ModifiedUnitedHealthcarePolicy CSPA2025D0037S

Repository Corticotropin Injections (for Pennsylvania Only)

Medical benefit drug policy governing use and coverage criteria for repository corticotropin injections in the state of Pennsylvania, applying to UnitedHealthcare Community Plan members and providers.

Policy Summary

PayerUnitedHealthcare

PolicyRepository Corticotropin Injections (for Pennsylvania Only)

Policy CodePolicy CSPA2025D0037S

Change TypeAdded and removed ICD-10 diagnosis codes (operational)

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization per criteria, including diagnosis confirmation, required attestations, dosing limits, and authorization durations.

SourceLink

POLICY UPDATE CHANGES

Added ICD-10 diagnosis codes G35.A, G35.B0, G35.B1, G35.B2, G35.C0, G35.C1, G35.C2, and G35.D to the list of applicable codes.

Removed ICD-10 code G35 from the applicable diagnosis code list.

3proven indications

8new G35.* codes added

120 units/daymax daily dose (MS)

J0801, J0802example codes

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Coverage Criteria for Repository Corticotropin Injections

Covered Indications

Acthar Gel and Purified Cortrophin Gel are medically necessary when the specific indication's ALL criteria are met.

Infantile spasms (West Syndrome)

Diagnosis of infantile spasms (i.e., West Syndrome).
Age: Patient is less than 2 years old.
Caregiver administration attestation: Provider attestation that the caregiver is not able to be trained or is physically unable to administer the drug; provider must submit explanation (applies only to medical benefit review).
Dosing is in accordance with the FDA-approved labeling, nationally recognized compendia, or peer-reviewed medical literature.
Authorization duration: Authorization will be for no longer than 1 month.

Opsoclonus-myoclonus syndrome (OMS, Kinsbourne)

Diagnosis of opsoclonus-myoclonus syndrome (i.e., Kinsbourne Syndrome).
Caregiver administration attestation: Provider attestation that the caregiver is not able to be trained or is physically unable to administer the drug; provider must submit explanation (applies only to medical benefit review).
Authorization duration: Authorization will be for no longer than 12 months.

Multiple sclerosis — acute exacerbation

Diagnosis and provider: Diagnosis of multiple sclerosis was made by, or in consultation with, a neurologist.
Prior steroid therapy or intolerance: Either: (1) Patient has tried and failed therapy with both an oral and an intravenous formulation of a corticosteroid in the past 60 days; OR (2) Patient has a documented intolerance or contraindication to corticosteroid therapy.
Dose and duration: Dose does not exceed 120 units daily and is not given for more than 3 weeks.

General Coverage Guidance

Policy use and clinical references

Policy interpretation: Providers must reference federal, state, or contractual benefit plan requirements when deciding coverage; UnitedHealthcare policies are informational and may be supplemented by third-party criteria (e.g., InterQual).

No specific medical necessity criteria present in this segment.

Use of Acthar Gel and Purified Cortrophin Gel is discussed in this policy as unproven/not medically necessary for a range of disorders. These 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 remit proteinuria in idiopathic or lupus-associated nephrotic syndrome without uremia); ophthalmic diseases (severe acute and chronic allergic and inflammatory eye conditions including keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation); respiratory disease (symptomatic sarcoidosis); and rheumatic disorders (psoriatic arthritis, rheumatoid arthritis including juvenile rheumatoid arthritis, ankylosing spondylitis, and acute gouty arthritis).

The policy also states that use of these products for any indication outside of the proven indications will be reviewed for medical necessity on a case‑by‑case basis.

This Medical Benefit Drug Policy is informational and does not replace the terms of a member’s benefit contract. Providers must reference federal, state, or contractual benefit plan requirements when deciding coverage because those requirements govern in the event of a conflict with this policy.

UnitedHealthcare has determined that Acthar Gel and Purified Cortrophin Gel are unproven and not medically necessary for the following listed conditions: serum sickness; atopic dermatitis; systemic lupus erythematosus; systemic dermatomyositis (polymyositis); severe erythema multiforme; Stevens–Johnson syndrome; severe psoriasis; induction of diuresis or remission of proteinuria in idiopathic or lupus-associated nephrotic syndrome without uremia; severe acute and chronic inflammatory ophthalmic conditions (including keratitis, iritis, iridocyclitis, posterior uveitis and choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation); symptomatic sarcoidosis; psoriatic arthritis; rheumatoid arthritis (including juvenile rheumatoid arthritis); ankylosing spondylitis; and acute gouty arthritis.

Requests for use in these indications will be reviewed for medical necessity on a case‑by‑case basis, and the policy notes that these uses are more costly than alternatives with similar therapeutic expectations.

Within the document segment provided there are no additional explicit conditions listed that are designated as not medically necessary beyond those enumerated in the unproven/unproven-not medically necessary lists; providers should refer to the full policy and the member’s benefit contract for plan‑specific exclusions or limitations.

Coding and Dosing

HCPCS CodesHCPCS

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

ICD-10 CodesICD-10

G25.3	Myoclonus
G25.9	Extrapyramidal and movement disorder, unspecified
G35.A	Relapsing-remitting multiple sclerosis
G35.B0	Primary progressive multiple sclerosis, unspecified
G35.B1	Active primary progressive multiple sclerosis
G35.B2	Non-active primary progressive multiple sclerosis
G35.C0	Secondary progressive multiple sclerosis, unspecified
G35.C1	Active secondary progressive multiple sclerosis
G35.C2	Non-active secondary progressive multiple sclerosis
G35.D	Multiple sclerosis, unspecified

1–10 of 15

1/2

Applicable ICD-10 Diagnosis Codes (updated)ICD-10

G35.A	Added ICD-10 diagnosis code
G35.B0	Added ICD-10 diagnosis code
G35.B1	Added ICD-10 diagnosis code
G35.B2	Added ICD-10 diagnosis code
G35.C0	Added ICD-10 diagnosis code
G35.C1	Added ICD-10 diagnosis code
G35.C2	Added ICD-10 diagnosis code
G35.D	Added ICD-10 diagnosis code
G35	Removed ICD-10 diagnosis code

inv-10: Maximum daily dose for MS exacerbations — <= 120 units daily

Maximum daily doseDose does not exceed 120 units daily for multiple sclerosis acute exacerbations.

Maximum durationNot given for more than 3 weeks for MS exacerbations.

Related requirementDiagnosis must be made by or in consultation with a neurologist.

Prior therapy conditionPatient must have tried and failed both oral and IV corticosteroids in past 60 days or have documented intolerance/contraindication.

Provider Actions and Requirements

Documentation Required

Coding inclusion is not coverage

Coding inclusion is not coverage: The presence of procedure, diagnosis, or drug codes in this policy (for example, J0801, J0802, or listed ICD-10 codes) is for reference only and does not guarantee coverage or payment. Benefit coverage is determined by applicable federal, state, and contractual requirements and other plan terms; inclusion of a code does not imply a right to reimbursement.

J0801, J0802 (examples)
See Applicable Codes — listing does not imply coverage

Documentation Required

MS diagnosis and prior therapy documentation

MS diagnosis and prior therapy documentation: For acute multiple sclerosis exacerbations, the diagnosis must have been made by, or in consultation with, a neurologist. Documentation must include prior corticosteroid therapy details: either evidence the patient tried and failed both an oral and an IV corticosteroid within the past 60 days, or documentation of an intolerance or contraindication to corticosteroid therapy. Also document prescribed dose (must not exceed 120 units daily) and duration (not more than 3 weeks).

Diagnosis by or in consultation with a neurologist

Background

Repository corticotropin is an adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete corticosteroids (including cortisol, corticosterone and aldosterone) and weak androgens, and it also binds to melanocortin receptors. Prolonged high‑dose use can induce adrenal hypertrophy and sustain increased corticosteroid output; daily high‑dose administration increases serum and CSF cortisol while negative physiologic feedback reduces endogenous ACTH.

Definitions and Clinical Terms

inv-21: Repository corticotropin — definition and pharmacology

DefinitionRepository corticotropin is an adrenocorticotropic hormone (ACTH) analogue (repository corticotropin injection).

Primary pharmacologic actionStimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and weak androgens.

Additional pharmacologyBinds to melanocortin receptors and has trophic effects on the adrenal cortex mediated by cyclic AMP; prolonged large-dose use induces adrenal hyperplasia and hypertrophy.

Physiologic feedbackElevated plasma cortisol suppresses endogenous ACTH release via negative corticosteroid feedback.

inv-22: Infantile spasms (West Syndrome) — definition, indication age limits

DefinitionInfantile spasms (West Syndrome) is an epilepsy syndrome in infants characterized by spasms and associated EEG findings.