Today the Health Resources and Services Administration (HRSA) released guidance for covered entities enrolled in the 340B Drug Pricing Program (340B Program) and for drug manufacturers that participate in the 340B Program. The purpose of the guidance is to assist 340B covered entities and drug manufacturers in complying with the statutory requirements of the 340B Program. The effects of the guidance will likely be far-reaching and will affect those who may be considered a patient of the covered entity under the 340B Program, contract pharmacy compliance requirements, and the eligibility of off-site outpatient locations. The guidance is proposed and not currently effective, and it includes a 60-day comment period. For any concerns related to the 340B Program, please contact Michael B. Glomb, Marisa B. Guevara, or Elizabeth J. Karan.
Visit our Health Law blog for future updates as we review this new guidance.