HCPCS Modifier Q1

• In order for a service to be covered under Medicare as routine care in a Medicare qualifying clinical trial, the clinical trial must meet CMS requirements
• Routine services that are associated with a qualifying clinical trial may be covered by Medicare
• Routine clinical services are defined as those items or services that are covered for Medicare beneficiaries outside of the clinical research study; are used for the direct patient management within the study; and do not meet the definition of investigational clinical services
• These services may include:
  • Items or services required solely for the provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent), clinically appropriate monitoring, whether or not required by the investigational clinical service (e.g., blood tests to measure tumor markers)
  • Items or services required for the prevention, diagnosis or treatment of research related adverse effects (e.g., blood levels of various parameters to measure kidney function)

Exceptions

• The investigational item or service itself unless it is a qualifying Category B IDE device. The Category B IDE device would be reimbursed under Medicare Part A or the Medicare Part B Durable Medical Equipment (DME) benefit.
• Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan)
• Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial
• Submit these services with HCPCS modifier Q1, regardless of whether the services were provided to a patient in the experimental or control arm of the clinical trial. The patient's medical record must include the trial name, sponsor and sponsor-assigned protocol number.
• If the services were provided to a patient in the control arm of the clinical trial, submit ICD-9 code V70.7 or ICD-10 code Z006 as the primary or secondary diagnosis (per IOM Pub. 100-4, Ch. 32, Sec. 68.3 & 69.6)
• If the routine 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 Q1. 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.