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 plans may choose the networks of providers available to enrollees and may require enrollees 
to obtain authorization before receiving services. You can find this rule at 42 CFR Section 422.112(a) and in 
the Centers for Medicare and Medicaid Services, Internet Only Manual, Publication 100-16, Medicare 
Managed Care Manual, Chapter 1, Section 20.2. 
 
The rules say that all the following must be present for coverage eligibility: 
 As per National Coverage Determination (NCD) 90.2, this test is reasonable and necessary when: 
o the patient has either: 
 Recurrent cancer 
 Relapsed cancer 
 Refractory cancer 
 Metastatic cancer 
 Advanced cancer (stages III or IV) 
o AND has not been previously tested by the same test for the same genetic content 
o AND is seeking further treatment 
 The test has satisfactorily completed a TA by MolDX for the stated indications of the test 
 The assay performed includes at least the minimum genes and genomic positions required for the 
identification of clinically relevant FDA-approved therapies with a companion diagnostic biomarker as 
well as other biomarkers known to be necessary for clinical decision making for its intended use that 
can be reasonably detected by the test. 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. 
 
The test in question will be non-covered if it does not fulfill all the criteria set forth in the NCD 90.2. You can 
find this rule in the Local Coverage Determination (LCD) for molecular diagnostics (MolDX): Next-
Generation Sequencing for Solid Tumors, L38119. 
 
 
 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. The diagnostic laboratory test using next generation sequencing must have Food and Drug Administration 
(FDA) approval or clearance as a companion in vitro diagnostic. You can find this rule in the Centers for 
Medicare and Medicaid Services, Internet Only Manual, Publication 100-03, Medicare National Coverage 
Determination for Next Generation Sequencing, 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. The Plan 
contract says that, with limited exceptions, members of the Plan must use network providers to get medical care 
and services. The only exceptions are emergencies, urgently needed care when the network is not available 
(generally, when the enrollee is out of the area), out-of-area dialysis services, and cases in which the Plan 
authorizes the use of out-of-network providers. You can find this information on page 43 of the Plan's 2021 
Evidence of Coverage.