How To Treat A Cornea Transplant

Transcription

1 National Medical Policy Subject: Refractive Surgery (LASIK, LASEK, PRK, PARK and PRK-A) Policy Number: NMP391 Effective Date*: November 2007 Update: January 2015 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for coverage guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link X National Coverage Determination (NCD) Refractive Keratoplasty (80.7): National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* X Other Medicare Learning Network Matters. Ophthalmology Resource Information: Education/Medicare-Learning-Network- MLN/MLNProducts/ophthalmology.html MLN Matters Number: MM5527 Revised Related Change Request (CR) April 27, Updated August 22, 2012: Education/Medicare-Learning-Network- MLN/MLNMattersArticles/downloads/mm5527.pdf Medicare. National Government Services. Jurisdiction B DME MAC Supplier Manual: Chapter 15 December Updated December 2012: Refractive Surgery Jan 15 1

2 a0b0-4e e28518c31ae/197_1212_JBC_nolinks_508.pdf?MOD =AJPERES&CACHEID=6f6d8832-a0b0-4e e28518c31ae None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Please refer to the National Medical Policy on Intrastromal Corneal Rings for Kerataconus (INTACS) Health Net, Inc, considers refractive surgery medically necessary in a very small number of patients who meet any of the following: 1. Laser in situ keratomileusis (LASIK), laser epithelial keratomileusis (LASEK), photorefractive keratectomy (PRK), and photoastigmatic keratectomy (PARK or PRK-A) when any of the following is met: Prior cataract, corneal, or scleral buckling surgery for retinal detachment has been performed on the eye and all of the following are met: The medical record documents symptoms due to aniseikonia (different sizes/shapes of ocular images between the eyes) or anisometropia (a large difference in refractive error [spectacle prescription] between the two eyes); and The medical record documents inadequate functional vision with contact lenses and spectacles (eyeglasses); and The post-operative refractive error has changed by > 3 diopters (D) between the eyes when compared to the preoperative refractive error; and Lens implant is impractical. Following a corneal transplant for trauma, infection, keratoconus (irregular corneal surface [cone-shaped]) or a complication of surgery resulting in blurred Refractive Surgery Jan 15 2

3 and distorted images when all of the following are met: The patient is left with significant astigmatism (blurred vision caused by irregularities in the cornea or lens) of > 3 diopters); and Patient can t function with glasses and contact lenses are intolerable; and Testing has concluded that patient will function better 2. Epikeratoplasty (epikeratophakia) for either of the following conditions: Correction of refractive errors of acquired or congenital aphakia (absence of the crystalline lens); or Hypermetropia (hyperopia, farsightedness) following cataract surgery in patients unable to receive an intraocular lens. 3. Phototherapeutic keratectomy (PTK) when any of the following is met: Scarring and opacities of the cornea (including post-traumatic, post-infectious, post-surgical, and secondary to pathology); or Irregular corneal surface due to Salzmann's Nodular Degeneration; or Epithelial membrane dystrophy; or Superficial corneal dystrophy (including granular, lattice, and Reis-Buckler's dystrophy); or Recurrent corneal erosions when other surgical treatments (such as mechanical superficial keratectomy or anterior stromal micropuncture) have been shown to be unsuccessful. 4. Correction of surgically-induced astigmatism (blurred vision caused by irregularities in the cornea or lens) with a corneal relaxing incision or corneal wedge resection when all of the following are met: Patient has had previous penetrating keratoplasty (corneal transplant) within the past 60 months or cataract surgery within the last 36 months; and The degree of astigmatism is > 3 diopters; and The patient is intolerant of glasses and contact lenses. Health Net, Inc. considers any of the following refractive procedures not medically necessary since more conservative measures (e.g., glasses or contact lenses) can correct the vast majority of refractive errors. Some are investigational because scientific evidence is lacking concerning their effectiveness: LASIK, LASEK, PRK, PARK or PRK-A, except as previously indicated Epikeratoplasty (epikeratophakia), except as previously indicated Refractive Surgery Jan 15 3

4 Correction of surgically induced astigmatism with a corneal relaxing incision or corneal wedge resection, except for the small subset of patients noted above PTK for treatment of infectious keratitis Laser thermal keratoplasty (LTK) Radial keratotomy Astigmatic keratotomy Hexagonal keratotomy Mini-radial keratotomy (mini-rk) Conductive keratoplasty to treat presbyopia (i.e., ViewPoint CK System) Keratophakia Orthokeratology Standard keratomileusis, also known as automated lamellar keratomileusis (ALK) Keratoprosthesis Lamellar keratoplasty (nonpenetrating keratoplasty) Tectonic or optic keratoplasty Penetrating keratoplasty (PK) (corneal transplantation, perforating keratoplasty) Implantable contact lenses (without lens extraction) (phakic intraocular lenses) including, but not limited to, Artisan Phakic Intraocular Lens, also known as Veriaye Phakic Intraocular Lens, and Visian ICL (Implantable Collamer Lens) Clear lens extraction (CLE) with or without implantation of an accommodating or nonaccommodating lens or insertion of so called intraocular contact lenses (ICL) Intracorneal inlays Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2015 implementation date. ICD-9 Codes Hypermetropia Myopia Astigmatism Anisometropia Aniseikonia Corneal scars and opacities Refractive Surgery Jan 15 4

5 Nodular degeneration of cornea Juvenile epithelial corneal dystrophy Other anterior corneal dystrophies Macular corneal dystrophy Irregular astigmatism Aniseikonia Central Corneal Opacity Blood staining of cornea Corneal edema Idiopathic corneal edema Secondary corneal edema Bullous keratopathy Recurrent erosions of cornea Keratoconus unspecified Keratoconus stable Keratoconus acute hydrops Corneal deformity unspecified Corneal ectasia Descemetocele Corneal Staphyloma Aphakia (acquired) Buphthalmos unspecified Congenital aphakia Corneal opacities congenital Mechanical complication of other specified prosthetic device, implant and graft, due to corneal graft V42.5 Cornea replaced by transplant V43.1 Organ or tissue replaced by other means, lens V45.61 Cataract extraction status ICD-10 Codes H15- Disorders of the sclera H15.9 H16- Keratitis H16.4 H16.3- Interstitial and deep keratitis H16.9 H17- Corneal scars and opacities H17.9 H Posterior corneal pigmentations, unspecified eye H18.13 Bullous keratopathy, bilateral H18.20 Unspecified corneal edema H Idiopathic corneal edema, unspecified eye H Secondary corneal edema, unspecified eye H18.30 Secondary corneal edema, unspecified eye H Keratoconus, unspecified, unspecified eye H Corneal staphyloma, unspecified eye H Recurrent erosion of cornea, unspecified eye H25.0- Age related cataract H25.9 H26- Other Cataract Refractive Surgery Jan 15 5

6 H26.09 H26.1- Complicated cataract H H Cataract secondary to ocular disorders H H Glaucomatous flecks H239 H26.3- Dug induced cataract H26.33 H26.4- Secondary cataract H H27.03 Aphakia, bilateral H28 Cataract in diseases classified elsewhere H52- Disorders of refraction and accommodation H52.7 Q10- Congenital malformation of eyelid, lacrimal apparatus and orbit Q15.9 T85.2- Mechanical complication of intraocular lens, prosthetic devices, T implants, and grafts Z94.7 Corneal transplant status Z98.4- Mechanical complication of intraocular lens, prosthetic devices, Z98.42 implants, and grafts Z98.49 Mechanical complication of intraocular lens, prosthetic devices, implants, and grafts CPT Codes Keratomileusis Corneal relaxing incision for correction of surgically induced astigmatism Corneal Wedge resection for correction of surgically induced astigmatism Unlisted Procedure, anterior segment of eye 0099T Implantation of intrastromal corneal ring segments HCPCS Codes S0800 Laser in situ keratomileusis (LASIK) S0810 Photorefractive keratectomy S0812 Phototherapeutic keratectomy (PTK) Scientific Rationale Refractive errors occur when light entering the eye does not focus on the retina. They are normal differences in visual ability rather than true diseases. The three basic types of refractive errors are myopia, hyperopia, and astigmatism. Refractive errors are the most frequent eye problems in the United States. Nearly half of the U.S. population requires vision correction of some kind at a cost of more than $15 billion annually. Since the Food and Drug Administration (FDA) approved the first excimer laser for refractive surgery in 1995, laser eye surgery has been performed on more than 6 million people worldwide. Almost 2 million more are expected to undergo treatment in the coming year. In myopia, the cornea and lens are too powerful for the length of the globe. Distant objects cannot be seen clearly because light rays are focused in front of the retina. However, Refractive Surgery Jan 15 6

7 because the myopic eye has a focal point close to the eye, near objects can be seen clearly without corrective lenses, hence the term nearsighted. In hyperopia, the cornea and lens are too weak or the eyeball is too short. Light rays reach the retina before they are focused to a single point, resulting in a blurry image. Accommodation may bring a distant object into focus but may be inadequate for near vision, hence the term farsighted. Astigmatism often occurs with either myopia or hyperopia. It is an irregular curvature of the cornea in which the refractive power of the eye varies in different meridians. Light rays cannot be brought to a single point, and objects are blurry at any distance. Another refractive problem, presbyopia, occurs as the aging lens loses its ability to accommodate. This change occurs in everybody, usually around age 45 years, resulting in eyestrain with prolonged near work. Myopes frequently notice that it is easier to remove their glasses to read. Hyperopes who rely on accommodation have increasing difficulty focusing. Once presbyopia develops, additional focusing power is necessary in the form of reading glasses or bifocals. Corrective lenses alter the path of light rays entering the eye. Myopia is treated with concave lenses with minus (divergent) power. Hyperopia requires convex lenses with plus (convergent) power. Astigmatism is corrected with cylindrical lenses. Glasses have been used for centuries and are simple, relatively inexpensive, and safe. Contact lenses are an option for those who find glasses unacceptable. Problems with contacts, such as intolerance, infection, inconvenience, and cost, limit their use in some people. Lasers have been used in medicine and surgery for decades. One of the most important advances in refractive surgery is the excimer laser. In 1995, the FDA approved the first excimer laser to treat mild and moderate myopia. Since then, additional lasers have been approved for an expanded therapeutic range. The excimer laser combines argon (Ar) and fluoride (F) gases to generate a beam of ultraviolet light with a 193-nm wavelength. This has sufficient energy to break molecular bonds within corneal collagen in a process called ablative photodecomposition, or photoablation. The laser removes microscopic amounts of corneal tissue with little risk of thermal damage to surrounding tissues. A computer programmed with the patient's prescription controls the laser beam to reshape the cornea with great precision. In myopia, the laser flattens the central cornea to decrease its focusing power. In hyperopia, the laser indirectly steepens the central cornea by flattening the periphery. Astigmatism is treated with an elliptical or cylindrical beam to flatten the steepest corneal meridian. Laser-assisted in situ keratomileusis (LASIK) is an effective treatment for myopia and hyperopia. After topical anesthesia and lid preparation similar to PRK, the surgeon uses an instrument called a microkeratome to create a hinged corneal flap 8.5 to 9.5 mm in diameter with a thickness of 130 to 180 mm (average 160 mm). The flap is folded back to expose the underlying tissue to the laser. After ablation the surgeon returns the flap to its original position and irrigates under the flap with saline solution. The flap seals without the need for sutures. Topical antibiotic, an NSAID, and steroid drops are applied, and the eyelid speculum and drapes are carefully removed. The flap is inspected by slit-lamp examination to confirm good position and stability before the patient leaves the office. Visual results are comparable with PRK. Advantages of LASIK include quicker postoperative visual recovery with less discomfort and lower risk of corneal haze. A disadvantage is the potential for corneal flap complications. Although such complications may result in the loss of vision, they are, fortunately, rare (less than 0.1% of surgeries). Of interest, in a randomized prospective study of laser in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK) for myopia, Hersh et al (1998) reported that 29.4% of PRK patients and 27.1% of LASIK patients had refractive corrections within 0.5 diopters of attempted correction at six months after surgery. In comparison, Waring (1990) found that Refractive Surgery Jan 15 7

8 over 99% of patients who are corrected with glasses or contact lenses achieve refractive corrections within 0.5 diopters of normal vision. Although the safety of refractive surgical procedures is improving, these procedures are associated with significant risks of degradation of best corrected visual acuity, as well as glare, induced regular or irregular astigmatism, regression of effect, visual aberrations (including transient or permanent glare or starburst/halo effect), and decreased contrast sensitivity. These optical complications and their incidence are discussed in a 1997 American Academy of Ophthalmology (AAO) Preferred Practice Pattern on Refractive Errors and a 1999 AAO Ophthalmic Procedures Assessment on PRK. According to the former, "spectacles are the simplest and safest means of correcting a refractive error." Laser epithelial keratomileusis (LASEK) is a modification of the PRK technique that may address the shortcomings of LASIK and PRK. In LASEK, a 20% alcohol solution is applied for 25 to 35 seconds to separate the epithelium from Bowman's membrane. The loosened epithelium is retained as an intact flap that is returned to position after the laser ablation is complete. The early postoperative course is similar to PRK. LASEK may result in less corneal haze than PRK and offers an alternative for patients with high myopia who are unable or unwilling to undergo LASIK. This typically includes patients with thin corneas and patients at increased risk of flap trauma, such as athletes in contact sports and military personnel. Excimer laser photorefractive keratectomy (PRK) is approved for myopia and hyperopia. The desired correction is programmed into the laser's computer, and the patient is given topical anesthetic drops (0.5% proparacaine [Alcaine]). The eyelids are swabbed with 1% povidone iodine solution and draped with adhesive plastic drapes. A speculum gently retracts the eyelids. The corneal epithelium is removed using a soft-bristled rotary brush, the laser, or an instrument that resembles a spatula. The patient views a fixation target while the surgeon aligns the laser and delivers the laser treatment. Immediately after treatment the cornea is irrigated with chilled saline, and a contact lens is placed to protect the cornea. After surgery, the patient uses topical nonsteroidal anti-inflammatory drugs (NSAIDs) for 48 hours, antibiotic drops for 1 week, steroid drops for 1 month, and oral analgesics as needed. For the first few days, patients experience blurred vision and moderate discomfort as the corneal surface heals. The contact lens is removed after the epithelium has healed, usually in 3 to 5 days. Mild blurriness is common for several weeks as the cornea heals. Once the healing process is complete, 96% of treated eyes are 20/40 or better sufficient to drive legally without corrective lenses. Two thirds have unaided vision of 20/20 or better. Potential problems include over- or undercorrection, astigmatism, scarring, glare, and corneal haze. The latter is more common after treating higher degrees of myopia. Photorefractive keratectomy (PRK) is approved as a refractive surgical procedure involving the reshaping of the surface of the cornea with an excimer laser to correct mild-to-moderate myopia. Photoastigmatic keratectomy (PARK or PRK-A) is a refractive surgical procedure to correct myopia with astigmatism. These procedures are considered not medically necessary for patients with hyperopia of up to 6.0 diopters and myopia of up to diopters, with or without astigmatism up to 4.0 diopters, because the refractive corrections achieved with PRK and PARK are less precise than that achieved by eyeglasses or contact lenses. In 1999, the AAO Ophthalmic Procedures Assessment on PRK and PARK concluded that it: "Appears to be safe and effective procedure for the treatment of low to moderate degrees of myopia and astigmatism. Results for high degrees of myopia are associated with poorer outcomes, that is, longer stabilization periods, greater need for retreatment, and increased loss of lines of BSCVA (best spectacle corrected visual acuity)." Refractive Surgery Jan 15 8

9 Epikeratoplasty (or epikeratophakia) is a refractive surgical procedure that involves placement of a pre-carved donor corneal lens on the surface of a patient's eye. Epikeratophakia may be medically necessary for the treatment of childhood aphakia since contact lenses are difficult for children to use and intraocular lens implants may result in long-term complications in children. This procedure may also be used on scarred corneas and corneas affected with endothelial dystrophy. In addition, although secondary implantation of an intraocular lens is the favored treatment of adult aphakia, there are circumstances where reentering the eye could affect 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 is considered investigational for correction of refractive errors and for all other cases of adult aphakia. The 1997 AAO Preferred Practice Pattern on Refractive Errors states that "[t]he results have been widely variable, and there have been significant complications. This procedure is not recommended for correction of myopic refractive errors, except in very unusual circumstances." This reaffirmed the 1995 AAO Ophthalmic Procedure Assessment of epikeratophakia. Intrastromal corneal ring segments (INTACS) (Addition Technology, Sunnyvale, CA) have been approved by the FDA for adults with mild myopia (from -1.0 to -3.0 diopters) that have less than 1 diopter of astigmatism. Intrastromal corneal ring segments are considered not medically necessary for patients with mild myopia, and are considered experimental and investigational for children, for patients with moderate to severe myopia (greater than -3.0 diopters), for patients with more than 1 diopter of astigmatism, and for hyperopia. As the FDA has determined that INTACS are medical devices intended to treat a condition that affects fewer than 4000 individuals per year in the United States, they are considered medically necessary for reduction or elimination of myopia or astigmatism in persons with keratoconus who are no longer able to achieve adequate vision using contact lenses or spectacles, so that their functional vision may be restored and the need for corneal transplant procedure may potentially be postponed. According to the FDA, the specific subset of keratoconic patients proposed to be treated with INTACS prescription inserts are those who: 1) have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles; 2) who are 21 years of age or older; 3) who have clear central corneas; 4) who have a 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 (FDA, 2004). INTACS involves inserting a flexible ring beneath the surface of the cornea to elevate the edge the cornea. This effectively flattens the front of the eye, decreasing nearsightedness. Different size rings are used to correct different amounts of nearsightedness. Boxer Wachler, et al. (2003) reported on a retrospective study of 74 eyes of 50 persons who received INTACS implantation. The investigators found that the mean improvement in uncorrected visual acuity in persons with keratoconus who received INTACS was four lines of uncorrected visual acuity and two lines of best corrected visual acuity. The investigators also reported decreases in irregular astigmatism. In a prospective study involving 10 patients with keratoconus, Colin, et al. (2000) reported a 70 percent improvement in uncorrected visual acuity and a 50 percent improvement in best corrected visual acuity. Radial keratotomy (RK) involves the use of radial incisions in the cornea to correct mild to moderate myopia. Radial keratotomy is not considered medically necessary for treatment of myopia ranging from to diopters because this refractive error can be corrected satisfactorily with eyeglasses or contact lenses. Radial keratotomy is considered Refractive Surgery Jan 15 9

10 investigational for treatment of myopia greater than diopters and it is also considered investigational for treatment of all other refractive errors. The established indications for radial keratotomy were based on the 1992 AAO Ophthalmic Procedures Assessment of Radial Keratotomy for Myopia. The AAO's position on RK was reaffirmed in the 1997 AAO Preferred Practice Pattern on Refractive Errors, which restated that RK is indicated for "low to moderate myopia." Astigmatic keratotomy (AK) (arcuate incision, corneal wedge resection) is a refractive surgical procedure similar to RK that is used to reduce astigmatism. Instead of radial incisions, a curvilinear pattern is used to smooth the areas of the cornea that are too steeply curved. In some instances, surgeons have combined RK with AK in patients with myopia with astigmatism. Variations of astigmatic keratotomy include the Ruiz Procedure and the Troutman Wedge Resection. Astigmatic keratotomy may be covered when performed for the correction of surgically induced astigmatism following medically indicated cataract removal or corneal transplant surgery (see criteria above). Astigmatic keratotomy is considered investigational for treatment of all other refractive errors. The 1997 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." Standard keratomileusis (ALK) where the cornea is shaped with a microkeratome rather than with a laser, is considered investigational for treatment of all refractive errors. The 1997 AAO Preferred Practice Pattern on Refractive Errors states "In its 1995 assessment on ALK, the AAO identified a lack of peer-reviewed literature, although there are a number of studies ongoing. In current clinical practice, ALK is being replaced by laser in situ keratomileusis." Keratophakia involves implantation of a donor cornea within the corneal stroma to modify its refractive power. Keratophakia is considered investigational for correction of refractive errors. Keratophakia was not addressed in the 1997 AAO Preferred Practice Pattern on Refractive Errors. However, an August 1992 AAO Ophthalmic Procedure Assessment of keratophakia concluded that they found only a "handful of reports" in peer-reviewed medical journals regarding keratophakia for correction of refractive errors, and few "well controlled studies." The AAO assessment raised questions about the safety and effectiveness of keratophakia. Since publication of the AAO's assessment, no additional clinical studies of keratophakia for refractive errors have been published, so the questions raised by that assessment remain unanswered. Lamellar keratoplasty (non-penetrating keratoplasty) is a corneal transplant procedure in which a partial thickness of the cornea is removed and the diseased tissue is replaced with a partial-thickness donor cornea. The donor eye is prepared by making a partial thickness trephine incision in the cornea and dissecting free the lamellar button. This procedure may be indicated for a number of corneal diseases, including scarring, edema, thinning, distortion, dystrophies, degenerations, and keratoconus. It is considered investigational and not medically necessary when performed solely to correct astigmatism and other refractive errors. Penetrating keratoplasty (PK) (corneal transplantation, perforating keratoplasty) is a corneal transplant procedure involving replacement of the full thickness of the cornea with donor cornea, but retaining the peripheral cornea. As with lamellar keratoplasty, this procedure may be indicated for a number of corneal diseases. Most PKs are performed to improve poor visual acuity caused by an opaque cornea. Penetrating keratoplasty has also been used to remove active corneal disease, such as persistent severe bacterial, fungal, or amebic Refractive Surgery Jan 15 10

11 inflammation of the cornea (keratitis) after appropriate antibiotic therapy. Penetrating keratoplasty has also been performed to restore altered corneal structure or to prevent loss of the globe that has been punctured. The most common indications for PK are bullous keratopathy, keratoconus, corneal scar with opacity, keratitis, corneal transplant rejection, Fuch's dystrophy, corneal degeneration, other corneal dystrophies, corneal edema, and herpes simplex keratitis. Penetrating keratoplasty is considered investigational and not medically necessary when performed solely to correct astigmatism or other refractive errors. Conductive keratoplasty involves the application of radiofrequency thermal energy to increase the curvature of the cornea and thereby reduce hyperopia. Conductive keratoplasty using the ViewPoint CK System (Refractec Inc., Irvine, CA) has been approved by the FDA for treatment of patients who are at least 40 years of age, who have mild to moderate hyperopia (0.75 D to 3.25 D), who have 0.75 D or less astigmatism, and whose eyesight has changed very little over the previous 12 months (as demonstrated by a change of less than 0.50 D in refraction). Conductive keratoplasty is considered not medically necessary for its FDA-approved indications, and is considered investigational for all other indications. According to the FDA, conductive keratoplasty temporarily improves distance vision in farsighted people. Although some patients may retain some or all of the correction achieved during surgery, for most people the amount of farsightedness correction is temporary and will decrease over time. Vision without glasses is improved after conductive keratoplasty, but some people still need glasses or contact lenses. Since it corrects only farsightedness, CKSM does not eliminate the need for reading glasses. Conductive keratoplasty is considered to be investigational as a treatment of keratoconus. Methods of thermokeratoplasty other than conductive keratoplasty, such as the superficial treatment of Gassett and Kaufman for keratoconus, holmium:yag laser thermokeratoplasty (laser thermokeratoplasty or LTK), or the hot needle of Fyodorov, are considered ineffective and are considered investigational for treatment of refractive errors or keratoconus. These methods of thermokeratoplasty have been abandoned because the corneal wound healing response produced postoperative scarring and instability (Waring, 1995). Orthokeratology involves the application of sequentially flatter hard contact lenses to flatten the cornea and thereby reduce myopic refractive error. It, too, is considered investigational. The AAO Preferred Practice Pattern on Refractive Errors states that "attempts to predict which patients will respond to orthokeratology based on ocular biomechanical or biometric parameters have not been successful. The effects of orthokeratology have been unpredictable and poorly controlled. This approach is not recommended." Scleral expansion surgery is considered investigational for presbyopia. Scleral expansion surgery involves making small incisions in the eye and inserting bands to stretch the part of the sclera that lies beneath the ciliary muscles that control accommodation (NICE, 2004). This procedure is claimed to improve accommodation. An assessment of scleral expansion surgery by the National Institute for Clinical Excellence (2004) recommended that "this procedure should not be used." Based on an assessment of available published evidence, the assessment concluded that "current evidence on the safety and efficacy of scleral expansion surgery for presbyopia is very limited and that all studies identified were of poor quality." The assessment explained that "there is no evidence of efficacy in the majority of patients" and that "there are also concerns about the potential risks of the procedure." Intraocular lens implants (clear lens extraction) (aphakic intraocular lenses (IOLs)) are considered not medically necessary for correction of presbyopia, hyperopia, and myopia because these refractive errors can be corrected satisfactorily with eyeglasses or contact Refractive Surgery Jan 15 11

12 lenses. Clear lens extraction is similar to cataract removal surgery in that the natural lens is removed and replaced with an intraocular lens. Implantable contact lenses (without lens extraction) (phakic intraocular lenses [IOLs]) (e.g., Artisan lens, Verisye lens) has been approved by the FDA for adult patients who have myopia ranging from -5 to -20 diopters with less than or equal to 2.5 diopter of astigmatism. Implantable contact lenses are considered not medically necessary for myopia ranging from -5 to -20 diopters in persons with 2.5 diopters of astigmatism or less because external contact lenses or eyeglasses produce equivalent therapeutic results for treatment of refractive errors. Implantable contact lenses are considered investigational for other indications. Keratoprosthesis (artificial cornea) is still considered investigational. In some patients who cannot undergo the standard penetrating keratoplasty using donor tissue for several reasons (e.g., disease severity, severe involvement of the conjunctiva, objection to the use of donor tissue, failed past donor tissue transplants, or when measures required to prevent graft rejection are medically contraindicated), penetrating keratoplasty using a keratoprosthesis has been employed as an alternative. However, the clinical value of this prosthesis has not been established. The Alberta Heritage Foundation for Medical Research (AHFMR, 2001) noted that there is inadequate evidence to prove the safety and effectiveness of any keratoprosthesis model, and as keratoprosthesis models keep evolving, these new versions have not yet been proven in human trials with sufficient follow-up and patient numbers. The AHFMR further stated that: "currently there is no consensus in the literature on optimal device and implantation techniques, and no accepted standard for this procedure. In general, keratoprosthesis surgery is complicated, has a narrow safety margin, and requires intensive follow-up, thus a conservative approach is currently recommended by the eye specialists in this area". Furthermore, Alio and colleagues (2004) reported that corneal keratoprosthesis (BIOKOP I, II) did not provide a stable anatomical relation with the surrounding ocular structures. Its ability to restore vision is limited to a short post-operative period in eyes implanted with severe ocular surface disease. Additionally, the National Institute of Clinical Excellence (Dillon, 2004) stated that current evidence on the safety and efficacy of insertion of hydrogel keratoprosthesis does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research. Review History November 2007 March 2011 January 2012 April 2012 January 2013 January 2014 January 2015 Medical Advisory Council initial approval Update. Added Link to Medicare NCD Update. No Revisions. Removed INTACS for the not medically necessary treatment of keratoconus without mild myopia. This is discussed in the INTACS policy. Update no revisions. Added updated codes. Update no revisions. Added updated codes. Update no revisions. Codes updated. This policy is based on the following evidence-based guidelines: 1. American Academy of Ophthalmology Refractive Errors Panel. Refractive errors. San Francisco (CA): American Academy of Ophthalmology; Refractive Surgery Jan 15 12

13 2. American Optometric Association. Care of the patient with hyperopia. St. Louis (MO): American Optometric Association; American Optometric Association. Care of the patient with myopia. St. Louis (MO): American Optometric Association; American Optometric Association. Care of the patient with presbyopia. 2nd ed. St. Louis (MO): American Optometric Association; National Institute for Clinical Excellence (NICE). Laser in situ keratomileusis for the treatment of refractive errors. Interventional Procedure Guidance 102. London, UK: NICE; December National Institute for Clinical Excellence (NICE). Scleral expansion surgery for presbyopia. Interventional Procedure Guidance No. 70. London, UK: NICE; July Conseil de Evaluation des Technologies de la Sante (CETS). The excimer laser in ophthalmology: A state-of-knowledge update. Montreal, QC: CETS; National Institute for Clinical Excellence (NICE). Laser in situ keratomileusis for the treatment of refractive errors. Interventional Procedure Guidance 102. London, UK: NICE; December National Institute for Clinical Excellence (NICE). Insertion of hydrogel keratoprosthesis. Interventional Procedure Guidance 69. London, UK: NICE; June References Update January Barsam A, Allan BD. Excimer laser refractive surgery versus phakic intraocular lenses for the correction of moderate to high myopia. Cochrane Database Syst Rev O'Brart DP, Shalchi Z, McDonald RJ, et al. Twenty-year follow-up of a randomized prospective clinical trial of excimer laser photorefractive keratectomy. Am J Ophthalmol 2014; 158: Tsuneyoshi Y, Negishi K, Saiki M, et al. Apparent progression of presbyopia after laser in situ keratomileusis in patients with early presbyopia. Am J Ophthalmol 2014; 158:286. References Update January America Academy of Ophthalmology. (AAO). Refractive Surgery 2013: Perfecting Vision. Sponsored by the International Society of Refractive Surgery (ISRS). The Annual Meeting of ISRS. 2. Okada M, Hersh D, Paul E, et al. Effect of Centration and Circularity of Manual Capsulorrhexis on Cataract Surgery Refractive Outcomes. Ophthalmology Dec 14. pii: S (13) doi: /j.ophtha [Epub ahead of print] References Update January Auerbach: Wilderness Medicine, 6th ed The Eye at Altitude Mosby, An Imprint of Elsevier. 2. Bower KS. Laser refractive surgery. UpToDate. October 25, 2012.Updated September 23, Kohnen T. Evaluation and quality assurance of refractive surgery procedures by the German Ophthalmological Society and the Professional Association of German Ophthalmologists. Ophthalmologe. 01-SEP-2011; 108(9): References Update January No authors listed. Functional results of contact lens correction and penetrating keratoplasty in keratoconus. Report 2. Wavefront analysis. Vestn Oftalmol Shtein RM. Post-LASIK dry eye. Expert Rev Ophthalmol Oct;6(5): Refractive Surgery Jan 15 13

14 3. Singh D, Pushker N, Bajaj MS, et al. Visual function alterations in orbital tumors and factors predicting visual outcome after surgery. Eye (Lond) Dec 9. doi: /eye [Epub ahead of print] References Initial 1. Finlay AL. Binocular vision and refractive surgery. Cont Lens Anterior Eye May;30(2): Du TT, Fan VC, Asbell PA. Conductive keratoplasty. Curr Opin Ophthalmol Jul;18(4): Ertan A, Colin J. Intracorneal rings for keratoconus and keratectasia. J Cataract Refract Surg Jul;33(7): Tudosie M, Burcea M, Tataru C, Celea C. How to select patients for excimer laser refractive surgery. Oftalmologia. 2007;51(1): Tudosie M, Burcea M, Tataru C, Celea C. Complication of excimer laser refractive surgery. Oftalmologia. 2007;51(1): Cochener B. Refractive surgery: a solution for elimination of glasses? Rev Prat Jun 15;56(11): Shortt AJ, Bunce C, Allan BD. Evidence for superior efficacy and safety of LASIK over photorefractive keratectomy for correction of myopia. Ophthalmology Nov;113(11): Ayres BD, Rapuano CJ. Excimer laser phototherapeutic keratectomy. Ocul Surf Oct;4(4): Hladun L, Harris M. Contact lens fitting over intrastromal corneal rings in a keratoconic patient. Optometry. 2004;75(1): Hofling-Lima AL, Branco BC, Romano AC, et al. Corneal infections after implantation of intracorneal ring segments. Cornea. 2004;23(6): Alio JL, Artola A, Ruiz-Moreno JM, et al. Changes in keratoconic corneas after intracorneal ring segment explantation and reimplantation. Ophthalmology. 2004;111(4): Alio JL, Mulet ME, Haroun H, et al. Five year follow up of biocolonisable microporous fluorocarbon haptic (BIOKOP) keratoprosthesis implantation in patients with high risk of corneal graft failure. Br J Ophthalmol. 2004;88(12): Boxer Wachler BS, Christie JP, Chandra NS, et al. Intacs for keratoconus. Ophthalmology. 2003;110(5): Colin J, Velou S. Current surgical options for keratoconus. J Cataract Refract Surg. 2003;29(2): Colin J, Velou S. Implantation of Intacs and a refractive intraocular lens to correct keratoconus. J Cataract Refract Surg. 2003;29(4): Siganos CS, Kymionis GD, Kartakis N, et al. Management of keratoconus with Intacs. Am J Ophthalmol.2003;135(1): McDonald MB, Davidorf J, Maloney RK, et al. Conductive keratoplasty for the correction of low to moderate hyperopia: 1-year results on the first 54 eyes. Ophthalmology. 2002;109(4): 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. Ophthalmology. 2002;109(1): Qazi MA, Pepose JS, Shuster JJ. Implantation of scleral expansion band segments for the treatment of presbyopia. Am J Ophthalmol. 2002;134: Dick HB, Gross S, Tehrani M, et al. Refractive lens exchange with an array mutifocal intraocular lens. J Refract Surg. 2002;18(5): Jacobi PC, Dietlein TS, Luke C, Jacobi FK. Multifocal intraocular lens implantation in presbyopic patients with unilateral cataract. Ophthalmology. 2002:109(4): Refractive Surgery Jan 15 14

15 22. Colin J, Velou S. Utilization of refractive surgery technology in keratoconus and corneal transplants. Curr Opin Ophthalmol. 2002;13(4): Rapuano CJ, Sugar A, Koch DD, et al and the Ophthalmic Technology Assessment Committee Refractive Surgery Panel. Intrastromal corneal ring segments for low myopia: A report by the American Academy of Ophthalmology. Ophthalmology. 2001;108(10): Schanzlin DJ, Abbott RL, Asbell PA, et al. Two-year outcomes of intrastromal corneal ring segments for the correction of myopia. Ophthalmology. 2001;108(9): Asbell PA, Maloney RK, Davidorf J, et al. Conductive keratoplasty for the correction of hyperopia. Trans Am Ophthalmol Soc. 2001;99: Malecaze FJ, Gazagne CS, Tarroux MC, Gorrand JM. Scleral expansion bands for presbyopia. Ophthalmology. 2001;108: Vetrugno M, Cardia L. Spontaneous extrusion of a scleral expansion band segment. Ann Ophthalmol. 2001;33: Packer M, Fine IH, Hoffman RS. Refractive lens exchange with the array multifocal intraocular lens. J Cataract Refract Surg. 2001;28(3): Colin J, Cochener B, Savary G, et al. INTACS inserts for treating keratoconus: One-year results. Ophthalmology. 2001;108(8): Colin J, Cochener B, Savary G, et al. Correcting keratoconus with intracorneal rings. J Cataract Refract Surg. 2000;26(8): Singh G. Chalfin S. A complication of scleral expansion surgery for treatment of presbyopia. Am J Ophthal. 2000;130: Colin J, Cochener B, Savary G, Malet F. Correcting keratoconus with intracorneal rings. J Cataract Refract Surg. 2000;26(8): No authors listed. Excimer laser photorefractive keratectomy (PRK) for myopia and astigmatism. American Academy of Ophthalmology. Ophthalmology. 1999;106(2): Mathews S. Scleral expansion surgery does not restore accommodhuman presbyopia. Ophthalmology. 1999;106: American Academy of Ophthalmology. Refractive errors. Preferred Practice Pattern. San Francisco, CA: AAO; No authors listed. Automated lamellar keratoplasty.. American Academy of Ophthalmology. Ophthalmology. 1996;103(5): No authors listed. Epikeratoplasty. Ophthalmology. 1996;103(6): Tutton MK, Cherry PM. Holmium:YAG laser thermokeratoplasty to correct hyperopia: Two years follow-up. Ophthalmic Surg Lasers. 1996;27(5 Suppl):S521-S Waring GO. The challenge of corneal wound healing after excimer laser refractive corneal surgery. J Refract Surg. 1995;11(5). Available at: Charpentier DY, Nguyen-Khoa JL, Duplessix M, et al. Radial thermokeratoplasty is inadequate for overcorrection following radial keratotomy. J Refract Corneal Surg. 1994;10(1): No authors listed. Radial keratotomy for myopia. American Academy of Ophthalmology. Ophthalmology. 1993;100(7): No authors listed. Keratophakia and keratomileusis: Safety and effectiveness. American Academy of Ophthalmology. Ophthalmology. 1992;99(8): American Academy of Ophthalmology. Low to moderate refractive errors. Preferred Practice Pattern. San Francisco, CA: American Academy of Ophthalmology; Neumann AC, Sanders D, Raanan M, DeLuca M. Hyperopic thermokeratoplasty: Clinical evaluation. J Cataract Refract Surg. 1991;17(6): 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. JAMA. 1990;263(8): Refractive Surgery Jan 15 15

16 46. Feldman ST, Ellis W, Frucht-Pery J, et al. Regression of effect following radial thermokeratoplasty in humans. Refract Corneal Surg. 1989;5(5): Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peerreviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Refractive Surgery Jan 15 16

17 Reconstructive Surgery CA Health and Safety Code requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Refractive Surgery Jan 15 17