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CommercialPrior AuthHigh impact

Levoleucovorin (Khapzory) (CPB 0889, reviewed 2025-12-04)

Aetna·Oncology, Hematology, Pediatrics·Medical Policy
Effective date
Dec 4, 2025
We identified it
Aug 16, 2026
Days to comply

Summary

Aetna is implementing a cost-containment policy for Levoleucovorin (Khapzory) that requires precertification for all commercial medical plan members. Khapzory is now considered medically necessary only when leucovorin is unavailable or when members have a contraindication, intolerance, or ineffective response to generic levoleucovorin. Generic levoleucovorin is now the preferred first-line option for all three approved indications.

Action Required

Action needed
Effective immediately: (1) Billing team must implement precertification requirement for ALL Levoleucovorin (Khapzory) claims submitted to Aetna commercial plans. Route all J0642 (Khapzory) requests through precertification process: call (866) 752-7021 or fax (888) 267-3277 BEFORE claim submission. (2) Update billing system to flag J0642 (Khapzory) for mandatory prior authorization; system should default to J0641 (generic levoleucovorin) or J0640 (leucovorin) unless prior auth is approved. (3) Revise clinical documentation requirements: providers must document ONE of the following before Khapzory authorization will be granted: (a) contraindication to generic levoleucovorin, (b) documented intolerance/allergic reaction to generic levoleucovorin, or (c) ineffective response/treatment failure with generic levoleucovorin. (4) Update encounter forms and order entry templates to prompt providers to justify Khapzory selection with specific medical necessity documentation. (5) Train billing and clinical staff that leucovorin shortage documentation from FDA Drug Shortages Index is required to support continuation therapy requests. (6) For Medicare Part B claims, refer to separate Medicare criteria (not included in this policy). Failure to obtain precertification will result in Aetna claim denials for J0642.

Affected Billing Codes

96365
96366
96367
96368
J0641
J0642
J0640
J8610
J8611
J8612
J9190
J9250
J9255
J9260