Tuesday Tidbits

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Federal News Network reports on the Postal Service Health Benefits Program supplemental rule creating a Medicare Part D EGWP mandate for Postal annuitants over 65, other than those living abroad.
  • While the FEHBlog thinks that the new, improved 2025 version of Medicare Part D is a good deal for FEHB and PSHB annuitants over age 65, even for those with the IRMAA tax or manufacturer coupons, the FEHBlog objects to the OPM mandate because it penalizes annuitants who opt out of the Plan’s Part D EGWP by barring them from the Plan’s prescription drug benefits without any premium reduction. Although FEHB plans do include penalties for failing to use hospital pre-certification, for example, those penalties top out at $500. Prescription drugs represent 24 cents out of every healthcare dollar according to AHIP. If Congress had intended that OPM impose such a hefty penalty, it would have said so in the Postal Reform Act. The law, however, is silent.
  • FedSmith offers advice on the upcoming Open Season while FedWeek explains the pros and cons about FEHB / PSHP high deductible plans with health savings accounts.
  • Per a CMS press release,
    • “The Centers for Medicare & Medicaid Services (CMS) announced today that the Medicare Shared Savings Program (Shared Savings Program) continues to save Medicare money while supporting high-quality care. The Shared Savings Program yielded more than $2.1 billion in net savings in 2023 — the largest savings in the Shared Savings Program’s history. In addition, Shared Savings Program Accountable Care Organizations (ACOs) are providing higher-quality care and supporting policies CMS has adopted to enhance primary care, expand access to accountable care to underserved communities, and prioritize quality care for common chronic conditions.
    • “In 2023, ACOs in the Shared Savings Program earned shared savings payments (also known as performance payments) totaling $3.1 billion, the highest since the program’s inception more than 10 years ago.  In addition, ACOs scored better on many quality measures than other types of physician groups and continued to demonstrate quality improvement. ACOs led by primary care clinicians had significantly higher net per capita savings than ACOs with a smaller proportion of primary care clinicians. These results continue to underscore how important primary care is to the success of the Shared Savings Program.”
  • Healthcare Dive tells us,
    • “Oracle Health will apply to become a Qualified Health Information Network under the federal government’s health data exchange framework, the technology giant said Monday. 
    • “TEFCA, or the Trusted Exchange Framework and Common Agreement, uses QHINs — which can represent dozens or hundreds of health systems, public health agencies, payers and health IT vendors — to support health information sharing, according to the HHS’ Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT.
    • “To get official designation, QHINs have to complete technology and security testing and agree to the data sharing rules before being onboarded. TEFCA went live in December with five QHINs, and two more organizations were approved early this year.”

From the public health and medical research front,

  • Fierce Pharma informs us,
    • “A small tweak in the dosing regimen of Eli Lilly’s Alzheimer’s disease drug Kisunla has reduced brain swelling of patients in a trial, the company said Tuesday.
    • “In the phase 3 study, 14% of patients who were on the altered dosing plan experienced brain swelling (ARIA-E) events at Week 24 versus 24% of those who received the standard dosing of Kisunla, which was approved by the FDA in July.
    • ‘The difference adds up to a 41% reduction in ARIA-E and could lead to a label change and help convince doctors to prescribe the anti-amyloid therapy, which is competing with another Alzheimer’s drug in its class, Eisai and Biogen’s Leqembi.”
  • Per MedTech Dive,
    • “Edwards Lifesciences’ Early TAVR trial results showed asymptomatic patients with severe aortic stenosis had better outcomes after transcatheter aortic valve replacement than under routine clinical surveillance.
    • “Analysts said the positive data could help Edwards reaccelerate growth in its TAVR business, where sales have slowed in recent quarters. The data were presented Monday at the Cardiovascular Research Foundation’s Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium and published simultaneously in The New England Journal of Medicine.
    • “The study is the first randomized, controlled trial to look at early intervention with TAVR as a strategy in patients with asymptomatic severe aortic stenosis, according to Edwards. The study was funded by Edwards.”
  • Per a company press release,
    • “Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) today announced that its double-blind, randomized, placebo-controlled global Phase 3 study, Stopping COVID-19 pRogression with early Protease InhibitOr treatment – Post Exposure Prophylaxis (SCORPIO-PEP), met its primary endpoint. Once-daily ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”) demonstrated a statistically significant reduction in the proportion of participants with symptomatic SARS-CoV-2 infection after exposure to household contacts with COVID-19 when compared to placebo. Specifically, the primary endpoint assessed COVID-19 symptoms onset through Day 10. Ensitrelvir was well tolerated by study participants and no new safety concerns were identified.
    • “Ensitrelvir is an investigational oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease. Ensitrelvir was granted Fast Track designation by the U.S. Food and Drug Administration in 2023 for the treatment of COVID-19. In Japan, ensitrelvir, known as Xocova®, received emergency regulatory approval in 2022 and full approval in March 2024 for the treatment of COVID-19. Ensitrelvir was also made available in Singapore based on the Special Access Route application in 2023. It remains an investigational drug outside of Japan and Singapore.
    • “COVID-19 remains an important public health priority, yet there are currently no oral antiviral medications approved for post-exposure prophylactic use. There is a need for convenient, preventive approaches to protect ourselves and those close to us from contracting SARS-CoV-2,” said Simon Portsmouth, MD, FRCP, Senior Vice President, Head of Clinical Development. “These data demonstrate a new potential for post exposure prophylactic use of ensitrelvir, expanding on the breadth of clinical and real-world evidence that establish its activity in those infected with SARS-CoV-2.”
  • AHRQ’s Medical Expenditures Panel Survey lets us know,
    • Among adults who reported ever having COVID-19, 13.7 percent reported ever having long COVID.
    • Women were more likely than men to report ever having long COVID (16.5% vs. 10.5%).
    • Adults aged 18-34 were less likely than all other age groups to report ever having long COVID (9.8% vs. 13.5%-17.9%).
    • Adults living in high-income households were less likely to report ever having long COVID (11.0%) than those living in middle-income households (15.6%), low-income or near poor households (17.4%), and those living in poor households (17.2%).
    • Adults living in a metropolitan statistical area reported lower rates of ever having long COVID than those living outside of a metropolitan statistical area (12.7% vs. 19.7%).
  • MedPage Today points out,
    • “Elevated body mass index (BMI) in children and young adults was associated with an increased risk of post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID, a large retrospective cohort study suggested.
    • “Those with obesity had a 25.4% increased risk of long COVID (relative risk [RR] 1.25, 95% CI 1.06-1.48) and those with severe obesity had a 42.1% increased risk (RR 1.42, 95% CI 1.25-1.61) compared with children and young adults who had healthy weight, reported Yong Chen, PhD, of the University of Pennsylvania in Philadelphia, and colleagues.
    • “Similarly, there was an increased likelihood of encountering any manifestation of potential long COVID symptoms and conditions among those with obesity (RR 1.11, 95% CI 1.06-1.15) and severe obesity (RR 1.17, 95% CI 1.14-1.21), they said in JAMA Network Openopens in a new tab or window.
    • “To our knowledge, this retrospective cohort study is the first and the largest to explore the association of BMI status with PASC among the pediatric population,” Chen and co-authors wrote. “The findings suggest that PASC may lead to poorer long-term quality of life, affecting physical health, educational achievement, and social development; this underscores the importance of early identification, prevention, and targeted interventions to mitigate these risks.”
  • The U.S. Preventive Services Task Force (USPSTF) has opened for a public comment the following recommendations:
    • Population: Pregnant or postpartum persons and women of reproductive age
    • Recommendation: The USPSTF recommends that clinicians screen for intimate partner violence (IPV) in pregnant and postpartum persons and women of reproductive age. See the “Practice Considerations” section for information on evidence-based multicomponent interventions and for information on IPV in men.
    • Grade: B
      Population: Older or vulnerable adults
      Recommendation The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for caregiver abuse and neglect in older or vulnerable adults. See the “Practice Considerations” section for additional information.
      Grade: I (inconclusive)
    • “In 2018, the USPSTF recommended that clinicians screen for IPV in women of reproductive age and provide or refer women who screen positive to ongoing support services. The USPSTF also concluded that the evidence was insufficient to assess the balance of benefits and harms of screening for abuse and neglect in all older or vulnerable adults. The current draft recommendation statement is consistent with the 2018 recommendation. To highlight that the evidence base focused on pregnant and postpartum persons, the USPSTF emphasized this population in this draft recommendation statement. For abuse of older or vulnerable adults, the term “caregiver” was added before abuse or neglect when appropriate to clarify when the focus was on screening for abuse or neglect perpetrated by a caregiver or someone they trust.”
    • The public comment deadline is November 25, 2024.
  • Healio relates that “A modified screening with additional questions about suicidal ideation was better at predicting suicide attempts among adolescents than the standard questionnaire, according to findings published in JAMA Network Open.
  • The Wall Street Journal notes,
    • “In Appalachia, in the heart of one of the earliest and deadliest waves of the opioid crisis, doctors at West Virginia University’s Rockefeller Neuroscience Institute are conducting a radical experiment. Using focused ultrasound waves, they are resetting cells inside the brain’s reward center, the nucleus accumbens. They hope the procedure can treat addictions ranging from drugs like opioids and methamphetamine to gambling and eating. 
    • “While neuroscientists have long defined addiction as a brain disease, tools to fight the U.S. drug crisis that is behind 100,000 overdose deaths a year have changed little in decades. Most treatment involves medications like methadone and buprenorphine to replace other opioids, or naltrexone to block the part of the brain that feels pleasure from alcohol or opioids. For many addictions, counseling and abstinence-based 12-step programs remain the go-to treatment. 
    • “At RNI’s 30-patient residential-treatment program, more than two-thirds of patients relapse within the first few weeks. Many illicit drugs, including meth and cannabis, don’t have any prescription medications to treat the addiction.
    • “Now, the institute’s trial using ultrasound is a peek at a future that treats the physical brain, rather than using medication or behavioral approaches to alter outcomes. “We need to inject technology into this,” said Dr. Ali Rezai, a neurosurgeon and executive chair at the institute.
    • “The RNI team is also studying a pill that monitors vital signs and releases overdose-reversal medication automatically in people who overdose. In another trial, they are monitoring the heart rates, emotions, sleep and cravings of thousands of drug users who are helping to train artificial intelligence to predict a relapse before it occurs, so that recovery coaches can intervene.”   

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Pfizer PFE punched back against activist investor Starboard Value on Tuesday, delivering positive quarterly results.
    • “The pharmaceutical company raised its revenue outlook for the year to between $61 billion to $64 billion, up from $59.5 billion to $62.5 billion previously. It also raised its guidance on adjusted annual earnings per share to a range of $2.75 to $2.95, up from $2.45 to $2.65. 
    • “The encouraging third quarter comes as Pfizer faces pressure from activist investor Starboard, which says poor investments in research and dealmaking have helped destroy billions of dollars in market capitalization. The latest earnings highlight Pfizer’s third consecutive quarter with positive results—a bright spot that could bolster the drugmaker, and Chief Executive Albert Bourla’s efforts to revamp the company. 
    • ‘Pfizer also beat Wall Street’s expectations on quarterly sales and earnings. The company reported sales totaling $17.7 billion, driven by Covid-19 products and cancer medicines, up from the $14.9 billion forecast by analysts surveyed by FactSet. The Covid-19 antiviral Paxlovid generated $2.7 billion in quarterly sales, while its Covid-19 vaccine Comirnaty sold $1.4 billion, both topping analyst forecasts.”
  • Modern Healthcare informs us,
    • “CVS Health’s MinuteClinic is becoming an in-network primary care provider for select Aetna plan members.
    • “Aetna commercial, individual and family health plan members in San Antonio, Houston, Atlanta and south Florida have the option to use MinuteClinic as an in-network primary care provider, with members in North Carolina becoming eligible in the coming weeks, said Dr. Creagh Milford, retail health president at CVS Health.
    • “CVS has been investing in staffing, technology and training at its MinuteClinic sites for months to expand primary care services in certain markets chosen based on patient density, demographics and existing services in those areas, Milford said.
    • “We’re seeing a lot of growth in the model,” Milford said. “Our ambition is to move the patient perception and the payer perception from one of an episodic, acute care model toward a longitudal, relationship-based primary care model.”
    • “CVS is in talks with other health plans to grow the MinuteClinic primary care approach, he said.”
  • STAT News tells us,
    • “More than a year has passed since Dana-Farber Cancer Institute dumped Mass General Brigham for a rival hospital chain, but the state’s biggest health care system is making a push now to say when it comes to cancer care, MGB’s still got it.
    • “Beginning in 2028, Dana-Farber will end its long and nationally acclaimed adult oncology partnership with Brigham and Women’s Hospital. Instead, it will team up with Beth Israel Deaconess Medical Center to open a new freestanding 300-bed, $1.68 billion cancer hospital in the Longwood Medical Area.
    • “Dana-Farber’s announcement of the divorce in September 2023 stunned executives at the Brigham and rocked the hyper-competitive hospital industry. But now MGB is fighting back by creating what it calls the Mass General Brigham Cancer Institute, which the health system is trumpeting in an intensive marketing campaign.
    • “The institute won’t be a freestanding hospital. But it will, for the first time, combine the expertise and resources of MGB’s two flagship hospitals, Massachusetts General Hospital and the Brigham, whose cancer operations were previously separated by a firewall because of the latter’s partnership with Dana-Farber.
    • “What really started as a disruptive event a year ago, saying that Dana-Farber will be exiting after a few years, has now become a new opportunity for us to rethink how we deliver care,” O’Neil Britton, chief integration officer for MGB, said Monday at a round-table discussion at Massachusetts General Hospital with reporters.”
  • Per Fierce Pharma,
    • “Exactly three years after an initial FDA green light for the third-line treatment of leukemia, Novartis’ Scemblix has won an accelerated approval to treat newly diagnosed patients.
    • “Tuesday, the FDA cleared Scemblix to treat patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. The first-line nod marks an important step for the Gleevec follow-up on its way toward reaching the company’s peak sales projection of $3 billion. 
    • “Only about 15% of Ph+ CML patients reach the third-line treatment setting, Victor Bulto, Novartis’ U.S. president, noted in an interview with Fierce Pharma. 
    • “The Swiss drugmaker has its work cut out in this use. While Scemblix has quickly become the standard of care in third-line Ph+ CML because of a lack of alternative treatments, the first-line market will feature a couple hurdles for the new entrant.”
  • Per BioPharma Dive,
    • “Paragon Therapeutics, a biotechnology company creator with a web of spinouts, is taking a new startup public to develop an emerging type of cancer immunotherapy.
    • “The startup, Crescent Biopharma, on Tuesday announced a reverse merger with GlycoMimetics, a struggling, publicly traded developer of oncology and inflammatory disease drugs. In support of the deal, the combined company has raised $200 million in financing from 17 major investment firms — among them Fairmount and Venrock Healthcare Capital Partners — and expects that money to keep it operating through 2027.
    • “The new company will take the Crescent name, be about 97% owned by Crescent stockholders, and be led by the startup’s interim CEO and Fairmount venture partner Jonathan Violin. Its chief goal will be to advance a group of cancer medicines led by a dual-pronged immunotherapy that simultaneously targets the proteins PD-1 and VEGF.
    • “Study results in September showed that approach could improve upon standard immunotherapy treatments, like Merck & Co.’s Keytruda. Drugs targeting PD-1 and VEGF have since drawn the interest of an array of biotech companies, of which Crescent is the latest to emerge.”
  • and
    • “GSK will pay $300 million to acquire a bispecific antibody from Shanghai-based Chimagen Biosciences that it believes has the potential to treat autoimmune diseases like lupus.
    • “The drug, which is currently in Phase 1 testing for cancer in the U.S. and China, is what’s known as a “T cell engager.” It binds to two cell surface proteins called CD19 and CD20, which GSK notes could help deplete malfunctioning B cells.
    • “In a Tuesday statement, GSK said it plans to begin a Phase 1 trial of Chimagen’s drug sometime next year, assuming the proposed licensing deal clears customary regulatory review.”

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC

  • OMB’s Office of Information and Regulatory Affairs disclosed it has completed its work on OPM’s supplemental Postal Service Health Benefits rule. That rule now should appear in the Federal Register’s public inspection list shortly. The rule by the way is not on today’s list.
  • The International Foundation of Employee Benefit Plans tells us,
    • The Internal Revenue Service (IRS) released annual inflation adjustments for more than 60 tax provisions in Revenue Procedure 2024-40. Many of these adjustments affect employee benefits.
    • For example,
      • Health flexible spending cafeteria plans. For the taxable years beginning in 2025, the dollar limitation for employee salary reductions for contributions to health flexible spending arrangements rises to $3,300, increasing from $3,200 in tax year 2024. For cafeteria plans that permit the carryover of unused amounts, the maximum carryover amount rises to $660, increasing from $640 in tax year 2024.
      • HSA/HDHP changes were announced before the call letter responses were due at the end of May 2024.
  • The Wall Street Journal adds,
    • “The brackets that determine how much Americans pay in taxes each year are moving up by their smallest amount in a few years.
    • “It will take more income to reach each higher tax bracket after the roughly 2.8% inflation adjustment for 2025, the Internal Revenue Service said Tuesday. The annual adjustments are based on formulas tied to inflation.
    • “This year’s adjustments slightly outpace the current inflation rate, which has been cooling. Still, average hourly earnings rose 4% from a year earlier in September, the Labor Department said.”
  • Per an HHS press release,
    • “Today, the Department of Health and Human Services (HHS), through the Office of Assistant Secretary for Planning and Evaluation (ASPE), released new data showing that nearly 1.5 million people with Medicare Part D saved nearly $1 billion in out-of-pocket prescription drugs costs in the first half of 2024 because of the Biden-Harris Administration’s Inflation Reduction Act. Thanks to the Inflation Reduction Act, some people with high drug costs have their out-of-pocket drug costs capped at around $3,500 in 2024. Next year that cap lowers to $2,000 for everyone with Medicare Part D. The report shows that if the $2,000 cap had been in effect this year, 4.6 million enrollees would have hit the cap by June 30 and would not have to pay any more out-of-pocket costs for the rest of the year.”
    • “To view the full ASPE issue brief, “Medicare Part D Enrollees Reaching the Out-of-Pocket Limit by June 2024” visit: https://aspe.hhs.gov/reports/medicare-part-d-oop-cap
  • KFF offers a data note.
    • “Overall, just under half of individuals with job-based health coverage are enrolled as a dependent on a family member’s plan (47%). The likelihood of enrolling as a dependent decreases with age. Nearly all children (ages 0-17) with employer-sponsored coverage are enrolled as dependents, usually on a parent’s plan. Young adults, particularly those ages 18-25, are more likely to be covered as dependents than adults overall (72% vs. 32%).
    • “The Affordable Care Act (ACA) requires most employer plans allow young adults to remain on a parent’s plan until age 26. Before the ACA, employers typically limited dependent eligibility for young adults to an age less than 26 and often imposed additional eligibility requirements. This provision of the ACA maintains considerable popularity and has been credited with reducing the uninsured rate among young adults. In 2024, 56% or 19.3 million young adults aged 18-25 were covered on an employer-sponsored plan (Figure 1).
    • “As young adults age, a greater share of those with employer coverage transitions from dependent coverage to being policyholders. For instance, while a majority of 18 and 19-year-olds with employer-sponsored coverage are still covered as dependents, the proportion decreases among those aged 24 and 25 (93% vs. 50%) (Figure 2).”
  • Seeking Alpha lets us know,
    • “Sen. Dick Durbin (D-Ill.), chairman of the Senate Judiciary Committee, has sent letters to Pfizer and Eli Lilly regarding the two drug giants’ relationships with telehealth platforms.
    • “Durbin is seeking to find out whether the two pharmaceutical companies are violating federal anti-kickback laws, according to the letters.
    • “Both Pfizer and Lilly this year launched websites for consumers to find out about their medications, as well as links to talk to a physician online that can prescribe them and an online pharmacy to get prescriptions filled. Pfizer’s is called PfizerForAll, while Lilly’s is name LillyDirect.
    • “Durbin, along with Sens. Bernie Sanders (I-Vt.), Elizabeth Warren (D-Mass.), and Peter Welch (D-Vt.), argue that these setups are designed to push consumers to particular drugs “and create the potential for inappropriate prescribing that can increase spending for federal health programs.”
    • “Regarding Pfizer’s platform, the senators say the ease of getting meds prescribed “creates the impression that any patient interested in a particular medication can indeed receive it with just a few clicks, and the appearance of Pfizer’s approval that these chosen telehealth providers can ensure a patient receives the given medication.”
  • It strikes the FEHBlog as strange that these legislators are attacking the drug manufacturers for disintermediating the middlemen.
  • Fierce Pharma reports
    • “With Johnson & Johnson sweetening the pot and mustering up the support of 83% of those who claim that the company’s talc products caused their cancer, it had appeared that the sides were speeding toward a resolution of the litigation through J&J’s third bankruptcy attempt.
    • “But the U.S. Department of Justice (DOJ) has called a foul.
    • “In federal bankruptcy court in Houston, Texas, the U.S. Trustee program—the DoJ’s unit that oversees bankruptcy cases—has filed a motion (PDF) to dismiss a Johnson & Johnson subsidiary’s Chapter 11 bid to settle the 60,000-plus talc lawsuits.”
  • MedTech Dive lets us know,
    • “The Food and Drug Administration on Tuesday named Michelle Tarver as the permanent director of the agency’s device center, first reported by Stat and confirmed by MedTech Dive.
    • “Tarver was appointed as acting director of the Center for Devices and Radiological Health in July, when longtime leader Jeff Shuren stepped down. 
    • “FDA Commissioner Robert Califf emphasized Tarver’s “passion about data, science, medicine, and the evidence” and work to build collaboration and transparency at the agency, in an email to staff announcing the new director’s appointment viewed by MedTech Dive.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “Four workers at a commercial egg farm in Washington tested presumptively positive for H5N1 bird flu, the Washington State Department of Health announced Oct. 20. These are the first presumed human cases in the state. The individuals experienced mild symptoms and Benton-Franklin Health District officials have forwarded test samples to the Centers for Disease Control and Prevention for final confirmation and analysis. Washington is the sixth state with human H5N1 infection, which has caused outbreaks in poultry, dairy cattle and wildlife. The CDC considers the risk of H5N1 bird flu to the general public to be low.”
  • The New York Times tells us,
    • “New guidelines for preventing strokes spell out for the first time the risks faced by women, noting that pre-term births and conditions like endometriosis and early menopause can raise the risk.
    • “Prior guidelines tended to be sex-agnostic,” said Dr. Brian Snelling, director of the stroke program at Baptist Health South Florida’s Marcus Neuroscience Institute, who was not involved in writing the guidelines.
    • “Now we have more data about sex-specific subgroups, so you’re able to more appropriately screen those patients.”
    • “The focus of the recommendations by the American Stroke Association, published on Monday in the journal Stroke, is primary prevention — the effort to prevent strokes in individuals who have never had one. It represents the first such update in a decade, and it’s the playbook by which millions of Americans will be cared for.”
  • BioPharma Dive reports about “RNA editing: emerging from CRISPR’s shadow. Early study data from Wave Life Sciences suggests how editing RNA may yield viable medicines. Large and small drugmakers say such results are just the start.”
    • “RNA editing is a fast growing corner of the biotechnology sector. About a dozen companies, from privately held startups to established biotech firms, are pursuing the technology. One already has early, but promising, clinical trial results. Others could follow soon. And large pharmaceutical companies, such as Eli LillyRoche and Novo Nordisk, have taken an interest.
    • “RNA editing’s proponents say it may be safer and more flexible than DNA editing. Those advantages, they contend, will enable RNA editing to address more diseases, including common conditions that are now beyond genetic medicine’s reach.
    • “It has all the features of a technology that could leapfrog other editing technologies,” said Michael Ehlers, a general partner at Apple Tree Partners and the CEO of RNA editing startup Ascidian Therapeutics.”
  • The U.S. Preventive Services Task Force has opened for public comment its Grade B recommendation that doctors “provide or refer pregnant and postpartum persons to interventions that support breastfeeding.” This is a confirmation of a 2016 Grade B recommendation. The public comment period is open until November 18, 2024.
  • Per Food Navigator
  • The Centers for Disease Control and Prevention issued the following alert today.
    • CDC, FDA, USDA FSIS, and public health officials in multiple states are investigating an outbreak of E. coli O157:H7 infections. Most people in this outbreak are reporting eating the Quarter Pounder hamburger at McDonald’s before becoming sick. It is not yet known which specific food ingredient is contaminated.
    • McDonald’s is collaborating with investigation partners to determine what food ingredient in Quarter Pounders is making people sick [mostly in Colorado and Nebraska]. McDonald’s stopped using fresh slivered onions and quarter pound beef patties in several states while the investigation is ongoing to identify the ingredient causing illness.
  • The Washington Post reports,
    • TreeHouse Foods has expanded an earlier recall of frozen waffles to include all its griddle products, including Belgian waffles and pancakes, over possible listeria contamination.
    • Though no illnesses have been reported, TreeHouse Foods has previously said that the breakfast products were widely distributed throughout the United States and Canada, primarily as private-label offerings by Walmart, Target, Tops, Harris Teeter, Publix and other large merchants.
    • The suspected contamination was discovered through routine testing at a manufacturing facility in Ontario, according to the company announcement.
    • “We are working with our retail customers to retrieve and destroy the recalled products, and encourage consumers to check their freezers for any of the products subject to the recall and dispose of them, or return them to the place of purchase for a refund,” the company said in an unsigned email.

From the U.S. healthcare business front,

  • OptumRx discusses its efforts to “automate prior authorization process for prescription drugs to improve the patient and provider experience.”
  • MedTech Dive brings us up to date on what happened at the MedTech Conference held last week in Canada.

Thursday Miscellany

From Washington, DC,

  • Per an HHS press release,
    • “Today, leaders from the U.S. Department of Health and Human Services (HHS), the Office of National Drug Control Policy (ONDCP), and the Substance Abuse and Mental Health Services Administration (SAMHSA) joined recovery advocates to kick off observance of the 35th National Recovery Month at the second annual SAMHSA Walk for Recovery. The National Walk for Recovery supports and celebrates recovery from substance use and/or mental health conditions while reducing stigma.
    • “In addition to hosting the walk, SAMHSA published the Gallery of Hope which features over 250 visual art entries submitted to the Art of Recovery project. The gallery highlights the transformative impact of art on mental health and substance use recovery. * * *
    • “Recovery Month, observed every September since 1989, promotes evidence-based substance use disorder and mental health treatment and recovery support practices and serves as an opportunity to celebrate the achievements of tens of millions of people in recovery and reduce stigma surrounding substance use and mental health issues. Over 65 million people consider themselves in recovery from substance use and/or mental health issues according to the 2023 National Survey on Drug Use and Health (NSDUH), among adults 18 or older in America. SAMHSA’s National Recovery Month Toolkit is available online and features recovery resources, social media assets, and weekly themes and messaging.”
  • American Hospital Association News lets us know,
    • “The Centers for Medicare & Medicaid Services Sept. 5 published a list of participants for the Transforming Episode Accountability Model. TEAM is a mandatory payment model that will bundle payment to acute care hospitals for five types of surgical episodes. The AHA June 10 urged CMS to make the model voluntary, however the mandatory model was finalized in the CY 2025 Inpatient Prospective Payment System Final Rule.”
  • Per Fierce Pharma,
    • “A year after missing on a trial endpoint, Travere Therapeutics can breathe a sigh a relief. The FDA has converted Filspari’s conditional nod in the kidney disease IgA nephropathy (IgAN) into a full approval.
    • “As part of the conversion Thursday, the FDA has removed a specific urine protein level requirement from Filspari’s label. Now, the only condition for treatment with Filspari is that patients be at risk of disease progression.
    • The adjustment will allow Filspari to reach more patients who’re at lower risk of progression, Travere CEO Eric Dube, Ph.D., said in a recent interview. The company will be able to promote Filspari’s ability to preserve kidney function, and the full approval could give more doctors confidence to start using the drug, he added.
    • During a drug launch, “those later adopters oftentimes look for things like guidelines, support or advocacy from their peers, or in this case, also full approval,” Dube said. “So we do expect that there’s going to be a broader set of nephrologists prescribing.”
  • Federal News Network informs us,
    • “The Postal Service is bringing back a holiday surcharge for some of its package services, as the agency prepares for its busy year-end peak season.
    • “The new prices will take effect on Oct. 6, 2024, and will last through Jan. 19, 2025. USPS announced the return of the holiday surcharge in a press release Thursday.
    • “USPS waived the surcharge last year, in the hopes that that lower prices would help the agency capture a bigger share of the lucrative holiday package business from private-sector competitors like UPS, FedEx and Amazon.
    • “USPS said in a press release Thursday that the temporary price adjustment will “help cover extra handling costs to ensure a successful peak season.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “The California Department of Food and Agriculture Aug. 30 reported cows in three dairy herds tested positive for bird flu. No human cases were confirmed in association with this incident. Both the California Department of Health and the Centers for Disease Control and Prevention consider the risk of bird flu to the general public as low. As of yesterday, there have been 13 total positive cases of H5 bird flu in humans, according to the CDC.” 
  • The New York Times reports,
    • “The number of teenagers who reported using e-cigarettes in 2024 has tumbled from a worrisome peak reached five years ago, raising hopes among public health officials for a sustained reversal in vaping trends among adolescents.
    • “In an annual survey conducted from January through May in schools across the nation, fewer than 8 percent of high school students reported using e-cigarettes in the past month, the lowest level in a decade.
    • “That’s far lower than the apex, in 2019, when more than 27 percent of high school students who took the survey reported that they vaped — and an estimated 500,000 fewer adolescents than last year.
    • “The data is from the National Youth Tobacco Survey, a questionnaire filled out by thousands of middle and high school students that is administered each year by the Food and Drug Administration and the Centers for Disease Control and Prevention.”
  • The Washington Post points out,
    • “A new study adds to a growing body of evidence that Parkinson’s disease, long believed to have its origins in the brain, may begin in the gut.
    • “Gastrointestinal problems are common in patients with neurodegenerative disorders, to the point where a condition known as “institutional colon” was once thought to afflict those who lived in mental health institutions. In Parkinson’s disease, the entire gastrointestinal tract is affected, causing complications such as constipation, drooling, trouble swallowing and delayed emptying of the stomach. These symptoms often appear up to two decades before motor symptoms such as rigidity or tremor.
    • “People have, for the longest time, described Parkinson’s disease as a top-down disease — so, it starts in the brain and then percolates down to the gut, and that’s why patients have issues with their gastrointestinal tract,” said study author Subhash Kulkarni, an assistant professor at Beth Israel Deaconess Medical Center. “Another hypothesis suggests that, in many patients, it may be a bottom-up approach, where it starts in the gut and goes all the way up to the brain.”
    • “Kulkarni and his colleagues found that people with upper gastrointestinal conditions — in particular, ulcers or other types of damage to the lining of the esophagus, stomach, or upper part of the small intestine — were far more likely to develop Parkinson’s disease later in life. The study was published online Thursday in JAMA Network Open.”
  • The NIH Director writes in her blog,
    • “Each year in the U.S. there are about 18,000 new spinal cord injuries, which damage the bundle of nerves and nerve fibers that send signals from the brain to other parts of the body and can affect feeling, movement, strength, and function below the injured site. A severe spinal cord injury can lead to immediate and permanent paralysis, as our spinal cords lack the capacity to regenerate the damaged tissues and heal.
    • “So far, even the most groundbreaking regenerative therapies have yielded only modest improvements after spinal cord injuries. Now, an NIH-supported study reported in Nature Communications offers some new clues that may one day lead to ways to encourage healing of spinal cord injuries in people. The researchers uncovered these clues through detailed single-cell analysis in what might seem an unlikely place: the zebrafish spinal cord.
    • “Why zebrafish? Unlike mammals, zebrafish have a natural ability to spontaneously heal and recover after spinal cord injuries, even when the injuries are severe. Remarkably, after a complete spinal cord injury, a zebrafish can reverse the paralysis and start swimming again within six to eight weeks. Earlier studies in zebrafish after spinal cord injury found that this regenerative response involves many types of cells, including immune cells, progenitor cells, neurons, and supportive glial cells, all of which work together to successfully repair damage. * * *
    • “In future work, the researchers plan to conduct similar studies in the many other cell types known to play some role in spinal cord healing in zebrafish, including supportive glia and immune cells. They’re also continuing to explore how the activities they see in the zebrafish spinal cord compare to what happens in mice and humans. With much more study, these kinds of findings in zebrafish may lead to promising new ideas and even treatments that encourage neural protection, flexibility, and recovery in the human nervous system after spinal cord injuries.”
  • The “Institute for Clinical and Economic Review publishes Evidence Report on treatments for Transthyretin Amyloid Cardiomyopathy — Current evidence suggests that tafamidis and acoramidis provide a net health benefit when compared to no disease-specific therapy; these treatments would achieve common thresholds for cost-effectiveness if priced between $13,600 to $39,000 per year.” * * * “This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC on September 20, 2024.”
  • The U.S. Preventive Services Task Force posted a final research plan for “Early Allergen Introduction to Prevent Food Allergies in Infants: Counseling.
  • Per Reuters,
    • “There is no link between mobile phone use and an increased risk of brain cancer, according to a new World Health Organization-commissioned review of available published evidence worldwide.
    • “Despite the huge rise in the use of wireless technology, there has not been a corresponding increase in the incidence of brain cancers, the review, published on Tuesday, found. That applies even to people who make long phone calls or those who have used mobile phones for more than a decade.”
  • FEHBlog comment: Whew!
  • Per MedPage Today,
    • “Having a medical condition was associated with an increased risk of suicide in a dose-response-like manner, such that the higher the burden of disability, the higher the risk of suicide, according to an observational study in Denmark.
    • “An analysis of more than 6.6 million people found that nine medical condition categories including 31 specific conditions were associated with a statistically significant increased risk of suicide, with the exception of endocrine disorders, reported Søren Dinesen Østergaard, MD, PhD, of Aarhus University Hospital, and co-authors.
    • “The associations were most pronounced for gastrointestinal conditions (incidence rate ratio [IRR] 1.7, 95% CI 1.5-1.8), cancers (IRR 1.5, 95% CI 1.4-1.6), and hematological conditions (IRR 1.5, 95% CI 1.3-1.6), they wrote in JAMA Psychiatry.
    • “The risk was highest in the first 6 months following diagnosis and subsequently faded over time, although the risk after certain medical conditions remained elevated up to 15 years after onset.”

From the U.S. healthcare business front,

  • Beckers Payer Issues provides context to Modern Healthcare’s story in yesterday’s post about HCSC offering a no deductible plan design. It’s a trend.
  • Modern Healthcare adds today,
    • “Cigna Group CEO David Cordani underscored the booming state of the company’s health services business and outlined the unit’s potential growth opportunities during Morgan Stanley’s annual Global Healthcare Conference on Thursday.
    • “Cordani said the company sees opportunities to capitalize on the $400 billion specialty pharmacy market and to drive more business for its pharmacy benefit manager, Express Scripts.
    • “Cigna has been charting strong growth this year for its Evernorth Health Services business as it pulls out of the lucrative Medicare Advantage market, and it’s already seeing positive returns. Evernorth, which houses Cigna’s specialty pharmacy and pharmacy benefits businesses, generated more than 80% of its total revenue in the second quarter ended June 30.
    • “Cordani highlighted Evernorth’s successes as the segment announced another low-cost biosimilar product. Early next year, eligible members will have access to a biosimilar for Johnson & Johnson’s Stelara arthritis drug with no out-of-pocket cost at its specialty pharmacy. Cordani said the new offering could save each member $4,000 annually.”
  • Per Fierce Healthcare,
    • “Over the past several years, Humana has made significant strides in growing its senior-focused primary care business, and a new study highlights areas where it’s seeing success in this model.
    • The study, conducted by the Humana Healthcare Research team along with Harvard researcher J. Michael McWilliams, M.D., Ph.D., digs into data from six senior-focused primary care organizations on more than 421,000 patients who were enrolled in Medicare Advantage coverage in 2021.
    • “It found that patients in these organizations had 17% more primary care visits across the board. This included 39% more visits among Black patients and 21% more among low-income patients, which can address disparities faced by these populations.
    • “The study also suggests that patients who are engaged with a senior-focused primary care model see better outcomes on multiple quality measures including cancer screenings, medication adherence and controlled blood pressure. The researchers did note that future analysis is necessary to refine these findings.”
  • Modern Healthcare notes,
    • “Ochsner Health is expanding its digital medicine program to offer weight management, the health system said Wednesday.
    • “Some [program] patients will have access to popular weight loss medications including glucagon-like peptide agonists, Ochsner said in a release. The digital medicine program has previously focused on patients with hypertension, Type 2 diabetes and hyperlipidemia.” * * * 
    • “Ochsner is the latest organization seeking to leverage the popularity of GLP-1 medications such as Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. GLP-1s have led many organizations to offer virtual weight management services, including Mayo Clinic. The Rochester, Minnesota-based organization said in January it’s testing a telehealth weight loss offering through its diet program.”  
  • Per Healthcare Dive,
    • “Henry Ford Health and Ascension will launch their joint venture in Michigan at the start of October, moving eight Ascension and Genesys hospitals and an addiction treatment center under the Henry Ford brand, the companies said on Wednesday.
    • “Detroit-based Henry Ford will double in size once the joint venture launches, growing its acute care footprint from five to 14 hospitals.
    • “The no-cash deal, announced nearly a year ago, is expected to create an organization with more than $10.5 billion in annual operating revenue. Henry Ford CEO Bob Riney will serve as the CEO of the new entity.”
  • and
    • “Female physicians and doctors who work in nonrural practices deliver more care via telehealth, according to a study published this week in Health Affairs. 
    • “The research also found differences in virtual care utilization by specialty. For example, 23% of psychiatrists delivered all or nearly all of their visits through telehealth, compared with fewer than 1% for physicians in all other specialties. 
    • “The findings offer insight into long-term patterns of telehealth utilization in the U.S. and help show how virtual care might be affecting care access and outcomes, the study authors wrote.”
  • Per Kauffman Hall,
    • Hospital financial performance remains strong this year, with continued stabilization in the month of July. Outpatient revenue and average lengths of stay showed signs of improvement.
    • The median Kaufman Hall Calendar Year-To-Date Operating Margin Index reflecting actual margins for July was 4.1%.
    • The recent [/July] issue of the National Hospital Flash Report covers these and other key performance metrics.
  • Per MedTech Dive,
    • “Abbott is working to integrate its newest continuous glucose monitor (CGM) with Beta Bionics’ automated insulin delivery (AID) system.
    • “The companies plan to connect Beta Bionics’ iLet Bionic Pancreas to Abbott’s Freestyle Libre 3 Plus CGM, according to the Wednesday announcement. Readings from the CGM will help iLet calculate insulin doses for automated delivery.
    • “Beta Bionics said the integration, which is scheduled to launch in the fourth quarter, will be the first of its kind for Freestyle Libre 3 Plus in the U.S. Abbott also has AID partnerships with Insulet and Medtronic.”

Friday Factoids

From Washington, DC

  • Fedweek posted an August update on implementation of the Postal Service Health Benefits Program (“PSHBP”).
    • “At least one major insurance carrier, FEP Blue Cross Blue Shield, has already sent letters to current participants letting them know that a plan similar to their current plan has been conditionally approved and stating that they’ll share more details on the PSHB benefits and premiums “later this year, in time for Open Season”
    • “The USPS reports new plan details will be available as of September 15, and will be sent out via hard mail in the weeks that follow.
    • “The USPS says that participants will receive a “crosswalk letter” in late October showing the new plan into which the USPS intends to enroll them. If you agree, there’s nothing to do: you’ll be enrolled in that plan.”
  • The FEHB enrollees who may be in for a surprise are those who currently participate in an FEHB plan that is not participating in the PSHBP. In October, OPM will enroll those folks in the lowest cost nationwide plan option that is not a high deductible plan or charge associate member dues. Those folks will have an opportunity to change plans during the regular federal benefits open season. The FEHBlog expects that the PSHBP navigators will be lending a helping hand to those folks, particularly those eligible for Medicare.
  • The Postal Times reminds us,
    • “If you were an annuitant entitled to Medicare Part A (typically at age 65) as of Jan. 1, 2024, and did not enroll in Medicare Part B, you and your covered eligible family members may be able to participate in a one-time PSHB Special Enrollment Period (SEP) for Medicare Part B from April 1 through Sept. 30, 2024. Those who choose to enroll during the SEP will have the late enrollment penalty paid for by the Postal Service. Eligibility letters were sent to annuitants and eligible family members in March 2024. If you have misplaced the notification letter mailed to you or believe that you are eligible to participate in the PSHB SEP and did not receive a notification letter, call the PSHB Navigator toll-free help line at 833-712-PSHB (7742) or email retirementbenefits@usps.gov.”
  • Speaking of the Postal Service, Federal News Network lets us know,
    • “The Postal Service is planning to roll out several changes next year to drive down its operating costs and ensure more reliable service to most of its customers.
    • “USPS says the next step of its network modernization plan, which will happen next year, is to get mail and packages to their destination in fewer trips between mail processing plants and post offices.
    • “The agency expects these adjustments will not only help it squeeze $3 billion of annual overhead costs out of its operations, but enable faster delivery of mail and packages to customers within 50 miles of the agency’s largest regional mail processing plants.
    • “For customers outside that 50-mile radius, however, USPS, anticipates ”some mail and packages will experience a longer service standard,”  according to a filing submitted to its regulator on Thursday. 
    • “In those cases, mail and packages in those more rural areas will remain in transit for about a day longer before reaching their final destination.
    • “USPS, however, told the Postal Regulatory Commission that these changes will have a “net positive impact” on service for first-class mail, packages and marketing mail, and will be delivered “at the same level of service or faster,” for most customers.”
  • The American Hospital News expresses distress because
    • Johnson & Johnson announced Aug. 23 that it would be fundamentally changing the way it makes 340B pricing available for two of its most popular products, Stelara and Xarelto. Starting Oct. 15, J&J will require all disproportionate share hospitals participating in the 340B Drug Pricing Program to purchase these drugs at full price and submit data to J&J. Upon verification of the drug’s 340B status, DSHs would receive a rebate for the discounted 340B price.
    • Last week, the AHA contacted the Health Resources and Services Administration for more information as soon as it was made aware that J&J was considering these actions. HRSA notified the AHA today that it has informed J&J that its rebate model is inconsistent with the 340B statute and that this model has not been approved by the Secretary of the Department of Health and Human Services. HRSA further informed the AHA that it has told J&J that HRSA will take appropriate action as warranted.

From the public health and medical research front,

  • The Centers for Disease Control and Prevention (“CDC”) announced today,
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in many areas. * * * “Nationally, the wastewater viral activity level for COVID-19 is currently very high.
    • “COVID-19
      • Many areas of the country are continuing to experience increases in COVID-19 activity, though other areas are experiencing declines in COVID-19 activity following increases this summer. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+ and children under 2 years. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • RSV
      • “Nationally, RSV activity remains low.
    • Vaccination
  • The University of Minnesota’s CIDRAP adds,
    • “High-dose (HD) and adjuvanted influenza vaccines offered the best protection for people aged 65 years and older against symptoms and hospitalization during the 2022-23 flu season, concludes a real-world study published this week in Clinical Infectious Diseases.
    • “High-dose flu vaccines contain four times the standard dose (SD), while adjuvanted vaccines contain an extra immune-boosting ingredient. In 2022, the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommended high-dose, adjuvanted, or recombinant (cell-based) vaccines over SD vaccines for older adults, who are at elevated risk for severe disease and flu-related hospitalization and death.”
  • The New York Times reports,
    • “After a years long lull thanks to Covid-19 precautions like isolation and distancing, whooping cough cases are now climbing back to levels seen before the pandemic, according to data from the Centers for Disease Control and Prevention.
    • “So far this year, there have been 10,865 cases of whooping cough, or pertussis, nationwide. That’s more than triple the number of cases documented by this time last year, and is also higher than what was seen at this time in 2019. Doctors say these estimates are most likely an undercount, as many people may not realize they have whooping cough and therefore are never tested.
    • “The pandemic delayed routine childhood vaccinations, including those that protect against whooping cough, and led to fewer pregnant women getting vaccinated. Those factors have likely contributed to the current uptick in cases, said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University Medical Center. Pertussis cases tend to peak in the summer and fall, he said, and so it’s particularly critical to be aware of the disease now, as children head back to school and respiratory illnesses pick up.”
  • Bloomberg tells us,
    • “US teenagers aren’t getting vaccinated against HPV at the same pace as before the Covid pandemic, a trend that could imperil efforts to control a common cause of cervical and other cancers.
    • “Immunization rates have stagnated for kids aged 13 to 17 for the past two years, according to data that the Centers for Disease Control and Prevention published Thursday. Meanwhile, routine shots for diseases like tetanus and meningitis have returned to pre-pandemic levels, according to the CDC survey, which analyzed results from nearly 17,000 teenagers.
    • “The trend could cause alarm among public health officials. Each year, human papillomavirus causes more than 21,000 cases of cancer in women and about 16,000 in men. * * *
    • “This is the only vaccine I know of that prevents cancer,” said Sunil Sood, a pediatrician who specializes in infectious disease at Northwell Health in New York. “Putting it like that has been known to make a difference” to parents who might be resistant to having their children vaccinated, he said.”
  • Per MedCity News, “Side Effects are Limiting GLP-1 Drug Efficacy: How Can Personalization Offer a Solution? By integrating digitization and machine learning, there is an opportunity to deliver personalized care to all patients and scale precision dosing with minimal physician involvement, maximizing the effectiveness and accessibility of these drugs.”
    • “There is a clear and unique opportunity to apply dose optimization to GLP-1s to improve real-world persistence and adherence, supporting patients to continue treatment long enough to experience the full benefits, such as positive cardiovascular outcomes. We know clinicians are seeing the need for this and are already making necessary interventions but struggling still to find a scalable solution. Pairing drugs with proven digital solutions, within a single label, can facilitate personalization across the GLP-1 market, improving the effectiveness of these drugs and diminishing side effects. Not only can pharma leverage this approach to deliver best-in-class clinical and commercial outcomes, but it also promises to revolutionize disease management, enhancing patient safety and outcomes by tailoring treatment to individual needs, truly bringing precision care to all.”
  • Pulmonary Advisor notes, “About two-thirds of adults who smoked wanted to quit in 2022, although fewer than 10% were successful, according to study findings published in the Morbidity and Mortality Weekly Report.

From the U.S. healthcare business front,

  • EBRI offers an Issues Brief concerning “Trends in Self Insured Health Coverage; ERISA at 50.”
  • Per MedTech Dive,
    • “Stryker said Thursday it has agreed to acquire Vertos Medical, an Aliso Viejo, California-based company whose minimally invasive technology treats chronic lower back pain, for an undisclosed sum.
    • “The Vertos procedure, which can be performed in an outpatient setting, is designed to provide pain relief for patients with lumbar spinal stenosis by restoring space in the spinal canal and reducing nerve compression.
    • “This acquisition strengthens our minimally invasive pain management portfolio with differentiated treatments and expands our reach across ambulatory surgery centers,” Andy Pierce, head of Stryker’s medical and surgical equipment and neurotechnology business, said in a statement.”

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC

  • Bloomberg reports,
    • “A federal judge ruled the US Federal Trade Commission can’t enforce its near-total ban on noncompete agreements that was set to go into effect next month, blocking an effort by the agency to make labor markets more competitive. 
    • “In a ruling Tuesday, US District Judge Ada Brown in Dallas sided with the US Chamber of Commerce and a Texas-based tax firm that sued to block the measure. The judge said the FTC lacked the authority to enact the ban, which she said was “unreasonably overbroad without a reasonable explanation.” 
    • “The ruling represents a significant blow for the FTC and further divides the judiciary over the regulator’s powers. A federal judge in Pennsylvania had previously sided with the FTC. The rule is likely to be headed for appellate review. Brown had previously delayed implementation of the ban, which was scheduled to take effect on Sept. 4.” 
  • The American Hospital Association News lets us know,
    • “The Centers for Medicaid and Medicare Services Aug. 20 released a report presenting data on complaints and enforcement efforts by the agency concerning title XXVII of the Public Health Service Act, which includes both the surprise billing and price transparency provisions of the No Surprises Act. As of June 30, 2024, CMS received more than 16,000 complaints and closed 12,700 with 400 complaints with PHS violations. In total the agency reported over $4 million in restitution for closed cases. Top complaints against plan issuers include non-compliance with Quality Payment Amount requirements, late payment after independent resolution determination, and non-compliance with 30-day initial payment or notice of denial payment requirements. Top complaints against providers relate to surprise bills and good faith estimates.”
  • Per an HHS press release,
    • “Today, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS), announced more than $1.4 billion in Ryan White HIV/AIDS Program funding for the HRSA AIDS Drug Assistance Program and related awards. This HRSA funding ensures that individuals with HIV who have low incomes receive lifesaving medication, quality HIV health care and essential support services. This announcement supports and advances the Biden-Harris Administration’s National HIV/AIDS Strategy.
    • “HRSA-supported AIDS Drug Assistance Programs pay for HIV medication, co-pays and co-insurance for HIV medication, and premiums for health insurance that covers HIV medication. This critical support helps individuals with HIV receive antiretroviral therapies, which help people reach viral suppression, meaning they cannot sexually transmit HIV and can live longer and healthier lives. Without access to lifesaving HIV medication provided by HRSA-supported AIDS Drug Assistance Programs, HIV medication could cost an individual more than $40,000 per year, putting it otherwise out of reach. HRSA supports critical HIV care and medication in all 50 states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and six U.S. Pacific territories.”
  • Federal News Network tells us,
    • “The Postal Service is facing a potential “retirement wave,” its inspector general’s office warns, with nearly one in five of its employees now retirement-eligible, and more than half its workforce eligible to retire within a decade.
    • “The USPS OIG, in its latest report, found USPS experienced no significant shortage of career employees last year, despite a tight labor market in the U.S. and record-low unemployment rates.
    • “Between fiscal years 2019 and 2023, USPS grew its workforce by more than 8,000 employees — a more than 1% growth rate. The agency employs about 637,000 total workers.
    • “The agency, however, may also need to prepare for a large contingent of its workforce to retire.”

From the public health and medical research front,

  • ABC News reports,
    • “The number of births declined in the United States in 2023, ending two years of upticks during the COVID-19 pandemic, according to a new federal report.
    • “A report published early Tuesday by the Centers for Disease Control and Prevention’s National Center for Health Statistics showed there were 3,596,017 babies born in 2023.
    • “This is a decrease of 2% from the 3,667,758 babies born in 2022 and the 3,664,292 babies born in 2021.”
  • The AP informs us,
    • “Public health experts from some of the nation’s leading research institutions have deployed a massive medical trailer to rural parts of the South to test and survey thousands of local residents. The goal: to understand why the rates of heart and lung disease are dramatically higher there than in other parts of the U.S. 
    • “This rural health disadvantage, it doesn’t matter whether you’re white or Black, it hurts you,” said Dr. Vasan Ramachandran, a leader of the project who used to oversee the Framingham Heart Study — the nation’s longest-running study of heart disease. “No race is spared, although people of color fare worse.
    • “The researchers aim to test the heart and lung function of roughly 4,600 residents of 10 counties and parishes in Alabama, Kentucky, Louisiana and Mississippi while collecting information about their environments, health history and lifestyles. They are also giving participants a fitness tracker and plan to survey them repeatedly for years to check for any major medical events.”
  • The U.S. Preventive Services Task Force made the following final recommendation today:
    • For asymptomatic pregnant adolescents and adults:
      The current evidence is insufficient to assess the balance of benefits and harms of screening for iron deficiency and iron deficiency anemia in pregnant persons.
      Grade: I statement
    • This recommendation aligns with the prior 2015 recommendation.
  • MedPage Today notes
    • “Researchers Challenge USPSTF’s Lung Cancer Screening Criteria — Alternate criteria based on years of smoking has higher sensitivity and specificity, study says.
  • Per Healio,
    • Messaging strategies led to higher support for breast cancer screening cessation [among older women].
    • Messages from multiple vs. one or no source led to higher intentions of screening cessation.
    • “One important contributor to overscreening is that patients have received pro-screening messages for many years from the media, the broader social environment and health care professionals. In contrast, there has been little messaging about the harms of overscreening, or that stopping screening may be appropriate for some women,” Eli Lilly’s LLY 3.05%increase; green up pointing triangle anti-obesity drug Zepbound significantly reduced the risk of Type 2 diabetes among people with excess weight and elevated blood-sugar levels in a new study.
    • The finding widens the list of additional health benefits beyond weight loss for a hot new crop of anti-obesity drugs. Prior studies have found that Novo Nordisk’s Wegovy reduces the risk of heart attacks and strokes, and Lilly’s Zepbound eases the severity of obstructive sleep apnea.  associate professor in the division of geriatric medicine and gerontology in the department of medicine at Johns Hopkins University School of Medicine, and colleagues wrote in JAMA Network Open. “Messaging strategies have been used successfully to reduce other unwanted health behaviors such as smoking but are an understudied approach to reduce overscreening.”
  • To top things off, the Wall Street Journal reports,
    • Eli Lilly’s anti-obesity drug Zepbound significantly reduced the risk of Type 2 diabetes among people with excess weight and elevated blood-sugar levels in a new study.
    • The finding widens the list of additional health benefits beyond weight loss for a hot new crop of anti-obesity drugs. Prior studies have found that Novo Nordisk’s Wegovy reduces the risk of heart attacks and strokes, and Lilly’s Zepbound eases the severity of obstructive sleep apnea.  * * *
    • “In the study, weekly injections of Zepbound for more than three years reduced the risk of progression to Type 2 diabetes by 94%, compared with a placebo, among people with excess weight and prediabetes, Lilly said Tuesday.
    • “The drug also led to significant weight reduction at an average of between 15% and nearly 23%, depending on the dosage, compared with the 2.1% reduction in patients who received a placebo.
    • “Some of the benefits appeared to last, however, only as long as patients were taking the drug. During a 17-week off-treatment follow-up period, patients who discontinued Zepbound began to regain weight and had some increase in the progression to Type 2 diabetes. Including the 17-week off-treatment period, patients who took Zepbound in the study had an 88% reduction in the risk of progression to Type 2 diabetes compared with the placebo.”
  • Fierce Pharma adds,
    • “Regulators in both the U.S. and Europe have looked into the potential link between suicidal thoughts and Novo Nordisk’s blockbuster semaglutide franchise after reports sounded the alarm last year. While the agencies found no increased risk for the popular diabetes and obesity drug, a new study could fuel the debate.
    • “In a study recently published in the Journal of the American Medical Association (JAMA), researchers found a “significant disproportionality” for semaglutide-associated suicidal ideation compared with other medicines, particularly among patients who also use antidepressants. 
    • “No such link was found for Novo’s earlier-generation GLP-1 med, liraglutide, according to the team. The study was based on the World Health Organization’s (WHO’s) database of suspected suicidal and self-injurious adverse drug reactions.
    • “Branded as Wegovy, Ozempic and Rybelsus, Novo’s semaglutide medicines—and their liraglutide counterparts Victoza and Saxenda—all fall under the GLP-1 umbrella.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Epic is planning to deepen its relationships with health insurance companies, the electronic health record giant said at its annual user group meeting Tuesday.
    • “The EHR company is working with health systems and large insurers such as CVS Health subsidiary Aetna, Elevance Health and multiple Blue Cross and Blue Shield plans to streamline prior authorization requests and ease provider appeals to payers, Epic founder and CEO Judy Faulkner said during a keynote address. The event was held at Epic’s headquarters in Verona, Wisconsin.
  • The Business Group on Health announced,
    • “Projected health care cost trend jumped to almost 8% for 2025, the highest amount in more than a decade, according to Business Group on Health’s 2025 Employer Health Care Strategy Survey.
    • “The predicted surge in employer health care spending – actual health care costs have grown a cumulative 50% since 2017 – comes against a backdrop of inflation, heightened demand for expensive drugs such as GLP-1s, potentially curative but high-cost cell and gene therapies, and the ongoing burden of treating cancer and other chronic conditions.
    • “Employers are steadfast in their desire to provide comprehensive offerings to their workforces,” said Ellen Kelsay, president and CEO of Business Group on Health. “They continue to absorb much of the upticks in cost and remain keenly focused on lowering spending and improving outcomes and experiences for employees. However, the foreboding cost landscape has accelerated the need for bold transformation, and employers seek partners who will make that happen.”
    • “The Business Group survey, released today in Washington, D.C., also showed that pharmacy spending was largely responsible for the increased health care trend in 2023; that GLP-1s have created challenges for employers; and that while cancer and musculoskeletal conditions remained the top two cost drivers, this year saw more employers reporting cardiovascular conditions as the third costliest.
    • “The survey gathered data on a range of critical topics related to employer-sponsored health care for the coming year. A total of 125 large employers across varied industries, who together cover 17.1 million people in the United States, completed the survey between June 3, 2024, and July 12, 2024.”
  • Per Fierce Healthcare,
    • “Mass General Brigham’s operating income slipped to $47 million for the quarter ended June 30 despite a 7% year-over-year increase in total operating revenue, the major nonprofit system reported last week.
    • “The fiscal third-quarter numbers, which reflect a 0.9% operating margin, follow the prior year’s $69 million operating income and 1.4% operating margin.
    • “When including nonoperating items such as investment income, Mass General Brigham logged a net income of $277.5 million, also down from the third quarter of 2023.
    • “The Massachusetts system is showing a slight year-over-year improvement across the first months of its 2024 fiscal year, having turned the prior year’s $5 million loss into a $41 million operating income (0.3% operating margin, not inclusive of $118 million of onetime revenue tied to prior year healthcare provider activity).”
  • Per BioPharma Dive,
    • “The Food and Drug Administration has approved a new combination drug regimen from Johnson & Johnson to treat a common type of advanced lung cancer with certain genetic mutations.
    • “J&J’s Rybrevant is now cleared for use with another drug called Lazcluze in people with previously untreated non-small cell lung cancer that’s metastasized or advanced locally. Only people with specific mutations in a gene known as EGFR are eligible for treatment.
    • “The approval is based on results from a study that compared the combination to AstraZeneca’s lung cancer drug Tagrisso. In a statement, J&J described the new treatment as the first chemotherapy-free regimen that’s demonstrated superiority to Tagrisso in this setting.”
  • Per MedTech Dive,
    • “Johnson & Johnson has agreed to acquire V-Wave, the maker of an implantable device to treat heart failure, in a deal worth up to $1.7 billion.
    • “J&J will pay $600 million upfront, plus potential additional payments up to about $1.1 billion if regulatory and commercial milestones are met, the company said Tuesday. J&J expects the acquisition to close before the end of the year.
    • “V-Wave’s device, known as the Ventura Interatrial Shunt, is designed to reduce elevated left atrial pressure in people with congestive heart failure by creating a shunt between the left and right atrium. It received the Food and Drug Administration’s breakthrough device designation in 2019 and Europe’s CE mark in 2020. J&J said the device could be the first of its kind to reach the market.”

Midweek Update

Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Wall Street Journal adds,
    • “A summer Covid wave is hitting the country, but there’s one consolation: Your chances of developing long Covid have fallen since the start of the pandemic. 
    • “That’s the finding from a new study in the New England Journal of Medicine. It concluded that about 10% of people infected with the virus’s original strain developed long Covid. By contrast, the risk of developing long Covid dropped to 3.5% with the virus’s Omicron variant among vaccinated people. For the unvaccinated, the risk was 7.7.%.
    • “Researchers defined long Covid as people who experienced persistent and debilitating symptoms such as a racing heartbeat or brain fog, or other new health problems linked to the initial illness, a month or more after their infection.
    • “About 70% of the drop in long Covid cases was due to vaccination and 30% because of changes in the virus itself, the study determined. 
    • “Four years since the start of the pandemic, we’re getting used to periodic waves of Covid cases, including the uptick we’re seeing now, driven by Omicron subvariants. The threats of severe illness and lingering health problems have significantly subsided, though they haven’t disappeared.”
  • Beckers Hospital Review reports,
    • “As the House Committee on Oversight and Accountability investigates pharmacy benefit managers regarding alleged anticompetitive practices, the committee scheduled a hearing with leaders of the top three PBMs. 
    • “On July 23, [at 10 am ET], members of the House Committee on Oversight and Accountability plan to ask executives at Express Scripts/Evernorth, CVS Caremark and OptumRx about the alleged anticompetitive policies, which committee members say raise prescription drug costs, harm independent pharmacies and obstruct patient care. 
    • “The three PBMs account for about 80% of the market share. 
    • “The called witnesses are Adam Kautzner, PharmD, president of Evernorth Care Management and Express Scripts; David Joyner, executive vice president of CVS Health and president of CVS Caremark; and Patrick Conway, MD, CEO of OptumRx.”
  • The FEHBlog discovered today that on July 11, 2024, Rep. Gary Palmer (R Ala.) introduced House Jt. Resolution 187 which reads,
    • Resolved by the Senate and House of Representatives of the United States of America in Congress assembled, That Congress disapproves the rule submitted by the Office of Personnel Management relating to Postal Service Reform Act; Establishment of the Postal Service Health Benefits Program (89 Fed. Reg. 37061), and such rule shall have no force or effect.”
  • The cited rule is the OPM’s May 2024 supplemental rule implementing the PSHBP. In the FEHBlog’s opinion, the provision of the rule which offends Rep. Palmer (and the FEHBlog) for that matter is found in an OPM FAQ:
    • “While the proposed rule reflects that Medicare Part D-eligible annuitants and their Part D-eligible family members would be automatically group enrolled into the Part D EGWP, it reflects that they may choose to opt out of receiving prescription drug coverage through the PSHB Part D EGWP. This proposed rule provides, consistent with the statute, that the Part D EGWP offered by their PSHB plan is the only PSHB prescription drug benefit available for Part D-eligible PSHB annuitants and their Part D-eligible covered family members. As proposed, Medicare Part D-eligible annuitants and their family members who choose to opt out of or disenroll from the PSHB plan’s Part D EGWP would not have access to prescription drug benefits through their PSHB plan and would not pay a lower premium than those enrolled in the Part D EGWP.
  • Nothing in the Postal Service Reform Act suggests that Congress intended to impose such a penalty. It’s a penalty because OPM does not reduce the premium for members who are deprived of their plan’s prescription drug benefits. Furthermore, when Congress included a mandate for PSHBP annuitants to enroll in Part B, it also provided grandfathering protections and exemptions. The Part D penalty applies across the board.
  • In any case, because Part D benefits will feature improvements such as a $2,000 out of pocket cost maximum for 2025, the carrot approach to incenting Part D EGWP enrollment should be tried first.
  • The American Hospital Association News lets us know,
    • “The Administration for Strategic Preparedness and Response July 16 announced it will work with the Department of Commerce on an assessment of the active pharmaceutical industrial base to better understand the pharmaceutical supply chain and how it has changed since the COVID-19 pandemic. The assessment is based on a survey conducted last winter. The study will inform federal strategies and funding decisions related to the API supply chain and raise awareness of potential supply chain issues, such as the current limited domestic manufacturing capabilities and other potential issues. The study will survey more than 200 companies, including manufacturers, distributors, suppliers and customers. A Bureau of Industry and Security webpage answers FAQs about the project.”

From the public health and medical research front,

  • STAT News tells us,
    • “The Centers for Disease Control and Prevention just released a trove of data on Americans with disabilities that found that more than a quarter of U.S. adults have a disability — over 70 million people, a bump from prior years. This slice of the population was also much more likely to report long Covid symptoms such as chronic fatigue and brain fog. This comorbidity looms large for many disabled communities as another surge in Covid cases sweeps the country.
    • “The data, gathered in 2022, is part of the agency’s Disability and Health Data System, which has annual state and national-level data stretching back to 2016. This is the first year that the agency has released long Covid data, finding that 11% of people with disabilities had long Covid symptoms while only 7% of people without disabilities reported symptoms.
    • “For many disabilities, the highest populations exist in a swath that extends from the Deep South and Louisiana up to Appalachian communities in West Virginia and Ohio. Disability benefits claims are typically highest in these areas, but for long Covid, the geography shifted west. Idaho and other states along the Continental Divide saw much higher rates of symptoms, with Montana recording the highest prevalence at 18%.”
  • The New York Times adds,
    • “A large new study provides some of the strongest evidence yet that vaccines reduce the risk of developing long Covid.
    • “Scientists looked at people in the United States infected during the first two years of the pandemic and found that the percentage of vaccinated people who developed long Covid was much lower than the percentage of unvaccinated people who did. 
    • “Medical experts have previously said that vaccines can lower the risk of long Covid, largely because they help prevent severe illness during the infection period and people with severe infections are more likely to have long-term symptoms.
    • “But many individuals with mild infections also develop long Covid, and the study, published Wednesday in The New England Journal of Medicine, found that vaccination did not eliminate all risk of developing the condition, which continues to affect millions in the United States.”
  • STAT News also informs us,
    • “A study published Wednesday in the Journal of Clinical Oncology found that certain unmatched donors, or people whose bone marrow does not as closely resemble that of the patient’s, provided similar outcomes to matched donors so long as patients receive a key drug called cyclophosphamide to prevent dangerous complications. That suggests that patients who need a transplant might be able to safely consider both matched and some unmatched donors, vastly expanding the pool of potential acceptable donors for all patients, though particularly those of African, Latino, or Asian ancestry.
    • “It’s much harder to find a match for most of my patients. Looking to people who are donor unrelated and aren’t a perfect match for my patients has become the norm,” said Sekeres, who is the chief of hematology at Sylvester Cancer Center at the University of Miami and did not work on the study. “That’s why this study really resonated with me. The classic teaching is you want a perfect match as opposed to less than perfect. What this study suggests is, if you use the right drugs after transplant, it may not be as big of a deal.”
    • “If so, up to roughly 84% of African American patients might have a potential donor in the national registry. Currently, less than 30% of African American patients have a potential match in the NMDP registry, previously called the National Marrow Donor Program.”
  • Per BioPharma Dive,
    • “A closely watched obesity pill being developed by Roche helped people in a small Phase 1 trial lose 7.3% of their body weight over four weeks when taken once daily — 6.1 percentage points more than those given a placebo, the company said Wednesday.
    • “The data comes two months after the Swiss drugmaker disclosed trial results from another obesity drug in its pipeline, which showed the once-weekly injection helped reduce body weight by 19% over six months. Roche disclosed more detailed data for that drug, indicating none of the trial participants stopped taking it due to side effects — a reason users might quit taking Wegovy or Zepbound.
    • “The two drugs came from Roche’s $2.7 billion acquisition of biotechnology startup Carmot Therapeutics in December. The deal was part of a rush by pharmaceutical companies to enter a market estimated to be worth more than $100 billion annually by early next decade.”
  • Beckers Hospital Review interviews NYU Langone’s bariatric surgery chief about the first GLP-1 generic and other GLP-1 issues.
  • Per a National Institutes of Health press release,
    • “A neuroimaging study of young people who exhibit a persistent pattern of disruptive, aggressive, and antisocial behavior, known as conduct disorder, has revealed extensive changes in brain structure. The most pronounced difference was a smaller area of the brain’s outer layer, known as the cerebral cortex, which is critical for many aspects of behavior, cognition and emotion. The study, co-authored by researchers at the National Institutes of Health (NIH), is published in The Lancet Psychiatry.
    • “Conduct disorder has among the highest burden of any mental disorder in youth. However, it remains understudied and undertreated. Understanding brain differences associated with the disorder takes us one step closer to developing more effective approaches to diagnosis and treatment, with the ultimate aim of improving long-term outcomes for children and their families,” said co-author Daniel Pine, M.D., chief of the Section on Development and Affective Neuroscience in NIH’s National Institute of Mental Health. “Critical next steps are to follow children over time to determine if differences in brain structure seen in this study are a cause of conduct disorder or a long-term consequence of living with the disorder.”
  • The National Cancer Institute posted its latest cancer information highlights.
  • The Institute of Clinical and Economic Review “releasedDraft Evidence Report assessing the comparative clinical effectiveness and value of acoramidis (BridgeBio Pharma, Inc.), tafamidis (Vyndamax®/Vyndaqel®, Pfizer Inc.), and vutrisiran (Amvuttra®, Alnylam Pharmaceuticals, Inc.) for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM).”
  • AHRQ’s Patient Safety Network informs us,
    • “Patients presenting to the emergency department (ED) are triaged to prioritize care based on level of illness. In this study, 2,543 patients presenting to an ED in Switzerland were asked to self-triage using an electronic symptom-checker. (Patients were triaged and treated based on standard-of-care nurse triage.) Recommendations were given regarding time to treat (e.g., emergency) and point-of-care (e.g., self-care) and subsequently evaluated by three panels of experts. Fifty of the 2,543 patients were judged as undertriaged, but none were judged as potentially hazardous.”

From the U.S. healthcare front,

  • Healthcare Dive points out,
    • “Elevance reported solid second-quarter results on Wednesday — including $2.3 billion in profit — but the company still lowered long-term revenue growth guidance for its health insurance business. That disconnect raised red flags for analysts.”
    • “Changing revenue growth forecasts for health benefits in the middle of the year “is unusual,” commented Jefferies analyst David Windley in a Wednesday note. “We can’t identify a single, large item that would compel [the reduction] off-cycle.”
    • “During a call with investors Wednesday, Elevance management cited several factors for dropping the guidance, including significant member losses from Medicaid redeterminations and Medicare Advantage bids for 2025 that could slow growth.”
  • Fierce Pharma reports,
    • “As myriad pharma industry attempts to challenge the Inflation Reduction Act (IRA) fall flat, Johnson & Johnson is settling into a reality of pricing rebates and Medicare drug cost negotiations.”
    • “While J&J is “not in alignment” with IRA or its price setting process, the company has accepted the reality of the situation and baked assumptions about the future costs of its drugs into its growth projections through the end of the decade, Jennifer Taubert, EVP, worldwide chairman, innovative medicine at J&J, said on an analyst call Wednesday.
    • “As it stands, J&J currently expects to grow its business by 3% next year and then 5% to 7% out through 2030, Taubert said.”
  • Per Fierce Healthcare,
    • “Electronic health record messages to patients drafted by generative AI were of similar quality and accuracy to those written by healthcare professionals, according to a newly published study conducted using queries from NYU Langone Health patients.”
    • “The analysis, headed by researchers at the system’s affiliate NYU Grossman School of Medicine, had 16 primary care physicians rate AI and human drafts without knowing how each was written.
    • “Among a sample of 334 AI-drafted messages and 169 from professionals (both physicians and non-physicians), the raters found both sets to be on par regarding informational content, completeness and whether the grader would use the draft or start again from scratch.”
    • “The findings “suggest chatbots could reduce the workload of care providers by enabling efficient and empathetic responses to patients’ concerns,” study lead William Small, M.D., of the medical school, said in a release.”

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC,

  • This morning, the Federal Trade Commission released an interim staff report on its ongoing investigation of prescription benefit managers. The report was favorably received by Senators Wyden and Grassley. Healthcare Dive summarizes the report here.
  • The FEHBlog recalls when around 2009 the State of New York went after UnitedHealthcare for offering a for profit service that provided usual, reasonable and customary rates for out-of-network providers. In a legal settlement, UnitedHealthcare transferred the service to a new not-for-profit company called Fair Health. Meanwhile most health plans had switched to the Medicare Part RBRVS pricing as base for its UCR reimbursements. Nevertheless, Fair Health is still around.
  • Today, the American Hospital Association News tells us,
    • “An op-ed published July 9 in Modern Healthcare written by AHA President and CEO Rick Pollack and Catholic Health Association President and CEO Sr. Mary Haddad discusses why nonprofit hospitals need positive margins. The commentary piece seeks to add important context and education to the conversation around nonprofit hospitals’ community benefit, tax-exempt status and other issues, arguing that positive margins are necessary to maintain basic services and advance care for all patients and communities 24/7. “Barely making ends meet or operating at a financial loss should never be the goal or an acceptable status quo for any nonprofit healthcare organization,” Pollack and Haddad write. “It’s not just bad economics; it also impedes institutions’ ability to deliver services and improve health outcomes.”
  • If the regulators are considering taking a page out of the Fair Health playbook, consider this finding from a USC-Brookings report issued last September:
    • “Pre-tax operating margins for the three largest PBMs averaged a bit more than 4% of their revenues in 2022. Since PBMs’ revenues encompass both the administrative fees charged to PBMs and payers’ net payments for claims, this implies that even completely eliminating PBMs’ margins [a no-no] would only modestly reduce payers’ drug-related costs. Achieving larger reductions would require reducing the revenue captured by pharmacies or, particularly, manufacturers. Ultimately, the amount of revenue that manufacturers capture depends principally on the extent of intellectual property protections related to drugs and whether and how the prices that drug manufacturers receive are regulated.”
  • The healthcare industry is complex, to say the least, and there are no simple answers.

From the public health and medical research front,

  • “Did you know that the U.S. Preventive Services Task Force (Task Force) has a free app called Prevention TaskForce? This app can help healthcare professionals identify which screenings, counseling interventions, and preventive medications are right for their patients. It includes all current Task Force recommendations and can be searched by specific patient characteristics, such as age, sex/gender, and selected behavioral risk factors. Download the app, on mobile or desktop, to find the preventive services that can help keep your patients healthy.”
    • “For more information and to download the app, click here.”
  • STAT News reports,
    • “In a long-awaited study, patients in Australia will soon receive an IV infusion designed to transform their own immune cells into swarms of cancer-fighting drones.
    • “The trial, announced on Tuesday by Interius Biotherapeutics, will be the first to test what’s known technically as in vivo CAR-T therapy. Researchers have long hoped the approach could provide a potentially cheaper, safer, and more scalable version of the cell therapies that are curative for some blood cancer patients but remain out of reach for many. 
    • “Interius received regulatory clearance on June 28 and will dose up to 30 patients, beginning in the fall. It beat out several competitors, including one with over $1 billion in funding, to the first-in-human trial.  
    • “There are absolutely people alive out there today that would not have been without the CAR technology,” said Dora Mitchell, Interius’ senior vice president for operations. But the therapy is still only delivered in some places in the U.S. and Europe and almost nowhere else. “The vision that catalyzed the formation of Interius was: can we bring this to the masses?”
  • Healio informs us,
    • “There is insignificant evidence to support recommendations that children with autism will benefit from intensive interventions, according to the results of a meta-analysis published in JAMA Pediatrics.
    • “One of the study’s authors told Healio that in reviewing standard intervention recommendations for autism in children, she found that one recommended that children receive at least 20 hours or up to 40 hours of intensive intervention per week.
    • “This recommendation originated initially from a quasi-experimental study conducted in the ’80s that, although remarkable for the time, was flawed,” Micheal P. Sandbank, PhD, director of The Brain and Language Lab at the University of Texas at Austin, told Healio. “There have been additional studies since then, but most were quasi-experimental and compared intensive intervention with different uncontrolled supports, failing to isolate the effect of intensity specifically from the effect of providing a systematic and comprehensive intervention approach.”
  • The Washington Post explains what to know about six popular home tests for urinary tract infections, menopause, allergies, colon cancer, A1c blood sugar and thyroid conditions.

From the U.S. healthcare business front,

  • Beckers Hospital CFO report informs us,
    • “Average hospital margins year to date remained steadfast in May at 3.8%, according to Kaufman Hall’s “National Hospital Flash Report,” released July 9.
    • “Hospital financial performance remained relatively unchanged during the month of May, and the rate of change slowed for margins and other key performance indicators, which reflects stabilization,” wrote Erik Swanson, senior vice president at Kaufman Hall.
    • “The stabilization is a positive sign for hospitals after ending the year with average margins at 1.9%. The average hospital margin shot up in January to 4.6% and then decreased slightly in February and March.
    • “From April to May, the monthly average operating margin index dipped from 4.2% to 3.7%. Operating margins increased 23% year to date over the same period last year.”
  • BioPharma Dive reports,
    • “Pfizer’s top scientist Mikael Dolsten is stepping down after leading the drugmaker’s research and development for the past 15 years, a period that includes Pfizer’s remarkable success developing a COVID-19 vaccine but ends with the company at a crossroads.
    • “On Tuesday, Pfizer said it has begun searching for a successor to Dolsten, who in 2010 became chief scientific officer as well as R&D head. The process is expected to last “probably through early next year,” Pfizer said.
    • “Dolsten will help with the search and continue to serve in his current position until a successor is in place and “any necessary transition is complete,” according to Pfizer.”

Monday Roundup

Photo by Sven Read on Unsplash

From Washington, DC,

  • Roll Call lets us know,
    • “Senate Appropriations Committee leaders have agreed to add $34.5 billion in emergency spending to their fiscal 2025 bills on top of levels agreed to in last year’s debt limit negotiations, sources familiar with the talks said Monday. 
    • “Under the pact between Senate Appropriations Chair Patty Murray, D-Wash., and ranking member Susan Collins, R-Maine, defense accounts would receive an extra $21 billion in emergency spending while nondefense programs would get $13.5 billion.” 
  • Taking a gander at reginfo.gov led the FEHBlog to discover that on July 1, the final version of the simply infeasible federal mental health parity rule changes was submitted to OIRA for its review.
  • In yesterday’s post, the FEHBlog called attention to the new CMS GUIDE program. The post noted that program details would be released in early July. What do you know? Those details were posted today. The American Hospital News tells us,
    • “The Centers for Medicare & Medicaid Services July 8 announced over 400 participants in a new model focused on improving dementia care. The Guiding an Improved Dementia Experience (GUIDE) Model began July 1 and seeks to reduce strain on unpaid caregivers as well as offer care coordination and management, caregiver education and support, and respite services. CMS will also test an alternative payment for participants delivering key support services to people with dementia, including comprehensive, person-centered assessments and care plans, care coordination, and 24/7 access to a support line. People with dementia and their caregivers will have access to a care navigator to help them access services and support, including clinical services and non-clinical services such as meals and transportation through community-based organizations.”
  • The HHS Inspector General posted an impact brief on Medicare Advantage program fraud involving its risk adjustment program. The Wall Street Journal published an article the same type of fraud today.
  • STAT News informs us,
    • “The Biden administration has appealed a decision in which a federal court jury last year sided with Gilead Sciences over the rights to a pair of groundbreaking HIV pills — and at least $1 billion in royalties may be at stake.
    • “At issue is a battle over patents for Truvada and a newer, upgraded version called Descovy — two highly effective and lucrative medications — as well as the role played by the federal government in making it possible to prevent transmission of a highly infectious disease that plagued the American public for decades.
    • “The U.S. Centers for Disease Control, which had funded academic research into HIV prevention that later formed the basis for the pills, maintained that Gilead infringed its patent rights. The U.S. Department of Health and Human Services also contended that the company refused to reach a licensing agreement despite several attempts to strike a deal.” * * *
    • “U.S. District Court Judge Maryellen Noreika narrowed the Gilead victory last March when she set aside the jury finding that CDC patents were not infringed. So the appeal filed by the U.S. Department of Justice — on behalf of HHS — refers to the only portion of the jury finding that remains, which is that the patents were invalid.”
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration is advancing its mission of ensuring the public has access to accurate, up-to-date science-based information to inform decisions about FDA-regulated medical products to maintain and improve their health. The agency is providing updated recommendations to empower industry seeking to voluntarily address misinformation about or related to their approved/cleared medical products.” * * *
    • “Specifically, the revised draft guidance, Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers, sets out a policy that supports companies that issue certain kinds of internet-based communications (“tailored responsive communications”) to address internet-based misinformation about or related to their approved/cleared medical products when that misinformation is created or disseminated by an independent third party. For example, a company might choose to use this type of communication when a celebrity, healthcare provider or influencer, not acting on behalf of the company, posts false, inaccurate and/or misleading representations of fact about the company’s approved/cleared medical product on social media. Additionally, this revised draft guidance provides companies with many examples that illustrate the types of misinformation found online that a company might choose to address with a tailored responsive communication, along with some considerations relevant to the current digital information environment.”
  • Govexec tells us,
    • “The Office of Personnel Management lost a small modicum of ground in its fight to reduce the backlog of pending retirement claims from federal employees as the agency’s backlog of cases inched back over 15,000.
    • “In June, OPM received 6,919 new retirement requests from departing federal workers, a slight increase over the 6,751 claims it received the previous month. But the agency’s pace in processing those claims fell precipitously, completing only 5,614 claims last month compared to the 8,793 it processed in May.
    • “That deficit led to OPM’s overall backlog of pending claims to climb from 14,035—an eight-year low—in May to 15,340 at the end of June. Consequently, the monthly average processing time for a retirement application ticked up four days, from 60 in May to 64 last month, though measured since the beginning of fiscal 2024, the average processing time has remained static at 61 days for four months running.”
  • The U.S. Preventive Services Task Force is celebrating its 40th anniversary. The FEHBlog is reminded that the FEHB Act will be 65 years old on September 28, 2024.

From the public health and medical research front,

  • The New York Times reports,
    • “The process for diagnosing a child with autism heavily relies on a parent’s description of their child’s behavior and a professional’s observations. It leaves plenty of room for human error.
    • “Parents’ concerns may skew how they answer questionnaires. Providers may hold biases, leading them to underdiagnose certain groups. Children may show widely varying symptoms, depending on factors like culture and gender.
    • “A study published Monday in Nature Microbiology bolsters a growing body of research that suggests an unlikely path to more objective autism diagnoses: the gut microbiome.
    • “After analyzing more than 1,600 stool samples from children ages 1 to 13, researchers found several distinct biological “markers” in the samples of autistic children. Unique traces of gut bacteria, fungi, viruses and more could one day be the basis of a diagnostic tool, said Qi Su, a researcher at the Chinese University of Hong Kong and a lead author of the study.”
  • The American Medical Association tells us what doctors wish their patient knew about heat stroke.
  • The Wall Street Journal discusses the right and wrong ways for people to snack.
    • “America is a nation of snackers. A lot of us are doing it wrong. 
    • “Noshing outside of traditional mealtimes isn’t inherently bad. A snack can stave off hunger, boost energy, provide important nutrients and keep us from overeating later. But snacking can also lead us to eat extra calories and overdo it on sodium, added sugars and saturated fats, which can raise our risk of heart disease and obesity. 
    • “How to snack better? Reach for food combinations that keep you fuller longer: Pair carbs like apple slices with protein and fats, like peanut butter. Or try yogurt with berries. Then plan your snack times, and watch out for the minefield that is evening snacking.”
  • The Washington Post and Consumer Reports offer information about “an aggressive tick species spreading across the U.S. Lone star ticks don’t spread Lyme disease, but they can transmit other serious diseases and are linked to a mysterious meat allergy. And the threat is growing.”
    • “Lone star ticks have long been firmly established in the Southeastern United States. In recent decades, however, their numbers have been increasing in Midwestern and Northeastern states. Between 2017 and 2021, according to CDC data, nearly half of reported ehrlichiosis cases were in five states: Arkansas, Missouri, New York, North Carolina and Tennessee.”
  • The CDC has posted FAQs on infertility. “This page has definitions and frequently asked questions related to infertility. It has important information about infertility, including common misconceptions, risk factors, and treatment options.”
  • Beckers Hospital Review points out,
    • “GLP-1 drugs such as Ozempic and Wegovy may lower the risk of developing certain obesity-related cancers, according to a new study from researchers at Case Western Reserve University in Cleveland. 
    • “Researchers found people with type 2 diabetes who were being treated with the medications were significantly less likely to develop 10 of 13 obesity-associated cancers than those taking insulin, according to the findings published July 5 in JAMA Network Open. The retrospective study is based on an analysis of the medical records of over 1.6 million type 2 diabetes patients from 2005 to 2018.
    • “The risk was reduced by more than half for gallbladder cancer, meningioma, pancreatic cancer and hepatocellular carcinoma. Esophageal, colorectal, endometrial, ovarian, multiple myeloma and kidney were among the other cancers for which there was a significant risk reduction. The study did not find a difference in cancer risk reduction among those treated with GLP-1s compared with those taking metformin, an older diabetes drug. 
    • “In an interview with Bloomberg, Arif Kamal, MD, chief patient officer at the American Cancer Society and who was not involved in the research, called the new evidence on GLP-1s “compelling.”
  • Per Fierce Pharma,
    • “In examining the electronic records of more than 18,000 overweight or obese adults in the United States, health data analytics company Truveta found that Lilly’s tirzepatide helped patients lose more weight than Novo’s semaglutide, with the effects growing over time.
    • “Results of the study, which looked at data from May of 2022 and September of 2023, were published Monday in the JAMA Internal Medicine monthly review.
    • “”After use of tirzepatide for three months, patients lost an average of 5.9% of their body weight compared to 3.6% for semaglutide. Over a year’s time, those on tirzepatide lost an average of 15.3% of their body weight compared to 8.3% for semaglutide users.
    • Additionally, tirzepatide patients were much more likely to lose 15% of their body weight than those using semaglutide. While 42% of those on tirzepatide reached the benchmark after one year of treatment, only 18% of those on semaglutide could say the same. 
    • “Lilly’s tirzepatide is the active ingredient found in its diabetes product Mounjaro and its obesity treatment Zepbound, while Novo’s semaglutide is the compound used to make its diabetes blockbuster Ozempic and its obesity follow-on Wegovy.
    • “Importantly, the Truveta study looked at the drugs that are approved for diabetes. The authors noted that “future studies are needed to compare versions labeled for weight loss.”
  • Per an NIH press release,
    • “A series of experiments with highly pathogenic H5N1 avian influenza (HPAI H5N1) viruses circulating in infected U.S. dairy cattle found that viruses derived from lactating dairy cattle induced severe disease in mice and ferrets when administered via intranasal inoculation. The virus from the H5N1-infected cows bound to both avian (bird) and human-type cellular receptors, but, importantly, did not transmit efficiently among ferrets exposed via respiratory droplets. The findings, published in Nature, suggest that bovine (cow) HPAI H5N1 viruses may differ from previous HPAI H5N1 viruses and that these viruses may possess features that could facilitate infection and transmission among mammals. However, they currently do not appear capable of efficient respiratory transmission between animals or people.”
  • MedPage Today lets us know,
    • “Extended-release 7-day injectable buprenorphine was safe and tolerable for most patients who had minimal-to-mild opioid withdrawal, a nonrandomized trial found.
    • “Among 100 adult patients with minimal-to-mild opioid withdrawal scores who were given a 24-mg dose of extended-release buprenorphine, only 10 people (10%, 95% CI 4.9%-17.6%) saw a 5-point or greater jump in withdrawal symptoms within 4 hours of injection, reported Gail D’Onofrio, MD, of the Yale School of Medicine in New Haven, CT, and colleagues.” * * *
    • “The study examined whether patients with untreated opioid use disorder (OUD) and minimal-to-mild withdrawal could tolerate a 7-day dose of buprenorphine. Patients with OUD typically aren’t treated with medication until they are in significant withdrawal, due to fear of precipitated withdrawal. For that reason, “[n]o one has ever even attempted to give buprenorphine in that [0 to 7] range,” D’Onofrio said.” * * *
    • “[This is a real game-changer for emergency physicians and clinicians, even in the clinic, who would be able to induce people on buprenorphine much earlier than they previously could have,” D’Onofrio said.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY has agreed to buy biopharmaceutical company Morphic Holding MORF for $3.2 billion in a deal that bolsters the drugmaker’s immunology pipeline.
    • “Eli Lilly on Monday said it would pay $57 a share for Morphic, a 79% premium to Friday’s closing price of $31.84 for the Waltham, Mass., company.
    • “Morphic is developing therapies for the treatment of serious chronic diseases, with a lead program targeting the inflammatory bowel diseases ulcerative colitis and Crohn’s disease.
    • “Eli Lilly late last year won U.S. Food and Drug Administration approval of its Omvoh treatment for moderately to severely active ulcerative colitis in adults.
    • “Indianapolis-based Eli Lilly said it expects to complete the acquisition, which isn’t subject to any financing conditions, in the third quarter.”
  • Modern Healthcare relates,
    • “More than half of people surveyed would feel just as safe getting hospital-level care at home as they would in a facility, according to the University of Southern California’s Schaeffer Center for Health Policy and Economics.
    • “Healthcare systems across the country are placing big bets on hospital-at-home programs, pushing access to more rural communities and lobbying state Medicaid programs to reimburse for the service. A Centers for Medicare and Medicaid Services waiver reimbursing for acute care at home expires at the end of this year, but bipartisan members of Congress are backing legislation that would provide Medicare reimbursement for another five years. More than 330 hospitals across 37 states offer hospital-level care at-home programs through the CMS Acute Hospital Care at Home waiver.” * * *
    • “The survey did not require participants to have prior experience with hospital-level care at home or knowledge of the service. It did provide participants with a brief explanation of how hospital-at-home programs operate.”
  • Per Fierce Healthcare,
    • “A recent proposal to report prior authorization to insurance plans through CPT codes was withdrawn at the eleventh hour when its physician advocate made an unexpected discovery: For certain codes and in very narrow circumstances, the prior auth requirements were already in place.
    • “Alex Shteynshlyuger, M.D., director of urology with New York Urology Specialists, had previously brought forward a time-based proposal that would ensure physicians are compensated for time spent on prior auth claims. He believed the changes would also reduce the number of claim requirements imposed by plans and limit the amount of appeals and could lead to better patient outcomes.
    • “Following the proposal, however, the American Medical Association (AMA) informed Shteynshlyuger that prior authorization is already explicitly mentioned in official procedure descriptions for half a dozen CPT codes. This required Shteynshlyuger to withdraw the proposal so he could revise and resubmit at a later date.
    • “Each CPT code includes a short description detailing the type of visit or examination. Longer descriptions—where the prior auth mentions were contained—are also stored in databases that can be purchased, but those are rarely encountered.
    • “As a matter of fact, I’ve never seen the long description in my lifetime,” said Shteynshlyuger.”
  • and
    • “Nearly 5 million fewer people delayed care from 2019 to 2022, a study from the Urban Institute with funding from the Robert Wood Johnson Foundation revealed.
    • “The study shows 4.75 million non-elderly Americans skipped necessary medical care, dropping from 12.1% to 9.7% in 2022.
    • “For families below 138% of the federal poverty line, there was a 27% reduction in cost barriers. A 19% reduction was evident for families between 138% and 249% of the federal poverty line.
    • “Researchers say these outcomes are a direct result of the Medicaid continuous coverage requirements and enhanced tax credits.
    • “Our findings show significant improvements in health insurance coverage and healthcare access under federal and state policy changes enacted during the public health emergency,” said Michael Karpman, principal research associate at the Urban Institute, in a statement. “The continued unwinding of the Medicaid continuous coverage requirement and the potential expiration of enhanced Marketplace subsidies after 2025 could make these gains in coverage and access difficult to sustain.”

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC,

  • KFF Health News reports,
    • “U.S. Surgeon General Vivek Murthy declared firearm violence a public health crisis, as gun deaths and injuries punctuate daily life in America.
    • “On nearly every day of 2024 so far, a burst of gunfire has hit at least four people somewhere in the country. Some days, communities have endured four or five such shootings.
    • “The nation’s top doctor called on policymakers to consider gun safety measures such as bans on assault weapons and high-capacity ammunition magazines and universal background checks for all firearm purchases. His advisory also urges a “significant increase” in funding for research on gun injuries and deaths, as well as greater access to mental health care and trauma-informed resources for people who have experienced firearm violence.”
  • NPR discusses what the declaration will do.
  • The U.S. Public Health Service Task Force issued a draft recommendation today which “concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for food insecurity on health outcomes in the primary care setting.” The public comment period ends on July 22, 2024.
  • Reg Jones, writing in FedWeek, explains “Earning, Accumulating and Using Sick Leave in the Federal Government.”

From the public health and medical research front,

  • The Washington Post reports,
    • “The Centers for Disease Control and Prevention warned clinicians, health authorities and the public Tuesday about an increased risk for dengue virus infections in the United States because of the record-breaking global incidence of the mosquito-borne viral disease.
    • “In the first six months of 2024, countries in the Americas have reported more than 9.7 million dengue cases, twice as many as in all of 2023, exceeding the highest number ever recorded in a single year, the CDC said in a health advisory. Puerto Rico declared a public health emergency because of the unusually high number of cases reported in the winter and spring, the dry season, when dengue cases are typically low.
    • “Since January, 745 dengue cases have been identified among U.S. travelers who became infected abroad, the agency said. Dengue cases typically increase during the warmest months that are yet to come. Last year, there were 1,829 travel-associated cases in the U.S. * * *
    • “With increased global and domestic incidence of dengue, the CDC is urging health-care providers to be on the lookout for dengue among people with fever who have been in areas with dengue transmission within 14 days of the start of illness. Infants, pregnant people, adults over 65 years old and people with certain medical conditions are at increased risk for severe dengue.”
  • Beckers Hospital Review lets us know,
    • “Teva Pharmaceuticals is launching the first authorized generic of Victoza, the first generic GLP-1 product available in the United States.
    • “By launching an authorized generic for Victoza (liraglutide injection 1.8mg), we are providing patients with type 2 diabetes another option for this important treatment,” Ernie Richardsen, SVP, Head of U.S. Commercial Generics at Teva, said in a June 24 news release.”
  • Highlighting the importance of a generic GLP-1 product is this Wall Street Journal article reporting that
    • Blockbuster obesity drug Wegovy has been approved in China, opening the door for maker Novo Nordisk to begin selling it in the world’s second-largest economy, where the appetite for similar treatments is surging. * * *
    • “Novo Nordisk’s Ozempic drug—which contains the same semaglutide active ingredient as Wegovy—was approved to treat diabetes in China in 2021. Sales of the drug in the country more than doubled on year in 2023, reaching 4.82 billion Danish kroner ($693.6 million).
    • “Demand for weight-loss drugs is surging in China, where the proportion of overweight and obese adults reached almost 51% in 2022, creating a frenzy among local manufacturers to develop their own versions of the popular treatments, especially as Novo Nordisk’s semaglutide patent expires there in 2026, which will pave the way for generic versions.”
  • MedPage Today notes,
    • “Disrupted circadian rhythms in cognitively normal adults were tied to higher subsequent amyloid-beta levels, prospective data showed.
    • “Higher daily variability at baseline — an indicator of fragmented 24-hour activity rhythms — was associated with higher PET amyloid burden 8 years later (β=0.15, P=0.02) after adjusting for age, sex, APOE4 status, and other factors, according to Julia Neitzel, PhD, of Erasmus University Medical Center in Rotterdam, the Netherlands, and co-authors. * * *
    • “Considerable interest surrounds the role of sleep dysfunction in the development of Alzheimer’s disease and dementia,” observed Matthew Pase, PhD, of Monash University in Victoria, Australia, who wasn’t involved with the study.
    • “If poor sleep contributes to dementia, improving sleep symptomatology could be one strategy to lower dementia risk,” he told MedPage Today.
  • NPR discusses why “Your gut microbes may influence how you handle stress.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “The University of Alabama System’s board of trustees unanimously approved an agreement to acquire Ascension St. Vincent’s Health System.
    • “Birmingham-based UAB will assume ownership of all Ascension St. Vincent’s care sites under the agreement, announced June 25. The transaction still needs approval from federal regulators and the Catholic Church. UAB and Ascension expect the $450 million deal to close in the fall of 2024, according to the Shelby County Reporter.
  • and
    • identifies the twenty most socially responsible hospitals in the U.S., per Lown Institute. Duke Regional Hospital, in Durham, NC, leads the pack.
  • Per Fierce Pharma,
    • “Physicians don’t mind patients choosing at-home testing options over coming in for an in-person clinic visit—in fact, they overwhelmingly support it, according to the results of a new survey.
    • “Ixlayer’s report this week is based on a poll of more than 140 U.S. physicians representing a variety of specialties. All together, nearly 90% agreed that at-home tests are more convenient to many patients and can improve access to diagnostic care, and almost as many said they believe offering at-home testing options can help speed up diagnoses and, ultimately, improve patient outcomes.
    • “There is a large subset of my patients where making routine office visits is difficult, either complicated by age, travel time, costs, or time constraints. So I see having a convenient, at-home solution as a plus for improving medical care,” one of the survey’s respondents said.
    • “The overwhelming majority of the doctors surveyed, 91% of the group, said they were open to providing at-home testing kits to their patients, and 80% agreed that the remote tests could support or even enhance the healthcare system’s existing workflows.

Friday Factoids

Photo by Sincerely Media on Unsplash

From Washington, DC,

  • STAT News reports,
    • “A House panel is exploring holding a vote on scaled-back versions of two major health care bills that would expand Medicare’s coverage of cancer screening tests and hugely popular weight loss drugs, five sources familiar with the planning told STAT. * * *
    • The two pieces of legislation are the Treat and Reduce Obesity Act, which would allow Medicare to cover obesity drugs and enable more health care providers to provide intensive behavioral therapy for obesity to Medicare patients, and the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, which would allow Medicare to cover multi-cancer blood tests to screen healthy people for cancer. * * *
    • “Full Medicare coverage for both items has broad bipartisan support, but the expansion has been hampered by the likely exorbitant price tags to the federal government. If the House Ways and Means Committee is able to scale back the measures to a more palatable price point, it could increase their chance of passage.
    • “It is unclear how the bills could be limited to decrease their cost, and whether such pared-down proposals could achieve the bipartisan support that would be necessary to make the bills candidates for inclusion in a health care package that’s expected at the end of the year.”
  • BioPharma Dive informs us,
    • “Peter Marks is again at the center of a controversial Food and Drug Administration decision on a gene therapy for Duchenne muscular dystrophy. Twice now, the high-ranking FDA leader has pushed aside objections from agency reviewers to grant an approval to Sarepta Therapeutics’ treatment for the muscle-wasting condition.
    • “On Thursday, the FDA substantially broadened use of that treatment, called Elevidys. The decision makes Elevidys available to approximately 80% of people in the U.S. with Duchenne, which has limited treatment options and no cure. The agency also converted Elevidys’ accelerated approval to full, securing its place on the market. Previously, Elevidys was only approved for a specific group of boys 4 or 5 years of age.
    • “[D]ocuments published by the FDA expose a rift within the agency over Elevidys. Three FDA review teams and two top officials recommended Sarepta’s application be rejected due to insufficient and conflicting clinical data. They were overruled by Marks, head of the FDA center that reviews gene therapies, who found the results supportive enough to broaden Elevidys’ label. It’s now cleared for Duchenne patients over the age of 4 with mutations to a specific gene, regardless of whether they can still walk.
    • “I come to a different conclusion regarding the overall interpretation of the data,” Marks wrote in a memo. * * *
    • “The lasting impact of the approval will likely shape the FDA and gene therapy space for some time,” wrote Tim Lugo, an analyst at the investment bank William Blair, in an investor note Thursday. “We believe a more patient focused and less adversarial FDA review process is likely to continue across several areas in the agency, especially for heterogenous and deadly diseases with few good treatment options.”
  • This morning, the 5th Circuit issued in its opinion in a case challenging the authority of the U.S. Preventive Services Task Force (USPSTF) to make binding preventive services recommendations under the Affordable Care Act. The Court agreed with the lower court that USPSTF members are principal officers of the U.S. due to the binding nature of their recommendations. (HHS argued unsuccessfully that they were inferior officers.). Under the Constitution, the President must appoint principal officers with the advice and consent of the Senate. 
  • The Court granted relief to the individual plaintiffs but rejected the district court’s grant of universal injunction against enforcement of USPSTF recommendations since ACA enactment. The Court remanded the case to the district court for further proceedings.
  • The political ball is in the Biden Administration’s court.

From the public health and medical research front,

  • The Centers for Disease Control tells us,
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in some areas.
    • COVID-19
      • “COVID-19 test positivity has increased to 6.6% from 5.4% in the previous week. Emergency department visits for COVID-19 are also increasing nationally. Wastewater viral activity is showing increases in some states. We also estimate that COVID-19 infections are growing or likely growing in 39 states and territories, declining or likely declining in 0 states or territories, and are stable or uncertain in 10 states and territories, based on CDC modeled estimates of epidemic growth. KP.3 and LB.1 are projected to continue increasing as proportions of the variants that cause COVID-19 (CDC COVID Data Tracker: Variant Proportions).
    • “Influenza
    • RSV
      • “Nationally, RSV activity remains low.
    • Vaccination
  • Health Day lets us know,
    • “A medication used to manage type 2 diabetes has been found effective in treating sleep apnea.
    • “The worldwide clinical trial demonstrates that tirzepatide significantly lowers breathing interruptions during sleep, a key indicator of the severity of a patient’s obstructive sleep apnea (OSA).
    • “Tirzepatide is one of the class of blockbuster GLP-1 medicines, sold as Mounjaro to fight diabetes and as Zepbound to help with weight loss.
    • “This study marks a significant milestone in the treatment of OSA, offering a promising new therapeutic option that addresses both respiratory and metabolic complications,” said study leader Dr. Atul Malhotra, director of sleep medicine at UC San Diego Health. * * *
    • “The findings, published June 21 in the New England Journal of Medicine, add to evidence that a drug targeting both apnea and obesity is better than treating either condition on its own. Researchers said the drug therapy improved other aspects related to OSA, such as improving weight. Some patients, however, had mild stomach issues.”
  • Medscape notes, “Individuals on an intermittent-fasting and protein-pacing (IF-P) diet had fewer gastrointestinal symptoms and increased diversity in gut microbiota than those on a calorie-restricted (CR) Mediterranean-style diet in a small, randomized trial.”
  • The Assistant Secretary of Labor for Employee Benefit Security writes in her blog that “For Men, Taking Care of Your Family Means Taking Care of Yourself.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Risant Health, a nonprofit formed under Oakland, Calif.-based Kaiser Permanente, has signed a definitive agreement to acquire Greensboro, N.C.-based Cone Health.
    • “The news comes less than three months after Risant acquired its first health system, Danville, Pa.-based Geisinger Health. 
    • “If the transaction closes, Cone Health will operate independently as a regional and community-based health system under Risant, which supports organizations with technology and services to improve outcomes and lower care costs in diverse business models.
    • “Cone Health’s impressive work for decades in moving value-based care forward aligns so well with Risant Health’s vision for the future of healthcare. Their longstanding success and deep commitment to providing high-quality care to North Carolina communities make them an ideal fit to become a part of Risant Health,” CEO, Jaewon Ryu, MD, said in a June 21 news release. “We will work together to share our industry-leading expertise and innovation to expand access to value-based care to more people in the communities we serve.” 
    • “Cone Health includes four acute-care hospitals, a behavioral health facility, three ambulatory surgery centers, eight urgent care centers and more than 120 physician practices, according to its website. It has more than 13,000 employees and over 700 physicians, along with 1,800 partner physicians.” 
  • Per Healthcare Dive,
    • “Steward Health Care this week pushed back the auction timeline for the sale of its physician group and about half of its hospitals — less than a week before bids were due.
    • “The delay impacts the sale of Arizona and Massachusetts hospitals as well as the St. Joseph Medical Center in Texas. The new deadline for bids is July 15, with an auction following July 18 and a proposed sales hearing on July 31. Steward did not change the timeline for the sale of its other assets.
    • “One expert told Healthcare Dive it was “very possible” Steward would delay the sale timeline again if creditors agreed it was the best business move — especially since the company just re-upped its debtor-in-possession financing, which provides cash to fund operations through restructuring.”
  • and
    • “Telehealth use declined across most sociodemographic groups from 2021 to 2022, according to a survey published Thursday by the National Center for Health Statistics.
    • “Thirty-seven percent of adults reported using telemedicine in the past 12 months in 2021, compared with just over 30% in 2022.
    • “Researchers noted the decline across nearly all groups studied, including sex, family income, education and region. Women, adults with at least a college degree and people living in more urban areas were more likely to use telehealth in 2022.” 
  • Per Fierce Healthcare,
    • “An innovation council brought together some of the nation’s largest health plans to raise issues and look for ways to improve complex processes, including credentialing and provider data management.
    • “It’s one of the first times payers have sat down together to solve these pain points, CAQH CEO Sarah Ahmad told Fierce Healthcare in an interview. The health plan representatives met in-person just one day before AHIP 2024 kicked off in Las Vegas last week.
    • “You don’t see that in healthcare these days,” said Ahmad, whose company assembled the leaders.
    • “CAQH is a provider data management company that works on the provider side to credential and handle directory management, and on the member side to handle coordination of benefits.”
  • HR Dive offers five stories on the rise of wellness benefits.