CurrentViva Health PlanPolicy IC-0003

Corticotropin-ACTH: Acthar Gel and Cortrophin Gel

Customize your policy alerts

Sign up for vivahealthplan Policy IC-0003 alerts

Get alerted when Policy IC-0003 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

This policy governs prior authorization and medical necessity coverage for Acthar Gel and Cortrophin Gel repository corticotropin injection. Coverage is limited to specified infantile spasms and multiple sclerosis criteria, dosing limits, and renewal requirements.

Policy Summary

PayerViva Health Plan

PolicyCorticotropin-ACTH: Acthar Gel and Cortrophin Gel

Policy CodePolicy IC-0003

Change TypeNo material change

Effective DateN/A

Last ReviewAug 4, 2026

Next Review DateN/A

Key ActionObtain prior authorization for repository corticotropin injection; initial approval is valid for 30 days and renewal may be requested monthly when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

30 daysInitial authorization validity

35 units/28 daysInfantile spasms maximum

63 units/21 daysMultiple sclerosis maximum

Under 2 yearsInfantile spasms age requirement

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentViva Health PlanPolicy IC-0003

Corticotropin-ACTH: Acthar Gel and Cortrophin Gel

Customize your policy alerts

Sign up for vivahealthplan Policy IC-0003 alerts

Get alerted when Policy IC-0003 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerViva Health Plan

PolicyCorticotropin-ACTH: Acthar Gel and Cortrophin Gel

Policy CodePolicy IC-0003

Change TypeNo material change

Effective DateN/A

Last ReviewAug 4, 2026

Next Review DateN/A

Key ActionObtain prior authorization for repository corticotropin injection; initial approval is valid for 30 days and renewal may be requested monthly when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

30 daysInitial authorization validity

35 units/28 daysInfantile spasms maximum

63 units/21 daysMultiple sclerosis maximum

Under 2 yearsInfantile spasms age requirement

Multiple sclerosis age requirement

2Covered indications

Coverage Criteria

Initial Therapy — Infantile Spasms

Covered when ALL of the following are met:

Infantile Spasms (West Syndrome)

Age: Member is under 2 years of ageunder 2 years
Diagnosis: Clinical documentation indicates a diagnosis of infantile spasms (West Syndrome)
Treatment use: Must be used as monotherapymonotherapy
Contraindications: Member does not have any FDA-labeled contraindications to the requested agent, such as suspected congenital infection or intravenous administration

Initial Therapy — Multiple Sclerosis

Covered when ALL of the following are met:

Multiple Sclerosis

Age: Patient is 18 years or older18 years or older
Pseudo-exacerbation excluded: Prescriber rules out pseudo-exacerbation from other precipitation factors, such as infection, pain, stress, or premenstrual syndrome
Acute exacerbation duration: Symptoms of acute exacerbation last at least 24 hoursat least 24 hours
Immunomodulator therapy:

Renewal Therapy

Covered for renewal when ALL of the following are met:

Continued indication criteria: Member continues to meet indication-specific relevant criteria identified in the initial approval criteria, such as concomitant therapy requirements and performance status
Disease response with treatment is demonstrated by resolution of symptoms and/or normalization of laboratory testsresolution or normalization
Safety: There is an absence of unacceptable toxicity from the drug
Examples include severe infections, elevated blood pressure, salt and water retention, gastrointestinal perforation and bleeding, gastric ulcer, behavioral or mood disturbances, posterior subcapsular cataracts, glaucoma, and anaphylaxis.

Repository corticotropin injection is not supported for indications, including additional uses listed in product labeling, when substantial clinical evidence is lacking. Coverage is therefore limited to indications meeting the policy’s specified medical-necessity criteria.

Initial Therapy Criteria

Initial Therapy — Infantile Spasms

Initial authorization may be provided when ALL of the following are met:

Infantile Spasms (West Syndrome)

Age: Member is under 2 years of ageunder 2 years
Diagnosis: Clinical documentation indicates a diagnosis of infantile spasms (West Syndrome)
Monotherapy: The requested agent must be used as monotherapymonotherapy

Continuation and Renewal

Renewal Therapy

Renewal authorization may be provided when ALL of the following are met:

Renewal Criteria

Continued indication criteria: Member continues to meet indication-specific relevant criteria identified in the initial approval section
Disease response is demonstrated by resolution of symptoms and/or normalization of laboratory tests
No unacceptable toxicity: Member has no unacceptable toxicity from the drug
Examples include severe infections, elevated blood pressure, salt and water retention, gastrointestinal perforation and bleeding, gastric ulcer, behavioral or mood disturbances, posterior subcapsular cataracts, glaucoma, and anaphylaxis.

Coding and Quantity Parameters

Covered HCPCS CodesHCPCSCovered

J0801	Injection, corticotropin (acthar gel), up to 40 units; 1 billable unit = up to 40 units (applicable to Acthar Gel ONLY)
J0802	Injection, corticotropin (ani), up to 40 units; 1 billable unit = up to 40 units (applicable to Cortrophin Gel ONLY)

Covered NDC CodesNDCCovered

63004-8710-xx	Acthar Gel 80 units/mL (5 mL multi-dose vial)
62559-0860-xx	Purified Cortrophin Gel 80 USP units/mL (1 mL multi-dose vial)
62559-0860-xx	Purified Cortrophin Gel 400 USP units/5 mL (5 mL multi-dose vial)

Covered Diagnosis CodesICD-10Covered

G35	Multiple sclerosis
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

Infantile Spasms Dosing Limit

IndicationInfantile spasms

Maximum quantity35 billable units

Limit periodEvery 28 days

Multiple Sclerosis Dosing Limit

IndicationMultiple sclerosis

Maximum quantity63 billable units

Limit period

Provider Requirements and Denial Conditions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorization is valid for 1 month (30 days) and may be renewed for additional 1-month (30-day) periods when renewal criteria are met.

Initial authorization: 30 days.
Renewal authorization: 30 days per renewal period.

Step Therapy

Corticosteroid Trial or Intolerance Required

For multiple sclerosis, the member must have a history of inadequate response to or intolerance of a corticosteroid for the current or a previous acute exacerbation.

Qualifying corticosteroids may include IV methylprednisolone, IV dexamethasone, or oral prednisone.

Unsupported block type: step_therapy espontaneous?

Policy Background

This policy applies to the covered repository corticotropin injection products Acthar Gel and Cortrophin Gel. It addresses infantile spasms (West Syndrome) in children under 2 years of age and acute exacerbations of multiple sclerosis in adults 18 years or older, subject to the applicable coverage criteria, authorization requirements, and quantity limits.

Definitions

Pseudo-Exacerbation

DefinitionWorsening of multiple sclerosis symptoms attributable to other precipitation factors rather than a new acute exacerbation

Examples of precipitation factorsInfection, pain, stress, or premenstrual syndrome

Distinction from acute exacerbationThe prescriber must rule out pseudo-exacerbation before coverage for an acute multiple sclerosis exacerbation is considered

Infantile Spasms (West Syndrome)

Alternate nameWest Syndrome

Age contextMember is under 2 years of age

Treatment context

Step Therapy Requirements

Step	Requirement	Applies to
1	History of inadequate response to or intolerance of a corticosteroid, such as IV methylprednisolone, IV dexamethasone, or oral prednisone, for the current or a previous acute exacerbation.	Multiple sclerosis acute exacerbation

Step	Requirement	Timing or exception
1	Currently stable on an immunomodulator, such as dimethyl fumarate, glatiramer acetate, interferon beta 1a, interferon beta 1b, fingolimod, natalizumab, or teriflunomide.	Within the last 30 days; requirement does not apply if the immunomodulator is contraindicated.

Quantity Limits

Repository Corticotropin Injection for Infantile Spasms

IndicationInfantile spasms

Maximum quantity35 billable units

Limit periodEvery 28 days

Repository Corticotropin Injection for Multiple Sclerosis

IndicationMultiple sclerosis

Maximum quantity63 billable units

Limit periodEvery 21 days

Policy Summary

PayerViva Health Plan

PolicyCorticotropin-ACTH: Acthar Gel and Cortrophin Gel

Policy CodePolicy IC-0003

Change TypeNo material change

Effective DateN/A

Last ReviewAug 4, 2026

Next Review DateN/A

Key ActionObtain prior authorization for repository corticotropin injection; initial approval is valid for 30 days and renewal may be requested monthly when criteria are met.

SourceLink

On This Page

Patient is currently stable within the last 30 days on an immunomodulator, such as dimethyl fumarate, glatiramer acetate, interferon beta 1a, interferon beta 1b, fingolimod, natalizumab, or teriflunomide, unless contraindicated

stable within the last 30 days

Corticosteroid response: Patient has a history of inadequate response to or intolerance of a corticosteroid, such as IV methylprednisolone, IV dexamethasone, or oral prednisone, for the current or previous acute exacerbationinadequate response or intolerance

Contraindications: Member does not have any FDA-labeled contraindications to the requested agent

Examples include suspected congenital infection and intravenous administration.

Initial Therapy — Multiple Sclerosis

Initial authorization may be provided when ALL of the following are met:

Multiple Sclerosis

Age: Patient is 18 years or older18 years or older
Pseudo-exacerbation excluded: Prescriber must rule out pseudo-exacerbation from other precipitation factors
Examples include infection, pain, stress, and premenstrual syndrome.
Exacerbation duration: Symptoms of acute exacerbation last at least 24 hoursat least 24 hours
Immunomodulator stability: Patient is currently stable within the last 30 days on an immunomodulator unless contraindicatedstable within the last 30 days
Corticosteroid history: Patient has a history of inadequate response to or intolerance of a corticosteroid for the current or previous acute exacerbationinadequate response or intolerance

Documentation Required

Infantile Spasms Documentation

Document the infantile spasms (West syndrome) diagnosis and confirm that the member is under 2 years of age. The requested agent must be used as monotherapy.

Include clinical documentation supporting the diagnosis.
Confirm treatment is not being combined with another therapy for the indication.

Documentation Required

Multiple Sclerosis Documentation

For multiple sclerosis, document that the member is at least 18 years old, the acute exacerbation has lasted at least 24 hours, and pseudo-exacerbation has been ruled out. Documentation must also address stable qualifying immunomodulator therapy and corticosteroid inadequacy or intolerance.

Rule out precipitation factors such as infection, pain, stress, or premenstrual syndrome.
Document current or previous acute exacerbation and relevant treatment history.

Documentation Required

Renewal Documentation

Renewal requires that the member continues to meet the applicable indication-specific criteria, demonstrates response to treatment, and has no unacceptable drug toxicity.

Document continued relevant criteria, including applicable concomitant therapy requirements and performance status.
Document resolution of symptoms and/or normalization of laboratory tests.
Document absence of unacceptable toxicity, such as severe infection, hypertension, fluid retention, gastrointestinal complications, serious psychiatric effects, cataracts, glaucoma, or anaphylaxis.

Denial Risk

Unsupported Indication

Use of repository corticotropin injection for indications beyond those supported by substantial clinical evidence is not supported under this policy and may result in denial.

Indications not supported by substantial clinical evidence are not covered solely because they appear in historical product labeling or legacy approval materials.

Denial Risk

Initial Criteria Not Met

Initial authorization may be denied when required criteria are not met, including age, diagnosis, treatment approach, exacerbation documentation, concomitant therapy, or corticosteroid requirements.

Infantile spasms: member must be under 2 years of age, have documented West syndrome, and receive the agent as monotherapy.
Multiple sclerosis: member must be at least 18 years old; symptoms must last at least 24 hours; pseudo-exacerbation must be excluded; stable qualifying immunomodulator therapy must be documented unless contraindicated; and corticosteroid inadequacy or intolerance must be established.

Denial Risk

Renewal Criteria Not Met

Renewal may be denied when indication-specific criteria are no longer met, treatment response is not demonstrated, or unacceptable toxicity is present or insufficiently documented.

Confirm continued applicable criteria and required therapy.
Document symptom resolution and/or laboratory improvement.
Document absence of unacceptable toxicity.

Billing Rule

Dosing Limit Exceeded

Claims may be denied when billed units exceed the applicable dose or time-period limit.

Infantile spasms: maximum 35 billable HCPCS units every 28 days.
Multiple sclerosis: maximum 63 billable HCPCS units every 21 days.

Denial Risk

FDA-Labeled Contraindication

Authorization may be denied when the member has an FDA-labeled contraindication to the requested agent.

For infantile spasms, examples include suspected congenital infection or requested intravenous administration.

Note

Medicare Policy Compliance

For Medicare members, apply the Medicare Benefit Policy Manual requirements for outpatient Part B drugs and comply with applicable CMS coverage policies.

Review applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs).
Use the CMS Medicare Coverage Database to identify applicable policies: https://www.cms.gov/medicare-coverage-database/search.aspx.
Additional indications may be applied at the discretion of the health plan.

Repository corticotropin injection must be used as monotherapy