LCD/NCD Portal

L32822

 

IMPLANTABLE MINIATURE TELESCOPE (IMT)

 

10/09/2012

 

Indications and Limitations of Coverage and/or Medical Necessity

• After consideration of comments received from various experts in the field, and in order to give access to care to beneficiaries who may otherwise not have any other treatment options, limited coverage will be allowed for

o Patients with untreatable end-stage age-related macular degeneration.

o Who meet all of the indications as outlined below for the utilization of the IMT.

 

• Indications of Coverage:

 

o The intraocular telescope is indicated for

o monocular implantation to improve vision in patients

o who are greater than or equal to 75 years of age

o with stable severe to profound vision impairment (best corrected distance visual acuity 20/160 to 20/800)

o caused by bilateral central scotomas (blind areas)

o Associated with the untreatable end-stage age-related macular degeneration.

• In order for the IMT to be covered by Medicare, patients must meet all of the following indications:

o Have untreatable end-stage non-exudative age-related macular degeneration

o Have retinal findings of disciform scar with foveal involvement or geographic atrophy as determined by a fluorescein angiography

o Have evidence of a visually significant cataract that’s greater than or equal to Grade 2

o Agree to undergo pre-surgery training and assessment (usually 2 to 4 sessions) with a low vision specialists in the use of an external telescope that’s sufficient for patient assessment and for the patient to make an informed decision about the potential benefits and risks of the implantable miniature telescope

o Achieve at least a 5-letter improvement on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart with an external telescope during the pre-implant evaluation

o Have an adequate peripheral vision in the eye that is not scheduled for surgery

o Complete and agree to the “Acceptance of Risk and Informed Consent Agreement” that’s provided in the device labeling documentation

o Agree to participate in a post-operative visual training with a low vision specialist

 

• Limitations of Coverage:

o Due to a significantly increased risk of corneal endothelial cell loss, patients should not be considered for the implantation of the device if they have a minimum endothelial cell density of less than 2000 for 75-84 years of age, or less than 1800 for patients 85 or greater years of age, or

o Anterior chamber depths of less than 3.0 mm, or

o Presence of corneal guttata (appear as dark spots on the corneal endothelium)

 

• Additional limitations of coverage include the following:

o Only a cornea specialist should implant the IMT as they are the ophthalmic surgical specialty who has the additional surgical training that is required to perform corneal surgical procedures such as penetrating keratoplasty.

o Surgeons must participate in the required portion of the Physician Training Program provided by the device manufacturer before the implantation of the miniature telescope prosthesis.

o Adequate follow-up with the patient is expected (includes post-operative follow-up and rehabilitation services) after implantation of the device to ensure the best possible results for the patient. It is expected that this may require both short-term and long-term record review.

 

CPT/HCPCS Codes

 

 

Note: HCPCS code C1840 must be billed with CPT code 0308T; and HCPCS code C1840 should be billed by Ambulatory Surgical Centers (ASCs) only.

0308T INSERTION OF OCULAR TELESCOPE PROSTHESIS INCLUDING REMOVAL OF CRYSTALLINE LENS

C1840 LENS, INTRAOCULAR (TELESCOPIC)

 

 

Documentation Requirements

• Medical record documentation maintained by the performing provider must clearly indicate the medical necessity of the services being billed as outlined under the “Indications and Limitations of Coverage and/or Medical Necessity” section of this LCD and made available to Medicare upon request.

• In addition, documentation that the service was performed must be included in the patient’s medical record and should be legible.

• This information is normally found in the history and physical, office/progress notes, and/or procedure report.

 

Treatment Logic

 

• The Implantable Miniature Telescope (IMT) is an intraocular telescopic prosthesis that replaces the natural lens in only one of the patient’s eyes due to bilateral advanced age-related macular degeneration.

• The telescope prosthesis enlarges the central vision images over a large portion of the retina to improve the patient’s central vision which helps to reduce the blind areas caused by vision-impairing central scotomas.

 

Sources of Information and Basis for Decision

 

Colby, K.A., Chang, D.F., Stulting, R.D., & Lane, S.S. Surgical placement of an optical prosthetic device for end-stage macular degeneration: the implantable miniature telescope. Archives of Ophthalmology. 2007;125(8):1118-1121. Retrieved from http://archopht.ama-assn.org/cgi/content/full/125/8/1118.

 

Hudson, H.L., Stulting, R.D., Heier, J.S., Lane, S.S., Chang, D.F., Singerman, L.J., Bradford, C.A., & Leonard, R.E., IMT002 Study Group. Implantable Telescope for End-Stage Age-Related Macular Degeneration. Long-Term Visual Acuity and Safety Outcomes. American Journal of Ophthalmology. 2008;146:664-673.

 

Hudson, H.L., Lane, S.S., Heier, J.S., Stulting, R.D., Singerman, L., Lichter, P.R., Sternberg, P., & Chang, D.F. 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. Retrieved from http://www.changcataract.com/pdfs/imt_1_yr_results.pdf.

 

“Implantable Miniature Telescope (IMT),” NHIC Corp. Local Coverage Determination (LCD) (14102), L32275.

 

Primo, S.A. Implantable miniature telescope: lessons learned. Optometry. 2010; 81:86-93. Retrieved from http://www.natoptassoc.org/pdf/IMT%20published.pdf.

 

Singer, M.A., Amir, N., Herro, A., Porbandarwalla, S.S., & Pollard, J. Improving quality of life in patients with end-stage age-related macular degeneration: focus on miniature ocular implants. Clinical Ophthalmology. 2012; 6:33-39. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3259097/pdf/opth-6-033.pdf.

 

The Cornea Research Foundation: Corneal Conditions-Fuchs’ Dystrophy. Retrieved from http://www.cornea.org/index.php/research/corneal_conditions/fuchs_dystrophy/

 

U.S. Food and Drug Administration (FDA). Implantable Miniature Telescope™ - P050034 approval order, summary, and labeling information issued July 1, 2010. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P050034.

 

U.S. Food and Drug Administration (FDA). FDA approves first implantable miniature telescope to improve sight of AMD patients. FDA News Release. July 6, 2010. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm218066.htm.

 

VisionCare Ophthalmic Technologies, Inc. VisionCare’s implantable miniature telescope (by Dr. Isaac Lipshiz): an intraocular telescope for treating severe to profound vision impairment due to bilateral end-stage age-related macular degeneration. Professional Use Information. Saratoga, CA: VisionCare Ophthalmic Technologies; 2010. Retrieved from http://www.centrasight.com/HCP_Important_Safety_Information.

 

10/09/2012

The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

CMS LCD L32822 Implantable Miniature Telescope (IMT)