Codes & NDC
| HCPCS | J9176 — "Injection, elotuzumab, 1 mg" (permanent) |
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| NDC 300 mg | 0003-3155-11 / 00003-3155-11 — N4 qualifier |
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| NDC 400 mg | 0003-3156-11 / 00003-3156-11 — N4 qualifier |
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| Vials | 300 mg & 400 mg lyophilized powder, single-dose — reconstitute with sterile water, dilute in NS or D5W |
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| FDA approval | 11/30/2015 (BLA 761035) — ERd; EPd added 11/6/2018 |
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| Benefit | Medical (provider buy-and-bill) |
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EPd vs ERd dosing — do not mix up
| Phase | EPd (+ pomalidomide + dex) | ERd (+ lenalidomide + dex) |
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| Loading | 10 mg/kg IV weekly × 8 doses (cycles 1–2) | 10 mg/kg IV weekly × 8 doses (cycles 1–2) |
| Maintenance | 20 mg/kg q4w (cycle 3+) | 10 mg/kg q2w (cycle 3+) |
| Indication | R/R MM ≥2 prior lines (incl. len + PI) | R/R MM 1–3 prior lines |
Top billing error: applying ERd interval to EPd dose (or vice-versa). Confirm regimen with prescribing oncologist before submitting.
Premedication (REQUIRED 45–90 min before each infusion)
- Dexamethasone 8 mg PO + 4 mg IV (in addition to combo regimen dex)
- Diphenhydramine 25–50 mg PO/IV (or equiv. H1 antihistamine)
- H2 blocker: famotidine 20 mg IV (label still cites ranitidine — withdrawn 2020, substitute famotidine)
- Acetaminophen 650–1,000 mg PO
Why required: ~10% infusion-reaction rate with first dose despite premed. Skipped premed = audit finding + clinical liability.
Administration & modifiers
| Code | When |
|---|
96413 | Chemo IV first hour (always billed) |
96415 | Each additional hour — needed during ramp-up loading doses |
96374 | IV push for IV premeds (dex, diphenhydramine, famotidine) |
96365 | Not appropriate — elotuzumab is chemo admin per CPT |
JZ vs JW: One must be on every claim. JZ = exact vial fit (e.g., 80 kg = 800 mg = 2 × 400). JW = wasted units on separate line (e.g., 65 kg = 650 mg drawn from 2 × 400 = 150 mg waste).
ICD-10 — multiple myeloma
| Code | For |
|---|
C90.00 | MM, NOS, not having achieved remission |
C90.01 | MM, in remission (maintenance phase) |
C90.02 | MM, in relapse (most common at initiation) |
C90.30 | NOT approved (solitary plasmacytoma) |
C88.0 | NOT approved (Waldenström's) |
PA needs more than ICD-10: submit prior-therapy summary — ERd needs 1–3 prior lines; EPd needs ≥2 prior lines including len + PI.
Vial math — common patient weights
| kg | 10 mg/kg | 20 mg/kg | Vials (10 mg/kg) | Mod |
|---|
| 60 | 600 | 1,200 | 2 × 300 | JZ |
| 65 | 650 | 1,300 | 2 × 400 (150 waste) | JW |
| 70 | 700 | 1,400 | 1 × 400 + 1 × 300 | JZ |
| 80 | 800 | 1,600 | 2 × 400 | JZ |
| 90 | 900 | 1,800 | 3 × 300 | JZ |
| 100 | 1,000 | 2,000 | 1 × 400 + 2 × 300 | JZ |
Payer requirements (May 2026)
| Payer | PA | Combo enforcement |
|---|
| UnitedHealthcare | Yes | Active IMiD prescription required; Optum site-of-care steering |
| Aetna | Yes | EPd or ERd combo + IMiD REMS confirmation |
| BCBS plans | Yes | Aligned w/ NCCN MM Guidelines + FDA combo definitions |
| Medicare Part B | No PA, MAC LCDs cover | Documentation only |
IMiD REMS is gating: Pomalyst REMS (EPd) or Lenalidomide REMS (ERd) must be active. Empliciti itself has no REMS.
Medicare reimbursement (Q4 2026)
| Field | Value |
|---|
| ASP + 6% | $8.188 / mg (effective 7/1 – 9/30/2026) |
| 800 mg loading dose (80 kg) | $6,550.40 (800 × $8.188) |
| 1,600 mg EPd maintenance (80 kg) | $13,100.80 (1,600 × $8.188) |
| Annual EPd at 80 kg | ~$200,000+ (8 loading + 12 maintenance) |
Site of care
| Setting | POS | Notes |
|---|
| Physician oncology office | 11 | Preferred after stable |
| Ambulatory infusion suite | 49 | Preferred after stable |
| Hospital outpatient (HOPD) | 22 / 19 | Often required during loading; disfavored later |
Patient assistance — BMS Access Support
- Phone: 1-800-861-0048 (BMS Access Support)
- Commercial copay: up to $25,000/year (Empliciti Co-Pay Assistance Program)
- PAP: free product for uninsured/underinsured (BMS Patient Assistance Foundation)
- IMiD partner: separate Pomalyst / Revlimid support — coordinate
- Foundations (Medicare): PAN, HealthWell, CancerCare, LLS
- Web: empliciti.com / bmsaccesssupport.com
M-PROTEIN INTERFERENCE — ALERT THE LAB: Elotuzumab is humanized IgGκ mAb. SPEP/IFE cannot reliably distinguish therapeutic antibody from native M-protein in IgGκ myeloma. Document lab notification — use HYDRASHIFT or mass-spec assays for response assessment. Confounded continuation requests are a top denial driver.