HCPCS
J0801
1 unit = 40 USP units
Phase 1
Identify what you're billing
Get the unit basis and the J0801/J0802 split right before anything else.
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/J0802 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 × 1 unit + J0802 × 1 unit, totaling 80 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 | J0802 line-item units | Notes |
|---|---|---|---|
| 40 USP units | 1 | 0 | J0801 only; "up to 40" |
| 75 USP units | 1 | 1 | J0801 covers first 40; J0802 covers remaining 35 (still "each additional 40") |
| 80 USP units | 1 | 1 | Common adult MS/sarcoidosis dose |
| 100 USP units | 1 | 2 | J0801 covers first 40; J0802 × 2 covers remaining 60 |
| 120 USP units | 1 | 2 | Common upper-bound MS exacerbation dose |
| 160 USP units | 1 | 3 | Higher-dose adjunctive scenarios |
Alternate payer interpretation: Some payers expect J0802 line-item units to round up
based on partial 40-unit increments (e.g., 75 USP = J0801 + J0802 × 1 because the remaining 35 fits
within "each additional 40"). Others enforce strict 40-unit billing. Verify per-payer for non-standard
doses; document conversion math in claim notes.
J0801 vs J0802 — which codes when CMS HCPCS verified May 2026
J0801 is always the base; J0802 stacks on for doses exceeding 40 USP units in a single administration.
| Code | Descriptor | When to use |
|---|---|---|
J0801 |
"Injection, Acthar Gel, up to 40 units" | Always required for any Acthar Gel administration. Bill 1 unit per administered dose, regardless of whether the dose is 20, 30, or 40 USP units. |
J0802 |
"Injection, Acthar Gel, each additional 40 units" | Required when dose exceeds 40 USP units in a single administration. Bill the appropriate number of additional 40-unit increments (or partial increments per payer policy). |
Worked examples
# Example 1 — MS exacerbation, 80 USP units SC daily
Per-dose billing: J0801 × 1 + J0802 × 1
Per-dose Medicare ASP+6%: ~$8,188.52
Admin: CPT 96372
# Example 2 — MS exacerbation, 120 USP units SC daily
Per-dose billing: J0801 × 1 + J0802 × 2
Per-dose Medicare ASP+6%: ~$12,282.78
Admin: CPT 96372
# Example 3 — Infantile spasms, 75 USP units/m² BID, BSA 0.4 m² = 30 USP units BID
Per-dose billing: J0801 × 1 + J0802 × 0
Per-dose Medicare ASP+6%: ~$4,094.26
Twice-daily × 14 days = 28 doses billed
Per-dose billing: J0801 × 1 + J0802 × 1
Per-dose Medicare ASP+6%: ~$8,188.52
Admin: CPT 96372
# Example 2 — MS exacerbation, 120 USP units SC daily
Per-dose billing: J0801 × 1 + J0802 × 2
Per-dose Medicare ASP+6%: ~$12,282.78
Admin: CPT 96372
# Example 3 — Infantile spasms, 75 USP units/m² BID, BSA 0.4 m² = 30 USP units BID
Per-dose billing: J0801 × 1 + J0802 × 0
Per-dose Medicare ASP+6%: ~$4,094.26
Twice-daily × 14 days = 28 doses billed
Common error: Billing J0801 × 2 (or more) units for a single administration
instead of J0801 × 1 + J0802 × N. The HCPCS descriptor for J0801 is singular ("up to 40
units") — only one J0801 unit is billable per administration. The add-on stacks on J0802.
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/J0802 |
|---|---|---|---|---|
| MS acute exacerbations (adult) | 80–120 USP units | IM/SC | Daily × 2–3 weeks, then taper | J0801 × 1 + J0802 × 1–2 |
| Infantile spasms (West syndrome) | 75 USP units/m² | IM/SC | BID × 2 weeks, then taper over 2 weeks | J0801 × 1 (+ J0802 if BSA-based dose >40) |
| Nephrotic syndrome (induction) | 80 USP units | IM/SC | Daily × 1 week | J0801 × 1 + J0802 × 1 |
| Nephrotic syndrome (maintenance) | 80 USP units | IM/SC | Every 2–3 days | J0801 × 1 + J0802 × 1 |
| Rheumatic disorders (RA, AS, PsA) | 40–80 USP units | IM/SC | Every 24–72 hours | J0801 × 1 (+ J0802 × 1 if 80) |
| Collagen diseases (SLE, dermatomyositis, polymyositis) | 40–80 USP units | IM/SC | Every 24–72 hours | J0801 × 1 (+ J0802 × 1 if 80) |
| Symptomatic sarcoidosis | 80 USP units | IM/SC | Every 48–72 hours | J0801 × 1 + J0802 × 1 |
| Severe psoriasis / erythema multiforme | 40–80 USP units | IM/SC | Every 24–72 hours | J0801 × 1 (+ J0802 × 1 if 80) |
| Refractory severe asthma / atopic dermatitis | 40–80 USP units | IM/SC | Per response, typically q24-72h | J0801 × 1 (+ J0802 × 1 if 80) |
| Severe ophthalmic inflammation | 40–80 USP units | IM/SC | Per response, typically q24-72h | J0801 × 1 (+ J0802 × 1 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 × 1 + J0802 × 1). 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.
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 | Adult; document acute exacerbation in encounter note |
| 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/J0802 + 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 + dual-code (J0801/J0802) + USP unit conversion = 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, base) | 24D | Always 1 unit per administration |
| HCPCS J0802 (drug line, add-on) | 24D | Only when dose >40 USP units; appropriate number of additional 40-unit increments |
| 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/J0802, 80 USP units) | ~$8,189 (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 × 21 days: ~$172,000
IV methylprednisolone 1 g daily × 5 days + oral taper: ~$200–$500
Differential: ~340× to 850× more for Acthar
Acthar 80 USP units IM/SC daily × 21 days: ~$172,000
IV methylprednisolone 1 g daily × 5 days + oral taper: ~$200–$500
Differential: ~340× to 850× 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 Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J0801
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6% per billing unit
$4,094.259
per 40 USP unit (~$102.36/USP unit)
80 USP unit dose
$8,188.52
J0801 × 1 + J0802 × 1
120 USP unit dose
$12,282.78
J0801 × 1 + J0802 × 2
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, Acthar Gel, each additional 40 units" — current permanent code
- Note: prior to current J0801/J0802 split, repository corticotropin used different code structures; 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/J0802 pre-loaded.
Phase 4
Fix problems
Unit conversion, J0801/J0802 stacking, 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 × 1 + J0802 × 1 for an 80 USP unit dose. Each J0801 unit = 40 USP units. |
| J0802 billed without J0801 | Add-on code without base code | J0801 must always be on the claim alongside J0802 for the same administration. |
| 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 1 unit of J0801 plus 1 unit
of J0802 ("each additional 40 units").
What is the difference between J0801 and J0802?
J0801 covers Acthar Gel administrations of up to 40 USP units (one billable unit). J0802 covers each additional 40 USP units beyond the first 40 in a single administration. For an 80 USP unit dose: bill J0801 × 1 + J0802 × 1. For a 120 USP unit dose: bill J0801 × 1 + J0802 × 2. Both codes are billed together for any administration exceeding 40 USP units; J0801 is always the base.
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 × 1 unit AND J0802 ×
1 unit. Do not bill J0801 × 2 units — that is a common error that triggers payer denial.
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 Q2 2026, the Medicare Part B payment limit for J0801 is $4,094.259 per billable unit (= 40 USP units), or roughly $102.36 per USP unit (ASP + 6%). An 80 USP unit dose reimburses at approximately $8,188.52 per administration; a 120 USP unit dose at approximately $12,282.78.
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
- DailyMed — H.P. Acthar Gel Prescribing Information
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — HCPCS J0801 reference
- SEER CanMED — HCPCS J0802 reference
- AAN/ChNS — Infantile Spasms / West syndrome guideline
- AAN MS guidelines — acute relapse management
- 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, J0802) | 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
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: 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.