Answer:
You must ensure, based on the year of your claim, that the appropriate modifiers are present on the claim so that it may process correctly. For outpatient clinical trial claims:

  1. All services on the claim are related to the trial - Institutional providers billing clinical trial claims that contain only clinical trial line item services do not have to report the routine Healthcare Common Procedure Coding System (HCPCS) modifiers QV or Q1. The presence of condition code 30 along with the absence of the QV or Q1 HCPCS modifier is the provider’s attestation that all line item services on the claim are routine clinical trial services with the exception of any investigational item on the claim that would be identified with a Q0 HCPCS modifier on or after January 1, 2008, or a QA modifier before January 1, 2008.
  2. Claim contains both services related and unrelated to the trial - Institutional providers billing clinical trial claims that contain both clinical trial line item services and non-clinical trial line item services, must bill the following elements:
    1. Claims with dates of service on or after January 1, 2008:
      HCPCS modifier Q1 only on line items related to the clinical trial and diagnosis code V70.7 (examination of participant in clinical trial) reported as the secondary diagnosis and condition code 30.

Reference:

Contact Palmetto GBA JJ Part A Medicare

Provider Contact Center: 877-567-7271

Email JJ Part A

Contact a specific JJ Part A department


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