The Mount Sinai Patient-Centered Preoperative Criteria Meant to Optimize Outcomes Are Less of a Barrier to Care Than WPATH SOC 7 Criteria Before Transgender-Specific Surgery

Abstract

Objectives: With expanding coverage of gender-affirming care in the United States, many insurers default to the World Professional Association for Transgender Health (WPATH) Standards of Care 7 (SOC 7) to establish eligibility requirements for surgery coverage. Informed by bariatric and transplant surgery evaluation models, the Mount Sinai Center for Transgender Medicine and Surgery (CTMS) developed patient-centered criteria to assess readiness for surgery, focusing on concerns that could impair recovery. To make recommendations for the next version of the WPATH SOC, SOC 8, we compared Mount Sinai patient-centered surgical readiness criteria with the WPATH SOC 7 criteria.

Methods: Data were extracted from a deidentified data set developed as part the quality dashboard for CTMS. The data set included all patients seeking vaginoplasty who were evaluated by a single mental health provider, from July 2016 through August 2018, and who completed the full CTMS assessment. The number of patients eligible for surgery based on the Mount Sinai CTMS criteria was compared with the number of patients eligible for surgery according to WPATH SOC 7 criteria.

Results: Of 139 patients identified, 63 (45%) were ready for surgery immediately based on the Mount Sinai patient-centered model. By contrast, only 21 (15%) out of the 139 met criteria for surgery based on WPATH SOC 7. Fifty patients (40%) were ready for surgery as per Mount Sinai patient-centered readiness review but not WPATH criteria.

Conclusion: An assessment designed to better prepare patients for surgery may also result in fewer barriers to care than existing criteria used by insurance companies in the United States.

Introduction

Transgender or gender nonbinary (TGNB) are adjectives that generally describe incongruence between an individual's sex recorded at birth and that individual's gender identity. An estimated 0.6% of the U.S. population identifies as TGNB.¹ With greater recognition of the durable biological underpinning to gender identity, there has been greater appreciation for the medical treatment needed for transgender individuals who seek to alter aspects of anatomy to align with gender identity for the health benefit for those individuals.^2–6

Despite increased visibility of transgender individuals, there has been little investigation into utilization of TGNB-related health services over time since the 2015 U.S. Transgender Survey reported that over 25% of TGNB individuals had undergone one or more gender-affirming surgeries.⁷ More recent research has suggested that the number of gender-affirming surgeries is increasing annually and will continue to rise.⁸ If the incidence of TGNB is stable, increasing numbers might reflect increased access to TGNB-related health services.^9,10

TGNB patients face multiple barriers to quality health care.¹¹ Barriers to health care include those that are direct such as economic instability, unemployment, violence, and lack of health insurance^7,11–16 along with those that are indirect such as the scarcity of knowledgeable health care providers.^17–26 Despite several TGNB clinical practice guidelines,^8,27–29 the paucity of qualified clinicians continues to represent the greatest barrier reported by individuals.^{11,12,14,16–19}

Historically, transgender individuals have been obligated to go to significant lengths to prove gender identity and thus gain consent for transgender medical interventions^28–35 with greater effort required for gender-affirming surgeries such as vaginoplasty, phalloplasty, or breast/chest surgery. The first criteria for genital surgery were published in 1969³⁶ establishing a formula focused on the evaluation of the patient by a mental health specialist to substantiate evidence of gender dysphoria. Criteria also included social transition, treatment with hormone therapy for a certain period of time, lifestyle plans which involved a narrow definition of physical appearance, and a commitment to either celibacy or heterosexual sexual activity.³⁶ The criteria were revised by the World Professional Association for Transgender Health (WPATH, formerly called the Harry Benjamin International Gender Dysphoria Association, HBIGDA) in 1979, 1980, 1981, 1990, 1998, 2001, and 2011 (the latter as the WPATH Standards of Care, SOC 7).

The WPATH SOC 7 are often the default standard of care for the medical and surgical treatment of TGNB patients in North America and Europe. Over time, the WPATH criteria have become less conservative, removing eligibility requirements for psychotherapy, narrow gender presentation, sexual activity, the length of time recommended for hormone therapy, and living in the gender role.⁸

With state, federal, and national regulations shifted toward ensuring coverage of gender-affirming care,^37–40 many countries' national payers and United States insurers default to the WPATH SOC as guidelines to establish eligibility requirements for surgery coverage.^41–45 The strictest of these guidelines are for genital surgeries (vaginoplasty, vulvoplasty, phalloplasty, and metoidioplasty). Vaginoplasty has a significant recovery period as well as life-long changes to health (vaginal dilation) to ensure good outcomes from the surgery. The current SOC 7 guidelines do not mention assessment for adequate resources for recovery, and social support in relation to vaginoplasty outcomes in transgender people is largely unstudied.

The Mount Sinai Center for Transgender Medicine and Surgery (CTMS) opened in 2016 and has performed over 1200 transgender-specific surgeries, over 300 of which are vaginoplasty. Informed by bariatric surgery or transplant evaluation models (see Methods section), the Mount Sinai CTMS developed patient-centered criteria to assess readiness and optimization for surgery with focus on concerns that may impair recovery. The purpose of this study was to compare Mount Sinai patient-centered surgical readiness criteria to WPATH SOC 7 criteria for vaginoplasty to contribute to the advance of WPATH standards to be more patient centered.

Methods

Data set characteristics

Data were extracted from a deidentified data set developed as part of the quality dashboard for the CTMS at Mount Sinai. The data set included all patients seeking vaginoplasty who were evaluated by a single mental health provider, from July 2016 through August 2018, and who completed the full CTMS assessment.

The number of patients deemed prepared for surgery based on the Mount Sinai CTMS criteria (with medical, mental health, and social work input) was compared with the number of patients who would be eligible and cleared for surgery according to the WPATH SOC 7 alone after one contact with each provider (medical, mental health, and social work).

Additionally, the number of patients who met WPATH SOC 7 criteria but who were not prepared for surgery by the CTMS criteria was compared with the number of patients who did not meet WPATH SOC 7 while meeting the Mount Sinai CTMS criteria.

WPATH and Mount Sinai surgical screening requirements for transgender individuals

According to WPATH SOC 7, referral for transgender-specific surgical treatment can be initiated with a letter of support (or two, depending on the type of surgery) from a qualified mental health professional (Table 1).⁸ The specific qualifications for the mental health professionals are not defined in the WPATH SOC 7. Many define licensed mental health provider as having one or more of the following credentials (LCSW, MD/DO psychiatrist, Phd, PsyD, PMH-NP, PA, and any masters level or above counseling degrees).

Table 1.

Differences Between WPATH SOC 7 and Mount Sinai Gender Affirming Surgical Readiness Criteria

WPATH SOC 7	Mount Sinai CTMS
Medical	Medical
Letter of support from the patient's hormone provider confirming hormone regimen and length of time on hormone therapy (see below)a	The medical screen is performed by NP, PA or MD providers and consists of the following:
	If HIV positive, CD4>300 and undetectable viral load
Twelve continuous months of hormone therapy as appropriate to the patient's gender goals (unless the patient has a medical contraindication or is otherwise unable or unwilling to take hormones)	Body mass index <33
	If hepatitis B and/or C positive, undetectable viral load
	Hemoglobin A1c <8% or no history of diabetes
“No other active medical issues”	Serum nicotine 0 ng/mL, serum cotinine <30 ng/mL
Age of majority in a given country	No other active medical issues that would preclude surgery
	Specialty clearance if needed (e.g., neurology for history of seizure)
Mental health	Mental health
Persistent, well-documented gender dysphoria	The mental health screen is done by PhD, PsyD, or MD providers and consists of the following:
Psychiatric symptoms are “well controlled”	Confirmation of gender dysphoria/gender incongruence
Capacity to consent to vaginoplasty
Twelve continuous months of living in a gender role that is congruent with their gender identity. Although not an explicit criterion, it is recommended that these patients also have regular visits with a mental health or other medical professional.	No current psychiatric symptoms (severe depression, eating disorder, agoraphobia, psychosis, etc.) that would impair recovery
	Impaired recovery definition: inability to make follow-up appointments or follow aftercare instructions (which includes vaginal dilation at recommended schedule along with limitations to movement)
Two letters of support from mental health providers (see below)
	Capacity to consent to the procedure requested
	Collateral information from any treating mental health providers if patient reports relevant symptoms
	No suicide attempt in the last 6 months
	No self-harm in the last 6 months
	No psychiatric hospitalization in the last 6 months
	Urine toxicology negative for all but cannabis or prescribed medications
Social work	Social work
No criteria	Stable housing with adequate bathroom facilities
	Ability to stay within 90-minute drive of postoperative care offices for 4 weeks following surgery
	Ability to arrange for a caretaker for 4 weeks postoperatively.

^aThe WPATH SOC 7 recommended content of mental health letters of support for gender-affirming surgery is as follows:

1. The client's general identifying characteristics.

2. Results of the client's psychosocial assessment, including any psychiatric diagnoses.

3. The duration of the mental health professional's relationship with the client, including the type of evaluation and therapy or counseling to date.

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.

5. A statement about the fact that informed consent has been obtained from the patient.

6. A statement that the mental health professional is available for coordination of care and welcomes a phone call to establish this. For providers working within a multidisciplinary specialty team, a letter may not be necessary, rather, the assessment and recommendation can be documented in the patient's chart.⁸

CTMS, Center for Transgender Medicine and Surgery; WPATH SOC, World Professional Association for Transgender Health Standards of Care.

For our evaluation based on SOC 7 criteria, we included the above degrees with the following exclusions: mental health providers with lower than masters level training, unlicensed mental health providers of any type, NPs and PAs without mental health credentials, physicians who were not psychiatrists, or mental health providers who were still in training without a cosignature from their licensed supervisor. This decision was informed by mental health provider credentials insurance companies would accept.⁴⁵ Two letters from qualified mental health professionals who have independently assessed the patient are suggested for gonadal and genital surgery (i.e., hysterectomy/salpingo-oophorectomy, orchiectomy, genital reconstructive surgeries).

The Endocrine Society released its own guidelines for pursuing surgery.²⁷ This includes establishing that the patient is seeking vaginoplasty as a “medical necessity.” While not explicitly stated in the WPATH SOC, most insurance companies also require a “letter of medical necessity”⁴² from the patient's treating hormone prescriber that is in agreement with the mental health letters of support.

The Mount Sinai surgical screening process involves assessment in three categories: medical, mental health, and social work (Table 1). The Mount Sinai CTMS patient-centered approach includes writing letters of support/medical necessity for patients we assess for third party payers to approve payment for surgery. This not only gives patients quick access to mental health, medical, and social services when needed, but also streamlines letter writing and updating. Additionally, finding two mental health providers to do independent evaluations is time consuming, expensive, and difficult given the dearth of qualified mental health providers nationally.^46,47 Our evaluations/letters are part of our presurgical package and letters may be sent to other surgical offices at the patient's request. For our analysis, patients who otherwise met WPATH SOC 7 criteria, received one letter of support from the CTMS mental health provider doing the assessment. Patients whose hormone prescriber was the same person doing the presurgical evaluation (i.e., people who were at our clinic for primary care and now seeking surgery), who otherwise met WPATH SOC 7, received a letter of support from that hormone prescriber. These letters of support were used to satisfy third payer requirements to cover surgery and were not part of the CTMS assessment.

Differences between WPATH SOC 7 and CTMS requirements

Medical requirements for the Mount Sinai CTMS program are more specific than for the SOC 7 phrasing “no active medical issues” (Table 1). Included in the SOC 7 medical requirements is a letter of support from the patient's hormone prescriber, which is often an insurance mandate based on SOC 7 criteria. By specifying the medical criteria to include a body mass index cutoff, well-controlled HIV, and cessation of nicotine, we can better prepare patients for what will be necessary before a surgeon operating. The Mount Sinai criteria also remove the 12-month continuous hormone therapy requirement for vaginoplasty, which complicates matters for people who have received hormone therapy from nonmedical providers.

The difference between the SOC 7 and Mount Sinai mental health guidelines places the focus of assessment on surgical readiness rather than gender identity confirmation. Instead of referencing “well controlled” psychiatric symptoms, at Mount Sinai, psychiatric stability recommendations are based on events that can be measured so patient goals can be reasonably set. First, the phrase “well controlled” psychiatric symptoms is too broad in interpretation, which can allow mental health providers to keep patients in limbo indefinitely. Second, it does not establish clear guidelines for mental health providers who do not have thorough training in what surgical recovery entails (e.g., a patient who is at very high risk for repeat psychiatric hospitalization might not be allowed vaginal dilators as an inpatient if hospitalized during the acute vaginoplasty recovery period).

For the Mount Sinai assessment, 12 months of full-time social transition is removed. We found this criterion impractical for people exposed to discrimination at work or other areas of life. Capacity assessment remains the same in both criteria. Gender Dysphoria/Incongruence is based on patient report. A urine toxicology is also done to screen for substance use, which can complicate recovery either due to direct action of the substance or due to inability to follow postoperative plans. When needed, Mount Sinai refers patients to substance use treatment at our institution or in the community. The most significant deletion from the Mount Sinai criteria is the removal of the requirement of two independent psychiatric evaluations which places significant undue burden on patients.

An internal social work evaluation is part of the Mount Sinai process, but is entirely absent from the WPATH SOC 7. The evaluation has three items which are substantive for a patient to recover well from vaginoplasty: (1) Stable housing with adequate private bathroom and food preparation/kitchen facilities. (2) Residence (at least temporary) within 90 min of postoperative care offices for ∼4 weeks after surgery to ensure adequate postoperative follow-up by the surgical team. (3) Ability to arrange for a caretaker for the 4 weeks after surgery date to assist with activities of daily living that are severely curtailed during the acute recovery period (mobility, ability to cook or get food, ability to wash and get to bathroom). The patient also must provide a reasonable plan for safe transport to and from follow-up appointments. This includes identifying someone to ride with them and the ability to navigate necessary stairs.

Results

Demographics

The total number of patients' data collected from the dashboard on initial assessment was 195. After excluding patients who did not complete full assessment (laboratory work, and all three assessments) and patients whose initial evaluation was not done by the single mental health provider (e.g., evaluation by a trainee or a different mental health provider), the number of patients included was 139. The variables assessed were “ready” or “not yet ready” for surgery/surgical referral if they satisfied all criteria of the WPATH SOC 7 and “ready” or “not yet ready” based on the Mount Sinai patient-centered review. Patients failing to satisfy any one or more criteria of WPATH SOC 7 or Mount Sinai patient-centered review were deemed “not yet ready” for surgical referral based on those criteria.

More patients were ready for surgery as per the Mount Sinai CTMS criteria than per SOC 7

Of the 139 patients profiled, 63 (45%) were deemed ready for surgery immediately based on the Mount Sinai CTMS patient-centered model. By contrast, only 21 (15%) out of the 139 met criteria based on WPATH SOC 7. Thirteen (9.3%) met criteria for both assessments. Eight (5.7%) met criteria for WPATH but not CTMS patient-centered readiness. Fifty (40%) were deemed ready as per Mount Sinai patient-centered readiness review but not WPATH criteria (Table 2).

Table 2.

Number and Percent of Patients Presenting for Gender-Affirming Surgery Deemed Ready on Initial Visit Based on WPATH SOC 7 Criteria Versus Mount Sinai Criteria

Criteria	Patients ready	Patients not yet ready	Percent ready
Total patients 139	n/a	n/a	n/a
Mount Sinai criteria only	63	76	45.3%
WPATH SO7 criteria only	21	118	15.1%
Mount Sinai and SOC 7 criteria both satisfied	13	126	9.3%
Mount Sinai satisfied but not SOC 7	50	89	36.0%
SOC 7 satisfied but not Mount Sinai	8	131	6.0%

Discussion

To our knowledge this is the first study to compare patient-centered surgical readiness criteria to WPATH SOC 7 criteria using patient data. These results show that an assessment that is designed to better prepare patients for surgery can also result in fewer barriers to care than the existing criteria used by insurance companies.

The WPATH SOC for the Health of Transsexual, Transgender, and Gender Nonconforming People, seventh edition, are often considered the standard of care for TGNB people throughout the world. As an unintentional consequence, WPATH criteria have become default criteria by which U.S. insurance companies and some national health care payors in other countries approve or deny access to coverage for transgender-specific surgery.^41–45

Ethical medical treatment requires both the medical provider and the patient to agree to a treatment plan with achievable goals. For transgender-specific surgeries, the process has resulted in patients exerting significant effort to demonstrate gender identity to gain consent for treatment from a provider.³¹

The data presented show that not only do the WPATH criteria create a barrier to care when compared with a patient-centered multidisciplinary team, they also miss the opportunity to identify critically important psychosocial factors such as adequate housing and social support necessary for successful recovery, which are captured in our social work evaluation.

By contrast, bariatric^48,49 and transplant^50–53 surgeries, which both have extended recovery times along with requiring significant patient participation postoperatively (strict adherence to diet and antirejection medications), are organized around a multidisciplinary treatment center model. The model is designed to ensure that patients are prepared for surgery and have access to necessary treatment professionals.

Limitations

The referenced data set did not include patient outcomes linked to the readiness criteria. This represents a major limitation to this study. While our readiness criteria are meant to improve outcomes, confirmation of such effect remains for follow-up study.

We only tracked vaginoplasty. Vaginoplasty was chosen because the number of patients seeking vaginoplasty was greater than for other genital surgeries and the numbers permitted more confident analysis. Also, unlike genital surgeries, we do not have specific presurgical requirements for chest surgeries or facial feminization surgeries because those surgeries require less-extensive follow-up and carry less risk of complication. We only provide support and letters for these surgical categories when requested by payers or by providers.

Future directions

The limitations above call for further investigations of our data at Mount Sinai. Further studies will be needed to elucidate reasons for delay in surgery. There is also need to track patients to determine how long and for what reasons surgery is delayed. Finally, we will need to tie the Mount Sinai criteria to improved surgical outcomes.

Conclusion

We propose that some criteria for transgender surgical readiness be discarded both by WPATH in its upcoming eighth revision to its SOC along with commercial and government payors for medical services. For example, necessitating two independent psychiatric evaluations places an undue burden on transgender patients seeking surgery without providing a significant benefit when compared with a comprehensive care team model. In addition, the SOC 7 criteria ignore important psychosocial concerns (like stable housing and caregiving) to ensure success of the surgery and reduce complications. Surgical readiness criteria need to be based on good surgical outcomes. Thus, our team believes future criteria should remove gender identity verification and focus on outcome-oriented surgical readiness.

Abbreviations Used

CTMS

Center for Transgender Medicine and Surgery

HBIGDA

Harry Benjamin International Gender Dysphoria Association

SOC 7

Standards of Care 7

TGNB

Transgender or gender nonbinary

WPATH

World Professional Association for Transgender Health

Author Disclosure Statement

No competing financial interests exist.

Funding Information

No external funding was provided for this study.

Cite this article as: Lichtenstein M, Stein L, Connolly E, Goldstein ZG, Martinson T, Tiersten L, Shin SJ, Pang JH, Safer JD (2020) The Mount Sinai patient-centered preoperative criteria meant to optimize outcomes are less of a barrier to care than WPATH SOC 7 criteria before transgender-specific surgery, Transgender Health 5:3, 166–172, DOI: 10.1089/trgh.2019.0066.