Thursday Miscellany

Medical / Rx research

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.

Tuesday Tidbits

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

From Washington, DC

  • Chief Healthcare Executive lets us know,
    • Telehealth advocates have said this year represents the Super Bowl for virtual healthcare, and the game is about at halftime.
    • On the upside, telehealth leaders remain confident that Congress will approve legislation that would allow health systems and providers to continue offering virtual care and hospital-at-home programs.
    • But lawmakers may not act until late in the fourth quarter [in other words, the expected lame duck session following the November’s national election].
  • Roll Call informs us,
    • “The Supreme Court will decide a dispute about hospital reimbursement rates under Medicare, with hundreds of hospitals arguing the government had shorted them for treating low-income patients.
    • More than 200 hospitals in more than 30 states, led by Advocate Christ Medical Center in Illinois, have asked the justices to overturn a lower court ruling that allows the Department of Health and Human Services to reimburse a lower rate for treating a high proportion of low-income patients. The dispute, which the hospitals said could affect more than $4 billion in federal funds, hinges on how to determine which patients count toward that reimbursement rate and follows a 2022 Supreme Court decision over the same program.
    • The justices announced Monday that they would decide the case, which means oral arguments and a decision would come in the next term that starts in October.
  • Federal News Network tells us,
    • “The Chief Human Capital Officers (CHCO) Council has a new face taking the lead to collaborate on human capital initiatives and strategies across government.”
    • “Colleen Heller-Stein, formerly deputy CHCO at the Treasury Department, has stepped in as executive director of the CHCO Council, Federal News Network has learned. The senior-level position within the Office of Personnel Management leads agency CHCOs and other human capital leaders to innovate on best practices for managing the recruitment and retention of the federal workforce.
    • “Heller-Stein is the first career federal executive to serve in the CHCO Council leadership role. She took over the position a few weeks ago from Latonia Page, who had been working as acting executive director of the CHCO Council since September 2023. Prior to Page’s time on the job, Margot Conrad — currently deputy chief of staff at OPM — served as the council’s executive director for about two and a half years.”‘

From the public health and medical research front,

  • KFF expresses concern about the general unavailability of bird flu tests.
    • “A recent rule that gives the FDA more oversight of lab-developed tests may bog down authorization. In a statement to KFF Health News, the FDA said that, for now, it may allow tests to proceed without a full approval process. The CDC did not respond to requests for comment.”
    • “But the American Clinical Laboratory Association has asked the FDA and the CDC for clarity on the new rule. “It’s slowing things down because it’s adding to the confusion about what is allowable,” said Susan Van Meter, president of the diagnostic laboratory trade group.
    • “Labcorp, Quest Diagnostics, and other major testing companies are in the best position to manage a surge in testing demand because they can process hundreds per day, rather than dozens. But that would require adapting testing processes for their specialized equipment, a process that consumes time and money, said Matthew Binnicker, director of clinical virology at the Mayo Clinic.
    • “There’s only been a handful of H5N1 cases in humans the last few years,” he said, “so it’s hard for them to invest millions when we don’t know the future.”
  • The Wall Street Journal offers guidance on how people can improve the deathbed experiences of loved ones.
  • Beckers Hospital Review points out,
    • “Baltimore-based Johns Hopkins School of Nursing is addressing community needs by taking primary care door to door, NPR reported June 11.
    • “The Neighborhood Nursing pilot program consists of a team of nurses and community health workers that make weekly visits to three apartment buildings in Johnston Square, a predominantly Black disadvantaged neighborhood. The visits are free to patients and are not dependent on health status, income or what type of insurance, if any, they have. Visits are done in people’s homes, senior centers, lobbies, libraries and anywhere else people can be found. 
    • “In the time it has run, Neighborhood Nursing has successfully helped patients receive care and has expedited physicians’ appointments as needed. However, the greatest challenge is funding.”
  • Per Healio,
    • “From 2010 to 2021, most high and moderate risk factors for preeclampsia increased in the U.S.
    • “Multifetal gestation and nulliparity were the only preeclampsia risk factors to decrease during this period.”
  • Per BioPharma Dive,
    • “Pharmaceutical companies employ many different strategies when building their cancer drug pipelines, but one recent commonality among them is a belief in the future of targeted therapies known as antibody-drug conjugates.
    • “Many of the leading cancer drugmakers have at least one or two antibody-drug conjugates, or ADCs, in development. Others, such as Pfizer, Johnson & Johnson and Merck & Co., have used buyouts or partnerships to build an ADC portfolio.
    • “One of the best-selling ADCs on the market is AstraZeneca and Daiichi Sankyo’s Enhertu, which brought in combined sales of $2.5 billion in 2023, almost double the year before. The two companies formed a $7 billion alliance around Enhertu in 2019 and since then, the drug has secured multiple approvals and changed the way some breast cancers are treated.
    • “Over that time, AstraZeneca has made ADCs a more substantial part of its overall pipeline alongside radiopharmaceuticals and immunotherapies, giving the company many potential combinations to work with, said Carlos Doti, vice president and head of medical affairs for its U.S. oncology division.”

From the U.S. healthcare business front,

  • Beckers Payer Issues notes,
    • “CMS must recalculate the Medicare Advantage star ratings for Anthem Blue Cross Blue Shield of Georgia, a federal judge ruled June 10. 
    • “The judge ruled partially in favor of Elevance Health, which sued to challenge CMS’ star ratings methodology in December. The insurer sought new ratings for several of its subsidiaries, but the judge ruled CMS needs to recalculate ratings only for BCBS of Georgia. 
    • “Elevance’s challenge focused on CMS’ use of the Tukey method, a change announced by CMS in a 2020 final rule and implemented in 2024 star ratings. The method removes extreme outliers from measure scores to prevent outliers from affecting all MA contracts, making it more difficult for plans to earn a high star rating. In 2022, a final star ratings rule from CMS did not mention the new change, which the agency added back in the 2023 rule, citing an inadvertent removal. 
    • “CMS also limits scoring changes to 5% annually. In the lawsuit, Elevance said CMS should have factored in those limits before adding the Tukey change back in 2023 versus the other way around.
    • “Randolph Moss, a judge for the U.S. District Court in Washington, D.C, ruled CMS violated the Administrative Procedure Act in applying the Tukey methodology. However, Mr. Moss ruled Elevance proved the Tukey method affected the star rating only for BCBS of Georgia and not the other plans for which it sought revised ratings.” 
  • This opinion and last week’s Scan Health opinion may wind up before the U.S. Court of Appeals for the D.C. Circuit.
  • Per Healthcare Dive,
    • “Just three days before bankrupt Steward Health Care was set to run out of funds, the health system said it’s struck a deal to capture $225 million of additional debtor-in-possession financing to keep its operations afloat during Chapter 11 proceedings.
    • “The funds come from Steward’s FILO lenders, which include private credit lenders Sound Point Capital and Brigade Agency Services, as well as Chamberlain Commercial Funding, according to a press release shared with Healthcare Dive. 
    • “Steward will present the deal — which the system says is sufficient to finance operations prior to its July asset sales — for approval in bankruptcy court later this week.”
  • According to BioPharma Dive,
    • “Approval of Eli Lilly’s experimental Alzheimer’s disease drug donanemab would help drive sales of Eisai and Biogen’s rival medicine Leqembi, analysts wrote after a Food and Drug Administration panel on Monday supported clearance of donanemab.
    • “A rising tide lifts all boats, in our view,” wrote Myles Minter, an analyst at William Blair, in a client note. Donanemab works similarly to Leqembi by eliminating from the brain a toxic protein called amyloid that scientists see as linked to Alzheimer’s progression.”
  • McKinsey & Co. discusses the ongoing digital transformation in healthcare.
  • The International Foundation of Employee Benefit Plans shares useful insights on the final rules amending the Fair Labor Standards Act that take effect on July 1.

Monday Roundup

David Ermer–FDA, Medical / Rx research, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “Big tobacco companies and their critics agree on at least one thing: The illegal, fruit-flavored, disposable vapes that are popular among teenagers have flooded the U.S. market and federal regulators haven’t done enough to stop it.
    • “The Food and Drug Administration and Justice Department said Monday they are stepping up enforcement by forming a multiagency task force to go after the illegal distribution and sale of e-cigarettes.
    • “Disposable vaping devices, almost none of which are authorized for sale by the FDA, represent more than 30% of U.S. e-cigarette sales in stores tracked by Nielsen, according to an analysis by Goldman Sachs. Many of them are imported from China. Breeze Pro and Elfbar, both of which were ordered off the market last year by the FDA, remain the top two disposable e-cigarette brands in the U.S.”
  • Per BioPharma Dive,
    • “An experimental and closely watched medicine for Alzheimer’s disease is one step closer to approval, after receiving support from a panel of experts who advise the Food and Drug Administration. “An experimental and closely watched medicine for Alzheimer’s disease is one step closer to approval, after receiving support from a panel of experts who advise the Food and Drug Administration.
    • “On Monday, the panel unanimously voted that the medicine, developed by Eli Lilly and known as donanemab, appears to be an effective treatment for certain Alzheimer’s patients. The experts also concluded, by an 11-0 vote, that the drug’s benefits outweigh its risks, despite some safety concerns.
    • “I thought the evidence is very strong and the trials [show] the effectiveness of the drug,” said Dean Follman, a panelist and assistant director of biostatistics at the National Institute of Allergy and Infectious Diseases.”
  • Federal News Network tells us,
    • “Postmaster General Louis DeJoy is billing the Postal Service’s survival from the worst days of the COVID-19 pandemic as an unsung comeback story — but the agency is still writing its next chapter, as it figures out how to stay financially healthy in the long term.
    • “DeJoy, speaking Monday at the National Postal Forum in Indianapolis, said he inherited a “broken business model” when he took office in June 2020 — and that the agency was months away from running out of cash at the height of the COVID-19 pandemic.
    • “Failure to adequately adapt to social, economic, technological, and industrial changes have destroyed giants in their industry – Kodak, Motorola, Blockbuster – in just a few short years,” DeJoy said in his keynote address. “The demands of the changes experienced by the Postal Service were magnitudes greater. In addition, these organizations did not have a Congress or a regulator to contend with.”
    • “Four years into his tenure as postmaster general, DeJoy is defending USPS changes under this 10-year reform plan — some elements of which USPS is temporarily pausing, after bipartisan scrutiny from Congress.”

From the public health and medical research front,

  • BioPharma Dive lets us know,
    • “Moderna on Monday said a combination flu and COVID-19 shot it’s developing met the goal of a late-stage study, eliciting higher immune responses to the two viruses than did available vaccines when tested among adults 50 years or older.
    • “Dubbed mRNA-1083, the shot is made up of Moderna’s second-generation COVID vaccine and a candidate for influenza, which have each been tested on their own in separate trials. The company pit mRNA-1803 against Spikevax, its approved COVID vaccine, and against flu shots from drugmakers Sanofi and GSK.
    • “Moderna said the data showed a single dose of mRNA-1083 was statistically equivalent, or “non-inferior,” to giving those vaccines together. It plans to present full results at an upcoming medical meeting, and to discuss next steps with regulators.”
  • STAT News reports,
    • “It’s a familiar scene for patients during a routine primary care visit. The doctor scans blood test results, notes high cholesterol flagged by a standard calculator to assess risk of heart attack or stroke, then decides — and ideally discusses — whether to recommend taking a statin to cut the risk over time.
    • “That conversation may happen less often if changes in the risk model presented by the American Heart Association in November translate into new guidelines for prescribing statins. Those guidelines haven’t been recalibrated yet, but a new analysis suggests that the new risk model could mean far fewer Americans — as many as 40% less than current calculators say — would be candidates for cholesterol-lowering drugs to prevent cardiovascular disease.”
  • NBC News informs us,
    • “New research points to a better way to measure obesity than body mass index.” New research points to a better way to measure obesity than body mass index.
    • “Body mass index was first developed in 1832 and has been the standard way to estimate a person’s body fat since the 1980s. The calculation, however, has come under increasing scrutiny in recent years.
    • “One major critique of BMI is that it doesn’t look at how much of a person’s weight is fat, and where fat is distributed around the body. It also doesn’t take into account the other elements that make up a person’s body composition beyond fat, including muscle, bone, water and organs.
    • “Fat distribution and body composition can vary dramatically among different people with the same BMI,” Wenquan Niu, a professor at the Capital Institute of Pediatrics in Beijing, wrote in an email.
    • “Because muscle is much denser than fat, BMI skews higher in people who are very muscular but have less body fat, like athletes, Niu said. On the other end of the spectrum, BMI can be underestimated in older people with much less muscle mass and more body fat.
    • ‘In a study published last week in JAMA Network Open, Niu and his colleagues showed that a different measurement, called the body roundness index, is a more precise way to estimate obesity.”
    • While BMI estimates a person’s body fat using just two measurements, height and weight, BRI also incorporates hip and waist circumferences to estimate how much total fat and visceral fat someone has. Visceral fat is a type of deep belly fat that surrounds the organs and can be more harmful to health.
  • Medscape offers an update on new oral weight loss drugs and tells us,
    • Fewer than one in five people eligible for lung cancer screening reported being up to date with screening in 2022, though patient navigation added to usual care could be a way of increasing these rates, according to two studies published in JAMA Internal Medicine.
    • Among nearly 26,000 respondents in a nationwide cross-sectional study, the overall prevalence of up-to-date lung cancer screening was 18.1% but varied across states (range 9.7% to 31%), with relatively lower rates in Southern states that have a high lung cancer mortality burden, noted Priti Bandi, PhD, of the American Cancer Society, and colleagues.

From the U.S. healthcare business front,

  • The Altarum Institutes posted a report titled “Utilization and Price Drivers of Increasing Health Care Spending (2010-2023).”
    • “Following the 2022 slowdown in health care spending that led to the overall health care sector reaching its smallest share of the economy since 2014 (17.3%), there has been a gradual resurgence in health care spending beginning in early 2023. This resurgence, driven predominantly by the greater use of care (and particularly a return of elective and outpatient services), is following the pandemic-affected period of very slow spending growth, postponed care, and health care labor shortages from 2020 through 2022. Higher utilization has been observed in data such as our monthly Altarum health care spending and prices briefs, as well as other industry sources such as hospital and insurer financial reports. In this blog, we put 2023’s above-average health care utilization increases into perspective historically and break down utilization trends by the different major health care spending categories.
    • “Following the 2022 slowdown in health care spending that led to the overall health care sector reaching its smallest share of the economy since 2014 (17.3%), there has been a gradual resurgence in health care spending beginning in early 2023. This resurgence, driven predominantly by the greater use of care (and particularly a return of elective and outpatient services), is following the pandemic-affected period of very slow spending growth, postponed care, and health care labor shortages from 2020 through 2022. Higher utilization has been observed in data such as our monthly Altarum health care spending and prices briefs, as well as other industry sources such as hospital and insurer financial reports. In this blog, we put 2023’s above-average health care utilization increases into perspective historically and break down utilization trends by the different major health care spending categories.
    • Over the past fifteen years, rising U.S. health care spending has been driven both by increased utilization and higher prices, with utilization increases contributing more to higher spending (Figure 1). Since 2010, utilization of personal health care (spending on health goods and services, excluding spending on program administration, net cost of insurance, public health activities, and investment) has increased 47% (contributing about 60% of the overall spending growth), while underlying prices for care have increased 31%. Greater utilization since 2010 has been affected by increases in overall population rates of health insurance coverage, an aging population, greater direct government support for health care during the pandemic and increases in the intensity of care provided for many health care needs.” 
  • Per MedTech Dive,
    • “Abbott said Monday it will launch two over-the-counter continuous glucose monitors after receiving clearance from the Food and Drug Administration.” Abbott said Monday it will launch two over-the-counter continuous glucose monitors after receiving clearance from the Food and Drug Administration.
    • “One product is the company’s Lingo device, sold as a wellness product for people who do not have diabetes. The other is Abbott’s new Libre Rio device, which is intended for adults with Type 2 diabetes who do not use insulin, posing a direct challenge to Dexcom’s Stelo device. 
    • “After Lingo was cleared last week, RBC Capital Markets analyst Shagun Singh wrote the over-the-counter nod could offer a more than $1 billion sales opportunity for Abbott.”
  • Per Fierce Healthcare,
    • “Bobby Mukkamala, M.D., was voted in as president-elect of the American Medical Association (AMA) at the group’s annual meeting in Chicago. He will take over for immediate past president Jesse Ehrenfeld, M.D., whose last day in office is Tuesday, June 11. “Bobby Mukkamala, M.D., was voted in as president-elect of the American Medical Association (AMA) at the group’s annual meeting in Chicago. He will take over for immediate past president Jesse Ehrenfeld, M.D., whose last day in office is Tuesday, June 11. 
    • “Mukkamala will serve a one-year term for the physician advocacy group, which has been focused on reforming Medicare physician pay, reducing prior authorization burden and mitigating provider burnout, including through the use of technology to augment provider workflow. 
    • “Mukkamala is an otolaryngologist from Flint, Michigan, who has served in leadership roles within the American Medical Association and for local health initiatives in Michigan. He chairs the Substance Use and Pain Care Taskforce of the AMA and served on its board of trustees in 2017 and 2021.”
  • and
    • “Thought leaders from across the insurance industry will descend on Las Vegas this week for AHIP’s annual conference, kicking off three days of discussions on the biggest issues facing payers.”
    • “The Fierce Health Payer team will also be making the journey to Sin City, so keep an eye out for our coverage over the next several days. Ahead of the event, here’s a look at three key trends we expect to hear plenty about across panels, keynotes and meetings.”
      • GLP-1 Drug Costs and Shortages Remain Center-Stage
      • Continued Talk about Implementation of Value-Based Care, and
      • Cutting through the AI Hype.
  • Healthcare Dive adds,
    • “Teladoc Health has named a new CEO, months after the virtual care company’s long-term chief executive abruptly departed following flagging financial performance at the telehealth vendor.
    • “Charles “Chuck” Divita III will take on the role effective immediately, the company said Monday.
    • “His appointment comes about two months after Jason Gorevic, the former CEO who held the position since 2009, left the company.
    • “We are confident we have selected an innovative and visionary leader capable of delivering growth at scale, value for our clients and positive relationships with all our partners and colleagues,” David Snow Jr., chairman of Teladoc’s board of directors, said in a statement.
    • “Divita joins the virtual care company from GuideWell, a healthcare insurance and services company that includes Florida Blue, where he served as executive vice president of commercial markets and previously chief financial officer. He also worked as CFO at FPIC Insurance Group, which focuses on medical professional liability.”

Weekend Update

David Ermer–Congress, Medical / Rx research, OPM, SCOTUS, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Washington, DC,

  • The FEHBlog’s attention is drawn to this Committee hearing:
    • House Committee on Appropriations
    • June 12, 9:00 AM (EDT) | 2359 Rayburn House Office Building, Washington, D.C.
    • Markup: Fiscal Year 2025 State, Foreign Operations, and Related Programs and Homeland Security Bills
    • Meeting Details
  • MedPage Today reminds us about “the Top Supreme Court Health Cases to Watch [this month]. — A slew of cases this term could reshape health policy.” The Supreme Court now hands down its opinions on Thursdays.
  • Last week, the U.S. Office of Personnel Management’s (OPM) Office of Inspector General posted its Semi-annual report to Congress for the period ended March 31, 2024, and OPM posted its response to that report. These reports are always worth a gander.

From the public health and medical research front.

  • The American Medical Association offers “the top health tips your cardiologist wants you to know.”
  • Fortune Wells points out “five lifestyle changes improved brain function for those with early Alzheimer’s.”
  • NPR notes “eight mistakes to avoid if you’re going out in the heat.”
  • The Washington Post advises folks that “‘The first step before you take inventory of your body is to decide that you care about living a long, healthy life,’ one expert says.”

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “Doctors couldn’t help. [Parents and patients] turned to a shadow system of DIY medical tests.”Doctors couldn’t help. [Parents and patients] turned to a shadow system of DIY medical tests.
    • “Buoyed by regulatory vacuums, Silicon Valley is building a booming online wellness market that aims to leave the doctor’s office behind.
      • “Many investors and entrepreneurs endorse self-testing with similar urgency. Tiny Health founder Cheryl Sew Hoy said she raced to develop her baby microbiome testing start-up because of her experience giving birth to a C-section baby with gastrointestinal issues that doctors could not address. Though she and her business partners were aware that the benefits of gut bacteria testing have often been overhyped, they found cutting-edge research showing that the simplicity of a baby’s gut makes it highly responsive to interventions.
      • “To them, it did not seem fair to wait for years — possibly decades — until that research could become standard pediatric advice.
      • “It will eventually get to the point where you get screened with a stool test every time you go to the hospital, but that’s not going to happen next year or the next couple of years,” said Ruben Mars, a microbiologist at the Gut Microbiome Laboratory at the Mayo Clinic, and a scientific adviser to Tiny Health. “But these kids are getting chronic disease now. … They shouldn’t have to wait until it becomes standard of care.”
      • “As long as the medical system remains slow there is going to be a market for people who take matters into their own hands, said Anarghya Vardhana, a Silicon Valley investor. “If you don’t give patients the tools, they will go figure it out themselves,” she added.”

Friday Factoids

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplas

From Washington, DC,

  • The Washington Post reports
    • Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) this week wrote to eight pharmaceutical company CEOs, urging them to remove 130 patents from a key federal registry, according to letters shared with The Washington Post. The Democrats are targeting Novo Nordisk, including some of its patents related to expensive drug Ozempic; GlaxoSmithKline; and other companies that produce asthma and diabetes medications.
    • The 130 patents are among more than 300 patents that the Federal Trade Commission in April identified as “junk patent listings” that should be removed from the registry and are blocking competitors from producing cheaper alternatives. Monday is the deadline for the companies to remove the patents or reaffirm that they believe the patents are legal, according to a person who spoke on the condition of anonymity to detail the private enforcement process.
  • STAT News tells us,
    • “The Food and Drug Administration on Friday expanded the approval for GSK’s vaccine to protect against respiratory syncytial virus, or RSV, authorizing its use for at-risk adults as young as 50.”The Food and Drug Administration on Friday expanded the approval for GSK’s vaccine to protect against respiratory syncytial virus, or RSV, authorizing its use for at-risk adults as young as 50.
    • “Arexvy, which was the first RSV vaccine approved, now becomes the first to be available to adults under the age of 60 who are not pregnant. Prior to this FDA decision, Arexvy was licensed for use in people 60 and older.”
  • Tammy Flanagan writing in Govexec discusses the state of federal civil service retirement: CSRS and FERS.
  • Govexec adds,
    • “The government’s backlog of pending retirement claims from federal workers hit an eight-year low last month. “The government’s backlog of pending retirement claims from federal workers hit an eight-year low last month.
    • “The Office of Personnel Management’s retirement process and subsequent backlog has long dogged the federal government’s HR agency, frustrating agencies and departing federal employees alike, in large part due to paper-based legacy personnel systems.
    • “But last year, OPM instituted a number of measures to try to make immediate improvements to the process, including dedicating more resources and manpower during the early-year busy season for retirement claims and setting up a new dashboard for claimants to better understand the process and avoid common pitfalls.
    • “In May, OPM received 6,751 new retirement applications, a slight decrease from the 6,901 it received the previous month. But after a modest decrease in the number of claims actually processed in April, the agency increased its pace again last month, processing 8,793 claims.
    • “By the end of the month, the backlog had fallen to 14,035, compared to 16,077 pending claims at the end of April. That marks the smallest retirement backlog OPM has experienced since May 2016, when it also finished the month with a backlog of 14,035 applications.”

From the public health and medical research front,

  • The Centers for Disease Control informs us,
    • Summary
      • Seasonal influenza, COVID-19, and RSV activity is low nationally.
    • COVID-19
      • Most key indicators are showing low levels of activity nationally. However, COVID-19 test positivity has increased to 4.5%. Wastewater viral activity is showing increases in some states. We also estimate that COVID-19 infections are growing or likely growing in 30 states and territories, declining or likely declining in 1 state or territory, and are stable or uncertain in 18 states and territories, based on Rt estimates of epidemic growth. An increasing proportion of the variants that cause COVID-19 are projected to be KP.3 and LB.1 (CDC COVID Data Tracker: Variant Proportions).
    • Influenza
    • RSV
      • Nationally, RSV test positivity remains low. Hospitalization rates are low in all age groups.
    • Vaccination
  • The Washington Post offers background on bird flu — How it spreads, milk and egg safety and more.
  • The New York Times reports,
    • “The American Cancer Society has begun an ambitious, far-reaching study focusing on a population that has long been overlooked, despite high rates of cancer and cancer-related deaths: Black women.”The American Cancer Society has begun an ambitious, far-reaching study focusing on a population that has long been overlooked, despite high rates of cancer and cancer-related deaths: Black women.
    • “The initiative, called VOICES of Black Women, is believed to be the first long-term population study of its size to zero in specifically on the factors driving cancer prevalence and deaths among Black women.
    • “Researchers plan to enroll 100,000 Black women without cancer, ages 25 to 55, in Washington, D.C., and 20 states where most Black American women reside. The subjects will be surveyed twice a year about their behaviors, environmental exposures and life experiences, and followed for 30 years; any cancers they may develop will be tracked.
    • “Similar studies by the American Cancer Society in the past yielded critical lessons about what causes cancer — for example, identifying cigarette smoking as a cause of lung cancer and linking red- and processed-meat consumption to increased risk of colon cancer.”
  • STAT News points out,
    • “The moment when a person stops taking their antidepressant is fraught. Not only can patients see their psychiatric symptoms return, but they can experience a wide variety of new symptoms in the days and weeks immediately following the medication change.
    • “Symptoms like nausea and headache can be manageable, and typically begin and end within days of ending the medication. But more disruptive effects like insomnia, irritability, and sensory disturbance, or even severe ones like suicidal ideation or lethargy, can lead patients to reconsider their decision to stop treatment, even when they resolve relatively rapidly.
    • “A new systematic review of studies on antidepressant discontinuation published on Tuesday in The Lancet Psychiatry provides insight into the frequency and gravity of those symptoms. The review, which included 79 studies capturing 21,000 patients, found that about 15% experienced withdrawal symptoms after weaning from antidepressants. In 2 to 3% of the cases, the symptoms were severe.
    • “The analysis “is an important and long overdue contribution to the research literature,” said Awais Aftab, a professor of psychiatry at Case Western Reserve University School of Medicine, who did not participate in the study. It confirms that withdrawal symptoms do happen with clinically relevant frequency, and should be managed with care. But it demonstrated a lower incidence than recent estimates based on online surveys, which generated public alarm when they suggested symptoms may occur in half or more of the patients.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Humana and CVS, two of the largest Medicare Advantage insurers in the country, are poised to seriously downgrade their plan benefits and geographic presence next year as they chase profits in the privately run Medicare program.”Humana and CVS, two of the largest Medicare Advantage insurers in the country, are poised to seriously downgrade their plan benefits and geographic presence next year as they chase profits in the privately run Medicare program.
    • “As a result, hundreds of thousands of Medicare Advantage seniors — and the billions in revenue they represent — could come up for grabs, representing a significant opportunity for insurers looking to take on more members despite ongoing challenges in MA.
    • “The size of the turnover depends on a number of factors. Deciding which benefits to cut versus keep is a tough calculus, and there are guardrails from the federal government limiting cutbacks, experts say.
    • “Those decisions have been made — bids were due to the CMS on Monday. However, it will be months before the industry knows how much turbulence Humana and CVS might cause in their drive to bolster profits next year, and which insurers might benefit.
    • “Of the national payers, market leader UnitedHealth may be best situated to pick up switching seniors, solidifying its dominance in MA, experts say.
    • “I think there will be a huge shakeup,” Alexis Levy, the managing director of health consultancy Chartis’ payer advisory practice, said.”
  • Beckers Payer Issues notes,
    • “Artificial intelligence has the potential to lower internal and member costs, for insurers while also increasing profits, but the industry has largely not embraced these opportunities, according to a June 5 analysis from McKinsey.”Artificial intelligence has the potential to lower internal and member costs, for insurers while also increasing profits, but the industry has largely not embraced these opportunities, according to a June 5 analysis from McKinsey.
    • “Incremental approaches will continue to yield only minor savings, as we have seen to date across most of the industry,” the analysts wrote. “To capture full value, payers must reimagine the end-to-end processes of each domain.”
    • “Three key takeaways: 
      • 1. “If payers fully implemented already available generative AI and automation technologies, on average they could save 13-25% on administrative costs, 5-11% on medical costs and increase revenues by 3-12%.
      • 2. “Marketing and sales, utilization management, and IT are the divisions with the largest potential opportunities when using AI.
      • 3. “Payers that want to better use AI technology should have these six key things: a strategic plan, the right talent, a conducive operating model, technological capabilities, consumable data and the ability to ensure adoption and scale.
      • “In general, most payers are ill-equipped to pursue this opportunity,” the analysts wrote. “To do so, they have to close the gap that exists between their current capabilities and those needed to fully address the six areas outlined above.”
  • STAT News relates,
    • “Amid rising concern over prescription drug shortages, a new report finds that the number of shortages has increased over the past decade, most are lasting longer than ever before, and the problem is affecting medicines used to treat a wide range of maladies.
    • “Specifically, the average shortage lasted for more than three years in 2023 compared to about two years in 2020, and 27 of the 125 drugs in short supply were not available for more than five years. And 53% of new shortages occurred among generic sterile injectable medicines, according to the report from U.S. Pharmacopeia, an independent organization that develops standards for medicines.
    • “Meanwhile, most medicines for which shortages existed cost less than $5; nearly one-third of injectables cost less than $2; and two-thirds of solid oral medicines cost $3 or less. These low prices also translated into more product discontinuations, which rose by 40% from 2022 to 2023, and from 100 drugs to 140 during that time. This was also the highest rate of product discontinuations since 2019.
    • “A key culprit, according to U.S. Pharmacopeia, often are thin profit margins. “Economic pressures, especially the very low prices that generics manufacturers recover for many medicines, along with contracts that are frequently broken, have left our generic medicine supply chain fragile,” said Anthony Lakavage, senior vice president for global external affairs, in a statement.”

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.”

 

Weekend Update

David Ermer–Congress, COVID-19, Medical / Rx research, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Washington, DC

  • Forbes columnist Avik Roy writes about good and bar Congressional efforts to control drug pricing.

From the American Society of Clinical Oncology (ASCO) conference currently being held in Chicago,

  • STAT News reports
    • “In patients with stage 3 lung cancer where a particular genetic mutation is present in the tumor, taking AstraZeneca’s cancer-fighting pill Tagrisso reduced the chance that disease would progress by 84%.
    • “This will be practice changing as soon as this becomes available,” said David R. Spigel, chief scientific officer of the Sarah Cannon Research Institute at a press conference announcing the results at the annual meeting of the American Society of Clinical Oncology. “This will be how patients are treated wherever they can get access to this drug.”
  • and
    • The cancer drug Enhertu stalled the growth of tumors by more than a year, significantly longer than standard chemotherapy did in women with the most common form of metastatic breast cancer — a clinical trial result that once again promises to rewrite the rules for the treatment of the disease.
    • The makers of Enhertu, Daiichi Sankyo and AstraZeneca, said the new data, if cleared by regulators, could shift the way physicians treat hormone receptor-positive, metastatic breast cancer, and create a new standard of care in which patients with breast tumors that express even the faintest amount of HER2 protein can benefit.
    • “It’s not an overestimation to say that trastuzumab deruxtecan is the most potent drug ever developed for breast cancer,” said Paolo Tarantino, a medical oncologist at the Dana-Farber Cancer Institute, using the scientific name for Enhertu. “It does come with side effects that we’re learning to manage, but with that said, I’ve never seen data like what’s being reported here.”
    • The results, from a Phase 3 study called Destiny-Breast06, were presented Sunday at the annual meeting of the American Society of Clinical Oncology.
  • and
    • Comfort can be delivered to patients with advanced cancer virtually just as well as in person, according to a new study presented on Sunday at the American Society of Clinical Oncology annual meeting in Chicago.
    • That’s welcome news to palliative care experts who have, in many cases, preferred the convenience and efficacy of telehealth sessions for both themselves and their patients since the Covid-19 pandemic forced virtual visits.

In other public health and medical research news,

  • The Wall Street Journal seconds STAT News by reporting
    • “There is more hope than ever for people diagnosed with the deadliest cancer. 
    • “Declines in smoking and the advent of screening and newer drugs have transformed the outlook for patients with lung cancer, once considered a death sentence. Progress against the disease has propelled the drop in overall cancer deaths in the U.S. over the past three decades.
    • “And there is more to gain. More patients can fend off the disease for months or years with targeted or immune-boosting drugs, [e.g., Tagrisso] results released this weekend at a top cancer conference showed. That includes patients with forms of the disease that are notoriously tough to treat.”
  • Fortune Well offers the “best science-backed strategies for a strong mind as you age.
  • The New York Time helps readers distinguish among spring allergies, the common cold, and Covid. This article reminded the FEHBlog that the Covid public health emergency ended a year ago last month.

From the U.S. healthcare business front,

  • “Fortune Well informs us a “longevity scientist’s three surprising predictions for the growing industry of healthy aging. The longevity scientist is “Alina Su, CEO of precision medicine and health tech company Generation Lab, at Fortune’s Brainstorm Health conference in Dana Point, Calif., last week. 
  • The Washington Post explains how “author and hospitality guru Chip Conley wants to replace the midlife crisis with a midlife renaissance.”
    • “In his book “Learning to Love Midlife: 12 Reasons Why Life Gets Better With Age,” Conley, 63, asks: “What if we could reframe our thinking about the natural transition of midlife not as a crisis, but as a chrysalis — a time when something profound awakens in us, as we shed our skin, spread our wings, and pollinate our wisdom to the world?”