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As proposed in 427.402(c)(4), CMS would grant a reduction in the rebate amount owed if a manufacturer of an eligible drug submits to CMS a request in writing demonstrating supply chain disruption has occurred during the calendar quarter, (2) the severe supply chain disruption directly affects the manufacturer itself, a supplier of an ingredient or packaging, a contract manufacturer, [577] or a method of shipping or distribution that the manufacturer uses in a significant capacity to make or distribute the Part B rebatable biosimilar biological product, and (3) the severe supply chain disruption was caused by a natural disaster or other unique or unexpected event

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