On May 6, 2015, the Health Resources and Services Administration (HRSA) submitted guidance on the 340B Federal Drug Pricing Program (340B Program) to the federal Office of Management and Budget (OMB) for review. The guidance, entitled “340B Program Omnibus Guidelines,” is expected to address a broad range of topics within the 340B Program, including the definition of patient, contract pharmacy compliance requirements, hospital eligibility criteria and eligibility of off-site outpatient locations. HRSA has indicated publicly that the guidance will be in proposed form, and that there will be an opportunity for public comment before the guidance is finalized.

HRSA had been expected to issue a comprehensive, formal rule on the above-listed topics in 2014, and had submitted a proposed rule to OMB for review in April 2014. A federal district court decision on an unrelated 340B Program issued later in 2014, however, called into question HRSA’s authority to issue formal regulations on certain topics in the proposed rule, and thereafter HRSA withdrew the proposed rule.

Entities participating in the 340B Program should continue to monitor the status of the proposed guidance in the coming months. It is generally expected that the proposed guidance will be released this summer, but the timing will depend upon the completion of the OMB review. Participating entities in the 340B Program should be prepared to review and provide comments to HRSA regarding the proposed guidance. The proposed guidance is expected to include provisions that will make significant changes to the 340B Program, including changes that may have the potential to materially decrease future 340B Program revenue and increase 340B Program compliance obligations.