BCBSNJ Medical Policy for - (Medicine) Policy Number

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Horizon BCBSNJ
Uniform Medical Policy Manual	Section:	Medicine
	Policy Number:	003
	Effective Date:	05/23/1997

	Original Policy Date:	05/23/1997
	Last Review Date:	04/14/2020
	Date Published to Web:	07/14/2006

Subject:
Computerized Corneal Topography/Videokeratography

Description:
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IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Computer-assisted corneal topography (also called photokeratoscopy or videokeratography) provides a quantitative measure of corneal curvature. Measurement of corneal topography is being evaluated to aid the diagnosis of and follow-up for corneal disorders such as keratoconus, difficult contact lens fits, and pre- and postoperative assessment of the cornea, most commonly after refractive surgery.

Populations	Interventions	Comparators	Outcomes
Individuals: With disorders of corneal topography	Interventions of interest are: Computer-assisted corneal topography/photokeratoscopy	Comparators of interest are: Manual corneal topography measurements	Relevant outcomes include: Test accuracy Other test performance measures Functional outcomes

BACKGROUND

Detection and Monitoring Diseases of the Cornea

Corneal topography describes measurements of the curvature of the cornea. An evaluation of corneal topography is necessary for the accurate diagnosis and follow-up of certain corneal disorders, such as keratoconus, difficult contact lens fits, and pre- and postoperative assessment of the cornea, most commonly after refractive surgery.

Assessing corneal topography is a part of the standard ophthalmologic examination of some patients.^1,^2, Corneal topography can be evaluated and determined in multiple ways. Computer-assisted corneal topography has been used for early identification and quantitative documentation of the progression of keratoconic corneas, and evidence is sufficient to indicate that computer-assisted topographic mapping can detect and monitor disease.

Various techniques and instruments are available to measure corneal topography: keratometer, keratoscope, and computer-assisted photokeratoscopy.

The keratometer (also referred to as an ophthalmometer), the most commonly used instrument, projects an illuminated image onto a central area in the cornea. By measuring the distance between a pair of reflected points in both of the cornea’s 2 principal meridians, the keratometer can estimate the radius of curvature of 2 meridians. Limitations of this technique include the fact that the keratometer can only estimate the corneal curvature over a small percentage of its surface and that estimates are based on the frequently incorrect assumption that the cornea is spherical.

The keratoscope reflects a series of concentric circular rings off the anterior corneal surface. Visual inspection of the shape and spacing of the concentric rings provides a qualitative assessment of topography.

A photokeratoscope is a keratoscope equipped with a camera that can provide a permanent record of the corneal topography. Computer-assisted photokeratoscopy is an alternative to keratometry or keratoscopy for measuring corneal curvature. This technique uses sophisticated image analysis programs to provide quantitative corneal topographic data. Early computer-based programs were combined with keratoscopy to create graphic displays and high-resolution, color-coded maps of the corneal surface. Newer technologies measure both curvature and shape, enabling quantitative assessment of corneal depth, elevation, and power.

Regulatory Status

A number of devices have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process. In 1999, the Orbscan® (manufactured by Orbtek, distributed by Bausch and Lomb) was cleared by the Food and Drug Administration. The second-generation Orbscan II is a hybrid system that uses both projective (slit scanning) and reflective (Placido) methods. The Pentacam® (Oculus) is one of a number of rotating Scheimpflug imaging systems produced in Germany. In 2005, the Pentacam HR was released with a newly designed high-resolution camera and improved optics. Food and Drug Administration product code: MXK.

Table 1. Corneal Topography Devices Clearing by the US Food and Drug Administration

Device
Manufacturer
Date Cleared
510.k No.
Indication

VX130 Ophthalmic Diagnostic Device LUNEAU SAS 4/24/2017 K162067 To scan, map and display the geometry of the anterior segment of the eye

Pentacam AXL OCULUS OPTIKGERATE GMBH 1/20/2016 K152311 To scan, map and display the geometry of the anterior segment of the eye

ARGOS SANTEC CORPORATION 10/2/2015 K150754 To scan, map and display the geometry of the anterior segment of the eye

ALLEGRO OCULYZER WAVELIGHT AG 7/20/2007 K071183 To scan, map and display the geometry of the anterior segment of the eye

HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) HEIDELBERG ENGINEERING 1/13/2006 K052935 To scan, map and display the geometry of the anterior segment of the eye

CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA SIS LTD. SURGICAL INSTRUMENT SYSTEMS 9/28/2005 K051940 To scan, map and display the geometry of the anterior segment of the eye

PATHFINDER MASSIE RESEARCH LABORATORIES INC. 9/2/2004 K031788 To scan, map and display the geometry of the anterior segment of the eye

NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) BAUSCH & LOMB 7/23/2004 K040913 To scan, map and display the geometry of the anterior segment of the eye

PENTACAM SCHEIMPFLUG CAMERA OCULUS OPTIKGERATE GMBH 9/16/2003 K030719 To scan, map and display the geometry of the anterior segment of the eye

ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM NIDEK INC. 8/6/1999 K991284 To scan, map and display the geometry of the anterior segment of the eye

ORBSCAN TECHNOLAS PERFECT VISION GMBH 3/5/1999 K984443 To scan, map and display the geometry of the anterior segment of the eye

VX130 Ophthalmic Diagnostic Device LUNEAU SAS 4/24/2017 K162067 To scan, map and display the geometry of the anterior segment of the eye

Related Policies

Implantation of Intrastromal Corneal Ring Segments (Policy #058 in the Surgery Section)
Corneal Collagen Cross-Linking (Policy #141 in the Treatment Section)

Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)

1. Computerized corneal topography or videokeratography is considered medically necessary in the evaluation of members for any of the following conditions:

2. Computerized corneal topography is primarily a diagnostic test and routine "serial" testing is not considered medically necessary. Repeat testing may be necessary in members with any of the above-listed conditions who note a change in vision.

3. Computerized corneal topography is not considered medically necessary when it is used as fitting aid of contact lenses and as a supplier of data for computer aided design or manufacture of contact lenses.

4. Computerized corneal topography is not considered medically necessary when performed in conjunction with procedures considered by Horizon Blue Cross Blue Shield of New Jersey as cosmetic or investigational (e.g. radial keratotomy).

5. Routine "comparison" topographic scans are not medically necessary.

Medicare Coverage:
There is no National Coverage Determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for this service. Therefore, Medicare Advantage Products will follow the Horizon Policy.

Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

FIDE SNP:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Computerized Corneal Topography/Videokeratography
Computerized Corneal Topography
Corneal Mapping
Corneal Topography
Keratometer
Keratoscope
Photokeratoscope
Topography, Corneal
Videokeratography
Ophthalmometer
Computer-Assisted Photokeratoscopy
Orbscan®
Pentacam®

References:
1. Morrow GL, Stein RM. Evaluation of corneal topography: past, present and future trends. Can J Ophthalmol. Aug 1992;27(5):213-225. PMID 1393805.

2. Wilson SE, Klyce SD. Advances in the analysis of corneal topography. Surv Ophthalmol. Jan-Feb 1991;35(4):269-277. PMID 2011820.

3. Martinez-Abad A, Pinero DP, Ruiz-Fortes P, et al. Evaluation of the diagnostic ability of vector parameters characterizing the corneal astigmatism and regularity in clinical and subclinical keratoconus. Cont Lens Anterior Eye. Apr 2017;40(2):88-96. PMID 27931882.

4. Bhatoa NS, Hau S, Ehrlich DP. A comparison of a topography-based rigid gas permeable contact lens design with a conventionally fitted lens in patients with keratoconus. Cont Lens Anterior Eye. Jun 2010;33(3):128-135. PMID 20053579.

5. Weber SL, Ambrosio R, Jr., Lipener C, et al. The use of ocular anatomical measurements using a rotating Scheimpflug camera to assist in the Esclera(R) scleral contact lens fitting process. Cont Lens Anterior Eye. Apr 2016;39(2):148-153. PMID 26474924.

6. DeNaeyer G, Sanders DR, Farajian TS. Surface coverage with single vs. multiple gaze surface topography to fit scleral lenses. Cont Lens Anterior Eye. Jun 2017;40(3):162-169. PMID 28336224.

7. Bandlitz S, Baumer J, Conrad U, et al. Scleral topography analysed by optical coherence tomography. Cont Lens Anterior Eye. Aug 2017;40(4):242-247. PMID 28495356.

8. Lee H, Chung JL, Kim EK, et al. Univariate and bivariate polar value analysis of corneal astigmatism measurements obtained with 6 instruments. J Cataract Refract Surg. Sep 2012;38(9):1608-1615. PMID 22795977.

9. de Sanctis U, Donna P, Penna RR, et al. Corneal astigmatism measurement by ray tracing versus anterior surface-based keratometry in candidates for toric intraocular lens implantation. Am J Ophthalmol. May 2017;177:1-8. PMID 28185842.

10. Ophthalmic Technology Assessment Committee Cornea Panel American Academy of Ophthalmology. Corneal topography. American Academy of Ophthalmology. Ophthalmology. Aug 1999;106(8):1628-1638. PMID 10442914.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

HCPCS

* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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