Research on Health Costs, Quality, and Outcomes (HCQO)

¹ The number of FTE in FY 2010 includes an estimated 38 non-permanent FTEs to be compensated using Recovery Act funds.

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:

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Research Priorities

Comparative Effectiveness

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.

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 By reviewing and synthesizing published and unpublished scientific studies, as well as identifying important issues where existing evidence is insufficient, the program helps provide providers, clinicians, policy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 decisionmakers. Collaboration is also a key principle of the program and AHRQ works closely with many agencies of the Department of Health and Human Services (HHS) to identify topics for research under the program and to communicate findings, including identified research gaps.

One 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 released 7 systematic reviews and 12 summary guides including 2 guides that were translated into Spanish. In FY 2009, the program anticipates releasing 10 systematic reviews and 22 summary guides including some translated into Spanish. The targets for FY 2009 are reported in key output #4.4.5 in section D, Outcome and Output Tables. In addition, several research topics for systematic reviews and new research reports are in development and will be awarded for research in FY 2010.

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 key questions for research, 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. Also on the Web site is information about the expanded list of priority conditions, which guides the work of the program. The priority conditions are targeted to Medicaid, Medicare, and SCHIP (State Children's Health Insurance Program) beneficiaries (go text box below).

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. Over the course of the project, over 1 million reports have been downloaded. In addition to the consumer materials and reports being disseminated via the Web site, they are disseminated by 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.
• Omnicare, Inc., a leading provider of pharmaceutical care for the elderly, uses Effective Health Care Program summary guides as a tool for its consultant pharmacists and facilities, which are primarily nursing homes. Omnicare serves approximately 1.4 million residents in more than 15,000 long-term care facilities in 47 States, Washington, DC, and Canada.
• Su Clinica Familiar, a multi-office health clinic in south Texas, uses AHRQ's Effective Health Care Program summary guides for clinicians and patients to better address concerns of patients and as teaching resources for patients.
• 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.

Key output (#1.3.26) in section D, Outcome and Output Tables, increases the amount of evidence from the Comparative Effectiveness (CE) portfolio that policymakers use as a foundation for population-based policies and helps guide our relationship with the AHRQ-sponsored Medicaid Medical Director's Learning Network. Twenty State Medicaid Medical Directors report that they use Effective Health Care Program resources in a variety of ways. For example, they are incorporated into clinical guidelines created and disseminated by the States, incorporated into health plan educations materials, and used to inform coverage decisions and to set criteria for prior authorization.

B. Funding History

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

C. Budget Request

The FY 2010 President's Budget Request for Comparative Effectiveness is $50,000,000, maintaining the FY 2009 funding level. In FY 2010, a total of $50,000,000 will support:

• Planned dissemination 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. The Effective Health Care Program also considers the importance of a potential topic, such as how many people are affected and the level of uncertainty for doctors and other decisionmakers, whether the topic has already been covered by research that has been completed or is in progress, and for research reviews, the amount and type of research available.
• Systematic research reviews to inform decisions and promote effective health care. Research reviews from the Effective Health Care Program are reported in several formats. Comparative Effectiveness Reviews (CERs) and Effectiveness Reviews aim to provide comprehensive appraisal and synthesis of evidence. Updates apply systematic methods to bring CERs and Evidence Reviews up to date by reviewing the current literature. Technical Briefs aim to provide an overview of key issues related to an emerging diagnostic or therapeutic intervention. FY 2010 funding will allow AHRQ to continue to develop and make available to the public systematic reviews. 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. AHRQ understands the importance of and is fully committed to improving the consistency and quality of systematic reviews including comparative effectiveness reviews. AHRQ has been an international leader in this area. The science of systematic reviews is evolving and dynamic and AHRQ is looked to as a promoter of gold standard methods development and dissemination of best ways to do systematic review. Advancement of systematic review methodologies means identifying key issues at each step involved in researching, writing, and translating a systematic review, conducting research on these issues, and then providing recommended approaches for addressing these difficult, frequently encountered methodological issues. The Effective Health Care Program will soon publish the Methods Guide for Comparative Effectiveness Reviews, both on the Effective Health Care Web site and in the scientific literature. Additional methods workgroups will be formed and the Methods Guide will be expanded.
• Effectiveness research in priority condition areas to develop new scientific evidence regarding the effectiveness and long-term treatment effects of diagnostic and therapeutic interventions and to address important knowledge gaps confronting health care decisionmakers.
• Multi-center research cooperatives for comparative and clinical effectiveness studies in diabetes, cancer, and cardiovascular disease. In FY 2010, the multi-center research cooperatives will continue to work closely with AHRQ to carry out a coordinated and collaborative research agenda that addresses stakeholder questions about the comparative effectiveness, safety, and clinical effectiveness of therapies used in diabetes, cancer, and cardiovascular disease.
• Translation and dissemination work of the John M. Eisenberg Clinical Decisions and Communications Science Center. The Eisenberg Center will continue to facilitate access to and use of evidence-based clinical and health care delivery information and foster informed health care decisions by patients, providers, and policymakers. As shown in the output table (#4.4.5), FY 2010 funding will allow for 22 Summary Guides to be produced.
• Building and enhancing the research and methodological capacity for conducting comparative and effectiveness research using the most rigorous methods possible 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 performing more rigorous comparisons of treatments to draw inferences about complex clinical outcomes. This will increase the ability of clinicians to provide the right treatment to the right patient. Researchers will also work on the development and use of medical record and electronic administrative data systems.
• Continuing efforts to train and develop the new generation of comparative effectiveness researchers. It is expected that three or four career development awards will be made in FY 2010, 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 identified by the Effective Health Care Program.
• Consultation and collaboration with HHS agencies and other stakeholders to identify topics for research, communicate findings, identify research gaps, and ensure that the Effective Health Care Program is responsive to the most pressing issues for health care decisionmakers.

D. Outputs and Outcomes Tables

Program: Comparative Effectiveness

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

^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.

American Reinvestment and Recovery Act

Comparative Effectiveness Research

The American Reinvestment and Recovery Act (ARRA) was signed into law by President Obama on February 17, 2009. It is an unprecedented effort to jumpstart our economy, create or save millions of jobs, and put a down payment on addressing long-neglected challenges so our country can thrive in the 21st century. The Act is an extraordinary response to a crisis unlike any other since the Great Depression, and includes measures to modernize our Nation's infrastructure, enhance energy independence, expand educational opportunities, preserve and improve affordable health care, provide tax relief, and protect those in greatest need.

ARRA contains $1.1 billion for comparative effectiveness research. Of the total, $300 million is for AHRQ. Of the remaining funds, $400 million will be transferred to the National Institutes of Health (NIH), and $400 million will be allocated at the discretion of the HHS Secretary. The legislation calls on the Institute of Medicine to recommend research priorities for these funds and gather stakeholder input. A report is due June 30, 2009. In addition, the Federal Coordinating Council for Comparative Effectiveness Research has been created to offer guidance and coordination on the use of these funds.

AHRQ is gearing up to make the most of this additional funding. We are undertaking a process to determine what will be funded. We will work closely with NIH and the Office of the Secretary to ensure that we use these funds in the most effective manner and that we are coordinating our plans to maximize effectiveness of this important investment.

AHRQ will use ARRA funds to expand and broaden comparative effectiveness research activities initiated at the Agency in response to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, legislation designed to increase the availability of research that would inform the real-world decisions facing patients and clinicians. AHRQ's investments using ARRA funds will expand its Effective Health Care (EHC) Program. This effort will increase the national output of comparative effectiveness research; in addition, it may build research infrastructure and capacity, allowing future studies to address questions where data are currently not sufficient to provide guidance about competing alternatives and to improve the efficiency with which the research infrastructure is able to respond to pressing health care questions. Research activities will be performed using rigorous scientific methods within a previously established process that emphasizes stakeholder involvement and transparency, that was designed to prioritize among pressing health issues, and whose products are designed for maximum usefulness for health care decisionmakers.

More information on these and other ARRA programs can be found at http://www.hhs.gov/recovery.

Changes to Comparative Effectiveness Performance Measures Based on ARRA Funds

The measures currently used to report AHRQ's comparative effectiveness programs' performance will be used. Performance measure Targets and Results will be adjusted to reflect ARRA funds once AHRQ's spend plan for comparative effectiveness funding for ARRA has been approved and announced to the public. We will report outcome and outputs, to the extent possible, supported with funding appropriated under ARRA as an incremental change from those supported by regular appropriations.

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