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 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 RNA sequencing and protein analysis. 
Indications and Limitations of Coverage 
 
B.    Nationally Covered Indications 
 
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 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. 
 
C.    Nationally Non-Covered Indications 
 
1. Somatic (Acquired) Cancer 
 
Effective for services performed on or after March 16, 2018, NGS as a diagnostic laboratory test for patients 
with acquired (somatic) cancer are non-covered if the cancer patient does not meet the criteria noted in section 
B.1., above. 
 
D.    Other 
 
1.    Somatic (Acquired) Cancer 
 
Effective for services performed on or after March 16, 2018, Medicare Administrative Contractors (MACs) 
may determine coverage of NGS as a diagnostic laboratory test for patients with advanced cancer only when 
the test is performed in a CLIA-certified laboratory, when ordered by a treating physician, and when the patient 
has: 
 
    either recurrent, relapsed, refractory, metastatic, or advanced stages 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). 
 
2.    Germline (Inherited) Cancer 
 
Effective for services performed on or after January 27, 2020, MACs may determine coverage of NGS as a 
diagnostic laboratory test for patients with germline (inherited) cancer only when the test is performed in a 
CLIA-certified laboratory, when ordered by a treating physician, when results are provided to the treating 
physician for management of the patient and when the patient has: 
     any cancer diagnosis; and, 
    a clinical indication for germline (inherited) testing of hereditary cancers; and, 
    a risk factor for germline (inherited) cancer; and, 
    not been previously tested with the same germline test using NGS for the same germline genetic content. 
 
You can find these rules in the National Coverage Determination (NCD) Next Generation Sequencing (NGS) 
90.2. 
 
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.