On December 14, 2023, Health Resources & Services Administration (HRSA) announced a new resource on the 340B Program website compiling resources associated with the 340B Program definition of “patient.” The website is available here. While the HRSA website compiling patient definition resources is new, none of the content is new. The website only provides links to existing HRSA and Apexus materials. The website makes clear that HRSA’s position is that it continues to rely on its 1996 guidance in interpreting the 340B Statute’s use of the term “patient.”
The timing of this new resource page in connection with last month’s decision in the Genesis case is likely not coincidental, as many 340B covered entities and other 340B Program stakeholders have been closely evaluating the 340B Program definition of “patient” following that decision. More information on the Genesis case is available in our analysis article here.
The release of this website could be an indication that HRSA intends to more closely review compliance with the 1996 definition of patient during audits of covered entities, although HRSA told the Government Accountability Office in 2020 that it did not have authority to issue audit findings of non-compliance based solely on guidance and acknowledged that the 340B statute does not provide criteria for determining patient eligibility.
Like the Genesis decision, the release of this new webpage provides another reminder for covered entities and other 340B Program stakeholders to revisit the concept of “patient” in the context of the 340B Program and 340B Statute to determine how best to define the term for purposes of their 340B-related operations.