On April 15, President Trump signed an Executive Order reviving a previous directive to reduce the cost of insulin and injectable epinephrine for low income individuals. The Executive Order instructs the Secretary of U.S. Department of Health and Human Services (HHS) to require federally qualified health centers (FQHC) to offer 340B program pricing (plus a minimal administrative fee) for insulin and injectable epinephrine (i.e., Epi-Pens) to low-income patients who are uninsured or have high deductibles or cost-sharing.

Section 330 of the Public Health Service Act, under which HHS provides such grants, already contains extensive requirements regarding the provision of medical services to those unable to pay, including sliding fee 

The original Executive Order “triggered alarm among safety-net health care providers and bipartisan lawmakers because it would accomplish the opposite of what the Trump Administration intended — ultimately making it harder for health centers to provide affordable life-saving services and prescription drugs.” 

Health centers and Members of Congress observed that the original Executive Order and rule were “targeting the centers providing these medications to those without insurance or the means to get the care instead of big pharmaceutical companies,” while drug manufacturers had tripled their prices for insulin within the previous decade without any significant change in manufacturing costs. Tellingly, after Congress lifted the cap on the inflationary penalty for Medicaid drug rebates effective January 1, 2024, as part of the American Rescue Plan Act (ARPA), “insulin manufacturers … cut prices of some insulin products up to 80%.”

It is likely the revived Executive Order will spur a new round of notice-and-comment rulemaking. Community health centers and their allies should participate in the comment process and educate the new Administration’s health care team of the effects of the revived initiative.

For more information on the 340B program, please contact Steve Kuperberg at skuperberg@feldesman.com.