NCD 80.3.1: Verteporfin

A. 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.

B. Nationally 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 (FA). (CNV lesions are comprised of classic and/or occult components.) Subsequent follow-up visits require either an optical coherence tomography (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.

• Subfoveal occult with no classic CNV associated with AMD.

• Subfoveal minimally classic CNV (where the area of classic CNV occupies The above 2 indications are considered reasonable and necessary only when:

• 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,

• 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 the Centers for Medicare & Medicaid Services 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 an FA, or 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 Medicare Administrative Contractor discretion.

03/2025 - The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations (NCDs). No policy is being changed as a result of these updates. ( TN 13097 ) (CR13939)

10/2024 - The purpose of the Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations(NCDs). No policy is being changed as a result of these updates. ( TN 12903 ) (CR13818)

01/2018 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html , along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. ( TN 2005 ) (CR10318)

11/2017 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. ( TN 1975 ) (CR10318)

05/2017 - This change request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html , along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. ( TN 1854 ) (CR10086)

02/2017 - This change request (CR) is the 10th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates as follows: CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, CR9540, CR9631, and CR9751, as well as in CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. ( TN 1792 ) (CR9861)

12/2015 - This change request (CR) is the 3rd maintenance update of ICD-10 conversions/updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, & CR9087. Some are the result of revisions required to other NCD-related CRs released separately that included ICD-10 coding. Implementation date: 01/04/2016 Effective date: 10/1/2015. ( TN 1580 ) (CR9252)

08/2015 - This change request (CR) is the 3rd maintenance update of ICD-10 conversions/updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, & CR9087. Some are the result of revisions required to other NCD-related CRs released separately that included ICD-10 coding.

These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 01/04/2016 Effective date: 10/1/2015. ( TN 1537 ) (CR 9252)

05/2014 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 10/06/2014 Effective date: 10/1/2015. ( TN 1388 ) ( TN 1388 ) (CR 8691)

09/2012 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 01/07/2013 Effective date: 10/1/2015. ( TN 1122 ) ( TN 1122 ) (CR 7818)

06/2013 - Effective for claims with dates of service on and after April 3, 2013, CMS expanded coverage of ocular photodynamic therapy (OPT) with verteporfin for "wet" age-related macular degeneration (AMD). CMS revised the requirements for testing to permit either optical coherence tomography (OCT) or fluorescein angiography (FA) to assess treatment response. Corresponding changes are referenced in NCDs: 80.2 - Photodynamic Therapy, 80.2.1 - Ocular Photodynamic Therapy (OPT), and 80.3 - Photosensitive Drugs. Effective date: 04/03/2013 and implementation date: 07/16/2013. ( TN 155 ) (CR 8292)

04/2004 - Covered for subfoveal occult with no classic CNV associated with AMD; and subfoveal minimally classic CNV (where area of classic CNV occupies TN 9 ) (CR 3191)

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)

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)

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)