About this policy
Jurisdiction: JM Part B. States: North Carolina, South Carolina, Virginia, West Virginia. Type: Active LCD
Coverage indications
This contractor will cover molecular diagnostic tests for use in a beneficiary with bladder cancer when all of the following conditions are met: The beneficiary is being actively managed for bladder cancer. The beneficiary is within the population and has the indication for which the test was developed and is covered. The laboratory will make available the appropriate indications of the test to the treating/ordering physician. At least 1 of the 2 criteria are met: The patient is a candidate for multiple potential treatments, which could be considered to have varied or increasing levels of intensity based on a consensus guideline, and the physician and patient must decide among these treatments. OR The patient is a candidate for multiple therapies, and the test has shown that it predicts response to a specific therapy among accepted therapy options based on nationally recognized society consensus guidelines (i.e., National Comprehensive Cancer Network [NCCN], American Society of Clinical Oncology [ASCO], Society of Urologic Oncology [SUO], or American Urological Association [AUA]). If Next-Generation Sequencing (NGS) methodology is used in testing, the conditions set by NCD 90.2 are fulfilled (summarized: the patient has advanced cancer; plans on being treated for said cancer, and has not been previously tested with the same test for the same genetic content) The test demonstrates analytical validity including both analytical and clinical validations. If the test relies on an algorithm (which may range in complexity from a threshold determination of a single numeric value to a complex mathematical or computational function), the algorithm must be validated in a cohort that is not a development cohort for the algorithm. The test has demonstrated clinical validity and utility , establishing a clear and significant biological/molecular basis for stratifying patients and subsequently selecting (either positively or negatively) a clinical management decision (in 4. above) in a clearly defined population. The test successfully completes a Molecular Diagnostic Services Program (MolDX ® ) technical assessment that ensures the test is reasonable and necessary as described above. Only 1 test may be performed prior to the initiation of therapy UNLESS a second test that interrogates different genomic content AND meets all the criteria established herein, is reasonable and necessary. The genomic content interrogated by the test must be relevant to the therapy under consideration.
Codes in this policy
Code numbers and each code’s status as the policy records it. CPT code descriptions are left out of this page, as are the passages that cite CPT codes; the official document has them.
| Code | Code system | Status in this policy |
|---|---|---|
| 81401 | CPT | Covered |
| 81403 | CPT | Covered |
| 81404 | CPT | Covered |
| 81445 | CPT | Covered |
| 81479 | CPT | Covered |
| 0016M | HCPCS | Covered |
| C67.0 | ICD10CM | Covered |
| C67.1 | ICD10CM | Covered |
| C67.2 | ICD10CM | Covered |
| C67.3 | ICD10CM | Covered |
| C67.4 | ICD10CM | Covered |
| C67.5 | ICD10CM | Covered |
| C67.6 | ICD10CM |