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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 state that Genomic Sequential Analysis Panel will be considered reasonable and necessary in the 
evaluation of tumor tissue in the following clinical circumstances:  
1. Newly diagnosed patients with advanced (stage IIIB or IV) NSCLC, who are not treatable by resection 
or radiation with curative intent, and who are suitable candidates for therapy at the time of testing. 
2. Previously diagnosed patients with advanced (stage IIIB or IV) NSCLC, who have not responded to at 
least one systemic therapy, or who have progressed following resection. The patient must be a candidate 
for treatment at the time of the testing. 
3. Previously diagnosed patients with advanced (stage IIIB or IV) NSCLC, who have been resistant to at 
least one targeted therapy, are able to undergo tumor tissue biopsy for testing, and who are suitable 
candidates for additional treatment at the time of testing.  
Metastatic Colorectal Cancer (mCRC) 
Indications and Limitations of Coverage 
Genomic Sequential Analysis Panel will be considered reasonable and necessary when the test is performed in 
a CLIA-certified laboratory qualified to perform high complexity testing, ordered by a treating physician, and 
the patient has:  
1. metastatic CRC; and 
2. is a candidate for intensive chemotherapy with an anti-EGFR biologic agent; and 
3. has not had prior RAS/BRAF testing (except after initiation of anti-EGFR therapy with evidence of 
acquired resistance). 
Next-Generation Sequence (NGS) Comprehensive Genomic Profile (CGP) Testing 
Indications and Limitations of Coverage This policy section describes coverage of NGS CGP diagnostic testing for patients with advanced cancer as 
allowable by a Medicare Administrative Contractor (MAC) under the National Coverage Determination (NCD) 
90.2 (1). The policy scope is specific to solid tumors and exclusive of hematologic malignancies (the subject of 
separate LCD L37606), circulating tumor DNA testing (ctDNA), and other cancer-related uses of NGS, such as 
germline testing. 
CGP is a NGS approach that uses a single assay to assess hundreds of genes including relevant cancer 
biomarkers, with solid evidentiary support for clinical utility in guidelines and clinical trials. CGP assays 
include not only individual genetic variants (single nucleotide variants (SNVs), insertions/deletions (INDELs), 
copy number alterations (CNAs), structural variants (SVs), and splice-site variants), but also patterns of 
mutations such as DNA mismatch repair deficiency (dMMR), microsatellite instability (MSI), and total 
mutational burden (TMB). CGP testing may also include RNA sequencing to detect structural rearrangements, 
such as fusions/translocations and functional splicing mutations. 
CGP NGS testing for patients with advanced cancer is reasonable and necessary only when performed in a 
CLIA-certified laboratory, when ordered by a treating physician, and when the patient has: 
1. either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and 
2. not been previously tested with a CGP for the same cancer genetic content; and 
3. decided to seek further cancer treatment (e.g., therapeutic chemotherapy) 
Additionally, the test performed must be able to detect at least the minimum genes and genomic positions 
required for the identification of clinically supported, FDA-approved therapies. The genes and genomic 
positions required are listed in Category 1 or 2A of the most current version of the National Comprehensive 
Cancer Network (NCCN) Biomarkers Compendium (2). Testing assays must be FDA approved/cleared, or if a 
laboratory developed test (LDT), have a published, peer-reviewed study supporting analytic validity, or 
certification by a third-party consistent with the New York State Department of Healths Clinical Laboratory 
Evaluation Program (CLEP) review standards. 
You can find these rules in the Local Coverage Determination (LCD) for Genomic Sequence Analysis Panels 
in the Treatment of Solid Organ Neoplasms, L37810. 
 
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.