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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:

  1. 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.
  2. Approved IDE number, as listed on your approval letter.
    1. Electronic claims: Loop 2300 in ref segment with an LX qualifier
    2. Paper claims: Item 19
  3. 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”.
    1. Electronic claims: Loop 2300 REF02(REF01=P4)
    2. 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 ClaimsExternal PDF.”

Additional information is available in the Clinical Trials section of the CGS website for Part A and Part B

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