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DESCRIPTIONLight therapy for psoriasis includes phototherapy with ultraviolet B (UVB) light boxes, targeted phototherapy, and photochemotherapy with psoralen plus ultraviolet A (PUVA). Targeted phototherapy describes the use of ultraviolet light focused on specific body areas or lesions. PUVA uses a psoralen derivative in conjunction with long wavelength ultraviolet A (UVA) light (sunlight or artificial) for photochemotherapy of skin conditions.
Psoriasis is a common chronic immune-mediated disease characterized by skin lesions ranging from minor localized patches to complete body coverage. There are several types of psoriasis; most common is plaque psoriasis which is associated with red and white scaly patches on the skin. In addition to being a skin disorder, psoriasis can negatively impact many organ systems and is associated with an increased risk of cardiovascular disease, some types of cancer, and autoimmune diseases (eg, celiac disease and Crohn disease). Although disease severity is minimally defined by body surface area (mild psoriasis affects less than 5% of the body’s surface area, moderate psoriasis affects 5% to 10%, and severe disease affects more than 10% body surface area), lesion characteristics (eg, location and severity of erythema, scaling, induration, pruritus) and impact on quality of life are also taken into account.
Topical therapy (eg, corticosteroids, vitamin D analogues) is generally considered first-line treatments of psoriasis, especially for mild disease. Phototherapy and systemic therapy are treatment options for patients with more extensive and/or severe disease and those who fail conservative treatment with topical agents. Phototherapy is available in various forms including exposure to natural sunlight, use of broadband ultraviolet B (BB-UVB) devices, narrowband ultraviolet B (NB-UVB) devices, targeted therapy, and psoralen plus ultraviolet A (PUVA). NB-UVB is an established treatment for psoriasis, based on efficacy and safety. This policy addresses two alternative treatments: targeted phototherapy, which uses ultraviolet light that can be focused on specific body areas or lesions, and PUVA. A related treatment, photodynamic therapy, is addressed in the Dermatologic Applications of Photodynamic Therapy medical policy.
Potential advantages of targeted phototherapy include the ability to use higher treatment doses and to limit exposure to surrounding tissue. Broadband ultraviolet B (BB-UVB) devices, which emit wavelengths from 290 to 320 nm, have been largely replaced by NB-UVB devices. NB-UVB devices eliminate wavelengths below 296 nm, which are considered erythemogenic and carcinogenic but not therapeutic. NB-UVB is more effective than BB-UVB and approaches PUVA in efficacy. Original NB-UVB devices consisted of a Phillips TL-01 fluorescent bulb with a maximum wavelength (lambda max) at 311 nm. Subsequently, xenon chloride (XeCl) lasers and lamps were developed as targeted NB-UVB treatment devices. They generate monochromatic or very narrow band radiation with a lambda max of 308 nm. Targeted phototherapy devices are directed at specific lesions or affected areas, thus limiting exposure to the surrounding normal tissues. They may therefore allow higher dosages compared to a light box, which could result in fewer treatments to produce clearing. The original indication of the excimer laser was for patients with mild-to-moderate psoriasis, defined as involvement of less than 10% of the skin. Newer XeCl laser devices are faster and more powerful than the original models, which may allow treatment of patients with more extensive skin involvement (10%–20% of body surface area).
Psoralen Plus Ultraviolet A
Psoralens with ultraviolet A (UVA) uses a psoralen derivative in conjunction with long wavelength UVA light (sunlight or artificial) for photochemotherapy of skin conditions. Psoralens are tricyclic furocoumarins that occur in certain plants and can also be synthesized. They are available in oral and topical forms. Oral PUVA is generally given 1.5 hours before exposure to UVA radiation. Topical PUVA therapy refers to directly applying the psoralen to the skin with subsequent exposure to UVA light. Bath PUVA is used in some European countries for generalized psoriasis, but the agent used (trimethylpsoralen) is not approved by the Food and Drug Administration. Paint PUVA and soak PUVA are other forms of topical application of psoralen and are often used for psoriasis localized to the palms and soles. In paint PUVA, 8-methoxypsoralen in an ointment or lotion form is put directly on the lesions. With soak PUVA, the affected areas of the body are placed in a basin of water containing psoralen. With topical PUVA, UVA exposure is generally administered within 30 minutes of psoralen application.
PUVA has most commonly been used to treat severe psoriasis, for which there is no generally accepted first-line treatment. Each treatment option (e.g., systemic therapies such as methotrexate, phototherapy, biologic therapies) has associated benefits and risks. Common minor toxicities associated with PUVA include erythema, pruritis, irregular pigmentation, and gastrointestinal tract symptoms; these generally can be managed by altering the dose of psoralen or UV light. Potential long-term effects include photoaging and skin cancer, particularly squamous cell carcinoma and possibly malignant melanoma. PUVA is generally considered more effective than targeted phototherapy for the treatment of psoriasis. However, the requirement of systemic exposure and the higher risk of adverse reactions (including a higher carcinogenic risk) have generally limited PUVA therapy to patients with more severe disease.
In 2001, XTRAC™ (PhotoMedex), a xenon chloride (XeCl) excimer laser, was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for the treatment of mild-to-moderate psoriasis. The 510(k) clearance was subsequently obtained for a number of targeted UVB lamps and lasers, including newer versions of the XTRAC system (eg, XTRAC Ultra™), the VTRAC™ lamp (PhotoMedex), the BClear™ lamp (Lumenis), and the European manufactured Excilite™ and Excilite µ™ XeCL lamps.
In 2010, the Levia Personal Targeted Phototherapy® UVB device (Daavlin, Bryan, OH; previously manufactured by Lerner Medical Devices, Los Angeles, CA) was cleared for marketing by FDA through the 510(k) process for home treatment of psoriasis.
The oral psoralen products Oxsoralen-Ultra (methoxsalen soft gelatin capsules) and 8-MOP (methoxsalen hard gelatin capsules) have been approved by FDA; both are made by Valeant Pharmaceuticals. Topical psoralen products have also received FDA approval (eg, Oxsoralen; Valeant Pharmaceuticals).
POLICYPUVA for the treatment of severe, disabling psoriasis, which is not responsive to other forms of conservative therapy (e.g., topical corticosteroids, coal/tar preparations, and ultraviolet light), may be considered medically necessary.
Targeted phototherapy may be considered medically necessary for the treatment of moderate-to-severe localized psoriasis comprising less than 20% body area for which NB-UVB or PUVA are indicated.
Targeted phototherapy may be considered medically necessary for the treatment of mild-to-moderate psoriasis that is unresponsive to conservative treatment.
Targeted phototherapy is considered investigational for the first-line treatment of mild psoriasis.
Targeted phototherapy is considered investigational for the treatment of generalized psoriasis or psoriatic arthritis.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Disease severity is minimally defined by body surface area (mild psoriasis affects less than 5% of the body’s surface area, moderate psoriasis affects 5% to 10%, and severe disease affects more than 10% body surface area). However, lesion characteristics (e.g., location and severity of erythema, scaling, induration, and pruritus) and impact on quality of life are also taken into account. For example, while one handprint is equal to approximately 1% body surface area, lesions on the hands, feet, or genitalia that cause disability may be classified as moderate-to-severe. The Psoriasis Area and Severity Index (PASI) may be used as an outcome measure in clinical research. Clinical assessment of disease severity is qualitative.
Established treatments for psoriasis include use of topical ointments and ultraviolet light (“light lamp”) treatments. Lasers and targeted ultraviolet B (UVB) lamps are considered equivalent devices; targeted UV devices are comparable with UV light panels for treatment purposes. First-line treatment of UV-sensitive lesions may involve around 6 to 10 office visits; treatment of recalcitrant lesions may involve around 24 to 30 office visits. Maintenance therapy or repeat courses of treatment may be required.
During PUVA therapy, the patient needs to be assessed on a regular basis to determine the effectiveness of the therapy and the development of adverse effects. These evaluations are essential to ensure that the exposure dose of radiation is kept to the minimum compatible with adequate control of disease. Therefore, PUVA is generally not recommended for home therapy.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY5/2002: Approved by Medical Policy Advisory Committee (MPAC), Code Reference section completed, CPT code 96910, 96999 added, ICD-9 diagnosis code 969.1 added
11/2002: Reviewed by MPAC; maintained investigational status
3/7/2003: Code Reference section updated, CPT code 96910 deleted, CPT code 96920, 96921, 96922 added
8/1/2003: ICD-9 diagnosis code 969.1 deleted, ICD-9 diagnosis code 696.1 added
8/26/2005: Code Reference section updated, CPT code 96920, 96921, 96922 deleted, ICD-9 diagnosis code 696.1 deleted
1/10/2007: Policy reviewed, no changes
3/15/2007: Code Reference section reviewed. CPT codes 96920, 96921, and 96922 added to non-covered table.
3/20/2007: Policy updated and medically necessary indications added for the treatment of mild to severe psoriasis. CPT codes 96920-96922 moved to covered. ICD-9 696.1 added. CPT code 96999 removed.
12/13/2007: Policy reviewed, no changes.
04/23/2010: Policy title changed from “Xenon Chloride Excimer Laser Therapy for Phototherapeutic Treatment of Psoriasis” to “Targeted Phototherapy for Psoriasis.” Policy description and guidelines updated regarding new treatment approaches. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Deleted outdated references in the Sources section.
04/18/2011: Policy reviewed; no changes.
04/12/2012: Policy reviewed; no changes.
05/08/2012: Updated the policy description regarding light therapy. Added the following policy statement: PUVA for the treatment of severe, disabling psoriasis, which is not responsive to other forms of conservative therapy (e.g., topical corticosteroids, coal/tar preparations, and ultraviolet light), may be considered medically necessary.
04/17/2013: Policy reviewed; no changes to policy statement. Title changed from "Targeted Photherapy for Psoriasis" to "Light Therapy for Psoriasis."
03/12/2014: Policy reviewed; description updated regarding FDA-approved psoralen products. Policy statement unchanged.
03/06/2015: Policy reviewed; description updated regarding psoriasis and treatment options. Policy statements unchanged.
08/26/2015: Medical policy revised to add ICD-10 codes.
02/11/2016: Policy description updated regarding disease severity. Policy statements unchanged. Policy guidelines updated regarding treatments for psoriasis. Added medically necessary and investigational definitions.
06/01/2016: Policy number A.2.01.47 added.
01/13/2017: Policy description updated. Policy statements unchanged.
SOURCE(S)Blue Cross Blue Shield Association Policy # 2.01.47
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.