LCD L34426

Coverage Guidance

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)(14) defines other than physician services.

Title XVIII of the Social Security Act, §1862(a)(7) states Medicare will not cover any services or procedures associated with routine physical exams.

42 CFR §410.32(a) 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).

42 CFR §410.74 defines physician assistants' services.

42 CFR §410.75 defines nurse practitioners' services.

42 CFR §410.76 defines clinical nurse specialists' services.

CMS Internet-Only Manual, Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 1, §80.2 Photodynamic Therapy, §80.2.1 Ocular Photodynamic Therapy (OPT) - Effective April 3, 2013, §80.3 Photosensitive Drugs and §80.3 Verteporfin - Effective April 3, 2013

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 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 (ICG) 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, ICG 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. ICG is effective in the diagnosis and treatment of ill-defined choroidal neovascularization (e.g., associated with age related macular degeneration (AMD). It is also useful in the evaluation 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 AMD. 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

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 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

ICG 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.

ICG 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.

Other Comments:

Limitation of liability and refund requirements apply when denials are based on medical necessity. 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 considered medically necessary 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. (See Section CMS National Coverage Policy).

Summary of Evidence

N/A

Analysis of Evidence

N/A

Associated Information

Documentation Requirements

The patient's medical record must contain documentation that fully supports the medical necessity for fluorescein and ICG angiography as it is covered by Medicare. (See Coverage Indications, Limitations, and/or Medical Necessity). This documentation includes, but is not limited to, relevant medical history, physical examination and results of pertinent diagnostic tests or procedures.

Copies of fluorescein and ICG angiograms (photographic or digital) must be retained in the patient's medical records. An interpretation and report of the test must also be included, in addition to the photographs themselves.

The medical record should include documentation of 1 of the following when ICG angiography is performed:

• Evidence of ill-defined subretinal neovascular membrane or suspicious membrane on previous fluorescein angiography

• Retinal pigment epithelium (RPE) does not show subretinal neovascular membrane on current fluorescein angiography

• Presence of subretinal hemorrhage or hemorrhagic RPE. A fluorescein angiography need not have been done previously.

Evidence of medical necessity must be documented in the medical record for each eye.

Documentation, including photos, supporting the medical necessity should be legible, maintained in the patient's medical record, and must be made available to the A/B MAC upon request.

Utilization Guidelines

Fluorescein angiography is considered medically necessary no more than 9 times per eye in 365 days. Claims exceeding this frequency will be suspended and reviewed for medical necessity.

ICG angiography is considered medically necessary no more than 9 times per eye in 365 days. Claims exceeding this frequency will be suspended and reviewed for medical necessity.

Fluorescein angiography performed within 30 days of ICG angiography will be denied as not medically necessary, unless there is documentation in the patient's medical record of co-existing diseases, such as AMD or diabetes.

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