Da Vinci Program Overview September 2018 AWG

Interim Antitrust Policy ANSI Antitrust Policy ANSI neither develops standards nor conducts certification programs but instead accredits standards developers and certification bodies under programs requiring adherence to principles of openness, voluntariness, due process and non-discrimination. ANSI, therefore, brings significant, procompetitive benefits to the standards and conformity assessment community. ANSI nevertheless recognizes that it must not be a vehicle for individuals or organizations to reach unlawful agreements regarding prices, terms of sale, customers, or markets or engage in other aspects of anti- competitive behavior. ANSI’s policy, therefore, is to take all appropriate measures to comply with U.S. antitrust laws and foreign competition laws and ANSI expects the same from its members and volunteers when acting on behalf of ANSI. Approved by the ANSI Board of Directors May 22, 2014 Note: always clear/include antitrust statement in a public meeting.

Objective To ensure the success of the industry’s shift to Value Based Care there is a need to establish a rapid multi-stakeholder process to identify, exercise and implement initial use cases between payers and provider organizations. The objective is to minimize the development and deployment of unique solutions with focus on reference architectures that will promote industry wide standards and adoption. Components for success include (and where needed, create extensions to or craft revisions for) common: Standards (HL7 FHIR®), Implementation guides, and Reference implementations and pilot projects to guide the development and deployment of interoperable solutions on a national scale. Da Vinci simply is an group of industry payers, providers and HIT partners that understand how critical it is to develop common, ideally eventual standard ways for providers and payers to exchange the critical data required for value base case to work. 3

VBC Programs Drive Focus to Patient Outcomes Cost Constraints Regulatory Impact Enable provider to see right data at right time for specific patient coverage, benefits and care coordination Historically, payment and coverage data completely separate from care VALUE We’ve all seen version of triple aim, I pause here to simply say focusing on value, really puts improving outcomes on more equal footing as following rules and cost savings. It is critical a provider understand at point of services the specific information about individual patient, given increase complexity of coverage, networks and increasing cost to consumer in high deductible, risk sharing plans. We can no longer ask patient/providers to look at billing as a retrospective exercise, providers and patients increasingly must understand cost and quality impacts as part of clinical path. Historically, payment and coverage a separate workstream, disconnected from patient clinical care.

Empower End Users to Shift to Value As a private industry project under HL7 International, Da Vinci will unleash critical data between payers and providers required for VBC workflows leveraging HL7® FHIR® So this is a journey, not immediate change, increasingly providers and the extended care team must have access while caring for a patient, as triggers or integrated in their workflows. While the shift from Fee for Service to paying based on outcomes is a giant shift in US healthcare, this is not a US centric problem. We believe FHIR is best option at this time to get providers across this chasm. Source: © 2018 Health Catalyst

Work Underway to Identify Initial Sites by Use Case Founding Members 12 Payers 3 EHRs 9 Use Cases 10 HIT Vendors Our initial founding group of payers, providers and HIT vendors has grown to a membership group of 27 organizations, including 12 payers, 10 HIT vendors, 6 providers and 3 EHR vendors.  Cross-functional teams are currently involved in the project to develop and deploy FHIR-based solutions that positively impact clinical quality, cost and care management outcomes. We’ve paused on adding addition members , but all artifacts including IGs, reference implementations and pilot partners will be open source and available to public. ½ Dozen Providers Work Underway to Identify Initial Sites by Use Case

2018 Use Case Inventory and Project Deliverables Medication Reconciliation Post-Discharge Measure* Coverage Requirements Discovery* Documentation Templates and Coverage Rules** Project Deliverables Define requirements (technical, business and testing) Create Implementation Guide Create and test Reference Implementation (prove the guide works, with working software code) Pilot the solution Deploy the solution eHealth Record Exchange: HEDIS/Stars & Clinician Exchange** Notification (ADT): Transitions in Care, ER admit/discharge Risk Based Contract Member Identification Thousand of potential use cases available. HL7 and thought leaders representing payers and CMS in coordination and working with groups like HL7 Partners in Interoperability meetings identified initial need for common workflows for Value Based Care led to identification of initial priorities. Further fleshed out with input from early founders. Focus – Use cases looking for high volume, manual activities that would benefit from automation of portions of workflow that collect critical data to improve outcomes. Authorization Support Quality Measure Reporting Laboratory Results * In active development and testing ** Discovery and requirements underway 7

x Da Vinci 2018 Use Cases – Phase 1 Use Case 4* Use Case 3 Use Case 2 Program Start Up Dec Jan Feb March April May June July Aug Sep Oct Nov Dec Simple timeline and Establish Project Test Use Case 1 Concepts Test Use Case 3 Reference Implementation Test Use Case 1 & 2 Reference Implementation Test Use Case 2 &3 Concepts Prelaunch Use Case 1 Use Case 2 Use Case 3 Use Case 4 8 * Pending final approval.

Goal is to develop repeatable production focused projects Project Deliverables Implementation Guide (IG) A specification that defines how the capabilities defined by the FHIR specification are used in particular data exchanges, or to solve particular problems (adapted from the HL7 FHIR Foundation Implementation Guide Registry (http://www.fhir.org/guides/registry)) Reference Implementation (RI) A reference implementation is, in general, an implementation of a specification to be used as a definitive interpretation for that specification . During the development of the conformance test suite, at least one relatively trusted implementation of each interface is necessary to (1) discover errors or ambiguities in the specification (2) validate the correct functioning of the test suite. Characteristics of a Reference Implementation: Developed concurrently with the specification and test suite; Verifies that specification is implementable; Enables the test suite to be tested; Serves as a Gold Standard against which other implementations can be measured; Helps to clarify the intent of the specification in situations where conformance tests are inadequate Goal is to develop repeatable production focused projects

Program Construct

Governance Structure STEERING COMMITTEE OPERATING COMMITTEE Payers -3 Providers - 2 IT Vendors- 2 CMS* - 1 HL7 - 1 Program Manager & Technical Director OPERATING COMMITTEE STEERING COMMITTEE Senior level executive, can make decisions and commit organization resources Driving interoperability strategy within home organization and responsible for coordination with industry Technology and business ownership to drive “business case” approval OPERATING COMMITTEE Budget planning and approval for “in kind” and project fees Leader and/or influencer across home organization Work closely/aligned with senior leadership at home organization, can queue up commitment and decisions and drive to conclusion Understands and will own HL7 standards relationship, commitments Roll up sleeve and problem solve use case development and inventory, priorities, details Identify and gain access/time for “in kind” resources for priority use case work Use Case 1 Project Lead Use Case 2 Project Lead Use Case n+ Project Lead 11 *CMS (Medicare Fee Service)

TRUE INTEROPERABILITY Build Your Organization Pilot Use Cases - Recommend Payer Provider Tools + + = Payer Provider Reference Software TRUE INTEROPERABILITY Multiple payers working with each provider organization, using the same common software code, via FHIR is the objective of the Da Vinci pilot projects Payer Provider Implementation Guide Build Your Organization 12

Project Structure & Timeline Represents 4 weeks 2-4 sprints IG Development Specify profiles, … IG Framework Create Draft IG Revise and Finalize IG FHIR Gap Analysis Assemble Team Requirements RI Tech Approach Project start Build Initial RI Test RI Update Final RI RI Development Build Data Set Build Test Set Week 0 2 4 6 8 10 12 14 16 Work with appropriate HL7 workgroup for IG sponsorship and input

Use Case 1: Medication Reconciliation Post-Discharge

Data Exchange for Quality Measures (DEQM): Medication Reconciliation Post-Discharge (MRP) Acute Care Need for provider to attest that Med Rec has been completed post-discharge Increasingly required for HEDIS and commercial at risk contracts Focus is to document the comparison of pre/post medication lists to avoid errors Today done through claims processing or manual review of lists 1. Discharge Notification Payer 2. Med Rec Need Provider Today’s manual and ad hoc processes are costly and will not scale. Using FHIR to unlock silos of this critical

Data Exchange Quality Measure: Implementation Guide 1. Submit Use case creates a common framework for quality data exchange Enables the exchange of raw quality measure data between quality measurement Teams and Care teams that provide patient care Timely exchange of key data is critical to evaluate and capture quality Future work will incorporate additional use cases 2. Collect 3. Subscribe

Use Case 2: Coverage Requirements Discovery

Coverage Requirements Discovery Provider Providers need to easily discover which payer covered services or devices have Specific documentation requirements, Rules for determining need for specific treatments/services Requirement for Prior Authorization (PA) or other approvals Specific guidance.   With a FHIR based API, providers can discover in real-time specific payer requirements that may affect the ability to have certain services or devices covered by the responsible payer.  Response may be The answer to the discovery request A list of services, templates, documents, rules URL to retrieve specific items (e.g. template) Order Procedure, Lab or Referral Discover Any Requirements Payer

Coverage Requirements Discovery Implementation Guide 1) Based on a specific clinical workflow event: scheduling, start of encounter, planning treatment, ordering, discharge Provider’s send FHIR based request, with appropriate clinical context to the responsible payer 2) Payer may request additional information from the provider EHR using existing FHIR APIs 3) Payer responds to the EHR with any specific requirements that may impact the clinical decisions or coverage Provider utilizes this information to make treatment decisions while considering specific payer coverage requirements. Provider requests coverage requirements from payer Optional: request additional information Payer responds to the request Provider Payer

Project Milestones

x Da Vinci 2018 Program View Actual Milestone - Public Access Coverage Rules and Document Templates x Coverage Requirements Discovery Core Da Vinci Team 30 Day Medication Reconciliation Program Start Up Dec Jan Feb March April May June July Aug Sep Oct Nov Dec Test Use Case 1 Concepts Test Use Case 1 & 2 Test Use Case 2 & 3 Establish Project Test Use Case 3 Project Scope Statement Notice of Intent to Ballot All final artifacts submitted to HL7 HL7 Activities to Support Use Case 1 and 2 This is the work of the Da Vinci paid staff members with support from members. ONC Listening Sessions DQS Track Leadership & Podium HIMSS Podium Dev4Health Podium DevDays Podium Events & Communication Press Release & Collateral 2.0 HL7 Annual TBD Collateral 1.0 WEDI Podium 21 Prelaunch Use Case 1 Use Case 2 Use Case 3 Use Case 4

Resources Da Vinci Public Site Background collateral Implementation Guide Published 8/24 through HL7 balloting process Reference Implementation – Available at Sept 29 & 30th to HL7 Connectathon participants Revised version publicly available post HL7 Follow Progress, Test, Implement 30 Day Med Rec: http://confluence.hl7.org/display/DVP/30+Day+Medical+Reconciliation Coverage Discovery Requirements : http://confluence.hl7.org/display/DVP/Coverage+Discovery+Requirements

Upcoming Use Cases

Documentation Templates and Payer Rules Providers need to easily incorporate payer requirements into their clinical workflow Specific documentation requirements, Rules for determining need for specific treatments/services Requirement for Prior Authorization (PA) or other approvals Specific guidance.   Use a FHIR based standard for representing payer “rules” to communicate, in real-time, payer medical necessity and best clinical practice requirements that may affect the ability to have certain services or devices covered by the responsible payer.  The template/rules may (examples, not complete list) Specify provider documentation requirements for coverage, medical necessity Provide guidance / documentation requirements regarding social determinates that are antecedents for specific care Collect information for some purpose (e.g. authorizations) Indicate clinical requirements including appropriate use Collect specific documentation for Quality Measures Respond with specific information as requested/documented in the template/rules

eHealth Record Exchange Potential Scenarios HEDIS/STARS – exchange for quality measures Gaps in Care – exchange to facilitate determination of gaps in care Care Planning – exchanges to facilitate the management of care plans across multiple contributors Support for chronic and acute conditions Support for home health services (e.g. Home Health Plan of Care) Orders and Medical Record Exchange (or specific subsets) Laboratory orders and results

Program Contacts Da Vinci Program Manager: Jocelyn Keegan, Point of Care Partners jocelyn.keegan@pocp.com Da Vinci Technical Lead: Dr. Viet Nguyen, Stratametrics LLC vietnguyen@stratametrics.com Coverage Related Use Case Leadership: Robert Dieterle, EnableCare rdieterle@enablecare.us