Summary Of Evidence

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Analysis of Evidence

N/A

Abstract:

Glaucoma is a leading cause of blindness, and a disease for which treatment methods clearly are available and in common use. Glaucoma also is diagnostically challenging. Almost 50% of glaucoma cases remain undetected. Elevated intraocular pressure is a clear risk factor for glaucoma, but over 30% of those suffering from the disease have pressures in the normal range. Further, most patients having abnormally high pressures will never suffer glaucomatous damage to their vision. Scanning computerized ophthalmic diagnostic imaging (SCODI) allows for early detection of glaucomatous damage to the nerve fiber layer or optic nerve of the eye. It is the goal of these diagnostic imaging tests to discriminate among patients with normal intraocular pressures (IOP) who have glaucoma, patients with elevated IOP who have glaucoma, and patients with elevated IOP who do not have glaucoma. These tests can also provide precise methods of observation of the optic nerve head and can more accurately reveal subtle glaucomatous changes over the course of follow-up exams than visual field and/or disc photos. This can allow earlier and more efficient treatment of the disease process.

Retinal disorders are the most common causes of severe and permanent vision loss. Scanning computerized ophthalmic diagnostic imaging (SCODI) is a valuable tool for the evaluation and treatment of patients with retinal disease, especially macular abnormalities. SCODI is able to detail the microscopic anatomy of the retina and the vitreo-retinal interface. SCODI is useful to measure the effectiveness of therapy, and in determining the need for ongoing therapy, or the safety of cessation of that therapy.

Many forms of scanning computerized ophthalmic diagnostic imaging tests currently exist (e.g., confocal laser scanning ophthalmoscopy [topography], scanning laser polarimetry, optical coherence tomography [OCT], and retinal thickness analysis). Although these techniques are different, their objective is the same. Medicare will consider scanning computerized ophthalmic diagnostic imaging (SCODI) medically reasonable and necessary in evaluating retinal disorders and glaucoma as documented in this local coverage determination (LCD).

Indications and Limitations:

Glaucoma

Glaucoma commonly causes a spectrum of related eye and vision changes, including erosion of the optic nerve and the associated retinal nerve fibers, and also loss of peripheral vision. A diagnosis of glaucoma seldom is made on the basis of a single clinical observation, but instead relies upon analysis of an assemblage of clinical data, including: optic nerve, retinal nerve fiber, and anterior chamber structure, as well as looking for hemorrhages of the optic nerve, pigment in the anterior chamber, and, especially visual field loss. Each of these methods has its own strengths and limitations, and none is immune to error thus the dependence upon multiple observations. Careful reliance upon all available clinical data can allow early treatment and can prevent unnecessary end-stage therapies.

SCODI allows earlier detection of those patients with normal tension glaucoma and more sophisticated analysis for ongoing management. This technology can distinguish patients with glaucomatous damage irrespective of the status of intraocular pressure. It may separate patients with elevated intraocular pressure and early glaucoma damage from those without glaucoma. This allows early treatment of the disease, preventing unnecessary medical or surgical therapy.

The following codes would generally not be necessary with SCODI. When needed the same day, documentation must justify the procedures.

• 92250 - Fundus photography with interpretation and report
• 92225 - Ophthalmoscopy, extended with retinal drawing (e.g., for retinal detachment, melanoma) with interpretation and report; initial
• 92226 - Subsequent ophthalmoscopy
• 76512 - B-scan (with or without superimposed non-quantitative A-scan)

Scanning computerized ophthalmic diagnostic imaging is not considered medically reasonable and necessary when performed to provide additional confirmatory information regarding a diagnosis or treatment which has already been determined. However, the physician is not precluded from performing one of the listed procedures on the same eye of the patient on the same day, when each is necessary to evaluate and treat the patient. The reason for SCODI in addition to one of the above procedures must be clearly stated in the record.

Glaucoma may be diagnosed as mild, moderate, or severe and SCODI can be utilized as documented below.

Glaucoma Suspect or Mild Damage

SCODI can be used to follow pre-glaucoma patients or those with “mild” damage and who would demonstrate any or all of the following:

Visual Field

• no detectable VF defect;
• "mild" generalized reduction in retinal sensitivity;
• "mild" constriction of isopters;
• nasal step peripheral to 20 degrees; and/or
• small relative defects of the Bjerrum area, peripheral to 9 degrees.

Optic Nerve

• symmetric or vertically elongated cup enlargement; neural rim intact, rim: disc ratio> 0.2; cup:disc ratio <0.8;
• focal notch; rim:disc ratio > 0.2; cup:disc ratio <0.8
• no definite pathologic cupping; and/or
• previously observed disc hemorrhage.

Moderate Glaucomatous Damage

In patients with moderate glaucomatous damage, alternating the use of SCODI and visual field tests within correct time intervals will be considered appropriate, and may increase the sensitivity of detecting glaucomatous damage. Performance of SCODI and visual field tests on the same day, or separated by a short period of time (within three [3] months) is usually not considered medically necessary. However, there may be instances in which each test is needed to determine the patient's status and thus, treatment. The contractor expects use of both tests on the same day or during short intervals will be the exception rather than the rule.

Examples in which each test could be medically necessary include situations in which the clinical examination suggests progression of the glaucoma, yet the visual fields do not show new deficits. SCODI could be used to determine whether there is a change in the nerve fiber loss. Similarly, if the clinical examination showed progression and SCODI was unchanged, the visual field testing might be medically necessary to ascertain whether there is a functional loss of vision. If each test is performed on the same day or within short intervals, the medically necessary rationale must be present in the medical record.

Patients with moderate glaucomatous damage would demonstrate any or all of the following:

Visual Field

• "moderate" generalized reduction in retinal sensitivity;
• "moderate" constriction of isopters absolute defects to within 9 degrees of fixation; and/or
• temporal wedge.

Optic Nerve

• enlarged optic nerve cup with neural rim remaining but sloped or pale;
• focal notches with rim:disc ratio> 0.1 but <0.2; cup:disc ratio > 0.8 but <0.9; and/or
• prominent lamina cribrosa.

Advanced Glaucomatous Damage

Scanning computerized ophthalmic diagnostic imaging is not considered medically reasonable and necessary for patients with “advanced” glaucomatous damage. Instead, visual field testing should be performed. (Late in the course of glaucoma, when the nerve fiber layer has been extensively damaged, visual fields are more likely to detect small changes than scanning computerized ophthalmic diagnostic imaging). Patients with “advanced” glaucomatous damage would demonstrate any or all of the following:

Visual Field

• "severe" generalized reduction in retinal sensitivity;
• "severe" constriction of isopters (i.e., 14e
• absolute defects to within 3 degrees of fixation;
• loss of central acuity; and/or
• temporal island remains.

Optic Nerve

• diffuse enlargement of optic nerve cup; rim:disc ratio<0.1; cup:disc ratio > 0.9; and/or
• wipe out of all or a portion of the neuroretinal rim.

Retinal Disorders

Retinal disorders are the most common causes of severe and permanent vision loss. Scanning computerized ophthalmic diagnostic imaging (SCODI) is a valuable tool for the evaluation and treatment of patients with retinal disease, especially macular abnormalities. SCODI is able to detail the microscopic anatomy of the retina and the vitreo-retinal interface. SCODI is useful to measure the effectiveness of therapy, and in determining the need for ongoing therapy, or the safety of cessation of that therapy. SCODI is useful in evaluating retinal disorders and glaucoma.

Retinal thickness analysis is a non-invasive and non-contact imaging technique that takes direct cross-sectional images of the retina. These high resolution images capture ocular structures and provide data to create thickness maps of the retina. Retinal thickness is directly correlated to ocular disease, including retinal disorders and glaucoma.

In contrast, Scanning Laser Polarimetry is not an appropriate diagnostic technique for the management of retinal disorders. 

Long Term Use of Chlorquine (CQ) and or Hydroxychloroquine (HCQ)

Clinical evidence has shown that long-term use of chloroquine (CQ) and/or hydroxychloroquine (HCQ) can lead to irreversible retinal toxicity. Therefore, these two medications are deemed high risk, and scanning optical coherence tomography may be indicated to provide a baseline prior to starting the medication and as an annual follow-up. Clinical evidence shows that the resolution of time domain OCT instruments is not sufficient to detect early toxic retinal changes. Because of that, spectral domain-optical coherence tomography (SD-OCT) is expected to be used to detect retinal changes that are due to the use of CQ or HCQ.

Other Comments:

For claims submitted to the Part A MAC: this coverage determination also applies within states outside the primary geographic jurisdiction with facilities that have nominated CGS Administrators, LL to process their claims.

Bill type codes only apply to providers who bill these services to the Part A MAC. Bill type codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC.

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 dates of service on or after April 1, 2010, bill type 77X should be used to report FQHC services.