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

42 CFR 428.405: Deadline and process for payment of rebate amount.

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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) Rebate amounts owed by a manufacturer. For payment of a rebate amount owed by a manufacturer:

(1) Upon receipt of a rebate amount, payment is due no later than 11:59 p.m. Pacific Time (PT) on the 30th calendar day after the date of receipt of information regarding the rebate amount on—

(i) A Rebate Report as set forth in § 428.401(c) or § 428.402; or

(ii) A report of a reconciled rebate amount as set forth in § 428.401(d) or § 428.402.

(2) Failure to pay a rebate amount due timely and in full may result in an enforcement action as described in subpart F of this part.

(b) Refund to the manufacturer. If a reconciled rebate amount for an applicable period as set forth in § 428.401(d) or § 428.402 is less than what the manufacturer paid for that applicable period, CMS will initiate the process to provide a refund equal to the excess amount paid within 60 days of the date of receipt of the report with such reconciled rebate amount.

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

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