HCPCS
J9227
10 mg = 1 unit
Phase 1
Identify what you're billing
Confirm combo (Isa-Pd / Isa-Kd / Isa-VRd 1L), weight-based dose, and lab/blood-bank notification before first dose.
Anti-CD38 class comparison — Sarclisa vs Darzalex IV vs Darzalex Faspro SC FDA verified May 2026
Two anti-CD38 monoclonal antibodies, three billable products. Daratumumab has an SC option; isatuximab does not.
The anti-CD38 monoclonal antibody class for multiple myeloma currently has two molecules (daratumumab and isatuximab) and three billable products. Daratumumab launched first (IV in 2015, SC formulation in 2020) and established the class. Isatuximab (Sarclisa) launched in 2020 as the second-to-market option and has remained IV-only.
| Sarclisa (IV) | Darzalex (IV) | Darzalex Faspro (SC) | |
|---|---|---|---|
| HCPCS | J9227 | J9145 | J9144 |
| Generic | isatuximab-irfc | daratumumab | daratumumab + hyaluronidase-fihj |
| Manufacturer | Sanofi | Janssen Biotech | Janssen Biotech |
| FDA approval | March 2020 (BLA 761113); IMROZ 1L Sept 2024 | November 2015 (BLA 761036) | May 2020 (BLA 761145) |
| Adult dose | 10 mg/kg IV (weight-based) | 16 mg/kg IV (weight-based) | 1,800 mg SC (fixed) |
| Administration time | ~3.5 hr first dose; 1.25–2.0 hr subsequent | 6–8 hr first dose; ≥3 hr subsequent | 3–5 minutes |
| Admin CPT | 96413 + 96415 (chemo IV) | 96413 + 96415 (chemo IV) | 96401 (chemo SC) |
| Q2 2026 ASP+6% (per 10 mg) | $83.577 | $70.774 | $55.032 |
| Indications | R/R MM (Isa-Pd, Isa-Kd); 1L transplant-ineligible (Isa-VRd, IMROZ 2024) | MM (NDMM + R/R, mono + combos); AL amyloidosis | MM (NDMM + R/R, mono + combos); AL amyloidosis |
| Always combination? | Yes (no monotherapy approval) | No (mono + combos) | No (mono + combos) |
| SPE/IFE M-protein interference | Yes (anti-CD38 class effect) | Yes (anti-CD38 class effect) | Yes (anti-CD38 class effect) |
| RBC type & screen interference | Yes (anti-CD38 class effect) | Yes (anti-CD38 class effect) | Yes (anti-CD38 class effect) |
Why Sarclisa exists alongside Darzalex: isatuximab and daratumumab bind different CD38 epitopes
and have somewhat different mechanisms (more direct apoptosis vs more ADCC for daratumumab). They are not
interchangeable in payer policy — switching mid-therapy requires a separate PA. Sarclisa first-infusion
time (~3.5 hr) is materially shorter than Darzalex IV first infusion (6–8 hr) but longer than Darzalex
Faspro SC (3–5 min).
Cross-reference pages:
Darzalex IV (J9145) ·
Darzalex Faspro SC (J9144) ·
Empliciti / elotuzumab (J9176) ·
Kyprolis / carfilzomib (J9047)
Dosing by combination regimen FDA label verified May 2026
Sarclisa is always given in combination — never monotherapy. Schedule depends on which combo and which line of therapy.
| Combo | Partners | Setting | Cycle 1 | Cycle 2+ | Maintenance |
|---|---|---|---|---|---|
| Isa-Pd | + pomalidomide + dexamethasone | R/R MM, ≥1 prior therapy (incl. lenalidomide + PI) | 10 mg/kg IV qw × 4 | 10 mg/kg IV q2wk | Continuous q2wk until progression |
| Isa-Kd | + carfilzomib + dexamethasone | R/R MM, 1–3 prior therapies | 10 mg/kg IV qw × 4 | 10 mg/kg IV q2wk | Continuous q2wk until progression |
| Isa-VRd NEW 2024 | + bortezomib + lenalidomide + dexamethasone | 1L NDMM, transplant-ineligible (IMROZ trial) | 10 mg/kg IV qw × 4 | 10 mg/kg IV q2wk × 4 cycles (Cycles 2–5) | q4wk with VRd from Cycle 6 onward |
IMROZ 1L approval was a billing-volume inflection point. Sarclisa is now appropriate for newly
diagnosed MM patients (transplant-ineligible) in the Isa-VRd quad regimen, which competes directly with the
Darzalex-VRd / Dara-VRd quads (D-RVd, D-VRd) used in the same setting. Watch for shifting payer preferences as
comparative data matures.
Concurrent PA on combo agents. Pomalidomide requires REMS (Pomalyst REMS), carfilzomib has its
own utilization management, and lenalidomide is on a Lenalidomide REMS. Coordinate Sarclisa PA with combo-agent
PAs — denials on the combo backbone often delay isatuximab starts.
Dose & unit math FDA label verified May 2026
Weight-based at 10 mg/kg. Vials are 100 mg and 500 mg single-dose.
Worked example — first-year billing for a 75 kg multiple myeloma patient on Isa-Pd
# Dose calc: 75 kg × 10 mg/kg = 750 mg per dose
Drug units billed per dose: 75 (J9227, 10 mg/unit)
Vial draw: 1 × 500 mg + 3 × 100 mg = 800 mg available; discard 50 mg
Bill: 75 units administered + 5 units JW waste
Admin: 96413 (1st hr) + 96415 × multiple add'l hrs
# Year-1 schedule for Isa-Pd or Isa-Kd (R/R MM)
Cycle 1 weekly: 4 doses
Cycle 2+ q2wk (~24 doses if continuous through Yr 1): ~24 doses
Total Yr-1 doses: ~28
Total Yr-1 drug units: 28 × 75 = 2,100
Total Yr-1 drug cost (Q2 2026 ASP+6%): ~$175,512 before sequestration
# Year-1 schedule for Isa-VRd (1L IMROZ)
Cycle 1 weekly: 4 doses
Cycles 2–5 q2wk: 8 doses
Cycle 6+ q4wk maintenance: ~7 doses
Total Yr-1 doses: ~19
Total Yr-1 drug cost: ~$119,098 at current ASP+6%
Drug units billed per dose: 75 (J9227, 10 mg/unit)
Vial draw: 1 × 500 mg + 3 × 100 mg = 800 mg available; discard 50 mg
Bill: 75 units administered + 5 units JW waste
Admin: 96413 (1st hr) + 96415 × multiple add'l hrs
# Year-1 schedule for Isa-Pd or Isa-Kd (R/R MM)
Cycle 1 weekly: 4 doses
Cycle 2+ q2wk (~24 doses if continuous through Yr 1): ~24 doses
Total Yr-1 doses: ~28
Total Yr-1 drug units: 28 × 75 = 2,100
Total Yr-1 drug cost (Q2 2026 ASP+6%): ~$175,512 before sequestration
# Year-1 schedule for Isa-VRd (1L IMROZ)
Cycle 1 weekly: 4 doses
Cycles 2–5 q2wk: 8 doses
Cycle 6+ q4wk maintenance: ~7 doses
Total Yr-1 doses: ~19
Total Yr-1 drug cost: ~$119,098 at current ASP+6%
Dose calc table by patient weight
| Patient weight | 10 mg/kg dose | J9227 units | Vial draw (typical) |
|---|---|---|---|
| 50 kg | 500 mg | 50 units | 1 × 500 mg = zero waste (JZ) |
| 60 kg | 600 mg | 60 units | 1 × 500 mg + 1 × 100 mg = zero waste (JZ) |
| 70 kg | 700 mg | 70 units | 1 × 500 mg + 2 × 100 mg = zero waste (JZ) |
| 75 kg | 750 mg | 75 units | 1 × 500 mg + 3 × 100 mg, discard 50 mg (JZ admin + JW 5 units) |
| 80 kg | 800 mg | 80 units | 1 × 500 mg + 3 × 100 mg = zero waste (JZ) |
| 90 kg | 900 mg | 90 units | 1 × 500 mg + 4 × 100 mg = zero waste (JZ) |
| 100 kg | 1,000 mg | 100 units | 2 × 500 mg = zero waste (JZ) |
Vial draw optimization: 500 mg + 100 mg vials make most weights draw cleanly. Weights ending
in odd 5s (e.g., 75, 85, 95 kg) typically generate JW waste. Always reconcile vials drawn vs. mg administered
for every J9227 claim and post the JW units explicitly.
NDC reference FDA NDC Directory verified May 2026
| NDC (10/11-digit) | Package | Use |
|---|---|---|
0024-5824-01 / 00024-5824-01 |
100 mg / 5 mL single-dose vial (20 mg/mL) | Smaller-dose patients, fine-tuning weight-based dose |
0024-5825-01 / 00024-5825-01 |
500 mg / 25 mL single-dose vial (20 mg/mL) | Workhorse vial — standard adult doses build from 500 mg vials |
Use the 11-digit NDC with N4 qualifier on CMS-1500 box 24A shaded line. Vial-only NDC is what
payers expect for single-dose vials. Format:
N4 00024582501 ML 25 for one 500 mg vial.
Premedication checklist FDA label requirement
All four premeds required 15–60 min before each Sarclisa infusion. First 4 infusions carry highest CRS / infusion reaction risk.
| Drug | Dose | Route | Timing | Notes |
|---|---|---|---|---|
| Acetaminophen | 650–1,000 mg | PO | 15–60 min pre | Antipyretic |
| Diphenhydramine | 25–50 mg | IV or PO | 15–60 min pre | Antihistamine; H1 blocker. IV preferred for first 4 infusions. |
| Methylprednisolone | 100 mg (or dex equivalent) | IV (or PO equivalent) | 15–60 min pre | Corticosteroid. Note: dex used as combo backbone may double-count; clarify per protocol. |
| Montelukast (optional) | 10 mg | PO | 15–60 min pre | Leukotriene receptor antagonist; reduces infusion reactions in some protocols. |
Infusion reactions are common (~38% during Cycle 1). Most reactions occur during the first
infusion. Have anaphylaxis emergency kit (epinephrine, additional steroids, oxygen) at bedside. Be prepared
to slow or interrupt infusion at first sign of reaction. After 4 well-tolerated infusions, premed regimen
may be lightened per FDA label.
Billing premeds: premeds bill under their own J-codes / CPTs — not bundled with
isatuximab. Use 96372 (IM/SC inj), 96374 (IV push), or 96365 (IV infusion of premed). Verify CPT hierarchy
rules for concurrent / sequential vs. initial admin codes.
M-protein interference (SPE / IFE) — notify the lab FDA label requirement
This is a clinical-monitoring gate that affects response classification. Anti-CD38 mAbs show up as a small monoclonal band on routine assays.
Isatuximab is an IgG kappa monoclonal antibody — it is detectable on serum protein
electrophoresis (SPE) and immunofixation (IFE). The drug itself can produce a small monoclonal band
in the gamma region that mimics residual M-protein, potentially confounding multiple myeloma response
assessment and miscategorizing complete response (CR) as VGPR. Same effect exists for daratumumab — this
is an anti-CD38 class effect.
Workflow
- Notify the clinical lab in writing that the patient is starting isatuximab. Most reference labs offer the IFE Hydrashift assay (Sebia) which uses an antibody that binds isatuximab to shift its mobility on the gel, separating drug from any residual patient M-protein.
- If Hydrashift is not available, the lab may report "anti-CD38 mAb interference present" on the IFE comment field; mass spectrometry (e.g., MALDI-TOF) can also distinguish drug from patient M-protein.
- Document the patient's pre-treatment M-protein isotype (e.g., IgG kappa) so the lab can flag the interference more accurately.
- This interference persists during therapy and for several months after the last dose.
Why this matters for the patient: a missed interference flag can lead to a "VGPR" classification
when the patient is actually in CR, which affects MRD-testing decisions, transplant referral, and clinical-trial
enrollment. This is a quality-of-care issue more than a billing issue, but billing-coding teams are often the
first to catch it because they see all the lab orders.
Type & screen workflow — before first dose FDA label requirement
Anti-CD38 mAbs interfere with pre-transfusion compatibility testing. Same precaution as Darzalex.
FDA label recommends baseline ABO/Rh typing and antibody screening BEFORE the first dose of isatuximab.
Like daratumumab, isatuximab binds CD38 on red blood cells and produces a positive indirect antiglobulin test
(Coombs) that masks underlying alloantibodies and interferes with crossmatching. Without a baseline T&S, the
blood bank cannot reliably establish compatibility for urgent transfusion later.
Workflow
- Order baseline ABO, Rh, and antibody screen before scheduling the first infusion (CPT 86900, 86901, 86850 — bill on the scheduling encounter)
- Notify the blood bank in writing that the patient is starting isatuximab. Most institutions add a problem-list flag noting "anti-CD38 mAb interference" so future T&S uses DTT-treated reagent cells or RBC genotyping
- Patient should carry a wallet card noting isatuximab use for ER scenarios at outside facilities
- Effect persists during therapy and for several months after the last dose
Other clinical prerequisites (verify before infusion)
- Hepatitis B screening (HBsAg + anti-HBc) per general anti-cancer mAb practice
- Pregnancy test for women of reproductive potential (combo pomalidomide / lenalidomide REMS)
- Baseline CBC + chemistry for neutropenia / thrombocytopenia monitoring (CBC with differential before each cycle)
- Pre-treatment M-protein isotype documentation to support lab interference flagging
Phase 2
Code the claim
Chemo admin codes apply — not therapeutic IV. Plan multiple 96415 units for the first 1–2 doses.
Administration codes CPT verified May 2026
Isatuximab is billed as chemotherapy administration despite being immunotherapy. First infusion ~3.5 hr means multiple 96415 units.
| Code | Description | When to use |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | Primary code for the first hour of every Sarclisa infusion. Bill x 1 per encounter. |
96415 |
Chemotherapy administration, IV infusion; each additional hour | Bill x N additional hours. First infusion ~3.5 hr = 2–3 units of 96415. Subsequent ~1.25–2.0 hr = 1 unit (if any). |
96365 / 96366 |
Therapeutic IV infusion (non-chemo) | NOT appropriate for isatuximab. CPT classifies complex monoclonal antibody administration under chemo codes (96409–96425) per AMA. |
| Premed admin codes | 96372 (IM/SC inj), 96374 (IV push), 96365 (IV infusion of premed) | Bill premed administration separately from chemo admin codes per CPT hierarchy rules. |
Typical infusion-time billing pattern
| Infusion # | Duration | 96413 | 96415 units |
|---|---|---|---|
| Cycle 1, Dose 1 (first ever) | ~3.5 hr | 1 | 2–3 |
| Cycle 1, Doses 2–4 | ~2.0 hr | 1 | 1 |
| Cycle 2+ (q2wk steady-state) | ~1.25–1.75 hr | 1 | 0–1 |
Faster than Darzalex IV: Sarclisa first infusion runs ~3.5 hr vs Darzalex IV first infusion at
6–8 hr. Steady-state Sarclisa runs 1.25–2.0 hr vs Darzalex IV at ≥3 hr. Fewer 96415 units billed
per encounter as a result.
Modifiers CMS verified May 2026
JZ — required when no waste
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. For Sarclisa, JZ applies whenever the dose draws cleanly from whole vials (e.g., 500 mg = 1 × 500 mg; 1,000 mg = 2 × 500 mg; 600 mg = 1 × 500 mg + 1 × 100 mg).
JW — required when waste exists
JW reports the discarded portion of a single-dose vial. Because Sarclisa dosing is weight-based, partial-vial waste is common at certain weights. Example: a 75 kg patient receives 750 mg (75 units). Optimal vial draw is 1 × 500 mg + 3 × 100 mg = 800 mg available; discard 50 mg. Bill 75 units of J9227 with JZ on the admin line AND a separate JW line for 5 units of waste. One of JZ or JW must be on every J9227 claim.
Common error: Forgetting the JW line on weight-based doses with partial-vial waste. CMS audits
flag this. Best practice: always reconcile vials drawn vs. mg administered for every J9227 claim and post the
JW units explicitly. Wasted drug is reimbursable but must be reported.
Modifier 25 — same-day E/M
Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the infusion. Routine pre-infusion clinical assessment is bundled.
340B modifiers (JG, TB)
For 340B-acquired isatuximab, follow your MAC's current 340B modifier policy. Sanofi does not provide 340B-specific instructions in the prescribing or billing materials.
ICD-10-CM by indication FY2026 verified May 2026
Use the most specific code supported by encounter documentation.
| Indication | ICD-10 family | Notes |
|---|---|---|
| Multiple myeloma, NOS | C90.00 | Without mention of remission — use for active disease |
| Multiple myeloma in remission | C90.01 | Maintenance / consolidation phase |
| Multiple myeloma in relapse | C90.02 | R/R MM — Isa-Pd or Isa-Kd combo |
| Encounter for antineoplastic immunotherapy | Z51.12 | Secondary code on encounter for the infusion |
| Personal hx of antineoplastic chemo | Z92.21 | Secondary code where appropriate |
Indication-specific PA criteria are the norm. For R/R MM (Isa-Pd or Isa-Kd), payers require
documentation of ≥1 prior MM therapy (often specifying lenalidomide + a proteasome inhibitor). For 1L
(Isa-VRd, IMROZ), payers require documentation of newly diagnosed status and transplant ineligibility (age,
comorbidity, performance status). ICD-10 alone is not sufficient for approval.
Site of care & place of service Verified May 2026
Sarclisa's faster infusion times (vs Darzalex IV) make it more compatible with standard infusion-suite scheduling, but commercial payers still apply general oncology site-of-care UM that disfavors HOPD after the first 3 months. Aetna's anti-CD38 site-of-care steering primarily targets Darzalex IV toward Faspro SC; for isatuximab (no SC option), the steering is HOPD → office/AIC.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Physician oncology office | 11 | CMS-1500 / 837P | Preferred by commercial UM |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Preferred by commercial UM |
| Oncology ASC | 24 | CMS-1500 / 837P | Acceptable |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Disfavored after first 3 months |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored after first 3 months |
| Patient home | 12 | CMS-1500 (with home infusion) | Rare for IV isatuximab |
Claim form field mapping Sanofi 2026
From Sanofi Patient Connection HCP coding & coverage materials.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 11-digit vial NDC + ML + total mL administered (e.g., 25 mL for one 500 mg vial) |
| HCPCS J9227 + JZ (or JW for waste) | 24D (drug line) | One of JZ / JW must be present on every claim |
| Drug units | 24G | mg administered ÷ 10 (e.g., 75 units for 750 mg) |
| CPT 96413 + 96415 (admin lines) | 24D (admin line(s)) | 96413 x 1 + 96415 x N additional hours |
| ICD-10 | 21 | C90.00 / C90.01 / C90.02 (MM) per documentation |
| Premed claim lines (separate) | 24D | J-codes for steroid/diphenhydramine/acetaminophen if billed separately; admin via 96372/96374/96365 |
| PA number | 23 | Required by all major commercial payers; not required by traditional Medicare for on-label use |
Phase 3
Get paid
PA universal for commercial. Medicare LCDs cover on-label. Sanofi Patient Connection has BI/PA support.
Payer policy snapshot Reviewed May 2026
All major commercial payers require PA. Concurrent PA on combo backbones (pomalidomide REMS, carfilzomib, lenalidomide REMS). Medicare LCDs cover all FDA-approved indications.
| Payer | PA? | Line of therapy / step | Notes |
|---|---|---|---|
| UnitedHealthcare Oncology Med Coverage Policy |
Yes for all MM indications | R/R: requires ≥1 prior MM therapy. 1L (Isa-VRd): requires transplant-ineligible status with documented criteria. | Concurrent PA on pomalidomide / carfilzomib / lenalidomide |
| Aetna Medical Drug + Site-of-Care policy |
Yes | R/R per FDA label; 1L Isa-VRd per FDA label | Site-of-care UM disfavors HOPD after 3 months; combo regimen documentation required |
| BCBS plans Vary by plan |
Yes | Aligned with NCCN MM guidelines + FDA label | Plan-specific; some plans review Sarclisa vs Darzalex preferred-product lists |
| Traditional Medicare MAC LCDs |
No (FFS); MA plans yes | Covers all FDA-approved indications with documentation | None for traditional FFS Medicare |
Documentation typically required for PA
- Confirmed multiple myeloma diagnosis (CRAB criteria or biomarker-positive)
- Line of therapy and prior regimens (with response and reason for discontinuation) — for R/R indications
- Transplant-ineligibility documentation — for 1L Isa-VRd
- Combo backbone specified (Isa-Pd, Isa-Kd, Isa-VRd) with concurrent PA on combo agents
- Type & screen baseline result (or scheduled)
- Performance status
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J9227
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$83.577
per 10 mg unit
750 mg dose (75 kg)
$6,268.28
75 units × ASP+6%
1,000 mg dose (100 kg)
$8,357.70
100 units × ASP+6%
Annualized cost (75 kg patient, Isa-Pd or Isa-Kd in R/R MM): Year 1 ~28 doses × 75 units
= 2,100 units ≈ $175,512/year (Medicare ASP+6%). Year 2+ continuous q2wk ≈
~$162,975/year. After ~2% sequestration, actual paid is roughly ~$172,000 (Yr 1).
Isa-VRd 1L (IMROZ): Year 1 ~19 doses ≈ $119,098/year; maintenance q4wk
thereafter ~13 doses ≈ ~$81,500/year.
Coverage
No NCD specific to isatuximab. Coverage falls under MAC LCDs for biologics + the generic anti-cancer drug-coverage framework. All MACs cover J9227 for FDA-approved on-label indications (R/R MM Isa-Pd / Isa-Kd, and 1L Isa-VRd per IMROZ approval) with appropriate ICD-10 and clinical documentation.
Code history
- J9227 — permanent code, effective January 1, 2021 (initial FDA approval was March 2020 for Isa-Pd; pre-permanent-code period used unclassified C9069 / J3590)
- September 2024: IMROZ 1L approval (Isa-VRd for newly diagnosed transplant-ineligible MM) added without J-code change
Patient assistance — Sanofi Patient Connection Sanofi verified May 2026
- Sanofi Patient Connection (Sarclisa): 1-833-930-6357 (Sarclisa-specific line) — benefits investigation, prior authorization assistance, appeal support, denials management
- Sanofi Patient Connection (general): 1-888-847-4877 (1-888-VITALPATH) — covers full Sanofi oncology portfolio
- Sarclisa Co-pay Program (commercial): eligible commercially-insured patients pay as little as $5 for the first dose with annual program limits (verify program limit and eligibility annually). Excludes Medicare, Medicaid, federal program patients.
- Sanofi Patient Assistance Foundation: free product for uninsured / underinsured patients meeting income / medical-need requirements
- Foundations for Medicare patients: refer to PAN Foundation (multiple myeloma fund), HealthWell, CancerCare, Leukemia & Lymphoma Society Co-Pay Program — verify open MM funds quarterly
- Web: sanoficares.us / sarclisa.com
Need to model what a specific patient will actually pay after Sanofi co-pay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J9227 pre-loaded.
Phase 4
Fix problems
Wrong admin code, missing JW on weight-based waste, missing baseline T&S, missing lab notification — the top four.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong admin code (96365) | Therapeutic IV billed instead of chemo IV | Resubmit with 96413 + 96415. Isatuximab is chemo admin per CPT classification despite being immunotherapy. |
| Insufficient 96415 hours billed | First infusion ~3.5 hr not captured (only 96413 billed) | Add 96415 x 2–3 for the first encounter. Document infusion start/stop times for audit defense. |
| JW missing on weight-based dose with waste | Wasted drug not reported on partial-vial draw (e.g., 75 kg = 50 mg waste) | Add JW line for discarded units. JW required since 1/1/2017; one of JZ/JW required since 7/1/2023. |
| JZ missing on adult claim | Single-dose vial claim without JZ when no waste | Resubmit with JZ. Required since 7/1/2023 on every claim with no waste. |
| Wrong NDC format | 10-digit NDC submitted; missing N4 qualifier or UoM | Use 11-digit NDC (00024-5824-01 or 00024-5825-01) with N4 + ML + total mL administered. |
| Site of care (HOPD) | HOPD administration after first 3 months on commercial plan with site-of-care UM | Move to office (POS 11) or AIC (POS 49); or document medical necessity for HOPD. |
| Indication-specific PA criteria not met | ICD-10 alone insufficient; line of therapy / transplant-ineligibility not documented | R/R: submit complete prior-regimen history. 1L: document transplant ineligibility (age, comorbidity, performance status). |
| Combo backbone PA denial | Pomalidomide / carfilzomib / lenalidomide PA not in place | Concurrent PA required — submit combo agent PAs alongside Sarclisa. Pomalidomide and lenalidomide require REMS enrollment. |
| Premed bundling denial | Premed admin codes denied as bundled | Verify CPT hierarchy: 96413 (chemo IV initial) is the primary; bill premed admin (96372 SC, 96374 IV push, or 96365 IV infusion) per CPT rules. |
Frequently asked questions
What is the HCPCS code for Sarclisa?
Sarclisa (isatuximab-irfc) is billed under HCPCS J9227 — "Injection, isatuximab-irfc,
10 mg." Each 10 mg equals one billable unit. Sarclisa is the second-to-market anti-CD38 monoclonal antibody
for multiple myeloma; the first-to-market is daratumumab (Darzalex IV J9145, Darzalex Faspro SC J9144).
Isatuximab is IV only — no SC formulation exists.
How many units of J9227 do I bill for a Sarclisa dose?
Calculate mg administered (10 mg/kg × patient weight in kg), then divide by 10. A 60 kg patient receives 600 mg = 60 units. A 75 kg patient receives 750 mg = 75 units. A 90 kg patient receives 900 mg = 90 units. Use JZ on every claim if the dose draws cleanly from whole vials with no waste; use JW for any discarded portion of a single-dose vial.
What administration CPT do I use for Sarclisa?
CPT 96413 (chemotherapy administration, IV infusion technique; up to 1 hour) for the first hour,
plus CPT 96415 (each additional hour) for subsequent hours. Isatuximab is classified as
chemotherapy admin per AMA guidelines for complex monoclonal antibody administration. First infusion runs ~3.5
hours; subsequent infusions 1.25–2.0 hours if tolerated. Plan multiple 96415 units for the first 1–2
doses.
Do I bill JZ or JW for Sarclisa?
Both modifiers can apply, depending on vial draw. Vials are 100 mg/5 mL and 500 mg/25 mL single-dose. A 1,000 mg dose (100 kg) draws from two 500 mg vials with zero waste (bill JZ on the 100 units administered). A 750 mg dose (75 kg) draws from one 500 mg + three 100 mg = 800 mg available, discards 50 mg (bill the admin line on 75 units AND JW on 5 units waste on a separate line). One of JZ or JW must be on every J9227 claim per CMS's July 2023 single-dose container policy.
What is the Medicare reimbursement for J9227?
For Q2 2026, the Medicare Part B payment limit for J9227 is $83.577 per 10 mg unit (ASP + 6%). A 750 mg dose for a 75 kg patient (75 units) reimburses at approximately $6,268.28. Annualized cost is regimen-dependent: ~28 doses Year 1 for Isa-Pd / Isa-Kd ≈ $175,512 for a 75 kg patient at Medicare ASP+6%, before sequestration. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
Does Sarclisa interfere with multiple myeloma lab monitoring?
Yes. Isatuximab is an IgG kappa monoclonal antibody and can be detected on serum protein electrophoresis (SPE) and immunofixation (IFE), which are used to monitor M-protein response in multiple myeloma. The drug can mimic a small monoclonal band (false-positive M-spike), confounding response assessment and potentially leading to incorrect classification of complete response (CR) as VGPR. Notify the clinical lab that the patient is on Sarclisa so the lab can use the IFE Hydrashift assay or report the interference. The same interference exists for daratumumab — anti-CD38 mAb class effect.
Does Sarclisa interfere with blood bank type and screen?
Yes — like daratumumab, isatuximab binds CD38 on red blood cells and causes a positive indirect antiglobulin (Coombs) test, interfering with routine pre-transfusion compatibility testing. The FDA label recommends baseline ABO/Rh typing and antibody screening before the first dose. Notify the blood bank that the patient is on isatuximab so they can use DTT-treated reagent cells or RBC genotyping. Effect persists during therapy and for several months after the last dose.
What is the dosing schedule for Sarclisa?
All combinations are 10 mg/kg IV. Isa-Pd and Isa-Kd (R/R MM): weekly for Cycle 1 (4 doses), then every 2 weeks. Isa-VRd (newly diagnosed transplant-ineligible, IMROZ September 2024): weekly for Cycle 1 (4 doses), then every 2 weeks for Cycles 2–4 (8 doses), then every 4 weeks maintenance with VRd. The 1L IMROZ approval expanded Sarclisa from R/R-only into newly diagnosed patients — a major billing-volume expansion.
How does Sarclisa compare to Darzalex (daratumumab)?
Both are anti-CD38 monoclonal antibodies for multiple myeloma. Sarclisa (isatuximab-irfc, J9227) is IV-only at 10 mg/kg. Darzalex (daratumumab IV, J9145) is 16 mg/kg IV. Darzalex Faspro (daratumumab + hyaluronidase-fihj SC, J9144) is a fixed 1,800 mg SC dose over 3–5 minutes. Q2 2026 ASP+6%: Sarclisa $83.577/10 mg vs Darzalex IV $70.774/10 mg vs Darzalex Faspro $55.032/10 mg. Sarclisa first infusion (~3.5 hr) is faster than Darzalex IV first infusion (6–8 hr). Daratumumab has the SC option; isatuximab does not. Both have SPE/IFE interference and RBC typing interference. See side-by-side comparison.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- SARCLISA (isatuximab-irfc) Prescribing Information — Sanofi / FDA-approved label
- DailyMed — SARCLISA (isatuximab-irfc) label
- Sanofi Patient Connection — HCP coding & coverage
- Sarclisa Patient Co-pay Program
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — HCPCS J9227 reference
- UnitedHealthcare — Oncology Medication Clinical Coverage Policy
- Aetna Medical Drug Policy — Isatuximab (Sarclisa)
- NCCN Clinical Practice Guidelines — Multiple Myeloma
- FDA approval announcement — isatuximab-irfc IMROZ 1L (September 2024)
- FDA National Drug Code Directory
- AABB — Anti-CD38 mAb interference with pre-transfusion testing (technical bulletins)
About this page
We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.
Found an error? Email hello@carecostestimate.com.
Refresh cadence
| Element | Cadence | How it's refreshed |
|---|---|---|
| Medicare ASP pricing | Quarterly | Auto-bound to CareCost ASP layer; updates on CMS file release. |
| Payer policies (UHC, Aetna, BCBS) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules | Annual | Reviewed against CMS HCPCS quarterly files and AMA CPT releases. |
| NDC, dosing, FDA label, indication list | Event-driven | Tied to manufacturer document version + FDA label revision date. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA label including
IMROZ 1L approval, CMS ASP, Sanofi Patient Connection, AABB technical bulletins, payer policy documents
— all linked above). Editorial review in progress. Until that review
is complete, treat this as a draft reference and verify each cited source for high-stakes claims.
Change log
- — Initial publication. ASP data: Q2 2026 ($83.577/10 mg unit). Manufacturer source: Sanofi Patient Connection HCP materials. FDA label: most recent revision (BLA 761113), including IMROZ 1L approval (September 2024). Anti-CD38 class comparison vs Darzalex (J9145) and Darzalex Faspro (J9144) included.
Methodology
Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. Payer policies are read directly from each payer's published medical / pharmacy policy documents. Indication list and dosing are verified against the current FDA label revision (including the IMROZ 1L approval). Type-and-screen and SPE/IFE interference workflows follow AABB technical bulletins and Sebia / mass-spec lab guidance on anti-CD38 mAb interference. We do not paraphrase from billing-software vendor blogs.