Billing and Coding: MolDX: Minimal Residual Disease Testing for Hematologic
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 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 policy. The medical record must contain clear documentation of
the medical necessity of this test, as per the conditions outlined in the
policy.  
  
The following tests have met the criteria for coverage under the policy

**Manufacturer** | **Test** | **Indicated Uses and Limitations**  
---|---|---  
Adaptive Biotechnologies |

ClonoSeq

**Note:** An episode of testing typically requires a baseline assay and
multiple follow-up assays.

| Acute lymphoblastic leukemia (ALL), Multiple myeloma (MM), and Chronic
lymphocytic leukemia (CLL) and Diffuse Large B-Cell Lymphoma (DLBCL). Refer to
CPT/HCPCS Group 2 for additional instructions and select the appropriate
ICD-10 code listed under ICD-10 Codes that Support Medical Necessity Group 2
Codes.  
  
This Table will be updated to reflect revisions and additions of newly covered
tests.

Coverage of CLONOSEQ 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.

**Single-gene PCR tests:**  
For patients with or without cancer (as defined in the policy), established
standard-of-care MRD tests using single-gene PCR (i.e., BCR-ABL1) may be
billed on an individual basis according to testing schedules outlined in
national (i.e., NCCN) or society guidelines, with 1 UOS for each date of
service. Refer to CPT/HCPCS Group 3 for additional instructions and select the
appropriate ICD-10 code listed under ICD-10 Codes that Support Medical
Necessity Group 3 Codes.

  * Regarding single-gene and panel testing of genes - Refer to definitions and instructions in Billing and Coding: MolDX: Testing of Multiple Genes A57880 and Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) A57772.

**Other tests (i.e., ClonoSeq ):**

For patients with cancer, the unit of service 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., ClonoSeq) 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.

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 81479 and one (1) UOS with the assigned DEX 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 5010A 837P
    * Box 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