Coverage Policy Manual
Policy #: 2010034
Category: Surgery
Initiated: November 2010
Last Review: September 2018
  Implantable Telescope for the Treatment of Age-Related Macular Degeneration

Description:
Age-related macular degeneration (AMD) is a leading cause of irreversible, severe loss of vision in developed countries.  In the United States, AMD causes approximately 46% of cases of severe visual loss in persons over 40 years of age.  Age-related macular degeneration 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.
 
VisionCare has received FDA approval for their implantable telescope (The Implantable Miniature Telescope by Dr. Isaac Lipshitz).  The Implantable telescope is housed in a glass cylinder 4.4mm long and 3.6mm in diameter.  It is surgically implanted in the capsular bag after removal of the lens and is held in position by haptic loops.  The implant enlarges images approximately 2.2 or 2.7 times their normal size depending on the model used. The magnification allows for central images to be projected onto healthy areas of the retina surrounding the damaged macular area allowing the patient to distinguish and discern images that may have been previously unrecognizable.
 
The patient must be managed preoperatively and postoperatively by a team of healthcare professionals usually consisting of a retinal specialist, a surgeon, an optometrist and a low vision occupational therapist. After surgery, visual rehabilitation is necessary for the patient to learn to use their new vision in activities of daily living.
 
The FDA approved labeling indicates that this device should be implanted only by cornea specialists (an ophthalmologist who had fellowship or other specialty training in diseases and surgery of the cornea and who regularly performs cornea surgical procedures).
 
Effective 1/31/2013, there is a specific CPT Category III Code for this procedure:
CPT 0308T: Insertion of ocular telescope prosthesis including removal of crystalline lens.
 
Prior to 2013, the unlisted CPT code 67299 may have been used.
 

Policy/
Coverage:
The Implantable Miniature Telescope meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL of the following criteria are met:
 
 The patient:
 
    • Is 75 years of age or older.
    • Has irreversible, End-Stage AMD resulting from either dry or wet AMD.
    • Severe to profound bilateral vision impairment (BCVA 20/160 to 20/800).
    • Evidence of visually significant cataract (Grade 2 or greater).
    • Has retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by fluorescein angiography.
    • Must be able to achieve at least a 5-letter improvement on the ETDRS chart with an external telescope.
    • Must have adequate peripheral vision in the eye not scheduled for surgery.
    • Must agree to pre-surgery training and assessment (typically 2 to 4 sessions) with low vision specialists (ophthalmologists, optometrist or occupational therapist) in the use of an external telescope sufficient for patient assessment and for the patient to make an informed decision.
    • Must agree to participate in post-operative training with a low vision specialist (ophthalmologist, optometrist or occupational therapist).
 
The patient must not have ANY of the following:
 
    • Stargardt’s macular dystrophy.
    • Central anterior chamber depth (ACD) less than 3.0 mm; measurement of the ACD should be taken from the posterior surface of the cornea (endothelium) to the anterior surface of the crystalline lens.
    • Presence of corneal guttata.
    • Endothelial cell density less than 2000/mm² (ages 75-84) or less than 1800/mm² (ages 85 or greater).
    • Cognitive impairment that would interfere with the ability to understand and complete the Acceptance of Risk and Informed Decision Agreement or prevent proper visual training/rehabilitation with the device.
    • Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or treatment for CNV within the past six months.
    • Any ophthalmic pathology that compromises the patient’s peripheral vision in the fellow eye.
    • Previous intraocular or cornea surgery of any kind in the operative eye, including any type of surgery for either refractive or therapeutic purposes.
    • Prior or expected ophthalmic related surgery within 30 days preceding intraocular telescope implantation.
    • History of steroid-responsive rise in intraocular pressure, uncontrolled glaucoma, or preoperative IOP>22mmHg, while on maximum medication.
    • Known sensitivity to post-operative medications.
    • History of eye rubbing or an ocular condition that predisposes them to eye rubbing.
    • In the planned operative eye: myopia greater than 6.0 D; hyperopia greater than 4.0 D; axial length less than 21 mm; a narrow angle (i.e., less than Schaffer grade 2); cornea stromal or endothelial dystrophies, including guttata; inflammatory ocular disease; zonular weakness/instability of crystalline lens, or pseudoexfoliation; diabetic retinopathy; untreated retinal tears; retinal vascular disease; optic nerve disease; history of retinal detachment; intraocular tumor; or retinitis pigmentosa.
 
The implanting physician:
 
    • Must participate in the required portion of the Physician Training Program provided by VisionCare.
 
 
Use of the Implantable Miniature Telescope for any other indication does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For contracts without primary coverage criteria, the use of the Implantable Miniature Telescope for any other indication is considered investigational.  Investigational services are contract exclusions in most member benefit certificates of coverage.
 

Rationale:
A search of the MEDLINE database revealed three published studies assessing the safety and efficacy of the implantable miniature telescope. In the IMT-002 study, investigators from 28 U.S. sites enrolled 217 patients with age-related macular degeneration to assess the safety and effectiveness of the implantable miniature telescope (Hudson, 2006).  The primary outcome measurement was an increase of 2 or more lines of best-corrected distance visual acuity (BCDVA) or best-corrected near visual acuity (BCNVA) at 12 months.
 
Out of the 217 patients enrolled, only 206 patients had surgical implantation of the IMT.  Eleven patients were not implanted due to surgical complications involving posterior capsule tears, choroidal detachment, zonular dehiscence and choroidal hemorrhage. In addition, 2 patients required removal of the telescope 1 month after implant due to condensation inside the telescope cylinder. Other significant complications included corneal edema, iris damage, vitreous loss and increased intraocular pressure. In addition, endothelial cell density (ECD) was reduced by 20% at 3 months and 25% at 1 year.
 
At 1 year, 90% of the implanted eyes achieved a 2-line improvement in BCDVA or BCNVA and a 3-line or more improvement was seen in 87% of implanted eyes (Hudson, 2006). At two years, (Hudson, 2008) data from 174 of the original 206 patients was analyzed.  Improvement in best-corrected visual acuity (BCVA) of 3 or more lines was seen in 103 (59.5%) implanted eyes compared to only 18 (10.3%) of fellow eye controls. At two years, the rate of endothelial cell loss was much lower (2.4%) compared to the 25% reduction seen at 1 year.
 
The U.S. Food and Drug Administration’s Summary of Safety and Effectiveness Data for the Implantable Miniature Telescope indicates that a portion of the patients (N=129) from the IMT-002 study were enrolled into a 5 yr follow-up study.  The results of this study have not been published.  This study will continue an additional 2 years as a condition of the FDA approval of the device.
 
The pilot study enrolled 15 patients aged 60 or older with age-related macular degeneration, cataract and BCVA between 20/80 and 20/400 (Lane, 2004). Fourteen patients had the intraocular telescope implanted. One implantation was not successful because of a capsular tear during removal of the cataract.  At one year, 77% of the patients gained 2 or more lines of BCVA and 62% gained 3 or more lines of BCVA. Endothelial cell density was decreased by a mean of 13%.   
 
The available literature indicates that the implantable telescope can improve health outcomes in patients with age-related macular degeneration with severe to profound vision impairment.  However, due to the risk of corneal endothelial cell loss which may lead to corneal edema and the subsequent need for corneal transplant, the patient must meet very specific criteria and must undergo adequate training and assessment pre- and post-operatively.
 
2012 Update
A search of the MEDLINE database through August 2012 did not reveal any new information to prompt a change in the coverage statement.
 
2014 Update
A literature search was conducted using the MEDLINE database through August 2014. There was no new literature identified that would prompt a change in the coverage statement.
 
2015 Update
A literature search conducted through August 2015 did not reveal any new information that would prompt a change in the coverage statement.    
 
2016 Update
A literature search conducted through August 2016 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search was conducted through August 2018.  There was no new information identified that would prompt a change in the coverage statement.  

CPT/HCPCS:
0308TInsertion of ocular telescope prosthesis including removal of crystalline lens or intraocular lens prosthesis
66999Unlisted procedure, anterior segment of eye

References: Colby KA, Chang DF, Stulting RD, Lane SS.(2007) Surgical placement of an optical prosthetic device for end-stage macular degeneration: The Implantable Miniature Telescope. Arch Ophthalmol. 2007;125:1118-21.

Hudson HL, Lane SS, Heier JS, Stulting RD, Singerman L, Lichter PR, Sternberg P, Chang DF.(2006) Implantable miniature telescope for the treatment of visual acuity loss due to end-stage age-related macular degeneration: one-year results. Ophthalmology. 2006;113:1987-2001.

Hudson HL, Stulting RD, Heier JS, Lane SS, Chang DF, Singerman LJ, Bradford CA, Leonard RE.(2008) IMT002 Study Group. Implantable Telescope for End-Stage Age-related Macular Degeneration: Long-term Visual Acuity and Safety Outcomes. Am J Ophthalmol. 2008:146;664-673.

Lane SS, Kuppermann BD, Fine IH, Hamill MB, Gordon JF, Chuck RS, Hoffman RS, Packer M, Koch DD.(2004) A prospective multicenter trial to evaluate the safety and effectiveness of the implantable miniature telescope. Am J Ophthalmol 2004;137:993-1001.

Lane, SS, Kuppermann, BD.(2006) The Implantable Miniature Telescope for macular degeneration. Ophthalmol. 2006;17:94-8.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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