Article - Billing and Coding: MolDX: Minimal Residual Disease Testing for Hematologic Cancers (A59004)

CMS National Coverage PolicyTitle XVIII of the Social Security Act 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Article TextThe 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 policyManufacturerTestIndicated Uses and LimitationsAdaptive BiotechnologiesClonoSeqNote: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 CLONOSEQfor 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. Theservicemay be performed once per patient per cancer diagnosis, unless there is clinical evidence ofa priorichange in genetic content.For patients without cancer (as defined in the policy), a second kind of test may exist wherein asingle timepointmay 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 CPT81479 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 DEX Diagnostic Exchange application.To report an episode of testing, please submit the following claim information:Select the appropriate CPTcode. 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-Codeidentifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A 837PBox 19 for paper claimEnter the appropriate DEX Z-Codeidentifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formSelect the appropriate ICD-10-CM codeNOTE:When entering the DEX Z-Codeon the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line.