CHA News Article

HRSA Releases 340B Orphan Drug Exclusion Final Rule

The Affordable Care Act (ACA) expands eligible participants in the 340B program to include critical access hospitals and certain non-prospective payment system (PPS) children’s hospitals, free-standing non-PPS cancer hospitals, and sole community hospitals and rural referral centers. In a recently published final rule, the Health Resources and Services Administration (HRSA) finalized its proposal to allow these newly covered entities to purchase outpatient orphan drugs at 340B prices to treat common conditions for which the drugs are approved, but not to treat the rare conditions or diseases for which the drugs were given their orphan drug designation. An FAQ is available at The final rule is attached and is effective Oct. 1.