LCD L35090: Cosmetic and Reconstructive Surgery

Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

According to the American Society of Plastic Surgeons (ASPS), the specialty of plastic surgery contains two main categories which are cosmetic surgery and reconstructive surgery. 1

Cosmetic Surgery

Cosmetic surgery is performed to reshape and adjust normal structures of the body to enhance the visual appearance. Please refer to CMS IOM Publication 100-02, Medicare Benefit Policy Manual , Chapter 16, Section 120 Cosmetic Surgery for detailed information.

Reconstructive Surgery

Reconstructive surgery is performed to restore and improve function and correct any deformities or abnormal structures of the body that have been caused by congenital defects, developmental abnormalities, trauma, infection, tumors or disease.

Dermabrasion

Dermabrasion is a form of skin resurfacing used to remove damaged skin and promote normal wound healing and skin rejuvenation. Standard dermabrasion uses a wire brush or a stainless steel wheel on which diamond chips have been bonded (diamond fraise) abraders to plane the skin 2 whereas laser dermabrasion involves use of the argon laser, ultrapulse carbon dioxide (CO2) laser, 3 or flashlamp-pumped pulsed dye laser. The literature speaks to interventions to promote a more controlled wound healing process to avoid altered or dysregulated wound healing which is, characterized by prolonged or increased inflammation and is correlated with an overproduction of immature collagen III in contrast to mature collagen I which results in increased tissue fibrosis. The literature notes that there is a higher prevalence of hypertrophic scars occurring after burn injuries. Dysregulated healing leads to a hypertrophic scar which can be defined as a scar forming after injury that is larger or more raised than usual, or that results in contracture. Hypertrophic scar is more likely to occur after infection of the wound, closure of the wound with excessive tension, or with position of the wound in areas of skin with high natural tension; such as the shoulders, neck, and sternum. 3

Abdominal Lipectomy/Panniculectomy

Abdominal Lipectomy/Panniculectomy are surgical removal of hanging excessive fat and skin in a transverse or vertical wedge from the abdomen but does not include muscle plication or flap elevation. This surgery is considered reconstructive when it is performed to alleviate such complicating factors as inability to walk normally, chronic pain, ulceration created by the abdominal skin fold, or intertrigo dermatitis (dermatitis occurring on opposed surfaces of the skin, skin irritation, infection or chafing). This procedure may be done after weight loss surgery where there has been a great deal of weight loss with significant skin redundancy with complicating factors as above.

Reconstructive Breast Surgery - Removal of Breast Implants

Reconstructive breast surgery is a surgical procedure that is designed to restore the normal appearance of a breast after a medically necessary mastectomy for breast cancer or other medical condition, injury or congenital abnormality, or unilateral hypertrophy resulting in symptoms following contralateral mastectomy. Surgery that is necessary to reduce the size of a normal contralateral breast to bring it into symmetry with a breast reconstructed after cancer surgery is considered reconstructive. In contrast, cosmetic breast surgery is defined as surgery designed to alter or enhance the appearance of a breast that has not undergone a medically reasonable and necessary surgery, an accidental injury/trauma, congenital defect, infection or other non-malignant disease.

Complications related to breast implants may potentially increase over time which could result in the need for removal. 4

Some examples of complications associated with breast implants are:

• Capsular contracture which is the hardening of the breast tissue around the implant that could cause the tissue to tighten and cause pain.

• Rupture and deflation which is a hole or tear in the outer shell of the implant that can be caused by many different situations such as, but not limited to, capsule contracture, damage during procedures to the breast, physical stresses or trauma, etc.

• Infection which can occur within a few days, weeks, or any time after surgery. Some infections may not respond to antibiotics which could result in the implant needing to be removed.

Reduction Mammaplasty

Macromastia (breast hypertrophy) is an increase in the volume and weight of breast tissue relative to the general body habitus. Breast hypertrophy may adversely affect other body systems (e.g., musculoskeletal, respiratory, integumentary). At times, unilateral hypertrophy may result in symptoms following contralateral mastectomy. Considerable attention has been given to the amount of breast tissue removed in differentiating between cosmetic and medically reasonable and necessary reduction mammoplasty. Arbitrary minimum weight breast tissue removed criteria do not consistently reflect the consequences of mammary hypertrophy in individuals with a unique body habitus. 5 There are wide variations in the range of height, weight and associated breast size that cause symptoms. The amount of tissue that must be removed to relieve symptoms will vary and depend upon these variations.

The Schnur sliding scale is an evaluation method for physicians to use on individuals considering breast reduction surgery. If the individual's body surface area and weight of breast tissue removed fall above the 22nd percentile, then the surgery is considered medically reasonable and necessary with the appropriate criteria. 5 The scale abbreviated below allows a rough estimate of the minimal amount of soft tissue to be removed to justify surgery to alleviate symptoms based on body surface area; breast tissue may be removed from the other breast in order to achieve symmetry.

SCHNUR SCALE:

Body Surface Area (m 2 )

Average grams of tissue to be removed per breast

1.40-1.90

324-780g

1.91-2.00

795-935g

2.01-2.30

950-1000g

BSA>2.31

>1000g

Gestational or pregnancy-included gigantomastia occurs during pregnancy. This subtype is thought to be triggered by pregnancy hormones, usually during the first trimester. It occurs in just 1 out of every 100,000 pregnancies. 6 Gigantomastia may be defined as the excessive overgrowth of breast tissue per breast unilaterally or bilaterally, however, there is no universally accepted definition for the amount of growth. Gigantomastia has been associated with pregnancy, puberty, certain medications and certain autoimmune conditions. Extreme breast enlargement and excess weight of the breasts can result in physical complications including overstretching of the skin, skin rashes under the breasts, ulcers on the skin, neck, shoulder and back pain, headaches, mastalgia, breast asymmetry, temporary or permanent nerve damage, psychological, emotional and social problems. Hormonal treatment or a combination of treatments may be performed to reduce the size of the breasts and help ameliorate symptoms caused by hypertrophy of the breast(s). Literature review has shown that puberty and pregnancy-included gigantomastia may reoccur after breast reduction surgery and that mastectomy is a more final treatment for gigantomastia. 7 A reduction mammoplasty or mastectomy with or without reconstruction is considered medically reasonable and necessary.

Gynecomastia

Gynecomastia is defined as a unilateral or bilateral persistent benign mammary gland enlargement in men. Typically true gynecomastia presents with a solid tissue mass palpable below the nipple-areolar complex. Malignant changes such as male mammary carcinoma must always be ruled out. 8 There are numerous causes of gynecomastia. One cause is noted to be the imbalance of female to male hormones which triggers the onset of the disease. Endogenous causes may be hyperthyroidism, chronic liver disease, primary or secondary gonadal failure, androgen resistance syndromes, medication and drug abuse. A series of heart or hypertension medications can also trigger gynecomastia. The prevalence of asymptomatic gynecomastia is up to 65% and true gynecomastia must be distinguished from pseudo-gynecomastia. 9 This condition can cause significant clinical manifestations when the excessive breast weight adversely affects the supporting structures of the shoulders, neck, and trunk. Depending on the underlying cause, the therapy of gynecomastia may be conservative or surgical. 9 Medical treatment of pathological gynecomastia depends upon the cause. There are times when a gynecomastia procedure will require a more extensive mastectomy. Suction assisted lipectomy may be used as the primary method of removing excess tissue or as an adjunctive procedure to contour the anterior chest wall. 10 Mastectomy with nipple preservation or reduction mammoplasty is considered reconstructive and medically reasonable and necessary for males with gynecomastia Grade III and IV as defined on the ASPS gynecomastia scale or symptomatology or signs of deformity related to excess size.

American Society of Plastic Surgeons’ gynecomastia scale (ASPS, 2015):

• Grade II: Moderate breast enlargement exceeding areola boundaries with edges that are indistinct from the chest.

• Grade III: Moderate breast enlargement exceeding areola boundaries with edges that are indistinct from the chest with skin redundancy present.

• Grade IV: Marked breast enlargement with skin redundancy and feminization of the breast

Rhinoplasty/Reconstructive Nasal Surgery

Nasal surgery is any procedure performed on the external or internal structures of the nose, septum or turbinate. This surgery may be performed to improve abnormal function, reconstruct congenital or acquired deformities, or to enhance appearance. When nasal surgery is performed to improve nasal respiratory function, correct anatomic abnormalities caused by birth defects or disease, or revise structural deformities produced by trauma, the procedure is considered reconstructive.

Rhinoplasty is a procedure that changes the shape or appearance of the nose while improving or preserving the nasal airway. The primary purpose for rhinoplasty can be functional, aesthetic, or both and may include other procedures on the paranasal sinuses, septum, or turbinates. 11

Septoplasty is a procedure used to correct deformities of the nasal septum which can often cause issues with airflow and difficulty breathing.

Covered Indications

The following reconstructive procedures are considered medically reasonable and necessary:

• Dermabrasion

• Dermabrasion is considered medically reasonable and necessary for the treatment of rhinophyma. Rhinophyma is characterized by skin thickening, which can cause an enlargement of the nose due to excess tissue and overgrowth of sebaceous glands. 12 Rhinophyma may pose functional problems such as nasal airway obstruction, including sleep apnea. 13,14

• Abdominal Lipectomy/Panniculectomy

• Abdominal lipectomy/panniculectomy is considered medically reasonable and necessary when the pannus or panniculus hangs below the level of the symphysis pubis causing one or more of the following conditions:

• Chronic intertrigo that consistently remains refractory to appropriate medical therapy (e.g., topical antifungals, corticosteroids, antibiotics) over a period of three months. 15

• Difficulty walking or functional impairment in activities of daily living. 15,16

• If the procedure is being performed following significant weight loss, in addition to meeting the criteria noted above, there should be evidence that the patient has maintained a stable weight for at least six months. For patients whose weight loss is the result of bariatric surgery, abdominal lipectomy/panniculectomy should not be performed until at least 18 months after bariatric surgery and only when weight has been stable for at least the most recent six months. 15

• Reconstructive Breast Surgery: Removal of Breast Implants

The removal of implant(s), whether placed for reconstructive or cosmetic purposes, will be considered medically reasonable and necessary for the treatment of any one or more of the following conditions 4 :

• Broken or failed implant

• Infection or inflammatory reaction due to breast prosthesis; including infected breast implant, or rejection of breast implants.

• Implant extrusion

• Siliconoma or granuloma

• Interference with diagnosis of breast cancer

• Painful capsular contracture with disfigurement

• Reduction Mammaplasty

Reduction mammaplasty will be considered medically reasonable and necessary when performed:

• To reduce the size of the breasts and help ameliorate symptoms caused by hypertrophy when:

• The surgeon's estimate of breast size/weight/volume to be removed is proportional to the body surface area (BSA) per the Schnur scale 5 per breast to relieve symptoms.

• There are signs or symptoms resulting from the enlarged breasts (macromastia) that have not responded adequately to non-surgical interventions.

• Symptoms are refractory to appropriately fitted supporting garments, or following unilateral mastectomy, persistent with an appropriately fitted prosthesis or reconstruction therapy at the site of the absent breast.

• Dermatologic signs or symptoms are refractory to or recurrent following a completed course of medical management.

• Intertriginous maceration, discoloration, chronic or recurrent infection of the inframammary skin refractory to dermatologic treatment measures.

• There is back pain from macromastia, unrelieved by:

• Conservative analgesia.

• Supportive measures (custom garment, etc.).

• Physical therapy.

• There is shoulder grooving to a depth greater than 1 cm with skin irritation or darkening by supporting garment (bra strap).

• There are optimally managed significant arthritic changes in the cervical or upper thoracic spine, with persistent symptoms or significant restriction of activity.

• The macromastia is not due to an active endocrine, pharmaceutical or metabolic process.

OR

• To reduce the size of a normal breast to bring it into symmetry with a breast reconstructed after cancer surgery. Note: either the involved breast or contralateral breast may be treated to achieve symmetry.

• Mastectomy for Gynecomastia

Medicare considers reduction mammaplasty reconstructive for gynecomastia. Mastectomy with nipple preservation or reduction mammoplasty is considered reconstructive and medically reasonable and necessary:

• For males with unilateral or bilateral gynecomastia Grade III and IV as defined on the ASPS gynecomastia scale or abnormal breast development with redundancy.

• Persists more than 3 to 4 months after pathological causes are ruled out.

• Persists after 3 to 4 months of unsuccessful medical treatment for pathological gynecomastia. 10

• Pain or tenderness directly related to the breast tissue which has a clinically significant impact upon activities of daily living.

• Clinical symptoms refractory to a trial of analgesics or anti-inflammatory agents.

• For significant clinical manifestations when the excessive breast weight adversely affects the supporting structures of the shoulders, neck, and trunk.

• Gigantomastia of Pregnancy

Medicare considers subtotal mastectomy or reduction mammaplasty for the unusual condition of Gigantomastia of Pregnancy accompanied by any of the following complications (and delivery is not imminent) medically reasonable and necessary for the following situations when signs or symptoms are refractory to medical treatment or physical interventions have not adequately alleviated symptoms such as:

• Massive infection;

• Significant hemorrhage;

• Tissue necrosis with slough;

The American Society of Plastic Surgeons explained plastic surgery may be reconstructive or cosmetic procedures. 1 Usually, reconstructive surgery is considered medically necessary to correct deformities created by congenital defects, trauma, or medical conditions. Cosmetic surgery is used to reshape or adjust parts of the anatomy to enhance the visual appearance and is usually considered not medically necessary. There are instances where these two subspecialties of plastic surgery overlap as there are certain conditions that can be deemed either reconstructive or cosmetic in nature. Rhinoplasty surgery is a good example as this procedure is usually performed to improve the appearance of the nose but the procedure may also be medically necessary to improve nasal breathing or restore a normal appearance after a traumatic injury such as a nasal fracture.

Dermabrasion

Chellappan and Castro 13 performed a case report to support the use of electrocautery and dermabrasion as the mainstay of treatment for severe rhinophyma. Rhinophyma is classified as stage IV rosacea which is the most advanced stage. It is characterized by phymatous changes which presents with hypertrophic thickening with edema of the nasal pyramid skin. Treatment for this condition should begin in the early stages to prevent progression into the more advanced stages with irreversible fibrotic changes. Extensive thickening of the tissue can obstruct external nasal valves making treatment of the rhinophyma medically necessary to alleviate respiratory issues. The patient in this case report had a history of acne rosacea which progressed into severe rhinophyma causing major deformity and nasal obstruction. Electrocautery and dermabrasion were performed to remove hypertrophic skin and create a smooth contour which resulted in a substantial improvement in respiratory function. The patient’s skin returned to normal pigmentation and was scab-free four weeks after the procedure. This case report supports electrocautery dermabrasion as the mainstay of treatment which allows for smooth contouring, efficient hemostasis, and does not require multiple procedures.

Torresetti et al 14 performed a case report and review of literature regarding treatment of disfiguring rhinophyma. Medical treatments such as antibiotics and retinoids are useful in the early stages in hopes of suppressing sebum secretion and treating any associated infections. The general consensus for treatment of rhinophyma remains the surgical removal of the thickened tissue either by full thickness excision or partial thickness excision. Partial thickness excision has been largely performed by many different procedures including dermabrasion. In the cases of infiltrating rhinophyma, such as rhinophyma with underlying skin cancer, total eradication is considered and usually requires flap coverage or skin grafts.