Monday Roundup

Monday Roundup

Photo by Sven Read on Unsplash

From Washington, DC

  • Roll Call reports,
    • “Lawmakers are back to writing a full-year fiscal 2024 Homeland Security appropriations bill in a dramatic, last-minute shift following White House intervention over the weekend, sources familiar with the decision said Sunday night. 
    • “Appropriators had been working on a yearlong stopgap measure, negotiating necessary changes to the fiscal 2023 status quo to be included as “anomalies,” after talks on a full-year bill initially fell apart late last week. * * *
    • “While the situation remains fluid, the move back toward a full-fledged bill is ultimately a sign of forward momentum. However, release of text for the complete six-bill package is now expected Monday at the earliest, putting Congress on a compressed timeline to clear the legislation before Friday at midnight, when current stopgap funding lapses.
    • “House rules allot members 72 hours to read legislation before voting on it, and it usually takes the Senate a couple days to process any legislation. The package will also include the Defense, Labor-HHS-Education, Financial Services, Legislative Branch and State-Foreign Operations measures.” 
  • The White House issued an Executive Order on Advancing Women’s Health Research and Innovation. Here is a link to the White House fact sheet.
    • “Today, President Biden is signing a new Executive Order that will direct the most comprehensive set of executive actions ever taken to expand and improve research on women’s health. These directives will ensure women’s health is integrated and prioritized across the federal research portfolio and budget, and will galvanize new research on a wide range of topics, including women’s midlife health.”
  • The White House also announced,
    • “President Biden’s Cancer Moonshot is accelerating progress to prevent, detect, and treat cancer while boosting support for families facing cancer, including by undertaking an aggressive effort to protect families and workers from hazardous chemicals like known carcinogens. After more than three decades of inadequate protections, today the Environmental Protection Agency (EPA) is announcing a historic ban on ongoing uses of asbestos. This marks the first rule finalized under the nation’s updated chemical safety law, a milestone in the Biden-Harris Administration’s efforts to protect public health, advance environmental justice, and end cancer as we know it.”

From the Food and Drug Administration front,

  • The FDA informed us,
    • “Today, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD). 
    • “Metachromatic leukodystrophy is a debilitating, rare genetic disease affecting the brain and nervous system. It is caused by a deficiency of an enzyme called arylsulfatase A (ARSA), leading to a buildup of sulfatides (fatty substances) in the cells. This buildup causes damage to the central and peripheral nervous system, manifesting with loss of motor and cognitive function and early death. It is estimated that MLD affects one in every 40,000 individuals in the United States. There is no cure for MLD, and treatment typically focuses on supportive care and symptom management.”
  • MPR reports,
    • “The Food and Drug Administration (FDA) has approved Xhance® (fluticasone propionate) nasal spray for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older. Previously, the treatment was only approved for adults with nasal polyps.
    • Xhance is a drug-device combination therapy that delivers fluticasone, a corticosteroid, deep into difficult-to-access sinuses and sinonasal drainage tracts. The medication is delivered into the nose by actuating the pump spray into 1 nostril while simultaneously blowing (exhaling) into the mouthpiece of the device.”

From the public health and medical research front,

  • MedPage tells us,
    • “Preventing SARS-CoV-2 infection in immunocompromised people hasn’t gotten any easier as the pandemic trundles on into its fifth year. * * *
    • “Vaccination against SARS-CoV-2 is now the key prevention strategy for this vulnerable population, and people who are immunocompromised should still get COVID boosters — but, given that they are less likely to generate an adequate immune response to the vaccines, the question is: how often? * * *
    • “Of three clinicians who treat moderately to severely immunocompromised patients and spoke with MedPage Today, all of them offered a similar recommendation: people who are immunocompromised should get a COVID vaccine about every 6 months, with the caveat that intervals between vaccine doses should be tailored to individual patient needs.”
  • and
    • “Electronic nudges sent to patients failed to increase influenza vaccine uptake in one randomized clinical trial, while another trial found that slight increases in vaccination rates from letters emailed to patients failed to impact clinical outcomes.
    • “Neither portal nor text messages to remind patients to get an influenza vaccination were effective at a population level at improving vaccination uptake, Peter Szilagyi, MD, MPH, of the UCLA Mattel Children’s Hospital at the University of California in Los Angeles, and colleagues reported in JAMA Internal Medicine. Among patients who received care from 79 primary care practices in a large healthcare system, flu shot rates remained at approximately 47% whether patients received portal messages, text messages, or no reminders at all.
    • “And in an analysis of the Danish NUDGE-FLU trial, an about 1% boost in influenza vaccination associated with email letters encouraging patients to get vaccinated did not translate into improvements in cardiovascular, respiratory, or other clinical endpoints, Niklas Johansen, MD, of the Copenhagen University Hospital-Harlev and Gentofte in Denmark, and colleagues wrote in the Annals of Internal Medicine
  • Healio lets us know,
    • “A CDC program to distribute free HIV self-test kits has mailed nearly double the number of tests in its first year than expected.
    • “More than one-quarter of people receiving tests had never tested for HIV before.”
  • The National Institutes of Health announced,
    • “Using advanced imaging techniques and in-depth clinical assessments, a research team at the National Institutes of Health (NIH) found no significant evidence of MRI-detectable brain injury, nor differences in most clinical measures compared to controls, among a group of federal employees who experienced anomalous health incidents (AHIs). These incidents, including hearing noise and experiencing head pressure followed by headache, dizziness, cognitive dysfunction and other symptoms, have been described in the news media as “Havana Syndrome” since U.S. government personnel stationed in Havana first reported the incidents. Scientists at the NIH Clinical Center conducted the research over the course of nearly five years and published their findings in two papers in JAMA today.
    • “Our goal was to conduct thorough, objective and reproducible evaluations to see if we could identify structural brain or biological differences in people who reported AHIs,” said Leighton Chan, M.D., chief, rehabilitation medicine and acting chief scientific officer, NIH Clinical Center, and lead author on one of the papers. “While we did not identify significant differences in participants with AHIs, it’s important to acknowledge that these symptoms are very real, cause significant disruption in the lives of those affected and can be quite prolonged, disabling and difficult to treat.”
  • and
    • “Fenoprofen, a nonsteroidal anti-inflammatory drug (NSAID), successfully alleviated pain and inflammation in a rodent model of endometriosis, according to researchers funded by the National Institutes of Health (NIH). They chose the drug after using a computer algorithm to evaluate nearly 1,300 existing compounds for their ability to reverse gene expression related to endometriosis disease. The study was funded by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
    • “Analysis by researchers at the University of California, San Francisco, using publicly available data from people with endometriosis, returned 299 candidate compounds with seven considered top candidates. These drugs included commonly used treatments for the disease, such as aspirin, as well as those not yet studied for this purpose. The researchers chose fenoprofen for further evaluation because it returned the highest gene expression reversal score and belongs to a drug class—NSAIDS—that is one of the first-line treatments for endometriosis.
    • “Fenoprofen is a prescription drug approved for the relief of mild to moderate pain and is often prescribed for arthritis. The researchers analyzed electronic medical records from five University of California healthcare institutions and found that the drug had been prescribed for less than 1% of patients with endometriosis or related conditions. They then tested fenoprofen in a rodent model of the disease, observing that it successfully alleviated vaginal hyperalgesia, a surrogate marker for endometriosis-related pain.
    • “If future studies in people confirm these findings, the researchers suggest that fenoprofen could be prescribed more frequently to treat endometriosis pain. Their work also supports continued use of their computer-based approach to repurpose other existing drugs as potential therapeutic candidates for endometriosis.”

From the U.S. healthcare business front,

  • Beckers Hospital Review updates us on the Change Healthcare situation. UHC updated its Change Healthcare cyberattack response website today.
  • The Washington Post considers whether the millions of dollars that Medicare pays for remote vital signs monitoring is worthwhile.
    • “While some small studies show remote monitoring can improve patient outcomes, researchers say it is unclear which patients are helped most and how long they need to be monitored.
    • “The research evidence is not as robust as we would like to show that it is beneficial,” said Ateev Mehrotra, a Harvard Medical School researcher.
    • A January report by the Bipartisan Policy Center, a D.C. think tank, warned about “a lack of robust evidence on the optimal use of remote monitoring” and said some policy and medical experts “question whether we are effectively ‘rightsizing’ the use of these services, ensuring access for patients who need it most, and spending health care dollars in effective ways.”
  • Beckers Hospital Review lets us know the fifteen best and worst states for doctors.
    • “Montana, South Dakota and Nebraska are the top three states for physicians to practice in the U.S., according to WalletHub’s 2024 ranking published March 18. Hawaii, Rhode Island and New Jersey were deemed the worst.
    • “The annual ranking is based on two key dimensions: opportunity and competition, and medical environment.”
  • Per Fierce Healthcare,
    • “Highmark Health recorded $27.1 billion in revenue and a net income of $533 million for 2023, the company announced during its fourth-quarter results Monday.
    • “The company reported an operating margin of $338 million, though there was an operating loss of of $117 million during 2023 for the Allegheny Health Network as the system recovers from the pandemic. That was offset by gains seen in health insurance and other investments.
    • “According to a press release, Highmark holds $11 billion in cash and investments, and Highmark Health Plans reported an operating gain of approximately $400 million in 2023. It remains the largest insurer in Pennsylvania, Delaware, Virginia and western New York, said CEO David Holmberg. It was also selected to provide Medicaid to eligible members in West Virginia.
    • “He said Highmark’s annual revenue has grown 72% and Highmark Health Plan’s membership has grown 32% since 2013.
    • “We have transformed from a successful regional insurer into an innovative, diversified health organization, comprehensive solutions and national influence,” he said.”
  • The Washington Post relates,
    • “AstraZeneca is capping out-of-pocket costs for inhalers and related medication at no more than $35 per month, the drugmaker announced Monday.
    • “The Britain based pharma giant said the expanded savings are intended to help vulnerable patients with asthma or chronic obstructive pulmonary disease, especially those without health insurance. The price cap takes effect June 1.”
  • Beckers Hospital Review adds,
    • “First-time prescriptions for Eli Lilly’s Zepbound surpassed those for Novo Nordisk’s Wegovy in early March, according to data cited by Reuters
    • “For the week ending March 8, 77,590 new prescriptions were filled for Zepbound and about 71,000 were filled for Wegovy. It’s the first time Zepbound, a chronic weight management therapy approved in early November and released in December, eclipsed Novo Nordisk’s blockbuster weight loss drug.” 

Midweek update

Photo by Manasvita S on Unsplash
  • Roll Call informs us,
    • “Congressional leaders reached an agreement on final fiscal 2024 appropriations bills Wednesday that will pave the way for lawmakers to wrap up the process in two packages in the coming days and weeks, sources familiar with the deal said.
    • “Funding for agencies covered by the Agriculture, Energy-Water, Military Construction-VA and Transportation-HUD bills would be extended from March 1 through March 8, joining the Interior-Enviroment and Commerce-Justice-Science bills in the first tranche. Lawmakers are expected to release text of the stopgap spending measure as soon as Wednesday.
    • “Appropriators are aiming for text for the first tranche by Sunday in order for the House to be able to turn around and vote Wednesday, before Thursday gets swallowed up by President Joe Biden’s State of the Union address. In theory, that would give the Senate time to get the first package to Biden’s desk before the impacts of a partial shutdown on those agencies subject to the new March 8 deadline are felt.
    • “Stopgap funding for the remaining six bills, which had been set to lapse March 9, would last through March 22, giving lawmakers enough time to finish turning the deal into legislative text and getting them through both chambers. That package will consist of the Defense, Labor-HHS-Education, Homeland Security, Financial Services, State-Foreign Operations and Legislative Branch measures.” (FEHBlog note — FEHB appropriations are included in the Financial Services bill.]
  • and
    • “Mitch McConnell’s announcement [today] that he will voluntarily end his record-setting reign as Senate Republican leader drew praise and some derision Wednesday, as a contest to succeed him that was already underway began to move out from behind the scenes.
    • “Potential candidates to replace McConnell include the “three Johns,” as they’re known, who have all served as deputies under McConnell in recent years. South Dakota Sen. John Thune, currently the No. 2 Senate Republican; Wyoming Sen. John Barrasso, the current conference chair; and Texas Sen. John Cornyn, a former GOP whip who termed out of leadership, could all make a run for party leader.” 
  • The Bipartisan Policy Center adds,
    • “An additional factor affecting FY2024, which runs from October 1, 2023, through September 30, 2024, and FY2025 is the Fiscal Responsibility Act or FRA—the bipartisan debt limit deal that set discretionary spending levels for two years. The FRA includes a provision that reduces spending caps in the deal and enforces a sequester (an across-the-board cut) if one or more agencies are covered by a CR after April 30, 2024. There is some uncertainty over whether a full-year CR would trigger this April 30 provision. The executive branch’s Office of Management and Budget (OMB) is ultimately responsible for making that decision.”
  • STAT News reports,
    • “In a bid to combat prescription drug costs, the White House will hold a listening session on Monday in search of ways to reform pharmacy benefit managers, according to people familiar with the plans.
    • “The list of attendees includes representatives from the federal government and industry, who are expected to provide insights into how the largest pharmacy benefit managers determine which medicines are covered by insurers and employers, as well as prices that are paid at pharmacy counters. Critics say these middlemen rely on an opaque process that drives up costs for patients and taxpayers.
    • “Among those invited is Mark Cuban, whose Cost Plus Drug Company is trying to transform the marketplace by avoiding the largest middlemen when reaching benefits agreements with employers. He will “just convey what our experience has been at Cost Plus and, if they ask, [make] suggestions on what we think can make things better,” he told us when asked about his expectations for the meeting.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “Centers for Disease Control and Prevention Director Mandy Cohen, M.D., Feb. 28 endorsed a recommendation by its Advisory Committee on Immunization Practices that adults ages 65 years and older receive an additional updated 2023-2024 COVID-19 vaccine dose. 
    • “Today’s recommendation allows older adults to receive an additional dose of this season’s COVID-19 vaccine to provide added protection,” Cohen said. “Most COVID-19 deaths and hospitalizations last year were among people 65 years and older. An additional vaccine dose can provide added protection that may have decreased over time for those at highest risk.”
    • “CDC continues to recommend that everyone stay up to date on their COVID-19 vaccines, especially people with weakened immune systems.”
  • The Wall Street Journal adds,
    • “The CDC’s final decision ensures most health plans cover the inoculations without an out-of-pocket charge when furnished in-network].
    • “Most Covid-19 deaths and hospitalizations last year were among people 65 years and older. An additional vaccine dose can provide added protection that may have decreased over time for those at highest risk,” CDC Director Dr. Mandy Cohen said.”
  • The National Institutes of Health announced,
    • “Frequent cannabis smoking may significantly increase a person’s risk for heart attack and stroke, according to an observational study supported by the National Institutes of Health. The study, published in the Journal of the American Heart Association, uses data from nearly 435,000 American adults, and is among the largest ever to explore the relationship between cannabis and cardiovascular events.   
    • “The study, funded by the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, found that daily use of cannabis — predominately through smoking — was associated with a 25% increased likelihood of heart attack and a 42% increased likelihood of stroke when compared to non-use of the drug. Less frequent use was also associated with an increased risk of cardiovascular events. Weekly users showed a 3% increased likelihood of heart attack and a 5% increased likelihood of stroke.
    • “Around 75% of the study respondents reported that they mainly used cannabis by smoking the drug. Approximately 25% of the respondents reported using cannabis by some method other than smoking, such as vaping, drinking, or eating the drug.
    • “We know that toxins are released when cannabis is burned, similar to those found in tobacco smoke,” said corresponding author Abra Jeffers, Ph.D., a data analyst at Massachusetts General Hospital in Boston and formerly a researcher at the Center for Tobacco Control Research and Education at the University of California, San Francisco, where she conducted the study as part of her postdoctoral work.
    • “We’ve known for a long time that smoking tobacco is linked to heart disease, and this study is evidence that smoking cannabis appears to also be a risk factor for cardiovascular disease, which is the leading cause of death in the United States,” Jeffers said. “Cannabis use could be an important, underappreciated source of heart disease.”
  • MedPage Today lets us know,
    • “Mortality from colorectal cancer (CRC) decreased significantly in patients who were offered early screening with fecal occult blood testing (FOBT), a large prospective cohort study showed.
    • “Cancer-specific mortality decreased significantly by 14% in patients who underwent early screening for CRC, as compared with a control group that received late or no invitations to participate in screening. Excess mortality decreased by 16% in the exposure group.
    • “The results probably underestimated the true impact of screening with FOBT, as some participants in the control group underwent testing, reported Johannes Blom, MD, PhD, of the Karolinska Institutet in Stockholm, and co-authors in JAMA Network Openopens in a new tab or windowClinicians and patients now have greater confidence that CRC screening reduces the risk of dying of CRC.”
  • The Society for Human Resource Management offers ten tips to Support Mental Health in Multigenerational Workplaces.”
  • MedTech Dive informs us,
    • “Johnson & Johnson has started patient enrollment in a pivotal trial to evaluate its Laminar left atrial appendage (LAA) elimination device for reducing stroke risk due to blood clot formation in the heart, the company said Tuesday.
    • “The investigational device exemption study will enroll 1,500 patients with atrial fibrillation (AFib), a common form of irregular heart rhythm, at up to 100 U.S. sites.
    • “J&J, which acquired privately held Laminar for $400 million in November, is among the medtech companies aiming to challenge Boston Scientific, whose Watchman implant leads the fast-growing market for LAA devices.” 

From the U.S. healthcare business front,

  • Beckers Hospital Review lists the 43 U.S. hospitals listed in Newsweeks top 250 hospital worldwide. U.S. hospital form four of the top five.
    • 1. Mayo Clinic-Rochester (Minn.)
    • 2. Cleveland Clinic
    • 4. The Johns Hopkins Hospital (Baltimore)
    • 5. Massachusetts General Hospital (Boston)
  • Per Healthcare Dive,
    • “Universal Health Services is guiding to a stronger 2024 than analysts had expected after beating Wall Street’s revenue expectations in fourth-quarter results released Tuesday.
    • “The massive for-profit hospital operator expects to bring in revenue between $15.4 billion and $15.7 billion this year, which represents almost 9% year-over-year growth at the midpoint. In comparison, UHS grew revenue almost 7% last year, ending 2023 with $14.3 billion. The system’s profit was $717.8 million, up 6%.
    • “UHS was helped in the fourth quarter from better-than-expected behavioral health volumes, despite continued cost pressures from physician subsidy expenses and the ongoing Medicaid redetermination process.”
  • Per Fierce Healthcare,
    • “Danbury, Connecticut-based Nuvance Health is joining Northwell Health, New York’s largest provider and private employer, under a strategic merger agreement unveiled Wednesday.
    • “The deal, which still requires regulatory signoffs, would create a healthcare network of more than 28 hospitals, over 1,000 care sites, nearly 100,000 staff and 14,500 employed providers, the two nonprofits said in their joint announcement.
    • “This partnership opens a new and exciting chapter for Northwell and Nuvance and provides an incredible opportunity to enhance both health systems and take patient care and services to an even higher level,” Michael Dowling, president and CEO of Northwell Health said in the announcement. “We have similar missions in providing high-quality care for patients in the communities we serve. We look forward to building on the care that Nuvance Health’s 14,000 staff members and providers deliver each and every day.”
  • Health Equity explains why employer matching contributions to employee health savings accounts can be game changer when trying to lower healthcare costs.
    • “When implementing an HSA contribution plan, it’s helpful to structure the program in a way that is not only cost-effective but also encourages adoption. Seed options are a good way to encourage HSA use because they directly help employees with healthcare costs. You can make seed contributions in several ways, such as:
      • A lump sum
      • Smaller amounts throughout the year
      • Or a combination of both tactics
    • “To boost adoption, consider offering an HSA-qualified plan with lower premiums than your regular plan. This way, the choices cost about the same. For instance, you could offer a PPO plan with a $400 monthly premium or an HSA-qualified plan with a $200 monthly premium and an extra $200 monthly employer seed.
    • “It’s not uncommon for organizations to seed the first year of an employee’s HSA to help them transition into the plan, but few make the important switch to a match system to continue encouraging contributions.
    • “According to HealthEquity research, only 12% of employers provide a contribution match compared to 68% who offer a seed.”

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Congressional leaders emerged from the White House on Tuesday optimistic about avoiding a partial shutdown of several departments and agencies — after a meeting with President Joe Biden that also focused on the importance of aid to Ukraine.
    • “The speaker said unequivocally he wants to avoid a government shutdown,” Senate Majority Leader Charles E. Schumer, D-N.Y., told reporters outside the West Wing, adding he did not believe differences on domestic spending were insurmountable.
    • “When he got back to the Capitol, Schumer told reporters that he made clear to Speaker Mike Johnson, R-La., that avoiding a shutdown would require another continuing resolution. Senate Minority Leader Mitch McConnell, R-Ky., also told reporters at the Capitol that leaders seemed to agree at the White House on the need to avert a shutdown.”
  • The Wall Street Journal relates,
    • “The Justice Department has launched an antitrust investigation into UnitedHealth, owner of the biggest U.S. health insurer, a leading manager of drug benefits and a sprawling network of doctor groups.
    • “The investigators have in recent weeks been interviewing healthcare-industry representatives in sectors where UnitedHealth competes, including doctor groups, according to people with knowledge of the meetings.
    • “During their interviews, investigators have asked about issues including certain relationships between the company’s UnitedHealthcare insurance unit and its Optum health-services arm, which owns physician groups, among other assets. 
    • “Investigators have asked about the possible effects of the company’s doctor-group acquisitions on rivals and consumers, the people said.
    • “Spokespeople for UnitedHealth and the Justice Department declined to comment. UnitedHealth executives have said Optum and UnitedHealthcare don’t favor one another, and routinely work with competitors.” 
  • According to Healthcare Dive,
    • “Proposed Medicare Advantage rates for 2025 could have a steeper impact on health plans’ payment than the government expects, according to a new study funded by a payer lobbying group.
    • “The analysis — backed by the Better Medicare Alliance, which represents payers in the private Medicare program — found MA payment per month per beneficiary could drop by 1% next year if the CMS finalizes the changes. In comparison, the CMS expects payments to MA plans to drop 0.16% under its proposal.
    • Study authors warned that when government reimbursement drops, MA benefits for seniors like supplemental benefits and lower premiums and cost-sharing also tend to be reduced. Health insurers have made similar arguments in recent earnings calls lobbying against the rate changes, which could reduce profitability of their MA businesses.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Administration for Community Living (ACL), announced several new initiatives and resources from ACL’s Direct Care Workforce (DCW) Strategies Center to address the dire shortage of professionals who provide the services many older adults and people with disabilities need to live in the community. These include two technical assistance opportunities to help states strengthen their systems for recruiting, retaining, and developing direct care workers; a national hub to connect states, stakeholders and communities to best practices and other resources related to the direct care workforce; and a webinar series for states and stakeholders focused on a range of direct care workforce topics. These initiatives will help sustain the impact of the $37 billion in American Rescue Plan funding invested to date by states in home and community-based services, and support the comprehensive set of actions and investments included in the President’s executive order to improve care.”
  • Per an OPM press release,
    • “The U.S. Office of Personnel Management (OPM) and the Office of Management and Budget (OMB) released the first-ever government-wide Military-Connected Strategic Plan for FY 2024-2028 to support agencies in their efforts to recruit, hire, and retain military-connected spouses, caregivers, and survivors within the federal government. 
    • “Advancing economic opportunity for military-connected spouses, caregivers, and survivors strengthens our federal workforce and the nation,” said OPM Director Kiran Ahuja. “A good-paying, flexible, and dependable federal job strengthens the economic security of our military families and helps spouses succeed in their own careers, while also supporting their loved ones in uniform. Tackling barriers to recruiting, hiring, and retaining talent also improves our workforce and expands our talent pool to mission-driven public servants who want to give back to their country.” 
  • Federal News Network informs us,
    • “As agencies ramp up recruitment of federal AI professionals, the Office of Personnel Management is highlighting existing workplace flexibilities that can ease the process.
    • “Incentives such as pay bonuses, faster leave accrual, student loan repayments, and telework and remote work can all help agencies more effectively hire AI specialists, OPM said in new federal AI hiring guidance, published Tuesday.
    • “Agencies can extend most — but not all — of the workplace flexibilities to incoming federal AI experts without first needing to get approval from OPM.
    • “For the few flexibilities that require OPM approval — special rates, critical pay and waivers of the recruitment, relocation and retention incentive payment limits — we stand ready to assist agencies and respond to their requests for enhanced compensation tools,” OPM Director Kiran Ahuja said in the guidance.”
  • Beckers Hospital Review adds,
    • “On Feb. 23, Colorado secured a national first by agreeing to establish a price ceiling on a medication, The Denver Post reported. 
    • “The state’s Prescription Drug Affordability Board voted in favor of capping the cost of arthritis drug Enbrel, which has a list price of $1,850.46 for a weekly dose. Colorado legislators createdthe five-member board in 2021 to sniff out medications deemed “unaffordable” and establish a payment limit for state-regulated commercial payers.
    • “By late August, the board will either narrow down an appropriate cost for Enbrel or vote against setting a price ceiling, according to The Denver Post. If established, the price cap would limit how much pharmacies could pay for the drug, and patients and payers would then pay that amount and a fee to cover the pharmacy’s handling costs.” 

From the public health and medical research front,

  • The Food and Drug Administration announced yesterday,
    • “[O]n May 16, 2024, the FDA’s Vaccines and Related Biological Products Advisory Committee will meet to publicly discuss and make recommendations on the selection of strain(s) to be included in the 2024-2025 formula for COVID-19 vaccines.  
    • “The FDA anticipates that changes to the vaccine composition may need to be made based on the currently circulating strains of the virus that causes COVID-19. As the agency has previously stated, barring any new major changes to circulating virus, the FDA expects that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.
    • “Following any potential recommendations to update the 2024-2025 formula, the FDA anticipates that, subject to appropriate regulatory actions, manufacturers will be able to make updated COVID-19 vaccines available in advance of the fall/winter respiratory virus season.”
  • The National Institutes of Health announced today,
    • “People with type 2 diabetes who underwent bariatric surgery achieved better long-term blood glucose control compared to people who received medical management plus lifestyle interventions, according to a new study supported by the National Institutes of Health. The participants who underwent bariatric surgery, also called metabolic or weight-loss surgery, were also more likely to stop needing diabetes medications and had higher rates of diabetes remission up to 12 years post-surgery. Results of the study were published in JAMA(link is external) and funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of NIH.
    • “While there are many factors involved, and not all of them are completely understood, bariatric surgery typically results in greater weight loss that affects a person’s metabolic hormones, which improves the body’s response to insulin and ability to maintain healthy blood glucose levels,” said Dr. Jean Lawrence, NIDDK project scientist. “These results show that people with overweight or obesity and type 2 diabetes can make long-term improvements in their health and change the trajectory of their diabetes through surgery.”
    • “The current study is a follow-up that combined data from four independent single-center randomized trials conducted at clinical sites in the United States. The original trials, which were conducted between May 2007 and August 2013, evaluated the effectiveness of bariatric surgery compared to intensive lifestyle and medication therapy involving oral and injectable diabetes medications including insulin, for adults with type 2 diabetes and overweight or obesity. While some participants in the study were prescribed GLP-1 agonists as part of their medical management of diabetes, these drugs were not specifically examined in the study. The investigators from the four individual studies pooled their data to provide a larger and more geographically diverse data set to evaluate efficacy, durability, and safety of bariatric surgery to treat type 2 diabetes. Follow-up data were collected through July 2022.”
  • The U.S. Preventive Services Task Force preliminarily recommended an inconclusive grade for Screening and Supplementation of Iron Deficiency and Iron Deficiency Anemia During Pregnancy. The public comment period is open until March 25, 2024.
  • The Centers for Disease Control offers important guidance on diabetes and feet.
    • “About half of all people with diabetes have some kind of nerve damage. You can have nerve damage in any part of your body, but nerves in your feet and legs are most often affected. Nerve damage can cause you to lose feeling in your feet.”
  • BioPharma Dive lets us know,
    • “An experimental weight loss drug developed by Viking Therapeutics helped overweight and obese people lose up to 15% of their body weight after 13 weeks of treatment in a mid-stage trial, the company said Tuesday.
    • “The drug, a potential rival to Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy, led to greater weight loss over that time period than both of those medicines did in clinical testing. However, Wall Street analysts cautioned the effects of Viking’s therapy need to be confirmed in a larger Phase 3 trial.”

From the U.S. public health front,

  • Beckers Hospital Review points out,
    • “UnitedHealth Group estimates 90% of the 70,000-plus pharmacies in the U.S. using Change Healthcare’s platform have modified electronic claims processing to mitigate effects of the cybersecurity incident that hit the company last week.
    • “The remaining 10% have offline processing workarounds, according to a Feb. 26 statement from UnitedHealth Group, which owns Change Healthcare. The cybersecurity issue, believed to be the work of a foreign nation-state-associated cybersecurity threat actor, caused enterprisewide connectivity issues.
    • “UnitedHealth Group reported Optum Rx and UnitedHealthcare have seen few reports of issues, and fewer than 100 out of the 65 million pharmacy benefit manager members have not been able to get their prescriptions. The company has immediately escalated patients that haven’t been able to access prescriptions to preserve continuity of care.
    • “Since identifying the issue on Feb. 21, Change has worked closely with customers and clients to secure access to medications during the network disruption. The company is also working with law enforcement, Mandiant, Palo Alto Networks, and other third parties to investigate and resolve the issues.
    • “We appreciate the partnership and hard work of all of our relevant stakeholders to ensure providers and pharmacists have effective workarounds to serve their patients as systems are restored to normal,” said the statement. “As we remediate, the most impacted partners are those who have disconnected from our systems and/or have not chosen to execute workarounds.”
    • “The company also noted hospitals and health systems have connections with multiple clearinghouses and manual workarounds to continue providing care.”
  • Per Fierce Healthcare,
    • “Signify Health is expanding its in-home diagnostics offering to include a test for heart arrhythmias.
    • “The CVS Health subsidiary said Tuesday that the prevalence of irregular heartbeats is set to grow alongside an aging population. Atrial fibrillation, the most common type of arrhythmia, can be asymptomatic, and there are likely between 1.26 million and 1.52 million undiagnosed cases.
    • “Patients with a heart arrhythmia who are undiagnosed may face symptoms like shortness of breath, chest pain and rapid or irregular heartbeat, and face potential stroke or diabetes.
    • “Through the program, Signify members who are at risk for an arrhythmia are identified, and then its clinical teams will test for contraindications. Members will asked to wear a continuous ECG patch, which tracks continuous cardiac activity, and, after 14 days, the team will review the results for signs of irregular heartbeat.”
  • and
    • “Highmark is teaming up with Epic and Google Cloud to improve the flow of data between payers and providers to enhance care coordination and drive better outcomes.
    • “The goal, the insurer said, is to arm providers with the most valuable data at the point of care, enabling them to improve patient outcomes and close critical care gaps.
    • “We really need better ways to get the right information in front of the clinicians at the right time,” Richard Clarke, Ph.D., senior vice president and chief analytics officer for Highmark Health, told Fierce Healthcare. 
    • “Epic’s Payer Platform allows for “bidirectional” data sharing between the payer and the provider, he said, and Google Cloud’s technology makes it flexible enough to connect with Highmark’s existing systems readily.”
  • Fortune Well writes about a woman whose recently deceased mother’s estate is saddled with an $81,000 air ambulance bill because her mother declined Medicare Part B coverage.
    • “People who are eligible for Medicare are encouraged to sign up for Part B, unless they have private health insurance through an employer or spouse.
    • “If someone with Medicare finds that they are having difficulty paying the Medicare Part B premiums, there are resources available to help compare Medicare coverage choices and learn about options to help pay for Medicare costs,” Meena Seshamani, director of the federal Center for Medicare, said in an email to KFF Health News.
    • “She noted that every state offers free counseling to help people navigate Medicare.”

Happy Presidents’ Day

From Washington, DC

From the public health and medical research front,

  • ABC News reports,
    • “Half of all states are seeing high levels of respiratory virus activity, new federal data updated Friday shows.
    • “Currently, 25 states plus New York City and Washington, D.C., are experiencing “high” or “very high” levels of respiratory illness activity, according to the Centers for Disease Control and Prevention (CDC).
    • “While this is higher than the 23 states experiencing “high” or “very high” activity levels last week, it is fewer than the peak of 38 states reporting “high’ or ‘very high’ levels the week ending Dec. 30. * * *
    • “Adults over age 65 continue to have the highest rates of both COVID and flu hospitalizations.”
  • Fortune Well informs us,
    • “Vaccines that protect against severe illness, death and lingering long Covid symptoms from a coronavirus infection were linked to small increases in neurological, blood, and heart-related conditions in the largest global vaccine safety study to date.
    • “The rare events — identified early in the pandemic — included a higher risk of heart-related inflammation from mRNA shots made by Pfizer Inc., BioNTechSE, and Moderna Inc., and an increased risk of a type of blood clot in the brain after immunization with viral-vector vaccines such as the one developed by the University of Oxford and made by AstraZeneca Plc. 
    • “The viral-vector jabs were also tied to an increased risk of Guillain-Barre syndrome, a neurological disorder in which the immune system mistakenly attacks the peripheral nervous system.”
  • and
    • “They say anything men can do, women can do better—which may include reaping the health benefits of regular exercise. That’s according to a new study published today in the Journal of the American College of Cardiology.
    • “An international team of researchers from the U.S. and China showed that women who exercise regularly have a significantly lower risk of an early death or a fatal cardiovascular event than men who do the same. On top of that, the advantage holds true even when women put in less effort.
    • “The observational study, which analyzed the exercise habits of more than 400,000 U.S. adults, found that compared to being inactive, engaging in regular physical activity lowered women’s mortality risk by 24%. Men saw a 15% reduction in risk.
    • “Women who worked out also had a 36% reduced risk of a fatal cardiovascular event, such as a stroke or heart attack, than their inactive peers. Among men, those who were physically active showed a 14% reduced risk.”
  • The Washington Post reports,
    • “About 1 in 4 U.S. adults 65 and older — more than 14 million people — suffer a fall each year, according to the Centers for Disease Control and Prevention.
    • “Falls are the leading cause of injury among those 65 and older, even though not all falls result in an injury, the CDC says. About 37 percent of older people who have fallen have sustained an injury that required medical treatment or activity restrictions. For instance, the CDC reports that 95 percent of hip fractures result from a fall, and falls also are the most common cause of traumatic brain injuries.
    • “The National Institute on Aging notes that the odds of falling increase with age, but falls often can be prevented. Standard suggestions include fall-proofing your home space (making sure all stairs have hand rails and are well-lit, eliminating most throw rugs and keeping walk spaces clutter-free), careful management of medications (especially those that can cause dizziness or confusion), having regular vision checks and staying as active as possible (including doing exercises to maintain strength and balance).”
  • STAT News tells us,
    • “Niacin, or vitamin B3, has long been a U.S. public health darling to the point that it is added, by law, to cereal products. But a new study published Monday in Nature Medicine points to a potentially concerning effect of an excess of the vitamin: It may increase the risk of cardiovascular disease.
    • “The study looked into two cohorts of patients without active heart disease, 60% of whom were treated with statins, and found a strong association between a metabolic product of excess niacin and an increased risk of major adverse cardiovascular events such as a heart attack or stroke. One in four of the people in the study had excess niacin, which doubled their risk of major cardiovascular events to levels comparable with diabetes or a previous heart attack.
    • “It’s a fairly sizable risk. It’s on par with what we consider other large risks,” said Stanley Hazen, the section head of preventive cardiology and cardiac rehabilitation at the Cleveland Clinic and senior author of the study. “This opens up the door; it lays the foundation for new studies and new interventions from both a diagnostic and therapeutic perspective to try to reduce inflammation and cardiovascular disease.”
  • Per Medscape,
    • “A plant-based diet, low in dairy and meat but rich in fruits, vegetables, grains, and nuts, can improve sexual and urinary health in patients treated for local prostate cancer, new research showed.
    • “The findings, published on February 13, 2024, in the journal Cancer, bolster previous research showing plant-based diets can reduce the risk for recurrence and improve survivorship in men with prostate cancer.
    • “The current study shows for the first time an association between eating more plant-based food with better scores for quality of life among patients diagnosed with prostate cancer,” Stacy Loeb, MD, a urologist in the Departments of Urology and Population Health at NYU Langone Health, in New York City, who led the research.”
  • and
    • Cefepime-taniborbactam was 22% more effective than meropenem, which is a current treatment for complicated urinary tract infections (UTIs) and acute pyelonephritis, according to a study published in The New England Journal of Medicine.

From the healthcare business front,

  • The Wall Street Journal reports,
    • “China has more obese people than anywhere else in the world, and they are increasingly turning to weight-loss drugs to solve the problem.
    • “That is fueling a gray market of drug sellers and buyers, who have little trouble getting around China’s rules on the use of Ozempic. 
    • “Ozempic isn’t available for weight loss in the country, instead being reserved for the treatment of Type 2 diabetes. But users on e-commerce platforms are able to buy the shots, colloquially known as “miracle drugs,” simply by declaring they have been diagnosed with diabetes—without providing proof. 
    • “They aren’t getting a bad deal: On JD.com, a dosage of Ozempic retails for around $139. That is higher than its cost on the country’s national-insurance plan but much cheaper than the $970 some users pay in the U.S. each month. JD.com didn’t respond to requests for comment.”
  • NPR Shots notes,
    • “Bayer is the latest name-brand drugmaker to dip its toe into the world of Mark Cuban’s online pharmacy, Cost Plus Drugs. 
    • “The website offers drugs at steep discounts bypassing middlemen called pharmacy benefit managersIt mostly sells generics, but has been slowly adding brand name products as well. 
    • “Yaz birth control pills and Climara, a hormone patch for menopause, will both now be available for a fraction of their list prices, including Cost Plus’s standard 15% markup and shipping.
    • “As I look at our partnership with Cost Plus, I really look at this as a test and learn,” says Sebastian Guth, president of U.S. Pharmaceuticals at Bayer. “It’s a first initial step. We will learn and see what the results of this partnership are and may then decide to expand it further.”
  • Beckers Payer Issues points out,
    • “Some health systems are getting out of the insurance business. 
    • “In the first weeks of 2024, two health systems announced plans to sell their health insurance subsidiaries. In February, Springfield, Mass.-based Baystate Health reached a deal to sell Health New England to Point32Health. 
    • “In January, Toledo, Ohio-based ProMedica said it planned to sell its insurance subsidiary, Paramount Health, to Medical Mutual of Ohio. 
    • “Baystate Health has around 180,000 members in Medicare, Medicaid and commercial, and Paramount Health has more than 77,000 members in Medicare Advantage, commercial, individual and short-term plans. Both are set to be acquired by larger nonprofit insurers. Point32Health and Medical Mutual of Ohio each have over 1 million members.” 

Friday Factoids

Photo by Sincerely Media on Unsplash

From Washington, DC

  • The Federal Times reports,
    • “It took 13 years — with some stops, starts and stumbles in between — but as of today, the federal government now has a single website designed to deliver detailed, searchable information about all federal programs.
    • “The Office of Management and Budget flipped the switch Thursday on the new Federal Program Inventory, a platform it’s been building via various pilot efforts since December 2020. Officials acknowledge it doesn’t yet capture every single program: For now, only “domestic assistance” programs are included. But that broad category encompasses most federal spending, ranging from Social Security and Medicare to the smallest community block grant programs.
    • “As of now, the database includes spending and performance data on 2,388 programs, said Diedre Harrison, OMB’s deputy controller.”
  • The FEHBlog cannot locate the FEHBP in this database, FYI. What’s more,
    • “The Treasury Department and the IRS are calling on teleworking employees to return to the office for half of their workdays, starting in a few months.
    • “IRS Commissioner Danny Werfel told employees in an email Thursday that teleworking employees will need to return to the office 50% of the time, on any given month, starting on May 5.
    • “Our top priority, regardless of where employees are located at any point in time, will continue to be meeting our goals of serving taxpayers, ensuring tax compliance and maintaining our vital technology and operations,” Werfel wrote.
    • “The return-to-office plans will only impact IRS executives, managers and non-bargaining unit employees with telework agreements in the National Capital Region. The decision affects IRS headquarters, the agency’s New Carrollton Federal Building and other offices in the Washington, D.C. area.”
  • Healthcare Dive points out,
    • “The federal government received 13 times more surprise billing disputes in the first half of 2023 than it expected to receive in a full year, according to new CMS data.
    • “And the amount is growing each quarter, contributing to a growing backlog and straining the capacity of the system regulators set up to arbitrate disputes over medical bills between providers and health insurers.
    • “Of the 288,810 disputes filed in the first six months of 2023, fewer than half were closed, and arbiters rendered payment decisions in under a third of cases. Of those, providers won 77% of payment determinations, while health plans prevailed in 23% — noteworthy statistics given providers have argued the arbitration process is unfairly weighted toward insurers.”
  • The Commonwealth Fund discusses the status of creating a separate version of the No Surprises Act for ground ambulances.
  • Newfront fills us in on federal claim substantiation rules for flexible spending accounts, health reimbursement accounts, and health savings accounts.
  • The Wall Street Journal reports,
    • “Novartis and Roche Holding said the U.S. Food and Drug Administration approved their Xolair treatment to reduce allergic reactions following the exposure to one or more foods.
    • “The pharmaceutical companies on Friday said Xolair has been approved for patients aged one year and older with the IgE-mediated food allergy.
    • “Patients taking Xolair for food allergies should continue to avoid all foods they are allergic to, the companies added.
    • “Xolair, a prescription biologic medicine that is given as an injection, shouldn’t be taken as an emergency treatment for allergic reactions.”
  • BioPharma Dive adds,
    • “The Food and Drug Administration will decide by June 21 whether to loosen the restrictions surrounding use of Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy, the company said Friday
    • “Sarepta’s gene therapy, Elevidys, was granted a conditional OK last June for children between 4 and 5 years of age who have Duchenne and can still walk. Sarepta aims to convert that nod to a full approval for all people with Duchenne and a confirmed mutation to a specific gene, even though Elevidys failed to hit its main goal in a study meant to confirm its benefits. 
    • “Sarepta, for its part, has argued that the collective evidence it’s accrued proves Elevidys is impacting the disease. Analysts appear optimistic of its chances, given the agency won’t convene a group of outside experts to review its request.”  

From the public health and medical research front,

  • The Centers for Disease Control tells us
    • In September 2023, CDC’s Advisory Committee on Immunization Practices recommended updated 2023–2024 (monovalent XBB.1.5) COVID-19 vaccination for all persons aged ≥6 months to prevent COVID-19, including severe disease. Many variants co-circulated during fall 2023; the JN.1 lineage became predominant in January 2024. Few estimates of updated 2023–2024 vaccine effectiveness (VE) are available.
    • What is added by this report?
    • Receipt of updated COVID-19 vaccine provided approximately 54% increased protection against symptomatic SARS-CoV-2 infection compared with no receipt of updated vaccine. Vaccination provides protection against JN.1 and other circulating lineages.
    • What are the implications for public health practice?
    • All persons aged ≥6 months should receive updated 2023–2024 COVID-19 vaccine. CDC will continue monitoring COVID-19 VE, including against severe disease and for expected waning.
  • The CDC called attention to its website on RSV prevention.
  • MedCity News offers
    • “Three Tips To Improve Health Plans’ Chronic Conditions Management 
    • “During a virtual panel, leaders from across the industry shared their advice on how health plans can do a better job of achieving their goals for chronic management. For example, one executive said health plans should utilize remote monitoring tools for centralized observation and be wary of using the wrong metrics.” 
  • Benefits Pro lets us know,
    • “Older Americans may forego elective surgeries because they are worried about out-of-pocket expenses and time away from work, along with potential exposure to COVID-19.
    • “This is according to a study by the University of Michigan Institute for Healthcare Policy and Innovation, which discovered that these factors tend to dissuade older Americans from going through with surgeries more than concerns about pain or the recovery process.
    • “Nearly half of those who said they were very concerned about cost and more than half of those who were very concerned about taking time off of work ended up not having a surgery they were considering, the study found. However, those who were concerned about surgery-related pain were just as likely as those with no concerns about pain to go ahead with surgery.”
  • Medscape calls attention to “How the New MRSA Antibiotic Cracked AI’s ‘Black Box.'”
    • “The MIT study is part of the Antibiotics-AI project, a 7-year effort to leverage AI to find new antibiotics. Phare Bio, a nonprofit started by MIT professor James Collins, PhD, and others, will do clinical testing on the antibiotic candidates.
    • “Even with the AI’s assistance, there’s still a long way to go before clinical approval.
    • “But knowing which elements contribute to a candidate’s effectiveness against MRSA could help the researchers formulate scientific hypotheses and design better validation, Lee noted. In other words, because they used explainable AI, they could be better positioned for clinical trial success.”
  • The New York Times reports,
    • “Growing numbers of children and adolescents are being prescribed multiple psychiatric drugs to take simultaneously, according to a new study by researchers at the University of Maryland. The phenomenon is increasing despite warnings that psychotropic drug combinations in young people have not been tested for safety or studied for their impact on the developing brain.
    • “The study, published Friday in JAMA Open Network, looked at the prescribing patterns among patients 17 or younger enrolled in Medicaid from 2015 to 2020 in a single U.S. state that the researchers declined to name. In this group, there was a 9.5 percent increase in the prevalence of “polypharmacy,” which the study defined as taking three or more different classes of psychiatric medications, including antidepressants, mood-stabilizing anticonvulsants, sedatives and drugs for A.D.H.D. and anxiety drugs.”
  • AP reports,
    • “Smoking has surpassed injecting as the most common way of taking drugs in U.S. overdose deaths, a new government study suggests.
    • “The Centers for Disease Control and Prevention called its study published Thursday the largest to look at how Americans took the drugs that killed them.
    • “CDC officials decided to study the topic after seeing reports from California suggesting that smoking fentanyl was becoming more common than injecting it. Potent, illicit versions of the painkiller are involved in more U.S. overdose deaths than any other drug.”

From the U.S. healthcare business front,

  • Healthcare Dive informs us,
    • “CommonSpirit Health cut its operating losses in the three months ended Dec. 31by working with payers to speed the rate of reimbursement for services and implementing cost containment measures, according to earnings released on Thursday.
    • “The Chicago-based health system reported an operating income of $356 million for the quarter. Normalized for the California provider fee program, CommonSpirit logged an operating loss of $87 million. In the same period last year, CommonSpirit reported an operating loss of $440 million.
    • “CommonSpirit said supply and salary inflation continues to vex the system. Salaries and benefit expenses increased $413 million, or 9.3%, year over year, primarily due to higher salary costs.”
  • RevCycle Intelligence adds,
    • “Rural healthcare’s outlook just worsened, according to a new analysis from Chartis, a healthcare advisory firm.
    • “The updated analysis of key indicators such as rural hospital operating margin, facility closures, and loss of access to care and services paints a grim picture for rural hospitals in the US, particularly independent providers.
    • “Half of rural hospitals are operating in the red, the analysis found, and that percentage increased from 43 percent a year ago. More independent rural hospitals are operating at a loss at 55 percent, while 42 percent of health system-affiliated rural hospitals have a deficit. The analysis noted that almost 60 percent of rural hospitals in the US are now affiliated with a health system.
    • “With more rural hospitals facing revenue losses, 418 facilities are “vulnerable to closure,” the analysis showed.
    • “America’s rural hospitals have been battling against drivers of instability for more than a decade, but this newest research suggests this crisis has accelerated quickly to previously unseen levels,” Michael Topchik, national leader of The Chartis Center for Rural Health, said in a statement. “To learn the percentage of rural hospitals in the red has shifted 7 [percent] and now includes half of all rural hospitals is startling and should serve as an urgent call to action for everyone invested in rural healthcare.”
  • Per Fierce Healthcare,
    • “Nearly all healthcare executives believe new digital health technologies are worth the cost, even though they have yet to see a financial return from it, a new survey reveals.
    • “The inaugural Health Pulse Survey was conducted by Ernst & Young and reached more than 100 payer and provider administrative executives across the U.S. It found that the appetite for digital health solutions has risen, particularly since COVID-19. The pandemic was a catalyst for the industry.
    • “COVID prompted a lot of digital health tech investments by payers and providers—it was out of necessity,” Kaushik Bhaumik, EY’s U.S. health technology leader, told Fierce Healthcare. “People had to connect with their patients through digital channels.” 
  • Reuters reports,
    • “A small but rapidly growing number of U.S. adolescents began treatment with Novo Nordisk’s weight-loss drug Wegovy last year, a powerful new tool to address record rates of pediatric obesity, according to data shared exclusively with Reuters.
    • “In the first 10 months of 2023, 1,268 children ages 12 to 17 with an obesity diagnosis started taking Wegovy, according to U.S. insurance claims data compiled by health technology company Komodo Health.”

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington, DC

  • STAT News reports
    • “The Biden administration is making its opening offers to pharmaceutical companies in its brand-new Medicare drug price negotiation program on Thursday, administration officials said. And that’s about all they said.
    • “The offers will not be made public unless a manufacturer chooses to publicly disclose information about the talks, a senior administration official said. Companies have until March 2 to either accept the government’s offer or propose a counteroffer. The Biden administration will publish the final prices by Sept. 1 of this year after the negotiation process ends. 
    • “The negotiated prices won’t take effect until 2026. 
    • “The first 10 drugs up for negotiation are Bristol Myers Squibb’s blood thinner Eliquis, Boehringer Ingelheim and Eli Lilly’s diabetes drug Jardiance, Johnson & Johnson’s blood thinner Xarelto, Merck’s diabetes drug Januvia, AstraZeneca’s diabetes drug Farxiga, Novartis’ heart failure treatment Entresto, Amgen’s rheumatoid arthritis drug Enbrel, Johnson & Johnson and AbbVie’s blood cancer treatment Imbruvica, J&J’s anti-inflammatory medicine Stelara, and Novo Nordisk insulins that go by names including Fiasp and NovoLog.”
  • Here is a link to PhRMA’s views on the development.
    • “The bottom line: This process is a black box that allows a few government bureaucrats to make politicized decisions about the value of medicines and with no accountability to patients or the public.”
  • BioSpace adds,
    • “A federal court in Delaware heard arguments Wednesday in a key lawsuit challenging Medicare drug-negotiation provisions of the Inflation Reduction Act (IRA). Reportsfrom inside the courtroom suggested that the judge was skeptical of the arguments raised by plaintiff AstraZeneca, though experts told BioSpace this is just an early step in what could be a protracted series of legal battles.
    • “While no ruling on AstraZeneca’s motion for summary judgment is expected for about a month, court activity will heat up over the next few weeks, as a total of 10 cases from pharma companies and groups have challenged various aspects of the IRA’s Medicare drug-pricing provisions. Other plaintiffs include MerckNovartisJohnson & JohnsonBristol Myers SquibbBoehringer Ingelheim, Novo Nordisk and the lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA).

From the public health and medical research front,

  • MedPage reports,
    • “The updated 2023-2024 COVID-19 vaccine was approximately 54% effective against symptomatic SARS-CoV-2 infection in adults, and was also effective against the JN.1 variant, which became predominant in January, CDC researchers said.
    • “Overall, vaccine effectiveness against symptomatic COVID was 57% for people ages 18 to 49 years and 46% for people ages 50 and older, reported Ruth Link-Gelles, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, and colleagues in the Morbidity and Mortality Weekly Report.”
  • and
    • “Military personnel stationed at Camp Lejeune from 1975 to 1985 had at least a 20% higher risk for a number of cancers than those stationed elsewhere, federal health officials said Wednesdayin a long-awaited study about the North Carolina base’s contaminated drinking water.
    • “Federal health officials called the research one the largest ever done in the U.S. to assess cancer risk by comparing a group who live and worked in a polluted environment to a similar group that did not.”
  • American Hospital Association News tells us,
    • “The Substance Abuse and Mental Health Services Administration Jan. 31 updated it Overdose Prevention and Response Toolkit, which includes basic information on overdose prevention and treatment as well as specific guidance and resources for health care providers and prescribers.”
  • The Institute for Clinical and Economic Review released
    • “its revised Evidence Report assessing the comparative clinical effectiveness and value of iptacopan (Novartis) and danicopan (Alexion Pharmaceuticals) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). While important health benefits for patients were shown in clinical trials for both agents, there is uncertainty about long-term efficacy and safety. ICER’s model for iptacopan, which is already FDA-approved, using a shared-savings approach (described in more detail below), suggests that the drug would need to be priced 70% lower than the current list price to meet commonly accepted thresholds. For danicopan, which is not yet FDA-approved, ICER’s model suggests the price would need to be between $12,300 and $13,100 per year to achieve common thresholds for cost-effectiveness.
    • “This Evidence Report will be reviewed at a virtual public meeting of the California Technology Assessment Forum (CTAF) on February 16, 2024.”
  • NPR discusses aging.
    • I used to flinch at the topic of aging. Is there anything we can do about the inevitable?
    • But recently I’ve been digging into a new wave of longevity research that is making it an exciting time to be an aging human — which is all of us.
    • It turns out, we all age at varying rates. Super-agers may have great genes, but research shows our habits and routines — everything from what we eat and how we move our bodies to who we spend our time with — matter a lot, when it comes to aging well.
    • Now, the next frontier is to target the basic biology of aging and come up with new interventions to slow it down.
    • Many scientists are optimistic that we’re on the cusp of breakthroughs. Not only to help us live longer, but — more importantly — to extend the number of years we live with good health.
    • This is the goal of researchers at the Human Longevity Lab at the Northwestern University Feinberg School of Medicine. They’re recruiting study participants so they can test what kinds of interventions may slow the rate of aging.
  • The reporter describes participating in this study.
  • HealthDay informs us,
    • “Adolescent substance use is associated with psychiatric symptoms, including suicidal thoughts, according to a research letter published online Jan. 29 in JAMA Pediatrics.
    • “Brenden Tervo-Clemmens, Ph.D., from the University of Minnesota in Minneapolis, and colleagues examined associations between commonly used substances and psychiatric symptoms among adolescents in two samples: students from 36 Massachusetts high schools who completed the 2022 to 2023 Substance Use and Risk Factor (SURF) Survey and analogous self-reported items from the 2021 Youth Risk Behavior Survey (YRBS). Data were included for 15,626 SURF participants and 17,232 YRBS participants.
    • “The researchers found significant, moderate dose-dependent associations for alcohol, cannabis, and nicotine use with worse psychiatric symptoms, including suicidal thoughts in SURF and YRBS, depressive or anxiety symptoms and inattention or hyperactivity in SURF, and general mental health in YRBS.” 
  • Memory Care Business notes,
    • “A new global effort is underway to accelerate the prevention, diagnosis and management of Alzheimer’s and other forms of dementia. 
    • “The effort, dubbed the Alzheimer’s Moonshot, was announced by StartUp Health in partnership with the Alzheimer’s Drug Discovery Foundation’s Diagnostics accelerator and Gates Ventures, the private office of entrepreneur Bill Gates. 
    • “The Alzheimer’s effort is among a new series of “moonshots” from StartUp Health. The efforts also have taken aim at other health challenges, such as Type 1 diabetes, with the goal of bringing together like-minded company founders and researchers in those spaces.”
  • The Washington Post reports,
    • “An international team led by scientists at Stanford University has discovered a probable explanation for a decades-old biological mystery: why vastly more women than men suffer from autoimmune diseases such as lupus and rheumatoid arthritis.
    • “Women account for about 80 percent of the people afflicted with autoimmune diseases, a collection of more than 100 ailments that burden a combined 50 million Americans, according to the nonprofit Autoimmune Association. In simple terms, these illnesses manipulate the body’s immune system to attack healthy tissue.
    • “In a paper published Thursday in the journal Cell, researchers present new evidence that a molecule called Xist — pronounced like the word “exist” and found only in women — is a major culprit in these diseases.
    • “Better understanding of this molecule could lead to new tests that catch autoimmune diseases sooner and, in the longer term, to new and more effective treatments, researchers said.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Tenet Healthcare has disclosed a pair of new and completed hospital transactions alongside projections that next week’s 2023 financial report “will be above the high end” of its guidance.”
  • and
    • “New Jersey providers Saint Peter’s Healthcare System and Atlantic Health System have taken the first step toward a merger they said would include “significant investments” in the Catholic system’s service area.”
  • and
    • “Hospitals and health systems closed out the year on a high note with margins up more than 15% from 2022, according to Kaufman Hall.”
    • “The firm’s latest sector-wide monthly report pointed to an increase in year-to-date operating margin index, from 1.9% through November to 2.3% at the end of the year. On a single-month basis, the operating margin index rose from 3.2% to 4.6% at the same cutoffs.
    • “These improved margins indicate that hospitals and health systems are taking the necessary steps to adapt to this new environment,” Erik Swanson, senior vice president of data and analytics with Kaufman Hall, said in a release. “While finances are approaching historic levels, today’s care and business models look very different. Organizations have had to adjust how and where they’re delivering services to better meet patient preferences.”
  • Healthcare Dive lets us know,
    • “Healthcare executives prioritize data considerations when it comes to using generative artificial intelligence, which could prevent them from successfully integrating the hot button technology, according to a report by consultancy Deloitte. 
    • “While 82% of 60 respondents rated data availability, quality and reliability as a top consideration for implementing generative AI, only 45% cited mitigating biases or patient education on the technology and its risks as their greatest considerations when implementing the technology.
    • “Data is important, but the industry needs a “robust overarching framework” that focuses equally on governance, consumer needs and worker concerns, the report’s authors wrote.”
  • STAT News reports,
    • Merck reported earnings for the fourth-quarter and 2023. On 2024 guidance, Merck said it expects sales in the range of $62.7-$64.2 billion, or a 6% increase at the midpoint. Current Street consensus is $63.5 billion. Adjusted earnings are forecast to be between $8.44 and $8.59 per share.
    • More pharma earnings from Roche and Sanofi.
  • and
    • “Novavax, the company whose corporate missteps repeatedly sidelined an effective Covid-19 vaccine, is relying on demand for booster doses to remain solvent. And the latest update isn’t exactly encouraging.
    • “The company said yesterday that it would lay off another 12% of its staff, expanding on a cost-cutting plan disclosed last year. In the end, Novavax will have reduced its workforce by about 30% compared to 2023, part of an effort to reduce its expenses in the months to come.”
  • NewFront offers guidance on correcting mistaken health savings account distributions.


 

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington, DC

  • Govexec informs us,
    • “President Biden on Thursday issued an executive order implementing his plan to provide civilian federal workers with an average 5.2% pay raise next month.
    • “As first proposed in his fiscal 2024 budget plan last March, the increase amounts to a 4.7% across-the-board boost to basic pay, alongside an average 0.5% increase in locality pay. As authorized in the fiscal 2024 National Defense Authorization Act, which Biden is expected to sign this week, military service personnel also will see an average 5.2% pay raise next year.
    • “An average 5.2% pay increase marks the largest authorized for federal workers since the Carter administration adopted a 9.1% average raise in 1980, as well as a 0.6% increase over last year’s raise, which itself marked a 20-year high.”
  • STAT News reports
    • “Lawmakers are facing down a Jan. 19 deadline to renew a variety of expiring health care programs, so they just tucked away an extra $1.8 billion in a Medicare reserve fund in the NDAA, a Senate aide confirmed. They achieved the savings by extending the Medicare sequester’s end date, and then used some of the funds to pay for World Trade Center Health Program policies to support 9/11 survivors and first responders.
    • “The additional savings went to the Medicare piggy bank, formally known as the Medicare Improvement Fund, referred to in wonky circles as the MIF. Lawmakers will be able to pull from the MIF early next year as they weigh how to fund community health centers and stave off pay cuts to safety-net hospitals. It’s not a fortune, but it’s also nothing to sneeze at, given hospitals are panicked about the prospect of a payment policy passing that would save the federal government $3.7 billion over the next decade. It also gives them some wiggle room if they need to do another short-term extension of the programs.”
  • The American Hospital Association News relates,
    • “The Departments of Health and Human Services, Labor and Treasury Dec. 15 reopened the federal independent dispute resolution portal to process all dispute types. Given the significant backlog resulting from the suspension of operations, the agencies today further extended the deadlines to March 14, 2024, for any IDR deadlines that fell in the suspension timeframe of Aug. 3 through Dec. 14, 2023, or currently have an initiation deadline between Dec. 15, 2023, and March 13, 2024. CMS announced extensions for additional dispute processes, including additional response time for requests for information, extension requests for offer submissions, and additional time to select a certified IDR entity for disputes.”
  • A bipartisan group of Senators sent a letter to the ACA regulators telling them
    • “We are writing in support of the recent decision from the U.S. District Court for the District of Columbia that vacated the 2021 Notice of Benefit and Payment Parameters (NBPP) Final Rule provision that permitted the use of copay accumulator adjustment programs (AAPs) and remanded to the U.S. Department of Health and Human Services (HHS) to interpret the definition of “cost-sharing.” * * *
    • We are disappointed in HHS’s decision to file a notice of appeal of the decision and HHS’s articulated intention to not take any enforcement action against health insurance issuers or health plans that fail to count copay assistance toward the patient’s maximum annual limitation on cost-sharing. Instead of appealing the court’s ruling, we urge you to adopt policies from the 2020 NBPP that strike the right balance of preserving a plan’s ability to control costs while also putting the patient first.”
  • The 2020 NBPP permitted copay accumulators as long as State law did not object. “To date, 19 states, the District of Columbia, and Puerto Rico have banned or limited the use of copay accumulators.
  • Bloomberg reports,
    • “Some of the largest US hospital chains and most prestigious academic medical centers have violated federal rules by not posting the prices they charge for care, according to records obtained by Bloomberg News.
    • “For-profit HCA Healthcare Inc., the nation’s largest hospital system, and big nonprofit operators including Ascension and Trinity Health have been cited for failing to make prices fully available to the public, enforcement letters Bloomberg obtained through a public records request show. So have marquee facilities such as New York Presbyterian Weill Cornell Medical Center, Emory University Hospital and the Hospital of the University of Pennsylvania.
    • “The records reveal the challenges US regulators face as they try to force long-hidden prices into the open to address decades of rising medical expenses. Since 2021, hospitals have been required to be more transparent about what they charge. However, government data show that among 1,750 hospitals regulators evaluated as of early December, about 1,300 facilities — nearly 20% of the hospitals in the US — have been warned they violated rules. 
    • “Most corrected errors after they were pointed out, and officials charged with enforcing the rules say they’ve seen more hospitals complying. Regulators are also working to make the price data more useful.”
  • The U.S. Preventive Services Task Force released a final research plan for prostate cancer screening. Its most recent March 2018 recommendation fell below the A or B level grades required for no-cost coverage when provided in-network. The next stage will be a proposed 2024 recommendation.
    • “The Task Force keeps recommendations as current as possible by routinely updating existing recommendations and developing new recommendations. A multistep process is followed for each recommendation. The Task Force uses gold standard methods to review the evidence and is transparent at each step of the recommendation development process.”

From the public health and medical research front,

  • HR Dive relates,
    • “Physical health in the U.S. has worsened since the onset of the COVID-19 pandemic, a shift that could have detrimental effects on employers, according to Gallup survey results released Dec. 14. 
    • “Both obesity and diabetes are on the rise, Gallup found. The percentage of U.S. adults Gallup determined to have diabetes is 38.4%, up 6 percentage points from 2019 and a hair behind the record high 39.9% recorded last year. The number of respondents who said they have diabetes hit a new high of 13.6%, an increase of 1.1 points since 2019, per Gallup. 
    • “These health effects have practical implications for the U.S. economy. After controlling for factors such as age, income and education, workers with poor physical health — and poor wellbeing generally — suffer greatly enhanced levels of unplanned absenteeism and healthcare utilization (and associated costs) than do their counterparts,” Dan Witters, research director of the Gallup National Health and Well-Being Index, said.”
  • Per Medscape,
    • “A new frontier of brain-based therapies — from GLP-1 agonist drugs thought to act on reward and appetite centers to deep brain stimulation aimed at resetting neural circuits — has kindled hope among [obese] patients like Smith and the doctors who treat them. The treatments, and theories behind them, are not without controversy. They’re expensive, have side effects, and, critics contend, pull focus from diet and exercise. 
    • “But most agree that in the battle against obesity, one crucial organ has been overlooked.
    • “Obesity, in almost all circumstances, is most likely a disorder of the brain,” said Casey Halpern, MD, an associate professor of neurosurgery at the University of Pennsylvania. “What these individuals need is not simply more willpower, but the therapeutic equivalent of an electrician that can make right these connections inside their brain.”
  • The Wall Street Journal similarly reports,
    • “What if the best way to treat your chronic back pain is by retraining your brain?
    • “That’s the premise of a novel approach to chronic pain. Many people feel pain even after a physical injury has healed or when doctors can’t find a physical cause. The approach, called “pain reprocessing therapy,” tries to train the brain not to send false pain signals. Some early results are promising.
    • “In a study published last year in JAMA Psychiatry, 66% of a group of people who did the therapy for a month were pain-free or nearly pain-free up to a year later.
    • “The treatment is still largely in the research stages and typically not covered by insurance, but is being performed in a growing number of centers, including the VA Eastern Colorado Health Care System, which plans to start two clinical trials of the technique next year.” 
  • The American Hospital Association News reports,
    • “A CDC study released Dec. 21 found low COVID-19 and flu vaccination coverage for most adults, and low RSV vaccination coverage for adults aged 60 and older. Antiviral treatments are also being underused, and COVID-19 rebound can happen whether patients receive any, the study said. Among other findings, the report said that most nursing home residents have not received an updated COVID-19 vaccine or RSV vaccine for residents aged 60 and older using shared clinical decision-making.”
  • Unfortunately, Patient Engagement HIT points out,
    • “Few Providers Use [ICD-10] Z-Codes to Document Social Determinants of Health.
    • “Use of Z-codes to document social determinants of health is low, and there are differences in which patients get a Z-code documented, two unrelated studies showed.

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “The labor outlook is stabilizing for U.S. nonprofit hospitals as employment increases and healthcare job openings decline, according toa new report from Fitch Ratings
    • “Hospital and ambulatory healthcare services payrolls have risen for 22 and 34 consecutive months respectively, according to the credit ratings agency. Wage growth has remained “relatively flat” at 4%. 
    • “Though the statistics indicate the hot labor market is cooling, Fitch said recruitment is still“hyper-competitive.” Health systems may need to offer higher salaries and better benefits to attract talent and dissuade skilled labor from seeking early retirement, the report said.” 
  • BioPharma Dive notes
    • “As ALS research booms, one treatment center finds itself in the spotlight.
    • “Mass General’s Healey Center is at the forefront of ALS research and care.
    • “Still, the complexities of the disease and of drug development have brought hard-felt losses.”
  • Per Fierce Healthcare,
    • “Two of southern California’s largest pediatric providers are planning to come together in 2024.
    • “The parent companies of Children’s Hospital of Orange County (CHOC) and Rady Children’s Hospital-San Diego announced Wednesday an agreement to merge under the new banner of Rady Children’s Health.
    • “The arrangement, which is subject to regulatory review, stands to help the organizations improve patient outcomes, increase access to care, accelerate treatment research and bolster their clinical and nonclinical workforces, the children’s hospitals said in their joint reveal.”

Monday Roundup

Photo by Sven Read on Unsplash

From Washington, DC (note the FEHBlog is back in Texas after a productive week in DC)

  • The Society for Human Resource Management tells us,
    • “The National Labor Relations Board (NLRB) announced it will extend the effective date of its joint employer rule to Feb. 26, 2024, to facilitate resolution of legal challenges to the rule.
    • “The NLRB released the final rule on Oct. 26 with an implementation date of Dec. 26. The rule was published in the Federal Register on Oct. 27.
    • “U.S. Sen. Bill Cassidy, R-La., sent a letter informing the NLRB that it was out of compliance with the Congressional Review Act’s 60-day threshold rule, which mandates that the implementation of all major federal rules must be delayed 60 days from when they are received by Congress.
  • The Internal Revenue Service posted for public comment a draft version of the 2024 Employers’ Tax Guide to Fringe Benefits.

From the public health and medical research front,

  • The Associate Press reports,
    • “The U.S. flu season is underway, with at least seven states reporting high levels of illnesses and cases rising in other parts of the country, health officials say.
    • “The Centers for Disease Control and Prevention posted new flu data on Friday, showing very high activity last week in Louisiana, and high activity in Alabama, Florida, Georgia, Mississippi, New Mexico and South Carolina. It was also high in the District of Columbia and Puerto Rico, the U.S. territory where health officials declared an influenza epidemic earlier this month. * * *
    • “Traditionally, the winter flu season ramps up in December or January. But it took off in October last year, and is making a November entrance this year.”
  • STAT News offers its observations on this development.
    • “The early signals from influenza suggest the virus is settling back into the seasonal pattern it followed — to the degree the always mercurial bug follows any pattern — before the pandemic, said Alicia Budd, team lead for domestic flu surveillance at the Centers for Disease Control and Prevention. “All I can say is at this point we are at a pretty typical point in flu activity,” she told STAT.
    • “Overall, the signs to date appear to portend a winter more like what we knew before the arrival of Covid, said Megan Culler Freeman, an assistant professor of pediatrics specializing in infectious diseases at the University of Pittsburgh.
    • “Last year as early as August, children’s hospitals across the country were full to the gills … because there were so many children with respiratory distress,” Freeman said. “And I would say that this season is starting to feel a lot more normal. Only now, as we’re getting into November — even towards mid- to late- November — we’re starting to see more of our winter volume starting to begin. * * *
    • “The scientific consensus is still out about whether Covid will be a seasonal virus, transmitting primarily during cold-and-flu season. Many experts think it is heading that way, but hasn’t yet settled into that pattern.”
  • The American Medical Association explains what doctors wish their patients knew about diabetes 2. Check it out.
  • KFF informs us,
    • Research suggests that the Novavax [Covid] vaccine is about as safe and effective as the mRNA shots. Its main disadvantage is arriving late to the scene. Vaccine uptake has plummeted since the first shots became widely available in 2021. Nearly 70% of people got the primary vaccines, compared with fewer than 20% opting for the mRNA covid boosters released last year. Numbers have dwindled further: As of Oct. 17, only 5% of people in the United States had gotten the latest covid vaccines, according to the Department of Health and Human Services.
    • “Daniel Park, an epidemiologist at George Washington University, said low rates might improve if people who felt lousy after their last mRNA shots gave Novavax a try. It protects against severe illness, but researchers struggle to specify just how effective this and other vaccines are, at this point, because studies have gotten tricky to conduct: New coronavirus variants continuously emerge, and people have fluctuating levels of immunity from previous vaccines and infections.
    • “Still, a recent study in Italy suggests that Novavax is comparable to mRNA vaccines. It remained more than 50% effective at preventing symptomatic covid four months after vaccination. Some data suggests that mixing and matching different types of vaccines confers stronger protection — although other studies have found no benefit. 
    • “Given all this, Park held out for the Novavax vaccine on account of its potentially milder side effects. “Between a demanding full-time job and two young kids at home, I wanted to stay operational,” he said. His arm was sore, but he didn’t have the 24-hour malaise accompanying his last mRNA shot.”

From the U.S. healthcare business front,

  • MedCity News notes,
    • “Eli Lilly’s cardiometabolic drug portfolio is expanding with newly approved therapies. To meet demand for those therapies and additional products to come, the company is building a new $2.5 billion manufacturing site in Germany.
    • “Construction on the new plant is on track to begin next year. Lilly expects the site will start operations in 2027, becoming its sixth manufacturing site in Europe. The company said it has invested more than $11 billion in its global manufacturing capabilities in the past three years to support the production of medicines across its portfolio.
    • “Some of Lilly’s capital investments have been closer to the Indianapolis-based drugmaker’s home. Last year, the company committed more than $2 billion to two new facilities in Lebanon, Indiana for the manufacturing of existing products and future ones, the company said in its annual report. Lilly also invested more than $1 billion in a new facility in Concord, North Carolina, for the manufacturing of injectable products and devices. Earlier this year, Lilly pledged to spend an additional $450 million to expand capacity at a site in Research Triangle Park that also makes injectable products, including new blockbuster medicine Mounjaro.”
  • Healthcare Dive points out,
    • “AstraZeneca’s new health-tech business, Evinova, launched Monday, with several big-name partnerships already in place and a goal to “better meet the needs of healthcare professionals, regulators and patients.”
    • “Evinova’s main focus will be helping to optimize their clinical trials for biotechnology companies, pharmaceutical firms and CROs, or contract research organizations, in an effort to reduce the time and costs associated with developing new medicines.
    • “Two CROs, Parexel and Fortrea, have agreed to offer Evinova’s digital health solutions to their customers. Evinova is also collaborating with Accenture and Amazon Web Services to “accelerate industry adoption and sustain and expand the global reach of its digital products.”
  • Per Fierce Healthcare,
    • “The financial outlook for major health plans is stable in the face of notable potential headwinds heading into the end of the year, according to a new report from Moody’s Investors Service.
    • “The Moody’s analysis said earnings in the third quarter were on par with reports from the second quarter and that the industry’s stability is in line with expectations. However, the researchers said they were expecting payers to face different challenges as 2023 got underway.
    • “A notable trend that emerged in the second quarter was increased utilization in Medicare Advantage (MA), which peaked in the second quarter thanks to a boost in outpatient care. While the trend did stabilize in the third quarter, “it did not get better,” the Moody’s analysts wrote.
    • “Centene was the lone exception, and it reported a lower medical loss ratio for MA in the third quarter of 2023 compared to the prior-year quarter, according to the report.”
  • and
    • “As the industry continues to debate the promise and risks of artificial intelligence in healthcare, patients are bullish on the potential for generative AI to improve access and even lower healthcare costs.
    • “More than half (53%) of U.S. consumers believe generative AI could improve access issues and shorten wait times for medical care, according to a survey by Deloitte’s Center for Health Solutions. A little less than half of consumers (46%) say it has the potential to make healthcare more affordable.”

Friday Factoids

From Washington, DC,

  • The Washington Post reports,
    • President Biden on Friday named W. Kimryn Rathmell to be the next director of the National Cancer Institute, where the prominent researcher will help oversee several White House-backed initiatives intended to reduce cancer deaths and accelerate clinical breakthroughs.
    • Rathmell, an expert in kidney cancer, is the chair of medicine at Vanderbilt University Medical Center in Nashville. The Stanford University-trained physician and scientist has been a member of the National Cancer Institute’s board of scientific advisers since 2018, providing guidance to the institute’s leaders on its scientific research and operations. Rathmell’s new role as head of the cancer institute, which the White House said would begin in December, does not require Senate confirmation.
  • Federal News Network tells us,
    • “The Office of Personnel Management faces a tight deadline to set up a new health insurance marketplace for Postal Service employees and retirees to enroll in new plans, starting next year.
    • “Now OPM is addressing watchdog concerns about whether the IT infrastructure supporting this new USPS marketplace is following federal cybersecurity requirements.
    • “OPM’s Office of Inspector General, in a flash audit released Friday, raised concerns about the cybersecurity steps OPM took before launching the IT systems that will run the Postal Service Health Benefits (PSHB) Program.”
  • Govexec tells us,
    • The Office of Personnel Management this week proposed new regulations delegating its authority to waive the caps on recruitment and relocation incentive payments to federal employees and job candidates to the agencies themselves, a move the federal government’s HR agency says will ease administrative burdens and accelerate the hiring process. * * *
    • “Under the new process, each agency would be required to designate an official who would be tasked with reviewing and adjudicating waiver requests. Additionally, the new regulations would eliminate the minimum service period required to receive an incentive payment. Currently set at six months, OPM argued that removal of the minimum time period would allow short-term, yet still difficult to fill positions such as paid internships to become eligible for recruitment and relocation incentives.
    • “Retention incentive payments would not change under the regulatory proposal, as OPM reported that such changes would require the passage of legislation by Congress.”
  • The Government Accountability Office issued a report on the composition of the federal workforce.
    • “The federal government aims to hire and promote a workforce that reflects the diversity of the U.S. population.
    • “We looked at a decade of federal employment trends. For example, from 2011-2021 there were minor changes in the representation of historically disadvantaged racial groups—like Black or African American and Asians—in the federal workforce. But several of these groups made gains in senior executive service positions.
    • “The percentage of Hispanic federal workers also increased. But in FY 2021, Hispanic individuals made up 10% of the federal workforce, even though they represented 18% of the civilian labor force.”
  • Reuters reports,
    • “The U.S. Centers for Disease Control and Prevention said on Thursday it has expedited the release of more than 77,000 additional doses of Sanofi (SASY.PA) and AstraZeneca’s (AZN.L) respiratory syncytial virus (RSV) drug Beyfortus.
    • “The additional doses, which the CDC said will be distributed immediately to physicians and hospitals, will help improve the availability of the drug at a time when a surge in cases of the disease is outpacing supply.
    • “Beyfortus was approved earlier this year to prevent the disease in infants and toddlers.
    • “CDC said the agency, along with the U.S. Food and Drug Administration, will continue to be in close contact with the manufacturers to ensure availability of additional doses through the end of this year and early 2024 to meet the demand.”

In FEHB News, Federal News Network offers a lengthy and informative exchange with Kevin Moss from Consumer Checkbook.

From the public health and medical research front,

  • STAT News points out,
    • “Flu activity in many parts of the United States is starting to rise more rapidly, signaling that flu season is on the horizon, the Centers for Disease Control and Prevention reported Friday.
    • “With Americans set to travel for Thanksgiving gatherings next week, people who’ve been waiting to get a flu shot should think about acting now, Alicia Budd, the CDC’s team lead for domestic flu surveillance, told STAT.
    • “Really what we’re seeing is a more sharp increase in activity, week over week, and we know from experience when that happens often times we are entering into that period of even more increased activity,” Budd said. “It’s a great time for people to get vaccinated, if they’ve been holding off.”
  • ABC News states,
    • An estimated 36 million adults in the United States have received the updated COVID-19 vaccine as of Monday according to new data from the federal government.  Additionally, about 3.5 million children have also gotten the updated shot, according to the survey, which is a sample size of the U.S. population, from the Centers for Disease Control and Prevention. This is roughly equal to the number of Americans who had received the bivalent booster — which was targeted against different COVID variants — by this time last year.
  • The Wall Street Journal reports,
    • “The Food and Drug Administration said it is screening cinnamon shipments from several countries as part of its investigation of illnesses potentially linked to pouches of cinnamon-flavored applesauce.
    • “The federal agency said this week it believes the cinnamon used in these products could be the source of lead contamination. There have been 34 reports of lead-related illnesses potentially tied to the recalled products. 
    • “The FDA, which has been investigating the lead illnesses since October, said they are potentially linked to contaminated children’s fruit puree and applesauce pouches. WanaBana,  Weis Markets and Schnucks brands have recalled cinnamon-flavored fruit puree and applesauce pouches.”
  • CNN reports,
    • “The rate of premature birth in the United States remains high, especially in the southern region of the country, according to the infant and maternal health nonprofit March of Dimes.
    • “The group’s annual “report card” on US maternal and infant health, released Thursday, says that the nation’s preterm birth rate – the rate of babies born before 37 weeks gestation – was 10.4% in 2022, down only 1% from 2021’s rate, which was the highest in more than a decade.
    • “We went from 10.5% to 10.4%. It’s flat,” said Dr. Elizabeth Cherot, president and chief executive officer of March of Dimes. “A slight change is just not big enough in that direction.”
  • Per NBC News,
    • The rate of child and teen cancer deaths in the U.S. fell 24% from 2001 to 2021, according to a CDC report released Thursday. The report looked at death rates, for Black, Hispanic and non-Hispanic whit youths up to 19 years old. These groups comprised 92% of all youth cancer deaths in 2021, the report noted.
  • Per STAT News, while Wegovy and Zepbound ride high, interest in weight loss drugs that preserve muscle is surging.
    • [B]iotech startups are hoping to use those [earlier Johns Hopkins] findings to create what they believe will be better weight loss medications. In the last several months, multiple companies have disclosed they are testing drugs that preserve or grow muscle while reducing fat, as shown in the updated STAT Obesity Drug Tracker. They hope that their drugs, possibly when used in conjunction with existing obesity treatments, will result in healthier weight loss.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • Rochester, Minnesota-based Mayo Clinic reported increased year-over-year operating revenue and income in its third-quarter earnings, on higher outpatient visits and surgical cases.
    • The nonprofit posted $4.5 billion in operating revenue, up 8.2% year over year, and $302 million in operating income. Operating expenses rose 4.8% year over year, totaling nearly $4.2 billion.
    • The earnings mark the third quarter Mayo has posted net income after the operator struggled last year. The health system reported profits last year that were half its 2021 returns, after contract labor expenses increased 37% year over year. 
  • and
    • For-profit operator Tenet Healthcare has agreed to sell three of its hospitals in South Carolina for about $2.4 billion in cash to Winston-Salem, North Carolina-based Novant Health. 
    • Proceeds from the deal, which is expected to close in the first quarter in 2024, will primarily go toward paying debt, Tenet said in a news release. 
    • Under the agreement, Dallas-based Tenet’s financial services subsidiary Conifer Health Solutions will also provide revenue cycle management for the hospitals and their related operations under an expanded 15-year contract. 
  • and
    • CommonSpirit Health reported a $441 million operating loss in the first quarter of the 2024 fiscal year on increased expenses.
    • The system expects a California assistance fund — due to be approved later this fall — to offset its operational losses slightly. However, CommonSpirit’s net loss ballooned to $738 million in the quarter as investments faltered, compared to a $413 million loss same time last year, according to its earnings report filed Wednesday
    • In the report, CommonSpirit also outlined plans to expand its ambulatory care footprint next year after a string of recent outpatient acquisitions in multiple states, despite liquidity concerns.

Midweek update

Photo by Manasvita S on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “The House elected GOP Rep. Mike Johnson of Louisiana as speaker Wednesday, with the staunch conservative overcoming the divisions that had paralyzed the chamber after a band of hard-liners ousted Kevin McCarthy three weeks ago.
    • “The choice of Johnson, aligned with former President Donald Trump, came after House Republicans nominated and then dumped a series of leadership candidates, prompting some members to wonder whether any colleague could thread the needle in the deeply divided conference. With a speaker now in place, lawmakers can return to work, with many eager to pass aid for Israel and address a looming government-funding deadline next month.”
  • STAT News tells us,
    • “A Senate health panel on Wednesday voted to send President Biden’s nominee to lead the National Institutes of Health to the chamber’s floor, moving Monica Bertagnolli one step closer to taking the longtime vacant role of permanent director.
    • “The Senate HELP Committee advanced her nomination on a 15-6 vote, with many Republicans voting in support and only Chairman Bernie Sanders (I-Vt.) breaking with the Democratic caucus to vote against her. * * *
    • “Her nomination will now move to the Senate floor for a full vote, though it is unclear when that will be scheduled.”
  • The NIH National Cancer Institute shares its weekly research highlights.
  • The American Hospital Association News points out,
    • “Starting Oct. 25, consumers can preview their 2024 health coverage options at the federally facilitated Health Insurance Marketplace. Open enrollment for the 2024 marketplace runs Nov. 1 through Jan. 15, with coverage starting Jan. 1 for consumers who enroll by midnight on Dec. 15. The Centers for Medicare & Medicaid Services expects that 96% of the website’s customers will have access to three or more insurance issuers and four in five can find coverage for $10 or less per month after subsidies.”
  • FedWeek calls attention to the fact that the U.S. Office of Personnel Management’s Inspector General has released its annual report identifying top management challenges.

From the Federal Employee Benefits Open Season front, FedSmith provides a healthcare roadmap for federal retirees. Govexec provides its perspective on Open Season planning here.

From the public health front,

  • Politico reports,
    • “So far, 12 million people, or about 3.6 percent of the population, have gotten the shot in the five weeks since it hit pharmacy shelves — though reporting lags mean it’s likely a bit higher, Centers for Disease Control and Prevention Director Mandy Cohen said.
    • “More people, by far — 16 million — have gotten their annual flu vaccine, Cohen said, attributing the difference to long-held routines.”
  • From Fierce BioTech,
    • “As Americans flock to nearby orchards for festive bouts of autumn apple picking, Insulet is celebrating a particularly bountiful stateside Apple harvest itself.
    • “The diabetes device maker has earned FDA clearance for the iPhone version of an app allowing users to control their Omnipod 5 insulin pumps from their own smartphones. Meanwhile, the app has been available to Android owners since the pump’s full U.S. launch began a year ago.
    • “In Insulet’s Monday announcement about the Apple clearance, Eric Benjamin, the company’s chief product and customer experience officer, hailed the impending launch of the app as a “significant milestone in our ongoing effort to provide people with diabetes solutions that improve their lives and help them think less about diabetes.”
  • Morning Consult informs us,
    • “28% of U.S. adults said they are interested in taking prescription GLP-1 drugs like Ozempic, Mounjaro or Wegovy for weight loss, a share relatively consistent with August and April surveys. 
    • “Consumers who have heard “a lot” about the drugs, have weight-related health conditions or have higher incomes are most likely to be interested in taking the medications.
    • “The impacts of weight loss drugs on the health industry are clear, but other sectors, like food and retail, are likely to feel the effects of changing consumer preferences. Brands that create products and services to help support a more health-conscious consumer will be best-positioned to weather disruption from Ozempic or future weight loss drug innovations.”
  • Per MedTech Dive,
    • “Boston Scientific shared pivotal trial results on Wednesday that showed promising results for its drug-eluting balloon in treating patients with repeat blockages.
    • “The company’s Agent drug-coated balloon performed better than an uncoated balloon in procedures to reopen blocked arteries at one year, according to data presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 conference. Boston Scientific was the study sponsor.”
  • BioPharma Dive lets us know,
    • “Patients with Alzheimer’s disease may have another treatment option in the not-too-distant future, as newly released data appear to support a more convenient version of the closely watched medicine Leqembi.
    • “Developed by partners Eisai and Biogen, Leqembi is the only Alzheimer’s medicine of its type with a full approval from the Food and Drug Administration. It’s specifically for patients in the early stages of the disease, and is given as an hourlong, intravenous infusion once every two weeks.
    • “Eisai and Biogen have been testing whether a different form of Leqembi, an under-the-skin injection, can be as safe and effective as the already marketed version. On Wednesday, at a medical conference in Boston, researchers presented results from a study of nearly 400 participants that suggests the two forms are roughly comparable.”
  • The New York Times reports,
    • “In the year after the Supreme Court ended the constitutional right to abortion, something unexpected happened: The total number of legal abortions in the United States did not fall. Instead, it appeared to increase slightly, by about 0.2 percent, according to the first full-year count of abortions provided nationwide.
    • “This finding came despite the fact that 14 states banned all abortions, and seven imposed new limits on them. Even as those restrictions reduced the legal abortion rate to near zero in some states, there were large increases in places where abortions remained legal. Researchers said they were driven by the expansion of telemedicine for mail-order abortion pills, increased options and assistance for women who traveled, and a surge of publicity about ways to get abortions.”

From the U.S. healthcare business front,

  • Beckers Hospital Review notes, “Newsweek has released the top 600 U.S. hospitals ranked by state, sorted by a score that factors recommendations, patient experience, quality and patient-reported outcome measures.” The article identifies the top hospital on the Newsweek scale in each State and DC.   
  • Beckers Payer Issues tells us how payer accountable care organizations (ACOs) fared in 2022.
  • Beckers Hospital Review also interviews an executive from a Texas hospital about how the facility is planning to emerge from Chapter 11 bankruptcy.
  • Per Fierce Healthcare,
    • “An otherwise strong Q3 performance across HCA Healthcare’s businesses was marred by news that the for-profit’s recently integrated physician staffing joint venture will be bleeding tens of millions of dollars per quarter for the foreseeable future.”
  • and
    • “UnitedHealth Group is making a $5 million investment in Enable Ventures, a fund that aims to improve the lives of people with disabilities.
    • “The investment will back companies that can create better quality of life, offer resources to entrepreneurs with disabilities and provide support to people with disabilities who are unemployed or underemployed. Enable puts a focus on providing the technologies and tools necessary to upskill or reskill people with disabilities to help them enter or reenter the workforce, according to the announcement.
    • “Catherine Anderson, senior vice president of health equity strategy at UnitedHealth Group, told Fierce Healthcare in an interview that backing Enable aligns with the company’s broader investment strategy around health equity.”