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CMS intends to apply this unit exclusion at the month level and would exclude all units of a generic drug that ceases to meet the definition of a Part D rebatable drug beginning with the first day of the first month when a therapeutically equivalent drug approved under a 505(j) ANDA is marketed based on the marketing start date in the NDC Directory or when the reference listed drug, or an authorized generic of the reference listed drug is marketed based on the marketing start date in the NDC Directory

Estimation framework According to the theoretical structure of comparative risk assessment, GBD 2019 estimated the proportion of disease burden caused by a risk factor in a given population by comparing the exposure distribution of that risk factor with the theoretical minimum risk exposure distribution, assuming that the exposure levels of other risk factors remain unchanged (Hashibe et al

We also finalized that for a drug to meet the definition of refundable drug, all NDCs assigned to the drug's billing and payment code must be single-dose containers, as described in each product's labeling