Aetna modified CPB 1089 for linvoseltamab-gcpt (Lynozyfic), effective December 4, 2025. Here's what billing teams need to do.
Aetna updated its linvoseltamab-gcpt (Lynozyfic) coverage policy under CPB 1089 with a December 4, 2025 effective date. This drug is indicated for relapsed or refractory multiple myeloma. (Note: the BCMA/CD3 mechanism of action description is pharmacological background — it's not sourced from CPB 1089.) The policy governs precertification requirements and medical necessity criteria for commercial plans, with administration billed under CPT 96413, 96414, and 96415, and the drug itself not yet assigned a dedicated J-code — a billing wrinkle your team needs to address now.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna |
| Policy | Linvoseltamab-gcpt (Lynozyfic) — CPB 1089 |
| Policy Code | CPB 1089 |
| Change Type | Modified |
| Effective Date | December 4, 2025 |
| Impact Level | High |
| Specialties Affected | Hematology, Oncology, Infusion Centers |
| Key Action | Confirm prior authorization and document all four prior therapy categories before submitting claims for C90.00 or C90.02 |
Aetna Linvoseltamab-gcpt Coverage Criteria and Medical Necessity Requirements 2025
The Aetna linvoseltamab-gcpt coverage policy under CPB 1089 sets a high bar. Aetna considers Lynozyfic medically necessary for relapsed or refractory multiple myeloma only when the patient has received at least four prior therapies. Those therapies must span three specific drug categories — and all three must be documented.
The three required prior therapy categories are:
| # | Covered Indication |
|---|---|
| 1 | A proteasome inhibitor — bortezomib (J9041, J9046, J9048, J9049, J9051, J9054), ixazomib, or carfilzomib (J9047) |
| 2 | An immunomodulatory agent — lenalidomide, pomalidomide, or thalidomide |
| 3 | An anti-CD38 monoclonal antibody — daratumumab (J9144, J9145) or isatuximab (J9227) |
All three categories must be represented in the treatment history. Four prior lines total, at minimum. Miss one category and the claim fails medical necessity review.
This is a triple-class exposed (TCE) definition, which aligns with FDA labeling for Lynozyfic. That alignment is helpful — it means you can use the same prior authorization documentation package you'd build for other late-line myeloma agents like teclistamab or elranatamab. If your practice already treats heavily pretreated myeloma patients, this framework is familiar.
Prior authorization is mandatory. Precertification of linvoseltamab-gcpt 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.
Do not administer this drug without confirmed prior auth. The reimbursement risk on a drug at this price point is too high to leave to retroactive appeals.
Aetna Linvoseltamab-gcpt Continuation of Therapy Criteria 2025
Continuation approval is more straightforward than initial approval, but it's not automatic. Aetna considers continuation therapy medically necessary when the member is requesting reauthorization for multiple myeloma and shows no evidence of unacceptable toxicity or disease progression on the current regimen.
Two conditions, both must be true: no unacceptable toxicity, and no disease progression. Your reauthorization documentation needs to address both points directly. A progress note that says "patient is tolerating therapy well and responding" is not the same as documentation that explicitly states no evidence of progression on current imaging or labs.
Build a reauthorization template that captures both criteria by name. Reviewers are checking for those specific terms.
Aetna Linvoseltamab-gcpt Exclusions and Non-Covered Indications
Aetna considers all indications for linvoseltamab-gcpt other than relapsed or refractory multiple myeloma — as defined in the initial approval criteria — experimental, investigational, or unproven.
This means any off-label use gets denied. That includes earlier lines of therapy in multiple myeloma (fewer than four prior lines), other plasma cell dyscrasias, or any hematologic malignancy outside the specific C90.00/C90.02 ICD-10 coding. If a physician wants to use Lynozyfic in a patient with three prior lines, that's a denial waiting to happen under this coverage policy.
This policy does not appear to address scenarios where a patient could not tolerate or access a required prior therapy class. If you're facing that scenario, consult your compliance officer before submission — and consider a peer-to-peer before the claim goes in.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Relapsed/refractory multiple myeloma, ≥4 prior therapies including proteasome inhibitor, IMiD, and anti-CD38 antibody | Covered | C90.00, C90.02 | Prior authorization required; prior therapy documentation mandatory |
| Relapsed/refractory multiple myeloma, fewer than 4 prior therapies | Not Covered | C90.00, C90.02 | Does not meet medical necessity threshold |
| Multiple myeloma — continuation of therapy, no progression, no unacceptable toxicity | Covered (Reauthorization) | C90.00, C90.02 | Reauth must document absence of progression and toxicity explicitly |
| All other indications (any malignancy or condition not listed above) | Experimental / Not Covered | — | Policy considers all other uses investigational |
Aetna Linvoseltamab-gcpt Billing Guidelines and Action Items 2025
These are the steps your billing team needs to take before — and after — the December 4, 2025 effective date.
| # | Action Item |
|---|---|
| 1 | Confirm prior authorization before every infusion. Call (866) 752-7021 or fax (888) 267-3277. No auth, no claim. The cost of Lynozyfic makes an unauthorized claim a significant write-off exposure. |
| 2 | Document all four prior therapy lines — by category. Your clinical documentation needs to show at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody. Code the prior therapies using their HCPCS codes where applicable: J9041/J9046/J9047/J9048/J9049/J9051/J9054 for proteasome inhibitors, J9144/J9145 or J9227 for anti-CD38 agents. Payers pull prior claims data — but don't rely on that alone. Get the documentation in the chart. |
| 3 | Bill infusion administration under CPT 96413, 96414, and 96415. CPT 96413 covers the initial hour of chemotherapy infusion. CPT 96414 is each additional sequential infusion of a new substance or drug, up to one hour. CPT 96415 is each additional hour of the same drug. Map your infusion encounter correctly — don't default to 96413 for all hours. |
| 4 | Use ICD-10 C90.00 or C90.02 on every claim. C90.00 is multiple myeloma without mention of remission. C90.02 is multiple myeloma in relapse. For relapsed or refractory patients, C90.02 is usually correct. Confirm with your coder — the distinction matters for medical necessity alignment. |
| 5 | Build a reauthorization workflow now. Continuation therapy requires evidence of no progression and no unacceptable toxicity. Set a calendar trigger at your auth expiration date and assign a specific staff member to pull the progress note documentation. Don't chase this at the last minute. |
| 6 | Watch for a dedicated J-code for linvoseltamab-gcpt. As of this policy update, Lynozyfic does not have a specific HCPCS J-code listed in CPB 1089. Billing without a product-specific code creates audit exposure. Check CMS quarterly HCPCS updates and Aetna's reimbursement fee schedules for a new code assignment. When one publishes, update your charge capture immediately. |
| 7 | Flag off-label requests before they reach the claim stage. If a provider wants to use Lynozyfic in fewer than four prior lines or for a non-myeloma diagnosis, that's a denial under this policy. Catch it in precertification, not post-service. Your billing team should not be the first to discover an off-label intent. |
| 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 Linvoseltamab-gcpt (Lynozyfic) Under CPB 1089
Covered CPT Codes — Infusion Administration
| Code | Type | Description |
|---|---|---|
| 96413 | CPT | Chemotherapy administration, intravenous infusion technique; up to one hour, single or initial substance/drug |
| 96414 | CPT | Chemotherapy administration, intravenous infusion technique; each additional sequential infusion of a new substance/drug, up to 1 hour |
| 96415 | CPT | Chemotherapy administration, intravenous infusion technique; each additional hour |
HCPCS Codes — Prior Therapy Documentation Reference
These codes represent the drug classes required as prior therapy to establish medical necessity. They appear in CPB 1089 and are relevant to prior auth documentation and prior claims verification.
| Code | Type | Description |
|---|---|---|
| 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 |
| J9144 | HCPCS | Injection, daratumumab and hyaluronidase-fihj, 10 mg |
| J9145 | HCPCS | Injection, daratumumab, 10 mg |
| J9227 | HCPCS | Injection, isatuximab-irfc, 10 mg |
Key ICD-10-CM Diagnosis Codes
| Code | Description |
|---|---|
| C90.00 | Multiple myeloma not having achieved remission |
| C90.02 | Multiple myeloma in relapse |
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