Article - Billing and Coding: MolDX: Molecular Testing for Solid Organ Allograft Rejection (A58019)

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 Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.1.2 - A/B MAC (B) Contacts With Independent Clinical LaboratoriesCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, 50.5 Jurisdiction of Laboratory Claims, 60.1.1 Independent Laboratory Specimen Drawing, 60.2. Travel AllowanceCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, 10 Reporting ICD Diagnosis and Procedure CodesArticle TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Molecular Testing for Solid Organ Allograft Rejection L38568.Billing information-Different Z-Code identifiers must be used for protocol vs for-cause testing. This will allow this contractor to better understand the intended use of the test.To report a service, please submit the following claim information:Select CPTcodeEnter 1 unit of service (UOS)Enter the appropriate DEX Z-Code identifier 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 837PBox 19 for paper claimEnter the appropriate DEX Z-Code identifier 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 codeWhile all covered services can be identified on the DEX registry (dexzcodes.com), below is a list of tests covered under this policy.Solid Organ Allograft Rejection Tests that meet coverage criteria of policy L38568The tests below have completed a MolDx technical assessment and are deemed compliant with policy.However, the tests must be billed in accordance with the specific required indications/coverage criteria outlined in the policy.Test(Manufacturer)MethodologySpecimen SourceAnalyte(s) andPrinciple of TestTransplant Type(s)Allomap(CareDX)GEP(qRT-PCR)BloodGEP is used to calculate a score associated with the level of immune quiescence and probability of ARHeartAllosure(CareDX)NGS(targeting 266 SNPs)Blood% dd-cfDNA is measured to identify graft injury and ARKidneyHeartLungHeartCare(CareDX)AlloSure Heart + AlloMap Heart performed on the same patient sampleBloodSee AlloSure Heart and AlloMap HeartHeartProspera(Natera)mmPCR-NGS(targeting 13,926 SNPs)Blood% dd-cfDNA is measured to identify graft injury and ARKidneyHeartLungQSant(NephroSant)Multianalyte assay with algorithmic analysisUrineThe concentrations of 6 urinary biomarkers (cell- free DNA (cfDNA), methylated cfDNA (m-cfDNA), CXCL10, clusterin, total protein and creatinine) are incorporated into an algorithm to calculate a composite score (Q-score), to demonstrate the probability of rejection risk.KidneyTruGraf(Transplant Genomics)GEP(RT-PCR)BloodGEP signatures identify patients that are adequately immunosuppressedKidneyViracor TRAC (Transplant Rejection Allograft Check) (Eurofins)Low-coverage whole genome sequencing (WGS) querying >100,000 SNPsBlood% dd-cfDNA is measured to identify ARKidneyVitaGraft/Allaro Kidney (Oncocyte)droplet digital PCR (ddPCR)Blood% dd-cfDNA is measured to identify graft injury and ARKidneyAR: acute rejection; dd-cfDNA: donor-derived cell-free DNA; GEP: gene expression profile; NGS: next generation sequencing; PCR: polymerase chain reaction; WGS: whole genome sequencing