CurrentBlue Cross Blue Shield - MassachusettsPolicy 064

Repository corticotropin injection (H.P. Acthar Gel) — medical necessity and investigational indications

Policy governing medical necessity and investigational indications for repository corticotropin injection for commercial members of Blue Cross Blue Shield of Massachusetts, including prior authorization and individual consideration processes.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyRepository corticotropin injection (H.P. Acthar Gel) — medical necessity and investigational indications

Policy CodePolicy 064

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization requests using the Formulary Exception/Prior Authorization form to Pharmacy Operations for coverage or individual consideration.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Infantile spasmsIndication considered medically necessary

Multiple other conditionsListed investigational/non-covered uses

CPT/HCPCSProcedure and drug codes listed

G40.82xDiagnosis codes included

Individual consideration

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Coverage Criteria

Medically necessary: Infantile spasms

Medically necessary indication: Infantile spasms — Covered when ALL of the following are met

For infantile spasms, randomized trials, a systematic review, and cohort data support use though evidence quality was variable; clinical input supports repository corticotropin injection as standard of care for this indication.

Investigational indications

Investigational indications — Not covered / investigational when ANY of the following apply

Evidence for noncorticosteroid-responsive conditions is insufficient (studies few, low-to-moderate quality, no clear benefit).

Denial Risk

Denial risk and administrative requirements

Prior authorization required; requests for indications that are not corticosteroid-responsive or for diagnostic adrenal testing are at high risk of denial.

Ensure documentation supports diagnosis of infantile spasms and rationale for repository corticotropin when requesting coverage.
Step therapy/administrative info: follow prior authorization process and any step-therapy requirements documented by the plan; provide prior treatments and justification if applicable.
Requests for use in tobacco cessation, acute gout, childhood epilepsy, or for diagnostic adrenal function testing are likely to be denied as investigational.

Coding

CPT CodesCPT

96372

Therapeutic, prophylactic or diagnostic injection (specify substance or drug); subcutaneous or intramuscular

HCPCS / Drug CodesHCPCS

Injection corticotropin, up to 40 units (Acthar Gel)	HCPCS drug descriptor listed
J3490	Unclassified drugs (Cortrophin Purified Gel)

ICD-10 Diagnosis CodesICD-10

G40.821	Epileptic spasms code range (includes infantile spasms)
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

Provider Actions & Administrative Requirements

Prior Authorization

Prior authorization required for Rx or medical benefit

Prior authorization is required for pharmacy or medical benefit coverage of repository corticotropin injection; requests must be submitted to Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department using the Formulary Exception/Prior Authorization form or the standard medication prior authorization eForm.

Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department, 25 Technology Place, Hingham, MA 02043 (see contact details in policy)

Step Therapy

Step therapy administrative and contact information

Step therapy and prior authorization processes are managed through Pharmacy Operations; contact information and instructions are provided in the policy for step therapy and prior authorization management.

Pharmacy Operations: Tel: 1-800-366-7778; Fax: 1-800-583-6289

Background

Repository corticotropin injection (H.P. Acthar Gel) is a purified, sterile preparation of the natural form of adrenocorticotropic hormone (ACTH) formulated in a gelatin vehicle for prolonged release. It is used to stimulate adrenal corticosteroid production and has been studied and used across a range of conditions described as corticosteroid-responsive. Evidence from randomized trials, systematic reviews, and cohort studies supports use in infantile spasms (West syndrome), but the overall quality of evidence is limited and heterogeneous for many other indications.

Definitions

Repository corticotropin injection — definition and formulation details

Generic nameRepository corticotropin injection (H.P. Acthar Gel)

Composition / formulationPurified, sterile natural adrenocorticotropic hormone (ACTH) in gelatin for prolonged release

Source of ACTHDerived from porcine pituitaries

Route of administrationIntramuscular or subcutaneous injection

Mechanism of actionStimulates the adrenal cortex to produce cortisol, corticosterone, and other hormones

Infantile spasms — definition and relevant ICD-10 code range

Clinical term