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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. 
 
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. You can find these rules in the National Coverage Determination (NCD) Next Generation 
Sequencing (NGS) 90.2. 
 
The rules say that NGS is not a specific test, but a sequencing methodology utilized to capture genomic 
information. Unlike Sanger sequencing (the prior standard technology) that typically provides sequence 
information for a single deoxyribonucleic acid (DNA) strand/molecule, NGS allows for massively parallel 
sequencing of millions of DNA molecules concurrently.21,22 This allows for capturing many relevant genomic 
targets simultaneously, usually by utilizing capture technologies such as polymerase chain reaction (PCR) amplification or hybrid capture. As such, NGS tests for use in cancer are often comprised of gene panels whose 
content is either relevant to a specific tumor type or condition, or a larger panel of genes that can be used for 
multiple tumor types. 
 
Because of the number of variables described above, additional work must be performed to assess if any given 
test is both reasonable and necessary for Medicare beneficiaries and to ensure that Medicare claims are 
properly understood and executed. Molecular Diagnostic Services Program (MolDX) has instituted a process 
for completing a Technical Assessment (TA) that ensures that tests are appropriate for their indications and are 
properly validated according to published guidelines described above (when applicable). Specifically, in order 
to understand if a test is both reasonable and necessary, it must be delineated if a test has the properly validated 
technology, variant types, gene and variant coverage, and bioinformatics capability to deliver a clinically useful 
result for the Medicare beneficiary, given their diagnosis. 
 
Labs seeking coverage for LDTs, FDA-cleared, or FDA-approved tests that are not nationally covered utilizing 
NGS in cancer must submit documentation to allow MolDX to complete a TA. Forms to complete the 
process are available on the MolDX website. Tests that are currently covered by Palmetto GBA are not 
exempt from this process. Tests that are currently covered and have not undergone a TA by MolDX will be 
non-covered unless complete documents to perform a TA are submitted in a timely manner described below. 
 
Criteria for Coverage 
All the following must be present for coverage eligibility: 
As per NCD 90.2, this test is reasonable and necessary when: 
the patient has either: 
Recurrent cancer 
Relapsed cancer 
Refractory cancer 
Metastatic cancer 
Advanced cancer (stages III or IV) 
AND has not been previously tested by the same test for the same genetic content 
AND is seeking further treatment 
The test has satisfactorily completed a TA by MolDX for the stated indications of the test 
The assay performed includes at least the minimum genes and genomic positions required for the identification 
of clinically relevant FDA-approved therapies with a companion diagnostic biomarker as well as other 
biomarkers known to be necessary for clinical decision making for its intended use that can be reasonably 
detected by the test. Because these genes and variants will change as the literature and drug indications evolve, 
they are listed separately in associated documents such as the MolDX TA forms. 
Situations in which Test should not be used or coverage is denied: 
 
The test in question will be non-covered if: 
 
It does not fulfill all the criteria set forth in the NCD 90.2 as stated above 
Another CGP test was performed on the same tumor specimen (specimen obtained on the same date of service) 
A TA is not completed satisfactorily by MolDX for new tests 
For tests that are currently covered but a TA submission has not been made, providers must submit completed 
TA materials by February 10th, 2020, or coverage will be denied. You can find these rules in the Local 
Coverage Determination (LCD) MolDX: Next-Generation Sequencing for Solid Tumors L38121. 
 
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.