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Horizon BCBSNJ
Uniform Medical Policy ManualSection:Drugs
Policy Number:141
Effective Date: 05/14/2019
Original Policy Date:07/15/2016
Last Review Date:05/14/2019
Date Published to Web: 07/15/2016
Subject:
Drug Therapy for Transgender Policy

Description:
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IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.

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Gender dysphoria, previously known as gender identity disorder, is a condition in which a person feels a strong and persistent identification with the opposite gender accompanied with a severe sense of discomfort in their own gender. People with gender dysphoria often report a feeling of being born the wrong sex or "trapped in the wrong body". Gender dysphoria is broadly defined as a discomfort or distress that is caused by a discrepancy between a person's gender identity and that person's sex assigned at birth (and the associated gender role and/or primary and secondary sex characteristics).9 The diagnosis of gender dysphoria can be established at childhood, adolescence, or adulthood. People who wish to change their sex may be referred to as "transsexuals".

In May 2013, the American Psychiatric Association published an update to their Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). This update included a significant change to the nomenclature of conditions related to gender psychology. Specifically, the term "Gender Identity Disorder (GID)" was replaced with "Gender Dysphoria".8 Additionally, the DSM-5 provided updated diagnostic criteria for gender dysphoria for both children and adults. However, ICD-9 and ICD-10 codes continue to use the term gender identity disorder.

Due to the far-reaching and irreversible results of hormonal and/or surgical transformational measures, a step-wise approach to therapy for GID, including accurate diagnosis and long-term treatment by a multidisciplinary team including behavioral, medical and surgical specialists, is vital to the patient's best interest. As with any treatment involving psychiatric disorders, a thorough behavioral analysis by a qualified practitioner is needed.

After the diagnosis of gender dysphoria is made, the therapeutic approach to gender dysphoria usually includes three elements or phases (sometimes labeled triadic therapy): hormones of the desired gender, a real-life experience in the desired role, and surgery to change the genitalia and other sex characteristics. The most typical order, if all three elements are undertaken, is hormones followed by real-life experience and, finally surgery to change the genitalia and other sex characteristics. However, the diagnosis of gender dysphoria invites the consideration of a variety of therapeutic options, only one of which is the complete therapeutic triad. Clinicians have become increasingly aware that not all persons with gender dysphoria need or want all three elements of triadic therapy. Hormone therapy is administered under medical supervision and is important in the gender transition process by altering body hair, breast size, skin appearance and texture, body fat distribution, and the size and function of sex organs. Additionally, real-life experience is important to validate the individual's desire and ability to incorporate into their desired gender role within their social network and daily environment. This generally involves gender-specific appearance (garments, hairstyle, etc.), involvement in various activities in the desired gender role including work and academic settings, legal acquisition of a gender appropriate first name, and acknowledgement by others of their new gender role.

The general approach for feminizing hormone therapy is to combine estrogen with an anti-androgen hormone. Suppression of male secondary sex characteristics and the addition of female secondary sex characteristics is the goal of feminizing hormone therapy. General effects include but are not limited to a reduction of muscle mass, reduction of body hair, breast development (usually to Tanner stage 2 or 3), change in sweat and odor patterns, and a redistribution of facial and body subcutaneous fat. Sexual and gonadal effects include changes in libido, reduced or absent sperm count and ejaculatory fluid, reduction in erectile function, and reduced testicular size. Changes in emotional and social functioning may also be brought about while feminizing hormone therapy.

The general approach for masculinizing hormone therapy is the use of one of several forms of parenteral testosterone. Suppression of female secondary sex characteristics and the addition of male secondary sex characteristics is the goal of masculinizing hormone therapy. General effects include but are not limited to increased muscle mass, increased body hair, change in sweat and odor patterns, development of facial hair, virilizing changes in voice, and a redistribution of facial and body subcutaneous fat. Sexual and gonadal effects include cessation of menses, increase in libido, and vaginal dryness. Changes in emotional and social functioning may also be brought about while masculinizing hormone therapy.

Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance)

[INFORMATIONAL NOTE: Please refer to policy on 'Gender Reassignment Surgery' (Policy #115 in the Surgery Section).]

I. Contract exclusions and/or limitations for gender reassignment surgery, including related services such as medical counseling, psychological clearance for surgery in the absence of a need for behavioral health therapeutic services, and hormonal therapy, will determine the available benefit for gender reassignment surgery.

II. For contracts that specify gender reassignment surgery and related services as a covered benefit and have specific benefit applications and/or limitations for gender reassignment surgery, such specific benefit applications and/or limitations will apply.

III. Coverage for GnRH and/or hormone therapy for adolescents is considered medical necessary for:

    A. GnRH use in Gender Dysphoria, when ALL of the following criteria are met:
      1. Fulfills the DSM V or ICD-10 criteria for gender dysphoria; and
      2. Has experienced puberty to at least Tanner stage 2; and
      3. Has (early) pubertal changes that have resulted in an increase of their gender dysphoria; and
      4. Does not suffer from a psychiatric comorbidity that interferes with the diagnostic work-up or treatment or mental health comorbidities must be reasonably well-controlled; and
      5. Has adequate psychological and social support during treatment; and
      6. Has the capacity to make a fully-informed decision and to consent to treatment; and
      7. Demonstrates knowledge and understanding of the expected outcomes of GnRH treatment, as well as the medical and social risks and benefits.
      B. Cross-sex hormone treatment (testosterone or estrogen) in adolescents are eligible for if they:
        1. Fulfill the criteria for GnRH treatment, and
        2. Are 16 years or older.

    IV. Coverage for GnRH and/or hormone therapy for adults (18 years and older) is considered medical necessary for:
      A. Use in Gender Dysphoria in Adults (18 years old), when ALL of the following criteria are met:
        1. Fulfills DSM V or ICD-10 criteria for gender dysphoria; and
        2. Does not suffer from psychiatric comorbidity that interferes with the diagnostic work-up or treatment or mental health comorbidities must be reasonably well-controlled; and
        3. Has adequate psychological and social support during treatment; and
        4. Has the capacity to make a fully-informed decision and to consent to treatment; and  
        5. Demonstrate knowledge and understanding of the expected outcomes of hormone treatment, as well as the medical and social risks and benefits; and
        6. Have experienced a documented real life experience of at least 3-month duration OR had a period of psychotherapy (duration specified by the Mental Health Professional after the initial evaluation, usually a minimum of 3 months); and
        7. Has made some progress in mastering other identified problems leading to improvement or continuing stable mental health; and
        8. Is likely to take hormones in a responsible manner.
    [INFORMATIONAL NOTE: Based on the World Professional Association for Transgender Health (WPATH), the following is recommended:

    Hormonal regimen for male to female patients:
    A combination of estrogen and anti-androgens is the most commonly studied regimen for feminization. They minimize the dosage of estrogen needed to suppress testosterone, thereby reducing the risks associated with high-dose exogenous estrogen. Common anti-androgens include the following: Spironolactone, GnRH (goserelin and triptorelin), and 5-alpha reductase inhibitors (finasteride and dutasteride).

    Hormone regimens for female to male patients:
    Testosterone is available in a number of injected and topical preparations, which have been designed for use in non-transgender men with low androgen levels. Since the label dosing for these medications are based on the treatment of men with low, but not no, testosterone, higher dosing may be needed in transgender person than are commonly used in non-transgender men.

    DSM 5 Criteria for Gender Dysphoria in Adults and Adolescents:

    A. A marked incongruence between one’s experienced/expressed gender and assigned gender, of at least 6 months duration, as manifested by two or more of the following indicators:
      1. a marked incongruence between one’s experienced/expressed gender and primary and/or secondary sex characteristics (or, in young adolescents, the anticipated secondary sex characteristics)
      2. a strong desire to be rid of one’s primary and/or secondary sex characteristics because of a marked incongruence with one’s experienced/expressed gender (or, in young adolescents, a desire to prevent the development of the anticipated secondary sex characteristics)
      3. a strong desire for the primary and/or secondary sex characteristics of the other gender
      4. a strong desire to be of the other gender (or some alternative gender different from one’s assigned gender)
      5. a strong desire to be treated as the other gender (or some alternative gender different from one’s assigned gender)
      6. a strong conviction that one has the typical feelings and reactions of the other gender (or some alternative gender different from one’s assigned gender)
    Format and content of referral letters for surgery from Qualified Health Professionals: (From WPATH Standards of Care, 7th Version)
      1. The client's general identifying characteristics; and
      2. Results of the client's psychosocial assessment, including any diagnoses; and
      3. The duration of the mental health professional's relationship with the client, including the type of evaluation and therapy or counseling to date; and
      4. An explanation that the criteria for surgery have been met, and a brief description of the clinical rationale for supporting the patient's request for surgery; and
      5. A statement about the fact that informed consent has been obtained from the patient; and
      6. A statement that the mental health professional is available for coordination of care and welcomes a phone call to establish this.

      Note:
      One referral from a qualified mental health professional is needed for breast surgery (e.g., mastectomy).
      Two referrals – from qualified mental health professionals who have independently assessed the patient – are needed for genital surgery (i.e., hysterectomy/salpingo-oophorectomy, orchiectomy, genital reconstructive surgeries). If the first referral is from the patient’s psychotherapist, the second referral should be from a person who has only had an evaluative role with the patient. Two separate letters, or one letter signed by both (e.g., if practicing within the same clinic) may be sent. Each referral letter, however, is expected to cover the same topics in the areas outlined above.
      Characteristics of a Qualified Mental Health Professional: (From WPATH Standards of Care, 7th Version)
        1. A master’s degree or its equivalent in a clinical behavioral science field. This degree or a more advanced one should be granted by an institution accredited by the appropriate national or regional accrediting board. The mental health professional should also have documented credentials from the relevant licensing board or equivalent; and
        2. Competence in using the Diagnostic Statistical Manual of Mental Disorders and/or the International Classification of Diseases for diagnostic purposes; and
        3. Ability to recognize and diagnose co-existing mental health concerns and to distinguish these from gender dysphoria; and
        4. Knowledgeable about gender nonconforming identities and expressions, and the assessment and treatment of gender dysphoria.
        5. Continuing education in the assessment and treatment of gender dysphoria. This may include attending relevant professional meetings, workshops, or seminars; obtaining supervision from a mental health professional with relevant experience; or participating in research related to gender nonconformity and gender dysphoria

      Based on the American Family Physician, the following is the Tanner staging recommendations for girls and boys:
      Tanner Staging in Girls:
      Tanner StageBreastsPubic HairGrowthOther
      1Prepubertal, elevation of papilla onlyPrepubertal, villus hair onlyBasal: about 5.0 to 6.0 cm (2.0 to 2.4 in) per yearAdrenarche
      Ovarian growth
      2Breast bud appears under enlarged areola (11.2 years)Sparse growth of slightly pigmented hair along the labia (11.9 years)Accelerated: about 7.0 to 8.0 cm (2.8 to 3.2 in) per yearClitoral enlargement
      Labia pigmentation
      Uterus enlargement
      3Breast tissue grows beyond areola without contour separation (12.4 years)Hair is coarser, curled and pigmented; spreads across the pubes (12.7 years)Peak velocity: about 8.0 cm (3.2 in) per year (12.5 years)Axillary hair (13.1 years)
      Acne (13.2 years)
      4Projection of areola and papilla forms a secondary mound (13.1 years)Adult-type hair but no spread to medial thigh (13.4 years)Deceleration: < 7.0 cm (2.8 in) per yearMenarche (13.3 years)
      Regular menses (13.9 years)
      5Adult breast contour with projection of papilla only (14.5 years)Adult-type hair with spread to medial thigh but not up linea alba (14.6 years)Cessation at about 16 yearsAdult genitalia
      Blondell RD, Foster MB, Dave KC. Disorders of puberty: Table 1. Am Fam Physician. 1999;60:209-18, 223-4.

      Tanner Staging in Boys:
      Tanner StageGenitaliaPubic HairGrowthOther
      1PrepubertalTestes: < 2.5 cm (1.0 in)Prepubertal, villus hair onlyBasal: about 5.0 to 6.0 cm (2.0 to 2.4 in) per yearAdrenarche
      2Thinning and reddening of scrotum (11.9 years)Testes: 2.5 to 3.2 cm (1.0 to 1.28 in)Sparse growth of slightly pigmented hair at base of penis (12.3 years)Basal: about 5.0 to 6.0 cm (2.0 to 2.4 in) per yearDecrease in total body fat
      3Growth of penis, especially length (13.2 years)Testes: 3.3 to 4.0 cm (1.32 to 1.6 in)Thicker, curlier hair spreads to the mons pubis (13.9 years)Accelerated: about 7.0 to 8.0 cm (2.8 to 3.2 in) per yearGynecomastia (13.2 years)
      Voice break (13.5 years)
      Muscle mass increase
      4Growth of penis and glands, darkening of scrotum (14.3 years)Testes: 4.1 to 4.5 cm (1.64 to 1.8 in)Adult-type hair but no spread to medial thigh (14.7 years)Peak velocity: about 10.0 cm (4.0 in) per year (13.8 years)Axillary hair (14.0 years)
      Voice change (14.1 years)
      Acne (14.3 years)
      5Adult genitalia (15.1 years)Testes: > 4.5 cm (1.8 in)Adult-type hair with spread to medial thighs but not up linea alba (15.3 years)Deceleration and cessation (about 17 years)Facial hair (14.9 years)
      Muscle mass continues to increase after Stage 5
      Blondell RD, Foster MB, Dave KC. Disorders of puberty: Table 2.]

      Medicare Coverage

      There is no National Coverage Determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for this service. Therefore, Medicare Advantage Products will follow the Horizon Policy.

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      Horizon BCBSNJ Medical Policy Development Process:

      This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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      Index:
      Drug Therapy for Transgender Policy
      Transgender Policy, Drug Therapy for

      References:
      1. The World Professional Association for Transgender Health (WPATH), Standards of Care for the Health of Transsexual, and Gender Nonconforming People. Seventh Version.July 2012. Available at: http://wpath.org/Documents2/socv6.pdf (last accessed 5/2/2019)

      2. Hembree WC, Cohen-Kettenis P, et al; Endocrine Society. Endocrine treatment of transsexual persons: an Endocrine Society clinical practice guidelines. J Clin Endocrinol Metab. 2009 Sep;94(9):3132-54. Epub 2009 Jun 9. Available at: http://press.endocrine.org/doi/pdf/10.1210/jc.2009-0345

      3. American Psychiatric Association. Gender Dysphoria - explanation of replacing "disorder" with "dysphoria" in DSM 5. Available at: http://www.dsm5.org/documents/gender%20dysphoria%20fact%20sheet.pdf

      4. Center of excellence for Transgender Health. University of California, San Francisco. Overview of Feminizing Hormone Therapy. 2016. Available at: http://transhealth.ucsf.edu/trans?page=guidelines-feminizing-therapy (last accessed 06/23/2016)

      5. Center of excellence for Transgender Health. University of California, San Francisco. Overview of Masculinizing Hormone Therapy. 2016. Available at: http://transhealth.ucsf.edu/trans?page=guidelines-masculinizing-therapy (last accessed 06/23/2016)

      6. Blondell RD, Foster MB, Dave KC. Disorders of puberty: Table 1. Am Fam Physician. 1999;60:209-18, 223-4.

      7. Blondell RD, Foster MB, Dave KC. Disorders of puberty: Table 2. Am Fam Physician. 1999;60:209-18, 223-4.

      8. Byne W, Bradley SJ, Eyler AE et al. Report of the American Psychiatric Association Task Force on Treatment of Gender Identity Disorder. Arch Sex Behav. 2012 Aug;41(4):759-98.

      9. Hembree WC, Cohen-kettenis PT, Gooren L, et al. Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society* Clinical Practice Guideline. J Clin Endocrinol Metab. 2017.

      Codes:
      (The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

      CPT*

        HCPCS

        * CPT only copyright 2019 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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        Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

        The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy

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