Bilateral Gynecomastia

Bilateral gynecomastia is a benign enlargement of the male breast, either due to increased adipose tissue, glandular tissue, fibrous tissue, or a combination of all three. Bilateral gynecomastia may be associated with any of the following:

·         An underlying hormonal disorder (ie, conditions causing either estrogen excess or testosterone deficiency such as liver disease or an endocrine disorder)

·         An adverse effect of certain drugs

·         Obesity

·         Related to specific age groups, ie,

o    Neonatal gynecomastia, related to action of maternal or placental estrogens

o    Adolescent gynecomastia, which consists of transient, bilateral breast enlargement, which may be tender

o    Gynecomastia of aging, related to the decreasing levels of testosterone and relative estrogen excess.

Removal of the breast tissue is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration.

Related Policies

• None

FIDE SNP: For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

[RATIONALE: This policy was created in 1995 and has been updated regularly with searches of the MEDLINE database. The most recent literature update was performedthrough December 6, 2018.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function¾including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Bilateral Gynecomastia

Clinical Context and Therapy Purpose

The purpose of surgical therapy for bilateral gynecomastia is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as conservative treatment.

The question addressed in this policy is: is the net health outcome of individuals with bilateral gynecomastia improved by surgical treatment?

The following PICOTS were used to select literature to inform this review.

Patients

The relevant population of interest is individuals with bilateral gynecomastia, a benign enlargement of the male breast due either to increased adipose, glandular, or fibrous tissue or a combination of the three. An underlying hormonal disorder, obesity, and an adverse effect of certain drugs may be associated with the condition. Additionally, the bilateral gynecomastia may be related to specific age groups, including neonates, adolescents, and in aging men with decreasing levels of testosterone and relative estrogen excess.

Interventions

The therapy being considered is surgical treatment: removal of the breast tissue by surgical excision or liposuction.

Comparators

The main comparators of interest is conservative treatment, which varies based on the underlying cause of the condition and can include treatment of underlying hormonal disorder, cessation of drug therapy, and weight loss.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, health status measures, quality of life, and treatment-related morbidity. Symptoms of bilateral gynecomastia may include enlargement, tenderness, and lumps in the breast tissue.

Timing

Evaluation of the general outcomes of interest requires a long follow-up period beyond the immediate postoperative period if surgery is performed. In the existing literature evaluating surgery as a treatment for bilateral gynecomastia, follow-up is 5 years.

Setting

Patients with bilateral gynecomastia are managed by plastic surgeons in an outpatient setting.

Study Selection Criteria

Methodologically credible studies were selected using the following principles: 

a.     To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

b.     In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

c.     To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

d.     Studies with duplicative or overlapping populations were excluded.

Coverage eligibility for treatment of bilateral gynecomastia is largely a contract/benefits issue related to the distinction between cosmetic and reconstructive services. The surgical procedure may involve surgical excision (ie, mastectomy). More recently, liposuction has been used.^1,2 In some instances, adolescent gynecomastia may be reported as tender or painful, and the presence of these symptoms may be presented as a basis for surgical treatment. However, the pain associated with adolescent gynecomastia is typically self-limiting or responds to analgesic therapy.

No randomized clinical trials were identified to assess various surgical interventions to treat male gynecomastia.

Nonrandomized Studies

Exposure of new techniques, quality of life assessments and other nonsurgical outcomes have been reported in the literature.

Abdelrahman (2018) published a retrospective analysis of 18 patients with grade I-II gynecomastia treated with a combination of traditional liposuction and glandular liposculpturing between 2014 and 2016.⁵  Outcomes assessed included treatment-related morbidity and adverse events and patient reported outcomes (PROs)  The PROs included patient satisfaction using the Breast Evaluation Questionaire (BEQ). Other notable information gained include treatment-related morbidity and adverse events. The post-operative aesthetic appearance was evaluated by 5 independent plastic surgeons (“observers”) who were blinded to the surgery performed making their assessments based on preoperative and 6 month postoperative photographs. The observers concluded that an acceptable post-operative result was achieved (92% of the ratings); 8% of the ratings suggested subsequent liposuction needed to be performed. The level of agreement was assessed and statistically significant for varying aesthetic variables (eg, nipple projection, p=.005). Treatment-related morbidities or adverse events were minimal and include wound infection (1/18, 5.56%) and complaints of breast-tissue remnants and requests for subsequent operation (2/18, 11.1%).

Nuzzi et al (2018) published a longitudinal cohort study aimed at measuring changes in health-related quality of life following surgical management of gynecomastia in adolescents using 3 surveys administered over a 5-year period to both the intervention group and age- and sex-matched controls.⁶ The surveys administered were the Short-form 36v2 (SF-36), Rosenberg Self-Esteem Scale (RSES), and Eating-Attitudes Test-26. From 2008 to 2017, 44 patients who underwent treatment of gynecomastia and 64 unaffected controls who participated in the study. Patients in the intervention group scored significantly poorer at baseline compared with controls on both the RSES and EAT-26 (p<.05, both), even after controlling for BMI differences. Gynecomastia patients scored lower on five SF-36 domains than the controls: general health, vitality, social functioning, role-emotional, and mental health (p<.05, all). Scores significantly improved post-operatively on the RSES and in four SF-36 domains. Post-operatively, gynecomastia patients scored similarly to the control group on the SF-36 and RSES, indicating an improvement in quality of life.

Table 1. Summary of Nonrandomized Studies Characteristics

Study	Study Type	Country	Dates	Participants	Treatment1	Treatment2	Follow-Up
Abdelrahman (2018)5	Retrospective analysis	Egypt	2014-2016	Individuals with grade I or II gynecomastia (n=18)	Traditional liposuction and glandular liposculpturing		6-months
Nuzzi (2010)6	Prospective, longitudinal cohort study	US	2008-2017	Adolescents diagnosed with unilateral of bilateral gynecomastia (n=44) and male controls (n=64)	Surgical intervention	Control	5-years

Table 2. Summary of Observational Comparative Study Results

Study	Mean pre-operative BEQ	Mean post-operative BEQ	Patients’ mean overall satisfaction score (SD)	Morbidities1	Morbidities2
Abdelrahman (2018)5
Study group	2.1 (0.2)	4.1 (0.2)	4.7 (0.7)	Wound infection (1/18, 5.56%)	Complaints of breast tissue remnant and requests for subsequent operation (2/18; 11.1%)
p-value	.001	.001
	SF-36 – Physical Functioning (SD)	SF-36 – Bodily Pain (SD)	SF-36 – General Health (SD)	SF-36 – Social Functioning (SD)	RSES (SD)	EAT-26 (SD)
Nuzzi (2018)6
Treatment group	97.0 (7.2)	81.2 (11.0)	77.4 (17.8)	84.6 (22.0)	32.5 (6.4)	8.0 (6.5)
Control	97.1 (11.6)	78.7 (15.3)	83.6 (16.0)	88.3 (20.6)	34.8 (5.8)	3.8 (5.2)
p-value	.78	.59	.59	.42	.26	.001

BEQ= Breast evaluation questionnaire; EAT-26 = eating-attitudes test-26; RSES = Rosenberg self-esteem scale; SF-36 = short-form 36v2; CI = confidence interval

Section Summary: Bilateral Gynecomastia

To demonstrate improvement in health outcomes, controlled trials are needed that report clinically important outcomes such as improvement in functional status. No such trials were identified through a literature search. A systematic review published in 2015 included 14 studies on the treatment of gynecomastia.^3, None were randomized, all were judged to be at high risk of bias, and the body of evidence was determined to be of very low quality by GRADE criteria. The literature addresses itself to quality of life patient reported outcomes with a focus on adolescents.

Summary of Evidence

For individuals with bilateral gynecomastia who receive surgical treatment, the evidence includes case series. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related morbidity. Because there are no randomized controlled trials on surgical treatment of bilateral gynecomastia, it is not possible to determine with a high level of confidence whether surgical treatment improves symptoms or functional impairment. Conservative therapy should adequately address any physical pain or discomfort, and gynecomastia does not typically cause functional impairment. The evidence is insufficient to determine the effect of the technology on net health outcomes.

SUPPLEMENTAL INFORMATION

Practice Guidelines and Position Statements

The American Society of Plastic Surgeons (ASPS) issued practice criteria for third-party payers in 2002, which was affirmed in 2015.^4, ASPS classified gynecomastia using the following scale, which was “adapted from the McKinney and Simon, Hoffman and Kohn scales”:

·         “Grade I: Small breast enlargement with localized button of tissue that is concentrated around the areola.

·         “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.”

According to ASPS, in adolescents, surgical treatment for “[u]nilateral or bilateral grade II or III gynecomastia” may be appropriate if the gynecomastia “persists for more than 1 year after pathological causation is ruled out” (or 6 months if grade IV) and continues “after 6 months of unsuccessful medical treatment for pathological gynecomastia.” In adults, surgical treatment for “[u]nilateral or bilateral grade III or IV gynecomastia” may be appropriate if the gynecomastia “persists for more than 3 or 4 months after pathological causes ruled out [and continues] after 3 or 4 months of unsuccessful medical treatment for pathological gynecomastia.” ASPS also indicated that surgical treatment of gynecomastia maybe appropriate when distention and tightness cause “pain and discomfort.”

U.S. Preventive Services Task Force Recommendations

Not applicable.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in December 2018 did not identify any ongoing or unpublished trials that would likely influence this review.]
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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Mastectomy for Gynecomastia
Gynecomastia, Mastectomy for

References:
1. Rohrich RJ, Ha RY, Kenkel JM, et al. Classification and management of gynecomastia: defining the role of ultrasound-assisted liposuction. Plast Reconstr Surg. Feb 2003;111(2):909-923; discussion 924-925. PMID 12560721

2. Goes JC, Landecker A. Ultrasound-assisted lipoplasty (UAL) in breast surgery. Aesthetic Plast Surg. Jan-Feb 2002;26(1):1-9. PMID 11891589

3. Fagerlund A, Lewin R, Rufolo G, et al. Gynecomastia: A systematic review. J Plast Surg Hand Surg. Dec 2015;49(6):311-318. PMID 26051284

4. American Society of Plastic Surgeons. ASPS Recommended Insurance Coverage Criteria for Third-Party Payers: Gynecomastia. 2002 (affirmed 2015); https://www.plasticsurgery.org/Documents/Health-Policy/Positions/Gynecomastia_ICC.pdf. Accessed January 9, 2018.

5. Abdelrahman I, Steinvall I, Mossaad B, et al. Evaluation of Glandular Liposculpture as a Single Treatment for Grades I and II Gynaecomastia. Aesthetic Plast Surg. Oct 2018;42(5):1222-1230. PMID 29549405

6. Nuzzi LC, Firriolo JM, Pike CM, et al. The Effect of Surgical Treatment for Gynecomastia on Quality of Life in Adolescents. J Adolesc Health. Dec 2018;63(6):759-765. PMID 30279103

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

19300