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Federal regulations · Through 2026-08-25 · Newer source version available

42 CFR 428.404: Manufacturer access to Rebate Reports.

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Where this section sits in the code
  1. Title 42—Public Health
  2. CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER B—MEDICARE PROGRAM
  4. PART 428—MEDICARE PART D DRUG INFLATION REBATE PROGRAM
  5. Subpart E—Reports of Rebate Amounts, Reconciliation, Suggestion of Error, and Payments

(a) General. CMS will establish a method and process for a manufacturer of the Part D rebatable drug to:

(1) Access the Rebate Report as set forth in §§ 428.401 and 428.402, including any report of a reconciled rebate amount as set forth in §§ 428.401 and 428.402;

(2) Submit a Suggestion of Error as set forth in §§ 428.402(c) and 428.403; and

(3) Pay a rebate amount as set forth in § 428.405.

(b) [Reserved]

Collected 2026-08-27T02:26:11Z. Source file · JSON

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