Wiki Clinical Trial and Oral Medications

[trarut]

Hello, everyone! A question for those of you who work with clinical trials. In instances where the study drug is an oral medication and the patient has Medicare, how do you report that it's a clinical trial service when billing Part D? Do you still use the Q1 modifier and Z00.6 diagnosis code? Is it even necessary to make the distinction?

We are a physician practice with a retail pharmacy and we have the physician billing for clinical trial under control. Our Clinical Research Manager came to me today with the pharmacy question and I can't seem to find a definite answer.

Thanks in advance,
Tracy