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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 that 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). 
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. 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: 
a. either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and, 
b. not been previously tested with the same test using NGS for the same cancer genetic content, and 
c. decided to seek further cancer treatment (e.g., therapeutic chemotherapy). 
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: 
a. any cancer diagnosis; and, 
b. a clinical indication for germline (inherited) testing of hereditary cancers; and, 
c. a risk factor for germline (inherited) cancer; and, 
d. not been previously tested with the same germline test using NGS for the same germline genetic 
content. 
You can find this information 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.