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Additionally, we are proposing to expand the types of Part B medications assigned to the measure because we believe it would be appropriate to use similar service assignment rules for all clinically-related Part B medications

(3) For a covered Part D drug identified in the PDE that is approved under an ANDA under section 505(j) of the FD&C Act, CMS will determine whether such drug meets the criteria in section 1860D-14B(g)(1)(C)(ii) of the Act as of the first day of the applicable period as follows: (i) To determine whether the reference listed drug or an authorized generic of the reference listed drug is being marketed, as required under section 1860D-14B(g)(1)(C)(ii)(I) of the Act, CMS will use FDA's NDC Directory, including historical information from NDC Directory files such as discontinued, delisted, and expired listings, provided by the FDA or published on the FDA website

We have assigned a proportion of the global package payment to each portion of the service based on longstanding assumptions

We invite public comment on this proposal

of this proposed rule, we discussed drugs covered as additional preventive services (henceforth DCAPS drugs, for the ease of the reader)