Billing for Routine Clinical Research Services

by Janine G. Jacobs, CPA, CPC, CCS
The area of clinical research has certain reimbursement nuances that can be very confusing to the average coding and billing staff. Understanding the rules surrounding clinical research billing is imperative from a compliance perspective. It takes the expertise on the part of the clinicians, coders and billers to properly segregate the charges that are exclusive to a clinical trial. Once those charges are segregated, the appropriate modifiers and ICD-9 codes must be applied in order to properly process the claims.
Beginning in September 2000, payments were authorized for services rendered to patients participating in a qualifying clinical trial. Payments are made in accordance with the specific payment methodology for that particular item or service: fee schedule, reasonable cost, etc. The following guidelines apply to billing for routine costs which are provided during a clinical research study that are not covered by the sponsor and are billable to Medicare. Typically, private insurances follow Medicare guidelines; however, it is important to check with each insurance carrier to determine eligibility, billing requirements, etc. For the purposes of this discussion, we will focus on Medicare guidelines.
Whether through a manual bill hold process or through automated segregation of charges within one or more IT systems, the first and most critical step is to carefully evaluate each line item charge to determine whether it is billable to the sponsor or to Medicare as part of a clinical trial. Study-related charges may be billed on the same claim form as non-study related services provided that they are clearly identified with the appropriate modifiers. A detailed discussion of those modifiers is presented below.
HCPC Modifiers
Effective January 1, 2008 two modifiers were introduced by CMS to specifically differentiate between routine and investigational items/services, as follows:

• Q0 – For an investigational item or service provided during or as part of an approved clinical research study. “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.”[1]
• Q1 – For a routine item or service provided during or as part of an approved clinical research study. “Routine clinical services are defined as those items and 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. Routine clinical services may include items or services required solely for the provision of the investigational clinical services (e.g., administration of a chemotherapeutic agent); clinically appropriate monitoring, whether or not required by the investigational clinical service (e.g., blood tests to measure tumor markers); and items or services required for the prevention, diagnosis, or treatment of research related adverse events (e.g., blood levels of various parameters to measure kidney function).” 1 

The modifiers are applied after the HCPCS codes on a line item basis and are required for all claims submitted for services rendered to patients in clinical research studies.
For Technical Fee Claims

• Submit on UB-04 form or electronic equivalent 837i
• Report V70.7 (Examination of a participant in a clinical trial) as the secondary diagnosis.
• Report condition code 30 (qualifying clinical trial)
• Report the Q0 or Q1 modifier at the line-item level (outpatient claims only)

For Professional Fee Claims

• Submit on CMS 1500 form or electronic equivalent 837p
• Report V70.7 (Examination of a participant in a clinical trial) as the primary diagnosis.
• Report the Q0 or Q1 modifier at the line-item level

When billed in conjunction with the V70.7 ICD-9 code, the Q1 modifier will serve as the provider’s attestation that the service meets the Medicare coverage criteria (i.e., was furnished to a beneficiary who is participating in a Medicare qualifying clinical trial and represents routine patient care, including complications associated with qualifying trial participation.

[1] Pub. 100-04, Transmitttal:1418, January 18, 2008, Change Request:5805 Effective Date January 1, 2008.

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