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in 340B Health News Releases

WASHINGTON, D.C.— In a significant legal development, a federal court has issued a decision stating that the Health Resources & Services Administration (HRSA) exceeded its authority when it imposed certain conditions on covered entities (CEs) regarding their use of 340B drugs. The court states that while the statute requires a CE to have an ongoing relationship with a patient in order to use 340B, HRSA cannot further limit the use of 340B only to those drugs that pertain to care that the CE initiated. The court’s decision has far-reaching implications.

The following statement is attributed to Maureen Testoni, president and CEO of 340B Health:

“The court has sent a clear message that HRSA has not been transparent or consistent in its interpretation of 340B. While the decision affirms that the agency has the authority to issue and act on guidelines based on their interpretations of federal law, it also makes clear that HRSA must be consistent when enforcing its interpretations. Here, the judge found that HRSA was enforcing language that was not included in any of its published final interpretations, causing the court to enjoin HRSA enforcement in this case.” 

“The court underscores the importance of the government adhering to the plain and ordinary meaning of ‘patient’ as well as the broader application of 340B to assist safety-net providers amid high prescription drug prices, both as Congress intended.” 

“This ruling emphasizes the requirement that government agencies be transparent with their interpretations and enforcement policies.”

Contact: Jon Tilton at jon.tilton@340bhealth.org or 202-536-2285