1. PDMP & Health IT Integration All-Hands Meeting December 3rd, 2013

2. Meeting Etiquette 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. NOTE: This meeting is being recorded and will be posted on the Meeting Artifacts Wiki page after the meeting From S&I Framework to Participants: Hi everyone: remember to keep your phone on mute 2

3. Agenda TopicTime Allotted General Announcements5 minutes Complete review of Project Charter15 minutes Review comment dispositions30 minutes Next Steps/Questions10 Minutes 3

4. General Announcements The PDMP & Health IT Integration All-Hands meets every Tuesday from 12:00-1:00 PM EDT – To participate please see the “Weekly Meetings” Section of the PDMP & Health IT Integration Wiki Homepage: http://http://wiki.siframework.org/PDMP+%26+Health+IT+Integrat ion+Homepage http://http://wiki.siframework.org/PDMP+%26+Health+IT+Integrat ion+Homepage Note: Please check the meeting schedule weekly to get the most up-to-date meeting information 4

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+t he+Initiative http://wiki.siframework. org/PDMP+%26+Health +IT+Integration+Join+t he+Initiative 5

6. Initiative Support Leads For questions, please feel free to contact your support leads: – Initiative Coordinator: Johnathan Coleman jc@securityrs.comjc@securityrs.com – ONC Leads: Mera Choi mera.choi@hhs.govmera.choi@hhs.gov Jennifer Frazier Jennifer.Frazier@hhs.govJennifer.Frazier@hhs.gov Scott Weinstein Scott.Weinstein@hhs.govScott.Weinstein@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.comjamie.parker@esacinc.com – Ali Khan Ali.Khan@esacinc.com (Support)Ali.Khan@esacinc.com Use Case Development: – Presha Patel presha.patel@accenture.compresha.patel@accenture.com – Ahsin Azim Ahsin.Azim@accenture.com (Support)Ahsin.Azim@accenture.com Vocabulary and Terminology Subject Matter Expert: – Mark Roche mrochemd@gmail.commrochemd@gmail.com 6

7. PhasePlanned Activities Pre-Discovery  Development of Initiative Background  Development of Initiative Charter  Definition of Goals & Initiative Outcomes Discovery  Creation/Validation of Use Cases, User Stories & Functional Requirements  Identification of interoperability gaps, barriers, obstacles and costs  Review of Vocabulary Implementation  Creation of aligned specification  Documentation of relevant specifications and reference implementations such as guides, design documents, etc.  Validation of Vocabulary  Development of testing tools and reference implementation tools Pilot  Validation of aligned specifications, testing tools, and reference implementation tools  Revision of documentation and tools Evaluation  Measurement of initiative success against goals and outcomes  Identification of best practices and lessons learned from pilots for wider scale deployment  Identification of hard and soft policy tools that could be considered for wider scale deployments S&I Framework Phases & PDMP & Health IT Integration Activities 7 We are Here

8. PDMP & Health IT Project Charter Background… Prescription drug misuse and overdose is one of the fastest growing health epidemics in the United States. One of the most promising clinical tools to address prescription drug abuse are prescription drug monitoring programs (PDMPs). PDMPs are state-run electronic databases – functioning in 48 U.S. states and territories – that track the prescribing and dispensing of controlled prescription drugs to patients. Information within PDMPs is intended to enhance providers’ understanding of their patients’ controlled substance history. When available at the point of care and point of dispensing, PDMP information can help prescribers and dispensers discern between patients who may need a controlled substance for legitimate medical treatment and those who may be seeking to misuse prescription drugs. It also provides an opportunity to intervene if there are signs of misuse and abuse. 8

9. PDMP & Health IT Project Charter Background continued While PDMPs collect a considerable amount of important clinical data which prescribers and pharmacists see as a valuable clinical decision support tool, they often do not use PDMPs because they are “stand alone” systems which are cumbersome and time consuming to access. Currently, most prescribers and dispensers must either interrupt their workflow and log on to a separate system to access the PDMP or write/dispense prescriptions without consulting the PDMP - potentially leaving providers without the information needed to make important clinical decisions. One way to improve PDMP access is it to incorporate it as part of the normal clinical workflow. Health IT systems (e.g., EHRs, HIEs, and pharmacy systems) can accomplish this by querying PDMPs for prescription information and presenting this information to prescribers and dispensers when they access an electronic medical record or pharmacy. 9

10. PDMP & Health IT Project Charter Challenge While there are data exchange standards in place to share information between PDMPs and standards to exchange information between EHRs and a Pharmacy there are no widely adopted standards for the exchange of data between an EHR and a PDMP. As PDMP systems have evolved outside the health IT ecosystem, significant barriers to interoperability have resulted. Current technical barriers to interoperability: – Lack of standard methods to exchange and integrate the prescription drug data available in PDMPs into health IT systems. – Lack of common technical standards and vocabularies to enable PDMPs to share computable information with the EHR that providers can use to support clinical decision-making. – Currently there is no standard set of data elements collected by states. To achieve interoperability, consistent and standardized electronic methods need to be established to enable seamless and secure data transmission between PDMPs and health IT systems. 10

11. PDMP & Health IT Integration – Project Charter Purpose & Goals The purpose of this initiative is to bring together the PDMP and health IT communities to standardize the data format, and transport and security protocols to exchange patient controlled substance history information between PDMPs and health IT systems (i.e., EHRs/HIEs/Pharmacy Systems). Doing so would enable health care providers to make more informed clinical decisions through timely and convenient access to PDMP data in an effort to reduce prescription drug misuse and overdose in the United States. The specific goals are: – Identify existing stakeholders and methodologies for accessing PDMP data (how they access this will help with pilots) – Identify, evaluate, and harmonize the data format(s) sent from PDMPs to EHRs/HIEs. – Evaluate and select transport protocol(s) systems support. – Evaluate and select security protocol(s) systems support. – Map selected health IT standards to standards already in use for PDMP-to-PDMP interstate exchange. 11

12. PDMP & Health IT Integration – Project Charter Scope Statement To allow system integrations that arms providers with PDMP data as part of their normal clinical workflow by: – Connecting PDMPs to health IT systems (e.g. EHRs and HIEs, and pharmacy Systems) using existing standards; – If standards do not exist, establishing standards for facilitating information exchange between PDMPs and health care providers; and – Improving timely and convenient access to PDMP data by health care providers. Out of Scope – Defining method for how the PDMP is contacted or initiated by provider (e.g., hyperlink while ordering, pressing a button, automatic trigger, etc.); and Addressing delegation of rights to individuals not legally authorized to prescribe medications – this is an implementation specific decision – this may vary by implementation and pilot sites. – PDMP to PDMP transactions – Third party access this is an implementation specific decision – this may vary by implementation and pilot sites 12

13. PDMP & Health IT Integration – Project Charter Value Statement The feedback received from health IT community on interoperability between PDMP and EHRs will influence data format, application programmatic interface, and transport protocol for interfaces for extracting data from PDMP instances; The outcome will be a specification describing the data interface for extracting prescription information from a PDMP instance for use by health IT systems; and The ability for prescribers and dispensers to access prescription drug data for patients at the point of care to make informed decisions to reduce prescription drug misuse and overdose 13

14. PDMP & Health IT Integration – Project Charter Potential Standards for Consideration The below standards are a starting list for consideration and will be updated based on community feedback during Charter discussions and as use case requirements are further fleshed out and we begin the harmonization process. This is not a full list of all possible standards. – Content and Structure: C32, CDA R2, FHIR, HL7 V.2.X, XML – Transport and Security: NCPDP SCRIPT, hData, SOAP, ASAP Webservices, XDR and XDM (Direct) * – Other: NIEM IEPD, PMIX – Other references: NarxCheck, OpenSearch, Rcopia, RHEx, RPC, Surescript, Zero Report Standard (by ASAP) – Vocabulary Standards: RxNorm 14 * Security and Transport standards will be dependent on the architecture/environment considerations

15. PDMP & Health IT Integration – Project Charter Potential Risks Risk: If data is intercepted en route between a PDMP and a prescriber, patient confidentiality may be compromised. – Mitigation: Employ secure protocols to encrypt and protect data in transit and prevent unauthorized disclosure. Unintended access to data not requested by the prescribers Patient mismatch Financial challenges of a new standards requirement accepted time for data download – currency of the data has impact on use of data 15 This is not a comprehensive list of risks – it is meant to identify the most immediate risks and to acknowledge those things which require further consideration and thought as we work through the PDMP and HIT initiative

16. PDMP & Health IT Integration – Project Charter Stakeholders Prescription Drug Monitoring Programs Prescription drug prescribers and dispensers Patients and patient advocates EHR/EMR vendors State HIEs Local, State, Federal Government Health Organizations Standards Organizations Healthcare Payers 16

17. PDMP & Health IT Integration – Project Charter Proposed Timeline Kick-off (11/14) Pre-Discovery, Call for Participation Jan 14 June 14 Discovery Initiative End 17 Nov 13 July 14 Mar 14 Implementation Pilot User Stories, Use Cases, Functional Requirements Standards Gap Analysis Harmonized Specifications Technology Evaluations Reference Model Implementation & Validation Use Case Kick Off Use Case Consensus Standards and Harmonization Kick Off Pilot Kick Off

18. Comments from wiki: NameOrganizationMember Status Project Charter Section Comment or Proposed ModificationDispositionDisposition Discussion Kari Shanard- Koenders SD PDMP/Board of Pharmacy Committed Member General Comment Excellent idea for a very important initiative. Thank you Holly Walpole INSPECTOther Interested Party General Comment One of the comments made on today's call regarded sharing data with other State agencies, I think that it is important that we have the means to collaborate with other agencies in terms of data collaboration: State Department of Health, Medicaid, Medicaid Fraug Units, and the like. I think we need to share data dictionaries/definitions and general information with them at some point Accepted with Modification Agencies are potential users of the PDMP guide we produce and could be considered potential stakeholders. It would be helpful to ensure we have the listed stakeholders on our planning calls to ensure the standard transactions proposed are implementable by those stakeholders. What we are trying to do in this initiative is to define standard transactions that can be consumed however is up to the states to determine how that transaction happens.

19. Comments from wiki… Carl Flansbaum NM PMPCommitted Member General Comment There should be a consistent term for the use of EHR/HIE/Pharmacy Systems (possibly defined in the Background) and this should then be what is used throughout the charter. For instance only EHRs is referred to in the Challenge Statement. The term "Health IT Systems" may work, although I don't know if a PDMP could also be considered this as well. persuasive with modcall out what health IT system is on first use of this - we will have a glossary Deb BassNeHIIOther Interested Party General Comment NeHII, the statewide HIE also serves as the PDMP for the state of NE. I find it amazing that there seems to be two separate universes - that of the PDMP and the HIE and we are both struggling with the same challenges: sustainability, physician adoption, interoperability, exchange of data across state lines, lack of standards, data integrity, privacy, security, etc. I am thrilled to see this question being addressed. persuasive

20. Comments from wiki… Darren K. Townzen WalmartCommitted Member Background"PDMP information can help providers care and point of dispensing" - Was this maybe left in error? It does not seem to fit in the syntax of the paragraph. persuasive Darren K. Townzen WalmartCommitted Member Purpose and Goals Doing so would enable health care providers to make more informed clinical decisions though timely and convenient (ADD effective) access to PDMP data in an effort to reduce prescription drug misuse and overdose in the United States. The specific goals are:.... persuasive Darren Townzen WalmartCommitted Member Potential Standards for Consideration ADD - NCPDP Telecommunications Persuasiveadded as candidate standard

21. Comments from wiki… David Hopkins Kentcky Cabinet for Health and Family Services Other Interested Party General Comme nt On the call last week there was much discussion of the terms to use for provider stakeholders. My suggestion is to modify the 2nd paragraph of the background section as follows; then use "providers" or "practioners and dispensers" throughout the charter document. Information within PDMPs is intended to enhance providers’ understanding of their patients’ controlled substance history. When available at the point of care and point of dispensing, PDMP information can help providers (practitioners and pharmacists) discern between patients who may need a controlled substance for legitimate medical treatment and those who may be seeking to misuse prescription drugs. It also provides an opportunity to intervene if there are signs of misuse and abuse So the third paragraph would read: While PDMPs collect a considerable amount of important clinical data which practitioners and pharmacists see as a valuable decision support tool, they often do not use PDMPs because they are “stand alone” systems which are cumbersome and time consuming to access. I also suggest changing the first sentence of the 4th paragraph as follows. Currently, most practitioners and pharmacists must either interrupt their workflow and log on to a separate system to access the PDMP, or write and dispense prescriptions without consulting the PDMP- potentially leaving providers without the information needed to make important clinical decisions. Persuasivedefine in glossary and define on first use -review MITRE definition

22. Comments from wiki… Shelly Spiro Pharmacy HIT Collaborative Committed Member StakeholdersRecommend adding pharmacists, care coordinators, behavioral health team members Accepted with modification - the description has been made more broad but within legal authorization Shelly Spiro Pharmacy HIT Collaborative Committed Member Scope Statement If out of scope statement "Third party access this is an implementation specific decision – this may vary by implementation and pilot sites" includes non- prescribing or dispensing providers, then we disagree. Other providers of care (e.g. pharmacists, care coordinators, behavioral health team members) who may not be a prescriber or dispenser need EHR access to PDMP information to clinically manage the patients medications. There should not be a different standard process for the non-prescriber/dispenser EHR access. Not persuasive we can only define standard transactions that enable authorized access. We cannot determine who should be given access to the PDMP, PDMP access is determined by state law and state statute John Odden C4UHCommitted Member BackgroundSuggest adding at end, "Additionally, EHR success may benefit from understanding and addressing cases where PDMP data integrated into an EHR is not readily accessible in Urgent Care and Emergency Department scenarios." Need Clarification

23. Comments from wiki… John Odden C4UHCommitted Member Challenge Statement Suggest changing "health IT ecosystem/system" to "medical provider health IT ecosystem/system," since pharmacies and pharmacy boards often consider themselves to be within the ecosystem. Persuasive John Odden C4UHCommitted Member Challenge Statement Suggest changing "lack of common technical standards" to read "lack of agreed" or "lack of acknowledged technical standards." Standards used by PDMPs are reasonably described as common or familiar and can map simply into many Certified EHR solutions. If WE agree that this is so, are we creating some new standards, or simply acknowledging/agreeing what already can work very well in field deployments? Accepted with modification "Widely adopted" John Odden C4UHCommitted Member Purpose and Goals What IS our purpose here? Is there a requirement / need to establish "exchange" between PDMP and Health IT systems? If the basic mission is to "transmit" from PDMP to Health IT, can we simplify this work stream by just saying that? Suggestion: Replace "exchange patient... information between PDMPs and Health IT systems (i.e. EHRs/HIEs)" with "transmit or communicate patient information from PDMPs to Health IT systems (i.e. EHRs)." Also note that some state laws and PDMP agreements are not supportive of placing PDMP Reports into HIEs. Don't we benefit from increasing applicability of our work by focusing the Purpose just a bit more? Accepted with modification Define use case requirements and implementation guide to securely and appropriately communicate patient controlled substance data from PDMP to HealthIT system

24. Comments from wiki… John Odden C4UHCommitted Member Scope Statement Constrain the Scope to the first sentence "to allow systems integrations that arm providers with PDMP data as part of their normal clinical workflow." To do this, simply change "(e.g. EHRs and HIEs)" to "(e.g. EHRs)." And change from "facilitating information exchange between PDMPs and health care providers" to read "facilitating information integration from PDMPs to health care providers." IF we intend to backward integrate FROM health care providers TO PDMPs (e.g. "exchange" instead of transmit/integrate) then the entire document should be rewritten to include reviewing/modifying how pharmacies and pharmacy boards work together to generate PDMP Reports in the first place. Accepted with modification John Odden C4UHCommitted Member Scope Statement In "Out of Scope" consider deleting the first bullet. If we're going to "solve" the standards issues around transmitting / integrating PDMP data into the EHR, then don't we really need to speak to HOW the provider workflow may invoke this per-patient integration? If we don't delete that bullet, what is the risk that this working group creates a standard that requires ALL PDMP data flow to ALL HIEs and ALL EHRs in a region? I've heard many folks say THAT is precisely what "would be the best for patient safety." Yet local regulations may NOT allow such a deployment in every state. Accepted with modification modified the "out of scope" to say trigger as it is the trigger event we are not defining We also modified the last paragraph in the background section to remove the implication of "integrating" the PDMP into the EHR while that is ideal we cannot dictate workflow or what a vender must do to integrate PDMP data into the EHR -- this is also determined by state law and statutes which we cannot address in this project

25. Comments from wiki… John OddenC4UHCommitted Member General Comment Within S&I Framework, there is sometimes a (healthy) bias to "get all available information on the patient in front of each of their providers." When applied to the issue / opportunity / challenge of valuable content generated by Pharmacy Boards via PDMP Reports, we face an interesting challenge. Automated PDMP Report access generally "looks quite a lot alike" across the national footprint. Yet the local nuances of systems (e.g. vendors and customizations) and regulations are significant. How should we shape our collaborative effort in this domain? Would we rather move to standards and methods that are immediately relevant (e.g. "deployable") nearly everywhere? Or are we better advised to imagine and specify a scenario that "does a better job" while also asking EVERY geography to "step up to a truly uniform national method of practice." Given the harsh funding constraints often encountered at pharmacy boards (and other state agencies), THIS Committed Member has a preference for standards and methods that will work in the field, as it exists today. That way, we can see our efforts make a difference quickly, for a larger number of stakeholders. Accepted with modification these are relevant when we look at standards criteria - readiness of standards is among the criteria as is wide spread adoption and maturity - these are typically addressed during harmonization

26. Comments from wiki Tom Langindepen dent Other Interested Party Scope Statement I am an ER physician and have worked on 3 different pilots for PDMP integration with Collaborative for Universal Health. I think that: "Defining method for how the PDMP is contacted or initiated by provider" is important to be considered "In Scope". It is my feeling that the problem to address is "How can we get this information more conveniently into the work flow of those who should be accessing the data?" Accepted with Modification See comments above: trigger event may be out of scope but the technical mechanism for actual exchange is in scope Charlie OltmanTargetCommitted Member Potential Standards for Considera tion Add HIPAA NCPDP Telecommunications standard (D.0). This standard is the real- time adjudicated originating source of truth for all controlled substance claims. accepted Danna DrozNational Associa tion of Boards of Pharma cy Committed Member General Comment Each mention of physician or prescriber should also mention pharmacist. References to writing a prescription should include dispensing a prescription. Transport and Security standards should also include REST. Potential risks may include secondary use of the data by the integrating entity, i.e. skimming, storing, and then selling. persuasive with mod added to glossary

27. Providing Charter Comments 1.Review the Project Charter – http://wiki.siframework.org/PDMP +%26+Health+IT+Integration+Chart er+and+Members http://wiki.siframework.org/PDMP +%26+Health+IT+Integration+Chart er+and+Members 2.Fill out the comment form 1.wiki.siframework.org/PDMP+%26+ Health+IT+Integration+Charter+an d+Members#Commentwiki.siframework.org/PDMP+%26+ Health+IT+Integration+Charter+an d+Members#Comment – All fields are required 3.Submit your comments 4.A Message is displayed verifying your comment was submitted 5.Once you receive the message your comment has been submitted you will be able to view your comment 27 5 5

28. Next Steps Provide comments on PDMP & Health IT Integration Charter Attend weekly “PDMP & Health IT All Hands Meetings” taking place every Tuesday from 12:00-1:00 PM EDT – Next Meeting December 10 th, 2013 Visit PDMP & Health IT Integration Wiki page – All Announcements, Meeting Schedules, Agendas, Minutes, Reference Materials, Project Charter and General Data Access Framework information will be posted on the PDMP & Health IT Wiki page located at: http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+H omepage http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+H omepage 28 NOTE: Please be sure to check the PDMP & Health IT Integration wiki homepage for the most up-to-date meeting information

29. Proposed Community Call Schedule 29 DateMeeting Topics Nov. 19 th, 2013 Community Kick off Meeting Meet the support team Review Project Charter Nov. 26 th, 2013 Continue Review of Project Charter Dec. 3 rd, 2013 Conduct final group review of the project charter Begin end to end review of the project charter Dec. 10 th, 2013 Review end to end comments Fall concert series – OneHealthPortT Begin Consensus process Dec. 17 th, 2013 Review Consensus Comments Fall Concert Series – Presenter TBA Dec. 24th, 2013 Meeting Canceled – Consensus will be announced Dec. 31 st, 2013 Meeting to be determined Fall Concert Series wrap up

30. Questions 30

31. PDMP & Health IT Integration Resources Initiative Wiki Homepage – http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Home page http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Home page Become a Community Member – http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Join+t he+Initiative http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Join+t he+Initiative Project Charter – http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Charte r+and+Members http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Charte r+and+Members Standards and Interoperability(S&I) Framework – http://wiki.siframework.org/Introduction+and+Overview http://wiki.siframework.org/Introduction+and+Overview S & I Calendar of Events – http://wiki.siframework.org/Calendar http://wiki.siframework.org/Calendar 31