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Genital Reassignment Surgery for Transsexual Women

Medically Necessary?. Genital Reassignment Surgery for Transsexual Women. Sexual Health Scholars Program March 2010. Goals. Develop an informed understanding of the genital surgery options available to transsexual women

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Genital Reassignment Surgery for Transsexual Women

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  1. Medically Necessary? Genital Reassignment Surgery for Transsexual Women Sexual Health Scholars Program March 2010

  2. Goals • Develop an informed understanding of the genital surgery options available to transsexual women • Evaluate Genital Reassignment Surgery (GRS) in terms of the criteria established for medically necessary procedures • Describe the status and availability of GRS in this country and suggest appropriate changes

  3. Outline • I. Overview of male-to-female genital surgeries • Technique, goals, eligibility • II. Determining “medical necessity” • III. Surgical outcomes and patient benefit • subjective • objective • regret • complications • IV. State of care in the US • providers • cost • coverage and exclusions • policy statements • court cases • V. Analysis and next steps

  4. Overview of Procedures • MTF genital surgery is intended to create a genital region that is as functionally and aesthetically feminine as possible, including • depth of 10 cm and diameter of 3 cm or more • lining of moist, hairless epithelium • sufficient sensation for satisfactory intercourse • shortened urethra and downward urinary stream • surgical sites free of obvious scars and absent of complications such as stenosis and fistulas (Karim, Hage and Mulder, 1996) • Typically consists of orchiectomy, penectomy, vaginoplasty, urethroplasty, clitoroplasty, and labiaplasty performed in 1-2 operations • Most popular approach involves penile inversion, but rectosigmoid grafts are also used

  5. Intended Outcomes • Primary Benefits • reduced gender dysphoria • improved mental health • Secondary Benefits • comfortable intimate relationships • comprehensive physical examinations bearable • swimsuits and other types of clothing are practical • legal documents that reflect the patient’s identity

  6. Eligibility for Surgery • Patients must fulfill guidelines set forth by their would-be surgeons; many surgeons follow the WPATH guidelines: • Legal age of majority • 12 months continuous hormone therapy* • 12 months of full-time real life experience • Evaluation and recommendation for surgery by two mental health professionals** • Regular psychotherapy if required by the mental health professionals • many surgeons also require genital electrolysis be performed Insurers likely to require a diagnosis of Gender Identity Disorder as described in the DSM IV *requirement for hormone therapy may be waived if medically contraindicated **the evaluating therapists must generally have a master’s degree or higher in psychology, psychiatry, social work, counseling or a related field; one writer should know the patient for one-year or more, the other letter may be a brief concurrence

  7. Medical Necessity • Medicare: Services or supplies that are needed for the diagnosis or treatment of your medical condition, meet the standards of good medical practice in the local area, and aren’t mainly for the convenience of you or your doctor. • AMA: Health care services or products that a prudent physician would provide to a patient for the purpose of preventing, diagnosing, or treating an illness, injury, disease or its symptoms in a manner that is: (a) in accordance with generally accepted standards of medical practice; (b) clinically appropriate in terms of type, frequency, extent, site and duration; and (c) not primarily for the convenience of the patient, physician, or other health care provider. 

  8. CIGNA: … health care services that a Physician, exercising prudent clinical judgment, would provide to a patient for the purpose of evaluating, diagnosing or treating an illness, injury, disease or its symptoms… • CIGNA: “generally accepted standards of medical practice” are determined by… • standards that are based on credible scientific evidence published in peer-reviewed, medical literature generally recognized by the relevant medical community; • physician specialty society recommendations; • the views of physicians practicing in the relevant clinical area; and • any other relevant factors.

  9. Surgical Outcomes: UK Experience • Mate-Kole, Freschi and Robin, 1988 • Three groups of transsexuals (new patients, placed on a waiting list for GRS, and ½-2 years post-op) were compared across six areas of psychological functioning; the wait list group had significantly less somatic anxiety and depression, while the post-op group faired significantly better in all areas. • The authors concluded: “…the difference in CCEI score from assessment level is greater after surgery than after simple change of gender role, and that the direction of the differences is towards progressive improvement during treatment…”

  10. Mate-Kole, Freschi and Robin, 1990 • 40 patients randomly divided into an early treatment group and delayed treatment group were compared after two years, when the early group was post-surgery and the late group was still awaiting surgery • The groups were similar initially, but the post-op group showed improvements from baseline and in comparison to the delayed group; the authors noted, “all scores on the CCEI increased in the unoperated group and fell in the operated group” • Other differences included significant increases in social and sexual activity and a higher rate of employment

  11. Netherlands Experience • Smith, van Goozen, and Cohen-Kettenis, 2001 • 20 adolescents (13 FM and 7 MF) who underwent surgery (treated group) were studied in terms of gender dysphoria and psychological functioning; post-operative results were compared to pre-operative results; treatment (T) group was also compared to group of 14 persons who applied for surgery but were not approved (NT) • GRS effectively reduced the treated adolescents’ gender dysphoria. No person regretted surgery. • The T group showed significant improvement in several areas of the SCL-90, while there were no significant changes for the NT group • Overall SCL-90 scores fell in the high range for the T group before treatment but fell to “above average” post-operatively and NVM scores were normal (data summarized on next page) • Results supported similar data published earlier by the same group (see Cohen-Kettenis and van Goozen, 1997).

  12. Smith, van Goozen, and Cohen-Kettenis, 2001

  13. Smith, van Goozen, Kuiper, and Cohen-Kettenis, 2005 • Prospective study of 77 transsexual women and 49 transsexual men who completed GRS • Authors concluded “1-4 years after surgery, SR [Sex Reassignment] appeared therapeutic and beneficial. Furthermore, the vast majority expressed no regret about their SR” (p. 96). • Gender dysphoria and body dissatisfaction decreased significantly (p < .001), while physical appearance was felt to better match gender • Psychological functioning showed improvement • Negativism, shyness, psychoneuroticism, anxiety, depression, inadequacy and sensitivity improved significantly (p < .001) • Somatization, psychopathology and extroversion were improved (p < .006)

  14. Smith, van Goozen, Kuiper, and Cohen-Kettenis, 2005

  15. Other Experiences • Rakic, et al, 1996, n=22 • Before surgery, 0% were satisfied with relationships; after surgery, 50% were satisfied and 32% were satisfied to some extent • De Cuypere, et al, 2005, n=29 • Comparison of sex life: 75.8% improved, 10.3% neutral, 13.8% worsened • Satisfaction with GRS: 48.3% very satisfied, 37.9% satisfied, 10.3% neutral, 0% unsatisfied, 3.4% very unsatisfied • the 1 unsatisfied patient reported a poor surgical result (shallow vagina) • Lawrence, 2001, n=232 • On a scale of 0-10, the average happiness with SRS was 8.7, and on a scale from -10-10, improvement in quality of life was 7.9. (Belgrade) (Belgium) (USA)

  16. Pfafflin and Junge, 1998 • Large meta-analysis of cross-country studies from 1961-1991 (over 2000 patients total) • Positive outcomes studied were subjective satisfaction, mental stability, socioeconomic functioning and sexuality • Negative outcomes studied were surgical complications, suicide and regret • Subjective improvement and improved mental health status were reported in nearly all studies; 14 cases of regret were reported, most of which the authors felt were avoidable with proper screening • Green and Fleming, 1990 • Also a meta-analysis, considered only studies after 1980, found an 87% satisfaction rate • Interestingly, Pfafflin and Junge’s analysis summarized the Green and Fleming study as follows: “The authors protest the policy of many private health insurance firms in the USA that deny to take over the costs for surgical treatment by claiming that they are cosmetic and/or experimental treatments. To call such procedures cosmetic is considered, in view of the suffering of patients, as cynical; to call the classification experimental is untrue, in view of the circumstances that such surgery is established in many centers inside and outside the USA and -- as is to be seen by follow-up studies -- has proven worthy. Other surgeries, such as liver and heart that are covered by insurance without question, are much more experimental. “

  17. Regret • Rates of regret • Smith, van Goozen, Kuiper, and Cohen-Kettenis, 2005: 1.6% of • Lawrence, 2003: 7 w/ QOL unchanged, 1 w/ QOL ; 3% of 232 patients • Landen, Walinder, Hambert, and Lundstrom, 1998: 3.8% of 218 patients • Predictors of regret • poor surgical results, lack of acceptance or support, prior psychotic disorder, non-transsexual, gynophilic sexual orientation Landen, et al, 1998

  18. Potential Complications • Bleeding • Infection • Poor cosmetic result • Misdirected urinary stream – 33%* • Anorgasmia – 18% • Vaginal stricture – 8% (prevent with dilation) • Intervaginal hair growth – 7% (prevent with depilation) • Urethral stenosis – 4% • Clitoral necrosis – 3% • DVT – 0% (cease estrogen prior to surgery or anticoagulate) • Vaginal prolapse – 0% • Recto-vaginal fistula – 0% *Frequencies from Lawrence, 2006 (n=232) Bowman and Goldberg, 2006

  19. Meta-Analysis of Complications, Lawrence, 2006

  20. Providers and Fees • US Surgeons performing vaginoplasty and cost estimate* as of March 2010 • Alter ($35,000) • Bowers ($22,000) • Leis ($19,350) • McGinn ($17,500) • Meltzer ($23,000) • Reed ($16,500) *Costs are comprehensive (include surgeon’s fees, OR, anesthesia and recovery)

  21. Government Health Plans • Medicaid (low-income persons) and Medicare (>age 65 or disabled) are state-administered federal healthcare programs for vulnerable populations • Medicaid: no federal ban on GRS, but 24 states explicitly deny coverage and no state explicitly covers it; in years past a small number of people have undergone Medicaid-funded GRS, but this is becoming increasingly difficult if not impossible; also, many surgeons will not accept Medicaid’s low reimbursement rates or require upfront payments • Medicare: A federal policy denies coverage of GRS in all states, allegedly due to uncertainty regarding the “safety and effectiveness of the surgical procedures” and a “high rate of serious complications” • VA and CHAMPUS explicitly deny coverage as well

  22. Private insurance • Only a small percentage of private insurance plans offer coverage for GRS; however, many insurers will offer the benefit if it is requested by the employer • 12% (66) of CEI-ranked* businesses offered coverage for GRS in 2010 • 3M, Aetna, American Express, AT&T, Cisco, Coca-Cola, Kodak, Ford, Genentech, Goldman Sachs, Google, IBM, etc. • A small number of universities and the city government of San Francisco also have changed policies • University of California, University of Michigan, Stanford *590 of the Fortune 1000 businesses rated by the Human Rights Campaign

  23. Typical language used to exclude coverage for GRS (from Human Rights Campaign)

  24. Implementation of Coverage • San Francisco experience: • In 2001, city government of SF initiated a plan to provide its employees with access to transsexual surgery • A $1.70 monthly surcharge was added to insurance plans; from July 2001 to July 2004, approximately $4.3 million dollars were collected and $156,000 were paid out for 7 claims (SF HRC, nd) • “Despite actuarial fears of over-utilization and a potentially expensive benefit, the Transgender Health Benefit Program has proven to be appropriately accessed and undeniably more affordable than other, often routinely covered, procedures.” (HRC, 2008) • Lucent experience: • Initiated coverage in 2000 • Two employees underwent GRS between 2000 and 2003 at a combined cost of approximately $20,000 • Given Lucent’s 33,000 employees, the per person cost for offering GRS benefits was estimated to be $0.61 (Horton, 2008)

  25. National estimates of cost • In 2001, US residents spent approximately $7.63 million on MTF GRS (Horton, 2008) • If this expenditure were divided among the insured US population, the per person cost would be 5.5 cents, and 7.9 cents if only US surgeons were used (Horton, 2008) • GRS currently comprises less than 0.0009% of the total US expenditure on health care • Clearly the solution to rising health care costs does not lie in excluding coverage of GRS

  26. AMA • Resolution 122 (excerpts): • Whereas, 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… • RESOLVED, That our American Medical Association support public and private health insurance coverage for treatment of gender identity disorder (New HOD Policy); and be it further • RESOLVED, That our AMA oppose categorical exclusions of coverage for treatment of gender identity disorder when prescribed by a physician.

  27. APA • APA Policy Statement: Transgender, Gender Identity, & Gender Expression Non-Discrimination (excerpts): • APA supports the provision of adequate and necessary mental and medical health care treatment for transgender and gender variant individuals; • 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;

  28. WPATH • Clarification on medical necessity of treatment, sex reassignment, and insurance coverage in the USA (excerpt): • "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.“ • “The WPATH Board of Directors urges health insurance carriers and healthcare providers in the United States to eliminate transgender or trans-sex exclusions and to provide coverage for transgender patients and the medically prescribed sex reassignment services necessary for their treatment and wellbeing…”

  29. Pinneke v. Preisser, 1980: • “The decision of whether or not certain treatment or a particular type of surgery is "medically necessary" rests with the individual recipient's physician and not with clerical personnel or government officials.” • “The regulations permit discrimination in benefits based upon the degree of medical necessity but not upon the medical disorders from which the person suffers." (Footnote omitted.) Here Pinneke proved a real need for the only medical service available to alleviate her condition, and the record indicates her condition has improved since the surgery.” • JD v. Lackner, GB v. Lackner, 1978: • "We do not believe, by the wildest stretch of the imagination, that such surgery can reasonably and logically be characterized as cosmetic.“ • "the only evidence presented in this case was that the surgery was necessary and reasonable.“ (as quoted in Gordon, 1991, p.67)

  30. O’Donnabhain v. Commissioner, 2010: • Given Dr. Brown’s expert testimony, the judgment of the professional treating petitioner, the agreement of all three experts that untreated GID can result in selfmutilation and suicide, and, as conceded by Dr. Schmidt, the views of a significant segment of knowledgeable professionals that sex reassignment surgery is medically necessary for severe GID, the Court is persuaded that petitioner’s sex reassignment surgery was medically necessary. • “Petitioner has shown that her hormone therapy and sex reassignment surgery treated disease within the meaning of section 213 and were therefore not cosmetic surgery. Thus petitioner’s expenditures for these procedures were for “medical care” as defined in section 213(d)(1)(A), for which a deduction is allowed under section 213(a).” Other cases concerning medical necessity of GRS: Meriwether v. Faulkner, 821 F.2d at 412; Pinneke v. Preisser, 623 F.2d at 548; Sommers v. Iowa Civil Rights Commn., 337 N.W.2d at 473; Doe v. Minn. Dept. of Pub. Welfare, 257 N.W.2d at 819; Davidson v. Aetna Life & Cas. Ins. Co., 420 N.Y.S.2d at 453.

  31. Cost-Benefit Analysis A hypothetical patient with severe GID* • Cost: • $25,000 • Saves $205,000 in 10 years compared to “no GRS” GRS no GRS patient quickly returns to functional status patient remains depressed and poorly functional • Cost: • weekly counseling ($1200/month) • anti-depressants ($300/month) • welfare payments ($10,000/year) • lost tax revenue ($5,000/year) • Total societal cost of $15,000/year • Health Insurer cost of $8,000/year *For a real-life example of such a scenario, see the Seattle Times article “Tax dollars and a sex change: a story of one patient”

  32. Is the CIGNA definition met? • Treating an established medical condition? • Yes • Credible scientific evidence in the peer-reviewed medical literature? • Yes • Physician specialty society recommendations? • Yes • The view of physicians practicing in the clinical area? • Yes

  33. Are Exclusions Justified? • Experimental? • No, 1000s of successful operations have been performed over decades with ongoing refinements; GRS is safer than other surgeries that are routinely provided • Cosmetic? • No, surgery is reconstructive • Unnecessary? • No, it is often necessary for the health and wellbeing of the patient

  34. Summary and next steps • Relevant professional societies and a variety of US courts as recently as February, 2010 have stated that genital reassignment surgery meets the criteria of “medically necessary” • The bulk of evidence from scholarly studies also shows that surgery is technically feasible and highly beneficial to patients • However, access to GRS remains extremely limited for the large majority of transsexual women • Health care providers should advocate that government health plans (Medicare and Medicaid) as well as private insurers routinely offer GRS to qualified patients • Providers should also assist individuals attempting to access these services by providing appropriate documentation and support • More providers should undergo training to provide these services so that techniques continue to improve and prices fall

  35. References Surgeons' Websites Dr. Gary Alter - http://www.altermd.com/ Dr. Marci Bowers - http://marcibowers.com/grs/payment.html Dr. Sherman Leis - http://www.thetransgendercenter.com/ Dr. Christine McGinn - http://drchristinemcginn.com/services/srs/vaginoplasty.asp Dr. Toby Meltzer - http://www.tmeltzer.com/procedures/mtf.shtml Dr. Harold Reed - http://www.srsmiami.com/MTF-male-to-female.html Other Websites Medically Necessary Definition, CIGNA: http://www.cigna.com/health/provider/medical/procedural/medical_necessity.html#hc_def Retrieved March 2nd 2010. Medically Necessary Definition, AMA: www.ama-assn.org/ama/upload/mm/372/i99cms13doc.doc Retrieved March 2nd 2010. Medically Necessary Definition, Medicare: http://ww.medicare.gov/Glossary/search.asp?Language=English&SelectAlphabet=M Retrieved March 2nd 2010.

  36. Horton, 2008. Cost of transgender health benefits. Out and Equal Workplace Summit. Retrieved August 8th 2009 from <http://www.tgender.net/taw/thb/THBCost-OE2008.pdf>. HRC Equality Index 2010 http://www.hrc.org/documents/HRC_Corporate_Equality_Index_2010.pdf Retrieved March 15th 2010. Health insurance discrimination for transgender people, HRC http://www.hrc.org/issues/9568.htm Retrieved March 2nd 2010. HRC Corporate Equality Index 2008, pdf http://www.hrc.org/documents/HRC_Corporate_Equality_Index_2008.pdf Retrieved March 15th 2010. San Francisco City and County Transgender Health Benefit http://www.hrc.org/documents/San_Francisco_City_and_County_Transgender_Health_Benefit_-_2007-08-10.pdf Retrieved March 15th 2010. Position Statements/Court Cases WPATH Statement on Medical Necessity http://www.wpath.org/documents/Med%20Nec%20on%202008%20Letterhead.pdf Retrieved March 2nd 2010.

  37. AMA Statement http://www.tgender.net/taw/ama_resolutions.pdf Retrieved March 2nd 2010. APA Statement http://www.apa.org/about/governance/council/policy/transgender.aspx Retrieved March 2nd 2010. Pinneke v Preisser http://openjurist.org/623/f2d/546/pinneke-v-preisser Retrieved March 15th 2010. O'Donnabhain v. Commissioner. 134 TC 4, (2010). http://www.ustaxcourt.gov/InOpHistoric/ODonnabhain.TC.WPD.pdf Retrieved March 15th 2010. Gordon, E. B., 1991. Transsexual healing: Medicaid funding of sex reassignment surgery. Archives of Sexual Behavior, 20(1), 61-72. Meyer III, et al, 2003. The Harry Benjamin International Gender Dysphoria Association's Standards Of Care For Gender Identity Disorders, Sixth Version. <http://www.wpath.org/Documents2/socv6.pdf>

  38. Journal Articles De Cuypere, et al, 2005. Sexual and physical health after sex reassignment surgery. Archives of Sexual Behavior 34(6):679-690. Jones, Schirmer and Hoopes, 1968. A sex conversion operation for males with transsexualism. American Journal of Obstetrics and Gynecology 100:101-109. Kim, Park, Lee, Park, Kim and Kim, 2003. Long-term results in patients after rectosigmoid vaginoplasty. Plastic and Reconstructive Surgery 112(1):143-151. Kuiper, B., & Cohen-Kettenis, P., 1988. Sex reassignment surgery: A study of 141 Dutch transsexuals. Archives of Sexual Behavior, 17(3), 439-457. Landen, M., Walinder, J., Hambert, G., & Lundstrom, B., 1998. Factors predictive of regret in sex reassignment. Acta Psychiatrica Scandinavica, 97. 284-289. Lawrence, A. A., 2003. Factors associated with satisfaction or regret following male-to- female sex reassignment surgery. Archives of Sexual Behavior, 32(4), 299-315. Lawrence, A. A., 2006. Patient-reported complications and functional outcomes of male-to-female sex reassignment surgery. Archives of Sexual Behavior, 35:717-727. Mate-Kole, C., Freschi, M., & Robin, A., 1988. Aspects of psychiatric symptoms at different stages in the treatment of transsexualism. British Journal of Psychiatry, 152, 550-553.

  39. Mate-Kole, Freschi and Robin, 1990. A controlled study of psychological and social change after surgical gender reassignment in selected male transsexuals. British Journal of Psychiatry 157:261-264. Olsson, S., & Möller, A. (2006). Regret after sex reassignment surgery in a male-to- female transsexual: A long-term follow up. Archives of Sexual Behavior, 35(4), 501-506. Pfafflin and Junge, 1998. Sex Reassignment. Thirty Years of International Follow-up Studies After Sex Reassignment Surgery: A Comprehensive Review, 1961-1991. Retrieved January 5th 2010 from <http://web.archive.org/web/20070503090247/http://www.symposion.com/ijt/pfaefflin/1000.htm>. Rakic, Starcevic, Maric and Kelin, 1996. The outcome of sex reassignment surgery in Belgrade: 32 patients of both sexes. Archives of Sexual Behavior 25(5):515-525. Rehman and Melman, 1999. Formation of neoclitoris from glans penis by reduction glansplasty with preservation of neurovascular bundle in male-to-female gender surgery: Functional and cosmetic outcome. The Journal of Urology 161:200-206. Smith, Y. L. S., van Goozen, S. H. M., & Cohen-Kettenis, P. T. (2001). Adolescents with gender identity disorder who were accepted or rejected for sex reassignment surgery: A prospective follow-up study. Journal of the American Academy of Child Adolescent Psychiatry, 40(4), 472-481. Smith, Y. L. S., van Goozen, S. H. M., Kuiper, A. J., & Cohen-Kettenis, P. T. (2005). Sex reassignment: Outcomes and predictors of treatment for adolescent and adult transsexuals. Psychological Medicine, 35, 89-99.

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