For services on or after June 18, 2011, see policy S-31.

Photodynamic therapy is a medical procedure which involves the infusion of a photosensitive (light-activated) drug with a very specific absorption peak. This drug is chemically designed to have a unique affinity for the diseased tissue intended for treatment. Once introduced to the body, the drug accumulates and is retained in diseased tissue to a greater degree than in normal tissue. Infusion is followed by the targeted irradiation of this tissue with a non-thermal laser calibrated to emit light at a wavelength that corresponds to the drug's absorption peak. The drug then becomes active and locally treats the diseased tissue.

Photosensitive drugs are the light-sensitive agents used in photodynamic therapy. Once introduced into the body, these drugs selectively identify and adhere to diseased tissue. The drugs remain inactive until they are exposed to a specific wavelength of light, by means of a laser, that corresponds to their absorption peak. The activation of a photosensitive drug results in a photochemical reaction which treats the diseased tissue without affecting surrounding normal tissue.

Verteporfin (Visudyne)

Visudyne is a light-activated drug that was approved by the FDA to slow vision loss in patients with subfoveal choroidal neovascularization (CNV) lesions secondary to exudative (wet) age-related macular degeneration (AMD). AMD is the leading cause of blindness in adults over the age of 50. 90% of AMD is the "dry" form, and 10% accounts for the "wet" form.

Visudyne was more recently FDA approved for the treatment of patients with predominantly classic subfoveal choroidal neovascularization, due to presumed ocular histoplasmosis or pathologic myopia.

"Ocular" Photodynamic Therapy (OPT) is a two-stage process requiring administration of both drug and non-thermal red light. The therapy takes approximately 20 minutes. It begins with the intravenous injection of Visudyne, which travels throughout the body and into the abnormal vessels of the eye. Shining a laser light for about 90 seconds into the patient's eye then activates the drug. Light activation results in local damage to neovascular endothelium, resulting in vessel occlusion.

Ocular Photodynamic Therapy (OPT) is used in the treatment of ophthalmologic diseases. OPT is only covered when used in conjunction with verteporfin.

Classic Subfoveal Choroidal Neovascular (CNV) Lesions

Verteporfin (Visudyne) in combination with ocular photodynamic therapy (OPT) is covered with a diagnosis of neovascular age-related macular degeneration (AMD) with predominately classic subfoveal choroidal neovascular (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. Subsequent follow-up visits will require a fluorescein angiogram prior to treatment. The fluorescein angiogram should be maintained in the patient's medical record and be available upon request.

Subfoveal occult with no classic CNV associated with AMD

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.

Subfoveal minimally classic CNV (where the area of classic CNV occupies <50% of the area of the entire lesion) associated with AMD

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.

Verteporfin in combination with OPT is covered when used as described above for CNV lesions. In addition, coverage is extended to include presumed ocular histoplasmosis and pathologic myopia. As noted above, coverage is indicated when the area of classic CNV occupies > 50% of the area of the entire lesion, as determined by angiogram. The fluorescein angiogram should be maintained in the patient's medical record and be available upon request.

Noncovered Indications

Other uses of OPT with verteporfin to treat AMD not already addressed above 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

OPT is considered not medically necessary when used for conditions other than those listed under the "Indications and Limitations of Coverage and/or Medical Necessity" section of this policy. In addition, OPT is only covered when used with Visudyne. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Documentation Requirements

Medical records must indicate OPT was used in combination with Visudyne for coverage to be considered.

The following documentation must be maintained in the patient’s medical record for services reported with a diagnosis of subfoveal occult with no classic CNV associated with AMD, or subfoveal minimally classic CNV (where the area of classic CNV occupies <50% of the area of the entire lesion) associated with AMD:

• Evidence of progression as documented by deterioration of visual acuity (at least 5 letters on a standard eye examination chart), or
• Lesion growth (an increase in at least 1 disk area), or
• The appearance of blood associated with the lesion

Documentation in the medical record must contain a history and physical pertinent to the indications of this policy. In addition the documentation must support the medical necessity for performing this procedure and be available upon request.

The medical record must contain documentation to substantiate the medical necessity, as well as the frequency of this procedure.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Use procedure code J3396 (for the Visudyne) and codes 67221, 67225, for the ocular photodynamic therapy (OPT). The allowance for code 67221 or 67225 includes the infusion service for the drug, the Kit and the exposure to the laser light. The drug (Visudyne) is separately reimbursable under code J3396.

When submitting a claim for OPT performed on both eyes, report the first eye with code 67221 and the second eye with 67225.

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

Title XVIII of the Social Security Act, section 1862(a)(1)(A) states that no payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

CMS Online Manual Pub. 100-2, Chapter 1, Section 120 and Pub. 100-2, Chapter 16, Section 180 contain information on services performed with non-covered services.

CMS Online Manual Pub. 100-2, Chapter 16, Section 20 is specific to services, which are not considered reasonable and necessary.

CMS Online Manual Pub. 100-3, Chapter 1, Section 80.2.1

CMS Online Manual Pub. 100-3, Chapter 1, Section 80.3.1

Covered Diagnosis Codes