PDMP & Health IT Integration All-Hands Meeting

1. PDMP & Health IT IntegrationAll-Hands Meeting January 7th, 2014

2. Meeting Etiquette From S&I Framework to Participants: Hi everyone: remember to keep your phone on mute  NOTE: This meeting is being recorded and will be posted on the Meeting Artifacts Wiki page after the meeting • Remember: If you are not speaking keep your phone on mute • Do not put your phone on hold – if you need to take a call, hang up and dial in again when finished with your other call • Hold = Elevator Music = very frustrated speakers and participants • This meeting, like all of our meeting is being recorded • Another reason to keep your phone on mute when not speaking • Feel free to use the “Chat” feature for questions, comments or any items you would like the moderator or participants to know.

3. Agenda

4. General Announcements Note: Please check the meeting schedule weekly to get the most up-to-date meeting information • The PDMP & Health IT Integration Initiative meets weekly on Tuesdays from 12-1pm. • For the most up-to-date schedule check the“Weekly Meetings” Section of the PDMP & Health IT Integration Wiki Homepage:http://http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Homepage

5. Join the Initiative We encourage all members to “sign up” or join the initiative. By joining this ensures you stay up-to-date with the work being done, communications and any initiative activities. Simply complete the Join Form on the Join Wiki Page:http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Join+the+Initiative

6. The Standards & Interoperability (S&I) Framework: • Creates a collaborative, coordinated, incremental standards process. • Is guided by the ONC (with input from Federal Advisory Committees). • Is enabled and led by the an open community of industry participants who are interested in solving real-world problems. • Each S&I Initiative focuses on narrowly-defined, broadly applicable challenge, tackled through a rigorous development cycle, and provides input to Federal Advisory Committees for consideration.

7. S&I Framework Phases & PDMP & Health IT Integration Activities We are Here

8. PDMP Project Timeline Nov 13 Jan 14 July 14 Mar 14 June 14 Kick-off (11/14) Initiative End Use Case Kick Off Use Case Consensus Standards and Harmonization Kick Off Pilot Kick Off Pre-Discovery, Call for Participation Discovery Implementation Pilot User Stories, Use Cases, Functional Requirements Standards Gap Analysis Harmonized Specifications Reference Model Implementation & Validation Technology Evaluations

9. S&I FrameworkPrescription Drug Monitoring Program & Health IT Integration Initiative Use Case & Functional Requirements Kickoff Meeting January 7, 2014 9

10. Agenda

11. Use Case Development Objectives • Engage Stakeholders as Committed Members, Invite Experts, or Interested Parties in the creation of a Use Case  This is you all! • Identify Scenarios and User Stories that address real-world problems • Keep it simple • Focus on the business and functional requirements: Focus on “what” the requirements should be rather than “how” • Create a finalized Use Case that demonstrates value and supports the proposed goals and success criteria for the Initiative • Publish a finalized Use Case that contains necessary content, supported by artifacts, to enable Harmonization and subsequent S&I Framework efforts to occur

12. Use Case OutlineTailored for each Initiative • 10.0 Scenario: Workflow • 10.1 User Story 1, 2, x, … • 10.2 Activity Diagram • 10.2.1 Base Flow • 10.2.2 Alternate Flow (if needed) • 10.3 Functional Requirements • 10.3.1 Information Interchange Requirements • 10.3.2 System Requirements • 10.4 Sequence Diagram • 11.0 Dataset Requirements • 12.0 Risks, Issues and Obstacles • Appendices • Privacy and Security Considerations • Related Use Cases • Previous Work Efforts • References • 1.0 Preface and Introduction • 2.0 Initiative Overview • 2.1 Initiative Challenge Statement** • 3.0 Use Case Scope • 3.1 Background** • 3.2 In Scope • 3.2 Out of Scope • 3.3 Communities of Interest (Stakeholders)** • 4.0 Value Statement** • 5.0 Use Case Assumptions • 6.0 Pre-Conditions • 7.0 Post Conditions • 8.0 Actors and Roles • 9.0 Use Case Diagram ** Leverage content from Charter

13. Review of Key Use Case SectionsAssumptions, Pre-conditions and Post-conditions Assumptions • Outlines what needs to be in place to meet or realize the requirements of the Use Case • These points are more functional in nature and state the broad overarching concepts related to the Initiative. • The Use Case assumptions will serve as a starting point for subsequent harmonization activities Pre Conditions • Describes the state of the system, from a technical perspective, that must be true before an operation, process, activity or task can be executed. • It lists what needs to be in place before executing the information exchange as described by the Functional Requirements and Dataset requirements. Post Conditions • Describes the state of the system, from a technical perspective, that will result after the execution of the operation, process activity or task.

14. Review of Key Use Case SectionsUse Case Diagrams Example: Transitions of Care • Conceptually represents the Business Actors interacting with the Use Case and the User Stories • Provides a pictorial representation of the environment where the exchange takes place • Characterizes the types of interactions that an actor has with a specific system • Shows the association and interaction between the business actors and the Use Case • It provides an overview of the actors (users or external systems) and the interactions between them

15. Review of Key Use Case SectionsDefining the Actors • This section of the Use Case outlines the business actors that are participants in the information exchange requirements for each scenario. A business actor is a person or organization that directly participates in a scenario. • The business actor must use a system to perform the functions and to participate in the information interchange. The system or system actor has roles (send, receive, publish, subscribe or in some cases display) and actions which involve exchanging content. Please see the table below for an example of these designations. Example

16. Review of Key Use Case SectionsScenarios • The scenario is a comprehensive description of the actors, interactions, activities, and requirements associated with the information exchange • Scenarios pertain to supporting the health information exchange and describing key flows, and they are supplemented by User Stories • Example: Specialist requests a patient’s Clinical Care Summary from Primary Care Provider (PCP) Scenario 1 Scenario 2 User Story 2 User Story 1 User Story 1 User Story 2

17. Review of Key Use Case SectionsUser Story • User Stories describe the real world application as an example or instantiation of the Scenario • User Stories summarize the interaction between the actors of the Use Case, and specify what information is exchanged from a contextual perspective • These interactions are further described in subsequent sections. Historically, user stories have been utilized to provide clinical context • Example Scenario (from previous slide): Specialist requests a patient’s Clinical Care Summary from Primary Care Provider (PCP) • Example User Story: A Specialist receives a referral and requires more information to treat the patient properly at the point of care. Using an EHR System, the Specialist sends a request to the PCP for the patient’s Clinical Care Summary. The PCP successfully receives the requests, understands the requests, and sends the patient’s Clinical Care Summary back to the Specialist via the EHR System. The Specialist successfully receives the patient information, understands it, and makes an informed decision that can provide better quality of care to the patient.

18. Review of Key Use Case SectionsActivity Diagram • An Activity Diagram is a special form of a state transition diagram in which all or most of the states are activity states or action states • The Activity Diagram illustrates the Use Case flows graphically, and represents the flow of events and information between the actors • It also displays the main events/actions that are required for the data exchange and the role of each system in supporting the change

19. Review of Key Use Case SectionsFunctional Requirements • Functional Requirements identify the capabilities a system in a role must have in order to enable interoperable exchange of the healthcare data of interest • They provide a detailed breakdown of the requirements in terms of the intended functional behaviors of the application • The Functional Requirements include: • Information Interchange Requirements • System Requirements • The Information Interchange Requirements define the system’s name and role. They also specify the actions associated with the actual transport of content from the sending system to the receiving system • System Requirements include the requirements internal to the system necessary to participate successfully in the transaction. System requirements may also detail a required workflow that is essential to the Use Case

20. Review of Key Use Case SectionsSequence Diagram • A Sequence Diagram is primarily used to show the interactions between objects in the sequential order that they occur • This representation can make it easy to communicate how the exchange works by displaying how the different components interact • The primary use of the diagram is in the transition from requirements expressed as use cases to the next and more formal level of refinement • Note: Horizontal lines are used to identify the specific activity between the systems

21. Review of Key Use Case SectionsDataset Requirements & Issues, Risks& Obstacles Dataset Requirements • Include the data elements and data element sets that will be available within the message or document. Each data element included is necessary for some aspect of the Use Case; however, the requirements do not specify exactly how they may be used together. All data element sets may contain multiple data elements unless otherwise stated. • The identification of data elements forms the foundation for harmonization activities. The data elements identified in the Use Case set constraints on the contents of documents and messages. Issues Risks and Obstacles • Lists the concerns that might interfere with meeting the requirements of the Use Case. • Note: This list takes into consideration risks outlined in the Charter

22. S&I Community Enabling Toolkit (CET)Use Case Overview

23. Prescription Drug Monitoring Program & Health IT Integration Use Case Discussion 23

24. Agenda

25. PDMP & HIT Integration InitiativeProposed Use Case & Functional Requirements Development Timeline

26. PDMP & HIT Integration – Use Case Assumptions Definitions Healthcare Professional- A medical practitioner or provider of care who has legal authorization to access prescription drug data for patients at the point of care to make informed clinical decisions and appropriate treatment recommendations This may include: Prescribers, dispensers, nurses, etc. Health IT System – An information system that is used by a Healthcare Professional to collect and store patient information including demographics, medicine, etc. (i.e. EHR, HIE, Pharmacy System) Health IT system is capable of querying a PDMP All Healthcare Professionals have appropriate legal authority based on state regulations to request and receive information from state PDMP Healthcare Professionals accessing the PDMP follow state guidelines as appropriate, including any privacy and security requirements as required by each individual state PDMP authority The PDMP returns high positive matches to the Healthcare Professional1 The Healthcare Professional accesses information that already exists within the PDMP at the time of querying 1Question for Community: What are the responses you receive when querying a PDMP? 26

27. PDMP & HIT Integration – In and Out of Scope Out of Scope • Defining the trigger event for how the PDMP is queried or initiated by the user (e.g., hyperlink while ordering, pressing a button, automatic trigger, etc.)** • Addressing delegation of rights to individuals not legally authorized to prescribe medications (this is an implementation specific decision and may vary by implementation and pilot sites)** • Third party access - (this is an implementation specific decision and may vary by implementation, pilot sites and state statues and law)** • Reporting patient prescription information from dispensers to state PDMP • Policy-based decisions on how PDMPs are managed, accessed, and updated that vary from state to state • Timeliness of PDMP: Currency of Data • Storing query response from PDMP • Health IT system’s structure of display for the query response In Scope • Connecting PDMPs to Health IT systems using existing standards; (technical mechanism for actual exchange of data)** • If standards do not exist, identifying the gap in the current standards and working with the Standards Organizations (SDOs) to address the gaps** (Refers to harmonization activity) • Improving effective and efficient access to PDMP data by Healthcare Professionals** • Health IT system has ability to view query response from PDMP • Healthcare Professional querying PDMP for a known patient through a Health IT system • Healthcare Professional querying a state PDMP connected to the same hub as the state they are located in • Safety notifications/ automated alerts from PDMP • Define standard set of data elements used to submit queries each time • Define system /technical requirements for Healthcare Professionals to be able to access patient information already stored in a PDMP • Accessing a PDMP through a Health IT system (i.e. EHR system) instead of another portal • Define system/technical requirements that allow applications to access data in a consistent manner across the local Health IT system • Method of extraction **Leveraged from Charter

28. Generic Scenario & Context Diagram PDMP & HIT Integration Use Case Scope Pre-Step: Healthcare Professional logs into Health IT System 1. Sends query to state PDMP Interstate Hub Healthcare Professional receives requested information 2. PDMP sends query response AND/OR PDMP & HIT Integration Use Case Scope Pre-Step: Healthcare Professional logs into Health IT System 1. Sends query to state PDMP Healthcare Professional receives requested information 2. PDMP sends query response

29. Agenda

30. ASAP ASAP A History of Working with PDMPs American Society for Automation in Pharmacy 492 Norristown Road • Suite 160 • Blue Bell, PA 19422 610/825-7783 • 610/825-7641 (fax) • www.asapnet.org

31. A History of Working with PDMPs • First ASAP standard developed in 1995 Standard has evolved over the years, based on requests from PDMPs to: • Improve the quality of the information reported to better detect abuse and diversion. • Expand the data elements for a more complete picture of those receiving controlled substances. • Refine examples on how to submit data for specific data elements. • ASAP Workgroups average 20 or so participants. Workgroups include representation from PDMPs, system vendors, drug chains, PDMP hubs and data collection organizations. • ASAP named as the reporting standard in state PDMP legislation enacted. • Latest ASAP standard required for SAMHSA grant funding.

32. A History of Working with PDMPs 4.2, the current version, published in September 2011. Minimal changes to Version 4.1. Example: Increased field lengthsfor a few data elements based on PDMP suggestions.  4.2 not only being used by retail and outpatient pharmacies, but veterinarians and physicians dispensing from stock. 4.2 used by pharmacies to report CS Rxs written by not only physicians but veterinarians and dentists as well.  4.2 can be used for real-time reporting as well as batch reporting.

33. A History of Working with PDMPs The required data elements form the minimum data set. These are the data elements states agreed must be reported. Optional data elements can be invoked based on a state’s reporting requirements.  Examples: Some states want the species reported (animal vs. human). Some states want an ID (military ID, driver’s license, tribal ID, green card, etc.) and first and last name of person dropping off or picking up the Rx, if different from the patient, and the relationship to the patient.  Other examples: Method of payment. Date sold vs. date dispensed.

34. A History of Working with PDMPs • Zero Report Standard  In 2011 added this standard in response to industry request that we needed one way to report when no controlled substances were dispensed during the reporting period. Workgroup had representation from all the stakeholders. • Error Report Standard Also added a common data structure and minimum data set to communicate specific errors identified by a PDMP within each batch file received that must be corrected and resent.

35. A History of Working with PDMPs • ASAP Web Service Standard • Published in January 2013, to move ad hoc queries on a person of interest into the workflow of a pharmacy management system and EHR system.  • XML based.  • Supports automated polling of PDMP data to see if anyone hit the state’s threshold for triggering an unsolicited report. Would happen as a background task. • Ad hoc queries can handle reference numbers and “pick lists” where probable matches are returned to ensure selection of the correct person of interest. • Supports all the data elements in the ASAP reporting standard in order to provide states with flexibility for the information provided in a response. • Provide sample program to facilitate implementation (tested and works).  • Low cost for PDMPs to implement (a prime consideration).   • It is cost neutral — there is no transaction charge involved for a query.  • Uses NIEM tags.

36. A History of Working with PDMPs • General • All ASAP standards are made available to PDMPs and state and federal agencies at no charge. • Have established a close working relationship with state programs over the years. • Have had regular attendance at Annual Harold Rogers National Meetings over the years to stay abreast of the issues facing PDMPs and how ASAP can respond.

37. Next Steps • Review In/Out of Scope, Scenario and Assumptions sections • Next Meeting is Tuesday, January 14 from 12:00pm - 1:00pm EST • Reminder: All PDMP & HIT Integration Announcements, Meeting Schedules, Agendas, Minutes, Reference Materials, Use Case, Project Charter and general information will be posted on the PDMP Wiki page • http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Homepage

38. Preparing for 2014- Proposed January Meeting Schedule

39. Contact Information • For questions, please feel free to contact your support leads: • Initiative Coordinators: • Johnathan Coleman jc@securityrs.com • Sherry Green sgreen@namsdl.org • ONC Leads: • Mera Choi mera.choi@hhs.gov • Jennifer Frazier Jennifer.Frazier@hhs.gov • Helen Caton-Peters Helen.Caton-Peters@hhs.gov • SAMHSA Leads • Jinhee Lee Jinhee.Lee@samhsa.hhs.gov • Kate Tipping Kate.Tipping@samhsa.hhs.gov • Support Team: • Project Management: • Jamie Parker jamie.parker@esacinc.com • Ali Khan Ali.Khan@esacinc.com (Support) • Use Case Development: • Ahsin Azim Ahsin.Azim@accenturefederal.com • Presha Patel presha.patel@accenture.com • Vocabulary and Terminology Subject Matter Expert: • Mark Roche mrochemd@gmail.com

40. Questions

41. PDMP & Health IT IntegrationResources • Initiative Wiki Homepage • http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Homepage • Become a Community Member • http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Join+the+Initiative • Project Charter • http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Charter+and+Members • Standards and Interoperability(S&I) Framework • http://wiki.siframework.org/Introduction+and+Overview • S & I Calendar of Events • http://wiki.siframework.org/Calendar