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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 molecular diagnostic tests that assess a transplanted allograft for rejection status are covered 
when ALL of the following criteria are met: 
1. The test must provide information about at least one of the two following clinical status determinations: 
a. AR status 
b. Cellular or Antibody-mediated rejection (ACR or AMR) status 
2. The intended use of the test must be: 
a. To assist in the evaluation of adequacy of immunosuppression, wherein a non-invasive or 
minimally invasive test can be used in lieu of a tissue biopsy in a patient for whom information 
from a tissue biopsy would be used to make a management decision regarding 
immunosuppression, OR 
b. As a rule-out test for AR in validated populations of patients with clinical suspicion of rejection 
with a non-invasive or minimally invasive test to make a clinical decision regarding obtaining a 
biopsy, OR 
c. For further evaluation of allograft status for the probability of allograft rejection after a 
physician-assessed pretest, OR 
d. To assess rejection status in patients that have received a biopsy, but the biopsy results are 
inconclusive or limited by insufficient material. 
3. The test demonstrates analytical validity (AV), including an analytical and clinical validation for any 
given measured analytes, and has demonstrated equivalence or superiority for sensitivity or specificity 
(depending on intended use) of detecting allograft rejection to other already-accepted tests for the same 
intended use measuring the same or directly comparable analytes. 
4. 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. The degree of validity must be similar or superior to established and covered tests (see 
associated coverage Articles). If conducted with concordance to tissue histologic evaluation the Banff 
Classification for renal allografts or other accepted criteria (if existing) for other organs must be used. 
5. The test is being used in a patient who is part of the population in which the test was analytically 
validated and has demonstrated CV. 
6. For a given patient encounter, only one molecular test for assessing allograft status may be performed 
UNLESS a second test, meeting all the criteria established herein, is reasonable and necessary as an 
adjunct to the first test. 
7. For minimally or non-invasive tests, the benefit to risk profile of the molecular test is considered by the 
ordering clinician to be more favorable than the benefit to risk profile of a tissue biopsy, or a tissue 
biopsy cannot be obtained. For example, this may be the case if a biopsy is considered medically 
contraindicated in a patient. 
8. The test successfully completes a Technical Assessment that will ensure that AV, CV, and clinical 
utility criteria set in this policy are met to establish the test as Reasonable and Necessary. 
Covered tests with AV that is significantly below similar services may have coverage rescinded. You can find 
this rule in Local Coverage Determination (LCD) MolDX: Molecular Testing for Solid Organ Allograft 
Rejection L38629. 
  
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.