Article - Billing and Coding: MolDX: Abbott RealTime IDH1 and IDH2 testing for Acute Myeloid Leukemia (AML) (A55716)

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 TextTheAbbott RealTime IDH1by Abbott Molecular is the only test that has received FDA approval to be usedas an aid in identifying acute myeloid leukemia (AML) patients with an isocitrate dehydrogenase-1(IDH1) mutation for treatment with TIBSOVO(ivosidenib).TIBSOVO(ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.Abbott RealTime IDH1byAbbott Molecular meets the reasonable and necessary criteria for Medicare reimbursement, effective 7/20/2018.The Abbott RealTime IDH2by Abbott Molecular is the only test that has received FDA approval to be usedas an aid in identifying acute myeloid leukemia (AML) patients with an isocitrate dehydrogenase-2 mutation for treatment with enasidenib (IDHIFA).IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.Abbott RealTime IDH2by Abbott Molecular meets the reasonable and necessary criteria for Medicare reimbursement, effective 8/1/2017.To report anAbbott RealTime IDH1service, please submit the following claim information:Select the CPT 81120 for claims on or after 7/20/2018.To report anAbbott RealTime IDH2service, please submit the following claim information:Select the CPT code 81121 for claims on or after 01/01/2018Enter 1 unit of service (UOS)Enter the appropriate DEX Z-Codeidentifier 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 837PBox 19 for paper claimEnter the appropriate DEX Z-Codeidentifier adjacent to the CPT code 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:This MolDX coverage determination and coding guideline ONLY applies to the UNMODIFIED, IDH2 test kit by Abbott Molecular for patients with acute myeloid leukemia. If a lab modifies these tests, a MolDX Technical Assessment, outlined in the MolDx section onwww.PalmettoGBA.com/medicare, must be submitted and a determination assessed prior to claims submission.This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.