Monoferric (ferric derisomaltose) — HCPCS J1437

Pharmacosmos Therapeutics · 100 mg/1 mL, 500 mg/5 mL, 1,000 mg/10 mL single-dose vials · IV infusion (~20–60 min) or slow IV push (≤500 mg) · IDA / non-dialysis CKD

Monoferric is the only IV iron product approved for delivery of a complete IDA course in a single visit. Billed under HCPCS J1437 at 10 mg per unit — an unusual unit basis that is a frequent biller error trap (Injectafer's J1439 is 1 mg per unit). Standard regimen: 1,000 mg single-dose IV (one visit) for adults ≥50 kg with Hgb 8–13.5 g/dL. Q2 2026 Medicare reimbursement: $21.930/10 mg unit ($2,193.00 per 1,000 mg course, ASP + 6%). FERWON trials show lower hypophosphatemia rates than Injectafer.

ASP data:Q2 2026 (live)
Payer policies:verified May 2026
Manufacturer guide:Pharmacosmos 2025
FDA label:most recent revision
Page reviewed:

Instant Answer — the 5 things you need to bill J1437

HCPCS
J1437
10 mg = 1 unit (NOT 1 mg)
Standard course
100 units
1,000 mg single-dose · 1 visit
Modifier
JZ
Required (single-dose vial, no waste)
Admin CPT
96365
Therapeutic IV (~30–60 min)
Medicare ASP+6%
$21.930
per 10 mg unit, Q2 2026 · $2,193.00/1,000 mg
HCPCS descriptor
J1437 — "Injection, ferric derisomaltose, 10 mg" Permanent
Adult dosing
1,000 mg single-dose IV for body weight ≥50 kg with Hgb 8–13.5 g/dL; full course in one visit. Lower doses calculated by the Ganzoni formula for patients <50 kg or specific Hgb ranges.
Pediatric dosing
Not FDA-approved for pediatric IDA. Use Venofer (iron sucrose) or off-label ferumoxytol per pediatric heme/nephrology protocols.
Indications
Iron-deficiency anemia (IDA) in adults intolerant or unresponsive to oral iron, OR with non-hemodialysis-dependent chronic kidney disease (NDD-CKD)
NDC
71909-410-10 — 1,000 mg / 10 mL single-dose vial (also 71909-405-05 500 mg/5 mL and 71909-401-01 100 mg/1 mL); verify exact NDC against current Pharmacosmos product carton
Vials
100 mg/mL solution — 100 mg/1 mL, 500 mg/5 mL, 1,000 mg/10 mL single-dose vials
Route
IV infusion: >20 minutes for doses ≤500 mg, ≥30 minutes for doses 500–1,000 mg; slow IV push permitted for doses ≤500 mg
Premedication
Not routinely required — observe for hypersensitivity
Boxed warning
None. W&P: serious hypersensitivity reactions (including anaphylactic-type reactions) and hypertension. Lower hypophosphatemia rate than Injectafer per FERWON-IDA / FERWON-NEPHRO published data.
FDA approval
January 2020 (NDA 208171); only IV iron approved for delivery of a 1,000 mg complete course in a single visit
⚠️
BILLER ERROR TRAP — J1437 = 10 mg per unit, NOT 1 mg. Almost every other IV iron HCPCS uses a 1 mg unit basis (Injectafer J1439, Venofer J1756, INFeD J1750). Monoferric's J1437 descriptor reads "Injection, ferric derisomaltose, 10 mg" — one billable unit equals ten milligrams of elemental iron. The standard 1,000 mg single-dose course is billed as 100 units, not 1,000 units. Billing 1,000 units triggers either a duplicate-billing denial or a 10× overpayment that triggers MAC takeback. Verify the unit basis on every J1437 claim. See unit math →
Single-dose advantage — one visit, full course. Monoferric is the only IV iron approved for delivery of a complete 1,000 mg IDA course in a single visit. Compare to Injectafer (J1439): two 750 mg doses separated by ≥7 days = two infusion-suite visits, two admin claims, and second-dose no-show risk. Some UnitedHealthcare plans now prefer Monoferric over Injectafer specifically for cost-per-completed-course in benefit design. See single-dose detail →
ℹ️
Lower hypophosphatemia rate vs Injectafer. The FERWON-IDA and FERWON-NEPHRO randomized trials showed Monoferric (ferric derisomaltose) had significantly lower rates of incident hypophosphatemia compared to Injectafer (ferric carboxymaltose). For patients with prior hypophosphatemia, malnutrition, hyperparathyroidism, or vitamin D deficiency — or for repeat-course patients — this is a clinically and operationally important differentiator. Several payers post-2024 allow direct access to Monoferric without Injectafer step therapy specifically when these risk factors are documented. See hypophosphatemia comparison →
Phase 1 Identify what you're billing Confirm the right code, the 10 mg unit basis, single-dose course, and indication-specific PA criteria.

IV iron class — how Monoferric compares CMS ASP Q2 2026

Five major IV iron products. Monoferric is the only product approved for delivery of a complete IDA course in a single visit, and uses an unusual 10 mg unit basis on its HCPCS.

Comparison of major IV iron products: HCPCS code, manufacturer, dose-per-visit, total course, unit basis, and Q2 2026 ASP+6%.
Brand (generic)HCPCSManufacturerDose / visitTotal courseUnit basisASP+6%
Monoferric (ferric derisomaltose) J1437 Pharmacosmos 1,000 mg in ~30–60 min 1,000 mg (single dose) 10 mg = 1 unit $21.930 / 10 mg ($2.193/mg)
Injectafer (ferric carboxymaltose) J1439 American Regent / CSL Vifor 750 mg in ~15 min 1,500 mg (2 doses, ≥7 days apart) 1 mg = 1 unit $1.103 / mg
Feraheme (ferumoxytol) Q0138 (non-ESRD) AMAG / Covis 510 mg in ~15 min 1,020 mg (2 doses, 3–8 days apart) 1 mg = 1 unit ~$0.229 / mg (verify CMS file)
Venofer (iron sucrose) J1756 American Regent 200–300 mg per visit 1,000 mg total over 5+ visits 1 mg = 1 unit ~$0.223 / mg (verify CMS file)
INFeD (iron dextran) J1750 Allergan / AbbVie Up to total dose infusion (TDI) per protocol Calculated; requires test dose 50 mg = 1 unit ~$13 / 50 mg unit (verify CMS file)
Two unit-basis traps in this table. Monoferric J1437 (10 mg/unit) and INFeD J1750 (50 mg/unit) do NOT use the 1-mg-per-unit pattern of J1439 / Q0138 / J1756. Multiplying mg by 1 to derive units will produce 10× overbilling on Monoferric and 50× overbilling on INFeD. The 1,000 mg Monoferric course is always 100 units of J1437.
Why Monoferric exists in the modern formulary: single-dose-per-course delivery in one visit, plus lower hypophosphatemia rate than Injectafer in head-to-head FERWON trials. Trade-off: per-mg ASP is roughly twice Injectafer's per-mg ASP, but the chair-time and admin-cost saving across one visit instead of two often offsets the per-mg premium for full-course economics.

Single-dose advantage FDA label + payer policy review

Monoferric is the only US IV iron product that delivers a complete 1,000 mg IDA course in a single infusion visit.

Workflow itemMonoferric (J1437)Injectafer (J1439)
Course total1,000 mg (single dose)1,500 mg (750 mg × 2)
Visits per course12 (separated by ≥7 days)
Admin claims per course12
Drug-line claims per course12
No-show risk on second visitNonePresent (course incomplete on no-show)
Chair time per course (typical)~45–60 min~30 min total (15 min × 2)
Total drug ASP+6% (Q2 2026)~$2,193 (1,000 mg)~$1,654.50 (1,500 mg)
Cost-per-completed-course preference. Some UnitedHealthcare commercial plans now prefer Monoferric over Injectafer in their IV iron policy — the rationale is that Injectafer second-dose no-shows leave the course incomplete (under-treated patients re-cycle to another course later), inflating completed-course cost. Monoferric's one-visit course closes that risk.
Operational caveat — chair time per visit is longer. A 1,000 mg Monoferric infusion runs ~30–60 minutes, vs. 15 minutes per Injectafer visit. If your infusion suite optimizes for chair-flips-per-day rather than completed-courses-per-month, the trade-off may not favor Monoferric. Look at suite utilization, not just claim counts, before standardizing on a single product.

Dosing & unit math FDA label most recent rev

From the current FDA prescribing information (NDA 208171, originally approved January 2020).

Unit basis: 10 mg = 1 unit (J1437). Almost every other IV iron HCPCS uses a 1 mg per unit basis. Always divide mg administered by 10 to derive J1437 units. The standard 1,000 mg single-dose course = 100 units, not 1,000 units.

Adults ≥50 kg, Hgb 8–13.5 g/dL

  • 1,000 mg single-dose IV — full course delivered in one visit
  • IV infusion over ≥30 minutes (per FDA label for doses 500–1,000 mg)
  • 1 unit = 10 mg — bill 100 units of J1437
  • Course may be repeated if iron deficiency recurs

Adults <50 kg or specific Hgb ranges

  • Cumulative dose calculated by the Ganzoni formula:
    Iron deficit (mg) = body weight (kg) × (target Hgb − actual Hgb) (g/dL) × 2.4 + iron stores (mg)
  • Round to the nearest 100 mg vial increment
  • Doses ≤500 mg may be given as IV infusion >20 min OR slow IV push
  • Doses 500–1,000 mg given as IV infusion ≥30 min
  • Bill the actual mg administered divided by 10 (e.g., 700 mg = 70 units)

Worked example — standard adult IDA, 1,000 mg single-dose course

# Course = single 1,000 mg IV dose, one visit
Drug units billed: 100 (J1437, 10 mg per unit)
HCPCS: J1437 · Modifier: JZ · Vials: 1 × 1,000 mg/10 mL
Admin: 96365 (~30–60 min infusion)

# Course totals
Total visits: 1
Total drug units billed: 100
Total drug cost (Q2 2026 ASP+6%): ~$2,193.00 before sequestration
Equivalent per-mg: ~$2.193 (~2× Injectafer's per-mg ASP, but full course in one visit)

Worked example — weight-based, 700 mg dose

# Patient: 45 kg, target Hgb 12, actual Hgb 9, iron stores 500 mg
Iron deficit = 45 × (12 − 9) × 2.4 + 500 = 824 mg → round to 800 mg or 700 mg vial fill

Vial used: 1 × 1,000 mg vial (300 mg waste if 700 mg given) OR
Vial used: 1 × 500 mg + 1 × 100 mg + 1 × 100 mg (700 mg, no waste from 1,000 mg vial)

# Optimize NDC selection to minimize JW waste
Drug units billed (administered): 70 (J1437)
Drug units billed (waste, if any): variable (JW modifier)

Premedication

Not routinely required. Observe patient for hypersensitivity reactions during and for at least 30 minutes after administration. Personnel and therapies for managing anaphylactic reactions must be immediately available.

NDC reference FDA NDC Directory verified May 2026

NDC (10/11-digit)PackageUse
71909-410-10 / 71909-0410-10 1,000 mg / 10 mL single-dose vial — 1 vial per carton Standard 1,000 mg single-dose course; one vial per visit for adults ≥50 kg with Hgb 8–13.5
71909-405-05 / 71909-0405-05 500 mg / 5 mL single-dose vial Weight-based / Ganzoni-calculated doses where 500 mg fits the increment; reduces JW waste
71909-401-01 / 71909-0401-01 100 mg / 1 mL single-dose vial Used in combination with 500 mg vial to build precise weight-based doses without partial-vial waste
Use the carton-level NDC on the claim. Pharmacosmos labeler code is 71909. Confirm the 11-digit format your payer expects (some require the 5-4-2 padded form, e.g., 71909-0410-10). Use N4 qualifier in box 24A shaded area on CMS-1500. Verify each NDC against the actual carton received before billing — SKU-level NDCs may rotate.
Vial-pick optimization for waste minimization: for weight-based doses, building from the 100 mg + 500 mg SKUs is often cheaper than pulling from a 1,000 mg vial and discarding. Example: 600 mg dose = 1 × 500 mg + 1 × 100 mg (zero waste) versus 1 × 1,000 mg vial with 400 mg JW waste. CMS reimburses wasted drug, but suite formulary policy may prefer the no-waste configuration.

Hypophosphatemia — lower rate vs Injectafer FERWON trial program

Head-to-head FERWON-IDA and FERWON-NEPHRO trials demonstrated significantly lower hypophosphatemia rates with Monoferric vs Injectafer.

The FERWON-IDA (general IDA) and FERWON-NEPHRO (NDD-CKD) randomized trials directly compared ferric derisomaltose (Monoferric) to ferric carboxymaltose (Injectafer). Across both studies, incident hypophosphatemia was substantially less frequent and less severe with Monoferric. After the FDA strengthened Injectafer's hypophosphatemia W&P in 2024, this differential became more clinically and operationally important.

Monoferric is the preferred IV iron in patients at hypophosphatemia risk: documented prior hypophosphatemia, malnutrition, hyperparathyroidism, vitamin D deficiency, concurrent oral phosphate-binding therapy, or chronic recurrent IV iron need. Several payers post-2024 allow direct access to Monoferric without Injectafer step therapy when these risk factors are documented in the chart.

Payer impact

  • UnitedHealthcare — some plans now accept Monoferric without Injectafer step therapy when documented prior hypophosphatemia or risk factors are submitted on the PA.
  • Several BCBS plans — medical policy updates 2024–2025 added Monoferric as a preferred alternative for hypophosphatemia-risk patients.
  • Medicare MACs — no NCD/LCD changes specific to product preference; choice driven by indication and chair-time economics.
Documentation tip: for patients with prior IV iron exposure, capture the most recent serum phosphate result and any prior hypophosphatemia event in the chart. Reference both in the PA submission to unlock direct-access Monoferric and bypass Injectafer step therapy.
Phase 2 Code the claim Therapeutic IV admin (96365) for typical 1,000 mg infusions; 96374 for sub-500 mg push. Don't bill chemo admin codes.

Administration codes CPT verified May 2026

Monoferric is non-chemotherapy — therapeutic IV codes apply, not chemo admin codes.

CodeDescriptionWhen to use
96365 Therapeutic, prophylactic, or diagnostic IV infusion, up to 1 hour, single or initial substance/drug Primary code for Monoferric. The standard 1,000 mg single-dose infusion runs ~30–60 minutes per FDA label, fitting within the 1-hour 96365 window.
96366 Each additional hour of therapeutic IV infusion Rarely needed for the typical 30–60 min Monoferric infusion. Consider only if the infusion is genuinely extended beyond 60 minutes for clinical reasons.
96374 Therapeutic IV push, single or initial drug Use when site administers Monoferric ≤500 mg as slow IV push (per FDA label allowance). Verify with payer — some payers prefer 96365 even for shortened infusions.
96413 Chemotherapy administration, IV infusion NOT appropriate. Monoferric is non-chemotherapy; do not use chemo admin codes.
Push vs infusion: the FDA label allows slow IV push for doses ≤500 mg. The 1,000 mg single-dose adult course must be administered as IV infusion over ≥30 min. Choose your billing pattern (96365 for 1,000 mg infusion; 96374 for sub-500 mg push) consistently per site and confirm with each major payer.

Modifiers CMS verified May 2026

JZ — required on virtually every full-vial claim

Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. The standard Monoferric 1,000 mg adult dose uses one full 1,000 mg / 10 mL single-dose vial with zero waste, so JZ applies on virtually every adult full-vial claim. For weight-based doses delivered from a vial-stack that produces no leftover (e.g., 600 mg = 500 mg + 100 mg with no remainder), JZ also applies.

JW — weight-based dosing with partial-vial waste

JW reports the discarded portion of a single-dose vial. For Monoferric, JW applies when weight-based dosing produces partial-vial waste. Example: a 700 mg dose drawn from a 1,000 mg vial discards 300 mg — bill JW with 30 units of waste (300 mg ÷ 10 mg per unit = 30 units) on a separate claim line. One of JZ or JW must be on every J1437 claim.

Common error #1 — unit basis on the JW line. The JW line uses the same J1437 unit basis (10 mg per unit). 300 mg of waste = 30 units of JW, not 300. Auditors catch this on takebacks.
Common error #2 — failing to bill waste at all. CMS reimburses wasted single-dose-vial drug when documented with JW. On weight-based or Ganzoni-calculated doses, always evaluate vial selection first (use 100 mg + 500 mg + 1,000 mg combinations to minimize waste), then bill JW for any remainder.

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 Monoferric, follow your MAC's current 340B modifier policy. Pharmacosmos's billing guide does not provide 340B-specific instructions; defer to MAC and 340B program guidance.

ICD-10-CM by indication FY2026 verified May 2026

Two indication families: IDA (general) and CKD anemia (non-dialysis-dependent). Monoferric is NOT approved for HF iron deficiency or pediatric IDA — refer to Injectafer for those indications.

IDA — iron deficiency anemia

CodeDescription
D50.0Iron deficiency anemia secondary to chronic blood loss (e.g., GI, GU, menorrhagia)
D50.8Other iron deficiency anemias
D50.9Iron deficiency anemia, unspecified
D62Acute posthemorrhagic anemia
D64.9Anemia, unspecified (rarely sufficient on its own; pair with workup documentation)

CKD anemia (non-dialysis-dependent)

CodeDescription
N18.1–N18.5CKD stages 1–5 (NDD)
N18.30–N18.32CKD stage 3 (3a / 3b / unspecified)
N18.4CKD stage 4
N18.5CKD stage 5 (non-dialysis-dependent)
D63.1Anemia in chronic kidney disease (pair with N18.x)
N18.6 (ESRD) and dialysis-dependent CKD are NOT Monoferric indications. The FDA label specifies non-hemodialysis-dependent CKD. Dialysis patients should be billed under ESRD bundled payment and use Venofer or Feraheme per CMS ESRD policy.
HF iron deficiency: Monoferric is NOT FDA-approved for HF iron deficiency in the US. For HFrEF + iron deficiency, Injectafer (J1439) holds the 2023 FDA HF approval. Off-label Monoferric in HF is generally non-covered without product-specific medical necessity documentation.
Multi-indication coding: a patient may have CKD + IDA. Code both family heads (N18.x + D63.1 alongside D50.x) when the documentation supports both. Most major payers will approve under whichever indication has the cleanest documentation.

Site of care & place of service Verified May 2026

UnitedHealthcare, Aetna, and most major BCBS plans run site-of-care UM for IV iron. Office and ambulatory infusion suite are preferred; hospital outpatient is generally disfavored after the first course. Monoferric's single-visit advantage favors AIC and physician office sites with predictable chair-time slots.

SettingPOSClaim formPayer steering
Physician office (heme, GI, OB-GYN, nephrology)11CMS-1500 / 837PPreferred by commercial UM
Ambulatory infusion suite (AIC)49CMS-1500 / 837PPreferred by commercial UM
Hospital outpatient (on-campus)22UB-04 / 837IDisfavored on commercial plans
Hospital outpatient (off-campus PBD)19UB-04 / 837IDisfavored on commercial plans
Patient home12CMS-1500 (with home infusion)Possible via specialty home infusion vendors; rare
Single-visit chair planning: the 1,000 mg Monoferric infusion at ~30–60 minutes fits cleanly into AIC chair-time slots without requiring a second appointment. Practices that struggle with second-visit no-show losses on Injectafer often see operational gains by switching IDA patients to Monoferric.

Claim form field mapping Pharmacosmos 2025 billing guide

From Pharmacosmos / Monoferric HCP coding & coverage materials.

InformationCMS-1500 boxNotes
NPI17bRendering provider
NDC qualifier + 11-digit NDC + UoM + qty24A shaded areaN4 + 71909-0410-10 + ML + 10 (mL) for 1,000 mg dose
HCPCS J1437 + JZ (or JW for waste)24D (drug line)JZ on virtually every adult full-vial claim
Drug units24G100 (1,000 mg single-dose course) — 10 mg per unit, NOT 1,000 units
CPT 96365 (admin line)24D (admin line)Or 96374 if administered as IV push for a sub-500 mg dose
ICD-1021Indication-specific (D50.x for IDA; N18.x + D63.1 for CKD)
PA number23Required by all major commercial payers
Pre-submission unit-basis check: before claim release, audit every J1437 line for the 10 mg unit basis. The most common audit-back is "billed 1,000 units for 1,000 mg dose" — fix to 100 units.
Phase 3 Get paid PA criteria are formula-driven: ferritin / TSAT thresholds, oral iron failure, indication-specific specialist.

Payer policy snapshot Reviewed May 2026

Major payers gate Monoferric on labs (ferritin/TSAT), oral iron history, and indication-specific specialist consult. Some plans now prefer Monoferric over Injectafer for cost-per-completed-course or hypophosphatemia-risk patients.

PayerPA?Lab thresholdsStep / Preference
UnitedHealthcare
IV Iron Therapy medical drug policy
Yes Ferritin <100 ng/mL OR TSAT <20%; Hgb threshold per indication Some commercial plans prefer Monoferric over Injectafer for cost-per-completed-course; documented oral iron failure required
Aetna
CPB Parenteral Iron Replacement
Yes Ferritin <100 OR TSAT <20%; aligned with KDIGO IDA / ACG guidelines Monoferric and Injectafer at parity in most plans; specialist preferred but not strict
BCBS plans
Vary by plan
Yes Generally aligned with KDIGO IDA / CKD anemia guidelines Plan-specific; some plans direct Monoferric for hypophosphatemia-risk patients without Injectafer step therapy
Medicare (MAC LCDs)
No NCD; MAC discretion
No (PA not required, but documentation expected) Indication-appropriate workup in chart None — choice driven by indication and chair-time economics

Step therapy

Most commercial payers require documented oral iron failure or intolerance before approving any IV iron product (Monoferric, Injectafer, Feraheme, Venofer). Some plans also impose intra-class step therapy — either preferring Venofer (lowest per-mg cost) before Monoferric, or preferring Monoferric for completed-course economics. Verify the payer's IV iron formulary tier before prescribing.

Hypophosphatemia-risk override

Several payers post-2024 allow direct access to Monoferric without Injectafer step therapy when the chart documents prior hypophosphatemia, malnutrition, hyperparathyroidism, vitamin D deficiency, or chronic recurrent IV iron need. Submit prior phosphate values and clinical context with the PA to unlock direct-access Monoferric.

Medicare reimbursement CMS Q2 2026 (live)

Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.

Q2 2026 payment snapshot — J1437

Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions · Unit basis: 10 mg = 1 unit

ASP + 6%
$21.930
per 10 mg unit (~$2.193/mg)
1,000 mg dose
$2,193.00
100 units × ASP+6%
Single-dose course
$2,193.00
1 visit per course
Annualized cost (one course/year typical): 1,000 mg per course at Q2 2026 ASP+6% = ~$2,193/year per patient on a single course. Patients with recurrent iron deficiency may receive 2 courses/year (~$4,386). After ~2% sequestration: ~$2,149/course actual paid. Per-mg ASP is roughly 2× Injectafer's per-mg ASP, but the total course is delivered in one visit (vs Injectafer's two), eliminating second-visit admin claims and no-show risk.

Coverage

No NCD specific to ferric derisomaltose. Coverage falls under MAC LCDs for IV iron therapy and the generic drug-coverage framework. All MACs cover J1437 for FDA-approved on-label indications (IDA + NDD-CKD) with appropriate ICD-10 documentation.

Code history

  • J1437 — permanent code; descriptor "Injection, ferric derisomaltose, 10 mg" (1 unit = 10 mg elemental iron)
  • Active long enough that all major commercial payers maintain Monoferric-specific medical drug policies and parity / step decisions vs Injectafer

Patient assistance — Pharmacosmos Patient Support Pharmacosmos verified May 2026

  • Pharmacosmos Patient Support / Monoferric Co-pay Assistance: 1-833-666-3373 — benefits investigation, prior authorization assistance, appeal support
  • Commercial copay assistance: first dose may be $0 for eligible commercially-insured patients via the Monoferric Co-pay Program
  • Pharmacosmos Patient Assistance Foundation / PAP: free product for uninsured / underinsured patients meeting income requirements
  • Foundations: for Medicare patients with IDA secondary to GI bleed or chronic disease, refer to PAN, HealthWell, NeedyMeds — verify open IDA / CKD funds quarterly
  • Web: monoferric.com
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance, and OOP max? Run a CareCost Estimate — J1437 pre-loaded with the 10 mg unit basis correctly configured.
Phase 4 Fix problems Top denials: wrong unit basis (1,000 vs 100 units), missing oral iron failure documentation, wrong admin code.

Common denials & how to fix them

Denial / takeback reasonCommon causeFix
Unit basis error (10× overbilling)Billed 1,000 units for 1,000 mg dose, treating J1437 as 1 mg per unitResubmit corrected with 100 units. Audit all J1437 lines for divide-by-10. Most common Monoferric error.
Oral iron failure not documentedPA submitted without oral iron trial historySubmit chart documentation of oral iron type, dose, duration, and reason for failure (intolerance, lack of response, ongoing GI losses).
Lab thresholds not metFerritin / TSAT / Hgb above payer thresholdSubmit current labs with PA. If borderline, supplement with documentation of clinical iron deficiency context (CKD, GI bleed, menorrhagia).
Wrong admin code (96413)Chemo IV billed instead of therapeutic IVResubmit with 96365 (or 96374 for sub-500 mg push). Monoferric is non-chemotherapy.
JZ missing on full-vial claimSingle-dose vial claim without JZResubmit with JZ. Required since 7/1/2023 on every claim with no waste.
JW units errorReported waste in mg instead of 10 mg unitsDivide waste mg by 10 for J1437 JW units. 300 mg waste = 30 JW units, not 300.
HF indication denialBilled Monoferric for HF iron deficiencySwitch to Injectafer (J1439) — only IV iron with FDA HF approval (2023). Monoferric off-label in HF generally non-covered.
Step therapy — Injectafer firstPlan requires Injectafer trial before MonoferricSubmit hypophosphatemia-risk documentation (prior hypoP, malnutrition, hyperparathyroidism, vit-D deficiency) for direct-access Monoferric, or submit Injectafer failure / intolerance.
Site-of-care (HOPD)HOPD administration on commercial plan with site-of-care UMMove to office (POS 11) or AIC (POS 49). Submit medical necessity letter if HOPD required.
Wrong indication (ESRD/dialysis)J1437 billed for hemodialysis patientSwitch to ESRD-bundled IV iron (Venofer/Feraheme) per CMS policy. Monoferric is non-dialysis-dependent CKD only.
Pediatric denialJ1437 billed for patient <18 yearsMonoferric is NOT FDA-approved for pediatric IDA. Switch to Venofer or pediatric-specific IV iron protocol.

Frequently asked questions

What is the HCPCS code for Monoferric?

Monoferric (ferric derisomaltose IV) is billed under HCPCS J1437 — "Injection, ferric derisomaltose, 10 mg." One billable unit equals 10 mg of elemental iron — NOT 1 mg. This 10 mg unit basis is unusual in IV iron and is a frequent biller error trap because the competing product Injectafer (J1439) uses a 1 mg unit basis. The standard 1,000 mg single-dose course is billed as 100 units of J1437.

How many units do I bill for a Monoferric dose?

Bill 100 units of J1437 for the standard 1,000 mg single-dose course in adults ≥50 kg with Hgb 8–13.5 g/dL. For lower-dose regimens calculated by the Ganzoni formula (patients <50 kg or specific Hgb ranges), bill actual mg administered ÷ 10. Example: a 700 mg dose = 70 units billed. Common error: billing 1,000 units instead of 100 units after confusing the J1437 unit basis with Injectafer's 1 mg unit.

What administration CPT do I use for Monoferric?

CPT 96365 — "Therapeutic, prophylactic, or diagnostic IV infusion, up to 1 hour" is the most common admin code for Monoferric. The FDA label specifies infusion over >20 minutes for doses ≤500 mg, and ≥30 minutes for doses 500–1,000 mg, so a typical 1,000 mg single-dose infusion runs ~30–60 minutes — fitting within the 1-hour 96365 window. Sites administering doses ≤500 mg as slow IV push may bill 96374 ("IV push, single drug"); verify with payer policy. Do NOT bill 96413 (chemotherapy admin) — Monoferric is non-chemotherapy.

What is the major billing advantage of Monoferric over Injectafer?

Monoferric delivers a complete IV iron course in a single visit (one 1,000 mg dose), versus Injectafer's two 750 mg doses separated by ≥7 days (two visits). This single-dose advantage translates to one administration claim instead of two, fewer chair-time hours, fewer no-show risks on the second visit, and lower total admin cost per completed course. Some UnitedHealthcare plans now prefer Monoferric over Injectafer specifically for cost-per-completed-course in benefit design.

Do I bill JZ or JW for Monoferric?

Bill JZ on virtually every full-vial Monoferric claim. Monoferric ships in single-dose vials (100 mg/1 mL, 500 mg/5 mL, and 1,000 mg/10 mL); the standard 1,000 mg adult dose uses one full 1,000 mg vial with zero waste. JW is needed when weight-based dosing produces partial-vial waste — bill JW with the discarded units (mg waste ÷ 10) on a separate line. One of JZ or JW must be on every J1437 claim per CMS's July 2023 single-dose container policy.

What is the Medicare reimbursement for J1437?

For Q2 2026, the Medicare Part B payment limit for J1437 is $21.930 per 10 mg unit (ASP + 6%) — equivalent to about $2.193 per mg. The standard 1,000 mg single-dose course reimburses at approximately $2,193.00 in drug cost (100 units × ASP+6%), delivered in one infusion visit. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.

What indications does Monoferric cover?

Monoferric is FDA-approved for iron-deficiency anemia (IDA) in adults who have intolerance to oral iron or have had unsatisfactory response to oral iron, OR who have non-hemodialysis-dependent chronic kidney disease (NDD-CKD). The label does NOT cover dialysis-dependent CKD or pediatric IDA — patients on hemodialysis should be billed under ESRD-bundled IV iron policy using Venofer or Feraheme, and pediatric IDA should use Venofer or Injectafer (Injectafer was approved for pediatric IDA in 2024).

How does Monoferric compare to other IV irons on hypophosphatemia?

The FERWON-IDA and FERWON-NEPHRO trials showed Monoferric (ferric derisomaltose) had significantly lower rates of incident hypophosphatemia compared to Injectafer (ferric carboxymaltose) — a clinical advantage in patients at hypophosphatemia risk (chronic recurrent IV iron need, malnutrition, hyperparathyroidism, vitamin D deficiency). Several payers post-2024 now allow direct access to Monoferric without Injectafer step therapy specifically for patients with documented prior hypophosphatemia or risk factors.

How does Monoferric compare to other IV irons?

Monoferric (J1437, ferric derisomaltose, 1,000 mg single-dose, ~$21.93 per 10 mg unit) competes with Injectafer (J1439, ferric carboxymaltose, 750 mg × 2 doses, ~$1.103 per mg), Feraheme (Q0138, ferumoxytol, 510 mg × 2 doses), Venofer (J1756, iron sucrose, 200–300 mg multiple doses), and INFeD (J1750, iron dextran, requires test dose). Monoferric is the only IV iron product approved for delivery of a complete IDA course in a single visit, which is its primary differentiator.

Reference Sources & methodology Every claim on this page is sourced. Methodology and review history below.

Source documents

  1. DailyMed — MONOFERRIC (ferric derisomaltose) Prescribing Information
    FDA-approved label; most recent revision (NDA 208171, originally approved January 2020)
  2. Monoferric HCP / patient site (Pharmacosmos Therapeutics)
    Manufacturer coding & coverage materials; patient support: 1-833-666-3373
  3. CMS — Medicare Part B Drug ASP Pricing File
    Q2 2026 quarterly file, effective April 1 – June 30, 2026
  4. SEER CanMED — HCPCS J1437 reference
    "Injection, ferric derisomaltose, 10 mg" — canonical 10 mg unit basis
  5. UnitedHealthcare — IV Iron Therapy / Medical Drug Policies
  6. Aetna CPB — Parenteral Iron Therapy
  7. FDA National Drug Code Directory
  8. KDIGO — Anemia in CKD Guideline
  9. ACG — Iron Deficiency Anemia Clinical Guideline
  10. FERWON-IDA and FERWON-NEPHRO — head-to-head ferric derisomaltose vs ferric carboxymaltose trial publications (hypophosphatemia, hypersensitivity, efficacy endpoints)

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

ElementCadenceHow it's refreshed
Medicare ASP pricingQuarterlyAuto-bound to CareCost ASP layer; updates on CMS file release.
Payer policies (UHC, Aetna, BCBS) + hypophosphatemia-risk override rulesSemi-annualManual review against published payer policy documents.
HCPCS / CPT / modifier rulesAnnualReviewed against CMS HCPCS quarterly files and AMA CPT releases.
NDC, dosing, FDA label, indication list, single-dose advantage calloutEvent-drivenTied to manufacturer document version + FDA label revision date.
IV iron class comparison (per-mg / per-unit ASP across products)AnnualRe-priced from CMS Q2 file each year; descriptive comparison reviewed annually.

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 — especially the J1437 unit basis (10 mg = 1 unit) and any NDC values.

Change log

  • — Initial publication. ASP data: Q2 2026 ($21.930 per 10 mg unit). Manufacturer source: Pharmacosmos 2025 materials. FDA label: most recent revision (NDA 208171). Single-dose advantage and FERWON hypophosphatemia comparison emphasized. IV iron class comparison covers Monoferric / Injectafer / Feraheme / Venofer / INFeD with explicit unit-basis column.

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 is verified against the current FDA label revision. We do not paraphrase from billing-software vendor blogs.

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