As the Sunshine Act and Open Payments program continues to shine a light on financial transparency in healthcare, pharmaceutical manufacturers face heightened scrutiny over how they report payments or transfers of value (ToVs) to covered recipients. Even when data is submitted accurately, disputes from physicians and teaching hospitals are not uncommon. Handling these disputes promptly, transparently, and in full compliance with CMS regulations is critical—not only for regulatory adherence but also for maintaining trust with stakeholders. This blog outlines best practices for managing Open Payments disputes and highlights actionable steps manufacturers can take to minimize risk and foster transparency.
1. Understanding the Open Payments Dispute Process
The Centers for Medicare & Medicaid Services (CMS) allows covered recipients—such as physicians and teaching hospitals—to review and dispute reported payments or transfers of value submitted by pharmaceutical companies. These disputes can occur when recipients believe a reported amount is incorrect, misattributed, or lacks sufficient context.
Key areas that commonly trigger disputes include:
- Incorrect payment amount or date
- Misclassified nature of payment (e.g., travel vs. consulting fees)
- Inaccurate recipient information
- Duplicate record reporting
2. Step-by-Step Guide to Managing a Dispute
Step 1: Acknowledge the Dispute in the Open Payments System
Once notified of a dispute via the Open Payments portal, log into the system and formally acknowledge the dispute.
Step 2: Verify Original Data and Audit Trail
Review the initial data entry and audit any updates made before submission. Cross-reference internal systems and validate records.
Step 3: Review Specific Dispute Details
Confirm attributes like payment amount, date, recipient name, and payment category are clearly documented using original records.
Step 4: Initiate Contact with the Covered Recipient
Clarify the nature of the dispute respectfully and document all communications with the recipient.
Step 5: Conduct Internal Investigations
Collaborate with Legal, Compliance, and Finance teams to validate and resolve discrepancies.
Step 6: Resolve and Document
Update or delete disputed records, confirm resolution in writing, and document thoroughly.
Step 7: Re-Attestation and Statement of Assumptions
Re-attest the updated data and include an assumption statement to explain the resolution process.
3. Compliance Considerations
Proper documentation and timely resolution aren’t just best practices—they’re compliance imperatives. Failing to resolve disputes can lead to data suppression on the CMS website, potential audits, or reputational damage. Manufacturers should also maintain a formal dispute resolution policy, including timelines, documentation requirements, and responsibilities.
Key Takeaways
- Respond to disputes promptly and through official CMS channels.
- Always verify and cross-check disputed data before making changes.
- Maintain detailed documentation throughout the dispute resolution process.
- Collaborate with internal departments to maintain consistency and compliance.
- Communicate clearly and respectfully with covered recipients.
- Re-attest and include assumption statements to explain changes.
Call to Action
Navigating the complexities of Open Payments disputes doesn’t have to be overwhelming. QPharma’s Aggregate Spend experts are here to help safeguard your reporting process is compliant, efficient, and fully documented from start to finish. Visit qpharmacorp.com to learn more about our aggregate spend solution or contact us to speak with a compliance specialist today.
