License for Use of "Physicians' Current Procedural Terminology", (CPT) Fourth Edition

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POINT AND CLICK LICENSE FOR USE OF "CURRENT DENTAL TERMINOLOGY", ("CDT")

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CertNDx Bladder Cancer Assay: Coding and Claim Submission Guidelines

The CertNDx bladder cancer assay test test includes three different types of tests; Hematuria Assessment, Molecular Grading, and Recurrence Monitoring. These tests use a combination of DNA, immunohistochemistry, and protein biomarkers to determine if the patient has cancer, recurrence of cancer, or progression of cancer.

Hematuria assessment is a urine test that looks at the FGFR3, MMP2, TWIST1 and NID2 DNA and protein biomarkers to determine if the patient has urothelial cancer or has the possibility of developing this type of cancer.
Molecular grading is a tissue-based test that provides a method of grading bladder tumors and gives insight into which tumors are likely to be progressive by reviewing the FGFR3 and Ki-6 immunohistochemistry and DNA.
Recurrence monitoring is a urine test used to help determine if a patient with a past history of bladder cancer runs the risk of developing this type of cancer again. This test uses a combination of the FGFR3, MMP2, Vimentin, and NID2 DNA and protein biomarkers.

CGS has determined that these CertNDX CertNDx tests does not support the clinical utility for themeet the definition of an established Medicare benefit category and is aare statutorily excluded tests. The individual tests should not be billed separately.

Health care providers are not required to submit claims to Medicare for statutorily non-covered services; however, you may choose to submit claims (e.g., at the patient's request). Claims for CertNDx Bladder Assay Tests must include:

For dates of service prior to January 1, 2013: use the appropriate CPT code stack for the test.
For dates of service on or after January 1, 2013: submit CPT code 81479
HCPCS modifier GY (statutorily non-covered service)
The appropriate ICD-9-CM code(s)
The name of the test: (CertNDx Bladder Cancer Assay)
- Electronic claims: Loop 2400, NTE02, or SV101-7 field
- Paper claims: Box 19

Reference:

Definition of "reasonable and medically necessary": Social Security Act, section 1862(a)(1)(A)
Exception to mandatory claim submission for "categorically excluded services": CMS MLN Matters article SE0908, "Mandatory Claims Submission and Its Enforcement"
Guidance on issuing Advance Beneficiary Notices of Noncoverage (ABNs) on a voluntary basis for statutorily excluded services: CMS Beneficiary Notices Initiative Web page – Fee-For-Service (FFS) ABN