PDMP & Health IT Integration Standards and Harmonization June 17 th, 2014

Agenda TopicTime Allotted General Announcements5 minutes PDMP & HITI Standards and Harmonization Summary of outcomes from Solution Planning Workgroup 6/12 Minimum dataset requirements analysis 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 126/17 Review: Outcomes of Solution Planning Workgroup & Minimum Dataset Requirements Review: Minimum Dataset Requirements /24 – 7/8Review: Proposed Solution Sets and Implementation Guide Content Review: Finalized Solution Plan & 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 (6/12) Solution Plan Workflow Analysis

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 Hub 88

Solution Planning Work Group Approach 1. Overlay standards currently in general use per transaction - focus on transactions for integrated solutions 3. For each alternate 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

Summary of Transactions Solution Plan Workgroup Transaction Analysis Trans.System - Outbound System Intermediary 1 System Intermediary 2 System Inbound Status 1aEHR-- PDMPComplete 2aEHRHIE/Intermediary--PDMPComplete 2a(i)EHRHIE/IntermediaryPDMP HubPDMPsComplete 3aEHRPDMP HubPDMPsComplete 1bPharmacy ITPDMPComplete 2bPharmacy ITIntermediary/SwitchPDMPComplete 2b(i)Pharmacy ITIntermediary/SwitchPDMP HubPDMPsComplete 3bPharmacy ITPDMP HubPDMPsComplete

Transaction Analysis Takeaways Solution Plan Workgroup Transaction Analysis Trans.Workflow ModelHighlights 1aEHR to PDMP Reduced complexity Supports unique PDMP infrastructure Necessary where policy hinders use of third parties 2aEHR to Intermediary to PDMP (Hub to PDMPs) Scalable Provides flexibility in accommodating standards Provides ability to leverage existing connections for clinical data Increased complexity due to additional connections 3aEHR to Hub to PDMPs Capable of facilitating interstate data exchange with reduced complexity Capable of handling state-specific policy/regulation Future hub capabilities support efficient workflow model 1bPharmacy to PDMP Pharmacies typically leverage third party for medication history Limited interest from user community 2bPharmacy to Intermediary to PDMP (Hub to PDMPs) Existing connections allow access to other clinical information Concern regarding cost to participate May allow for future-state PDMP-data access through third parties 3bPharmacy to Hub to PDMPs PDMP Hubs are compliant with state regulations regarding access and routing of PDMP-data Model reduced complexity regarding interstate data exchange

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

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

Data Element Analysis

Minimum Required Data Elements Analysis - Status Solution Plan Workgroup Transaction Analysis Data CategoryTransaction ModeStatusCommunity Determination Patient Information RequestCompleteFirst Name Last Name Date of Birth Patient ID ResponseTo Be Completed GeneralRequestTo Be Completed ResponseTo Be Completed Authorized UserRequestIn ProgressAuthentication Credentials Type of User Prescription Information ResponseTo Be Completed PrescriberResponseTo Be Completed DispenserResponseTo Be Completed

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 19 from 12:00pm – 1:00pm ET Next All Hands meeting is Tuesday, June 24 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

Summary of Transaction-level Analysis 6/5 TransactionSummary from SPWG 6/5Status ProsCons 1a: EHR to PDMP (Direct) Simplicity of reduced actors Support uniqueness of PDMP infrastructure Support situations where legal limitations prevent use of a hub/intermediary Possible high front cost of developing interfaces and connections to the initiating system - in instances when translations are necessary Redevelopment of new sources, new connections Cost for certified EHR systems to adopt new standards may be high Maintenance costs associated with multiple point to point connections could be high Cost could depend on the standards chosen and/or implementations using interfaces Relative cost is measured in terms of connectivity Complete Revisit: 1.Relative costs and impact to stakeholders based on standards 2.Consideration of translations necessary to support workflow

Transaction-level Analysis from SPWG 6/12 TransactionSummary from SPWG 6/12Status ProsCons 2a: EHR to PDMP via Intermediary Provides EHR system ability to leverage existing standards built into certified systems Transformations without extending work to EHR systems Potential for scalability; reach multiple initiating systems from various locations Intermediary can act as a pass through to accommodate policy/regulations Challenges associated with connections through HIEs to end- users Potential for additional complexity due to multiple actors across workflow Potential limitations of translations due to state policy/regulations Complete 3a: EHR to PDMP via Hub Established connections to various PDMPs to facilitate interstate data exchange Readily capable to address state variability in policy/regulations Existing precedence to support integration projects (previous pilots) Infrastructure provides capability for transformation/translation service or API Understanding of data elements required for effective querying for persons of interest Existing work is being done to translate PMIX to existing EHR standards (NABP - PMPi Gateway)(HID states) May force some of the cost to be placed on the state PDMPs Hubs may cover some of the costs to use the hubs; some cost to the EHRs Concern about overall transaction fees PMIX-NIEM standards are not currently included in the EHR system certification standard set - may require translation Complete

Transaction-level Analysis from SPWG 6/12 TransactionSummary from SPWG 6/5Status ProsCons 1b: Pharmacy to PDMP (Direct) Simplicity of reduced actors Support uniqueness of PDMP infrastructure Support situations where legal limitations prevent use of a hub/intermediary Pharmacies typically utilize a third party system to access PDMPs Pharmacies typically leverage a web service outside of their clinical workflow Not as much interest from the user community for this workflow model Complete 2b: Pharmacy to PDMP via Intermediary Connecting to intermediaries could allow access/flexibility to other clinical information outside of just PDMP-data (i.e. immunization data) -Includes various trading partners via one connection Existing established connections provide a variety of valued-added services that could be attractive as a potential solution when accessing PDMP data Intermediary could connect directly to the in-state PDMP or a hub Intermediaries will cost pharmacies to use Concern across community for pharmacies using intermediaries Adds complexity due to increased number of actors involved in communication of query/query- response transmission -could be less attractive to community/retail pharmacies state legal concerns regarding intermediary access to PDMP-data Complete

Transaction-level Analysis from SPWG 6/12 TransactionSummary from SPWG 6/5Status ProsCons 3b: Pharmacy to PDMP via Hub Established connections to leverage out-of- state PDMP data PDMP Hubs are compliant with state regulations regarding access and routing of PDMP-data Reduced complexity due to reduced number of actors when compared to Ph. To Intermediary to Hub to PDMP Value added services that a pharmacy switch could provide are not inherent to PDMP Hub capabilities Complete

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 ? ? ? ? Transaction 2b SCRIPT used for medication history but does not currently pull Controlled Substance history from Intermediaries using SCRIPT standard.

Current In-State EHR Workflow (Hub) EHR System In-State PDMP Request Response Legend PMIX Transaction 3a – Not Effective Workflow? Currently Active? PDMP Hub Interface PMIX HL7

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