J0801 Acthar Gel Billing: Units, Dosing & ICD-10 (Q4 2026)

Phase 1 Identify what you're billing Get the unit basis right before anything else — and keep J0802 off the claim.

Unit basis — 1 J0801 unit = 40 USP units CMS verified May 2026

The single most error-prone field in Acthar Gel billing. Get this wrong and every claim denies.

HCPCS J0801 is "Injection, Acthar Gel, up to 40 units" — meaning one billable unit of J0801 covers up to 40 USP units of corticotropin. The prescribing units (USP units of corticotropin) and the billing units (J0801 line-item units) are not 1:1. This is unusual in the HCPCS code set and is the leading cause of Acthar denials.

Do not bill J0801 in USP units. If the patient receives 80 USP units, do NOT bill J0801 × 80 units — that would be billing 3,200 USP units (80 × 40). The correct claim is J0801 × 2 units (each unit = up to 40 USP units). Most payer claim systems will reject the over-units submission, but partial-pay denials and provider-side audit risk are real.

Unit conversion table

USP units administered	J0801 line-item units	Notes
40 USP units	1	"up to 40 units" = one unit
75 USP units	2	First unit covers 40; the remaining 35 is a second "up to 40" unit
80 USP units	2	Common adult MS/sarcoidosis dose
100 USP units	3	Two full units plus a partial third (20 of 40)
120 USP units	3	Common upper-bound MS exacerbation dose; equals the MUE of 3 per day
160 USP units	4	Higher-dose adjunctive scenarios — exceeds the MUE of 3; expect a medical-necessity review

Partial units: "up to 40 units" means a partial increment is a whole unit (75 USP = 2 units, because the remaining 35 is a second "up to 40"). Some payers ask for the conversion math in claim notes for non-standard doses; document it.

J0801 units — and why J0802 is not an Acthar code CMS ASP crosswalk verified Sep 2026

One J0801 unit per 40 USP units (or part). J0802 is CMS's code for Purified Cortrophin Gel (ANI), the other repository corticotropin product.

Code	Descriptor	When to use
`J0801`	"Injection, Acthar Gel, up to 40 units"	The only code for Acthar Gel. Bill ⌈USP units ÷ 40⌉ units: 20, 30 or 40 USP units = 1 unit; 80 = 2; 120 = 3.
`J0802`	"Injection, corticotropin (ANI), up to 40 units"	Purified Cortrophin Gel (ANI Pharmaceuticals) — a different product with its own NDCs and payment limit. Never on an Acthar claim; an Acthar NDC under J0802 is a mismatch the crosswalk edit rejects.

Worked examples

# Example 1 — MS exacerbation, 80 USP units SC daily Per-dose billing: J0801 \times 2 Per-dose Medicare ASP+6%: ~$7,768.53 Admin: CPT 96372 # Example 2 — MS exacerbation, 120 USP units SC daily Per-dose billing: J0801 \times 3 Per-dose Medicare ASP+6%: ~$11,652.80 Admin: CPT 96372 # Example 3 — Infantile spasms, 75 USP units/m² BID, BSA 0.4 m² = 30 USP units BID Per-dose billing: J0801 \times 1 Per-dose Medicare ASP+6%: ~$3,884.27 Twice-daily \times 14 days = 28 doses billed

Common error: Billing J0802 as an "additional 40 units" add-on for Acthar. J0802 is CMS's code for Purified Cortrophin Gel (ANI) — the NDC-HCPCS crosswalk lists only ANI's NDCs under it — so an Acthar NDC on a J0802 line is a product mismatch. Doses above 40 USP units are J0801 × N (the MUE is 3 units a day, i.e. 120 USP units).

Dosing & unit math FDA label verified May 2026

From the Mallinckrodt-recommended dosing in the current FDA prescribing information.

Route

Subcutaneous (SC) or intramuscular (IM) — both are FDA-labeled routes
Never IV — intravenous administration is contraindicated and can cause severe hypersensitivity reactions
Most outpatient scenarios use SC route for self/caregiver administration

Vial

5 mL multi-dose vial @ 80 USP units/mL = 400 USP units per vial
Single 5 mL vial provides ~10 doses of 40 USP units, ~5 doses of 80 USP units, or ~3-4 doses of 120 USP units
Multi-dose vial — track per-dose draws against vial total for waste documentation (see Modifiers)

Premedication

Not required. Acthar Gel is a porcine-derived ACTH analog and does not require infusion-style premedication. Standard injection-site care applies.

Multi-indication dosing matrix Mallinckrodt label verified May 2026

Acthar Gel has 10+ FDA indications with dramatically different dosing patterns. Match the dose to the documented diagnosis on every claim.

Indication	Dose	Route	Schedule	Per-dose J0801 units
MS acute exacerbations (adult)	80–120 USP units	IM/SC	Daily × 2–3 weeks, then taper	J0801 × 2–3
Infantile spasms (West syndrome)	75 USP units/m²	IM/SC	BID × 2 weeks, then taper over 2 weeks	J0801 × 1 (× 2 if the BSA-based dose is >40)
Nephrotic syndrome (induction)	80 USP units	IM/SC	Daily × 1 week	J0801 × 2
Nephrotic syndrome (maintenance)	80 USP units	IM/SC	Every 2–3 days	J0801 × 2
Rheumatic disorders (RA, AS, PsA)	40–80 USP units	IM/SC	Every 24–72 hours	J0801 × 1 (× 2 if 80)
Collagen diseases (SLE, dermatomyositis, polymyositis)	40–80 USP units	IM/SC	Every 24–72 hours	J0801 × 1 (× 2 if 80)
Symptomatic sarcoidosis	80 USP units	IM/SC	Every 48–72 hours	J0801 × 2
Severe psoriasis / erythema multiforme	40–80 USP units	IM/SC	Every 24–72 hours	J0801 × 1 (× 2 if 80)
Refractory severe asthma / atopic dermatitis	40–80 USP units	IM/SC	Per response, typically q24-72h	J0801 × 1 (× 2 if 80)
Severe ophthalmic inflammation	40–80 USP units	IM/SC	Per response, typically q24-72h	J0801 × 1 (× 2 if 80)

Infantile spasms (West syndrome) is the only clear gold-standard indication. Per American Academy of Neurology / Child Neurology Society 2022 guideline, ACTH (or vigabatrin) is first-line for new-onset infantile spasms. For all other Acthar indications, payers expect documentation of failed/contraindicated standard corticosteroid therapy first.

BSA-based pediatric dose calculation: Infantile spasms dosing is 75 USP units/m² BID. A 0.3 m² infant receives ~22 USP units BID (J0801 × 1 only); a 0.5 m² child receives ~38 USP units BID (still J0801 × 1 only); a 0.6 m² child receives 45 USP units BID (J0801 × 2). Document BSA calculation in claim notes.

NDC reference FDA NDC Directory verified May 2026

NDC (10/11-digit)	Package	Use
`63004-7731-01` / `63004-77310-01`	5 mL multi-dose vial — 80 USP units/mL (400 USP units total)	Standard commercial package; one vial provides ~10 doses of 40 USP units

Multi-dose vial means waste tracking matters. Unlike single-dose vials where the JZ modifier blanket-applies, Acthar's 5 mL multi-dose vial requires per-draw documentation. Report discarded/expired contents separately if the vial is not fully used within the in-use beyond-use date.

Phase 2 Code the claim SC/IM injection coding (96372). Never IV infusion codes.

Administration codes CPT verified May 2026

Acthar Gel is SC/IM only. Use 96372 — do NOT use IV infusion codes (96365/96366) or pump infusion codes (96370/96371).

Code	Description	When to use
`96372`	Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular	Primary code for Acthar Gel. Single SC or IM injection. One unit per administration.
`96365` / `96366`	Therapeutic IV infusion	NOT appropriate. Acthar Gel is contraindicated for IV administration; severe hypersensitivity risk if given IV.
`96370` / `96371`	SC infusion via pump (non-chemo)	NOT appropriate. Acthar is a single SC/IM injection, not a pump infusion. Use 96372 only.
`99211–99215`	E/M codes	Use modifier 25 when significant separately identifiable E/M is performed same day as injection.

Never IV. Per FDA label, Acthar Gel must NOT be administered intravenously. IV administration can cause severe hypersensitivity reactions. Confirm SC/IM route on every order; reject any order written "IV" before administering.

Modifiers CMS verified May 2026

JZ — multi-dose vial considerations

CMS's July 2023 single-dose container policy mandates JZ on claims with no waste from a single-dose container. Acthar Gel ships in a 5 mL multi-dose vial, so the strict JZ/JW single-dose policy does not apply in the same way as it does to single-dose biologics. However, many payer systems still expect a modifier on Acthar claims for audit clarity. Document per-draw amounts and the in-use beyond-use-date for the vial.

JW — discarded multi-dose vial contents

If the multi-dose vial expires before all 400 USP units are used (28-day in-use BUD typical for repository corticotropin), report discarded units on a separate JW line per MAC policy. Track per-vial utilization carefully — high per-unit cost makes any discarded contents materially expensive.

MAC variation: Modifier policy for Acthar's multi-dose vial varies by MAC. Novitas/FCSO may handle differently than Noridian/Palmetto. Verify your MAC's published policy before the first Acthar claim each year.

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 injection. Routine pre-injection clinical assessment is bundled.

340B modifiers (JG, TB)

For 340B-acquired Acthar Gel, follow your MAC's current 340B modifier policy. Acthar's high price makes 340B participation status particularly impactful for hospital outpatient claims.

Check the unit math. Billing units come from the HCPCS descriptor — not the vial size, and not the milligrams administered. The infusion billing units calculator converts a dose for J0801 into billable units, resolves the vial combination, and separates the administered amount from any discarded amount — which is what determines whether the drug line carries JW or JZ.

ICD-10-CM by indication group FY2026 verified May 2026

10+ FDA-approved indications. Use the most specific code supported by encounter documentation.

Indication	ICD-10 family	Notes
Multiple sclerosis (acute exacerbation)	`G35.x`	Adult; document acute exacerbation in encounter note. The bare G35 parent is not billable — use a subcode (G35.A, G35.B0–B2, G35.C0–C2, G35.D)
Infantile spasms (West syndrome)	`G40.821` (intractable, with status) / `G40.822` (intractable, without)	Pediatric <2 yr; gold-standard indication; document EEG findings
Nephrotic syndrome (idiopathic)	`N04.x`	4th character per histologic pattern (minimal change, FSGS, MN, etc.)
Nephrotic syndrome (lupus-related)	`M32.14` + `N08`	SLE with nephritis
Rheumatoid arthritis	`M05.x` / `M06.x`	Adjunctive only; document standard therapy failure
Ankylosing spondylitis	`M45.x`	Adjunctive only
Psoriatic arthritis	`L40.5x`	Severe disease; adjunctive
Systemic lupus erythematosus (SLE)	`M32.x`	Adjunctive in collagen disease group
Dermatomyositis / polymyositis	`M33.x` / `M33.20`	Adjunctive in collagen disease group
Severe psoriasis	`L40.x`	Severe; adjunctive
Severe erythema multiforme	`L51.x`	Adjunctive in dermatologic group
Refractory severe asthma	`J45.5x`	Adjunctive in allergic states
Severe atopic dermatitis	`L20.x`	Adjunctive in allergic states
Symptomatic sarcoidosis	`D86.0–D86.9`	Site-specific 4th character
Severe ophthalmic inflammation	`H10.x` / `H20.x` / `H30.x`	Severe acute or chronic allergic/inflammatory
Edematous states (proteinuria)	`R60.x` + nephrotic ICD-10	Used for diuresis induction in nephrotic syndrome

Indication-specific PA criteria. Most payers require ICD-10 + prior corticosteroid therapy history + clinical justification for Acthar specifically. The ICD-10 alone is not sufficient for approval — see the aggressive payer PA section below.

Site of care & place of service Verified May 2026

Most Acthar Gel administration is outpatient: physician office, specialty pharmacy with home self-/ caregiver-administration, or pediatric neurology clinic for infantile spasms. Hospital outpatient billing of Acthar is rare and typically draws additional UM scrutiny.

Setting	POS	Claim form	Notes
Physician office (rheumatology, neurology, pulm, derm, etc.)	11	CMS-1500 / 837P	Most common — J0801 + 96372
Pediatric neurology clinic (infantile spasms)	11	CMS-1500 / 837P	BID dosing for first 2 weeks; coordinate caregiver training
Specialty pharmacy + home administration	12	Specialty pharmacy bills drug; provider may bill teaching/E&M	Common for chronic adjunctive use; CuraScript / Accredo / others
Hospital outpatient (HOPD)	22 / 19	UB-04 / 837I	Rare; expect additional payer scrutiny
Inpatient (rare)	21	UB-04 / 837I	Bundled into DRG; not separately billable

Claim form field mapping Mallinckrodt 2025

Multi-dose vial + the 40-USP-unit billing unit + the J0802 look-alike code = three layers of error potential.

Information	CMS-1500 box	Notes
NPI	17b	Rendering provider
NDC qualifier + 11-digit NDC + UoM + qty	24A shaded area	N4 + carton NDC + ML + total volume drawn (e.g., 0.5 mL for 40 USP units, 1 mL for 80 USP units)
HCPCS J0801 (drug line)	24D	⌈USP units ÷ 40⌉ units per administration (80 USP = 2)
CPT 96372 (admin line)	24D	Therapeutic SC/IM injection
ICD-10	21	Indication-specific (see ICD-10 table)
PA number	23	Required by virtually all major payers
Modifier (JZ/JW per multi-dose policy)	24D	Verify MAC-specific multi-dose vial modifier guidance

Phase 3 Get paid Aggressive PA scrutiny is the single biggest barrier to Acthar reimbursement.

Aggressive payer PA scrutiny Reviewed May 2026

Acthar Gel is one of the most-scrutinized drugs in US billing. Pricing controversy + broad indication list = layered PA criteria.

Pricing context. Acthar Gel pricing increased approximately 100,000% between 2001 and 2018 — from roughly $40 per vial to over $40,000 per vial — following Questcor's 2001 acquisition of the product and Mallinckrodt's 2014 acquisition of Questcor. The DOJ's 2020 settlement with Mallinckrodt and ongoing payer-side litigation have made Acthar one of the most-scrutinized Part B drugs in the catalog.

Per-payer PA snapshot

Payer	PA?	Step therapy	Indication-specific criteria
UnitedHealthcare Acthar-specific medical policy	Yes — aggressive	Generic prednisone or methylprednisolone failure required for most non-infantile-spasms indications	For MS: IV methylprednisolone failure documented. For infantile spasms: neurology consult + EEG/NCS findings.
Aetna CPB (Acthar-specific)	Yes — aggressive	Required for adjunctive indications (RA, PsA, lupus, sarcoidosis, etc.)	Aetna lists infantile spasms as the only "preferred" Acthar indication. All others require detailed corticosteroid failure or contraindication documentation.
Cigna Coverage Position	Yes — aggressive	Generic corticosteroid failure required for most indications	Cigna requires documented inadequate response or intolerance to at least 2 weeks of optimized corticosteroid therapy.
BCBS plans	Yes	Plan-specific; generally aligned with national specialty drug PA frameworks	Most plans require corticosteroid trial documentation; some plans cover infantile spasms with neurology consult only.
Medicare Part B (FFS)	No PA at MAC level	None at MAC level	Pays per ASP+6% methodology; on-label coverage. MA plans commonly impose commercial-style PA on top.
Medicaid	Yes — state-specific	State-specific; often required	State PDLs typically nonpreferred status; PA criteria highly variable.

Documentation checklist for PA submission

Specific FDA indication with ICD-10 code and clinical narrative
Prior corticosteroid history: drug name, dose, duration, response (or contraindication rationale)
For MS exacerbations: IV methylprednisolone trial details (typically 1 g daily × 3-5 days), response or contraindication
For infantile spasms: neurology consult note, EEG findings (hypsarrhythmia), age, prior therapy
For nephrotic syndrome: renal biopsy if available, prior immunosuppressive therapy, urine protein levels
For rheumatic / collagen disease: rheumatology consult, prior DMARD/biologic history, disease activity measures
Planned dose, route, and duration per FDA label
Provider attestation that no formulary corticosteroid alternative is appropriate

Alternative corticosteroid cost comparison Reviewed May 2026

Payers explicitly compare Acthar to generic prednisone and methylprednisolone. The cost differential is 1,000 to 10,000-fold.

Drug	Per-dose cost (typical)	Per-course cost (typical)	Notes
Acthar Gel (J0801 × 2, 80 USP units)	~$7,769 (Medicare ASP+6%)	~$40,000–$80,000 (2-3 week course)	Repository corticotropin, SC/IM
Generic prednisone (oral, 60 mg)	$0.10–$1.00	$10–$50 (2-3 week taper)	First-line for most non-infantile-spasms indications
Methylprednisolone IV (Solu-Medrol, 1 g)	$15–$50	$45–$250 (3-5 day pulse)	Standard for MS acute exacerbation; tried before Acthar in MS PA
Vigabatrin (alternative to Acthar for infantile spasms)	~$50–$200/day	~$5,000–$15,000 (initial course)	Listed alongside ACTH as first-line for infantile spasms per AAN/ChNS

# Cost differential — MS exacerbation (3-week course) Acthar 80 USP units IM/SC daily \times 21 days: ~ $172,000 IV methylprednisolone 1 g daily \times 5 days + oral taper: ~ $200-$500 Differential: ~340\times to 850\times more for Acthar

This is the single biggest reason for Acthar denials. Payers will compare your clinical justification against the cost differential. For MS exacerbations, IV methylprednisolone failure documentation is the standard prerequisite. For infantile spasms, the AAN/ChNS guideline position protects ACTH first-line status. For all other indications, expect tight scrutiny of the prior corticosteroid trial.

Medicare reimbursement CMS Q4 2026 (live)

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

Q4 2026 payment snapshot — J0801

Effective October 1 – December 31, 2026 · Based on 2Q26 ASP submissions

ASP + 6% per billing unit

$3,884.267

per 40 USP unit (~$97.11/USP unit)

80 USP unit dose

$7,768.53

J0801 × 2

120 USP unit dose

$11,652.80

J0801 × 3

Per-course estimate — MS exacerbation: 80–120 USP units IM/SC daily × 14–21 days = ~$115,000–$258,000 drug cost (Medicare ASP+6%) before sequestration. After ~2% sequestration, actual paid is ~ASP + 4.3%.

Per-course estimate — infantile spasms (West syndrome): 75 USP units/m² BID × 14 days, then 2-week taper. For a 0.4 m² infant: 30 USP units BID × 28 doses (induction) + taper doses = ~$115,000–$170,000 total course (Medicare ASP+6%).

Coverage

Acthar Gel is covered under Medicare Part B as a physician-administered injectable. No NCD specific to repository corticotropin. MAC LCDs vary; Medicare Advantage plans commonly impose commercial-style PA criteria on top of FFS coverage. Pediatric infantile spasms cases may also intersect with Medicaid coverage where the patient is dually eligible.

Code history

J0801 — "Injection, Acthar Gel, up to 40 units" — current permanent code
J0802 — "Injection, corticotropin (ANI), up to 40 units" — Purified Cortrophin Gel, not Acthar
Note: before the product-specific J0801/J0802 codes, repository corticotropin was billed under J0800; verify code effective dates if reviewing historical claims.

Patient assistance — Acthar Patient Support Mallinckrodt verified May 2026

Acthar Patient Support: 1-888-435-2284 — benefits investigation, prior authorization assistance, appeal support
Mallinckrodt Patient Assistance Program: free or reduced-cost product for uninsured / underinsured patients meeting income requirements
Acthar Co-pay Card: commercial copay support; eligible commercially-insured patients (excludes Medicare, Medicaid, federal program patients per anti-kickback rules); first dose may be available at $0 copay
Foundations: for Medicare patients, refer to PAN Foundation, HealthWell, Patient Advocate Foundation. Verify open disease-state funds quarterly — rare-disease and rheumatic disease funds are most relevant.
Web: acthar.com · mallinckrodt.com

Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance, and OOP max? Run a CareCost Estimate — J0801 pre-loaded.

Phase 4 Fix problems Unit conversion, the J0802 look-alike code, PA documentation, and prior corticosteroid history are the top denial categories.

Common denials & how to fix them

Denial reason	Common cause	Fix
Excess units billed	J0801 billed in USP units (e.g., 80 units instead of 1)	Resubmit with J0801 × 2 for an 80 USP unit dose. Each J0801 unit = up to 40 USP units.
J0802 billed for Acthar	Product / code mismatch: J0802 is Purified Cortrophin Gel (ANI); the Acthar NDC does not crosswalk to it	Resubmit the whole dose as J0801 × N units. J0802 belongs only on a Cortrophin Gel claim.
Prior corticosteroid trial not documented	PA submitted without standard steroid failure history	Document prednisone or methylprednisolone trial (drug, dose, duration, response or contraindication). For MS, document IV methylprednisolone failure.
Wrong admin code (96365)	IV infusion code billed for SC/IM injection	Resubmit with 96372. Acthar is SC/IM only; never IV.
Indication not on FDA label	Off-label use without compendium support	Acthar's broad on-label list rarely requires compendium use; verify ICD-10 maps to one of the 10+ FDA indications.
PA criteria not met (specific indication)	e.g., MS without methylprednisolone failure documentation	Submit complete PA with indication-specific clinical evidence per the payer's medical policy.
Multi-dose vial waste reporting missing	Vial expired with unused contents; JW not reported	Track per-vial in-use BUD; report discarded units on JW line per MAC policy.
Live vaccine concern flagged	Patient received live vaccine while on Acthar	Vaccinations (especially live) are contraindicated during Acthar therapy; document timing in claim notes.

Frequently asked questions

What is the HCPCS code for Acthar Gel?

Acthar Gel (repository corticotropin injection) is billed under HCPCS J0801 — "Injection, Acthar Gel, up to 40 units." This is one of the most error-prone unit definitions in the HCPCS code set: 1 billable unit of J0801 = 40 USP units of corticotropin. So a 40 USP unit dose is billed as 1 unit of J0801; an 80 USP unit dose is billed as 2 units of J0801 (each unit is "up to 40 units").

What is the difference between J0801 and J0802?

J0801 is Acthar Gel: one unit per 40 USP units (or part of 40). J0802 is a different product — "Injection, corticotropin (ANI), up to 40 units," ANI Pharmaceuticals' Purified Cortrophin Gel — with its own NDCs and payment limit; it is not an "additional 40 units" add-on for Acthar. For an 80 USP unit Acthar dose bill J0801 × 2; for 120 USP units, J0801 × 3.

How many units do I bill for an 80 USP unit Acthar Gel dose?

For an 80 USP unit SC or IM dose, bill J0801 × 2 units. Do not bill J0801 × 80 (USP units are not billing units), and do not add a J0802 line — that code is Purified Cortrophin Gel, and an Acthar NDC on it is a product mismatch.

What administration CPT do I use for Acthar Gel?

CPT 96372 — "Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular." Acthar Gel is SC or IM only. Do NOT bill 96365/96366 (IV infusion codes) or 96370/96371 (SC pump infusion codes). Acthar is contraindicated for IV administration.

What is the Medicare reimbursement for Acthar Gel?

For Q4 2026, the Medicare Part B payment limit for J0801 is $3,884.267 per billable unit (= 40 USP units), or roughly $97.11 per USP unit (ASP + 6%). An 80 USP unit dose reimburses at approximately $7,768.53 per administration; a 120 USP unit dose at approximately $11,652.80.

Why are payers so aggressive on Acthar prior auth?

Acthar Gel pricing increased ~100,000% from 2001 to 2018 (roughly $40 to over $40,000 per vial), making it one of the most-scrutinized drugs in US billing. UnitedHealthcare, Aetna, and Cigna all maintain Acthar-specific PA criteria requiring detailed indication-specific clinical justification AND documentation of standard corticosteroid (prednisone, methylprednisolone) failure or contraindication. Generic prednisone is roughly 1,000-10,000 times cheaper per course of therapy.

What are the FDA-approved indications for Acthar Gel?

Broad list: (1) acute MS exacerbations; (2) infantile spasms / West syndrome (gold standard per AAN/ChNS); (3) idiopathic or lupus nephrotic syndrome; (4) rheumatic disorders (RA, AS, PsA); (5) collagen diseases (SLE, dermatomyositis, polymyositis); (6) dermatologic disease (severe psoriasis, erythema multiforme); (7) refractory severe asthma / atopic dermatitis; (8) severe ophthalmic inflammation; (9) symptomatic sarcoidosis; (10) edematous states.

Is Acthar Gel given subcutaneously or intramuscularly?

Either — both SC and IM are FDA-labeled. Acthar must NEVER be given intravenously (contraindicated; severe hypersensitivity risk). Most outpatient scenarios use SC for self/caregiver administration. Both routes use CPT 96372 for administration billing.

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

Source documents

Acthar Gel — Official Mallinckrodt site
Manufacturer Patient Support program, dosing, indication overview
DailyMed — H.P. Acthar Gel Prescribing Information
FDA-approved label, repository corticotropin injection (Mallinckrodt ARD LLC); most recent revision February 2024
CMS — Medicare Part B Drug ASP Pricing File
Q4 2026 quarterly file, effective October 1 – December 31, 2026
SEER CanMED — HCPCS J0801 reference
SEER CanMED — HCPCS J0801 reference
AAN/ChNS — Infantile Spasms / West syndrome guideline
Establishes ACTH (and vigabatrin) as first-line therapy
AAN MS guidelines — acute relapse management
IV methylprednisolone is standard first-line for acute MS exacerbations
ACR — Rheumatic disease practice guidelines
KDIGO — Glomerular Diseases (nephrotic syndrome) guideline
UnitedHealthcare — Acthar Gel medical policy
Aetna CPB — Repository corticotropin (Acthar Gel)
Cigna — Acthar Gel coverage position
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

Element	Cadence	How it's refreshed
Medicare ASP pricing (J0801)	Quarterly	Auto-bound to CareCost ASP layer; updates on CMS file release.
Payer policies (UHC, Aetna, Cigna, BCBS)	Semi-annual	Manual review against published payer Acthar-specific medical policy documents.
HCPCS / CPT / modifier rules + multi-dose vial guidance	Annual	Reviewed against CMS HCPCS quarterly files, AMA CPT releases, and MAC LCD updates.
NDC, dosing, FDA label, indication list	Event-driven	Tied to manufacturer document version + FDA label revision date.

Reviewer

Reviewed by Erin Rose, CareCost Estimate founder. Figures come from FDA labeling, CMS quarterly ASP files, and payer policy documents, cited inline. See our methodology and editorial policy. Found an error? Report it.

Change log

Sep 20, 2026 — Correction. This page had described J0802 as an Acthar "each additional 40 units" add-on and told readers never to bill J0801 × 2. CMS's October 2026 ASP NDC-HCPCS crosswalk assigns J0802 to ANI's Purified Cortrophin Gel only; Acthar doses above 40 USP units are J0801 × N (MUE 3/day). Worked examples, the unit table, the claim-form map and the FAQ were rewritten; the 80-unit figure ($7,768.53) is unchanged in value.
May 23, 2026 — SME audit pass. Updated DailyMed link to setid 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 (rev Feb 2024); freshness ribbon updated. Confirmed no boxed warning, indication list aligned to current label. J0801/J0802 codes, dosing, and ASP unchanged.
May 2, 2026 — Initial publication. ASP data: Q2 2026. Manufacturer source: Mallinckrodt 2025. FDA label: most recent revision. 10+ FDA-approved indications. J0801/J0802 dual-code structure documented. Payer-side aggressive PA scrutiny + generic prednisone alternative cost comparison.

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.

Acthar Gel (repository corticotropin) — HCPCS J0801

Instant Answer — the 5 things you need to bill J0801

Unit basis — 1 J0801 unit = 40 USP units CMS verified May 2026

Unit conversion table

J0801 units — and why J0802 is not an Acthar code CMS ASP crosswalk verified Sep 2026

Worked examples

Dosing & unit math FDA label verified May 2026

Route

Vial

Premedication

Multi-indication dosing matrix Mallinckrodt label verified May 2026

NDC reference FDA NDC Directory verified May 2026

Administration codes CPT verified May 2026

Modifiers CMS verified May 2026

JZ — multi-dose vial considerations

JW — discarded multi-dose vial contents

Modifier 25 — same-day E/M

340B modifiers (JG, TB)

ICD-10-CM by indication group FY2026 verified May 2026

Site of care & place of service Verified May 2026

Claim form field mapping Mallinckrodt 2025

Aggressive payer PA scrutiny Reviewed May 2026

Per-payer PA snapshot

Documentation checklist for PA submission

Alternative corticosteroid cost comparison Reviewed May 2026

Medicare reimbursement CMS Q4 2026 (live)

Q4 2026 payment snapshot — J0801

Coverage

Code history

Patient assistance — Acthar Patient Support Mallinckrodt verified May 2026

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Acthar Gel?

What is the difference between J0801 and J0802?

How many units do I bill for an 80 USP unit Acthar Gel dose?

What administration CPT do I use for Acthar Gel?

What is the Medicare reimbursement for Acthar Gel?

Why are payers so aggressive on Acthar prior auth?

What are the FDA-approved indications for Acthar Gel?

Is Acthar Gel given subcutaneously or intramuscularly?

Source documents

About this page

Refresh cadence

Reviewer

Change log

Methodology

Stop calculating Acthar Gel copays by hand.