PDMP & Health IT Integration Initiative

1. PDMP & Health IT Integration Initiative Initiative Launch November 14th, 2013

2. Meeting Etiquette • Remember: Please 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 = frustrated speakers and participants • This meeting is being recorded • Another reason to keep your phone on mute when not speaking • Use the “Chat” feature for questions, comments and items you would like the moderator or other participants to know. • Send comments to All Panelists so they can be addressed publically in the chat, or discussed in the meeting (as appropriate). From S&I Framework to Participants: Hi everyone: remember to keep your phone on mute  All Panelists 2

3. Agenda

4. Office of Science & Technology Curate a portfolio of standards, services, and policies that accelerate information exchange Enablestakeholdersto come up with simple, shared solutions to common information exchange challenges Teams convened to solve problems Solutions& Usability Coordinate Federal Partners R&D Collaboratewith federal agencies to coordinate federal health IT priorities as manager of Federal Health Architecture Support Innovation through SHARP program, Innovation/Challenge Grants, and interfacing with International Standards community

5. ONC’s Interoperability Strategy • Leverage government as a platform for innovation to create conditions of interoperability • Health information exchange is not one-size-fits-all; create a portfolio of solutions that support all uses and users • Build in incremental steps – “don’t let the perfect be the enemy of the good”

6. What is the S&I Framework? • The Standards and Interoperability (S&I) Framework represents one investment and approach adopted by the Office of Science & Technology (OST) to fulfill its charge of prescribing health IT standards and specifications to support national health outcomes and healthcare priorities • The S&I Framework is an example of “government as a platform”– enabled by integrated functions, processes, and tools – for the open community* of implementers and experts to work together to standardize * As of October 2013, 2000+ people had registered on the S&I Framework wiki, and 750+ members representing 550+ organizations had committed to the S&I Framework

7. S&I Framework Coordination FACAs • HIT Standards Committee • HIT Policy Committee • Tiger Team Community S&I Framework SDOs • Technology Vendors • System Integrators • Government Agencies • Industry Associations • Other Experts • HL7 • IHE • CDISC • NCPDP • ASC X12 • ASTM • WEDI • ISO/TC 215 • IHTSDO • NLM • NQF • Regenstrief • Other health IT standards related organizations ONC Programs & Grantees • State HIE Program & CoPs • SHARP Program • REC Program & CoPs • Beacon Program

8. S&I Framework Overview • Specific health interoperability initiatives guide the design and development of a fully integrated and connected health information system • An S&I Initiative focuses on a single challenge with a set of value-creating goals and outcomes, and the development of content, technical specifications and reusable tools and services • Call for Participation: The overall success of the S&I Framework is dependent upon volunteer experts from the healthcare industry and we welcome any interested party to get involved in S&I Framework Initiatives, participate in discussions and provide comments and feedback by joining the Wiki: http://wiki.siframework.org

9. Prescription Drug Abuse Prevention The National Perspective November 14, 2013 S&I PDMP Kickoff Dr. Cece Spitznas Office of Research and Data Analysis Office of National Drug Control Policy

10. The U.S. Prescription Drug Abuse Problem • 6.8 million Americans reported current non-medical use of prescription drugs in 2012.1 • Approximately 1 in 4 people using drugs for first time in 2012 began by using a prescription drug non-medically.2 • Of the 38,329 drug overdose deaths in 2010, approximately 22,100 involved prescription drugs. • 16,651 involved opioid painkillers (vs. 4,183 for cocaine and 3,038 for heroin)3 • $55.7 billion in costs for prescription drug abuse in 20073 including $25 billion in direct health care costs and $5.1 billion in criminal justice costs.4 • Studies have found that individuals abusing opioids generate, on average, annual direct health care costs 8.7 times higher than non-abusers.5 1, 2. Substance Abuse and Mental Health Services Administration. Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings. U.S. Department of Health and Human Services. [September 2013]. Available: http://www.samhsa.gov/data/NSDUH/2012SummNatFindDetTables/NationalFindings/NSDUHresults2012.htm 3. CDC, National Center for Health Statistics. Multiple Cause of Death 1999-2010 on CDC WONDER Online Database. Extracted May 1, 2012. 4. Birnbaum HG, White, AG, Schiller M, Waldman T, et al. Societal Costs of Prescription Opioid Abuse, Dependence, and Misuse in the United States. Pain Medicine. 2011;12:657-667. 5. White AG, Birnbaum, HG, Mareva MN, et al. Direct Costs of Opioid Abuse in an Insured Population in the United States. J Manag Care Pharm. 11(6):469-479. 2005

11. U.S. Death Rate Trends, 1980-2010 Source: NCHS Data Brief, December, 2011, Updated with 2009 and 2010 mortality data

12. National Drug Control Strategy • The President’s science-based plan to reform drug policy: • Prevent drug use before it ever begins through education • Expand access to treatment for Americans struggling with addiction • Reform our criminal justice system • Support Americans in recovery • Coordinated Federal effort on 112 action items • Signature initiatives: • Prescription Drug Abuse • Prevention • Drugged Driving

13. Prescription Drug Abuse Prevention Plan • Coordinated effort across the Federal Government • Four focus areas: • Education • Prescription Drug Monitoring Programs • Proper Medication Disposal • Enforcement

14. Overdose Deaths, Specific Drugs, 1999-2010 Source: CDC/NCHS National Vital Statistics System, CDC Wonder. Updated with 2010 mortality.

15. Source of Prescription Pain Relievers Source: SAMHSA, Center for Behavioral Health Statistics and Quality, National Survey on Drug Use and Health, 2009-2010

16. Emerging Issues: Prescription Opiates and Heroin • The number of primary admissions among 18- to 24-year-olds for heroin treatment services increased from 34,000 in 2000 to 60,000 in 2011.1 • The number of persons who were past-year heroin users has been rising steadily, increasing approximately 50 percent since 2008 (445,000 to 669,000 in 2012).2 • Injection-drug users report prescription opioid use predates heroin use and tolerance motivates them to try heroin.3 Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration, Treatment Episode Data Set (TEDS). Data extracted as of September 2013. Substance Abuse and Mental Health Services Administration, Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-44, HHS Publication No. (SMA) 12-4713. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2012.linked to 2/13/2013 http://www.samhsa.gov/data/NSDUH/2k11Results/NSDUHresultsAlts2011.htm#Fig2-4 pending citation/cleared data Lankenau SE, et al. (2012). Initiation into prescription opioid misuse amongst young injection drug users. Int J Drug Policy. 2012 Jan;23(1):37-44. Epub 2011 Jun 20.

17. State Overdose Death Rates, 2010 — U.S. National Rate: 12.3 per 100,000 — 10.9 Source: Centers for Disease Control and Prevention, National Center for Health Statistics. Underlying Cause of Death 2000-2010 on CDC WONDER Online Database. Extracted October, 2012.

18. Monitoring Goals • PDMP in every state and interoperability among states. • Use of the system by prescribers to identify patients potentially at risk for or engaged in prescription drug misuse or at risk for medication interaction. Main Actions • Secured language for Department of Veterans Affairs to share prescription drug data with state PDMPs. • Currently 16 states can share data across state lines. • Pilot projects with ONC and SAMHSA in Illinois, Indiana, Kansas, Michigan, Nebraska, North Dakota, Ohio, Oklahoma, Tennessee, and Washington state.

20. PDMP Overview and Federal Efforts H. Westley Clark, MD, JD, MPH, SAS, FASAM Director Center for Substance Abuse Treatment Substance Abuse and Mental Health Services Administration PDMP & Health IT Integration Initiative Launch Webinar November 14, 2013

21. What are PDMPs? • Many states established PDMPs to reduce prescription drug abuse and diversion. • Statewide electronic databases: • Collect data on controlled substances dispensed by pharmacies (and dispensing physicians in some states). • Distribute patient health information from the database to individuals authorized under state law.

22. PDMP Data Fields • Data collected varies by state, may include: • Schedules II-IV (some V) • Prescriber • Dispenser • Patient • Date dispensed • Drug • Strength • Quantity • Refills • Method(s) of payment

23. PDMP Applications & Reporting Types • PDMPs may be used for: • Clinical support • Regulatory Oversight • Surveillance and Evaluation • Law Enforcement • Reporting Types: Passive vs. Proactive • Solicited Reporting (Pull model) • Unsolicited (Push model) 1 2 DIRECT protocol

24. State Snapshot: PDMPs • 49 States have legislation authorizing PDMPs. • 47 States have operational PDMPs. • In MO, privacy concerns are 1 reason for push back on legislation.* http://www.pdmpassist.org/pdf/pmpprogramstatus2013_a.pdf *http://www.komu.com/news/prescription-drug-monitoring-program-may-curb-state-drug-abuse/

25. State Snapshot: PDMP Interoperability • 20 States are engaged in interstate data sharing (9/19/13). • A PDMP may be sharing data with one or more other PDMPs. http://www.pdmpassist.org/pdf/PDMP_interoperability_status_21030919.pdf

26. The Story So Far Federal & State Partners Action Plan: Improving Access to PDMPs through HIT State Participants Stakeholders White House Roundtable on Health IT & Prescription Drug AbuseJune 3, 2011 Organizations

27. Action Plan Implementation • SAMHSA provided funding for implementation of the Action Plan through the “Enhancing Access to PDMPs through Health IT Project”. • SAMHSA partnered with ONC, ONDCP, & the CDC. • ONC has management oversight of the effort.

28. Enhancing Access to PDMPs through Health IT Project • Goal: Increase timely access to PDMP data in an effort to reduce prescription drug misuse and overdoses. • Explore ways to use HIT to link prescribers and dispensers with the valuable data in PDMPs. • Main issue: How to make this information more available to three key groups of clinical decision makers:

29. Enhancing Access to PDMPs through Health IT Project Work Groups Provide recommendations and pilot input Pilots Test the feasibilityof using health IT to enhance PDMP access Reduce prescription drug misuse and overdose in the United States

30. Current Federal PDMP Initiatives • Inclusion of prescribing data from Federal dispensers • Providing technical assistance to states and others • PDMP evaluations • Planning, Implementation, and Enhancement grants • Health Information Technology and PDMP Pilot programs • PDMP EHR Grant Programs

31. SAMHSA’s PDMP EHR Grants • Improve real-time access to PDMP via existing technologies like EHRs (FY12,13). • Strengthen operational state of PDMPs by increasing interoperability between states (FY12). • Evaluate the impact of the enhancements on Rx drug abuse (FY12). • FY 12: 2 year funding for 9 states (FL, IL, IN, KS, ME, OH, TX, WA, WV) • FY 13: 2 year funding for 7 states (KY, MA, ND, NY, RI, SC, WI)

32. SAMHSA’s PDMP EHR Grants:Overview of Phase 1 Pilots

33. SAMHSA’s PDMP EHR Grants:Overview of Phase 2 Pilots

34. Key Takeaways of Enhancing Access Project • Integrating into provider workflow reduces barriers to PDMP access and increases utilization. • Type of integration can vary: • Value increases with degree of automation; • But even basic integration (hyperlink to PDMP, return PDF) is valued. • When available, the PDMP is valuable as a clinical decision support tool.

35. Enhancing Access Project Accomplishments: Phases 1 & 2 • Enhancing Access Pilot White Papers: 8 papers detailing each pilot’s design, technical configuration, outcomes, and plans for expansion. • The Road to Connectivity: A roadmap for connecting to PDMPs through health IT. • Workgroup Recommendations Final Report: Stakeholders identified challenges and recommended solutions to increase timely use of PDMP data by clinicians. • Videos: Pilot participants detail their individual battles against prescription drug abuse, recalling how they used health IT to connect providers to PDMPs.

36. Enhancing Access Project Accomplishments: Phases 1 & 2 (cont.) • PDMP Connect Web Site: Developed to allow members of the PDMP community to share valuable experiences, information, and resources: http://www.healthit.gov/pdmp/pdmpconnect • Abbreviated S&I Initiative: Conducted Jan – March 2013: • It provided valuable feedback from stakeholders, but only identified where standards were needed and the potential standards that could be used. • It did not identify, evaluate, and harmonize standards for the exchange of information from PDMP to EHRs or HIEs, which we will address in Phase 3…

37. THANK YOU! Westley.clark@samhsa.hhs.gov

38. Phase 3: Next Steps & Call for Participation Doug Fridsma, ONC

39. Situation Today • Low utilization of PDMPs among healthcare providers: • Lack of awareness/utility • Many PDMPs are stand alone systems / No system-to-system interface • Outside of the clinical workflow • Time and complexity required to access • Lack integration • Untimely data • EHR Adoption: • As a result of the increased use of EHRs, integrating PDMP data into EHRs is critical to improving PDMP access and utilization. • Opportunity to leverage PDMP to improve patient safety, by integrating PDMP information into clinical decision support, medication reconciliation, and quality improvement

40. PDMP & Health IT Integration Initiative moving forward • While there are data exchange standards in place to share information • PDMP to PDMP • Pharmacy to PDMP • EHR to Pharmacy (eRx) • Currently there is not a national uniform approach to the exchange of data between an EHR and a PDMP.

41. PDMP Ecosystem EHR System EHR System EHR System Needs for consistent harmonized standards (data format and content; transport and security protocols) Pharmacy NCPDP Script Provider Provider Provider Data Out PDMP ASAP NCPDPTelecom Portal Switches NIEM-PMP NIEM-PMP Pharmacy Benefits Mgmt PMPi / RxCheck PDMP Other State PDMPs

42. Interoperability Challenges • One of the current technical barriers to interoperability is the lack of harmonized standard methods to exchange and integrate the prescription drug data available in PDMPs into health IT systems. • Lack of harmonized technical standards and vocabularies to enable PDMPs to share computable information with the EHR that providers can use to support clinical decision-making. • To achieve interoperability, consistent and standardized electronic methods need to be established to enable seamless data transmission between PDMPs and health IT systems.

43. Now and Then Enhancing Access to PDMPs using Health IT project – Phases 1 & 2 • September 2011 - March 2013 • Pilots demonstrated proof of concept. • Various non-standard approaches were also used that need to be refined or harmonized with the existing portfolio of standards and implementation specifications. • Abbreviated S&I Initiative (Jan – March 2013) • Did not identify, evaluate and harmonize standards for the exchange of information from PDMP to EHRs or HIEs. • Valuable feedback from stakeholders but only identified where standards were needed and the potential standards that could be used. PDMP & Health IT Integration Initiative –Phase 3 • November 2013 – TBD • Full S&I Framework Initiative • Assess the current PDMP infrastructure (e.g., interfaces, data formats, data transport and data security protocols) and available standards that could be harmonized to allow interoperable communications between PDMPs and health IT systems.

44. PDMP & Health IT Integration Initiative Support Team • Initiative Coordinator: Johnathan Coleman • Co-Coordinators: TBD • ONC Sponsors: • Jennifer Frazier • Mera Choi • Scott Weinstein • SAMHSA Lead • Jinhee Lee • Kate Tipping • Project Management: Jamie Parker • Project Support: Ali Kahn • Use Case Lead:Presha Patel • Use Case Support: AhsinAzim • Vocabulary and Terminology Subject Matter Expert: Mark Roche

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

46. Logistics • We will be meeting as a community every week on Tuesdays12:00-1:00 pm ET. • All Announcements, Meeting Schedules, Agendas, Minutes, Reference Materials, Use Case, Project Charter and General PDMP & Health IT Integration information will be posted on PDMP & Health IT Integration Initiative: • http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Homepage

47. PDMP & Health IT Integration Wiki Home Page • Join us for our next Work Group Meeting November 19th, 2013 • See the wiki page for the meeting updates • http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Homepage PDMP & Health IT Integration Wiki

48. Next Steps… • The PDMP & Health IT Integration Initiative is open for anyone to join • This community will meet frequently by webinar and teleconference • We use Wiki pages to facilitate discussion. Information on how to join the Community can be found on the PDMP & Health IT Integration Initiative: • http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Homepage • In order to ensure the success of our initiative and the subsequent pilot, we encourage broad and diverse participation from the community. • This is your chance to have an impact on the creation and implementation of a pilot program in this important area of health IT development

49. Next Steps continued • Please comment on the Proposed Project Charter • Review the Project Charter: • http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Charter+and+Members • Complete the PDMP & Health IT Charter Comment Form (scroll to the bottom of the page): • http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Charter+and+Members • Join us for our next meeting November 19, 2013 from 12:00-1:00 pm ET • The time and meeting information will be available on the PDMP & Health IT Integration wiki page: http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Homepage • Details on the PDMP & Health IT Integration launch including web meeting access and call in information are posted on the wiki: • http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Homepage

50. Questions and Open Discussion