|Subject:||Ultraviolet Light Therapy Delivery Devices for Home Use|
|Policy #:||DME.00036||Current Effective Date:||01/05/2016|
|Status:||Reviewed||Last Review Date:||11/05/2015|
This document addresses the use of home ultraviolet light (UV) therapy to treat various skin conditions.
Note: Please see the following document that addresses the treatment of skin conditions:
An in-home Ultraviolet B (UVB) light therapy delivery device is considered medically necessary for any of the following conditions:
WHEN the criteria below have been met:
Investigational and Not Medically Necessary:
An in-home UVB delivery device is considered investigational and not medically necessary for all other conditions not mentioned above, including but not limited to vitiligo, and when the criteria above are not met.
Home ultraviolet light therapy using ultraviolet A (UVA) light devices is considered investigational and not medically necessary for all indications.
The use of UV light therapy has been shown to provide significant health outcome improvements when used to treat a wide variety of skin disorders, including psoriasis. However, the use of UVA and UVB light therapy carries a significant risk of sunburn and increased skin cancer risk. The supervision of a physician is needed to make sure that the dose of UV light delivered to the treatment area is in the therapeutic range but does not exceed safe levels.
The majority of individuals undergoing UV treatment can be treated in the office. However, some individuals require treatments at a frequency that makes office visits overly burdensome. Home therapy with UVB light is an alternative. Concerns regarding over-exposure to unsafe levels of UVB radiation in the home setting have been addressed with the evolution of integrated security features such as keys, pass codes, etc. Routine clinical evaluation should be conducted to ensure that exposure is kept to the minimum level compatible with adequate control of disease and the prevention of complications.
Koek and colleagues (2009) conducted the first randomized controlled single-blind trial comparing office-based UVB treatment with home therapy for individuals with plaque or guttate psoriasis. This study involved 196 subjects who were evaluated through the initial therapy, with the first 105 subjects followed for an additional 12 months post-treatment. The authors reported that both treatments provided significant improvement from baseline, with home therapy being non-inferior to office based treatment as measured by the psoriasis area and severity index (PASI) and the self administered psoriasis area and severity index (SAPASI). No significant differences between groups were reported with regard to total cumulative radiation dose or short term side effects.
UVB has also been recommended as a treatment for several other conditions. Pityriasis lichenoides is a rare collection of skin disorders that have been reported to progress to cutaneous lymphoma or an ulceronecrotic presentation, both of which carry a significant risk of mortality. Treatment is difficult and aggressive approaches are usually recommended. According to one source, the use of UVB phototherapy has been the most successful treatment method and is considered first-line therapy (Khachemoune, 2007).
Pruritus of hepatic disease and renal failure are difficult to treat. Management is primarily focused on the treatment of the underlying symptoms such as pain and itching. There are several treatment options currently used, and the UVB phototherapy has become widely accepted as an important tool in the management of these conditions (Wang, 2010).
The evidence base regarding home-based UVA treatment for vitiligo is currently small and low quality. Shan and colleagues (2014) published early results of UVB home phototherapy for vitiligo in a prospective uncontrolled trial (n=93). Treatments were administered 3 times each week at variable dosages. Follow-up was conducted every 3 months up to 1 year to evaluate repigmentation and any complications. At 1 year of follow-up, 35 subjects (38%) achieved excellent repigmentation, 16 (17%) achieved good repigmentation, 15 (16%) showed moderate repigmentation, 16 (17%) had poor repigmentation, and 11 (12%) had no repigmentation. A total of 25 (27%) individuals discontinued treatment due to poor repigmentation. This study was hampered by several design limitations, including a lack of randomization, and lack of appropriate comparator groups.
Eleftheriadou (2014) conducted a pilot trial to determine the feasibility of conducting a multicenter randomized controlled trial (RCT) to assess the safety and effectiveness of home hand-held NB-UVB phototherapy compared with topical treatments for repigmentation of vitiligo. Results showed that a larger RCT evaluating home hand-held phototherapy is feasible and acceptable to participants and healthcare providers. This trial was not intended as an efficacy trial.
Additional well-designed RCTs are necessary to evaluate the safety and efficacy of home-based UVB phototherapy devices compared with in-office or alternative treatments for vitiligo.
UVA home therapy devices
The use of UVA as a home therapy has not been demonstrated to be a safe alternative to office or facility-based treatment. This is based upon the fact that UVA therapy is conducted with the use of photosensitizers, which greatly increase the risk of complications when compared to the use of UVB therapy, which does not involve the use of photosensitizers.
Psoriasis is a chronic skin disorder characterized by itching and/or a burning sensation in the affected area followed by various eruptions of the skin, which vary by the specific type of psoriasis.
Description of UV Light Therapy
UV light therapy is an established treatment for skin disorders that uses UV light, alone or in combination with topical preparations or oral medications, to treat various skin conditions. UV therapy involves exposure of the individual's skin to ultraviolet A (UVA) or UVB radiation using a specialized light source. As an alternative to UV therapy alone, some individuals respond to the Goeckerman or modified Goeckerman treatment, which is comprised of coal tar dressings in combination with exposure to UVB light.
UVB light can be categorized as wide-band and narrow-band, which refers to the range of wavelengths included in the UV light source. The wide-band devices deliver full spectrum UVB light. The narrow-band devices deliver a very narrow range of the UV light spectrum, focusing on the specific wavelengths most effective for the treatment of disease. Narrow-band UVB light can be delivered with either a light bulb or with a hand-held laser device. UVB treatment is typically offered using a light "booth" or "light box" several times a week for as long as the condition persists, which may be for the lifetime of the individual. In most cases an individual must go to a doctor's office or other facility for treatments. However, UVB treatment is available for home use under certain circumstances and under strict physician supervision.
UVA light is offered in conjunction with a photosensitizer called psoralen, and this combined approach may be referred to as photochemotherapy. Photosensitizers can be applied directly to the skin or taken orally and make the skin more sensitive to ultraviolet light. Photochemotherapy is used for more severe cases of skin diseases that fail to respond to topical therapy. One type of photochemotherapy known as PUVA (Psoralen with UVA) involves the topical or oral administration of psoralen (a potent photosensitizing drug), followed by exposure to varying doses of UVA light. The use of drugs and the higher risk of adverse reactions, including a higher risk of skin cancer, have generally limited PUVA therapy to the office setting.
Skin cancer, skin typing or phototesting is usually performed prior to treatment to determine the appropriate radiation dose. While high doses of UV light may result in faster clearing of the lesions, the normal skin surrounding lesions cannot tolerate such exposure and the risk of skin cancer is increased. Multiple sessions over 3 or more months are often required to produce clearing of skin lesions. During UV light therapy, individuals need regular medical assessments to evaluate the effectiveness of the therapy and to monitor for the development of side effects such as "sun burn" and pruritus (itching), skin cancer, photoaging, and liver or kidney disease.
Atopic dermatitis: The most common of many types of eczema; atopic dermatitis is a skin disease characterized by areas of severe itching, redness, scaling, and loss of the surface of the skin; when the eruption has been present for a prolonged time, chronic changes occur due to the constant scratching and rubbing.
Mycosis fungoides (Cutaneous T-cell lymphoma): A type of non-Hodgkin's lymphoma cancer that first appears on the skin.
Pityriasis lichenoides: A skin disorder of children and young adults that is characterized by a rash of unknown cause, which usually goes away on its own.
Plaque: A broad, raised area on the skin.
Pruritus: The medical term for itching.
Psoriasis: A genetic, systemic, inflammatory, chronic disorder, characterized by scaly, erythematous patches, papules, and plaques that are often pruritic (itchiness). It is commonly located over the surfaces of the elbows, knees, scalp, and around or in the ears, navel, genitals or buttocks, but may appear elsewhere. It can be altered by environmental factors and may be associated with other inflammatory disorders such as psoriatic arthritis, inflammatory bowel disease, and coronary artery disease. The major manifestation of psoriasis is chronic inflammation of the skin that may be disfiguring, painful and severely pruritic and may cause significant quality of life issues. Psoriasis is a chronic disease that waxes and wanes during an individual's lifetime, the severity of which changes by treatment initiation and cessation. Some individuals can undergo spontaneous remissions.
Vitiligo: A skin disorder that causes loss of pigmentation (skin color) in blotches. The disorder affects the skin on any part of the body, including the hair, inside of the mouth, and eyes.
Ultraviolet (UV) light: Also known as UV light. This is a form of light invisible to the human eye that naturally comes from the sun but can also be produced by artificial light sources such as tanning lamps. Three types UV light exist: ultraviolet A (UVA), ultraviolet B (UVB), and ultraviolet C (UVC).
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
When services may be Medically Necessary, when criteria are met:
|E0691||Ultraviolet light therapy system, includes bulbs/lamps, timer and eye protection; treatment area 2 square feet or less [when specified as UVB]|
|E0692||Ultraviolet light therapy system panel, includes bulbs/lamps, timer and eye protection, 4 foot panel [when specified as UVB]|
|E0693||Ultraviolet light therapy system panel, includes bulbs/lamps, timer and eye protection, 6 foot panel [when specified as UVB]|
|E0694||Ultraviolet multidirectional light therapy system in 6 foot cabinet, includes bulbs/lamps, timer and eye protection [when specified as UVB]|
|K73.0-K73.9||Chronic hepatitis, not elsewhere classified|
|K74.0-K74.69||Fibrosis and cirrhosis of liver|
|K75.0-K75.9||Other inflammatory liver diseases|
|L41.0||Pityriasis lichenoides et varioliformis acuta|
|L41.1||Pityriasis lichenoides chronica|
|N03.0-N03.9||Chronic nephritic syndrome|
|N18.1-N18.9||Chronic kidney disease (CKD)|
When services are Investigational and Not Medically Necessary:
For the procedure codes listed above specified as UVB when criteria are not met or for all other diagnoses not listed, for UVA panels for all diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Websites for Additional Information|
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
|Reviewed||11/05/2015||Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Background/Overview, References and Index sections. Removed ICD-9 codes from Coding section.|
|Reviewed||11/13/2014||MPTAC review. Updated Rationale and Reference sections.|
|Reviewed||11/14/2013||MPTAC review. Updated Reference section.|
|Reviewed||11/08/2012||MPTAC review. Updated Coding and Reference sections.|
|01/01/2012||Updated Coding section with 01/01/2012 HCPCS descriptor revisions.|
|Revised||11/17/2011||MPTAC review. Changed the document # from MED.00008 to DME.00036. Revised title from "Light therapy, Including Ultraviolet Light, Ultraviolet Laser and Visible Light Laser, for the Treatment of Skin Disorders" to "Ultraviolet Light Therapy Delivery Devices for Home Use". Position statement now limited to home use of UV light therapy. Updated Scope, Rationale, Background, Definitions, Coding, Reference, and Index sections.|
|Revised||02/17/2011||MPTAC review. Revised title from "Ultraviolet Light, Including Laser Therapy, for the Treatment of Skin Disorders" to "Light therapy, Including Ultraviolet Light, Ultraviolet Laser and Visible Light Laser, for the Treatment of Skin Disorders". Added the use of visible light laser (e.g., pulsed dye laser) therapy for the treatment of all skin conditions as investigational and not medically necessary. Updated Rationale Definitions, Coding, Reference, and Index sections.|
|Reviewed||11/18/2010||MPTAC review. Updated Rationale and Reference sections.|
|Reviewed||11/29/2007||MPTAC review. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary."|
|Revised||08/23/2007||MPTAC review. Revised the medically necessary statement regarding ultraviolet B laser therapy for the treatment of psoriasis to add "or equal to" to body surface are criteria. Updated Reference section.|
|Revised||12/07/2006||MPTAC review. Added vitiligo as medically necessary indication for UVB therapy; updated Reference section.|
|Reviewed||06/08/2006||MPTAC review. Updated references.|
|11/22/2005||Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).|
|Revised||07/14/2005||MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.|
|Pre-Merger Organizations||Last Review Date||Document Number||Title|
|Anthem, Inc.||04/28/2005||MED.00008||Ultraviolet Light, Including Laser Therapy, for the Treatment of Skin Disorders|
|WellPoint Health Networks, Inc.||09/23/2004||2.02.08||Psoralens Ultraviolet A Light Therapy (PUVA Therapy)|
|04/28/2005||2.02.09||Treatment of Psoriasis with Excimer Laser|