Research on Health Costs, Quality and Outcomes (HCQO)

Funding		FY 2007 Enacted	FY 2008 Enacted	FY 2009 Estimate	FY 2009 Request +/- FY 2008
Total	Budget Authority	0	0	0	0
	Public Health Service (PHS) Evaluation Funds	$260,986,000	$276,564,000	$267,664,000	($8,900,000)
Full Time Equivalents (FTEs)		271	277	278	1

FY 2009 Authorization: Title III and IX and Section 937(c) of the Public Health Service Act and Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003.

Allocation Method: Competitive Grant/co-operative agreement, Contracts, and Other.

5-Year Table Reflecting Dollars and FTEs

Funding for the HCQO program during the last 5 years has been as follows:

Year	Dollars	FTEs
2004	$245,695,000	268
2005	$260,695,000	264
2006	$260,695,000	270
2007	$260,986,000	273
2008	$276,564,000	277

Research Priorities

Comparative Effectiveness

Program		FY 2007 Enacted	FY 2008 Enacted	FY 2009 Estimate	FY 2009 Request +/- FY 2008
Comparative Effectiveness	Personalized Health Care	$0	$0	$0	$0
	Effective Health Care	$15,000,000	$30,000,0000	$30,000,0000	$0
Total		$15,000,000	$30,000,000	$30,000,000	$0

FY 2009 Authorization: Title III and IX and Section 937(c) of the Public Health Service Act and Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003.

Allocation Method: Research grants, contracts, and Other.

A. Program Description and Accomplishments

The Effective Health Care Program, launched in September 2005, supports the development of new scientific information through research on the outcomes of health care services and therapies, including drugs. By reviewing and synthesizing published and unpublished scientific studies, as well as identifying important issues where existing evidence is insufficient, the program helps provide providers, clinicians, policy makers and consumers with better information for making informed health care treatment decisions. In this program, AHRQ seeks an emphasis on timely and usable findings, building on the thoroughness and unbiased reliability that have been hallmarks of efforts so far. Equally important is broad ongoing consultation with stakeholders which helps ensure that the program responds to issues most pressing for health care decision makers. Collaboration is also a key principle of the program and AHRQ works closely with many agencies of DHHS to identify topics for research under the program and to communicate findings, including identified research gaps.

One important measure the Effective Health Care Program uses to evaluate its success is the amount of evidence made available to the public. In FY 2006, the program released four systematic reviews and one summary guide. In FY 2007, the program released four systematic reviews and eight summary guides. Four new research reports including a user's guide to registries evaluating patient outcomes and a Medical Care journal supplement on emerging methods in comparative effectiveness and safety were also released. In FY 2008, the program expects to release seven systematic reviews and eight summary guides. In addition, several research topics for systematic reviews and new research reports are in development and approximately twenty will be awarded in FY 2008. All reports produced by the program are available on the Effective Health Care Web site, http://www.EffectiveHealthCare.ahrq.gov. The Web site also includes features for the public to participate in the Effective Health Care Program. Users can sign up to receive notification when new reports are available. They can also be notified when draft reports and other features are posted for comment, and comments can be submitted through the Web site. The public is also invited to use the Web site to nominate topics for research by the Effective Health Care Program.

There is growing interest in, and attention to, enhancing the role of the Effective Health Care Program's research in our health care system. For example, Consumer Reports Best Buy Drugs, a public education product of Consumers Union, uses findings from the program to help clinicians and patients determine which drugs and other medical treatments work best for certain health conditions. The magnitude of the Effective Health Care program's impact is evidenced by the fact that the Consumers Union drug class reviews are downloaded at a rate of 110,000 per month. Over the course of the 2-year project, over 1 million reports have been downloaded. In addition to disseminating the consumer materials and reports via the Web site, Best Buy Drugs has an outreach program that links to existing groups with statewide reach and credibility throughout the medical community. The National Business Group on Health also uses findings from the Effective Health Care Program in their Evidence-based Benefit Design initiative to provide employers and their employees best available evidence for designing benefits and making treatment choices. Medscape and the American Academy of Family Physicians offers continuing medical education (CME) based on comparative effectiveness reviews and numerous other organizations use the findings in their deliberations on patient care, formulary design, and areas for needed research. These examples of organizations disseminating evidence from the Effective Health Care Program to their constituents are directly linked to key output (#1.3.25) listed in section D, Outcome and Output Tables.

Going Forward—The Effective Health Care Program of Comparative Effectiveness Research

In order to obtain the necessary information to assess more individualized responses to different treatments, more robust data are needed that include information on multiple chronic conditions, individual characteristics, and diverse populations. This is health care that works better for individual patients, based on new scientific evidence as well as information and system technologies that enhance care delivery and coordination. It aims to make complex information useful and readily applicable in clinical decision making and treatment. It means knowing what works, knowing why it works, knowing who it works for, and applying that knowledge for patients. Comparative effectiveness research, such as the research conducted in the Effective Health Care Program, provides the necessary science base for the realization of personalized health care. Integrating personalized health care into clinical practice will depend on the development of clinical evidence demonstrating that these approaches work for clinicians and patients. It will also depend on education and support for health care professionals to translate new knowledge into health care decisions.

Comparative effectiveness research is very important to undertake so that trade-offs, benefits and harms, and value of new treatments that are on-label and off-label are recognized. This information is critical for making informed decisions on what interventions and treatments to cover and use in providing high quality health care. For many diseases, however, there are differences in how different groups of patients respond to different treatments which require more complex comparative effectiveness studies. For example, some patients with elevated blood pressure respond to one type of therapy, such as a diuretic, and others respond better to beta-blockers.

Comparative effectiveness research that is undertaken to address individual differences in health outcomes can result in more targeted information about subgroups of patients and their response to different health care treatments. Specific information on how different subgroups improve or don't improve with different treatments will be extremely valuable in shaping health care decisions that yield much better health outcomes and improved value for our health care investments. This information will increasingly be more valuable in health care decision making because of the rapid development and penetration of genomic related diagnostic testing and treatments into the health care system without specific knowledge of their effectiveness and best application.

B. Funding History

Funding for the Comparative Effectiveness program during the last five years has been as follows:

Year	Dollars
2004	$0
2005	$15,000,000
2006	$15,000,000
2007	$15,000,000
2008	$30,000,000

C. Budget Request

AHRQ requests $30,000,000 for Comparative Effectiveness Research at the FY 2009 Estimate. These funds are being financed using PHS Evaluation Funds. In FY 2009, a total of $30,000,000 will support:

• Expanded outreach to stakeholders to engage them in the Effective Health Care Program. Topics for research in the Effective Health Care Program are selected and refined based on input from the public. The Effective Health Care Program considers public suggestions and examines the impact and relevance of the proposed topics to the Medicare, Medicaid, and SCHIP populations.
• Comparative and effectiveness reviews to inform decisions and promote Effective Health Care for Medicare, Medicaid and SCHIP Stakeholders. As shown in the output table (#4.4.5), FY 2009 funding will allow AHRQ to develop 9 Systematic Review. These outputs are a critical component to reach our long-term objective to improve a patient's quality of care and health outcomes through informed decisionmaking.
• Advancement of systematic review methodologies. The first step in this process is the posting of a draft Methods Guide for Comparative Effectiveness Reviews for public comment. The second is to edit the Guide and publish it, both on the Effective Health Care Web site and in the scientific literature.
• Effectiveness research to address important knowledge gaps confronting health care decisionmakers.
• Multi-center research cooperatives for comparative and clinical effectiveness studies.
• Translation and dissemination work of the John M. Eisenberg Clinical Decisions and Communications Science Center. As shown in the output table (#4.4.5), FY 2009 funding will allow for 10 Summary Guides to be produced.
• Building and enhancing the research and methodological capacity for conducting comparative and effectiveness research and for the integration of evidence into practice and decisionmaking.
• Evaluating new clinical data sources and important clinical information (e.g., lab values, blood pressure readings) and perform more rigorous comparisons of treatments to draw inferences about complex clinical outcomes. This will increase the ability for clinicians to provide the right treatment to the right patient.
• Develop a Protocol for Research on Analytic Performance and Effectiveness of Genomic and Other Laboratory Tests and Clinical Decision Support (CDS) Tools for Gene-based Test Information.
• Training and development of the new generation of comparative effectiveness researchers. It is expected that 3 to 4 career development awards will be made in FY 2008, with 3 to 5 years funding commitment for each award. Training and development activities will be closely tied to the programmatic strategic directions and the needs and challenges as identified by the Effective Health Care Program.

D. Performance Analysis

Long-Term Objective 1: Improve patient's quality of care and health outcomes through informed decisionmaking by patients.

#	Key Outcomes	FY 2004 Actual	FY 2005 Actual	FY 2006		FY 2007		FY 2008 Target	FY 2009 Target	Out-Year Target
				Target/Est.	Actual	Target/Est.	Actual
1.3.24	Quality and Effectiveness of Care Measures (subset of those endorsed by the National Quality Forum and analyzed in the National Health Care Quality Report)1	NA	List of priority conditions for research under Medicare Modernization Act released	NA	AHRQ launched new Effective Health Care Program, authorized under Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003	N/A	AHRQ created new Comparative Effectiveness Portfolio	1 Identify measures and limit to a subset based on priority conditions; work with AHRQ's planning, evaluation, and analysis contractors to limit to ~3 metrics to be tracked	1st and 2nd Qtr—Obtain baseline measures 3rd and 4th Qtr—Set targets for FY 2010-2019	2020 90% compliance on the three measures tracked

#	Key Outcomes	FY 2004 Actual	FY 2005 Actual	FY 2006 Target/Est. Actual		FY 2007 Target/Est. Actual		FY 2008 Target/Est.	FY 2009 Target/Est.	Out-Year Target/Est.
				Target/Est.	Actual	Target/Est.	Actual
4.4.5	Increase # of systematic reviews (SR) and summary guides available	NA	NA	NA	4 Strategic Reviews 1 Summary Guide	NA	4 Strategic Reviews 8 Summary Guides	7 Strategic Reviews 8 Summary Guides	7 Strategic Reviews 8 Summary Guides	2020 12 Strategic Reviews 15 Summary Guides
1.3.25	Increase # of organizations disseminating systematic reviews and summary guides to their constituents (Developmental)2	NA	NA	NA	NA	NA	NA	Work with AHRQ Effective Health Care's Eisenberg Center, Scientific Resource Center, and Stakeholder Group to identify methods for systematically identifying organizations that are disseminating systematic reviews and summary guides	1st and 2nd Quarter—Obtain baseline measures 3rd and 4th Quarter—Set targets for FY 2010-2019	2020 In development
1.3.26	Increase amount of evidence from the Comparative Effectiveness (CE) Portfolio policymakers use as a foundation for population-based policies (Developmental)3	NA	NA	NA	NA	NA	NA	Work with the Medicaid Medical Directors (AHRQ Learning Network) and Health Plans to identify methods for systematically reviewing policy decisions for references to evidence from the Portfolio	1st and 2nd Quarter—Obtain baseline measures 3rd and 4th Quarter—Set targets for FY 2010-2019	2020 In development
	Comparative Effectiveness Portfolio Appropriated Amount ($ Million)	$0	$15.0 M	$15.0 M	$15.0 M	$15.0 M	$15.0 M	$30.0 M	$30.0 M

^1. Baseline data will be established in FY 2009. Intermediate process measures will be used during the interim.
^2. Baseline data will be established in FY 2010. Intermediate process measures will be used during the interim.
^3. Baseline data will be established in FY 2010. Intermediate process measures will be used during the interim.

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