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 state 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: 
 
    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 patient?s cancer; and, 
    results provided to the treating physician for management of the patient using a report template to specify 
treatment options. 
 
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. 
 
You can find these rules in National Coverage Determination (NCD) for Next Generation Sequencing (NGS) 
(90.2). 
 
The rules also say MolDX will review all new test/assay clinical information to determine if a test meets 
Medicare?s reasonable and necessary requirement. Labs must submit a comprehensive dossier on each new 
test/assay prior to claim submission. MolDX will only cover and reimburse tests that demonstrate analytical 
and clinical validity, and clinical utility at a level that meets the Medicare reasonable and necessary 
requirement. 
 
MolDX will reimburse: 
 
    approved tests covered for dates of service consistent with the effective date of the coverage determination. 
 
You can find these rules in Local Coverage Determination (LCD): MolDX: Molecular Diagnostic Tests (MDT) 
(L36021). 
 
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.