Monday Roundup

FDA

Monday Roundup

David Ermer–ACA, COVID-19 testing, FDA, Generative AI, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Federal News Network tells us,
    • “Close to 15,000 blue-collar federal employees working in trade, craft and manual labor jobs are likely to see their federal pay rates increase by as much as 12%, once a new proposed rule from the Office of Personnel Management becomes finalized.
    • “The proposed regulations, which OPM released on Monday, aim to improve overall pay parity for roughly 168,000 blue-collar federal workers who are paid hourly through the Federal Wage System (FWS). In practice, OPM’s proposal would align the map of FWS wage areas more closely with the General Schedule’s locality pay map.
    • “This would lead to greater equity across federal pay systems, with FWS workers’ pay more aligned with GS workers who work in the same geographic area,” OPM wrote in a press release Monday.
    • ‘As a result of the proposed re-mapping, around 15,000 blue-collar federal employees would begin receiving higher pay rates once OPM’s regulations become final — as long as there are no major changes to how the proposed regulations are currently written.”
  • and
    • “The Postal Service, more than three years into a 10-year reform plan, is seeking a higher borrowing limit with the Treasury Department to sustain its infrastructure upgrades.
    • ‘USPS, in an update to its “Delivering for America” plan last week, said its current $15 billion debt limit with Treasury was set in the 1970s, and has not been adjusted for inflation in decades.
    • “We continue to lack access to capital and credit markets that most in the private sector rely on in transformative situations like ours,” USPS wrote in a report last week.
    • “USPS is also calling on the Office of Personnel Management to reassess what it pays into the Civil Service Retirement System, the pension system for federal employees who began government service before 1987.”
  • Gallagher timely reminds us about ACA FAQ 63 which told us
  • The American Hospital Association News informs us,
    • “AHA President and CEO Rick Pollack Oct. 7 sent a letter to President Biden urging the Administration to take immediate actions to increase the supply of IV solutions for hospitals and other health care providers that are struggling with shortages following the closure of a Baxter manufacturing plant as a result of Hurricane Helene.  
    • “Our members are already reporting substantial shortages of these lifesaving and life-supporting products,” Pollack wrote. “Patients across America are already feeling this impact, which will only deepen in the coming days and weeks unless much more is done to alleviate the situation and minimize the impact on patient care.”  
    • “The letter includes a number of specific actions the AHA is asking the Administration to take to support hospitals’ ability to care for patients and communities. In addition, the AHA invited the White House and agency experts to join the association in a forum to communicate directly with hospitals and health systems to “inform each other in real time on the status of the situation while we work together to mitigate the impact on patients.” 
  • Fierce Healthcare offers a summary of HHS’s proposed 2026 notice of benefit and payment parameters for the ACA marketplace. The public comment deadline is November 12, 2024.

From the Food and Drug Administration front,

  • Per an FDA press release,
    • “Today [October 7], the U.S. Food and Drug Administration granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. The test, authorized for use without a prescription, is for use by individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results in approximately 15 minutes for COVID-19 and influenza (flu). The test detects proteins from both SARS-CoV-2 (the virus that causes COVID-19) and influenza A and B (the viruses that causes flu).  
    • “This is the first over the counter (OTC) test that can detect influenza to be granted marketing authorization using a traditional premarket review pathway, which enables the test to be marketed in the absence of an applicable emergency use declaration. Other OTC flu/COVID tests are currently available under emergency use authorization.” 
  • Per MedTech Dive,
    • The Food and Drug Administration approved Exact Sciences’ Cologuard Plus colorectal cancer test, the company said Friday [October 4]. 
    • The product is an updated version of Exact Sciences’ existing stool-based cancer test. The company expects to launch the test, which has higher specificity than its predecessor, with Medicare coverage and guideline inclusion in 2025.
    • Exact Sciences recently failed to land a Medicare price premium for Cologuard Plus, but Leerink Partners and William Blair analysts expect one of the company’s subsequent attempts to succeed.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The Nobel Prize in medicine was awarded to Victor Ambros and Gary Ruvkun for the discovery of microRNA, molecules that help control how genes are expressed.
    • “Their findings unlocked new areas of research into the roles these molecules play in human health. Researchers are exploring microRNA treatments for cancer, heart disease and dementia.”
    • “Ruvkun and Ambros were giddy with excitement on Monday after learning of their Nobel honors.”
    • Kudos to the recipients.
  • and, on a different topic,
    • “Inflammaging, a chronic low-grade inflammation, is associated with an increased risk of heart attack, cancer, Alzheimer’s and other conditions. It occurs as we age, but some people develop it more than others.
    • “Chronic inflammation can be caused by cellular senescence, where damaged aging cells secrete inflammatory proteins. 
    • “Prevention and treatment measures include lifestyle changes such as exercise, healthy diet and adequate sleep.”
  • The American Medical Association lets us know eight things that doctors wish their patient knew about the flu vaccine.
  • Consumer Reports, writing in the Washington Post, fills us in on how to choose the right multivitamin for your body’s needs.
  • Per BioPharma Dive,
    • “An experimental, muscle-preserving therapy from Scholar Rock succeeded in a Phase 3 trial in spinal muscular atrophy, positioning the biotechnology company to seek approvals in the U.S. and Europe early next year.
    • “A regimen of Scholar Rock’s drug, apitegromab, and a standard SMA therapy significantly improved motor function after one year versus treatment with a typical SMA medicine and a placebo, the company said Monday. Specifically, a prespecified, pooled analysis showed children between 2 and 12 years old who received one of two tested doses had an average difference versus placebo of about a 1.8-point change from baseline on a scale used to evaluate their physical abilities.
    • “Motor function benefits were also observed in a smaller, exploratory group of 13- to 21-year-olds, according to the company. No new safety findings were reported, and no one dropped out of the trial due to side effects. “We believe these data collectively show that apitegromab has the potential to become part of a new standard of care,” CEO Jay Backstrom said on a conference call. Shares more than quadrupled in value Monday.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “The healthcare industry is making the push toward greater adoption of value-based care, yet it’s not a secret that progress has been slow-moving.
    • “With that backdrop, UnitedHealth Group has released its latest “A Path Forward” report, which is a biennial look at progress in the shift to value. The paper includes dozens of policy recommendations that the team believes can accelerate that transformation.
    • “Wyatt Decker, M.D., UnitedHealth Group executive vice president and chief physician who’s leading the charge at the company on value-based care and innovation, told Fierce Healthcare in an interview that the U.S. healthcare system is extremely effective at addressing crises, complex patient conditions and end-stage needs. But it’s in prevention where “we really fall down,” he said.
    • “We don’t, by and large, have a system that focuses on keeping people healthy and well,” Decker said. “Most people wonder why their physician or their assistants don’t reach out when it’s time to get a screening and why they have so much trouble scheduling appointments, finding doctors, and, of course, figuring out how much it’s all going to cost.” 
  • and
    • “GenAI experimentation, research and potential use cases proliferate by the day. Like other industries, healthcare is hurrying to jump on the opportunity. A growing number of companies are creating genAI products to help organizations streamline their administrative workflows, simplify physician notetaking or respond to basic patient questions. But publicly available tools, like ChatGPT, are popular, easy to access and simple to use. If consumers are using them, are doctors, too?
    • “The answer, Fierce Healthcare finds, is yes. In the first in-depth look of its kind into physician use of public genAI tools, Fierce Healthcare spoke with nearly two dozen doctors, students, AI experts and regulators, and helped conduct a survey of more than 100 physicians. The reporting confirms that some doctors are turning to tools intended for non-clinical uses to make clinical decisions. With no standardized guidelines, lagging physician training and regulators racing to try to keep up with rapidly changing technology, guardrails to protect patients appear to be years behind current rates of utilization.
    • “You have an uncertain regulatory environment, you’ve got a march of technology and at the same time, you have an uptake by both consumers and healthcare professionals. And the consequences of that are very much uncertain,” Peter Bonis, M.D., chief medical officer at Wolters Kluwer, an information services company, told Fierce Healthcare.”

  • The FEHBlog learned a new use for the work “hallucination” today at the Texas Bar Association’s Health Law Conference. A generative AI mistake is a hallucination.
  • McKinsey and Company discuss “Advancing inclusive care pathways for people with disabilities. Across disease types, patients with disabilities experience inequities all along the care pathway—with consequently worse outcomes. Inclusive pathway designs and targeted interventions could help.”

Thursday Miscellany

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

From Washington, DC

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

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday Roundup

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Medicare, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS), through the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (hereafter ASTP), today published the final 2024-2030 Federal Health IT Strategic Plan – PDF in accordance with the Health Information Technology for Economic and Clinical Health (HITECH Act.) The Strategic Plan presents federal health information technology (health IT) goals and objectives to achieve a future state where health IT and electronic health information are used to:
      • Promote health and wellness;
      • Enhance the delivery and experience of care;
      • Accelerate research and innovation; and
      • Connect the health system with health data.
    • “The draft Strategic Plan was published by ASTP in March 2024 following a comprehensive and collaborative effort with more than 25 federal agencies that are central to the advancement of health IT. These federal agencies regulate, purchase, develop, fund, research, and use health IT to improve patient care and health outcomes. The Strategic Plan was subsequently updated and finalized following a 60-day public comment period, which produced comments from a variety of organizations including health care systems, associations and specialty societies, electronic health record developers, patient advocates, and others.”
  • In related news, the Sequoia Project made the following announcement,
    • “TEFCA RCE Webinar on TEFCA Exchange for Public Health
    • “Friday, October 11 | 11:00 a.m. – 12:00 p.m. ET
      • “Access to health information is an important tool for Public Health Authorities (PHAs) and their Delegates to support core public health services including, but not limited to, assessing and monitoring population health and investigating, diagnosing, and addressing health hazards and root causes. Use cases described in the recently released Public Health Exchange Purposes Implementation SOP, allow PHAs to identify disease trends, track and monitor outbreaks, and prevent and control future outbreaks.
      • “Join experts from the Trusted Exchange Framework and Common Agreement™(TEFCA™) Recognized Coordinating Entity® (RCE™) and the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) for an informative webinar, where we’ll cover the essentials of TEFCA Exchange and dive into the details of the Public Health Exchange Purposes Implementation SOP.” * * *
      • “Don’t Miss Out – Register Now!
  • The American Hospital Association News lets us know,
    • “Johnson & Johnson Sept. 30 notified the Health Resources and Services Administration that it is ceasing implementation of its proposed 340B rebate model. The decision comes after HRSA Sept. 27 said it would terminate J&J’s Pharmaceutical Pricing Agreement and/or impose civil monetary penalties if J&J didn’t halt implementation of the program.” * * *
    • “The AHA is pleased that Johnson & Johnson has decided to cease implementation of its 340B rebate proposal, which would have harmed patients and 340B providers,” said Rick Pollack, AHA president and CEO. “We are especially appreciative of HRSA’s efforts to convince J&J to put an end to this unlawful proposal and those members of Congress who demonstrated their firm support of the 340B program.” 
  • Per another HHS press releases,
    • “The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), today announced that some Medicare enrollees will pay less for 54 drugs available through Medicare Part B. The drugs will have a lowered Part B coinsurance rate from October 1, 2024 – December 31, 2024, since drug companies raised prices for each of these 54 drugs faster than the rate of inflation. Over 822,000 people with Medicare use these drugs annually to treat conditions such as cancer, osteoporosis, and pneumonia. Since April 1, 2023, people with Medicare have seen savings on over 100 drugs thanks to Inflation Reduction Act’s Medicare Prescription Drug Inflation Rebate Program.” * * *
    • “For more information on the Medicare Prescription Drug Inflation Rebate Program visit, https://www.cms.gov/inflation-reduction-act-and-medicare/inflation-rebates-medicare.
    • “To view the fact sheet on the 54 Part B drugs with a coinsurance reduction for the quarter October 1, 2024 – December 31, 2024, visit, https://www.cms.gov/files/document/reduced-coinsurance-certain-part-b-rebatable-drugs-october-1-december-31-2024.pdf – PDF“
  • ICD10 Monitor identifies eleven key takeaways from ICD-10 changes that code changes that will go into effect for hospital discharges on Oct. 1, 2024.
  • HR Dive informs us,
    • Federal enforcement of new workplace protections for pregnant workers is picking up steam, just as regulations implementing those requirements reach 100 days on the books.
    • The U.S. Equal Employment Opportunity Commission filed its first lawsuit alleging violations of the Pregnant Workers Fairness Act earlier this month and followed it up with two more Wednesday [September 25].

From the public health and medical research front,

  • Beckers Clinical Leadership tells us,
    • “After its detection in 28 countries, the CDC began tracking the proportions of COVID-19 variant XEC. 
    • “Currently accounting for 6% of U.S. cases, XEC is the fifth most dominant variant in the nation. Other leading variants include KP.3.1.1 (58.7%), KP.2.3 (9.4%), LB.1 (7.9%) and KP.3 (7.1%). 
    • “As of Sept. 19, the XEC lineage has been detected in 633 COVID-19 cases after first appearing June 28, according to Scripps Research’s Outbreak.info. Twenty-four states have at least one XEC case. In early September, XEC was seen in 12 states and 15 countries. 
    • “It is too early to determine whether the variant is more transmissible or more severe than current strains, experts told NBC News in a Sept. 27 article.”
  • The Centers for Disease Control and Prevention (CDC) informs us,
    • “CDC reported one new flu-related death in a child last week, bringing the total number of U.S. pediatric deaths for the 2023-2024 season to 200. This number of pediatric deaths exceeds the previous high reported for a regular (non-pandemic) flu season. The previous high of 199 deaths was reported during the 2019-2020 season. Consistent with other seasons, of children who were eligible for a flu vaccine and for whom vaccination status was known, about 80 percent were not fully vaccinated.
    • “Getting your child a flu vaccine is the most effective step to reduce the risk of flu illness and flu-related doctor’s visits and missed school days; flu vaccination also reduces the risk of flu-related hospitalization and death. In the 2023-2024 season, estimates indicated that flu vaccination reduced the risk of flu related medical visits by approximately two-thirds and halved the risk of flu-related hospitalization for vaccinated children. September and October are the best times for most children to receive flu vaccine. CDC recommends everyone 6 months and older get an annual flu vaccine, especially children at higher risk for serious flu complications.”
  • The Washington Post reports,
    • “Nearly 90 percent of adults over 65 took prescription medication in the previous 12 months in 2021 and 2022, according to a recent report by the Centers for Disease Control and Prevention.
    • “Drawing on data from the 2021 and 2022 National Health Interview Survey, the report focused on 17,706 adults 65 and older. According to the analysis, 88.6 percent of older adults took prescription medications in the previous 12 months.
    • “Use was similar for men and women, but higher for those 75 and above than those 65 to 74. White older adults were also more likely than Black, Hispanic and Asian adults to take prescription medication. The study also found that 82.7 percent of older adults had prescription drug coverage, and that coverage was higher among men, White adults and those with higher incomes.”
  • Consumer Reports, writing in the Washington Post, offer tips about “how to deal with heel pain. Plantar fasciitis, Achilles’ problems and other issues can cause the tenderness. Stretches, the right footwear and shifting your activities can help.”
  • Healio notes,
    • “Hospitalized older adults are more likely to die from RSV than influenza B, though the risk is similar for influenza A.
    • “Improved testing strategies and outreach could lower the risk for death.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “CVS Health is conducting a strategic review of options for the company, including a possible breakup of the industry giant, according to people with knowledge of the matter. 
    • “The company’s board of directors has retained bankers to facilitate the review, which has been ongoing for weeks, the people said. 
    • “No decision by CVS is imminent, and it is possible there won’t be any major changes in the business as a result, they added. 
    • “The review includes different options, including various forms a potential breakup could take, some of the people said.”
  • Per Beckers Hospital Review,
    • “Dana Filmore, a grandmother from Columbus, Ohio, is among thousands of plaintiffs filing a federal lawsuit against pharmaceutical companies Novo Nordisk and Eli Lilly, alleging Ozempic and Mounjaro caused gastroparesis, USA Today reported Sept. 27. 
    • “Gastroparesis, a condition characterized by stomach paralysis that severely impacts digestion, caused Filmore, who turned to the medication to control her blood sugar to have persistent nausea and bowel issues. 
    • “The lawsuit alleges that the drug manufacturers failed to adequately warn patients about the risks associated with the medications and central to the lawsuit were claims of gastroparesis, according to the USA Today report.”
  • Per MedTech Dive,
    • “Establishment Labs received Food and Drug Administration approval for its Motiva breast implants for primary and revision breast augmentation.
    • “Motiva is the first new breast implant to receive U.S. premarket approval since 2013, according to Establishment Labs’ Thursday announcement. Since then, the market has been reshaped by safety problems that led to the withdrawal of Allergan’s Biocell textured breast implant.
    • “Motiva devices have a surface designed to enhance biocompatibility and promote low inflammation, according to the company. Establishment Labs won approval on the strength of three-year clinical data.”

Weekend Update

David Ermer–Congress, COVID-19 testing, FDA, Medical / Rx research, Mental health care, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by B VV on Unsplash

From Washington, DC

  • Congress is on the campaign trail until sometime after the national election on November 5.
  • The Supreme Court will hold its opening conference of its October term 2024 tomorrow. Among the cert petitions to be considered is the State of Oklahoma’s challenge to a 10th Circuit opinion holding that ERISA preempts an Oklahoma PBM reform law (No. 23-1213). That opinion is helpful to FEHB carriers. A Supreme Court decision to grant Oklahoma’s petition would be posted on FriCBS day October 4. A Supreme Court decision to deny Oklahoma’s petition or ask the Solicitor General for her views would be posted on Monday October 7.
  • MedCity News delves into the FTC’s recent administrative complaint against the big three PBMs’ handling of insulin pricing.

From the public health and medical research front,

  • CBS News reports that “Free COVID tests [from the federal government] are back. But there are more accurate tests for sale.”
  • Per NPR Shots,
    • “Three-dimensional imaging outperformed older digital mammography at reducing anxiety-producing callbacks for more breast cancer testing, a new study shows. The research, published this month in the journal Radiology also suggests the newer technology might find more worrisome cancers earlier during routine screenings.
    • “Lead author Dr. Liane Philpotts, a Yale School of Medicine radiology professor, hailed 3D mammography, also known as digital breast tomosynthesis or DBT, as “a win, win, win.”
    • “We have the benefit of a lower recall rate, or fewer false positives. We have increased cancer detection, and we have a lower rate of advanced cancers,” she said. “So it’s truly a game changer.” * * *
    • “Still, the new study, fails to definitively answer the question of whether newer, more expensive 3D mammography finds troublesome breast cancers earlier than 2D mammography, sparing women harsh treatment and saving lives, an accompanying editorial says.
    • “The verdict won’t come until 2030, at the conclusion of a large-scale randomized controlled trial comparing 3D to 2D mammography, according to the editorial written by two Korea University Guro Hospital radiology professors.
    • “Pending the 2030 trial results, the editorial concludes, the new study provides “indirect evidence suggesting the potential of DBT screening in improving survival outcomes.” 
  • Fortune Well asks us “Getting enough sleep but still exhausted? These 7 types of rest can help.”
  • The Washington Post lets us know,
    • “Suicide rates are lower in U.S. counties with more health insurance coverage and broadband internet access and higher income, a recent Centers for Disease Control and Prevention analysis suggests.
    • “The report analyzed more than 49,000 suicide deaths in 2022 from the National Vital Statistics database. Researchers compared county suicide rates to the percent of residents with health insurance coverage, households with broadband access and households with income above the federal poverty level.
    • ‘The overall U.S. suicide rate in 2022 was 14.2 per 100,000 people, the CDC report said. Suicide rates were highest among non-Hispanic American Indians or Alaska Natives (27.1 per 100,000 population) and White people (17.6 per 100,000). The suicide rate for boys and men was nearly four times higher than for girls and women (23 per 100,000 for males vs. 5.9 per 100,000 for females). Rural residents and those ages 45 to 64 (19 per 100,000) and 24 to 44 (18.9 per 100,000) had the highest suicide rate, according to the CDC report.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Dr. Ralph de la Torre, a former heart surgeon who built and became the face of Steward Health Care and its network of neglected hospitals, is stepping down from the company Tuesday and will no longer serve as board chairman and chief executive, the company said in a statement to the Globe Saturday.
    • “With his affinity for luxury yachts and corporate jets, de la Torre became a symbol of greed in for-profit health care, amid mounting stories this year of patients harmed by shortages of staff and critical supplies at Steward hospitals. De la Torre is believed to hold a majority of shares in the private company, which was one of the nation’s largest for-profit, private health care systems, and is now being taken apart in bankruptcy proceedings.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration on Friday approved Regeneron Pharmaceuticals and Sanofi’s inflammatory disease drug Dupixent for a common lung condition. The decision could significantly expand use of what is already one of the industry’s best-selling medicines.
    • “Dupixent is now cleared for use as an add-on maintenance treatment for adults with a certain kind of chronic obstructive pulmonary disease, or COPD, that can’t be controlled with other medications.
    • “The decision makes Dupixent the first biologic medicine approved in the U.S. for COPD, a lung disease that makes it difficult to breathe and is typically treated with inhaled medicines. Regeneron estimates about 300,000 people in the U.S. have the specific type of COPD that would make them eligible for treatment with Dupixent, which is administered via injection under the skin.”
  • Per Healthcare Dive,
    • “When independent hospitals are acquired by multi-hospital health systems, they experience boosts to profitability and efficiency, according to a new study published in the Journal of Political Economy Microeconomics this week. 
    • “Acquired hospitals saw profitability increase by about $14 million per year, on increased consumer prices and cuts to nonclinical staff. 
    • “However, when corporate-owned hospitals are acquired by other health systems, they do not experience similar efficiency gains, the study found, suggesting there is likely a limit to how much consolidation can benefit hospital performance.”

Friday Factoids

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

From Washington, DC,

  • Per a CMS press release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) announced that average premiums, benefits, and plan choices for Medicare Advantage (MA) and the Medicare Part D prescription drug program will remain stable in 2025. Average premiums are projected to decline in both the MA and Part D programs from 2024 to 2025. Enhancements adopted in the 2025 MA and Part D Final Rule, as well as payment policy updates in the 2025 MA and Part D Rate Announcement, support this stability and increase enrollee protections and access to care for people with Medicare. In addition, the Inflation Reduction Act is reducing prescription drug costs and delivering more comprehensive benefits than ever before, including an annual $2,000 cap on out-of-pocket drug costs. CMS is committed to ensuring these programs work for people with Medicare, that they have access to strong and stable choices, and that they have the information they need to make informed choices about what is best for them. 
    • “CMS is releasing this key information, including 2025 premiums, benefits, and access to plan options for MA and Medicare Part D prescription drug plans, ahead of the upcoming Medicare Open Enrollment, which runs from October 15, 2024, to December 7, 2024, to help people with Medicare determine the best Medicare coverage option for their health care needs. * * *
    • “For more information on MA and Medicare Part D offerings for 2025, view the fact sheet. 
    • “To view the premiums and costs of 2025 Medicare Advantage and Part D plans, please visit https://www.cms.gov/medicare/coverage/prescription-drug-coverage. Select the 2025 landscape source file in the downloads section of the webpage. This year, CMS has combined the Landscape files into one file, instead of five individual files as was the case historically, and made additional enhancements to improve the end-user experience and simplify the format. The accompanying readme file at the link above provides important notes about the format and file columns.    
    • “For state-by-state information, important dates, and enrollment resources for Medicare Advantage and Part D in 2025, please visit: https://www.cms.gov/files/document/2025-ma-part-d-landscape-state-state-fact-sheet.pdf.
    • “For information on the Medicare Advantage Value-Based Insurance Design Model, including plan participation in 2025, please visit: https://www.cms.gov/newsroom/fact-sheets/medicare-advantage-value-based-insurance-design-model-calendar-year-2025-model-participation.” 
  • Beckers Payer Issues offers ten notes on the CMS press release.
  • The American Hospital Association News lets us know,
    • “The Health Resources and Services Administration Sept. 27 sent a final warning letter to Johnson & Johnson urging the company to inform the agency by Monday, Sept. 30 that it would halt its proposed 340B rebate model scheduled to go into effect next month. 
    • “As outlined in HRSA’s September 17, 2024, letter, if J&J proceeds with implementing its rebate proposal without Secretarial approval, it will violate section 340B(a)(1) of the Public Health Service Act,” HRSA wrote today. “If J&J has not notified HRSA that it is ceasing implementation of its rebate proposal by September 30, 2024, HRSA will begin the process outlined in J&J’s Pharmaceutical Pricing Agreement related to terminating the agreement. In addition, if J&J moves forward with implementation of its rebate proposal, HRSA will initiate a referral to the HHS Office of Inspector General pursuant to 42 U.S.C. § 256b(d)(1)(B)(vi).” 
  • Federal. News Network informs us,
    • “Postmaster General Louis DeJoy is telling lawmakers the Postal Service is ready to handle a high volume of mail-in ballots ahead of Election Day.
    • “DeJoy told members of the House Appropriations Committee on Thursday that USPS has a “track record of success” delivering ballots.
    • “In 2020, at the height of the COVID-19 pandemic, USPS delivered 99.89% of ballots from voters to election officials within seven days.
    • “That year, when USPS delivered a “historically high number of ballots,” DeJoy said they accounted for just 0.1% of its annual mail volume.
    • “We will be even better prepared for 2024,” DeJoy said. “Our network is designed to readily handle a surge in mail volume, just like we do every election and holiday season.”
    • “DeJoy recommends voters mail their ballots early, at least seven days before their state’s election deadline.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated.
    • “COVID-19
      • “There are continued signs of declines in COVID-19 activity in many areas. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations are decreasing. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
      • “Vaccinations to prevent fall respiratory virus have started for the 2024-25 respiratory illness season with 4.5% of adults 18 years and older reporting receipt of the updated 2024-25 COVID-19 vaccine and 9.6% reporting receipt of an influenza vaccine. Among adults 75 years and older, 34.0% reported ever receiving an RSV vaccine. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.”
  • The University of Minnesota CIDRAP informs us,
    • Wastewater levels for COVID-19 remain high but low for RSV and influenza. Of flu cases identified through specimens testing, the H1N1 strain accounts for 53.5% of cases, H3N2 for 46.5%, and influenza B for 1.2%. Influenza test positivity for the week ending on September 21 was 0.6%.
  • and
    • “A new study on COVID-19’s effects on US infants notes that the proportion of hospitalized babies of mothers vaccinated during pregnancy plunged from 18% in October 2023 to 4% in April 2024, underscoring the need for increased vaccine uptake.
    • “And another report estimates that unexpected infant deaths jumped as much as 14% in 2021 relative to pre-pandemic totals.”
  • and
    • “A pair of new studies on COVID-19 antiviral drugs suggest that resistance mutations that emerge after treatment with nirmatrelvir-ritonavir (Paxlovid) or remdesivir (Veklury) are rare and that almost a third of US adults have never heard of Paxlovid.”
  • The American Hospital Association News points out,
    • “The National Foundation for Infectious Diseases Sept. 25 released a survey showing that less than one in five U.S. adults are concerned about themselves or a family member getting a respiratory virus infection this fall and winter. The survey, conducted in August, found that 20% are concerned about COVID-19, 17% are concerned about flu, 17% are concerned about pneumococcal disease and 16% are concerned about respiratory syncytial virus. Additionally, it found that while 67% of adults agree that an annual flu vaccination is the most effective way to prevent flu-related hospitalizations and deaths, 45% said they do not plan to or are unsure if they will receive a flu vaccine this season, and 38% said they definitely plan to. Regarding COVID-19, 26% of adults said they will definitely get an updated vaccine. Among those for whom a vaccine is recommended, only 21% said they will definitely get an RSV vaccine and 24% said they would definitely receive one against pneumococcal disease.”
  • The New York Times reports,
    • “A possible cluster of bird-flu infections in Missouri has grown to include eight people, in what may be the first examples of person-to-person transmission in the United States, the Centers for Disease Control and Prevention reported on Friday.
    • “If confirmed, the cases in Missouri could indicate that the virus may have acquired the ability to infect people more easily. Worldwide, clusters of bird flu among people are extremely rare. Most cases have resulted from close contact with infected birds.
    • “Health officials in Missouri initially identified a patient with bird flu who was hospitalized last month with unusual symptoms. The patient may have infected one household member and six health care workers, all of whom developed symptoms, according to the C.D.C.
    • “Investigators have not yet confirmed whether any of those seven individuals were infected with the virus, called H5N1, leaving open the possibility that they had Covid or some other illness with flulike symptoms.”
  • and
    • “Major heart defects are more common — but still rare — in babies conceived through certain fertility treatments, including in vitro fertilization, researchers reported on Thursday in the largest study of its kind.
    • “The research, which included medical records of more than seven million Nordic children, also bolstered evidence that I.V.F. is associated with a small but significant uptick in birth abnormalities.
    • “It’s an increased risk, but the absolute risk is very small,” said Dr. Ulla-Britt Wennerholm, the senior author of the paper and a professor of obstetrics and gynecology at the University of Gothenburg in Sweden.
    • “I think that’s a reassuring finding, actually.”
    • “The study focused on children born between 1984 and 2015 in Denmark, Sweden, Norway and Finland as a result of a class of fertility treatments called assisted reproductive technology, the most common of which is I.V.F.”
  • STAT News tells us,
    • “Prostate cancer presents a tricky screening challenge. Catching it early could mean dodging a painful journey with advanced cancer. Yet a sizable majority of prostate cancers are “indolent” — slow growing tumors that most likely would never metastasize during the patient’s lifetime, and whose treatment  would do more harm than good.
    • “Experts have long clashed over these considerations, with some arguing that the harms of PSA testing outstrip the benefits and others adamant that lives are saved with screening. The balance may now be shifting as researchers and physicians find methods that reduce the harms of screening, in particular with the use of MRI. A new study published in the New England Journal of Medicine on Wednesday showed using MRI scans can reduce unnecessary diagnosis and treatment of screen-detected prostate cancer by more than half.
    • “That result should be a reason for experts to rethink prostate cancer screening guidelines with MRI in mind, according to Jonas Hugosson, a professor of urology at the University of Gothenburg in Sweden and the study’s lead author. “In my opinion, this is the last piece of the puzzle to have real evidence that the benefits of prostate screening exceed the harms on a population level,” he said. “This paper is the message to healthcare authorities around the world to look over recommendations for men.”
    • “That may be easier said than done, other experts said. There may not be enough MRI infrastructure to support a prostate screening program requiring the scans.” 
  • STAT News also calls attention to the fact that the “Sickle cell community scrambles to find safe plan after a drug is pulled from the market. Pfizer’s abrupt decision left many feeling they had no guidance on what to do next.”
    • “The vast majority of Americans with the disease are Black, its research long neglected, its care long suffused with racism and stigma. “There’s a lot of people in the sickle cell warrior community where they felt like, historically, they’ve been guinea pigs,” said Habib.
    • “This week, the feeling can cut two ways, in the sense that some patients may have been prescribed a medication that may have been dangerous, and in the sense that some are losing something helpful with no warning. It wasn’t just the news about a drug that some people had been taking daily for years; it was how it was rolled out, with little warning or guidance. One patient advocate said she was too devastated to comment. Another was so shocked she didn’t believe it at first. 
    • “You know I’m just worried about everyone’s safety. I want to make sure no one is having extreme side effects,” said Quannecia McCruse, president and CEO of the Sickle Cell Association of Houston, who had considered quitting her Oxbryta cold turkey this week because she’s done so before and had no issues. Yet she also found the whole thing weirdly precipitous, and wondered if the drug might still end up in the medicine cabinet — perhaps for a more specific group. “Not one sickle cell person is like another.”
  • The New York Times identifies five common signs of dementia other than memory loss
    • Financial problems,
    • Sleep issues,
    • Personality changes,
    • Driving difficulties, and
    • Loss of smell.
  • The New York Times also notes,
    • “Women are increasingly using guns to die by suicide in the United States, challenging long-held assumptions that they will usually resort to less lethal means, according to data released on Thursday by the Centers for Disease Control and Prevention.
    • “Gun-related suicide is most often associated with men, largely because men are more likely than women to purchase guns and to die by suicide. But in 2020, gun-related suicides surpassed poisoning and suffocation for the first time among women and have continued to rise since then.
    • “Suicide attempts with guns are far more lethal than those by other means, and firearm injuries now account for more than half of all suicide deaths.
    • “The findings, drawn from federal health data, showed that in 2022, 20 out of every million women used a gun to die by suicide, up from 14 women in 2002. This marks a 43 percent increase. The report also found that suicide rates have risen among women over the past two decades.”

From the U.S. healthcare business front,

  • The Institute for Clinical and Economic Research follows up on yesterday’s FEHBlog post,
    • “The FDA approved Karuna Therapeutics’ xanomeline tartrate/trospium chloride (also known as KarXT) for schizophrenia yesterday.
    • “ICER released a Final Evidence Report assessing the comparative clinical effectiveness and value of KarXT this year. At ICER’s public meeting, the independent appraisal committee voted that current evidence is not adequate to demonstrate superior net health benefits for KarXT compared to generically available aripiprazole. If long-term data confirm KarXT’s benefits and lack of weight gain, KarXT would achieve common thresholds for cost-effectiveness if priced between $16,000 to $20,000 per year. Karuna Therapeutics [ a subsidiary of Bristol, Myers, Squibb] priced the therapy close to the upper bound of ICER’s recommended range, at $22,500 per year.
    • “ICER’s Chief Medical Officer David Rind, MD, MSc stated:
      • “Schizophrenia is a serious mental illness that affects how a person thinks, feels, and behaves. Among the important side effects of current treatments is weight gain leading to metabolic syndrome. This, in turn, places patients at risk for cardiovascular events and death. KarXT has a novel mechanism of action and, at least in the short run, does not seem to cause weight gain. This may lead to major health benefits compared with existing treatments, however current evidence on benefits and harms is limited.” 
  • Fierce Healthcare lets us know,
    • “As employers face rising costs, many are looking to rethink plan designs rather than emphasize shifting expenses to workers, according to a new WTW report.
      WTW released its 2024 Best Practices in Healthcare Survey on Thursday, which polled 417 employers representing 6 million workers. It found that these firms are expecting costs to balloon by 7.7% in 2025, compared to an increase of 6.9% in 2024 and 6.5% for 2023.
    • “Despite the increase, however, only 34% told WTW that they intend to shift those costs to employees by raising premiums. Twenty percent said they will push high-deductible health plans or account-based coverage to address costs.
    • “Instead, 52% said they intend to roll out programs that reduce total costs, and 51% said they would use plan designs and network models to steer workers to lower-cost and higher-quality providers.”

Thursday Miscellany

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, OPM, U.S. Healthcare–

From Washington, DC

  • Per a White House press release,
    • “On Thursday, September 26, 2024, the President signed into law:
    • “H.R. 9747, the ”Continuing Appropriations and Extensions Act, 2025,” which provides fiscal year 2025 appropriations to Federal agencies through December 20, 2024, for continuing projects and activities of the Federal Government.”
  • Bye, bye Congress. See you in November.
  • MedTech Dive adds,
    • “Congress has again deferred Medicare reimbursement cuts of up to 15% for clinical laboratory tests with the passage Wednesday of a short-term government funding bill.
    • “The appropriations bill pushes back by one year the implementation of Medicare payment rates scheduled to take effect in January for about 800 lab services.
    • “We are pleased that Congress has delayed pending reductions, recognizing the harm repeated Medicare reductions would have on the nation’s health care system that relies on clinical laboratory testing every day to inform patient care,” Susan Van Meter, president of the American Clinical Laboratory Association, said in a Wednesday statement.”
  • Here are links on yesterday’s OPM’s 2025 FEHBP/FEDVIP premium announcement from Govexec, Fedweek and FedSmith. Govexec also reports, “Biden administration officials said that two nationwide insurers in the federal government’s employer-sponsored health care program [Blue Cross FEP and GEHA] will offer $25,000 worth of in vitro fertilization and other fertility treatments.
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS) through the Advanced Research Projects Agency for Health (ARPA-H) announced funding for the Transforming Antibiotic R&D with Generative AI to stop Emerging Threats (TARGET) project, which will use AI to speed the discovery and development of new classes of antibiotics. This program is another action to support the United States’ longstanding commitment to combating antimicrobial resistance (AMR), from groundbreaking innovation to international collaboration. The U.S. is a global leader in the fight against AMR and has a demonstrated track record of progress in protecting people, animals, and the environment from the threat of AMR domestically and globally.”

From the public health and medical research front,

  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration approved [Bristol, Myers, Squibb’s] Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care.
    • “Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that is often damaging to a person’s quality of life,” said Tiffany Farchione, M.D., director of the Division of Psychiatry, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This drug takes the first new approach to schizophrenia treatment in decades. This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed.”
  • BioPharma Dive offers an excellent explanation of the various factors affecting sales of this drug.
  • KFF Health News points out that “Deadly High Blood Pressure During Pregnancy Is on the Rise.”
  • The Washington Post reports,
    • “A New York resident has died amid a nationwide listeria outbreak tied to Boar’s Head deli meat, the Centers for Disease Control and Prevention announced Wednesday, bringing the death toll to 10 in the largest outbreak of the foodborne illness since 2011.
    • “The agency also reported two new hospitalizations associated with the outbreak. In total, 59 people have been hospitalized in 19 states since late May.
    • “Deaths have occurred in Illinois, New Jersey, New York, Virginia, Florida, Tennessee, New Mexico and South Carolina. In its latest update, the CDC noted that illnesses have started to decrease. The number of sick people is probably higher than the official case count, the agency said, since those who do not seek medical care are not tested for listeria.
    • “Boar’s Head identified the production process for liverwurst at its plant in Jarratt, Va., as the culprit for contaminating the meat. This month, the company announced it would indefinitely close the southern Virginia plant and permanently discontinue liverwurst.”
  • The NIH Director writes in her blog,
    • “Genetic mutations affect nearly all human diseases. Some genetic disorders such as cystic fibrosis are caused by mutations in a single gene that a person inherits from their parents. Other diseases can be caused by changes in multiple genes or from a combination of gene mutations and environmental factors. We still have a lot to learn about the complex ways that variations in our genes affect health and disease.
    • “Researchers investigating genetic disorders have primarily studied mutations that cause our cells to alter the makeup of proteins, like the most common mutations that cause cystic fibrosis. Less research has been done on alterations called synonymous mutations, which have been called “silent” because they don’t alter the makeup of proteins, leading scientists to long assume that these kinds of mutations don’t produce any noticeable differences in our biology or health. However, recent research has shown that synonymous mutations can lead to significant changes in a cell’s ability to survive and grow. A new NIH-supported study reported in Proceedings of the National Academy of Sciences sheds additional light on the impact of synonymous mutations and their effect on the way proteins are made.” * * *
    • “The researchers behind this study, at the University of Notre Dame in Notre Dame, IN, wanted to understand how synonymous mutations may affect how much protein is made and whether proteins are folded correctly in cells. Misfolded proteins are known to play roles in numerous diseases, including cystic fibrosis, Alzheimer’s disease, and some cancers. The study team, led by Patricia L. Clark, who received an NIH Director’s Pioneer Award in 2021 for this work, has shown that synonymous mutations in a particular gene in Escherichia coli (E. coli) bacteria can alter how the encoded protein folds as it is being made, by altering the rate at which cells produce each copy of the protein. The new research goes a step further and shows that silent mutations in one gene can affect the amount of protein produced from a separate, neighboring gene.” * * *
    • “This discovery in E. coli may have important implications for understanding the bacteria’s biology and evolution. Clark’s team continues to study this system to learn more. Their findings may also prove to have broader implications for biology, including for some genetic disorders. It’s an area that warrants more study and attention, to better understand the roles that synonymous mutations may be playing in genes and their effects on human health.”
  • Per an NIH press release,
    • “Scientists at the National Institutes of Health (NIH) and their colleagues have identified a gene responsible for some inherited retinal diseases (IRDs), which are a group of disorders that damage the eye’s light-sensing retina and threatens vision. Though IRDs affect more than 2 million people worldwide, each individual disease is rare, complicating efforts to identify enough people to study and conduct clinical trials to develop treatment. The study’s findings published today in JAMA Ophthalmology.
    • “In a small study of six unrelated participants, researchers linked the gene UBAP1L to different forms of retinal dystrophies, with issues affecting the macula, the part of the eye used for central vision such as for reading (maculopathy), issues affecting the cone cells that enable color vision (cone dystrophy) or a disorder that also affects the rod cells that enable night vision (cone-rod dystrophy). The patients had symptoms of retinal dystrophy starting in early adulthood, progressing to severe vision loss by late adulthood.
    • “The patients in this study showed symptoms and features similar to other IRDs, but the cause of their condition was uncertain,” said Bin Guan, Ph.D., chief of the Ophthalmic Genomics Laboratory at NIH’s National Eye Institute (NEI) and a senior author of the report. “Now that we’ve identified the causative gene, we can study how the gene defect causes disease and, hopefully, develop treatment.”
    • “Identifying the UBAP1L gene’s involvement adds to the list of more than 280 genes responsible for this heterogeneous disease.”
  • The U.S. Preventive Services Task Force posted a “Final Research Plan for Enhanced Risk Assessment for Cardiovascular Disease: Coronary Artery Calcium Scoring.”

From the U.S. healthcare business front,

  • The FEHBlog was surprised to read in Beckers Hospital Review that
    • Johnson & Johnson will discontinue upfront 340B drug rebates for certain hospitals, raising concerns among healthcare providers and advocacy groups. The proposed policy, set to take effect Oct. 15, would prevent certain hospitals from accessing 340B discounts for Stelara, used to treat plaque psoriasis, psoriatic arthritis and other conditions; and Xarelto, a blood thinner.
  • Per Fierce Healthcare,
    • “While consumers give telehealth high marks for convenience, overall experience is fairly mixed, according to a new report.
    • “J.D. Power released its annual Telehealth Satisfaction Study on Thursday, and found patients overall gave a score of 730 out of 1,000 for direct-to-consumer telehealth platforms. Payer-provided telehealth earned a lower score of 708, which suggests patients encounter differences in quality and ease of access between providers.
    • “The study also found the highest satisfaction scores for people enrolled in Medicaid, those living in urban areas, millennials and Gen Zers. The lowest scores were among people enrolled in Medicare or commercial coverage, those living in suburban regions and members of the Boomer generation or older.”
  • McKinsey and Company explore “Reimagining healthcare industry service operations in the age of AI.”
  • KFF offers “A Snapshot of Sources of Coverage Among Medicare Beneficiaries” and tells us “Nearly 7 in 10 Medicare Beneficiaries Did Not Compare Plans During Medicare’s Open Enrollment Period.”

OPM Publishes 2025 FEHB and FEDVIP Premiums

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, Obesity, OPM, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From the FEHB / FEDVIP front,

  • Federal News Network tells us,
    • “Enrollees in the Federal Employees Health Benefits (FEHB) program are about to see the largest annual increase in their health insurance costs in at least a decade.
    • “Beginning in January, federal employees and annuitants enrolled in FEHB will pay 13.5% more, on average, toward their health care premiums, according to data the Office of Personnel Management released Wednesday.
    • “The significant premium increase for FEHB plan year 2025 follows a 7.7% jump for 2024, and an 8.7% increase in 2023. OPM said the increase reflects changes in the market over the last year, and generally aligns with other programs in the commercial market.
    • “The premium increases are due to the impact of price increases by providers and suppliers, increased utilization of certain prescription drugs and behavioral health spending,” OPM said. “Industry-wide cost pressures affect FEHB and PSHB rates similarly.” * * *
    • “Across the 42 health carriers for 2025, FEHB participants will see 64 plans and a total of 130 plan options.
    • “PSHB participants will, by contrast, have 69 plan options offered across 30 health carriers. That includes seven fee-for-service carriers and 23 health maintenance organizations (HMOs) available through the PSHB.”
  • Here is a link to OPM’s 2025 FEHB/PSHBP premiums website.
    • Federal Employees Health Benefits (FEHB)
      • “The 2025 biweekly maximum government contribution for most employees and annuitants (72% of the weighted average) is $298.08 for Self Only, $650.00 for Self Plus One, and $714.23 for Self and Family. The monthly maximum government contribution (72% of the weighted average) is $645.84 for Self Only, $1,408.33 for Self Plus One and $1,547.50 for Self and Family.
      • “For 2025, the biweekly program-wide weighted average premiums for Self Only, Self Plus One, and Self and Family enrollments with a government contribution are $414.00, $902.78, and $991.99, respectively. The monthly program-wide weighted average premiums for Self Only, Self Plus One, and Self and Family enrollments with a government contribution are $897.00, $1,956.02, and $2,149.31, respectively.”
    • Postal Service Health Benefits (PSHB)
      • “The 2025 biweekly maximum government contribution for most employees and annuitants (72% of the weighted average) is $286.09 for Self Only, $618.40 for Self Plus One, and $672.95 for Self and Family. The monthly maximum government contribution (72% of the weighted average) is $619.86 for Self Only, $1,339.87 for Self Plus One and $1,458.06 for Self and Family.
      • “For 2025, the biweekly program-wide weighted average premiums for Self Only, Self Plus One, and Self and Family enrollment with a government contribution are $397.35, $858.89, and $934.65, respectively. The monthly program-wide weighted average premiums for Self Only, Self Plus One, and Self and Family enrollments with a government contribution are $860.93, $1,860.93, and $2,025.08, respectively.”
  • Federal News Network adds,
    • “In contrast to the large increases for FEHB and PSHB premiums, the average premium rate increases for the Federal Employees Dental and Vision Insurance Program (FEDVIP) will be relatively small in 2025.
    • “Premiums will rise for FEDVIP dental plans by 2.97% on average, while vision plans will go up by 0.87%, OPM said.
    • “FEHB and PSHB participants will both be able to select from seven dental carriers offering 14 nationwide plan options for 2025. There will also be 10 nationwide vision plans available nationwide across five different carriers next year.”
  • Here is a link to the OPM website with 2025 FEDVIP premiums.

From Washington, DC,

  • The Washington Post reports,
    • “Congress passed legislation on Wednesday to fund the government into December and send more than $230 million in emergency funding to the Secret Service.
    • “Lawmakers had a deadline of Monday to pass new financing bills and avoid a government shutdown. The new legislation extends that deadline to Dec. 20 and funds the government at current levels until then.
    • “House Speaker Mike Johnson (R-La.) relied on support from Democrats — rather than just his own GOP majority — to approve the funding. The House earlier rejected a measure Johnson preferred that would have extended the deadline into March and included a new requirement to prove citizenship when registering to vote in federal elections. The Senate passed it very quickly later Wednesday evening on a bipartisan basis.
    • “The short-term spending bill, also known as a continuing resolution or CR, will set up a frenzied year-end period to pass annual spending bills before the next president takes office.”
  • The Washington Post adds,
    • “Democrats on Wednesday launched a legislative push to extend federal subsidies that defray the cost of health insurance for millions of Americans. The effort tees up another Affordable Care Act fight that could stretch into next year — and perhaps challenge the next president.
    • “Sens. Jeanne Shaheen (D-N.H.) and Tammy Baldwin (D-Wis.) introduced legislation to make permanent tax credits that lower the cost of plans sold through the Affordable Care Act. Rep. Lauren Underwood (D-Ill.), who helped craft the initial legislation to create the expanded tax credits almost four years ago, introduced companion legislation in the House. Senate Majority Leader Charles E. Schumer (D-N.Y.) and House Minority Whip Katherine Clark (D-Mass.) joined Shaheen and Underwood at a news conference to unveil the legislation Wednesday.
    • “Congress must “take swift action at the first legislative opportunity to make the tax credits permanent,” Underwood said in an interview.”
  • and
    • “The Senate voted unanimously Wednesday to hold Steward Health Care CEO Ralph de la Torre in contempt of Congress, asking the Justice Department to pursue criminal charges against the hospital executive for failing to comply with a congressional subpoena.
    • “It is the first time since 1971 that the Senate has asked the Justice Department to pursue criminal contempt charges against an individual, lawmakers said. Steward, a for-profit company that owns about two dozen hospitals across the country, is engaged in bankruptcy proceedings and has been seeking to sell its hospitals.
    • “Community leaders and health workers in states served by Steward’s facilities have blamed the company’s leaders for extravagant paydays even as hospitals struggled to meet mortgage payments and cover other expenses. The Justice Department also has been investigating the company regarding allegations of fraud.”
  • Healthcare Dive lets us know,
    • “Regulators need to boost oversight over remote patient monitoring in Medicare to avoid fraud, according to a report by the HHS’ Office of Inspector General. 
    • “About 43% of Medicare beneficiaries who received remote patient monitoring didn’t get all three components of the service, including the monitoring device, education and setup, and treatment management.
    • “Medicare doesn’t have critical information about the remote monitoring it pays for —  like what data is being monitored, what types of devices beneficiaries use and which provider ordered the service — complicating oversight efforts, according to the OIG.”
  • and
    • “The Biden administration has finalized a rule targeting fraudulent billing in Medicare’s largest value-based care program, after concerning reports of spiking spending on urinary catheters.
    • “The anomalous billing had the potential to hurt accountable care organizations, or ACOs, in the Medicare Shared Savings Program by impairing their ability to capture shared savings. ACOs are groups of providers that assume responsibility — and occasionally, financial risk — to care for a group of patients.
    • “However, the CMS’ rule finalized Tuesday shields ACOs by excluding payments for suspect catheter billing codes from the 2023 performance year.”
  • Per Modern Healthcare,
    • “Medicare will begin compensating hospitals for providing quality data to support “age-friendly” medical care as the government seeks to bolster private sector efforts to adapt to the aging population.
    • “Starting in January, hospitals will report on a slew of measures to assess whether they are improving care for older patients in emergency departments, operating rooms and other settings. The Centers for Medicare and Medicaid Services laid out the new policy in the Medicare Inpatient Prospective Payment System final rule for fiscal 2025, which it published last month.”
  • Per an HHS press release,
    • “Today, the 988 Suicide & Crisis Lifeline announced that the process to start routing cellular phone calls to 988 contact centers based on the caller’s approximate location, versus by area code — known as “georouting” — began last week with two major U.S. wireless carriers that combined make up about half of all wireless calls to 988. The U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) and the 988 Network Administrator, Vibrant Emotional Health, have been working with all of the major U.S. cell phone carriers for more than a year to improve call routing to 988 so that callers on a cell phone can be connected more locally to centers that are better equipped to provide nearby resources and services.”

From the public health and medical research front,

  • NBC News reports,
    • “Nearly 1 in 3 Americans may have an undiagnosed iron deficiency, a problem that can lead to fatigue, brain fog and difficulty concentrating, a new study suggests. 
    • “An analysis of data from more than 8,000 adults in the U.S. revealed that 14% had low iron blood levels, a condition known as absolute iron deficiency, while 15% had the right iron levels but their bodies couldn’t use the essential mineral properly, known as functional iron deficiency, according to the report published Tuesday in JAMA Network Open.
    • “Doctors don’t typically screen adults for iron deficiency, which is why the condition has been overlooked in many people.
    • “The researchers weren’t surprised at the results, however. There had been hints in other studies suggesting iron deficiency might be more widespread than doctors assume.” 
  • Per The Washington Post,
    • “You might think that people would be lining up to get a highly effective vaccine for a relatively common disease that can cause such pain, but that’s not the case. The CDC recommends two doses of Shingrix for everyone 50 and older, yet only 18.6 percent of people in the United States in this age group have received at least one dose, according to CDC data from 2021.
    • “Jonathan Lowe says many people don’t understand how bad shingles can be.
    • “A television reporter and anchor in Charlotte, Lowe was diagnosed with shingles in March, and it took five months for him to fully recover and start anchoring a newscast again.”
  • The Wall Street Journal reports,
    • “Pfizer said it is voluntarily withdrawing all lots of its sickle-cell drug Oxbryta in all markets where it is approved, two years after acquiring its parent company Global Blood Therapeutic in a $5.4 billion deal.
    • “The drugmaker said Wednesday the decision is based on clinical data that now indicate the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle-cell patient population.
    • “Pfizer also said it has notified regulatory authorities about its latest findings about Oxbryta.”
  • Per an NIH press release,
    • “Adults with opioid use disorder who receive a higher daily dose of the opioid addiction treatment medication buprenorphine may have a lower risk of subsequent emergency department visits or use of inpatient services related to behavioral health (such as for mental health and substance use disorders) than adults receiving the recommended dose, according to an analysis funded by the National Institutes of Health (NIH). These findings suggest that higher buprenorphine doses could be more effective in managing opioid use disorder, which may be particularly relevant for improving treatment for those who use fentanyl, a major driver of the overdose crisis.” * * *
    • “These findings build upon accumulating evidence of the safety and efficacy of higher doses of buprenorphine. Studies have shown that more than 16 mg of buprenorphine is safe and well tolerated in people with opioid use disorder in emergency department and outpatient treatment settings, and that higher buprenorphine doses are associated with improved retention in treatment for opioid use disorder.”
  • The National Cancer Institute posted its Cancer Information Highlights on “GI Problems | Whole-Body Effects of Cancer | Potential Drug Targets.”

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Wall Street analysts greeted research announcements from Amgen about two immunology medicines with skepticism, saying the results suggest the drugs won’t pose a major challenge to market leaders. 
    • “Amgen shared the top-line results from two Phase 3 trials during an investor presentation Tuesday. In the first, Amgen’s experimental rocatinlimab showed statistically significant improvement versus placebo for patients with atopic dermatitis, a form of eczema. In the second study, the drug Uplizna succeeded in treating generalized myasthenia gravis.
    • “But in research notes published following the presentation, analysts called the rocatinlimab results disappointing, saying the drug needed to show an especially high efficacy profile to counter safety concerns. The Uplizna findings, meanwhile, suggest Amgen has a viable second-line contender to treat myasthenia gravis but likely won’t threaten Argenx’s Vyvgart as a first-line choice, analysts said.”
  • Per MedTech Dive,
    • “Medtronic and Siemens Healthineers have partnered to expand accessto pre- and post-operative imaging technologies for spine surgery, the companies said Wednesday at the North American Spine Society annual meeting. 
    • “The firms will co-market Siemens Healthineers’ Multitom Rax X-ray imaging system and integrate it into Medtronic’s AiBLE suite of products for spine surgery. 
    • “Skip Kiil, Medtronic’s president of cranial and spinal technologies, said in a statement the partnership should reduce variability and improve patient outcomes.”
  • and
    • “Roche launched the first test using the company’s technology to simultaneously detect up to 12 respiratory viruses.
    • “The launch, announced Tuesday, enables users of Roche’s Cobas 5800, 6800 and 8800 molecular diagnostic analyzers to test for pathogens including influenza A and B, RSV and the COVID-19 virus.
    • “The test is available for labs in countries that accept CE marks. Roche plans to file for 510(k) clearance in the U.S. in the fourth quarter. The company is targeting a respiratory molecular diagnostics market that it has predicted will be worth 1.7 billion Swiss francs by 2027, the equivalent of about $2 billion according to Wednesday’s exchange rate.”
  • Beckers Hospital Review identifies the 25 most expensive inpatient drugs, and tells us,
    • “A recent study from Harvard Medical School introduced TxGNN, an innovative AI tool designed to identify potential drug candidates for over 17,000 rare and neglected diseases. 
    • “The research, published in Natural Medicine Sept. 25, found that TxGNN is nearly 50% more effective at identifying drug candidates and 35% more accurate in predicting contraindications than existing methods. 
    • “The model links conditions to existing drugs, both FDA-approved and experimental, by leveraging data on DNA, clinical notes and gene activity. The model also offers insights into potential side effects, potentially speeding up the lengthy drug discovery process. 
    • “TxGNN has been made available for free, encouraging its adoption by clinician-scientists in the search for new therapies.” 
  • The New York Times reports that “Health care systems have been putting therapists’ progress reports online, much to the surprise (and anger) of some patients.”
    • “Starting in 2021, the federal government required all U.S. health care systems to share clinicians’ visit notes electronically, often referred to as open notes, as part of the 21st Century Cures Act. This includes therapy progress notes, which typically provide information about the client’s appearance and mood, a diagnosis, the treatment plan and any progress the client has made toward therapy goals.” * * *
    • “The 21st Century Cures Act allows clinicians to block notes in certain circumstances — for example if there’s a chance that the patient could become suicidal or homicidal after reading it.
    • “Steve O’Neill, a licensed clinical social worker and the director of behavioral health for OpenNotes, the organization at Beth Israel that has pushed for transparency between clinicians and patients, said that he temporarily blocked his notes from a patient who initially became psychotic and holed up in her apartment after reading them.
    • “There needs to be more research, Dr. Blease said, examining whether patients with severe mental illness could experience emotional harm or even self-injury after reading open notes.
    • “Dr. O’Neill has observed that some patients benefit from reading the notes alongside a clinician or in group therapy. It’s important that the patient not feel “ambushed,” he added.

Tuesday Tidbits

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

From Washington, DC,

  • BioPharma Dive tells us,
    • Novo Nordisk’s top executive vowed to reopen price negotiations with insurers covering the company’s obesity and diabetes drugs at a congressional hearing on Tuesday in which lawmakers pressed Novo to lower the cost of the fast-selling medicines.
    • At the hearing, Novo CEO Lars Fruergaard Jørgensen said the company would consider new talks with insurers about the list prices of Wegovy and Ozempic if they follow through on a pledge to keep the medicines on their formularies. Novo has claimed that insurers have previously pulled coverage of its other medicines — such as insulins — once the company lowered list prices, because it resulted in less revenue for payers afterwards.
    • “If it works in a way where patients get access to a more affordable medicine, and we have certainty that it actually happens and not like when we lowered prices in prior rounds — that less people got access to our medicine — we will be positive towards it,” Jørgensen said.” * * *
    • [Senate HELP Committee Chair Bernie] Sanders [I VT] came to the hearing with, what he claimed, is a commitment from Cigna [Express Scripts], UnitedHealth Group [/ Optum Rx] and CVS Health [/ Caremark] to commit to covering the two drugs even if lower list prices lead to lower rebates. The initiative for doing so was the difference in list and after-rebate prices for Wegovy and Ozempic in the U.S. compared to other countries.”
  • Here is a link to the Federal Trade Commission’s public administrative complaint against Express Scripts, Caremark, and Optum Rx over insulin rebates.
  • Per Healthcare Dive,
    • “The chair of the powerful Senate Finance Committee is pressing hospitals on their compliance with federal emergency care law amid mounting reports that patients who need lifesaving abortions are being turned away.
    • “Sen. Ron Wyden, D-Ore., sent letters to eight hospitals in states with abortion restrictions on Monday, asking about policies and procedures they have in place around the Emergency Medical Treatment and Active Labor Act, or EMTALA.
    • “Wyden also asked for a list of personnel involved in deciding when terminating a pregnancy is the appropriate course of treatment, and what legal and human resource support is offered to them by the hospital.”
  • CMS has created a website for its new civil monetary penalty program applicable to Section 111 reporting that will take effect on October 5, 2024, and will hold a compliance webinar on October 15, 2024, at 1 pm ET.
  • Per HHS press releases,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Administration for Strategic Preparedness and Response (ASPR), announced actions to increase the supply of mpox vaccine, supporting the U.S. Government commitment to make over a million combined doses of mpox vaccines available to the global mpox response. This is the largest international donation of the JYNNEOS mpox vaccine to date, which just received regulatory approval from WHO last week.”
  • and
    • “Today, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), announced nearly $75 million to support health care services in rural America. Funding will launch new opioid treatment and recovery services in rural communities, strengthen maternal health care in the South, and help rural hospitals stay open. HRSA Administrator Carole Johnson attended an event yesterday in Wilson, North Carolina, where she discussed the impact of this investment in rural health care.” * * *
    • “For a list of the awards, visit: https://www.hrsa.gov/about/news/fy24-rural-award-announcements“
  • Bloomberg reports,
    • “The Biden administration issued a final rule Tuesday designed to address suspicious billing for durable medical equipment that may have cost the Medicare program more than $2 billion.
    • “The problem involving urinary catheters has disproportionately affected accountable care organizations, the groups of doctors, clinicians, and hospitals that provide coordinated care for beneficiaries in traditional Medicare. 
    • “After detecting the spike in billing in early 2023, the Centers for Medicare & Medicaid Services stopped payment on almost all of the claims and began an investigation.
    • “They found the activity “was attributed to a small group of durable medical equipment supply companies,” and “determined that the beneficiaries did not receive catheters and were not billed directly, physicians did not order these supplies, and supplies were not needed,” said a CMS fact sheet. Since then, the top 15 billers of suspicious catheter claims have had their Medicare enrollment revoked.
    • “The CMS rule (RIN 0938-AV20) excludes payments involving certain billing codes for durable medical equipment from calculations used to assess an ACO’s financial performance in 2023.”

From the public health and medical research front,

  • BioPharma Dive tells us
    • “Obesity drug startup Metsera on Tuesday reported its first clinical data since launching in April with $290 million in venture funding. The data come from a Phase 1 trial of a drug, MET-097, that’s designed to have longer-lasting effects than injectable GLP-1 therapies like Novo Nordisk’s Wegovy. The results show that a weekly administration of the highest dose tested stimulated weight loss of 7.5% over 36 days, “matching, or potentially exceeding,” currently marketed and investigational anti-obesity medications, Metsera chief medical officer Steve Marso said in a statement. Metsera claimed the findings are supportive of once-monthly dosing and will start mid-stage trials in the fourth quarter, with results expected next year.” 
  • Per a National Institutes of Health press release,
    • “Cancer incidence trends in 2021 largely returned to what they were before the COVID-19 pandemic, according to a study by researchers at the National Institutes of Health (NIH). However, there was little evidence of a rebound in incidence that would account for the decline in diagnoses in 2020, when screening and other medical care was disrupted. One exception was breast cancer, where the researchers did see an uptick in diagnoses of advanced-stage disease in 2021. The study appears Sept. 24, 2024, in the Journal of the National Cancer Institute.
    • “A previous study showed that new cancer diagnoses fell abruptly in early 2020, as did the volume of pathology reports, suggesting that many cancers were not being diagnosed in a timely manner. To determine whether these missed diagnoses were caught in 2021, possibly as more advanced cancers, researchers from NIH’s National Cancer Institute (NCI) compared observed cancer incidence rates for 2021 with those expected from pre-pandemic trends using data from NCI’s Surveillance, Epidemiology, and End Results Program.”
    • “A full recovery in cancer incidence should appear as an increase over pre-pandemic levels (also known as a rebound) to account for the missed diagnoses. The researchers looked at cancer overall, as well as five major cancer types that vary in how they are typically detected: through screening (female breast and prostate cancer), due to symptoms (lung and bronchus and pancreatic cancer), or incidentally during other medical procedures (thyroid cancer).
    • “Cancer incidence rates overall and for most specific cancers approached pre-pandemic levels, with no significant rebound to account for the 2020 decline. However, in addition to an uptick in new diagnoses of advanced breast cancer in 2021, the data also provided some evidence of an increase in diagnoses of advanced pancreatic cancer. Also, new diagnoses of thyroid cancers in 2021 were still below pre-pandemic levels.
    • “The researchers concluded that 2021 was a transition year that was still affected by new variants and new waves of COVID-19 cases, which continued to impact medical care. They said the findings highlight the need for ongoing monitoring to understand the long-term impacts of the pandemic on cancer diagnoses and outcomes.”
  • CNN reports,
    • “The US government plans to make more at-home Covid-19 tests available for free this month as the country heads into respiratory virus season with high levels of the coronavirus already circulating.
    • “Each household will be able to order another round of four free at-home test kits starting at the end of September at COVIDTests.gov.
    • “More than 900 million test kits have been delivered directly to US residents through the COVIDTests.gov program, according to the US Department of Health and Human Services.
    • “COVID-19 testing can help you know if you have COVID-19 so you can decide what to do next, like getting treatment to reduce your risk of severe illness and taking steps to lower your chances of spreading the virus to others,” the agency said.
    • “This next set of tests – the program’s seventh round of distribution – will be able to detect currently circulating variants and can be used as people prepare for year-end holiday gatherings.”
  • The Washington Post reports that “Doctors and patients struggle with starting and stopping GLP-1 medications with little guidance.”
  • Per Fierce Pharma,
    • “The FDA is having second thoughts about the broad labels it has granted PD-1 inhibitors in newly diagnosed stomach cancer, questioning whether restrictions should be placed on products from Bristol Myers Squibb and Merck & Co. plus a stomach cancer hopeful from BeiGene.
    • “In a briefing document prepared for an Oncologic Drugs Advisory Committee meeting slated for Thursday, the FDA suggested that PD-1 inhibitors may not be suitable for certain patients with HER2-negative gastric cancer who have low PD-L1 expression, even though these immunotherapies have shown life-extension benefits in broad study populations.”

From the U.S. healthcare business front,

  • The American Hospital Association News reports,
    • “An EY report prepared for the AHA shows that tax-exempt hospitals and health systems delivered $10 in benefits to their communities for every dollar’s worth of federal tax exemption in 2020, the most recent year for which comprehensive data is available. It represents an increase from $9 in benefits from the prior year despite efforts in battling the COVID-19 pandemic.”  
  • Per Business Insurance,
    • “Prudential Financial is re-entering the U.S. stop-loss insurance market, targeting employers with at least 100 employees, offering coverage for medical, prescription drug, dental, vision, and short-term disability claims, BenefitsPro reports. Prudential aims to leverage its experience under the leadership of Jessica Gillespie, who is head of Prudential’s group insurance products. The stop-loss market has seen significant price hikes, with some competitors dissatisfied with their financial outcomes.”
  • and
    • “Health insurance companies are increasingly covering prescriptions written by pharmacists as states expand pharmacists’ prescribing authority through “test to treat” legislation, Forbes reports. This shift aims to improve access to medications amid a shortage of primary care physicians. Major insurers like Cigna and Blue Cross and Blue Shield of Illinois are adapting their coverage policies accordingly.”
  • The New York Times reports
    • “Every day, patients send hundreds of thousands of messages to their doctors through MyChart, a communications platform that is nearly ubiquitous in U.S. hospitals.
    • “They describe their pain and divulge their symptoms — the texture of their rashes, the color of their stool — trusting the doctor on the other end to advise them. 
    • “But increasingly, the responses to those messages are not written by the doctor — at least, not entirely. About 15,000 doctors and assistants at more than 150 health systems are using a new artificial intelligence feature in MyChart to draft replies to such messages.
    • “Many patients receiving those replies have no idea that they were written with the help of artificial intelligence. In interviews, officials at several health systems using MyChart’s tool acknowledged that they do not disclose that the messages contain A.I.-generated content.
    • “The trend troubles some experts who worry that doctors may not be vigilant enough to catch potentially dangerous errors in medically significant messages drafted by A.I.”

Monday Roundup

David Ermer–CMS, Congress, Electronic health records, FDA, Medical / Rx research, Mental health care, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The House of Representatives and the Senate are in session this week for Committee business and floor voting. The members of Congress hit the campaign trail next week until they return to Capitol Hill in November following the national election for a lame duck session.
  • Per an HHS press release,
    • “In its ongoing commitment to support women’s health, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), today launched an innovative grant program to provide almost $9 million to improve women’s health coverage and access to critical health benefits. These funds may be used to develop activities and launch educational campaigns to address disparities in access to reproductive health care and maternal health outcomes – many of which often result from challenges women face when trying to access information about available benefits or coverage, including for contraception and other family planning services. The Expanding Access to Women’s Health program grantees include the District of Columbia and the following 14 states: Arkansas, Colorado, Hawaii, Massachusetts, Maine, Mississippi, Nebraska, New Hampshire, New Jersey, New Mexico, Pennsylvania, Vermont, Washington, and Wisconsin.”
  • Modern Healthcare reports,
    • “Fewer hospitals will face high readmissions penalties in 2025 as rates of reimbursement cuts stabilize for providers.
    • “It is the third consecutive year in which the percentage of hospitals assessed penalties of 1% or more moderated, according to preliminary data released Friday by the Centers for Medicare and Medicaid Services. Penalties reduce the Medicare fee-for-service payments CMS makes to hospitals.
    • “For fiscal 2025, the number of hospitals included in the agency’s Hospital Readmissions Reduction Program is the lowest it has been in five years, with 100 fewer facilities participating than in fiscal 2021.
    • “The hospital readmissions performance period for fiscal 2025 pulls in claims from July 2020 through June 2023. The report is based on a rolling three-year time period, so the most recent one is the first to only include data generated after the start of the COVID-19 pandemic.”
  • FiercePharma tells us,
    • “For trade group the Pharmaceutical Research and Manufacturers of America (PhRMA), the fight against pricing provisions in the Inflation Reduction Act isn’t over yet.
    • “Late last week, the U.S. Court of Appeals for the Fifth Circuit reversed (PDF) a previous dismissal of PhRMA’s Inflation Reduction Act (IRA) lawsuit from February [2024 for lack of standing and proper venue], punting the complaint back to a lower Texas court.
  • and
    • “Less than a year after snagging its first FDA approval in psoriasis, UCB’s blockbuster hopeful Bimzelx has picked up three more indications to add to its growing resume of inflammatory disease treatment.
    • “The FDA cleared Bimzelx to treat adults with active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS). The med is the first IL-17A/F inhibitor approved to treat the three indications, UCB noted in a press release.”

From the public health and medical research front,

  • The Washington Post informs us,
    • “About 37 percent of Gen Z men in the United States do not have an established primary care provider, according to a recent survey from the Cleveland Clinic. The survey, conducted this summer, involved 1,000 American men 18 or older living in the continental United States.
    • “Researchers assessed how different generations of men responded to questions about their health and health care, including whether they obtain yearly physicals, get screened based on doctors’ recommendations, and avoid smoking or vaping.
    • “The 37 percent of adult Gen Z men (born from 1997 through 2005) without a regular primary care provider compared with 27 percent of millennials (born from 1981 through 1996), 17 percent of Gen X respondents (1965 to 1980) and 7 percent of baby boomers and older (born before 1965).
    • “Nearly all the respondents said living a healthy lifestyle was a top priority, and 87 percent were concerned about how their current health habits would affect their future health. Millennials and adult Gen Zers were more likely to take care of their mental health (59 percent) than Gen X and boomers (53 percent), according to the survey.”
  • Consumer Reports, writing in The Washington Posts, offers tips on how to alleviate hip pain.
  • STAT News informs us,
    • “Of the roughly 15 million Americans who tried to quit smoking in 2022, 5 in 6 failed. It’s a jarring statistic — and an indictment of the treatment options for an addiction that kills 480,000 people in the U.S. each year.
    • “The smoking-cessation drugs on the market don’t work well for the majority of people, and they come with side effects and reputations that keep some smokers from ever trying them. Despite this, there hasn’t been a new class of drug approved for the condition in nearly two decades.” * * * 
    • “Chantix increases smokers’ success at quitting when compared to a placebo — but for every 100 people who use it, just 21 to 25 successfully stop, a recent meta-analysis found. It’s also associated with a raft of side effects, ranging from nausea to vivid dreams. Chantix, also known by its chemical name, varenicline, went generic in 2021 and can be purchased without insurance for roughly $68 for a one month supply, according to GoodRx.”  * * *
    • “In 2019, GlaxoSmithKline wrote to the FDA urging the agency to take several steps that would align its approach toward regulating NRT products with other nations’. Specifically, the drugmaker requested that the agency embrace a “Reduce to Quit” approach, whereby smokers are encouraged to use products like nicotine gum as they gradually reduce their cigarette consumption. 
    • “While the FDA has said it is open to this approach, which is used in countries like Germany, Canada, and the United Kingdom, the agency issued a guidance last year instructing drugmakers they would need to conduct a trial to evaluate the proposed regimen. GSK has warned that the need for another study “will make it less likely for innovator companies to pursue this indication in the U.S.”
  • Per KFF,
    • “A new KFF analysis examines the recent decline in opioid overdose deaths, with a focus on how trends vary by age, race, gender and state.
    • “Provisional data from the Centers for Disease Control and Prevention show a 20% decline in deaths during the latter half of 2023 compared to the same period from the previous year.
    • “In the second half of 2023, White people saw the largest decline (-14%) in opioid overdose deaths while declines among Black people were about half that (-6%), compared to the same period the year before.
    • “All age groups experienced declines in opioid overdose deaths except one. Among people 65 and older, opioid deaths rose by 9% percent in late 2023, with factors such as low detection of substance use concerns potentially playing a role.
    • “In three-quarters of states, opioid deaths declined in the last six months of 2023 compared to the same period in 2022. In 2023, opioid death rates were the highest in West Virginia, Washington D.C. and Delaware, while states with the lowest opioid death rates included Nebraska, South Dakota and Iowa.
    • “Newer provisional and partial data for the first quarter of 2024, which is not included in this analysis, point to a continuation of the overall downward trend in opioid overdose deaths through early 2024.”

From the U.S. healthcare business front,

  • Managed Healthcare Executive points out,
    • “Employers expect prescription drug costs to increase an average of 8% in 2025, making prices the highest they’ve been in 15 years, according to a news release published yesterday. Data was taken from the results of the 2025 Segal Health Plan Cost Trend Survey, an annual survey of managed care organizations, health insurers, prescription drug benefit managers (PBMs) and third party administrators (TPAs). Price inflation is the biggest factor on medical costs.
    • “Respondents predict that the highest rates will be reflected in all outpatient prescription drugs with an 11.4% increase, up from last year’s projected rate of 9.9%, calculated before PBM rebates. Outpatient prescription drugs trends are affected by factors such as drug price inflation, direct-to-consumer advertising and a changing drug mix.
    • “The increased use of drugs with the glucagon-like peptide 1 (GLP-1s) is a driving force in drug prices, due to their effectiveness in treating both type 2 diabetes and obesity, the survey reports. In 2023, obesity management was the top medical condition driving costs at 255.3%, followed by migraines at 31.4%.”
  • Per Fierce Healthcare,
    • “What began as a dispute between two health tech companies over healthcare data exchange practices has now led to a federal lawsuit alleging antitrust violations.
    • “Venture-backed health tech company Particle Health filed an antitrust lawsuit against Epic in the Southern District of New York alleging that the electronic health records (EHR) giant is trying to muscle out competition in the payer platform market.
    • “The 81-page lawsuit (PDF), filed today [in the U.S. District Court for the Southern District of New York], alleges Epic engaged in monopolistic, anti-competitive practices, using its “power over EHRs to expand its dominance into the fledgling market for payer platforms,” according to the lawsuit, which was reviewed by Fierce Healthcare.
    • “Particle Health argues in its federal complaint that Epic has not only engaged in anticompetitive behavior but has purposefully blocked the exchange of patient information.
    • “In an emailed response to Fierce Healthcare, an Epic spokesperson said Particle’s claims are baseless.”
  • MedTech Dive lets us know,
    • “Stryker has struck its fourth takeover in as many months, acquiring Nico Corporation to add minimally invasive solutions for brain tumor removal and stroke care to its portfolio.
    • “Nico sells devices for navigating through the brain, visualizing the organ, removing tumors and clots and collecting tissue. The company received clearance for a device that allows visualization of the surgical field during brain surgery in 2012 and has since expanded its portfolio.
    • “Stryker will slot the products into a neurocranial business that reported U.S. organic sales growth of almost 11% in the second quarter. Specifically, the devices will form part of a neurosurgical unit that Stryker called out as a growth driver in the fourth quarter of 2023. Stryker did not disclose the terms of the deal.”

Weekend Update

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, Rx coverage, U.S. Healthcare–

Happy first day of Fall 2024!

From Washington, DC,

  • The Wall Street Journal reports,
    • “House Republican leaders on Sunday unveiled a bipartisan spending deal that would keep the government open for three more months and give the Secret Service an extra $231 million to help the agency to protect presidential candidates during the final hectic weeks of election season. 
    • “Secret Service officials have faced questions on whether a lack of resources contributed to the security lapses that enabled a gunman to shoot Republican presidential nominee Donald Trump in the ear during a campaign rally in Butler, Pa., in July. Secret Service agents stopped a second apparent assassination attempt on Trump at his Florida golf course last weekend.
    • “The additional money wouldn’t be available until the agency transmits a report on the first assassination attempt to a bipartisan task force investigating the incident. It would also give Secret Service officials the flexibility to move around money within the agency to accommodate demand through the end of the year. Leaders of both parties and President Biden have said that they are open to sending additional money to the agency.” 
  • Federal News Network informs us,
    • “Legislation to repeal the Windfall Elimination Provision and the Government Pension Offset is nearing the finish line in the House.
    • “Just over a week after it was filed, a discharge petition for the Social Security Fairness Act has reached the 218-signature threshold needed to force the bill to a floor vote.”
  • FedWeek adds,
    • “Repealing the government pension offset and windfall elimination provisions would benefit those affected by those two Social Security reductions—including current and future federal retirees under the CSRS system—by a total of $196 billion over 10 years, says a cost estimate for Congress.
    • “But that also means passage would increase costs by that much to that already financially troubled system, the Congressional Budget Office said in an estimate whose price tag may complicate the current push to enact that long-standing proposal this year.”
  • The new mental health parity rule has been published in a complete and more compact form in the Federal Register.

From the public health and medical research front,

  • STAT News lets us know,
    • “A second health worker who cared for a person hospitalized in Missouri with H5N1 bird flu developed mild respiratory symptoms but was not tested for influenza, the Centers for Disease Control and Prevention reported on Friday.
    • “The CDC said Missouri health officials didn’t learn that the health worker had symptoms until after the individual had recovered, too late to run a diagnostic test.
    • “CDC is in close communication with the state of Missouri in its ongoing investigation into the positive H5N1 case there, including regarding the identification of an additional symptomatic close contact,” a spokesperson for the agency told STAT via email. “The finding does not change CDC’s assessment that the risk to the public remains low.” * * *
    • “The CDC said that the newly identified health worker will also be asked to submit a blood sample for testing. Asked if the health care workers have agreed to provide blood samples for antibody testing, Cox said: “We should know more next week.”
    • “Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy, said there could be another explanation for this health care worker’s illness. At the time the confirmed case was in hospital, there was a lot of respiratory illness, including high levels of Covid-19 activity.
    • “We’ll have to see what the serology shows,” Osterholm said. 
    • “This news emerged as California announced it had found seven more infected dairy herds, bringing the number of affected farms in the state to 17, and the cumulative number of infected herds in the country to 215 in 14 states. The outbreak in cattle was first confirmed in late March.”
  • The Washington Post points out,
    • “Immigration status, structural racism and other social factors may contribute to disparities in cardiovascular health among Asian Americans, according to a statement prepared by a group of clinicians and researchers and published in the American Heart Association journal, Circulation.
    • “Asian Americans are less likely than White adults to have or die of heart disease, according to the Department of Health and Human Services Office of Minority Health. But researchers in the Circulation article note that cardiovascular health can vary widely between subgroups of Asian Americans and warn that combining different subgroups of people into a single “Asian” category could mask important differences.
    • “A 2021 Pew Research Center analysis of federal census data found that the number of Asian Americans grew 81 percent between 2000 and 2019, making it the nation’s fastest-growing racial group. Yet the term includes people from different subgroups, including Chinese, Indian, Filipino, Vietnamese, Korean and Japanese Americans.”
  • Per BioPharma Dive,
    • “Roche’s antiviral drug Xofluza reduced influenza transmission among household contacts in a large Phase 3 study, the company said Wednesday.
    • “Treatment with a single dose of Xofluza within 48 hours of symptom onset lowered the likelihood an infected person passed on the virus to other individuals within the same household. Roche didn’t disclose detailed results in its press release.
    • “Xofluza is currently approved to treat flu symptoms and prevent infections after exposure to the virus. The new data bolster its benefits and, according to Roche, represent the first time an antiviral drug has reduced transmission of a respiratory virus in a global Phase 3 study.”
  • MedPage Today discusses how GLP-1 drugs have the potential to reduce healthcare costs in unexpected ways.

From the U.S. healthcare business front,

  • Modern Health tells us,
    • “Cardinal Health plans to acquire Integrated Oncology Network for $1.12 billion in cash.
    • “The transaction is subject to regulatory approval and expected to close later this year, a Cardinal spokesperson said.
    • “As part of the deal, Nashville, Tennessee-based Integrated Oncology would join Cardinal’s oncology practice alliance, Navista, and share resources for practice management services, analytics capabilities and artificial intelligence tools, according to a Friday news release.
    • “Integrated Oncology has more than 50 practice sites in 10 states and represents more than 100 providers, offering medical oncology, radiation, diagnostic testing and other services.
    • “Dublin, Ohio-headquartered Cardinal, a pharmaceutical distributor and medical product manufacturer, has about 48,000 employees operating facilities in more than 30 countries. In March, the company acquired multispecialty group purchasing organization Specialty Networks for $1.2 billion in cash.”
  • Per Healthcare Dive,
    • “Cigna is the latest health insurer to roll back its Medicare Advantage offerings next year, as the privately run Medicare plans look for ways to preserve profits amid higher costs from more seniors utilizing medical care.
    • “Cigna’s planned reductions will affect 36 plans in eight states, and include the insurer exiting at least three counties entirely, according to a notice to marketing agents published by Pinnacle Financial Services on Wednesday.
    • “However, the majority of those plans have low membership, and patients in most markets will have access to another Cigna MA plan, according to the notice.”
  • Per Fierce Pharma,
    • “Since an initial FDA go-ahead in 2020, Sanofi’s Sarclisa has been specifically approved for patients with previously treated multiple myeloma. That changed Friday.
    • “The FDA has approved Sarclisa to be used in combination with bortezomib, lenalidomide and dexamethasone (VRd) to treat patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplant.
    • “With the expansion, Sarclisa stands to give Johnson & Johnson’s Darzalex some company in the indication. Since 2018, the J&J med has been the lone CD38 antibody approved for first-line myeloma. For that Darzalex approval, the FDA cleared the med to be paired with bortezomib, melphalan and prednisone, also for transplant-ineligible patients. That Darzalex regimen is considered outdated and not used very often these days.
    • “Before the latest FDA approval, Sarclisa-VRd was recently added to the National Comprehensive Cancer Network (NCCN) myeloma treatment guidelines as a preferred regimen for transplant-ineligible patients, along with VRd alone and a Darzalex-Rd combo. All three regimens bear the highest category 1 recommendation.
    • “We’re getting access to the biggest segment of this market, and we are leveling the playing field in a major class of drug,” Olivier Nataf, Sanofi’s global head of oncology, said in a recent interview with Fierce Pharma.”