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National Coverage Determination (NCD)

Photodynamic Therapy (OPT)

80.2

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Tracking Information

Publication Number
100-3
Manual Section Number
80.2
Manual Section Title
Photodynamic Therapy (OPT)
Version Number
2
Effective Date of this Version
04/01/2004
Ending Effective Date of this Version
04/03/2013
Implementation Date
04/01/2004
Implementation QR Modifier Date

Description Information

Benefit Category
Physicians' Services


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

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.
Indications and Limitations of Coverage

Ocular photodynamic therapy (OPT)

The OPT is used in the treatment of ophthalmologic diseases. OPT is only covered when used in conjunction with verteporfin (see §80.3, “Photosensitive Drugs”).

  • Classic Subfoveal Choroidal Neovascular (CNV) Lesions - 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 percent 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. There are no requirements regarding visual acuity, lesion size, and number of re-treatments.
  • Occult Subfoveal Choroidal Neovascular (CNV) Lesions - OPT is noncovered for patients with a diagnosis of age-related macular degeneration (AMD) with occult and no classic CNV lesions.
  • Other Conditions - Use of OPT with verteporfin for other types of AMD (e.g., patients with minimally classic CNV lesions, atrophic, or dry AMD) is noncovered. OPT with verteporfin for other ocular indications such as pathologic myopia or presumed ocular histoplasmosis syndrome, is eligible for coverage through individual contractor discretion.
Cross Reference
Also see NCD on Verteporfin §80.3.
Claims Processing Instructions

Transmittal Information

Transmittal Number
9
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R9NCD.pdf
Revision History

4/2004 - Covered for 1) subfoveal occult with no classic CNV associated with AMD; and 2) subfoveal minimally classic CNV (where area of classic CNV occupies <50% of area of entire lesion) associated with AMD, provided certain criteria are met. Effective and implementation dates 04/01/2004. (TN 9) (CR 3191)

8/2002 - Remained noncovered for patients with occult and no classic lesions. Effective and implementation dates 08/20/2002. (TN 157) (CR 2335) 

2/2001 - Covered when used in conjunction with verteporfin for patients with neovascular age-related macular degeneration with predominately classic subfoveal choroidal neovascular lesions (where the area of classic CNV occupies  ≥50% of the area of the entire lesion), as determined by a fluorescein angiogram. Effective and implementation dates 07/01/2001. (TN 135) (CR 1549)
Other

National Coverage Analyses (NCAs)

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Photodynamic Therapy 3 04/03/2013 - N/A View
Photodynamic Therapy (OPT) 2 04/01/2004 - 04/03/2013 You are here
Photodynamic Therapy 1 08/20/2002 - 04/01/2004 View
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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