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Therefore, to maintain operational feasibility of this provision and better align the policy with statutory language when the date of first sale reported to CMS does not adequately approximate the date of first payment under Medicare Part B, we proposed to amend the exclusions in the definition of refundable single-dose container or single-use package drug at 414.902

Clinically, TBI manifests through a spectrum of symptoms ranging from coma and headache to behavioral dysfunctions such as aphasia, seizures, amnesia, aggression, and anxiety [2,3]