1. Background
The Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999 provides $10 million for fiscal year (FY) 1999 to the Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS), for organ transplant activities, approximately $7.2 million more than the FY 1998 appropriation. The Senate Report "considers increasing the supply of organs, particularly livers, available for voluntary donation to be a top public health priority .... The [Senate Appropriations] Committee further expects that the additional funds be committed to those activities having the greatest demonstrable impact on donation rates and expects an operational plan from the agency within 60 days of enactment of this [Act]." This report fulfills the request for an operational plan.
Rapid medical and scientific advances have enabled many thousands of Americans to receive the gift of life through transplantation, but the number of donated organs still falls critically short of the need. While more than 20,000 Americans per year receive organ transplants, about 4,000 people die in the U.S. each year -- about 11 every day -- while waiting for a donated organ. Today, nearly 60,000 people are on the national organ transplant waiting list.
Although an estimated 8,000-15,000 deaths per year could result in organ donation, only 5,475 deaths resulted in donation in 1997. A 1996 study indicated that of all potential donations, 32 percent of families agreed to donation; 36 percent of families denied consent for donation; and in 27 percent of cases, either potential donors were not identified or no request was made to the family. (Another 5 percent eventually proved to be medically unsuitable.)
2. Progress to Date
In response to this urgent need for organ donors, Vice President Al Gore and HHS Secretary Donna E. Shalala on December 15, 1997, launched the National Organ and Tissue Donation Initiative (the "Initiative"), the goals of which are to increase consent to donation, maximize donation opportunities, and learn more about what works to increase donation and transplantation through carefully designed research efforts. More specifically, the Department has identified the following nine objectives as a framework for organizing efforts to increase donation:
- Increase the public’s willingness to donate.
- Increase and simplify opportunities to declare intent.
- Remove barriers to consent.
- Maximize identification of potential donors.
- Optimize donor management (for organ viability).
- Support individuals and families before, during, and after donation.
- Evaluate specific strategies to increase donation and transplantation.
- Support research to increase the knowledge base.
- Monitor and improve performance toward meeting the goals of the National Initiative.
In recognition of the need for collaboration and a multifaceted approach to the donation problem, the Department has placed priority on developing working partnerships with both public and private groups to carry out specific components of the Initiative. To date, a significant number of partnerships have been developed. Some examples of the Initiative’s major partnerships and corresponding activities are listed and discussed below:
- American Bar Association to document donation intentions.
- Institute of Medicine on the use of non-heart beating donors.
- Religious groups including the National Council of the Churches of Christ in the USA, the Presbyterian Church (USA), the General Conference of the Seventh-day Adventist church, the Union of American Hebrew Congregations, and other major faith groups on promoting donation through religious institutions and communities.
- American Medical Association on physician and patient education.
- American College Health Association and the University of Rhode Island in the application of a behavioral change model and research strategies to campus-based donation education campaigns.
- National Kidney Foundation on the National Donor Recognition Ceremony, the Donor Family Website, and the U.S. Transplant Games.
- Saturn Corporation/UAW, The Home Depot, Inc., and the American Red Cross on corporate-sponsored workforce and community campaigns.
- State government organizations (the Association of State and Territorial Health Officials, the Council of State Governments, the National Conference of State Legislatures, and the National Governors’ Association) on State activities to promote donation.
- CBS on providing a 10-second public service announcement (PSA) featuring Vice President and Mrs. Gore after the special donation-related movie Nicholas’ Gift.
- National Highway Traffic Safety Administration and the National Association of State Emergency Medical Services Directors in support of donor registries.
- Coalition on Donation in furthering national media campaigns.
Further, HHS, in partnership with the U.S. Office of Personnel Management, has implemented a government-wide campaign to encourage Federal employees to consider donation and -- as the country’s largest employer -- set an example for other public and private organizations and corporations. Activities thus far have included a satellite broadcast to Federal agencies; distribution of an implementation package to approximately 100 Federal agencies, including a memorandum from Vice President Gore and a video made especially for Federal employees; and ongoing technical assistance and support for individual agency and regional activities. As a result, a number of agencies, including HHS, are placing donation messages on employee pay stubs and including donation information in newsletters, presentations, and health fairs. In addition, Secretary Shalala recorded a radio PSA to promote organ and tissue donation in conjunction with the U.S. Postal Service’s issuance of the organ and tissue donation stamp in August 1998.
A continuing critical issue is the low rate of organ donation among minorities relative to their need. As a special effort to improve outreach with minority communities, HHS is working with minority-based organizations including the National Minority Organ and Tissue Transplant Education Program, the American Society of Minority Health and Transplant Professionals, the National Medical Association, and the United Network for Organ Sharing’s Minority Affairs Committee. In addition, HHS sponsored a 2-day meeting with the Congress of National Black Churches to work with African-American clergy to promote donation. Finally, HHS has published articles on minority donation and transplantation in the Journal for Minority Medical Students, the HHS Office of Minority Health’s Closing the Gap newsletter, and other minority publications.
3. Learning What Works
The Department believes that increases in donation, especially of the magnitude needed to approach the current demand, can result only from the application of tested theoretical approaches and models of behavior change to donation studies that are carefully designed and rigorously evaluated. Behavioral theories and models that have proved effective for large-scale behavior change related to other health issues such as preventing or reducing tobacco use, drinking and driving, and high cholesterol, have yet to be applied in a meticulous way to efforts to increase donation. The Department plans to promote the application of such models to projects to increase donation and to determine their utility in this field.
As reflected in the Initiative’s goals, the Department places high priority on research and evaluation. HHS has served, and plans to continue to serve, as a catalyst for the transplant community in emphasizing and encouraging carefully designed and rigorous evaluation components and research projects to ascertain effective procedures and models for increasing donation. On April 1-2, 1998, for example, the Department conducted a national conference to identify strategies that work in increasing donation and effective evaluation protocols for such interventions.
Through the Initiative, the Department has used other channels to stimulate donation. Most notably, in August 1998, the Health Care Financing Administration (HCFA) revised the conditions under which hospitals participate in the Medicare and Medicaid programs to require them to refer all deaths to organ procurement organizations (OPOs). This change was fashioned after the decidedly effective Pennsylvania State Law PA-102, which, in requiring hospitals to refer all deaths, resulted in a 41 percent increase in donation over a 3-year period in the eastern Pennsylvania area, a region already among the top ten performing OPOs.
4. Plans for Effective Use of Increased Appropriations
After providing adequate funds to support the Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients contracts and related activities, approximately $7 million will be available for organ donation activities. While the Department has made significant progress on actions to increase donation, these additional funds will bolster and enhance ongoing activities and partnerships. More important, the FY 1999 funding level will enable HHS to substantially expand the breadth and scope of efforts to explore new and innovative means for increasing donation.
In order to initiate or expand projects and activities to increase donation, HRSA plans to implement an extramural support program through competitively awarded grants and/or cooperative agreements. Approximately $4-5 million will be set aside for this program. A Federal Register notice announcing the extramural program and a Request for Applications will be available in early calendar year 1999. Organ procurement organizations and other non-profit entities (such as universities, professional associations, and units of State and local governments) will be eligible to apply. Applications will be peer reviewed and must contain a rigorous evaluation protocol and public dissemination component. Applicants that represent a consortium of organizations (such as a transplant-related organization and a research institution or group) will be given funding preference.
Top priority for the extramural program will be given to projects with the greatest potential for yielding a quickly verifiable and demonstrable impact on donation rates -- up to 70 percent of extramural program funds will be allocated to these types of projects. Examples include a variety of activities related to implementation of the HCFA Hospital Conditions of Participation regulation on required referral; living donation and other donor pool expansion efforts; increasing OPO performance; and targeting and involving minorities and special populations.
The remaining extramural program funds could include activities whose impact is likely to be more long range: behavioral research to better target and increase the effectiveness of public awareness campaigns and family consent discussions; educating health and other professionals; public awareness campaigns through annual events and the mass media; partnerships with State/local government; establishing new corporate and private partnerships; knowledge and information dissemination; exploring systemic changes; and support and evaluation of donor registries.*
Through a series of consultations, HRSA will confer with major transplant organizations and key individuals in the field to assure that program priorities and distribution of funds enumerated above are consonant with perspectives and needs of the larger transplant community.
Using the remaining resources, HRSA will award contracts to some partner organizations that have unique qualifications to conduct specific types of projects that are commensurate with the Initiative’s priorities. These projects may address some of the activities suggested above but are also expected to include: surveys to measure public attitudes and behaviors; aftercare for donor families; quantifying and diversifying the donor pool; and evaluating progress of the Initiative. Finally, the FY 1998 HHS Appropriations Conference Report encourages the HHS Secretary "... to conduct a comprehensive study of efforts underway at hospitals to improve organ and tissue procurement" including a focus on "... best practices for identifying donors and communicating with relatives of potential donors." HRSA will use a portion of the organ donation funds to address this issue in consultation with the General Accounting Office and HCFA, and congressional appropriations staff.
*Some parameters of the grant program and the background data have changed since submission of this report.