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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Suggested Citation:"4 Program Management and Administration." Institute of Medicine. 2009. A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results. Washington, DC: The National Academies Press. doi: 10.17226/12585.
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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

4 Program Management and Administration As briefly outlined in Chapter 1, Title X of the Public Health Services Act established four areas for grants and contracts by the Secretary of Health and Human Services: family planning services, training, research, and informational and educational materials. Grants for family planning services can be made to states, and grants or contracts for these services can go to public or nonprofit private entities. Grants and contracts can also go to public or nonprofit private entities and individuals for training, research, and information and education. The budget for the Title X program was $300 million in fiscal year (FY) 2008. By statute, at least 90 percent of that appropriation must be used for family planning services. The Title X program has been implemented through regulations (42 CFR 59; see Appendix C) that detail the requirements for recipients of Title X funds. The program is administered by the Office of Family Plan- ning (OFP) (also referred to as the Central Office) within the Office of Public Health and Science, Office of Population Affairs (OPA), at the Department of Health and Human Services (HHS) and a decentralized sys- tem of 10 Regional Offices through which funds are provided to grantees in all states, the District of Columbia, and U.S. territories. This chapter examines the administrative and management structure of the Title X program, the services and other program activities it encom- passes, and its role in relation to other public or private funding sources. The information provided was drawn from Title X documents (for example, the Program Guidelines) and the commissioned paper authored by The Lewin Group, Inc. (see Appendix J this volume). In preparing this paper, The Lewin Group conducted a limited scan of published literature, government 101

102 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM and private-sector reports, and other information. It also conducted a series of interviews with Central Office staff, regional program staff, and Title X grantees and delegates, focusing on the administration and management of the program. This chapter also draws on testimony provided to the com- mittee at its public workshops by current and former grantees, as well as regional program staff, and on information obtained during the committee’s site visits (see Appendix A for a description of the workshops and lists of participants). The first six sections review in turn the roles and relationships of the Central Office, Regional Offices, grantees, and delegates; the applica- tion process for grants and contracts; the types and distribution of grantees and delegates; and the services provided by, oversight of, and funding of grantees and delegates (including coordination with other federal sources of funding for family planning services). The chapter then presents the committee’s assessment of the program’s management and administration. The final section offers conclusions and recommendations. Central Office, Regional Offices, Grantees, and Delegates: Roles and Relationships OFP, the Central Office, is responsible for the overall administration of the Title X program. As noted above, it is located in OPA, the primary divi- sion of HHS that advises the Secretary and Assistant Secretary for Health on reproductive health. OPA is headed by the Deputy Assistant Secretary for Population Affairs, whose responsibilities include implementation of the Title X program and the Adolescent Family Life and Research program, authorized under Title XX of the Public Health Services Act. OFP develops national priorities and initiatives, policy, performance measures, budget requests, spending plans, and funding announcements for the program. It also coordinates and collaborates with other agencies within HHS (e.g., the Office of Women’s Health, the Centers for Disease Control and Prevention [CDC], the Office of Minority Health); oversees and monitors grants and contracts that are national or cross-regional in scope (e.g., training grants regarding male family planning and reproduc- tive health with the University of North Carolina, clinical training with the University of Missouri, and the National Training Center with Cicatelli Associates; research; and the OPA Clearinghouse); responds to requests for   esearch grants and contracts may be used for research in biomedical, contraceptive devel- R opment, behavioral, and program implementation fields related to family planning. Research projects involve data analysis and related research and evaluation on issues of interest to the family planning field, as well as research on specific topics related to service delivery improve- ment. OFP has a standing announcement for service delivery improvement research, which encompasses quality of care, including the effectiveness, efficiency, timeliness, and equity of family planning services; reproductive health care of adolescents; reproductive health care of

PROGRAM MANAGEMENT AND ADMINISTRATION 103 FIGURE 4-1  Public health service regions. SOURCE: OPA, 2008b. Figure 6-1 bitmap image information; and provides leadership and direction for the Regional Offices that oversee family planning grants. In each of the Public Health Service Regions (see Figure 4-1), a Regional Health Administrator (RHA) is authorized to oversee the Title X program at the regional level through a memorandum of understanding (MOU) with the Central Office. The Central Office provides additional information and guidance to the Regional Offices through monthly conference calls and ongoing e-mail and telephone communication. It has developed an array males; family planning services to couples; organizational approaches to integrated services; translation of research into practice; increasing costs and their impact; and the effectiveness of Title X informational and educational activities. In addition to research covered by the standing announcement, research is currently being conducted through cooperative agreements with three grantees to analyze data on family planning needs and services over time using well- established formulas and databases; develop tools to assess and improve the quality of care in family planning clinics based on clinic data collection by a network of service providers; and analyze an array of national survey data sets to better understand the determinants of unintended pregnancy and childbearing. The RHA also oversees other HHS programs with a similar decentralized structure, such as those of the Office of Women’s Health.

104 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM of Internet-based communication resources. Each Regional Office is also assigned a liaison at the Central Office who serves as a point of contact for any questions or issues. Under the RHA, a Regional Program Consultant (RPC) carries out day-to-day program management and relationships with grantees, assisted by the regional family planning staff. The RPC selects grantees for family planning services and regional training, subject to RHA and OFP approval, oversees and monitors their performance, and is the liaison between OFP and grantees, as discussed more fully below. Grantee agencies, which are selected through a competitive process delineated in 42 CFR 59 and The Program Guidelines for Project Grants for Family Planning Services (OFP, 2001; see Appendix D), are responsible for delivering family planning services and developing networks of care. Grantees have legal and financial responsibility and accountability for the funds awarded and for the performance of the activities approved for fund- ing (OFP, 2001). Grantees may offer services directly and/or contract with delegate agencies to provide services under a negotiated, written agreement (OFP, 2001). Delegate agencies for family planning services must be appropriately licensed health care facilities that agree to provide services in accordance with Title X guidelines and applicable federal, state, and local laws; report data for the Family Planning Annual Report (FPAR); maximize third-party revenue (e.g., Medicaid); and participate in site visits by the grantee and the Regional Office. If services are provided by a delegate agency, grantees are responsible for monitoring the quality, cost, accessibility, acceptability, and perfor- mance of the services provided under the grant to ensure compliance with Title X guidelines; making sure that required data and other reports are provided; and reviewing and approving delegates’ informational and edu- cational materials. Grantees and delegate agencies can operate one or more c ­ linics and provide services other than family planning (e.g., general medi- cal or prenatal care), although these other services are not funded by Title X (see The Lewin Group, 2009 [Appendix J], Figure J-1 and Table J-1, for the organizational structure of the Title X program and a summary of the responsibilities at each management level). In 2006 (the last year for which national data are currently available), 88 grantees and 4,480 clinic sites offered Title X family planning services,   Each region manages one General Training and Technical Assistance grant, with grantees selected through a competitive process. In some regions, grantees are public or private ­entities that focus exclusively on training and education or training centers developed within the orga- nizational structure of a Title X services grantee (e.g., Center for Health Training—Region IX and Family Planning Council of Southeast Pennsylvania—Region III).   For a listing of the grantees, see the 2007–2008 Directory (OPA, 2008a).

PROGRAM MANAGEMENT AND ADMINISTRATION 105 operating in nearly 75 percent of the counties in the United States (RTI International, 2008). Clinics that received Title X funding provided services to almost 5 million clients in that year (RTI International, 2008). application process Grantee Requirements The Title X statutory language, regulations, and Program Guidelines establish the requirements for entities to become grantees. By statute, public or nonprofit private entities can receive grants or contracts to offer fam- ily planning services, provide training, conduct research, and develop and distribute informational and educational materials. Providers of family planning services must offer a “broad range of acceptable and effective medically approved family planning methods” and provide services without coercion and “in a manner which protects the dignity of the individual” (42 CFR § 59.5 [a]). If a clinic offers only a single method or an “unduly limited number” of methods, it cannot receive a grant but can participate as a delegate agency in a project (an activity supported by Title X funds) that offers a broad range of services (Program Guidelines, section 3.1). Projects that receive funds must provide for speci- fied medical and social services, informational and educational programs, and training for personnel, as well as coordination with and referral to other health care providers (42 CFR § 59.5 [b]). (See the discussion below regarding services provided.) Before applying for Title X funding, potential grantees must assess the need for family planning services in the service area. They must provide data regarding the population in need of the services, maternal and infant health statistics, barriers to care, existing services, and the need for addi- tional services to meet community/cultural needs, as well as identify the high-priority populations and target areas for the services to be offered (OFP, 2001). Grantee Selection As noted above, grantees are selected through a competitive bidding process, in accordance with HHS objective review procedures. The Pro-   HS H objective review is the Department’s formal review and evaluation process: “an ini- tial screening of an application is conducted to ensure it provides adequate information and complies with the requirements set forth in the agency’s funding opportunity announcement. After the initial screening is complete, the application is submitted to an ad hoc independent panel of peers or experts, a standing review committee, or a group of field readers for review in accordance with the evaluation criteria included in the funding opportunity announcement.

106 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM gram Guidelines specify that applications must include a needs assess- ment; a narrative description of the project and how the applicant intends to conduct it; a budget and justification for requested funds; standards and qualifications for personnel and facilities; project objectives that are “specific, realistic and measurable”; and “other pertinent information as required” (OFP, 2001, p. 4). To invite applications, OPA publishes Notices of Availability of Funds delineating these basic requirements, as well as additional information regarding priorities and issues that applicants should consider and evalua- tion criteria. The notices are published online at www.grants.gov. Applications for service grants are submitted to the Office of Grants Management for Family Planning Services at the Central Office, but appli- cations are reviewed and decisions made about the awarding of grants, their duration, and their amount at the regional level. The region’s Objective Review Committee (ORC) evaluates applications according to the follow- ing criteria in the Title X statute: • Whether the project plan provides for requirements set forth in Title X regulations (maximum 20 points) • Extent to which services are needed locally (maximum 20 points) • Adequacy of facilities and staff (maximum 20 points) • Capacity to make rapid and effective use of federal assistance (maximum 10 points) • Need of applicant (maximum 5 points) • Availability of other, nonfederal resources within the community (maximum 10 points) • Number of patients and number of low-income patients (maximum 15 points) The same scoring methodology is used by all 10 regional ORCs, but there are differences in how the above criteria are applied and used in fund- ing decisions. While applications are reviewed using the ORC process, competition rarely occurs among grantees since there are few applications for any given award, and there is almost no grantee turnover (less than 2 percent per year). However, according to OFP, there is more competition currently than in the past. As discussed more fully below, 57 percent of grantees are governmental (state or territory departments of health), and 43 percent The review groups are made up of qualified subject matter experts with in-depth knowledge of program issues directly relating to the agency’s mission. Once the application review is com- plete, written recommendations are provided to program management staff and the agency’s leadership, who make the final determination regarding funding” (HHS, 2006).

PROGRAM MANAGEMENT AND ADMINISTRATION 107 are nongovernmental entities that have been providing services for several decades (RTI International, 2008). Most regions have added or replaced, on average, one to two new grantees over the past 10 years (The Lewin Group, 2009). Once the ORC review process has been completed, the RHA and RPC determine the duration of the grant and the amount of funding. Grantee Funding Each region receives a core allocation of regular service funds by the Central Office, based on a historical formula that measures each region’s need according to three data sets—the Guttmacher Institute’s Women in Need of Contraceptive Services and Supplies (hereafter referred to as Women in Need) (Guttmacher Institute, 2008b), census data, and the Bureau of Primary Care’s Common Reporting Requirements. The Lewin Group notes that precise information is unavailable on the formula and weighting of each data set (The Lewin Group, 2009). In the early 1980s, the Central Office considered changing the regional allocations, but Congress included in its appropriations bill language that prevented such changes (see discussion, Methodology for Allocating Regu- lar Service Funds, Appendix J). Since then, both the regular service funds and any subsequent budget increases have been allotted to each region according to its established percentage. In 2003–2004, OFP, at the request of the Acting Assistant Secretary of Health, reexamined its methodology for regional allocations (The Lewin Group, 2009). At that time, OFP determined that the allocations continued to reflect the need in each region accurately. No further efforts have been initiated to evaluate or change the basic funding formula. The RHA and RPC have discretion to determine how funds will be distributed to grantees within their region. While they set forth a meth- odology for distribution of funds in the annual regional work plan, The Lewin Group (2009) reports that most methodologies were established some time ago and are used infrequently, as most grantees remain the same from year to year. It is only when a new grantee is added to a region that the methodology may be used. In all the regions examined by The Lewin Group, awards were based on the ORC score, the FPAR, and Women in Need. However, the regions varied in the weight they gave   he T HHS Bureau of Primary Care’s Common Reporting Requirements are the guidelines for annual reporting designed for community health centers. These requirements also were used as the guidelines for reporting on Title X until 1995, when the FPAR was instituted (The Lewin Group, 2009 [see Appendix J]).

108 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM to these data, and some grants were based largely on past awards to the grantees. According to the testimony of Title X grantees before the committee, grantees are largely unaware of how funding allocations are determined and are concerned about the lack of transparency, inequities in the alloca- tions, and the data that are used. In testimony provided during one of the committee’s public workshops, for example, a participant indicated that the distribution of funds in one of the Title X regions resulted in payments of less than $50 per user to some grantees and more than $200 per user to other grantees. The participant stated that “some degree of variation is both expected and appropriate, but a large discrepancy is not warranted,” and that allocations appear to be influenced by political considerations. Another example cited is that one grantee may have two clinics and receive $400,000, while another grantee in the same region may support 140 clinics and receive $2.1 million. The Lewin Group (2009) notes grantee concerns about the lack of adjustment for population shifts and the limitations of bas- ing allocations on data from Women in Need rather than on the number of people being served. These discrepancies lead grantees to believe that good performance is not being incentivized appropriately because some groups are receiving more money for serving fewer clients. (Such discrepancies may reflect geographic distribution, as it is more expensive to operate clinics in more remote areas. They may also reflect patient populations with differ- ent needs; for example, a homeless woman who uses drugs may require more and more expensive services than a 25-year-old married woman who is seeking contraception. However, data do not exist to support these or other explanations.) Greater transparency is also needed as to the criteria for determining the length of a grant (The Lewin Group, 2009). In addition to regular service funds, grantees receive supplemental expansion funds, regional priority funds, directed supplements, other exter- nal funding for targeted programs, and special project funds. These funds   he T Lewin Group reports that one region makes decisions on the allocation of regular service funds based on performance (using FPAR data [e.g., numbers of users, HIV tests, Pap tests] and grantee quarterly reports); a historical formula to assess the needs of the community (e.g., Women in Need, state and federal health statistics, needs assessments, National Survey of Family Growth); the number of Title X program users and the size of the grantee; and the resources and history of the grantee in the Title X program. Another region uses a more math- ematical methodology for calculating regular service fund grants (or regional project priority funds) (50 percent of funding is based on the grantee’s immediate past award, 30 percent on the number of women served previously who are at 100 percent of the federal poverty level and below [FPAR data], and 20 percent on Women in Need). A third region makes decisions about allocations by reviewing FPAR data on the clients/populations being served, the ORC score, the grant application plan, and the income level of the population served. Its decision- making process is more subjective. A fourth region simply allocates 90–100 percent of the immediate past award to the grantee (The Lewin Group, 2009 [see Appendix J]).

PROGRAM MANAGEMENT AND ADMINISTRATION 109 are allocated separately, using both competitive and other methods, and are awarded at different times during the year from regular service funds. Based on its proposal and the amount of the final award, a grantee determines the delegate agencies and clinic locations and how much fund- ing will be made available to each to ensure the best access geographically and by population. The Lewin Group (2009) reports that some grantees use the annual needs assessment to identify areas with an unmet need for family planning services, but that there is significant variability in the methodology used by grantees in distributing funds to delegates. Although most grantees pay delegates/clinics a standard base amount for basic costs plus a per patient rate, there is wide variation in those base amounts. The Lewin Group cites the examples of one grantee whose base amount is $80,000 and another whose base amount is $5,000, although these varia- tions may reflect numbers of clients served. The percentage of the previous year’s funding that is guaranteed by grantees also varies considerably. The Lewin Group provides examples of the different methodologies employed by Title X grantees (see Box 4-1). The Lewin Group reports that in recent years, many delegates have attempted to simplify their methodologies for allocating grants to ­delegates/ clinics. One means used was to include a per patient calculation in the formula. The Lewin Group notes that even delegates and clinics that experienced a loss of funds under a new methodology were supportive of the change because it introduced greater transparency and fairness into the allocation process and helped confirm that the right clients were being served. Grantees and Delegates: TypeS and Distribution Grantees vary by state and include governmental entities (state, local, and territorial health departments), as well as nongovernmental entities, including hospitals, university health centers, nonprofit organizations (such as Planned Parenthood affiliates and faith-based organizations), community health centers (CHCs) of various types, independent clinics, and other federally qualified health centers (FQHCs). Some states have only govern­mental grantees (e.g., Virginia, Colorado), some have only non­governmental grantees (e.g., Pennsylvania, California), and others have a mix of the two (e.g., New York, New Jersey).   QHCs include all organizations receiving grants under Section 330 of the Public Health F Service Act (e.g., CHCs, migrant health centers, health care for the homeless programs, and public housing primary care programs), certain tribal organizations, and FQHC look-alikes.   or a list of grantees and delegates, visit www.hhs.gov/opa/familyplanning/grantees/­services/ F fpdirectory07.pdf.

110 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM BOX 4-1  Examples of Methodologies Used by Grantees to Distribute Funds to Delegates Grantee A Grantee B • Standard base of $500,000 paid • Women in Need (weighted 10%) to delegate agencies for basic • Previous allocation (all health costs districts have been receiving money almost since the plus beginning) (weighted 50%) • 3-year case load (numbers) • Per client allocation based on (weighted 40%) number of non-Medicaid patients • Also apply 10% variability to seen in the previous year accommodate shifts in case load Grantee C Grantee D • Allocate more funding to agencies • 75% of funding is maintained (no serving higher numbers of delegate will lose more than 25% uninsured, low-income teen­agers of funding; none one can increase (less than 135% of the federal funding by more than 33%) poverty level) • Base starting amount is $80,000 • Take into account all of a • Take into account: program’s income from fees and — Number of users public and private insurance — Number of warning letters • Set goals for how much money (compliance) agencies should be generating — Number of special or used in the previous year, populations served whichever is higher — Number of adolescents under • Use the per patient rate for age 17 served allocations based on the number — Chlamydia screenings (e.g., of patients expected to be seen aligned with CDC guideline) and those actually seen (e.g., if a clinic is budgeted for $100,000 to see 1,000 patients, it is paid $100 for every patient seen; if it ends up seeing fewer patients, it owes money back; if it sees more patients, the grantee owes it money) SOURCE: The Lewin Group, 2009.

PROGRAM MANAGEMENT AND ADMINISTRATION 111 350.0 Actual Dollars 300.0 Constant Dollars 250.0 Millions of Dollars 200.0 150.0 100.0 50.0 0.0 19 0 19 1 19 2 19 3 84 19 5 19 6 19 7 19 8 19 9 19 0 91 19 2 19 3 94 19 5 19 6 97 19 8 20 9 20 0 20 1 20 2 03 20 4 20 5 06 20 7 20 8 09 8 8 8 8 8 8 8 8 8 9 9 9 9 9 9 9 0 0 0 0 0 0 0 19 19 19 19 19 20 20 FIGURE 4-2  Estimated funding for Title X when adjusted for inflation, FY 1980–2009. New S-1 and 4-2 SOURCE: Sonfield, 2009. Reprinted with permission from unpublished tabulations from the Guttmacher Institute. The number and distribution of grantees by type have changed sig- nificantly since the inception of the Title X program. In the 1980s, many HHS programs became block grants to the states. Although Title X did not become a block grant itself, funding was reduced (by approximately 23 percent in 1982; see Figure 4-2), and grant applications from state health departments received priority consideration. This shift resulted in a decrease in the number of grantees from more than 400 to less than 100, the majority of which were state grantees.10 In 2006, 57 percent of grantees were governmental (state, local, or territorial departments of health), and 43 percent were nongovernmental (RTI International, 2008). As noted earlier, some grantees provide family planning services them- selves, but most contract with delegates in whole or in part. The delegates of state health department grantees may all be governmental entities, such as local health departments (e.g., Virginia), or they may be a mix of governmental and nongovernmental organizations. Non­governmental del- egates (of governmental and nongovernmental grantees) include ­hospitals, university medical centers, community action programs, CHCs, school health programs, and nursing service organizations. Some delegates pro- vide only family planning–related services, while others offer a wider range of health care services. Some focus on particular client popula- 10  For example, the state department of health became the single grantee for the state of Texas in 1982, and 38 previous grantee organizations became delegates of that state agency, which at the time was not a direct provider of family planning services.

112 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM tions (e.g., teens, specific minority groups), while others serve broader populations. As noted above, most current grantees have been Title X grantees for many years. Most of the state health departments that emerged as grantees from the consolidation of grants at the state level in the early 1980s have remained in that role. Among nongovernmental organizations, grantees are often refunded through many cycles. They have demonstrated understand- ing of the needs of the geographic area to be served, success in developing networks of care and serving patients in their communities, the interest and skills necessary to carry out the subcontracting required, and the ability to meet OFP standards in collecting data and monitoring the performance of delegates. Continuing with high-performing grantees ensures continuity in service delivery through a well-established and -functioning network. The lack of new applicants that characterizes most jurisdictions may relate to the numerous requirements that grantees must meet, including the infra- structure that must be provided; larger organizations that are able to man- age these requirements are more likely to enter the process (Dalton et al., 2005). According to OFP, new grantees are usually selected when a new area of unmet need is identified or when one grantee is folded into another. A grantee rarely chooses to withdraw from the program (this occurs just once every 3–4 years) or is defunded for poor performance. One of the key roles of grantees is to create networks of service deliv- ery that can best meet the needs of the populations to be served; as noted, they usually do so through delegates that run clinics. While delegates or clinic sites may change over time, for the most part the clinics remain stable and provide a regular source of care for their clients. However, there has been no evaluation of the potential barriers experienced by service providers who are not part of the present network of providers in apply- ing for inclusion. Despite almost no additional resources being provided, the Central Office recently encouraged grantees to increase their competition for del- egates. While some grantees engage in this process regularly, others do not. For example, state health department grantees whose only delegates are local health departments often argue that competition is unnecessary. Other grantees worry that, given the severely limited resources available, competition will cause delegates to drop out of the system when they reassess the cost/benefits of continuing as a Title X provider. There is no one right answer as to whether asking grantees to engage in competition for delegates is beneficial or necessary; the decision should be based on the individual situation of each grantee in light of the best way to meet the needs of the target populations and maintain and improve access to care.

PROGRAM MANAGEMENT AND ADMINISTRATION 113 Services provided by grantees and delegates The Title X regulations establish services that grantees must provide, while the Program Guidelines, last updated in 2001, specify in detail what those services should include and how grantees must maintain their opera- tions (e.g., financial management; facilities and accessibility to services; personnel; training; reporting; the review of educational and informational materials; community participation, education, and project promotion; publications and inventions; and clinic management) (see also Chapter 3). The Program Guidelines apply to all clinical family planning services pro- vided by a recipient of Title X funds, even if services are not paid for by those funds and even if those funds represent only a small portion of a grantee’s or delegate’s budget (see the discussion below). The Program Guidelines set a high bar in defining a comprehensive family planning pro- gram and establishing standards of care. Mandated services include providing “clinical, informational, educa- tional, social and referral services relating to family planning to clients who want such services,” as well as “a broad range of acceptable and effective medically approved family planning methods and services on-site or by referral.” The Program Guidelines specify that “projects should make avail- able to clients all methods of contraception approved by the Federal Food and Drug Administration” (OFP, 2001, p. 13). Clinical Services Clinical services and their delivery are delineated in detail and include obtaining informed consent, taking a personal and family medical and social history, performing examinations and any necessary clinical proce- dures, conducting laboratory testing, performing follow-up, and making referrals. Specific provisions apply to fertility regulation, infertility services, pregnancy diagnosis and counseling, adolescent services, and identification of estrogen-exposed offspring, as well as related services such as gynecologi- cal services and screening and treatment for sexually transmitted diseases (STDs), including HIV/AIDS. The Program Guidelines specify what services in each of these areas should entail, along with some of the underlying reasons for their inclusion. Also delineated are specific services for females and males. Education, Counseling, and Outreach The Program Guidelines specify the provision of education and counsel- ing services (section 8.1-2) (OFP, 2001). In the area of education, a range of topics is to be covered, from information about family planning and contra­

114 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM ception to more general information regarding health screening, disease prevention (e.g., nutrition, exercise, smoking cessation), and reproductive anatomy and physiology. Counseling is required on the results of physical exams and laboratory studies; effective use of contraceptive ­methods and their benefits, efficacy, and possible side effects; return visits and emergency services; and STDs/HIV. The Program Guidelines require that education and counseling be documented in the client’s health record. The strong emphasis on education and counseling sets the Title X program apart from other public funding sources and is thought by many providers and commentators to contribute to better informed and more satisfied patients (Gold, 2007). Grantees and delegates (as well as educators, trainers, health care providers, and members of the public) can obtain educational materials free of charge from the OPA Clearinghouse, which collects, develops, and distributes publications on family planning, sexual health, and reproductive health. (The Clearinghouse also provides a database and directory of family planning grantees, delegates, and clinics, and provides referrals to clinics and government sources of information pertaining to family planning and related health issues.) The committee recognizes the value of educating and counseling clients. It is possible, however, that the numerous requirements in this area may be a hindrance to meeting the needs of individual clients. Clinics are required to provide education and counseling about all methods of contraception at every visit, even when a client already has a preference for a particular method or when certain methods are more appropriate than others given the informa- tion the client has provided about his or her circumstances. Moreover, exces- sive information may interfere with clients’ ability to understand or retain the information they need (Mayeaux et al., 1996; Safeer and Keenan, 2005) and imposes a burden on clinic staff, whose time is already limited. Educational materials used by Title X clinics must be approved by the grantee’s and delegate’s advisory committee before being distributed to ensure their suitability for the population or community and the purposes of Title X (42 USC § 300a-4(c), 42 CFR § 59.6). The review requirement applies to all materials, regardless of their source (including the OPA Clearinghouse) or their use by any other grantee. (See the discussion of this requirement in Chapter 3.) Educational requirements for Title X providers are not limited to pro- viding resources to patients. Title X clinics must also provide for “com- munity education programs . . . to enhance community understanding of the objectives of the project, make known the availability of services to potential clients, and encourage continued participation by persons to whom family planning may be beneficial” (OFP, 2001, p. 12). Several means are used to assess outreach and education activities. First, each delegate must set its own outreach and education targets in its annual

PROGRAM MANAGEMENT AND ADMINISTRATION 115 work plan, and reports actual performance to the grantee annually. The grantee conducts an annual site visit to each delegate at which the materials and records of the activities are reviewed. This information is also reviewed during the OPA Title X site visits. In addition, all of the materials used in outreach and education efforts are required to be reviewed and approved by the Information and Education Committee (see the section below on information and educational materials). The grantee and the OPA site visit teams review these committee minutes and the related materials during each site visit. In addition, many grantees regularly convene the leaders of outreach and education at each delegate agency to share experiences and discuss what is working. In terms of reporting to OPA, the annual reappli­ cations submitted by grantees contain progress reports from all delegates on their activities compared with their work plans, including the number and type of outreach and education activities. Considerable effort is made to evaluate the Title X outreach and education activities through atten- dance, the location of activities (to indicate target populations reached), and client satisfaction surveys. However, pre- and post-questionnaires to measure knowledge/attitude are used infrequently along with other quality measures, and there is some question as to whether the important educa- tion and outreach work of Title X is adequately captured in the program’s overall evaluation plan. Finding 4-1. There is a need to examine the adequacy and ease of use of tools that could be used by delegates to measure the quality of outreach and education efforts. OVERSIGHT OF GRANTEES AND DELEGATES Grantee performance is monitored by the Regional Offices through Comprehensive Program Reviews (CPRs) performed every 3 years, annual site visits, and the FPAR. The CPR evaluates the grantee’s financial, admin- istrative, educational, and clinical structure and activities, using the Pro- gram Review Tool. It is conducted by the RPC; other regional staff; and outside independent consultants with expertise in the clinical, administra- tive, financial, and community outreach and information components of the Title X program. Consultants are professionals with direct experience with Title X and may previously have served, for example, as nurses in Title X clinics or have worked for grantee or delegate agencies. In addition to visiting the grantee’s offices, the review team visits one to three delegate agencies and/or clinics overseen by the grantee (although grantees have primary responsibility for monitoring delegates and clinics). The annual site visit serves as a follow-up on areas identified for improvement. It is generally conducted by the RPC and also, in some cases,

116 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM by another staff member or one or more consultants if an outstanding issue relates to a consultant’s area of expertise (e.g., grant management, finance). Grantees also make annual site visits to monitor the performance of delegates. The FPAR is submitted by grantees, with input being provided by delegates as necessary regarding clients served and services provided (see Appendix G for the FPAR data elements). The report includes demographic, social, and economic characteristics of clients (including health insurance coverage and limited English proficiency); use of family planning methods; screening for cervical and breast cancer and STDs; utilization of family planning and related preventive health services; utilization of health per- sonnel; and revenues. The FPAR is the only source of uniform reporting by all grantees. There is wide variation in the methods used by grantees for data col- lection (The Lewin Group, 2009). Some grantees collect all data by hand. A few have developed their own electronic system with the assistance of the Central Office and the collaboration of all delegates and clinics. Several grantees prefer to contract with data service organizations. The data pro- vided by these reviews and reports and their adequacy for monitoring and assessing the program are addressed in Chapter 5. Grantees conduct a full needs assessment during their competitive application process (usually every 5 years) based on a very detailed compi- lation and analysis of community health and socioeconomic data. Examples of these data include a wide variety of health status indicators, birth rates, abortion rates, and public health insurance enrollment. The analysis is updated annually and helps inform decisions regarding priorities for the next year’s activities. Funding of Grantees and Delegates Congress has mandated that 90 percent of Title X appropriations be used to support Section 1001, the establishment and operation of volun- tary family planning programs. Thus in FY 2008/2009, $270 million of the $300 million appropriation will be used to support clinical services. As described above, those funds are distributed to the grantees, which may then distribute them to delegates. Title X funds represent only a portion of grantee and delegate budgets, and for some only a small fraction. Program regulations stipulate that “no grant may be made for an amount equal to 100 percent for the project’s estimated costs” (42 CFR §§ 59.7 (c)). Title X clinics may also receive funds from Medicaid, Maternal and Child Health (MCH) block grants (Title V of the Social Security Act, 42 USC § 501 et seq.), state and local appropria- tions, the State Children’s Health Insurance Program, Social Services block

PROGRAM MANAGEMENT AND ADMINISTRATION 117 State appropriations Maternal and Child Health (MCH) 13% block grant 3% Social Services block grant (SSBG) and Temporary Assistance for Needy Families (TANF) 2% Title X 12% Medicaid 70% FIGURE 4-3  Sources of public funding for family planning services, 2006. SOURCE: Sonfield et al., 2008a. Figure 6-3 grants, and Temporary Assistance for Needy Families (TANF)11 (see Figure 4-3). Most clinics also have patients who are covered by private insur- ance or who pay out of pocket for services,12 and some receive charitable donations. Non–Title X Family Planning Funding Sources Medicaid and Medicaid Waivers As noted earlier, while Title X remains the centerpiece of family plan- ning, funding for family planning services through the Medicaid program now exceeds that from Title X. The federal government pays 90 percent of each state’s Medicaid expenditures for family planning services and sup- 11  ocial S Services block grants, through Title XX of the Social Security Act, provide funds to state social services agencies to reduce individuals’ dependence on public assistance and can be spent for family planning services. TANF, which was created by the Welfare Reform Law of 1996 and became effective July 1, 1997, provides assistance and work opportunities to low-income families by granting states the funds and flexibility to develop and implement their own welfare programs. 12  ven though Title X was created to provide services to low-income women, services are E available to all, regardless of income.

118 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM plies and requires only a 10 percent match with state funds. In FY 2006, Medicaid funding for family planning services was estimated at $1.3 bil- lion for all health care provider settings (Sonfield et al., 2008a). Of this amount, Title X clinics alone received $320 million in Medicaid payments, slightly more than the $262 million allotted in Title X grant funds (RTI International, 2008). As discussed in Chapter 2, in 1993, the Medicaid Waiver program was instituted to allow states to waive normal Medicaid eligibility requirements to cover family planning services for those low-income individuals who otherwise would not qualify. To date, 27 states have implemented some form of the Waiver program (Guttmacher Institute, 2009). A 2003 federally funded evaluation of the Medicaid Waiver program in six states reported significant cost savings to both the federal and state governments (Gold, 2004). Moreover, a 2006 study estimated that, if the Waiver program were implemented nationally, federal and state savings of $1.5 billion annually would be realized by the third year (Frost et al., 2006). In addition to its macro-level benefits, the Medicaid Waiver program has had a positive influence programmatically by enabling Title X grantees and providers to serve greater numbers of clients. Some stakeholders believe that Title X and the Medicaid Waiver program complement one another as a more comprehensive effort to serve those in greatest need (Gold, 2007). The Waiver program has provided a dependable source of revenue for ­ clinics, helping to ensure overhead. Without reimbursement from the Medicaid Waiver program, many Title X clinics would not be able to con- tinue operation given constant increases in the costs of staff and supplies. However, unlike Title X, the Waiver program has a strict set of require- ments and limits coverage to the core services that are needed to promote effective contraceptive use, rather than more comprehensive reproductive health (Sonfield et al., 2008b). Section 330 Section 330 of the Public Health Service Act governs the operation of FQHCs, such as CHCs, which provide a broad scope of primary and pre- ventive health care services, including reproductive health services (BPHC, 2008b). CHCs are private, nonprofit, community-based health centers located in high-need or medically underserved areas that function as major safety-net providers for low-income and/or uninsured Americans. More than 1,000 CHCs operate more than 6,000 delivery sites in all states, ter- ritories, and the District of Columbia. Since 2000, federal investments in CHCs, most often by the Bureau of Primary Health Care (BPHC) at HHS, have doubled to more than $2 billion today (BPHC, 2008c). BPHC funding of family planning services was estimated at $5.8 million in FY 2006 (RTI

PROGRAM MANAGEMENT AND ADMINISTRATION 119 International, 2008). By law, CHCs are required to offer prenatal care, screening for breast and cervical cancer, voluntary family planning, and other basic services provided by an obstetrician or gynecologist. In 2007, 95 percent of CHCs provided family planning services. Some CHCs receive Title X funding to supplement their budget for reproductive health services. However, CHCs operate according to an independent set of requirements, some of which do not fit well with Title X. Maternal and Child Health and Social Service Block Grants The MCH (Title V of the Social Security Act) and Social Services (Title XX of the Social Security Act) federal block grants are provided directly to and controlled by state governments. MCH grants typically go to state departments of health, while Social Services grants go to state social services agencies (Sonfield et al., 2008a). Federal law permits states to use both grants for family planning services. However, in using MCH block grant funding, states are required by law to contribute 3 state dollars for every 4 federal dollars; there are no such requirements for Social Services funds. In FY 2006, MCH and Social Services block grants provided close to $23 million and more than $28 million, respectively, for family planning services (RTI International, 2008). Although traditionally, family planning was an important part of the MCH block grant program’s overall mission, the federal government has encouraged state MCH programs to move away from supporting direct patient care, including that for family planning (Gold and Sonfield, 1999). Most states now use MCH grants to fund population-based services (e.g., surveillance, immunizations) or program infrastructure. In contrast, the Social Services block grant program has tremendous flexibility to provide support across the spectrum of social services pro- grams (Gold and Sonfield, 1999). In the past, family planning was the only medical service for which it was applied as a supplement to other funding. However, severe budget cuts in the mid-1990s left the program financially crippled, and as a result, most clinics receiving Title X funding no longer receive Title XX funds. In some states, funding lost from the Social Services grant cuts was replaced by TANF grants (also provided directly to states) used to administer the state’s welfare programs. Simi- lar to Social Services grants, TANF funds could be used to supplement funding of family planning programs. However, TANF requirements are quite stringent, and many grantees therefore eliminated use of the grants for their family planning programs. In fact, none of the Title X grantees currently receive Social Services or TANF funds. For family planning ser- vices overall, TANF grants amounted to $10.5 million in FY 2006 (RTI International, 2008).

120 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM State Funding Some states provide limited funding for family planning activities through state appropriations outside the context of Medicaid or the block grants. Specifically, many states’ Medicaid agencies use state appropriations to provide medical services, including contraceptive services, to people who do not meet Medicaid eligibility criteria (e.g., certain immigrants). One study estimated that in 2006 independent state appropriations for family planning services reached $241 million (Sonfield et al., 2008a). Five states (California, Florida, New York, North Carolina, and Oklahoma) accounted for 57 percent of all state appropriations. For example, in addition to federal Title X funding, New York State has two programs for family planning services. The Family Planning Benefit Program covers family planning services for low-income citizens and those with satisfactory immigration status (SIS). The Family Planning Extension Program covers services for women losing their Medicaid coverage after a pregnancy. This program provides 2 years of family planning coverage for low-income citizens and those with SIS. Using state-only funds, the Family Planning Extension Program provides family planning for undocumented women, but only during the postpartum period. No other state has a comprehensive plan to provide family planning services to undocumented women with state-only funding. Some clinics also receive limited funding from local governments. In states with Waiver programs, some Title X grantees believe that county or local support was better prior to the program’s implementation. After its implementation, many local governments cut supplemental budgets based on the perception that clinics had sufficient funding with the new federal dollars, forgetting two important facts: (1) clinics are serving more clients because of the Waiver program; and (2) the Waiver program does not ­reimburse clinics for 100 percent of costs, especially when a visit goes beyond use of contraception. Generally, state appropriations account for at least 10 percent of all family planning funding in 20 states. It is important to note that, for close to 30 years (since 1980), state appropriations for family planning services have remained flat. Summary In summary, Medicaid now pays for approximately 70 percent of pub- licly funded family planning services, with Title X accounting for approxi- mately 12 percent, state and local governmental funds 13 percent, MCH block grants 2 percent, and Social Services block grants and TANF 3 percent (Guttmacher Institute, 2008a) (see Figure 4-3). Yet while Title X

PROGRAM MANAGEMENT AND ADMINISTRATION 121 represents a small proportion of public funding for family planning services, it plays a unique role. It covers services that other payers do not, clients who do not qualify for other coverage and cannot afford services, and expenses associated with program development and service delivery that other sources do not pay for directly. Providers mentioned these benefits of the program repeatedly during the committee’s site visits. Title X Funding Additional Services Covered by Title X Clinics receive most of their non–Title X funds through fee-for-service reimbursement programs that pay only for specific clinical services. Title X funds are not subject to such limitations and can be used to cover additional clinical services,13 office staff, the provision of contraceptives and other pharmaceutical products, and client education and counseling that are not reimbursed by other sources. In this way, Title X can complement these other sources to ensure the full range of services and activities necessary to optimize outcomes for all clients. Title X also provides funds for grantees and delegates to carry out community education and outreach and other activities that meet local needs. Populations Covered by Title X With Title X funds, clinics are able to provide reproductive health care services to people who otherwise would be unable to access or afford them. These include people who do not qualify for government-supported medical care (such as Medicaid, MCH, Social Services block grants, TANF), who lack insurance, or who face other legal or practical impediments to obtaining care. Critical to achieving the program’s goal of providing family plan- ning services to lower-income individuals is making those services avail- able at no cost to persons with incomes up to 100 percent of the federal poverty level and at discounted prices to those whose income is less than 250 percent of that level (42 CFR § 59.5(a)(8)). In most states, eligibility for publicly funded health care programs for adults, such as Medicaid, requires significant documentation14 and income limits are set much lower than 250 percent of the poverty level. The median U.S. income eligibility threshold for unemployed parents, for example, is 41 percent of the federal 13  xamples are treatment of STDs or urinary tract infections, which is not included in the E Medicaid family planning expansion in some states. 14Medicaid established new documentation requirements in 2006.

122 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM poverty level, while the median threshold is 68 percent for working parents (The Henry J. Kaiser Family Foundation, 2009). As increasing numbers of people lack health insurance (see Chapter 2), Title X clinics also provide access to family planning services for those who may not be at the lowest income levels but are unable to afford health care. Because of the relative openness of the program to low-income indi­viduals as compared with the other sources and providers of family planning services, RPCs and grantees reported that access to family planning and annual screening for STDs are better in Title X clinics. (While the majority [67 percent] of clients of Title X clinics had family incomes at or below the federal poverty level15 in 2006, and 90 percent of clients were at or below 200 percent of that level [RTI International, 2008], the regulations stipulate that persons whose income exceeds 250 percent of the poverty level are to be charged “fees designed to recover the reasonable cost of providing services” [42 CFR §§ 59.5 (a)(8), (b)(5)].) Eligibility for Title X funding also requires that services be provided without respect to ”religion, race, color, national origin, handicapping condition, age, sex, number of pregnancies, or marital status” (42 CFR § 59.5(a)(4)). Title X clinics therefore meet the reproductive health care needs of adolescents, men, recent legal immigrants, and the undocu- mented,16 who might otherwise forego family planning services. The provision of services to adolescents is a particularly important aspect of Title X. Most teens have limited knowledge of health care ser- vices, and many will not seek their parents’ involvement when they want to obtain contraception. They are also likely to seek care only when they feel that their confidentiality will be protected (Ford et al., 2004; English and Ford, 2007). By ensuring confidentiality and not requiring parental consent (although minors must be encouraged to involve their parents), Title X ­ clinics play a special role in providing care for adolescents. The clinic services also are especially suited to the special needs of adolescents. Most teens lack basic information about their health in general and repro- ductive health and birth control in particular, and many do not receive this information in their schools. The education and counseling provided by Title X clinics fill this important gap. In one-on-one encounters at Title X clinics, teens receive information they do not receive elsewhere. Because Title X personnel are sensitive to issues affecting teens’ attitudes and influ- ences on their sexual behavior (including their level of sexual experience, possible early childhood sexual exposure or abuse, and peer pressure), they 15  n 2009, the federal poverty level for the 48 contiguous states and the District of Columbia I was $10,830 for a family of one and $22,050 for a family of four. 16  egal immigrants are not eligible for Medicaid for their first 5 years of residency. L

PROGRAM MANAGEMENT AND ADMINISTRATION 123 can effectively discuss issues facing these young patients and spend more time with them than providers in other settings. Other Expenses Covered by Title X Title X grants are not limited to specific expenses but allow recipients flexibility to pay for overhead and infrastructure (facilities, equipment, information technology), staffing and staff training, supplies, and costs associated with needs assessments and reporting. This support is critical to keeping the clinics functioning and to meeting patients’ needs. The area of staffing is particularly important. Title X has covered not only medical staff, but also educators, social workers, staff with expertise in providing culturally and linguistically appropriate services, and staff who can work outside of normal business hours so that clinics can be open in the evenings or on weekends. Finding 4-2. While family planning services are funded through a variety of sources, which may vary from state to state, Title X plays a special role by covering services that other payers do not, clients who do not qualify for other coverage and cannot afford services, infrastructure, and expenses associated with program development and service delivery that other sources do not reimburse. Assessment of the Program’s Management and Administration This section provides the committee’s assessment of the strengths and weaknesses of the Title X program’s management and administration, and challenges faced by the program in providing services to its target populations. Central and Regional Offices: Structure and Relationships As discussed earlier, the Central Office establishes the framework for the Title X program, its policies, and its priorities. Although Regional Office staff expressed concern about the frequent changes in OPA leadership (see Chapter 3), grantees view the senior OFP staff as dedicated and experi- enced, with both substantive knowledge of family planning service delivery and institutional memory regarding program operations and requirements. The OFP staff have provided a high degree of continuity and stability for the program, and regional staff regard them as responsive, communicative, and supportive (The Lewin Group, 2009). RHAs/RPCs value their regular communications with the Central Office by e-mail and telephone, although

124 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM grantees reported that more written guidance would be helpful. Reliance on verbal communication has sometimes resulted in confusion or additional time required to obtain clarification (The Lewin Group, 2009). In addition to the senior professional staff, each Regional Office is assigned a liaison at the Central Office who serves as the first point of contact for any questions or issues. These liaisons vary in their level of experience with and knowledge of the Title X program, and this can affect their ability to assist their respective Regional Offices (The Lewin Group, 2009). Regional Offices and Grantees: Structure and Relationships Staff and participants at the federal, regional, and state levels generally view the decentralized, regional structure of the Title X program as benefi- cial. It allows program administration to be responsive to local conditions and the specific needs of communities (including differences in popula- tions and cultures); strengths, needs, and weaknesses of grantees; and state political climates. The program structure also allows for the development of training that addresses the needs of regional staff. The relationship dynamic between RPCs and grantees varies widely among regions. According to The Lewin Group (2009), many grantees find their relationship with their RPC to be positive and transparent. Regu- lar communication is maintained, and the RPCs serve as communication sources of programmatic and financial information. Other grantees perceive less openness in their relationship with their RPC. Communication is less frequent, and grantees believe their messages to the Central Office are diluted, and that their RPC does not advocate adequately for them. Attention from the Central Office to problems of grantees and RPCs is also inconsistent. The RPCs discuss problems and other issues among themselves (often during a conference call prior to their monthly conference call with the Central Office). However, the issues raised fail to be resolved because the necessary leadership from the Central Office is not forthcoming (The Lewin Group, 2009). Placing most of the decision-making authority with the RPCs results in a number of inconsistencies in how policies and regulations are interpreted and audits and reviews are conducted.17 Regions also vary in the degree of 17  ndependent consultants, who, as noted earlier, often participate in the CPRs, do not I receive uniform training in carrying out these reviews. Therefore, they may differ in the way they interpret the Title X guidelines and grade grantees (e.g., how clinics should ask for c ­ lient donations, what increments are used on the sliding fee scale). According to The Lewin Group (2009), the result is inconsistencies in how grantees are evaluated, not only for that CPR, but also for their performance longitudinally and against other grantees regionally and nationally.

PROGRAM MANAGEMENT AND ADMINISTRATION 125 coordination with other programs (such as the Office of Minority Health and the Office of Women’s Health, both of which also are under the direc- tion of the RHA) (The Lewin Group, 2009). Finally, the level of expertise of regional staff varies. RPCs do not receive formal training for their posi- tion and differ in the extent of their experience with the delivery of family planning services. Finding 4-3. The regional system for managing and administer- ing the Title X program often serves varying needs across regions effectively and is an important function of the program, but there is room for improvement. Grantees and Delegates: Service Delivery The network of clinics supported by Title X delivers crucial family planning services for communities and populations that are underserved and would otherwise lack medical care. According to the 2002 National Survey of Family Growth, a Title X–supported clinic was the primary source of reproductive care for 9.6 percent of female respondents who obtained any sexual or reproductive health care service. A greater number, 12.8 percent, of women who received such a service obtained it primarily from a public clinic that received Title X funding (Frost, 2008). Interviews during the committee’s site visits revealed that clinic staff generally have both family planning expertise and dedication to the mission of Title X. Their knowledge of their communities enables them to develop and effectively deliver the range of services required by the Program Guide- lines in ways that meet local needs. They are also in a position to work with schools and other health and social service agencies in their localities to ensure that target populations are reached and that clients’ other needs are met. Finding 4-4. The network of clinics supported by Title X is a c ­ ritical part of the health care safety net in the United States. The available services, however, may not be able to meet all of the family planning needs of clients or meet them in a timely way. Some clinics cannot provide all the required Title X services in one visit. For example, during a site visit to a local health department that receives Title X funds, staff mentioned the need to refer patients to other facilities for HIV test- ing or have them return when such testing was being provided in the STD clinic. Some providers, particularly in rural areas, are not open on many or most days. Similarly, because of funding and staffing challenges (discussed more fully below), many clinics reported that they cannot offer services to

126 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM all who want them, and even if they can provide appointments, clients may have to wait longer than the 2 weeks stipulated by the Title X program. Challenges for Grantees Title X grantees face numerous challenges that impact their ability to provide services and that may be difficult to overcome because of the cur- rent management and administrative structure. These challenges relate to the following: • Overall funding limitations and rising costs • Management of multiple funding sources • Program guidelines • Procedural requirements • Communication • Staffing • Informational and educational materials • Challenges of serving populations that are the focus of Title X • Provision of culturally appropriate care • Provision of services that meet client needs Funding Limitations and Rising Costs As is true for much of the nation’s stressed health care system, funding for the Title X program is severely constrained. Shortly after the program was established, Congress dramatically expanded its funding, which ulti- mately peaked in constant dollars in 1980. Since then, however, funding has declined significantly (see Figure 4-2 earlier in this chapter). According to findings from surveys of Title X grantees, as well as testimony heard by the committee, funding and rising costs are by far the greatest challenges facing grantees and have been for many years (Sonfield et al., 2006). While fund- ing has increased in actual dollars, it has not kept pace with the increased costs for salaries and benefits, contraceptives and other pharmaceuticals, clinic supplies, laboratory tests, infrastructure (e.g., rent, utilities, informa- tion technology), or insurance, or with the increased numbers of people seeking services (Sonfield, 2009). Taking inflation into account, funding for Title X in constant dollars was 62 percent lower in FY 2008 than in FY 1980 (Sonfield, 2009). A 2005 survey of 14 Title X grantees revealed that their expenditures on contraceptive supplies increased by approximately 26 percent between 2001 and 2004, while their Title X grants increased by approximately 11 percent (Sonfield et al., 2006). As a result of rising prices, some clinics have created waiting lists for some contraceptive methods (AGI, 2000). A

PROGRAM MANAGEMENT AND ADMINISTRATION 127 small sample of Title X programs also reported that their expenditures on diagnostics more than doubled between 2001 and 2004 (Sonfield et al., 2006); however, there was notable variation in these expenditures among respondents, with some reporting decreases and others increases of 150 per- cent or more. Under the Program Guidelines, a Title X clinic must “main- tain an adequate supply and variety of drugs and devices to effectively manage the contraceptive needs of its clients” (OFP, 2001, p. 28). Clinics report that this is one of the strengths of the program (Gold, 2008), but that increased costs have limited the types of contraceptives available. While the shortfalls in funding have forced clinics to be more efficient and cut waste, the committee learned from its site visits and the testimony of grantees and delegates that they have also led to more limited clinic hours, the closing of clinic sites, reduced availability of certain (more expen- sive) types of contraceptives, reduced staffing, curtailed outreach efforts, and reduced community and clinic educational programs. New funds made available typically are directed at new mandates or increased numbers of users and cannot be used to address funding gaps in existing programs. As one clinic representative told committee members: The main problem with the program is that there are not enough funds. The problem was underscored this year when additional funds would be made available only if they were associated with an increased volume. Given that they were running very close to the bone this did not seem sensible. Finding 4-5. Title X has inadequate financial resources to pro- vide comprehensive care to patients and communities at a high level of professional standards or to exercise leadership in family planning. Many Title X clinics obtain contraceptive products through the Office of Pharmacy Affairs’ 340B drug pricing program18; consortia, cooperatives, or other groups of individual providers (such as Planned Parenthood); or state governments that negotiate discounted prices for bulk purchasing. According to the testimony of grantees, the ability to access less expen- sive contraceptives and other pharmaceuticals through the 340B program entices clinics to join and remain in the Title X program. 18  he T 340B drug pricing program, established in 1992, limits the cost of covered outpatient drugs to certain federal grantees (such as Title X grantees), FQHC look-alikes, and qualified disproportionate share hospitals (42 USC § 340B). Under the program, the Pharmacy Services Support Center and Prime Vendor Program assist eligible entities with information and techni- cal assistance and drug price negotiation services, respectively. Testimony of Ann P. Ferrero, HHS, HRSA, May 19, 2008.

128 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM While the 340B program does provide considerable cost savings, Title X clinics noted many problems in maintaining continuity of products because the program revises its list of available drugs quarterly and often obtains products with short expiration periods. One clinic representative noted that price fluctuations and frequent changes in the availability of certain drugs can lead to increases in the overall costs of providing services because clients must return to the clinic to change their prescription.19 Moreover, clients’ adher- ence and satisfaction may suffer if products or methods they prefer or with which they are familiar became unavailable (see Appendix F). The adminis- trative cost of contraceptive purchasing is also an issue for many grantees. For entities participating in the 340B program, for example, the quarterly revisions mean they must constantly monitor the list of available products. Costs also have prevented clinics from using the most advanced con- traceptives and diagnostics as they are almost always more expensive than older versions. For example, providers noted that the relatively high cost of intrauterine devices, Implanon, and other more modern contraceptives (for both the product and related clinic services) put these products out of reach for many clinics even though some clients prefer them, and they are more effective and reliable in the long term. For cervical cancer screening, many clinics are limited to regular Pap tests because of the higher cost of the newer liquid-based test, which reduces the number of tests that need to be repeated (ACS, 2006).20 The recently developed test for human papil- loma virus and the vaccine to prevent it likewise are too expensive for most grantees and delegates to provide. There are ways to purchase reduced-price drugs. For example, federal purchasing programs are used by the Department of Veterans Affairs and CDC (for the Vaccines for Children program and for diagnostics for HIV and chlamydia). Finding 4-6. The costs of drugs and diagnostics are high and ris- ing. The Title X program is not optimizing its leverage to contain these costs. Management of Multiple Funding Sources As discussed earlier, Title X clinics rely on funds from a number of sources, necessitating coordination and management of multiple funding sources at the federal, state, and local levels to operate a comprehensive 19  A product may become unavailable after just a few months since the list changes quarterly. 20  ccording to American Cancer Society guidelines, screening should be done every year A with the regular Pap test or every 2 years using the newer liquid-based Pap test.

PROGRAM MANAGEMENT AND ADMINISTRATION 129 reproductive health program. In general, grantees reported that they have found ways to make funding sources work together. They also reported that free-standing and private-sector clinics are perceived to face greater challenges in coordination of funding. The inclusion of a financial audit in the CPR provides adequate over- sight of the coordination and use of multiple funding sources. Financial consultants that serve on the review team evaluate accounting records and the management of funding. The consultants are regarded highly for their ability to identify issues (such as a grantee not funneling fee-for-service reimbursements back into the Title X program) and to provide construc- tive and educational guidance to grantees. From the standpoint of funding, RPCs and grantees identified no obvious areas of duplication or lack of coordination. Most coordination-related issues pertain to the differences among pro- grams’ operational requirements, which can affect access to care. Especially pronounced are the differences in requirements associated with program administration and clinical services among Title X, CHCs (under federal 330 rules), and the Medicaid Waiver program. RPCs and grantees see no need to have different rules for these three programs. Moreover, because Medicaid is a state-driven program, each state may implement different rules for use of the funds. For example, in Arizona, the Medicaid Waiver program is used to cover postpartum services (including sterilization ser- vices) for individuals at or below 100 percent of the federal poverty level. In California, the Medicaid Waiver program has been instituted with much broader application for those at 200 percent of the poverty level (Sonfield et al., 2008b). Because of these variations, Title X may serve different pur- poses in different states, adding to the complexity RPCs may experience in reviewing grant applications for their region. In general, the solution has been for RPCs to work closely with grantees to improve program manage- ment, but there is great need to better define strategies that can enhance program coordination to ensure that all funds are used most efficiently. While there is always uncertainty as to when appropriated funds will be available (because of frequent delays in passing appropriations bills before the start of the fiscal year), the Title X program could alleviate some administrative burden by better coordinating the funding cycles for various Title X funds (such as regular and supplemental expansion funds). Coordi- nating the many requirements for the multiple federal programs involved in the provision of family planning services could reduce the administrative burdens and costs borne by grantees and delegates. These requirements include sliding fee schedules; documentation related to income, residential address, and citizenship; verification of third-party insurance coverage; and reporting (see also the section on procedural requirements below and the section on coordination of Title X and other sources of funding for family

130 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM planning services in Appendix J). Additional factors posing administra- tive challenges include different state requirements for parental consent for treatment of minors, equity requirements (not every program pays for every service), restriction of services under the Medicaid Waiver program (individuals with third-party health insurance of any kind are disqualified from participation in the program, even if that insurance exempts coverage of family planning services [Sonfield et al., 2008b]), and limited access to c ­ ommunity-based providers for individuals covered under Medicaid man- aged care (see the above-referenced section in Appendix J). As the Centers for Medicare and Medicaid Services moves states toward the medical home model of care coordination among providers, it is unclear how family planning services will be affected. Some states, such as Iowa, are develop- ing collaborative networks of safety net providers, including CHCs, free clinics, rural health clinics, family planning agencies, maternal and child health clinics, and local departments of health, to ensure broad access to and coordination of care (Iowa Department of Public Health, 2008). While family planning services are an included benefit under Medicaid rules, other states may promote the use of primary care providers for such services. The Program Guidelines In specifying required medical services, the Program Guidelines state that for the physical assessment of a female, “an initial complete physical examination, including height and weight, examination of the thyroid, heart, lungs, extremities, breasts, abdomen, pelvis, and rectum should be performed” (OFP, 2001, p. 21). Clinics must also “provide and stress the importance of . . . blood pressure evaluation; breast exam; pelvic examina- tion; . . . pap smear; colo-rectal cancer screening in individuals over 40; and STD and HIV screening, as indicated” (OFP, 2001, p. 21). The Pro- gram Guidelines additionally require counseling regarding these preventive services and establish time frames for their provision. This broad range of services is mandated because “for many clients, family planning programs are their only continuing source of health information and clinical care” (OFP, 2001, p. 21). While this range of services is certainly important for the overall and long-term health of patients at various points in their lives, it goes beyond what is essential for effective family planning. For example, breast and colorectal cancer screening is valuable for early detection of these cancers, but these services are not an essential component of reproductive health care, especially for people early in their reproductive years. According to testimony heard by the committee (and discussed in Chapter 3), the breadth of the requirements in an environment of limited resources creates a ten-

PROGRAM MANAGEMENT AND ADMINISTRATION 131 sion between providing broad preventive care to fewer clients and offering targeted family planning services to a greater number. The Program Guidelines also include services that may not be appropri- ate for all clients and are not in accord with current professional clinical recommendations. The cancer screening requirements apply to all patients at a Title X clinic, regardless of age or risk factors. This means, for example, that adolescents seen at Title X clinics must have breast, rectum, and ­pelvic examinations and Pap smears within 6 months of becoming a patient, even though relevant abnormalities are rarely found in adolescents. Like- wise, the American College of Obstetricians and Gynecologists (ACOG) does not recommend cervical cytology screening for young women until approximately 3 years after initiation of sexual intercourse, but no later than age 21 (ACOG, 2006). Some Title X clinic staff expressed concern to the committee about this requirement; they believe that patients should not be required to have pelvic examinations before initiating hormonal methods as this requirement creates a barrier for some individuals. Other screenings prescribed in the Program Guidelines that are incon- sistent with professional clinical guidelines include yearly Pap tests for many adult women over age 30 and colorectal screening. ACOG recom- mends that for “women aged 30 years and older who have had three con- secutive negative cervical cytology screening test results and who have no history of cervical intraepithelial neoplasia (CIN) grade 2 or CIN 3, are not immunocompromised and are not HIV infected, and were not exposed to diethylstilbestrol in utero may extend the interval between cervical cytology examinations to every 2 to 3 years” (ACOG, 2003). Similarly, the American College of Physicians’ clinical guidelines for colorectal cancer screening and surveillance prescribe that “screening programs should begin by classifying the individual patient’s level of risk based on personal, family, and medi- cal history, which will determine the appropriate approach to screening in that person. Men and women at average risk should be offered screening for colorectal cancer and adenomatous polyps beginning at age 50 years” (Winawer et al., 2003). During the committee’s site visits and in workshop testimony, RPCs and grantees also noted that under the Program Guidelines, there is little room for regions or grantees to implement innovative approaches or to experi- ment with potential program improvements (see also The Lewin Group, 2009). Any deviations from the required services, including those stemming from service providers’ professional judgment, can result in negative com- ments during site visits and reviews. By not reviewing and updating the Program Guidelines for clinical, behavioral, and educational services to reflect the most current professional standards, OPA is creating a critical problem for health professionals in Title X clinics that represents a serious failing of the program. Providers are

132 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM being asked to choose between offering services that comply with the Pro- gram Guidelines and those that are best professional practices. The delay in adopting the most up-to-date standards means that the program not only fails to serve patients as well as it should, but also imposes unnecessary costs in some instances. Finding 4-7. Requirements outlined in the Program Guidelines include services that may not be appropriate for all clients and are not in accord with current evidence-based professional clinical recommendations. Some of the requirements go beyond what is essential for effective family planning. These unwarranted require- ments result in inefficient use of limited resources and may also deter individuals from seeking care. A possible policy direction is making the Title X guidelines (updated as the committee recommends) the standard used by all federal health programs, including the 330 program. The committee notes further that many Title X delegates (e.g., CHCs) provide comprehensive care and have other sources of income that should be used to pay for services beyond those essential for effective family planning. Likewise, Title X recipients that focus on providing family planning should develop networks to refer patients who have other health care needs. Procedural Requirements Procedural requirements of OPA and the other entities that govern the functioning of Title X grantees present additional administrative challenges. These include procedures for applications and allocations, program review, and reporting. The OPA requirements for proposals are the same for governmental and nongovernmental entities. As noted earlier, in many states the state health department is the sole grantee. Requiring them to use the same competitive bid process as that required for nongovernmental entities imposes undue costs on the state health departments and appears unnecessary given their defined roles and long-term participation in the program. State grantees have recommended that OPA consider different allocation processes for the different types of applicants. They have suggested that state agencies could provide a revised justification for renewed funding and that OPA could review a state’s performance during a project period to determine whether any funds were misspent and ensure that funds were received by the right delegates/clinics (The Lewin Group, 2009). Absent indications that a state health department is having problems delivering care, providing grants to state agencies for longer uniform periods (e.g., 5 years instead of the vari-

PROGRAM MANAGEMENT AND ADMINISTRATION 133 able 3–5 years) would also allow for better long-term planning and cost savings. Long-term nongovernmental grantees could make similar argu- ments. The committee believes a simplified application process for grantees demonstrating continued good performance would be beneficial, as would providing funding for longer periods. In light of the considerable stability of the service delivery network that has been created through Title X, these measures would reduce the administrative burden for all involved. Most Title X grantees must deal with multiple entities regarding pro- gram requirements, funding, licensing, and oversight. Inconsistencies in requirements add to the administrative burdens and costs faced by clinics. For example, when a delegate is an FQHC (330 program), there are differ- ent fee scales and different data collection requirements for Title X and the 330 program. These inconsistencies are burdensome for patients as well; for example, it appears that in certain situations, some women must sub- mit information so the clinic can check to see which funding source covers them, as well as which exams, requirements, and paperwork are necessary. The requirements of these programs could and should be coordinated. Communication Some grantees have found their relationship and communication with the Central and Regional Offices to be a source of frustration. While OFP communicates regularly by e‑mail and conference calls with RPCs, who in turn communicate with grantees, the process does not provide ­grantees with information they desire about program decisions. In addition, grantees do not believe that they have adequate input into such decisions or that their concerns reach the Central Office. This lack of transparency regarding decisions by the Central Office and RPCs is a major concern for grantees. Changes in service requirements and new priorities are announced without the grantees having an opportunity to offer their views or provide infor- mation about the impacts of the changes on current services. As noted previously, grantees also believe they are inadequately informed about how funding decisions are made. In addition, grantees and delegates reported that they would like more feedback on their performance on a regular basis and more constructive advice on how to improve. While the CPRs provide an opportunity for communication about performance, some grantees said the process would be more useful in improving their programs if it had a less detailed focus and if it were less punitive and more educational and supportive in nature (The Lewin Group, 2009). The FPAR and other information submitted to OFP can also provide a basis for feedback to grantees and delegates. However, OFP does not inform grantees about how their performance compares with that of others

134 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM or provide them with information on how other grantees have addressed problems they have encountered. Grantees would like more opportunities to learn from other grantees about successful program implementation approaches that might be replicated. Finding 4-8. There is a lack of transparency and communica- tion regarding how decisions affecting program requirements are made and how funding allocations and the duration of grants are determined. Staffing Staffing is a pressing concern for many grantees and delegates. It is likely to become even more so given the shortage of and competition for trained medical personnel in most areas of the country, as well as the impending retirement of many nurses and nurse practitioners who staff the clinics, the increasing cost of salaries and benefits, the need for and cost of continued professional training (Murray, 2002), and efforts to promote nursing training at the doctoral level (AACN, 2008). There has also been a trend toward increased training for entry into practice for nurse practitioners, who make up a significant proportion of medi- cal professionals. As with other professions (such as pharmacy, which now requires a “practice doctorate”), and on recommendations from the Institute of Medicine (2003), a “doctor of nursing practice” is slated to be the training requirement for new nurse practitioners by 2015. This requirement is expected to involve one additional year of training over the length of training for the current masters-prepared nurse practitioner. The enhanced skills gained through this training will benefit patients who rely on Title X services for much of their comprehensive health care by better equipping these clinicians with “interdisciplinary, information systems, quality improvement and patient safety expertise” (AACN, 2006, p. 5, 2008). At the same time, there are some unanswered questions about this additional training requirement, such as whether it will exacerbate short- ages in the available nurse practitioner workforce and how it might affect the cost of hiring nurse practitioners. The limited pool of qualified professionals has been an ongoing prob- lem for the Title X program.21 This problem will become greater with the 21  arlier, E Title X funded certificate Women’s Health Care Nurse Practitioner education programs located in geographically diverse regions (at Planned Parenthood in Philadelphia, Emory University Medical School in Atlanta, University of Texas Southwestern Medical School in Dallas, and Harbor UCLA in Los Angeles) to provide access for participants from Title X programs. These programs graduated more than 4,000 nurse practitioners. They closed in 2005 because of changes in licensing and accreditation, which mandated a masters degree in

PROGRAM MANAGEMENT AND ADMINISTRATION 135 growth in demand for Title X services, including services that can meet the needs of increasingly culturally and linguistically diverse populations (see the section on providing appropriate care below). Recruitment and retention is the most pressing concern. Most clini- cal care is provided by nurse practitioners who have advanced nursing training at the master’s level (CDC, 2004). In 2006, midlevel health care pro­viders, who include nurse practitioners, physician assistants, and certi- fied nurse midwives, made up 51 percent of the full-time medical staff at Title X–funded clinics (RTI International, 2008). As heard in testimony before the committee, those clinics compete for medical professionals with other types of health care organizations, but generally are not in a posi- tion to offer competitive salaries and benefits. The shortage of personnel is particularly acute in rural areas. The costs of recruiting and retaining staff who can address the needs of Title X clients, including those who can provide culturally appropriate care, have increased. In a 2001 Guttmacher investigation of 12 Title X clinics, respondents indicated that the demand for language assistance for clients with limited English proficiency increased their costs of doing business (Gold, 2003). According to the 2006 FPAR, such clients repre- sented 13 percent of Title X users (RTI International, 2008). Staff that can assist these clients are needed at every level of service, from intake to clinical encounters. However, increased competition, particularly for nurse practitioners, makes attracting these individuals to family planning clinics increasingly difficult. Finding 4-9. Title X is currently facing difficulties in recruiting and retaining staff who can meet the increasingly complex needs of diverse populations. These needs will grow in the future. Informational and Educational Materials During the committee’s site visits, in testimony provided by grantees and delegates, and in the Membership Survey of the National Family Planning and Reproductive Health Association (NFPRHA), several issues regarding informational and educational materials were raised. These issues include the manner in which materials developed by the OPA Clearinghouse are reviewed, the duplicative review by a delegate’s advisory committee after review by the grantee responsible for the delegate, and delays or nursing for nurse practitioners. Subsequently, OPA/Title X funded two programs—an online clinical specialty course designed to provide clinical competency–based family planning educa- tion for nurse practitioners (offered until 2006) and the current preceptorship program, which is offered through the National Clinical Training Grantee.

136 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM other problems in obtaining payment for materials ordered from outside sources. Grantees and delegates suggested that materials used in a related program might be distributed without additional review. Concerns were also expressed about the ability of the advisory committees (rather than professional health educators or public health personnel) to select cultur- ally, linguistically, and literacy level–appropriate materials. Grantees and delegates indicated that some of the OPA Clearinghouse materials fail to meet those criteria—deficits that should be rectified at the Clearinghouse level. Challenges of Serving Populations That Are the Focus of Title X With growth in the overall population and expected parallel growth in the low-income population, cutbacks and gaps in health insurance, the large number of adolescents with unmet needs for family planning services, increased prevalence of STDs, and other societal changes (discussed in Chapter 2), the demand for family planning services has increased. While funding is a core issue that affects the ability of Title X clinics to provide care for all who seek it, the situation poses particular challenges concerning the special needs of target populations such as adolescents, men, and people with limited English proficiency. Common to all of these groups is the need for specialized outreach to overcome barriers to their seeking clinic services. Grantees noted problems in meeting the costs of outreach and having staff available for the purpose given the personnel cutbacks resulting from lim- ited funds. One grantee interviewed during a site visit lamented the lack of funds for advertising or conducting studies to determine what works to bring people to the clinic. Some grantees and delegates have tried to reach target populations by developing partnerships with other social and human service providers or schools, but they would like to do more. Adolescents pose special problems because of their lack of knowledge about reproductive health and the services they might use. As discussed above, the Title X program provides education and counseling to address this deficiency and meet the needs of individual patients. If these ben- eficial services are to be made available, resources must be committed to ensure sufficient time for provider–patient sessions and appropriate staff training. Another challenge regarding the provision of services to adolescents is the required clinical examination, in particular the requirement that pro- viders perform a pelvic exam within 6 months of the patient’s first visit. As discussed above, grantees expressed concern that this requirement may deter teens from seeking services or continuing as clients. Under ACOG’s current guidelines, adolescents may make several gynecological visits before

PROGRAM MANAGEMENT AND ADMINISTRATION 137 they have an internal examination, during which time they may develop trust in the provider. The “ABC” approach to counseling for HIV prevention (Abstinence, Being faithful, and Condoms) is also viewed by some grantees as an impediment to the provision of services to adolescents. Respondents to the NFPRHA survey indicated that the ABC approach is unrealistic, noting the difficulty of providing effective counseling on abstinence to sexually active teens who are seeking contraceptives. ACOG takes a different approach, arguing that having a confidential discussion about the patient’s general health, dating relationships, and intimacy and sexual activity and encour- aging the sharing of information are important for providing appropriate health care to adolescents (ACOG, 2004). Many studies have found that, especially for teens, the most effec- tive approach to preventing unintended pregnancies is to address broader aspects of young people’s lives, such as their investments in education, civic service, and youth development. In a review of more than 150 studies, for example, researchers from Child Trends identified approaches that have had a positive impact on teenagers’ reproductive health behaviors. Among these approaches were those that combined sexuality education for older children with positive activities such as participating in voluntary community service and youth development programs (Manlove et al., 2002). Kirby (2007) found that comprehensive programs, which include education about delay- ing sexual activity and decreasing the number of sexual partners as well as information about contraception, were considerably more effective overall than those focused on abstinence-only education in encouraging positive reproductive health behaviors and showed no significant negative effects. In addition, many private foundations are investing in research aimed at identifying ways to improve the family planning and reproductive health care available to low-income women, including teens. Although men represent a small percentage of Title X clients (approxi- mately 5 percent), adolescent and young adult males are at particular risk for STDs and sexual activity that results in unintended pregnancies, and benefit from receiving formal instruction about birth control methods. Studies have shown that efforts to target this population can significantly improve knowledge of contraception, pregnancy risk, and sexual respon- sibility, which presumably leads in turn to positive reproductive health impacts for males and females (Danielson et al., 1990; Armstrong et al., 1999; Brindis et al., 2005). Efforts are under way at clinics around the country to explore means of reaching out to men in need of reproductive health services (Brindis et al., 1998). Yet Title X providers disagree about the emphasis the program should place on serving men, as opposed to focus- ing on the primary goal of meeting the contraceptive needs of women.

138 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM Provision of Culturally Appropriate Care Offering culturally and linguistically appropriate care and education raises many concerns for Title X clinics, ranging from providing medical care that is in accordance with a patient’s cultural norms to communicating effectively with patients who have limited English proficiency. The demand for assistance to clients in many languages is increasing in communities nationwide (Gold, 2003). Culturally sensitive interpreters can provide translation to ensure that adequate and essential communication takes place between a patient and his or her provider. Evidence indicates that using such trained interpreters not only improves communication but also increases patient satisfaction and health outcomes, while quality of care is compromised when needed interpreter services are not provided (Flores, 2005). As discussed in Chapter 3, HHS’s Guidance Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons also requires agencies that receive federal fund- ing from HHS to ensure that clients with limited English proficiency have access to services the agencies provide. However, the cost of providing such interpreters (or the alternative of “language lines”) is high if staff members are unable to speak the patients’ languages. Recruiting and retaining staff, including clinicians who can provide culturally and linguistically appro- priate care, is a continuing challenge. Grantees are concerned, too, that some of the Title X educational requirements may not account for cultural differences or language barriers (NFPRHA survey 4). Provision of Services That Meet Client Needs The Program Guidelines establish requirements for the package of ser- vices that all patients must receive. As discussed above, however, grantees are concerned that the requirements force them to offer too many unneces- sary and time-consuming services that patients may not want, and therefore do not allow them to individualize services to meet patients’ needs in line with scientifically based best practices. In the area of education and counsel- ing in particular, clinic personnel should have the flexibility to make deci- sions regarding issues to discuss, taking into account current evidence-based guidelines and professional norms. They should be able to focus on the information pertinent to a patient’s condition or concerns in a personally and culturally sensitive way. Such a patient-appropriate approach would also allow staff to devote more time to responding to patients’ questions, rather than delivering a litany of prescribed information that may not be relevant. Although counseling is labor-intensive, some patients may require counseling about a range of life issues and circumstances that impact on

PROGRAM MANAGEMENT AND ADMINISTRATION 139 their reproductive health to enable them to be more effective contraceptive users. For example, when working with teenagers, providers should assess and counsel across a range of life issues that directly affect sexual behaviors and contraceptive use. This assessment should include a careful review of the circumstances surrounding sexual behavior and choice of partners, the ability to negotiate with partners, substance use and its impact on contra- ceptive practice, and whether an abuse history or sexual assault leaves a teenager more vulnerable. Among adult women, too, many of these fac- tors, particularly abuse and intimate partner violence, require assessment and may result in the need for counseling and referral. While providers are asking for greater flexibility and individualization in their approach to patient-centered care, it is important for the Program Guidelines to ensure that patients receive appropriate services based on a proper assessment of their history and current circumstances. Serving low-income working women presents additional challenges in many localities, given that, according to testimony heard by the commit- tee, limited funding and staffing have resulted in restricted hours for some clinics. For these women, many of whom cannot take time away from their employment, the lack of evening or weekend hours creates a barrier to care. The committee notes that some clinics do use Title X funds to cover the added costs of operating outside of normal business hours. Some grantees and delegates would also like to do more, either on-site or through off-site clinics, to meet the needs of other high-risk populations, such as the homeless, substance users, those with disabilities, and those who are incarcerated. However, such expanded services would require additional resources. The program structure and funding also limit the ability of Title X clinics to provide important services relevant to healthy pregnan- cies and birth outcomes. These services include pre- and interconception care (to improve, respectively, the health of women who are considering pregnancy and attention to issues between pregnancies that may affect birth outcomes).22 conclusions and recommendations The committee drew the following conclusions about the management and administration of the Title X program: 22  hese services include prevention and management, emphasizing health issues that require T action before conception or very early in pregnancy for maximal impact, such as obesity/ weight management, adult immunizations, supplements (folic acid), mental health care, and treatment of infectious and chronic diseases (e.g., hypertension, diabetes) that could impact pregnancy and fetal health (CDC, 2006; Lu et al., 2006).

140 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM The management structure and administration of the program generally work well, but could be improved. Specific areas for improvement include overall funding levels, pharmaceutical and laboratory testing costs, birth control method availability, administrative burden, the evidence base for and flexi- bility of the Program Guidelines, transparency and communication, staffing, shortages, and informational and educational materials. The committee offers the following recommendations for achieving these improvements: Recommendation 4-1: Increase program funding so statutory responsibilities can be met. Title X should receive the funds needed to fulfill its mission of providing family planning services to all who cannot obtain them through other sources and to finance such criti- cal supplemental services as infrastructure, education, outreach, and counseling that many other financing systems do not cover. Consistent with legislative intent, financing for the program must also support research and evaluation, training, the development and maintenance of needed infrastructure, and the adoption of important new technologies. Recommendation 4-2: Examine and, if appropriate, improve m ­ ethods of allocating funds. OFP should carefully examine and, if appropriate, improve the system used to allocate funds from OFP to regions, regions to grantees, and grantees to delegates. The transparency of these funding processes should be improved so that program participants and the public are aware of the processes for making decisions about funding allocations at each level and for commenting on those decisions. Recommendation 4-3: Improve the ability to purchase drugs and diagnostics at reduced prices by consolidating purchasing sources. OFP should work with the various public and private purchasing sources for drugs and diagnostics for Title X clinics to develop a coordinated or consolidated purchasing program. Recommendation 4-4: Improve the continuity of products provided to clients of Title X clinics. The 340B drug pricing program should revise its list of available drugs less frequently and make an effort to obtain drugs with longer expiration periods. Product continu- ity would also be enhanced by the consolidation proposed under Recommendation 4-3.

PROGRAM MANAGEMENT AND ADMINISTRATION 141 Having a consolidated pharmaceutical program for Title X grantees would provide potential cost savings through bulk purchasing, as well as improved continuity of products. Having a more consistent and cost- e ­ ffective program would benefit both clinics and patients. Recommendation 4-5: Reduce the administrative burden on Title X clinics. OPA should work with other HHS agencies sup- porting family planning to coordinate patient fee schedules and record-keeping and reporting requirements. OPA should also adopt a single funding cycle, where possible, for the awarding of grants. Title X clinics bear a significant burden in budgeting for and managing their multiple sources of funding, a burden exacerbated by the multiple funding cycles for the awarding of grants. Coordination of patient fees and record-keeping and reporting requirements for the numerous federal programs involved and establishment of a single funding cycle could reduce this administrative burden, as well as associated costs. Improvement in coordination for various federal programs may require changes to legisla- tion directed at involved agencies. Recommendation 4-6: Adopt a single method for determining cri- teria for eligible services. The federal government should adopt a single method of determining criteria for eligible services (for example, which services are available at which percent of the fed- eral poverty level), what copays if any are required, and how clinics should report clients seen. The current inconsistencies create an atmosphere that discourages coordination of Health Resources and Services Administration, Centers for Disease Control and Preven- tion (CDC), and other programs with Title X. Recommendation 4-7: Review and update the Program Guidelines to ensure that they are evidence based. OFP should review the Program Guidelines annually and update them as needed to reflect new scientific evidence regarding clinical practice. In so doing, OFP should establish a mechanism for obtaining expert scientific and clinical advice in a systematic, transparent way. Expertise should be drawn from the clinical, behavioral, epidemiological, and educa- tional sciences. In addition, it is important to enhance the flexibility of Title X clinics so they can meet the needs of individual patients while adhering to evidence-based guidelines and practices. Because the required services extend beyond those included in evidence- based professional guidelines, resources are not being used most efficiently,

142 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM and the program is missing opportunities for patient-centered care. In addi- tion, outdated Program Guidelines can result in clinical practices that fail to meet current standards for medical care and for education and counseling. The latter include recommendations for screening and provision of infor- mation about disease prevention (such as those of the U.S. Preventive Ser- vices Task Force, ACOG, the American College of Physicians, the American C ­ ancer Society, and the American Academy of Pediatrics), for education (such as those of the Sexuality and Information and Education Council of the United States), and specifically for the delivery and safe use of contracep- tives (of the World Health Organization in its Medical Eligibility Criteria). OFP has issued service orders (for example, regarding cervical cytology) that direct grantees and delegates to use guidelines of professional societies. These service orders are not always disseminated promptly, however, and in any event leave delegates with conflicting requirements. Incorporating such evidence-based recommendations in a timely way and promptly communicat- ing them to grantees and delegates (through, for example, regular conference calls as well as the Internet in order to disseminate up-to-date information to all levels of program staff) could improve the effective and efficient delivery of services under Title X, as could allowing greater flexibility in service pro- vision. Finally, timely updated guidelines could be used for all federal health care programs. In this way, clinical and quality advances achieved in Title X could be used to inform other HHS family planning efforts. Recommendation 4-8: Increase transparency and improve commu- nication. OFP should increase the transparency and communication of information at all levels of the program. Such information should encompass methods for allocating program funds, the ­process for establishing annual program priorities, suggestions for program improvements, lessons learned through research supported by Title X and other programs, and how data are used. This informa- tion should be disseminated both vertically and horizontally. In light of the limited funding and opportunities for regional or national meetings, the Internet could be used to facilitate communication among grantees and RPCs across regions. Greater use of online systems could help a great deal in disseminating information, such as updates on clinical prac- tices, from the Central Office to RPCs, grantees, and delegates, as well as exchanges among grantees and from grantees to both RPCs and the Central Office. For example, this type of communication is used by the program’s national and regional training grantees, which have Internet-based service, resource, and training tools.23 A website could be developed to provide 23  ee S http://www.hhs.gov/opa/familyplanning/grantees/training/index.html.

PROGRAM MANAGEMENT AND ADMINISTRATION 143 information about policies, service requirements, changes in the Program Guidelines, and program improvements, as well as training for staff. Infor- mation useful for quality improvement could be included (see Chapter 5). Interactive components could facilitate communication at all levels. Recommendation 4-9: Assess workforce needs. With the help of an independent group, OFP and other agencies within HHS should conduct an analysis of family planning workforce projections for the United States in general and for the Title X program specifi- cally. The study should assess current and future workforce train- ing needs and the educational system capacity necessary to meet those needs. The study should also identify ways in which these needs can be met and financed. Given the current and predicted personnel needs throughout the pro- gram, national efforts to address the problem are appropriate. NFPRHA has suggested a workforce study to develop strategies for addressing recruitment and retention issues, including alternative staffing options. Outreach and collaboration with nurse practitioner training programs should be explored. As efforts are made to revise state licensure laws to require practitioners to have more advanced training (National Council of State Boards of Nursing, 2008), they must be fully evaluated for their impact on available staffing, and plans must be made to deal with shortages. To address the immediate problem, efforts should be made to ensure that current staff members receive the training needed to maintain their professional credentials under state laws and professional certification programs. The Title X training priorities have focused on program-specific issues to help grantees comply with changes in program priorities (see Chapter 3). Greater effort should be made to develop training modules that not only inform participants about program issues, but also meet continuing education requirements for nurse practitioners, certi- fied nurse midwives, and others who staff Title X clinics. This goal could be advanced through the priorities for training in the MOU between OFP and the Regional Offices. New means of providing training should also be explored. Internet-based programs could make training available to a broader audience at lower cost. Specific attention also should be given to clients’ language issues when considering workforce needs. Recommendation 4-10: Assess the local review of informational and educational materials. OFP should assess whether the benefits of local review of all educational materials outweigh the burdens, including costs. OFP should develop processes that eliminate dupli- cative reviews while also ensuring that consumers have an oppor- tunity for input at either the local or national level.

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A Review of the HHS Family Planning Program provides a broad evaluation of the Title X family planning program since its establishment in 1970. The program successfully provides family planning services to its target audience of low-income individuals, but there is room for improvement. While the program's core goals are apparent, a secondary set of changing priorities has emerged without a clear, evidence-based strategic process. Also, funding for the program has increased in actual dollars, but has not kept pace with inflation or increased costs. Several aspects of the program's structure could be improved to increase the ability of Title X to meet the needs of its target population. At the same time, the extent to which the program meets those needs cannot be assessed without a greater capacity for long-term data collection.

A Review of the HHS Family Planning Program recommends several specific steps to enhance the management and improve the quality of the program, as well as to demonstrate its direct contribution to important end results, such as reducing rates of unintended pregnancy, cervical cancer, and infertility. The book will guide the Office of Family Planning toward improving the effectiveness of the program. Other parties who will find the research and recommendations valuable include programs receiving Title X funding from the Office of Family Planning, policy makers, researchers, and professional organizations.

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