Modifier Q1 Routine clinical service provided in a clinical research study that is in an approved clinical research study
Correct Use
When a routine clinical service is performed 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
Used for direct patient management within the study
Does not meet 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 investigational clinical service (e.g., blood tests to measure tumor markers) and items or services required for prevention, diagnosis, or treatment of research related adverse events (e.g., blood levels of various parameters to measure kidney function)
Incorrect Use
When service is not part of an approved clinical research study
Modifier Q0 Investigational clinical service provided in a clinical research study that is in an approved clinical research study
Correct Use
When an investigational service is performed 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 study
Investigational clinical services may include items or services that are approved, unapproved or otherwise covered (or not covered) under Medicare
Incorrect Use
When service is not part of an approved clinical research study
When service is not investigative in nature
Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for Solid Tumors (This
Change Request (CR) rescinds and fully replaces MM 846
This article is based on Change Request (CR) 8739, which advises MACs, effective for dates of service on or after June 11, 2013, to cover three FDG PET scans when used to guide subsequent management of anti-tumor treatment strategy after completion of initial anti-cancer therapy for the same cancer diagnosis. Coverage of any additional FDG PET scans (that is, beyond three) used to guide subsequent management of anti-tumor treatment strategy after completion of initial anti-cancer therapy for the same diagnosis will be determined by your MAC.
Effective for claims with dates of service on or after June 11, 2013, Medicare will accept and pay for FDG PET oncologic claims billed to inform initial treatment strategy or subsequent treatment trategy for suspected or biopsy proven solid tumors for all oncologic conditions without requiring the following:
• Q0 modifier: Investigational clinical service provided in a clinical research study that is in an approved clinical research study (institutional claims only);
• Q1 modifier: routine clinical service provided in a clinical research study that is in an approved clinical research study (institutional claims only);
• V70.7: Examination of participant in clinical research;or
• Condition code 30 (institutional claims only).
Effective for dates of service on or after June 11, 2013, MACs will use the following messages when denying claims in excess of three for PET FDG scans for subsequent treatment strategy when the
–KX modifier is not included, identified by Procedure codes 78608, 78811, 78812, 78813, 78814, 78815, or 78816, modifier –PS, HCPCS A9552, and the same cancer diagnosis code:
• Claim Adjustment Reason Code (CARC) 96: “Non-Covered Charge(s). Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present.”
• Remittance Advice Remarks Code (RARC) N435: “Exceeds number/frequency approved/allowed within time period without support documentation.”
• Group Code PR assigning financial liability to the beneficiary, if a claim is received with a GA modifier indicating a signed ABN is on file.
• Group Code CO assigning financial liability to the provider, if a claim is received with a GZ modifier indicating no signed ABN is on file.
MACs will not search their files to adjust claims processed prior to implementation of CR8739.
However, if you have such claims and bring them to the attention of your MAC, the MAC will
adjust such claims if appropriate.
Synopsis of Coverage of FDG PET for Oncologic Conditions
Effective for claims with dates of service on and after June 11, 2013, the chart below summarizes national FDG PET coverage for oncologic conditions:
FDG PET for Cancers Tumor Type |
Initial Treatment Strategy (formerly “diagnosis” & “staging” |
Subsequent Treatment Strategy (formerly “restaging” & “monitoring response to treatment” |
Colorectal | Cover | Cover |
Esophagus | Cover | Cover |
Head and Neck (not thyroid, CNS) |
Cover | Cover |
Lymphoma | Cover | Cover |
Non – small cell lung |
Cover | Cover |
Ovary | Cover | Cover |
Brain | Cover | Cover |
Cervix | Cover with execptions* | Cover |
Small cell lung | Cover | Cover |
Soft tissue sarcoma | Cover | Cover |
Pancreas | Cover | Cover |
Testes | Cover | Cover |
Prostate | Non-Cover | Cover |
Thyroid | Cover | Cover |
Breast (male and female) | Cover with execptions* | Cover |
Melanoma | Cover | Cover |
All other solid tumors | Cover | Cover |
Myeloma | Cover | Cover |
All other cancers not listed | Cover | Cover |
*Cervix: Nationally non-covered for the initial diagnosis of cervical cancerrelated to initial anti-tumor treatment strategy. All other indications for initial anti-tumor treatment strategy for cervical cancer are nationally covered.
* Breast: Nationally non-covered for initial diagnosis and/or staging of axillarylymph nodes. Nationally covered for initial staging of metastatic disease. All other indications for initial anti-tumor treatment strategy for breast cancer are nationally covered.
*Melanoma: Nationally non-covered for initial staging of regional lymphnodes. All other indications
For initial anti-tumor treatment strategy for melanoma are nationally covered.