CMS Pub. 100-03, ch. 1, § 80.2.1

A. General

Ocular Photodynamic Therapy (OPT) is used in the treatment of ophthalmologic

diseases; specifically, for age-related macular degeneration (AMD), a common eye

disease among the elderly. OPT involves the infusion of an intravenous photosensitizing

drug called verteporfin followed by exposure to a laser. OPT is only covered when used

in conjunction with verteporfin.

Effective July 1, 2001, OPT with verteporfin was approved for a diagnosis of neovascular

AMD with predominately classic subfoveal choroidal neovascularization (CNV) lesions

(where the area of classic CNV occupies ≥50% of the area of the entire lesion) at the

initial visit as determined by a fluorescein angiogram (FA).

On October 17, 2001, the Centers for Medicare & Medicaid Services (CMS) announced

its “intent to cover” OPT with verteporfin for AMD patients with occult and no classic

subfoveal CNV as determined by an FA. The October 17, 2001, decision was never

implemented.

On March 28, 2002, after thorough review and reconsideration of the October 17, 2001,

intent to cover policy, CMS determined that the current non-coverage policy for OPT for

verteporfin for AMD patients with occult and no classic subfoveal CNV as determined by

an FA should remain in effect.

Effective August 20, 2002, CMS issued a non-coverage instruction for OPT with

verteporfin for AMD patients with occult and no classic subfoveal CNV as determined by

an FA.

B. Nationally Covered Indications

Effective April 1, 2004, OPT with verteporfin continues to be approved for a diagnosis of

neovascular AMD with predominately classic subfoveal CNV lesions (where the area of

classic CNV occupies ≥50% of the area of the entire lesion) at the initial visit as

determined by an FA. (CNV lesions are comprised of classic and/or occult components.)

Subsequent follow-up visits require either an optical coherence tomography (OCT)

(effective April 3. 2013) or an FA (effective April 1, 2004) to access treatment response.

There are no requirements regarding visual acuity, lesion size, and number of retreatments when treating predominantly classic lesions.

In addition, after thorough review and reconsideration of the August 20, 2002, non-coverage policy, CMS determines that the evidence is adequate to conclude that OPT

with verteporfin is reasonable and necessary for treating:

1. Subfoveal occult with no classic CNV associated with AMD; and,

2. Subfoveal minimally classic CNV (where the area of classic CNV occupies <50%

of the area of the entire lesion) associated with AMD.

The above 2 indications are considered reasonable and necessary only when:

1. The lesions are small (4 disk areas or less in size) at the time of initial treatment

or within the 3 months prior to initial treatment; and,

2. The lesions have shown evidence of progression within the 3 months prior to

initial treatment. Evidence of progression must be documented by deterioration of

visual acuity (at least 5 letters on a standard eye examination chart), lesion growth

(an increase in at least 1 disk area), or the appearance of blood associated with the

lesion.

C. Nationally Non-Covered Indications

Other uses of OPT with verteporfin to treat AMD not already addressed by CMS will

continue to be non-covered. These include, but are not limited to, the following AMD

indications:

• Juxtafoveal or extrafoveal CNV lesions (lesions outside the fovea),

• Inability to obtain a fluorescein angiogram,

• Atrophic or “dry” AMD.

D. Other

The OPT with verteporfin for other ocular indications, such as pathologic myopia or

presumed ocular histoplasmosis syndrome, continue to be eligible for local coverage

determinations through individual A/B MAC discretion.