Month: November 2023

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The much-awaited decision in the Genesis Health Care patient definition case in federal district court in South Carolina provides 340B hospitals and federal grantees welcome re-affirmations of the importance of the vital safety-net care they provide as well as Congress’s intent to support that care through the 340B program. Although the court limited its decision solely to the Genesis health center, and its decision is potentially subject to appeal, the ruling provides a strong indication that future courts reviewing attempts by HRSA to enforce an overly-restrictive “patient definition” could similarly reject the agency’s restrictions.

Here are 3 things hospitals and grantees need to know regarding their 340B programs from the Genesis decision:

1. Hospitals and grantees should revisit their 340B prescription eligibility criteria.

For more than a quarter century, HRSA relied upon informal guidance to interpret the otherwise undefined term “patient” in the 340B statute to restrict prescriptions 340B hospitals and