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Epiretinal radiation describes the administration of radiation to the choroidal vascular bed of the retina. The NeoVista Epi-Rad90™ Ophthalmic System, which is inserted into the vitreous cavity and positioned under visual guidance over the target lesion, is being evaluated to treat choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD). Proton beam therapy and stereotactic radiotherapy are also being evaluated for the treatment of AMD.
AMD is the leading cause of legal blindness in individuals older than age 60 in developed nations. 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 believed to be 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.
Other Treatments for AMD
Other available therapeutic options for AMD not addressed in this policy include photodynamic therapy, (see Photodynamic Therapy for Subfoveal Choroidal Neovascularization) and vascular endothelial growth factor (VEGF) antagonists or angiostatics (see Intravitreal Angiogenesis Inhibitors for Choroidal Vascular Conditions). For those whose visual losses impair their ability to perform daily tasks, low-vision rehabilitative services offer resources to compensate for deficits. Another treatment for AMD that is considered investigational is addressed in the following policy: Transpupillary Thermotherapy for Treatment of Choroidal Neovasculariation.
An 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.
POLICYIntraocular placement of a radiation source for the treatment of choroidal neovascularization is considered investigational.
Intraocular proton beam therapy for the treatment of choroidal neovascularization is considered investigational.
Stereotactic radiation therapy for the treatment of choroidal neovascularization is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (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.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY7/16/2008: Policy added
11/20/2008: Approved by Medical Policy Advisory Committee (MPAC)
04/23/2010: Policy description and statement unchanged. FEP verbiage added to the Policy Exceptions section.
04/20/2011: Policy reviewed; no changes.
03/27/2012: Policy reviewed; no changes.
07/19/2013: Policy title changed from "Epiretinal Radiation Therapy for Age-Related Macular Degeneration" to "Intraocular Radiation Therapy for Age-Related Macular Degeneration." Added the following investigational policy statement: Intraocular proton beam therapy for the treatment of choroidal neovascularization is considered investigational.
09/16/2014: Policy reviewed; description updated regarding other treatments for AMD. Added policy statement that stereotactic radiation therapy for the treatment of choroidal neovascularization is considered investigational.
02/27/2015: Policy title updated to change "Radiation Therapy" to "Radiotherapy." Policy description updated. Policy statements unchanged.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 9.03.20
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.