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CommercialCoverageMedium impact

Asparaginase Erwinia Chrysanthemi (Recombinant)-rywn (Rylaze) (CPB 0864, reviewed 2025-12-02)

Aetna·Oncology, Hematology, Pediatrics·Medical Policy
Effective date
Dec 2, 2025
We identified it
Aug 12, 2026
Days to comply

Summary

Aetna has released an updated Clinical Policy Bulletin (CPB 0864) for Rylaze (asparaginase erwinia chrysanthemi recombinant-rywn), effective immediately. The policy covers Rylaze for ALL/LBL and ENKL/ANKL in commercial medical plans when patients have developed hypersensitivity to E. coli-derived asparaginase and the drug is used with multi-agent chemotherapy. Billing teams must ensure claims include proper diagnosis codes, prior authorization if required, and use the correct HCPCS code J9021 for this recombinant formulation.

Action Required

Action needed
By December 2, 2025: Billing team must implement the following changes: (1) Update billing system to recognize J9021 (Rylaze) as a covered HCPCS code for commercial Aetna plans when billed with appropriate ICD-10 diagnosis codes (C83.50-C83.59, C86.01-C86.61, C91.00-C91.02, C94.80-C94.82); (2) Establish prior authorization workflow requiring documentation that patient has developed hypersensitivity to E. coli-derived asparaginase (pegaspargase/J9266) and that Rylaze will be used with multi-agent chemotherapy; (3) Update claim scrubbing rules to deny J9021 claims for non-covered indications (brain tumors, lymphomas other than specified types, other malignancies); (4) Alert oncology providers to include in authorization requests: confirmation of prior E. coli asparaginase hypersensitivity, multi-agent chemotherapy plan documentation, and proper ICD-10 diagnosis coding; (5) Note that therapeutic drug monitoring (asparaginase activity levels) is not covered and should not be billed. Failure to obtain proper prior authorization or use correct codes will result in claim denials.

Affected Billing Codes

96401
96409
96411
96413
96414
96415
96416
96417
J9021
J9020
J9266
C83.50
C83.51
C83.52
C83.53
C83.54
C83.55
C83.56
C83.57
C83.58
C83.59
C86.01
C86.02
C86.03
C86.04
C86.05
C86.06
C86.61
C91.00
C91.01
C91.02
C94.80
C94.81
C94.82