CMS Verteporfin (OPT) Coverage Policy Updated: What Billing Teams Need to Know in 2026
CMS has modified National Coverage Determination (NCD) 350, which governs coverage of verteporfin used in ocular photodynamic therapy (OPT) for Medicare patients. This update, effective March 12, 2026, refines the medical necessity framework for one of ophthalmology's more documentation-intensive treatments — and billing teams need to confirm their documentation workflows align with CMS's current criteria before claims go out the door.
| Field | Detail |
|---|---|
| Payer | CMS (Centers for Medicare & Medicaid Services) |
| Policy | Verteporfin |
| Policy Code | NCD 350 |
| Change Type | Modified |
| Effective Date | 2026-03-12 |
| Impact Level | Medium |
| Specialties Affected | Ophthalmology, Retina Surgery, Ocular Oncology |
| Key Action | Audit active verteporfin cases to confirm lesion characterization and progression documentation meet current CMS medical necessity criteria before billing. |
What CMS NCD 350 Covers: Verteporfin and Ocular Photodynamic Therapy
Verteporfin is a benzoporphyrin derivative administered intravenously as a photosensitive drug. It's used exclusively in conjunction with ocular photodynamic therapy (OPT) — a laser-based treatment that activates the drug after IV administration to target abnormal choroidal blood vessels. The Centers for Medicare & Medicaid Services first established coverage for this treatment in 2004 under NCD 350, and this 2026 modification updates and restates the applicable indications, restrictions, and documentation requirements.
One critical administrative note: verteporfin is covered only when furnished intravenously incident to a physician's service. This has direct implications for how the drug and the associated OPT procedure are billed — both must be clearly documented as part of a physician-supervised encounter.
CMS-Covered Indications for Verteporfin OPT Under NCD 350
CMS covers OPT with verteporfin specifically for patients diagnosed with neovascular (wet) age-related macular degeneration (AMD). Coverage is not blanket — it hinges on the precise characterization of the choroidal neovascularization (CNV) lesion identified on imaging.
Predominantly Classic Subfoveal CNV
The first covered indication is predominantly classic subfoveal CNV, defined as lesions where the classic CNV component occupies 50% or more of the total lesion area, as determined by fluorescein angiogram (FA) at the initial visit. For follow-up visits, CMS accepts either an FA (effective April 1, 2004) or optical coherence tomography (effective April 3, 2013) to assess treatment response.
For this indication, there are no CMS requirements regarding visual acuity level, lesion size, or number of retreatments. That flexibility is meaningful for high-volume retina practices — but the lesion classification must still be clearly documented.
Subfoveal Occult with No Classic CNV
CMS covers OPT with verteporfin for subfoveal occult CNV with no classic component associated with AMD. However, this indication carries additional medical necessity criteria (see below).
Subfoveal Minimally Classic CNV
The third covered indication is minimally classic subfoveal CNV — where the classic CNV component occupies less than 50% of the total lesion area. Like the occult-only indication, this one is subject to the size and progression criteria outlined below.
Medical Necessity Criteria for Occult-Only and Minimally Classic Lesions
For the occult-only and minimally classic CNV indications, CMS deems treatment reasonable and necessary only when both of the following conditions are met:
1. Lesion size at initial treatment:
The lesion must be 4 disk areas or less in size at the time of initial treatment, or within the three months prior to initial treatment.
2. Evidence of progression within 3 months prior to initial treatment:
Progression must be documented by at least one of the following:
| # | Covered Indication |
|---|---|
| 1 | Deterioration of visual acuity — a loss of at least five letters on a standard eye examination chart |
| 2 | Lesion growth — an increase of at least one disk area |
| 3 | Appearance of blood associated with the lesion |
These criteria require that your clinical documentation be specific, timestamped, and tied directly to the FA or OCT findings on record. Vague notes referencing "worsening vision" without the quantified letter loss won't satisfy CMS's threshold.
Non-Covered Indications: What CMS Explicitly Excludes
NCD 350 is equally clear about what OPT with verteporfin does not cover under Medicare. Billing staff should flag these scenarios before claims are submitted:
- Juxtafoveal or extrafoveal CNV lesions — lesions located outside the fovea are non-covered regardless of lesion type or size
- Cases where fluorescein angiography cannot be obtained — inability to perform an FA removes the diagnostic foundation for coverage
- Atrophic ("dry") AMD — verteporfin OPT is not covered for the dry form of AMD
- Any other AMD indications not already addressed by CMS — non-covered by default
For other ocular indications — pathologic myopia or presumed ocular histoplasmosis syndrome — coverage is not nationally determined. These fall under local coverage determination (LCD) authority, meaning individual Medicare Administrative Contractors (MACs) have discretion to cover or deny these uses in their jurisdiction. Practices billing for these indications should confirm the applicable MAC's LCD before proceeding.
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
Affected Codes
The official NCD 350 policy document does not list specific CPT or HCPCS codes. Billing teams should confirm the applicable procedure and drug codes with their MAC or refer to the CMS Claims Processing Transmittal referenced in the policy (TN 2728).
Related ICD-10 Diagnosis Codes to Monitor
While NCD 350 does not enumerate specific ICD-10-CM codes, the covered indications map to AMD and CNV diagnoses. Work with your coding team to ensure ICD-10-CM codes accurately reflect lesion subtype (classic, minimally classic, occult) and lesion location (subfoveal), as these distinctions directly determine whether a claim will be covered or denied under this NCD.
What Your Billing Team Should Do
| # | Action Item |
|---|---|
| 1 | Audit documentation for active verteporfin cases (within 30 days). Pull any claims in the queue for OPT with verteporfin and confirm that each claim's supporting documentation includes lesion characterization by FA, lesion size in disk areas, and — for occult or minimally classic lesions — documented evidence of progression within the prior three months. |
| 2 | Verify MAC-level LCD guidance for non-AMD indications. If your practice treats pathologic myopia or presumed ocular histoplasmosis with OPT, contact your MAC directly or search your MAC's LCD database to confirm current local coverage status before billing Medicare. |
| 3 | Update follow-up visit documentation templates. Ensure that post-treatment progress notes specify whether OCT or FA was used to assess treatment response, and that the choice aligns with CMS's accepted documentation timeline (OCT accepted effective April 3, 2013; FA accepted effective April 1, 2004). |
| 4 | Train clinical documentation staff on the progression criteria thresholds. The five-letter visual acuity loss and one disk area growth thresholds are specific — clinicians and scribes should know these numbers and document them explicitly rather than using qualitative language. |
| 5 | Confirm "incident to" billing compliance. Since verteporfin must be administered intravenously incident to a physician's service, verify that all claims reflect appropriate physician supervision and that the billing structure — including any drug administration codes — correctly reflects that relationship. |
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