HCPCS
J9144
10 mg = 1 unit
Phase 1
Identify what you're billing
Confirm the right code, dose, and NDC before building the claim.
SC vs. IV formulations — J9144 vs. J9145 FDA verified 2025
The single most common biller error on this drug. Every billing axis differs — including dose model.
Daratumumab has two FDA-approved formulations from Janssen Biotech: the original intravenous infusion (Darzalex, J9145, approved November 2015) and the newer subcutaneous injection (Darzalex Faspro, J9144, approved May 2020). Both treat the same multiple myeloma indications — but the SC formulation has an additional FDA approval for newly diagnosed AL amyloidosis (January 2021). They are not interchangeable for billing.
| Darzalex Faspro (SC) | Darzalex (IV) | |
|---|---|---|
| HCPCS | J9144 | J9145 |
| Unit basis | 10 mg = 1 unit | 10 mg = 1 unit |
| NDC | 57894-0502-01 | 57894-0502-05 (100 mg/5 mL); 57894-0502-20 (400 mg/20 mL) |
| Vial size | 1,800 mg + 30,000 U / 15 mL | 100 mg/5 mL or 400 mg/20 mL |
| Dose model | Fixed 1,800 mg (weight-independent) | Weight-based (16 mg/kg) |
| Typical billable units | 180 (always) | ~120–160 (varies by weight) |
| Administration CPT | 96401 (SC chemo) | 96413 + 96415 (IV chemo + add'l hours) |
| Time to administer | ~3–5 minutes (SC, abdomen) | 3–7 hours (first dose); ~3 hours subsequent |
| Total chair time per visit | ~30–45 minutes | 4–8 hours (first dose) |
| Premedication | Oral corticosteroid + antihistamine + acetaminophen | Same, but typically IV prior to infusion |
| Wastage modifier (JZ) | Required (single-dose vial) | Required (single-dose vial) |
| JW (waste) | Does not apply (full vial used) | Often applies (weight-based partial vial) |
| Q2 2026 ASP+6% | $55.032 / 10 mg unit | Higher per-unit (varies; see J9145 page) |
| AL amyloidosis indication | Yes (newly diagnosed, with VCd) | No |
| FDA approval | May 1, 2020 (BLA 761145) | November 16, 2015 (BLA 761036) |
Disambiguation rule of thumb: if the encounter note says "subcutaneous," "SC injection,"
"abdomen," "Faspro," or "3–5 minute injection," bill
J9144 at exactly 180 units.
If it says "infusion," "IV," "weight-based," or runs 3+ hours, bill J9145 at weight-calculated
units. The unit math is fundamentally different (180 fixed vs ~120–160 weight-based) — a wrong
code produces denials and significant billing variance.
This page covers the SC formulation (Faspro, J9144). For the IV reference, see Darzalex (J9145).
Dosing & unit math FDA label 2025
From FDA prescribing information (BLA 761145).
FDA-labeled dose (verbatim):
"1,800 mg of daratumumab and 30,000 units of hyaluronidase administered as a subcutaneous injection into the abdomen approximately 3 inches (7.5 cm) right or left of the navel over approximately 3 to 5 minutes."
- Fixed 1,800 mg dose — not weight-based. Same dose for a 50 kg or 120 kg patient.
- Schedule mirrors IV daratumumab: weekly weeks 1–8, every 2 weeks weeks 9–24, every 4 weeks thereafter (regimen-dependent).
- Site: abdomen only, ~3 inches (7.5 cm) right or left of the navel. Rotate sites between doses.
- Time per dose: ~3–5 minutes (the actual injection); total chair time ~30–45 min including pre/post observation.
- 10 mg = 1 unit: bill 180 units per dose. 1,800 mg ÷ 10 mg/unit = 180.
Worked example — first 8 weeks for newly diagnosed multiple myeloma (D-VRd)
# Weekly dosing, weeks 1–8 (8 doses)
Per dose: 180 units J9144 + JZ + 96401
8 weekly doses × 180 units = 1,440 units total
# Every 2 weeks, weeks 9–24 (8 doses)
Per dose: 180 units
8 doses × 180 = 1,440 units
# Every 4 weeks, weeks 25–52 (~7 doses)
Per dose: 180 units
7 doses × 180 = 1,260 units
# Year-1 total billed units: ~4,140 units (23 doses)
# Vials used year-1: 23 (1 per dose)
Per dose: 180 units J9144 + JZ + 96401
8 weekly doses × 180 units = 1,440 units total
# Every 2 weeks, weeks 9–24 (8 doses)
Per dose: 180 units
8 doses × 180 = 1,440 units
# Every 4 weeks, weeks 25–52 (~7 doses)
Per dose: 180 units
7 doses × 180 = 1,260 units
# Year-1 total billed units: ~4,140 units (23 doses)
# Vials used year-1: 23 (1 per dose)
Required premedication (label-mandated)
Administer 1–3 hours prior to each Darzalex Faspro injection:
- Corticosteroid: dexamethasone 20 mg PO or IV (regimen-dependent — lower in some maintenance regimens)
- Antipyretic: acetaminophen 650–1,000 mg PO
- Antihistamine: diphenhydramine 25–50 mg PO or IV
Post-injection: corticosteroid (e.g., methylprednisolone 20 mg PO) on the day after the injection for the first dose. Bill premedications separately if the practice supplies them.
NDC reference FDA NDC Directory verified May 2026
| NDC (10-digit) | NDC (11-digit, claim form) | Package | Manufacturer |
|---|---|---|---|
57894-502-01 |
57894-0502-01 |
1,800 mg daratumumab + 30,000 U hyaluronidase in 15 mL (120 mg/mL + 2,000 U/mL), single-dose vial | Janssen Biotech, Inc. |
11-digit NDC required on most claim forms. Pad the middle segment with a leading zero:
57894-0502-01. Use the
N4 qualifier in CMS-1500 Box 24A and UB-04 Box 43.
Canonical source: FDA National Drug Code Directory.
Phase 2
Code the claim
Build the line items: admin code, modifiers, ICD-10, site of care.
Administration codes CPT verified May 2026
Daratumumab is an oncology biologic — 96401 is the appropriate SC chemo admin code.
| Code | Description | When to use |
|---|---|---|
96401 |
Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic | Primary code. Daratumumab is a CD38-targeted oncology monoclonal antibody — chemo SC admin applies. This is the manufacturer-recommended and most-accepted code. |
96372 |
Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular | Fallback only. Some payers may default to 96372 for SC biologics; appeal with chemo-eligibility documentation if denied 96401. |
96413 / 96415 |
IV chemo administration codes | Do NOT use for J9144. These are for the IV formulation J9145 only. Wrong-route admin code is a frequent denial. |
96369–96371 |
SC infusion via pump (hour-based) | Do NOT use. Faspro's 3–5 minute single injection falls below the hour-based SC infusion threshold. |
Why 96401 (not 96372): CMS and AMA recognize chemo-administration codes for non-cytotoxic
oncology agents including monoclonal antibodies (rituximab, daratumumab, isatuximab, elotuzumab) when used
for cancer indications. Janssen CarePath and most national payers accept 96401 for J9144 in multiple myeloma
and AL amyloidosis treatment.
Known payer exceptions: a small number of regional plans (select BCBS plans, some MA plans)
have historically denied 96401 for SC monoclonals and required 96372 instead. Maintain a per-payer admin-code
crosswalk; default to 96401 and flip to 96372 only for plans known to deny.
Modifiers CMS verified May 2026
JZ — required, every claim
Effective July 1, 2023, CMS requires the JZ modifier on all claims for single-dose container drugs when no drug is discarded. Darzalex Faspro is supplied in an 1,800 mg single-dose vial used in full per fixed dose, with no remainder. JZ applies to every Faspro claim.
JW — does NOT apply
JW is for documenting the discarded portion of a single-dose vial. Because each Faspro dose uses the complete vial with zero remainder (the fixed 1,800 mg dose equals the full vial contents), there is no drug to discard and JW is not used. This is a key difference from IV J9145, where weight-based dosing routinely leaves a vial remainder requiring JW.
⚠️ Common error: Carrying over the JW modifier habit from J9145 (IV) onto
J9144 (SC) claims. JW with 0 units in the discarded field is a known denial trigger at several MACs. For
J9144, use JZ — never JW.
Modifier 25 — situational
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 injection (common in oncology visits with chemo planning).
340B modifiers (JG, TB)
For 340B-acquired Darzalex Faspro, follow your MAC's current 340B modifier policy. JG is the standard modifier for 340B-acquired drugs paid at ASP−22.5%; some MACs accept TB as the alternative (informational) 340B identifier. Verify your MAC's current policy — this changes with CMS rulemaking.
ICD-10-CM diagnosis codes Effective Oct 1, 2025
Multiple myeloma codes (C90.0x) plus AL amyloidosis (E85.81) — an indication unique to J9144.
Multiple myeloma (primary indication)
| ICD-10 | Description | Use for |
|---|---|---|
C90.00 | Multiple myeloma not having achieved remission | Newly diagnosed or active disease |
C90.01 | Multiple myeloma in remission | Maintenance therapy |
C90.02 | Multiple myeloma in relapse | Relapsed/refractory disease |
AL amyloidosis (J9144-only indication)
| ICD-10 | Description | Use for |
|---|---|---|
E85.81 | Light chain (AL) amyloidosis | Primary AL code. Newly diagnosed, used with bortezomib + cyclophosphamide + dexamethasone (D-VCd) |
E85.82 | Wild-type transthyretin-related (ATTR) amyloidosis | Not appropriate — J9144 is approved for AL only, not ATTR |
E85.89 | Other amyloidosis | Use with caution; payers may down-code unless AL-specific documentation present |
AL amyloidosis is unique to J9144: the IV formulation J9145 does NOT carry the AL
amyloidosis indication. If treating newly diagnosed AL amyloidosis, you must use J9144 (Faspro) —
not J9145. This is currently the only FDA-approved treatment for newly diagnosed AL amyloidosis.
Avoid the parent code C90 alone. Use the most specific subcode (C90.00, .01, or .02)
consistent with disease state. Many payers reject claims billed only with C90 (parent).
Site of care & place of service Verified May 2026
Darzalex Faspro's 3–5 minute injection time means it does not require a full infusion-suite slot, opening up site-of-care optimization that's not possible with IV daratumumab:
| Setting | POS | Claim form | Electronic |
|---|---|---|---|
| Physician/oncology office | 11 | CMS-1500 | 837P |
| Ambulatory infusion suite | 49 | CMS-1500 | 837P |
| Hospital outpatient | 19 or 22 | UB-04 / CMS-1450 | 837I |
| Patient home (limited; specialty oncology vendors) | 12 | CMS-1500 (with home-infusion HCPCS) | 837P |
Site-of-care steering is real and active: UnitedHealthcare, Aetna, Cigna, and several
regional Blues actively prefer Faspro (J9144) over IV Darzalex (J9145) when clinically appropriate, and
will steer hospital-outpatient patients to office-based or ambulatory settings. Some commercial plans
require step from IV to Faspro after the first cycle. Verify the plan's preferred-formulation policy
before initiating IV.
Type & screen requirement (BEFORE first dose) FDA label 2025
⚠️ Critical pre-dose step: Daratumumab binds to CD38 on red blood cells
and interferes with the indirect Coombs (antiglobulin) test, masking minor antibodies and producing
pan-reactive results. The FDA label requires baseline type, screen, and antibody identification
BEFORE the first dose of daratumumab (IV or SC).
Workflow
- Pre-Faspro: draw type and screen + complete antibody identification panel. Document baseline ABO/Rh and any clinically significant antibodies.
- During treatment: notify the blood bank of daratumumab use at every transfusion request. Persist the alert for up to 6 months after the last dose — daratumumab interference outlasts the dosing window.
- Patient ID card: Janssen provides patient wallet cards; encourage patients to carry one to disclose daratumumab status at any blood-bank encounter.
Bill the labs separately
The pre-Faspro type and screen + antibody panel are billed under standard pathology codes (e.g., 86900 ABO; 86901 Rh; 86850 antibody screen; 86870 antibody identification). These are not bundled into J9144 and are reimbursed under the lab fee schedule.
Claim form field mapping Janssen CarePath 2025
From Janssen Biotech "Coding & Reimbursement for Darzalex Faspro" (Janssen CarePath, 2025).
CMS-1500 / 837P (physician office, POS 11/49)
| Information | CMS-1500 box | Electronic loop / segment |
|---|---|---|
| NPI | 17b | 2310A/2420E/2310D — NM109 |
| Drug info (name, dose, NDC, route, amount, strength) | 19 | 2300 NTE/PWK |
| ICD-10 (C90.0x or E85.81) | 21 | 2300 HI01-2 |
| PA number | 23 | 2300 REF02 |
| Dates of service | 24A | 2400 DTP03 |
| HCPCS J9144 + NDC (N4) + admin CPT 96401 + JZ modifier | 24D | 2400 SV101 (each on its own line) |
| Units (180) | 24G | 2400 SV104 |
Form references: NUCC (CMS-1500).
Phase 3
Get paid
Payer requirements, Medicare reimbursement, and patient-side support.
Payer policy snapshot Reviewed May 2026
Major commercial payers cover both J9144 and J9145 — many actively prefer SC for site-of-care optimization.
| Payer | PA? | Prefers SC over IV? | Step from IV req'd? | SoC steering | Re-auth |
|---|---|---|---|---|---|
| UnitedHealthcare Daratumumab medical drug policy |
Yes | Yes (preferred) | No (Faspro is first-line) | Yes (steers to office) | 12 mo |
| Aetna CPB 0820 (oncology biologics) |
Yes | Yes (preferred) | Some plans require step IV→Faspro after cycle 1 | Yes | w/ documented response |
| Cigna Daratumumab coverage policy |
Yes | Yes (preferred) | No | Standard SoC policy | w/ documented response |
| Anthem / Carelon ING-CC-0067 (or successor) |
Yes | Often (regional variation) | No | Site-of-care UM applies | w/ response |
| BCBS (regional) Combined daratumumab policy |
Yes | Yes (most regions) | Varies by plan | Yes | w/ response |
Key finding: Most major commercial payers actively prefer Faspro (J9144) over
IV Darzalex (J9145). The driver is site-of-care economics — a 30-minute office visit beats
a 4–8 hour hospital outpatient infusion. PA is still required for both formulations, and clinical
criteria are largely shared (regimen, line of therapy, prior agents).
What's the same as IV Darzalex (J9145)
- Multiple myeloma indications covered (combinations and monotherapy)
- Combined PA criteria for clinical eligibility (regimen, line of therapy)
- Same C90.0x ICD-10 codes accepted
- Same combination regimens covered (D-Rd, D-VRd, D-Vd, D-VCd, D-Pd, etc.)
What's different from IV Darzalex (J9145)
- AL amyloidosis: J9144 only — J9145 has no AL indication. Newly diagnosed AL amyloidosis with D-VCd requires Faspro.
- Site-of-care preference: Faspro is preferred at most national payers; IV may require additional justification at HOPD POS 22.
- Step therapy direction: when payers impose it, the step is IV→Faspro (not the reverse).
- Wastage: JZ only on J9144 (full vial); JW often applies on J9145 (weight-based partial vial).
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J9144
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$55.032
per 10 mg unit
1,800 mg dose
$9,905.76
180 units × ASP+6%
After sequestration
~$9,708
~2% reduction (actual paid)
SC vs IV Medicare delta: Per 10 mg unit, Faspro (J9144) is reimbursed at $55.032 in Q2
2026 — lower than IV J9145. The fixed 1,800 mg dose (180 units) costs Medicare ~$9,906 per visit.
For a typical IV J9145 dose at 16 mg/kg in an 80 kg patient (1,280 mg = 128 units), per-dose Medicare
cost differs accordingly. Site-of-care savings are larger than drug-cost differences — the IV
route adds 96413 + multiple 96415 hours plus facility fees at HOPD.
Coverage
There is no NCD or LCD specific to daratumumab. Coverage falls under the generic drug coverage LCD framework (e.g., LCD L33394 at Novitas / First Coast). All MACs cover J9144 for FDA-approved on-label indications. NCCN-recommended off-label uses in multiple myeloma combinations are also generally covered (Medicare relies on NCCN Compendium for oncology off-label).
Code history
- C9069 — temporary code, post-FDA approval (2020)
- J9144 — permanent code, "Daratumumab, hyaluronidase-fihj, 10 mg"
Canonical code source: CMS HCPCS quarterly update file.
Patient assistance & copay support Janssen CarePath verified May 2026
- Janssen CarePath Savings Program — commercial patients only: $0 copay first dose, then up to ~$20,000/year in savings
- Johnson & Johnson Patient Assistance Foundation — free drug for uninsured patients and Medicare patients with documented hardship
- Patient Navigator: 1-877-CarePath / 1-877-227-3728 (M–F 8 a.m.–8 p.m. ET)
- Enrollment: janssencarepath.com · darzalex.com
- Independent foundations (for Medicare patients ineligible for J&J PAF): The Leukemia & Lymphoma Society Co-Pay Assistance Program, HealthWell Foundation (multiple myeloma fund), PAN Foundation, Patient Advocate Foundation Co-Pay Relief
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J-code pre-loaded.
Phase 4
Fix problems
When a claim denies or a question stalls, start here.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong J-code (J9145 instead of J9144) | SC dose billed under the IV J-code — or vice versa | Verify formulation in encounter notes. SC = J9144, fixed 180 units. IV = J9145, weight-based units (16 mg/kg). |
| Wrong unit count | Billing 1,800 units (mg) instead of 180 units (10 mg = 1 unit) | 1 unit = 10 mg. Fixed 1,800 mg dose = 180 units. Always. |
| Modifier denial (JW) | JW used instead of JZ (or both); JW carry-over from J9145 habit | Resubmit with JZ only. JW does not apply — full vial is administered with no waste. |
| Admin code denial (96413/96415) | IV chemo admin codes used on a SC injection | Resubmit with 96401 (SC chemo). Never bill IV admin codes for J9144. |
| Admin code denial (96401) | Payer doesn't recognize daratumumab as chemo-eligible | Appeal with chemo eligibility documentation; or resubmit with 96372 if payer has explicit non-chemo policy. |
| ICD-10 too broad | C90 (parent) used instead of C90.00, .01, or .02 | Use the most specific subcode consistent with disease state. |
| AL amyloidosis denied under J9145 | IV Darzalex billed for AL amyloidosis indication | AL amyloidosis is J9144-only. Switch to Faspro for the AL indication. |
| PA not on file | Initial dose given before authorization confirmed | Submit appeal with clinical documentation. Combined Darzalex + Faspro PA at most payers; check before each cycle. |
| NDC format | 10-digit NDC submitted; payer requires 11-digit | Use 11-digit form: 57894-0502-01 with N4 qualifier. |
| Type & screen not documented | Pre-Faspro labs not on file for first dose | Document baseline T&S + antibody panel before first dose. Some payers audit this; transfusion safety standard requires it. |
| Site-of-care denial (HOPD POS 22) | Faspro billed at hospital outpatient when payer requires office | Move to POS 11 (office) or 49 (ambulatory infusion) where contractually allowed; appeal with medical-necessity documentation. |
Frequently asked questions
What is the HCPCS code for Darzalex Faspro?
Darzalex Faspro (subcutaneous daratumumab + hyaluronidase-fihj) is billed under HCPCS
J9144 — "Daratumumab, hyaluronidase-fihj, 10 mg." Each 10 mg of daratumumab
equals one billable unit, so the standard 1,800 mg fixed dose is billed as 180 units. The intravenous
formulation (Darzalex) uses a separate code: J9145 — also 10 mg = 1 unit, but dosed
by weight (16 mg/kg).
How many units do I bill for an 1,800 mg dose of Darzalex Faspro?
Bill 180 units under J9144 for every Darzalex Faspro dose. 10 mg of
daratumumab = 1 unit. The dose is fixed at 1,800 mg SC regardless of patient weight, with a single
full-vial 15 mL subcutaneous injection over 3–5 minutes. 1,800 mg ÷ 10 mg/unit
= 180 billable units — always.
What administration CPT do I use for Darzalex Faspro?
The primary code is 96401 (chemotherapy administration, subcutaneous or intramuscular,
non-hormonal anti-neoplastic). Daratumumab is an oncology biologic, so 96401 is the appropriate
chemo SC admin code at most payers. Some payers accept 96372 (therapeutic SC injection)
as a fallback, but 96401 is more common and oncology-specific. Do not bill 96413 or
96415 — those are IV chemo codes for the J9145 IV formulation.
Does the JW modifier apply to Darzalex Faspro?
No. Darzalex Faspro is supplied in an 1,800 mg single-dose vial used in full for each fixed dose, with
no remainder. The JZ modifier (zero drug discarded) is required on every claim under CMS's
July 2023 single-dose container policy. JW does not apply because there is no drug discarded — the
entire vial is administered as the fixed 1,800 mg dose.
Is Darzalex Faspro billed differently from IV Darzalex?
Yes — every billing axis differs. J9144 vs J9145. Fixed 1,800 mg SC dose (180 units, weight-independent) vs weight-based IV dose (16 mg/kg, ~120–160 units for typical adult). 3–5 minute SC injection vs 3–7 hour IV infusion (first dose). Admin CPT 96401 (SC chemo) vs 96413 + 96415 (IV chemo with extended hours). JZ-only for J9144 vs JZ/JW for J9145. Wrong code = denial or significant billing error. Confirm formulation in encounter notes before billing.
What is the Medicare reimbursement for J9144?
For Q2 2026, the Medicare Part B payment limit for J9144 is $55.032 per 10 mg unit (ASP + 6%). The fixed 1,800 mg dose (180 units) is reimbursed at approximately $9,905.76 before sequestration. Sequestration (~2%) reduces the actual paid amount to roughly ASP + 4.3%. ASP is updated quarterly by CMS.
Do payers prefer Darzalex Faspro (SC) over IV Darzalex?
Yes — many major payers including UnitedHealthcare, Aetna, and Cigna often prefer the SC formulation (Faspro) over IV daratumumab for site-of-care optimization. The SC route reduces chair time from 3–7 hours to under 10 minutes total visit, lowering site-of-care costs. PA is still required, and some commercial plans require step from IV to Faspro after the first cycle when initiated on IV. Verify each plan's preferred-formulation policy before initiating IV.
Is Darzalex Faspro approved for AL amyloidosis?
Yes. Darzalex Faspro is FDA-approved for newly diagnosed light chain (AL) amyloidosis in combination
with bortezomib, cyclophosphamide, and dexamethasone (D-VCd regimen). This is currently the only
FDA-approved treatment for newly diagnosed AL amyloidosis. Use ICD-10 E85.81 (light chain
amyloidosis). The IV formulation J9145 does NOT carry the AL amyloidosis indication — only J9144
does.
Why does Darzalex Faspro require type and screen before the first dose?
Daratumumab binds to CD38 on red blood cells and interferes with indirect Coombs (antiglobulin) tests, masking minor antibodies and causing pan-reactive results. The FDA label requires baseline type, screen, and antibody identification BEFORE the first dose. Document the baseline ABO/Rh and antibody panel in the chart — this protects future transfusions for up to 6 months after the last daratumumab dose. Notify the blood bank of daratumumab use at every transfusion request.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- DailyMed — Darzalex Faspro (daratumumab and hyaluronidase-fihj) Prescribing Information
- FDA approval letter — Darzalex Faspro (BLA 761145)
- Janssen CarePath — Darzalex Faspro Coding & Billing Reference
- Darzalex / Darzalex Faspro — Janssen Biotech product site
- CMS — Medicare Part B Drug ASP Pricing File
- CMS — HCPCS quarterly update file (canonical J-code source)
- CMS LCD L33394 — Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
- FDA National Drug Code Directory
- NCCN Clinical Practice Guidelines in Oncology — Multiple Myeloma
- UnitedHealthcare Commercial Medical Benefit Drug Policy: Daratumumab (Darzalex / Darzalex Faspro)
- Aetna Clinical Policy Bulletin — Multiple Myeloma / Oncology Biologics
- Cigna Drug Coverage Policy — Daratumumab
- Janssen CarePath — Patient Support Program
About this page
We maintain this page as a living reference. The drug fact card and Medicare ASP pricing are bound to our underlying CareCost data layer and refresh 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, Cigna, Anthem) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules | Annual | Reviewed against CMS HCPCS quarterly update file and AMA CPT releases. |
| NDC, dosing, FDA label | Event-driven | Tied to manufacturer document version + FDA label revision date. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS,
manufacturer, 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.
Change log
- — Initial publication. ASP data: Q2 2026 (J9144 ASP+6% = $55.032 per 10 mg unit). Manufacturer source: Janssen CarePath 2025. FDA label: 2025 revision (BLA 761145). Payer policies: UnitedHealthcare, Aetna, Cigna, Anthem/Carelon, regional BCBS (combined Darzalex + Darzalex Faspro policies).
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. We do not paraphrase from billing-software vendor blogs. When manufacturer guidance and payer policy conflict (as happens with the 96401 vs. 96372 administration code question and site-of-care preferences), we surface the conflict rather than picking a side.