Medicare Part D Manufacturer Discount Program Labeler Code Guide for 2025
Relevant to: PDP, Drug Manufacturer Module Enhancements, 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 have introduced the Part D Manufacturer Discount Program, commencing on January 1, 2025. This initiative focuses on ensuring Medicare Part D sponsors, manufacturers, and pharmacies have access to brand-name drugs and biologics with labeler codes under a Manufacturer Discount Program agreement. An essential tool, the Manufacturer Discount Program Labeler Code README File, is available in multiple file formats to assist relevant entities in navigating details of the program. This file includes crucial fields such as labeler codes and dates relevant to the effective management of discounts under the new program.
Key Dates and Deadlines
- Manufacturer Discount Program Start Date: January 1, 2025
- Monthly File Update with Terminated Labeler Code: End of the Month Following Termination (e.g., Termination on March 31, 2025, File Updated in April 2025)
- Removal from File: Month After Updated File (e.g., Removed from May 2025 File for March 31, 2025 Termination)
PACE Compliance
This memo is relevant to PACE programs due to its impact on how prescription drug coverage is administered under Medicare Part D, which may include PACE participants. The introduction of the Manufacturer Discount Program affects the financial dynamics of Part D drug coverage, particularly with the inclusion of discounts on brand-name drugs and biologics.
Plans, including those involving PACE participants, need to comply with the Manufacturer Discount Program agreements that have commenced as of January 1, 2025. PACE programs should ensure that all covered drugs under their plans have the appropriate labeler codes listed in the Manufacturer Discount Program Labeler Code README File to secure the applicable discounts.
To remain compliant:
– Confirm that any drugs provided under the PACE program fall under the agreements of the Manufacturer Discount Program, effective from January 1, 2025.
– Regularly review the Manufacturer Discount Program Labeler Code README File for updates, as these will indicate which drugs are covered, ensuring cost savings are passed on where applicable.
– Utilize the file formats and importing methods described, especially when dealing with CSV files, to maintain data integrity for compliance verification.
Non-compliance with these requirements could result in financial discrepancies and reduced availability of covered drugs for PACE participants.
Required Actions
1. Download the Manufacturer Discount Program Labeler Code file in your preferred format (Excel, CSV, or Text) from the Part D Information for Pharmaceutical Manufacturers webpage on the CMS website.
2. If working with the CSV file, be cautious about potential auto-formatting issues in Excel that may alter displayed data, such as removing leading zeros from labeler codes. To preserve the intended data format, consider using the Excel text import wizard or importing the text file by connecting to and transforming it.
3. Review the file contents for relevant labeler codes, checking the fields such as P Number, Manufacturer Name, and Labeler Code, among others, to ensure compliance with the Manufacturer Discount Program guidelines.
FAQs
- “What is the Medicare Part D Manufacturer Discount Program?”
- “How can I access the Manufacturer Discount Program Labeler Code file?”
- “What information is included in the labeler code file?”
- “How do I properly open a .csv file to maintain data format integrity?”
