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

---
identifier: "/us/cfr/t42/s428.405"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 428.405 - Deadline and process for payment of rebate amount."
title_number: 42
title_name: "Public Health"
section_number: "428.405"
section_name: "Deadline and process for payment of rebate amount."
chapter_name: "CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "MEDICARE PROGRAM"
part_number: "428"
part_name: "MEDICARE PART D DRUG INFLATION REBATE PROGRAM"
positive_law: false
currency: "2026-03-24"
last_updated: "2026-03-24"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 1395w-114b, 1302, and 1395hh."
regulatory_source: "89 FR 98588, Dec. 9, 2024, unless otherwise noted."
cfr_part: "428"
---


# 428.405 Deadline and process for payment of rebate amount.

(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.

[89 FR 98588, Dec. 9, 2024, as amended at 90 FR 50021, Nov. 5, 2025]