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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 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 This Contractor provides limited coverage for MRD testing in cancer when ALL of the 
following are true: 
1. If Next-Generation Sequencing (NGS) methodology is used in testing, the conditions set by NCD 90.2 
are fulfilled (summarized: the patient has advanced cancer; plans on being treated for said cancer and 
has not been previously tested with the same test for the same genetic content) or are not applicable (the 
patient does not have cancer as defined below). 
2. The patient has a personal history of cancer, the type and staging of which is within the intended use of 
the MRD test. 
3. The identification of recurrence or progression of disease within the intended use population of the test 
is identified in the National Comprehensive Cancer Network (NCCN) or other established guidelines as 
a condition that requires a definitive change in patient management. 
4. The test is demonstrated to identify molecular recurrence or progression before there is clinical, 
biological or radiographical evidence of recurrence or progression AND demonstrates sensitivity and 
specificity of subsequent recurrence or progression comparable with or superior to radiographical or 
other evidence (as per the standard-of-care for monitoring a given cancer type) of recurrence or 
progression. 
5. To be reasonable and necessary, it must also be medically acceptable that the test being utilized 
precludes other surveillance or monitoring tests intended to provide the same or similar information, 
unless they either (a) are required to follow-up or confirm the findings of this test or (b) are medically 
required for further assessment and management of the patient. 6. If the test is to be used for monitoring a specific therapeutic response, it must demonstrate the clinical 
validity of its results in published literature for the explicit management or therapy indication (allowing 
for the use of different drugs within the same therapeutic class, so long as they are considered 
'equivalent and interchangeable' for the purpose of MRD testing, as determined by national or society 
guidelines). 
7. Clinical validity (CV) of any analytes (or expression profiles) measured must be established through a 
study published in the peer-reviewed literature for the intended use of the test in the intended 
population. 
8. The test is being used (a) in a patient who is part of the population in which the test was analytically 
validated and (b) according to the intended use of the test. 
9. The MRD test [unless it is a Food and Drug Administration (FDA) approved and established standard-
of-care single-gene polymerase chain reaction (PCR)] satisfactorily completes a technical assessment 
(TA) that will evaluate and confirm that the analytical validity, clinical validity, and clinical utility 
criteria set in this policy are met to establish the test as Reasonable and Necessary. 

You can find this rule in Local Coverage Determination (LCD) MolDX: Minimal Residual Disease Testing for 
Cancer L38835. 
 
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.