Under the Public Health Service Act’s Section 340B drug pricing program (“340B Program”), manufacturers who sell covered outpatient drugs to specific federal grantees, federally-qualified health center look-alikes, and qualified disproportionate share hospitals (“covered entities”) must agree to charge less than the statutorily-prescribed maximum price for those drugs. This results in significant savings on drugs for the covered entities. Previously, the Health Resources and Services Administration (“HRSA”) Office of Pharmacy Affairs (“OPA”) had specified procedures under which discounts could be made available to covered entities engaging a single contract pharmacy, and had conducted an Alternative Methods Demonstration Project (“AMDP”) program in which HRSA approved a limited number of covered entities using multiple contract pharmacies.

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