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 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: 
 
1. Patient has: 
? either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and, 
? either not been previously tested using the same NGS test for the same primary diagnosis of cancer, or 
repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the 
treating physician; and, 
? decided to seek further cancer treatment (e.g., therapeutic chemotherapy). 
2. The diagnostic laboratory test using NGS must have: 
? Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic; and, 
? an FDA-approved or -cleared indication for use in that patient?s cancer; and, 
? results provided to the treating physician for management of the patient using a report template to 
specify treatment options. 
You can find these rules in National Coverage Determination (NCD) Next Generation Sequencing (NGS) 
(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 unless 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. 
You can find this rule in the Local Coverage Article: Guardant 360 and Prospera (A58190) effective May 15, 
2020. 
  
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.