National Institutes of Health: Kidney Disease Research Funding and Priority Setting
Published: 2016-12-19T00:00:00

Fast Facts:
About 17 percent of adults in the U.S. have chronic kidney disease. If this disease progresses to kidney failure, patients need dialysis or a kidney transplant to stay alive.
In 2013, Medicare spent nearly $31 billion to treat patients whose kidneys had failed. Given the high costs of this disease, we looked at how the federal government funds and prioritizes its research. We found that the National Institutes of Health spent $564 million on kidney disease research in 2015, an increase of 2.7 percent from 2014. These funds supported a broad range of projects, including research on kidney donation.

Highlights:
section_title: Why GAO Did This Study
paragraphs: An estimated 17 percent of U.S. adults have chronic kidney disease—the most common form of kidney disease—a condition in which the kidneys are damaged and cannot filter blood sufficiently, causing waste from the blood to remain in the body. Kidney disease patients may progress to ESRD, a condition of kidney failure, which can cause death without dialysis or kidney transplant. In 2013, the Medicare program—which pays for ESRD treatment—spent $30.9 billion to treat approximately 530,000 patients. Given the high cost of kidney disease in terms of health consequences and federal spending, GAO was asked to examine how the federal government funds and prioritizes kidney disease research. This report describes (1) the level of NIH funding for biomedical research on kidney disease, and for other leading diseases and conditions; and (2) how NIDDK sets priorities for kidney disease research.
To describe NIH funding for research on kidney disease and other diseases and conditions, GAO selected leading diseases and conditions (based on mortality and prevalence) and analyzed their levels of research funding based on NIH data for fiscal year 2015. To describe how NIDDK sets priorities for kidney disease research, GAO reviewed documents—including those on research portfolios and strategic planning—from NIDDK, NIH, and other relevant federal agencies. Also, GAO interviewed agency officials and private kidney care groups representing a broad range of perspectives.
section_title: What GAO Found
paragraphs: The National Institutes of Health (NIH), within the Department of Health and Human Services, is the primary federal agency that conducts biomedical research on kidney disease, as well as various other diseases and conditions. NIH's budget—$30 billion in fiscal year 2015—mostly funds extramural research that supports research personnel working at universities, medical schools, and other institutions. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)—one of NIH's 27 institutes and centers (IC)—has primary responsibility for kidney disease research. NIH funding for biomedical research on kidney disease in fiscal year 2015 was approximately $564 million—an increase of 2.7 percent from fiscal year 2014. NIDDK provided the majority (60 percent) of this funding, supporting a broad range of projects, such as chronic kidney disease, end-stage renal disease (ESRD) treatment, and kidney donation. GAO also reviewed NIH research funding levels for other diseases and conditions in the United States—those that are associated with high mortality or are among the most prevalent chronic conditions. GAO found that funding for fiscal year 2015 varied widely among these diseases and conditions—for example, from $28 million for emphysema to nearly $5.4 billion for cancer. This variation in funding reflects a range of factors, including each IC's mission, budget, and research priorities.
NIDDK obtains input from the broader kidney care community to develop its research priorities. To develop funding announcements that target high-priority research areas, NIDDK considers the kidney care community's input in the context of its ongoing work and its knowledge of the current state of kidney disease research. NIDDK's process for obtaining input from the kidney care community is iterative by design to help ensure that the institute's research priorities evolve to reflect the latest research developments and needs of the kidney care community.
Representatives from six private kidney care groups GAO interviewed generally agreed with NIDDK's kidney disease research priorities; however, some of the groups' members identified kidney disease topic areas they believe warrant more attention from NIDDK, such as a lack of kidney disease awareness in the general public. NIDDK agreed with this and other topics raised by the groups, and pointed out a variety of ongoing NIDDK programs that address these topics.
The Department of Health and Human Services provided technical comments, which GAO incorporated as appropriate.

section_title: Letter
paragraphs: An estimated 17 percent of U.S. adults have chronic kidney disease—the  most common form of kidney disease—a condition in which the kidneys  are damaged and cannot filter blood sufficiently, causing waste from the  blood to remain in the body. Kidney disease disproportionately affects  older, minority, and low-income individuals, and is often associated with  other health conditions, including heart disease. Diabetes and  hypertension—significant health problems in the United States—are the  leading causes of kidney disease. Individuals who have kidney disease  are at risk of progressing to end-stage renal disease (ESRD), a condition  of kidney failure, which causes death without dialysis or a kidney  transplant. Due to the scarcity of kidneys for transplants, treatment of  ESRD typically involves dialysis treatment for 3 to 4 hours, three times  per week, at a facility outside the home, and can significantly diminish  patients’ quality of life. Most individuals with ESRD are eligible for  Medicare regardless of age. In 2013, the Medicare program spent $30.9  billion to treat approximately 530,000 individuals with ESRD.
The National Institutes of Health (NIH), an agency of the Department of  Health and Human Services, is the primary source of federal funding for  biomedical research on kidney disease and various other diseases and  conditions. Within NIH, the National Institute of Diabetes and Digestive  and Kidney Diseases (NIDDK) is the institute with primary responsibility  for setting research priorities that guide the allocation of research funding  for kidney disease. Given the high cost of kidney disease in terms of  health consequences and spending, you asked us to examine how the  level of federal funding for kidney disease research compares to funding  for other diseases and conditions, and how the federal government sets  priorities for kidney disease research funding. In this report, we describe  1.  the level of NIH funding for biomedical research on kidney disease,  and other leading diseases and conditions; and  2.  how NIDDK sets priorities for kidney disease research.
To describe NIH funding levels for biomedical research on kidney disease  and other leading diseases and conditions, we first identified diseases  and conditions with a high disease burden in the United States relative to  other conditions based on data from the Centers for Disease Control and  Prevention (CDC). Specifically, we analyzed CDC’s national survey data,  and interviewed CDC officials to identify conditions that had high  mortality, or were chronic conditions with high prevalence, or both. We  then matched the diseases and conditions we identified with fiscal year  2015 data—the most current available—from NIH’s Research, Condition,  and Disease Categorization (RCDC) system, which categorizes NIH  research projects (and associated funding) into categories that  correspond to diseases and conditions. We confirmed the  appropriateness of these matches with NIH officials, and clarified any  differences in definition between the diseases and conditions and the  associated RCDC categories. (See app. I for a more detailed description  of our methodology.) To assess the reliability of the data used in our  analysis, we interviewed knowledgeable NIH and CDC officials, and  reviewed documentation about the data sources and methods for  collecting the data. We determined that the data were sufficiently reliable  for the purposes of our reporting objectives. Given our focus on kidney  disease research funding, we also reviewed documentation and  interviewed officials from non-NIH federal agencies that are part of the  Kidney Interagency Coordinating Committee (KICC) and fund biomedical  research related to kidney disease: Agency for Healthcare Research and  Quality, CDC, Department of Defense, Food and Drug Administration,  and Department of Veterans Affairs. (See app. II for a summary of non- NIH kidney disease biomedical research activities and associated  funding.)
To describe how NIDDK sets priorities for kidney disease research, we  reviewed documentation relevant to its priority setting efforts and  interviewed NIDDK officials about their processes. To understand how  NIDDK officials work with other federal agencies engaged in kidney  disease research, we interviewed officials from the KICC agencies that  fund or conduct biomedical research and attended two KICC meetings in  March and June of 2016. We also interviewed officials from the three NIH  institutes that fund most of the kidney-related research after NIDDK: the  National Heart, Lung, and Blood Institute, the National Institute of Allergy  and Infectious Diseases, and the National Cancer Institute. To gain  insight into the extent to which NIDDK’s priorities align with those of the  kidney care community, we obtained the perspective of six private kidney  care groups representing professional societies, patient advocacy groups,  dialysis providers, and other kidney-care industries. We selected these  six groups because, together, they represent a broad range of  perspectives within the kidney care community. However, our summary of  these groups’ views of NIDDK’s kidney disease research priorities cannot  be generalized to the entire private kidney care community.
We conducted this performance audit from February 2016 to December  2016 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.
subsections: section_title: Background
subsections: section_title: Kidney Disease
paragraphs: The kidneys are the body’s filtration system that removes waste and extra  fluid from the blood. Further, the kidneys maintain electrolyte stability,  help to control blood pressure, and produce hormones to keep the body  and blood healthy. Kidney disease occurs when the kidneys become  damaged and can no longer filter blood like they should, often due to  diabetes or high blood pressure—the most common causes of kidney  disease. For most people, kidney disease unfolds slowly over many  years and often has no signs or symptoms until the disease is very  advanced, such that less than 15 percent of people in the late stages of  kidney disease are aware of their disease. However, early detection is  possible through blood and urine tests, which can delay or prevent the  progression of kidney disease. Treatment may include, for example,  taking medicines to manage high blood pressure to protect the kidneys.  However, even with treatment, kidney disease usually cannot be cured.  Instead, it may get worse over time leading to kidney failure, or ESRD,  which may lead to death without dialysis treatment or a kidney transplant.  While anyone can develop kidney disease, regardless of age or race,  African Americans, Hispanics, and Native Americans are at high risk for  ESRD, due, in part, to high rates of diabetes and high blood pressure in  these communities. Medicare provides health coverage for most  individuals with ESRD, regardless of their age. Medicare spending on  treatment for individuals with ESRD has almost doubled in recent years— from $16.2 billion in 2003 to $30.9 billion in 2013—as the number of  Medicare beneficiaries with this condition and annual Medicare spending  per person have increased.
section_title: NIH Institutes and Centers and Their Research Activities
paragraphs: NIH—which had a total budget of $30 billion in fiscal year 2015—is  comprised of the Office of the Director, and 27 institutes and centers (IC)  that focus on specific diseases, particular organs, or stages in life, such  as childhood or old age. Twenty-four of the 27 ICs receive specific  appropriations to support, plan, and manage their research programs.  Within NIDDK, the Division of Kidney, Urologic, and Hematologic  Diseases researches diseases of the kidney and also focuses on the  fields of urology and hematology. Specifically, the division’s areas of  kidney research include chronic kidney disease, ESRD, cystic kidney  disease, acute kidney injury, and kidney donation. NIDDK’s budget in  fiscal year 2015 was $1.75 billion, of which $430 million (25 percent) was  allocated to the division.
NIDDK and the other ICs accomplish their missions primarily through  extramural research conducted by scientists and research personnel  working at universities, medical schools, and other research institutions.  Most extramural research funding is provided for investigator-initiated  research projects for which researchers submit applications in response  to broad funding opportunity announcements that span the breadth of  NIH’s mission. In addition to the broad investigator research  announcements, ICs issue more narrowly scoped solicitations for  research targeting specific areas.
All extramural research project applications follow NIH’s process of peer  review, which was established by law, and includes two sequential levels  of review. The first level involves panels of non-governmental experts to  assess the scientific merit of the proposed science, and the second level  involves panels of non-governmental experts and leaders of non-science  fields, including patient advocates, that, in addition to scientific merit,  consider the IC’s mission and strategic plan goals, public health needs,  scientific opportunities, and the balance of the IC’s research across its  various divisions and centers.
section_title: NIH’s System for Categorizing Research Funding
paragraphs: In January 2007, Congress directed NIH to establish an electronic system  to categorize the research grants and activities of the Office of the  Director and the ICs. In response, NIH implemented RCDC in February  2008, which reports on the amount of NIH funding in a given fiscal year  associated with one or more categories of diseases, conditions, or  research areas. RCDC reports publicly on 265 of these categories. To  assign an NIH project to the appropriate categories, RCDC uses a  computer-based text-mining tool that recognizes words and phrases in  project descriptions. Projects may fall into one or more RCDC categories.  For example, a study on how diabetes leads to kidney disease would be  listed in the “diabetes” and “kidney disease” categories. The system  includes reporting tools that can be used to generate publically available,  web-based reports on total funding amounts for the research projects  related to each RCDC category.
section_title: NIH Funding for Kidney Disease Research Totaled $564 Million in Fiscal Year 2015; Funding Levels Varied across Leading Diseases and Conditions
paragraphs: NIH funding for biomedical research related to kidney disease totaled  approximately $564 million for 1,493 projects in fiscal year 2015—an  increase of 2.7 percent from fiscal year 2014. NIDDK provided the  majority (60 percent) of this funding; other ICs provided the remaining 40  percent of funding. In NIDDK, the average research project award was  about $345,000, and ranged from approximately $27,120 for the smallest  to $28.5 million for the largest. (See fig. 1.)
The kidney disease projects funded by each IC reflect their different  missions. As the lead NIH institute for kidney disease, NIDDK funds a  broad kidney disease research portfolio, while the other ICs fund kidney  disease research in more specific areas that relate to their missions. For  example, one component of the National Heart, Lung, and Blood  Institute’s mission is heart health, and as noted earlier, heart disease can  be a cause of kidney disease. Therefore, that institute funds research that  examines how kidney disease impacts cardiovascular health. Similarly,  the National Institute of Allergy and Infectious Diseases fulfills its  mission—to study immunology and infectious diseases—through kidney  disease research that primarily addresses how a patient’s immune  system responds to a kidney transplant, as well as the negative impacts  of chronic-autoimmune diseases on long-term kidney health. Although  NIH is the primary federal agency involved in biomedical research on  kidney disease, there are other federal agencies that conduct and fund  research in this area. Appendix II describes these agencies’ kidney  disease research efforts.
To provide context for the level of NIH research funding for kidney  disease, we also analyzed NIH funding levels for other leading diseases  and conditions in the United States—those that had high mortality, were  among the most prevalent chronic conditions, or both. The RCDC  categories corresponding to these leading diseases and conditions, which  are shown in table 1, are neither mutually exclusive nor exhaustive.  Categories do not exist for all diseases and conditions, and NIH officials  said that a project may be included in, on average, six RCDC categories.  For example, a $1 million project on “depression in older men with  diabetes” could be placed into each of four categories: (1) depression ($1  million), (2) aging ($1 million), (3) mental health ($1 million), and (4)  diabetes ($1 million). Therefore, while RCDC produces a complete list of  the funded projects included within a category, it is not designed to  produce non-overlapping assignment of projects or fractions of projects to  categories. In fiscal year 2015, NIH research funding varied across the  categories corresponding to the diseases and conditions in our analysis,  from $8 million for fibromyalgia to nearly $5.4 billion for cancer. (See table  1.)
The variation in research funding across the RCDC categories in table 1  reflects a range of factors, including differences in each IC’s mission,  congressional appropriations, and research priorities. An IC’s  appropriation sets the amount of funding available for the given fiscal  year. Furthermore, appropriations may include mandated spending for a  specific disease, as is the case, for example, for type I diabetes.
Research priorities can affect the amount of funding devoted to the study  of a particular disease. We previously reported that ICs considered a  variety of factors when setting research priorities and NIH officials  confirmed that this is still the case. The factors ICs consider when  setting research priorities include  scientific needs and opportunities—identifying those research areas  that have advanced such that additional research funding could yield  a breakthrough; gaps in funded research and investment, such as diseases that may  attract limited private sector research funding; burden of disease—the impact of a health problem—on a population,  as measured by indicators such as prevalence, mortality, and impact  on quality of life; and public health needs, such as an emerging public health threat that  needs to be addressed, like the Zika virus.
section_title: NIDDK Obtains Input from the Broader Kidney Care Community to Develop its Research Priorities
paragraphs: NIDDK works with the broader kidney care community to develop its  kidney disease research priorities by using a web-based forum, hosting a  variety of meetings for kidney disease stakeholders, and by assessing its  research portfolio. NIDDK considers the community’s input in the context  of the institute’s ongoing work and its knowledge of the current state of  kidney disease research to develop funding announcements that target  high-priority research areas that are not being adequately addressed.  According to NIDDK officials, NIDDK’s process for obtaining input from  the kidney care and scientific communities, and developing research  priorities is iterative by design to help ensure that the institute’s priorities  evolve to reflect the latest research developments and needs of the  communities. (See fig. 2.)
NIDDK established and maintains the Kidney Research National Dialogue  (KRND)—an open, interactive, web-based forum—to obtain input from  the kidney care research community. The KRND began in 2010 by  allowing participants to submit, comment on, and prioritize potential  kidney disease research objectives for the kidney care and research  community and to be supported by NIDDK through workshops and  initiatives. (See app. III for more information on the KRND.) With the help  of established researchers in the kidney disease field, NIDDK staff  reviewed and distilled the KRND submissions into kidney disease  research priorities that address a variety of topic areas such as improving  therapies for chronic kidney disease, promoting human studies to better  understand kidney function, and advancing dialysis technology and  research.
In addition to the KRND, NIDDK officials stated that the institute obtains  input for its research priorities by meeting with its advisory council, federal  agencies involved in kidney disease research, scientific researchers, and  private kidney care organizations.
NIDDK advisory council: According to NIDDK officials, an NIDDK  advisory council member with expertise in kidney disease research  annually presents NIDDK officials with what he or she views, based  on clinical or research experience, as the most pressing kidney  disease research priorities. In addition, council members help shape  the research priorities by peer reviewing research proposals.
Federal agencies: Through the KICC, representatives of the federal  agencies involved in kidney disease research meet twice per year to  present and discuss information on their agencies’ respective kidney  disease-related programs and activities. The KICC agencies also  discuss a specific kidney disease topic at each meeting, such as  improving access to kidney transplantation, chronic kidney disease  awareness, and determining gaps in kidney disease research.
Scientific researchers: NIDDK’s Division of Kidney, Urologic, and  Hematologic Diseases hosts four to six scientific kidney disease  meetings every year, according to NIDDK officials. These meetings  are largely attended by scientific researchers and also by private  kidney care organizations, pharmaceutical industry members, and  officials from other federal agencies. Past meeting topics have  focused on a variety of areas as they relate to kidney disease,  including clinical trials, health information technology, and precision  medicine.
Kidney care organizations: Throughout the year, NIDDK meets with  kidney care organizations that represent different factions of the  kidney care community (e.g., patient and provider organizations, and  professional societies) to discuss their kidney disease research  priorities. For example, of the six private kidney care organizations we  interviewed, five reported that they meet with NIDDK individually or in  the company of other private organizations on at least an annual  basis.
In addition to the stakeholder meetings, NIDDK officials told us that they  annually assess the institute’s research portfolio—including investigator  research projects—to identify research gaps. NIDDK then uses the input  obtained through the portfolio review, the KRND, and stakeholder  meetings to develop targeted funding announcements for NIDDK  research initiatives. For example, for one NIDDK research initiative—the  Kidney Precision Medicine Project—NIDDK officials expect to issue $33  million in grant funding between fiscal years 2017 and 2021 to increase  research related to acquiring and studying human kidney tissues. The  lack of research on human kidney samples was highlighted in the KRND,  suggested by an advisory council member at an advisory council meeting,  and discussed at two scientific research meetings.
Representatives from six private kidney care groups we interviewed  generally agreed with NIDDK’s kidney disease research priorities as  published in the KRND; however, all of the organizations’ representatives  identified kidney disease topic areas that they said warranted increased  emphasis by NIDDK. For instance, representatives from four of the six  groups we interviewed expressed concern over a lack of kidney disease  awareness in the general public. To mitigate this, representatives from  one group recommended additional research on identifying at-risk  populations that would benefit from kidney disease screenings. In  addition, some of representatives noted that additional outreach and research is needed to reduce the disparities associated with ESRD.  Specifically, rates of ESRD are 3.4 times higher in African Americans and  1.5 times higher in Hispanics than in whites. NIDDK officials agreed that  improving kidney disease awareness and reducing kidney disease  disparities were important issues, and pointed out a variety of ongoing  NIDDK programs related to these topics. For example, NIDDK  established the National Kidney Disease Education Program to raise  awareness and reduce disparities through a variety of efforts directed at  communities at high risk for kidney disease, patients, and professionals  working in the primary care setting. NIDDK officials also said that  NIDDK’s Kidney Sundays program is intended to address both kidney  disease awareness and disparities. Specifically, Kidney Sundays provides  kidney disease information to African Americans by raising awareness  within churches about the risks of kidney disease and the importance of  being tested for kidney disease. According to NIDDK officials, 134  churches across 25 states participated in Kidney Sundays in 2016.
section_title: Agency Comments
paragraphs: We provided a draft of this product to the Department of Health and  Human Services. The department provided us with technical comments,  which we incorporated as appropriate.
As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time, we will send copies to relevant congressional  committees and other interested parties. In addition, this report is also  available at no charge on the GAO website at http://www.gao.gov.
If you or your staffs have any questions about this report, please contact  me at (202) 512-7114 or curdae@gao.gov. Contact points for our Offices  of Congressional Relations and Public Affairs are on the last page of this   report. GAO staff who made major contributions to this report are listed in  appendix IV.
section_title: Appendix I: Leading Diseases and Conditions and their Corresponding National Institutes of Health Research Categories
paragraphs: To determine the leading diseases and conditions for our analysis of  National Institutes of Health (NIH) research funding, we identified  diseases and conditions that had high mortality, were chronic conditions  with high prevalence, or both. To inform our selection, we examined  results from national surveys conducted by the National Center for Health  Statistics, within the Centers for Disease Control and Prevention (CDC),  interviewed CDC officials, and examined related GAO work. To identify  diseases and conditions with high mortality, we used the CDC’s National  Vital Statistics Report on mortality list for 2014, the most current data  available. These data are based on nationwide, standardized reporting  using the International Classification of Diseases, Tenth Revision (ICD- 10) system, which provides the rules used to code and classify primary  and contributing causes of death, as well as the selection of the  underlying cause of death on death certificates. When mortality data were  reported for disease subcategories, we included the disease subcategory  in our analysis when it exceeded 42,773 deaths, which was the number  for the 10th leading cause of death (suicide). For instance, three  subcategories of cancer each caused at least 42,773 deaths in 2014, as  shown in table 2.
To identify a list of prevalent chronic conditions, we first identified a peer- reviewed paper authored by researchers at CDC (among other  institutions) that identifies a list of 20 chronic conditions that are likely to  be among the most prevalent. This paper—which we refer to as “the  OASH list,” because the work was led by a working group within the  Department of Health and Human Services’ Office of the Assistant  Secretary of Health (OASH)—was particularly well-suited for our work  due to several factors. Among these are that it includes a precise  definition of chronic illnesses: “conditions that last a year or more and  require ongoing medical attention and/or limit activities of daily living  (such as physical medical conditions, behavioral health problems, and  developmental disabilities).” In addition, the authors applied a clear  methodology in identifying their list of chronic conditions from three  sources: (1) the Centers for Medicare & Medicaid Services’ Chronic  Condition Data Warehouse; (2) the list of “Priority Conditions” identified  by the Agency for Healthcare Research and Quality’s Effective Health  Care Program; and (3) the Robert Wood Johnson Foundation chart book  Chronic Care: Making the Case for Ongoing Care. Though our list of  chronic conditions was primarily based on the OASH list, we compared it  with CDC’s leading causes of death list and the list of most prevalent  chronic conditions that CDC provided GAO in 2013. If a condition was  listed on the leading cause of death list or the 2013 list from CDC, but  was not present on the OASH list, we added it to our total list of  conditions to ensure that we did not omit any key chronic conditions.  This process resulted in a list of 35 leading chronic diseases and  conditions for which we requested prevalence estimates from CDC.
We requested the most recently available prevalence estimates for the 35  conditions from one or both of two CDC surveys: the National Health  Interview Survey (NHIS) or the National Health and Nutrition Examination  Survey (NHANES). NHIS contains data collected through personal  household interviews on a broad range of health topics. NHANES is  designed to assess the health and nutritional status of adults and children  in the United States, and combines interviews with clinical information—a  physical examination and laboratory tests. We used NHANES as the  basis for the prevalence estimate for a given condition, because NHANES  includes clinical information, which would capture diagnosed and  undiagnosed conditions. When NHANES data for a condition were limited  to the interview (self-reported) or not available for the 2013-2014 time  period, we relied on the data from NHIS. We obtained prevalence  estimates for adults in the United States for 25 of the 35 conditions. We  included in our analysis the 10 chronic conditions with the highest  estimated prevalence rate. (See table 3.)
For the diseases and conditions included in our analysis, we identified the  corresponding categories from NIH’s Research, Condition, and Disease  Categorization (RCDC) system, which categorizes NIH research projects  (and associated funding). First, we reviewed the ICD-10 codes associated  with each of these diseases and conditions. We then identified the RCDC  categories that corresponded to the list of diseases and conditions. We  confirmed the appropriateness of these matches with NIH officials, and  clarified any differences in definition between the diseases and  conditions, and the associated RCDC categories. Table 4 contains a  crosswalk between these categories and the disease and conditions in  our analysis. To assess the reliability of the data used in our analysis, we  interviewed knowledgeable NIH and CDC officials, and reviewed  documentation about the data sources and methods for collecting the  data. We determined that the data were sufficiently reliable for the  purposes of our reporting objectives.
section_title: Appendix II: Federal Funding for Kidney Disease Biomedical Research by Agencies Other than the National Institutes of Health
paragraphs: The following is a summary of biomedical research on kidney disease  conducted by federal agencies outside the National Institutes of Health  (NIH): specifically, agencies that are part of the Kidney Interagency  Coordinating Committee (KICC), as well as the Patient-Centered  Outcomes Research Institute (PCORI). For the purposes of this report,  we defined biomedical research as consisting of (1) basic research, which  involves laboratory studies that provide the foundation for clinical  research; (2) clinical research, which includes patient-oriented research,  epidemiologic and behavioral studies, and outcomes and health services  research; and (3) translational research, which can involve enhancing the  adoption of clinical best practices in the community. Where available, we  also provide information on funding associated with these kidney disease  research activities.
Department of Defense (DOD). DOD supports biomedical research on  kidney disease primarily through the Peer Reviewed Medical  Research Program, which funds research of high scientific merit and  direct relevance to military health, across a wide array of topic areas  directed by Congress. Two of the topic areas in fiscal year 2015 were  directly related to kidney disease: focal segmental  glomerulosclerosis—a disease in which scar tissue develops on the  parts of the kidneys that filter waste out of the blood; and polycystic  kidney disease—an inherited disorder in which clusters of cysts  develop primarily within the kidneys. According to DOD, the agency  funded eight research projects related to kidney disease within these  two topic areas in the amount of $7.1 million in fiscal year 2015. In  addition, the agency funded two fiscal year 2015 kidney disease- related research projects under the topic areas of cardiovascular  health and lupus in the amount of $2.8 million.
Department of Health and Human Services.
Agency for Healthcare Research and Quality (AHRQ). As part of  its mission to improve the safety and quality of health care, AHRQ  funds extramural research grants to study chronic kidney disease  in areas such as patient safety and disease management, and  assessment in patients with multiple chronic conditions. According  to ARHQ officials, in fiscal year 2015, ARHQ provided new or  ongoing funding to four kidney disease research projects in the  amount of $1.3 million.
Centers for Disease Control and Prevention (CDC). CDC  conducts numerous epidemiologic studies to determine risk  factors for the incidence and progression of chronic kidney  disease, and to research the burden of the disease in both the  general and specific populations. In addition, CDC’s Chronic  Kidney Disease Initiative includes a website that provides  information on the disease’s burden and risk factors. Lastly, CDC  is also collaborating with NIDDK to investigate using new kidney  disease markers to diagnose early kidney function decline.  According to CDC officials, the agency obligated approximately $2  million in fiscal year 2015 for kidney disease activities, including  biomedical research.
Food and Drug Administration (FDA). FDA is currently in year  three of a 5-year renewable grant to the Kidney Health Initiative  (KHI). Founded in 2012, the KHI is a public-private partnership  between FDA and the American Society of Nephrology. Through a  collaboration with over 75 member organizations—such as patient  organizations, pharmaceutical and biotechnology companies,  dialysis providers, and government agencies—the KHI aims to (1)  advance scientific understanding of the kidney health and patient  safety implications of new and existing medical products, and to  (2) foster development of therapies for diseases that affect the  kidneys. For instance, one of KHI’s current research projects  seeks to clarify clinical trial endpoints for dialysis vascular access  trials. Though FDA does not direct its grant to specific KHI  projects, FDA representatives participate on KHI’s board of  directors and can thereby influence research project funding  decisions. According to FDA officials, in fiscal year 2015, FDA  provided KHI with $500,000.
Department of Veterans Affairs (VA). In fiscal year 2015, VA  supported 107 kidney disease intramural research projects. For  example, a past VA study found that patients who took part in a  screening and education program for kidney disease before being  diagnosed with the disease were better prepared to live with the  disease and had significantly lower death rates than those who had  not taken part in the program. In addition, VA recently issued  guidelines (jointly developed with DOD), for the management of  chronic kidney disease. According to VA officials, the total VA  biomedical research budget in fiscal year 2015 was $589 million, of  which about $20.9 million was for kidney disease research.
PCORI. PCORI’s Board of Governors approved three extramural  research projects related to kidney disease in fiscal year 2015 for  funding totaling $14 million.
section_title: Appendix III: The Kidney Research National Dialogue
paragraphs: The National Institute of Diabetes and Digestive and Kidney Diseases  (NIDDK) established the Kidney Research National Dialogue (KRND) to  help inform its research priorities by obtaining input from the kidney care  research community. The KRND consists of three phases.
Phase 1 (2010—2013): KRND was an interactive, web-based forum  that allowed participants to submit, comment on, and prioritize  potential kidney disease research priorities. Participants were asked  to categorize their ideas into 12 topic areas, such as chronic kidney  disease, acute kidney injury, and end stage renal disease. According  to NIDDK’s website, the KRND had over 1,600 participants from more  than 30 countries.
Phase 2 of the KRND (2011—2014): NIDDK invited research experts  to participate in one of 12 topic-specific working groups. Each group  was charged with fully assessing the postings from phase 1 of the  KRND, identifying research gaps, and developing a potential strategy  for moving the field forward. Each working group published their  priority recommendations in the Clinical Journal of American Society  of Nephrology. The groups’ papers covered the following 12 topics:  1.  Overview of the KRND  3.  Acute Kidney Injury  4.  Defining Kidney Biology to Understand Renal Disease  6.  Improving Chronic Kidney Disease Therapies and Care  7.  Propagating the Nephrology Research Workforce  8.  Pediatric Kidney Disease: Tracking Onset and Improving Clinical  9.  Glomerular Disease  10. Filling the Holes in Cystic Kidney Disease Research  11. Translational Research to Improve Chronic Kidney Disease Outcomes  12. The KRND: Gearing Up to Move Forward
Phase 3 (2014—present): NIDDK officials continue to seek comments  on the priorities articulated in the 12 topic papers through comments  on PubMed Commons (an NIH-funded open, web-based platform).  NIDDK officials told us that, to date, they have not received any  comments.
section_title: Appendix IV: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Will Black (Assistant Director),  Kristeen McLain (Analyst-in-Charge), Jesse Elrod, and Alison Smith  made key contributions to this report. Also contributing were Hayden  Huang, Drew Long, Yesook Merrill, Vikki Porter, and Emily Wilson.