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FY 2009 Budget Justification
 

Organ Transplantation

FY 2007 Actual
FY 2008
Enacted
FY 2009
Estimate
FY 2009 +/-
FY 2008
BA
$23,049,000
$22,646,000
$23,049,000
+$403,000

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

FY 2009 Authorization Expired*
Allocation Method Contracts, Competitive Grants and Cooperative Agreements

* Sections 371 - 373 and Section 378 expired September 30, 1993. Sections 374 – 377, as amended by the Organ Donation and Recovery Act, authorize as such sums as necessary for FY 2009.

Program Description and Accomplishments
The National Organ Transplant Act of 1984 (NOTA), as amended, provides the authorities for the Program. The primary purpose of the Program is to extend and enhance the lives of individuals with end-stage organ failure for whom an organ transplant is the most appropriate therapeutic treatment. The Program works towards achieving this goal by providing for a national system, the Organ Procurement and Transplantation Network (OPTN), to allocate and distribute donor organs to individuals waiting for an organ transplant. The allocation of organs is guided by organ allocation policies developed by the OPTN with analytic support provided by the Scientific Registry of Transplant Recipients (SRTR). In addition to the efficient and effective allocation of donor organs through the OPTN, the Program also supports efforts to increase the supply of donor organs made available for transplantation.

Ideally, an organ would be available for every transplant candidate at the time the procedure would provide maximum benefit to the patient. Unfortunately, the demand for organ transplantation greatly exceeds the available supply of organs from deceased and living donors combined (see Figure 1). This trend is anticipated to continue, unless there is a major breakthrough in transplantation technology that will obviate the need for donor organs or the incidence of end-stage organ failure in the U.S. dramatically declines. This supply and demand imbalance is vividly evidenced by the 94,000 patients who were waiting for an organ transplant at the end of 2006. This number continues to increase as almost 98,000 patients were waiting for an organ transplant as of January 2008. Tragically, 6,700 individuals died, approximately 18 per day, in 2006 while waiting for a donor organ.

 

Figure 1:

This graph shows trends from 1993 to 2006 in the number of patients on the transplant waitlist, the number of transplants performed from deceased donors only, and the number of transplants from living as well as deceased donors. The number of patients on the transplant waitlist has grown steadily from about 30,000 in 1993 to over 94,000 in 2006. While the number of transplants performed has also grown over this time period, it has not grown as rapidly as the waitlist, leading to what is characterized on the graph as an “organ gap”.

In 2006, the most recent year for which program data are available, the Program demonstrated continued improvement in meeting its two long-term performance goals. The Program goals 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 the 2003 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. These Program goals were established in FY 2004.

The long-term goal of 42,800 deceased organs transplanted is based on converting an increasing percentage of the estimated annual number of deaths that meet ‘eligible donor’ criteria to actual donors. An ‘eligible donor’ is defined as any heart-beating individual meeting the criteria for neurological death, age 70 years or under, who has not been diagnosed with exclusionary medical conditions published by the OPTN. Beginning in September 2002, the OPTN started collecting this information from organ procurement organizations (OPOs) on a monthly basis. Based on these newly collected data, the number of eligible donors was estimated to be 12,000 in early 2004, when the performance goals were established. It took approximately two years to resolve definitional and data reporting issues to achieve an accurate accounting of the number of eligible donors. As the eligible donor data stabilized in late 2004, it became apparent that the number of eligible donors was closer to 11,000 and not the 12,000 used to develop the performance goals.

The Program has made impressive and sustained increases in the number of deceased donor organs transplanted. In 2003, the baseline year used for establishing the performance goals, 20,392 deceased donor organs were transplanted. In 2006, 24,461 deceased donor organs were transplanted, an increase of 20.3 percent above the 2003 baseline. The annual rate of growth between the end of 2003 and the end of 2006 was approximately 6.3 percent. In contrast, the annual rate of growth for the period between the end of 1993 and the end of 2003 was 2.5 percent. While the Program only met or exceeded its performance goal for this measure in FY 2004, the Program would have exceeded its performance targets in all three years if the targets had been properly calculated using the more accurate 11,000 number of eligible deaths.

The sustained improvements in the number of deceased donor organs transplanted can be largely attributed to the highly successful series of Breakthrough Collaboratives that began in 2003. The Breakthrough Collaboratives apply a proven methodology, created by the Institute for Healthcare Improvement (IHI), to successfully generate and sustain improvements in healthcare systems. The initial Collaborative, the Organ Donation Breakthrough Collaborative, was initiated in September of 2003. The goal of this Collaborative is to increase the organ donation conversion rate from 50 percent to 75 percent by 2013. A conversion rate is the number of organ donors meeting eligible donor criteria divided by the number of deaths that meet eligible donor criteria. HRSA partnered with the Nation’s 58 OPOs and donor hospitals having the highest number of eligible donors to test and implement changes to achieve this goal. As a result of this effective collaboration, the conversion rate increased to 64 percent by the end of 2006. Figure 2 illustrates the progress made towards closing the gap between the number of donors meeting eligible donor criteria and the number of deaths meeting eligible donor criteria. Figure 2 also illustrates that the number of eligible donors has declined from 11,417 in 2002 to 10,978 in 2007, a decline of 3.9 percent.

Figure 2:

This graph shows trends from 2002 to 2006 in the number of deceased individuals who meet eligible donor criteria and in the number of donors that meet eligible donor criteria. The graph shows that a larger percentage of deceased individuals who could donate orgrans are currently becoming organ donors (up from 50% in 2002 to 64% in 2006).

A major factor in increasing the number of organs transplanted is increasing the number of deceased donors. In 2006, the Program continued to make dramatic gains in the number of deceased donors. There were 8,024 deceased donors in 2006, an increase of 5.7 percent above the record-breaking number of 7,593 deceased donors in 2005. This continues a trend that began in 2004, the year after the Organ Donation Breakthrough Collaborative began. In 2004, there were 7,150 deceased donors, an unprecedented increase of 10.7 percent above the 6,457 number of deceased donors in 2003. This achievement continued into 2005 with 7,593 deceased donors, a 6.2 percent increase in the number from 2004.

The Organ Donation Breakthrough Collaborative was followed by the Organ Transplantation Breakthrough Collaborative beginning in October 2005. The purpose of this Collaborative is to increase the average number of organs transplanted from every deceased donor from approximately 3.20 to 3.75 by 2013. When the goals of the Organ Donation and Transplantation Collaboratives are achieved in 2013, approximately 35,000 deceased donor organs will be transplanted annually. This projection is consistent with the revised performance goal based on 11,000 eligible donors.

While additional increases can be achieved in the number of deceased donor organs made available for transplantation, there is an acknowledged upper limit to the number of deaths occurring each year that may result in organ donation. As mentioned previously, data from the OPTN indicate that approximately 11,000 of the 825,000 in-hospital-annual deaths meet the current ‘eligible donor’ criteria. Due to a number of factors, including a downward trend in the number of deaths that occur in hospitals, the aging of the population, and increases in chronic comorbidities that may exclude a deceased individual from becoming an organ donor, HRSA believes that the 11,000 ‘eligible donor’ upper limit may hold steady or actually decline in the coming years. A decrease between 2005 and 2006 is evident in Figure 2. If this trend continues, it will be increasingly difficult for the Program to meet the growing demand for deceased donor organs.

The Program also is making progress towards achieving its second long-term goal of increasing the total expected life-years gained for kidney transplant recipients in the first five years after transplant. The goal is to increase the total lifetime benefit achieved by all transplant recipients to 8,543 years by 2013. This target represents the expected additional life years gained five-years-post-transplant for the totality of individuals receiving a kidney transplant in 2013.

As with the first long-term goal of increasing the number of deceased donor organs transplanted, the life-years gained goal has annual targets representing incremental marginal gain (i.e., the gain per each kidney transplant recipient) and the total gain for all individuals receiving a kidney transplant in a given year. Therefore, achieving the long-term goal is dependent on the marginal improvement gained via each transplant performed, as well as by increasing the total number of kidney transplants performed. For FYs 2004 and 2005, the Program exceeded its performance goals for both the life-years gained per transplant and the total gained by all transplants. In 2006, the Program exceeded its per-transplant goal, yet fell 2.7 percent short of its goal for total expected life-years gained (4,913 years, actual vs. 5,048 years, goal). The reason the Program fell short of its total expected life-years gained was that the actual number of kidney transplants performed was less than projected. Had these original targets been developed using the 11,000 eligible donor benchmark, the total life-years gained goal would have been met.

Increasing the marginal improvement gained by each kidney transplant also can be positively influenced by revising how kidneys are allocated. Over the past several years, the OPTN has made incremental improvements to the kidney allocation policy. The current policy places great emphasis on the amount of time individuals wait for an organ transplant. The OPTN is currently in the process of developing a new allocation policy that will place greater emphasis on the net-lifetime survival benefit achieved by each kidney transplant. Depending on the final construct of this allocation policy, which must balance many issues in addition to survival benefit, it is anticipated that this new policy will improve the expected five-year survival benefit post transplant.

A 2004 PART analysis of the Organ Transplantation Program produced a rating of Adequate, finding that the Program has a clear purpose, is operated well, and meets an important need. The analysis indicated that the Program was having difficulty in achieving substantial progress towards its long-term goal of increasing the number of deceased donor organs transplanted.

Beginning in late 2003, the Program initiated a series of Breakthrough Collaboratives to rapidly increase the number of deceased donor organs made available for transplantation. The Organ Donation and Transplantation Collaboratives resulted in unprecedented increases in the number of deceased donor organ transplanted in CYs 2004 through 2006.

External Evaluation: In addition to internal monitoring of Program performance, a peer-reviewed article and a study by the Institute of Medicine have documented HRSA’s success in increasing the number of deceased donor organs made available for transplantation:

  • Sustaining the quality improvement efforts (in organ donation) is critically important. The Breakthrough Collaboratives have been instrumental in enhancing the coordination, processes and practices within hospitals and OPOs as well as among all of the relevant organizations and individuals” (Institute of Medicine (U.S.), Committee on Increasing Rates of Organ Donation, Organ Donation : opportunities for action / Committee on Increasing Rates of Organ Donation, Board on Health Sciences Policy; James F. Childress and Catharyn T. Liverman, ediors)
  • “Using a controlled pre/post study design, we compared conversion rates between hospitals that participated in the first phase of the Organ Donation Breakthrough Collaborative and controlled hospitals. The relative increase in the conversion rate in Collaborative hospitals between the preperiod and the final months was large—8 percentage points—and statistically significant” (Howard, D., Siminaoff, L., McBride, V., Lin, M. 2007. “Does Quality Improvement Work? Evaluation of the Organ Donation Breakthrough Collaborative.” Health Services Research 42-6: 21602173)

Funding includes costs associated with grant reviews, processing of grants through the Grants Administration Tracking and Evaluation System (GATES) and HRSA’s electronic handbook, and follow-up performance reviews.

Funding History

FY 2004 $24,632,000
FY 2005 $24,414,000
FY 2006 $23,049,000
FY 2007 $23,049,000
FY 2008 $22,646,000  

Budget Request
The FY 2009 Request of $23,049,000 is an increase of $403,000 over the FY 2008 Enacted level. This funding will continue support for the Organ Transplantation Program at the FY 2008 Enacted level.

The Program will continue to support Breakthrough Collaboratives in FY 2009 to make progress towards achieving a national organ donation conversion rate of 75% and transplanting an average of 3.75 organs from each deceased donor. To assist in providing sufficient transplant capacity to effectively utilize the additional number of deceased donor organs, the Program will continue to work with work with OPOs and transplant programs in FY 2009 to increase the capacity to transplant 35,000 deceased donor organs annually. The Program will also continue to provide support to States to implement and improve organ donor registries to allow individuals who choose to become organ donors to register their decisions.

The performance goals for the two major program measures for FY 2009 are:

  • transplant 27,683 deceased donor organs; and
  • achieve 5,873 expected life-years gained for the 5-year period post-transplant for kidney and kidney/pancreas transplants performed in 2009.

The following activities will be supported with the requested funding:

1. Contract to Operate the OPTN ($2.0 million) The OPTN is the critical nexus between individuals in need of an organ transplant and donor organs made available from deceased donors. Organ allocation policies developed by the OPTN prioritize the allocation of a deceased donor organ to individuals waiting for an organ. The policies are under continual review and refinement to achieve the best outcomes for patients. Given the critical shortage of organs, these policies strive to achieve the maximum benefit for the recipient as well as make the best use of donor organs. A competitive contracting process to operate the OPTN is held approximately every five years. UNOS has been the only contractor. The projected cost of operating the OPTN in FY 2009 is approximately $28.9 million. NOTA limits Federal support for the OPTN to no more than $2 million annually, which is approximately 7 percent of the projected cost of operation. The remaining 93 percent of costs are paid with revenues generated by fees collected by the OPTN to register patients on the national donor waiting list.

2. Contract to Operate the SRTR ($3.9 million) NOTA provides that the SRTR may be operated under contract or grant. HRSA has chosen to use a competitive contracting process to retain greater control over the work of the SRTR. The initial contract was awarded to the UNOS in 1987 and operated the SRTR until 2000, when it was awarded to the Arbor Research Collaborative for Health (formerly known as the University Renal Research and Education Association). 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 publishes data about OPO and transplant program performance and outcomes. This contract is fully-funded by HRSA.

3. Breakthrough Collaboratives to Increase the Number of Deceased Donor Organs Made Available for Transplantation ($3.8 million) HRSA will continue to support the highly effective Breakthrough Collaboratives to increase the number of deceased donor organs made available for transplantation and the capacity of both the OPO and transplant community to effectively and efficiently procure more deceased donor organs and for the transplant program community to perform more high-quality transplants. Logistics support to the Collaboratives is provided by contract that is awarded approximately every 2 years through a competitive contracting process.

4. Grants to Support Projects to Increase Organ Donation ($7.95 million) HRSA awards peer-reviewed grants to public and nonprofit private entities to: test and replicate new approaches for increasing organ donation, promote public awareness about organ donation, and to support development and improvements of state donor registries.

  • Social and Behavioral Interventions to Increase Solid Organ Donation grants to implement and evaluate social and behavioral strategies to increase family and/or individual consent for donation.
  • Clinical Interventions to Increase Organ Procurement grants focusing on clinical activities that begin after consent is determined or given at time of death and extend until transplantation. These donor-management-related 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.
  • State Donor Registry Support grants provide assistance to States to initiate and improve State organ donor registries. State donor registries are particularly useful in the approximately 47 States that have enacted "first person" consent laws, where the individual=s decision regarding organ donation takes precedence over the family's decision.
  • Public Education Efforts to Increase Organ and Tissue Donation grants fund the implementation of public education strategies to increase organ and tissue donation as evidenced by increased enrollment in State donor registries or by other means where a State registry is unavailable.

5. Cooperative Agreement to Provide Support for Reimbursement of Travel and Subsistence Expenses Towards Living Organ Donation ($2.0 million) This 4-year cooperative agreement awarded to the Regents of the University of Michigan in FY 2006 provides support for individuals to pay for travel and subsistence expenses associated with living organ donation. While the Program does not promote living organ donation and has no performance goals for increasing the number of living organ donors, this activity helps increase access to transplantation, particularly for individuals of lesser financial means. This grant program was authorized by the Organ Donation and Recovery Improvement Act (P.L. 108-216).

6. Activities to Support Public and Professional Education ($2.7 million) The Program, independently and in collaboration with the organ donation and transplant community and other stakeholders, supports a variety of public and professional education and outreach efforts designed to increase organ donation. Included in this category are projects designed to educate various segments of the population using communications options appropriate to the message and audience including: public service announcements broadcast via electronic media, printed materials, documentaries, educational programs for the classrooms, national organ donation events, and Web sites. HRSA initiated a new grant program in FY 2007 to support innovative strategies for outreach efforts to encourage public commitment to organ donation. 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. These activities are designed to increase the number of organ donors and number of deceased donor organs made available for transplantation.

7. 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 transplantation including issues related to: long-term donor and recipient outcomes related to living organ donation and organ and tissue safety.

# Key Outcomes FY 2004 Actual FY 2005 Actual FY 2006 FY 2007 FY 2008 Target FY 2009 Target Out-Year Target
Target Actual Target Actual
Long-Term Objective: Expand The availability of health care, particularly to underserved, vulnerable and special needs population
23.II.A.1 Increase the annual number of organs transplanted in accordance with projections until 42,800 (1) organs are transplanted in 2013.(Baseline—2003: 20,392) 21,949 23,249 25,651 24,461 27,877 Apr-08 26,314 27,683 2013:
42,800
23.II.A.4. Increase the average number of organs transplanted per “non-cardiac death” donor each year by 0.08 until the average of 4.00 (2) is achieved in 2013. 3.12 3.15 3.44 3.13 3.52 Apr-08 3.52 3.56 2013:
4

 

# Key Outcomes FY 2004 Actual FY 2005 Actual FY 2006 FY 2007 FY 2008
Target
FY 2009
Target
Out-Year Target
Target Actual Target Actual
Long-Term Objective: Expand The availability of health care, particularly to underserved, vulnerable and special needs population
23.II.A.5. Increase the average number of organs transplanted per “cardiac death” donor each year by 0.096 until the average of 3.00 (3) is achieved in 2013. (Baseline—2003: 2.04) 2.02 1.97 2.33 2.11 2.42 Apr-08 2.39 2.46 2013:
3
23.II.A.6. Increase the average number of life-years gained in the first 5 years after transplantation for deceased kidney/kidney-pancreas transplants by 0.003 life-years until the goal of 0.436 life-years gained per transplant is achieved in 2013.(Baseline—2003: 0.406) 0.433 0.44 0.415 0.42 0.418 Apr-08 0.421 0.424 2013:
0.436
23.II.A.7. Increase the total number of expected life-years gained in the first 5 years after the transplant for all deceased kidney and kidney-pancreas transplant recipients compared to what would be expected for these patients had they remained on the waiting list. (4) (Baseline—2003: 3,871) 4,427 4,758 5,048 4,913 5,477 Apr-08 5,543 5,873 2013:
8,543
  Increase the annual conversion rate of eligible donors in accordance with projections until a national conversion rate of 75 percent is achieved in 2013. (5)(Baseline—2003: 52.2%) 56.80% 58.90% 60.10% 63.90% 62.30% Apr-08 64.40% 66.50% 2013:
75.00%

# Key Outputs FY 2004 Actual FY 2005
Actual
FY 2006 FY 2007 FY 2008 Target/Est. FY 2009 Target / Est. Out-Year Target / Est.
Target/ Est. Actual Target/Est. Actual
Long-Term Objective: Expand The availability of health care, particularly to underserved, vulnerable and special needs population
23.II.A.2. Increase the annual number of “non-cardiac death” donors by 333 until the number of 9,251 “non-cardiac death” donors is achieved in 2013. (6) (Baseline 2003: 6,187) 6,759 7,032 6,920 7,375 7,253 Apr-08 7,083 7,317 2013:
9,251
23.II.A.3. Increase the annual number of “cardiac death” donors by 175 until the number of 2,018 “cardiac death” donors is achieved in 2013. (7) (Baseline 2003: 268) 391 561 793 647 968 Apr-08 593 658 2013:
2,018

 

# Key Outputs FY 2004 Actual FY 2005 Actual FY 2006 FY 2007 FY 2008 Target/Est FY 2009 Target / Est. Out-Year Target / Est.
Efficiency Measure
23.E. Decrease the total OPTN operating costs per deceased organ transplanted. (Baseline 2003: $924) (8) $933 $986 $975 $1,012 $960 May-08 $1,098 $1,117 2011:
$1,185
(9)
  Appropriated Amount ($ Millions) 24.623 24.414   23.049   23.049 22.646 23.049  

Notes

(1) This goal is primarily dependent on converting the number of eligible donors to actual donors. In establishing this performance goal in 2004 as a result of the PART analysis, the Program used the best newly collected information from the OPTN that indicated there were approximately 12,000 eligible donors. As a result of refinements in data collection definitions and more uniform reporting of data, the best estimate of the current number of eligible donors is 11,000. It is anticipated that this number will hold stable and may actually decline over the next several years. If 11,000 eligible donors in conjunction with the other changes described in the notes below were used in the projection of this performance measure, the target for 2013 will be 33,473 instead of the current 42,800. Targets for FYs 2008 and 2009 are based on the revised assumptions that are described in these notes.
(2) An analysis conducted in association with the Organ Transplantation Breakthrough Collaborative indicates that a long-term goal of 3.75 vs. the initial goal of 4.0 is more realistic. Targets for FYs 2008 and 2009 are based on this assumption.
(3) An analysis conducted in association with the Organ Transplantation Breakthrough Collaborative indicates that a long-term goal of 2.75 vs. the initial goal of 3.0 is more realistic. Targets for FYs 2008 and 2009 are based on this assumption.
(4) This goal is based on the projections for the total number of kidney and kidney/pancreas transplants performed using deceased donor organs. This estimate is related directly to performance measure 23.II, A.5 (see note 1). The number of deceased donor kidney and kidney/pancreas transplants is assumed to be 50 percent of the annual total number of deceased donor organs transplanted. Targets for FYs 2008 and 2009 are based on this assumption.
(5) This measure is implicit in the target for the number of deceased donor organs transplanted. However, since this measure is widely used by OPOs and the Department in assessing donor hospital performance and was a key measure used in the Organ Donation Breakthrough Collaborative, it is being included as a performance measure for purposes of transparency.
(6) The initial measure was developed based on the assumption that there were 12,000 eligible donors. Per note (1) above, the estimate is closer to 11,000. This measure assumes an increasing percentage of eligible donors to actual donors over time until a 75 percent conversion rate is achieved in 2013. The revised annual increase is 234 instead of 333. Targets for FYs 2008 and 2009 are based on this assumption.
(7) This measure was based on the assumption that the number of cardiac-death donors would be increased by 175 each year. Analysis conducted in association with the Organ Transplantation Breakthrough Collaborative indicates that a long-term goal of 10 percent cardiac death donors as a percentage of total deceased donors is a more realistic target. The revised annual increase is 0.57 percent. Targets for FYs 2008 and 2009 are based on this assumption.
(8) The OPTN cost per deceased donor organ transplanted is influenced by the number of deceased donor organs transplanted and the total cost of OPTN operations including both Federal and non-Federal support. The FY 2008 and 2009 targets were adjusted upward to reflect the revised target for the number of deceased donor organs transplanted (see note 1). Additionally, the cost of OPTN operations have increased to provide greater information technology capability and expanded OPTN member compliance review and oversight.
(9) The current OPTN contract ends in FY 2011.