Comment

Submitted by Lynda S Hoeksema on 2022-04-29

PACIO Update re: data elements under Level 2 Functioning

The PACIO Community (Post-Acute Care Interoperability) leadership wishes to update the ONC/USCDI with current efforts relating to several of the data elements under the USCDI level 2 data class of Functioning (Functional Status, Disability Status, and Mental Function). The PACIO community recognized the value of creating data models (like Gravity’s SDOH) that allow for expansion across multiple domains. As a result, PACIO created a new FHIR Implementation Guide (IG) for the general term “Functional Performance” and will test it at the May 2022 HL7 Connectathon. This IG consolidates PACIO’s prior published IGs (STU1) “Cognitive Status” and “Functional Status”. The PACIO group is also considering adding data elements of communication, swallowing, and hearing to the “Functional Performance” IG currently under development.   Currently the Functional Performance IG data structures focus on observation/assessment data. However, possibilities for future expansion could be considered as the work matures.  The concept of “Functional Performance” encompasses both an individual’s abilities (positive strengths) and disabilities (impairments) across all types of functioning. The PACIO Community examined and incorporated the International Classification of Functioning, Disability and Health (ICF) as a conceptual framework that underpins this new PACIO Functional Performance IG. PACIO’s current work focuses on ICF “Body Functions” including mental functions, sensory functions (including hearing), voice and speech functions, and ingestion functions (swallowing). Current PACIO focus for ICF “Activities and Participation” functions include Learning and Applying Knowledge, Communication, Mobility, and Self-care.

Submitted by aphillips@imoh… on 2022-04-28

Level 2 Data Class: Functioning

While IMO agrees that the exchange of information regarding standardized assessments of patients’ capabilities, conditions, or problems should be included as a Level 2 data class for Functioning in the USCDI, the submission for the proposed Level 2 Data Element for Disability Status does raise some concerns. MO has reservations regarding the technical specification for the Level 2 data element for Disability Status in the Functioning Data Class. The submission does not meet the requirements for a Level 2 Data Element for production implementation or exchange between systems.

Submitted by stevepostal on 2021-09-30

Recommendations to Functioning Data Class

Comment: The American Physical Therapy Association strongly supports the addition of a Functioning Data Class in USCDI Version 3 and submits the following comments: APTA believes that the Functioning data class should reflect the World Health Organization’s International Classification of Functioning, Disability and Health categories and subcategories, located at https://apps.who.int/classifications/icfbrowser/. In 2001, the World Health Assembly approved ICF as a framework for describing and organizing information on functioning and disability. APTA adopted ICF in 2008. As discussed in ICF, functioning is a dynamic interaction between a person’s health condition, environmental factors, and personal factors. Functioning refers to all body functions, activities, and participation, while disability refers to impairments, activity limitations, and participation restrictions. Functioning is what a person with a health condition can do in a standard environment (their level of capacity), such as in a clinic, as well as what they do in their usual environment (their level of performance) such as the home, office, etc. A better way to describe the Functioning data class would be “activities and participation” as described in ICF, specifically, “mobility”; “self-care”; “domestic life”; “major life areas” and “community social and civic life.” The ICF is the framework that has been the main construct of the physical therapy profession that focuses on movement and function of individuals and communities. The ICF concepts are taught in the physical therapy educational programs, are included within licensure exams, and forms the framework that informs current physical therapist clinical practice.  Physical therapists use the concepts of the ICF to evaluate, diagnose and develop individualized plans of care that take into consideration the physical, behavioral, environmental and social determinants of the individual. Multiple studies have demonstrated the strength of ICF as a strong framework for classifying functioning and disability. ICF has been described as the “gold standard for collecting and analyzing functioning information in rehabilitation.”[1] It provides a unified, standard language, and framework that enables the collection of data for practice and research — language that describes how people function in their daily lives rather than focusing exclusively on their medical or disease-specific diagnosis. The universality of the ICF language and framework permits a shared conceptual understanding of health, bridging disciplines, sectors, cultures, and geographic regions. ICF assists in adding “structure to the description and understanding of physical functioning-related domains in acute care settings.”[2] One study referred to ICF as “an essential tool for identifying and measuring efficacy and effectiveness of rehabilitation services, both through functional profiling and intervention targeting,” and that “[t]he ICF, in short, offers an international, scientific tool for understanding human functioning and disability for clinical, research, policy development and a range of other public health uses.”[3] APTA has long endorsed ICF and uses it to develop evidence-based practice guidelines that will enhance diagnosis, intervention, prognosis, and assessment of outcomes for a variety of musculoskeletal conditions. APTA has produced 17 clinical practice guidelines based on ICF, including: Low Back Pain (https://www.jospt.org/doi/10.2519/jospt.2012.42.4.A1), authored by the Orthopaedic Section of APTA (April 2012).   Speaking on behalf of its 100,000 member physical therapists, physical therapist assistants, and students of physical therapy who are actively involved in providing care to individuals, APTA recommends ONC to incorporate the following into USCDI Version 3 based on ICF:
  • Elaborating on the naming of the “Functioning” data class to model subcategories within the “Activities and Participation” category of ICF, specifically: “mobility”; “self-care”; “domestic life”; “major life areas”; and “community social and civic life.”
  • Advance the functioning data class from the “Comment” level to “Level 2” in USCDI version 3. As shown below, ONC should elevate the “Functioning” data class from “Comment” to “Level 2” based on overall value of the data elements and broad use of activities and participation data information by the community.
Prioritize and encourage the advancement of high priority data classes and elements, specifically separating data classes and elements that are associated with “functional status/limitation” from those associated with “disability status,” as suggested in
  • Recommendation #3 of the USCDI Task Force 2021’s Phase 3 Recommendations on ONC Priorities for the USCDI v3 Submission Cycle.
Mobility encompasses changing and maintaining body position, carrying, moving, and handling objects, and walking and moving, among others. Self-care encompasses washing oneself, toileting, dressing, and eating, among others. Domestic life encompasses household tasks and caring for household objects and assisting other people, among others. If there are impediments to a person’s function, such as the inability to walk, lift, and carry due to a health condition (e.g., an injury or illness) or a barrier (such as stairs for a person with weakness in the legs), the person may be unable to perform routine tasks such as shopping to get food, picking his/her child up from the crib, driving a car, etc. Functioning impairments like the inability to walk or the increased effort required to move from one place to another can lead to sedentary lifestyle behaviors such as lack of exercise, decreased movement, or contractures in joints, which in turn can lead to obesity, elevated blood pressure, and other more serious health conditions. Prevention of these secondary complications is key to ensuring patients’ health and well-being. Functioning is pervasive across all aspects of care, and as such, other health care providers depend upon physical therapists to relay information about patient functioning; it is relied upon when making determinations about whether a patient can be safely discharged to their home/community or whether additional care is more appropriate, for example. Functioning is also important for socialization and participation in society such as employment, going to school, or attending religious activities. Disruption to a person’s functioning or the inability to function can lead to social isolation and strained personal relationships. APTA conducted an informal survey in February 2021 seeking information from physical therapists regarding documentation of functioning and how information on functioning is shared with other providers. We received feedback from more than 200 organizations across the continuum of care:
  • Large health systems (four).
  • University outpatient system (four locations).
  • Rehab agency (one).
  • Home health agency (one).
  • Rehabilitation contract therapy company (one) that works with skilled nursing facilities and home health agencies.
  • Physical therapist private practices (urban and rural), including:
    • 200+ companies representing 650 locations and 2,650 providers.
    • One company with 500+ locations.
As outlined in detail below, the most common subdomains of functioning captured within EHR systems across settings are mobility and self-care. This information about functioning is consistently being shared among providers and across health care settings as well as with patients. Every provider indicated that their EHR system allows them to capture information on function. EHRs used by these providers include but are not limited to:
  • A2C.
  • Athena Health.
  • Cadurx.
  • Caretracker.
  • Cerner.
  • Clinicient.
  • Clinic Controller.
  • Epic.
  • Fusion WebClinic.
  • Gentiva.
  • HomeCare HomeBase.
  • NextGen.
  • Office Ally.
  • RainTree.
  • WebPT.
As listed below, functioning is documented in a variety of ways across these EHRs:
  1. General text.
  2. Discrete data (rolling, sitting, transfer from supine to sit).
  3. Subcategories (mobility, self-care) and general text.
  4. General text and subcategories.
  5. General text; subcategories (mobility, self-care, etc.); free text; and discrete data.
  6.  Results of reliable and valid tests and measures such as performance-based measures or patient reported outcome measures.
All providers surveyed reported that they share information on functioning with providers outside of their organization, although the method of communicating information on patient functioning to other providers varies. While small practices reported difficulties in sharing information in a standardized format, large practices and large health systems are sharing it consistently using data standards like direct messaging, C-CDA Level 1, and C-CDA Level 3 documentation. Mechanisms for sharing such information include:
  • Send records using data standards (C-CDA Level 1, Level 3).
  • Allscripts.
  • Direct messaging.
  • Secure portals.
  • Print and fax records.
  • Print the entire note and send to another provider in a HIPAA-compliant fashion.
  • Secure email with PDF.
As demonstrated above, information on functioning is broadly collected, used, and exchanged in different settings and within different EHR systems. It is collected upon evaluation and is relied upon to inform the plan of care; functioning is documented within each treatment note, progress report, and upon discharge. Clearly, patient functioning pertains to most or all patients and is relevant to all providers who care for all patients, such as those with diagnoses within medical, surgical, and primary care. The elevation of the functioning data class to Level 2 status within USCDI and a uniform standardization based upon ICF would help EHR communities better understand the direction that ONC is moving toward and the importance of sharing aspects of functioning and the importance of function for all individuals.   In conclusion, APTA urges ONC to incorporate the following into USCDI Version 3:
  • Elaborating on the naming of the “Functioning” data class to model subcategories within the “Activities and Participation” category of ICF, specifically: “mobility”; “self-care”; “domestic life”; “major life areas” and “community social and civic life.”
  • Advance the functioning data class from the “Comment” level to “Level 2” in USCDI version 3.
  • Prioritize and encourage the advancement of high priority data classes and elements, specifically separating data classes and elements that are associated with “functional status/limitation” from those associated with “disability status.”
  [1]Clinical Implementation of ICF-based Functioning Information as Outcomes in Rehabilitation. Available at: https://www.frontiersin.org/research-topics/17568/clinical-implementation-of-icf-based-functioning-information-as-outcomes-in-rehabilitation. [2]González-Seguel P, et al. International Classification of Functioning, Disability, and Health Domains of 60 Physical Functioning Measurement Instruments Used During the Adult Intensive Care Unit Stay: A Scoping Review. Phys Ther. 2019;99(5):627–640. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6517362/. [3] Üstun TB. The International Classification of Functioning, Disability and Health: a new tool for understanding disability and health. Disabil Rehabil. 2003;25(11-12):565–571. Available at:  https://pubmed.ncbi.nlm.nih.gov/12959329.

Submitted by dvreeman on 2021-09-30

CMS Data Element Library Health IT Workgroup Recommendation

Comments on behalf of the CMS Data Element Library (DEL) Health IT Workgroup:  Since our Fall 2020 submission of the Functioning Data Class and constituent Data Elements (Domestic Life/IADLs, Mental Function, Mobility, and Self-Care), several groups have recommended that ONC prioritize functioning content within USCDI, including: The APTA has provided ONC with extensive documentation of the extent to which functional abilities and disabilities (e.g. impairments in body function or structure, activity limitations, and restrictions in an individual's involvement in life situations) are documented and shared in the current ecosystem. WHO has now incorporated specific functioning content into ICD-11 and enabled its joint use with the International Classification of Functioning, Disability and Health (ICF), with the intent of facilitating activities such as evaluation for general medical practice (e.g. fitness for work), evaluation for social benefits (e.g. disability, pension), and needs assessment (e.g. for rehabilitation, occupational assistance, long term care.) The ICF is the preeminent biopsychosocial model of functioning and disability. According to the CDC, 26% of adults in the U.S. experience disability. Because people with disabilities (such as mobility limitations, intellectual disabilities, etc) face greater barriers to achieving optimal health and accessing health care[PMID: 30114005], interoperable exchange of functioning data is crucial for addressing health inequities (as emphasized by CDC, National Center on Health, Physical Activity and Disability, and many other organizations). We strongly recommend that ONC promote Functioning content into the USCDI. In this regard, the most pressing gap in USCDI is representation of Functioning observations. Observations are characteristics that can be tested, measured, observed, or reported and are communicated with a name-value pair structure. Aligned with the ICF framework, we recommend including mental functioning (what some may refer to as cognitive status) observations within this broad data class. We make this recommendation not only because they share the same data structure, but also because, as ICF illustrates, impairments in body functions (such as mental functioning and/or movement-related functions) can influence one's ability to perform activities such as IADLs. Consistent with the HITAC recommendation (USCDI-TF-2021-Phase 3_Recommendation 07), we propose that Functioning be added as a subcategory (profile) of a more general Observation structure so that it can inherit (and share) the same data elements (attributes) as other similar data (e.g. Observation.code, Observation.value, Observation.performer). This structure has been demonstrated to carry LOINC-code observations about mobility, self-care, cognition, and other key domains from the CMS-required assessment instruments used in post acute care via the PACIO project (http://pacioproject.org/). 

Submitted by sg999 on 2021-09-28

CMS-CCSQ support for Functioning Data Class in USCDI V3

CMS-CCSQ is interested in advancing the capture of data related to disability status is critical for care. Exchange of this information nationwide fosters management of patients with disability to ensure all receive appropriate care. We recommend ONC support the exchange of disability status data via the USCDI. Disability status can be captured in standardized fields related to existing data elements in USCDI: Problems, Devices Used, and via the proposed USCDI data class, Functioning. FHIR allows for concepts related to disability data to be exchanged in many standardized formats, including the patient profile disability status extension in QI Core IG, and via LOINC and SNOMED terminology (i.e., Disability Status value set (OID: 2.16.840.1.113762.1.4.1099.49)). This allows for flexibility in the definition of disability used across use cases (e.g., defining disability using frailty and/or functional status vs. defining disability based on qualifying status for disability programs, such as social security), while still allowing for data capture and exchange to occur in a standardized fashion. We recommend ONC add the Functioning data class to the USCDI to support exchange of this critical information and discussion around exchanging disability status information via USCDI data classes and elements.

Submitted by tomalley on 2021-04-15

Advance Functioning Data Class to Level 2

Functional status is a serious omission from USCDI.  It is a significant predictor of readmissions (Shih, S.L., Gerrard, P., Goldstein, R. et al. Functional Status Outperforms Comorbidities in Predicting Acute Care Readmissions in Medically Complex Patients. J GEN INTERN MED 30, 1688–1695 (2015). https://doi.org/10.1007/s11606-015-3350-2), length of stay (Huggan PJ, Akram F, Er BH, Christen LS, Weixian L, Lim V, Huang Y, Merchant RA. Measures of acute physiology, comorbidity and functional status to differentiate illness severity and length of stay among acute general medical admissions: a prospective cohort study. Intern Med J. 2015 Jul;45(7):732-40. doi: 10.1111/imj.12795. PMID: 25944281), and death (Formiga F, Ferrer A, Padros G, Montero A, Gimenez-Argente C, Corbella X. Evidence of functional declining and global comorbidity measured at baseline proved to be the strongest predictors for long-term death in elderly community residents aged 85 years: a 5-year follow-up evaluation, the OCTABAIX study. Clin Interv Aging. 2016 Apr 18;11:437-44. doi: 10.2147/CIA.S101447. PMID: 27143867; PMCID: PMC4841391). As noted in several other comments, there are elements of functional assessment and associated vocabularies currently in wide use.  As an example, the CMS Data Element Library (DEL) contains the data elements used in the federally mandated assessment instruments across all post-acute care settings. All DEL elements have associated LOINC codes; and they are currently being mapped to C-CDA templates. The PACIO Project is focusing on both functional status and cognition elements within the DEL to establish FHIR resources. Function is so important that it needs a placeholder in USCDIv2 even if it is incomplete. It would be reasonable to add a “Functioning” data class to USCDIv2 and initially populate it only with the functional status data elements from the DEL that have LOINC codes and that are mapped to C-CDA templates.  Although incomplete, it would be a start. Additional assessment instruments, data elements and subcategories of function can be added in subsequent versions.   

Submitted by Kara Rose on 2021-03-17

Advance Functioning Data Class to Level 2

On behalf of the American Physical Therapy Association, please find below our comments outlining the rationale and evidence to support why the data class of "Functioning" should be moved from “Comment” to “Level 2,” based on overall value of the data elements, the maturity of terminology standards used, and broad implementation by the community. In 2001, the World Health Assembly approved the International Classification of Functioning, Disability and Health (ICF) as a framework for describing and organizing information on functioning and disability. As discussed in the ICF, functioning is a dynamic interaction between a person’s health condition, environmental factors, and personal factors. Functioning refers to all body functions, activities, and participation, while disability refers to impairments, activity limitations, and participation restrictions. Functioning is what a person with a health condition can do in a standard environment (their level of capacity) such as in a clinic, as well as what they do in their usual environment (their level of performance) such as the home, office, etc. Functioning includes actions and tasks executed by individuals (activities) and involvement in life situations (participation). Functioning within a person’s environment is important for daily life activities, such as bathing, toileting, and making meals; it also is important for socialization and participation in society such as working, going to school, or attending religious activities. If there are barriers to a person’s function, such as the inability to walk, lift, and carry due to a health condition (e.g., an injury or illness) or a barrier (such as stairs for a person with weakness in the legs), the person may be unable to perform routine tasks such as shopping to get food, picking his/her child up from the crib, driving a car, etc. Disruption to a person’s functioning or the inability to function can cause multiple complications ranging from additional medical conditions, to physical and social isolation, to strained personal relationships. For example, the inability to walk or the increased effort required to move from one place to another can lead to sedentary lifestyle behaviors such as lack of exercise, decreased movement, or contractures in joints, which in turn can lead to obesity, elevated blood pressure, and other more serious health conditions. Prevention of these secondary complications is key to ensuring patients' health and wellbeing. Functioning is pervasive across all aspects of care, and as such, other health care providers depend upon physical therapists to relay information about patient functioning; it is relied upon when making determinations about whether a patient can be discharged to their home/community or whether additional care is more appropriate, for example. APTA conducted an informal survey in February 2021 seeking information from physical therapists regarding documentation of functioning and how information on functioning is shared with other providers. We received feedback from more than 200 organizations across the continuum of care:
  • Large health systems (4)
  • University outpatient system (4 locations)
  • Rehab agency (1)
  • Home health agency (1)
  • Rehabilitation contract therapy company (1) that works with skilled nursing facilities and home health agencies
  • Physical therapist private practices (urban and rural), including:
    • 200+ companies representing 650 locations and 2,650 providers
    • 1 company with 500+ locations
As outlined in detail below, the most common subdomains of functioning captured within EHR systems across settings is mobility and self-care. This information about functioning is consistently being shared among providers and across health care settings as well as with patients. Every provider indicated that their EHR system allows them to capture information on function. EHRs utilized by these providers include:
  • A2C
  • Athena Health
  • Cadurx
  • Caretracker
  • Casamba
  • Cerner
  • Clinicient
  • Clinic Controller
  • Epic
  • Fusion WebClinic
  • Gentiva
  • HomeCare HomeBase
  • NextGen
  • Office Ally
  • RainTree
  • WebPT
As listed below, functioning is documented in a variety of ways across these EHRs:
  1. General text
  2. Discrete data (rolling, sitting, transfer from supine to sit)
  3. Sub-categories (mobility, self-care) and general text
  4. General text and sub-categories
  5. General text; sub-categories (mobility, self-care, etc.); free text; and discrete data
All providers surveyed reported that they share information on functioning with providers outside of their organization, although the method of communicating information on patient functioning to other providers varies. While small practices reported difficulties in sharing information in a standardized format, large practices and large health systems are sharing it consistently using data standards like direct messaging, C-CDA Level 1, and C-CDA Level 3 documentation. Mechanisms for sharing such information include:
  • Send records using data standards (C-CDA Level 1, Level 3)
  • AllScripts
  • Direct messaging
  • Secure portals
  • Print and fax records
  • Print the entire note and send to another provider in a HIPAA-compliant fashion
  • Secure email with PDF
As demonstrated above, information on functioning is broadly collected, used, and exchanged in different settings and within different EHR systems. It is collected upon evaluation and is relied upon to inform the plan of care; functioning is documented within each treatment note, progress report, and upon discharge. Clearly, patient functioning pertains to most or all patients and is relevant to all providers who care for such patients, including oncology, cardiology, primary care, and public health. Moreover, the inclusion of the functioning data class within the USCDI would help EHR communities better understand the direction that ONC is moving towards and the importance of sharing aspects of functioning. APTA also supports data elements within the Functioning data class that rely on the conceptual framework of ICF. Therefore, APTA recommends that ONC advance the functioning data class from the “Comment” level to at least “Level 2” to ensure consideration for inclusion in a future version of the USCDI.

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