Use V70.7 for Routine Cost of Clinical Trials
Practioners and suppliers no longer need to differentiate between diagnostic and therapeutic clinical trial services on claims processed after July 10, according to the Centers for Medicare & Medicaid Services (CMS). For proper reimbursement, however, they need to follow recently changed Medicare Claims Processing Manual instructions to the letter.
For claims with dates of service (DOS) before Jan. 1, 2008, report routine costs with HCPCS Level II modifier QV Item or service provided as routine care in a Medicare qualifying clinical trial and code V70.7 Examination of participant in clinical trial as the secondary diagnosis. For claims with DOS on or after Jan. 1, report HCPCS Level II modifier Q1 Routine clinical service provided in a clinical research study that is in an approved clinical research study with code V70.7 as the secondary diagnosis.
Diagnosis code V70.7 is ideal for getting your claims through diagnostic and therapeutic clinical trial services edits.
For outpatient clinical trial claims with DOS before Jan. 1, 2008, report condition code 30 with V70.7 and identify lines containing an investigational item/service with HCPCS Level II modifier QA FDA investigational device exemption or QR Item or service provided in a Medicare specified study for DOS before Jan. 1, 2008 or Q0 Investigational clinical service provided in a clinical research study that is in an approved clinical research study for DOS on or after Jan. 1, 2008. Do not bill Medicare outpatient clinical trial services and non-clinical trial services on the same claim.
Read CMS transmittal 1710, CR 6431, issued April 10, for further guidance.