Sierra Health and Life corticotropin Coverage Update

Coverage Criteria

Infantile Spasms (Initial therapy)

Covered when ALL of the following are met:

Infantile spasms criteria: 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, and provider must submit an explanation; Dosing is in accordance with FDA‑approved labeling; Authorizations will be for no longer than 1 month.

References randomized trials and consensus guidance supporting ACTH as an effective option; assessment at two weeks recommended.

Opsoclonus‑Myoclonus Syndrome (Initial therapy)

Covered when ALL of the following are met:

OMS criteria: 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, and provider must submit an explanation; Authorizations will be for no longer than 3 months.

Clinical studies show biochemical and clinical responses to ACTH; combination therapy may be more effective than monotherapy.

Multiple Sclerosis (Acute exacerbations)

MS exacerbation: Acthar Gel and Purified Cortrophin Gel are not medically necessary for treatment of acute exacerbations of multiple sclerosis for members where medical necessity rules apply; some non‑medical necessity plans may cover Acthar for MS exacerbations.

Cochrane and guideline evidence favors corticosteroids; ACTH less commonly used.

Acthar Gel and Purified Cortrophin Gel are considered unproven and not medically necessary for treatment of multiple rheumatic, collagen, dermatologic, allergic, ophthalmic, respiratory, and edematous conditions and for any indication outside the proven indications. Examples listed in the policy include: allergic states (serum sickness, atopic dermatitis); collagen diseases (systemic lupus erythematosus, systemic dermatomyositis/polymyositis); dermatologic diseases (severe erythema multiforme, Stevens‑Johnson syndrome, severe psoriasis); edematous states (to induce diuresis or remission of proteinuria in idiopathic or lupus nephrotic syndrome without uremia); ophthalmic diseases (severe acute and chronic allergic/inflammatory processes such as keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation); respiratory diseases (symptomatic sarcoidosis); and rheumatic disorders (psoriatic arthritis, rheumatoid arthritis including juvenile rheumatoid arthritis, ankylosing spondylitis, and acute gouty arthritis).

This Medical Benefit Drug Policy is provided for informational purposes and does not constitute medical advice. Coverage decisions are governed by the member‑specific benefit plan document and any applicable federal or state mandates; in the event of a conflict, the member‑specific benefit plan governs. Providers must verify member benefits and plan terms before requesting authorization, as terms may differ from the standard policy and UnitedHealthcare may modify policies or apply additional tools in administration.

Use of Acthar Gel and Purified Cortrophin Gel is not medically necessary for the conditions listed as unproven in the policy. Representative examples include rheumatic and collagen diseases (psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis; ankylosing spondylitis; systemic lupus erythematosus; systemic dermatomyositis/polymyositis), dermatologic disorders (severe erythema multiforme; Stevens‑Johnson syndrome; severe psoriasis), allergic conditions (serum sickness; atopic dermatitis), ophthalmic inflammatory diseases (keratitis; iritis; iridocyclitis; posterior uveitis; choroiditis; optic neuritis; chorioretinitis; anterior segment inflammation), respiratory disease (symptomatic sarcoidosis), and edematous states related to nephrotic syndrome without uremia. Coverage is limited to proven indications described elsewhere in this policy.

Coding and Diagnosis

Covered HCPCS/J CodesHCPCS

J0801	Injection, corticotropin (Acthar Gel), up to 40 units.
J0802	Injection, corticotropin (ANI), up to 40 units

Diagnosis (ICD-10) Codes referencedICD-10

G25.3	Myoclonus.
G25.9	Extrapyramidal and movement disorder, unspecified.
G35.A	Relapsing-remitting multiple sclerosis (only for those members without medical necessity).
G35.B0	Primary progressive multiple sclerosis, unspecified (only for those members without medical necessity).
G35.B1	Active primary progressive multiple sclerosis (only for those members without medical necessity).
G35.B2	Non-active primary progressive multiple sclerosis (only for those members without medical necessity).
G35.C0	Secondary progressive multiple sclerosis, unspecified (only for those members without medical necessity).
G35.C1	Active secondary progressive multiple sclerosis (only for those members without medical necessity).
G35.C2	Non-active secondary progressive multiple sclerosis (only for those members without medical necessity).
G35.D	Multiple sclerosis, unspecified (only for those members without medical necessity).

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Applicable ICD-10 Codes (edits)ICD-10

G35.A	Added applicable ICD-10 diagnosis code (specific multiple sclerosis subcode)
G35.B0	Added applicable ICD-10 diagnosis code (specific multiple sclerosis subcode)
G35.B1	Added applicable ICD-10 diagnosis code (specific multiple sclerosis subcode)
G35.B2	Added applicable ICD-10 diagnosis code (specific multiple sclerosis subcode)
G35.C0	Added applicable ICD-10 diagnosis code (specific multiple sclerosis subcode)
G35.C1	Added applicable ICD-10 diagnosis code (specific multiple sclerosis subcode)
G35.C2	Added applicable ICD-10 diagnosis code (specific multiple sclerosis subcode)
G35.D	Added applicable ICD-10 diagnosis code (specific multiple sclerosis subcode)
G35	Removed general G35 code from applicable diagnosis list

inv-10: Age limit for infantile spasms — Patient is less than 2 years old

Age limitPatient is less than 2 years old

Authorization durationAuthorizations will be for no longer than 1 month

Indication contextApplies to infantile spasms (West Syndrome) when other criteria met

Provider Actions & Requirements

Prior Authorization

Prior Authorization and Policy Use

Prior authorization is required for repository corticotropin injections (e.g., Acthar Gel, Purified Cortrophin Gel). Authorizations must follow this Medical Benefit Drug Policy and the member-specific benefit plan; in case of conflict, the member-specific benefit plan governs. UnitedHealthcare may modify policies and rely on third-party tools (e.g., InterQual) when administering benefits.

Prior authorization required for repository corticotropin injections (HCPCS J0801, J0802).
Authorization limits: infantile spasms — up to 1 month; opsoclonus-myoclonus syndrome — up to 3 months.
Check member-specific benefit plan and applicable federal/state mandates before submitting authorization.
Policy is informational and may be modified; member-specific plan governs in case of conflict.

Billing Rule

Initial Therapy Criteria

Initial therapy (Infantile spasms)

Initial therapy for infantile spasms: Diagnosis of infantile spasms; 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 per FDA approved labeling; Authorization duration limited to no longer than 1 month.

Randomized trials and ISWG consensus support ACTH or vigabatrin as first‑line; assess response at two weeks.

Continuation and Authorization Duration

Authorization duration limits

Authorization duration limits: Authorizations for infantile spasms will be for no longer than 1 month; authorizations for opsoclonus‑myoclonus syndrome will be for no longer than 3 months.

Step Therapy Guidance

Step	Clinical guidance / requirement
1	ACTH (repository corticotropin) and vigabatrin are considered first‑line treatment options for infantile spasms (West syndrome).
2	Timely assessment of treatment response is recommended: assess at two weeks for ACTH; if no response by two weeks, promptly modify therapy. (Consensus guidance: ISWG).

Definitions

inv-21: Infantile spasms (West Syndrome) — A seizure disorder in infants for which Acthar Gel and Purified Cortrophin Gel are indicated; policy limits treatment to patients younger...

DefinitionInfantile spasms (West Syndrome) — a seizure disorder in infants for which Acthar Gel and Purified Cortrophin Gel are indicated

Age restrictionTreatment limited to patients less than 2 years old

Authorization limitAuthorizations will be for no longer than 1 month when criteria are met

Required documentationProvider attestation that caregiver cannot be trained or is physically unable to administer the drug; provider must submit explanation

inv-22: Opsoclonus‑myoclonus syndrome (OMS, Kinsbourne Syndrome) — A neuroimmunologic disorder for which Acthar Gel and Purified Cortrophin Gel may be authorized for up to three months when provider attes...

Definition

Background

Repository corticotropin (ACTH) is an adrenocorticotropic hormone analogue that stimulates the adrenal cortex to secrete cortisol and other steroids and also interacts with melanocortin receptors. Prolonged administration can cause adrenal cortical hypertrophy and increased cortisol output; these effects are mediated in part by cyclic AMP. The policy references product labeling and clinical literature to support the pharmacologic description and clinical use considerations for Acthar Gel and Purified Cortrophin Gel.

Revision History

2025-10-01codes_updatedLatest

Updated applicable ICD-10 diagnosis codes: added G35.A, G35.B0, G35.B1, G35.B2, G35.C0, G35.C1, G35.C2, and G35.D; removed the general G35 code; archived previous policy version 2025D0037T.

OpenPayer

Repository corticotropin injections (Acthar Gel; Purified Cortrophin Gel)