The term refractive surgery describes various procedures to correct refractive errors of the eye. This document addresses refractive surgeries.

Note: For information concerning related topics, see:

• SURG.00061 Presbyopia-Correcting Intraocular Lenses;
• SURG.00108 Endothelial Keratoplasty;
• SURG.00115 Keratoprosthesis.

Medically Necessary:

Correction of surgically induced astigmatism with a corneal relaxing incision or corneal wedge resection is considered medically necessary when all of the following criteria are met:

1. The astigmatism is the result of a previous cataract surgery, medically necessary refractive surgery, scleral buckling for retinal detachment, or corneal transplant; AND
2. The degree of astigmatism is 3.00 diopters or greater; AND
3. The medical record documents inadequate functional vision with any of the following: (a) contact lenses, (b) spectacles, or (c) contact lenses and spectacles.

Laser in situ keratomileusis (LASIK), laser epithelial keratomileusis (LASEK), photorefractive keratectomy (PRK), and photoastigmatic keratectomy (PARK or PRK-A) are considered medically necessary when all of the following are met:

1. Prior cataract, corneal, or scleral buckling surgery for retinal detachment has been performed on this eye; AND
2. The medical record documents symptoms due to aniseikonia (different sizes of ocular images) or anisometropia (difference in power of refraction); AND
3. The medical record documents inadequate functional vision with any of the following: (a) contact lenses, (b) spectacles, or (c) contact lenses and spectacles; AND
4. The post-operative spherical equivalent refractive error has changed by 3 diopters when compared to the preoperative refractive error or the degree of astigmatism is 3 diopters or greater.

Epikeratoplasty (epikeratophakia) is considered medically necessary for either of the following conditions:

1. Correction of refractive errors of acquired or congenital aphakia; OR
2. Hypermetropia following cataract surgery in individuals unable to receive intraocular lens.

Implantation of intrastromal corneal ring segments (i.e., INTACS^™ Addition Technology, Sunnyvale, CA) is considered medically necessary in individuals with keratoconus who meet all of the following criteria:

1. Progressive deterioration in vision, such that individuals can no longer achieve adequate functional vision on a daily basis with either contact lenses or spectacles; AND
2. 21 years of age or older; AND
3. Presence of clear central cornea; AND
4. Corneal thickness of 450 microns or greater at the proposed incision site; AND
5. Who have corneal transplantation as the only remaining option to improve their functional vision.

Not Medically Necessary: 

Procedures considered not medically necessary include, but are not limited to, the following:

1. Correction of surgically induced astigmatism with a corneal relaxing incision or corneal wedge resection, except for the small subset of individuals noted above;
2. Laser in situ keratomileusis (LASIK), except for the small subset of individuals noted above;
3. Laser epithelial keratomileusis (LASEK), except for the small subset of individuals noted above;
4. Epikeratoplasty (epikeratophakia), except for the small subset of individuals as noted above;
5. Laser thermal keratoplasty (LTK);
6. Photorefractive keratectomy (PRK) and photoastigmatic keratectomy (PARK or PRK-A), except for the small subset of individuals noted above;
7. Radial keratotomy and its variants;
8. Implantable contact lenses without lens extraction (phakic intraocular lenses) including, but not limited to, Artisan^® Phakic Intraocular Lens also known as Veriaye^™ Phakic Intraocular Lens (Ophtec USA, Inc., Boca Raton, FL) and Visian ICL^™ Implantable Collamer Lens (Starr Surgical Company, Monravia, CA);
9. Clear lens extraction (CLE) with or without implantation of an accommodating or nonaccommodating lens;
10. Implantation of intrastromal corneal ring segments (i.e., INTACS) for the correction of myopia;
11. Conductive keratoplasty to treat presbyopia (i.e., ViewPoint^™ CK System [Refracrtec Inc., Irvine, CA]);
12. Keratophakia;
13. Orthokeratology;
14. Standard keratomileusis.

Refractive Eye Surgery
Refractive eye surgery includes several procedures designed to eliminate or reduce the need for glasses or contact lenses by reshaping the curve of the cornea or implanting an intraocular lens. Other alternatives include conductive keratoplasty (CK), a treatment for presbyopia which uses radiofrequency energy to bend the cornea, and laser thermal keratoplasty (LTK), a treatment of hyperopia which uses a holmium: YAG laser applied to the periphery of the cornea.  Conductive keratoplasty has received U.S. Food and Drug Administration (FDA) approval as a treatment of presbyopia. Implantation of phakic intraocular lenses (IOLs) is another option; the Artisan phakic intraocular lens (PIOL) and the Visian ICL have received FDA approval for the reduction or elimination of myopia. Intraocular lens implants (clear lens extraction) have been used for the correction of presbyopia, hyperopia and myopia. Intra-stromal corneal ring segments consist of micro-thin methylmethacrylate inserts of variable thickness that are placed circumferentially into the peripheral corneal stroma at two-thirds depth. They have been investigated for two indications, a refractive surgery to correct mild myopia and as a treatment of keratoconus. While a wide variety of surgeries have been investigated for the correction of mild to moderate refractive errors (i.e. radial keratotomy and its variants, photorefractive keratectomy), these procedures have been largely superseded by LASIK, which has emerged as the most commonly performed refractive procedure.

The use of refractive eye surgery as an alternative to eyeglasses or contact lenses is considered to be predominately for comfort and convenience. A medical rationale for refractive surgery must rest on the demonstration that refractive surgery results in a clinically significant improvement in vision as compared to that achieved with eyeglasses or contact lenses. The available peer-reviewed literature has failed to establish the superiority of refractive surgical procedures in terms of safety and long term benefit over conventional eyewear including glasses and contact lenses for those indications listed as not medically necessary.

Keratoconus
In 2004, INTACS received an 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 individuals 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 individuals proposed to be treated with INTACS prescription inserts are those:

• 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 and
• Who are 21 years of age or older and
• Who have clear central cornea and
• Who have a corneal thickness of 450 microns or greater at the proposed incision site and
• Who have corneal transplantation as the only remaining option to improve their functional vision.

The published data regarding intrastromal corneal implants for keratoconus consist of single institution case series.  Boxer Wachler and colleagues (2003) reported on the outcomes in 74 eyes of 50 subjects with a mean follow-up of 9 months.  A total of 45% gained at least 2 lines of best spectacle corrected visual acuity (BSCVA), 51% of individuals had no change, and 4% lost BSCVA. Siganos and colleagues (2003) studied 33 eyes in 26 individuals at a mean follow-up of 11.3 months. In this study, 25 eyes recorded a 1- to 6-line gain in BSCVA, while 4 eyes remained unchanged and 4 eyes experienced a loss. Colin and colleagues (2001) reported the 1-year results in a series of 10 individuals.  The mean values for BSCVA improved progressively over time, and at the 12-month follow-up, average visual acuity was 2 lines better than baseline. Alio and colleagues (2006) reported the outcomes of 13 eyes with a follow-up of 36 months in all eyes. Mean best BSCVA increased from 0.46 (20/50) preoperatively to 0.66 (20/30) postoperatively (P< or =.001). Colin and Malet (2007) reported outcomes of a two year follow-up study comprised of 100 eyes after INTACS implantation.  At two years, the uncorrected visual acuity (UCVA) and BCVA improved in 80.5% and 68.3% of eyes, respectively (P<.001). The proportion of eyes with a BCVA greater than or equal to 0.5 (20/40) increased from 22.0% at baseline to 51.2% and 53.7% at 1 year and 2 years, respectively (P<.001).  Contact lens tolerance was restored in over 80% of cases.

Description of Refractive Eye Conditions

Refractive errors, occurring in approximately 50% of the United States population, are disorders of the eye whereby objects, either distant, close or both, appear blurred. Refraction is the bending of light rays as they move from one transparent medium to another medium of a different density and is measured in diopters. The cornea, along with the lens, refracts light that enters the eye. Specifically, the cornea is responsible for 2/3 of the eye's total focusing power and this power is fixed – meaning that it does not change its shape to bring an object into focus. As an eye with normal vision views an object, the cornea and the lens focus the parallel light rays emitted from the object precisely on the retina and a clear image is perceived. In myopia, the most common type of refractive error (occurring in approximately 25% of individuals), the cornea is too curved or the lens too powerful for the length of the globe. Distant objects cannot be seen clearly but near objects appear clear.  In hyperopia (farsightedness) the cornea is too flat or the lens too weak for the length of the globe. As a result, a distant object will appear in focus, while near vision is unclear. Presbyopia is an age related visual change, which begins between 40 and 50 years of age and results in difficulty with visual accommodation and thus objects which are nearby are blurred. In astigmatism, the refractive power of the eye is in different meridians. As a result, objects appear blurry at any distance; this can occur with myopia or hyperopia.  Refractive errors are temporarily corrected by wearing eyeglasses or contact lenses; however, once the glasses or contacts are removed, blurred vision returns.

Functional Description

Refractive surgery has emerged as an option to permanently eliminate the use of glasses or contact lenses.  The goals of refractive surgery are to reduce or eliminate refractive error, attain normal vision, and reduce or eliminate the need for glasses or contact lenses for distant vision through the incision or excision of corneal tissue by a surgical instrument. Refractive keratoplasty is a generic term, which includes all surgical procedures on the cornea to improve vision by changing the refractive index of the corneal surface, although they involve different methods.  Refractive procedures include the following surgeries:

1. Corneal relaxing incision and corneal wedge resection for surgically induced astigmatism are procedures to correct an astigmatism resulting from a previous surgery (e.g., cataract surgery or a corneal transplant).  In corneal relaxing, an "X" cut is made on the corneal surface.  Slices along the "X" are removed and its edges are sutured. In the corneal wedge resection, a wedge is cut from the cornea and the edges sutured.
2. Laser in situ keratomileusis (LASIK) is a variation on the PRK method.  LASIK is a type of laser surgery of the cornea to correct refractive errors. During LASIK, a surgeon uses lasers and a cutting tool called a microkeratome that works similar to a carpenter's plane, to form a circular flap on the cornea, which is flipped back to expose the inner layers of the cornea. An excimer laser is then used to shape the interior portions of the cornea to the desired curvature.  The flap is then sewn back in place and allowed to heal. LASIK procedures have emerged as the most frequently used option.
3. Automated lamellar keratoplasty (ALK) is a procedure similar in technique to LASIK, where a flap is made in the upper surface of the eye and the interior structure is altered to change the curvature of the cornea, but no lasers are used.  Instead of a laser to reshape the inner eye structure, a microkeratome is used. ALK is used for the treatment of moderate farsightedness.
4. Radial keratotomy (RK) is a procedure in which a surgeon uses a delicate diamond-tipped surgical blade, a microscope, and microscopic instruments to make several spoke-like, "radial" incisions in the non-viewing (peripheral) portion of the cornea.  The slits surgically alter the curve of the cornea, making it flatter, which may improve the focus of images onto the retina.  Variants are known as mini RK, hexagonal RK and astigmatic RK.
5. Photorefractive keratectomy (PRK) is a refractive surgical procedure involving the reshaping of the surface with the use of a computer to measure the shape of the cornea. Using these measurements, the surgeon applies a computer-controlled excimer laser to make modifications to the cornea for correction of refractive errors (e.g., myopia, hyperopia, astigmatism, and presbyopia in individuals with otherwise non-diseased corneas). The PRK procedure flattens the cornea by vaporizing small amounts of tissue from the cornea's surface to correct mild to moderate myopia. A similar procedure, photoastigmatic keratectomy (PARK or PRK-A) is a refractive surgical procedure to correct myopia with astigmatism. Photorefractive keratectomy should not be confused with phototherapeutic keratectomy (PTK). Phototherapeutic keratectomy refers to procedures to correct disorders of the cornea. PTK in not addressed in this document.
6. Laser epithelial keratomileusis (LASEK) is a modification of PRK that attempts to preserve the epithelium. A trephine and spatula are used sequentially to score, loosen, and roll up the epithelium, which remains attached at a nasal or superior hinge. Photoablation is then performed, and the epithelium is unrolled back over the central, lasered corneal stroma. A bandage contact lens is used for several days until the epithelium is intact.
7. Epikeratoplasty (or epikeratophakia - lamellar keratoplasty) is a refractive surgical procedure that involves shaving a portion of the cornea and then replacing it with a pre-shaped donor cornea. (Also called non-penetrating or layered).
8. Keratophakia involves implantation of a donor cornea, plastic lens, or a slice of the individual's own cornea (which is removed and reshaped) underneath the person's own cornea to improve the shape of the corneal area.
9. Orthokeratology (Ortho-K) involves the application of sequentially flatter hard contact lenses to flatten the cornea and, thereby, reduce myopic refractive error. Unlike traditional contact lenses, the lenses involved in Ortho-K do not refract like glasses do, but only serve to alter the shape of the cornea to achieve normal vision.
10. Laser thermal keratoplasty describes the use of a holmium: YAG laser that is applied to the periphery of the cornea, causing shrinkage of the collagen fibrils, thus steepening its shape and improving its refractive power.     
11. Clear lens extraction (CLE) is a surgical procedure in which the non-cataractous crystalline lens is removed and replaced with an intraocular lens for refractive purposes.

Keratoconus
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 for those individuals who develop intolerance to contact lenses. While visual acuity is typically improved with a keratoplasty, there is an associated risk of perioperative complications, long-term topical steroid use is required and endothelial cell loss occurs over time, which is a particular concern in younger individuals. 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 where 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 individuals in whom the cornea has remained transparent and who are intolerant of contact lenses.

Aniseikonia: The condition in which an image in one eye differs in size or shape from the same image in the other eye.

Anisometropia: The condition in which both eyes have an unequal refractive power; one eye may be myopic (nearsighted) and the other hyperopic (farsighted).

Aphakia: Absence or loss of the eye's natural crystalline lens, as after cataract removal.

Astigmatism: A common form of visual impairment in which part of an image is blurred, due to an irregularity in the curvature of the front surface of the eye, the cornea.

Hyperopia: (farsightedness) The ability to see distant objects more clearly than close objects.

Keratoconus: Cone-shaped cornea with the apex of the cone being forward; also called conical cornea.

Myopia: (nearsightedness) The ability to see close objects more clearly than distant objects.

Presbyopia: Age related visual change affecting near vision.

Refraction: In ophthalmology, the bending of light that takes place within the human eye; this results in vision ability, such as "20/20."

Refractive error (ametropia): A disorder that occurs when parallel rays of light entering the non-accommodating eye are not focused on the retina; includes nearsightedness (myopia), farsightedness (hyperopia), and astigmatism; lenses can be used to control the amount of refraction, correcting those errors.

Stroma: The supportive framework of an organ (or gland or other structure); the stroma is usually composed of connective tissue.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

LASIK, Epikeratoplasty, PRK, Post-cataract correction

When Services may be Medically Necessary when criteria are met: 

When Services are Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met, and for all other diagnoses not listed.

Implantation of intrastromal corneal ring segments
When Services may be Medically Necessary when criteria are met: 

When Services are Not Medically Necessary:
For the procedure code listed above, when criteria are not met and for all other diagnoses not listed including, but not limited to, myopia

Clear lens extraction
When Services are Not Medically Necessary: 

Other procedures
When Services are Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as not medically necessary. 

Future ICD-10 coding (effective 10/01/2013)
A draft of ICD-10 Coding related to this document, as it might look today, is available for reference and comments at: Appendix 1: Future ICD-10 coding

Peer Reviewed Publications:

1. Alio JL, Shabayek MH, Artola A.  Intracorneal ring segments for keratoconus correction: long-term follow-up. J Cataract Refract Surg. 2006; 32(6):978-985.
2. Boxer Wachler BS, Changra NS, et al. INTACS for keratoconus. Ophthalmol. 2003; 110:1031-1040.
3. Colin J, Cochener B, Savary G, et al. INTACS inserts for treating keratoconus. Ophthalmol. 2001; 108:1409-1414.
4. Colin J, Malet FJ. Intacs for the correction of keratoconus: two-year follow-up.J Cataract Refract Surg. 2007; 33(1):69-74.
5. Kanellopoulos AJ, Pe LH, Perry HD, Donnenfeld ED. Modified intracorneal ring segment implantations (INTACS) for the management of moderate to advanced keratoconus: efficacy and complications. Cornea. 2006; 25(1):29-33.
6. Kymionis GD, Siganos CS, Tsiklis NS, et al. Long-term follow-up of Intacs in keratoconus. Am J Ophthalmol. 2007; 143(2):236-244.
7. Siganos CS, Kymionis GD, Kartakis N et al. Management of keratoconus with Intacs. Am J Ophthalmology 2003; 135(1):64-70.

Government Agency, Medical Society, and Other Authoritative Publications: 

1. American Academy of Ophthalmology (AAO). Preferred Practice Patterns^®: Ophthalmic Technology Assessment: Excimer laser photorefractive keratectomy (PRK) for myopia and astigmatism. Ophthalmology. 1999; 106:422-437. For additional information: http://one.aao.org/CE/PracticeGuidelines/Ophthalmic_Content.aspx?cid=8a4efe64-40f5-48ea-a7cb-0802ad3df4f4. Accessed on April 14, 2011.
2. American Academy of Ophthalmology (AAO). Preferred Practice Patterns^®: Refractive Errors and Refractive Surgery. September, 2007. For additional information: http://one.aao.org/CE/PracticeGuidelines/Snippet.aspx?cid=0e3fa6ce-611c-4508-ace0-b2bce8ce5b43. Accessed on April 14, 2011.
3. American Academy of Ophthalmology (AAO). Preferred Practice Patterns^®: Summary Recommendations for LASIK. Updated January 2008. For additional information: http://one.aao.org/CE/PracticeGuidelines/ClinicalStatements.aspx?sid=8cdb05a3-ad43-47a5-908e-53557c084047. Accessed on April 14, 2011.
4. American Academy of Ophthalmology (AAO). Preferred Practice Patterns^®: Summary Recommendations for Photorefractive Keratectomy (PRK) Surgery. Updated January 2008. For additional information: http://one.aao.org/CE/PracticeGuidelines/ClinicalStatements.aspx?sid=8cdb05a3-ad43-47a5-908e-53557c084047. Accessed on April 14, 2011.
5. Centers for Medicare and Medicaid Services. National Coverage Determination for Laser Procedures. NCD #140.5. Effective May 1, 1997. Available at: http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=140.5&ncd_version=1&basket=ncd%3A140%2E5%3A1%3ALaser+Procedures. Accessed on April 14, 2011.
6. Centers for Medicare and Medicaid Services. National Coverage Determination for Refractive Keratoplasty. NCD #80.7. Effective May 1, 1997. Available at:  http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=80.7&ncd_version=1&basket=ncd%3A80%2E7%3A1%3ARefractive+Keratoplasty. Accessed on April 14, 2011.
7. National Institute for Health and Clinical Excellence (NICE). Corneal implants for keratoconus (interventional procedures overview). March 2007. Available at: http://guidance.nice.org.uk/page.aspx?o=ip391overview. Accessed on April 14, 2011.
8. National Institute for Health and Clinical Excellence (NICE). Photorefractive (laser) surgery for the correction of refractive error: Guidance. March 2006. Available at: http://www.nice.org.uk/page.aspx?o=IPG164guidance.  Accessed on April 14, 2011.
9. Rapuano CJ, Sugar A, Koch DD, et al. Intrastromal corneal ring segments for low myopia: a report by the American Academy of Ophthalmology. Ophthalmology. 2001; 108(10):1922-1928.
10. Sugar A, Rapuano CJ, Culbertson WW, Huang D, et al. Laser in situ keratomileusis for myopia and astigmatism: safety and efficacy: a report by the American Academy of Ophthalmology. Ophthalmology. 2002; 109(1):175-187.
11. U.S. Food and Drug Administration (FDA). Listing of lasers approved for use with LASIK. Updated April 7, 2011. Available at: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?search_term=LZS%20or%20LASIK.  Accessed on April 14, 2011.
12. U.S. Food and Drug Administration (FDA). New Humanitarian Device Approval. INTACS^™ Prescription Inserts for Keratoconus No. H040002. Updated July 26, 2004. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=H040002. Accessed on April 13, 2011.
13. Varley GA, Huang D, Rapuano CJ, et al.Ophthalmic Technology Assessment Committee Refractive Surgery Panel, American Academy of Ophthalmology. LASIK for hyperopia, hyperopic astigmatism, and mixed astigmatism: a report by the American Academy of Ophthalmology. Ophthalmology. 2004; 111(8):1604-1617.

1. Medline Plus. Refractive Errors. Last reviewed November 30, 2010. Available at: http://www.nlm.nih.gov/medlineplus/refractiveerrors.html. Accessed on April 13, 2011.

Artisan^™ Phakic Lens
Epikeratophakia
Epikeratoplasty
INTACS^™
LASIK
PRK
Visian ICL^™

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.