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 plans may choose the networks of providers available to enrollees and may require enrollees 
to obtain authorization before receiving services. You can find this rule at 42 CFR Section 422.112(a) and in 
the Centers for Medicare and Medicaid Services, Internet Only Manual, Publication 100-16, Medicare 
Managed Care Manual, Chapter 1, Section 20.2. 
 
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 
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. 
 
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. The Plan 
contract says that, with limited exceptions, members of the Plan must use network providers to get medical care 
and services. The only exceptions are emergencies, urgently needed care when the network is not available 
(generally, when the enrollee is out of the area), out-of-area dialysis services, and cases in which the Plan 
authorizes the use of out-of-network providers. You can find this information on page 46 of the Plan's 2021 
Evidence of Coverage.