Monday Roundup

David Ermer–ACA, CDC, FDA, Medical / Rx research, Mental health care, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • MedTech Dive reports
    • “The Food and Drug Administration released a final rule on Mondaystrengthening its authority over laboratory developed tests (LDTs), advancing a policy that has drawn fierce opposition from healthcare industry groups.
    • “The rule amends agency regulations to make explicit that in vitro diagnostics are devices under the Federal Food, Drug and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.
    • “The FDA said it will phase out its enforcement discretion approach for LDTs so that in vitro diagnostics manufactured by a laboratory will generally fall under the same enforcement policy as other tests.”
  • HHS’s Office for Civil Rights issued frequently asked questions about the final ACA Section 1557 rule issued on Friday.
  • Bloomberg lets us know,
    • “The US Department of Labor has rescinded a Trump-era rule that made it easier for small businesses and self-employed people to use cheaper association health plans that don’t comply with all the requirements of the Affordable Care Act. 
    • “The final Biden rule (RIN:1210-AC16) on association health plans was issued by the DOL’s Employee Benefits Security Administration Monday after clearing White House review, and will take effect 60 days after its April 30 publication in the Federal Register.”
  • HHS announced,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), announced $105 million in funding to support more than 100 community-based organizations working to improve maternal and infant health. HRSA Administrator Carole Johnson highlighted the news during a visit to Southside Medical Center, a new Healthy Start awardee, in Atlanta, Georgia. Georgia is the second stop on HRSA’s national Enhancing Maternal Health Initiative tour. Today’s Healthy Start funding announcement will support the health care and social needs of moms and babies in high need communities to help improve community health and tackle the unacceptable disparities in maternal and infant health outcomes. * * *
    • “For the full list of award recipients, visit the Healthy Start awards page.”

From the public health and medical research front,

  • The Washington Post reports,
    • “After decreasing for 27 years, the number of U.S. residents with tuberculosis has increased every year since 2020, with 9,615 cases recorded last year in the 50 states and D.C., according to a report from the Centers for Disease Control and Prevention.”After decreasing for 27 years, the number of U.S. residents with tuberculosis has increased every year since 2020, with 9,615 cases recorded last year in the 50 states and D.C., according to a report from the Centers for Disease Control and Prevention.
    • “The finding was based on data from the agency’s National Tuberculosis Surveillance System, which collects information from state and local health departments.
    • Caused by bacteria, tuberculosis usually attacks the lungs and spreads easily from person to person through the air. People who have the disease can spread the bacteria when they cough, sneeze or simply talk. * * *
    • “The latest numbers reflect a 16 percent increase in U.S. tuberculosis cases from 2022 to 2023, and the highest number of TB cases in the country since 2013, the CDC report says. The tally also reflects increases in all age groups and among people born in the United States as well as those born elsewhere, although the report found a larger increase among people born outside the United States vs. U.S.-born individuals (18 percent vs. 9 percent).
    • “Despite the recent increases, the CDC report describes the incidence of TB in the United States as “among the lowest in the world.”
  • The New York Times tells us,
    • “Physical fitness among children and adolescents may protect against developing depressive symptoms, anxiety and attention deficit hyperactivity disorder, according to a study published on Monday in JAMA Pediatrics.
    • “The study also found that better performance in cardiovascular activities, strength and muscular endurance were each associated with greater protection against such mental health conditions. The researchers deemed this linkage “dose-dependent”, suggesting that a child or adolescent who is more fit may be accordingly less likely to experience the onset of a mental health disorder.”
  • The CDC updated its online guidance about action to fight antimicrobial resistance.
    • Antimicrobial resistance happens when germs like bacteria and fungi develop the ability to defeat the drugs designed to kill them. That means the germs are not killed and continue to grow. Antimicrobial resistance has been found in every U.S. state and country. Addressing this threat requires continued aggressive action to:
      • Prevent infections in the first place
      • Improve antibiotic and antifungal use to slow the development of resistance
      • Stop the spread of resistance when it does develop
    • We all have a role to play, from travelers, animal owners, and care givers to patients and healthcare providers. Find out how you can help.

From the U.S. healthcare business front,

  • Fierce Healthcare relates,
    • “Inpatient volume growth across HCA Healthcare’s entire hospital portfolio and other steady gains on payer mix, length of stay and operating expenses have set the large chain on a strong trajectory for 2024, executives told investors Friday.
    • “The 188-hospital for-profit reported first-quarter net income of $1.59 billion ($5.93 per diluted share) and $17.34 billion in revenues.
    • “Those numbers are up from the $1.36 billion ($4.85 per diluted share) and $15.59 billion of the same period last year, and squarely ahead of consensus estimates of $5.09 earnings per share and $16.82 billion in revenues.”
  • and
    • “Teladoc acting CEO Mala Murthy sought to assure investors Thursday that the virtual care giant is poised for future growth even as it faces pressure in a saturated telehealth market.
    • “Following the abrupt departure of longtime CEO Jason Gorevic earlier this month, Teladoc is focused on boosting its top- and bottom-line performance as its shares have come under pressure, down more than 40% year-to-date.
    • “Teladoc is in a time of transition. And, as part of this evolution, the board of directors decided that it was time to look for a new leader for our company, someone to help us write the next chapter in our growth story,” Murthy, also Teladoc’s chief financial officer, said during the company’s first-quarter earnings call Thursday.”
  • Per Beckers Hospital Review,
    • “Increased reliance on imaging for diagnosis and efficient patient care mixed with higher volumes of patients has left hospitals scrambling to meet demand with the few radiologists they have.
    • “There are over 1,400 vacant radiologist positions posted on the American College of Radiology’s job board, according to a bulletin posted on its website. The total number of active radiology and diagnostic radiology physicians has dropped by 1% between 2007 and 2021, but the number of people in the U.S. per active physician in radiology grew nearly 10%, according to the Association of American Medical Colleges. An increase in the Medicare population and a declining number of people with health insurance adds to the problem.”
  • and
    • Demand for Type 2 diabetes drug Ozempic is high across the U.S., but interest varies by state, according to research conducted by Bison Pharmacy. 
    • Bison Pharmacy, a Canadian-based prescription referral service, analyzed monthly volume data on Google searches for “Ozempic” and “Ozempic price” in each state. 
    • New York is at the top of the list and Mississippi is on the bottom.