HLT-40-16-00030-P Transgender Related Care and Services  

  • 10/5/16 N.Y. St. Reg. HLT-40-16-00030-P
    NEW YORK STATE REGISTER
    VOLUME XXXVIII, ISSUE 40
    October 05, 2016
    RULE MAKING ACTIVITIES
    DEPARTMENT OF HEALTH
    PROPOSED RULE MAKING
    NO HEARING(S) SCHEDULED
     
    I.D No. HLT-40-16-00030-P
    Transgender Related Care and Services
    PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
    Proposed Action:
    Amendment of section 505.2(l) of Title 18 NYCRR.
    Statutory authority:
    Public Health Law, sections 201 and 206; Social Services Law, sections 363-a and 365-a(2)
    Subject:
    Transgender Related Care and Services.
    Purpose:
    To amend provisions regarding Medicaid coverage of transition-related transgender care and services.
    Text of proposed rule:
    Subdivision (l) of section 505.2 is amended to read as follows:
    (l) Gender dysphoria treatment.
    (1) As provided in this subdivision, payment is available for medically necessary hormone therapy and/or gender reassignment surgery for the treatment of gender dysphoria.
    (2)(i) Hormone therapy, whether or not in preparation for gender reassignment surgery, [may] shall be covered [for individuals 18 years of age or older.] as follows:
    (a) treatment with gonadotropin-releasing hormone agents (pubertal suppressants), based upon a determination by a qualified medical professional that an individual is eligible and ready for such treatment, i.e., that the individual:
    (1) meets the criteria for a diagnosis of gender dysphoria;
    (2) has experienced puberty to at least Tanner stage 2, and pubertal changes have resulted in an increase in gender dysphoria;
    (3) does not suffer from psychiatric comorbidity that interferes with the diagnostic work-up or treatment;
    (4) has adequate psychological and social support during treatment; and
    (5) demonstrates knowledge and understanding of the expected outcomes of treatment with pubertal suppressants and cross-sex hormones, as well as the medical and social risks and benefits of sex reassignment;
    (b) treatment with cross-sex hormones for patients who are sixteen years of age and older, based upon a determination of medical necessity made by a qualified medical professional; patients who are under eighteen years of age must meet the applicable criteria set forth in clause (a).
    (ii) Notwithstanding the requirement in clause (b) of subparagraph (i) of this paragraph that an individual be sixteen years of age or older, payment for cross-sex hormones for patients under sixteen years of age who otherwise meet the requirements of clause (b) of subparagraph (i) of this paragraph shall be made in specific cases if medical necessity is demonstrated and prior approval is received.
    (3)(i) Gender reassignment surgery [may] shall be covered for an individual who is 18 years of age or older and has letters from two qualified New York State licensed health professionals who have independently assessed the individual and are referring the individual for the surgery. One of these letters must be from a psychiatrist, psychologist, or psychiatric nurse practitioner with whom the individual has an established and ongoing relationship. The other letter may be from a [licensed] psychiatrist, psychologist, physician, psychiatric nurse practitioner, or licensed clinical social worker acting within the scope of his or her practice, who has only had an evaluative role with the individual. Together, the letters must establish that the individual:
    [(i)] (a) has a persistent and well-documented case of gender dysphoria;
    [(ii)] (b) has received hormone therapy appropriate to the individual's gender goals, which shall be for a minimum of 12 months in the case of an individual seeking genital surgery, unless such therapy is medically contraindicated or the individual is otherwise unable to take hormones;
    [(iii)] (c) has lived for 12 months in a gender role congruent with the individual’s gender identity, and has received mental health counseling, as deemed medically necessary, during that time;
    [(iv)] (d) has no other significant medical or mental health conditions that would be a contraindication to gender reassignment surgery, or if so, that those are reasonably well-controlled prior to the gender reassignment surgery; and
    [(v)] (e) has the capacity to make a fully informed decision and to consent to the treatment.
    (ii) Notwithstanding subparagraph (i) of this paragraph, payment for gender reassignment surgery, services, and procedures for patients under eighteen years of age may be made in specific cases if medical necessity is demonstrated and prior approval is received.
    [(4) Payment will not be made for the following services and procedures:
    (i) cryopreservation, storage, and thawing of reproductive tissue, and all related services and charges;
    (ii) reversal of genital and/or breast surgery;
    (iii) reversal of surgery to revise secondary sex characteristics; and
    (iv) reversal of any procedure resulting in sterilization.
    (5) Payment will not be made for any surgery, services, or procedures that are performed solely for the purpose of improving an individual's appearance (cosmetic procedures). The following surgery, services, and procedures will be presumed to be cosmetic and will not be covered, unless justification of medical necessity is provided and prior approval is received:
    (i) abdominoplasty, blepharoplasty, neck tightening, or removal of redundant skin;
    (ii) breast augmentation, unless the individual has completed a minimum of 24 months of hormone therapy during which time breast growth has been negligible, or hormone therapy is medically contraindicated or the individual is otherwise unable to take hormones;
    (iii) breast, brow, face, or forehead lifts;
    (iv) calf, cheek, chin, nose, or pectoral implants;
    (v) collagen injections;
    (vi) drugs to promote hair growth or loss;
    (vii) electrolysis, unless required for vaginoplasty or phalloplasty;
    (viii) facial bone reconstruction, reduction, or sculpturing, including jaw shortening and rhinoplasty;
    (ix) hair transplantation;
    (x) lip reduction;
    (xi) liposuction;
    (xii) thyroid chondroplasty; and
    (xiii) voice therapy, voice lessons, or voice modification surgery.]
    (4) For individuals meeting the requirements of subdivision (3) of this section, Medicaid coverage will be available for the following gender reassignment surgeries, services, and procedures, based upon a determination of medical necessity made by a qualified medical professional:
    (i) mastectomy, hysterectomy, salpingectomy, oophorectomy, vaginectomy, urethroplasty, metoidioplasty, phalloplasty, scrotoplasty, penectomy, orchiectomy, vaginoplasty, labiaplasty, clitoroplasty, and/or placement of a testicular prosthesis and penile prosthesis;
    (ii) breast augmentation, provided that: the patient has completed a minimum of 24 months of hormone therapy, during which time breast growth has been negligible; or hormone therapy is medically contraindicated; or the patient is otherwise unable to take hormones;
    (iii) electrolysis when required for vaginoplasty or phalloplasty; and
    (iv) such other surgeries, services, and procedures as may be specified by the Department in billing guidance to providers.
    [(6)] (5) [For purposes of this subdivision, cosmetic surgery, services, and procedures refers to anything solely directed at improving an individual’s appearance.] For individuals meeting the requirements of subdivision (3) of this section, surgeries, services, and procedures in connection with gender reassignment not specified in subdivision (4) of this section, or to be performed in situations other than those described in such subdivision, including those done to change the patient’s physical appearance to more closely conform secondary sex characteristics to those of the patient’s identified gender, shall be covered if it is demonstrated that such surgery, service, or procedure is medically necessary to treat a particular patient’s gender dysphoria, and prior approval is received. Coverage is not available for surgeries, services, or procedures that are purely cosmetic, i.e., that enhance a patient’s appearance but are not medically necessary to treat the patient’s underlying gender dysphoria.
    [(7)] (6) All legal and program requirements related to providing and claiming reimbursement for sterilization procedures must be followed when transgender care involves sterilization.
    Text of proposed rule and any required statements and analyses may be obtained from:
    Katherine Ceroalo, DOH, Bureau of House Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.ny.gov
    Data, views or arguments may be submitted to:
    Same as above.
    Public comment will be received until:
    45 days after publication of this notice.
    This rule was not under consideration at the time this agency submitted its Regulatory Agenda for publication in the Register.
    Regulatory Impact Statement
    Statutory Authority:
    Social Services Law (SSL) section 363-a and Public Health Law section 201(1)(v) provide that the Department is the single State agency responsible for supervising the administration of the State’s medical assistance (“Medicaid”) program and for adopting such regulations, which shall be consistent with law, and as may be necessary to implement the State’s Medicaid program. SSL section 365-a authorizes Medicaid coverage for specified medical care, services and supplies, together with such medical care, services and supplies as authorized in the regulations of the Department.
    Legislative Objective:
    Section 365-a of the SSL requires Medicaid to pay for part or all of the cost of medical, dental, and remedial care, services, and supplies that are necessary to prevent, diagnose, correct or cure conditions that cause acute suffering, endanger life, result in illness or infirmity, interfere with a person's capacity for normal activity, or threaten some significant handicap.
    Needs and Benefits:
    The proposed amendments would revise the Department’s existing regulations providing for Medicaid coverage of medically necessary treatments to address gender dysphoria (GD) to: provide coverage of such treatments for individuals under 18 years of age; specify gender reassignment surgeries, services, and procedures that the Medicaid program will cover without the need for the practitioner to obtain prior approval; reiterate that Medicaid will cover other surgeries, services, and procedures, including those done to change an individual’s physical appearance to more closely conform secondary sex characteristics to those of the patient’s identified gender, if it is demonstrated that such surgery, service, or procedure is medically necessary to treat a particular patient’s GD, and prior approval is received; and remove language in the regulation specifying certain coverage limitations, in favor of including that information in other Medicaid policy materials.
    The existing regulation provides coverage for hormone therapy only for individuals 18 years of age or older. When the Department proposed the original regulation providing for Medicaid coverage of transgender care and services, it had reservations about the safety and efficacy, and thus the medical necessity, of hormone therapy for individuals under 18 with GD. For one thing, the use of hormone therapy to treat GD in individuals under the age of 18 is not approved by the federal Food and Drug Administration (FDA), nor is it indicated as an accepted off-label use by any of the pharmaceutical compendia relied on by the Medicaid program; this may be due to the apparent dearth of quality, longitudinal studies on the long term effects of providing such treatments to the under 18 population. In addition, at the time of the original regulation, virtually no other health care payer provided coverage of hormone therapy for individuals under age 18; this may have been due, in part, to the lack of FDA approval or pharmaceutical compendia support.
    Since then, the Department has observed the beginning of a shift in payer policies with respect to treatment for the under 18 population, and has had the opportunity to talk to a number of practitioners who treat minors with GD, to benefit from their clinical experiences and to solicit their understanding of the current consensus in the medical profession, if any, with respect to such treatment.
    All of these practitioners were of the opinion that the use of pubertal suppressants and cross-sex hormone therapy could be medically necessary in the treatment of GD in individuals under age 18. They acknowledged that it would be ideal if more high quality studies were available on the long-term effects of the treatments, but all believed that the positive effects they have observed in the short term in improving the mental health of minors with GD outweigh the potential long-term risks. The practitioners were in agreement that pubertal suppressants do not need to be prescribed before an individual reaches Tanner stage 2 in pubertal development. With respect to the current standard of care for treating minors with GD, the practitioners were also generally consistent in stating that cross-sex hormone treatment typically is not started until the individual reaches 16 years of age, and surgical interventions to treat GD typically are not recommended before the individual reaches 18 years of age, although exceptions might be appropriate in particular cases. This is consistent with existing guidelines issued by the Endocrine Society with respect to the use of pubertal suppressants and cross-sex hormone therapy to treat GD in individuals under 18 years of age, and suggests that the Endocrine Society guidelines are reflective of a generally accepted standard of care for treating GD in this age group.
    Therefore, the Department is proposing to amend the regulations to adopt criteria for Medicaid payment for pubertal suppressants and cross-sex hormones for individuals under age 18. These criteria are modeled closely after those set forth in the current Endocrine Society guidelines.
    The proposed amendments would provide for coverage of pubertal suppressants in the treatment of GD based on the determination of a qualified medical professional that an individual is eligible and ready for the treatment. An individual would be considered eligible and ready for treatment with pubertal suppressants if the individual: meets the criteria for a diagnosis of GD; has experienced puberty to at least Tanner stage 2, and pubertal changes have resulted in an increase in gender dysphoria; does not suffer from psychiatric comorbidity that interferes with the diagnostic work-up or treatment; has adequate psychological and social support during treatment; and demonstrates knowledge and understanding of the expected outcomes of treatment with pubertal suppressants and cross-sex hormones, as well as the medical and social risks and benefits of sex reassignment.
    The proposed amendments would provide for coverage of treatment with cross-sex hormones for individuals who are 16 years of age or older, based on a determination of medical necessity by a qualified medical professional. An individual under 18 years of age would have to meet the same criteria as for treatment with pubertal suppressants, as applicable.
    The proposed amendments would also provide for coverage of cross-sex hormones for individuals under age 16, and for coverage of gender reassignment surgeries, services, and procedures for individuals under age 18, in individual cases if medical necessity is demonstrated and prior approval is received.
    The proposed changes therefore would make Medicaid coverage of transgender care and services available, regardless of an individual’s age, when such care and services are medically necessary to treat the individual’s gender dysphoria.
    Commenters on the current regulation have objected to the designation of certain surgeries, services, and procedures as presumptively cosmetic, and to the inclusion in the regulation of information about coverage limitations related to cryopreservation of reproductive tissue and reversal of gender reassignment surgeries. The commenters contended that such provisions have the effect of treating individuals with GD differently than other Medicaid recipients, and imposing stricter prior approval standards on individuals with GD than are applied to individuals with other conditions or diagnoses. The Department does not agree with the commenters on these points, but is proposing changes to the regulation in order to be sensitive to their concerns and to try to avoid any misconceptions about Medicaid’s policy.
    First, the proposed amendments would remove the list of presumptively cosmetic surgeries, services, and procedures from the regulation. Instead, the proposed amendments would specifically list gender reassignment surgeries, services, and procedures that Medicaid will cover without the need for prior approval. The proposed amendments would further provide that any surgeries, services, and procedures not on this list or otherwise specified by the Department in billing guidance to Medicaid providers, would be subject to prior approval and covered if medically necessary to treat the individual’s gender dysphoria. This would include surgeries, services, and procedures for the purpose of changing an individual’s appearance to more closely conform secondary sex characteristics to those of the patient’s identified gender. The regulation would continue to provide that Medicaid coverage is not available for surgeries, services, and procedures that are purely cosmetic, i.e., that enhance an individual’s appearance but are not medically necessary to treat the individual’s underlying gender dysphoria.
    Second, the proposed amendments would remove the language regarding cryopreservation of reproductive tissue and the reversal of gender reassignment surgeries; instead, the Department will provide this information in billing guidance to Medicaid providers or other policy materials.
    Commenters had also requested that licensed clinical social workers be added to the list of licensed New York State health professionals, with whom an individual has an established and ongoing relationship, who can provide a letter referring the individual for gender reassignment surgery. Because licensed clinical social workers in New York State are qualified to diagnose GD, the Department is comfortable adding them to this list. The proposed amendments would make this change.
    Finally, the proposed amendments would make a number of minor, nonsubstantive changes to clarify existing regulatory language.
    Costs:
    Costs to Regulated Parties:
    The proposed amendment pertains to a covered benefit under the State’s Medicaid program. The amendment would not increase costs to regulated parties.
    Costs to State Government:
    There may be costs to the Medicaid program associated with increased use of pubertal suppressants. Generally, however, the proposed amendments do not expand the Medicaid benefit package, but simply allow Medicaid recipients to receive covered transition-related transgender care and services at a younger age, and thus should not generate significant additional costs to the program.
    Costs to Local Governments:
    Local social services districts’ share of Medicaid costs is statutorily capped; therefore, there will be no additional costs to local governments as a result of the proposed amendment.
    Costs to the Department of Health:
    There will be no additional costs to the Department.
    Local Government Mandates:
    This amendment will not impose any program, service, duty, additional cost, or responsibility on any county, city, town, village, school district, fire district, or other special district.
    Paperwork:
    The proposed amendments would not increase paperwork requirements.
    Duplication:
    There are no duplicative or conflicting rules identified.
    Alternatives:
    Given the Department’s current understanding that the use of pubertal suppressants and cross-sex hormone therapy may be medically necessary in the treatment of GD in individuals under age 18, it has concluded that there is no alternative to changing its coverage policy and making necessary conforming amendments to the existing regulation.
    Federal Standards:
    The proposed regulations do not exceed any minimum federal standards.
    Compliance Schedule:
    Regulated parties should be able to comply with the proposed regulations when they become effective.
    Regulatory Flexibility Analysis
    No regulatory flexibility analysis is required pursuant to section 202-(b)(3)(a) of the State Administrative Procedure Act. The proposed amendment pertains to a covered benefit under the State’s Medicaid program. It would not impose an adverse economic impact on small businesses or local governments, and it would not impose reporting, record keeping or other compliance requirements on small businesses or local governments.
    Rural Area Flexibility Analysis
    A Rural Area Flexibility Analysis for the proposed amendments is not being submitted because the amendments would not impose any adverse impact or significant reporting, record keeping or other compliance requirements on public or private entities in rural areas. There would be no professional services, capital, or other compliance costs imposed on public or private entities in rural areas as a result of the proposed amendments.
    Job Impact Statement
    A Job Impact Statement for the proposed amendments is not being submitted because it is apparent from the nature and purpose of the amendment that it would not have a substantial adverse impact on jobs and/or employment opportunities.

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