{"data":{"id":"us/42-cfr-423.2704","jurisdiction":"us","citation":"42 CFR 423.2704","heading":"Definitions.","body":"As used in this subpart and for purposes of the Manufacturer Discount Program, unless otherwise specified—\nAgreement holder means a manufacturer that has executed and has in effect its own Manufacturer Discount Program agreement in accordance with § 423.2708(b)(1).\nApplicable discount has the meaning set forth at § 423.2712.\nApplicable LIS percent has the meaning set forth at § 423.2712(d)(1).\nApplicable small manufacturer percent has the meaning set forth at § 423.2712(d)(2).\nCovered Part D drug has the meaning set forth at § 423.100.\nDispute submission deadline means the date that is 60 calendar days from the date of the invoice containing the information that is the subject of the agreement holder's dispute.\nNegotiated price has the meaning set forth at § 423.100, and with respect to an applicable drug under the Manufacturer Discount Program, such negotiated price includes any dispensing fee and, if applicable, any vaccine administration fee and sales tax.\nNetwork pharmacy has the meaning set forth at § 423.100.\nPart D drug has the meaning set forth at § 423.100.\nPrimary manufacturer has the meaning given such term pursuant to applicable regulations and guidance for the Medicare Drug Price Negotiation Program.\nSpecified drug means, with respect to a specified manufacturer, for 2021, an applicable drug that is produced, prepared, propagated, compounded, converted, or processed by the specified manufacturer.\nSpecified small manufacturer drug means, with respect to a specified small manufacturer, for 2021, an applicable drug that is produced, prepared, propagated, compounded, converted, or processed by the specified small manufacturer.\nTotal expenditures means with respect to—\n(1) Part D, the total gross covered prescription drug costs, as defined in § 423.308; and\n(2) Part B, the total Medicare allowed amount (i.e., total allowed charges), inclusive of beneficiary cost sharing, for Part B drugs and biologicals, except that expenditures for a drug or biological that are bundled or packaged into the payment for another service are excluded.","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":"8a57b1676b38673bb64e9b699b216251b3874338cd5950cfe82f52f8f80c954d","source_id":"us-cfr","stale":true,"prev":"us/42-cfr-423.2700","next":"us/42-cfr-423.2708"},"notice":"GroundRules: Original legal text. Not legal advice."}