Friday Factoids

Rx coverage

Friday Factoids

David Ermer–CDC, Congress, FDA, Generative AI, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Govexec tells us,
    • “The Office of Personnel Management on Thursday introduced a new form of paid leave designed for federal workers to use in connection with instances of domestic violence or other sexual or relationship-based trauma.
    • “In a memo to agency heads, acting OPM Director Rob Shriver said that although the federal government’s paid leave system “was not constructed with concepts of safe leave in mind,” the Biden administration is committed to protecting feds who have undergone relationship-based trauma and their families. * * *
    • “According to a new fact sheet on OPM’s website, the new safe leave will fall into a series of pre-existing leave categories, depending on what the federal employee intends to do while on leave.”
  • The Census Bureau announced,
    • “While the nation’s fastest-growing cities continue to be in Sun Belt states, new population estimates show that some of the top gainers are now on the outskirts of metropolitan areas or in rural areas.
    • “Today’s release of U.S. Census Bureau July 1, 2023, population estimates for cities and towns reveals geographic shifts in population growth compared to pre-pandemic July 1, 2019, estimates.
    • “The estimates also show that, on average, many small and midsize U.S. cities with populations under 50,000 saw relatively higher growth rates in 2023 than in 2019 before the pandemic hit while large cities generally grew at slower rates.
    • “Overall, the most populous cities continued to return to pre-pandemic trends thanks to increased growth rates and smaller population declines.”

From the public health and medical research front,

  • The Centers for Disease Control lets us know today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is low nationally. This week, no jurisdictions experienced moderate, high, or very high activity.
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are at low levels.
    • “Nationally, influenza test positivity decreased and RSV and COVID-19 test positivity remained stable at low levels compared to the previous week.
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, is minimal.”
  • CNN reports,
    • “Laboratory tests by the US Department of Agriculture haven’t found any H5N1 bird flu virus in raw beef, but they are a good reminder why eating rare hamburgers can be risky.”Laboratory tests by the US Department of Agriculture haven’t found any H5N1 bird flu virus in raw beef, but they are a good reminder why eating rare hamburgers can be risky.
    • “As part of a suite of tests conducted to check safe food handling advice after the detection of H5N1 bird flu virus in dairy cattle, the USDA recently mixed a substitute virus into ground beef and then cooked patties at varying times and temperatures.
    • “Researchers found none of the virus in hamburgers cooked to 145 degrees, roughly the temperature of a medium burger, or well-done burgers cooked to 160 degrees. They did, however, find some live virus in patties cooked to 120 degrees or rare, although the virus was present “at much, much reduced levels,” said Eric Deeble, acting senior adviser for highly pathogenic avian influenza at the USDA.
    • “Whether that small amount of virus could make someone sick is still an unknown.
    • “The USDA already advises consumers to cook ground beef to an internal temperature of 160 degrees, as measured with a food thermometer, to avoid infections from bacteria such as salmonella and E. coli, he noted.
    • “I don’t think that anybody needs to change any of the safe food handling or safe cooking practices that are already recommended,” Deeble said.”
  • BioPharma Dive lets us know,
    • “New data from two late-stage studies of an experimental Bayer drug show it reduced the frequency and severity of common symptoms of menopause, supporting the company’s case for seeking regulatory approval.
    • “The results were disclosed by Bayer Thursday and will be presented at this year’s annual meeting of the American College of Obstetricians and Gynecologists in San Francisco.
    • “Bayer shared the trials’ success in January, but didn’t reveal specific findings. The company also announced positive results from a third Phase 3 study in March, when it confirmed plans to file for marketing authorization of the drug.
    • “Known as elinzanetant, Bayer’s drug would, if approved, compete with a medicine from Astellas called Veozah, which is approved in the U.S. to treat moderate-to-severe vasomotor symptoms caused by menopause.”
  • The New York Times reports,
    • “When a patient with a severe traumatic brain injury is comatose, in intensive care, unresponsive and hooked up to a ventilator, but not brain-dead, when is the time to withdraw life support? A small study on the fates of people in such situations suggests that doctors and patients’ families may make better decisions if they wait even a few days longer than usual.
    • “Often, a doctor sits down with family members within 72 hours of the patient’s admission to intensive care to discuss the patient’s prognosis, and whether they want to keep their loved one alive, or to remove life support.
    • “Experts say that many doctors would describe the outlook as grim — most likely death or severe disability. Reported outcomes of patients who had severe traumatic brain injuries show that most times the decision is to remove life support. The patient dies.
    • “The researchers behind the new study say that their limited data suggests that doctors’ predictions so soon after the injury frequently are wrong.
    • “The study, published Monday in Journal of Neurotrauma, used a national database that included 1,392 traumatic brain injury patients.”
  • The Wall Street Journal points out that “A ‘Digital Twin’ of Your Heart Lets Doctors Test Treatments Before Surgery. Researchers create digital replicas of individual patients’ organs using data from exams and wearable devices: ‘You can run an infinite number of experiments’.”
    • “Kristin Myers, a mechanical engineering professor at New York’s Columbia University, is making digital copies of women’s uteruses and cervixes, hoping this can help in determining how a pregnancy will go. To do this, Myers uses an ultrasound to create 3-D computational models as part of an effort to someday solve the problem of preterm births. 
    • “The idea of digital twins in health is new,” she says. “We can offer better diagnoses. You can run an infinite number of experiments.”  
    • “At the National Cancer Institute, Emily Greenspan, a program director in the informatics and data science program, envisions a novel way to treat oncology patients. Instead of trying a drug and hoping it works, doctors would create a digital twin of the patient to predict how the disease would respond to a certain drug. 
    • “The institute has been working on creating virtual twins for best treatments of lung cancer, for instance. In the next five years the technology will likely become part of clinical decision-making, Greenspan says. 
    • “Predicting the best treatments and screening, these are blue-sky visions,” she said. “There is a lot of foundational research that’s needed.”
  • Amazing.

From the U.S. healthcare business front,

  • Beckers Payer Issues informs us,
    • “Employer adoption of ICHRAs is up 29% since 2023, according to a May 16 report from the HRA Council.
    • “ICHRAs, or individual coverage health reimbursement arrangements, allow employers to offer a defined tax-advantaged contribution used to reimburse premiums for an individual health plan purchased by an employee on their state’s ACA exchange.
    • “Key numbers:
      • “1. ICHRA adoption grew 29% year over year between 2023 and 2024.
      • “2. ICHRAs grew 84% among employers with 50 or more employees.
      • “3. Among employers surveyed, 83% were not able to offer health benefits until they offered an ICHRA or Qualifying Small Employer HRA. 17% of employers switched from traditional group coverage.
      • “4. The number of employees offered a defined contribution health benefit now exceeds 200,000, which does not include dependents — some estimates have said more than 500,000 people are enrolled.”
  • Per Fierce Healthcare,
    • “For women who experience musculoskeletal (MSK) and pelvic health issues, the decline in estrogen during menopause can not only worsen existing symptoms but also trigger new joint, muscle and pelvic health issues.
    • “Research shows 71% of women who go through menopause experience joint and muscle pain.
    • “Digital health company Hinge Health expanded its movement- and behavior-based care to help women alleviate common menopause symptoms such as hot flashes, joint and muscle pain and pelvic floor disorders.             
    • “As part of the new movement-based menopause support offering, a physical therapist-led care team provides individuals with personalized exercise therapy and behavior-based lifestyle modifications. The aim is to alleviate joint and muscle pain, maintain muscle mass and bone density, and address vasomotor symptoms like hot flashes and mood swings, according to the company.
    • “Regular physical activity can reduce the frequency and severity of some disruptive symptoms that occur with menopause,” said Tamara Grisales, M.D., an urogynecologist at Hinge Health. “Exercise-focused programs complement traditional treatments like Hormone Replacement Therapy, providing a holistic approach to managing menopause.”
  • Beckers Hospital Review notes,
    • “Walgreens will sell a low-cost, over-the-counter version of the opioid overdose antidote naloxone, the company said May 15. 
    • “The Walgreens-brand nasal spray medication will retail for $34.99, a lower price than other branded versions of the drug (Narcan) sold by the retailer. The naloxone spray is currently available online and will hit store shelves nationwide by the end of the month.”

Thursday Miscellany

David Ermer–AHRQ, CDC, Congress, FDA, Medical / Rx research, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Hill informs us,
    • “Blockbuster weight-loss drug Wegovy could bankrupt the U.S. health care system unless the price drops, according to a staff report released Wednesday from the office of Senate Health Committee Chair Bernie Sanders (I-Vt.). 
    • “Unless prices dramatically decline, Wegovy and weight loss drugs could push Americans to spend $1 trillion per year on prescription drugs, the report concluded.
    • “Pricing drugs based on their value cannot serve as a blank check, or the sole determinant for how we understand what to pay for essential goods,” the report stated. As important as these drugs are, they will not do any good for the millions of patients who cannot afford them.” 
    • “The report ups the pressure from Sanders on Danish drugmaker Novo Nordisk to lower the price of Wegovy and Ozempic.”
  • The good Senator has a point here. Drug manufacturers need a dose or two of price reasonableness.
  • STAT News reports,
    • “A House subcommittee on Thursday advanced legislation that would extend some pandemic-era telehealth policies in Medicare for two years, bringing the panel’s approach in line with another committee.
    • “During the pandemic, Congress extended flexibilities that changed what kinds of care Medicare beneficiaries could receive over telehealth and where. Originally, the House Energy and Commerce health subcommittee had considered a bill that would have enacted the policies permanently, but amended the legislation Thursday to pare it down to a two-year extension. The bill passed to the full committee unanimously on a 21-0 vote.
    • “The approach is in line with that of another panel, the House Ways and Means Committee, which passed a two-year extension earlier this month. Both bills include similar provisions that would pay for the extension in part through reforms to the way in which pharmacy middlemen operate.”
  • American Hospital Association News shares,
    • “The AHA shared a series of proposals to strengthen rural health care with the Senate Finance Committee for a hearing May 16 titled, “Rural Health Care: Supporting Lives and Improving Communities.” The proposals include policies promoting flexible payment options; ensuring fair, timely and adequate reimbursement; bolstering the workforce; and improving maternal health. During the hearing, several members focused on access to obstetric services and augmenting the number of medical residency slots awarded to rural hospitals. Jeremy P. Davis, MHA, president and CEO of AHA-member Grande Ronde Hospital in La Grande, Ore., and other health care leaders and policy researchers testified.”
  • The Department of Health and Human Services celebrates the Administration’s mental healthcare accomplishments.
  • The New York Times reports,
    • “The Food and Drug Administration on Thursday approved an innovative new treatment for patients with a form of lung cancer. It is to be used only by patients who have exhausted all other options to treat small cell lung cancer, and have a life expectancy of four to five months. * * *
    • “Each year, about 35,000 Americans are diagnosed with small cell lung cancer and face a grim prognosis. The cancer usually has spread beyond the lung by the time it is detected. * * *
    • “The drug tarlatamab, or Imdelltra, made by the company Amgen, tripled patients’ life expectancy, giving them a median survival of 14 months after they took the drug. Forty percent of those who got the drug responded.
    • “After decades with no real advances in treatments for small cell lung cancer, tarlatamab offers the first real hope, said Dr. Anish Thomas, a lung cancer specialist at the federal National Cancer Institute who was not involved in the trial.
    • “I feel it’s a light after a long time,” he added.”
  • Tammy Flanagan, writing in Govexec, discusses FEHB annuitant reactions to Part D EGWP offerings in various FEHB plans for 2024.
  • Federal News Network notes,
    • After a couple years of uncertainty, satisfaction among federal employees is beginning to rise at many agencies.
    • In a preview of the latest Best Places to Work in the Federal Government rankings, out of the top 10 agencies in each of the four categories — large, midsize and small agencies, as well as agency subcomponents — prioritizing employee engagement was the common thread, the Partnership for Public Service said.
    • “At a time when our nation faces both critical challenges and exciting opportunities at home and abroad, an engaged federal workforce is vitally important,” Max Stier, president and CEO of the Partnership for Public Service, said in a statement. “The top-ranked agencies have excelled at keeping their workforces engaged and motivated and, as a result, they are well positioned to deliver results for the public.” * * *
    • “The Environmental Protection Agency, Energy Department, Office of Personnel Management and National Credit Union Administration all moved up in the rankings and increased their overall scores.” 
  • The CDC is promoting its new and improved website.

From the public health and medical research front,

  • The New York Times informs us,
    • “With Pride events scheduled worldwide over the coming weeks, U.S. officials are bracing for a return of mpox, the infectious disease formerly called monkeypox that struck tens of thousands of gay and bisexual men worldwide in 2022. A combination of behavioral changes and vaccination quelled that outbreak, but a majority of those at risk have not yet been immunized.
    • “On Thursday, the Centers for Disease Control and Prevention warned of a deadlier version of mpox that is ravaging the Democratic Republic of Congo and urged people at risk to be vaccinated as soon as possible. No cases of that subtype have been identified outside Africa so far. But the escalating epidemic in Congo nevertheless poses a global threat, just as infections in Nigeria set off the 2022 outbreak, experts said.
    • “This is a very important example of how an infection anywhere is potentially an infection everywhere, and why we need to continue to improve disease surveillance globally,” said Anne Rimoin, an epidemiologist at the University of California, Los Angeles. * * *
    • “The C.D.C. is focusing on encouraging Americans at highest risk to become vaccinated before the virus resurges. The agency’s outreach efforts include engaging with advocacy groups and social media influencers who have broad appeal among the L.G.B.T.Q. community. In December, the agency urged clinicians to remain alert for possible cases in travelers from Congo.”
  • and
    • “Heart disease, diabetes and kidney disease are among the most common chronic illnesses in the United States — and they’re all closely connected.
    • “Adults with diabetes are twice as likely to have heart disease or a stroke compared with those who don’t have diabetes. People with diabetes — Type 1 and Type 2 — are also at risk of developing kidney disease. And when the kidneys don’t work well, a person’s heart has to work even harder to pump blood to them, which can then lead to heart disease.
    • “The three illnesses overlap so much that last year the American Heart Association coined the term cardiovascular-kidney-metabolic syndrome to describe patients who have two or more of these diseases, or are at risk of developing them. A new studysuggests that nearly 90 percent of American adults already show some early signs of these connected conditions.
    • “While only 15 percent of Americans meet the criteria for advanced stages of C.K.M. syndrome, meaning they have been diagnosed with diabetes, heart disease or kidney disease or are at high risk of developing them, the numbers are still “astronomically higher than expected,” said Dr. Rahul Aggarwal, a cardiology fellow at Brigham and Women’s Hospital in Boston and co-author of the study.
    • “The research suggests that people should pay attention to shared risk factors for these diseases early on — including excess body fat, uncontrolled blood sugar, high blood pressure and high cholesterol or triglyceride levels.”
  • BioPharma Dive points out,
    • “An experimental Roche drug helped people with obesity lose an average of nearly 19% of their body weight over six months, after adjusting for placebo, in an early-stage trial, the company said Thursday.
    • “Roche is awaiting additional data from a study of the drug, called CT-388, in people with diabetes as well as obesity. It also didn’t provide specifics on the drug’s side effect profile. CT-388 is currently only in a Phase 1 program involving 96 people. Larger and longer trials are needed before the company can ask the Food and Drug Administration for approval.
    • “Roche acquired CT-388 through a $2.7 billion acquisition of biotechnology startup Carmot Therapeutics in December. The deal was part of a rush by pharmaceutical companies to capture a share of a market estimated to be worth more than $100 billion annually by early next decade.”
  • and
    • “A once-weekly form of insulin being developed by Eli Lilly proved just as effective at controlling blood sugar in adults with diabetes as commonly used daily injections, according to results from two clinical trials that were released by the drugmaker Thursday.”A once-weekly form of insulin being developed by Eli Lilly proved just as effective at controlling blood sugar in adults with diabetes as commonly used daily injections, according to results from two clinical trials that were released by the drugmaker Thursday.
    • “Lilly is betting that its experimental drug, dubbed insulin efsitora alfa, could provide a longer-lasting and more convenient option than daily treatment for managing diabetes. 
    • “With efsitora, we have an opportunity to provide an innovative once-weekly solution that safely achieves and maintains A1C control, reduces treatment burden of traditional daily injections and potentially improves adherence for people with diabetes,” said Jeff Emmick, a senior vice president of product development for Lilly, in a statement on the trial results.” 
  • The National Institutes of Health Director, in her blog, discusses “Speeding the Diagnosis of Rare Genetic Disorders with the Help of Artificial Intelligence.”
  • The National Institutes of Health announced,
    • “People were more likely to develop a type of treatment-resistant hypertension when they experienced adverse effects of economic and social conditions that influence individual and group differences in health status, known as social determinants of health. Additionally, this risk was higher among Black American adults than white American adults, according to a study funded by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.”People were more likely to develop a type of treatment-resistant hypertension when they experienced adverse effects of economic and social conditions that influence individual and group differences in health status, known as social determinants of health. Additionally, this risk was higher among Black American adults than white American adults, according to a study funded by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.
    • “Factors linked to this increased risk included having less than a high school education; a household income less than $35,000; not seeing a friend or relative in the past month; not having someone to care for them if ill or disabled; lack of health insurance; living in a disadvantaged neighborhood; and living in a state with low public health infrastructure. Apparent treatment-resistant hypertension is defined as the need to take three or more types of anti-high blood pressure medication daily and is associated with an increased risk for stroke, coronary heart disease, heart failure, and all-cause mortality.”
  • The U.S. Preventive Services Task Force released a final research plan for “Unhealthy Alcohol Use in Adolescents and Adults: Screening and Behavioral Counseling Interventions.”
  • Beckers Hospital Review alerts us,
    • “In 2023, patient falls were once again the most common sentinel event reported by healthcare organizations, according to a May 15 report from The Joint Commission.
    • “The Joint Commission defines a sentinel event as a patient safety event that results in death, permanent harm, severe temporary harm or intervention required to sustain life.
    • “The accrediting body received 1,411 reports of sentinel events in 2023, on par with the volume reported in 2022. Only a small portion of all sentinel events are reported to The Joint Commission, meaning conclusions about the events’ frequency and long-term trends should not be drawn from the dataset, the organization said.
    • “In total, 96% of healthcare organizations voluntarily reported sentinel events. About 18% of events were associated with patient death, 8% with permanent harm or loss of function, 57% with severe temporary harm and 12% with unexpected additional care or extended healthcare stays.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “One reason U.S. inflation is still high: Increases in prices for procedures to prop open clogged arteries, provide intensive care for newborns and biopsy breasts.
    • “Hospitals didn’t raise prices as early in the pandemic as supermarkets, retailers and restaurants. But they have been making up ground since then. Their increases have contributed to stubbornly high inflation readings from the consumer-price index, which in April increased 3.4% from a year ago. 
    • “Hospital prices specifically jumped 7.7% last month from a year ago, the highest increase in any month since October 2010, the Labor Department said Wednesday. * * *
    • Economists said they expect higher hospital inflation to persist as recent years’ labor-market disruption continues to ripple through wages and health-insurance contracts. 
    • “We’re not expecting much slowing,” said Alan Detmeister, an economist for UBS. “This was a very large shock that we saw in the healthcare industry over Covid, and it takes years for those to pass through to the prices.”
    • Hospital price increases are responsible for about 23% of the growth in U.S. health spending each year, on average, according to an analysis by federal actuaries for the Journal. Health-insurance premiums last year shot up at the fastest rate in a decade. 
    • Premiums rise with health spending. Public employees in California saw premiums increase 11% this year, largely because of rising prices, which alone raised their premiums by 8%, said the California Public Employees’ Retirement System. 
  • Healthcare Finance adds,
    • The Centers for Medicare and Medicaid Services’ January [2024] expansion of the two-midnight rule to include Medicare Advantage plans has contributed to higher inpatient volumes and revenue growth in the first quarter of the year, according to a Strata Decision Technology report.
    • This is because inpatient services have higher reimbursement levels compared to outpatient services and the two-midnight rule concerns inpatient care.
  • Per Fierce Healthcare,
    • “Though held in check by inflation, Cleveland Clinic’s first-quarter operations trickled past last year’s tally thanks to a jump in volumes and revenues.
    • The nonprofit system reported this week a $50.2 million operating gain (1.3% operating margin), as opposed to the prior year’s $32.3 million (0.9% operating margin). Operating revenues rose 10.2% year over year to nearly $3.9 billion while operating expenses followed close behind with a 9.8% increase.
    • “Cleveland Clinic enjoyed “strong demand for both inpatient and outpatient services” during the quarter, management wrote in commentary on its operations. Compared to the prior year, acute admissions rose 6.7%, total surgical cases by 3.7% and outpatient evaluation and management visits by 3.9%.
    • “The system’s 9.4% increase in net patient service revenue was also boosted by rate increases among Cleveland Clinic’s managed care contracts that went into effect with the new year. Additionally, management wrote, “over the last few years, the system initiated national, regional and local revenue management projects designed to improve patient access throughout the system while striving to ensure the safety of patients, caregivers and visitors.”
  • According to Healthcare Dive,
    • “[Philadelphia based] Jefferson Health and [Allentown, PA, based] Lehigh Valley Health Network signed a definitive agreement Wednesday to merge. The health systems expect the deal to close later this summer, pending regulatory approval, according to a press release. Deal terms were not disclosed.”
  • Fierce Healthcare adds,
    • “UnitedHealth Group’s investments in affordable housing have topped $1 billion, with the program a keystone in its overarching strategy to address health equity and disparities.
    • “The company has made investments in housing since 2011 and, in that time, has supported the development of affordable and mixed income units across 31 states and the District of Columbia, creating more than 25,000 homes for people and families who face housing insecurity.
    • “The investments include direct funding from the company as well as those made through Low-Income Housing Investment Tax Credits and Community Reinvestment Act loans, UnitedHealth said. The company has backed both new development and rehabilitation for older locations in urban, suburban and rural markets. * * *
    • “UnitedHealth is tracking the health benefits of these investments and spent two years measuring outcomes against a baseline set by Stewards of Affordable Housing for the Future and the National Affordable Housing Trust. It found that people living in the properties it backed were more likely to receive annual checkups, with 95% having one in the past year.
    • “In addition, residents living in these locations reported better mental health compared to low-income individuals across the country.”

Tuesday Tidbits

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Govexec lets us know,
    • “The U.S. Postal Service is pausing some of the most controversial reforms to its mailing network as its leadership has agreed to the demands of a growing, bipartisan chorus in Congress. 
    • “The mailing agency has halted its plans to consolidate dozens of processing facilities until at least Jan. 1, 2025, ensuring the network overhaul is paused until after the upcoming presidential election in which millions of Americans will be voting by mail. A large swath of lawmakers across the ideological spectrum have called on Postmaster General Louis DeJoy to delay or cease the changes, some of which would shift the bulk of mail processing across state lines. 
    • “The decision marks a reversal for DeJoy, who just last week remained resolute in defending his vision as the only viable path forward for his agency. He called the issue an existential one, saying his reforms were “what we must continue to do to survive.” 
  • HHS’s Agency for Healthcare Research and Quality posted its March 2024 “NATIONAL HEALTHCARE QUALITY AND DISPARITIES REPORT CHARTBOOK ON PATIENT SAFETY.”
  • Per an FDA press release, “[o]n Monday [May 13], the FDA issued a safety communication to warn patients, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests due to an increased risk of false results. The FDA had also issued a Warning Letter to Cue Health after an inspection revealed that the company made changes to these tests and that the changes reduced the reliability of the test to detect SARS-CoV-2 virus.” 

From the public health and medical research front,

  • The Washington Post reports,
    • “The coronavirus has once again evolved, in a familiar echo of past years. Unlike earlier iterations of the virus, this new variant is not sparking widespread havoc.
    • “The Centers for Disease Control and Prevention said it is monitoring a variant called KP.2 and does not see evidence it causes more severe illness than other strains. Laboratory tests have shown that KP.2 is not causing a surge in infections or transmission, the agency said.
    • “The CDC has identified a second emergent variant, KP.1.1. But it is KP.2 that is leading the pack. Both new variants belong to a group of coronavirus variants dubbed “FLiRT” by scientists. The acronym was coined to describe a combination of mutations found in the spike protein of the SARS-CoV-2 virus. * * *
    • “KP.2 has symptoms similar to earlier versions of the virus, including fever, chills, cough and muscle or body aches.”
    • The current vaccines are effective against KP.2. [“H]ealth experts predict that the new formulation of the coronavirus expected for the fall could offer even stronger protection because it will probably be tailored to thwart the new variant.”
  • Beckers Hospital News informs us,
    • “On average, people taking Novo Nordisk’s weight loss drug Wegovy see a 10% reduction in weight, which is sustained for four years, according to findings from a major trial published May 13.  * * *
    • “Wegovy is tied to a 20% reduced risk of heart attacks and other cardiovascular events — a benefit that was seen across the board, irrespective of how much weight people lost.” 
  • STAT News adds,
    • “Novo Nordisk will test whether its GLP-1 drugs can help people with alcohol-associated liver disease, and, as part of that, will study if the treatments will change the amount of alcohol people drink.
    • “This appears to be the first time the company is getting involved in research to see if the booming class of GLP-1 diabetes and obesity drugs can affect substance consumption, a question that academic researchers have been probing but the pharmaceutical industry has so far avoided.
    • “The nine-month study will try three drugs alone and in combinations against placebo. The primary outcome being tested is change in liver scarring, or fibrosis, and one of the secondary outcomes is changes in alcohol consumption. The news of the study was first reported by Bloomberg.
    • “The medications that will be tested include the blockbuster semaglutide, sold as the diabetes drug Ozempic and obesity drug Wegovy, as well as CagriSema, a drug Novo is developing that combines semaglutide with the dual amylin and calcitonin receptor agonist cagrilintide. A third drug, NNC0194-0499, targets FGF-21, a hormone produced by the liver that plays a role in inflammation.”
  • NIH’s All of Us Program posted its latest newsletter.
  • Per an Institute for Clinical and Economic Research press release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of 3,4-Methylenedioxymethamphetamine-assisted psychotherapy (MDMA-AP; Lykos Therapeutics) for the treatment of post-traumatic stress disorder (PTSD). * * *
    • “Key Clinical Findings
    • “Although ICER attempted to explore the concerns raised about MDMA-AP and the MAPP trials, ICER was not able to assess the extent that bias influenced reporting of benefits or the frequency with which there may have been misreporting of harms. As such, ICER concluded that the current publicly available evidence is insufficient (“I”) to assess the overall net benefit of MDMA-AP. 
    • “Key Cost-Effectiveness Findings
    • “Given the “I” rating, the economic analyses of MDMA-AP in this Evidence Report are only exploratory analyses that provide insights into costs and benefits if it is assumed that the results of the MAPP trials are accurate. ICER did not calculate a health-benefit price benchmark for MDMA-AP.”
  • Benefitfocus released an “Employee Benefits Strategy Playbook for Mental Healthcare.

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “The majority of the nation’s leading for-profit hospital systems by revenue reported net gains during the first quarter led by stronger than expected inpatient volumes.
    • “The boost in inpatient volumes and associated revenue comes just a quarter after providers said they would be betting more heavily on outpatient services to drive growth. 
    • “Increases in inpatient revenues is an area to watch as providers weigh whether and how to adjust their portfolios. Community Health Systems, for example, has been on a selling spree recently in an attempt to deleverage its balance sheets, while HCA Healthcare, Tenet Healthcare and Universal Health Services are expanding services in key markets. 
    • “Should inpatient care utilization continue to rise over multiple quarters, it could influence hospitals’ capital spending, according to research notes from analysts.”
  • BioPharma Dive tells us,
    • “Biosimilars are gaining ground. The IRA could push them further next year.
    • “As commercial momentum builds, coverage incentives for the Medicare market are expected to favor biosimilars in 2025.”
  • Modern Healthcare reports,
    • Behavioral health provider Talkspace rolled out services Tuesday to 13 million Medicare members across 11 states and will expand to 33 million members nationwide by the end of the year.
    • Talkspace services are available to those with traditional Medicare in California, Florida, New York, Ohio, New Jersey, Virginia, Missouri, Maryland, South Carolina, New Mexico and Idaho. The company plans to offer services to Medicare Advantage members later on, as well.

Tuesday Tidbits

David Ermer–ACA, CDC, Congress, FDA, Medical / Rx research, NCQA, NIH, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DCm

  • The Wall Street Journal reports,
    • “House Democratic leaders said they would block any effort to remove Speaker Mike Johnson (R., La.), moving to protect the Republican leader from retaliation by his hard-right flank following the passage of a sweeping foreign-aid package that included funding for Ukraine.”
  • This is a smart move because accord to what the FEHBlog has been reading, the Democrats are likely to retake the House of Representatives in the fall election.
  • The Journal also relates,
    • “The Federal Trade Commission is challenging hundreds of pharmaceutical patent listings in an effort to smooth the path to more affordable alternatives to brand-name drugs—including blockbusters such as Ozempic and Victoza.
      • “The crackdown is the latest assault against what the agency regards as drugmakers’ patent ploys intended to stall generic competition.
      • “At issue is what is called the Orange Book, a document published by the Food and Drug Administration that lists patents relevant to brand-name pharmaceuticals. Under a law meant to encourage generics, if a generics maker can successfully challenge listed patents, it can be granted a period of exclusivity before other generics are approved. But a challenge to an Orange Book patent, should a brand-name manufacturer decide to fight in court, also delays a generic’s approval for 30 months.
      • “The FTC says that drugmakers needlessly list oodles of extra patents in the Orange Book, delaying generic alternatives and artificially keeping prices high.”
  • HealthLeaders Media adds,
    • “Medicare Part D saved nearly $15 billion over six years with the use of “skinny label” generics, a new report says.
    • “However, the program is imperiled by a lawsuit claiming patent infringement, researchers at Brigham and Women’s Hospital and Harvard Medical School said in a research letter published on Monday in Annals of Internal Medicine.
    • “The researchers are urging Congress to “reinforce the skinny-label pathway by creating a safe harbor that protects manufacturers engaged in skinny labeling from induced patent infringement laws.”
    • “Skinny labels permit the use of generics for conditions that are not specified by brand-name drug makers and allow the cheaper generics to enter the market before the patent of the brand-name drug expires. 
  •  The U.S. Preventive Services Task Force finalized a breast cancer screening recommendation today.
    • The Task Force now recommends that all women get screened for breast cancer every other year starting at age 40 [previously age 50 for USPSTF purposes and 40 for Affordable Care Act purposes] and continuing through age 74. This is a B grade. More research is needed about whether and how additional screening might help women with dense breasts stay healthy and on the benefits and harms of screening in women older than 75. These are I statements.
  • The New York Times adds,
    • “In 2009, the task force raised the age for starting routine mammograms to 50 from 40, sparking wide controversy. At the time, researchers were concerned that earlier screening would do more harm than good, leading to unnecessary treatment in younger women, including alarming findings that lead to anxiety-producing procedures that are invasive but ultimately unnecessary.
    • “But now breast cancer rates among women in their 40s are on the rise, increasing by 2 percent a year between 2015 and 2019, said Dr. John Wong, vice chair of the task force. The panel continues to recommend screening every two years for women at average risk of breast cancer, though many patients and providers prefer annual screening. * * *
    • “Weighing in again on a hotly debated topic, the task force also said there was not enough evidence to endorse extra scans, such as ultrasounds or magnetic resonance imaging, for women with dense breast tissue.
    • “That means that insurers do not have to provide full coverage of additional screening for these women, whose cancers can be missed by mammograms alone and who are at higher risk for breast cancer to begin with. About half of all women aged 40 and older fall into this category.”
  • For Affordable Care Act preventive services coverage purposes, HHS’s Human Resources and Services Administration, not the USPSTF, is the final decision maker regarding the scope of women’s healthcare preventive services.

From the public health and medical research fronts,

  • STAT News lets us know today.
    • “Research is still being done to determine if all pasteurization techniques — there are multiple approaches — inactivate the [H5N1] virus. But the findings so far are reassuring. Scientists at St. Jude Children’s Hospital in Memphis, Tenn., have reported that while they could find genetic evidence of the virus in milk bought in stores, they could not grow live viruses from that milk, suggesting pasteurization kills H5N1. * * *
    • “But given the concentration of virus that researchers are seeing in milk from infected cows, they believe that raw milk — milk that has not been pasteurized — is an entirely different story.
    • “If cows that produce milk destined for the raw milk market got infected with H5N1, people who consume that milk could drink a large dose of the virus, scientists say. Thijs Kuiken, a pathologist in the department of viroscience at Erasmus Medical Center in Rotterdam, the Netherlands, said he’s heard of concentrations that would be the equivalent of a billion virus particles per milliliter of milk. He told STAT he thought authorities should ban raw milk sales while the outbreak is underway.”
  • The Washington Post reports,
    • “Postpartum depression is a leading cause of maternal death, but its diagnosis and treatment is spotty at best, negligent at worst.
    • “Now San Diego-based start-up Dionysus Digital Health is pitching a blood test to check for the condition, even before symptoms appear. The company says it has pinpointed a gene linking a person’s moods more closely to hormonal changes. The test uses machine learning to compare epigenetics — how genes are expressed — in your blood sample with benchmarks developed during a decade of research into pregnant people who did and didn’t develop postpartum depression.
    • “Researchers at Dionysus’s academic partners, the Royal’s Institute of Mental Health Research and UVA Health, have published peer-reviewedpapers affirming their findings, and the company is partnering with the Department of Defense and the National Institutes of Health for clinical trials, with the eventual goal of making the $250 test widely available and covered by insurance.” 
  • The National Institutes of Health announced,
    • “Sleep apnea and low oxygen levels while sleeping are associated with epilepsy that first occurs after 60 years of age, known as late-onset epilepsy, according to a new study funded by the National Institutes of Health (NIH) and published in Sleep. The link was independent of other known risk factors for late-onset epilepsy and sleep apnea including hypertension and stroke. The findings may help to better understand the relationship between sleep disorders and late-onset epilepsy, as well as identify potential targets for treatment.
    • “There’s increasing evidence that late-onset epilepsy may be indicative of underlying vascular disease, or neurodegenerative disease, even potentially as a preclinical marker of neurodegenerative disease,” said Rebecca Gottesman, M.D., Ph.D., chief of the Stroke Branch at the NIH’s National Institute of Neurological Disorders and Stroke (NINDS), and an author on the study. “Compared to other age groups, older adults have the highest incidence of new cases of epilepsy – up to half of which have no clear cause. Sleep apnea is common among people with epilepsy, but the association is not well understood.”
  • and
    • “Researchers have discovered that the smooth muscle cells that line the arteries of people with atherosclerosis can change into new cell types and develop traits similar to cancer that worsen the disease. Atherosclerosis is characterized by a narrowing of arterial walls and can increase risk of coronary artery disease, stroke, peripheral artery disease, or kidney disorders. The findings, supported by the National Institutes of Health (NIH), could pave the way for the use of anti-cancer drugs to counteract the tumor-like mechanisms driving the buildup of plaque in the arteries, the major cause of cardiovascular disease.
    • “This discovery opens up a whole new dimension for our understanding about therapeutic strategies for the prevention and treatment of atherosclerosis,” said Ahmed Hasan, M.D., Ph.D., program director in the Division of Cardiovascular Sciences at the National Heart, Lung, and Blood Institute, part of NIH. “Previous research has suggested that atherosclerosis and cancer may share some similarities, but this association has not been fully described until now.”
  • The Wall Street Journal tells us,
    • “An emerging field of research called chrononutrition indicates that choosing the right foods and meal times may improve our sleep. Some key findings: Eat dinner early. Keep consistent schedules. And, yes, drink milk.
    • You already know that fruits, veggies and lean protein are good for your health. But they can boost your sleep, too. These foods are the basis for the Mediterranean diet, which research shows may improve sleep quality, reduce sleep disturbances and boost sleep efficiency—the amount of time you spend asleep when you are in bed.” 

From the U.S. healthcare business front,

  • Healthcare Dive informs us,
    • “Walmart is closing its network of health clinics after failing to make them profitable, in a major setback for the retail giant’s push into healthcare.”Walmart is closing its network of health clinics after failing to make them profitable, in a major setback for the retail giant’s push into healthcare.
    • “Walmart Health launched as a one-store pilot in Georgia in 2019, and has since grown to 51 centers in five states, along with a virtual care offering. Yet the network has shown recent signs of trouble: Earlier this month, Walmart decelerated its expansion plans for the centers, which offer inexpensive, fixed-cost medical services like primary and dental care.
    • “Walmart is now closing the clinics entirely due to a challenging reimbursement environment and escalating operating costs resulting in a lack of profitability, according to a Tuesday press release. * * *
    • “In the end of Walmart Health illustrates that size alone is not a recipe for success in providing health services, according to Forrester’s Trzcinski. Walmart is the largest retailer in the U.S., with revenue of $648 billion in its most recent fiscal year.
    • “Despite building out the clinics, Walmart didn’t invest in driving adoption, including through digital health and customer experience, Trzcinski said. That caused it to fall behind other retailers that are surging ahead, such as Amazon and CVS.”
  • Per BioPharma Dive,
    • “Eli Lilly raised its revenue forecast for the year by $2 billion as sales of its GLP-1 medicines for diabetes and obesity continue to climb rapidly amid surging demand.
    • “The Indianapolis drugmaker currently can’t make its drugs Mounjaro and Zepbound fast enough, indicating in an earnings statement Tuesday that sales growth will “primarily be a function of the quantity the company can produce and ship.”
    • “Lilly is expanding manufacturing and expects greater capacity in the second half of the year. Revenue from Mounjaro, which is sold for diabetes, totaled $1.8 billion in the first quarter, while Zepbound revenue hit $517 million in its first full quarter on the U.S. market as an obesity treatment.”
  • and
    • “Lilly and Novo [Nordisk] aim to maintain their current hold on the market. Both companies are testing several experimental drugs with the goal of launching oral versions or even more effective treatments than their current products.
    • “Novo is already close to completing a Phase 3 trial program testing an oral form of Wegovy. It also has in late-stage development a combination of Wegovy with a compound called cagrilintide that acts on a gut hormone called amylin.
    • “Lilly has two drugs in Phase 3: an oral GLP-1 dubbed orforglipron that is approaching key data readouts next year and an injectable treatment called retatrutide that stimulates GLP-1, GIP and a third hormone known as glucagon. Results in obesity are due in 2026.
    • “Lilly has four experimental drugs in Phase 1 or 2, while Novo has five.
    • “[Lilly and Novo] cover all the bases,” said Clive Meanwell, CEO of Metsera, a newly launched startup that has two obesity drugs in clinical testing. “Our belief is it’s going to be a portfolio play, with mix and match, with different clinical circumstances and different markets.”
    • The article discusses similar projects from other companies.
  • Beckers Payer Issues reports,
    • “CMS and the NCQA are extending the quality data submission deadline for health plans by two weeks due to “extraordinary circumstances” caused by the cyberattack on Change Healthcare in late February.
    • “Payers will now have until 5pm Eastern Time on June 28 to report their performance on Healthcare Effectiveness Data and Information Set (HEDIS) measures to the two organizations, according to an April 29 memo from CMS. * * *
    • “The Change Healthcare cyberattack has created unprecedented challenges to healthcare organizations across the country,” Eric Schneider, MD, EVP, Quality Measurement and Research Group at NCQA, said in a statement to Becker’s. “This disruptive incident, falling in the middle of the substantial effort and commitment required for quality reporting efforts, has significantly strained resources. Recognizing these extraordinary circumstances and in alignment with CMS, we are granting a deadline extension for the submission of HEDIS Measurement Year 2023 results.” 

Weekend Update

David Ermer–Congress, Mental health care, Rx coverage, U.S. Healthcare–

From Washington DC,

From the public health and medical research front,

  • The New York Times reports
    • “Federal regulators on Friday said that they had not yet discovered live bird flu virus in the first batch of retail milk samples they tested, a reassuring indication that the milk on store shelves remains safe despite an outbreak of the virus among dairy cows.
    • “In an online update, the Food and Drug Administration said an initial set of tests looking for live virus, not just genetic fragments, suggested that the pasteurization process was effectively neutralizing the pathogen.
    • “These results reaffirm our assessment that the commercial milk supply is safe,” the F.D.A. wrote in the update, adding that the testing efforts were ongoing.
    • “Officials also tested infant and toddler formula, which incorporate powdered dairy, and did not find the virus, the agency wrote.”
  • The National Institutes of Health announced yesterday,
    • “A dose-sparing intradermal mpox vaccination regimen was safe and generated an antibody response equivalent to that induced by the standard regimen at six weeks (two weeks after the second dose), according to findings presented today at the European Society of Clinical Microbiology and Infectious Diseases Global Congress in Barcelona. The results suggest that antibody responses contributed to the effectiveness of dose-sparing mpox vaccine regimens used during the 2022 U.S. outbreak(link is external).”
  • The New York Times explains how our country can improve the rate of vaccinations against Hepatitis C.
    • “Dr. Francis Collins, who headed the National Institutes of Health for decades until retiring in 2021, has been spearheading a White House initiative aimed at eliminating the disease.
    • “In an interview, he said he was motivated by memories of his brother-in-law, Rick Boterf, who died of hepatitis C just before the introduction of the new cures. An outdoorsman, Mr. Boterf endured five years of liver failure waiting for a transplant, and even that procedure wasn’t enough to save him from the destructive virus.
    • “The more I looked at this, the more it just seemed impossible to walk away,” Dr. Collins said.
    • The initiative, which was included in President Biden’s latest budget proposal, calls for about $5 billion to establish a five-year “subscription” contract. The federal government would pay a flat fee and, in return, receive drugs for every patient it enrolled for treatment. * * *
    • “Dr. Collins acknowledged that on its own, a national drug-purchasing agreement like Louisiana’s would not be sufficient to turn the tide.
    • “Anybody who tries to say, ‘Oh, it’s just the cost of the drug, that’s the only thing that’s gotten in the way,’ hasn’t looked at those lessons carefully,” he said. To that end the proposal also calls for a $4.3 billion campaign to raise awareness, train clinicians and promote treatment at health centers, prisons and drug treatment programs.”
  • The New York Times offers an in-depth look at anti-depressant medications. Here’s why an in-depth look is useful reading.
    • “Antidepressants are among the most prescribed medications in the United States. This is, in part, because the number of people diagnosed with depression and anxiety has been on the rise, and prescriptions jumped sharply among some age groups during the pandemic.
    • “Despite the prevalence of these medications, some patients have “significant misconceptions” about how the drugs work, said Dr. Andrew J. Gerber, a psychiatrist and the president and medical director of Silver Hill Hospital in New Canaan, Conn.
    • “About 80 percent of antidepressants are prescribed by primary care doctors who have not had extensive training in managing mental illness.
    • “Dr. Paul Nestadt, an associate professor of psychiatry at the Johns Hopkins School of Medicine, said patients tell him, “‘You know, Doc, I’ve tried everything.’” But often, he said, “they never got to a good dose, or they were only on it for a week or two.”

Friday Factoids

David Ermer–ACA, CDC, COVID-19, COVID-19 vaccine, Generative AI, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Perhaps the most convoluted provision in the Affordable Care Act is its individual non-discrimimination clause, Section 1557. The Obama Administration issued an implementing rule. The Trump Administration replaced the Obama Administration’s rule, and today the Biden Administration has replaced the Trump Administration rule.
    • Of note, “[f]or the first time, the Department will consider Medicare Part B payments as a form of Federal financial assistance for purposes of triggering civil rights laws enforced by the Department, ensuring that health care providers and suppliers receiving Part B funds are prohibited from discriminating on the basis of race, color, national origin, age, sex and disability.”
    • HHS will refer FEHB and FEDVIP complaints to OPM.
  • The Washington Post reports,
    • “Medtronic said Friday that the U.S. Food and Drug Administration has approved a new spinal-cord implant that relieves chronic pain, a bid to expand into a patient population that relies heavily on medications like opioids.
    • “The new device works by delivering an electrical pulse to the spinal cord, interrupting pain signals before they reach the brain in patients suffering from back, cervical and nerve damage. While earlier versions of the device provided a constant level of stimulation, Medtronic’s new product can read signals from nerve fibers and automatically adjust the intensity — a feature designed to avoid uncomfortable jolts when a patient sneezes, coughs or laughs.
    • “It’s like listening for whispers at a rock concert,” David Carr, a Medtronic vice president, said in an interview. * * *
    • “Medtronic’s Inceptiv contains a lithium battery that can be recharged through the skin, and two leads with electrodes — some to read the signals from nerve fibers, and others to deliver the electrical pulse. The device can adjust the level of stimulation 50 times a second, according to the company.
    • “Inceptiv is “the world’s smallest and thinnest fully implantable” spinal-cord stimulator, Medtronic said.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration on Friday approved a new gene therapy for hemophilia, clearing Pfizer’s Beqvez for certain people with the less common “B” form of the bleeding condition.
    • “Beqvez is for adults with moderate to severe hemophilia B who currently use drugs to prevent bleeds or have repeated, spontaneous bleeding. Eligible individuals also must be tested to determine whether they have antibodies that neutralize Beqvez’s effects.
    • “Pfizer set the treatment’s list price at $3.5 million, a company spokesperson confirmed. That matches the cost of Hemgenix, the other available gene therapy for hemophilia B. Pfizer will offer insurers a warranty providing “financial protections” if Beqvez doesn’t work or its effects don’t last, the spokesperson wrote in an email, without providing details.”

From the public health and medical research front,

  • The Centers for Disease Control lets us know today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare continues to decrease across most areas of the country. This week, 0 jurisdictions experienced high activity compared to 1 jurisdiction experiencing high activity the previous week. No jurisdictions experienced very high activity. 
    • “Nationally, emergency department visits with diagnosed influenza are decreasing. Emergency department visits with COVID-19 and RSV remain stable at low levels.  
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week. 
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, remains low.” 
  • American Hospital Association News adds,
    • “Adults age 65 and older are encouraged to receive an updated dosage of the COVID-19 vaccine, the Centers for Disease Control and Prevention announced April 25. The update provides protection against the JN.1 and other circulating variants of the virus, and should be administered at least four months following the previous dosage. The CDC’s Advisory Committee on Immunization Practices recommended the additional dose in February.”
  • On a related note, the CDC reports today
    • H5N1 bird flu is widespread in wild birds worldwide and is causing outbreaks in poultry and U.S. dairy cows with one recent human case in a U.S. dairy worker.
    • While the current public health risk is low, CDC is watching the situation carefully and working with states to monitor people with animal exposures.
    • CDC is using its flu surveillance systems to monitor for H5N1 activity in people.
  • Medscape tells us,
    • “The glucagon-like peptide 1 (GLP-1) receptor agonist semaglutide (Wegovy) not only induced weight loss but also improved knee pain in people with knee osteoarthritis (OA) and obesity, according to results from the STEP 9 study reported at the World Congress on Osteoarthritis (OARSI 2024).
    • “From baseline to week 68, the mean change in knee pain assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score was a reduction of 41.7 points for semaglutide and a decrease of 27.5 points for a matching placebo. The estimated treatment difference of 14.1 points between the groups was statistically significant (P < .001).
    • “As for weight loss, this also fell by a significantly greater amount in the people treated with semaglutide vs those given placebo, with respective reductions of 13.7% and 3.2% from baseline, with an estimated 10.5% greater weight loss with semaglutide.
    • “The interesting thing is whether there’s a specific action of GLP-1 receptor agonists on the joint, not through the weight loss but by itself,” principal study investigator Henning Bliddal, MD, DMSc, told Medscape Medical News ahead of reporting the results at OARSI 2024.”
  • The National Institutes of Health (“NIH”) Director writes in her blog,
    • “In Alzheimer’s disease, a buildup of sticky amyloid proteins in the brain clump together to form plaques, causing damage that gradually leads to worsening dementia symptoms. A promising way to change the course of this disease is with treatments that clear away damaging amyloid plaques or stop them from forming in the first place. In fact, the Food and Drug Administration recently approved the first drug for early Alzheimer’s that moderately slows cognitive decline by reducing amyloid plaques. Still, more progress is needed to combat this devastating disease that as many as 6.7 million Americans were living with in 2023.
    • Recent findings from a study in mice, supported in part by NIH and reported in Science Translational Medicine , offer another potential way to clear amyloid plaques in the brain. The key component of this strategy is using the brain’s built-in cleanup crew for amyloid plaques and other waste products: immune cells known as microglia that naturally help to limit the progression of Alzheimer’s. The findings suggest it may be possible to develop immunotherapies—treatments that use the body’s immune system to fight disease—to activate microglia in the brains of people with Alzheimer’s and clear amyloid plaques more effectively.
    • In their report, the research team—including Marco Colonna , Washington University School of Medicine in St. Louis, and Jinchao Hou, now at Children’s Hospital of Zhejiang University School of Medicine in Zhejiang Province, China—wrote that microglia in the brain surround plaques to create a barrier that controls their spread. Microglia can also destroy amyloid plaques directly. But how microglia work in the brain depends on a fine-tuned balance of signals that activate or inhibit them. In people with Alzheimer’s, microglia don’t do their job well enough.  * * *
    • [O]verall, these findings add to evidence that immunotherapies of this kind could be a promising way to treat Alzheimer’s. This strategy may also have implications for treating other neurodegenerative conditions characterized by toxic debris in the brain, such as Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and Huntington’s disease. The hope is that this kind of research will ultimately lead to more effective treatments for Alzheimer’s and other conditions affecting the brain.
  • NIH announced
    • “One injected dose of an experimental malaria monoclonal antibody was 77% effective against malaria disease in children in Mali during the country’s six-month malaria season, according to the results of a mid-stage clinical trial. The trial assessed an investigational monoclonal antibody developed by scientists at the National Institutes of Health (NIH), and results appear in The New England Journal of Medicine.
    • “A long-acting monoclonal antibody delivered at a single health care visit that rapidly provides high-level protection against malaria in these vulnerable populations would fulfill an unmet public health need,” said Dr. Jeanne Marrazzo, director of the National Institute of Allergy and Infectious Diseases, part of NIH.”
  • and
    • “In a new analysis of genetic susceptibility to kidney cancer, an international team of researchers has identified 50 new areas across the genome(link is external) that are associated with the risk of developing kidney cancer. These insights could one day be used to advance our understanding of the molecular basis of kidney cancer, inform screening efforts for those at highest risk, and identify new drug targets. The study was led by scientists at the National Cancer Institute (NCI), part of the National Institutes of Health (NIH).”

From the U.S. healthcare business front,

  • Berkeley Public Health informs us,
    • “Does paying more to have your outpatient surgery done at a hospital, rather than at a freestanding surgical center, lead to better care? A new study led by James C. Robinson, professor of health economics at UC Berkeley School of Public Health, says no.
    • “In an investigation published in the April issue of The American Journal of Managed Care, Robinson and his team found that the higher prices typically charged by hospitals for four common surgeries were not justified by higher quality, as measured by the rate of post-surgical complications.
    • “The researchers analyzed more than 2 million national Blue Cross Blue Shield insurance claims from 2019-2020 for patients aged 18 to 65 who received a colonoscopy, knee or shoulder arthroscopy, or cataract removal surgery, and calculated the prices and rates of complications for each procedure.
    • “They found large differences in price, but very little difference in the rate of post-surgery complications.”
  • Health IT Analytics tells us about the top twelve ways that artificial intelligence will be used in healthcare.
  • HR Dive offers a tracker of state and local laws requiring employers to disclose pay or pay ranges.
    • “Pay disclosure laws have taken several forms. Some require employers to provide the minimum and maximum pay, or a pay range, for a given job upon the request of an applicant. Others mandate this practice without requiring candidates to ask first. The latest wave of laws now require employers to include this information in all applicable job postings.”
  • Per Biopharma Dive,
    • “U.S. Humira sales fell 40% year over year during the first three months of 2024, to about $1.8 billion, as biosimilar copycats put pressure on AbbVie’s top-selling drug, the company said Friday in its first quarter earnings report.
    • “The declines were “in line” with what the company had anticipated for its inflammatory disease drug, AbbVie commercial chief Jeffrey Stewart said in a call with investors. Humira now faces 10 copycat competitors in the U.S., the first of which launched Jan. 31, 2023.
    • “Stewart said the company also expected a recent decision by CVS Health, whose pharmacy benefit manager is the country’s largest by prescription claims, to remove Humira from its national pharmacy effective April 1. Although that has meant Humira’s market share dropped from 96% to 81% over two weeks, Stewart said some of the shift went to other branded medicines, like AbbVie’s products Skyrizi and Rinvoq.”
  • Beckers Payer Issues points out,
    • Centene reported nearly $1.2 billion in net income in the first quarter and a more than 18% decrease in Medicaid membership year over year, according to its first-quarter earnings posted April 26.
    • Total revenues in the first quarter were $40.4 billion, up 3.9% year over year.
    • Total net earnings in the first quarter were nearly $1.2 billion, up 2.9% since the same period last year.
    • The company raised its year-end adjusted EPS guidance to at least $6.80.
    • The company’s medical loss ratio was 87.1% in the first quarter and 87% during the same period last year.”
  • According to Fierce Healthcare,
    • “The new year is “off to a good start,” for Community Health Systems, which reported a somewhat narrowed $41 million net loss (-$0.32 per diluted share) and a solid uptick in operating revenues for its first quarter.
    • “The 71-hospital for-profit system had logged a $51 million net loss during the same period last year, which, at the time, CHS attributed to a bump in Medicare Advantage patient volume.
    • “After excluding adjustments related to impairment losses and business transformation costs, the company landed at a net loss of $0.14 per share, which was about in line with consensus estimates.
    • “However, CHS shared a rosier picture when it came to operating revenues. Its three-month net of $3.14 billion beat estimates by about $50 million and was a 1% increase over last year.”
  • Healthcare Dive reports,
    • “Universal Health Services delivered first quarter earnings results Wednesday that beat analysts’ estimates on stronger than expected revenue and volume metrics across its behavioral health and acute service lines.”Universal Health Services delivered first quarter earnings results Wednesday that beat analysts’ estimates on stronger than expected revenue and volume metrics across its behavioral health and acute service lines.
    • “UHS increased its same facility net revenues for its acute care and behavioral care service lines by 9.6% and 10.4%, respectively, during the first quarter of 2024 compared to the same period last year.
    • “However, the operator could suffer a “material” financial hit should the operator fail to lower a March $535 million judgment against a subsidiary, UHS disclosed in its earnings report. The for-profit health system is currently appealing the judgment in post-trial motions, said CFO Steve Filton during the earnings call.”

Tuesday Tidbits

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Federal News Network lets us know,
    • “Enrollees in the Federal Employees Health Benefits (FEHB) program just began seeing better coverage of in-vitro fertilization (IVF) for the first time this year. But some members of Congress are looking to take things a step further.
    • “More than 175 House and Senate Democrats are urging the Office of Personnel Management to require every FEHB carrier to expand their offerings and cover costs for both infertility treatments and medications, starting in plan year 2025.
    • “That requirement “would reflect the reality that IVF is one of the most effective treatments for families struggling with infertility, and growing in popularity, with its usage nearly doubling from 2012 to 2021,” the lawmakers, led by Rep. Gerry Connolly (D-Va.) and Sen Tammy Duckworth (D-Ill.), wrote in a letter to OPM Tuesday.”
  • The Congressional letter does not reflect the fact that at least one option of many large FEHB plans do cover IVF treatments and likely more plans will offer that coverage for 2025 due to competition because growing families are good FEHB customers.
  • The Department of Health and Human Services released the 2024 National Strategy for Suicide Prevention (National Strategy) and accompanying Federal Action Plan. * * * To learn more about the 2024 National Strategy for Suicide Prevention and Federal Action Plan, visit www.hhs.gov/nssp.”
  • The Food and Drug Administration announced,
    • “a new initiative aimed to help reimagine the home environment as an integral part of the health care system. The Home as a Health Care Hub is intended to enable solutions that seamlessly integrate medical devices and health care, prevention and wellness into people’s lives and may: 
      • “Help medical device developers consider novel design approaches. 
      • “Aid providers to consider opportunities to extend care options and educate patients.
      • “Generate discussions on value-based care paradigms.
      • “Open opportunities to bring clinical trials and other evidence generation processes to underrepresented communities.”
  • The American Hospital Association News tells us,
    • “The Federal Trade Commission April 23 voted 3-2 to issue a final rule that would ban as an unfair method of competition contractual terms that prohibit workers from pursuing certain employment after their contract with an employer ends. The final rule does not apply to existing agreements with executives earning more than $151,164 annually who are in policymaking positions. In addition, although the Commission recognized that it does not have jurisdiction over not-for-profit entities, it reserved the right to evaluate an entity’s non-profit status and noted that some “entities that claim tax-exempt nonprofit status may in fact fall under the Commission’s jurisdiction.” Specifically, it stated that “some portion of the 58% of hospitals that claim tax-exempt status as nonprofits and the 19% of hospitals that are identified as State or local government hospitals in the data cited by AHA likely fall under the Commission’s jurisdiction and the final rule’s purview.”
    • “The rule takes effect 120 days after publication in the Federal Register and includes model language that employers can use to communicate to workers.  The United States Chamber of Commerce has already indicated that it will file suit to challenge the final rule.”
  • Healthcare Dive adds
  • HR Dive notes,
    • “The U.S. Department of Labor said Tuesday it will publish a final rule raising the Fair Labor Standards Act’s minimum annual salary threshold for overtime pay eligibility in a two-step process. Starting July 1, the threshold will increase from $35,568 to $43,888 per year. It will then increase to $58,656 on Jan. 1, 2025.
    • “The changes will expand overtime pay eligibility to millions of U.S. workers, the agency said. DOL’s 2025 threshold represents a jump of about 65% from the Trump administration’s 2019 rule and is slightly higher than the $55,068 mark that DOL proposed in 2023.
    • “The threshold will automatically update every three years using current wage data — which would next occur on July 1, 2027 —  but DOL said in the proposed rule that updates may be temporarily delayed if the department chooses to engage in rulemaking to change its methodology or update mechanism.”
  • Per FedWeek,
    • “The inspector general’s office at OPM has posted a warning against calling a phone number once associated with the agency’s Employee Express FEHB enrollment site (888-353-9450), saying the number “is currently in use by fraudsters/bad actors who have practiced financial exploitation tactics.”
    • “This phone number was provided on U.S. Department of State human resources notices to employees and Foreign Service retirees. It may also be or have been provided on other participating federal agencies’ human resources or information. This customer service phone number is no longer in use by OPM or the federal government,” it says.”

From the public health and medical research front,

  • The Wall Street Journal reports, “Removing ovaries with a hysterectomy might increase risk of heart disease, stroke and dementia.”
    • “A removal of the ovaries before menopause and before age 46 years may cause an acceleration of the aging processes across many organs, for example, the brain, and many tissues of the body, for example, the bones,” says Dr. Walter Rocca, who is a professor of epidemiology and neurology at the Mayo Clinic in Rochester, Minn., and has written studies on the topic. * * *
    • “Rocca was co-author of a 2021 Jama Network Open study that found that women under 46 who removed both of their ovaries with or without a hysterectomy had an increased risk of mild cognitive impairment and performed worse on cognitive tests 30 years later compared with women who didn’t undergo the procedure.
    • “Another study Rocca co-wrote found that women who had ovaries removed before age 50 faced higher risks for several conditions years later, including heart disease and osteoporosis.
    • Other studies have linked the procedures to an increased risk of dementia, Parkinson’s disease and accelerated aging.
    • “Sometimes, patients push to have their ovaries out at a younger age to help with symptoms such as pelvic pain or to avoid a subsequent surgery, says Dr. Daniel Breitkopf, chair of OB-GYN at Mayo Clinic and a member of ACOG’s board of directors. He usually advises waiting.
    • “I would rather do an oophorectomy five or 10 years later so then we have five to 10 years of benefit of those ovaries on your health,” he says.” 
  • The Washington Post informs us,
    • “Viral fragments of bird flu have been identified in samples of milk taken from grocery store shelves in the United States, a finding that does not necessarily suggest a threat to human health but indicates the avian flu virus is more widespread among dairy herds than previously thought, according to two public health officials and a public health expert who was briefed on the issue.
    • “The Food and Drug Administration said Tuesday that it had been testing milk samples throughout the dairy production process and confirmed the detection of viral particles “in some of the samples,” but it declined to provide details.
    • “The presence of genetic fragments of the virus in milk is not unexpected. Pasteurization typically works to inactivate pathogens, said Jennifer Nuzzo, director of the Pandemic Center at the Brown University School of Public Health. It generally does not remove genetic material, Nuzzo said, but typically renders pathogens unable to cause harm to people.”
    • “The greater concern, however, “is that it’s showing up in a lot more samples, meaning the infection is more widespread in dairy herds than we thought,” said one public health official, who spoke on the condition of anonymity to share information not yet made public.”
  • STAT News tells us,
    • “Day One Biopharmaceuticals said Tuesday the Food and Drug Administration gave accelerated approval to its targeted pill for one of the most common forms of childhood brain tumors, pediatric low-grade glioma.
    • “The weekly pill, previously known as tovorafenib, will be marketed as Ojemda. These tumors generally regress when patients become adults, but toxic treatments are often needed to keep them at bay until then. The hope is that Ojemda can spare some children from, for example, radiation, which can devastate tumors but also healthy tissue throughout the brain and bring lifelong consequences.  * * *
    • “Day One plans to release a price Wednesday morning. 
    • “The authorization is particularly notable because industry has historically developed few drugs for children with cancer, instead focusing on adults, where there is a larger market.” 
  • Per BioPharma Dive,
    • “Neurocrine Biosciences, a drugmaker focused on the brain and nervous system, said Tuesday that one of its experimental medicines succeeded in a clinical trial evaluating it as a treatment for major depression.
    • “The medicine hit the Phase 2 trial’s main goal as well as “key secondary endpoints,” according to Neurocrine, which plans to meet with the Food and Drug Administration to discuss a path to late-stage testing. If positive results continue to pile up, the medicine could become the first of its kind to secure an approval.
    • “Eiry Roberts, Neurocrine’s chief medical officer, called the newly released data “very encouraging” and reflective of the medicine’s potential to alleviate many of the symptoms associated with major depressive disorder.”
  • HealthDay relates,
    • “The dangerous heart rhythm disorder called atrial fibrillation is becoming more common in middle-aged people, a new study warns.
    • “More than a quarter of patients at the University of Pittsburgh Medical Center (UPMC) seeking care for A-Fib during the last decade were younger than 65, researchers found.
    • “That’s much higher than the 2% prevalence of A-Fib commonly estimated among non-seniors, researchers said.
    • “Common knowledge among cardiologists is that, in people under 65, A-Fib is extremely uncommon and not detrimental. But there really hasn’t been any data to back that up,” said lead researcher Dr. Aditya Bhonsale, a UPMC cardiac electrophysiologist.
    • “The study also found that younger patients with A-Fib were more likely to die or to be hospitalized for heart failure, stroke or heart attack.”
  • Medscape discusses four recently FDA approved therapies that “are likely to be particularly important for primary care clinicians.” 

From the U.S. healthcare business front,

  • Health Payer Intelligence reports,
    • “Provider markups on specialty drugs increased 2024 commercial health insurance premiums by $13.1 billion, according to research from Oliver Wyman commissioned by AHIP.
    • “Provider-administered drugs can be delivered directly to providers from a specialty pharmacy—known as white bagging—or providers can purchase the drugs from the manufacturer or distributor and store the drug until the patient needs it, also called buy and bill.
    • “In the buy-and-bill method, hospitals and physicians can add a markup to the drug, which patients are responsible for paying. Delivering drugs through white bagging is generally more affordable for patients and payers because pharmacies do not add markup charges.
  • mHealth Intelligence relates, “Though telehealth utilization resulted in improvements in some healthcare utilization and quality measures, it was also linked to a 1.6 percent increase in healthcare spending, according to new research published in Health Affairs.”
  • STAT News adds,
    • “In the early days of the pandemic, as social distancing forced patients out of doctors’ offices, health care organizations scrambled to offer care online. In turn, health care accreditation organizations rushed to tweak their standards, filling a void in best practices for virtual visits.
    • “But as telehealth has matured, accreditation bodies — typically nonprofits that offer a seal of approval to organizations that pass their audits — are trying to address the nuance of digital care head-on. Today, the Joint Commission announced a new telehealth accreditation that will launch on July 1. Later that month, the National Committee for Quality Assurance plans to release its own virtual care standards, with applications for a new accreditation opening in November.”
  • The Institute for Clinical and Economic Review (ICER) announced,
    • ICER and NEWDIGS at Tufts Medical Center “have collaborated to publish a new white paper today that provides clear policy and market solutions to help manage the challenges of paying for gene therapies. The paper, entitled, “Managing the Challenges of Paying for Gene Therapy: Strategies for Market Action and Policy Reform,” was developed with input from a diverse set of patient advocacy groups, payer organizations, large and small biopharmaceutical manufacturers, providers, and others.”
    • “The specific policy reforms and market-based tools ICER and NEWDIGS identify in the paper are intended to help the US health system address these challenges to achieve more equitable and affordable access for patients to the growing number of gene therapies expected to be approved in the coming years. Options such as value-based pricing, value-based outcomes contracts, warranties, subscription insurance models, installment payment arrangements, and a federal carve-out benefit program are explored. For each option, the white paper analyzes the relative advantages and potential unintended consequences, along with suggestions for implementation, and an exploration of unique opportunities for combination or layered approaches.
    • “Gene therapies have the possibility to transform thousands of lives, but only if we ensure sustainable access to them for all patients,” said Sarah K. Emond, MPP, President and CEO of ICER. “It is incumbent upon the entire health care system to focus on innovative payment solutions that can address the challenges of paying for high-cost, one-time treatments. This paper should help stakeholders understand the menu of options available to move beyond responding to the high costs with reduced access, while meaningfully addressing the concerns around clinical uncertainty and budget impact.”
    • “Each condition, therapy and payer is unique, so a single solution cannot satisfy all situations,” said Mark Trusheim, Strategic Director of NEWDIGS. “With a menu of options which can be combined in a single contract or assembled from existing market offerings, each community can construct the most effective approach to ensuring appropriate patient access in their area.”
  • Reuters reports,
    • “Eli Lilly (LLY.N), said on Monday that it will acquire a manufacturing facility from Nexus Pharmaceuticals to produce injectable medicines.
    • “Lilly expects production at the facility based in Pleasant Prairie, Wisconsin, to begin at the end of 2025.”
    • “Soaring demand for GLP-1 agonists, a class of highly effective diabetes and obesity drugs which suppress appetite and promote a feeling of fullness, has led to constrained supply for drugmakers such as Lilly and Danish drugmaker Novo Nordisk.”
  • Beckers Payer Issues lets us know,
    • “A merger between Humana and Cigna could still be in the cards according to one analyst, Bloomberg reported April 22. 
    • “The math now works for a [Cigna and Humana] fusion,” Jeffries analyst David Windley wrote April 22. Since the two companies abandoned a proposed merger in December, Cigna’s stock prices have risen by 37% and Humana is down 31%, according to Bloomberg. 
    • “Cigna could strike a deal to acquire Humana for around $420 per share, Mr. Windley wrote in a note to clients. An acquisition would add to Cigna’s growth if it does not pay more than $470 per share for the company, according to Jeffries.” 
  • Per Fierce Healthcare,
    • “About a week ago, cybersecurity experts identified posts from the criminal group RansomHub that suggested the data from the Change Healthcare hack was up for sale.
    • “Those listings have since been pulled, according to a twitter post from Brett Callow, a threat analyst at Emsisoft. It’s unclear at present what led the group to suspend the sale, as they were seeking an additional ransomware payout from Change’s parent company UnitedHealth Group.”

Thursday Miscellany

David Ermer–CDC, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The U.S. National Guard Association informs us,
    • “More than 100,000 drilling National Guardsmen and Reservists who are full-time federal employees would be eligible to purchase TRICARE Reserve Select health care under legislation introduced in both the House and Senate last week.
    • “Most drilling Guardsmen and Reservists have been able to buy low-cost TRS for more than 15 years. But the 2008 law that created the current program excluded these service members from the more-expensive Federal Employees Health Benefits program. This exclusion includes the Guard and Reserve’s dual-status technicians. And while a provision in the fiscal 2020 National Defense Authorization Act lifts this prohibition, the change does not take effect until 2030.
    • “The Servicemember Healthcare Freedom Act of 2024 would allow federal employees to enroll in TRS once the legislation is enacted. The bill was introduced by Sen. Richard Blumenthal, D-Conn., and co-sponsored by Sens. Kyrsten Sinema, I-Ariz., Tina Smith, D-Minn., and John Fetterman, D-Pa., in the Senate. Reps. Jen Kiggans, R-Va., and Andy Kim, D-N.J., introduced the measure in the House. Kim is the Democratic co-chair of the House National Guard and Reserve Caucus.
    • “The legislation affects roughly 113,000 Guardsmen and Reservists, according to a fact sheet from Blumenthal’s office. This figure includes approximately 67,000 Guard and Reserve dual-status technicians, who must be drilling service members to maintain their full-time employment.
    • “Cost is often the big difference between TRS and FEHBP. For example, the widely used FEHBP Blue Cross Basic Option costs $150 a month for a single adult, per Blumenthal’s office. The same TRS coverage is $51.95 a month. The average family of four spent $657.04 each month on health care though FEHBP last year, according to the same fact sheet. Family plans through TRS cost $246.87 a month. * * *
    • “TRS also provides continuity of care during service members’ mobilizations and demobilizations.”
  • The Office of Personnel Management issued a press release about a “New Benefits Administration Letter to Promote the Integrity of the Federal Employees Health Benefits Program.” This was the action discussed in Federal Times and Federal News Network articles that the FEHBlog discussed yesterday. The press release adds,
    • “OPM has proposed legislation in its FY2025 Congressional Budget Justification which would enable OPM consistent access to funds from the Employee Health Benefits Fund to build a Central Enrollment system for the FEHB Program. Current FEHB eligibility determination and enrollment is highly decentralized and requires cooperation between nearly 100 employing offices responsible for determining eligibility and enrolling more than 8 million members. These benefits are delivered by 68 health insurance carriers in 2024.     
    • “Since 2022, and following passage of the Postal Service Reform Act, OPM began developing the Postal Service Health Benefits Program to include a centralized enrollment platform. The PSHB accounts for more than 20 percent of current FEHB enrollees. If funded, OPM could extend this same central enrollment system to all FEHB enrollments, which would allow OPM to manage and make consistent all FEHB enrollments and remove individuals who cease to be eligible for the program. ”   
  • OPM also should provide carriers with HIPAA 820 electronic enrollment rosters to systematically reconcile premiums to individual enrollees, thereby assuring that each enrollee is paying the appropriate premium.
  • WTW, a major consulting firm, posted an article about the final 2025 notice of benefits and payment parameters which calls attention to a point on which the FEHBlog has not yet focused.
    • CMS adopted a rule to remove the regulatory prohibition on issuers from including routine non-pediatric dental services as an essential health benefit (EHB). This change would allow states to update their EHB-benchmark plans to add routine adult dental services as an EHB, removing regulatory and coverage barriers to expanding access to adult dental benefits. 
    • If a self-insured [or any FEHB] plan adopts a state benchmark plan that covers non-pediatric dental as an EHB and that plan covers non-pediatric dental, then the plan could not impose annual or lifetime dollar limits on that coverage (unless the coverage meets the requirements to be an excepted benefit or limited scope dental).
  • The American Hospital Association News reports,
    • “The Federal Trade Commission, Justice Department and Department of Health and Human Services April 18 launched HealthyCompetition.gov, an online portal for the public to report potentially unfair and anticompetitive health care practices. The FTC and the Justice Department’s Antitrust Division plan to review complaints for the appropriate agency to investigate if it raises sufficient concern under antitrust laws or HHS authorities.”
  • HR Dive tells us,
    • “The U.S. Supreme Court held Wednesday that employees challenging discriminatory transfers at work do not need to prove they suffered “significant” harm under Title VII of the Civil Rights Act of 1964; instead, they need only prove harm was done. 
    • “To demand ‘significance’ is to add words to the statute Congress enacted,” the high court ruled in Muldrow v. City of St. Louis. “It is to impose a new requirement on a Title VII claimant, so that the law as applied demands something more than the law as written. That difference can make a real difference for complaining transferees.”
    • “In the case, a police sergeant alleged she was transferred out of the intelligence division because of her sex and given less “prestigious” duties, a worse schedule and fewer job perks.”
  • The U.S. Census Bureau reports,
    • “The percentage of adults age 65 and older covered by both private health insurance and Medicare decreased from 47.9% in 2017 to 39.6% in 2022, reflecting older adults’ increased reliance on Medicare coverage alone.
    • “Dual coverage rates decreased almost every year during that period, except from 2020 to 2021, while rates of Medicare coverage alone significantly increased during the same period, from 37.6% to 44.8%, according to a new analysis of data from the 2023 Current Population Survey Annual Social and Economic Supplement (CPS ASEC). 
    • “Much of the increase in the share of older adults relying solely on Medicare was driven by a drop in the share of those also receiving private coverage.”
  • Although OPM waited much too long to allow FEHB plans the opportunity to offer Part D EGWPs, OPM to its credit has not followed the lead of many private employers which leave their retirees to Medicare alone.
  • The Social Security Administration has made available an interview with its new Commissioner Martin O’Malley who discussed his top priorities: “1) Reduce call wait times, 2) Issue faster disability decisions, 3) Resolve inequities in overpayments and underpayments.”

From the public health and medical research front,

  • Per MedPage Today,
    • “The CDC and FDA are warning about a multistate outbreak of Salmonella typhimuriumopens in a new tab or window infections linked to fresh basil sold at Trader Joe’s stores in over two dozen states.
    • “Twelve cases have been reported across seven states as of April 17, including one hospitalization. Exposure to fresh organic basil from Trader Joe’s prior to illness was confirmed in seven of eight individuals with additional case information.
    • “Miami-based Infinite Herbs, which makes the basil, has agreed to a voluntary recall, and the herbs have been pulled from store shelves.
    • “If you already bought organic basil from Trader Joe’s and removed it from the packaging or froze it and cannot tell if it was Infinite Herbs-brand, do not eat or use it and throw it away,” the FDA said in its statementopens in a new tab or window.
    • “The product was sold in a 2.5-oz clamshell-style container at Trader Joe’s stores in Washington, D.C., and 29 statesopens in a new tab or window, with most east of the Mississippi River. Cases have been reported in Florida, Georgia, Minnesota, Missouri, New Jersey, Rhode Island, and Wisconsin.
    • “An investigation is ongoing to determine whether additional products are linked to the illnesses, the FDA noted.”
  • The NIH Director, in her blog, pointed out,
    • “Pregnancy and childbirth are often thought of as joyful times. Yet, we know that mental health conditions including perinatal depression, anxiety, and post-traumatic stress disorder (PTSD) are common complications during and after pregnancy, and this is contributing to a maternal health crisis in this country.
    • “Now, a trio of NIH-supported studies reported in the journal Health Affairs show that diagnosis and treatment of mental health conditions such as anxiety, depression, and PTSD during pregnancy and in the first year after giving birth rose significantly in Americans with private health insurance from 2008 to 2020. While these are encouraging signs of increasing mental health awareness and service use, these studies also showed that this increase hasn’t happened equally across all demographic groups and states, making it clear there’s more work to do to ensure that people from all walks of life have access to the care they need, regardless of their race, ethnicity, geographic location, financial status, or other factors. * * *
    • “It will be important to learn in future studies more about those who may still not be receiving the mental health care they need. The researchers report plans to look deeper into changes that have taken place at the state level and the impact of the pandemic and the rise of telehealth since 2020. Other recent NIH-supported research suggests that relatively straightforward interventions to reduce postpartum anxiety and depression can be remarkably effective. The key step will be not only identifying interventions that work, but also figuring out how to deliver effective treatments to the people who need them.”
  • According to BioPharma Dive,
    • “Cerevel Therapeutics, a biotechnology company in the midst of being acquired by AbbVie, on Thursday said a Parkinson’s disease treatment it’s developing succeeded in a late-stage clinical trial.
    • “The treatment, called tavapadon, helped keep the disease’s disruptive motor fluctuations at bay, extending the total time of symptom control by just over one hour, compared to a placebo. This difference in “on” time was statistically significant, Cerevel said.
    • “Tavapadon also significantly reduced the amount of “off” time that treated study participants experienced, meeting a secondary goal of the Phase 3 study. People with Parkinson’s often cycle between these “on” and “off” periods as the effects of mainstay drugs like levadopa and carbidopa wane. In Cerevel’s study, tavapadon was given as an adjunctive therapy, meaning it was added on top of levadopa.”
  • The Washington Post reports,
    • “The nation’s largest coalition of obstetricians issued an urgent warning Thursday calling on doctors to expand testing for syphilis during pregnancy amid a surge of cases in recent years.
    • “The American College of Obstetricians and Gynecologists updated its recommendations, advising a routine blood screening at the first prenatal visit and screenings in the third trimester of pregnancy and at birth. This contrasts with previous recommendations, which called for testing in the third trimester exclusively for individuals living in communities with high syphilis rates and for those at risk of syphilis exposure during pregnancy.
    • “We’re always trying to create healthier families, and some of the diseases that we can easily diagnose and treat are things that we should prioritize, especially when they can be devastating to a baby,” said Laura E. Riley, chair of the obstetrician coalition’s immunization work group. Riley helped write the guidance. * * *
    • “In April 2023, the Food and Drug Administration announced a shortage of penicillin in the United States attributed to increased demand.
    • “To combat the ongoing shortages, the FDA granted temporary approval for a French drug, Extencilline, which is used for syphilis treatment but is not FDA-approved. While the Food, Drug, and Cosmetic Act prohibits importing unapproved drugs into the United States, the secretary of Health and Human Services can authorize temporary importation and distribution of such drugs to address shortages until domestic production returns to normal levels.
    • “Riley said the updated guidance from the obstetricians group is essential because it makes physicians aware of the alternative treatment for syphilis amid the shortage.
    • “In June 2023, the maker of penicillin, Pfizer, said it would prioritize making the drug available, with the shortage expected to be relieved within the next few months of this year.”

From the U.S. healthcare business front,

  • Beckers Payer Issues relates,
    • “Elevance Health posted $2.2 billion in net income during the first quarter, a nearly 13% increase compared to the same period last year, according to the company’s earnings report published April 18.
    • “First quarter results reflect disciplined execution of our strategic initiatives during a dynamic time for our industry,” President and CEO Gail Boudreaux said. “We are making significant progress expanding Carelon’s capabilities, scaling our flywheel for enterprise growth, and delivering results for all stakeholders. Given the solid start to the year, we have increased our outlook for full year earnings.”
    • “Total revenues in the first quarter were $42.6 billion, a 1% increase year over year.
    • “Total expenses in the first quarter were $39.6 billion, a 0.2% increase.
    • “Net income was $2.2 billion in the first quarter, up 12.9% from the same period last year. 
    • “Elevance raised its full-year earnings outlook to $37.20 in earnings per share.”
  • Modern Healthcare lets us know,
    • “CVS Health is opening Oak Street Health primary care clinics at its retail pharmacy stores — a move that hasn’t always worked out for competitors.
    • “CVS acquired primary care provider Oak Street last May for $10.6 billion and announced plans to add 50 to 60 Oak Street clinics in 2024. Most of those clinics are expected to be standalone locations, including some located in closed CVS stores. But CVS also is piloting a setup that replaces much of the retail space in existing stores with clinics.
    • “Walgreens executives say they remain confident in the VillageMD investment, although the focus has shifted away from expansion and more toward ramping up profitability in VillageMD’s strongest markets.
    • “CVS may have a different experience. Its expansion plan for Oak Street has a slower pace than what Walgreens tried, said Jack Slevin, vice president of healthcare services equity research at Jefferies. CVS’ model is dedicating a lot of space to the Oak Street clinics and pharmacy operations, which would allow for more patient volume, he said.
    • “[CVS is] giving them enough space that it feels like a true Oak Street location,” Slevin said. “If you look at the Walgreens strategy on the square footage side, it was very much more bolting on a smaller Village practice to a Walgreens store that was going to look very much the same.”
  • The FEHBlog also ran across the following consulting firm opinion pieces that are worth a gander:
    • A Brown and Brown paper on the role of employers in advancing health equity.
    • A RAND paper discussing why employers delay coverage for FDA newly approved drugs.
      • FEHBlog takeaway :”The FDA has steadily increased the speed at which it approves new drugs over the last two decades. In 2023, the agency approved 55 new drugs, up from 21 in 2003. The great majority of drugs are now approved through its accelerated program, leaving the FDA wide open to criticism that its standards are too low and that it is simply acting as a rubber stamp for pharmaceutical companies. Under the accelerated program, the FDA grants approval for the drug to be put on the market and later grants full approval after clinical trials confirm a drug’s effectiveness.”
    • A McKinsey Health Institute paper on improving mental health services for children.
      • “As part of the McKinsey Health Institute’s (MHI’s) Conversations on Health series, Erica Coe and Kana Enomoto, coleaders at MHI, discussed this challenge and how to prioritize the mental health needs of children and adolescents with Zeinab Hijazi, PsyD, the global lead on mental health at UNICEF.”

Midweek Update

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Federal Times and Federal News Network discuss OPM’s plans to tighten internal controls over family member eligibility in the FEHBP. OPM’s actions will shift the burden of monitoring family member eligibility from the FEHB plans to employing agencies, which is where the responsibility belongs.
  • OPM also should be filling the greatest internal control gap in the FEHB – the fact that OPM does not allow carriers, which bear the insurance risk, to reconcile premium payments to individual enrollees. A cost effective solution is available by implementing the HIPAA 820 electronic enrollment roster transaction which systematically generates such reconciliations.
  • Per BioPharma Dive,
    • “Alvotech and Teva on Tuesday won Food and Drug Administration approval for Selarsdi, the second biosimilar poised to challenge Johnson & Johnson’s blockbuster psoriasis drug, Stelara.
    • “The FDA cleared Selarsdi for treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and children who are at least 6 years old. The companies said they expect to begin selling the medicine on or after Feb. 21, 2025, a delayed introduction due to a legal settlement with J&J.
    • “The two companies are likely to enter the market after Amgen, which won approval for an interchangeable biosimilar called Wezlana in October. Amgen is also subject to a legal settlement, and the company has said its product will launch no later than Jan. 1, 2025.”
  • Healthcare Dive had the time to report on the CBO report on Medicare Accountable Care Organizations which the FEHBlog noted yesterday.
    • “Accountable care organizations led by independent physicians save Medicare more money than other types of ACOs, according to a new Congressional Budget Office review of existing research.
    • “Independent physician-led ACOs have clear financial incentives to reduce hospital care to lower spending, while hospital-led ACOs — which earn more revenue when patients are admitted — do not, the CBO found. Hospitals also have less direct control over what services patients receive.
    • “ACOs with a larger proportion of primary care providers also saved Medicare more money, along with ACOs whose initial spending was higher than their peers in the same region, according to the report.”
  • The FEHBlog’s primary care provider practices in such an ACO.

From the public health and medical research front,

  • The New York Times reports,
    • “A pill taken once a week. A shot administered at home once a month. Even a jab given at a clinic every six months.
    • “In the next five to 10 years, these options may be available to prevent or treat H.I.V. Instead of drugs that must be taken daily, scientists are closing in on longer-acting alternatives — perhaps even a future in which H.I.V. may require attention just twice a year, inconceivable in the darkest decades of the epidemic.
    • “This period is the next wave of innovation, newer products meeting the needs of people, particularly in prevention, in ways that we didn’t ever have before,” said Mitchell Warren, executive director of the H.I.V. prevention organization AVAC.
    • “Long-acting therapies may obviate the need to remember to take a daily pill to prevent or treat H.I.V. And for some patients, the new drugs may ease the stigma of the disease, itself an obstacle to treatment.”
  • STAT News lets us know,
    • “Eli Lilly reported positive results for its obesity drug Zepbound in obstructive sleep apnea, giving the medication a new edge in the highly competitive obesity market.
    • “The results also pave the way for Zepbound to potentially become the first approved treatment for obstructive sleep apnea, or OSA, a common disorder characterized by breathing interruptions during sleep.
    • “In one year-long Phase 3 study that looked at patients with obesity who were not on PAP therapy, a form of ventilation, those taking Zepbound experienced a reduction of 25.3 events per hour on the apnea-hypopnea index (AHI), a measure of the number of times breathing stops and becomes restricted while sleeping. That compares with a reduction of 5.3 events in patients on placebo, Lilly said in a press release Wednesday.
    • “In another Phase 3 study in patients who were on PAP therapy, those on Zepbound had a reduction of 29.3 events per hour on the AHI, compared with a reduction of 5.5 events in patients on placebo.
    • “Severe OSA is defined as having over 30 events per hour, and moderate OSA is defined as 15 to 30 events per hour.”
  • CNBC adds,
    • “Most doses of Eli Lilly’s highly popular weight loss drug Zepbound and diabetes counterpart Mounjaro will be in short supply through the second quarter of this year due to increased demand, according to an update on the Food and Drug Administration’s drug shortage database.
    • “A previous update said some doses of both treatments would have limited availability through April.
    • “The new update suggests that the insatiable demand for a buzzy class of weight loss and diabetes drugs is still trouncing supply, even as Eli Lilly and Novo Nordisk work to increase production of those treatments.” 
  • The Associated Press informs us,
    • “For decades, patients seeking medication for pain have had two choices: over-the-counter drugs like aspirin or powerful prescription opioids like oxycodone.
    • “Opioid prescriptions have plummeted over the last decade as doctors have become more attuned to the risks of addiction and misuse during the country’s ongoing drug epidemic.
    • “Vertex Pharmaceuticals recently reported positive results for a non-opioid painkiller, one of several medications the Boston-based drugmaker has been developing for various forms of pain. Patients taking the drug after surgery experienced more pain relief than those getting a placebo, although the drug didn’t meet a secondary goal of outperforming treatment with an opioid.
    • The AP interviews Vertex’s chief scientist Dr. David Altshuler about the company’s research and development plans.
  • Beckers Hospital Review tells us,
    • “In recent months, parts of the U.S. have reported outbreaks of pertussis, or whooping cough. While some regional outbreaks are expected each year, health officials are underscoring the importance of boosters in adults to protect infants from severe illness, NBC News reported April 17.  * * *
    • “The TDap vaccine is recommended for children 11 and older who have not received the DTaP series. Adults should receive a Tdap booster dose every 10 years, according to the CDC. 
    • “Anyone who comes to see [a] new baby should have had a recent inoculation with Tdap vaccine to provide a cocoon of protection around that baby,” William Schaffner, MD, professor of infectious diseases at Nashville, Tenn.-based Vanderbilt University Medical Center, told NBC News.” 

From the U.S. healthcare business front,

  • Healthcare Dive relates,
    • “Steward Health Care is on the clock. 
    • “The Dallas-based healthcare network has until the end of the month to prove to lenders it has the cash on hand to begin repaying its significant debts — or it could face bankruptcy proceedings. 
    • “Demonstrating solvency could be a tall order because the health system owes a lot of parties a significant amount of money, according to analysts familiar with the system. 
    • “Should Steward fail, it would be one of the largest provider bankruptcies in decades, said Laura Coordes, professor of law at the Sandra Day O’Connor College of Law at Arizona State University.” 
  • MedTech Dive notes, “Abbott looks to ‘highly productive’ device pipeline for future growth. CEO Robert Ford highlighted new and upcoming products throughout the earnings call, calling the recently approved Triclip valve a “billion-dollar opportunity.”
  • According to BioPharma Dive,
    • “An experimental drug designed to improve brain function in people with nerve-degrading disorders has failed a mid-stage study that tested it against Parkinson’s disease.
    • “The trial enrolled almost 90 participants, who once a day were given either a placebo or a drug from Sage Therapeutics called SAGE-718. Summary results released Wednesday showed no significant difference between the two groups in how their mental abilities changed over the course of six weeks, as measured by a scale clinicians use evaluate cognition. * * *
    • “Sage is still testing SAGE-718 across three additional trials that should have data this year. One, codenamed “Lightwave,” is focused on people with mild cognitive impairment and mild dementia due to Alzheimer’s disease. The other two, “Surveyor” and “Dimension,” are investigating whether the drug can help Huntington’s disease patients with cognitive impairment.”
  • Beckers Hospital Review points out and names ten of twenty most popular drugs are in shortage.

OPM Director Resigns

David Ermer–AHRQ, Congress, COVID-19 vaccine, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC,

  • Federal News Network reports,
    • Kiran Ahuja, director of the Office of Personnel Management, will be stepping down from her position in early May, OPM announced Tuesday. * * *
    • Ahuja decided to leave the position due to ongoing health concerns and a recent death in the family, an agency spokesperson said. Once Ahuja vacates her position as the top-most OPM official in the coming weeks, OPM Deputy Director Rob Shriver will begin serving as acting director. * * *
    • “Kiran leaves an incredible legacy as a strong and indefatigable champion of the 2.2 million public servants in the federal workforce,” OPM’s Shriver said in a statement. “Under Kiran’s leadership, OPM has bounced back stronger than ever and partnered with agencies across government to better serve the American people. Kiran represents the very best of the Biden-Harris administration, and I am honored to call her a dear colleague and friend.”
  • Here are links to today’s relevant House of Representatives Committee hearings — one “Examining Health Sector Cybersecurity in the Wake of the Change Healthcare Attack” and the other “ERISA’s 50th Anniversary: the Path to Higher Quality, Lower Cost Health Care.”
  • STAT News reports,
    • “President Joe Biden’s administration will help 50 countries identify and respond to infectious diseases, with the goal of preventing pandemics like the Covid-19 outbreak that suddenly halted normal life around the globe in 2020.
    • “U.S. government officials will offer support in the countries, most of them located in Africa and Asia, to develop better testing, surveillance, communication, and preparedness for such outbreaks in those countries.
    • “The strategy will help “prevent, detect and effectively respond to biological threats wherever they emerge,” Biden said in a statement Tuesday.
    • “The Global Health Security Strategy, the president said, aims to protect people worldwide and “will make the United States stronger, safer, and healthier than ever before at this critical moment.”
  • The Congressional Budget Office issued a report about past performance and future directions of Medicare Accountable Care Organizations.
  • One Digital tells us,
    • “The 2023 EEO-1 Component 1 data collection window opens on April 30, 2024 and ends June 4, 2024. Private-sector employers with 100 or more employees or federal contractors with 50 or more employees must submit workforce demographic data. The EEO-1 Component 1 report is a mandatory annual data collection. Covered employers must submit data by job category and sex and race or ethnicity to the Equal Employment Opportunity Commission (EEOC). Updates to the data collection will be posted to the EEOC’s dedicated EEO-1 Component 1 website.
    • “The 2023 EEO-1 Component 1 Instruction Booklet and 2023 EEO-1 Component 1 Data File Upload Specifications are available on the EEOC’s dedicated EEO-1 Component 1 website. Employers must file their information through the EEO-1 Component 1 Online Filing System (OFS) either through manual data entry or data file upload. The EEO-1 Component 1 online Filer Support Message Center (i.e., filer help desk) will also be available on Tuesday, April 30, 2024, to assist filers with any questions they may have regarding the 2023 collection.”

From the public health and medical research front,

  • Value Penguin lets us know,
    • “Some much-needed good news for U.S. citizens: Between the first quarters of 2021 and 2023, the national age-adjusted death rate fell by 17.7%, according to the latest ValuePenguin study.
    • “Our study also looked at death rates by cause and the leading causes by state. Perhaps unsurprisingly given increased vaccination access and herd immunity, COVID-19 deaths fell most precipitously over that time. Deaths from most other causes showed a decline, too.”
  • HHS’s Agency for Healthcare Quality and Research released a Medical Expenditure Panel Survey with the following highlights
    • “In 2021, the top 1 percent of the population ranked by their healthcare expenditures accounted for 24 percent of total healthcare expenditures, while the bottom 50 percent accounted for less than 3 percent.
    • “Persons in the top 1 percent expenditure tier had an average of $166,980 in healthcare expenditures in 2021, nearly $30,000 higher than in 2019 or 2018. In 2020, persons in the top 1 percent expenditure tier had average expenditures that were more than $20,000 higher than in 2019 or 2018.
    • “Persons aged 65 and older and non-Hispanic Whites were disproportionately represented in the top expenditure tiers. 
    • “Inpatient stays accounted for about 26 percent of healthcare expenses for persons in the top 5 percent expenditure tier.
    • “More than three-quarters of aggregate expenses for persons in the top 5 percent expenditure tier were paid for by private insurance or Medicare.
    • “Among adults in the top 5 percent expenditure tier, 78.1 percent had two or more priority conditions.”
  • MedPage Today relates,
    • “Independent reviewers confirmed a causal relationship between the first mRNA COVID-19 vaccines and myocarditis, and also determined that, more broadly, intramuscular shots can cause a series of shoulder injuries.
    • “At the same time, the National Academies of Sciences, Engineering, and Medicine (NASEM) committee rejected a causal relationship between the Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273 (Comirnaty and Spikevax, respectively) mRNA COVID vaccines and female infertility, Guillain-Barré syndrome, Bell’s palsy, thrombosis with thrombocytopenia syndrome (TTS), and myocardial infarction.”
  • According to the University of Minnesota’s CIDRAP,
    • “A study yesterday in JAMA Internal Medicine demonstrates that 22% of hospitalized adults aged 50 years or older with respiratory syncytial virus (RSV) infection experienced an acute cardiac event—most frequently acute heart failure (16%). Moreover, 1 in 12 of infected patients (8.5%) had no documented underlying cardiovascular disease.
    • “RSV is associated with annual totals of up to 160,000 US hospitalizations, 10,000 deaths, and $4 billion in direct healthcare costs among adults age 65 years or older.
    • “Despite evidence of considerable RSV-associated morbidity, mortality, and health care expenditure, the potential severity of RSV infection in adults has historically been underappreciated by public health professionals and clinicians,” the authors write. RSV is rarely tested for in the clinical settings, and symptoms usually mirror other respiratory diseases, they add.” 
  • and
    • “New research conducted at US primary and urgent care sites shows that antibiotics didn’t provide any benefit for patients with a cough caused by an acute lower respiratory tract infection (LRTI).
    • “In fact, the findings, published yesterday in the Journal of General Internal Medicine, show that receipt of an antibiotic was associated with a small but significant increase in the duration of cough overall compared with those who didn’t receive an antibiotic. Even for those patients with a confirmed bacterial infection, the time until illness resolution was the same whether or not the patients received an antibiotic.
    • “Patients who received an antibiotic also had a higher overall disease severity over the entire course of their illness compared with those who didn’t.
    • “The study authors say the results of the Enhancing Antibiotic Stewardship in Primary Care (EAST-PC) study, which is the largest observational study to date on LRTIs in US primary and urgent care settings, are yet another indication that clinicians should be more prudent about using antibiotics for LRTIs.”
  • BioPharma Dive informs us,
    • “An antipsychotic drug from Intra-Cellular Therapies appears to also work as an add-on therapy for depression, according to clinical trial results the New York-based biotechnology company released Tuesday.
    • “The large trial enrolled almost 500 patients with major depression and hit its main goal as well as “key secondary endpoints,” the company said in a statement. It found that, over a six-week period, depressive symptoms significantly declined in study volunteers given Intra-Cellular’s drug plus antidepressants compared to those given a placebo and antidepressants.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “UnitedHealth estimates costs from the Change Healthcare cyberattack could reach $1.6 billion this year, executives said on Tuesday. However, the managed care giant maintained its full-year earnings guidance, suggesting the financial fallout from the attack on the massive claims clearinghouse may be less serious than feared.
    • “The hit comes from direct response efforts like recovering Change’s clearinghouse platform and paying higher medical costs after its insurance arm suspended some utilization management processes, in addition to the loss of Change’s revenue.
    • “In the first quarter alone, the cyberattack cost UnitedHealth $872 million, according to financial results posted Tuesday.”
  • Beckers Payer Issues adds,
    • “Rising medical cost trends aren’t going down, but they are stabilizing, UnitedHealth Group executives say. 
    • “CEO Andrew Witty told investors April 16 that pent-up demand and increased health system capacity following the COVID-19 pandemic drove rising costs through 2023, but the trend was a “one-off.” 
    • “We don’t see anything like that. We see much more stabilization. We haven’t seen a step-down from that trend, but we certainly see that kind of sustained activity without aggressive acceleration,” Mr. Witty said. 
    • “Every major insurer reported rising costs in the Medicare Advantage population in the last months of 2023. While a few insurers, including Humana and CVS Health, cut their 2024 earnings guidance based on the trend, UnitedHealth Group maintained it can weather the storm. 
    • “The company reported its first-quarter earnings April 16. UnitedHealthcare’s medical loss ratio was 84.3% in the first quarter, compared to 82.2% the year prior and down from 85% in the fourth quarter of 2023.”
  • and
    • “UnitedHealth Group plans to bring Change Healthcare back stronger than it was before it suffered the largest cyberattack in the history of the U.S. healthcare system. 
    • “On an April 16 call with investors, UnitedHealth Group CEO Andrew Witty said it is “important for the country” that UnitedHealth Group owns Change. 
    • “Without UnitedHealth Group owning Change Healthcare, this attack likely would still have happened. It would have left Change Healthcare, I think, extremely challenged to come back,” Mr. Witty said. “Because it is a part of UnitedHealth Group, we’ve been able to bring it back. We’re going to bring it back much stronger than it was before.” 
  • Medscape offers a slideshow on 2023 physician compensation.
  • Beckers Payer Issues notes,
    • “Elevance Health will enter a partnership with private equity firm Clayton, Dubilier & Rice to develop advanced primary care models. 
    • “The joint effort will operate across multiple states and commercial, individual, Medicare and Medicaid markets, according to an April 15 news release. The payer-agnostic platform will serve more than 1 million members, the companies said. 
    • “The deal is financed primarily “through a combination of cash and our equity interest in certain care delivery and enablement assets of Carelon Health,” according to the news release. The two companies did not disclose the financial terms of the deal, and it is not expected to have a material impact on Elevance’s 2024 earnings. 
    • “The partnership will bring together two CD&R assets, digital platform Apree Health and Florida-based provider group Millennium Physician Group, and Carelon Health. Several Carelon Health clinics, part of Elevance Health, will provide care to members with chronic and complex conditions.” 
  • Beckers Hospital Review lets us know,
    • “About nine months after the FDA fully approved an Alzheimer’s drug for the first time, the medicine is trudging through insurance barriers and hesitations from potential patients, the Chicago Tribune reported April 12. * * *
    • “One of its manufacturers, Eisai, predicted 10,000 patients would begin treatment by the end of March. Eisai executives have since backed away from that forecast, but they say sales are increasing, according to the Tribune. 
    • “CMS covers Leqembi, and so do about 75% of commercial plans in the U.S., a spokesperson for the drugmaker said. But, for the upwards of 6 million Americans who are diagnosed with Alzheimer’s disease, the medication has not made a splash as patients worry about side effects and contraindications.”
  • and
    • “Multiple April bankruptcy court filings revealed that Camp Hill, Pa.-based Rite Aid has plans to shutter 53 additional locations across nine states after it filed for Chapter 11 bankruptcy and shared it will close 154 locations last October. 
    • “The “notice of additional closing stores” filings, obtained by Becker’s, revealed the stores are located in Pennsylvania, New Jersey, New York, Ohio, California, Massachusetts, Michigan, Virginia and Maryland.”