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									         Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                Use Case Development and Functional Requirements for Interoperability
                         Transition of Care and Plan of Care for LTPAC Use Case




     Longitudinal Coordination
         of Care Initiative
      Elements in Transition of Care and Plan of Care
              for LTPAC Baseline Use Case

                                          4/2/20124/2/2012


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    8/1/2011                                                                                      1
         Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                Use Case Development and Functional Requirements for Interoperability
                         Transition of Care and Plan of Care for LTPAC Use Case
1                                            Version Control

       Date   Version         Owner                Source               Description of Changes
    3/26/2012 v.01       UCR Support Team    ToC Use Case V1.1    Add LCC ToC and PoC information
                                             and with LTPAC ToC   and scenarios for first draft of
                                             and PoC updates      document.
    4/18/2012 v.02     UCR Support Team      Workgroup Scoping    Revised to reflect the consensus
              Sections                       Discussions          scope and related language
              1–5                                                 throughout established on 4/12 at
              Only                                                the LCC Face to Face Meeting
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    8/1/2011                                                                                          2
              Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                     Use Case Development and Functional Requirements for Interoperability
                              Transition of Care and Plan of Care for LTPAC Use Case
1    Table of Contents
2    List of Figures .............................................................................................................................................. 34
3    List of Tables ................................................................................................................................................. 4
4    1.0 Preface and Introduction ...................................................................................................................... 56
5    2.0 Overview and Scope.............................................................................................................................. 56
6       2.1 In Scope ............................................................................................................................................... 7
7       2.2 Out of Scope........................................................................................................................................ 7
8       2.3 Background ......................................................................................................................................... 7
9       2.4 Policy Issues ...................................................................................................................................... 98
10      2.5 Regulatory Issues ............................................................................................................................ 108
11      2.6 Communities of Interest ............................................................................................................... 1310
12   3.0 Challenge Statement ......................................................................................................................... 1511
13   4.0 Value Statement ............................................................................................................................... 1612
14   5.0 Use Case Assumptions ...................................................................................................................... 1812
15   APPENDICES .......................................................................................................................................... 1954
16      Appendix A: Related Use Cases........................................................................................................... 1954
17      Appendix B: Previous Work Efforts Related to Clinical Information Exchange ................................. 1954
18      Appendix C: Privacy and Security Assumptions .................................................................................. 2155
19      Appendix D: Glossary .......................................................................................................................... 2156
20      Appendix E. References ...................................................................................................................... 2358
21


22   List of Figures
23   Figure 1: Use Case Diagram ....................................................................... Error! Bookmark not defined.15
24   Figure 2: Context Diagram ......................................................................... Error! Bookmark not defined.16
25   Figure 3: Activity Diagram of Scenario 1 User Story 1 ............................... Error! Bookmark not defined.23
26   Figure 4: Activity Diagram of Scenario 1 User Story 2 ............................... Error! Bookmark not defined.24
27   Figure 5: Sequence Diagram of Scenario 1 User Story 1............................ Error! Bookmark not defined.26
28   Figure 6: Sequence Diagram of Scenario 1 User Story 1............................ Error! Bookmark not defined.27
29   Figure 7: Activity Diagram of Scenario 2 User Story 1 ............................... Error! Bookmark not defined.32
30   Figure 8: Activity Diagram for Scenario 2 User Story 2 .............................. Error! Bookmark not defined.33
31   Figure 9: Sequence Diagram for Scenario 2 User Story 1 .......................... Error! Bookmark not defined.35
32   Figure 10: Sequence Diagram of Scenario 2 User Story 2.......................... Error! Bookmark not defined.36




     8/1/2011                                                                                                                                                        3
             Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                    Use Case Development and Functional Requirements for Interoperability
                             Transition of Care and Plan of Care for LTPAC Use Case
1    List of Tables
2    Table 1: Communities of Interest ........................................................................................................... 1511
3    Table 2: Actors and Roles of Use Case ....................................................... Error! Bookmark not defined.14
4    Table 3: Actors and Roles for Scenario 1 User Story 1 ............................... Error! Bookmark not defined.17
5    Table 4: Actors and Roles for Scenario 1 User Story 2............................... Error! Bookmark not defined.19
6    Table 5: Base Flow of Scenario 1 User Story 1 ........................................... Error! Bookmark not defined.22
7    Table 6: Base flow of Scenario 1 User Story 2 ........................................... Error! Bookmark not defined.22
8    Table 7: Information Exchange Requirements of Scenario 1 .................... Error! Bookmark not defined.25
9    Table 8: System Requirements of Scenario 1 ............................................ Error! Bookmark not defined.25
10   Table 9: Actors and Roles of Scenario 2 User Story 1 ................................ Error! Bookmark not defined.28
11   Table 10: Actors and Roles of Scenario 2 User Story 2 .............................. Error! Bookmark not defined.29
12   Table 11: Base Flow of Scenario 2 User Story 1 ......................................... Error! Bookmark not defined.30
13   Table 12: Base Flow of Scenario 2 User Story 2 ......................................... Error! Bookmark not defined.31
14   Table 13: Informational Exchange Requirements of Scenario 2 User Story 1 .............. Error! Bookmark not
15   defined.34
16   Table 14: System Requirements of Scenario 2 .......................................... Error! Bookmark not defined.34
17   Table 15: Dataset for Discharge Instructions ............................................. Error! Bookmark not defined.40
18   Table 16: Dataset for Discharge Summary................................................. Error! Bookmark not defined.44
19   Table 17: Dataset for Clinical Summary ..................................................... Error! Bookmark not defined.49
20   Table 18: Dataset for Clinical Summary for Specialist Notes ..................... Error! Bookmark not defined.54


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     8/1/2011                                                                                                                                       4
             Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                    Use Case Development and Functional Requirements for Interoperability
                             Transition of Care and Plan of Care for LTPAC Use Case
1    1.0 Preface and Introduction
2    To fully realize the benefits of health IT, the Office of the National Coordinator for Health Information
3    Technology (ONC), as part of the Standards and Interoperability (S&I) Framework is developing Use
4    Cases that define the interoperability requirements for high priority health care data exchange;
5    maximize efficiency, encourage rapid learning, and protect patients’ privacy in an interoperable
6    environment. These Use Cases address the requirements of a broad range of Communities of Interests
7    including; patients, their significant others and family members, providers, vendors, standards
8    organizations, public health organizations, and Federal agencies.

9    These Use Cases describe:

10           The operational context for the data exchange
11           The stakeholders with an interest in the Use Case
12           The information flows that must be supported by the data exchange
13           The types of data required in the data exchange

14   The Use Case is the foundation for identifying and specifying the standards required to support the data
15   exchange and developing reference implementations and tools to ensure consistent and reliable
16   adoption of the data exchange standards.


17   2.0 Overview and Scope
18   This Use Case, Longitudinal Coordination of Care, defines a baseline for electronic communication and
19   data elements necessary for clinical information exchange to support longitudinal coordination of care
20   (LCC), transitions of care (ToC) and instances of shared care (SC) between providers in Acute Care sites
21   and Long Term and Post Acute Care (LTPAC) sites; and to inform patients and keep them involved in the
22   management of their care.

23   The LCC Baseline Use Case extends the ToC Use Case into the complex requirements for information
24   exchange between Acute Care Hospitals (ACH) and LTPAC sites, among LTPAC sites and between LTPAC
25   sites and patients. In addition, ToC/ PoC Phase 2 extends beyond additional Transitions of Care                 Comment [kc1]: Do we want to use Phase
26   requirements to an initial set of Plan of Care requirements based on the CMS 485 Homecare Plan of               language or stay consistent in referring to this as the
                                                                                                                     “Baseline”
27   Care (formerly known as the CMS 485).

28   With this in mind, the Use Case is comprised of 3 Scenarios:

29       1. Scenario 1: Provider to Provider data exchanges for Transitions of Care that support the
30          following interactions:
31               a. Acute Care Hospital to LTPAC site (Discharge);
32               b. LTPAC Site to Emergency Department (Consultation Request);
33               c. Emergency Department to LTPAC Site (Consultation Summary).
34       2. Scenario 2: Provider to Provider data exchanges for the Home Health AgencyHomecare Plan of
35          Care (PoC) including the following user stories:
36               a. Initial & Recertification PoC: Home Health Agency (HHA) to Physician, Physician to HHA;
37               b. Interim Changes to PoC: HHA to Physician, Physician to HHA.
38       3. Scenario 3: Provider to Patient data exchanges that provide a copy of the provider to provider
39          data to the patient/ delegate including both Transitions of Care and Plan of Care data
40          exchanges.


     8/1/2011                                                                                                    5
             Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                     Use Case Development and Functional Requirements for Interoperability
                               Transition of Care and Plan of Care for LTPAC Use Case
 1   Scenario 1 – Provider to Provider Transitions of Care Baseline Transactions focus on the exchange of
 2   patient information between multi-disciplinary teams of providers across acute and post acute care sites
 3   to support care coordination, management, and service delivery by ensuring that needed clinical
 4   information is received (when authorized) by the multiple providers involved in a patient’s care and
 5   supports successful transitions in care from one care environment to another. These transactions are         Comment [M2]: What is “successful”? Should
 6   meant to provide a generic LTPAC data set, which will be based on the requirements defined for Home          we use Terry’s and Larry’s words (safe and ______)?

 7   Health Agencies (HHAs) or Skilled Nursing Facilities (SNFs)Nursing Homes (NHs) depending on the user
 8   story. The LCC WG has determined that using HHAs and SNFs NHs as the initial sites to inform the
 9   generic LTPAC transition will provide a high degree of overlap and utility with other LTPAC sites, e.g.
10   Inpatient Rehabilitation Facilities (IRFs). This Use Case includes referrals for the purpose of
11   consultations, however, transitions within the same care setting are not included in the scope of this
12   Initiative. Because of CMS mandates for standardized assessment tools for HHAs and SNFNursing
13   Homes, the OASIS C and MDS 3.0 respectively, most LTPAC sites already collect and transmit
14   electronically some clinical information. Re-using the data elements captured in these reporting
15   instruments to improve transitions and longitudinal coordination of care is an important strategy and
16   requires standardization of data elements and interoperability across all sites of care.

17   Scenario 2 – Home Health AgencyHomecare Plan of Care: These transactions focus on the sharing of
18   electronic clinical information between HHAs and the physician signing orders for the patient. This
19   represents a frequent data interchange between HHA and Physician, including the signing and
20   authorization of the plan, in a circumstance where the patient remains static in the home environment.
21   The CMS OASIS C reporting instrument will be evaluated to determine which elements can be leveraged
22   to generate the HHA Homecare PoC.

23   Note: It is important to distinguish the HHA Homecare PoC from the Plan of Care section in the current
24   C-CDA. While the C-CDA plan of care section may be utilized for some of the LCC PoC data elements, the
25   LCC PoC is more broadly conceived and will likely utilize many sections of the C-CDA as appropriate.
26   Please see section 2.3.2 of this Use Case for a detailed background on the HHA Homecare PoC that is
27   based on the now retired CMS 485 Form.

28   Scenario 3 - Acute and LTPAC Provider to Patient: These transactions focus on the sharing of electronic
29   clinical information from Acute Care Hospitals and LTPAC providers to their patients, including the data
30   interchange required to support the needs of a patient during transitions of care, and/or to keep the
31   patient/consumer/ delegate (e.g., family member) informed of the patient’s status. In this scenario, the
32   patient has the ability to access and incorporate their available clinical information into their PHR. The
33   emphasis in Scenario 3 is on patients transferred to or from LTPAC sites of care as well as the
34   HHAHomecare Plan of Care that is utilized to manage a patient’s care while receiving HHA services.

35   For all three scenarios, it is important to have common HIE transport standards for the secure and
36   interoperable exchange of electronic health information needed to support shared care, care planning,
37   and transitions in care. Furthermore, the data elements themselves must be defined, collected and
38   interpreted similarly across all care sites.

39   Successful outcomes and metrics of this Use Case include: [This needs to be updated, once the Success
40   Metrics Committee has completed their work – HM]                                                             Comment [M3]: Does this currently reflect the
                                                                                                                  final success metrics identified by the ToC?
41       1. The number of providers (by provider type) electronically sending: (a) Transitions of Care            Comment [M4]: Will “transitions of care
42          summaries based on LTPAC specifications and (b) HHA Homecare PoC.                                     summaries” be defined broadly enough to also
                                                                                                                  include Patient Assessment Summaries? (Note: this
                                                                                                                  comment applies to items 1-6)

     8/1/2011                                                                                                 6
           Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                   Use Case Development and Functional Requirements for Interoperability
                            Transition of Care and Plan of Care for LTPAC Use Case
 1       2. The number of providers (by provider type) electronically receiving: (a) Transitions of Care
 2          summaries based on LTPAC specifications and (b) HHA Homecare PoC.
 3       3. The number of patients/consumers electronically receiving: (a) Transitions of Care summaries
 4          based on LTPAC specifications and (b) HHA Homecare PoC.
 5       4. The number of vendor products that have been certified to produce valid specifications              Comment [M5]: Shouldn’t this read “comply
 6          (Software development/Tools organizations)                                                          with applicable LTPAC specifications”

 7       5. The time reduction for creation of new minimal unstructured ToC summaries and structured
 8          ToC summaries
 9       6. The percentage, per sender, of interoperable exchange of: (a) Transitions of Care summaries
10          based on LTPAC specifications and (b) HHA Homecare PoC.
11       7. Improvement in ability to achieve all currently defined MU criteria.

12   2.1 In Scope
13          Clinical Summary information and its basic dataset(s) for the Transition of Care to include the
14           transfer of care and the exchange of clinical information between providers and between
15           providers and patients.
16          The Home Health AgencyHomecare Plan of Care information and its basic data sets necessary to
17           perform the initial, interim and recertification functions in the HHA setting and to inform
18           patients and care givers of patient status and medical course updates.
19          For the purposes of this Use Case, LTPAC transactions will be based on the data requirements
20           defined by the HHA or SNF Nursing Home trading partners depending on the specific user story.

21   2.2 Out of Scope
22          The comprehensive EHR
23          Financial Information, except for basic insurance information, will not be sent
24          While Query Transactions are out of scope, consideration of metadata necessary to tag clinical
25           summaries to support queries is within scope.
26          Sharing of clinical summaries for other purposes; e.g., claims submission
27          Transmission protocols are out of scope since the providers would not need to address the
28           transport, though the system itself (outside the scope of a use case) would have to address the
29           most efficient means of transport from sender to receiver.
30          Transitions within the same care setting (i.e. within the same legal organization)
31          Defining or modifying existing clinical medicine practices
32          Definition of requirements and data sets for Patient Assessment Summary Documents (PASDs) is
33           out of scope. The Keystone Beacon project can be referenced for the detailed requirements for      Comment [M6]: This conflicts with the sentence
34           PASDs and the S&I Harmonization team is conducting an analysis of how this instrument              highlighted at line 13 on page 8.

35           compares to the current standards.

36   2.3.1 General Background
37   Information exchange to support the a broad array of Health Transitions of Care is essential to
38   healthcare reform because its implementation will contribute to the overall cost savings within the US
39   health system through enhanced care coordination, improved clinical outcomes and care efficiency, and
40   decreased adverse events. This Use Case is expected to support the development of key elements of
41   the Nationwide Health IT Infrastructure as required in HITECH by enabling the electronic exchange and
42   use of health information needed to support quality and coordination of, and efficiencies in care as
43   individuals transition across health care settings and experience care that is shared across multiple
44   health care providers. This Use Case is aligned closely with the goals of Meaningful Use Stage 1 and the


     8/1/2011                                                                                               7
             Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                      Use Case Development and Functional Requirements for Interoperability
                                Transition of Care and Plan of Care for LTPAC Use Case
1    Meaningful Use Stage 2 NPRM which has begun to recognize the need to include LTPAC settings
2    particularly in the context of the Care Coordination objective. The data elements defined as part of this
3    Use Case anticipate Meaningful Use Stage 3 by enabling the re-use of clinically essential information for
4    the purposes of quality measurement and standardization of assessments across sites of care.
5    Furthermore, the data exchange capabilities defined in this Use Case support evidenced based medicine                 Comment [kc7]: Possible replacement: “The
6    and research initiatives including Comparative Effectiveness Research and other high priority research                requirements defined in this Use Case will inform
                                                                                                                           the deliberations relative to Meaningful Use Stage 3
7    initiatives that align with the Nation’s agenda to improve the quality and coordination of care while                 recommendations in both the Health Information
8    reducing its costs.1                                                                                                  Technology Policy Committee and Health
                                                                                                                           Information Technology Standards Committee.”
 9   This Use Case extends the ToC V1.1 improvements in care coordination and patient engagement in their
10   own healthcare, in order that the strong foundation of Meaningful Use Stages 1 and 2 can be further
11   strengthened with the requirements developed for Meaningful Use Stage 3. Advancing the exchange of
12   transfer of care documents, and care plans that evolve as a result of exchanges between
13   organizationally unaffiliated providers (physicians and HHAs) will lay a strong foundation for supporting
14   the specification of vocabulary and document exchange standards that will be needed for longitudinal
15   care plan which will cross multiple sites of care, involve multiple disciplines and require iterative
16   exchanges among participants including the patient.

17   The technical feasibility of this Initiative requires and supports information exchange. The LCC Use Case
18   specifically leverages existing interoperability standards; thus, many of the Healthcare Information
19   Technology Standards Panel (HITSP) specifications (Appendix B) apply, as well as using standards such
20   as Health Level Seven (HL7) Continuity of Care Document (CCD) (which was produced as the result of an
21   MOU between two Standards Development Organizations and leveraged standards advanced by these
22   organizations, - the HL7 CDA and ASTM Continuity of Care Record (CCR)) and the HL7 CDA
23   Implementation Guide for Patient Assessment Questionnaires. These foundational documents have all
24   been considered in the development of the Consolidated CDA (C-CDA) templates that provide
25   implementation guidance for the CCD and Discharge Summary among other documents. The LCC Use
26   Case intends to align with the C-CDA, in particular, because the Meaningful Use (MU) Stage 2 Notice of
27   Proposed Rule-making (NPRM) [reference to NRPM online] identifies C-CDA as the applicable standard
28   for summary and discharge documents.

29   In summary, the LCC Use Case draws heavily from the ToC V1.1 Use Case, intends to align with known
30   standards and identifies the data elements necessary for effective transitioning and planning in the
31   LTPAC environment.

32   2.3.2 Background Specific to the Home Health AgencyHomecare Plan of Care
33   The homecare provider provides services to the patient as ordered by the physician. Throughout the
34   episode of homecare, the homecare provider and the physician exchange information about the
35   patient’s evolving condition and needs, and the services that the homecare provider will perform. For
36   Certified Home Health Agencies (CHHA), the Centers for Medicare and Medicaid Services (CMS) has
37   specified the content of this exchange in the 485 form (see example in Appendix F).                                   Comment [M8]: Doesn’t this need to be revised
                                                                                                                           to reflect “former 485 form”?




     1
       Comparative Effectiveness Research (CER) evaluates existing health care interventions to determine which work
     best for a particular patient as well as which treatments might have a deleterious effect and under what
     circumstances they are most likely to cause the greatest harm. According to the Institute of Medicine: “CER assists
     consumers, clinicians, purchasers, and policy makers in making informed decisions that will improve health care at
     both the individual and population levels."

     8/1/2011                                                                                                          8
            Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                      Use Case Development and Functional Requirements for Interoperability
                                Transition of Care and Plan of Care for LTPAC Use Case
 1   When the physician refers the patient for homecare, he/she provides current medical information and
 2   general orders for homecare. The CHHA homecare provider, by regulation, is required to perform a
 3   comprehensive assessment, completing the OASIS as established by CMS and additional items to create
 4   a comprehensive assessment. The assessment addresses the patient’s medical condition, functional
 5   limitations in Activities of Daily Living (ADL), physical home environment, availability of in-home support
 6   from family members or other caregivers, and other factors. The assessment also includes a complete
 7   inventory of all of the prescribed, over-the-counter, and herbal and biological medications the patient is
 8   taking in the home, which the nurse reviews and reconciles with the physician; a reconciliation of the
 9   patient’s allergies to medications, foods, and the environment; and an evaluation of the patient’s
10   mental status, including screening for depression. Based on this comprehensive assessment, the nurse
11   proposes a regimen of services to the patient, and goals for treatment. The service regimen specifies
12   the frequency of visits by each homecare discipline (nursing, rehab therapy, social work, etc.) and the
13   duration (in weeks) of such services; the Durable Medical Equipment (DME) that the homecare provider
14   should furnish to the patient; and any specialized types of treatment, such as specific wound care.

15   The homecare provider sends this assessment and treatment plan to the physician as the homecare Plan
16   of Care (the 485 form). The physician reviews this against the information in the patient’s chart,
17   updates his/her records, makes any changes to the Plan of Care, signs his/her approval, and sends it
18   back to the homecare provider.

19   Throughout the homecare episode, which may range from several days to many months, the homecare
20   provider makes changes in the Plan of Care as the patient’s condition and needs change, sending each
21   change to the physician for review and approval. The physician can also initiate changes to the Plan of
22   Care as his/her assessment of the patient’s conditions and needs develop over time.

23   Homecare providers cannot bill Medicare or Medicaid for services until the physician has approved
24   them in the Plan of Care. Homecare providers therefore spend a good deal of effort following up with
25   physicians to have them sign the initial Plan of Care and subsequent changes.

26   In almost all cases today, the 485 travels between the homecare provider and the physician as a paper
27   or faxed form. This is true even though the homecare provider may generate the Plan of Care from data
28   it holds in electronic form in its EMR, and even though the physician may use an EMR for all of his/her
29   patient records. [reference to Homecare PoC Use Case on wiki]

30   Please see the Homecare Plan of Care “Developing Interoperability Standards for Homecare Plan of
31   Care: Use Case” document developed by the Visiting Nursing Services of New York (VNSNY) in
32   collaboration with relevant stakeholders for a detailed view of the operational aspects of exchanging the
33   HPoC. The Baseline Use Case will focus only on the requirements needed for the HPoC transactions.
34   more detail on the                                                                                            Comment [M9]: Sentence was not completed.


35

36   2.4 Policy Issues
37   While the LCC Use Case is informed by the current policy environment, it is NOT the intention of this
38   document to set forth a detailed policy position. The LCC WG will produce a separate white paper that
39   will provide a data interoperability-focused supplement to the existing policy work produce by AHIMA/
40   ASPE [need footnote].



     8/1/2011                                                                                                  9
             Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                      Use Case Development and Functional Requirements for Interoperability
                               Transition of Care and Plan of Care for LTPAC Use Case
1    It is important, however, to briefly identify the relevant policy drivers. To that end, the Affordable Care
2    Act (ACA) mandates multiple pilots involving coordination of care, particularly at transitions in care and
3    for instances of shared care. The LCC WG seeks to inform the discussions of both the Health
4    Information Technology Policy Committee (HITPC) and the Health Information Technology Standards
5    Committee (HITSC) by defining interoperability standards applicable to LTPAC providers as well as laying
6    out a long-term roadmap for a longitudinal care record that includes a longitudinal care plan.

 7   A policy driver for the HIT Policy Committee is to recognize the need to support and advance
 8   interoperable electronic exchange and use of health information on behalf of persons who receive
 9   LTPAC services. While LTPAC providers are not included in the Medicare and Medicaid Meaningful Use
10   Programs, as described in this use case, patients served by LTPAC are concurrently served by and
11   transition across health care settings by those Eligible Professionals and Eligible Hospitals that do qualify
12   for incentives under the Meaningful Use program. The Meaningful Use Stage 2 NPRM improves the
13   standing of LTPAC with several references to LTPAC settings as well as longitudinal care planning, but
14   there must be additional specificity in both the MU 2 NPRM and in the EHR Certification Criteria to
15   specifically identify the role and inclusion of LTPAC sites in the fulfillment of MU requirements.

16   The LCC WG is also positioned to inform the work of the HITSC by developing detailed interoperability
17   specifications that are appropriate for LTPAC settings. This will be accomplished in the first by extending
18   the Transitions of Care work accomplished to date. Second, the LCC WG and this Use Case will define
19   some foundational Plan of Care transactions to set a practical starting place for the broader Longitudinal
20   Coordination of Care work to further define interoperability for shared care to follow.

21   The User Story and Activity Diagrams represent a generalized flow of information exchange, but do not
22   represent infrastructure, architecture, or workflow requirements. They show what information needs to
23   go from place A to place B to achieve a clinically sound transfer of care and enable shared care for the
24   patient; however, they do not dictate the content or format of this information nor the specific
25   transactions for the transfer of this information. It is left to policy makers to determine what
26   requirements are applied to providers.

27   2.5 Regulatory Issues
28   Implementation of the LCC Use Case supports the following regulatory requirements from Meaningful
29   Use Stage 1 as well as the requirements proposed in Meaningful Use Stage 2:
30
31   The Final Rule for Health Information Technology: Initial Set of Standards, Implementation
32   Specifications, and Certification Criteria for Electronic Health Record Technology for Meaningful Use
33   Stage 1 state the following:

34       A. Initial Set of Standards, Implementation Specifications, and Certification for Electronic Health
35       Record Technology (July 2010) identified the following standard for Engagement of Patients and
36       Families in their Healthcare:
37
38       (1) Electronic Copy of Health Information: Electronic copy of health information. Enable a user to
39       create an electronic copy of a patient’s clinical information, including, at a minimum: diagnostic test
40       results, problem list, medication list, and medication allergy list in: (1) Human readable format; and
41       (2) On electronic media or through some other electronic means in accordance with: (i) The standard
42       (and applicable implementation specifications) specified in §170.205(a)(1) or §170.205(a)(2); and (ii)
43       For the following data elements the applicable standard must be used:


     8/1/2011                                                                                                  10
           Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                     Use Case Development and Functional Requirements for Interoperability
                               Transition of Care and Plan of Care for LTPAC Use Case
 1       (A) Problems. The standard specified in §170.207(a)(1) or, at a minimum, the version of the standard
 2       specified in §170.207(a)(2);
 3       (B) Laboratory test results. At a minimum, the version of the standard specified in §170.207(c); and
 4       (C) Medications. The standard specified in §170.207(d) Electronic Copy of *Discharge Instructions:
 5       Electronic copy of discharge instructions enable a user to create an electronic copy of the discharge
 6       instructions for a patient, in human readable format, at the time of discharge on electronic media or
 7       through some other electronic means.
 8
 9       (2) *Electronic Copy of Discharge Instructions: Electronic copy of discharge instructions. Enable a
10       user to create an electronic copy of the discharge instructions for a patient, in human readable
11       format, at the time of discharge on electronic media or through some other electronic means.
12
13       (3) Clinical Summaries for each Office Visit: Clinical summaries enable a user to provide clinical
14       summaries to patients for each office visit that include, at a minimum: diagnostic test results,
15       problem list, medication list, and medication allergy list. If the clinical summary is provided
16       electronically it must be: (1) Provided in human readable format; and (2) Provided on electronic
17       media or through some other electronic means in accordance with: (i) The standard (and applicable
18       implementation specifications) specified in §170.205(a)(1) or §170.205(a)(2); and (ii) For the
19       following data elements the applicable standard must be used:
20       (1) Problems. The standard specified in §170.207(a) (1) or, at a minimum, the version of the
21       standard specified in §170.207(a) (2);
22       (2) Laboratory test results. At a minimum, the version of the standard specified in §170.207(c); and
23       (3) Medications. The standard specified in §170.207(d).
24
25       B. Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic
26       Health Record Technology (July, 2010) identified the following standard for Improvement in Care
27       Coordination:
28
29       (1) Enable a user to create an electronic copy of a patient’s clinical information, including, at a
30       minimum, diagnostic test results, problem list, medication list, medication allergy list, and
31       procedures: (I) In human readable format, and (ii) on electronic media or through some other
32       electronic means in accordance with: (A) The standard (and applicable implementation
33       specifications) specified in §170.205(a)(1) or §170.205(a)(2); and (B) For the following data elements
34       the applicable standard must be used:
35
36       (1) Problems. The standard specified in §170.207(a) (1) or, at a minimum, the version of the
37       standard specified in §170.207(a) (2);
38       (2) Procedures. The standard specified in §170.207(b) (1) or §170.207(b) (2);
39       (3) Laboratory test results. At a minimum, the version of the standard specified in §170.207(c); and
40       (4) Medications. The standard specified in §170.207(d).
41
42   (2) Enable a user to create an electronic copy of a patient’s discharge summary in human readable
43   format and on electronic media or through some other electronic means

44   The Meaningful Use Stage 2 Proposed Rule, sets out the likely elements of the final rule and asks for
45   specific public comment. Note the following sections from the Health Information Technology:
46   Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record


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          Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                   Use Case Development and Functional Requirements for Interoperability
                             Transition of Care and Plan of Care for LTPAC Use Case
1    Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information
2    Technology:

3    [Provide Section information for all MU2 PR references below]

 4         Consistent with our discussion in the preamble section titled “Explanation and Revision of Terms
 5         Used in Certification Criteria,” we have replaced the terms “modify” and “retrieve” in the
 6         recommended criterion with “change” and “access,” respectively. Further, consistent with the
 7         interpretation we provided in the S&CC July 2010 final rule, we are reiterating and clarifying that
 8         “longitudinal care” is used to mean over an extended period of time. For the ambulatory setting,
 9         this would be over multiple office visits. For the inpatient setting, this would be for the duration
10         of an entire hospitalization, which would include the patient moving to different wards or units
11         (e.g., emergency department, intensive care, and cardiology) within the hospital during the
12         hospitalization. The HITSC suggested that we consider longitudinal care to cover multiple
13         hospitalizations, but we believe this could be difficult to achieve and may not offer added value
14         based on the duration of time between a patient’s hospitalizations and the reason for the
15         hospitalizations. To note, our clarification of the meaning of longitudinal care applies equally to
16         its use in other certification criteria, such as “medication list” and “medication allergy list.” If we
17         were to change our interpretation of longitudinal care as suggested by the HITSC, it would apply
18         to these certification criteria as well and could constitute a change in the capabilities included in
19         the criteria, which in turn would cause them to become revised certification criteria. We
20         welcome comments on our interpretation of longitudinal care. We also welcome comments on
21         whether a term other than “longitudinal care” could and should be used to express the capability
22         required by this certification criterion and the other referenced certification criteria (“medication
23         list” and “medication allergy list”). We understand that the longitudinal care description we use
24         for the purposes of EHR technology certification may differ from the meaning that providers
25         attribute to it, including the meaning given to it by the Longitudinal Coordination of Care
26         Workgroup within the Standards and Interoperability Framework30. [Clean up references – P.53].
27
28         As we continue to adopt new and revised certification criteria to support MU, we believe that it is
29         prudent to seek public comment on whether we should focus our efforts on the certification of
30         the HIT used by health care providers that are ineligible to receive incentives under the EHR
31         Incentive Programs. In particular, we are interested in commenters’ thoughts on whether we
32         should consider adopting certification criteria for other health care settings, such as the long-
33         term care, post-acute care, and mental and behavioral health settings. For those commenters
34         that believe we should consider certification criteria for other health care settings, we
35         respectfully request that their comments specify the certification criteria that would be
36         appropriate as well as the benefits they believe a regulatory approach would provide. Last, we
37         ask that the public consider whether the private sector could alternatively address any perceived
38         need or demand for such certification. For example, we are aware that the Certification
39         Commission for Health Information Technology (CCHIT) has certification programs for long-term
40         and post-acute care as well as behavioral health EHR technology.44. [Clean up references –
41         P.133].
42
43         We are interested in whether commenters believe that EHR technology certified to the 2014
44         Edition EHR certification criteria should be capable of recording the functional, behavioral,
45         cognitive, and/or disability status of patients (collectively referred to as “disability status”). The
46         recording of disability status could have many benefits. It could facilitate provider identification

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           Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                     Use Case Development and Functional Requirements for Interoperability
                               Transition of Care and Plan of Care for LTPAC Use Case
 1          of patients with disabilities and the subsequent provision of appropriate auxiliary aids and
 2          services for those patients by providers. It could also promote and facilitate the exchange of this
 3          type of patient information between providers of care, which could lead to better quality of care
 4          for those with disabilities. Further, the recording of disability status could help monitor
 5          disparities between the “disabled” and “nondisabled” population.
 6
 7          We are specifically requesting comment on whether there exists a standard(s) that would be
 8          appropriate for recording disability status in EHR technology. We are aware of a standard for
 9          disability status approved by the Secretary for use in population health surveys sponsored by
10          HHS46 and standards under development as part of the Standards and Interoperability
11          Framework and the Continuity Assessment Record and Evaluation (CARE) assessment tool47. We
12          welcome comments on whether these standards or any other standards would be appropriate
13          for recording disability status in EHR technology.
14
15          We ask that commenters consider whether the recording of disability status should be a required
16          or optional capability that EHR technology would include for certification to the 2014 Edition EHR
17          certification criteria. We also ask commenters to consider whether the recording of disability
18          status should be part of a Base EHR and included in a separate certification criterion or possibly
19          the “demographics” certification criterion (§ 170.314(a)(3)). Last, we ask commenters to consider
20          whether disability status recorded according to the standard should also be included in other
21          certification criteria such as “transitions of care – incorporate summary care record”
22          (§170.314(b)(1)), “transitions of care – create and transmit summary care record”
23          (§170.314(b)(2)), “view, download and transmit to 3rd party” (§ 170.314(e)(1)), and “clinical
24          summaries” (§ 170.314(e)(2)). [Clean up references – P.135-6].
25
26          (5) Problem list. Enable a user to electronically record, change, and access a patient’s problem list
27          for longitudinal care in accordance with, at a minimum, the version of the standard specified in §
28          170.207(a)(3).
29
30          (6) Medication list. Enable a user to electronically record, change, and access a patient’s active
31          medication list as well as medication history for longitudinal care.
32
33          (7) Medication allergy list. Enable a user to electronically record, change, and access a patient’s
34          active medication allergy list as well as medication allergy history for longitudinal care. [Clean up
35          references – P.164-165].
36

37   2.6 Communities of Interest
38   Communities of Interest are public and private stakeholders that are directly involved in the business
39   process or are involved in the development and use of interoperable implementation guides and in their
40   actual implementation. Communities of Interest may directly participate in the exchange; that is, they
41   are business actors; or indirectly through the results of the improved business process.

42   The following list of Communities of Interest and their definitions are for discussion purposes for Clinical
43   Information Exchange.

       Member of Communities of Interest               Working Definition
       Patient                                         Members of the public who require healthcare services

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      Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
             Use Case Development and Functional Requirements for Interoperability
                      Transition of Care and Plan of Care for LTPAC Use Case
 Member of Communities of Interest           Working Definition
                                             from ambulatory, emergency department, physician’s
                                             office, and/or the public health agency/department and
                                             LTPAC sites of care.
 Consumers                                   Members of the public that include patients as well as
                                             caregivers, patient advocates, surrogates, family
                                             members, and other parties who may be acting for, or
                                             in support of, a patient receiving or potentially
                                             receiving healthcare services.
 Care Coordinators                           Individuals who support clinicians, patients, and/or
                                             other consumers in the management of health and
                                             disease conditions, physical and cognitive functioning,
                                             and issues related to health and human services .
                                             These can include case managers and others.
 Clinicians                                  Healthcare providers with patient care responsibilities,
                                             including physicians, advanced practice nurses,
                                             physician assistants, nurses, psychologists, pharmacists,
                                             social workers, therapists, and other licensed and
                                             credentialed personnel involved in treating patients.

                                              Includes an individual clinician in a care delivery setting
                                              who requests, submits or accepts the transfer of the
                                              clinical summary for the purposes of delivering care.
 Laboratories                                 A laboratory (often abbreviated lab) is a setting where
                                              specimens are sent for testing and analysis are
                                              resulted, and then results are communicated back to
                                              the requestor. The types of laboratories may include
                                              clinical/medical, and environmental, and may be both
                                              private and/or public.
 Pharmacies                                   Entities that exist that are experts on drug therapy and
                                              are the primary health professionals who optimize
                                              medication use to provide patients with positive health
                                              outcomes
  Provider                                    Includes a wide array of individual providers and
                                              provider organizations that are engaged in or support         Comment [M10]: The examples of “provider
                                              the delivery of health and human services. Includes           organizations” provided here do not match the
                                                                                                            highlighted description of “provider organizations”
                                              Hospitals (including short-term acute care hospitals and      immediately below.
                                              specialty hospitals (e.g., long-term care hospitals,          Comment [kc11]: Provider organization is
                                              rehabilitation facilities, and psychiatric hospitals)),       included as part of the global provider definition.
                                              Ambulatory Centers, Provider Practices, Nursing
                                              Homes, Home and Community-Based Service Providers
                                              (e.g., Home Health Agencies, Hospice, Adult Day Care
                                              Centers, etc. ), and human and social service providers
                                              (e.g., transportation).
 Provider Organizations                       Organizations that: are either vertically and/or
                                              horizontally integrated configurations of providers,
                                              typically sharing a common governance body, and are

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           Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                   Use Case Development and Functional Requirements for Interoperability
                            Transition of Care and Plan of Care for LTPAC Use Case
       Member of Communities of Interest           Working Definition
                                                   engaged in or support the payment, delivery, and/or
                                                   management of healthcare and/or long-term care
                                                   services. Examples of such organizations include: IDNs,
                                                   ACOs
       Standards Organizations                     Organizations whose purpose is to define, harmonize
                                                   and integrate standards that will meet clinical, and
                                                   business needs for sharing information among
                                                   organizations and systems
       Federal Agencies                            Organizations within the federal government that
                                                   deliver, regulate or provide funding for health care,
                                                   long-term care, and/or human services.

       Electronic Health Record/Personal Health         Vendors which provide clinicians and consumers
       Record and HISP (Health Information              specific EHR/PHR solutions such as software
       Service Provider) Vendors                        applications and software services.
                                                        HISP organizations provide the technical capability to
                                                        transmit the ToC messages across diverse EHR/PHR
                                                        systems. These suppliers may include developers,
                                                        providers, resellers, operators, and others who may
                                                        provide these or similar capabilities.
       Health Information Exchanges (HIEs)              Need definition of HIEs                                       Comment [kc12]: Consider HISP definition
                                                                                                                      above and whether we need to specifically call out
                                                                                                                      HIE of the implication is that HISP encompasses HIEs
                                                                                                                      as well as others like RHIOs, etc…

1                                            Table 1: Communities of Interest



 2   3.0 Challenge Statement
 3   Meaningful Use Stage 1 and proposed Stage 2 criteria require information to be exchanged in transitions
 4   of care. Additionally, this Use Case recognizes that a significant number of shared care interactions
 5   occur, in the form of the plan of care, between disparate providers when a patient remains in the same
 6   care setting. Implementers are often confused about how to adopt the specifications for exchange of
 7   the required data for both transition and non-transition shared care. The content of any exchange is
 8   only as good as its fidelity to source, assured identity, provenance, completeness, audit/traceability, full
 9   context, along with permissions and qualifications. Without ensuring these characteristics across
10   information exchanges such that all are fully evident to the receiver (and ultimate user), no exchange is
11   valid. Furthermore, this exchange is dependent on a secure, interoperable environment.

12   Different transition and non-transition scenarios may require different types of artifacts (e.g. a transition
13   from inpatient to ambulatory may require a discharge summary; a transition from primary care provider
14   to specialist may require a referral summary, a stationary patient requires a plan of care, etc). All of
15   these artifacts should draw from a common framework. As part of that framework, we should allow for
16   different data elements to be communicated as needed. In all cases, the ToC or PoC transaction should
17   support existing clinical workflows, and data overloading the recipient clinician must be avoided.
18   Ultimately, the data needs of the patient and caregivers should be considered because it is the
19   providers, patient (and/or their legal representative) that are the recipient end users of the data.


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           Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                     Use Case Development and Functional Requirements for Interoperability
                              Transition of Care and Plan of Care for LTPAC Use Case
1    The challenge of data overload cuts both ways. It is inefficient for “senders” to collect information that
2    provides no clinical benefit to the patient or guidance to the receiving clinician. It is also inefficient for
3    “receivers” to wade through extraneous information to find the relevant data elements. This challenge
4    can be met with two “filtering” processes, one for the sender and one for the receiver.

5    Among the deliverables of this initiative are datasets specific to sending and receiving sites that are
6    purpose and patient specific and which contain only those data elements required by the receiving
7    clinicians. No data elements other than these will be required. In this way, “senders” are protected             Comment [M13]: How does this affect the PAS?
8    from gathering and sending more information than is needed.

 9   The Consolidated CDA emerged from work undertaken by the ToC Initiative as described in the ToC V1.1
10   Use Case. Among other improvements, important data elements were added to the CCD document and
11   a Discharge Summary document was defined. Improvements are currently underway to enhance the C-
12   CDA to enable the interoperable exchange of Functional, Cognitive and Pressure Ulcer information that
13   is critical for the safe and efficient transfer and care of LTPAC patients. This Use Case will not assume
14   the use of the C-CDA, but will provide the necessary functional and data set guidance in order to
15   improve the capabilities of the C-CDA should that standard be adopted in the Standards Harmonization
16   phase of implementing this Use Case.

17   The challenges for transitions of care in this Use Case are:

18          Update and refine the ToC V1.1 “Core” data set that would be required in all ToC circumstances;
19          Identify the kinds of data beyond this “Core” data set needed to define generic LTPAC transfers
20           of care based initially on the HHA and SNF Nursing Home care settings;
21          To define a uniform way of structuring commonly used information;
22          To provide a robust tool-set to aid in the development and validation of conforming
23           implementations to support widespread adoption with a specific focus on LTPAC settings.
24          Providing guidance to implementers on how to utilize the data defined in patient assessments
25           (MDS 3.0 and OASIS C) to construct the transitions of care data sets.

26   The challenges for shared care as embodied in the plan of care in this Use Case are:

27          Defining the data sets and detailed data elements required to construct an interoperable plan
28           of care for the initial, interim and recertification uses of the Homecare PoC;
29          The electronic signing of the Homecare PoC by the physician to authorize the orders provided in
30           the PoC;
31          Aligning ToC and PoC data elements where possible and practical to ensure consistency and
32           reusability in implementation;
33          Providing guidance to implementers on how to utilize the data defined in patient assessments
34           (MDS 3.0 and OASIS C) to construct the plan of care data sets.


35   4.0 Value Statement
36   The standardized patient clinical summary will provide timely, accurate, and structured information at
37   the point of care to the receiving provider as well as offering enhanced clinical information to the
38   patient. The accuracy and appropriate amount (the data required for the care of the patient without
39   data overload) of clinical information will ensure that clinicians provide high quality care and patients
40   will now become more involved and be informed of their care overall leading to a patient centric


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           Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                    Use Case Development and Functional Requirements for Interoperability
                              Transition of Care and Plan of Care for LTPAC Use Case
1    approach and patient empowerment. Enhancing a patient’s ability to make well informed decisions
2    about their healthcare can be supported by the patient having access to their health information.

3    The standardized homecare health plan of care will provide timely, accurate and structured information
4    for actors involved in the creation and maintenance of the plan of care as well as informing patients
5    and/ or the patient’s care delegate.

6    Defining the minimum data elements to be exchanged and mapping them to MU specified formats will
7    facilitate standardized functionality becoming rapidly incorporated into certified EHR vendor offerings
8    and better enable providers to use the specifications in a timely manner to exchange the required
9    clinical data between care settings and with their patients.

10   For homecare providers and physicians who use EMRs, there are two major benefits from an electronic
11   exchange of the homecare Plan of Care: reducing overhead effort through greater efficiency, and
12   improving clinical outcomes through fuller collaboration.

13          Efficiency: An electronic exchange of the Plan of Care between the EMRs of the homecare
14           provider and the physician can improve efficiency for both parties. It places the Plan of Care in
15           the physician’s electronic inbox to review and act on as part of their daily workflow. It
16           eliminates the large amount of time wasted in phone tag and the frustration of the homecare
17           provider in not obtaining a timely signed order. It reduces paper and fax, and corresponding
18           manual processes. It also eliminates the need for physicians to use the disparate physician
19           portals that are currently hosted by many individual CHHAs, and are outside of the physicians’
20           EMRs and their typical daily workflow, to approve Plans of Care. The electronic exchange is
21           integrated with the EMRs that both parties are already using to automate their patient care
22           activities; it fits their preferred workflow in the most efficient way. Physicians may also find that
23           it provides documentation of their oversight of homecare patients, which is a billable activity for
24           which physicians can obtain reimbursement.

25          Collaboration: The electronic exchange of the Plan of Care may also promote collaboration by
26           supporting the timely transmission of relevant clinical information at the start of homecare and
27           as the patient’s condition changes. It enables both the physician and the homecare provider to
28           initiate changes to the homecare treatment more promptly as the patient’s needs change.
29           Because both parties are working within their EMR in this exchange, the communication occurs
30           immediately in the clinical process. For patient-centered medical homes (PCMH), not only are
31           the physician and the homecare provider the beneficiaries of this improved collaboration but
32           the whole PCMH team as well. This exchange will also promote collaboration in future care
33           delivery models such as Accountable Care Organizations (ACO) where care coordination and
34           care management are essential.

35   Furthermore, building on the use of electronic health records by exchanging data electronically to
36   increase workflow efficiencies and clinician collaboration, thereby improving patient outcomes, will
37   contribute to an overall decrease in healthcare costs in the years to come. Cost savings may come from
38   avoided medical errors, decreased likelihood of harmful drug-to-drug interactions, and improved




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            Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                     Use Case Development and Functional Requirements for Interoperability
                                Transition of Care and Plan of Care for LTPAC Use Case
1    transitions of care, as records would contain information from all patient encounters within the medical
2    system.2 [need citation from Homecare PoC Use Case]


3    5.0 Use Case Assumptions
4    Assumptions for this Use Case are the following:

 5              Transitions of Care to and from LTPAC are setting to setting transfers, each involving the
 6               contributions of one or more providers to complete the required dataset. This requires another
 7               level of organization that provides not only to capability of transferring and receiving clinical
 8               summaries, but also the capability to construct them from inputs from the required participants.
 9              A provider is an individual clinician in a care delivery setting who submits or receives the
10               transfer of the clinical message for the purposes of delivering care. A provider organization is
11               engaged in or supports the delivery of healthcare and includes hospitals, acute care facilities,
12               rehabilitation, nursing care facilities and ambulatory facilities and home health agencies.                                                         Comment [M14]: Recommend re-using the
13              The Transferring or Referring provider or Provider Organization has an EHR system or other                                                          description of provider organizations from page 14 .
                                                                                                                                                                     Includes Hospitals (including short-term acute care
14               computer system capable of producing a structured summary document with, at a minimum,                                                              hospitals and specialty hospitals (e.g., long-term
15               the data electronically captured to support their respective organizational reporting                                                               care hospitals, rehabilitation facilities, and
                                                                                                                                                                     psychiatric hospitals)), Ambulatory Centers,
16               requirements, e.g., MDS or 485 as properly coded data elements; and can be exchanged with                                                           Provider Practices, Nursing Homes, Home and
17               another EHR system or PHR system.                                                                                                                   Community-Based Service Providers (e.g., Home
18              The receiving facility, if LTPAC, has the capability of receiving the structure transmission of data                                                Health Agencies, Hospice, Adult Day Care Centers,
                                                                                                                                                                     etc. ), and human and social service providers (e.g.,
19               into their local EHR system and the ability to reuse that structured data to populate the MDS 3.0                                                   transportation).
20               and/ or their OASIS C Patient Assessment Instrument.                                                                                                Comment [kc15]: For M11 – can we reference
21              The EHR, other computer system or PHR system is capable of ensuring that content of the                                                             the table in section 2.6?
22               Summary Record (as exchanged) maintains its fidelity to source, as well as assured identity,                                                        Comment [M16]: Shouldn’t this read
23               provenance, completeness, audit/traceability, full context, along with permissions and                                                              “Homecare Plan of Care”?
24               qualifications                                                                                                                                      Comment [M17]: I think it is premature to
25              The transmission of data may occur directly between network partners or via HISPs or Health                                                         identify the reuse of transmitted data in population
                                                                                                                                                                     of MDS/OASIS.
26               Information Exchanges as data may be transmitted to multiple EHRs, HIEs, repositories and
27               providers
28                   a. Some exchanges may require HISP to HISP connectivity
29              The providers participating in direct information exchanges and in HISP mediated exchange
30               services have established network and policy infrastructure to enable consistent, appropriate,
31               and accurate information exchange across clinical systems, EHRs, PHRs, data repositories (if
32               applicable) and locator services. This includes, but is not limited to:
33                    Methods to identify and authenticate users
34                    Methods to identify and determine providers of care
35                    Methods to enforce data access authorization policies
36              Security and privacy policies, procedures and practices are commonly implemented to support
37               acceptable levels of patient privacy and security; i.e. HIPAA, HITECH and EHR certification
38               criteria
39              The Patient has and uses a PHR or has access to portal.
40              At least two separate EHR systems maintaining a “synchronized” plan of care – Home Health
41               Agency and PCP/Medical Home ;

     2 Randall Brown, “Strategies for Reigning in Medicare Spending Through Delivery System Reforms: Assessing the Evidence and Opportunities,” Paper prepared for
     The Henry J. Kaiser Family Foundation, September 2009. p. 4.


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             Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                      Use Case Development and Functional Requirements for Interoperability
                                Transition of Care and Plan of Care for LTPAC Use Case
1        •    Synchronization interval and/or events are defined - Rules for emergent, routine, periodic;
2        •    After initiation of the plan of care and replication in separate EHR systems, incremental updates,
3             based on interim changes to PoC, are sent;
4        •    Medical and nursing orders are maintained in the plan of care;                                          Comment [M18]: This is not necessarily a true
                                                                                                                      statement for NHs.
5        •    Goals are defined and assessments and observations are made in the plan of care.
                                                                                                                      Comment [kc19]: M15 – Qualify with HPoC?
6

7    The HISP providing the technical exchange services has established network and policy infrastructure to
8    enable consistent, appropriate, and accurate information exchange across clinical systems, EHRs, PHRs,
9    data repositories (if applicable) and locator services. This includes, but is not limited to:

10           Methods to identify and authenticate users
11           Methods to identify and determine providers of care
12           Methods to enforce data access authorization policies
13           Security and privacy policies, procedures and practices are commonly implemented to support
14            acceptable levels of patient privacy and security; i.e. HIPAA, HITECH and EHR certification
15            criteria
16           The Patient has and uses a PHR
17           The transmission of data may occur via HISPs or Health Information Exchanges as data may be
18            transmitted to multiple EHRs, HIEs and providers
19           Some exchanges may require HISP to HISP connectivity                                                    Comment [M20]: Is this a repeat of bullets 6 and
                                                                                                                      7 above?
20                                                                                                                    Comment [kc21]: Yes, looks like we can remove
                                                                                                                      this section.
21   Appendix C provides more details on Privacy and Security assumptions.


22   APPENDICES
23   Appendix A: Related Use Cases
24           AHIC Consultations and Transfers of Care
25           AHIC Consumer Empowerment; Consumer Access to Clinical Information
26           AHIC Common Data Transport
27           AHIC Clinical Notes Detail
28           AHIC Personalized Healthcare
29           NHIN Direct Primary care provider refers patient to specialist including summary care record
30           NHIN Direct Primary care provider refers patient to hospital including summary care record
31           NHIN Direct Specialist sends summary care information back to referring provider
32           NHIN Direct Hospital sends discharge information to referring provider

33   Appendix B: Previous Work Efforts Related to Clinical Information Exchange
34           Health Information Technology Standards Panel Specification IS03: The Consumer
35            Empowerment and Access to Clinical Information via Networks Interoperability Specification
36            defines specific standards needed to assist patients in making decisions regarding care and
37            healthy lifestyles (i.e., registration information, medication history, lab results, current and

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            Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                     Use Case Development and Functional Requirements for Interoperability
                               Transition of Care and Plan of Care for LTPAC Use Case
 1           previous health conditions, allergies, summaries of healthcare encounters and diagnoses). This
 2           Interoperability Specification defines specific standards needed to enable the exchange of such
 3           data between patients and their caregivers via networks.
 4          Health Information Technology Standards Panel Specification IS09: The Consultations and
 5           Transfers of Care Interoperability Specification describe the information flows, issues and
 6           system capabilities that apply to a provider requesting and a patient receiving a consultations
 7           from another provider.
 8          HITSP Information Technology Standards Panel Specification C32: The Summary Documents
 9           Using HL7 Continuity of Care Document (CCD) Component describes the document content
10           summarizing a consumer's medical status for the purpose of information exchange. The content
11           may include administrative (e.g., registration, demographics, insurance, etc.) and clinical
12           (problem list, medication list, allergies, test results, etc) information. This Component defines
13           content in order to promote interoperability between participating systems such as Personal
14           Health Record Systems (PHRs), Electronic Health Record Systems (EHRs), Practice Management
15           Applications and others.
16          Health Information Technology Standards Panel Specification C83: The CDA Content Modules
17           Component defines the content modules for document based HITSP constructs utilizing clinical
18           information. These Content modules are based on IHE PCC Technical Framework Volume II,
19           Release 4. That technical framework contains specifications for document sections that are
20           consistent with all implementation guides for clinical documents currently selected for HITSP
21           constructs. View the most current version as HTML
22          Health Information Technology Standards Panel Specification IS107: This Interoperability
23           Specification consolidates all information exchanges and standards that involve an EHR System
24           amongst the thirteen HITSP Interoperability Specifications in place as of the February 13, 2009
25           enactment of the American Recovery and Reinvestment Act (ARRA). This Interoperability
26           Specification is organized as a set of HITSP Capabilities, with each Capability specifying a
27           business service that an EHR system might address in one or more of the existing HITSP
28           Interoperability Specifications (e.g., the Communicate Hospital Prescriptions Capability supports
29           electronic prescribing for inpatient prescription orders)
30          Health Level 7: The CDA Release 2.0 provides an exchange model for clinical documents (such as
31           discharge summaries and progress notes) - and brings the healthcare industry closer to the
32           realization of an electronic medical record. By leveraging the use of XML, the HL7 Reference
33           Information Model (RIM) and coded vocabularies, the CDA makes documents both machine-
34           readable - so they are easily parsed and processed electronically - and human-readable - so they
35           can be easily retrieved and used by the people who need them. CDA documents can be
36           displayed using XML-aware Web browsers or wireless applications such as cell phones. While
37           Release 2.0 retains the simplicity of rendering and clear definition of clinical documents
38           formulated in Release 1.0 (2000), it provides state-of-the-art interoperability for machine-
39           readable coded semantics. The product of 5 years of improvements, CDA R2 body is based on
40           the HL7 Clinical Statement model, is fully RIM-compliant and capable of driving decision support



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           Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                   Use Case Development and Functional Requirements for Interoperability
                            Transition of Care and Plan of Care for LTPAC Use Case
1           and other sophisticated applications, while retaining the simple rendering of legally-
2           authenticated narrative.

3    Appendix C: Privacy and Security Assumptions
4    Security attributes includes capabilities needed to establish trust between systems, provide
5    confidentiality while in-transit, ensure authenticity of the data, and ensure that only authorized
6    individuals have access to the data.

     Feature                                                     Feature Applicability
       Audit Logging                                                                        X
       Authentication (Person)                                                              X
       Authentication (System)                                                              X
       Data Integrity Checking                                                              X
       Error Handling                                                                       X
       HIPAA De-Identification                                                              X
       Holding Messages
       Non-repudiation                                                                      X
       Pseudonymize and Re-Identify
       Secure Transport                                                                     X
       Transmit Disambiguated Identities                                                    X
       User Login                                                                           X
7                       Table 19: Common Transactions (not displayed as part of the sequence diagram)

 8   Appendix D: Glossary
 9   These items are included to clarify the intent of this use case. They should not be interpreted as
10   approved terms or definitions but considered as contextual descriptions. There are parallel activities
11   underway to develop specific terminology based on consensus throughout the industry.

12   Access Logs: An integrated view of who has accessed the consumer/patient’s health information for the
13   purposes of direct or indirect patient care.

14   Acute Care: Treatment for a short period of time in which the patient is treated for a brief episode of
15   illness. Acute Care is generally associated with care in a short term facility which is usually a non-
16   emergency department setting.

17   AHIC: American Health Information Community; a federal advisory body chartered in 2005, serving to
18   make recommendations to the Secretary of the U.S. Department of Health and Human Services in
19   regards to the development and adoption of health information technology.

20   Ancillary Entities: Organizations that perform auxiliary roles in delivering healthcare services. They may
21   include diagnostic and support services such as laboratories, imaging and radiology services, and
22   pharmacies that support the delivery of healthcare services. These services may be delivered through
23   hospitals or through free-standing entities.

24   Care Coordination: Functions that help ensure that the patient’s needs and preferences for health
25   services and information sharing across people, functions, and sites are met over time.


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           Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                    Use Case Development and Functional Requirements for Interoperability
                              Transition of Care and Plan of Care for LTPAC Use Case
1    Care Coordinators: Individuals who support clinicians in the management of health and disease
2    conditions. These can include case managers and others.

3    Clinical Support Staff: Individuals who support the workflow of clinicians.

4    Clinicians: Healthcare providers with patient care responsibilities, including physicians, advanced
5    practice nurses, physician assistants, nurses, psychologists, pharmacists, and other licensed and
6    credentialed personnel involved in treating patients.

7    Consultation: Meeting of two or more clinicians to evaluate the nature and progress of disease in a
8    particular patient and to establish diagnosis, prognosis, and therapy.

 9   Consumers: Members of the public that include patients as well as caregivers, patient advocates,
10   surrogates, family members, and other parties who may be acting for, or in support of, a patient
11   receiving or potentially receiving healthcare services.

12   Electronic Health Record (EHR): An electronic, cumulative record of information on an individual across
13   more than one healthcare setting that is collected, managed, and consulted by professionals involved in
14   the individual's health and care. This EHR description encompasses similar information maintained on
15   patients within a single care setting (a.k.a., Electronic Medical Record (EMR)).

16   Electronic Health Record (EHR) System Suppliers: Organizations which provide specific EHR solutions to
17   clinicians and patients such as software applications and software services. These suppliers may include
18   developers, providers, resellers, operators, and others who may provide these or similar capabilities.

19   Geographic Health Information Exchange/Regional Health Information Organizations: A multi-
20   stakeholder entity, which may be a free-standing organization (e.g., hospital, healthcare system,
21   partnership organization) that supports health information exchange and enables the movement of
22   health-related data within state, local, territorial, tribal, or jurisdictional participant groups. Activities
23   supporting health information exchanges may also be provided by entities that are separate from
24   geographic health information exchanges/Regional Health Information Organizations including
25   integrated delivery networks, health record banks, and others.

26   Health Information Exchange (HIE): An electronic network for exchanging health and patient
27   information among healthcare delivery organizations, according to specific standards, protocols, and
28   other agreed criteria. These functional capabilities may be provided fully or partially by a variety of
29   organizations including free-standing or geographic health information exchanges (e.g., Regional Health
30   Information Organizations (RHIOs)), integrated care delivery networks, provider organizations, health
31   record banks, public health networks, specialty networks, and others supporting these capabilities. This
32   term may also be used to describe the specific organizations that provide these capabilities such as
33   RHIOs and Health Information Exchange Organizations.

34   Healthcare Payers: Insurers, including health plans, self-insured employer plans, and third party
35   administrators, providing healthcare benefits to enrolled members and reimbursing provider
36   organizations.

37   HITSP: The American National Standards Institute (ANSI) Healthcare Information Technology Standards
38   Panel; a body created in 2005 in an effort to promote interoperability and harmonization of healthcare


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           Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                    Use Case Development and Functional Requirements for Interoperability
                              Transition of Care and Plan of Care for LTPAC Use Case
1    information technology through standards that would serve as a cooperative partnership between the
2    public and private sectors.

3    Laboratories: A laboratory (often abbreviated lab) is a setting where specimens are sent for testing and
4    analysis are resulted, and then results are communicated back to the requestor. The types of
5    laboratories may include clinical/medical, environmental, and veterinarian, and may be both private
6    and/or public.

 7   ONC: Office of the National Coordinator for Health Information Technology; serves as the Secretary’s
 8   principal advisor on the development, application, and use of health information technology in an effort
 9   to improve the quality, safety, and efficiency of the nation's health through the development of an
10   interoperable harmonized health information infrastructure.

11   Patients: Members of the public who receive healthcare services. For hospice providers, the patient and
12   family are considered a single unit of care. Synonyms used by various healthcare fields include client,
13   resident, customer, patient and family unit, consumer, and healthcare consumer.

14   Personal Health Record: A health record that is initiated and maintained by an individual. An ideal PHR
15   would provide a complete and accurate summary of the health and medical history of an individual by
16   gathering data from many sources and making this information accessible online to anyone who has the
17   necessary electronic credentials to view the information.

18   Pharmacies: Entities that exist that are experts on drug therapy and are the primary health professionals
19   who optimize medication use to provide patients with positive health outcomes

20   Provider: An individual clinician in a care delivery setting who requests or accepts the transfer of the
21   clinical summary for the purposes of delivering care.

22   Provider Organizations: Organizations that are engaged in or support the delivery of healthcare. These
23   organizations could include hospitals, ambulatory clinics, long-term care facilities, community-based
24   healthcare organizations, employers/occupational health programs, school health programs, dental
25   clinics, psychology clinics, care delivery organizations, pharmacies, home health agencies, hospice care
26   providers, and other healthcare facilities.

27   Registries: Organized systems for the collection, storage, retrieval, analysis, and dissemination of
28   information to support health needs. This also includes government agencies and professional
29   associations which define, develop, and support registries. These may include emergency contact
30   information/next of kin registries, patient registries, disease registries, etc.

31   Appendix E. References
32          American Health Information Community; AHIC;
33           www.hhs.gov/healthit/healthnetwork/background
34          The American National Standards Institute (ANSI) Healthcare Information Technology Standards
35           Panel; HITSP; www.HITSP.org
36          Health Level Seven; HL7; www.HL7.org
37          Meaningful Use Final Rule; Dept of Health and Human Services;
38           www.edocket.access.gpo.gov/2010/pdf/2010-17207.pdf


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        Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                Use Case Development and Functional Requirements for Interoperability
                           Transition of Care and Plan of Care for LTPAC Use Case
1       Nationwide Health Information Network; NHIN;
2        www.hhs.gov/healthit/healthnetwork/background
3       The ONC-SI-UC-Simplification Spreadsheet (Current Version)
4       http://wiki.siframework.org/Cross+Initiative+-+Use+Case+Simplification+SWG

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         Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
                Use Case Development and Functional Requirements for Interoperability
                         Transition of Care and Plan of Care for LTPAC Use Case
1   Appendix F. Sample CMS 485 Form




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                Use Case Development and Functional Requirements for Interoperability
                         Transition of Care and Plan of Care for LTPAC Use Case




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         Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
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                         Transition of Care and Plan of Care for LTPAC Use Case




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