Sustainable Entity Update #2 Discussion Document 2016-12-23

Background PCORI held a sustainability focus group in Nashville, TN on 11/28/2016 During the meeting, a new Sustainable Entity Team was launched (Composition: Hernandez, Fleurence, Rothman, Margolis, Kaushal, Terry, and Forrest) This document is the 2nd update of the team’s work

Sustainable Entity Team Work Groups Organizational design, Legal and By-Laws (focus of this update) Business Model and Plan Membership Engagement/Network Core Strategy and Operations

Sustainable Organizational Design 3 Components Networks Coordinating Center(s) with service cores NewCo with a Program Office Consortium of Networks Each network may be a collection of institutions and/or communities Coordinating Center(s)/Service Cores Coordinate and conduct common activities across the consortium and provide specialized services in a functional service model NewCo/Program Office New entity that will be a company and serve as the administrative unit of the sustainable entity

Consortium of Networks PCORnet CDRNs and PPRNs will be encouraged to apply for membership in the sustainable entity’s network consortium Forthcoming: Membership workgroup membership model We will not carry forward the PPRN and CDRN labels

Support people-centric and people-driven research All Networks Support people-centric and people-driven research Engage stakeholders Develop people-informed research priorities Do Research

Institutional Networks Engage stakeholders in research Data Network: maintain the PCORnet common data model (CDM) and run queries Research: participate in one or all of the following: research using the CDM, prospective clinical studies/trials, health system analytics, implementation science NewCo Support: willing to allow a portion of revenue to support the program office and its contracted service cores/coordinating centers Scientific Resource: provide scientific leadership for studies and serve as a resource for studies that the networks do not lead National Utility: willing to be part of a national evidence generation platform

Community Networks Engagement: composed of activated and empowered communities of participants and clinicians Research: initiate and participate in prospective clinical studies/trials, and observational research using registry data Service Core Support: an engagement/network service core will provide tools and services (at a fee) to strengthen networks’ engagement, research capacity, and maturation

Benefits of Sustainable Entity for Community Networks Business development  Access to standards developed and maintained by NewCo (governance, policies, data, regulatory, administrative) Access to institutions for network-generated research Access to network design and development services via the Engagement/Network Core Participation in the learning community of networks Sharing of best practices using the Commons Access to a technology platform that lowers the cost of maintaining the network’s registry (future state)

Community Network Benefits for the Sustainable Entity People-generated research priorities Research-ready communities strengthen business development Greater research impact Results will be immediately implemented by the community networks Provide value to institutional leaders interested in impact and speed to impact One of the distinguishing characteristics of the sustainable entity

Ways that Community Networks Generate Revenue Front door generates business that requires involvement of Community Networks (CN) only NewCo/Program Office “tax” revenue from this business Front door generates business that involves collaboration between CN and Institutions Some revenue supports Program Office/NewCo Some revenue to institutions Some revenue to CNs Pricing determined by program office; front door leads may come via central front door or via the networks themselves

Coordinating Center(s) & Service Cores NewCo will contract with Coordinating Center(s) and service cores Functions or services may be across 1 or more institutions to allow functional and flexible service model Common functions/services with standardized procedures may include: Data and query fulfillment Engagement/Network Research/Clinical Trials Clinical Operations Project Management Specialized service cores may provide expert or concentrated activities

Collaborative Research Groups Could be maintained in the Network Consortium as a strategy for organizing expertise, participants/clinicians/scientists, and research catalysts How they are best integrated into the emerging design is an open area for discussion

NewCo/Program Office Sustainable entity will include a new company, NewCo NewCo will serve as the program office for the Network Consortium Functions include: Business development, including front door activities (most important) Standards management Governance support (of the Board and for the members) Legal and Regulatory Contracting Management of the Network Consortium

NewCo - Continued 501(c)(3) not-for-profit entity Founded with a small Board of Directors and a start-up staff, including an Executive Director To set this up: Choose a name for NewCo, name the founding Board of Directors (n=3 to 5; grow to 11-13 over time) Incorporate with a 2-page document called Articles of Incorporation Apply to IRS for tax-exempt status (takes 9 months) Board ratifies by-laws Obtain start-up funds for staff Set up a bank account

Governing Board – Initial Thoughts Ensure activities are mission-aligned and supporting patient-centered national evidence generation platform Reviews mix of industry / foundation / and federally funded studies Composition: 3 – 13 members, target = 9 to 11; considering an initial BoD of n=5