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.
| Brand (generic) | HCPCS | Manufacturer | Dose / visit | Total course | Unit basis | ASP+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) |
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 item | Monoferric (J1437) | Injectafer (J1439) |
|---|---|---|
| Course total | 1,000 mg (single dose) | 1,500 mg (750 mg × 2) |
| Visits per course | 1 | 2 (separated by ≥7 days) |
| Admin claims per course | 1 | 2 |
| Drug-line claims per course | 1 | 2 |
| No-show risk on second visit | None | Present (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) |
Dosing & unit math FDA label most recent rev
From the current FDA prescribing information (NDA 208171, originally approved January 2020).
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
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
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) | Package | Use |
|---|---|---|
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 |
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.
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.
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.
Administration codes CPT verified May 2026
Monoferric is non-chemotherapy — therapeutic IV codes apply, not chemo admin codes.
| Code | Description | When 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. |
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.
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
| Code | Description |
|---|---|
D50.0 | Iron deficiency anemia secondary to chronic blood loss (e.g., GI, GU, menorrhagia) |
D50.8 | Other iron deficiency anemias |
D50.9 | Iron deficiency anemia, unspecified |
D62 | Acute posthemorrhagic anemia |
D64.9 | Anemia, unspecified (rarely sufficient on its own; pair with workup documentation) |
CKD anemia (non-dialysis-dependent)
| Code | Description |
|---|---|
N18.1–N18.5 | CKD stages 1–5 (NDD) |
N18.30–N18.32 | CKD stage 3 (3a / 3b / unspecified) |
N18.4 | CKD stage 4 |
N18.5 | CKD stage 5 (non-dialysis-dependent) |
D63.1 | Anemia in chronic kidney disease (pair with N18.x) |
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.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Physician office (heme, GI, OB-GYN, nephrology) | 11 | CMS-1500 / 837P | Preferred by commercial UM |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Preferred by commercial UM |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Disfavored on commercial plans |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored on commercial plans |
| Patient home | 12 | CMS-1500 (with home infusion) | Possible via specialty home infusion vendors; rare |
Claim form field mapping Pharmacosmos 2025 billing guide
From Pharmacosmos / Monoferric HCP coding & coverage materials.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 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 units | 24G | 100 (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-10 | 21 | Indication-specific (D50.x for IDA; N18.x + D63.1 for CKD) |
| PA number | 23 | Required by all major commercial payers |
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.
| Payer | PA? | Lab thresholds | Step / 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
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
Common denials & how to fix them
| Denial / takeback reason | Common cause | Fix |
|---|---|---|
| Unit basis error (10× overbilling) | Billed 1,000 units for 1,000 mg dose, treating J1437 as 1 mg per unit | Resubmit corrected with 100 units. Audit all J1437 lines for divide-by-10. Most common Monoferric error. |
| Oral iron failure not documented | PA submitted without oral iron trial history | Submit chart documentation of oral iron type, dose, duration, and reason for failure (intolerance, lack of response, ongoing GI losses). |
| Lab thresholds not met | Ferritin / TSAT / Hgb above payer threshold | Submit 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 IV | Resubmit with 96365 (or 96374 for sub-500 mg push). Monoferric is non-chemotherapy. |
| JZ missing on full-vial claim | Single-dose vial claim without JZ | Resubmit with JZ. Required since 7/1/2023 on every claim with no waste. |
| JW units error | Reported waste in mg instead of 10 mg units | Divide waste mg by 10 for J1437 JW units. 300 mg waste = 30 JW units, not 300. |
| HF indication denial | Billed Monoferric for HF iron deficiency | Switch to Injectafer (J1439) — only IV iron with FDA HF approval (2023). Monoferric off-label in HF generally non-covered. |
| Step therapy — Injectafer first | Plan requires Injectafer trial before Monoferric | Submit 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 UM | Move to office (POS 11) or AIC (POS 49). Submit medical necessity letter if HOPD required. |
| Wrong indication (ESRD/dialysis) | J1437 billed for hemodialysis patient | Switch to ESRD-bundled IV iron (Venofer/Feraheme) per CMS policy. Monoferric is non-dialysis-dependent CKD only. |
| Pediatric denial | J1437 billed for patient <18 years | Monoferric 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.
Source documents
- DailyMed — MONOFERRIC (ferric derisomaltose) Prescribing Information
- Monoferric HCP / patient site (Pharmacosmos Therapeutics)
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — HCPCS J1437 reference
- UnitedHealthcare — IV Iron Therapy / Medical Drug Policies
- Aetna CPB — Parenteral Iron Therapy
- FDA National Drug Code Directory
- KDIGO — Anemia in CKD Guideline
- ACG — Iron Deficiency Anemia Clinical Guideline
- 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
| 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) + hypophosphatemia-risk override rules | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules | Annual | Reviewed against CMS HCPCS quarterly files and AMA CPT releases. |
| NDC, dosing, FDA label, indication list, single-dose advantage callout | Event-driven | Tied to manufacturer document version + FDA label revision date. |
| IV iron class comparison (per-mg / per-unit ASP across products) | Annual | Re-priced from CMS Q2 file each year; descriptive comparison reviewed annually. |
Reviewer
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.