Routine Cost of Clinical Trials

CMS has decided there is no longer a need to distinguish between diagnostic and therapeutic clinical trial services. This decision by CMS goes into effect July 10, 2009 and applies to all claims submitted with dates of service on or after January 1, 2008. The ICD-9 diagnosis code of V70.7 is still required to be reported on all claims that were submitted with either the QV or Q1 modifier. In addition to condition code 30 and a secondary diagnosis code of V70.7, all outpatient claims must identify all lines that contain an investigational item/service and all lines that contain routine services. When identifying the investigational items/services, modifiers QA or QR are required for services provided before January 1, 2008 and Q0 should be reported for services on or after January 1, 2008. Routine services provided before January 1, 2008 should be reported with a QV modifier and routine services provided on or after January 1, 2008 should be reported with a Q1 modifier. After the implementation of this decision, clinical trial claims submitted with either modifier QV or Q1 will be returned to a provider as unprocessable if the diagnosis code of V70.7 is not reported on the claim.

CCH Chicago Bureau