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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101.
The rules say that effective for services performed on or after March 16, 2018, the Centers for Medicare & Medicaid Services (CMS) has determined that Next Generation Sequencing (NGS) as a diagnostic laboratory test is reasonable and necessary and covered nationally, when performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, when ordered by a treating physician, and when all of the following requirements are met:
a. Patient has:
i.either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and
ii.not been previously tested with the same test using NGS for the same cancer genetic content, and
iii.decided to seek further cancer treatment (e.g., therapeutic chemotherapy).
b. The diagnostic laboratory test using NGS must have:
i.Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic; and,
ii.an FDA-approved or -cleared indication for use in that patient's cancer; and,
iii.results provided to the treating physician for management of the patient using a report template to specify treatment options.
You can find this rule in the Centers for Medicare and Medicaid Services, Internet Only Manual, Publication 100-03, Medicare National Coverage Determination for Next Generation Sequencing, 90.2.
The rules say that Guardant360 remains covered for patients with non-CNS originated solid tumors who meet the criteria of NCD 90.2 when the following conditions are met:
Patient has been diagnosed with a recurrent, relapsed, refractory, metastatic, or advanced solid tumor that did not originate from the central nervous system. Patients who would meet all of the indications on the FDA label for larotrectinib if they are found to have an NTRK mutation may be considered to have advanced cancer, and
- Patient has not previously been tested with the Guardant360 test for the same primary cancer. For a patient who has been tested previously using Guardant360 for a cancer, that patient may only be tested again when the patient has a new primary cancer diagnosis.
In a patient with previously tested primary cancer, who has evidence of new malignant growth, that growth may be considered to be a different primary cancer if it does not originate from the same cell line or it is physiologically different enough that it responds differently to treatment than the previously tested cancer, and
- Patient is untreated for the primary cancer being tested or the patient is not responding to treatment (e.g. progression or new lesions on treatment), and
- The patient has decided to seek further cancer treatment with the following conditions:
- The patient is a candidate for further treatment with a drug that is either FDA-approved for that patient's cancer, or has an NCCN 1 or NCCN 2A recommendation for that patient's cancer, and
- The FDA-approved indication or NCCN recommendation is based upon information about the presence or absence of a genetic biomarker tested for in the Guardant360 assay, and
- Tissue-based CGP is infeasible (i.e., quantity not sufficient for tissue-based CGP or invasive biopsy is medically contraindicated) or specifically in NSLC Tissue-based CGP has shown no actionable mutations.
If no alteration is detected by Guardant360 or if ctDNA is insufficient/not detected, tissue-based genotyping should be considered. You can find this rule in the Local Coverage Article for Billing and Coding: Guardant360, A58192 (eff 05/15/20).
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.