Gender Reassignment Surgery

Number: 0615

Policy

Aetna considers gender reassignment surgery medically necessary when all of the following criteria are met:

1. Requirements for mastectomy for female-to-male patients:

   1. Single letter of referral from a qualified mental health professional (see Appendix); and
   2. Persistent, well-documented gender dysphoria (see Appendix); and
   3. Capacity to make a fully informed decision and to consent for treatment; and
   4. For members below the age of majority (less than 18 years of age), completion of one year of testosterone treatment; and
   5. If significant medical or mental health concerns are present, they must be reasonably well controlled.

   Note that a trial of hormone therapy is not a pre-requisite to qualifying for a mastectomy in adults.

2. Requirements for gonadectomy (hysterectomy and oophorectomy in female-to-male and orchiectomy in male-to-female):

   1. Two referral letters from qualified mental health professionals, one in a purely evaluative role (see appendix); and
   2. Persistent, well-documented gender dysphoria (see Appendix); and
   3. Capacity to make a fully informed decision and to consent for treatment; and
   4. Age of majority (18 years or older); and
   5. If significant medical or mental health concerns are present, they must be reasonably well controlled; and
   6. Twelve months of continuous hormone therapy as appropriate to the member's gender goals (unless the member has a medical contraindication or is otherwise unable or unwilling to take hormones)

3. Requirements for genital reconstructive surgery (i.e., vaginectomy, urethroplasty, metoidioplasty, phalloplasty, scrotoplasty, and placement of a testicular prosthesis and erectile prosthesis in female to male; penectomy, vaginoplasty, labiaplasty, and clitoroplasty in male to female)

   1. Two referral letters from qualified mental health professionals, one in a purely evaluative role (see appendix); and
   2. Persistent, well-documented gender dysphoria (see Appendix); and
   3. Capacity to make a fully informed decision and to consent for treatment; and
   4. Age of majority (age 18 years and older); and
   5. If significant medical or mental health concerns are present, they must be reasonably well controlled; and
   6. Twelve months of continuous hormone therapy as appropriate to the member’s gender goals (unless the member has a medical contraindication or is otherwise unable or unwilling to take hormones); and
   7. Twelve months of living in a gender role that is congruent with their gender identity (real life experience).

Note: Blepharoplasty, body contouring (liposuction of the waist), breast enlargement procedures such as augmentation mammoplasty and implants, face-lifting, facial bone reduction, feminization of torso, hair removal, lip enhancement, reduction thyroid chondroplasty, rhinoplasty, skin resurfacing (dermabrasion, chemical peel), and voice modification surgery (laryngoplasty, cricothyroid approximation or shortening of the vocal cords), which have been used in feminization, are considered cosmetic. Similarly, chin implants, lip reduction, masculinization of torso, and nose implants, which have been used to assist masculinization, are considered cosmetic.

Note on gender specific services for the transgender community

Gender-specific services may be medically necessary for transgender persons appropriate to their anatomy.  Examples include:

1. Breast cancer screening may be medically necessary for female to male trans identified persons who have not undergone a mastectomy;
2. Prostate cancer screening may be medically necessary for male to female trans identified persons who have retained their prostate.

Aetna considers gonadotropin-releasing hormone medically necessary to suppress puberty in trans identified adolescents if they meet World Professional Association for Transgender Health (WPATH) criteria (see CPB 0501 - Gonadotropin-Releasing Hormone Analogs and Antagonists).

Aetna considers the following procedures that may be performed as a component of a gender reassignment as cosmetic (not an all-inclusive list) (see also CPB 0031 - Cosmetic Surgery):

• Abdominoplasty
• Blepharoplasty
• Brow lift
• Calf implants
• Cheek/malar implants
• Chin/nose implants
• Collagen injections
• Construction of a clitoral hood
• Drugs for hair loss or growth
• Forehead lift
• Jaw reduction (jaw contouring)
• Hair removal (e.g., electrolysis, laser hair removal) 
• Hair transplantation
• Lip reduction
• Liposuction
• Mastopexy
• Neck tightening
• Nipple reconstruction
• Nose implants
• Pectoral implants
• Pitch-raising surgery
• Removal of redundant skin
• Rhinoplasty
• Voice therapy/voice lessons.

Background

Gender dysphoria refers to discomfort or distress that is caused by a discrepancy between an individual’s gender identity and the gender assigned at birth (and the associated gender role and/or primary and secondary sex characteristics). A diagnosis of gender dysphoria requires a marked difference between the individual’s expressed/experienced gender and the gender others would assign him or her, and it must continue for at least six months. This condition may cause clinically significant distress or impairment in social, occupational or other important areas of functioning.  

Gender reassignment surgery is performed to change primary and/or secondary sex characteristics. For male to female gender reassignment, surgical procedures may include genital reconstruction (vaginoplasty, penectomy, orchidectomy, clitoroplasty) and cosmetic surgery (breast implants, facial reshaping, rhinoplasty, abdominoplasty, thyroid chondroplasty (laryngeal shaving), voice modification surgery (vocal cord shortening), hair transplants) (Day, 2002). For female to male gender reassignment, surgical procedures may include mastectomy, genital reconstruction (phalloplasty, genitoplasty, hysterectomy, bilateral oophorectomy), mastectomy, and cosmetic procedures to enhance male features such as pectoral implants and chest wall recontouring (Day, 2002).

The criterion noted above for some types of genital surgeries – i.e., that patients engage in 12 continuous months of living in a gender role that is congruent with their gender identity – is based on expert clinical consensus that this experience provides ample opportunity for patients to experience and socially adjust in their desired gender role, before undergoing irreversible surgery (Coleman, et al., 2011). 

In addition to hormone therapy and gender reassignment surgery, psychological adjustments are necessary in affirming sex. Treatment should focus on psychological adjustment, with hormone therapy and gender reassignment surgery being viewed as confirmatory procedures dependent on adequate psychological adjustment. Mental health care may need to be continued after gender reassignment surgery. The overall success of treatment depends partly on the technical success of the surgery, but more crucially on the psychological adjustment of the trans identified person and the support from family, friends, employers and the medical profession.

Nakatsuka (2012) noted that the 3rd versions of the guideline for treatment of people with gender dysphoria (GD) of the Japanese Society of Psychiatry and Neurology recommends that feminizing/masculinizing hormone therapy and genital surgery should not be carried out until 18 years old and 20 years old, respectively.  On the other hand, the 6th (2001) and the 7th (2011) versions of the standards of care for the health of transsexual, transgender, and gender non-conforming people of World Professional Association for Transgender Health (WPATH) recommend that transgender adolescents (Tanner stage 2, [mainly 12 to 13 years of age]) are treated by the endocrinologists to suppress puberty with gonadotropin-releasing hormone (GnRH) agonists until age 16 years old, after which cross-sex hormones may be given.  A questionnaire on 181 people with GID diagnosed in the Okayama University Hospital (Japan) showed that female to male (FTM) trans identified individuals hoped to begin masculinizing hormone therapy at age of 15.6 +/- 4.0 (mean +/- S.D.) whereas male to female (MTF) trans identified individuals hoped to begin feminizing hormone therapy as early as age 12.5 +/- 4.0, before presenting secondary sex characters.  After confirmation of strong and persistent trans gender identification, adolescents with GD should be treated with cross-gender hormone or puberty-delaying hormone to prevent developing undesired sex characters.  These treatments may prevent transgender adolescents from attempting suicide, suffering from depression, and refusing to attend school. 

Spack (2013) stated that GD is poorly understood from both mechanistic and clinical standpoints.  Awareness of the condition appears to be increasing, probably because of greater societal acceptance and available hormonal treatment.  Therapeutic options include hormone and surgical treatments but may be limited by insurance coverage because costs are high.  For patients seeking MTF affirmation, hormone treatment includes estrogens, finasteride, spironolactone, and GnRH analogs.  Surgical options include feminizing genital and facial surgery, breast augmentation, and various fat transplantations.  For patients seeking a FTM gender affirmation, medical therapy includes testosterone and GnRH analogs and surgical therapy includes mammoplasty and phalloplasty.  Medical therapy for both FTM and MTF can be started in early puberty, although long-term effects are not known.  All patients considering treatment need counseling and medical monitoring.

Leinung and colleagues (2013) noted that the Endocrine Society's recently published clinical practice guidelines for the treatment of transgender persons acknowledged the need for further information on transgender health.  These investigators reported the experience of one provider with the endocrine treatment of transgender persons over the past 2 decades. Data on demographics, clinical response to treatment, and psychosocial status were collected on all transgender persons receiving cross-sex hormone therapy since 1991 at the endocrinology clinic at Albany Medical Center, a tertiary care referral center serving upstate New York.  Through 2009, a total 192 MTF and 50 FTM transgender persons were seen.  These patients had a high prevalence of mental health and psychiatric problems (over 50 %), with low rates of employment and high levels of disability.  Mental health and psychiatric problems were inversely correlated with age at presentation.  The prevalence of gender reassignment surgery was low (31 % for MTF).  The number of persons seeking treatment has increased substantially in recent years.  Cross-sex hormone therapy achieves very good results in FTM persons and is most successful in MTF persons when initiated at younger ages.  The authors concluded that transgender persons seeking hormonal therapy are being seen with increasing frequency.  The dysphoria present in many transgender persons is associated with significant mood disorders that interfere with successful careers.  They stated that starting therapy at an earlier age may lessen the negative impact on mental health and lead to improved social outcomes.

Meyer-Bahlburg (2013) summarized for the practicing endocrinologist the current literature on the psychobiology of the development of gender identity and its variants in individuals with disorders of sex development or with transgenderism.  Gender reassignment remains the treatment of choice for strong and persistent gender dysphoria in both categories, but more research is needed on the short-term and long-term effects of puberty-suppressing medications and cross-sex hormones on brain and behavior.

Irreversible Surgical Interventions for Minors

The World Professional Association for Transgender Health (WPATH) recommendations version 7 (Coleman, et al., 2011) states, regarding irreversible surgical interventions, that "[g]enital surgery should not be carried out until (i) patients reach the legal age of majority in a given country, and (ii) patients have lived continuously for at least 12 months in the gender role that is congruent with their gender identity. The age threshold should be seen as a minimum criterion and not an indication in and of itself for active intervention." The WPATH guidelines state that "Chest surgery in FtM patients could be carried out earlier, preferably after ample time of living in the desired gender role and after one year of testosterone treatment. The intent of this suggested sequence is to give adolescents sufficient opportunity to experience and socially adjust in a more masculine gender role, before undergoing irreversible surgery. However, different approaches may be more suitable, depending on an adolescent’s specific clinical situation and goals for gender identity expression.”

Note on Nipple Reconstruction

Aetna considers nipple reconstruction, as defined by the American Medical Association (AMA) Current Procedural Terminology (CPT) code 19350, cosmetic/not medically necessary for mastectomy for female to male gender reassignment. Performance of a mastectomy for gender reassignment does not involve a nipple reconstruction as defined by CPT code 19350. 

Some have cited breast reconstruction surgery for breast cancer, i.e., recreation of a breast after mastectomy, as support for coverage of nipple reconstruction. Mastectomy for female to male gender reassignment surgery, however, involves mastectomy without restoration of the breast. There are important differences between a mastectomy for breast cancer and a mastectomy for gender reassignment. The former requires careful attention to removal of all breast tissue to reduce the risk of cancer. By contrast, careful removal of all breast tissue is not essential in mastectomy for gender reassignment. 

In mastectomy for gender reassignment, the nipple areola complex typically can be preserved. There is no routine indication for nipple reconstruction as defined by CPT code 19350, the exceptions being unusual cases where construction of a new nipple may be necessary in persons with very large and ptotic breasts. See, e.g., Bowman, et al., 2006). 

Some have justified routinely billing CPT code 19350 for nipple reconstruction code for mastectomy for gender reassignment based upon the frequent need to reduce the size of the areola to give it a male appearance. However, the nipple reconstruction as defined by CPT code 19350 describes a much more involved procedure than areola reduction. The typical patient vignette for CPT code 19350, according to the AMA, is as follows: “The patient is measured in the standing position to ensure even balanced position for a location of the nipple and areola graft on the right breast.  Under local anesthesia, a Skate flap is elevated at the site selected for the nipple reconstruction and constructed.  A full-thickness skin graft is taken from the right groin to reconstruct the areola.  The right groin donor site is closed primarily in layers.”  

Aetna will consider allowing modifier -22 to be appended to the mastectomy CPT code when this procedure is performed for gender reassignment to allow additional reimbursement for the extra work that may be necessary to reshape the nipple and create an aesthetically pleasing male chest.  CPT code 19350 does not describe the work that that is being done, because that code describes the actual construction of a new nipple. The CPT defines modifier 22 as "Increased Procedural Services: When the work required to provide a service is substantially greater than typically required, it may be identified by adding modifier 22 to the usual procedure code. Documentation must support the substantial additional work and the reason for the additional work (i.e., increased intensity, time, technical difficulty of procedure, severity of patient's condition, physical and mental effort required)." 

Thus, Aetna considers nipple reconstruction, as defined by CPT code 19350, as cosmetic/not medically necessary for mastectomy for female to male gender reassignment, and that appending modifier 22 to the mastectomy code would more accurately reflect the extra work that may typically be necessary to obtain an aesthetically pleasing result.

Vulvoplasty versus Vaginoplasty as Gender-Affirming Genital Surgery for Transgender Women

Jiang and colleagues (2018) noted that gender-affirming vaginoplasty aims to create the external female genitalia (vulva) as well as the internal vaginal canal; however, not all patients desire nor can safely undergo vaginal canal creation.  These investigators described the factors influencing patient choice or surgeon recommendation of vulvoplasty (creation of the external appearance of female genitalia without creation of a neovaginal canal) and evaluated the patient's satisfaction with this choice.  Gender-affirming genital surgery consults were reviewed from March 2015 until December 2017, and patients scheduled for or who had completed vulvoplasty were interviewed by telephone.  These investigators reported demographic data and the reasons for choosing vulvoplasty as gender-affirming surgery for patients who either completed or were scheduled for surgery, in addition to patient reports of satisfaction with choice of surgery, satisfaction with the surgery itself, and sexual activity after surgery.  A total of 486 patients were seen in consultation for trans-feminine gender-affirming genital surgery: 396 requested vaginoplasty and 39 patients requested vulvoplasty; 30 Patients either completed or are scheduled for vulvoplasty.  Vulvoplasty patients were older and had higher body mass index (BMI) than those seeking vaginoplasty.  The majority (63 %) of the patients seeking vulvoplasty chose this surgery despite no contraindications to vaginoplasty.  The remaining patients had risk factors leading the surgeon to recommend vulvoplasty.  Of those who completed surgery, 93 % were satisfied with the surgery and their decision for vulvoplasty.  The authors concluded that this was the first study of factors impacting a patient's choice of or a surgeon's recommendation for vulvoplasty over vaginoplasty as gender-affirming genital surgery; it also was the first reported series of patients undergoing vulvoplasty only. 

Drawbacks of this study included its retrospective nature, non-validated questions, short-term follow-up, and selection bias in how vulvoplasty was offered.  Vulvoplasty is a form of gender-affirming feminizing surgery that does not involve creation of a neovagina, and it is associated with high satisfaction and low decision regret.

Autologous Fibroblast-Seeded Amnion for Reconstruction of Neo-vagina in Male-to-Female Reassignment Surgery

Seyed-Forootan and colleagues (2018) stated that plastic surgeons have used several methods for the construction of neo-vaginas, including the utilization of penile skin, free skin grafts, small bowel or recto-sigmoid grafts, an amnion graft, and cultured cells.  These researchers compared the results of amnion grafts with amnion seeded with autograft fibroblasts.  Over 8 years, these investigators compared the results of 24 male-to-female transsexual patients retrospectively based on their complications and levels of satisfaction; 16 patients in group A received amnion grafts with fibroblasts, and the patients in group B received only amnion grafts without any additional cellular lining.  The depths, sizes, secretions, and sensations of the vaginas were evaluated.  The patients were monitored for any complications, including over-secretion, stenosis, stricture, fistula formation, infection, and bleeding.  The mean age of group A was 28 ± 4 years and group B was 32 ± 3 years.  Patients were followed-up from 30 months to 8 years (mean of 36 ± 4) after surgery.  The depth of the vaginas for group A was 14 to 16 and 13 to 16 cm for group B.  There was no stenosis in neither group.  The diameter of the vaginal opening was 34 to 38 mm in group A and 33 to 38 cm in group B.  These researchers only had 2 cases of stricture in the neo-vagina in group B, but no stricture was recorded for group A.  All of the patients had good and acceptable sensation in the neo-vagina; 75 % of patients had sexual experience and of those, 93.7 % in group A and 87.5%  in group B expressed satisfaction.  The authors concluded that the creation of a neo-vaginal canal and its lining with allograft amnion and seeded autologous fibroblasts is an effective method for imitating a normal vagina.  The size of neo-vagina, secretion, sensation, and orgasm was good and proper.  More than 93.7 % of patients had satisfaction with sexual intercourse.  They stated that amnion seeded with fibroblasts extracted from the patient's own cells will result in a vagina with the proper size and moisture that can eliminate the need for long-term dilatation.  The constructed vagina has a 2-layer structure and is much more resistant to trauma and laceration.  No cases of stenosis or stricture were recorded.  Level of Evidence = IV.  These preliminary findings need to be validated by well-designed studies.

Pitch-Raising Surgery in Male-to-Female Transsexuals

Van Damme and colleagues (2017) reviewed the evidence of the effectiveness of pitch-raising surgery performed in male-to-female transsexuals.  These investigators carried out a search for studies in PubMed, Web of Science, Science Direct, EBSCOhost, Google Scholar, and the references in retrieved manuscripts, using as keywords "transsexual" or "transgender" combined with terms related to voice surgery.  They included 8 studies using cricothyroid approximation, 6 studies using anterior glottal web formation, and 6 studies using other surgery types or a combination of surgical techniques, leading to 20 studies in total.  Objectively, a substantial rise in post-operative fundamental frequency was identified.  Perceptually, mainly laryngeal web formation appeared risky for decreasing voice quality.  The majority of patients appeared satisfied with the outcome.  However, none of the studies used a control group and randomization process.  The authors concluded that future research needs to investigate long-term effects of pitch-raising surgery using a stronger study design. 

Azul and associates (2017) evaluated the currently available discursive and empirical data relating to those aspects of trans-masculine people's vocal situations that are not primarily gender-related, and identified restrictions to voice function that have been observed in this population, and made suggestions for future voice research and clinical practice.  These researchers conducted a comprehensive review of the voice literature.  Publications were identified by searching 6 electronic databases and bibliographies of relevant articles.  A total of 22 publications met inclusion criteria.  Discourses and empirical data were analyzed for factors and practices that impact on voice function and for indications of voice function-related problems in trans-masculine people.  The quality of the evidence was appraised.  The extent and quality of studies investigating trans-masculine people's voice function was found to be limited.  There was mixed evidence to suggest that trans-masculine people might experience restrictions to a range of domains of voice function, including vocal power, vocal control/stability, glottal function, pitch range/variability, vocal endurance, and voice quality.  The authors concluded that more research into the different factors and practices affecting trans-masculine people's voice function that took account of a range of parameters of voice function and considered participants' self-evaluations is needed to establish how functional voice production can be best supported in this population.

Appendix

DSM 5 Criteria for Gender Dysphoria in Adults and Adolescents

A. A marked incongruence between one’s experienced/expressed gender and assigned gender, of at least 6 months duration, as manifested by two or more of the following:

1. A marked incongruence between one’s experienced/expressed gender and primary and/or secondary sex characteristics (or, in young adolescents, the anticipated secondary sex characteristics)
2. A strong desire to be rid of one’s primary and/or secondary sex characteristics because of a marked incongruence with one’s experienced/expressed gender (or, in young adolescents, a desire to prevent the development of the anticipated secondary sex characteristics)
3. A strong desire for the primary and/or secondary sex characteristics of the other gender
4. A strong desire to be of the other gender (or some alternative gender different from one’s assigned gender)
5. A strong desire to be treated as the other gender (or some alternative gender different from one’s assigned gender)
6. A strong conviction that one has the typical feelings and reactions of the other gender (or some alternative gender different from one’s assigned gender)

B. The condition is associated with clinically significant distress or impairment in social, occupational, or other important areas of functioning.

Format for referral letters from Qualified Health Professional: (From SOC-7)

1. Client’s general identifying characteristics; and
2. Results of the client’s psychosocial assessment, including any diagnoses; and
3. The duration of the mental health professional’s relationship with the client, including the type of evaluation and therapy or counseling to date; and
4. An explanation that the WPATH criteria for surgery have been met, and a brief description of the clinical rationale for supporting the patient’s request for surgery; and
5. A statement about the fact that informed consent has been obtained from the patient; and
6. A statement that the mental health professional is available for coordination of care and welcomes a phone call to establish this.

Note:  There is no minimum duration of relationship required with mental health professional.  It is the professional’s judgment as to the appropriate length of time before a referral letter can appropriately be written.  A common period of time is three months, but there is significant variation in both directions.  When two letters are required, the second referral is intended to be an evaluative consultation, not a representation of an ongoing long-term therapeutic relationship, and can be written by a medical practitioner of sufficient experience with gender dysphoria.

Note: Evaluation of candidacy for sex reassignment surgery by a mental health professional is covered under the member’s medical benefit, unless the services of a mental health professional are necessary to evaluate and treat a mental health problem, in which case the mental health professional’s services are covered under the member’s behavioral health benefit. Please check benefit plan descriptions.

Characteristics of a Qualified Mental Health Professional: (From SOC-7)

1. Master’s degree or equivalent in a clinical behavioral science field granted by an institution accredited by the appropriate national accrediting board.  The professional should also have documented credentials from the relevant licensing board or equivalent; and
2. Competence in using the Diagnostic Statistical Manual of Mental Disorders and/or the International Classification of Disease for diagnostic purposes; and
3. Ability to recognize and diagnose co-existing mental health concerns and to distinguish these from gender dysphoria; and
4. Knowledgeable about gender nonconforming identities and expressions, and the assessment and treatment of gender dysphoria; and
5. Continuing education in the assessment and treatment of gender dysphoria.  This may include attending relevant professional meetings, workshops, or seminars; obtaining supervision from a mental health professional with relevant experience; or participating in research related to gender nonconformity and gender dysphoria.
    

The above policy is based on the following references: