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Department Health and Human Services DEPARTMENTAL APPEALS BOARD Appellate Division NCD 140.3, Transsexual Surgery Docket No. A-13-87 Decision No. 2576 May 30, 2014 DECISION The Board has determined that the National Coverage Determination (NCD) denying Medicare coverage all transsexual surgery treatment for transsexualism not valid under the "reasonableness standard" the Board applies. The NCD was based information compiled 198 The record developed before the Board response complaint filed the aggrieved party (AP), Medicare beneficiary denied coverage, shows that even assuming the NCD's exclusion coverage the time the NCO was adopted was reasonable, that coverage exclusion longer reasonable. This record includes expert medical testimony and studies published the years after publication the NCD. The Centers for Medicare Medicaid Services (CMS), which responsible for issuing and revising NCDs, did not defend the NCD the NCD record this proceeding and did not challenge any the new evidence submitted the Board. Effect this decision Since the NCD longer valid, its provisions are longer valid basis for denying claims for Medicare coverage transsexual surgery, and local coverage determinations (LCDs) used adjudicate such claims may not rely the provisions the NCD. The decision does not bar CMS its contractors from denying individual claims for payment for transsexual surgery for other reasons permitted law. Nor does the decision address treatments for transsexualism other than transsexual surgery. The decision does not require CMS revise the NCD issue new NCD, although CMS, course, may choose so. CMS may not reinstate the invalidated NCD unless has different basis than that evaluated the Board. C.F.R. 426.563. CMS must implement this Board decision within days and apply any resulting policy changes claims service requests made Medicare beneficiaries other than the for any dates service after that implementation. With respect the AP's claim particular, CMS and its contractors must "adjudicate the claim without using the provision(s) the NCD that the Board found invalid." C.F.R. 426.560(b)( ).1 With exceptions not relevant here, section 862(a)(l)(A) the Social Security Act (Act) U.S.C. 395y(a)(l)(A)) bars Medicare payment for items services "not reasonable and necessary for the diagnosis treatment illness injury[.]"CMS refers this requirement the "medical necessity provision." Fed. Reg. 54,534, 54,536 (Aug. 22, 2002). NCD determination the Secretary [of Health and Human Services] with respect whether not particular item service covered nationally under [title XVIII (Medicare)]." Act 862(1)(6)(A), 869(f)(l)(B); see also C.F.R. 400.202 (NCO "means decision that CMS makes regarding whether cover particular service nationally under title XVIII the Act."). NCDs "describe the clinical circumstances and settings under which particular [Medicare items and] services are reasonable and necessary (or are not reasonable and necessary)." Fed. Reg. 54,535. When CMS issues NCDs, they apply nationally and are binding all levels administrative review Medicare claims. C.F.R. 405.1060. CMS and its contractors use applicable NCDs determining whether beneficiary may receive Medicare reimbursement for particular item service. C.F.R. 405.920, 405.921. Medicare beneficiary "in need coverage for service that denied based ... NCD" "aggrieved party" who may challenge the NCD filing "complaint" with the Board.Act 869(f)(l); C.F.R. 426.110, 426.320. The complaint must comply with the requirements for valid complaint C.F.R. 426.500 order accepted the Board. C.F.R. 426.51 O(b )(2), 426.505(c)(2). After the Board notifies CMS the receipt complaint that acceptable under the regulations, CMS produces the "NCD record," which "consists any document material that CMS See generally C.F.R. 426.560(b) (setting out the effects Board NCO decision); C.F.R. 426.555 (specifying what the Board's decision "may not do"). This decision has effects beyond those set out C.F.R. 426.560(b) and does not impose CMS its contractors any orders requirements prohibited C.F.R. 426.555. The table contents the cunent version the Social Security Act, with references the conesponding United States Code chapter and sections, can found Home/ssact/ssact-toc.htm. The regulations also provide that person other than the aggrieved party with interest the issues may petition participate the review process amicus curiae. C.F.R. 426.5 IO(t), 426.513. The Board posts its website notice the NCD complaint specifying time period for requests participate the review. C.F.R. 426.5 IO(t). considered during the development the NCD" including "medical evidence considered before the date the NCD was issued .... C.F.R. 426.510(d)(3), 426.51 426.5 8(a). The aggrieved party submits statement "explaining why the NCD record not complete, not adequate support the validity the NCD under the reasonableness standard," and CMS may submit response "in order defend the C.F.R. 426.525(a), the Board determines that the NCD record "is complete and adequate support the validity the NCD," the review process ends with the Board's "[i]ssuance decision finding the record complete and adequate support the validity the NCD .... C.F.R. 426.525(c)( l), (2). the Board determines that the record not complete and adequate support the validity the NCD, the Board "permits discovery and the taking evidence ... and evaluates the NCD" evidence" defined "clinical scientific evidence that was not previously considered ... CMS before the ... NCD was issued." C.F.R. 426.110. IftheBoard concludes, the Board stays proceedings for CMS "to examine the new evidence, and decide whether [to] initiate ... reconsideration" the NCD. C.F.R. 426.340(d). CMS does not reconsider the NCD, reconsiders but does not change the challenged provision, the Board lifts the stay and the NCD challenge process continues. C.F.R. 426.340(f). the end that process, the Board closes the record and issues decision that the challen,red "provision the NCD valid" "is not valid under the reasonableness standard." C.F.R. 426.5 50. The Board's decision "constitutes final agency action and subject judicial review" appeal aggrieved party. C.F.R. 426.5 66. Section 426.547(b) states that the Board must make the decision available the HHS Medicare lnternet site and that "the posted decision does not include any infonnation that identifies any individual, provider service, supplier." CMS has indicated the preamble the Part 426 regulations that this provision was meant protect the privacy Medicare beneficiaries such the AP. e.g., Fed. Reg. 63,692, 63,708 (Nov. 2003) ("Board decisions regarding NCDs will made available the Medicare Jnternet site, without beneficiary identifying information"). Case The NCD and the NCD record 5The challenged NCD, titled "140.3, Transsexual Surgery," states: Item/Service Description Transsexual surgery, also known sex reassignment surgery intersex surgery, the culmination series procedures designed change the anatomy transsexuals conform their gender identity. Transsexuals are persons with overwhelming desire change anatomic sex because their fixed conviction that they are members the opposite sex. For the male-to-female, transsexual surgery entails castration, penectomy and vulva-vaginal construction. Surgery for the female-to-male transsexual consists bilateral mammectomy, hysterectomy and salpingo oophorectomy, which may followed phalloplasty and the insertion testicular prostheses. Indications and Limitations Coverage Transsexual surgery for sex reassignment transsexuals controversial. Because the lack well controlled, long-term studies the safety and effectiveness the surgical procedures and attendant therapies for transsexualism, the treatment considered experimental. Moreover, there high rate serious complications for these surgical procedures. For these reasons, transsexual surgery not covered. NCD Record 93. CMS's predecessor, the Health Care Financing Administration (HCFA), published the NCD the Federal Register August 21, 1989.54 Fed. Reg. 34,555, 34,572 (Aug. 21, 1989); NCD Record 76, 78, 93, 128. The NCD quotes paraphrases portions 11-page report that the former National Center for Health Care Technology (NCHCT) the HHS Public Health Service (PHS) issued 1981, titled NCDs are available The Federal Register notice stated, "This notice lists those current Medicare national coverage decisions which have been issued the Medicare Coverage Issues Manual (HCFA Pub. 6)." Fed. Reg. 34,555. "Evaluation Transsexual Surgery" (1981 report).NCD Record 13-23. The NCH forwarded the 1981 report HCF with May 1981 memorandum stating that the 1981 report "concludes that transsexual surgery should considered experimental because the lack proven safety and efficacy the procedures for the treatment transsexualism" and recommending "that transsexual surgery not covered Medicare this time." Id. 12. The NCD record includes three April 1982 letters from the American Civil Liberties Union (ACLU) Southern California disagreeing with HCFA's noncoverage determination. Id. 24-25, 26, 41-42. The ACLU submitted letters and affidavits from physicians and therapists supporting the medical necessity transsexual surgery and taking issue with the non-coverage determination. Id. 27-75. May 11, 1982, the HCFA physicians panel, vote five two, recommended against referring the ACLU's submissions PHS, "on the basis that does not contain information about new clinical studies other medical and scientific evidence sufficiently substantive justify reopening the previous PHS assessment." Id. Thus, although the NCD was issued 1989, was based the analysis medical and scientific publications the 1981 report. The NCD complaint The this case, Medicare beneficiary whose insurer denied physician's order for sex reassignment surgery (transsexual surgery), filed acceptable NCD complaint and supporting materials. CMS submitted the NCD record May 15, 2013, and the submitted statement why the NCD record not complete adequate support the validity the NCD under the reasonableness standard (AP Statement) June 14, 2013. The Board granted unopposed requests six advocacy organizations participate amici curiae the NCD review filing written briefs arguing that the NCD was invalid. (Four the amici submitted joint brief.) The concluding summary the 1981 NCHTC report stated relevant part: Transsexual surgery for sex reassignment transsexuals controversial. There lack well controlled, long-term studies the safety and effectiveness the surgical procedures and attendant therapies for transsexualism. There evidence high rate serious complications these surgical procedures. The safety and effectiveness transsexual surgery treatment transsexualism not proven and questioned. Therefore, transsexual surgery must considered still experimental. NCD Record 19. The six amici are the Human Rights Campaign (HRC) and the World Professional Association for Transgender Health (WP TH), which each submitted briefs, and the FORGE Transgender Aging Network, the National Center for Transgender Equality, the Sylvia Rivera Law Project, and the Transgender Law Center, which submitted joint brief. June 26, 2013, CivIS notified the Board that "declines submit response" the AP's statement. December 2013, the Board ruled that the NCO record "is not complete and adequate support the validity the NCD[.]'' NCD 140. Transsexual Surgery, NCD Ruling No. (Dec. 2013) ('JCD Ruling). 'T'he parties then jointly reported that they did not intend submit additional evidence (except for curricula vitae (CV the AP' witnesses) cross-examine any witness and asked the Board close the NCD review record the taking evidence and decide the case based the written record. The Board determined that the new evidence the record had the potential significantly affect its review the NCO and, required, stayed proceedings for days for CivIS examine the new evidence and decide whether reconsider the NCD. Order Closing Record Staying Proceedings for CMS Determine Whether Reconsider NCD (Feb. 25, 2014) (Order); C.F.R. 426.340(d), 426.505(d)(3). T'.vo days later, CMS informed the Board email that "does not wish reconsider the NCD." February 28, 2014, the Board lifted the stay and informed the parties that would proceed decision. The record developed before the Board The record before the Board consists the NCD record, the briefs submitted the and the amici and evidence submitted the and one the amici, the Human Rights Campaign. Since neither party submitted argument evidence (except for the CVs) after the Board's Ruling, the Board treats the statement the AP's brief this appeal. The submitted written declarations made under penalty perjury from clinical psychologist and physician, and two notarized physician letters submitted Administrative Law Judge the Department Health and Human Services Office Medicare Hearings and Appeals another matter. The described the witnesses, who are active the field treating trans gender persons, experts and submitted their resumes CVs. Statement complaint; AP/CMS e-mail (Jan. 2014). The NCD Ruling The Board also published its website notice providing additional time period for interested parties submit participation requests; none were received. Most the P's evidence other than witness statements appendix sources the clinical psychologist cited her declaration. refer these materials the P's exhibits (AP Exs.) and cite the page numbers used the publications which they appeared. addition, the physician's declaration includes appendix of20 unnumbered pages insurance regulations from four states and the District Columbia barring exclusion sex reassignment surgery medically necessary treatment for severe gender dysphoria. One the amici, the Human Rights Campaign, submitted exhibits with its brief ("HRC Exs.''). CMS did not challenge the witnesses' qualifications experts seek cross-examine them. summarize their qualifications when address their testimony below. this decision use the term "new evidence" refer the evidence submitted the C.F.R. 426.110, "new evidence" would also include any evidence submitted CMS response NCD complaint that was not considered CMS before the NCD was issued. this case, however, discuss below, CMS submitted "new evidence." Standard review The Board "evaluate[s] the reasonableness" NCD determining whether "is valid [or] not valid under the reasonableness standard," which requires uphold the NCD "if the findings fact, interpretations oflaw, and applications fact law ... CMS are reasonable" based the NCD record and the relevant record developed before us. Act 869(t)(l)(A)(iii); C.F.R. 426.110, 426.53 l(a), 426.550(a). The Board "defer[s] only the reasonable findings fact, reasonable interpretations law, and reasonable applications fact law the Secretary." Act 1869(t)(l)(A)(iii); C.F.R. 426.505(b). During the review, the aggrieved party bears the burden proof and the burden persuasion for the issues raised NCD complaint; the burden persuasion judged preponderance the evidence. C.F.R. 426.330. CMS has explained that "[s]o long the outcome [in the NCO] one that could reached rational person, based the evidence the record whole (including logical inferences drawn from that evidence), the determination must upheld," and that CMS "has logical reason why some evidence given more weight than other evidence," the Board "may not overturn the determination simply because they would have accorded more weight the evidence support coverage." Fed. Reg. 63,703. The NCD invalid because preponderance the evidence the record whole supports conclusion that the NCD's stated bases for its blanket denial coverage for transsexual surgery are not reasonable. previously stated, the NCD was based principally the 1981 report findings that the safety and effectiveness transsexual surgery had not been proven. The argues that these findings are not "supportable the current state medical science" and "not reasonable light the current state scienti fie and clinical evidence and current medical standards care and are contradicted studies conducted the years since the 1981 report. Statement 6-7, 14. The amici made similar arguments. See, e.g., WPATH Br. ("since [the NCD] was issued, has been repeatedly demonstrated that SRS [sex reassignment surgery] safe, effective, and indisputably necessary treatment for eertain individuals with severe GID [gender identity disorder]"). discuss below, the new evidence, which unchallenged, indicates that the bases stated the NCD and the NCD record for denying coverage, even assuming they were reasonable when the NCD was issued, are longer reasonable. The fact that the new evidence unchallenged and the NCD record undefended significant. stated earlier, the has the burden proof preponderance the evidence that NCD invalid under reasonableness standard. deciding whether the has met this burden, must weigh the evidence the record before us. Thus, consider important note the outset that the only evidence before us, other than the record for the NCD, which consists principally the 1981 report, the new evidence submitted the and the amicus HRC. CMS submitted the NCD record, was required do, but has not argued that that record any other evidence supports the NCD. CMS also did not elect cross-examine the AP's witnesses, has not challenged their testimony professional qualifications and joined the asking the Board decide the appeal based the written record. See AP/CMS e-mail (Jan. 2014). The preamble the regulations that implement the NCD statute states that the "reasonableness standard ... recognizes the ... CMS the Medicare the area the exercise clinical scientific Fed. Reg. 63,703 (emphasis added). Accordingly, determining whether the NCD valid under the reasonableness standard, must accord some deference CMS's position, and its decision not defend the NCD challenge the new evidence this case has some Apart from the absence any challenge the new evidence defense the NCD record, find the new evidence credible and persuasive its face.We have difiiculty concluding that the new evidence, which includes medical studies published the more than years since issuance the 1981 report underlying the NCD, outweighs the NCD record and demonstrates that transsexual surgery safe and effective and not experimental. Thus, discuss below, the grounds for the NCD's exclusion coverage are not reasonable, and the NCD invalid. For this reason, found unnecessary exercise our independent authority "consult with appropriate scientific clinical experts concerning clinical and scientific evidence." See C.F.R. 426.531 The new evidence indicates acceptance criteria for diagnosing transsexualism. Transsexual surgery treatment option for the medical condition transsexualism. The NCD recognized that transsexualism diagnosed medical condition. The report stated that transsexualism "is defined overwhelming desire change anatomic sex stemming from the fixed conviction that one member the opposite sex." NCD Record 13, citing Dorland's Tllustrated Medical Dictionary, 25th ed. The report recognized that the American Psychiatric Association's Diagnostic and Statistical Manual Mental Disorders issued (DSM III) had "included for the first time the diagnostic category 'Transsexualism."' NCD Record 13. Nonetheless, the 1981 report expressed concern that diagnosing transsexualism was "problematic" because, the report contended, the criteria for establishing the diagnosis "vary from center center and have changed over time." NCD Record 14. One the AP's expert witnesses, Randi Ettner, Ph.D., clinical psychologist, testified that the expressed basis for this concern "completely untrue now." Ettner Supp. Deel. Dr. Ettner stated that "Gender Identity Disorder serious medical condition codified the International Classification Diseases oth revision; World Health Organization) and the [DSM]."Ettner Deel. 10; see also Ettner Supp. Deel. (similar testimony). She described the condition follows: The disorder characterized intense and persistent discomfort with one's primary and secondary sex characteristics-one's birth sex. The suffering that arises often described "being trapped the wrong body." The psychiatric term for this severe and unremitting emotional pain "gender dysphoria." Ettner Deel. 10. Dr. Ettner' declaration and state that she has doctorate psychology, has evaluated treated between 2,500 and 3,000 individuals with GID and mental health issues related gender variance, has published three books, including Principles Transgender Medicine and Surgery, has authored articles peer-reviewed journals, and member the board directors the World Professional Association for Trans gender Health (WP ATH) and author the Standards Care for The record indicates that the term "transsexualism" that was used the NCD and the DSM-lll was succeeded the DSM-IV and DSM-V the terms "Gender Identity Disorder" (GID) and "gender dysphoria." Statement Ettner Supp. Deel. aq[ Hsiao Deel. aq] 11; Ex. 208; WPATH Br. n.3. this decision, use the term "transsexualism" because used the NCD, but our decision should read encompassing the successor terminology well. the Health Transsexual, Trans gender, and Gender-Nonconforming People. Id. irir 36; see also Sundstrom Frank, 630 Supp. 974, 986-87 (E.D.Wis. 2007) ("Dr. Ettner' experience speaks for itself ... the doctor has conducted research and has been instructor specializing the etiology, diagnosis and treatment GID [and] the editor find nothing the new evidence that would undercut Dr. Ettner's statement. The DSM-IV-TR (text revision), published 2000, continues recognize "transsexualism" diagnosed medical condition, although refers the same disorder GID and identifies criteria for diagnosing GID adolescents and adults that are consistent with Dr. Ettner's description, albeit more detailed. The criteria include "strong and persistent cross-gender identification (not merely desire for any perceived cultural advantages being the other sex)" that "manifested symptoms such stated desire the other sex, frequent passing the other sex, desire live treated the other sex, the conviction that she has the typical feelings and reactions the other sex;" "[p ]ersistent discomfort with his her sex sense inappropriateness the gender role that sex" that "manifested symptoms such preoccupation with getting rid primary and secondary sex characteristics (e.g., request for hormones, surgery, other procedures physically alter sexual characteristics simulate the other sex) belief that she was born the wrong sex;" and ''[t]he disturbance not concurrent with physical intersex condition." Ex. 581. The DSM-IV-TR states that ifGID present adults, "[t]he disturbance can pervasive that the mental lives some individuals revolve only around those activities that lessen gender distress." Id. 576, 78. The WPATH brief indicates that transsexualism GID remains diagnostic category the fifth edition the DSM issued 2013 (DSM-V), which uses the term "Gender Dysphoria." WPATH Br. n.3. The DS1/I has been recognized primary diagnostic tool American psychiatry. See 'Donnabhain Comm Internal Revenue, 134 T.C. 34, (2010) (stating "all three experts agree [that the DSM-IV-TR] the primary diagnostic tool American psychiatry"); see also Ex. 114 (resolution American Medical Association tiouse Delegates noting the DSM description GID persistent discomfort with one's assigned sex and with one's primary and secondary sex characteristics, which causes intense emotional pain and suffering" that "if left untreated, can result clinically significant psychological distress, dysfunction, debilitating depression and, for some people without access appropriate medical care and treatment, suicidality and death"). American Medical Association House Delegates, Resolution 122 (A-08), Removing Financial Barriers Care for Transgender Patients (2008). conclude that the extent the NCD was based concerns expressed the NCD record about problems diagnosing transsexualism, that concern unreasonable based the new evidence. The new evidence indicates that transsexual surgery safe. The 1981 report stated that transsexual surgery "cannot considered safe because the high complication rates." NCD Record 18. The 1981 report identified surgical complications including "rectovaginal fistulas, perinea[ abscesses, introital and deep vaginal stenosis, and vaginal shortening" male-to-female (MF) patients, and "rejection the testicular implants, scrotal fusion, and phalloplasty infections" female-to-male (FM) patients, and states that "[m]ultiple complications for individual patients and secondary surgeries correct complications improve undesirable results are not uncommon." Id. (citations omitted). The argues that "advancements surgical techniques have dramatically reduced the risk complications from sex reassignment surgery and the rates serious complications from such surgeries are low" and that the studies cited the 1981 report "evaluated outdated surgical techniques that have been replaced with improved, safer procedures." Statement 10. The new evidence supports the AP. Expert witness Katherine Hsiao, M.D., testified that hysterectomies and mastectomies are common procedures used treat gender GID transgender men (FM) and "are routinely performed other contexts, such cases breast cancer, ovarian cancer, uterine cancer and/or cervical cancer .... Hsiao Deel. 11. These procedures, she stated, "have low rates complications" and are "generally identical whether performed transgender men treat gender dysphoria treat women for these other conditions."Id. Dr. Hsiao also stated that "insurance companies routinely cover the costs associated" with hysterectomies. Id. Dr. Hsiao testified that based her own practice providing surgery trans gender men, "gender affirming surgeries for transgender men are extremely safe and have very low rates serious complications," are unable discuss the space this decision all the new evidence and see need since all unchallenged. However, find nothing the new evidence not discussed that would alter our conclusion that the NCD invalid, least absent argument counter-evidence from CMS. have attached this decision Overview the Scientific Literature the New Evidence. Dr. Hsiao testified without contradiction that "serious complication" surgery- generally understood among surgeons include death, conditions requiring unplanned admission the Intensive Care Unit unplanned readmission the hospital within days, severe hemorrhage requiring transfusion several units blood product, permanent disability, intraoperative injury requiring unplanned intervention during the surgical procedure, pennanent brain damage, cardiac atTest. Hsiao Deel. that she has performed hysterectomies for transgender men for the past ten years and that those procedures "are generally identical the ones perform women treat early cancer other conditions." Id. 20. Dr. Hsiao reports having "typically performed multiple obstetrical, gynecologic, other pelvic surgeries every week, including but not limited hysterectomies and other advanced pelvic surgeries targeting the reproductive system and adjacent organs .... Id. Dr. Hsiao's declaration and indicate that she certified the American Board Obstetrics and Gynecology, the chief the division gynecology and the director Ob/Gyn resident education California medical center and assistant clinical professor the department obstetrics, gynecology and reproductive medicine the University California San Francisco. Id. irir 3-6; CV. Dr. Hsiao further stated, regarding transsexual surgery, that she has been part surgical team that performed surgery create neovagina women born with congenital "complete partial absence vagina, cervix, and uterus,'' condition called Mayer-Rokitansky-Kuster-Hauser syndrome, MRKH. Hsiao Deel. 12. She stated that this procedure has low rate complications, and that the associated surgical costs are, her experience, "routinely cover[ ed] insurance companies for women born with MRKH. She stated that while women with MRKH "can never have biological children ... the role surgery essential affirm their gender identity and align their anatomy with that identity." Id. Dr.Ettner stated that "[t]here scientific medical basis for the D's statement that sex reassignment surgery has not been proven safe and has high rate serious complications; that the "[r]ates complications during and after sex reassignment surgery are relatively low, and most complications are minor;" and that the risk complications "has, moreover, been dramatically reduced since 1985." Ettner Deel. ifl 32, 34. Dr. Ettner testified that during eight years the Chicago Gender Clinic she "regularly consulted with our surgeon and "aware only two major surgical complications, both which were immediately repaired." Id. 36. She stated that the clinic "as whole has percent complication rate for genital surgery and that "the vast majority those complications [were] minor, all were easily corrected, and none involved surgical site infection readmission." Id. Dr. Ettner stated the 1981 report's discussion surgical complication rates was "outdated and irrelevant based current medical practices and procedures." Ettner Supp. Deel. particular, she stated that one the studies cited the 1981 report's discussion complications (Laub Fisk 1974) reflected the use surgical technique that "led unacceptably high rates fistulae and other complications and was later abandoned the study's authors. Id. 10. Another the AP's expert witnesses, Marci Bowers, M.D., stated her notarized letter that her experience performing gender-related surgeries, transsexual surgery "does not have higher rate complication than any other surgery, and fact has very few complications, which are mainly minor nature." Bowers Letter (Mar. Att. Statement. Dr. Bowers stated that she performs approximately 220 gender-related surgeries annually and has performed over 1000 "Male Female Gender Corrective Surgeries." Id. Her indicates that she has served the Chair the The fourth expert witness, Sherman Leis, M.D., stated that personally "perform[s] several gender reassignment procedures each week" and has "seen only relatively minor complications which are easily treated" and has "thus far seen life threatening complications from any the trans gender surgeries" has performed. Leis Letter (Feb. 28, 2013), Att. Statement. Dr. Leis's letter and indicate that Boardcertified plastic and reconstructive surgery and general surgery. Id. The testimony Drs. Ettner and Hsiao based studies well personal experience. Dr. Hsiao testified that she reviewed five studies the exhibits "that include complication rate data and information for gender affirming surgeries performed recent years" and that "[n]one these five studies reported high rates serious complications." Hsiao Deel. 13-14, citing studies Exs. 14, 21, 28. She stated that "almost all the complications listed these studies, such urinary incontinence retention, stenosis stricture, bleeding, recto-vaginal fistula, and partial necrosis, are not specific sex reassignment surgeries, but rather are known potential side effects any type urogenital surgery which are covered Medicare." Id. 'if 15. She further testified that "every complication tracked [Jarolim, al. (2009)] for instance, falls into this category and none them are serious;" that "[t]he Spehr (2007) what would potential, expected outcomes for any urogenital surgery." Id. 15-17, 1718 citing studies Exs. 14, 21,28.She also stated that the four "potentially serious" complications noted the Amend (2013) study patients, none "were serious that term generally understood." Id. 14, citing study Ex. Ladislav Jarolim, al., Gender Reassignment Surgery Male-to-Female Transsexualism: Retrospective 3-Month Follow-up Study with Anatomical Remarks, Sex. Med. 35-44 (2009). Anne Lawrence, Patient-Reported Complications and Functional Outcomes Male-to-Female Sex Reassignment Surgery, Arch. Sex. Behav. 717-27 (2006). Christiane Spehr, Male-to-Female Sex Reassignment Surgery Transsexuals, Int'! Transgenderism 25-37 (2007). Bastian Amend, al., Surgical Reconstruction.for Male-to-Female Sex Reassignment, Eur. Ural. 1-9 (2013). Dr. Hsiao further stated that Eldh al. 1997) compared complication rates for surgeries performed before and after 1986 and showed that "fn]early all the surgical complication rates decreased significantly over time." Hsiao Deel. 18, citing study Ex. 9.urogenital surgeries, decreased from percent surgeries before 1986 only percent between 1986 and 1995," and that "the only fistula that occurred after 1985 'closed spontaneously,' meaning without the need for any medical intervention." Id. Eldh, Dr. Hsiao stated, showed that "[t]here not high rate serious complications any the surgeries performed after 1986'' and she noted that "there have been nearly years additional surgical progress since the last surgery tracked." Id. Dr. Ettner cited the same five studies showing that surgical outcomes were "far superior'' after 1985 due "improvements technique, shortened hospital stays and improvements postoperative care;'' that significant surgical complications were uncommon; that only low percentage patients experienced complications, which were successfully resolved; and that "the complication rate low and most complications can overcome adequate correctional interventions." find reason discount the opinions these experts their representations regarding the findings the studies they cite. have conducted our own review the studies cited Dr. Hsiao and Dr. Ettner and find them consistent with these opinions and representations. note, for example, that Eldh, which divided the study group into those operated before 1986 and those operated from 1986-1995, made findings tending support these expert opinions. The Eldh study states: After 1985 the outcome surgery became much better not only because changes management but also because improvements surgical technique, preoperative planning, and postoperative treatment. Total time spent hospital decreased dramatically after 1985 because the number procedures was less and the rate early and late postoperative complications dropped. Haemorrhage and haematoma were common both groups, predominantly originating from the spongious tissue the common before then. The reason for the lower fistula rate the later group may ascribed better anatomical knowledge this region and more precise surgical technique. There was only one rectovaginal fistula after 1985 and this fistula closed spontaneously. Jan Eldh, al., Long-Term Follow After Sex Reassignment Surgery, Scand. Plast. Reconstr. Surg. Hand Surg. 39-45 1997). dramatically with the advent more sophisticated surgical techniques, among other reasons"). conclude that the has shown that the NCD's statement that transsexual surgery unsafe and has high rate complications not reasonable light the evolution surgical techniques and the studies outcomes discussed the unchallenged new evidence presented here. The new evidence indicates that transsexual surgery effective treatment option approprtate cases. The expert testimony and studies which the experts rely support the surgery's effectiveness. The argues that studies conducted after the 1981 report was issued confirm that transsexual surgery effective treatment for persons with severe gender dysphoria, and the expert testimony and studies support that argument. Statement 7-8. Dr. Ettner testified that "[b ]ased decades extensive scientific and clinical research, the medical community has reached the consensus that altering transsexual individual's primary and secondary sex characteristics safe and effective treatment for persons with severe Gender Identity Disorder." With regard effectiveness particular, Dr. Ettner testified that "more than three decades research confirms that sex reassignment surgery therapeutic and therefore effective treatment for Gender Identity Disorder" and that "for many patients with severe Gender Identity use the term "appropriate cases" because not read the new evidence necessarily stating that transsexual surgery appropriate all cases transsexualism, and our conclusion that the NCD's blanket preclusion Medicare coverage for transsexual surgery invalid does not require finding that effect. However, worth noting that has developed, its standards care, criteria for the use different transsexual surgical procedures. See, e.g., ]riteria for hysterectomy and salpingooophorectomy [FM] patients and for orchiectomy [MF] patients." Ex. 202 (E. Coleman, al., Standards Care for the Health Transsexual, Transgender, and Gender-Nonconforming People, Version lnt'l Transgenderism 165-232 (2011)). Dr. Ettner her declaration focuses genital surgery for the male-to-female (MF) transsexual. See Ettner Deel. 'if Dr. Hsiao's testimony addressed procedures performed patients. Hsiao Deel. 11, 20-21. Disorder, sex reassignment surgery the only effective treatment." Id. 19. She concluded that "[t]he NCD' determination regarding efficacy not reasonably supported scientific clinical evidence, standards professional practice, and fails take into account the robust body research establishing that surgery relieves, Id. 31. Dr. Bowers stated that "[m]any patients report dramatic improvement mental health following surgery, and patients have been able become productive members society, longer disabled with severe depression and gender dysphoria." Bowers Letter She concluded that "Gender Corrective Surgery has been shown life-saving procedure, and unequivocally medically necessary." Id. Dr. Leis stated that m]edical literature reports dramatic drop the incidence depression and suicide attempt[s] individuals who have undergone gender reassignment, indicating that many lives have been saved because this surgery," that "there very low incidence 'regret"' "only about patients who have had gender reassignment surgery" and that personally have never had single patient who has regretted having this surgery.'' Leis Letter Dr. Ettner cited studies published between 1987 and 2010 showing the effectiveness transsexual surgery. Ettner Deel. i;i; 20-2 28-30. She emphasized three studies, two which were published 1998 and 2007 and analyze other studies the treatment transsexuals published during the years 1961to 1991and1990 2007, respectively. Id. ;i; 20-22, citing studies 10, 25, 27; see also WPATH Br. 7-8 (discussing the same three studies). The 1998 study (Pfafflin Junge) reviewed "30 years international follow-up studies approximately two thousand persons who had undergone sex reassignment surgery" including more than individual studies and eight published reviews from four continents. Ex. unnumbered page 1.As "general results," the researchers the 1998 study stated that the studies they reviewed concluded "that gender reassigning treatments are effective," that positive, desired results outweigh the negative non-desired effects, and that "[p ]robably the most important change that found most research the increase subjective satisfaction [which] contrasts markedly the subjectively unsatisfactory start position the patients." The study's summary, which qualified "simplification," stated that the studies reviewed show that "[i]n over qualitatively different case studies and reviews from countries, has been demonstrated during the last years that the treatment that includes the whole process gender reassignment effective." Id. 66. The summary stated that all "follow-up studies mostly found the desired effects" the most important Friedemann Pfafflin Astrid Junge, Sex Reassignment: Thirty Years International Follow-Up Studies accessed May 29, 2014). stated that all "follow-up studies mostly found the desired effects" the most important which the patients felt were "the lessening suffering" and "desired changes the areas partnership and sexual experience, mental stability and socio-economic functioning level." Id. 66-67. The 2007 study, Gijs Brewaeys, which examined the results studies published that "[s]uicidality was significantly reduced postoperatively" and that patients there were suicide attempts after surgery opposed three attempts before surgery. Ex. 10, 188, 192. Dr. Ettner and ATH also cited what Dr. Ettner described large-scale prospective study" finding "that after surgery there was virtual absence gender dysphoria' the cohort and that the 'results substantiate previous conclusions that sex reassignment effective.'" Ettner Deel. 21, citing Smith al. (2005), Ex. 27;WPATH Br. Dr. Ettncr concluded that Smith al. and other studies have, variously, "shown that alleviating the suffering and dysfunction caused severe gender dysphoria, sex reassignment surgery improves virtually every facet patient's life," including "satisfaction with interpersonal relationships and improved social functioning,'' "improvement self-image and satisfaction with body and physical appearance," and "greater acceptance and integration into the family[.]" Ettner Deel. 24, citing studies She also cited nine studies having "shown that surgery improves patients' abilities initiate and maintain intimate relationships." Id. Based our own review the cited studies, find reason question the expert general, the studies included interviewing post-operative patients with variety surveys questionnaires assess changes different aspects their lives and psychological symptoms following surgery. The studies also generally used statistical techniques assess the results. The studies were conducted countries including the United States, Canada, Sweden, the Czech Republic, Israel, Brazil, The Netherlands, and Belgium. Luk Gijs Anne Brewaeys, Surgical Treatment Gender Dysphoria Adults and Adolescents: Recent Developments, Effectiveness, and Challenges, Ann. Rev. Sex Res. 178-224 (2007). Yolanda LS. Smith al., Sex Reassignment: Outcomes and Predictors a/Treatment/or Adolescent and Adult Transsexuals, Psycho!. Med. 89-99 (2005). note that these studies are scientific writings and not make sweeping pronouncements claim discoveries beyond possible doubt. Indeed, the authors sometimes qualify the results and caution against dr:nving overly broad and simplistic conclusions. See, (Pfafilin Junge, qualifying the study's summary its conclusion simplification). This, our view, enhances their facial credibility. Nonetheless, even keeping mind the possible limitations these studies, they support the AP's position that transsexual surgery has gained broad acceptance the medical community. The 1981 report's expressed concern about alleged lack controlled, long-term studies not reasonable light the new evidence. The 1981 report summarized the findings nine studies "[t]he result outcome of' transsexual surgery. NCD record 18. With respect those studies, the report stated that "surgical complications are frequent, and very small number post-surgical suicides and psychotic breakdowns are reported." Id. 17-18. However, the report also acknowledged that eight those nine studies "report that most transsexuals show improved adjustment variety criteria after sex reassignment surgery, and that "[i]n all these studies the large majority those who received surgery report that they are personally satisfied with the change[.]" Record 17. Notwithstanding its discussion these studies, the 1981 report (and the NCD) cited alleged "lack well controlled, long term studies the safety and effectiveness the surgical procedures and attendant therapies for transsexualism" ground for finding the procedures "experimental." Id. 19. The 1981 report did not define "long term" for the purpose assigning weight study results and the NCD record provided clarification that phrase. The 1981 report noted "post-operative followup" and "followup" times for eight the nine studies the outcomes surgery, with "average," "mean" "median" periods ranging from months over eight years, and individual periods from three months years. NCD Record 15-17. these studies not qualify acceptable record. Even assuming the studies cited the 1981 report could viewed not sufficiently "long-term," Dr. Ettner stated that "there are numerous long-term follow-up studies surgical treatment demonstrating that surgeries are effective and have low complication rates" and, discussed above, her testimony cited some those studies. Ettner Deel. i126. CMS does not challenge this statement, and find reason question it. note that the participants one study Dr. Ettner cited had mean interval since vaginoplasty of75.46 months. Ex. 30, 754.Ve also note that the studies published between 1990 and 2006 and encompassing 807 NIF and patients analyzed Gijs Brewaeys (2007) had mean follow-up durations ranging from six months long (in one study) 168 months. Ex. 10, 186-87.Additionally, two studies Dr. Ettner cited appear long term that they studied patients who had undergone surgery during periods and years, respectively. Exs. 13,29.Those studies reported favorable overall results. Dr. Ettncr also testified that two studies from 1987 and 1990 used control groups and found improved psychosocial outcomes surgery patients. Ettner Deel. ,!if 28-30. the 1990 study, she stated, patients were "'matched for family and psychiatric histories and severity the GID] diagnosis" and "randomly assigned either immediately undergo surgery, placed waiting list for two years." Id. '129, citing study Ex. 23.The study found that patients who underwent surgery "demonstrated dramatically improved psychosocial outcomes, compared the stillwaiting controls" and "were more active socially and had significantly fewer psychiatric symptoms." Id.; see also VP ATH Br. (study found "comparative improvements neurotic symptoms and social activity for the group receiving surgery"). Dr. Ettner described the 1990 study the "best example well-controlled investigation." Ettner Deel. 29. Dr. Ettner also described 1987 study comparing transsexuals who had undergone surgery with "those who had not, but were otherwise matched (control group)" finding that "the patients who underwent surgery were better adjusted psychosocially, had improved financial circumstances, and reported increased satisfaction with sexual experiences, compared the unoperated group." id. i 30, citing study Ex. 17. Steven Weyers, M.D., al., Long-term Assessment the Physical, lvfental, and Sexual Health Among Transsexual Women, Sex. Med. 752-60 (2009). Luk Gijs Anne Brewaeys, Surgical Treatment Gender Dysphoria Adults and Adolescents: Recent Developments, Effectiveness, and Challenges, Ann. Rev. Sex Res. 78-224 (2007). Ciro Imbimbo, M.D. Ph.D., al., Report from Single Institute 14-Year Experience Treatment Male-to-Female Transsexuals, Sex. Med. 2736-45 (2009). Svetlana Vujovic, M.D. Ph.D., al., Transsexualism Serbia: Twenty-Year Follow-Up Study, Sex. Med. 1018-23 (2009). Charles Mate-Kole, al., Controlled Study P5ychological and Social Change After Surgical Gender Reassignment Selected lvfale Transsexuals, 157 Brit. Psychiatry 261-64 1990). Follow Kockott, M.D. Fahrner, Ph.D., Transsexuals J!Vho Have Not Undergone Study, Archives Sexual Behavior 511-22 (1987). Nothing the record puts into question the authoritativeness the studies cited the nev evidence based methodology (or any other ground). Even questions about methodology had been raised, would hard pressed find that this alone would justify our not crediting the new evidence that transsexual surgery efiective and safe. This particularly true since the 1981 report itself suggested might impossible find the kind adequate control groups needed assuage this criticism. See NCD Record (stating the need for adequate control groups and stating "perhaps this impossible."). evidence available." 08, Ch. 13, 13.7.l.authoritative evidence derived from definitive randomized clinical trials other definitive studies .," also includes evidence meeting that standard, "[g]eneral acceptance the medical community (standard practice), supported sound medical evidence Id. Factor, DAB No. 2315 (2010), the Board relied that guidance when rejecting the 34. While the guidance applies CMS' determination the type evidence that may support Medicare coverage. Regardless whether the new evidence here meets the first option for meeting the evidentiary standard set forth the guidance (and CMS does not assert that does not), for transsexualism appropriate cases. expert medical opinion (i.e., recognized authorities the field); ... ]edical opinion derived from consultations with medical associations other health care experts." MPIM 13.7. The new evidence indicates that the NCD rationale for considering tile surgery experimental not valid. The NCD asserted that transsexual surgey was considered experimental because had not been shown safe and effective.3j The 1981 report stated that transsexual surgery "must considered still experimental" because "[t]he safety and effectiveness transsexual surgery treatment transsexualism not proven and questioned." NCD Record 19. discussed above, the unchallenged new evidence indicates that transsexual surgery safe and effective treatment option for transsexualism appropriate cases. Accordingly, the NCD's reasons for asserting that transsexual surgery was experimental are longer valid. considered experimental broader sense relating its acceptance treatment for transsexualism. Dr. Bowers stated that m]any thousands gender corrective surgeries have been performed worldwide for decades, and this treatment way experimental." Bowers Letter Dr. Hsiao testified that there "no scientific medical basis for [the NCD's] description gender affirming surgeries 'experimental."' Hsiao Deel. 22. Dr. Hsiao, noted, stated that some the procedures involved transsexual surgery are routinely performed other contexts, and that surgery create ncovagina performed women born MRKH. Hsiao Deel. ,-iii 11, 12; see Ettner Supp. Deel. ("mastectomies, hysterectomies and salpingooophorectomies, which are ... excluded from coverage under [the NCD] arc performed frequently ... when indicated for medical conditions other than gender dysphoria"). Dr. Hsiao cited the "increasing coverage sex affirming surgeries private and public medical plans and the inclusion those surgeries "in prominent surgical text books" showing that "gender affirming surgeries ... are the standard care and are not experimental." Id. iii! 23, 24. Dr. Hsiao cited California managed care guidance "clarifying that any attempt 'to exclude insurance coverage transsexual surgery"' Washington, D.C. "have issued similar insurance directives prohibiting discrimination based gender identity with respect healthcare policies." Id. 25, citing Letter No. 12-K: Gender Nondiscrimination Requirements, Calif. Dep't Managed Health Care procedures and attendant therapies for transsexualism, the treatment considered experimental." NCD Record 93. (Apr. 2013), Ex. Hsiao Decl."These events the private and public sector," Dr. Hsiao stated, "solidify what the medical community has known for years-that gender affirming surgeries treat gender dysphoria are evidence-based, medically necessary, and the standard care for these patients." Dr. Leis stated that gender reassignment surgery "is not experimental and has been performed thousands times with surgeons around the world and has been proven medically necessary and successful treatment, saving many lives and significantly improving the lives those who undergo this surgery." Leis Letter Dr. Leis also stated that "[m]edical and mental health professionals who are knowledgeable and experienced this field recognize that counseling psychotherapy, hormone therapy and genital reassignment surgery are medically necessary treatment modalities for many individuals with [GID]" and that those therapies "are widely accepted treatments for individuals with significant [GID] the United States and many other countries." Id. Dr. Leis also pointed the acceptance transsexual surgery procedures "as standard therapy leading medical and mental health organizations'' including the American Medical Association, the National Association Social Workers, the American Psychological Association, the American Psychiatric Association, "and experts the field belonging to" \lPATH. Id. HRC stated that its "Corporate Equality Index" annually surveys the "LGBT [lesbian, gay, bisexual and trans gender] workplace policies" "the Fortune 1000 list the largest publicly traded companies along with American Lawyer Magazine's top 200 revenuegrossing law firms" and considers "whether these organizations afford transgenderinclusive health care options through least one firm-wide plan that covers surgical procedures." HRC Br. 11-12. HRC stated that 2002, "zero percent the rated companies had such plans" but "by 2008, nineteen percent met this criterion, and 2013, forty-two percent companies expressly covered" care related gender reassignment. Id. citing HRC Ex. 30, 28.37 Dr. Bowers, Dr. Hsiao and Dr. Ettner cited acceptance the WPATH standards care, which were first published 1979 and last revised 2011, evidence that transsexual surgery not experimental. Bowers Letter Hsiao Deel. 22; Ettner Deel. accessed April 25, 2014. the WPA standards care have attained widespread acceptance. See Hsiao Deel. ("the established standards care for patients with gender dysphoria ... have been endorsed the American Medical Association, the Endocrine Society, the American Psychological Association, and the American College Obstetricians and Gynecologists"); Ex. (AMA resolution stating that "the leading international, interdisciplinary professional organization devoted the understanding and treatment gender identity disorders" and that its "internationally accepted Standards Care for providing medical treatment for people with GID ... are recognized within the medical community the standard care for treating people with GTD"). Federal courts have recognized the acceptance the WPA standards care. See, e.g., 'lonta Johnson, 708 F.3d 520, 522-23 (4th Cir. 2013) (WPATH standards care "are the generally accepted protocols for the treatment GID"); Glenn Brumby, 724 Supp. 1284, 1289 n.4 (N.D. Ga. 2010) ("there sufficient evidence that statements WPATH are accepted the medical community")."39 The acceptance the ATH standards care also suggests that transsexual surgery longer considered experimental. its amicus brief: ATH cited 2007 study that examined the results studies published between 1990 and 2006 showing "that [sex reassignment surgery] can longer considered experimental treatment" and that "it [has] bee[ ]me the dominant treatment for transsexuality and the only treatment that has been evaluated empirically." WPATH Br. 7-8, citing Ex. 10, 214-15.40 note that addition stating that transsexual surgery was experimental, the NCD and the 1981 report stated that transsexual surgery was "controversial." NCD Record 1981 report stating that ]ver and above the medical and scientific issues, would also appear that transsexual surgery controversial our society"). The and the new evidence dispute the relevance this statement. The objected that this point relies two "polemics" that are "are either completely unscientific fall far outside the scientific mainstream," and Dr. Ettner stated that the views expressed therein "fall far outside the mainstream psychological, psychiatric, and medical professional consensus, WPATH was "formerly the Harry Benjamin International Gender Dysphoria Association." Ettner Deel. 'if Harry Benjamin, M.D. "was endocrinologist who conjunction with mental health professionals New York did pioneering work the study transsexualism." 'Donnabhain Comm Internal Revenue, 134 T.C. 34, n.8 (20 0). The 1981 report cites 1966 study Dr. Benjamin finding positive outcome from transsexual surgery "perhaps the first report" transsexual surgery "in the literature." NCO Record 15, 21. The general acceptance set standards care for the treatment transsexuals appears render invalid one the 1981 report criticisms the studies discussed, that "therapeutic techniques are not standardized." NCD Record 18. Luk Gijs Anne Brewaeys, Surgical Treatment Gender Dysphoria Adults and Adolescents: Recent Developments, Effectiveness, and Challenges, Ann. Rev. Sex Res. 178-224 (2007). For the reasons explained above, conclude that the has shown that NCD 140.3 not valid under the reasonableness standard. Overview the Scientific Literature the New Evidence reviewed the Board new evidence. The key findings the remaining studies reviewed the Board (also new evidence) not differ any way material our decision. instability before operation correlated with unsatisfactory outcome sex reassignment." Id. 39, 44, 45. Luk Gijs Anne Brewaeys, Surgical Treatment Gender Dysphoria Adults and Adolescents: Recent Developments, Effectiveness, and Challenges, Ann. Rev. Sex Res. 178-224 (2007), Ex. 10. This study examined results international studies published between 1990 and 2006 that reported follow-up data least one year from 807 persons who had undergone sex reassignment surgery (193 FM, 614 MF). The purpose this study was update and assess the current validity conclusion transsexual surgery effective treatment for the alleviation gender disorder adults. This study concluded that d]espite methodological shortcomings many the studies ... SRS effective treatment for transsexualism and the only treatment that has been evaluated empirically with large clinical case series" and that the "conclusion that [sex reassignment] the most appropriate treatment alleviate the suffering extremely gender dysphoric individuals still stands: 96% the persons who undenvent SRS were satisfied and regret was rare." The authors noted that the methodologies and designs later studies were improved but that true randomized control studies are not feasible, and might unethical for SRS. Id. 178, 185, 215-16. Ciro Imbimbo, M.D. Ph.D., al., Reportfrom Single Institute 14-Year Experience Treatment Male-to-Female Transsexuals, Sex. Med. 2736-45 (2009), Ex. 13. This study' aim was "to arrive clinical and psychosocial profile male-tofemale transsexuals Italy through analysis their personal and clinical experience and evaluation their postsurgical satisfaction levels SRS." From January 1992 September 2006, 163 patients who had undergone SRS were asked complete patient satisfaction questionnaires. The study concluded that the "relatively high satisfaction level was the result combination "competent surgical skills, wellconducted preoperative preparation program, and adequate postoperative counseling .... Although postoperative pain and required revision surgeries were reported, the study found that 94% were satisfied with their post-surgical status and did not report regret. Id. 2736, 2740, 2743. Ladislav Jarolim, al., Gender Reassignment Surgery Male-to-Female Transsexualism: Retrospective 3-Month Follow-up Study with Anatomical Remarks, J.Sex. Med. 1635-44 (2009), Ex. 14. This study aimed "[t]o evaluate the results surgical reassignment genitalia male-to-female transsexuals" measuring "[s]exual functions and complications months after surgery." The study followed 134 patients who had undergone surgical procedures between 1992 and 2008 and described the evolution surgical techniques since the 1950s. Although the study noted potential complications and risks specific SRS ("such impairment urinary continence, fecal continence, intestinal fistula, urinary fistula, and necrosis the skin graft"), concluded that ]urgical conversion the genitalia safe and important phase the treatment male-to-female transsexuals." also concluded that a]n increasing number patients undergo this treatment because the extensive progress surgery involving the genitals and urethra and that f]or male transsexuals, surgery can provide cosmetically acceptable imitation female genitals that enables coitus with orgasm." Id. 1635-36,1642-43. Annika Johansson, al., Five-Year Follow-Up Study Swedish Adults with Gender Identity Disorder, Arch. Sex. Behav. 1429-37 (2010), Ex. 15. This study evaluated from the perspective both clinicians and patients the outcome sex reassignment "42 [MF and FM] transsexuals [who completed follow-up assessment after more years the process more years after completed sex reassignment surgery." found that "the outcome was very encouraging from both perspectives ... with almost 90% enjoying stable improved life situation follow-up and only six out (according the clinician) with less favorable outcome." Id. 1429, 1436. Kockott, M.D. Fahrner, Ph.D., Transsexuals Who Have Not Undergone Surgery: Follow-Up Study, Archives Sexual Behavior 511-22 (1987), Ex. 17. This single-clinic study compared transsexuals who sought but did not undergo surgery with who did; psychosocial adjustment those who delayed surgery did not improve from the time diagnosis follow-up while statistically significant positive changes gender role, sexual, and socioeconomic adjustment were seen transsexuals who had had surgery. Id. 511, 517-19, 521. Anne Lawrence, Patient-Reported Complications and Functional Outcomes Maleto-Female Sex Reassignment Surgery, Arch. Sex. Behav. 717-27 (2006), Ex. 21. This study "examined preoperative preparations, complications, and physical and functional outcomes [MF SRS] based reports 232 patients, all whom underwent penile-inversion vaginoplasty and sensate clitoroplasty, performed one surgeon using consistent technique," who were surveyed mean three years after surgery. The study found that "[r]eports significant surgical complications were uncommon," although one third had urinary stream problems, and that "[o[n average, participants expressed high levels satisfaction with nearly all the specific physical and functional outcomes SRS." Id. 717, 719, 724. Maria Ines Lobato, al.,Follow-Up Sex Reassignment Surgery Transsexuals: Brazilian Cohort, Arch. Sex. Behav. 711-15 (2006), Ex. 22. This small study examined the "impact sex reassignment surgery satisfaction with sexual experience, partnerships, and relationship with family members ... patients who received sex reassignment between 2000 and 2004." The results "indicate[d] that SRS had positive effect different dimensions the patients' lives all three aspects analyzed: sexual relationships, partnerships, and family relationships." Id. 711-12, 714. Charles Mate-Kole, al.,A Controlled Study Psychological and Social Change after Surgical Gender Reassignment Selected Male Transsexuals, 157 Brit. Psychiatry 261-64 (1990), Ex. 23. This study reviewed patients accepted for gender reassignment surgery, randomly assigned have surgery early later such that only half had had surgery the time follow-up two years later. The study found that "[a]lthough the groups were similar initially, significant differences between them emerged follow-up .... Patients who received surgery were "seen improve significantly far neurotic symptoms are concerned and become more socially active comparison with the patients who had not yet received surgery. Id. 261, 264. Friedemann Pfafflin Astrid Junge, Sex Reassignment: Thirty Years International Follow-Up Studies After Sex Reassignment Surgery: Comprehensive Review 19611991 (Roberta Jacobson AlfB. Meier trans., 1998) (1992), Ex. 25. This overview was completed 1992 and published English 1998. reviewed "30 years international follow-up studies approximately two thousand persons who had undergone sex reassignment surgery," including "more than individual studies and eight published reviews from four continents." general, more frequent and severe complications were found the earlier years covered than later reports. The overview concluded that Jex reassignment, properly indicated and performed, has proven valuable tool the treatment individuals with transgenderism," that "gender reassigning treatments are effective and that "the treatment that includes the whole process gender reassignment effective." Id. unnumbered pages 45, 66-67. Yolanda L.S. Smith, al., Sex Reassignment: Outcomes and Predictors Treatment for Adolescent and Adult Transsexuals, Psycho!. Med. 89-99 (2005), Ex. 27. This study evaluated "outcomes sex reassignment, potential differences between subgroups transsexuals, and predictors treatment course and outcome" 162 adults (104 MF, FM). The study found that "[a]fter treatment the group was longer gender dysphoric," had ''improved important areas function, that 1-4 years after surgery, appeared therapeutic and beneficial ... [and that] the vast majority expressed regrets about their SR." The study further concluded "that sex reassignment effective" but that "clinicians need alert for non-homosexual male-to-females with unfavourable psychological functioning and physical appearance and inconsistent gender dysphoria Id. 89, 91, 96. Svetlana Vujovic, M.D., Ph.D., al., Transsexualism Serbia: Twenty-Year FollowUp Study, Sex. Med. 1018-23 (2009), Ex. 29. This study [a]imed "describe transsexual population seeking sex reassignment treatment Serbia" analyzing "data collated over period years" from transsexuals "applying for sex reassignment'' whom SRS was performed 83% and 77% patients. The study concluded that ''in our population, there were cases who regretted sex reassignment treatment," which was attributed diagnostic procedures used and the "young [adult] age which our subjects embarked treatment." Id. 1018-20, 1022. Steven Weyers, M.D., al., Long-term Assessment the Physical, lvfental, and Sexual Health Among Transsexual Women, Sex. Med. 752-60 (2009), Ex. 30. This study [a]imed "[t]o gather information physical, mental, and sexual well-being, healthpromoting behavior and satisfaction with gender-related body features 49] transsexual women [MF] who had undergone SRS" with mean interval since vaginoplasty 75.46 months. The study found that "sample ... functions well after surgery physical, emotional, psychological and social level" and that ]nly with respect sexuality transsexual women appear suffer from specific difficulties, especially concerning arousal, lubrication and pain." Id. 752, 754, 759.