Commercial

Medical Policy

Notification

Photodynamic Therapy (PDT) Using Levulan® Kerastick® or Ameluz® (Aminolevulinic Acid HCl [ALA])

Notification Issue Date:

This version of the policy will become effective 07/01/2019. The policy criteria were updated to change the position of Metvixia and the Aktilite lamp from medically necessary to not eligible for reimbursement, as this product in no longer available on the market. Ameluz with BF RhodoLED lamp was added to the policy as medically necessary with criteria. The policy criteria for Levulan were updated to include a new indication of actinic keratosis for upper extremities.

The following code was added to the policy: J7345

Title:

Photodynamic Therapy (PDT) Using Levulan® Kerastick® or Ameluz® (Aminolevulinic Acid HCl [ALA])

Policy #:

07.07.03o

Policy

MEDICALLY NECESSARY

Photodynamic therapy (PDT) using Levulan Kerastick with the BLU-U Blue Light Photodynamic Therapy Illuminator is considered medically necessary and, therefore, covered for any of the following indications:

Field cancerization/confluent epidermal dysplasia

Treatment of nonhyperkeratotic actinic keratoses of the face, scalp, or upper extremities
Treatment of squamous cell carcinoma in situ (Bowen disease) in individuals only when surgery AND radiation therapy are contraindicated

Treatment of superficial basal cell carcinoma in individuals only when surgery AND radiation therapy are contraindicated

PDT using Ameluz with BF RhodoLED lamp is considered medically necessary and, therefore, covered for any of the following indications:

Field cancerization/confluent epidermal dysplasia

Treatment of nonhyperkeratotic actinic keratoses of the face, scalp, or upper extremities
Treatment of squamous cell carcinoma in situ (Bowen disease) in individuals only when surgery AND radiation therapy are contraindicated

Treatment of superficial basal cell carcinoma in individuals only when surgery AND radiation therapy are contraindicated

COSMETIC

PDT using Levulan Kerastick with the BLU-U Blue Light Photodynamic Therapy Illuminator or Ameluz with BF RhodoLED lamp for the treatment of skin rejuvenation, hair removal, or acne scarring is considered a cosmetic service. Services that are cosmetic are a benefit contract exclusion for most products of the Company. Therefore, they are not eligible for reimbursement consideration.

NOT ELIGIBLE FOR REIMBURSEMENT

Methylaminolevulinate (Metvixia) is no longer manufactured and has been withdrawn from the market; therefore, it is not eligible for reimbursement.

EXPERIMENTAL/INVESTIGATIONAL

All other uses of PDT using Levulan Kerastick with the BLU-U Blue Light Photodynamic Therapy Illuminator, or Ameluz with BF RhodoLED lamp are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics. Uses of PDT using Levulan Kerastick with the BLU-U Blue Light Photodynamic Therapy Illuminator or Ameluz with BF RhodoLED lamp that are not supported in either this medical policy or the off-label coverage policy are considered experimental/investigational and, therefore, not covered.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, photodynamic therapy (PDT) using Levulan Kerastick and or Ameluz are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

Services that are cosmetic are a benefit contract exclusion for most products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

On December 3, 1999, Levulan Kerastick was approved by the FDA for the treatment of nonhyperkeratotic actinic keratoses of the face and scalp when used in combination with blue light irradiation from the BLU-U Blue Light Photodynamic Therapy Illuminator.

On December 3, 1999, the BLU-U Blue Light Photodynamic Therapy Illuminator was approved by the FDA for use in PDT in combination with Levulan Kerastick.

In June 2008, Metvixia Cream, in combination with the new Aktilite CL 128 lamp, was approved by the FDA for the treatment of thin and moderately thick, nonhyperkeratotic, nonpigmented actinic keratoses of the face and scalp in immunocompetent individuals. On June 27, 2014, Metvixia Cream, in combination with the new Aktilite CL 128 lamp, was discontinued from the market.

On May 10, 2016, Ameluz in combination with BF RhodoLED lamp was approved by the FDA for the lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp.

Description

Photodynamic therapy (PDT) is a medical procedure that involves the administration of a photosensitizing drug and subsequent exposure of tumor cells to a laser light source to induce cellular damage. PDT is a two-step process. In step one, the medication is topically applied to the affected tissue and allowed to absorb for a set period of time. The drug accumulates and is retained in dysplastic cells of the skin to a greater degree than normal tissue (i.e., the drug has a greater affinity for dysplastic cells). In step two, the affected skin tissue is exposed to a nonthermal laser light, and the photoactivation of the drug creates a cytotoxic reaction within the cells that destroys dysplastic lesions. The cytotoxic effect is dependent on light and oxygen.

In December 1999, the US Food and Drug Administration (FDA) approved PDT with Levulan Kerastick (aminolevulinic acid [ALA]) and the BLU-U Blue Light Photodynamic Therapy Illuminator (DUSA Pharmaceuticals Inc.; Wilmington, MA) for the treatment of minimally to moderately thick, nonhyperkeratotic actinic keratoses (AKs) of the face and scalp. PDT using Levulan Kerastick is a two-step treatment. Step one is the topical application of Levulan Kerastick lotion in the physician's office. The package insert recommends treating only one area at a time (either face or scalp lesions), not both simultaneously. The lotion remains on the skin from 14 to 18 hours, after which time the individual returns to the professional provider's office (step two), and the treated lesions are exposed to the blue light for 17 minutes.

AKs are premalignant skin lesions that result from damaging ultraviolet sunlight exposure. A small percentage of AKs may develop into squamous cell carcinomas. There are various treatment options for AK. Commonly used treatments include cryosurgery, curettage, and application of topical medications (e.g., 5-fluorouracil, imiquimod). Additional treatments for AK may include dermabrasion, excision, chemical peels, laser therapy, or PDT. Studies have shown good results with one or two treatments using PDT with topical ALA (Levulan Kerastick).

In addition to Levulan and Kerastick, in June 2008 the FDA approved PDT with Metvixia (methyl aminolevulinate hydrochloride [MAL]) (Penn Pharmaceutical Services Ltd., Tafarnaubach Industrial estate, Tredegar, Gwent, UK) and the Aktilite CL128 lamp, based on red light-emitting diode (LED) light, for the treatment of thin and moderately thick, nonhyperkeratotic, nonpigmented AKs of the face and scalp when the individual is immunocompetent and other standard therapies (e.g., cryosurgery, application of topical medications such as 5-fluorouracil, imiquimod) are known or suspected to be ineffective or contraindicated. On June 27, 2014, Metvixia cream, in combination with the new Aktilite CL 128 lamp, was discontinued from the market.

In May 2016, Ameluz® (ALA) in combination with BF-RhodoLED lamp, was approved by the FDA for the lesion-directed and field-directed treatment of AKs of mild-to-moderate severity on the face and scalp. The efficacy and safety of Ameluz in combination with BF-RhodoLED lamp was evaluated in three randomized, multicenter trials. Two of the trials were vehicle-controlled and double-blind. The other trial was double-blind with respect to vehicle and observer-blind regarding the active comparator arm. The primary endpoint was complete clearance 12 weeks after the last PDT. All of the clinical trials included a follow-up assessment after 6 and 12 months. In these trials, 212 individuals with four to eight mild-to-moderate AK lesions on the face/forehead and/or bald scalp were treated with Ameluz in combination with BF-RhodoLED lamp. In all three trials, 85%, 84%, and 91% of individuals with AK treated with Ameluz in combination with BF-RhodoLED lamp had complete clearance 12 weeks after the last PDT than the vehicle.

PDT is also recognized as an appropriate medical treatment in published clinical research and in several drug compendia for the treatment of some low-risk nonmelanoma skin cancers. The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology—Basal Cell Skin Cancer and the NCCN Clinical Practice Guidelines in Oncology—Squamous Cell Skin Cancer note that in individuals with low-risk, superficial basal cell skin cancer, in whom surgery and radiation are contraindicated or impractical, or with squamous cell carcinoma in situ (Bowen disease) that is low risk, alternative therapies such as topical 5-fluorouracil, topical imiquimod, photodynamic therapy (e.g., ALA, porfimer sodium), or vigorous cryotherapy may be considered, even though the cure rates may be lower than with surgical treatment modalities.

PDT has been used to improve cosmetic appearance, such as for the treatment of skin rejuvenation, hair removal, or acne scarring. Cosmetic services are those provided to improve an individual's physical appearance, from which no significant improvement in physiologic function can be expected. Emotional and/or psychological improvement alone does not constitute improvement in physiologic function.

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Wiegell SR, Haedersdal M, Philipsen PA, et al. Continuous activation of PpIX by daylight is as effective as and less painful than conventional photodynamic therapy for actinic keratoses; a randomized, controlled, single-blinded study. Br J Dermatol. 2008;158(4):740-746.

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Coding

CPT Procedure Code Number(s)

96567, 96573

THE FOLLOWING CODE IS USED TO REPRESENT PHOTODYNAMIC THERAPY FOR BASAL CELL CARCINOMA AND SQUAMOUS CELL CARCINOMA

96999

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

See Attachment A.

HCPCS Level II Code Number(s)

J7308 Aminolevulinic acid HCl for topical administration, 20%, single unit dosage form (354 mg)

J7345 Aminolevulinic acid HCl for topical administration, 10% gel, 10 mg

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 07.07.03o:

03/04/2026	This policy has been reviewed and reissued to communicate the Company's continued position on photodynamic therapy (PDT) using Levulan® Kerastick® or Ameluz® (Aminolevulinic Acid HCl [ALA]).
01/01/2026	This policy has been identified for the HCPCS code update, effective 01/01/2026. The following HCPCS codes has been terminated and removed from this policy: J7309.

Revisions From 07.07.03n:

10/20/2025

This policy was updated to clarify that methylaminolevulinate (Metvixia) [HCPCS code J7309] is not eligible for reimbursement because it is no longer manufactured and has been withdrawn from the market.

The following diagnosis codes have been removed from Attachment A of this policy: C44.101, C44.111, C44.121, C44.191, C44.201, C44.211, C44.221, C44.291, C44.601, C44.611, C44.621, C44.691, C44.701, C44.711, C44.721, C44.791, D04.10, D04.20, D04.60.

Revisions From 07.07.03m:

06/12/2024	This policy has been reviewed and reissued to communicate the Company's continued position on photodynamic therapy (PDT) using Levulan® Kerastick® or Ameluz® (aminolevulinic acid HCl [ALA]).
06/14/2023	This policy has been reviewed and reissued to communicate the Company's continued position on photodynamic therapy (PDT) using Levulan® Kerastick® or Ameluz® (aminolevulinic acid HCl [ALA]).
06/15/2022	This policy has been reviewed and reissued to communicate the Company's continued position on Photodynamic Therapy (PDT) Using Levulan® Kerastick® or Ameluz® (Aminolevulinic Acid HCl [ALA]).
06/02/2021	This policy has been reviewed and reissued to communicate the Company's continued position on Photodynamic Therapy (PDT) Using Levulan® Kerastick® or Ameluz® (Aminolevulinic Acid HCl [ALA]).
12/16/2020	This policy has been reviewed and reissued to communicate the Company's continued position on Photodynamic Therapy (PDT) Using Levulan® Kerastick® or Ameluz® (Aminolevulinic Acid HCl [ALA]).
07/01/2019	The policy criteria were updated to change the position of Metvixia and the Aktilite lamp from medically necessary to not eligible for reimbursement. Ameluz with BF RhodoLED lamp was added to the policy as medically necessary. The policy criteria for Levulan were updated to include a new indication of actinic keratosis for upper extremities. The following code was added to the policy: J7345

Revisions From 07.07.03l:

10/01/2018

This policy has been identified for the ICD-10 code update, effective 01/01/2018.

The following ICD-10 codes have been added to this policy:
C44.1021 C44.1022 C44.1091 C44.1092 C44.1121 C44.1122 C44.1191 C44.1192 C44.1221 C44.1222 C44.1291 C44.1292 C44.1921 C44.1922 C44.1991
C44.1992 D04.111 D04.112 D04.121 D04.122

The following ICD-10 codes have been termed from this policy:
C44.102 C44.109 C44.112 C44.119 C44.122 C44.129 C44.192 C44.199 D04.11 D04.12

01/01/2018

This policy has undergone a code update. The following changes were made:
The following CPT codes have been added to this policy:

96573; 96999

The following narrative has been revised in this policy:

96567

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date:

1/1/2026

Version Issued Date:

1/2/2026

Version Reissued Date:

3/4/2026