Aetna modified CPB 0867 for clofarabine (Clolar), effective January 5, 2026. Here's what billing teams need to know about coverage criteria, affected codes, and claim documentation.
Aetna, a CVS Health company, updated its clofarabine coverage policy under CPB 0867 in the Aetna system, expanding the approved indications list across AML, ALL, pediatric ALL, Langerhans cell histiocytosis, and hematopoietic cell transplantation conditioning. The primary code at stake is J9027 (injection, clofarabine, 1 mg), billed alongside CPT 96413 and +96415 for IV infusion administration. If your oncology or infusion team bills clofarabine to Aetna, this update broadens what Aetna will cover — and tightens the documentation requirements you need to meet to prove it.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna |
| Policy | Clofarabine (Clolar) — CPB 0867 |
| Policy Code | CPB 0867 |
| Change Type | Modified |
| Effective Date | January 5, 2026 |
| Impact Level | High |
| Specialties Affected | Hematology/Oncology, Pediatric Oncology, Infusion Centers, Bone Marrow Transplant Programs |
| Key Action | Update prior authorization requests and medical necessity documentation to align with the expanded indication list before billing J9027 to Aetna |
Aetna Clofarabine Coverage Criteria and Medical Necessity Requirements 2026
Aetna's clofarabine coverage policy covers five distinct indication categories. Get these wrong and you're looking at a claim denial. Get them right and you've got solid ground for reimbursement.
1. Acute Myeloid Leukemia (AML)
Aetna considers clofarabine medically necessary for relapsed or refractory AML. No specific molecular subtype restrictions apply here. Document the prior treatment history clearly — "relapsed or refractory" is not self-evident on a claim. Your supporting documentation needs to show what failed first.
2. Acute Lymphoblastic Leukemia (ALL) in Adults
This is where the criteria get specific. Aetna covers clofarabine for:
| # | Covered Indication |
|---|---|
| 1 | Philadelphia chromosome-negative B-ALL |
| 2 | Relapsed or refractory T-ALL |
| 3 | Philadelphia chromosome-positive B-ALL that is refractory to tyrosine kinase inhibitors (TKIs) |
For each of these, clofarabine can be used as a single agent or as part of the clofarabine, cyclophosphamide, and etoposide (CCE) regimen. The CCE combination involves J9027 for clofarabine, J9070–J9076 for cyclophosphamide, and J9181 for injectable etoposide (or J8560 for oral etoposide).
If you're billing for Ph+ B-ALL, document TKI refractoriness explicitly. Without that, Aetna will treat the claim as non-covered.
3. Pediatric Acute Lymphoblastic Leukemia
Pediatric ALL has its own coverage track under this policy. Aetna covers clofarabine for relapsed or refractory pediatric ALL when:
| # | Covered Indication |
|---|---|
| 1 | The disease is BCR::ABL1-negative B-ALL, or |
| 2 | The disease is BCR::ABL1-positive B-ALL, used in combination with dasatinib or imatinib (billed as S0088 for imatinib) as part of a clofarabine-containing regimen |
The BCR::ABL1 fusion status is a hard documentation requirement here. Pull that molecular pathology report before submitting prior authorization.
4. Langerhans Cell Histiocytosis (LCH)
Aetna considers clofarabine medically necessary for LCH in members 18 years of age or younger. This coverage applies as first-line or subsequent therapy, regardless of mutation status. That "irrespective of mutation" language is meaningful — you don't need BRAF V600E or other mutation documentation to support this indication.
5. Hematopoietic Cell Transplantation Conditioning
This is the most structurally complex part of the updated policy. Aetna covers clofarabine as conditioning for allogenic transplant under two tracks:
| # | Covered Indication |
|---|---|
| 1 | Myeloablative conditioning: clofarabine combined with busulfan (J0594). CPT 38242 covers allogeneic lymphocyte infusions in this context. |
| 2 | Reduced-intensity conditioning: clofarabine combined with busulfan, melphalan with or without thiotepa, total body irradiation, or cyclophosphamide plus total body irradiation with post-transplant cyclophosphamide. |
For reduced-intensity regimens, the melphalan codes include J9245, J9246, and J9249. Thiotepa bills under J9341 or J9342. Make sure the conditioning regimen is fully documented in the prior authorization request — Aetna needs to see the complete combination, not just J9027 in isolation.
Continuation of Therapy
Aetna covers ongoing clofarabine therapy when the member shows no evidence of unacceptable toxicity or disease progression on the current regimen. Your infusion team needs to document response assessments at each treatment milestone. Missing that documentation is one of the fastest routes to a claim denial on continuation claims.
Aetna Clofarabine Exclusions and Non-Covered Indications
Aetna considers all clofarabine uses outside the five covered indications to be experimental, investigational, or unproven. There is no partial coverage or off-label carve-out here.
If your oncologist is using clofarabine for a solid tumor indication — stomach cancer (C16.x), lung cancer (C34.x), or any diagnosis outside the hematologic malignancy categories — Aetna will not cover it under this policy. The ICD-10 codes for stomach and lung malignancies appear in the policy's broader code list, but clofarabine (J9027) is not a covered service for those diagnoses.
The real exposure here is mixed-patient panels. If your infusion center treats both hematologic and solid tumor patients, verify each clofarabine claim against a covered ICD-10 before submission.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| AML — relapsed or refractory | Covered | J9027, CPT 96413, +96415 | Document prior treatment failure |
| ALL — Ph-negative B-ALL | Covered | J9027, CPT 96413, +96415 | Single agent or CCE regimen |
| ALL — relapsed/refractory T-ALL | Covered | J9027, CPT 96413, +96415 | Single agent or CCE regimen |
| ALL — Ph-positive B-ALL, TKI-refractory | Covered | J9027, CPT 96413, +96415 | Must document TKI refractoriness |
| Pediatric ALL — BCR::ABL1-negative B-ALL | Covered | J9027, CPT 96413, +96415 | Include molecular pathology report |
| Pediatric ALL — BCR::ABL1-positive B-ALL + TKI | Covered | J9027, S0088 (imatinib), CPT 96413 | Combination with dasatinib or imatinib required |
| Langerhans cell histiocytosis — age ≤18 | Covered | J9027, CPT 96413, +96415 | First-line or subsequent; no mutation requirement |
| HCT conditioning — myeloablative + busulfan | Covered | J9027, J0594, CPT 38242 | Allogenic transplant only |
| HCT conditioning — reduced-intensity + busulfan | Covered | J9027, J0594, CPT 96413 | Document full regimen |
| HCT conditioning — reduced-intensity + melphalan ± thiotepa | Covered | J9027, J9245/J9246/J9249, J9341/J9342 | Document full combination |
| HCT conditioning — reduced-intensity + TBI | Covered | J9027, CPT 96413 | Document irradiation component |
| HCT conditioning — cyclophosphamide + TBI (post-transplant Cy) | Covered | J9027, J9070–J9076, CPT 96413 | Post-transplant cyclophosphamide required |
| All other indications (solid tumors, off-label uses) | Experimental / Not Covered | — | Denial expected; no off-label pathway under this policy |
Aetna Clofarabine Billing Guidelines and Action Items 2026
The effective date for this update is January 5, 2026. These are the steps your billing team needs to take now.
| # | Action Item |
|---|---|
| 1 | Update your prior authorization templates to match the new indication structure. Each of the five covered indications has distinct clinical criteria. A generic "relapsed/refractory leukemia" PA request will not hold up. Build indication-specific PA templates for AML, adult ALL (with Ph status and TKI history fields), pediatric ALL (with BCR::ABL1 status fields), LCH, and HCT conditioning. |
| 2 | Verify J9027 is mapped to a covered ICD-10 on every claim. Clofarabine billing only gets reimbursement when the diagnosis code supports one of the five covered indications. Build a charge capture crosswalk between J9027 and the covered hematologic ICD-10 codes. Flag any J9027 claim with a solid tumor ICD-10 for manual review before submission. |
| 3 | For CCE regimens, bill all components in the same claim encounter. Aetna expects to see the full regimen reflected. When you bill J9027 for clofarabine, include the appropriate cyclophosphamide code (J9070–J9076) and etoposide code (J9181 for injection or J8560 for oral) in the same encounter. Fragmented billing raises audit flags and invites medical necessity denials. |
| 4 | For HCT conditioning claims, include the full regimen in the prior authorization request. Aetna's coverage policy for conditioning is combination-specific. A PA request that lists only J9027 without identifying the partnered agent (busulfan, melphalan, thiotepa, TBI, or cyclophosphamide) will be denied or returned for more information. Your transplant coordinators and billing team need to align on this documentation workflow before the effective date. |
| 5 | Audit your continuation-of-therapy claims for response documentation. Aetna's continuation criteria require no evidence of unacceptable toxicity or disease progression. That means your clinical documentation must show treatment response assessments at each cycle. If your oncology notes don't reflect this clearly, work with your clinical team to add structured response documentation before the next billing cycle. |
| 6 | If you bill for pediatric ALL, confirm BCR::ABL1 status is in the medical record. This is a hard split in the policy — two different coverage tracks depending on fusion status. Missing or ambiguous molecular pathology documentation is a direct path to a claim denial. Get this into your pre-authorization checklist now. |
| 7 | If this policy applies to a high-volume clofarabine practice, talk to your compliance officer. The multi-indication structure, regimen-specific criteria, and pediatric-versus-adult distinctions create real documentation risk. A compliance review of your current billing patterns against this updated CPB 0867 is worth doing before January 5, 2026. |
| 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 Clofarabine Under CPB 0867
Primary HCPCS Code (Covered When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J9027 | HCPCS | Injection, clofarabine, 1 mg |
CPT Codes Related to Administration
| Code | Type | Description |
|---|---|---|
| 96413 | CPT | Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance |
| +96415 | CPT | Each additional hour (add-on to 96413) |
| 38242 | CPT | Allogeneic lymphocyte infusions |
HCPCS Codes for Combination Regimen Components
| Code | Type | Description |
|---|---|---|
| J0594 | HCPCS | Injection, busulfan, 1 mg |
| J8530 | HCPCS | Cyclophosphamide, oral, 25 mg |
| J8560 | HCPCS | Etoposide, oral, 50 mg |
| J8562 | HCPCS | Fludarabine phosphate, oral, 10 mg |
| J8600 | HCPCS | Melphalan, oral, 2 mg |
| J9033 | HCPCS | Injection, bendamustine HCl (Treanda), 1 mg |
| J9034 | HCPCS | Injection, bendamustine HCl (Bendeka), 1 mg |
| J9036 | HCPCS | Injection, bendamustine hydrochloride (Belrapzo/bendamustine), 1 mg |
| J9039 | HCPCS | Injection, blinatumomab, 1 mcg |
| J9056 | HCPCS | Injection, bendamustine hydrochloride (Vivimusta), 1 mg |
| J9058 | HCPCS | Injection, bendamustine hydrochloride (Apotex), 1 mg |
| J9059 | HCPCS | Injection, bendamustine hydrochloride (Baxter), 1 mg |
| J9070 | HCPCS | Cyclophosphamide, 100 mg |
| J9071 | HCPCS | Injection, cyclophosphamide (Auromedics), 5 mg |
| J9072 | HCPCS | Injection, cyclophosphamide (Dr. Reddy's), 5 mg |
| J9073 | HCPCS | Injection, cyclophosphamide (Ingenus), 5 mg |
| J9074 | HCPCS | Injection, cyclophosphamide (Sandoz), 5 mg |
| J9075 | HCPCS | Injection, cyclophosphamide, not otherwise specified, 5 mg |
| J9076 | HCPCS | Injection, cyclophosphamide (Baxter), 5 mg |
| J9181 | HCPCS | Injection, etoposide, 10 mg |
| J9185 | HCPCS | Injection, fludarabine phosphate, 50 mg |
| J9245 | HCPCS | Injection, melphalan hydrochloride, not otherwise specified, 50 mg |
| J9246 | HCPCS | Injection, melphalan (Evomela), 1 mg |
| J9247 | HCPCS | Injection, melphalan flufenamide, 1 mg |
| J9249 | HCPCS | Injection, melphalan (Apotex), 1 mg |
| J9341 | HCPCS | Injection, thiotepa (Tepylute), 1 mg |
| J9342 | HCPCS | Injection, thiotepa, not otherwise specified, 1 mg |
| S0088 | HCPCS | Imatinib, 100 mg |
Note: Dasatinib has no specific HCPCS code listed in the policy. If your team bills dasatinib for the pediatric BCR::ABL1-positive B-ALL indication, confirm current coding with your compliance officer or billing consultant.
Key ICD-10-CM Diagnosis Codes
The policy includes 326 ICD-10-CM codes. Below are the primary hematologic codes most relevant to covered clofarabine indications. Confirm the full list at CPB 0867 on PayerPolicy.
| Code | Description |
|---|---|
| C16.0–C16.9 | Malignant neoplasm of stomach (listed in policy; not a covered clofarabine indication — flag for review) |
| C34.0–C34.9x | Malignant neoplasm of bronchus and lung (listed in policy; not a covered clofarabine indication — flag for review) |
The full diagnosis code list spans AML, ALL, LCH, and transplant-related diagnoses. Run your ICD-10 mapping against the complete policy code set before finalizing your charge capture crosswalk.
Get the Full Picture for CPT 96413
Track this policy across versions, search 1,500+ policies by CPT code, and get real-time alerts when any payer changes coverage.