Obtain prior authorization — 90‑day initial approval; age ≥6

Prior authorization is required for IV levoleucovorin. Initial prior authorization validity will be provided for 90 days and may be renewed every 90 days. The member must be at least 6 years of age to meet initial authorization requirements.

PA considered for indication and cost per NQTL checklist

Prior authorization may be applied based on the clinical indication and the drug’s cost. Appendix A’s NQTL checklist identifies "Indication: Consider for PA" and "Cost of drug: Consider for PA," so providers should expect PA review when the indication relevance or cost is a concern.

Follow applicable CMS NCDs/LCDs for Medicare Part B cases

When Medicare Part B is relevant, follow applicable CMS guidance and any National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs). Coverage determinations for outpatient (Part B) drugs are governed by the Medicare Benefit Policy Manual and any applicable NCD/LCD/LCA.

Document prior trial or intolerance to Fusilev before Khapzory

For Khapzory (levoleucovorin), prior authorization requires documentation that the member had an inadequate response to, or a contraindication/intolerance of, Fusilev before Khapzory coverage is approved (Khapzory‑only prerequisite).

Bill using HCPCS J0641 / J0642 and applicable NDC(s)

Use the listed HCPCS and NDCs when submitting claims: bill levoleucovorin as J0641 (Fusilev) or J0642 (Khapzory), 1 billable unit = 0.5 mg, and include the applicable NDC for Fusilev or Khapzory (e.g., Fusilev 72893-0009-xx, 72893-0013-xx, 72893-0014-xx; Khapzory 72893-0004-xx, 72893-0006-xx).

Refer to Appendix A for the NQTL factor checklist

Appendix A contains the Non‑Quantitative Treatment Limitations (NQTL) factor checklist that documents the NQTL factors considered when designing and applying prior authorization for this drug/drug group.

Submit supporting ICD‑10 diagnosis code from Appendix 1

Include an appropriate ICD‑10 diagnosis code from Appendix 1 on the claim to support medical necessity for IV levoleucovorin; use the covered diagnosis code that corresponds to the member’s indication (see Appendix 1 list).

Confirm FDA shortage before coverage when racemic product is required

For indications that rely on racemic d,l‑leucovorin being unavailable, coverage requires confirmation that racemic d,l‑leucovorin calcium is not obtainable in any dosage strength as confirmed by the FDA Drug Shortage website (http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm).

PA may be applied for NQTL‑driven utilization concerns

Prior authorization may be applied when indication relevance or drug cost raises utilization management concerns; the policy notes that utilization management NQTLs may restrict benefits comparably across MH/SUD and M/S drugs.

Medicare Part B coverage/payment triggers — follow CMS rules

Medicare Part B coverage and payment for outpatient administration are governed by the Medicare Benefit Policy Manual and any applicable NCDs/LCDs/LCAs; providers must comply with these CMS rules where applicable.

Monitor serum creatinine and methotrexate levels during IV administration

For IV administration in infusion center or hospital outpatient settings, follow dosing and monitoring guidance in the policy, including monitoring serum creatinine and methotrexate levels at least every 24 hours during rescue.

Apply Medicare Part B rules and NCD/LCDs for outpatient administration/payment

When administering in an outpatient infusion center under Medicare Part B, follow Medicare rules and any applicable NCDs/LCDs for coverage and payment; consult CMS guidance and local MACs as needed.