Medicare Advantage

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. 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

Title:

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

Policy #:

MA07.056f

Policy

This policy uses coverage criteria primarily based on applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals and other applicable Medicare coverage documents. In the absence of fully established coverage criteria from these Medicare coverage documents for a specific medical service or item, the criterion/indication/service indicated by an asterisk below (*) is based on internal coverage criteria developed by the Company in consideration of peer-reviewed medical literature, clinical practice guidelines, regulatory status, and/or expert opinion.

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
Treatment of squamous cell carcinoma in situ (Bowen disease) in individuals only when surgery AND radiation therapy are contraindicated *(NCCN Guidelines Version 1.2024; Xue et al., 2022; Yongpisarn et al., 2022; Zhong et al., 2020; Bath-Hextall et al., 2013; Morton et al., 2006; Salim et al., 2003)

Treatment of superficial basal cell carcinoma in individuals only when surgery AND radiation therapy are contraindicated *(NCCN Guidelines Version 3.2024; Mpourazanis et al., 2020; Kim et al., 2018; Roozeboom et al., 2016; Zou et al., 2016; Wang et al., 2015; Szeimies et al., 2008; Bath-Hextall et al., 2007; Rhodes et al., 2007; Rhodes et al., 2004)

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
Treatment of squamous cell carcinoma in situ (Bowen disease) in individuals only when surgery AND radiation therapy are contraindicated *(NCCN Guidelines Version 1.2024; Xue et al., 2022; Yongpisarn et al., 2022; Zhong et al., 2020; Bath-Hextall et al., 2013; Morton et al., 2006; Salim et al., 2003)

Treatment of superficial basal cell carcinoma in individuals only when surgery AND radiation therapy are contraindicated *(NCCN Guidelines Version 3.2024; Mpourazanis et al., 2020; Kim et al., 2018; Roozeboom et al., 2016; Zou et al., 2016; Wang et al., 2015; Szeimies et al., 2008; Bath-Hextall et al., 2007; Rhodes et al., 2007; Rhodes et al., 2004)

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

This policy is consistent with Medicare's coverage determination. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

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

Services that are cosmetic are not covered by the Company because cosmetic services are not covered by Medicare. 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 patients. 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 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 non-melanoma 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, PDT (e.g., ALA, porfimer sodium), or vigorous cryotherapy may be considered, although 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.

References

Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: A publication from the United States and Canadian Hidradenitis Suppurativa Foundations: Part I: Diagnosis, evaluation, and the use of complementary and procedural management. J Am Acad Dermatol. 2019;81(1):76-90.

American Academy of Dermatology (AAD) Association. Actinic keratosis: Diagnosis and Treatment. Last Updated: 02/23/2022. Available at: https://www.aad.org/public/diseases/scaly-skin/actinic-keratosis#treatment. Accessed January 30, 2026.

Barbaric J, Abbott R, Posadzki P, et al. Light therapies for acne. Cochrane Database Syst Rev. 2016;9:CD007917.

Basset-Seguin N, Ibbotson SH, Emtestam L, et al. Topical methyl aminolaevulinate photodynamic therapy versus cryotherapy for superficial basal cell carcinoma: a 5 year randomized trial. Eur J Dermatol. 2008;18(5):547-553.

Bath-Hextall FJ, Matin RN, Wilkinson D, et al. Interventions for cutaneous Bowen's disease. Cochrane Database Syst Rev. 2013;6:CD007281.

Bath-Hextall FJ, Perkins W, Bong J, et al. Interventions for basal cell carcinoma of the skin. Cochrane Database Syst Rev. 2007;(1):CD003412.

Biofrontera Inc. Ameluz (aminolevulinic acid hydrochloride gel, 10%). Prescribing Information. Wakefield, MA: Biofrontera Inc.; September 2018.

Brian Jiang SI, Kempers S, Rich P, et al. A Randomized, Vehicle-Controlled Phase 3 Study of Aminolevulinic Acid Photodynamic Therapy for the Treatment of Actinic Keratoses on the Upper Extremities. Dermatol Surg. 2019;45(7):890-897.

Callen JP, Bickers DR, Moy RL. Actinic keratoses. J Am Acad Dermatol. 1997;36(4):650-653.

Calzavara-Pinton PG, Venturini M, Capezzera R, et al. Photodynamic therapy of interdigital mycoses of the feet with topical application of 5-aminolevulinic acid. Photodermatol Photoimmunol Photomed. 2004;20(3):144-147.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) 250.4: Treatment of Actinic Keratosis. [CMS Web site]. 11/26/2001. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=129&ncdver=1&NCAId=1&ver=20&NcaName=Actinic+Keratoses&bc=gEAAAAAAEAAA&. Accessed January 30, 2026.

Chun-Hua T, Li-Qiang G, Hua W, et al. Efficacy and safety of hemoporfin photodynamic therapy for port-wine stains in paediatric patients: A retrospective study of 439 cases at a single centre. Photodiagnosis Photodyn Ther. 2021;36:102568.

Cortelazzi C, Odorici G, Castagnetti E, et al. Comparative study of imiquimod 3.75% vs. photodynamic therapy for actinic keratosis of the scalp. Photodermatol Photoimmunol Photomed. 2021;37(5):404-409.

Dinehart SM. The treatment of actinic keratoses. J Am Acad Dermatol. 2000;42(1 Pt 2):25-28.

Dirschka T, Radny P, Dominicus R, et al. Long-term (6 and 12 months) follow-up of two prospective, randomized, controlled phase III trials of photodynamic therapy with BF-200 ALA and methyl aminolaevulinate for the treatment of actinic keratosis. Br J Dermatol. 2013;168(4):825-836.

Dirschka T, Radny P, Dominicus R, et al. Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a multicentre, randomized, observer-blind phase III study in comparison with a registered methyl-5-aminolaevulinate cream and placebo. Br J Dermatol. 2012;166(1):137-146.

Drake LA, Ceilley RA, Cornelison RL, et al. American Academy of Dermatology. Guidelines of care for actinic keratoses. Committee on Guidelines of Care. J Am Acad Dermatol. 1995;32(1):95-98.

Dusa Pharmaceuticals, Inc. Levulan Kerastick. [Dusa Pharmaceuticals Web site]. ND (WEB 1457 Rev G). Available at: https://www.levulanhcp.com/. Accessed January 30, 2026.

Eisen DB, Asgari MM, Bennett DD, et al. Guidelines of care for the management of actinic keratosis. J Am Acad Dermatol. 2021;85(4):e209-e233.

Ezzedine K, Painchault C, Brignone M. Systematic Literature Review and Network Meta-analysis of the Efficacy and Acceptability of Interventions in Actinic Keratoses. Acta Derm Venereol. 2021;101(1):adv00358.

Freeman M, Vinciullo C, Francis D, et al. A comparison of photodynamic therapy using topical methyl aminolevulinate (Metvix®) with single cycle cryotherapy in patients with actinic keratosis: a prospective, randomized study. J Dermatolog Treat. 2003;14:99-106.

Foley P, Freeman M, Menter A, et al. Photodynamic therapy with methylaminolevulinate for primary basal cell carcinoma: results of two randomized studies. Int J Dermatol. 2009;48(11):1236-1245.

Giehl KA, Kriz M, Grahovac M, et al. A controlled trial of photodynamic therapy of actinic keratosis comparing different red light sources. Eur J Dermatol. 2014;24(3):335-341.

Gold M, Bridges TM, Bradshaw VL, et al. ALA-PDT and blue light therapy for hidradenitis suppurativa. J Drugs Dermatol. 2004;3(1 suppl):S32-S35.

Gupta AK, Ryder JE. Photodynamic therapy and topical aminolevulinic acid: an overview. Am J Clin Dermatol. 2003;4(10):699-708.

Haedersdal M, Togsverd-Bo K, Wiegell SR, Wulf HC. Long-pulsed dye laser versus long-pulsed dye laser-assisted photodynamic therapy for acne vulgaris: A randomized controlled trial. J Am Acad Dermatol. 2008;58(3):387-394.

Hauschild A, Stockfleth E, Popp G, et al. Optimization of photodynamic therapy with a novel self-adhesive 5-aminolaevulinic acid patch: results of two randomized controlled phase III studies. Br J Dermatol. 2009;160(5):1066-1074.

Henney JE. From the Food and Drug Administration. JAMA. 2000;283(5):596.

Itoh Y, Ninomiya Y, Henta T, et al. Topical delta-aminolevulinic acid-based photodynamic therapy for Japanese actinic keratoses (abstract). J Dermatol. 2000;27(8):513-518.

Jeffes EW, McCullough JL, Weinstein GD, et al. Photodynamic therapy of actinic keratosis with topical 5-aminolevulinic acid. A pilot dose-ranging study. Arch Dermatol. 1997;133(6):727-732.

Jeffes EW, McCullough JL, Weinstein GD, et al. Photodynamic therapy of actinic keratoses with topical aminolevulinic acid hydrochloride and fluorescent blue light. J Am Acad Dermatol. 2001;45(1):96-104.

Kalka K, Merk H, Mukhtar H. Photodynamic therapy in dermatology. J Am Acad Dermatol. 2000;42(3):389-413.

Karrer S, Szeimies RM, Philipp-Dormston WG, et al. Repetitive Daylight Photodynamic Therapy versus Cryosurgery for Prevention of Actinic Keratoses in Photodamaged Facial Skin: A Prospective, Randomized Controlled Multicentre Two-armed Study. Acta Derm Venereol. 2021;101(1):adv00355.

Kim JYS, Kozlow JH, Mittal B, et al. Guidelines of care for the management of basal cell carcinoma. J Am Acad Dermatol. 2018;78(3):540-559.

Kurwa HA, Yong-Gee SA, Seed PT, Markey AC, Barlow RJ. A randomized paired comparison of photodynamic therapy and topical 5-fluorouracil in the treatment of actinic keratoses. J Am Acad Dermatol. 1999;41(3 Pt 1):414-418.

Lansbury L, Bath-Hextall F, Perkins W, et al. Interventions for non-metastatic squamous cell carcinoma of the skin: systematic review and pooled analysis of observational studies. BMJ. 2013;347:f6153.

Lindberg-Larsen R, Solvsten H, Kragballe K. Evaluation of recurrence after photodynamic therapy with topical methylaminolaevulinate for 157 basal cell carcinomas in 90 patients. Acta Derm Venereol. 2011;92(2):144-147.

McIntyre WJ, Downs MR, Bedwell SA. Treatment options for actinic keratoses. Am Fam Physician. 2007;76(5):667-671.

Medline Plus. Medical Encyclopedia. Actinic keratosis. [MedlinePlus Web site].11/12/2014. Last update: 10/13/2024. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000827.htm. Accessed January 30, 2026.

Mei X, Shi W, Piao Y. Effectiveness of photodynamic therapy with topical 5-aminolevulinic acid and intense pulsed light in Chinese acne vulgaris patients. Photodermatol Photoimmunol Photomed. 2013;29(2):90-96.

Morton CA, McKenna KE, Rhodes LE; British Association of Dermatologists Therapy Guidelines and Audit Subcommittee and the British Photodermatology Group. Guidelines for topical photodynamic therapy: update. Br J Dermatol. 2008;159(6):35-48.

Morton C, Campbell S, Gupta G, et al. Intraindividual, right-left comparison of topical methyl aminolaevulinate-photodynamic therapy and cryotherapy in subjects with actinic keratoses: a multicentre, randomized controlled study. Br J Dermatol. 2006;155(5):1029-1036.

Morton C, Horn M, Leman J, et al. Comparison of topical methyl aminolevulinate photodynamic therapy with cryotherapy or fluorouracil for treatment of squamous cell carcinoma in situ: Results of a multicenter randomized trial. Arch Dermatol. 2006;142(6):729-735.

Mostafa D, Tarakji B. Photodynamic therapy in treatment of oral lichen planus. J Clin Med Res. 2015;7(6):393-399.

Mosterd K, Thissen P, Nelemans P, et al. Fractionated 5-aminolaevulinic acid-photodynamic therapy vs. surgical excision in the treatment of nodular basal cell carcinoma: results of a randomized controlled trial. Br J Dermatol. 2008;159(4):864-870.

Mpourazanis G, Mpourazanis P, Stogiannidis G, et al. The effectiveness of photodynamic therapy and cryotherapy on patients with basal cell carcinoma: A systematic review and meta-analysis. Dermatol Ther. 2020:e13881.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Basal Cell Skin Cancer V1.2026. 01/01/2026. Available from: https://www.nccn.org/professionals/physician_gls/pdf/nmsc.pdf [log in required]. Accessed January 30, 2026.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Squamous Cell Skin Cancer V1.2026. 01/01/2026. Available from: https://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf [log in required]. Accessed January 30, 2026.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. Aminolevulinic Acid HCl. [NCCN Web site]. Available at: https://www.nccn.org/professionals/drug_compendium/content/. [via subscription only]. Accessed January 30, 2026.

National Institute for Health and Clinical Excellence (NICE). Photodynamic therapy for non-melanoma skin tumours (including premalignant and primary non-metastatic skin lesions). [NICE Web site]. Feb 2006. Available at: https://www.nice.org.uk/guidance/ipg155. Accessed January 30, 2026.

Neittaanmaki-Perttu N, Karppinen TT, Gronroos M, et al. Daylight photodynamic therapy for actinic keratoses: a randomized double-blinded nonsponsored prospective study comparing 5-aminolaevulinic acid nanoemulsion (BF 200) with methyl-5-aminolaevulinate. Br J Dermatol. 2014;171(5):1172-1180.

Nicklas C, Rubio R, Cardenas C, et al. Comparison of efficacy of aminolaevulinic acid photodynamic therapy vs. adapalene gel plus oral doxycycline for treatment of moderate acne vulgaris-A simple, blind, randomized, and controlled trial. Photodermatol Photoimmunol Photomed. 2019;35(1):3-10.

Novitas Solutions, Inc. Local Coverage Determination. L34938: Removal of Benign Skin Lesions. [Novitas Solutions Medicare Services Web site]. 09/26/2019. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=34938. Accessed January 30, 2026.

Orringer JS, Sachs DL, Bailey E, et al. Photodynamic therapy for acne vulgaris: a randomized, controlled, split-face clinical trial of topical aminolevulinic acid and pulsed dye laser. J Cosmet Dermatol. 2010;9(1):28-34.

Ortiz-Policarpio B, Lui H. Methyl aminolevulinate-PDT for actinic keratoses and superficial nonmelanoma skin cancers. Skin Therapy Letter. 2009;14(6):1-6.

Pariser D, Loss R, Jarratt M, et al. Topical methyl-aminolevulinate photodynamic therapy using red light-emitting diode light for treatment of multiple actinic keratoses: A randomized double-blind, placebo-controlled study. J Am Acad Dermatol. 2008;59(4):569-576.

Pariser DM, Eichenfield LF, Bukhalo M, et al. Photodynamic therapy with methyl aminolaevulinate 80 mg g(-1) for severe facial acne vulgaris: a randomized vehicle-controlled study. Br J Dermatol. 2016;174(4):770-777.

Pariser DM, Lowe NJ, Stewart DM, et al. Photodynamic therapy with topical methyl aminolevulinate for actinic keratosis: results of a prospective randomized multicenter trial. J Am Acad Dermatol. 2003;48(2):227-232.

Patel G, Armstrong AW, Eisen DB. Efficacy of photodynamic therapy vs other interventions in randomized clinical trials for the treatment of actinic keratoses: a systematic review and meta-analysis. JAMA Dermatol. 2014;150(12):1281-1288.

Piacquadio DJ, Chen DM, Farber HR, et al. Photodynamic therapy with aminolevulinic acid topical solution and visible blue light in the treatment of multiple actinic keratoses of the face and scalp: investigator-blinded, phase 3, multicenter trials. Arch Dermatol. 2004;140(1):41-46.

Poulin Y, Lynde CW, Barber K, et al. Non-melanoma skin cancer in Canada. Chapter 3: Management of actinic keratoses. J Cutan Med Surg. 2015;19(3):227-238.

Reinhold U, Dirschka T, Ostendorf R, et al. A randomized, double-blind, phase III, multicentre study to evaluate the safety and efficacy of BF-200 ALA (Ameluz®) vs. placebo in the field-directed treatment of mild-to-moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED® lamp. Br J Dermatol. 2016;175(4):696-705.

Reshetylo S, Narla S, Bakker C, et al. Systematic review of photodynamic therapy for the treatment of hidradenitis suppurativa. Photodermatol Photoimmunol Photomed. 2023;39(1):39-50.

Reynolds KA, Schlessinger DI, Vasic J, et al. Core Outcome Set for Actinic Keratosis Clinical Trials. JAMA Dermatol. 2020;156(3):326-333.

Reynolds RV, Yeung H, Cheng CE, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024;90(5):1006.e1-1006.e30.

Rhodes LE, de Rie M, Enstrom Y, et al. Photodynamic therapy using topical methyl aminolevulinate vs surgery for nodular basal cell carcinoma: results of a multicenter randomized prospective trial. Arch Dermatol. 2004;140(1):17-23.

Rhodes LE, de Rie MA, Leifsdottir R, et al. Five-year follow-up of a randomized prospective trial of topical methyl aminolevulinate photodynamic therapy vs surgery for nodular basal cell carcinoma. Arch Dermatol. 2007;143(9):1131-1136.

Roozeboom MH, Arits AH, Nelemans PJ, et al. Overall treatment success after treatment of primary superficial basal cell carcinoma: a systematic review and meta-analysis of randomized and nonrandomized trials. Br J Dermatol. 2012;167(4):733-756.

Roozeboom MH, Arits AHMM, Mosterd K, et al. Three-Year Follow-Up Results of Photodynamic Therapy vs. Imiquimod vs. Fluorouracil for Treatment of Superficial Basal Cell Carcinoma: A Single-Blind, Noninferiority, Randomized Controlled Trial. J Invest Dermatol. 2016;136(8):1568-1574.

Rubel DM, Spelman L, Murrell DF, et al. Daylight photodynamic therapy with methyl aminolevulinate cream as a convenient, similarly effective, nearly painless alternative to conventional photodynamic therapy in actinic keratosis treatment: a randomized controlled trial. Br J Dermatol. 2014;171(5):1164-1171.

Salim A, Leman JA, McColl JH, et al. Randomized comparison of photodynamic therapy with topical 5-fluorouracil in Bowen's disease. Br J Dermatol. 2003;148(3):539-543.

Schmieder GJ, Huang EY, Jarratt M. A multicenter, randomized, vehicle-controlled phase 2 study of blue light photodynamic therapy with aminolevulinic acid HCl 20% topical solution for the treatment of actinic keratoses on the upper extremities: the effect of occlusion during the drug incubation period. J Drugs Dermatol. 2012;11(12):1483-1489.

Schweiger ES, Riddle CC, Aires DJ. Treatment of hidradenitis suppurativa by photodynamic therapy with aminolevulinic acid: preliminary results. J Drugs Dermatol. 2011;10(4):381-386.

Serra-Guillen C, Nagore E, Hueso L, et al. A randomized pilot comparative study of topical methyl aminolevulinate photodynamic therapy versus imiquimod 5% versus sequential application of both therapies in immunocompetent patients with actinic keratosis: clinical and histologic outcomes. J Am Acad Dermatol. 2012;66(4):e131-137.

Shaaban D, Abdel-Samad Z, El-Khalawany M. Photodynamic therapy with intralesional 5-aminolevulinic acid and intense pulsed light versus intense pulsed light alone in the treatment of acne vulgaris: a comparative study. Dermatol Ther. 2012;25(1):86-91.

Shen JJ, Jemec GBE, Arendrup MC, et al. Photodynamic therapy treatment of superficial fungal infections: A systematic review. Photodiagnosis Photodyn Ther. 2020;31:101774.

Sotiriou E, Apalla Z, Maliamani F, et al. Intraindividual, right-left comparison of topical 5-aminolevulinic acid photodynamic therapy vs. 5% imiquimod cream for actinic keratoses on the upper extremities. J Eur Acad Dermatol Venereol. 2009;23(9):1061-1065.

Steeb T, Wessely A, Schmitz L, et al. Interventions for Actinic Keratosis in Nonscalp and Nonface Localizations: Results from a Systematic Review with Network Meta-Analysis. J Invest Dermatol. 2021;141(2):345-354.

Szeimies R, Matheson R, Davis S, et al. Topical methyl aminolevulinate photodynamic therapy using red light-emitting diode light for multiple actinic keratoses: a randomized study. Dermatologic Surg. 2009;35:586-592.

Szeimies RM, Ibbotson S, Murrell DF, et al. A clinical study comparing methyl aminolevulinate photodynamic therapy and surgery in small superficial basal cell carcinoma (8-20 mm), with a 12-month follow-up. J Eur Acad Dermatol Venereol. 2008;22(11):1302-1311.

Szeimies RM, Radny P, Sebastian M, et al. Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a prospective, randomized, double-blind, placebo-controlled phase III study. Br J Dermatol. 2010;163(2):386-394.

Szeimies RM, Stockfleth E, Popp G, et al. Long-term follow-up of photodynamic therapy with a self-adhesive 5-aminolaevulinic acid patch: 12 months data. Br J Dermatol. 2010;162(2):410-414.

Taub AF, Garretson CB. A randomized, blinded, bilateral intraindividual, vehicle-controlled trial of the use of photodynamic therapy with 5-aminolevulinic acid and blue light for the treatment of actinic keratoses of the upper extremities. J Drugs Dermatol. 2011;10(9):1049-1056.

Tschen EH, Wong DS, Pariser DM, et al. Phase IV ALA-PDT Actinic Keratosis Study Group. Photodynamic therapy using aminolaevulinic acid for patients with nonhyperkeratotic actinic keratoses of the face and scalp: phase IV multicentre clinical trial with 12-month follow up. Br J Dermatol. 2006;155(6):1262-1269.

U.S. Food and Drug Administration (FDA). Approved drug products with Therapeutic Equivalence Evaluations. Levulan. [FDA Web site]. Current through 12/31/2020. Available at: https://www.fda.gov/media/71474/download. Accessed January 30, 2026.

U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. BLU-U Blue Light Photodynamic Therapy Illuminator™. 510(k) summary. 09/09/2003. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf3/k031805.pdf. Accessed January 30, 2026.

U.S. Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Ameluz®. Product Insert. [FDA Web site]. 09/2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208081s002lbl.pdf. Accessed January 30, 2026.

U.S. Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Levulan® Kerastick®. Approval letter. [FDA Web site]. 06/27/1999. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-965_Levulan_Approv.pdf. Accessed January 30, 2026.

U.S. Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Levulan® Kerastick®. Product Insert. [FDA Web site]. 04/2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020965s015lbl.pdf. Accessed January 30, 2026.

U.S. Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Metvixia® (methyl aminolevulinate). Product Insert. [FDA Web site]. 11/2012. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021415s004lbl.pdf. Accessed January 30, 2026.

Wang H, Xu Y, Shi J, et al. Photodynamic therapy in the treatment of basal cell carcinoma: a systematic review and meta-analysis. Photodermatol Photoimmunol Photomed. 2015;31(1):44-53.

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.

Wiegell SR, Wulf HC. Photodynamic therapy of acne vulgaris using methyl aminolaevulinate: a blinded, randomized, controlled trial. Br J Dermatol. 2006;154(5):969-976.

Wojewoda K, Gillstedt M, Tovi J, et al. Optimizing treatment of acne with photodynamic therapy (PDT) to achieve long-term remission and reduce side effects. A prospective randomized controlled trial. J Photochem Photobiol B. 2021;223:112299.

Wu Q, Tu P, Zhou G, et al. A dose-finding study for hemoporfin in photodynamic therapy for port-wine stain: A multicenter randomized double-blind phase IIb trial. Photodermatol Photoimmunol Photomed. 2018;34(5):314-321.

Wu Y, Deng Y, Huang P. Application of red light therapy for moderate-to-severe acne vulgaris: A systematic review and meta-analysis. J Cosmet Dermatol. 2021;20(11):3498-3508.

Xiao Q, Li Q, Yuan KH, et al. Photodynamic therapy of port-wine stains: long-term efficacy and complications of Chinese patients. J Dermatol. 2011;38(12):1146-1152.

Xu X, Zheng Y, Zhao Z, et al. Efficacy of photodynamic therapy combined with minocycline for treatment of moderate to severe facial acne vulgaris and influence on quality of life. Medicine (Baltimore). 2017;96(51):e9366.

Xue WL, Ruan JQ, Liu HY, et al. Efficacy of Photodynamic Therapy for the Treatment of Bowen's Disease: A Meta-Analysis of Randomized Controlled Trials. Dermatology. 2022;238(3):542-550.

Yang Y, Shen S, Wang P, et al. Efficacy of photodynamic therapy in actinic cheilitis: A systematic review. Photodiagnosis Photodyn Ther. 2022;38:102782.

Yazdani Abyaneh MA, Falto-Aizpurua L, Griffith RD, et al. Photodynamic therapy for actinic cheilitis: a systematic review. Dermatol Surg. 2015;41(2):189-119.

Yazdanyar S, Zarchi K, Jemec GBE. Pain during topical photodynamic therapy - comparing methyl aminolevulinate (Metvix®) to aminolaevulinic acid (Ameluz®); an intra-individual clinical study. Photodiagnosis Photodyn Ther. 2017;20:6-9.

Yongpisarn T, Rigo R, Minkis K. Durable Clearance Rate of Photodynamic Therapy for Bowen Disease and Cutaneous Squamous Cell Carcinoma: A Systematic Review and Meta-Analysis. Dermatol Surg. 2022;48(4):395-400.

Zabawski EJ. Actinic Keratosis. [eMedicine Web site]. 02/24/2025. Available at: https://emedicine.medscape.com/article/1099775-overview. Accessed January 30, 2026.

Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945-973.e33.

Zane C, Facchinetti E, Rossi MT, et al. A randomized clinical trial of photodynamic therapy with methyl aminolaevulinate vs. diclofenac 3% plus hyaluronic acid gel for the treatment of multiple actinic keratoses of the face and scalp. Br J Dermatol. 2014;170(5):1143-1150.

Zhang L, Yang Y, Wang B, et al. Modified red light 5-aminolevulinic acid photodynamic therapy versus low-dose isotretinoin therapy for moderate to severe acne vulgaris: A prospective, randomized, multicenter study. J Am Acad Dermatol. 2023;89(6):1141-1148.

Zhang LC, Yang J, Huang YB, et al. Efficacy of hemoporfin photodynamic therapy for pulsed dye laser-resistant facial port-wine stains in 107 children: A retrospective study. Indian J Dermatol Venereol Leprol. 2022;88(2):275.

Zhong S, Zhang R, Mei X, et al. Efficacy of photodynamic therapy for the treatment of Bowen's disease: An updated systematic review and meta-analysis of randomized controlled trials. Photodiagnosis Photodyn Ther. 2020;32:102037.

Zloty D, Guenther LC, Sapijaszko M, et al. Non-melanoma skin cancer in Canada Chapter 4: Management of basal cell carcinoma. J Cutan Med Surg. 2015;19(3):239-248.

Zou Y, Zhao Y, Yu J, et al. Photodynamic therapy versus surgical excision to basal cell carcinoma: meta-analysis. J Cosmet Dermatol. 2016;15(4):374-382.

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 MA07.056f:

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 MA07.056e:

10/20/2025

This version of the policy will become effective 10/20/2025.

This policy was updated to communicate the following:

Photodynamic therapy using either Levulan Kerastick with the BLU-U Blue Light Photodynamic Therapy Illuminator or Ameluz with BF RhodoLED lamp is considered medically necessary for the treatment of nonhyperkeratotic actinic keratoses with no restrictions.
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, D04.30, D04.60.

Revisions From MA07.056d:

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]).
01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
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 MA07.056c:

10/01/2018

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

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 CM 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

Revisions From MA07.056b:

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

Revisions From MA07.056a:

03/01/2017

The policy has been reviewed and reissued to communicate the Company’s continuing position on Photodynamic Therapy (PDT) Using Levulan® Kerastick® (Aminolevulinic Acid HCl [ALA]) or Metvixia® (Methyl Aminolevulinate [MAL].

01/18/2017

The following policy criteria have been revised:

FROM:

Treatment of superficial basal cell carcinoma in individuals only when surgery or radiation therapy is contraindicated
Treatment of squamous cell carcinoma in situ (Bowen's disease) in individuals only when surgery or radiation therapy is contraindicated

TO:

Treatment of superficial basal cell carcinoma in individuals only when surgery and radiation therapy are contraindicated
Treatment of squamous cell carcinoma in situ (Bowen's disease) in individuals only when surgery and radiation therapy are contraindicated

The following ICD-10 CM codes have been added to 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, D04.70

Revisions From MA07.056:

08/05/2015	The policy has been reviewed and reissued to communicate the Company’s continuing position on Photodynamic Therapy (PDT) Using Levulan® Kerastick® (Aminolevulinic Acid HCl [ALA]) or Metvixia® (Methyl Aminolevulinate [MAL])
01/01/2015	This is a new policy.

Version Effective Date:

1/1/2026

Version Issued Date:

1/2/2026

Version Reissued Date:

3/4/2026