As the COVID-19 crisis continues to unfold, the Health Resources & Services Administration Office of Pharmacy Affairs (HRSA OPA) has taken unprecedented steps to provide 340B Program participants with additional flexibility to help meet surging patient demand. HRSA OPA acknowledges that this public health emergency may warrant additional flexibility, with respect to affected 340B covered entities.
More specifically, HRSA OPA has taken the following steps and provided the following guidance to assist 340B Program participants treating a surge in patients during this crisis: 1) Relaxing patient recordkeeping requirements necessary to determine patient eligibility; 2) Confirming that volunteer health professionals providing health care on behalf of the covered entity may be considered eligible providers for purposes of the 340B Program; 3) Indicating that case-by-case exceptions may be granted for covered entities seeking to expand their services to new sites outside of the normal enrollment process;4)Confirming that HRSA OPA is currently unable to waive the 340B statutory requirements related to the eligible patient definition and GPO prohibition;5) Clarifying that telehealth encounters remain eligible for 340B Program purposes; and 6) Moving toward conducting 340B Program covered entity audits remotely (virtually) for the next several months while HRSA OPA monitors and assesses the impact on the covered entities.
HRSA OPA's unprecedented actions will be evolving and are subject to change. 340B Program participants should carefully evaluate how these new flexibilities may enable them to expand existing services to rise to the unique challenge of this crisis.