Specified manufacturer
(a) Specified manufacturer. Subject to the limitation with respect to manufacturer acquisitions described at 423.2724, a specified manufacturer is a manufacturer of an applicable drug that, in 2021, had (1) A Coverage Gap Discount Program agreement, as described at 423.2315, in effect in accordance with 423.2720(a)(1); (2) Total expenditures for all of its specified drugs (as defined in 423.2704) covered by a Coverage Gap Discount Program agreement for 2021 and covered under Part D in 2021 represented less than 1.0 percent of total expenditures for all Part D drugs in 2021; and (3) Total expenditures for all of its specified drugs that are single source drugs and biological products for which payment may be made under Part B in 2021 represented less than 1.0 percent of the total expenditures under Part B for all drugs or biological products in 2021.