HCPCS
J9203
1 unit = 0.1 mg
Phase 1
Identify what you're billing
Confirm CD33+ status, indication (newly-dx induction vs R/R monotherapy), fractionated dose schedule, and that the order is the 2017 re-approved fractionated regimen — not the historical single-dose regimen.
Fractionated D1/D4/D7 vs historical single dose — disambiguation FDA label verified May 2026
Mylotarg has a complicated approval history. The current FDA-approved regimen is fractionated only. Single-dose 9 mg/m² orders should never reach the pharmacy.
| Attribute | Current (2017 re-approval) | Historical (2000-2010, withdrawn) |
|---|---|---|
| Schedule | 3 mg/m² on D1, D4, D7 (induction); 3 mg/m² D1 (consolidation) | 9 mg/m² single dose repeated q2 weeks |
| Per-dose cap | 4.5 mg (one vial) | No formal cap |
| Cumulative dose per cycle | ~9 mg/m² total over 3 fractionated doses | 9 mg/m² single dose |
| Pivotal trial(s) | ALFA-0701 (newly-dx adult); MyloFrance-1 (R/R) | SWOG S0106 (showed excess mortality vs 7+3 alone) |
| VOD risk | Reduced vs historical, but still BOXED warning — especially with subsequent HSCT | Substantially elevated; primary driver of 2010 withdrawal |
| FDA status | Approved (BLA 761060, September 1, 2017) | Withdrawn June 21, 2010 |
| Combo partner | Daunorubicin + cytarabine (newly-dx); monotherapy (R/R) | Monotherapy |
| Approved age range | ≥ 1 month (newly-dx combo); ≥ 2 years (R/R mono); adults all indications | Adults only |
| Approved indications | Newly-dx CD33+ AML + R/R CD33+ AML | R/R CD33+ AML in patients ≥ 60 |
The trap: Older order sets, legacy EHR favorites, and any "Mylotarg 9 mg/m²" reference
in clinical or pharmacy literature predates the 2010 withdrawal and the 2017 fractionated re-approval. The
current label is fractionated only. If a single 9 mg/m² dose order is received, do not dispense —
confirm with the ordering oncologist that the intent is the fractionated 3 mg/m² × 3 (D1/D4/D7)
regimen. Document the clarification in the chart.
Why the per-dose 4.5 mg vial cap matters for billing: The FDA label specifies that each
fractionated dose is capped at one 4.5 mg vial regardless of calculated BSA. For BSA > 1.5 m² (i.e.,
any 3 mg/m² calculation > 4.5 mg), the administered dose is 4.5 mg exact — the full vial is used
and JZ is the appropriate modifier. JW waste appears only at low BSA when the calculated
dose is < 4.5 mg and the remainder of the vial is discarded.
Cross-link: Besponsa / inotuzumab ozogamicin (J9229) — the other Pfizer calicheamicin ADC, but anti-CD22 for B-cell ALL not AML. Different target, different indication, different J-code.
Dosing matrix FDA label verified May 2026
All approved regimens use 3 mg/m² per dose capped at one 4.5 mg vial. Differences are in schedule (3 doses vs 1) and combination partner.
| Indication | Per-dose | Schedule | Combo partner | Cycles |
|---|---|---|---|---|
| Newly-dx CD33+ AML — induction (adults + peds ≥ 1 month) | 3 mg/m² (cap 4.5 mg) | D1, D4, D7 | Daunorubicin 60 mg/m² D1-D3 + cytarabine 200 mg/m² CIV D1-D7 | 1 induction |
| Newly-dx CD33+ AML — consolidation (adults + peds ≥ 1 month) | 3 mg/m² (cap 4.5 mg) | D1 only | Daunorubicin + cytarabine per consolidation regimen | Up to 2 consolidation cycles |
| R/R CD33+ AML — monotherapy (adults + peds ≥ 2 years) | 3 mg/m² (cap 4.5 mg) | D1, D4, D7 | Monotherapy | 1 induction course only |
4.5 mg per-dose cap is hard-coded into the label. Do NOT exceed 4.5 mg per dose regardless
of calculated BSA. For BSA > 1.5 m², the administered dose is exactly 4.5 mg (one full vial). Pharmacy
compounding records should document the BSA, calculated mg, and the 4.5 mg cap application. Cumulative course
exposure with this regimen is intentionally lower than the historical 9 mg/m² single-dose schedule.
Infusion timing — every dose
- Infuse over 2 hours via low-protein-binding 0.2-micron in-line PES filter.
- Pre-medicate 1 hour before infusion: acetaminophen 650 mg PO + diphenhydramine 50 mg IV/PO + a corticosteroid (e.g., methylprednisolone or hydrocortisone) to reduce infusion-reaction risk.
- Bill
96413+96415× 1 for every dose (2-hour infusion exceeds the 1-hour 96413 window). - Slow or interrupt the infusion for any infusion-related reaction. Permanently discontinue for life-threatening reactions.
- Reconstituted solution: use within label-specified in-use stability times; refrigerate if held; protect from light.
Worked unit-math example — BSA 1.85 m² (high-BSA case, vial cap applies)
# Dose calculation
BSA 1.85 m² × 3 mg/m² = 5.55 mg calculated
Cap applied: 4.5 mg per dose (one full vial)
Administered: 4.5 mg — entire vial used, no waste
# Billing per dose (J9203 = 0.1 mg per unit)
4.5 mg / 0.1 mg = 45 units
Drug line: J9203 × 45 units with JZ modifier (exact, no waste)
Admin: 96413 × 1 + 96415 × 1 (2-hour infusion)
# Q2 2026 reimbursement per dose
45 units × $240.165/unit = ~$10,807.43 per dose
Induction (3 doses on D1/D4/D7) ≈ ~$32,422 drug only
Full course (induction + 2 consolidation doses) ≈ ~$54,037 drug only
BSA 1.85 m² × 3 mg/m² = 5.55 mg calculated
Cap applied: 4.5 mg per dose (one full vial)
Administered: 4.5 mg — entire vial used, no waste
# Billing per dose (J9203 = 0.1 mg per unit)
4.5 mg / 0.1 mg = 45 units
Drug line: J9203 × 45 units with JZ modifier (exact, no waste)
Admin: 96413 × 1 + 96415 × 1 (2-hour infusion)
# Q2 2026 reimbursement per dose
45 units × $240.165/unit = ~$10,807.43 per dose
Induction (3 doses on D1/D4/D7) ≈ ~$32,422 drug only
Full course (induction + 2 consolidation doses) ≈ ~$54,037 drug only
Worked unit-math example — BSA 1.3 m² (low-BSA case, JW waste)
# Dose calculation
BSA 1.3 m² × 3 mg/m² = 3.9 mg calculated
Below 4.5 mg cap — administer the calculated 3.9 mg
Vial: one 4.5 mg vial drawn → 0.6 mg discarded
# Billing per dose
Administered: 3.9 mg / 0.1 mg = 39 units
Waste: 0.6 mg / 0.1 mg = 6 units
Drug line 1: J9203 × 39 units with JZ modifier (administered)
Drug line 2: J9203 × 6 units with JW modifier (discarded)
Total billed: 45 units — same as the high-BSA case
# Q2 2026 reimbursement per dose
45 units × $240.165/unit = ~$10,807.43 per dose (admin + waste)
BSA 1.3 m² × 3 mg/m² = 3.9 mg calculated
Below 4.5 mg cap — administer the calculated 3.9 mg
Vial: one 4.5 mg vial drawn → 0.6 mg discarded
# Billing per dose
Administered: 3.9 mg / 0.1 mg = 39 units
Waste: 0.6 mg / 0.1 mg = 6 units
Drug line 1: J9203 × 39 units with JZ modifier (administered)
Drug line 2: J9203 × 6 units with JW modifier (discarded)
Total billed: 45 units — same as the high-BSA case
# Q2 2026 reimbursement per dose
45 units × $240.165/unit = ~$10,807.43 per dose (admin + waste)
JZ vs JW — the rule for Mylotarg: The 4.5 mg vial is the only Mylotarg vial size.
BSA > 1.5 m² (most adults) → calculated dose ≥ 4.5 mg → vial cap applies → full
vial administered → JZ exact, no JW waste line. BSA < 1.5 m² (most pediatrics,
smaller adults) → calculated dose < 4.5 mg → remainder of vial discarded → JZ on
administered line + separate JW line for the waste. One of JZ or JW must be on every J9203 claim
line since 7/1/2023.
NDC reference FDA NDC Directory + Pfizer 2026
| NDC (10/11-digit) | Strength | Package Size | Units/Vial |
|---|---|---|---|
0008-4510-01 / 00008-4510-01 |
4.5 mg | Single-dose vial; 1 vial per carton | 45 units (1 unit = 0.1 mg) |
Reconstitution & stability:
- Reconstitute each 4.5 mg vial with 5 mL Sterile Water for Injection USP → 1 mg/mL concentration that delivers 4.5 mL (4.5 mg).
- Swirl gently — do NOT shake. Inspect for particulates and discoloration. Solution should be yellow.
- Withdraw the calculated dose volume and dilute in 0.9% Sodium Chloride Injection USP per the FDA label-specified volume. Protect the prepared infusion from light during preparation, storage, and administration.
- Use a low-protein-binding 0.2-micron in-line PES filter for IV administration.
- Refrigerate (2°C to 8°C / 36°F to 46°F) vials and store in the original carton to protect from light. DO NOT FREEZE.
- Use reconstituted / diluted solution within in-use stability times specified in the current FDA label.
Single-vial-size inventory. Mylotarg is supplied only as the 4.5 mg single-dose vial. There
is no smaller (e.g., 1 mg or 2 mg) vial option for low-BSA pediatric patients — the entire vial is drawn,
the calculated dose is administered, and the remainder is reportable JW waste. Document the BSA, calculated mg,
administered mg, and discarded mg in the pharmacy compounding record for every dose.
Phase 2
Code the claim
96413 + 96415 every dose (2-hour infusion). JZ on administered line; JW on waste line for low-BSA cases only.
Administration codes CPT verified May 2026
Mylotarg is billed as chemotherapy administration. The 2-hour infusion always exceeds the 96413 first-hour window, so 96415 is required on every dose.
| Code | Description | When to use |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | Primary code, every dose. Covers the first 1 hour of the 2-hour Mylotarg infusion. |
96415 |
Chemotherapy administration, IV infusion; each additional hour | Required on every dose — pair with 96413 to cover the full 2-hour infusion (1 unit of 96415 covers the second hour). |
96365 / 96366 |
Therapeutic IV infusion (non-chemo) | NOT appropriate. Mylotarg is an antibody-drug conjugate; CPT classifies ADC admin under chemo codes regardless of mechanism. Pays materially less and triggers downcode denial. |
| Pre-medication admin | 96365 (IV therapeutic), 96367 (sequential), 96368 (concurrent), 96372 (subcut/IM), 96375 (IV push) | For the required pre-meds (acetaminophen PO, diphenhydramine IV, corticosteroid). Code per route and overlap rules. |
| Combo chemo (induction) | Additional 96413 + 96415 as appropriate for cytarabine CIV; daunorubicin push 96409 |
For the 7+3 backbone administered alongside Mylotarg in the newly-dx indication. Use the sequential / concurrent rules per AMA / CPT. |
Why chemo admin for an ADC: CPT chemotherapy administration codes (96409–96425) apply
to complex monoclonal antibody and antibody-drug conjugate administration regardless of mechanism. Mylotarg
pays materially more under 96413 + 96415 than under 96365 therapeutic infusion, and the chemo-admin code
aligns with how every major payer expects ADC administration to be billed.
Modifiers CMS verified May 2026
JZ — on the administered-units line (vast majority of adult cases)
Effective July 1, 2023, CMS requires either JZ (no waste) or JW (waste) on every single-dose container claim. Mylotarg ships only as a 4.5 mg single-dose vial. For any patient with BSA > 1.5 m² (most adults), the 3 mg/m² calculation exceeds 4.5 mg, the 4.5 mg per-dose vial cap applies, and the entire vial is administered — bill J9203 × 45 units with JZ. No JW line is needed (no waste).
JW — required only when BSA < 1.5 m² and the full vial is not used
For patients with BSA < 1.5 m² (smaller adults and most pediatric patients), the calculated 3 mg/m² dose is < 4.5 mg. The full 4.5 mg vial is still drawn (the only available presentation), the calculated dose is administered, and the remainder is discarded. Bill the discarded portion on a separate J9203 claim line with the JW modifier. Example: BSA 1.3 m² → 3.9 mg administered (39 units JZ) + 0.6 mg discarded (6 units JW).
Worked modifier example (BSA 1.85, high-BSA / typical adult)
- Drug line 1 (administered):
J9203× 45 units withJZmodifier (entire 4.5 mg vial, vial cap applied) - No JW line needed
- Admin:
96413× 1 +96415× 1 (2-hour infusion) - Pre-medication admin codes per route
Worked modifier example (BSA 1.3, low-BSA / pediatric)
- Drug line 1 (administered):
J9203× 39 units withJZmodifier - Drug line 2 (waste):
J9203× 6 units withJWmodifier - Admin:
96413× 1 +96415× 1 (2-hour infusion) - Total billed: 45 units per dose — same as high-BSA case (one full vial)
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 (e.g., a VOD assessment, baseline LFT review, or treatment-plan modification). Routine pre-infusion clinical assessment is bundled into the admin code.
340B modifiers (JG, TB)
For 340B-acquired Mylotarg, follow your MAC's current 340B modifier policy. Hospital outpatient claims under the OPPS 340B payment policy require the appropriate JG or TB modifier per CMS instructions and your hospital's 340B program participation.
Common error: Forgetting that the 4.5 mg cap turns most adult dosing into a JZ-exact case
(no JW). Billers familiar with weight-based antibody / ADC dosing may default to expecting a JW waste line.
For Mylotarg, JW is only present when the calculated dose is below 4.5 mg (low BSA). Document the BSA,
calculated mg, and applied vial cap in the pharmacy compounding record for every dose.
ICD-10-CM by indication FY2026 verified May 2026
All Mylotarg indications are CD33+ AML. Use the C92.0x series for AML and code the disease state (newly-diagnosed in remission, relapse, refractory) with the appropriate 5th digit.
| Indication / scenario | ICD-10 | Notes |
|---|---|---|
| Acute myeloblastic leukemia, NOT having achieved remission (newly-diagnosed, pre-induction) | C92.00 |
Primary code for newly-dx AML at induction; used when the patient has not yet achieved remission. Pair with Z51.11. |
| Acute myeloblastic leukemia, in remission (consolidation phase) | C92.01 |
Used for consolidation cycles after successful induction. Required for the 2 consolidation Mylotarg doses in the newly-dx regimen. |
| Acute myeloblastic leukemia, in relapse (R/R indication) | C92.02 |
Primary code for the R/R monotherapy indication (D1/D4/D7 single induction course). |
| Other AML subtypes (where applicable) | C92.4-C92.6, C92.A, C92.Z |
Some payers may require the more specific AML subtype code if documented in pathology (e.g., AML with maturation, acute monoblastic, etc.). Confirm coverage extends to the specific subtype on the path report. |
| Encounter for antineoplastic chemotherapy | Z51.11 |
Primary encounter code on the day of infusion, paired with the C92.0x code. |
| Encounter for antineoplastic immunotherapy | Z51.12 |
Some payers prefer Z51.12 for ADCs — verify per payer guidance. Most still accept Z51.11. |
| Aftercare following stem-cell transplant (post-HSCT VOD monitoring scenarios) | Z48.290 |
Used for the post-HSCT monitoring encounter type when applicable. Not used to support the Mylotarg drug claim itself. |
CD33+ status is the gate, but it lives in pathology — not ICD-10. The ICD-10 code alone
does not establish CD33-positivity. Every Mylotarg PA must include the flow cytometry or IHC report explicitly
documenting "CD33-positive" on the diagnostic blast population (bone marrow or peripheral blood). There is no
FDA-mandated CD33 expression threshold on the current label, but payer review staff will look for the
qualitative call. PA submitted without a CD33 result on file is the single most common Mylotarg denial reason.
Newly-diagnosed vs R/R documentation: Payer review staff routinely check that the disease
state on the PA matches the requested regimen.
C92.00 (not in remission, pre-induction) supports
the newly-dx fractionated D1/D4/D7 induction combination. C92.01 (in remission) supports the
consolidation doses. C92.02 (in relapse) supports the R/R monotherapy course. A PA narrative for
an R/R patient with a C92.00 code on the claim will trigger a clinical review.
Site of care & place of service Verified May 2026
Mylotarg is an AML induction / consolidation chemotherapy with significant infusion-reaction risk and a boxed warning for hepatotoxicity / VOD. Induction is typically delivered in the hospital outpatient department (HOPD) or an inpatient setting alongside the 7+3 backbone (continuous-infusion cytarabine + push daunorubicin). Consolidation can sometimes shift to a high-acuity oncology office or AIC for the single D1 Mylotarg dose, but the supportive-care infrastructure requirements typically keep care in HOPD. Home infusion is NOT appropriate — the CD33+ ADC monitoring requirements (LFTs before each dose, VOD surveillance, infusion-reaction monitoring) make supervised hospital-affiliated settings the standard.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Preferred for induction (combination chemo backbone + monitoring) |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Acceptable for consolidation; less common for induction |
| Inpatient | 21 | UB-04 / 837I | Common for induction when the 7+3 backbone keeps the patient admitted. Mylotarg billing folds into the inpatient claim per the inpatient DRG, not separately as Part B. |
| Physician oncology office | 11 | CMS-1500 / 837P | Possible for consolidation only; uncommon for induction due to combo-chemo requirements |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Possible for consolidation; not for induction |
| Oncology ASC | 24 | CMS-1500 / 837P | Limited — AML induction is rarely ASC-appropriate |
| Patient home | 12 | CMS-1500 (with home infusion) | Not appropriate — CD33+ ADC monitoring (LFTs, VOD surveillance, infusion reactions) requires supervised hospital-affiliated setting |
Inpatient billing note: When Mylotarg is administered to an inpatient as part of the 7+3+GO
induction regimen, the drug cost rolls into the inpatient DRG payment (typically MS-DRG 834-836 for AML with
major / non-major complications). It is not separately billable to Medicare Part B in the inpatient setting.
Outpatient consolidation doses are billed under OPPS to Part B with J9203 as outlined on this page.
Claim form field mapping Pfizer Oncology Together 2026
From Pfizer Oncology Together coding & coverage materials. Most Mylotarg administration is OPPS UB-04 (HOPD); CMS-1500 mapping shown below for consolidation in office / AIC.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 11-digit carton NDC 00008-4510-01 + ML + total reconstituted volume drawn (typically 4.5 mL for full vial use) |
| HCPCS J9203 + JZ (administered units) | 24D (drug line 1) | Administered units (1 unit = 0.1 mg). 45 units for full-vial use; less for low-BSA pediatric. |
| HCPCS J9203 + JW (waste units, low-BSA only) | 24D (drug line 2) | Discarded units when BSA < 1.5 m². Not present for most adult cases. |
| Drug units | 24G | Per line: administered units (line 1), waste units (line 2 when applicable) |
| CPT 96413 (admin line) | 24D | First hour, every dose |
| CPT 96415 (admin line) | 24D | Each additional hour — 1 unit on every Mylotarg dose (2-hour infusion) |
| ICD-10 | 21 | C92.00 (newly-dx induction), C92.01 (consolidation), or C92.02 (R/R) + Z51.11 / Z51.12 |
| CD33 flow / IHC test claim line (separate, when first done) | 24D | CPT 88184 / 88185 / 88187 / 88188 / 88189 (flow cytometry) and/or 88342 / 88341 (IHC) — per lab methodology |
| PA number | 23 | Required by most commercial payers; Medicare typically does not require PA for inpatient AML chemotherapy |
UB-04 specifics for HOPD: Hospital outpatient claims use revenue codes 0335 / 0636 for
chemotherapy drug + administration. Most major MACs accept the J9203 + JZ / JW pattern on UB-04 the same
way it appears on CMS-1500. Verify with your MAC and clearinghouse if your hospital uses a different
revenue-code mapping for ADCs.
Phase 3
Get paid
CD33+ flow / IHC report on file, baseline LFTs + bilirubin, and explicit fractionated-dose schedule documentation are the make-or-break PA elements.
Payer policy snapshot Reviewed May 2026
All major payers require CD33+ documentation, the fractionated D1/D4/D7 schedule (not the historical single-dose regimen), and baseline hepatic function. Pediatric AML PAs require explicit age documentation.
| Payer | PA? | Biomarker / clinical enforcement | Site-of-care UM |
|---|---|---|---|
| UnitedHealthcare Oncology Med Coverage Policy |
Yes (commercial / MA) | Strict — CD33+ flow / IHC report required; fractionated D1/D4/D7 schedule documented; baseline LFTs + bilirubin | HOPD typical for induction; consolidation may steer to high-acuity office or AIC where feasible |
| Aetna Medical Drug Policy |
Yes | CD33+ confirmation; explicit indication (newly-dx vs R/R); peds requires age ≥ 1 month (newly-dx combo) or ≥ 2 years (R/R mono) | Site-of-Care policy applies; AML induction generally HOPD-accepted |
| BCBS plans Vary by plan |
Yes | Generally aligned with NCCN AML guideline + FDA label CD33+ requirement | Plan-specific; most accept HOPD induction |
| Medicare (MAC LCDs) All MACs |
Generally no PA under Original Medicare for on-label inpatient or HOPD AML chemotherapy | Coverage for FDA-approved on-label indications with appropriate ICD-10 (C92.0x) + CD33+ documentation | N/A (Original Medicare). MA plans may apply commercial-style UM. |
| Medicaid (state-by-state) | Yes (most states) | CD33+ + indication-matched documentation; pediatric age verification | Limited; state-specific |
CD33 biomarker test billing (separate from drug claim)
| Test | CPT | For Mylotarg |
|---|---|---|
| Flow cytometry, technical component (first marker) | 88184 | First flow marker in the AML diagnostic panel |
| Flow cytometry, technical component (each additional marker) | 88185 | Per additional marker (CD33, CD34, CD13, CD117, etc.) |
| Flow cytometry, professional interpretation | 88187 / 88188 / 88189 | Tiered by number of markers interpreted; required for the formal AML immunophenotype report |
| IHC, manual (per specimen) | 88342 | Alternative or supplemental CD33 confirmation by IHC when flow is unavailable / inconclusive |
| IHC, each additional single antibody (after primary) | 88341 | Additional IHC stains in the same specimen |
Step therapy / sequencing
For newly-diagnosed CD33+ AML, Mylotarg is added to the 7+3 backbone (daunorubicin + cytarabine) as a first-line option per the ALFA-0701 regimen. Most payers do not impose step therapy for the newly-dx combo indication beyond the CD33+ + fitness-for-intensive-chemo determination by the treating oncologist. For R/R CD33+ AML, payers may require documentation of prior AML induction and relapse / refractoriness; venetoclax-based regimens, FLT3 / IDH inhibitors (where mutation-applicable), or clinical-trial enrollment are alternative pathways and may be considered prior to or alongside Mylotarg monotherapy. Verify per payer policy in 2026.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter. J9203 unit basis = 0.1 mg.
Q2 2026 payment snapshot — J9203
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions · ASP updated quarterly by CMS — next update July 1, 2026 for Q3
ASP + 6%
$240.165
per 0.1 mg unit ($2,401.65 / mg)
4.5 mg dose (1 vial, vial cap applied)
$10,807.43
45 units × ASP+6%
Induction (3 doses D1/D4/D7, drug only)
$32,422.28
3 × 45 units × ASP+6%
Full-course cost (typical adult, drug only): Newly-dx induction (3 doses on D1/D4/D7) +
2 consolidation cycles (1 dose each on D1) = 5 doses of 4.5 mg = 225 units. At Q2 2026 ASP+6%:
~$54,037.13 for Mylotarg alone (before sequestration; excludes the 7+3 backbone and admin
codes). After ~2% sequestration: roughly $52,956 actual paid. R/R monotherapy is a single 3-dose induction
only ≈ ~$32,422.28 drug only.
Coverage
No NCD specific to gemtuzumab ozogamicin. Coverage falls under MAC LCDs for biologics and the generic drug-coverage framework. All MACs cover J9203 for FDA-approved on-label indications with appropriate ICD-10 and CD33+ documentation. Medicare Advantage plans may apply commercial-style PA and site-of-care UM. Inpatient administration during the 7+3+GO induction bundles into the inpatient DRG (typically AML with chemo MS-DRG group) and is not separately billed under Part B.
Code history
- J9203 — permanent code, "Injection, gemtuzumab ozogamicin, 0.1 mg" (active for the 2017 re-approval period; the original 2000-2010 marketing period used a different coding pattern under the prior label and was withdrawn from CMS pricing during the withdrawal years)
- FDA re-approval: September 1, 2017, BLA 761060, at the fractionated D1/D4/D7 dose only
Patient assistance — Pfizer Oncology Together Verified May 2026
- Pfizer Oncology Together (Mylotarg hub): 1-877-744-5675 (Mon–Fri, 8am–8pm ET) — benefits investigation, prior authorization assistance, appeal support, billing & coding hotline, copay enrollment
- Pfizer Oncology Together Co-Pay Savings Program: commercial copay support for eligible commercially-insured patients (excludes Medicare, Medicaid, federal program patients); enrollment via pfizeroncologytogether.com or HCP enrollment portal
- Pfizer Patient Assistance Program (PAP): free product for uninsured or under-insured patients meeting income requirements (typically ≤ 300% FPL for 2026 re-enrollment per Pfizer PAP guidance). Enrollment form fax: 1-877-736-6506. Mail: Pfizer Oncology Together, PO Box 220366, Charlotte, NC 28222-0366.
- Foundations for Medicare / federal-program patients: PAN Foundation (AML / leukemia fund), HealthWell Foundation, Leukemia & Lymphoma Society Co-Pay Assistance Program, CancerCare Co-Payment Assistance Foundation — verify open AML / leukemia funds quarterly
- Web: pfizeroncologytogether.com/hcp/enrollment · pfizertogether.com/patient/mylotarg · pfizermedical.com/mylotarg
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J9203 pre-loaded.
Phase 4
Fix problems
Missing CD33+ flow/IHC report, missing baseline LFTs + bilirubin, wrong dosing schedule (single 9 mg/m² instead of fractionated D1/D4/D7), and missing JW waste line for low-BSA pediatric cases are the top denials.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| CD33+ documentation not on file | PA submitted without flow cytometry or IHC report explicitly documenting CD33-positive blast population | Submit the flow cytometry immunophenotype report (or IHC report) showing "CD33-positive" on the diagnostic AML blasts. Schedule CD33 testing as part of the standard AML diagnostic flow panel BEFORE Mylotarg PA submission — this is the #1 cause of Mylotarg denials. |
| Missing baseline LFTs / bilirubin | Hepatotoxicity / VOD boxed warning not documented at baseline | Document baseline AST, ALT, alkaline phosphatase, and total bilirubin in the chart. Include per-dose LFTs and bilirubin for continuation reviews. Payer audits frequently flag missing per-dose LFT documentation on Mylotarg claims. |
| Wrong dosing schedule (single 9 mg/m²) | Order or PA referenced the historical 2000-era single-dose regimen instead of fractionated D1/D4/D7 | Re-issue the order at 3 mg/m² on D1, D4, and D7 (each dose capped at 4.5 mg). The current FDA label permits ONLY the fractionated schedule. Re-submit PA with the corrected regimen. |
| Newly-dx vs R/R indication mismatch | PA narrative describes R/R but ICD-10 = C92.00 (not in remission), or vice versa | Align ICD-10 to disease state: C92.00 for newly-dx induction, C92.01 for consolidation in remission, C92.02 for R/R. Re-submit with matched documentation. |
| Pediatric age not documented | Pediatric AML PA without explicit age confirmation | Document patient age in the PA narrative. Newly-dx combo: ≥ 1 month. R/R monotherapy: ≥ 2 years. Pediatric oncology payers will reject without age confirmation matched to indication. |
| Post-HSCT VOD monitoring not documented | Continuation / post-HSCT claim without VOD surveillance documentation | Document weight, abdominal exam, bilirubin, and signs/symptoms of VOD (RUQ pain, ascites, hepatomegaly) on post-Mylotarg or post-HSCT encounters. The VOD risk is dose-dependent and substantially elevated within 3 months of HSCT. |
| Wrong admin code (96365) | Therapeutic IV billed instead of chemo IV | Resubmit with 96413 + 96415. Mylotarg is chemo admin per CPT classification despite ADC mechanism. The 2-hour infusion requires both codes. |
| Missing 96415 (additional hour) | Only 96413 billed for a 2-hour infusion | Add 96415 × 1 to cover the second hour. Mylotarg infuses over 2 hours; 96415 is required on every dose. |
| JW waste line missing (low-BSA pediatric) | Discarded mg not reported when calculated dose < 4.5 mg (BSA < 1.5) | Add JW line for discarded units alongside the JZ line for administered units. Required since 7/1/2023 when any waste exists. |
| JZ/JW missing entirely | Single-dose vial claim without modifier | One of JZ or JW must be on every J9203 claim. For full-vial use (most adults), JZ alone is correct. For low-BSA cases, JZ on administered + JW on waste. Resubmit with appropriate modifiers. |
| Wrong NDC format | NDC submitted in wrong format (missing leading 0) | Use 11-digit format on the claim: 00008-4510-01. The 10-digit carton label NDC is 0008-4510-01 — payers require the leading 0 padded to 11 digits. |
| Dose exceeds 4.5 mg per fraction | Calculation did not apply per-dose vial cap | Per FDA label, do NOT exceed 4.5 mg per fractionated dose. For BSA > 1.5 m², administer exactly 4.5 mg (one full vial). Recalculate, document the cap application in pharmacy compounding record, and re-submit. |
Frequently asked questions
What is the HCPCS code for Mylotarg?
Mylotarg (gemtuzumab ozogamicin) is billed under HCPCS J9203 — "Injection, gemtuzumab
ozogamicin, 0.1 mg." Each 0.1 mg equals one billable unit (a 4.5 mg dose = 45 units). The drug ships as a
single 4.5 mg single-dose lyophilized vial (NDC 0008-4510-01). Dosing for newly-diagnosed CD33+
AML is fractionated: 3 mg/m² (capped at one 4.5 mg vial) on Days 1, 4, and 7 of induction in combination
with daunorubicin and cytarabine, then 3 mg/m² on Day 1 of each consolidation cycle.
Why is Mylotarg dosed on Days 1, 4, and 7 (fractionated dosing)?
Fractionated dosing is the entire reason Mylotarg is back on the market. The original 2000 FDA approval used a single 9 mg/m² dose and was associated with unacceptable rates of early death and veno-occlusive disease (VOD); the drug was voluntarily withdrawn in 2010. The ALFA-0701 (adult) and MyloFrance-1 (R/R) trials demonstrated that fractionating the dose into three lower doses of 3 mg/m² on D1/D4/D7 — each capped at a single 4.5 mg vial — preserved CD33 antibody saturation, improved event-free survival, and substantially reduced VOD risk. FDA re-approved Mylotarg in September 2017 at this fractionated dose only. Do NOT bill or administer a 9 mg/m² single dose — that is an off-label, historically dangerous regimen.
Is CD33 testing required for Mylotarg?
Yes. Mylotarg is approved only for CD33-positive AML. Confirm CD33 expression by flow cytometry or immunohistochemistry (IHC) on the diagnostic bone marrow or peripheral blood blast population BEFORE prior authorization is submitted. Most AML cases (~85-90%) are CD33+, but documented CD33 status on the pathology / flow report is the single most common payer-required PA element and the #1 reason Mylotarg PAs are denied for missing documentation. There is no FDA-mandated CD33 expression threshold (e.g., "20%" cutoff) on the current label, but payer policies often look for the qualitative "CD33-positive" call in the flow / IHC report.
Why was Mylotarg withdrawn in 2010 and then re-approved in 2017?
Mylotarg was first FDA-approved in May 2000 under accelerated approval for relapsed CD33+ AML at a single 9 mg/m² dose. The confirmatory SWOG S0106 trial showed higher induction mortality with Mylotarg added to 7+3 chemotherapy and no overall survival benefit, and Pfizer voluntarily withdrew the drug in June 2010. Subsequent investigator-initiated trials (ALFA-0701 in newly-diagnosed adult AML and MyloFrance-1 in relapsed / refractory AML) demonstrated efficacy and acceptable safety with a fractionated 3 mg/m² × 3 (D1/D4/D7) regimen instead of the original single-dose schedule. Based on those data, FDA re-approved Mylotarg on September 1, 2017 for newly-diagnosed CD33+ AML (adults and pediatric ≥ 1 month) and for R/R CD33+ AML (adults and pediatric ≥ 2 years), at the fractionated dose only.
What VOD / hepatotoxicity monitoring does Mylotarg require?
Mylotarg carries a BOXED WARNING for hepatotoxicity, including severe or fatal hepatic veno-occlusive disease / sinusoidal obstruction syndrome (VOD / SOS). Per FDA label: assess liver enzymes and total bilirubin before each Mylotarg dose; monitor for signs and symptoms of VOD (rapid weight gain, right upper-quadrant pain, hepatomegaly, ascites, elevated bilirubin) more frequently in patients who proceed to hematopoietic stem cell transplant (HSCT). VOD risk is dose-dependent and substantially elevated in patients who receive HSCT within 3 months of Mylotarg. Document baseline LFTs and bilirubin in the chart; payer audits and continuation reviews look for per-dose LFTs. Hold or permanently discontinue per label thresholds for transaminase or bilirubin elevations.
Is Mylotarg approved for pediatric AML?
Yes. Mylotarg is approved for newly-diagnosed CD33+ AML in pediatric patients aged 1 month and older (in combination with daunorubicin and cytarabine for induction, then with daunorubicin and cytarabine for consolidation), and for relapsed / refractory CD33+ AML in pediatric patients aged 2 years and older (as a single agent). Dosing remains weight-and-BSA based at 3 mg/m² (capped at one 4.5 mg vial). Document age + indication + CD33 status on the PA — pediatric oncology payers will reject without explicit age confirmation.
How is induction vs consolidation dosing different for Mylotarg?
For newly-diagnosed CD33+ AML in combination chemotherapy: INDUCTION dosing is 3 mg/m² (capped at one 4.5 mg vial) on Days 1, 4, and 7, combined with daunorubicin (60 mg/m² on D1/D2/D3) and cytarabine (200 mg/m² continuous infusion on D1-D7) — the modified "3+7+GO" regimen. CONSOLIDATION dosing is 3 mg/m² (capped at one 4.5 mg vial) on Day 1 only of each consolidation cycle, combined with daunorubicin and cytarabine (up to 2 consolidation cycles per the ALFA-0701 regimen). For R/R CD33+ AML monotherapy, Mylotarg is 3 mg/m² on D1, D4, and D7 of a single induction course only — there is no consolidation course in the R/R indication.
What CPT do I bill for Mylotarg infusion?
CPT 96413 (chemo IV, first hour) plus 96415 (each additional hour). Mylotarg is
infused over 2 hours, so bill 96413 + 96415 × 1 for every dose. Use an in-line
low-protein-binding 0.2-micron polyethersulfone (PES) filter. Pre-medicate with acetaminophen, diphenhydramine,
and a corticosteroid 1 hour before infusion to reduce infusion-reaction risk. Do NOT bill 96365
(therapeutic IV) — Mylotarg is an antibody-drug conjugate billed under chemotherapy administration codes
per CPT classification.
What is the Medicare reimbursement for J9203?
For Q2 2026, the Medicare Part B payment limit for J9203 is $240.165 per 0.1 mg unit (ASP + 6%) — which equals $2,401.65 per mg. A single 4.5 mg dose = 45 units = approximately $10,807.43 (before sequestration). A complete induction (3 fractionated doses of 4.5 mg on D1/D4/D7) reimburses approximately $32,422 for the drug alone. A typical full course (induction + 2 consolidation cycles of one 4.5 mg dose each) reimburses approximately $54,037 for Mylotarg. After ~2% sequestration, actual Medicare payment is approximately 2% lower. ASP is updated quarterly by CMS — next update July 1, 2026 for Q3.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- FDA — MYLOTARG (gemtuzumab ozogamicin) Prescribing Information (BLA 761060, re-approval September 1, 2017)
- DailyMed — MYLOTARG (gemtuzumab ozogamicin) PI
- Pfizer Medical Information — MYLOTARG HCP page (dosing, storage & handling, safety)
- Pfizer Press Release — FDA Approval of MYLOTARG (September 1, 2017)
- CMS — Medicare Part B Drug ASP Pricing File
- Castaigne et al., ALFA-0701: Effect of gemtuzumab ozogamicin on survival of adult patients with de novo AML (Lancet 2012)
- Taksin et al., MyloFrance-1: high efficacy and safety profile of fractionated doses of GO as induction therapy in relapsed AML
- NCCN Clinical Practice Guidelines — Acute Myeloid Leukemia (CD33+ Mylotarg-containing regimens)
- Pfizer Oncology Together — HCP Enrollment (Mylotarg PAP)
- Pfizer Oncology Together — Mylotarg Patient Financial Assistance
- UnitedHealthcare — Oncology Medication Clinical Coverage Policy
- FDA National Drug Code Directory
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. Mylotarg's current FDA label has been stable since the September 2017 re-approval; the most dynamic content on this page is the per-quarter ASP value and the payer-policy details around CD33 documentation and post-HSCT VOD monitoring.
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) including CD33 documentation requirements | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules + CD33 biomarker test codes | Annual | Reviewed against CMS HCPCS quarterly files, AMA CPT releases. |
| NDC, dosing, FDA label, indication list, boxed warning text | Event-driven | Tied to Pfizer document version + FDA label revision date (current revision: September 2017 re-approval label). |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS, Pfizer,
ALFA-0701, MyloFrance-1, payer 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 —
especially the fractionated dosing schedule, the per-dose 4.5 mg vial cap, the VOD monitoring requirements,
and the CD33+ documentation requirements that drive PA approval.
Change log
- — Initial publication. ASP data: Q2 2026 ($240.165 / 0.1 mg unit). Manufacturer source: Pfizer Oncology Together 2026. FDA label: current revision (September 2017 re-approval at fractionated dose). Boxed warning: hepatotoxicity / VOD / sinusoidal obstruction syndrome. Two approved indications: newly-dx CD33+ AML (adults + peds ≥ 1 month, combination) and R/R CD33+ AML (adults + peds ≥ 2 years, monotherapy). Heavy emphasis on fractionated D1/D4/D7 vs historical single-dose regimen.
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, dosing, and boxed warning content are verified against the current FDA label revision. We do not paraphrase from billing-software vendor blogs.