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At 427.401(b)(2), we proposed to codify 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

At 427.402(c)(6)(iii), we proposed that CMS' decision to deny a request will be final and not be subject to an appeals process

Key Citation Heffernan MA et al