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Medical Policy: 09.03.09
Original Effective Date: October 2008
Reviewed: April 2012
Revised: October 2008
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Intrastromal corneal ring segments consist of micro-thin methylmethacrylate inserts of variable thickness that are placed circumferentially into two-thirds depth of the peripheral corneal stroma. They have been investigated for two indications, 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 patients who develop intolerance to contact lenses. While visual acuity is typically improved with keratoplasty, perioperative complications are 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 2 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:
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Who are 21 years of age or older;
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With documented stability of refraction as demonstrated by a change of less than or equal to 0.50 diopter for at least 12 months prior to the preoperative examination; and
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Where the astigmatic component is +1.00 diopter or less.”
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:
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Who have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles;
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Who are 21 years of age or older;
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Who have clear central corneas;
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Who have a corneal thickness of 450 microns or greater at the proposed incision site; AND
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Who have corneal transplantation as the only remaining option to improve their functional vision.”
Note: 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 fewer than 4,000 Americans per year.
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Prior Approval:
Not applicable
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Policy:
Implantation of FDA approved intrastromal corneal rings may be considered medically necessary for keratoconus patients who meet all of the following criteria:
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21 years of age or older; AND
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Have experienced a progressive deterioration in vision, such as can no longer achieve adequate functional vision on a daily basis with contact lenses or glasses; AND
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Have clear central corneas; AND
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Have a corneal thickness of 450 microns or greater at the proposed incision site; AND
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Corneal transplantation as the only remaining option to improve functional vision.
Implantation of intrastromal corneal ring segments is considered not medically necessary as a treatment of myopia when performed solely to eliminate the use of refractive lenses (eye glasses or contacts).
Intrastromal corneal ring implants are considered investigational for all other conditions and applications.
Also see the separate policies regarding phototherapeutic keratectomy, policy 09.03.05, and refractive keratoplasty, policy 09.03.06
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Procedure Codes and Billing Guidelines:
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To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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0099T implantation of intrastromal corneal ring segments
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Selected References:
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ECRI. Intrastromal Corneal Ring Segments (Intacs Prescription Inserts) for Keratoconus. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2008 October 23. 11p (ECRI Hotline Response). Also available: http://www.ecri.org.
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ECRI. Intrastromal Corneal Ring Segments (Intacs Prescription Inserts) for Refractive Errors. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2008 October 23. 12p (ECRI Hotline Response). Also available: http://www.ecri.org.
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Colin J Malet FJ. Intacs for the correction of keratoconus: two-year follow-up. J Cataract Refract Surg 2007; 33(1):69-74.
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Samimi S, Leger F, Touboul D et al. Histopathological findings after intracorneal ring segment implantation in keratoconic human corneas. J Cataract Refract Surg 2007; 33(2):247-53.
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Kymionis GD, Siganos CS, Tsiklis NS et al. Long-term follow-up of Intacs in keratoconus. Am J Ophthalmol 2007; 143(2):236-44.
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Policy History:
Date Reason Action
April 2011 Annual review Policy renewed
April 2012 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
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affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.
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