Are you doing everything you can to ensure your sales force is staying compliant and following the rules? To keep your company in safe harbor, compare the following checklist with your existing sales and compliance practices:
Are your current monitoring practices based on a risk mitigation analysis and strategy?
Your monitoring efforts should be focused on the prioritized areas most likely to land your company in hot water. This will be based in part on "hot trends" in investigations and enforcement, and in part on your field based activities.
Have you clearly defined performance expectations for your sales force?
What does compliant sales behavior look like at the product level? For example, determine both what your sales force can and cannot say with HCPs and HCOs.
Are you using effective learning techniques to convey performance expectations and change behavior?
In order to change behavior you need more than PowerPoint slides. Use live training, workshop realistic scenarios, provide opportunities for practice and feedback, and involve sales leaders so they can model expectations (or "walk the talk"). Plan for follow up training or scheduled discussions, and create sustainability tools to reinforce the learning.
Are you monitoring behavior in the field?
Reinforce your training by "inspecting what you expect." Incorporate compliance monitoring into scheduled field rides to make it a regular part of doing business.
Are you looking at structured and unstructured data?
Mary Riordan at the OIG recommends the use of "creative auditing" to look at all the ways you interact with customers (i.e., call notes, physician requests for information, and interactions with physician-owned distributorships for anti-kickback violations). Expect the government to use different sources of data to attempt to "connect the dots" in any investigations they conduct.
Are you monitoring business planning activities?
For example, if you record business plans with free text, who is responsible for reviewing these and what is the follow-up procedure to close the loop? Monitoring business plans is also a good way to proactively address potentially risky activities.
Do you have effective reporting procedures?
Your reporting should enable you to monitor trends and require follow-up to close the loop on potential compliance issues. Reporting should also be distributed to everyone who is required to "certify" that sales behavior is compliant, so they can do so with confidence.
Is there local ownership for compliant behavior?
Is it the exclusive responsibility of compliance to ensure compliant behavior, or are sales leaders a partner in monitoring and follow-up activities? All levels of the sales organization should be involved in reinforcing compliant behavioral expectations to ensure a culture of compliance.
Please feel free to contact WLH Consulting, Inc. for more information about how you can assess and improve your field based monitoring procedures. You may also call us to arrange for a demonstration of the I GLASS Field Based Monitoring ProgramŽ.
Wendy Heckelman, Ph.D.
WLH Consulting, Inc.