Aetna modified CPB 0904 for daratumumab (Darzalex) and daratumumab/hyaluronidase-fihj (Darzalex Faspro), effective March 3, 2026. Here's what billing teams need to know.
Aetna, a CVS Health company, updated its daratumumab coverage policy under CPB 0904 on March 3, 2026. The revision expands and refines medical necessity criteria across multiple myeloma indications, light chain amyloidosis, and other hematologic conditions. The primary billing codes affected are J9145 (daratumumab IV, 10 mg) and J9144 (daratumumab/hyaluronidase-fihj SC, 10 mg), along with a broad set of combination-agent HCPCS codes and CPT codes 96413–96416 for intravenous chemotherapy administration. If your practice bills daratumumab for any myeloma patient on an Aetna commercial plan, this update changes what you need to document before claims go out the door.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Daratumumab (Darzalex) and Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) |
| Policy Code | CPB 0904 |
| Change Type | Modified |
| Effective Date | March 3, 2026 |
| Impact Level | High |
| Specialties Affected | Hematology/Oncology, Medical Oncology, Infusion Centers, Specialty Pharmacy |
| Key Action | Audit active daratumumab precertifications against updated combination-regimen criteria before billing new claims |
Aetna Daratumumab Coverage Criteria and Medical Necessity Requirements 2026
Aetna's daratumumab coverage policy under CPB 0904 requires precertification for all participating providers and members on applicable commercial plan designs. Call (866) 752-7021 or fax (888) 267-3277 to initiate prior authorization. This is not optional — there is no pathway to skip precertification on Aetna commercial plans for J9144 or J9145.
The coverage policy organizes medical necessity criteria by line of therapy and transplant eligibility. That structure matters for billing because a claim with the right diagnosis code but the wrong combination regimen will still deny. Your documentation needs to match the specific criteria bucket Aetna uses, not just the diagnosis.
Multiple Myeloma — Primary (First-Line) Therapy
Aetna covers daratumumab as primary therapy for multiple myeloma under several distinct scenarios. The member must meet one of the following:
| # | Covered Indication |
|---|---|
| 1 | Asymptomatic high-risk smoldering disease — covered when the member has asymptomatic high-risk smoldering disease. |
| 2 | Transplant-ineligible or transplant-deferred — covered in combination with lenalidomide and dexamethasone. |
| 3 | Transplant-ineligible — covered in combination with bortezomib (J9041), melphalan (J8600/J9245), and prednisone (J7512). |
| 4 | Transplant-eligible — covered with either bortezomib/thalidomide/dexamethasone (max 16 doses) or carfilzomib (J9047)/lenalidomide/dexamethasone. |
| 5 | Any transplant status — covered with bortezomib, lenalidomide, and dexamethasone (Darzalex Faspro capped at 16 doses in this regimen). |
The 16-dose cap on Darzalex Faspro in certain regimens is the kind of detail that causes mid-course denials. Track dose counts in your charge capture from day one.
Multiple Myeloma — Previously Treated
For previously treated myeloma, the policy links coverage to prior therapy exposure and refractory status. Aetna covers daratumumab (J9144 or J9145) in combination with:
| # | Covered Indication |
|---|---|
| 1 | Lenalidomide and dexamethasone — for bortezomib-refractory members |
| 2 | Bortezomib and dexamethasone — for lenalidomide-refractory members |
| 3 | Carfilzomib and dexamethasone — for bortezomib-refractory or lenalidomide-refractory members |
| 4 | Carfilzomib, pomalidomide, and dexamethasone — no refractory qualifier required |
| 5 | Pomalidomide and dexamethasone — requires at least one prior therapy including a proteasome inhibitor (PI) and an immunomodulatory agent |
| 6 | Selinexor and dexamethasone |
| 7 | Venetoclax and dexamethasone — only for members with documented t(11;14) translocation |
| 8 | Single-agent daratumumab — requires at least three prior therapies including a PI and an immunomodulatory agent, OR double refractory to a PI and an immunomodulatory agent |
The venetoclax combination is the one most likely to generate claim denials without proper lab documentation. Aetna will want proof of the t(11;14) translocation on file before approving J9144 or J9145 in that regimen. Make sure your oncology team has FISH or cytogenetics results in the record before you submit the precertification.
Maintenance Therapy
Aetna covers daratumumab for maintenance therapy in symptomatic multiple myeloma for transplant candidates. The policy specifies criteria for post-transplant maintenance — document transplant history and the current maintenance regimen in every authorization request.
Other Hematologic Indications
CPB 0904 extends coverage beyond multiple myeloma. The ICD-10 code set in this policy — 317 codes in total — includes nasopharyngeal malignancies, gastric cancers, colon cancers, pancreatic cancers, and a wide range of hematologic malignancies. That breadth suggests Aetna is tracking off-label and investigational use aggressively. If you're billing J9144 or J9145 with a diagnosis outside the core myeloma codes, verify it maps to a covered indication in CPB 0904 before the claim goes out.
Aetna Daratumumab Exclusions and Non-Covered Indications
The policy does not cover daratumumab for indications where the clinical evidence is considered insufficient by Aetna. Combination regimens not listed in the covered criteria above are not covered by default. A regimen that seems clinically similar to a covered one is not a covered one — Aetna adjudicates against the specific combination, not the drug class.
The real financial exposure here is off-label use without documented prior authorization. If a physician is using daratumumab in a regimen not listed in CPB 0904 — even if it appears in NCCN guidelines — expect a denial unless the authorization explicitly approved that regimen. Off-label coverage under Aetna commercial plans requires a separate review process.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| MM — high-risk smoldering (asymptomatic) | Covered | J9144, J9145 | Prior auth required |
| MM — transplant-ineligible, dara + len/dex | Covered | J9144, J9145, J1100, J8540 | Prior auth required |
| MM — transplant-ineligible, dara + bort/mel/pred | Covered | J9144, J9145, J9041, J8600, J7512 | Prior auth required |
| MM — transplant-eligible, dara + bort/thal/dex | Covered | J9144, J9145, J9041, J1100 | Max 16 doses; prior auth required |
| MM — transplant-eligible, dara + carfilzomib/len/dex | Covered | J9144, J9145, J9047 | Prior auth required |
| MM — any transplant, dara + bort/len/dex | Covered | J9144, J9145, J9041 | Darzalex Faspro max 16 doses |
| MM — previously treated, bortezomib-refractory, dara + len/dex | Covered | J9144, J9145 | Bortezomib-refractory required |
| MM — previously treated, lenalidomide-refractory, dara + bort/dex | Covered | J9144, J9145, J9041 | Lenalidomide-refractory required |
| MM — previously treated, dara + carfilzomib/dex | Covered | J9144, J9145, J9047 | Bortezomib- or lenalidomide-refractory |
| MM — previously treated, dara + carfilzomib/pom/dex | Covered | J9144, J9145, J9047 | No refractory qualifier |
| MM — previously treated, dara + pom/dex | Covered | J9144, J9145 | ≥1 prior PI + immunomodulatory agent |
| MM — previously treated, dara + selinexor/dex | Covered | J9144, J9145 | Prior auth required |
| MM — previously treated, dara + venetoclax/dex | Covered | J9144, J9145 | Requires documented t(11;14) translocation |
| MM — single agent, ≥3 prior therapies | Covered | J9144, J9145 | Must include prior PI + immunomodulatory agent |
| MM — single agent, double refractory | Covered | J9144, J9145 | Double refractory to PI + immunomodulatory agent |
| MM — maintenance, post-transplant | Covered | J9144, J9145 | Transplant history required in auth |
| Combination with cyclophosphamide/bortezomib/dex | Covered | J9144, J9145, J9070, J9041 | Prior auth required |
| Off-label indications not in CPB 0904 | Not Covered (standard) | — | Separate review required |
| Regimens not specified in CPB 0904 | Not Covered | — | Even if NCCN-listed |
Aetna Daratumumab Billing Guidelines and Action Items 2026
The effective date of March 3, 2026 means these criteria are already in force. If your team has authorizations approved under the prior version of CPB 0904, check whether the approved regimen still maps cleanly to the updated criteria.
| # | Action Item |
|---|---|
| 1 | Audit active daratumumab precertifications immediately. Pull every open auth for J9144 and J9145 on Aetna commercial plans. Confirm the approved regimen matches a covered indication in the updated CPB 0904. If the regimen is close but not exact, call Aetna at (866) 752-7021 before the next infusion. |
| 2 | Add t(11;14) translocation documentation to your venetoclax combination workflow. Claims for daratumumab plus venetoclax plus dexamethasone will deny without proof of t(11;14). FISH or cytogenetics results must be in the authorization file before you submit. Build this into your precertification checklist now. |
| 3 | Track Darzalex Faspro dose counts for capped regimens. Two regimens cap Darzalex Faspro at 16 doses: bortezomib/thalidomide/dexamethasone and bortezomib/lenalidomide/dexamethasone. Set a dose counter in your charge capture or EHR for every patient on these regimens. A claim for dose 17 will deny, and a retro-auth is unlikely. |
| 4 | Document refractory status explicitly in every prior authorization request. Many previously-treated myeloma criteria require the member to be bortezomib-refractory or lenalidomide-refractory. Aetna reviewers will look for this language. "Previously treated" is not sufficient — you need "refractory to [agent]" in the clinical notes and the auth request. |
| 5 | Confirm ICD-10 codes map to a covered indication before billing. The policy includes 317 ICD-10 codes, which creates real claim denial risk if your team selects a diagnosis that looks correct but falls into a non-covered bucket. Run your primary diagnosis against the CPB 0904 code list before billing J9144 or J9145. |
| 6 | Verify combination-agent HCPCS codes are on the claim. Aetna adjudicates daratumumab coverage partly based on the combination regimen. If you're billing J9144 or J9145 alone when the approved regimen includes bortezomib (J9041, J9046, J9048, J9049, J9051, or J9054) or carfilzomib (J9047) or melphalan (J9245, J9246), include the combination agents on the claim or in the auth documentation. Missing combination codes can flag a mismatch between the auth and the claim. |
| 7 | Use the correct IV administration codes. CPB 0904 lists CPT codes 96413, 96414, 96415, and 96416 for intravenous chemotherapy administration. These codes support reimbursement for the administration itself. Confirm your charge capture templates include the appropriate codes from this set for daratumumab IV infusions. For questions about which specific administration codes apply to your infusion workflow, consult your billing consultant or coding resource — CPB 0904 lists all four codes under intravenous chemotherapy administration without further specification. |
If your patient population includes significant myeloma volume or you're managing complex multi-drug regimens under this policy, loop in your compliance officer before submitting claims under the updated CPB 0904. The refractory-status documentation requirements and dose caps create multiple claim denial pressure points that are worth a formal internal review.
| 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 Daratumumab Under CPB 0904
Primary HCPCS Codes (Covered When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J9144 | HCPCS | Injection, daratumumab 10 mg and hyaluronidase-fihj (Darzalex Faspro, subcutaneous) |
| J9145 | HCPCS | Injection, daratumumab, 10 mg (Darzalex, intravenous) |
Combination-Agent HCPCS Codes (Covered When Part of an Approved Regimen)
| Code | Type | Description |
|---|---|---|
| J1100 | HCPCS | Injection, dexamethasone sodium phosphate, 1 mg |
| J7512 | HCPCS | Prednisone, immediate release or delayed release, oral, 1 mg |
| J8530 | HCPCS | Cyclophosphamide, oral, 25 mg |
| J8540 | HCPCS | Dexamethasone, oral, 0.25 mg |
| J8541 | HCPCS | Dexamethasone (Hemady), oral, 0.25 mg |
| J8600 | HCPCS | Melphalan, oral, 2 mg |
| J9041 | HCPCS | Injection, bortezomib, 0.1 mg |
| J9046 | HCPCS | Injection, bortezomib (Dr. Reddy's), not therapeutically equivalent to J9041, 0.1 mg |
| J9047 | HCPCS | Injection, carfilzomib, 1 mg |
| J9048 | HCPCS | Injection, bortezomib (Fresenius Kabi), not therapeutically equivalent to J9041, 0.1 mg |
| J9049 | HCPCS | Injection, bortezomib (Hospira), not therapeutically equivalent to J9041, 0.1 mg |
| J9051 | HCPCS | Injection, bortezomib (Maia), not therapeutically equivalent to J9041, 0.1 mg |
| J9054 | HCPCS | Injection, bortezomib (Boruzu), 0.1 mg |
| J9070 | HCPCS | Cyclophosphamide, 100 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 |
| J9176 | HCPCS | Injection, elotuzumab, 1 mg |
| J9245 | HCPCS | Injection, melphalan hydrochloride, 50 mg |
| J9246 | HCPCS | Injection, melphalan (Evomela), 1 mg |
| J9248 | HCPCS | Injection, melphalan (Hepzato), 1 mg |
| J9249 | HCPCS | Injection, melphalan (Apotex), 1 mg |
| J9301 | HCPCS | Injection, obinutuzumab, 10 mg |
| J9311 | HCPCS | Injection, rituximab 10 mg and hyaluronidase |
| J9312 | HCPCS | Injection, rituximab, 10 mg |
CPT Codes for Administration and Related Procedures
| Code | Type | Description |
|---|---|---|
| 96413 | CPT | Intravenous chemotherapy administration |
| 96414 | CPT | Intravenous chemotherapy administration |
| 96415 | CPT | Intravenous chemotherapy administration |
| 96416 | CPT | Intravenous chemotherapy administration |
| 38206 | CPT | Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous |
| 38241 | CPT | Hematopoietic progenitor cell (HPC); autologous transplantation |
Key ICD-10-CM Diagnosis Codes
The policy references 317 ICD-10 codes. The sample below reflects codes present in the policy data. Confirm your full diagnosis list against the complete CPB 0904 code set.
| Code | Description |
|---|---|
| C11.0–C11.9 | Malignant neoplasm of nasopharynx |
| C16.0–C16.9 | Malignant neoplasm of stomach |
| C18.0–C18.9 | Malignant neoplasm of colon |
| C21.0–C21.8 | Malignant neoplasm of anus and anal canal |
| C25.0–C25.6 | Malignant neoplasm of pancreas |
The full 317-code ICD-10 list is available in the complete CPB 0904 document. Review the full policy at PayerPolicy for the complete diagnosis code set before updating your charge capture or superbills.
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