WSR 21-01-012
PROPOSED RULES
HEALTH CARE AUTHORITY
[Filed December 3, 2020, 9:49 a.m.]
Original Notice.
Preproposal statement of inquiry was filed as WSR 19-24-054.
Title of Rule and Other Identifying Information: WAC 182-531-1675 Washington apple healthGender affirming interventions for gender dysphoria.
Hearing Location(s): On January 26, 2021, at 10:00 a.m. In response to the coronavirus disease 2019 (COVID-19) public health emergency, the agency will not provide a physical location for this hearing. This promotes social distancing and the safety of the citizens of Washington state. A virtual public hearing, without a physical meeting space, will be held instead. To attend the virtual public hearing, you must register at the following link https://attendee.gotowebinar.com/register/5895859935949871883. Webinar ID: 563-710-843. After registering, you will receive a confirmation email containing the information about joining the webinar.
Date of Intended Adoption: Not sooner than January 27, 2021.
Submit Written Comments to: Health Care Authority (HCA), Rules Coordinator, P.O. Box 42716, Olympia, WA 98504-2716, email arc@hca.wa.gov, fax 360-586-9727, by January 26, 2021.
Assistance for Persons with Disabilities: Contact Amber Lougheed, phone 360-725-1349, fax 360-586-9727, telecommunication[s] relay service 711, email amber.lougheed@hca.wa.gov, by January 8, 2021.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The agency is revising this rule to:
Remove the list of noncovered services and clarify that requests will be evaluated for medical necessity;
Remove barriers and unnecessary administrative processes for the client and provider; and
Streamline the authorization process.
The proposed rule:
Provides that psychosocial evaluations shall be effective for eighteen months instead of twelve;
Allows clients to document safety concerns that have prevented them from living full time in the desired gender; and
Includes alternate requirements for clients who have not met the standard documentation requirements for surgery.
Reasons Supporting Proposal: See purpose.
Statutory Authority for Adoption: RCW 41.05.021, 41.05.160.
Statute Being Implemented: RCW 41.05.021, 41.05.160.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: HCA, governmental.
Name of Agency Personnel Responsible for Drafting: Melinda Froud, P.O. Box 42716, Olympia, WA 98504-2716, 360-725-1408; Implementation and Enforcement: Annette Schuffenhauer, P.O. Box 45502, Olympia, WA 98504-5502, 360-725-1254.
A school district fiscal impact statement is not required under RCW 28A.305.135.
A cost-benefit analysis is not required under RCW 34.05.328. RCW 34.05.328 does not apply to HCA rules unless requested by the joint administrative rules review committee or applied voluntarily.
The proposed rule does not impose more-than-minor costs on businesses. Following is a summary of the agency's analysis showing how costs were calculated. These rules do not impose costs on businesses.
December 3, 2020
Wendy Barcus
Rules Coordinator
OTS-2460.2
AMENDATORY SECTION(Amending WSR 15-16-084, filed 7/31/15, effective 8/31/15)
WAC 182-531-1675Washington apple healthGender affirming interventions for gender dysphoria ((treatment program)).
(1) Overview of ((the gender dysphoria)) treatment program.
(a) Medicaid agency coverage. The medicaid agency covers the ((following services, consistent with the program rules described in Title 182 WAC, to treat gender dysphoria:
(i)))services listed in (b) of this subsection to treat gender dysphoria (also referred to as gender incongruence) under WAC 182-501-0050 and 182-531-0100. These services include life-changing procedures that may not be reversible.
(b) Medical services covered. Medical services ((including, but))covered by the agency include, but are not limited to:
(((A)))(i) Presurgical and postsurgical hormone therapy;
(((B) Prepuberty))(ii) Puberty suppression therapy;
(((ii) Mental))(iii) Behavioral health services; and
(((iii)))(iv) Surgical and ancillary services including, but not limited to:
(A) Anesthesia;
(B) Labs;
(C) Pathology;
(D) Radiology;
(E) Hospitalization;
(F) Physician services; and
(G) Hospitalizations and physician services required to treat postoperative complications of procedures performed under ((component four.
(b) The agency's gender dysphoria treatment program has four components. Prior authorization is required for services provided in component four only. Any medicaid provider can refer a client to component one. These components are not intended to be sequential and may run concurrently to meet the client's medical needs. The components are as follows:
(i) Component one - Initial assessment and diagnosis of gender dysphoria;
(ii) Component two - Mental health and medical treatment;
(iii) Component three - Presurgical requirements for prior authorization for component four; and
(iv) Component four - Gender reassignment surgery.
(c) All services under this program must be delivered by providers who meet the qualifications in subsection (2) of this section.
(d) The agency evaluates requests for clients under age twenty-one according to the early and periodic screening, diagnosis, and treatment (EPSDT) program described in chapter 182-534 WAC. Under the EPSDT program, a service may be covered if it is medically necessary, safe, effective, and not experimental.
(e) The agency covers transportation services under the provisions of chapter 182-546 WAC.
(f) Any out-of-state care, including a presurgical consultation, must be approved as an out-of-state service under WAC 182-501-0182.
(2) Qualified health care providers for gender dysphoria treatment.
(a) Providers must meet the qualifications outlined in chapter 182-502 WAC.
(b) Each provider must be recognized as an agency-designated center of excellence (COE). COE is defined in WAC 182-531-0050. To be a COE, all providers must complete an agency form attesting that they:
(i) Possess knowledge about current community, advocacy, and public policy issues relevant to transgender people and their families (knowledge about sexuality, sexual health concerns, and the assessment and treatment of sexual disorders is preferred);
(ii) Endorse the Standards of Care for the Health of Transsexual, Transgender, and Gender-Nonconforming People, Version 7 as developed by the World Professional Association for Transgender Health (WPATH); and
(iii) Agree to provide services consistent with this section. The agency's forms are available online at http://www.hca.wa.gov/medicaid/forms/Pages/index.aspx.
(c) Diagnosis in component one must be made or confirmed by a COE provider who is a board certified physician, a psychologist, a board certified psychiatrist, or a licensed advanced registered nurse practitioner (ARNP).
(d) Mental health professionals who provide component two mental health treatment described in subsection (4)(d) of this section, or who perform the psychosocial evaluation described in subsection (5)(a)(iii) of this section must:
(i) Meet the requirements described in WAC 182-531-1400;
(ii) Sign the agency's form (HCA 18-493) attesting that they:
(A) Are competent in using the Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and the International Classification of Diseases for diagnostic purposes;
(B) Are able to recognize and diagnose coexisting mental health conditions and to distinguish these from gender dysphoria;
(C) Have completed supervised training in psychotherapy or counseling;
(D) Are knowledgeable of gender-nonconforming identities and expressions, and the assessment and treatment of gender dysphoria; and
(E) Have completed 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; and
(iii) Be a board certified psychiatrist, a psychologist, or a licensed:
(A) Psychiatric ARNP;
(B) Psychiatric mental health nurse practitioner;
(C) Mental health counselor;
(D) Independent clinical social worker;
(E) Advanced social worker; or
(F) Marriage and family therapist.
(e) Any surgeon who performs gender reassignment surgery must:
(i) Be a board certified or board qualified:
(A) Urologist;
(B) Gynecologist;
(C) Plastic surgeon;
(D) Cosmetic surgeon; or
(E) General surgeon;
(ii) Have a valid medical license in the state where the surgery is performed; and
(iii) Sign the agency's form (HCA 18-492) attesting to specialized abilities in genital reconstructive techniques and produce documentation showing that they have received supervised training with a more experienced surgeon.
(f) Any medical provider managing hormone therapy, androgen suppression, or puberty suppression for clients diagnosed with gender dysphoria must:
(i) Be either of the following:
(A) A licensed, board certified, or board qualified:
(I) Endocrinologist;
(II) Family practitioner;
(III) Internist;
(IV) Obstetrician/gynecologist;
(V) Pediatrician;
(VI) Naturopath; or
(B) A licensed ARNP or a licensed physician's assistant; and
(ii) Sign the agency's form (HCA 18-494) attesting to specialized abilities managing hormone therapy in treating gender dysphoria. The specialized abilities may be proved by producing documentation showing supervised training with a more experienced physician, and attesting attendance at relevant professional meetings, workshops, or seminars.
(3) Component one – Initial assessment and diagnosis of gender dysphoria. The purpose of component one is to assess and diagnose the client, and refer the client to other qualified providers as needed for additional medically necessary services. A health professional who meets the qualifications in subsection (2)(c) of this section must assess the client and:
(a) Confirm the diagnosis of gender dysphoria as defined by the Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
(b) Determine the gender dysphoria is not the result of another mental or physical health condition, and refer the client to other specialists if other health conditions are indicated;
(c) Develop an individualized treatment plan for the client;
(d) Refer the client to qualified providers for the component two services described in subsection (4) of this section; and
(e) Assist and support the client in navigating component two and component three requirements, and provide services consistent with WPATH guidelines and WAC 182-531-1675.
(4) Component two – Mental health and medical treatment.
(a) Clients enrolled with an agency managed care organization (MCO) plan are subject to the respective plan's policies and procedures for coverage of these services.
(b) Mental health and medical treatment are covered after a health professional who meets the qualifications in subsection (2)(c) of this section has diagnosed, or confirmed the diagnosis of, gender dysphoria as defined by the DSM-5 criteria.
(c) Medical treatment in component two covers androgen suppression, puberty suppression, continuous hormone therapy, and laboratory testing to monitor the safety of hormone therapy. Some of these prescriptions may be subject to prior authorization as required by pharmacy policy in chapter 182-530 WAC. Medical treatment must be prescribed by a COE provider who meets the requirements in subsection (2)(a), (b), and (f) of this section.
(d) The agency covers mental health treatment for the client and the client's spouse, parent, guardian, child, or person with whom the client has a child in common if the treatment is:
(i) Medically necessary;
(ii) Provided according to the provisions of WAC 182-531-1400; and
(iii) Provided by a health professional who meets the requirements in subsection (2)(a), (b), and (d) of this section.
(5) Component three – Presurgical requirements.
(a) To proceed to component four gender reassignment surgery, the client must:
(i) Be age eighteen or older, unless allowed under EPSDT as described in subsection (1)(d) of this section;
(ii) Be competent to give consent for treatment and have this competency documented in clinical records; and
(iii) Undergo a comprehensive psychosocial evaluation that must do all of the following:
(A) Be conducted by two mental health professionals for genital surgery and one mental health professional for chest surgery. These mental health professionals must meet the qualifications described in subsection (2)(d) of this section.
(B) Confirm the diagnosis of gender dysphoria, document that professionals performing the evaluation believe the client is a good candidate for gender reassignment surgery, and document that surgery is the next reasonable step in the client's care.
(C) Evaluate the client for the presence of coexisting behavioral health conditions (substance abuse problems, or mental health illnesses), which could prevent the client from participating in gender dysphoria treatment including, but not limited to, gender reassignment surgery and postsurgical care.
(D) Document that any coexisting behavioral health condition is adequately managed.
(b) The surgeon who will perform the gender reassignment surgery and who meets the qualifications outlined in subsection (2)(a), (b), and (e) of this section, must complete a presurgical consultation. When the presurgical consultation is completed, the surgeon must forward the report of the consultation to the other treatment team members.
(c) The client must have received continuous hormone therapy as required by the treatment plan to meet treatment objectives. For exceptions, see subsection (6)(b) of this section.
(d) The client must have lived in a gender role congruent with the client's gender identity immediately preceding surgery as required by the treatment plan to meet treatment objectives. For exceptions, see subsection (6)(b) of this section.
(e) The client's medical record must document that the client met the requirements in (a) through (d) of this subsection.
(f) A member of the treatment team must write a referral letter and submit it to the agency along with the prior authorization request for surgery. The contents of the referral letter or its attachments must include:
(i) Results of the client's psychosocial evaluation, as described in (a)(iii) of this subsection;
(ii) Documentation that any coexisting behavioral health condition is adequately managed;
(iii) A description of the relationship between the mental health professionals and the client, including the duration of the professional relationship, and the type of evaluation and therapy or counseling to date;
(iv) A brief description of the clinical justification supporting the client's request for surgery;
(v) An assessment and attestation that the provider believes the client is able to comply with the postoperative requirements, has the capacity to maintain lifelong changes, and will comply with regular follow up;
(vi) A statement about the client's adherence to the medical and mental health treatment plan;
(vii) A description of the outcome of the client's hormone therapy;
(viii) A copy of the client's signed informed consent according to the requirements under WAC 182-531-1550, or written acknowledgment of the permanent impact on male and female reproductive capacity if WAC 182-531-1550 is not applicable;
(ix) A statement that all the members of the treatment team will be available to coordinate or provide postoperative care as needed;
(x) A description of the surgical plan. See subsection (6)(d) and (e) of this section, covered and noncovered procedures. The description must:
(A) List all planned surgical procedures, including any listed in subsection (6)(e) of this section, with clinical justification; and
(B) Provide a timeline of surgical stages if clinically indicated; and
(xi) Signatures from the following treatment team members:
(A) The two mental health professionals for genital surgery and one mental health professional for chest surgery who completed the responsibilities described in subsection (4)(d) of this section and (a)(iii) of this subsection;
(B) The medical provider who has managed the care;
(C) Any surgeon performing the procedures; and
(D) The client.
(6) Component four – Gender reassignment surgery.
(a) The agency requires prior authorization for component four. Subsection (5) of this section lists the documentation that is required to be submitted with the authorization requests. Surgeries are not required to be completed at the same time. Surgeries may be performed in progressive stages.
(b) If the client fails to complete all of the requirements in subsection (5) of this section, the agency will not authorize gender reassignment surgery unless the clinical decision-making process is provided in the referral letter and attachments described in subsection (5)(f) of this section.
(c) A client preparing for gender reassignment surgery must be cared for by a treatment team consisting of:
(i) One of the mental health professionals described in subsection (2)(d) of this section, if mental health services are part of the treatment plan;
(ii) The medical provider who managed the medical care in component two and component three; and
(iii) Any surgeon performing the procedures.
(d) The agency covers the following procedures in component four with prior authorization:
(i) Abdominoplasty;
(ii) Belpharoplasty;
(iii) Breast reconstruction (male to female);
(iv) Bilateral mastectomy with or without chest reconstruction;
(v) Cliteroplasty;
(vi) Colovaginoplasty;
(vii) Colpectomy;
(viii) Genital surgery;
(ix) Genital electrolysis as required as part of the genital surgery;
(x) Hysterectomy;
(xi) Labiaplasty;
(xii) Laryngoplasty;
(xiii) Metoidioplasty;
(xiv) Orchiectomy;
(xv) Penectomy;
(xvi) Phalloplasty;
(xvii) Placement of testicular prosthesis;
(xviii) Rhinoplasty;
(xix) Salpingo-oophorectomy;
(xx) Scrotoplasty;
(xxi) Urethroplasty;
(xxii) Vaginectomy; and
(xxiii) Vaginoplasty.
(e) For the purposes of this section, the agency will review on a case-by-case basis and may pay for the following noncovered services under exception to rule:
(i) Cosmetic procedures and services:
(A) Brow lift;
(B) Calf implants;
(C) Cheek/malar implants;
(D) Chin/nose implants;
(E) Collagen injections;
(F) Drugs for hair loss or growth;
(G) Facial or trunk electrolysis, except for the limited electrolysis described in (d)(ix) of this subsection;
(H) Facial feminization;
(I) Face lift;
(J) Forehead lift;
(K) Hair transplantation;
(L) Jaw shortening;
(M) Lip reduction;
(N) Liposuction;
(O) Mastopexy;
(P) Neck tightening;
(Q) Pectoral implants;
(R) Reduction thyroid chondroplasty;
(S) Removal of redundant skin;
(T) Suction-assisted lipoplasty of the waist; and
(U) Trachea shave;
(ii) Voice modification surgery; and
(iii) Voice therapy.
(f) The agency evaluates a request for any noncovered service listed in (e) of this subsection as an exception to rule under the provisions of WAC 182-501-0160. The justification included in the surgical plan for any of the procedures listed in (e) of this subsection may be recognized by the agency as meeting the documentation requirements of WAC 182-501-0160.))this section.
(c) Surgical services covered. Surgical services to treat gender dysphoria are a covered service with prior authorization for clients who have a diagnosis of gender dysphoria made by a provider who meets the qualifications outlined in chapter 182-502 WAC.
(d) Medical necessity. Under this program, the agency authorizes and pays for only medically necessary services. Medical necessity is defined in WAC 182-500-0070 and is determined under WAC 182-501-0165 and limitation extensions in accordance with WAC 182-501-0169.
(e) Provider requirements. Providers should be knowledgeable of gender-nonconforming identities and expressions, and the assessment and treatment of gender dysphoria, including experience utilizing standards of care that include the World Professional Association for Transgender Health (WPATH) Standards of Care.
(f) Clients age twenty and younger. The agency evaluates requests for clients age twenty and younger according to the early and periodic screening, diagnosis, and treatment (EPSDT) program described in chapter 182-543 WAC. Under the EPSDT program, the agency pays for a service if it is medically necessary, safe, effective, and not experimental.
(g) Transportation services. The agency covers transportation services under the provisions of chapter 182-546 WAC.
(h) Out-of-state care. Any out-of-state care, including a presurgical consultation, must be prior authorized as an out-of-state service under WAC 182-501-0182.
(i) Reversal procedures. The agency does not cover procedures and surgeries related to reversal of gender affirming surgery.
(2) Prior authorization.
(a) Prior authorization requirements for surgical services. The agency requires prior authorization for all surgical services to treat gender dysphoria, including modifications to, or complications from, a previous surgery, except as provided in subsection (3) of this section.
(b) Required documentation. The following documentation must be submitted with the prior authorization request:
(i) Two psychosocial evaluations required. Documentation of two separate psychosocial evaluations performed within eighteen months preceding surgery by two separate qualified mental health professionals as defined in WAC 182-531-1400. These providers must be licensed health care professionals who are eligible under chapter 182-502 WAC, as follows:
(A) Psychiatrist;
(B) Psychologist;
(C) Psychiatric advanced registered nurse practitioner (ARNP);
(D) Psychiatric mental health nurse practitioner-board certified (PMHNP-BC);
(E) Mental health counselor (LMHC);
(F) Independent clinical social worker (LICSW);
(G) Advanced social worker (LASW); or
(H) Marriage and family therapist (LMFT).
(ii) One psychosocial evaluation for top surgery. For top surgery with or without chest reconstruction, the agency requires only one comprehensive psychosocial evaluation.
(iii) Evaluation requirements. Each comprehensive psychosocial evaluation must:
(A) Confirm the diagnosis of gender dysphoria as defined by the Diagnostic Statistical Manual of Mental Disorders;
(B) Establish that the client's condition is associated with clinically significant distress or impairment in social, occupational, or other important areas of functioning due to a strong desire to be rid of one's birth sex characteristics because of a marked incongruence with one's experiences or expressed gender, or both; and
(C) Document that:
(I) The client has:
• Lived in the desired gender full time, in all aspects of life, for a minimum of one year immediately preceding the request; or
• Been unable to live in the desired gender in all aspects of life full time due to personal safety concerns. Documentation must include an explanation of the client's safety concerns and the duration of the client's life experience in their desired gender.
(II) The client has been evaluated for the presence of coexisting behavioral health conditions;
(III) Any coexisting behavioral health condition is adequately managed;
(IV) The client has been evaluated for the ability to comply with postoperative requirements and has the capacity to maintain lifelong changes; and
(V) Surgery is the next reasonable step in the client's care.
(iv) Hormone therapy. Documentation from the primary care provider or the provider prescribing hormone therapy that the client has:
(A) Taken hormones for a minimum of twelve continuous months immediately preceding the request for surgery, except for mastectomy or reduction mammoplasty; or
(B) A medical contraindication to hormone therapy; and
(C) A medical necessity for surgery and that the client is adherent with current gender dysphoria treatment.
(v) Surgical. Documentation from the surgeon of the client's:
(A) Medical history and physical examination(s) performed within the twelve months preceding surgery;
(B) Medical necessity for surgery and surgical plan;
(C) Post-operative plan for care; and
(D) For hysterectomies, a completed agency hysterectomy consent form must be submitted.
(c) Other requirements. If the client fails to complete all of the requirements in subsection (2)(b) of this section, the agency will not authorize gender affirming surgery unless:
(i) The clinical decision-making process is provided in the referral letter and attachments described in subsection (2)(b) of this section; and
(ii) The agency has determined that the request is medically necessary in accordance with WAC 182-501-0165 based on review of all submitted information.
(d) Behavioral health provider requirements. Behavioral health providers who perform the psychosocial evaluation described in subsection (2)(b)(i) of this section must:
(i) Meet the provisions of WAC 182-531-1400;
(ii) Be competent in using the Diagnostic Statistical Manual of Mental Disorders, and the International Classification of Diseases for diagnostic purposes;
(iii) Be able to recognize and diagnose coexisting mental health conditions and to distinguish these from gender dysphoria;
(iv) Be knowledgeable of gender-nonconforming identities and expressions, and the assessment and treatment of gender dysphoria; and
(v) Have completed 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.
(e) Clients age seventeen and younger. Clients age seventeen and younger must meet the requirements for prior authorization identified in subsection (2)(a) through (d) of this section, except that:
(i) One of the comprehensive psychosocial evaluations required in subsection (2)(b)(i) of this section must be performed by a behavioral health provider who specializes in adolescent transgender care and meets the qualifications outlined in WAC 182-531-1400.
(ii) For top surgery with or without chest reconstruction, the agency requires only one comprehensive psychosocial evaluation from a behavioral health provider who specializes in adolescent transgender care and meets the qualifications outlined in WAC 182-531-1400.
(3) Expedited prior authorization (EPA).
(a) Approved EPA procedures. The agency allows a provider to use the EPA process for clients age eighteen and older for the following medically necessary procedures:
(i) Bilateral mastectomy or reduction mammoplasty with or without chest reconstruction; and
(ii) Genital or donor skin graft site hair removal when medically necessary to prepare for genital reassignment.
(b) Clinical criteria and documentation. To use the EPA process for procedures identified in (a) of this subsection, the following clinical criteria and documentation must be kept in the client's record and made available to the agency upon request:
(i) One comprehensive psychosocial evaluation performed by a licensed behavioral health provider within the twelve months preceding surgery that meets the requirements identified in subsection (2) of this section.
(ii) Documentation from the primary care provider or the provider prescribing hormone therapy of the medical necessity for surgery and confirmation that the client is adherent with current gender dysphoria treatment; and
(iii) Documentation of medical necessity for surgery from the surgeon detailing the client's:
(A) Medical history and physical examinations performed within the twelve months preceding surgery;
(B) Surgical plan; and
(C) Post-operative plan for care.
(c) Documentation exception. When the requested procedure is for genital or donor skin graft site hair removal to prepare for bottom surgery, there is an exception to the requirements in (b) of this subsection. The only documentation required for that procedure is the provider's statement that the service is medically necessary to prepare for bottom surgery.
(d) Prior authorization required for other surgeries. All other surgeries to treat gender dysphoria, including modifications to, or complications from, a previous surgery, require prior authorization to determine medical necessity.
(e) Recoupment. The agency may recoup any payment made to a provider for procedures listed in this subsection if the provider does not follow the EPA process outlined in WAC 182-501-0163 or if the provider does not maintain the documentation required by this subsection.