HRSA Proposes to Permit 340B Orphan Drug Coverage at Rural Hospitals - May 24, 2011

The federal Health Resources and Services Administration (HRSA) on May 20 issued a notice of proposed rulemaking that would permit certain rural hospitals in some instances to purchase orphan drugs at discounted prices under the 340B drug discount program. The Affordable Care Act added new covered entities including critical access hospitals, rural referral centers and sole community hospitals to the 340B program but barred these entities from purchasing orphan drugs at a discount through the program. HRSA’s proposed rule would reduce some of these restrictions when orphan drugs are used for non-rare conditions. Some stakeholders continue to advocate that a completely lifting the orphan drug exclusion is necessary in order to accomplish the goals of 340B, and are urging Congress to lift the ban. Comments on HRSA’s proposed rule are due by July 19.