Patient Demographics/Information

NCPDP Comments

NCPDP recommends adding intersex (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.  By adding this additional value, this would allow providers to properly address patients and to be inclusive of all.

"Sex" data element should be removed

While there is broad industry implementation of Administrative Gender and Sex assigned at birth (SAAB), there is also wide agreement that the meaning of these data elements requires conjecture and they can be dangerous if used when the meaning is unclear.  Recommendation:

• Because the meaning around these concepts is unclear, we are supportive of removing ‘Sex assigned at Birth’ (as was done in USCDIv3).
• We recommend removing ‘Sex’, and instead consider adding clarification that the concepts of Gender Identity and Sex for Clinical Use are well-defined replacements for ‘Sex’ and the ‘Sex assigned at Birth’.

CMS-CCSQ Recommendation for Sex for USCDI v4

CMS repeats and supports the ISWG and HITAC recommendation for USCDI v3 (on April 13, 2022) to include the HL7 Gender Harmony Project’s data elements related to Sex – Recorded Sex or Gender (RSoG) and Sex for Clinical Use (SFCU) in addition to the existing standards for capturing sex. Further specification of data elements related to the concept of sex is necessary to improve health equity, represent diversity, and improve care, specifically for historically vulnerable and/or underserved populations – all ONC stated priorities for USCDI v4. For example, Sex for Clinical Use is critical because the appropriate sex value for an individual may differ for different procedures or tests. Likewise, Recorded Sex or Gender is critical because, depending on context, the value may change and not be the static value on an original birth certificate. These data elements allow the capture and exchange of more nuanced information, which is essential for proper care and will support patient care, care coordination, and quality measurement. These data elements were widely supported during USCDI v3 consideration and recommended by the ISWG and supported by HITAC. Maturity: These elements are classified as Level 2 by ONC.

• Current Standards:
  • CMS supports the ISWG USCDI v3 recommended minimum value sets (https://www.healthit.gov/sites/default/files/facas/2022-04-13_IS_WG_Phase_1_Recommendations_Report_revised.pdf), which are closely aligned with Gender Harmony recommendations, and represented by Logical Observation Identifiers Names and Codes (LOINC) terminology, for these critical data.
  • Recorded Sex or Gender: F[emale], M[ale], X [non-binary, intersex, unspecified, etc.], < [value not recorded or cannot be ascertained]
  • Sex for Clinical Use: Female, Male, Specified, Unknown
  • HL7 Cross Paradigm IG: Gender Harmony – Sex and Gender Representation (https://build.fhir.org/ig/HL7/fhir-gender-harmony/branches/main/index.html)

Current uses, exchange, and use cases: Elements related to sex are captured in nearly all clinical and administrative records. The information is routinely exchanged as part of healthcare information exchange. As more appropriate and diverse terminology are standardized, the capture and exchange of the data must also keep pace to ensure appropriate and high quality of care. CMS also uses sex and gender information for quality measurement and continues to support Gender Harmony project efforts, reflected in this recommendation.

CDC's comment on behalf of CSTE for USCDI v4

 

• CSTE agrees with CDC. 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

1. http://www.hl7.org/implement/standards/product_brief.cfm?product_id=564
2. 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).

CDC-CMS Joint Priority Data Element for USCDI

CDC continues to recommend inclusion of this high priority data element in USCDI v4.  This element is also shared high priority item for CMS/CDC as outlined in our joint letter

Sex is not gender. We…

Sex is not gender. We recommend use of CDC definitions for sex at birth. This is a fixed value.   https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.113883.1.11.1   There are several standards systems in use for separately identifying gender. In the AAPM Operational Ontology for Radiation Oncology the HL7 Reference system is used.  http://hl7.org/fhir/2018May/codesystem-gender-identity.html   Other systems evaluated were  CDC https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.113883.1.11.1 DICOM http://dicom.nema.org/medical/dicom/current/output/chtml/part16/sect_CID_7455.html#table_CID_7455 Health IT https://www.healthit.gov/isa/representing-patient-gender-identity LOINC https://loinc.org/76691-5/

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.