Tuesday Tidbits

Medical / Rx research

Tuesday Tidbits

David Ermer–AHRQ, CDC, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–
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.”

Monday Roundup

David Ermer–CDC, Congress, COVID-19, Cybersecurity, FDA, Medical / Rx research, Mental health care, Obesity, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Biden is calling congressional leaders to the White House as the clock ticks toward a partial government shutdown Friday night and a Ukraine aid package remains stuck.
    • “The president has called the meeting for Tuesday, seeking to break a logjam. House and Senate leaders have been working to negotiate the details of 12 funding bills totaling $1.6 trillion for federal agencies, which have been operating on temporary extensions since Sept. 30. Funding for the Transportation Department and several other agencies expires after March 1, which would affect some housing, food and veterans’ programs; the rest expires after March 8.” 
  • STAT News reports,
    • “Congress has abandoned its attempt to reform how pharmacy middlemen operate in an upcoming package to fund the federal government, 11 lobbyists and sources following the talks told STAT.”
  • and
    • “Congress will not move forward with a controversial policy to equalize certain Medicare payments to hospitals and physicians’ offices in an upcoming government funding package, five lobbyists and sources following the talks told STAT.”
  • From an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced $36.9 million in notices of funding opportunities for grant programs supporting behavioral health services across the country. Additionally, HHS, through the Centers for Medicare & Medicaid Services (CMS), issued guidance that allows states to expand the pool of behavioral health care providers eligible for enhanced federal Medicaid funding, which will better support this critical workforce as well as improve access to care. The guidance also allows states to claim federal dollars for nurse advice lines.”
  • BioPharma Dive tells us,
    • “The Food and Drug Administration on Saturday approved Alvotech and Teva Pharmaceuticals’ Simlandi, a biosimilar of the most popular version of AbbVie’s rheumatoid arthritis drug Humira. The drug, which can be directly substituted by a pharmacist, was rejected by the FDA twice before due to manufacturing issues at a plant in Iceland.
    • “The partners didn’t announce a launch date or a price for Simlandi, which will be the 10th Humira biosimilar reach market since Amgen’s Amjevita arrived on Jan. 31, 2023. Some biosimilars have launched at a steep upfront discount while others have a list price only slightly below Humira’s to allow for negotiation over rebates.
    • “Alvotech also announced a stock sale Monday, raising around $166 million at $16.41 a share. The company had $68 million in cash and equivalents on Sept. 30, after recording losses of $275 million on $30 million in revenue through the first nine months of 2023.”
  • HR Dive informs us,
    • “A federal district court has delayed a National Labor Relations joint employer rule effective date to March 11. Friday marks the second time the start date has been delayed; NLRB previously extended a Dec. 26, 2023, start date to Feb. 26.
    • “This new rule establishes a standard for determining if two organizations are joint employers of particular employees; two entities are joint employers when they co-determine the essential terms of an individual’s employment.”
  • The Census Bureau issued a tip sheet on grandparents and co-resident grandchildren 2021.
    • “According to the 2017-2021 ACS, 5-year estimates, 8.0% of children under age 18 lived in their grandparents’ home.
    • “The proportion of children living with only their grandparents or with their grandparents and one or both parents varied across race and ethnicity. For grandchildren who lived with grandparents, it was more common to also live with both parents or their mother in the household than to live with their father or no parent in the household.
    • “Overall, about 38.6% of children under age 18 who lived with grandparents also lived with two parents. Of all race and Hispanic origin groups, Asian grandchildren had the highest percentage (70.9%) in this living arrangement.
    • “About 16.2% of grandchildren under age 18 living with grandparents were in poverty. The percentage was higher for those in grandparent-maintained households (18.6%) compared to parent-maintained households (12.1%).
    • “About 76.1% of all grandchildren under age 18 living with grandparents lived in households that received public assistance, most commonly through the school lunch program.”
  • The tip sheet drew the FEHBlog’s attention due to FEHB coverage of foster children.
  • Health Reform Beyond the Basics offers an an explanation of the ACA Summary of Benefits and Coverage

From the public health and medical research front,

  • The New York Times offers a 2024 guide to COVID symptoms and treatments.
  • CNN points out,
    • “Cases of norovirus are on the rise in the US, on par with seasonal trends, according to the most recent data from the US Centers for Disease Control and Prevention.
    • “In the week ending February 17, more than 12% of tests for norovirus – a common and very contagious virus that causes gastrointestinal symptoms – came back positive, CDC data showed. That’s up from 11.5% the week before. Cases are particularly high in the Northeast, where more than 13% of tests came back positive. Positivity rates in the region have been over 13% since late January.
    • “However, these levels are below what they were at this point last season, when about 15% of tests were positive, both nationally and in the Northeast.
    • “Outbreaks of norovirus are most common in the late fall, winter and early spring, according to the CDC.”
  • HR Daily Advisor identifies eight tips to help employees improve mental health in the face of the winter blues.
  • Medscape lets us know that “Eating more than three meals daily, eating earlier, and eating lunch as the largest meal are linked to lower body mass index (BMI) and reduced obesity risk.”
  • The National Institutes of Health announced,
    • “Results from a large clinical trial funded by the National Institutes of Health show that an intervention for anxiety provided to pregnant women living in Pakistan significantly reduced the likelihood of the women developing moderate-to-severe anxiety, depression, or both six weeks after birth. The unique intervention was administered by non-specialized providers who had the equivalent of a bachelor’s degree in psychology—but no clinical experience. The results suggest this intervention could be an effective way to prevent the development of postpartum mental health challenges in women living in low-resource settings.
    • “In low resource settings, it can be challenging for women to access mental health care due to a global shortage of trained mental health specialists,” said Joshua A. Gordon, M.D., Ph.D., Director of the National Institute of Mental Health, part of NIH. “This study shows that non-specialists could help to fill this gap, providing care to more women during this critical period.”
    • “Led by Pamela J. Surkan, Ph.D., Sc.D.(link is external), of Johns Hopkins Bloomberg School of Public Health, Baltimore, the study was conducted in the Punjab Province of Pakistan between April 2019 and January 2022. Pregnant women with symptoms of at least mild anxiety were randomly assigned to receive either routine pregnancy care or a cognitive behavioral therapy (CBT)-based intervention called Happy Mother-Healthy Baby. The researchers assessed the participants (380 women in the CBT group and 375 women in the routine care group) for anxiety and depression six weeks after the birth of their child.
    • “The researchers found that 9% of women in the intervention group developed moderate-to-severe anxiety compared with 27% of women in the routine care group. Additionally, 12% percent of women in the intervention group developed depression compared with 41% of women in the routine care group.”
  • According to BioPharma Dive,
    • “An experimental obesity drug from Boehringer Ingelheim and Zealand Pharma succeeded in a mid-stage liver disease study, the latest evidence new weight loss medicines could also help people with metabolic dysfunction-associated steatohepatitis, or MASH.
    • “Summary results disclosed Monday show that up to 83% of trial participants treated with the companies’ drug, survodutide, experienced a significant improvement in their disease without worsening liver scarring, compared to about 18% of those given placebo. The drug met its secondary study goals, notably demonstrating a benefit on liver scarring, the companies said.
    • “Boehringer and Zealand didn’t provide many other details, leaving unanswered questions about the magnitude of survodutide’s effect. The companies also didn’t describe safety findings in depth, although they noted treatment “did not show unexpected safety or tolerability issues” at any of the three doses tested. Data will be presented at an upcoming medical meeting.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Elevance Health’s CarelonRx will begin offering a weight management program, providing its members access to digital-first coaching and wellness tools.
    • “Behavioral health and social drivers of health screenings will be included in the offerings, according to a news release. The program will help members that take, as well as those that don’t take, GLP-1 medications. It will be available to ASO-integrated clients.
    • “At CarelonRx, we want to ease the complexities of weight loss and weight management, and support healthier lifestyles for our members,” said Paul Marchetti, president of CarelonRx, in a statement. “Our weight management program is unique because it considers a member’s whole health needs, including pharmacy, medical and social drivers of health data, and creates opportunities for care coordination between nutrition and exercise experts, pharmacists, physicians and health plans.”
  • and
    • “Humana tapped data automation company Veda to improve the accuracy of its provider information and ensure seniors have real-time details about in-network providers. The partnership was announced at the ViVE 2024 conference Monday morning. * * *
    • “Founded in 2015, Veda developed an AI platform that enables payers to transform and ingest provider rosters rapidly, reducing turnaround times from weeks to hours, according to the company.
    • “Veda will use its patented automation technology to analyze, verify and standardize Humana’s data to ensure the information is accurate and comprehensive, along with real-time scoring of data quality.
    • “Accurate provider data is a key component of efficient health plan operations, care delivery, interoperability, and ultimately patient satisfaction,” Meghan Gaffney, Veda co-founder and CEO, said. “By addressing the challenges that members may face with finding in-network care providers, Humana is ensuring their members have access to the timely, high-quality care they deserve.”  
    • “Veda says its platform achieves high data accuracy, ensuring quality across networks as measured by the Centers for Medicare & Medicaid Services (CMS).”
  • and
    • “The cybersecurity incident at Change Healthcare will stretch on for at least another day, according to the latest update from Optum.
    • “The company posted early Monday morning that it is taking multiple angles to get Change’s systems back online, and stressed that it has a “high level of confidence” that other systems within Optum, UnitedHealthcare and UnitedHealth Group are unaffected. * * *
    • “In a statement to CNBC, CVS Health said that while it is continuing to fill prescriptions for customers, it’s not able to process all of its insurance claims. The pharmacy giant added that there is “no indication” that its own systems have been breached.”
  • Reuters notes,
    • “Pharmaceutical companies last year launched new U.S. drugs at prices 35% higher than in 2022, reflecting in part the industry’s embrace of expensive therapies for rare diseases like muscular dystrophy, a Reuters analysis found.
    • “The median annual list price for a new drug was $300,000 in 2023, according to the Reuters analysis of 47 medicines, up from $222,000 a year earlier. In 2021, the median annual price was $180,000 for the 30 drugs first marketed through mid-July, according to a study published in JAMA.”
  • The Society for Human Resource Management relates,
    • “Millions more employees than expected are leaving the workplace in favor of retirement—a phenomenon that stands to have an outsized impact on employers.
    • “The U.S. currently has roughly 2.7 million more retirees than predicted, Bloomberg reports, according to a model designed by an economist at the Federal Reserve Bank of St. Louis. That’s up 80 percent from six months ago, when there were roughly 1.5 million more retirees than anticipated. By contrast, prior to the pandemic, there often were fewer retirees than expected.”

Weekend update

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

From Washington, DC

  • Forbes reports,
    • “Markets are watching as twin deadlines for a government shutdown are approaching on March 1 and March 8. The first deadline impacts four of twelve appropriations areas for the U.S. government, the second the remaining eight.
    • “However, it’s possible that budgets pass in the coming days that avert a shutdown. If not, another continuing resolution, as has avoided previous potential shutdowns, appears likely. Continuing resolutions give lawmakers more time to pass a new budget by essentially rolling forward prior funding measures.
    • “Currently event forecasting site Kalshi, gives an approximately 20% chance of a shutdown by March 4, and estimates that any shutdown before July might last only days. As such, expectations are that a shutdown will likely be avoided and were a shutdown to occur, it would be brief.
    • “However, if no government budget is passed before April, then the Fiscal Responsibility Act may come into effect that could have considerable impact on government spending. That would likely impact economic growth and the trajectory of government debt.”
  • MedTech Dive tells us,
    • The current system for monitoring and recalling medical devices is failing patients, physicians wrote in the journal Health Affairs on Thursday.
    • With the Government Accountability Office (GAO) reviewing device recalls, the physicians looked at the current process to generate suggestions for improving medical device safety in the U.S.
    • The physicians advised the GAO to propose ways to clear barriers to the implementation of unique device identifiers (UDIs) and assess how the FDA can better use the National Evaluation System for Health Technology.

From the public health and medical research front,

  • The Centers for Disease Control updated its Respiratory Illness Activity Levels website on February 23.
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is elevated across many areas of the country. This week, 27 jurisdictions experienced high or very high activity. This number remains stable compared to last week.
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.
    • “Influenza test positivity decreased slightly nationally but is increasing in the Northeastern, Mid-Atlantic, and Central parts of the country. COVID-19 and RSV test positivity decreased compared to the previous week.
    • “Nationally, COVID-19 wastewater viral activity levels, which reflect both symptomatic and asymptomatic infections, remain at high levels, particularly in the South, but are trending downward in other areas.”
  • The New York Times reports,
    • “A drug that has been used for decades to treat allergic asthma and hives significantly reduced the risk of life-threatening reactions in children with severe food allergies who were exposed to trace amounts of peanuts, cashews, milk and eggs, researchers reported on Sunday.
    • “The drug, Xolair, has already been approved by the Food and Drug Administration for adults and children over age 1 with food allergies. It is the first treatment that drastically cuts the risk of serious reactions — like anaphylaxis, a life-threatening allergic reaction that causes the body to go into shock — after accidental exposures to various food allergens.
    • “The results of the researchers’ study, presented at the annual conference of the American Academy of Allergy, Asthma and Immunology in Washington, were published in The New England Journal of Medicine.
    • “For a certain population of food allergy patients, this medication will be life-changing,” said Dr. Robert A. Wood, the paper’s first author and director of the Eudowood Division of Pediatric Allergy, Immunology and Rheumatology at Johns Hopkins Children’s Center.”
  • NPR Shots points out,
    • “E-bike injuries have surged, sending thousands of Americans to hospitals in recent years, new research shows. 
    • “Electronic bicycle accidents were particularly hard on riders’ heads, especially the majority of those injured who didn’t wear helmets. 
    • “Helmet use declined by almost 6 percent each year between 2017 and 2022, while the number of e-bike riders with head trauma seeking hospital care shot up 49 fold to nearly 8,000 in 2022, according to research published in JAMA Surgery on Wednesday.
    • “It’s a really significant public health problem,” said Dr. Laura Goodman, a pediatric surgeon and trauma medical director of the Children’s Hospital of Orange County, who was not involved with the study.”
  • The Washington Post explains “How to make your hearing aids more effective and less frustrating. In one study, only 29 percent of those with hearing loss used hearing aids.” 
  • Fortune Well informs us,
    • “A large study in China tracked middle-aged and older adults for 20 years, using regular brain scans, spinal taps and other tests.
    • “Compared to those who remained cognitively healthy, people who eventually developed the mind-robbing disease had higher levels of an Alzheimer’s-linked protein in their spinal fluid 18 years prior to diagnosis, researchers reported Wednesday. Then every few years afterward, the study detected another so-called biomarker of brewing trouble.
    • “Scientists don’t know exactly how Alzheimer’s forms. One early hallmark is that sticky protein called beta-amyloid, which over time builds up into brain-clogging plaques. Amyloid alone isn’t enough to damage memory — plenty of healthy people’s brains harbor a lot of plaque. An abnormal tau protein that forms neuron-killing tangles is one of several co-conspirators.
    • “The new research, published in the New England Journal of Medicine, offers a timeline for how those abnormalities pile up.
    • :The study’s importance “cannot be overstated,” said Dr. Richard Mayeux, an Alzheimer’s specialist at Columbia University who wasn’t involved in the research.
    • [However, t]he findings have no practical implications yet.”

From the U.S. healthcare business front,

  • Forbes offers very useful rankings of the largest health insurance companies by U.S. overall, individual coverage, group coverage, and by individual U.S. state.
  • Per BioPharma Dive,
    • “BioMarin Pharmaceutical is struggling to sell the first marketed gene therapy for the most common form of hemophilia, announcing on Thursday minimal revenue from the treatment, called Roctavian.
    • “In its latest earnings report, BioMarin said Roctavian generated $2.7 million in sales during the fourth quarter and $3.5 million in all of 2023, as three total patients — two in Germany and one in the U.S. — were treated last year. New CEO Alex Hardy told analysts the company is seeing progress in “market access,” but is “very mindful of the return on investment” with Roctavian.
    • “Roctavian is one of two important new products for BioMarin, which is reviewing its business under new management and deciding what research to continue supporting. The other, a drug for dwarfism called Voxzogo, is surpassing expectations. Sales totaled $146 million last quarter, more than double the previous period.”
  • CNBC reports on how “new sickle cell gene therapies are a breakthrough, but solving how to pay their high prices is a struggle.”
    • “[Michael] Goodwin [, a 36 year old man with sickle cell disease,] worries about the cost. Vertex Pharmaceuticals’ gene therapy Casgevy lists for $2.2 million, while Bluebird Bio’s treatment Lyfgenia lists for $3.1 million.
    • “I do have insurance, but … I already have medical bills,” he said.
    • “Goodwin’s hesitancy to pursue treatment is no surprise to Dr. Julie Kanter, director of the Adult Sickle Clinic at the University of Alabama at Birmingham.
    • “My guess is even if we opened the gates today to everybody getting this therapy, at most only 10% of those individuals affected by sickle cell would want this therapy,” said Kanter, who also serves as the president of the National Alliance of Sickle Cell Centers. “And even that would be too much for us to manage right this second.”
    • “More than 100,000 Americans have sickle cell disease, according to Centers for Disease Control and Prevention estimates, and between 50% and 60% of them covered are covered by the federal and state insurance program Medicaid.
    • “Kanter said it will take time to ramp up capacity and to set up facilities across the country to treat patients at scale.
    • “We really hope that having the National Alliance of Sickle Cell Centers will allow us to strengthen our centers to generally care better for people living with this disease, which we haven’t been able to do before because the cost is a problem,” she said.

Friday Factoids

David Ermer–CDC, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington DC

  • Roll Call reports on the state of FY 2024 appropriations negotiations on Capitol Hill. Your guess on the impending outcome is as good as mine.
  • The U.S. Office of Personnel Management released
    • “a new Workforce of the Future Playbook today supporting a federal workforce that is inclusive, agile and engaged, and equipped with the right skills to deliver for the American people. The Playbook provides concrete actions that agencies can take to build and equip the workforce of the future, incorporating new strategies and sharing best practices across government. 
    • “OPM is 100% invested in strengthening the federal workforce,” said OPM Director Kiran Ahuja. “This Playbook is just another example of OPM’s ongoing efforts to equip federal agencies with the tools and resources to hire the right talent and strategically plan for their future workforce. The federal government works best when we leverage the full talent of our nation and workforce – this playbook is full of useful strategies to do just that. * * *
    • “Coming soon, OPM will provide guidance through webinars, training, and technical assistance from subject matter experts to support agencies in their implementation of these strategies. The Playbook will serve as the building block for a future workforce that promotes increased effectiveness and efficiency in service to the American people. Periodic updates will be posted to the Workforce of the Future webpage.” 
  • The Department of Justice announced,
    • “Settlements and judgments under the False Claims Act exceeded $2.68 billion in the fiscal year ending Sept. 30, 2023, Acting Associate Attorney General Benjamin C. Mizer and Civil Division Principal Deputy Assistant Attorney General Brian M. Boynton announced today. The government and whistleblowers were party to 543 settlements and judgments, the highest number of settlements and judgments in a single year. Recoveries since 1986, when Congress substantially strengthened the civil False Claims Act, now total more than $75 billion. * * *
    • “Of the more than $2.68 billion in False Claims Act settlements and judgments reported by the Department of Justice this past fiscal year, over $1.8 billion related to matters that involved the health care industry, including managed care providers, hospitals, pharmacies, laboratories, long-term acute care facilities, and physicians. The amounts included in the $1.8 billion reflect recoveries arising only from federal losses, but in many of these cases, the department was instrumental in recovering additional amounts for state Medicaid programs. The recoveries in fiscal year 2023 also reflect the department’s focus on key enforcement priorities, including fraud in pandemic relief programs and alleged violations of cybersecurity requirements in government contracts and grants.”
  • Medscape informs us,
    • “The Food and Drug Administration has granted De Novo classification to a sleep apnea feature developed by Samsung for use via the Health Monitor app, according to a company press release.
    • “The sleep apnea feature will be available on watches in Samsung’s Galaxy series in the third quarter of 2024, according to the press release.
    • “The new feature on the app is designed to help users with no previous diagnosis of sleep apnea to detect moderate to severe symptoms over a two-night period.
    • “The sleep apnea feature allows individuals older than 22 years to track their sleep twice for more than 4 hours within a 10-day period. The feature identifies breathing disruptions.”
  • MedTech Dive adds,
    • “The Food and Drug Administration warned patients against using smartwatches or smart rings that claim to measure blood sugar without piercing the skin. 
    • “Officials published the safety notice Wednesday after learning that people are selling wearables that claim to noninvasively monitor blood glucose. The devices are “manufactured by dozens of companies and sold under multiple brand names,” according to the agency. 
    • “The FDA has never authorized a noninvasive wearable that measures or estimates blood glucose values on its own and is concerned inaccurate readings could lead to errors in the management of diabetes.”
  • Govexec reports,
    • “The U.S. Postal Service has continued to see slower mail delivery across the country, with delays picking up as the agency is in the throes of transforming its entire network. 
    • “Postal management has repeatedly pointed to isolated incidents causing temporary disruptions—rather than any systemic issues—to explain the declining performance, though the trend has now persisted for nearly six months and is causing stakeholders and advocates to question the true root of the problem.
    • “USPS is now delivering just 83% of First-Class mail on time during the current fiscal quarter, its worst rate in three years. That is down from 86% in the first quarter and 91% in both the fourth quarter of fiscal 2023 and the same period last year.”

From the public health and medical research front,

  • The Centers for Disease Control tells us about the changing threat of Covid-19
    • What CDC knows
    • The impact of SARS-CoV-2, the virus that causes COVID-19, has changed dramatically since 2020. Although COVID-19 remains common, when compared to 2020, individual infections are less likely to result in severe illness for most people in the United States. COVID-19 poses the highest risk for older adults, infants, and people with pre-existing medical conditions, and there are multiple ways people and communities can help reduce their risk of infection.
    • What CDC is doing
    • CDC continues to partner with state and local health authorities to collect and share data on COVID-19 community spread, hospitalizations, deaths, and Long COVID.  Additionally, CDC continues to evaluate the effectiveness of prevention and treatment strategies for the virus in order to provide the public the best evidence-based recommendations for reducing their risk from COVID-19.
    • Keep reading: The Changing Threat of COVID-19
  • Medscape notes,
    • Exercising for upwards of 30 minutes most days may help relieve pain in patients who’ve been diagnosed with cancer, according to a study of exercise and pain outcomes from more than 60,000 people, including 10,000 with a history of cancer. 
    • Study participants who’d been diagnosed with cancer and surpassed 150 minutes of moderate activity a week were 16% less likely to report pain than those who did not exercise or who exercised less. Exercise was particularly helpful for those with moderate to severe pain. In general, the more people exercised, the less pain they felt — and that was true for those with and without a history of cancer.
    • “This adds to a large evidence base regarding other benefits of exercise after cancer,” said lead study author Christopher Swain, PhD, a researcher at the University of Melbourne, Australia, who studies how physical activity can protect against cancer. “It would be great for physicians to encourage physical activity” for anyone who’s ever been diagnosed with cancer. 
  • Axios reports,
    • “Americans see poor mental health as one of the biggest threats to public health, ranking just behind obesity and the long-running opioid epidemic, according to the latest Axios-Ipsos American Health Index.
    • “The big picture: Almost 9 out of 10 people say their own emotional wellbeing is very or somewhat good, but they view mental health issues as a serious societal threat that now outranks access to firearms, cancer or COVID-19. 
    • “And unlike many other perceived threats, there’s a pronounced generational split about mental health, registering as a much bigger concern for younger adults.
    • “The poll also found all but a small pocket of Americans largely tuned out a winter COVID-19 wave that saw the second-largest number of cases since the start of the pandemic, and the public is skeptical about handing over their care to artificial intelligence.
    • “By the numbers: Overall, 17% said mental health was the top threat to public health, while 19% said obesity, 24% said opioids and fentanyl, and 15% said it was access to guns.”

From the U.S. healthcare business front,

  • The Employee Benefit Research Institute announced,
    • “New findings released today from the Employee Benefit Research Institute (EBRI)/Greenwald Research Consumer Engagement in Health Care Survey(CEHCS) reported that consumers were overall satisfied with their health plan selection and services, while high deductible plans showed a slight decline in enrollment.
    • “The CEHCS is a survey of privately insured adults that has been conducted annually since 2005. The survey provides reliable national data on the growth of high deductible health plans (HDHP), consumer driven health plans (CDHP) and health savings accounts (HSA) – and the impact on the behavior and attitudes of health care consumers.  The 2023 survey of 2,020 individuals was conducted using an online research panel between Oct. 16 – Dec. 11, 2023. All respondents were between the ages of 21 and 64. * * *
    • “This year’s survey really shows strong evidence that people overall are satisfied with their health insurance.  Satisfaction levels are steady.  We see no majority is complaining and that is key to understanding market needs,” said Paul Fronstin, Ph.D., director, Health Benefits Research, EBRI.
    • “To view the 2023 CEHCS summary report, visit https://www.ebri.org/cehcs-2023.”
  • Chief Healthcare Executive reports,
    • “Nonprofit hospitals are making some progress financially, although the gains remain modest, according to Fitch Ratings.
    • “Of course, it’s saying something that Fitch’s early projections for the 2023 calendar year continue to show operational declines, although they aren’t as steep as 2022.
    • “Overall, Fitch expects the 2023 operating margins to rise into positive territory, albeit barely. The 2023 margins are expected to rise to 0.5% to 0.7%, which remains below pre-pandemic levels.
    • “In 2024, Fitch projects margins should move up to 1.6%.”
  • MedPage Today discusses whether “Artificial intelligence can improve prior authorization.”
    • “Prior authorization has ripple effects on patients and clinicians, but artificial intelligence (AI) has the potential to simplify the process, health policy experts said during an online panel discussion hosted by the Kaiser Family Foundation on Thursday.
    • “Troyen Brennan, MD, a former executive at CVS Care and an adjunct professor at the Harvard T.H. Chan School of Public Health in Boston, defended the process, arguing that it cuts down on unnecessary care. About 15% to 30% of all care in the U.S. healthcare system is ineffective, Brennan said.
    • “Plus, there are “really not any good studies … showing actual harm,” he argued. “There are a lot of surveys from physicians, in particular, that say that there are tremendous delays, but there’s obviously a response bias associated with this.”

Thursday Miscellany

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

From Washington, DC,

  • American Hospital Association (AHA) News reports,
    • “AHA Feb. 22 voiced support for the Child Suicide Prevention and Lethal Means Safety Act (H.R. 7265), legislation that would provide funding for training programs to help health care workers identify patients at high risk for suicide or self-harm. The bill would also provide grants to facilitate suicide prevention training at health professions schools.”  
  • and
    • “Senate Health, Education, Labor & Pensions Committee Ranking Member Bill Cassidy, R-La., Feb. 21 released a report proposing ways to modernize the existing HIPAA framework and protect health and other data not covered by HIPAA. Responding to Cassidy’s request for information on the issue last year, AHA asked Congress to urge the Department of Health and Human Services’ Office for Civil Rights to immediately withdraw a rule that would violate HIPAA and its implementing regulations; explore how to better require entities not covered by HIPAA to protect patient privacy; and strengthen HIPAA preemption.”
  • Roll Call tells us,
    • “The House Democratic Women’s Caucus has asked the biggest insurance association to urge insurers to comply with contraceptive coverage requirements and Biden administration guidance issued in January, according to a letter shared first with CQ Roll Call. * * *
    • “The Democratic Women’s Caucus wrote to AHIP President and CEO Mike Tuffin on Thursday urging the group to have its members follow the suggestions HHS outlined. 
    • “Despite repeated clarification of these requirements from the Departments, multiple investigations — including by the House Oversight Committee — have revealed that plans routinely violate the [2010 health care law] by refusing to cover certain products, imposing administrative hurdles like prior authorizations and step therapy (fail first protocols), and requiring patient cost-sharing,” wrote the 143 House members as well as 13 senators.
    • “The members asked Tuffin to respond if insurance plans will be adopting the standard and when; how plans that will not adopt the standard intend to comply with the coverage requirement and if any member plans have been using techniques to deny coverage as described in the HHS guidance. 
    • “The letter also seeks clarity on which plans have an exceptions process publicly available on their websites for when a therapeutically equivalent product does not work for a patient.
    • “The letter requests a response by March 1.”
  • MedTech Dive notes,
    • Better Therapeutics has received breakthrough device status for a digital therapeutic designed to treat adults with advanced liver disease, the company said Tuesday.
    • The Food and Drug Administration awarded the designation after seeing the results of a clinical trial that linked the digital cognitive behavioral therapy (CBT) to reductions in liver fat.
    • Better Therapeutics won FDA authorization in Type 2 diabetes in July but, like the wider digital therapeutics sector, has struggled to allay concerns about commercialization. The company has discussed substantial doubts about its ability to continue as a going concern. 
  • Mercer Consulting projects “the 2025 inflation-adjusted amounts for health savings accounts (HSAs), high-deductible health plans (HDHPs) and excepted-benefit health reimbursement arrangements (HRAs) will all rise from 2024 levels. These unofficial 2025 amounts are determined using the Internal Revenue Code (IRC)’s cost-of-living adjustment methods, the US Bureau of Labor Statistics (BLS) published Chained Consumer Price Index for All Urban Consumers (C-CPI-U) values through January 2024, and Mercer’s projected C-CPI-U values for February and March.”
  • “The U.S. Preventive Services Task Force posted today a final research plan on screening for HIV. The draft research plan for this topic was posted for public comment from November 30, 2023, to January 3, 2024. The Task Force reviewed all of the comments that were submitted and took them into consideration as it finalized the research plan. To view the final research plan, please go here.”

From the public health and medical research front,

  • MedPage Today calls our attention to the following
    • “More than 134,000 cancers might have gone undiagnosed during the first 10 months of the COVID-19 pandemic, according to a study of national trends in cancer incidence.
    • “Annual cancer incidence fell almost 30% short of the expected rate from March through December 2020. The difference represented potentially 134,395 undiagnosed cancers during that period. Diagnosis of early- and late-stage cancers declined. Prostate, breast, and lung cancers accounted for the most potential missed cases. Overall, rates of “screenable” cancers decreased by 13.9% versus expected rates. * * *
    • “It is important that we continue to evaluate the trends identified in this study as U.S. cancer incidence data for years after 2020 become available,” the authors wrote. “Pandemic-associated disruptions will continue to affect rates of cancer incidence, and how long it will be until we fully recover is still unknown.”
    • “Beyond incidence, it is important that we measure the pandemic’s contribution to future trends in cancer mortality and survival,” they added. “With a near 10% reduction from expected rates in overall late-stage incidence from March to December 2020, there will undoubtedly — and unfortunately — be a subsequent rise in cancer mortality. How substantial a rise and for how long will provide a more complete picture of the consequences of COVID-19 disruptions on the burden of cancer in the U.S.”

The Wall Street Journal reports that “There’s No Easy Way to Stop Taking Ozempic. Those who go off weight-loss drugs risk regaining weight, but staying on them forever isn’t always a realistic option.” Quite a conundrum. The article discusses approaches to stopping the medicine and alternatives, such as bariatric surgery.

  • The National Institutes of Health announced,
    • “A research project supported by the National Institutes of Health has developed a tool to rapidly and inexpensively diagnose sarcoidosis, a chronic inflammatory disease marked by the growth of tiny lumps called granulomas in the lungs and other organs in the body. The tool, which uses a simple blood test, could allow for selective use of more invasive diagnostic tests often used to identify the disease. The findings published in the American Journal of Respiratory and Critical Care Medicine.
    • “Currently, diagnosing sarcoidosis isn’t a straightforward process, and requires tissue removal and testing with additional screenings to rule out other diseases, such as tuberculosis or lung cancer,” said James Kiley, Ph.D., Director of the Division of Lung Diseases at the National Heart, Lung, and Blood Institute, part of NIH. “Using a blood test will help diagnose faster, particularly in those organs that are more challenging to biopsy and with less harm to the patient.”
  • The NIH Director, in her blog discusses “A Potential New Way to Prevent Noise-Induced Hearing Loss: Trapping Excess Zinc.”
    • “Hearing loss is a pervasive problem, affecting one in eight people aged 12 and up in the U.S.1 While hearing loss has multiple causes, an important one for millions of people is exposure to loud noises, which can lead to gradual hearing loss, or people can lose their hearing all at once. The only methods used to prevent noise-induced hearing loss today are avoiding loud noises altogether or wearing earplugs or other protective devices during loud activities. But findings from an intriguing new NIH-supported study  exploring the underlying causes of this form of hearing loss suggest it may be possible to protect hearing in a different way: with treatments targeting excess and damaging levels of zinc in the inner ear.”
  • STAT News points out “Embryo loss is integral to [in vitro fertilization] IVF. [The] Alabama ]Supreme Court]’s ruling equating embryos with children jeopardizes its practice.” For more information, listen to this Advisory Opinions podcast from the Dispatch.

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Fourteen organizations representing providers, payers, consumer technology companies and employers are teaming up to cut through the noise and raise higher standards for finding digital health solutions that work and are worth the investment.
    • “The new Digital Health Collaborative, supported by the Peterson Health Technology Institute, brings together provider groups, purchasers and end users and initial work will focus on pulling together a national purchaser survey, grantmaking and convenings, the organization said.
    • “The Peterson Health Technology Institute formed in July 2023, armed with $50 million in funding, to evaluate digital health technologies and help cut through the hype to identify innovations that actually benefit patients. PHTI focused on providing independent, evidence-based assessments of emerging products, something that is currently lacking in the market.”
  • BioPharma Dive tells us,
    • “Moderna shares rose by as much as 10% Thursday morning after the COVID-19 vaccine developer reported fourth quarter profit that beat Wall Street expectations of a net loss during the final three months of 2023.
    • “Full-year sales of $6.7 billion matched estimated numbers Moderna disclosed in January, but were down by about two-thirds versus 2022 as COVID vaccination rates declined substantially last year. The company has restructured its manufacturing operations in response to match the lower demand.
    • “Moderna forecasts $4 billion in sales this year, with some expected to come from an experimental vaccine for respiratory syncytial virus that’s under regulatory review in the U.S. and several other countries.”
  • McKnight’s Long Term Care News lets us know,
    • “A shortage of registered nurses in the first two years of the pandemic was probably temporary, according to a new report. That’s because the workforce rebounded in 2022 and 2023, the authors said. Even still, a lot of RNs aren’t going back to hospitals and are moving into other settings including nursing homes and long-term care communities, authors of the report said.
    • “The study, published on Feb. 16 in JAMA Health Forum, noted that the workforce of RNs fell by about 100,000 employees in 2021. That decrease was the largest drop in a single year in the past 40 years. In 2022, hiring started to go back up, according to data from the US Bureau of the Census Current Population Survey. 
    • “The data included RNs between the ages of 23 and 69 who were employed between 1982 and 2023. The researchers also used another cohort of data on employment trends by birth year and age to project the age distribution and employment of RNs through the year 2035. There were 455,085 RNs included in the study. In 2022 and 2023, there were 3.35 million full-time RNs, which is 6% higher than in 2019 when there were 3.16 million nurses.”
  • Per Healthcare Dive,
    • “Walgreens is planning to close its remaining VillageMD clinics in Florida as the beleaguered retail giant continues to cut costs.
    • “VillageMD operated 52 clinics in Florida, but 14 have closed to date. The remainder will shutter by March 15, according to multiple news reports citing Walgreens. The closures fully exit VillageMD from Florida, one of its largest markets and a key target for value-based primary care chains given the state’s large population of elderly patients with chronic health needs.
    • “Walgreens did not share details of what’s driving the closures. But analysts say Walgreens may have struggled getting enough doctors and patients into the smaller clinics, which are co-located within Walgreens stores.”
  • Beckers Hospital News notes,
    • “Grubhub has teamed up with CVS Pharmacy to deliver health and wellness products to consumers in 48 states. 
    • “Grubhub users can now access thousands of products on the mobile ordering and delivery platform from more than 6,000 CVS locations nationwide. * * *
    • “CVS is the second national drugstore chain to partner with Grubhub, behind Rite Aid. Walgreens has also teamed up with Doordash and Uber to deliver medications and other health products.”
  • Per HR Dive,
    • “Business advocates and the U.S. Department of Labor can resume their fight over independent contractor regulations, the 5th U.S. Circuit Court of Appeals decided Monday (Coalition v. Su).
    • “The litigation began after the Biden administration in 2021 nixed a Trump-era rule on the issue. Business groups challenged that withdrawal, arguing DOL overstepped its authority. A federal district court judge agreed, and the Biden administration appealed that ruling to the 5th Circuit. The appeals court issued a stay pending DOL’s publication of a new rule.
    • “Biden’s DOL finalized its own version of the regulations in January, with a March 11 effective date, leading the 5th Circuit to lift its stay Monday at the request of the business groups. The court also vacated the lower court’s opinion at DOL’s request, sending it back for the court to revisit.
    • “Considering this and other litigation related to the new regulations, a court could very well put the upcoming rules on hold, an employment law attorney told HR Dive last month; but with the effective date just weeks away, employers should monitor developments closely, he said.”

Midweek Update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, OPM, SDOH, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Politico reports,
    • “Congress is out of town this week and facing another government shutdown deadline with major health care implications.
    • “Lawmakers are confronted with two deadlines — March 1 for funding for the FDA and the VA and March 8 for HHS funding.
    • “It’s a key week for Congressional appropriators. How much progress they make now will determine whether lawmakers have to turn to another temporary spending package.
    • E”ven though Congress is away, negotiations continue, and key lawmakers are “encouraged” about the prospect of reaching a deal.
    • “But as POLITICO’s Caitlin Emma and Jennifer Scholtes report, there’s skepticism about whether the progress is being made quickly enough, according to sources familiar with the talks. Legislative text for some fiscal 2024 measures should ideally be finalized by this weekend to allow time for the Congressional Budget Office to pore over the bills and top lawmakers to calculate their next steps.”
  • Govexec offers a Kevin Moss article about OPM’s recent call letter for 2024 benefit and rate proposals for FEHB and PSHBP coverage. Bear in mind that the article does not appreciate the fact the Part D EGWP plans integrate Medicare and FEHB / PSHB coverage so that if Medicare does not cover a particular drug, like an obesity treatment, the FEHB / PSHB coverage will kick in.
  • FEDWeek discusses an OPM Inspector General report criticizing OPM’s FEHB disputed claims resolution process. The FEHBlog thinks that OPM does a good job with this process. Of course, any process can be improved but at what cost?
  • Healthcare Dive tells us,
    • “The CMS finalized a rule on Tuesday recalculating disproportionate share hospital payments, or reimbursements for hospitals serving a high proportion of low-income patients. Under the new definition, hospitals can only receive reimbursements for services rendered to beneficiaries for whom Medicaid is their primary insurer. 
    • “Congress tasked the CMS with clarifying DSH calculations in its Consolidated Appropriations Act of 2021. The final rule aims to reduce DSH overpayments by limiting hospitals’ ability to receive government and private payer funds for the same service, according to the rule.
    • I”n total, the CMS’ new calculations will result in an $8 billion reduction in DSH payments annually from fiscal year 2024 to 2027, according to the rule.” 
  • Assistant Secretary of Labor for Employee Benefit Security, Lisa Gomez, posted a blog entry about how to use your employer sponsored health benefits to improve heart health.
  • The Government Accountability Office issued a report on maternal health.
    • “Hundreds of women in the U.S. die each year from complications related to pregnancy and childbirth—a crisis exacerbated by COVID-19. The Department of Health and Human Services is working to address the crisis and meet long-term goals such as increasing women’s access to high-quality maternal care.
    • “As of September 2023, HHS hasn’t determined how it’ll measure progress toward achieving its maternal health goals. Following key performance measurement practices—such as setting near-term goals and establishing timeframes for results—would allow the agency to better understand if its efforts are effective. We recommended that HHS do so.”
  • The National Institutes of Health announced,
    • “launch[ing] a clinical trials network to evaluate emerging technologies for cancer screening. The Cancer Screening Research Network (CSRN) will support the Biden-Harris administration’s Cancer Moonshot℠ by investigating how to identify cancers earlier, when they may be easier to treat. Eight groups have received funding from the National Cancer Institute (NCI), part of NIH, to carry out the initial activities of the network.
    • “There are many cancers we still cannot reliably detect until it is so late that they become extremely difficult to treat,” said W. Kimryn Rathmell, M.D., Ph.D., director of NCI. “Emerging technologies such as multi-cancer detection tests could transform cancer screening and help to extend the lives of many more people. We need to be sure that these technologies work and understand how to use them so they benefit everyone.”
    • “Studies are needed, for example, to evaluate the benefits and harms of promising new technologies for cancer screening and to determine how best to incorporate these technologies into the standard of care.”
    • “In 2024, the network will launch a pilot study, known as the Vanguard Study on Multi-Cancer Detection, to address the feasibility of using multi-cancer detection (MCD) tests in future randomized controlled trials. MCDs are blood tests that can screen for several types of cancers. The study will enroll up to 24,000 people to inform the design of a much larger randomized controlled trial. This larger trial will evaluate whether the benefits of using MCD tests to screen for cancer outweigh the harms, and whether they can detect cancer early in a way that reduces deaths.”

From the public health and medical research front,

  • KFF informs us,
    • The United States is knee-deep in what some experts call the opioid epidemic’s “fourth wave,” which is not only placing drug users at greater risk but is also complicating efforts to address the nation’s drug problem.
    • These waves, according to a report out today from Millennium Health, began with the crisis in prescription opioid use, followed by a significant jump in heroin use, then an increase in the use of synthetic opioids like fentanyl.
    • The latest wave involves using multiple substances at the same time, combining fentanyl mainly with either methamphetamine or cocaine, the report found. “And I’ve yet to see a peak,” said one of the co-authors, Eric Dawson, vice president of clinical affairs at Millennium Health, a specialty laboratory that provides drug testing services to monitor use of prescription medications and illicit drugs. * * *
    • Methamphetamine, a highly addictive drug often in powder form that poses several serious cardiovascular and psychiatric risks, was found in 60% of fentanyl-positive tests last year. That is an 875% increase since 2015. * * *
    • Among the report’s other key findings:
      • The nationwide spike in methamphetamine use alongside fentanyl marks a change in drug use patterns.
      • Polydrug use trends complicate overdose treatments. For instance, though naloxone, an opioid-overdose reversal medication, is widely available, there isn’t an FDA-approved medication for stimulant overdose.
      • Both heroin and prescribed opioid use alongside fentanyl have dipped. Heroin detected in fentanyl-positive tests dropped by 75% since peaking in 2016. Prescription opioids were found at historic low rates in fentanyl-positive tests in 2023, down 89% since 2013.
  • MedPage Today points out,
    • “Annual breast cancer screening at ages 40 to 79 resulted in the greatest reduction in mortality, according to a study comparing various screening scenarios.
    • “Using Cancer Intervention and Surveillance Modeling Network (CISNET) estimates of breast cancer screening outcomes published in 2009, 2016, and 2023, mortality was reduced by 41.7% with annual screening starting at age 40 and continuing up to age 79, reported Debra L. Monticciolo, MD, of Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, and colleagues.”
  • AP reports,
    • “Emily Hollenbeck lived with a deep, recurring depression she likened to a black hole, where gravity felt so strong and her limbs so heavy she could barely move. She knew the illness could kill her. Both of her parents had taken their lives. 
    • “She was willing to try something extreme: Having electrodes implanted in her brain as part of an experimental therapy.
    • “Researchers say the treatment —- called deep brain stimulation, or DBS — could eventually help many of the nearly 3 million Americans like her with depression that resists other treatments. It’s approved for conditions such as Parkinson’s disease and epilepsy, and many doctors and patients hope it will become more widely available for depression soon.”
  • Fierce Healthcare lets us know,
    • “Given the impact that social factors have on overall health, employers can better manage costs and outcomes by embracing deeper, population-level data analysis, according to a new white paper.
    • “UnitedHealthcare and the Health Action Council (HAC), a nonprofit that represents large and midsize employers, dug into community health data from HAC’s plan sponsors representing 217,779 workers. The analysis found that 52% of adults have at least one social determinant of health risk.
    • “Of that group, 10% faced three or more risks, and 16% had two risk factors. Twenty-six percent have one SDOH risk factor, according to the report.
    • “Craig Kurtzweil, chief data and analytics officer for UnitedHealthcare Employer and Individual, told Fierce Healthcare that the study “gives us a first of its kind sort of view of all the different variables that are impacting the health of various communities and employers.”
    • “As you dive a little bit further, it just becomes a bit remarkable how much of an impact those factors are making,” he said.”
  • Becker’s Hospital Review brings us up to date on prescription drug shortages.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “St. Louis-based Ascension Healthcare brought in $231 million in operating income during its second quarter 2024 ended Dec. 31, compared to an operating loss of $291 million during the prior-year period.
    • “Ascension attributed its operational improvement in part to volume growth. Inpatient admissions increased 0.5% in thesix months ended Dec. 31, with same-facility admissions increasing 1.2% for the same period year over year.
    • “The health system said it slowed the pace of expense growth during the quarter. Total salaries, wages and benefits decreased $152 million in the six months ended Dec. 31, totaling $54.9 million for the quarter, as Ascension outsourced lab services and continued retention programs to reduce dependence on pricey staffing agencies.”
  • STAT News notes,
    • “DarioHealth, which makes apps for managing chronic diseases, today announced it will acquire digital mental health company Twill for $10 million in cash plus stock valued at over $20 million at the end of Tuesday trading. The move is a bet that a consolidated offering can attract a critical mass of large customers in a market where profits have been elusive.
    • “Founded in 2011, Dario started with a diabetes app targeted at consumers before expanding it to hypertension and weight management. It still maintains that direct-to-consumer business but has since shifted its focus to selling its suite of offerings, including a musculoskeletal care program it acquired in 2021, to health plans and employers in the hopes of reaching much larger patient populations. Recent updates aimed at making itself attractive to clients include a new offering built around popular, and expensive, GLP-1 weight loss drugs, and published real world data suggesting its tools can save clients money on downstream health care costs. With Twill, Dario adds a mental health app and related services, addressing a top demand of employers.”
  • Per Fierce Healthcare,
    • “Teladoc offered a weaker-than-expected forecast for 2024, projecting slower revenue growth as the telehealth market has become crowded with digital health players.
    • “The virtual care giant pulled in $661 million in revenue in the fourth quarter of 2024, up 4% from $638 million in the same period a year ago. Access fees revenue grew 4% to $574 million, and other revenue grew 3% to $87 million. U.S. revenue grew 2% to $565 million, and international revenue grew 15% to $96 million.
    • “The company’s BetterHelp virtual mental health business saw flat growth in the fourth quarter, bringing in $277 million. The weakness in BetterHelp sales was the result of lower direct-to-consumer marketing yield.
  • Beckers Payer Issues offers an interview with an Aetna Executive about the company’s Medicare Advantage business.
  • MedCity News calls our attention to a continuing interoperability problem.
    • “The healthcare industry has notoriously struggled with disconnected data systems and a lack of interoperability. When health information cannot be easily exchanged between different systems and providers, it leads to fragmented care, medical errors and delays in treatment — not to mention an incredible amount of frustration and inconvenience for both providers and patients.
    • “Software developers have been working hard in recent years to create tools and data sharing standards that foster a more cohesive and integrated approach. However, these tools have a serious adoption problem, experts said last week during a virtual panel held by Reuters Events.
    • “Alistair Erskine, Emory Healthcare’s chief information and digital officer, pointed out that most provider referrals are still done by fax, even though there are tools available to send them digitally. Most providers use EHRs that are able to pull a patient’s health information and transport it to the EHR of the new provider to whom they’ve been referred, he said.
    • “Despite data sharing standards like FHIR and DICOM — and despite “the fact that the data has already been digitized” — completing a provider referral is still not a smooth process, Erskine remarked. He stated that 98% of referrals are done by fax even though they could “of course” be done electronically.
    • “Even though the standards are there, we have to make sure that people safely log into their systems, and we have to make sure that people are able to find their patient in their systems. And if you navigate from one system to the next, that presents a barrier to entry. It’s easier to just take a piece of paper, write what you need and send it in a fax,” Erskine explained.”

Tuesday Tidbits

David Ermer–Congress, COVID-19, Medical / Rx research, Mental health care, NIH, No Surprises Act, Rx coverage, SDOH, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Beckers Health IT informs us,
    • “U.S. lawmakers introduced bipartisan legislation Feb. 16 to better match patients with their EHRs.
    • “U.S. Reps. Mike Kelly, R-Pa., and Bill Foster, PhD, D-Ill., sponsored the Patient Matching and Transparency in Certified Health IT, or MATCH IT, Act of 2024.
    • “Patient matching errors have led to unnecessary expenses, medical mistakes, and even patient deaths,” Mr. Kelly said in a Feb. 16 news release. “This bipartisan legislation works to improve interoperability between healthcare systems and decrease these fixable matching errors, all while protecting patient privacy.”
  • STAT News tells us,
    • “Nearly four decades after its first conception, the first TIL therapy, an immunotherapy that harvests cancer-fighting immune cells from the patient’s own body, received accelerated approval from the Food and Drug Administration for advanced melanoma. The therapy, called Amtagvi or lifileucel from Iovance, is the first cell therapy approved for a solid tumor.
    • “It’s so exciting and gratifying,” said Allison Betof Warner, a cell therapy researcher and physician at Stanford University who has worked on Amtagvi. “This is a game-changing moment for our field. We’ve seen huge success of cellular therapy for hematologic malignancies, and we’ve yet to capitalize on that for solid tumors. This is hopefully the first of many to come.”
    • “In a Phase 2 clinical trial, titled C-144-01, 153 patients who had already been on a median of three prior lines of therapy received lifileucel, and 31% of them responded to therapy. “These are in very late line patients. They’ve exhausted every standard care option,” Betof Warner said. “The most promising part of this therapy for me is that 42% of patients who responded were still responding for 18 months or longer. It’s truly incredible.”
    • “The therapy is not expected to work for every patient, partially because the regimen has high toxicity. It will also be expensive. The therapy is expected to be priced at $515,000.”
  • Beckers Hospital Review adds, “Buzz for gene therapies is loud, but drugmakers struggle to get treatments off the ground.”
    • “A major barrier for many companies in the space is sheer cost to develop these advanced medical therapies. Though the Biden administration and CMS announced Jan. 30 plans to bring down prices for gene edited therapies, progress will take time. 
    • “The number of patients being treated with the existing gene therapies that are approved and available on the market is expected to decline year over year by nearly 33%, according to Bloomberg.”
  • Per the Food and Drug Administration,
    • “On Friday, the FDA published an Outbreak Advisory for an investigation of E. coli O157:H7 linked to raw cheddar cheese. The FDA recommends that consumers, restaurants, and retailers do not eat, sell, or serve Raw Farm-brand Raw Cheddar Cheese (block or shredded) and to throw it away. This is an ongoing investigation and the FDA will update the Advisory should additional consumer safety information become available.”
  • BioPharma Dive reports,
    • “AstraZeneca’s targeted cancer therapy Tagrisso can now be used alongside chemotherapy to treat a common type of locally advanced or metastatic lung tumor, following a Food and Drug Administration approval Friday.
    • “The FDA cleared Tagrisso together with chemotherapy based on results showing the combination reduced the risk of disease progression or death versus Tagrisso alone, which is currently the first-line standard for non-small cell lung cancer that harbors mutations in a gene known as EGFR.
    • “Over the weekend, meanwhile, AstraZeneca reported new clinical trial data showing Tagrisso outperformed placebo following chemoradiotherapy for Stage 3 EGFR-mutated non-small cell lung cancer that couldn’t be surgically removed. The results, which AstraZeneca will share with regulators, could further support early use of Tagrisso.”

From the public health and medical research front,

  • Axios points out,
    • “More than half of U.S. newborns now appear to be protected by new RSV vaccines, according to updated Centers for Disease Control and Prevention data.
    • “Why it matters: The virus is considered the second leading cause of death worldwide during the first year of a child’s life. The data suggests demand was strong despite broader vaccine skepticism and the potential for confusion over more childhood immunization options.”
  • The Wall Street Journal discusses a related RSV vaccine (Beyfortus) shortage — “A new antibody that protects babies from a deadly virus proved far more popular than drugmaker Sanofi expected.”
    • Beyfortus seller Sanofi in March last year set aggressive targets for how many doses to make, yet still underestimated demand. Some pediatricians delayed ordering immunizations because they didn’t know whether insurers would cover the $495 doses. And the U.S. government decided in August—months after Sanofi had locked in the number of doses it would make—to add the shot to the Vaccines for Children program, a federal initiative that covers children who are uninsured or on Medicaid, buying more than half of the doses.
    • Sanofi said it sought to distribute its shots equitably in the face of “unprecedented” demand and is working to increase supply for the next RSV season. 
  • HHS’s Agency for Healthcare Quality and Research issued a Medical Expenditure Panel Survey about “Characteristics of Young Adults Aged 18-24 Who Had Ever Used an Electronic Nicotine Product, 2021.”
    • “Nearly one-third (30.6 percent) of U.S. adults ages 18-24 reported ever having used an electronic nicotine product.
    • “More than one-third (38.3 percent) of non-Hispanic White young adults reported ever having used an electronic nicotine product, nearly double the rate for Hispanic young adults and 12 percentage points higher than for non-Hispanic Black young adults.”
  • Medpage Today notes,
    • “Nearly all medication abortions obtained via telehealth, whether via video or secure text messaging, were completed without further intervention and without adverse events, the prospective CHAT study found.
    • “Among over 6,000 abortions, 97.7% (95% CI 97.2-98.1) were completed without further intervention, and the completion rate was similar for patients who had video calls (98.3%) or used text messaging (97.4%), reported Ushma Upadhyay, PhD, MPH, of the University of California San Francisco, and colleagues.
    • “Less than 1% of patients had a serious abortion-related adverse event (0.25%) or were treated for an ectopic pregnancy (0.16%), and 1.3% of abortions were followed by emergency department visits, the authors wrote in Nature Medicine.”
  • The FEHBlog has subscribed to a Substack series called “Your Local Epidemiologist.”
    • “Your Local Epidemiologist (YLE)” is written by Dr. Katelyn Jetelina, M.P.H. Ph.D.—an epidemiologist, wife, and mom of two little girls. During the day, she is a senior scientific consultant to several organizations, including CDC. At night, she writes this newsletter. Her main goal is to “translate” the ever-evolving public health world so that people will be well-equipped to make evidence-based decisions. This newsletter is free, thanks to the generous support of fellow YLE community members.”
    • Check it out.
  • Medpage Today offers an expert medical opinion concerning
    • “News surfaced last week suggesting a potential shift in COVID-19 isolation guidanceopens in a new tab or windowfrom the CDC. The planned guidance, which is expected to be released this spring for public comment, indicates a significant switch in how COVID-19 is conceptualized. The guidance would bring COVID-19 into line with how other common respiratory viruses are managed: with isolation recommended until the individual has mild and improving symptoms, and is fever-free (without pharmaceutical aid) for 24 hours.”
    • “With the news of the proposed guidance, many voices rose up to immediately attack the proposed guidance as a capitulation and not evidence-based. This was similar to the refrain from opponents when the federal or state governments dropped or loosened mask requirements or guidance.
    • “I was not one of themopens in a new tab or window.
    • “Indeed, I welcome the proposed guidance change because it reflects the progress that has been made in the management of COVID-19. When evaluating this guidance, it is critical to understand that SARS-CoV-2, the cause of COVID-19, is situated among the myriad respiratory viruses that infect humans.”
  • Medscape lets us know,
    • “Availability of telehealth services for mental healthcare varies widely from state to state, a new study shows. One fifth of all facilities contacted reported no mental telehealth options and wait times for those that did ranged from 4 days to > 2 months, depending on the state.”
  • The National Institutes of Health announced,
    • “To prevent an emerging genomic technology from contributing to health disparities, a scientific team funded by the National Institutes of Health has devised new ways to improve a genetic testing method called a polygenic risk score. Since polygenic risk scores have not been effective for all populations, the researchers recalibrated these genetic tests using ancestrally diverse genomic data. As reported in Nature Medicine, the optimized tests provide a more accurate assessment of disease risk across diverse populations.
    • “Genetic tests look at the small differences between individuals’ genomes, known as genomic variants, and polygenic risk scores are tools for assessing many genomic variants across the genome to determine a person’s risk for disease. As the use of polygenic risk scores grows, one major concern is that the genomic datasets used to calculate the scores often heavily overrepresent people of European ancestry.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “After federal legislation protecting consumers from surprise medical bills was implemented, a growing number of medical claims were in network, according to a new analysis.
    • “The No Surprises Act went into effect on Jan. 1, 2022. From the fourth quarter of 2021 to the first quarter of 2022, in-network care as a percentage of all claim lines nationally increased 2.3%, according to the study by nonprofit Fair Health.
    • “It’s the latest research suggesting No Surprises has been successful in lowering the amount of unexpected out-of-network bills, though the rollout of the law has been tied up in lawsuits, and regulators currently face a backlog of billing disputes between payers and providers.”
  • and
    • “Insurers brace for continued Medicare Advantage medical costs. The big question coming out of the health insurance earnings season is how much elevated utilization among seniors is carrying over into 2024.”
  • EndPoint News points out,
    • “Cigna’s venture unit just made a bet on a startup focused on cardiometabolic conditions that wants to play a role in prescribing GLP-1 medications.
    • “9amHealth said on Tuesday it raised $9.5 million in a Series A extension led by The Cigna Group Ventures. It adds to $16 million from the Series A raised in April 2022 by the startup, which provides virtual visits, prescriptions and lab tests related to conditions like hypertension, type 2 diabetes and weight management.”
    • “Cigna’s investment comes as health plans and pharmacy benefit managers (the PBM Express Scripts is a subsidiary of Cigna) are grappling with how to cover the high cost of GLP-1 medications for conditions like type 2 diabetes and weight loss. It’s among the first investments from an insurance company’s venture arm into a startup prescribing the drugs, which have turned into huge blockbusters and prompted broad conversations about their cost — and benefit — to the healthcare system.”
  • The Wall Street Journal reports,
    • “Pharmaceutical companies are spending billions of dollars to develop drugs that can target cancer like guided missiles.
    • “Therapies known as antibody-drug conjugates, which help deliver chemotherapy directly to tumors, have gotten most of the attention and are farthest along: 
    • “Pfizer’s $43 billion acquisition of biotech Seagen Inc. last year underscored how hot the field has become. 
    • “More quietly, a concept known as radiopharmaceuticals is also gaining ground. In recent months, interest in this space has led to a rise in dealmaking. The idea is similar to ADCs in that a patient receives an old treatment—in this case, a radioactive particle instead of chemotherapy drugs—but it is bound with a molecule that can chase down tumor cells. The technology is at a more nascent stage, but a steady growth of venture capital money and acquisitions by large pharmaceutical companies means this could well become a key part of the fight against cancer in the next decade or so.”
  • HR Dive discusses an EEOC lawsuit against a Georgia retirement community “for firing a 78-year-old receptionist after repeatedly asking her to retire. “The right to decide a retirement age lies with an employee, not their employer,” an EEOC official said.

Friday Factoids

David Ermer–CDC, COVID treatment, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Mental health care, No Surprises Act, Obesity, OPM, U.S. Healthcare–
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.”

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • STAT News reports
    • “Lawmakers are considering increasing doctors’ Medicare pay in an upcoming government funding package, but their policy would only partially offset cuts providers saw earlier this year, three lobbyists and two sources familiar with the talks told STAT.
    • “Physicians’ groups have agitated for Congress to undo a roughly 3.4% Medicare pay cut this year, resulting from the expiration of pandemic-era bonuses lawmakers chose to give the industry.
    • “The cut went into effect on Jan. 1, but a fix hasn’t entirely fallen off of the agenda. A pay increase was discussed in negotiations over a stopgap funding bill earlier this year.
    • “There are more questions than answers at this point in negotiations. It’s unclear what the exact pay increase could be, when it could be passed, and how it could be paid for. The fate of legislation to fund the government is uncertain, too. But the five sources made it clear that an effort to completely offset the 3.4% cut is now off the table.”
  • The New York Times reports,
    • “The Centers for Disease Control and Prevention is considering loosening its recommendations regarding how long people should isolate after testing positive for the coronavirus, another reflection of changing attitudes and norms as the pandemic recedes.
    • “Under the proposed guidelines, Americans would no longer be advised to isolate for five days before returning to work or school. Instead, they might return to their routines if they have been fever free for at least 24 hours without medication, the same standard applied to the influenza and respiratory syncytial viruses.
    • “The proposal would align the C.D.C.’s advice with revised isolation recommendations in Oregon and California. The shift was reported earlier by The Washington Post, but it is still under consideration, according to two people with knowledge of the discussions.
    • “The C.D.C. last changed its policy on isolation in late 2021, when it scaled down the recommended period to five days from 10. If adopted, the new approach would signal that Covid has taken a place alongside other routine respiratory infections.”
  • The Federal Times tells us,
    • “The federal employee retirement backlog shot back up in January, snapping a four-month streak of steadily shrinking caseloads and indicating the government still has trouble getting a handle on its system for processing annuities.
    • “Nearly 13,000 people applied for retirement in January, matching the usual record-high number the Office of Personnel Management receives at the beginning of each calendar year. Traditionally, the retirement claims surge culminates in winter and case workers work through it well into spring.
    • “Last month, the Office of Personnel Management processed roughly 6,400 cases while intaking almost twice that. The overall inventory was 46% higher in January than December. And while processing times again improved last month after steadily quickening, it remains to be seen how the influx will impact speeds in the coming months.
    • “Despite the increases, fewer employees overall retired in 2023 than 2022, 2021 and 2020.”
  • The Society for Human Resource Management lets us know,
    • “Inflation fell in January to 3.1 percent year-over-year, missing some economists’ estimates that it would fall below 3 percent for the first time in nearly three years. 
    • “The Consumer Price Index (CPI) for all items rose 3.1 percent for the 12 months ending in January, before seasonal adjustment, the U.S. Bureau of Labor Statistics (BLS) reported today. That’s down from the unadjusted 3.4 percent annual gain seen in December—and a significant improvement from the 9.1 percent high notched in June 2022. 
    • “Core inflation—which accounts for all items minus food and energy—rose 3.9 percent over the past 12 months, the same for the 12 months ending in December.” 

From the public health and medical research front,

  • The New York Times reports,
    • “Women who develop high blood pressure or diabetes in the course of pregnancy are more likely to give birth to children who develop conditions that may compromise their own heart health at a young age, scientists reported on Monday.
    • “By the time they are 12 years old, these children are more likely to be overweight or to be diagnosed with high blood pressure, high cholesterol or high blood sugar, compared with children whose mothers had complication-free pregnancies.
    • “The research underscores the strong association between healthy pregnancies and child health, though the study stops short of proving a cause-and-effect relationship. The conclusions also offer support for the “fetal origins of adult disease” hypothesis, which suggests that many chronic conditions may have roots in fetal adaptations to the uterine environment.”
  • The American Hospital News points out,
    • “Syphilis infections during pregnancy more than tripled between 2016 and 2022 to 280 cases per 100,000 births, ranging from 46 per 100,000 in Maine to 763 per 100,000 in South Dakota, the Centers for Disease Control and Prevention reported Feb. 13. Rates doubled in seven states and grew fivefold in six states: New Mexico, Colorado, Mississippi, South Dakota, Montana and Alaska. Rates increased across all racial/ethnic and age groups, with the highest rates in mothers who were American Indian and Alaska Native, under age 25 and had no prenatal care.
    • “According to a CDC report last November, over 3,700 mothers passed the infection onto their babies in 2022, 10 times more than in 2012, although timely testing and treatment could prevent most mothers from transmitting the infection to their babies. Congenital syphilis can cause adverse pregnancy outcomes such as fetal and neonatal death, low birthweight, preterm birth, and brain and nerve disorders.”
  • The Wall Street Journal notes,
    • “At a biomedical center here, there’s a man scarfing down Frosted Flakes and tater tots while hooked up to an IV. His job? To help the government figure out what you should eat.
    • “That man, Kevin Elizabeth, a 28-year-old tech worker, is one of 500 Americans who will be living at scientific facilities around the country for six weeks, eating precisely selected meals and undergoing hundreds of medical tests. He is part of a new study, costing $189 million, that is one of the most ambitious nutrition research projects the National Institutes of Health has ever undertaken. * * *
    • “If all goes according to plan, in a few years you’ll be able to walk into your doctor’s office, get a few simple medical tests, answer questions about your health and lifestyle, and receive personalized diet advice, says Holly Nicastro, coordinator for the NIH’s Nutrition for Precision Health study.”
  • On the flip side, MedPage Today explains,
    • “Gastric bypass surgery in people with severe obesity was associated with sustained improvements in cognitive function, inflammation, and comorbidities, according to results of a cohort study in the Netherlands.
    • “At 2 years post-surgery, neuropsychological tests showed improvements of 20% or higher in global cognition (43% of patients), ability to shift attention (40%), episodic memory (32%), verbal fluency (24%), and working memory (11%), reported Amanda J. Kiliaan, PhD, of Radboud University Medical Center in Nijmegen, the Netherlands, and colleagues.
    • “Lower inflammation and adipokine secretion, remission of comorbidities, higher physical activity, and better mood” may have played a role in the sustained improvement in global cognition for that subset of patients, the researchers suggested in JAMA Network Open.”
  • The Washington Post illuminates “How D.C.’s first sobering center could ease drug and alcohol addiction. The facility, part of the District’s response to a worsening opioid epidemic, exceeded 1,000 admissions in just over three months since it opened late last year.”

From the U.S. healthcare business front,

  • Per a Cigna press release,
    • “Cigna Healthcare, the health benefits division of The Cigna Group (NYSE: CI), and HelloFresh*, the world’s leading meal kit company, announce an exclusive collaboration to offer discounted access to HelloFresh’s wholesome, affordable meals to as many as 12 million Cigna Healthcare customers through their employers. The two companies will also team up to support HelloFresh’s Meals with Meaning program, a social impact initiative that provides free meal kits for individuals experiencing food insecurity in local communities.
    • “Business leaders recognize that healthy employees mean a healthy business, and by expanding access to affordable, healthy meals, employers can better cultivate a stronger workforce,” said Heather Dlugolenski, U.S. commercial strategy officer, Cigna Healthcare. “We’re proud to team up with HelloFresh to support the health and vitality of America’s workforce and to make a difference for communities in need.”
  • Per Fierce Healthcare,
    • Chronic care provider Omada Health is expanding its GLP-1 program to better care for patients interested in maintaining weight loss progress while discontinuing usage of the drugs.
    • For patients prescribed to GLP-1 drugs for weight loss, up to 40% of the weight loss can be due to loss of muscle mass. Omada is building upon its weight management solution to help users regain muscle throughout a member’s journey and when the drug is no longer utilized, a solution that would improve health outcomes and allow patients to not stray far from weight-related goals. Members of Omada’s cardiometabolic programs can benefit from the expanded care track, the company said.
  • and
    • “Zocdoc has launched a new guided search to help patients choose and book the right provider with greater confidence. 
    • “The guided search function on the healthcare marketplace and appointment booking platform offers a more tailored set of results based on patients’ unique care needs. When a patient searches for a provider, they are presented with an optional questionnaire to help better understand their symptoms and the type of treatment being sought. The goal is to take the guesswork out of which provider is the best fit.
    • “This search function can also help patients discover more about a provider’s scope of practice and helps providers ensure the patient is a good fit, Zocdoc said. A broad spectrum of specialties have the function available.”
  • Beckers Hospital Review notes,
    • CVS’ Aetna will begin offering in-home care services to its Medicare Advantage members with chronic kidney disease. 
    • Aetna has partnered with Monogram Health, a provider of in-home care management services, according to a Feb. 13 LinkedIn post from Monogram. Under the partnership, Monogram nurse practitioners will provide in-home and virtual specialty provider appointments to eligible Aetna members. 

Happy Lincoln’s Birthday!

David Ermer–CDC, Congress, FDA, Generative AI, Medical / Rx research, SDOH, U.S. Healthcare–

Our greatest President, Abraham Lincoln, was born on February 12, 1809, in Hodgenville, Kentucky.  RIP.

From Washington, DC,

  • The Federal Times reports,
    • “By the second week in February lawmakers are supposed to be busy picking apart the White House’ budget request with an eye towards policy debates in coming months. But the process hasn’t worked that way in recent years.
    • “Administration officials earlier this month announced their fiscal 2025 budget proposal would arrive more than a month late — on March 11 — marking the fourth consecutive year that Biden has missed the statutory deadline for a spending plan in early February.”
  • Federal News Network explains,
    • “For decades, Federal Executive Boards have been at the forefront of bridging together the nationwide federal workforce. Stretching from Honolulu, Hawaii, to Boston, Massachusetts — Seattle, Washington, to South Florida, and many places in between, FEBs have a large network already underway. Even so, recent changes to the decades-old program will refresh how FEBs function moving forward.
    • “Federal News Network has spent months connecting with FEB leaders all across the country to learn more about what they do, the impact they have had in their local areas, and their plans in store for the future. Over the next week, we’ll be focusing on four different regions of the country — one per day:
    • “Eastern Region (Feb. 12) | Southern Region (Feb. 13) | Central Region (Feb. 14) | Western Region (Feb. 15).”
    • Check it out.
  • According to this press release,
    • “The U.S. Department of Health and Human Services (HHS), through the Office of the National Coordinator for Health Information Technology (ONC), announced today that two additional organizations—CommonWell Health Alliance and Kno2—have been designated as Qualified Health Information Networks™ (QHINs™) capable of nationwide health data exchange governed by the Trusted Exchange Framework and Common AgreementSM (TEFCASM). ONC has led a multi-year, public-private process alongside its Recognized Coordinating Entity®, The Sequoia Project, Inc., to implement TEFCA, which was envisioned by the 21st Century Cures Act to support nationwide interoperability. TEFCA became operational in December 2023 with the designation of the first five QHINs—eHealth Exchange, Epic Nexus, Health Gorilla, KONZA, and MedAllies.
    • “CommonWell Health Alliance and Kno2 can immediately begin supporting the exchange of data under the Common Agreement’s policies and technical requirements along with the other designated QHINs. QHINs are the pillars of TEFCA network-to-network exchange, providing shared services and governance to securely route queries, responses, and messages across networks for health care stakeholders including patients, providers, hospitals, health systems, payers, and public health agencies.”
  • STAT News reports,
    • “A federal district judge [in Austin, Texas] on Monday granted the Biden administration’s request to dismiss a lawsuit challenging Medicare’s new drug price negotiation program from the drug industry lobbying organization PhRMA. * * *
    • “However this [decision] wasn’t about the substance of those groups’ arguments. The Texas judge dismissed one of the co-plaintiffs, the National Infusion Center Association, from the case because it didn’t have subject matter jurisdiction to bring the lawsuit. And because NICA was the only party to the lawsuit in Texas, the whole case got tossed.
    • “That means the Biden administration still has to brace for battles in Washington D.C., New Jersey, and Delaware, where a judge recently heard arguments in an AstraZeneca suit against the negotiation plan.”

From the public health and medical research front,

  • MedPage Today points out,
    • “Blood protein profiles predicted future dementia in healthy adults, a large longitudinal study showed.
    • “Blood samples from over 50,000 people in the U.K. Biobank showed that four proteins — glial fibrillary acidic protein (GFAP), neurofilament light (NfL), growth differentiation factor-15 (GDF-15), and latent-transforming growth factor beta-binding protein 2 (LTBP2) — consistently were associated with subsequent all-cause dementia, Alzheimer’s disease, or vascular dementia over 14 years, according to Jin-Tai Yu, MD, PhD, of Fudan University in Shanghai, and co-authors.”
  • The Hill reports,
    • A report from the Centers for Disease Control and Prevention (CDC) found that the rate of preterm births rose by 12 percent nationally between 2014 and 2022. 
    • Manisha Gandhi, chair of the American College of Obstetricians and Gynecologists Clinical Practice Guidelines Committee, told The Hill’s Alejandra O’Connell-Domenech that several factors could be at play. 
    • “We are seeing more patients with obesity, higher risks for hypertension or preeclampsia … seeing more diabetes,” Gandhi said. “Potentially some of those risk factors that lead to earlier delivery could be playing a role.” 
    • Environmental factors such as exposure to hormone-disrupting chemicals and air pollution may also be contributing to the rise in preterm births. 
  • The Wall Street Journal lets us know,
    • “Uterine is the only cancer for which survival has fallen in the past four decades, the American Cancer Society said. The disease will kill some 13,250 women in the U.S. this year, the group estimates, surpassing ovarian cancer to become the deadliest gynecologic cancer. 
    • “Case rates have been increasing by about 1% annually over the past decade, with steeper rises for Black and Hispanic women. Rising obesity rates are partly to blame because excess weight increases estrogen levels that can fuel the cancer, researchers said. And fewer women are getting their uteruses removed to treat abnormal bleeding or noncancerous fibroids, leaving them exposed to the risk cancer develops in the organ as they age.
    • “But those factors alone don’t explain the rise. The disease, more common after menopause, is rising across age groups including in women under 50 for reasons that aren’t completely clear. * * *
    • “Uterine cancer, also called endometrial cancer, comes in two forms. The more common one is slow-growing, linked to elevated estrogen levels, and curable when caught early. The rarer type isn’t hormonal and is harder to treat. Cases of this more aggressive kind are increasing faster and driving rising death rates. 
    • “Chemical hair straighteners have been linked to uterine cancer risk. The Food and Drug Administration plans in July to propose a ban on formaldehyde in hair straightening or smoothing products. 
    • “I don’t think it’s just hair products, sadly,” said Dr. Premal Thaker, a gynecologic surgeon at Siteman Cancer Center in St. Louis. “There’s more diabetes, more obesity, and there’s probably something else that we just don’t know.” 
  • Per Fierce Healthcare,
    • “An “overwhelming” 88% of respondents reporting healthcare discrimination in a new screening initiative were Black, according to a new Humana study.
    • “The report focused on the structural determinants of health as opposed to the more common social determinants of health. While such social determinants center on the conditions in which people live, work, play, learn and worship, structural determinants focus on the economic and social experiences and policies that influence health such as discrimination and health literacy. Both social and structural determinants are often interrelated, according to the study authors. 
    • “The study, published in the American Journal of Managed Care, is the first of its kind by a U.S. insurer to focus on the structural determinants of health, aspects which are “critical” but often overlooked, Humana said.
    • “The healthcare discrimination finding was somewhat problematic given a small sample size and how exactly to frame and ask questions but was nevertheless quite instructive, said co-author J. Nwando Olayiwola, M.D., chief health equity officer and senior vice president at Humana.” 
  • According to an NIH press release,
    • “Scientists have identified an area within the brain’s frontal cortex that may coordinate an animal’s response to potentially traumatic situations. Understanding where and how neural circuits involving the frontal cortex regulate such functions, and how such circuits could malfunction, may provide insight about their role in trauma-related and stress-related psychiatric disorders in people. The study, led by scientists at the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a part of the National Institutes of Health, was published in Nature.
    • “Experiencing traumatic events is often at the root of trauma-related and stress-related psychiatric conditions, including alcohol use disorder (AUD),” said the study’s senior author, Andrew Holmes, Ph.D., senior investigator in NIAAA’s Laboratory of Behavioral and Genomic Neuroscience. “Additionally, witnessing others experience traumatic events can also contribute to these disorders.”
  • MedPage Today explains how patients are using artificial intelligence tools.
    • “It’s no secret that patients have been using Dr. Google for years. The introduction of ChatGPT is ushering in a new era. ChatGPT and other types of artificial intelligence have their drawbacks. Still, they can offer a range of benefits to healthcare providers and patients alike.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Kaiser Permanente wrapped up its fiscal year with $329 million of operating income (0.3% operating income), net income of $4.1 billion and more than $100 billion in both operating revenues and expenses, the Oakland, California-based nonprofit announced Feb. 9.
    • “The rebound performance follows sizable losses during 2022, when the system logged a $1.3 billion operating loss (-1.3% operating income) off of $95.4 billion in operating revenues and $96.7 billion in operating expenses. It had also weathered a net loss of $4.5 billion due to a $3.2 billion loss across “other income,” which largely reflected down investments.
    • “I want to thank the people of Kaiser Permanente for their hard work in 2023 to provide members and patients with a positive experience at all touch points while also embracing new ways to drive efficiencies, improve access, and advance health outcomes,” said Chair and CEO Greg A. Adams said in a press release sharing the year’s top-line financial results. “Together, we navigated another challenging year and are on a path to deliver on our mission and bring our distinct brand of value-based care to more people.”
  • Per BioPharma Dive,
    • “Gilead Sciences will acquire CymaBay Therapeutics and the biotechnology company’s liver disease drug in a $4.3 billion deal announced Monday.
    • “The proposed buyout would hand Gilead an experimental medicine for primary biliary cholangitis, or PBC, a chronic condition characterized by the toxic build-up of bile acid in the liver. CymaBay disclosed Monday that the Food and Drug Administration has accepted its application for the drug, called seladelpar, and will decide on approval by mid-August.”
  • Health IT Analytics notes,
    • “The American Health Information Management Association (AHIMA) has launched its AI Resource Hub to provide healthcare and health information (HI) stakeholders with knowledge around the use of non-clinical artificial intelligence (AI) tools.
    • “In response to the rise of AI utilization in healthcare, AHIMA partnered with Alazro Consulting to interview experts in the space and AI implementers representing over 200 hospitals and 1,000 clinics across the United States. These structured interviews were then used to develop AHIMA’s newest white paper, upon which the AI Resource Hub is based.  
    • “One of the white paper’s major findings is that the use of AI in healthcare is growing as organizations turn to the technology to optimize efficiency and workflows. These tools are often deployed to support health information management, clinical care, operations, and revenue cycle management.”
  • Fierce Healthcare identified its Fierce 15 of 2024.
    • “This year’s 15 honorees recognized a significant gap in the market, whether it’s for personalized GI care, opening up access to mental health or addressing loneliness among seniors with a robot companion. They then set to work to build forward-thinking solutions to address a specific problem.
    • “They are all taking a fresh angle to long-standing problems in healthcare, such as harnessing AI to streamline clinical documentation or using virtual care to treat the root causes of obesity.”