Legislation And Regulation

Although organ procurement rates experienced moderate, but steady, growth during the 1970s and early 1980s, the growth rate of the transplant waiting list was much larger. The gap between supply and demand caused patient groups to insist on a fair system of organ allocation that would provide equitable access to organs on a national level. Legislators responding to their constituents rushed to introduce bills to deal with this issue. Among the numerous legislators participating in this effort were Senators Ted Kennedy, Orin Hatch and Dan Quayle, and Representatives Dan Marriott, Edward Madigan and Henry Waxman. However, a bill introduced in 1983 by a Tennessee Democrat, Congressman Al Gore, ultimately changed the face of history with respect to organ procurement and transplantation. After several days of hearings, Congressman Gore drafted legislation in October 1983 titled the National Organ Transplant Act.1 The bill underwent numerous revisions until it was passed into law on October 19, 1984.

The National Organ Transplant Act was an amendment to the Public Health Service Act and it was a landmark statute for the transplant world. Most other federal legislation that followed has been tied to this important law. The law was divided into four parts—Titles I-IV. Title I established a task force charged with examining issues related to human organ procurement and transplantation, making an assessment of immunosuppressive medications used in transplantation, and presenting a report to the Secretary of the Department of Health and Human Services (DHHS). The task force held its first meeting in February 1985 and submitted its final report in April 1986. The task force outlined 60 recommendations in its 232-page published report.2 Table 4.1 lists several of the recommendations that directly affected OPOs.

Title II of the act dealt with organ procurement activities. Section 371 defined OPO qualifications including non-profit status, service area size, board composition and functional capabilities. Regulations regarding OPO qualifications have been revised several times, and current regulations will be addressed later in this chapter. Section 372 established the OPTN. The law provided initial funding for

Table 4.1 Task force recommendations affectingOPOs

◊ The enactment of uniform state laws for the determination of death

◊ The enactment of legislation requiring implementation of policies on organ donation and required request

◊ The development of minimum performance standards for OPOs

◊ Public education on organ donation targeted to minority populations

◊ Incorporation of organ procurement and transplantation into the curriculum of nursing and medical schools

◊ Certification of organ procurement specialists

◊ Certification of not more than one OPO in any one service area

◊ OPO governance similar to that described for the OPTN

◊ A single national system for organ sharing establishment and operation of the OPTN and set forth its qualifications, functions and board composition. Section 373 established a scientific registry to be awarded either by grant or contract. This registry was to include information on transplant outcomes. It was intended to allow patients and professionals to evaluate the scientific and clinical status of organ transplantation on an on-going basis. It has subsequently become the primary source of information for transplant patients to evaluate organ-specific outcomes at individual transplant centers. Sech tion 375 of Title II established the Office of Organ Transplantation. This office 4 was to coordinate organ procurement activities under Title XVIII of the Social I Security Act (Medicare), conduct public education about organ donation, provide technical assistance to OPOs, and provide an annual report to Congress on the status of organ donation. The Office of Organ Transplantation was later made a permanent part of the federal government when it was designated as a division

Table 4.2. Summary of qualification requirements for OPO designation

◊ Must qualify as a nonprofit entity

◊ Must have accounting procedures sufficient to maintain fiscal stability and to obtain payments from transplant centers for organs provided

◊ Must have an agreement with the Secretary of DHHS for Medicare reimbursement

◊ Must have an appropriately defined service area

◊ Must have a director and sufficient staff to be effective in recovering organs from the OPO's service area

◊ Must have a Board of Directors with authority to recommend donation policy and which meets composition requirements defined in these regulations

◊ Must have a documented working relationship to identify potential organ donors with at least 75% of the hospitals that have organ recovery capabilities and which participate in the Medicare and Medicaid programs

◊ Must have a systematic approach to identifying potential donors and acquiring all usable organs from those potential donors

◊ Must arrange for tissue typing

◊ Must have a system for allocating organs equitably in compliance with OPTN rules and with CDC Guidelines for Preventing Transmission of Human Immunodeficiency Virus Through Transplantation of Human Tissue and Organs

◊ Must arrange for transportation of donated organs to transplant centers

◊ Must coordinate its activities with area transplant centers

◊ Must have cooperative arrangements with tissue banks

◊ Must maintain data which demonstrates compliance with performance standards

◊ Must maintain data and records in a format which could be easily transferred to a successor OPO to facilitate uninterrupted service

◊ Must have procedures to assure confidentiality of patient records

◊ Must conduct professional education

◊ Must ensure that donor screening is performed by an appropriately certified laboratory to comply with OPTN standards and CDC screening guidelines

◊ Must assist hospitals in making routine inquiries about organ donation

◊ Must ensure that donors are tested for HIV markers in compliance with CDC guidelines and OPTN rules

◊ Must provide in a timely manner annual data concerning the population of the OPO's service area, the number of actual donors, and the number of renal and extra-renal organs procured and transplanted under the Health Resources and Services Administration (HRSA). It is now referred to as the Division of Transplantation (DOT) and has taken on the role of overseeing the OPTN contract.

Title III of the National Organ Transplant Act made it unlawful for any person to transfer any human organ for valuable consideration if the transfer affects interstate commerce. The term "valuable consideration" did not include reasonable reimbursement costs associated with the acquisition, preservation and transportation of organs acquired from deceased donors. Title IV dealt with the establishment of a national bone marrow registry.

The Omnibus Budget Reconciliation Act (OBRA) of 1986 defined the requirement that each OPO be certified by Medicare as a qualified OPO.3 The law further stated that OPOs be re-certified every two years by meeting qualifying criteria and performance standards established by the Secretary of the DHHS. It quickly became evident that numerous OPOs would not qualify under the initial qualifying criteria, especially those criteria related to the size of the OPO's service area and its donor potential. The ability of an OPO to qualify for certification was critical to its very survival. Any OPO not certified by October 1, 1987, would no longer receive payment for Medicare and Medicaid reimbursable expenses. As the deadline for certification drew near, OPOs across the country were merging and consolidating in order to meet the requirements. By the time the first certification process was completed, the number of OPOs had been reduced by approximately 40%.

Regulations related to OPO qualifying criteria and performance standards have been revised several times since 1986 and were last modified in November 2000. CMS still has not provided details about all elements of the new regulations, although one key element is the change in the certification cycle for OPOs from two to four years. The following are several key elements of the regulations used previously.4

For an OPO to receive Medicare and Medicaid reimbursement, it must be exclusively designated by CMS to operate in a defined service area. To be the designated OPO for a service area, the OPO must make application to CMS and meet certain requirements including the following:

• The OPO must be certified as a qualified OPO and must be a member of the OPTN.

• The OPO must have a formal agreement with CMS for reimbursement.

• The OPO must have working relationships with hospitals and transplant centers within its service area.

• The OPO must provide cost projections and cost reports to CMS to establish reimbursement rates and must provide data to CMS related to organ recovery activity.

• The OPO must also comply with defined performance standards in order to be redesignated.

• The OPO must provide extensive information regarding its service area, including the size and boundaries, the population, names of the counties, and names of the hospitals with organ recovery capabilities.

A summarized list of designation requirements is shown in Table 4.2. The gov-

Table 4.3. Summary of requirements for OPO board composition

Hospital administrators, tissue banks, voluntary health associations and either intensive care or emergency room personnel within the OPO's service area General public residing in the OPO's service area

A physician or individual with a doctorate degree in the biological sciences who is a specialist in histocompatibility

A physician who is a neurosurgeon or a specialist in neurology A transplant surgeon from each transplant center affiliated with the OPO

ning Boards of OPOs are also subject to composition requirements defined by the regulations. Table 4.3 lists the required member categories for an OPO's Board of Directors. Although an OPO may have more than one board, at least one of the boards must be composed in accordance with the regulations.

Performance standards for OPOs were less stringent prior to January 1, 1996. To meet those standards, each OPO had to demonstrate that it procured from its service area at least 23 kidneys per million population per year and that, of those procured kidneys, at least 19 per million population per year were transplanted.

The current performance standards implemented January 1, 1996, include five performance categories: 1) number of actual donors per million population; 2) number of kidneys recovered per million population; 3) number of extra-renal organs recovered per million population; 4) number of kidneys transplanted per million population; and 5) number of extra-renal organs transplanted per million population. To be redesignated, each OPO must achieve at least 75% of the national mean in four out of the five performance categories per year averaged over the two years prior to redesignation. In theory, all existing OPOs could meet these requirements without any being closed. However, several OPOs have already failed to meet these standards and have been closed. It is anticipated that as the lower-performing OPOs drop out via the redesignation process, the performance mean will continue to rise. On the positive side, a rising mean accomplishes the objective of having mandatory performance standards by raising the overall performance requirements of OPOs. On the other hand, some OPOs will fail and there is no guarantee that there will be an improvement of performance in a given service area with a different OPO. There are many who argue that the current performance standards are inappropriate because they are based solely on population and don't take into account population density, population demographics, trauma referral patterns or other factors that may influence organ donation activity but may be out of the sphere of control of the OPO. The AOPO and others who have criticized the validity of these standards are reviewing alternative standards that may more directly measure OPO performance. It is hoped that once CMS finally publishes the details of its November 2000 regulations, they will address the inadequacies of the January 1, 1996, performance standards.

The regulations also have a direct effect on hospitals. Each donor hospital in the OPO's service area must have an agreement to work with the OPO designated for the service area in which the hospital is located. The hospital may request a waiver to work with a different OPO but must demonstrate that the waiver will

Fig. 4.1. Organ supply vs. demand. Source: United Network for Organ Sharing

improve the rate of organ donation and ensure equitable access to recovered organs.

The regulations also deal with terminations of OPO agreements with CMS. OPOs may terminate voluntarily or involuntarily. If the OPO fails to meet the performance standards described above, CMS may terminate its agreement with the OPO. An OPO's agreement with CMS also may be terminated immediately if CMS determines the OPO is guilty of unsound practices.

A hospital-specific Medicare regulation implemented in August 1998 had a direct impact on OPO operations.5 All Medicare-certified hospitals must comply with this regulation or risk losing their agreements for Medicare reimbursements. These hospitals must have written agreements with a designated OPO and at least one eye bank and one tissue bank.

They must notify the OPO or the OPO's designated third party of all deaths or imminent deaths in the hospital. It is then the responsibility of the OPO to determine whether or not the individual is medically suitable for organ donation. It is also the responsibility of the OPO or a designated requestor trained by the OPO to discuss organ, tissue and eye donation with the family and obtain the appropriate consent documentation. The regulation also requires hospitals to educate their staffs about organ, tissue and eye donation issues, including identification of donors and maintenance until the recovery can occur.

Previously, hospitals in most states only called the OPO about potential donors. Criteria for such determinations were provided by the OPO. In reality, most OPOs were being notified about a small percentage of the total number of deaths in each hospital. The regulation placed a substantial burden on OPOs and hospitals. A direct impact on the OPO's level of staffing required to handle donor referrals and subsequent donations occurred, and many OPOs found it necessary to expand their telecommunications and information systems capabilities as the level of referral activity increased.

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