BOX 4-1

Issues in Allocation and Distribution of Organs

Equitable Access to Transplantation: Medical, technical, ethical, and other issues arise in the referral for transplantation, admission to the waiting list, and selection to receive a donated organ. The criteria for each of these actions continue to need close attention by both professionals and the public to ensure equity. Particularly important is the role of the so-called green screen (which screens for insurance coverage and the ability to pay for the transplant) for nonrenal transplants and, often relatedly, the problems of access faced by minority populations.


Access to Immunosuppressive Medications Following Transplantation: Immunosuppressive medications, estimated to cost more than $10,000 per patient annually, are needed for the rest of the patient’s life after transplantation; their discontinuation can result in organ rejection and the need for retransplantation (Chisholm and Garrett, 2001). It has been estimated that medication noncompliance results in the loss of 13 to 35 percent of transplanted kidneys (Yen et al., 2004), but it is difficult to determine the extent to which noncompliance is tied to the high cost of medication. Medicare currently provides initial coverage for immunosuppressive medications after most solid-organ transplants that occur in Medicare-approved facilities. However, for many patients this coverage is limited to 3 years posttransplantation. An analysis of the effects of extending immunosuppression coverage from one to three years found improved graft survival (Woodward et al., 2001) suggesting the importance of uninterrupted access to immunosuppressive medications for optimal outcomes from donation. Research models that explored extending to lifetime coverage found improved transplant and economic outcomes (Yen et al., 2004).

For individuals who are eligible for Medicare because of age or disability, the Benefits Improvement and Protection Act (incorporated into Public Law 106-554) extended the benefits to lifetime coverage of immunosuppressive medications; however, this full coverage applies to only a fraction of total transplant recipients. Private insurers offer some patient assistance programs to provide medications to patients who lack Medicare coverage or the ability to pay, but these programs are highly individualized to specific insurance companies. Immunosuppressive medications offer the dual protection of maintaining the health of the recipient and protecting a scarce resource, a transplanted organ. A 2000 Institute of Medicine analysis of the effectiveness and cost savings of extending the Medicare coverage benefit found strong evidence for eliminating the time limits for coverage of immunosuppressive drugs for all solid-organ transplant recipients (IOM, 2000b).

CONTEXT OF THE CURRENT U.S. ORGAN DONATION SYSTEM

The U.S. organ donation system has evolved over the past half century, having been shaped by a series of federal and state laws and regulations, private-sector oversight, and individual hospital policies. The system has focused primarily on deceased donors with neurologic determination of death. More recently, living donation, which is rapidly increasing, has



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