Prior authorization validity (initial and renewal)

Initial and renewal prior authorizations are each valid for 120 days (4 months).

Prior authorization and required HCPCS codes

Prior authorization applies to non-preferred short-acting G-CSF products and must use the listed HCPCS codes for PA requests and claims billing.

• Affected HCPCS codes: J1442, Q5110, Q5101, J1447, Q5125, Q5148, J3590, C9399 (use appropriate code per product and setting).

Medicare NCD/LCD applicability

Medicare Part B coverage determinations (NCDs/LCDs/LCAs) apply where relevant; providers must follow applicable Medicare contractor policies and CMS guidance for outpatient Part B drugs.

Zarxio step requirement (step therapy)

Zarxio is the preferred short-acting G-CSF and does not require prior authorization; the member must have failed, or have a contraindication or intolerance to Zarxio before other short-acting G-CSF products are considered.

Utilization management considerations for PA

Utilization management considered indication and drug cost as reasons for applying prior authorization; safety/efficacy and potential for misuse were not prioritized for PA per the NQTL checklist.

• NQTL factors: Indication = consider for PA; Cost of drug = consider for PA; Safety/efficacy = PA not a priority; Potential for misuse/abuse = PA not a priority.

Required clinical documentation (ANC, diagnosis, risk factors)

Include documentation of absolute neutrophil count (ANC) where relevant, the covered diagnosis (e.g., congenital, cyclic, or idiopathic neutropenia), and relevant risk factors for febrile neutropenia when requesting coverage.

• ANC values (when applicable) and fever/ANC criteria for febrile neutropenia.
• Diagnosis supporting indication (congenital, cyclic, idiopathic neutropenia, BMT/PBPC status, AML, etc.).
• Member-related risk factors (age >65, prior chemo/radiation, persistent neutropenia, bone marrow involvement, HIV, recent surgery/open wounds, poor performance status, renal/liver dysfunction, chronic post-transplant immunosuppression).

Renewal documentation requirements

For renewal, provide documentation that the member continues to meet the indication-specific criteria identified in Section III (including concomitant therapy requirements and performance status) and that there is no unacceptable toxicity from the drug.

• Demonstrate continued meeting of indication-specific requirements.
• Confirm absence of unacceptable toxicity (see examples in policy).
• Support continued need with relevant encounter/transplant/chemotherapy status codes where applicable.

Support PA with covered diagnosis codes (Appendix 1)

Documentation supporting PA requests should include one of the covered ICD-10 diagnosis codes listed in Appendix 1 appropriate to the indication.

• Include relevant encounter and transplant/chemotherapy status codes where applicable (e.g., Z51.11, Z94.81, Z94.84).
• Use diagnosis codes from Appendix 1 that match the clinical indication.

Renewal denial risk: unacceptable toxicity

Renewal may be denied if the member has unacceptable toxicity from the drug; absence of these toxicities is required for renewal eligibility.

Examples of unacceptable toxicities (deny renewal)

Examples of unacceptable toxicities that preclude renewal include splenic rupture, acute respiratory distress syndrome (ARDS), serious allergic reactions/anaphylaxis, sickle cell crisis, glomerulonephritis, leukocytosis, capillary leak syndrome, potential tumor growth stimulation, aortitis, alveolar hemorrhage/hemoptysis, thrombocytopenia, cutaneous vasculitis, and MDS/AML in certain contexts.

• Splenic rupture
• ARDS
• Serious allergic reactions/anaphylaxis
• Sickle cell crisis
• Glomerulonephritis
• Leukocytosis
• Capillary leak syndrome
• Potential tumor growth stimulation of malignant cells
• Aortitis
• Alveolar hemorrhage and hemoptysis
• Thrombocytopenia
• Cutaneous vasculitis
• MDS/AML (when used for congenital neutropenia or with chemotherapy/radiation in breast or lung cancer)

Medicare coverage compliance for claims

Claims for Medicare Part B members must comply with applicable Medicare NCDs, LCDs, and LCAs; failure to follow applicable NCD/LCD may result in denial for Medicare Part B claims.