MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules

Summary of Evidence Analysis of Evidence General Information Associated Information Sources of Information Bibliography Revision History Information Associated Documents Attachments Related Local Coverage Documents Related National Coverage Documents Public Versions Keywords Local Coverage Determination (LCD) MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules L39646 Expand All | Collapse All  Email Document  Download  Add to basket Contractor Information Contractor Name Contract Type Contract Number Jurisdiction States LCD Information Document Information LCD ID L39646 LCD Title MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules Proposed LCD in Comment Period N/A Source Proposed LCD DL39646 Original Effective Date For services performed on or after 07/28/2024 Revision Effective Date For services performed on or after 03/13/2025 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 06/13/2024 Notice Period End Date 07/27/2024 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relati

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.