Epiretinal radiation describes the intraocular administration of radiation to the choroidal vascular bed of the retina to treat age-related macular degeneration (AMD). AMD is characterized in its earliest stages by minimal visual impairment and the presence of large drusen and other pigmentary abnormalities on ophthalmoscopic examination. Two distinctively different forms of degeneration may be observed. The first, called the atrophic or areolar or dry form, evolves slowly. Atrophic AMD is the most common form of degeneration and may be a precursor of the more visually impairing exudative neovascular form, also referred to as disciform or wet AMD. The wet form is distinguished from the atrophic form by the development of choroidal neovascularization (CNV) and serous or hemorrhagic detachment of the retinal pigment epithelium. Risk of developing severe irreversible loss of vision is greatly increased by the presence of CNV.
The NeoVista Epi-Rad90™ Ophthalmalic System has been developed to treat CNV by focal delivery of radiation to a subfoveal choroidal neovascular lesion. Using a standard vitrectomy procedure, the cannula tip of a handheld (pipette-like) surgical device is inserted into the vitreous cavity and positioned under visual guidance over the target lesion. The radiation source (strontium-90) is advanced down the cannula until it reaches the tip, which is then held in place over the lesion for a “prescribed” time to deliver focused radiation. The system is designed to deliver a one-time peak dose of beta particle energy (24 Gy) for a target area 3 mm in depth and up to 5.4 mm in diameter. This is below the dose that is toxic to the retina and optic nerve, and radiation exposure outside of the target area is expected to be minimal. A investigational device exemption (IDE) has been granted by the U.S. Food and Drug Administration (FDA) for a phase III multi-center trial to provide data for application to the FDA; this is a category B procedure.
Other Treatments for AMD
Other available therapeutic options for AMD not addressed in this policy include photodynamic therapy (policy No. 9.03.08) and vascular endothelial growth factor (VEGF) antagonists or angiostatics. Angiostatic agents target various points in the pathway leading to new blood vessel formation (angiogenesis): messenger RNA; vascular endothelial growth factors (VEGFs); endothelial cell proliferation, migration, and proteolysis. Pegaptanib (Macugen®, Eyetech and Pfizer) and ranibizumab (Lucentis™, Genentech) are presently the only angiostatic drugs FDA-approved for use in AMD. Pegaptanib and ranibizumab bind extracellular VEGF to inhibit the angiogenesis pathway and are administered by intravitreous injections every 4-6 weeks. Bevacizumab (Avastin, Genentech) has been used off-label to treat AMD. It is derived from the same murine monoclonal antibody precursor as ranibizumab and is FDA-approved for the treatment of metastatic cancer of the colon or rectum.
For those whose visual losses impair their ability to perform daily tasks, low-vision rehabilitative services offer resources to compensate for deficits. Other treatments for AMD that are considered investigational and/or not medically necessary are addressed in policy Nos. 9.03.10 (transpupillary thermotherapy), 9.03.11 (photocoagulation of macular drusen) and 9.03.16 (anecortave acetate).

Intraocular placement of a radiation source for the treatment of choroidal neovascularization is considered investigational.

There will be a new CPT category III code for this procedure effective July 2008:

0190T: Placement of intraocular radiation source applicator (List separately in addition to primary procedure)

CPT code 0190T is to be used in conjunction with 67036 (Vitrectomy, mechanical, pars plana approach).

CPT code 0190T differs from code 67218 (destruction of localized lesion of the retina [e.g., macular edema, tumors], one or more sessions; radiation by implantation of source) because the radiation source is not implanted.

BlueCard/National Account Issues

State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

1. Stevenson MR, Hart PM, Chakravarthy U et al. Visual functioning and quality of life in the SubFoveal Radiotherapy Study (SFRADS): SFRADS report 2. Br J Ophthalmol 2005; 89(8):1045-51.
2. A prospective, randomized, double-masked trial on radiation therapy for neovascular age-related macular degeneration (RAD Study). Radiation Therapy for Age-related Macular Degeneration. Ophthalmology 1999; 106(12):2239-47.
3. http://www.clinicaltrials.gov/ct2/show/NCT00454389

Age-Related Macular Degeneration, Treatment

Ranibizumab