HLT-19-16-00008-P Transgender Related Care and Services

5/11/16 N.Y. St. Reg. HLT-19-16-00008-P

NEW YORK STATE REGISTER

VOLUME XXXVIII, ISSUE 19

May 11, 2016

RULE MAKING ACTIVITIES

DEPARTMENT OF HEALTH

PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. HLT-19-16-00008-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; and Social Services Law, sections 363-a and 365-a(2)

Subject:

Transgender Related Care and Services.

Purpose:

To revise and clarify the criteria for Medicaid coverage of transgender related 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) Hormone therapy, whether or not in preparation for gender reassignment surgery, may be covered for individuals 18 years of age or older.

(3) Gender reassignment surgery may 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) has a persistent and well-documented case of gender dysphoria;

(ii) 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) 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) 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) has the capacity to make a fully informed decision and to consent to the treatment.

(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 [; and].

(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:

[(v) cosmetic surgery, services, and procedures, including but not limited to:]

[(a)] (i) abdominoplasty, blepharoplasty, neck tightening, or removal of redundant skin;

[(b)] (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;

[(c)] (iii) breast, brow, face, or forehead lifts;

[(d)] (iv) calf, cheek, chin, nose, or pectoral implants;

[(e)] (v) collagen injections;

[(f)] (vi) drugs to promote hair growth or loss;

[(g)] (vii) electrolysis, unless required for vaginoplasty or phalloplasty;

[(h)] (viii) facial bone reconstruction, reduction, or sculpturing, including jaw shortening and rhinoplasty;

[(i)] (ix) hair transplantation;

[(j)] (x) lip reduction;

[(k)] (xi) liposuction;

[(l)] (xii) thyroid chondroplasty; and

[(m)] (xiii) voice therapy, voice lessons, or voice modification surgery.

[(5)] (6) For purposes of this subdivision, cosmetic surgery, services, and procedures refers to anything solely directed at improving an individual’s appearance.

[(6)] (7) 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, [phone], email: [e-mail]

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 treatments to address gender dysphoria, to clarify the policy with respect to coverage for presumptively cosmetic surgery, services, and procedures.

The existing regulation provides that Medicaid will not pay for surgery, services, or procedures performed in connection with GRS that are purely cosmetic, and defines “cosmetic surgery, services, and procedures” as anything solely directed at improving an individual’s appearance. However, the existing regulation may not be clear that an ostensibly cosmetic procedure listed in the regulation may be covered if it is established that it is medically necessary in a particular case and not solely directed at improving appearance. Therefore, consistent with the Department’s published written guidance interpreting the regulation, the proposed amendments would add language clarifying that the listed surgery, services or procedures are presumed to be cosmetic, i.e., performed solely for the purpose of improving appearance, and will not be covered unless justification of medical necessity is provided and prior approval is granted. The proposed amendments would renumber paragraphs (5) and (6) of § 505.2(l) as paragraphs (6) and (7), and place the list of presumptively cosmetic procedures and the clarifying language into a new paragraph (5).

Similarly, the newly numbered § 505.2(l)(5) would be amended to reflect and refine interpretative guidance issued by the Department with respect to the coverage of breast augmentation and the coverage of electrolysis. The proposed amendments would provide that: breast augmentation will be covered, without the need for prior approval, if an 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; and that necessary electrolysis will be covered, without the need for prior approval, as part of the Medicaid payment for both vaginoplasty and phalloplasty.

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:

The proposed amendments would not change the Department’s current policy with respect to the availability of Medicaid coverage for ostensibly cosmetic procedures in connection with GRS, but would simply clarify regulatory language to more clearly state that policy. There will be no additional costs to the Medicaid program as a result of making these clarifications.

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 the paperwork requirements for a medical provider to document the need for hormone therapy or GRS.

Duplication:

There are no duplicative or conflicting rules identified.

Alternatives:

Advocates for individuals with gender dysphoria and a federal court have both interpreted the existing regulatory language, as regards the availability of Medicaid coverage for ostensibly cosmetic procedures in connection with GRS, inconsistently with the Department’s intent. Therefore the Department concluded that there is no alternative to clarifying the regulatory language.

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.