procedures as those treatments directed at improving appearance, but provides as an exception surgeries needed for therapeutic purposes which coincidentally also serve some cosmetic purpose.2 The essential purpose of transition-related treatment is to therapeutically treat Gender Dysphoria, not to improve a person’s appearance. The evaluation of medical necessity must therefore be individualized to each patient and take into account the totality of the patient’s total gendered appearance and transition-related needs. Transgender people have unique clinical needs that are distinct from those of non-transgender people, and individualized assessments should be based on their symptoms, functionality, and the total gendered appearance. All of the surgical procedures used to treat transgender patients by definition are designed to change the physical appearance of the body to have the gendered characteristics of the other physical sex. However, the purpose of 1 See HHS DAB NCD 140.3, Transsexual Surgery, Docket No. A-13-87, Decision No. 2576 (May 30, 2014) (the “NCD 140.3 Decision”). 2 Cosmetic surgery includes any surgical procedure directed at improving appearance, except when required for the prompt (i.e., as soon as medically feasible) repair of accidental injury or for the improvement of the functioning of a malformed body member. For example, this exclusion does not apply to surgery in connection with treatment of severe burns or repair of the face following a serious automobile accident, or to surgery for therapeutic purposes which coincidentally also serves some cosmetic purpose. Medicare Benefit Policy Manual, Chapter 16 – General Exclusions from coverage 120 - Cosmetic Surgery (Rev. 1, 10-01-03) A3-3160, HO-260.11, B3-2329. Gender Reassignment Surgery Model NCD | 2 such procedures is not to make patients more attractive, but to make them appear as much as possible like members of the sex to which they are transitioning. Ultimately, the clinical purpose is to treat the gender dysphoria that arises from having a physical body that is not congruent with their gender identity. Thus the surgeries that by CMS definition are cosmetic are also covered under the Medicare Benefit Policy Manual (see footnote 2, above) and is thus a surgery for therapeutic purposes which coincidentally also serves some cosmetic purpose. True randomized studies may not be feasible and may be unethical in the context of genderaffirming surgery.3,4,5 In its decision invalidating the NCD, however, the Departmental Appeal Board stated that the general acceptance of the medical necessity of such surgeries in the international medical community provided a sound scientific basis for coverage despite the lack of randomized studies.6 The Departmental Appeals Board held that “[r]egardless of whether” evidence regarding the medical necessity of gender-affirming surgery “meets the first option for meeting the evidentiary standard set forth in the guidance . . . it clearly meets the second option because it indicates a consensus among researchers and mainstream medical organizations that transsexual surgery is an effective, safe and medically necessary treatment for transsexualism.” Professional organizations supporting treatment for Gender Dysphoria, including Gender Reassignment Surgery, include American Medical Association, American Academy of Family Physicians, the Endocrine Society, American Psychiatric Association, American Psychological Association, American College of Obstetricians and Gynecologists, and the American Public Health Association. 7 The World Professional Association for Transgender Health (WPATH) is broadly recognized as the worldwide authority on transgender health issues.8 The Departmental Appeals Board concluded that the WPATH Standards of Care have attained widespread acceptance in the medical community and are accepted by federal courts as the generally accepted protocols for the treatment of Gender Dysphoria. 9 In accordance with the findings of the DAB, the provisions of this NCD have been reviewed to ensure that they do not conflict with the operable WPATH Standards of Care (Version 7, 2011). Gender Identity Disorder (GID) or Gender Dysphoria (GD) is the formal diagnosis used to describe persons who experience significant and persistent distress between the individual’s 3 De Vries AL, Steensma TD, Doreleijers TA, Cohen-Kettenis PT. Puberty suppression in adolescents with gender identity disorder: A prospective follow-up study. The Journal of Sexual Medicine. 2011;8(8):2276–2283. 4 Drescher J, Byne W. Gender dysphoric/gender variant (GD/GV) children and adolescents: Summarizing what we know and what we have yet to learn. Journal of homosexuality. 2012;59(3):501–510. 5 Murad MH, Elamin MB, Garcia MZ, et al. Hormonal therapy and sex reassignment: a systematic review and metaanalysis of quality of life and psychosocial outcomes. Clinical Endocrinology. 2010;72(2):214–231. 6 “NCD 140.3 Decision” at 20. 7 Lambda Legal. Professional Organization Statements Supporting Transgender