CMS modified NCD 128 governing photodynamic therapy coverage policy, effective March 7, 2026. Here's what billing teams need to know.

The Centers for Medicare & Medicaid Services updated NCD 128 Medicare policy for photodynamic therapy (PDT), with a focus on ocular photodynamic therapy (OPT) using verteporfin. The policy draws hard lines between covered and non-covered indications based on lesion classification — and those lines determine your reimbursement. The policy does not list specific CPT or HCPCS codes, so your billing team will need to work with your Medicare Administrative Contractor to confirm code-level requirements.


Quick-Reference Table

Field Detail
Payer CMS
Policy Photodynamic Therapy
Policy Code NCD 128
Change Type Modified
Effective Date 2026-03-07
Impact Level High
Specialties Affected Ophthalmology, Retina Surgery
Key Action Audit claims for OPT with verteporfin to confirm lesion classification and imaging documentation before billing

CMS Photodynamic Therapy Coverage Criteria and Medical Necessity Requirements 2026

NCD 128 is the National Coverage Determination governing Medicare coverage of photodynamic therapy. This updated coverage policy applies to all Medicare Part B claims for photodynamic therapy billed under Physicians' Services.

PDT works by infusing a photosensitive drug — one designed to accumulate in diseased tissue — then targeting that tissue with a non-thermal laser. The laser is calibrated to the drug's specific absorption wavelength. When the light hits the drug, it activates and treats the tissue locally.

For ocular photodynamic therapy, the medical necessity criteria are highly specific. CMS covers OPT only when used with verteporfin (see also NCD 80.3 on photosensitive drugs). Without verteporfin, OPT is not covered under this NCD.

Classic Subfoveal CNV Lesions — Covered

The clearest covered indication is neovascular age-related macular degeneration (AMD) with predominately classic subfoveal choroidal neovascular (CNV) lesions. "Predominately classic" means the area of classic CNV takes up 50% or more of the total lesion area at the initial visit.

CMS requires a fluorescein angiogram (FA) at the initial visit to determine lesion classification. That's not optional — it's a medical necessity condition for coverage. At follow-up visits, your team needs either an optical coherence tomography (OCT) or another FA to assess treatment response.

CMS removed the prior authorization requirement for visual acuity, lesion size, and number of retreatments. There are no restrictions on those factors under this policy. That's a meaningful detail for practices that have historically over-documented to justify retreatments — your documentation burden on those elements is lighter here, but your imaging documentation burden is not.

Occult Subfoveal CNV Lesions — Not Covered

AMD with occult CNV lesions and no classic CNV is explicitly non-covered. This isn't a gray area. If the fluorescein angiogram shows occult-only disease, Medicare will not reimburse for OPT under NCD 128.

Document lesion classification carefully at every initial visit. A claim denial here almost always traces back to insufficient FA documentation rather than a billing error.

Other AMD Types and Other Ocular Conditions

Minimally classic CNV lesions, atrophic AMD, and dry AMD are also non-covered under this policy. Those are hard exclusions, not discretionary ones.

Other ocular conditions — pathologic myopia and presumed ocular histoplasmosis syndrome — sit in a different category. CMS allows individual Medicare Administrative Contractor discretion for those indications. Your local MAC may cover OPT with verteporfin for those conditions. Contact your MAC directly before billing for either indication.


CMS Photodynamic Therapy Exclusions and Non-Covered Indications

The exclusions in NCD 128 are explicit and worth knowing cold.

Occult subfoveal CNV (AMD, occult-only): Not covered. No exceptions under the NCD. CMS is clear that AMD without any classic CNV component does not meet medical necessity under this policy.

Minimally classic CNV lesions: Not covered. Even if there is some classic CNV present, if it represents less than 50% of the total lesion, OPT is non-covered under this determination.

Atrophic (dry) AMD: Not covered. OPT has no covered indication for atrophic AMD regardless of severity.

Other ocular indications (pathologic myopia, presumed ocular histoplasmosis syndrome): Not covered at the national level. These fall to MAC discretion. Check your local coverage determination before billing. If your MAC has an LCD addressing these conditions, that LCD governs — not NCD 128.

The real risk here is misclassification at billing. If a provider documents a CNV lesion without quantifying the classic component as ≥50% of the total lesion, your claim will look like an occult-only case to a claims reviewer. Train your ophthalmology coders to read FA reports and pull the relevant measurements before submitting.


Coverage Indications at a Glance

Indication Status Relevant Codes Notes
Neovascular AMD with predominately classic subfoveal CNV (≥50% classic component) Covered No codes listed in policy FA required at initial visit; OCT or FA required at follow-up
AMD with occult subfoveal CNV, no classic component Not Covered No codes listed in policy Hard NCD exclusion; no MAC discretion
Minimally classic CNV lesions (<50% classic component) Not Covered No codes listed in policy Hard NCD exclusion
+ 3 more indications

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This policy is now in effect (since 2026-03-07). Verify your claims match the updated criteria above.

CMS Photodynamic Therapy Billing Guidelines and Action Items 2026

This policy rewards practices with tight documentation workflows and punishes those relying on vague clinical notes. Here's what your billing team needs to do before the effective date of March 7, 2026.

#Action Item
1

Audit your OPT claims back 12 months. Pull all claims for photodynamic therapy and confirm each one includes documented lesion classification with a qualifying FA. Look for any claims where the classic CNV component isn't explicitly quantified. Those are your exposure points.

2

Update intake and documentation templates for ophthalmology. Every OPT encounter needs a documented measurement showing the classic CNV component is ≥50% of total lesion area. If your providers are describing lesions qualitatively rather than quantitatively, that changes now.

3

Confirm verteporfin is documented on every OPT claim. OPT without verteporfin is not covered under NCD 128. If you're billing for the procedure and the drug is on a separate claim or administered by a different entity, make sure your claim still links to the verteporfin infusion. Also cross-reference NCD 80.3 for photosensitive drug billing guidelines.

+ 3 more action items

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If your practice bills a significant volume of OPT and your documentation workflows aren't already built around these criteria, talk to your compliance officer before the effective date. The financial exposure from systematic misclassification is real.


Sample Version Diff Line-by-line changes
Previous VersionCurrent Version
Coverage is considered experimental and investigational for all indicationsCoverage is considered medically necessary when specific criteria are met
Prior authorization is not requiredPrior authorization is required for initial treatment
Documentation must include clinical historyDocumentation must include clinical history
+ 1 more action items

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CPT, HCPCS, and ICD-10 Codes for Photodynamic Therapy Under NCD 128

A Note on Code Availability

NCD 128 does not list specific CPT, HCPCS, or ICD-10 codes in the policy document. This is worth flagging directly: photodynamic therapy billing requires code-level guidance that this NCD does not supply at the national level.

Your billing team should contact your Medicare Administrative Contractor for code-specific billing guidelines. MACs often publish companion articles to NCDs that include applicable codes, billing instructions, and any prior authorization requirements at the local level. Do not assume a code is covered or non-covered based on NCD 128 alone — confirm with your MAC.

When you do get code guidance from your MAC, the relevant clinical distinctions will mirror the NCD: covered claims will need to reflect predominately classic subfoveal CNV with documented FA findings, and the drug charge for verteporfin should reference NCD 80.3.


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