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Examples include: Tuberculosis testing Allergy testing procedures Documentation must identify the route and purpose of administration

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We proposed that CMS will not provide a full waiver of the rebate amount for drugs currently in shortage, as providing a full waiver of the rebate amount could further incentivize manufacturers to delay taking appropriate steps that may resolve a shortage more expeditiously simply to maintain having the drug listed on FDA's drug shortage list to avoid an obligation to pay rebates for an extended period