CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Dermatologic Applications of Photodynamic Therapy (PDT) Coverage Criteria

Policy governing use and coverage of photodynamic therapy (topical photosensitizer plus light) for dermatologic conditions for Blue Cross Blue Shield - Rhode Island Commercial products; includes indications considered medically necessary and not medically necessary.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyDermatologic Applications of Photodynamic Therapy (PDT) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 1, 2022

Next Review DateN/A

Key ActionVerify member benefits and document diagnosis, anatomic site, lesion characteristics, and that surgery/radiation are contraindicated when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4 codesProcedure/drug codes listed as medically necessary

Face/scalp & UEAnatomic sites for medically necessary AK treatment

≥4/siteLesion threshold from trials

Acne, high‑risk BCC, HS, mycoses, cosmeticExplicit non-covered indications

~59

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Coverage Criteria

Medically necessary indications

Covered when ALL of the following are met for Commercial Products:

Actinic keratoses (face/scalp): Nonhyperkeratotic actinic keratoses of the face and scalp may be considered medically necessary for photodynamic therapy (PDT).Lesion count: 4 or more lesions per site (face or scalp).

Evidence from randomized controlled trials and meta-analyses demonstrates improved complete clearance for nonhyperkeratotic AKs on the face/scalp with PDT.

Actinic keratoses (upper extremities): Nonhyperkeratotic actinic keratoses of the upper extremities may be considered medically necessary for PDT.Lesion count: 4 or more lesions per site (upper extremities).

Systematic reviews and RCTs show superiority to placebo; some trials found cryotherapy may achieve higher complete clearance in nonface/nonscalp sites.

Low-risk basal cell carcinoma: Low-risk superficial and nodular basal cell carcinoma: PDT may be considered medically necessary only when surgery and radiation are contraindicated.

Surgery and radiation are the preferred treatments; systematic reviews indicate PDT may have lower cure rates but potentially better cosmetic outcomes when used because surgery/radiation are contraindicated.

Cutaneous squamous cell carcinoma in situ (Bowen disease): PDT may be considered medically necessary only when surgery and radiation are contraindicated.

RCTs and meta-analyses report efficacy versus some topical therapies and cryotherapy; PDT reserved when standard definitive therapy (surgery/radiation) is contraindicated.

Not medically necessary / Insufficient evidence

Not medically necessary / Insufficient evidence for the following:

Acne vulgaris: PDT for acne vulgaris is considered not medically necessary due to inconsistent randomized controlled trial results and a lack of demonstrated net health benefit; some trials report high rates of adverse events leading to cessation of treatment.

Meta-analyses did not find significantly better results with PDT versus placebo; evidence insufficient to determine improvement in net health outcome.

Noncancerous dermatologic conditions: PDT for hidradenitis suppurativa, fungal infections (mycoses), port-wine stains, and other noncancerous skin conditions is considered not medically necessary or investigational due to insufficient evidence.

Available evidence consists mainly of case series, uncontrolled studies, and limited RCT data; additional RCTs are needed to establish safety and efficacy.

Cosmetic indications: PDT for skin rejuvenation, hair removal, or other cosmetic uses is considered not medically necessary because evidence is insufficient to demonstrate a net health benefit.

Cosmetic applications are explicitly excluded in the policy language due to insufficient evidence.

Photodynamic therapy (PDT) is not medically necessary for dermatologic applications that are not explicitly listed as medically necessary in this policy. This exclusion includes, but is not limited to, conditions where evidence is insufficient or inconsistent (for example, acne vulgaris and a range of noncancerous skin disorders) and other uses not described under the policy’s covered indications.

Coverage and payment for services are subject to the member’s subscriber agreement or employer agreement, which supersede this medical policy. Providers should verify member-specific benefits and eligibility with the provider call center, since a service may be excluded or limited by those governing documents even if the medical policy discusses the service.

Specifically, PDT is considered not medically necessary for the following indications: acne vulgaris; high‑risk basal cell carcinoma; hidradenitis suppurativa; mycoses (fungal infections); and use as a cosmetic procedure (for example, skin rejuvenation or hair removal). These indications are excluded because available trials and reviews do not demonstrate consistent net health benefit.

If a service is determined to be not medically necessary or otherwise non‑covered under the member’s benefits, nonpayment may result. Providers may bill the member only if the member was informed and provided written agreement in advance to assume financial responsibility; otherwise the provider must follow applicable participation and billing agreements.

Coding

Covered procedure and drug codesmixedCovered

96567	Photodynamic therapy by external application of light to destroy premalignant lesions of the skin and adjacent mucosa with application and illumination, activation of photosensitive drug(s), per day
96574	Debridement of premalignant hyperkeratotic lesion(s) followed with photodynamic therapy by external application of light with application and activation of photosensitizing drug(s), per day
J7308	Aminolevulinic hydrochloric acid for topical administration, 20%, single unit dosage form (354 mg)
J7309	Methyl aminolevulinate (MAL) for topical administration, 16.8%, 1 gram

Covered ICD-10 diagnosis codesICD-10Covered

C44.0-C44.99	Malignant neoplasm of skin (ICD-10 range included for covered indications)
D04.0-D04.9	Carcinoma in situ of skin (Bowen disease) ICD-10 range
L57.0	Actinic keratosis

inv-09: Lesion count threshold — 4 or more lesions per site (face, scalp, or upper extremities)

Lesion count threshold4 or more lesions per site (face, scalp, or upper extremities)

Applicable anatomic sitesFace, scalp, upper extremities

Lesion type requiredNonhyperkeratotic actinic keratoses

Provider Actions and Requirements

Billing Rule

Prior authorization not required / Code guidance

Prior authorization is not required for photodynamic therapy (PDT) when billed with the appropriate procedure and diagnosis codes listed in this policy. Billing note: the separate physician E/M for the second visit (light exposure visit) should not be reported in addition to the PDT procedure when that visit is performed solely to administer light.

96567 Photodynamic therapy by external application of light, per day
96574 Debridement followed by PDT, per day
J7308 Aminolevulinic hydrochloric acid, 20% (354 mg)
J7309 Methyl aminolevulinate, 16.8%, 1 gram

Prior Authorization

Prior authorization / benefits verification

Background

Photodynamic therapy uses a topically applied photosensitizer (for example, aminolevulinic acid or methyl aminolevulinate) that preferentially accumulates in dysplastic or target skin cells and is then activated by a specific light source. Light activation (peaks reported near ~404–420 nm and 635 nm in the literature) generates reactive oxygen species that cause localized tissue injury and necrosis. PDT is most commonly used with a two‑visit approach (application then illumination), may require repeat treatments spaced about a week apart, and typically heals within 10–14 days with generally acceptable cosmetic outcomes for appropriate indications.

Definitions

inv-19: Photodynamic therapy (PDT) — brief definition

DefinitionLight activation of a topical photosensitizer (eg, aminolevulinic acid or methyl aminolevulinate) to generate reactive intermediaries that cause tissue injury and necrosis

Common agentsAminolevulinic acid (ALA), methyl aminolevulinate (MAL)

MechanismTopical agents accumulate in dysplastic cells, are metabolized to porphyrins and, upon photoactivation (404–420 nm and 635 nm), generate reactive oxygen species that destroy lesions

inv-20: Nonhyperkeratotic actinic keratosis — definition and anatomic site specification (face, scalp, upper extremities)

DefinitionActinic keratoses without hyperkeratosis (nonhyperkeratotic AKs)

Anatomic sites