In Part 1 of this series, we explored the complex regulatory landscape surrounding the pharmaceutical industry, emphasizing the importance of compliance with regulations like the Open Payments Program. To effectively navigate this landscape and prepare for potential CMS audits, a comprehensive transparency assessment is crucial. In our experience, one of the most effective ways to prepare for a CMS audit is to conduct an internal CMS mock audit, identify gaps, address key findings and ensure comprehensive audit-readiness.
Such “mock CMS audits” can involve several key tasks:
- Identify Impacted Areas: Identify key business areas impacted by these reporting requirements and ensure data owners from across the organization are fully aware and involved in their responsibilities.
- Define Data and Capture Protocols: Meticulously define the required data elements and develop robust data capture protocols to ensure accurate and consistent data collection.
- Review Internal Processes: Thoroughly review existing internal policies, procedures, and work instructions for data capture. This review should evaluate the alignment with regulatory requirements, ensuring a harmonized approach across all departments, including those involving vendor-managed activities. This includes defining applicable covered recipients (i.e., HCPs), aligning data mapping for federal and state-specific terminology, establishing data feed schedules, and evaluating the capabilities of existing data capture systems and processes.
- Address Key Considerations: Address critical aspects such as dispute resolution processes, training programs for employees involved in data collection, and robust document retention procedures.
- Implement Data Stewardship: Implement a robust data stewardship framework, including processes for reviewing data for missing, malformed, or anomalous entries. Establish clear data correction procedures to ensure data accuracy.
- Implement Continuous Monitoring: Implement ongoing data auditing and monitoring procedures to identify and address any emerging issues or regulatory changes.
Life-sciences companies can expect the following as outcomes of the mock audit:
- Development of an Activity and Event Checklist: This comprehensive checklist can serve as a valuable tool for identifying all activities, events, and interactions impacted by the reporting requirements. It can also clearly define the individuals or groups responsible for data collection in each area.
- Delivery of an Assessment & Audit Readiness Report: This detailed report can provide valuable insights, including observations, recommendations, and a roadmap to enhance the company’s transparency and compliance program.
By conducting a thorough transparency assessment, companies can identify potential areas of non-compliance, address gaps in their reporting systems, and ultimately strengthen their overall compliance posture. This proactive approach will not only minimize the risk of costly audits but also enhance the company’s reputation and build trust with stakeholders.
Contact us to learn how QPharma can assist with conducting a comprehensive mock CMS Audit
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