CurrentUnitedHealthcarePolicy CS2025D0037Y

Repository Corticotropin Injections

Medical benefit drug policy governing coverage and medical necessity criteria for repository corticotropin injections (Acthar Gel and Purified Cortrophin Gel) for UnitedHealthcare members; identifies approved and unproven indications and applicable procedural/diagnosis codes.

Policy Summary

PayerUnitedHealthcare

PolicyRepository Corticotropin Injections

Policy CodePolicy CS2025D0037Y

Change TypeNo material change

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and submit diagnosis plus caregiver attestation (with explanation) and use FDA-consistent dosing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2proven indications listed

≤1 moauth length (infantile spasms)

≤3 moauth length (opsoclonus-myoclonus)

J0801,J0802HCPCS codes

multipleunproven conditions

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Coverage and Medical Necessity Criteria

Infantile spasms (Initial therapy)

Covered when ALL of the following are met:

Infantile spasms (West Syndrome): Diagnosis of infantile spasms (West Syndrome); patient is less than 2 years old; provider attestation that the caregiver is not able to be trained or is physically unable to administer the drug, with submitted explanation; dosing is in accordance with FDA‑approved labeling; authorizations will be for no longer than 1 month.

Opsoclonus-myoclonus syndrome (Initial therapy)

Covered when ALL of the following are met:

Opsoclonus-myoclonus syndrome (Kinsbourne Syndrome): Diagnosis of opsoclonus-myoclonus syndrome (Kinsbourne Syndrome); provider attestation that the caregiver is not able to be trained or is physically unable to administer the drug, with submitted explanation; dosing is in accordance with FDA‑approved labeling; authorizations will be for no longer than 3 months.

Acthar Gel and Purified Cortrophin Gel are not medically necessary for the treatment of acute exacerbations of multiple sclerosis. These products are considered unproven and not medically necessary for any indication outside the policy’s proven uses (infantile spasms and opsoclonus-myoclonus syndrome).

Use of Acthar Gel and Purified Cortrophin Gel is considered unproven and not medically necessary for the following categories and conditions: allergic states (e.g., serum sickness, atopic dermatitis); collagen diseases (e.g., systemic lupus erythematosus, systemic dermatomyositis/polymyositis); dermatologic diseases (e.g., severe erythema multiforme, Stevens–Johnson syndrome, severe psoriasis); edematous states to induce diuresis or remission of proteinuria in nephrotic syndrome without uremia; ophthalmic diseases (e.g., severe acute or chronic inflammatory eye processes including keratitis, iritis, iridocyclitis, posterior uveitis, choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation); respiratory diseases (symptomatic sarcoidosis); and rheumatic disorders (e.g., psoriatic arthritis, rheumatoid arthritis including juvenile rheumatoid arthritis, ankylosing spondylitis, acute gouty arthritis).

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Acthar Gel and Purified Cortrophin Gel. Authorizations are time-limited: infantile spasms (West syndrome) — authorizations will be for no longer than 1 month; opsoclonus-myoclonus syndrome (Kinsbourne syndrome) — authorizations will be for no longer than 3 months.

Affected HCPCS: J0801, J0802
Infantile spasms — max authorization: 1 month
Opsoclonus-myoclonus syndrome — max authorization: 3 months

Note

Clinical sequencing note

ACTH (repository corticotropin injections) is identified as a first-line treatment for infantile spasms alongside vigabatrin. Timely assessment of treatment efficacy is required: assess response at 2 weeks for ACTH (followed by taper if effective). Longer trials (>2 weeks for ACTH; >3 months for vigabatrin) are discouraged because they are unlikely to be effective and may increase risk of serious adverse events. Effective treatment should produce cessation of spasms and resolution of hypsarrhythmia on EEG.

ACTH and vigabatrin are the only drugs with proven effectiveness to suppress clinical spasms and abolish hypsarrhythmic EEG in randomized trials
Timely reassessment: 2 weeks for ACTH with taper if responding
Document both clinical cessation of spasms and EEG resolution (hypsarrhythmia)

Documentation Required

Required documentation

Provider must submit the following documentation with the prior authorization request: diagnosis (infantile spasms or opsoclonus-myoclonus), patient age demonstrating <2 years for infantile spasms when applicable, dosing consistent with FDA-approved labeling, and a provider attestation explaining why the caregiver cannot be trained or is physically unable to administer the drug (attestation must include an explanation).

Include applicable diagnosis code(s) from policy (e.g., G40.821–G40.824 for epileptic/infantile spasms; G25.3/G25.9/H55.89 as applicable)
Attach plan for timely efficacy assessment (EEG and clinical evaluation at ~2 weeks for ACTH)
Specify requested HCPCS (J0801 or J0802) and dosing per FDA labeling

Denial Risk

Denial triggers

Requests that do not meet the proven indications or lack required documentation will be denied. Examples that may trigger denial include: indication outside the covered diagnoses list, missing provider attestation regarding caregiver administration, dosing not consistent with FDA labeling, missing age criteria for infantile spasms, or failure to document planned timely assessment of treatment efficacy.

Denial triggers include: non‑covered indication (see unproven list), missing caregiver attestation, absent or insufficient documentation of diagnosis, age criteria not met for infantile spasms, or no plan for 2‑week efficacy reassessment for ACTH

Definitions and Condition Summaries

Repository corticotropin — key definitions

AgentRepository corticotropin (an adrenocorticotropic hormone [ACTH] analogue)

Primary mechanismStimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and weak androgens; binds melanocortin receptors

Physiologic effectsProlonged high‑dose use induces adrenal cortical hyperplasia and hypertrophy with continuous high corticosteroid output

Signaling pathwayTrophic effects on adrenal cortex mediated by cyclic adenosine monophosphate (cyclic AMP)

Relation to endogenous ACTHFunctions similarly to endogenous ACTH but also binds melanocortin receptors; release of endogenous ACTH is regulated by hypothalamic input and negative corticosteroid feedback

Infantile spasms (West Syndrome) — definition and policy notes

DefinitionA seizure disorder of infancy (Infantile spasms, i.e., West Syndrome)

Age/diagnosis threshold for coveragePatient must be less than 2 years old

Provider attestation requirementProvider must attest that the caregiver cannot be trained or is physically unable to administer the drug and submit an explanation

Dosing requirementDosing must be in accordance with FDA‑approved labeling

Authorization lengthAuthorizations will be for no longer than 1 month for initial therapy

G25.3	Myoclonus
G25.9	Extrapyramidal and movement disorder, unspecified.
G40.821	Epileptic spasms, not intractable, with status epilepticus.
G40.822	Epileptic spasms, not intractable, without status epilepticus.
G40.823	Epileptic spasms, intractable, with status epilepticus.
G40.824	Epileptic spasms, intractable, without status epilepticus.
H55.89	Other irregular eye movements

OpenPayer

Repository Corticotropin Injections

Coverage and Medical Necessity Criteria

Billing and Coding

Provider Requirements, Prior Authorization, and Documentation

Background and Rationale

Definitions and Condition Summaries

J0801	Injection, corticotropin (acthar gel), up to 40 units.
J0802	Injection, corticotropin (ani), up to 40 units