Tuesday Tidbits

OPM

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.”

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.”

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.”

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.”

Thursday Miscellany

David Ermer–ACA, CMS, Employee Wellness Programs, Mental health care, OPM, SDOH, U.S. Healthcare, Wellness–

As you may be able to tell, it’s a late FEHBlog post because the FEHBlog was returning home to Dripping Springs, TX, last night from our Nation’s capital.

In case, here are some highlights from Washington DC.

  • The GAO released a troubling report on our country’s fiscal health this week. Here’s a link to a Wall Street Journal Opinion Watch podcast about the report. The podcast is about 20 minutes long, and it may make your hair stand on edge.
  • Mercer Consulting discusses changes to the RxDC reports due annually on June 1.
    • “CMS released instructions for the third prescription drug data collection (RxDC) reports due June 1, 2024 – and they may cause plan sponsors to reconsider whether they need to make “plan level” submissions, instead of relying on their vendors to make “aggregate” submissions on their behalf. The good news is that the instructions largely mirror prior versions, so plan sponsors should be able to build off prior RxDC reporting efforts. However, for the first time, CMS plans to enforce the “aggregation restriction”—a provision in the 2021 regulations that CMS suspended for the first two reporting cycles. As explained [in the article], the reinstated aggregation restriction may cause headaches for some plan sponsors, who find that they can no longer rely on their PBM’s aggregate submission of pharmacy data but must instead submit plan level data. Other plan sponsors may welcome the opportunity to do a plan level submission so they can obtain otherwise unavailable prescription drug data.”
  • Per Govexec,
    • “With federal budget talks still unresolved less than a month away from Congress’ latest deadline, the Office of Personnel Management said Friday that the decade-long pay freeze for senior political appointees like Vice President Kamala Harris and others will remain in effect.
    • “In a Feb. 9 post, OPM Director Kiran Ahuja said that under January’s continuing resolution that extended federal funding to agencies until March 1 and 8, certain senior political appointees will continue to see their payable pay rates remain at current levels at least through the latter budget deadline, when Congress will have to decide whether it will continue to fund the federal government. 
    • “Future Congressional action will determine whether the pay freeze continues beyond March 8, 2024,” Ahuja said. “Until such time, the OPM guidance issued on Dec. 21, 2023, regarding the pay freeze for certain senior political officials continues to be generally applicable in applying the pay freeze in 2024.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “There isn’t a silver bullet to maintaining mental acuity or warding off dementia [as we age], scientists of aging say. But a combination of genetics, healthy lifestyle habits and factors such as cleaner air and good education have been linked to prolonged mental agility.  * * *
    • “Genetics is thought to play a role in brain maintenance, as does diet, exercise and a person’s risk of vascular disease. More education, mental stimulation and social connectivity have been associated with improved cognitive reserve.
    • “Better brain maintenance and cognitive reserve might help keep symptoms of dementia at bay. Almost 50% of people 40 and older think they will likely develop dementia, according to a 2021 AARP survey. The actual number of U.S. adults 65 and older with dementia is closer to 10%, a 2022 study found. * * *
    • “Sleeping too little—or too much—can also lead to cognitive problems. Activities including yoga and tai chi, the Chinese martial art, could help improve cognitive function, research suggests. 
    • “Hearing loss is a risk factor for dementia, too. Lost hearing might cause the brain to atrophy more quickly and can make people more isolated, said Dr. Dung Trinh, chief medical officer of the Healthy Brain Clinic. Hearing aids can help preserve mental fitness.”
  • AHA News adds,
    • “About half of U.S. health care workers have witnessed racial discrimination against patients and say discrimination against patients is a crisis or major problem, according to a survey released Feb. 15 by the Commonwealth Fund and African American Research Collaborative. Younger workers and workers of color were more likely than their older or white counterparts to say they witnessed discrimination, as were workers at facilities with more patients of color. About six in 10 Black health care workers and four in 10 Latino, Asian American and Pacific Islander workers say they have been discriminated against because of their race or ethnicity. 
    • “While most health care workers see positive efforts from employers to address discrimination, a majority of Black, Latino, and AAPI workers worry about retaliation if they raise discrimination concerns. When asked about potential solutions, more than two-thirds of health care workers thought the following could help: providing an easy way to anonymously report situations involving racism or discrimination; creating opportunities to listen to patients and health care professionals of color; examining treatment of non-English-speaking patients; and training health care staff to spot discrimination.” 
  • Employee Benefit News offers three suggestions on how employers can help employees hold cancer at bay with preventive screenings.
    • “A new report from healthcare platform Color Health shows that although 80% of employers are concerned by rising cancer costs and 96% of benefits leaders agree early detection is the best solution, the majority of focus is devoted to post-diagnosis treatment, rather than evidence-based screenings. 
    • “According to the report, three out of four employers say they are placing more emphasis on screening, early detection and risk prevention efforts, but they are going to have to go beyond their current benefits setup: Only a quarter believe their current health plans meet the screening needs of their workforce, and three-quarters say employees are not being adequately screened by their primary care provider. Leaders report that 40% of employees are not compliant with screenings in general, and for the most deadly forms of cancer — lung and bronchus — the American Lung Association reports that only 6% of people eligible get screened. 
    • “The assumption [has been that] if we cover mammograms and colonoscopies and lung CTs, then people will actually get them, and that’s turned out to be false,” says Othman Laraki, Color Health’s CEO. “The big driver for that is that for non-acute care services, availability is not the same thing as access.” 

Midweek Update

David Ermer–Congress, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The American Hospital Association News reports,
    • “The House Energy and Commerce Subcommittee on Health Feb. 14 held a hearing on AHA-supported legislation to reauthorize through 2029 the Dr. Lorna Breen Health Care Provider Protection Act (H.R. 7153), which provides grants to help health care organizations offer behavioral health services for front-line health care workers. The bill also would reauthorize a national campaign that provides hospital leaders with evidence-based solutions to support worker well-being. Without congressional action, the law will expire at the end of this year.  
    • “Among other measures, the hearing highlighted legislation (H.R. 6960) to reauthorize the Emergency Medical Services for Children Program, which provides funding for equipment and training to help hospitals and paramedics treat pediatric emergencies. AHA advocated for funding the program at $28 million for fiscal year 2024.”
  • According to HHS press releases,
    • “On Wednesday, February 14, 2024, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra and leaders from across HHS met with state leaders and representatives from the National Governors Association (NGA) to announce the launch of HHS Secretary’s Postpartum Maternal Health Collaborative. The six states that have agreed to participate in the Postpartum Maternal Health Collaborative are Iowa, Massachusetts, Maryland, Michigan, Minnesota, and New Mexico.
    • “This new collaborative seeks to bring together state experts, local providers, community partners, and federal experts to develop a better understanding of the challenges being experienced among the postpartum population and support new solutions that will improve postpartum mortality. In conjunction with this new HHS collaborative, the National Governors Association launched their Improving Maternal and Child Health in Rural America State and Territory Policy Learning Collaborative. This new initiative will focus on implementing policy changes to improve maternal and child health outcomes in rural America.”
  • and
  • and
  • Meritalk adds,
    • “The Office of Personnel Management (OPM) today released its 2023 Equity Action Plan, which spotlights data as a tool to better understand barriers and advance diversity, equity, inclusion, and accessibility (DEIA) in the Federal workforce.
    • “OPM plans to advance the equitable participation of Federal employees in the Federal Employees Health Benefits (FEHB) Program by conduct a mixed methods study that will access and analyze data to identify barriers and potential solutions to accessing health benefits.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration has approved a new regimen for pancreatic cancer, clearing Ipsen’s Onivyde to be used with chemotherapy in treating recently diagnosed metastatic tumors, the company announced Tuesday.
    • “Onivyde, which Ipsen bought from Merrimack Pharmaceuticals seven years ago, has been available for second-line use in pancreatic cancer, after tumor progression. The new OK will give physicians the option to use it earlier.
    • “The FDA’s decision was based on results from a Phase 3 trial Ipsen ran involving 770 people with metastatic pancreatic cancer. The data showed that Onivyde plus the chemo regimen FOLFOX improved survival and delayed tumor progression for longer than a combination of the drugs Abraxane and gemcitabine.”
  • Beckers Hospital Review informs us,
    • “On Feb. 14, the FDA approved Aurlumyn, the nation’s first treatment for severe frostbite. 
    • “Severe frostbite, which is estimated to affect 1% of the general population, happens when the skin and underlying tissue are frozen and blood flow is stopped. Aurlumyn (iloprost) is an injection that works by opening blood vessels, preventing blood from clotting.
    • “The skin damage from severe frostbite sometimes requires finger and toe amputations. In a trial of 47 patients, a bone scan after one week predicted that zero of the 16 study participants who received iloprost alone would need an amputation, compared to 3 of the 16 who received the drug with another experimental frostbite therapy and 9 of 15 who received another unapproved therapy alone. 
    • “Actelion Pharmaceuticals US received the drug approval.” 
  • STAT News tells us,
    • “An advisory panel to the Food and Drug Administration voted in favor of a new device from Abbott meant to treat patients with tricuspid heart valve disease. All but one of the 14 panelists said the treatment’s benefits outweighed its risks. The FDA tends to follow advisory panel recommendations.
    • “If we can help symptoms with this at a low cost in terms of risk, I think it makes a lot of sense,” said James Blankenship, a panelist and cardiologist at the University of New Mexico. 
    • “The device is called the TriClip, and it addresses a disease called tricuspid regurgitation: a heart condition that causes blood to leak backward through the tricuspid heart valve. The condition impacts 1.6 million people in the United States. Symptoms include fatigue, swelling, and atypical heart rhythms. In severe cases, the condition can lead to heart failure. 
    • “Current treatment options are drugs to reduce extra fluids or correct heart rhythm, or in more serious cases, surgery to correct the valve. Abbott hopes to cater to patients for whom medications are ineffective and surgery is too risky. The device, which clips together the disparate parts of the valve, is delivered via a catheter rather than open heart surgery.” 
  • Per an HHS press release,
    • “Today the Federal Trade Commission (FTC) and the U.S. Department of Health and Human Services (HHS) jointly issued a Request for Information to understand how the practices of two types of pharmaceutical drug middlemen groups—group purchasing organizations (GPOs) and drug wholesalers—may be contributing to generic drug shortages.
    • “In the Request for Information (RFI) – PDF, the FTC and HHS are seeking public comment regarding market concentration among large health care GPOs and drug wholesalers, as well as information detailing their contracting practices. The joint RFI seeks to understand how both GPOs and drug wholesalers impact the overall generic pharmaceutical market, including how both entities may influence the pricing and availability of pharmaceutical drugs. The joint RFI is asking these questions to help uncover the root causes and potential solutions to drug shortages.”
  • Per Govexec,
    • “Last December, lawmakers included a new provision in the 2024 National Defense Authorization Act clarifying that “honorable” active duty military service will count toward the FMLA’s eligibility requirements, and in turn to the federal workforce’s paid parental leave benefit.
    • “In a memo to agency heads Tuesday, OPM Director Kiran Ahuja outlined how federal agencies should implement the tweak. Specifically, federal employees whose military service would put them over a year of federal service should “immediately” become eligible for the two forms of leave, dating back to Dec. 22, 2023, the day President Biden signed the NDAA into law.”

From the public health and medical research front,

  • The National Institutes of Health explains,
    • “Women who receive an mRNA-based COVID-19 vaccination or booster during pregnancy can provide their infants with strong protection against symptomatic COVID-19 infection for at least six months after birth, according to a study from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. These findings, published in Pediatrics(link is external), reinforce the importance of receiving both a COVID-19 vaccine and booster during pregnancy to ensure that infants are born with robust protection that lasts until they are old enough to be vaccinated.
    • “COVID-19 is especially dangerous for newborns and young infants, and even healthy infants are vulnerable to COVID-19 and are at risk for severe disease. No COVID-19 vaccines currently are available for infants under six months old. Earlier results from the Multisite Observational Maternal and Infant COVID-19 Vaccine (MOMIv-Vax) study revealed that when pregnant volunteers received both doses of an mRNA COVID-19 vaccine, antibodies induced by the vaccine could be found in their newborns’ cord blood. This suggested that the infants likely had some protection against COVID-19 when they were still too young to receive a vaccine. However, researchers at the NIAID-funded Infectious Diseases Clinical Research Consortium (IDCRC), which conducted the study, did not know how long these antibody levels would last or how well the infants would actually be protected. The research team hoped to gather this information by following the infants through their first six months of life.”
  • STAT News lets us know,
    • “Public health messages have told us for decades that if you smoke, you should quit. And if you don’t smoke, don’t start. But a new study suggests smoking may be even worse than we thought.
    • “The study, published Wednesday in Nature, underscores the importance of never lighting up that first cigarette, based on its conclusion that smoking has much longer harmful effects on immune responses than previously understood.
    • “People who quit smoking soon regained normal function of their immune system’s power to mount fast and general innate responses to bacteria or viruses. But researchers also found that slower, more targeted adaptive T cell defenses remembered from past pathogens did not come back so soon after that last cigarette.
    • “We could see that the effect of active smoking on inflammatory responses to bacterial stimulation were lost when individuals quit smoking,” senior study author Darragh Duffy of the Institut Pasteur said about the innate response on a call with reporters. “In contrast, the effect on the T cell response was maintained for many years after the individuals quit smoking.”
  • STAT News further reports
    • “The HPV vaccine is a success story in some countries, including the U.K., where it beat estimates of how long it would take to nearly eliminate cervical cancer, the disease it is designed to prevent, among young women. And that was more than two years ago. Last month, a study in Scotland found no cases of cervical cancer in women who were vaccinated before age 14. In the U.S., it’s still a work in progress. A CDC report out today tells us that 39% of children age 9 to 17 had received at least one dose of the HPV vaccine, with rates rising with age from 7% in the youngest kids  to 57% in the oldest. Some differences in who got vaccinated:
      • “By insurance: Private health insurance (42%), Medicaid (37%), other government coverage (30%), and no insurance (21%).
      • “By neighborhood: Large central metropolitan areas (4o%), large fringe metropolitan areas (41%), and medium and small metropolitan areas (39%), and nonmetropolitan areas (30%).” 

From the U.S. healthcare business front,

  • Fierce Healthcare points out,
    • “Elevance Health’s $2.5 billion acquisition of Blue Cross and Blue Shield of Louisiana is on pause yet again amid concerns about the impact on competition.
    • “BCBSLA posted a statement on its website Wednesday, saying that while the insurer wants to find a “strong partner” that can support it into the future, the team has also heard the skepticism in the Pelican State.
    • “We continue to hear from our stakeholders that they want Blue Cross and Blue Shield of Louisiana to remain their trusted partner in their healthcare journey, and we pursued this transaction to help us do exactly that — by changing for the better,” the insurer said. “However, it is clear that our stakeholders need more time and information to understand the benefits of the changes we have proposed.”
    • “This is why we have decided to again pause the process in our proposed transaction with Elevance Health,” BCBSLA said.”
  • BioPharma Dive notes,
    • “Sage Therapeutics said its new medicine, the first oral treatment for postpartum depression, is off to an encouraging start, with signs of demand from prescribing doctors.
    • “Sage and partner Biogen began selling the drug, Zurzuvae, in mid-December and on Wednesday Sage shared the first data from an estimated 10 days when doctors’ offices were open at the end of the month. During that time, physicians wrote about 120 prescriptions for the drug and 50 prescriptions were shipped and delivered to patients.”

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. 

Friday Factoids

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, OPM, U.S. Healthcare–

From Washington, DC

  • The U.S. Office of Personnel Management released its call letter for benefit and rate proposals for 2025 FEHB and Postal Service Health Benefit (PSHB) plans. Not surprisingly, the 2025 call letter focuses on the launch of the PSHB Program on January 1, 2025. The next step will be for OPM to issue its technical guidance. The benefit and rate proposals are due on May 31, 2024.
  • Fierce Healthcare reports,
    • “A bipartisan group of senators announced Friday that it is working on new legislation for “long-term reforms” to physician payments under Medicare and other program changes.
    • “In a joint release, U.S. Sens. Catherine Cortez Masto, D-Nevada; Marsha Blackburn, R-Tennessee; John Barrasso, R-Wyoming; Debbie Stabenow, D-Michigan; Mark Warner, D-Virginia; and Minority Whip John Thune, R-South Dakota said they have formed a “Medicare payment reform working group.”
    • “The lawmakers plan to proposes changes to the physician fee schedule and “make necessary updates” to 2015’s Medicare Access and CHIP Reauthorization Act (MACRA), they said, and “in the coming weeks” will be seeking feedback from stakeholders.”
  • The Department of Health and Human Services announced,
    • “On Thursday, February 8, 2024, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra addressed the National Press Club in Washington, D.C. for its historic Headliners Luncheon.
    • “During his address, he urged the nation to shift from an “illness-care system” to a “wellness-care system.” He also highlighted the Biden-Harris Administration’s work to increase access to quality, affordable health care, lower health care costs, including the cost of prescription drugs, and protect access to reproductive health care.”

From the public health and medical research front,

  • The Centers for Disease Control tells us,
    • What CDC knows
      • BA.2.87.1, a new variant of SARS-CoV-2, the virus that causes COVID-19, was identified in South Africa by the National Institute for Communicable Diseases. CDC is closely tracking this variant because of the large number of mutations when compared to previous variants. At this time, BA.2.87.1 has not been identified in clinical specimens outside South Africa. Because this is a newly emerging variant, there is not as much additional data about its potential impact. So far, the public health risk for this new variant appears low.
    • What CDC is doing
      • CDC continues to track the appearance and spread of new variants around the world through genomic surveillance. CDC is working closely with partners in South Africa to gather the latest information on BA.2.87.1. CDC and its partners are continually assessing potential impacts to vaccines, tests, and treatments.
    • Keep reading: CDC Tracks New SARS-CoV-2 Variant, BA.2.87.1
  • Here is a link to the CDC’s Covid Data Tracker.
  • ABC News adds,
    • “The flu virus is hanging on in the U.S., intensifying in some areas of the country after weeks of an apparent national decline. 
    • “Centers for Disease Control and Prevention data released Friday showed a continued national drop in flu hospitalizations, but other indicators were up — including the number of states with high or very high levels for respiratory illnesses.
    • ““Nationally, we can say we’ve peaked, but on a regional level it varies,” said the CDC’s Alicia Budd. “A couple of regions haven’t peaked yet.”
  • MedPage Today lets us know,
    • “The CDC has published its first comprehensive laboratory recommendations for syphilis testing.
    • “Published in the Morbidity and Mortality Weekly Reportopens in a new tab or window, the new recommendations include approaches for laboratory-based tests, point-of-care tests, sample processing, and how laboratories should report test results to clinicians and health departments.
    • “The recommendations are primarily for clinical laboratory or disease control personnel, but also for clinicians to understand how to collect and process specimens, interpret test results, and counsel and treat patients, according to CDC researchers led by John Papp, PhD, of the agency’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention in Atlanta.”
  • Mercer Consulting suggests that rising cancer rates call for a comprehensive strategy.
    • “A comprehensive cancer strategy includes both support for employees as they cope with the physical and emotional stresses of a cancer diagnosis, and effective care management to help ensure the patient receives quality care quickly in the most appropriate setting — which can lead to better outcomes and better use of healthcare dollars. Just over a third of large employers (34%) provide a specialized cancer care management program. These programs assist with care coordination, support compliance with treatment regimens, find applicable clinical trials, and connect families to local community resources and to other solutions the employer offers.  
    • “Centers of Excellence or site-of-care navigation programs, offered by 24% of large employers, help ensure that members are treated by quality providers with relevant experience and expertise. Hotlines, caregiver and family advocacy services, and financial planning services can help employees and their families deal with the day-to-day challenges of the cancer journey.”
  • Milliman Consulting offers some use cases for AI in healthcare and their implications for health insurers.
  • Per BioPharma Dive,
    • Takeda Pharmaceutical plans to quickly begin late-stage testing of an experimental drug for narcolepsy, which, if successful, could help the company enter what Wall Street analysts see as a multibillion-dollar market.
    • There are two kinds of narcolepsy, with a key difference being that “Type 1” can involve a sudden loss of muscle control. Takeda has been testing its drug, known as TAK-861, as a potential treatment for both, and on Friday disclosed high-level results from a pair of studies that each focused on one type.
    • “Takeda said the Type 1 trial, which evaluated 112 patients, found those given its drug as opposed to a placebo experienced statistically significant and “clinically meaningful” improvements in wakefulness at the eight-week mark. The company now intends to begin Phase 3 trials in the first half of its fiscal year, which begins April 1.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Primary care providers Indianapolis-based Marathon Health and Denver-based Everside Health completed their merger on Thursday, and will operate as Marathon Health.
    • “The Marathon executive team — CEO Jeff Wells and executive chairman Ben Evans — will stay intact post-merger, while Everside Health CEO Chris Miller will depart the company, according to a company spokesperson. Marathon declined to disclose financial details of the deal.
    • “The new Marathon Health will have a physical presence in 41 states at 680 health centers and provide virtual healthcare in all 50 states.” 
  • and
    • “One Medical is closing several offices and moving its chief financial officer to a role focused on growth as Amazon attempts to reallocate internal resources to cut costs.
    • “One Medical plans to close offices in New York City, Minneapolis and St. Petersburg, Florida, by the end of February, according to an internal email obtained by Business Insider. The company will also downsize its San Francisco office space to one floor.
    • “An Amazon spokesperson confirmed the changes to Healthcare Dive and said the company is reducing its investment in corporate office space given many One Medical corporate employees work remotely.”
  • MedTech Dive informs us,
    • “Fresenius Medical Care has received 510(k) clearance for its high-volume hemodiafiltration dialysis therapy system, the company said Thursday.
    • “The device, the 5008X Hemodialysis System, uses both diffusion and convection to remove waste products from the blood of kidney disease patients. Using diffusion, the standard mechanism for hemodialysis, and convection is intended to improve the removal of larger waste products.
    • “Fresenius plans to start a broad market launch next year and push to establish hemodiafiltration, which is already widely used in Europe, as the new standard of care in the U.S.”
  • Health Payer Intelligence points out “KLAS Report Reveals Top-Performing Vendors for Payer Services. The top-performing vendors varied across payer services, with Zelis ranking high for payment accuracy and integrity and ZeOmega succeeding in care management.”

Thursday Miscellany

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

From Washington, DC

  • Think Advisor lets us know,
    • “The U.S. House of Representatives voted 211-208 on Wednesday to pass H.R. 485, the Protecting Health Care for All Patients Act of 2023.
    • “The bill would prohibit federal health programs — including Medicare, Medicaid and the Federal Employees Health Benefits Program — from using a “quality-adjusted life year” measure or similar measures when allocating resources.
    • “All Republicans who voted supported the bill, and all Democrats who voted opposed it.
    • “The bill was introduced by Rep. Cathy McMorris Rodgers, R-Ore.”
  • Roll Call reports,
    • “House Energy and Commerce Chair Cathy McMorris Rodgers, a 10-term Republican from Washington state who has been a strong advocate for people with disabilities, announced Thursday she would not seek reelection this year.
    • “It’s been the honor and privilege of my life to represent the people of Eastern Washington in Congress. They inspire me every day,’’ Rodgers said in a statement. “After much prayer and reflection, I’ve decided the time has come to serve them in new ways. I will not be running for re-election to the People’s House.”
    • “The announcement comes as Rodgers is leading negotiations with the Senate on a wide-ranging health care package that touches all parts of the industry. The legislation would implement more transparency in data and pricing for prescription drugs and other medical services.”
  • BioPharma Dive informs us,
    • “The CEOs of three major drugmakers defended the prices they charge U.S. patients in a Senate [Health Education Labor and Pensions] committee hearing Thursday, claiming Americans gain access to cutting-edge medicines months or years earlier than people in countries that pay a fraction of the U.S. costs. * * *
    • “Sen. Ben Ray Luján, D-N.M., asked the CEOs to pledge to not block entry of generics or biosimilars to the respective drugs in the spotlight when their primary patents expire, which Merck and Bristol Myers agreed to. That question in the case of Bristol Myers Squibb was focused Opdivo, its cancer immunotherapy rival to Keytruda.
    • “For Merck, Davis committed to open competition with any forthcoming biosimilars of intravenous Keytruda. But he didn’t mention the company is trying to develop and launch a subcutaneous, or under-the-skin, version that would likely extend its market advantage beyond the anticipated 2028 expiration of its main patent. Bristol Myers is also working on subcutaneous Opdivo.
    • “Questioned by Luján on settlements that have pushed the launch of biosimilar Stelara to 2025, J&J’s Duato said the price of the drug will be lower when that happens and added that prices net of rebates have dropped ahead of biosimilar competition.”
  • Bloomberg reports,
    • “The pharmaceutical industry, Trump and Obama administration officials, and others are urging the Biden administration to reconsider a controversial plan for seizing patents on a drug when its cost gets too high, claiming the approach misinterprets decades-old law and threatens the delicate pipeline that produces innovative, life-saving drugs.
    • “Over 500 comments were filed by the Feb. 6 deadline for groups and individuals to weigh in on the Biden administration’s framework for the federal government to use its march-in rights. The proposal lays out the Biden administration’s stance in a longstanding debate over whether price is a justifiable reason for the government to “march in” and take over a patent on technology developed with the help of taxpayer dollars and then license it to an outside manufacturer.
    • “The Biden plan is already drawing blowback from a broad swath of players in the innovation space. A collection of former US Patent and Trademark Office directors and other government officials under the George W. Bush, Obama, and Trump administrations wrote to warn that the proposed framework, if adopted, would prove destabilizing.”
  • Per an HHS press release
    • “The Department of Health and Human Services’ Office of Intergovernmental and External Affairs (IEA) will be hosting a stakeholder webinar TOMORROW, February 9, 2024, from 2 – 3 PM ET to provide an update on patient privacy.  
    • “Today, the U.S. Department of Health and Human Services, through its Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), finalized modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR part 2 (“Part 2”), which protect the privacy of patients’ SUD treatment records. Specifically, today’s final rule increases coordination among providers treating patients for SUDs, strengthens confidentiality protections through civil enforcement, and enhances integration of behavioral health information with other medical records to improve patient health outcomes.
    • “Today’s rule was informed by the bipartisan Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that, among other things, required HHS to bring the Part 2 program into closer alignment with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Breach Notification, and Enforcement Rules.
    • “The final rule includes the following modifications to Part 2:
      • “Permits use and disclosure of Part 2 records based on a single patient consent given once for all future uses and disclosures for treatment, payment, and health care operations.
      • “Permits redisclosure of Part 2 records by HIPAA covered entities and business associates in accordance with the HIPAA Privacy Rule, with certain exceptions.
      • “Provides new rights for patients under Part 2 to obtain an accounting of disclosures and to request restrictions on certain disclosures, as also granted by the HIPAA Privacy Rule.
      • “Expands prohibitions on the use and disclosure of Part 2 records in civil, criminal, administrative, and legislative proceedings.
      • “Provides HHS enforcement authority, including the potential imposition of civil money penalties for violations of Part 2.
      • “Outlines new breach notification requirements applying to Part 2 records.”
    • “A fact sheet on the final rule may be found at: https://www.hhs.gov/hipaa/for-professionals/regulatory-initiatives/fact-sheet-42-cfr-part-2-final-rule/index.html“
    • Register in advance for this webinar: REGISTER HERE  
  • Govexec tells us,
    • “The U.S. Postal Service was $2 billion in the red in the first three months of fiscal 2024—typically its busiest and most profitable period of the year—doubling its loss from the same period in the previous year. 
    • “The accelerated losses during the holiday season continue a longstanding trend of poor financial performance for the mailing agency, but mark a troubling sign as its leadership team undertakes significant operational transformations with a promise to right the ship.
    • “In a positive development, however, USPS turned a net profit of $472 million when accounting only for the part of the ledger postal management deems within its control. That figure, which does not include fluctuations in workers’ compensation and amortized payments toward employee retirement accounts, grew from $187 million in the first quarter of the prior year.” 
  • The U.S. Office of Personnel Management announced,
    • “[t]he Finalists for this year’s Presidential Management Fellows (PMF) Program, the federal government’s premier leadership development program. In total, 825 Finalists were selected from more than 7,000 applicants from around the world. 
    • “Presidential Management Fellows are the next generation of federal government leaders,” said Kiran Ahuja, Director of OPM. “The PMF Program gives Fellows the leadership skills and exposure they need to make a difference in government and an impact within their community. Congratulations to all the 2024 PMF finalists. We cannot wait to see what you will accomplish in public service.” 

From the public health and medical research front,

  • Medscape points out,
    • “Brain fog is one of the most common, persistent complaints in patients with long COVID. It affects as many as 46% of patients who also deal with other cognitive concerns like memory loss and difficulty concentrating. 
    • “Now, researchers believe they know why. A new study has found that these symptoms may be the result of a viral-borne brain injury that may cause cognitive and mental health issues that persist for years.
    • “Researchers found that 351 patients hospitalized with severe COVID-19 had evidence of a long-term brain injury a year after contracting the SARS-CoV-2 virus. The findings were based on a series of cognitive tests, self-reported symptoms, brain scans, and biomarkers.” 
  • STAT News reports,
    • “People receiving a double dose of naloxone are no more likely to survive an opioid overdose than people receiving a standard, 4-milligram nasal spray, according to a new study.
    • “The new paper, published Thursday in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report, showed no significant difference in survival rates between people who were revived using 4- and 8-milligram sprays of naloxone, commonly known by the brand name Narcan. People receiving the smaller dose also did not require a higher total number of sprays, despite having received just half the initial amount. The researchers found only one major contrast between those receiving different dose sizes: Those who received a double dose were over 2.5 times more likely to experience severe withdrawal symptoms, like vomiting.
    • “The study comes as pharmaceutical companies continue to market expensive high-dose formulations of naloxone, arguing that amid record drug death levels resulting from potent synthetic opioids like fentanyl, it’s essential to deliver as much of the overdose-reversal medication as possible. Public health experts and harm-reduction groups have pushed back, however, charging that the companies have used Americans’ fear of fentanyl as an excuse to sell needlessly expensive naloxone products to cash-strapped public health agencies.”
  • Beckers Hospital Review reports,
    • “Patients who take Ozempic, Mounjaro and Wegovy are less likely to be diagnosed with anxiety or depression compared to those who don’t receive the popular diabetes and weight loss drugs, according to a new study. 
    • “A review of more than 4 million patient records conducted by Epic Research found that diabetic patients are less likely to have anxiety if they are taking any glucagon-like peptide-1 receptor agonist. 
    • “The researchers analyzed five different GLP-1s: tirzepatide (Mounjaro, Zepbound), semaglutide (Ozempic, Wegovy, Rybelsus), dulaglutide (Trulicity), liraglutide (Saxenda, Victoza) and exenatide (Byetta, Bydureon). 
    • “The patients taking GLP-1s for weight loss were compared with those receiving another kind of weight loss drug, and diabetic patients were compared with people not taking a GLP-1.”
  • The American Hospital Association News notes how you can “[l’earn how hospitals and health systems are improving maternal and child health outcomes in this synopsis of the latest resources from AHA’s Better Health for Mothers and Babies initiative. READ MORE.”
  • The NIH Director discusses in her blog “What’s Behind that Morning Migraine? Community-Based Study Points to Differences in Perceived Sleep Quality, Energy on the Previous Day.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • AstraZeneca sees its revenue and core earnings per share growing by double-digit percentages in 2024, the pharmaceuticals major said as it reported fourth-quarter core earnings per share below expectations on higher costs, sending the stock lower.
  • CNBC discusses how “Novo Nordisk, Eli Lilly are tackling weight loss drug supply woes.”
    • “Last week, the Danish drugmaker [Novo Nordisk] said it had more than doubled its supply of lower-dose versions of its weight loss injection Wegovy in January compared to previous months. Supply shortages forced Novo Nordisk to restrict the availability of those lower doses in the U.S. since May. 
    • “But why are those lower doses important? It’s because people are supposed to start Wegovy at a low dose and gradually increase the size over time to mitigate side effects such as nausea. So, more of those low “starter” doses means more new patients can begin treatment with Wegovy. 
    • “The company plans to “gradually” increase the overall supply of Wegovy throughout the rest of the year, executives added on the company’s fourth-quarter earnings call Wednesday.”
  • Per Healthcare Dive,
    • “UnitedHealth’s chief operating officer Dirk McMahon is retiring after more than two decades at the company.
    • “McMahon plans to retire on April 1, the payer said in a Wednesday filing with the Securities and Exchange Commission on Wednesday.
    • “UnitedHealth has yet to name a replacement for McMahon.”
  • and
    • “Walgreens has named a new head of its healthcare unit as the pharmacy chain works to improve its halting finances and shift to delivering more healthcare services.
    • “John Driscoll, the current executive vice president and president of the U.S. Healthcare segment, will be replaced by Mary Langowski, who previously held the chief executive role at chronic condition management company Solera Health. Driscoll will serve in a senior advisory role, Walgreens announced Thursday.”
  • and
    • “Molina Healthcare lost half a million Medicaid members due to redeterminations by the end of 2023, executives said Thursday.
    • “States resumed checking beneficiaries’ eligibility for the safety-net program in April following a pause during the COVID-19 public health emergency. Some 16 million Americans have been disenrolled from Medicaid to date because of the redeterminations. The process is disproportionately impacting insurers with a heavy Medicaid presence like Molina, which brings in 80% of its revenue from the program.
    • “Molina still expects to retain 40% of its Medicaid membership once redeterminations are complete. However, on Thursday the insurer raised its estimate of members gained during COVID from 800,000 to 1 million because of new business adds. That implies a net member loss of 600,000 once redeterminations are complete.” 
  • and
    • “Tenet Healthcare beat Wall Street expectations for revenue in the fourth quarter of 2023 on continued cost control measures and sustained demand for services, particularly in its ambulatory care unit, executives said during an earnings call on Thursday.
    • “CEO Saum Sutaria told investors that Tenet was entering a “new era” in which a higher proportion of its performance was generated by its ambulatory surgical business. Same-facility revenue for ambulatory services grew 9.2% during 2023, above Tenet’s long-term goal of 4% to 6% top line growth.
    • “The Dallas-based for-profit will continue a careful watch on its debt levels, executives said. The company has recently taken steps to reduce its leverage, last week finalizing the sale of three hospitals to Novant Health and announcing the sale of four additional hospitals to UCI Health.”
  • Beckers Payer Issues discusses why it appears that insurers are split in two camps over rising Medicare Advantage costs.

Midweek update

David Ermer–CDC, CMS, COVID-19, Generative AI, Medicare, NIH, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The Department of Health and Human Services informs us,
    • “On Monday, February 5, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra met virtually with pharmacy CEOs, including Walgreens, CVS, Walmart, and pharmacy leaders, to discuss COVID-19 therapeutics commercialization. Secretary Becerra reconvened pharmacy leaders as a follow-up to his larger meeting with pharmacies, pharmacy benefit managers, and insurers on January 9, 2024.
    • “During the call, Secretary Becerra made it clear that no patient should be charged hundreds of dollars for Paxlovid at the pharmacy counter – stressing the importance of pharmacist education and clear communication to patients. Secretary Becerra re-iterated the Biden-Harris Administration’s commitment to equitable access to COVID-19 therapeutics, reminded pharmacy leaders of the pathways for access that HHS negotiated with Pfizer, and made it clear that HHS would continue to engage with pharmacist leadership as needed.
    • “While HHS is no longer managing the distribution of COVID-19 therapeutics since they transitioned to the commercial market, the Biden-Harris Administration has been closely monitoring the therapeutics commercialization process and remains committed to equitable access to lifesaving COVID-19 therapeutics, including Paxlovid. Thanks to the pathwaysthat HHS negotiated with Pfizer, all individuals on Medicare and Medicaid can receive Paxlovid for free through 2024 and individuals who are uninsured can receive Paxlovid for free through 2028. * * *
    • “To learn more about Paxlovid access, go to Pfizer’s PAXCESS Website“
  • Health Payer Intelligence points out a KFF study on how various types of payer cover COVID-19 tests, treatments and vaccines post-public health emergency.
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services yesterday released FAQs clarifying coverage criteria and utilization management requirements for Medicare Advantage plans under its final rule for calendar year 2024, which includes provisions intended to increase program oversight and create better alignment between MA and Traditional Medicare. Topics addressed by the FAQs include medical necessity determinations; algorithms and artificial intelligence; internal coverage criteria; post-acute care; the two-midnight benchmark for inpatient admission criteria; prior authorization; and enforcement.”
  • STAT News adds,
    • “In recent months, the federal government has repeatedly told Medicare Advantage insurers that they cannot use artificial intelligence or algorithms to deny medical services the government routinely covers.
    • “But in finalizing a rule to that effect, it also stepped into a thicket of questions from insurers about a technology that is especially difficult to pin down: What is AI? Can it be used at all to make decisions about the coverage of older patients? If so, how?
    • “This week, the federal agency that oversees Medicare sought to boil it all down into a simple directive: Put the circumstances of the individual patient first, and your algorithm second.
    • “An algorithm that determines coverage based on a larger data set instead of the individual patient’s medical history, the physician’s recommendations, or clinical notes would not be compliant” with federal regulations, the government wrote in a memo to Medicare Advantage insurers on Tuesday.”
  • Health plans were using algorithms in claims processing long before AI exploded on the scene. On a related note, Health IT Analytics explores the benefits of predictive analytics in healthcare.
  • The FEHBlog noticed this entry on the OMB Office of Information and Regulatory Affairs website.
AGENCY: OPMRIN: 3206-AO43Status: Pending ReviewRequest EO Meeting
TITLE: Postal Service Reform Act; Establishment of the Postal Service Health Benefits Program 
STAGE: Final RuleSECTION 3(f)(1) SIGNIFICANT: No
** RECEIVED DATE: 02/06/2024LEGAL DEADLINE: None  
From Reginfo.gov
  • This notice pertains to OPM’s effort to finalize the interim final rule establishing the Postal Service Health Benefits Program issued April 6, 2023. OIRA review is the last step in the regulatory process before publication of this “final, final” rule in the Federal Register. OPM had project publishing that rule this month.
  • Drug Channels discusses
    • the latest National Health Expenditure (NHE) data, which measures all U.S. spending on healthcare.
    • As you will see, retail and mail prescription drug spending remain a consistently small share of the $4.5 trillion that we spend on U.S. healthcare. 
    • And contrary to what you might read, drug spending growth was *not* driven by purportedly “skyrocketing” drug prices. In reality, nearly all drug spending growth occurred due to growth in the number of people treated, prescriptions dispensed, and other nonprice factors.

From the public health and medical research,

  • The Washington Post offers an opinion piece by former CDC Director Thomas Frieden about the public health importance of treating hypertension.
  • The Post also provides background on stomach cancer, the disease that cause country singer Toby’s Keith’s death earlier this week.
  • The National Institutes of Health announced,
    • In a recent study of the brain’s waste drainage system, researchers from Washington University in St. Louis, collaborating with investigators at the National Institute of Neurological Disorders and Stroke (NINDS), a part of the National Institute of Health (NIH), discovered a direct connection between the brain and its tough protective covering, the dura mater. These links may allow waste fluid to leave the brain while also exposing the brain to immune cells and other signals coming from the dura. This challenges the conventional wisdom which has suggested that the brain is cut off from its surroundings by a series of protective barriers, keeping it safe from dangerous chemicals and toxins lurking in the environment.
    • “Waste fluid moves from the brain into the body much like how sewage leaves our homes,” said NINDS’s Daniel S. Reich, M.D., Ph.D. “In this study, we asked the question of what happens once the ‘drain pipes’ leave the ‘house’—in this case, the brain—and connect up with the city sewer system within the body.” Reich’s group worked jointly with the lab of Jonathan Kipnis, Ph.D., a professor at Washington University in St. Louis. * * *
    • Together, the labs found a “cuff” of cells that surround blood vessels as they pass through the arachnoid space. These areas, which they called arachnoid cuff exit (ACE) points, appear to act as areas where fluid, molecules, and even some cells can pass from the brain into the dura and vice versa, without allowing complete mixing of the two fluids. In some disorders like Alzheimer’s disease, impaired waste clearance can cause disease-causing proteins to build up. Continuing the sewer analogy, Kipnis explained the possible connection to ACE points:  
    • “If your sink is clogged, you can remove water from the sink or fix the faucet, but ultimately you need to fix the drain,” he said. “In the brain, clogs at ACE points may prevent waste from leaving. If we can find a way to clean these clogs, its possible we can protect the brain.”  
  • Medscape lets us know,
    • “Dry January has come to an end — at least for those who jumped on the trendy post-holiday no-booze wagon.
    • “The benefits of drinking less alcohol are well documented. A systematic review of 63 studies, for example, found that reducing or giving up alcohol reduced people’s risk for hospitalization, injuries, and death. The lifestyle change also improved people’s physical and mental health as well as their quality of life.
    • “When it comes to cancer risk, however, the benefits of quitting or cutting back on alcohol remain much less clear, according to a new report from the cancer agency of the World Health Organization (WHO).
    • “After reviewing dozens of studies, the International Agency for Research on Cancer (IARC) concluded that, for most alcohol-related cancers, there is limited evidence to support a link between eliminating or reducing alcohol consumption and lowering of cancer risk.”

From the U.S. healthcare business front,

  • Healthcare Dive relates,
    • “Citing elevated medical costs, CVS Health on Wednesday cut its 2024 outlook despite posting better revenue and earnings than Wall Street had expected in the fourth quarter.
    • “The massive healthcare conglomerate now expects to bring in at least $8.30 in adjusted earnings per share this year, compared to prior guidance of $8.50.
    • “CVS is the latest insurer to post 2024 guidance below investors’ expectations, after Humana released a disappointing earnings outlook last month.”
  • and
    • “Amazon is cutting hundreds of jobs across One Medical and Amazon Pharmacy, the company confirmed on Wednesday.
    • “The goal of the cuts is to “realign” resources to meet the divisions’ goals, Amazon Health Services SVP Neil Lindsay said in an email to staff shared with Healthcare Dive. The company is not disclosing the number of employees or what roles are being impacted by the cuts.
    • “Affected employees will receive financial support and benefit continuation, as well as the opportunity to apply for new roles at Amazon, according to Lindsay. Amazon is not on a hiring freeze and will continue to hire providers and employees for One Medical and Amazon Pharmacy.”
  • Beckers Hospital Review notes,
    • “More than a quarter of the top U.S. hospitals for patient experience fall under Providence’s umbrella, according to a new ranking from PEP Health. 
    • “The Minneapolis-based AI platform extracts behavioral insights data from patient comments shared on multiple social media and review platforms. To rank the top U.S. hospitals for patient experience in 2024, PEP Health gathered and analyzed more than 30 million online patient reviews shared between Jan. 1 and Dec. 31, 2023.  * * *
    • “On average, the top 30 scored 30% higher in continuity of care, 22% higher in attention to physical and environmental needs, and 17% higher in fast access than their peers. 
    • “Hospitals belonging to Renton, Wash.-based Providence excelled on more than half of the assessment metrics, according to PEP’s report. Although eight of the top 30 hospitals were prefixed with “Providence” — and another, Swedish Medical Center-First Hill in Seattle, is an affiliate — the system could still show improvement in communication and emotional support, per the AI company.”
  • Per BioPharma Dive,
    • “Amgen is a global pharmaceutical company worth more than $160 billion. Nine of its marketed medicines are blockbuster products by annual sales.
    • “Yet, on a Tuesday conference call discussing Amgen’s fourth quarter earnings, all Wall Street analysts wanted to talk about was an experimental drug that only just cleared the first stage of human testing.
    • “More than half of the questions asked by analysts were focused on AMG 133, a promising treatment for obesity that’s drawn attention as a potential competitor to in-demand weight loss medicines from Novo Nordisk and Eli Lilly. While Wall Street often overlooks the present to focus on the future, the intense interest in a drug years away from the market was noteworthy.”
  • Milliman has made available its
    • “sixth annual Milliman Multiemployer Health and Welfare Study, which analyzes financial disclosures for multiemployer health and welfare plans, also known as Taft-Hartley plans. This year’s report includes data for 1,226 plans covering approximately 4.6 million members as of 2021, the most recent year for which data is available. The average plan could pay about one year and three months of benefits and expenses with its net assets, a decrease of approximately one month from 2020.”