Title: Policy Counsel
Organization: National Center for Transgender Equality
January 2, 2015
RE: National Coverage Determination for Gender Dysphoria and Gender Reassignment Surgery
On behalf of the National Center for Transgender Equality, Transgender Law Center and Justice in Aging, we appreciate the opportunity to comment on the proposed NCD for Gender Reassignment Surgery. While we have joined separate comments addressing in detail the clinical evidence for covering these procedures, these comments address CMS's responsibility to ensure that the NCD comply with the legal requirements of the Affordable Care Act.
The NCD must comply with the nondiscrimination requirements of the Affordable Care Act.
The NCD must be consistent not only with current medical research, but also with the nondiscrimination principles and standards of Section 1557 of the Affordable Care Act. HHS has affirmed that Section 1557 prohibits health coverage practices that result in discrimination on the basis of gender identity.1 Its recent proposed rule implementing Section 1557 enumerated a range of coverage policies and practices that arbitrarily and discriminatorily single out transgender people by denying them benefits provided to non-transgender people and limiting their access to essential care solely based on their gender identity.2 The requirements set out in the proposed nondiscrimination rule apply to health programs administered by CMS, including Medicare,3 as well as recipients of Medicare funds apart from Medicare Part B payments.4 Issuing an NCD is necessary to ensure uniform compliance with these nondiscrimination requirements.
Section 1557 prohibits automatic exclusions of medically necessary treatments for Gender Dysphoria.
HHS has recognized that many restrictions on coverage for treatments of Gender Dysphoria unlawfully discriminate against transgender people, in violation of Section 1557. For example, a covered entity may not categorically exclude any and all care related to gender transition.5 The Department of Appeals Board's 2014 decision striking down Medicare's categorical exclusion of surgical treatments for Gender Dysphoria brought the Medicare program closer in line with both the overwhelming medical evidence regarding the safety, efficacy and medical necessity of such treatment and with CMS's legal obligations under Section 1557. 6
HHS further clarified that, even in the absence of a blanket exclusion of transition-related care, certain coverage exclusions of specific services may also constitute illegal discrimination.7 For example, the proposed rule made clear that Section 1557 prohibits policies that deny coverage for services used in the treatment of Gender Dysphoria when similar services are covered for the purpose of treating other conditions.8 Most therapeutic services used in the treatment of Gender Dysphoria are analogous to therapeutic services that are regularly covered under Medicare for other medical conditions for non-transgender individuals.9 For example, Medicare covers mastectomies and reconstructive surgeries for the treatment of breast cancer10 and reconstructive facial surgeries to repair serious injuries.11 Denying coverage for substantially similar reconstructive surgeries simply because those procedures are used for the treatment of Gender Dysphoria would constitute unlawful discrimination against transgender people in violation of Section 1557.
In some circumstances, implementing a nondiscriminatory coverage policy based on medical necessity will require coverage of services for treating Gender Dysphoria that are usually considered cosmetic and therefore not covered for other conditions. For example, procedures such as augmentation mammoplasty or permanent hair removal, which are cosmetic in most contexts and excluded from coverage, may be medically necessary in the context of Gender Dysphoria. The essential purpose of transition-related treatment, whether it is genital reconstructive surgery or any other gender reassignment procedure, is to therapeutically treat Gender Dysphoria, not to improve a person's appearance.
A coverage policy that classifies these often life-saving treatments as cosmetic and makes coverage of those treatments subject to the same exclusion as procedures that are cosmetic when performed on non-transgender people misconstrues the nature of transition-related care. Such a policy unlawfully discriminates against transgender people: whereas non-transgender people affected by the policy are merely denied coverage for aesthetic, non-essential services, transgender people under the same policy are denied coverage for medically necessary care that is inherently tied to their transgender status.12 The automatic classification of certain treatments of Gender Dysphoria, in spite a physician's determination of medical necessity for any particular individual, is a denial of coverage that clearly results in discrimination against transgender beneficiaries and is a direct violation of Section 1557.
Distinguishing procedures that can be medically necessary in the context of treating dysphoria from superficially comparable procedures used for cosmetic purposes is consistent with existing Medicare policy of providing coverage for procedures that are normally considered cosmetic when those services are used for medically necessary purposes:
Cosmetic surgery includes any surgical procedure directed at improving appearance, except when required for the…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.13
Accordingly, the NCD should clarify that no procedures recognized by the WPATH Standards as potentially medically necessary for the treatment of Gender Dysphoria are to automatically be classified as cosmetic and therefore excluded from coverage, regardless of whether they are cosmetic in most other contexts or have an incidental function of changing an individual's appearance. Rather, the NCD must allow for the coverage of these procedures when they are clinically indicated for the treatment of Gender Dysphoria, as determined by a qualified health care professional based on the patient's clinical history and presentation and the most up-to-date version of the WPATH Standards of Care.
The NCD should set nondiscriminatory and clinically supported standards for medical necessity.
HHS has recognized that the nondiscrimination requirements of Section 1557 apply not only to the outright exclusion of services related to gender transition, but also to any limitation on coverage that "results in discrimination against a transgender individual."14 A covered entity may not circumvent the nondiscrimination protections in the Affordable Care Act by employing discriminatory benefit designs and policies that create onerous and unjustifiable barriers to coverage that make it impossible or highly impractical for transgender people to access essential care. For example, a covered entity cannot impose arbitrary and excessive standards that are not supported by sound medical evidence for determining eligibility or medical necessity of transition-related procedures, such as by requiring mandatory waiting periods or hormone treatment before covering chest reconstructive surgery15 or a minimum period of psychotherapy before covering hormonal or surgical interventions.16
While some commercial insurance policies still retain these criteria, the medical community has long since recognized that these prerequisites to care have no clinical basis, but rather developed out of outdated perceptions of transgender identities as disordered, abnormal and frequently illusory. Denying coverage based on widely discredited assumptions about transgender people rather than sound clinical practice is inherently discriminatory. In order to comply with the requirements of Section 1557 and prevent unlawfully discriminatory limitations and denials, the NCD should recognize that determinations of medical necessity must be based on mainstream clinical literature and the most recent version of the WPATH Standards of Care, rather than past or present commercial insurance practices or biased assumptions about transgender people or their health needs.17
By issuing an NCD based on the well-established medical standards regarding the treatment of Gender Dysphoria and the determination of medical necessity for each individual, CMS can comply with its legal obligations under the ACA and prevent the misapplication or inconsistent interpretation of the law in local coverage determinations by individual contractors. Ensuring that the NCD does not run afoul of the nondiscrimination provisions of Section 1557-such as by excluding treatments for Gender Dysphoria that are covered for other conditions, basing an exclusion of medically necessary treatments on their classification as cosmetic in unrelated contexts, or imposing criteria for coverage that are not clinically supported-CMS can ensure compliance with the ACA and avoid the possibility of nondiscrimination complaints or litigation against CMS or its contractors.
We thank you for your work to ensure that all Medicare beneficiaries have access to medically necessary gender reassignment surgery and for your consideration of our comments.
National Center for Transgender Equality
Justice in Aging
Transgender Law Center
1. Nondiscrimination in Health Programs and Activities, 80 Fed. Reg. 54,172 (proposed Sept. 8, 2015) (to be codified at 45 C.F.R. pt. 92).
2. Id. To date, 12 states (California, Colorado, Connecticut, Illinois, Massachusetts, Minnesota, New York, Nevada, Oregon, Rhode Island, Vermont, and Washington State) and the District of Columbia have adopted similar interpretations of the ACA and/or their own state nondiscrimination laws with respect to health insurance.
3. Id. at 54,195.
4. Id. at 54,194.
5. Id. at 54,219.
6. See Dep't of Health & Human Serv., NCD 140.3, Transsexual Surgery, 11 (2014).
7. See Nondiscrimination in Health Programs and Activities, 80 Fed. Reg. at 54220.
8. Id. at 54,190. State nondiscrimination laws applicable to insurance have been interpreted similarly. See, e.g., 10 Cal. Admin. Code § 2561.2(a)(4) (prohibiting exclusion of services for gender transition "if coverage is available for those services under the policy when the services are not related to gender transition"); Oregon Insurance Division Bulletin INS 2012-1 ("A health insurer may not deny or limit coverage or deny a claim for a procedure provided for [gender dysphoria] if the same procedure is allowed in the treatment of another [non-GD] condition").
9. See Dep't of Health and Human Servs., NCD 140.3, Transsexual Surgery, 11 (2014).
10. Dep't of Health and Human Servs., NCD 140.2, Breast Reconstruction Following Mastectomy (1997).
11. See Medicare Benefit Policy Manual, Chapter 16 - General Exclusions From Coverage; 120 - Cosmetic Surgery.
12. Cf., e.g., EEOC on Coverage of Contraception, (Dec. 14, 2000) (holding that exclusion of hormonal contraceptive discriminates against women because virtually all persons affected are women), http://www.eeoc.gov/policy/docs/decisioncontraception.html; Cooley v. Daimler Chrysler Corp., 281 F.Supp.2d 979 (E.D. Mo. 2003) (same).
13. Medicare Benefit Policy Manual, Chapter 16 - General Exclusions From Coverage; 120 - Cosmetic Surgery.
14. Nondiscrimination in Health Programs and Activities, 80 Fed. Reg. at 54220.
15. See World Prof. Ass'n for Transgender Health, Standards of Care of the Health of Transsexual, Transgender, and Gender Nonconforming People, Seventh Edition, 34, 59 (2011) [hereinafter SOC 7] (indicating that no minimum period of living as one's identified gender is required before chest reconstructive surgery, and that "[h]ormone therapy is not a prerequisite" to masculine chest reconstructive surgery and recommended but not required for feminine chest reconstructive surgery)
16. See Stephen B. Levine et al., Harry Benjamin International Gender Dysphoria Association's The Standards of Care for Gender Identity Disorders, Fifth Edition 20 (1998) (eliminating psychotherapy as a requirement for any transition-related therapy: "[t]he SOC committee is wary of insistence on some minimum number of psychotherapy sessions for the real life experience, hormones, or surgery, [because] patients differ widely in their abilities to attain similar goals in a specified time [and] minimum number of sessions tend to be construed as a hurdle which tends to be devoid of the genuine opportunity for personal growth."); see also SOC 7, supra note 14, at 1 n. 2 (emphasizing that treatment for Gender Dysphoria should not be determined based on previous version of the Standards of Care: "Standards of Care (SOC), Version 7 represents a significant departure from previous versions. Changes in this version are based upon significant cultural shifts, advances in clinical knowledge, and appreciation of the many health care issues that can arise for transsexual, transgender, and gender nonconforming people….").
17. See, e.g. Minn. Dep't of Commerce and Minn. Dep't of Health, Admin. Bulletin 2015-5 (pursuant to state nondiscrimination law, "[d]etermination of medical necessity and prior authorization protocols for gender dysphoria-related treatment must be based on the most recent, published medical standards set forth by nationally recognized medical experts in the transgender health field"), http://mn.gov/commerce-stat/pdfs/bulletin-insurance-2015-5.pdf.
Title: Chair, Medical and Research Policy Committee
Organization: Advocates for Informed Choice
January 2, 2016
To: Centers for Medicare & Medicaid Services (CMS)
From: Advocates for Informed Choice (AIC)
Re: National Coverage Analysis (NCA) for Gender Dysphoria
and Gender Reassignment Surgery (CAG-00446N)
Submitted electronically at:
These comments are submitted on behalf of Advocates for Informed Choice. We are an international organization and the only US organization providing legal advocacy for children and youth with intersex traits/DSD (differences or disorders of sex development). (More information can be found at: www.aiclegal.org.)
CMS posed the broad question: “… whether gender reassignment surgery and gender dysphoria treatments can boost health outcomes in the US” in the context of Medicaid coverage of care for trans people. Our comments here focus on the needs of intersex people, who are born with atypical reproductive characteristics. In standards of care for typical children with gender dysphoria (GD), timing of interventions is based on the recognition that GD may not persist into adulthood (1). In direct contrast, intersex babies whose genital appearance does not fit a clear male or female binary are assigned a gender, and often subjected to irreversible cosmetic genital surgery before they are old enough to express their gender identity or to consent. (2, 3) When children’s eventual gender identity is discordant with their assigned gender, this can be a form of involuntary sex reassignment surgery. In both GD or DSD, gender reassignment surgery and hormonal therapy that changes genital appearance is not appropriate in unconsenting young children, but may benefit adolescents and adults who understand and desire it. Our concerns regarding Medicaid coverage of current clinical practices for intersex/DSD care include uncertain gender outcomes in young children subjected to genital surgery; unproved benefits of surgery; risks including anesthetic neurotoxicity; lack of coverage of psychosocial care; and international standards declaring that surgery on unconsenting children is a human rights violation.
An estimated 1-2% of babies are born with intersex traits, reproductive or sexual anatomy, and/or chromosome pattern, that do not fit typical definitions of male or female. These traits are typically referred to in medical terminology as DSD. Diagnoses include 46, XX “masculinizing/virilizing” congenital adrenal hyperplasia (CAH), androgen insensitivity syndrome (AIS), partial and complete gonadal dysgenesis (GD), Klinefelter syndrome (KS), Turner syndrome (TS), hypospadias, epispadias and others. (4)
The Institute of Medicine (IOM) and National Institutes of Health (NIH) recognize the intersex community as a sexual and gender minority that is underserved and vulnerable to healthcare discrimination, similar to lesbian, gay, bisexual and transgender people (5, 6; also see attached "AIC HHS Non-discrimination Comment 11.6.15"). Historically, a medicalized model of intersex care prescribed irreversible surgical cosmetic “normalization” of “ambiguous” genitals in infancy. (4) While care for some intersex/DSD conditions has changed, genitoplasty is still performed on some children too young to express their gender identity. (2) In 46, XX CAH, lack of an adrenal enzyme produces androgens that can cause genital difference in children with XX chromosomes. Some children may have typical male genitals. In spite of recent scholarship suggesting that female-assigned children show at least as much cross-gender identification (CGI) as typical girls who meet criteria for referral to a gender clinic, with persistence into adulthood, genital surgery is still commonly performed in 46, XX CAH (7). In addition to discordant gender outcomes, other negative consequences of nonconsensual genital surgery can include involuntary sterilization and loss of sexual function and sensitivity (8, 9). Despite 50 years of technical improvement, the benefits of early childhood surgery remain unproved (10, 11). New global recommendations to defer non-essential surgery are based on risks of anesthetic neurotoxicity to the developing brain, especially in young children (12, 13), representing another potential harm of early childhood cosmetic genital surgery. In a non-medicalized (14), psychosocial model promoted by intersex advocates, genital differences are considered natural variations along a spectrum of difference. While isolation and misunderstanding can cause distress for families and individuals, intersex in and of itself does not compromise health and wellbeing.
Postponing irreversible surgical and hormonal intervention in a psychoeducational model of care supports ethical obligations to ensure children’s right to physical autonomy and an “open future” in which they make their own decisions about their bodies (15). The United Nations High Commissioner for Human Rights affirms that, “our diversity – the differences between our experiences and perspectives, as well as the shapes of our bodies – is something that we should celebrate and protect, in all its forms.” (16) We urge the Department of Health and Human Services to prioritize ethical considerations in light of widespread international condemnation of non-consensual genital surgery as a violation of human rights, and possibly a form of medical torture, by organizations including the United Nations (16-18; also see attachment "AIC UN Special Rapporteur for Health").
Based on these considerations, Advocates for Informed Choice recommends that Medicaid provide routine funding of expectant management for intersex/DSD that promotes health and wellbeing, including early supportive interventions for families, such as education and psychosocial and peer support starting at the time of diagnosis (11). Routine reimbursement of puberty blockers to postpone puberty is urgently needed for children whose gender identity may be discordant with their originally assigned gender. These children also require flexible access to sex hormones. Gender-affirming surgery should be covered for adolescents and adults who can fully comprehend the risks and benefits.
Arlene B. Baratz MD
Chair, Medical and Research Policy Committee for Advocates for Informed Choice
1. Coleman E, Bockting W, Botzer M, Cohen-Kettenis P, DeCuypere G, Feldman J, et al. Standards of care for the health of transsexual, transgender, and gender-nonconforming people, version 7. International journal of transgenderism. 2011;13:165-232. doi: 10.1080/15532739.2011.700873.
2. Mouriquand P, Caldamone A, Malone P, Frank JD, Hoebeke P. The ESPU/SPU standpoint on the surgical management of Disorders of Sex Development (DSD). Journal of pediatric urology. 2014;10(1):8-10. doi: 10.1016/j.jpurol.2013.10.023. PubMed PMID: 24528671.
3. Barthold JS. Disorders of sex differentiation: a pediatric urologist's perspective of new terminology and recommendations. J Urol. 2011;185(2):393-400. doi: 10.1016/j.juro.2010.09.083. PubMed PMID: 21167531.
4. Lee PA, Houk CP, Ahmed SF, Hughes IA, International Consensus Conference on Intersex organized by the Lawson Wilkins Pediatric Endocrine S, the European Society for Paediatric E. Consensus statement on management of intersex disorders. International Consensus Conference on Intersex. Pediatrics. 2006;118(2):e488-500. doi: 10.1542/peds.2006-0738. PubMed PMID: 16882788.
5. Institute of Medicine (US) Committee on Lesbian G, Bisexual, and Transgender Health Issues and Research Gaps and Opportunities. The Health of Lesbian, Gay, Bisexual, and Transgender People: Building a Foundation for Better Understanding. Washington DC: National Academies Press (US); 2011.
6. NIH FY 2016-2020 Strategic Plan to Advance Research on the Health and Well-being of Sexual and Gender Minorities. http://edi.nih.gov/sites/default/files/EDI_Public_files/sgm-strategic-plan.pdf2015.
7. Pasterski V, Zucker KJ, Hindmarsh PC, Hughes IA, Acerini C, Spencer D, et al. Increased Cross-Gender Identification Independent of Gender Role Behavior in Girls with Congenital Adrenal Hyperplasia: Results from a Standardized Assessment of 4- to 11-Year-Old Children. Archives of sexual behavior. 2015;44(5):1363-75. doi: 10.1007/s10508-014-0385-0. PubMed PMID: 25239661.
8. Crouch NS, Liao LM, Woodhouse CR, Conway GS, Creighton SM. Sexual function and genital sensitivity following feminizing genitoplasty for congenital adrenal hyperplasia. J Urol. 2008;179(2):634-8. doi: 10.1016/j.juro.2007.09.079. PubMed PMID: 18082214.
9. Minto CL, Liao L-M, Woodhouse CRJ, Ransley PG, Creighton SM. The effect of clitoral surgery on sexual outcome in individuals who have intersex conditions with ambiguous genitalia: a cross-sectional study. The Lancet. 2003;361(9365):1252-7. doi: 10.1016/s0140-6736(03)12980-7.
10. Callens N, van der Zwan YG, Drop SL, Cools M, Beerendonk CM, Wolffenbuttel KP, et al. Do surgical interventions influence psychosexual and cosmetic outcomes in women with disorders of sex development? ISRN endocrinology. 2012;2012:276742. doi: 10.5402/2012/276742. PubMed PMID: 22462013; PubMed Central PMCID: PMC3313564.
11. Liao LM, Wood D, Creighton SM. Parental choice on normalising cosmetic genital surgery. Bmj. 2015;351:h5124. doi: 10.1136/bmj.h5124. PubMed PMID: 26416098.
12. Jevtovic-Todorovic V, Absalom AR, Blomgren K, Brambrink A, Crosby G, Culley DJ, et al. Anaesthetic neurotoxicity and neuroplasticity: an expert group report and statement based on the BJA Salzburg Seminar. Br J Anaesth. 2013;111(2):143-51. Epub 2013/06/01. doi: 10.1093/bja/aet177. PubMed PMID: 23722106; PubMed Central PMCID: PMCPmc3711392.
13. Rappaport BA, Suresh S, Hertz S, Evers AS, Orser BA. Anesthetic neurotoxicity clinical implications of animal models. The New England journal of medicine. 2015;372(9):796-7. doi: 10.1056/NEJMp1414786. PubMed PMID: 25714157.
14. Streuli JC, Vayena E, Cavicchia-Balmer Y, Huber J. Shaping parents: impact of contrasting professional counseling on parents' decision making for children with disorders of sex development. The journal of sexual medicine. 2013;10(8):1953-60. doi: 10.1111/jsm.12214. PubMed PMID: 23742202.
15. Kon AA. Ethical issues in decision-making for infants with disorders of sex development. Horm Metab Res. 2015;47(5):340-3. doi: 10.1055/s-0035-1547269. PubMed PMID: 25970711.
16. OHCR Oothcfhr. Opening remarks by Zeid Ra'ad Al Hussein, United Nations High Commissioner for Human Rights at the Expert meeting on ending human rights violations against intersex persons 2015 [cited 2015 11/01]. Available from: http://www.ohchr.org/EN/NewsEvents/Pages/DisplayNews.aspx?NewsID=16431&LangID=E2015.
17. Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. A/70/213: United Nations General Assembly; 2015 [updated 07/30/2015; cited 2015 11/01]. Available from: undocs.org/A/70/213.
18. UN Intersex Fact Sheet: United Nations Office of Human Rights High Commissioner; [cited 2015 11/01]. Available from: https://www.unfe.org/system/unfe-65-Intersex_Factsheet_ENGLISH.pdf.
Title: Senior Director of Policy
Organization: Whitman-Walker Health
December 28, 2015
James Rollins, MD, Director, Division of Items and Services
Linda Gousis, JD, Lead Analyst
Centers for Medicare and Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244
Re: National Coverage Analysis for Gender Dysphoria and Gender Reassignment Surgery, CAG-00446N
Dear Dr. Rollins and Ms. Gousis:
Whitman-Walker Health (Whitman-Walker or WWH) is pleased to offer these comments on the need for a National Coverage Determination (NCD) on Gender Dysphoria and Gender Reassignment Surgery, in response to the proceeding opened by CMS on December 3, 2015.
We commend CMS’s determination “to review the available evidence and conduct a … review to determine whether health outcomes are improved from treatment for Gender Dysphoria and Gender Reassignment Surgery.”1 As a health care center with a history of serving transgender patients, we strongly support the creation of an NCD that covers the full range of therapeutic – including surgical options to treat gender dysphoria.
Interest and Expertise of Whitman-Walker Health
Whitman-Walker is a Federally Qualified Health Center located in Washington, DC. Our mission is to be the highest quality, culturally-competent community health center serving greater Washington’s diverse urban community, with a special focus on LGBT individuals and families, persons living with HIV, and other individuals and families who face barriers to accessing care. We offer primary medical for all individuals, including those living with HIV; LGBT primary and specialty care, including transgender care; dental care; mental health care and addictions counseling and treatment; nurse care management; HIV education, prevention, and testing services; other community health services; and legal services. Our medical team includes internists, family medicine physicians, infectious disease specialists, physician assistants, and nurse practitioners; and our behavioral health providers include psychiatrists, licensed clinical social workers, and licensed professional counselors. In calendar year 2014, we provided health services to more than 14,700 distinct individuals. Transgender and gender nonconforming individuals comprise a substantial and growing part of our patient and client base: approximately 13% of our medical patients; 20% of persons receiving mental health services; 8% of those receiving substance abuse treatment services; and 6% of all those receiving any health services.
By implementing an integrated care model, we ensure that a range of client needs are identified and addressed and that service delivery is coordinated. Transgender persons utilize all WWH services, with a range of transition-related care provided by our medical and behavioral health providers, including hormone therapy, laser hair removal, and individual and group therapy. WWH also holds two “Trans* Peer Support Groups” specifically for individuals across the gender spectrum and in any stage of transitioning. The focus of the groups is to promote social support and wellbeing for transgender, gender non-conforming or gender queer adults, with topics including navigating transition, coming out, family and workplace issues, relationships, dating, and other issues. WWH also provides referrals for gender-affirming surgeries, and the documentation required to undergo such surgeries. In addition, we provide ongoing primary care and behavioral health services for many transgender patients after they have undergone surgery.
Whitman-Walker Health’s Legal Services Program also has extensive experience serving the transgender community in a variety of ways, including the monthly name and gender change clinic. We frequently assist transgender clients with discrimination or harassment claims in the workplace, at school, in housing, with government agencies, hospitals, and public accommodations and with public benefits navigation, consumer matters, estate planning, and immigration relief. In the 12 months ending October 31, 2015, legal services were provided to 507 transgender individuals - approximately 20% of our total legal clients.
Lack of adequate insurance coverage for their health care needs – including surgery – is a fundamental concern for our transgender patients and legal clients of every age, including the considerable number of our patients who are enrolled in Medicare. We are heartened by CMS’ commencement of this proceeding, and offer our considerable experience as providers of health care to almost 1,000 transgender patients every year, to support the issuance of a comprehensive NCD for surgical and other treatment of gender dysphoria.
The Health Benefits of Surgical and Other Treatments for Gender Dysphoria
Scientific research provides robust evidence of the benefits, and the medical necessity for many individuals, of a wide range of surgical as well as hormonal treatments to alleviate gender dysphoria. Much of the evidence was evaluated and endorsed in the May 30, 2014 decision of the HHS Departmental Appeals Board (Appellate Division). NCD 140.3, Transsexual Surgery, Docket No. A-13-87, Decision No. 2576, available at http://www.hhs.gov/dab/decisions/dabdecisions/dab2576.pdf. Additional evidence is compiled in the “Summary of Clinical Evidence for Gender Reassignment Surgeries,” submitted in this proceeding by the Transgender Medicine Model NCD Working Group. On the basis of this evidence, and extensive clinical experience of providers, leading health care professional associations have endorsed gender transition a wide range of surgeries and other treatments, including the American Medical Association, American Academy of Family Physicians, the Endocrine Society, American Psychiatric Association, American Psychological Association, and American College of Obstetricians and Gynecologists.
The extensive clinical experience of Whitman-Walker’s providers is consistent with the peer-reviewed studies and other published evidence and the conclusions of leading medical and mental health professional associations. Time and again, surgical as well as hormone replacement and mental health therapies have proved highly successful for our patients. The following are a few representative observations from our providers:
- A 46-year old African-American transgender man, living in poverty, unemployed and with an unstable housing situation, began hormone therapy at WWH in 2008. He began living “full time” as male beginning in 2009, but was unable to access chest reconstructive surgery because of financial barriers. This was especially anxiety-provoking and traumatic for him because he often had to access male homeless shelters and was constantly fearful of being “found out” because of his “female anatomy.” This patient was finally (after 5 years living as male) able to obtain chest reconstructive surgery through a change in DC Medicaid policy. He received his chest surgery in late 2014. After his surgery, he completed an educational program and is now employed and saving money for his own apartment.
- A 41-year old transgender woman of color presented at WWH with history of depression and PTSD. She engaged at WWH for hormone therapy, mental health services and primary care to address other physical health concerns. She gained access to surgery after DC Medicaid began coverage of gender-affirming surgeries, and the changes significantly improved her sense of well-being and confidence. Her improved mental health has resulted in a need for significantly fewer individual therapy appointments.
- A 27-year old Caucasian transgender female presented with major depression, intermittent suicidal ideation and PTSD. She sought breast augmentation to help her with continued depressive symptoms associated with gender dysphoria. This client lived in perpetual fear of being “clocked as trans.” She did not gain adequate breast growth through hormone therapy alone. She was finally approved for breast augmentation through DC Medicaid and underwent surgery in the fall of 2015. She was subsequently able to leave her psychotherapy group after a substantial increase in her self-confidence due in large part to the surgical results.
- A 32-year old Caucasian transgender woman presented with significant depressive symptoms, suicidal ideation and active alcohol abuse. She Joined a WWH psychotherapy group to explore gender transition, and subsequently commenced hormone therapy. Her depressive symptoms greatly subsided, and her alcohol abuse is in remission. She has come out to her family and friends and at work, and has otherwise successfully transitioned. She was able to move out of her psychotherapy group and to become a peer support facilitator to provide help and support to other transgender individuals who are early stages of their transition.
- A young transgender man came to WWH in a desperate situation. Due to family rejection and harassment at his low-paying job, he was acutely suicidal and close to being hospitalized on several occasions. With the help of his WWH therapist, he realized that he did not want to die, but wanted to live as his true self. He began HRT, received psychotherapy, attended a psychotherapy group for trans-identified young adults, and will soon be undergoing top surgery. The availability of this surgery has been instrumental in helping him find the will to live and the ability to thrive.
Perhaps the most comprehensive view of the benefits of the full range of treatments, including gender-affirming surgeries, is provided by our Behavioral Health Specialist/Medical Liaison and Peer Support Program Supervisor, Stacey Karpen, who is responsible for conducting psychological assessments for WWH patients seeking hormone replacement therapy and gender-confirming surgery. As explained in her accompanying Statement, the need for and benefits of gender-affirming surgeries and other therapies have been substantiated by the overwhelming majority of more than 100 assessments that Ms. Karpen has conducted for our patients.
As providers of care to a large transgender community, we understand that each patient has their own unique desires and needs in order to live their authentic selves and that there is not a singular path for treating gender dysphoria. There are many essential elements in the clinical arsenal to alleviate gender dysphoria and facilitating access to these treatments via insurance coverage is critical to successful patient care. The Transgender Medicine Model NCD Working Group’s proposed Model NCD, prepared by noted experts in the field of transgender care, is comprehensive and reflects current evidence and clinical experience, and Whitman-Walker is pleased to endorse it.
We believe it is important to emphasize that the procedures that individual patients may need to fully treat their gender dysphoria, and affirm their true gender, include facial feminization, breast reconstruction, body contouring, tracheal shave and laser hair removal – as well as breast augmentation, mastectomy/chest masculinization, hysterectomy/oophorectomy, metoidioplasty, phalloplasty and vaginoplasty. When appropriately substantiated, consistent with WPATH standards, none of these procedures should be excluded from coverage by being inappropriately labeled as “cosmetic”. Many of our transgender patients need some or many of these procedures not only to fully eliminate the gender dysphoria from which they have suffered, but also to avoid the mis-gendering, discrimination, harassment, violence and stigma from others, which continue to threaten their mental and physical well-being.
Thank you for this opportunity to submit comments in this very important proceeding. Please contact us through Daniel Bruner, Senior Director of Policy,
firstname.lastname@example.org, (202) 939-7628, if we can provide any additional information.
Sarah Henn, MD, MPH
Senior Director of Health Care Operations
Randy Pumphrey, D.Min., LPC, BBC
Senior Director of Behavioral Health
Daniel Bruner, JD, MPP
Senior Director of Policy
Statement of Stacey Karpen, LPC, NCC, Whitman-Walker Health
National Coverage Analysis for Gender Dysphoria and Gender Reassignment Surgery, CAG-00446N
December 28, 2015
I am a licensed professional counselor with an M.A. in Clinical Mental Health Counseling currently employed by Whitman Walker Health (WWH) as a Behavioral Health Specialist/Medical Liaison and Peer Support Program Supervisor. I am also a doctoral candidate in Counseling at George Washington University, with expected completion of this program in January 2016. Outside of WWH, I have conducted several presentations on cultural competency related to serving the LGBTQ population and run a small private practice specializing in working with transgender youth and adults.
In my role as Behavioral Health Specialist and Medical Liaison at WWH, I conduct psychological assessments for patients seeking hormone replacement therapy (HRT) and gender confirming surgery. During these evaluations I obtain a full mental health, psychosocial and psychiatric history in an effort to ascertain whether or not a diagnosis of Gender Dysphoria (DSM-5, 302.85, and ICD 10, F64.1) is substantiated. This assessment is aligned with the requirements of the World Professional Association of Transgender Health Standards of Care. In addition, I provide short-term and long-term psychotherapy to transgender clients.
I can state with absolute confidence that gender affirming medical and mental health care saves lives. It is an understatement to say that treating individuals with Gender Dysphoria does not only improve their quality of life: in fact, it enables them to live a life they deem worth living. At least 80-85% of the clients that I assess for HRT or for surgery have a history of suicidal ideation, and many have one or multiple past suicide attempts. Nearly all of my clients have experienced emotional, physical or sexual assault as a result of their gender identity. Major Depression and Anxiety disorders as result of the psychosocial challenges of living as a transgender person are incredibly prevalent. I rarely meet a trans-identified person who has not experienced anxiety or depression related symptoms, often at acute and life-impairing levels.
My clients have suffered embarrassment, humiliation, violence, and sheer indifference to their humanity simply because their authentic gender identity is incongruent with their gender assigned at birth. Yet, despite their varied challenges, my patients’ capacity for resilience is astounding. Despite living in a society that discriminates against them, these individuals courageously strive to live authentically.
I have assisted probably over 100 clients to access HRT or surgery. Throughout this process I have had the honor of bearing witness to my patients’ transitions into confident individuals, comfortable in their own skin. Levels of depression, anxiety, suicidal ideation, and low self-esteem diminish dramatically. Oftentimes I have found that clients with psychiatric diagnoses are able to stabilize and reduce psychiatric medications once their body becomes more congruent with their authentic gender identity.
About one year ago I began working with a young man who came to me in a desperate situation. He was acutely suicidal and there were several occasions in which I was close to hospitalizing him. His family rejected his trans identity and withdrew all emotional and financial support. He was working at a low-wage job with a boss who constantly harassed him (and encouraged other staff members to harass him) because of his gender identity. I can recall an interaction we had during one of our sessions in which he discussed his thoughts of suicide. I remember saying to him something to the effect of, “I don’t think you are telling me that you don’t want to live. I think you are telling me that you are tired of living like this. In truth, I think you desperately want to live, you just want to live and be accepted as your true self.” With tears in his eyes, he nodded his head in agreement.
Over the course of one year, this client began HRT, received psychotherapy, attended a psychotherapy group for trans identified young adults, and will soon be undergoing top surgery. He quit his job and spoke to his employer about his manager’s abuse. He began to build a chosen family of LGBTQ identified and supportive individuals. Ultimately, he found the will to live and has done everything in his power to live authentically. Without HRT and without the hope of surgery, I truly don’t believe that this this young man would have found the strength to continue living.
Gender affirming medical interventions are life-saving interventions that should be accessible to all. Surgeries such as breast augmentation, mastectomy/chest masculinization, hysterectomy/oophorectomy, metoidioplasty, phalloplasty and vaginoplasty have significantly improved patients’ quality of life; however, additional interventions such as facial feminization, breast reconstruction, body contouring, tracheal shave and laser hair removal are equally as important in the process of diminishing the incongruence and impairment associated with Gender Dysphoria. These medical interventions, though sometimes considered “cosmetic,” are vitally important to a person who is transitioning. Many of my post-surgery clients have expressed concern that without these smaller procedures they remain unable to be recognized as their authentic gender identity. Without access to this care, mis-gendering, discrimination, harassment, violence and stigma remain a perpetual concern for transgender clients. These procedures should be part of comprehensive coverage for transgender patients. Providing only some services and not others will not fully reduce the detrimental effects of Gender Dysphoria and mental health concerns will continue to plague this community.
Thank you for your consideration of this statement.
1 National Coverage Analysis (NCA) Tracking Sheet for Gender Dysphoria and Gender Reassignment Surgery (CAG-00446N), https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=282.
Comments of Whitman-Walker Health in CAG-00446N
Stacey Karpen, LPC, NCC
Title: Senior Health Program Planner
Organization: San Francisco Department of Public Health
December 31, 2015
Linda Gousis, J.D.
James Rollins, MD
The Centers for Medicare & Medicaid Services (CMS)
RE: CAG-00446N National Coverage Analysis for Gender Dysphoria and Gender Reassignment Surgery
Dear Ms. Gousis and Dr. Rollins,
Thank you for the opportunity to submit comments on the development of a National Coverage Determination (NCD) for Gender Reassignment Surgery. The San Francisco Department of Public Health (SFDPH) strongly supports this NDC endeavor and offers the information below based on our extensive experience providing transition-related surgeries and services.
Having long cared for persons across the Trans spectrum in our system of care, San Francisco became the first city in the United States to provide gender confirming surgery, at a time when Medicare did not deem the procedure medically necessary. Through our Transgender Health Services, we facilitate access to gender confirming surgeries and education and preparation services for transgender, transsexual, and gender non-conforming public health patients in San Francisco. We have three years of experience administering gender confirmation programs for Medicaid beneficiaries and people who do not have health insurance at the time of their surgery.
Our Transgender Health Services program has successfully completed ninety-seven surgeries since September 2013. Our experience mirrors the available peer-reviewed empirical research, which suggests that access to gender confirming surgery decreases gender dysphoria and may improve quality of life. Among the patients in our program, access to gender confirming surgery and other medically necessary care results in health improvement and other positive outcomes. Gender dysphoria, which is the clinical and emotional distress experienced when an individual's gender identity is different from their sex reported at birth, negatively impacts social and vocational functioning and self-esteem.
SFDPH Transgender Health Services offers transgender women access to breast feminization/augmentation and genital surgeries. Masculine spectrum surgeries include chest reconstruction and revisions, metiodioplasty and phalloplasty. All genital surgeries require hair removal from the graft sites prior to surgery, and we have also been able to help patients receive facial hair removal through our local public health plan.
The necessity of providing gender confirmation surgeries is evident in the gratitude expressed by our clients. Routinely, clients report a sense of happiness, empowerment, and completion. Some examples include:
"Thank you for my penis. Before chest surgery/double mastectomy and phalloplasty, daily activities like urinating and bathing would provoke an anxiety that infected every other facet of my life. Surgery access has allowed me to plan, and long for, a future."
"I'm ten times happier with my life."
"After surgery I felt more beautiful, more womanly, more complete, more positive."
"I experienced freedom and empowerment"
"I feel complete."
"Emotional turmoil and pain of being in the wrong body subsided which is amazing and awesome."
"Ifm so lucky to live in San Francisco where we have these surgeries."
When developing the Medicare National Coverage Determination on Gender Reassignment Surgery, we recommend that CMS consider the points enumerated below. These recommendations are grounded in our years of administering the Transgender Health Services program and lessons learned along the way.
Transgender people need to have access to medical and surgical interventions that decrease their gender dysphoria and assist them in functioning as their identified gender in all areas of life. The paradigm of providing transgender people with surgeries that were available for cisgender people is not clinically based, rather it is a civil rights strategy. Clinically, transgender women may need to have facial feminization surgeries or breast feminization procedures that have not historically been available to cisgender women. It is important for CMS to cover surgeries and treatments that permit transgender women to participate fully in life as women and that permit transgender men to participate fully as men. People who are genderqueer may also require surgical interventions to decrease their dysphoria.
All of the following medically necessary procedures should be covered:
- Facial Feminization Surgeries
- Vaginoplasty, labiaplasty, vulvoplasty
- Breast feminization/augmentation
- Revision surgeries when needed
- Hair removal from the face, neck, breasts, and genital region prior to gender confirmation surgeries.
- Chest reconstruction
- Metoidioplasty and scrotoplasty
- Phalloplasty, testicular implants, and erectile devices
- Urethral reconstruction including lengthening where indicated
Patient and provider education is critical. Transition can sometimes be a multi-year process, and both the clients and providers need adequate preparation. Each client is a unique individual and must be sufficiently supported to decide for themselves the personal cost and potential benefits of various surgical interventions.
Programs need to be comprehensive and multidisciplinary, and ongoing clinical case management pre- and post-surgery is vital. Successful surgeries are based on solid partnerships between the patient, the provider, and the care management team. SFDPH Transgender Health Services makes a significant effort to train provider teams to ensure a continuum of care for the client pre- and post-surgery.
Transgender people accessing public health care services are disproportionately affected by stigma and discrimination and are less well-resourced. Many patients cannot afford to pay for non-covered medical supplies or travel related to aftercare, and may need extra support due to isolation, poverty and medical/mental health issues. Patients may not have a home to go to, may not have family or friends to assist in their recovery, may lack the financial resources to purchase medical supplies that are not covered, and may need transportation assistance. These issues should be mitigated by care coordination and social programs. Clinical case management and follow-up are critically important.
Some surgeries require revisions and these revisions must also be covered by Medicare. The peer-reviewed literature suggests that unaddressed complications result in increased psychological distress. Barriers to revision surgery essentially prevent transgender persons from moving on with healthy, productive lives.
Patients and providers need assistance navigating the healthcare system and the insurance requirements. The administrative process for successful coverage approvals is cumbersome and confusing for both patients and providers. Billing and coding guidelines must be clearer and easy to follow. The uniform treatment of claims may decrease the need for appeals and reduce or even eliminate the distress caused by denials. Providers need additional support to properly and efficiently navigate the administrative challenges, which often add unnecessary barriers to care. When providers do not have clear paths forward for medically necessary treatments, patients experience unnecessary stress and an undue burden is placed on the system of care.
Gender reassignment eligibility requirements should mirror clinical treatment goals. The World Professional Association of Transgender Health (WPATH) Standards of Care outline the eligibility requirements for transgender-related medical and mental health services, and these Standards are central to the care operations in San Francisco. Genital surgery, for example, requires two letters from mental health professionals; and one letter is required for chest and breast surgery. One of the areas we are currently working to improve are the eligibility requirements for gender non-conforming and genderqueer people. These individuals may also need access to surgical interventions; however, the service eligibility requirements for people identified outside of a gender binary structure are often not as clear to providers as they are for transgender men and women.
In sum, the goals of medically necessary surgical interventions for transgender, transsexual, gender non-conforming, and genderqueer people are to decrease gender dysphoria and to increase the likelihood that
the person can more fully participate in society. An NCD on Gender Reassignment Surgery must cover all related medically necessary procedures; surgical eligibility requirements should mirror clinical treatment goals; patients should be well-prepared for surgery and educated about the risks and potential benefits; and patients should also receive ongoing clinical case management before surgery and throughout the recovery period.
The San Francisco Department of Public Health appreciates the opportunity to share our experiences and to offer the comments above. As CMS develops this highly important NCD, which has the capacity to change many peoplefs lives for the better, we are happy to offer further assistance. If you have any questions or need clarifications, please contact Julie Graham, Interim Director of SFDPH Transgender Health Services, at email@example.com or (415) 642-4519.
Barbara A. Garcia
Director of Health
San Francisco Department of Public Health