January 1, 2024
The following revisions were incorporated into the January 1, 2024 update.
Additions Reconstructive procedures and potentially cosmetic procedures Breast Reconstruction 19300 Genetically and bio-engineered skin substitutes for wound care Q4279 Q4287 Q4288 Q4289 Q4290 Q4291 Q4292 Q4293 Q4294 Q4295 Q4296 Q4297 Q4298 Q4299 Q4300 Q4301 Q4302 Q4303 Q4304 Prosthetics/orthoses Custom limb prosthetics including accessories/components L5615 L5926 Amyotrophic Lateral Sclerosis agents Debamestrocel (pending FDA approval) - J3490, J3590, and C9399 Antineoplastic agents Columvi™ - J9286 Elrexfio™ - C9165, J3490, and J3590 Epkinly™ - J9321 Pemfexy™ - J9258 Talvey™ - C9163, J3490, and J3590 Zolbetuximab (pending FDA approval) - J3490, J3590, and C9399 Anti PD-1/PD-L1 human monoclonal antibodies Camrelizumab (pending FDA approval) - J3490, J3590, and C9399 Cosibelimab (pending FDA approval) - J3490, J3590, and C9399 Zynyz™ - J9345 Enzyme replacement agents Apadamtase Alfa (pending FDA approval) – J3490, J3590, and C9399 Cinaxadamtase Alfa (pending FDA approval) – J3490, J3590, and C9399 Elfabrio® - J2508 Lamzede® - J0217 Gene Replacement / Gene Editing Therapies Casgevy™ - J3490, J3590, and C9399 Elevidys® - J1413 Fidanacogene Elaparvoec (pending FDA approval) - J3490, J3590, and C9399 Lyfgenia™- J3490, J3590, and C9399 Roctavian® - J1412 Vvjuvek™ - J3401 Multiple sclerosis agents Tyruko® - J3490, J3590, and C9399 Myasthemia Gravis Agents Rystiggo® - J9333 Vyvgart™ - J9332 Vyygart® Hytrulo - J9334 (The Specialty Drugs requiring precertification section entitled “Myasthemia Gravis Agents" is a new section effective January 1, 2024.) Ophthalmic agents Eylea® HD - J0178, J3590, and C9161 (Precertification requirements apply to all FDA-approved biosimilars to this reference product.) Tumor Infiltrating Lymphocyte (TIL) Therapy Lifileucel (pending FDA approval) – J3490, J3590, and C9399 (The Specialty Drugs requiring precertification section entitled “Tumor Infiltrating Lymphocyte (TIL) Therapy" is a new section effective January 1, 2024.) Miscellaneous therapeutic agents Lantidra® - J3490, J3590, and C9399
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Deletions
Prosthetics/orthoses Custom limb prosthetics including accessories/components K1014 K1022 Amyotrophic Lateral Sclerosis agents Radicava™ - J1301 Qalsody™– J3490, J3590, and C9399 Antineoplastic agents Alimta® - J9305 Epkinly™ - C9155 Kanjinti™ - Q5117 Lumoxiti™ - J9313 Mvasi™ - Q5107 (Note: Ophthalmologic use of Mvasi does not require precertification.) Oportuzumab Monatox (pending FDA approval) - J3490, J3590, and C9399 Pemetrexed - J9322, J9323 Pemfexy™ - J9304, J9314, J9294, J9296, J9297 Ruxience™ - Q5119 SH-111 (pending FDA approval) - J3490, J3590, and C9399 Trazimera™ - Q5116 Truxima™ - Q5115 Zirabev™ - Q5118 (Note: Ophthalmologic use of Zirabev does not require precertification.) Zynyz™ - J9345 Anti PD-1/PD-L1 human monoclonal antibodies Balstilimab (pending FDA approval) - J3490, J3590, and C9399 Sintilimab (pending FDA approval) - J3490, J3590, and C9399 Zynyz™ - J3590 and C9399 Chemotherapy-induced nausea and vomiting (CINV) agents Sustol® - J1627 (The Specialty Drugs requiring precertification section entitled “Chemotherapy induced nausea and vomiting (CINV) agents" is removed effective January 1, 2024.) Endocrine/metabolic agents Cosyntropin depot (pending FDA approval) - J3490, J3590, and C9399 Makena® - J1726 and J1729 Enzyme replacement agents Lamzede® - J3590 Gene Replacement / Gene Editing Therapies Roctavian™ - J3590 and C9399 Vyjuvek™ - J3590 and C9399 Neutropenia Neulasta® - J2506 (Precertification requirements apply to all FDA-approved biosimilars to this reference product.) Neulasta Onpro™ - J2506 Nivestym™ - Q5110 Nyvepria™ - Q5122 Plinabulin (pending FDA approval) - J3490, J3590, and C9399 Ophthalmic agents Abicipar (pending FDA approval) - J3490, J3590, and C9399 Eylea® - J0178 (Precertification requirements apply to all FDA-approved biosimilars to this reference product.) Eylea® HD – J3590 and C9399 Pulmonary arterial hypertension Trevyent (pending FDA approval) - J3490 and C9399 Respiratory agents Tezspire™ - J2356 Miscellaneous therapeutic agents Donislecel (pending FDA approval) – J3490, J3590, and C9399 Vyvgart™ - J9332 Vyvgart® Hytrulo – J3590 and C9399
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