Ocular Photodynamic Therapy (OPT) — NCD 349 | CMS Coverage Update

TL;DR: The Centers for Medicare & Medicaid Services modified NCD 349 governing ocular photodynamic therapy (OPT) with verteporfin, effective January 9, 2026. Here's what billing teams need to know before submitting claims.

CMS ocular photodynamic therapy coverage policy under NCD 349 Medicare has a layered history of coverage decisions dating back to 2001 — and the January 9, 2026 update consolidates those decisions into a single, enforceable framework. If your practice treats age-related macular degeneration (AMD) and bills for OPT with verteporfin, this policy governs your reimbursement. The policy does not list specific CPT or HCPCS codes in this version's data, so your billing team must confirm applicable procedure codes through your Medicare Administrative Contractor or coding resources.

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Quick-Reference Table

Field	Detail Copy
Payer	CMS (Centers for Medicare & Medicaid Services)
Policy	Ocular Photodynamic Therapy (OPT) — NCD 349
Policy Code	NCD 349
Change Type	Modified
Effective Date	January 9, 2026
Impact Level	High — multiple AMD subtypes have distinct covered vs. non-covered status
Specialties Affected	Ophthalmology, retinal surgery, outpatient facilities billing ophthalmic procedures
Key Action	Audit your AMD diagnosis documentation against the lesion-type and progression criteria before submitting OPT claims

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CMS Ocular Photodynamic Therapy Coverage Criteria and Medical Necessity Requirements 2026

This is a policy with three distinct tiers of coverage. Get the tier wrong and you get a claim denial. Get it right and you have a defensible medical necessity argument. Here's how each tier works.

Tier 1: Predominantly Classic Subfoveal CNV — Covered

The most straightforward covered indication. OPT with verteporfin is covered when a patient has neovascular AMD with predominantly classic subfoveal choroidal neovascularization (CNV) lesions. "Predominantly classic" means the area of classic CNV occupies 50% or more of the area of the entire lesion. This determination is made at the initial visit using a fluorescein angiogram (FA).

For follow-up visits after the initial treatment, CMS requires either an FA or an optical coherence tomography (OCT) to assess treatment response. The OCT option for follow-up has been in place since April 3, 2013. CMS imposes no restrictions on visual acuity, lesion size, or number of re-treatments for this indication. That's meaningful — it gives treating physicians significant clinical latitude without triggering additional coverage hurdles.

Tier 2: Occult with No Classic CNV and Minimally Classic CNV — Covered with Conditions

This is where ocular photodynamic therapy billing gets complicated. CMS covers OPT with verteporfin for two additional AMD indications — but only when strict criteria are met.

The two additional covered indications are:

#	Covered Indication Copy
1	Subfoveal occult with no classic CNV associated with AMD
2	Subfoveal minimally classic CNV (where the area of classic CNV occupies less than 50% of the entire lesion) associated with AMD

Both indications require ALL of the following conditions at the time of initial treatment:

Lesion size: The lesions must be small — four disk areas or less — at the time of initial treatment, or within the three months prior to initial treatment.

Lesion progression: The lesions must show documented evidence of progression within the three months prior to initial treatment. Progression means at least one of the following:

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

Documentation here is everything. If your chart doesn't clearly show lesion size and progression within the three-month window, CMS has grounds to deny the claim. This is the kind of requirement that gets billing teams in trouble not because the treatment was wrong, but because the documentation didn't match the coverage policy criteria.

Diagnosing Tool Requirements

For the initially covered indication (predominantly classic subfoveal CNV), a fluorescein angiogram is required to establish the diagnosis. For occult or minimally classic CNV, an FA is also the baseline diagnostic tool. Follow-up visits for predominantly classic lesions can use either an OCT or an FA.

This matters for billing. If you're submitting claims for OPT follow-up visits, the medical necessity documentation must include the appropriate imaging result. An OCT for a follow-up visit on a predominantly classic lesion is covered starting April 3, 2013. Don't leave that out of your documentation package.

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CMS Ocular Photodynamic Therapy Exclusions and Non-Covered Indications

CMS is explicit about what this coverage policy does not cover. These are hard non-covered indications under NCD 349 Medicare — not gray areas where prior authorization might open a door.

Non-covered AMD indications include:

#	Excluded Procedure Copy
1	Juxtafoveal or extrafoveal CNV lesions — lesions located outside the fovea. If the CNV is not subfoveal, OPT is not covered.
2	Inability to obtain a fluorescein angiogram — if FA can't be performed, coverage is not available.
3	Atrophic or "dry" AMD — OPT is only covered for neovascular (wet) AMD. Dry AMD patients are categorically excluded.

Any other uses of OPT with verteporfin to treat AMD that CMS hasn't specifically addressed also remain non-covered. This is a closed list with an open-ended non-coverage tail. If a new AMD indication emerges that isn't explicitly addressed, assume it's non-covered until CMS issues a new determination.

One important carve-out: OPT with verteporfin for non-AMD ocular indications — such as pathologic myopia or presumed ocular histoplasmosis syndrome — is not governed by this NCD. Those fall under local coverage determination through individual Medicare Administrative Contractor discretion. If your practice treats these conditions with OPT, check with your MAC for applicable LCDs.

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Coverage Indications at a Glance

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CMS Ocular Photodynamic Therapy Billing Guidelines and Action Items 2026

The effective date of January 9, 2026 means this consolidated policy framework is already in force. Here's what your billing team needs to do now.

Copy Action Items

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CPT, HCPCS, and ICD-10 Codes for Ocular Photodynamic Therapy Under NCD 349

The NCD 349 policy data does not list specific CPT, HCPCS, or ICD-10 codes in this version. This is an important gap for ocular photodynamic therapy billing teams.

For procedure codes, the OPT procedure and verteporfin drug administration have historically been billed with specific HCPCS codes. Your Medicare Administrative Contractor is the authoritative source for which codes apply in your jurisdiction. Do not assume codes from previous versions of this policy are still current without verifying against your MAC's current guidance.

For diagnosis codes, ICD-10-CM codes for AMD subtypes (neovascular AMD, dry AMD, and related conditions) are critical to claim accuracy. The specific ICD-10-CM code must match the covered indication documented in the chart. A diagnosis code for dry AMD on an OPT claim, for example, will trigger denial — CMS explicitly excludes atrophic AMD from coverage.

Because no codes are enumerated in this policy version, the table below reflects that status clearly:

Code Type	Status Copy
CPT	Not specified in NCD 349 policy data — verify with your MAC
HCPCS	Not specified in NCD 349 policy data — verify with your MAC
ICD-10-CM	Not specified in NCD 349 policy data — verify with your MAC

Confirm all applicable codes with your Medicare Administrative Contractor or a certified ophthalmic coding resource before submitting claims under the January 9, 2026 effective date.

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