have a small advantage in transmission, available vaccines are still likely to provide protection from serious illness.
    • “XEC is a “recombinant variant of some of the other Omicron lineages that have been around for a while, and it does appear to be more immune evasive, giving it a transmissibility advantage in the population with the immunity that it has,” Amesh Adalja, MD, of the Johns Hopkins Center for Health Security in Baltimore, told MedPage Today. “But it doesn’t really change anything, just like the last variant didn’t change anything, or the one before that, one before that, or the one before that.”
  • NBC New points out,
    • “Black women are more likely than white women to die from even the most treatable types of breast cancer, a study published Tuesday in the Journal of Clinical Oncology found.
    • “The findings, experts say, underscore that it’s racial disparities, not biology, driving the biggest differences in death rates between Black and white women. While Black women and white women are diagnosed with breast cancer at similar rates, Black women are 40% more likely to die from the disease.” * * *
    • “If you look at breast cancer data from 40 years ago, there really weren’t differences in mortality for breast cancer between Black and white women. We weren’t very good at treating and diagnosing it. But as we’ve gotten better, the gap between white and Black women has grown,” [lead author Dr. Erica] Warner said. “That is problematic, but that also tells us we have our foot on the pedal for these differences. If we can create them, we can eliminate them.” 
  • STAT News reports,
    • “A long-running race to develop a gene therapy for the most common cause of age-related blindness is heating up.
    • “On Wednesday, 4D Molecular Therapeutics announced new data from its program for the disease, known as wet age-related macular degeneration, or wet-AMD. In one 30-person Phase 2 study, patients’ need for standard-of-care injections fell by 89% after receiving gene therapy, and 73% did not need another standard-of-care shot for at least 32 weeks. 
    • “Notably, only two of 71 patients who received a high dose of therapy have shown signs of ocular inflammation, 4D said. In 2021, another leading contender, Adverum, was set back after a patient with a related disease went blind in one eye. 
    • “I think it’s very positive and there’s a good chance they’ll be able to move toward approval,” said Ron Crystal, chair of genetic medicine at Weill Cornell Medical Hospital, who has served as a scientific adviser to and has stock in Adverum.”
  • The New York Times notes,
    • “Adults under age 50 have been developing breast cancer and colorectal cancer at increasingly higher rates over the last few decades, and alcohol use may be one factor driving the trend, according to a scientific report published on Wednesday.
    • “The report, by the American Association for Cancer Research, highlights scientific breakthroughs that have led to new anticancer drugs and improved overall survival.
    • “But the authors also described a troubling pattern: Even as cancer death rates have declined, the overall incidence of several cancers has been rising inexplicably, with an especially alarming increase among younger adults in cancers of the gastrointestinal system, like colorectal cancer.
    • “The report estimates that 40 percent of all cancer cases are associated with modifiable risk factors. It recommends reducing alcohol consumption, along with making lifestyle changes such as avoiding tobacco, maintaining a healthy diet and weight, exercising, avoiding ultraviolet radiation and minimizing exposure to pollutants.”
  • Per NIH press releases,
    • “Results from a large study supported by the National Institutes of Health show that protein analyses taken during the first trimester of pregnancy did not improve predictions for identifying people at risk for experiencing conditions related to having high blood pressure during pregnancy. Since there is an urgent need to better predict people at risk for developing conditions related to having high blood pressure during pregnancy, also called hypertensive disorders of pregnancy, researchers have been studying if proteins taken from blood or urine samples could provide this insight. This study provides the largest data to date based on using protein analyses from blood samples during early pregnancy.”
  • and
    • “Researchers at the National Institutes of Health (NIH) and their collaborators have identified a protein, known as RNF114, that reverses cataracts, a clouding of the eye’s lens that occurs commonly in people as they age. The study, which was conducted in the 13-lined ground squirrel and rats, may represent a possible surgery-free strategy for managing cataracts, a common cause of vision loss.  The study published in the Journal of Clinical Investigation.
    • “Scientists have long searched for an alternative to cataract surgery, which is effective, but not without risk. Lack of access to cataract surgery is a barrier to care in some parts of the world, causing untreated cataracts to be a leading cause of blindness worldwide,” said Xingchao Shentu, M.D., a cataract surgeon and the co-lead investigator from Zhejiang University, China.” * * *
    • “According to the scientific team, these findings are proof-of-principle that it is possible to induce cataract clearance in animals. In future studies, the process will need to be fine-tuned so scientists can stimulate specific protein degradation to see how to precisely regulate protein stability and turnover. This mechanism is also an important factor in many neurodegenerative diseases, they said.”
  • and
    • “A clinical trial supported by the National Institutes of Health (NIH) was stopped early after researchers found sufficient evidence that a drug used to treat bone marrow cancer and Kaposi sarcoma is safe and effective in treating hereditary hemorrhagic telangiectasia (HHT), a rare bleeding disorder that affects 1 in 5,000 people worldwide. The trial results, which are published in the New England Journal of Medicine, detail how patients with HHT given the drug, called pomalidomide, experienced a significant reduction in the severity of nosebleeds, needed fewer of the blood transfusions and iron infusions that HHT often demands, and showed improved quality of life.
    • “Finding a therapeutic agent that works in a rare disorder is highly uncommon, so this is a real success story,” said Andrei Kindzelski, M.D., Ph.D., of NIH’s National Heart, Lung, and Blood Institute. “Before our trial, there was no reliable therapeutic to treat people with HHT. This discovery will give people who suffer with this disease a positive outlook and better quality of life.”

From the U.S. healthcare business front,

  • Per Beckers Hospital Review,
    • “St.-Louis-based Ascension reported a $79 million operating loss (-0.3% margin) for the 10 months ending April 30, a substantial improvement on the $1.2 billion operating loss in the previous 10-month period. 
    • “The results include $402 million in one-time, non-cash write-downs and non-recurring losses.
    • “In May and June 2024, operations were hampered by the May ransomware attack, resulting in reduced revenues from the associated business interruption along with costs incurred to address the issues and other business-related expenses.
    • “Despite this incident, Ascension drove a $1.2 billion operational improvement year over year for the 10 months ending April 30. The 136-hospital system’s economic improvement plans focused on volume growth, rates and pricing, and cost levers. 
    • “The results are a notable improvement on the $3 billion operating loss (-5.5% margin) reported in fiscal year 2023. Including the cyberattack, Ascension reported a $1.8 billion (-4.9% margin) loss in FY 2024. 
    • “Ascension is also reorganizing its portfolio with several transactions in multiple markets.”
  • Healthcare Dive tells us,
    • “Community Health Systems’ Northwest Urgent Care has signed a definitive agreement to purchase 10 Arizona urgent care centers from Carbon Health for an undisclosed price, according to a press release this week.
    • “The acquisition, which is expected to close in the fourth quarter, will grow CHS’ integrated health network to more than 80 care sites in the Tucson, Arizona region, according to CHS.
    • “The acquisition is a reversal from CHS’ recent string of hospital divestitures, which have been integral to helping the operator deleverage its portfolio.”
  • Per BioPharma Dive,
    • “Organon has agreed to buy Roivant’s dermatology subsidiary Dermavant for $175 million upfront plus more than $1 billion in potential additional payments if certain milestones are hit.
    • “With the acquisition, Organon will gain Dermavant’s cream called Vtama, which was approved in 2022 to treat plaque psoriasis. The medicine is also awaiting action from the Food and Drug Administration that could expand its use to include atopic dermatitis, commonly known as eczema.
    • “Approval in eczema, expected in the fourth quarter, would trigger a $75 million payment, Organon said Wednesday. The deal also includes $950 million in potential commercial milestone payments as well as tiered royalties on net sales to Dermavant shareholders. Roivant owns the majority of Dermavant.”
  • Fierce Healthcare points out,
    • “If a patient receives a continuous glucose monitor device through their medical benefit, they may be more adherent and may have lower costs, according to a new analysis.
    • “Researchers at CCS, which offers clinical services and home delivery for medical supplies for people with chronic conditions, published the peer-reviewed study this week in the Journal of Medical Internet Research Diabetes (JMIR) and found that patients who secured the monitors through their medical coverage had 23% higher rates of adherence.
    • “The study included data on 2,356 people, with 1,178 in the pharmacy benefit group and 1,178 in the durable medical equipment cohort. In addition to greater adherence, the study found that people who received the devices through their medical benefit had 35% lower average annual total costs of care.
    • “And, for patients who were not adherent to their devices, there was a higher rate of reinitiation (22%) for those in the medical benefit compared to those who received the glucose monitors through their pharmacy benefit (11%).”
  • Per MedTech Dive,
    • “Zimmer Biomet will phase out sales of its CPT Hip System by December due to concerns about the risk of thigh bone fractures, the Food and Drug Administration said in a Tuesday notice. 
    • “Despite plans to pull the device, the FDA said it is still concerned about the hip system being implanted in new patients, and it is “working with the manufacturer to address these concerns.” 
    • “Earlier this month, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) flagged a higher risk of thigh bone fracture after surgery with the CPT Hip System, compared with similar hip replacement devices. While the analysis is currently unpublished, the British Hip Society and the British Orthopaedic Association advised against using the implant for elective surgery unless in exceptional circumstances.”