Crosswalk CMS-10174_11-2023

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Collection of Prescription Drug Event Data 
From Contracted Part D Providers for Payment 
CMS-10174/OMB 0938-0982 Crosswalk
Section
New version
Type of Change
Reason for change
Burden Change
Background and Legal Basis sections
Revised for clarity and readability.
Updated data within each of the existing PDE data categories to align with guidance. Added 42 CF 423.325 and Subpart AA of part 423 to the list of applicable regulations for completeness.
Rev
Accuracy
No
Information Users
Revised for clarity and readability.

Rev
Accuracy
No
Use of Information Technology
Revised for clarity and readability.
Updated to reflect the PDE submission requirements codified at 42 CFR 423.325.
Rev
Accuracy
No
Less Frequent Collection
Revised for clarity and readability.
Updated to reflect the PDE submission requirements codified at 42 CFR 423.325.
Rev
Accuracy
No
Ongoing Communication and Information Collection/Reporting Instruments and Instruction/Guidance Documents 
Revised the list to update relevant guidance and HPMS memoranda related to PDE submissions.
Rev
Accuracy
No
Active Collection of Information and Associated Burden Estimates
Revised text to identify updated costs and burdens.
Rev
Accuracy
Yes
One-Time Burden Estimates Resulting from New Valid Values to Existing PDE Fields
Added a new one-time burden associated with system and file changes to accommodate new valid values to existing PDE record fields.
Add
Accuracy
Yes
Information Collection/Reporting Instruments and Instruction/Guidance Documents
Revised to include guidance and HPMS memoranda relevant to PDE submissions.
Rev
Accuracy
No
Submission Requirements
Revised for clarity and readability.

Rev
Accuracy
No
Collection of Prescription Drug Event Data
Revised for clarity and readability. Updated to reflect sponsor PDE submissions to include Sundays.

Rev
Accuracy
No
Capital Costs
Revised to reflect updated number of Part D contracts for update years.
Rev
Accuracy
No
Cost to Federal Government
Revised to reflect updated costs.
Rev
Accuracy
No
Changes to Requirements and Burden
Revised to reflect updated costs and burden.
Rev
Accuracy
No
Changes to Requirements and Burden
Added a new one-time burden associated with system and file changes to accommodate new valid values to existing PDE record fields.
Add
Accuracy
Yes
Attachments to the Supporting Statement
Added the following guidance documents (HPMS memoranda) and other supporting files as attachments to the Supporting Statement:
Clarification of Prescription Drug Event (PDE) Reporting Requirements for 340B Identification [PDF].pdf, May 01, 2026
2026 Prescription Drug Event (PDE) File Layout Updates_2026_prescription_drug_event_file_layout_updates [PDF].pdf and 2026 Prescription Drug Event (PDE) File Layout Updates_ pde_outbound_file_layout_effective_01012026 [XLSX].xlsx, September 30, 2025
End of Year Prescription Drug Event Submission Instructions to Facilitate Transition to 1000-byte File Layout [PDF].pdf, November 22, 2024
Prescription Drug Event Submission Certification Requirements for 2025 for PACE Organizations [PDF].pdf, July 12, 2024
Additional Information Regarding Prescription Drug Event Submission Certification for 2025 [PDF].pdf, June 28, 2024
Prescription Drug Event Submission Certification Requirements for 2025 [PDF].pdf, May 10, 2024
May 2024 Updates to the Drug Data Processing System (DDPS)  [PDF].pdf, May 10, 2024
2025 Prescription Drug Event (PDE) File Layout Updates for all Part D Plan Sponsors, and Additional 2025 Changes to PDE Reporting for PACE Organizations.pdf, and 2025 Prescription Drug Event (PDE) File Layout Updates for all Part D Plan Sponsors, and Additional 2025 Changes to PDE Reporting for PACE.xlsx, March 08, 2024
Add
Accuracy
No