Tuesday Report

SDOH

Tuesday Report

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

From Washington, DC,

  • Last week, the President issued another Executive Order on deregulation. The EO begins
    • “Deregulation is a critical priority for my Administration.  We will foster prosperity by freeing Americans from the heavy burden of Federal regulations accumulated over decades.”
  • The American Hospital Association (AHA) News tells us,
    • “The Department of Health and Human Services May 13 announced a 60-day public comment period opened for stakeholders regarding its request for information to remove outdated or unnecessary regulations. The request stems from an executive order issued in January requiring HHS to implement a “10-to-1” rule, eliminating at least 10 existing regulations for every new regulation introduced. Comments on the RFI can be submitted at regulations.gov/deregulation.”
  • When will OPM make a similar deregulation announcement?
  • The Congressional Research Service released a report on the House Oversight and Government Reform Committee’s budget reconciliation measures. The Congressional Budget Office posted its own report on those recommendations.
    • “In CBO’s estimation, the reconciliation recommendations of the House Committee on Oversight and Government Reform would, on net, decrease deficits by $51.0 billion over the 2025‑2034 period. The estimated budgetary effects of the legislation are shown in Table 1. The costs of the legislation mainly fall within budget functions 550 (health), 600 (income security), 800 (general government), and 950 (undistributed offsetting receipts).”
  • Modern Healthcare reports,
    • “Doctors that treat Medicare beneficiaries would receive a pay boost under the sweeping tax-and-spending cuts legislation House Republicans unveiled Monday.
    • “Medicare reimbursements to physicians declined 2.9% this year, provoking outcries from medical societies that complain doctor pay has failed to keep up with cost increases. The GOP measure would raise rates next year and remake the Medicare Physician Fee Schedule to link future updates to the Medicare Economic Index, which generally rises faster than overall inflation.
    • “In 2026, the legislation would hike Medicare physician payments by an estimated 2.25%. That projection is based on how the bill would modify the “conversion factor” that determines Medicare fees for physician services. Next year, that formula would be boosted by 75% of growth in the Medicare Economic Index. In later years, it would fall to 10% of medical inflation.
    • “The physician pay increase comes with a downside for some providers, however. While the measure would raise rates, it would curtail financial incentives under alternative payment models.”
  • Bloomberg Law reports,
    • “House Republicans revived a set of policies that would change how prescription drug middlemen do business, as President Donald Trump again denounced the industry, sending shares of some of the companies down Monday.
    • “The budget proposal from the House Committee on Energy and Commerce includes a set of reforms that Congress considered last year but ultimately didn’t pass. It would remove one method that the companies, which negotiate with drugmakers and pharmacies on behalf of employers, health insurers and government programs, use to boost profits.
    • “The revival of the modest reforms in the House budget plan adds to pressure on the companies, which are already facing intense scrutiny in Washington. Trump complained about the companies known as pharmacy benefit managers during a press conference Monday touting his executive order intended to help lower the prices Americans pay for drugs.”
  • The Senate Judiciary Committee held a hearing today on the allegedly adverse impact of prescription benefit manager practices on rural pharmacies.
  • Beckers Hospital Review looks into a Republican budget reconciliation proposal in Congress to “place a 10-year moratorium on state and local governments regulating AI. The provision would prevent any laws targeting AI models, systems or automated decision tools during that time.”
  • The AHA News informs us,
    • “The Centers for Medicare & Medicaid Services May 13 launched a new strategy focused on three pillars: promoting evidence-based prevention, empowering people to achieve their health goals, and driving choice and competition. To support the new strategic plan, CMS Administrator Mehmet Oz, M.D., and Innovation Center Director Abe Sutton hosted a public webinar highlighting the Innovation Center’s commitment to take learnings from historical investments in value-based care to the “Make America Healthy Again” initiative. They also highlighted the need for models to demonstrate cost savings and improved outcomes in accordance with statutory requirements. The agency posted FAQs regarding the new strategic direction on a new homepage.”
  • and
    • “The Centers for Medicare & Medicaid Services May 12 issued a proposed regulation that would change how states may structure provider taxes for purposes of generating revenue for their Medicaid programs. CMS states that these changes are intended to prevent states from adopting provider taxes that are not “generally redistributive” and therefore may be in violation of the statute. While CMS notes that they have particular concerns about certain Medicaid managed care organization taxes, these policies, if adopted, would apply to all provider taxes. The public has 60 days to comment.”
  • Beckers Hospital Review offers eight things to know about this proposed regulation.
  • The U.S. Preventive Services Task Force confirmed today the continuing validity of its Grade A recommendation of “early, universal screening for syphilis infection during pregnancy [for asymptomatic women]; if an individual is not screened early in pregnancy, the USPSTF recommends screening at the first available opportunity.” * * * “To achieve the benefit of screening, it is important that screening occur as early in pregnancy as possible and that everyone with abnormal syphilis test results receive timely, evidence-based evaluation and treatment.”

From the judicial front,

  • STAT News reports,
    • “The now 13-year-long legal saga over who invented CRISPR took yet another unexpected turn on Monday, in a ruling that could not only change U.S. ownership of patent rights to the groundbreaking gene-editing technology but more broadly redefine how the law determines when an invention has been made. 
    • “The U.S. Court of Appeals for the Federal Circuit sided with the University of California and the University of Vienna in their bid to revive a fight over foundational CRISPR-Cas9 patents that the schools say should go to their Nobel Prize-winning scientists Jennifer Doudna and Emmanuelle Charpentier. In 2022, the U.S. Patent and Trademark Office determined that a group of scientists led by Feng Zhang of the Broad Institute of Harvard and the Massachusetts Institute of Technology had conceived of uses of the technology in humans before Doudna and Charpentier.” 

From the public health and medical research front,

  • From HHS news releases,
    • “The U.S. Food and Drug Administration (FDA) today announced that it is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market. Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers. They have also never been approved by the FDA. Ingested fluoride has been shown to alter the gut microbiome, which is of magnified concern given the early development of the gut microbiome in childhood. Other studies have suggested an association between fluoride and thyroid disorders, weight gain and possibly decreased IQ.
    • “The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health,” said FDA Commissioner Marty Makary, M.D., M.P.H. “I am instructing our Center for Drug Evaluation and Research to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products to better inform parents and the medical community on this emerging area. When it comes to children, we should err on the side of safety.”
  • and
    • “The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) today announced the next steps in Operation Stork Speed–a groundbreaking initiative to ensure the safety, reliability, and nutritional adequacy of infant formula for American families. The FDA issued a Request for Information (RFI) to begin the nutrient review process required by law for infant formula. Currently, infant formula must meet minimum and maximum levels of certain nutrients. While the FDA regularly reviews individual nutrient requirements for infant formula, this will be the first comprehensive review since 1998.
    • “Operation Stork Speed brings radical transparency to ingredients in infant formula and puts science front and center,” said HHS Secretary Robert F. Kennedy, Jr. “Every child has a fundamental right to a healthy start. We’re giving parents the truth and the tools to make that happen. You can’t Make America Healthy Again if we don’t fix what nourishes our youngest and most vulnerable Americans.”
    • “Through the RFI, the FDA is seeking public input to help determine whether existing nutrient requirements should be revised based on the latest scientific data, including international. The agency also welcomes data on potential adjustments to existing minimum or maximum levels, recommendations for additional nutrients to consider, and how such changes may improve health outcomes.
    • “Commenters will have 120 days to submit responses. Further information on how to submit a comment can be found here.”
  • This week’s issue of NIH Research Matters covers the following topics — “Measuring tinnitus | Fat metabolism & pancreatic cancer | Senescent cell subtypes.”
  • The Washington Post reports,
    • “More U.S. high-schoolers used nicotine pouches — smokeless nicotine powder products — last year than the year before, according to new research published in JAMA Network Open.
    • “The researchers, who used data from a nationally representative survey of 10,146 youths in 2023 and 2024, said 5.4 percent of 10th- and 12th-graders reported having used nicotine pouches, up from 3 percent the year before. The 10th- and 12th-graders’ use of pouches in the 12 months and 30 days before the surveys also increased year to year. Males were also more likely to use pouches than females.
    • “Looking at race and ethnicity data, use was highest among White, non-Hispanic 10th- and 12th-grade teens — 9 percent had used a nicotine pouch at some point. Teens in rural areas were also more likely to use the products than urban or suburban youths: In 2024, 11.2 percent of rural youths vs. 5.9 percent of suburban and 3 percent of urban youths said they’d used a pouch.”
  • Per Healio,
    • “Social determinants of health at the community level, such as median income and walkability, have a larger influence on hip replacement outcomes than an individual patient’s race, according to data.
    • “The study was inspired by “persistent disparities observed in total hip arthroplasty outcomes, often attributed to individual factors such as race,” study author Bella Mehta, MD, MBBS, MS, a rheumatologist at Hospital for Special Surgery, told Healio.”
  • Per MedPage Today,
    • “Treating early Alzheimer’s disease patients with lecanemab (Leqembi) was feasible and most patients tolerated the drug well, a retrospective study at one specialty memory clinic showed.
    • “Infusion-related reactions occurred in 37% of 234 Alzheimer’s patients treated with lecanemab and typically were mild, according to Suzanne Schindler, MD, PhD, of Washington University School of Medicine in St. Louis, and co-authors.
    • “Amyloid-related imaging abnormalities (ARIA) emerged in 42 of 194 people (22%) who received at least four lecanemab infusions and had at least one MRI, the researchers reported in JAMA Neurology.
    • “Overall, 29 people (15%) had ARIA with brain edema or effusion (ARIA-E) — with or without ARIA with brain hemorrhage or hemosiderin deposition (ARIA-H), including microhemorrhages and superficial siderosis — and 13 people had isolated ARIA-H (6.7%).
    • “Most ARIA cases were asymptomatic (74%) and radiographically mild (62%). Eleven patients (5.7%) developed symptomatic ARIA; two (1.0%) were patients with clinically severe ARIA symptoms. No patients developed a macrohemorrhage or died.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Andrew Witty is stepping down as chief executive officer of UnitedHealth, citing personal reasons, the healthcare giant announced Tuesday.
    • “Witty, who has run UnitedHealth since 2021, is departing following a sharp downturn in the company’s financial performance from higher medical spending and unfavorable policy changes. He will be replaced effective immediately by Stephen Hemsley, the chairman of UnitedHealth’s board and its CEO from 2006 to 2017.
    • “UnitedHealth also suspended its 2025 guidance on Tuesday, pointing to the ongoing increase in medical care activity.”
  • The Wall Street Journal adds,
    • “In a call with analysts Tuesday, the company said it was seeing medical costs continue to accelerate beyond the trends it flagged last month and signs that the issue was spreading beyond enrollees in its Medicare plans. 
    • “To all stakeholders, including employees and shareholders, I’m deeply disappointed in and apologize for the performance setbacks we have encountered from both external and internal challenges,” Hemsley said. “This company has both the opportunities and capabilities to deliver exceptional services and outcomes for customers, consumers and care providers, and to continue to reliably generate the earnings growth that align with our 13% to 16% long term growth range.”
    • “The company said it expects to return to growth in 2026.”
  • Beckers Payer Issues offers us five things to know about Mr. Hemsley.
  • Beckers Payer Issues also discusses recent developments in the GLP-1 drug market.

Thursday Report

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, NIH, OPM, SDOH, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Senate Press Gallery indicates that the Majority Leader John Thune (R SD) plans to file cloture motions on six Presidential nominees (not including Scott Kupor) on Monday. Nevertheless, this action gives the FEHBlog hope that Scott Kupor’s nomination to be OPM Director will be brought to Senate floor this month.
  • The American Hospital Association News tells us,
    • “Reps. Jennifer McClellan, D-Va., and Don Bacon, R-Neb., and Sens. Jeff Merkley, D-Ore., and Cindy Hyde-Smith, R-Miss., today reintroduced AHA-supported legislation addressing mental health and substance use disorder facility shortages. The Mental Health Infrastructure Improvement Act (H.R. 3266) would establish a new federal loan and loan guarantee program within the Department of Health and Human Services to build or renovate mental health or substance use disorder treatment facilities. At least a quarter of the funding would be reserved for pediatric- and adolescent-serving facilities. The bill would also prioritize facilities located in high-need, underserved or rural areas, and those capable of providing integrated care for patients with complex needs.”
       
  • Federal News Network informs us,
    • “The Office of Personnel Management is hoping the sole-source, one-year contract it just awarded to Workday, a cloud-based HR services company, will help the agency manage what’s turned into a massive influx of HR work.” * * *
    • “The contract with Workday will cover services for HR and personnel processing, payroll and benefits systems, time and attendance tracking, talent acquisition and performance management, all while ensuring compliance with federal requirements, according to the contract award notice.” * * *
    • “The Workday contract, worth $342,200, will last for one year, at the end of which OPM said it plans to conduct an open competition for the next iteration of the HR IT contract.”
  • Per an FDA news release,
    • “In a historic first for the agency, FDA Commissioner Martin A. Makary, M.D., M.P.H., today announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025, following the completion of a new generative AI pilot for scientific reviewers.
    • “I was blown away by the success of our first AI-assisted scientific review pilot. We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies,” said Dr. Makary.
    • “The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process.
    • “This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days,” said Jinzhong (Jin) Liu, Deputy Director, Office of Drug Evaluation Sciences, Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER).”
  • Tammy Flanagan, writing in Govexec, lets us know how Social Security benefits fit into the federal retirement picture.

From the public health and medical research front,

  • Medpage Today points out,
    • “Detections of H5N1 avian influenza have slowed in both animals and humans, but continued surveillance is warranted, CDC researchers said.
    • “In dairy cattle, cases surged over the fall and early winter but eased in January, while cases in poultry flocks fell after February, and came down last month in backyard flocks, according to data on CDC’s website that was shared during a clinician outreach and communication activity (COCA) call on Tuesday.
    • “Most of our human cases are known to be associated with animal exposures, so fewer infections in the animals leads to fewer infections in people,” Alicia Budd, MPH, team lead of the national surveillance and outbreak response team at the National Center for Immunization and Respiratory Diseases (NCIRD), said during the call.
    • “It’s certainly great to see these declines in both animal and human cases, but it’s also critical that we maintain targeted monitoring and our general surveillance, so that if this situation changes, we’d be able to identify that quickly,” Budd added.”
  • and
    • “The nation’s infant mortality rate dropped last year after 2 years of hovering at a late-pandemic plateau.
    • “Some experts think one reason for the drop could be a vaccination campaign against respiratory syncytial virus (RSV)opens in a new tab or window, which is a common cause of cold-like symptoms that can be dangerous for infants.
    • “The infant mortality national rate dropped to about 5.5 infant deaths per 1,000 live births in 2024, according to provisional data from the CDC posted Thursday. That’s down from about 5.6 per 1,000 live births, where it had been the previous 2 years.
    • “CDC officials believe the findings will not change much when the final numbers come out later this year.”
  • Per Healio,
    • “Tobacco-related ischemic heart disease mortality has increased in the U.S. since 1999.
    • “The aging of the population and the introduction of novel nicotine products may be among the drivers.”
  • and
    • “A risk prediction model assesses seven variables to determine the best intervention for lowering type 2 diabetes risk.
    • “Intensive lifestyle intervention was the optimal treatment strategy for most adults.”
  • Per Cardiovascular Business,
    • “Cardiovascular risk factors such as obesity and high blood pressure are much more prevalent in some parts of the United States than others—and some of those gaps are only widening as time goes on. 
    • “That was the biggest takeaway from a new analysis published in The American Journal of Cardiology. The study’s authors reviewed answers to the Behavioral Risk Factor Surveillance System (BRFSS) survey from 2011 to 2021 to track changes in various health inequities over time.
    • “Delays in preventive care and screening as well as economic loss, disruptions in insurance coverage and worsening social determinants of health (food insecurity, housing instability) have fallen more heavily on low-income, minority and rural communities since the pandemic,” wrote first author Rachel K. Gardner, MD, a researcher with Beth Israel Deaconess Medical Center and Brigham and Women’s Hospital, and colleagues. “In addition, the spillover effects of the pandemic have disproportionately impacted some U.S. states more than others. Together, these changes could have profound implications for cardiovascular health across the country. However, little is known about how inequities in the burden of cardiometabolic and lifestyle risk factors across U.S. states have changed, especially since the pandemic. Understanding these epidemiological changes in place-based inequities is critically important and could inform targeted public health and policy interventions at the state- and national-level to advance cardiovascular health.”
    • “The BRFSS survey is the world’s largest continuous health survey of its kind, collecting data from more than 400,000 adult participants each year. Gardner et al. based their comparison on data from 506,467 adults who participated in the survey in 2011 as well as 438,693 who participated in 2021.” * * *
    • Click here for the full study.
  • Beckers Hospital Review reports,
    • “Moderna’s new combination vaccine for seasonal influenza and COVID-19 has outperformed current standard vaccines in a large phase 3 clinical trial, showing stronger immune responses to both viruses in adults 50 years or older. 
    • “The findings, published May 7 in JAMA Network, come from a randomized study of more than 8,000 participants conducted across 146 U.S. sites. Participants either received the investigational combo vaccine mRNA-1083 or the standard influenza and COVID-19 vaccines recommended for their age group. 
    • “Among adults ages 50 to 64, mRNA-1083 generated a stronger immune response against all four influenza strains. In adults 65 and older, it outperformed the high-dose flu vaccine in three of the four strains. In both age groups, the vaccine also produced higher immune responses to SARS-CoV-2 compared to standard COVID-19 vaccine.”
  • The National Institutes of Health announced,
    • “Researchers at the National Institutes of Health (NIH) have completed a comprehensive analysis of cancer statistics for different age groups in the United States and found that from 2010 through 2019, the incidence of 14 cancer types increased among people under age 50. Of these cancer types, nine—including several common cancers, such as breast cancer and colorectal cancer—also increased in some groups of people aged 50 and older. However, the incidence of 19 other cancer types—including lung cancer and prostate cancer—decreased among people under age 50, so the total rate of all cancers diagnosed in both younger and older age groups did not increase, nor did the rate of cancer death.
    • “This study provides a starting point for understanding which cancers are increasing among individuals under age 50,” said lead investigator Meredith Shiels, Ph.D., of NIH’s National Cancer Institute. “The causes of these increases are likely to be cancer specific, including cancer risk factors becoming more common at younger ages, changes in cancer screening or detection, and updates to clinical diagnosis or coding of cancers.”
    • “The study appeared May 8, 2025, in Cancer Discovery“.
  • The National Cancer Institute adds,
    • “Scientists have developed a method of rapidly measuring the levels of certain genetic mutations in brain tissue samples collected from patients during surgery. 
    • “In a new study, researchers showed that the droplet digital polymerase chain reaction (ddPCR) method they developed could produce results in 15 minutes—the first time ddPCR has generated results so quickly. 
    • “Their tool accurately measured the levels of tumor cells in dozens of brain tissue samples, they reported. And it detected minute numbers of cancer cells, as few as five cells per square millimeter, according to findings published February 25 in Med.
    • “The researchers developed the tool, which they call Ultra-Rapid ddPCR, to provide surgeons with information that could potentially help guide their decision-making during surgery.
    • “This new technology could be an additional source of information for a surgeon who is deciding whether to keep removing tissue during an operation,” said study co-leader Daniel Orringer, M.D., a neurosurgeon at NYU Grossman School of Medicine. “If the test detects tumor cells at a surgical margin, then surgeons could decide to keep cutting.”

In Food and Drug Administration News,

  • Cardiovascular Business reports,
    • “The U.S. Food and Drug Administration (FDA) has approved the balloon-expandable Sapien 3 transcatheter aortic valve replacement (TAVR) platform from Edwards Lifesciences for treating asymptomatic severe aortic stenosis (AS). 
    • “This is the first time the FDA has approved any TAVR technology in asymptomatic patients. The decision covers the Sapien 3, Sapien 3 Ultra and Sapien 3 Ultra Resilia TAVR valves.
    • “This approval is a powerful opportunity to streamline patient care and improve the efficiency of the healthcare system,” Larry Wood, Edwards’ corporate vice president and group president of TAVR and surgical technologies, said in a statement announcing the news. “We are proud to partner with leading physicians to advance our knowledge of this deadly disease with high quality science and optimize the treatment pathway for patients.”
  • Per Medical Economics,
    • “BrightHeart, a Paris-based artificial intelligence company for obstetrics and pediatric cardiology, announced it has received FDA 510(k) clearance for an updated version of its BrightHeart platform. The new approval allows clinicians to access the company’s AI-driven analysis in real time using a cart-side tablet during fetal ultrasound exams.
    • “The technology aims to address a persistent clinical challenge: detecting congenital heart defects (CHDs) in utero. CHDs are the most common type of birth defect, but up to 70% go undiagnosed during standard prenatal ultrasounds, according to the company.
    • “BrightHeart’s AI platform flags potential structural abnormalities in the fetal heart, helping to alert clinicians to possible CHDs during routine exams. The company says the real-time tablet integration streamlines workflows and improves the accuracy of screenings.
    • “Our product expansion builds upon the success of our initial pilot experience, bringing real-time feedback directly to the clinicians to streamline the workflow and enhance accuracy,” said Cécile Dupont, CEO of BrightHeart and partner at Sofinnova Partners. “We were thrilled to achieve clearance through our first Special 510(k) submission within just a few months.”

From the U.S. healthcare business front,

  • Medical Economics reports,
    • “Nonphysician providers now make up more than two out of every five health care professionals in the United States, as hospitals and medical groups increasingly rely on advanced practice providers to meet growing patient demand and improve efficiency, according to a new report from Kaufman Hall.
    • “The Physician Flash Report, released by the health care consulting firm and its parent company Vizient, found that 40.6% of the nation’s provider workforce is composed of APPs such as nurse practitioners and physician assistants. The report points to continued growth in this segment and predicts that APPs and physicians may soon comprise equal halves of the clinician workforce.
    • “Advanced practice providers like physician assistants and nurse practitioners play a vital and increasingly visible role in health care,” said Matthew Bates, managing director and Physician Enterprise Service Line leader with Kaufman Hall. “When deployed correctly, advanced practice providers let physicians practice at the top of their license. They give doctors more time to focus on diagnosis and treatment, which can make physician practices more efficient and address other challenges, including physician burnout.”
  • Reuters tells us,
    • “Another Big Pharma is opening up its wallet to pour billions into its U.S. operations amid political pressure from the Trump administration.
    • “This time it’s Gilead coming to the table with a fresh $11 billion in hand to spend across its manufacturing and research centers in the U.S.
    • “Gilead broke down the new spending routes in a Wednesday release. The majority, $5 billion, will be funneled into technology, operations, and R&D site activities, while $4 billion will go into capital projects, including labs and equipment. The final $2 billion will be “invested in digital and advanced engineering initiatives,” the pharma said.”
  • The White House summarized all of these drug manufacturing investments here.
  • Fierce Healthcare relates,
    • “Ayble Health, a virtual GI clinic, has teamed up with Priority Health, a nonprofit health plan in Michigan, to offer commercial members access to the digestive health solution. 
    • “Ayble relies on a multidisciplinary care team, AI-powered nutrition and psychology programs and wellness tools to manage symptoms. Starting June 1, Ayble will be available as a standard benefit for Priority members who have a MyPriority HMO or employer health plan. More than 500,000 adult members will have access. 
    • “When it comes to sourcing solutions like Ayble Health, Priority Health looks for approaches that can improve care quality, engage patients effectively and provide cost-efficient services,” Alicia Coronas, vice president of employer solutions product and marketing at Priority, told Fierce Healthcare. “We evaluate solutions to find the best-in-class partner that is aligned to our vision and mission.”

Tuesday Report

David Ermer–Congress, FDA, SDOH, U.S. Healthcare–

From Washington, DC

  • Per HHS press releases,
    • “The U.S. Department of Health and Human Services (HHS) announced today that Secretary Robert F. Kennedy, Jr. renewed the public health emergency declaration addressing our nation’s opioid crisis, which will allow sustained federal coordination efforts and preserve key flexibilities that enable HHS to continue leveraging expanded authorities to conduct certain activities in response to the opioid overdose crisis.
    • “Although overdose deaths are starting to decline, opioid-involved overdoses remain the leading cause of drug-related fatalities,” HHS Secretary Kennedy said. “This Administration is going to treat this urgent crisis in American health as the national security emergency that it is. Renewing the Opioid Public Health Emergency Declaration affirms the Administration’s commitment to addressing the opioid overdose crisis and is one of many critical steps we will take to Make America Healthy Again.”
  • and
    • “Today, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug Administration is taking steps to enhance its efforts to ensure the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply.
    • “The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them,” said HHS Secretary Kennedy. “Helping each family and child get off to the right start from birth is critical to our pursuit to Make America Healthy Again.”
    • “The FDA is announcing a set of actions and initiatives focused on infant formula, such as beginning the nutrient review process and increasing testing for heavy metals and other contaminants. The agency is also encouraging companies to develop new infant formulas and clarify opportunities to help inform consumers about formula ingredients. These enhanced FDA commitments are focused on making sure a strong supply of the sole source of nutrition for formula-fed babies and children remains available for one of our nation’s most vulnerable populations.”
  • STAT News reports,
    • “In a last-ditch effort to turn its fortunes around, Anson General [ located in Anson, a West-Central Texas town of roughly 2,300 people] applied to be a Rural Emergency Hospital, a new type of hospital Congress created in 2023 to keep rural hospitals afloat. The government pays these hospitals a fixed sum each month — over $3 million annually — instead of reimbursing them for the inpatient services they provide. Medicare also adds 5% to their payments for outpatient services. For Anson General, those monthly checks of roughly $270,000 have brought it back from the brink. 
    • “And yet, just 38 hospitals have taken up the new designation since 2023, fewer than researchers had predicted. Many of them are hospitals like Anson General, whose leaders felt they had no other choice. 
    • “It would seem to be a stopgap to the hospital closure crisis,” said Brock Slabach, chief operations officer of the National Rural Health Association. “In that sense, I think it’s fulfilling its mandate.” * * *
    • “Becoming a REH means giving up inpatient care. These hospitals still operate emergency rooms and treat patients on an observation basis, which can entail overnight stays, as well as provide outpatient care and operate labs.
    • “For most eligible hospitals, though, the cons outweigh the pros. The biggest downside, several hospital leaders said, is the fact that REHs can’t have swing beds. A swing bed is a hospital bed that can be used to provide both acute care and post-acute rehabilitation. They’re especially important in rural communities, which don’t always have nursing homes or rehabilitation facilities. In those areas, patients travel elsewhere for surgeries and return to swing beds in their local hospitals to recover and receive occupational or physical therapy. 
    • “U.S. Sens. Jerry Moran (R-Kan.), and Tina Smith, (D-Minn.), introduced a bill dubbed REH 2.0 that would make several tweaks to the designation, including allowing the hospitals to have swing beds, though it wouldn’t make them eligible for 340B discounts.” 
  • Reuters lets us know,
    •  The U.S. Food and Drug Administration (FDA) issued a warning on Friday, advising consumers against inhaling products containing nitrous oxide, commonly known as ‘laughing gas,’ due to potentially serious side effects, including death.
    • Nitrous oxide is an odorless, colorless gas that leads to euphoria, relaxation, and dissociation from reality when inhaled.” * * *
    • “It is available in compact, affordable cartridges that are easily accessible and sold under various brand names, including Galaxy Gas, Baking Bad, and Miami Magic.
    • “The FDA cautioned against the improper use of these products in any canister, tank, or charger size, as misuse could result in severe health issues, including blood clots, loss of consciousness, paralysis, psychiatric disorders, and even death.”

From the public health and medical research front,

  • Health Day tells us,
    • “Nearly 1 in 3 children live with a chronic condition that could significantly affect their health for the rest of their lives, a new study says.
    • “Chronic illnesses affected more than 30% of children ages 5 to 17 by 2018, up from around 23% in 1999, researchers report in the journal Academic Pediatrics.
    • “This adds up to about 130,000 more children each year being diagnosed with a chronic illness.
    • “This increase has been driven by diagnoses of ADHD/ADD, autism, asthma, prediabetes and mood disorders like depression or anxiety, lead researcher Lauren Wisk, an assistant professor of medicine at the David Geffen School of Medicine at UCLA, said in a news release.”
  • Health Leaders offers “Social Determinant of Health Considerations for CMOs.”
  • Healio relates,
    • “Women with chronic pelvic pain disorders who engaged in moderate to vigorous physical activity had improved mental health scores vs. those who did not, according to study results published in the Journal of Pain Research.
    • “Moderate to vigorous intensity physical activity could be a beneficial way for patients who have a chronic pelvic pain disorder to manage their overall mental health,” Ipek Ensari, PhD, assistant professor in the department of artificial intelligence and human health at the Icahn School of Medicine at Mount Sinai, told Healio. “This seems to be a consistent effect, because even after we adjusted for things like physical pain, physical function and pre-existing psychiatric diagnoses, we still saw this positive significant association between physical activity, behavior and their mental health and well-being at each week as we looked at the results.”
  • Sadly, BioPharma Dive reports,
    • A young man with Duchenne muscular dystrophy has died following treatment with Sarepta Therapeutics’ gene therapy Elevidys, the company said Tuesday.
    • In a short statement, Sarepta said the patient suffered acute liver failure after receiving Elevidys, the only approved gene therapy for the disease. Liver damage is a known risk of treatment with Elevidys as well as other gene therapies that are built around a type of modified virus. The death is the first reported among the more than 800 people in clinical testing and commercially who been treated with the therapy, however.
    • “According to Sarepta, testing showed the patient had a recent infection with cytomegalovirus, a common virus that for most people doesn’t cause symptoms but can lead to serious health issues in those with weakened immune systems. A treating physician cited the infection as a “possible contributing factor” to the death, as cytomegalovirus can infect and damage the liver, leading to hepatitis.
    • “The company reported the death to study investigators, physicians and health authorities. It plans to update Elevidys’ prescribing information to “appropriately represent the event.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “DispatchHealth Tuesday announced a definitive agreement to acquire Medically Home, which would create one of the nation’s largest providers of home-based healthcare services.
    • “The combined company would offer an array of home-based medical services, including urgent care, acute-level care and skilled nursing to patients in 50 metropolitan markets across 23 states and the District of Columbia, with approximately 2,200 employees.
    • “Neither company would disclose financial terms of the deal, which is expected to close by the middle of the year, pending regulatory approval.”
  • and
    • “Patina Health rolled out a new program Tuesday that will provide expanded home-based care to Medicare Advantage members.
    • “The Bala Cynwyd, Pennsylvania-based company said Patina Total Health will provide health assessments, medication management, primary care, urgent care and behavioral health services to older adults in their homes through in-person and telehealth visits. Patina Health is launching the new initiative later this week with a national insurer in Charlotte, North Carolina, the company said in a news release. The company did not disclose the name of the insurer but hopes to ultimately work with multiple Medicare Advantage plans.”
  • and
    • “GE HealthCare announced on Tuesday that it is partnering with Nvidia to work on autonomous X-ray and ultrasound scanners that will leverage artificial intelligence-enabled software to capture and analyze medical images.
    • “The company is developing the technology to help ease the burden of rising patient volumes and staff shortages on healthcare professionals, Roland Rott, president and CEO of imaging at GE HealthCare, said in a news release.”
  • Per Fierce Healthcare,
    • Food delivery and engagement company FarmboxRx will launch Drivers Health, a social determinants of health (SDOH) product line for health plans to better serve their members.
    • FarmboxRx combines food as medicine with health literacy to drive member behavioral change, most notably for members living in food deserts. Drivers Health, starting in June, will act as a care management intervention to connect members to underutilized benefits through food deliveries, founder and CEO Ashley Tyrner-Dolce said in an interview with Fierce Healthcare.
    • “We’ve always had health literacy in the box,” she said. “What Drivers Health is built around is connecting to that care … where we take on that care management piece for the health plan through our member contact center.”
    • “Drivers Health will be an additional product line offered to plans with Medicare, Medicaid and duals members. Many people make difficult financial decisions, having to choose between paying a bill, buying food or refilling a medication. Yet members often don’t realize the full scope of benefits available to them unless there is adequate outreach, said Tyrner-Dolce. These benefits can include transportation, utility or mail-order pharmacy perks.”

Happy Lincoln’s Birthday

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medicare, OPM, Rx coverage, SDOH, U.S. Healthcare–

Our greatest President

From Washington, DC

Capitol Hill News

  • The American Hospital Association (AHA) News tells us,
    • House Republicans Jan. 12 released a budget resolution for fiscal year 2025 focusing on the Trump administration’s agenda on border security, defense, energy and taxes. The budget resolution, which acts as an outline for the reconciliation process, calls for increasing the debt ceiling by $4 trillion and allows for $4.5 trillion in spending for tax cuts. It also would allocate $200 billion for border and defense spending. The resolution instructs seven committees to come up with no less than $1.502 trillion in mandatory cuts over ten years. 
    • Notably, for health care, the bill instructs the House Energy and Commerce Committee to cut mandatory spending by no less than $880 billion. The committee has primary jurisdiction over a number of health care programs, including Medicaid, and some proposals have been circulating that would enact significant cuts to Medicaid. The House is expected to mark up its budget resolution tomorrow. 
  • Politico adds,
    • “Senate Republicans easily pushed their budget resolution out of committee on Wednesday — the first step toward being able to enact President Donald Trump’s massive domestic policy agenda.
    • “The Senate Budget Committee voted 11-10, along party lines, to approve the fiscal framework meant to tee up a package of energy, border security and defense policy through the partisan budget reconciliation process. Across the Capitol, House GOP leaders struggled at the same time to rally their own around a far more expansive plan that would pave the way for legislation that would bundle those same policies alongside trillions of dollars in tax cuts.”
  • The Senate Invoked, 53-47: Motion to invoke cloture on Executive Calendar #17 Robert F. Kennedy, Jr. to be Secretary of HHS. The Senate is expected to confirm Mr. Kennedy’s nomination as HHS Secretary Thursday morning.
  • Fierce Healthcare lays out the “top policy issues for hospitals, payers, docs and tech” on Capitol Hill this year.

White House news

  • Here is a link to the President’s February 11 executive order captioned “IMPLEMENTING THE PRESIDENT’S “DEPARTMENT OF GOVERNMENT EFFICIENCY” WORKFORCE OPTIMIZATION INITIATIVE,” which was mentioned in Tuesday’s report.
  • The American Society of Pension Professionals and Actuaries lets us know,
    • “Daniel Aronowitz has been officially nominated by the White House to become next Assistant Secretary of Labor for the Employee Benefits Security Administration (EBSA). He is the President of Euclid Fiduciary (now Encore Fiduciary), a fiduciary liability insurance underwriting company for employee benefit plans.
    • “His experience in the professional liability industry includes expertise as a coverage lawyer and underwriter.”
  • The AHA News informs us, “Tom Engels is the new administrator for the Health Resources and Services Administration, according to its website. Engels previously held the same position in the first Trump administration from 2019 to 2021.”
  • Federal News Network updates us on federal agency efforts to bring their workforces back to office.

Judicial front

  • Federal News Network reports,
    • “The Trump administration is free to continue implementing its controversial deferred resignation program after a federal court in Massachusetts dissolved a restraining order that had delayed the program’s deadline by several days.
    • “In a written opinion Wednesday afternoon, Judge George O’Toole said he had determined that the three federal unions that had challenged the program lacked the standing they’d need in order to meet the legal standard for a temporary restraining order.” * * *
    • “Wednesday’s ruling does not completely end the legal challenge — it only affects the unions’ requests for a temporary pause in the deferred resignation program while their claims work their way through the litigation process. However, in denying a temporary restraining order and preliminary injunction, O’Toole said he had determined the unions were unlikely to succeed on the merits of their case.
    • “OPM is pleased the court has rejected a desperate effort to strike down the deferred resignation program. As of 7 p.m. tonight, the program is now closed,” said McLaurine Pinover, a spokeswoman for the office. “There is no longer any doubt: the deferred resignation program was both legal and a valuable option for federal employees. This program was carefully designed, thoroughly vetted, and provides generous benefits so federal workers can plan for their futures.”
    • In fact, the Fork in the Road program closed at 7:20 pm ET Wednesday night per its website.

FDA News

  • Fierce Pharma notes,
    • “More than 13 years after its initial FDA approval, Pfizer’s blood cancer drug Adcetris has nabbed another regulatory green light to treat large B-cell lymphoma (LBCL).
    • “The CD30-directed antibody-drug conjugate has been approved in combination with lenalidomide and rituximab for certain LBCL patients, the FDA said Wednesday. Eligible patients must have tried at least two prior lines of systemic therapy and be ineligible for an autologous hematopoietic stem cell transplant or a CAR-T therapy.
    • “Adcetris won the approval after showing it helped patients with heavily pretreated LBCL live longer in a phase 3 trial.”

From the public health and medical research front,

  • CBS News reports,
    • “For the first time since the beginning of the pandemic, more people in the U.S. died of influenza than from COVID-19 in the week ending on Jan. 25, according to weekly figures published by the Centers for Disease Control and Prevention.
    • “For the week ending on Jan. 25, nearly 1.7% of all deaths nationwide were attributed to the flu, compared to roughly 1.5% being the result of COVID-19, according to CDC data. Rates of influenza hospitalizations are more than three times higher than COVID-19 hospitalizations amid this season’s record wave of flu infections.”
  • and
    • “The U.S. confirmed at least a dozen deaths from whooping cough last year, according to preliminary figures released this week by the Centers for Disease Control and Prevention. That marks the most fatalities from the bacterial infection since a 2017 surge of the illness, which is also known as pertussis.
    • “Over the last month, pertussis infections have been rising again. While cases reported to the CDC by health departments dipped over the winter holidays, weekly infections have accelerated for a month straight since then.”
  • The New York Times adds,
    • “A worsening measles outbreak has taken root in Texas, sickening two dozen and hospitalizing nine on the western edge of the state, where childhood vaccination rates have dwindled in recent years.
    • “As of Tuesday, 22 children and two adults had been infected, all of whom were unvaccinated, local health officials said. * * *
    • “The Texas outbreak has so far been limited to residents of Gaines County, which borders New Mexico and has roughly 20,000 residents. Last year 82 percent of kindergarten students received the measles, mumps and rubella vaccine, according to state data. That figure is roughly 10 percentage points lower than the average vaccination rate in Texas public schools and far below the federal target of 95 percent for measles vaccination.”
  • Nature points out that “Dozens of new obesity drugs are coming; these are the ones to watch. Next-generation obesity drugs will work differently from Ozempic and Wegovy — aiming to deliver greater weight loss with fewer side effects.”
  • BioPharma Dive, on the other hand, lets us know “A small semaglutide trial suggests the medicine’s suppression of appetite may extend to alcohol, but larger trials are needed to establish a conclusive benefit.”
  • Per Fierce Healthcare,
    • “More than five years ago, Apple launched three medical studies to test how well its Apple Watch can track a person’s mobility and cardiovascular health, changes in hearing and women’s health and fertility.
    • “The tech company is now broadening its health research ambitions to use its devices, including iPhones, Apple Watch and AirPods along with third-party devices, for a longitudinal, virtual study to monitor changes in participants’ health, spanning a wide range of health and disease areas.
    • “Apple wants to tap into the devices and apps that individuals use every day to evaluate the connections between physical and mental health as well as social determinants, such as whether someone lives alone or with family, and how all these aspects of health factor into a person’s overall well-being.”

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • “CVS Health’s profits were nearly cut in half last year as the healthcare giant wrestled with elevated medical costs in its Aetna insurance business. 
    • “The company reported net income of $4.6 billion in 2024, compared with $8.4 billion in the prior year, according to earnings results released Wednesday. 
    • “But CVS showed signs of financial improvement in the fourth quarter, beating Wall Street expectations on earnings and revenue.” 
  • Bloomberg explains,
    • “In the insurance unit, CVS spent 94.8% of premium revenue on medical care in the quarter, less than analysts expected. Investors prefer a lower number. However, CVS said in a separate filing that high use of medical services will continue to pressure the business. 
    • “The company pointed in particular to high costs in its business that manages care for patients on Medicaid, the US health program for the poor. States have been cutting Medicaid rolls since the pandemic, often culling healthier patients in the program while sicker patients remain.” 
  • Fierce Healthcare adds,
    • “CVS Health CEO David Joyner went on the defense of the pharmacy benefit management industry on the company’s Q4 earnings call Wednesday morning.” * * *
    • “One of the most powerful forces helping to offset rising healthcare costs is PBMs like Caremark,” Joyner said. “These entities remain the only part of the drug supply chain and entirely focused on lowering costs, but have erroneously been subject to deceptive rhetoric and misinformation.”
    • “Joyner noted that branded pharmaceutical manufacturers “added $21 billion of annual gross drug spend through their price actions” in January. Drugs where PBMs lack tools to negotiate prices have seen prices rise more than twice as fast as other products, he said.
    • “In addition, Joyner said that “multiple well-known economists” have projected that PBMs create $100 billion in net value each year for the healthcare system.”
  • Per the AHA News,
    • The Council for Affordable Quality Healthcare Feb. 11 released a report  highlighting how the health care industry can save $20 billion by transitioning from manual to electronic workflows.  
    • In addition, it found that the industry could save $515 million annually on electronic prior authorizations and save providers and staff 14 minutes per transaction.
  • Per Fierce Healthcare,
    • “UnitedHealth Group and Amedisys outlined plans to divest a significant number of home health and hospice locations as they seek to close their $3.3 billion merger.
    • “In a court filing issued late last week, UHG said it intends to pursue a divestiture plan that would sell off “at minimum” 128 combined home health and hospice facilities. The company said in the filing that once the divestitures are completed it will operate only 10% of home health services in the U.S. and 4% of hospice services.
    • “UnitedHealth argued that leaves plenty of competition in this space, as it will still be up against 11,000 home health agencies and more than 5,000 hospice agencies across the U.S.
    • ‘The Department of Justice sued to block the deal in mid-November, arguing that it would hamper competition across multiple home health markets.”
  • Per JAMA Open,
    • “Question How have the proportion and absolute number of psychiatrists providing professional services to traditional Medicare enrollees changed as the field has grown?
    • “Findings In this cross-sectional study using data from 2014 to 2022, the nationwide proportion of psychiatrists billing Medicare Part B declined from 44% in 2014 to 33% in 2022. The number of psychiatrists billing Medicare Part B declined by 3772 during a time when the total number of active psychiatrists increased by 6076.
    • “Meaning These findings suggest that during a time of psychiatrist workforce growth, the proportion and number of psychiatrists accepting Medicare Part B decreased, further suggesting potential decreases in access to psychiatrist-led care for older adults and individuals with disabilities.”

Friday Report

David Ermer–CDC, Congress, COVID-19, Medical / Rx research, OPM, Rx coverage, SDOH, U.S. Healthcare–

From Washington, D.C.

  • Roll Call reports,
    • “The Senate fiscal 2025 budget resolution released Friday gives instructions to nine authorizing committees to draft a filibuster-proof reconciliation bill aimed at strengthening border control, buttressing military spending and encouraging domestic energy production.
    • “The fiscal blueprint, written by Senate Budget Chairman Lindsey Graham, R-S.C., gives the authorizing committees until March 7 to fill in the details and provide their respective pieces of the package to the Budget Committee, which will then meld them into one bill.
    • “The plan, to be marked up by the committee Feb. 12 and 13, assumes $342 billion over four years divided between border security, the Pentagon and Coast Guard: $175 billion for the border, $150 billion for defense and $17 billion for the Coast Guard.
    • “The new funding would be fully paid-for, but how they do that specifically is up to the authorizing committees charged with drafting the implementing bill. Committees given instructions to come up with the offsets are given low targets — at least $1 billion — to provide them with maximum flexibility. But the expectation is those committees will exceed those targets.”
  • and
    • “House Republican leaders emerged late Thursday from a roughly three-hour meeting without an agreement on the contours of the massive budget reconciliation package they’ve been talking about for weeks.
    • “But they planned to work through the weekend ironing out details with a goal of marking up the blueprint needed for the filibuster-proof bill early next week.
    • “Speaker Mike Johnson said he’ll be working Saturday and through Sunday’s Super Bowl taking place in New Orleans — in his and Majority Leader Steve Scalise’s home state of Louisiana. President Donald Trump, who hosted House GOP leaders for several hours to discuss reconciliation earlier in the day, is slated to attend the game Sunday.
    • “We are almost there,” Johnson said. “A couple final details that we’ve got to work out.”
  • The Washington Post reports
    • A federal judge said Friday he will temporarily bar the U.S. Agency for International Development from putting 2,200 workers on paid leave as planned by the end of the day after employee groups filed a lawsuit challenging the Trump administration’s authority to shut down the agency.
    • U.S. District Judge Carl J. Nichols said after a hastily called hearing that he will enter a “limited” order in the lawsuit, brought Thursday, and was still weighing whether to order the government to undo the decision to place an additional 500 workers on paid leave.
    • Nichols said he would explain his decision in writing Friday evening, and cautioned that his freeze would be temporary while both sides flesh out their complex but hastily sketched-out claims.
  • OPM on its Fork in the Road webpage acknowledges the federal court order extending the “deadline for the Deferred Resignation Program, the deadline for federal employees to accept the program is being extended to Monday, February 10, at 11:59 pm ET.
  • MedTech Dive tells us,
    • “The American Hospital Association (AHA) has called for the Trump administration to exempt medical devices from tariffs on imports from Canada, China and Mexico.
    • “In a letter sent to President Donald Trump Tuesday, AHA CEO Richard Pollack said disruption to the supply of devices from China would curtail hospitals’ ability to perform life-saving surgeries, protect patients and healthcare workers from contagion, and diagnose and monitor patient conditions.
    • “The AHA is particularly concerned about products that are already in short supply despite ongoing efforts to strengthen the domestic supply chain, Pollack said.”
  • The Government Accountability Office released a report on the Postal Service today.
    • “The U.S. Postal Service is consolidating some of its mail processing facilities. Before doing so, USPS must give public notice of the proposed changes and provide information on how the changes will affect costs, employees, and mail service.
    • “But we found that USPS’s process for estimating the costs of these changes doesn’t align with best practices we considered. For example, USPS doesn’t document all the assumptions and methodologies it uses to develop cost estimates. This information would help decision-makers and oversight groups better understand any risks or uncertainty involved in the estimates.
    • ‘Our recommendations address this issue.

From the public health and medical research front,

  • Fierce Pharma points out,
    • “Since 1999, Feb. 7 has marked National Black HIV/AIDS Awareness Day, drawing attention to the disproportionate impact of HIV on Black communities.
    • “For ViiV Healthcare—the HIV-focused joint venture between GSK, Pfizer and Shionogi—the day represents a dual opportunity to both celebrate progress and plan next steps, according to Randevyn Pierre, ViiV’s head of national field engagement in external affairs.
    • “It’s the moment for us to remember those who have contributed so much to this fight to end HIV/AIDS, and it’s an opportunity for us to celebrate how far we’ve come in HIV treatment, advocacy, activism, research and community work, and also to use that as evidence of how far we can go to end HIV,” Pierre said in an interview with Fierce Pharma Marketing.”
  • The Centers for Disease Control and Prevention announced
    • “Seasonal influenza activity remains elevated and continues to increase across the country. COVID-19 activity is elevated in many areas of the country. RSV activity is declining in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is elevated in many areas of the country. Though wastewater levels are high, emergency department visits are at low levels, and laboratory percent positivity is declining. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • ‘RSV
      • “RSV activity remains elevated but is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • ‘Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The University of Minnesota’s CIDRAP informs us,
    • “Infection with the SARS-CoV-2 Omicron variant confers weak, short-term protection against reinfection, compared with the much more robust and durable protection provided by earlier variants, which highlights the need for periodic vaccine updates, a Cornell University Qatar–led study suggests.
    • ‘The researchers used a test-negative, case-control study design to compare the efficacy of SARS-CoV-2 Omicron infection against reinfection and poor outcomes in Qataris with that offered by infection with previously dominant strains such as Alpha, Beta, and Delta. COVID-positive people were matched with COVID-negative controls in a 1:2 ratio by sex, age-group, nationality, number of underlying medical conditions, vaccine doses received, week of COVID-19 test, testing method, and reason for testing.
    • “The results were published yesterday in Nature. today.”
  • and
    • “Researchers today in JAMA Network Open say children with previous COVID-19 infection have a 25% to 28% higher risk of developing new gastrointestinal (GI) tract symptoms for up to 2 years than kids who did not report SARS-CoV-2 infections.
    • “Studies in adults have shown that the risk of developing new GI symptoms, including abdominal pain, irritable bowel syndrome (IBS), and gastroesophageal reflux disease (GERD), is increased in the year following COVID-19 infection, but it is unknown if kids are at the same increased risk.” 
  • Beckers Clinical Leadership adds “Flu cases reach highest levels since 2009 pandemic: 6 respiratory virus updates.”
    • “Flu levels have surged to their highest levels since the 2009 swine flu pandemic, with influenza-related emergency department visits remaining very high across the U.S. 
    • “The flu continues to drive the most respiratory illness activity and officials warn that flu-related emergency department visits are expected to remain high in the coming weeks. “
  • The American Hospital Association News lets us know.
    • “A study by the Penn State Department of Nutritional Sciences found that low vitamin D levels in the first trimester of pregnancy are associated with higher rates of preterm birth and decreased fetal length.    
    • “More than 25% of women who are pregnant or lactating have lower than recommended levels of vitamin D,” said Alison Gernand, one of the study’s authors.   
    • “Women with higher levels of vitamin D were found to have experienced small but statistically significant increases in fetal length.”
  • The New York Times reports,
    • “Hospital and emergency room patients diagnosed with cannabis use disorder — defined as an inability to stop using cannabis even when the drug is causing harm — died at almost three times the rate of individuals without the disorder over the next five years, according to a study published on Thursday, the largest on the subject.
    • ‘Patients with cannabis use disorder were 10 times as likely to die by suicide as those in the general population. They were also more likely to die from trauma, drug poisonings and lung cancer. Those numbers suggest that cannabis use disorder is about half as dangerous as opioid addiction and slightly less dangerous than alcohol use disorder, the researchers said.
    • “A second report, published on Tuesday, found that more cases of schizophrenia and psychosis in Canada have been linked to cannabis use disorder since the drug was legalized.
    • “Many people think, ‘Oh, cannabis is not harmful — it’s organic, it’s natural; how great,’” said Dr. Laura Bierut, a psychiatrist at Washington University School of Medicine in St. Louis who is an author of an editorial accompanying the study of death risk. But the marijuana sold today is far more potent, and more harmful, than what baby boomers smoked in the 1960s and 1970s, she said.”
  • Per Healio,
    • “Central obesity measures of waist circumference and waist-to-hip ratio appear to be more accurate and consistent indicators of colorectal cancer incidence compared with BMI, according to a study published in JAMA Network Open.“
  • and
    • “A blood-based biomarker test may be a reliable method for predicting or ruling out Alzheimer’s disease-related pathology and subsequently for assisting clinicians in formulating a treatment plan for patients, according to new research.
    • “The clinical integration of blood biomarkers for AD holds promise in enabling the early detection of pathology and timely intervention,” Mark Monane, MD, MBA, senior medical adviser at C2N Diagnostics, which funded the study, and colleagues wrote in Diagnostics. “The use of a blood biomarker test that is scalable and accessible as well as acceptable and equitable may address the unmet need in diagnostic testing.”

From the U.S. healthcare business front,

  • Beckers Hospital Review lets us know,
    • “Oakland, Calif.-based Kaiser Permanente posted an operating income of $569 million (0.5% operating marin) in 2024, up from an operating income of $329 million (0.3% margin) in 2023, according to its Feb. 7 financial report. 
    • “Kaiser’s 2024 results include Risant Health, the Washington, D.C.-based nonprofit it formed to “to expand and accelerate the adoption of value-based care in diverse, multi-payer, multi-provider, community-based health system environments.” Risant closed the acquisition of its first health system, Danville, Pa.-based Geisinger, on March 31. It closed the acquisition of its second, Greensboro, N.C.-based Cone Health, on Dec. 1. 
    • “Kaiser reported operating revenues of $115.8 billion for the fiscal year ended Dec. 31, up from $100.8 billion in 2023. The system posted operating expenses of $115.2 billion, up from $100.5 billion in 2023. 
    • “The system posted a net income of $12.9 billion in 2024. Standard accounting rules required Kaiser and Risant to report the net value of unrestricted assets of the organizations that became part of Risant as one-time net income on its financial statements. A total of $6.8 billion of the $12.9 billion in the system’s net income was related to those acquisitions. The system posted a net income of $4.1 billion in 2023. 
    • “Kaiser reported capital spending of $3.7 billion in 2024, down from $3.8 billion in 2023. Its capital spending priorities in 2024 included preparations to meet California’s seismic safety standards by 2030 and supporting investments in leading-edge technologies and environmentally sustainable facilities. As of Dec. 31, Kaiser and Risant had 55 hospitals, 841 medical offices and 40 retail and employee clinics. “
  • Healthcare Dive reports,
    • “Verily, the life sciences arm of technology giant Alphabet, has reached a deal to sell its insurance subsidiary to Elevance, the payer confirmed to Healthcare Dive on Friday.
    • “The subsidiary, called Granular Insurance Company, provides stop-loss insurance for employers meant to protect them from catastrophically high medical costs.
    • “Terms of the deal were not disclosed.”
  • and
    • “A federal bankruptcy judge agreed to a deal on Thursday that places Prospect Medical’s struggling health system Crozer Health into a 30-day receivership.
    • “Under the terms, Pennsylvania regulators will provide Washington, D.C.-based FTI Consulting $20 million to act as an independent monitor and manager of Crozer while Prospect continues to search for a permanent buyer for the four-hospital health system.
    • “The deal isn’t the one Prospect originally intended to present before the Texas court. However, it will keep the lights on at Crozer for at least another 30 days.”
  • BioPharma Dive notes,
    • “Alumis and Acelyrin are merging, the biotechnology companies said Thursday afternoon, in an all-stock deal that leaves the combined company with a bigger cash balance and three drugs in clinical testing. 
    • “Per deal terms, Acelryin stockholders will receive 0.4274 shares of Alumis stock for each share they own, leaving them with about 45% of the combined company and Alumis equity holders with 55%. The new company, which will keep the Alumis name and be run by its executive team, would have $737 million in cash, enough to keep operating into 2027.  
    • “The merged entity will continue to develop Alumis’ two so-called TYK2 inhibitors, one of which is being developed for plaque psoriasis and lupus while the other is targeting neuroinflammatory conditions like multiple sclerosis. Acelyrin’s top prospect, a thyroid eye disease drug called lonigutamab, is part of the deal, too, but the program will be re-evaluated to “confirm its differentiation in a capital efficient manner,” the companies said.”

Monday report

David Ermer–Generative AI, Medical / Rx research, Mental health care, NIH, Obesity, OPM, SDOH, U.S. Healthcare–
Thanks to Justin Casey for sharing their work on Unsplash.

From Washington, DC

  • Per a press release,
    • “OPM joins the nation in mourning the passing of President Jimmy Carter. President Carter showed that public service isn’t just a line of work – it is life’s calling. From a young naval officer to a political leader, to leading as a humanitarian building homes and curing diseases, President Carter answered the call to public service. He set an example for every American to give back to their communities. He will truly be missed.” 
  • The Washington Post reports,
    • Memorial services for former president Jimmy Carter are expected to span several days and include public events in Atlanta and Washington.
    • Carter’s state funeral will be held Jan. 9 at 10 a.m. inside Washington National Cathedral after a procession from Georgia and a ceremony in which his body will lie in state in the U.S. Capitol, according to a news release from the Joint Task Force-National Capital Region.
    • “The 39th president will then be buried in a private ceremony in his hometown, Plains, Georgia.”
  • Govexec adds,
    • “President Biden issued an executive order on Monday to close federal agencies and offices next month in recognition of former President Jimmy Carter, who died Sunday at 100 in his home in Plains, Georgia.”
    • In accompanying guidance, Office of Personnel Management acting Director Rob Shriver said all federal employees would be excused from duty Jan. 9 “except those who, in the judgment of the head of the agency, cannot be excused for reasons of national security, defense, or other essential public business.” 
    • The day off applies to federal employees nationwide and will be treated like a holiday for purposes of pay and leave, the memorandum said.  

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “When President Jimmy Carter was diagnosed in 2015 with cancer in his liver and brain, he said that he would like to see the last Guinea worm die before he did.
    • “That just about came true.
    • “There were 3.5 million cases of the parasitic worm disease in 1986, when the 39th U.S. president took up the cause of eradicating it. In 2023, there were 14 human cases, and 11 from January through early December 2024, according to a provisional count.
    • “We’re not there yet, but thanks to him we’re very close,” said Dr. Donald R. Hopkins, former vice president of health programs and now special adviser on Guinea worm eradication to the Carter Center, the human-rights nonprofit the former president founded in 1982 with his wife, Rosalynn Carter.”
  • The Washington Post reports,
    • “Cases of the illness known as norovirus — which induces miserable bouts of vomiting and diarrhea — are surging across the United States, according to the Centers for Disease Control and Prevention. Ninety-one outbreaks of the gastrointestinal bug were reported the week of Dec. 5, the latest period for which data is available. That’s 22 more outbreaks than in the last week of November.
    • “While sometimes referred to as the stomach flu, the disease is not caused by the influenza virus, which results in respiratory illness.
    • “There are about 2,500 reported outbreaks each year in the United States, happening most frequently between November and April. When new strains of norovirus emerge, case counts usually rise, according to disease trackers.
    • “This year, the number of reported norovirus outbreaks have exceeded the numbers that we’ve seen recently and in the years before the pandemic,” according to the CDC.”
    • The article delves into signs and symptoms, treatment options, etc.
  • The American Medical Association tells us what doctors wish their patients knew about depression.
  • Neurology Advisor adds, “One in 6 women experienced symptoms of postpartum depression 2 months after cesarean delivery, according to study findings published in the American Journal of Obstetrics and Gynecology.“
  • The Wall Street Journal tells us about a 24 year old man who is trying to “outrun” schizophrenia.
    • “For the past four years, Kevin has been part of a living experiment. Shortly after he began hallucinating, during his junior year at Syracuse University, his doctors recommended him for an intensive, government-funded program called OnTrackNY. It provided him with therapy, family counseling, vocational and educational assistance, medication management and a 24-hour hotline.
    • “Such programs — there are around 350 in the United States — challenge the old idea that psychotic disorders are degenerative, a long slide to permanent disability. They operate on the notion of a golden hour. By wrapping a young person in social supports early on, the theory goes, it may be possible to prevent the disorder from advancing.” * * *
    • “But now, after four years, his time in the program was up. An estimated 100,000 people experience a first episode of psychosis every year, roughly four times the number of spots available in early intervention programs. So in December, it would all go away: the team of five providers and the hotline and the therapist who reminded him of his mother.
    • “What would happen to him without their support? Even as enthusiasm for early intervention builds, long-term studies are casting doubt on whether its benefits last after discharge. For Kevin, leaving the program meant a sudden blast of autonomy and a million questions about what his future, with schizophrenia, would look like.
    • “The training wheels are coming off,” he said.”
  • Per MedPage Today,
    • “There was “low but improving uptake” of reporting about the diversity of participants in summary documents for FDA-cleared pulse oximeters after voluntary guidance was issued in 2013, an analysis of public FDA records found.” * * *
    • “The most important finding is that although there were more mentions of skin color descriptors in performance testing after the FDA’s guidance, a majority of the public clearance documents for pulse oximeters did not include any mention of testing in diverse individuals,” Ferryman told MedPage Today in an email.
    • “Clinicians who work in hospital settings often do not get to choose which pulse oximeter device they use with their patients,” Ferryman said. “Because this research is based on the public record, it suggests that even if clinicians wanted to do their own research on the performance of pulse oximeters across diverse populations, the majority of FDA-cleared device records do not include any information about testing in different skin tones.”
    • Pulse oximeter readings in patients with darker skin tones tend to overestimate oxygen saturation, a long-standing issue described in multiple studies and discussed by an FDA advisory committee. * * *
    • “Newer FDA guidance on pulse oximeter testing that’s under development may correct some of these problems, but no single change in guidance “is likely to be sufficient to fully correct the problems of development, marketing, and dissemination of fully equitable pulse oximeters,” the [researchers] wrote.”
  • Per National Institutes of Health press releases,
    • “A study of nearly 10,000 adolescents funded by the National Institutes of Health (NIH has identified distinct differences in the brain structures of those who used substances before age 15 compared to those who did not. Many of these structural brain differences appeared to exist in childhood before any substance use, suggesting they may play a role in the risk of substance use initiation later in life, in tandem with genetic, environmental, and other neurological factors.
    • “This adds to some emerging evidence that an individual’s brain structure, alongside their unique genetics, environmental exposures, and interactions among these factors, may impact their level of risk and resilience for substance use and addiction,” said Nora Volkow M.D., director of NIDA. “Understanding the complex interplay between the factors that contribute and that protect against drug use is crucial for informing effective prevention interventions and providing support for those who may be most vulnerable.”
    • “Among the 3,460 adolescents who initiated substances before age 15, most (90.2%) reported trying alcohol, with considerable overlap with nicotine and/or cannabis use; 61.5% and 52.4% of kids initiating nicotine and cannabis, respectively, also reported initiating alcohol. Substance initiation was associated with a variety of brain-wide (global) as well as more regional structural differences primarily involving the cortex, some of which were substance-specific. While these data could someday help inform clinical prevention strategies, the researchers emphasize that brain structure alone cannot predict substance use during adolescence, and that these data should not be used as a diagnostic tool.”
  • and
    • “Among people with dialysis-dependent kidney failure, a form of psychological therapy called pain coping skills training reduced how much pain got in the way of their daily lives, also known as pain interference. The clinical trial, funded by the National Institutes of Health (NIH), found that training people on how to manage pain reduced the extent to which pain affected their work and social activities, mood, and relationships. The pain coping skills training, which was adapted for people undergoing long-term dialysis, also improved other effects of pain, including the intensity of pain, depression, anxiety, and quality of life. Pain coping skills training is an approach widely used for chronic pain, but it had not previously been tested for people treated with dialysis.
    • “Very few interventions have been shown to improve the quality of life for people with end-stage kidney disease being treated with dialysis,” said Dr. Paul Kimmel, program director at NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which led the study. “For example, opioids, which have been a main treatment for pain in this population, have side effects that can be more pronounced in the presence of kidney failure, making pain management challenging.” * * *
    • “The study results indicate that pain coping skills training may be an appealing alternative or complement to pain medications. Although the effect of the pain coping skills training on the overall cohort was modest, its high acceptability, tolerability, and safety and its observed benefits to pain, anxiety, depression, and quality of life support further research on developing nonpharmacologic, non-invasive strategies for managing pain in dialysis populations.
    • “Future work will focus on how to prolong the favorable effects of pain coping skills training and how to broadly implement this intervention in clinical practice,” said lead author Dr. Laura M. Dember, nephrologist and clinical investigator at the University of Pennsylvania Perelman School of Medicine, Philadelphia. “Based on the successful results of this study, our hope is that this intervention can be made available broadly to patients receiving dialysis.”
  • The Wall Street Journal offers a quiz about the FDA’s latest guidance on whether a particular food is healthy. For what it’s worth, the FEHBlog scored 100.

From the U.S. healthcare business front,

  • Fierce Pharma offers a “2025 forecast: After Novo, Lilly expansion sprees, ‘positive signals’ emerge around future supply of GLP-1 drugs.”
  • The Washington Post informs us,
    • “They don’t get fruitcakes or Christmas cards from grateful patients, but for decades robots have been helping doctors perform gallbladder removals, hysterectomies, hernia repairs, prostate surgeries and more. While patients lie unconscious on the operating table, robotic arms and grippers work on their bodies at certain stages in these procedures ― all guided by doctors using joystick-like controllers, a process that minimizes human hand tremor.
    • “Now, a team of Johns Hopkins University and Stanford University researchers has reported a significant advance, training robots with videos to perform surgical tasks with the skill of human doctors.
    • “The robots learned to manipulate needles, tie knots and suture wounds on their own. Moreover, the trained robots went beyond mere imitation, correcting their own slip-ups without being told ― for example, picking up a dropped needle. Scientists have already begun the next stage of work: combining all of the different skills in full surgeries performed on animal cadavers.
    • “A new generation of more autonomous robots holds the potential to help address a serious shortage of surgeons in the United States, the researchers said.
  • Check this out!
    • “As 2025 nears, healthcare is undergoing unprecedented transformation, particularly with headlines about artificial intelligence (AI) technologies shifting away from grandiose promises as the dust starts to settle around the potential of Generative AI (GenAI). These innovations and others aim to reshape how healthcare is delivered. 
    • “To shed light on anticipated trends, challenges and opportunities in healthcare technology in 2025, leading experts from Wolters Kluwer Health offer their outlook on 2025 across a variety of topics. Diffusing the hype, the predictions offer an eye-opening look at what’s ahead and lead us toward a smarter, more resilient future in healthcare technology.” 

Monday Report

David Ermer–Congress, FDA, Medical / Rx research, Medicare, Rx coverage, SDOH, U.S. Healthcare–
  • The Wall Street Journal reports,
    • “The all-out pursuit of the criminal suspect who gripped the public’s imagination for nearly a week ended on Monday at a McDonald’s in central Pennsylvania, about a half mile from the Greyhound bus station in a nondescript part of this town.
    • “A worker there noticed something familiar about a lone customer on Monday morning and called the local police. Soon 26-year-old Luigi Mangione, the subject of a massive manhunt and the man police suspect murdered UnitedHealthcare Chief Executive Brian Thompson in Manhattan last week in a targeted killing, was in custody.
    • ‘When, at last, he was unmasked—and unhooded—the mystery man at the heart of the brazen and apparently carefully plotted attack was even more of a riddle than expected. Held up as folk hero by some for striking a blow against America’s health insurers, he turned out to be a high-achieving product of elite schools, an affluent Ivy Leaguer who harbored anti-capitalist leanings that may have played a role.
    • “A review of his reading diet suggested that, at some point, his ideas about activism had crossed into an interest in violence. In January he wrote a chilling review on the Goodreads book-review site of Theodore John Kaczynski’s “Industrial Society and Its Future,” also known as “The Unabomber Manifesto.” He gave it four stars. 
    • “In Mangione’s review, he wrote: “A take I found online that I think is interesting”:
    • “Had the balls to recognize that peaceful protest has gotten us absolutely nowhere and at the end of the day, he’s probably right…. When all other forms of communication fail, violence is necessary to survive. You may not like his methods, but to see things from his perspective, it’s not terrorism, it’s war and revolution.”
  • The New York Times adds,
    • “Luigi Mangione will most likely be transferred to a Pennsylvania state correctional facility this evening, according to Gov. Josh Shapiro. Mangione faces two felony charges related to a firearm and false ID, and three misdemeanors — two relating to possession and use of a false ID and one relating to possession of an instrument of a crime.”
  • Per Beckers Hospital Review, United Health Group CEO Andrew Witty, whom Modern Healthcare named as the most influential person on U.S. healthcare, remarked to employees last Friday:
    • “I’m sure everybody has been disturbed by the negative and in many cases vitriolic media and commentary that has been produced over the last few days, particularly in the social media environment,” Mr. Witty said. “There are very few people in the history of the U.S. healthcare industry who had a bigger positive effect on American healthcare than Brian.”
    • “Our role is a critical role, and we make sure that care is safe, appropriate and is delivered when people need it,” he said. “We guard against the pressures that exist for unsafe care or for unnecessary care to be delivered in a way which makes the whole system too complex and ultimately unsustainable.”
  • Healthcare Dive reminds us that “Hospitals seek to prevent, mitigate attacks on clinical staff. After attacks on healthcare workers soared during the COVID-19 pandemic, providers have scrambled to address heightened violence in their workplaces.”

From Washington, DC,

  • STAT News reports,
    • “Legislation to restrict U.S. drugmakers from using key Chinese contract manufacturers was dealt a major blow when senators left it out of a must-pass defense budget bill this weekend.
    • “The BIOSECURE Act would prohibit pharmaceutical and biotechnology companies from using services or equipment from Chinese “companies of concern,” including WuXi AppTec and WuXi Biologics, in work that is contracted or funded by the U.S. federal government. Industry has come to rely heavily on those companies for contract manufacturing and other important services. Without the WuXi companies, costs for those services would go up.”  
  • Politico adds,
    • “It’s crunch time for Democrats and Republicans to come to a deal on a health care package to attach to government funding.
    • “The soft deadline for releasing bill text for a stopgap funding patch is usually the Sunday before the deadline. That means it would have to be out by Dec. 15 ahead of the Dec. 20 deadline. House Speaker Mike Johnson has targeted this week to release the legislation, leaving little time for lawmakers to agree on a health care package.
    • “Several other issues must still be resolved, including disaster-aid spending, which could complicate efforts on health care provisions.
    • “The state of play: Republicans and Democrats exchanged offers last week on a health care package. They aren’t far apart on some issues that might be easier to resolve — extending telehealth and hospital-at-home care rules and averting doctor pay cuts — but have significant differences to reconcile, including how to pay for it.
    • “Democrats propose regulations for pharmacy benefit managers — companies that negotiate drug prices for insurers or employers — that go beyond Republicans’ offer. Republicans propose repealing a Biden-era rule to increase nursing home staffing, a move they had already planned for next year. Democrats are also pushing to extend enhanced Affordable Care Act plan subsidies, but it’s not necessarily a line in the sand.
    • “Other issues being discussed include a potential compromise on legislation aimed at cracking down on Chinese biotechs. That didn’t hitch a ride on a negotiated version of a must-pass defense policy bill, the National Defense Authorization Act, released Saturday.
    • “If both sides agree to negotiate in good faith, a deal shouldn’t be that far away — in theory, at least. Republicans could have incentive to walk away when they will gain full control of Washington in weeks, while Democrats could force Republicans to come to a deal with a slim House majority next Congress.”
  • The American Hospital Association News tells us,
    • The AHA Dec. 9 said it supports a potential Medicare $2 Drug List Model, where people enrolled in a Part D plan would have access to certain prescription drugs for a low, fixed copayment no higher than $2 for a month’s supply per drug.  
    • “Providing low, fixed copayments for common generic drugs, as CMS proposed, could help increase medication adherence and improve health outcomes,” AHA wrote. “This model would standardize cost sharing for certain drugs for beneficiaries with Medicare Part D enrolled in a participating plan and their health care providers.” 
    • The AHA provided recommendations for how to account for shortages in the approved drug list and for public rulemaking to update the drug list annually, as well as feedback on potential quality measures for the model. Additional details on the request for information can be found on the M2DL webpage.

From the public health and medical research front,

  • The American Medical Association lets us know “what doctors wish patients knew about endometriosis.”
  • BioPharma Dive adds in a Deep Dive, “Endometriosis drug research, long underfunded, confronts familiar problems in women’s health. Up to 10% of women globally have endometriosis, yet the often-misunderstood disease largely remains off of drugmakers’ radar screens.”
  • Consumer Reports, writing in the Washington Post, reflects, “Meds like Wegovy are all over the news. But are they right for you, especially if you’re older than the average user?”
  • Per a press release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of suzetrigine (Vertex Pharmaceuticals) for the treatment of acute pain. 
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.” * * *
    • “The Evidence Report will be the subject of a virtual public meeting of the Midwest CEPAC on February 28, 2025. During the meeting, the independent council will vote on key questions raised in the report. Registration for the virtual public meeting is now open.“
  • The Wall Street Journal relates,
    • “GSK’s blood-cancer drug Blenrep showed positive overall survival data in a late-stage trial, increasing the likelihood for the treatment to return to market next year.
    • “The data showed that Blenrep, in combination with other drugs, reduced the risk of death by 42% in patients with multiple myeloma whose first treatment didn’t work or who had severe side effects, compared with Johnson & Johnson’s Darzalex, the British pharma giant said Monday.
    • “This represents a survival improvement of nearly three years compared with Darzalex combinations, supporting the potential for Blenrep combinations to become the new standard of care, GSK said.
    • “The U.S. Food and Drug Administration’s approval of Blenrep is expected on July 23, marking a comeback for the treatment in the U.S. In November 2022, the company withdrew the treatment after a trial revealed that Blenrep, then used alone, didn’t outperform an existing treatment.”
  • STAT News reports from the American Society of Hematology’s conference being held in San Diego
    • “From STAT’s Andrew Joseph: AbbVie said this morning that its drug tavapadon succeeded in another Phase 3 study in Parkinson’s disease, helping improve patients’ symptoms and quality of life.
    • “The TEMPO-2 trial tested flexible doses of tavapadon, ranging from 5 to 15 milligrams a day, in patients with early Parkinson’s. The study met its primary endpoint, with patients on the drug showing a greater improvement after 26 weeks on a scale that measures symptoms and quality of life versus those on placebo. Specifically, patients on the study drug had an improvement of 10.3 points on the scale, known as MDS-UPDRS, while those on placebo saw a 1.2-point worsening, a statistically significant difference.
    • “Tavapadon, a daily pill, works by partially activating the D1 and D5 dopamine receptors. In addition to the new flexible-dosing trial, the drug has also had positive Phase 3 trials when tested only at a high dose and when tested in combination with common dopamine therapy.
    • “AbbVie plans to submit tavapadon to the FDA next year. It acquired the drug through its purchase of Cerevel Therapeutics, a deal whose centerpiece was an experimental schizophrenia drug called emraclidine. Last month, however, AbbVie reported that emraclidine failed in two studies.”
  • and
    • “Johnson & Johnson and Genmab’s multiple myeloma drug Darzalex reduced the risk of disease progression by 51% among people with the pre-symptomatic, or “smoldering,” form of the disease, when compared with those who were only actively monitored for progression, according to new data presented at ASH on Monday.
    • “There are no approved treatments for smoldering multiple myeloma; patients are typically checked regularly through blood tests and other assessments. In a trial called AQUILA, J&J enrolled 390 people with smoldering myeloma at high risk of progression and randomized about half to receive Darzalex, with the others only monitored for progression. Patients were then evaluated for a median of nearly five and a half years.
    • “After five years, 63% of trial participants treated with Darzalex were alive and hadn’t progressed, compared to 41% of those who were actively monitored. Of those receiving Darzalex, 93% were still alive after five years, versus 87% of those in the control group. J&J has already asked regulators in the U.S. and Europe to approve Darzalex for smoldering multiple myeloma.
  • and
    • “Patients from disadvantaged neighborhoods were 33% less likely to receive a lifesaving bone marrow transplant, and faced a higher risk of death without one, new research from Fred Hutchinson Cancer Center that was presented at ASH shows. That said, survival rates post-transplant were consistent across socioeconomic groups.
    • “It really drills down on some of these social determinants of health as being access barriers for patients,” Jeff Auletta, the health equity chief at the National Marrow Donor Program, who was not involved in the study, told STAT.”
  • BioPharma Dive informs us,
    • “One year on from the landmark U.S. approval of two powerfully effective gene therapies for sickle cell disease, the treatments have been barely used, a sluggish start that reflects the myriad challenges of launching them.
    • “While some five-dozen people with the blood disorder have begun the treatment process for one or the other therapy, only two had actually received an infusion through mid-November, according to the therapies’ developers, Vertex Pharmaceuticals and Bluebird bio. That’s because the process typically lasts at least several months, involving a precise choreography of medical consultations, preparatory treatments and bespoke manufacturing of the two personalized therapies, called Casgevy and Lyfgenia.” * * *
    • “Some 100,000 people in the U.S. are estimated to have sickle cell. Vertex and Bluebird believe somewhere between one-sixth and one-fifth of that total population may be eligible for Casgevy and Lyfgenia, but only a slice will likely seek them out in the first few years.
    • “[Dr. Martin] Steinberg, [a hematologist] at Boston Medical Center, believes the current gene therapies will remain something of a niche product for the time being. “As we get more skillful at getting patients through the process, that won’t be as much of a stumbling block. Maybe we will be able to do one a month or so [at Boston Medical Center],” he said. “But it’s still too early for us to know if this is going to be realistic.”

From the U.S. healthcare business front,

  • Kaufmann Hall released its October 2024 National Hospital Flash Report. Here are the key takeaways:
    • “Overall, October data show continued stability. Revenue, average length of stay, and other indicators show stable performance.
    • “Outpatient revenue continues to grow. Revenue growth has been steady over the past few years, indicating a shift in how patients seek care.
    • “Discharges per calendar day increased compared to the previous month. This has led to a decrease in overall expenses on a volume adjusted basis, though supplies and drug expenses continue to grow.”
  • Beckers Hospital Review points out “ten health systems that recently had their outlooks upgraded by Fitch Ratings or Moody’s Investors Service.”
  • ALM Think Advisor explains why “Drug Cost Planning Is About More Than Choosing Plans.”
    • “Smart clients who want good benefits likely are paying higher premiums.
    • “One subtle short-term threat: skimpier coverage.
    • “A long-term concern: the fate of the new $2,000 annual out-of-pocket spending cap.”
  • MedTech Dive tells us,
    • “ECRI placed artificial intelligence-enabled applications at the top of its list of health technology hazards in 2025.
    • “ECRI, which released the list last week, said biases in the AI training data “can lead to disparate health outcomes or inappropriate responses,” adding that the technology can provide false or misleading outputs. The issues led the patient safety group to warn that putting too much trust in AI can result in inappropriate care decisions. 
    • “Other top health technology hazards for 2025 include the unmet technology support needs of home care patients, cybersecurity threats and substandard or fraudulent medical devices.”

Midweek Update

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

From Washington, DC

  • CBS News lets us know,
    • “The Biden administration says it has invoked the wartime powers of the Defense Production Act to speed rebuilding of a major American factory of intravenous fluids that was wrecked by Hurricane Helene last month. Damage to the plant in North Carolina has worsened a nationwide shortage of IV fluids, and hospitals say they are still postponing some surgeries and other procedures as a result. 
    • “Some 60% of the nation’s IV supplies had relied on production from the plant, run by medical supplier Baxter, before it was damaged by the storm.”
  • CMS released its “Final 2026 Actuarial Value Calculator Methodology.”
  • CMS announced,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), approved section 1115 demonstration amendments that allow, for the first time ever, Medicaid and Children’s Health Insurance Program (CHIP) coverage of traditional health care practices provided by Indian Health Service (IHS) facilities, Tribal facilities, and urban Indian organizations (UIO). Today’s action is expected to improve access to culturally appropriate health care and improve the quality of care and health outcomes for tribal communities in Arizona, California, New Mexico, and Oregon, and will support IHS, Tribal, and UIO facilities in serving their patients. 
    • “Traditional health care practices have been a way of life in many communities. And they are extremely important for American Indian and Alaska Native populations,” said HHS Secretary Xavier Becerra. “But, too often, health insurance does not cover them. With Medicaid and CHIP’s inclusion of traditional health care practices at certain IHS facilities, we are extending access to culturally appropriate, quality health care in Tribal communities.”
  • The Wall Street Journal reports,
    • “Novavax said federal regulators put a clinical hold on its application for a combination Covid-19 and influenza vaccine and stand-alone flu inoculation, sending shares down sharply.
    • “The vaccine maker on Wednesday said the Food and Drug Administration placed the hold because of a report of a “serious adverse event” of motor neuropathy in one clinical-trial participant outside the U.S., who received the vaccine in January of 2023.
    • “This participant was part of a Phase 2 trial for the combination vaccine that was completed in July 2023 and reported the adverse event in September of this year, the Gaithersburg, Md., company said.
    • “While we do not believe causality has been established for this serious adverse event, we are committed to working expeditiously to fulfill requests for more information from the FDA,” Novavax Chief Medical Officer Robert Walker said. “Our goal is to successfully resolve this matter and to start our Phase 3 trial as soon as possible.”
  • Reg Jones, writing in FedWeek, explains how court orders can impact federal retirement benefits.

From the public health and medical research front,

  • The Wall Street Journal tells us
    • “Frozen shoulder, a painful condition that immobilizes the shoulder joint, tends to strike midlife women.
    • “Treatments for frozen shoulder include steroid injections and physical therapy.
    • “Preliminary data suggests that hormone therapy might help prevent frozen shoulder in midlife women.”
  • and
    • “Scientists hope body tissues grown in labs will become a familiar sight in medicine. 
    • “Researchers around the world are working to grow heart valves, lungs and more from human cells. They have succeeded in bringing some to market such as knee cartilage and skin grafts, but advances for more complicated anatomy have been slow-going for years. 
    • “Now scientists are gaining ground in tissue engineering that could help a host of people who deal with circulatory-system problems.”
  • The American Medical Association offers “four steps to care for patients with prolonged symptoms of Lyme disease.”
  • BioPharma Dive notes,
    • “The Food and Drug Administration on Tuesday approved a new device to treat non-small cell lung cancer, Novocure’s Optune Lua, which creates electric fields that its manufacturer says disrupts malignant cell division. The FDA cleared the device for use with immunotherapy or chemotherapy in people whose cancer has spread and progressed following chemo.
    • “Approval was based on results from “Lunar,” a Phase 3 trial in which people who used the device with standard therapies had a 26% reduced risk of death over a median follow up of around 10 months. The results were controversial, however, because the trial included concurrent care with immunotherapies, which are typically used as a first-line treatment, as well as chemo.”
  • Per MedPage Today,
    • The long-term risk of distant recurrence for women with early breast cancer has declined significantly, a decades-long analysis of clinical trial data showed, largely a result of patients enrolling with lower-risk disease along with improved adjuvant therapy.
  • KFF discusses how “More Mobile Clinics Are Bringing Long-Acting Birth Control to Rural Areas.”
  • Per Health Day,
    • “Most Americans 50 and older don’t place much trust in health advice generated by artificial intelligence, a new survey finds.
    • “About 74% of middle-aged and senior Americans would have very little to no trust in health info generated by AI, the University of Michigan poll found.
    • “At the same time, these older adults have a lot of confidence in their ability to suss out bad info about health matters.
    • “Only 20% said they had little to no confidence they could spot misinformation about a health topic if they came across it.
    • “Among all older adults who’d scanned the web recently for health info, only 32% said it’s very easy to find accurate advice.
    • “Amid this lack of trust, our findings also highlight the key role that health care providers and pharmacists play as trusted health messengers in older adults’ lives, and even the role that friends or family with medical backgrounds can play,” said poll director Dr. Jeffrey Kullgren, an associate professor of internal medicine at the University of Michigan.”

From the U.S. healthcare business front,

  • Fierce Healthcare alerts us that U.S. News and World Report has released its Medicare Advantage and Part D plan ratings.
  • Beckers Hospital Review reports,
    • “UnitedHealth Group is seeing “unusually aggressive and high unit cost asks” from hospitals, CEO Andrew Witty said. 
    • “On an Oct. 15 call with investors, Mr. Witty said UnitedHealth wants to find a “new way of working with hospitals.” 
    • “We want to see less abrasion in the marketplace,” Mr. Witty said. “We believe that ought to come with more competitive rates in the marketplace.” 
    • “UnitedHealth reported its third-quarter earnings Oct. 15. CFO John Rex said medical costs rose in the third quarter, driven by increased pharmacy costs, Medicaid rates and an increase in coding intensity by hospitals.” * * *
    • “Mr. Witty told investors UnitedHealth wants to collaborate with hospitals to drive better value for the healthcare system. The company’s newly launched gold card program, which relaxes prior authorization requirements for some providers, is one example of this collaboration, Mr. Witty said. 
    • “The company is also seeking out partnerships with drug manufacturers to bring down prescription spending, Mr. Witty said. 
    • “Whether that be with drug companies that are interested in new ways of working to bring down costs, or whether that’s with hospital systems who want to work with us to reimagine what the patient experience, what the doctor experience is — [that’s] all part of bringing down the unit cost. Those are areas that are super important for the long run,” Mr. Witty said.” 
  • Per Fierce Pharma,
    • “With Gilead Sciences sprinting to a likely approval next year for its long-acting pre-exposure prophylaxis (PrEP) drug for HIV, the California company has a chance to one-up GSK. While the British company’s long-acting Apretude is injected every two months, Gilead’s answer is dosed just twice a year.
    • “Later this decade, GSK hopes to launch PrEP options that have four and six months of staying power. But, until then, it will do battle with Apretude (cabotegravir long-acting), which has just excelled in several real-world studies.
    • “In two real-world evidence studies of nearly 1,300 people, Apretude has shown better than 99% effectiveness in preventing HIV infections. GSK’s ViiV Healthcare unit also presented findings from the PILLAR implementation study, which show reductions in stigma and anxiety among users of the treatment. The new results are being presented Wednesday through Saturday in Los Angeles during IDWeek 2024.
    • “The results add to the positive momentum for Apretude, which was approved in December 2021 as the first long-acting PrEP option for HIV. The drug offers an alternative to daily pills such as Gilead’s Truvada and its follow-on Descovy.”
  • Investing.com relates,
    • “Aetna, a CVS Health company (NYSE: NYSE:CVS), has introduced a new health plan option called SimplePay Health, aimed at self-insured customers to potentially lower health care costs, enhance health outcomes, and streamline the health care experience. This plan offers a unique payment approach and tools for selecting high-quality health care providers.
    • “SimplePay Health, which is part of Aetna’s expanding portfolio, is designed to offer price certainty and simplicity for members. It features a copay-only structure with no deductibles or coinsurance, providing members with clear cost information for services prior to visits or treatments. The copay encompasses all aspects of a service, such as hospital visits or specialty services like labs.
    • “The plan claims to have resulted in a 60 percent increase in the use of top-quality providers and a 12 percent reduction in total care costs for employers and members. Members are equipped with an app to find providers based on cost and outcome quality, and they receive a single monthly statement summarizing all medical and pharmacy claims, similar to a credit card statement but with no interest and no payment due at the time of service.
    • “Aetna asserts that SimplePay Health enhances the overall health care experience by offering transparent cost insights and quality information to aid members in making informed decisions. Additionally, the plan includes a 0% interest rate line of credit benefit for paying balances, which is integrated into the medical plan.”

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, NIH, Obesity, SDOH, Telehealth–

From Washington, DC,

  • Govexec informs us,
    • “The Senate on Thursday made progress on advancing bipartisan spending bills for fiscal 2025, though members of both parties acknowledged significant divisions remain between the two sides. 
    • “The chamber’s Appropriations Committee approved three of the 12 annual funding measures Congress must pass each year—those funding the departments of Agriculture and Veterans Affairs, as well as the legislative branch—in unanimous, 27-0 votes. While that marked a significant step forward in the fiscal 2025 process and an accomplishment that has eluded the panel’s House counterpart—which has advanced its bills to date only along partisan lines—the Senate could not come to a bipartisan agreement on how much money to allocate for the remaining nine funding measures.”
  • and
    • “The Senate on Wednesday voted 55-37 to confirm Anne Wagner as the third member of the Federal Labor Relations Authority, finally bringing the agency’s political leadership to nearly full strength.
    • “Similar to the National Labor Relations Board’s role overseeing collective bargaining in the private sector, the FLRA governs labor-management relations at federal agencies, with a three-member board that settles unfair labor practice complaints and other disputes between unions and management.” * * *
    • “Federal employee unions rejoiced at the news that the FLRA’s board was now fully staffed. The last 18 months of deadlock between [Colleen Duffy] Kiko and FLRA Chairwoman Susan Tsui Grundmann has meant the board could only rule in noncontroversial cases.”
  • The American Hospital Association News lets us know,
    • “The Senate Committee on Health, Education, Labor and Pensions held a hearing July 11 on medical debt. The AHA submitted a statement for the hearing that highlighted how the quality of insurance coverage is a driver of medical debt, saying that coverage for many patients is either insufficient or unavailable. The AHA discussed hospital and health system efforts offering financial and other assistance, and that hospitals absorb billions of dollars in losses for patients who cannot pay their bills, mainly due to inadequate commercial insurance coverage. To address the issue, the AHA urged Congress to restrict the sale of high-deductible health plans to individuals with the ability to afford the associated cost-sharing; prohibit the sale of health-sharing ministry products and short-term limited-duration plans that go longer than 90 days; and lower the maximum out-of-pocket cost-sharing limits, among other changes.”
    • That’s nuts, and it’s worth adding that all of the witnesses, except for one, were from the creditor side. Here’s a link to the American Enterprise Institute testimony.
  • The AHA News adds,
    • “The Centers for Medicare & Medicaid Services July 10 announced there will be 133 participants representing 772 practices for its new Making Care Primary Model. Participants in this voluntary model are from Colorado, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Carolina and Washington. The model, which began July 1 and will run through 2034, seeks to improve care management and care coordination, enable primary care clinicians to partner with health care specialists, and use community-based connections to address patients’ health needs as well as their health-related social needs such as housing and nutrition.”
  • and
    • “The Centers for Medicare & Medicaid Services recently released results of an air ambulance qualifying payment amount calculations audit on Aetna Health in Texas. The report found that Aetna used practices that did not comply with federal requirements, and strongly recommended corrective actions. Specifically, the report found that Aetna failed to “properly calculate the QPA by using claim paid amounts instead of contracted rates, and counting each claim as its own contracted rate, even when the claims were for the same amounts for the same item or service and to the same provider of air ambulance services.” Aetna may also be subjected to future audits.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Research into chronic conditions affecting women is significantly lacking, and the National Institutes of Health and other agencies should do more to investigate issues that lead to worse medical treatment for women, a new report from the National Academies of Sciences, Engineering and Medicine says.
    • “Women are disproportionately affected by chronic illnesses, including Alzheimer’s disease and depression, according to the study requested by NIH’s Office of Research on Women’s Health and published Wednesday.
    • “But inadequate research in women’s health “hinders a comprehensive understanding of the impact on women” of these and other chronic illnesses, the report’s authors write. Further research is needed, particularly for Black women, who are more likely to die of a chronic illness than White women, the study says.”
  • and
    • “Nearly 1 in 10 people infected with the coronavirus during pregnancy developed long covid, according to a study published Thursday in the journal Obstetrics and Gynecology.
    • “Thursday’s study, which highlights the consequences of the virus during pregnancy, suggests long covid is more prevalent among people infected while pregnant than in the population overall. As many as 7 percent of Americans report having symptoms associated with long covid, according to a 2022 report from the Centers for Disease Control and Prevention. Some surveys suggest a far higher incidence of long covid in the general population.” * * *
    • “I was initially surprised at the prevalence of long covid in this population,” said Torri Metz, one of the study’s lead authors and a maternal-fetal medicine specialist at University of Utah Health. “It really drew my attention to the fact I need to have this on my radar when I am seeing patients.”
  • NBC News informs us,
    • “A key mystery behind one of the most common autoimmune diseases may finally have an answer.
    • “Researchers at Northwestern Medicine and Brigham and Women’s Hospital say they’ve discovered a root cause of lupus, a disease that affects hundreds of thousands of people in the U.S. 
    • “Scientists have long suspected that a person’s genetics or hormones may predispose them to lupus, and that the disease may be triggered by environmental factors like a previous viral infection or exposure to certain chemicals.
    • “Now, a study published Wednesday in the journal Nature outlines a clear pathway for how the disease likely develops, pointing to abnormalities in the immune systems of people with lupus.”
  • Neurology Advisor points out,
    • “The prevalence of stroke has increased by 14.6% from 2011 to 2022 among individuals aged 18 to 44 and 15.7% among those aged 65 and younger in the United States, according to a report published in Morbidity and Mortality Weekly Report.
    • “Researchers assessed trends in stroke prevalence between 2011 and 2022, using data from the Behavioral Risk Factor Surveillance System (BRFSS), a state-based surveillance system administered to noninstitutionalized civilian adults in the US in collaboration with the Centers for Disease Control and Prevention (CDC). * * *
    • “Age-standardized prevalence of stroke increased from 2.7% in 2011 to 2013 to 2.9% in 2020 to 2022, marking a 7.8% (95% CI, 4.9%-10.8%) increase in overall stroke prevalence. The researchers noted the highest stroke prevalence (7.7%; 95% CI, 7.5%-7.9%) among individuals aged 65 and older and the lowest prevalence (0.9%; 95% CI, 0.8%-1.0%) among individuals aged between 18 and 44 years.
    • “Stroke was observed to be highest (5.3%; 95% CI, 4.7%-5.9%) among the American Indian or Alaska Native group and lowest among the Asian group (1.6%; 95% CI, 1.2%-2.0%).
    • “With regard to educational level, individuals with a high-school diploma had the highest stroke prevalence (5.2%; 95% CI, 4.8%-5.4%) and those with a college degree or higher had the lowest stroke prevalence (1.7; 95% CI, 1.6%-1.8%).”
  • STAT News relates,
    • “Researchers from the American Cancer Society and International Agency for Research on Cancer estimate 40% of all cancer cases in the United States in people 30 and up were due to “potentially modifiable risk factors,” including cigarette smoking, physical inactivity, consumption of processed meat, viruses, excess body weight, alcohol drinking and more. Data was from 2019 in order to avoid the influence of the pandemic, when cancer diagnoses declined because of delayed care. The results were published in the American Cancer Society’s journal, CA: A Cancer Journal for Clinicians.” * * *
    • “In the study, alcohol was associated with seven cancers: oral cavity, pharynx, larynx, colorectum, and female breast, as well as squamous cell carcinoma in the esophagus, and hepatocellular carcinoma in the liver. Beyond those, “there is accumulating evidence” that alcohol can cause other cancers, such as pancreatic cancer, said lead author Farhad Islami, senior scientific director of cancer disparity research at ACS (which funded the study). 
    • “The increased risk is because of the alcohol in alcoholic beverages, not the type of beverage,” he said. A standard alcoholic beverage in the United States has about 14 grams of pure ethanol. That looks like one 12-ounce serving of 5% ABV beer, a 5-ounce serving of 12% ABV wine, 8-10 ounces of 7% ABV hard seltzer, or 1.5 ounces of 40% ABV liquor. Research suggests the higher a person’s consumption, the higher the risk of cancer.”
  • Here is a link to the NIH Director’s blog titled this week “Sequencing Technique Detects Earliest Signs of Genetic Mutations Underlying Cancer, Aging, and More”
  • The National Institutes of Health announced,
    • “Early findings from a small clinical trial provide evidence that a new cellular immunotherapy approach may be effective in treating metastatic solid tumors. In the trial, researchers from the National Institutes of Health (NIH) genetically engineered normal white blood cells, known as lymphocytes, from each patient to produce receptors that recognize and attack their specific cancer cells. These initial findings are from people with metastatic colorectal cancer who had already undergone multiple earlier treatments. The personalized immunotherapy shrank tumors in some patients and was able to keep the tumors from regrowing for up to seven months. The findings were published July 11, 2024, in Nature Medicine.” * * *
    • “Colon cancer is just one of many solid tumors the researchers are studying. The trial is still ongoing and includes patients with different types of solid cancers.
    • “It’s just the very beginning of converting normal lymphocytes into cells capable of treating the common solid cancers,” Dr. Steven A. Rosenberg, a co-leader of the study, said. “What this study shows is that it’s possible. Once you know it’s possible, you work to improve it.”
  • Here is a link to the All of Us Program’s latest Medical Minutes.

From the U.S. healthcare business front,

  • Beckers Hospital Review tells us,
    • “As more older adults opt for Medicare Advantage plans, reimbursement fights between hospitals and insurers are increasingly centered around those contracts.
    • “According to data shared with Becker’s by FTI Consulting, there were 20 reimbursement disputes between hospitals and insurers that made headlines somewhere in the country during the second quarter, the same amount as the first quarter and slightly lower than the same period in 2023, when 24 contract disputes were reported in national or local media.
    • “Notably, a record number of Q2 disputes (15 of 20) involved Medicare Advantage plans, and 30% of disputes failed to reach a timely agreement, meaning tens of thousands of patients were left without in-network coverage. FTI has tracked media reports regarding negotiations over reimbursement rates during each quarter since early 2022.”
  • BioPharma Dive reports,
    • “On Thursday, the pharmaceutical giant [Pfizer] said it is advancing a once-daily version of an experimental and closely watched medicine called danuglipron. Pfizer based the decision on results from a small clinical trial of healthy volunteers that’s been evaluating how the body interacts with danuglipron. Studies designed to find the optimal dose of the medicine are scheduled for later this year.
    • “Umer Raffat, an analyst at the investment firm Evercore ISI, speculates that with its update Thursday, Pfizer is “likely buying time” to see more data from a backup once-daily drug it’s been developing. “Candidly, the trial that just wrapped up never answered the question on” what dose would be effective enough to compete, he wrote in a note to clients.
    • “In that backdrop, the judicious thing to do from [the] Pfizer perspective was to not overcommit — and that’s exactly what they did today,” Raffat added. They “didn’t kill [danuglipron], they said it may move forward, but not right to [Phase 3].”
  • Beckers Payer Issues adds,
    • “As insurers continue to face major financial pressures related to covering weight loss drugs, many are steering more patients toward bariatric surgery to achieve similar results.
    • “Insurance companies are seeing that they’re getting more reliable outcomes and savings in the long run if they pay for someone to have bariatric surgery,” Christine Ren Fielding, MD, told Becker’s. Dr. Ren Fielding is a professor of surgery at NYU School of Medicine, the director of the NYU Langone Weight Management Program and chief of the system’s division of bariatric surgery.
    • “If you’re a responder to appetite control caused by a GLP-1, then there’s another treatment option that will do exactly the same thing: bariatric surgery. That includes Lap-Band, sleeve gastrectomy, and gastric bypass,” she said. “Bariatric surgery is the old-fashioned way. Insurers are now putting up barriers for people who want to be covered for GLP-1s and taking down barriers for people who want to have surgery.”
  • STAT News informs us,
    • “The Food and Drug Administration rejected Novo Nordisk’s weekly insulin for the treatment of diabetes in a rare setback for the pharmaceutical giant.
    • “The agency has requests related to the manufacturing process and the use of the insulin specifically in type 1 diabetes patients, Novo said in a statement Wednesday. The company, which had submitted an application for the drug for both type 1 and type 2 patients, said it does not expect to be able to fulfill the requests this year.”

Midweek Update

David Ermer–ACA, Congress, FDA, Federal employment benefits, Medical / Rx research, SDOH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • Beckers Payer Issues reports,
    • “Making expanded ACA subsidies permanent would add $335 billion to the national deficit between 2025 and 2034, the Congressional Budget Office estimated. 
    • “Premium tax credits have spurred record enrollment in ACA marketplace plans. These subsidies, implemented in 2021, are set to expire at the end of 2025 unless Congress votes to extend them. 
    • “In a June 24 letter to the chairs of the House ways and means and budget committees, the CBO estimated making subsidies permanent would cost $415 billion overall — the result of a $250 billion increase in spending and a $164 billion decrease in tax revenue. 
    • “These costs would partially be offset by a decline in offers of employment-based insurance, the CBO estimated, resulting in a total add of $335 billion to the budget.  * * *
    • “Payer executives have told investors they are optimistic Congress will cut a deal to extend the subsidies or make them permanent.”
  • Fierce Healthcare tells us,
    • “A leading Democrat and health legislator is urging the Centers for Medicare & Medicaid Services (CMS) to better enforce Medicare Part D program requirements for pharmacy benefit managers.
    • “By evading such requirements, PBMs are threatening the financial health of the country’s smaller pharmacies, Senate Finance Committee Chair Ron Wyden, D-Oregon, wrote to the agency in a letter (PDF).
    • “I am alarmed to hear reports that PBM contracting practices are straining the finances of pharmacies and directly contributing to their closures,” he said. “Specifically, I am concerned PBMs are not adhering to the new rule reining in direct and indirect remuneration (DIR) fees that took effect on January 1 and undermining Medicare’s pharmacy access standards as intended by Congress.”
  • The National Academies of Sciences, Engineering, and Medicine released a report titled “Ending Unequal Treatment: Strategies to Achieve Equitable Health Care and Optimal Health for All” which follows up on a well-known 2003 report on social determinants of health.
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies. Diversity Action Plans are intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product. * * *
    • “Comments on the draft guidance should be submitted within 90 days after publication in the Federal Register to Regulations.gov. All written comments should be identified with the docket number and with the title of the guidance document.”
  • Federal News Network informs us,
    • “For more than a week, federal employees enrolled in FSAFEDS have not been receiving payments for approved reimbursement claims made in their Flexible Spending Accounts.
    • “The program suspended all reimbursement payments beginning June 16 as an effort to further strengthen anti-fraud and security measures, Federal News Network confirmed with a government source who explained the issue on the condition of anonymity.
    • “At this time, the FSAFEDS is holding all claims payments out of an abundance of caution,” FSAFEDS wrote Tuesday in a post on X. “FSAFEDS has taken this action due to recently discovered fraudulent claims activity. We are working to resolve and restore all claims payment activities as soon as possible.”
    • “The pause on reimbursement payments, however, has been lifted and payments to employees should resume soon, Federal News Network has learned. FSAFEDS plans to process all reimbursements currently on hold by the end of the week.

From the public health and medical research front,

  • MedPage Today tells us,
    • “All adults ages 75 years and older should receive a single dose of any respiratory syncytial virus (RSV) vaccine, and adults ages 60 to 74 years who are at increased risk of severe RSV disease should receive a vaccine, according to a unanimous 11-0 vote by the CDC’s Advisory Committee on Immunization Practices (ACIP).
    • “Also, people who have already received the RSV vaccine are not recommended to receive a booster, based on data that showed another dose did not improve outcomes.
    • “These recommendations supplant the current recommendation that adults ages 60 and older may receive RSV vaccination after engaging in shared clinical decision-making with their healthcare provider.
    • “There are currently three RSV vaccines available for use in older adults — GSK’s adjuvanted RSV prefusion F protein-based vaccine (Arexvy) Pfizer’s unadjuvanted, bivalent RSV prefusion F protein vaccine (Abrysvo), and Moderna’s mRNA-1345 vaccine (mRESVIA).
  • The American Hospital Association News notes,
    • “The Administration for Strategic Preparedness and Response June 25 announced a flu pandemic preparedness and response strategy in response to the threat of H5N1 bird flu in humans. The strategy, released through ASPR’s Biomedical Advanced Research and Development Authority, has four objectives: strategic implementation and deployment of the national pre-pandemic influenza vaccine stockpile; enhanced protection through novel vaccines; leverage therapeutics through deployment, early availability and development of novel products; and ensure rapid and effective diagnostics tools to inform rapid antiviral prescription and treatment.” 
  • BioPharma Dive calls attention to the fact “Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help? There are no drugs specifically for polycystic ovary syndrome, a chronic condition that can cause infertility. One study is testing whether Wegovy might be beneficial.”
  • Per Fierce Pharma,
    • “[Verona Pharma’s] Ohtuvayre [which the FDA approved for marketing today] becomes the first novel treatment advance in more than a decade for COPD, an inflammatory condition which restricts airflow from the lungs and leaves patients struggling to breathe. Ohtuvayre is approved as an add-on medicine with current therapies.
    • “As a selective dual inhibitor of the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes, Ohtuvayre combines two properties in one medicine, setting it apart in COPD for its ability to both open the airways of patients and reduce their inflammation.
    • “It’s really the first novel mechanism as an inhaled therapy in over 20 years for COPD,” David Zaccardelli, Verona’s CEO said in an interview with Fierce Pharma. “We believe its bronchodilator and non-steroidal anti-inflammatory activity has the potential to change the treatment paradigm.”
  • The Washington Post reports,
    • “A few of your favorite ice cream products might no longer be in the freezer this summer after a prominent supplier to brands such as Hershey’s and Friendly’s issued a recall notice over a potential listeria contamination.
    • “Maryland-based Totally Cool recalled products from 13 brands distributed nationwide in retail locations and through direct delivery after sampling by the Food and Drug Administration discovered the presence of Listeria monocytogenes, the bacterium that causes listeria infections, the agency said Monday.
    • “The brands involved were Abilyn’s Frozen Bakery, Amafruits, Chipwich, Cumberland Farms, Dolcezza Gelato, Friendly’s, Hershey’s Ice Cream, Jeni’s, LaSalle, Marco, Taharka Brothers, the Frozen Farmer and Yelloh. More than 65 products were recalled, including ice cream cakes and sandwiches, as well as sorbets, according to a list published by the FDA that includes expiration dates.”

From the U.S. healthcare business front,

  • Kaufmann Hall discusses the state of play in healthcare antitrust enforcement.
  • The Wall Street Journal predicts “The War Over Cheaper Ozempic Won’t End Well for Some Investors. Once Eli Lilly and Novo Nordisk increase supply of weight-loss medications, companies such as Hims & Hers may find it trickier to sell compounded versions of the drugs [due to the nuances of FDA law.]”
  • MedTech Dive points out “Abbott and Dexcom are launching the first over-the-counter CGMs. Here are 7 questions on the new tech. Experts expect the release of new over-the-counter glucose monitors in the U.S. to fuel more widespread use of the devices.”
  • Per Fierce Healthcare,
    • “Blue Shield of California is making it easier for members to access their personal health data through its new Member Health Record.
    • “The platform will combine health data both from claims as well as from providers in one place and is available both online and through Blue Shield’s app so members can connect virtually. The Member Health Record will first launch for a “select group” of Medicare Advantage members and will be rolled out to all of its members by the end of the year.
    • “The health record will include information on lab results, immunizations, diagnoses and conditions alongside historical health data that have been shared with the plan, including details tallied before the member joined Blue Shield.”