Health Status Assessments

PACIO Recommends ICF as an Applicable Vocabulary Standard

• Data Class: Health Status Assessments
• Data Element: Functional Status, Health Concerns, and Mental/Cognitive Status (Draft V6)
• Recommendation: Add the International Classification of Functioning, Disability and Health (ICF) as an Applicable Vocabulary Standard to the Functional Status, Health Concerns, and Mental/Cognitive Status data elements.
• Rationale: The PACIO Project Community* recommends the addition of the International Classification of Functioning, Disability and Health (ICF) as an Applicable Vocabulary Standard to the Functional Status, Health Concerns, and Mental/Cognitive Status data elements. No other ontologies meet the needs of post-acute care as ICF can. The ICF was created in 2001 to classify functioning domains as a consequence of health conditions, which are not completely captured by any other codeable concept ontology. The ICF ontology allows users to precisely categorize information on mental, cognitive, and functional factors, as well as health concerns. It can also build in an additional layer of clinical context which is also machine readable. The overarching ICF domains include body structures, body functions, activities and participation, personal factors, and environmental factors.
• Extensive guidance has also been created based on the use of ICF as a foundation for using Natural Language Processing models to capture free-text functioning information from electronic health records, specifically in the domains relating to mobility, self-care & domestic life, interpersonal interactions and relationships, and communication & cognition.
• Use of ICF has been recommended or endorsed by The National Committee on Vital and Health Statistics (NCVHS) and the American Physical Therapy Association. The American Speech-Language-Hearing Association (ASHA) provides information on how to use the ICF. CMS and the CDC provide guidance on using the ICF.
• The PACIO Project makes extensive use of the ICF ontology in the Personal and Functional Engagement (PFE) FHIR IG STU-2 as category codes for several profiles. This information captures both clinician insight and in the case of health concerns, allows patients to relate clinical problems to the way they interact with the world in a discrete and machine-readable way. For instance, a patient that has a problem with the structures in their knee might categorize their concern using concepts that describe their ability to play a sport, exercise, navigate their home, or participate in their community, while their rehab team may use concepts related to the functions and structures of the knee, thus building a more complete picture of the problem and why it is important to the patient.
• * The PACIO (Post-Acute Care Interoperability) Project, established February 2019, is a collaborative effort between industry, government, and other stakeholders, with the goal of establishing a framework for the development of FHIR implementation guides to facilitate health information exchange.

PACIO Recommends ASHA FCMs as an Applicable Vocabulary Standard

• Data Class: Health Status Assessments
• Data Element: Functional Status and Mental/Cognitive Status (Draft V6)
• Recommendation: Expand the definitions of Functional Status and Mental/Cognitive Status data elements to include the American Speech-Language-Hearing Association (ASHA) Functional Communication Measures (FCMs) that have assigned LOINC codes.
• Rationale: The PACIO Project Community* recommends including the American Speech-Language-Hearing Association (ASHA) Functional Communication Measures (FCMs) that have been assigned LOINC codes, e.g., 99836-9 and 99844-3, in the definitions of the Functional Status and Mental/Cognitive Status data elements to demonstrate the capability in each of these domains for capturing communication specific health information. The FCMs are the discipline standard for speech, language, and hearing assessments and are part of a National Outcomes Measurement System (NOMS) that includes data since initial collection started in 1998 and has been recommended by CMS for use by speech language pathologists in 2007. In 2013, ASHA launched a new version of NOMS to help report functional outcomes to support compliance with CMS requirements to “report all outcomes data on all Medicare Part B beneficiaries receiving speech-language services”. Given the importance of the NOMS, which includes FCMs, in assessing patients with speech and language needs, as well as alignment of NOMS with CMS requirements (along with CMS recommendations to use NOMS), including the definitions of Functional Status and Mental/Cognitive Status would be in line with the data that are already being collected systematically. This would help support interoperability of systems used by organizations already collecting these data. 
• These data are captured under both Functional Status and Cognitive Status as part of a published FHIR IG titled Personal Functioning and Engagement v 1.0.0, and in another FHIR IG currently in ballot under the same title v 2.0.0, compliant with US Core 6.1.0.
• * The PACIO (Post-Acute Care Interoperability) Project, established February 2019, is a collaborative effort between industry, government, and other stakeholders, with the goal of establishing a framework for the development of FHIR implementation guides to facilitate health information exchange.

PACIO Requests Expansion of Definitions

• Data Class: Currently Health Status Assessments (V5) 
• Data Element: Functional Status (V5) and Mental/Cognitive Status (V5) 
• Recommendation: Expand the definitions of these data elements to include the American Speech–Language–Hearing Association (ASHA) Functional Communication Measures (FCMs) as possible assessments. 
• Rationale: The PACIO (Post-Acute Care Interoperability) Project, established February 2019, is a collaborative effort between industry, government, and other stakeholders, with the goal of establishing a framework for the development of FHIR implementation guides to facilitate health information exchange. 
• The PACIO Project recommends including the ASHA Functional Communication Measures (FCMs) in the definitions of these data elements to demonstrate the capability in each of these domains for capturing communication specific health information. 
• These data are captured under both Functional Status and Cognitive Status as part of a published FHIR IG titled Personal Functioning and Engagement v 1.0.0, and in another FHIR IG currently in ballot under the same title v 2.0.0, compliant with US Core 6.1.0.

PACIO Support for ICF as an Applicable Vocabulary Standard

• Data Class: Health Status Assessments (V5) 
• Data Element: Mental/Cognitive Status, Functional Status, and Health Concerns (All currently in V5) 
• Recommendation: Add the International Classification of Functioning, Disability and Health (ICF) as an Applicable Vocabulary Standard to these data elements. 
• Rationale: The PACIO (Post-Acute Care Interoperability) Project, established February 2019, is a collaborative effort between industry, government, and other stakeholders, with the goal of establishing a framework for the development of FHIR implementation guides to facilitate health information exchange.  
• The ICF was created by the World Health Organization in 2001 to classify functioning domains as a consequence of health conditions, which are not completely captured by any other codeable concept ontology. This ontology allows users to precisely categorize information on functioning and build in an additional layer of clinical context which is also machine readable. The overarching domains include body structures, body functions, activities and participation, personal factors and environmental factors. 
• The PACIO Project makes extensive use of the ICF ontology in the Personal and Functional Engagement (PFE) FHIR® IG as category codes for clinical observations, health problems, health concerns, and goals. This information captures both clinician insight and in the case of health concerns, allows patients to relate clinical problems to the way they interact with the world in a discrete and machine-readable way. For instance, a patient that has a problem with the structures in their knee might categorize their concern using concepts that describe their ability to play a sport, exercise, navigate their home, or participate in their community, while their rehab team may use concepts related to the functions and structures of the knee, thus building a more complete picture of the problem and why it is important to the patient. 
• The NIH has also created extensive guidance on the use of ICF as a foundation for using Natural Language Processing models to capture free-text functioning information from electronic health records, specifically in the domains relating to mobility, self-care & domestic life, interpersonal interactions and relationships, and communication & cognition. 

NCQA Recommendations for USCDI v6- Smoking Status

Smoking Status: 

Recommendation type: Modification to existing USCDI element.

Recommendation: Update vocabulary standards to include LOINC in addition to SNOMED CT.

Rationale: Smoking behavior details (i.e., pack-years, quit date, smoking duration) included in the definition of the smoking status element are well defined by LOINC. Comprehensive assessment of smoking behaviors remain a public health priority and is essential to understanding a patient’s eligibility for lung cancer screenings, a screening that is recommended by the U.S. Preventive Services Task Force and that remains underutilized despite its proven effectiveness. NCQA is currently developing measures to incentivize appropriate lung cancer screening for those eligible based on smoking history. We leverage both SNOMED CT and LOINC vocabulary standards to define concepts related to current smoking status and smoking history details to determine screening eligibility.

PACIO Comments on Patient Communication Status

• Data Class: Health Status Assessments
• Data Element: Patient Communication Status (currently Level 0)
• Recommendation: Advance Patient Communication Status to USCDI V5 and move it to the Patient Demographics/Information Data Category.
• Rationale: The PACIO (Post-Acute Care Interoperability) Project, established February 2019, is a collaborative effort between industry, government, and other stakeholders, with the goal of establishing a framework for the development of FHIR implementation guides to facilitate health information exchange. The PACIO community applauds the addition of Patient Communication Status to USCDI as a Level 0 data element in draft V5.
• Communication is the active process of exchanging information and ideas. Communication involves both understanding and expression. Forms of expression may include personalized movements, gestures, objects, vocalizations, verbalizations, signs, pictures, symbols, printed words, and output from augmentative and alternative (AAC) devices. When an individual communicates effectively, they are able to express needs, wants, feelings, and preferences that others can understand and can accurately receive messages from others. A person’s ability to comprehend and express information plays a critical role in medical decision making, sharing wishes with caregivers and practitioners, navigating the health care system, patient safety and satisfaction, decreasing diagnostic errors, and shaping the journeys and interactions when transitioning between different health care institutions where one relies heavily on communication skills. Many factors can impact comprehension, including hearing, cognitive and mental status, and functional status of body structures.
• After further examination of this data element, we strongly recommend that a patient’s communication status be included with demographic information. Because this information impacts every encounter within a medical system and how they interact with providers and organizations, and because the underlying causes of an impaired status may be captured under Functional Status and Mental/Cognitive Status, we believe the communication status, unimpaired or impaired and requiring accommodations of any type should be captured with other identifying information.
• Some of this information, specifically spoken language, is already captured in US Core under the Patient Profile with all other demographic information. We believe that this information should be considered as complimentary and captured under demographics using the Communication Status data element.

PACIO Comments on Duplicate Data Elements

• Data Class: Health Status Assessments
• Data Element: Self-care, Mobility, Domestic Life/ Instrumental Activities of Daily Living (IADLs), HHS Disability Status - Activities of Daily Living, HHS Disability Status – Cognitive, HHS Disability Status – Hearing, HHS Disability Status – Independence, HHS Disability Status – Mobility, HHS Disability Status – Vision, Mental Status Evaluation, Mental Health Status (Level 0).
• Recommendation: Remove the Self-care, Mobility, Domestic Life/ Instrumental Activities of Daily Living (IADLs), HHS Disability Status - Activities of Daily Living, HHS Disability Status – Cognitive, HHS Disability Status – Hearing, HHS Disability Status – Independence, HHS Disability Status – Mobility, HHS Disability Status – Vision, Mental Status Evaluation data elements under the Health Status Assessments Data Class in Level 0 and do not consider these data element for inclusion for future versions of USCDI.
• Rationale: The PACIO (Post-Acute Care Interoperability) Project, established February 2019, is a collaborative effort between industry, government, and other stakeholders, with the goal of establishing a framework for the development of FHIR implementation guides to facilitate health information exchange. Conceptually, including these data elements in the USCDI is duplicative, since Functional Status, Mental/Cognitive, and Disability Status were added to USCDI V3 and V4. The data elements of Functional Status and Mental/Cognitive Status are more broadly applicable than these Level 0 data elements, allowing greater flexibility while still enabling exchange of these important clinical concepts. We believe Disability should be captured under patient demographics and have submitted a separate comment reflecting this. We believe guidance around the specific information or content that would satisfy the requirements for exchanging these data elements would be more appropriate to include in the US Core IG and the other standards-based implementation guides.

PACIO Comments on Disability Status

• Data Class: Health Status Assessments 
• Data Elements: Disability Status
• Recommendation: Remove the Disability Status data element from the Health Status data class and instead add a new data element entitled, “Disability” to the patient demographic data class.
• Rationale: The PACIO (Post-Acute Care Interoperability) Project, established February 2019, is a collaborative effort between industry, government, and other stakeholders, with the goal of establishing a framework for the development of FHIR implementation guides to facilitate health information exchange. 
• The PACIO Community supports previous CMS and CDC submissions which reflect their view that identifying a person with a disability does not necessarily have a bearing on how healthy a person is or the status of one’s health. For example, a person’s need to use a mobility aid, like a wheelchair, does not convey any information about why they need that aid or provide any information about their health, only that they use a mobility aid and that they may need mobility accommodations. Information surrounding a disability could be captured under other existing data elements such as Functional Status or Mental/Cognitive Status.
• Collecting and transmitting data on disability, such as presence or need for accommodation, in a standardized way is vital to recognition of disability as a key component of identity and allows analysis of outcomes and conditions in an intersectional way, incorporating race/ethnicity, age, sex, and disability together for a more comprehensive understanding of patient demographics.

Comment

Recommend adding Family History as a data element in either the Health Status Assessment data class or another data class if better suited. Family History is important to capture in order to develop an accurate treatment plan and best care of the patient. Often times, Family History populates in the Problems data class which can cause a clinician to overlook this data element since the clinician expects Family History in a different data class.

NCQA Comment on Smoking Status: for USCDI v5

1. Smoking Status:

NCQA recommends updating the element name to Tobacco-Use Assessment to encompass assessment of broader tobacco products beyond smoked products/cigarettes; This aligns with the FDA definition of Tobacco products. We also recommend adding to the examples of items that fall under this element quit date and smoking duration, in addition to the examples of pack-years and current use already included. We recommend updating the terminology to include LOINC in addition to SNOMED. Smoking status, tobacco-use status, and smoking behavior details (i.e., pack-years) are well defined by LOINC and/or SNOMED. Comprehensive assessment of tobacco-use and smoking behaviors remain a public health priority and are essential to appropriately providing cessation intervention. These data elements are also crucial for understanding a patient’s eligibility for lung cancer screenings, a screening that is recommended by the U.S. Preventive Services Task Force and that remains underutilized despite its proven effectiveness. NCQA is currently developing measures to incentivize routine tobacco use assessments and appropriate lung cancer screening for those eligible based on smoking history.