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 L38816.

A Minimal Residual Disease (MRD) test, as defined in the related LCD this
policy, 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)

RaDaR _Recurrence Monitoring_ Whole Exome Design + single Plasma Test
(NeoGenomics Laboratories, Inc)  
  
  * **_Subsequent Test_**

|

Signatera _Recurrence Monitoring_ single Plasma Test (Natera, Inc)

RaDaR _Recurrence Monitoring_ single Plasma Test (NeoGenomics Laboratories,
Inc)  
  
  * **Tumor Na ive Test**

****

o Where baseline tumor profiling is not utilized

|

NavDX (Naveris, Inc) single Plasma Test  
  
**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 (Natera and Guardant), bladder and breast cancers (Natera)
(2) the diagnosis of disease recurrence or relapse for advanced breast (RaDaR)
and HPV-driven oropharyngeal cancer (Naveris) (3) the monitoring of response
to immune-checkpoint inhibitor therapy for colorectal cancer (Guardant) or any
solid tumor (Natera). 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 DEX Z-Code.

**Billing instructions:**

Billing requires a Z-Code to be submitted with the claim. All tests must be
registered with the DEX 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-Code 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
    * Item 19 for paper claim
  * Enter the appropriate DEX Z-Code 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

**NOTE:** When entering the DEX Z-Code on the SV101-7 documentation field for
Part B claims please do not add additional characters and/or information on
the line.

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.