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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 all of the following must be present for coverage eligibility of lab-developed tests (LDTs): 
 
1. The patient must have: 
 
a. any cancer diagnosis 
b. AND a clinical indication for germline (inherited) testing for hereditary cancer 
c. AND a risk factor for germline (inherited) cancer 
d. AND has not been previously tested for the same germline genetic content 
 
2. The test has satisfactorily completed a Technical Assessment (TA) by Molecular Diagnostic Services 
Program (MolDX) for the stated indications of the test. 
3. 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. 
 
a. 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. 
b. 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. 
 
4. 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. 
5. If the test is an Next Generation Sequencing test, it must abide by all conditions listed in the NCD 90.2. 
 
You can find this rule in the Local Coverage Determination (LCD) - Lab-Developed Tests for Inherited Cancer 
Syndromes in Patients with Cancer (L38966) - Effective July 3, 2022. 
 
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). 
 
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. 
 
You can find this rule in the National Coverage Determination (NCD)  Next Generation Sequencing (NGS) 
(90.2)  Effective January 27, 2020. 
 
The rules say that 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 National Coverage Determination (NCD)  Next Generation Sequencing (NGS) 
(90.2)  Effective January 27, 2020. 
 
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.