Aetna modified CPB 0740 for pralatrexate (Folotyn), effective September 26, 2025. Here's what billing teams need to do.
Aetna, a CVS Health company, updated its pralatrexate coverage policy under CPB 0740 on September 26, 2025. This change defines medical necessity criteria across eight T-cell malignancy indications. The primary billing code affected is HCPCS J9307 (injection, pralatrexate, 1 mg), along with administration codes CPT 96374 and 96375. If your oncology or hematology practice bills Aetna for pralatrexate, audit your prior authorization workflows and ICD-10 coding before claims go out.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Pralatrexate (Folotyn) — CPB 0740 |
| Policy Code | CPB 0740 |
| Change Type | Modified |
| Effective Date | September 26, 2025 |
| Impact Level | High |
| Specialties Affected | Oncology, Hematology, Infusion Therapy |
| Key Action | Confirm each claim maps to a covered indication with the correct single-agent or line-of-therapy criteria before billing J9307 |
Aetna Pralatrexate Coverage Criteria and Medical Necessity Requirements 2025
The Aetna pralatrexate coverage policy under CPB 0740 Aetna system covers eight distinct T-cell malignancy indications. Each one carries its own set of conditions. Getting even one criterion wrong on a prior authorization request or a claim will get you a denial.
Here's the short version: pralatrexate must almost always be used as a single agent. Combination use is only permitted in one indication — subcutaneous panniculitis-like T-cell lymphoma, where Aetna allows pralatrexate combined with prednisone. Every other indication requires single-agent use as a hard condition for medical necessity.
Adult T-Cell Leukemia/Lymphoma (ATLL)
Aetna covers pralatrexate for ATLL when used as a single agent and as subsequent (not first-line) therapy.
Breast Implant-Associated Anaplastic Large Cell Lymphoma (ALCL)
Coverage requires single-agent use and subsequent therapy. First-line use is not covered under this indication.
Cutaneous Anaplastic Large Cell Lymphoma
This is one of the simpler criteria. Single-agent use is the only requirement. Line of therapy is not specified.
Extranodal NK/T-Cell Lymphoma
This indication has the most restrictive criteria. All three of the following must be met:
| # | Covered Indication |
|---|---|
| 1 | Single-agent use |
| 2 | Relapsed or refractory disease |
| 3 | Inadequate response to — or contraindication to — asparaginase-based therapy (e.g., pegaspargase) |
If the member hasn't failed asparaginase-based therapy and doesn't have a documented contraindication, expect a claim denial.
Hepatosplenic T-Cell Lymphoma
Coverage requires single-agent use and at least two prior lines of chemotherapy. Document those prior lines in the record before submitting prior authorization.
Mycosis Fungoides or Sézary Syndrome (MF/SS)
No additional criteria beyond the diagnosis. Single-agent use is not explicitly required here — this is one of the few indications where the policy is less restrictive on use conditions.
Peripheral T-Cell Lymphoma (PTCL)
Aetna covers pralatrexate for PTCL including these subtypes: anaplastic large cell lymphoma, PTCL not otherwise specified (NOS), angioimmunoblastic T-cell lymphoma, enteropathy-associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, nodal peripheral T-cell lymphoma with TFH phenotype, and follicular T-cell lymphoma.
Two conditions apply: single-agent use, and either relapsed/refractory disease or initial palliative therapy.
Subcutaneous Panniculitis-Like T-Cell Lymphoma
The only indication where combination therapy is allowed. Pralatrexate may be used as a single agent or combined with prednisone.
Continuation of Therapy
Aetna considers continuation medically necessary when there's no evidence of unacceptable toxicity or disease progression. Document response to treatment at each assessment. Continued therapy reimbursement depends on that documentation being in the record.
Vitamin B-12 supplementation is medically necessary for all members taking pralatrexate. Bill it separately under CPB 0536. Don't skip this — it's not optional under Aetna's policy.
Aetna Pralatrexate Exclusions and Non-Covered Indications
Aetna's position is explicit: all other indications not listed in Section I are considered experimental, investigational, or unproven. There's no gray area here.
If a physician requests pralatrexate for a solid tumor or a non-T-cell lymphoma — even one with emerging literature — Aetna will deny it under this coverage policy. The ICD-10 code list in CPB 0740 includes codes for nasopharyngeal cancers, esophageal cancers, gastric cancers, lung cancers, breast cancers, ovarian cancers, and melanoma, among others. Those codes appear in the policy as "other CPT codes related to the CPB," not as covered indications.
The real issue here: a claim submitted with a solid tumor diagnosis and J9307 will almost certainly be denied. Make sure your oncology coding team knows which diagnoses Aetna covers before billing pralatrexate.
If you're treating a patient with an off-label indication and believe pralatrexate is medically necessary, talk to your compliance officer and billing consultant before submitting. The gap between "clinically indicated" and "Aetna-covered" is wide on this drug.
Coverage Indications at a Glance
| Indication | Coverage Status | Single-Agent Required | Additional Criteria |
|---|---|---|---|
| Adult T-cell leukemia/lymphoma (ATLL) | Covered | Yes | Subsequent therapy only |
| Breast implant-associated ALCL | Covered | Yes | Subsequent therapy only |
| Cutaneous ALCL | Covered | Yes | None beyond single-agent |
| Extranodal NK/T-cell lymphoma | Covered | Yes | Relapsed/refractory; failed or contraindicated to asparaginase-based therapy |
| Hepatosplenic T-cell lymphoma | Covered | Yes | Two or more prior lines of chemotherapy |
| Mycosis fungoides or Sézary syndrome | Covered | Not specified | None beyond diagnosis |
| Peripheral T-cell lymphoma (PTCL, all listed subtypes) | Covered | Yes | Relapsed/refractory disease or initial palliative therapy |
| Subcutaneous panniculitis-like T-cell lymphoma | Covered | No (prednisone combo allowed) | None beyond diagnosis |
| All other indications | Not Covered / Experimental | — | Denied under CPB 0740 |
Aetna Pralatrexate Billing Guidelines and Action Items 2025
Here's what your billing team needs to do before submitting any pralatrexate claim under the updated CPB 0740 policy.
| # | Action Item |
|---|---|
| 1 | Audit your prior authorization templates against the eight covered indications. Every PA request for J9307 needs to document single-agent use (or prednisone combination for panniculitis), line of therapy, and disease status. Requests that don't address these criteria will come back denied. Update your templates before September 26, 2025. |
| 2 | Confirm ICD-10-CM codes map to a covered T-cell malignancy. Pralatrexate billing with a solid tumor diagnosis code will not pass Aetna's coverage policy. Review the full ICD-10 list in the policy and cross-check against what your oncologists are actually treating. |
| 3 | Bill HCPCS J9307 per 1 mg unit. Pralatrexate is billed per milligram. Dosing is weight-based, so charge capture needs to pull from the actual administered dose, not a flat unit. Underbilling costs you revenue. Overbilling creates audit risk. |
| 4 | Pair J9307 with the correct administration code. Use CPT 96374 for an IV push (single or initial) and CPT 96375 for each additional sequential IV push. If neither applies, CPT 96379 covers unlisted IV or intra-arterial injection or infusion. Don't use an infusion code when the drug is given as a push — that's a billing mismatch that triggers edits. |
| 5 | Bill Vitamin B-12 supplementation separately. Aetna requires it and covers it under CPB 0536. If your team is bundling or skipping the B-12 billing, you're leaving money on the table and potentially creating a clinical documentation gap. |
| 6 | Document line of therapy explicitly in the medical record. For ATLL, breast implant-associated ALCL, PTCL, and hepatosplenic T-cell lymphoma, the number of prior treatment lines is a coverage condition. Vague documentation ("patient has been previously treated") won't hold up on appeal. The record needs to name the prior regimens. |
| 7 | For extranodal NK/T-cell lymphoma claims, document the asparaginase failure or contraindication. This is the most restrictive indication. If the treating physician didn't document why pegaspargase wasn't used — or that the patient failed it — your PA will be denied and your claim won't survive appeal. |
| 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 Pralatrexate Under CPB 0740
Covered HCPCS Code (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J9307 | HCPCS | Injection, pralatrexate, 1 mg |
Key ICD-10-CM Diagnosis Codes
The policy lists 148 ICD-10-CM codes. The T-cell malignancy codes that align directly with the eight covered indications are the ones your billing team needs to verify. The broader code set in the policy includes solid tumor diagnoses that are not covered indications — those codes appear in the policy for reference, not for coverage.
| Code | Description |
|---|---|
| C11.0–C11.9 | Malignant neoplasm of nasopharynx |
| C15.3–C15.9 | Malignant neoplasm of esophagus |
| C16.0–C16.9 | Malignant neoplasm of stomach |
| C18.0–C21.8 | Malignant neoplasm of colon, rectum, rectosigmoid junction, and anus |
| C22.1 | Intrahepatic bile duct carcinoma |
| C23–C24.9 | Malignant neoplasm of gallbladder and biliary tract |
| C25.0–C25.9 | Malignant neoplasm of pancreas |
| C31.0–C31.9 | Malignant neoplasm of accessory sinuses (paranasal) |
| C33–C34.92 | Malignant neoplasm of trachea, bronchus, and lung (NSCLC) |
| C37 | Malignant neoplasm of thymus |
| C38.4 | Malignant neoplasm of pleura |
| C43.0–C44.99 | Melanoma and other malignant neoplasms of skin |
| C45.0 | Mesothelioma of pleura |
| C46.1 | Kaposi's sarcoma of soft tissue |
| C48.1 | Malignant neoplasm of specified parts of peritoneum (primary) |
| C48.2 | Malignant neoplasm of peritoneum, unspecified (primary) |
| C49.0–C49.9 | Malignant neoplasm of other connective and soft tissue |
| C50.011–C50.929 | Malignant neoplasm of breast |
| C53.0–C55 | Malignant neoplasm of cervix uteri and corpus uteri |
| C56.1–C56.3 | Malignant neoplasm of ovary |
The full ICD-10-CM code list in CPB 0740 contains 148 codes. Review the complete list at the Aetna CPB 0740 source document to verify all applicable diagnosis codes before billing.
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