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«National Medical Policy Subject: Artificial Retina Policy Number: NMP349 Effective Date*: June 2007 Updated: June 2016 This National Medical Policy ...»

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National Medical Policy

Subject: Artificial Retina

Policy Number: NMP349

Effective Date*: June 2007

Updated: June 2016

This National Medical Policy is subject to the terms in the

IMPORTANT NOTICE

at the end of this document

For Medicaid Plans: Please refer to the appropriate State’s Medicaid

manual(s), publication(s), citation(s), and documented guidance for

coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage

guidelines first:

Use Source Reference/Website Link National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* Other X None Use Health Net Policy Instructions  Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions.

 Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under “Reference/Website” and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2)  If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual.

 If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance.

PAGE 1 Artificial Retina Jun 16 Current Policy Statement Health Net, Inc. considers the Argus II Retinal Prosthesis System medically necessary, when provided in accordance with the Humanitarian Device Exemption (HDE) specifications of the U.S. Food and Drug Administration (FDA). Per the HDE, the device is intended for individuals with severe to profound retinitis pigmentosa

who meet the following criteria:

• Adults, age 25 years or older.

• 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.) • Previous history of useful form vision.

• Aphakic or pseudophakic. (If the patient is phakic prior to implant, the natural lens will be removed during the implant procedure.) • Patients who are willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation.

Codes Related To This Policy

NOTE:

The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive.

On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets.

ICD-9 Codes 362.50 Macular degeneration (senile), unspecified 362.74 Pigmentary retinal dystrophy ICD-10 Codes H35.30 Unspecified macular degeneration H35.52 Pigmentary retinal dystrophy CPT Codes 0100T Placement of a subconjunctival retinal prosthesis receiver and pulse generator, and implantation of intra-ocular retinal electrode array, with vitrectomy HCPCS Codes N/A Scientific Rationale – Update June 2015 Chuang et al. (2014) completed a systematic review and compared selected retinal implant models by examining publications describing five representative retinal prostheses: Argus II, Boston Retinal Implant Project, Epi-Ret 3, Intelligent Medical Implants (IMI) and Alpha-IMS (Retina Implant AG). Publications were analyzed using three criteria for interim success: clinical availability, vision restoration potential and long-term biocompatibility. Clinical availability: Argus II is the only device with FDA approval. Argus II and Alpha-IMS have both received the European CE Marking. All PAGE 2 Artificial Retina Jun 16 others are in clinical trials, except the Boston Retinal Implant, which is in animal studies. Vision restoration: resolution theoretically correlates with electrode number.

Among devices with external cameras, the Boston Retinal Implant leads with 100 electrodes, followed by Argus II with 60 electrodes and visual acuity of 20/1262.

Instead of an external camera, Alpha-IMS uses a photodiode system dependent on natural eye movements and can deliver visual acuity up to 20/546. Long-term compatibility: IMI offers iterative learning; Epi-Ret 3 is a fully intraocular device;

Alpha-IMS uses intraocular photosensitive elements. The authors concluded that based on the review of these three criteria, Alpha-IMS is the most likely to achieve long-term success decades later, beyond current clinical availability.

Rizzo et al. (2014) studied the anatomical and functional outcomes of Argus II Retinal Prosthesis System implantation in retinitis pigmentosa patients in 6 patients with a visual acuity no better than light perception. Implantation of the Argus II Retinal Prosthesis System was safely performed in all patients. One patient experienced postoperative elevation in intraocular pressure, which was controlled medically. In one patient, moderate detachment of the choroid occurred postoperatively, which resolved spontaneously. One patient withdrew from the study.





Wound dehiscence, endophthalmitis, or retinal detachment was not observed. All patients were able to locate a bright light on the ceiling and a dark line on the floor after the surgery. Performance in square localization tests improved in 4 patients, and direction of motion improved in 3 patients. One patient achieved grating visual acuity. Goldmann visual field test results improved in all patients. The authors concluded that the patients showed an improvement in visual tasks after the surgery, and the device was well tolerated and functional over a 1-year follow-up period. According to the authors, a rigorous patient selection process is necessary to maximize patient compliance with the rigorous follow-up testing schedule and lengthy, difficult rehabilitation process. While the results of this study are promising, prospective randomized studies with long-term follow-up are needed to evaluate the safety and efficacy of retinal prosthetic devices.

Scientific Rationale – Update June 2013 Retinitis pigmentosa (RP) comprises a group of inherited conditions that cause progressive retinal degeneration and affect the photoreceptors and retinal pigment epithelium. A family history is identified in about 70 percent of patients. Night blindness is one of the earliest symptoms, but can be so gradual that it may go unnoticed by patients. Loss of visual field is progressive, starting in the midperiphery and progressing more peripherally, resulting in a constricted visual field.

In February 2013, the United States Food and Drug Adminstration (FDA) approved the Argus II Retinal Prosthesis System under the humanitarian device exemption (HDE) application (i.e., The device is exempt from demonstrating effectiveness but there must be sufficient information to show a probable benefit for its intended use and indication for use). The approval was based in part on a clinical study of 30 participants with RP who received the Argus II Retinal Prosthesis System.

Investigators monitored the participants for adverse events related to the device or to the implant surgery and regularly assessed their vision for at least 2 years after receiving the implant. Following the implant surgery, 19 of 30 study patients experienced no adverse events related to the device or the surgery. Eleven study patients experienced a total of 23 serious adverse events, which included erosion of the conjunctiva, dehiscence (splitting open of a wound along the surgical suture), retinal detachment, inflammation, and hypotony (low intraocular pressure).

PAGE 3 Artificial Retina Jun 16 Per the FDA, "Pre-clinical in vitro and in vivo testing demonstrated the Argus II Retinal Prosthesis System meets applicable international standards and Second Sight-defined design requirements. A 6 patient feasibility study with a first generation device (Argus 16) demonstrated that a retinal prosthesis could be implanted chronically in human subjects. Long-term data collected from this study demonstrated the safety and proof of concept that an electrode array could be used to stimulate the retina to elicit visual percepts in blind subjects. Data from the Argus 16 study provided important design input for the next generation implant (Argus II), external equipment, and stimulation fitting strategies.

A 30 subject prospective clinical trial was conducted which demonstrated that the Argus II System is safe and will provide a probable benefit to the indicated patient population. All subjects in the clinical trial had been implanted a minimum of 2.5 years follow-up data, with several subjects having over 4 years of follow-up data.

The long-term safety results are acceptable, with the majority of events resolving with no or minimal intervention. Serious adverse events were clustered in a few subjects and most occurred within the first 6 months post-implant. Furthermore, based on a trend toward reduced adverse events as the trial progressed and more experience was gained with the device, it is likely that the safety profile of the Argus II System will continue to improve with increasing surgical experience with these devices. The risk, therefore, is acceptable, especially when considering that the adverse events are occurring in blind eyes, for which decreased vision is not a significant risk. The performance analysis showed that a majority of subjects using the Argus II System have improved visual function that ranged between subjects from light perception to at least hand motion, or counting fingers vision.

Assessments of subjects in their normal environments by low vision therapists also demonstrated that the majority of subjects received positive effects from the Argus II System in terms of well being and/or functional vision. These results represent a significant improvement and benefit for these subjects, especially when considering that they have no other approved treatment options for their irreversible degenerative disease. When considering all the data, it has been demonstrated that the Argus II System poses an acceptable risk to people with severe to profound retinitis pigmentosa in exchange for a probable benefit - that of improvements in visual function, functional vision, and/or well-being."

Per the approval, the device is indicated for use in patients with severe to profound

retinitis pigmentosa who meet the following criteria:

 Adults, age 25 years or older.

 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.)  Previous history of useful form vision.

 Aphakic or pseudophakic. (If the patient is phakic prior to implant, the natural lens will be removed during the implant procedure.)  Patients who are willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation.

The Argus II implant is intended to be implanted in a single eye, typically the worseseeing eye.

The HDE was approved subject to the post-approval requirements that include two post-approval studies, (.ie., Extended Follow-up of the Argusm II Retinal Stimulation

–  –  –

Contraindications:

 Ocular diseases or conditions that could prevent the Argus II System from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus, etc.).

 Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva, axial length 20.5 mm or 26 mm; corneal ulcers, etc.).

 Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. comeal opacity, etc.).

 Inability to tolerate general anesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery.

 Metallic or active implantable device(s) (e.g. cochlear implant) in the head.

 Any disease or condition (e.g. significant cognitive decline, etc.) that prevents understanding or communication of informed consent, fitting of the Argus II System, or post-operative follow-up. A pre-operative psychological evaluation  may be recommended to confirm the patient is not contraindicated based on this criterion.

 Predisposition to eye rubbing.

Individuals implanted with an Argus II Implant should not undergo short wave or microwave diathermy; electroconvulsive therapy (ECT) or monopolar electrosurgical equipment. If lithotripsy or high output ultrasound must be used, the treatment beam should not focus near the Argus II Implant. The Argus 11 Implant has been classified as an MR Conditional device thus individuals with an Argus II Implant may undergo a magnetic resonance imaging (MRI) procedure ONLY if it is performed using a 1.5 or 3.0 Tesla MRI System according to instuctions per device package insert. In addition, the Argus II System may interfere with the operation or accuracy of medical monitoring, diagnostic or life support equipment.

The FDA approval notes that at any time after implantation, Argus II patients have a risk of conjunctival complications which, if left untreated, may result in conjunctival erosion which could lead to endophthalmitis. The FDA also notes that the long-term effects of chronic electrical stimulation are unknown. Such effects may include deterioration of the retina or optic nerve. These effects may lead to deterioration of residual native vision and/or visual response to the Argus II System and could preclude subsequent replacement of the Argus II Implant with another retinal implant.



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