42 CFR § 428.402 - Rebate Reports for applicable periods beginning October 1, 2022, and October 1, 2023.

---
identifier: "/us/cfr/t42/s428.402"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 428.402 - Rebate Reports for applicable periods beginning October 1, 2022, and October 1, 2023."
title_number: 42
title_name: "Public Health"
section_number: "428.402"
section_name: "Rebate Reports for applicable periods beginning October 1, 2022, and October 1, 2023."
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"
---


# 428.402 Rebate Reports for applicable periods beginning October 1, 2022, and October 1, 2023.

(a) *Transition rule for reporting.* Section 1860D-14B(a)(3) of the Act allows CMS to delay the timeframe for reporting the information and rebate amount set forth in § 428.401 for the applicable periods beginning October 1, 2022, and October 1, 2023, until not later than December 31, 2025.

(b) *Rebate Report information for applicable periods beginning October 1, 2022, and October 1, 2023.* The Rebate Reports for the applicable periods beginning October 1, 2022, and October 1, 2023, will include the information set forth in § 428.401(b)(1).

(c) *Rebate Report procedures for applicable periods beginning October 1, 2022, and October 1, 2023.* Rebate amounts for the applicable periods beginning October 1, 2022, and October 1, 2023, will be reported as follows:

(1) The Rebate Report for the applicable period beginning October 1, 2022, will be issued no later than December 31, 2025. The Preliminary Rebate Report for such applicable period will be issued at least 1 month prior to the Rebate Report.

(i) For this single Preliminary Rebate Report for the applicable period, the Suggestion of Error period as set forth in § 428.403 will be 30 calendar days.

(ii) The rebate amount will be reconciled within 21 months after the Rebate Report set forth in this paragraph (c)(1) is issued to include the information set forth in § 428.401(d)(1)(i)(A) through (G).

(iii) The Suggestion of Error period for the reconciliation set forth in paragraph (c)(1)(ii) of this section will be 10 calendar days.

(2) The Rebate Report for the applicable period beginning October 1, 2023, will be issued no later than December 31, 2025. The Preliminary Rebate Report for such applicable period will be issued at least 1 month prior to the Rebate Report.

(i) For this single Preliminary Rebate Report for the applicable period, the Suggestion of Error period as set forth in § 428.403 will be 30 calendar days.

(ii) The rebate amount will be reconciled within 9 months after the Rebate Report and within 33 months after the Rebate Report specified in this paragraph (c)(2) is issued to include the information determined under § 428.401(d)(1)(i)(A) through (G).

[89 FR 98588, Dec. 9, 2024, as amended at 90 FR 50021, Nov. 5, 2025; 91 FR 12081, Mar. 12, 2026]