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Avoid These 3 Clinical-Trial Trouble Spots

Make sure patients are on the books
While coding for clinical trials may present multiple obstacles, knowing your toughest coding foes ahead of time can help smooth the process and prevent mistakes and reimbursement loss. Get to know these three stumbling blocks before the next set of trial charts shows up on your desk.
Documentation. The crucial information to remember when coding for clinical trials is that "documentation for these patients must be equal to documentation for all other Medicare beneficiaries," says Jill Kuruc, MHA, CPC, CCS-P, clinical technical editor at Ingenix Inc. in New York. If your facility regularly performs clinical trials, you might want to establish an audit process for these charts - not just for reimbursement reasons, but for compliance purposes, "especially now that the OIG is looking more closely at these services," she says. You'll want to ensure that your paperwork meets the trial guidelines. Otherwise, you may think the services weren't trial-related and code them incorrectly.
Registration. The main difficulties with patient registration for clinical trials tend to be classic scenarios in which the left hand doesn't know what the right hand is doing. Patients don't tell the administrative staff, so the staff registers them as regular patients. Coders then treat them as regular patients, and the fiscal intermediary (FI) receives a bill that isn't correctly coded. The best way to remedy this, Kuruc says, is to make sure your registration staff, billing staff, and research administration are communicating with each other. Establish a system that lets you track your trials patients so you know whom to ask questions at the registration desk.
Budgetary concerns. While FIs will generally cover routine services, researchers tend to perform services that aren't routine without investigating whether the cost of these items/services fits into the funding they have from their grant or clinical trial sponsors. So when you're discussing details with research administration, "This is another important time to be proactive with your research administration departments," Kuruc says. The amount of money the researchers have for extra services is often underestimated, and you don't want your facility stuck paying the difference.

- Published on 2004-01-02