Medicare denies national coverage for gender reassignment surgery: No evidence of therapeutic outcome
August 31, 2016
On June 2, 2016 the Centers for Medicare & Medicaid Services (CMS) denied national coverage for gender reassignment surgery after the agency conducted a year long review which determined that there is no medical evidence of a therapeutic outcome for patients who have undergone these procedures.
Excerpts from their report:
On December 3, 2015, CMS accepted a formal complete request from a beneficiary to initiate a national coverage analysis (NCA) for gender reassignment surgery.
CMS opened this National Coverage Analysis (NCA) to thoroughly review the evidence to determine whether or not gender reassignment surgery may be covered nationally under the Medicare program.
In general, when making national coverage determinations, 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 for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. (§ 1862 (a)(1)(A)). The evidence may consist of external technology assessments, internal review of published and unpublished studies, recommendations from the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), evidence-based guidelines, professional society position statements, expert opinion, and public comments.
The overall objective for the critical appraisal of the evidence is to determine to what degree we are confident that: 1) specific clinical question relevant to the coverage request can be answered conclusively; and 2) the extent to which we are confident that the intervention will improve health outcomes for patients.
CMS staff extensively searched for primary studies evaluating therapeutic interventions for gender dysphoria. There was particular emphasis on the various surgical interventions, but other treatments including hormone therapy, psychotherapy, psychiatric treatment, ancillary reproductive and gender modifying services, and post-operative surveillance services for natal sex organs were also included because of their serial and sometimes overlapping roles in patient management. The emphasis focused less on specific surgical techniques and more on functional outcomes unless specific techniques altered those types of outcomes.
The reviewed evidence included articles obtained by searching literature databases and technology review databases from PubMed (1965 to current date), EMBASE, the Agency for Healthcare Research and Quality (AHRQ), the Blue Cross/Blue Shield Technology Evaluation Center, the Cochrane Collection, the Institute of Medicine, and the National Institute for Health and Care Excellence (NICE) as well as the source material for commentary, guidelines, and formal evidence-based documents published by professional societies. Systematic reviews were used to help locate some of the more obscure publications and abstracts.
CMS reviewed and considered potential objective measures of function including mortality, psychiatric treatment, and attempted suicide. None of the longitudinal studies in which patients served as their own control, however, comprehensively tracked changes in these events as objective measures of function before and after surgery. Events such as suicide and institutionalization were mentioned incidentally when describing patients excluded from a follow-up study or during the study (Heylens et al., 2014; Ruppin, Pfafflin, 2015). Other times investigators tracked these functional outcomes (e.g., psychiatric out-patient treatment, psychiatric in-patient treatment, and substance abuse) for the most current prior year (Ruppin, Pfafflin, 2015).
The most comprehensive study with functional endpoints, the Swedish study that followed all patients who had undergone reassignment surgery (at mean age 35.1 years) over a 30 year interval and compared them to 6480 matched controls, identified increased mortality and increased psychiatric hospitalization (Dhejne et al., 2011). The mortality was primarily due to completed suicides (19.1-fold greater than in control Swedes), but death due to neoplasm and cardiovascular disease was increased 2 to 2.5 times as well. The divergence in mortality from the Swedish population did not become apparent until after 10 years. The risk for psychiatric hospitalization was 2.8 times greater than in controls even after adjustment for prior psychiatric disease (18%). The risk for attempted suicide was greater in male-to-female patients regardless of the gender of the control. Unfortunately, the study was not constructed to assess the impact of gender reassignment per se. The finding of this study, again, demonstrated that reassignment surgery does not return patients to a normal level of morbidity risk and that the morbidity risk is significant, because of its clinical importance, its persistence over the interval of data collection and the increase in risk over time for the individual.
The currently available evidence has limitations:
- There were design deficiencies. All but one of the studies were observational in nature. All but two were non-blinded. The accompanying loss to follow-up suggests that there is selection bias and that the population that seeks treatment for gender dysphoria is not the same population that undergoes reassignment surgery without hesitation or regret.
- The psychometric and psychosocial function endpoints are not well validated.
- There were limitations of the psychosocial endpoints and of the data collection of other hard functional outcomes. Evidence on mortality and especially suicide was stronger. The mortality and psychiatric hospitalization rates even after vetting in highly structured programs are of concern.
- There are insufficient data to select optimal candidates for surgery.
- 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).
Data on reassignment surgery performed on geriatric patients or follow-up data in geriatric patients who had reassignment surgery in the distant past is anecdotal (Orel, 2014).
Based on a thorough review of the clinical evidence available at this time, there is not enough evidence to determine whether gender reassignment surgery improves health outcomes for Medicare beneficiaries with gender dysphoria. There were conflicting (inconsistent) study results – of the best designed studies, some reported benefits while others reported harms.
The quality and strength of evidence were low due to the mostly observational study designs with no comparison groups, potential confounding and small sample sizes. Many studies that reported positive outcomes were exploratory type studies (case-series and case-control) with no confirmatory follow-up. Due in part to the generally younger and healthier study participants, the generalizability of the studies to the Medicare population is also unclear. Additional research is needed. This proposed conclusion is consistent with the West Midlands Health Technology Assessment Collaboration (2009) that reported “[f]urther research is needed but must use more sophisticated designs with comparison groups.” WPATH also noted the need for further research: “More studies are needed that focus on the outcomes of current assessment and treatment approaches for gender dysphoria.” Further, as mentioned earlier, patient preference is an important aspect of any treatment. With that in mind, CMS is interested in knowing from the patients with gender dysphoria what is important to them as a result of a successful gender reassignment surgery.
Knowledge on gender reassignment surgery for individuals with gender dysphoria is evolving. The specific role for various surgical procedures is less well understood than the role of hormonal intervention. Much of the available research has been conducted in highly vetted patients at select care programs integrating psychotherapy, endocrinology, and various surgical disciplines and operating under European medical management and regulatory structures. Standard psychometric tools need to be developed and tested in the patients with gender dysphoria to validly assess long term outcomes. As such, further evidence in this area would contribute to the question of whether gender reassignment surgery improves health outcomes in adults with gender dysphoria.
Because CMS is mindful of the unique and complex needs of this patient population and because CMS seeks sound data to guide proper care of the Medicare subset of this patient population, CMS strongly encourages robust clinical studies with adequate patient protections that will fill the evidence gaps delineated in this decision memorandum.
Currently, the local Medicare Administrative Contractors (MACs) determine coverage of gender reassignment surgery on an individual claim basis. The Centers for Medicare & Medicaid Services (CMS) proposes to continue this practice and not issue a National Coverage Determination (NCD) at this time on gender reassignment surgery for Medicare beneficiaries with gender dysphoria. Our review of the clinical evidence for gender reassignment surgery was inconclusive for the Medicare population at large.
Read the complete evidence review and text of Medicare’s denial of a national coverage determination for ‘Gender Reasignment Surgery” here: