Understanding CMS’s 2025 Guidelines for PDE Analysis Website and Data Quality Reviews

Relevant to: PDP, PDF, TrOOP, Part D

Each week, we scan the latest CMS memos to find the most important ones that apply for PACE programs. Below is a summary of what you need to know.

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 Centers for Medicare & Medicaid Services (CMS) is reaching out to Part D Sponsors with a crucial update on the Prescription Drug Event (PDE) Analysis Website. This update focuses on data quality review, outliers, and handling invoiced data disputes. Part D Sponsors are expected to engage in comprehensive reviews, adhering to existing guidelines, to maintain accuracy and transparency in Medicare drug event data.

Key Dates and Deadlines

  • Date of Memorandum: January 17, 2025
  • Retroactive disenrollment of the beneficiary and closed pharmacy or inactive Service Provider ID implementation: Q1 2025
  • Retroactive low-income status of the beneficiary and retroactive non-low-income status of the beneficiary implementation: Q2 2025
  • Retroactive phase-in NDC and retroactive non-phase-in NDC implementation: Q3 2025
  • Calculated TrOOP outlier types implementation: Q4 2025
  • User authorization process deadline: 2 weeks from the date of this memorandum

PACE Compliance

This memo is relevant to PACE programs because it involves the Prescription Drug Event (PDE) Analysis Website for CMS Data Quality Review. PACE providers who also participate in Medicare Part D may have similar obligations when it comes to reviewing and responding to PDE records and outliers.

Plans must ensure compliance with the data quality review process by:

– Monitoring notifications from the PDE Analysis website for records requiring review.
– Downloading and reviewing reports that detail identified issues, including pricing errors, misreporting, or potential duplicate transactions.
– Completing and submitting a Response Form documenting the validity of the PDE records.
– Ensuring timely responses within the specific calendar days defined for various outlier types and disputes.
– Making necessary adjustments or deletions to PDE records within a 90-day window if inaccuracies are discovered, consistent with existing HPMS guidance.

Additionally, any changes in beneficiary status, such as low-income status or enrollment status, must be accurately reflected in the PDE records to avoid being flagged as outliers.

Failing to comply with these requirements may result in withheld or invalidated PDE records, which could impact payment reconciliations and manufacturer invoicing.

Required Actions

  1. Access the PDE Analysis website promptly when receiving notifications for reviewable PDE records. Conduct thorough research on PDE records to verify data accuracy and validity.
  2. Respond to outlier or dispute postings in a timely manner – 14 calendar days for outliers and 10 calendar days for manufacturer disputes. Submit the completed Response Form for each posted PDE.
  3. Make necessary PDE adjustments or deletions within 90 days post-notification, adhering to the guidance issued on October 6, 2011.

FAQs

  • What is the Prescription Drug Event (PDE) Analysis Website used for?
  • How can Part D sponsors access the PDE Analysis Website?
  • What are the key categories of data quality review outliers?
  • What is the process for handling withhold and invoiced outlier PDE records?
  • How do manufacturers dispute invoiced discount payments under CGDP and MDP?

Click here to read the complete memo from CMS.

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