mp-729 - mp-729 - Medical Policies

Last Review Date: August 2020

Category: Medicine

Policy Grade: B-

POLICY STATEMENT:

Effective for dates of service 9/11/2020 and after:

Computerized corneal topography (CCT) may be considered medically necessary for any of the following conditions:

• Bullous keratopathy
• Complication of ocular prosthetic device
• Complication of transplanted cornea
• Congenital corneal malformation
• Corneal ulcer, including Mooren’s ulcer
• Hereditary corneal dystrophies (including EBMD/Epithelial basement membrane dystrophy)
• Keratoconus (screening / monitoring)
• LSCD (Limbal stem cell deficiency)
• Nodular corneal degeneration (including Salzmann nodules)
• Peripheral corneal degeneration
• Post-penetrating keratoplasty surgery
• Post-traumatic corneal scarring
• Pre-operative evaluation of irregular astigmatism for intraocular lens power determination with cataract surgery
• Pseudopterygium
• Pterygium
• Severe dry eye

All other uses of computerized corneal topography (CCT) are considered not medically necessary (including, but not limited to):

• in relation to a non-covered eye procedure (e.g. refractive surgery)
• in relation to contact lens fitting
• routinely prior to cataract surgery
• to detect or monitor cataracts
• routine follow-up or screening

Effective for dates of service prior to 9/11/2020:

Computerized corneal topography (CCT) may be considered medically necessary for any of the following conditions:

• Cataracts
• Complication of ocular prosthetic device
• Complication of transplanted cornea
• Congenital corneal malformations
• Congenital glaucoma
• Corneal degeneration
• Corneal disorder due to contact lens
• Corneal ectasias
• Corneal scars and opacities
• Diabetic cataract/Diabetes mellitus
• Lens malformations
• Mooren’s corneal ulcer

• Pterygium
• Tuberculosis of the eye

All other uses of computerized corneal topography (CCT) are considered not medically necessary (including, but not limited to):

• in relation to a non-covered eye procedure (e.g. refractive surgery)
• in relation to contact lens fitting  
• routine follow-up or screening

DESCRIPTION OF PROCEDURE OR SERVICE

Computer-assisted corneal topography (also called photokeratoscopy or videokeratography) reveals much about the cornea, both quantitatively and qualitatively. There are various technologies and each device can provide a lot of different information. Corneal topography provides a quantitative measure of corneal curvature and corneal thickness. 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.

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. 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 two principal meridians, the keratometer can estimate the radius of curvature of two 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.

KEY POINTS

The most recent literature update was performed through July 1, 2020.

Table 1. Evaluation of Key Studies

UK: United Kingdom; KC: keratoconus; CCT: Computerized Corneal Topography; NR: not recorded; US: United States; SCL: scleral contact lens

Summary of Evidence

For individuals who have disorders of corneal topography who receive computer-assisted corneal topography/photokeratoscopy, the evidence includes only a few studies.

A study has been identified evaluating computer-assisted corneal topography as a clinical valid solution for diagnosing certain disorders of corneal topography. In it, authors concluded that TD and ORA, two vector parameters that could serve to detect clinical and subclinical keratoconus, were beneficial tools for detecting the disorder. The evidence is sufficient to determine the effects of the technology on health outcomes in certain disorders, including keratoconus.

Computer-assisted corneal topography lacks evidence from appropriately constructed clinical trials that could confirm whether it improves outcomes in other certain disorders, including microphthalmia, contact lens fitting, cataracts and glaucoma. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

The American Academy of Ophthalmology Cornea/External Disease Panel’s Preferred Practice Pattern on “Dry Eye Syndrome” (AAO, 2013) had no recommendation for computerized corneal topography.

A 1999 American Academy of Ophthalmology (AAO) assessment indicated that computer-assisted corneal topography evolved from the need to measure corneal curvature and topography more comprehensively and accurately than keratometry and that corneal topography is used primarily for refractive surgery.10, corneal astigmatism simulated keratometry (AAO) indicated several other potential uses: (1) to evaluate and manage patients following penetrating keratoplasty, (2) to plan astigmatic surgery, (3) to evaluate patients with unexplained visual loss and document visual complications, and (4) to fit contact lenses. However, the corneal astigmatism simulated keratometry (AAO) assessment noted the lack of data supporting the use of objective measurements (as opposed to subjective determinants, like subjective refraction) of astigmatism.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS

CCT, Computer assisted corneal topography, photokeratoscopy, videokeratography, corneal curvature, corneal disorders

APPROVED BY GOVERNING BODIES

A number of devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. In 1999, the Orbscan® (manufactured by Orbtek, distributed by Bausch and Lomb) was cleared by the FDA. 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. FDA product code: MXK.

Table 2. Corneal Topography Devices Clearing by the U.S. Food and Drug Administration

BENEFIT APPLICATION

Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING

CPT codes

REFERENCES

1. Agency for Healthcare Policy and Research (AHCPR), Cataract Management Guideline Panel. Cataract in adults: Management of functional impairment. Clinical Practice Guideline No. 4. AHCPR Pub. No. 93-0542. Rockville, MD: AHCPR; February 1993.
2. American Academy of Ophthalmology (AAO) Glaucoma Panel. Primary open-angle glaucoma. Preferred Practice Pattern. San Francisco, CA: AAO; October 2010.
3. American Academy of Ophthalmology (AAO), Anterior Segment Panel. Cataract in the adult eye. Preferred Practice Pattern. San Francisco, CA: AAO; 2006.
4. American Academy of Ophthalmology (AAO), Refractive Errors Panel. Refractive errors & refractive surgery. Preferred Practice Pattern. San Francisco, CA: AAO; October 2007.
5. American Academy of Ophthalmology (AAO). Corneal opacification and ectasia. Preferred Practice Pattern. San Francisco, CA: AAO; September 2000.
6. American Academy of Ophthalmology (AAO). Corneal topography. Ophthalmology. 1999; 106(8):1628-1638.
7. American Academy of Ophthalmology Cornea/External Disease Panel. Preferred Practice Pattern®Guidelines. Dry Eye Syndrome. San Francisco, CA: American Academy of Ophthalmology; 2013.
8. Baer AN. Diagnosis and classification of Sjogren's syndrome. UpToDate Inc., Waltham, MA. Last reviewed October 2018.
9. 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.
10. Caster AI, Friess DW, Schwendeman FJ. Incidence of epithelial ingrowth in primary and retreatment laser in situ keratomileusis. J Cataract Refract Surg. 2010; 36(1):97-101.
11. Cavas-Martinez F, De la Cruz Sanchez E, Nieto Martinez J, et al. Corneal topography in keratoconus: State of the art. Eye Vis (Lond). 2016; 3:5.
12. Choi JA, Kim MS. Progression of keratoconus by longitudinal assessment with corneal topography. Invest Ophthalmol Vis Sci. 2012; 53(2):927-935.
13. 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.
14. de Paiva CS, Lindsey JL, Pflugfelder SC. Assessing the severity of keratitis sicca with videokeratoscopic indices. Ophthalmology. 2003; 110(6):1102- 1109.
15. Garcia-Ferrer FJ, Akpek EK, Amescua G, et al; American Academy of Ophthalmology Preferred Practice Pattern Cornea and External Disease Panel. Corneal Ectasia Preferred Practice Pattern. Ophthalmology. 2019; 126(1):P170-P215.
16. Goggin M, Alpins N, Schmid LM. Management of irregular astigmatism. Curr Opin Ophthalmol. 2000; 11(4):260-266.
17. Gokul A, Vellara HR, Patel DV. Advanced anterior segment imaging in keratoconus: A review. Clin Exp Ophthalmol. 2018; 46(2):122-132.
18. Hu PH, Gao GP, Yu Y, et al. Analysis of corneal topography in patients with pure microphthalmia in Eastern China. J Int Med Res. 2015; 43(6):834-840.
19. Majmudar PA. Keratitis, interstitial. eMedicine Ophthalmology Topic 101. Omaha, NE: eMedicine.com; updated January 31, 2001. Available at: http://www.emedicine.com/oph/topic101.htm. Accessed July 9, 2003.
20. 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.
21. Morrow GL, Stein RM. Evaluation of corneal topography: Past, present and future trends. Can J Ophthalmol. 1992; 27(5):213-225.
22. Oshika T, Klyce SD. Corneal topography in LASIK. Semin Ophthalmol. 1998; 13(2):64-70.
23. Rao SK, Padmanabhan P. Understanding corneal topography. Curr Opin Ophthalmol. 2000; 11(4):248-259.
24. Rapuano CJ. Management of epithelial ingrowth after laser in situ keratomileusis on a tertiary care cornea service. Cornea. 2010; 29(3):307-313. Computerized Corneal Topography - Medical Clinical Policy Bulletins | Aetna Page 10 of 12 http://www.aetna.com/cpb/medical/data/100_199/0130.html 6/22/2020
25. Sade de Paiva C, Lindsey JL, Pflugfelder SC. Assessing the severity of keratitis sicca with videokeratoscopic indices. Ophthalmology. 2003; 110 (6):1102-1109.
26. Sanders DR, Gills JP, Martin RG. When keratometric measurements do not accurately reflect corneal topography. J Cataract Refract Surg. 1993; 19 Suppl: 131-135.
27. Seitz B, Behrens A, Langenbucher A. Corneal topography. Curr Opin Ophthalmol. 1997; 8(4):8-24.
28. Sherwin T, Brookes NH. Morphological changes in keratoconus: Pathology or pathogenesis. Clin Experiment Ophthalmol. 2004; 32(2):211-217.
29. Sultan G, Baudouin C, Auzerie O, et al. Cornea in Marfan disease: Orbscan and in vivo confocal microscopy analysis. Invest Ophthalmol Vis Sci. 2002; 43(6):1757-1764.
30. Tummanapalli SS, Potluri H, Vaddavalli PK, Sangwan VS. Efficacy of axial and tangential corneal topography maps in detecting subclinical keratoconus. J Cataract Refract Surg. 2015; 41(10):2205-2214.
31. Visser N, Berendschot TT, Verbakel F, et al. Comparability and repeatability of corneal astigmatism measurements using different measurement technologies. J Cataract Refract Surg. 2012; 38(10):1764-1770.
32. Wayman LL. Keratoconus. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed November 2015.
33. 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.
34. White ML, Chodosh J. Herpes simplex virus keratitis: A treatment guideline – 2014. June 2014. Available at: https://www.aao.org/clinicalstatement/herpes-simplex-virus-keratitis-treatment-guideline. Accessed October 8, 2018.
35. Wilson SE, Ambrisio R. Computerized corneal topography and its importance to wavefront technology. Cornea. 2001; 20(5):441-454.
36. Wilson SE, Klyce SD. Advances in the analysis of corneal topography. Surv Ophthalmol. 1991; 35(4):269-277.
37. Wolffsohn JS, Peterson RC. Anterior ophthalmic imaging. Clin Exp Optom. 2006; 89(4):205-214.

POLICY HISTORY

Medical Policy Group, July 2020 (9): New policy. Effective 9/11/2020. Coverage previously allowed per internal processing guidelines detailed in policy statement section “effective for dates of service prior to 9/11/2020”.

Medical Policy Administration Committee, August 2020

Available for comment 7/28/2020 through 9/11/2020.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.