PDMP & Health IT Integration Standards and Harmonization June 3 rd, 2014

Agenda TopicTime Allotted General Announcements5 minutes PDMP & HITI Standards and Harmonization Summary of outcomes from Solution Planning Workgroup 5/29 Continue to determine minimum dataset requirements 50 minutes Next Steps/Questions5 minutes

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

Week Target Date (2014) All Hands WG Meeting Tasks Review & Comments from Community via Wiki page due following 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 /3 – 6/10 Review: Outcomes of Solution Planning Workgroup & Minimum Dataset Requirements Review: Minimum Dataset Requirements & IG Content 126/17Finalize: Proposed SolutionReview: Proposed Solution & IG Content /24 – 7/8Review: Implementation Guide ContentReview: Implementation Guide /15 – 7/22End-to-End Community Review of Implementation GuideEnd-to-End Review of Implementation Guide 187/29Consensus Vote Harmonization Weekly Timeline

Review: Solution Planning Workgroup Session 5/29 Current-State Transaction: Standards Landscape

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 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/ Pharmacy Intermediary In-State PDMP Out of State PDMP Hub EHR or Pharmacy System Hub 88

Summary of Transactions Data Flow Transactions Reviewed on 5/15 & 5/22 & 5/29 SPWG TransactionSystem - OutboundSystem Intermediary 1System Intermediary 2System Inbound 1aEHR-- PDMP 1bPharmacy IT-- PDMP 2aEHRHIE--PDMP 2bPharmacy ITPharm. Int. / Switch--PDMP 3aEHR--PDMP HubPDMPs 2a+7a+6EHRHIEPDMP HubPDMPs 3bPharmacy ITPDMP HubPDMPs 2a + 2b + 7a + 7b + 6 Pharmacy ITPharm. Int. / Switch or HIE PDMP HubPDMPs

TransactionSummary from SPWG 5/15Items Required for Further Clarification 1a: EHR System to PDMP (Direct) EHRs don’t generally query PDMPs directly Ohio connectivity model is a direct connection to OARRS via PMIX Kansas leverages HIEs and PMPi data hub for all of their connections Illinois and Ohio use a direct connection – need further clarification on standards used Jinhee Lee to gather information on transactions occurring in Illinois, Kansas, Indiana – Complete Jean Hall to confirm Ohio connectivity model – Complete 2a: EHR System to PDMP via HIE HL7 messaging relatively uncommon in EHRs for PDMP connections Kentucky using QRY^T12 as request and DOC^T12 as acknowledgment and response message – CCD structure Some states that cannot make interstate connections might have no other option but to use this model Washington, Maryland, Maine, Oklahoma use this model Washington response – PMIX-NIEM is mapped to NCPDP SCRIPT and responding with NCPDP SCRIPT message ADT used as trigger in Ohio, Indiana, Illinois, Kansas Jean Hall to further clarify what the query/message pairing used to engage EHR system to HIE – Complete 1b: Pharmacy IT System to PDMP (Direct) Transaction 1b is not currently in use ASAP Web Services standard was developed specifically with this transaction in mind NCPDP Medication History might be suitable for this purpose but is not used currently Jean Hall to further clarify standards currently in use – Complete

TransactionSummary from SPWG 5/15Items Required for Further Clarification 2b: Pharmacy IT System to PDMP via Pharmacy Intermediary/ Switch NCPDP SCRIPT Medication History is being used today but not for the purposes of querying PDMP data Real-time query for claim to be dispensed through switch via Telecommunication standard Not yet in use but is possible via claim submission SureScripts to enable this transaction (Intermediary to PDMP) in the future Lynne Gilbertson to verify if standards are currently being used (Nebraska) – Complete TransactionSummary from SPWG 5/22Items Required for Further Clarification 3a: EHR System to PDMP via Hub Ohio, Kansas use PMIX to connect to PMPi data hub PMP Gateway will be used in the future to centralize translations, where endpoints can communicate with gateway EHR provides translation from HL7 (V2/ADT?) to PMIX in Kansas pilots Hub functions as aggregator, depending on arrangements Clay Rogers and Jeff McGonigal to verify translation/EHR generating PMIX request– Complete

TransactionSummary from SPWG 5/22Items Required for Further Clarification 2a + 7a + 6: EHR System to HIE to Hub to PDMP Indiana and North Dakota provides translation to PMIX from the HIE to the Hub HIE translates using NCPDP SCRIPT with PMIX wrapper for Hub SureScripts and Emdeon used by EHR Systems to obtain medication history data – not yet used for controlled substance history Emdeon does not support HL7 SureScripts predominantly supports SCRIPT Ohio EHR Systems leverages NARxCheck as an interface to in-state PDMP Does not go through HIE or Hub (PMPi) HL7 ADT used as a trigger to send query NARxCheck handles transformation of HL7 to PMIX architecture Message received by PMP: PMIX-NIEM NARxCheck does not act as a hub but may get information from PMPi Does not go through interconnect directly Jinhee Lee to verify how Indiana performs translation from HIE to Hub – Complete Danna Droz and Chad Garner to confirm third party software functionality of NARxCheck via NABP – Complete

TransactionSummary from SPWG 5/29Items Required for Further Clarification 3b: Pharmacy IT System to PDMP via Hub Hub to PDMP available for use but is not currently in production Pharmacy IT System to hub not currently in use Technology may be used in the future Ohio to possibly pilot for a pharmacy chain to go through hub (one of 16 states that is a part of SAHMSA grant) Support Team to determine what standards these transactions are based on – In progress 2a + 2b + 7a + 7b + 6: Pharmacy IT System Interstate Workflow Not currently in use but Pharmacy IT System May be able to go through intermediary in the future Pharmacy workflow using controlled substance medication history through a Pharmacy Intermediary could be a future use case PDMP checking on a claim vs. query of history for controlled substances N/A

Solution Planning Work Group Approach 1. Overlay standards currently in general use per transaction - focus on transactions for integrated solutions 2. For each alternate workflow, propose solutions for harmonizing standards in order to pull PDMP information into EHR or Pharm. IT Systems synchronously 3. 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

Next Steps for SPWG 6/10, 6/17 1.Identify effective workflows 2.Prioritize workflows according to current landscape analysis, standards evaluation, and future state models 3.Collapse workflows to represent proposed solutions incorporated in the Implementation Guide – Analyze pros/cons, technical feasibility, impact to stakeholders, adoptability, scalability, etc.

Summary Analysis + Relevant Workflows Current Landscape Workflows Proposed Solution Set Workflows EHR  In-State PDMP Pharmacy  In-State PDMP EHR  Intermediary  In-State PDMP Pharmacy  Intermediary  In-State PDMP EHR  Hub  PDMP  (s) Pharmacy  Hub  PDMP(s) EHR  Intermediary  Hub  PDMP(s) Pharmacy  Intermediary  Hub  PDMP(s) EHR  In-State PDMP  Hub  PDMP(s) Pharmacy  In-State PDMP  Hub  PDMP(s) EHR  In-State PDMP Pharmacy  In-State PDMP EHR  Intermediary* Pharmacy  Intermediary EHR  Hub Pharmacy  Hub 1.Aligns to in-scope Use Case scenarios 2.Approach may require translation mapping between ASAP, NCPDP SCRIPT Medication History, and H L7 V2 Messaging to PMIX Architecture 3.Implementation Guide will have to include data element modifications/additions to fully support PDMP & HITI Use Case requirements *Intermediary - An entity that routes the transaction to a receiving entity. May perform value added services such as translating data from one format to another

Summary Analysis Strategy Details  Implementation Guide focus will shift to those organizations providing transformations/translation/ ETL services  ASAP can provide point-to-point PDMP data exchange for Pharmacies and EHRs a like – can be transformed into PMIX Architecture via Appriss, Inc. (PMPi)  Intermediaries provide translation service or metadata transformations as “wrappers”  Data elements will need to be modified or added, specified within the PDMP & HITI Implementation Guide Example Container/Payload Configuration ASAP Web Services HL7 V2 Messaging NCPDP SCRIPT Medication History PMIX-NIEM Architecture PDMP Hub Intermediary Health IT System Standard PDMP Standard Translation (Patient Data)

Data Element Analysis

Implementation Guide – Data Elements and Attributes

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. 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

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 #

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

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

Next Steps Review: Minimum Dataset Requirements Next Solution Planning WG meeting is Thursday, June 5 from 12:00pm – 1:00pm ET Next All Hands meeting is Tuesday, June 10 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 – +Homepage +Homepage

Contact Information – Initiative Coordinators: Johnathan Coleman Sherry Green – ONC Leads: Mera Choi Jennifer Frazier Helen Caton-Peters Helen.Caton- – SAMHSA Leads Jinhee Lee Kate Tipping – Support Team: Project Management: Jamie Parker Ali Khan Use Case Development: Ahsin Azim Presha Patel Standards Development Support: Alex Lowitt Harmonization Support: Divya Raghavachari Atanu Sen Implementation Guide Development: Rita Torkzadeh Vijay Shah Vocabulary and Terminology Subject Matter Expert: Mark Roche For questions, please feel free to contact your support leads:

Appendix

Current In-State EHR Workflow (Direct) EHR System In-State PDMP NARxCheck Request Response Legend Transaction 1a NARxCheck

Current In-State EHR Workflow (HIE) EHR System HIE In-State PDMP Request Response Legend HL7 OBX XML Report NCPDP SCRIPT (Med History) HL7 DOC^T12 - CCD HL7 ADT feeds NCPDP SCRIPT (Med History) HL7 QRY^T12 HL7 A04 NCPDP SCRIPT with PMIX Wrappers Third Party Software HL7 QRY^T12 XML Response NCPDP SCRIPT with PMIX Wrapper HL7 DOC^T12 Transaction 2a

Current In-State Pharmacy Workflow (Direct) Pharmacy IT System In-State PDMP Request Response Legend Transaction 1b NARxCheck

Current In-State Pharmacy Workflow (Pharmacy Int. / Switch) Pharmacy System Pharmacy Intermediary / Switch In-State PDMP Request Response Legend NCPDP SCRIPT (Medication History) ? ? Transaction 2b

Current In-State EHR Workflow (Hub) EHR System In-State PDMP Request Response Legend ? PMIX ? ? Transaction 3a – Not Effective Workflow? Currently Active? PDMP Hub

Current In-State Pharmacy Workflow (Hub) In-State PDMP Request Response Legend ? Translation? PMIX Transaction 3b – Not Effective Workflow? Currently Active? PDMP Hub Pharmacy System Translation?

Current Interstate EHR Workflow EHR System HIE In-State PDMP Request Response Legend NCPDP SCRIPT (Medication History) Third Party Software PMIX-NIEM Out-of- State PDMP PMIX-NIEM PDMP Hub PMIX-NIEM XML PMIX-NIEM XML Transaction 2a + 7a + 6

Current Interstate Pharmacy Workflow HIE In-State PDMP Request Response Legend NCPDP SCRIPT Third Party Software PMIX Wrappers PMIX-NIEM PDMP Hub PMIX-NIEM XML PMIX-NIEM XML Pharmacy System Pharmacy Int. / Switch Out-of- State PDMP NCPDP SCRIPT ? ? Transaction 2a + 2b + 7a + 7b + 6

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?

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