Federal Court Overturns Restrictive Interpretation of 340B Patient Definition, Confirms HRSA Authority to Define Patient

A federal court in South Carolina issued the first federal court decision related to the definition of a patient to whom a covered entity may provide 340B-discounted drugs.  In Genesis Health Care, Inc. v. Becerra, the court concluded that HRSA’s enforcement action finding diversion where the covered entity did not initiate the healthcare service resulting in the script filled with 340B discounted drugs was contrary to the 340B statute and statutory intent. In doing so, however, the court found that “HRSA does possess authority to implement its interpretations of the statutory term ‘patient’ through its authority to implement the dispute resolution process related to diversion.