Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Clinical Policy Title: Therapeutic contact lenses Clinical policy number: 10.02.01 Effective Date: Initial Review Date: Most Recent Review Date: Next Review Date: June 1, 2014 December 18, 2013 January 21, 2015 January 2016 Policy contains: Hydrophilic Contact Lens For Corneal Bandage. Boston scleral lens. Scleral shell lens. Amniotic membrane lens (ProKera). RELATED POLICIES: None ABOUT THIS POLICY: Keystone First has developed clinical policies to assist with making coverage determinations. Keystone First clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by Keystone First when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Keystone First clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Keystone First clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Keystone First will update its clinical policies as necessary. Keystone First clinical policies are not guarantees of payment. Coverage Policy Keystone First considers the use of therapeutic contact lenses to be clinically proven and, therefore, medically necessary when the following criteria are met: 1. Type of covered lens: a. Contact lenses or intra-ocular lenses placed after cataract surgery are considered prostheses and are a covered benefit unless otherwise specified by the member’s Benefit Plan; b. Hydrophilic soft contact lenses or gas-permeable fluid ventilated scleral lenses are medically necessary prostheses when used in the management of severe corneal disease; c. Boston Scleral Lens are a medically necessary prosthesis when used as a moist corneal bandage if lubricants or drops are not appropriate; OR d. Scleral shell contact lenses are medically necessary for the treatment of severe keratoconjunctivitis sicca and/or when the orbit requires greater support because of the loss of corneal strength. —AND— 2. Functional impairment being corrected: 1 a. Not able to achieve vision of 20/40 or better despite best correction with eyeglasses or typical contact lenses; b. Lenses will delay/prevent the need or corneal transplantation; OR c. Will improve performance of activities of daily living Limitations: All other uses of therapeutic contact lenses are not medically necessary. Contact lenses for vision correction are subject to benefit plans of the individual member. The use of contact lenses for treatment of visual perceptual dysfunction, such as dyslexia, has not had consistent results in clinical studies so cannot be considered a medically necessary treatment. Amniotic membrane transplantation has insufficient evidence in the peer-reviewed medical literature to support its use over standard care. Alternative Covered Services: Physician office visits. Standard covered ocular surgery. Standard medical management of corneal disease. Background Corneal pathology may cause correctable vision distortion, pain, or threaten sight. Vision may be corrected by the use of refractive eyeglasses or contact lenses. These lenses are primarily used for correction of myopia, hypermetropia, astigmatism, and presbyopia. In such situations, the use of contact lenses is as a cosmetic substitute for eyeglasses. Refracting contact lenses may be rigid/hard lens, soft (hydrophilic, hydrogel and silicone hydrogel), or gas permeable rigid lens. Therapeutic contact lenses are designed to manage other ocular pathology beyond simple refractive disorders. The corneal disorders for which contact lenses become therapeutic include such conditions as: Aphakia; Prostheses following cataract surgery; Stevens-Johnson syndrome, Toxic Epidermolysis Necrosis (TEN), chemical burns or other corneal stem cell deficiencies; Congenital anomalies; Neurotrophic corneas; Keratoconjunctivitis with reduced tear production; Corneal involvement of systemic autoimmune disorders; Corneal exposure disorders; Epidermal ocular disorders; and Keratoconus associated with irregular astigmatism. There are several types of therapeutic lenses available for the management of these disorders. The use of the various the lens options have not been standardized through randomized controlled trials; but there is a general standard now accepted for the use: 2 1. Corneal liquid bandage lens—These may be rigid gas-permeable scleral contact lenses (RGP-ScCL) or a therapeutic contact lens (TSCLs). These are used to treat acute or chronic corneal disease such as persistent epithelial defects as listed above. These lenses protect the cornea from drying effects of air and may reduce pain and photophobia. Because such lenses cover the entire cornea with a smooth surface they may improve vision that results from acute astigmatism. 2. Boston scleral lens (BSL)—This lens was developed through the Boston Foundation for Sight. It is a specially designed fluid-ventilated, gas-permeable contact lens. The design allows a bubble-free reservoir of oxygenated aqueous fluid to cover the corneal surface at a neutral hydrostatic pressure. This design makes it well suited for severe corneal disease. 3. Scleral shell contact lens—unlike other types of lens, the scleral shell contact covers the entire exposed surface of the eye. For individuals with severe dry eye such as keratoconjunctivitis, the scleral shell lens can hold artificial tears that have been dropped into the eye. These lenses protect the eye against further drying. The supporting nature of the scleral shell also allows support and protection when severe corneal disease has rendered the person blind. Use of the scleral shell may prevent enucleation by providing support for the rest of the eye. 4. Amniotic membrane transplant—rather than provide a contact lens in cases of severe thermal or chemical burns to the cornea, there are a few trials using amniotic members that may be transplanted to the area of burn to reduce pain and to accelerate healing. Review of such studies by Cochrane and Hayes have not found sufficient evidence to warrant use as there is insufficient data from published peer-reviewed articles to support its use (Clare 2012, Hayes 2013). Methods Searches: Keystone First searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality’s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services. Searches were conducted on December 8, 2013-December 10, 2013 using the terms “therapeutic contact lenses” and “amniotic membrane”. Included were: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidencegrading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes — sometimes referred to as efficiency studies — which also rank near the top of evidence hierarchies. 3 Findings Most studies on the various medical uses of contact lenses have been single-site with relatively small numbers enrolled. There were no recent meta-analyses found of therapeutic contact lenses or of head to head comparisons between the various products. Professional guidelines from the American Academy of Ophthalmology note the absence of such studies and make recommendations that the professional engages with the patient describing the advantages of various strategies, allowing the patient to be an active participant in the clinical judgment. There is consensus that patients with corneal pathology that threatens to weaken the architecture of the eye should be treated with appropriate medical therapy and/or supporting contact lenses. Summary of Clinical Evidence Citation Content, Methods, Recommendations Watson 2012 Key Points This was a meta-analysis that found only 7 randomized and 1 quasi-randomized trial on the management of recurrent corneal erosion. .These various studies came to different independent conclusions as to management of recurrent corneal erosions using oral tetracycline, contact lenses, or hypertonic saline ointment. The therapeutic contact lens arm had older rigid lenses. The therapeutic contact lens arm was less able to reduce pain or promote healing compared to the oral tetracycline or hypertonic saline ointment. Hayes 2013 Key Point This is a meta-analysis of the literature around Boston Equalens scleral contact lens. There were only four uncontrolled studies, where the endpoints were not clear. .The descriptions from the four studies were consistent with significant relief of pain, reduced photophobia and improved visual acuity. Clare 2012 Key Point Cochrane review This is a review from Cochrane Eyes and Vision Group Trials that found one RCT with 100 participants with ocular burns provided either standard treatment or amniotic membrane transplant. The study was flawed in that the control group had worse acuity at the start than did the amniotic membrane transplant group. But the latter had better vision at the end. The conclusion is that there is inadequate evidence supporting the treatment of ocular surface burns with amniotic membrane transplant. 4 POLICY UPDATE January 2015 Findings Searches were updated on January 4, 2015. No new systematic reviews, evidence-based guidelines or economic studies were found. Since the last review date of this policy, one clinical trial (ClinicalTrials.gov Identifier: NCT01699750) has completed with published results (Maissa 2014), but these results would not impact this clinical policy. Therefore, no changes to the policy are warranted. Other clinical policies CMS National Coverage Determination (NCD) for Hydrophilic Contact Lens For CORNEAL Bandage (80.1) Policy Benefit Category Incident to a physician's professional Service Outpatient Hospital Services Incident to a Physician's Service Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service. Item/Service Description Some hydrophilic contact lenses are used as moist corneal bandages for the treatment of acute or chronic corneal pathology, such as bullous keratopathy, dry eyes, corneal ulcers and erosion, keratitis, corneal edema, descemetocele, corneal ectasis, Mooren's ulcer, anterior corneal dystrophy, neurotrophic keratoconjunctivitis, and for other therapeutic reasons. Indications and Limitations of Coverage Payment may be made under §1861(s)(2) of the Act for a hydrophilic contact lens approved by the Food and Drug Administration (FDA) and used as a supply incident to a physician's service. Payment for the lens is included in the payment for the physician's service to which the lens is incident. Contractors are authorized to accept an FDA letter of approval or other FDA published material as evidence of FDA approval. (See §80.4 of the NCD Manual for coverage of a hydrophilic contact lens as a prosthetic device.) National Coverage Determination (NCD) for Hydrophilic Contact Lenses (80.4) Benefit Category Prosthetic Devices Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service. Indications and Limitations of Coverage Hydrophilic contact lenses are eyeglasses within the meaning of the exclusion in §1862(a)(7) of the Act and are not covered when used in the treatment of nondiseased eyes with spherical ametrophia, refractive astigmatism, and/or corneal astigmatism. Payment may be made under the prosthetic device benefit, however, for hydrophilic contact lenses when prescribed for an aphakic patient. Contractors are authorized to accept an FDA letter of approval or other FDA published material as evidence of FDA approval. (See §80.1 of the NCD Manual for coverage of a hydrophilic lens as a corneal bandage.) 5 CMS National Coverage Determination (NCD) for Scleral Shell (80.5) Policy Benefit Category Prosthetic Devices Item/Service Description Scleral shell (or shield) is a catchall term for different types of hard scleral contact lenses. Indications and Limitations of Coverage A scleral shell fits over the entire exposed surface of the eye as opposed to a corneal contact lens which covers only the central non-white area encompassing the pupil and iris. Where an eye has been rendered sightless and shrunken by inflammatory disease, a scleral shell may, among other things, obviate the need for surgical enucleation and prosthetic implant and act to support the surrounding orbital tissue. In such a case, the device serves essentially as an artificial eye. In this situation, payment may be made for a scleral shell under §1861(s)(8) of the Act. Scleral shells are occasionally used in combination with artificial tears in the treatment of "dry eye" of diverse etiology. Tears ordinarily dry at a rapid rate, and are continually replaced by the lacrimal gland. When the lacrimal gland fails, the half-life of artificial tears may be greatly prolonged by the use of the scleral contact lens as a protective barrier against the drying action of the atmosphere. Thus, the difficult and sometimes hazardous process of frequent installation of artificial tears may be avoided. The lens acts in this instance to substitute, in part, for the functioning of the diseased lacrimal gland and would be covered as a prosthetic device in the rare case when it is used in the treatment of "dry eye." Glossary Cornea — The thin transparent covering over the anterior portion of the eye. The cornea covers the iris, pupil and anterior chamber of the eye. Corneal ectasia — A non-inflammatory progressive steepening and thinning of the corneal. This may include keratoconus, pellucid marginal degeneration, keratoglobus, postkeratorefractive ectasia and wound ectasia. Keratoconjunctivitis sicca — Is also termed dry eye syndrome of xerophthalmia. The condition is caused by reduced tear production or excessive tear evaporation. Lens — The biconvex structure in the eye through which light entering the eye is focused on the retina for vision. Limbus — The border of the cornea that is continuous with the sclera. Visual perceptual dysfunctions — Is a visual distortion caused by sensitivities to particular wavelengths of light. 6 Source in public domain: http://en.wikipedia.org/wiki/File:Cornea.png Related policies: Keystone First Utilization Management program description. References Professional society guidelines/others: American Academy of Ophthalmology Cornea/External Disease Panel. Preferred Practice Pattern Guidelines. Corneal Edema and Opacification Summary Benchmarks, San Francisco, CA; American Academy of Ophthalmology; 2013. Available at: http://one.aao.org/preferred-practice-pattern/corneal-edemaopacification-ppp--2013. Accessed January 4, 2015. American Academy of Ophthalmology Cornea/External Disease Panel. Preferred Practice Pattern Guidelines. Corneal Ectasia. San Francisco, CA; American Academy of Ophthalmology; 2013. Available at: http://one.aao.org/preferred-practice-pattern/corneal-ectasia-ppp--2013. Accessed January 4, 2015. American Academy of Ophthalmology. Preferred Practice Pattern Guidelines. Dry Eye Syndrome. San Francisco, CAa; American Academy of Ophthalmology; 2013. Available at: http://one.aao.org/preferredpractice-pattern/dry-eye-syndrome-ppp--2013. Accessed January 4, 2015. American Academy of Pediatrics, Section on Ophthalmology, Council on Children with Disabilities, American Academy of Ophthalmology, American Association for Pediatric Ophthalmology and Strabismus and American Association of Certified with Disabilities, American Academy of Ophthalmology, American Orthoptists. Learning Disabilities, Dyslexia, and Vision. Pediatrics 2009 Aug;124(2); 837-44. Available at: http://pediatrics.aappublications.org/content/124/2/837.long. Accessed January 4, 2015. 7 Peer-reviewed references: Clare G, Suleman H, Bunce C, Dua H. Amniotic membrane transplantation for acute ocular burns. Cochrane Database Syst Rev. 2012 Sep 12;9:CD009379 Foulks GN, Harvey T, Raj CV. Therapeutic contact lenses: the role of high-Dk lenses. Ophthalmol Clin North Am. 2003 Sep;16(3):455-61. Hayes Inc. Hayes Medical Technology Directory Report. Boston Equalens Scleral Contact Lens (Polymer Technology Corp.) for Severe Ocular Surface Disease. Lansdale, Pa: Hayes Inc.; October, 2006. Hayes Inc. Hayes Medical Technology Directory Report. ProKera (Bio-Tissue Inc.) for the treatment of corneal ulcers, Lansdale, Pa: Hayes Inc.; January, 2013. Jacobs DS, Rosenthal P. Boston scleral lens prosthetic device for treatment of severe dry eye in chronic graft-versus-host disease. Cornea. 2007 Dec;26(10):1195-9. Maissa C, Guillon M, Cockshott N, Garofalo RJ, Lemp JM, Boclair JW. Contact lens lipid spoliation of hydrogel and silicone hydrogel lenses. Optometry and Vision Science: official publication of the American Academy of Optometry. 2014;91(9):1071-1083. Szczotka-Flynn L, Diaz M. Risk of corneal inflammatory events with silicone hydrogel and low dk hydrogel extended contact lens wear: a meta-analysis. Optom. Vis Sci. 2007 Apr;84(4):247-56. Watson SL, Lee MH, Barker NH. Interventions for recurrent corneal erosions. The Cochrane Database of Systematic Reviews. 2012;9:CD001861. Clinical Trials: Searched clinicaltrials.gov on January 4, 2015 using terms for “hydrophilic contact Lens” OR “corneal bandage” OR “boston scleral lens’” OR “scleral shell lens” or “amniotic membrane”. Nine relevant studies found. Hyper-CL™ Lens (Hyper Osmotic Contact Lens) In Subjects Suffering From Corneal Edema. http://ClinicalTrials.gov/show/NCT0189025. Surgical Result of Pterygium Extended Removal Followed by Fibrin Glue Assisted Amniotic Membrane Transplantation. http://ClinicalTrials.gov/show/NCT02015000. The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns. http://ClinicalTrials.gov/show/NCT00370812. Recurrent Pterygium Surgery With Mitomycin C Application Using Limbal Conjunctival Versus Amniotic Membrane. http://ClinicalTrials.gov/show/NCT01319721. Transplantation of Tissue Cultured Human Amniotic Epithelial Cells Onto Damaged Ocular Surfaces. http://ClinicalTrials.gov/show/NCT00344708. 8 Limbal Epithelial Stem Cell Transplantation: a Phase II Multicenter Trial. http://ClinicalTrials.gov/show/NCT02318485. Transplantation of Cultivated Corneal Epithelial Sheet in Patients With Ocular Surface Disease. http://ClinicalTrials.gov/show/NCT01123044. Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery. http://ClinicalTrials.gov/show/NCT01249235. A Comparison Between Bandage Contact Lens, Punctal Plugs and Standard Measures in Preventing Corneal Injuries. http://ClinicalTrials.gov/show/NCT01961193. Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems, ClinicalTrials.gov Identifier: NCT01699750 The purpose of this study is to evaluate the lipid uptake, wetting characteristics, and visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses when used in conjunction with two contact lens care systems, OPTI-FREE® PUREMOIST® MPDS and BIOTRUE®. This study has completed. See Maissa (2014). Centers for Medicare and Medicaid Services (CMS) National Coverage Determination National Coverage Determination (NCD) for Hydrophilic Contact Lens for Corneal Bandage (80.1): http://cms.hhs.gov/medicare-coverage-database/details/ncddetails.aspx?NCDId=136&ncdver=1&DocID=80.1&bc=gAAAAAgAAAAAAA%3d%3d&. Accessed January 4, 2015. National Coverage Determination (NCD) for Scleral Shell (80.5): http://www.cms.gov/medicare-coveragedatabase/details/ncd-details.aspx?NCDId=235&ncdver=1&bc=AAAAQAAAAAAA&. Accessed January 4, 2015. National Coverage Determination (NCD) for Refractive Keratoplasty (80.7): http://cms.hhs.gov/medicarecoverage-database/details/ncddetails.aspx?NCDId=72&ncdver=1&DocID=80.7&kq=true&kq=true&bc=gAAAAAgAAAAAAA%3d%3d&. Accessed January 4, 2015. Local Coverage Determinations None at this time. Commonly Submitted Codes: Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill in accordance with those manuals. CPT Code 92071 Description Fitting of contact lens for treatment of ocular surface disease Comment Key Code 9 92072 Fitting of contact lens for management of keratoconus; initial fitting 92311 Prescription of optical and physical characteristics of and fitting of contact lens, with medical supervision of adaptation, corneal lens, both eyes, except for aphakia …corneal lens for aphakia, 1 eye 92312 …corneal lens for aphakia, both eyes 92314 …corneoscleral lens 92310 Key Code Key Code Key Code ICD-9 Code /Description Comment 695.10: Erythema multiforme, unspecified 696.11: Erythema multiforme minor 695.12: Erythema multiforme major 695.13: Stevens-Johnson syndrome 695.14: Stevens-Johnson syndrome-toxic epidermal necrolysis overlap syndrome 695.15:Toxic epidermal necrolysis 695.19: Other erythema multiforme TO REPORT CHEMICAL AND TRAUMATIC INJURIES, USE THE FOLLOWING CODES 372.06: Acute chemical conjunctivitis 871.0: Ocular laceration without prolapse of intraocular tissue 871.1: Ocular laceration with prolapse or exposure of intraocular tissue 871.2: Rupture of eye with partial loss of intraocular tissue 871.3: Avulsion of eye 871.4: Unspecified laceration of eye 871.5: Penetration of eyeball with magnetic foreign body 871.6: Penetration of eyeball with (nonmagnetic) foreign body 871.7: Unspecified ocular penetration 871.9: Unspecified open wound of eyeball 918.0: Superficial injury of eyelids and periocular area 918.1: Superficial injury of cornea 918.9: Other and unspecified superficial injuries of eye 10 ICD-9 Code /Description Comment 940.2: Alkaline chemical burn of cornea and conjunctival sac 940.3: Acid chemical burn of cornea and conjunctival sac 940.4: Other burn of cornea and conjunctival sac TO REPORT POST-RADIOTHERAPY COMPLICATIONS, USE THE FOLLOWING CODE 990: Effects of radiation, unspecified TO REPORT RECURRENT EROSION AND CONGENITAL OR POST-SURGICAL LID DEFECTS, USE THE FOLLOWING CODES 371.42: Recurrent erosion of cornea 374.05: Trichiasis of eyelid without entropion 374.89: Other disorders of eyelid 374.9: Unspecified disorder of eyelid 743.62: Congenital deformity of eyelid 743.63: Other specified congenital anomaly of eyelid TO REPORT OCULAR CICATRICIAL PEMPHIGOID, USE THE FOLLOWING CODE 694.61: Benign mucous membrane pemphigoid with ocular involvement TO REPORT EXPOSURE KERATITIS, USE THE FOLLOWING CODE 370.34: Exposure keratoconjunctivitis TO REPORT LACRIMAL AND MEIBOMIAN DUCT OBLITERATION OR DEFICIENCY, USE THE FOLLOWING CODES 375.13: Primary lacrimal atrophy 375.14: Secondary lacrimal atrophy 375.15: Unspecified tear film insufficiency 375.69: Other change of lacrimal passages 375.89: Other disorder of lacrimal system 743.65: Specified congenital anomaly of lacrimal passages 743.9: Unspecified congenital anomaly of eye TO REPORT SUPERIOR LIMBAL KERATOCONJUNCTIVITIS, USE THE FOLLOWING CODES 11 ICD-9 Code /Description Comment 370.32: Limbar and corneal involvement in vernal conjunctivitis 370.49: Other unspecified keratoconjunctivitis TO REPORT SJÖGREN SYNDROME, USE THE FOLLOWING CODE 710.2: Sicca syndrome TO REPORT INFLAMMATORY CORNEAL DEGENERATION, USE THE FOLLOWING CODES 370.21: Punctate keratitis 371.40: Unspecified corneal degeneration 371.41: Senile corneal changes 371.43: Band-shaped keratopathy 371.44: Other calcerous degenerations of cornea 371.45: Keratomalacia NOS 371.46: Nodular degeneration of cornea 371.48: Peripheral degenerations of cornea 371.49: Other corneal degenerations 371.53: Granular corneal dystrophy 371.54: Lattice corneal dystrophy 371.55: Macular corneal dystrophy 371.60: Unspecified keratoconus 371.71: Corneal ectasia 371.9: Unspecified corneal disorder 372.31: Rosacea conjunctivitis 372.33: Conjunctivitis in mucocutaneous disease 372.64: Scarring of conjunctiva TO REPORT NEUROTROPHIC CORNEAL DISEASE, USE THE FOLLOWING CODE 370.35: Neurotrophic keratoconjunctivitis TO REPORT KERATOCONUS, USE THE FOLLOWING CODES 371.60: Unspecified keratoconus 12 ICD-9 Code /Description Comment 371.61: Keratoconus, stable condition 371.62: Keratoconus, acute hydrops TO REPORT BULLOUS KERATOPATHY, USE THE FOLLOWING CODE 371.23: Bullous keratopathy TO REPORT PERMANENT KERATOPROSTHESIS, USE THE FOLLOWING CODE V42.5: Cornea replaced by transplant TO REPORT FILAMENTARY KERATITIS, USE THE FOLLOWING CODE 370.23: Filamentary keratitis ICD-10 Code HCPCS Level II S0515 Description Description Scleral lens, liquid bandage device, per lens Comment Comment Key Code 13