| Effective Date:04/01/2012 |
Title:Photodynamic Therapy for Dermatologic Conditions
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| Revision Date:11/01/2018
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Document:BI333:00
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| CPT Code(s):96567, 96573, 96574, J7308-J7309, J7345
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Public Statement
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Effective Date:
a)
This policy
will apply to all services performed on or after the above revision date which
will become the new effective date.
b)
For all
services referred to in this policy that were performed before the revision
date, contact customer service for the rules that would apply.
Photodynamic therapy refers to light activation of a
photosensitizer to generate highly reactive oxygen intermediaries, which
ultimately cause tissue injury and necrosis. This therapy is covered for
treatment of actinic keratosis, superficial basal cell skin cancer and squamous
cell carcinoma in situ (Bowen’s disease). Any other use is considered
investigational and experimental.
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Medical Statement
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1)
Photodynamic therapy with topical 5 aminolevulinic acid or methyl
aminolevulinate is considered medically necessary and is covered for the
treatment of:
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Non-hyperkeratotic
actinic keratoses. Treated lesions that have not completely resolved
after 8 weeks may be treated a second time.
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Superficial basal
cell skin cancer only when surgery and radiation are contraindicated.
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Bowen’s disease (squamous
cell carcinoma in situ) only when surgery and radiation are
contraindicated.
2)
Surgery or radiation is the preferred treatment for superficial
basal cell cancer and Bowen’s disease. If photodynamic therapy is selected for
these indications because of contraindications to surgery or radiation, patients
need to be aware that it may have a lower cure rated in comparison with surgery
or radiation.
3)
Photodynamic therapy for any other skin indication is considered investigational
and is not covered.
Codes
Used In This BI:
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96567 |
Photodynamic therapy by external application of light to destroy
premalignant and/or malignant lesions of the skin and adjacent mucosa
(e.g., lip) by activation of photosensitive drug(s), each phototherapy
exposure session |
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96573 |
Photodynamic therapy by external application of light to destroy
premalignant and/or malignant lesions of the skin and adjacent mucosa
(e.g., lip) by activation of photosensitive drug(s), each phototherapy
exposure session
provided by a
physician or other qualified health care professional (new code
1/1/2018) |
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96574 |
Debridement of premalignant hyperkeratotic lesion(s) (ie, targeted
curettage, abrasion) followed with
photodynamic
therapy by external application of light to destroy premalignant lesions
of the skin and adjacent mucosa with application and
illumination/activation of photosensitizing drug(s) provided by a
physician or other qualified health care professional, per day (new code
1/1/2018) |
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J7308 |
Aminolevulinic acid HCl for topical administration, 20%, single unit
dosage form (354 mg) |
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J7309 |
Methyl aminolevulinate (mal) for topical administration, 16.8%, 1 gram |
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J7345 |
Aminolevulinic acid HCl for topical administration, 10% gel, 10mg |
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Limits
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1)
Facial and
scalp actinic keratosis may not be treated simultaneously.
2)
Treatment may
be repeated in 8 weeks, if the lesions are not completely resolved.
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Reference
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Aetna Clinical Policy Bulletin 0567, Actinic Keratosis Treatments, reviewed
10/05/2011.
Basset-Seguin N, Ibbotson S, et al.(2005) MAL-PDT vs. cryotherapy in primary
sBCC:results of 48-month follow up. J Eur Acad Dermatol Venereol 2005; 19(suppl
2):237.
Bath-Hextall FJ, Perkins W, et al.(2007) Interventions for basal cell carcinoma
of the skin. Cochrane Database Syst Rev. 2007; (1):CD003412.
Braathen LR, Szeimies RM, et al.(2007) Guidelines on the use of photodynamic
therapy for nonmelanoma skin cancer: an international consensus. International
Society for Photodynamic Therapy in Dermatology, 2005. J Am Acad Dermatol, 2007;
56:125-43.
Calzavara-Pinton PG, Venturini M, et al.(2004) Photodynamic therapy of
interdigital mycoses of the feet with topical application of 5-aminolevulinic
acid. Photodermatol Photoimmunol Photomed 2004; 20(3):144-7.
Fantini F, Greco A, Del Giovane C et al.(2010) Photodynamic therapy for basal
cell carcinoma: clinical and pathological determinants of response. J Eur Acad
Dermatol Venereol 2010 [Epub before print].
Feldman SR, Fleischer AB, et al.(1999) Destructive procedures are the standard
of care for treatment of actinic keratosis. J Am Acad Derm 1999; 40(1.
Foley P, Freeman M, Menter A et al.(2009) Photodynamic therapy with
methylaminolevulinate for primary basal cell carcinoma: results of two
randomized studies. Int J Dermatol 2009; 48(11):1236-45.
Freeman M, Vinciullo C, et al.(2003) A comparison of photodynamic therapy using
topical methyl aminolevulinate (Metvix) with single cycle cryotherapy in
patients with actinic keratosis: a prospective, randomized study. J Dermatol,
2003; 14:99-106.
Gold M, Bridges TM, et al.(2004) ALA-PDT and blue light therapy for hidradenitis
suppurativa. J Drugs Dermatol, 2004; 3(1suppl):S32-5.
Jeffes EW, McCullough JL, et al.(1997) Photodynamic therapy of actinic keratosis
with topical 5-aminolevulinic acid; a pilot dose-ranging study. Arch Derm 1997;
133:727-732.
Jeffes EW, McCullough JL, et al.(2001) Photodynamic therapy of actinic keratosis
with topical aminolevulinic acid hydrochloride and fluorescent blue light. J Am
Acad Derm 2001; 45:96-104.
Kurwa, HA, Yong-Gee SA, et al.(1999) A randomized paired comparison of
photodynamic therapy and topical 5-fluorouracil in the treatment of actinic
keratosis. J Am Acad Derm 1999; 41: 414-8.
Morton C, Campbell S, Gupta G et al; AKtion Investigators.(2006) Intraindividual,
right-left comparison of topical methyl aminolaevulinate-photodynamic therapy
and cryotherapy in subjects with actinic keratosis: a multicenter, randomized
controlled study. Br J Dermatol, 2006; 155:1029-36.
Morton C, Horn M, et al.(2006) 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; 142:729-35.
National Comprehensive Cancer Network. Practice Guidelines in Oncology- v1. 2010
Basal Cell and Squamous Cell Skin Cancers. Available online at: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
Last accessed January 2011.
Ormond D, Jarvis B.(2000) Aminolevulinic acid HCL photodynamic therapy. Am J
Clin Derm 2000; 1 (2): 133-139.
Orringer JS, Sachs DL, Bailey E et al.(2010) 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.
Pariser DM, Lowe NJ, et al.(2003) Photodynamic therapy with topical methyl
aminolevulinate for actinic keratosis: results of a prospective randomized
multicenter trial. J Am Acad Dermatol, 2003;48:227-32.
Pfenninger JL, Fowler GC.(1994) Procedures for primary care physicians. Mosby-Year
Book, Inc 1994.
Piacquadio DJ, Chen DM, et al.(2004) Photodynamic therapy with aminolevulinic
acid topical solution and visible blue light in the treatment of multiple
actinic keratosis of the face and scalp: investigator-blinded, phase 3,
multicenter trials. Arch Dermatol 2004;140:41-6.
Practice Guidelines in Oncology – v.1.2007 Basal Cell and Squamous Cell Skin
Cancers. http://www.nccn.org/professionals/physician_gls/PDF/nmsc.pdf http://www.nccn.org/professionals/physician_gls/PDF/nmsc.pdf.
Product Insert: Levulan Kerastick. www.fda.gov/cder/foi/label/1999/20965LBL.pdf;
1999.
Rhodes LE, de Rie M, and et al. (2004) Photodynamic therapy using topical methyl
aminolevulinate vs surgery for nodular basal cell carcinoma: results of a
multicenter randomized prospective trial. Arch Dernatol, 2004; 140:17-23.
rhodes LE, de Rie MA, et al.(2007) 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; 143:1131-6.
Salim A, Leman JA, et al.(2003) Randomized comparison of photodynamic therapy
with topical 5-fluorouracil in Bowen`s disease. Br J Dermatol, 2003; 148:539-43.
Sxeimies RM, Karrer S, et al.(1996) Photodynamic therapy with topical
application of 5 aminolevulinic acid in the treatment of actinic keratosis: an
initial clinical study. Derm 1996; 192: 245-251.
Szeimies R, Ibbotson S, et al; on behalf of the Excilight Study Group.(2008) 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 Jul 2 [Epub ahead of print].
Tschen EH, Wong DS, et al.(2006) Phase IV ALA-PDT Actinic Keratosis Study Group.
Photodynamic therapy using aminolaevulinic acid for patients with
non-hyperkeratotic actinic keratosis of the face and scalp: phase IV multicentre
clinical trial with 12-month follow up. Br J Dermatol, 2007; 155:1262-9.
Vinciullo C, Elliott T, Francis D, et al.(2005) Photodynamic therapy with
topical methyl aminolaevulinate for `difficult-to-treat` basal cell carcinoma.
Br J Dermatol, 2005; 152:765-72.
Wiegell SR, Haedersdal M, et al.(2008) Continuous activation of PpIX by daylight
is as effective as and less painful than conventional photodynamic therapy for
actinic keratosis; a randomized, controlled, single-blinded study. Br J
Dermatol, 2008; 158:740-6.
Wiegell SR, Wulf HC.(2006) Photodynamic therapy of acne vulgaris using methyl
aminolaevulinate: a blinded, randomized, controlled trial. Br J Dermatol, 2006;
154:969-76.
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Application to Products
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This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
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Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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