Tuesday Tidbits

NIH

Tuesday Tidbits

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

From Washington, DC,

  • The Washington Post reports,
    • “Republican lawmakers returned to Capitol Hill on Tuesday with some spring in their step.
    • After winning the presidency and the Senate majority, the party is on the cusp of regaining the House majority — and with it, a powerful governing trifecta in Washington.
    • “Though control of the House may not be called for days, GOP lawmakers will this week work on the assumption they’ve clinched it, pushing ahead with House leadership elections and shaping plans to reverse or overhaul much of the Biden administration’s domestic and foreign policy.
    • “Though control of the House may not be called for days, GOP lawmakers will this week work on the assumption they’ve clinched it, pushing ahead with House leadership elections and shaping plans to reverse or overhaul much of the Biden administration’s domestic and foreign policy.”
  • The Post must be tracking the AP results (214 – 206) because Decision Desk HQ has decided that the Republicans do have a majority of seats in the House (219 – 210, 218 being a majority).
  • The Wall Street Journal reports,
    • “President-elect Donald Trump picked Tesla CEO Elon Musk and biotech company founder Vivek Ramaswamy, a former Republican presidential candidate, to lead an effort to cut spending, eliminate regulations and restructure federal agencies.
    • “Trump said in a statement Tuesday night that Ramaswamy and Musk—the wealthiest person in the world, who oversees six companies including Tesla—would lead what the president-elect called the Department of Government Efficiency, or DOGE. The department’s mandate is to streamline government bureaucracy, the president-elect said.
    • “DOGE will operate outside of the federal government, Trump said, and will work with the White House Office of Management and Budget to implement its recommendations.” 
  • The American Hospital Association News lets us know,
    • “In comments Nov. 12 to majority and minority leaders of the House and Senate, the AHA requested that Congress act on key priorities for hospitals and health systems before the end of 2024. AHA urged Congress to continue providing relief from Medicaid Disproportionate Share Hospital Payment cuts; continue the Medicare-dependent Hospitals and Low-volume Adjustment programs that expire Dec. 31; reject site-neutral payment proposals; and pass the Improving Seniors’ Timely Access to Care Act (H.R. 8702/ S. 4532), legislation that would reduce the wide variation in prior authorization methods in the Medicare Advantage program.” * * * 
    • “AHA also urged Congress to extend the hospital-at-home waiver for five years through 2029; mitigate scheduled physician reimbursement cuts for 2025; and pass the Safety from Violence for Healthcare Employees Act (H.R. 2584/S. 2768), legislation that would provide federal protections from workplace violence for hospital workers, similar to protections for airport and airline workers.”
  • and
    • “The Centers for Medicare & Medicaid Services Nov. 12 released a report evaluating past and present approaches to rural health. It shares how previous CMS Innovation Center models focusing on rural health have been applied to recent model development. 
    • “The report also shares themes, concepts and next steps gathered from its rural health “Hackathon,” a series of events across the U.S. that brought experts together to brainstorm solutions to rural health challenges. The top themes highlighted a need for training, regulatory changes and collaboration to help improve access to care and support transformation. The report also outlines possible considerations for future Accountable Care Organization-focused and other models.
    • “CMS’ next intention is to issue a request for application to fill the 10 open spaces for its Rural Community Hospital Demonstration. The program was directed by Congress and requires a test of cost-based payment for Medicare inpatient services for rural hospitals with fewer than 51 beds that are ineligible for critical access hospital status.”
  • OPM issued a press release today about the ongoing Open Season while Govexec informs us,
    • “Retired and active federal employees find selecting a health care plan to be more confusing than creating a will, reading Shakespeare, learning a new language or navigating a divorce, according to a new survey from the National Active and Retired Federal Employees Association. 
    • “While the process may be complex, NARFE is urging current and former federal and postal employees to look at their options for health care insurance carriers and coverage plans during this year’s open season, which lasts from Nov. 11 through Dec. 9, especially in light of premium price increases next year that will be the largest in recent memory. 
    • “John Hatton, NARFE’s staff vice president of policy and programs, told Government Executive that enrollees could be missing out on thousands of dollars in savings. 
    • “We always recommend people to take a look at their options during open season to make sure they have the coverage that they need so they’re not paying more in out-of-pocket expenses later, but also to pay less in premiums if they don’t need the coverage that they currently have,” he said. 
    • “More than half of active federal employees (57%) and retired ones (55%) in NARFE’s survey annually review their health insurance options. For this year’s open season, 60% of current feds responded that they are planning on participating compared to 47% of retirees.” 
  • RAND shares survey results about U.S. veterans’ families, which should be of interest to FEHB carriers as the federal government wisely hire a lot of veterans.
  • Meanwhile, AHIP fact checks a Wall Street Journal article criticizing the Medicare Advantage program.
  • The New York Times reports,
    • “The Justice Department and four Democratic state attorneys general on Tuesday filed an antitrust lawsuit against the giant UnitedHealth Group in an attempt to block its $3.3 billion deal to take over Amedisys, a large home health company.
    • “Unless this $3.3 billion transaction is stopped, UnitedHealth Group will further extend its grip to home health and hospice care, threatening seniors, their families and nurses,” Jonathan Kanter, the assistant attorney general who heads the department’s antitrust division, said in a statement on Tuesday.“
  • The Wall Street Journal adds,
    • “Johnson & Johnson launched a legal challenge against a federal health agency blocking the company’s quest to tighten the way it provides lucrative drug discounts to hospitals.
    • “J&J filed a lawsuit in federal court in Washington on Tuesday against the heads of the U.S. Department of Health and Human Services and one of its agencies, seeking a court ruling that says J&J’s plan is legal and to prevent the agency from rejecting it.
    • “The lawsuit escalates the pharmaceutical industry’s fight to rein in the federal drug-discount program known as 340B. The program, created in 1992, requires drugmakers to provide steep discounts on outpatient drugs to hospitals and clinics that serve uninsured and low-income patients. 
    • “The pharmaceutical industry has argued that the 340B program has strayed from its original purpose of helping safety-net hospitals. Manufacturers say they sell medicines to covered hospitals at steep discounts, but some large hospitals mark up the prices charged to both uninsured patients and insurers.”

From the public health and medical research front,

  • The New York Times reports,
    • “After decades of unrelenting increases, rates of sexually transmitted infections in the United States are showing hints of a downturn.
    • “Diagnoses of gonorrhea dipped in nearly all age groups last year, compared with 2022, and new cases of syphilis and chlamydia remained about the same, according to data released on Tuesday by the Centers for Disease Control and Prevention.
    • “The results are not yet cause for celebration.
    • “Overall, more than 2.4 million new S.T.I.s were diagnosed last year, about a million more than the figure 20 years ago. Nearly 4,000 babies were diagnosed with congenital syphilis last year, and 279 of them were stillborn or died soon after.
    • “Still, experts said they were cautiously optimistic that a resurgent tide of infections was beginning to turn.”
  • Per a National Institutes of Health press release,
    • “Researchers at the National Institutes of Health (NIH) and their collaborators have discovered a new way in which RAS genes, which are commonly mutated in cancer, may drive tumor growth beyond their well-known role in signaling at the cell surface. Mutant RAS, they found, helps to kick off a series of events involving the transport of specific nuclear proteins that lead to uncontrolled tumor growth, according to a study published Nov. 11, 2024, in Nature Cancer.
    • “RAS genes are the second most frequently mutated genes in cancer, and mutant RAS proteins are key drivers of some of the deadliest cancers, including nearly all pancreatic cancers, half of colorectal cancers, and one-third of lung cancers. Decades of research have shown that mutant RAS proteins promote the development and growth of tumors by activating specific proteins at the cell surface, creating a constant stream of signals telling cells to grow.” * * *
    • “The study also found evidence that mutant RAS proteins perform this same function in other cancer types, suggesting that this mechanism may be a general feature of cancers with mutated RAS genes.
    • “The researchers believe their finding may have potential applications for the treatment of RAS-fueled cancers. They have started to look at how this function for RAS works in pancreatic cancer in particular because there are so few effective treatments for this type of cancer.
    • “New treatment combinations could one day be developed that take this new role for RAS into consideration,” Dr. [Douglas] Lowy said.”
  • Health Day tells us,
    • “Lives lost to obesity-related heart disease have nearly tripled over the past twenty years, a new study reports.
    • “Heart disease deaths linked to obesity increased 2.8-fold between 1999 and 2020, according to findings presented today at the American Heart Association’s annual meeting in Chicago.
    • “The increase occurred especially among middle-aged men, Black adults, Midwesterners and rural residents, researchers found.
    • “Obesity is a serious risk factor for ischemic heart disease, and this risk is going up at an alarming rate along with the increasing prevalence of obesity,” lead researcher Dr. Aleenah Mohsin, a post-doctoral research fellow at Brown University in Providence, R.I., said in a news release.” * * *
    • “The National Institute of Health has more on the health risks of obesity.”

From the U.S. healthcare business front,

  • Fierce Healthcare surveys the major payors’ third quarter financial results as the curtain falls on the third quarter announcement season.
  • Kaufmann Hall relates,
    • “Though most indicators were down, hospital performance remained relatively stable overall, according to September data. Both inpatient revenue and average lengths of stay increased.
    • “The recent issue of the National Hospital Flash Report covers these and other key performance metrics.”
  • and
    • “In the third quarter of this year, the median investment/subsidy per physician was $304,312—rising above $300,000 for the first time. Other expense metrics such as the total direct expense per provider FTE and labor as a percentage of total expenses increased.
    • “The Physician Flash Report features the most up-to-date industry trends drawn from the same data physician groups use to track their finances and operations.”
  • Per Modern Healthcare,
    • “Ochsner Health may expand its hospital-at-home program throughout the entire health system after successfully piloting a program in New Orleans, the nonprofit healthcare provider said Tuesday.
    • “Ochsner Health said in a news release the pilot, launched in March at Ochsner Medical Center-New Orleans, prevented either initial hospitalizations or 15-day hospital readmissions for 92% of the patients referred to the program through its emergency department and observation unit.
    • “The New Orleans-based health system offered the service through a partnership with myLaurel, a New York-based company that provides transitional and acute care to frail, elderly patients at home instead of a hospital. Patients received virtual and in-home visits from clinicians, along with lab work, medications, education about treatment plans and other services.”
  • and
    • “Cardinal Health has entered definitive agreements to acquire a majority stake in GI Alliance, a gastroenterology management services organization, and the entirety of Advanced Diabetes Supply Group, a diabetes medical equipment supplier. 
    • “Cardinal expects to acquire Advanced Diabetes Supply for an estimated $1.1 billion and 71% ownership of GI Alliance for an estimated $2.8 billion. Both deals are expected to close by early 2025, pending regulatory approvals.” 
  • STAT News relates
    • “23andMe, the genetics startup that has repeatedly captured the public imagination and then faced nearly fatal business challenges, announced Monday that it would halt its efforts to develop new medicines and lay off 40% of its workforce, focusing instead on selling genetic tests to consumers and using the resulting data for research.
    • “In closing its therapeutics division and laying off 200 people, 23andMe ended an audacious bet it made nearly a decade ago — that it could use the genetic data it had collected not only to assist drug companies but to become one itself.”
  • Per Healthcare Dive,
    • “General Catalyst released new details on its planned acquisition of Akron, Ohio-based Summa Health on Thursday, roughly one year after the venture capital firm said it was looking to buy a health system. 
    • “General Catalyst’s Health Assurance Transformation business, or HATCo, has signed a definitive agreement to purchase Summa for $485 million. The deal, alongside the health system’s current cash on hand, allows Summa to eliminate $850 million in debt — nearly all the debt the health system currently holds, according to Summa’s most recent financial results.
    • “HATCo is also pledging to spend $350 million over the first five years of its ownership to support routine operations and technology investments, plus another $200 million over seven years for “strategic and transformative” initiatives.” 
  • Per MedTech Dive,
    • “Johnson & Johnson said Tuesday it received an investigational device exemption (IDE) from the Food and Drug Administration to start a U.S. clinical trial for its Ottava surgical robot.
    • “The company said it will now prepare U.S. sites to receive Ottava systems, enroll patients and begin surgical cases as it focuses on training clinical trial investigators. J&J’s soft tissue robot will compete with Intuitive Surgical’s da Vinci system, which currently leads the market.
    • “The Ottava platform will incorporate J&J Ethicon surgical instruments designed for the robotic platform, the company said. Ottava will also have a digital system called Polyphonic that will connect surgical technologies, robotics and software, ultimately adding data and insights to support clinical decision making.”
  • and
    • “GE Healthcare has struck a deal to combine its Senographe Pristina mammography system with Radnet’s artificial intelligence-based Smartmammo workflow, the companies said Monday.
    • “The alliance positions GE to distribute Radnet software designed to help mammography centers view images, prioritize cases and support other steps in the workflow. The integration is the first part of a broader collaboration focused on imaging AI.
    • “Radnet CEO Howard Berger told analysts on an earnings call Monday that the mammogram systems “simply need a power source and a connection to the internet,” creating opportunities to image patients in “Walmart and mall locations.”

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.”

Happy Halloween

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Update

David Ermer–Congress, FDA, Medical / Rx research, NIH, No Surprises Act–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • MedPage Today tells us,
    • “A bipartisan group of House members introduced a bill Tuesday that would reverse a proposed 2.8% Medicare Physician Fee Schedule payment cutopens in a new tab or window and give physicians a raise equivalent to half of the increase in the Medicare Economic Index (MEI), a measure of healthcare inflation.
    • “America’s physicians are at a breaking point and access to high-quality, affordable care is at risk for millions of Medicare patients,” Rep. Greg Murphy, MD (R-N.C.), one of the bill’s co-sponsors, said in a statement. “When a physician sees a Medicare patient, they do so out of the goodness of their heart, not because it makes financial sense … Unfortunately, reimbursements continue to decline, putting immense pressure on doctors to retire, close their practices, forgo seeing new Medicare patients, or seek a less efficient employment position. This bipartisan legislation would stop yet another year of reimbursement cuts, give them a slight inflationary adjustment, and protect Medicare for physicians and patients alike.”
  • Roll Call lets us know,
    • ​”With all eyes on next week’s elections, appropriations battles are simmering on the back burner for Congress. But lawmakers won’t have long to make some tough decisions when they return starting on Nov. 12 for the lame-duck session.
    • “The priorities are twofold: first, passing an emergency relief package after two major hurricanes battered the Southeast, compounding pent-up demands for disaster aid going back to last year. Second, congressional leaders need to figure out what to do about funding the government beyond the stopgap law’s Dec. 20 deadline.
    • ‘The current betting is that there simply won’t be enough time in the five weeks of session remaining to strike the deals needed to put together thousands of pages of text fleshing out a dozen full-year fiscal 2025 spending bills. Top Democrats and appropriators on both sides of the Capitol will push that option, but without GOP leadership buy-in, it’s very unlikely.”
  • Today the U.S. Court of Appeals for the Fifth Circuit handed a loss to the Texas Medical Association (TMA) in the No Surprises Act cases.
    • The Court summarized its holdings as follows
      • “We conclude that the provisions of the Rule related to QPA calculations are lawful and therefore REVERSE the district court’s holdings as to those provisions. We further conclude that the Rule’s deadline provision is unlawful and therefore AFFIRM the district court’s holding as to that provision. Finally, we conclude that the Rule’s disclosure requirements are lawful and therefore AFFIRM the district court’s holding as to those provisions.”
    • The first and third holdings are the TMA loss.  Last December, CMS implemented the district court’s QPA calculation decision in its NSA guidance.  The FEHBlog imagines that CMS may reverse that December 2023 guidance soon.
    • The second holding means that health plans must pay or deny an NSA claim within 30 calendar days after receipt. The clean claim consideration was rejected by the district court and the court of appeals. 

From the public health and medical research front,

  • The Washington Post reports,
    • “The bird flu outbreak in dairy cows has spread to at least one pig on a backyard farm in Oregon, the first detection of the H5N1 virus in swine in the United States, the U.S. Department of Agriculture said Wednesday.
    • “The discovery is particularly concerning to scientists and public health officials because pigs can become coinfected with bird and human viruses, allowing genes to swap to form a new, more dangerous virus that can more easily infect humans.
    • “Bird flu was first detected in poultry on the noncommercial farm, the Oregon agriculture department said Friday. The USDA’s National Veterinary Services Laboratories confirmed that one of the farm’s five pigs was infected with the virus on Tuesday but did not publicize the discovery until Wednesday.” * * *
    • “Once an avian virus like H5N1 gets into a pig, it can mix with other viruses — a process known as reassortment — and pick up the ability to grow better and adapt to make humans sicker, Webby said. At least 31 people have been sickened in the current bird flu outbreak, all with mild symptoms.
    • ‘Animals on the farm are not part of the commercial food supply, the USDA said. The discovery of bird flu in the swine has no impact on the safety of the nation’s pork supply.
    • “The farm’s small size gives the virus less opportunity to spill into humans, experts said.”
  • The New York Times informs us,
    • “The blockbuster drug semaglutide, sold as Ozempic for diabetes and as Wegovy for weight loss, now has a new proven benefit: It markedly soothed knee pain in people who are obese and have moderate to severe osteoarthritis, according to a large study.
    • “The effect was so pronounced that some arthritis experts not involved with the clinical trial were taken aback.
    • “The magnitude of the improvement is of a scope we haven’t seen before with a drug,” said Dr. Bob Carter, deputy director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. “They had an almost 50 percent reduction in their knee pain. That’s huge.”
    • “Dr. David T. Felson, an arthritis expert and professor of medicine at Boston University School of Medicine, said the study “changes the landscape,” adding that the pain reduction is greater than anything that can be achieved short of knee replacement surgery.”
  • and
    • “For decades, people with failing heart valves who nevertheless felt all right would walk out of the cardiologist’s office with the same “wait and see” treatment plan: Come back in six or 12 months. No reason to go under the knife just yet.
    • “A new clinical trial has overturned that thinking, suggesting that those patients would be much better off having their valves replaced right away with a minimally invasive procedure.
    • The trial, whose results were published this week in The New England Journal of Medicine, could change the way doctors treat severe aortic stenosis, a narrowing of the valve that controls blood flow from the heart. The disease, which has a prognosis worse than that of most cancers, afflicts more than 3 percent of people ages 65 and older. It is expected to become more common as people live longer.
    • “Replacing people’s heart valves, even if they were not yet experiencing any ill effects, appeared to roughly halve their risk of being unexpectedly hospitalized for heart problems over at least two years, the trial found.”
  • The Wall Street Journal adds,
    • “It is hard to mend a broken heart, but in a few years doctors might be able to do essentially that.
    • “Scientists are closing in on ways to help patients grow new heart muscle after a heart attack, as well as new lung tissue to treat fibrosis, corneas to erase eye pain and other body parts to gain a new chance at life.
    • “If the science works, it could represent a new approach to medicine: reversing rather than alleviating chronic illnesses.”
    • “The idea “is really to restore function to the organ such that the quality of life of that person is normalized,” says Peter Schultz, president and chief executive of Scripps Research, a nonprofit scientific institute in La Jolla, Calif., that is testing medicines to regenerate hearts, lungs and other organs.
    • “These treatments eventually might also be used to reverse the effects of aging, Schultz says. If they prove effective in people with disease, he says, they could be tested in healthy people to see if they can, say, “turn a 70-year-old heart into a 40-year-old heart.”
  • STAT News relates,
    • “An experimental Alzheimer’s therapy from Roche successfully cleared a protein that’s a hallmark of the disease from patients’ brains, the company reported Wednesday, adding to evidence that the drug shows promise.
    • “The data are from an early-stage trial and so far, Roche has not yet assessed whether there has been any corresponding change in cognitive function or disease progression. But U.S. regulators have in recent years approved similar medicines that can reduce levels of the protein, called amyloid, in patients’ brains and that in trials modestly slowed the worsening of Alzheimer’s.
    • “What’s more, the early findings of Roche’s treatment, an antibody called trontinemab, suggest it could be safer than some of the other amyloid-clearing treatments, although larger studies would need to confirm that. In particular, there have been comparatively few cases of an issue called ARIA, a type of brain swelling or bleeding, that has been seen with the other antibodies and that has led regulators in some parts of the world to take negative views of the existing drugs.”
  • Beckers Hospital Review alerts us,
    • “A recent study revealed a 17.5% increase in asthma-related hospitalizations in the three months following the announcement that GSK would discontinue the widely used asthma medication Flovent, and 24.1% in the following three to six months, ABC News reported Oct. 30. 
    • “The research, conducted by EPIC Research, analyzed data from over 3 million patients and highlighted the potential risks associated with the switch to alternative medications. 
    • ‘Five-year-old Burton Hayes, whose asthma was previously well managed on Flovent, faced significant health challenges after his mother was forced to switch his medication, ABC News reported. Reports indicated a sharp rise in asthma exacerbations among patients following the discontinuation, leading to an increase in emergency room visits and hospital admissions. 
    • “The decision to halt Flovent’s production came after a Federal Trade Commission warning about its patent. To comply with regulatory changes and avoid potential financial penalties, GSK shifted to an authorized generic, fluticasone propionate. However, many patients are finding that the new generic is not covered by insurance, complicating access, according to the ABC News report.”
  • CIGNA points out “fifteen stats illustrating cancer’s impact on people, employers, and health care costs.”
  • Per an NIH press release,
    • “New insights from multiple studies provide critical information on how cancer tumors develop, spread, and respond to treatments. The 10 studies from the Human Tumor Atlas Network (HTAN), a National Institutes of Health (NIH)-funded Cancer Moonshot℠ initiative to construct three-dimensional maps of human tumors, will be published Oct. 31, 2024, across several Nature journals.
    • “Several studies explore the role of the tumor microenvironment and the immune system in promoting the spread of cancer and its resistance to treatment. Three studies map the trajectory of precancerous colorectal tissues toward cancer by measuring the contributions of multiple molecular and cellular events. Multiple new HTAN papers describe the development of innovative single-cell technology and analysis platforms. An accompanying research briefing by W. Kimryn Rathmell, M.D., Ph.D., director of NIH’s National Cancer Institute (NCI), and Dinah Singer, Ph.D., NCI deputy director for scientific strategy and development, discusses the history, progress, and future of HTAN.
    • “Launched in 2018, HTAN constructs three-dimensional maps of human tumors that capture their molecular features and surrounding microenvironments over time. The work is being done by teams of investigators from research institutions across the country using a variety of technologies and computational approaches to study tumors at the single-cell level. This comprehensive, publicly available resource aims to help researchers better understand the development and progression of cancer to inform its prevention and treatment. The first tumor atlas studies from this initiative were published in 2020 and 2021.” * * *
    • “The collection page is available at https://www.nature.com/collections/fihchcjehc.”

From the U.S. healthcare business front,

  • Healthcare Dive points out,
    • “Actions taken by Humana to weather tumult in the Medicare Advantage program appear to be bearing fruit. On Wednesday, the insurer reported better-than-anticipated third quarter results and modestly increased its 2024 earnings guidance after retaining more MA seniors than expected — and those members having higher risk scores, boosting reimbursement.
    • “Humana now expects to add 265,000 individual MA members this year, representing 5% growth, compared to its previous guidance of 225,000 new MA members.
    • “Despite the stronger membership, Humana doesn’t expect earnings growth in 2025 because of heavy investments the insurer plans to make to boost its MA stars — valuable quality ratings linked to plans’ revenue in the privatized Medicare program.”
  • Per BioPharma Dive,
    • “Eli Lilly’s seemingly inexorable growth hit a speed bump Wednesday, when the Indianapolis drugmaker reported earnings for the third quarter that missed Wall Street expectations and sent shares down sharply.
    • “Overall, revenue reached $11.4 billion between July and September, up 20% from the same period last year but higher by only 1% versus the second quarter and well below the consensus forecast of about $12.1 billion.
    • “Lilly’s sales and stock price have swelled on surging demand for the company’s GLP-1 medicines Mounjaro and Zepbound, which it respectively sells for diabetes and obesity.
    • “The company has had difficulty meeting that demand, though, leading to shortages that have hampered the drugs’ availability. (In October, the Food and Drug Administration officially removed Mounjaro and Zepbound from its shortage list, but is now reconsidering that decision.)
    • “Compared to the third quarter last year, sales of the two drugs are significantly higher, respectively reaching $3.1 billion and $1.26 billion during the period. But both totals were lower than analysts expected and roughly flat compared to the second quarter.”
  • and
    • “All doses of Novo Nordisk’s popular GLP-1 medicines Ozempic and Wegovy are available in the U.S. and being regularly shipped to wholesalers, the drugmaker confirmed Wednesday.
    • “One dose form or another of both drugs, which respectively treat diabetes and obesity, has been in shortage since March 2022, according to a database maintained by the Food and Drug Administration. The database was updated Wednesday to reflect the drugs’ new availability, although both remain listed.
    • “In an emailed statement, Novo cautioned that, “even when a medication is available, patients may not always be able to immediately fill their prescription at a particular pharmacy.” The statement added that people seeking to fill a prescription may experience this “variability” regardless of whether a drug is actively in shortage.”
  • Per Fierce Pharma,
    • “It’s a new era for AbbVie. For the first time in years, the company has a new top sales driver as Skyrizi has overtaken Humira in quarterly sales.
    • “Humira heir Skyrizi has been slowly creeping up on the once-dominant Humira ever since biosimilar competition prompted the immunology king’s decline. With Skyrizi salesskyrocketing 50% to $3.2 billion during the third quarter, the drug took the sales crown from Humira, which has been trending down and generated $2.2 billion during the period.
    • “Skyrizi holds biologic share leadership in approximately 30 countries and boasts a “best-in-class profile” that presents a “very high bar” for rivals, AbbVie’s chief commercial officer Jeffrey Stewart said on the company’s third-quarter earnings conference call.
    • “After Skyrizi’s recent debut in ulcerative colitis, feedback and initial prescription trends have been “overwhelmingly positive,” Stewart added. The crowded ulcerative colitis market recently gained another competitor in Johnson & Johnson’s Tremfya, setting up a fierce fight for dominance between the pharma giants. However, Skyrizi has a leg up with its prior Crohn’s disease nod, which represents the second form of inflammatory bowel disease (IBD).”
  • Fierce Healthcare tells us,
    • “Online therapy company Talkspace grew its revenue 23% in the third quarter, bringing in $47.4 million, and turned last year’s net loss into a profit of $1.9 million.
    • “The company continues to expand its business with payers and employers and now covering 158 million people in-network and through Medicare/Medicare Advantage plans, an increase of 40% year-over-year, Talkspace announced in its third-quarter earnings report released Tuesday. As Talkspace grows, it is increasing access to virtual behavioral health services for seniors, teens and members of the U.S. military, exectives said.
    • “This past quarter marks Talkspace’s third consecutive quarter of adjusted EBITDA profitability. Adjusted EBITDA came in at $2.4 million in Q3, an improvement from a loss of $2.8 million a year ago and beating Wall Street analysts’ consensus estimate of $1.4 million.”
  • Beckers Payer Issues identifies “the investments 18 payer executives are most excited about.” Check it out.

Tuesday Tidbits

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

From Washington, DC

  • MedPage Today tells us,
    • “A majority of House members urged House leaders to not only reverse a proposed 2.8% cut in the Medicare Physician Fee Schedule (MPFS), but also to pass a law that would avoid such cuts in the future.
    • “Increased instability in the healthcare sector due to looming cost hikes impacts the ability of physicians and clinicians to provide the highest quality of care and threatens patient access to affordable healthcare,” read a bipartisan letter signed by 233 House members and spearheaded by Reps. Mariannette Miller-Meeks, MD (R-Iowa) and Jimmy Panetta (D-Calif.). “In lieu of these harmful cuts, which, absent federal legislation, will take effect on January 1, 2025, Congress must pass a bill providing physicians and other clinicians with a payment update that takes into account the cost of actually delivering care to patients.” The letter, which was dated October 11 and made public on Tuesday, was sent to House Speaker Mike Johnson (R-La.) and House Minority Leader Hakeem Jeffries (D-N.Y.).”
  • KFF issued a report on trends in Medicaid outpatient prescription drug spending. Medicaid drug spending is a bellwether because federal law requires that Medicaid receives best pricing from drug manufacturers.
  • The Wall Street Journal offers advice on navigating the Medicare open enrollment period which began today.

From the public health and medical research front,

  • Beckers Hospital Review tells us,
    • “Baxter International started to import IV fluids last week from two of its international manufacturing facilities to address supply shortages in the U.S. 
    • “In coordination with HHS, the FDA and the Administration for Strategic Preparedness and Response, Baxter said it has activated seven plants globally to increase inventory. Recent FDA authorization permits the temporary importation from five Baxter facilities located in Canada, China, Ireland and the U.K., covering 19 IV solution and dialysis production codes. 
    • “The company is also ramping up production and utilizing air and other transportation methods to expedite delivery, according to an Oct. 14 update from the company.”
  • The Washington Post offers more details on “10 million pounds of meat recalled over listeria concern. BrucePac, which produces precooked meat and poultry items, is recalling some products from retailers including Walmart, Target, Aldi, Trader Joe’s and Kroger.”
  • STAT New shares eleven expert opinions “on why gains in cardiovascular disease are stalling and what we can do about it.”
    • “[T]he consensus of the experts interviewed — including Pinney — is that heart disease is far higher than it should be given the tools we have. This is compounded by a disconnect that has formed in the public’s mind between threat and perception. This year, an American Heart Association survey revealed that just over half of Americans are unaware that heart disease remains the leading cause of death, outstripping cancer. 
    • “Nor are most people aware of the vulnerability of particular groups.  “People don’t know that cardiovascular disease is actually the leading cause of mortality in pregnant or postpartum women,” said Janet Wei, assistant medical director of the Biomedical Imaging Research Institute at Cedars-Sinai Medical Center in Los Angeles.
    • “If current trends continue, the heart association estimates, by 2050 at least 6 in 10 U.S. adults will live and die with cardiovascular disease of some type, reflecting an older population burdened by high blood pressure and obesity, despite what we know about those conditions predicting disease.”
  • The Washington Post reports on “digital twinning” of human body organs.
    • “Doctors can create a “digital twin” of your heart and other organs to reduce guesswork during surgery. The technology may transform health care.
    • “Digital twinning has come of age in medicine during the last several years, moving into models for lungs, livers, brains, joints, eyes, blood vessels and other body parts. A virtual twin of an entire human being is somewhere in the future. The technology is also being used to test new medical devices and even drugs, with computer models powerful enough to predict a new molecule’s impact on organs and cells. It holds the potential to scale back, or even replace, the use of animals in experiments and humans in clinical trials.
    • “The technology “is revolutionary,” said Ellen Kuhl, a Stanford University professor of engineering, who is modeling the way a heart translates electrical impulses into physical pumping. “If you do this right, the models you create generalize to a wide population.”
  • Per NIH press releases,
    • “Alzheimer’s disease may damage the brain in two distinct phases, based on new research funded by the National Institutes of Health (NIH) using sophisticated brain mapping tools. According to researchers who discovered this new view, the first, early phase happens slowly and silently — before people experience memory problems — harming just a few vulnerable cell types. In contrast, the second, late phase causes damage that is more widely destructive and coincides with the appearance of symptoms and the rapid accumulation of plaques, tangles, and other Alzheimer’s hallmarks.
    • “One of the challenges to diagnosing and treating Alzheimer’s is that much of the damage to the brain happens well before symptoms occur. The ability to detect these early changes means that, for the first time, we can see what is happening to a person’s brain during the earliest periods of the disease,” said Richard J. Hodes, M.D., director, NIH National Institute on Aging. “The results fundamentally alter scientists’ understanding of how Alzheimer’s harms the brain and will guide the development of new treatments for this devastating disorder.”
  • and
  • NIH also shares “Research in Context: Can we slow aging?”
  • KFF released an issue brief about “Teens, Drugs, and Overdose: Contrasting Pre-Pandemic and Current Trends.”
    • “This issue brief analyzes CDC WONDER data – including provisional data from 2023 – and data from national surveys of adolescent youth to highlight trends in substance use and overdose deaths. It explores how and where teenagers receive substance use information and treatment and how school settings can be leveraged to enhance prevention measures. Lastly, it examines federal and state prevention efforts and social media’s role in the drug crisis.”

From the U.S. healthcare business front,

  • Healthcare Dive informs us,
    • “UnitedHealth Group lowered the top end of its adjusted profit guidance for 2024 on Tuesday as the healthcare giant continues to deal with the fallout from a cyberattack on subsidiary Change Healthcare.
    • “The company decreased its adjusted net earnings outlook to $27.50 to $27.75 per share for this year, compared with its previous $27.50 to $28 range. The updated guidance includes $0.75 per share in impacts from the cyberattack on technology firm and claims professor Change, about a $0.10 per share increase from UnitedHealth’s estimate last quarter. 
    • “But the insurer still beat investor expectations on revenue and earnings per share in the third quarter, driven by expansion in people served in UnitedHealthcare and its health services unit Optum.”
  • and
    • “CVS Health is discontinuing certain infusion services offered through its Coram business and also plans to close or sell 29 pharmacies in the coming months, a spokesperson confirmed to Healthcare Dive.
    • “The retail giant stopped accepting new patients for its antibiotics, inotropic medications, total parenteral nutrition and acute home infusion therapies programs last week. Coram will continue to provide infusion services for specialty medications and enteral nutrition. 
    • “CVS Health may conduct layoffs as part of the reduction in services. Impacted employees would be notified in mid-November and terminated in the new year, according to the spokesperson. Any workforce reductions are separate from CVS Health’s announcement last month that it would lay off 2,900 employees.”
  • and
    • “Continuing its belt-tightening, Walgreens will close about 1,200 storesover the next three years, starting with about 500 in the current fiscal year, which just commenced.
    • “That’s more than half the number of stores the drugstore retailer acquired from Rite Aid seven years ago, after they called off their planned merger.
    • “Retail operations were a drag on results: Q4 retail sales fell 3.5% year over year, with comps down 1.7%, while full-year retail sales fell 4.6%, with comps down 3.4%, per an earnings presentation. Beauty, seasonal and general merchandise siphoned about 150 basis points from Q4 comps, and elevated shrink levels offset positive impacts on retail adjusted gross margin from category mix and private labels.”
  • Per BioPharma Dive,
    • “Sales of Johnson & Johnson’s cancer therapy Carvykti and immune disease drug Tremfya grew strongly during the third quarter, the pharmaceutical company reported Tuesday, as new approvals helped broaden the two medicines’ market reach.
    • “The growth from Carvykti and Tremfya comes as J&J prepares for biosimilar competition to its second best-selling drug, Stelara, in January 2025. Biosimilars have already arrived in Europe and, alongside larger-than-expected insurer rebates, drove Stelara’s third quarter sales down 7% compared to last year.
    • “While analysts viewed the performance of J&J’s medical device division as underwhelming, J&J was still confident enough in its outlook to raise operational sales guidance for the full year slightly.”
  • Beckers Hospital CFO Report offers 22 statistics on inpatient length of stay.
    • “The average length of stay at hospitals across the U.S. is dropping slightly, while observation days have big declines year over year, according to Kaufman Hall’s National Hospital Flash Report. 
    • “The report includes data from 1,300 hospitals in August, which are tracked monthly for operational and financial trends. The length of stay dropped one to two percentage points on average for most hospitals, regardless of region and size. There was a wider variation in the observation days as a percentage of patient days, as patients are leaving the hospital quicker this year compared to last year.
    • “This development indicates less severe patient acuity and efficient care transition pathways,” the report authors noted.”

Thursday Miscellany

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

In hurricane news,

  • The New York Times reports,
    • “The Daytona Beach plant that makes nearly a quarter of the IV fluids used in the United States is intact in the wake of Hurricane Milton’s tear across Florida, according to a company spokeswoman.
    • “The site, operated by B Braun Medical, gained prominence this week as a backup source for IV solutions because Hurricane Helene had flooded a major producer of the fluids in North Carolina and left hospitals from California to Virginia with diminishing supplies.
    • “Company workers and officials from the federal Administration for Strategic Preparedness and Response took pre-emptive measures before Milton arrived, loading trucks full of finished IV medical products to ship them out of the storm’s reach through the night Tuesday. 
    • “Allison Longenhagen, a company spokeswoman, said on Thursday that the manufacturing and distribution site at Daytona Beach was intact, and would reopen on Friday.”
  • Healthcare Dive adds,
    • Hurricane Milton hit Florida’s West Coast hard Wednesday night as a Category 3 storm, bringing torrents of rain and tornadoes that caused millions to lose power and triggered widespread destruction to roads and water and sewage services.
    • While the region’s hospitals were largely ready for storm due to legacy hurricane preparations, health systems are still grappling with critical infrastructure outages and are making “hour-by-hour” calculations on whether to evacuate more patients, according to Mary Mayhew, CEO and president of the Florida Hospital Association.
  • Per MedTech Dive,
    • “Baxter said Wednesday it would increase allocation levels of certain IV fluids as the U.S. manages supply shortages after the company’s largest manufacturing plant was damaged by Hurricane Helene.
    • “The company increased allocation levels of its “highest demand” IV fluids from 40% to 60% for direct customers and from 10% to 60% for distributors, effective Wednesday, according to the update. Baxter also increased the allocation level of IV solutions and nutrition products for designated children’s hospitals to 100%.
    • “Baxter said its goal is to restart production at the North Carolina facility in phases and “return to 90% to 100% allocation of certain IV solution product codes by the end of 2024.”

From Washington, DC,

  • Fierce Healthcare lets us know,
    • “Just 40% of Medicare Advantage prescription drug plans offered in 2025 achieved a score of four stars or higher, the Centers for Medicare & Medicaid Services (CMS) revealed Oct. 10.
    • “It is the third consecutive year the portion of MA plans offering four-star plans or greater decreased, with 68% of plans meeting the threshold in 2022. Last year 42% of plans achieved at least a four-star rating.
    • “Weighted by enrollment, 62% of enrollees are currently in contracts with a four-star rating or better. In 2022, 90% of enrollees were in at least a four-star plan.
    • “These star ratings impact the 2026-year quality bonus payments, which has significant financial repercussions to MA plans. They are rated on 40 measures in Medicare Advantage Prescription Drug (MA-PD) plans, 30 measures for MA plans and only 12 measures in solely prescription drug plans.
  • Federal News Network tells us,
    • “The final piece of the puzzle fell into place Thursday morning for calculating the 2025 cost-of-living adjustment (COLA) for Social Security and federal retirement benefits.
    • “Starting in January, many federal retirees will see a 2025 COLA of 2.5% added to their Social Security benefits and federal retirement annuities — but not everyone will receive the full adjustment.
    • “Retirees in the Federal Employees Retirement System (FERS) usually receive a smaller cost-of-living adjustment each year for their annuities, though the exact difference depends on how big the COLA is in a given year:
      • “COLA is over 3%: FERS annuitants receive 1% less than the full COLA
      • “COLA is between 2% and 3%: FERS annuitants receive a 2% COLA
      • “COLA is less than 2%: FERS annuitants receive the full COLA
    • For 2025, based on those specifications, FERS retirees will receive a “diet” 2025 COLA of 2% for their retirement benefits beginning in January.
  • Tammy Flanagan, writing in Govexec, provides “a checklist to help [federal and postal employees and retirees] prioritize as [they] sort through your federal retirement and insurance benefits.”
  • Modern Healthcare reports,
    • “Healthcare companies pursuing mergers and acquisitions will be required to submit additional information about their proposals under a final rule approved by the Federal Trade Commission Thursday.
    • “The final rule amends the Hart-Scott-Rodino Act form, which had not been updated for 46 years. When the rule goes into effect, likely early next year, healthcare companies involved in M&A proposals must list acquisitions that occurred within the last five years, disclose private equity and minority stakeholders with decision-making authority and report supplier relationships shared by the merging parties to the FTC, among other requirements.”
  • Bloomberg informs us,
    • Johnson & Johnson did not wrongly manipulate bankruptcy rules when it filed an insolvency case in Texas and not its home state of New Jersey, a federal judge ruled, increasing the odds the consumer health giant can settle claims its baby powder gave women cancer.
    • Judge Christopher Lopez said Thursday he’ll keep a J&J subsidiary in his Houston courtroom, dismissing claims the company improperly skirted a federal appeals court for New Jersey that has twice stopped its bid to end thousands of talc injury lawsuits. 
    • “I want to assure everyone that they are going to get a fair trial in front of me,” Lopez said.
    • J&J is offering more than $8 billion to settle the litigation, a proposal the company has said is supported by roughly 83% of the women who voted on it. The settlement is being offered through a corporate shell J&J created to absorb the cancer claims and file bankruptcy, a controversial legal tactic known as the Texas Two Step.
  • The American Hospital Association News points out,
    • “The Health Resources and Services Administration Oct. 9 announced it will award nearly $19 million to 15 states for identifying and implementing maternal health strategies. The funds are part of HRSA’s Enhancing Maternal Health Initiative and will support State Maternal Health Innovation programs to help identify key drivers of maternal mortality in each state, develop strategies and implement new interventions to address those issues. The state programs have implemented a range of interventions to address maternal health challenges, which include early identification and treatment of hypertension to reduce preeclampsia and other risks, providing mobile simulation trainings to prepare health care providers for a range of adverse labor events, expanding access to trainings to rural and frontier hospitals that do not have a dedicated obstetrics department, and creating resources to improve first responders’ ability to respond to patients with substance use disorder during and after pregnancy.”

From the public health and medical research front,

  • The International Foundation of Employee Benefit Plans lets us know,
    • “Today is World Mental Health Day, a time to recognize the importance of mental health and to reaffirm commitments to improving mental health through education, awareness and advocacy. Many plan sponsors look toward mental health trends to stay informed on strategies for their workforce. Read on for key takeaways from a recent International Foundation webcast on 2024 mental health trends.
    • “The after-effects of the COVID-19 pandemic have resulted in increases in mental health needs across North America. In a 2024 survey from Gallup, U.S. adults reported how they thought mental health issues are handled compared to physical health issues: 38% reported “much worse,” 37% reported “somewhat worse,” and 15% reported “about the same.” The same survey indicates a perception that mental health conditions, including depression and anxiety, have increased over the past five years.
    • “According to a report from SunLife Canada, employers are seeing a rise in mental health care costs, including short- and long-term disability claims. The increased costs are sparking conversations about mental health treatment and leading employers to improve their employee benefits offerings to address mental health care.”
  • Per a U.S. Department of Agriculture press release,
    • BrucePac, a Durant, Okla. establishment, is recalling approximately 9,986,245 pounds of ready-to-eat (RTE) meat and poultry products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    • The ready-to-eat meat and poultry items were produced from June 19, 2024, to October 8, 2024. These products were shipped to other establishments and distributors nationwide then distributed to restaurants and institutions. Information regarding product labels and the list of products will be provided when available.
    • The products subject to recall bear establishment numbers “51205 or P-51205” inside or under the USDA mark of inspection.
  • The American Hospital Association News notes,
    • “The National Institutes of Health Oct. 10 released results of a study that found that infection from COVID-19 in the first wave of the pandemic appeared to significantly increase the risk of heart attack, stroke and death for up to three years for unvaccinated individuals. When infected, those individuals had double the risk for cardiovascular events, and people with severe cases had nearly four times the risk. The study also is the first to show that increased risk of heart attack and stroke in people with severe COVID-19 may have a genetic component involving blood type. It is unclear if the risk of cardiovascular disease is or may be persistent for people who have had severe COVID-19 from 2021 to the present, NIH said.”
  • The Wall Street Journal reports,
    • “Researchers are making progress toward vaccines that train healthy people’s immune systems to eliminate signs of cancer before it develops. 
    • “Vaccines are in early trials for people with inherited genetic mutations that put them at a greater risk. Other shots are designed to destroy precancerous lesions to stop full-blown disease. 
    • “It’s the future of cancer prevention,” says Dr. Ajay Bansal, a gastroenterologist at the University of Kansas Cancer Center.” * * *
    • “Many consider cancer vaccines to be a form of immunotherapy, a kind of treatment that has revolutionized cancer care by using the immune system to beat back cancer cells. Some of those therapies release the brakes on the immune system. Cancer vaccines, by contrast, are meant to boost the immune response and direct it where to go.
    • “Cancer cells and even pre-cancer cells know how to hide from the immune system,” says Dr. Neeha Zaidi, a medical oncologist at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. “It needs that help from a vaccine.”
  • The National Institutes of Health’s Director, writing her in blog, tells us,
    • “Developing a new drug from scratch can take a decade or more. But sometimes promising treatment options come from repurposing existing drugs for completely different medical conditions. I’m happy to share a new example of this: a cancer drug called pomalidomide that was found in a clinical trial to be safe and effective for treating a blood disorder called hereditary hemorrhagic telangiectasia (HHT).
    • “HHT is an inherited blood vessel disorder that can cause excessive or even life-threatening bleeding. The disease is rare, affecting about 1 in every 5,000 people worldwide, but because HHT is poorly understood and often misdiagnosed, its true incidence is likely greater. Most people with HHT experience recurrent severe nosebleeds, often in combination with mental health disorders such as depression and post-traumatic stress disorder, as well as other health conditions. HHT can also worsen with age and impact quality of life.
    • “However, recent findings from an NIH-supported clinical trial, reported in the New England Journal of Medicine, show that daily treatment with pomalidomide in people with HHT led to a significant reduction in nosebleed severity. Compared to trial participants taking a placebo, those taking pomalidomide needed fewer blood or iron transfusions and reported improvements in their quality of life. Because of these results, the trial was stopped months ahead of schedule, having found sufficient evidence that the treatment was safe and effective.”
  • Per MedPage Today,
    • “Medicare annual wellness visits were associated with a 21% increase in mild cognitive impairment diagnoses.
    • “Those with a wellness evaluation received a diagnosis 76 days earlier than others.
    • “Findings suggest the Medicare wellness visit policy may help identify cognitive impairment earlier.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “CVS Health is moving ahead with expansion plans for Oak Street Health, even as the company reportedly considers a restructuring in the coming months.
    • “CVS is conducting a strategic review, according to media reports citing people familiar with the matter and is weighing options for separating some of the company’s businesses, which include its retail pharmacy, insurance arm Aetna, pharmacy benefit manager CVS Caremark and primary care provider Oak Street.
    • “A spokesperson said CVS is sticking with its previously announced expansion plan for Oak Street but did not respond to questions about how many clinics it has opened this year. As of August, Oak Street had opened 16 clinics in 10 states since December, with aggressive plans to open another 38 or so clinics by the end of the year.”
  • Per Fierce Healthcare,
    • “Henry Ford Health has launched a population health subsidiary to help manage high-risk patients’ conditions and reduce costs tied to preventable hospitalizations or readmissions.
      Troy, Michigan-based Populance is described by the nonprofit health system as an extension of the “dozens” of case management programs it and its insurance subsidiary, Health Alliance Plan, have designed over the past two decades.
    • “Those programs—often designed with value-based care strategies in mind—will be supported at Populance with health analytics capabilities to help spot and address high-risk patients, the system said.
    • “Because we know this approach to population health management works—for our patients, our members and our physicians—we want to make these services available to other physicians, health systems and health plans to create healthier, more equitable outcomes in all the communities we serve,” Robin Damschroder, president of value-based enterprise and chief financial officer at Henry Ford Health, said in a release.”
  • RAND issued a paper titled “The Expense of Heath Care Explained: What Americans Need to Know.”
    • “Health care costs remain a critical concern for policymakers, providers, and patients alike. As voters head to the polls, the effectiveness of recent policies like the No Surprises Act and Medicare drug price negotiations are just beginning to be felt. Meanwhile, other major concerns loom, including how to deal with massive consolidation across the health care industry, and the complex dynamics of drug pricing, as well as burnout and other forces leading to shortages of health care providers.
    • “We asked three experts on the economics of health care to explain some of the financial and public policy forces at work. Cheryl Damberg holds the distinguished chair in Health Care Payment Policy and is director of the RAND Center of Excellence on Health System Performance. Andrew Mulcahy is a senior health economist at RAND who focuses on payments for health care services and prescription drugs. Erin Taylor is a senior policy researcher at RAND who is currently co-project director of the evaluation of the Medicare Part D Senior Savings Model.”
  • Per BioPharma Dive,
    • Within the pharmaceutical industry, a multibillion-dollar race is underway to top Novo Nordisk’s and Eli Lilly’s in-demand obesity drugs.
    • Dozens of companies, large and small, have set out to test experimental medicines they claim could be more potent, convenient or have fewer side effects than Novo’s Wegovy and Lilly’s Zepbound. But those two companies are already hard at work with successors of their own.
    • The next six months figure to be an important preview. Data are expected for a number of drugs that are already, or are shaping up to be, contenders in this high-stakes competition. The readouts will be closely watched, as they will set expectations for how the obesity drug market — currently a duopoly between Lilly and Novo — will look in the future.
  • The article tells you what to expect.
  • The Washington Post reports,
    • “Amazon plans to expand its drug delivery business as the company seeks more ways to insinuate itself into the daily lives of everyday Americans. The move would see the largest online retailer in the United States compete more directly with pharmacy retailers like CVS and Walgreens.
    • “Next year, Amazon customers in 20 cities — including Dallas, Minneapolis and Philadelphia — will be able to get Amazon Pharmacy medications delivered by the company, Amazon Pharmacy VP Hannah McClellan Richards said Wednesday. And a growing number of those deliveries will be completed within less than 24 hours, the company said.
    • “Richards said Amazon will double the number of cities with same-day delivery of medications next year, in part by building pharmacies in existing same-day delivery facilities that are “integrated directly into Amazon’s core logistics network.”

Midweek Update

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

From Washington, DC,

  • The New York Times reports,
    • “Healthcare facilities across the west coast of Florida, from clinics to nursing homes, are temporarily shutting their doors and evacuating patients in preparation for Hurricane Milton’s potentially devastating landfall.
    • “Mandatory evacuation orders in Pinellas County, which includes Clearwater and St. Petersburg, affect about 6,600 patients at six hospitals, 25 nursing homes and 44 assisted living facilities, according to the order. Scores of medical clinics and dialysis centers across the region have also closed, including dozens of outpatient facilities operated by the BayCare, a health care network.
    • “The region’s only Level 1 trauma center, Tampa General Hospital, has deployed a temporary flood barricade that officials hope will stave off the storm surge. Most of the hospitals in the region that are still open have suspended elective operations or have stopped accepting new patients.
    • “University of Florida Health, which operates about a dozen hospitals across the state, had enough food, water and fuel to keep its facilities operating for 96 hours, according to Peyton Wesner, a spokesman.”
  • and
    • “U.S. officials approved airlifts of IV fluids from overseas manufacturing plants on Wednesday to ease shortages caused by Hurricane Helene that have forced hospitals to begin postponing surgeries as a way to ration supplies for the most fragile patients.
    • “The current shortage occurred when flooding coursed through western North Carolina and damaged a Baxter plant, which is now closed for cleaning. The plant makes about 60 percent of the United States’ supply of fluids used in IVs, for in-home dialysis and for people who rely on IV nutrition. They include premature babies in intensive care and patients who rely on tube feeding to survive.
    • “The situation could become even more dire now that Hurricane Milton is hitting Florida. On Tuesday, workers at B. Braun, makers of a fourth of the nation’s IV fluids, loaded trucks at the company’s plant in Daytona Beach with the medical bags and drove them north through the night to what they hoped would be a safer location.
    • “The Baxter plant, in Marion, N.C., and the B. Braun site in Daytona Beach manufacture about 85 percent of the nation’s supply of IV fluids. Experts on shortages have long pointed out the risk of such over-concentration of critical supplies, citing exposure to disasters like those now at hand. Even before the latest storm, supplies were tight and reflected a longstanding problem of how few companies are willing to produce crucial but low-cost and low-profit medical products.”
  • Here’s a link to an HHS Secretary letter to healthcare leaders about the IV fluid shortage, and Beckers Payer Issues offers five notes on insurer response to Hurricane Milton.
  • Kevin Moss, writing in Govexec, takes a closer look at 2025 FEHB premiums.
  • CMS has issued a memorandum with payment parameters guidance for the 2026 plan year
    • The 2025 maximum limit on cost sharing for FEHB and other group plans is $10.150 for self only coverage and $20,300 for other than self only coverage. These limits represent approximately a 10.3% increase over the 2025 maximum limits of $9,200 for self only coverage and $18,400 for other than self only coverage.
  • “The International Foundation of Employee Benefit Plans shares links to the final 1094-B, 1095-B, 1094-C, and 1095-C forms [and instructions] that employers, plan sponsors and group health insurers will use to report 2024 health coverage to plan members, and the IRS as required by the Affordable Care Act (ACA).” 
  • STAT News tells us,
    • “A new report from congressional budget experts this week estimated that it would cost Medicare an additional $35 billion over nine years if the program began covering GLP-1 drugs for obesity. But the report also noted that half of seniors who would qualify for obesity coverage already have access to the drugs for other conditions.”
  • The American Hospital Association News notes,
    • “The Centers for Medicare & Medicaid Services Oct. 9 released a request for information and a sample list of prescription drugs it intends to include under a proposed Medicare $2 Drug List Model. Under the model, people enrolled in a Part D plan would have access to these drugs for a low, fixed copayment no higher than $2 for a month’s supply per drug. The model would provide individuals more certainty about out-of-pocket costs for these generic covered drugs that would target common conditions such as high cholesterol and high blood pressure. The Center for Medicare and Medicaid Innovation’s model aims to test whether a simplified approach to offering low-cost, clinically important generic drugs can improve medication adherence, lead to better health outcomes and improve satisfaction with the Part D prescription drug benefit among Medicare beneficiaries and prescribers. It is also aligned with Executive Order 14087, “Lowering Prescription Drug Costs for Americans,” which directed the creation of new payment models to lower drug costs and promote access. Comments are due Dec. 9 through a CMS survey.”
  • KFF provides us with “A Current [Detailed] Snapshot of the Medicare Part D Prescription Drug Benefit.”
  • The Wall Street Journal reports,
    • “CVS Health filed a motion seeking to disqualify top Federal Trade Commission officials from participating in a case regarding some of its businesses over alleged bias against pharmacy benefit managers.
    • “The healthcare company said Chair Lina Khan, Commissioner Rebecca Kelly Slaughter and Commissioner Alvaro Bedoya through public statements show they have prejudged the matter at hand and that their participation would violate the due process rights of respondents Caremark Rx and Zinc Health Services.
    • “CVS specified that past statements made false assertions that are critical to the merits of the case, including that pharmacy benefit managers “control” drug pricing and patient access to drugs including insulin.
    • “Cigna Group, on behalf of Express Scripts and other of its businesses, also filed a motion seeking to disqualify Khan, Slaughter and Bedoya.
    • “UnitedHealth Group, who reportedly filed a similar motion, didn’t immediately respond to a request for comment.”

From the public health and medical research front,

  • STAT News points out,
    • “A trio of scientists who opened new doors in our understanding of the structure of proteins — the fundamental building blocks of biology — and even came up with ways to create new proteins won the Nobel Prize in chemistry Wednesday.
    • “The prize went to David Baker of the University of Washington, and to Demis Hassabis and John Jumper, who work at Google DeepMind in London. Baker will receive half the 11 million Swedish kronor (just over $1 million) prize, while Hassabis and Jumper will split the other half.” * * *
    • “Baker said he was sleeping when he received the Nobel call early Wednesday morning, as is often the case for laureates in the U.S. When he was told he had won the prize, his wife started yelling, drowning out the person on the phone. He had to go to another room so he could hear the rest of the call, he said. 
    • “Asked by one journalist to pick his favorite protein, Baker demurred, saying he didn’t want to identify just one. But he did highlight one that he and his colleagues had crafted that could potentially block the coronavirus behind Covid-19 from infecting cells, hinting at one of the applications of his discoveries that researchers are now pursuing. 
    • “I’ve been very excited about the idea of a nasal spray of little designed proteins that would protect against all possible pandemic viruses,” he said.”
  • Kudos to the recipients.
  • The American Medical Association tells us what doctors wish their patients knew about microplastics.
  • The National Cancer Institute shares its Cancer Information Highlights about “Breast Cancer | Jaw Necrosis | Leiomyosarcoma.”
  • Per National Institutes of Health press release,
    • “The National Institutes of Health has launched a nationwide consortium to address the dramatic rise in youth diagnosed with type 2 diabetes over the past two decades, a trend that is expected to continue. The effort aims to advance understanding of the biologic, social, and environmental drivers of youth-onset type 2 diabetes, with the goals of determining which children are at highest risk for developing the disease and how to better prevent, screen for, and manage type 2 diabetes in young people.
    • “Our children who are overweight or have obesity are at risk, but we don’t know how best to identify the children who will progress to type 2 diabetes,” said Rose Gubitosi-Klug, M.D., Ph.D., study lead, and chief of pediatric endocrinology at Case Western Reserve University/Rainbow Babies and Children’s Hospital, Cleveland. “This study will bring us closer to our goal of prevention of type 2 diabetes in future generations of youth.” * * *
    • “For more information about the study, known as DISCOVERY of Risk Factors for Type 2 Diabetes in Youth, please visit discovery.bsc.gwu.edu.”

From the U.S. healthcare business front,

  • The American Hospital Association News lets us know,
    • “The average annual premium for employer-sponsored family health coverage rose 7% in 2024 to $25,572, according to the latest KFF annual survey. It is the second consecutive year with a 7% increase. For workers who have an annual deductible for single coverage, the 2024 average is $1,787, similar to last year’s $1,735 and up 8% from 2019. The survey found that the amount workers’ pay toward annual premiums has increased less than 5% since 2019, which may be due to a tight labor market.”
  • Per Beckers Hospital CFO Report,
    • “Chicago-based CommonSpirit is “investing significantly in high-growth markets,” such as Arizona and Colorado, to ensure the long-term sustainability of the health system, CFO Dan Morissette said during the company’s investor call on Oct. 4.
    • “Last year, Centennial, Colo.-based Centura Health folded into CommonSpirit, which manages 20 hospitals and more than 240 care sites in Colorado, Kansas and Utah that were previously managed by Centura. 
    • “The news came shortly after CommonSpirit and Altamonte Springs, Fla.-based AdventHealth said they would end their Centura Health joint venture after 27 years, with each system directly managing their respective care sites in Kansas and Colorado. 
    • “Much of our focus in this market is on transition alignment and ambulatory care sites, as well as future inpatient growth to meet the rapidly expanding demand,” Mr. Morissette said. “We also announced a partnership with Kaiser in this market, which is an important new collaboration for us.Intentional capital deployment means taking a system-level approach to reviewing and 
    • “CommonSpirit is also diversifying its service line in these high-growth markets. Areas of focus include behavioral health, cancer care and outpatient care.”
  • Per Fierce Pharma,
    • “GSK has agreed to pay up to $2.2 billion to resolve approximately 80,000 lawsuits brought by users of Zantac who claimed the heartburn drug caused their cancer.
    • “The agreement frees the British pharma giant from litigating 93% of the state court cases it faced in the U.S., most of which had been consolidated in Delaware. The settlement was reached with 10 plaintiff firms with the agreement that GSK does not admit liability, the company said.
    • “With the deal, lawyers representing the plaintiffs are unanimously recommending that clients accept terms of the settlement, which is expected to be complete by the end of the first half of 2025, GSK said.
    • “The agreement is in line with a similar settlement Sanofi reportedly made earlier this year. The French pharma consented to pay $100 million to resolve roughly 4,000 Zantac claims, Bloomberg reported in April. That deal paid plaintiffs roughly $25,000 each. The GSK settlement comes to approximately $27,500 per claimant.
    • ‘In May of this year, Pfizer also settled approximately 10,000 Zantac lawsuits for an undisclosed figure. Pfizer had the rights to sell the antacid from 1998 to 2006.
    • “In addition to the $2.2 billion deal, GSK also said on Wednesday that it will pay $70 million to resolve a qui tam complaint filed by Connecticut-based laboratory Valisure, which first raised alarm bells about Zantac’s risks in 2019 during routine batch testing.”
  • Per MedTech Dive,
    • “The number of medical devices with artificial intelligence technology has risen sharply in the past decade. 
    • “The Food and Drug Administration has authorized 950 AI or machine learning-enabled devices as of Aug. 7, 2024, according to the agency’s database. While the FDA authorized the first AI-enabled device in 1995, the number of submissions has spiked in recent years.
    • “In 2015, the FDA authorized six AI medical devices. In 2023, the agency authorized 221 devices, according to data reviewed by MedTech Dive.
    • “The trend has been driven by more connected devices, more investment into AI and machine learning and growing familiarity with how software is regulated as a medical device, experts said in interviews.
    • “We’re definitely seeing huge increases in investment. There’s no doubt about that,” said Jennifer Goldsack, CEO of the Digital Medicine Society, an industry group for digital health.”

Tuesday Tidbits

David Ermer–ACA, CDC, FDA, Federal employment benefits, Medical / Rx research, NIH, OPM, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Yesterday, the Supreme Court invited the Solicitor General to submit a brief expressing her views on the 10th Circuit’s decision in PCMA v. Mulready which is favorable to ERISA and Medicare preemption of state PBM reform laws.
  • The Solicitor General typically submits a brief favoring Supreme Court review no later than December so that the Court can hear the case in its current term. If the Solicitor General opposes Supreme Court review, her brief likely will be submitted next April.
  • The FEHBlog hopes that the Solicitor General files an April 2025 brief.
  • Also yesterday, the Defense Department announced a one-year pilot program to provide no-cost supplemental health support services to DoD civilian employees serving in Japan after a yearlong effort to identify and address concerns regarding access to medical care.
    • “This pilot is called the Pilot Health Insurance Enhancement for DoD Civilian Employees in Japan and will assist [11,000] eligible civilian employees with health care navigation and upfront costs associated with accessing Japan’s healthcare system.
    • “To be eligible, the employee must be enrolled in a participating health plan through the Federal Employees Health Benefits (FEHB) program. The enrollment window for eligible employees will be the Federal Benefits Open Season, which runs this year Nov. 11 through Dec. 9. Federal Benefits Open Season allows federal civilians to enroll in or change health care options.
    • “The services provided under this pilot will begin Jan. 1, 2025, when participants can use the services and access support through a call center. The call center will be open 24/7 and staffed with bilingual service representatives who will assist callers with identifying their needs, make appointments with provider offices, and issue payment guarantees up front. Dependents are not eligible for services during the pilot, which runs through Sept. 29, 2025. * * *
    • “The Office of the Assistant Secretary of Defense for Health Affairs will oversee the pilot program and has awarded a $4.2 million contract to International SOS Government Services Inc., which is also the prime contractor for the TRICARE Overseas Program. The contract for this pilot is being funded by the military departments, defense agencies and DoD field activities that have civilian employees working in Japan.
    • “Active-duty service members and TRICARE Prime beneficiaries have prioritized access to health care in military hospitals and clinics based on current federal law and DoD policy. DoD civilians who are not TRICARE beneficiaries may use military health facilities on a space-available basis. [This unfortunate 2023 policy change led to this pilot.]
    • “Agreements with FEHB insurance carriers who currently provide coverage for DoD civilian employees in Japan will be established to provide direct billing agreements. Non-appropriated Fund (NAF) employees are eligible for this program if enrolled in an Aetna International plan.”
  • The FEHBlog finds it odd that the DOD pilot does not cover eligible family members.
  • Health Affairs Forefront provides even more details on the lengthy proposed 2026 Notice of Benefit and Payment Parameters for the ACA marketplace released last Friday.
  • Federal News Network tells us,
    • “After making improvements for two months, the Office of Personnel Management retirement backlog saw a decline in claims received and processed claims for the month of September.
    • “OPM received 5,618 claims in September, 1,465 less than the month of August’s claims received. OPM processed 6,302 claims in September, 1,400 less than in August.”
    • That appears to be a wash to the FEHBlog.

From the public health and medical research front,

  • American Hospital News informs us,
    • “The Centers for Disease Control and Prevention last week confirmed the first two human cases of H5 bird flu in California. The individuals were workers who had contact with infected dairy cows, CDC said. There have been 16 total human cases of H5 bird flu reported in humans across the country this year, with six being linked to exposure to sick or infected dairy cows, nine with exposure to infected poultry, and one case in Missouri with an origin that has yet to be determined. The CDC’s risk assessment of a bird flu outbreak for the general public remains low.”
  • Per BioPharma Dive,
    • “Vaccine maker GSK unveiled new data Tuesday showing its respiratory syncytial virus vaccine Arexvy protected older adults over three seasons against disease caused by infection.
    • “Across the entire time period, one dose of Arexvy was 63% effective against RSV broadly, and 67% effective against severe disease, GSK said. However, the shot’s efficacy waned, falling to an estimated 48% in the third season alone.
    • “Currently, the Centers for Disease Control and Prevention doesn’t recommend a second RSV vaccine dose. While GSK described the three-season data as evidence of the shot’s “significant health impact,” it said that “over time, revaccination is expected to be required to maintain an optimal level of protection.”
  • CNN reports,
    • “A new study found that having your arm in the wrong position during blood pressure checks — either at home or the doctor’s office — can result in readings “markedly higher” than when your arm is in the recommended position: appropriately supported on a table with the middle of the cuff positioned at heart level.
    • “This suggests that not consistently having your arm positioned and supported appropriately during a blood pressure reading might result in a misdiagnosis of high blood pressure, which some experts worry could possibly lead to unnecessary treatment.
    • “The study, published Monday in the journal JAMA Internal Medicine, found that having your arm resting in the lap during a blood pressure reading can lead to an overestimated systolic blood pressure measurement by 3.9 mm Hg and overestimated diastolic reading by 4 mm Hg. And having your arm hang by your side can lead to an overestimated systolic reading by 6.5 mm Hg and overestimated diastolic reading by 4.4 mm Hg.”
  • Per Healio,
    • “A blood test for men at the time of a metastatic prostate cancer diagnosis may predict treatment response and survival, according to study results.
    • “The test could help oncologists decide which patients should receive standard treatment and who might derive more benefit from a clinical trial, researchers concluded.”
  • The Washington Post lets us know,
    • “Children should spend up to two hours a day outside to reduce their risk of myopia, or nearsightedness, according to a new consensus report from the National Academies of Sciences, Engineering and Medicine. At least one of those hours should take place during the school day, the report says.
    • “Myopia is a condition in which distant objects are blurry but close-up objects look clear. The National Academies report cites research indicating a significant rise in myopia worldwide.”
  • The National Institutes of Health posted the latest issue of “Women’s Health In Focus at NIH, Volume 7, Issue 3, 2024.” This is a quarterly publication of NIH’s Office of Research on Women’s Health.
  • The International Foundation of Employee Benefit Plans offers flu season advice to employers.

From the U.S. healthcare business front,

  • The KFF-Peterson Health Tracker shares a “chart collection explores how health spending is expected to grow in coming years, based on National Health Expenditure (NHE) projections from federal actuaries. A related chart collection explores how U.S. health spending has changed over time using historical data, and an interactive tool allows users to explore health spending changes over time.”
  • Modern Healthcare reports,
    • “Four large nonprofit health systems created a new company to use as a testing ground for boosting access to drugs, improved care coordination for Medicare Advantage patients and streamlined billing processes.
    • “Baylor Scott & White Health, Memorial Hermann Health System, Novant Health and Providence are the founding members of Longitude Health. Each health system has made an undisclosed financial commitment to fund Longitude, which is a Delaware-based holding company owned and managed by its founders.
    • “The health system-led, for-profit entity plans to form three operating companies that will essentially act as startups on pharmaceutical development, care coordination and billing. Chief executive officers of the participating systems make up the Longitude board, along with Longitude CEO Paul Mango, former chief of staff at the Centers for Medicare and Medicaid Services.
    • “Executives hope to create additional operating companies and attract more health systems and investors over the next year.”
  • Beckers Hospital Review adds, “The U.S. spent $99 billion on both oral and clinician-administered cancer therapies in 2023, according to a report published in April by analytics firm IQVIA. As cancer drug prices continue to increase, spending is projected to grow.”
  • Per Fierce Pharma,
    • “As the eastern U.S. braces for another storm in the form of Hurricane Milton, at least one major drugmaker is stepping up to support Florida locals and preserve access to critical medical supplies and drugs.
    • “Pfizer—which opened a global hub in Tampa, Florida, in 2021—is setting out to bolster emergency services, pool donations and ease medical supply needs as Milton touches down this week, the company’s CEO, Albert Bourla, Ph.D., said in a post on X (formerly Twitter) Tuesday.
    • “Like many people, I have watched with a heavy heart as the scale of the damage caused by Hurricane Helene has become fully evident,” the chief executive said. “Now it seems Hurricane Milton is heading toward the Tampa area, where we have a major Pfizer facility.”
    • “In light of the impending natural disaster, Bourla said Pfizer is pledging all it can to support the community during this trying time.”
  • Per MedTech Dive,
    • “Baxter said Monday it has made progress restoring a North Carolina manufacturing plant damaged by Hurricane Helene. 
    • “Rain and storm surge from Hurricane Helene flooded the plant and damaged access bridges. So far, Baxter has not identified any structural damage to the facility. The Marion, North Carolina, site is the company’s largest manufacturing facility and produces dialysis solutions and IV fluids.
    • “Baxter is resuming shipments of dialysis products to hospitals and patients after a temporary hold last week.”
  • and
    • “Mercury Medical has recalled 1,300 emergency breathing support devices in response to a problem that can affect ventilation of the patient.
    • “The Food and Drug Administration, which published an alert about the problem Monday, categorized the action as a Class I recall. Mercury asked customers to stop the use and distribution of the affected devices.
    • “No reported injuries or deaths have been associated with the issue, but the FDA said affected products could cause serious adverse health consequences.”
  • Beckers Hospital Review points out,
    • “A group representing companies that produce copycat versions of Eli Lilly weight loss medications has filed a lawsuit against the FDA following the agency’s recent decision to remove the drugs from its shortage list, Bloomberg reported Oct. 7. 
    • “The Outsourcing Facilities Association, along with compounding pharmacy FarmaKeio Superior Custom Compounding, alleged the FDA acted arbitrarily and failed to provide prior notice regarding its decision. 
    • “The plaintiffs asserted that the shortage of Lilly’s drugs is not truly over and argued that the FDA’s action limits patient access to essential medications. The lawsuit seeks to overturn the FDA’s removal of Lilly’s weight loss drugs from the shortage list. 
    • “With the FDA announcement, many patients who relied on compounded versions of the medications now face the choice of switching to higher priced brand-name medications or seeking alternatives from Novo Nordisk.” 
  • Per SHRM, Mercer Consulting predicts
    • “Employers may be cautious about pay due to economic concerns, but they are planning to stay consistent with salaries next year—at least for now.
    • “On average, U.S. employers are budgeting for 3.3% merit increases and 3.6% increases for their total salary budgets for nonunionized employees, according to new data from consulting firm Mercer, which surveyed more than 1,100 employers to gauge what pay will look like in 2025. These numbers are the same as the actual pay increases that employers delivered in 2024.
    • “Mercer’s analysis also found that, in addition to remaining consistent with salary increases, employers are planning to promote just under 10% of their employees in 2025. For companies with a separate promotion budget, the average promotion increase budget for 2025 is 1%, down slightly from 1.1% in 2024.
    • “There are variations in compensation projections across industries, Mercer found. For example, technology and life sciences reported above-average compensation budgets, with merit and total increase budgets at 3.5% and 3.9%, respectively. On the other end of the spectrum, retail and wholesale reported merit and total increase budgets of 3.1% and 3.3%, respectively.”

Thursday Miscellany

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “Eli Lilly has finally made enough supply of its popular medicine tirzepatide to meet soaring demand, which should help the company widen its share of the booming weight-loss drug market.
    • “The Food and Drug Administration said late Wednesday that Lilly had resolved the shortage. It had started in 2022, just months after the drug was introduced with the brand Mounjaro for diabetes. Tirzepatide was approved as Zepbound in late 2023 as a weight-loss treatment.
    • ‘The milestone means that compounding pharmacies that make knockoff versions of tirzepatide will likely face new restrictions on what they can produce.
    • “The compounding pharmacies had legal cover to sell knockoff tirzepatide as long as it was on the FDA shortage list, and many patients turned to these products as a cheaper alternative. Yet in announcing the end of the shortage, the FDA said federal law bars compounders from making copies of drugs that aren’t on the shortage list, though they may make certain amounts.
    • “This essentially precludes compounded tirzepatide from being produced commercially,” BMO Capital Markets analysts said.” * * *
    • “Lilly’s rival, Novo Nordisk, also has been expanding its production capacity to resolve shortages of a similar drug, semaglutide, sold as Ozempic for diabetes and Wegovy for weight loss. The lowest dose of Wegovy is currently in shortage, while higher Wegovy doses and all Ozempic doses are available, according to the FDA shortage list.”

  • Per Healthcare Dive,
    • “A bipartisan group of two dozen lawmakers is urging the Biden administration to extend telehealth prescribing flexibilities for opioid use disorder treatment. 
    • “The representatives, led by Reps. Annie Kuster, D-N.H., and Carol Miller, R-W.Va., argued flexibilities allowing telehealth prescriptions of buprenorphine without an in-person visit has increased access to treatment and reduced overdoses.
    • “But those flexibilities are set to expire at the end of the year. Lawmakers also raised concerns that the Drug Enforcement Administration could propose more stringent requirements for telehealth prescriptions of buprenorphine, a medication that be used to treat opioid use disorder, limiting its use just as overdose deaths have begun to decline.” 
  • STAT News reports,
    • “A key aspect of the Democrat-passed law to lower drug prices is significantly more expensive to the government than expected, according to nonpartisan budget experts in Congress.
    • “The redesign of the Medicare Part D drug benefit will cost $10 billion to $20 billion more next year than the Congressional Budget Office initially projected. That office estimates that a separate recently announced program to pay insurers to lower drug premiums will cost $5 billion.”
  • Per Fierce Healthcare,
    • The Biden administration could stand to take a firmer hand on hospital price transparency, especially when it is unclear whether the price data being published are even accurate, the Government Accountability Office (GAO) wrote in a Wednesday report.
      The Centers for Medicare & Medicaid Services (CMS) has required hospitals to post the prices for numerous services annually and this past summer raised the bar by ensuring hospitals were doing so using a standardized file format.
    • Numerous reports from stakeholders criticized hospitals’ compliance along the way, with hospitals themselves often saying that the requirements were burdensome and often too vague.
    • On instruction from Congress, the GAO conducted a review of the requirements, the CMS’ enforcement and whether the agency’s policy was successfully serving patients, payers and researchers.
    • The GAO interviewed 16 stakeholder groups—representing those three groups—who described difficulties making effective comparisons and compiling the data for large-scale use. These hurdles were tied to inconsistent file formats, pricing complexities that came across poorly in the machine-readable format and what they perceived to be incomplete and inaccurate data sets.
    • “While the use of hospital price transparency data has been limited so far, many stakeholders we interviewed noted that they expect use to increase over time if the data usability challenges are overcome or addressed,” the GAO wrote in the report. “Further, some stakeholders also noted that it will take health plans and employers time to figure out how to effectively use the pricing data as part of their price negotiations and their efforts to develop networks of health care providers.”
  • The GAO also issued a healthcare capsule report on treatment for drug misuse.
  • Per an HHS press release,
    • “As part of the Biden-Harris administration’s efforts to ensure Americans access to affordable medicines and strengthen American medical supply chains, the Administration for Strategic Preparedness and Response (ASPR) today announced a $12.3 million agreement with California-based Amyris to expand U.S.-based manufacturing of key starting materials and active pharmaceutical ingredients needed to make essential medicines.” 
  • Tammy Flanagan, writing in Govexec, discusses end of year retirement planning for federal couples.
  • Per an OPM press release,
    • “The U.S. Office of Personnel Management (OPM) has authorized the use of an emergency leave transfer program (ELTP) for federal employees and their families adversely impacted by Tropical Cyclone, Tropical Storm, and Hurricane Helene.    
    • “After coordinating with federal agencies to assess the impact on employees by Tropical Cyclone, Tropical Storm, and Hurricane Helene and its aftermath, OPM, in consultation with the Office of Management and Budget (OMB), has determined that the establishment of an ELTP is warranted. The establishment of an ELTP permits employees in the executive and judicial branches, or agency leave banks established under 5 U.S.C. 6363 to donate unused leave for transfer to employees within their agency or at other agencies who are severely adversely affected or have family members who are severely adversely affected by a major disaster or emergency as declared by the President and who need additional time off from work without having to use their own paid leave. This ELTP will assist federal employees in the declared disaster areas in Alabama, Florida, Georgia, North Carolina, South Carolina, Tennessee, and Virginia. Furthermore, if President Biden approves other disaster declarations because of Helene, federal employees in those areas will also become eligible for ELTP donations.”    
  • Federal News Network tells us,
    • “The Merit Systems Protection Board has brought a historic backlog of federal employee adverse action cases down to nearly zero.
    • “By the end of September, MSPB reported that it had issued decisions on 94% of the thousands of federal employee appeal cases that had been sitting stagnant during the record five-year period without a quorum. Between 2017 and 2022, vacant board seats left the agency unable to issue case decisions, and thousands of federal employees without answers on their pending appeals.
    • “As an agency, MSPB aims to protect federal employees against prohibited personnel practices, like whistleblower retaliation, by adjudicating adverse action appeals from employees. But during more than five years without a quorum — which requires at least two of the three board seats to be occupied — MSPB amassed nearly 3,800 pending cases from federal employees looking to appeal a decision on an adverse action.
    • “The process of shrinking the significant case backlog has so far taken about 2.5 years for the current MSPB members. During fiscal 2025, the board expects to fully eliminate the remaining pending cases that built up during the lack of quorum. The agency will likely take the “inherited inventory” down to zero by the end of December, according to an MSPB spokesperson.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The U.S.’s largest maker of intravenous fluids will slash shipments to hospitals after Hurricane Helene took down one of its manufacturing plants in North Carolina. 
    • “Baxter sent letters to hospitals telling them that future shipments of IV fluids would be about 40% of what they normally receive after the storm flooded its facility in Marion, N.C., Dr. Paul Biddinger, chief preparedness and continuity officer at Mass General Brigham in Boston said during a conference call Thursday. 
    • “Mass General Brigham, a prestigious hospital system, said it is continuing to treat patients normally, but is conserving its fluid supplies. This includes switching to oral hydration—Gatorade or water—for patients who are healthy enough for it, and not discarding partially used IV fluid bags when patients are moved to a different part of the hospital, Biddinger said. The organization uses hundreds of thousands of liters of IV fluids each month, and a majority of patients admitted to a hospital receive fluids at some point, Biddinger said.
    • “Right now we’re continuing all of our clinical care as we normally do,” Biddinger said. “Our intent is to preserve clinical care in the face of this shortage as long as we possibly can.” 
  • Beckers Hospital Review identifies the 73 drugs and intravenous fluids made at the flooded Baxter facility.
  • The Washington Post explains “Why fears of human-to-human bird flu spread in Missouri are overblown. Hospital workers reported respiratory symptoms after encountering a Missouri patient with H5N1 who had not been exposed to farm animals. Officials say bird flu transmission is unlikely.”
  • The NIH Director, writing in her blog, tells us,
    • “In recent years, medical researchers have been looking for ways to use artificial intelligence (AI) technology for diagnosing cancer. So far, most AI models have been developed to perform specific tasks in cancer diagnosis, such as detecting cancer presence or predicting a tumor’s genetic profile in certain cancer types. But what if an AI system could be more flexible, like a large language model such as ChatGPT, performing a variety of diagnostic tasks across multiple cancer types?
    • “As reported in the journal Nature, researchers have developed an AI system that can perform a wide range of cancer evaluation tasks and outperforms current AI methods in tasks like cancer cell detection and tumor origin identification. It was tested on 19 cancer types, leading the researchers to refer to it as “ChatGPT-like” in its flexibility. According to the research team, whose work is supported in part by NIH, this is also the first AI model based on analyzing slide images to not only accurately predict if a cancer is likely to respond to treatment, but also to validate these predictions across multiple patient groups around the world.” * * *
    • “This is all good news, but there’s much more work ahead before an AI model like this could be used in the clinic. Next steps for the researchers include training the model on images of tissues from rare cancers, as well as from pre-cancerous and non-cancerous conditions. With continued development and validation, the researchers aim to enable the system to identify cancers most likely to benefit from targeted or experimental therapies in hopes of improving outcomes for more people with cancer in diverse clinical settings around the world.”
  • Healio informs us,
    • “The addition of HPV vaccination into routine postpartum care may increase vaccination rates, which can reduce patient costs, prevent HPV-related cancers and vaccinate vulnerable populations, researchers reported in Obstetrics & Gynecology. 
    • “The postpartum period has been identified as a missed opportunity for HPV vaccination counseling and administration,” Sara E. Brenner, MD, MPH, third-year resident in the department of gynecology and obstetrics at Emory University School of Medicine, and colleagues wrote. “Many vaccinations are already given routinely in the postpartum period such as the Tdap and the measles-mumps-rubella vaccines. These are often incorporated into perinatal workflows so that patients are routinely educated on their options for vaccination during their prenatal visits and postpartum patients can receive them before leaving the hospital.”
  • The American Hospital Association News informs us about “refreshed webpages dedicated to maternal and child health. The redesigned platform offers three distinct subpages focused on Better Health for Mothers and Babies, child and adolescent health, and advocacy and policy. Hospitals and health systems are encouraged to explore the tools and resources, such as case studies, podcasts, infographics and action plans to drive their own improvement in maternal and child health.”
  • Per STAT News,
    • “Apple Watch may help keep people with Parkinson’s disease out of the hospital. That’s according to early data from a Kaiser Permanente pilot program.
    • “Since late 2023, Kaiser Permanente has been giving some of its Parkinson’s patients in California an Apple Watch app called StrivePD, developed by Rune Labs. The app uses the onboard sensors in the device to track tremors associated with the disease; dyskinesia, a side effect of medication; activity; sleep; and falls. Using Rune’s software, people can also track medication intake and other data.” * * *
    • “Kaiser and Rune presented data from 138 patients enrolled in the program at the International Congress of Parkinson’s Disease and Movement Disorders in late September. In a limited run, the program reduced patient visits to the emergency department by 42% and reduced visits to movement disorder specialists by 18%. Three-quarters of people in the program reported that they found StrivePD helpful for staying on top of medications.
    • “It’s important to note that the data is only a snapshot from the first 100 days that people are in the program. It is not a randomized control that researchers would want to see to establish the benefits of a treatment program. And the data has not been published in a peer-reviewed publication.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports this evening,
    • “U.S. dockworkers agreed to return to work after port operators sweetened their contract offer, ending a three-day strike that threatened to disrupt the American economy.
    • “The breakthrough Thursday came after port employers offered a 62% increase in wages over six years, according to people familiar with the matter.
    • “The agreement ends a strike that had closed container ports from Maine to Texas and threatened to disrupt everything from the supply of bananas in supermarkets to the flow of cars through America’s factories.”
  • Per Fierce Healthcare,
    • “Another significant legal headache related to star ratings is on the table of the federal government just days before open enrollment begins.
    • “UnitedHealthcare companies in various states are suing the Centers for Medicare & Medicaid Services (CMS) for decreasing the insurer’s star ratings unfairly. They are looking for an injunction and corrected ratings before Oct. 15.
    • “The plaintiffs allege one metric, call center customer service performance, was downgraded based on an “arbitrary and capricious assessment” of one phone call [by a CMS test caller] that lasted eight minutes. It caused the insurer to earn a four-star rating on the call center measure instead of a five-star rating.”
    • UnitedHealthcare said the star ratings downgrade would “misinform millions of current and potential customers” from choosing their plans, the insurer said in the lawsuit.
  • Per BioPharma Dive,
    • “Eli Lilly on Wednesday announced plans to spend $4.5 billion on a new facility that will use advancements in technology for research and manufacturing.
    • “Dubbed the Lilly Medicine Foundry, the new site will be located in the “LEAP Research and Innovation District” in Lebanon, Indiana. The latest infusion of cash brings Lilly’s investment in the LEAP district to more than $13 billion.
    • “The facility will allow Lilly to produce medicines for clinical trials while also researching new methods of manufacturing, the company said. Technologies developed at the foundry can then be deployed at other production sites around the world.”