Horizon BCBSNJ Uniform Medical Policy Manual Policy Number: 115 Effective Date: 01/01/2017

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1 Horizon BCBSNJ Uniform Medical Policy Manual Section: Surgery Policy Number: 115 Effective Date: 01/01/2017 Original Policy Date: 05/25/2010 Last Review Date: 05/10/2016 Date Published to Web: 06/23/2010 Subject: Gender Reassignment Surgery Description: IMPORTANT NOTE: The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively Horizon BCBSNJ ) insures or administers. If the member s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member. Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment. Gender dysphoria, previously known as gender identity disorder, is a condition in which a person feels a strong and persistent identification with the opposite gender accompanied with a severe sense of discomfort in their own gender. People with gender dysphoria often report a feeling of being born the wrong sex or "trapped in the wrong body". Gender dysphoria is broadly defined as a discomfort or distress that is caused by a discrepancy between a person's gender identity and that person's sex assigned at birth (and the associated gender role and/or primary and secondary sex characteristics). 8 The diagnosis of gender dysphoria can be established at childhood, adolescence, or adulthood. People who wish to change their sex may be referred to as "transsexuals". In May 2013, the American Psychiatric Association published an update to their Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). This update included a significant change to the nomenclature of conditions related to gender psychology. Specifically,

2 the term "Gender Identity Disorder (GID)" was replaced with "Gender Dysphoria". 8 Additionally, the DSM-5 provided updated diagnostic criteria for gender dysphoria for both children and adults. However, ICD-9 and ICD-10 codes continue to use the term gender identity disorder. Due to the far-reaching and irreversible results of hormonal and/or surgical transformational measures, a step-wise approach to therapy for GID, including accurate diagnosis and long-term treatment by a multidisciplinary team including behavioral, medical and surgical specialists, is vital to the patient's best interest. As with any treatment involving psychiatric disorders, a thorough behavioral analysis by a qualified practitioner is needed. After the diagnosis of gender dysphoria is made, the therapeutic approach to gender dysphoria usually includes three elements or phases (sometimes labeled triadic therapy): hormones of the desired gender, a real-life experience in the desired role, and surgery to change the genitalia and other sex characteristics. The most typical order, if all three elements are undertaken, is hormones followed by real-life experience and, finally surgery to change the genitalia and other sex characteristics. However, the diagnosis of gender dysphoria invites the consideration of a variety of therapeutic options, only one of which is the complete therapeutic triad. Clinicians have become increasingly aware that not all persons with gender dysphoria need or want all three elements of triadic therapy. Hormone therapy is administered under medical supervision and is important in the gender transition process by altering body hair, breast size, skin appearance and texture, body fat distribution, and the size and function of sex organs. Additionally, real-life experience is important to validate the individual's desire and ability to incorporate into their desired gender role within their social network and daily environment. This generally involves gender-specific appearance (garments, hairstyle, etc.), involvement in various activities in the desired gender role including work and academic settings, legal acquisition of a gender appropriate first name, and acknowledgement by others of their new gender role. Gender reassignment surgery is one treatment option for extreme cases of gender dysphoria. Gender reassignment surgery is not a single procedure, but part of a complex process involving multiple medical, psychiatric, and surgical specialists working in conjunction with each other and the individual to achieve successful behavioral and medical outcomes. Before undertaking gender reassignment surgery, important medical and psychological evaluations, medical therapies and behavioral trials are undertaken to confirm that surgery is the most appropriate treatment choice for the individual Surgical treatment differs depending upon the original physical gender of the individual. For male-to-female patients, also known as " transwomen", surgery involves removal of the testicles and penis and the creation of a pseudo vagina, clitoris, and labia. For female-to-male patients, also known as "transmen", surgery involves removal of the uterus, ovaries, and vagina, and creation of a neophallus, and scrotum with scrotal prostheses. Additional surgical procedures may also be performed to improve the gender appropriate appearance of the individual. These include, but are not limited to, breast augmentation, liposuction, Adam's apple reduction, voice modification surgery (vocal cord shortening), rhinoplasty, facial reconstruction (facial bone reduction, jaw shortening, sculpturing), lip reduction, and chin implants.

3 Policy: I. Contract exclusions and/or limitations for gender reassignment surgery, including related services such as medical counseling, psychological clearance for surgery in the absence of a need for behavioral health therapeutic services, and hormonal therapy, will determine the available benefit for gender reassignment surgery. II. For contracts that specify gender reassignment surgery and related services as a covered benefit and have specific benefit applications and/or limitations for gender reassignment surgery, such specific benefit applications and/or limitations will apply. III. If coverage for gender reassignment surgery is available, it is considered medically necessary when all of the criteria specified in III.A, III.B, III.C, or III.D. are met: A. Criteria for mastectomy and creation of a male chest in female-to-male members: 1. Single letter of referral from a qualified mental health professional (see Policy Guidelines** ***), and 2. Persistent, well-documented gender dysphoria (see Policy Guidelines*); and 3. Capacity to make a fully informed decision and to give consent for treatment; and 4. Age of majority (18 years of age or older); and 5. If significant medical or mental health concerns are present, they must be reasonably well controlled. (NOTE: Hormone therapy is not a pre-requisite.) B. Criteria for breast augmentation (implants/lipofiling) in male-to-female members: 1. Single letter of referral from a qualified mental health professional (see Policy Guidelines** ***), and 2. Persistent, well-documented gender dysphoria (see Policy Guidelines*); and 3. Capacity to make a fully informed decision and to give consent for treatment; and 4. Age of majority (18 years of age or older); and 5. If significant medical or mental health concerns are present, they must be reasonably well controlled. (NOTE: Although not an explicit criterion, it is recommended that male-to-female members undergo feminizing hormone therapy (minimum of 12 months) prior to breast augmentation surgery. The purpose is to maximize breast growth in order to obtain better surgical/aesthetic results.) C. Criteria for gonadectomy (hysterectomy and oophorectomy in female-to-male members and orchiectomy in male-to-female members): 1. Two letters of referral from qualified mental health professionals, one in a purely evaluative role (see Policy Guidelines** ***), and 2. Persistent, well-documented gender dysphoria (see Policy Guidelines*); and 3. Capacity to make a fully informed decision and to give consent for treatment; and

4 4. Age of majority (18 years of age or older); and 5. If significant medical or mental health concerns are present, they must be reasonably well controlled; and 6. Twelve (12) continuous months of 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). (NOTE: The aim of hormone therapy prior to gonadectomy is primarily to introduce a period of reversible estrogen or testosterone suppression, before the member undergoes irreversible surgical intervention.) D. Criteria for genital reconstructive surgery (i.e., any combination of the following: vaginectomy, urethroplasty, metoidioplasty, phalloplasty, scrotoplasty, and implantation of erection and/or testicular prosthesis in female-to-male members; penectomy, vaginoplasty, labiaplasty, vulvoplasty and clitoroplasty in male-to-female members). 1. Two letters of referral from qualified mental health professionals, one in a purely evaluative role (see Policy Guidelines** ***), and 2. Persistent, well-documented gender dysphoria (see Policy Guidelines*); and 3. Capacity to make a fully informed decision and to give consent for treatment; and 4. Age of majority (18 years of age or older); and 5. If significant medical or mental health concerns are present, they must be reasonably well controlled; and 6. Twelve (12) continuous months of 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 (12) continuous months of living in a gender role that is congruent with their gender identity (real life experience). (NOTE: Although not an explicit criterion, it is recommended that these members also have regular visits with a mental health or other medical professional.) (NOTE: The above criteria are consistent with The World Professional Association for Transgender Health (WPATH) Standards of Care for the Health of Transsexual, Transgender, and Gender-Nonconforming People. (7th Version). 10 ) IV. The following gender reassignment-related surgical procedures are eligible for coverage when the corresponding medical necessity criteria are met: A. Male-to-female: 1. Breast/chest surgery 2. Genital surgery augmentation mammoplasty (implants/lipofiling) penectomy orchiectomy vaginoplasty

5 clitoroplasty labiaplasty vulvoplasty B. Female-to-male: 1. Breast/chest surgery 2. Genital surgery mastectomy (subcutaneous) creation of a male chest hysterectomy oophorectomy urethroplasty metoidioplasty phalloplasty vaginectomy scrotoplasty implantation of erection and/or testicular prosthesis V. Non-genital, non-breast aesthetic surgical procedures are considered cosmetic in nature, even in the presence of a contract benefit for gender reassignment surgery. These include, but may not be limited to, the following: A. Procedures that assist in feminization (male-to-female): reduction thyroid chondroplasty (trachea shave) suction-assisted lipoplasty of the waist rhinoplasty facial feminization surgery / facial bone reduction / jaw shortening / sculpturing face-lift blepharoplasty voice modification surgery (vocal cord shortening) hair reconstruction / hair removal / electrolysis rhytidectomy gluteal augmentation (implants/lipofiling) B. Procedures that assist in masculinization (female-to-male): voice surgery (rare) liposuction (e.g., reduce fat in hips, thighs, and buttocks) pectoral implants chin implants

6 lip reduction Policy Guidelines: (Information to guide medical necessity determination based on the criteria contained within the policy statements above.) * 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 indicators: 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) ** Format and content of referral letters for surgery from Qualified Health Professionals: (From WPATH Standards of Care, 7th Version 10 ) 1. The 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 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: One referral from a qualified mental health professional is needed for breast surgery (e.g., mastectomy). Two referrals from qualified mental health professionals who have independently assessed the patient are needed for genital surgery (i.e.,

7 hysterectomy/salpingo-oophorectomy, orchiectomy, genital reconstructive surgeries). If the first referral is from the patient s psychotherapist, the second referral should be from a person who has only had an evaluative role with the patient. Two separate letters, or one letter signed by both (e.g., if practicing within the same clinic) may be sent. Each referral letter, however, is expected to cover the same topics in the areas outlined above. *** Characteristics of a Qualified Mental Health Professional: (From WPATH Standards of Care, 7th Version 10 ) 1. A master s degree or its equivalent in a clinical behavioral science field. This degree or a more advanced one should be granted by an institution accredited by the appropriate national or regional accrediting board. The mental health 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 Diseases 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. 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 Supplemental Information: Centers for Medicare and Medicaid Services (CMS): 5,9 According to the National Coverage Determination (NCD) for Transsexual Surgery (140.3), "Because of the lack of well controlled, long term studies of the safety and effectiveness of the surgical procedures and attendant therapies, the treatment is considered experimental. Moreover, there is a high rate of serious complications for these surgical procedures. For these reasons, transsexual surgery is not covered." 5 This NCD has been invalidated effective May 30, (see below) According to Pub Medicare National Coverage Determinations (Transmittal 169), the Department of Health and Human Services Departmental Appeals Board (DAB) has invalidated National Coverage Determination (NCD) Transsexual Surgery pursuant to section 1869(f)(1)(A)(iii) of the Social Security Act (SSA). (Docket #A-13-47, Decision #2576) dated May 30, As a consequence of this decision, NCD is no longer valid effective May 30, Because the NCD is no longer valid as of the effective date, its provisions are no longer a basis for denying claims for Medicare coverage of transsexual surgery under 42 CFR Moreover, any local coverage determinations used to adjudicate such claims may not be based

8 on or rely on the provisions or reasoning from section of Pub , Medicare NCD Manual. In the absence of an NCD, contractors and adjudicators should consider whether any Medicare claims for these services are reasonable and necessary under 1862(a)(1)(A) of the SSA consistent with the existing guidance for making such decisions when there is no NCD. 9 For further details, please go to: Guidance/Guidance/Transmittals/2014-Transmittals-Items/R169NCD.html] 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. Index: Gender Dysphoria References: 1. The World Professional Association for Transgender Health (WPATH), formerly known as the Harry Benjamin International Gender Dysphoria Associaion, HBIGDA). Standards of Care for Gender Identity Disorders, Sixth Version. February, Available at: (last accessed 03/25/2010) 2. Hembree WC, Cohen-Kettenis P, et al; Endocrine Society. Endocrine treatment of transsexual persons: an Endocrine Society clinical practice guidelines. J Clin Endocrinol Metab Sep;94(9): Epub 2009 Jun 9. Available at: (current version as of 08/08/2015) 3. Day P. Tech Brief Series. Trans-gender Reassignment Surgery. New Zealand Health Technology Assessment (NZHTA) Report 2002;1(1). 4. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fourth Edition, Text Revision. (DSM-IV-TR)

9 5. Centers for Medicare and Medicaid Services (CMS). NCD for Transsexual Surgery (140.3). Available at: 40%2E3%3A1%3ATranssexual+Surgery. 6. ECRI Institute s Health Technology Assessment Information Service (HTAIS). Hotline Response: Sexual Reassignment for Gender Identity Disorders. Updated: 12/30/2009. (last accessed 04/05/2010) 7. Byne W, Bradley SJ, Eyler AE et al. Report of the American Psychiatric Association Task Force on Treatment of Gender Identity Disorder. Arch Sex Behav Aug;41(4): American Psychiatric Association. Gender Dysphoria - explanation of replacing "disorder" with "dysphoria" in DSM 5. Available at: 9. CMS Manual System. Pub Medicare National Coverage Determination (Transmittal 169). Subject: Invalidation of National Coverage Determination Transsexual Surgery. Effective date: May 30, Available at: Guidance/Guidance/Transmittals/2014-Transmittals-Items/R169NCD.html 10. The World Professional Association for Transgender Health (WPATH). Standards of Care for the Health of Transsexual, Transgender, and Gender-Nonconforming People. 7th Version Available at: %202011%20WPATH.pdf 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* HCPCS * CPT only copyright 2016 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage. The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties

10 without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy