Prior authorization validity and renewals

Initial prior authorization is required. Initial authorization is valid for 12 months (365 days) for most indications and 3 months (90 days) for myopic choroidal neovascularization (mCNV). Renewals may be requested every 12 months (365 days) thereafter (or every 3 months/90 days for mCNV) if renewal criteria are met.

• Initial: 12 months (365 days) standard; mCNV: 3 months (90 days).
• Renewal frequency matches initial validity (12 months or 3 months for mCNV) subject to meeting renewal criteria.

ICD-10 diagnosis coding required with product HCPCS/NDC

Use the HCPCS/NDC product codes listed in the policy and submit an appropriate ICD-10 diagnosis code from the policy’s ICD-10 lists to support medical necessity for the requested ranibizumab product.

• Byooviz mapping and ICD-10 lists are shown under Byooviz (Q5124) entries.
• Lucentis/Cimerli/Nufymco HCPCS mappings and ICD-10 lists are shown under the respective product sections.

Check CMS/NCD/LCD/LCAs for Medicare prior authorization rules

When Medicare Part B is the payer, verify and comply with applicable CMS guidance, NCDs, LCDs, and LCAs before submission, since Medicare rules govern coverage for outpatient Part B drugs and may impose different requirements.

• Refer to Medicare Benefit Policy Manual Chapter 15 §50 and search the CMS Medicare Coverage Database for NCDs/LCDs/LCAs.

Document prior inadequate response or contraindication to bevacizumab

Members must have an inadequate response to an adequate trial of bevacizumab, or a documented contraindication or intolerance to bevacizumab, prior to initiating ranibizumab therapy.

• Step therapy with bevacizumab is required unless a contraindication/intolerance is documented.
• This requirement applies to initial authorization criteria for ranibizumab products.

Document baseline and periodic BCVA and clinical benefit

Measure and document best corrected visual acuity (BCVA) at baseline and periodically during treatment; for renewal, document clinical benefit (e.g., BCVA improvement or disease stabilization) and absence of unacceptable toxicity.

• BCVA must be measured at baseline and periodically during treatment.
• Renewal requires documentation of beneficial response (e.g., BCVA improvement) and absence of unacceptable toxicity.

Use policy ICD-10 codes to support medical necessity for Byooviz and related products

ICD-10 diagnosis codes listed in the policy must be used to support medical necessity for Byooviz (Q5124) and other ranibizumab products; map the patient’s diagnosis and laterality to the exact ICD-10 code in the policy lists.

• Use the ICD-10 code entries provided under each product section (e.g., Byooviz (Q5124) or Lucentis/Cimerli/Nufymco) to support claims.
• Ensure code reflects correct eye laterality and condition as listed.

ICD-10 documentation requirement for claims submission

When submitting claims, use the appropriate ICD-10 diagnosis codes from the policy’s ICD-10 lists to substantiate medical necessity for ranibizumab products.

• Select the exact ICD-10 code matching the listed condition and laterality.
• Policy contains extensive ICD-10 series for diabetic retinopathy, AMD, RVO, mCNV, etc.

Avoid concomitant or alternating VEGF inhibitor regimens without justification

Concomitant use of ranibizumab with other ophthalmic VEGF inhibitors, or use in an alternating regimen, is generally not permitted and may be reviewed and denied if not clinically justified.

• Ranibizumab may be used as supplemental treatment with Susvimo per the policy, but alternating regimens with other VEGF inhibitors will be reviewed on a case-by-case basis.
• Concomitant or alternating regimens outside policy allowances can trigger review or denial.

Denial risk if bevacizumab trial or contraindication not documented

Failure to document an inadequate response to an adequate bevacizumab trial, or a documented contraindication/intolerance to bevacizumab, may result in denial of prior authorization for ranibizumab.

• Document the trial details and clinical rationale if bevacizumab was ineffective or not tolerated.

Proprietary information — restricted access

Proprietary information restrictions apply to this policy document; do not disseminate or copy without approval.

• Policy states: 'Proprietary Information. Restricted Access -Do not disseminate or copy without approval.'

Medicare compliance may trigger denial if NCD/LCD/LCA rules are not met

Claims for Medicare Part B must comply with applicable NCDs, LCDs, and LCAs; failure to follow these Medicare-specific rules may affect coverage decisions and lead to denial for Part B claims.

• Medicare outpatient drug coverage is governed by the Medicare Benefit Policy Manual Chapter 15 §50 and any applicable NCDs/LCDs/LCAs.
• Use the CMS Medicare Coverage Database to identify applicable determinations prior to submission.