Description
Investigational clinical service provided in a clinical research study that is in an approved clinical research study.

Guidelines/Instructions
  • Investigational clinical services are defined as those items and services that are being investigated as an objective within the study. Investigational clinical services may include items or services that are approved, unapproved or otherwise covered (or not covered) under Medicare.
  • This modifier replaces HCPCS modifiers QA and QR
  • If the "investigational clinical services" are associated with a clinical trial involving a Category A or B IDE device, the IDE number is also required on the claim. Charges for a Category A IDE device itself are not covered. Charges for a Category B IDE device may be considered for coverage.
    • Paper claim submitters: Submit the IDE number in Item 23 of the CMS-1500 claim form
    • Electronic claim submitters: Submit the IDE number in Loop 2300 REF02 (REF01=LX)
    • Palmetto GBA will validate the IDE number when it is submitted on claims that contain HCPCS modifier Q0. Claims containing invalid IDE numbers will be returned as unprocessable with remark code MA130. These claims must be corrected and resubmitted as new claims.
  • The clinical trial registry number should be preceded by the two alpha characters of "CT" and placed in Field 19 of the paper CMS-1500 claim form or for electronic claims, it should be entered without the "CT" prefix in Loop 2300 REF02 (REF01=P4)

Reference: CMS website – IOM Pub 100-4, Chapter 32, Sections 68, 69, and IOM Pub 100-3, NCD 310.

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