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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-V0000-02

Original Effective Date: 02/15/06

Reviewed: 12/01/11

Revised: 10/01/16

Subject: Implantation of Intrastromal Corneal Ring Segments

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Update  
           

DESCRIPTION:

Intrastromal corneal ring segments consist of micro-thin methylmethacrylate (plastic) inserts of variable thickness that are placed circumferentially into two-thirds depth of the peripheral corneal stroma. They have been investigated for two indications, a refractive surgery to correct mild myopia and as a treatment of keratoconus.

In myopia, the intrastromal inserts correct myopia by flattening the center of the cornea and represent an alternative to laser in situ keratomileusis (LASIK) and other refractive surgeries. The proposed advantages of the intrastromal corneal rings are that their insertion does not affect the central cornea and thus their effect is not related to the healing process in the cornea. No corneal tissue is removed, and the implants are reversible.

Keratoconus is a progressive bilateral dystrophy that is characterized by paracentral steepening and stromal thinning that impairs visual acuity. Initial treatment often consists of hard contact lenses. A penetrating keratoplasty (i.e., corneal grafting) is the next line of treatment in those patients who develop intolerance to contact lenses. While visual acuity is typically improved with a keratoplasty, perioperative complications is an associated risk, long-term topical steroid use is required, and endothelial cell loss occurs over time, which is a particular concern in younger patients. As an alternative, a variety of keratorefractive procedures have been attempted, broadly divided into subtractive and additive techniques. Subtractive techniques include photorefractive keratectomy or LASIK, but in general results of these techniques have been poor. Implantation of intrastromal corneal ring segments represents an additive technique in which the implants are intended to reinforce the cornea, prevent further deterioration, and potentially obviate the need for a penetrating keratoplasty. This technique has primarily been investigated in patients in whom the cornea has remained transparent and who are intolerant of contact lenses.

INTACS® represent an intrastromal corneal ring that has received approval by the U.S. Food and Drug Administration (FDA) for two indications. In 1999, INTACS® were approved through a premarket approval process (PMA) for the following labeled indication:

The KeraVision Intacs are intended for the reduction or elimination of mild myopia (-1.00 to -3.00 diopters spherical equivalent at the spectacle plane) in patients:

In 2004, INTACS® received an additional FDA approval through the Humanitarian Device Exemption (HDE) process for the following indication:

This device is indicated for the reduction or elimination of myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or spectacles, so that their functional vision may be restored and the need for a corneal transplant procedure may potentially be deferred. The specific set of keratoconic patients proposed to be treated with INTACS® prescription inserts are those patients:

NOTE: The humanitarian device exemption (HDE) does not require the manufacturer to provide data confirming the efficacy of the device, but rather data supporting its “probable” benefit. The HDE process is available for devices treating conditions that affect less than 4,000 Americans per year.

POSITION STATEMENT:

NOTE: All refractive eye surgeries are generally contract exclusions; therefore implantation of intrastromal corneal ring segments is not covered for the treatment of myopia.

Implantation of intrastromal corneal ring segments for the treatment of keratoconus meets the definition of medical necessary when ALL of the following criteria are met:

• Patient is 21 years of age or older; AND

• There is progressive deterioration in the patient’s vision, such that he/she can no longer achieve adequate functional vision with contact lenses or spectacles; AND

• Corneal transplantation is the only alternative to improve the patient’s functional vision; AND

• There is a clear central cornea with a corneal thickness of 450 microns or greater at the proposed incision site.

BILLING/CODING INFORMATION:

CPT Coding

65785

Implantation of intrastromal corneal ring segments

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Noncovered Services (L33777), located at fcso.com.

DEFINITIONS:

Cornea: responsible for focusing light rays to the back of the eye.

Corneal stroma: middle layer of the cornea.

INTACS (intracorneal rings): a corneal ring prescription insert that can be removed or replaced. Vision correction with INTACS entails implanting the micro-thin intracorneal rings into the cornea and they produce a reshaping of the curvature of the cornea (reducing low degrees of myopia [nearsightedness].

Keratoconous: thinning of the cornea causing a cone-shaped bulging of the cornea, usually bilaterally; can by corrected by glasses, contact lenses, or surgery.

Myopia: near-sightedness; a condition of the eye in which images are formed in front of the retina, resulting in a blurred image nearsightedness.

Ocular implants: composed of tiny transparent crescents that can be implanted in the periphery of the cornea, resulting in a flattening of the cornea. The ocular implants, called KeraVision INTACS (Intracorneal rings), are designed to treat mild myopia and astigmatism. The implants, although considered permanent, can be removed if complications develop.

RELATED GUIDELINES:

Keratoplasty, 02-65000-15
Prosthetic Eyes and Lens Implants, 09-V0000-01

OTHER:

Other indexing terms:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Corneal ring segments
INTACS®
Keratoconus
Keravision
Myopia

REFERENCES:

  1. American Medical Association CPT coding (current edition).
  2. Blue Cross Blue Shield Association Medical Reference Manual Policy 9.03.14 Implantation of Intrastromal Corneal Ring Segments, (09/01/11).
  3. ClinicalTrials.gov. Intacs for keratoconus. NCT 00347230.
  4. First Coast Service Options (FCSO) Local Coverage Determination (LCD). The List of Noncovered Services L5780, (09/05/11).
  5. Kubaloglu, Anl MDı; Sari, Esin Sogutlu MD; Cinar, Yasin MD; Koytak, Arif MD; Kurnaz, Ekrem MD; Özertürk, Yusuf MD. Intrastromal Corneal Ring Segment Implantation for the Treatment of Keratoconus. Cornea: January 2011 - Volume 30 - Issue 1 - pp 11-17
  6. Maguen E, Rabinowitz YS, Regev L, et al. Alterations of Extracellular Matrix Components and Proteinases in Human Corneal Buttons with Intacs for Post-Laser In Situ Keratomileusis Keratectasia and Keratoconus. Cornea 2009 June; 27(5):565-573.
  7. Rapuano CJ, Sugar A, Koch DD, Agapitos PJ, Culbertson WW, de Luise VP, Huang D, A Varley GA. Intrastromal corneal ring segments for low myopia: a report by the American academy of ophthalmology. Ophthalmology; Volume 108, Issue 10 , Pages 1922-1928, October 2001 (maintained 2009)
  8. Shetty, R, Kannan N, et al. Safety and efficacy of Intacs in Indian eyes with keratoconus: An initial report. Indian J Ophthalmol: 2009;57:115-119.
  9. Siganos CS, et al. Management of Keratoconus with Intacs. Am J of Ophthalmol. Jan 2003;135:1.
  10. Tan, BU, Purcell TL, Torres LF, Schanzlin DJ. New Surgical Approaches to the Management of Keratoconus and Post-Lasik. Trans Am Ophthalmol Soc. Vol 104; 2006: 212-220.
  11. U.S. Food and Drug Administration (FDA); Consumer Information – INTACS® Prescription Inserts for Keratoconus – H040002, (accessed at FDA website 04/05).

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 12/01/11.

GUIDELINE UPDATE INFORMATION:

02/15/06

New Medical Coverage Guideline.

02/15/07

Scheduled review; no change in coverage statement.

06/15/07

Reformatted Medical Coverage Guideline.

02/15/08

Scheduled review; no change in position statement; references updated.

02/15/09

Scheduled review; no change in position statement; references updated.

02/15/10

Scheduled review with literature search; position statement change; coverage criteria added; references updated.

12/15/11

Scheduled review; position statement unchanged; references updated; related ICD-9 and ICD-10 diagnosis codes added: formatting changes.

11/01/15

Revision: ICD-9 Codes deleted.

01/01/16

Annual CPT/HCPCS coding update. Added code 65785. Deleted code 0099T. Revised Program Exceptions section.

10/01/16

Revision: Billing/Coding Information section updated.

Date Printed: June 24, 2017: 11:29 AM