The Health Resources and Services Administration on May 20 published a proposed rule clarifying how it will implement the exclusion of orphan drugs under the 340B drug discount program for hospitals and rural referral centers newly eligible for the program under the Patient Protection and Affordable Care Act. With the exception of inpatient drugs and outpatient orphan drugs, the ACA expands eligible participants in the 340B program to include critical access hospitals and certain non-prospective payment system children’s hospitals, free-standing non-PPS cancer hospitals, and sole community hospitals and rural referral centers that have disproportionate share adjustment percentages equal to or greater than 8%.
Under the proposed rule, these newly covered entities could 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. HRSA will accept comments on the proposed rule through July 19.
[ via AHA News Now ]