1. PDMP & Health IT Integration Standards and Harmonization June 24 th, 2014

2. Agenda TopicTime Allotted General Announcements5 minutes PDMP & HITI Standards and Harmonization Summary of outcomes from Solution Planning Workgroup 6/19 Minimum dataset requirements analysis 50 minutes Next Steps/Questions5 minutes

3. PDMP Harmonization Timeline MarchAprilMayJuneJuly 3/25 Harmonization Kick-off Standards Evaluation Candidate Standards List UCR-Standards Mapping Gap Mitigation Plan Solution Planning IG Development Solution Plan Create IG Template IG Development End-to-end Review & Community Consensus (Today) 7/29 Harmonization Close

4. Week Target Date (2014) All Hands WG Meeting Tasks Review & Comments from Community via Wiki page due following Monday @ 12 noon 13/25 Harmonization Kick-Off & Process Overview Introduce: Overview of UCR-Standards Mapping Review: N/A 24/1Introduce: Candidate Standards List & UCR-Standards MappingReview: Candidate Standards List 34/8 Finalize: Candidate Standards List Review: UCR-Standards Mapping 44/15Review: UCR-Standards Mapping -4/22 Cancelled for National Rx Summit 54/29 Finalize: Outcome of UCR-Standards Mapping Introduce: Gap Mitigation Plan Review: Gap Mitigation Plan 65/6Review: Gap Mitigation Plan 75/13 Finalize: Gap Mitigation Plan Introduce: Solution Planning Workgroup Review: N/A 85/20 Review: Outcomes of Solution Planning Workgroup Introduce: Implementation Guide (IG) Template Review: Implementation Guide Template 95/27 Review: Outcomes of Solution Planning Workgroup Introduce: Minimum Dataset Requirements Review: Minimum Dataset Requirements & IG Template 10-116/3 – 6/10 Review: Outcomes of Solution Planning Workgroup & Minimum Dataset Requirements Review: Minimum Dataset Requirements 126/17 Review: Outcomes of Solution Planning Workgroup & Minimum Dataset Requirements Review: Minimum Dataset Requirements 13-156/24 – 7/8 Review: Dataset Requirements; Solution Plan Finalization; Implementation Guide Development Review: Minimum Dataset; Solution Plan; Implementation Guide Content 16-177/15 – 7/22End-to-End Community Review of Implementation GuideEnd-to-End Review of Implementation Guide 187/29Consensus Vote Harmonization Weekly Timeline

5. Review: Solution Planning Workgroup Session (6/19) Solution Plan Workflow Analysis

6. Transactions Scope FromViaTo 1a 1b  EHR Pharmacy -In-State PDMP 2a 2b  EHR Pharmacy HIE Ph. Int In-State PDMP 3a 3b  EHR Pharmacy HubIn-State PDMP 4  -Out of State PDMP 5a 5b  HIE Ph. Intermediary -Out-of-State PDMP 6  Hub-Out-of-State PDMP 7a 7b  HIE Ph. Intermediary HubIn-State PDMP 8  HubOut-of-State PDMP PMP/HITI User Stories with Alternate Workflows EHR or Ph. to In-State PMP: 1a: EHR to In-state PMP 1b: Ph. to In-state PMP 2a: EHR to In-state PMP via HIE 2b: Ph. to In-State PMP via HIE 3a: EHR to In-state PMP via Hub 3b: Ph. Intermediary to In-State PMP via Hub EHR or Ph. to Out-of-State PMP: 1a+4: EHR to out-of-state PMP via In-state PMP 1b+4: Ph.to out-of-state PMP via In-state PMP 2a+4: EHR to out-of-state PMP via HIE & In-state PMP 2b+4: Ph. to out-of-state PMP via Ph. Int & In-state PMP 2a+5: EHR to out-of-state PMP via HIE 2b+5: Ph. to out-of-state PMP via HIE 2a+7a+6: EHR to out-of-state PMP via HIE + Hub 2b+7a/7b+6: Ph to out-of-state PMP via HIE/Ph. Int + Hub 3a+4: EHR to out-of-state PMP via Hub & In-State PMP 3b+4: Ph. to out-of-state PMP via Hub & In-State PMP 1a+8: EHR to out-of-state PMP via In-State PMP & Hub 1b+8: Ph. to out-of-state PMP via In-State PMP & Hub 3a+6: EHR to out-of-state PMP via Hub 3b+6: Ph. To out-of-state PMP via Hub HIE/Ph. Interm. In-State PDMP Out of State PDMP Hub EHR or Pharmacy System 1 2 3 3 4 2 3 3 6 5 7 7 7 7 Hub 88

7. Solution Planning Work Group Approach 1. Overlay standards currently in general use per transaction - focus on transactions for integrated solutions 3. For prioritized workflow, propose solutions for harmonizing standards in order to pull PDMP information into EHR or Pharm. IT Systems synchronously 2. Document pros and cons for each proposed solution and prioritize in terms of technical feasibility Develop Technical Architecture  Can EHRs and Pharmacy ITs handle proposed Standards? Report findings to Community

8. Solution Planning Approach 1. How to take HL7 V2, NCPDP SCRIPT, ASAP and transform to PMIX Architecture-NIEM Standards? 2. What gaps have been identified to perform necessary query out of HIT specific to PDMP? 3. Define technical architecture of total solution. Variant 1: Intermediary provides translation functionality Variant 2: Translation is handled at EHR, providing mapping to PMIX from native EHR standards Variant 3: Interface engine at EHR-level provides functionality to send PMIX message derived from native EHR standards. EHR / Pharmacy EHR / Pharmacy Ph. Interm. HIE PDMP Hub PDMP Most preferred workflow Translation / Routing EHR Origin Standard: HL7 V2 (acute) NCPDP SCRIPT (ambulatory + optional acute settings) ASAP Web Services PDMP Standard PMIX Pharmacy Origin Standard: HL7 V2 (in hospital) NCPDP SCRIPT (large retail pharmacies) ASAP Web Services

9. Begin detailing solution and technical details (standards) Prioritize EHR/Pharm  Hub Solution Prioritize EHR/Pharm  Hub Solution Develop holistic solutions for Hub, Intermediary, and Direct workflows Leverage Hub Solution for EHR/Pharm  Intermediary workflow guidance Defer direct connection workflow model due to limited scalability and restriction of interstate data sharing Develop IG content based on PDMP Hub solution Develop IG content based on PDMP Intermediary solution Develop IG content based on PDMP Direct solution Deferment does not equate to elimination of workflows from inclusion in future solution plans and iterations/updates to the Implementation Guide

10. EHR Prioritization #Workflow ModelPrioritizationJustification 3a EHR to PDMP Hub to PDMPs High Capable of facilitating interstate data exchange with reduced complexity PDMP Hubs are compliant with state regulations regarding access and routing of PDMP-data Future hub capabilities support efficient workflow model Interstate data exchange drives organized data sourcing and in turn, is critical element to most interoperable state of data flow 2a EHR to Intermediary to PDMP (PDMP Hub to PDMP) Medium Scalable Provides flexibility in accommodating multiple standards Ability to leverage existing connections for clinical data Increased complexity due to additional connections and implication of policy/regulations on third party use 1aEHR to In-State PDMPLow Supports unique implementations and PDMP infrastructure Restrictive in expanding efficient interstate data sharing Reduced complexity, though not as highly scalable Perhaps necessary where policy hinders use of third parties for translation/transformation Pharmacy IT Prioritization #Workflow ModelPrioritizationJustification 3b Pharmacy IT to PDMP Hub to PDMPs High Same as transaction 3a Existing pilots established using workflow 2b Pharmacy IT to Intermediary to PDMP (PDMP Hub to PDMP) Medium Same as transaction 2a Concern regarding cost to participate May allow for future-state PDMP-data access through third parties 1b Pharmacy IT to In- State PDMP Low Same as transaction 1a Pharmacies typically leverage third party for medication history Limited perceived interest from user community

11. Use of an Intermediary: An entity or service that accepts an electronic transaction from another organization and electronically routes the transaction to a receiving entity. A switch/intermediary may perform value added services including detailed editing/messaging of input/output of data for validity and accuracy and translating data from one format to another. Intermediary Model EHR  HIE / Pharm. Intermediary / Switch / Clinical Exchange Network  In-State PDMP EHR  HIE / Pham. Intermediary / Switch/ Clinical Exchange Network  PDMP Hub  PDMPs Pharmacy  Pharm Int. / Switch / Clinical Exchange Network  In-State PDMP Pharmacy  Pharm Int. / Switch / Clinical Exchange Network  PDMP Hub  PDMPs Intermediaries EHR  Intermediary EHR  Intermediary  In-state PDMP EHR  Intermediary  Hub  PDMPs EHR  Intermediary Pharmacy  Intermediary  In-state PDMP Pharmacy  Intermediary  Hub  PDMPs

12. Minimum Required Data Elements Analysis - Status Solution Plan Workgroup Transaction Analysis Data CategoryTransaction ModeStatusCommunity Determination Patient Information RequestCompleteFirst Name Last Name Date of Birth ResponseTo Be Completed GeneralRequestIn ProgressRequest Date/Timestamp Requester Location ResponseTo Be Completed Authorized UserRequestCompleteAuthentication Credentials Type of User Prescription Information ResponseTo Be Completed PrescriberResponseTo Be Completed DispenserResponseTo Be Completed

13. Data Element Analysis

14. Implementation Guide – Data Elements and Attributes

15. Data Requirements Analysis - PDMP & HITI Use Case Request Transaction Data Elements GeneralAuthorized UserPatient 1.Request Date 2.Request Timestamp 3.State of Request 4.Requestor Location 5.Requested State(s) [if applicable] 6.Authenticator 7.System authentication 8.Initiating requestor’s routing ID 9.Responder ID 10.Message ID 11.Requestor’s Internal Patient ID 12.Start Date 13.End Date 1.First Name 2.Last Name 3.Generational Suffix [if applicable] 4.Address Information 5.Optional Address Information 6.City Address 7.State Address 8.ZIP Code Address 9.Email Address 10.Phone Number 11.Authentication Credentials [DEA, NCPDP/NABP Provider ID, NPI, License #, Delegate ID 12.Type of User 1.First Name 2.Last Name 3.Address Information 4.Optional Address Information 5.City Address 6.State Address 7.ZIP Code Address 8.Phone Number 9.Patient Gender 10.Country 11.Date of Birth 12.Identification Qualifier of Patient Identifier 13.Identification of Patient

16. Data Requirements Analysis - PDMP & HITI Use Case Response Transaction Data Elements GeneralPatientPrescriptionPrescriberDispenser 1.Response Date 2.Response Timestamp 3.Response Time 4.State of Response 5.Response Identifier 6.Message ID 7.Summary 8.Create Time 9.Intended Recipient 10.Status of Request 1.First Name 2.Last Name 3.Address Information 4.Optional Address Information 5.City Address 6.State Address 7.Zip Code Address 8.Country 9.Date of Birth 10.Identification Qualifier of Patient Identification 11.Identification of Patient 12.PDMP Patient Reference Number 13.Gender Code 14.Species Code 15.Phone Number 1.Name of Drug 2.Strength 3.Form 4.Quantity Dispensed 5.Days Supply Dispensed 6.Date Written 7.Refills Authorized 8.Refill Number 9.Partial Fill 10.Prescription Number 11.Date Prescription Filled 12.Date Prescription Sold/Dispensed 13.Drug Identifier 14.Payment Method 1.First Name 2.Last Name 3.Address Information 4.Optional Address Information 5.City Address 6.State Address 7.Zip Code Address 8.Phone Number 9.DEA # 10.Authentication Credentials 11.PDMP Prescriber Reference # 1.Pharmacy or Dispensing Prescriber’s Name 2.Address Information 3.Optional Address Information 4.City Address 5.State Address 6.ZIP Code Address 7.Phone Number 8.DEA # 9.NCPDP/NABP Provider ID 10.NPI 11.PDMP Dispenser Reference #

17. Consolidated Standard Data Set– PDMP & HITI Use Case PDMP & HITI Use Case Data Elements GeneralPatientPrescriptionAuthorized User* 1.Request Date 2.Request Timestamp 3.State of Request 4.Requestor Location 5.Requested State(s) [if applicable] 6.Authenticator 7.System authentication 8.Initiating requestor’s routing ID 9.Responder ID 10.Message ID 11.Requestor’s Internal Patient ID 12.Start Date 13.End Date 14.Response Date 15.Response Timestamp 16.Response Time 17.State of Response 18.Response Identifier 19.Summary 20.Create Time 21.Intended Recipient 22.Status of Request 1.First Name 2.Last Name 3.Address Information 4.Optional Address Information 5.City Address 6.State Address 7.Zip Code Address 8.Country 9.Date of Birth 10.Identification Qualifier of Patient Identification 11.Identification of Patient 12.PDMP Patient Reference Number 13.Gender Code 14.Species Code 15.Phone Number 1.Name of Drug 2.Strength 3.Form 4.Quantity Dispensed 5.Days Supply Dispensed 6.Date Written 7.Refills Authorized 8.Refill Number 9.Partial Fill 10.Prescription Number 11.Date Prescription Filled 12.Date Prescription Sold/Dispensed 13.Drug Identifier 14.Payment Method 1.First Name 2.Last Name 3.Address Information 4.Optional Address Information 5.City Address 6.State Address 7.Zip Code Address 8.Phone Number 9.DEA # 10.Authentication Credentials 11.PDMP Prescriber Reference # 12.Pharmacy or Dispensing Prescriber’s Name 13.NCPDP/NABP Provider ID 14.NPI 15.PDMP Dispenser Reference # 16.Type of user *Includes Physician and Dispenser

18. Standard Data Set– MITRE WG Recommendation MITRE Standard Data Elements PatientPrescriberDispenserPrescription 1.First name 2.Last name 3.Street address 4.City 5.State 6.ZIP code 7.Date of birth 8.Identification (ID) qualifier and/or patient identifier (situational) 9.Gender code (situational) 10.Species code (situational) 11.Phone number (situational) 1.First name 2.Last name 3.Street address 4.City 5.State 6.ZIP code 7.Phone number (situational) 8.Drug Enforcement Agency (DEA) number (situational) 1.Pharmacy or dispensing prescriber name 2.Street address 3.City 4.State 5.ZIP code 6.Phone number (situational) 7.DEA number (situational) 8.National Council for Prescription Drug Programs (NCPDP)/National Association of Boards of Pharmacy (NABP) Provider ID (situational) 9.National Provider Identifier (NPI) (situational) 1.Name of drug 2.Strength 3.Form 4.Quantity dispensed 5.Days’ supply dispensed 6.Date prescription filled 7.Date written 8.Refills authorized 9.Refill number 10.Refill status to indicate a full or partial refill 11.Prescription number

19. Next Steps Review: Minimum Dataset Requirements & IG Template Next Solution Planning WG meeting is Thursday, June 26 from 12:00pm – 1:00pm ET Next All Hands meeting is Tuesday, July 1 from 12:00pm - 1:00pm ET Reminder: All PDMP & HIT Integration Announcements, Meeting Schedules, Agendas, Minutes, Reference Materials, Harmonization 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 http://wiki.siframework.org/PDMP+%26+Health+IT+Integration +Homepage

20. Contact Information – Initiative Coordinators: Johnathan Coleman jc@securityrs.comjc@securityrs.com Sherry Green sgreen@namsdl.orgsgreen@namsdl.org – ONC Leads: Mera Choi mera.choi@hhs.govmera.choi@hhs.gov Jennifer Frazier Jennifer.Frazier@hhs.govJennifer.Frazier@hhs.gov Helen Caton-Peters Helen.Caton- Peters@hhs.govHelen.Caton- Peters@hhs.gov – SAMHSA Leads Jinhee Lee Jinhee.Lee@samhsa.hhs.govJinhee.Lee@samhsa.hhs.gov Kate Tipping Kate.Tipping@samhsa.hhs.govKate.Tipping@samhsa.hhs.gov – Support Team: Project Management: Jamie Parker jamie.parker@esacinc.com jamie.parker@esacinc.com Ali Khan Ali.Khan@esacinc.com (Support)Ali.Khan@esacinc.com Use Case Development: Ahsin Azim Ahsin.Azim@accenturefederal.com Ahsin.Azim@accenturefederal.com Presha Patel presha.patel@accenture.com presha.patel@accenture.com Standards Development Support: Alex Lowitt alexander.s.lowitt@accenturefederal.com alexander.s.lowitt@accenturefederal.com Harmonization Support: Divya Raghavachari divya.raghavachari@accenturefederal.com divya.raghavachari@accenturefederal.com Atanu Sen atanu.sen@accenture.comatanu.sen@accenture.com Implementation Guide Development: Rita Torkzadeh rtorkzadeh@jbsinternational.com rtorkzadeh@jbsinternational.com Vijay Shah vshah@jbsinternational.comvshah@jbsinternational.com Vocabulary and Terminology Subject Matter Expert: Mark Roche mrochemd@gmail.commrochemd@gmail.com For questions, please feel free to contact your support leads:

21. Appendix

22. Questions to be answered: 1.Differences in pharmacy and clinician workflows / data systems and expectations in PDMP data transmitted? 2.How do we define intermediaries and their relationships to Health IT systems? 3.What components of PDMP report are extracted for decision support? 4.Can EHR and Pharmacy IT systems handle the proposed standards (in the context of PDMP systems)? 5.What standard(s) fit into message and workflow configuration per transaction type? 6.Are transactions collapsible in terms of capability of leveraging same standard? 7.Are all transactions necessary? 8.What is the cost associated with the proposed solutions? 9.How do we define an aggregator? (collection of response from different PDMPs back to recipient) 10.Parking lot item: Differences in care settings - Ambulatory vs. Acute; In-hospital pharmacies vs. retail pharmacies. Are different standards needed for different EHR systems?

23. Initiative Progress & Current Status Implementation Guide Development Solution Planning Narrowed down candidate standards via mapping to Use Case Requirements Identified and analysed gaps for all narrowed down standards in the Gap Mitigation Plan Develop Implementation Guide (IG) based on selected solution Standards Evaluation Determining standards currently in general use per transaction workflow Select harmonized standard solution based on current and recommended standards landscapes