Acthar Gel (corticotropin) — HCPCS J0801 / J0802
CareCost Estimate · Billing Cheat Sheet
Mallinckrodt Pharmaceuticals
5 mL multi-dose vial (80 USP units/mL) · ~10 doses per vial
SC or IM (NEVER IV)
Reviewed: May 3, 2026
ASP: Q3 2026
HCPCS
J0801
1 unit = 40 USP units
Typical Dose
80 USP
= 2 units (J0801) for most rheumatic indications
Modifier
JZ / JW
Multi-dose vial → track waste
Admin CPT
96372
SC therapeutic (NEVER IV)
Medicare ASP+6%
$4,133.449
/40 USP unit · ~$8,189/80-USP dose
UNIT BASIS TRAP: J0801 = 40 USP units per billing unit. Dose ≤40 USP = J0801 (1 unit). Dose >40 USP = J0801 (1 unit) + J0802 each addl 40 USP units. 80 USP dose = J0801 + J0802 = 2 billing units. NEVER administer IV.
Codes & NDC
| HCPCS | J0801 — first 40 USP units (1 unit) per administration |
|---|
| HCPCS+ | J0802 — each additional 40 USP units beyond first 40 |
|---|
| NDC | 63004-8710-01 5 mL multi-dose vial (80 USP/mL = 400 total USP/vial) |
|---|
| Storage | Refrigerate 2-8°C; protect from light |
|---|
| Mfr | Mallinckrodt Pharmaceuticals (formerly Questcor) |
|---|
Multi-indication dosing
| Indication | Dose | Schedule |
|---|
| MS acute exacerbation | 80-120 USP IM/SC | daily × 2-3 wks (taper) |
| Infantile spasms | 75 USP/m² IM/SC BID | 2 wks then taper 2 wks |
| Nephrotic syndrome | 80 USP IM/SC daily | Wk 1, then q2-3d |
| Rheumatic disorders | 40-80 USP IM/SC | q24-72h |
| Symptomatic sarcoidosis | 80 USP IM/SC | q48-72h |
Admin & modifiers
| Code | When |
|---|
96372 | Therapeutic SC/IM, non-chemo |
| NEVER IV — can cause severe hypersensitivity / anaphylaxis |
| Multi-dose vial — track per-dose draws; JW for unused remainder if entire vial discarded |
ICD-10 (by indication)
| Code | For |
|---|
G35 | Multiple sclerosis |
G40.821 | Infantile spasms (West syndrome) |
N04.x | Nephrotic syndrome |
M05.x / M06.x | RA |
M32.x | SLE |
D86.x | Sarcoidosis |
Generic prednisone alternative
| Drug | Per-dose cost | Course cost |
|---|
| Acthar Gel (J0801) | ~$8,189 (80 USP) | ~$40,000-80,000+ |
| Generic prednisone | $0.10-1.00 | $10-50 |
1,000-10,000× cost differential. Payers require documented standard corticosteroid failure (or contraindication) before approving Acthar.
Payer PA (AGGRESSIVE scrutiny)
| Payer | PA | Requirements |
|---|
| UnitedHealthcare | Yes (strict) | Detailed clinical justification + standard steroid failure docs |
| Aetna | Yes (strict) | Same + sometimes denies most adult rheum/derm indications |
| Cigna | Yes | Indication-specific criteria; infantile spasms favored |
| Medicare LCD | Yes | Specialty consult + step from prednisone (except infantile spasms) |
Historical pricing controversy: Acthar price increased ~100,000% from 2001-2018 ($40 → $40,000+). Payers are now extremely cautious.
Medicare reimbursement (Q3 2026)
| Field | Value |
|---|
| ASP + 6% (J0801) | $4,094.26 / 40 USP |
| 40 USP dose | $4,094.26 (1 unit J0801) |
| 80 USP dose | $8,188.52 (J0801 + J0802) |
| 120 USP dose | $12,282.78 (J0801 + 2× J0802) |
| 2-week MS course (80 USP × 14) | ~$114,639 |
Site of care
| Setting | POS | Notes |
|---|
| Physician office | 11 | SC/IM admin |
| Patient home | 12 | After training (SC self-admin) |
| Specialty pharmacy | — | Mail-order to home |
Patient assistance
- Phone: 1-888-435-2284 (Acthar Patient Support)
- Acthar Co-pay Card (commercial $0 first dose)
- Mallinckrodt Patient Assistance Program (free for uninsured)
Reviewed by Erin Rose, CareCost Estimate founder. Every figure triangulated against FDA labeling, CMS ASP files & payer policy — see
methodology.