IV-154-003

Medical Policy:

IV-154-003

Topic:

Artificial Retinal Devices

Section:

Surgery

Effective Date:

September 2, 2019

Issued Date:

September 28, 2020

Last Revision Date:

August 2019

Annual Review:

September 2020

This policy version was replaced on November 1, 2021. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

An artificial retinal device, also referred to as retinal prosthesis, is a device that replaces lost photoreceptor function by transmitting external images to an array of electrodes or via light sensors placed in the epiretinal or subretinal space. The artificial retina would restore sight to patients with blindness secondary to retinal diseases such as retinitis pigmentosa, hereditary retinal degeneration, and some forms of age-related macular degeneration. Several models of retinal prostheses are under development; only the Argus II® system has been cleared for use by the U.S. Food and Drug Administration (FDA).

In 2013, the Argus® II Retinal Prosthesis System was cleared for marketing by the FDA through a humanitarian use device exemption (HDE). HDE approval is limited to devices that treat or diagnose fewer than 4000 people in the United States each year. The Argus® II system is intended for use in adults, age 25 years or older, with severe-to-profound retinitis pigmentosa who have bare light perception or no light perception in both eyes, evidence of intact inner layer retina function, and a history of the ability to see forms.

Definitions

Aphakia is the absence or loss of the eye's natural crystalline lens.

Bare light perception indicates that the patient can perceive light, but not the direction from which it is coming.

Pseudoaphakia refers to having an artificial lens implanted after the natural eye lens has been removed.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

The Argus II Retinal Prosthesis may be considered MEDICALLY NECESSARY and APPROPRIATE in accordance with the U. S. Food and Drug Administration (FDA) section regarding FDA labeling and Humanitarian Device Exemption (HDE) for retinal prosthesis when ALL of the following criteria are met:

The patient is 25 years or older; AND
There is a previous history of useful vision; AND
Bare light or no light perception in both eyes (if the patient has no residual light perception, then evidence of intact inner layer retina function must be confirmed); AND
The patient is aphakic or pseudophakic (if the patient is phakic prior to implant, the natural lens will be removed during the implant procedure); AND
The patient is willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation; AND
The Argus II implant will be implanted in a single eye.

The Argus II implant is considered EXPERIMENTAL/INVESTIGATIVE for all other indications due to the lack of clinical evidence demonstrating an impact on improved health outcomes.

0100T 0472T 0473T C1841 V2799

Denial Statements

No additional statements.

Links

Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.

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Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.

Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement.

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