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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 clinical laboratory diagnostic tests can include tests that, for example, predict the risk 
associated with one or more genetic variations. In addition, in vitro companion diagnostic laboratory tests 
  
  provide a report of test results of genetic variations and are essential for the safe and effective use of a 
corresponding therapeutic product. Next Generation Sequencing (NGS) is one technique that can measure one 
or more genetic variations as a laboratory diagnostic test, such as when used as a companion in vitro diagnostic 
test. 
 
This National Coverage Determination (NCD) is only applicable to diagnostic lab tests using NGS for somatic 
(acquired) and germline (inherited) cancer. Medicare Administrative Contractors (MACs) may determine 
coverage of diagnostic lab tests using NGS for sequencing and protein analysis. 
 
1.    Somatic (Acquired) Cancer 
 
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: 
 
   a. Patient has: 
either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and 
not been previously tested with the same test using NGS for the same cancer genetic content, and 
decided to seek further cancer treatment (e.g., therapeutic chemotherapy). 
   b. 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 patients cancer; and, 
results provided to the treating physician for management of the patient using a report template to specify 
treatment options. 
2.    Germline (Inherited) Cancer 
 
Effective for services performed on or after January 27, 2020, CMS has determined that NGS as a diagnostic 
laboratory test is reasonable and necessary and covered nationally for patients with germline (inherited) cancer, 
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: 
 
   a. Patient has: 
ovarian or breast cancer; and, 
a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer; and, 
a risk factor for germline (inherited) breast or ovarian cancer; and 
not been previously tested with the same germline test using NGS for the same germline genetic content. 
   b. The diagnostic laboratory test using NGS must have all of the following: 
FDA-approval or clearance; 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 the National Coverage Determination (NCD) Next Generation 
Sequencing (NGS) 90.2. 
 
The rules say that this Medicare contractor will provide limited coverage for minimally invasive molecular 
deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) tests that detect minimal residual disease (MRD) in 
patients with a personal history of cancer. 
 
 This Contractor provides limited coverage for MRD testing in cancer when ALL of the following are true: 
 
If Next-Generation Sequencing (NGS) methodology is used in testing, the conditions set by NCD 90.2 are 
fulfilled (summarized: the patient has advanced cancer; plans on being treated for said cancer, and has not been previously tested with the same test for the same genetic content) or are not applicable (the patient does not 
have cancer as defined below); 
The patient has a personal history of cancer, the type and staging of which is within the intended use of the 
MRD test; 
The identification of recurrence or progression of disease within the intended use population of the test is 
identified in the National Comprehensive Cancer Network (NCCN) or other established guidelines as a 
condition that requires a definitive change in patient management; 
The test is demonstrated to identify molecular recurrence or progression before there is clinical, biological, or 
radiographical evidence of recurrence or progression AND demonstrates sensitivity and specificity of 
subsequent recurrence or progression comparable with or superior to radiographical or other evidence (as per 
the standard-of-care for monitoring a given cancer type) of recurrence or progression; 
To be reasonable and necessary, it must also be medically acceptable that the test being utilized precludes other 
surveillance or monitoring tests intended to provide the same or similar information, unless they either (a) are 
required to follow-up or confirm the findings of this test or (b) are medically required for further assessment 
and management of the patient; 
If the test is to be used for monitoring a specific therapeutic response, it must demonstrate the clinical validity 
of its results in published literature for the explicit management or therapy indication (allowing for the use of 
different drugs within the same therapeutic class, so long as they are considered equivalent and 
interchangeable for the purpose of MRD testing, as determined by national or society guidelines); 
Clinical validity (CV) of any analytes (or expression profiles) measured must be established through a study 
published in the peer-reviewed literature for the intended use of the test in the intended population; 
The test is being used (a) in a patient who is part of the population in which the test was analytically validated 
and (b) according to the intended use of the test; 
The MRD test [unless it is a Food and Drug Administration (FDA) approved and established standard-of-care 
single-gene polymerase chain reaction (PCR)] satisfactorily completes a technical assessment (TA) that will 
evaluate and confirm that the analytical validity, clinical validity, and clinical utility criteria set in this policy 
are met to establish the test as Reasonable and Necessary; 
Tests utilizing a similar methodology or evaluating a similar molecular analyte to a test for which there is a 
generally accepted testing standard or for which existing coverage exists must demonstrate equivalent or 
superior test performance (i.e., sensitivity and/or specificity) when used for the same indication in the same 
intended-use population. 
MRD testing often requires 2 types of assays to be performed as part of the service. First, a sample is taken 
from tumor diagnostic material to establish a baseline (solid and/or liquid) tumor signature as defined by the 
test methodology. This is followed by a series of assays run on a minimally invasive specimen (i.e., liquid 
biopsy or bone marrow aspirate) to detect the presence or recurrence of tumor, based on the measured 
biomarkers, expression, or other analytes over various timepoints. Other approaches are also acceptable, based 
on the validity established for the individual test comprising the service. This series of assays comprises a 
single test when the patient is known to have cancer. 
 
When the patient is NOT known to have cancer (specifically when there is no clinical, radiographical, or other 
biological evidence that tumor cells remain post treatment and subsequently the patient is no longer being 
subjected to therapeutic interventions for cancer), a second kind of test may exist wherein a single timepoint 
may constitute a single test. In such patients, the frequency of MRD testing is in accordance with national or 
society guidelines or recommendations. 
 
MRD testing in accordance with this policy can be performed using PCR and/or sequencing-based technologies 
and is not restricted to a single type of biological material or defined number of genes. You can find these rules 
in the Local Coverage Determination (LCD) MolDX: Minimal Residual Disease Testing for Cancer L38814. 
 
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.