Gender Dysphoria and Gender Reassignment Surgery

Tamara Syrek Jensen, J.D.
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard C1-14-15
Baltimore, MD 21244-1850

Dear Ms. Syrek Jensen,

We are writing to comment on the proposed decision regarding whether the Centers for Medicare & Medicaid Services (CMS) should issue a new National Coverage Determination (NCD) regarding gender reassignment surgery (GRS). Like you, we believe that all Medicare beneficiaries, including transgender individuals, should have access to high-quality coverage and care, and we appreciate your attention to this issue.

The proposed decision memo, in seeking to answer the question of whether there is sufficient evidence to conclude that GRS improves health outcomes for Medicare beneficiaries with gender dysphoria, asserts that the evidence is inadequate to support this conclusion. We acknowledge that a new NCD for GRS may not be warranted at this time, given that NCDs are relatively rare for Medicare procedures. It is also the case that widespread coverage exclusions regarding this care, many of which were lifted only recently, have limited the extent of research regarding the full scope of surgical procedures that may be medically necessary as part of gender transition.

However, we have grave concerns regarding flaws in the analysis that CMS cites to support its proposed decision¹ and the degree to which that decision could seriously undermine access to coverage for medically necessary health care services for transgender Medicare beneficiaries and other transgender individuals. We therefore respectfully urge you to revise the decision to clarify that Medicare coverage for GRS is available in appropriate cases and to ensure that the decision does not conflict with recent advances in transgender health, including the 2014 decision by the U.S. Department of Health and Human Services (HHS) Departmental Appeals Board overturning Medicare's ban on coverage for GRS.

Specifically, in light of the available evidence and the consensus of major medical associations regarding transition-related care, we believe the final decision must include the following points:

• The established medical consensus is that GRS is a safe, effective, and medically necessary treatment for many individuals with gender dysphoria, and for some individuals with severe dysphoria, it is the only effective treatment.
• Previous HHS findings support this consensus and indicate that the Standards of Care maintained by the World Professional Association for Transgender Health can satisfy Medicare's "reasonable and necessary" criterion for determining GRS coverage on a case-by-case basis.
• Medicare does cover transition-related care, including GRS in appropriate cases, and CMS's decision to not issue an NCD at this time must not be interpreted to the contrary or used in any way to inappropriately restrict access to coverage for transgender Medicare beneficiaries or other transgender individuals.
• Other legal standards beyond the NCD process-particularly the nondiscrimination protections codified in Section 1557 of the Affordable Care Act-also apply to Medicare coverage for GRS and other care related to gender transition.
• More research is needed on the health care needs of transgender individuals, but a Medicare coverage protocol that supports "coverage with evidence development" will not be issued at this time.

Below we discuss each of these points in more detail.

A transgender person is an individual whose gender identity or expression is different from the sex they were assigned at birth. According to 2016 estimates, there are at least 1.4 million transgender people living in the United States.² Like anyone, transgender individuals need preventive care to stay healthy and acute care when they become sick. Unfortunately, transgender individuals frequently face barriers to quality health care, such as harassment in health care settings, substandard care, and outright refusals of care.³ As a result of these barriers and other forms of discrimination, the transgender population as a whole experiences significant health disparities that include high incidence of HIV infection, elevated tobacco and other substance use, frequent exposure to abuse and violence, and a prevalence of suicidal ideation almost nine times higher than among the non-transgender population.⁴

Many transgender people need medical treatment to help them physically transition from their assigned birth sex to the sex with which they identify. The medical diagnosis that is frequently associated with a need for this treatment is "gender dysphoria," which refers to the clinically significant distress experienced by transgender individuals as a result of a profound misalignment between their gender identity and their assigned sex at birth. Gender dysphoria is described in the fifth edition of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and is recognized as a serious medical condition by the World Health Organization⁵ and every U.S. court that has considered the question.⁶ According to the standards of care maintained by the World Professional Association for Transgender Health (WPATH), treatment for gender dysphoria may include gender reassignment surgeries, hormone therapy, and mental health counselling, though the WPATH standards emphasize that treatment must be individualized for each patient on the basis of their clinical history and the judgment of their health care provider.⁷ Major medical associations-including the American Medical Association, the American Psychological Association, the American Psychiatric Association, the American Academy of Family Physicians, the Endocrine Society, and the American Congress of Obstetricians and Gynecologists, among others-agree that treatment for gender dysphoria is medically necessary.⁸

In a 2008 resolution, for example, the American Medical Association affirmed that mental health counselling, hormone therapy, and GRS are effective, safe, and medically necessary treatments for individuals diagnosed with gender dysphoria.⁹ The resolution further emphasizes that, without appropriate medical treatment, gender dysphoria can have consequences that include "clinically significant psychological distress, dysfunction, debilitating depression and, for some people without access to appropriate medical care and treatment, suicidality and death."¹⁰ As such, access to treatment for gender dysphoria, including GRS, is frequently a matter of life or death for transgender individuals.

Previous findings from the HHS Departmental Appeals Board (DAB) have already determined that a widespread medical consensus has established GRS as a "reasonable and necessary" treatment for gender dysphoria in appropriate cases.

In May 2014 the DAB invalidated NCD 140.3, which denied Medicare coverage of all "transsexual surgery," on the grounds that it was based on an outdated record from 1981 that was not complete or adequate to support the determination that transsexual surgery had not been shown to be effective.¹¹ In its ruling, the DAB cited expert testimony stating that "there are numerous long-term follow-up studies on surgical treatment demonstrating that surgeries are effective and have low complication rates,"¹² and noted that CMS did not challenge this testimony.¹³

The ruling also stated that, contrary to the NCD's assertion that GRS is "experimental" and "controversial," current evidence "indicates a consensus among researchers and mainstream medical organizations that transsexual surgery is an effective, safe and medically necessary treatment for transsexualism."¹⁴ The DAB noted that CMS guidance to contractors indicates that such a consensus may be sufficient to establish that a particular treatment is reasonable and necessary for purposes of Medicare coverage: "While the guidance states a 'preference' for '[p]ublished authoritative evidence derived from definitive randomized clinical trials or other definitive studies...,' it also includes as evidence meeting that standard, '[g]eneral acceptance by the medical community (standard of practice), as supported by sound medical evidence...'"¹⁵ According to the ruling, "[r]egardless of whether the new evidence here meets the first option for meeting the evidentiary standard set forth in the guidance (and CMS does not assert that it does not), it clearly meets the second option."¹⁶

In January 2016 the HHS Medicare Appeals Council ("the Council"), which is part of the DAB, issued a ruling that a Medicare Advantage plan's decision to deny coverage for GRS to a transgender Medicare beneficiary did not comport with Medicare's "reasonable and necessary" criterion.¹⁷ In its ruling, the Council echoed the 2014 DAB ruling in noting that the WPATH Standards of Care have "attained widespread acceptance" and emphasized that both the plan and the enrollee's physicians had recognized the "authority" of the WPATH Standards.¹⁸ The Council therefore concluded that these standards are "reasonable guidelines to determine medical necessity in this case"¹⁹ and found that, inasmuch as the enrollee "satisfies all of the WPATH clinical requirements for gender reassignment surgery...the requested vaginoplasty is medically reasonable and necessary for treatment of this enrollee's gender dysphoria under Section 1862(a)(1)(A) of the [Social Security] Act and is covered under existing CMS guidance."²⁰

Though this case involved only one individual, the Council expressly framed its ruling as an example of how it will adjudicate claims for GRS on a case-by-case basis in the absence of an NCD.²¹ Furthermore, inasmuch as the Council's ruling in this case constitutes a statement of HHS's opinion on the "widespread acceptance" of the WPATH Standards and the degree to which its guidelines for GRS can satisfy Medicare's "reasonable and necessary" test, this ruling and its approach to the WPATH Standards deserve significant deference. We therefore strongly urge CMS to state in the decision or in other guidance to Medicare contractors, as well as to Medicare Advantage plans and Medicare providers, that previous HHS findings on this issue indicate that the WPATH Standards of Care are reasonable guidelines to use in determining medical necessity and coverage for GRS on a case-by-case basis.

We are concerned that the proposed decision adopts an unnecessarily broad scope that could be read as a statement that Medicare does not cover GRS procedures for the treatment of gender dysphoria. Such an interpretation would be out of step with the previous HHS findings that GRS is "reasonable and necessary" in appropriate cases, and it will also negatively affect the health and wellbeing of transgender Medicare beneficiaries.

The proposed decision states that "CMS evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service is reasonable and necessary." We do not believe that this is an appropriate framing of the question in light of the DAB's existing ruling that the medical consensus-by itself-is sufficient to establish that GRS is reasonable and necessary. Rather, the only question before CMS is whether the evidence is of sufficient quality to support a finding that an NCD is the most appropriate means of providing GRS to Medicare recipients with gender dysphoria. We agree with the conclusion that an NCD is not warranted at this time and that "[t]he case-by-case model affords more flexibility to consider a particular individual's medical condition than is possible when the agency establishes a generally applicable rule."²² The scope of the proposed decision, however, substantially exceeds the specific question of whether an NCD is the most appropriate method of providing GRS to Medicare beneficiaries with gender dysphoria.

We have no doubt that CMS intended the broad scope of its analysis to help advance the field of transgender medicine by highlighting areas in need of additional research. However, in presenting a sweeping assessment of studies looking at the entire transgender population-and in drawing conclusions on the basis of an analysis that we believe has serious flaws-the proposed decision reads as a repudiation of GRS as an effective treatment for any transgender individual.

The breadth of this assessment is not required by the laws governing the NCD process. Under 42 U.S.C. 1395y(l)(3)(C) and guidance published at 78 Fed. Reg. 48164-01 (Aug. 7, 2013), a final decision memo must include only (a) summary of public comments and response to those comments, and (b) the scientific basis of CMS's coverage determination. There is thus no requirement for the decision to include any information or analysis that is not directly relevant to explaining the "scientific basis" for CMS's ultimate decision. In fact, including extraneous information could be actively misleading by giving the impression that the extraneous information also informed the "scientific basis" for the decision. If CMS determines that none of the studies for a given medical procedure provide sufficient analysis of the Medicare population, there is no basis for providing additional information, analysis, or critiques about other aspects of the relevant studies.

Similarly, there is no need to include information, analysis, or critiques about all studies relating to a medical condition if those studies do not strictly form the basis for evaluating the effectiveness and safety of the procedure in question. As such, we strongly urge you to limit the scope of the decision to noting that a preponderance of the available evidence specific to GRS does not include the Medicare population. In this situation, the logical conclusion is that an NCD is not warranted at this time because it is more appropriate to continue to assess the medical necessity of GRS procedures for Medicare beneficiaries on an individual basis, with guidance from the WPATH Standards or other relevant expert standards in the field of transgender medicine.

In addition to overgeneralizing from the lack of information available about the Medicare population, the proposed decision also fails to make clear distinctions between GRS and other treatments for gender dysphoria, such as hormone therapy. The proposed decision notes in passing merely that "the specific role for various surgical procedures is less well understood than the role of hormonal intervention," without any further clarification that the analysis applies only to surgical procedures. While we are aware that CMS intentionally focused this analysis on GRS, the lack of any other guidance from CMS about Medicare coverage for care related to gender transition makes it very likely that this proposed decision will be interpreted as the definitive statement of what Medicare does or does not cover. Given the decision's broad dismissal of the evidence related to GRS and its relative silence about any other aspects of transition-related care, we are deeply concerned that the decision will be used as evidence that Medicare does not cover any care related to gender transition-with predictable negative consequences not only for transgender Medicare beneficiaries but also those with coverage from other payers.

CMS indicates that the purpose of the proposed decision is to maintain the status quo regarding the availability of coverage for gender reassignment under Medicare. This perspective, however, fails to address the fact that the status quo for many transgender Medicare beneficiaries is a lack of coverage. A moderated online group for transgender Medicare beneficiaries with more than 2,600 members, for example, provides numerous examples of denials, confusion, and misinformation related to what Medicare covers for care related to gender transition:²³

• "I'm so upset with Medcare [sic] until I'm ready to just die, I found out that it will not pay for my Top surgery, not [sic] matter how much I try it seems that I'm always hitting this damn wall...I'm so tired of hitting that wall. So now I sit here crying and trying to think what to do, and I'm about to my witts [sic] end." (October 2015)
• "The surgeon replied to my request: Jaime in our insurance department called Medicare and this is what they said-National Coverage Determination is no longer valid, an appeal invalidated the coverage for transgender surgery. They have no idea when it might be reinstated. So with that being said there's no way we can submit this as gender reassignment. It will get denied and you will be responsible for everything." (November 2015)
• "Got a call from [hospital]. Surgeries are on hold. They have not been paid from four cases. They are in the process of trying to figure things out with Medicare. Not the best news for me." (December 2015)
• "The reason [for denial of bilateral mastectomy/chest reconstruction for a transgender man] is that the surgeons know that there is no National Coverage Determination, i.e. written policy on the part of Medicare. There hasn't been one since the ban was dropped...many surgeons are waiting for written policy." (April 2016)
• "I am disabled and on SSDI with Medicare. While I am fortunate to have had a career that puts me on the upper ranges of SSDI, and my wife works (17 years and she is just getting to $13 an hour) we don't have the kind of money we can throw at electrolysis for a surgical site on me. It's a prerequisite for surgery, there are no Medicare billing electrolysis technicians who I've found, and it's a lengthy process that requires in the $1000's to complete. If I don't find a way to get the funding for the electrolysis I very well will be shut off from obtaining the care I need. If I've got it bad, I can't imagine the unobtainable nightmare it must be for those fighting poverty." (June 2016)

One of the group's moderators provides the following summary of what he describes as common problems:²⁴

• Surgeons can't get preauthorization, so they won't schedule surgery. Even though original Medicare pays after the procedure, these surgeons won't take a chance on Medicare since there is nothing in writing to say Medicare will cover it. They will do it for other established surgeries, but surgeries related to gender reassignment are "taboo."
• Providers' offices say that Medicare does not cover transition-related services because they do not know about the 2014 DAB ruling rescinding NCD 140.3.
• Providers refuse to accept Medicare's low reimbursement rates.
• Providers do not know what codes they need to use to bill Medicare for GRS.
• Transgender Medicare beneficiaries call Medicare's call center and are regularly told the call center representatives can't say whether GRS is covered; call center representatives don't inform callers that procedures are being covered on a case-by-case basis.

The problem of ongoing denials of coverage for care related to gender transition is not restricted to Medicare. As of June 2016, for instance, 18 state Medicaid programs and 40 state-selected Essential Health Benefit (EHB) benchmark plans for 2017 still explicitly ban coverage for care related to gender transition.²⁵ This status quo is changing, but even in the short time the proposed decision has been public, numerous advocacy organizations have received reports of payers and regulators seizing on it as justification for attempts to limit access to transition-related care.²⁶ While we understand that CMS cannot be responsible for the actions of other payers and regulators, we strongly urge you to ensure that the decision is clearly restricted to the Medicare population and clarifies that coverage for GRS is available under Medicare on a case-by-case basis. We also encourage CMS to publish additional guidance for Medicare contractors, Medicare Advantage plans, Part D prescription drug plans, and providers, clarifying that physician services and prescription drugs related to gender transition-such as mental health counseling and hormone therapy-are broadly considered reasonable and necessary under Medicare guidelines.

As mentioned above, though NCD 140.3 was rescinded in 2014, many stakeholders appear to be unaware that Medicare does cover GRS on a case-by-case basis. Similarly, many stakeholders are unaware that Medicare covers services and medications such as mental health counselling and hormone therapy. We are concerned that the decision as currently proposed will encourage Medicare contractors, Medicare Advantage plans, Part D prescription drug plans, and Medicare providers to maintain or institute policies that both undermine the health and wellbeing of transgender individuals and violate federal nondiscrimination laws such as ACA Section 1557 by inappropriately denying access to transition-related care.

As you know, ACA Section 1557 prohibits any health program or entity receiving federal funds from discriminating on a variety of bases, including sex. HHS released a final rule in May 2016 clarifying that these sex protections extend to gender identity and sex stereotypes, meaning that they specifically include transgender individuals.²⁷ The final rule explicitly states that covered entities can no longer categorically exclude all services related to gender transition, and they cannot make coverage decisions in a manner that results in discrimination against a transgender individual-such as denying coverage for mental health services related to gender transition while covering them for depression, among many other examples. The final rule also requires health care providers to provide medically necessary health care services to transgender individuals, as long as those services are within the provider's scope of practice and are provided to non-transgender individuals. Section 1557 applies to all plans sold by any issuer who participates in federal health care programs such as Medicare or federally supported programs such as Medicaid. Covered entities that violate Section 1557's requirements are potentially subject to both administrative remedies and private lawsuits.

It is beyond the scope of the NCD process and the proposed decision memo to provide substantial guidance to contractors and other Medicare stakeholders on their legal obligations with regard to coverage for gender transition services under Section 1557. We believe, however, that CMS would do these stakeholders a disservice by failing to take the opportunity to reiterate that, in the absence of an NCD, Medicare contractors, Medicare Advantage plans, and Part D prescription drug plans must ensure that they are making coverage determinations in a nondiscriminatory manner. This involves eliminating categorical exclusions for transition-related care, as well as using medical necessity criteria that conform to the latest WPATH Standards of Care or other accepted standards in the field of transgender medicine and that do not inappropriately limit access to health care services for transgender individuals, including GRS and other services related to gender transition.

We appreciate CMS's support for more research regarding the treatment options available to transgender individuals with gender dysphoria. As you know, these treatment options are lifesaving for transgender individuals who need specific health care services to live authentic lives in bodies that reflect their true identity. We agree that more research is needed around the health care needs of transgender individuals and look forward to working with CMS and research entities such as the National Institutes of Health and the Patient-Centered Outcomes Research Institute to enhance the number and quality of studies in the field of transgender medicine.

In the meantime, however, we strongly caution against instituting a CED protocol for Medicare coverage of GRS. While we recognize that CMS policy allows use of the CED process in a wide range of situations,²⁸ a CED protocol would unnecessarily restrict access to care for transgender individuals. Outcomes research can be conducted without designating only a limited number of sites or providers where treatment can be received. Moreover, despite welcome advances such as the Section 1557 final rule, transgender individuals continue to face widespread discrimination, harassment, and even violence in aspects of everyday life as mundane as trying to access public restrooms. In the health care context, the long history of mistreatment of transgender patients at the hands of medical professionals leads many transgender individuals to be wary of the medical field and sometimes to avoid seeking health care entirely.²⁹ Potential study participants may thus have well-founded concerns about a policy that makes access to Medicare coverage for transition-related health care contingent on being enrolled in a formal medical research study. While a CED protocol would be a well-intentioned effort to advance the field of transgender medicine, in practice it would raise serious concerns for participants and would severely restrict the availability of lifesaving health care services for transgender individuals.

Thank you again for your dedication to the health and wellbeing of transgender individuals and for your invitation to provide public comment on the proposed NCD decision. We strongly support CMS in clarifying the circumstances under which GRS and other care related to gender transition is available under Medicare, and we appreciate your concern for doing so in a way that reflects the best current standards in the field, does not hinder access to medically necessary care in a discriminatory manner, and does not conflict with previous HHS findings on this matter. We look forward to continuing to work with you to ensure that the final decision is appropriate in scope and clear that coverage for GRS and other care related to gender transition is available under Medicare despite the lack of an NCD. Please do not hesitate to contact Kellan Baker at the Center for American Progress at kbaker@americanprogress.org or (805) 390-2309 with any questions or concerns about these comments.

Sincerely Yours,

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Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group, CCSQ
Centers for Medicare & Medicaid Services
7500 Security Blvd. C1-14-15
Baltimore, MD 21244

Dear Ms. Syrek-Jensen:

On behalf of the American College of Physicians (ACP), I am writing to submit this comment expressing ACP’s policy positions supporting medical, mental health and surgical treatment as beneficial and medically necessary care for individuals who meet the criteria for gender dysphoria.

The ACP is the largest medical specialty organization and the second-largest physician group in the United States. ACP members include 143,000 internal medicine physicians (internists), related subspecialists, and medical students. Internal medicine physicians are specialists who apply scientific knowledge and clinical expertise to the diagnosis, treatment, and compassionate care of adults across the spectrum from health to complex illness.

In 2015 ACP published a series of recommendations aiming to reduce health care disparities and achieve equity in the health care system for lesbian, gay, bisexual, and transgender (LGBT) individuals. Among these recommendations is the position that, “…public and private health benefit plans include comprehensive transgender health care services and provide all covered services to transgender persons as they would all other beneficiaries.”¹ We have adopted this policy after careful review of the scientific literature and research. Our reading of the research indicates that therapeutic treatment, including transition-related surgeries, are intended—and expected—to significantly restore areas of social, psychological and physical functioning that may have been impaired by gender dysphoria, and allow the body to function in a manner consistent with the patient’s innate gender identity.

The decision to undergo gender reassignment surgery is one made after careful consideration by the patient and their health care team which may include primary care physicians, endocrinologists, and mental health professionals. The World Professional Association for Transgender Health’s Standards of Care recognize that while patients’ needs differ and treatment decisions should be individualized, for some individuals “relief from gender dysphoria cannot be achieved without modification of their primary and/or secondary sex characteristics to establish greater congruence with their gender identity.”²

The cost of gender reassignment surgery and other transition-related health care services may be cost-prohibitive if the services are not covered by the patient’s health plan. Despite consensus among many professional medical organizations that transition-related medical services are medically necessary for many transgender individuals³, until recently transgender- and transition-related health care has been excluded from health plan benefits. In the absence of a National Coverage Decision on Gender Reassignment Surgery, we encourage CMS to reaffirm and make clear that Medicare coverage for transition-related surgeries would still be available on a case-by-case basis and explicitly state that nothing in its analysis should be construed as justification to deny coverage for transition-related surgeries in other contexts.

The American College of Physicians appreciates the opportunity to comment on the Proposed Decision Memorandum and looks forward to working with CMS on this important issue.

Sincerely,

/s/
Nitin S. Damle, MD, MS, FACP
President

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Tamara Syrek Jensen, J.D.
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard C1-14-15
Baltimore, MD 21244-1850

Dear Ms. Syrek Jensen,

As Subject Matter Experts in transgender medicine, we appreciate the opportunity to comment on CMS's Proposed Decision Memo CAG-00446N regarding gender reassignment surgery. The Proposed Decision Memo (henceforth abbreviated PDM) represents a major opportunity to reduce health disparities among the transgender population in the United States. However, the analysis as it stands includes many alarming and critical errors, which we believe present serious threats to a wide spectrum of transgender care not provided under Medicare.

We have conducted an extensive review of the PDM. In the attached documents, we include:

1. A summary of the methodological issues with the PDM, including examples from the CMS analysis.
2. A more detailed analysis of the papers undertaken to provide CMS, with a line by line analysis of the studies presented in Section VII of the PDM. For ease of comprehension, quotes from the PDM are in red. Quotes in black are from the article the PDM is analyzing or other cites sources.
3. A redlined document of the PDM itself, showing corrected errors and interpretations that consider the real context of transgender health and medicine. This document includes some comments from (2), so there is some overlap between documents. The redline and the detailed analysis was primarily written and edited by Drs. Nick Gorton and Kathy Hsiao, with input and coordination from many of the undersigned clinicians and researchers. For ease of reading, we have merged contributions from all parties into one document, so changes reflect only Dr. Nick Gorton's name. In this document we did not correct study descriptions found in the appendices, only in the main body of the PDM.

Because of the intensive nature of this work in a short time, we have taken care to present as accurate information as possible. However, we acknowledge that small errors may persist in our work. We are available to provide any additional information or clarification that would aid you as you consider revisions to the PDM.

Yours sincerely,
Nick Gorton, MD

Introduction
Thank you for the opportunity to comment on “Proposed Decision Memo for Gender Dysphoria and Gender Reassignment Surgery (CAG-00446N)”, hereafter we refer to as the PDM.

We have extensively reviewed the PDM. This is a summary of the major methodologic issues we have identified regarding the scientific literature quoted to support the PDM. While a more comprehensive critique of the each article is out of the scope of this summary comment, subsequent comments submitted by our Subject Matter Experts will provide that in greater detail.

We agree with the decision to not issue an NCD related to transgender care.

However, the PDM as it stands presents serious threats to a wide spectrum of transgender care not provided under Medicare.

As an example, one of the authors of this document is a medical expert on a case in New York to ensure coverage for SRS for recipients of the NY state Medicaid program. Even before the PDM has been finalized and less than a month after it was issued, this is being used to support the denial of care to transgender people.

This misuse is not based on the decision to not issue an NCD, but rather the PDM’s analysis is already being used as the basis of the litigation and bias. We have grave concerns that the PDM will be widely used to justify private and public insurance denials of care potentially undermining the substantial improvements in access to care that transgender people have gained in the past decade.

Our detailed evaluation of the PDM was performed by leading medical Subject Matter Experts in transgender medical and psychological care including an author of 2 of the papers used in the proposed CMS analysis.

Our evaluation has found critical flaws with the analysis of individual papers as well as the overall methodology. However, we feel that an improved document would be beneficial both as a higher quality systematic evidence-based review. This document could then be available as a resource for clinicians as well as avoiding the harms inherent in promulgating a flawed analysis that will be used well beyond the scope of Medicare recipients to deny medically necessary care to transgender individuals.

Methodological Concerns
“Evidence based medicine is defined as the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.”¹ It clearly takes a serious effort to understand and process the best available information in an honest, transparent and systematic fashion.² Reviews of the evidence are not equivalent and an inadequate review may do more harm than good. As stated above, we feel the potential harms from the PDM and the myriad flaws detailed below merit serious re-consideration by CMS.

The need to adhere to standards defining high quality reviews was emphasized in the creation of oversight organizations such as The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network which is an international initiative to promote “responsible reporting of health research”.³ The EQUATOR position statement describes the following practices that “cause major concern”:

While some of the above areas of concern apply more specifically to journal articles, most illustrate the methodological weaknesses of the current review of the evidence in the PDM. We have additional concerns than the examples which follow. However we provide illustrative samples for your review.

1) Non-reporting or delayed reporting of whole studies
While we believe that there are important studies that have not been included in your analysis, we do not have adequate time to perform a duplication of the search methodology described and to undertake another. However, we will mention that one study (Barrett 1998) which the authors of the PDM admitted they did not use. They stated that this was because “the complete manuscript could not be located despite an exhaustive search by the Library of Medicine”. The link they provide in the bibliography reference goes to a 404 error message. However by searching Google for this article, by searching for the title: “Psychological and social function before and after phalloplasty” Google provides a PDF of the study.⁴ In addition, as the International Journal of Transgenderism is the in-house journal for WPATH, a request to WPATH would have allowed the authors to access and consider this study.

2) Selective reporting of only some outcomes in relation to study findings:
Of Smith 2005, the PDM states “Most of the MMPI scales were already in the normal range at the time of initial testing. SCL global scores for psycho-neuroticism were minimally elevated before surgery 143.0±40.7 (scoring range 90 to 450) and normalized after surgery 120.3±31.4.” While this was true, the PDM fails to mention that all MMPI sub-scales but one were statistically significantly improved. While on average they started in the non-clinical range, given that patients begin at a range of scores from the non-clinical to the clinical range, decreases of the magnitude reported for some patients would take them from the clinical range into the non-clinical range. Incidentally the PDM also states “The size of the pool of available patients was not identified. Overall 325 consecutive adolescents and adults initially were ‘involved.” However the methods clearly state that the 325 were consecutive applications to the clinic for sex reassignment constituted the study pool and not a subset and nowhere do the authors use the term specifically quoted by the PDM: “involved”.

3) The omission of crucial information in the description of research methods and interventions:
Of Meyer 1979, the PDM states “The objective criteria, which were the subject of the publication, included employment status (Hollingshead job level), cohabitation patterns, and need for psychiatric intervention.” However there there are significant flaws in the methodology of Meyer that have been published in the peer reviewed literature and not been addressed.⁵ Briefly, the objective scoring system actually used 4 criteria - the ones named in the PDM and an assessment of legal problems as seen in this table from Meyer:

[GRAPHIC]

Specific problems with this scale include the fact that gay or lesbian transgender people are inappropriately penalized for being in a relationship. For example a lesbian transgender woman in a relationship with a female partner would have moved -2 to -4 points simply by remaining in a long term relationship through and after sex reassignment surgery. In contrast, a person who had no partner at the beginning or end of the study would have scored 0 post-operatively. However perhaps most concerning is that the operated group were followed for 62 months, residual unoperated 27, and subsequently operated for 21. Given that many of these events (e.g. psychiatric hospitalization or being arrested) were events that occur over time, the fact that Meyer did not correct for this would inevitably cause any group followed for a significantly longer period of time to have a higher incidence even if the rate of event per period of time were the same in both groups. (It should be noted that Meyer counted each negative event towards the score, so someone arrested and jailed twice would have a -4. This was not directly stated in the article, but can be inferred from one patient having a baseline score of -18, a greater score than possible if events were counted only once.) So if in all three groups, the average number of arrests per 6 month period was 1, the operated group would have an average score of -10, residual unoperated -5, and subsequently operated -4.

4) Omissions or misinterpretation of results in abstracts:
Of Kuhn 2009, the PDM states: “There were statistically and biologically significant differences for 4 of the 8 domains between the patients and controls: physical limitation: 37.6±2.3 versus 20.9±1.9 (p0.0001), personal limitation: 20.9±1.9 versus 11.6±0.4 (p < 0.001), role limitation: 27.8+2.4 versus 34.6+1.7 (p < 0.5), and general health: 31.7±2.2 versus 41.0±2.3 (p < 0.02). Information as to whether a high or low score was positive for the various domains was not provided. Wording from the abstract suggests that these 4 differences all reflected lower quality-of-life.” (Underline ours).

The appendix of the study provided the survey instrument which is also readily available online. From this the directionality of each score can easily be determined. Moreover, in the discussion sections Kuhn et al state: “Role limitations were significantly lower in TS compared with controls, which could be a sign for good gender assimilation and well-being”. Given that this information was available in the paper (though we agree not obvious in the abstract) that raises concern that this study may have only been assessed in abstract form. In addition when reporting levels of statistical significance the PDM states: “role limitation: 27.8+2.4 versus 34.6+1.7 (p<0.5)” which is not statistically significant. However the actual p value in this score which demonstrated transgender patients doing better was p < 0.05.

5) Inadequate or distorted reporting of harms:
Of Dhejne 2011, the PDM states: “All-cause mortality was higher for patients who underwent gender reassignment surgery (n=27 [8.3%]) than in controls (hazard ratio 2.8 [1.8-4.3]) even after adjustment for covariants (prior psychiatric morbidity and immigration status).” The PDM also states: “Suicide attempts were more common in patients who underwent gender reassignment surgery (n= 29 [9.0%] than in controls (adjusted hazard ratio 4.9 [2.9–8.5]).” While these are factually true statements, the PDM does not explain these in context and by doing so they overemphasize the potential harms. Dr Dhejne (who directly joined us in analysis of the PDM) made this important point in her original paper from 2011 cited by the PDM:

Moreover in addition to failure to discuss this crucial caveat, the PDM also leaves out a significant finding from this study. Dhejne et al divided their 30 year cohort in half and assessed morbidity and mortality differences in the early and later group. They found that the statistically significant higher mortality, and specifically suicide rate, was confined to those who had surgery in 1973-1988, and was not found in those having surgery in 1989-2003. That is, transgender persons operated on after 1989 had an overall mortality rate and suicide rate indistinguishable from a non-clinical sample. This is despite the fact that a higher mortality and suicide rate would generally be expected in any clinical sample of patients with a mental health diagnosis who are well known from numerous studies in the literature to already have high suicidality pre-treatment. In fact the only thing that the PDM stated about this difference from the early to the late cohort was, “The increased risk for conviction of any crime or violent crime observed during the 1973-1988 interval was not seen later.”

6) Confusing or misleading presentations of results, data and graphs:
While the PDM did not contextually interpret other results of Asscheman 2011, a particularly egregious misleading presentation of the data is in reporting substance abuse related deaths in transgender men. The PDM repeatedly reports the Standardized Mortality Ratio reported by Asscheman et al in the form: (n=X, SMR X [95% CI X-X]). For example the PDM states (our bold): “The major known contributors to the mortality difference between male-to-female patients and the Dutch population at large were completed suicide (n=17, SMR 5.70 [95% CI 4.93-6.54]), AIDS (n=16, SMR 30.20 [95% CI 26.0-34.7), and illicit drug use (n=5, SMR 13.20 [95% CI 9.70-17.6]).” In a couple of instances this was written out, but regardless, they consistently reported the number of patients (or percentage of, from which the number could be deduced). However in a single instance the absolute number was not reported: reporting deaths from drug use in transgender men. The PDM states: “Although overall mortality was not increased in the hormone-treated female-to-male patients, there were more deaths due to illicit drug use than expected (SMR 25 [6.00-32.5]).” The absolute number of cases was not presented, although the SMR is quite high. It is especially concerning that this was omitted given that the n in this case is a single patient. Had the PDM reported this in the same way they reported other SMRs, the very high SMR would be less misleading.

In addition to the 6 practices that “cause major concern” from the EQUATOR Network position statement that we feel provide a flawed analysis of the 33 studies selected for analysis, we also note that conclusions in the PDM have been drawn from studies not included in the 33 studies selected for analysis. For example, the PDM states: “The results were inconsistent, but negative in the best studies, i.e., those that reduced confounding by testing patients prior to and after surgery and which used psychometric tests with some established validation in other large populations. (Atkins et al., 2004; Balshem et al., 2011; Chan, Altman, 2005; Deeks et al., 2003; Guyatt et al., 2008a-c; 2011a-e; Kunz, Oxman,1998; Kunz et al., 2007 and 2011; Odgaard-Jensen et al., 2011).” None of the studies cited were included in the 33 selected for analysis. The statement drawn from these non-included studies does not just provide supportive information but states negative findings that were contradictory to what we believe the 33 included studies show.

Summary and Recommendations
While a complete analysis of all of the problems with the PDM is beyond the scope of this analysis, many challenges exist. We would be more than happy to provide further assistance to CMS in revision of this paper. Specifically, we make the following main suggestions:

Respectfully submitted,

R. Nick Gorton, MD
Lyon-Martin Health Services, San Francisco CA.

Kathy Hsiao, MD
Associate Clinical Professor, University of California San Francisco

Jamison Green, PhD
Immediate Past President, World Professional Association for Transgender Health (WPATH)
Adjunct Professor, California Institute of Integral Studies

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July 2, 2016

Tamara Syrek-Jensen, JD
Director, Coverage and Analysis Group, CCSQ
Centers for Medicare & Medicaid Services
7500 Security Blvd. C1-14-15
Baltimore, MD 21244

RE: Proposed Decision Memo for Gender Dysphoria and Gender Reassignment Surgery (CAG-00446N)

Dear Ms. Syrek-Jensen:

I am a mental health gender specialist who has worked exclusively with transgender, transsexual and non-binary people in public health settings for over a decade. Much of the work I have had to do was to help people cope with the crippling impact of gender dysphoria that could have been alleviated if they had access to medically necessary treatment. When treatment is available for the wealthy and the well-resourced, denying access to care is biased and unfair.

I work with people who have Medicare and Medicaid, referred to as Medi-Cal, in the State of California. Denying people access to care, which will be the impact of the denial of a National Coverage Determination (NCD) means that that people who have worked their whole lives and are insured by the government can’t access care.

What is more worrisome is CMS’s refusal to provide the NCD based on your review of the research will affect other insurance opportunities for transgender people.  I am deeply dismayed by the potential harm that can come from the review which I feel is flawed.  I am the curriculum chair of the Global Education Initiative of the World Professional Association of Transgender Health and am very familiar with the literature.  Another study was just released from Brazil this past month that shows that surgical intervention is beneficial.

I am also very familiar with the Medicare population. CMS is concerned that Medicare populations are in some ways different from the populations in various studies. This is true,  Medicare recipients have waited longer for access to care.  Some Medicare recipients have suffered from mental and physical health problems that have left them disabled.  These problems are the direct result of discrimination and abuse. The Center for Disease Control has been addressing the issues of toxic stress and Adverse Childhood Events.  Gender non-conforming chidren are bullied at a very high rate and abused physical, sexually and emotionally. This leaves changes to the brain that people attempt to cope with in a medical system that had discriminated against them because of how they look and who they are. Essentially, by saying that people may still suffer from depression or suicidality post surgery, you are saying that because people were absued as children, they will be systemically abused again through the denial of access to care.  While you are not saying you are denying care, in practice, that is what is true.

It’s hard to get well as a transgender person in America.  I am grateful for the many changes over the past few years, many of which, like the Pentagon just lifting the ban on transgender people serving their country, come from the government.  It is why this feels very confusing and upsetting. 

This is such a small populationthat has very diverse needs.  Unlike appendicitis where there a limited choices for treatment, each person needs individualized care.  Our goal is to reduce suffering which is what gender dysphoria is. Some people need several surgeries and some people need not surgical intervention.  We cannot do studies that will be robust enough to meet you request.  The population is too small and too diverse and we need toprovide care when we can—not make people jump through more hoops. While it is technically anecdotal and professional experience, we know that surgery improves the quality of people’s lives. 

Please re-evaluate your data with consultation from experts and attend to potential damage and unnecessary suffering that the current review will cause. 

The opinions expressed in this letter are my own and not that of my employer.

julie graham, MFT
San Francisco, California

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Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group, CCSQ
Centers for Medicare & Medicaid Services
7500 Security Blvd. C1-14-15
Baltimore, MD 21244

Dear Ms. Syrek-Jensen:

As a professional association whose members are called on to provide medical (including psychiatric) and surgical care for individuals with gender dysphoria, the Lesbian, Bisexual, Gay and Transgender Caucus of the American Academy of PAs submits this comment to reiterate our position supporting medical, mental health and surgical treatment as beneficial and medically necessary care for individuals who meet the diagnostic criteria for gender dysphoria.

The PDM as it stands presents serious threats to a wide spectrum of care for gender dysphoria not provided under Medicare. The basis of concerns is not from the decision not to issue an NCD, rather, the basis of concerns is the PDM's analysis of individual studies and overall methodology. We have grave concerns that the PDM will be widely used to justify private and public insurance denials of care potentially undermining access to medically necessary care of gender dysphoria for transgender people.

Within PA's professional association, the American Academy of PAs has adopted a number of policies and positions that speak to related areas of concern including nondiscrimination in the delivery of medically necessary health care based on gender identity, and the elimination of arbitration condition-based (insurance) exclusions.

Our reading of the scientific literature and research indicates that therapeutic treatment, including transition-related surgeries, are intended.and expected.to significantly restore areas of social, psychological and physical functioning that may have been impaired by gender dysphoria, and allow the body to function in a manner consistent with the patient's innate gender identity.

Further, the World Professional Association for Transgender Health's Standards of Care recognize that while patients' needs differ and treatment decisions should be individualized, for some individuals relief from gender dysphoria cannot be achieved without modification of their primary and/or secondary sex characteristics to establish greater congruence with their gender identity.¹

For these reasons, we are very concerned by the individual analysis of the scientific literature as well as the overall methodology presented in the recent Proposed Decision Memorandum on Gender Reassignment Surgery for Medicare Beneficiaries with Gender Dysphoria. The analysis presented in the memorandum has the potential to be used in unintended ways, including as justification by public and private insurers to deny coverage for transgender-related surgeries, a result that would be contrary to our organizations' support for the removal of barriers for the treatment of transgender individuals, including transition-related surgeries.

A 2011 Institute of Medicine report entitled "Essential Health Benefits: Balancing Coverage and Cost" on comprehensive health care reform reinforces the importance of "[ensuring] that insurers do not make arbitrary and discriminatory decisions' 'rather than assessing the individuality of each case when making medical necessity decisions and applying clinical policies."

We respectfully request that CMS conduct a re-examination of the literature it reviewed in developing the Proposed Decision Memorandum. We also request CMS conduct this review in consultation with experts in the field of transgender health and transition-related surgeries and offer the experts within our own association as additional assistance in this effort.

In the absence of a National Coverage Decision on Gender Reassignment Surgery, CMS should make clear that Medicare coverage for transition-related surgeries would still be available on a case-by-case basis and that nothing in its analysis should be construed as justification to deny coverage for transition-related surgeries in other contexts.

The LBGT PA Caucus of the AAPA, Inc. appreciates the opportunity to comment on the Proposed Decision Memorandum and looks forward to working with CMS on this important issue.

Sincerely,

Laura Jennings, PA-C
President
LBGT PA Caucus
c/o American Academy of PAs
2318 Mill Road, Suite 1300
Alexandria, VA 22314
info@lbgtpa.org | www.lbgtpa.org

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By Nehael Jae Shields
The requestor of this NCD consideration.

This commentary is My personal assessment of the proposed decision suggested by CMS concerning the issue of Gender Dysphoria Surgical Remedies. The Commenter is Nehael Jae Shields, she is [PHI Redacted] the requester of the NCD review. [PHI Redacted] The comment is a culmination of her experience with CMS, the personnel, the process, the federal register requirements and the science. Ms Shields has reviewed the same data as CMS in fact she provided most of it. The following should be considered as sworn testimony [PHI Redacted]

My comments might seem harsh to a casual observer, I get that! As a seven year veteran and requester of this NCD I find myself in an unenviable position to make this negative assessment. As patient the notion of healthcare advocate was completely foreign to me at the eve of this quest. When it was clear no one would fight for me or my transgender family, I embraced the burden. I rushed in with a naive perspective of the many artificial barriers to coverage . [PHI Redacted] the conviction this hurdle to care was substantial with layers of bigotry and entrenched ignorance and a kaleidoscope of political intentions. My hopeful approach came from a belief government is part of the solution not the problem. I quickly realized my expectations were not equal to reality on the ground. It was abundantly clear this fight was rout with obstacles formed from decades of mans lowest convictions.
From 2009 to 2011 I began to read and learn everything related to this subject and the glaring impediments to care. What I couldn't learn from the printed record I gleaned from countless conversations with CMS staff and community members including medical professionals and political leaders, white house included.

My first goal was to determine the best course forward with consideration of the guide lines harvested from the Social Security Act of 2003. I was encouraged by the CCSQ and the CAG to file a DAB appeal to remove NCD 140.3 an easy to debunked ban of transgender care adopted in the early 80's. A NCD established in an environment of minimal data and a wealth of social condemnation and hysteria. After careful review I was convinced that a DAB appeal would in fact defeat 140.3 but in its wake a vacuum of coverage would still exist. That was a year of time I couldn't afford to lose.
In late 2011 I rejected that approach and filed a Formal NCD request to replace 140.3 with a comprehensive NCD of affirmative coverage. The appeal was 537 pages of argument and attached scientific data surely enough to be accepted. I was greeted with sympathy and concern but the political battle within the agency was already ignited. With impassioned effort I witnessed a horror of obstruction, political wrangling and the sorrowful public servant so immobilized by the agencies hollow breath stockholm syndrome had numbed their senses, they didn't even know it. This exhausting process was taking its toll on me.

Despite this reality I aggressively campaigned for a hearing of my request. My attempts to talk to those most influential were ignored and even worse, I had my phone blocked on multiple occasions by executive level persons, whose names will be withheld at this time. Discussions that did find willing ears resulted in conversations centered around process and the political street fight over timeliness or sociological appropriateness, rarely science. My plea to the White House and my Senators was received but ultimately I was referred back to individuals equally as frustrated as I. The agencies lower tier of officials were caught in the middle and the political wrangling waged on. I argued the politics being touted for delay was inappropriate and constituted a violation of law. After a year and a half of arguments between CMS and myself the NCD request was accepted and published to the website on 03/29/13. Finally the case would be heard and new guidelines would hopefully prevail.

NOT so fast! The accepted NCD request was removed from the site and ended the very next day. The agency deemed a newly filed DAB challenge was better "for them of course". This approach would assure the political equivalence of Caesar Augustus washing his hand to absolve his treachery. The politicos had plausible cover now, as this decision would be established by the Department Appeals Board not CMS.
As I noted before I had already rejected that direction because it didn't advance coverage it simply removes the offending policy. Not only was this a disappointment to my effort it also served as the only time in history such an action was committed by CMS. Not a single accepted NCD has ever been removed without review mandated by the federal register, EVER. Even to the casual viewer this certainly seemed to be an action driven with politics not science....a violation of the law. I filed a complaint with the OCR and a two year investigation produced a ruling of "We don't have jurisdiction in this matter" The OCR proved to be a toothless arbitrator, it does nothing but hides its shame behind a jurisdictional barricade. Its independence as a oversight agency is in real question. I know my civil rights were violated here but I moved forward. I have not ruled out legal action in this matter just yet.
On 03/31/2014 the DAB struck down NCD 140.3, great!

Not so fast! As it turned out CMS accepted the ruling and directed local contractors to establish a process to measure medical necessity and reasonable standards test. Great, so far so good?

Not so fast! As it turns out CMS also decided that these new guidelines would not be published to beneficiaries? I think this move by CMS is telling of the level of contempt it has for assisting gender dysphoria patients access to coverage.

I saw this effort by CMS as a deliberate attempt to comply with the DAB ruling but simultaneously mitigating the potential political blow back. The ultimate effect marginalized patients awareness of possible coverage and additionally it deepened the distrust of physicians begging Medicare to negotiate credible reimbursement rates. The level of the commitment by CMS to reimburse doctors and hospitals is at the root of the minimized often crippled medical infrastructure for transgender care. CMS now had the perfect and politically correct formula to maintain the statuesque of marginalized coverage for transgender patients. I don't suggest CMS is evil or malicious but I do believe they are complicit in a fraud, a manifestation of administrative compromise internally, which effectively projects a posture of indifference. The inability to adopt a transparent approach to fund care is just a indication of a much deeper conflict of will within the agency.

In light of this wholly familiar reality of obstruction I filed a demand for reinstatement of my original NCD request on the basis I was deprived due process under the guidelines of the federal register. On 03/30/2015 my case was again accepted and published to the web for comment and review. Now the committee has proposed a decision reminiscent of past behavior. I am quite aware due to reliable contacts within CMS and the committee that considerable decent exists with this proposal. These contacts are quite upset coverage is not being made universal . They are very sympathetic of transgender care and believe visibility is critical. Any strong talk of unity is false. However decent was placated by open calls for new studies. There is no commitment of funds or resources mind you just a call for robust trails. Still the lack of conviction and will to cover care seems to be thoroughly in control of the conscience at CMS. This activity is of course wholly reprehensible and technically an obstruction of the law. Science is the only measure that can be discussed, ever, as stipulated in the SSA 2003.

There have been heroes within the agency over the years who put their job on the line when it mattered most, I thank them for their integrity. Some leaders actually quit in opposition to the path CMS was employing. Remarkably I have maintained an objective role [PHI Redacted], respectful yet demanding at all times. [PHI Redacted] yet the resistance to embrace logical solutions evades the agency. The quest for reliable medical coverage still in question today. I could tell the whole sordid and pathetic tale in detail and someday maybe I will but until then I must address yet another rancid bilge of obstruction this proposed decision represents.

I intend to extract and identify the fantasy, the fakes and folly contained in this review. In all fairness I will also applaud areas in which I agree. I will even address issues not contained in this report that in my opinion must be included in any analysis. I will thoughtfully offer an authentic world portion of reality from the perspective of the patient. In the end I hope to illustrate actions that should be encompassed in the final decision. CMS can decide to learn from my perspective and experience or they can opt to discard it like much of the sound data already ignored. Whatever they choose to do it will not go unnoticed or unrequited. [PHI Redacted]

Interpretation of Proposed Decision
conversion is from English to Truth

Proposed Decision Memo for Gender Dysphoria and Gender Reassignment Surgery
Currently, the local Medicare Administrative Contractors ( MACs) determine coverage of gender confirmation surgery on an individual claim basis. This process has been shown to be wholly inadequate and suffers from systemic issues of visibility and access in all regions. We recognize this marginalizes medically necessary coverage but that's the best we can do for such a small segment of our beneficiaries. To make matters worse we will continue to not publish this potential coverage nor will we publish or track participating physicians. The system is difficult to navigate so we will offer no assistance to patient or physicians in need of guidance. We will not negotiate reasonable reimbursement rates with the medical institutions who provide these services. CMS will continue these practices and will not issue a National Coverage Determination (NCD) at this time. Our review of the wealth of evidence of positive outcomes when vetted by our restrictive and ascended standards we find the data becomes inadequate. In light of these facts we are prepared to cast this data aside and determine insufficient evidence exists. We will stipulate for the record our assessment is inconclusive for the Medicare population at large.

Because we have neglected our role historically in providing coverage or actively sounding grave concerns surrounding gender dysphoria and the need to cover treatments we lack credibility to act as part of the chain of treatment to beneficiaries and we are taking no action to correct this failure. Because of these collective failures of CMS in this area we currently lack the competence to create clinical appropriateness criteria for cohorts of Medicare beneficiaries.

Instead of real action we are calling for robust trials knowing our beneficiaries and respective providers lack the resources to do so on their own. We will not put any skin in the game we only say this so we don't look completely heartless. Additionally we wish to present an air of confidence in our local systems even though we have been informed otherwise because frankly it sounds good while we do nothing. We are satisfied with the statuesque and have no intention to facilitate a better approach. The gender dysphoria patients are on their own. Feel free to comment we will pretend to take it serious. Don't get hopeful we are likely to just proceed in the path of least resistance and publish a determination much like this one.
Thanks You CMS

I am sure CMS is proud of their high standards when reviewing evidence. In any study or review there must be thresholds or tolerances maintained to ensure quality. CMS has a long history of this superior level of scrutiny, however in this case of gender dysphoria I contend CMS has gone too far afield. The phrase throwing the baby out with the bath water comes to mind.

The committee has determined that most of the available evidence fails to meet the CMS quality test. I reject this conclusion. Over the course of these many years I have learned an important lesson about "evidence" and "verification" and how subjective they are in matters like this review. Experience has taught me that A person or organization can honestly incorporate these seemingly rigid realities in a profoundly flexible manner. The conclusions of a personalized perspective are seldom recognized by the observer, they wholly believe their understanding or choices are right. In fact the observer acts without intention to evade impartial findings. The concessions are guided by subliminal influences like impractical standards, intellectual bias, personal prejudices, indifference or fear. That said many factors can unduly influence this process of knowing all the facts.

In this review I believe the committee has been swayed on five fronts concerning methodology. By a systematic approach so narrow the wisdom of our inherent humanity has been ignored. To any who would contend humanity or compassion has no place in matters of research or review. I would say you have probably outlived your usefulness in a process like this review or any review. Science medicine without humanity or compassion is to ignore the fundamental reality that separates us from inert matter. Sorry but I don't believe a rock should decide whether I receive medical care or not. Call me crazy but that's not science.

I believe the standards regarding what is acceptable data is way to lofty. The standard set is to exclusionary given the neglect by the medical community of this population. I would argue any evidence whether it be ascendant or not must be reviewed in its context. For example, I believe the medical practitioners testimony and medical practice statistics should be given equal standing as trials. This is a compromise that needs to be considered in the light of the historic medical contempt this community has endured. Historic neglect by the medical industry in which CMS is apart must not interfere or disregard proven medical practices.

More importantly the committee has chosen to assess only data related to surgical procedures. The complexity of this disorder and the array of treatments is not served in this restrictive approach. It is common sense that if you only look at problems in a myopic manner you get cooked conclusions. A review of practices designed to omit any evidence or step in the care of patients is doomed to failure and only guarantees marginalized results.

I would also stipulate CMS has ignored my request for a hearing on all aspects defined in my NCD request filling. They narrowed the scope of my request on their own accord and without my consent. I have been told this was done because some felt it was better to only look narrowly at surgical remedies. I reject this idea, I am of the age of consent and able to self determine my wishes. My civil liberty therefore is being violated yet again by the agency

When one reviews my submitted request for NCD coverage they would find the appropriate linkage to all aspects of proper treatment of Gender Dysphoria. The fact is you can't expect solid determinations unless you know the linkage between protocols and their effect on the patient's big picture. Gender Dysphoria is unique in its manifestation and as such requires a unique review. Simply reviewing surgical procedures without a total picture is "practicing" quack medicine. Making the assumption every patient is the same and requires the same attention is to reject the preponderance of clinical evidence to the contrary. I encourage CMS to readdress the surgical question in its totality. Surgery in the case of a gender dysphoria patient is not an intervention of first resort nor is it a procedure exclusive to positive outcomes.

It is my understanding a (MEDCAC) review was rejected this is troublesome to me. I find the decision to not conduct a review fosters an appearance of partiality to CMS wishes rather than science. I would argue that given the questionable behavior in my case and the past history surrounding this community it is required to order a (MEDCAC) review. If CMS heeds this call I believe the board should consist of no less than one third members experienced in this area. Of the third I believe at least six members should be surgeons from the gender industry. This proposal does not forego the customary six member advocates. I believe this frame work would guarantee an impartial review of evidence.

Forth

The assessment should not simply determine the benefits of treatment it is also the assessment of what non-treatment, marginal treatment or visible access represents in human terms. I would stipulate that the statuesque suggested is not only a failure to adequately assess evidence but also an immoral abdication of CMS's role in the care of Transgender and Intersex people.

In science and medicine the notion of impartiality is a foundational stone in which medical professionals are built. The philosophy is fostered to guarantee sound judgment it the presence of hope torn cases of medical care. I believe this kind of practice is merited in most individual doctor / patient experiences. The act of separation to our inherent empathy is especially relevant in cases where large numbers of effected souls are compromised by any malady where treatment is required. As healthy sentient beings we must protect all parties in the application of medicine from the patient to the doctor, the lab technician all who participate in the search of cures including those responsible to fund such practices.

That said the practice of impartiality does have an inherent flaw. The embrace of the impartial spirit is noble but in the face of medical neglect this practice must be marginalized. It is incumbent for professionals to recognize such disparities in treatment and act with cautious indignation and action. In the case of transgender care I believe this threshold has been met. It is not ok to recognize and then apply marginal action to a community's medical emergency. If the committee believes their proposed non action is adequate to this brutal crisis of neglect then I would assert the agency has lost its way. This harsh assessment is a fundamental failure of CMS and in my opinion clearly manifested by the statuesque direction. If CMS was truly committed to insuring the welfare of patients suffering with this insidious disorder the preponderance of data would ignite a willingness to provide coverage on the national level while committing to a proactive call for fully funded studies or trials. Instead of acting as a true advocate with a robust hippocratic spirit CMS has proposed a course of inaction while tacitly observing the gender dysphoria battle from the far off hill. This is qualitatively the most offensive and crushing thing I have witnesses in my seven years navigating CMS [PHI Redacted] and I can assure you I have seen its worst.

On its own this proposed decision might be palatable but when one compares the nullified NCD 140.3 and its supportive evidence, the predecessor to this request, one is justifiability appalled. NCD 140.3 was a mockery to science and served as a social political platform for bigotry and hysteria of the 1980's and yet that pile of rubbish passed the touted "CMS standards and quality care methodolatry".

When you compare the text of each decision the same language is adopted. Even the call of more trails to fill the gaps quote exists in both. The record is clear such calls were hollow then and thirty five valuable years later the same. All those wasted years on sentiment and contempt. One doesn't need to look far to find reason for patients doubt CMS's commitment to this group or any group.

Thankfully the Department appeal Board saw NCD 140.3 for what it was and rejected it on 04/2014. Like the DAB I unequivocally reject the premise the committee asserts in this propose decision. Further I doubt the review to date is comprehensive at all. Frankly it appears more analogous to a shredding party then a sincere assessment of available data.

while I read the proposal I was struck by the profound disconnect of the committee and what this disorder means is in human terms. A conspicuous insensitivity to the time element associated with care. A failure to recognize the long history of neglect in the industry and more directly CMS's complicity. It is Remarkable that CMS believes time is a commodity in abundance to deliberate or mitigate available data when even the casual observer can grasp the opposite truth. The proposed decision reflects an anesthetized will and necrotic agility to a myriad of failures supporting treatment of the gender dysphoria patient. Urgency is essential but the needy are met with a labyrinth of platitudes, misdirection and federal register jujitsu. Instead of care the patient is subjected to insulted dignity, vacant commitments and procedural fights that act as a placebo of hope.

There is a wealth of data and practical applications of sound safe medical treatments with positive outcomes even if CMS chooses to ignore it. Decades of research, strict guidelines and dedicated practitioners have waged war with gender dysphoria. A community of healthcare professionals who have faithfully stood in solidarity with the "Do No Harm" oath. These people have managed to developed sound medicine to address an invisible community. The efforts displayed are reminiscent of a battle not so long ago when HIV patients were subjected to institutional neglect. The parallel is so clear and we all know the sad reality that discrimination was at the heart of it. CMS chooses despite these achievements of sound practices and proven results to cast a shadow over this fine work. They casually dismiss clear evidence, decades of successful medical practices to justify their inaction.

CMS believes it's been diligent and careful about its review. They operate satisfied the standards of assessment weigh the medical necessity mandate. The agencies participation has been routinely nonexistent in efforts to apply care to this marginalized community and when engaged they have managed to administratively suppress progress. Further in my experience the agency seems more receptive to political voices rather than the cries of the suffering.
Their record of inaction is out paced by private insurances sprinting to recognize needed coverage. The private sector has accepted the sound judgment of the medical communities expertise in this matter. Nobody in their right mind would argue transgender health is definitively explored or perfect. That acknowledgment is not an invitation to dismiss or denigrate current science and withhold endorsement. This is an opportunity to validate treatment and invest in the infrastructure necessary to impact the patient and the many institutional failures in a positive manner.

In all the available evidence reviewed or discarded there is not a single consequential red flag, no smoking gun of a negative medical evidence to escalate the measure of caution or pause suggested. This path of delay and collating of potential deficiencies in methodolatry or outcomes is not based in science fact but rather the impunity of will. In truth the data reviewed points to a clear need for surgical remedies in cases where psychotherapy and hormone intervention are inadequate to provide lasting relief to the patient. A lack of credible caution is no reason to subject those compromised to further harm. A referral to anything short of universal coverage is inadequate.

This obstruction of universal access illustrates CMS's dismal inaction while hiding behind arbitrary standards and a blind eye to beneficiaries need. I am firmly convinced as are the leading medical associations globally that delay is not acceptable. Patients will continue to suffer needlessly in the shadows or worse be overwhelmed by despair. CMS's suggested path is an abandonment of conscience, it's immoral and serves to inflate the already horrendous suicide rate among this population. The lives of those who could be saved but aren't because of your failure.

CMS must become more agile to accommodate the marginal segments of its beneficiary population. Failure to address issues with a nimble worldview breeds contempt for real patients. Deliberations failing to assert thoughtfulness or reasonable doubt of long held standards means the evolution of medicine is fractured. Whether it be evidential standards or administrative protocols designed to streamline access CMS must resist the mindless adherence to normative pathways. If CMS continues to assert such standards in ALL reviews, coverage to emerging health crisis will be unsatisfactory. This intransigent behavior invites skewed conclusions that overlook and under serve beneficiaries associated with marginal industries or even those patients boxed out by sociopolitical hysteria. CMS has a choice to make, accept this potential vulnerability and do nothing or evolve. A dismissal is tantamount to malpractice. I assert that this scenario has already been realized in this proposed decision.

For the purpose of this comment I must address a few data points to establish context. The population of the transgender community has long been difficult to measure. The Williams Institute a division of UCLA School of law released new demographics on the community. According to their report roughly 1.4 million Americans self identify as transgender. This figure is likely higher given the nature of LGBT historical undercounting due to stigma and fear of coming out publicly. For this Comment I will adhere to 1.4 million or .06% of the population. The report also delineated the statistics according to age. The data reflects that adults over the age of 65 numbered .5% or 7,000.00 individuals. I will also include the .2% or 2,800.00 individuals who are under 65 and disabled by gender dysphoria. It is well known many trans people are on disability with a duel diagnosis of depression, anxiety and PTSD. These two figures totaling nearly 10,000 Social Security beneficiaries in need of trans related coverage. At this point I should note that I request this data from CMS under FOIA and it was withheld. Therefore I will use this figure to illustrate just how underserved this segment is under the statuesque proposal.

The population of intersex persons must also be considered in any accounting of beneficiaries. That said I was not able to identify any studies that measured this population by age. I will not include intersex people in this assessment. It is important to note however many intersex patients require similar treatments sought by trans people. This population constitutes 1.7% of Americans. If this population was included in my argument it would likely double the beneficiary total suggested above or 20,000 patients.

Of the ten thousand transgender beneficiaries it is likely a portion do not require surgical intervention. To accommodate this reality I will deduct 20% of the population established thus far. The number I will use to estimate the beneficiaries in need of surgical intervention is then 8,000. I believe this is likely an undercount of actual patients but for this illustration it will do.

CMS has indicated that in the absence of an affirmative NCD they will rely on (MAC) resources to manage the needs of beneficiaries. They indicate this process is the current solution in which they have faith.

I will stipulate for the record my experience with MAC's has proven to be fruitless. I have on several occasions attempted to infiltrate this system for ANY information regarding treatment options. The only information I received was a brief reading of the minimal requirements to apply for coverage. This was information like; one must be 18 years of age, one have two signatures from medical doctors etc.. They would not provide assistance in any other manner like provider's, rates or restrictions nothing more. In fact the medicare.gov system failed me completely.

I have attempted access several times over the course of the two years. Each experience was met with hours not minutes waiting and vacant information. The repeated attempts proved pointless and failed to advance my need of coverage. The issues didn't stop at medicare.gov, I also attempted to gain information from Region 3 office in Philadelphia and Novitas with even less success. This failure to gain any useful information from CMS or their contractors is not an indictment of my ability or effort but the dismal failure of CMS.

After the Department Appeals Board vacated NCD 140.3 the agency in compliance withdrew the NCD and instructed the local MAC's to establish coverage protocols and review claims on a case by case basis. However the agency also decided not to inform the beneficiaries or the industry of these pathways. A reference to the riddle "Does a falling tree in a forest" seems appropriate here. This policy doesn't serve the patient or the medical professionals it serves CMS.

I requested an NCD in the hope I could facilitate CMS to publish a public decision so visibility could be obtained. So patients and medical providers could assess CMS intentions and provide universal mandated coverage to all regions of the country.

Under the current framework each region can independently frame their coverage standard. Regions of a more conservative bend would undoubtedly restrict access more than more liberal regions. This assertion is supported by the facts I acquired from CMS. A FOIA search indicated all procedures since the DAB ruling in 2014 originated from Region 8. I don't believe in coincidences and I don't think this is a fluke. The motivations our subjective here but the effect is objective and spits in the face of everything CMS is suppose to represent. I don't mean to suggest this disparity is rooted in visibility alone in fact several factors could be at fault. One thing is indisputable the population of beneficiaries is not isolated to Region 8.

The data I received from CMS indicates that of the Region 8 claims all the procedures were Orchiectomy scrotal/inguinal approach; laparoscopic; CPT 54520, 54690. This is in no way a reflection of the beneficiary needs. Much more investigation is required to assess motivations. That said the evidence shows that no Vaginoplasty, Vaginal Construction or even Amputation of Penis were claimed. These procedures are the three most often request procedures in the industry yet no claims were administered. There is no rational reason I can discern to justify or accept this disparity.

The most alarming data in the FOIA I received from CMS is the disparity in the number of cases administrated. Region 8 as I stated before was the only region to report activity. That is alarming, however the total number of cases was 29. On average the private insurance industry administers 12.5% or 800 surgeries per year in the US while CMS's local system (MAC's) manages .18% of surgeries beneficiaries require. This is not just an indication of a broken system this is equivalent to malpractice by CMS. Of the 8000 identified members only 14.5 cases per year are administered.

As I inferred to earlier the marginal visibility of CMS coverage is a problem. It not only affects the awareness of service for patients it also alienates medical providers to contract with CMS. This industry has been forced by coverage neglect for so long cash and carry became a standard reimbursement policy for services rendered. Private insurance is light years ahead of CMS on recognition of quality of care as well as reimbursement equity . The policy of indiscernible coverage in the statuesque and the rejection of a NCD guarantees beneficiaries will be underserviced.

It is well known CMS does not pre-authorize reimbursement however it is my opinion this practice should be considered to generate goodwill with providers, especially surgeons and anesthesiologists. CMS has a responsibility to do what it can to open pathways for coverage if it fails to publish an NCD. Opening this industry to precertification would facilitate greater participation and much needed care to its members.

Members right now have no reliable assistance at CMS to navigate the local system. As I indicated my experience reveals a broken infrastructure to facilitate care. If the Agency fails to draft an NCD it must not refer members to an inadequate system. Many improvements must be made to ensure a seamless pathway to treatments. I suggest the agency establish an advocate position or a comprehensive publication to assist patients in the process. This would be responsible to identify contract physicians, specialist and facilities who provide care to this segment. The assistance should additionally provide detailed avenues if preauthorization is adopted. A failure to address these concerns in irresponsible and would further illustrate the contempt CMS has for the transgender member.

It' offensive to see the agency call for more robust trials given their past calls were simply hyperbole. Trials are a wonderful idea especially studies investigating the organic origins of gender dysphoria or even techniques to improve procedures and recovery timelines. All valid research goals but not at the expense of the patients in need for care now. If you fail to recognize the need for robust coverage the patient suffers. When you restrict coverage or underfunded it, based on unrealized improvements or contrived inadequacies the patient suffers. When you fail to recognize the benefits in current practices or protocols with proven and positive outcomes the patient suffers, It's frankly immoral. Such motivations fostering this incremental obstruction are suspect. It's difficult to believe CMS would be able to draw the conclusion that screening practices for legitimate medical necessity are lacking in the evidence I submitted.

There are so many failures in CMS's handling of [PHI Redacted] my fight for coverage. I can hardly articulate all of them in this comment . [PHI Redacted] What is CMS for if not to support the health and wellbeing of its members. [PHI Redacted] I know I have done everything in my power to intelligently advocate for [PHI Redacted]others not so able to support their own needs. CMS has been the primary obstacle is this quest. The agency is not alone in its failure, the gender industry too must accept its part and actions to improve services must follow.

CMS will do as it sees fit as it always does but make no mistake the actions historically and those decisions now just a proposal do not serve the patient. The actions of CMS only guarantee more people will suffer and die. I make no apology for my harsh assessment of the proposed decision by CMS. I believe my comments are objective and is a true assessment of the pathetic processes. If CMS would like to discuss these observations in depth I am available to assist. I doubt however there's any willingness on CMS's part to truly improve the serves to the transgender members. I even have grave doubt CMS will even read this comment in it totality.

Thank You for your time and attention
Nehael Jae Shields

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Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group, CCSQ
Centers for Medicare & Medicaid Services
7500 Secmity Blvd. Cl-14-15
Baltimore, MD 21244

Dear Ms. Syrek-Jensen:

The American Academy of Nursing (the Academy) submits this comment on CMS's Proposed Decision Memorandum on Gender Reassignment Surgery for Medicare Beneficiaries with Gender Dysphoria. As an organization of clinicians, educators and executives, our members are deeply concerned about the ability of individuals with gender dysphoria to access needed care. This concern is based on Academy positions including our Position Statement on Health Care for Sexual Minority and Gender Diverse Populations (2012)¹ and our recently adopted Position Statement on Healthcare Services for Transgender Individuals, which declares the Academy's support for "initiatives to address the health needs of trans gender individuals and ... policy initiatives that reduce the heath care barriers that most transgender individuals encounter."

The Academy's positions were adopted after careful review of the relevant literature. We recognize that treatment for gender dysphoria, including surgical intervention, can restore areas of social, psychological and physical functioning that may have been impaired by gender dysphoria. Transition-related surgery allows many individuals with gender dysphoria to function in a manner consistent with their gender identity.

The needs of trans gender individuals differ. While treatment decisions must therefore be individualized, the World Professional Association for Trans gender Health's Standards of Care recognize that for many individuals, "relief from gender dysphoria cannot be achieved without modification of their primary and/or secondary sex characteristics to establish greater congruence with their gender identity."²

We are very concerned by the analysis of the scientific literature presented in the recent Proposed Decision Memorandum on Gender Reassignment Surgery for Medicare Beneficiaries with Gender Dysphoria. We do not dispute the decision not to issue a National Coverage Determination at this time. We recognize that the memorandum is intended to justify that decision. However, we are concerned that the analysis provided in the memorandum may be used by some payers for other purposes, including denial of coverage for trans gender-related surgeries. We are aware that other commenters have detailed their concerns with the methods reflected in the Proposed Decision Memorandum and with its limited use of available research.

We urge CMS to reexamine the literature it reviewed in developing the Proposed Decision Memorandum. We also urge CMS to consult with experts on transgender health and transitionrelated surgeries in conducting this reexamination. Of course, the Academy would be pleased to offer our support for this effort.

In addition, we strongly recommend that in the absence of a National Coverage Decision on gender reassignment surgery, CMS should emphasize that Medicare coverage for transitionrelated surgeries will be available on a case-by-case basis and that its analysis should not be construed as justifying denial of coverage by other payers for such surgeries or for other services for transgender individuals.

The Academy appreciates the oppo1tunity to comment on the Proposed Decision Memorandum. We look forward to working with CMS in addressing this important issue.

Sincerely,

/s/
Cheryl G. Sullivan
Chief Executive Officer
American Academy of Nursing

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Tamara Syrek Jensen, J.D.
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard C1-14-15
Baltimore, MD 21244-1850

Re: Proposed decision memorandum on gender reassignment surgery for Medicare beneficiaries with gender dysphoria (Administrative File CAG #00446N)

Submitted online

Dear Ms. Syrek Jensen,

We are submitting here our comment on the proposed decision regarding whether the Centers for Medicare & Medicaid Services (CMS) should issue a new National Coverage Determination (NCD) regarding gender reassignment surgery (GRS). All Medicare beneficiaries, including transgender individuals, should have access to high-quality coverage and care, and we appreciate the attention CMS is devoting to this issue.

The proposed decision memo, in seeking to answer the question of whether there is sufficient evidence to conclude that GRS improves health outcomes for Medicare beneficiaries with gender dysphoria, asserts that the evidence is inadequate to support this conclusion. However, we have grave concerns regarding flaws in the analysis that CMS cites to support its proposed decision^[1] and the framing of the decision itself. Given the disastrous and far-reaching impact across more than three decades of the previous NCD 140.3, we are deeply concerned that both the analysis and the decision could have similar consequences, seriously undermining access to coverage for medically necessary health care services for transgender Medicare beneficiaries and other transgender individuals.

We therefore urge you to revise the decision to clarify that Medicare coverage for GRS is available in appropriate cases and to ensure that the decision does not conflict with recent advances in transgender health, including the 2014 decision by the U.S. Department of Health and Human Services (HHS) Departmental Appeals Board overturning Medicare’s ban on coverage for GRS.

While we acknowledge that a new, comprehensive NCD for GRS may not be warranted at this time, given that NCDs are relatively rare for Medicare procedures, we are concerned that the absence of any guidance whatsoever may result in routine denials of coverage of medical services and procedures in an at-risk population that has already suffered through decades of discrimination.

Concerns about the literature review and analysis

We are aware that various medical experts who specialize in transgender health care are submitting detailed comments about the specific and widespread flaws in CMS’s analysis of the scientific literature. While we defer to their expertise, we would also like to underscore that one does not need to be a clinician or an expert in transgender health to perform a competent literature review on the topic. However, the literature review underpinning this proposed decision is sadly lacking. What struck us most was the mischaracterization of numerous studies to a degree that unfortunately seemed to suggest negative bias (bias against surgical transition procedures) on the part of supposedly neutral reviewers.

The methodological concerns we uncovered included most or all of those cited by organizations dedicated to ensuring quality literature reviews. Entire studies were omitted either without mention at all or with the excuse that the article “could not be found.” Our consulting firm does not have the resources of CMS, and yet with diligence and a researcher accessing electronic journals at a large public library, we have been able to quickly obtain hundreds upon hundreds of relevant articles including those which were missing from the CMS analysis. Another serious issue is that study outcomes were selectively reported. For example, in reporting on performance on MMPI subscales in Smith et al (2005), the CMS review reports on just one, and fails to report the statistically significant overall improvement on all but one subscale. Furthermore, the quality of evidence was downgraded by misidentifying the type of study, claiming that crucial data was not presented when it was, and other strategies. For example, Kuhn et al (2007-11) is identified as semi-controlled when it is a case-controlled study. Or in another instance, the review claims that Smith et al (2005) does not identify the patient pool when the number is in fact clearly stated.

Unfortunately, the literature review also clearly inserts hostility to the transgender population, or at least a callous ignorance, that is not reflected in the literature being reviewed. For example, in the description of Newfield et al’s study (2006) of transgender men the CMS review describes them as “natal female participants identifying as male,” phrasing and terminology which is not used by Newfield. The term “natal female” is prejudicial against these individuals gender identity as males, and flies in the face of both clinical and scientific understandings. These represent only a few of the many flaws in this literature review.

Medicare population concerns are a Red Herring

The proposed decision cites a lack of studies specific to the Medicare population but does not elaborate on what might be different about this population. GRS is documented to be successful in patients well over the age of 60-65, so age does not seem to be a factor. Some Medicare recipients are younger and have qualified under SSDI, but GRS has also been performed successfully on individuals with a wide variety of other conditions. Indeed, the WPATH SOC provides clear guidance that specific surgeries can proceed if other conditions are “ “controlled” or “well-controlled” (which in neither case would mean that the condition is altogether gone.) Even a cursory review of the literature suggests that GRS has been performed with successful outcomes in a wide variety of adult individuals, ranging in age from young to elderly, in different parts of the world, and with a variety of other health and mental health conditions. Consistently what appears to improve outcomes is appropriate diagnosis and assessment, in a patient-engaged process that identifies treatment and procedures that match both the particular experience of gender dysphoria and the individual’s situated social and medical life circumstances. The WPATH Standards of Care clearly outline this process.

Moreover, given the refusal by CMS to reconsider and address the previous NCD, despite well-documented formal requests for review starting as early as the 1990’s, the proposed decision’s reference to “low number of clinical studies specifically about Medicare beneficiaries’ health outcomes” as a key deciding factor seems akin to a cynical Catch-22: such studies could not take place until the NCD was removed or modified!

In light of the medical evidence that is available and the consensus of major medical associations regarding transition-related care, we believe the final decision should include the following points:

• The established medical consensus is that GRS is a safe, effective, and medically necessary treatment for many individuals with gender dysphoria, and for many individuals with severe dysphoria, it is the only effective treatment. Previous HHS findings support this consensus.
• The Standards of Care (SOC) maintained by the World Professional Association for Transgender Health (WPATH) satisfies Medicare’s “reasonable and necessary” criterion for determining GRS coverage on a case-by-case basis. Individual cases clearly documenting appropriate diagnosis and assessment following the WPATH SOC will be presumptively approved for coverage.
• Many private and public health plans across the USA now coverage GRS, and most insurance carriers across the USA have issued medical policy guidance that follows the WPATH SOC in eligibility and coverage decisions.
• Widespread coverage exclusions regarding this care including the longstanding CMS NCD 140.3, many of which were lifted only recently, have not only limited access for decades to surgical interventions by transgender individuals who needed them, but have had many other far-reaching consequences. Since paid-claims data is the source for much health outcomes research, these exclusions drastically limited the extent of research regarding GRS, including the full scope of surgical procedures that are now regarded as medically necessary components for gender transition. The exclusions limited patient access and therefore functional “demand,” leading to a drastically reduced provider base and lack of interest in training new providers. The exclusions themselves underpinned and underscored the belief that the condition was fictional and treatment was unnecessary, fueling stigma against transgender individuals and the providers who continued to serve them, leading to near-zero funding levels for transgender health-related research.

The final decision should also take care to clearly address the following concerns:

• The scope of the proposed decision is unnecessarily broad and will likely lead to the unintended consequence of restricting access to coverage for transgender Medicare beneficiaries and other transgender individuals.
• The decision must reflect that other legal standards beyond the NCD process—particularly the nondiscrimination protections codified in Section 1557 of the Affordable Care Act—also apply to Medicare coverage for GRS and other care related to gender transition.
• More research is needed on the health care needs of transgender individuals, but a Medicare coverage protocol that supports “coverage with evidence development” is inappropriate and inadvisable at this time.

Many of these concerns have been well-articulated in a letter by numerous experts and organizations, including the ACLU, Center for American Progress and WPATH, to name a few. We generally support their comment, and have reproduced their discussion and citations below our signature.

Conclusion

Thank you again for your dedication to the health and wellbeing of transgender individuals and for your invitation to provide public comment on the proposed NCD decision. We strongly support CMS in clarifying the degree to which GRS and other care related to gender transition is available under Medicare and appreciate your concern for doing so in a way that does not hinder access to medically necessary care in a discriminatory manner or conflict with previous HHS findings on this matter. We look forward to continuing to work with you to ensure that the final decision is appropriate in scope and clear that coverage for GRS and other care related to gender transition is available under Medicare despite the lack of an NCD. Please do not hesitate to contact me at Jamison Green & Associates with any questions or concerns about these comments.

Sincerely Yours,

André Wilson
SeniorAssociate
Jamison Green & Associates

Detailed Discussion

The established medical consensus is that GRS is safe, effective, and medically necessary for some individuals with gender dysphoria, and for some individuals with severe dysphoria, it is the only effective treatment.

A transgender person is an individual whose gender identity or expression is different from the sex they were assigned at birth. According to 2016 estimates, there are at least 1.4 million transgender people living in the United States.[2] Like anyone, transgender individuals need preventive care to stay healthy and acute care when they become sick. Unfortunately, transgender individuals frequently face barriers to quality health care, such as harassment in health care settings, substandard care, and outright refusals of care.[3] As a result of these barriers and other forms of discrimination, the transgender population as a whole experiences significant health disparities that include high incidence of HIV infection, elevated tobacco and other substance use, frequent exposure to abuse and violence, and a prevalence of suicidal ideation almost nine times higher than among the non-transgender population.[4]

Many transgender people need medical treatment to help them physically transition from their assigned birth sex to the sex with which they identify. The medical diagnosis that is frequently associated with a need for this treatment is “gender dysphoria,” which refers to the clinically significant distress experienced by transgender individuals as a result of a profound misalignment between their gender identity and their assigned sex at birth. Gender dysphoria is described in the fifth edition of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM-5)[5] and is recognized as a serious medical condition by the World Health Organization[6] and every U.S. court that has considered the question.[7] According to the standards of care maintained by the World Professional Association for Transgender Health (WPATH), treatment for gender dysphoria may include gender reassignment surgeries, hormone therapy, and mental health counselling, though the WPATH standards emphasize that treatment must be individualized for each patient on the basis of their clinical history and the judgment of their health care provider.[8] Major medical associations—including the American Medical Association, the American Psychological Association, the American Psychiatric Association, the American Academy of Family Physicians, the Endocrine Society, and the American Congress of Obstetricians and Gynecologists, among others—agree that treatment for gender dysphoria is medically necessary and call for public and private coverage of transition-related care including necessary surgeries.[9]

In a 2008 resolution, for example, the American Medical Association affirmed that mental health counselling, hormone therapy, and GRS are effective, safe, and medically necessary treatments for individuals diagnosed with gender dysphoria.[10] The resolution further emphasizes that, without appropriate medical treatment, gender dysphoria can have consequences that include “clinically significant psychological distress, dysfunction, debilitating depression and, for some people without access to appropriate medical care and treatment, suicidality and death.”[11] As such, access to treatment for gender dysphoria, including GRS, is frequently a matter of life or death for transgender individuals.

Previous HHS findings support this consensus and indicate that the WPATH Standards of Care can satisfy Medicare’s “reasonable and necessary” criterion for determining GRS coverage on a case-by-case basis.

Previous findings from the HHS Departmental Appeals Board (DAB) have already determined that a widespread medical consensus has established GRS as a “reasonable and necessary” treatment for gender dysphoria in appropriate cases.

In May 2014 the DAB invalidated NCD 140.3, which denied Medicare coverage of all “transsexual surgery,” on the grounds that it was based on an outdated record from 1981 that was not complete or adequate to support the determination that transsexual surgery had not been shown to be effective.[12] In its ruling, the DAB cited expert testimony stating that “there are numerous long-term follow-up studies on surgical treatment demonstrating that surgeries are effective and have low complication rates,”[13] and noted that CMS did not challenge this testimony.[14]

The ruling also stated that, contrary to the NCD’s assertion that GRS is “experimental” and “controversial,” current evidence “indicates a consensus among researchers and mainstream medical organizations that transsexual surgery is an effective, safe and medically necessary treatment for transsexualism.”[15] The DAB noted that CMS guidance to contractors indicates that such a consensus may be sufficient to establish that a particular treatment is reasonable and necessary for purposes of Medicare coverage: “While the guidance states a ‘preference’ for ‘[p]ublished authoritative evidence derived from definitive randomized clinical trials or other definitive studies…,’ it also includes as evidence meeting that standard, ‘[g]eneral acceptance by the medical community (standard of practice), as supported by sound medical evidence….’”[16] According to the ruling, “[r]egardless of whether the new evidence here meets the first option for meeting the evidentiary standard set forth in the guidance (and CMS does not assert that it does not), it clearly meets the second option.”[17]

In January 2016 the HHS Medicare Appeals Council (“the Council”), which is part of the DAB, issued a ruling that a Medicare Advantage plan’s decision to deny coverage for GRS to a transgender Medicare beneficiary did not comport with Medicare’s “reasonable and necessary” criterion.[18] In its ruling, the Council echoed the 2014 DAB ruling in noting that the WPATH Standards of Care have “attained widespread acceptance” and emphasized that both the plan and the enrollee’s physicians had recognized the “authority” of the WPATH Standards.[19] The Council therefore concluded that these standards are “reasonable guidelines to determine medical necessity in this case”[20] and found that, inasmuch as the enrollee “satisfies all of the WPATH clinical requirements for gender reassignment surgery…the requested vaginoplasty is medically reasonable and necessary for treatment of this enrollee’s gender dysphoria under Section 1862(a)(1)(A) of the [Social Security] Act and is covered under existing CMS guidance.”[21]

Though this case involves only one individual, the Council expressly frames its ruling as an example of how it will adjudicate claims for GRS on a case-by-case basis in the absence of an NCD.[22] Furthermore, inasmuch as the Council’s ruling in this case constitutes a statement of HHS’s opinion on the “widespread acceptance” of the WPATH Standards and the degree to which its guidelines for GRS can satisfy Medicare’s “reasonable and necessary” test, this ruling and its approach to the WPATH Standards deserve significant deference. We therefore strongly urge CMS to state in the decision or in other guidance to Medicare contractors, as well as to Medicare Advantage plans and Medicare providers, that previous HHS findings on this issue indicate that the WPATH Standards of Care are reasonable guidelines to use in determining medical necessity and coverage for GRS on a case-by-case basis.

The scope of the proposed decision is unnecessarily broad and will lead to the unintended consequence of restricting access to coverage for transgender Medicare beneficiaries and other transgender individuals.

We are concerned that the proposed decision adopts an unnecessarily broad scope that could be read as a statement that Medicare does not cover GRS procedures for the treatment of gender dysphoria. Such an interpretation would be out of step with the previous HHS findings that GRS is “reasonable and necessary” in appropriate cases, and it will also negatively affect the health and wellbeing of transgender Medicare beneficiaries.

The proposed decision states that “CMS evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service is reasonable and necessary.” We do not believe that this is an appropriate framing of the question in light of the DAB’s existing ruling that the medical consensus—by itself—is sufficient to establish that GRS is reasonable and necessary. Rather, the only question before CMS is whether the evidence is of sufficient quality to support a finding that an NCD is the most appropriate means of providing GRS to Medicare recipients with gender dysphoria. We agree with the conclusion that an NCD is not warranted at this time and that “[t]he case-by-case model affords more flexibility to consider a particular individual’s medical condition than is possible when the agency establishes a generally applicable rule.”[23] The scope of the proposed decision, however, substantially exceeds the specific question of whether an NCD is the most appropriate method of providing GRS to Medicare beneficiaries with gender dysphoria.

We have no doubt that CMS intended the broad scope of its analysis to help advance the field of transgender medicine by highlighting areas in need of additional research. However, in presenting a sweeping assessment of studies looking at the entire transgender population—and in drawing conclusions on the basis of an analysis that we believe has serious flaws—the proposed decision reads as a repudiation of GRS as an effective treatment for any transgender individual.

The breadth of this assessment is not required by the laws governing the NCD process. Under 42 U.S.C. 1395y(l)(3)(C) and guidance published at 78 Fed. Reg. 48164-01 (Aug. 7, 2013), a final decision memo must include only (a) summary of public comments and response to those comments, and (b) the scientific basis of CMS’s coverage determination. There is thus no requirement for the decision to include any information or analysis that is not directly relevant to explaining the “scientific basis” for CMS’s ultimate decision. In fact, including extraneous information could be actively misleading by giving the impression that the extraneous information also informed the “scientific basis” for the decision. If CMS determines that none of the studies for a given medical procedure provide sufficient analysis of the Medicare population, there is no basis for providing additional information, analysis, or critiques about other aspects of the relevant studies.

Similarly, there is no need to include information, analysis, or critiques about all studies relating to a medical condition if those studies do not strictly form the basis for evaluating the effectiveness and safety of the procedure in question. As such, we strongly urge you to limit the scope of the decision to noting that a preponderance of the available evidence specific to GRS does not include the Medicare population. In this situation, the conclusion should be that an NCD is not warranted at this time because it is more appropriate to continue to assess the medical necessity of GRS procedures for Medicare beneficiaries on an individual basis, with guidance from the WPATH Standards or other relevant expert standards in the field of transgender medicine.

In addition to overgeneralizing from the lack of information available about the Medicare population, the proposed decision also fails to make clear distinctions between GRS and other treatments for gender dysphoria, such as hormone therapy. The proposed decision notes in passing merely that “the specific role for various surgical procedures is less well understood than the role of hormonal intervention,” without any further clarification that the decision applies only to surgical procedures. While we are aware that CMS intentionally focused this analysis on GRS, the lack of any other guidance from CMS about Medicare coverage for care related to gender transition makes it very likely that this proposed decision will be interpreted as the definitive statement of what Medicare does or does not cover. Given the decision’s broad dismissal of the evidence related to GRS and its relative silence about any other aspects of transition-related care, we are deeply concerned that the decision will be used as evidence that Medicare does not cover any care related to gender transition—with predictable consequences not only for transgender Medicare beneficiaries but also those with coverage from other payers.

CMS indicates that the purpose of the proposed decision is to maintain the status quo regarding the availability of coverage for gender reassignment under Medicare. This perspective, however, fails to address the fact that the status quo for many transgender Medicare beneficiaries is a lack of coverage. A moderated online group for transgender Medicare beneficiaries with more than 2,600 members, for example, provides numerous examples of denials, confusion, and misinformation related to what Medicare covers for care related to gender transition:[24]

• “I’m so upset with Medcare [sic] until I’m ready to just die, I found out that it will not pay for my Top surgery, not [sic] matter how much I try it seems that I’m always hitting this da*n wall…I’m so tired of hitting that wall. So now I sit here crying and trying to think what to do, and I’m about to my witts [sic] end.” (October 2015)
• “The surgeon replied to my request: Jaime in our insurance department called Medicare and this is what they said—National Coverage Determination is no longer valid, an appeal invalidated the coverage for transgender surgery. They have no idea when it might be reinstated. So with that being said there’s no way we can submit this as gender reassignment. It will get denied and you will be responsible for everything.” (November 2015)
• “Got a call from [hospital]. Surgeries are on hold. They have not been paid from four cases. They are in the process of trying to figure things out with Medicare. Not the best news for me.” (December 2015)
• “The reason [for denial of bilateral mastectomy/chest reconstruction for a transgender man] is that the surgeons know that there is no National Coverage Determination, i.e. written policy on the part of Medicare. There hasn’t been one since the ban was dropped…many surgeons are waiting for written policy.” (April 2016)
• “I am disabled and on SSDI with Medicare. While I am fortunate to have had a career that puts me on the upper ranges of SSDI, and my wife works (17 years and she is just getting to $13 an hour) we don’t have the kind of money we can throw at electrolysis for a surgical site on me. It’s a prerequisite for surgery, there are no Medicare billing electrolysis technicians who I’ve found, and it’s a lengthy process that requires in the $1000’s to complete. If I don’t find a way to get the funding for the electrolysis I very well will be shut off from obtaining the care I need. If I’ve got it bad, I can’t imagine the unobtainable nightmare it must be for those fighting poverty.” (June 2016)

One of the group’s moderators provides the following summary of what he describes as common problems:[25]

• Surgeons can’t get preauthorization, so they won’t schedule surgery. Even though original Medicare pays after the procedure, these surgeons won’t take a chance on Medicare since there is nothing in writing to say Medicare will cover it. They will do it for other established surgeries, but surgeries related to gender reassignment are “taboo.”
• Providers’ offices say that Medicare does not cover transition-related services because they do not know about the 2014 DAB ruling rescinding NCD 140.3.
• Providers refuse to accept Medicare’s low reimbursement rates.
• Providers do not know what codes they need to use to bill Medicare for GRS.
• Transgender Medicare beneficiaries regularly call Medicare’s call center and are told the call center representatives can’t say whether GRS is covered; call center representatives don’t inform callers that procedures are being paid for on a case-by-case basis.

The problem of ongoing denials of coverage for care related to gender transition is not restricted to Medicare. As of June 2016, for instance, 18 state Medicaid programs and 40 (almost 80 percent) of the state-selected Essential Health Benefit (EHB) benchmark plans for 2017 explicitly ban coverage for care related to gender transition.[26] This status quo is changing slowly, but even in the short time the proposed decision has been public, numerous advocacy organizations have received reports of payers and regulators seizing on it as justification for attempts to limit access to transition-related care.[27] While we understand that CMS cannot be responsible for the actions of other payers and regulators, we strongly urge you to ensure that the decision is clearly restricted to the Medicare population and clarifies that coverage for GRS is available under Medicare on a case-by-case basis. We also encourage CMS to publish additional guidance for Medicare contractors, including Medicare Administrative Contractors (MACs), Medicare Advantage plans, Part D prescription drug plans, and providers, clarifying that physician services and prescription drugs related to gender transition—such as mental health counseling and hormone therapy—are broadly considered reasonable and necessary under Medicare guidelines.

The decision must reflect that other legal standards beyond the NCD process also apply to Medicare coverage for GRS and other care related to gender transition.

As mentioned above, though NCD 140.3 was rescinded in 2014, many stakeholders appear to be unaware that Medicare does cover GRS on a case-by-case basis. Similarly, many stakeholders are unaware that Medicare covers services and medications such as mental health counselling and hormone therapy. We are concerned that the decision as currently proposed will encourage Medicare contractors, including MACs, Medicare Advantage plans, Part D prescription drug plans, and providers, to maintain or institute policies that both undermine the health and wellbeing of transgender individuals and violate federal nondiscrimination laws such as ACA Section 1557 by inappropriately denying access to transition-related care.

As you know, ACA Section 1557 prohibits any health program or entity receiving federal funds from discriminating on a variety of bases, including sex. HHS released a final rule in May 2016 clarifying that these sex protections extend to gender identity and sex stereotypes, meaning that they specifically include transgender individuals.[28] The final rule explicitly states that covered entities can no longer categorically exclude all services related to gender transition, and they cannot make coverage decisions in a manner that results in discrimination against a transgender individual—such as denying coverage for mental health services related to gender transition while covering them for depression, among many other examples. The final rule also requires health care providers to provide medically necessary health care services to transgender individuals, as long as those services are within the provider’s scope of practice. Section 1557 applies to all plans sold by any issuer who participates in federal health care programs such as Medicare or federally supported programs such as Medicaid. Covered entities that violate Section 1557’s requirements are potentially subject to both administrative remedies and private lawsuits.

It is beyond the scope of the NCD process and the proposed decision memo to provide substantial guidance to contractors and other Medicare stakeholders on their legal obligations with regard to coverage for gender transition services under Section 1557. We believe, however, that CMS would do these stakeholders a disservice by failing to take the opportunity to reiterate that, in the absence of an NCD, Medicare contractors, Medicare Advantage plans, and Part D prescription drug plans must ensure that they are making coverage determinations in a nondiscriminatory manner. This involves eliminating categorical exclusions for transition-related care, as well as using medical necessity criteria that conform to the latest WPATH Standards of Care or other accepted standards in the field of transgender medicine and that do not inappropriately limit access to health care services for transgender individuals, including GRS and other services related to gender transition.

More research is needed on the health care needs of transgender individuals, but a Medicare coverage protocol that supports “coverage with evidence development” (CED) is inappropriate and inadvisable at this time.

We appreciate CMS’s support for more research regarding the treatment options available to transgender individuals with gender dysphoria. As you know, these treatment options are lifesaving for transgender individuals who need specific health care services to live authentic lives in bodies that reflect their true identity. We agree that more research is needed around the health care needs of transgender individuals and look forward to working with CMS and research entities such as the National Institutes of Health and the Patient-Centered Outcomes Research Institute to enhance the number and quality of studies in the field of transgender medicine.

In the meantime, however, we strongly caution against instituting a CED protocol for Medicare coverage of GRS. While we recognize that CMS policy allows use of the CED process in a wide range of situations,[29] a CED protocol would unnecessarily restrict access to care for transgender individuals. Outcomes research can be conducted without designating only a limited number of sites or providers where treatment can be received. Moreover, despite welcome advances such as the Section 1557 final rule, transgender individuals continue to face widespread discrimination, harassment, and even violence in aspects of everyday life as mundane as trying to access public restrooms. In the health care context, the long history of mistreatment of transgender patients at the hands of medical professionals leads many transgender individuals to be wary of the medical field and sometimes to avoid seeking health care entirely.[30] Potential study participants may thus have well-founded concerns about a policy that makes access to Medicare coverage for transition-related health care contingent on being enrolled in a formal medical research study. While a CED protocol would be a well-intentioned effort to advance the field of transgender medicine, in practice it would raise serious concerns for participants and would severely restrict the availability of lifesaving health care services for transgender individuals.

[1]

[2] Andrew R. Flores et al., Williams Institute, How Many Adults Identify as Transgender in the United States? 2 (2016), http://williamsinstitute.law.ucla.edu/wp-content/uploads/How-Many-Adults-Identify-as-Transgender-in-the-United-States.pdf.

[3] E.g., Lambda Legal, When Health Care Isn’t Caring: Lambda Legal’s Survey on Discrimination Against LGBT People and People Living with HIV (2010), http://www.lambdalegal.org/publications/when-health-care-isnt-caring; Inst. of Med., The Health of Lesbian, Gay, Bisexual, and Transgender People: Building a Foundation for Better Understanding (2011), http://www.iom.edu/Reports/2011/The-Health-of-Lesbian-Gay-Bisexual-and-Transgender-People.aspx.

[4] E.g., Dep’t of Health & Human Servs., Lesbian, Gay, Bisexual, and Transgender Health (2010), http://www.healthypeople.gov/2020/topics-objectives/topic/lesbian-gay-bisexual-and-transgender-health?topicid=25.

[5] Am. Psychiatric Ass’n, Gender Dysphoria in the DSM-5 (2013), http://www.dsm5.org/documents/gender%20dysphoria%20fact%20sheet.pdf.

[6] World Health Org., International Statistical Classification of Diseases and Related Health Problems, http://apps.who.int/classifications/icd10/browse/2010/en#/F64.

[7] See e.g., Farmer v. Brennan, 511 U.S. 825 (1994); Brown v. Zavaras, 63 F.3d 967 (10th Cir. 1995); Maggert v. Hanks, 131 F.3d 670 (7th Cir. 1997); Cuoco v. Moritsugu, 222 F.3d 99 (2nd Cir. 2000); O’Donnabhain v. Comm’r of Internal Revenue Serv., 134 T.C. 34 (U.S. Tax Ct. 2010); Battista v. Clarke, 645 F. 3d 449 (1^st Cir. 2011); Fields v. Smith, 653 F.3d 550 (7^th Cir. 2011); Soneeya v. Spenser, 851 F. Supp. 2d 228 (D. Mass. 2012); Kosilek v. Spencer, No. 00-12455, 2012 U.S. Dist. LEXIS 124758 (D. Mass. Sept. 4, 2012).

[8] World Prof. Ass’n for Transgender Health, Standards of Care for the Health of Transsexual, Transgender and Gender-Nonconforming People (2012).

[9] See Lambda Legal Def. & Educ. Fund, Professional Organization Statements Supporting Transgender People in Health Care (2013), available at: http://www.lambdalegal.org/sites/default/files/publications/downloads/fs_professional-org-statements-supporting-trans-health_4.pdf (chronicling statements from various professional medical associations in support of transgender health needs).

[10] Am. Med. Ass’n House of Delegates, Removing Financial Barriers to Care for Transgender Patients, H-185.950 (Res. 122; A-08) (2008), http://www.tgender.net/taw/ama_resolutions.pdf.

[11] Id.

[12] Dep’t of Health & Human Servs., NCD 140.3, Transsexual Surgery (Docket No. A-13-47) (2013), http://www.hhs.gov/dab/decisions/dabdecisions/ncd1403.pdf.

[13] Dep’t of Health & Human Servs., NCD 140.3, Transsexual Surgery (Docket No. A-13-87), 18 (2014), http://www.hhs.gov/dab/decisions/dabdecisions/dab2576.pdf.

[14] Id.

[15] Dep’t of Health & Human Servs., supra note 13 at *20.

[16] Id. (citations omitted).

[17] Id.

[18] Decision of Medicare Appeals Council, Docket # M-15-1069 (Jan. 21, 2016).

[19] Id. at *9.

Kaiser Permanente appreciates CMS’ consideration of Kaiser Permanente’s comments submitted during the initial comment period on the National Coverage Analysis for Gender Dysphoria and Gender Reassignment Surgery. We respectfully submit these additional comments today in response to CMS’ Proposed Decision Memo for Gender Dysphoria and Gender Reassignment Surgery.

Consistent with our commitment to diversity, inclusion, and delivering culturally competent care to our members, Kaiser Permanente continues to ensure access to high quality, medically appropriate services to address gender dysphoria. Given the widespread disenfranchisement and discrimination experienced by transgender individuals, we urge CMS to establish Medicare coverage guidelines for transgender health services. Gender confirming surgery, which was once seen as experimental, is now widely accepted as the medically necessary standard of care for gender dysphoria, in appropriate cases. Based on this shift, regulators and payers are increasingly requiring insurers to cover a wide range of services for the treatment of gender dysphoria.

While behavioral health services and hormone therapy have long been provided to our members, including those diagnosed with gender dysphoria, Kaiser Permanente began expanding upon those services in early 2013 – adding lower body gender confirming surgery, mastectomy with chest reconstruction, tracheal shave, and facial hair removal for our commercial transgender members in a number of our regions. Kaiser Permanente's national position supports covering surgical and non-surgical services when medically necessary for the treatment of gender dysphoria in all our regions, and we are in the active process of developing and implementing these benefits nationally. Our ultimate vision is to offer consistent medically necessary transgender services to all our members, irrespective of payer or geographic location in 2017.

The absence of coverage guidance for Medicare members is disruptive to organizations that are striving to offer the highest quality health care services to all their members. We believe that a National Coverage Decision by CMS would help ensure that all Medicare beneficiaries have access to the same scope of services regardless of geographic location, while mitigating potential adverse selection issues among Medicare health plans resulting from coverage differences relating to transgender services. Moreover, the recently adopted Final Rule implementing Section 1557 of the Affordable Care Act includes provisions prohibiting discrimination in health care services and coverage based on gender identity. In light of this recent regulatory development, we believe it would be prudent for CMS to issue more concrete guidance with respect to the required scope of covered services for the treatment of Medicare beneficiaries diagnosed with gender dysphoria.

Kaiser Permanente continues to offer our support to CMS and other regulators as we collectively move forward with policy improvements to meet the health care needs of transgender individuals. Kaiser Permanente appreciates CMS’ consideration of these comments.

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Re: Proposed decision memorandum on gender reassignment surgery for Medicare beneficiaries with gender dysphoria (Administrative File CAG #00446N)

Dear Ms. Syrek Jensen,

On behalf of the American Psychological Association (APA), we are writing to comment on the proposed decision memo regarding whether the Centers for Medicare & Medicaid Services (CMS) should issue a new National Coverage Determination (NCD) regarding gender reassignment surgery (GRS). Like the Administration, we believe that all Medicare beneficiaries, including transgender individuals, should have access to high-quality coverage and care, and we appreciate your attention to this issue.

APA previously provided comments in support of a national coverage determination to ensure equity and the best quality care for gender dysphoria. We are concerned that the recent decision is a step backward to ensuring equitable and quality care for gender dysphoria and may actually limit treatment options and deleterious effects on mental health of transgender individuals. We have concerns regarding the analysis that CMS cites to support this conclusion and the degree to which the memo as currently written will undermine access to coverage for medically necessary health care services for transgender individuals, including transgender Medicare beneficiaries. As such, we respectfully urge you to revise the memo to clarify Medicare’s stance on coverage to ensure access to medically necessary care. APA is committed to the health of transgender individuals and the appropriate treatment of gender dysphoria and would assist in anyway in this revision process.

APA is the largest scientific and professional organization representing psychology in the United States, with more than 122,500 researchers, educators, clinicians, consultants, and students as its members. APA has a strong commitment to improving the health and well-being of gender minority individuals, the practice of psychology, and the provision of healthcare. APA has made the psychological and health needs of transgender and gender diverse people a high priority. Psychological research can inform treatment, service provision, civil rights and approaches to promoting the well-being of transgender and gender diverse individuals across the lifespan. Gender dysphoria - clinically significant and persistent distress or impairment caused by a marked difference between the individual’s expressed/experienced gender and the gender others would assign him or her (American Psychiatric Association, 2013b) - has been identified by the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition as a disorder that warrants mental and physical health treatments as determined by licensed health providers. For those individuals with gender dysphoria behavioral and medical interventions can reduce distress and improve adjustment and coping.

APA supports the best possible care for gender dysphoria including the full range of gender transition services across the lifespan, including gender reassignment surgery (GRS). APA’s support for this coverage determined is strengthened by professional and scientific evidence that transgender and other gender variant people benefit from treatment with health care providers with specialized knowledge of their issues and these include both medical and surgical services as well as behavioral health and social supports (APA, 2015ab; Lurie, 2005; Rachlin, 2002). We share the concerns expressed by a variety of health care providers that the scientific review may be insufficient and may be ultimately harmful as a reference for insurers. Rather, we urge the use of professional guidelines from World Professional Association for Transgender Health (WPATH), which can be used to determine the “reasonable and necessary” criterion for determining GRS coverage on a case-by-case basis. APA publications can also clarify appropriate psychological assessment and treatment services for gender dysphoria, especially in determining what types of treatment may be medically necessary. We believe the professional guidelines provide safe and effective treatment for gender dysphoria that reflect the best existing science and health professional consensus.

APA also urges coverage of these services because of a long history of health discrimination and health disparities experienced by gender nonconforming individuals. For example, APA’s policy Transgender, Gender Identity, &Gender Expression Non-Discrimination (2015b) identifies gaps in the treatment of gender dysphoria and points out the lack of appropriate health care resources for transgender adults and youth, including the lack of gender transition services across the lifespan. For example, persons with gender dysphoria may be denied appropriate gender transition related physical and mental health care despite evidence that these treatments are efficacious and beneficial (De Cuypere et al., 2005; Kuiper & Cohen-Kettenis, 1988; Newfield, et al., 2006; Pfafflin & Junge, 1998; Rehman et al., 1999; Ross & Need, 1989; Smith et al., 2005). Transgender individuals disproportionately report income below the poverty line (APA, 2007; Grant et al., 2011) and experience other financial disadvantages (Lev, 2004). Older adults and other individuals living on limited, fixed incomes are not able to meet the expenses associated gender-affirming transition services. Thus, treatment coverage by Medicare and by private and public payers is even more essential if behavioral and physical health needs are to be met and existing disparities are to be addressed.

If you have any questions or need additional information from APA, please contact Judith Glassgold, PsyD, Associate Executive Director for Government Relations in the Public Interest Directorate. (202- 336-6104; jglassgold@apa.org).

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July 1, 2016

Tamara Syrek-Jensen, JD
Director, Coverage and Analysis Group, CCSQ
Centers for Medicare & Medicaid Services
7500 Security Blvd. C1-14-15
Baltimore, MD 21244

Dear Ms. Syrek-Jensen:

The San Francisco Department of Public Health (SFDPH) would like to express disappointment with the Proposed Decision Memorandum on Gender Reassignment Surgery for Medicare Beneficiaries with Gender Dysphoria.

CMS's analysis of the evidence has determined that Medicare patients are not reflective of the patients represented in the literature. We respectfully disagree. SFDPH's Transgender Health Services program has been providing access to genital surgery for Medicare-Medicaid dual-eligibles. Our staff are on the front lines providing care for the very population CMS is concerned may not benefit from gender confirmation surgery.

SFDPH's Transgender Health Services can provide you experience and testimonials; our experience mirrors the existing outcomes research. However, we are unable to engage in the type of research you require. We cannot do randomized control trials, denying medically necessary care for the sake of research or offer people just one intervention when we know more than one is needed. Further, people are coming for medical care after a lifetime of trauma caused by the medical and mental health system and not signing up for a research trial. They want to get their healthcare and live their lives - not be the object of study.

The requirement for more robust data is complex because transgender people are a population where access to medically necessary care has been discouraged, contributing to the lack of evidence and the inadequacies of data collection. Both of these issues have been documented by the Institute of Medicine and Healthy People 2020. Care for transgender people is highly individualized and involves a variety of interventions and not each individual consumer needs the same set of interventions. As CMS noted, less than .05% of the population identify as transgender. In a small population that needs highly individualized care, statistically, this would constitute multiple factors and there isn't enough power to detect the impact of each intervention individually.

We are very familiar with the literature and for example, would like to focus on one of the studies CMS used to deny the NCD. Cecilia Dhjene, the author of the study herself says that the data should not be used in the manner that CMS used the data. On June 21, 2016, that same researcher presented data explaining what providers already knew about the morbidity and mortality reported in her research. People who are abused as children or bullied and tormented have mental health problems. Gender Confirmation surgery can reduce dysphoria but it cannot be expected to alter the impact of toxic stress from childhood, which the CDC knows causes mental and physical health problems. CMS interpretation of this study conflates these issues. Further, gender confirmation surgery treats gender dysphoria not discrimination. We have no way of knowing that a person's situation would not have been worse without surgery and it would be unethical to deny care to people just to answer that question when we already have experience that it does improve the quality of Medicare beneficiaries' lives.

We are gravely concerned that your analysis will negatively affect Medicare beneficiaries, and has the potential to harm all transgender people accessing medically necessary care. We encourage CMS to reexamine the data with content experts and professional organizations such as the World Professional Association for Transgender Health, the American Psychological Association, the American Congress of Obstetricians and Gynecologists, and others. We would suggest that CMS fund an effort to reanalyze the data in a meta-analysis of the existing studies since it is such a small and heterogeneous population.

Thank you for the opportunity to comment.

Sincerely,

/s/
Barbara A. Garcia, MPA
Director of Health

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June 30, 2016

Tamara Syrek Jensen, JD
Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd. C1-14-15
Baltimore, MD 21244

Re: Proposed Decision Memo for Gender Dysphoria and Gender Reassignment Surgery (CAG-00446N)

Dear Ms. Syrek-Jensen:

On behalf of the physician and medical student members of the American Medical Association (AMA), I appreciate the opportunity to provide comments on the Proposed Decision Memorandum (PDM) for Gender Dysphoria and Gender Reassignment Surgery issued by the Centers for Medicare & Medicaid Services (CMS).

The AMA recognizes that medical and surgical treatments for gender dysphoria, as determined by shared decision making between the patient and physician, are medically necessary as outlined by generally-accepted standards of medical and surgical practice, and thus we support public and private health insurance coverage for treatment of gender identity disorder dysphoria as recommended by the patient's physician. Our position is based on the recognition that gender dysphoria is a condition recognized by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5, 2013), published by the American Psychiatric Association. Also, Standards of Care established by the World Professional Association for Transgender Health—the leading international, interdisciplinary professional organization devoted to the understanding and treatment of gender dysphoria—recognizes that while patients’ needs differ and treatment decisions should be individualized, for some individuals “relief from gender dysphoria cannot be achieved without modification of their primary and/or secondary sex characteristics to establish greater congruence with their gender identity.”

While the AMA agrees with CMS’ decision not to issue a National Coverage Determination (NCD) at this point on gender reassignment surgery for Medicare patients, we are concerned that the analysis of the scientific literature presented in the recent PDM could be used in unintended ways, including as justification by public and private insurers to deny coverage for transgender-related surgeries. Such a result would be contrary to the AMA’s support for the removal of barriers for the treatment of transgender individuals, including transition-related surgeries.

The AMA urges CMS to conduct a re-examination of the literature it reviewed in developing the PDM. We recommend that CMS conduct this review in consultation with experts in the field of transgender health and transition-related surgeries. Furthermore, we urge CMS to include in a revised PDM an explicit statement that, while CMS declines to issue an NCD on Gender Reassignment Surgery at this time, the proposed decision should not be taken to mean that CMS feels there is no evidence to support transgender surgical treatment. CMS should make clear in a revised PDM that Medicare coverage for transition-related surgeries would still be available on a case-by-case basis by local carriers and that nothing in its analysis should be construed as justification to deny coverage for transition-related surgeries in other contexts. Moreover, CMS should state as a justification for not issuing an NCD that there simply is not enough evidence at this time to state which particular surgical techniques should be covered.

Thank you for considering the AMA’s comments. We look forward to working with CMS on this important issue. If you have any questions, please contact Margaret Garikes, Vice President of Federal Affairs, at 202-789-7409 or margaret.garikes@ama-assn.org.

Sincerely,

James L. Madara, MD

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Gender Confirmation Surgery (also known as Gender Reassignment Surgery or Sex Reassignment Surgery) is medically necessary for trans people, e.g. those with a diagnosis of gender dysphoria. The medical community is overwhelming in their support for this fact. Those on Medicare and Medicaid should have full access to this life-saving - not to mention life-affirming - surgery. Please issue a National Coverage Determination (NCD) to reflect this. It will be looked on well in history and will help so many deserving patients whom doctors find eligible for these critical procedures.

Pleaser note that I am a cis (non-trans) person with trans loved ones. It's for them that I submit this comment. For cis people, it's easy to assume that GCS (GRS) is cosmetic, but the medical literature - not to mention accounts from trans people themselves - overwhelmingly shows it's not. I know you may have small sample sizes of Medicare beneficiaries in particular, but there is no reason that they should fare differently than the general population. Indeed, my activism on this topic includes that to mandate fully trans-inclusive coverage of all private insurers as well, as I believe that not doing so amounts to nothing less than discrimination on the basis of transgender status (and is not nearly as expensive as the cis majority assumes given the numbers of trans people as a percentage of the population). Thank you.

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As a professional educator and advocate who has a ten year history of working with youth and adult transgender individuals, I absolutely agree that medicare needs to cover GCT (gender confirmation treatment), that empowering individuals to have a physical body that matches their gender identity is essential to quality of life as one ages.

Not all transgender people seeking medical intervention for gender dysphoria find themselves able to transition socy or physically before age 62 due to risk of job loss, family rejection, and fear of pension loss.
Due to increasing discrimination against transgender individuals in schools and in employment, esp for transwomen, the ability to cover otherwise expensive surgeries and often fly around the world or miss weeks of work is limited for most.

So please, do like the City of San Francisco did and put a moderate amount of moneu aside then realize the majority of the funds will go unused and be able to be allocated for some of the other issues facing transgender seniors, such as hearing loss and mobility loss.
Gender dysphoria for many is a very serious medical condition which deeply affects some trans folks but not all. Not all trans folks want or need or can have invasive surgeries, and some just take very lowcost hormones.

If you can help an individual and system save millions on the results of a lack of treatment such as mental health issues, hospitalizations, addiction treatment, melessness, joblessness and lack of community as we age, your work will be well-respected. Many opponents fear too much money will be spent on transgender individuals seeking medical care but most have no idea what that care looks like or costs.

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AAFP American College of Family Physicians
In 2007, an AAFP Commission declared that the association has a policy opposing any form of patient discrimination and stated its opposition to the exclusion of transgender health care: “RESOLVED, That the American Academy of Family Physicians endorse payment by third party payors to provide transsexual care benefits for transgender patients.” http://www.aafp.org/dam/AAFP/documents/about_us/special_constituencies/2012RCAR_Advocacy.pdf

ACOG American College of Obstetricians and Gynecologists
“Transgender individuals face harassment, discrimination, and rejection within our society. Lack of awareness, knowledge, and sensitivity in health care communities eventually leads to inadequate access to, underutilization of, and disparities within the health care system for this population. Although the care for these patients is often managed by a specialty team, obstetrician-gynecologists should be prepared to assist of refer transgender individuals with routine treatment and screening as well as hormonal and surgical therapies. The American College of Obstetricians and Gynecologists opposes discrimination on the basis of gender identity and urges public and private health insurance plans to cover the treatment of gender identity disorder.” http://www.acog.org/Resources_And_Publications/Committee_Opinions/Committee_on_Health_Care_for_Underserved_Women/Health_Care_for_Transgender_Individuals

ACP American College of Physicians, calls for clinical LGBT competency recognizing disparency of care http://annals.org/article.aspx?articleid=2292051

AMA American Medical Association
http://www.imatyfa.org/wp-content/uploads/2013/06/ama_resolution_122.pdf
“An established body of medical research demonstrates the effectiveness and medical necessity of mental health care, hormone therapy and sex reassignment surgery as forms of therapeutic treatment for many people diagnosed with GID … Therefore, be it RESOLVED, that the AMA supports public and private health insurance coverage for treatment of gender identity disorder.”
http://www.tgender.net/taw/ama_resolutions.pdf

AMSA American Medical Student Association, issues guidance for care of transgender patients http://www.amsa.org/advocacy/action-committees/gender-sexuality/transgender-health/

APA American Psychology Association
As stated in the Policy on Transgender, Gender Identity & Gender Expression NonDiscrimination,the APA “opposes all public and private discrimination on the basis of actual or perceived gender identity and expression and urges the repeal of discriminatory laws and policies” and “calls upon psychologists in their professional roles to provide appropriate, nondiscriminatory treatment to transgender and gender variant individuals and encourages psychologists to take a leadership role in working against discrimination towards transgender and gender variant individuals[.]” The “APA recognizes the efficacy, benefit and medical necessity of gender transition treatments for appropriately evaluated individuals and calls upon public and private insurers to cover these medically necessary treatments.” http://www.apa.org/news/press/releases/2008/08/gender-variant.aspx

APA guidelines
http://www.apa.org/practice/guidelines/transgender.pdf

AAFP American Academy of Family Physicians (resolutions 1002-1006)
http://www.aafp.org/dam/AAFP/documents/about_us/special_constituencies/2012RCAR_Advocacy.pdf

APHA American Public Health Association
The APHA issued a policy statement concluding that “transgendered individuals are not receiving adequate health care, information, or inclusion within research studies because of discrimination by and/or lack of training of health care providers and researchers; therefore…” The APHA thus “Urges researchers and health care workers to be sensitive to the lives of transgendered individuals and treat them with dignity and respect, and not to force them to fit within rigid gender norms. This includes referring to them as the gender with which they identify; Urges researchers, health care workers, the National Institutes of Health, and the Centersfor Disease Control and Prevention to be aware of the distinct health care needs of transgendered individuals; and Urges the National Institutes of Health and the Centers for Disease Control and Prevention to make available resources, including funding for research, that will enable a better understanding of the health risks of transgendered individuals, especially the barriers they experience within health care settings…” http://www.apha.org/policies-and-advocacy/public-health-policy-statements/policy-database/2014/07/29/09/18/the-need-for-acknowledging-transgendered-individuals-within-research-and-clinical-practice

HHS U.S. Department of Health and Human Services, released guidelines 5/14/16
“The final rule helps consumers who are seeking to understand their rights and clarifies the responsibilities of health care providers and insurers that receive federal funds. The final rule also addresses the responsibilities of issuers that offer plans in the Health Insurance Marketplaces. Among other things, the final rule prohibits marketing practices or benefit designs that discriminate on the basis of race, color, national origin, sex, age, or disability. The final rule also prohibits discriminatory practices by health care providers, such as hospitals that accept Medicare or doctors who participate in the Medicaid program.”
http://www.hhs.gov/about/news/2016/05/13/hhs-finalizes-rule-to-improve-health-equity-under-affordable-care-act.html

NASW National Association of Social Workers
“NASW supports the rights of all individuals to receive health insurance and other health coverage without discrimination on the basis of gender identity, and specifically without exclusion of services related to transgender or transsexual transition…in order to receive medical and mental health services through their primary care physician and the appropriate referrals to medical specialists, which may include hormone replacement therapy, surgical interventions, prosthetic devices, and other medical procedures.” https://www.socialworkers.org/da/da2008/finalvoting/documents/Transgender%202nd%20round%20-%20Clean.pdf

NCCH National Commission on Correctional Healthcare
“The health risks of overlooking the particular needs of transgender inmates are so severe that acknowledgment of the problem and policies that assure appropriate and responsible provision of health care are needed… Because prisons, jails, and juvenile justice facilities have a responsibility to ensure the physical and mental health and well-being of transgender people in their custody, correctional health staff should manage these inmates in a manner that respects the biomedical and psychological aspects of a gender identity disorder (GID) diagnosis.” http://www.ncchc.org/filebin/Positions/Transgender-Transsexual-and-Gender-Nonconforming-Health-Care.pdf

PA Phycological Association of Ohio's statement on ending conversion therapy http://www.ohpsych.org/about/2016/02/13/ending-conversion-therapy-statement/

WPATH World Professional Association of Transgender Health, WPATH found that decades of experience with the Standards of Care show gender transitions and related care to be accepted, good medical practice and effective treatment. In a 2008 clarification, WPATH stated: “Sex reassignment, properly indicated and performed as provided by the Standards of Care, has proven to be beneficial and effective in the treatment of individuals with transsexualism, gender identity disorder, and/or gender dysphoria. Sex reassignment plays an undisputed role in contributing toward favorable outcomes, and comprises Real Life Experience, legal name and sex change on identity documents, as well as medically necessary hormone treatment, counseling, psychotherapy, and other medical procedures...The medical procedures attendant to sex reassignment are not ‘cosmetic’ or ‘elective’ or for the mere convenience of the patient. These reconstructive procedures are not optional in any meaningful sense, but are understood to be medically necessary for the treatment of the diagnosed condition.” http://www.wpath.org/site_page.cfm?pk_association_webpage_menu=1352&pk_association_webpage=3947

WMA World Medical Association http://www.wma.net/en/40news/20archives/2015/2015_36/index.html

WHO world health organisation, document explaining social inequality concerning access to health care and the detriment to health http://www.euro.who.int/__data/assets/pdf_file/0005/98438/e81384.pdf

a joint letter from the APA, APSPA, NASW, and AAPCSW "The nation’s leading mental health professional organizations are expressing dismay over the spate of recent bills and laws that would allow for individuals and businesses to deny services, employment and housing to LGBT people under the guise of religious freedom. Studies confirm that discrimination, bias and prejudice have negative consequences on one’s mental health and overall well-being. Specifically, research has linked anti-LGBT discrimination to increased risk of depression, anxiety and substance use. And studies show that lesbian, gay and bisexual youth are up to six times more likely to attempt suicide while 41 percent of transgender people report having made a suicide attempt. It is important to note that several studies also show marked increases in overall physical and mental health when governments enact laws and policies, such as the executive orders recently signed by Pennsylvania Gov. Tom Wolf that strengthen equality for LGBT people. Community and family acceptance has also been shown to contribute significantly to fewer occurrences of depression, anxiety and suicidality for LGBT youth. Our organizations have strong ongoing commitments to promote the health and well-being of LGBT adults and youth; to eliminate violence against LGBT people; and to support full equality in areas such as marriage, employment, housing, public accommodation, military service, licensing, parenting, adoptions and access to legal benefits. We urge states to reject these harmful and discriminatory bills and to repeal such laws that have already passed." http://www.apsa.org/sites/default/files/Joint_Statement_Religious_Freedom_Laws_0.pdf

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It is vital the CMS adopt universal coverage standards for Transgender Americans who are on Medicaid & Medicare. Gender dysphoria is disableing and gender assignment surgery is the life saving medical treatment to combat this medical condition. By treating gender dysphoria with Hormone replacement therapy AND gender reassignment surgery, CMS will be empowering transgender americans, by treating their crippling gender dysphoria and allowing them to regain mental and physical health so they can in turn go out into the work force, be a productive member of society, and pay into Medicare and Medicaid.

Most of the civilized world's countries already cover treatment for gender dysphoria—Canada, UK, Switzerland, etc. They do this because they understand that Gender Dysphoria is just as deadly as certain cancers, and needs to be treated just as you cover other disease treatments.

Please make coverage universal for treating gender dysphoria by making coverage universal for Gender Reassignment Surgery and Hormone replacement therapy.

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June 2016

James Rollins, MD
Director, Division of Items and Services
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD, 21244

Dear Dr. Rollins,

Please allow this letter to show support for comprehensive gender-affirming healthcare coverage at the Center of Medicare and Medicaid Services (CMS). Transgender and gender nonconforming (TGNC) people are those who have a gender identity that is not aligned with their sex at birth (American Psychological Association (APA), 2015). I am a doctoral student in clinical psychology at Adler University who is working with the TGNC community both clinically and through research.

APA has stated that they oppose all public and private discrimination on the basis of actual or perceived gender identity and expression, urged the repeal of discriminatory laws and policies, and supported the passage of laws and policies protecting the rights, legal benefits, and privileges of people of all gender identities and expressions (APA, 2015; Anton, 2009). A particularly vulnerable population that is affected by lack of gender-affirming coverage is transgender youth. Adolescents presenting with persisting Gender Dysphoria (GD) are more prone to psychological distress and mental illness after the irreversible effects of puberty, and consequently throughout their lifetime. Children entering puberty with persisting GD are likely to become psychologically distressed as they develop unwanted secondary sex characteristics of their natal gender, and this can lead to the onset of severe anxiety, depression, and suicidal ideation (Drescher & Byne, 2012; Shumer & Spack, 2013; Tishelman et al., 2015).

The APA has made the psychological and other health needs of transgender and gender diverse people a high priority; moreover, the APA has strongly supported the development of CMS coverage to ensure that adults, children, and youth receive the best possible care for GD, which includes a full array of gender-affirming and gender transitions services across the lifespan (Glassgold, 2015). Leaders in the field agree with the contemporary treatment of GD in youth. For example, Robert H. Lurie Children’s Hospital of Chicago has teamed up with Northwestern University to provide audiology, speech, language and learning, and other vocal therapy services for transgender youth (Brotman, 2015). Providing gender-affirming healthcare to transgender individuals of all ages is a critical aspect of public health – CMS has an opportunity to act for the health and wellness of all Americans.

Respectfully yours,

Daniel Raedel, MA

References:

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Essentially you have concluded that a National Coverage Determination is deemed not possible due to a lack of sufficient data to support this need. So, it must be left to the MAC's, privately owned enterprises, to make such determinations as to whether or not gender reassignment surgery is necessary for a given person.

It is difficult enough for transgender people to receive medical care, as some medical personnel simply refuse to provide trans people with service. Now, laws are being passed that permit medical persons to decline providing service based on religious beliefs. It is this type of problem within the medical establishment that contributes to gender dysphoria within the trans community. [PHI Redacted]

It is a failure of the medical community to have not generated sufficient data with which to cause approval for an NCD. Consider that gender reassignment surgeries have been performed since at least the mid forties. I can only guess that because [transgender people] are such a minor part of the overall population that such studies were deemed unimportant for consideration.

An NCD would, as I see it, prevent any corporate biases regarding transgender people, a bias that does exist as evidenced by those medical facilities that refuse to service [transgender people]. This in all likelihood does not amount to sound reasoning for the NDC to you, but the facts are that discrimination and politics is a fact of life where it concerns transgender people and the service [they] may or may not receive. Considering that [they] must undergo certain psychiatric / psychological counselings, medical evaluations for hormone treatment, blood tests, etc., I would think that there are essentially enough hoops to jump through to attain the surgeries need[ed] without having to rely on the politics of private insurers.

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The decision to deny an NCD will negatively impact many transgender and transsexual members of the population. As you recognize in your own review of data, many members of the trans community experienced significantly better mental health when given access to gender affirming surgeries. Improved mental health has been shown to improve overall health.

Further, leaving the decision of whether or not to allow a person to access a therapy that would be of benefit, in the opinion of their therapist and in the opinion of the person in question, at the discretion of local administrators creates regional disparities in terms of healthcare access. Local and regional bias WILL negatively impact some Medicare recipients and as a result of personal bias, not sound medical judgment, these individuals will be denied access to procedures which would improve their quality of life.

Also, allowing individual contractors to make these decisions unilaterally means that decisions will likely be heavily influenced by cost rather than the merit of the procedure in question. This is an unethical manner by which to practice medicine.

Further, the mention that the number of trans seniors is quite small is also meaningless. Their small population size does not invalidate their existence or need for competent medical care.

Included in the proposal are some studies which seem predicated on the previous definitions of Gender Dysphoria from the DSM(IV) and earlier. These diagnoses are not accurate (as evidenced by the modification of diagnostic material for Gender Dysphoria in the DSM(V)). These studies then, are influenced by the belief that trans people are mentally ill as part of their condition which taints the study and biases the researchers and how they conduct their data collection and analysis. This is unacceptable.

So look, if you want to know about trans health and the outcomes check with the people who run the US Trans Health survey. Send someone to the Annual Philadelphia Trans Health Conference. They would be better equipped to assist in finding the information you need. There are also specialists in the field of trans health. Try talking to some of them about how they function within the trans community. Your proposal is dependent on transphobic material which, you admit is lacking in many areas. Instead of waiting for the information to come to you reach out. We would be more than happy to oblige in helping you write up a reasonable proposal.

(Oh and there are plenty of "late-closeted" trans people. As the social climate becomes more favorable for trans people more of our elders will come out and seek transition in one way or another. As Medicare will be dealing with the care of many of them it is imperative that the organization be ready to meet their needs fairly and adequately. This proposal does not do that.)

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[PHI Redacted]

I am also under the impression that the WPATH and the WHO standards for Transgender care are unfavorably biased against any Transgender/Transexual Person.

As to the lack of double blinds, it is evident that many people want to suppress or corrupt much of the data pertaining to Transgender People. This current flare of unrestrained bias if not outright hate against Transgender people in bathrooms; only demonstrates in clear certain clarity.

[PHI Redacted]

Which only brings to light that issue: as to if the Gender Confirming Surgeries are vital and necessary. Yes, they are.

The Mental Health perspective of it should ring out as a resounding yes as well, that it is vital.

Is Mental Health aftercare important, surely, but it is evident that the longer a person bears the pressure of Gender Dysphoria, with no outlet or end; invariably ends up with a person in a worse mental and physical condition. Not to mention all the substance abuse issues as these people look to seek relief from the mental pain and anguish of being stuck in the 'wrong' body.

[PHI Redacted] I also note, the growing numbers of children who are transgender, that commit suicide from a lack of supportive care as well. It is well noted and received that trans*children who are well supported in their transition, do not suffer or give the appearance of self destructive traits.

[PHI Redacted] the longer a transgender person is forced to wait for gender confirmation surgeries, (SRS/GRS/ETC...) the more therapy and care they will need in the duration of their lives.

(Need I add in the homelessness/prostitution/human trafficking risks as well?)

Thank you for reading and considering my comments.

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I cannot believe this. Transgenders know at a very young age that they are in the wrong body and it has nothing to do with penises or vaginas. They live their whole life knowing that they are in the wrong body. Who are you, the government, to decide if transgender surgery is appropriate for Gender Dysphoria? I have to see what gender dysphoria does to a person on a daily basis. It affects everything in their lives. [PHI Redacted] is physically sick in the mornings before work because of what he has to endure on a daily basis because of this debate. Have any of you fenales ever wear a binder to squish your breasts down while at work or out in public? [PHI Redacted] will not be well until I can save enough money to have the surgery, the biggest roadblock being surgeons and politics.[PHI Redacted] If an individual is deemed to be the opposite sex per their physician, then there should be no hurdles to name and gender changes in the legal system. Why is it so difficult to understand???? You are messing with peoples lives in the most inappropriate ways.

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Please note that in addition to Medicaid currently covering this, so to is the Veterans Administration taking action to do the same. Additionally, WHO in their ICD-11, an update to their document, is reclassifying their diagnostic category related to gender identity.

It is most difficult for many transgender people to afford GRS without insurance coverage. People [PHI Redacted] while either in part time or full time transition may only be able to transition up to the point of surgery. This does have a psychological impact and contributes to dysphoria, often significantly.

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