HCPCS
J1439
1 mg = 1 unit
Phase 1
Identify what you're billing
Confirm the right code, dose, monitoring, and indication-specific PA criteria.
IV iron class — how Injectafer compares CMS ASP Q2 2026
Five major IV iron products. Injectafer holds the largest US market share, primarily because of its 750 mg dose-per-visit advantage among the modern multi-dose products.
| Brand (generic) | HCPCS | Manufacturer | Dose / visit | Total course | ASP+6% per mg |
|---|---|---|---|---|---|
| Injectafer (ferric carboxymaltose) | J1439 |
American Regent / CSL Vifor | 750 mg in ~15 min | 1,500 mg (2 doses, ≥7 days apart) | $1.103 (Q2 2026) |
| Monoferric (ferric derisomaltose) | J1437 |
Pharmacosmos | 1,000 mg in ~20 min | 1,000 mg (single dose) | ~$1.10 (verify CMS file) |
| Feraheme (ferumoxytol) | Q0138 (non-ESRD) |
AMAG / Covis | 510 mg in ~15 min | 1,020 mg (2 doses, 3-8 days apart) | ~$1.04 (verify CMS file) |
| Venofer (iron sucrose) | J1756 |
American Regent | 200–300 mg per visit | 1,000 mg total over 5+ visits (non-dialysis) | ~$0.40 (verify CMS file) |
| INFeD (iron dextran) | J1750 |
Allergan / AbbVie | Up to total dose infusion (TDI) per protocol | Calculated; requires test dose | ~$0.30 (verify CMS file) |
Why Injectafer dominates US infusion centers: two visits to deliver a 1,500 mg course
(versus 5+ for Venofer) translates to fewer chair-time hours, fewer claim cycles, and faster
clinical resolution of iron deficiency. Monoferric is the only single-dose competitor, but Injectafer
was first to market with the high-dose multi-vial workflow and retains the largest installed prescriber
base.
Per-mg ASP is similar across the modern products. The economic story is admin time +
chair efficiency, not drug cost per mg. Compare against Venofer's lower per-mg cost only if your
infusion suite has spare capacity for the multi-visit regimen.
Dosing & unit math FDA label 2024 revision
From the current FDA prescribing information (NDA 203565), revised 2024 with pediatric indication and strengthened hypophosphatemia warning.
Adults ≥50 kg
- 750 mg IV × 2 doses, separated by ≥7 days (total 1,500 mg elemental iron per course)
- Each dose: IV infusion over ~15 minutes (in 250 mL 0.9% NaCl, max concentration 2–4 mg/mL) or undiluted slow IV push at ≤100 mg/min
- 1 mg = 1 unit — bill 750 units per dose
- May repeat course if iron deficiency recurs
Adults <50 kg
- 15 mg/kg IV × 2 doses, separated by ≥7 days (max 750 mg per dose)
- Bill the actual mg administered (e.g., 45 kg patient = 675 mg per dose = 675 units billed)
Pediatric (≥1 year, added 2024)
- 15 mg/kg IV × 2 doses, separated by ≥7 days (max 750 mg per dose)
- Bill the actual mg administered
- Pediatric weight-based doses below the 750 mg vial size will produce partial-vial waste — bill JW with discarded units (see Modifiers)
Worked example — standard adult IDA course (750 mg × 2)
# Course = 2 doses, 7+ days apart
Drug units billed per dose: 750 (J1439)
HCPCS: J1439 · Modifier: JZ · Vials: 1 × 750 mg
Admin: 96365 (~15-min infusion)
# Course totals
Total doses: 2
Total drug units billed: 1,500 (2 × 750)
Total drug cost (Q2 2026 ASP+6%): ~$1,654.50 before sequestration
Drug units billed per dose: 750 (J1439)
HCPCS: J1439 · Modifier: JZ · Vials: 1 × 750 mg
Admin: 96365 (~15-min infusion)
# Course totals
Total doses: 2
Total drug units billed: 1,500 (2 × 750)
Total drug cost (Q2 2026 ASP+6%): ~$1,654.50 before sequestration
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 |
|---|---|---|
0517-0650-01 / 00517-0650-01 |
750 mg / 15 mL (50 mg/mL elemental iron) single-dose vial — 1 vial per carton | Standard 750 mg dose; one vial per dose for adult dosing |
Use the carton-level NDC on the claim. American Regent labeler code is 0517. Confirm
the 11-digit format your payer expects (some require the 5-4-2 padded form
00517-0650-01).
Use N4 qualifier in box 24A shaded area on CMS-1500.
Historical 100 mg / 2 mL formulation discontinued in the US. Earlier US Injectafer
cartons used a 750 mg dose split across two 15 mL vials (older FDA label revisions referenced this).
Current US supply is the single 750 mg / 15 mL vial.
Hypophosphatemia — 2024 W&P strengthening FDA 2024 label revision
The most consequential label change in Injectafer history for billing operations — payers are now requiring monitoring documentation.
In 2024, the FDA strengthened Injectafer's Warnings & Precautions section for severe and persistent hypophosphatemia. Multiple post-marketing reports and head-to-head studies (notably PHOSPHARE-IDA) showed substantially higher rates of hypophosphatemia with ferric carboxymaltose compared to other IV irons, with rare reports of hypophosphatemic osteomalacia and pseudofractures in patients receiving repeated courses.
Monitor serum phosphate before each course and during therapy in patients at risk
(chronic recurrent need, malnutrition, hyperparathyroidism, vitamin D deficiency, concurrent oral
phosphate-binding therapy). Replace phosphate orally or IV when clinically indicated. Consider
switching to a non-ferric carboxymaltose IV iron for patients with persistent hypophosphatemia despite
replacement.
Payer impact
- UnitedHealthcare — some plans now require documentation of pre-course phosphate level on PA renewals after the first course of Injectafer.
- Several BCBS plans — medical policy updates in 2024-2025 added phosphate monitoring as a continuation criterion.
- Medicare MACs — no NCD/LCD changes specifically targeting phosphate documentation as of May 2026, but expect MAC LCD updates as the warning matures.
Documentation tip: capture the most recent serum phosphate result in the chart before
each Injectafer course and reference it in the PA submission. This prevents continuation denials on
repeat courses.
Heart failure indication (2023 expansion) FDA approval 2023
The single largest billing growth driver for Injectafer post-2023.
In 2023 the FDA approved Injectafer for iron deficiency in adults with NYHA Class II or III heart failure and reduced ejection fraction (HFrEF). The expansion was supported by the HEART-FID program and aligned with the European AFFIRM-AHF and IRONMAN findings that IV iron repletion improves quality of life and reduces HF hospitalization risk in iron-deficient HFrEF patients.
Clinical PA criteria (typical)
- Documented NYHA Class II or III HF with reduced ejection fraction (LVEF threshold typically <45% or <50%; verify per payer)
- Iron deficiency confirmed by ferritin <100 ng/mL or ferritin 100–299 ng/mL with TSAT <20%
- On guideline-directed medical therapy (GDMT) for HF
- Cardiology or HF specialist as prescriber (some payers)
Coding pairing — both diagnosis families on the claim
- Heart failure:
I50.x(e.g., I50.22 chronic systolic HF, I50.32 chronic diastolic HF, I50.42 chronic combined HF, I50.9 HF unspecified) - Iron deficiency:
D50.0,D50.8,D50.9 - Both required for HF-indication PA approval
Cardiology vs. heme/GI workflow: HF infusion centers within cardiology practices have
driven the largest J1439 volume growth since 2023. Many cardiology offices now have dedicated infusion
rooms purely for IV iron and IV diuretics. The 15-minute Injectafer push fits cleanly into existing
cardiology workflows.
Pediatric indication (2024 expansion) FDA approval 2024
Injectafer is now approved for ages 1 year and older with IDA.
In 2024 the FDA approved Injectafer for iron-deficiency anemia in pediatric patients aged 1 year and older who are intolerant or unresponsive to oral iron, or who have non-dialysis-dependent CKD. Previously, Venofer (iron sucrose) was the dominant pediatric IV iron in the US.
Pediatric PA criteria (typical)
- Age ≥1 year
- IDA confirmed by Hgb threshold (varies by age) + ferritin <15–30 ng/mL (varies by payer)
- Documented oral iron failure or intolerance, OR non-dialysis-dependent CKD
- Pediatric heme, GI, or nephrology prescriber preferred by some payers
Pediatric billing notes
- Dose: 15 mg/kg IV × 2 doses, separated by ≥7 days, max 750 mg per dose
- Bill actual mg administered (not rounded)
- Patients <50 kg will produce partial-vial waste — bill JW for the discarded portion alongside JZ-style admin line for the units administered
- ICD-10: same D50.x codes; pediatric weight or growth charts in the encounter note support medical necessity
Phase 2
Code the claim
Therapeutic IV admin (96365) is standard. Site-pushed administration uses 96374. Don't bill chemo admin codes.
Administration codes CPT verified May 2026
Injectafer 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 Injectafer infusion. ~15-minute infusion fits within the 1-hour 96365 window. Most common admin code in practice. |
96366 |
Each additional hour of therapeutic IV infusion | Rarely needed for the 15-minute Injectafer infusion; not applicable for typical IV iron protocols. |
96374 |
Therapeutic IV push, single or initial drug | Use when site administers Injectafer as undiluted 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. Injectafer is non-chemotherapy; do not use chemo admin codes. |
Push vs infusion: the FDA label allows undiluted slow IV push at ≤100 mg/min for the
750 mg dose (~7.5 minutes). Many infusion centers still dilute and run as a 15-minute infusion to align
with the broadly accepted 96365 admin. Choose your billing pattern (96365 vs 96374) consistently per
site and confirm with each major payer.
Modifiers CMS verified May 2026
JZ — required on virtually every adult claim
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. The standard Injectafer 750 mg adult dose uses one full 750 mg single-dose vial with zero waste, so JZ applies on virtually every adult claim with the full-vial dose.
JW — weight-based pediatric and sub-50-kg dosing
JW reports the discarded portion of a single-dose vial. For Injectafer, JW only applies when weight-based dosing produces partial-vial waste. Example: a 30 kg pediatric patient receiving 450 mg (15 mg/kg) uses one 750 mg vial and discards 300 mg — bill JW with 300 units of waste on a separate claim line. One of JZ or JW must be on every J1439 claim.
Common error: failing to bill the wasted units on weight-based pediatric or sub-50-kg
adult doses. CMS audits often catch this — bill the JW line with the actual discarded units
alongside the admin line for the units administered. Wasted drug is reimbursable but must be reported.
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 Injectafer, follow your MAC's current 340B modifier policy. American Regent's billing guide does not provide 340B-specific instructions.
ICD-10-CM by indication FY2026 verified May 2026
Three indication families. Use the most specific code supported by encounter documentation; HF indication requires both an HF code and an IDA code on the claim.
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) |
N18.6 (ESRD) and dialysis-dependent CKD are NOT Injectafer indications per the current
FDA label. The label specifies non-dialysis-dependent CKD. Dialysis patients should be billed under
ESRD bundled payment and use Venofer or Feraheme per CMS ESRD policy.
HF + IDA — both code families required
| Code | Description |
|---|---|
I50.20–I50.23 | Systolic (HFrEF) heart failure |
I50.30–I50.33 | Diastolic (HFpEF) heart failure (note: Injectafer FDA approval is HFrEF) |
I50.40–I50.43 | Combined systolic + diastolic HF |
I50.9 | Heart failure, unspecified |
+ D50.x | Iron deficiency anemia code from above |
Multi-indication matrix: a single patient may have CKD + HF + IDA. Code all three
families that apply. Most major payers will approve under whichever indication has the cleanest
documentation; PA reviewers prefer indication-specific clarity over multiple weaker pathways.
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.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Physician office (heme, GI, OB-GYN, cardiology, 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 after first course on commercial plans |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored after first course on commercial plans |
| Patient home | 12 | CMS-1500 (with home infusion) | Possible via specialty home infusion vendors; rare |
Cardiology/nephrology in-office advantage: the 15-minute Injectafer push fits cleanly
into existing physician office workflows without requiring an infusion-suite chair, which makes
cardiology and nephrology offices structurally cost-advantaged for IV iron delivery in 2026.
Claim form field mapping American Regent 2025
From American Regent / Injectafer HCP coding & coverage materials.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 00517-0650-01 + ML + 15 (mL) for 750 mg dose |
| HCPCS J1439 + JZ (or JW for waste) | 24D (drug line) | JZ on virtually every adult full-vial claim |
| Drug units | 24G | 750 (full vial) or actual mg administered for weight-based |
| CPT 96365 (admin line) | 24D (admin line) | Or 96374 if administered as IV push |
| ICD-10 | 21 | Indication-specific (D50.x for IDA; N18.x + D63.1 for CKD; I50.x + D50.x for HF) |
| PA number | 23 | Required by all major commercial payers |
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 Injectafer on labs (ferritin/TSAT), oral iron history, and indication-specific specialist consult.
| Payer | PA? | Lab thresholds | Specialist requirement |
|---|---|---|---|
| UnitedHealthcare IV Iron Therapy LCD/medical drug policy |
Yes | Ferritin <100 ng/mL OR TSAT <20%; Hgb threshold per indication (typically <10 g/dL for IDA) | Heme, GI, OB-GYN, cardiology, or nephrology often required; oral iron failure/intolerance documentation |
| Aetna CPB IV Iron Replacement |
Yes | Same range as UHC; Aetna explicitly cites ferritin <100 OR TSAT <20% in CPB | Specialist preferred but not strict; oral iron failure/intolerance required |
| BCBS plans Vary by plan |
Yes | Generally aligned with KDIGO IDA / CKD anemia and ESC HF guidelines | Plan-specific; phosphate monitoring increasingly required on continuation |
| Medicare (MAC LCDs) No NCD; MAC discretion |
No (PA not required, but documentation expected) | Indication-appropriate workup in chart | None |
Step therapy
Most commercial payers require documented oral iron failure or intolerance before approving any IV iron product (Injectafer, Monoferric, Feraheme, Venofer). Some plans also impose intra-class step therapy — preferring Venofer (lowest per-mg cost) before Injectafer or Monoferric. Verify the payer's IV iron formulary tier before prescribing.
Phosphate monitoring (continuation)
After the 2024 W&P strengthening, several payers now require pre-course serum phosphate documentation on continuation PAs after the first course. Capture the phosphate result in the chart before each repeat course.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J1439
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$1.103
per mg / per unit
750 mg dose
$827.25
750 units × ASP+6%
Full course (1,500 mg)
$1,654.50
2 doses × 750 units
Annualized cost (one course/year typical): 1,500 mg per course at Q2 2026 ASP+6% =
~$1,654.50/year per patient on a single course. Patients with recurrent iron deficiency may receive
2 courses/year (~$3,300). After ~2% sequestration: ~$1,621/course actual paid.
Coverage
No NCD specific to ferric carboxymaltose. Coverage falls under MAC LCDs for IV iron therapy and the generic drug-coverage framework. All MACs cover J1439 for FDA-approved on-label indications with appropriate ICD-10 documentation.
Code history
- J1439 — permanent code; descriptor "Injection, ferric carboxymaltose, 1 mg" (1 unit = 1 mg elemental iron)
- Active long enough that all major commercial payers maintain Injectafer-specific medical drug policies
Patient assistance — American Regent American Regent verified May 2026
- Injectafer Patient Support / Co-Pay Program: 1-844-688-9591 — benefits investigation, prior authorization assistance, appeal support, commercially-insured copay assistance
- American Regent Patient Assistance: free product for uninsured / underinsured patients meeting income requirements (administered through American Regent's PAP)
- Foundations: for Medicare patients with IDA secondary to GI bleed or chronic disease, refer to PAN, HealthWell, NeedyMeds — verify open IDA / CKD / HF funds quarterly
- Web: injectafer.com
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J1439 pre-loaded.
Phase 4
Fix problems
Top denials: missing oral iron failure documentation, wrong admin code, missing phosphate on continuation.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| 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 (HF, CKD, GI bleed). |
| Wrong admin code (96413) | Chemo IV billed instead of therapeutic IV | Resubmit with 96365 (or 96374 for push). Injectafer is non-chemotherapy. |
| JZ missing on adult claim | Single-dose vial claim without JZ | Resubmit with JZ. Required since 7/1/2023 on every claim with no waste. |
| JW missing on weight-based dose | Wasted drug not reported on pediatric or sub-50-kg dose | Add JW line with discarded units. JZ-style admin line for the units administered; JW line for waste. |
| HF indication missing IDA code | Only I50.x billed without D50.x pair | Resubmit with both I50.x and D50.x codes. HF indication PA requires both. |
| Continuation denied — no phosphate documentation | Repeat course PA submitted without serum phosphate | Submit pre-course serum phosphate result. Some payers added this requirement after the 2024 W&P strengthening. |
| 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. |
| Step therapy (Venofer first) | Plan requires lower-cost IV iron before Injectafer | Submit Venofer failure / intolerance documentation, or pursue formulary exception based on dose-per-visit advantage in HF or chair-time-limited settings. |
| Wrong indication (ESRD/dialysis-dependent CKD) | J1439 billed for dialysis patient | Switch to ESRD-bundled IV iron (Venofer/Feraheme) per CMS policy. Injectafer is non-dialysis-dependent CKD only. |
Frequently asked questions
What is the HCPCS code for Injectafer?
Injectafer (ferric carboxymaltose IV) is billed under HCPCS J1439 — "Injection,
ferric carboxymaltose, 1 mg." Each milligram of elemental iron equals one billable unit, so the
standard 750 mg dose is billed as 750 units. A complete course is two 750 mg doses separated by at
least 7 days, totaling 1,500 units billed across two encounters.
How many units do I bill for an Injectafer dose?
Bill 750 units of J1439 per 750 mg dose for adults ≥50 kg. For
patients <50 kg, dose is 15 mg/kg × 2 — bill the actual mg administered. Pediatric
patients ≥1 year follow the same 15 mg/kg × 2 schedule, capped at 750 mg per dose.
What administration CPT do I use for Injectafer?
CPT 96365 — "Therapeutic, prophylactic, or diagnostic IV infusion, up to 1 hour" is
the most common admin code. Standard Injectafer infusion is ~15 minutes for 750 mg, fitting within the
1-hour 96365 window. Sites administering by slow IV push may bill 96374 ("IV push, single
drug"); verify with payer policy. Do NOT bill 96413 (chemotherapy admin) — Injectafer is
non-chemotherapy.
Do I bill JZ or JW for Injectafer?
Bill JZ on virtually every Injectafer claim. Injectafer ships in single-dose 750 mg/15 mL
vials. The standard 750 mg adult dose uses one full vial with zero waste, so JZ applies. JW
is rarely needed because most adult patients receive the full 750 mg vial; pediatric or sub-50-kg
weight-based dosing may produce partial-vial waste — bill JW with the discarded units on a
separate line in those cases. One of JZ or JW must be on every J1439 claim per CMS's July 2023
single-dose container policy.
What is the Medicare reimbursement for J1439?
For Q2 2026, the Medicare Part B payment limit for J1439 is $1.103 per mg (ASP + 6%). The standard 750 mg dose reimburses at approximately $827.25 per infusion, with a complete two-dose course totaling approximately $1,654.50 in drug cost. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
What indications does Injectafer cover?
Injectafer is FDA-approved for: (1) iron-deficiency anemia (IDA) in adults intolerant or unresponsive to oral iron, or with non-dialysis-dependent CKD; (2) IDA in pediatric patients aged 1 year and older (added 2024); (3) iron deficiency in adults with NYHA Class II/III heart failure and reduced ejection fraction (added 2023). The HF expansion has driven significant volume growth in cardiology infusion centers.
Does Injectafer require monitoring for hypophosphatemia?
Yes. In 2024 the FDA strengthened Injectafer's label with a warning about severe and persistent hypophosphatemia, which can occur after dosing and may require oral or IV phosphate replacement. The label now recommends monitoring serum phosphate before each course and during therapy in patients at risk. Several payers — including UnitedHealthcare and some BCBS plans — now require documentation of phosphate monitoring in PA renewals after the first course.
How does Injectafer compare to other IV irons?
Injectafer (J1439, ferric carboxymaltose) competes with Monoferric (J1437, ferric derisomaltose, single 1,000 mg dose), Feraheme (Q0138, ferumoxytol, 510 mg × 2), Venofer (J1756, iron sucrose, 200–300 mg multiple doses), and INFeD (J1750, iron dextran, requires test dose). Injectafer holds the largest US market share for adult IV iron and offers the highest dose-per-visit advantage among multi-dose products (750 mg in 15 minutes), which translates to fewer infusion-suite visits than Venofer or Feraheme.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- DailyMed — INJECTAFER (ferric carboxymaltose) Prescribing Information
- Injectafer HCP / patient site (American Regent)
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — HCPCS J1439 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
- ESC — Heart Failure Guidelines (iron deficiency in HFrEF)
- FDA approval announcements — 2023 HF iron deficiency, 2024 pediatric IDA, 2024 hypophosphatemia W&P
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) + phosphate monitoring 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, hypophosphatemia warning | Event-driven | Tied to manufacturer document version + FDA label revision date. Last major label update: 2024 (pediatric + hypoP W&P). |
| IV iron class comparison (per-mg ASP across products) | Annual | Re-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.
Change log
- — Initial publication. ASP data: Q2 2026. Manufacturer source: American Regent 2025 materials. FDA label: 2024 revision (NDA 203565) including pediatric expansion (ages ≥1 year) and strengthened hypophosphatemia W&P. 2023 HF iron deficiency indication included. IV iron class comparison covers Injectafer / Monoferric / Feraheme / Venofer / INFeD.
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.