Latest Review Date: August 2024

Category: Vision                                                                 

POLICY:

Corneal pachymetry may be considered medically necessary, once in a lifetime, when performed for the following diagnoses (See Benefit Application):

• Glaucoma; or
• Glaucomatocyclitic crises; or
• Glaucomatous atrophy (cupping) of optic disc; or
• Recession of chamber angle of eye

Corneal pachymetry may be considered medically necessary when performed not more frequently than every six months for the following diagnoses:

• Bullous keratopathy; or
• Corneal edema; or
• Corneal deformities; or
• Corneal degeneration; or
• Corneal rejection post penetrating keratopathy; or
• Cornea transplant; or
• Fuchs endothelial dystrophy; or
• Keratoconus; or 
• Post corneal transplant; or
• Posterior polymorphous dystrophy

Corneal pachymetry is considered investigational when performed for routine screening services (e.g., glaucoma screening, routine vision screening).

Corneal pachymetry is considered investigational when used to evaluate refractory errors and as a contract exclusion.  (See Benefit Application)

DESCRIPTION OF PROCEDURE OR SERVICE:

Corneal pachymetry is a non-invasive ultrasonic technique for measuring corneal thickness and has been used primarily in the evaluation of persons with corneal diseases and in the assessment of persons at risk for glaucoma. Ultrasonic corneal pachymetry is performed by placing an ultrasonic probe on the central cornea, after the cornea has been anesthetized with a topical anesthetic. A technician can operate the pachymeter and it normally takes less than 30 seconds per eye to complete measurements.

Corneal thickness is an important indication of the health and function of the cornea. Measurement of corneal thickness is useful for the diagnosis of certain corneal diseases, in determining the effectiveness of specific ophthalmologic medical and surgical treatments such as corneal transplant, penetrating keratoplasty and refractive surgeries and in the evaluation of contact lens wear.

Central corneal thickness has been found to be of predictive value for the development of glaucoma in individuals with ocular hypertension. Several techniques have been developed for the clinical measurement of corneal thickness with ultrasound pachymetry considered the gold standard.

KEY POINTS:

The most recent literature review for this policy was performed August 15, 2024.

Summary of Evidence

Measurement of corneal thickness may be beneficial in clinical decision-making and/or management of corneal disease. There is insufficient evidence in the available published, peer-reviewed medical literature to support the use of corneal pachymetry outside of the established indications. The evidence is sufficient to determine that the technology results in an improvement in the overall health outcomes. The procedure’s clinical efficacy is proven for the established indications.

Practice Guidelines and Position Statements

American Academy of Ophthalmology

The American Academy of Ophthalmology Preferred Practice Pattern on Evaluation of the Glaucoma Suspect (2020) concludes that appropriate testing to evaluate and monitor individuals diagnosed as glaucoma suspect includes (among other techniques) pachymetry.

The American Academy of Ophthalmology Preferred Practice Pattern on Corneal Edema and Opacification (2024) concludes that corneal pachymetry, measured in the morning, is a helpful indicator of the ability of the endothelium to regulate corneal hydration appropriately.

U.S. Preventative Task Force Recommendations

Not applicable.

KEY WORDS:

Corneal pachymetry, pachymetry, pachymeter, corneal thickness, intraocular pressure, ultrasound pachymetry, optical pachymetry, refractory surgery, IOP, primary open angle glaucoma, POAG, ocular hypertension, central corneal thickness, CCT, Corneal Waveform (CWF), Pachmate®, PalmScan P2000E, Corvis ST

APPROVED BY GOVERNING BODIES:

A number of corneal pachymetry devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process (Table 1).

Table 1. Corneal Pachymetry Devices Cleared by the U.S. Food and Drug Administration

BENEFIT APPLICATION:

In general, contracts exclude “services for eye exercises, eye refractions, visual training orthoptics, shaping the cornea with contact lenses, or any surgery on the eye to improve vision including radial keratotomy.”

Diagnosis codes covered for once per lifetime procedure of corneal pachymetry may be considered medically necessary. Additional testing for these diagnosis codes should not be necessary unless an individual transfers to another practice or there are corneal changes. If corneal changes occur, then the appropriate diagnosis code should be filed. Procedures performed beyond the once per lifetime limit should include documentation of change in practice or change in condition.

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

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

CPT codes:

REFERENCES:

1. Bohm M, Shajari M, Remy M, Kohnen T. Corneal densitometry after accelerated corneal collagen cross-linking in progressive keratoconus. Int Ophthalmol. 2019; 39(4): 765-775.
2. Camburu G, Zemba M, Tătaru CP, Purcărea VL. The measurement of Central Corneal Thickness. Rom J Ophthalmol. 2023; 67(2): 168-174.
3. Center for Devices and Radiological Health. Medical device databases. U.S. Food and Drug Administration. 2012. www.accessdata.fda.gov/cdrh_docs/pdf11/K113066.pdf.
4. Garza-Leon M, Plancarte-Lozano E, Valle-Penella AD, Guzmán-Martínez ML, Villarreal-González A. Reproducibility of the measurement of central corneal thickness in healthy subjects obtained with the optical low coherence reflectometry pachymeter and comparison with the ultrasonic pachymetry. Cir Cir. 2019; 86(1): 44-49. English.
5. Gedde SJ, Lind JT, Wright MM, et al. Primary Open-Angle Glaucoma Suspect Preferred Practice Pattern®. Ophthalmology. 2021;128(1): P151-P192.
6. Gharieb HM, Ashour DM, Saleh MI, Othman IS. Measurement of central corneal thickness using Orbscan 3, Pentacam HR and ultrasound pachymetry in normal eyes. Int Ophthalmol. 2020; 40(7):1759-1764.
7. González-Pérez J, Queiruga Piñeiro J, Sánchez García Á, González Méijome JM. Comparison of Central Corneal Thickness Measured by Standard Ultrasound Pachymetry, Corneal Topography, Tono-Pachymetry and Anterior Segment Optical Coherence Tomography. Curr Eye Res. 2018; 43(7): 866-872.
8. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
9. Kim JS, Rho CR, Cho YW, Shin J. Comparison of corneal thickness measurements using ultrasound pachymetry, noncontact tonopachy, Pentacam HR, and Fourier-domain OCT. Medicine (Baltimore). 2021;100(16): e25638.
10. Maloca PM, Studer HP, Ambrósio R Jr, Goldblum D, Rothenbuehler S, Barthelmes D, Zweifel S, Scholl HPN, Balaskas K, Tufail A, Hasler PW. Interdevice variability of central corneal thickness measurement. PLoS One. 2018 Sep 13; 13(9): e0203884. 
11. Mian SI, Viriya ET, Ahmad S, et al. Corneal Edema and Opacification Preferred Practice Pattern®. Ophthalmology. 2024;131(4): P247-P305.
12. Santodomingo-Rubido J, Carracedo G, Suzaki A, Villa-Collar C, Vincent SJ, Wolffsohn JS. Keratoconus: An updated review. Cont Lens Anterior Eye. 2022 Jun; 45(3): 101559.
13. Schröder S, Langenbucher A, Schrecker J (2019) Comparison of corneal elevation and pachymetry measurements made by two state of the art corneal tomographers with different measurement principles. PLoS ONE 14(10): e0223770.
14. Tutchenko L, Patel S, Horak O, Sanin V, Kosuba S. Effect of Cataract Surgery on the Refractive Index of the Cornea Estimated by Optical Pachymetry. Cornea. 2018 Nov;37(11):1414-1420.
15. Villavicencio, Ovette MD, PhD; Belin, Michael W. MD; Ambrósio, Renato Jr. MD, PhD; Steinmueller, Andreas MSc. Corneal pachymetry: New ways to look at an old measurement. Journal of Cataract & Refractive Surgery 40(5): p695-701, May 2014.
16. Vonor K, Amedome KM, Santos MAK, et al. Accuracy of optical coherence tomography versus ultrasound in pachymetry. J Fr Ophtalmol. 2021; 44(7):1047-1051.

POLICY HISTORY:

Medical Policy Group, July 2003 (1)

Medical Policy Administration Committee, July 2003

Available for comment, July 14-August 27, 2003

Medical Review Committee, May 2004

Medical Policy Administration Committee, June 2004

Available for comment June 28-August 11, 2004

Medical Policy Group, May 2005 (1)

Medical Policy Group, June 2006 (1)

Medical Policy Administration Committee, July 2006

Available for comment July 18-August 31, 2006

Medical Policy Group, November 2007 (1)

Medical Policy Group, September 2008 (2)

Medical Policy Administration Committee, October 2008

Available for comment September 19-November 3, 2008

Medical Policy Group, March 2010 (1):  Effective March 1, 2010: Active policy, but no longer scheduled for regular literature reviews. Updated Key Points, no policy change.

Medical Policy Group, October 2013 (1): Removed ICD-9 Diagnosis codes; Added description of diagnosis removed; no change to policy statement.

Medical Policy Group, January 2015 (6):  Ad hoc review based on provider request - Updated References; no change in policy statement; policy remains retired

Medical Policy Group, August 2019 (6): Updates to Description, Key Points and Key Words (Corneal Waveform (CWF), Pachmate®, PalmScan P2000E). No change to policy intent.

Medical Policy Group, March 2021 (9): Updates to Key Points, References. Policy statement updated to alphabetize diagnosis bullets and add the word “or” after each diagnosis, no change to policy intent.

Medical Policy Group, July 2022 (9): Reviewed by consensus. References added. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Updates to Key Points, Description. No change to policy statement.

Medical Policy Group, August 2023 (9): Reviewed by consensus. Updates to Benefit Application and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy. No change to policy statement.

Medical Policy Group, August 2024 (9): Updates to Key Points, Key Words (Corvis ST), Approved by Governing Bodies, and References. Reviewed by consensus. No new published peer-reviewed literature is available that would alter the coverage statement in this policy. Policy Statement updated to replace “not medically necessary” verbiage with “investigational.” No change to Policy intent.

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.