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DESCRIPTIONIntrastromal corneal ring segments consist of micro-thin soft plastic inserts of variable thickness that are placed in the periphery of the cornea. Intrastromal corneal ring segments have been investigated as a means of improving vision in diseases such as keratoconus and pellucid marginal degeneration, and for refractive surgery to correct mild myopia and astigmatism following penetrating keratoplasty (PK).
Intrastromal corneal ring segments consist of microthin soft plastic inserts of variable thickness that are placed in the periphery of the cornea. An incision is made in the cornea and channels are created in it by rotating a lamellar dissector or by using a femtosecond laser. One or two corneal implant segments are introduced to each channel, and various implants with a range of implant thicknesses are available for different degrees of correction. They affect refraction in the eye by physically changing the shape of the cornea (flattening the front of the eye), thereby correcting the irregular corneal shape. If required, the implants can be removed at a later date. Intrastromal corneal ring segments have been investigated as a means of improving vision in diseases such as keratoconus and pellucid marginal degeneration, and for refractive surgery to correct mild myopia.
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) was traditionally considered the next line of treatment in patients who developed 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 laser in situ keratomileusis (LASIK), but in general, results of these techniques have been poor. In deep anterior lamellar keratoplasty, pathologic corneal stromal tissue is selectively removed to the level of the Descemet membrane; followed by transplantation of a donor graft. 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.
Pellucid marginal degeneration is a noninflammatory progressive degenerative disease, typically characterized by bilateral peripheral thinning (ectasia) of the inferior cornea. Deterioration of visual function results from the irregular astigmatism induced by asymmetric distortion of the cornea, and visual acuity typically cannot be restored by using spherocylindrical lenses. Rigid gas permeable contact lenses may be used to treat pellucid marginal degeneration. Intracorneal ring segment implantation, crescentic lamellar keratoplasty, penetrating keratoplasty, and corneal wedge excision have also been proposed.
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. However, mild myopia is effectively treated with either spectacles or contact lenses.
Intacs® represents an intrastromal corneal ring that has received approval by the U.S. Food and Drug Administration (FDA) for two indications:
In 1999, Intacs inserts were approved by FDA 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 manufacturers to provide data confirming the efficacy of a 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.
POLICYImplantation of intrastromal corneal ring segments may be considered medically necessary for the treatment of keratoconus in patients 21 years of age or older who meet the following criteria:
Implantation of intrastromal corneal ring segments is considered not medically necessary as a treatment of myopia.
Implantation of intrastromal corneal ring segments is considered investigational for all other conditions.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY7/21/2005: Approved by Medical Policy Advisory Committee (MPAC)
1/10/2008: Policy reviewed, no changes
05/28/2010: Policy description updated regarding treatment approaches. Policy statement revised to add that this procedure may be medically necessary in specified conditions. Based on the new statement, moved 0099T from non-covered to covered and added ICD-9 codes 371.60 - 371.62. FEP verbiage added to the Policy Exceptions section.
10/21/2010: Policy reviewed; no changes.
12/01/2011: Policy reviewed; no changes.
11/30/2012: Policy reviewed; no changes.
11/15/2013: Policy reviewed; no changes.
10/15/2014: Policy reviewed; description updated regarding pellucid marginal degeneration. Policy statement unchanged.
08/18/2015: Medical policy revised to add ICD-10 codes.
11/10/2015: Policy description updated regarding mild myopia. Policy statements unchanged. Policy guidelines updated to add medically necessary and investigative definitions.
SOURCE(S)Blue Cross Blue Shield Association policy # 9.03.14
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.