CurrentAlliance HealthPolicy 1A-13

Ocular Photodynamic Therapy (OPT)

Defines NC Medicaid coverage, eligibility, and clinical criteria for ocular photodynamic therapy (OPT) using verteporfin for beneficiaries in North Carolina.

Policy Summary

PayerAlliance Health

PolicyOcular Photodynamic Therapy (OPT)

Policy CodePolicy 1A-13

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionReport OPT with the most specific procedure code and bill verteporfin (J3396) when submitting claims; maintain fluorescein angiogram documentation demonstrating required lesion criteria prior to treatment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3covered indications listed

50%min classic CNV for AMD

<=7000-7500μmmax lesion size

verteporfinrequired drug

up to 5treatments/eye/yr

not required

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Coverage Criteria for Ocular Photodynamic Therapy (OPT)

Initial OPT coverage criteria

Covered when ALL of the following are met

General medical necessity: Procedure is medically necessary, individualized, consistent with symptoms or confirmed diagnosis, not in excess of beneficiary's needs; can be safely furnished; no equally effective and more conservative or less costly statewide option; not primarily for convenience.

from General Criteria Covered

Indications: One of the following indications must be met: (1) age-related macular degeneration (AMD) with angiographic criteria for predominantly classic subfoveal choroidal neovascularization (see AMD node); (2) subfoveal CNV secondary to ocular histoplasmosis with documented subfoveal CNV leakage and anticipated benefit over no treatment; (3) subfoveal CNV secondary to pathologic myopia with documented subfoveal CNV leakage and anticipated benefit over no treatment. OPT is only covered in conjunction with the drug verteporfin.

from Specific criteria covered by Medicaid

AMD-specific angiographic criteria: Fluorescein angiogram prior to treatment shows predominantly classic subfoveal CNV in which the area of classic CNV occupies at least 50% of the entire lesion and the greatest linear dimension is ≤7000–7500 microns. These angiographic criteria apply to the first treatment; additional treatments require clinical evidence of deterioration shown by persistent fluorescein leakage from CNV.>=50% classic; <=7000-7500 microns

AMD criteria and note on retreatment

Coverage with criteria and limits

Covered when beneficiary meets policy eligibility and clinical criteria in Sections 2.0 and 3.0 and limits below are observed

General coverage conditions: Beneficiary must meet eligibility in Section 2.0 and clinical criteria in Section 3.0; the service must not duplicate another provider's service and must not be experimental, investigational, or part of a clinical trial.

From General Criteria Not Covered

Prior approval: No prior approval is required for ocular photodynamic therapy.

Section 5.1

Treatment limits: Beneficiaries may receive up to five treatments per eye per year with a maximum of ten treatments per eye during a 2-year period.<=5 per eye per year; <=10 per eye per 2 years

Section 5.3.a

OPT is covered only when furnished in conjunction with the photosensitizing agent verteporfin. Coverage is limited to the indications specified in this policy (age-related macular degeneration, pathologic myopia, and ocular histoplasmosis) and only when verteporfin is used as part of the photodynamic therapy procedure.

The service is not covered when the beneficiary does not meet the eligibility requirements in Section 2.0, does not meet the clinical criteria in Section 3.0, when the procedure duplicates another provider's service, or when the procedure is experimental, investigational, or part of a clinical trial. (Note: Specific statement that "None Apply" appears for additional not-covered items.)

Ocular photodynamic therapy procedures are covered only when billed in conjunction with the drug verteporfin. Providers must report the appropriate procedure code(s) together with the verteporfin HCPCS code when applicable.

Services that are unsafe, ineffective, experimental or investigational, or not generally recognized as accepted medical practice are considered not medically necessary and are not covered under this policy. For beneficiaries under age 21, EPSDT requirements still apply and providers must document medical necessity to support exceptions to policy limits.

None Apply.

Coding and Billing

Placeholders for coding sections (ICD-10, CPT/PCS, Modifiers, Billing Units)mixed

No codes listed

Claim Typemixed

CMS-1500

Professional claim type

ICD-10 Codes (listed individually)ICD-10

H442A	Individual ICD-10 code listed in policy
H442A1	Individual ICD-10 code listed in policy
H442A2	Individual ICD-10 code listed in policy
H442A3	Individual ICD-10 code listed in policy
H442B	Individual ICD-10 code listed in policy
H442B1	Individual ICD-10 code listed in policy
H442B2	Individual ICD-10 code listed in policy
H442B3	Individual ICD-10 code listed in policy
H442C	Individual ICD-10 code listed in policy
H442C1	Individual ICD-10 code listed in policy

1–10 of 39

1/4

Covered CPT/HCPCS CodesmixedCovered

67221	CPT code listed in policy
67225	CPT code listed in policy
J3396	HCPCS code for verteporfin

Applicable ICD-10 CodesICD-10

H442A	ICD-10 diagnosis code listed
H442A1	ICD-10 diagnosis code listed
H442A2	ICD-10 diagnosis code listed
H442A3	ICD-10 diagnosis code listed
H442B	ICD-10 diagnosis code listed
H442B1	ICD-10 diagnosis code listed
H442B2	ICD-10 diagnosis code listed
H442B3	ICD-10 diagnosis code listed
H442C	ICD-10 diagnosis code listed
H442C1	ICD-10 diagnosis code listed

1–10 of 45

1/5

inv-13: Greatest linear dimension of CNV lesion — <= 7000-7500 microns

Greatest linear dimensionLesion greatest linear dimension must be ≤ 7000-7500 microns

ScopeApplies to the angiographic measurement prior to the first OPT treatment for AMD

Retreatment noteThese size criteria are intended to apply only to the first treatment; further treatments depend on clinical evidence of deterioration (persistent fluorescein leakage)

inv-14: Minimum proportion of classic CNV required — classic CNV occupies at least 50% of entire lesion

Minimum classic proportionClassic CNV must occupy at least 50% of the entire lesion on fluorescein angiogram

Provider Requirements, Documentation, and Billing Actions

Documentation Required

Eligibility Verification

Verify each Medicaid beneficiary's eligibility every time a service is rendered. Eligibility category may restrict coverage for this service.

Verify eligibility at each encounter per Section 2.1.1 General.

Prior Authorization

Prior Approval / EPSDT Note

Prior approval is not required for ocular photodynamic therapy (OPT). If a service does require prior approval under a different policy, beneficiaries under age 21 still require prior approval and EPSDT/NCTracks guidance applies.

Medicaid does not require prior approval for OPT.
If another policy requires prior approval, the requirement remains for beneficiaries under 21 (see NCTracks and EPSDT guidance).
NCTracks Provider Claims and Billing Assistance Guide: https://www.nctracks.nc.gov/content/public/providers/providermanuals.html

Background and Rationale

Ocular photodynamic therapy (OPT) is a two-step, FDA‑approved procedure that uses intravenous verteporfin followed by activation with non‑thermal laser light at the drug's absorption peak to selectively destroy abnormal choroidal neovascular vessels while sparing normal tissue. It is indicated for certain cases of age‑related macular degeneration (AMD), pathologic myopia, and ocular histoplasmosis.

Definitions

inv-30: Ocular photodynamic therapy (OPT) — A two-step procedure involving intravenous verteporfin followed by activation with laser light at the drug's absorption peak to selectively treat abnormal vessels

DefinitionOcular photodynamic therapy (OPT) is a two-step procedure involving intravenous verteporfin followed by activation with laser light at the drug's absorption peak to selectively destroy abnormal choroidal neovascular vessels while sparing normal tissue

Drug componentRequires intravenous injection of the photosensitizer verteporfin (Visudyne) prior to light activation

MechanismVerteporfin is activated by non-thermal laser light at the wavelength corresponding to its absorption peak, producing a photochemical reaction that closes abnormal vessels

inv-31: Predominantly classic subfoveal CNV — Lesion in which classic choroidal neovascularization occupies at least 50% of the entire lesion and has a greatest linear dimension ≤7000-7500 microns

Predominantly classic definitionA lesion in which classic choroidal neovascularization (CNV) occupies at least 50% of the entire lesion on fluorescein angiogram

Policy Summary

PayerAlliance Health

PolicyOcular Photodynamic Therapy (OPT)

Policy CodePolicy 1A-13

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

Reimbursement limits: Separate reimbursement is not allowed for intravenous infusion services associated with OPT.

Documentation: Providers must maintain required documentation, including the fluorescein angiogram, and submit it to NC Medicaid or its fiscal agent upon request.

Section 5.3.c

ApplicabilityRequired as part of the AMD-specific angiographic criteria prior to the first OPT treatment

PurposeEnsures lesion is predominantly classic subfoveal CNV to meet coverage criteria

inv-15: Billing specificity — Report the most specific CPT/HCPCS/UB-04 code available

Billing specificity requirementReport the most specific CPT, HCPCS, or UB-04 code that accurately and completely describes the procedure or service

Coding systemsUse the Current Procedural Terminology (CPT), HCPCS, and UB-04 Data Specifications Manual edition in effect at time of service

If no specific codeWhen no specific CPT/HCPCS code exists, report using the appropriate unlisted procedure or service code

EPSDT provider page: https://medicaid.ncdhhs.gov/

Documentation Required

Medical Necessity and Drug Linkage

OPT is covered only when medically necessary and only in conjunction with the drug verteporfin. Coverage requires documentation of pre-treatment diagnostics for the indication being treated and adherence to the general medical necessity criteria.

OPT is covered only in conjunction with verteporfin (J3396).
Medical necessity general criteria: individualized and specific to symptoms/diagnosis; safe to furnish; no equally effective, more conservative or less costly option available; not primarily for convenience.
Specific covered indications: age-related macular degeneration (AMD) with fluorescein angiogram showing predominantly classic subfoveal CNV occupying ≥50% of the lesion and greatest linear dimension ≤7000–7500 microns (criteria apply to first treatment); ocular histoplasmosis or pathologic myopia with subfoveal CNV leakage when anticipated benefit exceeds no treatment.

Documentation Required

Required Pre-Treatment Diagnostic Documentation

Prior to the first OPT treatment for AMD, a fluorescein angiogram demonstrating the required lesion characteristics must be documented and retained. Providers must maintain and produce diagnostic documentation upon request.

For AMD: fluorescein angiogram showing predominantly classic subfoveal CNV occupying at least 50% of the entire lesion and greatest linear dimension ≤7000–7500 microns (applies to first treatment).
For ocular histoplasmosis or pathologic myopia: documentation of subfoveal CNV leakage attributable to the condition.
Providers must maintain fluorescein angiogram and other relevant diagnostic records and submit them to NC Medicaid or its fiscal agent upon request.

Billing Rule

Required Procedure, Drug, and Diagnosis Coding Rules

Report the most specific CPT/HCPCS/UB-04 code that accurately describes the service. OPT procedures must be billed only in conjunction with verteporfin (J3396). ICD-10 combination diagnosis codes must be submitted with their matching combination codes to be accepted.

Report most specific procedure code(s): 67221, 67225 as applicable.
Report verteporfin drug code when used: J3396 (OPT is covered only when billed with verteporfin).
If no specific CPT/HCPCS code exists, bill an appropriate unlisted procedure code.
ICD-10: When using a combination diagnosis code, submit the matching combination code(s) as required for acceptance.

Denial Risk

Denial Risk and Common Documentation Failures

Claims may be denied if eligibility, medical necessity, documentation, or coding requirements are not met, or if the service duplicates another provider's service.

Denial triggers include: beneficiary not meeting Section 2.0 eligibility; failure to meet Section 3.0 medical necessity criteria; missing required diagnostic documentation (e.g., fluorescein angiogram); duplicate services; submission of ICD-10 combination codes without matching codes.

Size requirementGreatest linear dimension of the lesion must be ≤ 7000-7500 microns

TimingThese angiographic criteria are required prior to the first OPT treatment for AMD