Article - Billing and Coding: MolDX: Minimal Residual Disease Testing for Solid Tumor Cancers (A58456)

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.CMS Internet-Only Manuals, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.1.2 A/B MAC (B) Contacts With Independent Clinical LaboratoriesArticle 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 L38816.A Minimal Residual Disease (MRD) test, as defined in the related LCD this policy, is aservicethat 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 UseTestPATIENTS WITH CANCER-Initial Testwhere tumor profiling is utilized - from a prior analysisSignatera Bespoke Assay Design (by comprehensive genomic profile (CGP)) + Plasma SeriesBundlefor Molecular Residual Disease (Natera, Inc)where tumor profiling is utilizedSignatera Whole Exome + Plasma SeriesBundlefor Molecular Residual Disease (Natera, Inc)tumor nave testingGuardant Reveal MRDBundle(Guardant, Inc)Guardant360 ResponseSubsequent TestMay only be performed if there is clinical evidence of apriorichange in genetic contentSignateraRecurrence MonitoringPlasma TestBundle(Natera, Inc)PATIENTS WITHOUT CANCER (as defined in the policy)Initial Testwhere tumor profiling is utilized - from a prior analysisSignateraRecurrence MonitoringBespoke Assay Design (CGP) + single Plasma Test (Natera, Inc)where tumor profiling is utilizedSignateraRecurrence MonitoringWhole Exome Design + single Plasma Test (Natera, Inc)RaDaRRecurrence MonitoringWhole Exome Design + single Plasma Test (NeoGenomics Laboratories, Inc)Subsequent TestSignateraRecurrence Monitoringsingle Plasma Test (Natera, Inc)RaDaRRecurrence Monitoringsingle Plasma Test (NeoGenomics Laboratories, Inc)Tumor Nave TestoWhere baseline tumor profiling is not utilizedNavDX (Naveris, Inc) single Plasma TestAdditional Test-specific Indications, Limitations and InstructionsIntended 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:MolDXmay make available specific forms to assist with test Technical Assessments (TAs). Please follow the instructions on the MolDXwebsite 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 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.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 CPTcode 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 DEXDiagnostic 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 5010A1 837PItem 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.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.