Clinical Trials Routine Care Services Diagnosis Coding Instructions

Original Effective Date:12/06/2001
Revision Effective Date: 11/01/2013

Effective for dates of service on or after January 1, 2002, providers must use the procedure code modifier "QV" to identify and report routine care for Medicare qualifying clinical trial services. The use of the "QV" modifier serves as the provider's attestation that a service, supply or equipment meets the Medicare qualifying coverage criteria for clinical trial services. In addition, the reporting of diagnosis code V70.5 as a secondary diagnosis will no longer be required as of this date.

One exception to this billing requirement is for items or services rendered on or after January 1, 2002, to healthy, control group volunteers as part of a qualifying diagnostic clinical trial. Routine care of healthy, control group, volunteers enrolled in a qualifying diagnostic clinical trial must be coded and billed in the following manner:

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

Only claims utilizing the "QV" modifier and the diagnosis code V70.7 as the primary diagnosis will be considered as services or items rendered to healthy, control group, diagnostic trial volunteers.

Providers submitting claims for routine items and services furnished to beneficiaries in qualifying clinical trials should include information in the beneficiary's medical record about the clinical trial such as: the trial name, sponsor and sponsor-assigned protocol number. This information should not be routinely submitted with the claim but should be provided upon request for medical review. A copy of routine items and services provided should also be maintained and provided to medical review upon request.

            Last Updated Fri, 05 May 2017 14:20:01 +0000