Medical Policy



Subject: Refractive Surgery
Document #: SURG.00009 Current Effective Date:    06/28/2017
Status: Reviewed Last Review Date:    05/04/2017

Description/Scope

This document addresses refractive surgeries which refers to various surgical procedures performed to correct refractive errors of the eye.

Note: This document does not address PTK (phototherapeutic keratotomy) which refers to procedures to correct disorders of the cornea.

For information concerning related topics, see:

Position Statement

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: (1) contact lenses, (2) spectacles, or (3) 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: (1) contact lenses, (2) spectacles, or (3) 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 (INTACS Prescription Inserts, 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 Verisyse 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 (INTACS) for the correction of myopia;
  11. Conductive keratoplasty to treat presbyopia (that is, ViewPoint CK System [Refracrtec Inc., Irvine, CA]);
  12. Keratophakia;
  13. Orthokeratology;
  14. Standard keratomileusis.
Rationale

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.  Surgical devices used to perform conductive keratoplasty have received U.S. Food and Drug Administration (FDA) clearance as a treatment of presbyopia.  Implantation of phakic intraocular lenses (IOLs) is another option.  The Artisan Phakic Intraocular Lens (PIOL) also known as Verisyse Phakic IOL (VRSM5US and VRSM6US; Ophtec BV, Groningen, Netherlands) and the Visian ICL (implantable collamer lens) (Staar Surgical Co., Aliso Viejo, CA) have received FDA clearance 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 (that is, radial keratotomy and its variants, photorefractive keratectomy), these procedures have been largely superseded by LASIK (laser in-situ keratomileusis), which has emerged as the most commonly performed refractive procedure.  Multiple laser systems have been cleared by the FDA for use in LASIK treatment for the reduction or elimination of hyperopia refractive errors, subject to similar model-specific parameters for refractive error ranges.

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.  In 2007, the American Academy of Ophthalmology (AAO) issued information about refractive errors/surgery which states:

Refractive lens exchange for myopia and hyperopia has been demonstrated to be predictable and effective, but no large-scale investigations on complications have been reported. Complications that may result in a permanent loss of vision are rare and include infectious endophthalmitis, intraoperative suprachoroidal hemorrhage, cystoid macular edema (CME), retinal detachment, corneal edema, and IOL dislocation (AAO, 2007).

The most recent AAO Preferred Practice Pattern on Refractive Surgery states, "Eyeglasses are the simplest and safest means of correcting a refractive error, therefore, eyeglasses should be considered before contact lenses or refractive surgery"(AAO, 2013).  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 the indications listed in this document as not medically necessary.

In 2004, INTACS Prescription Inserts for Keratoconus (Addition Technology, Inc., Sunnyvale CA) received FDA clearance 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:

The published data regarding intrastromal corneal implants for keratoconus consist of single institution case series.  Boxer Wachler (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 (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 (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 (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≤0.001).  Colin and Malet (2007) reported outcomes of a 2-year follow-up study comprised of 100 eyes after INTACS implantation.  At 2 years, the uncorrected visual acuity (UCVA) and BCVA improved in 80.5% and 68.3% of eyes, respectively (p<0.001).  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<0.001).  Contact lens tolerance was restored in over 80% of cases.  Additional recent case series and retrospective reviews continue to show promising results for intrastromal corneal implants for the treatment of refractory keratoconus (Bedi, 2012; Ozerturk, 2012; Torquetti, 2014).

Background/Overview

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 (for example, 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 (for example, 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 (that is, 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, which are 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 to contact lenses.

Definitions

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; this is also called conical cornea.

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

Presbyopia: Age related visual changes affecting near vision.

Refraction: In ophthalmology, this term refers to 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; this includes nearsightedness (myopia), farsightedness (hyperopia), and astigmatism; lenses can be used to control the amount of refraction, correcting these errors.

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

Coding

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: 

CPT  
65767 Epikeratoplasty
65772 Corneal relaxing incision for correction of surgically induced astigmatism
65775 Corneal wedge resection for correction of surgically induced astigmatism
66999 Unlisted procedure, anterior segment of eye [when specified as laser epithelial keratomileusis (LASEK) or photoastigmatic keratectomy (PRK-A)]
   
HCPCS  
S0800 Laser in situ keratomileusis (LASIK)
S0810 Photorefractive keratectomy (PRK)
   
ICD-10 Procedure  
  For the following procedures when specified as LASIK, LASEK, PRK:
08Q8XZZ-08Q9XZZ Repair cornea, external approach [right or left; includes codes 08Q8XZZ, 08Q9XZZ]
  For the following procedures, when specified as correction of surgically induced astigmatism:
08T8XZZ-08T9XZZ Resection of cornea, external approach [right or left; includes codes 08T8XZZ, 08T9XZZ]
  For the following procedures when specified as epikeratoplasty, epikeratophakia;
08U80KZ-08U9XKZ Supplement cornea with nonautologous tissue substitute [left or right, by approach; includes codes 08U80KZ, 08U83KZ, 08U8XKZ, 08U90KZ, 08U93KZ, 08U9XKZ]
   
ICD-10 Diagnosis  
H27.00-H27.03 Aphakia
H52.00-H52.03 Hypermetropia
H52.10-H52.13 Myopia
H52.201-H52.229 Astigmatism
H52.31 Anisometropia
H52.32 Aniseikonia
Q12.3 Congenital aphakia
T85.318A-T85.318S Breakdown (mechanical) of other ocular prosthetic devices, implants and grafts
T85.328A-T85.328S Displacement of other ocular prosthetic devices, implants and grafts
T85.398A-T85.398S Other mechanical complication of other ocular prosthetic devices, implants and grafts
Z96.1 Presence of intraocular lens

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: 

CPT  
65785 Implantation of intrastromal corneal ring segments
   
ICD-10 Diagnosis  
H18.601-H18.629 Keratoconus
Q13.4 Other congenital corneal malformations [specified as congenital keratoconus]

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: 

  CPT  
  For the following codes when specified as clear lens extraction for refractive errors:
66840 Removal of lens material; aspiration technique, one or more stages
66850 Removal of lens material; phacofragmentation technique (mechanical or ultrasonic) (e.g., phacoemulsification), with aspiration
66852 Removal of lens material; pars plana approach, with or without vitrectomy
66920 Removal of lens material; intracapsular
66930 Removal of lens material, intracapsular, for dislocated lens
66940 Removal of lens material; extracapsular (other than 66840, 66850, 66852)
66985 Insertion of intraocular lens prosthesis (secondary implant), not associated with concurrent cataract removal
   
HCPCS  
C1780 Lens, intraocular (new technology) [ASC billing]
Q1004 New technology intraocular lens category 4
Q1005 New technology intraocular lens category 5
S0596 Phakic intraocular lens for correction of refractive error
V2630 Anterior chamber intraocular lens
V2631 Iris supported intraocular lens
V2632 Posterior chamber intraocular lens
V2787 Astigmatism correcting function of intraocular lens
V2788 Presbyopia correcting function of intraocular lens
   
ICD-10 Diagnosis  
H52.00-H52.03 Hypermetropia
H52.10-H52.13 Myopia
H52.201-H52.229 Astigmatism
H52.31 Anisometropia
H52.32 Aniseikonia
H52.4 Presbyopia
H52.6 Other disorders of refraction
H52.7 Unspecified disorder of refraction

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

CPT  
65760 Keratomileusis
65765 Keratophakia
65771 Radial keratotomy
66999 Unlisted procedure, anterior segment of eye [when specified as laser thermal keratoplasty, conductive keratoplasty, orthokeratology]
   
ICD-10 Procedure  
  For the following procedures when specified as keratomileusis, radial keratotomy, thermokeratoplasty, conductive keratoplasty, orthokeratology:
08Q8XZZ-08Q9XZZ Repair cornea, external approach [right or left; includes codes 08Q8XZZ, 08Q9XZZ]
  For the following procedures when specified as keratophakia:
08U80KZ-08U9XKZ Supplement cornea with nonautologous tissue substitute [left or right, by approach; includes codes 08U80KZ, 08U83KZ, 08U8XKZ, 08U90KZ, 08U93KZ, 08U9XKZ]
   
ICD-10 Diagnosis  
  All diagnoses
   
References

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. Bedi R, Touboul D, Pinsard L, Colin J. Refractive and topographic stability of Intacs in eyes with progressive keratoconus: five-year follow-up. J Refract Surg. 2012; 28(6):392-396.
  3. Boxer Wachler BS, Christie JP, Chandra NS, et al. INTACS for keratoconus. Ophthalmology. 2003; 110(5):1031-1040.
  4. Colin J, Cochener B, Savary G, et al. INTACS inserts for treating keratoconus. Ophthalmology. 2001; 108(8):1409-1414.
  5. Colin J, Malet FJ. Intacs for the correction of keratoconus: two-year follow-up. J Cataract Refract Surg. 2007; 33(1):69-74.
  6. 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.
  7. Koch DD, Maloney R, Hardten DR, et al. Wavefront-guided photorefractive keratectomy in eyes with prior radial keratotomy: a multicenter study. Ophthalmology. 2009; 116(9):1688-1696.e2.
  8. Kymionis GD, Siganos CS, Tsiklis NS, et al. Long-term follow-up of Intacs in keratoconus. Am J Ophthalmol. 2007; 143(2):236-244.
  9. Ozerturk Y, Sari ES, Kubaloglu A, et al. Comparison of deep anterior lamellar keratoplasty and intrastromal corneal ring segment implantation in advanced keratoconus. J Cataract Refract Surg. 2012; 38(2):324-332.
  10. Siganos CS, Kymionis GD, Kartakis N et al. Management of keratoconus with Intacs. Am J Ophthalmol. 2003; 135(1):64-70.
  11. Torquetti L, Berbel RF, Ferrara P. Long-term follow-up of intrastromal corneal ring segments in keratoconus. J Cataract Refract Surg. 2009; 35(10):1768-1773.
  12. Torquetti L, Ferrara G, Almeida F, et al. Intrastromal corneal ring segments implantation in patients with keratoconus: 10-year follow-up. J Refract Surg. 2014; 30(1):22-26.
  13. Wong RC, Yu M, Chan TC, et al. Longitudinal comparison of outcomes after sub-Bowman keratomileusis and laser in situ keratomileusis: randomized, double-masked study. Am J Ophthalmol. 2015; 159(5):835-845.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Academy of Ophthalmology (AAO). Preferred Practice Patterns® : Refractive Errors and Refractive Surgery. September, 2007; reprinted 2009; updated July 2013. For additional information visit the AAO website: http://one.aao.org/CE/PracticeGuidelines. Accessed on March 23, 2017.
  2. American Academy of Ophthalmology (AAO). Preferred Practice Patterns® : Summary Recommendations for Keratorefractive Laser Surgery. Updated 2013. For additional information visit the AAO website: http://one.aao.org/CE/PracticeGuidelines. Accessed on March 23, 2017.
  3. American Academy of Ophthalmology (AAO). Preferred Practice Patterns.® Surface Ablation: Photorefractive Keratectomy, LASEK, Epi-LASIK, and Epi-LASEK. Updated 2013. For additional information visit the AAO website: http://one.aao.org/CE/PracticeGuidelines. Accessed on March 23, 2017.
  4. American Academy of Ophthalmology (AAO). Preferred Practice Patterns® : Cataract in the Adult Eye.  Updated October 2011. For additional information visit the AAO website: http://one.aao.org/CE/PracticeGuidelines. Accessed on March 28, 2017.
  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.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=69&ncdver=1&DocID=140.5&ncd_id=140.5&ncd_version=1&basket=ncd%25253A140%25252E5%25253A1%25253ALaser+Procedures&bc=gAAAAAgAAAAAAA%3d%3d&. Accessed on March 23, 2017.
  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.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=72&ncdver=1&DocID=80.7&SearchType=Advanced&bc=IAAAABAAAAAA&. Accessed on March 23, 2017.
  7. Huang D, Schallhorn SC, Sugar A, et al. Phakic intraocular lens implantation for the correction of myopia: a report of the American Academy of Ophthalmology (AAO). Ophthalmology. 2009; 116(11):2244-2258. 
  8. 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.
  9. Shortt AJ, Allan BD. Photorefractive keratectomy (PRK) versus laser-assisted in-situ keratomileusis (LASIK) for myopia. Cochrane Database Syst Rev. 2006;(2):CD005135.
  10. Sugar A, Rapuano CJ, Culbertson WW, et al. Laser in situ keratomileusis for myopia and astigmatism: safety and efficacy: a report by the American Academy of Ophthalmology (AAO). Ophthalmology. 2002; 109(1):175-187.
  11. U.S. Food and Drug Administration (FDA). Listing of lasers approved for use with LASIK. Updated February 6, 2017. Available at:  http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm192109.htm. Accessed on March 23, 2017.
  12. U.S. Food and Drug Administration (FDA). Listing of FDA-approved lasers for PRK and other refractive surgeries. Updated March 25, 2015. Available at:  http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm192110.htm. Accessed on March 23, 2017.
  13. 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 March 23, 2017.
  14. Van Meter WS, Musch DC, Jacobs DS, et al. Safety of overnight orthokeratology for myopia: a report by the American Academy of Ophthalmology. Ophthalmology. 2008; 115(12):2301-2313.
  15. 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.
Websites for Additional Information
  1. American Optometric Association (AOA). Center for Healthy Vision. Astigmatism. © 2016. Available at: http://www.aoa.org/patients-and-public/eye-and-vision-problems/glossary-of-eye-and-vision-conditions/astigmatism?sso=y. Accessed on March 23, 2017.
  2. Medline Plus. Refractive Errors. Last reviewed September 22, 2014. Available at: http://www.nlm.nih.gov/medlineplus/refractiveerrors.html. Accessed on March 23, 2017.
  3. U.S. Food and Drug Administration (FDA). What are phakic lenses? Medical Devices. Rockville, MD: FDA;  Updated October 20, 2015. Available at:  http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/PhakicIntraocularLenses/ucm059237.htm. Accessed on March 23, 2017.
Index

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.

Document History
Status Date Action
Reviewed 05/04/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Updated the formatting in the Position Statement section. References and Websites sections were updated.
Reviewed 05/05/2016 MPTAC review. References were updated.
  01/01/2016 Updated Coding section with 01/01/2016 CPT changes, removed 0099T deleted 12/31/2015; also removed ICD-9 codes.
Reviewed 05/07/2015 MPTAC review. References were updated.
Reviewed 05/15/2014 MPTAC review. References were updated.
Reviewed 05/09/2013 MPTAC review. The Rationale and References were updated.
Reviewed 05/10/2012 MPTAC review. Updated References and Websites.
  04/01/2012 Updated Coding section with 04/01/2012 HCPCS changes.
  11/21/2011 Updated Coding section to remove Note regarding cataract removal.
Reviewed 05/19/2011 MPTAC review. Updated References and Websites.
  04/01/2011 Updated Coding section with 04/01/2011 HCPCS changes; removed Q1003 deleted 03/31/2011.
Reviewed 05/13/2010 MPTAC review. References were updated.
Revised 02/25/2010 MPTAC review. Document was revised to remove keratoprosthesis from the investigational and not medically necessary procedures. This technology is now addressed in a new document: SURG.00115.  The Rationale, Background, Coding and References were also updated.
Revised 05/21/2009 MPTAC review. The medically necessary criteria related to correction of surgically induced astigmatism with a corneal relaxing incision or corneal wedge resection has been expanded to add astigmatism caused by scleral buckling for retinal detachment as a medically necessary indication when the other criteria are also met. The medically necessary criterion for LASIK, LASEK, PRK, PARK (or PRK-A) related to the post-operative spherical equivalent refractive error has been clarified to add if the degree of astigmatism is 3 diopters or greater. The medically necessary criterion for implantation of intrastromal corneal ring segments related to progressive deterioration in functional vision has been clarified to indicate when adequate functional vision cannot be achieved with either contact lenses or spectacles. The list of procedures considered not medically necessary has been clarified regarding radial keratotomy and its variants to remove reference to types of keratotomy (astigmatic, hexagonal, mini-keratotomy). References were also updated.
Reviewed 05/15/2008 MPTAC review. References and Coding were updated.
  02/21/2008 The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.
Revised 05/17/2007 MPTAC review. Medically necessary indications for corneal relaxing incision and corneal wedge resection added.
Revised 06/08/2006 MPTAC review.  Document title, Corneal Refractive Surgery changed. Medically necessary indications for LASEK and PRK/PRK-A added. CLE added as not medically necessary. Added reference to SURG.00061. References and Coding updated.
  11/21/2005 Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).
Revised 09/22/2005 MPTAC review.  Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization. New technology review on Artisan® Phakic Lens and Intacs.
Pre-Merger Organization Last Review Date Document Number Title

Anthem, Inc.

 

07/28/2004

SURG.00009 Corneal Refractive Surgery and Computerized Corneal Topography
WellPoint Health Networks, Inc.

06/24/2004

3.03.20 Eye Surgery for Refractive Errors