Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Contact Lenses for the Treatment of Persistent (Corneal) Epithelial Defects

Policy #:07.13.11i

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

The use of either rigid gas-permeable scleral contact lenses (e.g., BOSTON® Scleral Lens, now known as the BostonSight® PROSE device) or therapeutic soft contact lenses (e.g., Focus® Night & Day® Lens) as corneal liquid bandages is considered medically necessary and, therefore, covered for individuals who meet both of the following criteria:
  • The individual has persistent epithelial defects (PEDs) of the cornea with documented, disabling symptoms (e.g., pain, photophobia) that have not responded to medical intervention.
  • The individual has any of the following conditions for which surgery is undesirable and/or contraindicated:
    • Stevens-Johnson disease (a syndrome of systemic, as well as more severe, mucocutaneous lesions that results in corneal opacities, perforations, and/or blindness)
    • Conditions that result from a chemical and/or traumatic injury
    • Postradiotherapy complications
    • Recurrent corneal erosion
    • Congenital and/or postsurgical eyelid defect(s)
    • Ocular cicatricial pemphigoid
    • Exposure keratitis
    • Toxic epidermal necrolysis
    • Lacrimal and/or meibomian gland obliteration or deficiency
    • Superior limbal keratoconjunctivitis
    • Sjögren syndrome
    • Inflammatory corneal degeneration
    • Neurotrophic corneal disease (e.g., corneal denervation that is related to acoustic neuroma surgery, trigeminal ganglion obliteration, diabetes mellitus, herpetic syndrome, congenital dysautonomia [e.g., Riley-Day syndrome])
    • PED resulting from superior limbic keratotomy
    • Corneal ectatic disorders (e.g., keratoconus, keratoglobus, pellucid marginal degeneration, Terrien’s marginal degeneration, Fuchs’ superficial marginal keratitis, post-surgical ectasia)
    • Chronic ocular graft-versus-host disease (GVHD)
    • Irregular corneal astigmatism (e.g., after keratoplasty, photorefractive keratectomy, other corneal surgery)
    • Post-ocular surface tumor excision

The use of therapeutic soft contact lenses as corneal liquid bandages is considered medically necessary and, therefore, covered for individuals who meet both of the following criteria:
  • The individual has a PED with documented, disabling symptoms (e.g., pain, photophobia) that have not responded to medical intervention.
  • The PED is associated with any of the following conditions:
    • Bullous keratopathy
    • Permanent keratoprosthesis
    • Filamentary keratitis
    • PEDs resulting from penetrating keratoplasty
    • Following the use of cyanoacrylate (tissue) glue to provide protection to this adhesive plug over a corneal wound

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the health care professional's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, corneal liquid bandages are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

THE BOSTON® SCLERAL LENS (BSL) -- (NOW KNOWN AS BOSTONSIGHT® PROSE DEVICE)

The BOSTON® Scleral Lens (BSL) and all care associated with its fitting are only available at the Boston Foundation for Sight (Needham Heights, MA).

Other lenses (including rigid gas-permeable lenses and therapeutic soft lenses) may be available through Company-contracted providers.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The BSL was approved by the FDA on March 1, 1994. Supplemental approvals for rigid gas-permeable scleral and soft therapeutic contact lenses have since been issued by the FDA.

BSL is now known as the BOSTONSIGHT® PROSE DEVICE.
Description

The term corneal liquid bandage applies to both rigid gas-permeable scleral contact lenses (RGP-ScCLs) and therapeutic soft contact lenses (TSCLs). Corneal liquid bandages cover the cornea and sometimes the adjacent portion of the white of the eye (sclera) and are used in the treatment of acute or chronic corneal pathology such as persistent epithelial defects (PEDs). PEDs are defined as lesions or serious deformities of the cornea that persist despite the use of conventional therapies. PEDs are associated with certain systemic or eye diseases and/or may develop following penetrating keratoplasty (PK). Corneal liquid bandages protect the corneal surface from the drying effects of exposure to air and the friction of blinking. They also significantly reduce the intensity of ocular pain and photophobia associated with ocular surface disease and facilitate the healing of PEDs. Corneal liquid bandages can also eliminate superficial corneal irregularities and thus may improve visual acuity during treatment.

The objectives of corneal liquid bandages are summarized as:
  • Relief of ocular pain
  • Promotion of corneal healing
  • Mechanical protection and support
  • Maintenance of corneal epithelial hydration
  • Installation of medications

Corneal liquid bandages are utilized in a large variety of ophthalmic disorders and are considered one of various treatment options. The choice of lens depends on the clinical effect best suited to the corneal condition, though typically TSCLs are tried first.

TYPES OF CORNEAL LIQUID BANDAGES

RIGID GAS-PERMEABLE SCLERAL CONTACT LENSES (RGP-ScCLs)
In the United States (US), scleral contact lenses were previously most often made of a rigid plastic. However, in recent years, a gas-permeable polymer plastic (e.g., fluorosilicone/acrylate polymer) has been used to make these lenses, which are now referred to as RGP-ScCLs. RGP-ScCLs are promoted for daily use and, in some instances, extended use in the treatment of PEDs.

The BOSTON® Scleral Lens (BSL) (now known as the BostonSight® PROSE device), which is more specifically termed the BOSTON® Equalens® II, is a RGP-ScCL commercially available in the US that can be post-fabricated for the treatment of PEDs. Currently, it is manufactured and distributed by the Boston Foundation for Sight (BFS) (Needham Heights, MA). The BSL, unlike a traditional rigid gas-permeable contact lens, is a specially designed, fluid-ventilated, gas-permeable scleral contact lens. It is designed to maintain a bubble-free reservoir of oxygenated aqueous fluid over the corneal surface at a neutral hydrostatic pressure. Due to the fact that air bubbles are avoided, the fluid reservoir functions as a corneal liquid bandage that offers unique therapeutic benefits for the management of severe ocular surface disease, in addition to its traditional role of masking irregular corneal astigmatism.

In addition to BSL, additional sclera lens designs are also available (e.g., the Jupiter Mini-scleral gas-permeable contact lens). Although these come in various diameters, they are not custom fitted to each individual’s condition.

THERAPEUTIC SOFT CONTACT LENSES (TSCLs)
TSCLs are made of poly(2-hydroxyethyl methacrylate) or other polymer materials that are hydrophilic to absorb or attract a certain volume of water. These soft lenses are intended to be worn directly against the cornea and adjacent to the limbal and scleral areas of the eye to act as a corneal bandage in the treatment of acute or chronic corneal pathology such as PEDs. There are many types of soft lenses available for therapeutic use (e.g., Focus® Night & Day® Lens [CIBA Vision® Corporation, Duluth, GA; now Alcon Laboratories, Inc. Fort Worth, TX]). The cause of the PED should dictate which type of lens is used.

Indications associated with PEDs, and for which corneal liquid bandages (RGP-ScCLs and TSCLs) are sometimes recommended, include:
  • Stevens-Johnson disease (a syndrome of systemic, as well as more severe, mucocutaneous lesions that results in corneal opacities, perforations, and/or blindness)
  • Conditions that result from a chemical and/or traumatic injury
  • Postradiotherapy complications
  • Recurrent corneal erosion
  • Congenital and/or postsurgical eyelid defect(s)
  • Ocular cicatricial pemphigoid
  • Exposure keratitis
  • Toxic epidermal necrolysis
  • Congenital deficiency of the meibomian gland
  • Superior limbal keratoconjunctivitis
  • Sjögren syndrome
  • Inflammatory corneal degeneration
  • Neurotrophic corneal disease(s) (e.g., corneal denervation that is related to acoustic neuroma surgery, trigeminal ganglion obliteration, diabetes mellitus, herpetic syndrome, congenital dysautonomia [e.g., Riley-Day syndrome])
  • PEDs resulting from superior limbic keratotomy
  • Corneal ectatic disorders (e.g., keratoconus, keratoglobus, pellucid marginal degeneration, Terrien’s marginal degeneration, Fuchs’ superficial marginal keratitis, post-surgical ectasia
  • Chronic ocular graft-versus-host disease (GVHD)
  • Irregular corneal astigmatism (e.g., after keratoplasty, photorefractive keratectomy, other corneal surgery)
  • Post-ocular surface tumor excision

Additional indications where TSCLs are sometimes recommended include:
  • Bullous keratopathy
  • Permanent keratoprosthesis
  • Filamentary keratitis
  • PEDs resulting from penetrating keratoplasty
  • Following the use of cyanoacrylate (tissue) glue to provide protection to this adhesive plug over a corneal wound

References

American Academy of Ophthalmology. EyeWiki™. BostonSight PROSE (Prosthetic replacement of the ocular surface ecosystem). Last modified 09/27/2017. Available at: http://eyewiki.aao.org/BostonSight_PROSE_(Prosthetic_replacement_of_the_ocular_surface_ecosystem). Accessed June 12, 2018.


American Academy of Ophthalmology. EyeWiki™. Corneal Epithelial Defect. Last modified 12/19/2017. Available at: http://eyewiki.aao.org/Corneal_Epithelial_Defect. Accessed June 12, 2018.

Baran I, Bradley JA, Alipour F, et al. PROSE treatment of corneal ectasia. Cont Lens Anterior Eye. 2012;35(5):222-227.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 80.1: Hydrophilic contact lens for corneal bandage. [CMS Web site]. ND. Available at:
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=136&ncdver=1&bc=AAAAQAAAAAAA&. Accessed June 8, 2018.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 80.5: Scleral Shell. [CMS Web site]. ND. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=235&ncdver=1&bc=AgAAQAAAAAAA&. Accessed June 8, 2018.

Ciralsky JB, Chapman KO, Rosenblatt MI, et al. Treatment of Refractory Persistent Corneal Epithelial Defects: A Standardized Approach Using Continuous Wear PROSE Therapy. Ocul Immunol Inflamm. 2015;23(3):219-24.

Gungor I, Schor K, Rosenthal P, et al. The Boston Scleral Lens in the treatment of pediatric patients. J AAPOS. 2008;12(3):263-267.

Jacobs DS, Rosenthal P. Boston sclera lens prosthetic device for treatment of severe dry eye in chronic graft-versus host disease. Cornea. 2007; 26(10):1195-9.

Jupiter DG, Katz HR. Management of irregular astigmatism with rigid gas permeable contact lenses. CLAO J. 2000; 26(1):14-7.

Kok JH, Visser R. Treatment of ocular surface disorders and dry eyes with high gas-permeable scleral lenses. Cornea.1992;11(6):518-522.

Pecego M, Barnett M, Mannis MJ, et al. Jupiter Scleral Lenses: the UC Davis Eye Center experience. Eye Contact Lens. 2012; 38(3):179-82.

Puangsricharern V, Tseng SC. Cytologic evidence of corneal diseases with limbal stem cell deficiency. Ophthalmology.1995;102(10):1476-1485.

Pullum KW, Buckley RJ. A study of 530 patients referred for rigid gas permeable scleral contact lens assessment. Cornea.1997;16(6):612-622.

Romero-Rangel T, Stavrou P, Cotter J, et al. Gas-permeable scleral contact lens therapy in ocular surface disease. Am J Ophthalmol. 2000;130(1):25-32.

Rosenthal P, Cotter J. The Boston Scleral Lens in the management of severe ocular surface disease. Ophthalmol Clin North Am. 2003;16(1):89-93.

Rosenthal P, Cotter JM, Baum J. Treatment of persistent corneal epithelial defect with extended wear of a fluid-ventilated gas-permeable scleral contact lens. Am J Ophthalmol. 2000;130(1):33-41.

Rosenthal P, Croteau A. Fluid-ventilated, gas-permeable scleral contact lens is an effective option for managing severe ocular surface disease and many corneal disorders that would otherwise require penetrating keratoplasty. Eye Contact Lens. 2005;31 (3):130-134.

Rosenthal P, Jacobs DS, Johns L. Fluid-ventilated gas permeable scleral lens: a new paradigm for the management of irregular corneal astigmatism and severe ocular surface disease. Contemporary Ophthalmology.2006;5(22):1-7.

Segal O, Barkana Y, Hourovitz D, et al. Scleral contact lenses may help where other modalities fail. Cornea. 2003;22(4):308-310.

Shipra Gupta S, Gupta P, Sayegh R. Healing a Persistent Corneal Epithelial Defect. EyeNet Magazine. August 2014. Available at: https://www.aao.org/eyenet/article/healing-persistent-corneal-epithelial-defect. Accessed June 12, 2018.

Schornack MM, Patel SV. Scleral lenses in the management of keratoconus. Eye Contact Lens. 2010; 36(1):39-44.

Schornack MM, Pyle J, Patel SV. Scleral lenses in the management of ocular surface disease. Ophthalmology. 2014;121(7):1398-1405.

Smith GT, Mireskandari K, Pullum KW. Corneal swelling with overnight wear of scleral contact lenses. Cornea. 2004;23(1):29-34.

Stason WB, Razavi M, Jacobs DS, et al. Clinical benefits of the Boston Ocular Surface Prosthesis. Am J Ophthalmol. 2010; 149(1):54.61.

Steele CF. Fitting and management of therapeutic contact lenses. Hospital optometrists information series. November 2000. Available at: http://www.spitjudms.ro/_files/protocoale_terapeutice/oftalmologie/fm-tcl-info1.pdf. Accessed June 8, 2018.

Tan DT, Pullum KW, Buckley RJ. Medical applications of scleral contact lenses: 2. Gas-permeable scleral contact lenses. Cornea. 1995;14(2):130-137.

Tappin MJ, Pullum KW, Buckley RJ. Scleral contact lenses for overnight wear in the management of ocular surface disorders. Eye (Lond). 2001;15(Pt 2):168-172.

Tseng SC, Tsubota K. Important concepts for treating ocular surface and tear disorders. Am J Ophthalmol. 1997;124(6):825-835.

US Department of Health and Human Services, Health Care Financing Administration (HCFA). Hydrophilic contact lens for corneal bandage. Medicare Coverage Issues Manual §45-7. Baltimore, MD: HCFA; 1999. Revised 2010.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. BOSTON(R) EQUALENS (R) SCLERAL CONTACT LENS DESIGN. Premarket Approval (PMA) Database. [FDA Web site]. 03/19/03. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860022S040. Accessed June 12, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. NIGHT & DAY 30 NIGHT EXTENDED WEAR SOFT CONTACT LENS. Premarket Approval (PMA) Database. [FDA Web site]. 03/19/03. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010019S002. Accessed June 12, 2018.

US Food and Drug Administration (FDA): Product classification: Rigid gas permeable contact lens. [FDA website]. Updated June 4, 2018. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=4286.Accessed June 8, 2018.

Visser ES, Visser R, van Lier HJ, et al. Modern scleral lenses part I: clinical features. Eye Contact Lens. 2007;33(1):13-20.




Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment A


HCPCS Level II Code Number(s)



S0515 Scleral lens, liquid bandage device, per lens

V2531 Contact lens, scleral, gas permeable, per lens (for contact lens modification, see 92325)


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment

A:
Contact Lenses for the Treatment of Persistent (Corneal) Epithelial Defects
Description: ICD-10 Codes




Policy History

Revisions from 07.13.11i
10/01/2018This version of the policy will become effective 10/01/2018. The following ICD-10 codes have been added to the policy: H02.881, H02.882, H02.883, H02.884,H02.885, H02.886, H02.889, H02.88A, H02.88B, H10.821, H10.822, H10.823, H10.829.
Revisions from 07.13.11h
07/03/2018Effective 03/28/2018, this policy has undergone a routine review, and no revisions have been made.
03/28/2017This version of the policy will become effective on 03/28/2018.

The policy has been reviewed to communicate the Company’s continuing position on Contact Lenses for the Treatment of Persistent (Corneal) Epithelial Defects.

The BOSTON® Scleral Lens (BSL) is now known as the BostonSight® PROSE device.

Effective 10/05/2017 this policy has been updated to the new policy template format.
Version Effective Date: 10/01/2018
Version Issued Date: 10/01/2018
Version Reissued Date: N/A

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