Monday Roundup

Rx coverage

Monday Roundup

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday Factoids

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Miscellany

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

From Washington, DC

  • OPM’s proposed supplemental Postal Service Health Benefits Program rule was posted on the Federal Register’s public inspection list today. The proposed rule will be published in the Federal Register tomorrow and the comment deadline will be thirty days thereafter.
  • The American Hospital News informs us,
    • “The Senate Committee on Health, Education, Labor and Pensions May 23 passed legislation that included proposals on mental health and emergency pediatric services during a markup session. The AHA submitted a statement for the hearing, expressing support for the passage of the Dr. Lorna Breen Health Care Provider Protection Reauthorization Act (S. 3679), which would reauthorize grants for health care providers to establish programs offering behavioral health services for front-line workers, as well as a national education and awareness campaign providing health leaders with evidence-based solutions to reduce health care worker burnout. The AHA also expressed support for the bill as a member of the Healthcare Workforce Coalition, which earlier this week sent a letter to Senate HELP Committee leadership.” 
  • and
    • “The AHA praised Congress May 23 for their support and introduction of the bipartisan Hospital Inpatient Services Modernization Act, which would grant a five-year extension to the hospital-at-home program. 
    • “Standing up a H@H program requires logistical and technical work, with an investment of time, staff and money,” AHA wrote in letters to Senate and House leaders. “In addition to being approved for the federal waiver, some providers must navigate additional regulatory requirements at the state level. For some, this whole process could take a year or more to complete before that first patient is seen at home. A longer extension of the H@H program would provide much-needed stability for existing programs to continue providing care to their patients, and it would give time for others to start programs allowing more patients to benefit from this innovative program.” 
  • and
    • “The AHA May 23 submitted statements for a House Ways and Means Subcommittee on Health hearing on challenges for private physician practices, and a House Budget Committee hearing on the budgetary effects of consolidation in health care. For the Ways and Means Committee hearing, AHA noted how physicians are challenged by increased costs, inadequate reimbursements and administrative burdens from public and private insurer practices.”  
  • Healthcare Dive lets us know,
    • “Drugmakers are allowed to limit and impose conditions on pharmaciesthey send discounted drugs to under the 340B program, [the U.S. Court of Appeals for the D.C. Circuit] ruled Tuesday.
    • “The ruling is a win for drug manufacturers, who were previously threatened with fines from the federal government for violating guidance regarding which pharmacies they would send discounted drugs to.
    • “The Court of Appeals upholds a prior District Court ruling, which sided with drugmakers Novartis Pharmaceuticals and United Therapeutics after they sued the HHS in 2021. It’s the latest ruling regarding the controversial 340B drug program — a separate appellate court also ruled with drugmakers early last year.”
  • STAT News tells us,
    • “An independent panel of advisers to the Food and Drug Administration recommended the agency approve Guardant Health’s blood-based colon cancer detection test. If the agency follows the recommendation, it will clear an early hurdle for the test’s broader adoption.
    • “The expert panel spent hours listening to presentations from Guardant, the FDA, and members of the public before voting on the screening test, called Shield. The panel’s nine voting members then voted on whether the test was safe, effective, and whether its benefits outweigh its risks, with eight, six, and seven panelists endorsing those views, respectively.
    • “FDA approval is a requirement for winning coverage from the Centers for Medicare and Medicaid Services, which could be the difference between Guardant’s test becoming widespread — or irrelevant.” 

From the public health and medical research front,

  • MedPage Today relates,
    • “Over the last 2 years, most new cases of mpox in the U.S. occurred in unvaccinated people, and less than 1% occurred in people who were fully vaccinated against the disease, according to CDC data.
    • “Among 32,819 U.S. mpox cases reported to the CDC from May 2022 to May 2024, only 0.8% occurred among people who had received two doses of the mpox vaccine Jynneos, while 75% of cases occurred among unvaccinated people, reported Sarah Anne Guagliardo, PhD, of the CDC’s Mpox National Response Team, and colleagues in the Morbidity and Mortality Weekly Report.
    • “Despite a perceived increase in [mpox] infections among fully vaccinated persons during 2024, this report indicates that, to date, persistent vaccine-derived immunologic response among persons who received the 2-dose vaccine series exists,” the authors wrote.”
  • and
    • “An at-school vaccination program in France significantly increased human papillomavirus (HPV) vaccine coverage, according to results of the PrevHPV cluster randomized trial.
    • “Among girls and boys ages 11 to 14 years, a school-based program offering HPV vaccinations significantly increased median HPV vaccination coverage by an adjusted 5.5 percentage points after 2 months of the intervention, Morgane Michel, PhD, of the Universite Paris Cite, and colleagues reported in JAMA Network Open.
    • “The intervention consisted of three components: free at-school HPV vaccination, education and motivation of adolescents and their parents, and a training program for general practitioners (GPs). “Free HPV vaccination on school premises was the only component that consistently and significantly increased vaccination coverage,” Michel and colleagues wrote.”
  • STAT News observes,
    • “You’d think if there were a vaccine that would prevent tens of thousands of cases of cancer a year, people would want it for themselves and for their kids.
    • “But new data being released Thursday ahead of the annual meeting of the American Society of Clinical Oncology show that just isn’t the case.
    • “The data showed that the vaccine reduced the risk of HPV-related cancers by 56% in men and 36% in women — numbers that actually probably understate the efficacy of the vaccine because participants in this observational study likely got the vaccine too late to prevent all HPV infections. The data were analyzed by researchers led by Jefferson DeKloe, a research fellow at Thomas Jefferson University. * * *
    • “There is not really any debate, at this point, that this vaccine would prevent tens of thousands of cases of cancer a year if it were used more widely. It’s a miraculous product, and we should be using it.”
  • KFF reports
    • “This brief examines disparities in mental health care by race and ethnicity and other factors based on data from the 2023 KFF Racism, Discrimination and Health Survey, a large, nationally representative survey based on responses from over 6,000 adults. The survey provides unique data on access to the health care system and how factors such as racism and discrimination impact these experiences and overall health and well-being. Key findings include:
    • “Among adults who report fair or poor mental health, White adults (50%) are more likely to say they received mental health services in the past three years compared with Black (39%) and Hispanic adults (36%). Across racial and ethnic groups, about half of all adults (53%) who report that they received mental health services said they were very or extremely helpful.
    • “Adults identify cost concerns and scheduling difficulties as primary barriers to mental health care, and Hispanic, Black, and Asian adults disproportionately report additional challenges, such as finding a provider who can understand their background and experiences, lack of information, or stigma or embarrassment. Among adults who received or tried to receive mental health care, Asian (55%), and Black (46%) adults are more likely to report difficulty finding a provider who could understand their background and experiences compared to their White counterparts (38%). Among those who thought they needed mental health care but did not try to find a provider, Hispanic adults are more likely than White adults to say the main reason was they didn’t know how to find a provider (24% vs. 11%) and/or that they were afraid or embarrassed to seek care (30% vs. 18%).
    • “Adults who report unfair treatment or negative experiences with a provider are twice as likely as those without these experiences to say they went without needed mental health care. Four in ten (41%) adults who report they were treated unfairly or with disrespect by a health care provider and about one-third (35%) of adults who say they’ve had at least one negative experience with a health care provider say they did not get mental health services they thought they needed compared to smaller shares of those who do not report these experiences (18% and 15%, respectively).
    • “Reported awareness of the 9-8-8 mental health hotline remains low overall, particularly among Black, Hispanic, and Asian adults. As of Summer 2023, about one in five (18%) adults say they have heard a lot or some about 9-8-8, with Black (16%), Hispanic (11%), and Asian (13%) adults less likely to say they have heard about 9-8-8 than White adults (21%). At the same time, about one in five (21%) adults say they or a family member has ever experienced a severe mental health crisis that resulted in serious consequences such as homelessness, hospitalization, incarceration, self-harm, or suicide, with this share rising to 39% among young (ages 18-29) White adults.”
  • and
    • “Alcohol use disorder (AUD) is often an underrecognized substance use disorder (SUD) despite its substantial consequences. Over half of US adults (54%) say that someone in their family has struggled with an alcohol use disorder, making it the most prevalent non-tobacco substance use disorder. Yet, only one-third of adults view alcohol addiction as a crisis, compared to over half who see opioids as such. Federal data show that 1 in 10 people had an alcohol use disorder in the past year, over 4 in 10 alcohol users report binge drinking in the past month, and per capita alcohol consumption is higher than the decade prior. Treatment rates for alcohol use disorders are notably low, especially for the use of medication, a recommended AUD treatment component. Although the opioid crisis has been declared a public health emergency by the U.S. Department of Health and Human Services since 2017, no similar declaration exists regarding alcohol deaths. However, HHS has set a priority goal of reducing emergency department visits for acute alcohol use, mental health conditions, suicide attempts, and drug overdoses by 10% by 2025.”
  • The Washington Post adds,
    • “More people in the United States say they are using marijuana daily or near daily, compared with people who say they are drinking alcohol that often, according to a new study.
    • “In 2022, about 17.7 million people reported daily or near-daily marijuana use, compared with 14.7 million people who reported drinking at the same frequency, said the report, which was based on more than four decades of data from the National Survey on Drug Use and Health. It was the first time the survey recorded more frequent users of cannabis than alcohol, the report added.
    • “The research was published Wednesday in the peer-reviewed journal Addiction. The research window spans the years 1979 to 2022, and the 27 surveys that were analyzed involved more than 1.6 million participants during that time frame.”
  • STAT News reports,
    • “Enticed by the immense market opened by GLP-1 weight loss drugs Wegovy and Zepbound, a handful of biotech companies are trying to develop next-generation, longer-lasting therapies based on a very different approach: RNA interference.
    • “This Nobel Prize-winning science works by degrading the biological blueprints that RNA use to make proteins — without the genetic instructions, the troublesome proteins are never made and the gene is essentially muted.
    • “If the companies succeed, it would be a significant shift in the obesity treatment revolution, away from weekly drugs targeting hormones to medications that could be given much less frequently — twice a year or even less — and pinpoint genetic contributors to weight.
    • “Scientists at Regeneron and Alnylam are aiming to silence a gene expressed in the brain called GPR75, what Regeneron Chief Scientific Officer George Yancopoulos calls the “laziness gene.” Through sequencing of almost 650,000 people, they found that those with a mutation to the gene have a lower body-mass index and lower risk of obesity.
    • “Alnylam has also homed in on the INHBE gene, expressed in the liver. Scientists found that people with mutations in the gene have a lower waist-to-hip ratio — a surrogate for abdominal fat, the type of fat that’s especially harmful and is linked to cardiovascular problems. Other companies like Wave Life Sciences and Arrowhead Pharmaceuticals have caught on and are also pursuing RNAi therapies aimed at blocking INHBE.”
  • Medscape explains the scientific impact of the recent creation of a map of the human ovary.
  • BioPharma Dive takes “An early look at cancer drug study results; Clinical trial abstracts posted Thursday ahead of this year’s ASCO meeting give a peek at anticipated datasets from Immunocore, Merck & Co., J&J and Arcus.”
  • The NIH Director writes in her blog,
    • “Human consciousness requires a person to be both awake and aware. While neuroscientists have learned a great deal from research about the underlying brain networks that sustain awareness, surprisingly little has been known about the networks that keep us awake.
    • “Now, an NIH-supported team of researchers has mapped the connectivity of a neural network they suggest is essential for wakefulness, or arousal, in the human brain. According to the researchers, this advance, reported in Science Translational Medicine , is essential for understanding human consciousness. It may also lead to new ways of understanding what happens in the brain when people lose consciousness, with potentially important implications for treating those who have entered a coma or vegetative state.
    • “The team—led by Brian Edlow , Massachusetts General Hospital and Harvard Medical School, Boston, and Hannah Kinney , Boston Children’s Hospital and Harvard Medical School—set out to map the brain network that sustains wakefulness in a manner similar to earlier research that identified the default mode network, which influences awareness. Default networks in the brain are most active when people are at rest rather than focused on a goal-oriented task.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Express Scripts — one of the largest pharmacy benefit managers in the country — has notched a major partnership with independent pharmacies, amid contentious relations between the two industries.
    • “The Cigna-owned PBM unveiled a collaboration on Thursday with pharmacy network CPESN USA to coordinate care delivery for seniors on Medicare with hypertension and diabetes, two common chronic conditions. CPESN’s independent pharmacies will also help identify at-risk patients and improve medication management, according to a release.
    • “Express Scripts and CPESN plan to expand the partnership based on client feedback, said a spokesperson for Evernorth, Cigna’s health services business and the division that includes Express Scripts. Financial terms of the partnership were not disclosed.”
  • Per Fierce Healthcare,
    • “After several years of modest or declining growth, the average pay for doctors jumped 5.9% in 2023, rebounding from a decline of 2.4% in 2022.”After several years of modest or declining growth, the average pay for doctors jumped 5.9% in 2023, rebounding from a decline of 2.4% in 2022.
    • “Most medical specialties experienced positive growth in 2023, with the top 10 seeing annual growth rates exceeding 7%, according to the 2024 Physician Compensation Report from professional medical network Doximity. 
    • “Among specialties, hematology and family medicine claimed the top two spots, with double-digit percentage growth compared to 2022 (12.4% and 10.2%, respectively).” 
  • Beckers Hospital Review lists the forty highest paid physician specialties based on this report.
  • Beckers Health IT calls attention to Newsweek’s list of “the top digital health companies in the U.S. for 2024, including a breakout of 50 data analytics companies.”
  • Beckers Hospital Review identifies “10 new drug shortages, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.”

Tuesday Tidbits

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Obesity, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • MedPage Today tells us,
    • Senators and experts on Tuesday examined the range of tools that brand-name drug manufacturers have used to keep generic and biosimilar competition at bay — from patent thickets and product hopping to “pay-for-delay” settlements — and wrestled with how to prevent such abuses.
    • “Too often the prices charged by Big Pharma do not reflect a scientific advancement,” argued Sen. Dick Durbin (D-Ill.), during a Tuesday hearing of the Senate Committee on the Judiciary. “Rather, they’re the result of skilled lawyers manipulating the patent system and skirting our nation’s competition laws.”
  • The Department of Health and Human Services announced,
    • “The Biden-Harris Administration is committed to lowering health care costs, promoting innovation, and making sure that taxpayer investments result in advancements in biomedical research that are accessible to everyone across the country.
    • “Today, the National Institutes of Health (NIH) issued a first of its kind draft policy proposal to promote equitable access to products stemming from NIH-owned inventions. By requiring organizations partnering with the NIH through patent license agreements to outline detailed plans for patient access to drugs, biologics, vaccines, or devices developed from NIH-owned inventions, we are accelerating how breakthroughs in medical research originating from the NIH’s Intramural Research Program can translate into affordable and sustainable solutions for patients across the country. NIH has released a request for information and welcomes public input to inform this new policy.”
  • The American Hospital News informs us,
    • “The Centers for Medicare & Medicaid Services May 21 announced that individuals now have the option to file an Emergency Medical Treatment and Labor Act complaint directly with the agency, in addition to the traditional process of contacting state survey agencies. The new form is the latest in a series of new resources from CMS to help educate the public about EMTALA.” 

From the public health and medical research front,

  • Beckers Hospital Review points out,
    • “The CDC is asking health officials in all 50 states to continue monitoring the prevalence of influenza as H5N1 bird flu infections among poultry and livestock increase and have begun to prompt concern over the possibility of human-to-human transmission, according to a news release shared with Becker’s.”The CDC is asking health officials in all 50 states to continue monitoring the prevalence of influenza as H5N1 bird flu infections among poultry and livestock increase and have begun to prompt concern over the possibility of human-to-human transmission, according to a news release shared with Becker’s.
    • “As of May 21, there has only been one confirmed human infection of the current H5N1 outbreak in a dairy farm employee in Texas, but no evidence of human-to-human transmission.”
  • KFF adds a report titled “Who is at Risk Amid the H5N1 Influenza Outbreak? Characteristics and Health Coverage of Animal Production Workers.”
  • The Blue Cross Blue Shield Association lets us know,
    • “Despite the explosion in demand for weight loss drugs known as GLP-1s, 58% of patients discontinue use before reaching a clinically meaningful health benefit. This is the key finding from new researchreleased by the Blue Cross Blue Shield Association (BCBSA) and conducted by Blue Health Intelligence® (BHI) based on data from nearly 170,000 commercial health plan members since the first FDA approval for a weight-loss GLP-1 in 2014.  
    • “When patients take medication, we want it to be safe and effective,” said Razia Hashmi MD, MPH, FAAFP, vice president of Clinical Affairs at BCBSA. “This study shows most people are unlikely to see lasting benefits.  Unfortunately, weight loss isn’t as simple as filling a prescription.”
    • “In the largest study using commercial data to date on this topic, BHI’s assessment also found that 30% of patients discontinued use of the medications within the first month. 
    • “This study underscores how much more we have to learn about these medications,” said Kim Keck, president and CEO of BCBSA. “The science behind these drugs is moving faster than our ability to truly understand which patients will benefit, how to sustain their success and how to pay for them. If we don’t get it right, we will drive up costs for everyone with little to show for it.” 
  • STAT News reports,
    • “Hundreds of genetic variants can nudge someone’s risk of breast cancer up or down or towards a particular subtype. The studies identifying those gene variants, though, have largely involved people with European ancestry and thus give a less accurate picture of breast cancer risk for people who are not white.
    • “That’s beginning to change. Last week, researchers published a genome-wide association study on breast cancer in roughly 40,000 people of African descent in Nature Genetics, marking a leap forward in scientists’ knowledge of breast cancer genetics in people of African ancestry.
    • “Before we started this study in 2016, there were just several thousand cases for Black Americans. It was a very small number,” said Wei Zheng, the study’s senior investigator and a cancer epidemiologist at Vanderbilt University. This study combined data from dozens of other studies and included genetic data for thousands of new participants, making it the largest combined breast cancer genetics study done with people with African ancestry.
    • “Specifically, the study compiled data from about 30 different studies investigating breast cancer in African or African American people. About 18,000 of them had breast cancer, while the other 22,000 were healthy controls, and investigators were able to scour their genetic data for specific variations that seemed closely related to breast cancer. The statistical power that comes with such numbers enabled the team to make two key advances.
    • “First, the team found 12 loci, or locations in the genome, that showed a significant association with breast cancer. Of those, the team identified variants of three genes that appear to increase the risk of triple negative breast cancer, one of the most aggressive subtypes. Since everyone has two copies or alleles of each gene, that means someone could have anywhere between one and six risk-related alleles of these three genes. Those who had all six risk-related alleles had roughly double the chance of getting triple negative breast cancer than those who only had three. * * *
    • “The other advance came when the researchers used the data to build a breast cancer risk prediction model for people with African ancestry. Such models take into account hundreds of different genetic variants that can slightly push breast cancer risk up, adding them all up into a polygenic risk score.”
  • The Wall Street Journal relates,
    • GSK’s experimental drug for asthma met its goals in the latest trial, moving a treatment with potential annual peak sales of more than 3 billion pounds ($3.81 billion) closer to market.
    • The British pharmaceutical company’s depemokimab drug reduced asthma attacks in late-stage trials for patients with severe eosinophilic asthma, a form of the disease caused by high levels of white blood cells, GSK said Tuesday.
    • Depemokimab could be the first approved drug to allow a long-term dosing interval, requiring only two injections a year. This would benefit patients exposed to multiple therapies, the company said.
    • GSK plans to submit the drug for approval for severe asthma in the U.S. in the second half of the year.
  • Per MedTech Dive,
    • “The Food and Drug Administration is seeking examples of artificial intelligence and machine learning models that can identify and predict freezing of gait events related to Parkinson’s disease. 
    • “Freezing of gait is a temporary loss of forward movement while walking. These episodes affect people’s quality of life and daily activities, but they can be difficult to measure because they often happen when patients are outside of a clinic or hospital setting. 
    • “By testing these models against its own data, the FDA hopes to better understand the ability of these technologies to provide digitally derived endpoints that could help with early disease detection and prevention or support treatment and care in the home.” 
  • From the U.S. healthcare business front,
  • Milliman tells us, “In 2024, the cost of healthcare for a hypothetical American family of four in a typical employer-sponsored health plan is $32,066, according to the Milliman Medical Index (MMI).”
  • The Wall Street Journal reports,
    • “National drugstore chains, once resistant to the retail apocalypse that swept across the U.S., are finally succumbing to competition from online shopping and discount stores.
    • “About 3,000 fewer drugstores were open for business at the start of this year compared with the same period in 2019, according to analytics company RetailStat, which tracks 15 pharmacy chains. 
    • “CVS Health, Walgreens and Rite Aid have each closed hundreds of stores since the onset of the pandemic. Online shopping has been growing and offers customers a more convenient way to buy household staples. 
    • “Competition has also increased from discount retailers such as Walmart, grocers such as Aldi, and dollar stores, which all sell many of the same items at lower prices. The spread of beauty stores such as Sephora further siphoned customers from drugstore aisles. 
    • “Everybody’s gone after a component of their business,” said Henry Fonvielle, president of the real-estate company Rappaport.”
  • STAT News notes that “Reports of telehealth’s death have been greatly exaggerated.”
    • “Virtual care isn’t in trouble. What is in trouble are the aftermarket telehealth solutions that largely function as a virtual extension of our siloed, fragmented health care system. This specific application of virtual care, which we call Telehealth 1.0, has consistently failed to bring meaningful value to patients, clinicians, and purchasers.
    • “In that sense, its collapse is a welcome development. It’s a sign that the market discerns where the real value lies in virtual care, and it validates the evolution from transactional, one-off care to more sophisticated virtual-first models.”
  • Per Healthcare Dive,
    • “UnitedHealth-owned Optum Rx, one of the biggest pharmacy benefit managers in the U.S., is launching a new drug pricing model next year meant to make payers’ spending on pharmaceuticals more predictable.
    • “The model, called Clear Trend Guarantee, combines costs that used to be separated out, including retail pharmacy, home delivery, specialty drug and rebates, into one single per-member price, according to a Monday release.
    • “Clear Trend is value-based, meaning Optum Rx will share in any savings tied to patient outcomes created in the model.”
  • Per Fierce Healthcare,
    • “The Purchaser Business Group on Health has unveiled a new purchasing agreement that aims to improve maternal health.”The Purchaser Business Group on Health has unveiled a new purchasing agreement that aims to improve maternal health.
    • “Benefits experts at retail giant Walmart and technology company Qualcomm led the initiative as co-chairs, with the goal of establishing “a collective commitment among employers and public purchasers of healthcare” to address maternal health and birth equity, according to an announcement from PBGH.
    • “The agreement centers on five key principles: deploying evidence-based, coordinated models to ensure high-quality care; ensuring timely access; promoting equitable care built on cultural humility; transparency and accountability; and value-based care.
    • “It also establishes a consensus for employers and public healthcare purchasers as to what high-quality and high-value maternity care is and outlines expectations for both insurers and providers to follow to meet that bar.”
  • Per BioPharma Dive,
    • “A decade ago, as British drugmaker AstraZeneca fought off a hostile takeover bid by Pfizer, CEO Pascal Soriot made a big promise: The company, he said, would boost sales by nearly three-quarters to reach $45 billion by 2023.”A decade ago, as British drugmaker AstraZeneca fought off a hostile takeover bid by Pfizer, CEO Pascal Soriot made a big promise: The company, he said, would boost sales by nearly three-quarters to reach $45 billion by 2023.
    • “With that goal now successfully met, Soriot on Tuesday announced a plan to push the company even higher, setting a target of $80 billion in annual sales by 2030. A slate of new medicines in metabolic and autoimmune disease headline the plan, which also involves sustaining existing businesses in respiratory disorders and cancer.
  • Beckers Hospital Review calls attention to “Fortune and PINC AI’s “15 Top Health Systems” list released May 21.”
  • McKinsey & Company discusses what’s new in consumer wellness trends.

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.”