Appeal type: unknown
Decision: unknown

 
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 medically necessary services are those that are reasonable and necessary for the diagnosis or 
treatment of an illness or injury. Medically necessary services include services to improve the functioning of a 
malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). 
 
The rules say that services that are not medically necessary are not covered. The rules also say that 
experimental and investigational devices are not covered. You can find this rule at 42 CFR Sections 411.15 and 
411.15(o). 
 
The rules say that coverage will continue on a case by case basis utilizing the following criteria until such time 
a more comprehensive non-proprietary local coverage determination can be developed. 
 
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 patients 
cancer, or has an NCCN 1 or NCCN 2A recommendation for that patients 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 information in the Local Coverage Article (LCA): Billing and Coding: GUARDANT360 
(A58912). 
 
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.