Aetna modified CPB 0762 for repository corticotropin injection (Acthar Gel and Purified Cortrophin Gel), effective December 9, 2025. Here's what billing teams need to know.
Aetna, a CVS Health company, updated Clinical Policy Bulletin CPB 0762 governing repository corticotropin injection coverage policy for commercial medical plans. The policy now draws a sharp line: Acthar Gel is covered for infantile spasms in children under two years old, and virtually every other indication is denied. If your team bills J0801 or J0802, this policy change has direct financial exposure you need to address now.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Repository Corticotropin Injection (Acthar Gel and Purified Cortrophin Gel) |
| Policy Code | CPB 0762 Aetna |
| Change Type | Modified |
| Effective Date | December 9, 2025 |
| Impact Level | High |
| Specialties Affected | Pediatric neurology, neurology, rheumatology, nephrology, pulmonology, ophthalmology |
| Key Action | Audit all active Acthar Gel and Purified Cortrophin Gel claims for non-infantile-spasms indications immediately — denials are coming |
Aetna Repository Corticotropin Injection Coverage Criteria and Medical Necessity Requirements 2025
This is one of the most restrictive coverage policies Aetna runs. The updated Aetna repository corticotropin injection coverage policy approves only one indication: infantile spasms in members under two years of age, using Acthar Gel only.
To meet medical necessity for initial approval, the member must be under age two and diagnosed with infantile spasms (coded as G40.821, G40.822, G40.823, or G40.824 — West's syndrome). Purified Cortrophin Gel is not covered under any circumstance, even for this indication. That's not an oversight. The policy explicitly names Acthar Gel only for the covered indication.
Continuation of therapy clears only when the member shows substantial clinical benefit from treatment. Aetna does not define "substantial clinical benefit" numerically in this bulletin, which means your prior authorization renewals need strong clinical documentation. Vague progress notes will get denied.
Precertification is required before dispensing for all Aetna participating providers and members in applicable plan designs. Call (866) 752-7021 or fax (888) 267-3277 to start the process. Statement of Medical Necessity forms are available through Aetna's Specialty Pharmacy Precertification page. Do not dispense or administer before prior authorization is confirmed — reimbursement depends on it.
The real issue here is scope. The ICD-10-CM code list attached to this policy runs to 481 codes. It spans multiple sclerosis (G35), sarcoidosis (D86.x), acquired hemolytic anemias (D59.x), respiratory tuberculosis (A15.x), lymphatic malignancies (C81.00–C96.9), dry eye syndrome (H04.12x), and dozens more conditions. But those codes are listed as diagnosis codes attached to the CPB — not as covered indications. Every one of those conditions falls under the "experimental, investigational, unproven, or not medically necessary" designation for actual coverage purposes. Don't let a long code list give your team false confidence.
Aetna Repository Corticotropin Injection Exclusions and Non-Covered Indications
Aetna classifies all indications other than infantile spasms in members under age two as experimental, investigational, unproven, or not medically necessary. That list is long.
Historically, Acthar Gel was marketed for dozens of conditions — multiple sclerosis exacerbations, nephrotic syndrome, rheumatoid arthritis flares, systemic lupus, and more. Aetna covers none of them under this policy. Not as a second-line therapy. Not after treatment failure. Not at all.
Purified Cortrophin Gel (the ANI Pharmaceuticals formulation, billed as J0802) is also excluded for all indications. If you have patients receiving Purified Cortrophin Gel under any diagnosis, those claims will be denied under this coverage policy. Pull those accounts now.
If your practice has been relying on off-label use of corticotropin injection for conditions like amyotrophic lateral sclerosis (G12.21), dry eye syndrome (H04.12x), or sarcoidosis (D86.x), the Aetna denial is automatic under this policy. Talk to your compliance officer before submitting any of those claims.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Infantile spasms (West's syndrome) in members under age 2 | Covered | J0801, G40.821–G40.824 | Acthar Gel only; precertification required |
| Continuation of therapy for infantile spasms | Covered | J0801, G40.821–G40.824 | Requires documentation of substantial clinical benefit |
| All other indications (MS, nephrotic syndrome, lupus, RA, sarcoidosis, etc.) | Not Covered | J0801, J0802 | Classified as experimental, investigational, or not medically necessary |
| Purified Cortrophin Gel (any indication) | Not Covered | J0802 | No covered indications under this policy |
Aetna Repository Corticotropin Injection Billing Guidelines and Action Items 2025
The effective date of December 9, 2025 is already in effect. If your team has not acted yet, act now.
| # | Action Item |
|---|---|
| 1 | Pull all active Acthar Gel and Purified Cortrophin Gel authorizations. Review every open prior auth for J0801 and J0802. Any auth for an indication other than infantile spasms (G40.821–G40.824) in a member under age two is at risk of denial on renewal. |
| 2 | Stop billing J0802 for Aetna commercial members. Purified Cortrophin Gel has no covered indication under CPB 0762. Any J0802 claim against an Aetna commercial plan will deny on medical necessity grounds. Remove Aetna from your J0802 charge capture for commercial lines. |
| 3 | Tighten your clinical documentation for infantile spasms continuation requests. Aetna's continuation criterion is "substantial clinical benefit." Your medical director needs to document response to therapy specifically — seizure frequency reduction, EEG improvement, developmental outcomes. Generic "tolerating well" notes will not pass review. |
| 4 | Audit claims submitted after December 9, 2025. Any corticotropin injection claim billed to Aetna commercial after the effective date for a non-covered indication is a denial waiting to happen. Run a report on J0801 and J0802 claims by diagnosis code. Flag everything outside G40.821–G40.824. |
| 5 | Update your precertification workflow. Precertification runs through (866) 752-7021 or fax (888) 267-3277. Make sure your authorization team knows that the SMN form is required and that Purified Cortrophin Gel is not an eligible product regardless of clinical justification. |
| 6 | Brief your specialty teams. Neurologists, rheumatologists, and nephrologists who have used Acthar Gel or Purified Cortrophin Gel for non-spasms indications need to know these claims will deny. Set that expectation before they write the order, not after the claim comes back. |
| 7 | Note the Medicare carve-out. CPB 0762 covers commercial plans only. Aetna uses a separate Medicare Part B criteria set for corticotropin injection. If you bill both commercial and Medicare Advantage through Aetna, your billing guidelines must reflect separate criteria for each population. Confirm which criteria apply to each patient before submitting. |
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
CPT, HCPCS, and ICD-10 Codes for Repository Corticotropin Injection Under CPB 0762
Covered HCPCS Codes (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J0801 | HCPCS | Injection, corticotropin (Acthar Gel), up to 40 units |
| J0802 | HCPCS | Injection, corticotropin (ANI), up to 40 units |
Note on J0802: This code appears in the "covered if selection criteria are met" group in the policy's code table, but the narrative criteria explicitly exclude Purified Cortrophin Gel from all indications. In practice, no selection criteria exist that would cover J0802 under this policy. This is a contradictory presentation — the code table and the criteria text conflict. If you are billing J0802 for Aetna commercial members, escalate this to your compliance officer before submitting. Claim denial risk is high.
Other CPT Codes Related to CPB 0762
| Code | Type | Description |
|---|---|---|
| 96372 | CPT | Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular |
CPT 96372 covers the administration of the injection itself. It is listed as a related code, not a separately covered benefit. Billing 96372 alongside J0801 for a covered infantile spasms case is appropriate, but confirm your payer contract on bundling rules before assuming separate reimbursement.
Key ICD-10-CM Diagnosis Codes
The policy attaches 481 ICD-10-CM codes to CPB 0762. Most appear as contextual reference codes — they document what conditions the policy addresses — not as covered indications. The only codes that map to actual coverage under this policy are the infantile spasms/West's syndrome codes:
| Code | Description |
|---|---|
| G40.821 | Epileptic spasms, not intractable, without status epilepticus |
| G40.822 | Epileptic spasms, not intractable, with status epilepticus |
| G40.823 | Epileptic spasms, intractable, without status epilepticus |
| G40.824 | Epileptic spasms, intractable, with status epilepticus |
A selection of other ICD-10-CM codes attached to this policy (representing the range of conditions Aetna explicitly classifies as non-covered under this bulletin):
| Code | Description |
|---|---|
| A15.0–A15.9 | Respiratory tuberculosis (when used concurrently with antituberculous chemotherapy) |
| A17.0 | Tuberculous meningitis (with subarachnoid block or impending block) |
| B02.39 | Other herpes zoster eye disease |
| B75 | Trichinellosis (with neurologic or myocardial involvement) |
| C81.00–C96.9 | Malignant neoplasm of lymphatic and hematopoietic tissue |
| D59.0–D59.9 | Acquired hemolytic anemias |
| D61.01 | Constitutional (pure) red cell aplasia |
| D61.89 | Other specified aplastic anemias and other bone marrow failure syndromes |
| D69.59 | Other secondary thrombocytopenia (in adults) |
| D86.0–D86.9 | Sarcoidosis (symptomatic, including pulmonary, neurosarcoidosis, ocular) |
| E06.1 | Subacute thyroiditis (nonsuppurative) |
| E83.52 | Hypercalcemia (with cancer) |
| G12.21 | Amyotrophic lateral sclerosis |
| G35 | Multiple sclerosis (acute exacerbations) |
| H04.121–H04.129 | Dry eye syndrome |
| H10.11–H10.33 | Conjunctivitis (severe acute and chronic allergic and inflammatory processes) |
The full 481-code ICD-10 list is available in the complete policy at CPB 0762 on Aetna's site. For billing purposes, only the G40.82x codes represent a path to coverage.
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