1. Federal Health IT Priorities Supporting Nationwide Interoperability February 3, 2015

2. Agenda FHA Overview: Background and Moving Ahead in 2015 FHA Initiatives Federal Direct Messaging Panel Discussion Closing Remarks 2

3. FHA Overview: Background and Moving Ahead in 2015 3

4. FHA Overview Established by the Office of Management and Budget as an E-Government Line of Business (LoB) Initiative Supports federal activities related to the development and adoption of health IT standards and policies Ensures that federal agencies seamlessly and securely exchange health data with other agencies, government entities, and with other public and private organizations 4

5. What is FHA? Currently partnering with more than 20 federal agencies including the Department of Health and Human Services, Department of Defense, Centers for Medicare & Medicaid Services, Department of Veterans’ Affairs, Social Security Administration and Indian Health Services 5

6. Moving Forward Together in 2015 FHA Roles –Coordinate a federal voice for health IT –Frame the transformation to interoperability by defining & articulating elements of the federal health ecosystem –Forge agreements and lead creation/implementation of solutions Collaborate with federal partners to define outcome- based interoperability metrics –Input into the implementation of the Federal Health IT Strategic Plan and Interoperability Roadmap –Harmonize individual federal partner mission metrics Support federal partner priorities and promote success stories with communications outreach 6

7. FHA Strategic Plan – Vision A federal health information technology environment that is fully interoperable and supports the President’s health IT plan enabling better care, increased efficiency and improved population health 7

8. FHA Precepts Capture (Architect federal HIT) –Provide a structured description of the federal health landscape –Version architecture elements for authoritative references (federated architecture) Design (Promote, oversee, coach, pilot potential Shared Services) –Support federal HIE standards implementation and interoperability –Purposefully arrange architecture elements for optimal discovery and use by federal partners Analyze (Gap / Overlap Analyses to derive Shared Service opportunities) –Identify gaps in Health Information Exchanges (HIE) approaches –Guide decision makers on programmatic and strategic initiatives and processes Communicate (Facilitate information sharing to convene best approaches ) –Convey federal position & understanding of complex health interdependencies –Support agencies’ budget requests in health space as coordinated –Coordinate federal participation in identified work groups 8

9. FHA Initiatives 9

10. FHA Initiatives Overview Healthcare Directory Patient Consent & Authorization Architecture Federal Health Information Model CONNECT Directed Exchange 10

11. Healthcare Directory Issues being addressed –ESI for CONNECT and Direct –Directory discovery –Complex query of directories –Federation –Information reliability –Security –Maintenance –Auditing 11

12. Patient Consent & Authorization Issues being addressed –Four levels of sensitivity: national, state, local convention, and as defined by patient –Verification of consent between entities –Policies for opt-in/opt-out –Management of consents and changes –Management of restrictions –Managing the degree of granularity –Security 12

13. FHA Architecture Goals –Capture essential elements of the federal health ecosystem for a shared understanding Federal Health Landscape (As-Is) –Provide authoritative, high-level description of the current environment to support analysis Federal Health IT Ecosystem 2025 (Target) –Facilitate federal partner agency priorities to the national health IT objectives using a data-driven approach Relationship to interoperability efforts –Analytical tool of key ONC, DoD, VA, OGA and industry health initiatives, strategies and roadmaps 13

14. Develop Health-Specific Taxonomies Establish Authoritative References Federal Health Landscape Approach Use standardized representation to understand / improve federal health IT Allows stakeholders to “see” the enterprise, enabling a common understanding 14

15. FHA Strategic Architecture Approach 15

16. Architecture Documentation and Use Modeling using structured frameworks and best practices Stored in database backed repository Refined through collaborative reviews Shared through OMB MAX fileshare 16

17. Federal Health Information Model A logical information model of health data (expressed in UML) developed in collaboration with the federal partners Harmonizes content (information, terminologies and value sets) across federal partners and standards organizations Integrated with open source Model Driven Health Tools (MDHT) to utilize Model Driven Architecture (MDA) to generate HIE Implementation standards for multiple Platform Specific Models (PSMs) (e.g., HL7 CDA, NIEM, HL7 FHIR, etc.) 17

18. FHIM: Benefits/Value Can be utilized to harmonize and standardize data concepts Can be the repository for data concepts –Including and binding of data concepts to terminology systems / value sets (e.g., “Race” -> CDC Race/Ethnicity value set) and the specification of the value sets S&I Framework can leverage the FHIM to more efficiently produce high-quality HIE Standards using automated tools 18

19. CONNECT is a software platform that supports secure health information exchange via Direct and SOAP-based exchanges CONNECT uses ONC Nationwide Health Information Network standards and governance to ensure interoperability with current and future exchanges CONNECT is a cost-efficient, open source solution that is designed to be flexible -- supporting an evolving health data exchange environment What is CONNECT? 19

20. CONNECT Updates CONNECT 4.4.1 –Release date: Jan. 26 –Benefits to the CONNECT Community Change Control Board requirements for 2015 CONNECT Roadmap, Jan. 22 CONNECT 4.5 CONNECT Open Source Community 20

21. Your Comments/ Questions? 21

22. Directed Exchange Inform federal partners about Direct technology, policies and guidelines Develop a common understanding of agency use cases and security requirements Identify, develop and maintain a set of baseline authoritative documents & FAQs Publish common federal agency policy and supporting implementation guidance POC: Eric Larson, federal.health@hhs.gov 22

23. Directed Exchange WG Accomplishments Released Documents –Directed Exchange Guidelines (presentation) Present express, agreed upon recommended guidelines for those entities who wish to exchange Direct messages with the federal partners –Directed Exchange Risk Assessment Identify and prioritize risks or concerns that may inhibit full participation in Direct messaging by federal agencies –Patient Identity in Directed Exchange: How Much Assurance? Generally determine the appropriate level of identity assurance required for a recipient to trust that a received Direct message actually came from a specific patient –Direct Exchange Headers Issue Paper Identify an issue or risk to the message headers from unwanted interception or alteration, and provide recommendations to not avoid the issue but at least be notified when a header was intercepted Find these documents on healthit.gov/fha. 23

24. Directed Exchange WG Deliverables To be completed in 2015… –Federal Common Trust Bundle Checklist for users to use in exchanging data with federal agencies –Directed Exchange Frequently Asked Questions –Directed Exchange White Paper: FHA Certificate Issuance Assurance in Direct 24

25. Federal Direct Messaging Panel Discussion 25

26. Electronic Submission of Medical Documentation (esMD) ONC F2F Federal Health IT Priorities Supporting Nationwide Interoperability February 3, 2015

27. Improper Payment Medicare receives 4.9 M claims per day. CMS’ Office of Financial Management estimates that each year (based on 2014 audit information) -the Medicare FFS program issues more than $47.5 B in improper payments -$29.5 B of improper payment is due inadequate documentation to support payment for services billed -$12.9 B of improper payment is due to services that were not medical necessary based on Medicare coverage policies Over 1.8 million Medical Documentation Requests are sent annually by: -Medicare Administrative Contractors (MACs) Medical Review (MR) Departments -Comprehensive Error Rate Testing Contractor (CERT) -Payment Error Rate Measurement Contractor (PERM) -Medicare Recovery Auditors (formerly called RACs) www.paymentaccuracy.gov

28. PCG/esMD Goals Prevent improper payment through -prior-authorization (e.g. PMD) -pre-payment review Minimize provider burden through -electronic communication of medical information (esMD) -structured data to facilitate review process -digital signatures to establish data integrity and provenance Adopt/promote standards to facilitate information exchange -electronic transaction standards -Messaging standards -Content standards -Digital Signature standards

29. Before esMD Healthcare payers frequently request that providers submit additional medical documentation to support a specific claim(s). Until recently, this has been an entirely paper process and has proven to be burdensome due to the time, resources, and cost to support a paper system. Phase I ) Phase I of esMD was implemented in September of 2011. It enabled Providers to send Medical Documentation electronically. Phase II The ONC S&I Framework Electronic Submission of Medical Documentation (esMD) initiative is developing solutions to support an entirely electronic documentation request. esMD Background

30. CMS esMD Utilizes CONNECT Used by providers for: 1.Unsolicited Documentation 2.Response to Documentation Requests 3.Prior Authorization Demonstration Program over 25% of all documentation is transmitted via CONNECT

31. esMD Interoperability Direction

32. esMD Process Flow

33. S&I Framework esMD Initiative Overview

34. What drives CMS Direct Requirements? 1.Federal Security Requirements –FIPS (Federal Information Processing Standards) –FISMA (Federal Information Security Management Act) –NIST (National Institute of Standards) –FPKI (Federal Public Key Infrastructure) –FBCA (Federal Bridge Certification Authority) –HIPAA (Health Insurance Portability and Accountability Act) 2. Medicare FFS Relationship to Providers – No direct contractual relationship with providers – Providers register with NPPES (National Plan & Provider Enumeration Systems) for NPI – Providers enroll with PECOS (Provider Enrollment, Chain and Ownership System) for Medicare FFS 3. CMS requirements for communication of PHI to providers – Communication containing PHI must be sent to validated endpoint Registered mail address (PECOS or Contractor) Requested endpoint

35. esMD Requirements for Direct 1)Identity-proof individual or organization at FBCA medium (e.g. NIST LOA3 with in-person requirement) “address owner” –Antecedent allowed based on FBCA guidelines –Validate NPI for all providers 2)X.509 v3 certificate (Direct Cert) from FBCA cross- certified CA issued under FBCA CP or equivalent –Direct Cert must include NPI –Direct Cert must be address bound (not domain) 3)HISP must be inspected and accredited (details TBD) 4)Direct Cert must be issued to accredited HISP 5)Direct “address owner” must have a BAA with the HISP 6)Last mile and access must utilize an encrypted transport (should meet current FIPS/FISMA requirements -- e.g. TLS 1.1 minimum) Best Practice (not current requirement) 1)Separate signing and encryption Direct Certs 2)All Direct messages stored encrypted in HISP (including audit logs) 3)Two factor authentication for account access where one factor is a hard token

36. esMD Summary: CONNECT: 1)esMD exchanges more than 500,000 document over CONNECT per year and the volume is growing Direct: 1)Working with FHA on Certificate policies and Federal Trust Bundle 2)Working with DirectTrust to support CMS Direct requirements

37. Closing Remarks 37

38. Additional FHA Roles Create and maintain federal partnerships and liaisons with private sector organizations Federal: HHS, ONC, CMS, DoD, VA, SSA, 17 other federal agencies involved in healthcare Private Sector: Healtheway; DirectTrust; Mayo Clinic; other organizations involved in healthcare Establish a Community Hub Max.gov - Forum for public and private entities to collaborate on health IT solutions Program management and budget IAA’s, MOUs, MOAs Strategic planning 38

39. How Can You Get Involved Today? Use Healthdata.gov as a resource Get actively involved in S&I Framework, HL7, FHIM, and FHA Workgroups 39

40. More about Federal Health IT Initiatives ONC website: www.healthit.gov Direct Project website: www.directproject.org S&I Framework wiki: http://wiki.siframework.org CONNECT website: wiki.connectopensource.org Federal Health Information Model http://www.fhims.org/ 40

41. Stay Connected, Communicate and Collaborate Find out more about FHA on the ONC website: http://www.healthit.gov/FHA http://www.healthit.gov/FHA Schedule a meeting with me or send me your thoughts at: federal.health@hhs.gov federal.health@hhs.gov Subscribe, watch, and share: @ONC_FHA, @CONNECT_Project Federal Health Architecture http://www.flickr.com/photos/federalhealtharchitecture/ 41

42. Stay Connected, Communicate and Collaborate Subscribe to: FHA Weekly Partner Email –A weekly round-up of FHA and appropriate ONC meetings, and relevant industry events The Pulse –A bi-monthly e-newsletter featuring news about FHA and FHA partner activities, and ONC programs 42