July 10, 2014
Clinical Trial Claim Submissions: Reminders
When submitting a claim for services involving a CGS approved Investigational Device Exemption (IDE) Trial, remember to include the following information:
- HCPCS modifier Q0 (second digit is a numeric zero, not the letter “O”) with investigational services performed as part of an approved clinical research study.
- Approved IDE number, as listed on your approval letter.
- Electronic claims: Loop 2300 in ref segment with an LX qualifier
- Paper claims: Item 19
- Clinical trial/registry/study claims with dates of service on or after January 1, 2014 must include the 8-digit clinical trial number, preceded by the alpha characters “CT”.
- Electronic claims: Loop 2300 REF02(REF01=P4)
- Paper claims: Item 19
Claims for clinical trial/registry/study services for dates of service on or after January 1, 2014 that are submitted without the 8-digit clinical trial number and/or the IDE number will be “returned as unprocessable” (rejected) with remark codes MA50 and MA130 and reason code CO-16. These claims must be corrected and resubmitted; appeal rights do not apply.
If the clinical trial number cannot be obtained or is not available, you may report the generic number 99999999 (8-digit number, all 9’s) from January 1 through December 31, 2014. For more details, refer to CMS MLN Matters article SE1344, “Further Information on Mandatory Reporting of an 8-digit Clinical Trial Number on Claims.”
Additional information is available in the Clinical Trials section of the CGS website for Part A and Part B