LCD L34175

Coverage Guidance

Language quoted from Centers for Medicare and Medicaid Services (CMS). National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Section 1862(a) (7) excludes routine physical examination unless otherwise covered by statute.

Code of Federal Regulations:

42 CFR Section 410.32 indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements).

Indications and Limitations of Coverage

Abstract:

Fluorescein

Fluorescein angiography is used in the diagnosis and treatment of a wide range of ocular disorders. Its visible fluorescence on leaking from damaged vessels makes it particularly useful in the diagnosis of retinal vascular disorders and monitoring treatment of conditions amenable to laser photocoagulation.

The dye is injected intravenously and serial photographs are taken through the pupil. While morphological characteristics alone may be pathognomonic of certain disease states, the timing of appearance of the dye in the choroid, in the central retinal artery and in the filling (or otherwise) of the quadrants have diagnostic implications.

Indocyanine Green

Indocyanine green dye is injected intravenously into the patient to highlight the vessels in the retina and the deeper tissue layer of the choroid. Under infrared light, Indocyanine Green fluoresces allowing the choroidal vessels to be visualized through the retinal pigment epithelium or in the presence of retinal or vitreous hemorrhage that would otherwise obscure visualization. Indocyanine green angiography (ICG) is effective in the diagnosis and treatment of ill-defined choroidal neovascularization (e.g., associated with age related macular degeneration). It is also useful in the evalution of feeder vessels, choroidal leakages in the late phase, and ruptures of the pigment epithelium.

Indications:

Fluorescein

Fluorescein angiography with interpretation is medically necessary as an adjunct to the diagnosis of chorioretinal vascular abnormalities especially relating to choroid neovascularization, noninfective vasculitis, and age related macular degeneration. It may also be appropriate in evaluating intraocular tumors, visual loss in systemic disease, acute exudative inflammations such as toxoplasmosis and optic disc edema. Medical necessity for such angiography would generally be in the context of a changing clinical picture. Fluorescein angiography may be useful in diabetic retinopathy in identifying ischemia and neovascularization, locating microaneurysms, and defining macular edema.

Fluorescein angiography following treatment, for example, of choroidal neovascularization (CNV) is necessary to monitor for recurrence or to detect additional treatable disease. Usually this is performed on the basis of a change in the clinical picture similar to the way it is employed prior to treatment. However, fluorescein angiography may be performed following treatment without clinical change in order to detect occult lesions. This will occur most often in CNV and very rarely in other diseases.

Indocyanine Green

Indocyanine green angiography (ICG) may be a valuable diagnostic adjunct to fluorescein angiography in the evaluation of the following conditions:

• Retinal neovascularization

• Choroid neovascularization

• Serous detachment of retinal pigment epithelium

• Hemorrhagic detachment of retinal pigment epithelium

• Retinal hemorrhage

Limitations:

Fluorescein

Studies performed for screening will be denied by Medicare as not medically necessary.

Fluorescein angiography must be performed under the direct supervision (physician present in the office and immediately available) of a physician when done by a non-physician practitioner.

If excluded by State law, optometrists may not be reimbursed for fluorescein angiography.

Fluorescein angiography of an asymptomatic contralateral eye without new abnormalities on ophthalmoscopic exam, in patients with unilateral Age related Macular Degeneration (AMD) or other disease, will be denied as not medically necessary. Evidence of medical necessity must be documented in the medical record for each eye.

Indocyanine Green

Indocyanine green angiography must be performed under the direct supervision (physician present in the office and immediately available) of a physician when done by a non-physician practitioner.

If excluded by State law, optometrists may not be reimbursed for ICG angiography.

Indocyanine green is formulated with iodine and should not be used on patients who are allergic to iodine.

ICG for the evaluation of patients with background diabetic retinopathy is not considered to be a medically necessary service.

ICG angiography of an asymptomatic contralateral eye without new abnormalities on ophthalmoscopic exam, in patients with unilateral AMD or other disease, will be denied as not medically necessary. Evidence of medical necessity must be documented in the medical record for each eye.

Studies performed for screening will be denied by Medicare as not medically necessary.

Summary of Evidence

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Analysis of Evidence

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Bibliography

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