Cigna Gynecomastia Surgery - (0195) Form

The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients.

Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer's particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer's benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer's benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document.

Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Each coverage request should be reviewed on its own merits. Medical directors are expected to exercise clinical judgment and have discretion in making individual coverage determinations.

Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations.

Medical Coverage Policy: 0195

Coverage Policy Coverage for the surgical treatment of gynecomastia varies across plans. Refer to the customer's benefit plan document for coverage details.

Mastectomy or reduction mammoplasty for the surgical treatment of gynecomastia is considered medically necessary for EITHER of the following conditions:

• Klinefelter syndrome
• Either pubertal (adolescent) onset gynecomastia that has persisted for at least two years OR post pubertal-onset gynecomastia that has persisted for one year, when ALL of the following criteria are met:
  • Glandular breast tissue confirming true gynecomastia is documented on physical exam and/or mammography.
  • The gynecomastia is classified as Grade II, III or IV per the American Society of Plastic Surgeons classification.
  • Preoperative frontal and lateral photographs confirm the presence of at least Grade II gynecomastia.
  • The condition is associated with persistent breast pain, despite the use of analgesics.
  • The use of potential gynecomastia-inducing drugs and substances has been identified and discontinued for at least one year, when medically appropriate.
  • The gynecomastia persists, despite correction of any underlying causes.
  • Hormonal causes, including hyperthyroidism, estrogen excess, hyperprolactinemia and hypogonadism have been excluded by appropriate laboratory testing (e.g., with levels of thyroid stimulating hormone [TSH], estradiol, prolactin, testosterone and/or luteinizing hormone [LH]) and, if present, have been treated for at least 12 months before surgery has been considered.

Mastectomy or reduction mammoplasty for the surgical treatment of gynecomastia for ANY other indication is considered not medically necessary.

Mastectomy or reduction mammoplasty for the surgical treatment of gynecomastia for EITHER of the following indications is considered cosmetic in nature and not medically necessary:

• when performed solely to improve appearance of the male breast or to alter contours of the chest wall
• when performed solely to treat psychological or psychosocial complaints

Liposuction or ultrasonically-assisted liposuction (suction lipectomy) as a sole method of treatment for gynecomastia is considered experimental, investigational, or unproven. Liposuction or ultrasonically-assisted liposuction (suction lipectomy) used in conjunction with reduction mammoplasty or mastectomy for the treatment of gynecomastia is considered integral to the primary procedure and will not be separately reimbursed.

Medical Coverage Policy: 0195

General Background

Gynecomastia is the benign proliferation of glandular breast tissue in males. It differs from proliferation of breast tissue in females in that there is no terminal alveolar development in response to progesterone. Gynecomastia is characterized by a mass or ridge of glandular tissue that is symmetrically distributed around the areolar-nipple complex. It can generally be detected when the glandular tissue is greater than 0.5 cm (0.2 inches) in diameter. Gynecomastia may be tender to palpation early in the course. It is usually bilateral, but some patients present with unilateral enlargement or bilateral enlargement with one side larger than the other or enlarging weeks to months before the other.

The distinct mass of glandular tissue, central location, and symmetrical shape distinguish gynecomastia from other causes of male breast enlargement in children and adolescents. In children and adolescents, gynecomastia is common during the neonatal period and during puberty. Gynecomastia is uncommon in pre-pubertal boys. Pathologic gynecomastia is rare in children and adolescents but may be associated with substantial morbidity (e.g., testicular, adrenal, or pituitary tumors). Pathologic gynecomastia usually is associated with other abnormalities on physical examination or clinical features that are not characteristic of physiologic gynecomastia.

The majority of cases of gynecomastia in children and adolescents are physiologic. Neonatal gynecomastia is physiologic and presumably related to placental transformation of androgens to estrogens, which enter the fetal circulation and stimulate glandular proliferation. It usually regresses spontaneously and completely within the first year of life. Pubertal gynecomastia is a physiologic enlargement of the glandular breast tissue that occurs in some boys during puberty. Adolescents with pubertal gynecomastia usually complain of a mass or lump behind the nipple. The breast may be tender for approximately six months after onset, but tenderness gradually resolves as the glandular tissue undergoes fibrosis and the inflammatory reaction and stretching of tissues diminish. Pubertal gynecomastia regresses substantially or resolves in greater than 70 percent of patients after one year if left untreated. Gynecomastia that persists for 1 year or greater or after age 17 years generally does not spontaneously regress.

Primary (hypergonadotropic) hypogonadism accounts for approximately eight percent and secondary (hypogonadotropic) hypogonadism accounts for approximately two percent of cases of gynecomastia in adult patients seeking consultation for gynecomastia. Klinefelter syndrome, polysomy X, is the most common congenital cause of primary hypogonadism and often presents during adolescence.

Klinefelter syndrome (XXY) is associated with a 50-fold increase in male breast cancer incidence compared to XY males. As many as 70 percent of patients with Klinefelter syndrome have gynecomastia, which usually is slowly progressive (Taylor/UpToDate, 2022; Ionescu, et al., 2022). A careful breast examination is the first step to distinguishing true gynecomastia (enlargement of the glandular tissue) from pseudogynecomastia (excessive adipose tissue). In mixed gynecomastia, the breast enlargement is due to both glandular and adipose tissue. The physician can at times determine the differences through physical examination of the breast. Mammography and ultrasound can also be used to separate true gynecomastia from pseudogynecomastia. Therefore, diagnosis of true gynecomastia should be documented through physical examination and/or mammography. The American Society of Plastic Surgeons (ASPS, 2015) recommends using a scale adapted from the McKinney and Simon, Hoffman and Khan scales to characterize the severity of gynecomastia:

Medical Coverage Policy: 0195

• 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 distinct from the chest with skin redundancy present
• Grade IV Marked breast enlargement with skin redundancy and feminization of the breast

Hormone testing may be necessary to determine the cause of the condition and may include thyroid stimulating hormone (TSH), estradiol, prolactin, testosterone and/or luteinizing hormone (LH). Treating the primary cause of gynecomastia involves the identification of a causative agent and discontinuation of its use when medically appropriate, which will often result in resolution of the condition. Treatment essentially consists of correction of the underlying disorder, removal of the causative drug (if applicable) and, in some cases, the additional use of pharmaceutical agents to treat the condition and/or its symptoms. These agents include antiestrogens, aromatase inhibitors and danazol (androgen) to inhibit gonadotropin secretion. In the absence of resolution, further medical or surgical treatment may be considered.

Conditions of gynecomastia that persist for longer than one year are less likely to be reversed by medical management because of increased stromal hyalinization, dilatation of the ducts and a marked reduction in proliferation. Medical therapies have been found most effective in the proliferative phase of gynecomastia. In most cases, once inactive fibrotic tissue develops, medical intervention is less successful. Surgical treatment involves removing the glandular breast tissue and is generally reserved for patients who demonstrate irreversible fibrotic changes, continued growth and pain. Procedures commonly used in the treatment of gynecomastia include mastectomy, subtotal mastectomy, subcutaneous mastectomy and reduction mammoplasty.

Literature Review

Holzmer et al. (2020) conducted a review of the current literature and evaluated 17 studies. Key data points included gynecomastia grade, surgical intervention, rate of complication, including hematoma, seroma, infection, and necrosis, and drain use. A total of 1112 patients underwent surgical treatment for gynecomastia. Skin-sparing mastectomy with or without liposuction was the most frequently used procedure followed by mastectomy with skin reduction. Major complication rates ranged from 0% to 33%, with hematoma formation being most common (5.8%) followed by seroma (2.4%).

There was a higher rate of hematoma/seroma formation among authors who routinely utilized drain placement (9.78% versus 8.36%; p = 0.0051); however, this is likely attributable to the large discrepancy in percentage of grade III patients found in each group (50.23% versus 4.36%; p = 0.0000).

The authors noted a wide variety of surgical techniques exist for the treatment of gynecomastia. Suction-assisted lipectomy (liposuction) has been performed as an adjunct surgical procedure in some cases, although its use is limited in cases that are severe or in breasts that are fibrous. When liposuction is performed as a sole method of treatment for gynecomastia, only adipose tissue is removed. Liposuction reduces the overall breast size and may result in improved appearance, but it does not remove the glandular tissue and, therefore, does not correct the gynecomastia.

Ultrasound-assisted suction lipectomy is a proposed method of treatment for gynecomastia. Proponents contend it improves the removal of dense, fibrous male breast tissueMedical Coverage Policy: 0195 and offers minimal external scarring (Esme, et al., 2007; Hodgson, et al., 2005; Rohrich, et al., 2003). These methods of treatment, however, are not well-supported in the peer-reviewed, published, scientific literature and are not considered an acceptable alternative to standard surgical approaches for the removal of glandular tissue for the treatment of true gynecomastia.

Innocenti et al. (2022) conducted a systematic review of the literature to assess the incidence of complications with all proposed techniques and for combined procedures versus single approach procedures in gynecomastia correction. A total number of 94 articles was obtained for 7294 patients analyzed. Patients were divided into three groups: aspiration techniques, consisting in 874 patients (11, 98%), surgical excision techniques, consisting in 2764 patients (37, 90%), and combined techniques, consisting in 3656 patients (50,12%). The authors concluded that the combined use of surgical excision and aspiration techniques seems to reduce the rate of complications compared to surgical excision alone, but the lack of unique classification and the presence of several surgical techniques still represents a bias in the literature review.

Professional Societies/Organizations

American Society of Plastic Surgeons (ASPS): The ASPS has developed a series of papers outlining the Society's position on recommended insurance Coverage Criteria for third-party payer coverage. Gynecomastia (June 2015) Coverage Criteria states that the surgical treatment of gynecomastia has two objectives: reconstruction of the male chest contour, and histological clarification of suspicious breast lesions. The age of the patient, consistency, grade, and the presence of unilateral or bilateral breast development determine the indication for surgery. It includes recommended insurance coverage criteria for adolescents and adults.

Use Outside of the US

European Academy of Andrology (EAA) Clinical Practice Guidelines on Gynecomastia Evaluation and Management (Kanakis, et al., 2019) suggest surgical treatment only for patients with long-lasting gynecomastia, which does not regress spontaneously or following medical therapy. The extent and type of surgery depend on the size of breast enlargement, and the amount of adipose tissue.