About this policy
Jurisdiction: J8 MAC Part B. States: Indiana, Michigan. Type: Active LCD
Coverage indications
This contractor will cover molecular diagnostic tests for use in a beneficiary with an indeterminate or suspicious thyroid nodule when all the following criteria are met: The patient: Has an index nodule that has not been tested with the same or similar assay for the same clinical indication AND The nodule is indeterminate as defined by Bethesda categories III-IV OR The nodule is Bethesda category V and molecular testing may aid in further stratifying the type of malignancy. If the patient has multiple nodules, concurrent or reflex testing may be medically necessary, provided the above criteria are also met. The results of the test will be used to aid in surgical decision making after a consideration of clinical, radiographic and cytologic features. The beneficiary is within the population and has the indication for which the test was developed. The laboratory providing the test is responsible for clearly indicating to treating clinicians the population and indication for test use. The test demonstrates analytical validity, including both analytical and clinical validation, on a cohort of patients appropriate for its intended use. If the test relies on an algorithm, 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 in peer-reviewed, published literature, establishing a clear and significant biological/molecular basis for stratifying patients and subsequently selecting (either positively or negatively) a clinical management decision in a clearly defined population. The test successfully completes a technical assessment that ensures the test is reasonable and necessary as described above. The performance characteristics of the test have been demonstrated to be as good or better than currently covered services. NOTE: Next Generation Sequencing (NGS) performed to identify genetic variants in samples classified as malignant is not within the scope of this policy but may fall under other established policies.
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 |
|---|---|---|
| 81479 | CPT | Covered |
| 81546 | CPT | Covered |
| D44.0 | ICD10CM | Covered |
| D44.9 | ICD10CM | Covered |
| E01.0 | ICD10CM | Covered |
| E01.1 | ICD10CM | Covered |
| E01.2 | ICD10CM | Covered |
| E04.0 | ICD10CM | Covered |
| E04.1 | ICD10CM | Covered |
| E04.2 | ICD10CM | Covered |
| E04.8 | ICD10CM | Covered |
| E04.9 | ICD10CM | Covered |