Life Sciences

Compliance officer: Managing KOLs across departments is ’critical’

Pharma Compliance Alert, August 30, 2006

Keeping track of your company's relationships with KOLs is critical, not only within departments, but across the entire organization. If several departments are contracting with--and paying--the same KOL, the pharma could unintentionally go over payment caps for that physician.

"The caps and the reporting requirements apply to the company, not to its individual departments," Bert Johnson, Kyphon's chief compliance officer, tells Pharma Compliance Alert. "Government authorities will likely be wholly unconcerned with internal organization when they come knocking at your door."

Mark DuVal, director of the law firm DuVal & Associates, agrees. "You've got reps, you've got marketers, and medical education professionals, and everybody has to find a way to report this stuff in."

Contracting with members of formulary committees may cause another problem. Since Part D compliance rules require at least one physician committee member to be free of conflict of interest, pharmas must monitor their KOL relationships to ensure that they're not contracting with an entire committee.

According to Bert Johnson, pharmas and device companies need to implement controls for tracking aggregate spend. He offers the following tips:

  • Establish one company-wide accounting and expense reporting system with adequate data entry criteria designed to facilitate tracking and auditing of all consultant remuneration.

  • Require all consultant agreements to be in writing, stored in one document management system, and approved by one centralized department, such as Legal or Compliance.

  • Place one centralized department in charge of conducting periodic audits. This responsibility may go to Legal, Compliance, or Finance.

    Pharmas may also work with outside firms that offer database solutions. For example, technology-driven pharma events firm Advanced Health Media provides centralized tools to track and manage all physician interactions.

    Such tools should compile all relevant physician data in one place in order to manage and plan current and upcoming interactions, according to Jeff Brady, the company's president. If everyone in the company uses the same system, all healthcare provider interactions will be funneled through it, enabling compliant meetings and interactions across the organization-what Brady refers to as "proactive compliance."

    A platform from KOL relationship management firm openQ is another example. The tool, KOL Manager V2.5, helps companies achieve what openQ President and Founder Jim Zuffoletti calls "lifecycle management." It manages KOL interactions throughout a company by coordinating activities and using tools that help departments work with KOLs that are right for a particular activity. The platform uses 11 modules that are customizable to the company. For example, modules can help identify promising new KOLs, resolve scheduling conflicts, and compare a company's KOLs against other top KOLs in the market.

    Whatever solution the organization chooses, companies cannot afford to be negligent in their compliance.

    "It is absolutely critical for pharma and device companies to monitor across silos for KOL management," Johnson says. "I don't think it's possible to be too careful here."

    • Most Popular

    Related Articles