{"data":{"id":"us/42-cfr-423.2310","jurisdiction":"us","citation":"42 CFR 423.2310","heading":"Condition for coverage of drugs under Part D.","body":"(a) Covered Part D drug coverage requirement. Except as specified in paragraph (b) of this section, in order for coverage to be available under Medicare Part D for applicable drugs of a manufacturer, the manufacturer must do all of the following:\n(1) Participate in the Coverage Gap Discount Program.\n(2) Have entered into and have in effect an agreement described in § 423.2315(b).\n(3) Have entered into and have in effect, under terms and conditions specified by CMS, a contract with the TPA.\n(b) Exception to covered drug coverage requirement. Paragraph (a) of this section does not apply to an applicable drug if CMS has made a determination that the availability of the applicable drug is essential to the health of beneficiaries enrolled in Medicare Part D.","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 W—Medicare Coverage Gap 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":"34a62145d8a532d99acbf89de07ca9cce0ab2bb0573cf9ca9bdc4b5a3b286c7f","source_id":"us-cfr","stale":true,"prev":"us/42-cfr-423.2305","next":"us/42-cfr-423.2315"},"notice":"GroundRules: Original legal text. Not legal advice."}