Verteporfin — NCD 350 | CMS Coverage Update

TL;DR: The Centers for Medicare & Medicaid Services modified NCD 350 governing verteporfin coverage, with an effective date of January 9, 2026. Here's what billing teams need to know before submitting claims.

CMS verteporfin coverage policy under NCD 350 Medicare has been updated. This policy covers ocular photodynamic therapy (OPT) with verteporfin for neovascular age-related macular degeneration (AMD). The policy does not list specific CPT or HCPCS codes, but verteporfin billing teams at ophthalmology and retina practices need to understand the updated medical necessity criteria before claims go out.

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Quick-Reference Table

Field	Detail Copy
Payer	CMS (Centers for Medicare & Medicaid Services)
Policy	Verteporfin — NCD 350 | CMS Coverage Update
Policy Code	NCD 350
Change Type	Modified
Effective Date	January 9, 2026
Impact Level	Medium
Specialties Affected	Ophthalmology, Retina Specialists, Ocular Oncology
Key Action	Audit your documentation protocols for CNV lesion classification and progression evidence before submitting verteporfin claims

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CMS Verteporfin Coverage Criteria and Medical Necessity Requirements 2026

NCD 350 is the National Coverage Determination governing Medicare coverage of verteporfin used in ocular photodynamic therapy (OPT). Verteporfin is a benzoporphyrin derivative administered intravenously. It is a photosensitive drug with an absorption peak of 690 nm, and it only qualifies for coverage when used incident to a physician's service during OPT.

The FDA first approved verteporfin on April 12, 2000. It was added to the United States Pharmacopoeia on July 18, 2000, which is what makes it a drug under §1861(t)(1) of the Social Security Act. That matters for your reimbursement pathway — it establishes the legal basis for Medicare coverage under the drugs and biologicals benefit category.

The CMS verteporfin coverage policy is tighter than many billing teams realize. Coverage is not automatic just because a patient has AMD. The diagnosis alone does not trigger reimbursement. You need the right lesion type, the right imaging documentation, and — in two of the three covered indications — evidence of recent progression.

Predominantly Classic Subfoveal CNV

This is the strongest covered indication. The patient must have predominantly classic subfoveal choroidal neovascularization (CNV), meaning the classic CNV component makes up 50% or more of the total lesion area. You need a fluorescein angiogram (FA) at the initial visit to establish this.

For subsequent visits, CMS accepts either an FA or an optical coherence tomography (OCT) to document treatment response. The OCT option has been effective since April 3, 2013. This is the most flexible of the three covered indications — there are no restrictions on visual acuity, lesion size, or number of retreatments.

Subfoveal Occult with No Classic CNV

This indication covers subfoveal occult CNV associated with AMD where no classic component is present. But this is where medical necessity requirements get more demanding. This indication is only covered when two specific criteria are both met.

First, the lesion must be small — four disk areas or less in size — at initial treatment or within the three months before initial treatment. Second, the lesion must show evidence of progression within those same three months before initial treatment.

What counts as progression? CMS is specific. You need documented deterioration of visual acuity (at least five letters lost on a standard eye chart), lesion growth of at least one disk area, or the appearance of blood associated with the lesion. All three are acceptable, but at least one must be documented.

Subfoveal Minimally Classic CNV

This third covered indication applies when the classic CNV component is present but occupies less than 50% of the total lesion area — hence "minimally classic." The same two-part progression and size criteria from the occult indication apply here as well.

If your lesion does not meet both the size threshold and the documented progression requirement, the claim will fail medical necessity. This is one of the more common claim denial triggers for verteporfin billing. Get the documentation right before you submit.

Prior Authorization Under NCD 350

The policy does not explicitly require prior authorization as a separate step. Coverage flows from meeting the documented medical necessity criteria. That said, if you're billing in a jurisdiction where your Medicare Administrative Contractor (MAC) has supplemental guidance, check for local LCD overlays. Some MACs add prior auth or pre-certification requirements on top of the NCD framework.

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CMS Verteporfin Exclusions and Non-Covered Indications

NCD 350 is explicit about what CMS will not cover. These exclusions are nationally binding — no MAC can override them at the local level.

CMS will not cover OPT with verteporfin for juxtafoveal or extrafoveal CNV lesions. If the lesion sits outside the fovea, it is not covered, period. This is a hard line in the coverage policy.

Two other non-covered situations: inability to obtain an FA (which blocks the imaging documentation requirement at initial visit), and atrophic or "dry" AMD. Dry AMD is the most common form of macular degeneration. Billing verteporfin for dry AMD is not a gray area — it is nationally non-covered. Any claim for that indication will be denied.

The policy also states that other uses of OPT with verteporfin not already addressed by CMS remain non-covered. This language is deliberately broad. It means CMS is not authorizing any off-label expansion of coverage at the national level.

What About Pathologic Myopia and Ocular Histoplasmosis?

These two indications — pathologic myopia and presumed ocular histoplasmosis syndrome — are not nationally covered or excluded. CMS defers these to individual MAC discretion through local coverage determinations (LCDs).

If your patient population includes these diagnoses, contact your MAC directly. Coverage will vary by region. Do not assume national coverage applies.

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Coverage Indications at a Glance

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CMS Verteporfin Billing Guidelines and Action Items 2026

The January 9, 2026 effective date is already past. If your practice performs OPT with verteporfin, these steps apply to claims you're submitting right now.

Copy Action Items

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CPT, HCPCS, and ICD-10 Codes for Verteporfin Under NCD 350

The policy data for NCD 350 does not include specific CPT or HCPCS codes. CMS did not publish a code list as part of this coverage determination update.

For verteporfin billing, your practice will typically use a HCPCS drug code for the verteporfin itself and a procedure code for the OPT administration. The exact codes in use at your practice should be confirmed against the current CMS HCPCS fee schedule and your MAC's claims processing instructions.

Reference Transmittal 2728 (Medicare Claims Processing) for claims processing guidance tied to this policy. This transmittal is the operative claims processing instruction document linked directly to NCD 350.

What to Do in the Absence of a Published Code List

Contact your MAC's provider relations line and confirm the HCPCS codes they expect for verteporfin drug billing and OPT procedure billing. Verify that your charge master reflects those codes before submitting. Do not assume the codes in your current charge capture are current — drug and procedure codes for photodynamic therapy have evolved since the original 2004 coverage effective date.

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