Linvoseltamab-gcpt (Lynozyfic) — CPB 1089 | AETNA Coverage Update

TL;DR: Aetna, a CVS Health company, modified CPB 1089 covering linvoseltamab-gcpt (Lynozyfic) for relapsed or refractory multiple myeloma, effective December 4, 2025. Here's what billing teams need to do.

This coverage policy update establishes Aetna's criteria for linvoseltamab-gcpt (Lynozyfic), a bispecific antibody targeting BCMA and CD38. The primary HCPCS code is C9307 (injection, linvoseltamab-gcpt, 1 mg), billed alongside chemotherapy administration codes CPT 96413, 96414, and 96415. If your practice treats heavily pretreated multiple myeloma patients, this policy sets the exact line of therapy and prior treatment requirements that drive approval or denial.

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Quick-Reference Table

Field	Detail Copy
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, Hospital Outpatient
Key Action	Verify four prior therapy lines — including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody — before submitting precertification for C9307

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Aetna Linvoseltamab-gcpt Coverage Criteria and Medical Necessity Requirements 2025

The Aetna linvoseltamab-gcpt coverage policy is narrow by design. Aetna considers Lynozyfic medically necessary for exactly one indication: relapsed or refractory multiple myeloma in patients who have received at least four prior lines of therapy.

That four-line threshold isn't just a number. The policy requires that those prior therapies include at least one agent from each of three specific drug classes. Miss one class, and the claim fails medical necessity review.

The three required prior therapy categories:

#	Covered Indication Copy
1	Proteasome inhibitor — bortezomib (billed as J9041, J9046, J9048, J9049, J9051, or J9054), carfilzomib (J9047), or ixazomib
2	Immunomodulatory agent — lenalidomide, pomalidomide, or thalidomide
3	Anti-CD38 monoclonal antibody — daratumumab (J9144 or J9145) or isatuximab (J9227)

This structure mirrors what you've seen on other late-line myeloma agents — Aetna is aligning with the triple-class exposed framework that FDA and NCCN use for this patient population.

Prior authorization is required for all Aetna participating providers and members in applicable plan designs. Call (866) 752-7021 or fax (888) 267-3277 to initiate precertification. Don't wait until the infusion is scheduled — linvoseltamab-gcpt billing without an approved prior auth is a clean path to claim denial.

Reimbursement flows through HCPCS C9307, billed per 1 mg of linvoseltamab-gcpt administered. Pair that with the appropriate chemotherapy administration code: CPT 96413 for the initial hour, 96415 for each additional hour, and 96414 for concurrent infusion. Get your charge capture set up to link these codes correctly before December 4, 2025.

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Aetna Linvoseltamab-gcpt Exclusions and Non-Covered Indications

Aetna is direct here. All indications other than relapsed or refractory multiple myeloma in the qualifying patient population are considered experimental, investigational, or unproven.

That's a broad exclusion that covers any off-label use. If a provider submits a claim for an early-line multiple myeloma patient — or any other cancer type — expect a denial. There's no carve-out for compassionate use or clinical trial scenarios in this commercial policy. For Medicare criteria, Aetna points providers to its separate Medicare Part B step therapy requirements, which are outside the scope of CPB 1089.

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Coverage Indications at a Glance

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Aetna Lynozyfic Billing Guidelines and Action Items 2025

Linvoseltamab-gcpt billing requires clean documentation before the claim ever touches a payer system. Here's what to do before December 4, 2025.

Copy Action Items

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CPT, HCPCS, and ICD-10 Codes for Linvoseltamab-gcpt Under CPB 1089

Covered HCPCS Codes (When Selection Criteria Are Met)

Code	Type	Description Copy
C9307	HCPCS	Injection, linvoseltamab-gcpt, 1 mg

Other HCPCS Codes Related to CPB 1089

These codes represent prior therapies that must be documented to establish medical necessity. They are not billed for Lynozyfic itself but are part of the prior treatment history the policy requires.

Chemotherapy Administration CPT Codes

Code	Type	Description Copy
96413	CPT	Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug
96414	CPT	Chemotherapy administration, intravenous infusion technique; concurrent infusion
96415	CPT	Chemotherapy administration, intravenous infusion technique; each additional hour

Key ICD-10-CM Diagnosis Codes

Code	Description Copy
C90.00	Multiple myeloma not having achieved remission
C90.02	Multiple myeloma in relapse

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The Real Issue With This Policy

The four-line threshold is the gating factor. Most patients reaching Lynozyfic will have the treatment history to qualify — that's the nature of the relapsed/refractory population this drug was approved for. But the documentation burden is real.

You need to show specific agents from three distinct classes, not just a count of prior regimens. A patient who received four bortezomib-based regimens without an anti-CD38 antibody doesn't qualify. Your precertification submission has to name names — specific drugs, not just drug classes.

The continuation criteria are cleaner. No unacceptable toxicity, no disease progression. Keep updated oncology notes in the chart with each cycle. If your reauthorization hits a denial, the appeal will turn entirely on what the treating physician documented about response and tolerability.

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