Vaccine Services Update

1. Vaccine Services Update Karen Hess Vaccine Services Manager February 19, 2009

2. Topics Providers NIS Vaccine Update Electronic Vaccine Accounting Non-Compliance Policy

4. 2007 Co-CASA Rates

5. Public vs. Private RecruitmentDoses Administered Percentage

6. 2007 NIS Texas vs. National

7. 2007 NIS PCV7 Results: Texas vs. National

8. TVFC Site Visits by Year

9. Vaccines Shipped by Year

10. Vaccines Shipped 2006-2008

12. Number of Vaccines in the Routine Childhood and Adolescent Immunization Schedule 1985 1995 2008 Measles Rubella Mumps Diphtheria Tetanus Pertussis Polio Hib (infant) HepB Varicella Measles Rubella Mumps Diphtheria Tetanus Pertussis Polio Hib (infant) HepB Varicella Pneumococcal disease Influenza Meningococcal disease HepA Rotavirus HPV Measles Rubella Mumps Diphtheria Tetanus Pertussis Polio 7 10 16

13. DTaP Hepatitis B Hepatitis A Hib Human Papillomavirus Influenza Polio Varicella MMR Meningococcal Pneumococcal Conjugate Combination Vaccines DTaP/Hepatitis B/Polio DTaP/Polio/Hib Hepatitis B/Hib MMR/Varicella Vaccines Currently Availablethrough the TVFC Program • Rotavirus • Td • Tdap

14. Last Three Years In Vaccine Releases • 3 Newly Licensed Vaccines in 2006 • Gardasil®,Zostavax®, RotaTeq® • 2 Newly Licensed Vaccines in 2007 • Menactra™ (2-10 years) • FluMist® (5-49 years) • 4 Newly Licensed Vaccines in 2008 • Kinrix®, Pentacel®, Rotarix®, BOOSTRIX® (for 19-65 year olds), FluMist® (2-49 years) As of 1/20/2009

15. New Vaccines

16. PedvaxHib® Shortage • Improvement in the supply is not expected until summer 2009 • The booster dose of Hib vaccine usually administered at 12-15 months of age should be deferred except for children at increased risk of Hib disease • asplenia • sickle cell disease • immunodeficiency (including HIV infection and cancer) • American Indian children • Alaska Native children Note: DSHS distributes the 3 dose ActHib® product only.

17. Hib TVFC Maximum Stock Levels and Pentacel® • Currently providers are limited to a 60-Day supply of Hib based on previous usage • Pentacel® (DTaP-IPV/Hib) counts as part of that 60-day allocation A dose of Pentacel = A dose of Hib

18. Hib Shortage Hib Hepatitis B/Hib DTaP/Polio/Hib Hep B Shortage Hepatitis B/Hib DTaP/Hepatitis B/Polio January 2009, Merck experienced a supply interruption in the U.S. for the adult formulation of their hepatitis B vaccine, Recombivax HB®. Pediatric Shortage possible Recombivax HB® Shortage

19. Electronic Vaccine Accounting (EVA) • CDC New Vaccine Ordering System • New reporting elements • On-line ordering and reporting for all TVFC providers. • Vaccine Choice Legislation • Increase Brand Options • Add presentation (syringes, vials) • Simplify ordering • Create “recommended order” • Auto mathematical calculation features • Pre-population of previously entered inventory information (lot number, NDC, expiration date) • Automated reminder

20. EC-33 Monthly Biological Report Legend: Yellow – provider completes Green – pre-populated on the form Blue – mathematical summation

21. EC-33 Monthly Biological Report Legend: Yellow – provider completes Green – pre-populated on the form Blue – mathematical summation

22. Biological Order Form

23. EVA - Next Steps • Request capital authority • Contract out for bid • Workgroup formed • Focus group and pilot testing • Goal by September 2010

24. Provider Compliance Policy • CDC Focus on Quality • Certified Thermometers • Refrigeration/Freezer Units • Fraud and Abuse • Inventory control

25. Hierarchy of VFC Provider Education Primary-Routine, orientation, updates Secondary- Moderate compliance issues- Tertiary- Serious compliance issues immediate & Significant actions must occur to correct situation 3 Research must occur through out all steps of algorithm and is defined as contacting other internal or external agencies that may include but not limited to legal counsel, Medicaid, licensing board or excluded provider list

26. Provider Compliance Policy Purpose • Consistent process when handling TVFC compliance issues • Identify high risk non-compliance issues • Protect TVFC from potential fraud and abuse • Prevents re-occurrence with sufficient training, education, and documentation • Identifies need to refer providers to the Texas State Office of Inspector General (OIG), or terminate from the TVFC program

27. Non-Compliance Flow Chart Initial Problem Identification SECONDARY EDUCATION Problem Resolved Extenuating Circumstances FORMAL INTERVENTION TERTIARY EDUCATION REFERRAL TO OIG TERMINATION FROM TVFC

28. Provider Compliance Policy Format • Policy • Definitions • Procedures • Non-Compliance Identified During a On-Site Visit • Non-Compliance Identified by Other Means

29. 10 High Risk Questions • 12. Vaccines provided regardless of inability to pay • 14. Administration fee is less than or equal to the maximum fee • 48a. Appropriate refrigerators/freezers are used to store vaccine • 50a. Refrigerator/freezer temperature log is available for the last three months • 50d.From the logs provided, all recorded refrigerator temperatures are within the recommended range. • 51c. From the logs provided, all recorded freezer temperatures are within the recommended range. • 55. A physical inventory of vaccine is done monthly • 57. The loss/gain is less than 5% • 59. TVFC vaccines can be distinguished from private stock • 61a. All clients are screened for eligibility

30. High Risk Questions“Yes” “No” Percentage

31. Compliance Policy Feedback • Operations Manual Appendix • Gauge Success • CDC and HSR/LHD feedback

32. Thank You