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To determine whether a generic drug that meets the definition of a Part D rebatable drug on the first day of an applicable period ceases to meet such definition later in the applicable period, CMS will use the most recent version of the downloadable FDA Orange Book to identify whether FDA has approved a 505(j) ANDA for a drug that is rated as therapeutically equivalent to such generic drug

To assess this alternative value, we ran a separate RIA model with a performance threshold of 86

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of this proposed rule, we do not believe additional regulation text changes are needed to conform to the coverage proposal, as the update to the definition at 410.63(a) will apply to the use of the definition in these regulations: Section 410.10(p)