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Follow-up on compliance training

Device Regulation Alert: Safety, Compliance and Reimbursement News, August 3, 2007

In our final installment regarding compliance training for medical device representatives, we explain how to make sure your training works. Here's how to monitor and audit staff conduct to ensure they follow your compliance policies.

Staff accountability
Training your company's representatives on what is and isn't ok to do with regard to medical education of providers, pricing, gifts to providers, and grant activities, isn't enough to keep your company out of compliance trouble.

Require justification of sales and marketing representatives' expenses. Hold staff accountable. Give them checklists and documentation of what they should and shouldn't promise, or give, to healthcare professionals who order, use, or prescribe your devices, says attorney Neil B. Caesar, of The Health Law Center in Greenville, SC. Do not rely on their good intentions and recollection skills.

Institute documentation requirements such as expense requests, requiring approval for specific types of sales offers and other operational details that enable management to examine sale staff's activities, Caesar explains.

Put in a system of checks and balances for expense reporting and reimbursement, agrees healthcare attorney Michael Manthei, a partner in the Boston office of Holland & Knight LLP. For example, require approval for any expenses over a specific amount, he says.

Audit conduct
Auditing represents one of the most important of all your compliance efforts. Don't rely on complaints to reveal problems. And don't just make your representatives keep good records-check those records.

"You have to audit expense reports," says Manthei. Require approval of expenses which exceed a set amount. Such simple processes help flag unusual reimbursement requests, he adds.

Also perform random audits of expense reports, group purchasing contracts, and supplier distribution agreements, says Manthei. And don't forget independent, contracted sales staff not directly employed by your company, he adds. Having an independent entity involved doesn't provide a buffer from liability for compliance mishaps, particularly if the contracted entity acts as your agent, he says.

If you do get in trouble, and end up with a Corporate Integrity Agreement (CIA), the government requires you to hire an expensive outside auditor. Before this happens, look to the CIA audit standards and crib from those guidance to create your own auditing plans, suggests Manthei.

All CIAs are available on the Department of Health and Human Services, Office of Inspector General Website (www.oig.hhs.gov)

Your corporate compliance program, especially your auditing efforts, protects the overall company from criminal implications It not only helps prevent violations from occurring in the first place, but also shows that the company is a good corporate citizen so that if rules are broken, it's not the company and its shareholders who suffer, advises Manthei.

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