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.