Verteporfin - Effective April 3, 2013

80.3.1 - Verteporfin - Effective April 3, 2013 (Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, Implementation: Upon Implementation of ICD-10) A. General Verteporfin, a benzoporphyrin derivative, is an intravenous lipophilic photosensitive drug with an absorption peak of 690 nm. Verteporfin was first approved by the Food and Drug Administration on April 12, 2000, and subsequently approved for inclusion in the United States Pharmacopoeia on July 18, 2000, meeting Medicare’s definition of a drug as defined under §1861(t)(1) of the Social Security Act. Verteporfin is only covered when used in conjunction with ocular photodynamic therapy (OPT) when furnished intravenously incident to a physician’s service. B. Nationally Covered Indications Effective April 1, 2004, OPT with verteporfin is covered for patients with a diagnosis of neovascular age-related macular degeneration (AMD) with: • Predominately classic subfoveal choroidal neovascularization (CNV) lesions (where the area of classic CNV occupies ≥50% of the area of the entire lesion) at the initial visit as determined by a fluorescein angiogram (FA). (CNV lesions are comprised of classic and/or occult components.) Subsequent follow-up visits require either an optical coherence tomography (effective April 3, 2013) or an FA (effective April 1, 2004) to access treatment response. There are no requirements regarding visual acuity, lesion size, and number of retreatments when treating predominantly classic lesions. • Subfoveal occult with no classic CNV associated with AMD. • Subfoveal minimally classic CNV (where the area of classic CNV occupies <50% of the area of the entire lesion) associated with AMD. The above 2 indications are considered reasonable and necessary only when: 1. The lesions are small (4 disk areas or less in size) at the time of initial treatment or within the 3 months prior to initial treatment; and, 2. The lesions have shown evidence of progression within the 3 months prior to initial treatment. Evidence of progression must be documented by deterioration of visual acuity (at least 5 letters on a standard eye examination chart), lesion growth (an increase in at least 1 disk area), or the appearance of blood associated with the lesion. C. Nationally Non-Covered Indications Other uses of OPT with verteporfin to treat AMD not already addressed by the Centers for Medicare & Medicaid Services will continue to be non-covered. These include, but are not limited to, the following AMD indications: juxtafoveal or extrafoveal CNV lesions (lesions outside the fovea), inability to obtain an FA, or atrophic or “dry” AMD. D. Other The OPT with verteporfin for other ocular indications, such as pathologic myopia or presumed ocular histoplasmosis syndrome, continue to be eligible for local coverage determinations through individual A/B MAC discretion.