CMS Updates Coverage Policy for Ocular Photodynamic Therapy (NCD 349): What Ophthalmology Billing Teams Need to Know

CMS has issued a modification to National Coverage Determination (NCD) 349, which governs Medicare coverage of Ocular Photodynamic Therapy (OPT) with verteporfin for age-related macular degeneration (AMD). Effective March 12, 2026, this update clarifies and consolidates the coverage framework that has evolved through multiple CMS decisions dating back to 2001—including which AMD subtypes qualify, what diagnostic documentation is required, and which indications remain explicitly non-covered. If your practice bills Medicare for retinal disease treatment, this policy deserves a careful read before your next claim goes out.

Field	Detail
Payer	CMS (Centers for Medicare & Medicaid Services)
Policy	Ocular Photodynamic Therapy (OPT)
Policy Code	NCD 349
Change Type	Modified
Effective Date	2026-03-12
Impact Level	Medium
Specialties Affected	Ophthalmology, Retinal Surgery, Optometry (billing), RCM teams serving eye care practices
Key Action	Audit active AMD claims to confirm CNV lesion type, size, and progression documentation align with the updated covered indications before submission.

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What CMS NCD 349 Actually Covers: OPT with Verteporfin and AMD Indications

OPT is not a standalone procedure under Medicare. The Centers for Medicare & Medicaid Services makes clear that OPT is only covered when used in conjunction with verteporfin, the IV photosensitizing drug administered before laser exposure. If your documentation doesn't reflect verteporfin use, coverage does not apply—full stop.

The policy was first implemented July 1, 2001, with a narrow indication: neovascular AMD with predominantly classic subfoveal choroidal neovascularization (CNV) lesions, where classic CNV occupies 50% or more of the entire lesion area. That threshold was established by fluorescein angiogram (FA) at the initial visit.

As of April 1, 2004, CMS significantly expanded the covered indications—and the March 2026 modification carries those expanded criteria forward. Billing teams should treat these as the operative coverage rules now in effect.

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CMS Medicare Coverage Criteria for OPT: Three Covered AMD Indications

Under NCD 349, OPT with verteporfin is nationally covered for three distinct AMD presentations. Two of them come with additional medical necessity requirements your documentation must support.

Indication 1 — Predominantly Classic Subfoveal CNV

Coverage applies when classic CNV occupies ≥ 50% of the total lesion area at the initial visit, confirmed by FA. For subsequent treatment visits, CMS accepts either:

#	Covered Indication Copy
1	An FA (effective April 1, 2004), or
2	Optical coherence tomography (OCT) (effective April 3, 2013)

There are no requirements related to visual acuity, lesion size, or number of re-treatments for predominantly classic lesions. This is the most permissive of the three covered presentations.

Indication 2 — Subfoveal Occult with No Classic CNV

CMS determined the evidence is adequate to cover this subtype, but only when both of the following conditions are met:

#	Covered Indication Copy
1	The lesion is 4 disk areas or less in size at the time of initial treatment, or within the 3 months prior to initial treatment.
2	The lesion has shown documented evidence of progression within the 3 months prior to initial treatment.

Acceptable evidence of progression includes at least one of:

#	Covered Indication Copy
1	Deterioration of visual acuity (at least five letters on a standard eye examination chart)
2	Lesion growth (increase of at least one disk area)
3	Appearance of blood associated with the lesion

Indication 3 — Subfoveal Minimally Classic CNV

This applies when classic CNV occupies less than 50% of the entire lesion area. The same two conditions above—lesion size of 4 disk areas or less, plus documented progression within the prior 3 months—must be satisfied.

Both Indications 2 and 3 require tight, time-stamped documentation. If your chart doesn't reflect lesion size and progression evidence within that 90-day window, expect a denial.

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CMS Non-Covered OPT Indications Under NCD 349

CMS is equally explicit about what is not covered, and these exclusions are national—no local contractor discretion applies. Under Section C of NCD 349, OPT with verteporfin for AMD is not covered in the following situations:

• Juxtafoveal or extrafoveal CNV lesions — lesions located outside the fovea do not qualify regardless of lesion characteristics
• Inability to obtain a fluorescein angiogram — FA is required for initial classification; if it can't be performed, coverage is not available
• Atrophic or "dry" AMD — OPT is not covered for this AMD subtype under any circumstances

Any AMD indication not explicitly addressed by CMS also defaults to non-covered. Do not submit claims for unlisted AMD subtypes expecting favorable adjudication.

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Other Ocular Indications: Local Coverage Contractor Discretion Applies

NCD 349 does not govern OPT with verteporfin for non-AMD ocular conditions. Specifically, pathologic myopia and presumed ocular histoplasmosis syndrome are explicitly carved out and remain eligible for Local Coverage Determinations (LCDs) at individual Medicare Administrative Contractor (MAC) discretion.

If your practice treats these conditions with OPT, you'll need to check your MAC's applicable LCD rather than relying on NCD 349. Coverage and documentation requirements will vary by region.

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Affected Codes

The policy document for NCD 349 does not list specific CPT or HCPCS codes, and no ICD-10-CM codes are enumerated in the source data. Practices should consult their MAC's billing guidance and the CMS HCPCS database to identify the appropriate procedure codes for verteporfin infusion and the OPT laser procedure. ICD-10-CM codes for AMD subtypes (wet/neovascular vs. dry, with laterality) should be selected based on the specific covered indication being billed.

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What Your Billing Team Should Do

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