Teplizumab-mzwv Injection, for Intravenous Use (Tzield™) HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines

Effective Dec. 1, 2022, Medicaid and NC Health Choice cover teplizumab-mzwv injection.

Effective with date of service Dec. 1, 2022, Medicaid and NC Health Choice programs cover teplizumab-mzwv injection, for intravenous use (Tzield™) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3590 - Unclassified biologics.

Strength/Package Size(s): Injection: 2 mg per 2 mL (1 mg/mL) single-dose vial

Indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.

Recommended Dose: Administer Tzield by intravenous infusion (over a minimum of 30 minutes), using a body surface area-based dosing, once daily for 14 consecutive days as follows: 

  • Day 1: 65 mcg/m² 
  • Day 2: 125 mcg/m² 
  • Day 3: 250 mcg/m² 
  • Day 4: 500 mcg/m² 
  • Days 5 through 14: 1,030 mcg/m² Do not administer two doses on the same day. See full prescribing information for further detail.

For Medicaid and NC Health Choice Billing

  • The ICD-10-CM diagnosis code(s) required for billing is/are: 
    • E10.10 - Type 1 diabetes mellitus with ketoacidosis without coma; 
    • E10.21 - Type 1 diabetes mellitus with diabetic nephropathy; 
    • E10.22 - Type 1 diabetes mellitus with diabetic chronic kidney disease; 
    • E10.29 - Type 1 diabetes mellitus with other diabetic kidney complication; 
    • E10.3211 - Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye; 
    • E10.3212 - Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye; 
    • E10.3213 - Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral; 
    • E10.3291 - Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye; 
    • E10.3292 - Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye; 
    • E10.3293 - Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral; 
    • E10.3311 - Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye; 
    • E10.3312 - Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye; 
    • E10.3313 - Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral; 
    • E10.3391 - Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye; 
    • E10.3392 - Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye; 
    • E10.3393 - Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral; 
    • E10.3411 - Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye; 
    • E10.3412 - Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye; 
    • E10.3413 - Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral; 
    • E10.3491 - Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye; 
    • E10.3492 - Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye; 
    • E10.3493 - Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral; 
    • E10.3511 - Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye; 
    • E10.3512 - Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye; 
    • E10.3513 - Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral; 
    • E10.3521 - Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye; 
    • E10.3522 - Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye; 
    • E10.3523 - Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral; 
    • E10.3531 - Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye; 
    • E10.3532 - Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye; 
    • E10.3533 - Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral; 
    • E10.3541 - Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye; 
    • E10.3542 - Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye; 
    • E10.3543 - Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral; 
    • E10.3551 - Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, right eye;
    • E10.3552 - Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, left eye;
    • E10.3553 - Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, bilateral; E10.3591 - Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye; 
    • E10.3592 - Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye; 
    • E10.3593 - Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral; 
    • E10.36 - Type 1 diabetes mellitus with diabetic cataract; 
    • E10.37X1 - Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye; 
    • E10.37X2 - Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye; 
    • E10.37X3 - Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral; 
    • E10.39 - Type 1 diabetes mellitus with other diabetic ophthalmic complication; 
    • E10.41 - Type 1 diabetes mellitus with diabetic mononeuropathy; 
    • E10.42 - Type 1 diabetes mellitus with diabetic polyneuropathy; 
    • E10.43 - Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathy; E10.44 - Type 1 diabetes mellitus with diabetic amyotrophy; 
    • E10.49 - Type 1 diabetes mellitus with other diabetic neurological complication; 
    • E10.51 - Type 1 diabetes mellitus with diabetic peripheral angiopathy without gangrene; 
    • E10.52 - Type 1 diabetes mellitus with diabetic peripheral angiopathy with gangrene; 
    • E10.59 - Type 1 diabetes mellitus with other circulatory complications; 
    • E10.610 - Type 1 diabetes mellitus with diabetic neuropathic arthropathy; 
    • E10.618 - Type 1 diabetes mellitus with other diabetic arthropathy; 
    • E10.620 - Type 1 diabetes mellitus with diabetic dermatitis; 
    • E10.621 - Type 1 diabetes mellitus with foot ulcer; 
    • E10.622 - Type 1 diabetes mellitus with other skin ulcer; 
    • E10.628 - Type 1 diabetes mellitus with other skin complications; 
    • E10.630 - Type 1 diabetes mellitus with periodontal disease; 
    • E10.638 - Type 1 diabetes mellitus with other oral complications; 
    • E10.649 - Type 1 diabetes mellitus with hypoglycemia without coma; 
    • E10.65 - Type 1 diabetes mellitus with hyperglycemia; 
    • E10.69 - Type 1 diabetes mellitus with other specified complication; 
    • E10.9 - Type 1 diabetes mellitus without complications; 
    • O24.011 - Pre-existing type 1 diabetes mellitus, in pregnancy, first trimester; 
    • O24.012 - Pre-existing type 1 diabetes mellitus, in pregnancy, second trimester; 
    • O24.013 - Pre-existing type 1 diabetes mellitus, in pregnancy, third trimester; 
    • O24.02 - Pre-existing type 1 diabetes mellitus, in childbirth; 
    • O24.03 - Pre-existing type 1 diabetes mellitus, in the puerperium
  • Providers must bill with HCPCS code: J3590 - Unclassified biologics
  • One Medicaid and NC Health Choice unit of coverage is: 1 mcg
  • The maximum reimbursement rate per unit is: $7.47900
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs is/are: 73650-0316-01, 73650-0316-10, 73650-0316-14
  • The NDC units should be reported as “UN1”
  • For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update and PADP Clinical Coverage Policy 1B, Attachment A, H.7 on Medicaid's website.
  • Providers shall bill their usual and customary charge for non-340B drugs
  • PADP reimburses for drugs billed for Medicaid and NC Health Choice beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the “UD” modifier on the drug detail.
  • The fee schedule for the PADP is available on Medicaid's PADP web page.

Contact

NCTracks Call Center: 800-688-6696

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