1. Childhood Immunization How Far Weve Come And How Far We Have to Go Alan R. Hinman, MD, MPH Indiana Immunization Conference October 16-17, 2007

2. Outline of presentation Current status of childhood immunization in the US How immunizations are financed in the US Inequities in financing –Causes –Possible solutions Further issues with adult immunization

3. Diphtheria 175,885 0 100 Measles 503,282 66 >99 Mumps 152,209 314 >99 Pertussis 147,271 25,616 83 Polio (paralytic) 16,316 1** 100 Rubella 47,745 11 >99 CRS 823 1 >99 Tetanus 1,314 27 98 Hib/unk (<5 yrs) 20,000+ 226 99 Disease Pre-vaccine Era* 2005 % change *Typically, average during 3 years before vaccine licensure **Imported, vaccine-associated poliovirus + Estimated because no national reporting existed in the prevaccine era Comparison of 20 th Century Typical and Current Reported Morbidity, Vaccine-Preventable Diseases

4. U.S. Haemophilus influenzae Type b Cases - 1985-2001* *2001 data provisional

5. Impact of PCV7 Vaccine on Racial Disparities in Invasive Strep pneumoniae Infection Flannery et al. JAMA 2004; 291: 2197 - 2203

6. Herd Effect in Adults 65+ Years PCV7 types v. 16 types only in PPV ABCs 1998/99 average vs. 2003 SerotypeCases/100,000 popPercent change 95% CI Baseline2003 Vaccine3412-65-69, -59 Nonvaccine2730+13+1, +25 16 types only in PPV* 1719+17+2, +33 *PPV= 23 valent pneumococcal polysaccharide vaccine

7. 0.00 2.00 4.00 6.00 8.00 10.00 12.00 14.00 199419951996199719981999200020012002 Year Rate (per 100,000 population) <10 yrs 10-19 yrs 20-49 yrs 0-49 yrs *Varicella as the primary diagnosis code Varicella-related Hospitalization Rates*, 1994-2002 Zhou F, et al. JAMA 2005

8. Hepatitis A Incidence by County, 1987-97 and 2005 Rate per 100,000 0-4 5-9 10-19 20+ 1987-1997 2005

9. Incidence of hepatitis A per 100,000 population, by vaccination recommendation status, 1966-2006* Vaccination recommended in high-risk groups Vaccination recommended in high-risk areas Source: NNDSS * 2006 data provisional

10. Number of Vaccines in the Routine Childhood and Adolescent Immunization Schedule 198519952006 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 Hib (infant) HepB Varicella Measles Rubella Mumps Diphtheria Tetanus Pertussis Polio 7 10 16

12. Increasing Vaccine-Specific Coverage Rates Among Preschool-Aged Children DTP(3+) is not a Healthy People 2010 objective. DTP(4) is used to assess Healthy People 2010 objectives. Note: Children in the USIS and NHIS were 24-35 months of age. Children in the NIS were 19-35 months of age. Source: USIS (1967-1985), NHIS (1991-1993) CDC, NCHS, and NIS (1994-December 2003), CDC, NIP and NCHS; No data from 1986-1990 due to cancellation of USIS because of budget reductions. DTP(3+) MMR(1+) Hib (3+) 2010 Target Hep B (3+) Polio (3+) Varicella (1+) PCV 7 (3+) 2005

13. Vaccination coverage among children 19-35 months of age, 2006 VaccineUSA IN DTP/DTaP 4+85.2%84.5% Polio3+92.9%92.4% MMR1+92.4%89.5% Hib3+93.4%90.7% Hep B3+93.4%92.1% Varicella1+89.3%88.0% PCV3+87.0%87.3%

14. Vaccination coverage among children 19-35 months of age, 2006 Series USAIN 4+ DTP/3+ Po/1+ MCV 83.2%82.6% 4/3/1/3+ Hib 82.3%80.8% 4/3/1/3/3+ Hep B 80.6%79.5% 4/3/1/3/3/1+ Varicella 77.0%75.9%

15. Estimated Vaccination Coverage Among Children Enrolled in Kindergarten - United States, 2006-2007 School Year >3 Polio96.3% >4 DTP96.0% >1 MMR95.6% >3 Hep B96.8% >1 Var 96.5% or history of varicella disease CDC, MMWR 2007; 56:819-821

16. Eliminating Racial Disparity in Immunization Coverage 4:3:1:3:3:1 Estimated Vaccination Coverage by Race/Ethnicity, 19-35 Month Old Children, US National Immunization Survey, MMWR Sept 14, 2006

17. Immunization Coverage Rates of 19-35 month old Children in the United States, 2006 VaccineTotalWhiteBlackHispanic 4+ DTP85.2%86.6%81.4%84.7% 3+ polio92.9%93.3%90.7%93.4% 1+ MMR92.4%92.8%91.0%92.1% 3+ Hib93.4%94.0%91.1%94.0% 3+ Hep B93.4%93.9%91.5%93.6% 1+ Var89.3%88.8%89.2%89.8% 4+ PCV68.4%70.8%61.1%67.5% 4:3:1:3:3:177.0%77.9%73.9%77.4% CDC. MMWR 2007;56:881-885

18. Estimated vaccination coverage among adolescents 13-17, US 2006 MMR 2+ 86.9% Hep B 3+81.3% Varicella*89.6% Td/Tdap**60.1% MCV11.7% *Vaccine or disease **Since age 10 years

19. Types of costs in immunization Vaccine purchase Vaccine administration Non-vaccine costs

20. Federal Contract Prices for Vaccines Recommended Universally for Children and Adolescents 1985, 1995, 2006 Federal contract price shown for 1985 and 1995 are averages that account for price changes within that year. $45 $155 $1182

21. Sources of financing childhood immunizations Government –Federal –State/local Insurance –Private –Public Out-of-pocket

22. 317 Immunization Program 317 grants support: Purchase of vaccine for free administration at local health departments Immunization delivery Surveillance Communication Education

23. Percent Increase of the Cost of Full Series vs. Percent Increase of Section 317 Appropriation 2005 estimate includes one dose of MCV4 and one dose of Tdap in adolescents.

24. Childhood Vaccine Doses Distributed by Funding Source Calendar Year 2005 Source: Vaccine manufacturers Biologics Surveillance Data 2005 Note: Does not include influenza vaccine

25. How Public Health Reaches Children through VFC VFC program has 45,000 provider sites –75% of sites are private providers –25% are public sector sites Collectively, VFC providers vaccinate 90% of children –VFC vaccine for VFC-eligible children –Private purchase vaccine for other children Improving VFC providers practices improves vaccinations for almost all children

26. Contrasts Between 317 and VFC Funding Sources Attributes317VFC Source Discretionary annual appropriation Mandatory EligibilityNot restricted Medicaid-enrolled; Uninsured; Native American, Alaska Native; Underinsured* Stability Significant fluctuations possible Stable funding stream * Underinsured only at Federally Qualified Health Centers and Rural Health Clinics

27. VFC and Section 317 Vaccine Funding to Immunization Programs

28. Two-Tiered State Vaccination Policies at Local Health Departments Traditionally, health department clinics vaccinated any child brought for vaccination Underinsured children ineligible for VFC vaccine except at FQHCs and RHCs (~3,000 clinics) –VFC designated FQHCs and RHCs as safety-net providers for underinsured children –State and 317 funding used for underinsured –Due to inadequate state/317 funding, many states cannot purchase vaccine for underinsured children Result is a two-tiered policy –Government purchased vaccine not available to underinsured at health department clinics –Access to new vaccines for some based on insurance –Ethical tension for public health officials and providers

29. Two-Tiered States: 2005 Invasive pneumococcal disease –13 states did not purchase PCV7 vaccine for underinsured children in health department clinics Invasive meningococcal disease –31 states did not purchase MCV4 vaccine for underinsured children in health department clinics These states do not have a public health department safety net to vaccinate children against these diseases

30. Grantees Provision of Vaccines to Underinsured Children, 2006 (N=49) Source: Grace Lee et al; Harvard University

31. Private insurance for childhood immunizations Approximately 53% of children <5 in 2003 Approximately 10% considered uninsured Most insurers cover ACIP vaccines within approximately 3 months Many require provider to purchase vaccine – up-front costs for inventory Reimbursement may take some time and may not cover true cost of purchase

32. Public insurance for childhood immunizations Medicare Medicaid CHIP –Medicaid enhancement –S-CHIP

33. Out-of-pocket expenses for childhood immunizations Primarily with underinsured children Providers may refer to health departments Exacerbated by costs of newer vaccines May be further exacerbated by efforts to make HPV mandatory without assuring that all children have access to vaccine in public sector

34. Inequities in vaccine purchase - causes Underinsurance Inability of 317 and state/local funds to keep up with increasing vaccine costs Burden on private providers to make large advance investments in purchasing new vaccines Ethical dilemma at both state and provider levels

35. Inequities in vaccine purchase – some possible solutions Increase 317 appropriations Expand access to VFC for underinsured Allow access to VFC for S-CHIP Assure providers are fully reimbursed for purchase costs Allow delayed payments to vaccine manufacturers/distributors

36. Vaccine administration Studies indicate that it costs approximately $18-25/injection to administer vaccines VFC does not reimburse for vaccine administration Widely varying rates of reimbursement from Medicaid and private insurers

38. Inequities in vaccine administration reimbursement Some possible solutions –Reimbursement from VFC –Minimum/recommended reimbursement rate from CMS –Negotiation with private insurers

39. Non-vaccine costs Include costs of –Acquiring vaccine –Storing vaccine –Handling vaccine –Loss of vaccines –Infrastructure –Insurance

40. Inequities in non-vaccine costs - causes 317 can support HD costs VFC supports infrastructure and program costs; administration fees, in theory, include non-vaccine costs –However, Medicaid establishes reimbursement rate Private insurers typically do not include non-vaccine costs in calculating reimbursement rates

41. Inequities in non-vaccine costs – some possible solutions CMS establishes minimum or recommended reimbursement rate Private insurers encouraged to include non-vaccine costs in reimbursement calculations

42. What is being done AAP Task Force on Immunization NVAC Financing Work Group IDSA workgroup on adult and adolescent immunization AMA/AAP/IDSA National Immunization Congress

43. Recommendations from Immunization Congress - 1 Work with FQHCs to delegate authority to public health clinics to serve underinsured through VFC Obtain data on cost of delivering vaccines in private practice setting and use data to educate payers and advocate for better payment Work with manufacturers/distributors to obtain more favorable terms for payments for vaccine inventories

44. Recommendations from Immunization Congress - 2 Better define components of CPT codes for immunization administration Examine potential role of tax credits for insurers or employers in eliminating underinsurance Create working group to explore possibility of federal vaccine purchase or funding mechanism

45. Recommendations from Immunization Congress - 3 Obtain from CMS the data that led to current Medicare administration fee and use data to advocate at state level for enhanced payment Collect data on true cost of obtaining/delivering combination vaccines as opposed to individual vaccines Disseminate information on best business practices to minimize vaccine and administration costs

46. Increasing Vaccine-Specific Coverage Rates Among Preschool-Aged Children DTP(3+) is not a Healthy People 2010 objective. DTP(4) is used to assess Healthy People 2010 objectives. Note: Children in the USIS and NHIS were 24-35 months of age. Children in the NIS were 19-35 months of age. Source: USIS (1967-1985), NHIS (1991-1993) CDC, NCHS, and NIS (1994-December 2003), CDC, NIP and NCHS; No data from 1986-1990 due to cancellation of USIS because of budget reductions. DTP(3+) MMR(1+) Hib (3+) 2010 Target Hep B (3+) Polio (3+) Varicella (1+) PCV 7 (3+) 2005

47. Pneumococcal vaccination coverage among adults 65 years and older, 1989-2006 Note: NHIS data through 2005; percent receiving vaccine in 2006 is January-June interviews only. Source: National Health Interview Survey (NHIS), CDC, NCHS. 2010 Target Percent

48. Influenza vaccination coverage during the previous 12 months, among adults 65 years and older, 1988/89-2005/06 Note: Percent receiving vaccine is estimated per Influenza season, using the January-June interviews only. Source: National Health Interview Survey (NHIS), CDC, NCHS. *Coverage was statistically lower than during the previous season, p<0.05 2010 Target Percent *

49. Influenza vaccination coverage during the previous 12 months among adults 65 years and older, by race/ethnicity, 1988/89-2004/05 2010 Target *Can be of any race. Note: Percent receiving vaccine is estimated per influenza season, using the January-June interviews only. Source: National Health Interview Survey (NHIS), CDC, NCHS. White, Not Hispanic Hispanic* Black, Not Hispanic Percent

50. Differentiating characteristics of childhood and adult immunization Delivery system infrastructure Financing mechanisms Highly effective vaccines preventing recognizable diseases Patient/parent/societal expectations Provider attitudes Leadership of state/local health departments and CDC

51. Delivery system infrastructure Both children and adults receive most immunizations in private sector Health departments a safety net for children, not so much for adults VFC provides strong ties between health departments and private providers; nothing comparable for adults

52. Financing mechanisms Uninsured children have entitlement to free vaccine through Vaccines for Children (VFC); cost not really a barrier except to underinsured Adults >65 have entitlement through Medicare No comparable mechanism for the 16% of adults <65 who are uninsured – cost is a barrier 317 funds can be used for children and adults but children have gotten priority

53. Patient/parent/societal expectations School immunization requirements for children National vaccine injury compensation program for children Nothing comparable for adults

54. Provider attitudes Physician is the most trusted source of information about immunization Immunization/well visits a major part of clinical care for children; less so for clinical care of adults Pneumococcal and influenza vaccines not as effective as childhood vaccines; may be less perceived benefit to provider

55. Leadership of state/local health departments and CDC Childhood immunization program structure in each state health department; few states have adult immunization program structure National Immunization Survey for children; BRFSS for adults States respond to low coverage in children; not so much to low coverage in adults

56. NVAC 2005 recommendations Expanded funding through Section 317 to support adolescent and adult immunization programs Promotion of first-dollar insurance coverage Assurance of adequate reimbursement for administration of vaccines Expanded discussion about the need, desirability, and feasibility of a variety of approaches to ensure that adults have access to vaccines, even if they do not have insurance

57. Partnership for Prevention 2005 recommendations Purchase and distribute influenza vaccine for uninsured adults Ensure first-dollar coverage for influenza and pneumococcal vaccines in the Federal Employee Health Benefit Program Expand Section 317 of the Public Health Service Act to address adult immunization needs Launch a national campaign to educate Americans about the value of adult immunizations

58. IDSA 2007 working principles Increase demand Strengthen capacity to deliver Expand provision of vaccines in insurance Promote immunization as a measure of health care quality Monitor and improve performance of the vaccine delivery and safety monitoring systems Assure adequate support for research

59. What are the minimum actions we should take? Increase 317 appropriations with an earmark for adult immunizations Establish an infrastructure for promoting/coordinating adult immunizations Ensure adequate reimbursement for vaccine administration Establish a culture of immunization in those who provide care to adults

60. Conclusions Private-public partnership has improved childhood immunization rates –Increasing 317 appropriations –Implementation of VFC Increasing number and costs of vaccines have put strains on system resulting in inequities Unless resolved, these inequities may undermine our current successes Dealing with adolescents and adults adds complexity