Obtain prior authorization; observe PA length rules

Prior authorization is required for ranibizumab and its biosimilars (J2778, Q5124, Q5128, Q5168). Initial PA validity is generally 12 months (365 days) except for myopic choroidal neovascularization (mCNV), where initial and renewal PA validity is 3 months (90 days). Members must meet the initial approval criteria (age ≥18, inadequate response or contraindication/intolerance to bevacizumab, absence of FDA‑labeled contraindications, no concomitant use with other ophthalmic VEGF inhibitors, baseline BCVA measurement, and a listed diagnosis).

• PA applies to J2778, Q5124, Q5128, Q5168 (see HCPCS list).
• Initial PA: 12 months (365 days) unless otherwise specified; mCNV: 3 months (90 days).
• Renewal PA: generally 12 months; mCNV renewals every 3 months (90 days).

Use product‑specific ICD‑10 diagnosis on PA request

Submit the ICD‑10 diagnosis code that corresponds specifically to the product being requested: each product (Byooviz Q5124; Lucentis J2778; Cimerli Q5128; Nufymco Q5168) requires an associated ICD‑10 from the policy’s enumerated lists.

• Do not use a diagnosis code not listed for the requested HCPCS/Q‑code.

Verify HCPCS/Q‑code is one of the listed products on the PA

Prior authorization/medical necessity review applies to the listed intravitreal anti‑VEGF HCPCS/Q‑codes (J2778, Q5128, Q5168) and will be evaluated using the policy’s listed ICD‑10 diagnosis codes for ophthalmic conditions.

• Ensure the HCPCS/Q‑code billed matches the product approved on the PA.
• Use the policy’s corresponding ICD‑10 codes for the indication being treated.

Demonstrate prior bevacizumab trial or contraindication

Document an inadequate response to an adequate trial of bevacizumab — or document a contraindication or intolerance to bevacizumab — before initiating ranibizumab therapy.

• Include dates, dosing, and objective evidence of inadequate response or clinical rationale for intolerance/contraindication to bevacizumab.

Provide required clinical documentation (BCVA, response, bevacizumab history)

Ensure documentation includes baseline and periodic best corrected visual acuity (BCVA) measurements and evidence of treatment response or ongoing disease activity for renewals; also include documentation of inadequate response or contraindication/intolerance to bevacizumab when applicable.

• Record baseline BCVA and follow‑up BCVA values used to support initial approval and renewal.
• For renewals, document beneficial response (e.g., BCVA improvement) or, for mCNV, evidence of disease activity (drop in vision, symptoms, intra-/sub‑retinal fluid or active leakage).

Include the policy‑listed ICD‑10 diagnosis for the billed product

When requesting coverage for a specific ranibizumab product, submit one of the policy‑listed ICD‑10 diagnosis codes that correspond to that product’s covered indications (see the policy’s enumerated diagnosis lists).

• Byooviz (Q5124) and Lucentis/Cimerli/Nufymco each have their own enumerated ICD‑10 lists; use the correct list for the product billed.

Follow Medicare documentation and coverage requirements for Part B

Refer to Medicare guidance when the member is covered under Medicare Part B: follow the Medicare Benefit Policy Manual Chapter 15, §50 and applicable NCDs/LCDs/LCAs accessible via the CMS coverage database; compliance with these CMS policies is required where applicable and may affect coverage.

• Use https://www.cms.gov/medicare-coveragedatabase/search.aspx to locate relevant NCD/LCD/LCA documents for Part B claims.

Avoid contraindications, concomitant VEGF inhibitor use, and missing BCVA documentation

Requests may be denied if the member has FDA‑labeled contraindications to the requested agent, if therapy is to be used concomitantly with other ophthalmic VEGF inhibitors (alternating regimens are generally not permitted), or if baseline and periodic BCVA are not documented.

• Alternating use with other ophthalmic VEGF inhibitors is generally not permitted and is reviewed case‑by‑case.
• Confirm absence of ocular/periocular infection and other FDA‑labeled contraindications before submission.

Risk of denial for diagnosis code mismatch

Claims lacking a listed, supported ICD‑10 diagnosis code from the policy’s diagnosis lists for the specific drug (for example, Byooviz Q5124) risk denial.

• Validate that the claim diagnosis code is present in the policy’s enumerated list for the HCPCS/Q‑code being billed.

Noncompliance with Medicare NCD/LCD/LCA requirements may cause denial

Claims for members covered by Medicare Part B may be subject to applicable Medicare NCDs/LCDs/LCAs; noncompliance with those CMS policies (documented in the Medicare Benefit Policy Manual and CMS coverage database) may affect coverage determinations and lead to denial.

• Check for applicable NCD/LCD/LCA requirements before billing and include required documentation per CMS where relevant.