Billing and Coding: MolDX: Molecular Testing for Solid Organ Allograft
Rejection

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Molecular
Testing for Solid Organ Allograft Rejection DL38582.

**INTERPRETATIVE AND EDUCATIONAL INFORMATION**

The below section provides additional interpretative and educational content
to help providers and other stakeholders better understand the intent of the
existing coverage criteria language of the policy. Reasonable and necessary
thresholds for coverage are defined in the policy Coverage Criteria section
and are not altered by the article language.

**Intended use requirements**

Tests within scope of the policy must comply with the stated requirements of
the coverage criteria of the policy. The policy lists intended uses, that when
met, can allow for coverage of services within scope of the policy, provided
all other listed requirements are also met. Of note, the analysis of the
evidence in the policy reflects the underlying value proposition of the test
as one that can preclude an unnecessary tissue biopsy. This is therefore
reflected in the intended use section of the coverage criteria.

The four intended uses that are established in the policy all require that the
physician is concerned about at least one of the following: rejection (and
would otherwise obtain a biopsy to evaluate the allograft), the adequacy of
immunosuppression (and would otherwise obtain a biopsy to evaluate the
allograft or is considering doing so), the probability of rejection with
concerning clinical information (clinical pre-tests/information that inform
whether a subsequent biopsy would likely be avoided), and/or the results of an
inconclusive biopsy (wherein the test may subsequently preclude another
biopsy).

In all scenarios presented the patients must be in consideration for a tissue
biopsy or additional biopsy (such that the test prevents this when the biopsy
won't likely be of benefit) OR require allograft evaluation because of _a
priori_ concern for rejection or rejection risk due to clinical or biological
factors (pre-test). No other intended uses are allowed by the policy.

This leads to the following conclusions:

-If a biopsy is performed, the test and the biopsy cannot be performed simultaneously or within a short window of time such that the test cannot reasonably inform medical management regarding the biopsy. Performance of the test simultaneously with biopsy or within a very narrow window of time from biopsy such that the results would not be available prior to the biopsy being performed would infer that the biopsy is performed regardless of test result and therefore the test has no impact on patient management. This is not consistent with the policy language.

-Per policy, one of the intended uses of the molecular test is "For further evaluation of allograft status for the probability of allograft rejection after a physician-assessed pretest."  
A pre-test is defined here as "other physiologic/laboratory/clinical evidence
consistent with rejection or risk of rejection" wherein additional evaluation
is subsequently warranted. Therefore, the information that leads to the use of
the test must pre-exist the performance of the test. The results of the pre-
test must be available to the treating clinician to inform the need for a
molecular test or biopsy. Performing the test before such conditions exist, or
to establish such a condition cannot be interpreted to be in compliance with
the policy.

-Although most coverage criteria are relevant to _for cause_ tests, if a patient population exists such that they are at particularly high risk for rejection, and the pre-test clinical information would otherwise indicate a biopsy to evaluate the allograft health based on the risk of that population, the use of these services may fit within the intent of the policy coverage criteria language and analysis rationale.

An example of this may be in heart allografts within the first year of
transplant that would otherwise get a tissue biopsy due to evaluated pre-test
risk. As such, the use of a molecular test for surveillance (protocol) testing
can only be reasonably seen as compliant with the policy if the patient would
otherwise receive a surveillance (protocol) biopsy. Providers must demonstrate
that such a practice (for protocol biopsies) would otherwise be performed to
meet policy requirements. Other uses of surveillance testing are not compliant
with the policy language and would require policy reconsideration for
inclusion.

**Additional billing information**

-For a given patient encounter, only one molecular test for assessing allograft rejection status (within scope of this policy) may be billed. Any additional molecular tests billed after the first will be denied. Of note, services that include multiple components are considered a single service by MolDX and should be registered as such, in alignment with established MolDX practice.

-Different Z-Code identifiers must be used for protocol vs for-cause testing. This will allow this contractor to better understand the intended use of the test.

To report a service, please submit the following claim information:

  * Select CPT code
  * Enter 1 unit of service (UOS)
  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:  

    * Loop 2400 or SV101-7 for the 5010A1 837P
    * Box 19 for paper claim
  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types: 
    * Line SV202-7 for 837I electronic claim
    * Block 80 for the UB04 claim form
  * Select the appropriate ICD-10-CM code

Covered services can be identified on the DEX registry
([dexzcodes.com](https://www.dexzcodes.com/)).