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[158] We refer to this payment as the empirically justified Medicare DSH payment. In addition to this empirically justified Medicare DSH payment, section 1886(r)(2) of the Act provides that, for FY 2014 and each subsequent fiscal year, the Secretary shall pay to such subsection (d) hospital an additional amount equal to the product of three factors

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That research has not yet progressed to randomized, controlled human clinical trials for any indication - a distinction that applies across the entire BPC-157 product category, not just to ProHealth's formulation