42 CFR § 428.404 - Manufacturer access to Rebate Reports.

---
identifier: "/us/cfr/t42/s428.404"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 428.404 - Manufacturer access to Rebate Reports."
title_number: 42
title_name: "Public Health"
section_number: "428.404"
section_name: "Manufacturer access to Rebate Reports."
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"
---


# 428.404 Manufacturer access to Rebate Reports.

(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]