Phototherapy for the Treatment of Skin Disorders
DESCRIPTION
Psoriasis is a non-contagious, chronic skin disease characterized by patches of raised red skin covered by white flakes. The exact cause is unknown but psoriasis may be related to faulty signals sent by the body's immune system. These signals may accelerate the growth cycle in skin cells, which pile up on the surface when the body cannot shed them fast enough.
The National Psoriasis Foundation determines psoriasis coverage and severity by the body surface area (BSA) method also known as the Lattice System-physician global assessment (PGA) system. This system measures and defines mild, moderate and severe forms of psoriasis according to the amount of body surface area involved; the effect psoriasis has on the activities of daily living and the quality of the individual’s life. This tool is used to determine the type of treatment to be used and in the evaluation of the response to treatment.
The measurement tool is the palm of the open hand (from wrist to tips of fingers) with fingers tucked together and the thumb tucked to the side and is considered to be about one percent of the skin. Mild psoriasis is considered less than two percent of the body or the amount of body area covered by two palms of the hand. Moderate severity is three to ten percent of the body affected by psoriasis or three to ten corresponding palm sized areas. A severe case of psoriasis is considered more than ten percent of body area or ten palm sized areas.
Vitiligo, a non-contagious, pigmentation disorder, usually affects the appearance of the skin but can affect the mucous membranes and retina of the eyes. White patches occur with destruction of melanocytes, the cells that make pigment. This disorder may be associated with some autoimmune diseases. PUVA therapy has been found to improve the cosmetic appearance of vitiligo by producing re-pigmentation. UVB therapies are also used to treat vitiligo and re-pigment skin.
PUVA (Psoralens with Ultraviolet A) therapy is a symptomatic treatment that uses an oral psoralen derivative in conjunction with ultraviolet A (UVA) light (sunlight or artificial) for photochemotherapy of skin conditions such as psoriasis and vitiligo that is unresponsive to conservative treatment such as topical corticosteroids, coal/ tar preparations, and ultraviolet light. Due to the increased potential for side effects PUVA is to be provided in a clinical setting under a physician’s supervision to control dosage and assess treatment response.
Targeted phototherapy describes the use of ultraviolet light that can be focused on specific body areas or lesions to treat patients with psoriasis and vitiligo. Conventional phototherapeutic options for treatment of psoriasis and vitiligo include phototherapy with both broad and narrowband ultraviolet B (UVB). UVB phototherapy with or without topical preparations, e.g. emollients or coal tar, also known as Goeckerman or modified Goeckerman therapy, has been commonly used to treat patients with moderate to severe psoriasis and unresponsive vitiligo. UVB is typically directed to the whole body or large sections of the body with light panels or light cabinets, requiring multiple treatments given several times a week. Broadband UVB devices, which emit wavelengths from 290 to 320 nm have been largely replaced by narrowband UVB (NB-UVB) devices. NB-UVB devices eliminate wavelengths below 296 nm, which are considered erythmogenic and carcinogenic but not therapeutic. NB-UVB is more effective than BB-UVB.
Lasers and targeted UVB lamps are considered to be equivalent devices; targeted ultraviolet devices are comparable to ultraviolet light panels for treatment purposes. Original NB-UVB devices consisted of a Phillips TL-01 fluorescent bulb with a maximum wavelength (lambda max) at 311 nm. Xenon chloride (XeCl) lasers and lamps have been developed as targeted NB-UVB treatment devices. These devices generate monochromatic or very narrow band radiation with a lambda max of 308 nm. The FDA indicated use for these devices is targeted UVB phototherapy for the treatment of psoriasis, vitiligo and other skin conditions.
Surgical lasers work by producing intense beams of virtually non-divergent light that can cut, seal, and vaporize abnormal skin tissues. A surgical laser emits one specific color, or wavelength, of light that can be varied in its intensity and pulse duration. In a process known as selective photothermolysis, hemoglobin within the dilated or enlarged blood vessels of the cutaneous lesion preferentially absorb energy from the lasers. The lesions are destroyed as a result of thermal damage by narrowband ultraviolet B (NB-UVB) devices.
POLICY
Phototherapy (UVA/UVB) for the treatment of psoriasis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Phototherapy (UVA/UVB) for the treatment of vitiligo is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Phototherapy (UVA/UVB) for the treatment of other conditions/diseases, including, but not limited to, the following: the treatment of generalized psoriasis and psoriatic arthritis is considered investigational
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Phototherapy for the treatment of skin disorders is considered medically appropriate for ANY ONE of the following:
Phototherapy with UVA for ANY ONE of the following:
Treatment of severe disabling psoriasis unresponsive to conservative therapy (e.g., topical corticosteroids, coal/tar preparations, and ultraviolet light)
Treatment of vitiligo unresponsive to conservative treatment (e.g. topical corticosteroids / immunomodulators such as ointments containing tacrolimus or pimecrolimus)
Phototherapy with targeted UVB therapies including narrowband, Laser and UVB with or without topical preparations, (e.g. emollients or tar, Goeckerman or modified Goeckerman therapy,) for ANY ONE of the following:
Treatment of mild psoriasis unresponsive to conservative treatment (i.e. topical corticosteroids, coal/ tar preparations, and ultraviolet light).
Treatment of moderate to severe localized psoriasis
Treatment of vitiligo unresponsive to conservative treatment, (e.g. topical corticosteroids / immunomodulators such as ointments containing tacrolimus or pimecrolimus)
Home treatment with UVB phototherapy if ALL of the following criteria are met:
Physician order to include ALL of the following:
Diagnosis of mild psoriasis unresponsive to conservative treatment or moderate to severe psoriasis
Dose, UVB strength and length of exposure to the UVB therapy
Frequency of scheduled treatments
Documentation of training that includes ALL of the following
Demonstrated knowledge and ability to use the UVB therapy device ordered
Knowledge of side effects/ complications to be reported to the physician
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member’s health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
There is currently no evidence to recommend any one targeted or non-targeted NB-UVB device over another and the literature considers lasers and targeted UVB lamps to be equivalent devices. There is insufficient evidence to determine the value of or to support the use of phototherapy with PUVA or UVB therapies over conservative treatment as a first-line treatment for mild psoriasis, or to treat generalized psoriasis or psoriatic arthritis.
Individuals who require frequent treatments or those living in remote areas may require UVB therapy at home. Routine physician assessment is essential to assure the safety and efficacy of the home treatments. However, PUVA requires close physician supervision and should only be provided in the clinical setting and should not be done in the home.
Measurement tools to determine the severity and coverage of psoriasis include the Psoriasis Area and Severity Index (PASI) which is a measure of overall psoriasis severity and coverage that assesses body surface area (BSA), erythema, induration, and scaling. It is commonly used in clinical trials for psoriasis treatments but is rarely used in clinical practice. Another system is the Lattice System-Physician Global Assessment (PGA), where 1% of body surface area is approximately equal to the patient’s open handprint (from wrist to tips of fingers) with fingers tucked together and the thumb tucked to the side. In clinical practice, the physician generally uses subjective qualitative assessment of the severity of a patient’s psoriasis by combining objective assessment of the body surface area involvement, disease location, thickness, and symptoms, presence or absence of psoriatic arthritis with the subjective assessment of the physical, financial, and emotional impact of the disease on the patient’s life. The Physicians Global Assessment (PGA) another system is used with target plaque scores, and the percent of body surface area involvement particularly for those with milder disease. When using the Physicians Global Assessment, the investigator assigns a single estimate of the patients overall severity of disease; usually a 7-point scale from clear to severe.
SOURCES
111th Congress: 1st Session: HR. 2084: (2009, April). Prevention, awareness, and research of autoimmune disease act of 2009. Retrieved October 8, 2010 from http://thomas.loc.gov.
111th Congress: 1st Session: HR. 930: (2009, February). Psoriasis and psoriatic arthritis research, cure, and care act of 2009. Retrieved October 8, 2010 from http://thomas.loc.gov
111th Congress: 1st Session: S. 571: (2009, March). Psoriasis and psoriatic arthritis research, cure, and care act of 2009. Retrieved October 8, 2010 from http://thomas.loc.gov.
American Academy of Dermatology. (2009). Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 5. Guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy. Retrieved March 18, 2011 from http://www.aad.org/education-and-quality-care/clinical-guidelines/current-and-upcoming-guidelines/current-guidelines-and-guidelines-in-development.
BlueCross BlueShield Association. Medical Policy Reference Manual. (1 2011). Targeted phototherapy for psoriasis (2.01.47). Retrieved March 18, 2011 from BlueWeb. (17 articles and/or guidelines reviewed)
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Gawkrodger, D. J., Ormerod, A. D., Shaw, L., Mauri-Sole, I., Whitton, M. E., Watts, M. J., et al. (2008). Guideline for the diagnosis and management of vitiligo. British Journal of Dermatology, 159 (5), 1051-1076. (Level 5 Evidence)
Kumar, K., Rao, B., Gopal, K., Shanti, G., & Rao, K. (2009). Evaluation of narrow-band UVB phototherapy in 150 patients with vitiligo. Indian Journal of Dermatology Venereology and Leprology, 75 (2), 162 - 166. (Level 4 Evidence)
National Psoriasis Foundation. (2008, October). Light therapy. Retrieved September 21, 2010 from http://www.psoriasis.org/netcommunity/sublearn03_mild.
National Psoriasis Foundation. (2010). Psoriasis severity. Retrieved September 21, 2010 from http://www.psoriasis.org/netcommunity/sublearn03_mild.
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U. S. Food and Drug Administration. (2010, April). Center for Devices and Radiological Health. Code of Federal Regulations. Title 21, Volume 8. Section 878.4630. Ultraviolet lamb for dermatologic disorders. Retrieved March 31, 2011 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=878.4630.
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ORIGINAL EFFECTIVE DATE: 8/1983
MOST RECENT REVIEW DATE: 8/13/2011
ID_BT
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