Weekend Update

NIH

Weekend Update

David Ermer–CDC, Congress, COVID-19, Medicare, NIH, U.S. Healthcare–

From Washington, DC,

  • Last Thursday, June 13, the House Appropriations Committee met to consider “Fiscal Year 2025 Financial Services and General Government Appropriations Act.” The measure was approved by the Committee with a vote of 33 to 24. The Committee adopted an amendment that “Requires the Office of Personnel Management (OPM) to submit a report on the coverage options currently available to federal employees that include assisted reproductive technology services and procedures.” 
  • Healthcare Dive tells us,
    • “Members of Congress are questioning the CMS Innovation Center’s progress in moving the nation’s health system to value-based care after a report found the center has increased federal spending instead of lowering it.”
    • “The Center for Medicare and Medicaid Innovation, or CMMI, was created by the Affordable Care Act more than a decade ago. The center is tasked with testing new healthcare payment and delivery models to lower costs and improve quality in government health programs.
    • “However, during at House Energy and Commerce subcommittee hearing on Thursday, some lawmakers — particularly Republicans — stressed that CMMI has failed to save money during its first 10 years and could continue to increase spending over the next decade. * * *
    • “Some legislators raised concerns about a lack of provider input into CMMI models. But a new strategic direction for CMMI, announced in 2021, should improve transparency and lay out the center’s priorities, Fowler said.
    • “Many stakeholders, including healthcare providers and various industry stakeholders, have expressed concern about the complexity, administrative burden and perceived lack of transparency involved when participating in the CMMI models,” said Rep. Bob Latta, R-Ohio.”
  • The American Medical Association lets us know,
    • “Just months after Congress again failed to stop in its entirety a pay cut that threatens Medicare patients’ access to high-quality physician care, the AMA House of Delegates made crystal clear the imperative to step up the pressure on the nation’s lawmakers and boost patient awareness about the dire need for Medicare payment reform.
    • “In a federal budget deal struck to continue operating the government, Congress in March reduced to less than 2% the 3.37% across-the-board physician pay cut that took effect in January.
    • “The House of Delegates (HOD) directed the AMA to:
      • “Increase media awareness around the 2024 AMA Annual Meeting about the need for Medicare payment reform, eliminating budget-neutrality reductions, and instituting annual cost-of-living increases.
      • ‘Step up its public relations campaign to get more buy-in from the general public about the need for Medicare payment reform.
      • “Increase awareness to all physicians about the efforts of our AMA on Medicare payment reform.
      • “Advocate for abolition of all Merit-based Incentive Payment System (MIPS) penalties in light of the current inadequacies of Medicare payments.
    • “This direction from the HOD bolsters the AMA’s aggressive efforts in leading the charge to reform the Medicare payment system.

From the public health and medical research front,

  • The Hill takes a look at the CDC’s current Covid statistics. Here’s the sentence that grabbed the FEHBlog’s attention: “[H]ospitalizations for COVID-19 remain very low nationwide. Only 0.6% of all emergency department visits were diagnosed as COVID cases last week.
  • A Buffalo, NY, television station WGRZ offers tips on how to reduce the risk of falling as you age, which is useful information for FEHB plans to share given the FEHB’s older demographics.
  • The National Institutes of Health announced today,
    • A data-driven intervention that engaged communities to rapidly deploy evidence-based practices to reduce opioid-related overdose deaths – such as increasing naloxone distribution and enhancing access to medication for opioid use disorder – did not result in a statistically significant reduction in opioid-related overdose death rates during the evaluation period, according to results(link is external) from the National Institutes of Health’s HEALing (Helping to End Addiction Long-Term) Communities Study. Researchers identified the COVID-19 pandemic and increased prevalence of fentanyl in the illicit drug market – including in mixtures with cocaine and methamphetamine – as factors that likely weakened the impact of the intervention on reducing opioid-related overdose deaths.
    • The findings were published in the New England Journal of Medicine and presented at the College on Problems of Drug Dependence (CPDD) meeting on Sunday, June 16, 2024. Launched in 2019, the HEALing Communities Study is the largest addiction prevention and treatment implementation study ever conducted and took place in 67 communities in Kentucky, Massachusetts, New York, and Ohio – four states that have been hard hit by the opioid crisis.
  • STAT News promptly followed up with an article about this NIH announcement.
    • “In statements, federal health officials cast the study as at least a partial victory. While the interventions did not meaningfully reduce overdose deaths, the officials argued, they set the stage for future action and created a framework to help hard-hit communities choose new policy approaches and begin to implement them, with the hope that with more time and without Covid-19, deaths would fall.  “In statements, federal health officials cast the study as at least a partial victory. While the interventions did not meaningfully reduce overdose deaths, the officials argued, they set the stage for future action and created a framework to help hard-hit communities choose new policy approaches and begin to implement them, with the hope that with more time and without Covid-19, deaths would fall.  
    • “[Nora] Volkow, the NIDA director, said that increasing use of stimulants like methamphetamine and cocaine, and the proliferation of fentanyl, mean society must “continue developing new tools and approaches” for preventing overdose deaths. Miriam Delphin-Rittmon, the administrator of the Substance Abuse and Mental Health Services Administration, said the study “recognizes there is no quick fix.” 
    • “And in an interview, [Redonna] Chandler, the director of the study, stressed that the results should not challenge what research has long demonstrated: There is a “mountain of evidence,” she said, supporting the belief that tools like naloxone, medications for opioid use disorder, and safer prescribing techniques, save lives. The challenge, Chandler said, lies in implementation — not the strategies themselves. 
    • “The study released Sunday, she said, “doesn’t negate, in any way, the evidence that suggests the strengths of those interventions.”

Thursday Miscellany

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

From Washington DC,

  • Federal News Network lets us know,
    • “For federal employees, a bill pending in the Senate would bring expanded coverage of fertility treatments through the Federal Employees Health Benefits (FEHB) program.
    • “But the Right to IVF Act, which Sens. Tammy Duckworth (D-Ill.), Patty Murray (D-Wash.) and Cory Booker (D-N.J.) introduced last week, did not garner the 60 votes needed to move forward with a floor vote Thursday afternoon. Almost all Republicans voted against the measure to advance the legislation, resulting in a 48-47 tally.
    • “The legislation rolls together three previous bills all aiming to improve access and insurance coverage for in-vitro fertilization (IVF). In part, the bill would have impacts specifically on FEHB enrollees. One component of the Right to IVF Act aims to set higher requirements for FEHB carriers to offer IVF coverage.
    • “The Office of Personnel Management increased FEHB carrier requirements for IVF treatments for plan year 2024. But the legislation looks to further extend the requirements of IVF to cover both treatments and medications, as well as expanding to more types of assisted reproductive technology (ART).”
  • Many large FEHB plans cover ART procedures. Competition will cause other plans to follow their lead.
  • Federal News Network also identifies House of Representatives policy riders to FY 2025 appropriations bills that are relevant to federal employees and their benefit programs.
  • The American Hospital Association News relates,
    • “The House Energy and Commerce Health Subcommittee June 13 held a hearing about transitioning to value-based care. The AHA submitted a statement to the subcommittee for the hearing, expressing support for value-based care and sharing principles the Center for Medicare and Medicaid Innovation should consider when designing alternative payment models. Those principles include adequate on-ramp and glidepath to transition to risk; adequate risk adjustment; voluntary participation and flexible design; balanced risk versus reward; guardrails to ensure participants don’t compete against themselves when they achieve optimal cost savings and outcomes; and upfront investment incentives.” 
  • Healthcare Dive informs us,
    • “The Supreme Court on Thursday unanimously ruled an anti-abortion group contesting the Food and Drug Administration’s approval of the abortion pill mifepristone does not have a legal basis to sue, putting an end to a drawn-out and high-profile court battle.
    • “The court held the plaintiffs’ “desire to make a drug less available to others” did not give them standing to challenge the FDA’s actions around mifepristone.
    • “The plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact,” Justice Brett Kavanaugh wrote in the court’s opinion. “For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.”
  • The Wall Street Journal adds,
    • “An appeals panel [in August 2023] rolled back much of the [district court’s] ruling, saying it was too late to challenge the drug’s original approval. But the appeals court did find that the plaintiffs had standing to sue, and it ruled the FDA’s efforts beginning in 2016 to make the pill more available were unlawful. The Supreme Court had previously put that ruling on hold, preserving the status quo of widespread mifepristone access while it considered the case. * * *
    • “The pill case won’t be the last time the justices weigh in on abortion access this term. The court in the next couple of weeks is expected to decide a separate case out of Idaho that centers around the question of whether a federal law that requires hospitals to provide stabilizing care for patients at risk of death or serious injury trumps state abortion bans that allow doctors to perform the procedure only if a woman’s life is in jeopardy.”
  • STAT News notes,
    • “Both President Biden and former President Trump love to claim credit for getting more Americans $35 insulin.
    • “But the credit should actually go to a giant pharmaceutical company — just the type that both men claim to have challenged.
    • “Eli Lilly, an $800 billion pharma giant and one of three insulin manufacturers in the United States, first proposed an experiment allowing Medicare insurance plans to offer $35 monthly insulin in 2019, CEO David Ricks and former Medicare agency chief Seema Verma said in interviews with STAT.
    • “It is true. We approached CMS with that idea,” Ricks said, referring to the government Medicare agency.
    • “Verma gave Ricks credit. “He is an unsung hero. He was actually the mastermind of all of this,” she said.”
  • Per Department of Health and Human Services press releases,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), awarded more than $11 million to 15 organizations to establish new residency programs in rural communities. HHS Secretary Xavier Becerra and White House Domestic Policy Advisor Neera Tanden announced the new awards while visiting rural health clinic in Wisconsin Rapids, Wisconsin today. Building on HRSA’s Enhancing Maternal Health Initiative, one program will create the first obstetrics and gynecology Rural Track Program in the country, and six others will develop new family medicine residency programs with enhanced obstetrical training in rural communities.”
    • “For more information about the Rural Residency Planning and Development Program, visit https://www.hrsa.gov/rural-health/grants/rural-health-research-policy/rrpd.”
  • and
    • “The Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), is announcing up to $500 million in Project NextGen funding to plan and execute multiple Phase 2b clinical trials evaluating novel vaccines administered as a nasal spray or as a pill to protect against symptomatic COVID-19.
    • “We learned a lot during the COVID-19 pandemic that we can use to better prepare for future public health crises. That includes finding new ways to administer vaccines to make it even easier for everyone to protect themselves from illness,” said HHS Secretary Xavier Becerra. “We are making progress on the development of cutting-edge treatments, such as vaccines administered as a nasal spray or as a pill. The Biden-Harris Administration won’t stop until we have the next generation of innovative vaccines, therapeutics, and other tools to protect against COVID-19, or any other pathogen that could threaten the American public.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Avoid raw milk. Lay off cheeses made with unpasteurized milk. And cook your beef to medium- or well-done temperatures.
    • “These are the precautions that public health officials and doctors recommend as they track the H5N1 bird flu outbreak in U.S. cattle. Ten states have H5N1 outbreaks in cows, according to the Centers for Disease Control and Prevention, and at least three U.S. dairy farmworkers have been diagnosed with bird flu. 
    • “A man in Mexico contracted a different strain of bird flu—H5N2—earlier this month and died, though he died from underlying conditions, according to the Mexican government.
    • “Doctors and federal officials say the public health risk of getting H5N1 is currently very low unless you work on a farm, and stress that there has been no evidence of human-to-human transmission. What’s raised concern is that the most recent case—found in a dairy worker in Michigan earlier this month—had respiratory symptoms unlike the previous two cases where the primary symptom was pinkeye. 
    • “Viruses with respiratory symptoms are more contagious and transmissible than conjunctivitis, or pinkeye, so doctors and scientists say they are watching closely. For now, it has been more than a week since the worker tested positive and there have been no known cases of transmission.”  
  • The NIH director in her weekly blog tells us,
    • We know stress can take a toll on our mental health. Yet, it’s unclear why some people develop stress-related mental health disorders and others don’t. The risk for developing a stress-related mental health disorder such as post-traumatic stress disorder (PTSD) or major depressive disorder (MDD) depends on a complex interplay between the genetic vulnerabilities we are born with and the impact of traumatic stress we experience over our lifetimes.
    • Given this complexity, it’s been difficult for researchers to pinpoint the underlying biological pathways in the body that ultimately produce changes associated with PTSD, major depression, or other mental health conditions. Now, a study reported in a special issue of Science on decoding the brain uses a comprehensive approach to examine multiple biological processes across brain regions, cell types, and blood to elucidate this complexity. It’s an unprecedented effort to understand in a more holistic way the essential biological networks involved in PTSD and MDD. * * *
    • “There’s clearly much more to discover in the years ahead. But these insights already point to important roles for known stress-related pathways in fundamental brain changes underlying PTSD and MDD, while also revealing more novel pathways as potentially promising new treatment targets. With further study, the researchers hope these findings can also begin to answer vexing questions, such as why some people develop PTSD or major depression after stressful events and others don’t.”
  • STAT News points out that “With placenta-on-a-chip, researchers hope to gauge how drugs and toxins impact pregnancy.”
    • “[Mechanical engineer Nicole] Hashemi and her colleagues received a three-year, $350,000 grant from the National Science Foundation to advance their current placenta-on-a-chip model. They plan on designing systems that can be integrated into the model to help collect data in real time. Hashemi told STAT that one system could look at changes in the shapes of cells when exposed to chemicals or physical stressors.
    • “The placenta-on-a-chip technology is simple but potentially powerful, and similar efforts are being made to replicate the environments of other human organs. The small chip is usually about the size of a rubber eraser, etched with tiny channels through which fluids move — offering a simplified, functional model of an organ to test drugs or to study the progression of disease. Researchers can grow cells and run fluids that act like blood through chambers in the chip to create environments similar to those in the human body.
    • “According to Dan Huh, a professor of bioengineering at the University of Pennsylvania and a leader in developing many organs-on-a-chip including the placenta and lung, maintaining the environment is almost like tricking the cells into thinking that they’re still in the body so that they “do what they’re supposed to do.”
  • MedPage Today tells us,
    • “Disrupted access to prescription stimulants for patients with attention deficit-hyperactivity disorder (ADHD) may increase risks of injury or overdose, the CDC warned on Thursday following the indictment of an online ADHD medication prescriber over fraud allegations.
    • “Several ADHD stimulants such as immediate-release amphetamine (Adderall) are already in shortage, and the new federal healthcare fraud indictment may further disrupt care for as many as 50,000 patients with ADHD, the CDC detailed.
  • The Journal of the American Medical Association released a research letter about trends in Naloxone dispensing from U.S. retail pharmacies.
    • “Naloxone prescriptions dispensed from retail pharmacies increased from 2019 to 2023, with the largest single-year increase observed in 2022. This increase may reflect efforts to expand naloxone prescribing, including state-level standing orders3 and clinical practice guidelines. Although statistically significant increases were observed among most prescriber specialties between 2019 and 2023, nearly two-thirds of dispensed naloxone was prescribed by advanced practitioners and primary care specialties in 2023. Continued efforts such as evidence-based academic detailing and electronic health record alerts can support clinicians in prescribing naloxone.
    • “The observed decrease in retail pharmacy–dispensed naloxone prescriptions during Q3 and Q4 2023 may be due to naloxone becoming available over the counter,4 though trend analysis indicated the decline was not statistically significant. Studies have found that over-the-counter naloxone has a higher out-of-pocket cost than insurance-paid naloxone prescriptions,5 indicating the continued importance of prescribed naloxone and naloxone accessed in community-based settings. * * *
    • “Although naloxone dispensing has increased in recent years, opportunities remain to expand access given the continued high burden of opioid overdoses,1 such as by increasing co-prescribing of naloxone for patients with high-risk opioid prescriptions2,6 and reducing financial barriers.5“

From the U.S. healthcare business front,

  • The Wall Street Journal reports good news for Medicare Advantage insurers,
    • “The federal government plans to redo this year’s quality ratings of private Medicare plans, according to people familiar with the matter, a move that would deliver hundreds of millions in additional bonus payments to insurers next year.
    • “The decision by the Centers for Medicare and Medicaid Services could be announced as soon as Thursday. It comes in the wake of two court rulings that faulted the agency’s ratings, in cases filed by insurers SCAN Health Plan and Elevance Health.
    • “By paving the way for higher payments, the CMS move would provide a win for Medicare insurers at a time when their business is under pressure from rising healthcare costs and rates for next year that came in lower than investors had expected.'”
  • Mercer Consulting explores “Unlocking the power of [healthcare] price transparency data.”
  • MedTech Dive informs us,
    • “Philips has launched its Duo Venous Stent System in the U.S. to treat patients with blockages in their veins, the company said Wednesday.
    • “The implant, which won approval in December, is designed to address the root cause of chronic deep venous disease and comes in two forms for use in different types of veins. 
    • “Philips acquired the device in its 2022 takeover of Vesper Medical. The company paid 227 million euros upfront for Vesper to expand its image guided therapy business.”
  • and
    • “Medline has asked hospitals to remove thousands of endotracheal tubes because of a risk that components can tear or detach, blocking a patient’s airway. 
    • “The company recalled more than 168,000 Medline Sub-G Endotracheal Tubes and more than 13,000 kits, according to a Food and Drug Administration notice posted on May 28. The tubes are used for mechanical ventilation and have ports to prevent fluid from draining into patients’ lungs and causing pneumonia. 
    • “Medline recalled the products because the inflation tube and other components can detach or tear from the main tube, causing it to leak or deflate. If the device comes apart during use, it could also obstruct the patient’s airway or cause choking, the FDA said in a Tuesday notice.
  • and
    • “Abbott is recalling a system monitor used with the Heartmate cardiac pump because screen display issues could pose a risk to patients. The Class 1 recall affects 4,842 monitors distributed in the U.S. and worldwide, according to a June 7 database entry by the Food and Drug Administration.
    • “In an urgent medical device correction letter to physicians in May, Abbott said no serious adverse health consequences were reported and no devices are being removed from the market.
    • “The latest recall follows three others from earlier this year involving the Heartmate left ventricular assist system, the only such mechanical circulatory support device on the U.S. market after Medtronic stopped selling its Heartware pump in 2021.”

Midweek Update

David Ermer–ACA, Congress, Medical / Rx research, Medicare, NIH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Congress.gov tells us that the House Appropriations Committee’s markup of the Financial Services and General Government appropriations bill, which funds OPM and FEHB, has been postponed to June 13 at 11 am ET.
  • Modern Healthcare reports,
    • “National health expenditures rose 4.1% to $4.5 trillion in 2022, according to data the Centers for Medicare and Medicaid Services Office of the Actuary published in the journal Health Affairs Wednesday.
    • “Healthcare accounted for 17.3% of gross domestic product last year, down from 18.2% in 2021. The independent, nonpartisan CMS analysts previously projected healthcare spending would rise to $7.17 trillion, or 19.6% of gross domestic product, by 2031.
    • “Expenditures and their rate of change have stabilized since the worst phases of the COVID-19 pandemic in 2020 and 2021 caused spending to spike and healthcare as a share of GDP to increase, the actuaries’ report showed.”
  • Axios lets us know,
    • “Almost two years after the debut of a revamped national suicide hotline, its promise of a quicker, more seamless crisis response across the country is still a work in progress.
    • “Why it matters: Congress gave states $1 billion to build out the 988 hotline, amid nationwide concern over worsening mental health, with the expectation that states would establish their own own long-term funding to operate call centers and crisis services.”
    • “But those efforts have been uneven, contributing to significantly lower response times in certain states. As with much of the health care system, the level of crisis services available to people depends greatly on where they live.
    • “What they’re saying: “We want a system where everybody has a comparable experience. It seems to me we’re still a few years from that,” said Chuck Ingoglia, CEO of the National Council for Mental Wellbeing.
    • “He and other advocates and experts Axios spoke with said 988 implementation has been improving.”
  • Per the Department of Health and Human Services,
    • “Over the past decade, syphilis rates and case numbers in the U.S. have increased across all populations. In response to this surge in syphilis cases, HHS formed the National Syphilis and Congenital Syphilis Syndemic Federal Task Force led by HHS Assistant Secretary for Health Admiral Rachel Levine.
    • “Today, this task force issued new considerations for health care providers who test patients for syphilis. The new HHS document “Considerations for the Implementation of Point of Care Tests for Syphilis – PDF,” outlines four main differences between syphilis point of care tests and laboratory-based serologic syphilis tests and highlights the best settings to consider use of point-of-care tests. It also examines parameters for point of care testing program implementation and management, provides answers to common questions, and lists links to related resources.
    • “Syphilis testing is crucial, as syphilis infections can be difficult to diagnose because many of those infected may not have symptoms,” said Admiral Rachel L. Levine, MD, Assistant Secretary for Health. “The Food and Drug Administration has authorized two point-of-care tests for syphilis that can provide rapid test results during the same visit in about 15 minutes. This can help overcome barriers in our ability to timely diagnose patients in communities across the nation.”
  • Here’s a link to a new Health Affairs Forefront article on the Biden Administration’s ACA Section 1557 final rule.

From the public health and medical research front,

  • The New York Times reports,
    • “A new study linking the low-calorie sugar substitute xylitol to an increased risk of heart attack or stroke has once again raised questions about the risks and benefits of sugar substitutes.
    • “Xylitol is a sugar alcohol found naturally in fruits and vegetables, and even produced in the human body at very low levels. But it is often synthetically produced and is increasingly being added to processed foods, like candies and “low-sugar” baked goods, because it has 40 percent fewer calories than regular sugar does and doesn’t cause blood glucose to spike after a meal. The study authors said this rise in consumption was concerning, as the people most likely to turn to the sugar substitute may already be trying to manage conditions like obesity and diabetes that also increase the risk of cardiovascular issues.
    • “They may think they’re making a healthy choice by picking xylitol over sugar, yet the data argues that it is not the case.” said Dr. Stanley Hazen, the chair of cardiovascular and metabolic sciences at the Cleveland Clinic’s Lerner Research Institute and an author of the study. Last year, Dr. Hazen and his colleagues found a similar association with another sugar alcohol, called erythritol.”
  • Per the National Institutes of Health,
    • “Researchers have identified inherited genetic variants that may predict the loss of one copy of a woman’s two X chromosomes as she ages, a phenomenon known as mosaic loss of chromosome X, or mLOX. These genetic variants may play a role in promoting abnormal blood cells (that have only a single copy of chromosome X) to multiply, which may lead to several health conditions, including cancer. The study, co-led by researchers at the National Institutes of Health’s (NIH) National Cancer Institute, was published June 12, 2024, in Nature. * * *
    • “The scientists suggest that future research should focus on how mLOX interacts with other types of genetic variation and age-related changes to potentially alter disease risk.”
  • Following up on a FEHBlog post from last week, Beckers Hospital Review points out,
    • “The National Academies of Sciences, Engineering, and Medicine has proposed a more precise definition of long COVID-19.
    • “In its latest report, the group said long COVID needs to be understood as “an infection-associated chronic condition that occurs after COVID-19 infection and is present for at least three months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems.” 
    • “This comes after the National Academies published research detailing more than 200 symptoms related to long COVID. 
    • “Our committee hopes this single definition, crafted with input from across research and patient communities, will help to educate the public about this widespread and highly consequential disease state,” Harvey Fineberg, MD, PhD, chair of the report’s authoring committee and president of the Gordon and Betty Moore Foundation, said in a June 11 news release.
    • “The new definition also says long COVID:
      • “Can involve any organ system and present with a range of symptoms.
      • “Can come after asymptomatic, mild, or severe SARS-CoV-2 infections.
      • “Can affect children and adults.
      • “Can be clinically diagnosed even without a biomarker.
      • “Can exacerbate preexisting conditions or present new ones.
      • “Can be delayed in onset for weeks or months following acute infection.
      • “Can resolve over a period of months or take years to resolve fully.”

From the U.S. healthcare business front,

  • MedCity News tells us,
    • “In 2021, Medicare Advantage beneficiaries spent about $2,541 less in out-of-pocket costs and premiums than beneficiaries with fee-for-service Medicare, a new report discovered.
    • “The report, released Monday, was conducted by healthcare research firm ATI Advisory and commissioned by Better Medicare Alliance, a research and lobby group for Medicare Advantage (MA). To conduct the study, the researchers used the 2019 to 2021 Medicare Current Beneficiary Survey and Cost Supplement files. The results of the study show an increase from last year’s report, which found that MA beneficiaries spent about $2,400 less than traditional Medicare on average in 2020.
    • “The researchers also found reduced spending among Medicare Advantage beneficiaries across racial and ethnic groups in 2021. Black MA beneficiaries paid $1,617 less in out-of-pocket costs and premiums than those in traditional Medicare, while Latino MA beneficiaries paid $1,593 less and White MA beneficiaries paid $2,371 less. In 2021, 25% of MA beneficiaries were Black or Latino, compared to 14% of traditional Medicare enrollees.”
  • Healthcare Dive lets us know,
    • “The Federal Trade Commission’s case aiming to block Novant Health from acquiring two Community Health Systems-owned North Carolina hospitals was dealt a series of blows this week. On Tuesday, U.S. District Court Judge Kenneth Bell ruled to deny the antitrust agency’s latest preliminary injunction against the deal. * * *
    • “Bell ruled last week the sale could go forward as planned, reasoning that the hospitals were likely to shutter entirely absent a sale, which could harm care access in the region. The judge further argued that the deal could have a net positive impact on competition in the region by allowing Novant to better compete with the area’s largest healthcare provider, Atrium Health.
    • “The FTC intends to fight that ruling in the 4th U.S. Circuit Court of Appeals. The antitrust agency filed its notice of appeal on Sunday, and petitioned a district court on Monday to pause the transaction during the appellate review.
    • “However, Bell denied the FTC’s latest request for a preliminary injunction, again citing the risk of hospital closures.”
  • Here’s a link to a law firm’s updated list of important takeaways for employees about the Pregnant Workers Fairness Act which took effect last June.

Thursday Miscellany

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

From Washington, DC

  • Following up on the House Appropriations subcommittee’s approval of the Financial Services and General Government bill yesterday, Fedweek notes,
    • “By taking no position on a raise, the measure effectively endorses President Biden’s proposal for a 2 percent increase in January. That would follow the practice of most recent years of allowing the recommendation to take effect by default, and would result in the smallest raise since the 1 percent paid in January 2021. The measure however does continue longstanding language tying raises for wage grade employees to those of GS employees in an area, even though the two pay systems operate under separate locality-based rules.”
  • The Washington Post reports “Biden wants hospitals to report data on gunshot wounds.”
    • “The Biden administration is enlisting America’s doctors to help combat gun violence.
    • “About 160 health-care executives and officials have been invited to the White House today and Friday to promote public health solutions to the epidemic. A top priority, I’m told: The White House wants hospital emergency departments to collect more data about gunshot injuries their physicians treat, as well as routinely counsel patients about the safe use of firearms.”
  • Healthcare Dive informs us,
    • “A federal judge ruled Wednesday Novant Health can move forward with its plans to purchase two North Carolina hospitals from Community Health Systems, despite a request from the Federal Trade Commission to stall the deal.”A federal judge ruled Wednesday Novant Health can move forward with its plans to purchase two North Carolina hospitals from Community Health Systems, despite a request from the Federal Trade Commission to stall the deal.
    • “The antitrust agency sued to block the deal in January, claiming it would decrease competition and drive up consumer prices in the greater Lake Norman, North Carolina, area by allotting Novant more than 65% control of the region’s inpatient market.
    • “U.S. district judge Kenneth Bell denied the FTC’s request for an injunction, saying the hospitals are likely to shutter absent a deal.”
  • On a related note, the Wall Street Journal continues its series on hospital consolidation.

From the public health and medical research front,

  • The Washington Post reports
    • “A 59-year-old male resident of Mexico died after being infected with a bird flu subtype never before confirmed to have spread to humans, the World Health Organization said Wednesday.”
    • “The man, who suffered from other underlying health conditions, had no known exposure to poultry or other animals before being formally diagnosed by a laboratory with the H5N2 subtype of avian flu. The case marks the first time a human has been confirmed to be infected with this subtype, and the first time an avian H5 virus was confirmed in a person in Mexico.
    • “Due to the constantly evolving nature of influenza viruses, WHO continues to stress the importance of global surveillance,” WHO said in a statement. “This case does not change the current WHO recommendations on public health measures and surveillance of influenza,” it added, rating current risks to the general population as “low.”
  • and
    • “‘Unusual’ cancers emerged after the pandemic. Doctors ask if covid is to blame.”‘Unusual’ cancers emerged after the pandemic. Doctors ask if covid is to blame.
    • “It’s not a new idea that viruses can cause or accelerate cancer. But it will probably be years before answers emerge about covid and cancer.”
  • Mercer Consulting offers bird flu considerations for employers.
  • The NIH Director in her blog relates,
    • “The ability to communicate using only your thoughts might sound like the stuff of science fiction. But for people who don’t have the ability to speak or move due to injury or disease, there’s great hope that this may one day be possible using brain-computer interfaces (BCIs) that can “read” relevant brain signals and translate them into written or spoken words. A research team has made a preliminary advance in this direction by showing for the first time that a computerized brain implant can decode internal speech with minimal training.
    • “In the new NIH-supported study, researchers implanted such a device in a brain area known to be important for representing spoken words called the supramarginal gyrus in two people with tetraplegia, a condition marked by full body paralysis from the neck down due to cervical spinal cord injury. The researchers found that the device could decode several words the participants “spoke” only in their minds. While we are far from using such a device to decode whole sentences or even phrases, and the exact mechanisms of internal speech are still under study, the findings, reported in Nature Human Behavior , are notable because it had been unclear whether the brain signals involved in thinking words could be reproducibly translated. * * *
    • “While there is much more to learn about how to decode internal speech more reliably across individuals, the findings offer proof-of-concept for a high-performance internal speech BCI. The new research adds to a growing portfolio of rapidly advancing technologies supported by the BRAIN Initiative that could one day routinely restore the ability to communicate for those who can no longer speak or even move, including people with brain injuries, paralysis, or diseases such as amyotrophic lateral sclerosis (ALS).”
  • Per BioPharma Dive,
    • “Expert advisers to the Food and Drug Administration will need to weigh whether Eli Lilly’s experimental Alzheimer’s disease drug donanemab is widely effective or should be restricted only to people who have deposits in their brains of a toxic protein called tau, according to documents released Thursday ahead of a key regulatory meeting next week.
    • “The FDA will also ask its advisers to provide guidance on whether and when it’s safe for people to stop taking donanemab based on reductions in another toxic protein called amyloid, as well as on the risks of mild brain swelling that can result from donanemab and other drugs of its type.”The FDA will also ask its advisers to provide guidance on whether and when it’s safe for people to stop taking donanemab based on reductions in another toxic protein called amyloid, as well as on the risks of mild brain swelling that can result from donanemab and other drugs of its type.
    • “If approved, donanemab would be the third amyloid-targeted drug to launch. Biogen has withdrawn the first, called Aduhelm, after much controversy and few sales. Eisai, along with Biogen, more recently won approval of a second, called Leqembi, which brought in sales of $19 million in the first quarter.”

From the U.S. healthcare business front,

  • Health Affairs offers advice to employers about how to help employees reduce their healthcare costs.
    • “Employers, and especially small employers, may have limited ability to affect the direct causes of increasing spending—notably high prices. However, they do have some options that could lower the burden of out-of-pocket costs for their employees. Employers could partner with insurers to use more innovative cost-sharing structures in the health insurance benefits offered to their employees. In addition, they could increase the use of benefit designs that distribute costs more equitably, which may improve affordability for low- to middle-income workers.”
  • HR Dive tells us,
    • “In an era when retirement is frequently at the forefront of ageism, diversity and benefits conversations, older adults now make up a larger share of American workforce members over the age of 55. The Employee Benefit Research Institute found that adults aged 65 and older made up 29.5% of the workforce in 2023, compared to an estimated 23% in 2000.
    • “Additionally, EBRI noted that the share of Hispanic workers aged 55 and older more than doubled, with the share of older White workers dropping from about 87% to 81%.
    • “The changing demographic characteristics of the older workforce are “important considerations for employers to understand, as older workers and a more diverse work force calls for additional or new answers to the optimal design of employee benefit plans,” Craig Copeland, director of wealth benefits at EBRI, said in a release.”
  • EBRI also released a Fast Facts publication informing us that “HSAs Reduce Use of Outpatient Services and Prescription Drugs, Increase Use of Inpatient Services; Overall Spending Unaffected.”

Midweek Update

David Ermer–AHRQ, CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Medical / Rx research, NIH, No Surprises Act, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The House Appropriations Committee tells us, “Today, the House Appropriations Financial Services and General Government Subcommittee met to consider its Fiscal Year 2025 bill. The measure was approved by the Subcommittee.”
  • This bill provides appropriations for OPM and the FEHBP. The Committee summary of the bill describes its OPM appropriations as follows —
    • “Provides $477 million for the Office of Personnel Management (OPM), which is $31.4 million below the FY25 Budget Request and $29.1 million above the FY24 enacted level.”
  • Govexec informs us,
    • “Senate Democrats have vowed to move quickly on legislation protecting Americans’ access to in vitro fertilization and other forms of assistive reproductive technology, including a provision expanding federal workers’ access to those treatments as part of the government’s employer-sponsored health insurance program.
    • “On Monday, Sens. Tammy Duckworth, D-Ill., Patty Murray, D-Wash., and Cory Booker, D-N.J., introduced the Right to IVF Act, a repackaging of three separate previously introduced bills on reproductive health services.
    • “Included is the Family Building FEHB Fairness Act, first introduced last year by Duckworth, which would require the Federal Employees Health Benefits Program to cover additional costs associated with IVF, and would expand coverage to all types of assisted reproductive technology, such as gamete and zygote intrafallopian transfer.”
  • Govexec also pointed out this OPM Inspector General brief that summarizes OPM OIG recommendations that have been open for more than six months as of March 31, 2024. The FEHBlog understands why the FEHB open recommendations remain outstanding
  • Healthcare Dive lets us know,
    • “Congress appears to be inching toward injecting more transparency into a controversial program that forces drugmakers to give safety-net hospitals steep discounts on drugs.
    • “It would be a win for pharmaceutical manufacturers, which have long lobbied that hospitals be required to account for their savings in the 340B program — or that it be overhauled entirely.
    • “The latter appears unlikely, after lawmakers on both sides of the aisle expressed blanket support for 340B during a House Oversight and Investigations subcommittee hearing on Tuesday. However, members said they approved of more oversight to try and stop financial gaming in the program.
    • “Though “we’re all in support of 340B … I think nearly all of us agree that the status quo is not acceptable,” said Rep. Larry Bucshon, R-Ind.”
  • Yesterday, the U.S. Preventive Services Task Force released a final recommendation concerning “Falls Prevention in Community-Dwelling Older Adults: Interventions.” Its recommendations align with the recommendations currently in force.
  • Thompson Reuters Practical Law relates,
    • “In litigation under the No Surprises Act (NSA), a district court concluded that there is no cause of action for health providers to enforce awards involving surprise billing disputes under the NSA’s independent dispute resolution (IDR) process (Guardian Flight LLC & Med-Trans Corp. v. Health Care Serv. Corp., (N.D. Tex. May 30, 2024)).”
  • The American Hospital Association News shares the organization’s “comments [submitted’ June 5 on the Centers for Medicare & Medicaid Services’ inpatient prospective payment system proposed rule for fiscal year 2025, expressing support for several provisions, including certain policies supporting low-volume and Medicare-dependent hospitals, and several aspects of CMS’ quality-related proposals. However, AHA raised concerns about the rule’s proposed payment updates.”

From the public health and medical research front,

  • CNN reports,
    • “About 61% of US adults will have cardiovascular disease by 2050, new research from the American Heart Association predicts. The biggest driver of this trend will be the large number of people who have or will develop high blood pressure, which makes them much more likely to develop dangerous problems like a heart attack or stroke.
    • “Other cardiovascular problems include heart attacks, arrhythmias like atrial fibrillation or a-fib, heart failure and congenital heart disease. * * *
    • In the research published Tuesday, the association predicts that 45 million adults will have some form of cardiovascular disease – excluding high blood pressure – or will have a stroke in 2050, up from 28 million in 2020.
  • The New York Times reports,
    • One of the nation’s premier medical advisory organizations has weighed in on long Covid with a 265-page report that recognizes the seriousness and persistence of the condition for millions of Americans.
    • More than four years since the start of the coronavirus pandemic, long Covid continues to damage many people’s ability to function, according to the National Academies of Sciences, Engineering and Medicine, a nongovernmental institution that advises federal agencies on science and medicine.
  • and
    • “A committee of advisers to the Food and Drug Administration voted on Wednesday to update the formula for the Covid vaccine ahead of an anticipated fall immunization campaign, now an annual step to try to offer better protection against versions of the virus in circulation.
    • “The unanimous vote by the 16 advisers recommends a formula aimed at combating the variant JN.1, which dominated infections in the United States in February, or a version of it. In recent weeks, JN.1 has been overtaken by descendants known as KP.2 and KP.3.
    • “In the coming weeks, the F.D.A. is expected to formally recommend a variant target for vaccine makers for the next round of shots in the late summer or early fall. Any decision involves some educated guesswork, given that any new vaccine formula won’t be available until months after a variant becomes dominant.
    • “It’s becoming clear that the ideal timing for a vaccine composition decision remains elusive,” said Jerry Weir, an official with the F.D.A.’s vaccine division.”
  • Per Biopharma Dive,
    • “A saliva test may improve screening for prostate cancer by identifying people at higher risk based on genotype, researchers said Friday.”A saliva test may improve screening for prostate cancer by identifying people at higher risk based on genotype, researchers said Friday.
    • “Data presented at the American Society of Clinical Oncology annual meeting suggest the test can support prostate cancer diagnosis in people who are missed by other screening methods.
    • “The researchers are now comparing the saliva test to several screening methods such as fast MRI scans and prostate-specific antigen (PSA) blood tests to determine the best approach.”
  • and
    • “Eli Lilly’s drug tirzepatide — sold as Zepbound for obesity — continues to show promise in the liver disease MASH. Clinical trial data disclosed in an abstract ahead of a European medical conference indicates that, after one year, the shot helped improve liver fibrosis without worsening MASH in just over half of treated participants, compared with 30% of those given placebo. Lilly had hinted at the study’s success earlier this year, but the full data will provide a more complete view of tirzepatide’s potential. The abstract’s release comes one day after Viking Therapeutics released trial data for its MASH pill VK2809 and less than two months after Madrigal Pharmaceuticals won U.S. approval of the first MASH drug.”
  • The Institute for Clinical and Economic Research “today posted a Protocol outlining how it will conduct the fourth annual assessment of how well major insurers’ prescription drug coverage policies align with a set of fair access standards. These standards were developed by ICER with expert input from patient advocates, clinician specialty societies, payers, pharmacy benefit managers, and life science companies.”
  • Per MedPage Today,
    • “The CDC finalized new guidelines that recommend doxycycline post-exposure prophylaxis (doxy PEP) for at-risk gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW) to prevent bacterial sexually transmitted infections (STIs).”The CDC finalized new guidelines that recommend doxycycline post-exposure prophylaxis (doxy PEP) for at-risk gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW) to prevent bacterial sexually transmitted infections (STIs).
    • “Healthcare providers should discuss and offer doxy PEP to people in these populations with a history of at least one bacterial STI — specifically syphilis, chlamydia, gonorrhea — in the last 12 months, Lindley Barbee, MD, of the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention, and colleagues wrote in Morbidity and Mortality Weekly Report.”
    • “Doxy PEP represents the first new STI prevention tool in decades, at a time when innovation in the nation’s fight against STIs is desperately needed,” said Barbee in a CDC statement.
  • The National Institutes of Health announced,
    • “The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has released its plan for advancing H5N1 influenza basic research and translating those findings into strategies and interventions that can benefit people. The research agenda focuses on four key objectives: increasing understanding of the biology of H5N1 viruses and the factors that influence their ability to transmit and cause disease; developing and evaluating prevention strategies, such as vaccines; advancing existing and novel treatments, including antivirals and monoclonal antibodies; and supporting strategies for detecting H5N1 virus. The NIAID Research Agenda for 2024 H5N1 Influenza – May 2024 aligns with the NIAID role in the federal public health response to the U.S. outbreak of H5N1 influenza in people, dairy cows and other animals.”The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has released its plan for advancing H5N1 influenza basic research and translating those findings into strategies and interventions that can benefit people. The research agenda focuses on four key objectives: increasing understanding of the biology of H5N1 viruses and the factors that influence their ability to transmit and cause disease; developing and evaluating prevention strategies, such as vaccines; advancing existing and novel treatments, including antivirals and monoclonal antibodies; and supporting strategies for detecting H5N1 virus. The NIAID Research Agenda for 2024 H5N1 Influenza – May 2024 aligns with the NIAID role in the federal public health response to the U.S. outbreak of H5N1 influenza in people, dairy cows and other animals.”
  • The Washington Post reports, “Male birth control gel shows promise in early-stage clinical trials. “A National Institutes of Health official said the findings marked a milestone, even if the product is probably years away.”

From the U.S. healthcare business front,

  • KFF informs us,
    • The Medical Loss Ratio (MLR) provision of the Affordable Care Act (ACA) limits the amount of premium income that insurers can keep for administration, marketing, and profits. Insurers that fail to meet the applicable MLR threshold are required to pay back excess profits or margins in the form of rebates to individuals and employers that purchased coverage.
    • In the individual and small group markets, insurers must spend at least 80% of their premium income on health care claims and quality improvement efforts, leaving the remaining 20% for administration, marketing expenses, and profit. The MLR threshold is higher for large group insurers, which must spend at least 85% of their premium income on health care claims and quality improvement efforts. MLR rebates are based on a 3-year average, meaning that rebates issued in 2024 will be calculated using insurers’ financial data in 2021, 2022 and 2023 and will go to people and businesses who bought health coverage in 2023.
    • This analysis, using preliminary data reported by insurers to state regulators and compiled by Mark Farrah Associates, finds that insurers estimate they will issue a total of about $1.1 billion in MLR rebates across all commercial markets in 2024. Since the ACA began requiring insurers to issue these rebates in 2012, a total of $11.8 billion in rebates have already been issued to individuals and employers, and this analysis suggests the 2012-2024 total will rise to about $13 billion when rebates are issued later this year.
  • TechTarget calls our attention to the fact that “As providers seek to advance patient-centered care, many behavioral health organizations are turning to their EHR vendors to support integrated care models, according to a KLAS report.” Yippee.
  • Beckers Hospital Review lets us know,
    • “U.S. bankruptcy Judge Chris Lopez authorized the sale dates for Dallas-based Steward Health Care’s 31 hospitals during a June 3 hearing. “U.S. bankruptcy Judge Chris Lopez authorized the sale dates for Dallas-based Steward Health Care’s 31 hospitals during a June 3 hearing. 
    • “The sales will be conducted in two rounds. The first round, which includes the health system’s physician group, Stewardship Health, and all Steward hospitals excluding its Florida facilities and some of the Texas hospitals, will have a bid deadline of June 24 and a first sale hearing July 11.
    • “The second round includes Steward’s Florida hospitals and four of its Texas facilities, with a bid deadline of Aug. 12 and a sale hearing of Aug. 22.”
  • Beckers Payer Issues tells us about the payers that landed on the 2024 Fortune 500.

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Medical / Rx research, NIH, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The American Hospital Association New tells us,
    • The House Energy and Commerce Oversight and Investigations subcommittee June 4 hosted a hearing to discuss oversight of the 340B Drug Pricing Program. AHA sent a letter to the subcommittee for the hearing, urging Congress to protect the program and highlighted its value to hospitals and health systems.
  • Roll Call offers more details on this policy issue.
  • Per a Health and Human Services press release,
    • “The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS) in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA), today welcomed 10 new states into the Certified Community Behavioral Health Clinic (CCBHC) Medicaid Demonstration Program, after they successfully developed the necessary state-level infrastructure and worked with providers in their states to develop programs that meet CCBHC standards: Alabama, Illinois, Indiana, Iowa, Kansas, Maine, New Hampshire, New Mexico, Rhode Island and Vermont. The CCBHC Medicaid Demonstration Program provides states with sustainable funding that helps them expand access to mental health and substance use services, supporting President Biden’s Unity Agenda and the Biden-Harris Administration’s efforts to tackle the country’s mental health and addiction crises. The expansion of the program directly supports the President’s national strategy to transform our behavioral health system and builds on the Administration’s previous work to build a better crisis continuum of care, including through the transition to the 988 Suicide & Crisis Lifeline, add a new mobile crisis benefit to Medicaid and new crisis codes to the Medicare program.”
  • NBC News reports,
    • A Food and Drug Administration advisory panel on Tuesday declined to recommend the approval of MDMA as a treatment for post-traumatic stress disorder, a major setback for advocates who have long pushed to include psychedelics in treating mental health disorders.
    • The two votes — one for the treatment’s efficacy and one for its safety, by the agency’s Psychopharmacologic Drugs Advisory Committee — marked the first time that FDA advisers have considered a Schedule I psychedelic for medical use. If approved by the FDA, it would be the first new treatment for PTSD in more than two decades.
    • The votes reflected panel members’ struggle to balance the need for new PTSD treatments against serious concerns about the data submitted by drugmaker Lykos Pharmaceuticals, which was marred by inconsistencies, poor study design and allegations of misconduct.
    • “It sounds like MDMA has really impacted a number of people in positive ways, but it seems that there are so many problems with the data,” said Melissa Decker Barone, an adjunct assistant professor in the department of psychiatry at the University of Maryland School of Medicine. * * *
    • Last week, the Institute for Clinical and Economic Review, a non-profit group that evaluates the cost of drugs, said patients and providers in the trial treated psychedelics “more like a religious movement than like pharmaceutical products.” * * *
    • “The decision will now go to the FDA, which is expected to make a final ruling by August 11. The committee’s vote is only a recommendation, and the agency doesn’t have to follow its advice, although it usually does.”
  • Reuters adds,
    • “The FDA’s staff in separate documents said vaccine makers developing the new booster shots may need to consider targeting one of the JN.1 subvariants such as KP.2, as further evolution of the virus could take it away from the older strain. * * *”The FDA’s staff in separate documents said vaccine makers developing the new booster shots may need to consider targeting one of the JN.1 subvariants such as KP.2, as further evolution of the virus could take it away from the older strain. * * *
    • “The FDA staff’s review for updating viral strains for vaccines in the U.S. differs from that of the World Health Organization’s advisers, who in April recommended targeting only the JN.1 strain.
    • “Since then, the subvariant KP.2 has become the dominant strain in the U.S., estimated to account for about 28.5% of cases over a two-week period ended May 25, according to data from the U.S. Centers for Disease Control and Prevention.”
  • Healthcare Dive informs us,
    • “Scan Health Plan won a lawsuit that alleged the federal government had improperly calculated its 2024 Medicare Advantage star ratings, which it argued could cost the insurer millions of dollars. “Scan Health Plan won a lawsuit that alleged the federal government had improperly calculated its 2024 Medicare Advantage star ratings, which it argued could cost the insurer millions of dollars. 
    • “The case centered around recent changes in how the CMS determined quality measures for the private Medicare plans. Scan alleged the agency didn’t follow its stated methodology, causing its rating to drop “precipitously” to 3.5 stars and risking $250 million in quality bonus payments. 
    • “The U.S. District Court for the District of Columbia ruled for the California-based insurer Monday, barring the federal government from using Scan’s original 2024 Star Rating for quality bonus decisions.”

From the public health and medical research front,

  • The New York Times reports,
    • “Surgeons removed the kidney of a genetically engineered pig from a critically ill patient last week after the organ was damaged by inadequate blood flow related to a heart pump that the woman had also received, according to officials at NYU Langone Transplant Institute.”Surgeons removed the kidney of a genetically engineered pig from a critically ill patient last week after the organ was damaged by inadequate blood flow related to a heart pump that the woman had also received, according to officials at NYU Langone Transplant Institute.
    • “The patient, Lisa Pisano, 54, who is still hospitalized, went back on kidney dialysis after the pig’s organ was removed. She lived with the transplanted organ for 47 days, Dr. Robert Montgomery, director of the institute, said. The kidney showed no signs of organ rejection.
    • “Lisa is in stable condition, and her left ventricular assist device is still functioning,” Dr. Montgomery said, referring to the heart pump. “We are hoping to get Lisa back home to her family soon.”
  • Health Day lets us know,
    • “As the H5N1 avian flu continues to spread among dairy cows in the United States, nearly 5 million doses of flu vaccine are now being prepared for possible use in humans.
    • “Since the outbreak in livestock began this spring, bird flu has been confirmed in three humans who worked on dairy farms in Texas and Michigan, and health experts are concerned the virus could mutate to the point where it could spread easily among humans.
    • “In response, vaccine maker CSL Seqirus announced last week that it has been tasked with making the additional doses of flu vaccine at its North Carolina plant.
    • “It utilizes a highly scalable method of production and is currently positioned to deliver up to 150 million influenza vaccine doses to support an influenza pandemic response within six months of a pandemic declaration,” the company noted in a news release.”
  • ABC News relates,
    • “Cases of whooping cough are on the rise across the United States, data from the Centers for Disease Control and Prevention shows. “Cases of whooping cough are on the rise across the United States, data from the Centers for Disease Control and Prevention shows.
    • “There have been at least 4,864 whooping cough cases reported this year. This is nearly three times higher than the 1,746 cases reported at the same time last year.
    • “The number of cases for 2024 is similar to those seen in 2018-2019, before the COVID-19 pandemic.
    • “The national trends mirror those seen in many U.S. states. The Oregon Health Authority said Thursday that 178 cases have been reported as of May 29, a 770% increase from the 20 cases reported by at the same time in 2023, according to local ABC News affiliate KATU. * * *
    • “There are two types of vaccines used today to protect against whooping cough: diphtheria, tetanus, and pertussis (DTaP) vaccine for babies and children younger age 7 and tetanus, diphtheria, and pertussis (Tdap) vaccines for children aged 7 and older, adults and pregnant women.
    • “People often think ‘Well once you get vaccinated you have lifelong immunity,’ and that’s actually not the case. You certainly need to get those booster doses,” Madad said.”
  • Beckers Hospital Review points out
    • “Mississippi is the unhealthiest state in the nation for older adults in 2024, according to the United Health Foundation’s 12th annual “America’s Health Rankings Senior Report.”
    • “The May 30 report provides a comprehensive look at the health and well-being of Americans 65 and older.   
    • “State rankings were derived from 35 measures across five categories of health: social and economic factors, physical environment, behaviors, clinical care and health outcomes. The full methodology can be viewed here.“
  • The National Institutes of Health shared their most recent research insights.
  • NIH announced in various press releases,
    • “Two clinical trials have launched to examine a novel long-acting form of HIV pre-exposure prophylaxis (PrEP) in cisgender women and people who inject drugs. The mid-stage studies will assess the safety, acceptability, and pharmacokinetics (how a drug moves through the body) of lenacapavir, an antiretroviral drug administered by injection every six months. The studies are sponsored and funded by Gilead Sciences, Inc., and implemented through the HIV Prevention Trails Network (HPTN). The HPTN is supported by grants from the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID), with scientific collaboration on this study and others from the National Institute on Drug Abuse (NIDA) as well as co-funding from NIDA and other NIH institutes.”
  • and
    • “A five-minute cognitive assessment coupled with a decision tree embedded in electronic medical records, known as 5-Cog, improved dementia diagnosis and care, based on a clinical trial funded by the National Institutes of Health (NIH) and conducted in an urban primary care setting. Researchers evaluated the system among 1,200 predominantly Black and Hispanic American older adults who presented to primary care with cognitive concerns. The findings appear in Nature Medicine. * * *
    • “5-Cog combines three metrics designed to test memory recall, the connection between cognition and gait, and the ability to match symbols to pictures. Importantly, these tests are easy to perform, relatively quick, and are not affected by reading level or ethnic/cultural differences among patients. * * *
    • “Cognitive impairment is often difficult to diagnose in the busy primary care setting and, as a result, beneficial care plans are likely underutilized. This can result in lack of detection, which delays the start of support services and critical planning. Underdiagnosis is even more prevalent among older Black and Hispanic patients compared to white patients, suggesting this tool may be even more valuable to the populations represented in the study.”
  • and
    • “For military members and veterans who have been diagnosed with post-traumatic stress disorder (PTSD), adding a service dog to their usual care could reduce the severity of PTSD symptoms, feelings of anxiety, and lower depression while enhancing their quality of life and psychosocial functioning, according to a study funded by the National Institutes of Health.”For military members and veterans who have been diagnosed with post-traumatic stress disorder (PTSD), adding a service dog to their usual care could reduce the severity of PTSD symptoms, feelings of anxiety, and lower depression while enhancing their quality of life and psychosocial functioning, according to a study funded by the National Institutes of Health.
    • “The trial, which is the largest nationwide study comparing service dog partnerships to usual care alone, included 156 military members and veterans diagnosed with PTSD. Participants were recruited through the database of K9s For Warriors, an accredited non-profit service dog provider. Under U.S. federal law(link is external), service dogs are “individually trained to work or perform tasks for people with disabilities.”

From the U.S. healthcare business front,

  • Per MedTech Dive,
    • “Abbott received clearance from the Food and Drug Administration for an over-the-counter glucose monitor. “Abbott received clearance from the Food and Drug Administration for an over-the-counter glucose monitor. 
    • “The device, called Lingo, first debuted in the U.K. last year as a sensor for people who don’t have diabetes to track glucose spikes. Abbott hopes to bring it to the U.S. but has shared few details about its plans. 
    • “With the recent FDA clearance, Abbott will compete with Dexcom for a new category of over-the-counter glucose monitors. Dexcom received FDA clearance for the first over-the-counter CGM in March.”
  • Per Healthcare Dive,
    • “Steward Health Care is aggressively courting new debtor-in-possession lenders to stay afloat amid its Chapter 11 restructuring process. Without additional capital, the health system says it will run out of funds by June 14.
    • “Medical Properties Trust, Steward’s landlord and initial DIP financier, appears unlikely to step up to the plate to offer more funds.
    • “The Dallas-based health system, which employs 30,000 people across eight states, declared bankruptcy last month. At the time, the real estate investment trust put up $75 million of DIP financing and said it might offer up to $225 million more, contingent upon successful asset sales.
    • “But MPT has since shown little interest in providing additional financial support for Steward. As of Friday, Steward’s attorneys told the court that MPT had made no further commitment to pony up funds, leaving the health system in immediate need of new funding.”

 

Monday Roundup

David Ermer–Generative AI, NIH, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The FEHBlog travelled back to DC yesterday,
  • Per a Department of Health and Human Services press release,
    • “Today, the U.S. Department of Health and Human Services’ (HHS) Health Resources and Services Administration (HRSA) announced a combined investment of $15 million over four years through the Rural Maternity and Obstetrics Management Strategies (Rural MOMS) Program to improve maternal health in rural communities and a new program focused on strengthening maternal care and reducing disparities in the Delta region (within Alabama, Arkansas, Illinois, Kentucky, Louisiana, Mississippi, Missouri, and Tennessee). HRSA Deputy Administrator Jordan Grossman highlighted these strategic investments today in Flagstaff, AZ, during the third state convening of HRSA’s Enhancing Maternal Health Initiative.”
  • The NIH Director in her blog tells us,
    • The NIH Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative has expanded scientists’ understanding of the human brain in recent years, offering fascinating insights into the ways that individual cells and complex neural circuits interact dynamically to enable us to think, feel, and act. But neuroscientists still have much more to learn about how our brains are put together at the most fundamental, subcellular level.  
    • As a step in that direction, in a new study supported in part by the NIH BRAIN Initiative and reported in the journal Science , researchers have created the most detailed nanoscale resolution map ever produced of a cubic millimeter of brain tissue, about the size of half a grain of rice. * * *
    • While there is plenty still left to uncover, the findings offer proof-of-principle that it’s possible to visualize the brain at this very detailed level. This is crucial groundwork for new research now supported by the BRAIN Initiative Connectivity Across Scales (BRAIN CONNECTS) program. BRAIN CONNECTS will develop and scale up tools to produce an equally detailed map of a complete mouse brain, which is about 1,000 times larger than the human brain fragment. The researchers now hope their 3D map and others like it will be put to work to understand both normal and disordered brain function more fully.

From the public health and medical research front,

  • The AMA News lets us know what doctors wish their patients knew about the measles.
  • NIH announced.
    • “In a proof-of-concept study, researchers at the National Institutes of Health (NIH) have developed an artificial intelligence (AI) tool that uses routine clinical data, such as that from a simple blood test, to predict whether someone’s cancer will respond to immune checkpoint inhibitors, a type of immunotherapy drug that helps immune cells kill cancer cells. The machine-learning model may help doctors determine if immunotherapy drugs are effective for treating a patient’s cancer. The study, published June 3, 2024, in Nature Cancer, was led by researchers at the National Cancer Institute’s (NCI) Center for Cancer Research and Memorial Sloan Kettering Cancer Center in New York. NCI is part of the National Institutes of Health. * * *
    • “The researchers noted that larger prospective studies are needed to further evaluate the AI model in clinical settings. They have made their AI model, called Logistic Regression-Based Immunotherapy-Response Score (LORIS), publicly available at https://loris.ccr.cancer.gov. The tool estimates the likelihood of a patient responding to immune checkpoint inhibitors based on data on the six variables described above.”
  • Health Day tells us,
    • “About one in eight U.S. seniors will be treated for a traumatic brain injury, typically during a fall, a new study finds.” About one in eight U.S. seniors will be treated for a traumatic brain injury, typically during a fall, a new study finds.
    • “Medicare data shows that about 13% of seniors suffered a severe concussion during an average follow-up period of 18 years, researchers report.
    • “Although these injuries can be treated, they increase the risk of serious conditions like dementia, Parkinson’s disease, seizures, heart disease, depression and anxiety, they added.
    • “The number of people 65 and older with TBI is shockingly high,” said senior researcher Dr. Raquel Gardner, a neurologist with the Sheba Medical Center in Israel.”
  • Healio points out,
    • “Statin therapy was tied to a 5-year CVD risk reduction in adults aged 75 years and older.”Statin therapy was tied to a 5-year CVD risk reduction in adults aged 75 years and older.
    • “Statin use did not increase the risk for major adverse events, such as liver dysfunction.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Nonprofit hospital margins hit 4.3% in April, up 33% year over year, according to Kaufman Hall’s “National Hospital Flash Report” released June 3.”Nonprofit hospital margins hit 4.3% in April, up 33% year over year, according to Kaufman Hall’s “National Hospital Flash Report” released June 3.
    • “Kaufman Hall examined data from 1,300 hospitals in Syntellis Performance Solutions’ database and found that while hospital margins are improving overall, so is the gap between the highest and lowest performing hospitals. The best performing hospitals had a margin of 28.9%, compared to -16.1% for the worst performing hospitals. * * *
    • “Of note, the data revealed:
      • “1. Outpatient revenue increased 10% year over year in April.
      • “2. Average length of stay dropped 4% year over year in April.
      • “3. Emergency department visits increased to hit pre-pandemic levels.”
  • BioPharma Dive informs us,
    • “An experimental GLP-1 pill helped people with obesity lose significantly more weight than a placebo over three months, according to summary results revealed by developer Structure Therapeutics Monday.
    • “Structure’s drug led to an average reduction in body weight of 6.2% over placebo. One-third of those on the drug, dubbed GSBR-1290, lost 10% or more of their body weight, compared to zero of those given placebo.”
  • Per MedTech Dive,
    • “BD has agreed to buy Edward Lifesciences’ critical care group for $4.2 billion in cash, ending Edwards’ plan to spin off the business.
    • “In a Monday announcement, BD highlighted the group’s patient monitoring technologies and artificial intelligence-enabled clinical decision products that will add to BD’s existing businesses. Edwards’ critical care unit grew revenue by 8.5% year over year to $928.1 million in 2023.
    • “RBC Capital Markets analyst Shagun Singh said the deal would streamline Edwards. “Notably, the transaction creates a pure-play structural heart company positioning them for strategic initiatives that could further create shareholder value,” Singh wrote in a note to investors.”

Thursday Miscellany

David Ermer–CDC, CMS, Medical / Rx research, Mental health care, NIH, Telehealth, U.S. Healthcare, Wellness–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Department of Health and Human Services announced,
    • Today the U.S. Department of Health and Human Services, through its Administration for Community Living, released “Aging in the United States: A Strategic Framework for a National Plan on Aging – PDF.” The report lays the groundwork for a coordinated effort – across the private and public sectors and in partnership with older adults, family caregivers, the aging services network, and other stakeholders – to create a national set of recommendations for advancing healthy aging and age-friendly communities that value and truly include older adults. The national plan on aging will advance best practices for service delivery, support development and strengthening of partnerships within and across sectors, identify solutions for removing barriers to health and independence for older adults, and more. Developed by leaders and experts from 16 federal agencies and departments working together through the Interagency Coordinating Committee (ICC) on Healthy Aging and Age-Friendly Communities, the report also reflects input from community partners and leaders in the aging services network.
  • The Assistant Secretary of Labor for Employee Benefit Security, Lisa Gomez, reminds us,
    • “May is Mental Health Awareness Month, reminding us of the critical need to prioritize mental well-being – especially in the workplace where many spend a significant portion of their time. Did you know that more than 1 in 5 adults in America live with a mental illness? Mental health issues can affect job performance, relationships and overall well-being. Understanding your rights and support systems can make a world of difference. 
    • “Here are three actions you can take to get the mental health care you deserve through your job-based health plan: 
    • “Use your benefits: * * * For more information, read our publication “Understanding Your Mental Health and Substance Use Disorder Benefits.”
    • “Don’t take no for an answer: * * * You also can look at our publication “Filing a Claim for Your Benefits” for steps to help navigate this process. 
    • “Contact the Department for help:  Know that support for your mental health journey is available – you don’t have to go through it alone. One source of support is found by contacting a benefits advisor with the Department’s Employee Benefits Security Administration at askebsa.dol.gov or by calling 1-866-444-3272 for assistance with any questions or problems you encounter when trying to use the mental health and substance use disorder benefits under your job-based health plan. The benefits advisors can help you understand your rights, your health plan and its appeal process.”
  • The American Hospital News lets us know,
    • “The Centers for Disease Control and Prevention May 29 published a blog co-authored by AHA, the National Institute for Occupational Safety and Health and the Agency for Healthcare Research and Quality, highlighting efforts by federal agencies and the hospital field to address the mental health and well-being of health care workers following incidents of workplace violence. The blog contains several resources, such as AHA’s Hospitals Against Violence Initiative, the Building a Safer Workplace and Community infographic, and information about #HAVhope Friday on June 7 * * *.
  • HR Dive informs us,
    • “Employers run afoul of federal law when they fire someone for not disclosing a disability during a job interview or for waiting until after they were hired to ask for an accommodation, the U.S. Equal Employment Opportunity Commission warned in a May 21 lawsuit.
    • “Per the complaint in EEOC v. All Day Medical Care Clinic, LLC, on her first day of work, a scheduling assistant for a Maryland-based healthcare provider notified the CEO she had a vision impairment and needed a magnifier and Zoomtext software as an accommodation. The CEO allegedly advised her that things would have been different if she’d mentioned her disability and accommodation needs during her interview and told her to leave, according to court documents.
    • “The EEOC sued the healthcare provider for allegedly violating the Americans with Disabilities Act. Under the ADA, “job applicants do not need to reveal their disabilities before being hired,” Debra Lawrence, regional attorney for the EEOC’s Philadelphia district office, explained in a press release. “When an employer penalizes an employee for not raising issues of disability and reasonable accommodation, it is requiring the employee to reveal information the employee legally does not have to divulge,” Lawrence said. All Day Medical Care did not respond to a request for a comment prior to press time.”

From the public health and medical research front,

  • The New York Times reports,
    • “A third farmworker in the United States has been found to be infected with bird flu, heightening concerns about an outbreak among dairy cattle first identified in March.”A third farmworker in the United States has been found to be infected with bird flu, heightening concerns about an outbreak among dairy cattle first identified in March.
    • “The worker is the first in this outbreak to have respiratory symptoms, including a cough, sore throat and watery eyes, which generally increase the likelihood of transmission to other people, federal officials said on Thursday.
    • “The other two people had only severe eye infections, possibly because of exposure to contaminated milk.
    • “All three individuals had direct exposure to dairy cows, and so far none has spread the virus to other people, Dr. Nirav Shah, principal deputy director of the Centers for Disease Control and Prevention, said at a news briefing.”
  • The National Institutes of Health announced,
    • “Using a combination of cutting-edge immunologic technologies, researchers have successfully stimulated animals’ immune systems to induce rare precursor B cells of a class of HIV broadly neutralizing antibodies (bNAbs). The findings, published today in Nature Immunology, are an encouraging, incremental step in developing a preventive HIV vaccine.”
  • The Institute for Clinical and Economic Review released,
    • “its revised Evidence Report assessing the comparative clinical effectiveness and value of ensifentrine (Verona Pharma) for the treatment of chronic obstructive pulmonary disease (COPD).”its revised Evidence Report assessing the comparative clinical effectiveness and value of ensifentrine (Verona Pharma) for the treatment of chronic obstructive pulmonary disease (COPD).
    • “COPD is a common cause of severe respiratory problems,” said ICER’s Chief Medical Officer, David Rind, MD. “People with COPD can experience persistent shortness of breath and fatigue that can significantly affect their daily activities. Current evidence shows that ensifentrine decreases exacerbations when used in combination with some current inhaled therapies and is well-tolerated by patients, but there are uncertainties about how much benefit it may add to unstudied combinations of inhaled treatments.” * * *
    • “Key Clinical Findings“Key Clinical Findings
      • “ICER does not have significant concerns about harms with ensifentrine. We have high certainty that ensifentrine added to maintenance therapy, compared with maintenance therapy alone, results in at least a small net health benefit, and may result in substantial net health benefit (“B+”). We have somewhat greater certainty in the benefits when ensifentrine is added to the regimens studied in the clinical trials than when added to optimized modern inhaler therapies for COPD.
    • “Key Cost-Effectiveness Findings
      • “Ensifentrine has not yet been approved by the FDA, and the manufacturer has not announced a US price if approved. ICER has calculated a health-benefit price benchmark (HBPB) for ensifentrine to be between $7,500 to $12,700 per year.”
  • The Centers for Medicare Services is contemplating moving coverage of PreExposure Prophylaxsis using Antiviral Therapy to prevent HIV infection from Medicare Part D to Medicare Part B.
  • The Wall Street Journal relates,
    • “Screens are inherently harmful to our sleep, right?
    • “It isn’t that black and white, some sleep experts now say.
    • “Spurred by recent research, sleep scientists and doctors are rethinking the conventional wisdom. In some cases, they are backing away from dogmatic approaches such as cutting out screens two hours before bedtime. And they are questioning how much the dreaded “blue light” actually delays sleep.
    • “It is becoming more evident that the tech in and of itself isn’t always the problem,” says Shelby Harris, a clinical psychologist specializing in behavioral sleep medicine in New York. “We need to figure out how to tailor the recommendations to the person.”
  • Mercer Consulting discusses “Help for opioid addiction: Some progress, much more to do.” 

From the U.S. healthcare business front,

  • Beckers Payer Issues shares the views of 32 payer executives about changes to healthcare delivery in the next ten years. For example,
    • Bruce Rogen, MD. Chief Medical Officer of Cleveland Clinic Employee Health Plan: Longitudinal patient records on each patient accessible by providers caring for the patient having a complete history of clinical data sourced from multiple EMRs and across payers and over time going back years if not decades.
    • AI platforms that are able to access the longitudinal patient record to engage the patient in preventive care, filling gaps in care, managing medication refills, enhancing medication compliance, and obtaining prior authorization from payers when indicated.
    • Teams of healthcare providers using the longitudinal patient record and the AI platforms to provide care anywhere and everywhere (hospital, post-acute, home care, remote, virtual) and focusing on prevention. The team includes physicians, nurses, navigators, care coordinators, pharmacists, social workers, behavioral health psychologists and counselors, community healthcare workers and home care workers.
    • Ilan Shapiro, MD. Chief Health Correspondent, Medical Affairs Officer and Senior Vice President at AltaMed (Los Angeles): In 10 years, healthcare delivery will likely be more patient-centric and value-based, with AI technology playing a crucial role in both treatment and prevention of illnesses. Patients will be incentivized for proactive wellness steps, fostering a culture of health promotion. Nationwide care coordination will be streamlined, reducing constraints and enhancing accessibility. This transformation will empower patients and healthcare teams, ensuring that care is brought back to the community level.
  • Per FierceHealthcare
    • “Well-being programs continue to be a central focus for employers, and they’re evolving the reach of these offerings into new areas such as the social determinants of health, according to a new survey.
    • “The Business Group on Health and Fidelity Investments released their annual look at employers’ strategies around wellness on Wednesday, and found nearly all of the 160 surveyed firms said they view well-being programs as a being key to their overall strategy. These employers said they intend to continue funding these programs at current levels.
    • “In addition, more than half (51%) said they plan to build out their well-being programs to tackle social needs in the next three to five years.”
  • The Wall Street Journal examines the connection between private equity investments and growing healthcare costs.
    • “Consolidation is as American as apple pie.
    • “When a business gets bigger, it forces mom-and-pop players out of the market, but it can boost profits and bring down costs, too. Think about the pros and cons of Walmart and “Every Day Low Prices.” In a complex, multitrillion-dollar system like America’s healthcare market, though, that principle has turned into a harmful arms race that has helped drive prices increasingly higher without improving care. 
    • “Years of dealmaking has led to sprawling hospital systems, vertically integrated health insurance companies, and highly concentrated private equity-owned practices resulting in diminished competition and even the closure of vital health facilities. As this three-part Heard on the Street series will show, the rich rewards and lax oversight ultimately create pain for both patients and the doctors who treat them. Belatedly, state and federal regulators and lawmakers are zeroing in on consolidation, creating uncertainty for the investors who have long profited from the healthcare merger boom.”
  • STAT News considers the lack of consensus over the meaning of value-based care. Sigh.
    • “Mai Pham, president of the Institute for Exceptional Care, said her benchmark for success is not how health care providers are feeling. It’s what is actually happening to the nation’s health, and the status quo in her view is unacceptable. Life expectancy among Americans has plateaued, and life expectancy for Americans in the prime years of their lives is falling. This trend, Pham noted, started before the Covid-19 pandemic, and it’s happening across races and geography.
    • “It’s difficult to say whether value-based care has been a success. Medicare has tried a broad range of programs and strategies, each of which has involved a broad range of organizations. Some have done well, others have not.
    • “So it’s not a binary answer,” Pham said. “What I would say is that it has not lived up to the hype.”
  • mHealth Intelligence tells us,
    • “Though telehealth use skyrocketed among United States adults with private health insurance during the COVID-19 pandemic, new research reveals that rural residents utilized telehealth less than their urban peers.
    • “The research, published by the AARP Public Policy Institute last week, examined changes in telehealth use from 2019 to 2021 among people younger than 65 enrolled in private, employer-sponsored health insurance plans.”

Midweek Update

David Ermer–CDC, Congress, COVID-19 vaccine, Generative AI, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • The New York Times reports,
    • “The chairmen of two Senate committees overseeing health policy, concerned about companies “padding their own profits” at the expense of patients, are looking into the practices of a data analytics firm that works with big insurers to cut payments to medical providers.
    • “The firm, MultiPlan, recommends what it says are fair payments for medical care, but the firm and the insurers can collect higher fees when payouts are lower. This business model could “result in an improper conflict of interest,” the chairmen of the two committees, Ron Wyden of Oregon and Bernie Sanders of Vermont, wrote in a letter to the firm’s chief executive that was released on Tuesday.
    • “The senators called on MultiPlan to meet with the committees’ staffs to discuss an investigation last month by The New York Times that found the firm’s pricing tools could leave patients with unexpectedly large bills when they see doctors outside their health plans’ networks.”
  • Govexec tells us,
    • “The Office of Personnel Management last week gave agencies a reminder that as campaign season approaches, officials should be vigilant against efforts to “burrow” political appointees into career positions in the federal government’s competitive and Senior Executive services.
    • “In a memo to agency heads, OPM’s associate director for merit system accountability and compliance Mark Lambert and associate director for workforce policy and innovation Veronica Hinton addressed the controversial practice, which is legal, albeit with a strict set of regulations to ensure political appointees are qualified for career roles they’re lined up for.”
  • KFF introduced,
    • “A new KFF resource—Health Policy 101—explains the basics on a wide range of topics about health programs and policy in the United States, such as Medicare and Medicaid, the Affordable Care Act, health care costs and affordability, women’s health issues, and the politics of health care. Health Policy 101 chapters are available online and can be downloaded in PDF format. The “101” was created to serve as a mini “textbook” for faculty and students interested in health policy. Dr. Drew Altman, KFF’s president and CEO, is the editor of the 101 series.”

From the public health and medical research front,

  • MedPage Today informs us,
    • “The updated monovalent XBB.1.5 COVID-19 vaccines were effective against Omicron subvariants circulating during the most recent respiratory virus season, but their effectiveness waned over time, according to a brief report.
    • “The three vaccines updated to target the SARS-CoV-2 XBB.1.5 subvariant — Moderna’s and Pfizer-BioNTech’s mRNA vaccines and the Novavax vaccine — were 66.8% effective against hospitalization at 4 weeks, decreasing to 57.1% after 10 weeks, wrote Dan-Yu Lin, PhD, of the UNC Gillings School of Global Public Health in Chapel Hill, North Carolina, and colleagues.
    • “Vaccine effectiveness against infection was about 52% after 4 weeks, decreasing to 33% after 10 weeks, and to 20% after 20 weeks, the New England Journal of Medicineopens in a new tab or window correspondence showed.
    • “We expected these vaccines to be effective, especially against hospitalization and death. We also expected the effectiveness to decline over time,” Lin told MedPage Today. “However, we didn’t know beforehand the levels of effectiveness or the duration of protection.”
  • The Wall Street Journal shares the view of readers who have used GLP-1 drugs.
    • “Hundreds of readers responded in the comments space and by email to Bradley Olson’s essay about his experience using a GLP-1 drug for weight loss. Readers shared stories about their own attempts to lose weight, journeys that often took place over the course of decades and included nonmedicinal strategies before the advent of GLP-1 drugs. Our readers made overwhelmingly positive comments about the medications, and in general found that the transformational impact of the GLP-1 drugs made such difficulties as getting prescriptions filled and side effects bearable. Some readers who have struggled to lose weight wrote that they found inspiration in Olson’s essay to consider trying a medical solution.” 
  • Per BioPharma Dive,
    • “A new kind of antidepressant eased symptoms and improved sleep among adults enrolled in a large Phase 3 trial, Johnson & Johnson, the drug’s developer, said Wednesday.
    • “J&J is studying the drug, called seltorexant, as an “adjunctive” therapy to background treatment with other antidepressants like SSRIs. The company’s trial enrolled adults with major depressive disorder as well as insomnia, which often accompanies depression and isn’t well treated by SSRIs.
    • “J&J didn’t disclose detailed data in its Wednesday statement. But the company did share the trial met all of its primary and secondary goals, noting the improvement in depressive symptoms among seltorexant-treated participants at study day 43 was both statistically significant and clinically meaningful.”
  • The New York Times dives into recent research on the sense of taste.
    • “The perception of taste is a remarkably complex process, starting from that first encounter with the tongue. Taste cells have a variety of sensors that signal the brain when they encounter nutrients or toxins. For some tastes, tiny pores in cell membranes let taste chemicals in.
    • “Such taste receptors aren’t limited to the tongue; they are also found in the gastrointestinal tract, liver, pancreas, fat cells, brain, muscle cells, thyroid and lungs. We don’t generally think of these organs as tasting anything, but they use the receptors to pick up the presence of various molecules and metabolize them, said Diego Bohórquez, a self-described gut-brain neuroscientist at Duke University. For example, when the gut notices sugar in food, it tells the brain to alert other organs to get ready for digestion.”
  • Healio lets us know,
    • “Women who get an epidural during delivery appear to have a marked reduction in serious complications the first few weeks after giving birth, a new study shows.
    • “A painkilling epidural can reduce risk by 35% in women for complications like heart attack, heart failure, blood infection and hysterectomy that can occur as a result of delivery, researchers reported May 22 in the BMJ.
    • “And the risk declines even more for women with known risk factors for these complications such as obesity, other health problems or prior delivery, researchers said.
    • “For those women, an epidural can reduce their risk of complications by 50%, compared to a 33% risk reduction in those without such factors.
    • “And women delivering preterm had a risk reduction of 47%, results show.”
  • and
    • “Researchers found that a questionnaire successfully identified patients with STIs who can be safely evaluated for penicillin allergy by skin test or by a two-step graded oral challenge, according to a study.
    • “Providers caring for clients with STIs are often faced with clients reporting a history of penicillin allergy (up to 15% of clients). Penicillin remains the drug of choice for the treatment of all stages of syphilis,” Rebecca A. Lillis, MD, associate professor at the Louisiana State University School of Medicine, told Healio.
    • “Ceftriaxone is the drug of choice for treatment of gonorrhea and often avoided in clients who report a penicillin allergy, resulting in suboptimal care,” she said.”
  • The National Institutes of Health announced,
    • “A team of researchers funded by the National Institutes of Health have generated the first complete chromosome sequences from non-human primates. Published in Nature(link is external), these sequences uncover remarkable variation between the Y chromosomes of different species, showing rapid evolution, in addition to revealing previously unstudied regions of great ape genomes. Since these primate species are the closest living relatives to humans, the new sequences can provide insights into human evolution.”

From the U.S. Healthcare business front,

  • Per Fierce Healthcare,
    • “A significant gap exists between health plans that have the highest consumer experience scores and those with the lowest, according to a new survey from J.D. Power.
    • “The consumer insights firm released its annual look at commercial health plans and found that overall satisfaction lands at a score of 595 out of 1,000 points, an increase of three points from 2023’s survey. However, the analysts found a 79-point gap between plans with the highest and lowest scores.
    • “Further, plans with the best consumer satisfaction ratings are getting better, while the lowest-performing plans are sliding. Scores at the highest performers increased by 20 points, while lower scores declined by eight points.
    • “In many cases, employer-sponsored health insurance is consumers’ primary window into the healthcare system,” said Christopher Lis, Ph.D., managing director of global healthcare intelligence at J.D. Power, in a press release. “Access to care, cost of care, chronic condition management—the central pillars of the consumer healthcare experience—are all heavily influenced by commercial health plans.”
  • and
    • “The proportion of hospitals meeting the Office of the National Coordinator for Health IT’s (ONC’s) bar for interoperability rose substantially from 2018 to 2023, though a focus on day-to-date data exchange will be necessary to fill some remaining gaps.
    • “According to a recent data brief from ONC, 7 in 10 nonfederal acute care hospitals reported either “routinely” or “sometimes” engaging in all four measured domains of electronic health information interoperability: sending data (92%), receiving data (87%), querying data from outside their organization (84%) and integrating outside data into their records without manual entry (78%).
    • “The 70% top line is an improvement from the 23% of 2014 and the 46% of 2018. Interoperability remained flat at 70% from 2022 to 2023, though the ONC noted that its surveys for the two years were fielded nearly back-to-back to catch up following pandemic polling delays.”
  • Beckers Payer Issues points out,
    • “UnitedHealth Group is running around 500 use-case applications for AI across the organization, CEO Andrew Witty told investors. 
    • “Speaking at a conference on May 29, Mr. Witty said some of the company’s AI efforts are “low-hanging” opportunities aimed at speeding up administrative processes. 
    • “It’s not Einstein opportunities,” he said. “These are relatively straightforward. Some of them are already underway. They play out in areas like speed, allowing call handlers to deal with issues faster than they used to.” 
    • “Heather Cianfrocco, CEO of Optum, told investors Optum’s AI efforts are focused in two areas. 
    • “One is administrative support, particularly for clinicians, giving clinicians time back at home or in the office,” Ms. Cianfrocco said. “The second area I would highlight is identifying disease progression, or emerging disease, faster.” 

 

Tuesday Tidbits

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

From Washington, DC

  • FedWeek informs us that
    • “Congress has started to craft the appropriations bills and the annual DoD authorization bill, the key measures for decisions on the upcoming year’s federal employee raise and on workplace policy changes.
    • “While it’s generally expected that none of those measures will be enacted into law before the elections — when Congress returns next week from its current recess, it will have only nine scheduled working weeks before November — the measures for the meantime will serve to stake out positions. * * *
    • “The primary bill affecting federal workplace policies, the financial services-general government measure, is set for voting next week at the subcommittee level and the following week for at the committee level.”
  • Federal News Network tells us,
    • “The Office of Personnel Management is working to address a spike in fraudulent activity on hundreds of accounts in a flexible spending account (FSA) program for federal employees.
    • “Several hundred federal employees currently enrolled in FSAFEDS have experienced recent fraudulent activity on their accounts. Scammers have used the employees’ personal information to either create new, fraudulent FSAs, or otherwise make fraudulent reimbursement claims on existing FSAs. * * *
    • “The fraudulent activity in FSAFEDS is relatively limited in scope, since it’s affecting just a few hundred federal employees’ accounts. In total, the scammers have managed to shore up a couple hundred thousand dollars, Politico first reported last week.
    • “Since becoming aware of the fraud, HealthEquity has already taken additional security measures by implementing Login.gov requirements and setting up dual-factor authentication for federal employees to be able to log in to their FSAFEDS accounts. * * *
    • “Agency benefits officers and payroll providers are advising federal employees who use FSAFEDS to review and verify their leave, earnings, and FSA account statements. If employees notice any suspicious charges or activity, they can call FSAFEDS at 877-372-3337.”
  • The Congressional Research Service posted a Legal Sidebar titled “HHS Finalizes Rule Addressing Section 1557 of the ACA’s Incorporation of Title IX” of the Education Amendments of 1972.
  • Newfront reminds us,
    • “IRS Notice 2023-70 adjusts the Patient-Centered Outcomes Research Institute (PCORI) fee to $3.22 per covered individual for health plan years ending on or after October 1, 2023 and before October 1, 2024, which includes 2023 calendar plan years. This represents a $0.22 per covered individual increase from last year’s PCORI fee (from $3.00).
    • “The annual PCORI fee must be reported and paid to the IRS by July 31, 2024, via the second quarter Form 720.”
  • The American Hospital Association News reports,
    • “A coalition of 230 national associations, including the AHA, submitted a letter the week of May 20 to the Federal Trade Commission requesting a stay on the Sept. 4 effective date of the Non-Compete Clause Final Rule to allow for judicial review.
    • “Under Section 705 of the Administrative Procedure Act, agencies ‘may postpone the effective date of action taken by it, pending judicial review’ when ‘justice so requires,'” the letter notes. “We strongly encourage you to exercise this power on the Noncompete Rule as FTC and other agencies recently have on other rulemakings.”
    • “The organizations said a lack of FTC guidance on key pieces of the rule, such as what it means to be in a policymaking position or how the FTC will apply its functional test, has created substantial uncertainty for businesses and employees nationwide. The final rule is currently being challenged in court by several parties, including the U.S. Chamber of Commerce. A decision is expected this summer.”
  • Mercer Consulting discusses how Part D enhancements for 2025 may impact Part D creditable coverage reporting, an OPM requirement for FEHB carriers.
    • “One of the outstanding questions that was addressed by CMS guidance is what the standard Part D coverage actuarial value will be for testing creditable coverage. Helpfully, CMS guidance provided that “discounts paid by manufactures are not included in the [Part D] plan paid amount when making a determination about creditable coverage.”
    • “This helpful clarification confirmed Mercer’s original interpretation that while it may be somewhat harder for some group health plans to pass creditable coverage testing, the passing threshold is not as drastic of an increase as many initial outside reports originally suggested.
    • “In addition, CMS clarified that it will continue to permit use of its 2009 creditable coverage simplified determination methodology, without modification to the existing parameters, for 2025 for group health plan sponsors not applying for the retiree drug subsidy. CMS will re-evaluate the continued use of the existing simplified determination methodology, or establish a revised one, for 2026 in future guidance.”

From the public health and medical research front,

  • The National Institutes of Health lets us know,
    • “Feeding children peanut products regularly from infancy to age 5 years reduced the rate of peanut allergy in adolescence by 71%, even when the children ate or avoided peanut products as desired for many years. These new findings, from a study sponsored and co-funded by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID), provide conclusive evidence that achieving long-term prevention of peanut allergy is possible through early allergen consumption. The results were published today in the journal NEJM Evidence.
    • “Today’s findings should reinforce parents’ and caregivers’ confidence that feeding their young children peanut products beginning in infancy according to established guidelines can provide lasting protection from peanut allergy,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H. “If widely implemented, this safe, simple strategy could prevent tens of thousands of cases of peanut allergy among the 3.6 million children born in the United States each year.”
    • “The new research findings come from the LEAP-Trio study, which builds on the seminal results of the Learning Early About Peanut Allergy (LEAP) clinical trial and the subsequent LEAP-On study, both sponsored and co-funded by NIAID.”
  • The HHS OIG issued a report on the inclusiveness of NIH-funded studies.
    • “What OIG Found
      • Two-thirds of the clinical trials in our sample had inclusive enrollment plans, but one-third did not plan to include all racial and ethnic groups.
      • Slightly more than half of clinical trials in our sample were missing required information that would explain the planned target population.
      • Most completed clinical trials in our sample missed planned enrollment targets for underrepresented groups.
      • NIH monitors clinical trial enrollment but has had limited success spurring improvement.
    • W”hat OIG Recommends
      • Hold researchers accountable for clearly describing the rationale for planned study population, as required by NIH policy.
      • Develop additional ways of supporting researchers in meeting inclusion enrollment targets.
      • Promptly take steps to align NIH’s demographic data collection and reporting with the revised OMB requirements and obtain more precise clinical trial inclusion enrollment data.
    • “NIH concurred with the three recommendations.”
  • STAT News reports “Heat waves associated with increased risk of preterm birth in the U.S.”
    • “A new investigation, published on Friday in JAMA Network Open, confirmed the link to early deliveries at a massive scale, in a large cohort study capturing over half of the births that occurred in the United States between 1993 and 2017. Its results shed light on the way existing health inequities may be exacerbated by a worsening climate.
    • “The study looked at more than 53 million singleton births that occurred in the 50 most populous cities in the U.S. during the hottest months of the year. Looking back at heat waves between May and September, researchers counted preterm births (between 28 to 37 weeks of gestation) and early births (between 37 and 39 weeks) within four to seven days of the spike. During that period, there were 2.15 million preterm births, and 5.8 million early births.
    • “After a heat wave, which the study defined as four consecutive days in which the mean temperature was higher than the local 97.5th percentile, preterm births increased by 2%, and early births by 1%. But the distribution of these adverse outcomes was uneven: Mothers who were 29 or younger, had a lower level of education, and belonged to a minority ethnic or racial group saw a 4% increase in preterm births, and a 3% increase in early deliveries.”
  • Medscape seeks to untangle the complex relationship between obesity and cancer.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Merck & Co. is close to a $1.3 billion deal to buy Eyebiotech, a move that would push the big drugmaker into the large and growing market for eye-care. “Merck & Co. is close to a $1.3 billion deal to buy Eyebiotech, a move that would push the big drugmaker into the large and growing market for eye-care. 
    • “Under the terms, Merck would pay the $1.3 billion in cash upfront to acquire the closely held biotech, according to people familiar with the matter. Merck could make an additional $1.7 billion in milestone payments for the company, which goes by the name EyeBio.
    • “The deal could be announced as early as Wednesday, the people said. Merck’s venture arm was an investor in EyeBio. 
    • “EyeBio’s lead drug, Restoret, is in development to treat eye conditions including a form of age-related macular degeneration that leads to blurred vision and potentially blindness. In older people with the disease, known as Wet AMD, a part of the retina wears down, and fluid leaks from blood vessels.” 
  • and
    • “Cancer Is Capsizing Americans’ Finances. ‘I Was Losing Everything.’
    • “Higher drug prices, rising out-of-pocket costs and reduced incomes create economic strain for many patients.”
  • Per BioPharma Dive,
    • “Johnson & Johnson is adding to its portfolio of dual-targeting antibody drugs, announcing on Tuesday a deal to acquire an experimental skin disease medicine for $1.25 billion.
    • “Per deal terms, J&J will buy Yellow Jersey Therapeutics, a spinout newly created by the drug’s developer, Swiss biotechnology startup Numab Therapeutics. The acquisition hands J&J a drug known as NM26 that’s ready for Phase 2 testing in atopic dermatitis, a form of eczema.
    • “In a statement, J&J said NM26 has the potential to offer “distinctive benefits” versus existing treatments for atopic dermatitis, which include Sanofi and Regeneron’s Dupixent and AbbVie’s Rinvoq. The drug targets two proteins, IL-4Ra and IL-31, that are linked to inflammatory diseases.”
  • STAT News relates,
    • “An experimental drug from Insmed Incorporated successfully reduced lung problems among patients with an airway disease in a closely watched Phase 3 trial, sending the company’s share price soaring early Tuesday. 
    • “The drug, brensocatib, reduced so-called pulmonary exacerbations by roughly 20% versus placebo in patients with bronchiectasis, hitting the trial’s primary endpoint. The trial, called the ASPEN study, tested two dosages of the drug, and the company said both significantly cut rates of pulmonary exacerbations.” 
  • Beckers Hospital Review notes,
    • “Novo Nordisk is contesting Sen. Bernie Sanders’ calls to reduce the list prices of Ozempic and Wegovy in the U.S., Bloomberg reports.  
    • “In late April, the Senate Health, Education, Labor, and Pensions Committee, chaired by Mr. Sanders, launched an investigation into Novo Nordisk’s list pricing for GLP-1 drugs. This followed research showing that Ozempic could be manufactured for less than $5 per month, significantly lower than the U.S. list price of nearly $1,000 for a monthly supply.
    • “Mr. Sanders requested information from Denmark-based Novo Nordisk by May 8, but the drugmaker requested an extension to submit its responses. 
    • “In a letter issued to Mr. Sanders May 24, Novo Nordisk said it is prepared to work with lawmakers to address “systemic issues so that everyone who can benefit from its medicines is able to get them,” but argued that focus on its list prices for the drugs is misplaced since it retains about 60% of the list price of Ozempic and Wegovy in the U.S. after rebates and fees are paid to middlemen, Bloomberg reports. 
    • “Novo Nordisk also said that focusing on the cost disparity is unfair because the development of the GLP-1 drugs required billions in upfront investment. The drugmaker said it spent over $10 billion to develop the GLP-1 medicines and that, “under current market conditions, the company expects that net prices will continue to decline for both Ozempic and Wegovy,” Bloomberg reports.”
  • and
    • “Johns Hopkins University Bloomberg Center recently awarded a team of researchers $300,000 to aid them in a “first-of-its-kind” drug supply chain dashboard. 
    • “On May 21, the Washington, D.C.-based college announced $15 million in funding for 40 projects. One of the winning projects is “The Johns Hopkins Drug Supply Chain Data Dashboard: Improving Data Transparency and Increasing Resiliency in the U.S. Pharmaceutical Supply Chain.”
    • “The dashboard “will provide timely insights to tackle drug shortages and supply chain disruptions,” according to Tinglong Dai, PhD, a Johns Hopkins professor of operations management and business analytics who is part of the research team.”
  • HR Dive points out that the recent Fair Labor Standards Act overtime rule changes effective on July 1, 2024. HR Dive shares some its articles about this rule.