Clinical UM Guideline |
Subject: Refractive Surgery | |
Guideline #: CG-SURG-77 | Publish Date: 01/03/2024 |
Status: Reviewed | Last Review Date: 11/09/2023 |
Description |
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:
Clinical Indications |
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:
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:
Small incision lenticule extraction (SMILE) is considered medically necessary when all of the following criteria are met:
Epikeratoplasty (epikeratophakia) is considered medically necessary for either of the following conditions:
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:
Not Medically Necessary:
Procedures considered not medically necessary include, but are not limited to, the following:
Coding |
The following codes for treatments and procedures applicable to this guideline 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, SMILE, 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, SMILE, 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 or 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 and diagnosis codes listed above when criteria are not met or for all other diagnoses not listed.
Clear lens extraction
When services are Not Medically Necessary:
CPT |
|
| For the following codes when specified as clear lens extraction for refractive surgery: |
66840 | Removal of lens material; aspiration technique, one or more stages |
66850 | Removal of lens material; phacofragmentation technique (mechanical or ultrasonic) (eg, 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 |
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:
For the following procedure codes; or when the code describes a procedure designated in the Clinical Indications 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] |
|
|
HCPCS |
|
S0596 | Phakic intraocular lens for correction of refractive error |
|
|
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 |
Discussion/General Information |
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.
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 (INTACS™ Prescription Inserts) 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 studied in individuals in whom the cornea has remained transparent and who are intolerant to contact lenses.
Refractive Surgery
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:
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 the indications listed in this document as not medically necessary.
The most recent American Academy of Ophthalmology (AAO) Preferred Practice Pattern on Refractive Surgery (2022) states, “Refractive surgery may be considered when a patient wishes to be less dependent on eyeglasses or contact lenses, or when there are occupational or cosmetic reasons not to wear eyeglasses.” The AAO Preferred Practice Pattern does not discuss vision outcomes after refractive surgery compared with eyeglasses or contact lenses.
The research on the relative effectiveness of different types of refractive surgery compared with no surgery was summarized in a network meta-analysis published in 2017 by Wen and colleagues. Trials were included if they treated individuals with PRK, T-PRK, LASEK, Epi-LASIK, LASIK, femtosecond (FS)-based LASIK, femtosecond lenticule extraction (FLEx), or SMILE. The authors identified 48 randomized controlled trials (RCTs) comparing two or more types of refractive surgery in individuals with myopia. A total of 4234 study participants (5256 eyes) were included in the analysis. For specific procedures, this involved 1036 individuals (1174 eyes) undergoing LASIK, 500 individuals (594 eyes) undergoing FS-LASIK, 1392 individuals (1737 eyes) undergoing PRK, 900 individuals (1326 eyes) undergoing LASEK, 131 individuals (150 eyes) undergoing Epi-LASIK, 105 individuals (105 eyes) undergoing T-PRK, 110 individuals (110 eyes) undergoing SMILE, and 60 individuals (60 eyes) undergoing FLEx. Their network meta-analysis indirectly comparing techniques to one another did not find any statistically significant differences among procedures in efficacy (uncorrected distance visual acuity [UDVA] of 20/20 or better) or safety (losing 2 or more lines of best spectacle-corrected visual acuity [BSCVA] at 6 months post-surgery). For predictability (refractive spherical equivalent within ± 0.50D of the target), FS-LASIK was significantly better than any other type of surgery. The Wen analysis did not address the relative efficacy of refractive surgery and eyeglasses or contact lenses.
Meta-analyses have been published of literature comparing clinical outcomes after SMILE and FS-LASIK. Yan (2017) included comparative studies conducted with adults who had myopia or myopic astigmatism. The primary efficacy outcome was the proportion of eyes achieving an uncorrected distance visual acuity (UDVA) of 20/20 or better. A total of 2 RCTs and 25 non-randomized comparative studies met the inclusion criteria. In a pooled analysis of the 7 studies reporting this outcome, no significant difference was found in the proportion of eyes with an uncorrected visual acuity (UCVA) of 20/20 or better (odds ratio [OR]: 0.77; 95% confidence interval [CI], 0.54 to 1.09; p=0.04). Among other outcomes, there were no significant differences between groups in the percentage of eyes losing at least 1 line of BSCVA (7 studies), in the proportion of individuals with postoperative refraction within 1.0D of the target refraction (6 studies), or in the mean refractive spherical equivalent outcomes (11 studies).
A meta-analysis by Fu and colleagues (2021) included comparative studies in adults with high myopia (preoperative spherical equivalent refractive error of -6.00 D or worse, or spherical refractive error worse than -5.00 D and cylindrical refractive error worse than -1.00). The authors identified 12 studies, 1 of which was an RCT. In a pooled analysis of 6 studies, there was no significant difference in UDVA between the SMILE and FS-LASIK groups. At the 3 month follow-up, the weighted mean difference (WMD)=-0.00, 95% CI, -0.01 to 0.00, p=0.33). Another pooled analysis of 6 studies did not find a significant difference between groups for postoperative mean refractive SE (WMD, -0.03, 95% CI, -0.09 to 0.03, p=0.30). A meta-analysis of 5 studies found significantly better postoperative corrected distance visual acuity (CDVA) in the SMILE group compared with the FS-LASIK group (WMD, -0.04, 95% CI, -0.05 to -0.02, p<0.00001).
A 2023 RCT by Ma and Manche compared FS-LASIK and SMILE surgeries. A total of 80 individuals were randomized to receive one of these procedures in their dominant eye and the other procedure in the contralateral eye. Eligibility criteria included -0.75 to -8.00 D of spherical myopia and less than 3.00 D of astigmatism. All procedures were done by a single surgeon. At months 1,3, 6 and 12 after surgery, there were no significant differences in scores on the validated Patient-Reported Outcomes With Laser In Kitu Karatomileusis (PROWL) questionnaire (p>0.85 for each comparison). At month 12, 97% of participants reported that they were ‘overall happy’ with the results of the surgery.
Several systematic reviews have addressed biomechanical changes after flap-based refractive surgery (e.g. LASIK, FS-LASIK and FLEx) and the non-flap-based SMILE procedure in individuals with myopia. Guo 2019 reviewed 22 studies; 6 RCTs 15 cohort studies and 2 cross-sectonal studies. A total of 17 studies addressed the SMILE procedure and there were 14 on LASIK, 4 on FLEX, 2 on LASEK, and 1 on PRK. In an analysis of corneal hysteresis [CH] and corneal resistence factor [CRF]), the pooled Hedges’ g was significantly better with the SMIILE procedure compared with FS-LASIK and LASIK and was not significantly different that LASEK or PRK. Raevdal, 2018 included 9 studies, 3 RCTs and 6 non-randomized observational studies. Pre-treatment to post-treatment comparisons found statistically significant reductions in corneal viscoclassic properties in all studies, regardless of the type of procedure. The RCTs did not find significant differences between SMILE and flap-based procedures in biomechanical outcomes (CH and CRF). However, among observational studies, 2 found significant differences in change in CH, favoring the SMILE procedure, and 5 studies found significant differences in CRF, in favor of SMILE. These systematic reviews did not address differences in vision outcomes.
A systematic review of RCTs comparing LASIK and the SMILE and reporting vision outcomes was published by Yao and colleagues in 2022. A total of 11 RCTs met the eligibility criteria, which included follow-up of more than 3 months and being conducted in adults with myopia or myopic astigmatism. In a meta-analysis of 8 RCTs, there was no significant differences between the LASIK and SMILE groups in the proportion of eyes losing one or more eyes of CDVA (RR, 1.14, 95% CI, 0.58 to 2.27, p=0.70) or in the proportion of eyes achieving UCVA of 20/20 or better at follow-up (RR, 9.99, 95% CI, 0.94 to 1.05, p=0.71). The study also investigated the predictability measures, postoperative refraction within 0.5 and 1.0D and postoperative astigmatism within 0.25, 0.5 and 1.0D. the proportion of eyes with refraction within 0.5D was significantly higher in the LASIK group than the SMILE group (RR, 0.91, 95% CI, 0.83 to 0.99, p=0.04) and there was no significant difference between groups for refraction within 1.0D. There was no significant difference between groups for the postoperative astigmatism outcomes.
For individuals with keratoconus, there are several case series on intrastromal corneal implants. 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 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 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).
A systematic review by Afsharpaiman and colleagues (2020) evaluated the published literature and found a low rate of infectious keratitis complications after refractive surgery. The authors identified 14 studies, which included over 2 million eyes. In a pooled analysis, the incidence of infectious keratitis after refractive surgery was 0.00015%. By procedure, incidence was 0.0006 after LASIK, 0.0005 after LASEK and 0.00012 after PRK.
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.
Spectacle prescription abbreviations:
Stroma: The supportive framework of an organ (or gland or other structure); the stroma is usually composed of connective tissue.
References |
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Websites for Additional Information |
Index |
Artisan Phakic Lens
Epikeratophakia
Epikeratoplasty
INTACS
LASEK
LASIK
PRK
SMILE
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.
History |
Status | Date | Action |
Reviewed | 11/09/2023 | Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Discussion/General Information and References sections. |
Reviewed | 11/10/2022 | MPTAC review. Discussion/General Information and References sections updated. |
Reviewed | 11/11/2021 | MPTAC review. Discussion/General Information and References sections updated. |
Reviewed | 11/05/2020 | MPTAC review. Discussion/General Information and References sections updated. Reformatted Coding section. |
Reviewed | 11/07/2019 | MPTAC review. Discussion/General Information and References sections updated. |
Revised | 01/24/2019 | MPTAC review. Medically necessary indications added for small incision lenticule extraction (SMILE). SMILE added to not medically necessary indications when medically necessary criteria are not met. Discussion/General Information and References sections updated. |
New | 05/03/2018 | MPTAC review. Initial document development. Moved content of SURG.00009 Refractive Surgery to new clinical utilization management guideline document with the same title. Updated Discussion, References and Index sections. |
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