Exhibit K. Significant Items in the House, Senate, and Conference Reports

FY 2005 House Report No. 108-636

Item: House (Report 108-188) p. 145

Disease spending—The Department is instructed to provide the Committee with a table detailing total spending by HHS, PHS, and NIH in fiscal years 1997 through the present on the following diseases: acute respiratory distress syndrome, arthritis, cancer, chronic obstructive pulmonary disease, depression, diabetes, heart disease, HIV/AIDS, kidney disease, liver disease, pneumonia and influenza, septicemia, and stroke. A functional breakdown of each showing the amount spent on research, prevention/education, and treatment should also be included for each of the diseases in the table. This table should also detail spending in both Medicaid and Medicare, as well as approximations for spending by insurance in the private sector, and private expenditures by individuals afflicted with these diseases. The Committee requests the table be completed no later than the end of February 2005.

Action Taken or To Be Taken

These tables were provided to the Committee under separate cover.

Item: Duchenne Muscular Dystrophy

1. House (Report 108-636) p. 122

The Committee encourages AHRQ to study and develop recommendations on the need for standards of care for individuals with Duchenne muscular dystrophy, allowing for input from external entities, including parent advocacy programs. In addition, the Committee recommends that AHRQ conduct a workshop on standards of care for the muscular dystrophies and coordinate this activity with national advocacy organizations dedicated to this condition.

Action Taken or To Be Taken

Duchenne muscular dystrophy is part of a group of genetic, degenerative diseases primarily affecting voluntary muscles. As DMD eventually affects all voluntary muscles, including the heart and breathing muscles, the care of individuals with the disease often requires the close collaboration of a clinical team with various specialties and patient families. The national advocacy organizations have provided an invaluable service to both the patient and the provider communities in raising the awareness of the diseases and patient needs, and in the calls to support more research.

AHRQ looks forward to working with all the stakeholders, including parent advocacy programs and national organizations in addressing the needs and standard of care for patients with Duchenne muscular dystrophy. Through AHRQ's small conference research grant program, the DMD national advocacy organizations could submit an application for expert conferences or workshops to deliberate and develop best practices and standard of care. While AHRQ is not in the position to make direct recommendations on clinical practices and care, AHRQ is indeed committed to partner with all stakeholders in developing scientific evidence and in facilitating the deliberation of best practices and standard of care.

Item: Study on Impact of utilizing Certified Surgical Assistants

2. House (Report 108-636) p. 122

The Committee encourages AHRQ to evaluate the outcomes, relevant patient care and financial impact of alternative methodologies of utilization and reimbursement of certified surgical assistances (CSAs) as recommended by the Government Accounting Office (GAO) and report such outcomes to the Committee.

Action Taken or To Be Taken

AHRQ recognizes the challenges faced by CMS in developing Medicare's reimbursement policies for assistants-at-surgery. As described in GAO Report 04-97 (January 2004), Medicare simultaneously pays for their services both by prospective payment for inpatients and by the physician fee schedule, which likely promotes inefficient care delivery. There also lacks uniform standards for education and experience for assistants-at-surgery. Separately, at present the States certify and license assistants-at-surgery. In response to the GAO report, CMS has indicated that the proposed policies require statutory change.

AHRQ will offer technical assistance to CMS as it formulates recommendations for the reimbursement of assistants-at-surgery. Should CMS undertake a demonstration project to test alternative reimbursement methods, AHRQ could assist in the design and analysis of its data, in assessing how to qualify and certify assistants-at-surgery, or what outcomes they attain.

Item: Umbilical Cord blood Donation

3. House (Report 108-636) p. 122

The Committee is aware of a significant gap in information that is available to expectant mothers regarding umbilical cord blood donation. Cord blood transplants are used to treat a number of conditions, especially diseases of the blood and lymph system such as leukemia and lymphoma. The Committee encourages AHRQ to study and recommend the appropriate point in maternity care at which to provide full information on all cord blood donation options.

Action Taken or To Be Taken

The utility of umbilical cord donation has not yet been ascertained and could be an appropriate area of inquiry for an evidence report by one of AHRQ's evidence-based practice centers. In addition, AHRQ could also work with clinical researchers and practice-based research networks to ascertain evidence-based recommendations regarding the appropriate timing of maternal counseling on the options of umbilical cord donations.

Item: Study to Examine Infused Biologicals

4. House (Report 108-636) p. 122, 123

The Committee is aware of an increasing number of non-chemotherapy infused biologicals that are under FDA review or are currently available for the treatment of diseases such as multiple sclerosis. The Committee encourages AHRQ to conduct a study examining changes in the market involving infused biologicals. The report should examine issues such as changes in market demand for non-chemotherapy infused therapies, whether health care providers have adequate capacity to meet increased demand, the cost to providers for meeting increased demands, geographical variations in access and meeting demand (including availability, capacity, barriers and variations in cost to rural providers). In addition, the Committee requests that the report examine demand for infused therapies by subspecialty including but not limited to neurology, hematology and rheumatology.

Action Taken or To Be Taken

AHRQ agrees with the Committee regarding the importance of understanding and tracking market changes related to non-chemotherapy infused biologicals, including their evolving use in the treatment of multiple sclerosis. The Agency will conduct an analysis using a database consisting of insurance claims from a commercially insured population of 5.6 million persons, which should provide information on changes in the market involving non-chemotherapy infused biologicals, capacity of health providers to meet the demand for these therapies, and cost and access to this type of care.

Item: Interactive Patient Education

5. House (Report 108-636) p. 145, 146

The Committee is aware of interactive, Web-based, user-friendly computer programs that have promise in making patients active participants and partners in decision affecting their health and healthcare. Such innovative use of information technology promises substantial advances in more fully informing and educating patients and has applications to informed consent for surgery and for clinical trials. In addition, it has potential applications to chronic disease management, organ donation, and end-of-life care decisions. The Committee encourages the Department through CMS and AHRQ to demonstrate ways in which this technology may improve the health care system.

Action Taken or To Be Taken

Through AHRQ's recent grant program, Transforming Quality through Health Information Technology, numerous grants were awarded in the area of interactive patient education. These grants include various populations, including vulnerable and chronically ill populations. It is expected that these community-based efforts will significantly impact on chronic illness care. For example, recent grants include an electronic health record that incorporated an interactive patient tool for diabetes care and an interactive program for renal transplant recipients. In addition to patient education, significant efforts are underway to provide interactive education for providers in rural and underserved settings. These grants target many different populations, including the visually impaired, geriatric care, inner city children with chronic illness, as well as different settings, including the Mississippi Delta, telehealth wound care, community health centers, and emergency departments.

In the future, we hope to build on these initiatives and diffuse successful efforts to other communities. In addition, the new AHRQ National Resource Center on Health Information Technology will work with all of AHRQ's grantees to share best practices in the area of interactive patient and provider education across the United States.

FY 2005 Senate Report No. 108-345

Item: Duchenne Muscular Dystrophy

1. FY 2005 Senate Report No. 108-345 p. 186

The Committee urges AHRQ to study and develop recommendations on the need for standards of care for individuals with Duchenne muscular dystrophy, allowing for input from external entities including parent advocacy programs. In addition, the Committee encourages AHRQ to conduct a workshop on standards of care for the muscular dystrophies and coordinate this activity with national advocacy organizations dedicated to this condition.

Action Taken or To Be Taken

Duchenne muscular dystrophy is part of a group of genetic, degenerative diseases primarily affecting voluntary muscles. As DMD eventually affects all voluntary muscles, including the heart and breathing muscles, the care of individuals with the disease often requires the close collaboration of a clinical team with various specialties and patient families. The national advocacy organizations have provided an invaluable service to both the patient and the provider communities in raising the awareness of the diseases and patient needs, and in the calls to support more research.

AHRQ looks forward to work with the all stakeholders, including parent advocacy programs and national organizations in addressing the needs and standard of care for patients with Duchenne muscular dystrophy. Through AHRQ's small conference research grant program, the DMD national advocacy organizations could submit an application for expert conferences or workshops to deliberate and develop best practices and standard of care. While AHRQ is not in the position to make direct recommendations on clinical practices and care, AHRQ is indeed committed to partner with all stakeholders in developing scientific evidences and in facilitating the deliberation of best practices and standard of care.

Item: Hospital-Based Patient Initiative

2. FY 2005 Senate Report No. 108-345 p. 186

The Committee encourages AHRQ to work with multi-site academic medical centers to identify and implement programs to improve patient safety in a hospital setting. The Committee is interested in patient safety improvements that are designed for rapid turnaround and for developing practical and replicable projects in the future.

Action Taken or To Be Taken

In FY 2004, AHRQ continued to manage and track findings, strategies, and useful products stemming from its portfolio of patient safety projects that were initiated in FY 2001. Independent of the recently awarded Healthcare Information Technology (HIT) grants, this is an effort that has received $165 million for funded research. A conservative estimate finds that at least 65 percent of these grants are relevant to patient safety issues that occur in multi-site hospital systems and that a vast majority of grants in this subset are academic medical centers. In addition to gaining a better understanding of the types of medical error that occur through it reporting demonstration grants, many of these grants have initiated specific interventions geared to reduce well known patient safety risk areas. To date, significant improvements have been reported in reducing adverse drug events, reducing post operative infections, and in reducing central venous catheter-associated infections. A large proportion of our grantees have requested no cost extensions to their grants since they are still analyzing their data; hence, AHRQ expects to report other significant findings by the close of the current fiscal year. Within this past year, AHRQ's Patient Safety Research Coordinating Center has undertaken efforts to more quickly identify practical tools and products (e.g., handheld devices, error detection algorithms, and simulators) that can make a safety difference for medical centers as well as busy doctors, nurses, and pharmacists. This effort is continuing in the current year and for the near term future.

Three other efforts should be noted. First, AHRQ sponsors an Integrated Delivery Service Research Network (IDSRN) program that focuses on rapid turnaround implementation research. This program includes several academic centers and has and continues to include patient safety projects. Second, in FY 2004, AHRQ initiated its knowledge transfer program in which it identifies forward-thinking healthcare systems that have expressed an interest in serving as "test-beds" for initiating best practices programs in patient safety. And third, AHRQ has initiated a $3 million Partnerships in Implementing Patient Safety grant program that will award grants to institutions willing to initiate practical and replicable interventions that increase patient safety. These grants, which may run up to two years in length, are scheduled to be awarded this summer, and may include academic medical settings. One product from each of these grants is a patient safety intervention implementation tool kit that will be generally available to the public for use in putting these programs into place in other settings.

Item: Multiple Sclerosis

3. FY 2005 Senate Report No. 108-345 p. 186

The Committee is aware of an increasing number of non-chemotherapy infused biologicals that are under FDA review or are currently available for the treatment of diseases such as multiple sclerosis. The Committee urges AHRQ to conduct a study examining changes in the market involving infused biologicals. The report should examine changes in market demand for nonchemotherapy infused therapies, whether health care providers have adequate capacity to meet increased demand, the cost to providers for meeting increased demand, as well as geographical and subspecialty variations in access and demand.

Action Taken or To Be Taken

AHRQ agrees with the Committee regarding the importance of understanding and tracking market changes related to non-chemotherapy infused biologicals, including their evolving use in the treatment of multiple sclerosis. The Agency will conduct an analysis using a database consisting of insurance claims from a commercially insured population of 5.6 million persons, which should provide information on changes in the market involving non-chemotherapy infused biologicals, capacity of health providers to meet the demand for these therapies, and cost and access to this type of care.

Item: Organ Donation

4. FY 2005 Senate Report No. 108-345 p. 187

The Committee recognizes that there is presently no formal mechanism to scientifically evaluate the efficacy of many new medications, devices, surgical techniques, and technical innovations that are being developed to improve organ preservation and maximize organ usage. The Committee encourages AHRQ to study and develop scientific evidence in support of efforts to increase organ donation and improve the recovery, preservation, and transportation of organs.

Action Taken or To Be Taken

AHRQ recognizes the importance of organ donation, and we are interested in addressing topics ranging from increasing registered donors and identifying the effectiveness of surgical and medical transplantation care. We have met with and will continue to collaborate with leading professional organizations in this effort, including the Association of Organ Procurement Organizations and leading transplantation societies.

Currently four grants on organ donation are underway. One study investigates the consent process for tissue donation. Three others are studying factors affecting the donor supply. One of these looks at barriers and facilitators of donation from a living donor, and another examines public attitudes and beliefs about organ donation and intends to develop educational materials to increase donation rates. In one grant the environmental and organizational factors that affect the ratio of actual donors to potential donors is explored.

In addition, in collaboration with the Office of Dietary Supplements, AHRQ is conducting a systematic review of the effects of omega-3 fatty acids on organ transplantation. Specifically, the nine questions being addressed relate to the areas of effect on: rejection or graft failure, renoprotection following kidney transplant, cardiovascular risk or events in transplanted patients, and risk of infectious complications. In addition, the review looks at any difference in effect by population subsets. The work was conducted by the Tufts-NEMC EPC. The final report has been received and release is expected in about 1-2 months.

Item: Provider Level Data

5. FY 2005 Senate Report No. 108-345 p. 187

The Committee understands that policies on databases and data elements are being developed in many State and local jurisdictions. The Committee urges AHRQ to conduct a study on the role and importance of provider level data for patient safety, quality of care, electronic health data interchange, and development of evidence-based practice standards. The Committee believes that such a report could serve as an important benchmark for jurisdictions developing database policies both in the United States and abroad.

Action Taken or To Be Taken

The Agency for Healthcare Research and Quality is presently carrying out an assessment of those data and terminology standards used in medical error reporting at the State and accreditation body levels that are derived predominantly from provider level data. The nine month effort is scheduled to be complete no later than June 30, 2005. This assessment comprehensively analyzes the data dictionaries and specific vocabularies used by such systems. It also analyzes and lays out a draft action plan of what would be required by these analyzed groups to meet IOM recommendations (Patient Safety, 2004).

Currently about 45 states collect discharge data from their hospitals and most of these contribute their data to AHRQ's Healthcare Cost and Utilization Project, a voluntary effort to create uniform databases for research purposes. The Agency undertook an evaluation of hospital discharge data to: (1) evaluate the value and impact of hospital discharge data and (2) help improve existing data systems by identifying new data elements for use in reporting and research. Preliminary results reveal that hospital discharge data are used widely for many purposes including but not limited to performing quality and patient safety assessments, conducting outcomes studies, assessing health system performance, studying inpatient treatment patterns, and facilitating required state and hospital reporting of statistics (e.g., maternal child health block grants). The final report should be available at the end of March, 2005.

Item: Unequal Treatment

6. FY 2005 Senate Report No. 108-345 p. 187

The Committee encourages the Agency to carefully evaluate the analysis, findings, and recommendations of the March 2002 Institute of Medicine report regarding the disparities of medical care delivery to minorities. In particular, the Agency should pursue creative ways to address this serious finding and improve health care delivery for African-Americans, those of Hispanic and Asian origin, Native-Americans, Alaskans and Native Hawaiians.

Action Taken or To Be Taken

The Institute of Medicine's landmark report on health care disparities included findings and recommendations that could help reduce disparities in the United States. Since the report was released, AHRQ has been actively addressing the IOM's recommendations in several different areas. First and foremost, the National Healthcare Disparities Report represents an important first step to increasing awareness of racial disparities. This annual report offers an opportunity to track data on health care access and quality among racial and ethnic minorities over time. Another related activity is the establishment of a research agenda, recently developed by AHRQ in collaboration with the OMH, on the relationship between cultural competence interventions and health care delivery and health outcomes. AHRQ has also maintained its commitment to a robust grant portfolio aimed at reducing health care disparities for minority populations.

A top priority of AHRQ's knowledge transfer and application activity is to partner with state policymakers, health care purchasers, and health care providers to decrease racial/ethnic and socioeconomic disparities in health care. Similarly, AHRQ's Decreasing Disparities Strategy Workgroup is working to develop and implement better processes to transfer knowledge from researchers to the appropriate provider, purchaser, and policymaker audiences in ways that reduce disparities in the quality and/or access to care for chronic illnesses, particularly diabetes and asthma.

AHRQ has also recently spearheaded a major public-private partnership, the National Health Plan Learning Collaborative to Reduce Disparities and Improve Quality. This collaborative effort with ten of the nation's largest health plans will focus on reducing disparities in health care for people with chronic conditions, particularly asthma and diabetes. It will also test ways to improve health plan capacity to collect and analyze data on race and ethnicity, match those data to quality measures, develop quality improvement interventions that close gaps in care, and produce results that can be replicated by these and other plans serving Medicare, Medicaid, and commercial populations nationally. This initiative will go beyond research and actively tackle racial and ethnic disparities in health care delivery.

The IOM report also recommended increased representation of minorities in health care. AHRQ intends to continue its commitment to funding such programs as the National African American Youth Initiative, the National Hispanic Youth Initiative, and the Minority Access to Research Careers (MARC) summer program. AHRQ also provides funds to minority students at the graduate level working on their dissertation or at the pre-dissertation phase through the Minority Research Infrastructure Support Program (MRISP).

Item: Effectiveness of Home Health Monitoring Devices

7. FY 2005 Senate Report No. 108-345 p. 185

The conferees are aware of the use of home health monitoring devices that guide patients and their physicians in managing chronic diseases, thereby avoiding rehospitalization and emergency room visits. The conferees encourage AHRQ to study the effectiveness of programs using these devices with patients suffering from chronic illnesses, compare monitored patients with non-monitored patients taking into account the number of hospitalizations, and quantify any overall cost reductions resulting from these programs.

Action Taken or To Be Taken

Home health devices are a key part of chronic disease management. These devices can range from the use of a scale, such as for someone with congestive heart failure, to much more complex technology. AHRQ recognizes the important role of home health monitoring devices in the promotion of patient-centered care and has supported a number of studies in assessing the effectiveness of such devices. For example, AHRQ is conducting a technology assessment on a home device for diagnosing sleep apnea that would replace the need for a formal study in a sleep lab. The US Preventive Services Task Force has reviewed the evidence on home uterine activity monitoring devices for detecting preterm labor. Blood glucose meters are an integral part of diabetes self-management, and AHRQ has ongoing studies on diabetes care. We are beginning an evidence report on care coordination, and aspects of self management may be incorporated.

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