Additional Supporting Documentation for CDC's SOGI Submission

Please see the attachment

ONC Letter of Comment for SOGI v3.docx

CDC's comment on behalf of ASTHO (WA DOH)

Subject: Additional values in the valueset Comment: Current birth sex representation values categorizes everything other than ‘Male’ and ‘Female’ into ‘Unknown’. It is important to disaggregate further to accurately represent birth sex categories other than the two mentioned above to evaluate and reflect the needs of the other genders. The gender valueset being proposed is as follows:  

• Male
• Female
• Intersex*
• X*
• Not listed, please describe*
• Unknown

*New values being proposed

CDC's Consolidated Comment

• Addressing health equity tasks through the USCDI in a scope of the SOGI, the USCDI should contain 5 data elements (Gender Identity, Sex assigned at birth, Sexual Orientation, Sex for Clinical Use Note and Patient Pronoun). The last two mentioned data elements were not included into the v.3. We recommend including the Sex for Clinical Use Note (within the Clinical Notes data class) and Patient Pronoun (within the Patient Demographic) into the next, the USCDI v.4 version.
• Because the USCDI v.3 does not provide a definition of the Sex (Assigned at Birth) data element, we recommend to add the following description: As defined by NASEM in its 2022 report “Measuring Sex, Gender Identity, and Sexual Orientation”, the Sex (Assigned at Birth) is a multidimensional construct based on a cluster of anatomical and physiological traits (sex traits) such as external genitalia, secondary sex characteristics, gonads, chromosomes, and hormones. Sex (Assigned at Birth) has the following characteristics: it usually assigned as female or male; most often it defined at birth based on visual inspection of external genitalia; sex traits usually assumed to be unambiguous; sex traits usually assumed to correspond to the same sex; some sex traits can change or be altered over time. The Sex (Assigned at Birth) is considered a fixed data point and reflected on an individual’s original birth certificate.
• The present version of the USCDI, v3. does not include a LOINC code associated with the Sex (Assigned at Birth) question. We propose to fix this gap by adding the LOINC code 76689-9, Sex assigned at birth.
• In addition to 3 response options presented by the USCDI v.3 for the Sex Assigned at Birth data element (Female. F; Male. M; Unknown. nullFlavor UNK) we suggest incorporating the following 3 optional HL7 V3 NullFlavor codes. These  codes were included into the ONC ISA for Representing Patient Sex (At Birth): OTH ("Other"), ASKU ("Asked, but Unknown") and NASK ("Not asked"). Adding these codes benefits respondents and respects their privacy and confidentiality (privacy).

CSTE Comment:

• While more work is needed to develop public health community consensus on the best way to collect and exchange data on gender identity, and there is variability in how these data are collected by health care as well as by health departments, CSTE supports the use of multiple questions to describe gender identity and sex, specifically Gender Identity and EITHER Sex Assigned at Birth OR Sex for Clinical Use (a category that is based upon clinical observations typically associated with the
• designation of male and female). The latter has been put forward by the HL7 Gender Harmony project (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=564 http://www.hl7.org/documentcenter/private/standards/HL7_GENDER_R1_INFORM_2021AUG.pdf ). Sex assigned at birth as a term may cause problems for members of the transgender community especially for those who opt to correct or revise their sex on a birth certificate.
• Values for gender identity should include male, female, nonbinary, exploring or questioning, another not listed (specify), choose not to disclose, and unknown. CSTE recommends that the terms transgender, female to male and transgender male to female be deprecated.
• Values for sex for clinical use should include female, male, unknown, and something not listed (specify).

NCPDP Comments on USCDI draft V3

Recommend adding Intersex (NCPDP Definition: An individual born with any of several variations in sex characteristics, including chromosomes, gonads, sex hormones or genitals that do not fit the typical definitions of male or female) to “Sex (Assigned at Birth)” to align with the values NCPDP has defined.

Remove this category

Sex is a complex set of phenotypes that are not adequately expressed in binary categories, nor is assignment at birth an accurate or useful assessment. This term encompasses primary and secondary sex traits, few of which are identifiable at birth, and there are many possible combinations of these in a given individual. Sex also does not correspond cleanly to chromosomal DNA, which has many possible combinations and which also may not correspond with the development of the body, either with or without medical intervention. Although several of the traits comprising sex are useful in medicine, a single sex designation assigned at birth is not. In short, this is a reductive and obsolete classifier that should be removed entirely. This data field is also highly likely to miscategorize intersex people regardless of the options offered. Although it is now possible to assign a legal gender marker of 'X' in many states, a majority of intersex people have a binary female or male sex assigned at birth that does not accurately describe them.

Sex ID Revision

Sex is a complex set of phenotypes that are not adequately expressed in binary categories, nor is assignment at birth an accurate or useful assessment. This term encompasses primary and secondary sex traits, few of which are identifiable at birth, and there are many possible combinations of these in a given individual. Sex also does not correspond cleanly to chromosomal DNA, which has many possible combinations and which also may not correspond with the development of the body, either with or without medical intervention. Although several of the traits comprising sex are useful in medicine, a single sex designation assigned at birth is not. In short, this is a reductive and obsolete classifier that should be removed entirely.   The concept of sex assigned at birth as an immutable personal characteristic is particularly problematic for transgender people, for whom this designation is definitionally incongruent with their present understanding and lived identity, and for intersex people, for whom either single sex assigned at birth is inaccurate. The decision to keep a record of sex assigned at birth in the legal system does great harm to these populations as it is used to approve or deny eligibility for medical procedures, among other use cases, instead of an individual's current body, lived experience, and actual needs. It is also an unnecessary complication when a person's sex can be updated on only some forms of ID depending on state laws, frequently resulting in barriers to travel and administrative headaches. It is in the best interest of all parties to abolish this outdated practice of using sex assigned at birth in any legal capacity whatsoever.   This data field is also highly likely to miscategorize intersex people regardless of the options offered. Although it is now possible to assign a legal gender marker of 'X' in many states, a majority of intersex people have a binary female or male sex assigned at birth that does not accurately describe them. A separate question may better handle this matter. Please see http://web.archive.org/web/20210412083828/https://interactadvocates.org/intersex-data-collection/ for further discussion.  

Do not use sex assigned at birth in any legal capacity

Sex is a complex set of phenotypes that are not adequately expressed in binary categories, nor is assignment at birth an accurate or useful assessment. This term encompasses primary and secondary sex traits, few of which are identifiable at birth, and there are many possible combinations of these in a given individual. Sex also does not correspond cleanly to chromosomal DNA, which has many possible combinations and which also may not correspond with the development of the body, either with or without medical intervention. Although several of the traits comprising sex are useful in medicine, a single sex designation assigned at birth is not. In short, this is a reductive and obsolete classifier that should be removed entirely.   The concept of sex assigned at birth as an immutable personal characteristic is particularly problematic for transgender people, for whom this designation is definitionally incongruent with our present understanding and lived identity, and for intersex people, for whom either single sex assigned at birth is inaccurate. The decision to keep a record of sex assigned at birth in the legal system does great harm to these populations as it is used to approve or deny eligibility for medical procedures, among other use cases, instead of an individual's current body, lived experience, and actual needs. It is also an unnecessary complication when a person's sex can be updated on only some forms of ID depending on state laws, frequently resulting in barriers to travel and administrative headaches. It is in the best interest of all parties to abolish this outdated practice of using sex assigned at birth in any legal capacity whatsoever.   This data field is also highly likely to miscategorize intersex people regardless of the options offered. Although it is now possible to assign a legal gender marker of 'X' in many states, a majority of intersex people have a binary female or male sex assigned at birth that does not accurately describe them. A separate question may better handle this matter. Please see http://web.archive.org/web/20210412083828/https://interactadvocates.org/intersex-data-collection/ for further discussion.  

Sex is a complex set of…

Sex is a complex set of phenotypes that are not adequately expressed in binary categories, nor is assignment at birth an accurate or useful assessment. This data field also has no way to categorize intersex people. It should be removed entirely. The terms Female-to-Male and Male-to-Female listed here are obsolete and inappropriate. Binary trans women and men may be correctly identified simply as women and men, without separate categories, and nonbinary trans people as nonbinary.

I agree with previous…

I agree with previous commenters about this set being incomplete and out of step with a number of states which issue "X" birth certificates. This could make such individuals ineligible for a number of life-saving government programs, being unable to sign up without perjuring themselves. (see Princess Janae Place et al v. NY State OTDA et al, for more info: https://www.nyclu.org/en/cases/princess-janae-place-et-al-v-ny-state-office-temporary-and-disability-assistance-et-al). Myself and 16 other trans people wrote recommendations for assigned gender at birth (AGAB) as an extension to the HL7 Gender Harmony Project's Recorded Sex or Gender because some governments are considered removal of gender markers from birth certificates and that may happen in the near future. Not preparing for such an eventuality will cause further problems down the road. Therefore we suggested (https://doi.org/10.1093/jamia/ocab136): "What is your assigned gender at birth, meaning the gender marker which appears on your original birth certificate? Choose one. - Female ("F") - Male ("M") - X - Unsure - Prefer not to respond or disclose - Assigned gender at birth not listed (please specify): ___________" (this is necessary because many countries issue other letters on birth certificates, such as "E" in India or "D" in Germany)"   Unknown would still be the nullflavor in this case. Intersex is not included as an option because nowhere in the U.S. uses intersex as an AGAB. Intersex people are usually assigned male or female at birth. I suggest reading what intersex people have written themselves on data collection here: http://web.archive.org/web/20210412083828/https://interactadvocates.org/intersex-data-collection/.

Additional values in the value set

: Current birth sex representation values categorizes everything other than ‘Male’ and ‘Female’ into ‘Unknown’. It is important to disaggregate further to accurately represent birth sex categories other than the two mentioned above to evaluate and reflect the needs of the other genders. The gender value set being proposed is as follows:

• Male
• Female
• Intersex*
• X*
• Not listed, please describe*
• Unknown 

  *=New values being proposed