The elements of an effective compliance program provide a framework for life sciences companies to ensure their program is comprehensive and practicable. These same elements can be tailored to create an effective compliance training program for transparency reporting. By applying this framework to your transparency training, companies can enhance compliance with transparency reporting obligations, ensuring key messages are communicated and standards upheld.

Written Policies and Procedures
Robust documentation through formal, approved policies should outline, describe, and support a company’s commitment to timely and accurate reporting. These policies should address all transparency standards, including U.S. federal, state, and global requirements. Consideration should be given to establishing policies for managing a CMS audit. From these policies, SOPs, work instructions, user guides and guidance documents provide further detail on systems and processes, arming employees with the information needed to manage reporting effectively. Internal publication and LMS training integration ensure proper training is delivered to the relevant employees, such as those in state-specific roles.

Compliance Leadership and Oversight
Leadership buy-in is crucial for transparency reporting success. Senior leaders must understand its importance and provide resources when necessary, including personnel for reporting and access to external training support. Effective transparency training should begin during onboarding to set expectations early. While compliance training may be deprioritized, it is crucial to emphasize its value, especially for newly hired employees in HCP-facing roles where transfers of value are common. Periodic training updates should also be provided as employees progress or as new legislation emerges.

Effective Lines of Communication
Clear, consistent, thoughtful communication is key to effective transparency training. Both in-person and written communication play a role, with events such as National Sales Meetings offering opportunities for focused training. Designating compliance champions throughout the organization helps disseminate transparency messages, gather feedback, and ensure engagement. Regular newsletters and policy alerts also provide effective ways to keep employees informed.

Enforcing Standards
Establishing and maintaining standard processes for training employees and vendors is essential for compliance. With transparency data residing in multiple systems (e.g., Concur, CRMs, SaaS, ERPs), system-based training can help ensure data integrity. Early conversations with HCP-facing roles as well as finance professionals will have long-term benefits and avoid remediation efforts. Administrative professionals managing executive expense reports should also receive training, as their work also impacts compliance. Third-party vendors should be trained on the transparency reporting processes through required templates, live training on expectations and guidance material to ensure they meet company standards.

Risk Assessment, Auditing and Monitoring
Routine audits and assessments are vital to transparency compliance. Be transparent with auditing and monitoring activities and know your data’s value. Compliance professionals understand the importance of our obligations, however, field employees may not so educate employees on the “why” behind transparency reporting and look for opportunities for training enhancements. Seek to understand trends related to types of training like evaluating the length of time employees are taking to complete training relative to the accuracy of their transparency data. Field rides are valuable opportunities to monitor pain points from those who are managing and entering the data we clean, prepare, and submit. Share audit findings with executive leadership through dashboards and KPIs of your auditing and monitoring activities.

Responding to Detected Offenses and Developing Corrective Action
Educate employees on the consequences of non-compliance, both for themselves and the company. Establish an internal disciplinary matrix (e.g., coaching, written warnings) related to transparency-related offenses. CMS audits and global enforcement actions have increased the scrutiny of transparency data, so it is crucial to prepare employees, particularly those in state-specific roles, on the potential penalties for non-compliance of state jurisdictional requirements.

 

Jay Ward
Director, Life Science Solutions

November 6, 2024