The issue of who can be included under the definition of “patient” for purposes of dispensing 340B drugs is a critical one for many covered entities enrolled in the 40B Drug Discount Program, particularly disproportional share hospitals (DSHs). Four years after publishing proposed guidance on the definition of “patient” in January 2007, the Health Resources and Services Administration HRSA), the agency tasked with administering the popular, and often controversial, 340B Drug Discount Program, has now forwarded new guidance to the Office of Management and Budget for approval. The content of the new guidance is not yet known and any covered entities are anxious to learn whether the new guidance will expand he definition of patient in a manner that will permit them to provide more discounted drugs to the indigent and under insured population that they service.