42 CFR § 423.325 - PDE submission timeliness requirements.

---
identifier: "/us/cfr/t42/s423.325"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 423.325 - PDE submission timeliness requirements."
title_number: 42
title_name: "Public Health"
section_number: "423.325"
section_name: "PDE submission timeliness requirements."
chapter_name: "CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "MEDICARE PROGRAM"
part_number: "423"
part_name: "VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh."
regulatory_source: "70 FR 4525, Jan. 28, 2005, unless otherwise noted."
cfr_part: "423"
---


# 423.325 PDE submission timeliness requirements.

(a) *General PDE submission timeliness requirements.* Unless paragraph (b) of this section applies, a Part D sponsor must submit PDE records to CMS as follows:

(1) Initial PDE records within 30 calendar days from the date the Part D sponsor (or its contracted first tier, downstream, or related entity) receives the claim.

(2) Adjustment or deletion PDE records within 90 calendar days of the Part D sponsor (or its contracted first tier, downstream, or related entity) discovering or receiving notification of an issue that requires a change to the previously submitted PDE record.

(3) Revised PDE records to resolve CMS rejected records within 90 calendar days of the rejection.

(b) *Selected Drugs PDE submission timeliness requirement.* A Part D sponsor must submit initial PDE records for selected drugs (as described at section 1192(c) of the Act) within 7 calendar days from the date the Part D sponsor (or its contracted first tier, downstream, or related entity) receives the claim.

[90 FR 15919, Apr. 15, 2025]