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Medicare News Update Medicare Information Resource
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MIR-2006-8A, August 2006
Coverage for Lucentis™ (ranibizumab injection)
Indications
Ranibizumab was approved by the Food and Drug Administration (FDA) on June 30, 2006 for treatment of patients with exudative senile macular degeneration. The recommended dosage and frequency of treatment is 0.5 mg/0.05mL (10mg/mL), administered by intravitreal injection once in 30 days. Treatment may be continued monthly or reduced to one injection every three months after the first four injections, if monthly treatments are not feasible. Compared to monthly dosing, however, it is expected that quarterly dosing may be less effective, and as such, patients should be evaluated regularly.
Claims for ranibizumab should be reported with HCPCS C9399 (for dates of service prior to October 3, 2005) or HCPCS C9224 (for dates of service on or after October 3, 2006). The administration for ranibizumab must be billed on the same claim as the drug with CPT code 67028 (intravitreal injection of a pharmacologic agent). Report modifier RT or LT with this code, as appropriate. If both eyes are treated on the same date, then the intravitreal injection must be reported on a single claim line using bilateral modifier -50. The only payable diagnosis code for this treatment is ICD-9-CM code 362.52 (Exudative senile macular degeneration; wet).
Please refer to Medicare News Update, issue 2004-8, “Hospital Outpatient Billing and Payment Under OPPS for New Drugs or Biologicals After FDA Approval but Before Assignment of a Product-Specific Drug/Biological HCPCS Code” and issue 2005-10, “Update of the Hospital OPPS” for additional billing information .
Documentation Requirements
Clinical records must document the appropriate conditions necessitating the injection.
Sources of Information
- Genentech Lucentis Corporation press release, “FDA Approves Lucentis for the Treatment of Patient’s Neovascular (wet) Age-Related Macular Degeneration (AMD).” June 30, 2006
- FDA News Release, June 30, 2006
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