Healthcare Systems

Organ Transplantation 

Authorizing Legislation - Sections 371 - 378 of the Public Health Service Act (P.L. 98-507 and P.L. 108-216), as amended.

FY 2008 Authorization........................................................................................................Expired*
* Sections 371 - 373 and Section 378 expired September 30, 2003. Sections 374 - 377, as amended by the Organ Donation and Recovery Act are authorized as such sums as necessary.

Statement of the Budget Request - The FY 2008 Budget of $23,049,000 is equal to the FY 2007 Continuing Resolution (CR).

Program Description - The Health Resources and Services Administration’s (HRSA) efforts to increase organ donation and transplantation mean the difference between life and death for tens of thousands of Americans and their families each year. The need for organ transplants continues to grow and this demand continues to outpace the supply of transplantable organs. During the past decade, the number of deceased donors increased between 2-3 percent annually while the annual growth rate in the number of individuals waiting for an organ transplant increased by approximately 8 percent. Even with the remarkable 10.8 percent increase in the number of deceased donors in 2004, followed by a 6.2 percent increase in 2005, there were still about 94,000 individuals waiting for an organ transplant at the end of 2006.

HRSA is responsible for the administration of the Organ Transplantation Program. The National Organ Transplant Act (NOTA) (P.L. 98-507), as amended, authorized the creation and operation of the Organ Procurement and Transplantation Network (OPTN), which facilitates the matching of deceased donor organs with individuals waiting for an organ transplant; the operation of the Scientific Registry of Transplant Recipients (SRTR), which facilitates the ongoing evaluation of the scientific and clinical status of organ transplantation; and grants and contracts to conduct projects designed to increase the number of organ donors. Additional program authorities were provided by the Organ Donation and Recovery Improvement Act (ODRIA) (P.L. 108-216) to help increase the number of organ donors and number of organs made available for transplantation. The key additional authorities provided by ODRIA include: grants to States to support organ donation awareness programs; grants and contracts to support public education and outreach activities designed to increase the number of organ donors, including living donors; the development and dissemination of educational materials to inform health care professionals and other appropriate professionals about organ, tissue and eye donation; grants to qualified organ procurement organizations and hospitals to establish programs to increase the rate of organ donation; financial assistance to living donors to help defray travel, subsistence and other incidental non-medical expenses; mechanisms to evaluate the long-term effects of living organ donation; and expansion of grant making authority to include public institutions.

Rationale for the Budget Request - The FY 2008 Budget of $23,049,000 is equal to the FY 2007 CR. The following activities will be supported with the requested funding:

1. Contract to Operate the OPTN ($2.0 million) NOTA prescribes that the OPTN shall be operated by a private, non-profit entity under Federal contract. The primary role of the OPTN is to increase the effectiveness and efficiency of organ sharing and equity in the national system of organ allocation, and to increase the supply of donated organs available for transplantation. The OPTN is the major mechanism by which HRSA implements the OPTN final rule (42 CFR, Part 121) including the development and monitoring of OPTN member compliance with OPTN policies and the OPTN final rule. The United Network for Organ Sharing (UNOS) located in Richmond, Virginia, is the contractor for the OPTN. The projected cost of operating the OPTN in FY 2008 is approximately $26 million. NOTA limits Federal support for the OPTN to no more than $2 million annually, which is approximately 8 percent of the current cost of operation. The remaining 92 percent of costs are paid with revenues generated by fees the OPTN assesses transplant programs to register patients on the national donor waiting list.

   Since 2002, the OPTN has produced noteworthy results because of improvements to national organ allocation policies including a 3 percent reduction in deaths among patients waiting for liver transplants while at the same time achieving a 24 percent increase in African-American recipients; an 18 percent increase in the number of lung transplants with a 30 percent reduction in lung waiting list deaths; and a 35 percent increase in the number of African-Americans receiving kidney transplants.

   The OPTN continues to monitor how effectively transplant programs comply with policies and an enhanced compliance monitoring process will go into effect in FY 2007. The OPTN has already implemented a hot line for patients and transplant programs to report potential problems. Additionally, the Scientific Registry of Transplant Recipients (SRTR) is now publishing program-specific organ acceptance and waiting list death rates so patients and healthcare professionals can better understand program performance. The OPTN also will continue refining its policies for surgeon and physician availability and new processes for swiftly identifying and addressing severe policy violations.

   As more resources become available, the OPTN will develop and implement sophisticated information systems to enable it to rapidly identify and address potential problems.

2. Contract to Operate the SRTR ($3.8 million) HRSA operates the SRTR under contract with the Arbor Research Collaborative for Health. The major purpose of the SRTR is to provide analytic support to the OPTN in the development and evaluation of organ allocation and other OPTN policies. Additionally, the SRTR provides analytic support to the Department, including the Advisory Committee on Organ Transplantation. In an effort to make information about the performance of the OPTN more widely available to the public, the SRTR also publishes information about organ procurement organization and transplant program performance and outcomes on the www.ustransplant.org website. This contract is fully-funded by HRSA.

3. Breakthrough Collaboratives to Increase the Number of Deceased Donor Organs Made Available for Transplantation ($4.5 million) In FY 2003, the Department announced a new initiative to rapidly increase the number of organ donors in hospitals where the greatest donor potential exists. The thrust of the Organ Donation Breakthrough Collaborative involved a systematic effort to rapidly replicate the proven best practices of hospitals and OPOs that consistently have high donor conversion rates. The Department established a national goal of 75 percent donor conversion for donor hospitals. A second Collaborative was launched in 2004 to ‘spread’ the learning gained from the initial Organ Donation Breakthrough Collaborative to more OPOs and hospitals. The combination of these two Collaboratives in addition to other efforts by the HRSA and the transplant community, generated record-breaking increases in the number of organ donors in the United States. The number of deceased organ donors increased by an unprecedented 10.8 percent and 6.2 percent in 2004 and 2005, respectively. Preliminary data indicate that there will be more than 8,000 deceased donors in 2006 – more than 5 percent over the record-breaking 7,593 number of donors in 2005. This increase in donation is the result of the steady increase in the organ donor conversion rate, which has increased from 52 percent prior to the Collaboratives to 64.5 percent as of September 2006.

   To complement the Organ Donation Breakthrough Collaborative, the Organ Transplantation Breakthrough Collaborative was initiated in October 2005. This Collaborative is designed to make more organs available for transplantation by increasing the number of organs procured from each deceased donor. The goal of this Collaborative is to increase the number of organs transplanted from each deceased donor from 3.06 to 3.75. If the goals of both the Organ Donation Breakthrough Collaborative and the Organ Transplantation Breakthrough Collaborative are achieved, the number of deceased donor organs transplanted will increase from 20,392 (the 2003 level prior to the start of the Organ Donation Breakthrough Collaborative) to 36,000 (a 77 percent increase). There were 23,249 deceased donor organs transplanted in 2005 (14 percent greater than the 2003 number).

   Work to further spread and accelerate the use of best practices for increasing organ donation and the number of organs transplanted per donor will continue in FY 2008, in expanded partnership with national organizations and partners. One of the consequences of the increases in the number of deceased donor organs made available for transplantation is the challenge to transplant programs to rapidly increase their program capacity to perform more transplants while at the same time providing quality care for transplant candidates and recipients. Recognizing this widespread challenge for transplant programs, HRSA plans to launch a new Collaborative in mid-2007 to help transplant programs effectively manage large increases in the volume of transplants while sustaining or increasing the quality of transplantation outcomes.

4. Social and Behavioral and Clinical Research Grants to Increase Organ Donation ($5.45 million) HRSA currently operates two demonstration grant programs designed to increase knowledge about practices that are effective in increasing the number of organs available for transplantation. The Social and Behavioral Interventions to Increase Organ and Tissue Donation grant program funds projects to implement and evaluate social and behavioral studies to increase family consent to donation and/or individual intent to donate. The Clinical Interventions to Increase Organ Procurement grant program focuses on clinical activities that begin after consent is determined or given at time of death and extend until transplantation. These clinical activities influence whether a potential donor actually progresses to become a donor and the number and quality of organs that may be procured for transplantation.

   The Social and Behavioral grant program has proven to be an effective incubator for testing and replicating new approaches for increasing the number of organ donors. Many of the best practices that are widely disseminated through the Breakthrough Collaboratives were developed under grants provided by this grant program. In addition, 33 peer reviewed journal articles have resulted from the projects funded through this program.

5. Cooperative Agreement to Provide Support for Reimbursement of Travel and Subsistence Expenses Towards Living Organ Donation ($2.0 million) ODRIA provides the authority to make grants to States, OPOs, transplant centers or other public entities for the purpose of providing for the reimbursement of travel and subsistence expenses incurred toward living organ donation for those potential donors without the financial means to pay these expenses. A four-year cooperative agreement was awarded to the Regents of the University of Michigan in FY 2006. Funding for this Cooperative Agreement will be supported at an annual average of $2 million.

6. Grants to Establish Programs Coordinating Organ Donation Activities of Hospitals and Organ Procurement Organizations to Increase the Rate of Organ Donations ($1.0 million) ODRIA provides the authority to award grants to OPOs and hospitals to establish programs coordinating organ donation activities. This grant program was initiated in FY 2005 to provide resources to support activities designed to improve the coordination of organ donation activities among donor hospitals and OPOs, including activities that complement the work of the Breakthrough Collaboratives.

7. Grants to Establish and Enhance the Usefulness of State Organ Donor Registries ($0.6 million) State donor registries take many forms and are designed to establish a central repository of residents’ intentions regarding organ donation. State donor registries are particularly useful in the approximately 43 States that have enacted ‘first person’ consent laws, where the individual’s decision regarding organ donation takes precedence over the family’s decision. This grant program, which was initiated in FY 2006, is designed to help States initiate new registries and support improvements to existing registries.

8. Support for Public Education Programs ($2.0 million) The Program, independently and in collaboration with the organ donation and transplant community and other stakeholders supports a variety of educational and public outreach efforts to inform the public about organ and tissue donation. This grants and contract funding supports projects designed to educate various segments of the population using mechanisms that include: public service announcements broadcasted via various communication media, printed materials, documentaries, curricula for the classrooms, national organ donation events, and Web sites.

9. Professional Education ($1.0 million) The Program supports education initiatives and other activities in collaboration with the OPTN and with major medical and professional organizations that are influential in organ and tissue donation including: the American Medical Association, the American Society of Transplant Surgeons, the American Society of Transplantation, the Association of Organ Procurement Organizations, the North American Transplant Coordinators Organization, and the American Bar Association.

10. Advisory Committee on Organ Transplantation and Interagency Activities to Support Donation and Transplantation ($0.7 million) The OPTN final rule (42 CFR § 121.12) authorizes the creation of an Advisory Committee on Organ Transplantation (ACOT) to provide recommendations to the Secretary on issues related to organ donation and transplantation. The Program supports the activities of the ACOT including the logistics for periodic meetings and analytic requirements. The Program also supports projects in collaboration with other agencies within the Department related to organ donation and transplant including issues related to: long-term donor and recipient outcomes related to living organ donation, xenotransplantation, and organ and tissue safety.

Funding levels for Organ Transplantation during the last five years reflect this effort and are as follows:

Outputs -

* Includes new grants and continuation grants from previous fiscal years; most project periods are three years in length.

Performance Analysis - In FY 2005, the most recent year for which data are available, the Program demonstrated continued improvement in meeting its two long-term goals. The outcomes for the Program are summarized by two overarching measures: (1) by FY 2013, increase the number of deceased donor organs transplanted to 42,800, an increase of 110 percent over baseline; and (2) by FY 2013, increase the total expected life-years gained for kidney transplant recipients in the first five years after the transplant to 8,543 compared to what would be expected for these recipients had they remained on the waiting list. For FY 2005, 23,249 deceased donor organs were transplanted, which was 263 (~ 1 percent) short of the 23,512 goal. For the second long-term measure, the Program exceeded the two annual goals that measure progress towards the long-term goal. The first of these two annual goals measures the increase in the average number of life-years gained for each individual in the first five years after transplantation for deceased kidney/kidney-pancreas transplants. The goal for FY 2005 was 0.412 life-years gained and the result was 0.440 life-years gained, 6.8 percent greater than the goal. For the second measure, which measures the total life years gained for all individuals receiving a kidney/kidney-pancreas transplant, the target was 4,641 total life-years gained and the result was 4,758, 2.5 percent above the target.

The Program continues to make dramatic gains in the number of deceased donors, which is a major component impacting the first long-term measure. There were 7,593 deceased donors in FY 2005, an increase of 6.2 percent above the record-breaking number of 7,151 in FY 2004, which was 7.6 percent above the FY 2003 baseline. In contrast, the annual rate of growth in the number of deceased donors was approximately 2-3 percent for the 10-year period including

FY 2003. These rapid gains in the number of deceased donors are largely attributable to the Organ Donation Breakthrough Collaborative initiated in October 2003. The goal of this Collaborative is to increase the organ donor conversion rate to 75 percent in the Nation's hospitals with greatest number of potential organ donors. In FY 2005, the conversion rate was 58.5 percent, which is 6.4 percentage points higher than the 52.1 percent rate in FY 2003, when the Organ Donation Breakthrough Collaborative began. In October 2005, a second breakthrough collaborative was initiated, the Organ Transplantation Breakthrough Collaborative. The focus of this Collaborative is to increase the number of organs made available from each deceased donor. The goal of this Collaborative is to increase the average number of deceased donor organs transplanted from each deceased donor from 3.06 to 3.75. These two Collaboratives have the potential to increase the number of deceased donor organs transplanted by 36,000.

A Program Assessment Rating Tool (PART) review of the Organ Transplantation Program was conducted for the FY 2006 Budget. The Program received a rating of Adequate. The Organ Transplantation Program has undertaken several targeted strategies designed to achieve results that will meet or exceed established PART goals that are designed to increase the number of organ transplants to patients who can benefit from an organ transplant. The program is focusing on two major strategic themes: (1) increasing the number of deceased donors, and (2) increasing the number of donor organs made available for transplant from each deceased donor.

Major activities underway include:

• Organ Breakthrough Collaboratives – Using the method developed by the Institute for Healthcare Improvement, this initiative is designed to rapidly spread best practices of organ procurement organizations and donor hospitals to increase the number of deceased donors and to increase the number of organs made available for transplantation from each deceased donor.
  
• Organ Procurement and Transplantation Network (OPTN) – The OPTN is working to revise that national kidney/kidney-pancreas allocation policy to optimize net lifetime survival benefit of kidney/kidney-pancreas transplantation. Additionally, the OPTN is working to improve the information technology and operations infrastructure of the OPTN to allow more rapid and efficient placement of deceased donor organs.
  
• Scientific Registry of Transplant Recipients (SRTR) – The Program will continue to fund the collection of information for all organ donors and transplant recipients to be used for public and professional information and policy research purposes.
  
• Organ Procurement Organization (OPO) Redesign Project – The Organ Transplantation Program is supporting efforts to help OPOs redesign their organizational structure and business practices to enable OPOs to effectively manage the functions associated with organ donation.
  
• Grants to Support Organ Donation – The Program will continue to support funding of grants to test new approaches to increasing organ donation.
  
• Public and Professional Education Programs – The Program will continue to promote organ and tissue donation through a variety of initiatives targeted to the general public and to medical and other professionals who are influential in the organ donation process.