National Medical Policy Subject: Phototherapy and Photochemotherapy (PUVA) For Dermatological Conditions (Refer to the Health Net National Medical Policy Phototherapy for Psoriasis for additional information) Policy Number: NMP441 Effective Date*: November 2008 Updated: January 2015 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for, coverage guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use X Source National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* Other None Reference/Website Link Skin Lesion Removal (Includes AK and Excludes MOHS): http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under “Reference/Website” and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. Phototherapy and Photochemotherapy (PUVA) for Dermatological Conditions Jan 15 1 If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Health Net, Inc. considers phototherapy with Ultraviolet A or B therapy or photochemotherapy (PUVA) medically necessary when there has been a failure or contraindication to treatment using conventional therapy for any of the following medical conditions: Severe atopic dermatitis (atopic eczema); or Severe lichen planus; or Severe photodermatoses (e.g., polymorphic light eruption, actinic prurigo, chronic actinic dermatitis); or Cutaneous T cell lymphoma (early stage mycosis fungoides); or Severe large plaque parapsoriasis; or Sclerotic Skin Diseases (e.g., Localized scleroderma, eosinophilic fasciitis, chronic graft-versus-host disease, lichen sclerosus et atrophicus, scleredema adultorum, necrobiosis lipoidica, POEMS disease, pansclerotic porphyria cutanea tarda, and drug-induced scleroderma-like disorders); or Health Net, Inc. considers Ultraviolet B (UVB) radiation (phototherapy) or topical or oral psoralen ultraviolet A (photochemotherapy or PUVA) medically necessary for the treatment of Vitiligo. Refer to the Health Net Medical Policy on Vitiligo Treatment NMP32 for additional information. Abbreviations UV UVA UVB PUVA BB-UVB NB-UVB GVHD IFN-y SLEDAI SLAM PL PLEVA PLC Ultraviolet Radiation Ultraviolet Type A Radiation Ultraviolet Type B Radiation Combination of psoralen (P) and long-wave ultraviolet radiation (UVA) Broad Band Ultraviolet Type B Radiation Narrow Band Ultraviolet Type B Radiation Graft versus Host Disease Intracytoplasmic interferon y SLE Disease Activity Index SLE Activity Measure Pityriasis Lichenoides Pityriasis Lichenoides et Varioliformis Acuta Pityriasis Lichenoides Chronica Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this Phototherapy and Photochemotherapy (PUVA) for Dermatological Conditions Jan 15 2 transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2015 implementation date. ICD-9 Codes 202.1 691 691.8 692 692.9 696.2 697.0 701 701.0 709.1 709.9 Mycosis fungoides (T-cell lymphoma) Atopic dermatitis and related conditions Other atopic dermatitis and related conditions [severe refractory] Contact dermatitis and other eczema Contact dermatitis and eczema of unspecified cause Parapsoriasis Lichen Planus Other hypertrophic and atrophic conditions of skin Circumscribed scleroderma Vitiligo Unspecified disorder of skin or subcutaneous tissue (dermatoses NOS) ICD-10 Codes C84.00C84.09 H02.731H02.739 L20.0L20.9 L23.0L23.9 L24.0L24.9 L25.0L25.9 L30.9 L41.0L41.9 L43.0L43.9 L80 L94.0 L98.9 Mycosis fungoides Vitiligo of eyelid and periocular area Atopic dermatitis Allergic contact dermatitis Irritant contact dermatitis Unspecified contact dermatitis Dermatitis, unspecified Parapsoriasis Lichens planus Vitiligo Localized scleroderma [morphea] Disorder of the skin and subcutaneous tissue, unspecified CPT Codes 96567 96910 96912 96913 Photodynamic therapy by external application of light to destroy premalignant and/or malignant lesions of the skin and adjacent mucosal (Eg. lip) by activation of photosensitive drug9(s), each phototherapy session. Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or petrolatum and ultraviolet B Photochemotherapy; psoralens and ultraviolet A (PUVA) Photochemotherapy (Goeckerman and/or PUVA) for severe photoresponsive dermatoses requiring at least four to eight hours of care under direct supervision of the physician (includes application of medication and dressings) (when specified as PUVA) Phototherapy and Photochemotherapy (PUVA) for Dermatological Conditions Jan 15 3 HCPCS Codes A4633 E0691 E0692 E0693 E0694 Replacement bulb/lamp for ultraviolet light therapy system, each Ultraviolet light therapy system panel, includes bulbs/lamps, timer, and eye protection; treatment area two square feet or less Ultraviolet light therapy system panel, includes bulbs/lamps, timer, and eye protection, four foot panel Ultraviolet light therapy system panel, includes bulbs/lamps, timer, and eye protection, six foot panel Ultraviolet multidirectional light therapy system in 6 foot cabinet, includes bulbs/lamps, timer, and eye protection Scientific Rationale – Update March 2011 Phototherapy is defined as exposure to nonionizing radiation for therapeutic benefit. It can encompass the use of visible light, photodynamic therapy (PDT), photothermolysis, and laser therapy. More specifically, visible light phototherapy utilizes ultraviolet-free light within the visible spectrum, such as blue and red visible light, with wavelengths spanning 415 to 660 nm. PDT is characterized by the use of visible light in addition to a topical application of photosensitizers, such as commonly used agent, 5-aminolevulinic acid (ALA) and its methyl ester (MAL). Another type of phototherapy is photothermolysis, which uses both light and heat energy with broadband intense pulsed light (IPL). Near-infrared lasers with 1320- to 1540-nm wavelengths are also used. Other laser types used are pulsed dye laser (PDL), longPDL, argon laser, and diode laser. It has been suggested that solar, artificial ultraviolet (UV), and psoralen plus ultraviolet A (PUVA) light should no longer be employed for phototherapy acne treatment due their low efficacy and their potential carcinogenic and photoaging effects. According to the National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) booklet Handout on Health: Atopic Dermatitis (2009): “Atopic dermatitis is a chronic (long-lasting) disease that affects the skin. It is not contagious; it cannot be passed from one person to another. The word “dermatitis” means inflammation of the skin. “Atopic” refers to a group of diseases in which there is often an inherited tendency to develop other allergic conditions, such as asthma and hay fever. In atopic dermatitis, the skin becomes extremely itchy. Scratching leads to redness, swelling, cracking, “weeping” clear fluid, and finally, crusting and scaling. In most cases, there are exacerbations followed by remissions. As some children with atopic dermatitis grow older, their skin disease improves or disappears altogether, although their skin often remains dry and easily irritated. In others, atopic dermatitis continues to be a significant problem in adulthood. Atopic dermatitis is often referred to as “eczema,” which is a general term for the several types of inflammation of the skin. Atopic dermatitis is the most common of the many types of eczema. Treatment of atopic dermatitis includes the use of ultraviolet A or B light waves, alone or combined, which can be an effective treatment for mild to moderate dermatitis in older children (over 12 years old) and adults. A combination of ultraviolet light therapy and a drug called psoralen can also be used in cases that are resistant to ultraviolet light alone. Tzaneva et al. (2010) completed a randomized observer-blinded crossover trial with 40 patients, to compare UVA1 and oral 5-methoxypsoralen (5-MOP) plus UVA with respect to efficacy, tolerability and duration of response in patients with severe generalized atopic dermatitis (AD). The patients received either 15 exposures to medium-dose UVA1 as the first treatment and, in cases of relapse, another 15 exposures to 5-MOP plus UVA as the second treatment, or vice versa. All patients were followed until 12 months after discontinuation of the last treatment. The SCORAD score was determined by a blinded investigator at baseline, after 10 and 15 Phototherapy and Photochemotherapy (PUVA) for Dermatological Conditions Jan 15 4 treatments each and during the follow-up period. In addition, all adverse events were recorded during the whole study period. Twenty-three patients completed the crossover treatment. Both phototherapies resulted in clinical improvement; however, PUVA reduced the baseline SCORAD score to a significantly greater extent than UVA1 (mean +/- SD 543 +/- 257% vs. 377 +/- 228%; P = 0041). The median length of remission was 4 weeks (interquartile range 4-12) after UVA1 and 12 weeks (interquartile range 4-26) after PUVA therapy (P = 0012). PUVA provides a better short- and long-term response than medium-dose UVA1 in patients with severe AD. Scientific Rationale – Update January 2010 Vitiligo is an acquired skin depigmentation that produces white patches and can affect any part of the body. Generalized vitiligo is the most common and usually involves the face, lips, hands, arms, legs, and genital areas. Both sides of the body are usually affected. Vitiligo can be psychologically devastating, especially when present on visible areas of the body, such as the face and hands. The etiology of vitiligo is unclear although it is believed to be an autoimmune disorder. The goal of treatment is to restore the skin's color by restoring healthy melanocytes to the skin (repigmentation) allowing the skin to regain its normal appearance. Individuals with vitiligo should always protect their depigmented skin against excessive sun exposure by wearing protective clothing, applying a UVA/UVB sunscreen daily, and avoid prolonged sun exposure. Treatments have highly variable results; therefore, treatment modalities should be selected for maximum benefit and minimum risk, with consideration for the body surface area involved. Topical corticosteroids are often used as first-line therapy. Topical tacrolimus has shown efficacy in some trials and has the advantage over topical corticosteroids as it does not cause skin atrophy. Tacrolimus often works best when combined with NB-UVB light. Topical and oral psoralen ultraviolet A (PUVA) and photochemotherapy or phototherapy with Ultraviolet A or B therapy have good success rate. PUVA is effective for the face, trunk, upper arms, and upper legs. NBUVB requires two to three treatment sessions per week for several months. Many studies of treatments for vitiligo are of poor quality and so evidence is limited, particularly for the long-term benefits and safety of therapies. Welsh et al (2009) evaluated the repigmentation response induced with broadband, UVB-targeted phototherapy used as monotherapy in twelve patients with vitiligo affecting less than 10% of the skin surface. Patients were treated with 30 sessions of UVB-targeted phototherapy administered twice weekly. The assessment of repigmentation was made from a comparison of baseline photographs with those after 30 sessions by two independent investigators. Morphometric analysis was performed using a computer program. The authors reported that repigmentation with an average of 66.25% was obtained on lesions of the face, and of 31.5% on the neck, trunk, and genitalia. On the extremities, there was no repigmentation. Itching, a burning sensation, erythema, desquamation, and transitory hyperpigmentation were observed in some patients. Minimal blistering and ulceration were observed in one patient. They concluded that targeted UVB phototherapy seems to be effective for the repigmentation of vitiligo in lesions located on the face, to a lesser degree on the trunk, and with no response in acral lesions. Minimal adverse effects that did not require discontinuation of treatment were reported. A Cochrane review of all interventions for the treatment of vitiligo, reported by Whitton et al (2008), identified nineteen randomized controlled trials. At least two reviewers independently assessed study eligibility, methodological quality, and extracted data. The authors concluded that variations in study design and different outcome measures limit the evidence for the different therapeutic options. The best evidence from individual trials showed short-term benefit from topical steroids and Phototherapy and Photochemotherapy (PUVA) for Dermatological Conditions Jan 15 5 various forms of UV light with topical preparations. They reported that long-term follow-up and patient-centered outcomes should be incorporated in study design and psychologic interventions need more attention. Asawanonda et al (2008) compared the repigmenting efficacy of targeted broadband UVB phototherapy with that of NB-UVB in a small number of patients with skin types III, IV and V. Twenty identical vitiliginous lesions from 10 patients were randomly allocated to receive either targeted broadband UVB or targeted NB-UVB phototherapy. UV fluences were started at 50% of the minimal erythema dose detected within the vitiliginous patches, then increased gradually, in the same manner, to ensure equi-erythemogenic comparison. Treatments were carried out twice weekly for 12 weeks. The results show that grade 1, i.e. 1-25% repigmentation, to grade 2, 26-50% repigmentation, occurred in 6 of 10 subjects. Responses in terms of repigmentation, de-pigmentation, or lack thereof, were similar between lesions receiving broadband and NB-UVB phototherapy. Onset of repigmentation occurred as early as 4 weeks of treatment in most subjects. Treatments were well tolerated, with only minimal erythema and hyperpigmentation. Bhatnagar et al (2007) compared the phototherapy modalities PUVA and NBUVB in inducing stability in vitiligo, assessed by using vitiligo disease activity score (VIDA), in an open prospective study of 50 individuals divided equally between the two groups. In the NBUVB group, disease activity was present in 40% patients before commencement of therapy, which was reduced to 16% at the end of therapy. In the PUVA group, similar figures were 20% and 16%, respectively. In the NBUVB group, 50% of patients whose disease was active prior to commencement of therapy had less than 50% repigmentation, whereas an equal number of patients had repigmentation of more than 50%. Almost an equal number of stable patients had less than and more than 50% repigmentation. In the PUVA group, 4 of the 5 (80%) patients who had active disease had less than 50% repigmentation, whereas only 1 patient (20%) with active disease obtained more than 50% repigmentation. The time to attain stability was 3.6 +/- 2.1 months in the NBUVB group and 3.22 +/- 3.1 months in the PUVA group. Eight of the 10 (80%) patients with unstable disease in the NBUVB group achieved stability, whereas 2 of the 5 (40%) patients of similar pre-treatment status in the PUVA group achieved stability. Yones et al (2007) compared the efficacy of oral psoralen-UV-A (PUVA) with that of narrowband-UV-B (NB-UVB) phototherapy in 56 patients with nonsegmental vitiligo. The results in the 25 patients each in the PUVA and NB-UVB groups who began therapy were analyzed. The median number of treatments was 47 in the PUVAtreated group and 97 in the NB-UVB-treated group. The author suggested that this difference was because of the differences in efficacy and adverse effects between the 2 modalities, such that patients in the NB-UVB group wanted a longer course of treatment. At the end of therapy, 16 (64%) of 25 patients in the NB-UVB group showed greater than 50% improvement in body surface area affected compared with 9 (36%) of 25 patients in the PUVA group. The color match of the repigmented skin was excellent in all patients in the NB-UVB group but in only 11 (44%) of those in the PUVA group. In patients who completed 48 sessions, the improvement in body surface area affected by vitiligo was greater with NB-UVB therapy than with PUVA therapy. Twelve months after the cessation of therapy, the superiority of NB-UVB tended to be maintained. Scientific Rationale Initial Phototherapy treatments used for specific skin conditions include all of the following: Type A ultraviolet (UVA) radiation; Phototherapy and Photochemotherapy (PUVA) for Dermatological Conditions Jan 15 6 Type B ultraviolet (UVB) radiation; and UVB light can be categorized as wide-band and narrow-band, which refers to the wavelengths included in the UV light source. Phototherapy utilizes UVB treatments can also be combined with coal tar applications, known as the Goeckerman regimen. Combination UVA/UVB radiation. Photochemotherapy includes psoralens (P) and type A ultraviolet (UVA) radiation, known as PUVA photochemotherapy and combinations of P/UVA/UVB. Photochemotherapy utilizes UVA in conjunction with a photosensitizer called psoralen (also known as psoralen with Ultraviolet A, or PUVA for short). The photosensitizer known as psoralen is a medication that can be applied directly to the skin or taken orally and makes the skin more sensitive to the ultraviolet light. Examples of phototherapy and photochemotherapy devices include, but may not be limited to, Multiclear XL, ClearLight, Derma-Wand, Phototherapeutix, Daavlin Ultraviolet Phototherapy Cabinet, TheraLight, and Lumenis BClear UVB Phototherapy System. Atopic Dermatitis (Eczema) Dermatitis is as an inflammation of the skin and includes a wide variety of skin disorders, including atopic dermatitis (eczema), seborrheic dermatitis, contact dermatitis, latex dermatitis and allergy, and dyshidrotic dermatitis. Depending upon the underlying cause, dermatitis can be a short-term or lifelong condition. Eliminating factors that worsen eczema can effectively control the symptoms, in most scenarios. Aggravating factors may include frequent bathing and dry environments (which can further dry the skin), emotional stress, rapid temperature changes, and exposure to certain chemicals and cleaning solutions. Common irritants include soaps and detergents, perfumes and cosmetics, wool or synthetic fibers, dust, sand, and cigarette smoke. Ultraviolet light therapy or phototherapy can effectively control atopic dermatitis. However, this therapy may increase a person's risk for skin cancer, and is therefore recommended only for people with severe eczema who do not respond to discontinuing the triggers noted above. (2007) The National Institute for Clinical Excellence (NICE) published a report on the treatment of atopic eczema in children up to age 12 years. The Guidance Development Group concluded that phototherapy should only be considered for the treatment of severe atopic eczema in children when other management options have failed or are inappropriate and where there is a significant negative impact on quality of life. The American Academy of Dermatology (AAD) Practice Management "Guidelines of Care for Atopic Dermatitis" includes phototherapy recommendations for atopic dermatitis. These care guidelines are based upon a systematic review of literature dated from 1990 to June 2003. Generally, the atopic dermatitis guidelines recommend treatment with UV phototherapy, including combination BB-UVB/UVA, nbUVB, PUVA and UVA (Hanifin, et al., 2004). Phototherapy and Photochemotherapy (PUVA) for Dermatological Conditions Jan 15 7 (2004) Guidelines developed by the Joint Task Force on Practice Parameters for Allergy and Immunology, which is sponsored by the American Academy of Allergy, Asthma, and Immunology, the American College of Allergy, Asthma, and Immunology and the Joint Council of Allergy, Asthma and Immunology state: “When atopic dermatitis is either severe or has not responded to appropriate first-line management strategies, specialist consultation should be obtained. This allows both a reevaluation of first-line treatment approaches (e.g., hydration, emollients, topical corticosteroids, pimecrolimus, tacrolimus, and tar preparations) and consideration of alternative therapy. Examples of alternative strategies include (1) the application of wet dressings in combination with topical corticosteroids; (2) short-term treatment with systemic corticosteroids with appropriate tapering to avoid rebound; (3) phototherapy with ultraviolet light (UV-B or UV-A [PUVA]); (4) immunomodulatory or immunosuppressive agents; (5) hospitalization to separate the patient from environmental allergens while administering other therapies; and (6) allergen immunotherapy when aeroallergens are clearly implicated in dermatitis flares.” Lichen planus Lichen planus is a dermatological disease of unknown etiology affecting the skin and oral mucous membranes, either alone or concomitantly. The oral lesions are most common on the buccal mucous membrane. Histologically, lichen planus is characterized by dense lymphocytic infiltrate at the dermal-epidermal junction. The infiltrates consist of predominantly T cells, a finding suggesting the pathogenic role of cell-mediated immunity. The following treatment options for lichen planus are available: Topical corticosteroids are helpful in patients with limited disease, and those with oral lesions; A 6- to 8-week course of oral corticosteroids is helpful in patients with widespread lichen planus; NB-UVB phototherapy or PUVA is helpful for widespread conditions. Aydogan et al. (2008) Narrowband (NB-UVB) phototherapy has recently demonstrated high levels of efficacy and tolerability in a variety of skin diseases. The purpose of the present study was to assess the efficacy of NB-UVB phototherapy in the management of pityriasis lichenoides (PL). The therapeutic response in 31 PL patients treated with NB-UVB phototherapy between 2000 and 2007 was assessed. NB-UVB treatment led to a complete response (CR) in 15 out of 23 individuals with pityriasis lichenoides et varioliformis acuta (PLEVA) (65.2%) and a partial response in eight patients (34.8%). NB-UVB treatment led to CR in seven out of eight patients with pityriasis lichenoides chronica (PLC) (87.5%). Relapses occurred in four PL patients within a mean time period of 6 months. NB-UVB therapy is an effective, safe and practical alternative treatment modality for the management of PLEVA and PLC. Photodermatoses (e.g., polymorphic light eruption, actinic prurigo, chronic actinic dermatitis) Photodermatoses indicate the development of cutaneous eruption secondary to exposure to UV or visible radiation. UVB, UVA, and visible light are the relevant spectra in photodermatoses. Polymorphous light eruption is the most common idiopathic photodermatosis. Lesions usually occur in early spring within a few hours of exposure to sunlight. Usually, lesions persist for several days and resolve spontaneously. This chronic condition tends to improve as the sunny season progresses, a phenomenon known as Phototherapy and Photochemotherapy (PUVA) for Dermatological Conditions Jan 15 8 “hardening.” Diagnosis is based on the typical history and morphologic features of the lesion; the diagnosis can be confirmed by the induction of lesions with provocative phototesting. When lesions occur primarily on the face, a diagnosis of lupus must be excluded. Management consists of sun avoidance, the use of broadspectrum sunscreens, topical corticosteroids, and oral antihistamines. In severe cases, desensitization treatment using NB-UVB or PUVA has been successful. Desensitization is usually performed in early spring by exposing patients to increasing doses of NB-UVB or PUVA. Cutaneous T cell lymphoma (CTCL) (mycosis fungoides) Cutaneous B-cell non-Hodgkin's lymphoma (NHL) represents approximately 10% of all primary cutaneous lymphomas. Current initial therapies for CTCL are tailored to the extent, burden, and type of disease present. Treatment include use of emollients or topical corticosteroids, topical chemotherapy (nitrogen mustard, BCNU, bexarotene), phototherapy, psoralen–ultraviolet A (PUVA) therapy, electron beam irradiation, photon irradiation, extracorporeal photochemotherapy, chemotherapy, peripheral blood stem cell transplantation, and allogeneic transplantation. Mycosis fungoides is a variant of cutaneous T-cell lymphoma. The four types of cutaneous manifestations are patch, plaque, tumor, and erythrodermic. The patches are usually asymptomatic, although they occasionally may be mildly pruritic. As the disease progresses, some of the patches may become more indurated and may evolve into more elevated plaques. Nodular lesions may occur in patients without any patch or plaque lesions, although more commonly these lesions occur in conjunction with patches and plaques. Erythrodermic mycosis fungoides occurs as a generalized erythroderma with significant scaling and pruritus. Therapy for mycosis fungoides generally follows a sequential order: (1) topical nitrogen mustard or NBUVB, each of which can be combined with topical corticosteroids; (2) PUVA; (3) topical retinoids daily, until lesions resolve; and (4) one of the following: oral bexarotene or interferon-α subcutaneously 3 times weekly for 2 to 4 months. Large Plaque Parapsoriasis The two common variants of parapsoriasis are large plaque parapsoriasis and small plaque parapsoriasis. In up to one third of patients, large plaque parapsoriasis may evolve into mycosis fungoides. As a result, treatment of large plaque parapsoriasis is similar to that of early-stage mycosis fungoides: high-potency topical corticosteroids, topical nitrogen mustard, NB-UVB phototherapy, and PUVA. By comparison, patients with small plaque parapsoriasis have a benign course, and management of small plaque parapsoriasis should be symptomatic only, with emollients, topical corticosteroids, and NB-UVB phototherapy. Sclerotic Skin Disease (Connective Tissue Disease) Connective tissue diseases, also referred to as sclerosing skin diseases, are a group of clinical disorders that share an autoimmune etiology. Sclerosing skin diseases include systemic sclerosis (SSc), localized scleroderma (LS) also known as morphea, relapsing polychondritis, Sjogren syndrome, rheumatoid arthritis, adult-onset Still disease, mixed connective tissue disease, dermatomyositis, sclerodermoid Cutaneous Graft Versus Host Disease (GVHD), extragenital lichen sclerosus et atrophicus (extragenital LSA), lupus erythematosus (LE), and sclerodermoid rarities (e.g., eosinophilic fasciitis, pansclerotic morphea [a severe variant of LS]), and POEMS syndrome, which is characterized by polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes. In systemic sclerosis, fibrosis of the skin can lead to considerable morbidity. No significant improvement has been reported from studies investigating antifibrotic therapies. Phototherapy with ultraviolet (UV) irradiation is successfully used for Phototherapy and Photochemotherapy (PUVA) for Dermatological Conditions Jan 15 9 treatment of several diseases because of its anti-inflammatory as well as immunosuppressive mechanisms, and its low-risk profile. In addition, the UVA spectrum in particular exerts antifibrotic effects as it leads to reduction of procollagen synthesis and expression of collagenase-1 in vitro. Accordingly, treatment with long-wavelength UVA-1 irradiation or photochemotherapy with UVA plus the photosensitizer psoralen (PUVA) have been successfully used to reduce skin fibrosis in localized scleroderma. Phototherapy has been shown to stop or inhibit the fibrotic processes and to induce softening of sclerotic skin, especially in limited SSc. Phototherapy thus represents a therapeutic alternative for antifibrotic treatment with a low rate of adverse effects, which should be applied before the sclerotic process has proceeded too far. Review History November 2008 January 2010 February 2010 March 2011 January 2012 January 2013 January 2014 January 2015 Medical Advisory Council Committee initial approval Added treatment with phototherapy or topical or oral psoralen ultraviolet A (PUVA) as medically necessary for the treatment of vitiligo of the face and hands. Added link to the Vitiligo policy. Policy Updated. Treatment of vitiligo with ultraviolet B (UVB) radiation (phototherapy) or topical or oral psoralen ultraviolet A (photochemotherapy or PUVA) is no longer restricted to the face and hands. Update. Added Medicare Table. No revisions. Update – no revisions Update – no revisions. Added codes Update – no revisions. Added codes Update – no revisions. Codes updated This policy is based on the following evidence-based guidelines: 1. 2. 3. 4. 5. 6. 7. 8. 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 Sep;93(3 Suppl 2):S1-21. Hanifin JM, Cooper KD, Ho VC, et al. Guidelines of care for atopic dermatitis, developed in Page 13 of 16. Coverage Position Number: 0031. accordance with the American Academy of Dermatology (AAD)/American Academy of Dermatology Association "Administrative Regulations for Evidence-Based Clinical Practice Guidelines". J Am Acad Dermatol. 2004 Mar;50(3):391-404. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Vitiligo. May 2001. Revised Oct. 2006. Available at: http://www.niams.nih.gov/Health_Info/Vitiligo/default.asp#7 American Academy of Dermatology. Vitiligo. Hayes. Search and Summary. Phototherapy for Atopic Dermatitis. December 29, 2010. American Academy of Dermatology Work Group, Menter A, Korman NJ, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011 Jul;65(1):137-74. 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 Jan;62(1):114-35. Epub 2009 Oct 7. Hayes. Medical Technology Directory. Phototherapy for Acne Vulgaris. February 13, 2009. Update February 23, 2012. Updated January 25, 2013. Updated March 13, 2014. Phototherapy and Photochemotherapy (PUVA) for Dermatological Conditions Jan 15 10 9. Hayes. Medical Technology Directory. Ultraviolet B Phototherapy for Vitiligo. February 26, 2010. Update February 21, 2012. Updated February 1, 2013. Updated February 28, 2014. 10. Hayes. Health Technology Brief. Office-Based Phototherapy for Treatment of Atopic Dermatitis in Adults. August 16, 2011. Update August 22, 2012. Updated October 16, 2013. Archived September 16, 2014. 11. Hayes. Health Technology Brief. Office-Based Phototherapy for Treatment of Atopic Dermatitis in Children. August 22, 2011. Archived August 22, 2012. Updated October 16, 2013. Updated September 22, 2014. 12. Hayes. Health Technology Brief. Phototherapy for Early-Stage Mycosis Fungoides. January 30, 2012. Updated January 16, 2014. References – Update January 2015 1. 2. 3. Chen X, Yang M, Cheng Y, et al. Narrow-band ultraviolet B phototherapy versus broad-band ultraviolet B or psoralen-ultraviolet A photochemotherapy for psoriasis. Cochrane Database Syst Rev. 2013. Hoppe RT, Kim YK, Horowitz S. Treatment of early stage (IA to IIA) mycosis fungoides. UpToDate. June 20, 2014. Richard EG, Morrison W. Psoralen plus ultraviolet A (PUVA) photochemotherapy. UpToDate. January 16, 2014. References – Update January 2014 1. 2. 3. Archier E, Devaux S, Castela E, et al. Efficacy of psoralen UV-A therapy vs. narrowband UV-B therapy in chronic plaque psoriasis: A systematic literature review. J Eur Acad Dermatol Venereol. 2012;26 Suppl 3:11-21. Kim MB, Kim GW, Cho HH, et al. Narrowband UVB treatment of progressive macular hypomelanosis. J Am Acad Dermatol. 2012;66(4):598-605. Weberschock T, Strametz R, Lorenz M, et al. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2012;9 References – Update January 2013 1. 2. 3. 4. 5. Kerr AC, Ferguson J, Attili SK, et al. Ultraviolet A1 phototherapy: a British Photodermatology Group workshop report. Clin Exp Dermatol. 2012 Apr; 37 (3):219-26. Epub 2012 Jan 25. Kreutz M, Karrer S, Hoffmann P, et al. Whole-body UVB irradiation during allogeneic hematopoietic cell transplantation is safe and decreases acute graftversus-host disease. J Invest Dermatol. 2012;132(1):179-187. Reynolds NJ, Franklin V, Gray JC, et al. Narrow-band ultraviolet B and broadband ultraviolet A phototherapy in adult atopic eczema: A randomised controlled trial. Lancet. 2001;357(9273):2012-2016. Walker D, Jacobe H. Phototherapy in the age of biologics. Semin Cutan Med Surg. 2011 Dec;30(4):190-8. . Zandi S, Kalia S, Lui H. UVA1 phototherapy: a concise and practical review. Skin Therapy Lett. 2012 Jan;17(1):1-4. References – Update January 2012 1. 2. Babilas P, Szeimies RM. The use of photodynamic therapy in dermatology. G Ital Dermatol Venereol. 2010 Oct;145(5):613-30. Dogra S, De D. Phototherapy and photochemotherapy in childhood dermatoses. Indian J Dermatol Venereol Leprol. 2010 Sep-Oct;76(5):521-6 References – Update March 2011 1. 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 Phototherapy and Photochemotherapy (PUVA) for Dermatological Conditions Jan 15 11 2. treatment of psoriasis with phototherapy and photochemotherapy. J Am Acad Dermatol. 2010;62(1):114-135. Tzaneva S, Kittler H, Holzer G, et al. 5-Methoxypsoralen plus ultraviolet (UV) A is superior to medium-dose UVA1 in the treatment of severe atopic dermatitis: A randomized crossover trial. British Journal of Dermatology. 162 (3) (pp 655660), 2010. References – Update January 2010 1. Abdulla SJ, Desgroseilliers JP. Treatment of vitiligo with narrow-band ultraviolet B: advantages and disadvantages. J Cutan Med Surg. 2008 Jul-Aug;12(4):1749. 2. Akar A, Tunca M, Koc E, Kurumlu Z. Broadband targeted UVB phototherapy for localized vitiligo: a retrospective study. Photodermatol Photoimmunol Photomed. 2009 Jun;25(3):161-3. 3. Asawanonda P, Kijluakiat J, Korkij W, Sindhupak W. Targeted broadband ultraviolet b phototherapy produces similar responses to targeted narrowband ultraviolet B phototherapy for vitiligo: a randomized, double-blind study. Acta Derm Venereol. 2008;88(4):376-81. 4. Bhatnagar A, Kanwar AJ, Parsad D, De D. Comparison of systemic PUVA and NBUVB in the treatment of vitiligo: an open prospective study. J Eur Acad Dermatol Venereol. 2007 May;21(5):638-42. 5. Bhatnagar A, Kanwar AJ, Parsad D, De D. Psoralen and ultraviolet A and narrowband ultraviolet B in inducing stability in vitiligo, assessed by vitiligo disease activity score: an open prospective comparative study. J Eur Acad Dermatol Venereol. 2007 Nov;21(10):1381-5. 6. Brazzelli V, Antoninetti M, Palazzini S, et al. Critical evaluation of the variants influencing the clinical response of vitiligo: study of 60 cases treated with ultraviolet B narrow-band phototherapy. J Eur Acad Dermatol Venereol. 2007 Nov;21(10):1369-74. 7. Forschner T, Buchholtz S, Stockfleth E. Current state of vitiligo therapy-evidence-based analysis of the literature. J Dtsch Dermatol Ges. 2007 Jun;5(6):467-75 8. Percivalle S, Piccino R, Caccialanza M, Forti S. Narrowband UVB phototherapy in vitiligo: evaluation of results in 53 patients. G Ital Dermatol Venereol. 2008 Feb;143(1):9-14 9. Welsh O, Herz-Ruelas ME, Gómez M, Ocampo-Candiani J. Therapeutic evaluation of UVB-targeted phototherapy in vitiligo that affects less than 10% of the body surface area. Int J Dermatol. 2009 May;48(5):529-34. 10. Whitton ME, Ashcroft DM, González U. Therapeutic interventions for vitiligo. J Am Acad Dermatol. 2008 Oct;59(4):713-7 11. Yones SS, Palmer RA, Garibaldinos TM, Hawk JL. Randomized double-blind trial of treatment of vitiligo: efficacy of psoralen-UV-A therapy vs Narrowband-UV-B therapy. Arch Dermatol. 2007 May;143(5):578-84. References 1. 2. 3. 4. Ong PY, Bogienewitz M. Atopic Dermatitis. Primary Care: Clinics in Office Practice. Volume 35, Issue 1 (March 2008). Sunderkötter C, Kuhn A, Hunzelmann N, et al. Phototherapy: a promising treatment option for skin sclerosis in scleroderma? Rheumatology (Oxford). 2008 Feb; 47(2): 234-5. Habermann TM, Pittelkow MR. Chapter 113, Cutaneous T-Cell Lymphoma and Cutaneous B-Cell Lymphoma. Abeloff: Abeloff's Clinical Oncology, 4th ed. 2008. Aydogan K, Saricaoglu H, Turan H. Narrowband UVB (311 nm, TL01) phototherapy for pityriasis lichenoides. Photodermatol Photoimmunol Photomed. 2008 Jun;24(3):128-33. Phototherapy and Photochemotherapy (PUVA) for Dermatological Conditions Jan 15 12 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. Kroft EB, van de Kerkhof PC, Gerritsen MJ, et al. Period of remission after treatment with UVA-1 in sclerodermic skin diseases. J Eur Acad Dermatol Venereol. 2008 Jul;22(7):839-44. Epub 2008 Apr 30. Rombold S, Lobisch K, Katzer, et al. Efficacy of UVA1 phototherapy in 230 patients with various skin diseases. Photodermatol Photoimmunol Photomed. 2008 Feb;24(1):19-23. Wang F, Garza LA, Cho S, et al. Effect of Increased Pigmentation on the Antifibrotic Response of Human Skin to UV-A1 Phototherapy. Arch Dermatol. 2008; 144 (7): 851-858. Weston WL, Howe W. Dermatitis. UpToDate. 2007. Wackernagel A, Legat FJ, Hofer A, et al. Psoralen plus UVA vs. UVB-311 nm for the treatment of lichen planus. Photodermatol Photoimmunol Photomed. 2007 Feb;23 (1):15-9. Australian Council on Healthcare Standards (ACHS). Australian clinical indicator report 1998-2006. Determining the potential to improve quality of care: 8th edition. ULTIMO NSW: Australian Council on Healthcare Standards (ACHS); 2007. 564 p. American Academy of Dermatology (AAD). Public resource center. Psoriasis and psoriatic arthritis. 2007. Clayton TH, Clark SM, Turner D, Goulden V. The treatment of severe atopic dermatitis in childhood with narrowband ultraviolet B phototherapy. Clin Exp Dermatol. 2007 Jan;32 1):28-33. Kirke SM, Lowder S, Lloyd JJ, Diffey BL, Matthews JN, Farr PM. A randomized comparison of selective broadband UVB and narrowband UVB in the treatment of psoriasis. J Invest Dermatol.2007 Jul;127(7):1641-6. Epub 2007 Mar 22. Legat FJ, Hofer A, Wackernagel et al. Narrowband UV-B phototherapy, alefacept, and clearance of psoriasis. Arch Dermatol. 2007 Aug;143(8):1016-22. Meduri NB, Vandergriff T, Rasmussen H, Jacobe H. Phototherapy in the management of atopic dermatitis: a systematic review. Photodermatol Photoimmunol Photomed. 2007 Aug;23(4):106-12. Brown S, Reynolds NJ. Atopic and non-atopic eczema. BMJ. 2006 Mar 11;332(7541):584-8. El-Mofty M, Mostafa W, Youssef R, et al. Nonlaser UVB-targeted phototherapy treatment of psoriasis. Cutis. 2006 Sep;78(3):200-3. Koek MB, Buskens E, Bruijnzeel-Koomen CA, Sigurdsson V. Home ultraviolet B phototherapy for psoriasis: Discrepancy between literature, guidelines, general opinions and actual use. Results of a literature review, a web search, and a questionnaire among dermatologists. Br J Dermatol. 2006;154(4):701-711. Claes C, Kulp W, Greiner W, et al. Therapy of moderate and severe psoriasis. HTA Report. Cologne, Germany: German Agency for Health Technology Assessment at the German Institute for Medical Documentation and Information (DAHTA) (DIMDI); 2006. Akdis CA, Akdis M, Bieber T. The European Academy of Allergology and Clinical Immunology/American Academy of Allergy, Asthma and Immunology/PRACTALL Consensus Group, et al: 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. J Allergy Clin Immunol 118. 152-169. 2006. Stadler R, Kreamer A, Luger T, et al. Prospective, randomized, multicenter clinical trial on the use of IFN 2 alpha plus PUVA versus PUVA in cutaneous T-cell lymphoma. Proc Am Soc Clin Oncol 2006; 26:432s. Trautinger F, Knobler R, Willemze R, et al. EORTC consensus recommendations for the treatment of mycosis fungoides/Sézary syndrome. Eur J Cancer 2006; 42:1014-1030. Lebwohl M, Ting PT, Koo JY. Psoriasis treatment: traditional therapy. Ann Rheum Dis. 2005 Mar;64 Suppl 2:ii83-6. Phototherapy and Photochemotherapy (PUVA) for Dermatological Conditions Jan 15 13 24. Szegedi A, Simics E, Aleksza M, et al. Ultraviolet-A1 phototherapy modulates Th1/Th2 and Tc1/Tc2 balance in patients with systemic lupus erythematosus. Rheumatology. ISSN 1462-0324, 2005, vol. 44, no7, pp. 925-931. 25. Giardi M, Heald PW, Wilson LD: The pathogenesis of mycosis fungoides. N Engl J Med 2004; 350:1978-1988. 26. Ibbotson SH, Bilsland D, Cox NH, et al. British Association of Dermatologists. An update and guidance on narrowband ultraviolet B phototherapy: a British Photodermatology Group Workshop Report. Br J Dermatol. 2004 Aug;151(2):283-97. 27. Bandow GD, Koo JY. Narrow-band ultraviolet B radiation: A review of the current literature. Int J Dermatol. 2004;43(8):555-561. 28. Naldi L, Rzany B. Chronic plaque psoriasis. In: Clinical Evidence. London, UK: BMJ Publishing Group; updated June 2004. 29. Polderman MC, le Cessie S, Huizinga TW, et al. Efficacy of UVA-1 cold light as an adjuvant therapy for systemic lupus erythematosus. Rheumatology (Oxford). 2004 Nov;43 (11):1402-4. Epub 2004 Aug 10. 30. Snellman E. Psoriasis. In: EBM Guidelines. Evidence-Based Medicine. Helsinki, Finland: Duodecim Medical Publications Ltd.; June 18, 2004. 31. Cooper SM, Burge SM. Darier's disease: Epidemiology, pathophysiology, and management. Am J Clin Dermatol. 2003;4(2):97-105. 32. Sullivan TJ. Managed care’s perspective on treatment of psoriasis. Managed Care. 2003;12(5 Suppl):14-17. 33. Boguniewicz M.: Atopic dermatitis. Immunol Allergy Clinics N Am 22. 1178.2002. 34. Gathers RC, Scherschun L, Malick F, et al. Narrow-band UBV phototherapy for early-stage mycosis fungoides. American Academy of Dermatology. 2002; 47:191-197. 35. Reynolds NJ, Franklin V, Gray JC, et al. Narrow-band ultraviolet B and broadband ultraviolet A phototherapy in adult atopic eczema: A randomised controlled trial. Lancet. 2001;357(9273):2012-2016. 36. Griffiths CE, Clark CM, Chalmers RJ, et al. A systematic review of treatments for severe psoriasis. Health Technol Assess. 2000;4(40:1-125. 37. Hoare C, Li Wan Po A, Williams H. Systematic review of treatments for atopic eczema. Health Technol Assess. 2000;4(37):1-191. 38. Simon JC, Pfieger D, Schopf E. Recent advances in phototherapy. Eur J Dermatol. 2000;10(8):642-645. Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net’s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member’s benefits, nor is it intended to dictate to providers how to practice medicine. Phototherapy and Photochemotherapy (PUVA) for Dermatological Conditions Jan 15 14 Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. states, prior notice or website posting is required before an amendment is deemed effective. In some No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member’s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member’s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member’s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member’s contract shall govern. The Policies do not replace or amend the Member’s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code 1367.63 requires health care service plans to cover reconstructive surgery. “Reconstructive surgery” means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean “cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code 1367.6 requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid Phototherapy and Photochemotherapy (PUVA) for Dermatological Conditions Jan 15 15 members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Phototherapy and Photochemotherapy (PUVA) for Dermatological Conditions Jan 15 16
© Copyright 2024