Revised Diagnosis Reporting Requirements for Routine Care Clinical Trial Services

Original Effective Date: 10/01/2001
Revision Effective Date: 11/01/2013

Effective for services furnished on or after January 1, 2002, billers will use procedure code modifier "QV" to identify and report routine care for Medicare qualifying clinical trial services. The reporting of diagnosis code V70.5 as a secondary diagnosis on Form HCFA-1500 or the electronic claim equivalent will no longer be required for dates of service on or after January 1, 2002. For dates of service on or after January 1, 2002, the QV modifier constitutes the biller's attestation that a service, supply or equipment meets the Medicare qualifying coverage criteria for clinical trial services processed by carriers and DMERCs.

EXCEPTION: Routine care clinical trial services furnished on or after January 1, 2002, to healthy, control group volunteers participating in Medicare qualifying diagnostic clinical trials are to be coded and billed in the following manner:

  • The "QV" procedure code modifier is reported at the line item level.
  • Diagnosis code V70.7 (Examination of participant in clinical trial) is reported as the primary diagnosis for applicable line items on the Form HCFA-1500 or electronic claim equivalent.

If diagnosis code V70.7 is reported as a secondary rather than the primary diagnosis the service/item will not be considered as having been furnished to a healthy, control group, diagnostic trial volunteer.

            Last Updated Thu, 11 May 2017 11:12:22 +0000