MEDICAL COVERAGE POLICY SERVICE: Gender Assignment and Reassignment Surgery. SERVICE: Gender Assignment, Reassignment Surgery or Gender Dysphoria

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1 Gender Assignment and Page 1 of 7 Important note Even though this policy may indicate that a particular service or supply may be considered covered, this conclusion is not based upon the terms of your particular benefit plan. Each benefit plan contains its own specific provisions for coverage and exclusions. Not all benefits that are determined to be medically necessary will be covered benefits under the terms of your benefit plan. You need to consult the Evidence of Coverage to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between this policy and your plan of benefits, the provisions of your benefits plan will govern. However, applicable state mandates will take precedence with respect to fully insured plans and self-funded non- ERISA (e.g., government, school boards, church) plans. Unless otherwise specifically excluded, Federal mandates will apply to all plans. With respect to Senior Care members, this policy will apply unless Medicare policies extend coverage beyond this Medical Policy & Criteria Statement. Senior Care policies will only apply to benefits paid for under Medicare rules, and not to any other health benefit plan benefits. CMS's Coverage Issues Manual can be found on the CMS website. SERVICE: Gender Assignment, or Gender Dysphoria PRIOR AUTHORIZATION: Required POLICY: Note: MAPD, Cost and FEHB plans do NOT exclude surgical and non-surgical treatment for gender reassignment and gender dysphoria. Non-surgical treatment for Gender Reassignment or Gender Dysphoria Plans may cover non-surgical treatment for gender dysphoria. If there is a difference between the Plan documents and the information below, the Plan documents should be used for making benefit determinations. For Plans that cover non-surgical treatment of gender dysphoria the following services are covered: 1. Psychotherapy for gender dysphoria and associated co-morbid psychiatric diagnoses. Note: If mental health services are not otherwise covered (for example when mental health services are carved out of the plan design) mental health services will not be covered for gender dysphoria. 2. Continuous Hormone Replacement Therapy hormones of the desired gender. Hormones injected by a medical provider (for example hormones injected during an office visit) are covered by the medical plan. Benefits for these injections vary depending on the plan design. Oral and self-injected hormones from a pharmacy are NOT covered under the medical plan. There might be specific prescription drug product coverage and exclusion terms that are plan specific. The member must meet ALL of the following eligibility qualifications for hormone replacement: Has the documented diagnosis of gender dysphoria diagnosed by a psychiatrist or psychologist; and Capacity to make a fully informed decision and to consent for treatment; and Age of majority in a given region/country. Where approval or denial of benefits is based solely on the age of the individual a case-by-case medical director review is

2 Gender Assignment and Page 2 of 7 necessary; and If significant medical or mental health concerns are present, they must be reasonably well-controlled. 3. Laboratory testing to monitor the safety of continuous hormone therapy. Coverage Limitations and Exclusions: 1. Treatment received outside of the United States. 2. Non-surgical treatments that are not listed in the Covered Services section above. 3. Reproduction services including, but not limited to: sperm preservation in advance of hormone treatment or gender dysphoria surgery, cryopreservation of fertilized embryos, oocyte preservation, surrogate parenting, donor eggs, donor sperm and host uterus. (See the Reproduction exclusion in the enrollee specific benefit document.) 4. Drugs for hair loss or growth. 5. Drugs for sexual performance for patients that have undergone genital reconstruction. 6. Drugs for cosmetic purposes. 7. Hormone therapy except as described in the Covered Services section above. 8. Pubertal suppression therapy is considered unsafe in managing children and adolescents with gender identity dysphoria and is, therefore, not covered. 9. Voice therapy. 10. Services that exceed the maximum dollar limit on the plan. 11. Transportation, meals, lodging or similar expenses. Surgical Treatment for Gender Reassignment or Gender Dysphoria Most plans exclude coverage for surgical treatment for gender dysphoria. For plans that cover surgical treatment for gender dysphoria, please note the following: First, the member must meet ALL the following criteria prior to surgery: 1. Persistent, well-documented gender dysphoria (see definition of Gender Identity Disorder below); and 2. Capacity to make a fully informed decision and to consent for treatment; and 3. Age of majority in a given region, and 4. If significant medical or mental health concerns are present, these must be reasonably wellcontrolled; and 5. The covered person must complete 12 months of successful continuous full time real life experience in the desired gender, and 6. The covered person may be required to complete continuous hormone therapy (for those without contraindications). In consultation with the patient s physician, this should be determined on a case-by-case basis through the Notification process; and 7. The treatment plan must conform to identifiable external sources including the World Professional Association for Transgender Health Association (WPATH) standards, and/or evidence-based professional society guidance. Once the above criteria are met, the following are covered: 1. Genital Surgery (by various techniques which must be appropriate to each patient), including:

3 Gender Assignment and Page 3 of 7 complete hysterectomy; orchiectomy; penectomy; vaginoplasty; vaginectomy; clitoroplasty; labiaplasty; salpingo-oophorectomy; metoidioplasty; scrotoplasty; urethroplasty; placement of testicular prosthesis; phalloplasty 2. Surgery to change specified secondary sex characteristics, specifically: Thyroid chondroplasty (removal or reduction of the Adam s Apple); and Bilateral mastectomy; and Augmentation mammoplasty (including breast prosthesis if necessary) if the Physician prescribing hormones and the surgeon have documented that breast enlargement after undergoing hormone treatment for 18 months is not sufficient for comfort in the social role. 3. Related Services: In addition to the surgeon fees, the benefit applies to the services related to the surgery, including but not limited to: anesthesia, laboratory testing, pathology, radiologic procedures, hospital and facility fees, and/or surgical center fees. Clarifications for Breast/Chest Surgery 1. A biologic female patient that is only requesting a bilateral mastectomy: Does not need to complete hormone therapy in order to qualify for the mastectomy. Although not a requirement for coverage, SWHP recommends that the patient complete at least 3 months of psychotherapy before having the mastectomy. 2. A biologic male patient that is only requesting a breast augmentation: If able to take female hormones, the patient should take the female hormones for at least months* before being considered for bilateral breast augmentation since the patient may achieve adequate breast development without surgery. Although not a requirement for coverage, SWHP recommends that the patient complete at least 3 months of psychotherapy before having the breast augmentation. Excluded Services for Surgical Treatment of Gender Dysphoria: 1. Treatment received outside of the United States. 2. Reversal of genital surgery or reversal of surgery to revise secondary sex characteristics. 3. Voice modification surgery. 4. Facial feminization surgery, including but not limited to: facial bone reduction, face lift, facial hair removal, and certain facial plastic reconstruction. 5. Suction-assisted lipoplasty of the waist. 6. Rhinoplasty 7. Blepharoplasty 8. Abdominoplasty 9. Breast reduction For plans that do not cover surgical treatment of gender dysphoria, surgical treatments for gender dysphoria are not covered even if considered to be medically necessary by the prescribing physician or other health practitioner. For plans that cover surgical treatment of gender dysphoria, coverage does not apply to enrollees that do not meet the criteria listed in the Eligibility Qualifications for Surgery section above.

4 Definition of Gender Identity Disorder: A disorder characterized by the following diagnostic criteria: 1. A strong and persistent cross-gender identification (not merely a desire for any perceived cultural advantages of being the other sex) 2. Persistent discomfort with his or her sex or sense of inappropriateness in the gender role of that sex 3. The disturbance is not concurrent with a physical intersex condition 4. The disturbance causes clinically significant distress or impairment in social, occupational, or other important areas of functioning. 5. The transsexual identity has been present persistently for at least two years 6. The disorder is not a symptom of another mental disorder or a chromosomal abnormality OVERVIEW: The ability to diagnose infants born with intersex conditions has advanced rapidly in recent years. In most cases today, clinicians can promptly make an accurate diagnosis and counsel parents on therapeutic options. However, the paradigm of early gender assignment has been challenged by the results of clinical and basic science research, which show that gender identity development likely begins in utero. While the techniques of surgical genital reconstruction have been mastered, the understanding of the psychological and social implications of gender assignment is poor. Ambiguous genitalia are those in which it is difficult to classify the infant as male or female. The extent of the ambiguity varies. In very rare instances, the physical appearance may be fully developed as the opposite of the genetic sex (e.g., a genetic male may have developed the appearance of a normal female). Typically, ambiguous genitalia in genetic females (babies with two X chromosomes) include an enlarged clitoris that has the appearance of a small penis. The urethral opening can be anywhere along, above, or below the surface of the clitoris. The labia may be fused, resembling a scrotum. The infant may be thought to be a male with undescended testicles. Sometimes a lump of tissue is felt within the fused labia, further making it look like a scrotum with testicles.in a genetic male (one X and one Y chromosome), ambiguous genitalia typically include a small penis (less than 2-3 centimeters or inches) that may appear to be an enlarged clitoris (the clitoris of a newborn female is normally somewhat enlarged at birth). The urethral opening may be anywhere along, above, or below the penis; it can be placed as low as on the peritoneum, further making the infant appear to be female. There may be a small scrotum with any degree of separation, resembling labia. Undescended testicles commonly accompany ambiguous genitalia. Ambiguous genitalia are usually not life threatening, but can create social upheaval for the child and the family. Making a correct determination of gender is both important for treatment purposes, as well as the emotional well-being of the child. Some children born with ambiguous genitalia may have normal internal reproductive organs that allow them to live normal lives. However, others may experience health issues from an underlying cause of the disorder. A list of the most common causes is listed below: Pseudohermaphroditism, the genitalia are of one sex, but some physical characteristics of the Gender Assignment and Page 4 of 7

5 Gender Assignment and Page 5 of 7 other sex are present. True hermaphrodism, a very rare condition in which both ovarian and testicular tissue is present. The child may have parts of both male and female genitalia. Mixed gonadal dysgenesis (MGD), an intersex condition in which there appears some male structures (gonads, testis), as well as a uterus, vagina, and fallopian tubes. Congenital adrenal hyperplasia (CAH). This condition has several forms, but the most common form causes the genetic female to appear male. (CAH is a potentially life threatening condition.). Chromosomal abnormalities, including Klinefelter s syndrome (XXY) and Turner s syndrome (XO). Maternal ingestion of certain medications (i.e. androgenic steroids) may cause a genetic female to look more male. Lack of production of specific hormones can cause the embryo to develop with a female body type regardless of genetic sex. (Lack of testosterone cellular receptors). Treatment of ambiguous genitalia is controversial. No one debates the need to treat underlying physiologic problems such as those associated with CAH or tumors in the gonads. However treatment for ambiguous genitalia depends on the type of disorder, but will usually include corrective surgery to remove or create reproductive organs appropriate for the gender of the child. Treatment may also include hormone replacement therapy (HRT). Controversy revolves around issues of gender assignment by the physician and family which may not correlate with gender preference by the patient in adulthood. Adequate counseling and support for parents is vital. The ideal management method is a team approach including neonatologists, geneticists, endocrinologists, surgeons, counselors, and ethicists Gender reassignment surgery, also known as transsexual surgery, sex reassignment surgery or intersex surgery, is the culmination of a series of procedures designed to change the anatomy to conform to the gender to which a person with a gender identity disorder identifies themselves. Gender reassignment surgery entails castration, penectomy and vulva-vaginal construction for male to female gender reassignment. Female to male surgery includes bilateral mammectomy, hysterectomy, salpingo-oophorectomy, followed by phalloplasty and insertion of testicular prosthesis. Gender reassignment surgery is controversial among the available literature and few long term studies can be located. These controversial differences are most apparent due to the far reaching and irreversible results of hormonal and/or surgical transformation and the high rate of serious complications of these procedures. MANDATES: None CODES: Important note: CODES: Due to the wide range of applicable diagnosis codes and potential changes to codes, an inclusive list may not be presented, but the following codes may apply. Inclusion of a code in this section does not guarantee that it will be reimbursed, and patient must meet the criteria set forth in the policy language. CPT Codes: 54125,54400, 54401, 54405, 54660, 55970, 55980, 56805, 57291,

6 57292,57295, 57296, 57335, 57426, CPT Not Covered: ICD9 codes: ,302.51, , , 302.6, , 752.7, , , 62.41, 62.7, 64.3, 64.43, 64.5, 64.97, ICD10 codes F64.1 Transexualism/Gndr ident d/o adult/adolescent F64.2 Gender identity d/o childhood Q56.0 Hermaphroditism, NEC Q56.1 Male pseudohermaphroditism, NEC Q56.2 Female pseudohermaphroditism, NEC Q56.3 Pseudohermaphroditism, NEC Q56.4 Indtrm sex/ambiguous genitalia, NEC E25.0 Congn adrenogenital d/o assoc enzyme defcncy Q96.0 Turner's karyotype 45,X Q96.1 Turner's karyotype 46, X iso (Xq) Q96.2 Karyotype 46, X w/abnrm sex chrmsm excpt iso (Xq) Q96.3 Mosaicism, 45, X/46, XX or XY Q96.4 Mosaicism, 45, X/other cell line(s) with abnormal sex chromosome Q96.8 Other variants of Turner's Syndrome Q96.9 Turner's Syndrome, unsp. Q52.9 Congenital malformation female genitalia, unsp Q55.9 Congenital malformation male genital organ, unsp CMS: NCD for Transsexual Surgery. Centers for Medicare & Medicaid Services. Baltimore, Maryland. Publication Number 13-3, Manual Section Number 140.3, was nullified on May30, 2014 (Decision 2576) POLICY HISTORY: Status Date Action New 12/6/2010 New policy Reviewed 12/6/2011 Reviewed. Reviewed 10/25/2012 Reviewed. Reviewed 10/3/2013 No changes Reviewed 08/21/2014 No changes Reviewed 04/30/2015 Added pharmacologic and consultation exclusion. Reviewed 09/03/2015 Updated to include criteria for coverage where permitted. REFERENCES: The following scientific references were utilized in the formulation of this medical policy. SWHP will continue to review clinical evidence related to this policy and may modify it at a later date based upon the evolution of the published clinical evidence. Should additional scientific studies become available and they are not included in the list, please forward the reference(s) to SWHP so the information can be reviewed by the Medical Coverage Policy Committee (MCPC) and the Quality Improvement Committee (QIC) to determine if a modification of the policy is in order. 1. Transsexual Surgery: Its Pros and Cons. Comprehensive Exam Essay. Transsexual Women s Resources. Medical and Other Resources for Transsexual Women (2000) < com>.krege, S., Bex, A., Gender Assignment and Page 6 of 7

7 et al. Male-to female transsexualism: a technique, results, results and long- term follow-up in 66 patients. Ingentaconnect (2001 September) 88(4): (7). 2. Nuttbrock, L., Rosenblum, A., et al. Transgender Identity Affirmation and Mental Health. The International Journal of Transgenderism (2002) 6(4): Wagner, I., Fugain, C., et al. Pitch-raising surgery in fourteen male-to-female transsexuals. Laryngoscope (2003 July) 113(7): Fang, R.H., Chen, T.J., et al. Anatomic study of vaginal width in male-to-female transsexual surgery. Plastic and Reconstructive Surgery (2003 August) 112(2): emedicine.com Hutcheson, Joel. Ambiguous genitalia and intersexuality. May 26, emedicine Pediatric Continuing Education. (19 October 2005) < emedicine com> 6. Hart, Anita C., and Catherine A. Hopkins. ICD-9-CM Professional for Physicians Volumes I & 2. Salt Lake, Utah: Ingenix (2004 October 1). 7. Rethinking the gender Identity disorder terminology in the Diagnostic and Statistical Manual of Mental Disorders. Position Paper, Bologna, Italy: HBIGDA Conference (2005 April 7). < avitale.com>. 8. Kanagalingam, J., Georgalas, C., et al. Cricothyroid approximation and subluxation in 21 male-to-female transsexuals. Laryngoscope (2005 April) 115(4): Sobralske, M. Primary care needs of patients who have undergone gender reassignment. Journal of the American Academy of Nurse Practitioners (2005 April) 17(4): Mayer-Bahlburg, H.F. Introduction: gender dysphoria and gender change in persons with intersexuality. Archives of Sexual Behavior (2005 August) 34(4): Gender Assignment and Page 7 of 7