State-wide criteria for Stroke Center Certification & Designation

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1 State-wide criteria for Stroke Center Certification & Designation Vallabh Janardhan, MD FSVIN Chair, SVIN Stroke Center Certification Workshop Founding Board of Director & Treasurer, SVIN Director, Texas Stroke Institute

2 Data Safety Monitoring Board Member, Penumbra Pivotal Trial, Penumbra Inc., Consultant Board Member, Insera Therapeutics Inc., Stocks/Stock Options National Science Foundation Grant # Principal Investigator FIRST Trial, Penumbra Inc., Principal Investigator Chandril Chugh, MD Tanzila Shams, MD MHA Disclosures Acknowledgements

3 Overview 1 Stroke Designation 2 Statewide Stroke Legislation 3 Statewide Stroke Certification 4 Brain attacks: Lessons learned from heart attacks

4 Stroke Designation

5 Stroke Designation: Why do we need it? 1 Ensure high quality care for brain attack patients 2 3 Assist EMS in triaging stroke patients to the appropriate hospital 4 Provide State oversight of third party Stroke center certifying bodies Comply with State Legislation for Stroke Designation and Triaging

6 Stroke Certification & Designation: How do we get there? Self Certification by State Hospitals - NOT Certified Certified Stroke Centers Move from Self-certification to embracing third party Stroke center Certifying bodies (TJC, DNV, HFAP etc.) Pass appropriate State Legislation mandating Stroke Designation and Triaging

7 Statewide Stroke Legislation

8 Stroke Designation: States with Enacted Legislation Enacted Legislation Have supporting legislation Pending legislation WA OR NV CA ID AZ UT MT WY CO NM ND SD NE KS OK MN IA MO AR WI NY MI PA OH IL IN WV VA KY NC TN SC MS AL GA VT NH NJ DE MD ME CT RI MA TX LA FL AK HI 14 States have enacted legislation mandating stroke center designation & triaging plans

9 Stroke Designation: States with Pending Legislation Enacted Legislation Have supporting legislation Pending legislation WA OR NV CA ID AZ UT MT WY CO NM ND SD NE KS OK MN IA MO AR WI NY MI PA OH IL IN WV VA KY NC TN SC MS AL GA VT NH NJ DE MD ME CT RI MA TX LA FL AK HI 2 States have pending legislation mandating stroke center designation & triaging plans

10 Stroke Designation: Legislation in House Bethany Hall-Long (D) Delaware (2009) House Bill 378 Robert A. Biggins (R) Illinois (2009) House Bill 2244 Robert W. Cooper (R) Missouri (2008) House Bill 1790 Conrad James (R) New Mexico (2012) House Bill 33 Todd Porter (R) North Dakota (2009) House Bill 1339 Kathy Hawken (R) North Dakota (2009) House Bill 1339 Lois Delmore (D) North Dakota (2009) House Bill 1339 Eileen S Naughton (D) Rhode Island (2009) House Bill 5798 Philip A. Hamilton (R) Virginia (2008) House Bill 479 Dawn Morrell (D) Washington (2010) House Bill 2396

11 Stroke Designation: Legislation in Senate State Senators who have enacted legislations for stroke designation Pending Stroke legislation Mike Fasano (R) Florida (2004) Senate Bill 1590 Dr. Don Thomas (R) Georgia (2008) Coverdell-Murphy Act David L. Williams (R) Kentucky (2010) Senate Bill 1 Daniel A. Wolf (D) Massachusetts Senate Bill 840 (Pend) Roman W. Prezioso (D) West Virginia Senate Bill 581 (Pend) State Senators who have enacted legislations for stroke designation Barbara A. Boone (D) New Jersey (2004) Senate Bill 477 Joseph Carraro (R) New Mexico (2005) Senate Bill 190 John Sparks (D) Oklahoma (2008) Senate Bill 1420 Dr. Bob Deuell (R) Texas (2005) Senate Bill 330

12 House or Senate Bills better known as Stroke Acts GA Senate Bill 549 Coverdell-Murphy Act RI FL IL NJ House Bill 5798; Stroke Prevention and Treatment Act of 2009 Senate Bill 1590 Certified Stroke Center Law House Bill 2244 Primary Stroke Center Act Senate Bill 477 Stroke Center Act

13 Stroke Designation: States with non-legislative Administrative Policies or Rules related to Stroke Enacted Legislation Have supporting legislation Pending Legislation Administrative Policy or Rule WA OR NV CA ID AZ UT MT WY CO NM ND SD NE KS OK MN IA MO AR WI NY MI PA OH IL IN WV VA KY NC TN SC MS AL GA VT NH NJ DE MD ME CT RI MA TX LA FL AK HI 4 States that have not enacted legislation, instead have non-legislative administrative policies

14 Stroke Designation: States with Supporting Legislation for Cardiovascular disease & Stroke Enacted Legislation Have supporting legislation Pending legislation WA OR NV CA ID AZ UT MT WY CO NM ND SD NE KS OK MN IA MO AR WI NY MI PA OH IL IN WV VA KY NC TN SC MS AL GA VT NH NJ DE MD ME CT RI MA TX LA FL AK HI 16 States have supporting legislation but not directly mandating stroke designation & triaging

15 Statewide Stroke Certification

16 Stroke Certification: How to get certified? The Joint Commission (TJC) State Certification Det Norske Veritas (DNV) Hospital Facilities Accreditation Program (HFAP)

17 States with TJC certified Primary Stroke centers No TJC Certified Stroke Centers States have TJC Certified Stroke Centers WA OR NV CA ID AZ UT MT WY CO NM ND SD NE KS OK MN IA MO AR WI NY MI PA OH IL IN WV VA KY NC TN SC MS AL GA VT NH NJ DE MD ME CT RI MA TX LA FL AK Source: JCAHO ( ; Last accessed: November 1 st, 2014 HI TJC 1049 certified primary stroke centers in all states except MA

18 States with TJC certified Comprehensive Stroke Centers No TJC Certified Stroke Centers States have TJC Certified Stroke Centers WA OR NV CA ID AZ UT MT WY CO NM ND SD NE KS OK MN IA MO AR WI NY MI PA OH IL IN WV VA KY NC TN SC MS AL GA VT NH NJ DE MD ME CT RI MA TX LA FL AK Source: JCAHO ( ; Last accessed: November 1 st, 2014 HI TJC has 78 certified comprehensive stroke centers in 28 states

19 States with DNV certified Primary Stroke Centers No DNV Certified Stroke Centers States have DNV Certified Stroke Centers WA OR NV CA ID AZ UT MT WY CO NM ND SD NE KS OK MN IA MO AR WI NY MI PA OH IL IN WV VA KY NC TN SC MS AL GA VT NH NJ DE MD ME CT RI MA TX LA FL AK Source: DNV ( Last accessed: November 1 st, 2014 HI DNV has 87 certified primary stroke centers in 23 states

20 States with DNV certified Comprehensive Stroke Centers No DNV Certified Stroke Centers States have DNV Certified Stroke Centers WA OR NV CA ID AZ UT MT WY CO NM ND SD NE KS OK MN IA MO AR WI NY MI PA OH IL IN WV VA KY NC TN SC MS AL GA VT NH NJ DE MD ME CT RI MA TX LA FL AK Source: DNV ( Last accessed: November 1 st, 2014 HI DNV has 14 certified comprehensive stroke centers in 5 states

21 States with HFAP certified Primary Stroke Centers No HFAP Certified Stroke Centers States have HFAP Certified Stroke Centers WA OR NV CA ID AZ UT MT WY CO NM ND SD NE KS OK MN IA MO AR WI NY MI PA OH IL IN WV VA KY NC TN SC MS AL GA VT NH NJ DE MD ME CT RI MA TX LA FL AK Source: HFAP ( Last accessed: November 1 st, 2014 HI HFAP has 40 certified primary stroke centers in 12 states

22 States with HFAP certified Comprehensive Stroke Centers No HFAP Certified Stroke Centers State has HFAP Certified Stroke Center WA OR NV CA ID AZ UT MT WY CO NM ND SD NE KS OK MN IA MO AR WI NY MI PA OH IL IN WV VA KY NC TN SC MS AL GA VT NH NJ DE MD ME CT RI MA TX LA FL AK Source: HFAP ( Last accessed: November 1 st, 2014 HI HFAP has 1 certified comprehensive stroke center in 1 state

23 States with Self-Certification for Primary Stroke Centers No State Certified Primary Stroke Centers State Certification for Primary Stroke Centers WA OR NV CA AK ID AZ UT MT WY CO NM ND SD NE KS OK TX MN WI NY MI IA PA OH IL IN WV MO VA KY NC TN AR SC MS AL GA LA FL VT NH CT RI NJ DE MD ME MA 211 state certified primary stroke centers in 4 states (MA, NY, NJ, FL) HI Source: State Department of Public Health websites MA: NJ: NY: FL: Last accessed: November 1 st, 2014

24 States with Self-Certification for Stroke: Massachusetts

25 States with Self-Certification for Comprehensive Stroke Centers No State Certified Comprehensive Stroke Centers State Certification for Comprehensive Stroke Centers WA OR NV CA ID AZ UT MT WY CO NM ND SD NE KS OK MN IA MO AR WI NY MI PA OH IL IN WV VA KY NC TN SC MS AL GA VT NH NJ DE MD ME CT RI MA TX LA FL AK Source: State Department of Public Health websites NJ: FL: Last accessed: November 1 st, 2014 HI 43 state certified comprehensive stroke centers in 2 states

26 States with Self-Certification for Stroke: Florida

27 Brain attacks: Lessons learned from heart attacks

28 Stroke Center Certification mirrors Cardiac Centers Non-PCI capable Hospital: IV Fibrinolysis Primary Stroke Center: IV r-tpa PCI Capable Hospital: Balloon Angioplasty & Stenting Comprehensive Stroke Center: Clot Retrieval

29 Workforce Trends: Neuro-Intervention vs. Interventional Cardiology Interventional Cardiology Overall Annual Addressable Market Coverage 4 4 Neuro-Intervention Overall Annual Addressable Market in US* 1. Major Heart Attacks (STEMI s): ~ 275,000 (Approx. 30% of all 915,000 myocardial infarctions) 2. Major Brain Attacks (LVO s - Large Vessel Occlusions): ~318,159 (Approx. 46% of all 691,650 ischemic Number of trained Interventionalists strokes)** * Sources: Heart Disease and Stroke Statistics 2014 Update, American Heart Association ** STOP-stroke study, Stroke 2009; 40(12):

30 This is a team sport! Neurosurgery Neuro Intervention Neurology Radiology Administration

31 TSI Clinical Team TSI Stroke Intervention Physicians TSI Physician Services Vallabh Janardhan, MD Director, TSI Parita Bhuva, MD Ryan Gianatasio, MD Paul A. Hansen, MD Josh Canfield TSI Practice Manager TSI Stroke & Neuro-critical Care Physicians (Stroke Intervention In training) TSI Research Fellow Alex Venizelos, MD Keyur Patel, MD Suman Nalluri, MD MPH Chandril Chugh, MD Tanzila Shams, MD MHA

32 TSI Administrative Team Vallabh Janardhan, MD Director, TSI Mark Whitley Sr. VP Bus. Dev. Kathy Sheets, VP Physician Recruitment Anita Guthmann Director, Comprehensive Stroke Helen Hare Program Coordinator Beth Tuma VP Sales Tammy Stilling Neuroscience Business Development Scott Manis VP, Rural Outreach Will Smitham VP, HCAPS Joshua Hunter Director, Physician Recruitment

33 First in US geographically placed multi-hub & spoke Regional stroke network: Texas Stroke Institute Level Level 32 OUMC Level Level 32 Level 21 Level 2 Level 2 Level 1 Level 2 Level 1 Level Level 32 Level 2 Level Level 32 Level 2 Level 1 Level 1=Comprehensive Stroke Center; Level 2=Primary Stroke Center; Level 3=Stroke Support Facility

34 Q&A

RUSSIA OR CA WA AK NV CANADA ID UT AZ MT WY CO NM MEXICO HI ND SD NE KS TX MN OK CANADA IA WI LA IL MI IN OH WV VA FL ME VT NH MA NY CT NJ PA MO KY NC TN SC AR AL GA MS MD BAHAMAS CUBA RI DE 3 RUSSIA 1

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