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New CMS Guidelines for Part D Sponsors in 2025: What You Need to Know

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CMS-Guidelines

The Centers for Medicare & Medicaid Services (CMS) recently announced changes to the Coordination of Benefits-Other Health Insurance (COB-OHI) file process for Part D sponsors, starting March 17, 2025. These updates are designed to improve data accuracy while ensuring seamless compliance with CMS regulations. However, for Part D sponsors, these changes introduce new considerations for data management and operational planning.  

This post will guide you through the key updates, potential challenges, and actionable strategies to ensure compliance with the new CMS guidelines.  

What Are the New CMS Guidelines?  

Starting in 2025, Part D sponsors will receive an annual COB-OHI full replacement file that includes all beneficiaries with active or prior Part D enrollment within the past three years and are identified as having primary (PRM) or supplemental (SUP) prescription drug coverage.  

The changes involve critical updates to file transmissions, naming conventions, delivery timelines, and the temporary halt of daily COB-OHI file updates. These guidelines aim to streamline the process and enhance the integrity of beneficiary coverage records.  

Key Features of the Annual COB-OHI File  

  • Comprehensive Beneficiary Records  

The annual COB-OHI file will include records for beneficiaries with PRM or SUP drug coverage and an OHI termination date within the last seven years. However, it excludes records for beneficiaries who were terminated from Part D enrollment more than 36 months before the file’s generation.  

  • File Name Details  

The annual file will include the term “MARXCOBA” in the file name, differentiating it from daily updates. A summary file sent at the transmission’s conclusion will include the naming convention “MARXCOBS,” listing all files transmitted to enable validation.  

  • Interruption of Daily Transmissions  

Daily COB-OHI updates will cease during the one-to-four-day process of transmitting the annual COB-OHI file. Files for updates during this period will resume within approximately one week after the full replacement files are sent.  

The Annual COB-OHI File Process  

Beneficiary Inclusion Criteria  

Beneficiaries included in the annual file are limited to those who meet the following criteria: 

  • They are currently active or were active in the past 36 months on a Part D plan.  
  • They have PRM or SUP prescription drug OHI coverage in the Benefits Coordination & Recovery Center (BCRC) system, with a termination date within the prior seven years.  

Exclusions  

The file does not include “Detail-only” records for beneficiaries whose other coverage data was deleted from the CMS BCRC system. This means sponsors should not expect to receive OHI records for beneficiaries who have no current PRM or SUP data in the BCRC system.  

Delivery Timelines and File Size  

Due to size constraints, the full replacement file may be delivered in multiple parts over a one-to-four-day period. Plan sponsors should anticipate potentially large file sizes and allocate adequate IT resources to manage them.  

Key Compliance Concerns for Part D Sponsors  

The new guidelines present several operational and compliance challenges for organizations. Below are some of the most critical concerns along with strategies to address them.  

1. Maintaining Data Accuracy  

Challenge  

File accuracy is paramount for Part D sponsors, as CMS requires flawless data management for compliance. Sponsors must investigate discrepancies such as unexpected OHI records or missing data.  

Solution  
  • Implement rigorous data validation processes to cross-reference internal systems against COB-OHI files.  
  • Regularly audit internal beneficiary records to ensure they align with CMS data.  

2. Managing Interrupted Daily File Transmissions  

Challenge  

Daily file updates will halt for an extended period during the processing of the annual full replacement file, potentially disrupting workflows and compliance routines.  

Solution  
  • Develop a clear communication plan to notify relevant teams about the temporary halt and its impact.  
  • Schedule tasks and allocate resources in advance to manage the delayed updates after daily file transmissions resume.  

3. Adhering to File Naming Conventions  

Challenge  

It’s critical that Part D sponsors correctly identify the annual COB-OHI files. Misinterpreted or overlooked files could lead to compliance issues.  

Solution  
  • Train data management and IT teams on the new naming conventions (“MARXCOBA” and “MARXCOBS”).  
  • Use automated tools to search and process files based on their updated naming formats.  

4. Handling Large File Sizes  

Challenge  

The size and volume of the annual COB-OHI files may overwhelm existing IT infrastructure, delaying timely processing.  

Solution  
  • Ensure advanced IT infrastructure and sufficient storage capacity to handle large files efficiently.  
  • Allocate personnel to monitor file deliveries and address bottlenecks promptly.  

5. Meeting Strict Processing Deadlines  

Challenge  

Sponsors must integrate and process the full replacement file within the timeline specified by CMS, leaving no room for delays or errors.  

Solution  
  • Dedicate resources and clearly define roles within the team to ensure compliance with deadlines.  
  • A backup team should be available in case of unforeseen delays or technical issues.  

What Part D Sponsors Need to Do  

To prepare for these changes and ensure compliance, Part D sponsors must follow these key steps: 

  • By March 17, 2025, ensure IT and compliance teams are familiar with the new file naming conventions and delivery schedules.  
  • Proactively audit your data management processes and implement validation steps to integrate the full replacement files without errors.  
  • Allocate IT resources and develop a plan for managing large file sizes and multiple deliveries.  
  • Communicate changes to all relevant teams, ensuring minimal disruption to operations during the temporary halt of daily file updates.  
  • Monitor CMS email notifications for updates on file transmissions and timelines for the resumption of daily COB-OHI files.  

Ensuring Compliance Amid Change  

The new CMS guidelines mark a significant shift in the way Part D sponsors process and manage COB-OHI files. While the annual full replacement file offers an opportunity to enhance data accuracy, preparing for potential operational challenges is crucial to ensure compliance.  

By adopting proactive strategies such as robust data validation, resource planning, and clear communication, Part D sponsors can seamlessly align their processes with the updated guidelines.  

For more details on file layouts and records, refer to the CMS Plan Communication User Guide (PCUG) or contact the MAPD Help Desk. Staying informed and prepared will enable sponsors to leverage this transition for operational excellence.  

How Inovaare Can Help 

Inovaare has tools and human resources to support Sponsors with their regulatory compliance requirements. If you have questions, write us at info@inovaare.com and one of our compliance experts will get back to you.  

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