LCD L34512

Coverage Guidance

Title XVIII of the Social Security Act, §1861(s)(2)(K) addresses services which would be physicians' services if furnished by a physician and which are performed by a physician assistant, nurse practitioner or clinical nurse specialist.

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act, §1862(a)(7) excludes routine physical examinations.

Title XVIII of the Social Security Act, §1862(a)(14) excludes payment for services, which are other than physicians’ services, certified nurse-midwife services, qualified psychologist services, and services of a certified registered nurse anesthetist, and which are furnished to an individual who is a patient of a hospital or critical access hospital by an entity other than the hospital or critical access hospital, unless the services are furnished under arrangements with the entity made by the hospital or critical access hospital.

42 Code of Federal Regulations (CFR) §410.74 Physician assistants' services

42 Code of Federal Regulations (CFR) §410.75 Nurse practitioners' services

42 Code of Federal Regulations (CFR) §410.76 Clinical nurse specialists' services

42 Code of Federal Regulations (CFR) §419.22 Hospital services excluded from payment under the hospital outpatient prospective payment system

Indications and Limitations of Coverage

Abstract:

Corneal pachymetry is the measurement of corneal thickness and commonly uses either ultrasonic or optical methods. Measurement of corneal thickness in individuals presenting with increased intraocular pressure assists in determining if there is a risk of glaucoma, or if the individual's increased eye pressure is the result of abnormal corneal thickness. The test must be integral to the medical management decision-making of the patient. Coverage is limited to ophthalmologists and optometrists.

Indications and Limitations:

Medicare will consider corneal pachymetry to be medically necessary and reasonable, when performed to determine:

• The amount of endothelial trauma sustained during surgery involving the cornea

• Preoperative assessment of the health of the cornea in Fuch's dystrophy

• Assessment of corneal thickness after ocular trauma

• Assessment of corneal thickness in suspected glaucoma following the diagnosis of increased intraocular pressure AND prior to the initiation of a treatment regimen for glaucoma

It is expected that a service for a corneal thickness measurement following the diagnosis of increased intraocular pressure will be performed once in a lifetime per beneficiary, unless there has been interval corneal trauma or surgery following a previous measurement. The lifetime limit ONLY applies for measurements done to assess corneal thickness, in conjunction with a glaucoma diagnosis. The limit does not apply in cases where the assessment of corneal thickness is required after ocular trauma (surgical or accidental) has been sustained, including the management of bullous keratopathy resulting from surgical or accidental trauma, or in Fuch’s dystrophy.

Medicare will consider corneal pachymetry to be medically necessary and reasonable when performed only by ophthalmologists and optometrists.

Medicare will not pay for use of pachymetry when used in preparation for surgery to reshape the cornea of the eye for the purpose of correcting visual problems (refractive surgery), such as myopia (nearsightedness) and hyperopia (farsightedness). When the change in the corneal shape results from a previous partial or complete corneal transplant, Medicare will cover a pachymetry service.

Whether patients have been previously diagnosed and are under treatment for glaucoma or are newly diagnosed, pachymetry will be covered once per lifetime per beneficiary, or more frequently in cases where there has been surgical or non-surgical trauma.

Other Comments:

Limitation of liability and refund requirements apply when denials are likely, whether based on medical necessity or other coverage reasons. The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item or procedure may not be covered by Medicare. The limitation of liability and refund requirements do not apply when the test, item or procedure is statutorily excluded, has no Medicare benefit category, or is rendered for screening purposes.

For outpatient settings, other than Comprehensive Outpatient Rehabilitation Facilities (CORFs), references to "physicians" throughout this policy include non-physicians, such as nurse practitioners, clinical nurse specialists and physician assistants. Such non-physician practitioners, with certain exceptions, may certify, order and establish the plan of care as authorized by State law.

Summary of Evidence

N/A

Analysis of Evidence

N/A

Associated Information

Documentation Requirements

Medical record documentation maintained by the ordering/referring physician must indicate the medical necessity for performing the test and the test results. In addition, if the service exceeds the frequency parameter listed in this policy, documentation of medical necessity must be submitted. This information is usually found in the history and physical, office/progress notes, or test results.

If the provider of the service is other than the ordering/referring physician, that provider must maintain hard copy documentation of test results and interpretation, along with copies of the ordering/referring physician's order for the studies. The physician must state the clinical indication/medical necessity for the study in the order for the test.

Documentation should contain a history and physical, which supports the diagnosis for which this service is being rendered. Documentation must be legible, relevant and sufficient to justify the services billed. This documentation must be made available to the A/B MAC upon request.

Utilization Guidelines

Palmetto GBA expects these services to be performed, as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

Palmetto GBA expects that the services for the measurement of corneal thickness, in conjunction with a glaucoma diagnosis, will be performed once in a lifetime, unless there has been interval corneal trauma (surgical or accidental), including the management of bullous keratopathy resulting from surgical or accidental trauma, or in Fuch’s dystrophy.

Bibliography

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Chen PP, Kim JW. Central corneal pachymetry and visual field progression in patients with open-angle glaucoma. Ophthalmology. 2004;111(11):2126-32.

Gordon MO, Beiser JA, Brandt JD, et al. The ocular hypertension treatment study: Baseline factors that predict the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002; 120(6):714-20.

Herndon LW, Stinnett SS, Weizer JS. Central corneal thickness as a risk factor for advanced glaucoma damage. Arch Ophthalmol. 2004;122(1):17-21.

Ho T, Cheng AC, Rao SK, Lau S, Leung CK, Lam DS. Central corneal thickness measurements using Orbscan II, Visante, ultrasound, and pentacam pachymetry after laser in situ keratomileusis for myopia. J Cataract Refract Surg. 2007;33(7):1177-82.

Kass MA, Heuer DK, Higginbotham EJ, et al. The ocular hypertension treatment study: A randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002;120(6):701-13.

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Lleo A, Marcos A, Alonso L, Calatayud M, Rahhal SM, Sanchis-Gimeno JA. The relationship between central corneal thickness and Goldmann applanation tonometry. Clin Exp Optom. 2003;86(2):104-8.

Medeiros FA, Sample PA, Zangwill LM, Bowd C, Aihara M, Weinreb RN. Corneal thickness as a risk factor for visual field loss in patients with preperimetric glaucomatous optic neuropathy. Am J Ophthalmology. 2003;136(5):805-813.

Nemesure B, Wu SY, Hennis A, Leske MC, Barbados Eye Study Group. Corneal thickness and intraocular pressure in the Barbados eye studies. Arch Ophthalmol. 2003;121(2):240-244.

Palmberg P. Answers from the ocular hypertension treatment study. Arch Opthalmol. 2002;120(6):829-30.

Shih CY, Trokel SL, Tsai JC, Graff Zivin JS. Clinical significance of central corneal thickness in the management of glaucoma. Arch Ophthalmol. 2004;122(9):1270-5.

Ventura AC, Bohnke M, Mojon DS. Central corneal thickness measurements in patients with normal tension glaucoma, primary open angle glaucoma, pseudoexfoliation glaucoma, or ocular hypertension. Br J Ophthalmology. 2001;85(7):792-5.

Wang J, Fonn D, Simpson TL, Jones L. Relation between optical coherence tomography and optical pachymetry measurements of corneal swelling induced by hypoxia. Am J Ophthalmology. 2002;134(1):93-8.