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Epcoritamab-bysp (Epkinly) (CPB 1034, reviewed 2026-10-16)

Aetna·Oncology, Hematology·Medical Policy
Effective date
Not stated
We identified it
Oct 24, 2026
Days to comply
—

Summary

Aetna's Clinical Policy Bulletin 1034 (reviewed 2026-10-16) establishes coverage criteria for epcoritamab-bysp (Epkinly), a bispecific antibody for treating relapsed or refractory B-cell lymphomas. The policy requires precertification for all Aetna participating providers and members, specifies approved treatment combinations and dosing schedules, and limits certain regimens to a maximum of 12 cycles. All other indications remain experimental/investigational.

Action Required

Action needed
Billing team and providers must implement precertification requirement for epcoritamab-bysp (Epkinly) for all Aetna commercial plan members. Before submitting claims with CPT 96401 or HCPCS J9321 for any B-cell lymphoma diagnosis, obtain precertification by calling (866) 752-7021 or faxing (888) 267-3277. Verify that treatment meets one of the specified approval criteria (combination therapy with lenalidomide/rituximab, combination with GemOx, or single-agent after 2+ prior therapies). For follicular lymphoma patients receiving Epkinly with lenalidomide and rituximab, track cycle count in billing system and enforce the 12-cycle maximum authorization limit. Update encounter forms and billing software to capture the specific treatment indication and drug combination to support medical necessity documentation. Claims submitted without prior authorization or outside approved indications will be denied.

Affected Billing Codes

96401
J9321
J9184
J9196
J9198
J9201
J9263
J9312
C82.00
C82.99
C83.00
C83.09
C83.30
C83.3A
C83.50
C83.59
C83.80
C83.89
C85.10
C85.19
C85.20
C85.29
C88.40
C88.41
D47.Z1