Clinical Trials and Modifier QV   A new modifier has been identified to track Medicare participants in clinical trials, QV Medicare Part B began covering routine care costs provided to Medicare participants in clinical trials in September 2000. As of 1/1/02, services submitted to the Medicare program for routine care should be submitted with the modifier QV appended to the line item service. The ICD code, V70.5, health examination of defined subpopulation, is no longer required as a secondary diagnosis code. Detailed information about the clinical trial should be available in the patient medical record and provided to the carrier if requested. This includes: 1. Name of the clinical trial; 2. Sponsor; and 3. Assigned protocol number of the sponsor. Routine care for clinical trial services for healthy control group volunteers should be submitted with the "QV" modifier and the ICD code, V70.7, "examination of participant in a clinical trial" listed as a primary diagnosis.   Return to Contents | Return to Billing Compliance