Oscar Treatment and Removal of Benign Skin Lesions (CG015) Form

The Integumentary System

The integumentary system is comprised of the skin, hair, and nails. The skin is divided into three layers: the epidermis, dermis, and subcutaneous fat; diseases of these protective outer layers are among the most common conditions worldwide. Lesions of the skin can be either benign (non-malignant), pre-malignant (potential for evolving into malignancy), or malignant (cancerous). Such lesions arise from congenital malformations or are acquired, often due to extensive ultraviolet light (UV) exposure or underlying illness. Diagnosis is primarily through history, clinical exam, and the appearance of the lesion(s). While the vast majority of benign lesions require no intervention, some cases may necessitate intervention due to bothersome symptoms, for definitive diagnosis, or for exclusion of malignant features. The treatment of these benign lesions can consist of simple biopsy up to radical excision or destruction, where lasers, electrosurgery, or liquid nitrogen may also be utilized. Premalignant and malignant skin lesions are not addressed in this guideline.

Definitions

"ABCDE" is a model for clinical suspicion. Lesions meeting any of these criteria are considered suspicious for malignancy and may require intervention:

• Asymmetry: one half of the mole or lesion appears different from the other half;
• Border: the edges of a mole or lesion are irregular, ragged, blurred;
• Color: the color of the lesion is variable and lacks uniformity; the color is not the same all over and may include shades of brown or black or sometimes have patches of pink, red, white or blue;
• Diameter: the mole of lesion is greater than 6mm across;
• Evolution: the size, shape, or color has undergone change

"Benign Skin Lesions" are those with minimal risk of malignant transformation and commonly require no intervention in a majority of individuals. Includes, but not limited to, the following:

• Acne (glands and hair follicles plugged with oil and dead skin cells)
• Acquired or small (<1.5cm) congenital nevi (pigmented mole on skin)
• Acrochordons (skin tags)
• Cherry angioma (capillary proliferations)
• Dermatofibroma (subcutaneous tissue lesion)
• Epidermoid cysts ("sebaceous" cysts, epidermal inclusion cysts)
• Erythematotelangiectatic rosacea (transient flushing, persistent central facial erythema, and telangiectasias)
• Hemangioma (superficial or deep proliferation of blood vessels)
• Keloids (excessive tissue growth)
• Lipoma (mature fat cells enclosed by thin fibrous capsules)
• Neurofibroma (cutaneous or subcutaneous nerve sheath tumor that forms soft bumps on or under the skin)
• Nevus flammeus (port-wine stain)
• Nevus simplex (macular stain)
• Pyogenic granuloma (capillary hemangioma characterized by rapid growth and friable surface)
• Pilomatricoma/Pilomatrixoma (nodules/papules associated with hair follicles)
• Seborrheic keratosis ("senile wart")
• Telangiectasia (dilation of small blood vessels)
• Trichodermal cyst / Trichilemmal cyst / Pilar cyst is located in the dermis and is a slow-growing subcutaneous node that originates from the outer hair root sheath. It resembles epidermoid cysts and is commonly found on the scalp.

"Cosmetic" refers to a procedure done to enhance or alter human anatomy/appearance in a non-natural form or to repair a "defect" that is within the normal variation of anatomical form. Cosmetic surgery does not include reconstructive surgery that is incidental to or follows surgery resulting from trauma, infection or diseases of the involved part or reconstructive surgery due to a congenital disease or anomaly of a covered child that has resulted in a functional defect.

"Mole Mapping/Total Body Photography (TBP) and Dermatoscopy/Dermoscopy" refer to visual or digital aids used by dermatologists.

Examples

Examples include total body imaging, skin surface microscopy, digital epiluminescence microscopy (DELM), epiluminescence microscopy (ELM), and incidence light microscopy.

"Pterygium"

is a benign growth of the eye.

"Photodynamic Therapy"

refers to the combination of topical photosensitizers (e.g., aminolevulinic acid) followed by illumination with visible light to activate the drug and destroy the target tissue. Photodynamic therapy may also be called photoradiation therapy, phototherapy, or photochemotherapy.

Premalignant Skin Lesions

• "Actinic Keratosis" appears as a rough, scaly patch. Commonly seen after long-term UV exposure. There is a risk of malignant transformation if untreated.
• "Lentigo Maligna" is essentially a melanoma in situ, meaning that it contains malignant cells but without any invasive growth. Can progress to invasive melanoma. Occurs primarily in elderly individuals with UV exposure and is often found on the face and neck.
• "Leukoplakia" are predominantly white patches of thickened skin, often in the oral region. There is a significant risk of malignant transformation. Associate with alcohol and tobacco usage.
• "Squamous Cell Carcinoma In-Situ (Bowen's Disease)" appears as a flat, red, scaly growth. Common in elderly individuals and is considered a pre-malignant form of squamous cell carcinoma found in the outermost layer of skin.

"Reconstructive"

refers to a procedure to restore normal human anatomy/appearance/physiology after trauma, accidental injury, disease, or congenital defect. Normal skin appearance may include slight variation, scars, and genetic or age-associated skin changes.

"Removal and biopsy"

preserve tissue (i.e., sent for pathological analysis) while destructive techniques destroy the lesion.

"Skin Lesions"

is a nonspecific term that refers to any change in the skin surface that may be benign, premalignant or malignant.

Surgical Treatment for Benign Skin Lesions:

• "Cryosurgery" refers to the use of liquid nitrogen (or argon) to freeze (destroy) a lesion.
• "Electrosurgery" refers to the use of electric current to remove or destroy lesions; can be associated with electrocautery to stop bleeding (e.g., Bovie device).
• "Laser Surgery" refers to the use of laser technology to destroy lesions (e.g., pulsed carbon dioxide (CO2) laser, erbium yttrium aluminium garnet (YAG) laser, 755 nm alexandrite laser, and 532 nm diode laser, etc.).
• "Surgical Curettement or Excision" refers to the use of a surgical instrument (e.g., curette or scalpel) to remove lesions.

"Topical Therapy"

refers to the use of topical agents (e.g., 5-fluorouracil) to destroy certain lesions. Topical agents are commonly used as a first line therapy for benign skin lesions and may be subject to the formulary and criteria outlined in the pharmacy benefit.

"Warts"

are caused by various subtypes of the human papillomavirus (HPV) that can form in the mucosa and skin. There are many types of warts such as verruca vulgaris/common warts, verruca palmaris/palmar warts, verruca plana/flat warts, verruca plantaris/plantar warts, etc.

Clinical Indications

Surgical Treatment (i.e., cryosurgery, electrosurgery, laser surgery, or surgical curettement or excision) for Benign Skin Lesions

Surgical treatment of benign skin lesions is considered medically necessary when ALL of the following criteria are met:

1. Removal is expected to reasonably improve the physical or functional impairment (not for cosmetic appearance); and
2. There is clear documentation of medical necessity containing written description of the surgically treated lesion with respect to location, physical characteristics, and rationale for intervention. This must include a specific diagnosis and documentation of size changes via patient history, medical record, or in-office measurement; and

1. Any one of the following criteria are met and documented in the medical record:
   • Prior biopsy suggests premalignancy or malignancy; or
   • There is recurrent trauma/irritation/discomfort due to lesion location (e.g., bra line, waistband); or
   • The lesion clinically appears to be pre-malignant (e.g., actinic keratoses, large or changing congenital or acquired nevi, Bowen’s disease, dysplastic lesions, lentigo maligna, leukoplakia) or malignant (due to ABCDE criteria, or associated symptoms, especially in patients with personal/family history of melanoma); or
   • Note: In cases where the diagnosis is uncertain, biopsy or removal is more medically appropriate than destruction.
   • The lesion is persistently symptomatic (e.g., bleeding, burning, itching, pain); or
   • The lesion shows evidence of inflammation (e.g., edema, erythema, purulence); or
   • The lesion is infectious (verruca vulgaris) (especially in immunocompromised patients); or
   • The lesion restricts vision (e.g., restricts eyelid function, misdirects eyelashes/eyelids, interferes with tear ducts, or touches globe), restricts breathing or eating (near or on the nares or lips) or obstructs a body orifice.
2. Pterygium removal is medically necessary in cases of increased growth towards the center of cornea and/or when the lesion results in functional deficit (visual impairment, restriction of eye movement, irritation).
3. Wart removal is considered medically necessary when ONE of the following criteria are met:
   • Warts (HPV mediated e.g., verruca vulgaris/common warts, verruca palmaris/palmar warts, verruca plana/flat warts, verruca plantaris/plantar warts, etc.),
   • Periocular warts associated with chronic recurrent conjunctivitis thought to be secondary to lesion viral shedding; or
   • Lesions consistent with molluscum contagiosum are considered medically necessary for removal if one of the following criteria are met:
     • Symptomatic (e.g., spreading, pain, irritation); or
     • Immunocompromised patient; or
     • After a trial and failure of over the counter measure; or
     • Note: Molluscum contagiosum is caused by a virus and is almost always self-limited in children, to the extent that most members do not require, and/or do not respond to treatment.
   • Lesions consistent with condyloma acuminata (genital warts).
4. Scar removal (e.g., excision or destruction) is considered medically necessary after the scar has tried and failed conservative therapy (topical or intralesional injections) for reduction in symptoms or size AND if one of the following criteria are met:
   • The lesion interferes with normal bodily function; or
   • The lesion causes pain or irritation; or
   • Removal is intended to correct functional physical impairment, including pain, burning, itching, or other impairing symptoms due to inflammation (not for cosmetic appearance).
5. Tattoos: Tattoo application is medically necessary when it is a component of a medically necessary treatment such as radiation therapy or as part of a covered breast reconstruction.
6. Trichodermal cyst / Trichilemmal cyst / Pilar cyst removal is considered medically necessary after trial and failure of conservative therapy and the cyst is persistently symptomatic (infection, pain, irritation, etc.,).

Experimental or Investigational / Not Medically Necessary

Any lesion or condition not meeting the criteria discussed above is NOT medically necessary.

Routine foot care for cosmetic purposes is considered not medically necessary.

This includes the shaving and/or excision of benign plantar hyperkeratotic lesions (calluses) absent of persistent symptoms.

Procedures performed for subjective cosmetic reasons, for being bothersome, for being unsightly, or for non-physical, social or emotional distress are considered not medically necessary. Cosmetic services are considered not medically necessary.⁵

The following services are therefore not medically necessary for benign skin lesions:

• Procedures performed only to improve physical appearance such as in acne scars, uneven pigmentation, and/or photoaging (wrinkles)
• Tattoo removal
• Laser skin resurfacing
• Chemical peels
• Non-surgical light and laser therapy (including intense pulsed light therapy), unless otherwise indicated above
• Dermabrasion
• Photodynamic Therapy
• Ultrasonographic evaluation of photoaging and rejuvenation techniques

The following approaches are considered experimental and investigational:

• Computerized Total Body Photography (TBP) systems (e.g., MelaFind, MoleMapCD, MoleMate, MoleSafe)
• Conventional total body photography (TBP) and dermoscopy
• Confocal Scanning Laser Microscopy
• Electrical impedance device
• High-resolution ultrasonography
• Multi-photon laser scanning microscopy (also known as multi-photon fluorescence microscopy or multi-photon excitation microscopy)
• Multi-spectral image analysis
• Optical coherence tomography
• Spectroscopy
• Visual image analysis

Rallan D, Harland CC. found that computer-assisted diagnosis of pigmented lesions was at best equivalent to human diagnosis and that other optical imaging techniques had yet to demonstrate a proven role in diagnosis, treatment, and monitoring of existing disease. Others have echoed these findings (Marchesini R, Bono A, Bartoli C, et al. ).