PDMP & Health IT Integration

Standards and Harmonization

June 17th, 2014

Agenda

Topic Time Allotted

General Announcements 5 minutes

PDMP & HITI Standards and Harmonization•Summary of outcomes from Solution Planning Workgroup 6/12•Minimum dataset requirements analysis

50 minutes

Next Steps/Questions 5 minutes

PDMP Harmonization Timeline

March April May June July

3/25 Harmonization Kick-off

Stan

dard

s Ev

alua

tion

Candidate Standards List

UCR-Standards Mapping

Gap Mitigation Plan

HITSC Evaluation*

Solu

tion

Plan

ning

IG

Dev

elop

men

t

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 Monday @ 12 noon

1 3/25 Harmonization Kick-Off & Process OverviewIntroduce: Overview of UCR-Standards Mapping Review: N/A

2 4/1 Introduce: Candidate Standards List & UCR-Standards Mapping Review: Candidate Standards List

3 4/8 Finalize: Candidate Standards ListReview: UCR-Standards Mapping Review: UCR-Standards Mapping

4 4/15 Review: UCR-Standards Mapping Review: UCR-Standards Mapping

- 4/22 Cancelled for National Rx Summit

5 4/29 Finalize: Outcome of UCR-Standards MappingIntroduce: Gap Mitigation Plan Review: Gap Mitigation Plan

6 5/6 Review: Gap Mitigation Plan Review: Gap Mitigation Plan

7 5/13 Finalize: Gap Mitigation PlanIntroduce: Solution Planning Workgroup Review: N/A

8 5/20 Review: Outcomes of Solution Planning WorkgroupIntroduce: Implementation Guide (IG) Template Review: Implementation Guide Template

9 5/27 Review: Outcomes of Solution Planning WorkgroupIntroduce: Minimum Dataset Requirements

Review: Minimum Dataset Requirements & IG Template

10-11 6/3 – 6/10 Review: Outcomes of Solution Planning Workgroup & Minimum Dataset Requirements Review: Minimum Dataset Requirements

12 6/17 Review: Outcomes of Solution Planning Workgroup & Minimum Dataset Requirements Review: Minimum Dataset Requirements

13-15 6/24 – 7/8 Review: Proposed Solution Sets and Implementation Guide Content Review: Finalized Solution Plan & Implementation Guide

16-17 7/15 – 7/22 End-to-End Community Review of Implementation Guide End-to-End Review of Implementation Guide

18 7/29 Consensus Vote

Harmonization Weekly Timeline

Review: Solution Planning Workgroup

Session (6/12)

Solution Plan Workflow Analysis

Transactions Scope

From Via To

1a1b

EHRPharmacy

- In-State PDMP

2a 2b

EHRPharmacy

HIEPh. Int

In-State PDMP

3a3b

EHRPharmacy

Hub In-State PDMP

4 In-State PDMP - Out of State PDMP

5a5b

HIEPh. Intermediary

- Out-of-State PDMP

6 Hub - Out-of-State PDMP

7a7b

HIEPh. Intermediary

Hub In-State PDMP

8 In-State PDMP Hub Out-of-State PDMP

PMP/HITI User Stories with Alternate WorkflowsEHR 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 HubEHR 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

System1

2

3

42

36

57

7

Hub8 8

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

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and

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ITs

hand

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Stan

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Repo

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Summary of Transactions

Solution Plan Workgroup Transaction Analysis

Trans. System - Outbound

System Intermediary 1

System Intermediary 2

System Inbound

Status

1a EHR -- -- PDMP Complete

2a EHR HIE/Intermediary -- PDMP Complete

2a(i) EHR HIE/Intermediary PDMP Hub PDMPs Complete

3a EHR PDMP Hub PDMPs Complete

1b Pharmacy IT PDMP Complete

2b Pharmacy IT Intermediary/Switch PDMP Complete

2b(i) Pharmacy IT Intermediary/Switch PDMP Hub PDMPs Complete

3b Pharmacy IT PDMP Hub PDMPs Complete

Transaction Analysis Takeaways

Solution Plan Workgroup Transaction Analysis

Trans. Workflow Model Highlights

1a EHR to PDMP • Reduced complexity • Supports unique PDMP infrastructure• Necessary where policy hinders use of third parties

2a EHR 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

3a EHR 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

1b Pharmacy to PDMP • Pharmacies typically leverage third party for medication history• Limited interest from user community

2b Pharmacy 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

3b Pharmacy 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

Data Element Analysis

Minimum Required Data Set

Minimum Required Data Elements Analysis - Status

Solution Plan Workgroup Transaction Analysis

Data Category Transaction Mode Status Community Determination

Patient Information

Request Complete First NameLast NameDate of BirthPatient ID

Response To Be Completed

General Request To Be Completed

Response To Be Completed

Authorized User Request In Progress Authentication CredentialsType of User

Prescription Information

Response To Be Completed

Prescriber Response To Be Completed

Dispenser Response To Be Completed

Implementation Guide – Data Elements and Attributes

Data Requirements Analysis - PDMP & HITI Use Case

Request Transaction Data ElementsGeneral Authorized User Patient

1. Request Date2. Request Timestamp3. State of Request4. Requestor Location5. Requested State(s) [if

applicable]6. Authenticator7. System authentication8. Initiating requestor’s

routing ID9. Responder ID10.Message ID11.Requestor’s Internal

Patient ID12.Start Date13.End Date

1. First Name2. Last Name3. Generational Suffix [if

applicable]4. Address Information5. Optional Address

Information 6. City Address7. State Address8. ZIP Code Address9. Email Address10.Phone Number11.Authentication Credentials

[DEA, NCPDP/NABP Provider ID, NPI, License #, Delegate ID

12.Type of User

1. First Name2. Last Name3. Address Information4. Optional Address Information5. City Address6. State Address7. ZIP Code Address8. Phone Number9. Patient Gender10.Country11.Date of Birth12.Identification Qualifier of

Patient Identifier13.Identification of Patient

Data Requirements Analysis - PDMP & HITI Use Case

Response Transaction Data Elements

General Patient Prescription Prescriber Dispenser

1. Response Date2. Response

Timestamp3. Response Time4. State of Response5. Response Identifier6. Message ID7. Summary8. Create Time9. Intended Recipient10. Status of Request

1. First Name2. Last Name3. Address

Information4. Optional Address

Information5. City Address6. State Address7. Zip Code Address8. Country9. Date of Birth10. Identification

Qualifier of Patient Identification

11. Identification of Patient

12. PDMP Patient Reference Number

13. Gender Code14. Species Code15. Phone Number

1. Name of Drug2. Strength3. Form4. Quantity Dispensed5. Days Supply

Dispensed6. Date Written7. Refills Authorized8. Refill Number9. Partial Fill10. Prescription

Number11. Date Prescription

Filled12. Date Prescription

Sold/Dispensed13. Drug Identifier14. Payment Method

1. First Name2. Last Name3. Address Information4. Optional Address

Information5. City Address6. State Address7. Zip Code Address8. Phone Number9. DEA #10. Authentication

Credentials11. PDMP Prescriber

Reference #

1. Pharmacy or Dispensing Prescriber’s Name

2. Address Information

3. Optional Address Information

4. City Address5. State Address6. ZIP Code Address7. Phone Number8. DEA #9. NCPDP/NABP

Provider ID10. NPI11. PDMP Dispenser

Reference #

Consolidated Standard Data Set– PDMP & HITI Use Case

PDMP & HITI Use Case Data ElementsGeneral Patient Prescription Authorized User*

1. Request Date2. Request Timestamp3. State of Request4. Requestor Location5. Requested State(s) [if

applicable]6. Authenticator7. System authentication8. Initiating requestor’s

routing ID9. Responder ID10.Message ID11.Requestor’s Internal

Patient ID12.Start Date13.End Date14. Response Date15. Response Timestamp16. Response Time17. State of Response18. Response Identifier19. Summary20. Create Time21. Intended Recipient22. Status of Request

1. First Name2. Last Name3. Address Information4. Optional Address

Information5. City Address6. State Address7. Zip Code Address8. Country9. Date of Birth10. Identification Qualifier of

Patient Identification11. Identification of Patient12. PDMP Patient Reference

Number13. Gender Code14. Species Code15. Phone Number

1. Name of Drug2. Strength3. Form4. Quantity Dispensed5. Days Supply Dispensed6. Date Written7. Refills Authorized8. Refill Number9. Partial Fill10. Prescription Number11. Date Prescription Filled12. Date Prescription

Sold/Dispensed13. Drug Identifier14. Payment Method

1. First Name2. Last Name3. Address Information4. Optional Address

Information5. City Address6. State Address7. Zip Code Address8. Phone Number9. DEA #10. Authentication Credentials11. PDMP Prescriber Reference

#12. Pharmacy or Dispensing

Prescriber’s Name13. NCPDP/NABP Provider ID14. NPI15. PDMP Dispenser Reference

#16. Type of user

*Includes Physician and Dispenser

Standard Data Set– MITRE WG Recommendation

MITRE Standard Data ElementsPatient Prescriber Dispenser Prescription

1. First name2. Last name3. Street address4. City5. State6. ZIP code7. Date of birth8. Identification (ID)

qualifier and/or patient identifier (situational)

9. Gender code (situational)

10. Species code (situational)

11. Phone number (situational)

1. First name2. Last name3. Street address4. City5. State6. ZIP code 7. Phone number

(situational)8. Drug Enforcement

Agency (DEA) number (situational)

1. Pharmacy or dispensing prescriber name

2. Street address3. City4. State5. ZIP code6. 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 drug2. Strength3. Form4. Quantity dispensed5. Days’ supply dispensed6. Date prescription filled7. Date written8. Refills authorized9. Refill number10. Refill status to indicate

a full or partial refill11. 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– http://wiki.siframework.org/PDMP+%

26+Health+IT+Integration+Homepage

Contact Information

– 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

• Standards Development Support:• Alex Lowitt

alexander.s.lowitt@accenturefederal.com

• Harmonization Support:• Divya Raghavachari

divya.raghavachari@accenturefederal.com

• Atanu Sen atanu.sen@accenture.com• Implementation Guide Development:

• Rita Torkzadeh rtorkzadeh@jbsinternational.com

• Vijay Shah vshah@jbsinternational.com• Vocabulary and Terminology Subject Matter

Expert: • Mark Roche mrochemd@gmail.com

• For questions, please feel free to contact your support leads:

Appendix

Summary of Transaction-level Analysis 6/5

Transaction Summary from SPWG 6/5 Status

Pros Cons

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

Transaction Summary from SPWG 6/12 Status

Pros Cons2a: 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

Transaction Summary from SPWG 6/5 Status

Pros Cons1b: 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

Transaction Summary from SPWG 6/5 Status

Pros Cons

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 SystemIn-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 OBXXML Report

NCPDP SCRIPT (Med History)HL7 DOC^T12 - CCD

HL7 ADT feedsNCPDP SCRIPT (Med History)HL7 QRY^T12

HL7 A04NCPDP SCRIPT with PMIX

WrappersThird Party Software

HL7 QRY^T12

XML ResponseNCPDP SCRIPT with

PMIX WrapperHL7 DOC^T12

Transaction 2a

Current In-State Pharmacy Workflow (Direct)

Pharmacy IT System

In-State PDMP

Request

Response

Legend

Transaction 1b

NARxCheck

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 SystemIn-State PDMP

Request

Response

Legend

PMIX

Transaction 3a – Not Effective Workflow? Currently Active?

PDMP HubInterface

PMIX

PMIXPMIX

HL7

Current In-State Pharmacy Workflow (Hub)

In-State PDMP

Request

Response

Legend

?

Translation? PMIX

PMIX

Transaction 3b – Not Effective Workflow? Currently Active?

PDMP HubPharmacy

System

Translation?

Current Interstate EHR Workflow

EHR System HIEIn-State PDMP

Request

Response

Legend

NCPDP SCRIPT (Medication

History)

Third Party SoftwarePMIX-NIEM

Out-of-State PDMP

PMIX-NIEM

PDMP Hub

PMIX-NIEM

XML

PMIX-NIEM

PMIX-NIEMXML

Transaction 2a + 7a + 6

Current Interstate Pharmacy Workflow

HIEIn-State PDMP

Request

Response

Legend

NCPDP SCRIPT

Third Party SoftwarePMIX Wrappers

PMIX-NIEM

PDMP Hub

PMIX-NIEM

XML

PMIX-NIEM

PMIX-NIEMXML

Pharmacy System

Pharmacy Int. /

SwitchOut-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 GuideDevelopment

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