D. Rationale of HCQO Budget Request

The FY 2007 Request maintains the Research on Health Costs, Quality and Outcomes budget activity at the FY 2006 Appropriation level. The components are:

HCQO Budget Activity

Type of Grant		Request Level
I.	Research and Training Grants	-$ 11,990,000
	(Non-Competing Patient Safety Grants)	(-$ 31,428,000)
	(Non-Competing Non-Patient Safety Grants)	(-3,309,000)
	(New Patient Safety Research and Training Grants)	(+ $ 25,380,000)
	(New Non-Patient Safety Research and Training Grants)	(-2,633,000)
	(Non-Patient Safety Supplements)	(0)
II	Non-MEPS Research Contracts and IAAs	+9,525,000
	(Patient Safety Contracts and IAAs)	(+ $6,048,000)
	(Non-Patient Safety Contracts and IAAs)	(+ $3,477,000)
III	Research Management	+ $2,465,000

Mechanism Discussion at the Request

HCQO's portfolio, in terms of funding mechanisms, follows.

10 Research Portfolios System Capacity and Bioterrorism. Data Development. Care Management. Cost, Organization and Socio-Economics. Health Information Technology. Long-term Care. Pharmaceutical Outcomes. Prevention. Training. Quality/Safety of Patient Care.

Research and Training Grants

The FY 2007 Request provides $77,462,000 for research grants, a decrease of $11,990,000 from the FY 2006 Appropriation level of $89,452,000.

This budget will provide $44,941,000 in new grant funds, of which $27,814,000, or 62 percent, will be for the patient safety program.

Non-Patient Safety Research and Training Grants

The new non-patient safety grants ($17,127,000) will continue research in our three strategic plan goal areas and our 10 research portfolios of work, with an increased focus on knowledge translation. Types of grant programs that could be funded at this level include 1-year awards such as small, conference, and dissertation research grants. In addition, funds would be available for research career awards, Primary Care Practice Based Research Networks (PBRNs), and our two infrastructure training programs: BRIC and Minority Research Infrastructure Support Program (M-RISP). Within our three strategic plan goals, funds could also be directed toward our Centers for Education and CERTs program as well as research grants focused on translation of research findings into real-world settings.

Patient Safety Research and Training Grants

At the FY 2007 Request, AHRQ proposes $27,814,000 in new grants related to the Ambulatory Patient Safety program. A total of $22,000,000 in new grant funds are directed to AHRQ's continuing HIT initiative. An additional $4,814,000 in new grants are provided from general patient safety funds. The general patient safety funds will support overarching long-term goals for both the HIT and patient safety research portfolios.

Ambulatory Patient Safety Program

AHRQ proposes a $35,202,000 initiative related to Ambulatory Patient Safety, with $27,814,000 in research grants and $7,388,000 in research contracts.

Patient safety is a major concern of the general public and of policymakers at the State and Federal levels. The Institute of Medicine report To Err is Human, released in 1999, shined a spotlight on the issue of preventable medical errors and avoidable deaths and injuries. The subsequent IOM report, Crossing the Quality Chasm,released in 2001, reinforced that patient safety should be an expected system property of the U.S. health care system. Coincident with these reports, AHRQ convened a series of summits and set a comprehensive research agenda based on the expressed concerns of stakeholders and the potential impact for improvements. This agenda has served as a roadmap for AHRQ's work in patient safety and error reduction, with support for research focused on the epidemiology of errors across all settings, needed infrastructure to promote patient safety, role of HIT,adoption issues, and a special focus on transitions in care. To date, the majority of current knowledge, research, and improvement in patient safety has focused on the hospital setting. Safe high quality ambulatory care, comprising physician offices, clinics, emergency departments, and other settings, requires a capacity for complex information management and coordination. In addition, transitions between hospitals, outpatient facilities, nursing homes and home health care have been identified as high risk for avoidable errors.

Emerging information about ambulatory care suggests that the patient safety crisis in hospitals is only the "tip of the iceberg." The elderly and chronically ill Medicare population presents special challenges for care across different providers and settings. Two-thirds of Medicare beneficiaries have five or more chronic conditions, resulting in care from 14 different physicians. In a recent international survey supported by the Commonwealth Fund, 22 percent of sicker adults reported that there was an incorrect laboratory or diagnostic test or delay in receiving results; the rate was 49 percent among those sicker adults who saw four or more doctors. As a result of poor communication and information flow, 14 percent of these sicker adults reported a return visit to the emergency department or hospital readmission after discharge due to complications. Among patients who reported a medication error, 77 percent of the time they reported that it occurred outside the hospital. These safety issues result in significant morbidity and mortality, as well as significant waste due to duplicate test ordering and unnecessary visits. Many of these issues can be significantly improved with the use of HIT across all settings. The opportunity to turn the power of HIT to the ambulatory care setting, including high risk transitions, will form the cornerstone of this proposed initiative.

Over the last 5 years, the work supported by the patient safety portfolio has demonstrated the importance of understanding how errors occur across settings and the need to learn from these errors. The Patient Safety Improvement Corps (PSIC), the Patient Safety Indicators and the Culture of Safety tool have offered important resources to address safety in hospitals. In 2005, AHRQ's statute was amended by Public Law 109-41 to provide for the establishment of patient safety organizations (PSOs) nationwide that will collect information from providers about adverse events affecting patient safety. These PSOs will be working with providers across diverse health care settings, including ambulatory care settings, to collect information on patient safety events and to assist these providers in analyzing causes of such events and developing solutions to decrease their incidence. This work will build on current and prior investments (e.g., reporting demonstrations on medication errors in ambulatory care; current work with CMS on e-prescribing; evaluating physician readiness for e-Rx) and form the bedrock of our future investments in patient safety and HIT in the ambulatory care setting.

AHRQ is committed to a major program to both understand and improve the quality and safety of care in ambulatory settings in FY 2007. There is a desperate need for better information sharing and availability at the point-of-care. AHRQ's significant investment in hospital safety has demonstrated the importance of patient safety reporting systems, computerized provider order entry, and decision support systems to key stakeholders and policymakers. While the use of hospital-based IT for patient safety has been rising, an adoption gap exists in ambulatory care, especially in smaller practices where 60 percent of physicians continue to practice with five or fewer doctors. Major obstacles to achieving safe, patient-centered healthcare across settings are fragmentation of the delivery system and differing levels of investment in information systems that can support safety monitoring and quality improvement. AHRQ's initiative will assure that recommendations of the American Health Information Community and recent and near-future policy decisions to promote interoperability will result in tangible improvements in safety and quality.

Program Goal and Objectives

The Ambulatory Patient Safety Program has a 5-year goal of measurably improving the safety and quality of care for patients in ambulatory environments. AHRQ will examine the best ways to develop, deploy, and evaluate the use of electronic health information systems—both the technology and the processes around it—by addressing systemic barriers to adoption and creating the evidence base for best practices. Moreover, AHRQ will take advantage of its prior investments in research networks, assuring rapid uptake of research results. These networks include a research network with integrated delivery systems, a national practice network of primary care practices, and a network of centers providing care to patients with HIV that provides near real-time information on utilization and quality of care. In this way, the Agency can first demonstrate the relationship between HIT, safety, and quality, and rapidly establish how to get the greatest benefit (clinical and financial) from investments in HIT.

This 5-year program will develop and integrate similar improvements in ambulatory environments, preparing the way for fully integrated systems of care. The program will include special attention to the delivery of high quality care from providers in rural, small community, safety net, and community health center environments.

The program will focus on four cross-cutting care domains to achieve goal—improvements in medication safety, patient-centered care, medication management, and integration of decision support tools. Improvements in these specific areas—all dependent on HIT integration—have been shown to affect the overall quality of care.

Ambulatory Patient Safety Program Program Objectives—FY 2007 Improve the safety and quality of prescription drug management via the integration and utilization of medication management systems and technologies. Improve the delivery and utilization of evidence-based care in ambulatory settings. Specific attention will be given to clinician workflow, health information exchange with and emphasis on chronic disease. Improve the delivery of patient-centered care in ambulatory care settings, including specific focus on transitions of care, personal health records, and improved patient-provider communication and decisionmaking. Foster the development, deployment, and reporting of measures of safety and quality in ambulatory care settings and across high risk transitions in care.

Description of Specific FY 2007 Programs

The projects, research grants, pilot programs, expert analysis, and demonstrations are designed to work synergistically with efforts already underway at AHRQ, HRSA, CMS, ONC, and other public and private stakeholders. Furthermore, the efforts will endeavor to engage partnerships (community, regional, and State), rural, and other health care safety net providers. The two large programs will focus on medication management and the need for improved decisionmaking in ambulatory care.

1. Improving Medication Safety and Management in Ambulatory Care Settings

Investments: $14,000,000
Grants: $11,000,000 ($9,000,000 HIT and $2,000,000 general patient safety)
Contracts: $3,000,000 (HIT funds)

Medications for individual patients are prescribed across a wide variety of settings for a wide variety of conditions. Major obstacles to achieving safe, patient-centered health care for Americans are fragmentation of the delivery system and differing levels of investment in information systems. For example, medications prescribed for chronic illnesses in the ambulatory setting are often lost during transition to hospital and home health care. This is especially important because adverse drug interactions are a primary area of concern for patient safety, and one which can be easily addressed through better information. In many cases, the needed technology capabilities already exist. This program will build on AHRQ's substantial experience with the exchange of medication information from State and regional demonstrations and research networks.

AHRQ will award grants and contracts to individual researchers and partnerships to develop, demonstrate, and implement evidence on:

• Barriers and opportunities to the utilization of HIT-based medication management systems.
• Management of prescription drugs across care settings.
• Improved tools for providers, care givers, and patients, including tools to enhance coordination of care among multiple providers.
• Integration with decision support and other HIT tools.
• Utilization of health information exchange of medication information.

These grants and contracts require the strong partnership of organizations that see patients in different ambulatory settings, including the pharmacy and long-term care settings. The initiative will focus on the ability of the patient and provider to have a cohesive picture of all of the medications that the patient is currently prescribed, management of the transition across care settings, health information exchange, and mechanisms for effective followup.

The technologies that may enable such medication management include but are not limited to: electronic prescribing, point-of-care decision support, portable health records, and health information exchange. The projects can explore best practices across care settings, standardization, barriers to health information exchange, and emergency/disaster preparedness. The entities involved must include some ambulatory settings, and a portion of the funds will be set aside for partnerships that include a member from a rural area, a safety net organization, or a community health clinic. Specific involvement of patients and access to these data for patients to use across settings will be emphasized. Each proposal should address how the project will further regional or State patient safety or quality improvement efforts. The outcome of the projects will inform the HIT community by identifying barriers to adoption and examples of best practice solutions.

AHRQ's research networks, including the PBRNs, ACTION networks, and the HIV Research Networks will be utilized to better understand how HIT can result in safer medication use in ambulatory care and across transitions in care.

2. Safer Decisionmaking in Ambulatory Care for Patients and Providers

Investment: $21,202,000
Grants: $16,814,000 ($13,000,000 HIT and $3,814,000 general patient safety)
Contracts: $4,388,000 (HIT)

AHRQ will engage in work to improve decisionmaking as a method for improving ambulatory safety. Health IT can improve healthcare in many ways, but one of the most significant potentials is bringing best safety and quality practices to the point of care by guiding the decisions of patients and providers. AHRQ will engage in work to improve decision support, improving ambulatory safety and safety. This improved decisionmaking capacity will specifically incorporate personal health technologies, including personal health records and other HIT tools to better allow patients and providers to determine the best course of care. This initiative will also focus on the need for incorporation of system redesign in ambulatory settings with implementation of HIT. There is also a need to develop better measurement tools that will allow us to gauge the effect of greater investment in ambulatory care and patient-centered systems to improve patient safety.

The Agency will utilize a host of internal and external research networks to best evaluate and demonstrate better care through improved decisionmaking in the ambulatory environment. Research networks will include the PBRNs, ACTION networks, and the HIV Research Networks.

AHRQ will award grants and contracts to individual researchers and partnerships to develop and demonstrate how to:

• Overcome barriers to effective use of decision support in ambulatory care settings.
• Improve safety and quality from electronic decision support.
• Develop actionable, evidence-based decision support tools for clinicians and patients.
• Develop standardized research output directed at improving safety and quality.
• Integrate current evidence into HIT (such as personal health records (PHRs), electronic health records (EHRs), and higher level architectures) at the National level.
• Advance the capability of HIT to incorporate current evidence into decision support systems.
• Support the alignment of care redesign with implementation of HIT in ambulatory settings.

To advance knowledge in the field and to support AHRQ's responsibilities for implementing the Patient Safety legislation across settings, this initiative will also support greater emphasis on safety and quality measurement and reporting. Emerging patient safety organizations will be encouraged to apply. Specific measurement initiatives will include:

• Determining measures of importance in ambulatory care settings (assessing priorities, specifying events in measurable terms, estimating cost of extraction).
• Improving methods of detection of errors in ambulatory care.
• Establishing a culture of safety in ambulatory care (including development and use of a culture survey in ambulatory settings).
• Developing new ambulatory safety and quality measures through the HCUP Quality Indicators initiative, including measures of coordination, efficiency, safety metrics for transition points (e.g., emergency departments), and priority conditions (e.g., HIV, asthma).

Non-MEPS Research Contracts and Inter-Agency Agreements (IAAs)

The FY 2007 Request provides an increase of $9,525,000 for non-MEPS research contracts and IAAs from the FY 2006

Appropriation of $115,733,000. The support for non-patient safety research contracts and IAAs increases by $3,477,000. The bulk of the non-patient safety increase, $1,940,000, is directed to a one-time only expenditure for the MEPS program. Patient safety research contracts and IAAs receive an increase of $6,048,000.

Non-Patient Safety Research Contracts and IAAs

Support for non-patient safety contracts and IAAs increases by $3,477,000 at the FY 2007 Request. Of this increase, $1,940,000 will be directed to two technical changes to the MEPS contract. A total of $1,100,000 will support a portion of the funding needed to operationalize the transition in MEPS to a Windows®-based CAPI system. A total of $840,000 will facilitate linkages between the MEPS Insurance Component and the MEPS Household Component, allowing for enhanced analytical capacity.

In addition, AHRQ will provide new non-patient safety contract and IAA funds that will focus on knowledge translation within our three strategic plan goal areas and our 10 research portfolios of work.

Patient Safety Research Contracts and IAAs

In terms of patient safety, research contracts and IAAs total $45,709,000 at the FY 2007 Request, an increase of $6,048,000. An increase of $7,388,000 for the new FY 2007 Ambulatory Patient Safety Program is offset by a reduction in ongoing research contracts and IAAs of $1,340,000.

Ambulatory Patient Safety Program

The research contract and IAA component of AHRQ's $35,202,000 Ambulatory Patient Safety Program is funded at $7,388,000. Select for a discussion of the overall objectives of the Ambulatory Patient Safety program. Research contracts and IAAs will support all program objectives. In addition, contracts are proposed to provide program and technical assistance to patient safety organizations, development of common definitions for reporting of errors and near misses in ambulatory care, and implementation efforts. AHRQ notes the need for assistance in the evaluation, technical, expert, coordination, and knowledge management aspects of patient safety and HIT projects. Noting the need to measure changes in the quality of care, integrate technology into already complex systems and integrate best-practices, the Agency will continue current efforts led by the AHRQ's National Resource Center for HIT, the Patient Safety Improvement Corps, and Patient Safety Net. Future iterations will focus on innovative methods to deliver assistance, e.g., peer-to-peer networks and medical professional organizations.

Patient Safety and Quality Improvement Act of 2005

In addition, beginning in FY 2006 and continuing into FY 2007, AHRQ has provided $3,000,000 in contract funds within the patient safety budget PL 109-41, the Patient Safety and Quality Improvement Act of 2005 (Public Law No. 109-41). The Patient Safety Act is intended to help health care providers study and improve patient safety and the quality of health care delivery by encouraging the voluntary creation of confidential patient safety evaluation systems.

The Patient Safety Act requires the Secretary to establish a process for certification, periodic recertification, and revocation (for cause) of Patient Safety Organizations (PSOs). The legislation envisions that PSOs will enter into contracts with providers to assist providers with the identification, analysis, and correction of threats to patient safety. The Act provides Federal privilege and confidentiality protections against disclosure of information that is assembled or developed and reported to a PSO or developed by a PSO for the conduct of required patient safety activities. Within this protected framework, the Act encourages health care providers (the term includes health care practitioners and health care institutions) to contract with one or more PSOs:

• To collect and analyze data on patient safety events (a term that encompasses "near misses," "close calls," and "no-harm" events, and all types of medical and other health care adverse events).
• To develop and disseminate information to improve patient safety and to provide feedback and assistance to effectively minimize patient risk.

The Act also requires that the Secretary facilitate the creation of, and maintain, a network of patient safety databases that provides an interactive evidence-based management resource for providers, patient safety organizations, and other entities. The Act further states that the network of databases shall have the capacity to accept, aggregate across the network, and analyze non-identifiable patient safety work product voluntarily reported by patient safety organizations, providers, or other entities. In addition, the Act provides that information reported to and among the network of patient safety databases shall be used to analyze national and regional statistics, including trends and patterns of health care errors. Information from these analyses of statistics and trends is to be made publicly available and included in annual reports by the Secretary to Congress on the quality of American health care. AHRQ is committed to continue funding these activities in FY 2007.

Research Management

The FY 2007 Request provides an increase of $2,465,000 for research management costs. These funds will provide for mandatory increases, an additional four FTEs, and funds for the Unified Financial Management System.

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