Midweek Update

OPM

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.

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.”

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.”

Thursday Miscellany

David Ermer–Congress, COVID-19 vaccine, Federal employment benefits, HSA, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “The House overwhelmingly voted to table Rep. Marjorie Taylor Greene’s attempt to oust Speaker Mike Johnson on Wednesday night, with nearly all Republicans and most Democrats coming to Johnson’s rescue.
    • “The final tally was 359-43, with 11 Republicans and 32 Democrats voting against the motion to table Greene’s resolution. Seven Democrats voted “present.”
  • The Society for Human Resource Management tells us,
    • “The annual limit on HSA contributions for self-only coverage in 2025 will be $4,300, a 3.6 percent increase from the $4,150 limit in 2024, the IRS announced May 9. For family coverage, the HSA contribution limit will jump to $8,550, up 3 percent from $8,300 in 2024.
    • “The jump in the contribution limits is significantly less than the roughly 7 percent increase seen from 2023 to 2024.
    • “The IRS did not yet release the 2025 catch-up contribution for savers age 55 and older. It currently stands at $1,000 for 2024, unchanged from 2023.
    • “Meanwhile, for 2025, a high-deductible health plan (HDHP) must have a deductible of at least $1,650 for self-only coverage, up from $1,600 in 2024, or $3,300 for family coverage, up from $3,200, the IRS noted. Annual out-of-pocket expense maximums (deductibles, co-payments and other amounts, but not premiums) cannot exceed $8,300 for self-only coverage in 2025, up from $8,050 in 2024, or $16,600 for family coverage, up from $16,100.
    • “The IRS also announced that the excepted-benefit HRA limit will be $2,150 in 2025, up from $2,100.”
  • Here’s a link to the IRS announcement.
  • Fierce Healthcare points out,
    • “The U.S. Department of Justice announced Thursday it has established a new task force to take on healthcare monopolies and collusion.
    • “The task force, called HCMC for short, will guide the division’s enforcement strategy and policy approach in healthcare, including by facilitating policy advocacy, investigations and, where warranted, civil and criminal enforcement in healthcare markets, the agency said in a press release.”
  • Govexec lets us know,
    • “The Office of Personnel Management continued to make gains in its backlog of federal employees’ pending retirement applications, though progress has begun to slow.
    • “The federal government’s dedicated HR agency processed 7,647 claims in April. That marks a sharp decrease from the 10,711 claims handled in March but remains above the 6,901 new claims OPM received last month.
    • “Overall, the backlog of pending claims ticked down to 16,077 by the end of April, a decrease of roughly 750 from March’s backlog of 16,823. The federal government’s retirement backlog has fallen 23% since January, but remains short of OPM’s “steady state” goal of 13,000 pending claims.”
  • Fedweek explains the circumstances under which an FEHB enrollee can make coverage changes outside of Open Season. Meanwhile, Reg Jones wraps up his series on FEGLI coverage.

From the public health and medical research front,

  • “U.S. Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a white paper detailing proposals to improve the National Institutes of Health (NIH). Last year, Cassidy requested feedback from stakeholders on policies Congress could consider to modernize NIH.  * * * Read the full white paper here.  
  • The NIH Director in her blog lets us know,
    • “Precision oncology, in which doctors choose cancer treatment options based on the underlying molecular or genetic signature of individual tumors, has come a long way. The Food and Drug Administration has approved a growing number of tests that look for specific genetic changes that drive cancer growth to match patients to targeted treatments. The NCI-MATCH trial, supported by the National Cancer Institute, in which participants with advanced or rare cancer had their tumors sequenced in search of genetic changes that matched them to a treatment, has also suggested benefits for guiding treatment through genetic sequencing. But there remains a need to better predict treatment responses for people with cancer.
    • “A promising approach is to analyze a tumor’s RNA in addition to its DNA. The idea is to not only better understand underlying genetic changes, but also learn how those changes impact gene activity as measured by RNA sequencing data. A recent study introduces an artificial intelligence (AI)-driven tool, dubbed PERCEPTION (PERsonalized single-Cell Expression-based Planning for Treatments In ONcology), developed by an NIH-led team to do just this.1 This proof-of-concept study, published in Nature Cancer, shows that it’s possible to fine-tune predictions of a patient’s treatment responses from bulk RNA data by zeroing in on what’s happening inside single cells.”
  • NIH announced,
    • “Starting people with opioid use disorder on extended-release, injectable naltrexone (XR-naltrexone) within five to seven days of seeking treatment is more effective than the standard treatment method of starting within 10-15 days, but requires closer medical supervision, according to results from a clinical trial(link is external) supported by the National Institutes of Health’s (NIH) National Institute on Drug Abuse (NIDA). Published in JAMA Network Open, the findings suggest that this rapid treatment protocol could make XR-naltrexone more viable as a treatment option for opioid use disorder, which continues to take lives at an alarming rate.
    • “When someone is ready to seek treatment for opioid use disorder, it is crucial that they receive it as quickly as possible,” said Nora Volkow, M.D., NIDA director. “This study paves the way for more timely care with one of the three medications for opioid use disorder we have available, better supporting people in their ability to choose the treatment option that will work best for them.”
  • The U.S. Preventive Health Task Force made available for public comment a draft research plan about the “Early Introduction of Allergens to Prevent Food Allergies in Infants: Counseling.” The comment period ends on June 5, 2024.
  • The Institutes for Clinical and Economic Review
    • “released a Draft Evidence Report assessing the comparative clinical effectiveness and value of imetelstat (Geron Corporation) for the treatment of anemia in myelodysplastic syndrome (MDS).
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.”
    • The comment deadline is June 10, 2024.
  • The Wall Street Journal explores the quest for treatments to keep weight off after taking blockbuster drugs such as Ozempic and Wegovy. Reading the article makes the FEHBlog think that that the drug manufacturers put the cart before the horse.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Some 23% of what patients owe is collected by hospitals before treatment, according to an analysis of first-quarter data this year from 1,850 hospitals by Kodiak Solutions, a healthcare consulting and software company. For the same period in 2022, the figure was 20%.
    • “They are seeking advance payment for nonemergencies, they say, because chasing unpaid bills is challenging and costly. Roughly half the debt hospitals wrote off last year was owed by patients with insurance, the Kodiak analysis found.
    • “We need those patients who are able to pay to do so,” said Leslie Taylor, a spokeswoman for University of Arkansas for Medical Sciences, which owns one general hospital in Arkansas and will—after discussing with doctors—reschedule some procedures until patients can pay.
    • “For patients, the hospitals say, knowing the cost ahead of service gives them the opportunity to comparison-shop and avoid getting walloped with a huge bill unexpectedly. * * *
    • “Still, finding money for treatment is a challenge for many American households. Half of adults say they can’t afford to spend more than $500 on medical care should they be suddenly sick or injured, a survey by health policy nonprofit KFF found. They would need to borrow. 
    • “In addition, determining how much a patient will owe can be tricky. How much each patient pays depends on their health plan, its deductible or other out-of-pocket costs and the prices the plan negotiated with a hospital to pay.” 
  • Fierce Healthcare relates that doctors are trying to add a CPT code for prior authorization which would give them health plan reimbursement for this administrative services.
  • MedTech Dive alerts us that “Surgical robots are ‘gift that will keep on giving,’ ortho firms say. Stryker, Zimmer and Globus reported double-digit sales growth in their robot segments and outlined plans for new products.”
    • “Orthopedics companies posted record robot sales in the first quarter, even as they plan new product launches in the second half of 2024.
    • “Stryker reported record installations of its Mako surgical robot in the first quarter, although it didn’t share an exact number. Jason Beach, Stryker’s vice president of finance and investor relations, said the company has seen “really good results” from direct-to-consumer ads promoting the surgical robot to people who might consider a hip or knee replacement.” 
  • Per BioPharma Dive,
    • “AstraZeneca will no longer manufacture or supply its COVID-19 vaccine Vaxzevria, announcing Tuesday it is voluntarily withdrawing the shot due to a “decline in demand,” a spokesperson wrote in an email to BioPharma Dive. 
    • “Prior to the announcement, the company had already taken steps to pull Vaxzevria from the market in Europe. It submitted a withdrawal request there in March which took effect on May 7. 
    • “The decision to withdraw the vaccine comes just after the company reported plummeting yearly sales for Vaxzevria, and reportedly admitted in court documents that the shot can cause a rare side effect that leads to a combination of blood clots and low platelet levels. AstraZeneca didn’t mention safety concerns as a reason for the vaccine’s withdrawal, however.”  

Monday Roundup

David Ermer–CDC, CMS, Medical / Rx research, Medicare, Mental health care, NIH, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Govexec reports
    • “Weeks following the news that Office of Personnel Management Director Kiran Ahuja would step down, agency Deputy Director Rob Shriver has been appointed acting director of the federal government’s dedicated HR agency.
    • “Shriver announced the news in a post on LinkedIn. * * *
    • “According to the Vacancies Act, Shriver may serve as acting OPM director for 210 days, or until Dec. 2. If he is ultimately nominated to succeed Ahuja on a permanent basis, he likely will be able to remain in the acting director role during the Senate confirmation process, thanks to his service as her “first assistant” in a Senate-confirmed position.”
  • Federal News Network tells us,
    • “Highlighting the work federal employees and other civil servants perform, and especially noting their efforts in administrating pandemic recovery programs, President Joe Biden expressed his appreciation for public servants across the country. In keeping with tradition, the White House issued a proclamation that May 5 will mark the beginning of Public Service Recognition Week.
    • “PSRW is traditionally celebrated the first full week of May. Many federally-focused organizations, including the National Active and Retired Federal Employees Association, show appreciation for public servants during the month of May.”
  • Govexec adds,
    • “Sammie Tafoya, a foreign service officer assigned to Haiti, said she didn’t know what the State Department was when her African history professor encouraged her to apply to work there. 
    • “Whenever I wrote for his class, he said…‘I think what you are looking for — the idea of being able to push change and to be able to write to inform the people that have power to make policies — there’s actually an agency for that. It’s the State Department. It’s the Foreign Service,’” she said. 
    • “Tafoya is one of 25 finalists announced Monday for the Partnership for Public Service’s 2024 Service to America Medals. Nicknamed the Sammies after the award’s namesake, Samuel J. Heyman, who founded the nonpartisan organization, the program has been around since 2002 and honors excellence and innovation in the career federal service. 
    • “The finalists will be recognized at a reception on Thursday, and winners will be announced ahead of an awards ceremony on Sept. 11 at the Kennedy Center.  * * *
    • “A full list can be found here.” 
  • The Society for Human Resource Management informs us,
    • “On May 3, President Joe Biden vetoed a resolution to overturn the National Labor Relations Board’s (NLRB’s) joint employer rule. However, the rule has been blocked by a federal district court in Texas, and litigation might continue.
    • “Overcoming the veto by a two-thirds majority vote in the Senate and House of Representatives is unlikely. The resolution passed the House by a 206-177 vote on Jan. 12 and cleared the Senate by a 50-48 vote on April 10. SHRM had urged Biden not to veto the measure.”

From the public health and medical research front,

  • The New York Time reports,
    • “Scientists are proposing a new way of understanding the genetics of Alzheimer’s that would mean that up to a fifth of patients would be considered to have a genetically caused form of the disease.
    • “Currently, the vast majority of Alzheimer’s cases do not have a clearly identified cause. The new designation, proposed in a studypublished Monday, could broaden the scope of efforts to develop treatments, including gene therapy, and affect the design of clinical trials.
    • “It could also mean that hundreds of thousands of people in the United States alone could, if they chose, receive a diagnosis of Alzheimer’s before developing any symptoms of cognitive decline, although there currently are no treatments for people at that stage.
    • “The new classification would make this type of Alzheimer’s one of the most common genetic disorders in the world, medical experts said.”
  • and
    • “A new study, published Saturday in The Journal of the American Medical Association, revealed growing disparities in child death rates across racial and ethnic groups. Black and Native American youths ages 1 to 19 died at significantly higher rates than white youths — predominantly from injuries such as car accidents, homicides and suicides.
    • “Dr. Coleen Cunningham, chair of pediatrics at the University of California, Irvine, and the pediatrician in chief at Children’s Hospital of Orange County, who was not involved in the study, said the detailed analysis of the disparities documented “a sad and growing American tragedy.”
    • “Almost all are preventable,” she said, “if we make it a priority.”
  • The Wall Street Journal discusses efforts in the U.S. to eliminate cervical cancer using the HPV vaccine.
    • “Doctors are rallying around an audacious goal: eliminating a cancer for the first time. 
    • “Cervical cancer rates in the U.S. have dropped by more than half since the 1970s. Pap tests enable doctors to purge precancerous cells, and a vaccine approved in 2006 has protected a generation of women against human papillomavirus, a sexually transmitted infection that causes more than 90% of cervical cancers. 
    • “With this evidence that the disease is preventable, groups that have worked for decades to end polio and malaria are turning to cervical cancer, plotting to take cases down to null. The World Health Organization is urging countries to boost vaccination, screening and treatment. Doctors in the U.S. are working on a national plan.” 
  • Beckers Hospital Review lets us know,
    • “A 12-year-old boy is the first commercial patient in the world to receive an FDA-approved gene therapy for sickle cell disease, The New York Times reported May 6.
    • “Kendric Cromer is a 12-year-old boy from the suburbs of Washington, D.C., and the first to receive Lyfgenia, a gene therapy treatment created by Somerville, Mass.-based Bluebird Bio. Kendric’s treatment, which costs about $3.1 million, is covered by his family’s insurance. He underwent the first part of treatment at Washington, D.C.-based Children’s National Hospital, in which physicians removed his bone marrow stem cells, which Bluebird will genetically modify for his treatment. The modified cells will be returned in three months.
    • “The FDA gave two companies authorization to sell gene therapy to people with sickle cell disease, a genetic disorder that affects roughly 100,000 people, most of them Black. 
    • “Bluebird estimates it can only treat 85 to 105 patients each year with sickle cell or beta thalassemia, who can receive a similar gene therapy. Children’s National, meanwhile, said it can accept only 10 gene therapy patients a year.”
  • The American Medical Association points out “What doctors wish patients knew about osteoporosis.”
  • The National Institute for Mental Health updated its website about coping with traumatic events.
  • The Washington Post notes, Ultrasound technology is used in many ways. Addiction is the next frontier. The use of the high-frequency sound waves is also being adapted to treat Alzheimer’s disease, tumors and psychiatric disorders.

From the U.S. healthcare business front,

  • Fierce Healthcare offers a look at how “major payers fared in a Q1 dragged by a cyberattack, MA challenges,” and Beckers Payer Issues ranks major payers by first quarter 2023 and 2024 medical loss ratios.
  • Beckers Payer Issues discusses major Medicare Advantage insurer plans for 2025.
  • Healthcare Dive reports,
    • “Dallas-based Steward Health Care, the largest physician-led hospital operator in the country, filed for Chapter 11 bankruptcy this morning in the U.S. Bankruptcy Court for the Southern District of Texas, following months of financial struggles including missed payments to its landlord and vendors.
    • “Steward operates more than 30 hospitals across eight states, according to a spokesperson for the company. The filing marks the largest provider bankruptcy in decades, according to Laura Coordes, professor of law at the Sandra Day O’Connor College of Law at Arizona State University.” 

Friday Factoids

David Ermer–CDC, CMS, Congress, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • A Senate Finance Committee tells us,
    • “U.S. Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and Chair Ron Wyden (D-Oregon) released a legislative proposal to address persistent economic problems leading to shortages of generic medicines plaguing America’s health care system, including chemotherapy drugs and ADHD medications. * * *
    • “The proposal, released as a discussion draft, would establish a new program in Medicare for hospitals and physicians to incentivize transparent, reliable, and resilient purchasing practices across supply-chain participants, including by driving health care providers, intermediaries (such as group purchasing organizations, or GPOs) and drug manufacturers to meet ambitious, proactive standards in securing a sustainable, high-quality supply of essential medicines for patients from all walks of life. * * *
    • “A one-page summary of the discussion draft can be found here.
    • “A section-by-section summary can be found here.
    • “The legislative text can be found here.”
  • STAT News reports,
    • “Members of Congress appear poised to advance another short-term [two year] extension of pandemic-era telehealth flexibilities instead of permanently addressing the issue, seven sources familiar with the talks said.
    • “During the Covid-19 pandemic, lawmakers allowed Medicare patients to access telehealth services in more places and with a greater variety of providers than before, but some of those flexibilities are set to expire at the end of the year. The expiration is expected to be an impetus for a broader health care package in December, when other public health programs also run out. * * *
    • “The House Ways & Means Committee is planning to mark up a two-year telehealth policy extension next week, per five sources familiar with the planning. Politico first reported the markup. According to two sources, the markup will contain entirely new language than is in the dozen or so bills that have been circulated so far.”
  • The U.S. Office of Personnel Management’s final Postal Service Health Benefits Program (PSHBP) implementation rule appeared in the Federal Register’s Public Inspection list today. The final rule will be published in the Federal Register on Monday May 6.
    • “OPM is making several changes between the interim final rule and this final rule:
      • “In § 890.1604, OPM is clarifying the requirements to enroll in Medicare Part B by expressly providing that the exceptions referring to events occurring “as ofJanuary 1, 2025” includes events that occur on January 1, 2025.”
      • In § 890.1604, OPM is clarifying the requirements to enroll in Medicare Part B by expressly providing that the exceptions referring to events occurring “as of January 1, 2025” includes events that occur on January 1, 2025.
      • “Section 890.1604(c) is reserved in anticipation of future rulemaking. [FEHBlog note — This provision creates exceptions from the Medicare Part B enrollment mandate for certain PSHBP enrollees and family members.]
      • “In § 890.1604(e), OPM is clarifying that a Postal Service annuitant or their family member who is required to be enrolled in Medicare Part B must promptly notify OPM or the Postal Service, in writing, if they choose not to enroll in or to disenroll from Medicare Part B.
      • “In § 890.1604, OPM is removing reference to the Postal Service as the entity to receive documentation of overseas residency to qualify for an exception to the Part B enrollment requirement.
      • “In § 890.1606(e), OPM is correcting a typographical error by removing the word “the” before “January 1 of the next year.”
  • A proposed follow-up PSHBP rule is pending review at OMB’s Office of Information and Regulatory Affairs. OPM further explains in the preamble.
    • “Topics OPM plans to address in more detail in the proposed rule include: reconsideration of initial decisions concerning PSHB eligibility; application of the Medicare Part B requirement and associated exceptions in specific scenarios; allocation of Reserves credits; calendar year alignment of government contribution requirements; financial reporting and actuarial calculations; premium payment prioritization from the Postal Service Retiree Health Benefits Fund; and Medicare Part D integration.” 
  • CMS also released a No Surprises Act user guide for resubmission of certain IDR cases.
    • “This user guide provides an overview of the “Notice of IDR Initiation – Resubmission” web form and the steps for successfully completing and submitting the web form. This user guide is intended to assist parties who have submitted a dispute through the Federal Independent Dispute Resolution (IDR) process and received an email from Auto-Reply-FederalIDRQuestions@cms.hhs.gov with a link to the “Notice of IDR Initiation – Resubmission” web form.
    • “The “Notice of IDR Initiation – Resubmission” web form will be sent to the initiating party if the certified IDR entity’s eligibility review of a dispute determines that one or more of the dispute line items must be resubmitted because it was improperly batched or bundled. The initiating party must complete the “Notice of IDR Initiation – Resubmission” web form by the deadline specified in the email. The non-initiating party will not need to take any action.”

From the public health and medical research front,

  • The Centers for Disease Control informs us on May 3:
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare continues to decrease across most areas of the country. This week, no jurisdictions experienced moderate, high, or very high activity. Last week one jurisdiction experienced moderate activity. No jurisdictions experienced high or very high activity.
    • “Nationally, emergency department visits with diagnosed influenza are decreasing. Emergency department visits with COVID-19 and RSV remain stable at low levels.
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week.
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, remains low.”
  • NBC News reports,
    • “New research suggests patients with an average risk of colon cancer may only need to undergo a colonoscopy screening every 15 years instead of the recommended 10. 
    • “Swedish researchers found that waiting an extra five years after a first negative colonoscopy carried about the same risk of later having a colorectal diagnosis or dying from the disease as getting screened every 10 years. Extending screening time could reduce “unnecessary invasive examinations,” according to the study published Thursday in JAMA Oncology.  * * *
    • “In an editorial accompanying the new study, gastroenterologists suggested that future screening guidelines may safely be prolonged for some people, noting that “15 has the potential to be the new 10.” * * *
    • “We do not have enough gastroenterology doctors to do a colonoscopy every 10 years in everyone over 50,” said Dr. Otis Brawley, the Bloomberg distinguished professor of oncology and epidemiology at Johns Hopkins University, who was not associated with the new research. * * *. 
    • “Employing cheaper, less invasive screening methods 10 to 15 years after a negative colonoscopy could greatly reduce the number of missed screenings, said the study’s lead author, Dr. Mahdi Fallah, head of the Risk Adapted Cancer Prevention Group at the German Cancer Research Center in Heidelberg. 
    • “The best screening test is the one that is actually done. So, if a test like colonoscopy is unaffordable for a person, an alternative cheaper valid test is much better than no test at all,” said Fallah, who is also a visiting professor in the department of clinical sciences at Lund University in Sweden.”
  • The Institute for Clinical and Economic Review announced on May 2,
    • “[We] will assess the comparative clinical effectiveness and value of tabelecleucel (“tab-cel”, Pierre Fabre) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).
    • “The assessment will be publicly discussed during a meeting of the New England CEPAC in November 2024, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.“

From the U.S. healthcare business front,

  • Kaufmann Hall announced on May 2,
    • “[Hospital m]argins and volumes declined slightly in March, which may signal more challenges ahead. Hospital outpatient revenue also fell 5%, reflecting the competitive challenges of providing outpatient care.
    • “The median Kaufman Hall Calendar Year-To-Date Operating Margin Index reflecting actual margins for the month of March was 3.9%.
    • “The April issue of the National Hospital Flash Report covers these and other key performance metrics.
  • and
    • “Overall labor expenses and revenue continue to rise, and Q1 2024 data show that labor represented 84% of total expenses. The median investment/subsidy per provider increased 2% compared to Q1 2023.
    • “The [Q1] Physician Flash Report features the most up-to-date industry trends drawn from the same data physician groups use to track their finances and operations.”
  • Beckers Hospital Review compares Spring 2024 Leapfrog Hospital Safety Grades against CMS Star ratings for hospitals receiving high and low Leapfrog grades.
  • BioPharma Dive notes,
    • “Amgen shares soared by double digits Friday following its announcement an obesity drug it’s developing has shown enough promise to warrant advancing into late-stage testing.
    • “On an earnings call with analysts Thursday, CEO Robert Bradway said the company is “confident” in the drug’s “differentiated profile” following an internal review of interim Phase 2 study results. Full data are expected by the end of the year and should support a subsequent move into Phase 3 trials, executives said.
    • “Yet Amgen’s drug is likely at least two years away from regulators’ desks, by which time Eli Lilly and Novo Nordisk may already have successors to their weight loss medicines Wegovy and Zepbound. It will take even more time to accumulate data to prove the drug can protect heart health, a key claim for convincing commercial and federal insurers to reimburse for treatment.”
  • Healthcare Dive lets us know,
    • “Walgreens has inked a clinical trial deal with major German drugmaker Boehringer Ingelheim.
    • “Under the deal, Walgreens will find candidates who are overweight or have obesity or diabetes and connect them with a Phase III clinical trial for Boehringer’s GLP-1 drug survodutide, according to a release.
    • “Walgreens launched its clinical trials business in 2022 as part of the company’s broader pivot to health services. Since then, Walgreens has notched more than 35 clinical trials deals with life sciences companies, according to a spokesperson.”

Midweek Update

David Ermer–Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, NIH, OPM, U.S. Healthcare, Uncategorized–
Photo by Mel on Unsplash

From Washington, DC,

  • Here’s a link to a the brief text of Senate bill 4811 that would allow over 100,000 reservists and National Guard members who also are federal employees to transfer from the FEHB to the lower cost Tricare Reserve Select healthcare program effective January 1, 2025.
  • Kevin Moss, writing in Govexec, points out the advantages of FEHB high deductible health plans.
  • Beckers Hospital Review alerts us,
    • “A Senate committee opened an investigation into Novo Nordisk’s list prices for Ozempic and Wegovy, Novo Nordisk’s diabetes and weight loss drugs. 
    • “In an April 24 letter to Novo Nordisk’s CEO, the Senate Committee on Health, Education, Labor, and Pensions said Ozempic and Wegovy are “exorbitantly expensive,” which restricts access to the drugs for millions of Americans. 
    • “In the U.S., a four-week supply of Ozempic costs $969, and Wegovy is $1,349. That’s up to 15 times more than what Novo Nordisk charges in Canada, Europe and Japan, the letter said. 
    • “In 2023, pharmacies, clinics and hospitals spent more than $38 billion on the two products, which contain the same drug, semaglutide. They were the No. 1 pharmaceutical expense for U.S. healthcare, according to research published April 24.”
  • STAT News confirms,
    • “Spending on GLP-1 drugs like Ozempic and Wegovy ballooned last year and they’re set to cost the U.S. health care system and the federal government still more this year and beyond, two new reports released Wednesday show.
    • “One study from the American Society of Health-System Pharmacists found that GLP-1 treatments were a main driver of the increase in overall drug spending by health entities such as pharmacies and hospitals last year. In particular, expenditures on Novo Nordisk’s semaglutide — sold as Ozempic for diabetes and Wegovy for obesity — doubled to $38.6 billion, making the drug the top-selling medicine in 2023.
    • “The other report, by health policy research organization KFF, looked at the impact of the recent approval of Wegovy to prevent cardiovascular complications. Medicare is barred from covering drugs for weight loss purposes, but the new approval means the federal payer can now cover Wegovy when prescribed to reduce heart risks. As a result, Medicare could spend $2.8 billion in a year on the single drug, the researchers conservatively estimate.
    • “Taken together, the reports provide a window into the pressure that GLP-1 drugs could place on overall health care spending going forward, especially as more people take the medications. The treatments have been in short supply, but drugmakers are ramping up manufacturing capacity to meet the unprecedented demand from patients. The pharma companies are also seeking approval for even more indications like heart failure and sleep apnea.”
  • The New York Times reports,
    • “The Food and Drug Administration on Wednesday approved the sale of an antibiotic for the treatment of urinary tract infections in women, giving U.S. health providers a powerful new tool to combat a common infection that is increasingly unresponsive to the existing suite of antimicrobial drugs.
    • “The drug, pivmecillinam, has been used in Europe for more than 40 years, where it is often a first-line therapy for women with uncomplicated U.T.I.’s, meaning the infection is confined to the bladder and has not reached the kidneys. The drug will be marketed in the U.S. as Pivya and will be made available by prescription to women 18 and older. * * *
    • “Utility Therapeutics, the U.S. company that acquired the rights to pivmecillinam, said it would be available in 2025. The company is also seeking F.D.A. approval for an intravenous version of the drug that is used for more serious infections and is usually administered in a hospital setting.
    • “Health practitioners said they were elated to have another tool in their arsenal given the growing challenge of antimicrobial resistance, which makes existing medications less effective as pathogens mutate in ways that allow them to survive a course of antibiotics.”
  • As we learned yesterday, “Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The regulatory decision for Ojemda covers a broader swath of patients than a drug combination from Novartis approved for treating this childhood cancer.” MedCity News adds,
    • “Ojemda is available as an immediate-release tablet or an oral suspension, both administered once weekly. Dosing of the Day One drug is according to body surface area, which is consistent with dosing for other pediatric medications, Blackman said. Day One has set a $33,816 wholesale price for a 28-day supply. That means the annual cost of the therapy will top $440,000. Ojemda’s price is the same for all packages of the drug and will not change as a child grows and needs higher doses, Chief Commercial Officer Lauren Merendino said.
    • “The two formulations of Ojemda can be taken at home, which minimizes disruption to the lives of patients and families, Merendino said. Day One’s goal is to establish Ojemda as the physician’s first choice of therapy for pLGG. Merendino said the drug should become available in about two weeks.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Dairy cows must be tested for bird flu before moving across state lines, under a federal order issued Wednesday, as evidence mounts that the virus is more widespread than feared among cows in the United States.
    • Biden administration officials said the move is meant to contain transmission of the virus known as H5N1 and to reduce the threat to livestock, but they maintained that the risk to humans remains low. * * *
    • “An order issued by the U.S. Agriculture Department that takes effect Monday requires every lactating dairy cow to be tested before moving across state lines. Cows carrying the virus would have to wait 30 days and test negative before being moved, officials said. Positive test results would trigger additional requirements for herd owners to disclose information, including the movement of animals, to aid epidemiologic investigations, and for laboratories and state veterinarians to report cases to the USDA.
    • “Requiring positive test reporting will help USDA better understand this disease and testing before interstate movement will limit the spread of the virus,” Mike Watson, administrator of the USDA’s Animal and Plant Health Inspection Service, told reporters.
    • “This is an evolving situation, and we are treating it seriously and with urgency,” he said.”
  • The International Foundation of Employee Benefit Plans discusses “What Health Plan Sponsors Should Know About the Emerging Mental Health Needs of Youth.”
  • The National Cancer Institute released its latest Cancer Information Highlights.
  • The National Institutes of Health announced,
    • “In a proof-of-concept study, researchers demonstrated the effectiveness of a potential new therapy for Timothy syndrome, an often life-threatening and rare genetic disorder that affects a wide range of bodily systems, leading to severe cardiac, neurological, and psychiatric symptoms as well as physical differences such as webbed fingers and toes. The treatment restored typical cellular function in 3D structures created from cells of people with Timothy syndrome, known as organoids, which can mimic the function of cells in the body. These results could serve as the foundation for new treatment approaches for the disorder. The study, supported by the National Institutes of Health (NIH), appears in the journal Nature.
    • “Not only do these findings offer a potential road map to treat Timothy syndrome, but research into this condition also offers broader insights into other rare genetic conditions and mental disorders,” said Joshua A. Gordon, M.D., Ph.D., director of the National Institute of Mental Health, part of NIH.”
  • A primary care expert writing in Medscape offers a commentary on the new Shield blood test available for colon cancer screening.
    • “We will need to be clear [to patients] that the blood test is not yet endorsed by the USPSTF or any major guideline group and is a second-line test that will miss most precancerous polyps. As with the stool tests, it is essential to emphasize that a positive result must be followed by diagnostic colonoscopy. To addend the cancer screening maxim I mentioned before, the blood test is not the best test for CRC, but it’s probably better than no test at all.”
  • Health IT Analytics tells us,
    • “Researchers from the University of Virginia (UVA) have developed a machine learning tool designed to assess and predict adverse outcome risks for patients with advanced heart failure with reduced ejection fraction (HFrEF), according to a recent study published in the American Heart Journal.
    • “The research team indicated that risk models for HFrEF exist, but few are capable of addressing the challenge of missing data or incorporating invasive hemodynamic data, limiting their ability to provide personalized risk assessments for heart failure patients.
    • “Heart failure is a progressive condition that affects not only quality of life but quantity as well,” explained Sula Mazimba, MD, an associate professor of medicine at UVA and cardiologist at UVA Health, in the news release. “All heart failure patients are not the same. Each patient is on a spectrum along the continuum of risk of suffering adverse outcomes. Identifying the degree of risk for each patient promises to help clinicians tailor therapies to improve outcomes.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Prices for surgery, intensive care and emergency-room visits rise after hospital mergers. The increases come out of your pay. 
    • “Hospitals have struck deals in recent years to form local and regional health systems that use their reach to bargain for higher prices from insurers. Employers have often passed the higher rates onto employees. 
    • “Such price increases added an average of $204 million to national health spending in the year after mergers of nearby hospitals, according to a study published Wednesday by American Economic Review: Insights. 
    • “Workers cover much of the bill, said Zack Cooper, an associate professor of economics at Yale University who helped conduct the study. Employers cut into wagesand trim jobs to offset rising insurance premiums, he said. “The harm from these mergers really falls squarely on Main Street,” Cooper said. 
    • “Premiums are rising at their fastest pace in more than a decade, driven up by persistently high inflation across the economy. Rising costs have fueled contentious negotiations that have led some hospitals and insurers to cancel contracts, leaving patients in the lurch. 
    • “Hospital mergers make the price pressures worse.” 
  • Per BioPharma Dive,
    • “Biogen has seen “encouraging early trends” in the launch of its postpartum depression pill Zurzuvae, revealing in first quarter earnings drug sales that surpassed the estimates of Wall Street analysts.
    • “Biogen said sales of Zurzuvae between January and March hit $12 million, up from $2 million in the fourth quarter of 2023 and doubling consensus estimates of $5 million to $6 million. The company didn’t, however, reveal the number of prescriptions filled for Zurzuvae, making demand for the drug difficult to track. 
    • “Zurzuvae, which was discovered by Biogen partner Sage Therapeutics and approved by the Food and Drug Administration last August, is the only pill available specifically meant to treat postpartum depression, or PPD. But its sales prospects are uncertain, as the condition often goes undiagnosed, and many who are diagnosed don’t receive treatment.”  
  • STAT News tells us,
    • “A year ago, when Novo Nordisk announced it would cut the price of multiple insulin products by up to 75%, President Biden, lawmakers, and patient groups all counted the move as a win.
    • But several months later, Novo decided to discontinue one of those products, the basal insulin Levemir.
    • “Though the insulin won’t officially be off the market until the end of this year, patients are already running into supply disruptions and insurance cutoffs, leaving them with few options. The discontinuation, which is happening only in the U.S., has now drawn alarm from some Democratic senators, who sent a letter to Novo last week demanding an explanation.
    • “The turn of events highlights a key gap in policy efforts: Even if officials can get drugmakers to cut prices, the companies can choose to just pull a drug off the market, without guaranteeing that other manufacturers will continue to make the compound.”
  • Beckers Payer Issues informs us,
    • “Humana reported $741 million in net income in the first quarter of 2024. 
    • “The company published its first quarter earnings report April 24, beating investor expectations. In Q1 2023, Humana posted $1.2 billion in net income.
    • “Total revenue in the first quarter was $29.6 billion, up 10.7% year over year. 
    • “Humana’s medical loss ratio was 88.9% in the first quarter, which the company projects will rise to about 90% for the full year.”
  • Beckers Hospital Review notes,
    • “Cleveland Clinic’s eHospital program has expanded and now monitors 248 patient beds in ICUs and other units across the organization’s network.
    • “The eHospital program launched in 2014 as a pilot in one intensive care unit. The program is centered around a component known as the “bunker,” an operations center on Cleveland Clinic’s main campus. The operations center is staffed from 7 p.m. to 7 a.m. daily by a team consisting of two critical care nurses and a physician. Their primary responsibility is to monitor patients across various ICU units within the Cleveland Clinic network.”
  • and identifies the 25 most expensive hospital drugs.
    • “Keytruda (pembrolizumab) was nonfederal hospitals’ costliest drug expense in 2023, according to research published April 24 in the American Journal of Health-System Pharmacy. 
    • “In 2021 and 2022, COVID-19 drug Veklury (remdesivir) was the No. 1 pharmaceutical expense for the nation’s hospitals. Most medicines on the list saw modest changes from the prior year except for TNKase (tenecteplase), a cardiovascular therapy that cost hospitals 87.9% more in 2023.” 

Tuesday Tidbits

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Weekend Update

David Ermer–Congress, OPM, U.S. Healthcare–

From Washington, DC,

  • The Government Accountability Office posted a report on public health preparedness.
    • “Health and Human Services was initially charged with coordinating the federal response to a 2022 global outbreak of mpox—a smallpox-related virus.
    • “State and local jurisdictions cited challenges in the federal response such as difficulty accessing and using vaccines and tests, which may have led to unnecessary suffering. We added HHS’s leadership and coordination of public health emergencies to our High Risk List earlier in 2022 due to similar issues in past responses.
    • “We recommended that HHS adopt a coordinated, department-wide program that incorporates input from external stakeholders to identify and resolve challenges.”
  • FedSmith offers its take on OPM’s benefit administration letter about tightening FEHB eligibility oversight.
    • “OPM will use its newly completed FEHB Master Enrollment Index (MEI) to run queries that can spot certain enrollment irregularities in existing enrollments. If any are found that raise questions, OPM will notify agencies to review those enrollments.”
    • In the FEHBlog’s view, the Master Enrollment Index will not be reliable until OPM starts using the HIPAA 820 electronic enrollment roster transaction which will allow carriers to reconcile individual enrollments with premiums received.

From the public health and medical research front,

  • The Washington Post reports on ongoing efforts to create a global pandemic preparedness accord.
    • “The United States has signaled its support for a legally binding agreement, including leveraging its purchasing power to expand access to medicines around the world. But the United States, like many European Union countries, is the object of mistrust because it is the seat of the powerful pharmaceutical industry, which is reluctant to relax control over manufacturing know-how.”
  • Fortune Well discusses how to keep your water bottle clean.
    • “Like many people, Carl Behnke regularly totes a water bottle around throughout his day. From the office to the gym and back home again, Behnke is rarely without it. But Behnke is also an associate professor in the school of hospitality and tourism management at Purdue University, and when he discovered a “biofilm” on the inside of his water bottle while cleaning it, it got his wheels turning. “I realized I probably wasn’t as diligent about cleaning my water bottle as I should be,” he explains. “And that made me curious: if someone who knows about food safety isn’t diligent, what about everyone else?”
    • “That question led to a study, conducted by Behnke and a cohort of academics and scientists into how reusable bottle contamination levels are affected by usage and cleaning behaviors. The group set about to measure contamination levels of water bottles, and to understand how those levels are affected by usage and cleaning behaviors. If you’re regularly drinking water from a reusable bottle, their findings might prompt you to reconsider your own water bottle handling practices.  * * *
    • “Dr. Yuriko Fukuta, assistant professor of medicine—infectious diseases at Baylor College of Medicine, agrees. “We’re constantly touching our water bottles with our mouths and hands, so it’s easy to transmit bacteria to them, and then it just grows,” she says “In some cases, this can make you sick, especially if you have a weaker immune system.” * * *
    • According to Fukuta, your best bets are bottles with a wide mouth, which make them easy to clean and dry, those with a built-in straw that keeps your hands away if possible.
    • If your goal is to keep your water bottle from turning into a germy breeding ground, the simplest approach is Behnke’s, which he changed after conducting the research. “I rinse my bottle once a day,” he says, “and wash it once a week, using good detergent, a bottle brush, and a spray of Clorox bleach.”