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In 427.401(b)(2), CMS proposes codifying the policy set forth in section 50.11 of the revised Medicare Part B Drug Inflation Rebate Guidance to apply a greater applicable percent reduction for plasma-derived products than non-plasma derived products because the former rely on a variable supply of donated blood plasma that can impact downstream production and therefore hamper the ability to promptly resolve a shortage

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Fan J, Zhou Y, Meng R, Tang J, Zhu J, Aldrich MC, et al