CurrentBlue Cross Blue Shield - MassachusettsPolicy 463

Photodynamic Therapy (Dermatologic)

Defines medical necessity, investigational uses, coding, and authorization guidance for photodynamic therapy (PDT) in dermatologic indications for Commercial members of Blue Cross Blue Shield - Massachusetts.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyPhotodynamic Therapy (Dermatologic)

Policy CodePolicy 463

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrecertification/preauthorization is required if photodynamic therapy is performed inpatient; no outpatient prior authorization is required for Commercial members.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Commercialpopulations addressed

3procedure codes listed

2drug codes listed

64references

2024guideline year cited

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inv-01: Medically Necessary Indications

Covered when ALL of the following conditions apply for Commercial Members:

Medically necessary indications: Photodynamic therapy (PDT) may be considered MEDICALLY NECESSARY for the following dermatologic conditions: nonhyperkeratotic actinic keratoses of the face and scalp; nonhyperkeratotic actinic keratoses of the upper extremities; low-risk basal cell carcinoma (eg, superficial and nodular) only when surgery and radiation are contraindicated; and cutaneous squamous cell carcinoma in situ (Bowen disease) only when surgery and radiation are contraindicated.

Applies to Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity.

inv-02: Investigational Indications

Investigational / Not established for other conditions

Investigational dermatologic applications: Photodynamic therapy (PDT) is considered INVESTIGATIONAL for dermatologic applications other than the indications listed as medically necessary. Examples include, but are not limited to: acne vulgaris; high-risk basal cell carcinomas; hidradenitis suppurativa; mycoses; and use as a technique for skin rejuvenation, hair removal, or other cosmetic indications.

Evidence for acne and several noncancerous dermatologic conditions is inconsistent, with RCTs showing mixed results and some trials reporting high adverse event rates.

inv-03: Insufficient Evidence

Insufficient evidence conditions: PDT for nonmetastatic invasive squamous cell carcinoma: current evidence (observational studies and systematic reviews of observational studies) is insufficient to determine improvement in net health outcome; randomized controlled trials are needed.

Conclusions cannot be drawn from small, uncontrolled studies.

Photodynamic therapy (PDT) used specifically as a technique for skin rejuvenation, hair removal, or other cosmetic indications is classified as INVESTIGATIONAL and is not considered a covered medical indication under this policy.

No explicit exclusions are listed in the reference material for this segment beyond those already stated elsewhere in the policy; the referenced documents include a Centers for Medicare & Medicaid Services National Coverage Determination for actinic keratosis but do not add additional exclusion statements in this segment.

PDT for acne vulgaris and for several noncancerous dermatologic conditions (for example, hidradenitis suppurativa, mycoses, and port‑wine stains) is considered investigational or not medically necessary in this policy. Randomized controlled trials and meta‑analyses have not consistently demonstrated benefit of PDT versus comparators, trials often had small heterogeneous samples, and some studies reported high rates of adverse events leading to treatment discontinuation; therefore the evidence is insufficient to conclude improvement in net health outcome.

This segment of the policy contains literature citations and reference listings (systematic reviews, randomized trials, guideline documents, and the CMS NCD) that support the evidence review but does not itself state additional separate not‑medically‑necessary conditions.

Coding

Covered CPT CodesCPTCovered

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.
96573	Photodynamic therapy by external application of light to destroy premalignant lesions of the skin and adjacent mucosa with application and illumination/activation of photosensitizing drug(s) provided by a physician or other qualified health care professional, per day.
96574	Debridement of premalignant hyperkeratotic lesion(s) (ie, targeted curettage, abrasion) followed with photodynamic therapy by external application of light to destroy premalignant lesions of the skin and adjacent mucosa with application and illumination/activation of photosensitizing drug(s) provided by a physician or other qualified health care professional, per day.

HCPCS drug codesHCPCSCovered

J7308	Aminolevulinic hydrochloric acid for topical administration, 20%, single unit dosage form (354 mg).
J7345	Aminolevulinic acid HCl for topical administration, 10% gel, 10 mg

ICD-10 Diagnosis Codes (sample from enumerated list)ICD-10

L57.0	Actinic Keratosis
C44.01	Basal Cell Carcinoma of Skin of Lip
D04.0	Carcinoma In Situ of Skin of Lip

Provider Actions / Authorization

Prior Authorization

Prior Authorization Guidance

Prior authorization is not required for outpatient services for Commercial Managed Care (HMO and POS) and Commercial PPO and Indemnity. Providers should verify member benefits and applicable plan rules at the time of service.

Commercial Managed Care (HMO and POS): Prior authorization not required for outpatient services
Commercial PPO and Indemnity: Prior authorization not required for outpatient services

Note

Prior Authorization: None Specified in References

No explicit prior authorization requirements are specified in the reference literature cited in this section. A CMS National Coverage Determination (NCD) for treatment of actinic keratosis is listed and may influence coverage decisions; providers should consult payer-specific rules and the member's contract.

Prior Authorization

Inpatient Authorization Requirement

Precertification/preauthorization IS REQUIRED if the procedure is performed inpatient. For outpatient procedures, see the prior authorization guidance above. Providers must verify authorization requirements for inpatient admissions before scheduling.

Inpatient services: precertification/preauthorization required

Documentation Required

Coding and Documentation

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers as applicable. Inclusion or exclusion of codes in the policy does not guarantee member coverage—verify member contract benefits.

Note

Reference Literature and Step Therapy

The reference literature supports clinical documentation and may inform medical necessity determinations, but contains no explicit documentation checklist, step therapy sequences, or therapeutic hierarchies.

No step therapy sequences or therapeutic hierarchies specified
No explicit documentation checklist included in references

Definitions

inv-20: Photodynamic therapy (PDT) — definition and mechanism summary

DefinitionPhotodynamic therapy (PDT) is the light activation of a photosensitizer to generate highly reactive intermediaries that cause tissue injury and necrosis.

MechanismTopical agents (eg, ALA or methyl aminolevulinate) are metabolized to porphyrins that accumulate in dysplastic cells; photoactivation produces reactive oxygen species that are cytotoxic and destroy the lesion.

Clinical effectsPDT can cause erythema, burning, and pain; healing typically occurs within 10–14 days with generally acceptable cosmetic results.

Primary investigated usePrimarily investigated for actinic keratoses (AKs) and some nonmelanoma skin cancers.

inv-21: Photosensitizing agents / activation — common agents and activation wavelengths

Common topical agents5-aminolevulinic acid (ALA) and methyl aminolevulinate (methyl ester of ALA).

Cellular processingWhen applied topically these agents pass through abnormal keratin and are metabolized by underlying cells to photosensitizing concentrations of porphyrins that preferentially accumulate in dysplastic cells.

Activation wavelengthsPhotoactivation maximum absorption peaks at approximately 404–420 nm and 635 nm.

inv-22: Photodynamic therapy (PDT) — additional definition / context pulled from multiple references

Therapeutic scopePDT is described across randomized controlled trials and systematic reviews for treatment of actinic keratoses, basal cell carcinoma, Bowen's disease (squamous cell carcinoma in situ), acne, and other dermatologic conditions.

Evidence baseMultiple RCTs and systematic reviews/meta-analyses (see trials of BF-200 ALA, methyl aminolevulinate, and blue-light PDT) inform efficacy for AKs and selected superficial nonmelanoma skin cancers.

Limitations and adverse effectsEvidence is mixed for some indications (eg, acne, invasive squamous cell carcinoma); PDT may have inconsistent RCT results and adverse event rates vary by study.

Healing and outcomesHealing typically occurs within 10–14 days; cosmetic outcomes are generally acceptable in trial reports.

OpenPayer

Photodynamic Therapy (Dermatologic)

Coverage Criteria

Coding

Provider Actions / Authorization

Background

Definitions