Clinical UM Guideline

 

Subject: Ultraviolet Light Therapy Delivery Devices for Home Use
Guideline #: CG-DME-41 Publish Date:    12/27/2017
Status: New Last Review Date:    11/02/2017

Description

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:

Clinical Indications

Medically Necessary:

An in-home Ultraviolet B (UVB) light therapy delivery device is considered medically necessary when conditions A and B are met:

  1. The treatment is for one of the following conditions:
    1. Atopic dermatitis, when topical treatment alone has failed; or
    2. Pityriasis lichenoides; or
    3. Pruritus of hepatic disease; or
    4. Pruritus of renal failure; or
    5. Psoriasis, when topical treatment alone has failed; or
    6. Cutaneous T-cell lymphoma including mycosis fungoides and Sézary syndrome.

and

  1. The treatment meets the all of the following criteria:
    1. Treatment is conducted under a physician’s supervision with regularly scheduled exams; and
    2. Treatment is expected to be long term (3 months or longer); and
    3. The individual meets any of the following:
      1. The individual is unable to attend office-based therapy due to a serious medical or physical condition (for example, confined to the home, leaving home requires special services or involves unreasonable risk); or
      2. Office based therapy has failed to control the disease and it is likely that home based therapy will be successful; or
      3. The individual suffers from severe psoriasis with a history of frequent flares which require immediate treatment to control the disease.

Not Medically Necessary:

An in-home UVB delivery device is considered 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 are considered not medically necessary for all indications.

Coding

The following codes for treatments and procedures applicable to this guideline 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.

HCPCS

 

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]

 

 

ICD-10 Diagnosis

 

C84.00-C84.09

Mycosis fungoides

C84.10-C84.19

Sézary disease

C86.6

Primary cutaneous CD30-positive T-cell proliferations

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

L20.0-L20.9

Atopic dermatitis

L29.0-L29.9

Pruritus

L40.0-L40.9

Psoriasis

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)

Discussion/General Information

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 disorders. 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.

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. 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.

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. As with UVB therapy performed in the office, routine clinical evaluation should be conducted on home therapy individuals to ensure that exposure is kept to the minimum level compatible with adequate control of disease and the prevention of complications.

Atopic dermatitis (AD)

The initial treatment of AD typically consists of topical and non -pharmacological therapies as well as modifications in individual environments or occupations. Phototherapy is limited to those whose symptoms are not adequately controlled by the initial treatment modalities. There are numerous treatment protocols, but in general, individuals are dosed according to their minimal erythema dose and/or Fitzpatrick skin type. The AAD (2014) notes “Phototherapy can be administered on a scheduled but intermittent basis over time, or more continuously as maintenance therapy, for patients with refractory or chronic disease.”

Cutaneous T-cell lymphoma (CTCL)

NHL includes two types of cutaneous lymphomas, T-cell lymphomas (CTCLs) and B-cell lymphomas (CBCLs), with CTCLs accounting for the majority of cutaneous lymphomas. According to the NCCN CPG for T-cell Lymphomas, MF accounts for 50% to 70% of CTCL cases and SS accounts for only 1% to 3% of CTCL cases (2016). MF is considered an indolent malignancy and generally is associated with a slow progression while the median survival of SS is only 32 months from diagnosis (Trautinger, 2006). While CTCLs develop in the skin, the disease can progress and involve other areas such as lymph nodes, blood or visceral organs. Prognosis and treatment are dependent upon a number of factors including, but not limited to extent and type of skin involvement, overall stage, whether extracutaneous disease is present and peripheral blood involvement (NCCN, 2017).

Mycosis Fungoides (MF) and Sézary syndrome (SS)

Ultraviolet light therapy is an established treatment of MF and therapies have included UVB (broad-band and narrow-band) and UVA treatments (Hodak, 2015). Phototherapy can be used at various stages of MF, either alone or in combination with systemic therapy (Hodak, 2015). The 2017 National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines (CPGs) in Oncology® for T-cell Lymphoma include a 2A indication for UVB therapy for patch/thin plaques in MF/SS with limited/localized or generalized skin involvement. In addition, NCCN includes a 2A indication for UVB in stage III MF/SS, noting that while generalized skin directed therapies may not be well tolerated in this population, phototherapy can be used successfully.

Due to the low incidence of MF, there is a dearth of appropriately powered RCTs and most recommendations are generally based upon small studies, case series or expert opinion. Olsen and colleagues reported on the results of three studies which included home broad-based UVB therapy which consisted of a total of 109 individuals who presented with stage 1A or 1B MF. Home treatments included daily phototherapy while office-based treatments were carried out 3 times per week. A total of 58 individuals received home-based therapy, with 48 of these 58 individuals receiving only home-based therapy and the remaining 10 individuals receiving home therapy after office-based therapy. The authors noted that maintenance regimens within the studies varied and likely affected response duration. Relapse was uncommon while individuals were on maintenance phototherapy (2/18), but was more common once maintenance phototherapy was discontinued (12/23). The authors found that individuals using home-based phototherapy were much more likely to continue maintenance phototherapy than individuals who received office-based phototherapy.

Pityriasis lichenoides

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 or renal disease

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. Several treatment options are currently used, and UVB phototherapy has become widely accepted as an important tool in the management of these conditions (Wang, 2010).

Psoriasis

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.

Vitiligo

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.

The current evidence does not support the safety and efficacy of home-based UVB phototherapy devices compared with in-office or alternative treatments for vitiligo. The published literature does not show that use of a home-based UVB phototherapy device provides additional benefits to the individual user.

UVA home therapy devices

The use of UVA as a home therapy has not been shown to be safe and effective when compared to the other alternatives, such as office or facility-based treatment UVA therapy or UVB therapy. The AAD (2014) notes that given the limited number of head-to-head trials, there is no definitive recommendation regarding which form of phototherapy is more effective. UVA therapy requires the concurrent use of photosensitizers, which greatly increase the risk of complications. UVB therapy does not involve the use of photosensitizers.

Definitions

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).

References

Peer Reviewed Publications:

  1. Abel EA. Considerations in the use of home ultraviolet radiation therapy for psoriasis. Cutis. 1985; 35(2):127-128, 130.
  2. Eleftheriadou V, Thomas K, Ravenscroft J, et al. Feasibility, double-blind, randomized, placebo-controlled, multi-centre trial of hand-held NB-UVB phototherapy for the treatment of vitiligo at home (HI-Light trials: Home Intervention of Light Therapy). Trials. 2014; 15:51.
  3. Feldman SR, Clark A, Reboussin DM, Fleischer AB Jr. An assessment of potential problems of home phototherapy treatment of psoriasis. Cutis. 1996; 58(1):7-13.
  4. Fleischer AB Jr, Clark AR, Rapp SR, et al. Commercial tanning bed treatment is an effective psoriasis treatment: results from an uncontrolled clinical trial. J Invest Dermatol. 1997; 109(2):170-174.
  5. Hallaji Z, Barzegari M, Balighi K, et al. A comparison of three times vs. five times weekly narrowband ultraviolet B phototherapy for the treatment of chronic plaque psoriasis. Photodermatol Photoimmunol Photomed. 2010; 26(1):10-15.
  6. Hodak E, Pavlovsky L. Phototherapy of Mycosis Fungoides. Dermatol Clin. 2015; 33(4):697-702.
  7. Hung R, Ungureanu S, Edwards C, et al. Home phototherapy for psoriasis: a review and update. Clin Exp Dermatol. 2015; 40(8):827-832.
  8. Khachemoune A, Blyumin ML. Pityriasis lichenoides: pathophysiology, classification, and treatment. Am J Clin Dermatol. 2007; 8(1):29-36.
  9. Kleinpenning MM, Smits T, Boezeman J, et al. Narrowband ultraviolet B therapy in psoriasis: randomized double-blind comparison of high-dose and low-dose irradiation regimens. Br J Dermatol. 2009; 161(6):1351-1356.
  10. Koek MB, Buskens E, van Weelden H, et al. Home versus outpatient ultraviolet B phototherapy for mild to severe psoriasis: pragmatic multicentre randomized controlled non-inferiority trial (PLUTO study). BMJ. 2009; 338:b1542.
  11. Poligone B, Heald P. Menus for managing patients with cutaneous T-cell lymphoma. Semin Cutan Med Surg. 2012; 31(1):25-32.
  12. Resnik KS, Vonderheid EC. Home UV phototherapy of early mycosis fungoides: long-term follow-up observations in thirty-one patients. J Am Acad Dermatol. 1993; 29(1):73-77.
  13. Shan X, Wang C, Tian H, et al. Narrow-band ultraviolet B home phototherapy in vitiligo. Indian J Dermatol Venereol Leprol. 2014; 80(4):336-338.
  14. Wang H, Yosipovitch G. New insights into the pathophysiology and treatment of chronic itch in patients with end-stage renal disease, chronic liver disease and Lymphoma. Int J Dermatol. 2010; 49(1):1-11.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Akdis CA, Akdis M, Bieber T, et al.; European Academy of Allergology and Clinical Immunology/American Academy of Allergy, Asthma and Immunology/PRACTALL Consensus Group. Diagnosis and treatment of atopic dermatitis in children and adults: European Academy of Allergology and Clinical Immunology/American Academy of Allergy, Asthma and Immunology/PRACTALL Consensus Report. Allergy. 2006; 61(8):969-987.
  2. Arkwright PD, Motala C, Subramanian H, et al.; Atopic Dermatitis Working Group of the Allergic Skin Diseases Committee of the AAAAI. Management of difficult-to-treat atopic dermatitis. J Allergy Clin Immunol Pract. 2013; 1(2):142-151.
  3. Centers for Medicare and Medicaid Services. National Coverage Determinations. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed September 20, 2017.
    • NCD for Treatment of Psoriasis. NCD #250.1. Effective date not available.
  4. Leung DY, Nicklas RA, Li JT, et al. Disease management of atopic dermatitis: an updated practice parameter. Joint Task Force on Practice Parameters. Ann Allergy Asthma Immunol. 2004; 93(3 Suppl 2):S1-S21.
  5. Menter A, Korman NJ, Elmets CA, et al. 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. J Am Acad Dermatol. 2010; 62(1):114-135.
  6. National Cancer Institute (NCI). Mycosis Fungoides (Including Sézary Syndrome) Treatment (PDQ®). Last modified July 12, 2017. Accessed on September 20, 2017.
  7. NCCN Clinical Practice Guidelines in Oncology® (NCCN). © 2017 National Comprehensive Cancer Network, Inc. T-cell Lymphomas. V.2.2017. Revised February 21, 2017. For additional information: http://www.nccn.org/index.asp. Accessed on September 20, 2017.
  8. Olsen EA, Hodak E, Anderson T, et al. Guidelines for phototherapy of mycosis fungoides and Sézary syndrome: a consensus statement of the United States Cutaneous Lymphoma Consortium. J Am Acad Dermatol. 2016; 74(1):27-58.
  9. Sidbury R, Davis DM, Cohen DE, et al.; American Academy of Dermatology. Guidelines of care for the management of atopic dermatitis: section 3. Management and treatment with phototherapy and systemic agents. J Am Acad Dermatol. 2014; 71(2):327-349.
  10. Trautinger F, Knobler R, Willemze R, et al. EORTC consensus recommendations for the treatment of mycosis fungoides/Sézary syndrome. Eur J Cancer. 2006; 42(8):1014-1030.
Websites for Additional Information
  1. American Academy of Dermatology. Available at: http://www.aad.org. Accessed on October 3, 2017.
  2. National Center for Advancing Translational Sciences. Cutaneous T-cell lymphoma. Updated September 27, 2011. Available at: https://rarediseases.info.nih.gov/diseases/6226/cutaneous-t-cell-lymphoma. Accessed on October 3, 2017.
  3. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Available at: http://www.niams.nih.gov/. Accessed on October 3, 2017.
  4. National Psoriasis Foundation. Available at: http://www.psoriasis.org. Accessed on October 3, 2017.
Index

Daavlin
DermaLume 2X
Handisol II®
National Biological Phototherapy
Panosol II®
Panosol 3D®
Phototherapy
Psoriasis
SolarC Systems
UVBioTek

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.

History

Status

Date

Action

New

11/02/2017

Medical Policy & Technology Assessment Committee (MPTAC) review.

New

11/01/2017

Hematology/Oncology Subcommittee review. Initial document development. Moved content of DME.00036 Ultraviolet Light Therapy Delivery Devices for Home Use to new clinical utilization management guideline document with the same title.