Law360, New York (September 3, 2015, 11:35 AM EDT) -- New guidance from the U.S. Health Resources Services Administration clarifying certain definitions integral to the 340B Drug Pricing Program will significantly limit the number of patients eligible to receive 340B drugs, resulting in substantial increases in prescription drug costs for many 340B-participating health care providers.[1] The guidance contains a six-part test for an "eligible patient," substantially more onerous to meet than HRSA's previous three-part test and directly conflicting with previous guidance issued by HRSA. If this new "patient" definition is finalized, we expect that many 340B covered entities will be significantly affected and see a material reduction in the number of patients eligible to receive 340B discounted drugs. This decrease will result in higher pharmaceutical drug costs for these covered entities and potentially significant economic consequences. Additionally, the "clarifying" nature of the new guidance indicates that 340B hospitals may be subject to retroactive audits from both manufacturers and HRSA, applying the narrowed patient definition to prior time periods and resulting in hospital refunds to drug manufacturers. Covered entities will likely need to revise their 340B Program compliance and prepare for audits. Comments to the proposed guidance are due no later than Oct. 27, 2015....