Thursday Miscellany

CDC

Thursday Miscellany

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “Susie Wiles, who led Donald Trump’s presidential run, will become his White House chief of staff when he retakes the presidency next year, the campaign said Thursday, making her the first woman to hold that role in U.S. history. * * *”
    • “Those who have worked with her say she is unflappable behind her trademark mirrored sunglasses, avoids the limelight and is quick to give her team credit for her stack of victories.
    • “Every campaign she’s been involved with, she’s been a calming presence,” longtime Florida lobbyist and Wiles ally Brian Ballard told the Journal. “He saw in her the DNA of a winner.”
  • Federal News Network interviews principal Thiago Glieger, a principal of RMG Advisors about getting organized for the Federal Employee Benefits Open Season, which starts next Monday.
  • The Wall Street Journal reports,
    • “U.S. health officials proposed banning an ingredient used in popular oral decongestants, a step toward removing dozens of cold medicines from store shelves. 
    • “The Food and Drug Administration on Thursday proposed removing the ingredient, known as oral phenylephrine, from its list of approved over-the-counter ingredients after determining the drug doesn’t work at relieving stuffy noses.
    • “The agency took action after The Wall Street Journal had reported that some recent studies found oral phenylephrine in certain medicines was ineffective at relieving nasal congestion. CVS Health had already said it would pull some decongestants containing phenylephrine and no longer sell them. 
    • “After taking public comment, the FDA could issue a final decision that would end sales of medicines containing the ingredient, including certain versions of Benadryl, Mucinex and Tylenol. The agency said it would give drugmakers time to remove the products from the market or reformulate them. 
    • “The earliest a potential ban would take effect is 2026.
    • “Instead of taking pills that contain phenylephrine to clear congestion, people can take pills made from pseudoephedrine, antihistamines or nasal sprays, including those with phenylephrine. Physicians and pharmacists say the alternatives are effective.”
  • Beckers Hospital Review adds,
    • “The FDA has updated the labels for all GLP-1 receptor agonists, including popular medications Ozempic, Wegovy, Saxenda and Mounjaro, to include a new warning about the risk of pulmonary aspiration during general anesthesia or deep sedation, Medscape reported Nov. 6. 
    • “The updated warning, issued Nov. 5, stems from rare postmarketing reports of patients who experienced pulmonary aspiration, when food or liquid enters the lungs, while undergoing elective surgeries or procedures requiring anesthesia despite following fasting guidelines prior to surgery.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS) released the 2021–2023 Progress Report – PDF for the Sexually Transmitted Infections National Strategic Plan for the United States: 2021–2025. The progress report provides a high-level overview of progress on select federal agency programs, policies, research, and other activities during fiscal years 2021–2023.”
    • “The progress report features an at-a-glance table of the status of seven core indicators and seven disparities indicators, which were identified in the national plan as a quantitative approach to measuring progress on STI prevention and care in the United States. The most recently available data reveal that seven of the indicators have met or are moving toward annual targets and that seven have not met or are moving away from annual targets. Of this latter group, six indicators relate to syphilis, which is the focus of the National Syphilis and Congenital Syphilis Syndemic Federal Task Force led by HHS Assistant Secretary for Health, Admiral Rachel Levine, M.D.”

From the public health and medical research front,

  • Health Day tells us,
    • “Nearly 16% of American adults — that’s close to 1 in 6 — now has diabetes, according to the latest data from the U.S. Centers for Disease Control and Prevention.
    • “Increasing age and widening waistlines greatly increase the odds for the disease, which happens when the body doesn’t use insulin properly, resulting in high blood sugar levels. If left unchecked, diabetes can be disabling and even life-threatening.
    • “The vast majority (95%) of diabetes cases are type 2 diabetes, which occurs when the body’s cells no longer respond to insulin as they should. Insulin regulates levels of sugar in the blood. Type 2 diabetes is strongly connected to excessive weight. 
    • “The new data, collected from mid-2021 through mid-2023, found a big rise in diabetes rates since 1999-2000, when 9.7% of adult Americans had the disease.
    • ‘There was a significant gender gap in diabetes rates in 2023: Nearly 1 in 5 men (18%) have the illness, compared to 13.7% of women, according to researchers at the CDC’s National Center for Health Statistics (NCHS).”
  • and
    • “A simple nasal swab might help doctors predict the severity of a person’s COVID infection, a new study suggests.
    • “More than 70% of people with mild or moderate COVID develop certain antibodies in their nasal cavities that are linked to fewer symptoms, better immune response and faster recovery, researchers reported Nov. 6 in the journal Science Translational Medicine. * * *
    • “Researchers are working on a nasal swab test that could be used to predict how bad a person’s COVID infection will prove to be.
    • “Right now, we’re either looking at infection risk before it happens or analyzing the infection course well after recovery,” said researcher Ben Babcock, a doctoral candidate at Emory. “Imagine if we could capture the immune response in real time, right in the clinic. A just-in-time test could give physicians and patients the real-time information they need to make faster, smarter treatment decisions.”
  • STAT News informs us,
    • “For months, as human cases of H5N1 bird flu associated with an outbreak of the virus in U.S. dairy cattle have mounted, one question has loomed larger than others: how many human infections are getting missed?
    • “Farmworkers face some of the most intense exposure to the bird flu virus, but resistance from farmers and a lack of health insurance and paid sick leave in the industry have limited the amount of testing of workers and hampered public health officials’ ability to track where the virus might be spreading. Now, long-awaited results from blood testing conducted by the Centers for Disease Control and Prevention are starting to fill in the picture.
    • “The findings, published Thursday, suggest that a small but not insignificant number of H5N1 infections are going undetected among people who work with dairy cows. Blood samples taken from 115 farm workers in Michigan and Colorado over the summer found evidence of a recent infection in eight individuals — half of whom recalled being ill around the same time the cows were sick. The other half could not recall having any symptoms.
    • “Known as serological surveys, the studies involve fishing out antibodies in the blood — molecules made by the immune system in response to a pathogen’s attack that persist long after an infection is over. Finding them is a signal of past contact with a particular virus and helps scientists understand how widely it has spread. 
    • “While the new results suggest that current public health efforts are missing cases, they do not indicate that the strain of H5N1 associated with the dairy cattle outbreak has gained the ability to spread from person to person.”  
  • NBC News reports,
    • “Brie and camembert that may potentially be contaminated with listeria are being recalled, the latest in a series of food incidents in the U.S. in recent months.
    • “Savencia Cheese USA is recalling select soft ripened cheeses after routine testing found the processing equipment at the company’s Lena, Illinois, manufacturing facility may have been contaminated with the bacteria.
    • “Aldi and Market Basket, a supermarket chain in New England, are among stores that sell the cheeses, but the recalled products only had “limited regional distribution” in the U.S., according to the U.S. Food and Drug Administration. 
    • “The “few retailers” that received them have been informed of the possible contamination and are removing products from shelves, the FDA added.
    • “There are no confirmed reports of anyone getting sick so far, the agency noted.”
  • NIH Director Dr. Monica Bertagnolli writes in her blog,
    • “Digestion involves much more than just your stomach. The digestive process that fuels your body begins in your mouth each time you take a bite of food and chew. An enzyme in your saliva, called amylase, then starts to break down complex carbohydrates—or starches found in many fruits, vegetables, and grains—into simpler sugars to give you their sweet flavor followed by a burst of energy.
    • “Amylase is the reason we’re so good at turning starch into calories, but it isn’t the same for everyone. There’s plenty of genetic variation in the number of salivary amylase genes (AMY1) our cells carry and, therefore, in how much of this essential starch-busting enzyme people have. Studies have suggested a link between changes in amylase gene copy numbers over time and both the rise of agriculture and starch-heavy diets. Now a study in Science , supported in part by NIH, suggests that extra copies of AMY1 are not only connected to our ability to effectively digest carbs, but also may be more ancient than previously known, arising even before modern humans split from Neanderthals and long before the advent of farming.” * * *
    • ‘The researchers compared the modern-day amylase genes to publicly available DNA sequences from 68 ancient human samples obtained from preserved remains. This revealed that ancient hunter-gatherers already had six to eight AMY1 copies long before people started growing crops and eating high amounts of starch. In fact, genetic variation underlying the production of this enzyme had already spread across Eurasia as far back as 45,000 years ago. However, the new analyses do show an increase in amylase gene copy numbers in the last 4,000 years, as people took up farming.
    • “The study team went on to uncover evidence that the expansion of amylase genes apparently has a longer history than anyone had suspected. Intriguingly, they found three copies of AMY1 in the DNA of three of six Neanderthals and one Denisovan. Neanderthals and Denisovans are both extinct relatives of early humans. The findings suggest that an extra copy of the amylase gene may have arisen as long as 800,000 years ago. The researchers also described how those first extra AMY1 copies could lead to their continued duplications or deletions to produce the wide variation in amylase gene copy numbers seen among modern humans.
    • “This variation in amylase genes would have afforded our ancestors dietary flexibility, allowing them to adapt as diets changed over time. But these discoveries aren’t only fascinating from an evolutionary or historical point of view. They may also lead to new understandings of genetic differences among people today, with potentially important implications for our metabolisms, nutrition, and health.”
  • The Washington Post reports,
    • “Regular practice of yoga can reduce lower-back pain, improve sleep and lessen reliance on pain medication, according to a study conducted by Cleveland Clinic researchers.
    • “The randomized clinical trial studied 140 Cleveland Clinic employees who had disclosed moderate amounts of pain for at least three months. Participants who engaged in a 12-week virtual yoga program reported feeling less pain and better sleep when compared with those who did not have access to the program.”

From the U.S. healthcare business front,

  • Modern Healthcare lets us know,
    • “Private equity firms are shifting their focus from providers to healthcare information technology and pharmaceutical services.
    • “State and federal regulatory scrutiny has deterred private equity investment in healthcare providers, PitchBook analysts said in the company’s latest healthcare services report. But regulatory oversight of healthcare-related private equity deals has slightly cooled as certain state bills stalled in the 2024 legislative session, and the report says analysts expect more private equity activity through the rest of the year.”
  • The American Hospital Association News relates,
    • “Baxter expects to restart a second IV solutions manufacturing line within the next week, the company announced Nov. 7. Along with the first line that resumed production last week, the two lines comprise approximately 50% of the North Cove, N.C., site’s total pre-Hurricane Helene production of IV solutions and about 85% of one-liter solutions production. Hospitals in clinics most commonly use the one-liter solutions. The earliest the facility could begin shipments is late this month.
    • “The company said they expect their peritoneal dialysis and irrigation solutions lines to be the next to resume production and would begin by early December. Baxter expects all lines to restart by the end of the year but does not have a timeline on when total production will return to pre-hurricane levels. The company also said today that it has evaluated and approved more than 200 allocation exception requests to support the neonatal and pediatric patient needs.
    • “In addition, Baxter announced that a second temporary bridge has been installed at the plant and is in use. The bridge will allow traffic for additional trucks and equipment. The first bridge so far has allowed transport of more than 1,000 truckloads of products, Baxter said. Prior to the hurricane, the plant had manufactured approximately 60% — or 1.5 million bags or 95 truckloads — of IV solution used every day in the U.S.”
  • Beckers Payer Issues ranks the largest payers by 3rd quarter profits.
  • Per Fierce Healthcare,
    • “CerpassRx, an independent pharmacy benefit manager, is teaming up with Waltz Health to launch a new AI-powered tool that aims to better manage specialty drug spending.
    • “Called Intelligent Specialty Engine, the tool leans on Waltz’s capabilities to offer clients real-time data analytics and management options that are designed to drive down spending, create greater transparency and improve the experience for both the patient and the plan sponsor.
    • “The PBM said that the platform is a “unique deployment” of Waltz Health’s Waltz Connect platform, which connects users to a network of both national and regional pharmacies that compete on price. It uses AI to help steer patients to “the most cost-effective and clinically appropriate pharmacies.”
  • Per BioPharma Dive,
    • “Sarepta Therapeutics is giving up on an experimental drug for Duchenne muscular dystrophy as sales rocket for its approved gene therapy for the disease.
    • “The decision to discontinue SRP-5051 was based on several factors, company executives told analysts on a conference call Wednesday. Safety concerns, feedback from the Food and Drug Administration and the “evolving landscape of Duchenne” with the approval of Sarepta’s gene therapy Elevidys all played a role, Chief Scientific Officer Louise Rodino-Klapac told analysts and investors.
    • “Elevidys revenue climbed to $181 million in the third quarter from $122 million in the second quarter, beating analyst estimates of about $160 million. Sarepta also pulled in $9.5 million in royalties from Roche, which sells the gene therapy outside the U.S.“
  • Per Fierce Pharma,
    • “Despite a mission to become a dominant cancer drug player, Gilead Sciences has as of late been locked in on its bread-and-butter antiviral franchise with an eye on the potential of its long-acting HIV med lenacapavir. 
    • “But with its cell therapy unit stalling and antibody-drug conjugate Trodelvy facing challenges, the company’s oncology ambitions were brought back under the spotlight during its third-quarter earnings report.
    • “Gilead’s once fast-growing cell therapy products have hit a wall as of late with relatively flat sales all year. Over the third quarter, lymphoma treatment Yescarta saw revenue dip 1% to $387 million compared to last year’s third quarter, while its Tecartus counterpart similarly remained flat with 2% growth to $98 million.
    • “Gilead attributed the Yescarta challenges to “increased in- and out-of-class competition” in the U.S., slightly offset by increased demand in relapsed or refractory large B-cell lymphoma (LBCL) in other regions. In terms of the outside competition, one notable rival includes Bristol Myers Squibb’s rival CD19 CAR-T Breyanzi.”
  • Per MedTech Dive,
    • “Johnson & Johnson received Food and Drug Administration approvalfor its Varipulse pulsed field ablation (PFA) system, joining Boston Scientific and Medtronic in the U.S. market for the fast-growing atrial fibrillation (AFib) treatment.
    • “Varipulse is approved to treat patients with drug-resistant, recurrent paroxysmal AFib, a common form of abnormal rhythm in the heart’s upper chambers, the company said Thursday. The platform is integrated with J&J’s Carto 3 mapping system in a single device that enables electrophysiologists to view inside the heart to position the catheter. 
    • “We are confident that this eagerly awaited platform will be a valuable tool for physicians in performing safe, effective and efficient AFib procedures with an intuitive and reproducible workflow,” Jasmina Brooks, president of electrophysiology at J&J Medtech, said in a statement.”

Midweek Update

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, OPM, U.S. Healthcare–
President Grover Cleveland Photo by Library of Congress on Unsplash

From Washington, DC

  • President Donald Trump was reelected following an intervening term by another President in the fashion originated in the late 1800s by President Grover Cleveland, who was a Democrat.
  • NBC News adds this afternoon,
    • “Republicans will win control of the Senate for the next two years, NBC News projects, though control of the House is still up for grabs.
    • “Senate Republicans ousted Democrats in red states to secure the majority, flipping seats in West Virginia, Montana and Ohio, states that have swung heavily to the GOP. And they held their ground in friendly states like Texas and Florida, assuring them at least 51 seats when the new Congress is sworn in next January.” * * *
    • “The GOP senators are expected to elect a new leader next week as longtime Republican leader Mitch McConnell, R-Ky., is stepping down from the role after a record 18 years. His current deputy, Sen. John Thune, R-S.D., and former deputy, Sen. John Cornyn, R-Texas, are battling to take the job when the new Congress begins.”
  • Congress’s lame duck session begins next Tuesday November 12, and it will be a busy time for the legislators. You will recall that on September 26, President Biden signed into law,
    • “H.R. 9747, the “Continuing Appropriations and Extensions Act, 2025,” which provides fiscal year 2025 appropriations to Federal agencies through December 20, 2024, for continuing projects and activities of the Federal Government.” 
  • Govexec discusses FEHB plan fertility benefit offerings for 2025.
  • WTW Consulting shares advice on how to effectively use healthcare and dependent care FSAs.
  • Per MedTech Dive,
    • “Advamed has asked for Medicare to cover supplemental imaging of patients with heterogeneously and extremely dense breast tissue.
    • “In a letter sent to the Centers for Medicare & Medicaid Services Friday, the medtech industry group said many individuals with dense breasts currently have to pay out of pocket or forgo potentially life-saving additional testing.
    • “Advamed made the request two months after the Food and Drug Administration began requiring mammographers to notify patients when they have dense breast tissue. Traditional mammography is less sensitive than other imaging technologies in dense breasts, which increases the risks of imaging to miss cancer.”

From the public health and medical research front,

  • The American Hospital Association News lets us know,
    • “The Centers for Disease Control and Prevention Nov. 6 released its annual progress report on health care-associated infections, which showed continued decreases in hospitalizations last year. There was a 16% decrease in hospital-onset methicillin-resistant Staphylococcus aureus, or MRSA; a 15% decrease in central line-associated bloodstream infections, or CLABSI; a 13% decrease in hospital-onset Clostridioides difficile (C. difficile) infection; an 11% decrease in catheter-associated urinary tract infections; and a 5% decrease in ventilator-associated events. The declines align more closely with progress made prior to the COVID-19 pandemic in 2020, the CDC said. 
    • “For inpatient rehabilitation facilities, there was a 14% decrease in hospital-onset C. difficile infection and an 8% increase in CAUTI in 2023, but no significant changes in CLABSI and hospital-onset MRSA standardized infection ratios compared with 2022. Among long-term care hospitals, there was a 13% decrease in hospital-onset C. difficile infections but no significant changes in 2023 SIRs compared with 2022. 
    • “The report recommends facilities continue reinforcing prevention practices and review HAI surveillance data to identify areas for improvement.”
  • MedPage Today tells us,
    • The FDA announced marketing authorization of a form of light therapy as the first-ever treatment for dry age-related macular degeneration (AMD).
    • LumiThera’s Valeda Light Delivery System generates light at different wavelengths to stimulate and improve the function of retinal mitochondria. The photobiomodulation (PBM) system is the first treatment shown to improve vision loss associated with dry AMD.
    • “Patients will now be able to try a non-invasive treatment that can help improve their vision earlier in the disease process,” said David Boyer, MD, of Retina Vitreous Associates Medical Group in Beverly Hills, California, in a company statement. “This is an exciting option for patients, and something doctors and patients have been waiting for.”
  • The National Cancer Institute informs us,
    • “Every year, almost 90,000 of these adolescents and young adults (AYAs)—generally defined as people between the ages of 15 and 39—receive a cancer diagnosis. And this group of patients often needs extra help navigating the complexities of cancer care.
    • “A new study has shown that a program in place for a decade at the University of North Carolina (UNC) Lineberger Comprehensive Cancer Center substantially increased its assistance to AYAs with cancer being treated at the center. For example, there were large increases in the number of AYAs who underwent fertility counseling, a particularly important consideration for this age group. The program also substantially boosted AYA enrollment in clinical trials and helped more AYAs get other care recommended by national guidelines. 
    • “The UNC team is now working to standardize many components of the program so it can be adapted by other cancer centers, explained Jacob Stein, M.D., M.P.H., who presented the findings from an evaluation of the program in September at the American Society of Clinical Oncology’s Quality Care Symposium.
    • “A lot of [centers] are now reaching out and asking: ‘How do we do this?’” said Dr. Stein. And the timing is right for the wider availability of programs to help AYAs with cancer, he added.
    • “Studies are showing that cancer is on the rise in younger adults,” he said. “That’s a concerning trend, but there are a lot of folks now engaged and talking about cancer in AYAs in a way that we weren’t 5 or 10 years ago.”
  • and
    • “[H]ow well does telehealth perform when it comes to delivering palliative care for people with cancer, which can rely on a deeper level of connection between patients and providers than may be possible with a virtual visit?
    • “A study of 1,250 people with advanced lung cancer has now provided some insights into that question. The study found that virtual and in-person palliative care were similarly effective in improving patients’ quality of life and other important measures of well-being, according to findings published September 11 in JAMA. It also found benefits for caregivers. 
    • “The results show that “we can successfully deliver … high-quality [palliative] care in person and virtually,” said Joseph A. Greer, Ph.D., of Massachusetts General Hospital, who led the study.
    • “The study results also have implications for the accessibility of palliative care, Dr. Greer noted. Telehealth provides a way for people with cancer who live in rural areas where there may not be many palliative care providers or who don’t have reliable transportation to receive palliative care. 
    • “Many of us see the potential that telehealth can have, and studies like this go a long way to help provide the evidence” needed to demonstrate that it can be used effectively as part of something as complex as palliative care, said Roxanne Jensen, Ph.D., of NCI’s Healthcare Delivery Research Program, who was not involved in the study.” 
  • Per Healio,
    • “Respiratory syncytial virus vaccines proved highly effective at preventing hospitalization and ED visits in older adults, even in those with immunocompromising conditions, results from an observational analysis showed.
    • “The findings, published in The Lancet, are consistent with previously reported data on respiratory syncytial virus (RSV) vaccine effectiveness.”
  • Per Medscape,
    • “Nilotinib, a drug approved by the US Food and Drug Administration (FDA) to treat chronic myeloid leukemia, improved biomarkers and cognitive outcomes in patients with dementia with Lewy bodies (DLB) in a phase 2 randomized, double-blind, placebo-controlled trial. 
    • “The findings align with an earlier study that showed possible disease-modifying effects of nilotinib in patients with mild cognitive impairment or Alzheimer’s disease, as previously reported by Medscape Medical News. 
    • “We’re looking at repositioning or repurposing tyrosine kinase inhibitors for neurodegenerative diseases,” said study investigator Raymond Scott Turner, MD, PhD, of Georgetown University School of Medicine in Washington, DC.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “CVS reported mixed third-quarter results shadowed by heightened medical costs on Wednesday, in the massive healthcare enterprise’s first earnings report with new CEO David Joyner at the helm.
    • “The Woonsocket, Rhode Island-based company beat Wall Street expectations on revenue of $95.4 billion, up more than 6% year over year. However, CVS’ net income fell to $71 million, down from almost $2.3 billion same time last year, as its Aetna insurance arm continued to struggle with higher spending.
    • “CVS appointed Steve Nelson, previously the CEO of value-based primary care company ChenMed, as president of Aetna. Nelson also ran UnitedHealthcare, the largest private insurer in the U.S., from 2016 to 2019.”
  • Health Affairs Scholar concludes,
    • “The No Surprises Act banned surprise billing and established a final-offer arbitration system, independent dispute resolution (IDR), to resolve disagreements between health plans and providers. One factor that arbiters must consider in the IDR process is the qualifying payment amount (QPA), the median contracted rate for the same or similar service in the same market as computed by health plans. We analyzed public IDR data from 2023 for the most common disputed professional service: evaluation and management of a moderate to severe emergency medicine visit. Providers won 86% of cases, with mean decisions 2.7 times the QPA. Private equity-backed providers won more often and higher monetary awards than other providers. The mean QPA was 2.4 times Medicare payments. Disputes were dominated by a small group of health plans and providers, so payments may not reflect the overall market for emergency services.”
  • Per Fierce Pharma,
    • “As other biopharma giants have divested their generics units to focus on the development and commercialization of innovative drugs, Teva has relied on its copycat business to help trigger its rebound under CEO Richard Francis.
    • “Wednesday, Teva revealed booming third-quarter sales for its generics and biosimilars. In the U.S., revenue from the knockoffs came in at $1.1 billion, which was a 30% increase year over year, or 7% sequentially. Sales of generics and biosimilars also were up 10% year over year in Europe.
    • “The figures contributed heavily to Teva’s overall success in the quarter. Its revenue of $4.3 billion topped analysts’ consensus of $4.14 billion and was a 13% gain year over year. With the result, Teva tweaked its annual guidance up by $100 million at both ends to a window of $16.1 billion to $16.5 billion.”
  • MedCity News notes,
    • “While employers are prioritizing mental and physical wellbeing programs, employees report that what they really want is financial wellbeing support, according to a new survey.
    • “The survey was released last week by WTW, a global advisory, broking and solutions company. It included responses from 535 employees at medium and large private sector employers.
    • “The organization found that 73% of employers prioritize mental wellbeing and 50% prioritize physical wellbeing. However, 66% of employees say that financial wellbeing is their biggest concern. For employers, only 23% of respondents listed this as a priority. This comes as just 41% of employees feel financially secure, according to the survey.”

Tuesday Tidbits

David Ermer–CDC, CMS, Medical / Rx research, Obesity, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • Reuters reports,
    • “Journey Medical (DERM.O) said on Monday the U.S. Food and Drug Administration has approved its drug for the treatment of a long-term skin condition called rosacea.
    • “Rosacea is a skin condition causing chronic inflammation of the facial skin and is often classified into four types.
    • “The oral antibiotic, branded Emrosi, was approved to treat lesions associated with inflammatory rosacea, which causes persistent redness and small pus-filled bumps on the face.”
  • Per Federal News Network,
    • “Of all the areas the Federal Employee Viewpoint Survey (FEVS) measures, federal employees’ views of senior leadership may be one of the trickier categories to unpack.
    • “The “leaders lead” category on FEVS typically results in lower scores from federal employees than the category measuring views of immediate supervisors. But the senior leadership score for this year’s survey still increased from 61% to 63% between 2023 and 2024, the Office of Personnel Management reported last month. Looking back a bit further, employees’ views of senior leadership have risen 4% since 2022.
    • “It’s certainly a positive finding in the governmentwide results of the 2024 FEVS, but looking more deeply at the survey results, there appears to be variation based on how closely situated employees are to their agency’s headquarters.
    • “In a FEVS data dashboard, OPM’s breakdown of results by each Federal Executive Board (FEB) geographic region shows that federal employees located in the “Eastern” FEB — or those closer to many agency headquarters — have higher scores than those working in the areas covered by the Western FEB, who are for the most part geographically farther from headquarters.”
  • From the public health and medical research front,
  • The American Hospital Association lets us know,
    • “Reports of cases of pertussis, also known as whooping cough, are currently five times higher compared to last year, according to the Centers for Disease Control and Prevention. The rise indicates the U.S. is returning to pre-pandemic patterns of typically 10,000-plus cases each year, and that mitigation measures such as masking and remote learning during the pandemic lowered transmission, the CDC said. The agency said that vaccination is the best way to prevent pertussis, but it expects cases to continue to increase among vaccinated and unvaccinated populations.” 
  • The Wall Street Journal adds,
    • “If you’ve had a lingering cough recently, there is a chance the culprit wasn’t Covid-19, flu or RSV, but mycoplasma pneumoniae.
    • “Levels of this milder lung infection—which can lead to “walking pneumonia”—are 10 times greater than last year, according to the Centers for Disease Control and Prevention [“CDC”]. Though the CDC doesn’t officially track the disease, it issued an alert last month noting the rise in cases. Levels of walking pneumonia, so named because patients often feel well enough to go about their normal daily activities, typically peak every three to seven years.
    • “Chris Edens, lead of the CDC team that tracks Legionella and atypical pathogens, said the agency saw a rise of cases in late spring. It peaked in August, then declined a bit. The decrease might not last, he adds, noting “levels seem to be flattening out or maybe even ticking back up.”
    • “Cases of walking pneumonia are up across all age groups, with children 17 and under experiencing the largest rise, says Edens.”
  • The CDC reminds us that November is diabetes month. The agency offered its quick pre-diabetes test.
  • BioPharma Dive tells us,
    • “A medicine built around a more precise form of CRISPR gene editing appeared to work as designed in its first clinical trial test, developer Beam Therapeutics said Tuesday. But the death of a trial participant could renew concerns about an older drug used alongside Beam’s genetic medicine.
    • “Beam’s medicine uses a technology known as base editing to activate a gene in stem cells collected from people with sickle cell disease, an inherited blood condition that can cause debilitating pain and a constellation of other symptoms.
    • “Data shared by Beam from the first handful of patients treated in the trial show the company successfully edited those cells in a laboratory. When later reinfused back into patients’ bodies, they matured into red blood cells that were more durable and less likely to warp into the sharp-edged crescents associated with the disease.
    • “However, one of the patients died from lung damage that was judged by their physician and the trial’s monitoring committee as related to an old chemotherapy drug commonly used prior to stem cell transplants. The Food and Drug Administration also reviewed the case. 
    • “Called busulfan, this drug is known to be toxic. But it is effective at creating an opening in the bone marrow for newly edited stem cells to take root, a necessary step for infusing gene editing therapies like Beam’s.
    • “Beam is working on a solution to sidestep busulfan and, on Tuesday, also released data from testing in monkeys showing how it may work.”
  • Per Medpage Today.
    • “Greater use of virtual mental health care services was linked to a lower risk of suicide-related events, according to a retrospective cohort study.
    • “The study of more than 16,000 veterans with prior mental health diagnoses showed that a 1% increase in the proportion of mental health care received through telehealth services was associated with a 2.5% decrease in suicide-related events, Kertu Tenso, PhD, of Boston University School of Public Health, and co-authors reported in JAMA Network Open.”
  • Per Healio,
    • “Ex-smokers with a light lifetime smoking burden had a CVD [cardiovascular disease] risk shortly after quitting similar to those who have never smoked, results from a cohort analysis showed.
    • “However, findings from the retrospective study suggest that ex-smokers who smoked heavily may need to restrain from smoking for more than 25 years to have a cardiovascular risk similar to those who have never smoked.”
  • MedCity News suggests “A Recipe for Better Obesity Care: Integrating GLP-1s with Food as Medicine. Nutrition isn’t a supplement — it’s foundational to metabolic health. It’s time we integrate more ‘Food as Medicine’ initiatives alongside the GLP-1 therapies that are gaining traction.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Three independent pharmacies have filed separate lawsuits accusing GoodRx, which markets a prescription drug discount card, of conspiring with several pharmacy benefit managers to fix reimbursement fees, the latest skirmish over the opaque pharmaceutical supply chain in the U.S.
    • “At issue are the behind-the-scenes transactions involving generic drugs, which account for an estimated 90% of the prescriptions written in the U.S. and, consequently, represent a lucrative market. The lawsuits claim, however, that GoodRx and some of the largest PBMs coordinate their reimbursement policies in a way that has deliberately reduced fees for the pharmacies.”
    • “The “anti-competitive” tactic has contributed to deteriorating finances for a growing number of independent pharmacies, according to the lawsuits, which noted “thousands” of local drug stores have closed in recent years. The pharmacies argued the dispute is one of several over reimbursement fees that, ultimately, favor pharmacies affiliated with the PBMs themselves.
    • “The upshot of this scheme is that the conspiring PBMs, by coordinating their reimbursement decisions through GoodRx, never pay pharmacies more for generic drugs than any rival PBM has agreed to pay in its separate negotiations with those pharmacies. This is nothing more than price fixing,” argued a lawsuit filed by Community Care Pharmacy, which is based in Michigan and sued only GoodRx.”
  • Modern Healthcare informs us,
    • “Signify Health is tapping into resources from parent company CVS Health to grow the number of in-home services it can provide.
    • “Signify conducts in-home health evaluations for patients, and if needed, connects them to primary care or other follow-up services. It works with health plans to identify members who could benefit from an evaluation. CVS acquired Signify a year-and-a-half ago in a $8 billion deal, just a couple of months before closing a $10.6 billion acquisition of primary care provider Oak Street Health.
    • “Joining CVS — which also includes the core retail pharmacy, insurer Aetna and pharmacy benefit manager Caremark — brought Signify into a larger ecosystem with opportunities to increase its care coordination offerings. In October, CVS ousted former CEO Karen Lynch, who oversaw the Signify deal and other efforts to diversify the parent company’s assets.
    • “That hasn’t affected Signify President Paymon Farazi’s plans to expand the kinds of services the company can provide as part of its in-home health evaluations. Farazi said in an interview his aspirations for Signify range from adding more diagnostic tests to moving into clinical care.”
  • MedCity News discusses five healthcare companies which attracted one of its journalist’s attention at the HLTH24 conference.
  • Per MedTech Dive,
    • “The Centers for Medicare & Medicaid Services granted transitional pass-through (TPT) payment status to Medtronic and Recor Medicalfor renal denervation devices to treat high blood pressure.
    • “The TPT program provides additional funding to hospitals to encourage use of new Food and Drug Administration-approved therapies as the CMS gathers cost data to determine future reimbursement rates under the Medicare outpatient prospective payment system. The companies announced the coverage decisions on Friday.
    • “Jason Weidman, president of Medtronic’s coronary and renal denervation business, called the payment approval for the Symplicity Spyral catheter an “important milestone” for the company’s renal denervation procedure because it will reduce cost barriers for healthcare systems. The company has pegged the market as a $1 billion-plus opportunity.”
  • Beckers Hospital Review relates,
    • “Altamonte Springs, Fla.-based AdventHealth has partnered with Walmart to open a hybrid primary care clinic inside one of its stores [located in Corbin, Kentucky]. * * * Since Walmart shuttered its own retail health clinics and virtual care service, it has been leasing space to health systems, including Chesterfield, Mo.-based Mercy.”

Friday Factoids

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

From Washington, DC,

  • Lots of CMS announcements today.
    • Calendar Year (CY) 2025 Medicare Physician Fee Schedule Final Rule (Fact Sheet)
      • “By factors specified in law, average payment rates under the PFS will be reduced by 2.93% in CY 2025, compared to the average amount these services were paid for most of CY 2024. The change to the PFS conversion factor incorporates the 0% overall update required by statute, the expiration of the temporary 2.93% increase in payment for CY 2024 required by statute, and a relatively small estimated 0.02% adjustment necessary to account for changes in work relative value units (RVUs) for some services. This amounts to an estimated CY 2025 PFS conversion factor of $32.35, a decrease of $0.94 (or 2.83%) from the current CY 2024 conversion factor of $33.29.”
    • CY 2025 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule (Fact Sheet)
      • “In accordance with Medicare law, CMS is finalizing an update to OPPS payment rates of 2.9% for hospitals that meet applicable quality reporting requirements. This update is based on the projected hospital market basket percentage increase of 3.4% reduced by a 0.5 percentage point productivity adjustment.
      • “In the CY 2019 OPPS/ASC final rule with comment period, CMS finalized a proposal to apply the hospital market basket update to ASC payment system rates for an interim period of five years (CY 2019 through CY 2023). The CY 2024 OPPS/ASC final rule with comment period extended the interim period for an additional two years (through CY 2024 and CY 2025).
      • “Accordingly, using the hospital market basket update, CMS is finalizing an update factor to the ASC payment rates for CY 2025 of 2.9%. The update applies to ASCs meeting relevant quality reporting requirements. This update is based on the projected hospital market basket percentage increase of 3.4% reduced by a 0.5 percentage point productivity adjustment.”
    • Calendar Year 2025 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Final Rule (Fact Sheet)
      • “For CY 2025, CMS is increasing the ESRD PPS base rate to $273.82, which CMS expects will increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 2.7%. The CY 2025 ESRD PPS final rule also includes changes to the methodology for calculating the ESRD facility wage index, changes to the Low-Volume Payment Adjustment (LVPA) methodology, and several changes to the ESRD outlier policy.”
  • Per an October 30, 2024, CMS press release.
    • CMS updated the ‘Birthing-Friendly’ designation icons on Care Compare for the first time since rolling out the initiative in October 2023. Hospitals that attested to the Maternal Morbidity Structural measure in the Hospital Inpatient Quality Reporting Program received the designation. The icons will be refreshed using updated data from CY 2023. CMS created the designation to identify hospitals and health systems that participate in a statewide or national perinatal quality improvement collaborative program and that implement evidence-based care to improve maternal health. Eighty percent of pregnancy-related deaths are preventable, and Black, American Indian and Alaska Native, and Native Hawaiian and Pacific Islander people have the highest rates of pregnancy-related death. The ‘Birthing- Friendly’ designation is a step towards ensuring that all pregnant and post-partum people can find high-quality maternity care. 
  • Bloomberg adds,
    • The [Medicare physician fee schedule] rule quickly elicited calls for Congress to overhaul the way Medicare sets payment rates. Federal law requires that any payment increases be offset by equal cuts elsewhere in the program.
    • “To put it bluntly, Medicare plans to pay us less while costs go up. You don’t have to be an economist to know that is an unsustainable trend, though one that has been going on for decades,” said a statement from Bruce A. Scott, president of the American Medical Association. 
    • “For physician practices operating on small margins already, this means it is harder to acquire new equipment, harder to retain staff, harder to take on new Medicare patients, and harder to keep the doors open, particularly in rural and underserved areas,” Scott said.
  • and
    • “Overall Medicare payments to home health agencies will increase by 0.5%, or $85 million, next year under a final rule released Friday.
    • “The total amount reflects a 2025 payment increase of 2.7%, or $445 million, according to the rule (RIN 0938-AV28) from the Centers for Medicare & Medicaid Services. But that amount would be offset by an estimated 1.8% payment cut of $295 million as part of a “permanent behavior adjustment” based on the assumption that home health agencies altered their billing and coding activity to maximize reimbursements in previous years.
    • “The payment offsets are part of a CMS plan to use future rulemaking to recover billions of dollars in apparent overpayments.”
  • The American Hospital Association reminds us,
    • “Beginning Nov. 1 through Jan. 15, individuals and families can enroll in or change their health coverage options through the Health Insurance Marketplace. The Centers for Medicare & Medicaid Services expects that 97% of the website’s customers will have access to three or more insurance issuers and four in five can find coverage for $10 or less per month after subsidies. AHA’s #GetCovered page offers resources to help people choose the best coverage for themselves and their families.”  
       
  • Govexec reports that “Most TSP funds took a tumble in October. Only two portfolios in the federal government’s 401(k)-style retirement savings program ended last month in the black, ending a three-month run of gains.”
  • STAT News relates,
    • “The hospital industry has pushed back against Medicare payment reforms for years, arguing that the policies would financially hurt rural hospitals. 
    • “Two key senators on Friday released a plan to get around that issue by reinvesting some of the money saved from payment reforms to help rural and safety-net hospitals. Hospitals that keep providing services like trauma centers, labor and delivery units, and burn units would get financial bonuses, too. 
    • “The reforms, called “site-neutral” payments, would equalize Medicare payments for some services provided at hospital outpatient departments with what the program pays physician offices for the same services. The hospital industry at large has opposed the policy because it argues hospitals should get paid more because they have to provide round-the-clock care and have higher overhead costs. 
    • “Sen. Maggie Hassan (D-N.H.), who has led efforts on the issue, partnered on the policy proposals with Sen. Bill Cassidy (R-La.), who’s in line to lead the Senate’s health committee if Republicans take control of the chamber next year and sits on the committee that regulates Medicare payments. Hassan’s current GOP partner on a stalled site-neutral bill, Sen. Mike Braun (R-Ind.), is leaving the Senate at the end of this year.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • COVID-19 activity is declining in most areas. Minimal seasonal influenza activity is occurring nationally. Signs of increased RSV activity have been detected in the southern and 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 most areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels. National trends in growth of COVID-19 infections are uncertain overall. Decreases are predicted in some states, and slow growth is predicted from a low level in others.
      • The XEC variant is estimated to comprise 14-22% of circulating viruses as of October 26, 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 remains low. However, continuing signs of increased RSV activity have been detected in the southern and southeastern United States, particularly in young children. Emergency department visits and hospitalization rates are increasing in young children in some areas.
    • Vaccination
  • ABC News tells us,
    • “The total number of dengue fever cases in the U.S. is now more than double the number recorded all of last year, federal data shows.
    • “More than 6,800 cases of dengue have been reported nationally so far this year, according to data from the Centers for Disease Control and Prevention (CDC). Of those cases, more than 4,400 were locally acquired and more than 2,300 are travel associated.
    • “Locally acquired cases mean that those infected have no history of traveling to an area where dengue normally spreads, including tropical and subtropical areas of the world.
    • “The 6,800 figure is more than double the 3,352 dengue cases reported during all of 2023, CDC data shows.
    • “Currently, Puerto Rico makes up the bulk of cases this year with more than 4,200 reported there, according to CDC data. Earlier this year, the territory declared a public health emergency amid a rise in dengue case.”
  • The American Journal of Managed Care lets us know,
    • “Early smoking cessation post-cancer diagnosis significantly improves survival, with optimal benefits seen when quitting within 6 months.
    • “The Tobacco Research and Treatment Program at MD Anderson offers free, evidence-based cessation interventions, including counseling and pharmacotherapies.
    • “The study highlights a reduced mortality risk for patients who quit smoking by 3-, 6-, and 9-months post-treatment.
    • ‘Limitations include potential bias from self-reported abstinence and lack of data on noncancer health conditions.”
  • The University of Minnesota’s CIDRAP informs us,
    • “A multistate study of publicly insured children diagnosed as having pneumonia found that one in five did not receive antibiotics, researchers reported yesterday in JAMA Network Open.
    • “But while children who didn’t receive antibiotics had slightly higher rates of treatment failure than those who did, severe outcomes were rare regardless of antibiotic treatment, the researchers found.
    • “The study authors say their findings suggest future research should aim to identify children with pneumonia who can be safely managed without antibiotics.” 
  • STAT News reports,
    • “Novo Nordisk’s weight loss drug Wegovy helped people with a fatty liver disease called MASH experience improvements in liver scarring and achieve symptom resolution, results the company sees as supporting regulatory approval.
    • “After 72 weeks in a Phase 3 trial, 37% of patients on Wegovy experienced an improvement in liver scarring, or fibrosis, with no worsening of their disease. That compared with 23% of those on placebo, according to topline results Novo announced Friday.
    • “Additionally, 63% of people on Wegovy achieved resolution of their symptoms with no worsening of fibrosis, compared with 34% of participants on placebo.
    • “Novo said the results were statistically significant.
    • “GLP-1 drugs like Wegovy are increasingly being tested in a range of conditions beyond obesity, including diseases that affect the heart, kidneys, and liver. Wegovy is already approved to prevent cardiovascular complications, and for Novo, proving that the drug helps with even more complications may help it gain broader and more streamlined insurance coverage.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Tenet Healthcare posted $5.1 billion in revenue for the third quarter, exceeding analysts’ expectations as the provider’s hospital and ambulatory segments fielded higher-than-expected patient volumes.
    • “Business in Tenet’s ambulatory care service line was particularly strong, executives said during a Tuesday morning call with investors. Adjusted earnings before interest, taxes, depreciation and amortization for Tenet’s ambulatory surgery centers and surgical hospitals sat nearly 19% higher than this time last year at $439 million.
    • “Still, the company lowered the upper end of its 2024 revenue guidance to $20.6 billion to $20.8 billion, compared to prior guidance of $20.6 billion to $21 billion. Analysts from Leerink Partners said the revision was likely due to the performance of Tenet’s hospital portfolio and the timing of several hospital divestitures.”
  • Beckers Hospital Review points out,
    • “The University of Alabama at Birmingham Health System Authority has acquired Ascension St. Vincent’s Health System, effective Nov. 1. 
    • “Under the agreement, UAB Health System assumed ownership of all Ascension St. Vincent’s care sites, including the hospitals at Birmingham, Blount, Chilton, East and St. Clair, as well as the Trussville Freestanding Emergency Department, imaging centers and other clinics that are part of Ascension Medical Group. 
    • “The transaction was valued at $450 million.” 
  • Kaufmann Hall offers an infographic “reassessing retail health disruptors” one year later.

Friday Factoids

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

From Washington, DC

  • NBC 10 Buffalo NY reports
    • Capital District Physicians’ Health Plan (CDPHP) will no longer be offering its plan for Federal Government employees. A spokesperson for CDPHP said this affects about 6,000 members.
    • “At the beginning of 2024, due to compounding regulations and rising administrative costs, CDPHP made the difficult decision to exit the Federal plan at the end of this plan year,” said the spokesperson. “Federal plan employees will need to select a new plan/carrier during this year’s Open Season.”
    • The FEHBlog remembers an OPM FEHB carrier conference which featured a CDPHP speaker due to the quality of the Plan’s services.
    • OPM does pile benefit and administrative costs on FEHB carriers. The straw that may have broken the camel’s back was OPM’s January 2023 mandate to cover GLP-1 drugs for obesity. That unexpected cost still reverberates in FEHB premiums today.
    • The FEHBlog is not saying that OPM should not have mandated GLP-1 drugs for obesity. The FEHBlog is saying that OPM should have put that mandate in a call letter for benefit and rate proposals so that plans could build the cost into their premiums as federal procurement law requires.
  • The OPM Inspector General weighed in again on the Postal Service Health Benefits Program implementation process.
  • The Miller and Chevalier law firm lets us know,
    • “On October 17, 2024, the Internal Revenue Service (IRS) issued Notice 2024-75 to expand preventive care benefits permitted by a high deductible health plan (HDHP) under section 223(c)(2)(C) of the Internal Revenue Code. The guidance states that over-the-counter (OTC) contraceptives and male condoms, types of breast cancer screenings beyond mammography, and certain types of diabetes care all qualify as preventive care.” * * *
    • “Notice 2024-75 is generally effective for plan years that begin on or after December 30, 2022.”
    • “In related concurrent guidance, the IRS issued Notice 2024-71, which provides a safe harbor for amounts paid for condoms by use by the taxpayer, spouse, or dependent under section 213(d) of the Code. “
  • The American Hospital Association tells us,
    • “The Centers for Medicare & Medicaid Services Oct. 25 launched a preview of health coverage options available through the Open Enrollment Period for the HealthCare.gov marketplaces, set to open on Nov. 1. The Administration also announced Deferred Action for Childhood Arrivals recipients will be eligible to enroll in a marketplace plan and may be eligible for other benefits to lower health insurance out of pocket costs. As part of this year’s open enrollment, CMS updated the HealthCare.gov webpage and made it mobile-friendly to ease the enrollment process. The ACA marketplace open enrollment runs from Nov. 1 to Jan. 15.”
  • Here is a link to the related CMS fact sheet.
  • Per JD Supra,
    • “On October 15, Maryland Attorney General Anthony G. Brown announced that his office reached a $27 million settlement with Precision Toxicology to resolve allegations that it submitted false claims to government health programs for medically unnecessary urine drug tests and provided illegal kickbacks to physicians.
    • “Precision Toxicology, headquartered in San Diego, CA, is one of the nation’s largest urine drug testing laboratories. According to the fact recitation in the settlement documents, Precision allegedly submitted false claims for drug tests to Medicare, Medicaid, TRICARE, the Federal Employees Health Benefits Program (FEHBP), and the Department of Veterans Affairs (VA) for a period of approximately 10 years. The drug test claims submitted to the programs were allegedly medically unreasonable and unnecessary. Specifically, Precision allegedly utilized nonallowable blanket orders for urine drug tests without physician authorization and offered free point-of-care drug test cups to physicians in exchange for referrals, in violation of the Anti-Kickback Statute.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is declining in most 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 most areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels. Nationally, COVID-19 infections are predicted to be growing slowly from a low level.
      • “The XEC variant is predicted to increase to 14-22% among circulating viruses as of October 26, 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,
    • Wastewater detections [of the COVID virus] remain at low levels nationally, but detections tracking a bit higher in the West and Midwest compared to other regions, according to CDC data. Similarly, WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, said its monitoring has the nation at the medium level, with a downward trend over the past 3 weeks. It said the South and West are now in the low category.
  • The Food and Drug Administration informs us,
    • “Today, the FDA updated the advisory for the outbreak of E. coli O157:H7. A specific ingredient has not yet been confirmed as the source of the outbreak, but most sick people report eating McDonald’s Quarter Pounder burgers. Investigators are working to determine if the slivered onions or beef patties on Quarter Pounder burgers are the likely source of contamination. McDonald’s has temporarily stopped using Quarter Pounder slivered onions and beef patties in affected states. Diced onions and other types of beef patties used at McDonald’s have not been implicated in this outbreak. Additionally, Taylor Farms has initiated a voluntary recall of some onions sent to food service customers. Customers who are impacted have been contacted directly. As of Oct. 24, 75 people infected with the outbreak strain of E. coli O157:H7 have been reported from 13 states. Illnesses started on dates ranging from Sept. 27, 2024, to Oct. 10, 2024. Of 61 people with information available, 22 have been hospitalized and two people developed hemolytic uremic syndrome, a serious condition that can cause kidney failure. One death has been reported from an older adult in Colorado. Of the 42 people interviewed, all 42 (100%) report eating at McDonald’s and 39 people report eating a beef hamburger. Consumers who have already eaten at McDonald’s and have symptoms of E. coli infection should contact their health care provider to report their symptoms and receive care immediately. The FDA is working closely with the U.S. Department of Agriculture, the Food Safety and Inspection Service, the Centers for Disease Control and Prevention and state partners to determine if the slivered onions or beef patties on Quarter Pounder burgers are the likely source of contamination. Additional information will be published in the advisory as it becomes available.” 
  • The American Medical Association offers “top health tips that pediatricians want parents to know.”
  • Per Fierce Pharma,
    • “Despite recent concerns from the FDA about potential off-label use and antimicrobial resistance, Dublin-based Iterum Therapeutics has scored a green light for its oral antibiotic sulopenem.
    • “Sulopenem, which will now go by the commercial moniker Orlynvah, was approved by the FDA Friday to treat uncomplicated urinary tract infections (uUTIs) caused by E. coli, Klebsiella pneumoniae or Proteus mirabilis in adult women who have limited or no alternative antibacterial treatment options.
    • “The FDA nod—Iterum’s first—marks the second approval this year for a uUTI medicine after two decades of stagnation in the field. It also represents the first U.S. approval for an oral penem—a class of antibiotics.
    • “Back in April, the FDA approved Utility Therapeutics’ Pivya (pivmecillinam). The penicillin antibiotic underpinning Utility’s drug had never before been cleared in the U.S., despite being approved in Europe for more than 40 years.”
  • Medscape tells us,
    • “The incidence of atrial fibrillation (AF) is on the rise, and recent joint guidelines from the American College of Cardiology and American Heart Association (ACC/AHA) stress the role of primary care clinicians in prevention and management.
    • “One in three White and one in five Black Americans will develop AF in their lifetime, and the projected number of individuals diagnosed with AF in the United States is expected to double by 2050.
    • “Cardiologists who spoke to Medscape Medical News said primary care clinicians can help control AF by focusing on diabetes and hypertension, along with lifestyle factors such as diet, exercise, and alcohol intake.
    • “It’s not just a rhythm abnormality, but a complex disease that needs to be addressed in a multidisciplinary, holistic way,” said Jose Joglar, MD, a professor in the Department of Internal Medicine at the UT Southwestern Medical Center in Dallas and lead author of the guidelines.
    • Joglar said primary care clinicians can play an important role in counseling on lifestyle changes for patients with the most common etiologies such as poorly controlled hypertension, diabetes, and obesity.”
  • STAT News lets us know,
    • “For people with obesity, surgeries that shrink, reshape, or otherwise alter the anatomy of the stomach have long reigned supreme as the surest way to weight loss. But in the last few years, with the approval of GLP-1 drugs like Wegovy and Zepbound, more and more people are opting for obesity medicines over gold-standard surgical treatments. 
    • “On a population level, among a subset of commercially insured individuals, that is the tradeoff that is happening” said Thomas Tsai, the lead author of a new study that looked at health records of 17 million privately insured Americans with obesity. It found that between 2022 and 2023, as prescriptions for GLP-1 drugs more than doubled, rates of bariatric surgery fell by 25.6%.
    • “The findings, published Wednesday in JAMA Network Open, mark a sharp turnaround from trends over the last decade, and spell an uncertain future for hospitals and clinics that derive a significant portion of their revenues from such procedures.”

From the U.S. healthcare business front

  • Beckers Payer Issues relates,
    • “Centene reported $713 million in net income in the third quarter, per its earnings report published Oct. 25.
    • “Total revenues in the third quarter were $42 billion, up 10.5% year over year.
    • “Total net earnings in the third quarter were $713 million, up 52% since the same period last year.
    • “The company reaffirmed its year-end adjusted EPS guidance of greater than $6.80.
    • ‘The company’s medical loss ratio was 89.2% in the third quarter and 87% during the same period last year.”
  • Per Healthcare Dive,
    • “Medicaid payment rates have yet to catch up with rising costs in the safety-net insurance program. However, conservative planning — along with business growth — yielded a surprisingly positive third quarter for health insurer Molina, according to analysts.
    • “Molina beat Wall Street expectations for earnings and revenue with a topline of $10.3 billion in the quarter, up 21% year over year, thanks in part to higher premiums. Profit of $326 million was up 33% year over year.
    • “Molina appears to be “beating the odds again” in Medicaid, Jefferies analyst David Windley said in a note on the payer’s results.”
  • Beckers Hospital Review points out that “Nashville, Tenn.-based HCA Healthcare posted an operating income of $1.9 billion (10.9% operating margin) in the third quarter of 2024, up from an operating income of $1.6 billion (10.1% margin) over the same period last year, according to its Oct. 25 financial report.”
  • Per MedTech Dive,
    • “Baxter plans to restart its highest throughput manufacturing line for IV solutions within the next week, “barring any unanticipated developments,” the company said on Thursday.
    • “Baxter is working to restore production at a North Carolina plant that makes about 60% of the U.S. supply of IV fluids, and is an important supplier of peritoneal dialysis solutions, according to the American Hospital Association.
    • “The company still has not shared a timeline for restoring full production at the facility after it was flooded by Hurricane Helene in early October. Baxter’s goal is to begin resuming production in phases by the end of the year.”
  • The Washington Post offers an interview with JC Scott, president and CEO of the Pharmaceutical Care Management Association (PCMA), the PBM trade association.
  • Beckers Payers Issues shares executive opinions on “opportunities payers can seize next year.”
  • Per Healthcare Dive,
    • “Cost management company MultiPlan is facing yet another lawsuit for allegedly conspiring to underpay providers — this time, from the largest physician association in the United States.
    • “The American Medical Association’s complaint, filed Thursday in an Illinois district court, accuses MultiPlan of colluding with major health insurers to set artificially low reimbursement rates for out-of-network care, forcing providers to accept payments that often don’t cover their operating costs.
    • “The litigation, which asks the judge for an injunction requiring MultiPlan to halt the illegal practices, is the latest in a long string of suits against the company. Congress is also scrutinizing MultiPlan, which denies the allegations.”

Midweek Update

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

From Washington, DC

  • On Wednesday morning, OPM’s supplemental Postal Service Health Benefits Program final rule was posted on the Federal Register’s Public Inspection List. The Federal Register version of the rule is being published on Thursday October 24, a week or so earlier than expected.
  • The final rule maintains OPM’s proposed exclusion of Part D eligible Postal annuitants from their PSHB plan’s prescription drug benefits in the event that they opt out of their Plan’s Part D EGWP benefits. A Part D EGWP integrates the Plan’s benefits with Medicare Part D benefits.
  • A Part D EGWP member subjected to the Part D EGWP penalty continues to pay the full employee / annuitant premium for FEHB coverage.
  • On the brighter side, the final rule does prohibit PSHB plans from auto enrolling Part D eligible annuitants who live overseas because they cannot receive Medicare Part D coverage. OPM also created an opportunity for Postal annuitants to reverse course and join the Part D EGWP if they realize that opting out was a mistake. See 89 Fed. Reg. 85012, 85022.
  • MedPage Today reports,
    • “The CDC’s Advisory Committee on Immunization Practices (ACIP) on Wednesday endorsed additional doses of COVID vaccine for high-risk groups and recommended lowering the age for adult pneumococcal vaccination from 65 to 50 years.
    • “In an update to recommendations from June in three unanimous votes, ACIP recommended a second dose of the 2024-2025 COVID vaccine for adults ages 65 and older, as well as people ages 6 months to 64 years who are moderately or severely immunocompromised, and additional (three or more) doses for people ages 6 months and older who are moderately or severely immunocompromised under shared clinical decision making.
    • “The advisors also voted 14-1 to recommend a pneumococcal conjugate vaccine (PCV) for all PCV-naive adults ages 50 and older.
    • “Shortly after the ACIP meeting, CDC Director Mandy Cohen, MD, MPH, endorsed the new COVID vaccine and pneumococcal vaccine recommendations.”
  • BioPharma Dive adds,
    • “The Food and Drug Administration on Tuesday expanded the approval of Pfizer’s RSV vaccine Abrysvo to include adults aged 18 to 59 years who are at an increased risk of disease from respiratory syncytial virus.
    • “The vaccine was previously cleared in adults aged 60 years and older, as well as in pregnant women who are between 32- and 36-weeks’ gestation. With the latest expansion granted by the FDA, Pfizer claims its vaccine now holds the “broadest” indication for adults.
    • “In June, the Centers for Disease Control and Prevention tightened its guidance for RSV vaccination in older adults and delayed making recommendations for adults younger than 60. Advisers to the CDC are set to discuss RSV vaccine data this week but aren’t scheduled to vote on guidance for younger adults.”
  • Healthcare Dive lets us know,
    • “Centene is suing the federal government over its 2025 Medicare Advantage star ratings, the latest in a string of lawsuits from health insurers looking to protect their scores — and the valuable revenue they represent.
    • “The lawsuit filed Tuesday in a Missouri district court accuses the HHS of mishandling a “secret shopper” call meant to assess the quality of Centene’s customer call center, and unfairly including that call in the insurer’s ratings.
    • “Several of Centene’s plans received lower scores as a result, which could cost the insurer $73 million in revenue and cause enrollees to leave the plans — “staggering consequences” from a single call, according to the suit. Centene is requesting the judge order the CMS to recalculate its ratings without including the disputed call.”

From the public health front,

  • NBC News’ Today Show offers updated details on the McDonald’s E. coli outbreak.
  • NBC News reports,
    • Not having — or losing — your sense of smell may be linked to changes in breathing that could lead to depression, social isolation or other mental and physical health problems, a new study suggests. It’s more evidence of how important this often neglected olfactory sense is. 
    • A new analysis of breathing data from 52 volunteers over a 24-hour period revealed that people with a normal sense of smell had little spikes, or “sniffs,” during each breath that were not seen in those with no sense of smell, according to the report published in Nature Communications on Tuesday.” * * *
    • “The main takeaway from the study is better insight into some of the mental issues that some Covid patients who have lost their sense of smell experience, said the study’s lead author, Lior Gorodisky, a Ph.D. candidate in the brain sciences department at the Weizmann Institute of Science in Rehovot, Israel.” * * *   
    • “The little inhalations during a breath, known as the “sniff response,” are something that most of us experience unconsciously every day, Gorodisky said. Those little sniffs tell our brains about good and bad smells. “When you go to a bakery or a flower field, once your brain has sensed the good smell of a pastry or a flower, you immediately take a deeper breath,” Gorodisky said.”
        
  • The National Cancer Institute’s latest Cancer Information Highlights concern “Easing Money Troubles | Cachexia | Nutrition.”
  • Per an NIH press release,
    • “The National Institutes of Health (NIH) has launched a proof-of-concept precision medicine clinical trial to test new treatment combinations targeting specific genetic changes in the cancer cells of people with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The trial, funded by NIH’s National Cancer Institute (NCI), aims to accelerate the discovery of more tailored treatments for these aggressive cancers of the blood and bone marrow.
    • “NCI is uniquely positioned to conduct this type of study, which is one of a series of NCI precision medicine trials that are helping pave the way for more personalized treatment of cancer,” said W. Kimryn Rathmell, M.D., Ph.D., director of NCI. “By making these trials available to patients in communities around the country, we bring cutting edge science to people where they live and ensure that what we learn from our study participants can benefit patients like them in the future.”  * * *
    • “Learn more about myeloMATCH and the sub-studies that are currently open.”

From the U.S. healthcare business front,

  • Beckers Hospital Review identifies Healthgrades’ 50 top hospitals for surgical care, by state. 
  • Fierce Healthcare tells us,
    • “Sanford Health and Marshfield Clinic Health System have signed a merger agreement, the health systems announced on Wednesday, after first revealing their intent to combine in July.
    • “The systems said the combining would enable them to significantly improve the quality of care available to people living in the rural Midwest. Should the merger complete, the combined health system’s revenue would be about $10 billion.
    • “Sanford is the largest rural health system in the United States, including 45 hospitals, 211 clinics and more than 160 senior living centers. The Sioux Falls, South Dakota-based provider employs 2,900 physicians and advanced practice providers.
    • “Marshfield, meanwhile, has 60 clinics, 11 hospitals and a children’s hospital. It employs more than 1,700 providers, according to the announcement.
    • “Each also operates a health plan, and combined membership would top 425,000, the health systems said. * * *
    • “The deal is expected to close by the end of the year.”
  • Healthcare Dive informs us about “Executives from Amazon, Walgreens, Blue Shield of California and PhRMA [who] weighed in on how to fix the much-scrutinized pharmacy benefit manager model during HLTH 2024.”

Tuesday’s Tidbits

David Ermer–ACA, AHRQ, CDC, Congress, FDA, HSA, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • OMB’s Office of Information and Regulatory Affairs disclosed it has completed its work on OPM’s supplemental Postal Service Health Benefits rule. That rule now should appear in the Federal Register’s public inspection list shortly. The rule by the way is not on today’s list.
  • The International Foundation of Employee Benefit Plans tells us,
    • The Internal Revenue Service (IRS) released annual inflation adjustments for more than 60 tax provisions in Revenue Procedure 2024-40. Many of these adjustments affect employee benefits.
    • For example,
      • Health flexible spending cafeteria plans. For the taxable years beginning in 2025, the dollar limitation for employee salary reductions for contributions to health flexible spending arrangements rises to $3,300, increasing from $3,200 in tax year 2024. For cafeteria plans that permit the carryover of unused amounts, the maximum carryover amount rises to $660, increasing from $640 in tax year 2024.
      • HSA/HDHP changes were announced before the call letter responses were due at the end of May 2024.
  • The Wall Street Journal adds,
    • “The brackets that determine how much Americans pay in taxes each year are moving up by their smallest amount in a few years.
    • “It will take more income to reach each higher tax bracket after the roughly 2.8% inflation adjustment for 2025, the Internal Revenue Service said Tuesday. The annual adjustments are based on formulas tied to inflation.
    • “This year’s adjustments slightly outpace the current inflation rate, which has been cooling. Still, average hourly earnings rose 4% from a year earlier in September, the Labor Department said.”
  • Per an HHS press release,
    • “Today, the Department of Health and Human Services (HHS), through the Office of Assistant Secretary for Planning and Evaluation (ASPE), released new data showing that nearly 1.5 million people with Medicare Part D saved nearly $1 billion in out-of-pocket prescription drugs costs in the first half of 2024 because of the Biden-Harris Administration’s Inflation Reduction Act. Thanks to the Inflation Reduction Act, some people with high drug costs have their out-of-pocket drug costs capped at around $3,500 in 2024. Next year that cap lowers to $2,000 for everyone with Medicare Part D. The report shows that if the $2,000 cap had been in effect this year, 4.6 million enrollees would have hit the cap by June 30 and would not have to pay any more out-of-pocket costs for the rest of the year.”
    • “To view the full ASPE issue brief, “Medicare Part D Enrollees Reaching the Out-of-Pocket Limit by June 2024” visit: https://aspe.hhs.gov/reports/medicare-part-d-oop-cap“
  • KFF offers a data note.
    • “Overall, just under half of individuals with job-based health coverage are enrolled as a dependent on a family member’s plan (47%). The likelihood of enrolling as a dependent decreases with age. Nearly all children (ages 0-17) with employer-sponsored coverage are enrolled as dependents, usually on a parent’s plan. Young adults, particularly those ages 18-25, are more likely to be covered as dependents than adults overall (72% vs. 32%).
    • “The Affordable Care Act (ACA) requires most employer plans allow young adults to remain on a parent’s plan until age 26. Before the ACA, employers typically limited dependent eligibility for young adults to an age less than 26 and often imposed additional eligibility requirements. This provision of the ACA maintains considerable popularity and has been credited with reducing the uninsured rate among young adults. In 2024, 56% or 19.3 million young adults aged 18-25 were covered on an employer-sponsored plan (Figure 1).
    • “As young adults age, a greater share of those with employer coverage transitions from dependent coverage to being policyholders. For instance, while a majority of 18 and 19-year-olds with employer-sponsored coverage are still covered as dependents, the proportion decreases among those aged 24 and 25 (93% vs. 50%) (Figure 2).”
  • Seeking Alpha lets us know,
    • “Sen. Dick Durbin (D-Ill.), chairman of the Senate Judiciary Committee, has sent letters to Pfizer and Eli Lilly regarding the two drug giants’ relationships with telehealth platforms.
    • “Durbin is seeking to find out whether the two pharmaceutical companies are violating federal anti-kickback laws, according to the letters.
    • “Both Pfizer and Lilly this year launched websites for consumers to find out about their medications, as well as links to talk to a physician online that can prescribe them and an online pharmacy to get prescriptions filled. Pfizer’s is called PfizerForAll, while Lilly’s is name LillyDirect.
    • “Durbin, along with Sens. Bernie Sanders (I-Vt.), Elizabeth Warren (D-Mass.), and Peter Welch (D-Vt.), argue that these setups are designed to push consumers to particular drugs “and create the potential for inappropriate prescribing that can increase spending for federal health programs.”
    • “Regarding Pfizer’s platform, the senators say the ease of getting meds prescribed “creates the impression that any patient interested in a particular medication can indeed receive it with just a few clicks, and the appearance of Pfizer’s approval that these chosen telehealth providers can ensure a patient receives the given medication.”
  • It strikes the FEHBlog as strange that these legislators are attacking the drug manufacturers for disintermediating the middlemen.
  • Fierce Pharma reports
    • “With Johnson & Johnson sweetening the pot and mustering up the support of 83% of those who claim that the company’s talc products caused their cancer, it had appeared that the sides were speeding toward a resolution of the litigation through J&J’s third bankruptcy attempt.
    • “But the U.S. Department of Justice (DOJ) has called a foul.
    • “In federal bankruptcy court in Houston, Texas, the U.S. Trustee program—the DoJ’s unit that oversees bankruptcy cases—has filed a motion (PDF) to dismiss a Johnson & Johnson subsidiary’s Chapter 11 bid to settle the 60,000-plus talc lawsuits.”
  • MedTech Dive lets us know,
    • “The Food and Drug Administration on Tuesday named Michelle Tarver as the permanent director of the agency’s device center, first reported by Stat and confirmed by MedTech Dive.
    • “Tarver was appointed as acting director of the Center for Devices and Radiological Health in July, when longtime leader Jeff Shuren stepped down. 
    • “FDA Commissioner Robert Califf emphasized Tarver’s “passion about data, science, medicine, and the evidence” and work to build collaboration and transparency at the agency, in an email to staff announcing the new director’s appointment viewed by MedTech Dive.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “Four workers at a commercial egg farm in Washington tested presumptively positive for H5N1 bird flu, the Washington State Department of Health announced Oct. 20. These are the first presumed human cases in the state. The individuals experienced mild symptoms and Benton-Franklin Health District officials have forwarded test samples to the Centers for Disease Control and Prevention for final confirmation and analysis. Washington is the sixth state with human H5N1 infection, which has caused outbreaks in poultry, dairy cattle and wildlife. The CDC considers the risk of H5N1 bird flu to the general public to be low.”
  • The New York Times tells us,
    • “New guidelines for preventing strokes spell out for the first time the risks faced by women, noting that pre-term births and conditions like endometriosis and early menopause can raise the risk.
    • “Prior guidelines tended to be sex-agnostic,” said Dr. Brian Snelling, director of the stroke program at Baptist Health South Florida’s Marcus Neuroscience Institute, who was not involved in writing the guidelines.
    • “Now we have more data about sex-specific subgroups, so you’re able to more appropriately screen those patients.”
    • “The focus of the recommendations by the American Stroke Association, published on Monday in the journal Stroke, is primary prevention — the effort to prevent strokes in individuals who have never had one. It represents the first such update in a decade, and it’s the playbook by which millions of Americans will be cared for.”
  • BioPharma Dive reports about “RNA editing: emerging from CRISPR’s shadow. Early study data from Wave Life Sciences suggests how editing RNA may yield viable medicines. Large and small drugmakers say such results are just the start.”
    • “RNA editing is a fast growing corner of the biotechnology sector. About a dozen companies, from privately held startups to established biotech firms, are pursuing the technology. One already has early, but promising, clinical trial results. Others could follow soon. And large pharmaceutical companies, such as Eli Lilly, Roche and Novo Nordisk, have taken an interest.
    • “RNA editing’s proponents say it may be safer and more flexible than DNA editing. Those advantages, they contend, will enable RNA editing to address more diseases, including common conditions that are now beyond genetic medicine’s reach.
    • “It has all the features of a technology that could leapfrog other editing technologies,” said Michael Ehlers, a general partner at Apple Tree Partners and the CEO of RNA editing startup Ascidian Therapeutics.”
  • The U.S. Preventive Services Task Force has opened for public comment its Grade B recommendation that doctors “provide or refer pregnant and postpartum persons to interventions that support breastfeeding.” This is a confirmation of a 2016 Grade B recommendation. The public comment period is open until November 18, 2024.
  • Per Food Navigator
  • The Centers for Disease Control and Prevention issued the following alert today.
    • CDC, FDA, USDA FSIS, and public health officials in multiple states are investigating an outbreak of E. coli O157:H7 infections. Most people in this outbreak are reporting eating the Quarter Pounder hamburger at McDonald’s before becoming sick. It is not yet known which specific food ingredient is contaminated.
    • McDonald’s is collaborating with investigation partners to determine what food ingredient in Quarter Pounders is making people sick [mostly in Colorado and Nebraska]. McDonald’s stopped using fresh slivered onions and quarter pound beef patties in several states while the investigation is ongoing to identify the ingredient causing illness.
  • The Washington Post reports,
    • TreeHouse Foods has expanded an earlier recall of frozen waffles to include all its griddle products, including Belgian waffles and pancakes, over possible listeria contamination.
    • Though no illnesses have been reported, TreeHouse Foods has previously said that the breakfast products were widely distributed throughout the United States and Canada, primarily as private-label offerings by Walmart, Target, Tops, Harris Teeter, Publix and other large merchants.
    • The suspected contamination was discovered through routine testing at a manufacturing facility in Ontario, according to the company announcement.
    • “We are working with our retail customers to retrieve and destroy the recalled products, and encourage consumers to check their freezers for any of the products subject to the recall and dispose of them, or return them to the place of purchase for a refund,” the company said in an unsigned email.

From the U.S. healthcare business front,

  • OptumRx discusses its efforts to “automate prior authorization process for prescription drugs to improve the patient and provider experience.”
  • MedTech Dive brings us up to date on what happened at the MedTech Conference held last week in Canada.

Monday Roundup

David Ermer–ACA, CDC, FDA, Medical / Rx research, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • Today, the Affordable Care Act (ACA) regulators issued ACA FAQ 68 and a related HHS fact sheet. This letter addresses ongoing preventive care coverage issues separate from the proposed ACA rule, also issued today along with an HHS fact sheet, to expand contraceptive coverage with no cost sharing to include the OTC contraceptive pill and more.  The proposed rule will be open for public comment for sixty days after publication in the Federal Register. Government actions like the proposed rule, in the FEHBlog’s opinion, are a principal cause of skyrocketing medical costs.
  • Govexec reports,
    • “More than 200,000 U.S. Postal Service employees will receive a nearly 5% pay raise over the next year if its largest letter carriers’ union agrees to the new contract its leaders have negotiated with agency management. 
    • “The employees will also have more opportunities for overtime and be able to reach the top slots of their pay scales more quickly, the National Association of Letter Carriers said of their new tentative agreement. The contract must still be approved by NALC members before it goes into effect. A failure to ratify the deal would likely result in arbitration. 
    • “The agreement would cover the period from May 2023 into November 2026, meaning the first two of the three scheduled 1.3% wage increases would apply retroactively. Employees would also receive a series of cost-of-living adjustments, the first three would also be paid retroactively and total around $2,300. 
    • “After almost 20 months of tireless negotiations, we are pleased to reach a fair agreement that rewards our members for their contributions to the Postal Service and their service to the American people,” NALC President Brian Renfroe said.” 
  • MedTech Dive informs us,
    • “Boston Scientific received Food and Drug Administration approval for Farawave Nav, a treatment for paroxysmal atrial fibrillation (AFib) that enables cardiac mapping and pulsed field ablation (PFA) therapy with a single integrated catheter.
    • “In tandem, the company gained 510(k) clearance for new software, called Faraview, to provide visualization for cardiac ablation procedures with its Farapulse PFA system, the medical device maker said Friday. Boston Scientific will immediately launch the Farawave Nav ablation catheter and Faraview software in the U.S. 
    • “In a race among medtech companies in the PFA space, Boston Scientific is now the first with mapping-integrated PFA, “a meaningful technology step-forward,” Stifel analyst Rick Wise said Sunday in a note to clients.”
  • and
    • “The Food and Drug Administration updated the recall notice for a Boston Scientific product that blocks blood flow.
    • “Boston Scientific recalled the product, Obsidio Conformable Embolic, in February in response to a problem then linked to seven injuries and two deaths. On Friday, the FDA updated its Class I recall notice, reporting an additional two deaths and eight injuries.
    • “The FDA provided the new information after Boston Scientific on Oct. 11 updated its instructions for use for the device, which stayed on the market after the recall. While the prior alert warned of risks for lower gastrointestinal (GI) bleeding, the revised instructions reflect evidence of risks when the product is used anywhere in the GI area.”

From the public health and medical research front,

  • Health Day tells us,
    • “Walking pneumonia cases are surging among young children in the United States, federal health officials warn.
    • “Bacterial infections caused by Mycoplasma pneumoniae increased in the United States since late spring and have remained high,” a statement issued Friday by the U.S. Centers for Disease Control and Prevention noted. “The proportion of patients discharged from emergency departments with a diagnosis of M. pneumoniae-associated pneumonia or acute bronchitis has been increasing over the past six months, peaking in late August.”
    • “The worst rates of the illness have been seen in young children ages 2 to 4, according to the agency.
    • “The increase in children ages 2–4 years is notable because M. pneumoniae historically hasn’t been recognized as a leading cause of pneumonia in this age group,” the CDC added.”
  • NBC News informs us,
    • “Since 2000, breast cancer incidence among Asian American and Pacific Islander women under 50 years old has increased by 50%, more than 2% every year since 2012, according to a new report from the American Cancer Society.
    • “Asian American and Pacific Islander women in this age cohort had the second-lowest rate of breast cancer among all racial groups in 2000. They now have the highest rate alongside white women, about 86 per 100,000.
    • “Breast cancer is still more common the older we get, but it’s alarming to see younger women being diagnosed,” said Dr. Helen Chew, director of the clinical breast cancer program at UC Davis Health.
    • “Breast cancer has risen sharply among younger Asian American women in the past quarter-century due in part to acculturation and greater awareness around screenings, though experts say more research is required to determine exact causes for specific ethnic groups.
    • “Asian women like Huang have a higher prevalence of dense breasts, meaning there are more glands and tissue than fat, than women of other races, likely due to genetic factors and lower body mass indexes, experts say. And women with dense breasts are four times as likely to develop breast cancer as those with fatty breasts, an issue experts say needs more awareness.”
  • MedPage Today points out,
    • “The American Heart Association and the American Stroke Association updated guidelines for the primary prevention of stroke, emphasizing primary care screening, lifestyle management, and risk factor control.
    • “The guideline, published in Stroke, replaced the 2014 version to guide management for individuals with no prior history of stroke.
    • “This guideline is important because new discoveries have been made since the last update 10 years ago. Understanding which people are at increased risk of a first stroke and providing support to preserve heart and brain health can help prevent a first stroke,” said writing group chair Cheryl Bushnell, MD, MHS, of Wake Forest University School of Medicine in Winston-Salem, North Carolina, in a press release.
  • The Wall Street Journal relates,
    • “Novo Nordisk’s once-daily pill to treat type 2 diabetes has shown it cuts the risk of heart attacks and strokes in patients by up to 14%, according to a new trial.
    • “Rybelsus is an oral form of semaglutide, the active ingredient in the company’s blockbuster Ozempic and Wegovy diabetes and weight-loss drugs, and was tested in the trial on diabetic patients who also suffered from established cardiovascular disease and/or chronic kidney disease.
    • “Approximately one in three adults with type 2 diabetes also have cardiovascular disease; therefore, it is crucial to have therapies that can address both conditions,” said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk.
    • “The company said the drug appeared to have a safe and well-tolerated profile in line with previous oral semaglutide trials and showed it reduces the risk of major cardiovascular events such as cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.
    • “Novo Nordisk expects to file for regulatory approval of a label expansion for Rybelsus in both the U.S. and European Union around the turn of the year.”
  • The American Medical Association lets us know what doctors wish their patients knew about childhood obesity.
  • Consumer Reports discusses urinary tract infections that afflict older folks.
  • The Institute for Clinical and Economic Review published a Final Evidence Report on Treatments for Transthyretin Amyloid Cardiomyopathy.
    • An independent appraisal committee voted that current evidence is adequate to demonstrate superior net health benefits for tafamidis, acoramidis, and vutrisiran when compared to no disease-specific therapy; tafamidis and acoramidis would achieve common thresholds for cost-effectiveness if priced between $13,600 to $39,000 per year.

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Technology giant Amazon is partnering with a high-profile provider to expand its primary care offerings.
    • “Amazon One Medical will collaborate with Cleveland Clinic to open a primary care office in 2025, with plans for additional locations over the next few years, the organizations said Monday.
    • “We’re starting small with a couple of locations, … then we’ll see where it takes us,” said. Dr. Tomislav Mihaljevic, CEO and president at Cleveland Clinic. “We’re continuously evaluating potential partnerships, and this is the one that just rose to the top of what we think is the right thing for our patients.”
    • “Facilities will be staffed by One Medical clinicians. Although walk-in care will be publicly available, only One Medical members will be able to make appointments online or access telehealth, among other services.
    • “The affiliation will enable One Medical members to access specialty care at Cleveland Clinic via patient referrals, the organizations said.”
  • Per MedTech Dive,
    • “Intuitive Surgical is on track to take the da Vinci 5 robot from a limited rollout to a broader launch in mid-2025.
    • “Intuitive placed 110 da Vinci 5 systems in the third quarter, up from 70 in the second quarter, bringing the total installed base to 188, executives said on an earnings call Thursday. Customers so far have completed more than 12,000 procedures with the new platform over about the past six months, they added.
    • “Da Vinci 5 installations are “well ahead of lofty buy-side expectations,” said BTIG analyst Ryan Zimmerman. “Limited launch or not, that’s a lot of [da Vinci 5] demand,” the analyst wrote in a note to clients after the call. BTIG estimated the number of cases completed with da Vinci 5 equals nearly 32 procedures per system per quarter.”

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.”

Monday Roundup

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, Medicare, Obesity, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • BioPharma Dive lets us know,
    • “The Food and Drug Administration has temporarily deflected a lawsuit alleging it violated federal law by removing Eli Lilly’s obesity and diabetes drugs Zepbound and Mounjaro from an agency shortage list. But in the process, the regulator agreed to evaluate objections from the companies selling compounded copycats of Lilly’s fast-selling medicines.
    • “A ruling issued Friday in the U.S. District Court for the Northern District of Texas permits the makers of compounded versions of tirzepatide, the active ingredient in Zepbound and Mounjaro, to temporarily keep selling their medicines. In the meantime, the FDA and a group of compounders, led by a trade group called the Outsourcing Facilities Association, will continue negotiations. They will file a status report on Nov. 21, according to court documents.
    • “The decision is the latest twist in a saga over the supply of so-called GLP-1 medicines like Zepbound, Mounjaro and Novo Nordisk’s Wegovy, which can help people quickly lose weight. Demand for the medicines has been so strong it’s outstripped supply, leading to manufacturing shortages that have made it possible for direct-to-consumer companies to step in and offer compounded alternatives.”
  • The National Academies of Science tells us,
    • “Most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences, the 2015 National Academies report Improving Diagnosis in Health Care found. Diagnostic errors are a contributing factor in approximately 10 percent of patient deaths.
    • “A recent workshop hosted by the National Academies explored some of the potential benefits and risks involved in using artificial intelligence and other digital tools to improve medical diagnoses.
    • “Daniel Yang, vice president of AI and emerging technologies at Kaiser Permanente and chair of the workshop planning committee, noted that his current role and his prior work in philanthropy have given him a front-row seat to witness “both the incredible opportunity and the perils of applying new technology to diagnosis.”
  • Kevin Moss writing in Federal News Network advises federal and postal employees and annuitants to “Choose wisely: Not all healthcare premiums are increasing.” Mr. Moss notes “Health plan premiums will rise by an average of 13.5% next year, marking the largest increase in recent memory.” The 13.5% increase is overstated because it assumes no enrollment changes occur in Open Season.
    • For 2025, 20% of the enrollment is moving to the PSHB Program which has somewhat lower premiums. It also should be understood that FEHB premiums have been increasing because OPM required FEHB carriers to cover GLP-1 drugs for obesity in January 2023 without any advance notice. At that point, FEHB plans could not raise their premiums for almost 12 months.
    • This expensive decision came on top of healthcare cost inflation which has afflicted the economy since 2022. While OPM did allow carriers to offer Part D EGWPs for 2024, relatively large cadres opted out which lowered the new savings. Fortunately, the number of opt outs should decrease for 2025 due to the attractive, expanded Part D 2025 benefit package.
  • Bloomberg reports,
    • “Blue Cross Blue Shield agreed Monday to pay $2.8 billion to resolve antitrust claims alleging hospitals, physician groups, and other healthcare providers were shortchanged on reimbursements.
    • “The payment is the largest in a healthcare antitrust case, the healthcare providers say in their motion for preliminary approval. In addition to the funds, the settlement provides for reforms to Blue Cross’s BlueCard program, which is the company’s system of electronic claims processing for providers throughout the US and abroad. * * *
    • “Blue Cross said in a statement Monday that “we deny the allegations made in the lawsuit. However, to reach a settlement and put years of litigation behind us, we have agreed to make some operational changes and a monetary payment to the provider class involved in the case.”
    • “The case is In Re Blue Cross Blue Shield Antitrust Litigation , N.D. Ala., No. 2:13-cv-20000, motion for preliminary approval 10/14/24.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Children and teenagers infected with the coronavirus are significantly more likely to develop Type 2 diabetes than their peers afflicted with other respiratory illnesses, according to research published Monday.
    • “As the public heads into another viral season, health experts said the findings highlight how the virus continues to reveal new ways to pose detrimental long-term consequences.
    • “Children were 50 percent more likely to be diagnosed with diabetes at the six-month mark if they had endured a coronavirus infection compared with children who had another respiratory infection, according to findings published in JAMA Network Open.
    • “The subset of patients in the study who were obese were 100 percent more likely to have a Type 2 diabetes diagnosis compared with their peers beset with other respiratory infections.”
  • STAT News informs us,
    • “When the U.S. health care system pivoted to meet Covid-19 in 2020, routine health visits and screenings where many cancer cases would have been caught didn’t happen. It wasn’t ideal, but many health experts thought that as the country opened back up, screenings would help “catch up” to these missed cases. A new paper published Monday in JAMA Network Open suggests that didn’t happen as quickly as experts had hoped.
    • “Instead, the new analysis suggests that cancer diagnoses recovered to pre-pandemic levels by the end of 2021 — but didn’t make up for any of the lost cases from earlier in the pandemic. That leaves a troubling mystery for epidemiologists, as it means experts still don’t know what happened with the roughly 130,000 cancer cases that were missed in 2020.
    • “It’s still an unwritten story as to what exactly is going on,” said Uriel Kim, a population health scientist at Case Western Reserve University and the lead author on the study.”
  • Per Beckers Hospital Review,
    • Effective Sept. 10, the FDA required healthcare facilities providing breast imaging services to notify patients of their breast density in mammography reports. Now, some experts are expressing concern over the new mandate, according to an Oct. 12 report from NBC News. 
    • The majority of concerns stem from the lack of guidance over how to proceed once a patient has been identified as having dense breasts, particularly recommendations on additional imaging procedures. 
    • “You cannot counsel an entire population of women with dense breasts with one policy that’s going to be appropriate for everybody,” Mark Pearlman, MD, emeritus professor at Ann Arbor-based University of Michigan Medical School, told NBC News.
  • The American Medical Association lets us know what doctors wish their patients knew about ADHD in children.
  • Per Healio,
    • “Researchers observed an increase in heart rate and atrial tachycardias as alcohol consumption increased in young adults.
    • “Some participants experienced notable arrhythmia episodes including atrial fibrillation.”
  • MedPage Today notes,
    • “More than $100 million could be saved annually on discarded lecanemab (Leqembi), a simulation study suggested.
    • “Current vial sizes may result in 5.8% of the Alzheimer’s disease drug being thrown away, representing $1,619 in wasted Medicare spending per patient per year, reported researchers led by John Mafi, MD, MPH, of the David Geffen School of Medicine at UCLA.
    • “This translates to an estimated $133 million to $336 million worth of lecanemab discarded every year, assuming uptake rates of 1.1% to 2.9%, Mafi and co-authors said in a JAMA Internal Medicine research letter.”
  • Consumer Reports, writing in the Washington Post, advises year-round use of sunscreen products by adults.
    • “You’ve probably heard that the sun does most of its dirty work on our skin when we’re children. Even though that myth was debunked decades ago, the idea persists. That may be why only 57 percent of people 55 and older use sunscreen when they’re in the sun, according to a March CR nationally representative survey of 2,000 U.S. adults. And 14 percent of older adults don’t take any steps to protect their skin from the sun.
    • “That’s a mistake. “Sun damage is cumulative,” says Henry Lim, a dermatologist at Henry Ford Health in Detroit. “If you continue to expose your skin to the sun’s ultraviolet rays, the damage will continue — no matter what age you are.”
    • “Taking action now can help protect your skin from further harm and possibly even reverse some damage. The first step: finding an effective sunscreen, one you don’t mind wearing every day.”

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “Hospitals across the United States are reeling from a shortage of IV fluids after Hurricane Helene struck a major manufacturing plant in North Carolina, prompting some to postpone elective surgeries and others to conserve supply by restricting use.
    • “The Food and Drug Administration formally declared a shortage for three fluid products Friday, allowing some hospitals and facilities to manufacture their own supply. The FDA last week had allowed shipments of IV fluids from other countries. But complications make it difficult to immediately end the shortage.
    • “Compounding facilities that typically don’t manufacture IV fluids need access to sterile water and supplies such as bags to make their own products. The American Hospital Association estimates less than a fifth of hospitals are able to do so.
    • “If you turn off a hospital supply of IV fluids, it’s like turning off the water supply to your house,” Chris DeRienzo, the hospital association’s chief physician executive, said. “We need to have a continuous, consistent flow to the hospitals, especially as we are walking into the winter respiratory virus season.”
  • The American Hospital Association News adds,
    • “As part of its regular updates on the IV solution supply disruption as a result of the temporary closure of a manufacturing plant in North Carolina, Baxter Oct. 14 launched a new webpage with resources that hospitals can use for product management and conservation strategies. The webpage contains resources from Baxter, the federal government and other groups. In addition, Baxter said shipments to the U.S. from two Baxter sites abroad that were already able to export products “started last week and more are on the way.” The AHA is continuing efforts on multiple fronts to provide updates and assist members related to the supply chain issues caused by damage from Hurricane Helene.
  • Beckers Payer Issues ranks payers by average Medicare Stars scores.
  • WTW explains why the annual enrollment period / open season is a perfect opportunity to build a more resilient workforce.
  • STAT News tells us,
    • “Biotech investors have been buzzing around new areas of drug development this year, such as the red-hot obesity market. But there’s one field that has seen an even more significant amount of activity: autoimmune diseases.
    • “Companies that are developing new medicines for autoimmune conditions, as well as other immune system disorders, have brought in more money and closed more deals so far this year than most other areas, including the cardiometabolic field, data from investment bank Oppenheimer show. (Oncology remains king when it comes to investment, driven in part by interest in new approaches like radiopharmaceuticals).
    • “In the first half of 2024, venture capitalists pledged more than $1.7 billion to companies developing treatments for conditions in which the body’s own immune system goes haywire, attacking healthy cells and tissues and causing widespread damage. If the trend continues, autoimmune companies could raise double the amount of money that they raised at the height of the biotech market in 2021, according to data compiled by HSBC.
    • “Ask investors why, and most will point to research that’s come out of a German academic laboratory in the last two years, showing that a treatment called CAR-T can potentially reset the immune system in patients with lupus and other conditions.  
    • “That was revolutionary in the field, because … it was unexpected data that no one had ever seen,” said Arjun Goyal, managing director at Vida Ventures. Others described it as an earthquake that shook people to attention. One executive told STAT that his wife, a rheumatologist specializing in lupus, commented that the research could put her out of work.”
  • Per MedTech Dive,
    • “Danish drugmaker Lundbeck has agreed to spend $2.6 billion acquiring a young biotechnology company with an experimental brain medicine that could become a blockbuster product.
    • “The acquisition, announced Monday, has Lundbeck paying $60 in cash for each outstanding share of Longboard Pharmaceuticals, a 54% premium to the biotech’s stock price Friday. The companies expect their deal to close before the end of the year.
    • “Should it go through, the deal would hand Lundbeck a possible treatment for a series of rare brain disorders characterized by seizures and developmental delays. There are more than 20 types of these disorders, known as developmental and epileptic encephalopathies, or DEEs. And according to Lundbeck, they affect around 220,000 people in the U.S., half of whom don’t have an approved therapy to try.
    • “Lundbeck thinks the answer to that problem lies in a Longboard drug called bexicaserin. The drug entered late-stage clinical testing last monthfor one of the more prominent DEEs, Dravet syndrome, and is also being evaluated against another, Lennox-Gastaut syndrome. But Lundbeck believes it has the ability to address all DEEs and estimates the peak annual sales potential could reach $1.5 billion to $2 billion.”