MolDx has a new hereditary cancer testing LCD this summer, which is heavily dependent on two supporting documents, a billing and coding article, AND, a technical assessment worksheet in Excel.
In their place is a composite LCD for all hereditary cancer syndromes, L38972. This basically states that hereditary cancer panels are covered if the patient has a (personal) cancer diagnosis, a "clinical indication" for germline testing, a "risk factor" for inherited cancer, the test has completed a MolDx TA, and in particular:
- The test performed includes at least the minimum genetic content (genes or genetic variants) with definitive or well-established guidelines-based evidence required for clinical decision making for its intended use that can be reasonably detected by the test.
- Because these genes and variants will change as the literature and drug indications evolve, they are listed separately in associated documents, such as the MolDX® TA forms.
- TIP: NCD 90.2 defines what is a CMS "clinical indication" and "risk factor" which I can never remember without looking it up (more here). A risk factor is "not a clinical condition" (e.g. age is a risk factor, and so is family history) but a clinical indication is something "clinical" like a medical sign, symptom, or test result. The LCD requires a personal history of cancer, AND a clinical indication (not listed) AND a clinical risk factor (not listed); but the NCD directly defines a personal history of cancer as already being a clinical indication (previous link).