RETIRED Local Coverage Determination (LCD)

Implantable Miniature Telescope (IMT)

L33584

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.
Retired

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L33584
Original ICD-9 LCD ID
Not Applicable
LCD Title
Implantable Miniature Telescope (IMT)
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL33584
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 10/10/2019
Revision Ending Date
04/01/2024
Retirement Date
04/01/2024
Notice Period Start Date
09/16/2016
Notice Period End Date
10/31/2016
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Publications:

CMS Transmittal No. 2479, Publication 100-04, Medicare Claims Processing Manual, Change Request #7854, May 25, 2012, provides billing instructions for HCPCS codes C1840 and 0308T and the deletion of HCPCS code C9732 under the Ambulatory Surgery Center (ASC) Payment System.

CMS Transmittal No. 2481, Publication 100-04, Medicare Claims Processing Manual, Change Request #7844, June 1, 2012 includes CPT code 0308T for an insertion of an ocular telescope prosthesis including removal of crystalline lens which is effective for service performed on or after July 1, 2012.

CMS Transmittal No. 2483, Publication 100-04, Medicare Claims Processing Manual, Change Request #7847, June 8, 2012, provides billing instructions for HCPCS codes C1840 and 0308T and the deletion of HCPCS code C9732 under the Hospital Outpatient Prospective Payment System (OPPS).

CMS Transmittal No. 2378, Publication 100-04, Medicare Claims Processing Manual, Change Request #7682, December 29, 2011, provides billing instructions for HCPCS codes C1840 and C9732 under the Ambulatory Surgery Center (ASC) Payment System.

CMS Transmittal No. 2376, Publication 100-04, Medicare Claims Processing Manual, Change Request #7672, December 29, 2011, provides billing instructions for HCPCS codes C1840 and C9732 under the Hospital Outpatient Prospective Payment System (OPPS).

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Abstract:

The Implantable Miniature Telescope (IMT) is a telescope prosthetic device that replaces the natural lens in one eye of patients with bilateral, advanced age-related macular degeneration in order to enlarge the retinal image to such a degree that it is visualized outside of vision-impairing central scotomas.

After review of available peer-reviewed literature, National Government Services has determined that appropriate utilization of the IMT in patients who meet all of the indications detailed below may be payable by Medicare.

Indications:

The intraocular telescope is indicated for monocular implantation to improve vision in patients greater than or equal to 65 years of age with stable severe to profound vision impairment (best corrected distance visual acuity 20/160 to 20/800) caused by bilateral central scotoma associated with untreatable end-stage age-related macular degeneration.

Patients must:

  • Have retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by fluorescein angiography
  • Have untreatable end-stage, non-exudative, age-related macular degeneration
  • Have evidence of visually significant cataract (= Grade 2)
  • Agree to undergo pre-surgery training and assessment (typically 2 to 4 sessions) with low vision specialists in the use of an external telescope sufficient for patient assessment and for the patient to make an informed decision regarding the potential risks and benefits of the IMT
  • Achieve at least 5-letter improvement on the ETDRS chart with an external telescope during the pre-implant evaluation
  • Have adequate peripheral vision in the eye not scheduled for surgery
  • Complete and agree to the “Acceptance of risk and informed consent agreement” provided in the device labeling documentation
  • Agree to participate in post-implant visual training with a low vision specialist

Limitations:

Implantation of the intraocular telescope is contraindicated in patients:

  • with Stargardt’s macular dystrophy
  • with central anterior chamber depth (ACD) < 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
  • with the presence of corneal guttata
  • who do not meet the minimum age and endothelial cell density requirements (age 65 to < 70 min. cell density = 2300 cells/mm²; age 70 to < 75 min. cell density = 2000 cells/mm²; age 75 or greater min. cell density = 1800 cells/mm²)
  • with 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
  • who have evidence of active CNV on fluorescein angiography or treatment for CNV within the past six months
  • with any ophthalmic pathology that compromises the patient’s peripheral vision in the fellow eye
  • with previous intraocular or cornea surgery of any kind in the operative eye, including any type of surgery for either refractive or therapeutic purposes
  • who have prior or expected ophthalmic related surgery within 30 days preceding intraocular telescope implantation
  • with a history of steroid-responsive rise in intraocular pressure, uncontrolled glaucoma, or preoperative IOP > 22 mm Hg, while on maximum medication
  • with known sensitivity to post-operative medications
  • who have a history of eye rubbing or an ocular condition that predisposes them to eye rubbing
  • in whom the planned operative eye has:
    o Myopia > 6.0 D, Hyperopia > 4.0 D
    o Axial length < 21 mm
    o A narrow angle, i.e., < Schaffer grade 2
    o Cornea stromal or endothelial dystrophies, including guttata
    o Inflammatory ocular disease
    o Zonular weakness/instability of crystalline lens, or pseudoexfoliation
    o Diabetic retinopathy, untreated retinal tears, retinal vascular disease, history of retinal detachment, retinitis pigmentosa
    o Intraocular tumor
    o Optic nerve disease
  • In eyes in which both haptics cannot be placed within the capsular bag during surgery, the intraocular telescope should be removed and replaced with a conventional intraocular lens (IOL); sulcus fixation of either one or both haptics increases the risk of severe endothelial cell loss and corneal transplant
  • actively wet age-related macular degeneration (ARMD)

Other Comments:

The U.S. Food and Drug Administration (FDA) labeling specifies that a cornea specialist perform the IMT, because they are the ophthalmic surgical specialty with the additional surgical training required for advanced corneal procedures such as cornea transplants.

Prior to performing IMT, surgeons must participate in the required portion of the Physician Training Program provided by the device manufacturer.

National Government Services expects adequate follow-up of these patients (to include post-operative follow-up and rehabilitation services) to assure the best possible results for these patients. National Government Services anticipates this may require both short-term and long-term record review.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information
N/A
Sources of Information

This bibliography presents those sources that were obtained during the development of this policy. National Government Services is not responsible for the continuing viability of Web site addresses listed below.

Application for new device category for transitional pass-through payment status under the hospital outpatient prospective payment system. Executive Summary. VisionCare Ophthalmic Technologies, Inc. Saratoga CA.

Brown GC, Brown MM, Lieske HB, et al. Comparative effectiveness and cost-effectiveness of the implantable miniature telescope. Ophthalmology. 2011;118(9):1834-1843.

Chun DW, Heier JS, Raizman MB. Visual prosthetic device for bilateral end-stage macular degeneration. Expert Rev Med Devices. 2005;2:657-665.

Colby KA, Chang DF, Stulting RD, Lane SS. Surgical placement of an optical prosthetic device for end-stage macular degeneration: The Implantable Miniature Telescope. Arch Ophthalmol. 2007;125(8):1118-1121.

Garfinkel RA, Berinstein DM, Frantz R. Treatment of choroidal neovascularization through the implantable miniature telescope. Am J Ophthalmol. 2006;141:766-767.

Hudson HL, Lane SS, Heier JS, et al. 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, et al. 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, et al. A prospective multicenter clinical trial to evaluate the safety and effectiveness of the implantable miniature telescope. Am J Ophthalmol. 2004;137:993-1001.

Lane SS, Kuppermann BD. The implantable miniature telescope for macular degeneration. Curr Opin Ophthalmol. 2006;17:94-8.

Peli E. The optical functional advantages of an intraocular low vision telescope. Optom Vis Sci. 2002;79:225-233.

Primo SA. Implantable miniature telescope: lessons learned. Optometry. 2010;81:86-93.

Singer MA, del Cid MR, Stelton CR, Boord T. Pars plana posterior capsulotomy in a patient with a telescope prosthesis for age-related macular degeneration. Arch Ophthalmol. 2010;128(8):1065-1067.

U.S. Food and Drug Administration Labeling dated July 1, 2010. http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050034c.pdf. Accessed 01/03/2012.

U.S. Food and Drug Administration Approval Order dated July 1, 2010. http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050034a.pdf. Accessed 01/03/2012.

U.S. Food and Drug Administration News Release dated July 6, 2010. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm218066.htm. Accessed 12/29/2011.

U.S. Food and Drug Administration Premarket Approval (PMA) Supplement dated October 8, 2014.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=6756. Accessed 11/18/2014.

VisionCare™ Ophthalmic Technologies Implantable Miniature Telescope (by Dr. Issac Lipshitz) for End-Stage Macular Degeneration Indications for Use/Contraindications Document #10025096 Rev 2 11/2014.

Bibliography

N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
04/01/2024 R6

LCD L33584 is retired and is no longer in effect for services rendered on or after April 1, 2024. 

  • LCD Being Retired
10/10/2019 R5

Consistent with Change Request 10901, all coding information, National coverage provisions, and Associated Information (Documentation Requirements, Utilization Guidelines) have been removed from the LCD and placed in the related Billing and Coding Article, A57411. There has been no change in coverage with this LCD revision.

  • Revisions Due To Code Removal
11/01/2016 R4 This LCD was revised and returned to Jurisdiction 6 and Jurisdiction K for public and CAC comment from 06/30/2016 through 08/13/2016.

The limitations were revised to align with the contraindications in the latest manufacturer's document dated November 2014.

The latest manufacturer's document was added to the "Sources of Information and Basis for Decision" section.

ICD-10-CM code H35.32 along with the corresponding explanatory note was removed from the "ICD-10-CM Codes that Support Medical Necessity" section.

Due to the annual ICD-10-CM code update for 2017, ICD-10-CM code H35.31 was deleted from the "ICD-10-CM Codes that Support Medical Necessity" section of the LCD. ICD-10-CM codes H35.3114 and H35.3124 were added as the replacement codes.
  • New/Updated Technology
  • Revisions Due To ICD-10-CM Code Changes
01/01/2016 R3 The terminology for CPT code 0308T was revised.
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2015 R2 Minor template language change.
  • Other
10/01/2015 R1 Effective October 8, 2014, Food and Drug Administration (FDA) has lowered the telescope implant eligible age from 75 to 65 years of age. The indication has been revised to reflect this change. The updated Premarket Approval (PMA) Supplement dated October 8, 2014 was added to the “Sources of Information and Basis for Decision” section.
  • New/Updated Technology
N/A

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
04/01/2024 10/10/2019 - 04/01/2024 Retired You are here
10/04/2019 10/10/2019 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • Eye
  • Blindness

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