Medicare Diagnostic Test Approval Disease Drug Company Therapeutic Role Payment Specified Type Type of Drug Category Margenza (margetuximab- Third-line for metastatic, HER2-neu receptor Macrogenics None Full Part B cmkb ) HER2+ disease antagonist Neoadjuvant for HER2+ early Phesgo (pertuzumab, HER2 protein BC, adjuvant for high risk trastuzumab, hyaluronidase- Genentech Conjugate overexpression or HER2 Full Part B HER2+ early BC, and first-line zzxf ) gene amplification for HER2+ metastatic BC. Breast Cancer (BC) Trop-2-directed Trodelvy® (sacituzumab antibody and Immunomedics Third-line for triple negative BC None Accelerated Part B govitecan-hziy) topoisomerase inhibitor conjugate Second-line for unresectable or Tukysa® (tucatinib ) Seattle Genetics Kinase inhibitor None Full Part D metastatic HER2+ BC Second-line for unresectable/metastatic Presence of an FGFR2 Cholangiosarcoma Pemazyre® (pemigatinib ) Incyte Kinase inhibitor Accelerated Part D disease with a FGFR2 fusion or fusion or rearrangement rearrangement Diffuse Large B-Cell Relapsed/refractory patients Monjuvi®(tafasitamab-cxix) MorphoSys/Incyte CD19-directed None Accelerated Part B Lymphoma who are not eligible for ASCT cytolytic antibody Patients with metastatic/locally advanced Epitheliod sarcoma None Accelerated disease ineligible for complete resection Methyltransferase Tazverik® (tazemetostat ) Epizyme, Inc. Third-line for Part D inhibitor relapsed/refractory EZH2+ Tumors are positive for Follicular Lymphoma (FL) positive disease and for FL Accelerated an EZH2 mutation patients w/o satisfactory treatment options. First-line for Positive for PDGFRA exon Blueprint Medicines unresectable/metastatic 18 mutation, including Ayvakit (avapritinib ) Kinase inhibitor Full Part D Gastrointestinal Stromal Corp. PDGFRA mutation-positive PDGFRA D842V Tumor disease mutations Deciphera Qinlock® (ripretinib ) 4th-line therapy Kinase inhibitor None Full Part D Pharmaceuticals Genentech/Blueprint Metastatic RET fusion-positive Presence of a RET gene Gavreto® (pralsetinib ) Kinase inhibitor Accelerated Part D Medicines disease fusion Presence of a RET gene fusion (FDA-approved Metastatic RET fusion-positive Lung Cancer, Non-Small Retevmo® (selpercatinib) Eli Lilly Kinase inhibitor test for the detection of Accelerated Part D disease Cell RET gene fusion not currently available) Presence of a mutation Metastatic disease positive for Tabrecta (capmatinib ) Novartis Kinase inhibitor that leads to MET exon Accelerated Part D MET exon 14 skipping 14 skipping. Metastatic small cell disease Lung Cancer, Small-Cell Zepzelca (lurbinectedin) Jazz Pharmaceuticals progressing on/after platinum- Alkylating agent None Accelerated Part B based chemo Genetically Tecartus (brexucabtagene Lymphoma, Mantle Cell KITE/Gilead Relapsed/refractory disease modified None Accelerated Part B autoleucel ) autologous t-cells Blenrep (belantamab Antibody-drug GlaxoSmithKline therapy for relapsed/refractory None Accelerated Part B mafodotin-blmf ) Conjugate Multiple Myeloma 3rd-line therapy after CD38-directed Sarclisa® (isatuximab-irfc) Sanofi lenalidomide and proteasome None Full Part B cytolitic antibody inhibitor Conjugate of nucleoside Inqovi® (decitabine, Myelodysplastic Syndrome Myelodysplastic Syndrome Taiho Oncology metabolic and None Full Part D cedaruzidine ) (subtypes) cytadine deaminase inhibitors

Relapsed/refractory high risk GD2-binding Neuroblastoma Danyelza® (namitamab-gqgk ) Y-mAbs Therapeutics disease in bone marrow which None Accelerated Part B antibody is responsive to prior therapy GnRH receptor Prostate Cancer Orgovyx (relugolix ) Myovant Sciences Advanced disease None Full Part D antagonist Genentech/Blueprint Presence of RET gene Gavreto® (pralsetinib ) Medicines Advanced or metastatic RET- mutation (FDA-approved Medullary Thyroid Cancer Kinase inhibitor Accelerated Part D mutant medullary disease test not currently Retevmo® (selpercatinib ) Eli Lilly available). Presence of a RET gene Genentech/Blueprint Advanced or metastatic RET Gavreto® (pralsetinib ) fusion (FDA-approved Thyroid Cancer Medicines fusion-positive patients who Kinase inhibitor Accelerated Part D test not currently (selpercatinib ) Eli Lilly are radio-iodone sensitive Retevmo® available)