Aetna modified CPB 0949 governing caplacizumab-yhdp (Cablivi) coverage for acquired thrombotic thrombocytopenic purpura (aTTP), effective December 4, 2025. Here's what billing teams need to know before submitting claims under HCPCS C9047.
Aetna, a CVS Health company, updated this coverage policy with tightened continuation-of-therapy criteria and explicit recurrence limits. The policy governs HCPCS code C9047 (injection, caplacizumab-yhdp, 1 mg) and a range of administration codes including CPT 96365–96368, 96372, and the chemotherapy administration codes 96401, 96409, 96410, 96411, 96413, 96414, 96415, 96416, and 96417. If your facility or specialty pharmacy bills Cablivi for aTTP patients, this update directly affects your precertification process and your risk of claim denial.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Caplacizumab-yhdp (Cablivi) — CPB 0949 |
| Policy Code | CPB 0949 Aetna |
| Change Type | Modified |
| Effective Date | December 4, 2025 |
| Impact Level | High |
| Specialties Affected | Hematology, hospital inpatient billing, specialty pharmacy, infusion services |
| Key Action | Audit active Cablivi authorizations now — confirm ADAMTS13 lab documentation and recurrence counts before December 4, 2025 |
Aetna Caplacizumab Coverage Criteria and Medical Necessity Requirements 2025
The Aetna caplacizumab-yhdp coverage policy breaks into two distinct gates: initial approval and continuation of therapy. Get either wrong and you're looking at a claim denial that's very hard to overturn without lab documentation you should have collected during treatment.
Initial Approval — aTTP
Aetna considers caplacizumab-yhdp medically necessary for aTTP when all four of the following criteria are met:
| # | Covered Indication |
|---|---|
| 1 | The member received Cablivi with plasma exchange — concurrent use is required, not sequential. |
| 2 | The medication will be given in combination with immunosuppressive therapy. |
| 3 | Treatment will not extend beyond 30 days from cessation of plasma exchange — unless persistent aTTP is documented. |
| 4 | The member has not had more than two aTTP recurrences while on Cablivi. A recurrence means the member needed to reinitiate plasma exchange. A 28-day therapy extension does not count as a recurrence. |
That fourth criterion is the one billing teams miss. The policy defines "recurrence" specifically — reinitiation of plasma exchange — and explicitly excludes therapy extensions from that count. Document this distinction in your prior authorization requests. Conflating a 28-day extension with a recurrence is a fast path to denial.
Prior authorization is required for all Aetna participating providers and members in applicable plan designs. Call (866) 752-7021 or fax (888) 267-3277. Statement of Medical Necessity forms are available through Aetna's Specialty Pharmacy Precertification portal.
Continuation of Therapy — aTTP
The continuation criteria are where this update gets more demanding. Aetna considers continuation medically necessary only when all of the following are met:
| # | Covered Indication |
|---|---|
| 1 | The request covers extension of therapy after the initial course — meaning the member completed the treatment period during and 30 days after plasma exchange. |
| 2 | The member shows documented signs of persistent underlying aTTP via either:
|
| 3 | All three of the following together: microangiopathic hemolytic anemia (MAHA) confirmed by schistocytes on peripheral smear, thrombocytopenia (platelet count below the lab reference range), and elevated lactate dehydrogenase (LDH above the lab reference range). |
The real issue here is criterion 2. You need either the ADAMTS13 result below 10% or all three components of the MAHA triad — these are two separate qualifying pathways. Aetna will expect to see lab values in the record. If your clinical team is pulling ADAMTS13 assays, make sure results are documented with reference ranges. Aetna's related policy CPB 0780 covers ADAMTS13 testing — that's worth checking before your next authorization.
Build both pathways into your prior auth workflow. Either one qualifies independently — the member does not need to fail one to use the other.
Aetna Caplacizumab Exclusions and Non-Covered Indications
Aetna is direct on this point: all indications outside aTTP are experimental, investigational, or unproven. There is no coverage for off-label Cablivi use under this coverage policy.
If your team has seen any requests for caplacizumab in conditions other than acquired TTP — including hereditary TTP or other thrombotic microangiopathies pursued off-label — stop those claims now. Billing HCPCS C9047 for non-aTTP indications will result in denial with no clear appeal path under CPB 0949.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| aTTP — initial treatment with plasma exchange + immunosuppression | Covered | C9047, M31.10–M31.19, D69.3 | Prior auth required; max 30 days post-plasma exchange cessation; ≤2 recurrences |
| aTTP — continuation of therapy with ADAMTS13 <10% | Covered | C9047, M31.10–M31.19 | One 28-day extension per treatment course; ≤2 recurrences; immunosuppression required |
| aTTP — continuation via MAHA triad (schistocytes + thrombocytopenia + elevated LDH) | Covered | C9047, M31.10–M31.19 | All three MAHA criteria must be met; ADAMTS13 not required if triad is complete |
| All other indications | Not Covered | — | Considered experimental, investigational, or unproven |
| aTTP with >2 recurrences on Cablivi | Not Covered | — | Coverage stops at the third recurrence |
| Second 28-day extension after initial course | Not Covered | — | Policy allows only one 28-day continuation extension per treatment episode |
Aetna Caplacizumab Billing Guidelines and Action Items 2025
The effective date is December 4, 2025. That's your deadline for getting authorizations aligned with the updated criteria.
| # | Action Item |
|---|---|
| 1 | Audit all active Cablivi authorizations before December 4, 2025. Pull every open auth for HCPCS C9047 and confirm whether each patient is in the initial phase or the continuation phase. Flag any auth that might cross the December 4 date without updated documentation. |
| 2 | Verify recurrence counts in the patient record. Aetna caps reimbursement at two recurrences. If a patient is approaching that limit, document clearly — and make sure your clinical team understands that a 28-day extension is not a recurrence under this policy. Miscounting will cause a denial. |
| 3 | Collect lab documentation before submitting continuation auths. For ADAMTS13 pathway claims: get the actual activity level with the lab reference range. For the MAHA triad: get the peripheral smear report showing schistocytes, the platelet count with reference range, and the LDH level with reference range. All three must be present and below/above normal. Missing any one component of the MAHA triad means you'll need to qualify via the ADAMTS13 pathway instead — and if that documentation is also unavailable, the continuation auth will be denied. |
| 4 | Update your charge capture to pair C9047 with the correct ICD-10 codes. The covered diagnosis codes under CPB 0949 are D69.3 and M31.10 through M31.19. Map each claim to the specific M31 subcode that matches the clinical encounter. A generic or mismatched ICD-10 will trigger a medical necessity review. |
| 5 | Confirm immunosuppressive therapy is documented and billed alongside Cablivi. Aetna requires combination therapy — Cablivi alone, without concurrent immunosuppression, does not meet medical necessity criteria. Make sure your claims reflect the combination, and that the treatment record documents both. |
| 6 | Update your precertification intake form to capture the plasma exchange cessation date. The 30-day clock on initial therapy runs from that date. Without it documented in your auth request, Aetna has no baseline to evaluate the timeline. |
| 7 | Talk to your compliance officer if you're unsure how this applies to your patient mix. The continuation criteria in particular — especially the MAHA triad vs. ADAMTS13 pathways — can be hard to apply uniformly across a busy hematology or inpatient unit. Get internal alignment before December 4, 2025. |
| 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 Caplacizumab Under CPB 0949
Covered HCPCS Codes (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| C9047 | HCPCS | Injection, caplacizumab-yhdp, 1 mg |
CPT Codes Related to CPB 0949
These codes cover the administration and apheresis services associated with Cablivi billing. Caplacizumab-yhdp billing requires pairing C9047 with the appropriate administration code.
| Code | Type | Description |
|---|---|---|
| 36514 | CPT | Therapeutic apheresis; for plasma pheresis |
| 96365 | CPT | Intravenous infusion administration |
| 96366 | CPT | Intravenous infusion administration |
| 96367 | CPT | Intravenous infusion administration |
| 96368 | CPT | Intravenous infusion administration |
| 96372 | CPT | Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular |
| 96401 | CPT | Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic |
| 96409 | CPT | Chemotherapy administration, intravenous push technique |
| 96410 | CPT | Chemotherapy administration, intravenous push technique |
| 96411 | CPT | Chemotherapy administration, intravenous push technique |
| 96413 | CPT | Chemotherapy administration, intravenous infusion technique |
| 96414 | CPT | Chemotherapy administration, intravenous infusion technique |
| 96415 | CPT | Chemotherapy administration, intravenous infusion technique |
| 96416 | CPT | Chemotherapy administration, intravenous infusion technique |
| 96417 | CPT | Chemotherapy administration, intravenous infusion technique |
Key ICD-10-CM Diagnosis Codes
| Code | Description |
|---|---|
| D69.3 | Immune thrombocytopenic purpura [acquired thrombotic thrombocytopenic purpura (aTTP)] |
| M31.10 | Thrombotic microangiopathy [acquired thrombotic thrombocytopenic purpura (aTTP)] |
| M31.11 | Thrombotic microangiopathy [acquired thrombotic thrombocytopenic purpura (aTTP)] |
| M31.12 | Thrombotic microangiopathy [acquired thrombotic thrombocytopenic purpura (aTTP)] |
| M31.13 | Thrombotic microangiopathy [acquired thrombotic thrombocytopenic purpura (aTTP)] |
| M31.14 | Thrombotic microangiopathy [acquired thrombotic thrombocytopenic purpura (aTTP)] |
| M31.15 | Thrombotic microangiopathy [acquired thrombotic thrombocytopenic purpura (aTTP)] |
| M31.16 | Thrombotic microangiopathy [acquired thrombotic thrombocytopenic purpura (aTTP)] |
| M31.17 | Thrombotic microangiopathy [acquired thrombotic thrombocytopenic purpura (aTTP)] |
| M31.18 | Thrombotic microangiopathy [acquired thrombotic thrombocytopenic purpura (aTTP)] |
| M31.19 | Thrombotic microangiopathy [acquired thrombotic thrombocytopenic purpura (aTTP)] |
One practical note: D69.3 maps to immune thrombocytopenic purpura by default in ICD-10. Confirm your EHR is mapping it correctly for aTTP encounters — some systems code it to the ITP bucket, which can create confusion on audit. The M31.1x family is your cleaner option for aTTP claims, and Aetna lists both, so use the most specific code the clinical documentation supports.
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