National Medical Policy Subject: Benign Skin Lesion Removal Policy Number: NMP150 Effective Date: June 2004 Updated: May 2006, September 2009, November 2009, January 2011, September 2011 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source X National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD) X Article (Local) Other None Reference/Website Link Search Term Lesion Removal Removal of Benign or Premalignant Skin Lesions Removal of Benign Skin Lesions Skin Lesion (Non-Melanoma) Removal Skin LESION REMOVAL (Includes AK and Excludes MOHS) Treatment of Ulcers & Symptomatic Hyperkeratoses http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx Non-malignant Skin LESION REMOVAL Policy – Addendum 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 Benign Skin Lesion Removal Sep 11 1 search instructions. Enter the topic and your specific state to find the coverage determinations for your region 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. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Medical Policy (Update September 2011 – A Medline search failed to reveal any studies that would cause Health Net, Inc. to change its current positon) Benign skin lesions include seborrheic keratoses, sebaceous (epidermoid) cysts, skin tags, milia (keratin-filled cysts), nevi (moles), acquired hyperkeratosis (keratoderma), papillomas, hemangiomas and viral warts. Health Net, Inc. considers removal of benign skin lesions as medically necessary, and not cosmetic, when any of the following is met and is clearly documented in the medical record, operative report or pathology report: 1. The lesion is symptomatic as documented by any of the following: Intense itching Burning Irritation Pain Tenderness Chronic, recurrent or persistent bleeding Physical evidence of inflammation (e.g., purulence, oozing, edema, erythema, etc.) 2. The lesion demonstrates a significant change in color or size 3. The lesion obstructs an orifice or clinically restricts vision. 4. There is clinical uncertainty as to the likely diagnosis, particularly where malignancy is a realistic consideration based on lesional appearance, change in appearance and/or non-response to conventional treatment* The lesion is likely to turn malignant as documented by medical peerreviewed literature or medical textbooks 5. 6. A prior biopsy suggests the possibility of lesional malignancy. 7. The lesion is in an anatomical region subjected to recurrent physical trauma that has in fact occurred and objective evidence of such injury or the potential for such injury is documented. 8. Wart removals is considered medically necessary when any of 1 through 8 above is met; in addition, wart destructions are considered medically necessary when any of the following is met: Lesion causes symptoms of such a severity that the patient’s normal bodily functions/activities of daily living are impeded (e.g., palmar or plantar warts) Benign Skin Lesion Removal Sep 11 2 Periocular warts associated with chronic recurrent conjunctivitis thought secondary to lesion virus shedding; Warts showing evidence of spread from one body area to another, particularly in immunosuppressed patients. Lesions are condyloma acuminata or molluscum contagiosum. Cervical dysplasia or pregnancy associated with genital warts Warts showing evidence of spreading from one body area to another, particularly in the immunosuppressed patients. *Note: If the diagnosis is uncertain, biopsy or removal may be more prudent than destruction. Note: The decision to submit a specimen for pathological interpretation will be independent of the decision to remove or not remove the lesion. It is assumed, however, that the pathology description and tissue diagnosis will be part of the medical record if a specimen is submitted to pathology. Note: Should lesions be a concern but not be explicitly described in this policy, color photographs must be submitted with the request. Health Net, Inc. does not consider lesion removal medically necessary for any of the following: 1. Lesions in sensitive anatomic locations that are non-problematic do not qualify for removal coverage on the basis of location alone. 2. Rosacea 3. Vascular proliferative disorders Actinic Keratoses – Update November 2009 Health Net Inc, consider the destruction of correctly diagnosed actinic keratoses, also known as solar keratoses, medically necessary as they are considered to be premalignant lesions with a low but real possibility of malignant transformation. I. Health Net Inc, considers any of the following treatment for actinic keratoses medically necessary: 1. Liquid nitrogen cryotherapy Most common treatment, usually recommended for treatment of solitary lesions or small numbers of scattered lesions and/or thin, well-demarcated lesions 2. Topical drug therapy (e.g. 5-fluorouracil) 3. May cause skin redness; blistering may occur Recommended for individuals with more than 15 actinic keratoses Anatomic location of the lesions impacts response time. AK’s of the face respond the quickest, whereas lesions on the arms usually take the longest to respond. Any of the following treatment for multiple actinic keratoses is considered medically necessary when there is failure to adequately respond to topical 5FU or cryosurgery: Benign Skin Lesion Removal Sep 11 3 II. Laser skin resurfacing therapy Chemical peel Dermabrasion Health Net, Inc. considers photodynamic therapy (PDT) with topical aminolevulinic acid (Levulan Kerastick) and exposure to blue light medically necessary for non-hyperkeratotic actinic keratoses of the face and scalp. Note: Lesions treated with Levulan Kerastick that have not completely resolved after 8 weeks may be treated a second time. However, in the absence of data that indicate efficacy for a third treatment, the medical necessity for a third treatment of the same lesion(s) is not established. III. Health Net, Inc. considers photodynamic therapy PDT with topical Metvixia, followed by exposure to a red light source medically necessary in immunocompetent patients in conjunction with lesion preparation (debridement using a sharp dermal curette) when other therapies are unacceptable or considered medically less appropriate. Note: Metvixia Cream has not been studied for more than one course which consists of two treatment sessions one week apart. Lesion response should be assessed 3 months after the last treatment session. IV. Electrodessication and curettage or full-thickness excision of actinic keratoses is rarely medically necessary. However, excisional biopsy of actinic keratoses may be considered medically necessary when the following criteria are met: V. 1. There is bleeding, induration, rapid growth or pain, which suggest progression to squamous cell carcinoma 2. The lesion does not respond to treatment An alternative approach to treating AKs is to observe the lesions over time and remove them only if they exhibit specific clinical features suggesting possible transformation to invasive squamous cell carcinoma (SCC). Note: Health Net, Inc. does not consider removal of skin lesions to improve appearance medically necessary. Removal of certain benign skin lesions that do not pose a threat to health or function are considered cosmetic, and as such, are not medically necessary. In the absence of any of the above indications, removal of seborrheic keratoses, sebaceous cysts, nevi (moles) or skin tags is considered cosmetic. Note: Excision of lesion with simple closure should be coded as excision only. A simple repair is used when the wound is superficial; e.g., involving primarily epidermis or dermis, or subcutaneous tissues without significant involvement of deeper structures, and requires simple one layer closure/suturing. Excision of lesions with intermediate or complex closure should be coded separately for benign lesions with a diameter greater than 0.5cm or the excision of a malignant lesion of any size. An intermediate repair includes the repair of wounds that require layered closure of one or more of the deeper layers of subcutaneous tissue and superficial (nonmuscle) fasciae, in addition to the skin (epidermal and dermal) closure. Complex Benign Skin Lesion Removal Sep 11 4 repair includes the repair of wounds requiring more than layered closure including scar revision, debridement, (e.g., traumatic lacerations or avulsions, extensive undermining, stents or retention sutures). Excision of lesion with adjacent tissue transfer should be coded as adjacent tissue transfer only. Codes Related To This Policy ICD-9 078.0 078.10 078.11 078.19 135 210.0 214.0– 214.1 215.0 215.3 216.0 216.1 216.2 216.3 216.4 216.5 216.6 216.7 216.8 221.2 222.1 222.4 228.01 235.1 238.2 239.2 374.84 380.00380.02 455.9 448.1 528.5 682.0682.9 686.1 686.8 690.10 690.11 690.12 690.18 690.8 691.8 692.70 Molluscum contagiosum Viral warts, unspecified Condyloma acuminatum Other specified viral warts Sarcoidosis (cutaneous) Benign neoplasm of lip (specify type) Lipoma of skin and subcutaneous tissue Other benign neoplasm of connective and other soft tissue of head, face and neck Other benign neoplasm of connective and other soft tissue of lower limb, including hip Benign neoplasm of skin of lip Benign neoplasm of eyelid, including canthus Benign neoplasm of skin of ear and external auditory canal Benign neoplasm of skin of other and unspecified parts of face Benign neoplasm of skin of scalp and neck Benign neoplasm of skin of trunk except scrotum Benign neoplasm of skin of upper limb, including shoulder Benign neoplasm of skin of lower limb, including hip Benign neoplasm of skin of other specified sites Benign neoplasm of vulva Benign neoplasm of penis Benign neoplasm of scrotum Hemangioma of skin and subcutaneous tissue Neoplasm of uncertain behavior of lip Neoplasm of uncertain behavior of skin Neoplasm of unspecified nature, skin Sebaceous cyst of eyelid Perichondritis of pinna (chondrodermatitis) Residual hemorrhoidal skin tags Nevus, nonneoplastic Diseases of lip Cellulitis and abscess Pyogenic granuloma of skin and subcutaneous tissue Other specified local infections of skin and subcutaneous tissue Seborrheic dermatitis, unspecified Seborrhea capitis Seborrheic infantile dermatitis Other seborrheic dermatitis Other erythematosquamous dermatosis Other atopic dermatitis and related conditions Unspecified dermatitis due to sun Benign Skin Lesion Removal Sep 11 5 692.75 695.89 695.9 698.9 698.3 701.0 701.2 701.1 701.4 701.9 702.0 702.11 702.19 706.2 709.9 744.1 759.39 782.0 959.8 Disseminated superficial actinic porokeratosis (DSAP) Other specified erythematous conditions Unspecified erythematous conditions Unspecified pruritus disorder Prurigo nodularis Circumscribed scleroderma Acquired acanthosis nigricans Keratoderma (acquired) symptomatic, painful and/or inflamed Keloid Skin tags Actinic keratosis Inflamed seborrheic keratosis Other seborrheic keratosis Sebaceous cyst Unspecified disorder of skin and subcutaneous tissue Accessory auricle Other anomalies of the skin Pain, paresthesia, burning of skin Injury [trauma] of other specified site, skin CPT Codes 11200 11201 11300 11301 11302 11303 11305 11306 11307 11308 11310 11311 11312 11313 11400 11401 11402 11403 11404 11406 11420 11421 11422 11423 Removal of skin tags, multiple fibrocutaneous tags, any area; up to and including 15 lesions each additional ten lesions (List separately in addition to code for primary procedure) Shaving of epidermal or dermal lesions, single lesion, trunk, arms or legs; lesion diameter 0.5 cm or less lesion diameter 0.6 to1.0 cm lesion diameter 1.1 to 2.0 cm lesion diameter over 2.0 cm Shaving of epidermal or dermal lesion, single lesion, scalp, neck, hands, genitalia; lesion diameter 0.5 cm lesion diameter 0.6 to 1.0 cm lesion diameter 1.1 to 2.0 cm lesion diameter over 2.0 cm Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter 0.5 cm or less lesion diameter 0.6 to 1.0 cm lesion diameter 1.1 to 2.0 cm lesion diameter over 2.0 cm Excision, benign lesion including margins, except skin tag (unless listed elsewhere), trunk, arms or legs; excised diameter 0.5 or less excised diameter 0.6 to 1.0 cm excised diameter 1.1 to 2.0 cm excised diameter 2.1 to 3.0 cm excised diameter 3.1 to 4.0 cm excised diameter over 4.0 cm Excision, benign lesion including margins, except skin tag (unless listed elsewhere), scalp, neck, hands, feet, genitalia; excised diameter 0.5 cm or less excised diameter 0.6 to 1.0 cm excised diameter 1.1 to 2.0 cm excised diameter 2.1 to 3.0 cm Benign Skin Lesion Removal Sep 11 6 11424 11426 11440 11441 11442 11443 11444 11446 1200112007 1201112018 1203112037 1204112047 1205112057 13100 12102 13120 13121 13131 13132 13133 13150 13151 13152 13153 13160 14000 14001 14020 14021 14040 14041 14060 10461 excised diameter 3.1 to 4.0 cm lesion diameter over 4.0 cm Excision, other benign lesion including margins(unless listed elsewhere), face, ears, eyelids, nose, lips, mucous membrane; excised diameter 0.5 cm or less excised diameter 0.6 to 1.0 cm excised diameter 1.1 to 2.0 cm excised diameter 2.1 to 3.0 cm excised diameter 3.1 to 4.0 cm excised diameter over 4.0 cm Simple repair of superficial wounds of scalp, neck, axillae, external genitalia, trunk and or extremities (including hands and feet); 2.5cm or less - over 30cm Superficial repair of superficial wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 2.5cm or less - over 30cm Repair, intermediate, wounds of scalp, axillae, trunk and/or extremities (excluding hands and feet); 2.5 cm or less to 30.0 cm Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; 2.5 cm or less -over 30 cm Repair, intermediate, wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 2.5 cm or less- over 30 cm. Repair, complex, trunk; 1.1 cm to 2.5 cm each additional 5 cm or less (List separately in addition to code for primary procedure) (Code deleted) Repair, complex, scalp, arms and/or legs:1.1.cm to 2.5 cm each additional 5 cm or less (List separately in addition to code for primary procedure) Repair, complex, forehead, cheek, chin, mouth, neck, axillae, genitalia, hands and/or feet; 1.1 cm to 2.5 cm 2.6 cm to 7.5 cm each additional 5 cm or less (List separately in addition to code for primary procedure) Repair, complex, eyelids, nose, ears and/or lips; 1.0 cm or less 1.1 cm to 2.5 cm 2.6 cm to 7.5 cm each additional 5 cm or less (List separately in addition to code for primary procedure) Secondary closure of surgical wound or dehiscence, extensive or complicated Adjacent tissue transfer or rearrangement, trunk; defect 10 sq cm or less defect 10.1 sq cm to 30 sq cm Adjacent tissue transfer or rearrangement, scalp, arms and/or legs; defect 10 sq cm or less defect 10.1 sq cm to 30 sq cm Adjacent tissue transfer or rearrangement, forehead, cheeks, chin, mouth, neck, axillae, genitalia, hands and/or feet; defect 10 sq cm or less defect 10.1 sq cm to 30 sq cm Adjacent tissue transfer or rearrangement, eyelids nose, ears and/or lips; defect 10sq cm or less defect 10.1 sq cm to 30 sq cm Benign Skin Lesion Removal Sep 11 7 14300 14301 14302 17000 17003 17004 17110 17111 96567 Adjacent tissue transfer or rearrangement, more than 30sq cm, usual or complicated, any area (Code deleted in 2011. To report, see 14301, 14302) Adjacent tissue transfer or rearrangement, any area; defect 30.1 sq cm to 60.0 sq cm Adjacent tissue transfer or rearrangement, each additional 30.0 sq cm. Or part thereof (List separately in addition to code for primary procedure) Destruction (e.g., laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), premalignant lesions (e.g., actinic keratoses); first lesion second through 14 lesions, each (List separately in addition to code for first lesion) Destruction (e.g., laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement) premalignant lesions (e.g., actinic keratoses); 15 or more lesions Destruction (e.g., laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), of benign lesions other than skin tags or cutaneous vascular proliferative lesions; up to 14 lesions 15 or more lesions Photodynamic therapy by external application of light to destroy premalignant and/or malignant lesions of the skin and adjacent mucosa (e.g.lip) by activation of photosensitive drug(s), each phototherapy exposure session HCPCS Codes J3490 J7308 J9190 Unclassified drugs Aminolevulinic acid HCL for topical administration, 20%, single unit dosage form (354 mg) Injection, fluorouracil, 500 mg (Use this code for Adrucil) Scientific Rationale - Update September 2009 According to the American Academy of Dermatology, available treatment of actinic keratoses (AK) may include cryosurgery, topical chemotherapy (e.g., 5-fluoruracil), topical immunotherapy (e.g., imiquimod), topical non-steroidal anti-inflammatory drugs (e.g. sodium diclofenac gel), photodynamic therapy with exposure to red or blue light, chemical peels and laser therapy. Dermatologists may use one therapy or combine therapies. Photodynamic therapy (PDT) for the treatment of superficial nonhyperkeratotic AK lesions of the face and scalp involves application of a light-sensitive drug that is then activated by exposure to light of a specific wavelength. For PDT treatment of AKs, 5aminolevulinic acid (ALA) or methyl aminolevulinate (MAL) is applied to the lesion. Once absorbed by the lesion, ALA and MAL undergo conversion via the heme biosynthesis pathway to protoporphyrin IX (PpIX), which is an efficient photosensitizer and makes the treated tissue particularly susceptible to damage when exposed to a light source. One potential advantage of PDT, compared with peel and liquid nitrogen therapy, is its ability to be applied more selectively, thus sparing the surrounding skin from iatrogenic damage and reducing scarring. In addition, PDT can be used to treat multiple lesions simultaneously; and treatment can be repeated if necessary. Benign Skin Lesion Removal Sep 11 8 PDT with Metvixia consists of the topical application of methyl aminolevulinate (MAL) (in contrast to ALA used in the Kerastick procedure) followed by exposure with a red light source (in contrast to the blue light source in the Kerastick procedure). According to its FDA approval, Metvixia is indicated for treatment of nonhyperkeratotic actinic keratoses of the face and scalp in immunocompetent patients when used in conjunction with lesion preparation (debridement using a sharp dermal curette) in the physician’s office when other therapies are unacceptable or considered medically less appropriate. One Metvixia-PDT session consists of: lesion preparation, application of Metvixia Cream, application of occlusive dressing, occlusion for 3 hours, removal of excess cream with saline and positioning lamp and illumination with red light. During the time period between the application of Metvixia Cream and exposure to red light illumination, the treatment site will become photosensitive. The FDA approval of Metvixia cream plus illumination with the CureLight BroadBand was based on two clinical trials of 130 patients with non-hyperkeratotic actinic keratoses. Both trials were randomized, multicenter, and double-blinded with patients randomized to Metvixia -PDT and Vehicle-PDT study arms that required two treatment sessions (7 days apart). One study was conducted in the U.S. and patients were randomized 1:1 Metvixia to Vehicle and one study was conducted in Australia with patients randomized 4:1 Metvixia to Vehicle. In both studies treatment consisted of a multi-step process that was repeated after 7 days consisting of lesion preparation (debridement with sharp curette) to roughen the surface of the lesion, Metvixia or Vehicle Cream application to lesions with occlusion with an adhesive, non-absorbent dressing, waiting at least 2.5 hours, but no more than 4 hours to allow for conversion of the methyl aminolevulinate, removal of cream with gauze and saline, and red light Dosimetry and Illumination with the CureLight BroadBand Model CureLight 01 (a red light of 570 to 670 nm wavelength). Study patients had previously untreated facial and scalp actinic keratoses (AKs) that were slightly palpable (better felt than seen). Hyperkeratotic actinic keratoses were excluded. In the U.S. study 100% of patients had 4 to 10 lesions at baseline whereas in the Australian study, 63% (70/111) of patients had less than 4 lesions at baseline, 31% (34/111) had 4 to 10 lesions, and 6% (7/111) had more than 10 lesions at baseline (a maximum of 6 treatment fields were allowed in this study). A “Cleared” AK lesion was defined as being not visible and not palpable as assessed 3 months after the second treatment session. Patients with all treated lesions cleared at 3 months were defined as Complete Responders. In the Australian study, 86% (76/88) of patients had 75% or more lesions clear and 81% (71/88) were complete responders at three-month follow-up. In the U.S. study 83% (35/42) of patients had 75% or more lesions clear, and 79% (33/42) were complete responders at three-month follow-up. Patients with 4 or more lesions had lower success rates than those with less than 4 lesions when treated with PDT and Metvixia. In the Austrailian study, 67% (18/27) of patients with 4-10 lesions were complete responders whereas 79% (33/42) with 4-10 lesions were complete responders in the U.S. study. The FDA indicated data beyond the three-month follow-up was not available. The FDA also noted that pretreatment debridement could be an essential component of the therapy and, therefore, is included in the labeling for Metvixia Benign Skin Lesion Removal Sep 11 9 Szeimes et al (2009) investigated one hundred thirty-one patients with 4 to 10 nonpigmented, previously untreated thin or moderately thick AKs on the face or scalp in a multicenter, double-blind, randomized, placebo-controlled study. MAL or matching placebo cream was applied to the débrided lesion surface for 3 hours before illumination with noncoherent red light. Treatment was repeated 1 week later. Efficacy was evaluated in 57 patients with 418 lesions treated with MAL PDT and 58 with 414 lesions treated with placebo PDT. Sixteen patients were excluded as protocol violators (not randomized). The investigators reported that MAL PDT was superior to placebo PDT in lesion complete response rates (83.3% vs 28.7%) and patient complete response rates (all lesions showing complete response; 68.4% vs 6.9%). Pariser et al (2008) evaluated the efficacy of MAL PDT using red light-emitting diode light in a multicenter, double-blind, randomized study. A total of 49 patients with 363 AK lesions had 16.8% MAL cream applied under occlusion for 3 hours, and 47 patients with 360 AK lesions had vehicle cream similarly applied. The lesions were then illuminated with repeated treatment 1 week later. Complete lesion and patient (all lesions showing complete response) response rates were evaluated 3 months after last treatment. MAL PDT was superior to vehicle PDT with respect to lesion complete response (86.2% vs 52.2%) and patient complete response (59.2% vs 14.9%) Moloney and Collins (2007) compared the efficacy of 5-aminolaevlinic acid methylester (MAL) and 5-aminolaevulinic acid (ALA) PDT as treatment options for AK of the scalp. Sixteen male patients aged 59-87 years with extensive scalp AK were randomized into a double-blind, split-scalp prospective study. Two treatment fields were defined (right and left frontoparietal scalp) and treated 2 weeks apart. These fields were randomized to receive either MAL or ALA as first or second treatment. MAL cream was applied for 3 h; 20% ALA cream was applied for 5 h. A blinded observer assessed efficacy comparing AK counts before and 1 month after treatment. Pain was assessed using a visual analogue scale at 3, 6, 12 and 16 min. Fifteen patients completed treatment to both fields. There was a mean reduction from baseline in AK counts with the use of ALA-PDT of 6.2 +/- 1.9 compared with 5.6 +/3.2 with MAL-PDT. All patients experienced pain which was of greater intensity in the ALA-treated side at all time points. Similarly, duration of discomfort postprocedure persisted for longer following treatment with ALA when compared with MAL-PDT. The authors concluded that both ALA-PDT and MAL-PDT result in a significant reduction in scalp AK with no significant difference in efficacy. They also noted that ALA-PDT is more painful than MAL-PDT in the treatment of extensive scalp AK. According to British Association of Dermatologists Therapy Guidelines and Audit on the management of actinic keratoses, Photodynamic therapy is effective in up to 91% of AKs in trials comparing it with cryotherapy, with consistently good cosmetic result. Per the British Association of Dermatologists Guidelines for topical photodynamic therapy: Topical application of the prodrugs 5-aminolaevulinic acid (ALA) and methyl aminolaevulinate (MAL) is effective in cutaneous photodynamic therapy (PDT) (Strength of Recommendation A, Quality of Evidence I). Benign Skin Lesion Removal Sep 11 10 Currently, a range of light sources, doses and irradiances continues to be used in ALA-PDT, whereas in MAL-PDT the standard procedure now typically involves a light-emitting diode (LED) source. A range of continuous wave light sources is effective in topical PDT (Strength of recommendation A, Quality of evidence II-iii). Topical PDT is an effective therapy for thin and moderate thickness actinic keratoses (AK), with superiority to cryotherapy depending on protocol. Efficacy is relatively poorer for acral lesions, but PDT may still offer therapeutic benefit. Cosmetic outcome following PDT for AK is superior to cryotherapy (Strength of recommendation A, Quality of evidence I). Scientific Rationale - Update May 2006 Actinic keratoses (AKs) are rough, scaly, or warty, pre-cancerous skin lesions that occur primarily on sun-exposed skin surfaces. They are most common in older individuals with fair complexions, with a prevalence of >80% in fair skinned people over the age of 60. AKs appear as patches of hyperkeratosis with some surrounding erythema on sun-exposed areas of the head and neck, forearms and hands, and upper back. Treatment of AKs begins with prevention such as avoidance of sun exposure along with the use of sunscreens in an effort to reduce the development of AKs. Active treatment of AKs depends upon the size of the lesion and the number of lesions present. Some physicians choose to observe the lesions over time and remove them only if they exhibit specific clinical features suggesting possible transformation to invasive squamous cell carcinoma (SCC). The available treatments for actinic keratoses can generally be divided into surgical and non-surgical methods. Surgical treatments used to treat one or a small number of dispersed individual lesions include excision, cryosurgery, curettage (either alone or combined with electrodesiccation), and laser surgery. Non-surgical treatments include topical chemotherapy (5-fluorouracil or masoprocol creams), chemexfoliation (also known as chemical peels), and dermabrasion. These methods are generally used in patients with multiple lesions and the involvement of extensive areas of skin. Under some circumstances, combinations of different treatment methods may be used. In 1999, Levulan Kerastick, a topical preparation of ALA, in conjunction with illumination with the BLU-U Blue Light Photodynamic Therapy Illuminator, received approval by the U.S. Food and Drug Administration (FDA) for the treatment of nonhyperkeratotic actinic keratoses of the face and scalp. The technique involves two steps starting with application of the ALA Topical Solution in the physician's office. The package insert recommends that the application should involve either face or scalp lesions, but not both simultaneously. The patient is told to return in 14 to 18 hours, at which point the lesion is exposed to blue light for 17 minutes. During this period, the patient experiences sensations of tingling, stinging, or burning of the treated lesions. Treated lesions that have not completely resolved after 8 weeks may be treated a second time. As summarized in the package insert, two similarly designed studies randomized 243 patients with 4 to 15 non-hyperkeratotic actinic keratoses to receive Levulan Kerastick plus blue light exposure or a vehicle solution plus blue light exposure. From 63% to 69% of patients in the active treatment group reported complete response at 8 weeks, compared to 13% to 14% in the placebo group. Patients who were not complete responders after 8 weeks had retreatment of the persistent lesions. Among Benign Skin Lesion Removal Sep 11 11 these patients 43% showed a complete response after a second treatment, compared to only 4% in the placebo group. Scientific Rationale – Initial The term "benign" refers to a condition, tumor, or growth that is not cancerous. This means that it does not spread to other parts of the body or invade and destroy nearby tissue. Benign tumors usually grow slowly. In general, a benign tumor or condition is not harmful. However, this is not always the case. If a benign tumor is big enough, its size and weight can press on nearby blood vessels, nerves, or organs, or otherwise cause problems. Benign skin lesions are common and are frequently removed at the patient’s request to improve appearance. As such, excision of benign skin lesions that do not pose a threat to health or function are considered cosmetic. Seborrheic keratoses, also referred to as senile keratoses, are non-cancerous growths of the outer layer of skin. The origin is unknown. It commonly appears after age 40. The tumors appear as wart-like growths in a variety of colors. They may appear in large numbers on the surface of the body. They are usually painless and benign, but may become irritated and itch. They are usually brown, but can vary in color from beige to black, and vary in size from a fraction of an inch to more than an inch in diameter. They have the appearance of being glued or stuck on to skin. Seborrheic keratoses are most often found on the chest or back, although, they can also be found almost anywhere on the body. These become more common with age, and most elderly patients develop one or more of these lesions. Seborrheic keratoses can get irritated by clothing rubbing against them, and their removal may be appropriate if they itch, get irritated, or bleed easily. Although seborrheic keratoses are noncancerous, they may be difficult to distinguish from skin cancer if they turn black. Diagnosis is based primarily on the appearance of the growths. A skin lesion biopsy may be used to confirm the diagnosis. Seborrheic keratoses may be removed by cryosurgery, curretage, or electrosurgery. Particular growths usually do not recur after removal, but people who are prone to this condition may develop more in the future. Moles (nevi) are very common growths on the skin and can appear anywhere on the skin. Melanocytes are spread evenly throughout the skin and produce the pigment that gives skin its natural color. When skin is exposed to the sun, melanocytes produce more pigment, causing the skin to tan, or darken in a cluster with tissue surrounding them. They are usually brown in color, but can be skin colored or pink, light tan to brown, or blue-black. Moles may be flat or raised and can be various sizes and shapes and no larger than a pencil eraser. Most appear during the first 20 years of a person's life, although some may not appear until later in life. Sun exposure increases the number of moles. The majority of moles are benign. However, moles that raise suspicion of malignancy are those that significantly change in size, shape or color, and those that bleed, itch, or become painful. Atypical moles (dysplastic nevi) have an increased risk of developing into melanoma. Atypical moles are larger than average (> 6 mm) and irregular in shape. They tend to have uneven color with dark brown centers and lighter, sometimes reddish, uneven borders or black dots at edge. The most common methods of removal include shaving and excision. A sebaceous (keratinous) cyst is a slow-growing, closed sac found just under the skin containing "pasty" or "cheesy" looking skin secretions. The sebaceous cyst is firm, globular, movable, and nontender. These cysts seldom cause discomfort unless Benign Skin Lesion Removal Sep 11 12 the cyst ruptures or becomes infected. Ranging in size, sebaceous cysts are usually found on the scalp, face, ears, and genitals. They are formed when the release of sebum from the sebaceous glands in the skin is blocked. Unless they become infected and painful or large, sebaceous cysts do not require medical attention or treatment, and usually go away on their own. These cysts may occasionally become infected and form into painful abscesses. Infected cysts can be incised and drained, or the entire cyst may be surgically removed. Recurrence after excision is also not unusual. A skin tag (arochordon) is a small growth of tissue that is painless, soft, and moveable. It hangs from the surface of the skin on a thin piece of tissue called a stalk. The prevalence of skin tags increases with age. They appear most often in skin folds of the neck, armpits, trunk, beneath the breasts or in the genital region. They may become painful if thrombosed or if irritated. They may become irritated if they occur in an area where clothing or jewelry rubs against them. Skin tags may be removed by excision, cryosurgery, or electrosurgery. Warts (verruca vulgaris) are simply areas of skin that grow faster than normal due to the presence of the wart virus. Warts are skin-colored and feel rough to the touch. They are most common on the hands, feet and face but they can grow almost anywhere in the body. They are infectious and some people, especially children, are more susceptible than others. Flat warts are much smaller and are less rough than hand or foot warts. They tend to grow in great numbers - 20 to 100 at any one time. They can occur anywhere, but in children they are most common on the face. In adults they are most often found in the beard area in men and on the legs in women. Skin irritation from shaving probably accounts for this. A plantar wart is simply a wart growing on the weight-bearing surface of the foot that grows inward rather than outwards because it is pressed on when a person walks. As warts are caused by a virus infection, the body will build up resistance over a period of time and eventually the body will cause the warts to disappear. This may take months or sometimes years but is the natural way the body deals with warts. If they are allowed to disappear in this way it is less likely that a person will get any further ones as one will then be immune to that virus. The first treatment to try on warts is removal with a salicylic acid liquid or pad. A bottle of wart medication like Occlusal-HP or Compound W, a roll of 1-inch surgical tape ('Micropore' or 'Blenderm' are good) and a pumice stone or emery board can be tried next. One needs to keep going down until just below the level of the surrounding skin to eradicate a wart completely. When the base of the wart looks exactly like normal skin (i.e. no black dots or 'graininess), medication can be stopped. Liquid nitrogen cryotherapy is what dermatologists use most often to cure warts. This method can cause pain, soreness and blistering and usually cures 50% of warts after one treatment. Frequent applications of liquid nitrogen are needed to cure more stubborn warts. Burning warts off with a CO2 Laser or electric needle is often effective, but scars may result. HCPCS Codes N/A Review History June 8, 2004 May 2006 March 2007 August 2008 Medical Advisory Council, initial approval Change in position on treatment of Actinic Keratoses Code Update CA reconstructive surgery law added to disclaimer Benign Skin Lesion Removal Sep 11 13 September 2009 November 2009 January 2011 September 2011 Added PDT with topical Metvixia, followed by exposure to a red light source as medically necessary for treatment of Actinic Keratoses, when criteria is met for commercial members. Added separate Medicare criteria. Removed requirement of topical 5-FU or cryosurgery prior to photodynamic therapy with topical aminolevulinic acid (Levulan Kerastick) and exposure to blue light for non-hyperkeratotic actinic keratoses of the face and scalp. Added Medicare LCD link. No revisions. Update. Added Revised Medicare Table. No Revisions. Patient Education Websites English 1. American Academy of Dermatology. What are Actinic Keratoses. Available at: http://www.skincarephysicians.com/actinickeratosesnet/whatare.html Spanish 1. National Cancer Institute. Skin Cancer (PDQ): Treatment. Acesso en: http://www.cancer.gov/espanol/pdq/tratamiento/piel/patient This policy is based on the following evidence-based guidelines: 1. 2. 3. 4. National Institute for Health and Clinical Excellence. Photodynamic Therapy for Non-Melanoma Skin Tumors (Including Premalignant and Primary NonMetastatic Skin Lesions.) February 2006. Available at: http://www.nice.org.uk/page.aspx?o=IPG155guidance Morton CA, McKenna KE, Rhodes LE, British Association of Dermatologists Therapy Guidelines and Audit Subcommittee. Guidelines for topical photodynamic therapy: update. Br J Dermatol 2008 Dec; 159(6): 1245-66. Available at: http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=13568&nbr= 006940&string=photodynamic+AND+therapy de Berker D, McGregor JM, Hughes BR, British Association of Dermatologists Therapy Guidelines and Audit. Guidelines for the management of actinic keratoses. Br J Dermatol 2007 Feb; 156(2): 222-30. Available at: http://www.guideline.gov/summary/summary.aspx?doc_id=10831&nbr=005656 &string=actinic+AND+keratosis McIntyre W, Downs M, Bedwell S. Treatment Options for Actinic Keratoses. Am Fam Physician 2007;76:667-71, 672. Available at: http://www.aafp.org/afp/20070901/667.html References – Updated September 2011 1. 2. 3. 4. Goldstein BG, Goldstein AO. Overview of benign lesions of the skin. September 2, 2010. Available at: http://www.uptodate.com/contents/overview-of-benignlesions-of-the-skin?view=print Kumaraswamy KL, Vidhya M. Human papilloma virus and oral infections: An update. J Cancer Res Ther. 2011 Apr-Jun;7(2):120-7. Argenziano G, Zalaudek I, Hofmann-Wellenhof R, et al. Total body skin examination for skin cancer screening in patients with focused symptoms. J Am Acad Dermatol. 2011 Jul 12. [Epub ahead of print]. Matteucci P, Pinder R, Magdum A, et al. Accuracy in skin lesion diagnosis and the exclusion of malignancy. J Plast Reconstr Aesthet Surg. 2011 Jul 6. [Epub ahead of print] Benign Skin Lesion Removal Sep 11 14 References – Updated September 2009 1. Annemans L, Caekelbergh K, Roelandts R et al. Real-life practice study of the clinical outcome and cost-effectiveness of photodynamic therapy using methyl aminolevulinate (MAL-PDT) in the management of actinic keratosis and basal cell carcinoma. Eur J Dermatol. 2008 Sep-Oct; 18(5): 539-46. 2. Braathen LR, Paredes BE, Saksela O, et al. Short incubation with methyl aminolevulinate for photodynamic therapy of actinic keratoses. J Eur Acad Dermatol Venereol. 2009 May; 23(5): 550-5. 3. Fernández-Guarino M, Harto A, Sánchez-Ronco M, et al. Retrospective, descriptive, observational study of treatment of multiple actinic keratoses with topical methyl aminolevulinate and red light: results in clinical practice and correlation with fluorescence imaging. Actas Dermosifiliogr. 2008 Dec; 99(10): 779-87. 4. Hayes Medical Technology Directory. Photodynamic Therapy for Actinic Keratoses. May 2004. Updated Oct. 2008. 5. Kasche A, Luderschmidt S, Ring J, Hein R. Photodynamic therapy induces less pain in patients treated with methyl aminolevulinate compared to aminolevulinic acid. J Drugs Dermatol. 2006 Apr; 5(4): 353-6. 6. Kaufmann R, Spelman L, Weightman W et al. Multicentre intraindividual randomized trial of topical methyl aminolaevulinate-photodynamic therapy vs. cryotherapy for multiple actinic keratoses on the extremities. Br J Dermatol. 2008 May; 158(5): 994-9 7. Lehmann P. Methyl aminolaevulinate-photodynamic therapy: a review of clinical trials in the treatment of actinic keratoses and nonmelanoma skin cancer. Br J Dermatol. 2007 May; 156(5): 793-801 8. Moloney FJ, Collins P. Randomized, double-blind, prospective study to compare topical 5-aminolaevulinic acid methylester with topical 5-aminolaevulinic acid photodynamic therapy for extensive scalp actinic keratosis. Br J Dermatol. 2007 Jul; 157(1): 87-91 9. Morton C, Campbell S, Gupta G, et al. Intraindividual, right-left comparison of topical methyl aminolaevulinate-photodynamic therapy and cryotherapy in subjects with actinic keratoses: a multicentre, randomized controlled study. Br J Dermatol 2006; 155:1029. 10. Morton, CA. Methyl aminolevulinate: actinic keratoses and Bowen's disease. Dermatol Clin 2007; 25:81Ortiz-Policarpio B, Lui H. Methyl aminolevulinate-PDT for actinic keratoses and superficial nonmelanoma skin cancers. Skin Therapy Lett. 2009 Jul-Aug; 14(6): 1-3. 11. Pariser D, Loss R, Jarratt M et al. Topical methyl-aminolevulinate photodynamic therapy using red light-emitting diode light for treatment of multiple actinic keratoses: A randomized, double-blind, placebo-controlled study. J Am Acad Dermatol. 2008 Oct; 59(4): 569-76. 12. Piacquadio DJ, Chen DM, Farber HF et al. Photodynamic therapy with aminolevulinic acid topical solution and visible blue light in the treatment of multiple actinic keratoses of the face and scalp: investigator-blinded, phase 3, multicenter trials. Arch Dermatol. 2004 Jan;140(1):41-6 13. Smith S, Piacquadio D, Morhenn V et al. 3: Short incubation PDT versus 5-FU in treating actinic keratoses. J Drugs Dermatol. 2003 Dec;2(6):629-35. 14. Smits T, Moor AC. New aspects in photodynamic therapy of actinic keratoses. 15. J Photochem Photobiol B. 2009 Jun 13 16. Szeimies RM, Matheson RT, Davis SA et al. Topical methyl aminolevulinate photodynamic therapy using red light-emitting diode light for multiple actinic keratoses: a randomized study. Dermatol Surg. 2009 Apr; 35(4): 586-92 Benign Skin Lesion Removal Sep 11 15 17. Tarstedt M, Rosdahl I, Berne B et al. A randomized multicenter study to compare two treatment regimens of topical methyl aminolevulinate (Metvix)-PDT in actinic keratosis of the face and scalp. Acta Derm Venereol. 2005; 85(5): 424-8. 18. Tschen EH, Wong DS, Pariser DM et al. Photodynamic therapy using aminolaevulinic acid for patients with nonhyperkeratotic actinic keratoses of the face and scalp: phase IV multicentre clinical trial with 12-month follow up. Br J Dermatol. 2006 Dec; 155(6): 1262-9. 19. Tschen EH, Wong DS, Pariser DM et al. 1: Photodynamic therapy using aminolaevulinic acid for patients with nonhyperkeratotic actinic keratoses of the face and scalp: phase IV multicentre clinical trial with 12-month follow up. Br J Dermatol. 2006 Dec;155(6):1262-9. 20. United States Food and Drug Administration. Metvixia. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Se arch.DrugDetails 21. Wennberg AM, Stenquist B, Stockfleth E, et al. Photodynamic therapy with methyl aminolevulinate for prevention of new skin lesions in transplant recipients: a randomized study. Transplantation. 2008 Aug 15; 86(3): 423-9. 22. Centers for Medicare and Medicaid Services. NCD for Treatment of Actinic Keratosis (AKs). Nov. 2001 Available at: 23. http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=250.4&ncd_version=1&baske t=ncd%3A250%2E4%3A1%3ATreatment+of+Actinic+Keratosis+%28AKs%29 24. Centers for Medicare and Medicaid Services. LCD for Removal of Benign Skin Lesions. July 2009. Available at: http://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=27362&lcd_version=22&baske t=lcd%3A27362%3A22%3ARemoval+of+Benign+Skin+Lesions%3AMAC+%2D+ Part+A%3ANational+Government+Services%7C%7C+Inc%2E+%2813101%29 %3A References – Updated May 2006 1. Babilas P, Karrer S, Sidoroff A, et al. Photodynamic therapy in dermatology--an update. Photodermatol Photoimmunol Photomed. 2005 Jun;21(3):142-9. 2. US. Food and Drug Administration. Levulan Kerastick. Accessed May 2006. Available at: http://www.fda.gov/cder/foi/label/1999/20965lbl.pdf 3. Hayes Alert - Technology Assessment Brief. Photodynamic Therapy for Acne Vulgaris.Volume VIII, Number 8 - August 2005. Accessed May 2006. Available at: http://www.hayesinc.com/subscribers/searchArticles.do 4. Garcia-Zuazaga J, Cooper KD, Baron ED. Photodynamic therapy in dermatology: current concepts in the treatment of skin cancer. Expert Rev Anticancer Ther. 2005 Oct;5(5):791-800 5. Gilaberte Y, Serra-Guillen C, De Las Heras ME, et al. Photodynamic therapy in dermatology. Actas Dermosifiliogr. 2006 Mar;97(2):83-102 6. Gold MH, Nestor MS. Current treatments of actinic keratosis. J Drugs Dermatol. 2006 Feb;5(2 Suppl):17-25. 7. Jeffes, EW, McCullough, JL, Weinstein, GD, et al. Photodynamic therapy of actinic keratoses with topical aminolevulinic acid hydrochloride and fluorescent blue light. J Am Acad Dermatol 2001; 45:96. 8. Kasche A, Luderschmidt S, Ring J, Hein R. Photodynamic therapy induces less pain in patients treated with methyl aminolevulinate compared to aminolevulinic acid. J Drugs Dermatol. 2006 Apr;5(4):353-6. 9. Langan SM, Collins P. Randomized, double-blind, placebo-controlled prospective study of the efficacy of topical anaesthesia with a eutetic mixture of lignocaine 2.5% and prilocaine 2.5% for topical 5-aminolaevulinic acid-photodynamic Benign Skin Lesion Removal Sep 11 16 therapy for extensive scalp actinic keratoses. Br J Dermatol. 2006 Jan;154(1):146-9. 10. Melnick S. Cystic acne improved by photodynamic therapy with short-contact 5aminolevulinic acid and sequential combination of intense pulsed light and blue light activation. J Drugs Dermatol. 2005 Nov-Dec;4(6):742-5. 11. Radakovic-Fijan S, Blecha-Thalhammer U, Kittler H, et al. Efficacy of 3 different light doses in the treatment of actinic keratosis with 5-aminolevulinic acid photodynamic therapy: a randomized, observer-blinded, intrapatient, comparison study. J Am Acad Dermatol. 2005 Nov;53(5):823-7. 12. Sekula-Gibbs S, Uptmore D, Otillar L. Retinoids. J Am Acad Dermatol. 2004 Mar;50(3):405-15 13. Zakhary K, Ellis DA. Applications of aminolevulinic Acid-based photodynamic therapy in cosmetic facial plastic practices. Facial Plast Surg. 2005 May;21(2):110-6. References - Initial 1. Luba MC, M.D., Bangs SA. Common Benign Skin Tumors. Am Fam Physician 2003;67:729-38. 2. Andrews MD. Cryosurgery for common skin conditions. Am Fam Physician. 2004 May 15;69(10):2365-72. 3. Kelley LC, Hruza GJ. Benign skin tumors. Facial Plast Surg Clin North Am. 2003 May;11(2):243-51. 4. De Gannes GC, Ip JL, Martinka M, et al. Early Detection of Skin Cancer by Family Physicians: A Pilot Project. J Cutan Med Surg. 2004 Mar 25 5. Beers MH, Berkow R, eds. Disorders of hair follicles and sebaceous glands: Keratinous cyst. In: The Merck Manual of Diagnosis and Therapy. 17th ed. Sec. 10, Ch. 116. White House Station, NJ: Merck; 2002. 6. Berg P, Lindelof B. Congenital nevocytic nevi: Follow-up of a Swedish birth register sample regarding etiologic factors, discomfort, and removal rate. Pediatr Dermatol. 2002;19(4):293-297. 7. Bader RS, Scarborough DA. Surgical pearl: intralesional electrodesiccation of sebaceous hyperplasia. J Am Acad Dermatol 2000;42(1 Pt 1):127-8. 8. Christenson L, Patterson J, Davis D. Surgical pearl: use of the cutaneous punch for the removal of lipomas. J Am Acad Dermatol 2000;42:675-6. 9. Dinehart SM. Actinic keratoses: scientific evaluation and public health implications. Journal of the American Academy of Dermatology. 2000;42(1):25-8 10. Plunkett A, Merlin K, Gill D, Zuo Y, Jolley D, Marks R. The frequency of common nonmalignant skin conditions in adults in central Victoria, Australia. Int J Dermatol 1999;38:901-8. 11. Rosenthal TC, Kraybill W. Soft tissue sarcomas: integrating primary care recognition with tertiary care center treatment. Am Fam Physician 1999;60: 56772. 12. Feldman SR, Fleischer AB, Williford PM, Jorizza JL. Clinical and laboratory studies; destructive procedures are the standard of care for treatment of actinic keratoses. Journal of the American Academy of Dermatology. 1999;40(1):43-7 13. Signorini M, Campiglio GL. Posttraumatic lipomas: where do they really come from? Plast Reconstr Surg 1998;101:699-705. 14. Pariser RJ. Benign neoplasms of the skin. Med Clin North Am 1998;82:1285-307. 15. Manstein CH, Frauenhoffer CJ, Besden JE. Keratoacanthoma: is it a real entity? Ann Plast Surg 1998;40:469-72. 16. Canas GC, Robson KJ, Arpey CJ. Persistent keratoacanthoma: challenges in management. Dermatol Surg 1998;24:1364-9. Benign Skin Lesion Removal Sep 11 17 17. Miller AM, Sahl WJ, Brown SA, Young SK, Quinlan CM, Patel PR, et al. The role of human papillomavirus in the development of pyogenic granulomas. Int J Dermatol 1997;36:673-6. 18. Requena L, Sangueza OP. Cutaneous vascular proliferation. Part II. Hyperplasias and benign neoplasms. J Am Acad Dermatol 1997;37:887-919. 19. Callen JP, Bickers DR, Moy RL. From the academy; actinic keratoses. Journal of the American Academy of Dermatology. 1997;36(4):650-3 20. Drake LA et al. Academy guidelines: guidelines of care for photoaging/photodamage. Journal of the American Academy of Dermatology. 1996;35(3):462-464 21. de Berker DA, Taylor AE, Quinn AG, Simpson NB. Sebaceous hyperplasia in organ transplant recipients: shared aspects of hyperplastic and dysplastic processes? J Am Acad Dermatol 1996;35(5 Pt 1):696-9. 22. Weiss SW. Lipomatous tumors. Monogr Pathol 1996;38:207-39. 23. Schwartz RA. Keratoacanthoma. J Am Acad Dermatol 1994;30:1-19. 24. Rosian R, Goslen JB, Brodell RT. The treatment of benign sebaceous hyperplasia with the topical application of bichloracetic acid. J Dermatol Surg Oncol 1991;17:876-9. 25. Patrice SJ, Wiss K, Mulliken JB. Pyogenic granuloma (lobular capillary hemangioma): a clinicopathologic study of 178 cases. Pediatr Dermatol 1991;8:267-76. 26. Scott MA. Benign cutaneous neoplasms. Prim Care 1989;16:645-63. 27. Lanigan SW, Robinson TW. Cryotherapy for dermatofibromas. Clin Exp Dermatol 1987;12:121-3. 28. Rydholm A, Berg NO. Size, site and clinical incidence of lipoma. Factors in the differential diagnosis of lipoma and sarcoma. Acta Orthop Scand 1983;54:929-34. 29. Myhre-Jensen O. A consecutive 7-year series of 1331 benign soft tissue tumours. Clinicopathologic data. Comparison with sarcomas. Acta Orthop Scand 1981;52:287-93. 30. Taira JW, Hill TL, Everett MA. Lobular capillary hemangioma (pyogenic granuloma) with satellitosis. J Am Acad Dermatol 1992;27(2 Pt 2):297-300. 31. Gonzalez S, Vibhagool C, Falo LD Jr, Momtaz KT, Grevelink J, Gonzalez E. Treatment of pyogenic granulomas with the 585 nm pulsed dye laser. J Am Acad Dermatol 1996;35(3 Pt 1):428-31. 32. Crile G Jr. Thirteen shortcuts in office surgery. Surg Clin North Am 1975;55:1025-9. 33. Zuber TJ. Minimal excision technique for epidermoid (sebaceous) cysts. Am Fam Physician 2002; 65:1409-12. 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 Benign Skin Lesion Removal Sep 11 18 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. 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. 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. 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. 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. Coverage decisions are the result of the terms and conditions of the Member’s benefit contract. The Policies do not replace or amend the Member’s contract. If there is a discrepancy between the Policies and the Member’s contract, the Member’s contract shall govern. 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. California 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. 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 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. Benign Skin Lesion Removal Sep 11 19
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