Tuesday Tidbits

David Ermer–Congress, FDA, NIH, No Surprises Act, Rx coverage, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Roll Call provides this wrap up.
    • “With no prospect for a border security deal in sight, the Senate was preparing to leave town for the holidays and punt an emergency war funding package into the new year.
    • “Majority Leader Charles E. Schumer, D-N.Y., acknowledged Tuesday that reaching a bipartisan deal on policies to stem the flow of migrants at the southern border would not come together in time for a vote this week. 
    • “While we’ve made important progress over the past week on border security, everyone understands that we have more work to do and it’s going to take more time,” Schumer said on the floor.”
  • The Census Bureau reports, “Births in 2023 once again began to outpace deaths in over half of U.S. states as mortality declined, inching closer to pre-pandemic levels, according to U.S. Census Bureau population estimates released today.”
  • The Food and Drug Administration tells us,
    • “Today, the FDA approved the first test that uses DNA in assessing whether certain individuals may have an elevated risk of developing opioid use disorder. As part of a clinical evaluation, the AutoGenomics Inc. AvertD test is intended to be used prior to first exposure to oral opioid pain medications in patients being considered for a 4-30 day prescription for the treatment of acute pain, such as in patients scheduled to undergo a planned surgical procedure. The AvertD test, a prescription-use only genetic laboratory test for patients 18 years and older, is to be used only with patients who consent to the test and have no prior use of oral opioid analgesics.
    • “Today, the FDA refreshed the Know Your Treatment Options for COVID-19 Consumer Update and reminded consumers that they have several treatment options to prevent hospitalization and other serious complications of COVID-19. The FDA has approved drug treatments for COVID-19 and has authorized others for emergency use. In addition, more therapies are being tested in clinical trials to evaluate whether they are safe and effective in treating COVID-19.” 
  • HHS’s Agency for Healthcare Research and Quality has issued its 2023 National Healthcare Quality and Disparities report.
  • The International Foundation of Employee Benefits Plans tells us,
    • “The Internal Revenue Service (IRS) released Notice 2024-01 providing the percentage increase for calculating the qualifying payment amounts (QPAs) for items and services furnished in 2024 under sections 9816 and 9817 of the Internal Revenue Code. These provisions, added by the No Surprises Act, provide protections against surprise medical bills in certain circumstances. The QPA calculation is required in the case of a plan or issuer that does not have sufficient information to calculate the median of the contracted rates for the same or similar item or service provided in a geographic region. 
    • “For such an item or service furnished in a subsequent year (before the first sufficient information year for the item or service with respect to such plan or coverage or before the first year for which an eligible database has sufficient information to calculate a rate under 29 CFR 2590.716-6(c)(3)(i), and 45 CFR 149.140(c)(3)(i) in the immediately preceding year), the plan or issuer must calculate the QPA by increasing the QPA amount determined for the item or service for the year immediately preceding the subsequent year, by the percentage increase in the U.S. city average consumer price index (CPI-U) over the preceding year.
    • “The percentage increase in the CPI-U for items and services provided in 2024 over the preceding year is the average CPI-U for 2023 over the average CPI-U for 2022. Pursuant to this calculation, the percentage increase from 2023 to 2024 is 1.0543149339. Plans and issuers may round any resulting QPAs to the nearest dollar.”
  • The American Hospital Association News informs us,
    • “The Department of Labor Dec. 19 [proposed to] rescind a 2018 final rule which modified the definition of “employer” under federal law such that more individuals, including sole proprietors, were eligible to participate in association health plans based on geography or industry. That provision was previously vacated by a federal judge in 2019 and was appealed by the Trump Administration. In 2021, a stay was requested by the Biden Administration while it worked on a proposed rule to rescind the 2018 final rule.” 
  • The New York Times offers an overview of the approaches the Congress is considering to ease prescription drug shortages.

From the public health and medical research front,

  • JAMA provides the following key points from a recent study,
    • “Question  What is the impact of dietary sodium intake on blood pressure in middle-aged to elderly individuals?
    • “Findings  In this prospectively allocated diet order crossover study of 213 individuals, 1 week of a low-sodium diet resulted in an average 8–mm Hg reduction in systolic blood pressure vs a high-sodium diet, with few adverse events. The low-sodium diet lowered systolic blood pressure in nearly 75% of individuals compared with the high-sodium diet.
    • “Meaning  In this trial, the blood pressure–lowering effect of dietary sodium reduction was comparable with a commonly used first-line antihypertensive medication.”
  • Newly installed NIH Director Monica Bertagnolli offers her first Director’s blog on the topic of “Turning Discoveries to Health for All.”
  • Axios reports, “The new highly effective class of anti-obesity drugs has often been talked about as an alternative to bariatric surgery — but medications like Wegovy are increasingly being paired with the procedure.”
    • “Between 20% and 35% of patients who receive the most commonly performed bariatric surgery gain back most of the weight or fail to hit a certain target for body mass index.
    • “Combining one of the GLP-1s with bariatric surgery or endoscopic bariatric therapy, which is a less invasive procedure, “provided significant weight loss” when compared with those procedures alone, according to a systemic review of 11 studies that was published in the Journal of the Endocrine Society this month.
    • “The drugs will revolutionize for sure the landscape of bariatric treatment,” Enrique Elli, a bariatric surgeon at the Mayo Clinic, told Axios. “As a surgeon, I welcome these drugs because I think that will make bariatric surgery even more effective.”
  • The Wall Street Journal points out, “Hemp Gummies Are Sending Hundreds of Kids to Hospitals. Surge of THC products, vapes has states struggling to regulate the booming market.”
    • “The market has boomed in recent years, especially since 2021. Estimates of its size vary, but research firm Whitney Economics approximates the hemp-derived cannabinoids market at $28 billion—about the same size as craft beer and legal marijuana. About 10% of that figure represents products containing cannabidiol, or CBD, which isn’t intoxicating. ***
    • “The FDA has warned that the intoxicating products are dangerous to children but has said it needs Congress to pass a new law that would allow it to regulate cannabis products generally.
    • “This is a serious public health issue, and a solution is urgently needed,” said Patrick Cournoyer, who helps lead the committee studying cannabis for the FDA.
    • “Federal lawmakers have asked cannabis experts and companies to weigh in on possible legislation. Many of those invested in the debate hope Congress will address the issue in the Farm Bill next year.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Federal antitrust agencies on Monday finalized stricter guidelines for mergers and acquisitions that could make it more difficult for healthcare deals to close.
    • “The guidelines lay out a framework that the Department of Justice and Federal Trade Commission use when reviewing proposed deals and that the courts can reference in overseeing challenges. However, the guidelines are not legally binding themselves.
    • “The final merger guidelines are not meaningfully different from draft guidelines the DOJ and FTC released in July, according to antitrust experts.”
  • KFF has posted a report captioned “Recent Trends in Medicaid Outpatient Prescription Drug Utilization and Spending.”
    • Key findings include:
      • Even though Medicaid enrollment reached historic levels during the continuous enrollment period, Medicaid prescription drug utilization remained below FY 2017 levels through FY 2022.
      • Net spending (spending after rebates) on Medicaid prescription drugs is estimated to have grown in recent years, increasing from $29.8 billion in FY 2017 to $43.8 billion in FY 2022, a 47% increase.
      • Despite lower utilization, Medicaid spending on prescription drugs has increased, and both states and the federal government continue to take action to combat rising costs.
    • These findings are noteworthy because, typically, Medicaid receives the lowest available prices for prescription drugs.