Notification

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


Notification Issue Date: 04/02/2019

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



Medicare Advantage Policy

Title:Photodynamic Therapy (PDT) Using Levulan® Kerastick® or Ameluz® (Aminolevulinic Acid HCl [ALA])
Policy #:MA07.056d

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

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:
  • Treatment of non-hyperkeratotic actinic keratoses of the face, scalp or upper extremities
  • 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

Photodynamic therapy (PDT) using Ameluz® with BF RhodoLED® lamp is considered medically necessary and, therefore, covered for any of the following indications:
  • Treatment of non-hyperkeratotic actinic keratoses of the face and scalp
  • 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

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 all products of the Company. Therefore, they are not eligible for reimbursement consideration.

NOT ELIGIBLE FOR REIMBURSEMENT

PDT using Metvixia® with the Aktilite® Lamp is no longer manufactured and has been withdrawn from 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.
Policy 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, 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 non-hyperkeratotic 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 photodynamic therapy (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, non-hyperkeratotic, non-pigmented 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 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, non-hyperkeratotic 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, MP22, 3AA, UK) and the Aktilite® CL128 lamp, based on Red Light-Emitting Diode (LED) Light, for the treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented actinic keratoses 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 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 actinic keratoses 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 twelve 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 4 to 8 mild to moderate actinic keratosis 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 actinic keratosis treated with Ameluz® in combination with BF-RhodoLED lamp had complete clearance twelve 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 NCCN Clinical Practice Guidelines in Oncology--Basal Cell Skin Cancerand the NCCN Clinical Practice Guidelines in Oncology--Squamous Cell Skin Cancer note that in individuals with low-risk, superficial basal cell skin cancer, where surgery and radiation are contraindicated or impractical, or with squamous cell carcinoma in situ (Bowen’s disease) that is low risk, alternative therapies such as topical 5-fluorouracil, topical imiquimod, photodynamic therapy (eg, aminolevulinic acid [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.
References

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Aminolevulinic Acid. Micromedex® Healthcare Series. DrugDex®. [Micromedex® Web site]. ]. Last modified: 06/15/2018. Available at: http://www.micromedexsolutions.com [via subscription only]. Accessed December 17, 2018.

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

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):547-53.

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.

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):144-7.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD).250.4: Treatment of actinic keratosis. [CMS Web site]. 11/26/01. 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 December 17, 2018.

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

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.

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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.

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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):1066-74.

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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.

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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):144-7.

McIntyre WJ, Downs MR, Bedwell SA. Treatment options for actinic keratoses. Am Fam Physician. 2007;76(5):667-71.

Medline Plus. Medical Encyclopedia. Actinic keratosis. [MedlinePlus Web site].11/12/2014. Last update: 11/6/2018. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000827.htm. Accessed December 17, 2018.

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. AKtion Investigators. 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):729-35.

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):864-70.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. Aminolevulinic Acid HCl. [NCCN Web site]. Available at: http://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=177. [via subscription only]. Accessed December 17, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Basal Cell Skin Cancer V1.2019. 08/31/2018. Available from: https://www.nccn.org/professionals/physician_gls/pdf/nmsc.pdf [log in required]. Accessed November 20, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology – Basal Cell Skin Cancer. V.1.2019. [NCCN Web site]. 08/31/2018. Available at: https://www.nccn.org/professionals/physician_gls/pdf/nmsc.pdf. Accessed December 17, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology – Squamous Cell Skin Cancer. V.2.2019. [NCCN Web site]. 10/23/16. Available at: https://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf. Accessed December 17, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Squamous Cell Skin Cancer V2.2019. 10/23/2018. Available from: https://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf [log in required]. Accessed November 20, 2018.

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.

Novitas Solutions, Inc. Local Coverage Determination. L34938: Removal of benign or premalignant skin lesions. [Novitas Solutions Medicare Services Web site]. 10/01/18. Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=34938&ver=15&name=314*1&UpdatePeriod=696&bc=AQAAEAAAAAAAAA%3d%3d&. Accessed December 17, 2018.

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, 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):227-32.

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.

Photodynamic therapy for non-melanoma skin tumours (including premalignant and primary non-metastatic skin lesions). [National Institue for Health and Clinical Excellence Web site]. Feb 2006. Available at: https://www.nice.org.uk/guidance/ipg155. Accessed December 17, 2018.

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):41-6.

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.

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.

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):539-43.

Schweiger ES, Riddle CC, Aires DJ. Treatment of hidradentis suppurativa by photodynamic therapy with aminolevulinic acid: preliminary results. J Drugs Dermatol. 2011;10(4):381-6.

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.

Spencer JM,Basile AL. Actinic Keratosis. [eMedicine Web site]. 08/31/2018. Available at: https://emedicine.medscape.com/article/1099775-overview Accessed December 17, 2018.

Szeimies R, Ibbotson S, Murrell D, et al; on behalf of the Excilight Study Group. 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 Venerol. 2008;22(11):1302-11.

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, 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):410-4.

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.

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US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Levulan® Kerastick®. Product Insert. [FDA Web site]. 09/2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208081s002lbl.pdf. Accessed December 17, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Metvixia® (methyl aminolevulinate) cream 16.8% For Topical Use Only. Prescribing information. [FDA Web site]. June 2008. (Revised 11/2012) Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021415s004lbl.pdf. Accessed December 17, 2018.

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):969-76.

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):1146-52.

Yazdani Abyaneh MA, Falto-Aizpurua L, Griffith RD, et al. Photodynamic therapy for actinic cheilitis: a systematic review. Dermatol Surg. 2015;41(2):189-198.

Yazdanyar S, Zarchi K, Jemec GBE. Pain during topical photodynamic therapy - comparing methyl aminolevulinate (Metvix(R)) to aminolaevulinic acid (Ameluz(R)); an intra-individual clinical study. Photodiagnosis Photodyn Ther. Aug 02 2017.

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.

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.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

96567, 96573


THE FOLLOWING CODE REPRESENTS METHYL AMINOLEVULINATE (METVIXIA®), WHICH IS NO LONGER MANUFACTURED AND HAS BEEN WITHDRAWN FROM THE MARKET:

96999



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


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

THE FOLLOWING CODE REPRESENTS METHYL AMINOLEVULINATE (METVIXIA®), WHICH IS NO LONGER MANUFACTURED AND HAS BEEN WITHDRAWN FROM THE MARKET:

J7309 Methyl aminolevulinate (MAL) for topical administration, 16.8%, 1 g



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Photodynamic Therapy (PDT) Using Levulan® Kerastick® or Ameluz® (Aminolevulinic Acid HCl [ALA])
Description: ICD-10 Diagnosis Code Number(s) and Narrative(s)







Policy History

Revisions from MA07.056d
07/01/2019The 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

MA07.056c
10/01/2018This 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 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

MA07.056b_
01/01/2018This 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

MA07.056a
03/01/2017The 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].
01/18/2017The 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

MA07.056
08/05/2015The 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])
01/01/2015This is a new policy.





Version Effective Date: 07/01/2019
Version Issued Date: 07/01/2019
Version Reissued Date: N/A