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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 providers must report services correctly. Procedures should be reported with the Current Procedural Terminology (CPT) code that describes the services performed. You can find this rule in the Centers for Medicare and Medicaid Services, Medicare National Correct Coding Initiative Policy Manual for Medicare Services, Chapter I(A).

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
for larotrectinib if they are found to have an NTRK mutation may be considered to have advanced cancer, and
&#8722; 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
&#8722; 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
&#8722; The patient has decided to seek further cancer treatment with the following conditions:
&#8722; 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
&#8722; 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
&#8722; 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.
&#8722; CPT/HCPCS code 81479

You can find this rule in the Local Coverage Article for Billing and Coding: Guardant360, A58192 (eff 05/15/20).

The rules say that if one laboratory procedure evaluates multiple genes using a next generation sequencing procedure, the lab shall report only one unit of service of one genomic sequencing procedure, molecular multianalyte assay, multianalyte assay with algorithmic analysis, or proprietary laboratory analysis CPT code. If no CPT code accurately describes the procedure performed, the lab may report CPT code 81479 with one unit of service. If a single procedure is performed, only one HCPCS/CPT code with one unit of service may be reported for the procedure. You can find this rule in the Centers for Medicare and Medicaid Services, Medicare National Correct Coding Initiative Manual, Chapter X(F).

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.