Prescription Drug Event Reporting: 2026 Inflation Reduction Act Instructions

Relevant to: PDP, PDF, TrOOP, PACE, Part D

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Disclaimer: The content provided on this site is a summary for informational purposes only, and Grane PBM, Inc. assumes no liability for any errors or omissions in the site’s content. The information does not constitute legal or regulatory advice or replace the original CMS memo. Readers are advised to consult the CMS memo in its entirety and to verify information independently before making any decisions based on this information.

Click here to read the complete memo from CMS.

Introduction

The Department of Health & Human Services has issued new Prescription Drug Event (PDE) Record Reporting Instructions for the implementation of the Inflation Reduction Act for Contract Year 2026. These instructions, effective January 1, 2026, provide vital guidance consistent with the Inflation Reduction Act of 2022 for all Part D sponsors, including Programs of All-Inclusive Care for the Elderly (PACE) organizations. The memorandum details PDE examples for various scenarios and encourages sponsors to direct any questions to the provided contact email. This comprehensive document ensures that Part D plan sponsors are equipped for the 2026 contract year changes.

Key Dates and Deadlines

  • Memo Date: April 15, 2025
  • Implementation of Inflation Reduction Act: January 1, 2026
  • Contract Year 2026 starts: January 1, 2026
  • Reference Date for PACE organizations changes: January 1, 2025
  • CMS Memorandum publication Date: March 8, 2024

PACE Compliance

This memo is relevant to PACE programs because of its implications on Prescription Drug Event (PDE) record reporting. PACE organizations, as part of Part D plan sponsors, must adhere to the new PDE record reporting instructions that are consistent with the provisions of the Inflation Reduction Act of 2022, effective January 1, 2026.

For PACE organizations, it is crucial to:

  • Follow the guidance specified in the memorandum, including the specific PDE examples for contract year 2026.
  • Refer to the CMS memorandum titled “2025 Prescription Drug Event File Layout Updates for all Part D Plan Sponsors, and Additional 2025 Changes to PDE Reporting for PACE Organizations” published March 8, 2024, for any changes that were effective starting January 1, 2025.

This ensures compliance with the updated reporting structure and helps in maintaining the correct reporting standards for PACE organizations under the Part D program.

Required Actions

HTML_required_actions: The memorandum outlines important information for all Part D Plan Sponsors regarding the Prescription Drug Event (PDE) reporting instructions effective January 1, 2026, in line with the Inflation Reduction Act (IRA) of 2022. Below are the fundamental actions that need to be taken:

1. Review the PDE reporting instructions that are specified in the memorandum for the effective period starting January 1, 2026, to ensure adherence to the new rules.

2. Familiarize yourself with the plan-specific PDE examples provided for Calculating and Reporting the Selected Drug Subsidy, Non-Calendar Year (NYY) Employer Group Waiver Plans (EGWPs), and Covered Insulin Product Lesser of Logic, as these are pivotal elements for compliance in CY 2026.

3. Direct any questions regarding this memorandum to the provided email address (PDE-Operations@cms.hhs.gov) to ensure clarity and to address any discrepancies in understanding the directives given.

FAQs

  • “What are the Prescription Drug Event record reporting instructions for contract year 2026?”
  • “How does the Inflation Reduction Act impact Part D sponsors in contract year 2026?”
  • “What specific sections are covered in the PDE reporting instructions for 2026?”
  • “How does the Selected Drug Subsidy apply in the PDE reporting process?”
  • “What examples are provided for reporting under NCY EGWPs in 2026?”

Click here to read the complete memo from CMS.

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