Combating Autism Act: HHS Agencies Responded with New and Continuing Activities, Including Oversight
Released: 2013-02-27T00:00:00

Letter

Background

Autism—a complex and pervasive developmental disability—usually becomes evident in early childhood, although signs and symptoms vary.According to CDC, autism begins before age 3 and lasts throughout a person’s life. Some children show signs of autism within the first few months of life. In others, symptoms might not appear until 24 months or later. Still other children with autism seem to develop typically until 18 to 24 months of age and then stop gaining new skills or lose the skills they once had. Signs and symptoms of autism include a child not responding to his or her name by 12 months; not pointing at objects to show interest by 14 months; avoiding eye contact and wanting to be alone; repeating words or phrases over and over; and flapping hands, rocking, or spinning in circles. Individuals with autism might have challenges with showing or talking about their feelings and might also have trouble understanding the feelings of others.

Diagnosing autism can be difficult; however, early intervention services can greatly improve a child’s development. There is no medical diagnostic test available for autism. As a result, doctors consider a child’s behavior and development to make a clinical diagnosis. By age 2, a diagnosis by an experienced professional can be considered very reliable. However, according to CDC most children do not receive a diagnosis until after age 4. There is no single cause of autism, but a variety of factors are suspected of causing or contributing to autism, including environmental, biological, and genetic sources. While there is no known cure, research shows that early intervention services can greatly improve a child’s development. Because of the complexity of this disorder, individuals with autism have diverse needs for medical and mental health care as well as an array of educational and social services.

The CAA authorizes and directs HHS to conduct specific autism-related activities, which may include funding external organizations to conduct these activities through grants, contracts, and cooperative agreements. The CAA amended sections of the Children’s Health Act of 2000—which required HHS to conduct activities related to autism research, surveillance, and coordination—by revising some sections and repealing other sections of that law as well as establishing new requirements.CAA authorized, but did not appropriate, federal funding to carry out these activities in fiscal year 2007 through fiscal year 2011.

HHS Agencies Responded to the CAA by Establishing New Autism Activities and Continuing Others

HHS agencies responded to the CAA with new or continuing autism activities. In fiscal year 2008, HRSA created the Combating Autism Act Initiative in response to specific directives included in the CAA. Through this initiative, HRSA expanded its existing training programs to include an autism-specific component and established new autism research and state grants. HRSA conducts all of its Combating Autism Act Initiative programs under the authority of the CAA. HRSA staff told us that they have not analyzed whether the agency’s new programs could be conducted under other HRSA authority.

HRSA expanded two of its preexisting training programs—the Leadership Education in Neurodevelopmental and Other Related Disabilities (LEND) and the Developmental-Behavioral Pediatrics (DBP) training programs— through supplemental funding to existing grantees and awards to new grantees. These two training programs account for the majority of HRSA spending under its Combating Autism Act Initiative; however, HRSA was funding these programs prior to enactment of the CAA.Combating Autism Act Initiative, LEND and DBP grantees are required to include an autism component in their training. Among other things, the programs train health care professionals, such as pediatric practitioners, residents, and graduate students, to provide evidence-based services to children with autism and other developmental disabilities and their families; and train specialists to provide comprehensive diagnostic evaluations to address the shortage of professionals who can confirm or Under the rule out an autism diagnosis. According to HRSA, as a result of these training programs, the number of health professionals enrolled in autism courses increased from 1,887 in academic year 2008-2009 to 4,256 in academic year 2010-2011 and the number of diagnostic evaluations increased from 12,390 in academic year 2008-2009 to 44,102 in academic year 2010-2011.

Additionally, HRSA created new autism research programs to fund studies that are intended to advance the current autism knowledge base and lead to improvements in interventions that address the health and well-being of children and adolescents with autism and other developmental disabilities. HRSA also provided grants to establish two research networks that focus on the physical and behavioral health needs of children and adolescents with autism. These networks conduct research on evidence-based practices for interventions, promote the development of evidence-based guidelines for intervention, validate tools for autism intervention, and disseminate information to health professionals and the public, especially families affected by autism.

HRSA also funded new state implementation and planning grants to implement plans to improve access to comprehensive, coordinated health care and related services for children and youth with autism and other developmental disabilities. Twenty-two states received grants from fiscal years 2008 to 2011 to implement their autism plans. These plans vary by state, but common elements include a focus on partnerships between professionals and families of children and youth with autism, access to a culturally competent family-centered medical home, access to adequate health insurance and financing of services, early and continuous screening for autism and other developmental disabilities, community services organized for easy use by families, and transition services for youth entering adult health care. Table 1 provides information on the specific autism-related programs HRSA initiated or expanded—by increasing funding and the number of grantees—as a result of the CAA.

NIH and CDC continued the autism activities each implemented prior to the enactment of the CAA, but did not create new programs as a direct result of the CAA. Some of these activities had been undertaken in response to the Children’s Health Act of 2000, which, like the CAA, charges NIH with expanding, intensifying, and coordinating research on autism. In addition, under both laws, CDC is required to conduct activities related to establishing regional centers of excellence to collect and analyze certain information on autism. Since the enactment of the CAA, NIH continued to fund, expand, and coordinate autism research through its Autism Centers of Excellence and autism-specific grants and contracts. According to agency officials, NIH awards these grants and contracts under its general Public Health Service Act authorities and not under the specific authorities provided in the CAA.fund its regional centers of excellence for autism epidemiology and other activities, such as an awareness campaign on autism and other developmental disabilities. While enactment of the CAA did not result in any change to CDC’s autism activities, CDC officials stated that the CAA provided additional focus on these efforts. According to CDC officials, the CAA’s enactment also strengthened the agency’s Learn the Signs. Act Early. awareness campaign by elevating the importance of increasing awareness of developmental milestones to national visibility. See appendix I for a list of NIH’s and CDC’s autism efforts.

As required by the CAA, the Interagency Autism Coordinating Committee (IACC)—initially established under the Children’s Health Act— restructured its membership and assumed additional responsibilities to coordinate autism efforts within HHS. The CAA reauthorized the IACC and specified that the IACC include both federal and nonfederal members. IACC membership expanded to include 11 nonfederal members that represented individuals with autism and parents of children with autism. In addition, it included members of the autism advocacy, research, and service-provider communities in accordance with the CAA’s membership requirements. The CAA also directed the IACC to develop and annually update a strategic plan and summary of advances in autism research, and monitor federal autism activities. Since fiscal year 2007, the IACC issued several reports as a means to coordinate HHS autism efforts and monitor federal autism activities, some of which were specifically required by the CAA, such as the development of an autism strategic plan and a summary of advances in autism research.appendix II for a description of the documents produced by the IACC.

In addition to the changes to the IACC, in 2008, NIH created the Office of Autism Research Coordination (OARC) within the National Institute of Mental Health (NIMH) to coordinate and manage the IACC and related cross-agency activities, programs, and policies. OARC assists the IACC by conducting analyses and preparing reports for the IACC, assisting with the IACC’s strategic planning and autism research monitoring, and providing logistical support for IACC meetings. It also supports communications through the IACC website and press releases, and responds to inquiries from the public and other government agencies.OARC officials told us that although HHS could establish an advisory committee similar to the IACC under other authority, the CAA has provided the IACC with greater visibility and increased involvement of the public and federal agencies, through, for example, the annual update of the IACC’s autism strategic plan.

While the CAA authorized appropriations for HRSA, NIH, and CDC autism activities, the CAA did not appropriate funds for this purpose. Instead, to fund these activities, HRSA, NIH, and CDC used funds appropriated to the agencies annually through the budget and appropriations process for the purpose of carrying out a variety of programs.

Reinvestment Act of 2009. And, according to CDC officials, the agency redirected a portion of its funding for infant health activities to support pilot projects implementing the agency’s awareness campaign on autism and other developmental disabilities. The IACC’s funding increased significantly from fiscal year 2006 to 2011. From fiscal year 2008 through fiscal year 2011, as directed by Congress in the annual HHS appropriations act, the Secretary of Health and Human Services transferred funds to NIMH for the IACC. From fiscal year 2006 through fiscal year 2011, the IACC also received funds from the annual NIH appropriation. See appendix III for information on the funding for these agencies’ and the IACC’s autism-related activities.

HRSA Routinely Collects and Reviews Information to Oversee CAA Grantees

HRSA, the only HHS agency that awarded grants specifically as a result of the CAA, regularly collects and reviews information from grantees to oversee individual CAA grantees as well as to provide oversight to its CAA programs. HRSA awarded approximately $164 million in grants to 110 CAA grantees from fiscal years 2008 to 2011. The majority of funding—about $107 million—was awarded to 47 grantees within HRSA’s LEND training program, some of which were already receiving funds prior to the CAA. In addition, nearly $24 million was awarded to two grantees to support HRSA’s two autism intervention research networks. For all grantees, the amount of the grant award per year ranged widely from about $36,000 to $4 million depending on the CAA program, as shown in appendix IV.

As part of the agency’s oversight of its CAA grantees, HRSA requires periodic reports from these grantees, which are reviewed by HRSA staff. HRSA project officers within the Maternal and Child Health Bureau—the bureau that administers the CAA programs—are responsible for working with CAA grantees in overseeing the programmatic and technical aspects of the grant. HRSA grants management specialists and their supervisors—grants management officers—oversee compliance with financial reporting requirements and agency grant policies and regulations. The required reports that are reviewed by HRSA staff include the following:

Annual federal financial report. The annual federal financial report is an accounting of expenditures under the project in the budget period—the period for which HRSA has awarded funds to the grantee—and cumulatively for the project period.after the end of the budget year.

Annual progress reports. The annual progress report is part of a grantee’s noncompeting continuing application and describes grantees’ progress on their grant objectives. Progress reports are due before the end of the budget period because HRSA staff use these reports to assess progress and, except for final progress reports, to determine whether to provide funding for the budget period subsequent to that covered by the report.

Mid-project progress reports. Mid-project progress reports provide information on grantees’ progress on research objectives. These reports are required of certain research grantees and are due midway through the project period.

Semiannual progress reports. Semiannual progress reports include information on the grantees’ most significant achievements and problems encountered during the reporting period as well as the grantees’ progress on established objectives. These reports are required of research network grantees and are due midway through each budget period.

In addition to reports, HRSA also requires grantees to submit written requests before making certain changes to the grant project, known as prior-approval requests. For example, a change in the director of the grant project requires prior approval, as does a request to carry over unobligated funds to the next budget period or a request for a no-cost extension—an extension for a limited period beyond the end of the project period so that the grantee can complete project activities.

When reviewing these reports and grantee prior-approval requests, HRSA staff are required to fill out checklists in the EHB in which they indicate their review and approval of the report or request. The content of the review checklists varies by the type of report or request being reviewed. For example, among other questions, a progress report checklist asks if the report reflects the program’s goals. The federal financial report checklist asks HRSA staff to compare the report with data in HRSA’s payment management system. All review checklists include a question where HRSA staff can indicate if they have identified any issues or concerns with the report or request. In addition, when reviewing grantee information, HRSA staff may request that a report be revised with additional or corrected information.

Our review found that HRSA routinely collects and reviews information submitted by CAA grantees. Generally, grantees submitted required reports and HRSA staff documented their review of these reports. Specifically, the 22 grantees in our unbiased random sample submitted all of the 106 reports they were required to submit and most of these reports were submitted on time. We found that HRSA staff filled out checklists approving all of the reports submitted or required report revisions. In many cases, HRSA staff filled out a checkbox indicating a “yes,” “no,” or “n/a” response to the questions. However, we noted that there were some cases where staff provided a narrative description to support their response to the question, such as a description of how the grantee is meeting the program’s goals—a question in the progress report checklist. HRSA officials stated that staff are required to answer the questions in the checklist, but they are not required to provide a narrative supporting their answers.

We observed that there were few instances of HRSA staff either documenting a concern or asking for a report revision before approving the report. We encountered seven instances where a project officer approved a report, but documented a concern in a checklist. In all these instances, the project officer provided narrative describing the concern. For example, in one instance, the project officer wrote that the grantee’s recruitment of study subjects—parents of children with autism or other developmental disabilities—was slow. However, the project officer also stated that the grantee modified its enrollment process, which seemed to be having some positive effect and that the project officer and grantee were working together to monitor enrollment. We also identified another seven instances where HRSA staff asked for a report to be revised either with additional or corrected information. In almost all instances, the grantees submitted a revised report and HRSA staff completed a checklist indicating approval of the revised report.

The question in the checklist is: “Are there any areas of concern: programmatic, budgetary, or other?” the next budget period. For example, 13 of the 22 grantees in our review requested to carry over unobligated balances at least once during the period of our review, and many of them requested it for multiple years— equaling 32 separate requests. The amount of unobligated balances that grantees requested to carry over in a given year ranged from $1,518 to $172,514. In all instances, HRSA approved these requests as indicated by the issuance of a revised notice of award. Almost all requests related to awards in fiscal year 2010 and later contained an associated checklist in the EHB filled out by HRSA staff approving the request to carry over unobligated balances.

In addition to reviewing information submitted by grantees, HRSA provides additional oversight to grantees. First, it conducts site visits in person or by means of the web. During a site visit, HRSA staff may collect information on preliminary research findings, data and analysis, and any challenges the grantee is facing. Site visits are only required of certain research grantees, although HRSA may conduct site visits with other grantees, depending on available resources. HRSA officials target site visits for CAA grantees on the basis of six criteria: (1) the grantee is new, (2) there has been a change in the grantee’s project director, (3) there has been a change in the grantee’s scope of work, (4) there are budgetary issues or the grantee has not made adequate progress on the project goals, (5) the grantee has requested technical assistance, or (6) there has been a change in the project officer overseeing the grantee. HRSA uses a site-visit report to document the visit and has guidance on what should be included in the report. For example, for training grants, the report should include a narrative summary of the visit including highlights, performance measure progress, strengths and challenges, and any technical assistance needed by the grantee. Second, HRSA officials stated that HRSA project officers provide routine technical assistance to certain grantees and others on an as-needed basis. For example, all research grantees have either a monthly, biweekly, or mid-project telephone call with HRSA project officers.

Our review confirmed that HRSA has conducted a number of site visits to monitor CAA grantees. For example, nine of the grantees in our review had documentation indicating that a site visit had been conducted, with only two of these being required site visits. While none of the site-visit reports identified major issues that required corrective action, some did record challenges the grantees were facing or made suggestions. For example, one report stated that the grantee may encounter challenges in the recruitment of trainees. We identified documentation related to technical assistance that HRSA staff provided to some grantees but not all. For example, we did not always see documentation of routine telephone calls with research grantees that HRSA officials say occur on a regular basis. In response, HRSA officials stated that not all technical assistance is recorded in the EHB; only when a significant issue arises is the telephone call, e-mail, or other assistance recorded.

Besides overseeing specific grantees, HRSA monitors its CAA activities at the program level by regularly collecting performance reports from grantees. The 22 CAA grantees in our sample submitted all the required performance reports. According to HRSA officials, the primary purpose of performance reports is to gauge program performance. For example, data in performance reports is currently being used by a HRSA contractor to prepare a report on the progress of the CAA programs for Congress. In addition, according to HRSA officials, performance data can be used to modify program performance measures over time. While performance reports are used to monitor CAA programs—as opposed to grantees— HRSA officials stated that some performance information is also included in annual progress reports, which are used to oversee specific grantees. For example, progress reports require grantees to include information on whether they are having problems meeting their performance measures. Finally, to further help oversee CAA programs and consolidate information on its monitoring approach for these programs, in December 2012 HRSA released a grant-management operations manual to outline its overall approach for monitoring these programs. According to HRSA officials, this manual will be included in the program folder of the EHB for each of its CAA programs and will be reviewed annually, consistent with HHS guidance.

Agency Comments

We provided a draft of this report to HHS for comment. HHS provided technical comments that we incorporated, as appropriate.

We are sending a copy of this report to the Secretary of Health and Human Services. In addition, the report is available at no charge on the GAO website at http://www.gao.gov.

If you or your staff have any questions about this report, please contact me at (202) 512-7114 or crossem@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix V.

Appendix I: National Institutes of Health’s (NIH) and Centers for Disease Control and Prevention’s (CDC) Autism Activities

During fiscal year 2006 through fiscal year 2011, NIH and CDC funded a number of autism activities. Table 2 lists the activities these agencies funded, including the type and purpose of each activity.

Appendix II: List of Interagency Autism Coordinating Committee (IACC) Reports

Appendix II: List of Interagency Autism Coordinating Committee (IACC) Reports Description According to the IACC, the Strategic Plan provides a blueprint for autism research that is advisory to the Department of Health and Human Services and serves as a basis for partnerships with other agencies and private organizations involved in autism research and services. The 2011 Strategic Plan is organized around seven questions asked by individuals with autism and their families (such as “When should I be concerned?”). Each of the seven sections includes a description of what is generally known from autism research for that particular question and what gaps remain, followed by what was learned during the previous year. The report also sets up short- and long-term research objectives based on autism research opportunities. The Combating Autism Act of 2006 (CAA) requires that the Strategic Plan be updated on an annual basis.

The Portfolio Analysis features autism project and funding information for certain federal agencies and private organizations. According to officials within the National Institutes of Health Office of Autism Research Coordination (OARC), the agencies and organizations in these reports have been identified by the IACC and OARC as being involved in autism research and have agreed to participate. According to the IACC, the intent of these analysis reports is to better inform the IACC and interested stakeholders about the funding landscape for a particular year. Additionally, the analysis examines the extent to which a particular year’s funding and research topics align with the IACC’s most recent Strategic Plan. The IACC reports that the Portfolio Analysis may also be used by federal agencies and private research organizations to help guide future funding priorities by outlining current gaps and opportunities in autism research, as well as serving to highlight current activities and research progress. OARC officials told us that they plan to issue the 2011 report in 2013.

Summary of Advances in Autism Spectrum Disorder Research (2007, 2008, 2009, 2010, 2011)

Each year the IACC releases its list of scientific advances in autism research. As reported by the IACC, the report highlights studies on autism published in the previous year in peer-reviewed journals and selected by members of the IACC. The number of studies featured over the years ranges from 20 to 54. The CAA requires that the IACC produce the Summary of Advances annually.

As reported by the IACC, this report describes several key aspects of worldwide autism research publications, which may be used to inform planning and strategic funding decisions for future autism research. Autism-related research articles published between 1980 and 2010 were analyzed to identify historical trends and publication outputs across the seven questions and research areas of the 2011 IACC Strategic Plan. Information found in research publications was also used to assess the institutions conducting autism research, funding organizations supporting the research publications, and the extent of collaboration between authors from different countries and research institutions. Additionally, measures, such as citation counts, were used as an assessment of the impact of the published research. OARC officials told us that there are no plans to update this report annually.

In 2008 and 2010, OARC, National Institute of Mental Health, prepared this report on behalf of the IACC. In 2009, OARC, National Institute of Mental Health, and Acclaro Research Solutions, Inc., prepared this report on behalf of the IACC.

Appendix III: Department of Health and Human Services (HHS) Funding for Autism Activities for Fiscal Years 2006 through 2011

HHS component Health Resources and Services Administration (HRSA)

Centers for Disease Control and Prevention (CDC)

HRSA’s totals include autism grant awards, as well as, for example, funding used for HRSA’s personnel expenses, travel, supplies, and overhead related to reviewing these grants. NIH’s totals include funding for research that is conducted outside of NIH’s autism-specific grant announcements. According to NIH officials, much of the autism research funded by NIH is done under general grant announcements soliciting biomedical research. IACC’s totals for fiscal years 2008 through 2011 include funding for the Office of Autism Research Coordination within NIMH.

In fiscal year 2008, certain agencies, including HHS agencies, were subject to an across-the-board rescission. All nondefense discretionary programs were subject to an across-the-board rescission in fiscal year 2011. According to HRSA officials, HRSA spent less on its autism activities in these years as a result of the rescissions. NIH officials told us that the agency reduced funding for research grants as a result of the rescissions, but could not measure the precise effect on autism-related grants. According to CDC officials, CDC spent less on its autism activities in fiscal year 2011 as a result of the rescission in that year. In addition, the IACC received less funding in fiscal years 2008 and 2011 as a result of the rescissions.

HRSA’s fiscal year 2006 and 2007 funding represents total funding for its Leadership Education in Neurodevelopmental and Other Related Disabilities and Developmental-Behavioral Pediatrics training programs, through which the agency awarded grants that could have had an autism-specific component; however, an autism-specific component was not a requirement of the grants. Beginning in fiscal year 2008, these training programs were required to have an autism-specific component.

Appendix IV: Combating Autism Act Grantees from Fiscal Years 2008 through 2011 by Program

In fiscal year 2008, in response to the Combating Autism Act, the Health Resources and Services Administration (HRSA) created the Combating Autism Act Initiative. Under this initiative, HRSA has a number of programs that fund grants specific to autism. This appendix includes a description of the purpose of each program. Tables 3 through 11 list the grants that have been awarded under each program for fiscal years 2008 through 2011.

Program: Leadership Education in Neurodevelopmental and Other Related Disabilities (LEND) Training Program. The purpose of this program is to improve the health of children who have, or are at risk for developing, neurodevelopmental and other related disabilities by training professionals to assume leadership roles, and to ensure high levels of interdisciplinary clinical competence in an effort to increase diagnosis of or rule out individuals’ developmental disabilities, including autism.

Program: Developmental-Behavioral Pediatrics (DBP) Training Program. The purpose of this program is to train the next generation of leaders in developmental-behavioral pediatrics; and provide pediatric practitioners, residents, and medical students with essential biopsychosocial knowledge and clinical expertise. This program is focused on developmental disabilities, including autism.

Program: National Combating Autism Interdisciplinary Training Resource Center. The purpose of this program is to improve the health of children who have, or are at risk for developing, autism and other developmental disabilities by providing technical assistance to LEND and DBP programs to better train professionals to utilize valid and reliable screening tools for diagnosing or ruling out autism, and provide evidence- based interventions for children.

Program: Autism Intervention Research Program and Autism Intervention Secondary Data Analysis Studies Program. The purpose of this program is to support research on evidence-based practices for interventions to improve the health and well-being of children and adolescents with autism and other developmental disabilities. The Autism Intervention Secondary Data Analysis Studies Program utilizes the analysis of existing secondary data.

Program: Autism Intervention Research Network on Physical Health. The purpose of this program is to establish and maintain a network infrastructure designed to be the platform from which to conduct research on evidence-based practices for interventions to improve the physical health and well-being of individuals with autism and other developmental disabilities; develop evidence-based guidelines and validate tools for interventions; and disseminate critical information on its research findings, guidelines, and tools.

Program: Autism Intervention Research Network on Behavioral Health. The purpose of this program is to establish and maintain a network infrastructure designed to be the platform from which to conduct research on evidence-based interventions to improve the behavioral, mental, social, or cognitive health, or a mix of those, and well-being of children and adolescents with autism and other developmental disabilities; develop evidence-based guidelines and validate tools for interventions; and disseminate critical information on its research findings, guidelines, and tools.

Program: Developmental-Behavioral Pediatrics Research Network. The purpose of this program is to establish a multicenter scientific and clinical research network that will promote coordinated research activities and address health issues. The program is intended to build a developmental behavioral pediatric research infrastructure that supports multidisciplinary research, focuses on the translation of research to practice, and provides the environment in which to train a new generation of developmental behavioral pediatric researchers.

Program: State Implementation and Planning Grants. The purpose of this program is to improve access to comprehensive, coordinated health care and related services by implementing state plans to improve the system of services.

Program: State Public Health Coordinating Center. The program purpose is to improve the health of children who have, or are at risk for developing, autism and other developmental disabilities by coordinating with the state demonstration grantees; and by developing a strategy for defining, supporting, and monitoring the role of state public health agencies in assuring early and timely identification, diagnosis, and intervention.

Appendix V: GAO Contact and Staff Acknowledgments

GAO Contact

Staff Acknowledgments

In addition to the contact named above, Geri Redican-Bigott, Assistant Director; Katherine L. Amoroso; George Bogart; Deirdre Brown; Sandra George; Cathleen Hamann; Kristin Helfer Koester; Drew Long; and Sarah Resavy made key contributions to this report.