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HRSA issues final rule for 340B orphan drug exclusion

July 26, 2013

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The Health Resources and Services Administration (HRSA) July 23 published a final 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.” The law 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 that have disproportionate share adjustment percentages equal to or greater than 8%.

HRSA said the rule “will provide clarity in the marketplace, maintain 340B savings for newly-eligible covered entities, and protect the financial incentives for manufacturing orphan drugs designated for a rare disease or condition as indicated in the Affordable Care Act and intended by Congress.” Like the proposed rule, the final rule allows 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. For more information, click on: http://tinyurl.com/mho5qnr.