Medical Policies - Surgery


Refractive and Therapeutic Keratoplasty

Number:SUR713.001

Effective Date:07-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

*NOTE 1* Services for or related to refraction and the surgical treatment of refraction errors may be noted in the benefit language. Please refer to the appropriate benefit plan to determine benefit eligibility.

Refractive Procedures

Procedures on the eye that are primarily refractive (changing the direction of light rays to correct vision) in nature or that are primarily to compensate for the native refractive error (farsightedness/nearsightedness) of the eye are considered NOT medically necessary, including but not limited to:

Astigmatic keratotomy (AK), whether performed independently or as a part of another service;

Automated lamellar keratoplasty (ALK) or standard keratomileusis;

Conductive keratoplasty (CK) (thermal keratoplasty);

Epikeratoplasty (Epikeratophakia), when used primarily to compensate for native refractive errors;

Hexagonal keratotomy (HK);

Keratophakia;

Laser-In-Situ keratomileusis (LASIK);

Minimally invasive radial keratotomy (MINI-RK);

Orthokeratology (Ortho-K);

Photoastigmatic keratectomy (PARK or PAK-A);

Photorefractive keratectomy (PRK);

Photorefractive keratotomy (PRK) as a treatment of children with anisometropic amblyopia;

Radial keratotomy (RK);

Refractive lamellar keratoplasty (non- penetrating keratoplasty) when performed solely to correct astigmatism;

Refractive lensectomy or removal of the native lens when primarily to alter the refractive state of the eye;

Scleral expansion surgery.

Therapeutic Procedures

Lamellar or non-penetrating keratoplasty may be considered medically necessary for patients with corneal scarring, edema, thinning, distortion, dystrophy, degenerations and keratoconus.

Epikeratoplasty (or epikeratophakia or lamellar keratoplasty or non-penetrating keratoplasty) may be considered medically necessary in the treatment of childhood aphakia.

Penetrating keratoplasty (PK) for significant visual impairment may be considered medically necessary for any of the following indications:

Bullous keratoplasty; or

Chemical burns to the eye; or

Fuch’s dystrophy; or

Keratoconus; or

Severe corneal ulcers caused by bacterial, fungal, parasitic or viral eye infections; or

Severe traumatic injuries that pierce or cut the cornea; or

Severe corneal edema or scarring; or

Descemetocele (corneal thinning).

NOTE 2: Please refer to OTH903.029 for Endothelial Keratoplasty, OTH903.030 for Keratoprosthesis and SUR703.025 for Intraocular Lens (IOL)

Description:

Refractive keratoplasty is a generic term which includes surgical procedures performed to reshape the cornea of the eye to correct vision problems. Vision occurs when light rays are bent or refracted by the cornea and lens and received by the retina, (the nerve layer at the back of the eye), in the form of an image, which is sent through the optic nerve to the brain. Refractive errors occur when the eye cannot properly focus light and images appear out of focus. The main types of refractive errors are myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (distortion). Presbyopia (aging eye) is a problem of the lens and is characterized by the inability to bring close objects into focus. Refractive errors are generally corrected with glasses or contact lenses. Refractive eye surgery (or refractive keratoplasty) involves procedures that permanently change the shape of the corneal surface.

Refractive keratoplasty refers to a variety of surgical procedures that are performed on the cornea to correct refractive errors. Refractive keratoplasty was introduced in the United States approximately 25 years ago, but it was not until FDA approval of phototherapeutic keratectomy using the excimer laser that patient and physician interest accelerated. Refractive keratoplasty can be divided into lamellar procedures and nonlamellar procedures. Nonlamellar procedures alter corneal curvature without the addition or removal of tissue. Lamellar procedures involve the removal of tissue from the cornea or the addition of tissue or synthetic material to change its refractive power. Refractive keratoplasty continues to be a rapidly evolving field, and techniques are likely to advance in the future. (1)

Refractive and Therapeutic keratoplasties include, but are not limited to the following surgical procedures:

Astigmatic keratotomy (AK) is a refractive surgical procedure that is used to reduce astigmatism (irregular shaped cornea). One or two incisions are made at the steepest part of the cornea. These incisions cause the cornea to relax and take a more rounded shape, thereby reducing low to moderate astigmatism. (2,3) AK is often used in conjunction with other vision correction procedures and has been largely replaced by Laser-In-Situ keratomileusis (LASIK). Variations of AK include the Ruiz procedure and the Troutman wedge resection, also known as corneal wedge resection.

Automated lamellar keratoplasty (ALK) or standard keratomileusis was an antecedent of LASIK. This surgical procedure was used to create a corneal flap mechanically and then mechanically remove a lenticule of stromal tissue. Complications may include irregular stigmatism, thin flaps, free of displaced caps, corneal perforation, interface opacities, microbial keratitis and epithelial ingrowth. With the advent of LASIK, ALK using mechanical microkeratomes has been largely abandoned. (3)

Conductive keratoplasty (CK) or thermokeratoplasty involves the application of low level radiofrequency thermal energy to form a circular pattern on the outer part of the cornea which alters the curvature of the cornea and reduces mild to moderate hyperopia (farsightedness). This change in the curvature of the eye's surface affects the way light rays enter the eye to bring near vision back into focus. (4,6)

Epikeratoplasty (epikeratophakia) is a surgical procedure aimed at correcting ametropia, a faulty refractive ability of the eye. The patient's corneal epithelium is removed and a donor's corneal disc (or lenticule) that was previously frozen and reshaped to produce a new anterior curvature is rehydrated and sutured to the Bowman's membrane. The lenticule can be removed and exchanged to provide a different power. (1) There are potential complications related to this procedure to include poor incision healing, irregular astigmatism, interface haze, lenticule necrosis and microbial keratitis. (3)

Hexagonal Keratotomy (HK) is a refractive surgical technique in which six linear incisions are made into the stroma of the peripheral cornea in a hexagonal pattern that encircles the central cornea in an attempt to correct hyperopia (farsightedness). This procedure is now rarely used, as newer techniques in refractive surgery have been developed. (5)

Keratophakia is a surgical procedure in which the anterior section of the patient's cornea is removed and replaced with a donor corneal stroma with the intent to modify a refractive error. The anterior corneal surface is steepened. (1)

Laser-In-Situ keratomileusis (LASIK) is a non-reversible refractive procedure to correct myopia, hyperopia, or astigmatism. The physician uses an excimer laser to cut or reshape the cornea and then it is reattached back to the cornea so that the light will focus properly on the retina. (6)

Minimally invasive radial keratotomy (mini-RK) is intended in cases of low to moderate myopia, to alter the cornea’s shape and consequently the refraction by reducing the millimeters of cornea that are incised. (7)

Orthokeratology is a procedure in which a patient is fitted with special gas permeable contact lenses to reshape the cornea and correct mild to moderate myopia. (8)

Penetrating Keratoplasty (PK) or traditional full thickness cornea transplant involves removal of a full thickness circular button-shaped section of tissue from the diseased or injured cornea using either a surgical cutting instrument called a trephine or femtosecond laser. A matching "button" from the donor tissue is then positioned and sutured into place. (9)

Photoastigmatic keratectomy (PARK or PAK-A) is a refractive surgical procedure utilizing an excimer laser to correct myopia with mild to moderate degrees of astigmatism and is a variation of PRK. (3)

Photorefractive keratectomy (PRK) is also known as surface ablation. PRK is a refractive surgery in which the surgeon uses an excimer laser to reshape the cornea of the eye by removing the epithelium, the gel-like outer layer of the cornea, and the outermost layer below the epithelium is treated with laser. PRK eliminates or reduces moderate myopia (nearsightedness), hyperopia (farsightedness), and astigmatism (3, 8). PRK is still not as accurate or as predictable as correcting myopia with contact lenses or spectacles, which has a virtually 100% chance of achieving 20/20 or better vision in a healthy eye. (10)

Radial keratotomy (RK) is a surgical procedure that utilizes 4-8 radial paracentral corneal incisions, in a pattern much like the spokes of a wheel that are positioned outside a central optical zone to flatten the central corneal curvature. This is one of the oldest refractive procedures, and is not utilized since the advent of PRK and LASIK. (3)

Refractive lamellar keratoplasty (non- penetrating keratoplasty) is a corneal transplant procedure in which a partial thickness of the cornea is removed. The diseased tissue is replaced with a partial thickness donor cornea. (11)

Refractive lensectomy (Refractive lens exchange, lens replacement surgery or clear lens extraction) is a refractive surgical procedure for people with presbyopia and high hyperopia (farsightedness). Refractive lens exchange replaces your eye's clear natural lens with an accommodative intraocular lens to correct a refractive error and achieve sharper focus, reducing the need for reading glasses or bifocals. (12)

Scleral expansion surgery (Scleral Expansion Bands [SEB]) involves insertion of small polymethylmethacrylate (PMMA) bands in the sclera over the ciliary body to allow for accommodation (focusing on close objects). (13)

Rationale:

Myopia, hyperopia and astigmatism are extremely common refractive errors of the eye and may be considered anatomic variants. Refractive errors are effectively corrected with either spectacles or contact lenses. Refractive surgery offers a permanent form of correction.

Although some procedures are U.S. Food and Drug Administration (FDA) approved, the overall critical issue regarding refractive surgical procedures is the medical outcome. Although the efficacy of refractive surgery is improving, the accuracy and precision of the refractive corrections achieved is substantially less than that which can be achieved with spectacle correction. Spectacles or contact lenses have been shown to provide more accurate corrections of refractive errors than refractive surgery.

For the U.S. FDA approved indications and indications accepted by the American Academy of Ophthalmology (AAO), refractive surgical procedures are considered not medically necessary, because spectacles or contact lenses have been shown to provide more accurate corrections of refractive errors than refractive surgery.

In 2013 the AAO Preferred Practice Pattern on Refractive Surgery stated” Eyeglasses are the simplest and safest means of correcting a refractive error, therefore, eyeglasses should be considered before contact lens or refractive surgery”. The published evidence has failed to demonstrate superiority of refractive surgical procedures, in terms of safety and long term benefit over standard eyewear including glasses and contact lenses. (3)

Astigmatic keratotomy (AK) (arcuate incision, corneal wedge resection)

With AK, limbal relaxing incisions (LRI) are placed on the far peripheral portion of the cornea and may be used to treat low to moderate degrees of astigmatism and have been performed alone or combined with cataract extraction and intraocular lens (IOL) implantation to reduce preoperative corneal astigmatism. The use of LRI’s to treat astigmatism that is not surgically induced is considered not medically necessary. Although there are numerous reports of AK that has been performed in patients, there are few well controlled prospective clinical studies available on AK either performed alone or in connection with other keratorefractive procedures. (3, 14, 15)

A Medline search through December 2016 identified studies related to AK. All applicable studies were small sample sizes therefore do not change the overall coverage position related to AK.

The 2013 AAO Preferred Practice Pattern on Refractive Errors states: "[T]here are few well-controlled, prospective clinical studies available on the procedure to date, performed either individually or in connection with other keratorefractive procedures". (3)

Automated lamellar keratoplasty (ALK) or standard keratomileusis

The 2013 AAO preferred practice pattern on Refractive Errors assessment states that ALK had only fair predictability and has been largely abandoned due to the advent of laser- in-situ keratomileusis (LASIK). (3)

Conductive keratoplasty (CK), (thermal keratoplasty)

Few case series with small sample sizes (n=10-27) have examined CK to be safe and effective for symptomatic presbyopia. (16, 17) A larger series by McDonald et al. (18) in 2004 reported preliminary results of a multicenter clinical trial supported by the FDA to evaluate the effectiveness of CK for the treatment of presbyopic symptoms of emmetropic and hyperopic eyes. A total of 143 patients were enrolled in this 1-year study and treated to improve near vision in 1 eye (unilateral treatment). In addition, 33 fellow eyes were treated to improve distance vision (bilateral treatment). At 6-month follow-up, 77% of examined eyes had J3 or better monocular distance vision with uncorrected visual acuity (UCVA). Eighty-five percent of patients had binocular UCVA of 20/25 or better distance along with J3 or better near, a combination that represents functional acuity for a presbyopic individual. Of eyes treated with CK, 92% had an uncorrected binocular vision of 20/32 and J5, which also allows a high degree of uncorrected visual function. It was noted that follow-up was too short for meaningful determination of refractive stability. Follow-up to 3 years and beyond would be needed for accurate determination of stability.

In 2014, Moshirfar et al. (19) assessed the regression rate of CK in patients with or without previous LASIK or PRK. This retrospective, age-matched chart review identified records of 6 patients who underwent CK after refractive surgery and 12 patients who underwent CK without prior refractive surgery. The main outcome measures were postoperative uncorrected and corrected visual acuities and refraction changes over time. Preoperatively, the mean manifest refraction spherical equivalent (MRSE) of the 15 eyes (12 patients) that underwent CK without refractive surgery was 0.83 diopters (D) and the 7 eyes (6 patients) that underwent CK after refractive surgery had an average MRSE of 0.27 D. Postoperatively, the mean MRSE of the refractive surgery patients was -0.86 D at 6 months, regressing to -0.67 D at 12 months. The postoperative MRSE in the eyes without refractive surgery was -0.58 D. at 6 months, regressing to -0.38 D at 12 months. The rate of regression was linear in both groups, calculated at 0.033 D per month in all patients. Patients with previous LASIK or PRK showed a greater treatment response to CK but regressed at a similar rate as those eyes without prior LASIK or PRK. Overall CK is a safe procedure that inevitably regresses.

Currently there is insufficient evidence in the peer reviewed literature to support the effectiveness of this treatment.

Epikeratoplasty (epikeratophakia)

The 2013 AAO Preferred Practice Pattern on Refractive Errors and Reactive Surgery states epikeratophakia may be indicated for the treatment of childhood aphakia since contact lenses are difficult for children to use and IOL implants may result in long-term complications in children. In addition, although secondary implantation of an IOL is the favored treatment of adult aphakia, there are circumstances where reentering the eye could affect the overall outcome (e.g., vitreous in the anterior chamber, history of uveitis, disorganized anterior chamber that cannot support an intraocular lens, significant corneal endothelial disease, or gross corneal irregularity after trauma); in these cases of adult aphakia, epikeratophakia may be considered acceptable. This procedure has not been proven to be effective for the correction of refractive errors and for all other cases of adult aphakia. In 2013, the AAO published a document related to epikeratoplasty states, “Refractive results are variable and significant complications can occur. These include poor incision healing, irregular astigmatism, interface haze, lenticule necrosis and microbial keratitis. This procedure has been largely abandoned for refraction correction”. (3)

Hexagonal keratotomy (HK)

Hexagonal keratotomy (HK) is a surgical incisional technique to correct hyperopia.

In 2012, Mehta et al. noted complications that were previously reported following HK, including irregular astigmatism, wound healing abnormalities and corneal ectasia. When visual acuity is poor because of ectasia or irregular astigmatism and contact lens fitting is not possible, penetrating or lamellar keratoplasty can be performed. Since incisions in refractive keratotomy are set at 90-95% depth of cornea, intraoperative microperforations are known to occur and lamellar keratoplasty may become difficult. Deep anterior lamellar keratoplasty (DALK) can be used to successfully manage keratectasia after HK. (20) Hexagonal keratotomy is now rarely used since newer techniques in refractive surgery have been developed.

A Medline search through December 2016 identified no additional randomized controlled studies that would support a change the overall coverage position related to HK.

Keratophakia

Keratophakia is not addressed in the 2013 AAO Preferred Practice Pattern on Refractive Errors and Reactive Surgery and there is a lack of studies evaluating keratophakia for refractive errors. The correction of keratophakia for correction of refractive errors has not been proven in the peer reviewed medical literature. (3) A Medline search through December 2016 did not identify any additional studies related to Keratophakia.

Laser-in-situ keratomileusis (LASIK)

In 1999, The U.S. FDA approved Lasik. Since then, the FDA has granted approval of additional devices for Lasik to treat myopia, hyperopia and astigmatism and for PRK to treat hyperopia and astigmatism. In 2014, the FDA provided patient information regarding which lasers have received FDA approval with the specific treatment ranges for each laser, instructions for use and any changes to the devices since they were approved by the FDA. (21)

The 2013 AAO guidelines state the data from published studies fail to demonstrate a relationship between pupil size and the quality of post-operative vision therefore the pupillometry in the preoperative period remains controversial and wave front guided LASIK has not shown a relationship between the diameter of the low light pupil and disturbing visual symptoms postoperatively. Irrespective of pupil size, it is important for potential patients to understand the risks for night vision problems after surgery. A benefit of more complex aspheric ablations relative to conventional ablations may be found under low light conditions when the pupil is dilated, because this is when a reduction, or less inductions of higher-order aberrations (HOAs) occur. (3, 22, 23, 24) They note that excimer ablations can result in very thin residual stroma, which can increase the risk for ectasia. In the case of LASIK, 250um were suggested as a safe residual stromal bed thickness. (25) Research is ongoing to determine if personality characteristics can affect patient outcomes. Depressive symptoms have been associated with decreased patient satisfaction with visual quality after LASIK. (26) This study is consistent with studies from the cosmetic surgery literature, which identified the presence of a personality disorder or a history of depression or anxiety as predictors for poor psychological and psychosocial outcome. (27).

In a large series of 1062 eyes in 574 myopic patients, Stutling et al. reported that complications occurred in 5% of patients. Complications included corneal flap complications, epithelial in-growth or keratitis. There was a reduction in best-corrected visual acuity in 50 patients. Among 148 eyes with preoperative myopia greater than 10 diopters (i.e., severe myopia), 8.8% lost more than two Snellen lines of visual acuity. Additionally, 26% of eyes in this group underwent repeat LASIK procedures. (28)

Perez-Santonja et al. reported a case series of 143 eyes with high myopia. Preoperatively the mean best-corrected visual acuity (BCVA) was 0.51, while the postoperative BCVA was 0.59, a difference that did not reach statistical significance. The mean postoperative uncorrected visual acuity was 0.47, less than the preoperative BCVA. Results with photorefractive keratectomy for high myopia may be worse; case series have reported losses of BCVA in from 0 to 33% of cases. Longer follow-up is necessary to evaluate long-term incidence of vision-threatening complications. (29)

Hersh et al. reported on the results of a study that randomized 220 patients with moderate to high myopia to undergo either PRK or LASIK. At all-time point studies, relatively more patients in the PRK group lost two Snellen lines or more compared to the LASIK group. The differences in the pre- and postoperative BCVA were not reported for those with high myopia. (30)

In 2013, Fernández-Buenaga completed a study to evaluate the efficacy, predictability, and safety of three different procedures (intraocular lens [IOL] exchange, piggyback lens implantation, and LASIK) to correct residual refractive error following cataract surgery. A retrospective multicenter study comprised 65 eyes of 54 patients that underwent phacoemulsification, resulting in a unacceptable final refractive error. Eyes were divided into three groups: eyes that had an IOL lens exchange (17 eyes), eyes that had a piggyback lens implanted (20 eyes), and eyes that had LASIK (28 eyes). The study determined there was no differences between the IOL exchange and piggyback lens groups in the spherical equivalent, sphere, or cylinder were found (P = .072, .436, and .081, respectively). The LASIK group showed a statistically significant reduction in spherical equivalent and refractive cylinder when compared with the IOL exchange group (P < .001 and P = .001, respectively). The LASIK group showed statistically significant reduced refractive cylinder in comparison with the piggyback lens group (P = .002). The median efficacy index was 0.58 (range: 0.28 to 0.93), 0.75 (range: 0.65 to 0.92), and 0.91 (range: 0.85 to 1.14) in the IOL exchange, piggyback lens, and LASIK groups, respectively. Statistically significant differences were found between the IOL exchange and LASIK groups (P = .004) and the piggyback lens and LASIK groups (P = .003). No statistically significant differences were detected in the safety index among groups (P = .094). The predictability (±1 diopters of final spherical equivalent) was 62.5% of eyes in the IOL exchange group, 85% of eyes in the piggyback lens group, and 100% of eyes in the LASIK group. This study determined that the 3 procedures were effective. The LASIK group showed the best overall outcome in efficacy and predictability. (31)

In 2012, Ivarsen et al. compared the long-term changes in corneal power and aberrations in myopic patients randomized to PRK or LASIK. (32) Forty-five patients with myopia from -6 to -8 diopters (spherical equivalent refraction) were randomized to either PRK (n = 20) or LASIK (n = 25). Patients were examined preoperatively and for up to 7 years following surgery. Measurements included refraction, topography, and ultrasound pachymetry. At 3 years, 16 PRK and 15 LASIK patients were examined and at 7 years, 9 PRK and 7 LASIK subjects were examined. Only patients who had not been reoperated and attended the two late controls were included in the data analyses. Optical analysis of topographic data was used to calculate corneal power and wavefront aberrations. During the first year after PRK, corneal power increased, but remained stable from 1 to 7 years. In contrast, corneal power continued to increase from 1 to 7 years after LASIK. Both PRK and LASIK caused an increase in coma-like and spherical aberrations that remained constant for 7 years. No significant changes in other higher-order aberrations were observed. The study concluded that the cornea may not be stable even 7 years after LASIK, as indicated by the continuing increase in corneal power. In contrast, PRK appears stable from 1-year following surgery. Coma-like and spherical aberrations are permanently increased after PRK and LASIK.

Minimally invasive radial keratotomy (mini-RK)

In 1995, Lindstrom et al. determined ocular incisions do not need to be carried to the limbus to achieve a near maximal effect. The effects are similar for radial incisions from a 3-mm clear zone carried to a 7- to 8-mm optical zone (mini-RK) and for those carried to an 11-mm optical zone. In fact, a mean increase of only 7.7% was seen when incisions were extended from the 7- to 11-mm optical zone. Thus, doubling the length of the RK incision achieved an additional effect of only 7.7%. With the use of the mini-RK procedure, the shorter incisions maintain the structural integrity of the cornea which may minimize the more serious complications and side effects of RK. Thus, the use of minimally invasive RK (mini- RK) may retain the benefits of RK for lowest to moderate myopes while significantly reducing the risks. (33)

A Medline search through December 2016 identified no additional randomized controlled trials related to mini-RK; therefore, there is no change the overall coverage position related to mini-RK.

Orthokeratology (ortho-K)

Ortho-K involves the application of hard contact lenses to flatten the cornea and thereby reduce myopic refractive errors. Orthokeratology has not been proven to be effective for the treatment of refractive errors. (34)

In 2008, Van Meter et al. (2008) reviewed the published literature to evaluate the safety of overnight orthokeratology (OOK) for the treatment of myopia. Repeated searches of peer-reviewed literature were conducted from controlled trials beginning 2005 through 2007 resulting in 495 citations. Seventy-five articles were determined to be relevant to the assessment objective. No study was rated as having level I evidence. Two pre-market applications to the FDA and two studies were rated as having level II evidence. The main source of reports of adverse events associated with OOK was 38 case reports or non-comparative case series (level III evidence). The authors concluded that the prevalence and incidence of complications associated with OOK have not been determined. Complications, including more than 100 cases of infectious keratitis resulting from gram-positive and gram-negative bacteria and Acanthamoeba, have been described in case reports and case series representing observations in undefined populations of OOK users. Data collection was non-standard and risk factors for various complications could not be determined. Because OOK puts patients at risk for vision-threatening complications they may not encounter otherwise, sufficiently large well-designed cohort or randomized controlled trials (RCT) are needed for adults and children to provide a more reliable measure of the risks of treatment and to identify risk factors for complications. Due to the variations in orthokeratology practice, a wide margin of safety should be incorporated into OOK regimens. (34)

Penetrating keratoplasty (PK)

The 2009 National Institute for Clinical Excellence (NICE) Guidelines for Corneal endothelial transplantation indicate the current surgical treatment for corneal endothelial disease is PK (whole cornea transplantation). PK is considered a standard surgical intervention for corneal conditions such as bullous keratopathy, Fuchs' dystrophy, trauma, infection and iatrogenic damage. (35, 36) Injury or disease can cause corneal opacity. Some diseases may include autoimmune diseases, bullous keratopathy, keratoconus, keratitis and corneal stromal dystrophies. (36) Lamellar keratoplasty shows promise as an alternative procedure to PK, particularly for those corneal conditions not affecting the endothelium, although the procedure has not been proven to be equal or superior to PK.

The 2013 AAO states “PK is one of the most common therapeutic options for individuals with corneal edema and reduced vision or significant pain due to bullous keratopathy. Factors that determine whether full-thickness or lamellar surgery is to be recommended include the presence and extent of sub epithelial or stromal scarring, concerns about the impact of ocular surface disease on epithelial healing and stability, and the extent of any reconstructive intraocular surgery that might be necessary at the time of surgery”. (37)

PK has not been proven to be effective for correcting astigmatism or other refractive errors.

Photoastigmatic keratectomy (PARK or PAK-A) photorefractive keratectomy (PRK)

PRK is approved for the treatment of myopia up to -13.0 diopters (D) and astigmatism up to -4.5 D, depending on the type of laser utilized. PRK is more predictable in patients with a lower degree of myopia (<6.0 D) than patients with a higher degree of myopia who are treated with Patients with a higher degree of myopia who are treated with PRK tend to have more regression of their refractive effect, and more significant haze. (38)

Radial keratotomy (RK)

RK is a surgical procedure that is performed infrequently since the advent of PRK and Lasik. The results of RK typically are best in patients with low to moderate myopia (up to -6.0 D). (39)

In 1991, Waring et al. published a 5-year Prospective Evaluation of RK (PERK) study. This was a multicenter study aimed at evaluating the long term effects after RK. Seven hundred ninety-three eyes of 435 patients with 2 to 8 diopters (D) of myopia received a standardized surgery consisting of 8 incisions with a diamond-bladed knife set at 100% of the thinnest paracentral ultrasonic corneal thickness measurement and a diameter of the clear zone of 3.0 to 4.5 mm; 97 eyes (12%) received an additional 8 incisions. There were 757 eyes (95%) followed for 3 to 6.3 years. After surgery, uncorrected visual acuity was 20/40 or better in 88% of eyes. The refractive error was within 1 D of emmetropia for 64% of eyes; 19% were myopic and 17% were hyperopic by more than 1 D. Between 6 months and 5 years after surgery, 22% of the eyes had a refractive change of 1 D or more in the hyperopic direction. For 25 eyes (3%) there was a loss of 2 or more lines of best spectacle-corrected visual acuity. (40) At the 10-year follow-up, the major finding was the instability of the refractive error; 43% of eyes changed refractive power in the hyperopic direction, termed hyperopic shift (41).

Refractive lamellar keratoplasty and/or non-penetrating keratoplasty

Refractive lamellar Keratoplasty or non-penetrating keratoplasty is a partial thickness corneal transplant procedure with a partial-thickness donor cornea. Therapeutically, lamellar keratoplasty and/or non-penetrating keratoplasty may be indicated for a number of corneal diseases to include corneal scarring, edema, thinning, distortion, dystrophy, degenerations and keratoconus otherwise it is considered not medically necessary for astigmatism and/or refractive errors. It has not been proven to be effective for correction of astigmatism and other refractive errors. (11)

Refractive lensectomy

In 2003, the AAO published a position regarding Refractive Surgery for Myopia, Myopic Astigmatism, and Mixed Astigmatism. Refractive lensectomy is when the eyes’ natural lens is removed and replaced with an artificial intraocular lens (IOL) to alter the refractive state of the eye. This surgical procedure has been shown to be safe and efficacious. However, studies of refractive surgical procedures have shown that eyeglasses or contact lenses provide more accurate corrections of refractive errors in non cataractous patients. Refractive lensectomy has been used for the correction of myopia, hyperopia, and presbyopia. Refractive lensectomy is a viable option for refractive correction at high extremes of ametropia, but caution should be exercised in cases of high axial myopia. Refractive lensectomy is a good option for patients who have corneas too thin or irregular for corneal refractive surgery. Furthermore, patients with evidence of early nuclear sclerosis may be better candidates for refractive lensectomy if cataract extraction would be anticipated in the next several years. (38)

Scleral expansion

The 2004, the National Institute for Clinical Excellence (NICE) Guidelines for Scleral Expansion Surgery indicate that all studies identified were of poor quality and current evidence on the safety and efficacy of scleral expansion surgery for presbyopia is very limited. Evidence was limited to 1 non-randomized controlled study (n=29), 2 very small case series (n=3, n=6) and 2 case reports. There is no evidence of efficacy in the majority of patients. There are also concerns about the potential risks of the procedure which include intraocular hemorrhage, retinal detachment, endophthalmitis, glaucoma, conjunctival scarring and scleral thinning. NICE guidelines state” It is recommended that this procedure should not be used.” (42)

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

0290T, 65710, 65730, 65750, 65755, 65760, 65765, 65767, 65771, 65772, 65775, 66999, [Deleted 1/2017: 0289T]

HCPCS Codes

S0800, S0810.

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

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2. Astigmatic keratotomy eye surgery. WebMD. Available at <http://www.webmd.com> (accessed January 9, 2017).

3. American Academy of Ophthalmology. Preferred practice pattern: refractive errors & refractive surgery. San Francisco, California. Sept 2013; Available at <http://www.aao.org> (accessed January 10, 2017).

4. Thompson Vance. Conductive keratoplasty (CK) reduces need for reading glasses. Available at < http://www.allaboutvision.com> (accessed January 10, 2017).

5. Kirkpatrick C., Kitzman A., et al. Hexagonal keratotomy, University of Iowa Healthcare (2013). Available at < http://www.webeye.ophth.uiowa.edu> (accessed January 10, 2017).

6. Chen W, Guo CL, Zhang PS, et al. Laser In-situ keratomileusis (LASIK). Available at <http://www.surgeryencyclopedia.com> (accessed January 10, 2017).

7. Chu Y, Harden D, Thomas D, et al. Radial keratotomy. 1 (41). Available at <http://www.oculist.net> (accessed January 10, 2017).

8. All about vision, glossary of vision terminology (2016). Access Media group, LLC. Available at <http://www.allaboutvision.com> (accessed January 25, 2017).

9. Wachler B. Corneal transplants: What to expect. Available at <http://www.allaboutvision.com> (accessed January 10, 2017)

10. Steinert, R., McColgin, A. et al. Surface Ablation: Photorefractive Keratectomy, Lasek, and Epi-LASEK, volume 6 (48). Available at <http://www.oculist.net> (accessed January 25, 2017).

11. National Eye Institute: Facts about the cornea and corneal disease (May 2016). Available at <https://nei.nih.gov> (accessed 1/26/2017).

12. Wachler B. Refractive Lens Exchange: Lens Replacement Surgery (September 2016). Available at <http://www.allaboutvision.com> (accessed January 26, 2017)

13. American Optometric Association (AOA). Refractive Surgery and Corneal Modification Definitions: (2017). Available at <http://www.aoa.org> (accessed January 26, 2017).

14. Agapitos PJ, Lindstrom RL, Williams PA, et al. Analysis of astigmatic keratotomy. J Cataract Refractory Surgery 1989; 15; 13-8. PMID: 2921730

15. Deg, JK, Binder PS, et al, Wound healing after astigmatic keratotomy in human eyes. Ophthalmology 1987; 94:1290-8. PMID: 3317181

16. Ye P, Xu W, Tang X, et al. Conductive keratoplasty for symptomatic presbyopia following monofocal intraocular lens implantation. Clinical & Experimental Ophthalmology. Jul 2011; 39(5):404-11. PMID: 21070548

17. Stahl JE. Conductive keratoplasty for presbyopia: 3-year results. Journal of Refractive Surgery. 2007 Nov; 23(9):905-10. PMID: 18041244

18. McDonald MB, Durrie D, Asbell P, et al. Treatment of presbyopia with conductive keratoplasty: six-month results of the 1-year United States FDA clinical trial. Cornea. Oct 2004; 23(7):661-8. PMID:15448490

19. Moshirfar M, Anderson E, Hsu M, et al. Comparing the rate of regression after conductive keratoplasty with or without prior laser-assisted in situ keratomileusis or photorefractive keratectomy. Middle East African Journal of Ophthalmology. 2012 Oct; 19(4):377-81. PMID: 23248539

20. Mehta p, Rathi VM, Murthy SI, et al. Deep anterior lamellar keratoplasty for the management of iatrogenic keratectasia occurring after hexagonal keratotomy. Indian Journal of Ophthalmology. Mar-Apr 2012; 60(2):139-41.

21. FDA-Approved Lasers for LASIK / Patient Information. Food and Drug Administration – Center for Devices and Radiologic Health (2014). Available at <http://www.fda.gov> (accessed January 29, 2017).

22. Pop M, Payette Y, et al. Risk Factors for Night Vision Complaints After LASIK for Myopia. Ophthalmology 2004; 111; 3-10. PMID:14711706

23. Schallhorn SC, Kaupp SE, Tanzer DJ, et al. Pupil size and quality of vision after LASIK. Ophthalmology 2003; 110:1606-14. PMID: 12917181

24. Villa C, Gutiérrez R, Jiménez JR, et al. Night vision disturbances after successful LASIK surgery. Ophthalmology 2007; 91:1031-7. PMID: 17314153

25. Seiler T, Koufala K, Richter G, et al. Iatrgenic keratectasia after laser in situ. Journal of Refractive Surgery. 1998; 14:312-7. PMID: 9641422

26. Morse JS, Schallhorn SC, Hettinger K, et al. Role of depressive symptoms in patient satisfaction with visual quality after laser in situ keratomileusis. Journal of Cataract & Refractive Surgery. 2009; 35:341-6. PMID: 19185253

27. Honigman R, Phillips K, Castle D, et al. A review of psychosocial outcomes for patient’s seeking cosmetic surgery. Plastic Reconstructive Surgery. 2004; 113:1194-201. Available at <http://www. ncbi.nlm.nih.gov> (accessed January 30, 2017).

28. Stutling, R.D., Carr, J.D., Thompson KP, et al. Complications of laser in situ keratomileusis for the correction of myopia. Ophthalmology. 1999; 106:13-20. PMID: 9917775

29. Pérez-Santonja JJ, Bellot J, Claramonte P, et al. Laser in situ keratomileusis to correct high myopia. Journal of Cataract Refractive Surgery. 1997; 23:372-85. PMID: 9159682

30. Hersh, PS, Brint, SF, Maloney RK, et al. Photorefractive keratectomy versus laser in situ keratomileusis for moderate to high myopia. Ophthalmology. 1998; 105:1512-23. PMID: 9709767

31. Fernández-Buenaga R, Alió JL, Pérez Ardoy AL, et al. Resolving refractive error after cataract surgery: IOL exchange, piggyback lens, or LASIK. Journal Refractive Surgery. November 2013; 29(11):796. PMID: 23991761

32. Ivarsen A, Hjortdal J. Seven-year changes in corneal power and aberrations after PRK or LASIK. Investigative Ophthalmology & Visual Science. 2012 Sep 6; 53(10):6011-6. PMID: 22879417

33. Lindstrom RL. Minimally invasive radial keratotomy: mini-RK. J Cataract Refractory Surgery. 1995; 21:27. PMID: 7722894

34. Van Meter WS, Musch DC, Jacobs DS, et al. American Academy of Ophthalmology, safety of overnight orthokeratology for myopia: a report by the American Academy of Ophthalmology. Ophthalmology. December 2008; 115(12):2301-2313. PMID: 18804868

35. National Institute for Health and Clinical Excellence (NICE). Corneal endothelial transplantation. (2009 June). Available at <http://www.nice.org.uk> (accessed February 1, 2017).

36. National Institute for Health and Clinical Excellence (NICE). Interventional procedures programme: Interventional procedure overview of implantation of a corneal graft-Keratoprosthesis for severe corneal opacity in wet blinking eyes. (2015 January). Available at <http://www.nice.org.uk> (accessed February 1, 2017).

37. American Academy of Ophthalmology. Preferred practice pattern: Corneal edema and opacification. San Francisco, California. September 2013; Available at < http://www.aao.org> (accessed February 7, 2017).

38. Anderson, N, Davis E, Hardten D, et al. Refractive Surgery for Myopia, Myopic Astigmatism, and Mixed Astigmatism. American Academy of Ophthalmology (AAO). Refractive Management. (2003) Volume 1; module 1. Available at < http://www.aao.org> (accessed February 6, 2017)

39. Waring GO 3rd, Lynn MJ, Fielding B, et al. Results of the Prospective Evaluation of Radial Keratotomy (PERK) study 4 years after surgery for myopia. Perk Study Group. JAMA 1990; 263:1083–1091. PMID: 2405203

40. Waring GO 3rd, Lynn M, Nizam A, et al. Results of the Prospective Evaluation of Radial Keratotomy (PERK) Study five years after surgery. The Perk Study Group. PERK study Group. Ophthalmology 1991 August; 98(8):1164-76. PMID: 1923352

41. Waring GO 3rd, Lynn MJ, Nizam A, et al. Results of the Prospective Evaluation of Radial Keratotomy (PERK) Study 10 years after surgery. The Perk Study Group. PERK study Group. Ophthalmology 1994; 112(10):1298-1308. PMID: 1923352

42. National Institute for Clinical Excellence (NICE). Scleral expansion surgery for presbyopia. Interventional Procedure Guidance No. 70. (July 2004). Available at <http://www.nice.org.uk> (accessed February 6, 2017).

43. Vision – Archived. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (February 2011) Other 9.03.02.

Policy History:

Date Reason
7/15/2018 Reviewed. No changes.
4/1/2017 Document updated with literature review. Coverage unchanged.
1/1/2015 Document updated with literature review. The following was added to the coverage position: Hexagonal Keratotomy (HK), Orthokeratology (Ortho-K), Scleral Expansion surgery, and Standard Keratomileusis are refractive procedures that are considered not medically necessary. In addition, some content on this medical document was moved to new policies: 1) Content related to Endothelial Keratoplasty is now located on OTH903.029; 2) Content related to Keratoprosthesis is now located on OTH903.001.
9/15/2012 Document updated with literature review. The following was added endothelial keratoplasty (EK), Descemet’s stripping endothelial keratoplasty (DSEK); Descemet’s stripping automated endothelial keratoplasty (DSEAK), or Descemet’s membrane endothelial keratoplasty (DMEK) or Descemet’s membrane automated endothelial keratoplasty (DMAEK) may be considered medically necessary for the treatment of endothelial dysfunction, including but not limited to Fuchs’ endothelial dystrophy, aphakic, and pseudophakic bullous keratopathy, and failure or rejection of a previous corneal transplant.
11/1/2011 CPT/HCPCS code(s) updated
8/15/2011 CPT/HCPCS code(s) updated
12/15/2010 The following was removed. Intrastromal corneal ring segments (INTACS) when inserted to avoid corneal graft surgery in individuals with keratoconus are considered to be experimental, investigational and unproven. (Coverage is unchanged. This topic is now addressed on new medical policy SUR713.031, Implantation of Intrastromal Corneal Ring Segments.)
6/1/2010 Coverage revision to include PRK for Anisometropic Amblyopia as not medically necessary. Descemetocele added to indications for corneal transplant.
1/1/2009 New CPT/HCPCS code(s) added
7/15/2008 Revised/updated entire document. Coverage revised. Rationale revised. References revised. CPT/HCPCS code(s) updated. Title revised. This policy is no longer scheduled for routine literature review and update.
3/15/2006 Revised/updated entire document.
3/1/2000 Revised/updated entire document.
6/1/1998 Revised/updated entire document
9/1/1996 Revised/updated entire document
1/1/1996 Revised/updated entire document
4/1/1993 Revised/updated entire document
10/1/1992 Revised/updated entire document
6/1/1991 Revised/updated entire document
5/1/1996 Revised/updated entire document
3/1/1990 New medical document

Archived Document(s):

Title:Effective Date:End Date:
Refractive and Therapeutic Keratoplasty04-01-201707-14-2018
Refractive and Therapeutic Keratoplasty01-01-201503-31-2017
Refractive and Therapeutic Keratoplasty09-15-201212-31-2014
Refractive and Therapeutic Keratoplasty11-01-201109-14-2012
Refractive and Therapeutic Keratoplasty08-15-201110-31-2011
Refractive and Therapeutic Keratoplasty12-15-201008-14-2011
Refractive and Therapeutic Keratoplasty06-01-201012-14-2010
Refractive and Therapeutic Keratoplasty07-15-200805-31-2010
Refractive Keratoplasty04-15-200807-14-2008
Refractive Keratoplasty03-15-200604-14-2008
Refractive Keratoplasty03-01-200003-14-2006
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