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Medical Policy: 02.01.16
Original Effective Date: January 2002
Reviewed: August 2011
Revised: January 2010
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Photodynamic therapy (PDT) refers to light activation of a photosensitizer to generate highly reactive intermediaries, which ultimately cause tissue injury and necrosis. Photosensitizing agents, administered orally or intravenously, have been used in non-dermatologic applications and are being proposed for use with dermatologic conditions such as actinic keratoses and non-melanoma skin cancers.
Two common photosensitizing agents are 5-aminolevulinac acid (5-ALA) and its methyl ester methyl aminolevulinate (MAL). When applied topically they pass through the abnormal keratin overlying the lesion and accumulate preferentially in dysplastic cells. 5-ALA and MAL are metabolized by the underlying cells to photosensitizing concentrations of porphyrins. Subsequent exposure to photoactivation (maximum absorption at 404-420 nm and 635 nm, respectively) generates reactive oxygen species that are cytotoxic, ultimately destroying the lesion. PDT can cause erythema, burning, and pain. Healing occurs within 10 to 14 days, with generally acceptable cosmetic results. PDT with topical ALA has been investigated primarily as a treatment of actinic keratoses. It has also been investigated as a treatment of other superficial dermatologic lesions such as Bowen’s disease, acne vulgaris, mycoses, hidradenitis suppurativa, and superficial and nodular basal cell carcinoma. Potential cosmetic indications include skin rejuvenation and hair removal.
Actinic keratosis is the most common premalignant skin condition. The rough scaly plaques are the direct results of damage from ultraviolet light and other carcinogenic exposures. It is commonly seen on the sun-exposed skin of elderly patients with fair complexions. The available treatments for actinic keratoses can generally be divided into surgical and non-surgical methods. Surgical treatments used to treat one or a small number of dispersed individual lesions include excision, curettage (either alone or combined with electrodessication), and laser surgery. Non-surgical treatments include cryotherapy, topical chemotherapy (5-fluorouracil [5-FU] or masoprocol creams), chemexfoliation (also known as chemical peels), and dermabrasion. Topical treatments are generally used in patients with multiple lesions and the involvement of extensive areas of the skin. Under some circumstances, combinations of different treatment methods may be used.
Non-melanoma skin cancers are the most common malignancies in the Caucasian population. Basal cell carcinoma (BCC) is most often found in light-skinned individuals and is the most common of the cutaneous malignancies. Although the tumors rarely metastasize, they can be locally invasive if left untreated, leading to significant local destruction and disfigurement. The most prevalent forms of BCC are nodular BCC and superficial BCC. Bowen’s disease is a squamous cell carcinoma (SCC) in situ with the potential for significant lateral spread. Metastases are rare, with less than 5% of cases advancing to invasive SCC. Lesions may appear on sun-exposed or covered skin. Excision surgery is the preferred treatment for smaller non-melanoma skin lesions and those not in problematic areas, such as the face and digits. Other established treatments include topical 5-fuorouracil, imiquimod, and cryotherapy. Poor cosmesis resulting from surgical procedures and skin irritation induced by topical agents can be significant problems.
Levulan® Kerastick™ is a topical preparation of ALA used in conjunction with illumination with the BLU-U™ Blue Light Photodynamic Therapy Illuminator, a blue light source. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of non-hyperkeratotic actinic keratoses of the face and scalp.
Another variant of PDT for skin lesions is Metvixia® and the Aktilite CL 128 lamp, each of which received FDA approval in 2004. Metvixia consists of the topical application of methyl aminolevulinate (MAL) followed by exposure with the Altilite CL 128 lamp, a red light source. Metvixia is indicated for the treatment of non-hyperkeratotic actinic keratoses of the face and scalp in immunoincompetent patients when used in conjunction with lesion preparation (sharp debridement) in the physician’s office when other therapies are unacceptable or considered medically less appropriate.
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Prior Approval:
Not applicable
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Policy:
Photodynamic therapy for the treatment of actinic keratosis may be considered medically necessaryas a treatment of:
- non-hyperkeratotic actinic keratoses of the face and scalp.
- Superficial basal cell cancer only when surgery and radiation are contraindicated.
- Bowen’s disease (squamours cell carcinoma in situ) only when surgery and radiation are contraindicated.
Photodynamic therapy is considered investigational for other dermatologic applications, including, but not limited to, acne vulgaris, non-superficial basal cell carcinomas, hidradenitis suppurativa, or mycoses. No high-quality comparative studies have evaluated photodynamic therapy for acne or other dermatologic conditions. The evidence is insufficient to show that photodynamic therapy improves net health outcomes for these conditions.
Photodynamic therapy as a technique of skin rejuvenation, hair removal, or for other cosmetic indications is considered not medically necessary.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- 96567 photodynamic therapy for actinic keratosis.
- J7308 5-ALA (Levulan® Kerastick®) for topical administration.
- J3490 Metvixia Cream
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Selected References:
- Feldman SR, Fleischer AB, Williford PM, Jorizzo JL. Destructive procedures are the standard of care for the treatment of actinic keratoses. The Journal of American Academy of Dermatology1999;40:43-47
- Leber K, Perron VD, Sinni-McKeehen B. Common Skin Cancers in the United States: A Practical Guide for Diagnosis and Treatment. Nurse Practitioner Forum 1999;10 (2): 106-112
- Jeffes III EWB, Tang EH. Actinic Keratosis. The Journal of Clinical Dermatology2000 May-June;1(3):167-179
- Ormrod D, Jarvis B. Topical Aminolevulinic Acid HCl Photodynamic Therapy. The Journal of Clinical Dermatology2000 March-April;1 (2): 133-139
- Barnaby JWJ, Styles AR, Cockerell CJ. Actinic Keratoses. Drugs and Aging 1997 September;11(3)186-205
- ECRI Institute. Photodynamic Therapy with Aminolevulinic Acid for Treatment of Actinic Keratosis and Other Skin Lesions. Plymouth Meeting (PA): ECRI Institute; 2008 August 6. 17 p. [ECRI hotline response]. Also available: http://www.ecri.org.
- 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 Dec;159(6):1245-66.
- 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 therapy. J Cosmet Dermatol. 2010 Mar;9(1):28-34.
- Foley P, Freeman M, Menter A et al. Photodynamic therapy with methyl aminolevulinate for primary nodular basal cell carcinoma: results of two randomized studies. Int J Dermatol. 2009 Nov;48(11):1236-45.
- Fantini F, Greco A, Del Giovane C et al. Photodynamic therapy for basal cell carcinoma: clinical and pathological determinants of response. J Eur Acad Dermatol Venereol. 2011 Aug;25(8):896-901. doi: 10.1111/j.146803083.2010.03877.x. Epub 2010 Nov 4.
- Fayter D, Corbett M, Heirs M et al. A systematic review of photodynamic therapy in the treatment of pre-cancerous skin conditions, Barrett’s oesphagus and cancers of the biliary tract, brain, head and neck, lung, oesphagus and skin. Health Technol Assess. 2010 Jul;14(37):1-288.
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Policy History:
Date Reason Action
August 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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