{"data":{"id":"us/42-cfr-423.2716","jurisdiction":"us","citation":"42 CFR 423.2716","heading":"Phase-in of applicable discount for certain manufacturers.","body":"(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—\n(1) A Coverage Gap Discount Program agreement, as described at § 423.2315, in effect in accordance with § 423.2720(a)(1);\n(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\n(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.\n(b) Specified small manufacturer. Subject to the limitation with respect to manufacturer acquisition described at § 423.2724, a specified small manufacturer is a manufacturer of an applicable drug that, in 2021—\n(1) Is a specified manufacturer as described in paragraph (a) of this section; and\n(2) The total expenditures under Part D for any one of its specified small manufacturer drugs covered under a Coverage Gap Discount Program agreement for 2021 and covered under Part D in 2021 are equal to or greater than 80 percent of the total expenditures for all its specified small manufacturer drugs covered under Part D in 2021.\n(c) Aggregation rule. All entities, including corporations, partnerships, proprietorships, and other entities treated as a single employer under subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986 are treated as one manufacturer for purposes of this section.","path":["Title 42—Public Health","CHAPTER IV—CENTERS FOR MEDICARE \u0026 MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER B—MEDICARE PROGRAM","PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT","Subpart AA—Medicare Part D Manufacturer Discount Program"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-42.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:26:11Z","sha256":"6c2c923ce6b723a54b051888c351931852ec73248cac2c74ba980f0a67e9065c","source_id":"us-cfr","stale":true,"prev":"us/42-cfr-423.2712","next":"us/42-cfr-423.2720"},"notice":"GroundRules: Original legal text. Not legal advice."}