Home › Drugs › Cutaquig (J1551)

Cutaquig (immune globulin SC, 16.5%) — HCPCS J1551

Octapharma USA · 1 g/6 mL, 2 g/12 mL, 4 g/24 mL, 8 g/48 mL single-dose vials (165 mg/mL = 16.5%) · Subcutaneous pump infusion · Primary humoral immunodeficiency (adults + pediatric ≥2 yr)

Cutaquig is the only major SCIG at 16.5% (165 mg/mL) — every other commonly used SCIG is 20%. Billed under HCPCS J1551 at 100 mg per unit. This is NOT the IVIG 500 mg/unit basis — the same unit-math trap that kills Hizentra/Cuvitru/Xembify claims kills Cutaquig claims. SC infusion runs via mechanical pump, typically weekly at home after patient training. Admin codes are 96369 + 96370 + 96371 (SC pump infusion family) — not 96365/96366 (those are IV). Q2 2026 Medicare reimbursement: $13.927/100 mg unit (~$139/g; $1,392.70 per 10 g weekly dose) — currently the lowest-cost SCIG by Medicare ASP+6%.

✓ASP data:Q2 2026 (live)
✓Payer policies:verified May 2026
✓Manufacturer guide:Octapharma OneSource 2026
✓FDA label:verified May 2026
✓Page reviewed:

Instant Answer — the 5 things you need to bill J1551

HCPCS
J1551
1 unit = 100 mg (NOT 500 mg)
Typical dose
100 units
10 g weekly SC (PI maintenance)
Modifier
JZ
Single-dose vial, no waste
Admin CPT
96369
+ 96370 / 96371 (SC pump — NOT 96365)
Medicare ASP+6%
$13.927
per 100 mg, Q2 2026 · $1,392.70/10 g
HCPCS descriptor
J1551 — "Inj cutaquig 100 mg" 100 mg/unit
Unit basis trap
1 unit = 100 mg of IgG. Different from IVIG (J1459/J1568/J1569 etc.) which use 500 mg/unit. A 10 g (10,000 mg) dose = 100 units of J1551 — not 20 units (IVIG basis), not 10,000 units (per-mg basis).
Concentration differentiator
16.5% (165 mg/mL) — Cutaquig is the only major SCIG not at 20% (200 mg/mL). Larger infusion volume per dose vs Hizentra/Cuvitru/Xembify; some patients tolerate 16.5% better, others prefer 20% for shorter sessions. See concentration differentiator.
Indication
Primary humoral immunodeficiency (PI) — adults + pediatric ≥2 yr. No CIDP indication (unlike Hizentra J1559 and HyQvia J1575).
Dosing — PI (post-IVIG conversion)
Weekly Cutaquig = (prior monthly IVIG dose × 1.37) ÷ 4; typically 100–200 mg/kg per week SC
Frequency options
Weekly (most common), biweekly, or daily/frequent (more often than weekly) per FDA label and patient preference
Vials
1 g/6 mL, 2 g/12 mL, 4 g/24 mL, 8 g/48 mL single-dose vials (165 mg/mL = 16.5%)
Stabilizer
Maltose-stabilized. Caution with non-glucose-specific glucose meters; contraindicated in hereditary fructose intolerance. (Hizentra = proline; Cuvitru/Xembify = glycine.)
Route
Subcutaneous infusion via mechanical pump (typically abdomen, thigh, hip; multiple SC sites simultaneously); session length depends on volume; rapid-push manual SC also acceptable per label
Setting
Home self-administration is the norm after pump training (POS 12); ambulatory infusion (POS 49) and office (POS 11) used during training
Manufacturer
Octapharma USA — sister product to Octagam IVIG (J1568)
FDA approval
PI: 2018 (Cutaquig BLA); pediatric ≥2 yr label inclusive
Calculate patient estimate → Read full reference Open 1-page cheat sheet
⚠️
UNIT-BASIS TRAP — J1551 = 100 mg per unit, not 500 mg. Cutaquig is a SCIG code with a 100 mg/unit basis. It does NOT use the IVIG 500 mg/unit basis (Privigen J1459, Octagam J1568, Gammagard Liquid J1569, Gamunex-C J1561, etc.). A 10 g weekly Cutaquig dose bills as 100 units of J1551. Billing it as 20 units (IVIG math) under-reports drug by 5x and triggers an underpayment that auditors will eventually catch. Billing it as 10,000 units (per-mg math) over-reports by 100x and triggers an automatic denial. Verify the unit math on every claim.
📊
Concentration differentiator — Cutaquig is the only non-20% SCIG. At 16.5% (165 mg/mL), Cutaquig has 17.5% lower IgG/mL than the 20% (200 mg/mL) products (Hizentra J1559, Cuvitru J1555, Xembify J1558). A 10 g dose = ~61 mL of Cutaquig vs ~50 mL of a 20% SCIG. The practical impact: more SC sites per session, longer per-session infusion time, or biweekly → weekly schedule conversion. For patients with persistent local site reactions on a 20% SCIG, switching to 16.5% Cutaquig is a common clinical strategy because the lower-viscosity solution distends the SC tissue more gently. See concentration differentiator.
💰
Lowest-cost SCIG by Medicare ASP+6%. At $13.927/100 mg unit (Q2 2026), Cutaquig is currently the cheapest of the major SCIG products: Hizentra ~$14.515, Xembify in the $15 range, Cuvitru in the $17 range. For payers running cost-conscious SCIG policies, 340B-leveraged practices, or PI patients on long-horizon therapy, the per-gram economics increasingly favor Cutaquig. See Medicare reimbursement for current per-gram comparison.
⚠️
SC pump admin codes — 96369 / 96370 / 96371, NOT 96365 or 96372. Cutaquig is delivered via a mechanical infusion pump. Use the SC infusion family: 96369 (initial up to 1 hour, includes pump set-up + first SC site), 96370 (each additional hour), and 96371 (additional pump set-up with new SC site, list separately). Because Cutaquig is 16.5% (larger volume), 96370 and 96371 are billed more often than for 20% SCIGs. Do NOT bill 96365/96366 — those are IV; Cutaquig is not IV. Do NOT bill 96372 — that is a one-shot SC injection, not a pump-driven SCIG infusion.
🏠
Home self-administration is the dominant Cutaquig setting. After 1–3 in-clinic training infusions, most Cutaquig patients self-infuse at home with a portable mechanical pump. This drives a medical-benefit (Part B + home-infusion services) vs DME/specialty-pharmacy benefit billing decision that varies by payer. Map the benefit before the first home infusion — see site of care & place of service.
Phase 1 Identify what you're billing SCIG vs IVIG is the first decision; concentration choice (16.5% vs 20%) is the second.

SCIG (Cutaquig) vs. IVIG — the foundational billing distinction FDA + payer verified May 2026

Same therapeutic class (immune globulin), different molecules in the bottle, very different billing infrastructure.

Immune globulin therapy splits into two delivery routes: intravenous (IVIG — Privigen, Gammagard Liquid, Octagam, Gamunex-C, etc.) and subcutaneous (SCIG — Hizentra, Cuvitru, Cutaquig, Xembify, plus Gamunex-C which is IV+SC dual-approved, and HyQvia which uses recombinant hyaluronidase to enable larger-volume facilitated SC). They are clinically interchangeable for stable patients with primary humoral immunodeficiency, but the billing infrastructure differs from the unit basis on up.

Cutaquig (SCIG, 16.5%)IVIG (Octagam / Privigen / Gammagard Liquid / Gamunex-C)
HCPCSJ1551J1568 Octagam, J1459 Privigen, J1569 Gammagard Liquid, J1561 Gamunex-C
Unit basis100 mg = 1 unit500 mg = 1 unit
Concentration16.5% (165 mg/mL) — lower than other SCIGs5% or 10% (50 or 100 mg/mL)
RouteSubcutaneous, mechanical pumpIntravenous, gravity or pump
Admin CPT96369 + 96370 + 9637196365 + 96366
Typical session length90–180 min (longer than 20% SCIGs due to larger volume)2–4 hours (rate titration required)
FrequencyWeekly (or biweekly / daily push / more frequent than weekly)Every 3–4 weeks
Dominant sitePatient home (POS 12) after trainingAmbulatory infusion (POS 49) or hospital outpatient (POS 19/22)
IgG kineticsFlat trough (steady-state)Peaks & troughs (post-infusion peak, pre-next-infusion trough)
Side-effect profileLocal site reactions; very rare systemicHeadache, fever, chills (rate-related); rare TRALI / aseptic meningitis / thrombosis
FDA-approved indicationsPrimary humoral immunodeficiency (adult + ped ≥2)PI + ITP (most) + CIDP (Privigen, Gamunex-C) + dermatomyositis (Octagam 10%)
Payer steerage (UHC, several BCBS)Often preferred for stable PI; cost-conscious policies may favor Cutaquig as lowest-cost SCIGOften required to step through SCIG trial first (chronic stable patients)
Major payer trend (2024–2026): UnitedHealthcare, Aetna, and several BCBS plans have added SCIG-preference language to their immune globulin LCDs. For chronic stable PI, the plan may require a documented SCIG trial (or contraindication) before approving ongoing IVIG. Cutaquig's lowest-cost SCIG positioning makes it an increasingly common payer-preferred SCIG on chronic PI — bill the IVIG-to-SCIG transition cleanly (see conversion math).
Cutaquig has no FDA-approved CIDP indication. If the patient is on SCIG for CIDP maintenance, the only SCIGs with FDA-approved CIDP indications are Hizentra (J1559, since March 2018) and HyQvia (J1575, expanded to CIDP in 2024). Off-label SCIG use for CIDP with Cutaquig will face PA denials.

16.5% vs 20% concentration — what changes FDA labels verified May 2026

Cutaquig is the only major SCIG at 16.5%. The other three (Hizentra, Cuvitru, Xembify) are all 20%. Here is what that practically means for the infusion and the claim.

Cutaquig (16.5% / 165 mg/mL)20% SCIGs (Hizentra, Cuvitru, Xembify) — 200 mg/mL
Volume per 10 g dose~60.6 mL~50 mL
Volume per 5 g dose~30.3 mL~25 mL
Volume premium vs 20%+21% larger volume(baseline)
Typical SC sites per sessionOften 2–4 sites for >5 gOften 1–2 sites for >5 g
Typical session length90–180 min60–120 min
Tissue distension / viscosityLower viscosity, gentler distensionHigher viscosity, more aggressive distension
Local site reactionsMay be better tolerated in patients with persistent reactions on 20%Some patients report more induration / itch
Patient time burdenLonger per session (or more sessions)Shorter per session
Pump compatibilitySame mechanical pumps (Freedom60, CRONO-S, etc.)Same
96370 / 96371 billing frequencyHigher (more sites, longer sessions)Lower (often single site, single hour)

Clinical scenarios where 16.5% Cutaquig is preferred

  • Persistent local site reactions on 20% SCIG. Switching from 20% to 16.5% reduces tissue distension and viscosity; documented strategy for patients with intolerable induration, itching, or pain at 20% sites.
  • Pediatric patients with limited SC tissue. Smaller children may absorb the larger volume better at lower concentration distributed across more sites.
  • Hyperprolinemia. Avoid Hizentra (proline-stabilized); Cutaquig (maltose) or Cuvitru/Xembify (glycine) are alternatives.
  • Cost-driven payer policy or 340B economics. Cutaquig is the lowest-cost major SCIG by Medicare ASP+6% — preferred SCIG on some commercial cost-conscious policies and may have favorable 340B per-gram acquisition vs other SCIGs.

Clinical scenarios where a 20% SCIG is preferred over Cutaquig

  • Patients prioritizing shortest-possible session length. 20% SCIGs deliver the same dose in ~17% less volume, often shaving 30–60 min per session.
  • CIDP maintenance. Use Hizentra (J1559) — the only SCIG with FDA-approved CIDP indication.
  • Hereditary fructose intolerance. Cutaquig is maltose-stabilized and contraindicated — use Cuvitru, Xembify, or Hizentra.
  • Diabetic patients using non-glucose-specific glucose meters. Maltose can interfere with GDH-PQQ glucose monitoring. Cuvitru, Xembify, or Hizentra preferred unless the patient uses a glucose-specific meter.
Document the rationale on the claim and PA. When switching brands or concentrations, payers increasingly require a clinical justification — tolerability event, stabilizer-related contraindication, cost-driven formulary preference, etc. A bare "patient preference" justification will get denied; specifics from the chart will not.

Dosing & unit math FDA label verified May 2026

From the Cutaquig prescribing information (Octapharma, BLA 125598).

Primary humoral immunodeficiency (PI) — adults & children ≥2 yr

  • Conversion from IVIG: initial weekly Cutaquig dose = (previous monthly IVIG dose × 1.37) ÷ 4. Initiate ~1 week after the last IVIG dose.
  • Maintenance range: typically 100–200 mg/kg per week SC, adjusted to maintain therapeutic IgG trough (target individualized; many MACs reference a trough ≥ 500–700 mg/dL).
  • Frequency options: weekly (most common), biweekly (2× weekly dose every 2 weeks), or more frequent than weekly (small-volume daily push).

Worked example — PI patient on 10 g/week (typical adult ~70 kg, ~140 mg/kg)

# Per-infusion (weekly)
Drug mg per dose: 10,000 mg (10 g)
Drug units billed (J1551): 100  # 10,000 ÷ 100 mg/unit
HCPCS: J1551 · Modifier: JZ
Volume infused: ~60.6 mL (10,000 mg ÷ 165 mg/mL) — ~21% larger than a 20% SCIG dose
Vials: 1 × 8 g/48 mL + 1 × 2 g/12 mL (or other combinations)
Admin: 96369 (initial 1 hr, pump set-up + first SC site)
+ 96370 × 1 or 2 (each additional hour, common at 16.5% volume)
+ 96371 (additional pump set-up + new SC site, if 2+ sites used)

# Year-1 totals (52 weekly infusions)
Total drug units billed: 5,200 (52 × 100)
Total drug cost (Q2 2026 ASP+6%): ~$72,420 before sequestration

Vial size to dose mapping

Patient size / weekly doseVial combination (1 of many)Total mgTotal mL (16.5%)Units billed
~50 kg / 5 g weekly1 × 4 g + 1 × 1 g5,000 mg~30.3 mL50 units
~70 kg / 7 g weekly1 × 4 g + 1 × 2 g + 1 × 1 g7,000 mg~42.4 mL70 units
~70 kg / 8 g weekly1 × 8 g8,000 mg~48.5 mL80 units
~70 kg / 10 g weekly1 × 8 g + 1 × 2 g10,000 mg~60.6 mL100 units
~85 kg / 12 g weekly1 × 8 g + 1 × 4 g12,000 mg~72.7 mL120 units
Round to vial size; bill mg actually drawn. Cutaquig's 165 mg/mL concentration means small mg differences map to small mL differences. Choose the vial combination that minimizes waste; bill the mg administered, not the mg ordered. Use JW for any discarded portion of a single-dose vial.

IVIG → SCIG conversion (the 1.37 factor) FDA label verified May 2026

Same conversion math used across the SCIG class — Cutaquig, Hizentra, Cuvitru, Xembify all use the 1.37 coefficient per their FDA labels.

SCIG bioavailability and trough kinetics differ from IV. The Cutaquig label specifies a conversion coefficient of 1.37 applied to the prior monthly IVIG dose, then divided across the weekly SCIG schedule:

# Cutaquig weekly dose calculation
Weekly Cutaquig dose (g) = (Previous monthly IVIG dose (g) × 1.37) ÷ 4

# Examples
20 g monthly IVIG → (20 × 1.37) ÷ 4 = 6.85 g weekly  → round to 7 g
30 g monthly IVIG → (30 × 1.37) ÷ 4 = 10.275 g weekly  → round to 10 g
40 g monthly IVIG → (40 × 1.37) ÷ 4 = 13.7 g weekly  → round to 14 g

# Schedule transitions
Initiate Cutaquig ~1 week after the last IVIG dose
Biweekly equivalent: 2 × the weekly dose every 2 weeks
More-frequent-than-weekly equivalent: weekly dose ÷ N, infused in small volumes N times per week

What changes on the claim during conversion

ElementBefore (IVIG)After (Cutaquig)
HCPCSJ1459 / J1568 / J1569 / J1561 (etc.)J1551
Unit basis500 mg / unit100 mg / unit
Admin CPT96365 (initial) + 96366 (additional hour)96369 + 96370 + 96371
FrequencyEvery 3–4 weeksWeekly (or biweekly / daily)
Site of careOften AIC (POS 49) or HOPD (POS 19/22)Often home (POS 12) after training
AuthorizationIVIG PASubmit new PA for SCIG (most payers)
Submit a new PA at conversion. Even if the same diagnosis is on file, the SCIG product is a separate authorization. Include: prior IVIG regimen, IgG trough on IVIG, conversion calculation, anticipated weekly SCIG dose, training/home-infusion plan, and (if relevant) clinical justification for selecting Cutaquig specifically (cost, tolerability, prior 20% SCIG site reactions, etc.).

NDC & vial reference FDA NDC Directory verified May 2026

Vial sizeVolumeConcentrationNDC family
1 g6 mL165 mg/mL (16.5%)Octapharma labeler 68982-xxx-xx series
2 g12 mL165 mg/mL (16.5%)Octapharma labeler 68982-xxx-xx series
4 g24 mL165 mg/mL (16.5%)Octapharma labeler 68982-xxx-xx series
8 g48 mL165 mg/mL (16.5%)Octapharma labeler 68982-xxx-xx series
Verify the exact 11-digit NDC at billing time. Octapharma updates Cutaquig packaging and NDC sequences periodically; the labeler segment (68982) is stable but the product/package digits can change. Pull the current NDC from the carton or from the FDA NDC Directory before submitting. Pediatric prescriptions are often filled with the smaller vials (1 g, 2 g) to minimize per-vial waste.
All Cutaquig vials are single-dose (single-dose container per CMS terminology). JZ modifier applies on every claim with no waste; JW applies if any portion of a vial is discarded. The 8 g vial is the largest in the family — for adult doses ≥ 10 g, plan vial combinations carefully to minimize waste.
Stabilizer: Cutaquig is maltose-stabilized (not glycine, sucrose, sorbitol, or proline). Two clinical implications: (1) Hereditary fructose intolerance — contraindicated; do not use Cutaquig. (2) Glucose monitoring — maltose can falsely elevate readings on GDH-PQQ-based glucose meters; counsel diabetic patients to use glucose-specific meters during and for 24 hours after infusion.
Phase 2 Code the claim SC pump infusion family (96369/96370/96371) — not IV, not single-shot SC injection.

Administration codes (96369 / 96370 / 96371) CPT verified May 2026

SC pump infusion family. The most common Cutaquig admin error is using IV codes (96365/96366) or single-shot SC injection (96372).

CodeDescriptorWhen to use for Cutaquig
96369 Subcutaneous infusion for therapy or prophylaxis (specify substance or drug); initial, up to 1 hour, including pump set-up and establishment of subcutaneous infusion site(s) Primary code for Cutaquig. Bill once per session. Includes pump priming and the first SC site.
96370 Subcutaneous infusion for therapy or prophylaxis (specify substance or drug); each additional hour (list separately in addition to code for primary procedure) Frequently billed for Cutaquig. Because 16.5% means a larger infusion volume per dose, sessions often run 90–180 min — bill 96370 once or twice per session at 10 g doses.
96371 Subcutaneous infusion for therapy or prophylaxis (specify substance or drug); additional pump set-up with establishment of new subcutaneous infusion site(s) (list separately in addition to code for primary procedure) When a second pump is added or a new SC infusion site is established mid-session. Cutaquig's larger volume often drives 2+ site administration — bill 96371 for each additional pump set-up.
96365 / 96366 Therapeutic IV infusion (initial / each additional hour) NOT appropriate for Cutaquig. These are IV codes; Cutaquig is SC.
96372 Therapeutic SC or IM injection (specify substance or drug) NOT appropriate for Cutaquig. 96372 is a single-shot manual injection. Cutaquig is a pump-driven infusion.
Top admin-code denial pattern: Provider-side billing systems sometimes auto-populate 96365 (IV therapeutic) for any immune globulin claim. For SCIG products (Cutaquig, Hizentra, Cuvitru, Xembify, HyQvia), override to 96369/96370/96371. Audit Cutaquig claims monthly to catch this drift.
Cutaquig-specific 96370/96371 frequency: Because 16.5% Cutaquig sessions run longer and usually use multiple SC sites, 96370 and 96371 are billed more often than for 20% SCIGs. A 10 g Cutaquig session at 2 sites with 90 min total infusion time = 96369 (initial hr + first site) + 96370 (additional 30 min as fraction of next hour) + 96371 (additional pump set-up + 2nd site). Confirm your MAC's add-on billing convention.
Home self-administration: When the patient self-infuses at home, the home-infusion provider bills the per-diem and supplies (S9338 / S9494 / S9559 family or 99601/99602 nursing visits when a nurse is present). The drug J1551 and the 96369/96370/96371 admin codes are typically billed by the infusion provider on the same claim under the medical benefit.

Modifiers CMS verified May 2026

JZ — required on every Cutaquig claim with no waste

Effective July 1, 2023, CMS requires the JZ modifier on every single-dose container claim when no drug is discarded. All Cutaquig vials are single-dose containers. JZ applies on the majority of Cutaquig claims when the dose maps cleanly to vial sizes (1 g, 2 g, 4 g, 8 g).

JW — partial-vial waste

JW reports the discarded portion of a single-dose vial. For Cutaquig, JW applies whenever the dose does not map cleanly to the available vial sizes. Example: a 5 g weekly dose — 1 × 4 g + 1 × 1 g with no waste = JZ. But if a patient receives 9 g and the closest combination is 1 × 8 g + 1 × 2 g (1 g discarded) or 2 × 4 g + 1 × 2 g (1 g discarded), the discarded mg are reported on a separate JW line. One of JZ or JW must be on every J1551 claim line.

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 a Cutaquig training infusion. Pump training visits routinely justify a modifier-25 E/M.

340B modifiers (JG, TB)

For 340B-acquired Cutaquig, follow your MAC's current 340B modifier policy. Cutaquig's lowest-cost SCIG positioning may produce favorable 340B per-gram economics relative to other SCIGs — verify with your 340B contract pharmacy.

ICD-10-CM by indication FY2026 verified May 2026

Cutaquig is FDA-approved for primary humoral immunodeficiency only. Use the most specific code supported by encounter documentation; PI requires IgG-level evidence.

IndicationICD-10 familyDocumentation requirements
Common variable immunodeficiency (CVID)D83.0 – D83.9IgG < 5 g/L (or LCD-specified threshold), poor vaccine response, recurrent infections
Hypogammaglobulinemia (unspecified)D80.1IgG levels, infection history
Selective IgG subclass deficiencyD80.3Subclass quantification + functional antibody response
X-linked agammaglobulinemia (Bruton)D80.0BTK gene confirmation; pediatric onset
Selective IgA deficiencyD80.2Generally NOT an SCIG indication on its own (asymptomatic IgA deficiency is monitored, not treated)
Other immunodeficiency w/ predominantly antibody defectsD80.8 / D80.9Documentation of antibody defect + clinical infections
Combined immunodeficiencyD81.xSCID and variants; usually pediatric
Immunodeficiency w/ other major defectD82.xWiskott-Aldrich (D82.0), DiGeorge (D82.1), etc.
CIDP (G61.81)Not an FDA-approved Cutaquig indicationUse Hizentra (J1559) or HyQvia (J1575) for SCIG CIDP maintenance.
PI documentation is LCD-driven. Most MACs require: (1) IgG level below the LCD threshold, (2) poor specific antibody response to vaccine challenge (pneumococcal, tetanus), and (3) clinical history of recurrent serious infections. PI without IgG-level documentation is a routine denial. UHC, Aetna, Cigna, and BCBS plans typically require these three elements as well.
Cutaquig does NOT cover CIDP. Cutaquig's FDA approval is restricted to primary humoral immunodeficiency. CIDP claims under J1551 will deny on indication. For SCIG CIDP maintenance use Hizentra (J1559, FDA-approved CIDP since March 2018) or HyQvia (J1575, expanded CIDP indication 2024).

Site of care & place of service Verified May 2026

Cutaquig's site-of-care distribution is the inverse of IVIG: home (POS 12) is dominant, with ambulatory infusion (POS 49) and physician office (POS 11) used during the initial training period or for patients unable to self-infuse. Hospital outpatient (POS 19/22) is rarely justified for routine Cutaquig and is the most common site-of-care denial.

SettingPOSClaim formTypical use for Cutaquig
Patient home (self-infusion)12CMS-1500 / 837P (medical benefit) or pharmacy claimDominant setting after training. Most stable Cutaquig patients.
Patient home (RN-administered)12CMS-1500 / 837P with 99601/99602 nursing visitsPatients who cannot self-infuse; intermittent RN visits
Ambulatory infusion suite (AIC)49CMS-1500 / 837PInitial training (1–3 sessions); ongoing if patient can't self-infuse
Physician office11CMS-1500 / 837PTraining; same-day E/M with infusion
Allergy/immunology clinic11 / 49CMS-1500 / 837PFor PI patients managed through immunology clinic infrastructure
Hospital outpatient (on-campus)22UB-04 / 837IRarely justified. Common site-of-care denial.
Hospital outpatient (off-campus PBD)19UB-04 / 837IRarely justified. Common site-of-care denial.
Site-of-care comparison vs IVIG: Where IVIG is steered into ambulatory and home infusion out of hospital outpatient, Cutaquig is steered into home from any other setting. The payer logic: SCIG is designed for home self-administration, so any clinical setting (including AIC) is only justified during training or for patients with documented inability to self-infuse.
Home administration billing: Two pathways — medical benefit (J1551 + 96369/96370/96371 + S9338 per-diem on CMS-1500/837P from home-infusion provider) or pharmacy/specialty (NDC-based pharmacy claim with no J1551 line). Medicare Part B covers Cutaquig plus home-infusion services under the SCIG framework / Home Infusion Therapy Services benefit. Verify per payer.

Claim form field mapping Octapharma OneSource 2026

InformationCMS-1500 boxNotes
NPI17b / 24JRendering provider (or home-infusion provider's NPI)
NDC qualifier + 11-digit NDC + UoM + qty24A shaded areaN4 + 11-digit Cutaquig NDC + ML + total volume in mL (60.6 mL for 10 g)
HCPCS J1551 + JZ (or JW for waste)24D (drug line)One of JZ or JW required on every claim
Drug units24Gmg administered ÷ 100 (e.g., 10,000 mg = 100 units)
CPT 96369 (admin line, primary)24D (admin line)Initial up to 1 hr SC infusion + pump set-up + first SC site
CPT 96370 (admin line, addl hour)24D (additional admin line)Each additional hour beyond 60 min; common at Cutaquig 16.5% volumes
CPT 96371 (addl pump set-up)24D (additional admin line)Additional pump or new SC site, list separately
S9338 (per-diem home infusion)24D (services line)For home-infusion provider claims (medical benefit)
99601 / 99602 (nursing visits)24DWhen RN administers (not patient self-infusion)
ICD-1021D80.x / D81.x / D82.x for PI
PA number23Required by all major payers for SCIG
Phase 3 Get paid PA documentation: IgG levels, vaccine challenge, infection history; conversion math if from IVIG.

Payer LCDs & PA criteria Reviewed May 2026

All major payers PA SCIG. Cutaquig's lowest-cost SCIG positioning may favor it on cost-conscious commercial policies.

PayerPA?Key criteriaCutaquig-specific positioning
UnitedHealthcare
SCIG / Immune Globulin medical policy		 Yes PI: IgG level + vaccine challenge + recurrent infections. Training plan + home-infusion provider authorized at PA. UHC SCIG LCD covers Cutaquig at parity with other SCIGs; Optum cost-of-care steering may favor lowest-cost SCIG on certain plans
Aetna
CPB Immune Globulin		 Yes PI criteria mirror UHC; site-of-care prefers home or AIC for SCIG. Generally allows clinician choice across SCIG class
Cigna
Coverage Policy 1006 (Immune Globulin)		 Yes PI standard criteria; home-infusion benefit detailed in policy SCIG and IVIG covered at parity for stable patients
BCBS plans
Vary by plan		 Yes Generally aligned with FDA label and major commercial peer policies Plan-specific; some BCBS cost-driven formularies designate a single preferred SCIG — verify per plan
Medicare (Part B)
DME MAC SCIG LCD + Home Infusion Therapy Services		 Often (DME) PI well-covered; clinical choice driven by patient/clinician within SCIG class Coverage parity within SCIG class; ASP-driven economics may favor Cutaquig for 340B and some Medicare Advantage plans

PA documentation checklist (PI)

  • IgG level (LCD-specific threshold, often < 5 g/L or < 500 mg/dL)
  • Specific antibody response to vaccine challenge (pneumococcal polysaccharide, tetanus toxoid)
  • Recurrent serious infection history (otitis, sinusitis, pneumonia, etc.) with treatment dates
  • Conversion calculation if transitioning from IVIG (1.37 factor)
  • Home-infusion training plan + designated provider (commercial)
  • Brand-specific justification if payer requires preferred SCIG (cost, tolerability event on prior 20% SCIG, stabilizer-driven contraindication, etc.)

Medicare reimbursement CMS Q2 2026 (live)

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

Q2 2026 payment snapshot — J1551

Effective April 1 – June 30, 2026 · 1 unit = 100 mg

ASP + 6%
$13.927
per 100 mg unit (~$0.139/mg)
10 g weekly dose
$1,392.70
100 units × ASP+6%
Per gram
$139.27
10 units (1 g) × ASP+6%
Annualized cost: 10 g weekly × 52 weeks = ~$72,420/year (Medicare ASP+6%) for a typical 70 kg PI patient at ~140 mg/kg/week. Larger patients scale proportionally. After ~2% sequestration: ~$70,970/year actual paid.

Per-gram comparison — SCIG class (Q2 2026)

  • Cutaquig (J1551, 16.5%): ~$139/g — lowest-cost major SCIG
  • Hizentra (J1559, 20%): ~$145/g
  • Xembify (J1558, 20%): ~$154/g range
  • Cuvitru (J1555, 20%): ~$176/g range
  • HyQvia (J1575, IG + hyaluronidase): higher per-gram (different therapeutic positioning)
  • Gamunex-C SC (J1561, 10%): bills under IVIG 500 mg/unit basis

Cutaquig's per-gram ASP is currently the lowest in the SCIG class. The differential is not large in absolute dollars but compounds over a year of weekly therapy: a 10 g/week patient on Cutaquig vs Cuvitru is ~$19,000/year cheaper to the payer at Q2 2026 pricing. Cost-driven payer formulary decisions and 340B economics increasingly favor Cutaquig within the SCIG class.

Per-gram comparison — SCIG vs IVIG

SCIG products generally run higher per-gram than IVIG products due to concentration manufacturing premium and self-administration convenience. Total cost of care comparison favors SCIG once chair time, nursing time, and AE costs are included — which is why payers actively prefer SCIG for stable chronic PI patients despite the per-gram drug premium.

Coverage

No NCD specific to Cutaquig. Coverage falls under MAC LCDs for SCIG (immune globulin subcutaneous) and the Home Infusion Therapy Services benefit. All MACs cover J1551 for FDA-approved on-label primary humoral immunodeficiency with appropriate ICD-10 and clinical documentation.

Patient assistance — Octapharma OneSource Octapharma verified May 2026

  • Octapharma OneSource: 1-888-429-4535 — benefits investigation, prior authorization assistance, appeal support, training resources for both Cutaquig and Octagam
  • Cutaquig Co-Pay Assistance Program: commercial copay support for eligible commercially-insured patients (excludes Medicare, Medicaid, federal program patients)
  • Octapharma Patient Assistance: free product for uninsured / underinsured patients meeting income requirements
  • Independent foundations for Medicare patients: PAN Foundation (immunodeficiency funds), HealthWell Foundation, Patient Advocate Foundation — verify open funds quarterly
  • IDF (Immune Deficiency Foundation): primaryimmune.org — patient education, advocacy, resources
  • Web: octapharma.com · cutaquig.com
Need to model what a specific Cutaquig patient will actually pay after copay assistance, deductible, coinsurance, and OOP max? Run a CareCost Estimate — J1551 pre-loaded.

SCIG brand interchangeability Verified May 2026

SCIG products are NOT interchangeable for billing. Each brand has its own HCPCS, NDC, ASP, concentration, and stabilizer. Match the code to the product actually infused.

HCPCSBrandMfrConcentrationStabilizerUnit basisFDA-approved indications
J1551 Cutaquig (this page) Octapharma 16.5% liquid SC (only non-20% SCIG) Maltose 100 mg PI (adult + ped ≥2)
J1559 Hizentra CSL Behring 20% liquid SC L-proline 100 mg PI (adult + ped ≥2); CIDP maintenance (adult, only SCIG with CIDP indication since 2018)
J1555 Cuvitru Takeda 20% liquid SC Glycine 100 mg PI (adult + ped ≥2)
J1558 Xembify Grifols 20% liquid SC Glycine 100 mg PI (adult + ped ≥2)
J1575 HyQvia Takeda 10% IG + recombinant hyaluronidase (facilitated SC) Glycine 100 mg IG (per HCPCS) PI; CIDP maintenance (adult, expanded 2024) — monthly dosing possible
J1561 Gamunex-C Grifols / Kedrion 10% liquid (IV or SC use) Glycine 500 mg (IV basis applies even when given SC) PI (IV/SC), ITP (IV), CIDP (IV)
IVIG companion class (500 mg unit basis, IV admin codes 96365/96366):
J1568 Octagam (Octapharma sister product) Octapharma 5% / 10% liquid IV Maltose 500 mg PI; chronic ITP; dermatomyositis (10%)
J1459 Privigen CSL Behring 10% liquid IV L-proline 500 mg PI, ITP, CIDP
J1569 Gammagard Liquid Takeda 10% liquid IV Glycine 500 mg PI, MMN
Three brand-related billing patterns to avoid:
  • Wrong code, right route: billing J1551 (Cutaquig) for a patient who actually received Hizentra (J1559), Cuvitru (J1555), or Xembify (J1558) is a denial trigger and a compliance issue. ASP differences create a $/unit delta auditors will catch.
  • Wrong unit basis when crossing routes: applying the IVIG 500 mg/unit basis to Cutaquig (or vice versa) under-reports or over-reports the dose by 5×. The most common crossover error is on Gamunex-C (J1561) when given SC — it still uses the 500 mg/unit basis because the HCPCS is the IV code.
  • Right code, payer-mandated different brand: some payers contract preferentially with specific SCIG brands. Cost-conscious commercial plans may now favor Cutaquig as the lowest-cost SCIG; other plans may steer to Hizentra or Cuvitru. Verify the payer's preferred SCIG brand on every PA; do not assume continuity across payers.

When clinical brand justification is needed

  • Diabetes / non-glucose-specific glucose meters: avoid maltose-stabilized SCIG (Cutaquig) due to interference; switch to glycine-stabilized (Cuvitru, Xembify) or proline-stabilized (Hizentra).
  • Hereditary fructose intolerance: Cutaquig contraindicated; use Cuvitru, Xembify, or Hizentra.
  • Hyperprolinemia: avoid proline-stabilized products (Hizentra); prefer glycine (Cuvitru, Xembify) or maltose (Cutaquig).
  • Tolerability history on 20% SCIG: switching from 20% to 16.5% Cutaquig is a documented strategy for patients with persistent local site reactions on Hizentra/Cuvitru/Xembify.
  • Monthly dosing preference: consider HyQvia (J1575) which uses recombinant hyaluronidase to enable larger-volume monthly SC infusions.
  • CIDP indication: Cutaquig is not FDA-approved for CIDP; use Hizentra (J1559) or HyQvia (J1575).
Phase 4 Fix problems Unit math, IV-vs-SC admin code confusion, and missing PA documentation are the top three.

Common denials & how to fix them

Denial reasonCommon causeFix
Unit math wrong (under by 5x)IVIG 500 mg/unit basis applied to J1551Recalculate: J1551 = 100 mg/unit. 10 g = 100 units. Resubmit corrected.
Unit math wrong (over by 100x)1 mg/unit (per-mg) basis applied; 10,000 units submitted for 10 gRecalculate: J1551 = 100 mg/unit. 10 g = 100 units. Resubmit corrected.
Wrong admin code (96365)IV therapeutic code billed instead of SC pump infusionResubmit with 96369 (initial) + 96370 (each addl hour) + 96371 (addl pump set-up if used).
Wrong admin code (96372)Single-shot SC injection code billed instead of pump infusionResubmit with 96369 + 96370 + 96371. 96372 is for one-time SC injections, not pump-driven SCIG.
96370/96371 underbilledCutaquig 16.5% volumes drive longer sessions / multiple sites — only 96369 billedAdd 96370 for sessions >60 min and 96371 for each additional pump set-up / new SC site. Document time and site count in chart.
JZ/JW missingSingle-dose container claim without modifierResubmit with JZ if no waste, JW with discarded units if partial vial.
PI dx without IgG documentationD80.x submitted without IgG level, vaccine challenge, or infection historySubmit complete LCD-required documentation and request retroactive PA.
CIDP indication on Cutaquig claimG61.81 submitted under J1551 (Cutaquig is PI-only)Switch to Hizentra (J1559) or HyQvia (J1575) for CIDP maintenance — both have FDA-approved CIDP indications.
Site of care (HOPD)Cutaquig billed from POS 19/22 outside of training periodMove to home (POS 12), AIC (POS 49), or office (POS 11). Document medical necessity if HOPD truly required.
Per-diem without drug or vice versaS9338 billed without J1551 (or J1551 without S-code on home claim)Both lines required on home-infusion claims. Resubmit complete claim.
Wrong SCIG brand for payer formularyCutaquig billed when payer requires Hizentra / Cuvitru / XembifyVerify formulary; switch product or submit non-formulary exception with clinical justification (cost, tolerability, stabilizer).
No new PA at IVIG → SCIG conversionOld IVIG PA used for new Cutaquig claimSubmit fresh PA with conversion calculation, training plan, and home-infusion provider designation.
Maltose interference / glucose monitoring not addressedDiabetic patient on Cutaquig + non-glucose-specific meter; clinical event triggers payer reviewDocument patient education on glucose-specific monitoring; consider switch to glycine- or proline-stabilized SCIG if recurrent.

Frequently asked questions

What is the HCPCS code for Cutaquig and what is the unit basis?

Cutaquig is billed under HCPCS J1551 — "Inj cutaquig 100 mg." Each 100 mg of IgG equals one billable unit. This is NOT the IVIG 500 mg/unit basis used by J1459, J1568, J1569, J1561, etc., and it is NOT a per-mg basis. A 10 g (10,000 mg) weekly dose bills as 100 units of J1551.

How is Cutaquig different from Hizentra, Cuvitru, and Xembify?

Cutaquig is the only major SCIG at 16.5% concentration (165 mg/mL). Hizentra (J1559), Cuvitru (J1555), and Xembify (J1558) are all 20% (200 mg/mL). The lower concentration means a 17% larger infusion volume per dose, which can mean more SC sites per session, longer per-session time, or biweekly → weekly schedule conversion. Some patients prefer 16.5% for tolerability (lower viscosity, gentler distension, often better at sites with prior reactions); others prefer 20% for shorter sessions. Cutaquig is also currently the lowest-cost SCIG by Medicare ASP+6%.

What administration CPT codes do I use for Cutaquig?

Use 96369 (subcutaneous infusion, initial up to 1 hr, including pump set-up and first SC site) for the primary code, plus 96370 (each additional hour) for sessions running >60 min, and 96371 (additional pump set-up + new SC site) when a second pump or site is initiated. Cutaquig's 16.5% concentration means a larger infusion volume per dose vs 20% SCIGs — sessions often run 90–180 minutes and frequently use multiple SC sites, so 96370 and 96371 are commonly billed alongside 96369. Do NOT bill 96365/96366 (those are IV) and do NOT bill 96372 (single-shot SC injection, not a pump infusion).

What is the Medicare reimbursement for J1551?

For Q2 2026, the Medicare Part B payment limit for J1551 is $13.927 per 100 mg unit (ASP + 6%), or roughly $139 per gram and $0.139 per mg. A 10 g weekly dose bills as 100 units and reimburses at $1,392.70 per infusion. Annualized at 52 weekly infusions: roughly $72,420/year for a 10 g/week patient. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%. Cutaquig is currently the lowest-cost major SCIG by Medicare ASP+6%.

How do I convert a monthly IVIG dose to a weekly Cutaquig dose?

Per the FDA Cutaquig label and the broader SCIG class: weekly Cutaquig dose = (previous monthly IVIG dose × 1.37) ÷ 4. The 1.37 factor accounts for differences in bioavailability and trough kinetics between IV and SC routes. Example: 30 g IVIG monthly converts to (30 × 1.37) ÷ 4 = 10.275 g weekly Cutaquig, rounded to 10 g per week. Initiate Cutaquig roughly 1 week after the last IVIG dose. See the conversion section.

Why might a clinician choose Cutaquig over a 20% SCIG?

Three common reasons: (1) Cost — Cutaquig is the lowest-cost SCIG by Medicare ASP+6%, so cost-conscious payer policies and 340B economics may favor it. (2) Tolerability profile — the 16.5% concentration produces a less viscous solution with gentler local site reactions for some patients; switching from 20% to 16.5% is a documented strategy for patients with persistent local site reactions. (3) Stabilizer — Cutaquig is maltose-stabilized, preferred over proline (Hizentra) in patients with hyperprolinemia. Cutaquig is not appropriate for hereditary fructose intolerance (contraindicated) or for patients dependent on non-glucose-specific glucose meters.

Is Cutaquig billed as a medical benefit or a pharmacy/DME benefit when self-administered at home?

Both pathways exist. Medical benefit (Part B / commercial medical): bill J1551 + 96369/96370/96371 + S9338 per-diem from the home-infusion provider on a CMS-1500/837P. Pharmacy/specialty: NDC-based pharmacy claim with no J1551 line. Medicare Part B typically covers Cutaquig plus home-infusion services for primary immunodeficiency under the SCIG framework / Home Infusion Therapy Services benefit. Verify per payer — UHC, Aetna, BCBS, and Medicare DME MACs all have product-specific home-infusion policies.

What ICD-10 codes support Cutaquig coverage?

For primary humoral immunodeficiency: D80.x (immunodeficiency w/ predominantly antibody defects, e.g., D80.0 X-linked, D80.1 hypogamma, D80.3 IgG subclass, D83.x CVID family), D81.x (combined immunodeficiencies), D82.x (immunodeficiency with other major defects). Cutaquig does NOT have an FDA-approved CIDP indication — for CIDP maintenance SCIG, use Hizentra (J1559) or HyQvia (J1575).

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

Source documents

  1. FDA — Cutaquig (Immune Globulin Subcutaneous, Human, 16.5% Liquid)
    FDA-approved product page; PI indication, BLA 125598
  2. Cutaquig HCP & patient site — Octapharma
    Coding, billing, training, and home-infusion resources for Cutaquig
  3. Octapharma — Cutaquig product page (US)
    PI dosing, vial sizes, conversion math, stabilizer profile
  4. CMS — Medicare Part B Drug ASP Pricing File
    Q2 2026 quarterly file, effective April 1 – June 30, 2026 — J1551 = $13.927/100 mg unit
  5. CMS — Home Infusion Therapy Services (21st Century Cures Act framework)
  6. AAAAI — Primary Immunodeficiency Practice Parameters
    Diagnostic + treatment guidance referenced by major payer SCIG LCDs
  7. Immune Deficiency Foundation (IDF)
    Patient-facing PI education, advocacy, and IG therapy resources
  8. UnitedHealthcare — Immune Globulin / SCIG medical policy
    UHC SCIG LCD criteria; SCIG-preference language for stable PI
  9. Aetna — Immune Globulin Clinical Policy Bulletin
  10. FDA National Drug Code Directory

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, Cigna, BCBS)Semi-annualManual review against published payer SCIG LCDs and CPBs.
HCPCS / CPT / modifier rulesAnnualReviewed against CMS HCPCS quarterly files and AMA CPT releases.
NDC, dosing, FDA labelEvent-drivenTied to manufacturer document version + FDA label revision date.
SCIG brand interchangeability matrixSemi-annualCross-checked against each brand's current FDA label and ASP file entry.
Concentration differentiator narrativeAnnualReviewed against AAAAI practice parameters + clinical literature on SCIG concentration tolerability.

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 (J1551 = $13.927/100 mg unit, lowest-cost SCIG). Manufacturer source: Octapharma OneSource 2026. FDA label verified May 2026 (Cutaquig BLA 125598, PI indication only). Includes 16.5% vs 20% concentration differentiator analysis, IVIG-to-SCIG conversion math (1.37 factor), full SCIG brand interchangeability matrix, and cross-links to sister Octapharma product Octagam (J1568 IVIG).

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. Indications, concentrations, and stabilizers are verified against the current FDA label for each SCIG brand. We do not paraphrase from billing-software vendor blogs.

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