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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 this Medicare contractor will provide limited coverage for tests performed using the AlloSure 
donor-derived cell-free DNA assay (CareDx

Inc., Brisbane, CA) for the following indications: 
1. AlloSure Kidney is covered to assess the probability of allograft rejection in kidney transplant 
recipients with clinical suspicion of rejection and to inform clinical decision-making about the necessity 
of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical 
assessment. 
2. AlloSure Heart is covered when used in conjunction with AlloMap to assess the probability of    
allograft rejection in heart transplant recipients with clinical suspicion of rejection and to inform clinical 
decision-making about the necessity of a heart biopsy in such patients at least 55 days post-transplant in 
conjunction with standard clinical assessment. 
Other tests that demonstrate similar indicated uses and similar performance to AlloSure

, as demonstrated in a 
technical assessment, may similarly be covered under this policy. 
 
You can find this rule in the Local Coverage Determination (LCD): AlloSure or Equivalent Cell-Free DNA 
Testing for Kidney and Heart Allografts (L38355). 
The rules say this Medicare contractor will provide limited coverage for molecular diagnostic tests used in the 
evaluation and management of patients who have undergone solid organ transplantation. These tests can inform 
decision making along with standard clinical assessments in their evaluation of organ injury for active rejection 
(AR). 
 These tests may be ordered by qualified physicians considering the diagnosis of AR affiliated with a transplant 
center, helping to rule in or out this condition when assessing the need for or results of a diagnostic biopsy. 
They should be considered along with other clinical evaluations and results and may be particularly useful in 
patients with significant contraindications to invasive procedures. 
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. 
You can find this rule in the Local Coverage Determination (LCD): 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.