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Performance Budget Submission for Congressional Justification

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FY 2005: Research on Health Costs, Quality and Outcomes (HCQO) (continued)


Pharmaceutical Outcomes Portfolio

The Pharmaceutical Outcomes portfolio has three components:

  • The Centers for Education and Research on Therapeutics (CERTs).
  • The pharmaceutical outcomes research projects (all projects are complete).
  • Projects funded through investigator-initiated research and other AHRQ mechanisms.

There are other pharmaceutical studies funded by AHRQ that are included in the Patient Safety Portfolio rather than in this portfolio.

CERTs were originally authorized in the Food and Drug Modernization Act of 1997. The central objective of CERTs is to develop new and effective ways to improve the use of health care therapeutics throughout the Nation's health care system. Therapeutics includes drugs, biologics, and devices. CERTs combine support of basic health care research at research institutions (the centers) with concerted efforts to inform clinical practitioners and policymakers about the latest advances in therapeutics-related research.

The CERTs was authorized as a demonstration program, thus the program does not provide comprehensive coverage of research to improve safety and effectiveness.

Safety/Quality

Medication errors account for a significant and prominent aspect of patient safety issues and medication errors are represented in both the Patient Safety and Pharmaceutical Outcomes Portfolios. The Patient Safety Portfolio stresses errors of commission, whereas the Pharmaceutical Outcomes Portfolio covers both errors of commission and omission. The CERTs is viewed in the same context as the Centers of Excellence in Patient Safety. Two of the CERTs research centers have large Patient Safety grants with overlap between the two portfolios.

Goal: Develop knowledge and understanding of errors in health care by developing a patient safety research agenda specific to medications. This would be done in partnership with the CQUIPs program and the Investigators from the projects within the Patient Safety Portfolio that have a focus on medication. The focus of this agenda would be identification of areas of overlap and ascertainment of gaps in medication error research.

The Patient Safety program, the Institute of Medicine, the CERTs and others focus considerable resources on inappropriate and product overuse. The Pharmaceutical Outcomes projects and the CERTs have done a number of studies and tested programs that have focused on under use of products. Such studies have included studies of beta-blocker use in patients who have been discharged after myocardial infarction (heart attack). Neither AHRQ nor the CERTs have been able to systematically quantify the clinical and economic impact of under use.

Goal: Convene a multi-disciplinary group of experts in clinical medicine, epidemiology, economics and policy to assist us in identifying methods to determine how to measure under use and its cost and clinical consequences.

Effectiveness

The appropriate use of pharmaceutical agents is critical to effective, high quality, affordable health care. Understanding which agents work, for which patients, and at what cost can inform programs to manage the selection, utilization, and cost of pharmaceutical therapies and services within a changing health care environment. This information is often not available for pharmaceuticals because the FDA approval process requires pharmaceutical manufacturers to provide only evidence of safety and efficacy for one indication within rigidly controlled clinical trials.

CERTs and other pharmaceutical projects cover only a small portion of the potential universe of important questions of therapeutic effectiveness.

Goal: Develop a plan that identifies gaps in pharmaceutical effectiveness research and opportunities for implementation of evidence-based pharmaceutical usage. Using this information, develop a mechanism to increase the number of CERTs such that there are an adequate number of CERTs centers to comprehensively approach high priority questions of drug effectiveness.

Efficiency

The 1999 AHRQ reauthorization specifically adds cost-effectiveness research to the list of responsibilities for the CERTs. Each CERTs center will incorporate measures of cost effectiveness into core projects where feasible. (Core projects are defined as those funded completely or in part through AHRQ funding.)

Goal: Expand the component programs of pharmaceutical outcomes research. Program staff will work with the CERTs Coordinating Center to identify the economic component of the CERTs. This information will be consolidated into a Program Note. We will coordinate with the AHRQ Research Initiative on Cost Effectiveness (RICE) program to develop a dissemination plan for this information.

Accomplishments—CERTs

Since its inception in September 1999, the CERTs have developed a portfolio of more than 120 completed and ongoing studies, the results of which address important issues to advance the best use of therapies. Following are examples of how the CERTs seek to improve the Nation's health through the best use of medical therapies.

Patients with certain types of heart disease are not taking medicines that may save their lives

Aspirin is inexpensive and available over-the-counter. It greatly reduces the risk of heart attack, stroke, and related death in people with coronary artery disease (CAD). Similarly, beta-blockers, have been shown to help people with congestive heart failure (CHF). Data collected by the Duke University CERT showed that 87 percent of cardiac patients were using aspirin. This reflects, in part, the adoption of the recommendations from the AHRQ-sponsored U.S. Preventive Services Task Force. However, data collected by the Duke University CERT also confirmed that 13 percent of people with CAD were not receiving adequate therapy. The people with CAD who were not taking aspirin were almost twice as likely to die within 1 year as those who were taking aspirin. The news was only slightly better for people with CHF who were not taking a beta-blocker; they had 1.5 times the risk of dying compared with people who were taking the medicine. The Duke CERT is now investigating ways to get life saving medicine to people who need it. Programs to overcome barriers and save lives can be designed once more is understood about why people are not taking these medicines.

Monitoring anti-HIV drug levels

The effectiveness of drugs for women and children with HIV depends on the way they take the drugs and how their bodies handle the medicine. The University of North Carolina CERT developed a screening test for kids to measure the levels of anti-HIV drugs called protease inhibitors in the bloodstream. The test will determine whether the level of drugs is too high or too low as a result of the way the drug was taken or absorbed.

Research on the screening test had an unexpected, important finding: giving anti-HIV drugs with water to babies can speed the passage of the drugs through babies' systems before they have a chance to work. Giving drugs with infant formula greatly improves results. In another case, the test showed high levels of protease inhibitor in a child whose parent had readjusted the dose. Some patients were not getting their drugs at all. In one case, a child's mother was too ill herself to medicate her child, but the problem was only uncovered by the screening test. The test demonstrated that there might be a big difference between what a doctor prescribes and what is at work in the body. Providing this test to HIV-infected individuals can go a long way in ensuring that people are getting the level of drugs they need. The test also may help reduce the incidence of drug-resistant viruses and the cost of caring for patients with HIV.

Medicaid populations

Collectively, the CERTs centers have access to more than 20 unique data sources, representing over 50 million people, which they use to conduct population-based studies. Many of these studies have been conducted within Medicaid populations, including drug effects and use, prior authorization for use of nonsteroidal anti-inflammatory drugs (NSAIDS), prevention of falls, reimbursement for community providers of long-term care, and evaluation of a nursing-home dispensing change. In addition, studies are underway to gather information that Medicaid programs can use to make coverage and other policy decisions such as drug utilization review, economic effects of beta-blocker therapy in heart failure, efficacy and toxicity of drugs used in pediatric AIDS, prevalence of type 2 diabetes mellitus in children, drug interactions, fractures from osteoporosis, and other topics. The Vanderbilt CERT, in particular, has a long history of providing technical assistance to the Tennessee Medicaid program under a contract active since 1972.

Rethinking antibiotics before dental treatment

Many doctors prescribe antibiotics before dental treatment to reduce the risk of endocarditis (infection of the heart lining and valves). Because conventional wisdom suggests that patients with heart problems are at risk, this preventive measure has been recommended for more than 45 years. The University of Pennsylvania CERT conducted a study to evaluate and quantify the risk of such infection. They found that the incidence of infection remained the same even after introduction of widespread antibiotic prophylaxis, and that neither dental work in general, nor any individual procedures, was associated with infective endocarditis, with the possible exception of tooth extraction. The study also determined that flossing daily slightly reduced the risk of infection. Efforts are underway to have these findings incorporated into American Heart Association guidelines. These findings will affect an important source of unnecessary antibiotic use.

Performance Goals

Select to access Table 13 for performance goals of the Pharmaceutical Outcomes Portfolio.

Return to Accomplishments and Performance Analysis

Bioterrorism Portfolio

AHRQ, through its Bioterrorism activities, supports research in assessing and improving the U.S. health care system's capacity to respond to possible incidents of bioterrorism. These research projects examine an array of issues related to clinicians, hospitals, and health care systems, as well as linkages among these providers, local and State public health departments, emergency responders, and others preparing to respond to terrorist events and other public health emergencies. A third of the projects support regional planning and surge capacity issues. This work is an essential component to CDC and HRSA investments.
FY 2002 Bioterrorism Funding

In 2002, AHRQ received over $10 million from other agencies to assist them and to continue efforts to support the national preparedness for a bioterrorist event. AHRQ's current bioterrorism activities continue to support departmental activities in the three broad areas stated previously. Through various contract mechanisms, AHRQ-funded researchers are preparing tools and models that can be exported to States and interested entities for use in their bioterrorism preparedness planning projects. Examples of projects currently underway include:

  • Development of national guidelines for dispensing medications and/or vaccinating large populations in the event of a bioterrorist event.
  • A Web-based data tool and manual that facilitates health care systems' ability to monitor and track resources that would be needed to respond to a bioterrorist event. This work will be developed with rural hospitals as a model.
  • A Regional Health Emergency Assistance Line and Triage Hub (HEALTH) Model addressing the integration and communication with public health agencies and other facilities for efficient management of patient care during and after a public health emergency such as a bioterrorist event.
  • Development of a report that provides an overview of current knowledge on how disaster drills and training are conducted and evaluated for bioterrorism preparedness and a tool for evaluating disaster drills and training that can be disseminated to States and other interested groups.
  • Development of information technologies available in practice-based settings for surveillance of signs and symptoms of diseases that suggest bioterrorism in pediatric and adult primary care practices.
  • Convening of an AHRQ-sponsored conference focused on preparedness and disaster responses for pediatric patients.

Future research activities will address considerations relevant to rural preparedness, vulnerable populations, pediatric care issues, and public-private partnerships related to the use of information technology for surveillance, detection, notification alerts, and education of clinicians.

FY 2003 Bioterrorism Funding

In 2003, AHRQ received nearly $9 million, both in appropriated funds and funds from other agencies, to assist them and to continue efforts to support the national preparedness for a bioterrorist event. A total of approximately $5 million went to support research grants that examine and promote health care systems' readiness for a bioterrorist event through the development of new evidence, tools and models.

In light of recent events in the United States, there is considerable urgency to develop a public health infrastructure prepared to respond to acts of bioterrorism. AHRQ recognizes that community clinicians, hospitals, and health care systems have essential roles to play in this infrastructure. To inform and assist these groups in meeting the health care needs of the U.S. population in the face of bioterrorist threats, AHRQ supports research that emphasizes the following research objectives:

  1. Emergency preparedness of hospitals and health care systems for bioterrorism.
  2. Enhanced capacity needs of ambulatory care, home and long-term care, care of psycho-social consequences, and other related services during and after a bioterrorist event.
  3. Information technology linkages and emerging communication networks to improve the linkages between the personal health care system, emergency response networks and public health agencies.
  4. Novel uses of health care system training strategies that can prepare community clinicians to recognize and manage a bioterrorist event.
Accomplishments—Bioterrorism

AHRQ conducted two 1.5 day regional bioterrorism and health system preparedness workshops focusing on AHRQ supported bioterrorism research findings and promising practices implemented by States, localities and health systems. Five written briefs focusing on bioterrorism issues raised in the regional workshops and during the national Web-assisted audio conferences conducted by AHRQ will be prepared.

Through AHRQ's User Liaison Program (ULP), five 90-minute Web-assisted audio conferences were conducted throughout 2003 focusing on bioterrorism and health systems preparedness. Each conference focuses on AHRQ supported bioterrorism research findings and promising practices implemented by States, localities and health systems.

Performance Goals

Select to access Table 14 for performance goals of the Bioterrorism Portfolio.

Return to Accomplishments and Performance Analysis

Training Portfolio

AHRQ Training activities more broadly encompass research capacity development both at the individual and institutional level. The intent of these activities is to develop, broaden and diversify the talent pool conducting health services research. Prime focus is placed on ensuring that the cadre of researchers and institutions conducting research are responsive to gauging changes in the delivery of the health care system and responding to them in order to enhance quality, efficiency and effectiveness of health care and reduce patient errors. Ultimately, the success of these endeavors is to be measured in terms of developing productive researchers who in turn develop new knowledge that is ultimately translated or contributes to improvements in health delivery, policy or clinical care at the local, State, or national level.

In FY 2003, AHRQ continued its investment in the development of researchers through its National Research Service Award (NRSA) program, which supports the training of over 150 investigators annually, as well as through over 15 dissertation and 10 new career development awards.

In addition, AHRQ continued to embark on its mission to increase the geographic and demographic diversity in the pool of researchers through its Building Research Infrastructure and Capacity Program (BRIC) and Minority Research Infrastructure Support Program (M-RISP) programs, which respectively are designed to broaden the National capacity to conduct health services research across a wide range of states and in traditionally minority serving institutions. Currently, these projects support research largely focusing on health care disparities issues in the following States: Kentucky, Louisiana, Mississippi, New Jersey, Utah, Idaho, Montana, Nevada, Utah, Alabama, Hawaii, Texas, Georgia, Tennessee, North Carolina, and the District of Columbia.

Multi-staged goals are set for all of the above activities, with immediate, short-term success measured in terms of "graduation"—i.e., students completing training and centers of excellence being established. Intermediate objectives focus on research productivity and visibility of AHRQ-supported activities, with the goal to achieve long-term sustainability of initial investments through institutionalizing programs and the ability of new emerging centers of excellence to achieve independence. Long-term aims of these activities are to generate new knowledge, methods, and tools which car translated into improvements in clinical care, health care system delivery and health care policy at the local, State, regional or national levels.

Accomplishments—Training Portfolio

The demand for training in fields such as health economics, health care outcomes, and organizational/management health care research exceeds the supply. Employment among students trained is high. Virtually all of students supported through AHRQ training programs begun in 1986 (94 to 98 percent of postdoctoral students who have completed training) are gainfully employed in health services research or administration.

Three-quarters of all students graduating from AHRQ-sponsored training programs publish in refereed journals and up to 80 percent are first authors on their publications; remaining numbers are actively engaged in the conduct of applied research or its administration working in the government, private industry, or research foundations, and the health care delivery system.

Key recent publications produced by former students in journals such as the Journal of American Medical Association and the New England Journal of Medicine have been nationally acclaimed. For example one article drew attention to the need for greater use of computerized physician order entry systems and staffing of ward-based clinical pharmacists to curtail pediatric inpatient medical errors. Anther article found no difference in neonatal outcomes or HMO expenditures between early discharge programs and state-mandated program preventing early discharges.

Research or research methods produced by former students and in emerging centers of excellence in the BRIC and M-RISP programs supported by AHRQ have resulted in recent impacts, such as:

  • Contributing to the structure of CMS nursing home quality indicators on weight loss in nursing homes.
  • Influencing modifications in how HRSA measures primary care availability for future designations of shortage areas.
  • Leading to changes in New Hampshire's Board of Nursing re-licensure to enable tracking of the state's workforce to improve availability and diversity.
  • Providing a foundation for improvement in areas of neurological injury at eight medical centers in New England.
  • Adapting novel community and church-based recruitment efforts to:
    • Enhance participation in prevention research focusing on mammography use among women in a rural southern State.
    • Development of research partnerships among dental providers, State agencies and day care provides in the Mississippi Delta region that have resulted in enhanced delivery of dental services for poor children who prior to the establishment of these networks did not receive such services.
Performance Goals

Select to access Table 15 for performance goals of the Training Portfolio.

Return to Accomplishments and Performance Analysis
Return to HCQO Contents

Funding Summary

  FY 2003 Actual FY 2004 Enacted FY 2005 Request Increase or Decrease

Total

   Budget Authority

   PHS Evaluation Funds

 

$0

(252,663,000)

 

$0

(245,695,000)

 

$0

(245,695,000)

 

$0

+(0)

Full-Time Equivalents 272 272 272 0

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HCQO Funding History

Funding for the Research on Health Costs, Quality and Outcomes program during the last 5 years has been as follows:

Year Amount Full-Time
Equivalents
1999 $139,314,000 212
2000 $165,293,000 243
2001 $226,385,000 262
2002 $247,645,000 272
2003 Enacted $252,663,000 272
2004 Enacted $245,695,000 272
2005 Request $245,695,000 272

Sources of Research on Health Cost, Quality and Outcomes funding follow:

Year Budget
Authority
1 Percent
Evaluation
Total
1999   97,967,000   41,347,000 $139,314,000
2000 107,717,000   57,576,000 $165,315,000
2001 102,255,000 124,130,000 $226,385,000
2002 -0- 247,645,000 $247,645,000
2003 -0- 252,663,000 $252,663,000
2004 -0- 245,695,000 $245,695,000
2005 Request -0- 245,695,000 $245,695,000

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