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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 medically necessary services are those that are reasonable and necessary for the diagnosis or 
treatment of an illness or injury. Medically necessary services include services to improve the functioning of a 
malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). 
 
The rules say that services that are not medically necessary are not covered. The rules also say that 
experimental and investigational devices are not covered. You can find this rule at 42 CFR Sections 411.15 and 
411.15(o). 
 
The rules say 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. 
A.    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: 
i. either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and 
ii. not been previously tested with the same test using NGS for the same cancer genetic content, and 
iii. decided to seek further cancer treatment (e.g., therapeutic chemotherapy). 
   b. The diagnostic laboratory test using NGS must have:  i. Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic; 
and, 
ii. an FDA-approved or -cleared indication for use in that patients cancer; and, 
iii. 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: 
i. ovarian or breast cancer; and, 
ii. a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer; and, 
iii. a risk factor for germline (inherited) breast or ovarian cancer; and 
iv. 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: 
i. FDA-approval or clearance; and, 
ii. results provided to the treating physician for management of the patient using a report template to 
specify treatment options. 
You can find this rule in the Centers for Medicare and Medicaid Services, Internet Only Manual, Publication 
100-03, Medicare National Coverage Determinations Manual, Section 90.2. 
The rules say that all the following must be present for coverage eligibility for lab-developed tests for inherited 
cancer syndromes in patients with cancer: 
 The patient must have:  
o Any cancer diagnosis 
o AND a clinical indication for germline (inherited) testing for hereditary cancer 
o AND a risk factor for germline (inherited) cancer  
o AND has not been previously tested for the same germline genetic content. 
 The test has satisfactorily completed a Technical Assessment (TA) by Molecular Diagnostic Services 
Program (MolDX

) for the stated indications of the test. 
 The test performed includes at least the minimum genetic content (genes or genetic variants) with 
definitive or well-established guidelines-based evidence required for clinical decision making for its 
intended use that can be reasonably detected by the test.  
o 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.  
o A single gene or variant may be tested if it is the only gene or variant considered to be 
reasonable and necessary for a cancer type.   If a previous test was performed with a similar/duplicative intended use, a subsequent test is only 
reasonable and necessary if the non-duplicative genetic content of the second test is reasonable and 
necessary. 
 If the test is an NGS test, it must abide by all conditions listed in the NCD 90.2. 
You can find this rule in the Local Coverage Determination (LCD): MolDX: Lab-Developed Tests for 
Inherited Cancer syndromes in Patients with Cancer (L38966). 
 
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.