Q0138 (non-ESRD) vs Q0139 (ESRD) — biller decision CMS verified May 2026
Same drug, two HCPCS codes. The choice is driven by the patient's ESRD/dialysis status, not the dose or setting.
Ferumoxytol is unique among IV irons in having two parallel permanent HCPCS codes that distinguish
indication: Q0138 for non-ESRD iron-deficiency anemia and Q0139 for ESRD
patients on dialysis. The drug, dose (510 mg), NDC, and administration are identical — only the
billing code differs.
| Q0138 (non-ESRD) | Q0139 (ESRD) | |
|---|---|---|
| HCPCS descriptor | Q0138 — "Ferumoxytol, non-ESRD use, 1 mg" | Q0139 — "Ferumoxytol, ESRD on dialysis, 1 mg" |
| Patient population | Adults with iron-deficiency anemia (IDA), with or without non-dialysis CKD | Adults with end-stage renal disease on dialysis |
| Typical billing entity | Office / infusion center / hospital outpatient | Dialysis facility (often under ESRD bundled payment) |
| Dose | 510 mg × 2, 3–8 days apart | Same: 510 mg × 2, 3–8 days apart |
| Drug, NDC | 59338-775-01 (identical) | 59338-775-01 (identical) |
| Medicare ASP+6% Q2 2026 | $0.229/mg | Generally same ASP file entry — verify per quarterly publication |
Dosing & unit math FDA label verified May 2026
From the FDA prescribing information (post-2015 Boxed Warning revision).
Adult dosing — iron-deficiency anemia
- 510 mg IV as a single dose, infused over at least 15 minutes
- Repeat 510 mg dose 3 to 8 days after the initial dose
- Total course: 1,020 mg elemental iron (one 510 mg vial per dose)
- 1 mg = 1 unit; bill 510 units per dose, 1,020 units per full course
- May be readministered (course repeat) if iron-deficiency anemia recurs — verify documentation requirements
Administration requirements (post-2015 label change)
- Dilute 510 mg in 50–200 mL of 0.9% NaCl or 5% Dextrose
- IV infusion over at least 15 minutes — do NOT administer as IV push
- Administer only by trained healthcare professionals with immediate access to resuscitation equipment
- Monitor for hypersensitivity during infusion; observe patient for at least 30 minutes after the end of infusion (vitals, hypotension, signs of anaphylaxis)
- Do not re-administer to patients with prior hypersensitivity to any IV iron product
Worked example — full course billing for IDA non-ESRD
Drug units billed per dose: 510 (Q0138)
HCPCS: Q0138 · Modifier: JZ · Vials: 1 × 510 mg (no waste)
Admin: 96365 (therapeutic IV, ≥15 min infusion)
# Per-course totals
Total doses: 2
Total drug units billed: 1,020 (2 × 510)
Drug cost per dose (Q2 2026 ASP+6%): ~$116.79
Drug cost per course (Q2 2026 ASP+6%): ~$233.58 before sequestration
Plus 96365 admin per dose × 2 visits
No premedication routinely required
Routine premedication with diphenhydramine or steroids is not required by the label for Feraheme. Some institutions premedicate patients with prior mild infusion reactions, but blanket premedication is not recommended and may mask early signs of true anaphylaxis.
NDC reference FDA NDC Directory verified May 2026
| NDC (10/11-digit) | Package | Use |
|---|---|---|
59338-775-01 / 59338-0775-01 |
510 mg / 17 mL (30 mg/mL) single-dose vial — 1 vial per carton | Standard dose — one vial per dose, two doses per course |
N4 + 11-digit NDC + unit of measure
(ML) + total volume (17 mL per vial) in the shaded portion of CMS-1500 box 24A. Vial-level
NDC formats vary by payer — verify with each payer's claim form instructions.
IV iron class comparison CMS Q2 2026 + FDA labels
Feraheme is one of five major IV irons. Per-mg cost, total dose, and admin time differ materially.
| Drug (generic) | HCPCS | Total iron / course | Per-dose / schedule | Infusion time | Q2 2026 ASP+6% | Notes |
|---|---|---|---|---|---|---|
| Feraheme (ferumoxytol) | Q0138 / Q0139 |
1,020 mg | 510 mg × 2 (3–8 days apart) | ≥15 min | $0.229/mg | Boxed Warning hypersensitivity; affects MRI ≤3 mo; lowest per-mg cost |
| Injectafer (ferric carboxymaltose) | J1439 |
1,500 mg (typical) | 750 mg × 2 (≥7 days apart) | ≥15 min | ~$1.103/mg | Hypophosphatemia risk; widely used; high per-mg cost |
| Monoferric (ferric derisomaltose) | J1437 |
Up to 1,000–1,500 mg | 1,000 mg single dose (or weight-based) | ≥20 min (1,000 mg) | ~$1.10/mg | Single-dose convenience; complete-replacement option |
| Venofer (iron sucrose) | J1756 |
1,000 mg (typical) | 100–200 mg × 5–10 doses | 15–30 min per dose | ~$0.43/mg | Multi-visit; favored in CKD/dialysis; lower per-mg vs Injectafer |
| INFeD (iron dextran) | J1750 |
Total dose calc by formula | Test dose then weight-based total | Slow IV infusion | ~$0.26/mg | Boxed Warning anaphylaxis; oldest product; declining use |
Administration codes CPT verified May 2026
Feraheme is non-chemotherapy. Use therapeutic IV infusion codes, 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 Feraheme. ≥15-minute infusion fits within 1-hour window. |
96366 |
Therapeutic IV infusion, each additional hour | Rarely needed for monotherapy. Pair with 96365 only if extending beyond 1 hour with another infusion. |
96413 / 96415 |
Chemotherapy administration, IV infusion | NOT appropriate. Feraheme is not chemotherapy. Using chemo admin codes will trigger denial or audit. |
96374 |
Therapeutic IV push, single drug | NOT appropriate post-2015. The label requires ≥15-minute infusion; IV push is no longer permitted. |
Modifiers CMS verified May 2026
JZ — required on virtually every Feraheme claim
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. The Feraheme 510 mg dose uses one 510 mg single-dose vial with no waste. JZ applies to virtually every Feraheme claim with the standard 510 mg fixed dose.
JW — rare with fixed 510 mg dosing
JW reports the discarded portion of a single-dose vial. With Feraheme's fixed 510 mg dose using a single 510 mg vial, partial-vial waste is uncommon. JW would only apply in unusual scenarios (e.g., partial dose interrupted by adverse reaction, with documented administration of less than the full 510 mg). One of JZ or JW must be on every Q0138 / Q0139 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 Feraheme, follow your MAC's current 340B modifier policy.
ICD-10-CM by indication FY2026 verified May 2026
Iron-deficiency anemia (IDA), with or without underlying CKD or other contributing condition.
| Indication / context | ICD-10 code | Notes |
|---|---|---|
| Iron-deficiency anemia secondary to blood loss (chronic) | D50.0 | Most common; menorrhagia, GI bleed, etc. |
| Other iron-deficiency anemias | D50.8 | Specified cause not otherwise listed |
| Iron-deficiency anemia, unspecified | D50.9 | When cause is undocumented or unknown |
| Acute posthemorrhagic anemia | D62 | Recent blood loss with iron deficiency |
| Anemia, unspecified | D64.9 | Use only if more specific code not supported |
| Anemia in chronic kidney disease | D63.1 | Pair with N18.x stage when CKD-related |
| Chronic kidney disease (stage) | N18.1–N18.6 | Stage-specific; use with D63.1 for CKD-anemia link |
| End-stage renal disease (use Q0139, not Q0138) | N18.6 + dialysis status | If patient is on dialysis, use Q0139, not Q0138 |
Site of care & place of service Verified May 2026
UnitedHealthcare and several major payers run site-of-care programs for non-emergent IV infusions including IV iron. Office and ambulatory infusion are preferred over HOPD when clinically appropriate.
| Setting | POS | Claim form | Notes |
|---|---|---|---|
| Physician office | 11 | CMS-1500 / 837P | Preferred when resuscitation equipment available |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Preferred |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Disfavored when office/AIC available |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored when office/AIC available |
| Dialysis facility (ESRD) | 65 | UB-04 / 837I | Use Q0139, often under ESRD bundled payment |
Claim form field mapping Verified May 2026
CMS-1500 / 837P submission for non-ESRD Feraheme.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 59338-0775-01 + ML + 17 |
| HCPCS Q0138 + JZ (or Q0139 + JZ for ESRD) | 24D (drug line) | Use Q0138 for non-ESRD; Q0139 for ESRD on dialysis |
| Drug units | 24G | 510 per dose |
| CPT 96365 (admin line) | 24D (admin line) | ≥15 min infusion fits within 1-hour window |
| ICD-10 | 21 | D50.0 / D50.8 / D50.9 / D62 / D63.1 + N18.x as applicable |
| PA number | 23 | Required by most major commercial payers |
Payer policy snapshot Reviewed May 2026
All major commercial payers require PA for IV iron; criteria emphasize IDA dx + lab values + oral iron failure.
| Payer | PA? | Typical criteria | Site-of-care UM |
|---|---|---|---|
| UnitedHealthcare Specialty Med Coverage Policy — IV iron |
Yes | IDA diagnosis + ferritin/TSAT below threshold + documented oral iron failure or intolerance (typically ≥3 month trial unless contraindication) | Yes (Optum site-of-care steering) |
| Aetna CPB IV iron |
Yes | IDA + lab values + oral iron failure; non-preferred status vs Injectafer/Venofer in some plan tiers — verify formulary | Yes for non-emergent IV infusions |
| BCBS plans Vary by plan |
Yes | Generally aligned with payer-specific IV iron LCDs and ACG IDA guidance | Plan-specific |
| Medicare (MAC LCDs) | Generally not | Standard medical necessity: IDA dx with appropriate ICD-10; ESRD patients use Q0139 under bundled payment | N/A |
Step therapy — oral iron first
Most commercial PA policies require documented failure of or intolerance to oral iron (typically a 3-month trial) before approving any IV iron, including Feraheme. Contraindications to oral iron (e.g., active GI bleed, malabsorption, IBD with intolerance) generally satisfy this requirement.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — Q0138
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
Coverage
No NCD specific to ferumoxytol. Coverage falls under MAC LCDs for IV iron and the generic drug-coverage framework. All MACs cover Q0138 for FDA-approved on-label IDA indications with appropriate ICD-10 and documentation.
Code history
- Q0138 — "Ferumoxytol, non-ESRD use, 1 mg"; Q0139 — "Ferumoxytol, ESRD on dialysis, 1 mg"; both permanent codes since shortly after FDA approval (June 2009)
Patient assistance Verify current programs at billing time
- Covis Patient Support / Feraheme support program: verify current support phone and program details with the manufacturer; the program landscape changed when Covis acquired AMAG Pharmaceuticals
- Feraheme co-pay assistance: commercial copay support (eligibility excludes Medicare, Medicaid, and federal program patients)
- Patient assistance program (PAP): free product for uninsured / underinsured patients meeting income requirements
- Foundations: for Medicare patients, refer to PAN, HealthWell, and similar foundations — verify open IDA / IV iron funds quarterly (these funds are intermittent)
Boxed Warning — serious hypersensitivity reactions FDA verified May 2026
Mandatory administration controls (post-2015 label change)
- Infusion duration: at least 15 minutes (no IV push)
- Setting: administer only by trained healthcare professionals with immediate access to resuscitation equipment
- Observation: at least 30 minutes after the end of infusion, monitoring for hypotension, signs of anaphylaxis, and other hypersensitivity manifestations
- Contraindication: do not administer to patients with a history of allergic reaction to any IV iron product
- Increased risk populations: patients with prior IV iron hypersensitivity, multiple drug allergies, or inflammatory conditions are at higher risk
2015 history — why the label changed
Feraheme was originally approved in 2009 with IV push administration over 17 seconds. Following post-marketing surveillance reports of serious hypersensitivity reactions including fatal anaphylaxis, the FDA required a March 2015 label revision adding the Boxed Warning, mandating ≥15-minute infusion, and requiring ≥30-minute observation. This eliminated Feraheme's chair-time advantage relative to other IV irons and reduced uptake at infusion centers, particularly versus Injectafer (which had launched with similar safety profile but newer brand momentum).
MRI imaging interaction — up to 3 months FDA label verified May 2026
Feraheme is unique among IV irons in containing superparamagnetic iron oxide (SPIO) nanoparticles. These particles can affect magnetic resonance imaging for an extended period after administration. T1, T2, and T2*-weighted MRI images can be altered for up to 3 months following the Feraheme dose.
Coordination requirements
- Document Feraheme administration prominently in the medical record with date and dose; flag this in the active medication list and imaging history
- Notify radiology if MRI is being scheduled within 3 months of Feraheme administration
- Consider alternatives: delay non-urgent MRI past the 3-month window, or use alternative imaging modalities (CT, ultrasound) when clinically appropriate
- For urgent MRI within 3 months: radiologist should be aware of Feraheme administration and adjust imaging protocol / interpretation accordingly
- The interaction does not affect non-MRI imaging (CT, X-ray, ultrasound, nuclear medicine)
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong HCPCS (Q0138 vs Q0139) | Non-ESRD billed as Q0139, or ESRD-on-dialysis billed as Q0138 | Verify ESRD/dialysis status. Resubmit with correct code. Q0138 for non-ESRD; Q0139 for ESRD on dialysis. |
| Wrong admin code (chemo) | 96413 billed instead of 96365 | Resubmit with 96365. Feraheme is non-chemotherapy. |
| IV push code billed (96374) | Pre-2015 IV push admin coded after label change | Resubmit with 96365. IV push is no longer label-permitted; admin must be ≥15-minute infusion. |
| JZ missing on claim | Single-dose vial claim without JZ | Resubmit with JZ. Required since 7/1/2023 on every claim with no waste. |
| Lab values not documented | PA submitted without ferritin / TSAT | Submit baseline lab values + oral iron failure documentation. Resubmit PA. |
| Oral iron trial not documented | PA submitted without 3-month oral iron trial / contraindication | Submit oral iron history + reason for failure/intolerance, or documented contraindication (e.g., GI bleed, malabsorption). |
| Site of care | HOPD administration on payer with site-of-care UM | Move to office (POS 11) or AIC (POS 49). Submit medical necessity letter if HOPD required (e.g., resuscitation equipment availability). |
| NDC qualifier / format | Wrong NDC qualifier or 10-digit format | Use N4 + 11-digit NDC: 59338-0775-01 + ML + 17. |
Frequently asked questions
What is the HCPCS code for Feraheme?
Feraheme (ferumoxytol) is billed under two distinct HCPCS codes by indication: Q0138
("Ferumoxytol, non-ESRD use, 1 mg") for IDA in patients without ESRD, and Q0139
("Ferumoxytol, ESRD on dialysis, 1 mg") for ESRD patients on dialysis. Each milligram equals one
billable unit, so the standard 510 mg dose is 510 units. Using the wrong code is one of the most
common Feraheme denial reasons.
How is Feraheme dosed?
Feraheme is dosed as 510 mg IV × 2 doses, 3–8 days apart, for a total course of 1,020 mg elemental iron. Each 510 mg dose must be administered as an IV infusion over at least 15 minutes. Patients must be observed for at least 30 minutes post-infusion. Per-course billing: 1,020 units of Q0138 (or Q0139 for ESRD).
What administration CPT do I use for Feraheme?
CPT 96365 — "Therapeutic IV infusion, up to 1 hour, single or initial substance"
is the primary administration code. Feraheme is non-chemotherapy, so chemo admin codes (96413) are
NOT appropriate. The minimum 15-minute infusion fits within 96365. The mandatory 30-minute
post-infusion observation is bundled into the admin code.
Why is Feraheme infusion at least 15 minutes — wasn't it originally an IV push?
Yes. From 2009 to 2015, Feraheme was approved for IV push administration over 17 seconds. Following post-marketing reports of serious hypersensitivity reactions including fatal anaphylaxis, the FDA required a March 2015 label change mandating Boxed Warning, ≥15-minute IV infusion, and ≥30-minute post-infusion observation. This change materially increased clinic chair time and reduced uptake versus Injectafer and Monoferric.
Does Feraheme affect MRI imaging?
Yes. Feraheme contains superparamagnetic iron oxide nanoparticles that can alter T1, T2, and T2*-weighted MRI images for up to 3 months after administration. Document Feraheme administration date and dose in the medical record so radiology is aware. Coordinate with radiology if MRI is needed within 3 months. This interaction is unique to Feraheme among IV irons.
What is the Medicare reimbursement for Q0138?
For Q2 2026, the Medicare Part B payment limit for Q0138 is $0.229 per mg (ASP + 6%). The standard 510 mg dose reimburses at approximately $116.79 per infusion; the full course (2 × 510 mg = 1,020 mg) at approximately $233.58. Feraheme is the lowest per-mg cost among major IV irons. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%. ASP is updated quarterly by CMS.
What is the difference between Q0138 and Q0139?
Same drug (ferumoxytol), different patient population. Q0138 is for non-ESRD use — IDA in patients with normal renal function or non-dialysis CKD. Q0139 is for ESRD patients on dialysis (typically billed by the dialysis facility under the ESRD bundled payment system, though some scenarios allow separate billing). Using the wrong code is a top denial reason. Verify the patient's ESRD/dialysis status before coding.
Do I bill JZ or JW for Feraheme?
Bill JZ on virtually every Feraheme claim. The 510 mg dose uses one 510 mg single-dose
vial with zero waste. JW only applies in the rare scenario of partial-vial waste, which
is uncommon with the fixed 510 mg dosing. One of JZ or JW must be on every Q0138 / Q0139 claim per
CMS's July 2023 single-dose container policy.
How does Feraheme compare to Injectafer, Monoferric, Venofer, and INFeD?
Feraheme has the lowest per-mg ASP+6% (~$0.229/mg) among major IV irons but carries a Boxed Warning for hypersensitivity and the 3-month MRI imaging effect. Injectafer (J1439) is the most-used premium IV iron at ~$1.103/mg with hypophosphatemia risk. Monoferric (J1437) offers single-dose convenience at similar cost. Venofer (J1756) is the multi-visit workhorse, common in CKD/dialysis. INFeD (J1750) is the oldest product, with declining use due to anaphylaxis risk. See class comparison table above.
Source documents
- DailyMed — FERAHEME (ferumoxytol) Prescribing Information
- FDA Drug Safety Communication (March 2015) — Feraheme Boxed Warning + Administration Change
- CMS — Medicare Part B Drug ASP Pricing File
- CMS HCPCS — Q0138 / Q0139 descriptors
- UnitedHealthcare — Specialty Medical Coverage Policy: IV Iron
- Aetna CPB — Intravenous Iron Therapy
- FDA National Drug Code Directory — NDC 59338-775-01
- KDIGO Clinical Practice Guideline for Anemia in CKD
- ACG Clinical Guideline — Diagnosis and Management of Iron Deficiency Anemia
About this page
We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.
Found an error? Email hello@carecostestimate.com.
Refresh cadence
| Element | Cadence | How it's refreshed |
|---|---|---|
| Medicare ASP pricing | Quarterly | Auto-bound to CareCost ASP layer; updates on CMS file release. |
| Payer policies (UHC, Aetna, BCBS) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules | Annual | Reviewed against CMS HCPCS quarterly files and AMA CPT releases. |
| NDC, dosing, FDA label, Boxed Warning | Event-driven | Tied to manufacturer document version + FDA label revision date. |
| IV iron class comparison | Annual | Reviewed against CMS Part B ASP file and current FDA labels for class peers. |
Reviewer
Change log
- — Initial publication. ASP data: Q2 2026. Manufacturer: Covis Pharma (post-AMAG acquisition). FDA label reflects post-2015 Boxed Warning + ≥15-minute infusion mandate. IV iron class comparison includes Injectafer, Monoferric, Venofer, INFeD. Q0138 vs Q0139 distinction emphasized.
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. Boxed Warning and administration requirements are taken from the post-2015 FDA-approved label. We do not paraphrase from billing-software vendor blogs.