CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Repository corticotropin injection (Acthar Gel, Cortrophin Gel) — Clinical coverage policy

Clinical coverage policy for repository corticotropin injection governing Medicaid and Commercial members; excludes Part B Medicare-Medicaid Plan (MMP) members for the medical benefit effective 10/01/2023.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRepository corticotropin injection (Acthar Gel, Cortrophin Gel) — Clinical coverage policy

Policy CodePolicy N/A

Change TypeNo material change

Effective Date01/01/2020

Next Review DateN/A

Key ActionObtain prior authorization; initial coverage is reviewed prospectively and is limited to one month when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

01/01/2020Effective date

04/30/2025Most recent review

Medicaid & CommercialScope

ExcludedMMP Part B

J0801,J0802HCPCS codes

Coverage Criteria

Infantile Spasms (Acthar / Cortrophin)

Covered when ALL of the following are met:

Infantile Spasms coverage criteria

Clinical documentation indicating patient has a diagnosis of Infantile Spasms (West Syndrome).
Patient is less than 24 months old.age <24 months
Must be used as monotherapy.
Documentation that patient does not have a suspected congenital infection.
If the request is for Acthar Gel, the patient must have a documented contraindication, inadequate response, or intolerance to Cortrophin Gel.
Dose does not exceed 75 units/m² intramuscularly given twice daily for 2 weeks, then taper the dose over a 2-week period (example taper: 30 units/m² in the morning for 3 days; 15 units/m² in the morning for 3 days; 10 units/m² in the morning for 3 days; and 10 units/m² every other morning for 6 days).dose limit 75 units/m² twice daily for 2 weeks with specified taper
Example taper sequence provided in source.

Effective 10/01/2023: Repository corticotropin injection (Acthar Gel, Cortrophin Gel) is NOT COVERED for the Part B Medical Benefit for Medicare‑Medicaid Plan (MMP) members.

Therapies are considered investigational when used at a dose or for a condition other than those recognized as medically accepted indications per standard reference compendia (for example AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Lexi‑Drugs) or peer‑reviewed published literature. Neighborhood does not provide coverage for investigational uses.

Coding and Billing

Applicable HCPCS/CPT CodesHCPCSCovered

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

mixed

No codes listed

Maximum units for infantile spasms (billable)

Maximum billable units35 billable units every 28 days (1 billable unit = 40 units)

Measurement periodPer 28-day period

Unit definition1 billable unit = 40 units

Applicable indicationInfantile spasms dosing limit

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Coverage of Repository corticotropin injection (Acthar Gel, Cortrophin Gel) requires prior authorization and will be reviewed prospectively based on policy criteria. Initial coverage duration is 1 month.

Initial coverage duration: 1 month

Step Therapy

Step-Therapy Requirement for Acthar Gel

If the request is for Acthar Gel for infantile spasms, the patient must have a documented contraindication, inadequate response, or intolerance to Cortrophin Gel before Acthar will be approved.

Applies specifically to Infantile Spasms (West Syndrome) requests for Acthar Gel

Definitions

Infantile spasms (West Syndrome) — definition and age indication

DefinitionA seizure disorder in infants characterized by spasms and hypsarrhythmia on EEG (West Syndrome).

Age indicationFDA-indicated for treatment in children under 2 years of age (<24 months).

Clinical features referencedClinical response endpoint includes suppression of clinical spasms and hypsarrhythmia on video EEG following treatment.

Treatment contextActhar Gel demonstrated efficacy in clinical trial versus prednisone for infantile spasms.

Background

Acthar (repository corticotropin injection) is FDA‑indicated for the treatment of infantile spasms in children under age 2 and is included in this policy alongside Cortrophin Gel. The policy rationale notes review by the plan P&T committee and states criteria were adopted to align use with FDA labeling and relevant clinical literature to promote appropriate, safe, and cost‑effective use. Acthar carries multiple safety warnings and its role in infantile spasms is supported by clinical evidence referenced in the summary of evidence.