Aetna modified CPB 1064 for crovalimab-akkz (PiaSky), effective December 4, 2025. Here's what billing teams need to do.
Aetna, a CVS Health company, updated its crovalimab-akkz (PiaSky) coverage policy under CPB 1064 in the Aetna system. This policy governs commercial medical plan reimbursement for PiaSky — a complement inhibitor used to treat paroxysmal nocturnal hemoglobinuria (PNH). The primary HCPCS code at stake is J1307 (injection, crovalimab-akkz, 10 mg), billed alongside administration codes CPT 96401, 96402, 96413, 96414, and 96415, and tied to ICD-10-CM D59.5.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna |
| Policy | Crovalimab-akkz (PiaSky) |
| Policy Code | CPB 1064 |
| Change Type | Modified |
| Effective Date | December 4, 2025 |
| Impact Level | High |
| Specialties Affected | Hematology, Oncology, Infusion Centers, Specialty Pharmacy |
| Key Action | Verify all six initial approval criteria are documented before submitting precertification via (866) 752-7021 |
Aetna Crovalimab-akkz (PiaSky) Coverage Criteria and Medical Necessity Requirements 2025
The Aetna crovalimab-akkz coverage policy requires prior authorization for every claim. There are no exceptions for participating providers or plan members in applicable designs. Call (866) 752-7021 or fax (888) 267-3277 to submit precertification. The Site of Care Utilization Management Policy also applies — your infusion site must meet Aetna's criteria before you bill J1307 or any of the 96413-series codes.
Initial Approval — Six Criteria, All Required
Aetna considers crovalimab-akkz medically necessary only when all six of the following are met:
| # | Covered Indication |
|---|---|
| 1 | The member is 13 years of age or older. |
| 2 | The member weighs at least 40 kg. |
| 3 | PNH diagnosis is confirmed by detecting a deficiency of glycosylphosphatidylinositol-anchored proteins (GPI-APs) — specifically, at least 5% PNH cells or at least 51% GPI-AP deficient polymorphonuclear cells. |
| 4 | Flow cytometry is used to demonstrate the GPI-AP deficiency. Lab reports must reflect this method specifically. |
| 5 | The member shows clinical manifestations of disease — for example, lactate dehydrogenase (LDH) greater than 1.5× the upper limit of normal (ULN), thrombosis, renal dysfunction, pulmonary hypertension, or dysphagia. |
| 6 | The drug will not be used in combination with another complement inhibitor — including Empaveli, Fabhalta, Soliris, or Ultomiris. |
That sixth criterion is the one your team will miss under pressure. The policy is explicit: crovalimab-akkz is not medically necessary if the member is also on another complement inhibitor. If your prescriber is transitioning a patient from Soliris (eculizumab, billed as J1299) or Ultomiris (ravulizumab-cwvz, billed as J1303), the switch must be complete before authorization. Any overlap disqualifies the claim.
Continuation of Therapy — Reauthorization Criteria
Reauthorization requires three criteria, all of which must be met:
| # | Covered Indication |
|---|---|
| 1 | No evidence of unacceptable toxicity or disease progression on the current regimen. |
| 2 | The member shows a positive response — for example, improvement in hemoglobin levels or normalization of LDH. |
| 3 | The drug remains off-combination with any other complement inhibitor. |
The reauthorization bar is lower than initial approval, but documentation of response is non-negotiable. Pull LDH trends and hemoglobin values before you submit. Vague progress notes will not get you through prior auth.
Aetna Crovalimab-akkz Exclusions and Non-Covered Indications
Aetna considers all uses of crovalimab-akkz outside PNH as experimental, investigational, or unproven. Full stop. This is not a policy with a nuanced off-label list — if the claim doesn't map to ICD-10-CM D59.5 and meet all six initial criteria, it won't be covered.
Combination therapy with other complement inhibitors is also excluded. This rules out concurrent billing of J1307 alongside J1299 (eculizumab) or J1303 (ravulizumab-cwvz) for the same indication. If your charge capture is pulling both codes for the same member on the same date of service, that's a claim denial waiting to happen.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| PNH in members ≥13 years, ≥40 kg, GPI-AP deficiency confirmed by flow cytometry, with clinical manifestations | Covered | J1307, D59.5, CPT 96401–96415 | All six initial criteria must be met; prior auth required |
| Continuation of PNH therapy with documented positive response | Covered | J1307, D59.5, CPT 96401–96415 | Reauthorization required; LDH/hemoglobin documentation needed |
| PNH in members under 13 years or under 40 kg | Not Covered | D59.5 | Age and weight thresholds are hard stops |
| PNH in combination with another complement inhibitor (Empaveli, Fabhalta, Soliris, Ultomiris) | Not Covered | — | Concurrent complement inhibitor use disqualifies the claim |
| Any off-label use outside PNH | Experimental / Not Covered | — | All other indications are excluded under CPB 1064 |
Aetna Crovalimab-akkz (PiaSky) Billing Guidelines and Action Items 2025
These are the concrete steps your billing team needs to take now. The effective date of December 4, 2025 is already past — if you're billing J1307 and haven't audited your process against this modified policy, do it today.
| # | Action Item |
|---|---|
| 1 | Update your prior auth workflow for CPB 1064. Precertification is required for every claim. Use (866) 752-7021 for phone submissions or (888) 267-3277 for fax. If your team uses Statement of Medical Necessity (SMN) forms, pull them from Aetna's Specialty Pharmacy Precertification page. Don't rely on approval for a prior auth submitted before the December 4, 2025 effective date — confirm it reflects the current criteria. |
| 2 | Build a documentation checklist that maps to all six initial criteria. Age (≥13), weight (≥40 kg), GPI-AP deficiency percentage, flow cytometry confirmation, clinical manifestation type, and complement inhibitor exclusion. Every field needs a source document. Missing one criterion means a denial on J1307. |
| 3 | Flag any member receiving both J1307 and J1299 or J1303. Run a report in your billing system. Any overlap — crovalimab-akkz with eculizumab or ravulizumab-cwvz — violates the combination therapy exclusion. Resolve the clinical situation before billing. If the prescriber is mid-transition between drugs, document the exact stop date for the prior complement inhibitor. |
| 4 | Confirm your infusion site meets the Site of Care policy. Aetna's Site of Care Utilization Management Policy applies here. Before you bill CPT 96413 (the primary chemotherapy infusion code) or 96414 and 96415 (for additional hours), verify that the infusion location is covered. This is a separate Aetna policy — don't assume approval for the drug means approval for the site. |
| 5 | Set up a reauthorization calendar with LDH and hemoglobin triggers. Continuation approval requires documented positive response. That means you need lab values — not just a prescriber note saying "patient doing well." Build a workflow that flags upcoming reauth windows and automatically pulls the relevant labs into the chart for review. |
| 6 | Separate the commercial and Medicare pathways. CPB 1064 applies to commercial plans only. For Medicare members, Aetna directs you to its Medicare Part B criteria. Don't apply these billing guidelines to Medicare claims — the criteria differ, and mixing them up is how you generate unnecessary denials. |
| 7 | If you're transitioning patients from Soliris or Ultomiris, loop in your compliance officer. The combination therapy exclusion is strict, and the transition timing has financial exposure. Your compliance officer needs to know the stop date, the start date, and how the authorization was documented. If there's any ambiguity about overlapping therapy, get that resolved before the claim goes out. |
| 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 Crovalimab-akkz (PiaSky) Under CPB 1064
Covered HCPCS Code (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J1307 | HCPCS | Injection, crovalimab-akkz, 10 mg |
Administration CPT Codes (Related to CPB 1064)
| Code | Type | Description |
|---|---|---|
| 96401 | CPT | Chemotherapy administration, subcutaneous or intramuscular; non-hormonal antineoplastic |
| 96402 | CPT | Chemotherapy administration, subcutaneous or intramuscular; hormonal antineoplastic |
| 96413 | CPT | Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug |
| 96414 | CPT | Chemotherapy administration, intravenous infusion technique; each additional hour |
| 96415 | CPT | Chemotherapy administration, intravenous infusion technique; each additional sequential infusion |
Contextual HCPCS Codes (Related Complement Inhibitors)
These codes appear in the policy because eculizumab and ravulizumab-cwvz are the drugs excluded from concurrent use with crovalimab-akkz. They are not covered under CPB 1064 for this indication.
| Code | Type | Description | Note |
|---|---|---|---|
| J1299 | HCPCS | Injection, eculizumab, 2 mg | Related to CPB 0807; not to be billed concurrently with J1307 |
| J1303 | HCPCS | Injection, ravulizumab-cwvz, 10 mg | Related to CPB 0946; not to be billed concurrently with J1307 |
Key ICD-10-CM Diagnosis Code
| Code | Description |
|---|---|
| D59.5 | Paroxysmal nocturnal hemoglobinuria [Marchiafava-Micheli] |
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