Findings from case studies of state and local immunization programs

Findings from Case Studies of State and Local Immunization Programs Gerry Fairbrother, PhD, Hanns Kuttner, MA, Wilhelmine Miller, MS, PhD, Roy Hogan, MPA, Heather McPhillips, MD, MPH, Kay A. Johnson, EdM, MPH, E. Russell Alexander, MD Background: As part of its examination of federal support for immunization services during the past decade, the Institute of Medicine (IOM) Committee on Immunization Finance Policies and Practices (IFPP) commissioned eight case studies of the states of Alabama, Maine, Michigan, New Jersey, North Carolina, Texas, and Washington; and a two-county study of Los Angeles and San Diego in California. Specifically, the IOM Committee and these studies reviewed the use of Section 317 grants by the states. Section 317 is a discretionary grant program that supports vaccine purchase and other immunization-related program activities. These studies afforded the Committee an in-depth look at local policy choices, the performance of immunization programs, and federal and state spending for immunization during the past decade. Methods:

The case-study reports were developed through interviews with state and local health department officials, including immunization program directors, Medicaid agency staff, budget analysts, and Centers for Disease Control and Prevention public health advisors to the jurisdiction. Other sources included state and federal administrative records and secondary sources on background factors and state-level trends. The case studies were supplemented by site visits to Detroit, Houston, Los Angeles, Newark, and San Diego.

Observations: The nature of immunization “infrastructure” supported by the Section 317 program is shifting from primarily service delivery to a broader set of roles that puts the public effort at the head of a broad immunization partnership among public health, health financing, and other entities in both the public and private sectors. The rate and intensity of transition vary across the case-study areas. In the emerging pattern, service delivery increasingly takes place in the private sector and is related to managed care. “Infrastructure” is moving beyond supporting a core state staff and local health department service delivery to include such activities as immunization registries, quality improvement, and coordination with programs outside public health agencies. At the same time, the recent decline in federal Section 317 support is forcing difficult choices between old and new activities at the state and local levels. Conclusions: Immunization programs function as an organic component of the local health care financing and delivery systems of which they are a part. Immunization efforts are organized and conducted within distinctive state and local fiscal, economic, and health care contexts. Section 317 Financial Assistance grants, while playing a vital role in supporting immunization “infrastructure,” have been too unstable and unpredictable to elicit the strategic planning, programming, and own-source spending that would be optimal for state and local programs. The predominant immunization function of state and local public health agencies is becoming assurance of age-appropriate immunization throughout the lifespan. To be successful in this emerging role, the health agencies must be supported with appropriate staffing, interagency collaboration, and clearly articulated authority. Medical Subject Headings: case studies, health planning, immunization programs, registries, vaccines (Am J Prev Med 2000;19(3S):54 –77) © 2000 American Journal of Preventive Medicine

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Introduction

N

ational and local immunization policies and programs exemplify the complex and multiform relationships that have developed over time between public health activities and the U.S. health care financing and delivery systems. Immunization strategies also reflect the changes underway in health care delivery. We report on this complexity and change as detailed in case studies of immunization programs and activities in nine jurisdictions: Alabama, two California counties (Los Angeles and San Diego), Maine, Michigan, New Jersey, North Carolina, Texas, and Washington State. The Institute of Medicine (IOM) Committee on Immunization Finance Policies and Practices (IFPP) commissioned eight case studies to gain an understanding of how the Section 317 funds provided by the federal government are incorporated into immunization programs by states.1–9 A few comparisons among the case-study areas remind us both of the country’s diversity and of common themes in the national immunization partnership. Los Angeles county’s population is larger than that of five of the seven states studied. Its birth cohort is ten times that of the smallest state we examined (Table 1). The strategies adopted by individual states to achieve immunization coverage of their populations vary. The few generalizations about the transformations within state and local immunization programs over the course of the 1990s that are warranted are summarized below. ● ●

●

The public sector is delivering a decreasing share of immunizations. “Medical homes” are becoming more important as the site of delivery than free-standing immunization services. The success of the immunization effort is dependent on larger forces than those wielded by state immunization programs. The most important of these is the ability of managed care, and, in particular, Medicaid managed care, to ensure timely immunization.

Immunization Coverage Rates The national immunization coverage rate is the sum of what happens in the states and their communities. The trend in outcomes from 1995 to 1998 has shown improvement. The best indicator of how well the

From the Department of Epidemiology and Social Medicine, Albert Einstein College of Medicine/Montefiore Medical Center (Fairbrother), New York, New York; School of Public Health, University of Michigan (Kuttner), Ann Arbor, Michigan; Institute of Medicine, National Academies (Miller), Washington, DC; Roy Hogan Consulting (Hogan), Austin, Texas; Johnson Group Consulting, Inc., (Johnson), Hinesburg, Vermont; and School of Public Health (McPhillips), University of Washington (Alexander), Seattle, Washington Address correspondence and reprint requests to: Wilhelmine Miller, Institute of Medicine, 2101 Constitution Avenue, NW, FO 3101, Washington, DC 20418. E-mail: [email protected].

immunization system functions is the National Immunization Survey (NIS), which reports national-, state-, and urban-area immunization coverage levels among children aged 19 months to 35 months.13,14 State-level results for the 4:3:1:3 immunization series reveal substantial variability around the national rate of 79%, from 71% in Arkansas and 73% in Texas, Idaho, and Oregon, to 88% or 89% in Connecticut, Massachusetts, Rhode Island, and Vermont (Figure 1). Each state’s rates reflect the challenge posed by its populations and how well the state responds to this challenge given its available resources. The variables in Table 1 provide a sense of that challenge and states’ responses and allow consideration of what “risk-adjusted” rates might be. For example, among the case-study areas, Maine has the best results, but its demographics suggest that its challenge is less than that facing Texas. Texas has the poorest measured results but the secondhighest share of children aged ⬍5 years in poor households and the highest share of children without health insurance among the case-study areas.

State-Level Program Organization Juxtaposed against these population factors is the state immunization program. In each state and county considered, some organization is responsible solely for immunization. Called variously a program, division, or service, its head is two to four levels removed from the governor or county chief executive. This state immunization program is responsible for administering and accounting to the Centers for Disease Control and Prevention (CDC) for vaccines and funding awarded to the states through Section 317 Financial Assistance (FA) and Direct Assistance (DA) grants. Section 317 FA grants can be used by states to operate and support state and local immunization-related activities. Section 317 DA is federal assistance “in kind”—the vast majority of DA is in the form of a line of credit to acquire vaccines under federal purchase contracts with manufacturers. A relatively small fraction of DA (⬍4% in 1999) to the 64 state, municipal, and territorial grantees is in the form of federal personnel and personnel-support costs.

Methods The eight cases studies were commissioned by the IOM Committee on IFPP. The Committee chose this approach to gain a deeper understanding of state and local policy choices and performance to inform its deliberations about the level and structure of federal support for immunization services. In particular, the impact of fluctuations on the overall level of Section 317 FA during the past decade, and of the federal Vaccines for Children (VFC) program on state policy choices and program funding were the focus of these studies. The case-study sites were selected to reflect diversity among the states and localities with respect to size, population density, economic wealth, the extent of the role of public

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Table 1. Demographic characteristics State population growth, 1990–1999, relative to Total state Birth population national (in millions), population cohort growtha 1990b 1999a

State Maine New Jersey N. Carolina Alabama Michigan Texas Washington California Los Angeles San Diego National

1.253 8.143 7.651 4.37 9.864 20.044 5.756 33.145 9.33 2.821 272.69

.21 .53 1.6 .85 .64 1.87 1.91 1.16 .55 1.34

17,359 122,289 104,525 63,487 153,700 316,423 79,251 612,628 208,623 51,809

Birth cohort 1997b 13,669 113,279 107,015 60,914 133,714 333,974 78,190 524,840 164,298 43,889

% Population living in State MSA birth rate (state relative to % % national Nonwhite share/ Children birth rate, births,b national share) uninsuredc 1997 1997 .94 .97 .99 .97 .94 1.19 .96 1.12 1.22 1.07

1 (⫹9.6%) 4,158,212 3,880,894

7 42 35 35 30 59 28 66

40

36 (.45) 100 (1.25) 67 (.84) 68 (.85) 82 (1.03) 84 (1.05) 83 (1.91) 97 (1.21)

80

% Children under age 5 <100% FPL, 1996d

Fiscal capacity index (national rank)e

13 14 15 15 8 24 9 18

21 14 22 30 21 30 19 28

111 186 92 68 88 62 114 73

14

23

100

a

Bureau of the Census, Current Population Survey (CPS) data. b National Center for Health Statistics (NCHS).10 c CPS, 1994 –1998 average, cited in Annie E. Casey Foundation.11 d Bureau of the Census, March 1997 Supplement to the CPS. e Fiscal capacity index developed by Douglas and Flores.12 MSA, metropolitan statistical area; FPL, federal poverty limit

vaccine purchase and immunization programs, and the extent of public and private health insurance coverage. With this small sample of seven states and two counties in California, we make no claims that the program models we have selected are nationally representative. Nevertheless, we have

tried to provide a sense of the variety of conditions and approaches to immunizing a population that exist across the United States. The case-study reports were developed through interviews with state health department officials, including immuniza-

Figure 1. Immunization coverage levels for U.S. states, 1998 (4:3:1:3 Series [4 DTP, 3 polio, 1 MMR, and 3 Hib]). Source: Centers for Disease Control and Prevention, 1998 National Immunization Survey

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Figure 2. National Section 317 Financial Assistance funding, 1990 –1999 tion program directors, Medicaid agency staff, budget analysts, and CDC public health advisors. In visits to Detroit, Houston, Newark, and Los Angeles and San Diego, site visit teams composed of IFPP Committee members, staff, and case-study authors met with local public health officials and their immunization partners—physicians and administrators at safety-net providers, researchers at academic health centers, and physicians in private practice. These sites were selected because they are large municipalities with pockets of need in states for which we were collecting information and, in the case of Houston, a Section 317 grantee in its own right. Health departments were asked to provide information about expenditures of state- or local-source revenues for immunization program operations and vaccine purchases from each jurisdiction (the seven states and Los Angeles and San Diego counties). Until recently, reporting of this kind of functional expenditure information had not been federally required (the CDC now asks states to report their own-source expenditures for immunization activities in their annual Section 317 grant applications). The states reported spending for two inclusive categories—vaccine purchases and all other immunization-related activities. Annual state expenditures have been reported by the individual state health departments for their own fiscal year (FY) period. The expenditures for Section 317 and VFC, however, are as reported by the CDC for its program year, which is the calendar year (CY). Expenditures in 1999 for Section 317 and VFC are estimated at the level of the grant awards for 1999. Finally, to obtain information about program planning, past performance, and expenditures, we examined the eight states’ applications to the CDC for Section 317 funds for 1992, 1995, 1999, and 2000.

Program Spending and Vaccine Purchase in the 1990s In the early 1990s, Section 317 FA new grant awards to the states more than doubled from one year to the next on two occasions, from $37 million to $92 million (1991–1992), and from $98 million to $228 million (1993–1994), as the Bush and Clinton administrations in turn launched immunization initiatives (Figure 2). The high point of new Section 317 FA awards occurred in 1995 at $261 million nationally, while total awards to the states (including de-obligated amounts carried over and re-awarded by the CDC) grew to $371 million in 1996 before declining. New FA awards for each of the past 2 years were just $19 million more than in 1993. Overall, state expenditures of Section 317 FA funds increased substantially each year until 1996 when the states spent $248 million, plateaued briefly, and then decreased markedly in 1998 and again in 1999, with the reduction in new grants and the exhaustion of carryover awards (Figure 2). Each state studied showed this pattern of rapidly increasing and then decreasing grant awards, echoed by slower and lagged rates of growth and decline in expenditures. Figures 3 through 6 display this pattern of funding for California, Michigan, North Carolina, and Texas. A combination of factors—the incorporation of new vaccines and age groups into the immunization schedule, and the introduction of VFC on 1 October 1994 — Am J Prev Med 2000;19(3S)

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Figure 3. California Section 317 Financial Assistance funding, 1990 –1999

complicate any simple view of Section 317 DA during the past decade. In nominal dollars, new awards were somewhat reduced at the end of the decade ($128 million in 1999) than in 1990 ($149 million), while expenditures in these bracketing years were in the reverse relationship: $106 million in 1990, and an estimated $134 million in 1999. Nationally, expenditures reached a high in CY 1994 ($172 million), the last period before the first full year of operation of the VFC program, when Section 317 DA expenditures for the decade fell to a low of $96 million, before gradually increasing again. In our case studies, we focused primarily on the federal and state funding streams for vaccine purchase since late 1994 when VFC became operational.

State and Section 317 Support for Programs and Operation Every state has an immunization program that operates within an agency responsible for public and personal health programs and services. In some states, counties are extensions of state authorities, and local health department (LHD) personnel are state employees. In other states, counties have independent authority, tax bases, and personnel systems. The source of state financing for public health functions and providing immunizations is likewise variable. Some states structure arrangements consolidating federal- and staterevenue monies to counties and municipalities for 58

population-based activities or direct immunization delivery. In other states, counties and municipalities are responsible for financing most of their own activities. Michigan’s public health code commits the state to supporting 50% of county costs for eight public health functions, including immunization. These state– county contracts become a mechanism for channeling expanding Section 317 infrastructure awards from the state to LHDs. Alabama, California, North Carolina, Texas, and Washington annually appropriate and distribute funds for immunization activities to LHDs— counties, multicounty health districts, and large municipalities. LHDs, usually county agencies, may be more or less autonomous from their state counterparts. Alabama exemplifies very close policy and management control by the state; in contrast, North Carolina, atypical among southern states, has quite independent counties. Maine, the only small state studied, has only three local (city) health departments. The immunization program is operated by the state, which works directly with these three LHDs, ⬎50 participating clinic providers, and about 400 private-practice physicians in the state to deliver immunization services. New Jersey exemplifies the model of extremely limited state-level fiscal involvement in local public health service delivery; New Jersey LHDs receive two thirds of their support from local tax revenues. Table 2 presents population-adjusted spending levels by source of funds over the initial period of VFC

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Figure 4. Michigan Section 317 Financial Assistance funding, 1990 –1999

implementation. It displays 1995 and 1998 state (and in the cases of Los Angeles and San Diego, county) spending for immunization activities for each member of the birth cohort in the state (or county) for Section 317, VFC, and own-source revenues. We standardized spending for federal, state, and local immunization programs by the state birth cohort only for the purpose of cross-state comparisons. Other per capita calculations could be made using total state population or the number of poor children in the state. Virtually all state immunization program heads viewed stability and predictability of funding as essential for effective program planning and operation.15 This is not the picture of support Figures 2 through 6 display. The rapid increase of Section 317 FA awards in the early and mid-1990s in the aftermath of the measles outbreaks of 1989 –1991 allowed states to expand staffing and programs, and to make new financial commitments to LHDs. For example, between 1992 and 1995, LHD staffing in North Carolina more than doubled, as a result of both federal and state initiatives to provide more direct immunization services. Texas passed a law in 1993 mandating age-appropriate immunization of all children in the state. To implement this requirement, the state increased its own funding for immunization from $40 million for the 1992–1993 biennium to $72 million for the 1994 –1995 biennium. The ability to carry over Section 317 funds not

obligated in prior years allowed states to maintain program spending levels higher than newly awarded funds alone would have permitted through 1997 and, for some states, even through 1998. However, the continued reduction in Section 317 FA in 1999 and 2000 awards could not be buffered by funds carried over as states were increasingly able to spend their awards. North Carolina and Washington report that they are maintaining allocations of immunization program money (“aid-to-county” or “county contracts”) to LHDs in the face of 317 reductions by reserving less of their Section 317 FA awards for state agency use. In contrast, Texas reported that the state would allocate $900,000 less to LHDs in 1999 as a result of its reduced Section 317 award. While one possible response that the states might make to decreasing federal support for immunization infrastructure would be to increase their own spending, for the most part, our analysis shows that they have not (Table 2 and Figures 7 through 12). It is instructive to compare the states’ response to a previous reduction in health grants-in-aid. The first year of the Reagan administration (for FY 1982) saw dollar reductions in many grants-in-aid programs.16 States’ responses to lower Section 317 grants mirrored the response to the FY 1982 reductions. In that year, for each of three new public health block grants— one for alcohol, drug abuse, and mental health; another for maternal and Am J Prev Med 2000;19(3S)

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Figure 5. North Carolina Section 317 Financial Assistance funding, 1990 –1999

Figure 6. Texas Section 317 Financial Assistance funding, 1990 –1999

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Table 2. 317, Vaccines for Children (VFC), and state immunization spending per birth cohort member Vaccine purchase

State

317 DA, 1995

317 DA, 1998

VFC DA, 1995

VFC DA, 1998

Infrastructure State State 317 revenues, revenues, FA, 1995 1998 1995

317 FA, 1998

VFC FA, 1995

VFC FA, 1998

Maine

State State revenues, revenues, 1995 1998

$47.23 $137.76 $87.25 $116.47 Included Included $85.04 $121.81 $16.13 $34.28 $ 6.92 in infra. in infra. New Jersey 14.24 16.91 22.59 28.77 0.17 0.18 21.29 35.94 14.40 13.29 4.10 N. Carolina 19.57 29.47 40.71 102.04 77.65 100.33 56.84 38.69 3.29 3.50 16.16 Alabama 58.09 37.18 81.08 115.9 16.41 6.57 48.74 52.43 6.35 7.21 9.85 Michigan 36.13 78.25 65.72 95.29 28.33 0.76 46.19 46.37 17.77 10.73 4.69 Texas 20.17 27.24 87.27 103.37 61.86 41.11 26.72 41.69 3.01 6.20 50.61 Washington 32.47 41.77 40.15 76.84 45.68 90.57 58.43 41.32 3.68 11.13 4.55 California 13.31 17.61 97.78 138.24 44.64 34.89 2.30 3.76 Los Angeles 0.57 San Diego 1.11 National

$24.36 $ 34.93 $62.65 $103.06

$36.58 8.30 13.85 9.85 30.26 26.29 5.11 13.19 74.98

$49.42 $ 47.97 $ 5.89 $ 7.59

Sources: Centers for Disease Control and Prevention, National Immunization Program, program data for 317 and VFC; Institute of Medicine case study data for state and local immunization spending; and 1994 and 1997 birth cohorts, National Center for Health Statistics.10 Note: Los Angeles and San Diego include county as well as state spending.

child health; and a third for preventive health—the appropriation was about 25% less than the amounts their predecessor categorical programs received in FY 1981. Front-line programs felt no immediate impact in FY 1982, however, because states used carryover funds to continue programs at the same service level. As late as mid-1984, 2-1/2 years after the FY with “cuts” had begun, a field survey found that the full effects of the reductions had not yet been felt.16 What followed is relevant for the future of activities supported with Section 317 infrastructure funds. Maternal and child health programs, along with alcohol and drug programs, proved to have more allies at the state level than the services funded by the preventive health block grant. (The preventive services block grant replaced categorical programs for such purposes as rodent control and planning for emergency medical services.) States replaced funds lost because of lower

federal support for maternal and child health and substance abuse. At the local level, there were no “cuts.” By contrast, preventive services advocates were unable to build political support for increased funding and in only four of fourteen states sampled did states supplant federal support lost in the transition from categorical to block grants.16 Many states apparently see preventive health as primarily federal in character, and will not move to replace lost federal resources. Unlike most federal grant-in-aid programs, the CDC operates Section 317 (and VFC) on a CY program year. This produces a funding cycle substantially at odds with most states’ FYs, which typically run from July through June or, following the federal FY, from October through September. State legislatures generally act in the spring, and have been leery of appropriating state funds to interact with uncertain federal actions 6 months later.

Figure 7. Alabama infrastructure spending by source of funds, 1992–1999

Figure 8. Michigan infrastructure spending by source of funds, 1995–1999 (State spending for 1999 not available)

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Figure 9. New Jersey infrastructure spending by source of funds, 1992–1999

It may be too soon to definitively assess the state-level response to reductions in Section 317 FA, as states have been insulated from the full effects of reductions in grants by the amounts they carried over and spent in later years. Nonetheless, the previous cutbacks in federal support for preventive programs and subsequent outbreaks (such as the measles outbreaks of 1989 – 1991) provide cautionary lessons for federal and state policymakers.17

Vaccine Purchase States participate in the purchase and distribution of vaccines to varying degrees.15 Our study sites reflect the range of state involvement in vaccine purchase: three are universal purchase(UP) (Maine, North Carolina, and Washington), two have “enhanced VFC,” or partial state purchase for the uninsured (Michigan and Texas), and three distribute free vaccines only within public clinics and to federal program beneficiaries (Alabama, California, and New Jersey).

Figure 10. North Carolina infrastructure spending by source of funds, 1992–1999

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Figure 11. Texas infrastructure spending by source of funds, 1993–1999

The predominant structural change in vaccine financing during the 1990s was the implementation of the federal VFC program on 1 October 1994. The introduction of VFC had immediate and continuing dynamic effects on the relative shares of public vaccine purchases represented by state purchases and Section 317 DA. In most studied states, Section 317 DA spending fell immediately after implementation of VFC, but not in all cases (Figures 13 through 18). Different patterns of state spending for vaccines following the inception of VFC can be seen for UP states and states without UP. North Carolina and Washington, with UP programs, increased their absolute dollar investments in vaccine purchase in the latter half of the decade. These two states devote state-source funds to vaccine purchase of a magnitude comparable

Figure 12. Washington infrastructure spending by source of funds, 1994 –1999

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Figure 13. Alabama vaccine spending by source of funds, 1992–1999

to VFC expenditures. Figure 16 shows the average shares for North Carolina over the past 2 reported years as VFC, 41%; state-source funds, 43%; and the remaining 16%, Section 317 DA. For Washington (Figure 18), also averaging over the past 2 years, VFC accounted for 39% of publicly purchased vaccines; state-source funds, 36%; and Section 317, 25%. Alabama demonstrates the sharpest change between pre- and post-VFC periods (Figure 13). In 1992 and 1993, public purchases of vaccines were split roughly even between the state and Section 317. Beginning in 1994, VFC played a growing role in public vaccine purchases, replacing both Section 317 and state support. Savings accrued to Medicaid programs because of the substitution of all-federal VFC spending for Medicaid’s regular federal–state shared financing of vaccine purchases. Several of our sites, including Michigan, North Carolina, and California, reported using those savings for increasing the administration fee paid to providers

Figure 14. Michigan vaccine spending by source of funds, 1995–1999 (State spending for 1999 not available)

Figure 15. New Jersey vaccine spending by source of funds, 1992–1999

giving immunizations. California also reported spending state Medicaid savings for community health center support, management consultations to private providers, and registry development. New Jersey was the last state to implement VFC for providers in the private sector, beginning in January 1999. As might be surmised from the size of Section 317 and state expenditures for New Jersey, the public-sector presence in immunization is small, with just 10% of immunizations for children delivered in LHDs and other public settings (Figure 15). New Jersey is also unique in our case-study group; it has, by far, the smallest proportion of children living in poverty, and this population structure may well explain the relatively small public sector presence. A major benefit of VFC and UP programs is that immunization providers are saved the cost of acquiring and maintaining a vaccine inventory in advance of administration and third-party reimbursement. For non-institutional providers serving Medicaid enrollees

Figure 16. North Carolina vaccine spending by source of funds, 1992–1999

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Figure 17. Texas vaccine spending by source of funds, 1993– 1999

and other low-income children, this has proven to be a significant financial benefit. The relative advantage and advances of VFC from the perspective of the private provider have been less in states with UP programs than they were in states without expanded public purchase or Medicaid vaccine replacement programs prior to VFC. In UP states, VFC introduced eligibility and inventory documentation requirements over and above those required by the state program. Still, both VFC and UP programs have high provider participation rates, and can be credited with encouraging the shift from the provision of immunizations in public health settings to private practice settings in most states (Table 3).18,19 Fifteen states have UP programs. All had been operational before the implementation of VFC, with North Carolina the last to institute UP in January 1994. Maine has had a UP program for more than a decade, and Washington instituted its program in 1990. Notably, Washington’s UP program is not statutorily based; it is

the result of annual budget agreements between the state legislature and the state health department. Washington has its own Vaccine Advisory Committee, which approves vaccines for coverage under the state’s UP program after the national Advisory Committee on Immunization Practices (ACIP) does so. As a result, new vaccines may first be provided through the Washington UP program as late as 18 months after their inclusion in VFC. State immunization officials cite the tenuous legislative basis for Washington’s UP program, in conjunction with the increasing costs of new vaccines and the immunization schedule, as responsible for creating uncertainty about continuation of the state’s UP program as a mirror image of VFC. Michigan was the last state to have a publicly operated vaccine-production facility, which has been privatized and no longer produces childhood vaccines. This facility produced the diphtheria vaccine, which was then distributed free of charge to providers in the state, and also served as a source of revenue through sales of the vaccine to surrounding states. While this production facility was operating, the vaccine it produced for use in Michigan constituted the bulk of the state’s contribution to the public vaccine supply, which has diminished since the facility was sold (Figure 14).

The Changing Health Care Environment The Section 317 infrastructure-strengthening initiatives took place in the context of a period of major changes in the health care environment. These included the introduction of the VFC program in late 1994, which facilitated a shift in the provision of immunizations from public to private sector; welfare reform, which at least temporarily resulted in a drop in the numbers of children and adults enrolled in Medicaid; rapidly growing enrollment in Medicaid (and private) managed care; and initiation of the State Children’s Health Insurance Program (SCHIP). These programmatic reforms and marketplace restructurings occurred largely independently. This section traces the impact that each transformation had on state immunization efforts and performance.

VFC Program

Figure 18. Washington vaccine spending by source of funds, 1995–1999 (State spending for 1999 not available)

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The federal VFC program has dramatically affected the delivery of immunization services to children. At the beginning of the 1990s, most children who received publicly funded vaccines did so at public clinics, which were supplied with vaccine purchased with federal or state funds, or in private sites, which were supplied with vaccine for Medicaid children through a cumbersome dose-for-dose replacement system.15 All that changed following the enactment of the VFC program as part of the federal Children’s Immunization Initiative in 1993. VFC is an entitlement program that provides federally

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Table 3. Immunization policies and performance

Public health State jurisdictions

State vaccine purchase

Percent immunizations given in public/private # of VFC sectora providersb

ME

3 city health departments; otherwise, no local departments

UP

10/90

562 registered; No 465 received vaccine

89

⫹6.3

NJ

Local; 116 local health departments

Non-UP

10/90

133 public 744 private

Yes

85

⫹13.3

NC

79 counties have LHDs; UP remaining 21 served by 7 consolidated health districts

30/70

303 public 795 private

No

84

⫹3.8

AL

67 county health departments

Non-UP

35/65

240 public 228 private

No

82.1

⫹9.1

MI

43 LHDs, 7 serving multiple counties and 1 city health department

Partial state 37/63 purchase (for underinsured)

170 public 1249 private

HMOs only

79

TX

State serves areas not served by the 66 local health districts

Partial state 20/80 purchase (for underinsured)

412 public 7427 private

Yes, for plans since 1/98; no small employers

75

⫹6.3

WA

36 county-based local health jurisdictions

UP

20/80

206 public 907 private

No

81

⫹7.8

CA

47 county and 3 city LHDs; 11 small counties contract with state

Non-UP

20/80

937 public 3074 private

Yes

78

⫹5.9

First-dollar coverage required for private health insurancec

% Children NIS with 4:3:1:3 NIS completed, % change, 1998 1994–1998

LA

10/90

67

SD

10/90

73.5

National

79.2

⫹18

⫹5.2

a

Only state and local government services are considered public; Federally Qualified Health Centers are included in private sector. Maine, Michigan, New Jersey, and Texas, 1999; Washington, 1998; Alabama, California, and North Carolina, Centers for Disease Control and Prevention survey, October 1998. c Freed GL, Clark SJ, Cowan AE. Unpublished IOM background paper, November 1999. b

purchased vaccines to children aged ⬍1 to 18 years who are Medicaid enrolled, uninsured, American Indian or Alaska Native, or who are “underinsured” for immunizations and receive them from federally qualified health centers or rural health clinics. VFC-eligible children can receive the federally supplied vaccine in either public or private settings. Between 1994 and 1998, the NIS shows a decrease in the proportion of families who report receiving all immunizations from public clinics from 24% to 17%. The proportion reporting that all immunizations were given by private providers remained roughly the same, 57% in 1994 and 55% in 1998, while the proportion reporting that immunizations were received from a combination of public and private sector providers increased from 3% to 8% over this period. (The remaining respondents reported that their children received immunizations from hospital or military providers, or that they did not know [unpublished data on immunization provider type, Centers for Disease Control and Preven-

tion, 1994 National Immunization Survey, and 1998 National Immunization Survey]). The case-study states all reported a shift of immunization services from the public to private sector that is more substantial than the shift revealed by the NIS (Table 3). Washington state saw a particularly dramatic trend: In 1994 the public sector accounted for 80% of vaccine delivery and the private sector for 20%; by 1999 the figures had completely reversed. In Alabama the trend was also pronounced: Before the implementation of VFC, the public sector delivered 70% of the vaccines, and by 1999 only 35%. Alabama officials attribute the steep and dramatic increase of vaccines delivered in the private sector to the VFC program. Houston reported similar trends. Some states report that virtually all immunizations take place in the private sector; Maine and New Jersey report that the private sector currently accounts for 90%. A pediatrician in Newark, who practiced in an ethnically diverse neighborhood containing a substantial Am J Prev Med 2000;19(3S)

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number of Medicaid children (60% of her practice), explained this shift. Before VFC, immunization was a “big drag on cash flow” with Medicaid claims for reimbursement outstanding for 6 months or longer, while invoices for vaccines from private suppliers were due within a few months of delivery to the practice site. Under VFC, the vaccines are provided without cost, which relieves the practice of having large unreimbursed outlays for vaccine inventories. New Jersey’s Medicaid program also pays a relatively high vaccine administration fee, $11.50, which is passed through to providers by managed care contractors. The one complaint the pediatrician had was with the amount of paperwork required by New Jersey’s private VFC distributor. (Although all states must report to the CDC certain information on VFC doses, the CDC does not specify the actual reporting forms and methods that the states use to collect information from providers; VFC documentation systems in some states are more burdensome than in others.) State health departments are challenged by the shift in service delivery to the private sector; their efforts to assess and improve immunization programs have been focused on public providers. Most states have concentrated their provider assessment efforts on the relatively larger public clinics and have only recently begun to conduct these evaluations in the private sector. Oversight of the private sector is more difficult, both because providers are more numerous and because the health department has less leverage. The concurrent trend of expansion of managed care for vulnerable populations has also shifted responsibility to these organizations for ensuring immunizations to high-risk groups.

Welfare Reform A partial impact of welfare reform on immunization has been to offset the trend to private-sector health care, at least in the short run. Specifically, the introduction of Temporary Assistance to Needy Families (TANF) in 1996, along with unprecedented economic expansion, has led to a very sharp reduction in the number of people receiving public assistance. As families lost income assistance, they lost their automatic coverage for Medicaid. While children in many of these families were still eligible for state-supported child health insurance, their parents or guardians now had to apply separately for Medicaid or other coverage. Further, many families did not realize that children remained eligible for state-supported health insurance. The confusion around continued eligibility and the fact that an extra step was involved in applying for coverage apparently created barriers. Implementation of TANF was 66

accompanied by a 7% drop in Medicaid enrollment nationwide between 1996 and 1998.20 Some of our respondents believe that this disconnect from automatic coverage and the accompanying decrease in Medicaid roles may have increased use of public-sector providers.

Medicaid Managed Care For many of the case-study states, the growth in Medicaid managed care enrollment was the most substantial recent structural change affecting delivery of health care to children, including immunization delivery. Nationally, the percentage of Medicaid children enrolled in managed care has grown from 14% in 1993 to 54% in 1998 (Table 4). In almost all of the case-study states, managed care penetration was high for the Medicaid and SCHIP populations. For some (California, Michigan, New Jersey, and Washington), managed care is mandatory for nondisabled children and penetration is high. Managed care arrangements vary from primary care case management to partial-risk (primary care) capitation to full-risk capitation. The capitated payment to the MCO or primary care case manager includes at least primary care services. It is expected that children remain in their medical homes for these services, including immunizations. In some states, this apparently is occurring. However, others reported financial disincentives under managed care to immunizing children in their medical homes. One disincentive mentioned by many of the case-study sites is that the vaccine administration fee that physicians receive under the Medicaid fee-for-service payment has been rolled into the capitation payment under managed care. Physicians are no longer receiving a separate payment for the service of immunizing a child, although they continue to receive VFC vaccines. This change in financial incentives makes immunizing less attractive financially, and some respondents believe that it has led to referrals to public clinics. In Detroit, for example, surveys have shown that at least 80% of families report having a medical home or regular source of care, yet the health department estimates that 50% of the children and adults it immunizes have public or private insurance coverage for immunizations. Some states have developed mechanisms for the health departments to bill managed care plans for immunizations administered to their enrollees in order to discourage the practice of referrals to public clinics. This requires administration and recordkeeping that health departments may not be well equipped to perform. In Detroit, the health department is authorized by the state’s Medicaid contracts to bill health plans when it immunizes their enrollees, but it does not have the capacity to bill nor does it wish to, lest the process of collecting information from recipients become a

American Journal of Preventive Medicine, Volume 19, Number 3S

Table 4. Medicaid and SCHIP program characteristics SCHIP income maximume

State

FMAP,a 1998 (%)

% Children with Medicaidb

% Medicaid enrollees in managed carec

Medicaid vaccine administration feed

ME NJ

66 50

20 16

11 59

NC

63

27

69

AL MI

69 54

22 25

71 68

TX WA CA National

62 52 51

24 25 29 25

25 91 46 54

$ 5.00 $11.50 in MCO rates, passed through $13.71/1 dose; double for 2⫹ $ 8.00/dose $ 7.00/injection; $ 3.00/oral $ 5.00 $ 5.00 $ 7.50/dose

SCHIP enrollment, # ever served, FY 1999e

SCHIP program typee

Medicaid expansion (%)

Separate program (%)

Mixed Mixed

150 133

185 350

13,657 75,652

Sep. Plan

N/A

200

57,300

Mixed Mixed

100 150

200 200

38,980 26,652

Mixed Sep. Plan Mixed

100 N/A 100

200 250 250

50,878 Not implemented 222,351 1,979,450

a

Health Care Financing Administration (HCFA).21 Percentage data from 1996, cited in Annie E. Casey Foundation.11 c HCFA.22 d CDC/NIP, 1998 survey. e HCFA.23 FMAP, federal medical assistance percentages; SCHIP, State Children’s Health Insurance Program

b

barrier to immunization. As described above, New Jersey’s Medicaid managed care contracts direct plan administrators to “carve out” and pass the vaccine administration fee through to physicians, which both gives providers an incentive to immunize and creates a bill that reliably documents the immunization. A few of the case-study sites sounded warnings about the negotiated or competitively bid Medicaid managed care contract rates and the impact of inadequate rates for children’s access to primary care in their medical homes. For example, in Detroit, access to primary care services for Medicaid and other low-income residents appears to be declining, and may continue to decline as a result of oversubscribed and underfinanced Medicaid managed care contracts. This is reflected in both the reduced number of plans and service sites and in longer waits for well-child and immunization appointments. In California, private practitioners reported declines in the private physician base in the inner city and even bankruptcies of practices, which they attributed to capitation payments insufficient to support adequate primary care. Providers in California reported a further disincentive to immunize children in the SCHIP program, claiming that the capitation rate was calculated assuming that there would be a VFC-type program to supply vaccines free of charge to plan providers. Although such a program did not materialize, providers asserted that the SCHIP capitation rates were not adjusted to reflect the cost of pediatric vaccine purchases for enrollees. Thus, providers claim that they are severely disadvantaged financially when they serve a child of immunization age.

Monitoring Performance in Managed Care The movement to managed care has brought not only shifts in financial incentives, but also shifts in responsibility for services delivered and in responsibility for monitoring. The managed care plans have contracted responsibility for the care of the Medicaid and SCHIP children, including ensuring that they are up-to-date for immunizations, while the state has responsibility for monitoring performance of the health plans. In most case-study sites, health plans monitor immunization rates and report them as part of the Health Plan Employer Data and Information Set (HEDIS) requirements. In some states, the state then creates report cards from these data and publishes comparisons of plan-level performance. At the same time that states have lost the opportunity to monitor services delivered through claims submitted by providers, managed care plans have not yet developed the capability to assume that function. Health plans at many of the case-study sites report that provider-level data came from encounter forms, but that providers do not submit them because the encounter form does not generate a payment. In California, health plans were considering offering a small financial incentive to providers for submitting encounter forms, so that information on services delivered would be more complete. Another aspect of health plans’ ability to monitor performance surfaced in the California case study. Providers whom we interviewed reported that they contracted with most of the health plans in the area so as to ensure access to most potential patients. In Am J Prev Med 2000;19(3S)

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addition, private office-based physicians with whom we spoke reported that they contracted with several different Independent Provider Associations (IPA) groups as well. Each of the plans with which the provider contracts has responsibility for quality assurance, as do the IPAs for private providers. The multiple layers mean that the providers receive oversight from multiple entities. One two-physician practice with a large proportion of Medicaid patients reported that they had received eight distinct facilities reviews in the past year. These reviews involve examination of facilities and review of five to ten charts. They do not involve examination of the performance of the practice on specific quality indicators. Monitoring of performance, including immunization performance, was done through the HEDIS process, but the fact that most providers belonged to most health plans meant that the HEDIS survey was not likely to include a large enough sample from any provider to make feedback at the provider level meaningful. The providers with whom we spoke reported that they had not received feedback, and the immunization program reported that providers more generally complained about lack of feedback on performance from health plans. This is not a problem for California alone, but nationally as well. Applying a monitoring process that was designed for differentiated provider networks to the current, mostly undifferentiated networks has been recognized as a general problem.24 Notably, the Immunization Program in San Diego county proposed to the state Medicaid agency that it be delegated the task of monitoring immunization coverage levels and quality assurance for Medicaid managed care plans in San Diego county, but the Medicaid agency did not act on the offer.

State Children’s Health Insurance Program While the new SCHIP funding has enabled states to expand health coverage to uninsured children, it has also required states to design a new program and benefit package. The states we studied have adopted somewhat different strategies in terms of eligibility criteria for SCHIP, benefit packages, fees and copayments, and integration with the state Medicaid program. Despite differences in program design, many of our interviewees objected to the policy that children insured through freestanding SCHIP programs (i.e., those that are not eligibility expansions of Medicaid) are not eligible for vaccines supplied through the VFC program. Providers reported that keeping track of vaccines separately for children in the two state-supported child health insurance programs was administratively difficult and burdensome. Some of the state officials believed that this two-tiered policy would lead providers to refer SCHIP children to the LHD for immunizations. 68

In all of the case-study states, SCHIP is at least partly organized separate from Medicaid. Eligibility criteria vary across the case-study states for both Medicaid and SCHIP (Table 4). A typical configuration is for Medicaid to cover children in families with incomes up to 100% or 133% of the federal poverty level (FPL) and for SCHIP to cover children from 100% or 133% to 200% FPL. Alabama, Texas, and North Carolina have adopted those eligibility criteria. Washington has particularly generous eligibility criteria for Medicaid— up to 200% FPL for children through age 18; it is one of only four states with Medicaid coverage at or above 200%. In Washington, SCHIP covers children from 200% to 250% FPL. New Jersey has the most generous coverage for SCHIP: The Medicaid program covers children up to 133% FPL, but SCHIP covers children up to 350% FPL. States have different and sometimes complicated fee and copayment schemes for children covered by SCHIP programs. For example, in North Carolina, families with incomes above 150% of the FPL must pay annual enrollment fees of $50 per child or a maximum of $100 for two or more children and may be charged copayments for some services. Federal SCHIP law, however, prohibits copayments for preventive services, including immunizations. In Texas, families will be required to contribute to the cost of covering their children based on a sliding income-related scale; costs to families will range from $2 to $5 for office visits, $10 to $25 for emergency room visits, $2 to $10 for prescriptions, and premiums that range from $15 annually to $18 per month. The benefit package for SCHIP varied in the casestudy states, but were usually comparable to either the Medicaid Early and Periodic Screening, Diagnosis, and Treatment services (e.g., Washington and New Jersey) or to the benefit package for children of state workers (e.g., Michigan and California). With respect to benefits for immunizations specifically, states are required to cover all ACIP-recommended immunizations in their SCHIP benefit package. The differences in the Medicaid and SCHIP requirements may pose problems for families whose incomes fluctuate, and who therefore move between these two programs. Furthermore, because the eligibility requirements are different for different age groups, families may have children in both programs. Differences in programs mean that families need to learn the rules for and to negotiate within two state systems. The program in New Jersey deserves special mention because it was designed to avoid some of these problems and to be as seamless as possible for both the provider and the patient. In New Jersey, state-supported child health insurance goes by the same name for both Medicaid and SCHIP, “NJ KidCare.” It has four different levels ranging up to 350% FPL; the first tier is Medicaid and the remaining three are SCHIP. The

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application process is similar, advertisements for both occur at the same time, and both programs are administered by managed care plans under contract with the state. At the physician level, vaccine reimbursement policy is the same for all children, whether they are covered by Medicaid or SCHIP. Children covered by Medicaid receive vaccines through the VFC program; children covered by SCHIP receive vaccines purchased by the state. The state uses a portion of the state funds allocated to the SCHIP program to purchase vaccines at the CDC contract price and distributes them to physicians for children in SCHIP tiers of the NJ KidCare program. Thus, physicians receive vaccines up front and at no cost to them for children in all statesupported insurance programs.

Immunization Programming During the Decade The renewed focus of federal and state health leaders on immunization following the 1989 –1991 measles outbreaks resulted initially in programmatic enhancements that were similar to previous initiatives (e.g., extended public clinic hours, mobile vans, public awareness campaigns, and special immunization days). Yet the revitalized and expanded Section 317 program and its partners in state health agencies were operating in a rapidly changing health care financing environment, and had to take VFC, Medicaid managed care, and new information technologies into account. As Figures 2 through 6 show, states were not able to spend the new funds as rapidly as they were awarded. Much of the lag was due to the time it takes state bureaucracies to approve new positions, process contracts for goods or services, and other administrative procedures needed to spend money. In some states, special approvals were needed or particular local requirements further slowed down spending or limited ways in which Section 317 funds could be used. For example, the Texas legislature had imposed a limit on the number of state employees, whether funded with state revenues or not. In time, the health department gained the ability to pay for more overtime, allowing the agency to provide evening and weekend clinic hours and comply with the legislatively set staffing limit. In Houston, a direct Section 317 grantee, city council approval is required for receipt of all grants in excess of $15,000, also delaying use of funds. Michigan, by contrast, could easily absorb additional funds by making awards to LHDs through existing multifunction contracts. Even ready absorption at the state level was no guarantee that services would be augmented, however. When Detroit experienced a fiscal crisis, the city required employees, including immunization nurses funded with Section 317 funds, to take one day of leave without pay per pay period, reducing immunization service hours and Section 317 expenditures.

By the mid-1990s most obstacles to program expansions had been overcome and states had launched new programs. Funds were used in a variety of ways, including service delivery, outreach and education, media campaigns, immunization activities in the U.S. Department of Agriculture’s Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and income maintenance offices, and monitoring and assessment of coverage levels in provider sites. When funding levels were reduced in the later 1990s, states had to set priorities and decide which activities to continue and which to reduce or eliminate. Over the decade, the policy emphasis in immunization service delivery had shifted from public to private sector provision and the importance of a medical home was accentuated. The reduction in funding coincided with a reordering of priorities from service delivery to oversight and monitoring.

Service Delivery Initiatives The largest use of expanded Section 317 funds was to increase the supply of public-sector service delivery. New immunization clinics opened, existing clinic hours lengthened, and newly hired public health nurses began providing immunizations in new settings. In the early years, the growing realization that underimmunized children participated in a variety of social service programs such as WIC, Aid to Families with Dependent Children (AFDC), and food stamps led to expansion of immunization services at these sites.25 The notion of immunizing children where they could easily be found led states to experiment with immunization vans and other mobile and off-site services. The changing context had made what seemed innovative early in the decade outdated by its end. Standalone immunization conflicted with the model of providing immunization in a medical home. Also, the nontraditional settings proved to be relatively more expensive places to deliver services. New Jersey had out-stationed public health nurses to each of its county social services offices to allow children to be immunized at the same time their parents applied for or renewed their participation in public assistance programs. The effort continues in one county, Essex, home to the state’s largest city, Newark, and the state’s largest public assistance population. Elsewhere, the number of doses administered in relation to the cost of staffing the clinic made the cost-per-dose-administered appear too high at a time total resources were falling. (Unasked was the question of how many doses were administered to children who were unlikely to receive them in a medical home; depending on the answer, their cost-effectiveness may have been higher.) Additional 317 funds also supported additional state health department staff with no direct service responsibilities. Often these staff were field based, with broad Am J Prev Med 2000;19(3S)

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responsibility for improving immunization. Both Michigan and Alabama added staff responsible for defined geographic areas. Their responsibilities ranged from serving as intermediaries between service providers and state programs to resolve problems to consulting with providers using the CDC-developed Clinic Assessment Software Application (CASA) and Assessment, Feedback, Incentives, and eXchange of information (AFIX) management tools. Alabama also added staff who provided case management solely for immunization. These staff used birth-certificate data to identify children likely to be at high risk who were then followed until they were aged 24 months or completed their ageappropriate immunizations. California counties used Section 317 funds to support community-based promotoras (promoters) to assess and encourage activities in the communities where vulnerable children live. Most of these service activities have been severely curtailed or eliminated entirely with the reduction in funding, and the emphasis has moved to oversight and monitoring. In some cases, the reductions are in line with the new focus and responsibilities of public health agencies. In others, states and LHDs are reducing or eliminating programs with reluctance, and without having reformulated their roles vis-a-vis public insurance programs and private health plans.

the state’s immunization newsletter. In North Carolina, the state tries to make 250 annual site visits to private providers for professional development and quality assurance, almost one third of the private providers enrolled in VFC. San Diego and Los Angeles counties perform CASA assessments in the public clinics annually and “Casita” assessments (which involve reviewing a smaller number of charts) in private provider sites on a rotating basis.

From Service Delivery to Assurance

School Entrance and Age-Appropriate Immunization Requirements

In addition to the growth in the supply of immunization services and the number of nondirect service staff in state immunization program offices, increased Section 317 funds also facilitated a qualitative shift in the activities of state immunization programs. These expanded beyond service delivery and outbreak response to include quality improvement. Quality improvement efforts seek, in part, to increase the rate at which providers keep children up-to-date. In their solicitation of Section 317 grant applications, the CDC set out required activities, and through this process put each state in the business of monitoring immunization coverage in clinics and practices. A program in Georgia clinics that succeeded in raising immunization coverage by 36 percentage points (from 53% to 89%) over a 7-year period set the stage for an increased emphasis on monitoring and feedback.26 This Georgia program, which involved assessing coverage, feeding back results to clinics, comparing rates with those of neighboring clinics, and giving incentives for improved coverage led to the CDC’s AFIX strategy and the CASA methodology. State health departments have more leverage over public providers than they do over those in the private sector to encourage participation in quality improvement activities. Michigan relies on positive incentives to encourage private providers to participate in practice assessments. Those with high results may be featured in 70

Public/Voluntary Partnerships Financial support was not the only form of additional infrastructure resources provided by the federal government. The focus on immunization at the national level created an environment that allowed states to expand the ranks of their immunization partners. A state-level initiative in Texas that began in 1993 led to the creation of 200 local immunization coalitions. Corporations and foundations provided support, and in Texas, the support topped $1 million in its peak year. Nationwide, Hallmark Cards offered four-color infant immunization reminder greeting cards to health departments in all states and territories. While the Hallmark card collaboration continues, many of the initiatives and efforts were one-time or for a limited time.

In many respects, a state’s immunization program is only as strong as the relationships it forges with other programs and agencies that serve the same constituency. In every state, enforcement of immunization requirements for school and daycare entry are responsibilities shared with state and local education and social services agencies. Some states also have ageappropriate immunization laws that lend weight (even if not actively enforced) to the notion of immunization as a parental duty that, if neglected, has public and legal consequences. Texas and North Carolina have such laws. The enforcement of school entrance laws involves substantial local resources beyond the state’s immunization budget. Generally, state and LHD staff conduct sample reviews and audits of school system immunization records collections and verifications. The importance of such requirements is illustrated by Michigan’s initiative in the early 1990s. Beginning in 1994, school districts that did not have at least 90% of school entrants in compliance with state immunization requirements were subject to having 5% of their state aid withheld until they reached 90%. In 1995, the standard was raised to 95% compliance. Through a combination of better documentation and catch-up immunization, all districts reached 90% compliance within a few weeks of the end of the 1994 school year. Since that time, all

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school districts have met the 95% standard for new entrants. In Texas, after the publication of a Children’s Defense Fund survey that ranked Texas last nationally in the percentage of 2-year-olds with up-to-date immunizations, the state legislature passed legislation in 1993 mandating age-appropriate immunization of every child in the state. State appropriations almost doubled for the 1994 –1995 biennium from the previous one ($40.3 million to $72.2 million) to implement this mandate. The additional funding went to increased vaccine purchases, infrastructure expansions, marketing activities, and the development of a statewide immunization registry.

WIC Linkages Perhaps the most crucial program linkage for infants and preschoolers is the U.S. Department of Agriculture’s WIC nutrition counseling and food supplementation program. The overlap of populations served by WIC and immunization programs is high, and WIC contact with mothers of infants is relatively frequent during the critical first 2 years of life. Nationally, WIC serves 45% of the national birth cohort, and in some cities up to 70% of all infants. The federal WIC program articulates a regulatory responsibility to coordinate with other health services, in addition to its primary objective of improving the nutritional status of children aged ⬍5 years and of pregnant and lactating women. Likewise, CDC program guidance to state immunization programs requires that state immunization programs collaborate with WIC to plan and conduct immunization record review and referral to immunization providers. Some local WIC sites and programs receive financial support from state or county immunization programs to provide immunizations directly, in addition to conducting records review and referral. Although federal appropriations report language has directed that a certain portion of Section 317 grants be devoted to immunization-related services by WIC agencies, this legislative intent has not been strictly enforced by the CDC. To varying degrees, however, states and local immunization programs have engaged in collaborations with state and local WIC agencies, and have voluntarily supported immunization-related services at WIC sites. Conversely, WIC agencies have in some cases devoted their own resources to enhanced support for immunization services, beyond the general coordination requirements of the national WIC program. In Texas, for example, WIC clinics began to offer immunizations beginning in 1993, before new state funds were appropriated for expanded immunization services. Increased Section 317 FA grants in the mid-1990s made it relatively painless for state immunization pro-

grams to transfer funds or enter into contracts with WIC agencies for supportive and direct immunization services; the pot was growing. Stand-alone WIC automated databases containing immunization information or tie-ins with state immunization registries were one activity in which states invested immunization funds. Maine, for example, invested 317 funds in years with carryover funds to upgrade WIC computer software. By 1999, with the effects of grant reductions fully felt by the states, much of this financial support for immunization-related WIC efforts had ended, although WIC agencies are still expected to review immunization records and refer. Some of the program interactions and changes we learned of are summarized below. ●

●

●

●

In Alabama, 60% of infants in the state are enrolled in WIC, and immunizations are given in WIC clinics. Section 317 funds are used to support this service delivery, although both state and Section 317 funds supporting WIC immunization services were reduced in 1999. Approximately 80% of WIC-eligible infants and children have records in the county health department registry. In both LA and San Diego counties, 70% of the infants are WIC eligible. In San Diego, WIC programs review immunization records and refer families to immunization providers. In Los Angeles, in contrast, about half of the 60-odd WIC sites have been directly providing immunizations. These services are projected to be phased out by June 2000, due to decreased funding. In Texas, Health Department support of WIC decreased from $2.4 million to $1 million in 1999. (WIC clinics in Texas see 500,000 infants every month.) North Carolina spent $500,000 of its Section 317 funds each year in 1997 and 1998 to support WIC screening, referral, and outreach. This support was eliminated in 1999.

The inconstancy of immunization program support for WIC-based immunization activities has led to some tensions between the programs at the state and local levels. WIC programs perceive themselves as accountable for conducting resource-intensive record review and referral, but without any or adequate financial support from the state or local immunization program. WIC programs may also be philosophically at odds with a CDC-endorsed strategy to require monthly WIC voucher pickup (MVP), rather than issuing 3-month food supplement vouchers, in cases where children’s immunization records are not presented or up-to-date at the WIC interview. Although program evaluative studies have shown MVP to be an effective intervention in increasing immunization coverage levels among WIC families,27 WIC program personnel believe MVP to be fundamentally punitive and contradictory to the relationship the program cultivates with its clients. Fiscal Am J Prev Med 2000;19(3S)

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72

Private provider participation lags far behind public providers

317 FA funds, state and local funds; Medicaid administrative support; provider fees; foundation support 317 FA funds; state funds; initially, RWJ Foundation support

Public sector supplies data; private offices not connected but report doses under UP on paper

317 FA funds; initially, RWJ Foundation supported pilot project

Statewide; all public providers supplying data

317 FA funds; Title V funds; state funds

Public providers supply data; private participation less clear

317 FA funds; state funds; Medicaid MIS support; private support

Serving 40 providers; plan to reach 100 largest in 2000, remainder in 2001 Uneven across counties

317 FA funds; state funds; foundation support

Single statewide; events recorded for 30% of ⱕ24month-olds Single statewide, representing children whose parents “opt in” Developed as public only; expanded to VFC private providers Single statewide

State funds to counties from Medicaid VFC dividend; foundation support to some counties

Missouri Minnesota

Single statewide

317 FA funds; state funds

Includes county health departments with planned expansion to private providers

Structure

Financing

Functional status

California Alabama State

Table 5. Registry status

Assessment and documentation of immunization status are complicated by the movement of people geographically, and among particular health care providers and financing systems. States, local communities, and private health plans have created electronic registries to monitor immunization coverage rates within a given geographic area or health plan. Immunization registries are “confidential, computerized information systems that contain information about immunizations and children.”28 Although immunization registries have existed since the mid-1970s, major interest in a centralized repository developed after the measles outbreaks that began in 1989. Both the CDC and the Robert Wood Johnson (RWJ) Foundation responded with registry initiatives. Registry development in each of the case-study states has been funded through the federal initiative begun in 1993 as part of the Childhood Immunization Initiative, the RWJ All Kids Count program, or both (Table 5). With increased Section 317 FA grants, registry development became available to all of the federal grantees. As of 1999, all states and most of the federal immunization grantees (61 of the 64) were developing or implementing registries using these federal funds. A 1999 survey of these grantees reported that 69% are implementing registries and almost all of these involved at least one other health care program.29 Further, as substantial numbers of children appear to have extra immunizations (approximately 21%), and as having multiple providers is strongly associated with extraimmunization, registries have the potential to improve health care and reduce system costs.30

New Jersey

Registry Development

Single statewide

North Carolina

Texas

Just as expenditure increases lagged behind resource increases, the availability of carryover funds allowed the decline in expenditures to lag behind lower levels of new resource commitments in more recent federal FYs. States are now adjusting to the lower level of federal funds. As states have not replaced lost federal funds, state agency officials are reducing program commitments. In Alabama, this has meant the state is not filling 317-funded positions when they become vacant. It is also deferring plans to increase or add new vaccine requirements for day care or school attendance because of a lack of capacity in the LHDs to deliver any newly required immunizations. Similarly, at a time when the NIS point estimates show declining rates of coverage in Houston, more detailed coverage surveys to identify the pockets of highest need within the city are seen as unaffordable luxuries.

Statewide; joint with New Hampshire; Internet-based

Declining Section 317 Financial Assistance

County based; moving to state/regional “hubs”

Washington

and programmatic signals between immunization and WIC programs are both vital and mixed.

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Course of Registry Development and Implementation Registries were at different stages of development in each of the sites, and the information architecture and policies also varied. All of the case-study sites shared a growing appreciation for the major commitment in funding and time involved in developing and maintaining an immunization registry. Most registries had begun in pilot sites, often with private monies, in the early 1990s.31 Technical policy development for most took place in the early and mid-1990s with private grant support, and sometimes by nonpublic organizations on behalf of the state health department. When the first wave of grant or foundation funding ended, some registries moved into statewide operation, under the auspices of the health department, with major support coming from Section 317 funds. This transition was eased by the fact that the states had a ready source of funding in the Section 317 carryover dollars. The registries in the case-study states are facing another important juncture now. The Section 317 carryover funds have been spent and states are struggling with the problem of how to support large registry operating budgets, which in these seven states were always over $1 million and as high as $3.5 million annually. The immunization registry in New Jersey is typical of this evolution. Development of the New Jersey registry was funded by the All Kids Count project, with a pilot registry with some supplemental Section 317 funds from 1994 through 1996, at $1 million annually. The state took over the operations at the end of the grant period, in June 1997. At that time, the New Jersey registry moved from a local pilot registry to statewide deployment. The immunization registry required an annual operating budget of $1 million, which the state funded with Section 317 carryover funds. The annual operating budget is still at least $1 million and depends on federal funds to continue operations. The immunization registry in the state of Washington, called CHILD Profile, followed a similar course in development. It began as a pilot project in 1993 in the Snohomish Health District and Seattle–King County Department of Public Health with support from the All Kids Count project. A private company developed it, but in 1997 it was adopted by the state Department of Health as its model and has been marketed throughout the state since then. Washington state is also struggling to develop a funding stream for registry operation.

inal registry design called for a series of small-area registries, all funded with Section 317 dollars, and in California the original design was for county registries. Both states saw value in more standardization and centralization, and have evolved into a statewide registry (Michigan) or large-area registries with a state hub (California). Most registries are populated with electronic birth certificate data so that demographic data for the population of children born in the state is entered automatically. Some registries import legacy databases, such as Medicaid claims data or information from extant county registries. The registries can produce immunization histories for providers and some permit parental access to the registry as well. The set of functions and services described for the immunization registry in Maine (which was co-developed with New Hampshire) are typical of those available now or in the planning stages in the other states, and include the following: ● ●

● ● ●

Providing information to health care providers about the immunization status of the children they care for. Keeping track of the amount and type of vaccine providers are using, as well as ordering and shipping vaccines as needed. Helping providers to identify children whose immunizations are due or overdue. Giving providers information that can be used for continuous quality improvement in their practices. Analyzing immunization rates by region and local area to help public health officials identify areas where children are unprotected and are at risk for preventable diseases.

The states we studied differ in provider reporting requirements. In most states the participation of providers in registries is voluntary, with public providers generally submitting data and private providers far less likely to participate. However, participation is not voluntary in at least one of the case-study states. In Texas, state law mandates that providers report each immunization given to children whose parents or guardians have signed a consent form (written consent is required before immunizations can be reported to the registry). In contrast, in Washington the Medicaid program is reluctant to require providers to report immunizations. The state has no plans to mandate VFC providers’ participation or to require the Medicaid managed care plans to participate.

Registry Design

Problems and Issues for Future Development and Sustainability of the Registries

Immunization registries in the case-study states have a number of similarities. First, all have evolved into statewide or large-area systems, although in some states the original intent was to have a series of county or small-area systems. For example, in Michigan the orig-

The surplus of funds that states experienced in the mid-1990s in the form of Section 317 carryover dollars facilitated registry development at that point. States now have made extensive investments in registry development and hope that their registries will soon realize Am J Prev Med 2000;19(3S)

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their promise as important program assessment and practice management tools. In the states we studied, registries were on the cusp of becoming useful as an analytic tool in efforts to improve immunization coverage, but are not yet there. Most public-sector immunization providers are participating in registries in the case-study sites; it is more difficult to obtain participation from private-sector providers. In Washington, for example, in 1999, between 72% and 84% of the public providers were enrolled in the registry, whereas only 13% to 32% of the private providers were, and fewer private providers submitted data. In Alabama, the registry extends statewide for county health departments only, with Blue Cross and Blue Shield, the dominant insurance company in the private sector, involved in the planning phase. In North Carolina, connecting the immunization registry developed for the public sector with private providers’ offices has not been feasible because the registry uses a now-outdated mainframe computer. Providers in North Carolina who participate in the state’s UP program are required to submit a paper form reporting immunizations given, which are then entered into the registry, but private providers, because they are not connected, will not have access to the data they send. In Michigan, all public providers currently do supply data to the immunization registry, but compliance of private providers is less extensive. The Michigan registry reportedly receives very few queries from providers. Currently, then, the services that most immunization registries provide are not sufficiently valuable to private providers to compensate for the time it takes to report immunization histories. This equation may change, however. In California, a Kaiser Permanente representative reported that the organization’s employer contracts now include penalties if immunization rates for enrollees do not reach specified levels. This radically changes the value of a registry to providers, because it is a source of information on immunizations received outside the plan, which would boost Kaiser’s performance score. With the funding reductions in Section 317 and foundation grants coming to an end, states are struggling with funding registries over the long term. Most depend on Section 317 funds to support much of the costs and may not be able to sustain registries without this source of funding. Many of the states are pursuing other public and private sponsors. Michigan has begun to allocate registry costs to Medicaid in proportion to Medicaid’s share of the children represented in the registry. Similarly, in Alabama, discussions are ongoing with Health Care Financing Administration (HCFA)/ Medicaid to reimburse the state for information provided or to assist in absorbing system maintenance costs. Washington is attempting the unusual strategy of 74

charging providers for services. Registry operating costs are shared with participating providers, local health jurisdictions, and health plans through subscription arrangements. Providers are charged for each child under age six for whom they are the primary provider, with fees ranging from $0.13 to $0.39 per child each calendar quarter. It is not clear how successful this strategy will be. Private providers and the state chapter of the American Academy of Pediatrics have expressed an unwillingness to pay for the registry. The experiences in the states we examined reflect what is happening in all states as they search for sources of financing for these very expensive endeavors. A recent survey of immunization program directors reported that “registry development was the most common activity for which states were looking for additional funding.”15 States need both funding and an inducement for private practitioners to report immunizations if registries are to become an important tool for raising immunization rates. Providers view immunization registries as both necessary for ascertaining individuals’ immunization status, because of service/record scatter, and as an expensive and unwieldy system without immediate payoff.

Adult Immunization Adult immunization has been an underdeveloped part of national, state, and local public health immunization efforts.1 Section 317 began as a program for financing pediatric vaccines and, although the authorizing legislation for the program was extended in 1984 to include vaccines and immunization services for persons of any age, the CDC did not direct its grantees to use Section 317 grants for adult immunization until 1997.31 Thus, although ACIP recommended annual influenza immunizations for persons aged ⱖ65 since 1963, and a one-time pneumococcal immunization for older persons since 1984, the single federal categorical grant program for immunization services has only recently begun to address adult immunization as a core program activity. The CDC directs their Section 317 grantees to spend at least 2% of respective awards on adult immunization activities, and most states report to the CDC that they spend just that amount. Current ACIP practice recommendations include universal annual influenza immunizations for all persons aged ⱖ50 as well as adults with indications or risk factors for 11 other vaccines, including pneumococcal, hepatitis B, and tetanus. Thus, the adult population for whom one-time or annual immunizations are indicated is quite substantial. The extent to which some or all of these immunizations are covered by private insurance plans cannot be readily ascertained from existing industry surveys and reports.1

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Source: CDC.32

Pneumococcal, ever: 47.5 (42.3–52.7) 49.8 (45.8–53.8) 50.0 (44.3–55.7) 45.6 (40.4–50.8) 33.9 (29.3–38.5) 50.6 (46.7–54.5) 44.4 (38.8–50.0) 51.6 (47.1–56.1) Range: 32.2–59.4 persons Median: 46 65⫹ years (95% C.I.)

62.6 (57.5–67.5) 65.5 (61.7–69.3) 72.1 (66.7–77.5) 63.6 (58.6–68.6) 60.7 (55.9–65.5) 64.6 (60.8–68.4) 68.0 (62.8–73.2) 70.2 (66.2–74.2) Range: 54.3–74.4 Median: 66 Influenza: persons 65⫹ years (95% C.I.)

47.2 (38.5–55.9) 48.9 (41.2–56.7) 79.9 (70.4–89.5) 51.9 (43.5–60.3) 56.9 (47.2–66.5) 56.7 (49.2–64.2) 50.2 (41.2–59.3) 63.0 (54.5–71.5) Range: 37.7–70.6 Influenza: persons with diabetes (95% C.I.)

Michigan Maine California

State and municipal officials in the states we examined and the sites we visited presented a positive picture of their interactions with Medicare Peer Review Organizations (PROs), private entities within the state that contract with the HCFA to perform quality assurance and utilization oversight for Medicare, and with Medicare’s fiscal intermediaries, who process and pay physician and clinic claims for immunizations and other services. To the extent that state immunization programs have engaged in adult immunization education activities, aimed at both consumers and practitioners, they have often been in collaboration with the Medicare PROs or fiscal intermediaries. In many states, the Medicare PRO has identified increasing pneumococcal coverage rates among Medicare beneficiaries as a performance measure in their scopes of work. Public clinics have been able to receive payment for administering vaccines to Medicare beneficiaries, and report that the fiscal intermediaries have simplified the billing requirements for them. New Jersey is a notable leader in adult immunization activities; the importance the state places on health services to older adults is underscored by the dual missions of its oversight agency, the state Department of Health and Senior Services. New Jersey is one of just three states that requires nursing homes to offer influenza and pneumococcal immunizations to their inpatients, and is the first to require hospitals to do so as well. The New Jersey DHSS offers leadership and

Table 6. Immunization coverage rates for certain high-risk and elderly adults, 1997 (%)

State Activities

New Jersey

North Carolina Texas

Washington

National

The Medicare program for the elderly, disabled, and persons with end-stage renal disease has been an important part of the increase in (primarily elderly) adult immunization coverage for influenza and pneumococcal pneumonia during the past decade. Ninety-four percent of persons aged ⱖ65 years are covered by Medicare Part B, which includes immunization benefits. Medicare has covered pneumococcal vaccine since 1981, and began covering annual influenza immunizations for all beneficiaries in 1993, following a 5-year demonstration project. As can be seen in Table 6, coverage rates for adults aged ⱖ65 for these vaccines are, in general, substantially higher than those of younger, high-risk diabetics. In addition, the variability in coverage rates is lower among the individual states for those covered by Medicare than for diabetics, who may be uninsured or have insurance that does not cover immunizations. The narrower range of coverage rates for the elderly suggests that the uniform and universal coverage and promotional policies of the national Medicare program may have some positive effects on patient and provider compliance with ACIP recommendations.

Pneumococcal, ever: 38.1 (29.6–46.6) 33.6 (26.1–41.0) 41.1 (29.1–53.1) 40.1 (31.8–48.5) 30.5 (21.6–39.4) 39.7 (32.1–47.2) 27.0 (19.2–34.8) 43.7 (34.7–52.7) Range: 22.0–48.6 persons with diabetes (95% C.I.)

Alabama States

Medicare Coverage of Immunizations

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technical assistance for adult immunization but little direct funding, consistent with the state’s overall strategy. Still, almost two thirds of state-appropriated Health Care Priority Funds that are provided as discretionary grants to LHDs went for older adult immunization activities in 1999 ($97,000). Thirty percent of influenza immunizations for Medicare beneficiaries in 1997 were given in public health clinics in New Jersey, a substantially higher proportion than for pediatric immunizations, 90% of which are given by private providers. In 1999, New Jersey began to develop a statewide influenza pandemic strategic plan. The New Jersey Medicare PRO has performed AFIX assessments of 450 physicians in six counties in the state, using Medicare claims information for influenza and pneumococcal immunizations. Although the total investments that states make in adult immunization is limited, when states do purchase vaccines with their own funds, they use some of these funds for adult vaccines that are not provided through Section 317 DA. The California Health Department, for example, spends approximately $3.1 million annually on vaccines, a third of which is for adult pneumococcal and influenza vaccines. Los Angeles county receives these state-purchased vaccines, which are distributed to over 700 sites, including immunization projects and outreach programs, community health centers, and skilled nursing and dialysis facilities. In San Diego county, a voluntary consortium works with the county immunization program to operate a hotline during influenza season to direct callers to places offering influenza shots. San Diego also includes adults aged ⱖ65 years in their county-conducted telephone survey of coverage rates for influenza, pneumococcal, and tetanus coverage.

Conclusions The past decade has been one of rapidly changing conditions, expectations, and strategies for state and local immunization programs. These programs have had to adapt to and increasingly work within health care financing programs that themselves have been undergoing structural changes. Furthermore, categorical federal support for immunization program infrastructure through the Section 317 FA grants first grew rapidly and then declined below the maximum level of program expenditures and activities that the states reached between 1996 and 1998 (Figure 2). Section 317 FA grants, while playing a vital role in supporting states’ public health infrastructure, have been too unreliable to elicit and underwrite state and local strategic planning, programming, and commitment of resources. Thus far, the states we studied have not replaced federal support with their own dollars. The result is shrinking programs. It is too soon to conclude either that immunization is a low fiscal priority for states or 76

that there is simply a lag between feeling the impact of lower service levels and state budget cycles. Staterevenue support for immunization activities has been steadier during the past decade than federal support has been. Although states have not yet moved to pick up the slack created by smaller federal grants, they have not withdrawn their own investment in immunization programs. UP states, notably, have more than sustained their own investments in the purchase of vaccines, as ACIP and VFC policies have resulted in increasing the number and average cost of vaccines in the childhood complement. Keeping pace with the rapidly growing preventive and therapeutic armamentarium of vaccines requires a degree of policy coordination, foresight, and political will that has not yet emerged in the national health policy arena. As additional and more costly vaccines are licensed, and new age groups targeted for immunization coverage, investments in the public (and private) good of immunization should increase as a matter of public health policy. Yet issues of which payers (public/ private and federal/state) bear which costs of vaccine purchase and immunization programs have not been sorted out, and the consequences of this policy leadership default are likely to include suboptimal levels of population immunization coverage. The VFC program, constructed for the most part as an entitlement for Medicaid and uninsured children, is able to accommodate new ACIP recommendations relatively easily. As a substantive federal entitlement, VFC is given an indefinite appropriation for “such sums as are necessary,” as part of Title XIX of the Social Security Act. States with free-standing SCHIP programs are disadvantaged in terms of vaccine purchases relative to states that implemented expanded Medicaid programs. VFC by itself was a significant step forward in child health policy and SCHIP was another important advance; together, however, in implementation they amount to less than the sum of their parts. Finally, through the lens of immunization activities, we gained a view of public health agencies at the state and local levels at the end of a decade of realignment of health financing and service delivery programs. The role of public health agencies in the direct delivery of services is shrinking, while the need for these agencies to perform oversight and public, population-based health assessment and assurance has increased. These functions have also become more challenging with the increasing internalization of services and information transactions within managed care organizations. Most public health agencies we observed have not acquired the bureaucratic nimbleness necessary for assuring immunization in the parts of the system beyond public health agencies’ direct control. For example, Medicaid capitation contracts could provide incentives for immunization performance or recognize the additional costs of providing immunizations by setting

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age-specific, per-enrollee, per-month rates. Next, in states where insurers are required to cover immunization services, immunization programs have not forged ties with their colleagues in state government who regulate health plans. Local public health agencies have not adapted their staffing and authorities to meet these new demands, and sustaining the national immunization effort will require continued federal and state leadership and support if local agencies are to make this transition successfully. The federal–state immunization partnership changed more over the 1990s than in any other period since the federal government first provided assistance to the states in the 1950s. It is not yet in equilibrium, and further change is likely. Greater stability in federal financial support is needed for more rational development of immunization policies to sustain and strengthen protection against vaccine-preventable disease. We thank the many state and local public health officials, budget analysts, CDC public health advisors, health plan executives, and practitioners and other providers in each of the study sites for their generous assistance. The state and county staff invested considerable time and effort to meet our requests for information. We are particularly indebted to the conscientious work of many officials in each of the sites who voluntarily provided us with extensive reports on program spending during the past decade so that the IOM Committee could gain some insight into state and local program financing decisions and trends. Finally, we thank Bernard Guyer, David Smith, chair and vice-chair of the Committee on Immunization Finance Policies and Practices; the members who guided our efforts and conducted the site visits: Committee members Russell Alexander, Gordon Berlin, Steve Black, Samuel Katz and Jane Sisk; and Rosemary Chalk, study director.

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