CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy | Retinal Prosthesis

Defines coverage stance for retinal prostheses for Medicare Advantage and commercial products, summarizes evidence and background, lists not-covered / not medically necessary procedure and supply codes. Does not require prior authorization or specify medical criteria.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy | Retinal Prosthesis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2023

Next Review Date

Key ActionDo not cover retinal prostheses for Medicare Advantage; consider retinal prostheses not medically necessary for commercial products due to insufficient evidence.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes identified in this update.

2Product types with negative coverage stance (Medicare Advantage, Commercial)

4Procedure/supply codes listed as not covered

0Prior authorization required

Coverage Summary

Retinal prostheses (epiretinal, subretinal, suprachoroidal approaches) are investigational technologies intended to restore vision in degenerative retinal diseases such as retinitis pigmentosa and other hereditary retinal degenerations. Multiple devices have been developed and studied (for example, Argus II, Alpha IMS, PRIMA), but devices discussed in the policy are not FDA-cleared or approved except for the Argus II noted in the literature. Available evidence to date (including a 2016 systematic review and small prospective studies) is insufficient to demonstrate a net health benefit on functional outcomes, quality of life, or treatment-related morbidity.

Medical Necessity & Administrative Requirements

Coverage Determination

Policy position by product type:

Medicare Advantage Plans: Retinal prostheses are not covered as the evidence is insufficient to determine the effects of the technology on health outcomes.
Commercial Products: Retinal prostheses are considered not medically necessary as the evidence is insufficient to determine the effects of the technology on health outcomes.

Administrative Requirements

Medical Criteria: Not applicable
Prior Authorization: Not applicable

Not Covered / Experimental

Retinal prostheses are considered not covered / not medically necessary for the listed product types: for Medicare Advantage Plans they are not covered, and for Commercial Products they are considered not medically necessary. This stance reflects the policy conclusion that the current evidence is insufficient to determine the effects of retinal prosthesis technologies on health outcomes.

Systematic review (AHRQ 2016): concluded that the evidence on retinal prostheses was insufficient on all outcomes of interest, supporting the determination that net health benefit is not established.

Argus II clinical trial (n≈30): small prospective single-arm study showed improved performance on some computer-based tests with the device on versus off, but practical task improvements were inconsistent and may not be clinically meaningful; results are limited by small sample size, repeated testing of the same patients, and lack of additional prospective comparative data.

Procedure & Supply Codes

Not covered / Not medically necessary codesmixedNot Covered

0100T	Placement of a subconjunctival retinal prosthesis receiver and pulse generator, and implantation of intra-ocular retinal electrode array, with vitrectomy
0472T	Device evaluation, interrogation, and initial programming of intraocular retinal electrode array (eg, retinal prosthesis), in person, with iterative adjustment of the implantable device to test functionality, select optimal permanent programmed values with analysis, including visual training, with review and report by a qualified health care professional
0473T	Device evaluation and interrogation of intraocular retinal electrode array (eg, retinal prosthesis), in person, including reprogramming and visual training, when performed, with review and report by a qualified health care professional
L8608	Miscellaneous external component, supply or accessory for use with the Argus II Retinal Prosthesis System

Provider Actions & Billing Impact

Denial Risk

Denial Risk: Not Covered

Retinal prosthesis procedures and supplies listed are not covered / not medically necessary for Medicare Advantage and commercial products; claims for these codes are at risk of denial.

Affected codes: list codes from code_groups[0] (0100T, 0472T, 0473T, L8608)
Prior authorization: Not applicable per criteria_trees[1]

Documentation Required

Documentation & Prior Authorization

Policy specifies no medical criteria or prior authorization is not applicable; document clinical rationale if submitting an exception request.

Background & Evidence Summary

Retinal prostheses remain investigational. Device examples include epiretinal systems (eg, Argus II and other epiretinal implants), subretinal multi-photodiode arrays (eg, Alpha IMS, PRIMA), and other investigational approaches (eg, PRIMA, EPIRET3, Boston Retinal Implant Project, Pixium Vision devices, and suprachoroidal-transretinal stimulation systems).

Limitations of the evidence include that most devices are not approved or cleared by the FDA, studies are small and often single-arm, and the 2016 systematic review concluded evidence is insufficient across outcomes. The single FDA-approved device has been evaluated in approximately 30 patients with improvements on some laboratory visual tasks but inconsistent and possibly not clinically meaningful improvements on practical tasks; additional prospective studies and clinically meaningful functional outcome data are needed.

Systematic review (AHRQ 2016)Concluded evidence insufficient on outcomes of interest

Argus II clinical trial (n≈30)Improved performance on some computer-based tests with device on vs off; practical task improvements inconsistent and may not be clinically meaningful