Moldx and "patients without cancer"

The MRD TA form at MOLDX inquires about presurgical patients and post surgical patients.  Post surgical patients are divided into those with cancer and those without cancer.   How does it define the latter?

Not on the TA form.   

Go to the LCD itself, as MolDx explains below.

• As per L38779, a patient without cancer is a patient with “no clinical, radiographical, or other biological evidence that tumor cells remain post treatment and subsequently the patient is no longer being subjected to therapeutic interventions for cancer.”
• If treatment is ongoing, then the patient is considered to still have cancer. So, a patient who had a lumpectomy is considered to be “without cancer” IF the above statement is true - for example, she is also not undergoing radiation or other treatments and there is no evidence that cancer cells exist (i.e. margins and scans are negative, etc.).

MolDx defines e.g. postsurgical adjuvant radiation or chemo as "treatment for cancer" but a 5 or 10 year treatment with e.g. tamoxifen is NOT considered a treatment for cancer.

If the patient qualifies as treatment for cancer period, then MRD testing would be either one time testing, or, in some cases, a series of several assays defined as one test.   If the patient qualifies as POST cancer, NO cancer, as above, then MRD tests can be billed individually as it is a "patient without cancer."   (This paragraph is inference to the one-test-per-patient clause in NCD 90.2)

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