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PURPOSE: The intent of this clinical policy is to ensure services are medically necessary.

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PURPOSE:

The intent of this clinical policy is to ensure services are medically necessary.

Please refer to the member’s benefit document for specific information. To the extent there is any inconsistency between this policy and the terms of the member’s benefit plan or certificate of coverage, the terms of the member’s benefit plan document will govern.

POLICY:

Benefits must be available for health care services. Health care services must be ordered by a provider. Health care services must be medically necessary, applicable conservative treatments must have been tried, and the most cost-effective alternative must be requested for coverage consideration.

GUIDELINES:

Medical Necessity Criteria - Must satisfy any of the following: I - V

I. Prior to initiation of puberty suppressing hormones, the following minimum criteria must be met: A - E

A. The adolescent must have reached Tanner Stage 2 or above (see Attachment A); and

B. The adolescent has demonstrated a long-lasting and intense pattern of gender nonconformity or gender dysphoria (whether suppressed or expressed); and

C. Gender dysphoria emerged or worsened with the onset of puberty; and

D. Any co-existing psychological, medical, or social problems that could interfere with treatment (eg, that may compromise treatment adherence) have been addressed, such that the adolescent’s situation and functioning are stable enough to start treatment; and

E. The adolescent has given informed consent and, particularly when the adolescent has not reached the age of medical consent, the parents or other caretakers or guardians have consented to the treatment and are involved in supporting the adolescent throughout the treatment process.

II. Prior to initiation of hormonal gender reassignment (feminization/masculinization hormone therapy), the member must have all of the following: A - E

A. If less than 18 years old, member must have reached Tanner Stage 2 or above (see Attachment A); and

[Note: Prior authorization is not required for hormonal gender reassignment if member is age 18 or older)

B. At least 1 referral letter from a qualified mental health professional to the health professional that will be providing the service. The referral letter must address all of the following: 1 - 6

1. The member’s general identifying characteristics;

2. Results of the member’s psychosocial assessment, including any diagnoses;

3. The duration of the mental health professional’s relationship with the member, including the type of evaluation and therapy or counseling administered to date;

4. An explanation that the criteria for hormone therapy have been met and a brief description of the clinical rationale for supporting the member’s request for hormone therapy;

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5. A statement about the fact that informed consent has been obtained from the member; 6. A statement that the mental health professional is available for coordination of care and

welcomes a phone call to establish this.

C. Well-documented persistent gender dysphoria; and

D. The capacity to make a fully informed decision and to give consent for treatment; and

E. Documentation that significant medical or mental health concerns, if present, are reasonably well-controlled.

III. Prior to the initiation of breast or chest gender reassignment surgery, the member must have all of the following: A - D, and E as applicable

A. At least 1 referral letter from a qualified mental health professional. The referral letter must address all of the following: 1 - 6

1. The member’s general identifying characteristics;

2. Results of the member’s psychosocial assessment, including any diagnoses;

3. The duration of the mental health professional’s relationship with the member, including the type of evaluation and therapy or counseling administered to date;

4. An explanation that the criteria for surgery have been met and a brief description of the clinical rationale for supporting the member’s request for surgery;

5. A statement about the fact that informed consent has been obtained from the member; 6. A statement that the mental health professional is available for coordination of care and

welcomes a phone call to establish this.

B. Well-documented, persistent gender dysphoria; and

C. The capacity to make a fully informed decision and to give consent for treatment; and

D. Documentation that significant medical or mental health concerns, if present, are reasonably well-controlled.

E. Request for female-to-male (FtM) in members less than 18 years of age – must have received at least 1 year of testosterone treatment.

IV. Prior to initiation of hysterectomy and salpingo-oophorectomy in FtM gender reassignment surgery and orchiectomy in male-to-female (MtF) gender reassignment surgery, the member must have all of the following: A - F

A. The member must be at least 18 years of age; and

B. At least 2 referral letters from qualified mental health professionals. If the first referral is from the member’s psychotherapist, the second referral should be from a qualified mental health

professional that has only had an evaluative role with the member. Two separate letters, or one letter signed by both (if practicing within the same clinic) may be sent. Each referral letter must address all of the following: 1 - 6

1. The member’s general identifying characteristics;

2. Results of the member’s psychosocial assessment, including any diagnoses;

3. The duration of the mental health professional’s relationship with the member, including the type of evaluation and therapy or counseling administered to date;

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4. An explanation that the criteria for surgery have been met and a brief description of the clinical rationale for supporting the member’s request for surgery;

5. A statement about the fact that informed consent has been obtained from the member; 6. A statement that the mental health professional is available for coordination of care and

welcomes a phone call to establish this. C. Well-documented persistent gender dysphoria; and

D. The capacity to make a fully informed decision and to give consent for treatment; and

E. At least 12 continuous months of hormone therapy as appropriate to the member’s gender goals (unless hormones are not clinically indicated); and

F. Documentation that significant medical or mental health concerns, if present, are reasonably well-controlled.

V. Prior to initiation of metoidioplasty or phalloplasty in FtM gender reassignment surgery and

vaginoplasty in MtF gender reassignment surgery, the member must have all of the following: A - G

A. The member must be at least 18 years of age; and

B. At least 2 referral letters from qualified mental health professionals. If the first referral is from the member’s psychotherapist, the second referral should be from a qualified mental health

professional who has only had an evaluative role with the member. Two separate letters, or one letter signed by both (ie, if practicing within the same clinic) may be sent. Each referral letter must address all of the following: 1 - 6

1. The member’s general identifying characteristics;

2. Results of the member’s psychosocial assessment, including any diagnoses;

3. The duration of the mental health professional’s relationship with the member, including the type of evaluation and therapy or counseling administered to date;

4. An explanation that the criteria for surgery have been met and a brief description of the clinical rationale for supporting the member’s request for surgery;

5. A statement about the fact that informed consent has been obtained from the member; 6. A statement that the mental health professional is available for coordination of care and

welcomes a phone call to establish this.

C. Well-documented persistent gender dysphoria; and

D. The capacity to make a fully informed decision and to give consent for treatment; and

E. At least 12 continuous months of hormone therapy as appropriate to the member’s gender goals (unless hormones are not clinically indicated for the member); and

F. That if significant medical or mental health concerns are present, they are reasonably well-controlled; and

G. At least 12 continuous months of living in a gender role that is congruent with their gender identity (such as, but not limited to, consistently presenting in the member’s desired gender role on a day-to-day basis and across all settings of life; coming out to partners, family, friends, and community members; and acquiring legal name and/or gender marker change).

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EXCLUSIONS (not limited to):

Refer to member’s Certificate of Coverage or Summary Plan Description.

DEFINITIONS:

Gender dysphoria or gender identity disorder

Is defined as evidence of a strong and persistent cross-gender identification, which is the desire to be, or the insistence that one is of the other gender. Persons with this disorder experience a sense of discomfort and inappropriateness regarding their anatomic or genetic sexual characteristics.

Gender reassignment

Refers to the hormonal and surgical reassignment of gender dysphoric persons.

Gender reassignment surgery

May involve any of a number of procedures including, but not limited to: mastectomy, reduction mammoplasty, castration, orchidectomy, penectomy, vaginoplasty, hysterectomy, salpingectomy, vaginectomy, oophorectomy, and phalloplasty.

Gonadotropin releasing hormone (GnRH) analogues (agonists and antagonists)

Synthetic drugs similar to natural GnRH. There are two main types: agonists and antagonists. • Agonists stimulate the pituitary gland to secrete follicle stimulating hormone (FSH), luteinizing

hormone (LH) secretion. Unlike natural GnRH, which is secreted in a pulsatile manner, synthetic agonists have a constant pharmacokinetic action. They are usually administered via nasal spray or via injection

• Antagonists also suppress FSH and LH production, but unlike agonists, they do so without the initial stimulation. Antagonists are usually injected.

Hormonal gender reassignment

Refers to the administration of androgens (male hormones) to genetic females and estrogens and/or progesterones (female hormones) to genetic males for the purpose of effecting somatic changes

(softening of skin, hair growth, breast development etc.) in order to more closely approximate the physical appearance of the other gender.

Puberty suppression

Refers to the administration of GnRH analogues to suppress estrogen or testosterone production and consequently delay the physical changes of puberty.

• Adolescents with male genitalia should be treated with GnRH analogues, which stop luteinizing hormone secretion and therefore testosterone secretion. Alternatively, they may be treated with progestins (such as medroxyprogesterone) or other medications (such as spironolactone) that block testosterone secretion and/or neutralize testosterone action.

• Adolescents with female genitalia should be treated with GnRH analogues, which stop the production of estrogens and progesterone. Alternatively, they may be treated with progestins (such as medroxyprogesterone). Continuous oral contraceptives (or depot medroxyprogesterone) may be used to suppress menses.

Qualified mental health professional:

The following are the minimum credentials for mental health professionals who work with adults presenting with gender dysphoria:

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• Competence in using the Diagnostic Statistical Manual of Mental Disorders and/or the International Classification of Diseases for diagnostic purposes

• Ability to recognize and diagnose co-existing mental health concerns and to distinguish these from gender dysphoria

• Documented supervised training and competence in psychotherapy or counseling

• Knowledge about gender nonconforming identities and expressions, and the assessment and treatment of gender dysphoria

• Continuing education in assessment and treatment of gender dysphoria The following are desired credentials but are not required:

• Cultural competence to facilitate their work with transsexual, transgender, and gender

nonconforming clients, e.g. knowledgeable about community, advocacy and public policy issues relevant to these clients and their families

• Knowledge about sexuality, sexual health concerns, and the assessment and treatment of sexual disorders

BACKGROUND:

Gender dysphoria or gender identity disorder is not the same condition that occurs in patients suffering from genetic or hormonal abnormalities, or ambiguous genitalia. All gender reassignment requests require physician review.

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Prior Authorization: Yes, for hormonal reassignment (feminizing/masculinizing) for age less than 18; for surgical procedures for reassigning biological gender for all ages; and for puberty suppression hormone therapy - per network provider agreement.

CODING:

When billed with the following ICD-10 diagnosis codes: F64.0 transsexualism

F64.1 dual role transvestism

F64.2 gender identify disorder of childhood F64.8 other gender identity disorders F64.9 gender identify disorder, unspecified

Z87.890 personal history of sex reassignment status

J1071 Injection, testosterone cypionate, 1 mg J1380 Injection, estradiol valerate, up to 10 mg J1410 Injection, estrogens, conjugated, per 25 mg J1675 injection, histrelin acetate, 10mcg

J1950 Injection, leuprolide acetate (for depot suspension), per 3.75 mg J3121 Injection, testosterone enanthate, 1 mg

J3145 Injection, testosterone undecanoate, 1 mg J3315 Triptorelin pamoate 22.5mg (Triptodur) GnRH J9155 Degarelix acetate 1mg (Firmagon) GnRH J9202 Goserelin acetate implant, per 3.6 mg

J9217 Leuprolide acetate (for depot suspension), 7.5 mg J9218 Leuprolide acetate, per 1 mg

J9219 Leuprolide acetate implant, 65 mg J9225 Histrelin implant (Vantas), 50mg J9226 Histrelin implant (Supprelin LA), 50mg S0189 Testosterone pellet, 75 mg

CPT®

19303 Mastectomy, simple, complete 19318 Reduction mammaplasty

53430 Urethroplasty, reconstruction of female urethra 54125 Amputation of penis; complete

54400 Insertion of penile prosthesis; non-inflatable 54401 Insertion of penile prosthesis; inflatable

54405 Insertion of multi-component, inflatable penile prosthesis, including placement of pump, cylinders, and reservoir

54408 Repair of components of a multi-component, inflatable penile prosthesis

54410 Removal and replacement of all components of a multi-component, inflatable penile prosthesis at the same operative session

54411 Removal and replacement of all components of a multi-component inflatable penile prosthesis through an infected field at the same operative session, including irrigation and debridement of the infected tissue

54416 Removal and replacement of non-inflatable (semi-rigid) or inflatable (self-contained) penile prosthesis at the same operative session

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54417 Removal and replacement of all components of a non-inflatable (semi-rigid) or inflatable (self-contained)penile prosthesis through an infected field at the same operative session, including irrigation and debridement of the infected tissue

54520 Orchiectomy, simple (including subcapsular), with or without testicular prosthesis, scrotal or inguinal approach

54660 Insertion of testicular prosthesis (separate procedure) 54690 Laparoscopic, surgical; orchiectomy

55175 Scrotoplasty; simple 55180 Scrotoplasty; complicated

55970 Intersex surgery; male to female (a series of staged procedures that includes male genitalia removal, penile dissection, urethral transposition, creation of vagina and labia with stent placement) 55980 Intersex surgery; female to male (a series of stated procedures that includes penis and scrotum formation by graft, and prosthesis placement)

56625 Vulvectomy simple; complete 56800 Plastic repair of introitus 56805 Clitoroplasty for intersex state

56810 Perineoplasty, repair of perineum, nonobstetrical (separate procedure) 57106 Vaginectomy, partial removal of vaginal wall

57107 Vaginectomy, partial removal of vaginal wall; with removal of paravaginal tissue 57110 Vaginectomy, complete removal of vaginal wall

57111 Vaginectomy, complete removal of vaginal wall; with removal of paravaginal tissue (radial vaginectomy)

57291 Construction of artificial vagina; without graft 57292 Construction of artificial vagina; with graft 57335 Vaginoplasty for intersex state

58180 Supracervical abdominal hysterectomy (subtotal) hysterectomy), with or without removal of tubes, with or without removal of ovary(s)

58260 Vaginal hysterectomy, for uterus 250g or less

58262 Vaginal hysterectomy, for uterus 250g or less; with removal of tubes, and or ovary(s) 58263 Vaginal hysterectomy, for uterus 250g or less; with removal of tubes, and or ovary 58275 Vaginal hysterectomy, with total or partial vaginectomy

58290 Vaginal hysterectomy, for uterus greater than 250g

58291 Vaginal hysterectomy, for uterus greater than 250g; with removal of tube(s) and/or ovary(s) 58541 Laparoscopy, surgical, supracervical hysterectomy, for uterus 250g or less\

58542 Laparoscopy, surgical, supracervical hysterectomy, for uterus 250g or less; with removal of tube(s) and/or ovary(s)

58543 Laparoscopy, surgical, supracervical hysterectomy, for uterus greater than 250g

58544 Laparoscopy, surgical, supracervical hysterectomy, for uterus greater than 250g; with removal of tube(s) and/or ovary(s)

58550 Laparoscopy, surgical, with vaginal hysterectomy, for uterus 250g or less

58552 Laparoscopy, surgical, with vaginal hysterectomy, for uterus 250g or less; with removal of tube(s) and/or ovary(s)

58553 Laparoscopy, surgical, with vaginal hysterectomy, for uterus greater than 250g

58554 Laparoscopy, surgical, with vaginal hysterectomy, for uterus greater than 250g; with removal of tube(s) and/or ovary(s)

58570 Laparoscopy, surgical, with total hysterectomy, for uterus 250g or less

58571 Laparoscopy, surgical, with total hysterectomy, for uterus 250g or less; with removal of tube(s) and/or ovary(s)

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58573 Laparoscopy, surgical, with total hysterectomy, for uterus greater than 250g; with removal of tube(s) and/or ovary(s)

58661 Laparoscopy, surgical; with removal of adnexal structures (partial or totally oophorectomy and/or salpingectomy)

CPT codes copyright 2020 American Medical Association. All Rights Reserved. CPT is a trademark of the AMA. The AMA assumes no liability for the data contained herein.

REFERENCES:

1. Integrated Healthcare Services Process Manual: UR015 Use of Medical Policy and Criteria 2. Clinical Policy: MP/C009 Coverage Determination Guidelines

3. Clinical Policy: MP/C002 Cosmetic Treatments 4. Minnesota Statute 363A.17 Business Discrimination

5. Minnesota Department of Commerce Administrative Bulletin 2015-5 Gender Identity

Nondiscrimination Requirements. November 24, 2015. Retrieved from http://mn.gov/commerce-stat/pdfs/bulletin-insurance-2015-5.pdf.

6. World Professional Association for Transgender Health. Standards of care for the health of transsexual, transgender, and gender nonconforming people. 7th Version. 2012. Retrieved from https://www.wpath.org/publications/soc. Accessed 04-24-20.

7. Rafferty, J., AAP Committee on Psychosocial Aspects of Child and Family Health, Committee on Adolescences, Section on Lesbian, Gay, Bisexual, and Transgender Health and Wellness. Ensuring Comprehensive Care and Support for Transgender and Gender-Diverse Children and Adolescents. Pediatrics. 2018;142(4):e20182162.

8. Hembree WC, Cohen-Kettenis P, et al, Endocrine Society. Endocrine treatment of transsexual persons; an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2009 Sep;94 (9);3132-54 [157 references] PubMed

9. Biro FM. Normal puberty. (Topic 5849, Version 34.0; last updated: 12/31/19) In: Hoppin AG, ed. UpToDate. Waltham, Mass.: UpToDate; 2018. www.uptodate.com. Accessed 04-24-20.

10. Mahfouda BA, Moore JK, Franz CP, et al. Puberty Suppression in Transgender Children and Adolescents. The Lancet Diabetes Endocrinol 2017;5816-26.

DOCUMENT HISTORY:

Created Date: (Previously MP/G002) 04/22/20 Reviewed Date:

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Attachment A – Sexual maturity rating (Tanner stages) of secondary sexual characteristics

Boys - Development of external genitalia Stage 1: Prepubertal

Stage 2: Enlargement of scrotum and testes; scrotal skin reddens and changes in texture

Stage 3: Enlargement of penis (length at first); further growth of testes

Stage 4: Increased size of penis with growth in breadth and development of glans; testes and scrotum larger, scrotal skin darker

Stage 5: Adult genitalia

Girls - Breast development Stage 1: Prepubertal

Stage 2: Breast bud stage with elevation of breast and papilla; enlargement of areola

Stage 3: Further enlargement of breast and areola; no separation of their contour

Stage 4: Areola and papilla form a secondary mound above level of breast

Stage 5: Mature stage: projection of papilla only, related to recession of areola

Boys and girls - Pubic hair

Stage 1: Prepubertal (the pubic area may have vellus hair, similar to that of forearms)

Stage 2: Sparse growth of long, slightly pigmented hair, straight or curled, at base of penis or along labia

Stage 3: Darker, coarser and more curled hair, spreading sparsely over junction of pubes

Stage 4: Hair adult in type, but covering smaller area than in adult; no spread to medial surface of thighs

Stage 5: Adult female in type and quantity, with horizontal upper border

Retrieved from: Biro FM. Normal puberty. (Graphic 55329, Version 10.0) In: Hoppin AG, ed. UpToDate. Waltham, Mass.: UpToDate; 2018. www.uptodate.com. Accessed 12-10-19.

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• Written information in other formats (large print, audio, accessible electronic formats, other formats) Provides free language services to people whose primary language is not English, such as:

• Qualified interpreters

• Information written in other languages

If you need these services, contact a Grievance Specialist.

If you believe that PCHP has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with:

Grievance Specialist

PreferredOne Community Health Plan PO Box 59052

Minneapolis, MN 55459-0052

Phone: 1.800.940.5049 (TTY: 763.847.4013) Fax: 763.847.4010

customerservice@preferredone.com

You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, a Grievance Specialist is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services 200 Independence Avenue, SW

Room 509F, HHH Building Washington, D.C. 20201

1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

Language Assistance Services

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• Written information in other formats (large print, audio, accessible electronic formats, other formats) Provides free language services to people whose primary language is not English, such as:

• Qualified interpreters

• Information written in other languages

If you need these services, contact a Grievance Specialist.

If you believe that PIC has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with:

Grievance Specialist

PreferredOne Insurance Company PO Box 59212

Minneapolis, MN 55459-0212

Phone: 1.800.940.5049 (TTY: 763.847.4013) Fax: 763.847.4010

customerservice@preferredone.com

You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, a Grievance Specialist is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services 200 Independence Avenue, SW

Room 509F, HHH Building Washington, D.C. 20201

1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

Language Assistance Services

References

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