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: Q2 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%

$4,094.259

/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 (Q2 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)

Pending SME review. Verify against current Mallinckrodt label, payer-specific PA criteria (especially UHC/Aetna), and CMS ASP file at billing time.

Sources: FDA label, CMS Q2 2026 ASP, AAN MS guidelines, AAN/ChNS infantile spasms guideline, ACR + KDIGO guidelines, Mallinckrodt Acthar Patient Support, UHC/Aetna Acthar PA criteria. carecostestimate.com/drugs/acthar-gel