---
kind: "section"
citation: "42 C.F.R. § 428.404"
title: "42"
number: "428.404"
heading: "Manufacturer access to Rebate Reports."
url: "https://uscodex.org/cfr/42/428.404"
---

# §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](/cfr/42/428.401.md) and [428.402](/cfr/42/428.402.md), including any report of a reconciled rebate amount as set forth in §§ [428.401](/cfr/42/428.401.md) and [428.402](/cfr/42/428.402.md);
  - (2) Submit a Suggestion of Error as set forth in §§ [428.402(c)](/cfr/42/428.402.md?p=c) and [428.403](/cfr/42/428.403.md); and
  - (3) Pay a rebate amount as set forth in [§ 428.405](/cfr/42/428.405.md).
- (b) [Reserved]

## Notes

### Authority

Authority: 42 U.S.C. 1395w-114b, 1302, and 1395hh.

### Source

Source: 89 FR 98588, Dec. 9, 2024, unless otherwise noted.