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National Coverage Determination (NCD)

Verteporfin

80.3.1

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Tracking Information

Publication Number
100-3
Manual Section Number
80.3.1
Manual Section Title
Verteporfin
Version Number
1
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
Drugs and Biologicals


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

Item/Service Description

General

Verteporfin, a benzoporphyrin derivative, is an intravenous lipophilic photosensitive drug with an absorption peak of 690 nm. Verteporfin was first approved by the Food and Drug Administration on April 12, 2000, and subsequently approved for inclusion in the United States Pharmacopoeia on July 18, 2000, meeting Medicare’s definition of a drug as defined under §1861(t)(1) of the Social Security Act. Verteporfin is only covered when used in conjunction with ocular photodynamic therapy OPT) when furnished intravenously incident to a physician’s service.
Indications and Limitations of Coverage

Covered Indications

Effective April 1, 2004, OPT with verteporfin is covered for patients with a diagnosis of neovascular age-related macular degeneration (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. (CNV lesions are comprised of classic and/or occult components.) Subsequent follow-up visits require a fluorescein angiogram prior to treatment.

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

  • Subfoveal occult with no classic associated with AMD.
  • Subfoveal minimally classic CNV 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.

Noncovered Indications

Other uses of OPT with verteporfin to treat AMD not already addressed by CMS will continue to be noncovered. 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, or atrophic or “dry” AMD.

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 contractor discretion.

(This NCD last reviewed March 2004.)
Cross Reference
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

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

02/2001 - Included verteporfin for use in OPT for patients with neovascular AMD with predominately classic subfoveal CNV lesions (where the area of classic CNV occupies = 50% of area of entire lesion), as determined by a fluorescein angiogram. Effective and implementation dates 07/01/2001. (TN 135) (CR 1549)

08/2002 - Provided that Verteporfin when used with OPT for treatment of patients with AMD with occult and no classic lesions remained noncovered. Effective and implementation dates 08/20/2002. (TN 157) (CR 2335)

11/2002 - Deleted code reference for photosensitive drugs because it belongs in claims processing instructions. Effective and implementation dates 01/01/2003. (TN 162) (CR 2438)
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
Verteporfin 2 04/03/2013 - N/A View
Verteporfin 1 04/01/2004 - 04/03/2013 You are here
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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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