Assessments of a health-related matter of interest, importance, or worry to a patient, patient’s family, or patient’s healthcare provider that could identify a need, problem, or condition.
Assessment of a patient's level of cognitive functioning. (e.g., alertness, orientation, comprehension, concentration, and immediate memory for simple commands)
Applicable Vocabulary Standard(s)
Applicable Standards
Logical Observation Identifiers Names and Codes (LOINC®) version 2.72
Submitted By: Michelle Dougherty
/ Submitted on behalf of the CMS Data Element Library (DEL) Health IT Workgroup
Data Element Information
Use Case Description(s)
Use Case Description
Exchange of Data for Transitions of Care and Care Coordination:
Data exchange between acute care, post-acute care (PAC) providers, the patient and caregivers, and other care settings (physician practices, community based services, etc.), using common standards and definitions, supports patient-centered care by providing access to longitudinal information at transition and facilitating care coordination. An ASPE and CMS study found that 45% of Medicare patients required PAC services after an acute hospital stay.* The importance of exchanging data elements related to functioning at transition of care is described in the findings of the 2020 national study on hospital adoption of electronic health record functionality to support age-friendly care.** It concluded that US acute care hospital EHRs lack key features and health information exchange of important information that supports care for older adults, including structured documentation on mentation and mobility. Emerging work on frailty indices have found relationships between poor physical functioning and risk of adverse health outcomes.*** An ASPE funded project is currently exploring how health systems may use EHR-based data for frailty algorithms, including aspects of frailty related to mobility and cognitive limitations. Having functional limitations does not necessarily mean that a person is frail. Widespread exchange of the content specified in this data class (and corresponding data elements) proposal has the potential to improve patient and provider communications and supports access to longitudinal information that enables improved efficiencies, improved quality of care, and improved health outcomes.
The 2014 Improving Medicare Post-Acute Care Transformation (IMPACT) Act required the standardization and interoperability of specific categories of PAC patient assessment content, including the content applicable to the proposed data elements. For PAC settings including SNFs, HHAs, and specialty hospitals (inpatient rehabilitation facilities (IRFs), long term care hospitals (LTCH)), standardized patient assessment data reported to the Centers for Medicare and Medicaid Services (CMS) includes items about mental function, mobility, self-care and domestic life/IADLs that represented as observations. All of these concepts are represented in LOINC. The conceptual framework of the International Classification of Functioning (ICF) informed the development of these and other functioning data elements. Prior to use on the patient assessment, these data elements were tested for validity and reliability and are used for quality measurement, payment, public reporting and oversight.
Representation of functioning observations is well supported by all of the common exchange paradigms, including messages, documents, and APIs. Here we highlight the two most prevalent.
• FHIR: The HL7 PACIO project is focused on advancing interoperable health data exchange between PAC and other providers, patients, and key stakeholders across health care. The project has developed a FHIR Functional Status Implementation Guide and a FHIR Cognitive Status Implementation Guide (IG) which will be balloted as a standard for trial use in October 2020. The IG leverages the FHIR exchange structures and LOINC-coded observations. Successful exchange of functioning data from PAC assessments using the PACIO IGs was demonstrated in the January, May, and September 2020 Connectathons. PAC assessment data about mental function, mobility, self-care, and domestic life/IADLs are also included in use cases for the eLTSS and Care Plan HL7 FHIR projects.
• C-CDA: This data class and data elements are aligned with C-CDA templates for mental status and functional status. Functioning information from SNF and HHA patient assessments are being exchanged with HIEs and other providers using HL7 C-CDA. This exchange is supported by select EHR vendors, VorroConnect KeyHIE Transform, and the 360X data exchange initiative.
Sources:
*RTI International analysis of 2014 Medicare claims under contract with the Assistant secretary for Planning and Evaluation, August 2018, unpublished
**Hospital adoption of electronic health record functions to support age-friendly care: results from a national study. JAMIA 08/2020. https://pubmed.ncbi.nlm.nih.gov/32772089/
*** Validation of a Claims-Based Frailty Index Against Physician Performance and Adverse Health Outcomes in Health and Retirement Study. J Gerontol A Biol Sci Med Sci, 2019, Vol. 74, No. 8, 1271–1276
- VorroConnect: https://vorroconnect.com/products/healthcare-information-exchange/
- 360X: https://oncprojectracking.healthit.gov/wiki/display/TechLab360X/360X+Home
Estimate the breadth of applicability of the use case(s) for this data element
Stakeholder estimates can be challenging since the proposed data elements should be usable across the continuum of care, and beyond the traditional healthcare system – into the community. We know that PAC providers are required to collect standardized and interoperable data elements related to functioning at patient admission, discharge, and specified time intervals using defined CMS assessments. However, standardized capture of data elements related to functioning is inconsistent in other healthcare settings such as acute care hospitals and primary care/specialty care physician practices.
In attempting to quantify stakeholders potentially involved in the use and exchange of data elements related to functioning, we relied on the July 2020 CMS Fast Facts to provide a picture of both providers and patients (i.e., beneficiaries), albeit from a Medicare perspective. While the numbers that appear below are significant, it is important to remember that they are constrained to Medicare providers and persons served who are covered by original Medicare. Non-Medicare providers and patients who are not covered by original Medicare (e.g., Medicaid only, privately insured, etc.) are not reflected in the counts but would still be stakeholders for the proposed data elements. It is also important to note that caregivers and providers of long term supports and services (e.g., home health aides, meals on wheels) are increasingly recognized as important stakeholders in health information exchange but are also not reflected in the metrics below.
Institutional Medicare Providers (for 2019) & Persons Served (original Medicare for 2018)
• Inpatient Hospitals - 6,023 providers; 6.5 million persons served
• SNFs - 15,103 providers; 1.7 million persons served
• HHAs – 11,157 providers; 3.6 million persons served (Medicare Part A skilled and Medicare Part B non-skilled services)
Notes:
• The CMS Fast Facts reports include the 306 IRF providers and 367 LTCH providers, who are subject to CMS PAC assessment provisions, in the “inpatient hospital” counts for both providers and persons served. There is no setting specific count of persons served for these IRF and LTCH providers.
• Other types of Medicare Institutional providers were identified that would be stakeholders for data elements related to functioning, but for which separate counts of persons served were not available. There were 21,000+ providers identified as outpatient physical therapy/speech pathology, rural health clinics, federally qualified health centers, comprehensive outpatient rehab facilities, or hospice providers.
Non-institutional Medicare Providers (for 2019)
• Primary care, surgical specialties, medical specialties, and psychiatry – 537,390 providers
• Non-physician practitioners – 489,765 providers
Note:
• The non-physician practitioner classification (e.g., nurse practitioners, physician assistants) does not provide sufficient detail to discern the numbers of these practitioners associated with the targeted primary care and specialty providers.
Support Quality Measures:
Standardized and interoperable PAC functioning data elements have the potential to be utilized to support clinical quality measures (CQMs) in a variety of existing quality reporting programs and future digital quality measures.
• Mental Status: As cognitive function can impact patient safety, as well as overall physical functioning, the data elements could be used for a quality measure that is focused specifically on cognition but may also be relevant to the construct of other eCQMs. Currently, CMS149v8, Dementia: Cognitive Assessment, has been validated for use with nursing home patients only using the Minimum Data Set (MDS) Brief Interview of Mental Status (BIMS).
• Mobility, Self-care, Domestic Life/IADLs: Dependence on others for ADL assistance can lead patient’s to feelings of helplessness, isolation, diminished self-worth, and loss of control over one’s destiny. As inactivity increases, complications such as pressure ulcers, falls, contractures, depression, and muscle wasting may occur.
• Functioning data elements could be used for a quality measure that is focused specifically on this data element (e.g., MIPS CQM #282: Dementia: Functional Status Assessment), and may also be relevant to the construct of other eCQMs. The Clinical Reasoning and PACIO FHIR initiatives have used PAC data in the May and September 2020 Connectathon demonstrations of CMS149 and CMS104.
Currently, there are six NQF endorsed measures that address concepts of functioning (NQF #2631 thru 2636) and use standardized data elements related to functioning from PAC assessments. One or more of these NQF measures are a component of the CMS Quality Reporting Programs (QRPs) for SNFs, IRFs, LTCHs, and HHAs. Additionally, data related to functioning are used in quality measures that help inform facility ratings in the Five Star Quality Rating System whose results are made available on CMS public reporting websites.
Estimate the breadth of applicability of the use case(s) for this data element
Stakeholder estimates can be challenging since the proposed data elements should be usable across the continuum of care, and beyond the traditional healthcare system – into the community. We know that PAC providers are required to collect standardized and interoperable data elements related to functioning at patient admission, discharge, and specified time intervals using defined CMS assessments. However, standardized capture of data elements related to functioning is inconsistent in other healthcare settings such as acute care hospitals and primary care/specialty care physician practices.
In attempting to quantify stakeholders potentially involved in the use and exchange of data elements related to functioning, we relied on the July 2020 CMS Fast Facts to provide a picture of both providers and patients (i.e., beneficiaries), albeit from a Medicare perspective. While the numbers that appear below are significant, it is important to remember that they are constrained to Medicare providers and original Medicare persons served. Non-Medicare providers and patients who are not covered by original Medicare (e.g., Medicaid only, privately insured, etc.) are not reflected in the counts but would still be stakeholders for the proposed data elements. It is also important to note that caregivers and providers of long term supports and services (e.g., home health aides, meals on wheels) are increasingly recognized as important stakeholders in health information exchange but are also not reflected in the metrics below.
Institutional Medicare Providers (for 2019) & Persons Served (original Medicare for 2018)
• Inpatient Hospitals - 6,023 providers; 6.5 million persons served
• SNFs - 15,103 providers; 1.7 million persons served
• HHAs – 11,157 providers; 3.6 million persons served (Medicare Part A skilled and Medicare Part B non-skilled services)
Notes:
• The CMS Fast Facts reports include the 306 IRF providers and 367 LTCH providers, who are subject to CMS PAC assessment provisions, in the “inpatient hospital” counts for both providers and persons served. There is no separate count of persons served for these IRF and LTCH providers.
• Other types of Medicare Institutional providers were identified that would be stakeholders for data elements related to functioning, but for which separate counts of persons served were not available. There were a were 21,000+ providers identified as outpatient physical therapy/speech pathology, rural health clinics, federally qualified health centers, comprehensive outpatient rehab facilities, or hospice providers.
Non-institutional Medicare Providers (for 2019)
• Primary care, surgical specialties, medical specialties, and psychiatry – 537,390 providers
• Non-physician practitioners – 489,765 providers
Note:
• The non-physician practitioner classification (e.g., nurse practitioners, physician assistants) does not provide sufficient detail to discern the numbers of these practitioners associated with the targeted primary care and specialty providers.
Improving patient experience of care (quality and/or satisfaction)
Improving the health of populations
Reducing the cost of care
Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s)
LOINC.
LOINC is a freely available global standard that contains a well-developed model for representing variables, answer lists, and the collections that contain them.* Many clinical assessments, scales, and other observations related to functioning are present in LOINC, including all of the variables on the PAC assessments for SNFs, IRFs, LTCHs, and HHAs. Regenstrief operates a robust process for adding new content (including functioning assessment instruments) if key gaps are identified.
*PMID: 22899966
PACIO Project: FHIR Cognitive Status Implementation Guide (STU ballot scheduled for October 2020)
PACIO Project: FHIR Functional Status Implementation Guide (STU ballot scheduled for October 2020)
Current Use
In limited use in test environments only
Extent of exchange
N/A
Potential Challenges
Restrictions on Standardization (e.g. proprietary code)
We are not aware of restrictions on standardization of proposed data elements in PAC settings. However, we are not aware of standardization of these proposed data elements in other care settings such as acute care hospitals, physician practices, etc.
Restrictions on Use (e.g. licensing, user fees)
Intellectual property issues related to use of the BIMS, CAM, and PHQ2/PHQ9 in PAC assessments have been addressed through appropriate annotations on printed and electronic representation of these items. as proposed data elements have not been standardized in acute care settings, assessments of functioning used in these settings would need to be evaluated for intellectual property considerations.
Privacy and Security Concerns
This data should be exchanged securely. Secure data transfer process as governed by CMS and ONC should be followed
Estimate of Overall Burden
PAC settings such as SNFs, IRFs, LTCH, and HHAs, are required to report standardized patient assessment data to CMS for purposes of Medicare payment, quality reporting, and compliance surveys. These patient assessments include concepts of mental function, mobility, self-care and domestic life/IADLs.
Outside of the post-acute care settings, these data elements may not be structured and are not captured with consistency.
Other Implementation Challenges
For PAC settings, the proposed data elements are collected from standardized assessments and reported to CMS using agency specific data submission protocols and specifications. However, as PAC providers are excluded from EHR certification requirements, there is significant variance in the adoption of interoperability terminologies and exchange standards by EHR vendors supporting post-acute care settings. Additionally, while some providers may capture mental status, mobility, self-care and/or domestic life/IADL data in acute care or outpatient settings, they may use other instruments (observations) to capture this data.
HL7 recommends that Depression Assessment listed under Health Status Assessment as an example screening of interest, recognizing that not all health information technology (HIT) may need to support that when being certified. Depressive disorders are common mental disorders that occur in people of all ages. Major depressive disorder (MDD) is the second leading cause of disability worldwide, affecting an estimated 120 million people. Depression has a large effect on health care costs and on productivity. Adolescents with depression have higher medical expenditures, including those related to general and mental health care, than adolescents without depression. For working-adults, one study showed a relationship between the severity of depression symptoms and work function and found that for every 1-point increase in a Patient Health Questionnaire 9 (PHQ-9) score (a measure of depression severity); patients experienced an additional mean productivity loss of 1.65%. Even minor levels of depression symptoms were associated with decreases in work function. The U.S. Preventive Services Task Force (USPSTF) recommends screening for depression among adolescents 12-18 years and the general adult population, including pregnant and postpartum women.
Health Status – Mental Function / Mental Health Status and Cognitive Status
NACHC supports the separation of the current "Mental/Cognitive Status" element into two distinct components: "Mental Health Status" and "Cognitive Status". While these elements naturally fall under the broader category of "Health Status Assessment", it is crucial to recognize their unique clinical nature and definitions. "Cognitive Status" is assessed using established measures like MoCA, SLUMS, or MMSE, evaluating orientation, attention, memory, judgment, and reasoning. In contrast, "Mental Health Status" encompasses diagnoses such as depression, anxiety, and ADHD, and is evaluated using validated assessments like PHQ-9, GAD-7, and the Vanderbilt Assessment Scale. NACHC encourages ONC to support work on a list of preferred instruments and mappings that will assist organizations in normalizing these types of data.
The urgency of this matter is underscored by staggering statistics from the Centers for Disease Control and Prevention (CDC). Over 50% of individuals in the United States will receive a mental health diagnosis in their lifetime, with more than 57 million annual visits to physician offices where mental disorders are the primary diagnosis. Additionally, the U.S. Preventive Services Task Force (USPSTF) has recommended depression screening for various populations since 2016, extending to adolescents, children, and pregnant or postpartum women as of 2022.
Furthermore, the National Committee for Quality Assurance (NCQA) places a high priority on the diagnosis of depression due to its well-documented impact on physical health, mental health, and functional status. This commitment led to the development of five depression care measures within the Healthcare Effectiveness Data and Information Set (HEDIS), notably focusing on the PHQ-9 assessment tool.
We believe that implementing these recommendations will significantly enhance the comprehensive assessment of mental health, leading to more effective care and improved patient outcomes.
Data Elements: Functional Status, Mental/Cognitive Status, Disability Status (Draft V4)
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 CMS and CDC submission, which reflect their view that identifying a person with a disability does not necessarily have any bearing on how healthy a person is or the status of one’s health. However, collecting and transmitting data on disability in a standardized way alongside other demographic factors 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.
Data Elements: Functional Status, Mental/Cognitive Status, Disability Status (Draft V4)
Recommendation: Adopt the value sets developed for the “Personal Functioning and Engagement” IG as part of the USCDI V3 updates to the U.S. Core IG to incorporate Functional Status and Cognitive Status 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. Functional and Mental/Cognitive Status are important data classes that have widespread use in all healthcare settings and sharing the content of standardized PAC assessments (some of which are federally required) with non-PAC providers (e.g., hospitals, physicians) would improve the quality of care and facilitate care coordination during transitions of care. These instruments use a consistent framework mapped to HIT standards for functional status, contain administrative and clinical patient data, can be considered as individual data elements (mobility, pressure ulcer, transportation, social isolation, etc.) or a “questionnaire” of grouped data elements together (MDS, OASIS, IRFPAI, FASI etc.) The PACIO Community wishes to update the ONC/USCDI with current efforts relating to several of the data elements under the proposed USCDI V4 data class of Health Status (Health Concerns, Functional Status, Disability Status, and Mental/Cognitive Status). 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), “Personal Functioning and Engagement,” which consolidates PACIO’s prior published IGs (STU1) “Cognitive Status” and “Functional Status”. The PACIO group also is incorporating data elements of communication, swallowing, and hearing to the “Personal Functioning and Engagement” IG currently under development. Currently, the Personal Functioning and Engagement IG data structures focus on observation/ assessment data. However, the IG could include future expansion using additional resources as the work matures. The concept of “Personal Functioning and Engagement” 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 Personal Functioning and Engagement 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.
In the USCDI v.3, the definition of Cognitive Status does not mention worsening/better whereas the functioning definition does. The current definition of Functional Status (“Assessment of a patient’s capabilities, or their risks of development or worsening of a condition or problem. (e.g., fall risk, pressure ulcer risk, alcohol use)" is includes the capabilities (positive aspect of functioning) and the risk for worsening (negative aspect of functioning). This may be confusing to the user.
The PACIO Community recommends the adoption of the International Classification of Functioning, Disability, and Health (ICF) conceptualization of functioning. The ICF defines functioning as the positive or neutral aspects of the interrelationships of the person, their health condition, and contextual factors (personal and environmental factors). This definition would provide a uniform approach to the definitions of disability and functional status. In addition, if adopting the ICF framework, Functional Status and Cognitive Status would consider positive or neutral aspects of their domain as the definition of both use the term “functioning.” However, if ONC retains the existing definition of functioning, for consistency, the PACIO Community recommends including worsening/better in the Cognitive Status definition for USCDI v.4.
To maximize the utility of the data exchanged during transitions of care, the PACIO Community recommends including the questions and answers, expressed using LOINC, for the Functional and Mental/Cognitive Status data elements that are part of the federally required PAC assessment instruments, not just what functional or Mental/Cognitive assessment was performed.
The American Occupational Therapy Association supports and appreciates the inclusion of mental functions in the health status data class. AOTA participates in the PACIO Project work on the Cognitive Status Implementation Guide that has since been renamed to Functional Performance. Developing an interoperable and interdisciplinary method of collecting information on an individual's mental functions is crucial in early detection of cognitive decline, onset of delirium, or identification of trends over time. AOTA encourages ONC to consider how this data can be efficiently and accurately collected beyond admission and discharge and how data from other clinicians, such as occupational therapy practitioners, can be utilized in this data class.
NACHC is supportive of the concept of mental function; however, it is not likely to support interoperability to solely create a terminology binding to support the concept. Because the concepts in the draft version generally represent non-semantically equivalent types of cognitive function and observations about these conditions, we believe that creating a class for this concept will likely create larger transitions of care documents without being able to be processed by receiving systems.
Furthermore, there will likely be confusion between which assessments constitute “Functional Status” and “Mental Function”. Would recommend renaming this term. This approach creates liability for providers who at best can use this data as free text in this case and contributes to data overload and burnout.
We strongly recommend providing either specific categories of functional status with equivalent semantics and clear terminology bindings.
Submitted by nachcinformatics on
Depression Assessment
Health Status Assessments: Mental/Cognitive Status
https://www.healthit.gov/isa/taxonomy/term/1616/draft-uscdi-v5
HL7 recommends that Depression Assessment listed under Health Status Assessment as an example screening of interest, recognizing that not all health information technology (HIT) may need to support that when being certified. Depressive disorders are common mental disorders that occur in people of all ages. Major depressive disorder (MDD) is the second leading cause of disability worldwide, affecting an estimated 120 million people. Depression has a large effect on health care costs and on productivity. Adolescents with depression have higher medical expenditures, including those related to general and mental health care, than adolescents without depression. For working-adults, one study showed a relationship between the severity of depression symptoms and work function and found that for every 1-point increase in a Patient Health Questionnaire 9 (PHQ-9) score (a measure of depression severity); patients experienced an additional mean productivity loss of 1.65%. Even minor levels of depression symptoms were associated with decreases in work function. The U.S. Preventive Services Task Force (USPSTF) recommends screening for depression among adolescents 12-18 years and the general adult population, including pregnant and postpartum women.