1. The NCC is funded by U22MC24100, awarded as a cooperative agreement between the Maternal and Child Health Bureau/Health Resources and Services Administration, Genetic Services Branch, and the American College of Medical Genetics and Genomics. Background And Listening Session: Considering Regional Genetic Care Center Models

2. Regional Genetic Service Collaboratives 7 Regional Genetic Service Collaboratives (6 – 10 states and territories each) To enhance and support the genetics and newborn screening capacity of States –Addresses maldistribution of genetics resources –Promotes translation of genetic medicine into public health and health care services –Shifts services into local communities

3. NCC/RC System Today

4. NCC/RC System Mission Statement The mission of the seven Regional Genetics Service Collaboratives (RCs) and their National Coordinating Center (NCC) is to strengthen and support the genetic and newborn screening capacity of the states and to improve the availability, accessibility, and quality of genetic services and resources for individuals with, or at risk for, genetic conditions and their families. Approved January 2013

5. A Brief History… 1990s: Health and Human Services’ (HHS) sister agencies, Health Resources and Services Administration (HRSA) and Centers for Disease Control and Prevention (CDC), commitment to supporting public health genetics –CDC focused on supporting laboratory testing development –HRSA focused on supporting access to genetic services—Council of Regional Genetic Networks (CORN)

6. HRSA-established CORN (Council of Regional Genetics Networks) Regionalized system to begin organization of genetic services in the US Activities: –Service utilization data –Defining genetic services –Laboratory quality assurance programs –Policy development Limited by means of moving best practices from regional to national level

7. Newborn Screening: The Most Successful Public Health Program And yet…… –Not much uniformity in number and type of conditions screened across states. –Technology utilized in screening varied widely

8. Standardization of Newborn Screening in the United States  In 2001, Maternal and Child Health Bureau (HRSA) charged American College of Medical Genetics  To evaluate the scientific and medical information related to screening for specific conditions  To make recommendations based on this evidence  Expert group convened in December 2002  >70 physicians, scientists, consumers, state laboratorians, lawyers, ethicists, and others  Results reviewed by an independent newborn screening external review group  Newborn Screening: Toward a Uniform Screening Panel and System (report published in 2006) 8

10. 2004 No. of States No. of conditions <5 5-10 11-20 >20 % US Births 20% 42% 12% 27% From NNSGRC (updated 9/8/04) 2002 No. of States No. of MANDATED conditions No. of conditions <5 5-10 11-20 >20 % US Births 30% 66% 0% 5% 5-10 (20%) <5 (20%) 5-10 (66%) <5 (30%)

11. 2010 Status of NBS in the US 100% of US births screened for >30 conditions

12. Uniform Panel for Newborn Screening 2005 Provided the bridge between the CORN system and the Regional Collaborative Defined the uniform panel for newborn screening that was ultimately endorsed by the SACHDNC –Now referred to as the RUSP (Recommended Uniform Screening Panel)

13. Back to the Future Returning to the NCC/RC system as it is today….

14. HRSA Organizational Chart

15. NCC/RC Funding Cycles 2004-present 2004-2007: initial funding under NCC/RC system. (3-year awards, grants) 2007-2012: second funding period (5-year awards, cooperative agreement mechanism) 2012-2017*: third funding period (5-year awards, grants) Total estimated funding for ALL: +/- $50 million * NCC funded for 3 years through a cooperative agreement, and recently awarded a 2-year competitive continuation cooperative agreement through May 31, 2017.

16. Who are the RC Stakeholders? Public Health Professionals (newborn screening, genetics departments) Clinical Services Professionals Laboratorians Consumers, family members Allied Health Professionals Insurers (private and state Medicaid)

17. NCC June 1, 2015 –May 31, 2017 (New Funding Period) 3 Goals of NCC: –Develop a Framework for regional genetic care centers (RGCC) that reflect the needs of diverse regions; –Provide an infrastructure that strengthens communication and collaboration between the RCs, offers technical and clinical expertise as needed, promotes and disseminates outcomes of RC activities of national significance, facilitates partnerships with federal and non-federal entities, and evaluates the impact of RC activities; and –Implement a national genetics education and consumer network (NGECN) that provides access to genomic information and resources that cover the lifespan for consumers and the public.

18. What does the future hold for the NCC/RC system? NCC and RC’s will be simultaneously applying for renewed funding In preparation for this, beginning June 1, 2015, NCC is engaged in a focused, time-sensitive information gathering and data analysis at the regional and national levels regarding the future needs for genetic services This information will help shape NCC and RC’s proposals for the 2017 NCC/RC grants

19. Understanding the gaps and needs Holding listening sessions –How do you define genetic services? –What are existing gaps in genetic services? –We want to hear from you!

20. Understanding the gaps and needs (2) Engaging with national partners around needs assessments (e.g. Title V needs assessments) Utilizing the NCC/RC evaluators through the evaluation workgroup to develop a common core set of needs assessment measures that all RCs will utilize in conjunction with their own needs assessments.

21. Convening a Regional Genetics Care Center Model Workgroup Charge: review existing models of regional care (public health and direct service-based) and develop a recommendation for what regional centers focused on access to genetics care would look like –Focused on those populations that do not have access to genetic services and how to improve their access. Chair: Celia Kaye, MD, PhD Membership: RCs, national experts, clinicians and public health, integrated delivery systems, economics, cross-agency First call—late July 2015

22. Timeline Listening sessions—completed by July 2015 Preliminary presentation of RGCC template— November 2015 PD/PM Meeting National Needs Assessment—completed by December 2015 –Core components across NCC/RC –NCC and NGECN to conduct –Complement, not supplant the RC needs assessment activities Preliminary regional care center model report/template to HRSA—January 2016

24. End Product A Recommended template/plan for a regionalized genetics care center model that reflects the needs of diverse regions and stakeholders By March 2016

25. It’s our turn to listen to you Debbie Maiese, NCC Evaluator, will lead the session and I’ll be taking notes.

26. Thank you! If you have further thoughts/suggestions, Contact us: NCC Project Director, Michael S. Watson, PhD, mwatson@acmg.netmwatson@acmg.net NCC Medical Director, David Flannery, MD, dflannery@acmg.netdflannery@acmg.net NCC Project Manager, Alisha Keehn, MPA, akeehn@acmg.netakeehn@acmg.net NCC Evaluator, Debbie Maiese, MPA, dmaiese@acmg.netdmaiese@acmg.net NCC Project Coordinator, Megan Lyon, BA, mlyon@acmg.netmlyon@acmg.net