Friday Factoids

U.S. Healthcare

Friday Factoids

David Ermer–AHRQ, CDC, COVID-19, FDA, Medicare, Mental health care, NCQA, No Surprises Act, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Bloomberg News reports,
    • “Federal agencies are aiming to issue final regulations this year that aim to make the arbitration process more efficient for No Surprises Act health care payment disputes, an IRS official said.
    • “The regulations are a priority for the Treasury, Labor, and Health and Human Services departments, said IRS Office of Chief Counsel Senior Technician Reviewer Kevin Knopf during a Thursday panel at the Federal Bar Association’s Insurance Tax Seminar.
    • “The proposed rules aim to reduce certain administrative fees tied to participating in an independent dispute resolution system that arbitrates clashes between medical providers and health insurers over payments. They also aim to clarify requirements to prove that a dispute is eligible for the dispute resolution process.” 
  • The Department of Health and Human Services (“HHS”) announced,
    • “Today, on National Heat Awareness Day, the U.S. Department of Health and Human Services (HHS) is launching a new tool to help communities prepare for extreme heat and prevent heat-related illness, especially among those most at risk. The Heat and Health Index (HHI) is the first nationwide tool to provide heat-health outcome information at the ZIP code level. The HHI will help state and local officials identify communities, at the zip code level, most likely to experience negative health outcomes from heat, ensure that outreach and medical aid reach the people who need it most, and help decision-makers prioritize community resilience investments.”
  • The National Committee for Quality Assurance released a fact sheet about Mental Health Awareness Month, which ended today.
  • HHS’s Agency for Health Research and Quality tells us,
    • “As we round out Older Americans Month, it is crucial that we continue to recognize the significant contributions of older adults and the urgent need to transform and improve their healthcare. Our current system is ill-equipped to meet the complex needs of older adults, who often contend with multiple chronic conditions. This inadequacy leads to fragmented and sub-optimal care, resulting in poor health outcomes, avoidable adverse events, hospitalizations, institutionalization, and increased costs. 
    • “To meet these challenges, AHRQ remains committed to using its research capabilities to build the evidence base and identify solutions ready for action. To do so, the agency has released a Special Emphasis Notice to announce its strong interest in funding health services research to improve care quality for older adults.  Research proposals for enhancing service access, delivery, organization, and equitable distribution are welcome. In particular, AHRQ seeks research to address critical questions related to the development, implementation, evaluation, and scalability of person-centered models of care to optimize older adults’ physical and mental health, functional status, and overall well-being.” 
  • BioPharma Dive informs us,
    • The Food and Drug Administration on Friday approved a third vaccine for respiratory syncytial virus, clearing a shot from biotechnology company Moderna one year after granting a green light to vaccines from GSK and Pfizer.
    • The vaccine, dubbed mResvia, is for the prevention of disease caused by respiratory syncytial virus, or RSV, in adults 60 years of age and older. Experts from the Centers for Disease Control and Prevention are expected to meet next month to provide recommendations on the shot’s use. Moderna had said it expects the vaccine to be available in time for the fall immunization season in the U.S.
  • The Centers for Disease Control (CDC) adds,
    • “The RSV vaccine is not currently an annual vaccine, meaning people do not need to get a dose every RSV season. Currently, CDC recommends only a single dose of RSV vaccine for adults ages 60 and older, using shared clinical decision-making. Additional surveillance and evaluation activities are ongoing to determine whether older adults might benefit from receiving additional RSV vaccines in the future. So far, RSV vaccines appear to provide some protection for at least two RSV seasons.”

From the public health and medical research front,

  • HHS posted a “Fact Sheet: In Response to H5N1, HHS and USDA Focus on Protecting Farmworkers.” For more information on the ongoing response, please visit FDA, CDC, and USDA’s ongoing H5N1 update pages.
  • STAT News reports,
    • “There are a lot of reasons why updated data on Pfizer’s Lorbrena, a treatment for non-small cell lung cancer, might not seem to be a big deal. The results are an update on the clinical trial that resulted in the Food and Drug Administration granting Lorbrena full approval in 2021, so in a sense they are not even that new. For Pfizer investors, Lorbrena isn’t that big a deal, either. The medicine, for patients whose lung tumors have particular genetic mutations, generated only $575 million last year — an amount that is up 57% from the year prior, but that still constitutes only 1% of the drug giant’s annual sales.
    • “But there is one number that makes the Lorbrena data quite eye-catching: In the updated data, the daily pill decreased the risk that cancer would progress or that a patient would die by 81% over five years.
    • “That’s a stunning number, especially when one considers that Lorbrena was not being compared to an inert placebo but to Xalkori, another Pfizer targeted cancer drug.
    • “Put a different way, 60% of the patients who received Lorbrena were alive and had not seen their tumors progress in the five years of the study, compared to 8% who received Xalkori.
    • “The data are being presented at the annual meeting of the American Society of Clinical Oncology and published in the Journal of Clinical Oncology.“
  • BioPharma Dive informs us,
    • “People with chronic myeloid leukemia, a simmering cancer of the bone marrow, are often treated with one of several targeted drugs that, over the past two decades, have helped to substantially prolong survival from the disease.
    • “Study results revealed Friday suggest that Scemblix, the newest of those therapies, can be both safer and more effective, potentially supporting wider use of it as an initial treatment. The results are from a late-stage clinical trial run by Scemblix’s maker, Novartis, and will be presented at the American Society of Clinical Oncology’s annual meeting.
    • “In the trial, dubbed ASC4FIRST, Scemblix led to treatment responses in significantly more participants than did other targeted drugs, which included the mainstay therapy Gleevec as well as more recently introduced medicines. Additionally, more people given Novartis’ drug experienced what’s called a “deep molecular response,” which over time can be considered a remission and allow treatment to be stopped.
    • “Study researchers also reported “markedly favorable safety and tolerability” for Scemblix, compared to Gleevec and the other so-called kinase inhibitors it was tested against.”
  • Medscape notes,
    • A personalized diet, created by integrating microbiome analysis with artificial intelligence (AI) algorithms, is a promising approach to the management of irritable bowel syndrome(IBS) symptoms, leading to enhanced symptom relief and greater gut microbiome diversity than a standard low–fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet, new research suggests.
  • and
    • “About 9 out of 10 people will have a genetic difference in their DNA that can impact how they respond to common medications,” said Emily J. Cicali, PharmD, a clinical associate at the University of Florida College of Pharmacy, Gainesville, Florida.
    • “Cicali is the clinical director of UF Health’s MyRx, a virtual program that gives Florida and New Jersey residents access to pharmacogenetic (PGx) tests plus expert interpretation by the health system’s pharmacists. Genetic factors are thought to contribute to about 25% or more of inappropriate drug responses or adverse events, said Kristin Wiisanen, PharmD, dean of the College of Pharmacy at Rosalind Franklin University of Medicine and Science in North Chicago, Illinois.
    • “Pharmacogenetics helps consumers avoid drugs that may not work well for them or could cause serious adverse events. It’s personalized medicine,” Cicali said.
    • “Through a cheek swab or blood sample, the MyRx program — and a growing number of health system programs, doctors’ offices, and home tests available across the United States — gives consumers a window on inherited gene variants that can affect how their body activates, metabolizes, and clears away medications from a long list of widely used drugs.”
  • The Wall Street Journal recounts the experiences of readers months after stopping GLP-1 drug treatment.

From the U.S. healthcare business front,

  • The Employee Benefit Research Institute relates.
    • According to findings of the Employee Benefit Research Institute (EBRI)/Greenwald Research Consumer Engagement in Health Care Survey, most plan enrollees are satisfied with their health plan, but high-deductible health plan (HDHP) enrollees are less likely to be extremely or very satisfied than traditional plan enrollees.
    • HDHP and traditional plan enrollees are both satisfied with the quality of care received and choice of doctors.
    • Differences in overall satisfaction may be driven by cost sharing. HDHP enrollees are less likely than traditional plan enrollees to be extremely/very satisfied with out-of-pocket expenses for prescription drugs and other health care services.
  • Beckers Hospital Review reports,
    • “The Justice Department has rejected bankrupt Dallas-based Steward Health Care’s suggested auction timeline for its physician group Stewardship Health to be sold to UnitedHealth Group’s subsidiary Optum. 
    • “In a May 28 bankruptcy court filing, obtained by Becker’s, Brian Boynton, principal deputy attorney general for the justice department, detailed how the debtor-in-possession financial deal between Steward and its landlord Medical Properties Trust interferes with the health system’s “obligation to comply with the United States’ antitrust review” of the Stewardship Health, Optum deal and should not be approved.”
  • and calls attention to an American Hospital Association report identifying the inpatient and outpatient services that are biggest money losers for hospitals.
  • Healthcare Dive points out,
    • “Most of the nation’s leading nonprofit healthcare providers reported progress toward financial recovery during earnings for the quarter ended March 31.
    • “However, improvements varied widely by health system, and the industry at large has a long way to go before it is back to profitability levels enjoyed pre-pandemic — if it fully rebounds at all, analysts told Healthcare Dive.
    • “Nonprofits struggled with cost challenges, confirming reports from analysts at credit rating agencies Moody’s Ratings and Fitch Ratings that predicted expenses, particularly labor costs, would continue to vex providers in 2024.
    • “Analysts also expected this year to bring a bifurcated financial recovery for the sector, where health systems that could successfully contain costs would recover more quickly.
    • “With early financial data now in for 2024, that expectation appears to be playing out.”

Thursday Miscellany

David Ermer–CDC, CMS, Medical / Rx research, Mental health care, NIH, Telehealth, U.S. Healthcare, Wellness–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Department of Health and Human Services announced,
    • Today the U.S. Department of Health and Human Services, through its Administration for Community Living, released “Aging in the United States: A Strategic Framework for a National Plan on Aging – PDF.” The report lays the groundwork for a coordinated effort – across the private and public sectors and in partnership with older adults, family caregivers, the aging services network, and other stakeholders – to create a national set of recommendations for advancing healthy aging and age-friendly communities that value and truly include older adults. The national plan on aging will advance best practices for service delivery, support development and strengthening of partnerships within and across sectors, identify solutions for removing barriers to health and independence for older adults, and more. Developed by leaders and experts from 16 federal agencies and departments working together through the Interagency Coordinating Committee (ICC) on Healthy Aging and Age-Friendly Communities, the report also reflects input from community partners and leaders in the aging services network.
  • The Assistant Secretary of Labor for Employee Benefit Security, Lisa Gomez, reminds us,
    • “May is Mental Health Awareness Month, reminding us of the critical need to prioritize mental well-being – especially in the workplace where many spend a significant portion of their time. Did you know that more than 1 in 5 adults in America live with a mental illness? Mental health issues can affect job performance, relationships and overall well-being. Understanding your rights and support systems can make a world of difference. 
    • “Here are three actions you can take to get the mental health care you deserve through your job-based health plan: 
    • “Use your benefits: * * * For more information, read our publication “Understanding Your Mental Health and Substance Use Disorder Benefits.”
    • “Don’t take no for an answer: * * * You also can look at our publication “Filing a Claim for Your Benefits” for steps to help navigate this process. 
    • “Contact the Department for help:  Know that support for your mental health journey is available – you don’t have to go through it alone. One source of support is found by contacting a benefits advisor with the Department’s Employee Benefits Security Administration at askebsa.dol.gov or by calling 1-866-444-3272 for assistance with any questions or problems you encounter when trying to use the mental health and substance use disorder benefits under your job-based health plan. The benefits advisors can help you understand your rights, your health plan and its appeal process.”
  • The American Hospital News lets us know,
    • “The Centers for Disease Control and Prevention May 29 published a blog co-authored by AHA, the National Institute for Occupational Safety and Health and the Agency for Healthcare Research and Quality, highlighting efforts by federal agencies and the hospital field to address the mental health and well-being of health care workers following incidents of workplace violence. The blog contains several resources, such as AHA’s Hospitals Against Violence Initiative, the Building a Safer Workplace and Community infographic, and information about #HAVhope Friday on June 7 * * *.
  • HR Dive informs us,
    • “Employers run afoul of federal law when they fire someone for not disclosing a disability during a job interview or for waiting until after they were hired to ask for an accommodation, the U.S. Equal Employment Opportunity Commission warned in a May 21 lawsuit.
    • “Per the complaint in EEOC v. All Day Medical Care Clinic, LLC, on her first day of work, a scheduling assistant for a Maryland-based healthcare provider notified the CEO she had a vision impairment and needed a magnifier and Zoomtext software as an accommodation. The CEO allegedly advised her that things would have been different if she’d mentioned her disability and accommodation needs during her interview and told her to leave, according to court documents.
    • “The EEOC sued the healthcare provider for allegedly violating the Americans with Disabilities Act. Under the ADA, “job applicants do not need to reveal their disabilities before being hired,” Debra Lawrence, regional attorney for the EEOC’s Philadelphia district office, explained in a press release. “When an employer penalizes an employee for not raising issues of disability and reasonable accommodation, it is requiring the employee to reveal information the employee legally does not have to divulge,” Lawrence said. All Day Medical Care did not respond to a request for a comment prior to press time.”

From the public health and medical research front,

  • The New York Times reports,
    • “A third farmworker in the United States has been found to be infected with bird flu, heightening concerns about an outbreak among dairy cattle first identified in March.”A third farmworker in the United States has been found to be infected with bird flu, heightening concerns about an outbreak among dairy cattle first identified in March.
    • “The worker is the first in this outbreak to have respiratory symptoms, including a cough, sore throat and watery eyes, which generally increase the likelihood of transmission to other people, federal officials said on Thursday.
    • “The other two people had only severe eye infections, possibly because of exposure to contaminated milk.
    • “All three individuals had direct exposure to dairy cows, and so far none has spread the virus to other people, Dr. Nirav Shah, principal deputy director of the Centers for Disease Control and Prevention, said at a news briefing.”
  • The National Institutes of Health announced,
    • “Using a combination of cutting-edge immunologic technologies, researchers have successfully stimulated animals’ immune systems to induce rare precursor B cells of a class of HIV broadly neutralizing antibodies (bNAbs). The findings, published today in Nature Immunology, are an encouraging, incremental step in developing a preventive HIV vaccine.”
  • The Institute for Clinical and Economic Review released,
    • “its revised Evidence Report assessing the comparative clinical effectiveness and value of ensifentrine (Verona Pharma) for the treatment of chronic obstructive pulmonary disease (COPD).”its revised Evidence Report assessing the comparative clinical effectiveness and value of ensifentrine (Verona Pharma) for the treatment of chronic obstructive pulmonary disease (COPD).
    • “COPD is a common cause of severe respiratory problems,” said ICER’s Chief Medical Officer, David Rind, MD. “People with COPD can experience persistent shortness of breath and fatigue that can significantly affect their daily activities. Current evidence shows that ensifentrine decreases exacerbations when used in combination with some current inhaled therapies and is well-tolerated by patients, but there are uncertainties about how much benefit it may add to unstudied combinations of inhaled treatments.” * * *
    • “Key Clinical Findings“Key Clinical Findings
      • “ICER does not have significant concerns about harms with ensifentrine. We have high certainty that ensifentrine added to maintenance therapy, compared with maintenance therapy alone, results in at least a small net health benefit, and may result in substantial net health benefit (“B+”). We have somewhat greater certainty in the benefits when ensifentrine is added to the regimens studied in the clinical trials than when added to optimized modern inhaler therapies for COPD.
    • “Key Cost-Effectiveness Findings
      • “Ensifentrine has not yet been approved by the FDA, and the manufacturer has not announced a US price if approved. ICER has calculated a health-benefit price benchmark (HBPB) for ensifentrine to be between $7,500 to $12,700 per year.”
  • The Centers for Medicare Services is contemplating moving coverage of PreExposure Prophylaxsis using Antiviral Therapy to prevent HIV infection from Medicare Part D to Medicare Part B.
  • The Wall Street Journal relates,
    • “Screens are inherently harmful to our sleep, right?
    • “It isn’t that black and white, some sleep experts now say.
    • “Spurred by recent research, sleep scientists and doctors are rethinking the conventional wisdom. In some cases, they are backing away from dogmatic approaches such as cutting out screens two hours before bedtime. And they are questioning how much the dreaded “blue light” actually delays sleep.
    • “It is becoming more evident that the tech in and of itself isn’t always the problem,” says Shelby Harris, a clinical psychologist specializing in behavioral sleep medicine in New York. “We need to figure out how to tailor the recommendations to the person.”
  • Mercer Consulting discusses “Help for opioid addiction: Some progress, much more to do.” 

From the U.S. healthcare business front,

  • Beckers Payer Issues shares the views of 32 payer executives about changes to healthcare delivery in the next ten years. For example,
    • Bruce Rogen, MD. Chief Medical Officer of Cleveland Clinic Employee Health Plan: Longitudinal patient records on each patient accessible by providers caring for the patient having a complete history of clinical data sourced from multiple EMRs and across payers and over time going back years if not decades.
    • AI platforms that are able to access the longitudinal patient record to engage the patient in preventive care, filling gaps in care, managing medication refills, enhancing medication compliance, and obtaining prior authorization from payers when indicated.
    • Teams of healthcare providers using the longitudinal patient record and the AI platforms to provide care anywhere and everywhere (hospital, post-acute, home care, remote, virtual) and focusing on prevention. The team includes physicians, nurses, navigators, care coordinators, pharmacists, social workers, behavioral health psychologists and counselors, community healthcare workers and home care workers.
    • Ilan Shapiro, MD. Chief Health Correspondent, Medical Affairs Officer and Senior Vice President at AltaMed (Los Angeles): In 10 years, healthcare delivery will likely be more patient-centric and value-based, with AI technology playing a crucial role in both treatment and prevention of illnesses. Patients will be incentivized for proactive wellness steps, fostering a culture of health promotion. Nationwide care coordination will be streamlined, reducing constraints and enhancing accessibility. This transformation will empower patients and healthcare teams, ensuring that care is brought back to the community level.
  • Per FierceHealthcare
    • “Well-being programs continue to be a central focus for employers, and they’re evolving the reach of these offerings into new areas such as the social determinants of health, according to a new survey.
    • “The Business Group on Health and Fidelity Investments released their annual look at employers’ strategies around wellness on Wednesday, and found nearly all of the 160 surveyed firms said they view well-being programs as a being key to their overall strategy. These employers said they intend to continue funding these programs at current levels.
    • “In addition, more than half (51%) said they plan to build out their well-being programs to tackle social needs in the next three to five years.”
  • The Wall Street Journal examines the connection between private equity investments and growing healthcare costs.
    • “Consolidation is as American as apple pie.
    • “When a business gets bigger, it forces mom-and-pop players out of the market, but it can boost profits and bring down costs, too. Think about the pros and cons of Walmart and “Every Day Low Prices.” In a complex, multitrillion-dollar system like America’s healthcare market, though, that principle has turned into a harmful arms race that has helped drive prices increasingly higher without improving care. 
    • “Years of dealmaking has led to sprawling hospital systems, vertically integrated health insurance companies, and highly concentrated private equity-owned practices resulting in diminished competition and even the closure of vital health facilities. As this three-part Heard on the Street series will show, the rich rewards and lax oversight ultimately create pain for both patients and the doctors who treat them. Belatedly, state and federal regulators and lawmakers are zeroing in on consolidation, creating uncertainty for the investors who have long profited from the healthcare merger boom.”
  • STAT News considers the lack of consensus over the meaning of value-based care. Sigh.
    • “Mai Pham, president of the Institute for Exceptional Care, said her benchmark for success is not how health care providers are feeling. It’s what is actually happening to the nation’s health, and the status quo in her view is unacceptable. Life expectancy among Americans has plateaued, and life expectancy for Americans in the prime years of their lives is falling. This trend, Pham noted, started before the Covid-19 pandemic, and it’s happening across races and geography.
    • “It’s difficult to say whether value-based care has been a success. Medicare has tried a broad range of programs and strategies, each of which has involved a broad range of organizations. Some have done well, others have not.
    • “So it’s not a binary answer,” Pham said. “What I would say is that it has not lived up to the hype.”
  • mHealth Intelligence tells us,
    • “Though telehealth use skyrocketed among United States adults with private health insurance during the COVID-19 pandemic, new research reveals that rural residents utilized telehealth less than their urban peers.
    • “The research, published by the AARP Public Policy Institute last week, examined changes in telehealth use from 2019 to 2021 among people younger than 65 enrolled in private, employer-sponsored health insurance plans.”

Midweek Update

David Ermer–CDC, Congress, COVID-19 vaccine, Generative AI, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • The New York Times reports,
    • “The chairmen of two Senate committees overseeing health policy, concerned about companies “padding their own profits” at the expense of patients, are looking into the practices of a data analytics firm that works with big insurers to cut payments to medical providers.
    • “The firm, MultiPlan, recommends what it says are fair payments for medical care, but the firm and the insurers can collect higher fees when payouts are lower. This business model could “result in an improper conflict of interest,” the chairmen of the two committees, Ron Wyden of Oregon and Bernie Sanders of Vermont, wrote in a letter to the firm’s chief executive that was released on Tuesday.
    • “The senators called on MultiPlan to meet with the committees’ staffs to discuss an investigation last month by The New York Times that found the firm’s pricing tools could leave patients with unexpectedly large bills when they see doctors outside their health plans’ networks.”
  • Govexec tells us,
    • “The Office of Personnel Management last week gave agencies a reminder that as campaign season approaches, officials should be vigilant against efforts to “burrow” political appointees into career positions in the federal government’s competitive and Senior Executive services.
    • “In a memo to agency heads, OPM’s associate director for merit system accountability and compliance Mark Lambert and associate director for workforce policy and innovation Veronica Hinton addressed the controversial practice, which is legal, albeit with a strict set of regulations to ensure political appointees are qualified for career roles they’re lined up for.”
  • KFF introduced,
    • “A new KFF resource—Health Policy 101—explains the basics on a wide range of topics about health programs and policy in the United States, such as Medicare and Medicaid, the Affordable Care Act, health care costs and affordability, women’s health issues, and the politics of health care. Health Policy 101 chapters are available online and can be downloaded in PDF format. The “101” was created to serve as a mini “textbook” for faculty and students interested in health policy. Dr. Drew Altman, KFF’s president and CEO, is the editor of the 101 series.”

From the public health and medical research front,

  • MedPage Today informs us,
    • “The updated monovalent XBB.1.5 COVID-19 vaccines were effective against Omicron subvariants circulating during the most recent respiratory virus season, but their effectiveness waned over time, according to a brief report.
    • “The three vaccines updated to target the SARS-CoV-2 XBB.1.5 subvariant — Moderna’s and Pfizer-BioNTech’s mRNA vaccines and the Novavax vaccine — were 66.8% effective against hospitalization at 4 weeks, decreasing to 57.1% after 10 weeks, wrote Dan-Yu Lin, PhD, of the UNC Gillings School of Global Public Health in Chapel Hill, North Carolina, and colleagues.
    • “Vaccine effectiveness against infection was about 52% after 4 weeks, decreasing to 33% after 10 weeks, and to 20% after 20 weeks, the New England Journal of Medicineopens in a new tab or window correspondence showed.
    • “We expected these vaccines to be effective, especially against hospitalization and death. We also expected the effectiveness to decline over time,” Lin told MedPage Today. “However, we didn’t know beforehand the levels of effectiveness or the duration of protection.”
  • The Wall Street Journal shares the view of readers who have used GLP-1 drugs.
    • “Hundreds of readers responded in the comments space and by email to Bradley Olson’s essay about his experience using a GLP-1 drug for weight loss. Readers shared stories about their own attempts to lose weight, journeys that often took place over the course of decades and included nonmedicinal strategies before the advent of GLP-1 drugs. Our readers made overwhelmingly positive comments about the medications, and in general found that the transformational impact of the GLP-1 drugs made such difficulties as getting prescriptions filled and side effects bearable. Some readers who have struggled to lose weight wrote that they found inspiration in Olson’s essay to consider trying a medical solution.” 
  • Per BioPharma Dive,
    • “A new kind of antidepressant eased symptoms and improved sleep among adults enrolled in a large Phase 3 trial, Johnson & Johnson, the drug’s developer, said Wednesday.
    • “J&J is studying the drug, called seltorexant, as an “adjunctive” therapy to background treatment with other antidepressants like SSRIs. The company’s trial enrolled adults with major depressive disorder as well as insomnia, which often accompanies depression and isn’t well treated by SSRIs.
    • “J&J didn’t disclose detailed data in its Wednesday statement. But the company did share the trial met all of its primary and secondary goals, noting the improvement in depressive symptoms among seltorexant-treated participants at study day 43 was both statistically significant and clinically meaningful.”
  • The New York Times dives into recent research on the sense of taste.
    • “The perception of taste is a remarkably complex process, starting from that first encounter with the tongue. Taste cells have a variety of sensors that signal the brain when they encounter nutrients or toxins. For some tastes, tiny pores in cell membranes let taste chemicals in.
    • “Such taste receptors aren’t limited to the tongue; they are also found in the gastrointestinal tract, liver, pancreas, fat cells, brain, muscle cells, thyroid and lungs. We don’t generally think of these organs as tasting anything, but they use the receptors to pick up the presence of various molecules and metabolize them, said Diego Bohórquez, a self-described gut-brain neuroscientist at Duke University. For example, when the gut notices sugar in food, it tells the brain to alert other organs to get ready for digestion.”
  • Healio lets us know,
    • “Women who get an epidural during delivery appear to have a marked reduction in serious complications the first few weeks after giving birth, a new study shows.
    • “A painkilling epidural can reduce risk by 35% in women for complications like heart attack, heart failure, blood infection and hysterectomy that can occur as a result of delivery, researchers reported May 22 in the BMJ.
    • “And the risk declines even more for women with known risk factors for these complications such as obesity, other health problems or prior delivery, researchers said.
    • “For those women, an epidural can reduce their risk of complications by 50%, compared to a 33% risk reduction in those without such factors.
    • “And women delivering preterm had a risk reduction of 47%, results show.”
  • and
    • “Researchers found that a questionnaire successfully identified patients with STIs who can be safely evaluated for penicillin allergy by skin test or by a two-step graded oral challenge, according to a study.
    • “Providers caring for clients with STIs are often faced with clients reporting a history of penicillin allergy (up to 15% of clients). Penicillin remains the drug of choice for the treatment of all stages of syphilis,” Rebecca A. Lillis, MD, associate professor at the Louisiana State University School of Medicine, told Healio.
    • “Ceftriaxone is the drug of choice for treatment of gonorrhea and often avoided in clients who report a penicillin allergy, resulting in suboptimal care,” she said.”
  • The National Institutes of Health announced,
    • “A team of researchers funded by the National Institutes of Health have generated the first complete chromosome sequences from non-human primates. Published in Nature(link is external), these sequences uncover remarkable variation between the Y chromosomes of different species, showing rapid evolution, in addition to revealing previously unstudied regions of great ape genomes. Since these primate species are the closest living relatives to humans, the new sequences can provide insights into human evolution.”

From the U.S. Healthcare business front,

  • Per Fierce Healthcare,
    • “A significant gap exists between health plans that have the highest consumer experience scores and those with the lowest, according to a new survey from J.D. Power.
    • “The consumer insights firm released its annual look at commercial health plans and found that overall satisfaction lands at a score of 595 out of 1,000 points, an increase of three points from 2023’s survey. However, the analysts found a 79-point gap between plans with the highest and lowest scores.
    • “Further, plans with the best consumer satisfaction ratings are getting better, while the lowest-performing plans are sliding. Scores at the highest performers increased by 20 points, while lower scores declined by eight points.
    • “In many cases, employer-sponsored health insurance is consumers’ primary window into the healthcare system,” said Christopher Lis, Ph.D., managing director of global healthcare intelligence at J.D. Power, in a press release. “Access to care, cost of care, chronic condition management—the central pillars of the consumer healthcare experience—are all heavily influenced by commercial health plans.”
  • and
    • “The proportion of hospitals meeting the Office of the National Coordinator for Health IT’s (ONC’s) bar for interoperability rose substantially from 2018 to 2023, though a focus on day-to-date data exchange will be necessary to fill some remaining gaps.
    • “According to a recent data brief from ONC, 7 in 10 nonfederal acute care hospitals reported either “routinely” or “sometimes” engaging in all four measured domains of electronic health information interoperability: sending data (92%), receiving data (87%), querying data from outside their organization (84%) and integrating outside data into their records without manual entry (78%).
    • “The 70% top line is an improvement from the 23% of 2014 and the 46% of 2018. Interoperability remained flat at 70% from 2022 to 2023, though the ONC noted that its surveys for the two years were fielded nearly back-to-back to catch up following pandemic polling delays.”
  • Beckers Payer Issues points out,
    • “UnitedHealth Group is running around 500 use-case applications for AI across the organization, CEO Andrew Witty told investors. 
    • “Speaking at a conference on May 29, Mr. Witty said some of the company’s AI efforts are “low-hanging” opportunities aimed at speeding up administrative processes. 
    • “It’s not Einstein opportunities,” he said. “These are relatively straightforward. Some of them are already underway. They play out in areas like speed, allowing call handlers to deal with issues faster than they used to.” 
    • “Heather Cianfrocco, CEO of Optum, told investors Optum’s AI efforts are focused in two areas. 
    • “One is administrative support, particularly for clinicians, giving clinicians time back at home or in the office,” Ms. Cianfrocco said. “The second area I would highlight is identifying disease progression, or emerging disease, faster.” 

 

Tuesday Tidbits

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Happy Memorial Day!

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

From Washington, DC —

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday Factoids

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

Photo by Sincerely Media on Unsplash

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Miscellany

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Update

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

From Washington DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday Tidbits

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

From Washington, DC

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

From the public health and medical research front,

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

Monday Roundup

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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