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42 CFR 427.504

§ 427.504 Manufacturer access to Rebate Reports.

United States · 42 CFR — Public Health · Status: effective

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42 CFR 427.504, § 427.504 Manufacturer access to Rebate Reports, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/205486
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(a) General. CMS will establish a method and process for a manufacturer of the Part B rebatable drug to: (1) Access the manufacturer's Rebate Report as set forth in §§ 427.501 and 427.502, including any report of reconciled rebate amount as set forth in §§ 427.501(d) and 427.502(c)(2)(ii); (2) Submit a Suggestion of Error as set forth in §§ 427.502(c)(1)(ii) and (c)(2)(i) and 427.503; and (3) Pay a rebate amount as set forth in § 427.505. (b) [Reserved]

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.