Tuesday Tidbits

Congress

Tuesday Tidbits

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Happy Memorial Day!

David Ermer–ACA, CDC, Congress, COVID-19, Medical / Rx research, Obesity, U.S. Healthcare, Uncategorized–

From Washington, DC —

  • Congress is not in session this week of Memorial Day.
  • FEHB and for the first time PSHBP plans must submit their 2025 benefit and rate proposals no later than this coming Friday May 31.
  • The No Surprises Act RxDC reporting deadline for the 2023 calendar year is this coming Saturday, June 1.

From the public health and medical research front,

  • The Washington Post warns us,
    • “Summer offers a reminder of why covid is unlike the flu, a more predictable fall and winter respiratory virus. Coronavirus ebbs and flows throughout the year, and hospitalizations have always risen in summer months when people travel more and hot weather drives people indoors. For now, covid activity is low nationally, the CDC said Friday. The number of Americans dying of covid is less than half what it was a year ago, with a death toll around 2,000 in April. The virus poses a graver threat to the severely immunocompromised and elderly. But it can still surprise younger healthy people, for whom a bout of covid can range from negligible sniffles to rarer long-term debilitating effects. * * *
    • “The CDC and health authorities continue to promote the coronavirus vaccine, last updated in fall 2023 for a subvariant no longer in circulation, as the best form of protection against the disease. Just 23 percent of adults have received a dose of the latest vaccine, the CDC estimates. Experts say the existing formula should still confer protection against severe illness from the FLiRT variants. People 65 and older qualify for a second dose, but only 7 percent have received two shots.”
  • The Post also lets us know,
    • “When asked, 75 percent of survey respondents said they felt mental health conditions are identified and treated worse than physical health issues, according to a new survey from West Health and Gallup.
    • “The poll surveyed a random sample of 2,266 U.S. adults 18 and older. In addition to perceptions about treatment, the survey also gauged mental health conditions among participants. Of the respondents: 51 percent reported experiencing depression, anxiety or another mental health condition in the previous 12 months. * * *
    • “The main barriers, according to those surveyed, were affordability and difficulty in finding an adequate provider. Participants also cited shame and embarrassment as keeping them from treatment. This was particularly felt among participants who had experienced a mental health issue in the past year: 74 percent of those respondents thought people with mental health conditions are viewed negatively. 
    • “Additionally, 75 percent of adults 65 or older thought mental health conditions carry a negative stigma, but 53 percent of the participants felt psychological counseling or therapy is “very effective” or “effective.” Fewer adults felt medication was effective.”
  • Fortune Well tells us,
    • “Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders of childhood, and it’s usually diagnosed in kids. But ADHD tends to be underdiagnosed in women and people of color, which can lead to some people reaching adulthood before realizing they may have the condition.” 
    • The article delves into the signs and symptoms of ADHD in adults and treatment options.
  • Fortune Well also considers,
    • “Could Ozempic be the answer to a longer life?
    • “It’s the question many scientists are asking about the controversial drug, a glucagon-like peptide-1 receptor agonist (GLP-1), as some research suggests it could help humans age with less chronic diseases. The same goes for glucose-dependent insulinotropic peptide receptor agonists (GIP) such as Zepbound and Mounjaro, leaving some experts to start seeing them as potential longevity pills and considering how in the future they can be prescribed safely to more people, especially as rates of obesity continue to rise.
    • “The singular most effective and consistent way of extending lifespan in animals is caloric restriction,” says Dr. Douglas Vaughan, a professor of medicine at Northwestern University and director of the Potocsnak Longevity Institute. “That’s been demonstrated to work on everything from worms to flies to mice to monkeys. If you can find a way to get people to chronically reduce their caloric intake, it sort of makes sense that it might have an effect on aging. It’s probably not as simple as that and there could be unexpected effects of these drugs that might negate or prevent the anti aging effect, but it’s a great hypothesis and it needs to be tested rigorously.”

From the U.S. healthcare business front,

  • Fierce Healthcare notes,
    • “Elevance Health’s philanthropic arm is launching a new initiative that aims to provide loans to small businesses and other organizations in a bid to address health equity.
    • “The Elevance Health Foundation has made a $10 million commitment to the “impact investing” effort, according to an announcement. The loans offered through the program will be offered at below Prime rates, and the partners will deploy the funds to address key social needs like access to care, food insecurity and health disparities.
    • “The foundation also intends to seek out purpose-driven businesses that may not be able to access traditional banking, particularly those owned by women and people of color, who can impact equity in their communities.
    • “Shantanu Agrawal, chief health officer at Elevance Health, told Fierce Healthcare that the foundation has historically offered grant-based programs, which does limit the reach of its work to non-profit organizations. The team “took a step back” and examined other ways it could invest in communities before landing on this loan program, he said.”
  • The Wall Street Journal reports that
    • “the debt-collection spree is an example of how some hospitals in recent years have become more aggressive in recouping bills from the estimated more than 15 million Americans who have medical debt. The issue can be particularly acute in rural areas like Pratt, where residents are more likely to be older and uninsured, and hospitals are under financial stress. 
    • “A nationwide increase in debt-collection cases has drawn scrutiny from some attorneys and judges who say they eat up court and law-enforcement resources. In nine states with easy-to-access court data, debt cases—including those for medical bills, credit cards, and auto and student loans—made up 29% of civil dockets in 2013, compared with 42% in 2021; debt claims were the most common civil cases in 13 of 16 states that year, according to the nonprofit Pew Charitable Trusts.”

Friday Factoids

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, U.S. Healthcare–

Photo by Sincerely Media on Unsplash

From Washington, DC

  • The U.S. Office of Personnel Management’s proposed supplemental Postal Service Health Benefits Program (PSHBP) rule appears in todays’ Federal Register. The public comment deadline is June 24.
  • The proposed rule includes a requirement that PSHBP annuitants eligible for Medicare Parts A or B must participate in their PSHB plans’ Medicare Part D EGWP. Those who opt out will not be eligible for their PSHB plans’ regular prescription drug benefits. Here is a link to the proposed rule’s preamble where OPM lays out it thought process.
  • Healthcare Dive tells us,
    • “The House Budget Committee met Thursday to discuss the impact of healthcare mergers and acquisitions on cost, quality and access and arrived at a bipartisan consensus: Something needs to be done to halt the rampant pace of consolidation before it inflates medical costs further.
    • “What, exactly, remains unclear, though lawmakers and witnesses during the hearing expressed support for standardizing Medicare payments between hospital-owned outpatient sites and independent physician offices for the same services.
    • “Such site-neutral policies are “very bipartisan,” testified Sophia Tripoli, the senior director of health policy at patient advocacy group Families USA. “It is a no brainer.”
    • “Congress has been increasingly interested in tamping down on healthcare consolidation amid a mountain of evidence it increases costswithout a corresponding increase in care quality, harming Americans’ ability to access and afford medical care. After a merger, hospitals can jack up their prices anywhere from 3% to 65%, according to a Rand review from 2022.
    • “We just can’t afford to have this continued increase in prices,” said Rep. Ron Estes, R-Kan., during the hearing.”
  • BioPharma Dive lets us know,
    • “A top Food and Drug Administration official on Friday again advocated for the speedy approval of gene therapies for rare diseases. But he didn’t drop any clues on where the agency stands on a coming decision to possibly broaden use of one of them, a Duchenne muscular dystrophy treatment the regulator cleared last year.
    • “At a meeting hosted by the patient advocacy group CureDuchenne, Peter Marks, head of the FDA office that reviews gene therapies, said the agency’s thinking has changed in recent years to become more patient focused. That mindset has led it to more aggressively look for ways to speed the development of rare disease gene therapies.
    • “Although we’re a regulatory agency,” he said, the regulations “have to ultimately serve getting products to patients. So we’re trying to focus on the patient, and use that to negotiate the regulations to get there as rapidly as possible.”
    • “Those comments build on points Marks has made before. Last year, at a meeting held by a different advocacy group, he advocated for flexibility in reviewing rare disease gene therapies while fighting off criticism about accelerated approvals, which allow drugmakers to bring therapies to market based on interim measures of benefit. On Friday, he again threw support behind speedy clearances, noting that they are a “very important” tool in bringing forward rare disease treatments.”
  • Tammy Flanagan writes in Govexec about “What is the retirement age for federal employees?”

From the public health and medical research front,

  • The Centers for Disease Control informs us today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare remains low nationally.
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are at low levels.
    • “Nationally, COVID-19, influenza, and RSV 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.”
  • STAT News reports
    • “Stroke prevalence has been climbing over the past decade, reversing a steady decline among all Americans while rising the most among adults under 65, a new CDC analysis reports.
    • “Strokes still strike more adults older than 65, but the increase at younger ages mirrors another recent turnaround: rates of heart failure deaths, which had been dipping, are rising the most in adults under 45.
    • “The rising prevalence comes even though medicines to tamp down such risk factors as hypertension and high cholesterol, as well as technologies to treat strokes, are much more available in wealthier countries like the U.S. than elsewhere around the world.
    • “Stroke rates in the United States had fallen by 3.7% during a five-year stretch ending in 2010, but they headed back up by 7.8% through 2022. The increase was nearly double — 15% — for adults younger than 65. Thursday’s Morbidity and Mortality Weekly Report broke it down further to a jump of 14.6% among adults age 18 to 44 and 15.7% among those age 45 to 64.”
  • and
    • “Novo Nordisk’s Ozempic cut the risk of death in a trial of patients with type 2 diabetes and chronic kidney disease, suggesting it may offer some added benefits over other classes of drugs approved to treat this population.
    • “Specifically, the diabetes drug cut the risk of cardiovascular-related deaths by 29% and all-cause deaths by 20%. Given the study parameters, this implies that over three years, 39 people would need to be treated to prevent one death from any cause, according to new results presented Friday at a meeting of the European Renal Association and published in the New England Journal of Medicine.
    • “Ozempic also lowered the risk of major heart complications — including cardiovascular-related death, heart attack, or stroke — by 18%, driven primarily by the reduced rate of heart-linked death.
    • “The full results of this trial, called FLOW, affirm the primary result reported earlier this year that Ozempic reduced the risk of major kidney events — including kidney failure, reduction in kidney function, or death from kidney or heart causes — by 24%.”
  • The New York Times relates,
    • “Colorectal cancer rates are rapidly rising among adults in their 20s, 30s and 40s, and the most common warning sign for the disease is passing blood in the stool, according to a new scientific review.
    • “Rectal bleeding is associated with a fivefold increased risk of colorectal cancer, according to the new analysis, which looked at 81 studies that included nearly 25 million adults under 50 from around the world.
    • “Abdominal pain, changes in bowel habits and anemia are other common warning signs of the disease and should not be ignored, said the researchers, who published the paper on Thursday in the journal JAMA Network Open.”

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Eli Lilly plans to spend another $5.3 billion building production capacity for its popular obesity and diabetes drugs, responding to immense demand for the medicines with what it claims is now the largest investment of its kind in U.S. history.
    • “The commitment announced by Lilly Friday adds to $3.7 billion the drugmaker already planned to invest in a manufacturing site it’s constructing in Lebanon, Indiana, some 30 miles from its corporate headquarters in Indianapolis.
    • “The site will help Lilly make the active drug ingredient tirzepatide, which is in its weight loss shot Zepbound and diabetes treatment Mounjaro. Despite pressing hard to expand manufacturing capacity, Lilly has so far had trouble keeping the drugs in steady supply. Certain dose strengths of both products are currently listed as in shortage by the Food and Drug Administration, with limited availability at least through the end of June.”
  • Beckers Behavioral Health points out,
    • “UnitedHealth Group’s Optum has acquired Plymouth, Minn.-based CARE Counseling, the Star Tribune reported May 23. 
    • “CARE Counseling has 10 locations in the Minneapolis area, and employs over 200 clinicians. 
    • “Expanding and diversifying our behavioral health care delivery capabilities through this combination will build on a strong foundation of patient-centered, high-quality and affordable care in an environment that supports and enables the talented clinicians delivering these critical services,” UnitedHealth Group told the Star Tribune. “We look forward to working with CARE Counseling to build on their deep roots in the community.”
  • Reuters reports,
    • “CVS Health Corp (CVS.N), opens new tab has been seeking a private equity partner to fund growth at Oak Street Health, a primary care provider it bought a year ago, Bloomberg News reported on Thursday.
    • “The company has been working with financial advisers to help find capital to back new clinics that will be opened by Oak Street, the report said, citing people familiar with the matter.
    • “The deliberations are in a preliminary stage and the structure could change, while there is no guarantee a deal will be reached, according to the report.”

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.”

Midweek Update

David Ermer–CDC, Congress, Medical / Rx research, NIH, No Surprises Act, OPM, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington DC,

  • The House Oversight and Accountability Committee held a hearing this morning titled “Oversight of Our Nation’s Largest Employer: Reviewing the U.S. Office of Personnel Management, Pt. II”. The witness was OPM acting Director Rob Shriver.
  • Here are links to the opening statements from the Chairman James Comer (R KY) and Mr. Shriver.
  • Here are links to articles about the hearing from Govexec and Federal News Network.
  • The FEHBlog attended the hearing and he heard Mr. Shriver mention a discussion with a member of Congress about a pending OPM legislative proposal. Here is a link to OPM’s March 24 publication on its FY 2025 legislative proposals. Here is a blurb on the discussed proposal (see p. 36):
    • Beginning in FY 2026, this proposal would allow OPM to access a capped amount of mandatory funding annually from the Employees Health Benefits Fund to develop and maintain eligibility and enrollment systems for PSHB and FEHB. The cap would start at $37 million in 2026 and gradually increase, for a 10-year cost of $474 million. This proposal would provide consistent, stable funding for continued operation of the PSHB eligibility and enrollment system and potential expansion to FEHB.
  • MedPage Today lets us know,
    • “Providing nutritious meals to vulnerable populations can save lives and curb healthcare costs, experts said during a hearingopens in a new tab or window of the Senate Health, Education, Labor, and Pensions (HELP) Subcommittee on Primary Health and Retirement Security on Tuesday.”Providing nutritious meals to vulnerable populations can save lives and curb healthcare costs, experts said during a hearingopens in a new tab or window of the Senate Health, Education, Labor, and Pensions (HELP) Subcommittee on Primary Health and Retirement Security on Tuesday.
    • “Poor nutrition is the top cause of death and disability in the United States … causing more harm than tobacco use, alcohol, physical inactivity, and air pollution,” said Dariush Mozaffarian, MD, DrPH, director of the Food is Medicine Institute at Tufts University in Boston.
    • “What that means, in reality, is that the inability to access healthy food is “literally lethal,” Mozaffarian said. And while thousands of Americans know their diets are making them sick, many feel powerless to fix the problem.
    • “Witnesses argued that food is medicine, which is why produce prescriptions, medically tailored meals, and counseling programs have been shown to substantially benefit patients with diabetes, depression, pain, and other chronic issues.'”
  • Health Affairs Forefront brings us up to date on No Surprises Act developments. Of note,
    • “On April 23, 2024, the Administration released a status update on implementation of the [Advanced Explanation of Benefits] AEOB requirement. The update included a summary of a September 2022 Request for Information (RFI), through which the Administration had sought recommendations on how to exchange data between payers and providers. The Administration received feedback on patient privacy concerns, how surprise billing protections should be represented in the AEOB, exemptions for small and rural providers, and support for underserved and marginalized populations. Most comments also advocated the testing of data standards in real-world settings prior to a national rollout of standards for the data exchange. 
    • “In addition to the RFI, HHS explained that it had studied the needs and capabilities of providers, payers, and third-party vendors such as electronic health records vendors, clearinghouses, and standards development organizations. HHS investigated different kinds of providers and payers to understand existing claims processes, communications channels, and potential financial and operational constraints. Digital service researchers recommended that the Administration propose a single data exchange standard for the receipt of [Good Faith Estimates] GFEs by payers and the transmission of AEOBs from payers to patients to implement those provisions efficiently. * * *
    • “Lastly, the Administration reported that it is “exploring opportunities to promote real-world testing of the implementation guide” being developed by a cost transparency workgroup. HHS emphasized the importance of working with industry partners “to implement an efficient process for creating meaningful protections for patients from unexpected medical bills.”

From the public health and medical research front,

  • MedPage Today tells us,
    • “A Michigan farmworker has been diagnosed with bird flu — the second human case associated with an outbreak in U.S. dairy cows.
    • “The patient had mild symptoms, Michigan health officials said in announcing the case Wednesday. The person had been in contact with cows presumed to be infected, and the risk to the public remains low, officials said.
    • “In a statement, the CDC noted that an initial nasal swab turned up negative for influenza, but an eye swab sent to the agency tested positive for influenza A(H5) virus. Similar to the other U.S. case reported earlier this year [in Texas], the Michigan patient only had eye symptoms.”
  • The Hill reports,
    • “HIV infections in men decreased by an estimated 12 percent in 2022 compared to 2018, according to the latest data from the Centers for Disease Control and Prevention (CDC), with the largest notable decline observed among the youngest age group.
    • “The data published in the CDC’s HIV Surveillance Supplemental Report found there was a 12 percent decrease in HIV incidence between 2018 and 2022 among boys and men aged 13 and older. Among those between the ages of 13 and 24, the drop was 30 percent. * * *
    • “HIV+Hepatitis Policy Institute lamented that while rates of new cases are dropping, they still remain high. The organization noted this current pace keeps the U.S. from reaching its goal of ending the HIV epidemic by 2030 and called for increased investment into this endeavor.”
  • The American Hospital Association News reports,
    • “The AHA May 22 released a new infographic and blog highlighting how increasing drug prices and shortages are jeopardizing patient access to hospital care and exacerbating challenges hospitals are experiencing. The documents show that in 2023 drug companies continued to introduce new drugs at record prices while existing drug prices skyrocketed and consistently outpaced general inflation. The median annual price for new drugs was $300,000, an increase of 35% from the prior year. In addition, the documents highlight how drug shortages were the highest in a decade, and managing drug shortages adds as much as 20% to hospitals’ drug expenses. 
    • “Though the problem of high drug prices is not a new issue for hospitals and health systems, the rate at which drug prices are increasing combined with the problem of drug shortages is becoming unsustainable for the field and having a direct impact on patient outcomes,” the blog notes. “Higher drug prices and increasing drug shortages mean more costs for hospitals and health systems to bear, further stretching their limited resources and ultimately jeopardizing patients’ access to needed care.”
  • The New York Times points out “Despite Setback, Neuralink’s First Brain-Implant Patient Stays Upbeat; Elon Musk’s first human experiment with a computerized brain device developed significant flaws, but the subject, who is paralyzed, has few regrets.”
  • Here’s a link to the National Cancer Institute’s latest Cancer Information Highlights.
  • Per MedTech Dive,
    • “Boston Scientific’s modular cardiac rhythm management system met pre-specified safety and efficacy endpoints in a pivotal clinical trial, the company said Saturday at the Heart Rhythm Society annual meeting.
    • “The company designed the system, which consists of an implantable defibrillator and leadless pacemaker, for people who are at risk of sudden cardiac death from ventricular arrhythmias that existing subcutaneous implantable cardioverter-defibrillators (ICDs) are unable to treat.
    • “J.P. Morgan analysts said Boston Scientific reported “good results” and “solid” safety data, with the trial beating the performance goals for communication success and pacing thresholds.”

From the U.S. healthcare business front,

  • Per Biopharma Dive
    • “Biogen is scooping up a closely held immunology startup to bring more diversity to a pipeline best known for neurology products.
    • “Per deal terms, Biogen will pay $1.15 billion in cash up front to acquire Human Immunology Biosciences, or HI-Bio, and as much as $650 million more if the startup’s lead drug achieves certain milestones. The medicine, felzartamab, has completed Phase 2 trials for two kidney conditions, with a third study ongoing.
    • “The acquisition won’t affect Biogen’s 2024 financial guidance, the company said Wednesday. It plans to finance the purchase with cash and possibly draw on a revolving credit agreement. Biogen expects the transaction to close in the third quarter.”
  • and
    • “Pfizer, already in the midst of an aggressive effort to trim spending, on Wednesday disclosed new plans to cut at least $1.5 billion in additional costs over the next several years. 
    • “The program is meant to reduce what Pfizer spends on producing its medicines and will include “operational efficiencies, network structure changes and product portfolio enhancements,” the company said in a securities filing. 
    • “Given the complexity in manufacturing and longer lead times required to make changes, this program will be a multi-phased effort,” Pfizer added. The $1.5 billion target, which Pfizer expects to be realized by the end of 2027, is associated with the program’s first phase.”
  • Beckers Payer Issues lists seven providers being acquired by payers in 2024.
  • Fierce Healthcare informs us,
    • “Mayo Clinic is partnering with Zipline to provide drone delivery service for medications and supplies directly to patients’ homes as part of its advanced hospital-at-home program.
    • “The health system will integrate Zipline’s Platform 2 drone system into its campuses in Jacksonville, Florida, and Rochester, Minnesota. Mayo Clinic will use Zipline’s zero-emission, autonomous drones for quick deliveries, the organizations announced Wednesday.
    • “Through the drone service, if a caregiver notices a need for an acute medical intervention, Zipline can deliver medications and supplies from the hospital to a person’s home within minutes.
    • “Mayo Clinic’s Advanced Care at Home model has since seen 2,600 patients to date.”

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.

Monday Roundup

David Ermer–Congress, FDA, Generative AI, Obesity, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Healthcare Dive reports,
    • “The Senate Finance Committee is considering policies to create more stability in Medicare payments for doctors, an update cheered by physician groups that have long lobbied for reforming how the insurance program reimburses clinicians.
    • “Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, released the white paper on Friday proposing Medicare adjust payments to account for inflation, a key goal for physicians that argue government reimbursement hasn’t kept pace with rising costs.
    • “The Senate Finance Committee is also interested in exploring ways to use incentives to increase provider participation in alternative payment models, and potential changes to Medicare’s budget neutrality requirements, which require the CMS to cut payment to certain specialties to raise it for others.”
  • Fedweek tells us
    • The Senate Homeland Security and Governmental Affairs Committee has passed:
      • S-4035, to require that when FEHB enrollees seek to add a family member to their coverage based on a qualifying life event that the event has occurred and that the individual is eligible for coverage; require the OPM to consider coverage of ineligible individuals when conducting FEHB fraud risk assessments; require a comprehensive audit be conducted of family members currently enrolled; and require OPM to disenroll any ineligible individual found to be receiving FEHB coverage.
  • STAT News lets us know,
    • “Executives from the three major pharmacy benefit manager companies have been invited to testify before the House Committee on Oversight and Accountability next month, four sources familiar with the planning told STAT.
    • “Executives from Optum, CVS Caremark, and Express Scripts, owned by Cigna, were asked to testify before the panel on June 4. * * *
    • “Lawmakers are next eyeing action in December, when a number of health care programs and authorities are expiring.
    • “Ipsita Smolinski, founder and managing director of the consulting firm Capitol Street, said she believes some PBM reforms will pass in December, but not ones that are detrimental to the industry’s business model.
    • “They are largely Medicare and Medicaid, and provide minimal system savings,” she said.”
  • The U.S. Office of Personnel Management announced,
    • “Today, the U.S. Office of Personnel Management (OPM) highlights key actions taken to recruit, hire, and train AI and AI-related talent into the federal government. OPM’s efforts support the AI in Government Act of 2020 and President Biden’s landmark Executive Order on Safe, Secure, and Trustworthy AI.   
    • “Recruiting AI talent ensures the federal government can use the latest technology to tackle global challenges, improve government services, and better support the American public,” said OPM Acting Director Rob Shriver. “As a strategic partner to federal agencies, OPM has taken a number of actions that will set agencies up to compete for top talent in this critical field now and in the future.” 

From the public health and medical research front,

  • The Washington Post and Consumer Reports tell us about “Heart checkups you should have and those you can probably skip.”
  • Per MedTech Dive,
    • “Physician enthusiasm for new pulsed field ablation systems suggests the treatment will be rapidly adopted, to the benefit of device makers bringing the products to market, said analysts who attended the Heart Rhythm Society’s (HRS) annual meeting over the weekend.
    • “Talk about pulsed field ablation (PFA), a catheter-based cardiac ablation technique to treat atrial fibrillation (AFib), dominated the meeting in Boston.
    • “The amount of data and discussions on pulsed field ablation (PFA) was almost overwhelming, with late-breaking data presentations packed by physicians,” Citi Research analyst Joanne Wuensch said in a report to clients Sunday. * * *
    • “PFA is seen as a potentially safer alternative to traditional radiofrequency and cryoablation to treat AFib, the most common form of irregular heart rhythm. Shorter operating times are viewed as another advantage.
    • “Antiarrhythmic drugs are currently recommended as the first treatment for AFib but are associated with adverse events, according to the HRS. PFA differs from thermal ablation to disable cardiac cells by using electricity instead of heat or extreme cold.”
  • Medscape discusses how artificial intelligence fits into clinical practice.
  • MedPage Today informs us,
    • “The FDA approved the first interchangeable biosimilars to aflibercept (Eylea) to treat macular degeneration, according to an announcementopens in a new tab or window from the agency.
    • “As interchangeable biosimilars, aflibercept-jbvf (Yesafili) and aflibercept-yszy (Opuviz) have the same approved indications as the reference product: diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and neovascular age-related macular degeneration (AMD). Like reference aflibercept, the two biosimilars are administered via intravitreal injection.
    • “The FDA pointed out in the announcement that a biosimilar “has no clinically meaningful differences” from the reference product, which means that patients “can expect the same safety and effectiveness from the biosimilar as they would the reference product.” Interchangeability means that the biosimilar met other requirements and may be substituted for the reference product without consulting the prescriber.”

From the U.S. healthcare business front,

  • STAT News relates,
    • “Americans, especially Medicare beneficiaries, are getting more medical care these days. Demand from aging Baby Boomers is keeping people in doctor’s offices, and health care providers are continuing to build capacity post-Covid.
    • “Those trends — the same ones that tanked health insurance stocks a few weeks ago — made a strong mark on nonprofit health systems’ first quarter financial reports. STAT took a look at 20 large nonprofit health systems and found that all but four reported higher operating and net margins in the first three months of 2024 compared with the same period in 2023. Hospitals are seeing more patients and cutting down on the expensive contract labor they relied on during the Covid-19 pandemic. And they’re seeing strong investment gains on the non-operating side.”
  • The Wall Street Journal reports,
    • “Hims & Hers Health shares soared after the company said it would add injectable weight-loss drugs to its platform, granting access to the popular treatments to its telehealth patients.
    • “The company on Monday said it now offers access to GLP-1 injections in addition to its oral weight-loss treatments, giving users a broader option to choose from. It will be providing a compounded form of the injections that use the same active ingredients as the popular drugs Ozempic and Wegovy, which are facing shortages that are limiting access for some patients.
    • “The price for compounded GLP-1 injections will start at $199 a month. Its oral medication offering starts at $79 a month. Both are not available in all states.
    • “Hims & Hers said it plans to make branded GLP-1 options available to customers once consistent supply is available through the pharmacies’ wholesaler.”
  • Per Healthcare Dive,
    • “Steward offered specifics on how it intends to auction off its assets in motions filed in bankruptcy court last week, including a timeline for selling its hospitals and physician group as well as contingency plans, including possible closures, if the assets fail to lure qualified bidders.
    • “The physician-owned healthcare network, which filed for Chapter 11 bankruptcy earlier this month, operates 31 hospitals and a physician group, Stewardship Health, in Massachusetts, Arizona, Ohio, Pennsylvania, Arkansas, Louisiana, Texas and Florida. 
    • “All of its assets are up for sale — and Steward is looking to sell quickly, according to the filings.
    • “Steward says it is in advanced discussions with Optum and hopes to finalize an agreement in the near-term for the company to serve as the stalking horse bidder for its physician group, Stewardship Health — the initial bid that sets the floor price during auction.” 
  • NBC News notes,
    • “Many of the ADHD medication shortages that have plagued the U.S. for the last two years have now been resolved, the Food and Drug Administration says. Yet some doctors and patients report they are still struggling to get prescriptions filled.
    • “Dr. Royce Lee, a psychiatrist at the University of Chicago Medicine, said supply has gotten better but it’s still an issue for about a third of the patients he writes prescriptions for. This often means he still has to call around to pharmacies to see if they have the medications in stock, switch patients to different drugs, and deal with insurance companies to confirm coverage.
    • “I do see signs of the shortages easing up,” Lee said. “But there are still enough shortages that every day we’re having to put in a little bit of work for prescriptions that need to be changed or hunted down.”
    • “I think a lot of people are still not getting their treatments,” he added.”

Weekend Update

David Ermer–Congress, SCOTUS, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Washington, DC,

  • FYI, new Supreme Court decisions currently are handed down on Thursdays.

From the public health and medical research front,

  • The Washington Post reports,
    • “A personalized screening technique predicts preeclampsia more accurately than current guidelines relying on risk factors, recent research in the journal Hypertension suggests.
    • “A pregnancy complication marked by high blood pressure and signs of organ failure,” preeclampsia develops in about 1 in 25 U.S. pregnancies, according to the Centers for Disease Control and Prevention. Worldwide, it accounts for more than 70,000 maternal deaths and 500,000 fetal deaths each year.
    • “The new screening approach, which relies on blood biomarkers and ultrasound data in addition to information about maternal health, can accurately predict up to two-thirds of preterm preeclampsia cases, the study’s authors say.”
  • The Wall Street Journal tells us “Influencers Are Saying Sunscreen Causes Cancer. They Are Wrong.” That’s a big bowl of wrong.
  • STAT News alerts us that while wearables generate powerful data but it’s [often?] not useful to doctors, yet.
    • “Just because the Food and Drug Administration has given the Apple Watch and other wearable devices the OK to market the health benefits of their tracking and algorithms doesn’t mean that the data they generate are useful for either patients or their doctors, experts said Thursday at the STAT Breakthrough Summit West in San Francisco.
    • “Yesterday, I saw a patient with type 2 diabetes who has a continuous glucose monitor, and so she’s been tracking her blood sugar every five minutes,” said Ida Sim, a primary care physician and chief research informatics officer at the University of California, San Francisco. “[I] sat with her for almost an hour yesterday. I couldn’t get to her CGM data — she had it on her phone, but the report goes into a website that I didn’t have the login to, and it hadn’t been downloaded into my electronic medical record. So all this tracking data, I didn’t have it.”
    • “Not only do clinicians not have the ability to access data that their patients want to use to guide their care, but primary care doctors often don’t know how to interpret that firehose of data, said Sim. She asked some of her endocrinology research colleagues how they use that data and they explained the calculations needed to create biomarker metrics from them. That made the data largely useless to her as a doctor, and it was frustrating.
    • “I think the motto right now is, ‘We just give you the data, tell us what to do with it,’” but doctors don’t know what to do with it, said Sim. “But it does tell a good story sometimes. And I think we need to boil that data down into biomarkers that help us tell the story that fit the picture together, and I think we’re just not there yet because we just need to have different people in the room.”

From the U.S. healthcare business front,

  • Beckers Hospital Review tells us,
    • “Renton, Wash.-based Providence is back in the black after reporting a $176 million operating gain (2.3% margin) in the first quarter, a significant improvement on the $345 million operating loss (-5.1% margin) reported in the first quarter of 2023. “Renton, Wash.-based Providence is back in the black after reporting a $176 million operating gain (2.3% margin) in the first quarter, a significant improvement on the $345 million operating loss (-5.1% margin) reported in the first quarter of 2023. 
    • “The 51-hospital system saw first-quarter patient revenues increase 11% year over year to $7.8 billion while expenses rose 6.4% to $7.6 billion, according to financial documents. Salaries and benefits costs grew by 4% year over year to $3.9 billion as wage increases were offset by lower premium labor expenses. Contract labor declined by 42% year over year for the quarter. 
    • “We are navigating the headwinds facing healthcare by focusing on our strategies for recovery and renewal,” CFO Greg Hoffman said in a May 17 news release shared with Becker’s. “We expect the positive momentum to continue throughout the year and are excited for a strong 2024.”
  • Kaufmann Hall points out,
    • “With the Federal Trade Commission (FTC) issuing a final rule last month that bans noncompete agreements nationwide, the graphic below is our attempt to categorize the current status of complex state noncompete laws that affect physicians. Except in the event of a business sale, five states—California, North Dakota, Minnesota, Nebraska, and Oklahoma—ban all noncompete agreements for all employees, and at least 19 states either ban them for physicians or place varying limits on them for physicians. * * *
    • “Should the new FTC ban survive the mounting legal challenges it faces, its effect on the physician labor market may be limited, as not-for-profit organizations fall outside the FTC’s traditional enforcement jurisdiction. However, the agency has indicated a willingness to reevaluate an entity’s not-for-profit status and stated that “some portion” of tax-exempt hospitals could fall under the final rule’s purview.“

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.”