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August 25, 2015

Clinical Trial Identifier and Investigation Device Exemption (IDE) Claim Submissions

This article is related to the mandatory reporting of a clinical trial identifier numbers on claims for items and services provided in clinical trials that are qualified for coverage as specified in the "Medicare National Coverage Determination (NCD) Manual," Section 310.1.External PDF

Recently CGS is seeing an increase in claim denials for missing or incorrect information. The following guidelines MUST be followed in order to allow claims for payment:

  1. Sponsor must obtain CMS approval
  2. Local approval must be obtained by CGS
  3. The IDE number must be included on each claim. The IDE Number is listed on your approval letter. The below applies to both Institutional and Professional claims.
    1. The 7-digit alpha numeric IDE number should be placed in REF02 (REF01=LX)
  4. 8 Digit NCT Registry Number must be on the claim as follows:
    1. For institutional claims that are submitted on the electronic claim 837I, the 8-digit number should be placed in Loop 2300 REF02 (REF01=P4) when a clinical trial claim includes:
      1. Condition code 30;
      2. ICD-9 code of V70.7/ICD-10 code Z00.6 (in either the primary or secondary positions) and
      3. Modifier Q0 and/or Q1, as appropriate (outpatient claims only).
    2. For professional claims:
      1. For electronic claims the 8-digit clinical trial number is listed as; the electronic equivalent 837P in Loop 2300 REF02(REF01=P4) (do not use CT on the electronic claim, e.g., 12345678)
      2. The 8-digit clinical trial number preceded by the 2 alpha characters of CT (use CT only on paper claims) must be placed in Field 19 of the paper claim Form CMS-1500 (e.g., CT12345678) or
      3. when a clinical trial claim includes:
        • ICD-9 code of V70.7/ICD-10 code Z00.6 (in either the primary or secondary positions) and
        • Modifier Q0 and/or Q1, as appropriate (outpatient claims only).

NOTE: The IDE Number and NCT Registry number are NOT the same number; please reference your CGS Approval letter for clarification

Reference:

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