Question: Do we need to submit a TA for each single gene assay or sub-panel that is done as part of a larger hotspot panel, but with masking of the other genes?
Answer: The TA must show that the test for which a claim is being submitted was validated. If the test was validated as part of the validation of a larger panel or platform validation, that is fine. If you wish to offer tests to patients consisting of single genes or small groups of genes from a large panel and submit claims for these tests, we ask that you register each gene or group of genes (i.e. each test) with a unique Z-identifier and note on the TA which tests are included in the TA being submitted. This should be done on a cover sheet addressing the validation and its subpanels, as well as the indicated uses for each subpanel.
Question: Can we start submitting TA documentation before the draft Local Coverage Determination (LCD) document is approved?
Answer: Yes, and we would welcome this.
Question: If coverage is not approved by October 1st, can we continue testing?
Answer: Yes. Coverage will only be terminated at that date for providers who do not submit the TA forms. However, if after review, it is found that the test does not meet the requirements of the technical assessment process, then coverage may be terminated.
Question: Are TAs required for all NGS tests?
Answer: All NGS tests on human DNA or RNA will require a Technical Assessment. The LCD has not yet finalized and may change, but at present it pertains to NGS tests that have either an intended use for patients with known cancer or for patients with a possible diagnosis of cancer. We anticipate that most tests unrelated to cancer will require LCDs for coverage.