Billing and Coding: MolDX: Minimal Residual Disease Testing for Solid Tumor
Cancers

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Minimal
Residual Disease Testing for Cancer L38835.

A Minimal Residual Disease (MRD) test, as defined in the related LCD, is a
_service_ that may include multiple components and/or multiple timepoints
(i.e., serial assays). **Testing schedules are set based on the validity
established for the individual test comprising the service.** Each component
and timepoint of the service must be reasonable and necessary and adhere to
the criteria set forth in the related LCD. The medical record must contain
clear documentation of the medical necessity of this test, as per the
conditions outlined in the LCD

**The following tests have met the criteria for coverage under the policy:**

**Indicated Use** | **Test**  
---|---  
  
**PATIENTS WITH CANCER-**

  * **Initial Test**

|  
  
  *     * where tumor profiling is utilized - from a prior analysis

| Signatera Bespoke Assay Design (by comprehensive genomic profile (CGP)) +
Plasma Series **Bundle** for Molecular Residual Disease (Natera, Inc)  
  
  *     * where tumor profiling is utilized

| Signatera Whole Exome + Plasma Series **Bundle** for Molecular Residual
Disease (Natera, Inc)  
  
  *     * tumor naive testing

|

Guardant Reveal MRD **Bundle** (Guardant, Inc)

Guardant360 Response  
  
  * **Subsequent Test**
    * May only be performed if there is clinical evidence of a _priori_ change in genetic content

| Signatera _Recurrence Monitoring_ Plasma Test Bundle (Natera, Inc)  
  
**PATIENTS WITHOUT CANCER (as defined in the policy) -**

  * **Initial Test**

|  
  
  *     * where tumor profiling is utilized - from a prior analysis

| Signatera _Recurrence Monitoring_ Bespoke Assay Design (CGP) + single Plasma
Test (Natera, Inc)  
  
  *     * where tumor profiling is utilized

| Signatera _Recurrence Monitoring_ Whole Exome Design + single Plasma Test
(Natera, Inc)  
  
  * **Subsequent test**

| Signatera _Recurrence Monitoring_ single Plasma Test (Natera, Inc)  
  
**Additional Test-specific Indications, Limitations and Instructions**

Intended uses that have met clinical validity (CV) criteria under the policy
include: (1) the diagnosis of disease progression, recurrence, or relapse for
advanced colorectal, bladder and breast cancers and (2) the monitoring of
response to immune-checkpoint inhibitor therapy for any solid tumor. However,
the tests listed in the table may have only been approved for one or more (but
not necessarily all) of these indications.  
  
**Note:** 'Bundle' refers to multiple plasma assays.  
  
These Tables will be updated to reflect revisions and additions of newly
covered tests.

Coverage of tests for other cancer indications and episodes of care, and
modifications to the definition of an episode of care will be evaluated as
needed.

**Additional process requirements for coverage and billing:**  
MolDX may make available specific forms to assist with test Technical
Assessments (TAs). Please follow the instructions on the MolDX website to
assist with this process. If such forms are available that pertain to the test
type in question, these forms are required for successful coverage
determinations.

For patients with cancer, the UOS for this type of test is 1. Billing should
occur at the start of the episode of testing. Regarding the use of NGS-based
MRD tests (i.e., Signatera) in patients with cancer- The service may be
performed once per patient per cancer diagnosis, unless there is clinical
evidence of _a priori_ change in genetic content.

For patients without cancer (as defined in the policy), a second kind of test
may exist wherein a single timepoint may constitute a single test (i.e., 1 UOS
for a given date of service). Testing in these patients will be accompanied by
the appropriate "Personal history of cancer" ICD-10 code. Testing may not be
performed more than once in a month; the testing schedule is set based on the
validity established of the individual test for the given indication.

NOTE: Prophylactic therapeutic interventions in patients with a history of
cancer are excluded from the definition of a patient "with cancer".

Refer to additional instructions outlined in the relevant Group sections
below.

**Regarding NGS panels:**  
To submit a claim for MRD analysis by NGS that measures multiple analytes, use
CPT code 81479 and 1 UOS with the assigned DEXTM Z-code.

**Billing instructions:**  
Billing requires a Z-identifier code to be submitted with the claim. All tests
must be registered with the DEXTM Diagnostic Exchange application.

**To report an episode of testing, please submit the following claim
information:**

  * Select the appropriate CPT code. If no specific CPT code exists for the test submitted, bill with the NOC code 81479.
  * 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

When submitting claims for the specific indicated use of monitoring response
to ICI therapy, the ICI drug name must be included on the claim in the
applicable detail line 2400 loop.