HLT-50-14-00001-A Transgender Related Care and Services
3/11/15 N.Y. St. Reg. HLT-50-14-00001-A
NEW YORK STATE REGISTER
VOLUME XXXVII, ISSUE 10
March 11, 2015
RULE MAKING ACTIVITIES
DEPARTMENT OF HEALTH
NOTICE OF ADOPTION
I.D No. HLT-50-14-00001-A
Filing No. 129
Filing Date. Feb. 24, 2015
Effective Date. Mar. 11, 2015
Transgender Related Care and Services
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
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 authorize Medicaid coverage for transgender related care and services.
Text or summary was published
in the December 17, 2014 issue of the Register, I.D. No. HLT-50-14-00001-P.
Final rule as compared with last published rule:
No changes.
Text of 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
Assessment of Public Comment
Public comment was received from 91 commenters: 64 advocacy organizations; 10 lawyers or legal organizations; eight mental or physical health care professionals; one New York State agency; one New York State Senator; one New York State Assembly member; one New York City agency, and five individuals who did not indicate any affiliation. Six commenters identified themselves as a transgender individual or a family member of a transgender individual. Over 50 of the comments were virtually identical, following a template provided by an advocacy organization.
Only two commenters opposed the elimination of the current prohibition on Medicaid coverage of care, services, and supplies rendered for the purpose of, or to promote, gender reassignment. Another commenter objected at length to the current prohibition on coverage in 18 NYCRR § 505.2(l), but offered no comments on the Department’s proposed amendment to the regulation. One commenter advocated that section 505.2(l) simply be repealed, without replacement. The remaining 87 commenters supported the addition of transition-related transgender care and services to the Medicaid benefit package, but suggested changes to the proposed regulation.
Comment: The majority of commenters objected to the proposed regulation restricting coverage to individuals 18 years of age or older. Specifically, commenters recommended that Medicaid cover pubertal suppressants and cross-sex hormone therapy for children and adolescents under the age of 18.
Response: It is the policy of the New York State Medicaid program to only cover drugs that are for medically accepted indications. Federal Medicaid law at 42 U.S.C. 1396r–8(k)(6) defines “medically accepted indication” to mean any use approved by the Food and Drug Administration (FDA) or supported by one or more citations in official pharmaceutical compendia listed in 42 U.S.C. 1396r-8(g)(1)(B)(i).
Pubertal suppressants are neither FDA-approved nor compendia-supported for the treatment of gender dysphoria at any age. Cross-sex hormone therapy is not FDA-approved for the treatment of gender dysphoria; however, there is compendia support for using cross-sex hormone therapy to treat gender dysphoria, but only for individuals 18 years of age and older. Because pharmaceutical treatments for gender dysphoria in children and adolescents do not meet the federal Medicaid standards for a “medically accepted indication,” no changes to the proposed regulation were made as a result of these comments.
Comment: Many commenters objected to the proposed regulation specifying a minimum age of 21 for sex reassignment surgery that would result in sterilization. It was suggested that the Department is incorrectly interpreting the provisions of a federal Medicaid regulation at 42 CFR 441.253, which requires individuals to be at least 21 years of age at the time they consent to sterilization in order for the procedure to be covered by Medicaid.
Response: The Department has reviewed the provisions of 42 CFR 441.253, and considered them in conjunction with another federal Medicaid regulation specifying the criteria for coverage of hysterectomies. The Department has concluded that these regulations do not clearly indicate whether Medicaid may cover a procedure performed on an individual under 21 years of age that results in sterilization, but was not performed solely for the purpose of rendering the individual incapable of reproducing. The Department intends to seek guidance from the Centers for Medicare and Medicaid Services on the correct interpretation of these regulations; if such procedures may be covered, the Department will revise its policy in a subsequent rulemaking.
Comment: A number of commenters objected to the exclusion of cosmetic services from the services that Medicaid will cover to treat gender dysphoria.
Response: Federal and State law limit Medicaid coverage to payment for medically necessary care, services, and supplies. For this reason, the New York State Medicaid program does not cover purely cosmetic procedures. The proposed regulation therefore distinguishes between surgical procedures that are primary to gender reassignment, and ancillary procedures directed solely at improving an individual’s appearance. No changes to the proposed regulation were made as a result of these comments.
However, breast augmentation in male-to-female transitions may be primary to gender reassignment in certain limited circumstances. The Department plans to issue separate policy guidance setting forth criteria for coverage of breast augmentation, and will consider making a clarifying change to the regulation in a subsequent rulemaking.
Comment: Some commenters recommended that the Department strictly follow the standards of care recommended by the World Professional Association for Transgender Health (WPATH). Other commenters felt that the Department’s policy on Medicaid coverage for transgender care and services should be even more expansive, and described the WPATH recommendations as unnecessarily burdensome. Some commenters asked that certain prerequisites to coverage of sex reassignment surgery in the proposed regulation be eliminated (being diagnosed as having gender dysphoria; receiving 12 months of hormone therapy if seeking genital surgery, unless medically contraindicated; living for 12 months in a gender role congruent with the individual’s gender identity; or receiving mental health counseling, as deemed medically necessary). One commenter suggested that having the capacity to consent to the treatment should not be a prerequisite to an individual receiving care.
Response: In developing its policy, the Department reviewed standards of care recommended by professional organizations, including the WPATH, as well as those followed by commercial insurers and by the handful of other state Medicaid programs that cover transgender care and services. As the comments demonstrate, there is no universal agreement on one standard of care that should be followed. The proposed regulation sets forth a policy that will enable transgender individuals to receive medically necessary care, and that reflects the mainstream of current thinking with respect to transgender care and services. The proposed regulation also establishes reasonable prerequisites and criteria for coverage, designed to limit Medicaid payment to medically necessary care, and consistent with the Department’s responsibility under section 364 of the Social Services Law to ensure that the medical care and services paid for by the Medicaid program are of the highest quality. No changes to the proposed regulation were made as a result of these comments.
Comment: A number of comments dealt with the requirement that gender reassignment surgery be supported by referral letters from two qualified, licensed health care professionals. Some commenters recommended that only one referral letter be required for breast surgery. Some commenters stated that additional types of professionals (e.g. licensed marriage and family therapists, or licensed mental health counselors) should be able to supply a referral letter.
Response: The requirement for an authoritative diagnosis of gender dysphoria is necessary to ensure that Medicaid pays only for medically necessary care. The Department is willing to consider expanding the list of referring professionals in the future, but believes the current requirement is reasonable and will not be a barrier to transgender individuals accessing necessary care. Likewise, the Department will consider adopting a policy of requiring one referral letter for breast surgery, which is consistent with the policies of a number of other health insurance payers, but will address any such change in a subsequent rulemaking.
Comment: Some commenters raised a concern about gender-specific billing edits that might result in the rejection of Medicaid claims for non-transition-related care needed by transgender individuals (e.g., prostate-related care for a transgender individual whose assigned gender at birth was male but whose gender marker has been changed to female).
Response: This issue is beyond the intended scope of the regulation, and no changes were made to the proposed regulation in response to it. However, the Department will implement system edits to ensure access to non-transition-related care for individuals who are in the process of transitioning or have completed their transition.
Comment: Some commenters recommended that the Department establish an advisory committee to oversee implementation of the proposed regulation and/or develop and mandate transgender health competency training for its Medicaid providers.
Response: These comments address issues beyond the intended scope of the regulation, and no changes were made to the proposed regulation in response to them. However, the Department will take these comments under advisement.
