MolDx has released a new and very different LCD for cancer germline testing. These are LCD L38966 and billing article A58652.
The LCD simply states that the patient must have a cancer, and a clinical indication for testing, and a risk factor for testing.
The LCD, and the article, do NOT give any specific authoritative guidelines. This will surprise readers who are used to a list of an LCD's complex rules for cancer testing such as a headcount of first degree relatives, or a history of Ashkenazi heritage, or a dozen other rules.
What are Clinical Indication and Risk Factor?
NCD 90.2 was revised in 2020 to include hereditary NGS panels. The decision summary of the NCD is brief: a patient must have "any cancer diagnosis, a clinical indication for testing, a risk factor for testing." This is the same brief text as the new LCD.
But, the narrative analysis for the NCD provides definitions. In fact, CMS remarked that one of the main revisions in the "final" hereditary LCD was to define for the reader, what they meant by clinical indications and risk factors.
https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=296
There, we read,
Clinical indications are different from risk factors. A RISK FACTOR is a variable associated with INCREASED RISK (such as age, gender, family history) absent signs and symptoms.
A CLINICAL INDICATION, is a sign, symptom, or test result, or medical condition, that leads to a recommendation for a test.
RISK MODELS may use both risk factors (age) and clinical indications [to estimate a risk value]. For example, the FRAX fracture calculator uses age and sex which are generic factors and not considered illnesses or medical conditions, but also measured bone density or T score which is a medical sign or test result.)
Later in the NCD, lest there be any doubt, CMS states that "clinical indications (can be) a personal history of breast cancer or ovarian cancer." This is important because it makes, at least sometimes, the two separate bullet points redundant. (If "personal history cancer" can checkmark the other box, "clinical indication.")
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While the MolDx LCD and Article don't name any guidelines, that I can see, we can refer to ABSA and the newest CRC version for NCCN. Age > 65 is a risk factor, and a "sign or symptom" is having cancer.
