Ocular Photodynamic Therapy (OPT)

CMS National Coverage Determination | ncd_id=349 | manual_section=80.2.1 | coverage_level_code=2 | national_coverage_type=True | under_review=True | lab_ncd=False

B. Nationally Covered Indications Effective April 1, 2004, OPT with verteporfin continues to be approved for a diagnosis of neovascular AMD with predominately classic subfoveal CNV lesions (where the area of classic CNV occupies ≥ 50% of the area of the entire lesion) at the initial visit as determined by an FA. (CNV lesions are comprised of classic and/or occult components.) Subsequent follow-up visits require either an optical coherence tomography (OCT) (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 re-treatments when treating predominantly classic lesions. In addition, after thorough review and reconsideration of the August 20, 2002, non-coverage policy, CMS determines that the evidence is adequate to conclude that OPT with verteporfin is reasonable and necessary for treating: Subfoveal occult with no classic CNV associated with AMD; and, Subfoveal minimally classic CNV (where the area of classic CNV occupies The above 2 indications are considered reasonable and necessary only when: 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, 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 CMS 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 a fluorescein angiogram, 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 Medicare Administrative Contractor discretion.